Medical instrument with antibacterial coating as well as preparation method and application of medical instrument
By forming an antibacterial silver layer on the substrate of the implanted medical catheter and applying hydrophilic coating and precious metal particles to its surface, the problem of bacterial invasion and infection in the human body is solved, and good antibacterial and lubricating properties are achieved.
Patent Information
- Application Number
- CN202411810643.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-10
- Publication Date
- 2025-06-06
AI Technical Summary
Traditional implantable interventional medical catheters are easily implanted in the human body for a long time and can easily lead to bacterial invasion and infection, affecting their antibacterial effects.
An antibacterial silver layer is formed on the substrate, and a hydrophilic coating is applied to its surface. There are precious metal particles distributed on the hydrophilic coating, and the particle size of the precious metal particles does not exceed 1 micron.
The friction coefficient on the surface of medical devices is reduced by hydrophilic coating, and the micro current effect of the antibacterial silver layer is maintained through the distribution of precious metal particles on the hydrophilic coating, achieving good antibacterial and lubricating properties.
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Abstract
Description
Technical Field
[0001] The present invention relates to the field of antibacterial medical devices, in particular to a medical device with an antibacterial coating and a preparation method and application thereof. Background Art
[0002] Surfaces with antimicrobial and biocompatible properties are important in many applications. Examples of surfaces with important properties include those intended to come into contact with the human or animal body, including contact with the skin and in body cavities and interiors. Medical devices intended to come into contact with human or animal blood preferably have properties that avoid thrombosis and thrombosis.
[0003] Implantable medical devices are indispensable medical items in many clinical surgical applications and play an important role in human treatment. With the increasing number of patients treated with implantable medical catheters, some potential problems are constantly emerging. At present, there are some difficult-to-overcome problems in traditional catheter surface modification methods. For example, the long-term implantation of implantable medical catheters in the human body will inevitably cause the invasion of extracorporeal bacteria, and even cause bacterial infection on the catheter surface, which may block the catheter and cause a series of complications. In the BIP Foley catheter product of Bactiguard AB, by setting a silver layer and palladium and gold particles, the three metals can form a microcurrent on the surface of the substrate. When the catheter is used, the microcurrent formed by the three metals can prevent bacteria from adhering to the surface of the substrate, thereby playing an antibacterial effect. In order to ensure the lubricity of the catheter product, Bactiguard AB applies a hydrophilic coating on the outer surface of the precious metal particles of the catheter. However, after the hydrophilic coating completely covers the precious metal particles, the microcurrent formed by the silver layer and the precious metal particles is difficult to reach the surface of the device, thereby affecting the antibacterial effect of the catheter. Summary of the invention
[0004] To this end, it is necessary to provide a medical device with an antibacterial coating and a preparation method and application thereof, so that the substrate has the function of an antibacterial coating and the surface has good lubrication properties to avoid damage to human tissue.
[0005] To achieve the above-mentioned object, the present invention provides a medical device with an antibacterial coating, comprising a substrate, an antibacterial silver layer and a hydrophilic coating, wherein the antibacterial silver layer is formed on the surface of the substrate, the hydrophilic coating is formed on the surface of the antibacterial silver layer, precious metal particles are distributed on the hydrophilic coating, the particle size of the precious metal particles does not exceed 1 micron, and the friction coefficient of the surface of the hydrophilic layer on which the precious metal particles are distributed relative to the surface of the substrate is reduced by at least 70%.
[0006] Furthermore, the hydrophilic coating is a hydrophilic polymer coating.
[0007] Furthermore, the material of the noble metal particles includes gold and / or other noble metals.
[0008] Furthermore, the material of the noble metal particles is gold.
[0009] Furthermore, the particle size of the precious metal particles is 0.001-1 micrometer.
[0010] 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 or more.
[0011] Furthermore, the antibacterial silver layer may or may not contain palladium.
[0012] Another aspect of the present invention discloses a method for preparing the above-mentioned medical device with an antibacterial coating, comprising the following steps:
[0013] (1) applying an antibacterial silver layer on a substrate to form an intermediate I;
[0014] (2) applying a hydrophilic coating on the surface of intermediate I to obtain intermediate II;
[0015] (3) Precious metal particles are applied to the intermediate II to obtain a finished product.
