Medical instrument with antibacterial coating as well as preparation method and application of medical instrument

Abstract

The invention relates to the field of antibacterial medical instruments, and discloses a medical instrument with an antibacterial coating and a preparation method and application thereof.The medical instrument comprises a substrate, an antibacterial silver layer, a composite layer and a hydrophilic surface layer, the antibacterial silver layer is formed on the surface of the substrate, and the composite layer comprises precious metal particles and a dispersion matrix; the composite layer comprises an antibacterial silver layer, precious metal particles and a hydrophilic surface layer, the dispersion matrix is used for adhering the antibacterial silver layer, the precious metal particles and the hydrophilic surface layer, the precious metal particles and the dispersion matrix are synchronously applied to the surface of the antibacterial silver layer, and the hydrophilic surface layer is formed on the surface of the composite layer. The adhesive force of the hydrophilic surface layer is improved, and the hydrophilic surface layer is prevented from falling off.

Description

Technical Field

[0001] The present invention relates to the field of antibacterial medical devices, and particularly to a medical device with an antibacterial coating, a preparation method thereof and an application thereof. Background Art

[0002] Surfaces with antibacterial and biocompatible properties are important in many applications. Examples of surfaces with important properties include surfaces intended to come into contact with the human or animal body, including contact with the skin as well as body cavities and the interior of the body. Medical devices intended to come into contact with human or animal blood preferably have properties that avoid and prevent thrombosis.

[0003] Implantable and interventional medical devices are indispensable medical items in many clinical surgical applications and play an important role in human treatment. As the number of patients treated with implantable and interventional medical catheters increases, some potential problems have continuously emerged. Currently, there are some insurmountable problems with traditional catheter surface modification methods. For example, the long-term implantation of implantable and interventional medical catheters in the human body inevitably causes the invasion of external bacteria, and even causes bacterial infection on the catheter surface, which may block the catheter and lead to a series of complications. In the BIP Foley catheter product of the anti-bacterial company (BACTIGUARD AB), by setting a silver layer and palladium and gold particles, the three metals can form a microcurrent on the substrate surface. When the catheter is used, the microcurrent formed by the three metals can prevent bacteria from adhering to the substrate surface, thereby achieving an antibacterial effect. In order to reduce the friction during insertion, a hydrophilic coating is also applied between the surfaces of the catheter. However, the adhesion between the hydrophilic coating and the surface metal is low, and during use, the hydrophilic coating is likely to peel off from the surface layer. Summary of the Invention

[0004] Therefore, it is necessary to provide a medical device with an antibacterial coating, a preparation method thereof and an application thereof, to solve the problem that the existing antibacterial substrate lacks hydrophilic lubricating properties.

[0005] To achieve the above object, the present invention provides a medical device with an antibacterial coating. The medical device includes a substrate, an antibacterial silver layer, a composite layer and a hydrophilic surface layer. The antibacterial silver layer is formed on the surface of the substrate. The composite layer includes noble metal particles and a dispersion matrix. The dispersion matrix is used to adhere the antibacterial silver layer, the noble metal particles and the hydrophilic surface layer. The noble metal particles and the dispersion matrix are simultaneously applied to the surface of the antibacterial silver layer. The hydrophilic surface layer is formed on the surface of the composite layer.

[0006] Further, the composite layer is applied to the surface of the antibacterial silver layer by a composite solution. The composite solution includes a noble metal salt, a reducing agent, a monomer containing an unsaturated double bond and an initiator. The initiator is used to initiate the polymerization of the monomer containing an unsaturated double bond on the surface of the antibacterial silver layer.

[0007] Further, the monomer containing an unsaturated double bond is one or more of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinylpyrrolidone, 2-hydroxyethyl methacrylate, N-isopropylacrylamide polyethylene glycol methacrylate, polyethylene glycol diacrylate, and methoxypolyethylene glycol acrylate.

[0008] The initiator is a photoinitiator.

[0009] Further, the noble metal includes palladium and / or gold.

[0010] Further, the noble metal is gold.

