A urinary catheter and a method of making the same

Abstract

The present application relates to the technical field of urinary catheter, in particular to a urinary catheter and a preparation method thereof.The urinary catheter provided by the present application comprises an antibacterial catheter and an antibacterial coating on the wall of the antibacterial catheter, the antibacterial catheter is formed by an antibacterial base material of a surface modified inorganic antibacterial material, an organic antibacterial agent and a first high molecular polymer, and a second high molecular polymer is obtained by melt extrusion, the inorganic antibacterial material comprises an inorganic antibacterial agent and an organic dispersant, and the antibacterial coating comprises dopamine, a hydrophilic polymer and an antibacterial agent.The present application utilizes the antibacterial agent and the hydrophilic polymer to form a complex, which is dispersed in dopamine monomers, thereby reducing the possibility of fouling on the surface of the urinary catheter.Meanwhile, the inorganic antibacterial agent and the dispersant are formed into inorganic antibacterial material, thereby avoiding the reduction of the antibacterial performance caused by the precipitation of the antibacterial material due to the erosion of urine or other liquids, and the shortening of the service life of the urinary catheter.

Description

Technical Field

[0001] This invention relates to the field of urinary catheter technology, and more specifically to a urinary catheter and its preparation method. Background Technology

[0002] A urinary catheter is a tube inserted into the bladder through the urethra to drain urine. It is made of natural rubber, silicone rubber, or polyvinyl chloride (PVC) and is commonly used for urinary system diseases and postoperative treatments. However, the insertion of a urinary catheter, especially with long-term indwelling in the urinary system, often leads to bacterial colonization on the catheter wall, eventually forming a biofilm. This biofilm exhibits strong drug resistance, increasing the difficulty of treatment and causing secondary harm to the patient. Furthermore, urine components may precipitate on the catheter wall, causing scaling. This scaling further promotes bacterial colonization and makes the catheter prone to adhesion to urinary system tissues, making catheter removal difficult.

[0003] To prevent bacterial colonization and scaling on the walls of urinary catheters, antibacterial coatings have been developed to reduce the risk of urinary tract infections. Most existing coatings are drug-loaded or functional coatings, which reduce the bacterial colonization rate of the catheter by adding antibacterial or lubricating materials. However, coated catheters have biotoxicity issues during long-term use, resulting in short catheter indwelling time and short service life. This not only leads to high medical costs but also causes unnecessary suffering and infection risks for patients. Summary of the Invention

[0004] Therefore, the technical problem to be solved by the present invention is to overcome the biotoxicity problem of coated catheters in the prior art during long-term use, which leads to short catheter indwelling time and short service cycle, thereby providing a urinary catheter and its preparation method.

[0005] Therefore, the present invention provides a urinary catheter, including an antibacterial catheter and an antibacterial coating on the wall of the antibacterial catheter. The antibacterial catheter is obtained by melt extrusion of an antibacterial substrate formed by a surface-modified inorganic antibacterial material, an organic antibacterial agent and a first polymer and a second polymer. The inorganic antibacterial material includes an inorganic antibacterial agent and an organic dispersant. The antibacterial coating includes dopamine, a hydrophilic polymer and a coating antibacterial agent.

[0006] In some embodiments, the antibacterial coating further includes an oxidizing agent. Preferably, the oxidizing agent includes perhalate, hydrogen peroxide, copper sulfate, ammonium persulfate, and potassium chlorate; wherein the perhalate includes at least one of sodium perchlorate, potassium perchlorate, and sodium periodate; more preferably, the oxidizing agent includes at least one of sodium perchlorate or copper sulfate.

[0007] In some embodiments, the antibacterial coating further includes a reducing agent. Preferably, the reducing agent includes ascorbic acid, glucose, sodium citrate, sodium borohydride, and hydrazine hydrate; more preferably, the reducing agent includes at least one of ascorbic acid or glucose.

[0008] In some embodiments, the inorganic antibacterial agent comprises a first inorganic metal-loaded antibacterial agent and a metal elemental antibacterial agent. Preferably, the first inorganic metal-loaded antibacterial agent comprises at least one of zeolite-loaded metal antibacterial agents, phosphate-loaded metal antibacterial agents, glass-loaded metal antibacterial agents, and activated carbon fiber-loaded metal antibacterial agents. Preferably, the metal elemental antibacterial agent comprises at least one of nano-silver, nano-copper, or nano-zinc.

[0009] In some embodiments, the organic dispersant comprises at least one selected from oxidized polyethylene wax, stearic acid compounds, vinyl bis-stearamide, alkylphenol polyoxyethylene ether, silane coupling agents, and phthalate coupling agents. Preferably, the stearic acid compound comprises at least one selected from stearic acid, zinc stearate, or calcium stearate. More preferably, the organic dispersant comprises oxidized polyethylene wax.

[0010] In some embodiments, the organic antimicrobial agent includes at least one of N-n-octyl-4-isothiazolin-3-one, 4,5-dichloro-2-n-octyl-4-isothiazolin-3-one, and chitosan-based antimicrobial agents.

[0011] In some embodiments, the first polymer and / or the second polymer includes at least one of polyvinyl chloride, polyurethane, silicone, polytetrafluoroethylene, nitrile rubber, polybutadiene, and polyisoprene.

[0012] In some embodiments, the hydrophilic polymer includes at least one of polyethers, polyacrylates, polyacrylamides, and polyvinylpyrrolidones. Preferably, the hydrophilic polymer includes at least one of polyethylene oxide, polyacrylamide, or polyhydroxybutyl methacrylate.

[0013] In some embodiments, the polyether includes at least one of polyethylene oxide, polyethylene glycol, and polyethylene glycol mono(methacrylate).

[0014] In some embodiments, the polyacrylates include at least one of polyacrylic acid or polyhydroxyethyl (meth)acrylate.

[0015] In some embodiments, the polyacrylamide class includes at least one of polyacrylamide, polyN,N-dimethylacrylamide, polyN,N-diethylacrylamide, polyN-(2-hydroxyethyl)acrylamide, polyN-isopropylacrylamide, and polyacryloylmorpholine.