[0016] Furthermore, in the step (1), the antibacterial silver layer is applied to the surface of the substrate by a physical or chemical method.
[0017] Furthermore, in step (1), the antibacterial silver layer is formed by one of the following methods:
[0018] (1.1) The antibacterial silver layer is applied to the surface of the substrate by dipping, spraying or spin coating a silver-containing solution, and then dried and solidified to form the antibacterial silver layer;
[0019] (1.2) The antibacterial silver layer is formed by immersing the substrate in a deposition solution containing silver, and then the metallic silver in the deposition solution is deposited on the substrate, and then dried to form the antibacterial silver layer.
[0020] Furthermore, in step (2), the method for forming the hydrophilic coating includes in-situ polymerization or physical dip coating.
[0021] Furthermore, when the hydrophilic coating is formed by in-situ polymerization, the steps include:
[0022] (2.1) preparing an in-situ polymerization solution, wherein the in-situ polymerization solution includes a hydrophilic monomer and an initiator;
[0023] (2.2) applying an in situ polymerization solution on the surface of the substrate;
[0024] (2.3) The initiator is activated, so that the hydrophilic monomer is polymerized in situ on the surface of the substrate to form a hydrophilic coating.
[0025] Further, the hydrophilic monomer is any one or more of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinyl pyrrolidone, hydroxyethyl methacrylate, polyethylene glycol methacrylate, polyethylene glycol diacrylate, methoxy polyethylene glycol acrylate and N-isopropylacrylamide.
[0026] The initiator is a photoinitiator.
[0027] The hydrophilic polymer is one or more of polyethylene glycol, chitosan, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl pyrrolidone-vinyl acetate, polyacrylic acid, polyacrylamide, polyvinyl amide, polyethylene oxide, carboxymethyl cellulose, hyaluronic acid, gelatin, sodium aminoglucosanate or sodium alginate. Further, in the step (3), the precious metal particles are applied to the hydrophilic coating by physical or chemical methods.
[0028] Furthermore, in step (3), the precious metal particles are applied to the hydrophilic coating by the following method:
[0029] (3.1) The precious metal particles are prepared by immersing the substrate treated in step (2) into a pre-prepared precious metal solution, and the precious metal in the solution is deposited onto the hydrophilic coating, followed by drying.
[0030] Another aspect of the present invention discloses the application of the medical device with the antibacterial coating, wherein the medical device is an implantable medical device.
[0031] Furthermore, the implanted medical device is a catheter or a stent.
[0032] Furthermore, the product is a disposable medical product.
[0033] The above technical solution has the following beneficial effects:
[0034] In the present invention, an antibacterial silver layer, a hydrophilic coating, and precious metal particles are arranged on a substrate. By arranging the hydrophilic coating on the outer surface of the antibacterial silver layer, the friction coefficient of the surface of the medical device is effectively reduced. When the precious metal particles are distributed on the hydrophilic coating, the antibacterial silver layer can still produce a microcurrent effect with the precious metal particles through the hydrophilic coating, thereby achieving the antibacterial function. The particle size of the precious metal particles is limited to less than 1 micron, thereby ensuring the lubrication degree of the surface of the medical device. DETAILED DESCRIPTION
[0035] The present invention discloses a medical device with an antibacterial coating, the medical device comprising a substrate, an antibacterial silver layer and a hydrophilic coating, the antibacterial silver layer is formed on the surface of the substrate, the hydrophilic coating is formed on the surface of the antibacterial silver layer, precious metal particles are distributed on the hydrophilic coating, the particle size of the precious metal particles does not exceed 1 micron, and the friction coefficient of the surface of the hydrophilic layer on which the precious metal particles are distributed relative to the surface of the substrate is reduced by at least 70%.
[0036] In the present invention, the distribution of the noble metal particles on the hydrophilic coating may include:
[0037] (1) distributed on the outer surface of the hydrophilic coating; (2) distributed inside the hydrophilic coating; (3) distributed on the outer surface of the hydrophilic coating and inside the hydrophilic coating.