[0011] Further, the substrate includes at least one of the following materials: latex, polysiloxane, polyvinyl chloride, polypropylene, polyurethane, polyester, polytetrafluoroethylene, ethylene-vinyl acetate copolymer, polystyrene, polycarbonate, polyethylene, polyacrylate, polymethacrylate, ABS copolymer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, polyamide, polyimide, silicon wafer, glass sheet, stainless steel, nickel alloy, titanium alloy.

[0012] Further, the antibacterial silver layer contains or does not contain palladium.

[0013] On the other hand, the present invention provides a method for preparing the above-mentioned medical device with an antibacterial coating, including the following steps:

[0014] (1) Applying an antibacterial silver layer on the substrate to form Intermediate I;

[0015] (2) Synchronously applying noble metal particles and a dispersion matrix on the surface of Intermediate I to form a composite layer, obtaining Intermediate II;

[0016] (3) Applying a hydrophilic surface layer on the surface of Intermediate II to obtain the finished product.

[0017] Further, in step (1), the antibacterial silver layer is applied to the surface of the substrate by physical or chemical methods.

[0018] Further, in step (1), the antibacterial silver layer is formed by one of the following methods:

[0019] (1.1) The antibacterial silver layer is formed by dip coating, spraying, or spin coating a silver-containing solution onto the surface of the substrate, followed by drying and curing to form the antibacterial silver layer;

[0020] (1.2) The antibacterial silver layer is formed by immersing the substrate into a silver-containing deposition solution, then depositing metallic silver in the deposition solution onto the substrate, and then drying to form the antibacterial silver layer.

[0021] Further, the formation of the composite layer in step (2) includes the following steps:

[0022] (2.1) Prepare a composite solution, which includes a noble metal salt, a reducing agent, a monomer containing an unsaturated double bond, and an initiator;

[0023] (2.2) Immerse the intermediate I into the composite solution so that the noble metal is reduced and deposited on the antibacterial silver layer;

[0024] (2.3) Take out the intermediate I and activate the initiator so that the monomer containing an unsaturated double bond polymerizes on the substrate surface to obtain intermediate II.

[0025] Further, the hydrophilic surface layer is formed by in-situ polymerization or physical dip coating.

[0026] Further, the in-situ polymerization method includes the following steps:

[0027] (3.1) Prepare an in-situ polymerization solution, which includes a hydrophilic monomer, a hydrophilic polymer, and an initiator;

[0028] (3.2) Apply the in-situ polymerization solution on the surface of the intermediate II;

[0029] (3.3) Activate the initiator so that the hydrophilic monomer polymerizes to form a hydrophilic surface layer;

[0030] Further, the hydrophilic monomer is any one or a combination of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinylpyrrolidone, 2-hydroxyethyl methacrylate, polyethylene glycol methacrylate, polyethylene glycol diacrylate, methoxypolyethylene glycol acrylate, and N-isopropylacrylamide,

[0031] The initiator is a photoinitiator.

[0032] The hydrophilic polymer is one or more of polyethylene glycol, chitosan, polyvinyl alcohol, polyvinylpyrrolidone, polyvinylpyrrolidone-vinyl acetate, polyacrylic acid, polyacrylamide, polyvinylamide, polyoxyethylene, carboxymethyl cellulose, hyaluronic acid, gelatin, sodium aminoglucuronate, or sodium alginate.

[0033] On the other hand, the present invention provides an application of a medical device with an antibacterial coating, and the medical device is an implantable medical device.

[0034] Further, the implantable medical device is a catheter or a stent.

[0035] An application of a medical device with an antibacterial coating, and the medical device is a disposable medical supply.

[0036] The above technical solutions have the following beneficial effects:

[0037] In the present invention, after forming an antibacterial silver layer on the surface of the substrate, in the form of a composite solution, noble metal particles and a dispersion matrix are simultaneously applied to the antibacterial silver layer. The monomers used in the dispersion matrix further initiate polymerization on the surface, dispersing the noble metal particles in the dispersion matrix. The dispersion matrix firmly adheres the noble metal and the antibacterial silver layer. Additionally, the dispersion matrix can also help strengthen the adhesion between the hydrophilic surface layer and the composite layer, making the hydrophilic surface layer not easily fall off and ensuring the lubricating effect of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a cross-section of the substrate, composite layer, and hydrophilic surface layer described in the specific embodiments.

