WO2023279664A1 - 一种医疗器械表面用的润滑涂层及其制备方法 - Google Patents

一种医疗器械表面用的润滑涂层及其制备方法 Download PDF

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WO2023279664A1
WO2023279664A1 PCT/CN2021/138086 CN2021138086W WO2023279664A1 WO 2023279664 A1 WO2023279664 A1 WO 2023279664A1 CN 2021138086 W CN2021138086 W CN 2021138086W WO 2023279664 A1 WO2023279664 A1 WO 2023279664A1
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base layer
lubricating
medical device
coating
layer
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PCT/CN2021/138086
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English (en)
French (fr)
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杜学敏
刘美金
王芳
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深圳先进技术研究院
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Publication of WO2023279664A1 publication Critical patent/WO2023279664A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/082Inorganic materials
    • A61L31/086Phosphorus-containing materials, e.g. apatite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/082Inorganic materials
    • A61L31/088Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/02Methods for coating medical devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/06Coatings containing a mixture of two or more compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/08Coatings comprising two or more layers

Definitions

  • the invention belongs to the related technical fields of medical care and sliding materials, and in particular relates to coating materials that can be used for super-smooth surfaces and antibacterial medical devices.
  • medical devices have been widely used in medical and health fields to achieve the purpose of disease diagnosis, prevention, monitoring and treatment.
  • medical devices will not only rub against surrounding tissues and organs, but also be easily contaminated by bacteria and interstitial fluid, which will undoubtedly increase the difficulty of doctors' treatment, aggravate patients' pain, and increase the risk of blood vessel wall damage. Therefore, it is particularly urgent to improve the compatibility and lubricity of medical devices with surrounding tissues and organs, reduce patient discomfort and achieve high treatment efficiency.
  • the object of the present invention is to provide a coating material that can be used for super-smooth surface and antibacterial medical devices.
  • the present invention utilizes lubricating liquid or the lubricating layer of ferroelectric materials, oil gel, hydrogel, silica gel and solar cells perfused with lubricating liquid to reduce the friction between the surface of the medical device and the blood vessel wall, improve its biocompatibility and reduce bacteria Adhesion to medical device surfaces.
  • the present invention provides a lubricating coating for the surface of a medical device, which includes a lubricating layer directly provided on the surface of the medical device, a base layer provided on the surface of the medical device, and a lubricating layer provided on the surface of the base layer;
  • the base layer is selected from ferroelectric material base layer, oil gel base layer, hydrogel base layer, silica gel base layer or solar cell base layer;
  • the lubricating layer is a lubricating layer formed by directly pouring lubricating liquid on the surface of the medical device or the surface of the base layer.
  • the base layer of the ferroelectric material is selected from coatings formed by at least one base material of ferroelectric polymers and inorganic ferroelectric materials.
  • ferroelectric polymer is selected from polyvinylidene fluoride and its copolymers, polytetrafluoroethylene, nylon with an odd number of carbon atoms, polyacrylonitrile, polyimide, polyvinylidene dicyanide, poly One or more of urea, polyphenylcyano ether, polyvinyl chloride, polyvinyl acetate or polypropylene.
  • the polyvinylidene fluoride copolymer is selected from polyvinylidene fluoride-trifluoroethylene copolymer, polyvinylidene fluoride-tetrafluoroethylene copolymer, polyvinylidene fluoride-trifluoroethylene-trifluorochloroethylene copolymer and polyvinylidene fluoride-trifluoroethylene-chlorofluoroethylene copolymers.
  • the inorganic ferroelectric material is selected from one or more of bismuth layered perovskite ferroelectrics, tungsten bronze ferroelectrics and perovskite organometal halide ferroelectrics.
  • the inorganic ferroelectric material includes lead titanate, barium titanate, potassium niobate, lithium niobate, lithium tantalate, bismuth titanate, bismuth ferrite, potassium dihydrogen phosphate, ammonium triglyceride and Roche One or more of salt.
  • the particle size of the inorganic ferroelectric material is 1nm-100 ⁇ m, such as 1nm, 10nm, 50nm, 100nm, 500nm, 1 ⁇ m, 10 ⁇ m or 100 ⁇ m.
  • ferroelectric material base layer is a base layer material formed by mixing ferroelectric polymers and inorganic ferroelectric materials.
  • oil gel base layer is selected from poly(n-butyl methacrylate), polyethylene glycol dimethacrylate, polylauryl methacrylate, polyoctadecyl methacrylate, sodium polystyrene sulfonate 1.
  • the hydrogel base layer is selected from fibrin, cellulose, chitosan, sodium alginate, hyaluronic acid, polyether urethane, polyurethane, elastin, gelatin, agar, starch, cellulose, carrageenan Vegetable gum, carboxymethyl cellulose, carboxymethyl chitin, polyhydroxyethyl methacrylate, methacrylic anhydride gelatin, polymethacrylic acid, polyacrylic acid, polyisopropylacrylamide, polylysine, Poly-L-glutamic acid, polyaspartic acid, polyvinyl alcohol, polyethylene glycol, polyethylene glycol diacrylate, polyvinylpyrrolidone, polylactic acid, polyacrylamide, polymaleic anhydride and its derivatives one or more of
  • the silica gel base layer is selected from polydimethylsiloxane, silicone rubber, silicone resin, silicone oil, silane coupling agent, vulcanized silicone rubber, methyl vulcanized silicone rubber, vulcanized nitrile silicone rubber and vulcanized fluorosilicone rubber A coating formed of at least one base material.
  • the solar cell base layer is selected from the coating formed by using the material used to prepare the solar cell light absorption layer as the base layer material.