[0016] In some embodiments, polyvinylpyrrolidones include at least one of polyvinylpyrrolidone, poly(1-methyl-3-methylene-2-pyrrolidone), poly(1-ethyl-3-methylene-2-pyrrolidone), poly(1-methyl-5-methylene-2-pyrrolidone), poly(1-ethyl-5-methylene-2-pyrrolidone), poly(5-methyl-3-methylene-2-pyrrolidone), and poly(5-ethyl-3-methylene-2-pyrrolidone).

[0017] In some embodiments, the number-average molecular weight of the hydrophilic polymer is 250,000-3,500,000 Da. Preferably, the number-average molecular weight of the hydrophilic polymer is 300,000-3,000,000 Da.

[0018] In some embodiments, the coating antibacterial agent includes at least one of the following: ammonium-containing organic compounds, strontium-containing organic compounds, phosphonium-containing organic compounds, guanidine-containing organic compounds, biguanide-containing organic compounds, chitosan compounds, isothiazolinone compounds, inorganic salts, nanomaterial antibacterial agents, and second inorganic metal-based antibacterial agents. Preferably, the coating antibacterial agent includes at least one of chitosan compounds, ammonium-containing organic compounds, and isothiazolinone compounds.

[0019] In some embodiments, the chitosan compound includes at least one selected from quaternary phosphonium salt chitosan, quaternary ammonium salt chitosan, carboxymethyl chitosan, aminophosphate chitosan, p-chlorophenoxyacetyl modified chitosan, water-soluble catechol-functionalized chitosan, and polyethylene glycol grafted modified chitosan. The isothiazolinone compound includes at least one selected from 5-chloro-2-methyl-4-isothiazolin-3-one, 2-methyl-4-isothiazolin-3-one, 1,2-benzisothiazolin-3-one, n-butyl-1,2-benzisothiazolin-3-one, 2-n-octyl-4-isothiazolin-3-one, and 4,5-dichloro-2-n-octyl-3-isothiazolin-3-one; preferably, 2-n-octyl-4-isothiazolin-3-one and 4,5-dichloro-2-n-octyl-3-isothiazolin-3-one. The ammonium-containing organic compound includes at least one of polylysine, polyquaternary ammonium salt, and polyhexamethylene biguanide hydrochloride. The inorganic salt includes at least one of silver nitrate, copper nitrate, zinc nitrate, copper chloride, and zinc chloride. The nanomaterial antibacterial agent includes at least one of nano-silver or nano-cuprous oxide.

[0020] In some embodiments, the first inorganic metal-loaded antibacterial agent and / or the second inorganic metal-loaded antibacterial agent include at least one of silver-loaded zirconium phosphate, silver-loaded zinc zirconium phosphate, silver-loaded zinc zeolite, silver-loaded copper-zinc zeolite, silver-loaded zinc glass, silver-loaded silica, and silver-loaded layered silicate.

[0021] In some embodiments, the mass ratio of inorganic antibacterial agent to organic dispersant in the inorganic antibacterial material is 0.1-5:0.001-0.01. Preferably, the mass ratio of inorganic antibacterial agent to organic dispersant in the inorganic antibacterial material is 0.1-4:0.001-0.01.

[0022] In some embodiments, the mass ratio of inorganic antibacterial material, organic antibacterial agent, and first polymer in the antibacterial substrate is 0.10-20.0:0.010-10.0:70-99. In other embodiments, the mass ratio of inorganic antibacterial material, organic antibacterial agent, and first polymer in the antibacterial substrate is 5.0-15:3.0-8.0:77-92.

[0023] In some embodiments, the mass ratio of the antimicrobial substrate to the second polymer in the antimicrobial conduit is 2-15:85-98. Preferably, the mass ratio of the antimicrobial substrate to the second polymer in the antimicrobial conduit is 4-10:90-96.

[0024] In some embodiments, the mass ratio of dopamine, hydrophilic polymer, and antibacterial agent in the antibacterial coating is 8-90:5-90:0.001-10. Preferably, the mass ratio of dopamine, hydrophilic polymer, and antibacterial agent in the antibacterial coating is 20-80:10-80:0.1-10.

[0025] In some embodiments, the concentration of the oxidant in the coating forming the antibacterial coating is 0.50 mg / mL to 2.5 mg / mL. Preferably, the concentration of the oxidant in the coating forming the antibacterial coating is 0.50 mg / mL to 2 mg / mL.

[0026] In some embodiments, the concentration of the reducing agent in the coating forming the antibacterial coating is 6.0 mg / mL to 12 mg / mL. Preferably, the concentration of the reducing agent in the coating forming the antibacterial coating is 6.0 mg / mL to 10 mg / mL.

[0027] On the other hand, the present invention provides a method for preparing a urinary catheter, comprising the following steps: S1, mixing an inorganic antibacterial agent and a dispersant to obtain an inorganic antibacterial material, and mixing the inorganic antibacterial material, an organic antibacterial agent, and a first polymer to form an antibacterial substrate; S2, blending, melting, and extruding the antibacterial substrate and a second polymer to obtain an antibacterial catheter; S3, mixing a dopamine solution, a hydrophilic polymer, and an antibacterial agent to form an antibacterial coating; S4, immersing the antibacterial catheter in the antibacterial coating, removing it, and curing it to form a urinary catheter.

[0028] In some embodiments, the steps of immersing the antimicrobial conduit in the antimicrobial coating, removing it, and curing it are repeated at least twice. Preferably, the steps of immersing the antimicrobial conduit in the antimicrobial coating, removing it, and curing it are repeated 2-4 times.

[0029] In some embodiments, the steps of immersing the antibacterial conduit in the antibacterial coating, removing it, and curing it specifically involve immersing the antibacterial conduit in the antibacterial coating at a temperature of 18-35°C for 15 seconds to 2 minutes, and drying the antibacterial conduit removed from the antibacterial coating for 12-36 hours, preferably 18-24 hours.