[0038] Preferably, the precious metal particles are distributed on the surface of the hydrophilic coating and inside the hydrophilic coating.
[0039] In some embodiments, the hydrophilic coating has a thickness no greater than
[0040] In some embodiments, the thickness of the hydrophilic coating is or The thickness of the hydrophilic coating needs to be controlled within a certain range. While ensuring the hydrophilic lubricity, it also needs to avoid being too thick to isolate the antibacterial effect of the inner antibacterial silver layer.
[0041] In some embodiments, the coating amount of the antibacterial silver layer is 0.05-12 μg / cm 2 .
[0042] In some embodiments, the coating amount of the antibacterial silver layer is 0.05-1 μg / cm 2 , 0.05-5μg / cm 2 , 0.05-8μg / cm 2 , 0.05-12μg / cm 2 , 0.5-1μg / cm 2 , 0.5-5μg / cm 2 , 0.5-8μg / cm 2 , 0.5-12μg / cm 2 , 1-5μg / cm 2 , 1-8μg / cm 2 , 1-12μg / cm 2 , 5-10μg / cm 2 or 5-12 μg / cm 2 .
[0043] In some embodiments, the hydrophilic coating is a hydrophilic polymer coating.
[0044] In some embodiments, in some embodiments, the hydrophilic coating is formed by photo-initiated or thermally-initiated polymerization of hydrophilic monomers.
[0045] In some embodiments, the hydrophilic coating is formed by photoinitiated polymerization of hydrophilic monomers, and the hydrophilic monomers are any one or more combinations of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinyl pyrrolidone, hydroxyethyl methacrylate, polyethylene glycol methacrylate, methoxypolyethylene glycol acrylate and N-isopropylacrylamide.
[0046] In some embodiments, the material of the precious metal particles includes gold and / or other precious metals.
[0047] In some embodiments, the material of the metal particles is gold.
[0048] In some embodiments, the amount of the metal particles is 0.001-1 μm.
[0049] In some embodiments, the amount of the metal particles is 0.00l-1μm, 0.00l-0.01μm, 0.00l-0.05μm, 0.00l-0.1μm, 0.00l-0.5μm, 0.01-1μm, 0.0l-0.05μm, 0.0l-0.1μm, 0.0l-0.5μm, 0.05-1μm, 0.05-0.1μm, 0.05-0.5μm, 0.1-1μm, 0.l-0.5μm.
[0050] 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, and titanium alloy.
[0051] In some embodiments, the antimicrobial silver layer may or may not contain palladium.
[0052] Another aspect of the present invention discloses a method for preparing the above-mentioned medical device with an antibacterial coating, comprising the following steps:
[0053] (1) applying an antibacterial silver layer on a substrate to form an intermediate I;
[0054] (2) applying a hydrophilic coating on the surface of intermediate I to obtain intermediate II;
[0055] (3) Precious metal particles are applied to the intermediate II to obtain a finished product.
[0056] In some embodiments, in step (1), before applying the antibacterial silver layer on the substrate, an activation treatment is performed using an aqueous solution of stannous salt.
[0057] In some embodiments, in step (1), the antibacterial silver layer is applied to the surface of the substrate by physical or chemical methods.
[0058] In some embodiments, in step (1), the antibacterial silver layer is formed by one of the following methods:
[0059] (1.1) The antibacterial silver layer is applied to the surface of the substrate by dipping, spraying or spin coating a silver-containing solution, and then dried and solidified to form the antibacterial silver layer;
[0060] (1.2) The antibacterial silver layer is formed by immersing the substrate in a deposition solution containing silver, and then the metallic silver in the deposition solution is deposited on the substrate, and then dried to form the antibacterial silver layer.
[0061] In some embodiments, a silver solution containing palladium may be applied to a substrate by the above method to form an antimicrobial silver layer containing a target, and then the precious metal particles on the outer surface of the hydrophilic coating may or may not contain palladium particles.
[0062] In some embodiments, the silver-containing deposition solution is prepared by mixing a silver salt, a reducing agent, and a deposition control agent.
[0063] In some embodiments, the silver salt is silver nitrate, the reducing agent is formaldehyde, and the deposition control agent includes one or more of ammonia, potassium hydroxide, and sodium hydroxide.