[0039] DESCRIPTION OF THE REFERENCE NUMERALS:

[0040] 1. Substrate; 2. Antibacterial silver layer; 3. Composite layer; 31. Metal particles; 32. Dispersion matrix; 4. Hydrophilic surface layer. SPECIFIC EMBODIMENTS

[0041] As Figure 1 shown, the present invention discloses a medical device with an antibacterial coating, including a substrate 1, an antibacterial silver layer 2, a composite layer 3, and a hydrophilic surface layer 4. The antibacterial silver layer 2 is formed on the surface of the substrate 1. The composite layer 3 includes noble metal particles 31 and a dispersion matrix 32. The noble metal particles 31 and the dispersion matrix 32 are simultaneously applied to the surface of the antibacterial silver layer 2. The hydrophilic surface layer 4 is formed on the surface of the composite layer 3.

[0042] In some embodiments, the coating amount of the antibacterial silver layer is 0.05 - 12 μg / cm 2 .

[0043] In some embodiments, the coating amount of the antibacterial silver layer is 0.05 - 1 μg / cm 2 , 0.05 - 5 μg / cm 2 , 0.05 - 8 μg / cm 2 , 0.05 - 12 μg / cm 2 , 0.5 - 1 μg / cm 2 , 0.5 - 5 μg / cm 2 , 0.5 - 8 μg / cm 2 , 0.5 - 12 μg / cm 2 , 1 - 5 μg / cm 2 , 1 - 8 μg / cm 2 , 1 - 12 μg / cm 2 , 5 - 10 μg / cm 2 or 5 - 12 μg / cm 2 .

[0044] In some embodiments, the dispersion matrix is a hydrophilic polymer.

[0045] In some embodiments, the composite layer is applied to the surface of the antibacterial silver layer by a composite solution, and the composite solution includes a noble metal salt, a reducing agent, a monomer containing an unsaturated double bond, and an initiator.

[0046] In some embodiments, the initiator can be a photoinitiator or a thermal initiator.

[0047] In some embodiments, the monomer containing an unsaturated double bond is one or more of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinylpyrrolidone, 2-hydroxyethyl methacrylate, N-isopropylacrylamide, polyethylene glycol methacrylate, polyethylene glycol diacrylate, and methoxypolyethylene glycol acrylate.

[0048] The initiator is a photoinitiator.

[0049] In some embodiments, the photoinitiator is any one or a combination of more than one of 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone, 2-hydroxy-2-methyl-1-phenyl-1-propanone, α-ketoglutaric acid, aqueous thioxanthone, aqueous benzophenone amide, and acyl phosphate.

[0050] In some embodiments, the noble metal is palladium and / or gold.

[0051] In some embodiments, the material of the metal particles is palladium and gold.

[0052] In some embodiments, the thickness of the hydrophilic surface layer is

[0053] or The thickness of the hydrophilic coating needs to be controlled within a certain range, while ensuring hydrophilic lubricity, it is also necessary to avoid being too thick to isolate the antibacterial effect of the inner metal layer.

[0054] In some embodiments, the substrate includes at least one of the following materials: latex, polysiloxane, polyvinyl chloride, polypropylene, polyurethane, polyester, polytetrafluoroethylene, ethylene-vinyl acetate copolymer, polystyrene, polycarbonate, polyethylene, polyacrylate, polymethacrylate, ABS copolymer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, polyamide, polyimide, silicon wafer, glass sheet, stainless steel, nickel alloy, titanium alloy, etc.

[0055] In some embodiments, the antibacterial silver layer contains or does not contain palladium.