[0030] The technical solution of this invention has the following advantages:

[0031] 1. The present invention provides a urinary catheter, comprising an antibacterial catheter and an antibacterial coating on the wall of the antibacterial catheter. The antibacterial catheter is obtained by melt extrusion of an antibacterial substrate formed by a surface-modified inorganic antibacterial material, an organic antibacterial agent and a first polymer, and a second polymer. The inorganic antibacterial material includes an inorganic antibacterial agent and an organic dispersant. The antibacterial coating includes dopamine, a hydrophilic polymer and an antibacterial agent. This invention utilizes an antibacterial agent combined with a hydrophilic polymer to form a complex. The stable, solidified complex is dispersed in dopamine monomers. As dopamine polymerizes and solidifies, the complex is uniformly dispersed on the antibacterial coating impregnated on the wall of the antibacterial catheter. When the urinary catheter comes into contact with urine or other solutions, the polydopamine firmly binds to the antibacterial catheter, and the stabilized, solidified complex exerts an antibacterial and bactericidal effect, preventing bacterial adhesion, proliferation on the catheter wall, and biofilm formation. Simultaneously, the hydrophilic polymer in the complex forms a surface hydrogel-like polymeric aggregate soft substance that is not easily adhered to by bacteria, hindering bacterial colonization and reproduction on the surface, thus preventing bacterial infection and scale formation caused by bacteria and urine exudates on the surface of the urinary catheter. Furthermore, the hydrophilic polymer also has good lubricity, further reducing the possibility of scale formation on the surface of the urinary catheter.

[0032] Meanwhile, this invention utilizes a compound of inorganic antibacterial materials and organic antibacterial agents, and forms a catheter with antibacterial properties by blending it with a polymer. By forming an inorganic antibacterial material from inorganic antibacterial agents and dispersants, on the one hand, the surface of the inorganic antibacterial agent is modified by the organic dispersant, promoting the dispersion of the inorganic antibacterial agent in the system formed by the first polymer and organic antibacterial agent. On the other hand, the organic dispersant and organic antibacterial agent form a slow-release channel for migration to the surface. Taking advantage of the smaller molecular weight and larger free space of the organic dispersant and organic antibacterial agent compared to the polymer, they can act as a molecular movement channel to continuously deliver and release the inorganic and organic antibacterial agents to the surface of the catheter. This avoids the reduction of antibacterial performance caused by the antibacterial material precipitation due to rinsing by urine or other liquids over a long period of use, thus shortening the service life of the urinary catheter.

[0033] 2. The present invention provides a urinary catheter, wherein the antibacterial coating further includes an oxidizing agent. By adding an oxidizing agent to the antibacterial coating, the present invention can improve the polymerization efficiency of dopamine and shorten the coating time on the surface of the antibacterial urinary catheter.

[0034] 3. This invention provides a method for preparing a urinary catheter, comprising the following steps: S1, mixing an inorganic antibacterial agent and a dispersant to obtain an inorganic antibacterial material; mixing the inorganic antibacterial material, an organic antibacterial agent, and a first polymer to form an antibacterial substrate; S2, blending, melting, and extruding the antibacterial substrate and a second polymer to obtain an antibacterial catheter; S3, mixing a dopamine solution, a hydrophilic polymer, and an antibacterial agent to form an antibacterial coating; S4, immersing the antibacterial catheter in the antibacterial coating, removing it, and curing it to form a urinary catheter. This invention, by forming an antibacterial substrate from inorganic antibacterial materials, an organic antibacterial agent, and a first polymer, then using it to form an antibacterial catheter with a second polymer, and finally immersing the antibacterial catheter in an antibacterial coating to form a urinary catheter with an antibacterial coating, provides a simple preparation method, and the resulting urinary catheter exhibits good biocompatibility and long-lasting antibacterial activity. Attached Figure Description

[0035] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0036] Figure 1 This is a schematic diagram of the urinary catheter structure obtained in Embodiment 1 of the present invention. Detailed Implementation

[0037] The following embodiments are provided to better understand the present invention and are not limited to the preferred embodiments described. They do not constitute a limitation on the content and scope of protection of the present invention. Any product that is the same as or similar to the present invention, derived by any person under the guidance of the present invention or by combining the features of the present invention with other prior art, falls within the protection scope of the present invention.

[0038] For experiments not specifically described in the examples, the procedures or conditions should be followed according to the conventional experimental procedures described in the literature in this field. Reagents or instruments whose manufacturers are not specified are all commercially available conventional reagent products.

[0039] Example 1

[0040] This embodiment provides a method for preparing a urinary catheter, the specific steps and parameters of which are as follows:

[0041] (1) Take the dried silver-zinc glass antibacterial agent (Million Guard PG-721) ST 0.5 kg of oxidized polyethylene wax (Qingdao Bonnie New Material Co., Ltd.) and 0.01 kg of oxidized polyethylene wax were mixed in a high-speed mixer at 1500 rpm for 2 minutes to obtain a surface-modified silver-zinc glass antibacterial agent.

[0042] Take 9.2 kg of thermoplastic polyurethane granules (Pellethane 2363-80AE, lubrizol, USA), dehydrate and dry (drying temperature 82-93°C, time 3h), mix with 0.5 kg of surface-modified silver-zinc glass antibacterial agent and 0.3 kg of N-n-octyl-4-isothiazolin-3-one (OIT, Weifang Yukai Chemical Co., Ltd.), and stir at 750 rpm for 2 min in a high-speed mixer to obtain a mixture;

[0043] The mixture is melt-extruded and granulated at the set temperature of the screw barrel using a twin-screw extruder (ZSK 32 Mc18 type, Coperon (Nanjing) Machinery Co., Ltd., with a screw barrel temperature range of 188-204℃ and a screw speed of 450rpm) to obtain cylindrical antibacterial masterbatch granules with a particle size of 2-3mm.

[0044] (2) Take 9.0 kg of thermoplastic polyurethane granules (Pellethane 2363-80AE, lubrizol, USA) and 1.0 kg of antibacterial masterbatch obtained in step (1), mix them, and extrude the tube in a medical tube extruder (model HP-YLG, Guangdong Huapu Plastic Machinery Co., Ltd.), cut it, and obtain antibacterial tubes with a diameter of 4 mm and a length of 20 cm.

[0045] Under ultrasonic (60kHz) treatment, the obtained antibacterial tubing was sequentially cleaned with anhydrous ethanol and deionized water for 30 minutes each, and then dried with clean air to obtain clean antibacterial tubing.

[0046] (3) Dopamine hydrochloride (Tianjin Xins Biochemical Technology Co., Ltd.) was dissolved in Tris-HCl buffer (pH 8.5, 50mM) to obtain a dopamine solution with a concentration of 6 mg / mL;

[0047] Polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) was dissolved in deionized water, and then AgNO3 solution was added to obtain a mixture of 40 mg / mL PEO and 0.50 mg / mL AgNO3, i.e., PEO / AgNO3 solution.

