[ summary of the invention ]
The application provides a catheter with antibacterial coating, the technical scheme that this application adopted as follows:
a catheter with an antibacterial coating, which consists of a guide part and a handheld part;
the guide part comprises a guide pipe and an elliptical soft head part, an opening is formed in the middle of the top of the elliptical soft head part, the upper part of the guide pipe is connected with the elliptical soft head part, the lower end of the guide pipe is connected with the handheld part, and the diameter of the guide pipe increases progressively along the extending direction from the upper end to the lower end; a plurality of flow guide lines are vertically arranged on the inner wall of the guide pipe in the longitudinal direction, and a plurality of plastic rings are horizontally arranged on the outer wall of the guide pipe in the transverse direction;
the handheld part comprises an inverted trapezoidal limiting part, a plug socket is arranged on the inverted trapezoidal limiting part and is in butt joint with the guide pipe, a urethral catheterization inner pipe body is arranged in the middle of the inverted trapezoidal limiting part, and the urethral inner pipe body is communicated with the guide pipe through the plug socket; the handheld part also comprises two air bags and two water guide pipes, the air bags are respectively fixed on two sides of the handheld part, the two water guide pipes are positioned on the inner side of the handheld part and are respectively positioned on two sides of the inner catheter body, one end of each water guide pipe is communicated with the air bags, and the other end of each water guide pipe is arranged in parallel with the inner catheter body;
the urine catheter is characterized in that a sealing and fixing part is arranged at an outlet at the lower side of the handheld part, three through holes are formed in the sealing and fixing part, and the inner catheter body and the two aqueducts penetrate through the through holes.
Further, triclosan molecules with an antibacterial effect are immobilized on the surface of the catheter inner tube body and the surface of the diversion line to form an antibacterial coating. TCS is used as a raw material required by preparation of the antibacterial coating, and the purity is 97%; the purity of the dopamine hydrochloride is 98 percent, the absolute methanol and the tris (hydroxymethyl) aminomethane are analytically pure, and the material of the diversion line is polyglycolic acid.
Further, the preparation method of the bacteriostatic coating comprises the following steps:
step 1, measuring 150mL of deionized water, adding 182.1mg of trihydroxymethylaminomethane into an aqueous solution to adjust the pH value of the solution to be alkalescent, and adding dopamine hydrochloride according to a set proportion after the trihydroxymethylaminomethane is stirred and dissolved to form a PDA solution;
step 2, dissolving a proper amount of TCS in ethanol to form a TCS ethanol solution;
step 3, mixing the two solutions to form a mixed solution, sealing the mixed solution, leaving air holes, and continuously stirring; after 24 hours, cutting the diversion line to a proper length, putting the diversion line into the mixed solution, and standing the solution in an oven at 37 ℃ for 24 hours; and taking out, washing with deionized water, and drying to obtain the antibacterial coating with PDA-TCS.
Through the embodiment of the application, the following technical effects can be obtained:
1) the catheter of the invention uses triclosan (TCS, triclosan, C)12H7C13Q2) The antibacterial coating is effectively fixed on the surface of the catheter inner tube body to form a bacteriostatic coating, has good dispersibility and is not easy to aggregate;
2) according to the catheter with the antibacterial coating, the plurality of shaping rings are horizontally arranged on the outer wall of the guide pipe in the transverse direction, so that the catheter has good elasticity and rigidity, the elasticity is gradually reduced along with the increase of the length of the guide pipe, the rigidity is gradually increased, the elliptical soft head is arranged on the upper portion of the guide pipe, the guide pipe is easy to turn, enough longitudinal thrust is provided, and the catheter is easy to enter a bent and blocked position. Through vertically be provided with many water conservancy diversion lines on the inner wall of stand pipe perpendicularly, can also play antibacterial effect through attaching to antibacterial material on the water conservancy diversion line when the drainage.
[ detailed description ] embodiments
In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
Fig. 1 is a schematic view showing the composition of a catheter with a bacteriostatic coating according to the invention, which consists of a guide part and a handheld part. Wherein, 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 component, 6 is an air bag, 7 is a sealing and fixing component, 8 is a water conduit, and 9 is a catheter inner tube body.