[0056] On the other hand, the present invention provides a method for preparing the above-mentioned medical device with an antibacterial coating, comprising the following steps:

[0057] (1) Apply an antibacterial silver layer on a substrate to form an intermediate I;

[0058] (2) Synchronously apply noble metal particles and a dispersion matrix on the surface of the intermediate I, thereby forming a composite layer to obtain an intermediate II;

[0059] (3) Apply a hydrophilic surface layer on the surface of the intermediate II to obtain a finished product.

[0060] In some embodiments, in step (1), before applying the antibacterial silver layer on the substrate, activation treatment is performed using a stannous salt aqueous solution.

[0061] In some embodiments, in step (1), the antibacterial silver layer is applied to the surface of the substrate by physical or chemical methods.

[0062] In some embodiments, in step (1), the antibacterial silver layer is formed by one of the following methods:

[0063] (1.1) The antibacterial silver layer is formed by applying a silver-containing solution to the surface of the substrate by dip coating, spraying or spin coating, and then drying and curing to form the antibacterial silver layer;

[0064] (1.2) The antibacterial silver layer is formed by immersing the substrate into a silver-containing deposition solution, then depositing metallic silver in the deposition solution onto the substrate, and then drying to form the antibacterial silver layer.

[0065] In some embodiments, a silver solution containing palladium can be applied to the substrate by the above method to form an antibacterial silver layer containing palladium, and then the noble metal particles in the composite layer may or may not contain palladium particles.

[0066] In some embodiments, the silver-containing deposition solution is prepared by mixing a silver salt, a reducing agent and a deposition control agent.

[0067] In some embodiments, the silver salt is silver nitrate, the reducing agent is formaldehyde, and the deposition control agent is one or more of potassium hydroxide, sodium hydroxide, and sodium citrate.

[0068] In some embodiments, the formation of the composite layer in step (2) includes the following steps:

[0069] (2.1) Prepare a composite solution, which includes a noble metal salt, a reducing agent, a monomer containing an unsaturated double bond, and an initiator;

[0070] (2.2) Immerse the intermediate I into the composite solution so that the noble metal is reduced and deposited on the antibacterial silver layer;

[0071] (2.3) Take out Intermediate I, activate the initiator, and polymerize the monomers containing unsaturated double bonds on the substrate surface to obtain Intermediate II.

[0072] In some embodiments, in the composite solution, the reducing agent is one or more of ascorbic acid, alpha-amino acid, and citric acid;

[0073] The monomers containing unsaturated double bonds are one or more of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinylpyrrolidone, 2-hydroxyethyl methacrylate, N-isopropylacrylamide, polyethylene glycol methacrylate, polyethylene glycol diacrylate, and methoxypolyethylene glycol acrylate;

[0074] The initiator is a photoinitiator.

[0075] In some embodiments, the photoinitiator is any one or a combination of 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone, 2-hydroxy-2-methyl-1-phenyl-1-propanone, α-ketoglutaric acid, aqueous thioxanthone, aqueous benzophenone amide, and acyl phosphate.

[0076] In some embodiments, the hydrophilic surface layer is selectively formed by in-situ polymerization or physical dip coating.

[0077] In some embodiments, the in-situ polymerization method includes the following steps:

[0078] (3.1) Prepare an in-situ polymerization solution, which includes hydrophilic monomers, hydrophilic polymers, and initiators;

[0079] (3.2) Apply the in-situ polymerization solution on the surface of Intermediate II;

[0080] (3.3) Activate the initiator to polymerize the hydrophilic monomers to form a hydrophilic surface layer.

[0081] In some embodiments, the hydrophilic monomers are any one or a combination of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinylpyrrolidone, 2-hydroxyethyl methacrylate, polyethylene glycol methacrylate, polyethylene glycol diacrylate, methoxypolyethylene glycol acrylate, and N-isopropylacrylamide. The initiator is a photoinitiator. The hydrophilic polymers are one or more of polyethylene glycol, chitosan, polyvinyl alcohol, polyvinylpyrrolidone, polyvinylpyrrolidone-vinyl acetate, polyacrylic acid, polyacrylamide, polyvinylamide, polyoxyethylene, carboxymethyl cellulose, hyaluronic acid, gelatin, sodium aminoglucanate, or sodium alginate.