[0064] In some embodiments, in step (2), the method for forming the hydrophilic coating comprises in-situ polymerization or physical dip coating.
[0065] In some embodiments, when the hydrophilic coating is formed by in-situ polymerization, the steps include:
[0066] (2.1) preparing an in-situ polymerization solution, wherein the in-situ polymerization solution comprises a hydrophilic monomer, an initiator and a hydrophilic polymer;
[0067] (2.2) applying an in situ polymerization solution on the surface of the substrate;
[0068] (2.3) The initiator is activated, so that the hydrophilic monomer is polymerized in situ on the surface of the substrate to form a hydrophilic coating.
[0069] Compared with simple coating application, the hydrophilic coating formed by in-situ polymerization has greater adhesion on the substrate, avoiding the shedding of the hydrophilic coating.
[0070] In some embodiments, the initiator is a photoinitiator or a thermal initiator.
[0071] In some embodiments, the hydrophilic monomer is any one or more of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinyl pyrrolidone, hydroxyethyl methacrylate, polyethylene glycol methacrylate, polyethylene glycol diacrylate, methoxypolyethylene glycol acrylate and N-isopropylacrylamide.
[0072] In some embodiments, the initiator is a photoinitiator or a thermal initiator.
[0073] In some embodiments, the photoinitiator is any one or more of 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone, 2-hydroxy-2-methyl-1-phenyl-1-propanone, α-ketoglutaric acid, aqueous thioxanthone, aqueous benzamide and acyl phosphate.
[0074] In some embodiments, the hydrophilic polymer is a combination of one or more of polyethylene glycol, chitosan, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl pyrrolidone-vinyl acetate, polyacrylic acid, polyacrylamide, polyvinyl amide, polyethylene oxide, carboxymethyl cellulose, hyaluronic acid, gelatin, sodium aminoglucosanate or sodium alginate.
[0075] In some embodiments, the thickness of the hydrophilic coating is controlled by controlling process parameters such as the immersion time or number of times.
[0076] In some embodiments, in step (3), the precious metal particles are applied to the hydrophilic coating by physical or chemical methods.
[0077] In some embodiments, in step (3), the noble metal particles are formed by one of the following methods:
[0078] (3.1) The precious metal particles are prepared by immersing the substrate treated in step (2) into a pre-prepared precious metal solution, wherein the precious metal in the solution is deposited onto the hydrophilic coating, and then dried;
[0079] (3.2) The precious metal particles are applied to the surface of the hydrophilic coating by dip coating, spray coating or spin coating, and then dried and solidified.
[0080] In the present invention, in method (3.1), the precious metal particles are applied to the hydrophilic coating via a precious metal solution, and after the application, the precious metal particles are distributed both inside the hydrophilic coating and on the outer surface of the hydrophilic coating. In method (3.2), most of the precious metal particles are distributed on the outer surface of the hydrophilic coating.
[0081] In some embodiments, the preprepared precious metal solution can be prepared from the corresponding precious metal salt aqueous solution, which precious metal salt aqueous solution includes a precious metal salt dissolved in water, a reducing agent and a stabilizer, wherein the reducing agent includes one or more of formaldehyde, hydrazine sulfate, hydrazine hydroxide and hypophosphorous acid, and the deposition controlling agent includes one or more of invert sugar, succinic acid, sodium citrate, sodium acetate, sodium hydroxide, potassium hydroxide, sodium tartrate, potassium tartrate and ammonia.
[0082] In some embodiments, the metal particle suspension is obtained by diluting a concentrated colloidal solution of commercial precious metal particles with deionized water, and the metal particles are composed of palladium, gold, rhodium, ruthenium, osmium or iridium. The time for treating the substrate with the suspension ranges from about a few seconds to about a few minutes or longer. After this treatment, it is rinsed with a solution or water such as deionized water and allowed to dry at room temperature.
[0083] Another aspect of the present invention discloses the use of a medical device with an antimicrobial coating, wherein the medical device is an implantable medical device.
[0084] Furthermore, the implanted medical device is a catheter or a stent.
[0085] Furthermore, the product is a disposable medical product.