The guide part comprises a guide pipe and an elliptical soft head part, an opening is formed in the middle of the top of the elliptical soft head part, the upper part of the guide pipe is connected with the elliptical soft head part, the lower end of the guide pipe is connected with the handheld part, and the diameter of the guide pipe increases progressively along the extending direction from the upper end to the lower end; a plurality of flow guide lines are vertically arranged on the inner wall of the guide pipe in the longitudinal direction, and a plurality of plastic rings are horizontally arranged on the outer wall of the guide pipe in the transverse direction;
the handheld part comprises an inverted trapezoidal limiting part, a plug socket is arranged on the inverted trapezoidal limiting part and is in butt joint with the guide pipe, a urethral catheterization inner pipe body is arranged in the middle of the inverted trapezoidal limiting part, and the urethral inner pipe body is communicated with the guide pipe through the plug socket; the handheld part also comprises two air bags and two water guide pipes, the air bags are respectively fixed on two sides of the handheld part, the two water guide pipes are positioned on the inner side of the handheld part and are respectively positioned on two sides of the inner catheter body, one end of each water guide pipe is communicated with the air bags, and the other end of each water guide pipe is arranged in parallel with the inner catheter body;
the urine catheter is characterized in that a sealing and fixing part is arranged at an outlet at the lower side of the handheld part, three through holes are formed in the sealing and fixing part, and the inner catheter body and the two aqueducts penetrate through the through holes.
According to the catheter with the antibacterial coating, the plurality of shaping rings are horizontally arranged on the outer wall of the guide pipe in the transverse direction, so that the catheter has good elasticity and rigidity, the elasticity is gradually reduced along with the increase of the length of the guide pipe, the rigidity is gradually increased, the elliptical soft head is arranged on the upper portion of the guide pipe, the guide pipe is easy to turn, enough longitudinal thrust is provided, and the catheter is easy to enter a bent and blocked position. Through vertically be provided with many water conservancy diversion lines on the inner wall of stand pipe perpendicularly, can also play antibacterial effect through attaching to antibacterial material on the water conservancy diversion line when the drainage.
Fig. 2 is a schematic flow chart of the preparation process of the bacteriostatic coating. A layer of bacteriostatic drug can be loaded on the catheter by adopting a simple surface adsorption mode, but most of the drug is explosively released at the initial stage of contact with body fluid, the initial concentration is overlarge, the sustained release performance is poor, and the antibacterial drug not only has the advantages of high antibacterial activity, high antibacterial activity and low toxicityIs not beneficial to the recovery of patients and the persistence of the bacteriostasis. The invention relates to triclosan (TCS, triclosan, C) with bacteriostatic action12H7C13Q2) Effectively fixed on the surface of the catheter inner tube and the surface of the diversion line to form the bacteriostatic coating. TCS is used as a raw material required by preparation of the antibacterial coating, and the purity is 97%; the purity of the dopamine hydrochloride is 98 percent, the absolute methanol and the TRIS are analytically pure, and the guide line is polyglycolic acid (PGA).
Firstly, measuring 150mL of deionized water, adding 182.1mg of TRIS (hydroxymethyl) aminomethane (TRIS) into an aqueous solution to adjust the pH value of the solution to be alkalescent, and adding dopamine hydrochloride according to a set proportion after the TRIS is stirred and dissolved to form a PDA solution; then dissolving a proper amount of TCS in ethanol to form TCS ethanol solution; the two solutions were mixed to form a mixed solution, sealed and left with air holes, and stirred continuously. And after 24 hours, cutting the diversion line to a proper length, putting the diversion line into the mixed solution, and standing the solution in an oven at 37 ℃ for 24 hours. And taking out, washing with deionized water, and drying to obtain the flow guide line with the PDA-TCS coating. The surface appearance of the diversion line is observed by adopting a scanning electron microscope, and an electron energy spectrometer is utilized to analyze the change of the surface components.