  • the material for preparing the light absorbing layer of the solar cell is selected from monocrystalline silicon, polycrystalline silicon, amorphous silicon, copper indium selenide, gallium arsenide, nano- TiO2 crystal, polymethoxyethylhexyloxyphenylene vinylene, Polymethoxydimethyloctyloxy-p-phenyleneethylene, polyhexylthiophene fullerene, TiO2 -based dye-sensitized materials.
  • the base layer is a mixture of base material and solvent, which is coated on the surface of the medical device by spraying, dipping, dripping, spin coating or printing, and the base layer is formed after removing the solvent.
  • the voltage of the high voltage corona polarization is above 10kV, preferably above 20kV.
  • the solvent is water and an organic solvent
  • the organic solvent is preferably selected from dimethyl sulfoxide, N,N-dimethylformamide acetone, trimethyl phosphate, N,N-dimethylformamide, N , One or more of N-dimethylacetamide, propylene glycol, ethylene glycol, ethanol, N-methylpyrrolidone, tetrahydrofuran, tetramethylurea, hexamethylphosphoric acid amide and hexafluoroisopropanol.
  • the mass concentration of the base material in the base material mixture is 1%-50%. Preferably it is 1%-20%. For example 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 12%, 14%, 16%, 18%, 20%, 22%, 24 %, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%, 46%, 48%, 50%.
  • the medical device is an instrument, equipment, appliance and material directly used for a subject.
  • a part or all of the components of the medical device are set in the body of the subject or enter the body of the subject during application.
  • the medical device is a medical device for detection, a medical device for treatment, such as an implantable medical device.
  • Examples include contact lenses, catheters for implants, stents, artificial joints, orthopedic staples, urinary catheters, intravaginal or gastrointestinal devices (gastric tubes, sigmoidoscopes, colonoscopes, gastroscopes), endotracheal tubes, bronchoscopes, dentures , orthodontic devices, intrauterine devices, burn tissue dressings, oral dressings, therapeutic devices, laparoscopes, arthroscopes, dental filling materials, artificial muscle keys, artificial larynx, and subperiosteal implants.
  • the medical device is made of gold, silver, platinum, palladium, aluminum, copper, steel, tantalum, magnesium, nickel, chromium, iron, nickel-titanium alloy, cobalt-chromium alloy, high-nitrogen nickel-free stainless steel, cobalt-chromium-molybdenum alloy , gallium arsenide, titanium, hydroxyapatite, tricalcium phosphate, polylactic acid, carbon fiber, polyglycolic acid, polylactic acid-glycolic acid copolymer, poly ⁇ -(caprolactone), polyanhydride, polyorthoester, Polyvinyl alcohol, polyethylene glycol, polyurethane, polyacrylic acid, poly-N-isopropylacrylamide, poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide), polytetrafluoroethylene , polycarbonate, polyurethane, nitrocellulose, polystyrene, polyethylene, polyethylene terephthalate, polydimethylsi
  • the static contact angle of water on the surface with the lubricating coating for the surface of the medical device is 50°-110°, such as 80°-110°, 70°, 75°, 80°, 85°, 90° °, 95°, 100°, 105°;
  • the dynamic contact angle to water is 0°-10°, such as 1°-5°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°.
  • the lubricating liquid perfusion includes vegetable oil, ethylene glycol, perfluoropolyether, mineral oil, glycerin, paraffin, polyurethane, acrylic polyurethane, silicone oil, fluorine oil, vegetable seed oil, n-decyl alcohol, motor lubrication Oil, kerosene, oleic acid, methyl oleate, ethyl oleate, ferrofluid, thermotropic liquid crystal, ionic liquid, iodoacetic acid, mannitol, eicosapentaenoic acid, alginate, alginic acid, mucopolysaccharide, Soak in at least one of hyaluronic acid, collagen, elastin, allantoin, glucuronic acid, glycolic acid, bone collagen, mushroom liquid, and emodin.
  • the thickness of the lubricating layer is 1nm-1000 ⁇ m, such as 10nm, 20 nm, 30nm, 50nm, 100nm, 200nm, 300nm, 400nm, 500nm, 600nm, 700nm, 800nm, 900nm, 1 ⁇ m, 5 ⁇ m, 10 ⁇ m, 20 ⁇ m, 30 ⁇ m, 50 ⁇ m, 100 ⁇ m, 20 ⁇ m, 30 ⁇ m, 50 ⁇ m, 100 ⁇ m, 200 ⁇ m, 300 ⁇ m, 400 ⁇ m, 500 ⁇ m, 600 ⁇ m, 700 ⁇ m, 800 ⁇ m, 900 ⁇ m.
  • the thickness of the base layer is 100nm-1mm, preferably 100nm-100 ⁇ m, such as 100nm, 200nm, 300nm, 400nm, 500nm, 600nm, 700nm, 800nm, 900nm, 1 ⁇ m, 5 ⁇ m, 10 ⁇ m, 20 ⁇ m, 30 ⁇ m, 50 ⁇ m, 100 ⁇ m, 20 ⁇ m, 30 ⁇ m, 50 ⁇ m, 100 ⁇ m.
  • the present invention provides a preparation method of the lubricating coating on the surface of the medical device, the preparation method comprising the following steps:
  • Lubricating layer provided directly on the surface of medical devices: perfusion of lubricating fluid on the surface of medical devices to form a lubricating layer.
  • Lubricating layer set on the surface of the base layer the lubricating liquid is perfused on the surface of the base layer to form a lubricating layer.
  • step 1) of the second scheme after removing the solvent, a step of performing high-voltage corona polarization on the base layer of the ferroelectric material and the base layer of the solar cell is also included.
  • a medical device with lubricating and antibacterial properties is provided, the surface of the medical device has the lubricating coating for the surface of the medical device, or the lubricating coating for the surface of the medical device is provided on the medical device through the above preparation method. layer.