[0086] In order to explain the technical content, structural features, achieved objectives and effects of the technical solution in detail, the following is a detailed description in conjunction with specific embodiments.
[0087] Example 1
[0088] This embodiment discloses a medical device with an antibacterial coating, and the preparation process is as follows: the polysiloxane substrate is first cleaned by acid washing, rinsed with deionized water, immersed in a 1.2g / L stannous chloride aqueous solution for 5 minutes, and then rinsed with deionized water to activate the surface of the substrate. Thereafter, the substrate is immersed in a solution containing 0.006g / L silver ions, 0.02ml / L ammonia, 0.06g / L potassium hydroxide and 0.0006ml / L formaldehyde at room temperature for 8 minutes, and the intermediate I is obtained after cleaning and drying.
[0089] The intermediate I was immersed in an in-situ polymerization solution, which included 2% hydroxyethyl methacrylate, 3% polyvinyl pyrrolidone, 3% polyethylene glycol diacrylate, and 0.2% photoinitiator. The intermediate I was taken out of the liquid after being immersed for 100 seconds and cured by UV light to obtain the intermediate II. The hydrophilic layer thickness of the intermediate II was about 1000nm.
[0090] The intermediate II is immersed in a suspension of precious metal particles containing 0.005 g / L palladium and 0.002 g / L gold. After the particles are deposited and dried, the particle size distribution of the palladium particles is 100 nm-300 nm, and the particle size distribution of the gold particles is 100 nm-300 nm, thereby obtaining a medical device with an antibacterial coating.
[0091] Embodiment 2-5
[0092] This embodiment provides a medical device with an antibacterial coating. The preparation of intermediates I and II in the preparation process is the same as that in Example 1.
[0093] Intermediate II was immersed in a suspension of precious metal particles containing 0.005 g / L palladium and 0.002 g / L gold.
[0094] In Examples 2-5, the particle size distribution of palladium particles is controlled to be 1-100nm, 300nm-500nm, 500nm-800nm, 800nm-1000nm; the particle size distribution of gold particles is controlled to be 1-100nm, 300nm-500nm, 500nm-800nm, 800nm-1000nm, respectively. Thus, medical devices with antibacterial coatings are prepared.
[0095] Embodiment 6-7
[0096] This embodiment provides a medical device with an antibacterial coating. The preparation of intermediate I and intermediate II in the preparation process is the same as that in Example 1.
[0097] The intermediate II prepared in Examples 6-7 was immersed in 0.002 g / L gold particle suspension and 0.005 g / L palladium particle suspension, respectively.
[0098] The particle size of the gold particles is distributed in the range of 100 nm to 300 nm. After drying, a medical device having an antibacterial coating is obtained.
[0099] Example 8
[0100] This embodiment discloses a medical device with an antibacterial coating, and the preparation process is as follows: the polysiloxane substrate is first cleaned by acid washing, rinsed with deionized water, immersed in a 1.2g / L stannous chloride aqueous solution for 5 minutes, and then rinsed with deionized water to activate the surface of the substrate. Thereafter, the substrate is immersed in a solution containing 0.005g / L palladium, 0.006g / l silver ions, 0.02ml / l ammonia, 0.06g / l potassium hydroxide and 0.0006ml / l formaldehyde at room temperature for 8 minutes, and the intermediate I is obtained after cleaning and drying.
[0101] The intermediate I was immersed in an in-situ polymerization solution, which included 2% hydroxyethyl methacrylate, 3% polyvinyl pyrrolidone, 3% polyethylene glycol diacrylate, and 0.2% photoinitiator. The intermediate I was taken out of the liquid after being immersed for 100 seconds and cured by UV light to obtain the intermediate II. The hydrophilic layer thickness of the intermediate II was about 1000nm.
[0102] The intermediate II is immersed in a suspension of precious metal particles containing 0.002 g / L gold. After the particles are deposited and dried, the particle size distribution of the gold particles is 100 nm-300 nm, and a medical device with an antibacterial coating is obtained.
[0103] Comparative Example 1
[0104] Provided is a medical device with an antibacterial coating, wherein the preparation process is as follows: an antibacterial silver layer and precious metal particles are applied successively to the surface of a polysiloxane substrate, and the application process of the antibacterial silver layer and the precious metal particles is the same as that of Example 1.