[0048] Dopamine solution and PEO / AgNO3 solution were mixed evenly at a volume ratio of 1:1 to obtain a catheter coating composition solution.

[0049] The cleaned antibacterial tubing from step (2) is immersed in the catheter coating composition solution at 25°C for 1 minute and then pulled out. It is then dried and cured at 25°C for 24 hours in a clean room to obtain a urinary catheter with antibacterial and anti-scaling properties.

[0050] A schematic diagram of the urinary catheter structure obtained in this embodiment can be found in [reference needed]. Figure 1 The urinary catheter includes an antibacterial catheter 1 and an antibacterial coating 2 on the wall of the antibacterial catheter.

[0051] Example 2

[0052] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that the concentration of PEO in the PEO / AgNO3 solution in step (3) is 20 mg / mL.

[0053] Example 3

[0054] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Embodiment 1. The difference is that an equal mass of Andime CAG nano-silver powder (Beijing Chonggao Nanotechnology Co., Ltd.) is used to replace the silver-zinc glass antibacterial agent in step (1).

[0055] Example 4

[0056] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Embodiment 1. The difference is that an equal mass of silver-loaded zirconium phosphate (6% silver loading, Xiamen Jinda Nanotechnology Co., Ltd.) is used to replace the silver-zinc glass antibacterial agent in step (1).

[0057] Example 5

[0058] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of the antibacterial agent 4,5-dichloro-2-n-octyl-4-isothiazolin-3-one (DCOIT) is used to replace N-n-octyl-4-isothiazolin-3-one in step (1).

[0059] Example 6

[0060] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1, except that the concentration of dopamine solution in step (3) is 36 mg / mL.

[0061] Example 7

[0062] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Embodiment 1. The difference is that zinc stearate of equal mass is used to replace the oxidized polyethylene wax in step (1).

[0063] Example 8

[0064] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of isopropyltris(dioctylpyrophosphate)titanate (purchased from Shanghai McLean Biochemical Technology Co., Ltd.) is used to replace the oxidized polyethylene wax in step (1).

[0065] Example 9

[0066] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the PEO / AgNO3 solution also includes 6.0 mg / mL of ascorbic acid. More specifically, the preparation process of the PEO / AgNO3 solution is as follows: polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) is dissolved in deionized water, AgNO3 solution is added, and then ascorbic acid is added to obtain a mixture of 40 mg / mL PEO, 0.50 mg / mL AgNO3, and 1.0 mg / mL ascorbic acid, i.e., the PEO / AgNO3 solution.

[0067] Example 10

[0068] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the PEO / AgNO3 solution also includes 6.0 mg / mL glucose. More specifically, the preparation process of the PEO / AgNO3 solution is as follows: polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) is dissolved in deionized water, AgNO3 solution is added, and then glucose is added to obtain a mixture of 40 mg / mL PEO, 0.50 mg / mL AgNO3, and 1.0 mg / mL glucose, which is the PEO / AgNO3 solution.

[0069] Example 11

[0070] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that in step (3), the PEO / AgNO3 solution also includes 6.0 mg / mL sodium borohydride. More specifically, the preparation process of the PEO / AgNO3 solution is as follows: polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) is dissolved in deionized water, AgNO3 solution is added, and then polyvinylpyrrolidone is added to obtain a mixture of 40 mg / mL PEO, 0.50 mg / mL AgNO3, and 1.0 mg / mL polyvinylpyrrolidone, i.e., the PEO / AgNO3 solution.

[0071] Example 12

[0072] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the PEO / AgNO3 solution also includes 6.0 mg / mL sodium citrate. More specifically, the preparation process of the PEO / AgNO3 solution is as follows: polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) is dissolved in deionized water, AgNO3 solution is added, and then sodium citrate is added to obtain a mixture of 40 mg / mL PEO, 0.50 mg / mL AgNO3, and 6.0 mg / mL sodium citrate, which is the PEO / AgNO3 solution.

[0073] Example 13

[0074] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the PEO / AgNO3 solution also includes 2 mg / mL of ammonium persulfate. More specifically, the preparation process of the PEO / AgNO3 solution is as follows: polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) is dissolved in deionized water, AgNO3 solution is added, and then ammonium persulfate is added to obtain a mixture of 40 mg / mL PEO, 0.5 mg / mL AgNO3, and 2 mg / mL ammonium persulfate, i.e., PEO / AgNO3 solution.

[0075] The cleaned antibacterial tubing from step (2) is immersed in the catheter coating composition solution at 25°C for 45 seconds and then pulled out. It is then dried and cured at 25°C for 24 hours in a clean room to obtain a urinary catheter with antibacterial and anti-scaling properties.

[0076] The remaining steps are the same as in Example 1.

[0077] Example 14

[0078] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Embodiment 1. The difference is that in step (3), the PEO / AgNO3 solution also includes 2 mg / mL of copper sulfate. More specifically, the preparation process of the PEO / AgNO3 solution is as follows: polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) is dissolved in deionized water, AgNO3 solution is added, and then copper sulfate is added to obtain a mixture of 40 mg / mL PEO, 0.50 mg / mL AgNO3, and 2 mg / mL CuSO4, i.e., the PEO / AgNO3 solution.

[0079] The cleaned antibacterial tubing from step (2) is immersed in the catheter coating composition solution at 25°C for 20 seconds and then lifted out. It is then dried and cured at 25°C for 24 hours in a clean room to obtain a urinary catheter with antibacterial and anti-scaling properties.

[0080] The remaining steps are the same as in Example 1.

[0081] Example 15

[0082] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the PEO / AgNO3 solution also includes 2 mg / mL NaClO4. More specifically, the preparation process of the PEO / AgNO3 solution is as follows: dissolve polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) in deionized water, add AgNO3 solution, and then add NaClO4 to obtain a mixture of 40 mg / mL PEO, 0.50 mg / mL AgNO3, and 12 mg / mL NaClO4, which is the PEO / AgNO3 solution.

[0083] The cleaned antibacterial tubing from step (2) is immersed in the catheter coating composition solution at 25°C for 15 seconds and then pulled out. It is then dried and cured at 25°C for 24 hours in a clean room to obtain a urinary catheter with antibacterial and anti-scaling properties.

[0084] The remaining steps are the same as in Example 1.