[0082] In some embodiments, the photoinitiator is any one or a combination of more than one of 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone, 2-hydroxy-2-methyl-1-phenyl-1-propanone, α-ketoglutaric acid, aqueous thioxanthone, aqueous benzophenone amide, and acyl phosphate,

[0083] The polymerization excitation condition is ultraviolet light irradiation curing.

[0084] On the other hand, the present invention provides an application of a medical device with an antibacterial coating, and the medical device is an implantable medical device.

[0085] In some embodiments, the implantable medical device is a catheter or a stent.

[0086] An application of a medical device with an antibacterial coating, and the medical device is a disposable medical supply.

[0087] To describe in detail the technical content, structural features, achieved purposes, and effects of the technical solution, the following is described in detail with specific embodiments and in conjunction with the accompanying drawings.

[0088] Example 1

[0089] This embodiment provides a medical device with an antibacterial coating. Specifically, the polysiloxane substrate is first cleaned by pickling, rinsed with deionized water, immersed in a 1.2 g / L stannous chloride aqueous solution for 5 minutes, and then rinsed with deionized water to activate the substrate surface. Then, the substrate is immersed in a solution containing 0.006 g / l silver ions, 0.02 ml / l ammonia, 0.06 g / l potassium hydroxide, and 0.0006 ml / l formaldehyde at room temperature for 8 minutes. After cleaning and drying, intermediate I is obtained.

[0090] Prepare a composite solution: Prepare solution A and solution B with deionized water respectively, and then mix the two in a volume ratio of 1:4 to obtain the composite solution

[0091] Solution A: 2% polyethylene glycol diacrylate, 0.1% photoinitiator.

[0092] Solution B: 0.005 g / L palladium ions, 0.005 g / L gold ions, 0.02 ml / l ammonia, 0.05 g / l potassium hydroxide, and 0.0005 ml / l ascorbic acid.

[0093] Immerse intermediate I in the composite solution for 100 s and then lift it out of the liquid surface, and cure it by UV light to obtain intermediate II.

[0094] Prepare an in-situ polymerization solution, immerse Intermediate II in the in-situ polymerization solution II, where the in-situ polymerization solution II includes 2% hydroxyethyl methacrylate, 3% polyvinylpyrrolidone, 3% polyethylene glycol diacrylate, and 0.2% photoinitiator. After an immersion time of 5 - 30 s, followed by UV light curing and drying, a hydrophilic surface layer is formed, and the thickness of the hydrophilic surface layer is controlled to be about 100 nm to obtain a medical device with an antibacterial coating.

[0095] Example 2

[0096] This example provides a medical device with an antibacterial coating. The preparation of Intermediate I and Intermediate II during the preparation process is the same as in Example 1.

[0097] In the formation of the composite layer, prepare a composite solution: Prepare Solution A and Solution B, and then mix the two to obtain the composite solution.

[0098] Solution A: 2% polyethylene glycol diacrylate, 2% polyvinylpyrrolidone, 0.1% photoinitiator.

[0099] Solution B: 0.005 g / L gold ions, 0.02 ml / l ammonia, 0.05 g / l potassium hydroxide, and 0.0005 ml / l ascorbic acid.

[0100] Comparative Example 1

[0101] Provide a medical device with an antibacterial coating. Preparation process: Apply an antibacterial silver layer and noble metal particles successively on the surface of the polysiloxane substrate. The application processes of the antibacterial silver layer and noble metal particles are the same as in Example 1.

[0102] When applying the noble metal particles, the deposition solution of the noble metal includes: 0.005 g / L palladium ions, 0.005 g / L gold ions, 0.02 ml / l ammonia, 0.06 g / l potassium hydroxide, and 0.0006 ml / l ascorbic acid.

[0103] Comparative Example 2

[0104] Provide a medical device with an antibacterial coating. Preparation process: Apply an antibacterial silver layer, noble metal particles, and a hydrophilic surface layer successively on the surface of the polysiloxane substrate. The difference between the antibacterial silver layer, noble metal particles, and hydrophilic surface layer and Example 1 is as follows.