  • the static contact angle of water on the surface of the medical device with a lubricating coating is 50°-110°, such as 80°-110°, 70°, 75°, 80°, 85°, 90°, 95° °, 100°, 105°;
  • the dynamic contact angle to water is 0°-10°, such as 1°-5°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°.
  • the potential of the surface of the medical device with the lubricating coating is 1-50 V.
  • the part that enters the subject's body during use has the above-mentioned lubricating coating for the surface of the medical device, or the surface of the part that enters the subject's body when the medical device is used is provided with a lubricating coating for the surface of the medical device.
  • Lubricant coatings for medical device surfaces are provided.
  • Another aspect provides the above-mentioned lubricating coating for the surface of a medical device, or the application of the lubricating coating obtained by the above-mentioned preparation method in inhibiting bacterial adhesion.
  • Another aspect provides the above-mentioned lubricating coating for the surface of the medical device, or the application of the lubricating coating obtained by the above-mentioned preparation method in the preparation of a medical device for inhibiting bacterial adhesion.
  • a method for improving the lubricity of the surface of a medical device and simultaneously improving the antibacterial ability of the surface of the medical device is provided.
  • a lubricating coating for the surface of the medical device is provided on the surface of the part that enters the subject's body when the medical device is used through the above-mentioned preparation method.
  • a coating composition for the surface of a medical device comprises an independently provided base material and lubricating oil.
  • the coating composition also includes a solvent.
  • an application of the above-mentioned coating composition for the surface of a medical device in the preparation of a medical device for inhibiting bacterial adhesion is provided.
  • the present invention uses lubricating liquid to infuse medical devices or ferroelectric materials, oil gels, hydrogels, silica gel and lubricating layers of solar cells to reduce the friction between the surface of medical devices and blood vessel walls, and improve their biophase Capacitive and reduce the adhesion of bacteria on the surface of medical devices.
  • the coating material of the present invention that can be used for super-smooth surface and antibacterial medical devices has simple preparation process, long-lasting lubricating effect and stable antibacterial effect.
  • the urinary catheter made of silica gel was sample 1, and the surface of the catheter made of silica gel was perfused with silicone oil to obtain sample 2.
  • the surface sample 2 of the silicone catheter has a static contact angle of 87° to water and a dynamic contact angle of 3° to water, which can prevent bacteria from adhering to the surface of the silicone catheter.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the antibacterial rate of sample 1 was 2%, and the antibacterial rate of sample 2 was 83%.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.
  • the gastroscope surface sample 2 After the above treatment, the gastroscope surface sample 2 has a static contact angle of 87° to water, and a dynamic contact angle of 3° to water, which can prevent bacteria from adhering to the laparoscope surface.
  • the laparoscope surface after the above treatment also has The surface potential can further impede bacterial adhesion.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the antibacterial rate of sample 1 was 1%, and the antibacterial rate of sample 2 was 85%.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.
  • the colonoscope surface sample 2 has a static contact angle of 106° to water and a dynamic contact angle of 5° to water, which can prevent bacteria from adhering to the colonoscope surface.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the antibacterial rate of sample 1 was 3%, and the antibacterial rate of sample 2 was 80%.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.
  • the colonoscope surface sample 2 has a static contact angle of 106° to water and a dynamic contact angle of 5° to water, which can prevent bacteria from adhering to the colonoscope surface.
  • Example 1 Bacteriostasis experiments were carried out on the colonoscope (sample 1) and the colonoscope coated with mannitol-infused sodium alginate coating (sample 2) in Example 4, respectively.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the antibacterial rate of sample 1 was 3%, and the antibacterial rate of sample 2 was 80%.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.
  • the laparoscope surface sample 2 after the above treatment has a static contact angle of 103° to water, and a dynamic contact angle of 2° to water, which can prevent bacteria from adhering to the laparoscope surface.
  • the laparoscope surface after the above treatment is also Possesses a surface potential that further hinders bacterial adhesion.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the antibacterial rate of sample 1 was 3%, and the antibacterial rate of sample 2 was 86%.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.
  • the gastroscope surface sample 2 has a static contact angle of 93° to water and a dynamic contact angle of 3° to water, which can prevent bacteria from adhering to the gastroscope surface.
  • the gastroscope (sample 1) and the gastroscope (sample 2) coated with allantoin perfusion polydimethylsiloxane coating on the surface of Example 6 Bacteriostatic experiments were carried out separately.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the antibacterial rate of sample 1 was 2%, and the antibacterial rate of sample 2 was 88%.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.
  • the surface sample 2 of the artificial muscle key has a static contact angle of 95° to water and a dynamic contact angle of 4° to water, which can prevent bacteria from adhering to the surface of the artificial muscle key.
  • the artificial muscle bond (sample 1) that is not coated with mineral oil on the surface and perfused with polyhexylthiophene fullerene coating and the artificial muscle bond (sample 2) that is coated with mineral oil and perfused with polyhexylthiophene fullerene coating on the surface
  • Bacteriostatic experiments were carried out separately.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the antibacterial rate of sample 1 was 2%, and the antibacterial rate of sample 2 was 83%.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.
  • the mass percentage is 1% of 100 nm lithium tantalate particles were ultrasonically dispersed in dimethyl sulfoxide, and 10% by mass of polyacrylonitrile was dissolved in the above dispersion liquid, and 5 mL of the mixed liquid was coated on a clean material made of polyether by drop coating.
  • the colonoscope surface of ether ketone was dried at 80 °C for 12 h, and then 26 kV high-voltage corona polarization to obtain sample 1. Then, the polarized colonoscope surface coated with polyacrylonitrile composite coating was perfused with emodin to obtain sample 2 .
  • the colonoscope surface sample 1 After the above treatment, the colonoscope surface sample 1 has a static contact angle of 101° to water, and a dynamic contact angle of 2° to water, which can prevent bacteria from adhering to the gastroscope surface.