The flow guide line with the PDA-TCS coating is precisely weighed and then placed into 20mL mixed Phosphate Buffer Solution (PBS) and placed into an oven at 37 ℃. And taking out the corresponding diversion lines after soaking for 4 hours, 8 hours, 1 day and 2 days respectively, washing with deionized water to remove residual PBS buffer solution on the surface, and then putting into an oven for drying. And then, extracting residual TCS on the surface of the diversion line by using methanol solution for ultrasonic treatment for 50 minutes, measuring the absorbance of the extracted TCS by using an ultraviolet-visible absorption spectrum, calculating the content of TCS according to a standard curve, and converting the content of TCS into the residual TCS on the surface of the diversion line after soaking. The standard curve is drawn by using the absorption peak intensity of TCS methanol solution with known concentration at about 280nm in the ultraviolet-visible absorption spectrum.
The release of TCS is related to the content of TCS loaded by the coating, and the coating with higher content of TCS releases TCS with the loading of more than 60 percent at the initial stage of soaking. Whereas coatings with a relatively low TCS content release only about 40%. But the relative amount of TCS released by the coating tends to be consistent as the soak time is extended. The reason for this is probably that the first stage is the release of TCS close to the surface layer of the PDA coating, and then over time, the TCS adsorbed on the PDA due to the bonding effect is released with the progressive degradation of the PDA, and this process proceeds more slowly. This release behavior shows that some of the TCS bound to PDA can be present more stably in the coating, and the coating degrades more slowly, which is beneficial for long-lasting antimicrobial action on the flow lines.
And (3) evaluating the antibacterial effect of the surface PDA-TCS coating by adopting an in-vitro antibacterial experiment. Firstly dipping 1.5 × 106 bacteria liquid by using a sterile cotton swab, uniformly coating the whole surface of an agar culture medium by using the cotton swab, repeating for 3 times, rotating the plate for 60 degrees each time, finally rotating for 2 circles along the periphery, putting the sterilized diversion line on the solid culture medium plate by using a sterile forceps after the moisture on the surface is completely absorbed by the agar, wherein the distance between every two samples is not less than 24mm, the distance between the centers of the samples is not less than 15mm, and the diversion line is completely pasted within 15 minutes after the bacteria inoculation. Then placing the mixture in an incubator at 37 ℃ for culturing for 1 day, 3 days and 7 days respectively, and observing the range of the inhibition zone to evaluate the antibacterial performance of the flow guide line with the coating.
The cotton swab evenly smears the golden yellow staphylococcus colony on the whole agar culture medium, and after a section of flow guide line with a PDA-TCS coating is placed, the colony is evenly filled in the whole culture medium at the beginning, but the colony around the flow guide line disappears after 3 days along with the prolonging of the culture time. This indicates that the prepared coating has a certain antibacterial effect. Moreover, with the increase of the loading amount of the TCS, the area of the bacteriostatic area around the diversion line is increased, which shows the improvement of the antibacterial performance. The coating has killing effect on different kinds of bacteria.
In order to further verify the clinical effect of the catheter with the bacteriostatic coating, the test data of patients using the catheter of the invention and the common rubber catheter on the 3 rd day and the 5 th day are compared and analyzed, the difference of the urinary infection incidence rate of the patients using the common rubber catheter has no significance (P is 0.149 and 0.054 respectively), but the difference of the urinary infection incidence rate of the patients on the 10 th day has significance (P is 0.031), the incidence rate of the catheter group with the bacteriostatic coating is lower, namely, the incidence rate of the later urinary infection of the patients who use the catheter with the bacteriostatic coating to perform indwelling catheterization is lower than that of the patients who use the common rubber catheter to perform indwelling catheterization.
On the basis of the detection, the corresponding detection is carried out on the patients with combined urethral injury, the same detection mode as the previous detection mode is adopted, the difference of the urinary infection incidence rate of the patients with the novel catheter and the common rubber catheter selected by the indwelling catheterization has no significance (P is more than 0.05) on the 3 rd day, the 5 th day and the 10 th day, but the urinary infection incidence rate of the patients with the indwelling catheterization selected by the common rubber catheter is still higher.
From the data, the catheter with the antibacterial coating has a good antibacterial effect, the problem that the patient who fails in catheterization for the first time conducts catheterization again can be solved to a certain extent, and the detection result shows that the incidence rate of urinary infection is obviously lower when the patient using the catheter with the antibacterial coating stays in catheterization for 10 days than when the patient uses a common rubber catheter.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, and not to limit the same; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions in the embodiments of the present application.