[0105] Comparative Example 2
[0106] Provided is a medical device with an antibacterial coating, wherein the preparation process is as follows: an antibacterial silver layer and a hydrophilic coating are applied successively to the surface of a polysiloxane substrate, and the application process of the antibacterial silver layer and the hydrophilic coating is the same as that of Example 1.
[0107] Comparative Example 3
[0108] Provided is a medical device with an antibacterial coating, wherein the preparation process is as follows: a hydrophilic coating and precious metal particles are applied successively to the surface of a polysiloxane substrate, and the application process of the hydrophilic coating and the precious metal particles is the same as that of Example 1.
[0109] Comparative Example 4
[0110] This embodiment provides a medical device with an antibacterial coating. The preparation of intermediates I and II in the preparation process is the same as that in Example 1.
[0111] Intermediate II was immersed in a suspension of precious metal particles containing 0.005 g / L palladium and 0.002 g / L gold.
[0112] In Examples 2-5, the particle size distribution of palladium particles and gold particles is 1000nm-1500nm, thereby preparing a medical device with an antibacterial coating.
[0113] The medical devices with antibacterial coatings prepared in Examples 1-8 and Comparative Examples 1-4 were subjected to antibacterial experimental tests and lubricity tests, respectively, with polysiloxane as the control group, and Staphylococcus aureus as the antibacterial target in the antibacterial experimental test. The lubricity effect was characterized by the percentage decrease in the friction coefficient, wherein:
[0114] Antibacterial rate = (number of bacteria in the control group - number of bacteria in the experimental group) / number of bacteria in the control group × 100%;
[0115] Lubrication effect = (friction coefficient of control group - friction coefficient of experimental group) / friction coefficient of control group × 100%.
[0116] The results are shown in Table 1
[0117] Table 1, Antibacterial performance and hydrophilic lubricity test
[0118]
[0119] By comparing Examples 1-5 with Comparative Examples 1 and 4, it can be seen that in the absence of a hydrophilic coating, the substrate prepared in Comparative Example 1 increases the surface friction coefficient after applying the antibacterial silver layer and the precious metal particles, while after applying the hydrophilic coating, even after the precious metal particles are applied to the outer surface of the hydrophilic coating, it can still maintain good lubrication properties. At the same time, the particle size of the precious metal particles is limited to below 1000 nm, which can maintain a high antibacterial effect and lubrication effect.
[0120] In Comparative Example 2, no precious metal particles were applied to the outer surface of the hydrophilic coating. Compared with Example 1, its surface had no precious metal particles, and in the antibacterial performance test, its antibacterial performance was significantly less than that of Example 1. In Comparative Example 3, in the hydrophilic coating, no antibacterial silver layer was coated on the surface of the substrate, and the antibacterial effect was not obvious in comparison.
[0121] It should be noted that, in this article, relational terms such as first and second, etc. 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 "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or terminal device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or terminal device. In the absence of further restrictions, the elements defined by the sentence "include..." or "comprise..." do not exclude the existence of other elements in the process, method, article or terminal device including the elements. In addition, in this article, "greater than", "less than", "exceed" and the like are understood to exclude the number itself; "above", "below", "within" and the like are understood to include the number itself.
[0122] Although the above embodiments have been described, once those skilled in the art know the basic creative concepts, they can make additional changes and modifications to these embodiments. Therefore, the above description is only an embodiment of the present invention and does not limit the patent protection scope of the present invention. Any equivalent structure or equivalent process transformation made using the contents of the present invention specification, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present invention.
Claims
1. A medical device with an antibacterial coating, characterized in that: The invention comprises a substrate, an antibacterial silver layer and a hydrophilic coating, wherein the antibacterial silver layer is formed on the surface of the substrate, the hydrophilic coating is formed on the surface of the antibacterial silver layer, precious metal particles are distributed on the hydrophilic coating, the particle size of the precious metal particles does not exceed 1 micron, and the friction coefficient of the surface of the hydrophilic layer on which the precious metal particles are distributed relative to the surface of the substrate is reduced by at least 70%.