[0105] When applying the noble metal particles, the deposition solution of the noble metal includes: 0.005 g / L palladium ions, 0.005 g / L gold ions, 0.02 ml / l ammonia, 0.06 g / l potassium hydroxide, and 0.0006 ml / l formaldehyde.

[0106] Conduct antibacterial experiment tests and coating adhesion grade tests on the medical devices with antibacterial coatings prepared in Examples 1 - 2 and Comparative Examples 1 - 2 respectively.

[0107] Using a polysiloxane substrate as the control group, the antibacterial experiment was tested with Staphylococcus aureus as the antibacterial object:

[0108] Antibacterial rate = (number of bacteria in the control group - number of bacteria in the experimental group) / number of bacteria in the control group × 100%;

[0109] Table 1, Antibacterial performance and adhesion grade test

[0110]

[0111] It can be seen from the comparison between Examples 1-2 and Comparative Example 1 that although a hydrophilic surface layer is added to the outer surface of the noble metal particles, while ensuring the lubrication of the outer surface of the product, the antibacterial effect of more than 85% can still be maintained. In addition, it can be seen from the comparison between Examples 1-2 and Comparative Example 2 that in the present invention, noble metal particles and a dispersion matrix are simultaneously applied to the outer surface of the antibacterial silver layer. Due to the presence of the dispersion matrix on the composite layer, it is beneficial to improve the adhesion between the subsequent hydrophilic surface layer and the composite layer, improve the adhesion grade of the hydrophilic surface layer, and is beneficial to the actual use of medical products.

[0112] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "comprising", "including" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or terminal device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent to such process, method, article or terminal device. Without further limitation, the elements defined by the statement "including..." or "comprising..." do not exclude the existence of additional elements in the process, method, article or terminal device including the said elements. In addition, in this article, "greater than", "less than", "exceeding" etc. are understood not to include the present number; "above", "below", "within" etc. are understood to include the present number.

[0113] Although the above embodiments have been described, those skilled in the art can make additional changes and modifications once they know the basic creative concept. Therefore, the above description is only the embodiments of the present invention, and does not limit the patent protection scope of the present invention. Any equivalent structure or equivalent process transformation made by using the specification and drawings of the present invention, or directly or indirectly applied in other related technical fields, shall be included in the patent protection scope of the present invention by the same token.

Claims

1. A medical device with an antibacterial coating, characterized in that, It includes a substrate, an antibacterial silver layer, a composite layer, and a hydrophilic surface layer. The antibacterial silver layer is formed on the surface of the substrate. The composite layer includes noble metal particles and a dispersion matrix, and the dispersion matrix is used to adhere the antibacterial silver layer, the noble metal particles, and the hydrophilic surface layer. The noble metal particles and the dispersion matrix are applied synchronously to the surface of the antibacterial silver layer, and the hydrophilic surface layer is formed on the surface of the composite layer.

2. The medical device with an antibacterial coating according to claim 1, characterized in that, The composite layer is applied to the surface of the antibacterial silver layer by a composite solution, and the composite solution includes a noble metal salt, a reducing agent, a monomer containing an unsaturated double bond, and an initiator. The initiator is used to initiate the polymerization of the monomer containing an unsaturated double bond on the surface of the antibacterial silver layer.

3. The medical device with an antibacterial coating according to claim 2, characterized in that, The monomer containing an unsaturated double bond is one or more of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinylpyrrolidone, 2-hydroxyethyl methacrylate, N-isopropylacrylamide, polyethylene glycol methacrylate, polyethylene glycol diacrylate, and methoxypolyethylene glycol acrylate. The initiator is a photoinitiator.

4. The medical device with an antibacterial coating according to claim 1, characterized in that, The noble metal includes palladium and / or gold.

5. The medical device with an antibacterial coating according to claim 1, characterized in that, The noble metal is gold.