[0085] Example 16

[0086] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that quaternary ammonium chitosan (hydroxypropyltrimethylammonium chloride chitosan, Qingdao Bozhi Huili Biotechnology Co., Ltd.) is used to replace silver nitrate in step (3) to obtain a PEO / quaternary ammonium chitosan solution. The concentration of quaternary ammonium chitosan in the PEO / quaternary ammonium chitosan solution is 0.01 mg / mL.

[0087] Example 17

[0088] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of 2-n-octyl-4-isothiazolin-3-one is used to replace silver nitrate in step (3).

[0089] Example 18

[0090] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of polyquaternium-1 (policochloride, Shandong Shenlian Pharmaceutical Co., Ltd.) is used to replace silver nitrate in step (3).

[0091] Example 19

[0092] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of polyacrylamide (PAM, Wn 3,500,000, Sigma-Aldrich, USA) is used to replace the polyoxyethylene in step (3).

[0093] Example 20

[0094] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of polyhydroxybutyl methacrylate (Mn320000) is used to replace the polyethylene oxide in step (3).

[0095] Example 21

[0096] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of polyvinylpyrrolidone (PVP K90, Hefei Tianjian Chemical Co., Ltd.) is used to replace the polyethylene oxide in step (3).

[0097] Example 22

[0098] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1, except that an equal mass of polyacrylamide (Mn 380000) is used to replace the polyethylene oxide in step (3).

[0099] Example 23

[0100] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the antibacterial tubing cleaned in step (2) is immersed in the catheter coating composition solution at 25°C and left for 1 minute. The lifting step is repeated twice.

[0101] Example 24

[0102] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the antibacterial tubing cleaned in step (2) is immersed in the catheter coating composition solution at 25°C and left for 1 minute. The lifting step is repeated 3 times.

[0103] Example 25

[0104] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the antibacterial tubing cleaned in step (2) is immersed in the catheter coating composition solution at 25°C and left for 1 minute. The lifting step is repeated 4 times.

[0105] Example 26

[0106] This embodiment provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in embodiment 1. The difference is that in step (3), the antibacterial tubing cleaned in step (2) is immersed in the catheter coating composition solution at 25°C and left for 1 minute. The lifting step is repeated 5 times.

[0107] Example 27

[0108] This embodiment provides a method for preparing a urinary catheter, the specific steps and parameters of which are as follows:

[0109] (1) Take the dried silver-zinc glass antibacterial agent (Million Guard PG-721) ST 0.1 kg of Nippon Koya Glass Co., Ltd. and 0.01 kg of oxidized polyethylene wax (Qingdao Bonnie New Material Co., Ltd.) were mixed in a high-speed mixer at 1500 rpm for 2 minutes to obtain a surface-modified silver-zinc glass antibacterial agent.

[0110] 7.7 kg of thermoplastic polyurethane granules (Pellethane 2363-80AE, lubrizol, USA) were dehydrated and dried (drying temperature 88℃, time 3h) and mixed with 1.5 kg of surface-modified silver-zinc glass antibacterial agent and 0.8 kg of N-n-octyl-4-isothiazolin-3-one (OIT, Weifang Yukai Chemical Co., Ltd.) in a high-speed mixer mixing vessel at 750 rpm for 2 min to obtain a mixture.

[0111] The mixture is melt-extruded and granulated at the set temperature of the screw barrel using a twin-screw extruder (ZSK 32 Mc18 type, Coperon (Nanjing) Machinery Co., Ltd., with a screw barrel temperature range of 188-204°C and a screw speed of 450 rpm) to obtain cylindrical antibacterial masterbatch granules with a particle size of 2-3 mm.

[0112] (2) Take 9.6 kg of thermoplastic polyurethane granules (Pellethane 2363-80AE, lubrizol, USA) and 0.4 kg of antibacterial masterbatch obtained in step (1), mix them, extrude the tube in a medical tube extruder (model HP-YLG), cut it, and obtain antibacterial tube. The diameter of the antibacterial tube is 4 mm and the length is 20 cm.

[0113] Under ultrasonic (60kHz) treatment, the obtained antibacterial tubing was sequentially cleaned with anhydrous ethanol and deionized water for 30 minutes each, and then dried with clean air to obtain clean antibacterial tubing.

[0114] (3) Dopamine hydrochloride (Tianjin Xins Biochemical Technology Co., Ltd.) was dissolved in Tris-HCl buffer (pH 8.5, 50mM) to obtain a dopamine solution with a concentration of 2 mg / mL;

[0115] Polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) was dissolved in deionized water, and then AgNO3 solution was added to obtain a mixture of 8 mg / mL PEO and 0.01 mg / mL AgNO3, i.e., PEO / AgNO3 solution.

[0116] Dopamine solution and PEO / AgNO3 solution were mixed evenly at a volume ratio of 1:1 to obtain a catheter coating composition solution.

[0117] The cleaned antibacterial tubing from step (2) was immersed in the catheter coating composition solution at 18°C ​​for 2 minutes and then pulled out. It was then dried and cured at 25°C for 12 hours in a clean room to obtain a urinary catheter with antibacterial and anti-scaling properties.

[0118] Example 28

[0119] This embodiment provides a method for preparing a urinary catheter, the specific steps and parameters of which are as follows:

[0120] (1) Take the dried silver-zinc glass antibacterial agent (Million Guard PG-721) ST 4 kg of oxidized polyethylene wax (Qingdao Bonnie New Material Co., Ltd.) and 0.001 kg of oxidized polyethylene wax were mixed in a high-speed mixer at 1500 rpm for 2 minutes to obtain a surface-modified silver-zinc glass antibacterial agent.

[0121] Take 9.2 kg of thermoplastic polyurethane granules (Pellethane 2363-80AE, lubrizol, USA), dehydrate and dry (drying temperature 88℃, time 3h), mix with 0.5 kg of surface-modified silver-zinc glass antibacterial agent and 0.3 kg of N-n-octyl-4-isothiazolin-3-one (OIT, Weifang Yukai Chemical Co., Ltd.), and stir at 750 rpm for 2 min in a high-speed mixer to obtain a mixture;

[0122] The mixture is melt-extruded and granulated at the set temperature of the screw barrel using a twin-screw extruder (ZSK 32 Mc18 type, Coperon (Nanjing) Machinery Co., Ltd., with a screw barrel temperature range of 188-204℃ and a screw speed of 450rpm) to obtain cylindrical antibacterial masterbatch granules with a particle size of 2-3mm.