  • the colonoscope surface after the above treatment also has The surface potential can further impede bacterial adhesion.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the samples were taken out and the coated surface was gently washed with 0.9% NaCl solution, transferred to a new 12-well culture plate, and then 1 mL of TSB medium and an appropriate amount of SYTO 9/PI staining solution were added and incubated for 15 min.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the antibacterial rate of sample 1 was 2%, and the antibacterial rate of sample 2 was 90%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.
  • the mass percentage is 150 of 1% nm potassium dihydrogen phosphate particles are ultrasonically dispersed in dimethyl sulfoxide, 10% by mass of polyurea is dissolved in the above dispersion, and 5 ml of the mixed solution is sprayed on a clean material made of polylactic acid.
  • the surface of the artificial muscle bond was dried at 80 °C for 12 h, and then dried in 26 kV high-voltage corona polarization to obtain sample 1. Then hyaluronic acid was perfused on the surface of the poled artificial muscle bond coated with polyurea composite coating to obtain sample 2.
  • the surface sample 2 of the artificial muscle key has a static contact angle of 103° to water, and a dynamic contact angle of 3° to water, which can prevent bacteria from adhering to the surface of the artificial muscle key.
  • the artificial muscle key after the above treatment The bond surface also has a surface potential that further hinders bacterial adhesion.
  • the antibacterial test method was as follows: Escherichia coli (E. coli) was inoculated in an Erlenmeyer flask containing 10 mL of tryptone soybean broth (TSB), and cultured in a constant temperature shaker for 12 h (37 °C shaking rate 200 r/ min), and then diluted to 1 ⁇ 10 6 CFU/mL bacterial suspension by McFarland turbidimetric method. Samples 1 and 2 with a size of 10 ⁇ 10 mm were placed in a 12-well plate, and 1 mL of the bacterial TSB suspension obtained above was added respectively, and incubated in a 37°C incubator for 48 h.
  • the antibacterial rate of sample 1 was 3%, and the antibacterial rate of sample 2 was 88%.
  • the antibacterial rate (the diameter of the colony in the control group - the diameter of the colony in the treatment group) / (the diameter of the colony in the control group - the diameter of the bacteria cake) ⁇ 100%.