2. The medical device with antibacterial coating according to claim 1, characterized in that: The hydrophilic coating is a hydrophilic polymer coating.
3. The medical device with antibacterial coating according to claim 1, characterized in that: The material of the noble metal particles includes gold and / or other noble metals.
4. The medical device with antibacterial coating according to claim 3, characterized in that: The material of the noble metal particles is gold.
5. The medical device with antibacterial coating according to claim 1, characterized in that: The particle size of the noble metal particles is 0.001-1 micron.
6. The medical device with 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 wafer, stainless steel, nickel alloy, titanium alloy or more.
7. The medical device with antibacterial coating according to claim 1, characterized in that: The antimicrobial silver layer may or may not contain palladium.
8. A method for preparing a medical device with an antibacterial coating according to any one of claims 1 to 7, characterized in that: The following steps are involved: (1) applying an antibacterial silver layer on a substrate to form an intermediate I; (2) applying a hydrophilic coating on the surface of intermediate I to obtain intermediate II; (3) Precious metal particles are applied to the intermediate II to obtain a finished product.
9. The method for preparing a medical device with an antibacterial coating according to claim 8, characterized in that: In the step (1), the antibacterial silver layer is applied to the surface of the substrate by a physical or chemical method.
10. The method for preparing a medical device with an antibacterial coating according to claim 9, characterized in that: In the step (1), the antibacterial silver layer is formed by one of the following methods: (1.1) The antibacterial silver layer is applied to the surface of the substrate by dipping, spraying or spin coating a silver-containing solution, and then dried and solidified to form the antibacterial silver layer; (1.2) The antibacterial silver layer is formed by immersing the substrate in a deposition solution containing silver, and then the metallic silver in the deposition solution is deposited on the substrate, and then dried to form the antibacterial silver layer.
11. The method for preparing a medical device with an antibacterial coating according to claim 8, characterized in that: In the step (2), the method for forming the hydrophilic coating includes in-situ polymerization or physical dip coating.
12. The method for preparing a medical device with an antibacterial coating according to claim 11, characterized in that: The hydrophilic coating is formed by in-situ polymerization, comprising the following steps: (2.1) preparing an in-situ polymerization solution, wherein the in-situ polymerization solution comprises a hydrophilic monomer, an initiator and a hydrophilic polymer; (2.2) applying an in situ polymerization solution on the surface of the substrate; (2.3) The initiator is activated, so that the hydrophilic monomer is polymerized in situ on the surface of the substrate to form a hydrophilic coating.
13. The method for preparing a medical device with an antibacterial coating according to claim 11, characterized in that: The hydrophilic monomer is any one or more of acrylic acid, acrylamide, N,N-dimethylacrylamide, N-vinyl pyrrolidone, hydroxyethyl methacrylate, polyethylene glycol methacrylate, polyethylene glycol diacrylate, methoxy polyethylene glycol acrylate and N-isopropylacrylamide. The initiator is a photoinitiator, The hydrophilic polymer is one or more of polyethylene glycol, chitosan, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl pyrrolidone-vinyl acetate, polyacrylic acid, polyacrylamide, polyvinyl amide, polyoxyethylene, carboxymethyl cellulose, hyaluronic acid, gelatin, sodium aminoglucosanate or sodium alginate.
14. The method for preparing a medical device with an antibacterial coating according to claim 8, characterized in that: In the step (3), the precious metal particles are applied to the hydrophilic coating by physical or chemical methods.
15. The method for preparing a medical device with an antibacterial coating according to claim 14, characterized in that: In the step (3), the noble metal particles are applied to the hydrophilic coating by the following method: (3.1) The precious metal particles are prepared by immersing the substrate treated in step (2) into a pre-prepared precious metal solution, and the precious metal is deposited on the hydrophilic coating, followed by drying.
16. Use of a medical device with an antibacterial coating according to any one of claims 1 to 7, characterized in that: The medical device is an implantable medical device.
17. The use of a medical device with an antibacterial coating according to claim 16, characterized in that: The implanted medical device is a catheter or a stent.
18. Use of a medical device with an antibacterial coating according to any one of claims 1 to 7, characterized in that: The medical device is a disposable medical product.