[0123] (2) Take 9 kg of thermoplastic polyurethane granules (Pellethane 2363-80AE, lubrizol, USA) and 1 kg of antibacterial masterbatch prepared in step (1), mix them, extrude the tube in a medical tube extruder (model HP-YLG), cut it, and obtain antibacterial tube. The diameter of the antibacterial tube is 4 mm and the length is 20 cm.

[0124] Under ultrasonic (60kHz) treatment, the obtained antibacterial tubing was sequentially cleaned with anhydrous ethanol and deionized water for 30 minutes each, and then dried with clean air to obtain clean antibacterial tubing.

[0125] (3) Dopamine hydrochloride (Tianjin Xins Biochemical Technology Co., Ltd.) was dissolved in Tris-HCl buffer (pH 8.5, 50mM) to obtain a dopamine solution with a concentration of 8 mg / mL;

[0126] Polyethylene oxide (PEO, Wn 300,000, Sigma-Aldrich, USA) was dissolved in deionized water, and then AgNO3 solution and copper sulfate solution were added and mixed to obtain a mixture of 1 mg / mL PEO, 1 mg / mL AgNO3 and 0.50 mg / mL copper sulfate solution, namely PEO / AgNO3 solution.

[0127] Dopamine solution and PEO / AgNO3 solution were mixed evenly at a volume ratio of 1:1 to obtain a catheter coating composition solution.

[0128] The cleaned antibacterial tubing from step (2) was immersed in the catheter coating composition solution at 35°C for 45 seconds, then pulled out. This immersion and pulling process was repeated twice. The tubing was then dried and cured at 25°C for 36 hours in a clean room to obtain a urinary catheter with antibacterial and anti-scaling properties.

[0129] Comparative Example 1

[0130] This comparative example provides a method for preparing a urinary catheter, with the specific steps and parameters as follows:

[0131] Thermoplastic polyurethane granules (Pellethane 2363-80AE, lubrizol, USA) are extruded into tubing through a medical tubing extruder, and then cut to obtain antibacterial tubing. The antibacterial tubing has a diameter of 4 mm and a length of 20 cm.

[0132] The obtained antibacterial tubing was ultrasonically cleaned with anhydrous ethanol and deionized water for 30 minutes in sequence, and then dried with clean air to obtain clean antibacterial tubing.

[0133] Comparative Example 2

[0134] This comparative example provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1, except that step (3) is not included. That is, the clean antibacterial tubing obtained in step (2) is used as the urinary catheter.

[0135] Comparative Example 3

[0136] This comparative example provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that in step (3), 40 mg / mL PEO is used instead of PEO / AgNO3 solution, that is, the catheter coating composition solution does not contain AgNO3.

[0137] Comparative Example 4

[0138] This comparative example provides a method for preparing a urinary catheter. The specific steps and parameters are the same as those in Example 1. The difference is that step (1) is not included and step (2) does not contain antibacterial masterbatch. That is, the antibacterial tubing obtained in Comparative Example 1 is the antibacterial tubing of this comparative example. Step (3) is the same as that in Example 1.

[0139] Comparative Example 5

[0140] This comparative example provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of surface-modified silver-zinc glass antibacterial agent is used to replace N-n-octyl-4-isothiazolin-3-one in step (1). That is, the mixture in step (1) contains 0.8 kg of surface-modified silver-zinc glass antibacterial agent and does not contain N-n-octyl-4-isothiazolin-3-one.

[0141] Comparative Example 6

[0142] This comparative example provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1. The difference is that an equal mass of N-n-octyl-4-isothiazolin-3-one is used to replace the surface-modified silver-zinc glass antibacterial agent in step (1). That is, the mixture in step (1) contains 0.8 kg of N-n-octyl-4-isothiazolin-3-one and does not contain the surface-modified silver-zinc glass antibacterial agent.

[0143] Comparative Example 7

[0144] This comparative example provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1, except that step (1) does not contain a dispersant. Specifically, 9.2 kg of thermoplastic polyurethane particles (Pellethane 2363-80AE, Lubrizol, USA) are dehydrated and dried, and then mixed with 0.5 kg of silver-zinc glass antibacterial agent and 0.3 kg of N-octyl-4-isothiazolin-3-one (OIT, Weifang Yukai Chemical Co., Ltd.) in a high-speed mixer at 750 rpm for 2 minutes to obtain a mixture. The mixture is then melt-extruded and granulated using a twin-screw extruder to obtain an antibacterial masterbatch. The remaining steps are the same as in Example 1.

[0145] Comparative Example 8

[0146] This comparative example provides a method for preparing a urinary catheter. The specific steps and parameters are the same as in Example 1, except that an equal mass of sodium hexametaphosphate is used to replace the oxidized polyethylene wax in step (1).

[0147] Experimental Example

[0148] I. Durability Condition Test

[0149] Referring to the experimental conditions for the anti-fouling performance of biomimetic hydrophilic surfaces at room temperature in the literature (Chen Le. Design and performance of biomimetic antifouling interface materials based on non-specific adsorption barriers [D]. Hebei: Yanshan University, 2023.), the durability conditions of the urinary catheters formed in Examples 1-28 and Comparative Examples 1-2 of this invention were tested.

[0150] The specific steps are as follows: Add equal volumes of deionized water to two beakers, then add anhydrous CaCl2 and Na2CO3 powders respectively. Stir openly at room temperature for 30 min until completely dissolved, preparing 20 mM salt solutions. Slowly add CaCl2 solution to the Na2CO3 solution and stir openly at room temperature for 10 min to prepare a 10 mM supersaturated CaCO3 solution. Add the urinary catheter sample to a fluorosilane-modified glass beaker, placing it flat at the bottom. Slowly add the well-mixed saturated salt solution along the wall of the glass beaker. Immerse the sample in 500 mL of a mixed solution of 0.010 M CaCl2 and 0.010 M Na2CO3 at room temperature for 1 day, 5 days, 10 days, 20 days, 30 days, 40 days, and 60 days. Test the antibacterial properties, cytotoxicity, and anti-fouling effects of the samples after different immersion times.