  • the control group is the result of antibacterial experiment on gastroscope without any coating on the surface.
  • the treatment group is the result of antibacterial experiment of sample 1 or 2.

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Abstract

本发明公开了一种医疗器械表面用的润滑涂层及其制备方法,其包括直接在医疗器械表面设置的润滑层、医疗器械表面设置的基层及在基层表面设置的润滑层;所述基层选自铁电材料基层、油凝胶基层、水凝胶基层、硅胶基层或太阳能电池基层;所述润滑层为在医疗器械表面或基层表面进行润滑液灌注所形成的润滑层。所述润滑涂层在医疗器械表面的应用。本发明利用润滑液或润滑液灌注铁电材料、油凝胶、水凝胶、硅胶和太阳能电池的润滑层降低医疗器械表面和血管壁之间的摩擦,提高其生物相容性并降低细菌在医疗器械表面的黏附。本发明的可用于表面超滑、抗菌医疗器械的涂层材料具有制备工艺简单、润滑效果持久以及抗菌效果稳定等优点。

Description

一种医疗器械表面用的润滑涂层及其制备方法 技术领域
本发明属于医疗、滑移材料相关技术领域,尤其涉及可用于表面超滑、抗菌医疗器械的涂层材料。
背景技术
随着医疗技术的发展,医疗器械已广泛应用于医疗卫生等领域以达到疾病诊断、预防、监护和治疗的目的。然而在实际植入过程中,医疗器械不仅会与周围组织器官产生摩擦,而且还易被细菌、组织液等污染,这无疑将增加医生治疗的难度、加剧病人的痛感以及增强血管壁破损的风险。因此,提高医疗器械与周围组织、器官的相容性、润滑性,减轻病人不适以及实现治疗的高效性变得尤为迫切。目前,研究者通常是在医疗器械表面涂覆润滑涂层(CN107412883A)以及在医疗器械表面涂覆负载纳米抗菌物质的方法(CN210813271U)解决医疗器械润滑性以及抗菌问题,但是这些方法操作复杂、得到的医疗器械生物相容性不佳而且难以维持长久的润滑性和抗菌性。因此,为了实现医疗器械在使用过程中持久的润滑性和稳定的抗菌性,提高其可靠性,当前研发新型的润滑效果持久、抗菌效果稳定的可用于表面超滑、抗菌医疗器械的涂层材料的需求尤为迫切。
技术问题
目前,研究者通常是在医疗器械表面涂覆润滑涂层(CN107412883A)以及在医疗器械表面涂覆负载纳米抗菌物质的方法(CN210813271U)解决医疗器械润滑性以及抗菌问题,但是这些方法操作复杂、得到的医疗器械生物相容性不佳而且难以维持长久的润滑性和抗菌性。
技术解决方案
为了解决上述背景技术中所提出的技术问题,本发明的目的在于提供可用于表面超滑、抗菌医疗器械的涂层材料。本发明利用利用润滑液或润滑液灌注铁电材料、油凝胶、水凝胶、硅胶和太阳能电池的润滑层降低医疗器械表面和血管壁之间的摩擦,提高其生物相容性并降低细菌在医疗器械表面的黏附。
为了达到上述目的,本发明所采用的技术方案为:
一方面,本发明提供了医疗器械表面用的润滑涂层,其包括直接在医疗器械表面设置的润滑层、医疗器械表面设置的基层及在基层表面设置的润滑层;
所述基层选自铁电材料基层、油凝胶基层、水凝胶基层、硅胶基层或太阳能电池基层;
所述润滑层为直接在医疗器械表面或基层表面进行润滑液灌注所形成的润滑层。
进一步地,所述铁电材料基层选自由铁电聚合物、无机铁电材料中至少一种基层材料所形成的涂层。
进一步地,所述铁电聚合物选自聚偏氟乙烯及其共聚物、聚四氟乙烯、碳原子数为奇数的尼龙、聚丙烯腈、聚酰亚胺、聚亚乙烯基二氰、聚脲、聚苯基氰基醚、聚氯乙烯、聚醋酸乙烯或聚丙烯中的一种或多种。更优选的,所述聚偏氟乙烯共聚物选自聚偏氟乙烯-三氟乙烯共聚物、聚偏氟乙烯-四氟乙烯共聚物、聚偏氟乙烯-三氟乙烯-三氟氯乙烯共聚物和聚偏氟乙烯-三氟乙烯-氯氟乙烯共聚物。
进一步地,所述无机铁电材料选自铋层状钙钛矿结构铁电体、钨青铜型铁电体和钙钛矿型有机金属卤化物铁电体中的一种或多种。优选的,所述无机铁电材料包括钛酸铅、钛酸钡、铌酸钾、铌酸锂、钽酸锂、钛酸铋、铁酸铋、磷酸二氢钾、硫酸三甘酸氨和罗息盐中的一种或多种。
进一步地,无机铁电材料的粒径为1nm-100µm,例如为1nm、10nm、50nm、100nm、500nm、1µm、10µm或100µm。
进一步地,所述铁电材料基层为由铁电聚合物和无机铁电材料混合形成的基层材料。
进一步地,所述油凝胶基层选自由聚甲基丙烯酸正丁酯、聚乙二醇二甲基丙烯酸酯、聚甲基丙烯酸月桂酯、聚甲基丙烯酸十八酯、聚苯乙烯磺酸钠、聚乙烯二氧噻吩中至少一种基层材料所形成的涂层。
进一步地,所述水凝胶基层选自纤维蛋白、纤维素、壳聚糖、海藻酸钠、透明质酸、聚醚氨酯、聚氨酯、弹性蛋白、明胶、琼脂、淀粉、纤维素、角叉菜胶、羧甲基纤维素、羧甲基甲壳素、聚甲基丙烯酸羟乙酯、甲基丙烯酸酐化明胶、聚甲基丙烯酸、聚丙烯酸、聚异丙基丙烯酰胺、聚赖氨酸、聚L‑谷氨酸、聚天冬氨酸、聚乙烯醇、聚乙二醇、聚乙二醇双丙烯酸酯、聚乙烯吡咯烷酮、聚乳酸、聚丙烯酰胺、聚马来酸酐及其衍生物中的一种或多种
进一步地,所述硅胶基层选自由聚二甲基硅氧烷、硅橡胶、硅树脂、硅油、硅烷偶联剂、硫化硅橡胶、甲基硫化硅橡胶、硫化腈硅橡胶和硫化氟硅橡胶中至少一种基层材料所形成的涂层。
进一步地,所述太阳能电池基层选自由制备太阳能电池光吸收层的材料作为基层材料所形成的涂层。优选地,制备太阳能电池光吸收层的材料选自单晶硅、多晶硅、非晶硅、铜铟硒、砷化镓、纳米TiO 2晶体、聚甲氧基乙基己氧基苯撑乙烯撑、聚甲氧基二甲基辛氧基对苯撑乙撑、聚己基噻吩富勒烯、TiO 2基染料敏化材料。
进一步地,所述基层为将基层材料与溶剂配成基层材料混合液,通过喷涂、浸涂、滴涂、旋涂或打印涂覆在医疗器械表面,并且去除溶剂后形成基层。