6. The medical device with an antibacterial coating according to claim 1, characterized in that, The substrate includes at least one of the following materials: latex, polysiloxane, polyvinyl chloride, polypropylene, polyurethane, polyester, polytetrafluoroethylene, ethylene-vinyl acetate copolymer, polystyrene, polycarbonate, polyethylene, polyacrylate, polymethacrylate, ABS copolymer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, polyamide, polyimide, silicon wafer, glass sheet, stainless steel, nickel alloy, titanium alloy.

7. The medical device with an antibacterial coating according to claim 1, characterized in that, The antibacterial silver layer contains or does not contain palladium.

8. A method for preparing a medical device with an antibacterial coating according to any one of claims 1-7, characterized in that, It includes the following steps: (1) Apply an antibacterial silver layer on the substrate to form Intermediate I; (2) Synchronously apply noble metal particles and a dispersion matrix on the surface of Intermediate I to form a composite layer, obtaining Intermediate II; (3) Apply a hydrophilic surface layer on the surface of Intermediate II to obtain the finished product.

9. The preparation method of the medical device with an antibacterial coating according to claim 8, characterized in that, In step (1), the antibacterial silver layer is applied to the surface of the substrate by a physical or chemical method.

10. The preparation method of the medical device with an antibacterial coating according to claim 9, characterized in that, In step (1), the antibacterial silver layer is formed by one of the following methods: (1.1) The antibacterial silver layer is formed by dip coating, spraying, or spin coating a silver-containing solution onto the surface of the substrate, and then drying and curing to form the antibacterial silver layer; (1.2) The antibacterial silver layer is formed by immersing the substrate into a silver-containing deposition solution, then depositing metallic silver in the deposition solution onto the substrate, and then drying to form the antibacterial silver layer.

11. The preparation method of the medical device with an antibacterial coating according to claim 8, characterized in that, The formation of the composite layer in step (2) includes the following steps: (2.1) Prepare a composite solution, and the composite solution includes a noble metal salt, a reducing agent, a monomer containing an unsaturated double bond, and an initiator; (2.2) Immerse Intermediate I into the composite solution so that the noble metal is reduced and deposited onto the antibacterial silver layer; (2.3) Take out Intermediate I and activate the initiator to polymerize the monomer containing an unsaturated double bond on the surface of the substrate, obtaining Intermediate II.

12. The preparation method of the medical device with an antibacterial coating according to claim 8, characterized in that, The hydrophilic surface layer is formed by in-situ polymerization or physical dip coating.

13. The preparation method of the medical device with an antibacterial coating according to claim 12, characterized in that, The in-situ polymerization method includes the following steps: (3.1) Prepare an in-situ polymerization solution, and the in-situ polymerization solution includes a hydrophilic monomer, a hydrophilic polymer, and an initiator; (3.2) Apply an in-situ polymerization solution to the surface of Intermediate II; (3.3) Activate the initiator to polymerize the hydrophilic monomer to form a hydrophilic surface layer.

14. The preparation method of the medical device with an antibacterial coating according to claim 13, characterized in that, The hydrophilic monomer is any one or a combination of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinylpyrrolidone, 2-hydroxyethyl methacrylate, polyethylene glycol methacrylate, polyethylene glycol diacrylate, methoxypolyethylene glycol acrylate, and N-isopropylacrylamide. The initiator is a photoinitiator. The hydrophilic polymer is one or more of polyethylene glycol, chitosan, polyvinyl alcohol, polyvinylpyrrolidone, polyvinylpyrrolidone-vinyl acetate, polyacrylic acid, polyacrylamide, polyvinylamide, polyoxyethylene, carboxymethyl cellulose, hyaluronic acid, gelatin, sodium aminoglucuronate, or sodium alginate.

15. Use of a medical device with an antibacterial coating according to any one of claims 1-7, characterized in that, The medical device is an implantable medical device.

16. Use of the medical device with an antibacterial coating according to claim 15, characterized in that, The implantable medical device is a catheter or a stent.

17. Use of a medical device with an antibacterial coating according to any one of claims 1-7, characterized in that, The medical device is a disposable medical supply.

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