[0151] II. Anti-fouling performance test

[0152] The samples obtained from different soaking times in step (I) of this experimental example were removed from the supersaturated salt solution and gently rinsed with deionized water to remove salt crystals and supersaturated salt solution adhering to the surface of the conduit. The conduit was dried in an electric drying oven at 40℃ for 6 h, and then dissolved in 0.2 M Na2-EDTA solution to obtain 10 mL of calcium salt solution. The EDTA calcium salt solution was then diluted with deionized water to 100 mL. The simulated scaling phenomenon of calcium salt on the conduit was quantitatively determined using inductively coupled plasma atomic emission spectrometry. The results are shown in Table 1.

[0153] Table 1 Anti-scaling properties of urinary catheter surfaces

[0154]

[0155] As shown in Table 1, compared to the urinary catheter made of ordinary TPU material in Comparative Example 1 and the urinary catheter made of antibacterial TPU material in Comparative Example 2, both of which have no surface coating and thus accumulate more scale, the urinary catheters provided in Examples 1-28 of this invention all have a hydrophilic coating on their surface, resulting in less scale accumulation. Furthermore, compared to Examples 21 and 22, which use polyvinylpyrrolidone or polyacrylamide, the hydrophilic polymers provided in Examples 1-20 and Examples 23-28 can significantly reduce the amount of scale buildup in the urinary catheters, and the scale buildup can be maintained at 0.48 mg / cm³ for 60 days. 2 Within.

[0156] III. Antibacterial performance testing:

[0157] The antibacterial properties of the urinary catheters prepared in Examples 1-28 and Comparative Examples 1-8 of this invention were determined in accordance with ISO 22196-2011 "Method for evaluating the antimicrobial properties of surfaces of plastic articles".

[0158] To test the long-lasting antibacterial properties of the urinary catheters prepared in each embodiment and comparative example, the test samples were immersed in the sample according to step (I) of this experimental example for 1 day, 5 days, 10 days, 20 days, 30 days, 40 days, and 60 days. The antibacterial properties of the urinary catheter surface after immersion for different numbers of days were measured, and the results are shown in Table 1. Among them, the antibacterial properties against Proteus mirabilis (… P. milabilis ) or Staphylococcus aureus ( S. aureus The antibacterial rate % was calculated as follows: (average number of bacteria per unit area of ​​untreated sample - average number of bacteria per unit area of ​​treated sample) / average number of bacteria per unit area of ​​untreated sample × 100%. The results are shown in Table 2.

[0159] Table 2 shows that, compared to Comparative Example 1, the urinary catheter made of ordinary TPU material has poor antibacterial performance; Comparative Example 2, the urinary catheter made of antibacterial TPU material has good antibacterial performance, but the antibacterial effect decreases rapidly with prolonged soaking time; Comparative Example 3, the urinary catheter made of antibacterial TPU material with a surface coating without antibacterial agent has poor antibacterial performance; Comparative Example 4, the antibacterial TPU catheter treated with a coating containing antibacterial agent, although showing good short-term antibacterial effect, does not have a long-term antibacterial effect; Comparative Example 5, the antibacterial TPU material... The PU catheter uses only inorganic antibacterial agents, which have a good initial antibacterial effect, but the subsequent antibacterial rate is low, although relatively stable. The antibacterial TPU catheter of Comparative Example 6 uses only organic antibacterial agents, which have a good initial antibacterial effect, but the effect decays quickly and the subsequent antibacterial rate is low. The inorganic antibacterial material of Comparative Example 7 does not contain dispersants, so the antibacterial agent in the catheter cannot be delivered to the coating, resulting in a significant decrease in antibacterial effect after 20 days of use of the urinary catheter. In contrast, the urinary catheters 1-30 provided in the embodiments of the present invention not only have good antibacterial effect, but also show good long-term antibacterial performance.

[0160] Table 2 Antibacterial properties of urinary catheter surfaces

[0161]

[0162] IV. Cytotoxicity Detection

[0163] The in vitro cytotoxicity of the urinary catheters prepared in Examples 1-28 and Comparative Examples 2 and 5-8 of this invention was tested at different treatment times in Experiment 1, according to the methods in GB / T 16886.5-2017 "Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test". The test results are shown in Table 3, where grades 0 and 1 meet the requirements for biomedical materials.

[0164] Table 3. In vitro cytotoxicity of urinary catheters

[0165]

[0166] According to the data in Table 3, Comparative Example 2, without a coating, had its organic and inorganic antibacterial agents in the antibacterial catheter directly exposed, resulting in a biotoxicity level of 2 for the urinary catheter. Comparative Examples 5 and 6, using only inorganic or organic antibacterial agents to form urinary catheters, also exhibited high biotoxicity, reaching level 2. Specifically, Comparative Example 5, using only a single inorganic antibacterial agent, showed significant cytotoxicity in the early stages of use. As the usage time increased, the toxicity decreased due to the buffering effect of the coating on the release of the antibacterial agent. Later, as the coating gradually decreased, the buffering effect of the coating on the antibacterial agent released from the catheter weakened, leading to increased cytotoxicity on the surface. Comparative Example 6, using an organic antibacterial agent as the raw material for the antibacterial catheter, had an uncontrollable release rate of the antibacterial material in the catheter, resulting in cytotoxicity. Comparative Example 7, lacking a dispersant in its inorganic antibacterial material, had poor dispersibility of the antibacterial agent within the catheter, leading to significant cytotoxicity. The catheter made from a masterbatch formed by combining an organic antibacterial agent and an inorganic antibacterial agent, and then coated with a hydrophilic antibacterial polydopamine coating, exhibits low cytotoxicity (grade 0 or 1). It does not cause cytotoxicity during use, indicating that the urinary catheter provided by this invention has good biocompatibility.

[0167] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A urinary catheter, characterized in that, The antibacterial catheter and the antibacterial coating on the wall of the antibacterial catheter, The antibacterial catheter is formed by melt extrusion of an antibacterial base material formed by an inorganic antibacterial material and a first high molecular polymer and a second high molecular polymer, the inorganic antibacterial material comprises an inorganic antibacterial agent and an organic dispersant, the organic dispersant comprises at least one of oxidized polyethylene wax, stearic acid compound, vinyl bis-stearamide, alkyl phenol polyoxyethylene ether, silane coupling agent, phthalate coupling agent; The antibacterial coating comprises dopamine, a hydrophilic polymer and a coating antibacterial agent; the hydrophilic polymer comprises at least one of polyether and polyacrylate.