进一步地,在去除溶剂后还包括对铁电材料基层、太阳能电池基层材料进行高压电晕极化的步骤。
进一步地,在高压电晕极化的电压为10kV以上,优选为20kV以上。
进一步地,所述溶剂为水和有机溶剂,有机溶剂优选选自二甲基亚砜、N,N-二甲基甲酰胺丙酮、磷酸三甲酯、N,N-二甲基甲酰胺、N,N-二甲基乙酰胺、丙二醇、乙二醇、乙醇、N-甲基吡咯烷酮、四氢呋喃、四甲基脲、六甲基磷酸酰胺和六氟异丙醇中一种或多种。
进一步地,基层材料混合液中基层材料的质量浓度为1%-50%。优选为1%-20%。例如1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、12%、14%、16%、18%、20%、22%、24%、26%、28%、30%、32%、34%、36%、38%、40%、42%、44%、46%、48%、50%。
进一步地,所述医疗器械为直接用于受试者的仪器、设备、器具及材料。优选地,所述医疗器械中的一部分或全部部件设置在受试者体内或者应用时进入受试者体内。所述医疗器械为检测用医疗器械、治疗用医疗器械,例如植入类医疗器械。例如接触镜、植入用导管、支架、人造关节、骨科用固定钉、导尿管、阴道内或消化道器械(胃管、乙状结肠镜、结肠镜、胃镜)、气管内管、支气管镜、义齿、畸齿矫正器、宫内避孕器、烧伤组织敷料、口腔敷料、治疗器械、腹腔镜、关节内窥镜、齿科充填材料、人工肌键、人工喉以及骨膜下植入物。
进一步地,所述医疗器械由金、银、铂、钯、铝、铜、钢、钽、镁、镍、铬、铁、镍钛合金、钴铬合金、高氮无镍不锈钢、钴铬钼合金、砷化镓、钛、羟基磷灰石、磷酸三钙、聚乳酸、碳纤维、聚乙醇酸、聚乳酸-羟基乙酸共聚物、聚ε-(己内酯)、聚酸酐、聚原酸酯、聚乙烯醇、聚乙二醇、聚氨酯、聚丙烯酸、聚N-异丙基丙烯酰胺、聚(环氧乙烷)-聚(环氧丙烷)-聚(环氧乙烷)、聚四氟乙烯、聚碳酸酯、聚氨酯、硝化纤维、聚苯乙烯、聚乙烯、聚对苯二甲酸乙二醇酯、聚二甲基硅氧烷、聚丙烯腈-丁二烯-苯乙烯、聚醚醚酮、氧化硅、氧化钛、氧化铝、氧化锆、氧化铌、有机硅、硅橡胶以及玻璃中的至少一种材料制备而成。
进一步地,具有所述医疗器械表面用的润滑涂层的表面的水的静态接触角为50°-110°,例如为80°-110°、70°、75°、80°、85°、90°、95°、100°、105°;对水的动态接触角为0°-10°,例如为1°-5°、1°、2°、3°、4°、5°、6°、7°、8°、9°、10°。
进一步地,所述润滑液灌注包括通过植物油、乙二醇、全氟聚醚、矿物油、丙三醇、石蜡、聚氨酯、丙烯酸聚氨酯、硅油、氟油、蔬菜籽油、正癸醇、电动机润滑油、煤油、油酸、油酸甲酯、油酸乙酯、铁磁流体、热致液晶、离子液体、碘乙酸、甘露醇、二十碳五烯酸、褐藻胶、海藻酸、粘多糖、透明质酸、胶原蛋白、弹力蛋白、尿囊素、葡萄糖醛酸、甘醇酸、骨胶原、蘑菇液、大黄素中的至少一种进行浸泡。
进一步地,所述润滑层的厚度为1nm-1000μm、例如为10nm、20 nm、30nm、50nm、100nm、200nm、300nm、400nm、500nm、600nm、700nm、800nm、900nm、1μm、5μm、10μm、20μm、30μm、50μm、100μm、20μm、30μm、50μm、100μm、200μm、300μm、400μm、500μm、600μm、700μm、800μm、900μm。
进一步地,所述基层厚度为100nm-1mm,优选为100nm-100μm,例如为100nm、200nm、300nm、400nm、500nm、600nm、700nm、800nm、900nm、1μm、5μm、10μm、20μm、30μm、50μm、100μm、20μm、30μm、50μm、100μm。
另一个方面,本发明提供了所述医疗器械表面用的润滑涂层的制备方法,所述制备方法包括以下步骤:
方案一:
直接在医疗器械表面设置的润滑层:在医疗器械表面进行润滑液灌注形成润滑层。
方案二:
1)在医疗器械表面设置基层:将基层材料配成基层材料混合液,通过喷涂、浸涂、滴涂、旋涂或打印涂覆在医疗器械表面,并且去除溶剂后形成基层;
2)在基层表面设置的润滑层:在基层表面进行润滑液灌注形成润滑层。
进一步地,方案二步骤1)中,在去除溶剂后还包括对铁电材料基层、太阳能电池基层材料进行高压电晕极化的步骤。
再一个方面,提供了一种具有润滑和抗菌性能的医疗器械,所述医疗器械表面具有上述医疗器械表面用的润滑涂层,或者通过上述制备方法在医疗器械设置了医疗器械表面用的润滑涂层。
进一步地,所述医疗器械具有润滑涂层的表面的水的静态接触角为50°-110°,例如为80°-110°、70°、75°、80°、85°、90°、95°、100°、105°;对水的动态接触角为0°-10°,例如为1°-5°、1°、2°、3°、4°、5°、6°、7°、8°、9°、10°。
进一步地,所述医疗器械具有润滑涂层的表面的电势为1-50 V。
进一步地,所述医疗器械中,使用时进入受试者体内的部分具有上述医疗器械表面用的润滑涂层,或者通过上述制备方法在医疗器械使用时进入受试者体内的部分的表面设置了医疗器械表面用的润滑涂层。
再一个方面,提供了上述医疗器械表面用的润滑涂层,或者通过上述制备方法获得的润滑涂层抑制细菌黏附中的应用。
再一个方面,提供了上述医疗器械表面用的润滑涂层,或者通过上述制备方法获得的润滑涂层在制备抑制细菌黏附的医疗器械中的应用。
再一个方面,提供了一种提高医疗器械表面润滑性,同时提高医疗器械表面抗菌能力的方法,所述方法为在医疗器械使用时进入受试者体内的部分设置上述医疗器械表面用的润滑涂层,或者通过上述制备方法在医疗器械使用时进入受试者体内的部分的表面设置了医疗器械表面用的润滑涂层。
再一个方面,提供了一种医疗器械表面用涂层组合物,所述组合物包含独立设置的基层材料,以及润滑油。
进一步地,所述涂层组合物中还包含溶剂。