2. The urinary catheter of claim 1, wherein, The antibacterial coating further comprises an oxidizing agent; and / or, The antibacterial coating further comprises a reducing agent; and / or, The inorganic antibacterial agent comprises a first inorganic metal-loaded antibacterial agent and a metal elemental antibacterial agent; and / or, The organic antibacterial agent comprises at least one of N-n-octyl-4-isothiazolin-3-ketone, 4,5-dichloro-2-n-octyl-4-isothiazolin-3-ketone and chitosan antibacterial agent.

3. The urinary catheter of claim 2, wherein, The oxidizing agent comprises at least one of high halide, hydrogen peroxide, copper sulfate, ammonium persulfate and potassium chlorate; and / or, The reducing agent comprises at least one of ascorbic acid, glucose, sodium citrate and sodium borohydride; and / or, The first inorganic metal-loaded antibacterial agent comprises at least one of zeolite metal-loaded antibacterial agent, phosphate metal-loaded antibacterial agent, glass metal-loaded antibacterial agent and activated carbon fiber metal-loaded antibacterial agent.

4. The urinary catheter of claim 3, wherein, The high halide comprises at least one of sodium perchlorate, potassium perchlorate and sodium periodate; and / or, The stearic acid compound comprises at least one of stearic acid, zinc stearate or calcium stearate; and / or, The metal elemental antibacterial agent comprises at least one of nano-silver, nano-copper or nano-zinc; and / or, The first high molecular polymer and / or the second high molecular polymer comprises at least one of polyvinyl chloride, polyurethane, silica gel, polytetrafluoroethylene, nitrile rubber, polybutadiene and polyisoprene.

5. The urinary catheter of claim 4, wherein, The oxidizing agent comprises at least one of sodium perchlorate or copper sulfate; and / or, The reducing agent comprises at least one of ascorbic acid or glucose; and / or, The organic dispersant comprises oxidized polyethylene wax; and / or, The polyether comprises at least one of polyoxyethylene, polyethylene glycol and polyethylene glycol mono(methacrylate); and / or, The polyacrylate comprises at least one of polyacrylic acid or polyhydroxybutyl (meth)acrylate; and / or, The number average molecular weight of the hydrophilic polymer is 250000-3500000 Da; and / or, The coating antibacterial agent comprises at least one of ammonium group-containing organic compound, phosphonium group-containing organic compound, phosphonium group-containing organic compound, guanidine group-containing organic compound, biguanide group-containing organic compound, chitosan compound, isothiazolinone compound, inorganic salt, nanomaterial antibacterial agent and second inorganic metal-loaded antibacterial agent.

6. The urinary catheter of claim 5, wherein, The hydrophilic polymer comprises at least one of polyoxyethylene or polyhydroxybutyl (meth)acrylate; and / or, The coating antibacterial agent comprises at least one of chitosan compounds, ammonium group-containing organic compounds, isothiazolinone compounds; and / or, The first inorganic metal-supported antibacterial agent and / or the second inorganic metal-supported antibacterial agent comprises at least one of silver-supported zirconium phosphate, silver-supported zinc zirconium phosphate, silver-supported zinc zeolite, silver-supported copper zinc zeolite, silver-supported zinc glass; and / or, The mass ratio of the inorganic antibacterial agent and the organic dispersant in the inorganic antibacterial material is 0.1-5:0.001-0.01; and / or, The mass ratio of the inorganic antibacterial material, the organic antibacterial agent and the first high molecular polymer in the antibacterial substrate is 0.10-20.0:0.010-10.0:70-99; and / or, The mass ratio of the antibacterial substrate and the second high molecular polymer in the antibacterial catheter is 2-15:85-98; and / or, The mass ratio of dopamine, the hydrophilic polymer and the coating antibacterial agent in the antibacterial coating is 8-90:5-90:0.001-10; and / or, The concentration of the oxidizing agent in the coating forming the antibacterial coating is 0.50mg / mL-2.5mg / mL; and / or, The concentration of the reducing agent in the coating forming the antibacterial coating is 6.0mg / mL-12mg / mL.

7. The urinary catheter of claim 6, wherein, The mass ratio of the inorganic antibacterial agent and the organic dispersant in the inorganic antibacterial material is 0.1-4:0.001-0.01; and / or, The mass ratio of the inorganic antibacterial material, the organic antibacterial agent and the first high molecular polymer in the antibacterial substrate is 5.0-15:3.0-8.0:77-92; and / or, The mass ratio of the antibacterial substrate and the second high molecular polymer in the antibacterial catheter is 4-10:90-96; and / or, The mass ratio of dopamine, the hydrophilic polymer and the coating antibacterial agent in the antibacterial coating is 20-80:10-80:0.1-10; and / or, The concentration of the oxidizing agent in the coating forming the antibacterial coating is 0.50mg / mL-2mg / mL; and / or, The concentration of the reducing agent in the coating forming the antibacterial coating is 6.0mg / mL-10mg / mL.

8. A method of manufacturing a urinary catheter according to any one of claims 1-7, c h a r a c t e r i s e d in that Comprising the following steps, S1, mixing the inorganic antibacterial agent and the dispersant to obtain an inorganic antibacterial material, mixing the inorganic antibacterial material, the organic antibacterial agent and the first high molecular polymer to form an antibacterial substrate; S2, blending, melting and extruding the antibacterial substrate and the second high molecular polymer to obtain an antibacterial catheter; S3, mixing dopamine solution, the hydrophilic polymer and the antibacterial agent to form an antibacterial coating coating; S4, immersing the antibacterial catheter in the antibacterial coating coating, taking out, curing to form a urinary catheter.

9. The method of claim 8, wherein the urinary catheter is prepared by, The step of immersing the antibacterial catheter in the antibacterial coating coating, taking out and curing is repeated at least 2 times.

10. The method of claim 9, wherein the urinary catheter is prepared by, The step of immersing the antibacterial catheter in the antibacterial coating coating, taking out and curing is specifically that the temperature of immersing the antibacterial catheter in the antibacterial coating coating is 18-35℃, the immersing time is 15s-2min, and the antibacterial catheter taken out from the antibacterial coating coating is dried for 12-36h; and / or, The step of immersing the antibacterial catheter in the antibacterial coating coating, taking out and curing is repeated 2-4 times.

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