再一个方面,提供了上述医疗器械表面用涂层组合物在制备抑制细菌黏附的医疗器械中的应用。
有益效果
本发明的有益效果是:
(1)本发明利用润滑液灌注医疗器械或润滑液灌注铁电材料、油凝胶、水凝胶、硅胶和太阳能电池的润滑层降低医疗器械表面和血管壁之间的摩擦,提高其生物相容性并降低细菌在医疗器械表面的黏附。
(2)本发明的可用于表面超滑、抗菌医疗器械的涂层材料具有制备工艺简单、润滑效果持久以及抗菌效果稳定。
本发明的实施方式
为更好的说明本发明的目的、技术方案和优点,下面将结合具体实施例对本发明作进一步说明,但本发明的保护内容不局限以下实施例。
实施例1
材质为硅胶的导尿管为样品1,再在材质为硅胶的导尿管表面进行硅油灌注,获得样品2。
经过上述处理后的硅胶导尿管表面样品2对水的静态接触角为87°,对水的动态接触角为3°,可防止细菌在硅胶导尿管表面的黏附。
对实施例1表面未涂覆硅油的导尿管(样品1)和表面涂覆硅油的导尿管(样品2)分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为2%,样品2抑菌率为83%。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
实施例2
将质量百分数为10%的聚偏氟乙烯溶于二甲基亚砜中,取5 mL聚偏氟乙烯溶液通过滴涂的方法涂覆在干净的材质为聚醚醚酮的胃镜表面,80 ℃烘干12 h,然后采用26 kV高压电晕极化,获得样品1。再在极化后的涂覆聚偏氟乙烯涂层的胃镜表面进行硅油灌注,获得样品2。
经过上述处理后的胃镜表面样品2对水的静态接触角为87°,对水的动态接触角为3°,可防止细菌在腹腔镜表面的黏附,此外经过上述处理后的腹腔镜表面还具有表面电势,可进一步阻碍细菌黏附。
对实施例2表面未涂覆硅油灌注聚偏氟乙烯涂层的胃镜(样品1)和表面涂覆硅油灌注聚偏氟乙烯涂层的胃镜(样品2)分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为1%,样品2抑菌率为85%。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
实施例3
将质量百分数为10%的聚甲基丙烯酸月桂酯溶于乙二醇中,取5 mL聚甲基丙烯酸月桂酯溶液通过旋涂的方法涂覆在干净的材质为镍钛合金的结肠镜表面,70 ℃烘干12 h ,获得样品1。再在涂覆聚甲基丙烯酸月桂酯涂层的结肠镜表面进行石蜡灌注,获得样品2。
经过上述处理后的结肠镜表面样品2对水的静态接触角为106°,对水的动态接触角为5°,可防止细菌在结肠镜表面的黏附。
对实施例3表面未涂覆石蜡灌注聚甲基丙烯酸月桂酯涂层的结肠镜(样品1)和表面涂覆石蜡灌注聚甲基丙烯酸月桂酯涂层的结肠镜(样品2)分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为3%,样品2抑菌率为80%。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
实施例4
将质量百分数为4%的海藻酸钠溶于水中,取5 mL海藻酸钠溶液通过喷涂的方法涂覆在干净的材质为氧化锆的结肠镜表面,70 ℃烘干12 h ,获得样品1。再在涂覆海藻酸钠涂层的结肠镜表面进行甘露醇灌注,获得样品2。
经过上述处理后的结肠镜表面样品2对水的静态接触角为106°,对水的动态接触角为5°,可防止细菌在结肠镜表面的黏附。
对实施例4表面未涂覆甘露醇灌注海藻酸钠涂层的结肠镜(样品1)和表面涂覆甘露醇灌注海藻酸钠涂层的结肠镜(样品2)分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为3%,样品2抑菌率为80%。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
实施例5
将质量百分数为10%的聚酰亚胺溶于N,N-二甲基甲酰胺中,取5 ml 聚酰亚胺溶液通过浸涂的方法涂覆在干净的材质为磷酸三钙的腹腔镜表面,80 ℃烘干12 h,然后采用26 kV高压电晕极化,获得样品1。再在极化后的涂覆聚酰亚胺涂层的腹腔镜表面进行海藻酸灌注,获得样品2。
经过上述处理后的腹腔镜表面样品2对水的静态接触角为103°,对水的动态接触角为2°,可防止细菌在腹腔镜表面的黏附,此外经过上述处理后的腹腔镜表面还具有表面电势,可进一步阻碍细菌黏附。
对实施例5表面未涂覆海藻酸灌注聚酰亚胺涂层的腹腔镜(样品1)和表面涂覆海藻酸灌注聚酰亚胺涂层的腹腔镜分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为3%,样品2抑菌率为86%。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
实施例6
将质量百分数为10%的聚二甲基硅氧烷溶于四氢呋喃中,取5 mL 聚二甲基硅氧烷溶液通过打印的方法涂覆在干净的材质为聚乳酸的胃镜表面,80 ℃烘干12 h,获得样品1。再在涂覆聚二甲基硅氧烷涂层的胃镜表面进行尿囊素灌注,获得样品2。
经过上述处理后的胃镜表面样品2对水的静态接触角为93°,对水的动态接触角为3°,可防止细菌在胃镜表面的黏附。
对实施例6表面未涂覆尿囊素灌注聚二甲基硅氧烷涂层的胃镜(样品1)和表面涂覆尿囊素灌注聚二甲基硅氧烷涂层的胃镜(样品2)分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为2%,样品2抑菌率为88%。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
实施例7
将质量百分数为3%的聚己基噻吩富勒烯溶于二甲基亚砜中,取5 mL 聚己基噻吩富勒烯溶液通过喷涂的方法涂覆在干净的材质为钛的人工肌键表面,80 ℃烘干12 h,获得样品1。再在涂覆聚己基噻吩富勒烯涂层的人工肌腱表面进行矿物油灌注,获得样品2。
经过上述处理后的人工肌键表面样品2对水的静态接触角为95°,对水的动态接触角为4°,可防止细菌在人工肌键表面的黏附。
对实施例7表面未涂覆矿物油灌注聚己基噻吩富勒烯涂层的人工肌键(样品1)和表面涂覆矿物油灌注聚己基噻吩富勒烯涂层的人工肌键(样品2)分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为2%,样品2抑菌率为83%。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
实施例8
将质量百分数为1%的100 nm钽酸锂颗粒超声分散在二甲基亚砜中,将质量百分数10%的聚丙烯腈溶于上述分散液中,取5 mL混合液通过滴涂的方法涂覆在干净的材质为聚醚醚酮的结肠镜表面,80 ℃烘干12 h,然后采用26 kV高压电晕极化,获得样品1。再在极化后的涂覆聚丙烯腈复合涂层的结肠镜表面进行大黄素灌注,获得样品2 。
经过上述处理后的结肠镜表面样品1对水的静态接触角为101°,对水的动态接触角为2°,可防止细菌在胃镜表面的黏附,此外经过上述处理后的结肠镜表面还具有表面电势,可进一步阻碍细菌黏附。
对实施例8表面未涂覆大黄素灌注聚丙烯腈复合涂层的结肠镜(样品1)和表面涂覆大黄素灌注聚丙烯腈复合涂层的结肠镜(样品2)分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为2%,样品2抑菌率为90%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
实施例9
将质量百分数为1%的150 nm磷酸二氢钾颗粒超声分散在二甲基亚砜中,将质量百分数10%的聚脲溶于上述分散液中,取5 ml 混合液通过喷涂的方法涂覆在干净的材质为聚乳酸的人工肌键表面,80 ℃烘干12 h,然后采用26 kV高压电晕极化,获得样品1。再在极化后的涂覆聚脲复合涂层的人工肌键表面进行透明质酸灌注,获得样品2。
经过上述处理后的人工肌键表面样品2对水的静态接触角为103°,对水的动态接触角为3°,可防止细菌在人工肌键表面的黏附,此外经过上述处理后的人工肌键表面还具有表面电势,可进一步阻碍细菌黏附。
对实施例9表面未涂覆透明质酸灌注聚脲复合涂层的人工肌键(样品1)和表面涂覆透明质酸灌注聚脲复合涂层的人工肌键(样品2)分别进行抑菌实验。
抑菌实验方法为:采用大肠杆菌(E. coli)接种于包含10 mL胰蛋白胨大豆肉汤培养基(TSB)的三角烧瓶中,在恒温摇床中培养12 h (37℃振荡速率 200 r/min),然后用麦氏比浊法分别稀释成1×10 6 CFU/mL的细菌悬浮液。将10×10 mm大小的样品1和样品2置于12孔板中,分别加入1 mL上述得到的细菌TSB悬浮液,37℃培养箱培养48 h。孵化后取出样品用0.9% NaCl溶液温和的清洗涂层表面,转移至新的12孔培养板中,然后再加入1 mL TSB培养基和适量的SYTO 9/PI染液,培养15 min。
将样品放置于10 mL 0.9% NaCl溶液中超声清洗10 min (200 W,40 kHz ),促使粘附在样品表面的细菌分散于NaCl溶液中,然后取其100 μL用于涂板法观察细菌生长状况,实验结果均重复至少3次。
样品1抑菌率为3%,样品2抑菌率为88%。其中抑菌率=(对照组菌落直径-处理组菌落直径)/(对照组菌落直径-菌饼直径)×100%。其中对照组为表面没有任何涂层胃镜进行抑菌实验结果。处理组为样品1或2的进行抑菌实验结果。
最后所应当说明的是,以上实施例仅用以说明本发明的技术方案而非对本发明保护范围的限制,尽管参照较佳实施例对本发明作了详细说明,本领域的普通技术人员应当理解,可以对本发明的技术方案进行修改或者等同替换,而不脱离本发明技术方案的实质和范围。

Claims (11)

  1. 医疗器械表面用的润滑涂层,其特征在于,其包括直接在医疗器械表面设置的润滑层,或者医疗器械表面设置的基层及在基层表面设置的润滑层;
    所述基层选自铁电材料基层、油凝胶基层、水凝胶基层、硅胶基层或太阳能电池基层中的至少一种;
    所述润滑层为直接在医疗器械表面或基层表面进行润滑液灌注所形成的润滑层。
  2. 根据权利要求1所述的润滑涂层,其特征在于,所述铁电材料基层选自由铁电聚合物、无机铁电材料中的至少一种基层材料所形成的涂层;
    所述油凝胶基层选自由聚甲基丙烯酸正丁酯、聚乙二醇二甲基丙烯酸酯、聚甲基丙烯酸月桂酯、聚甲基丙烯酸十八酯、聚苯乙烯磺酸钠、聚乙烯二氧噻吩中至少一种基层材料所形成的涂层;
    所述水凝胶基层选自纤维蛋白、纤维素、壳聚糖、海藻酸钠、透明质酸、聚醚氨酯、聚氨酯、弹性蛋白、明胶、琼脂、淀粉、纤维素、角叉菜胶、羧甲基纤维素、羧甲基甲壳素、聚甲基丙烯酸羟乙酯、甲基丙烯酸酐化明胶、聚甲基丙烯酸、聚丙烯酸、聚异丙基丙烯酰胺、聚赖氨酸、聚L‑谷氨酸、聚天冬氨酸、聚乙烯醇、聚乙二醇、聚乙二醇双丙烯酸酯、聚乙烯吡咯烷酮、聚乳酸、聚丙烯酰胺、聚马来酸酐及其衍生物中的一种或多种
    所述硅胶基层选自由聚二甲基硅氧烷、硅橡胶、硅树脂、硅油、硅烷偶联剂、硫化硅橡胶、甲基硫化硅橡胶、硫化腈硅橡胶和硫化氟硅橡胶中至少一种基层材料所形成的涂层;
    所述太阳能电池基层选自由制备太阳能电池光吸收层的材料作为基层材料所形成的涂层;
    优选地,所述铁电聚合物选自聚偏氟乙烯及其共聚物、聚四氟乙烯、碳原子数为奇数的尼龙、聚丙烯腈、聚酰亚胺、聚亚乙烯基二氰、聚脲、聚苯基氰基醚、聚氯乙烯、聚醋酸乙烯或聚丙烯中的一种或多种;更优选的,所述聚偏氟乙烯共聚物包括聚偏氟乙烯-三氟乙烯共聚物、聚偏氟乙烯-四氟乙烯共聚物、聚偏氟乙烯-三氟乙烯-三氟氯乙烯共聚物和聚偏氟乙烯-三氟乙烯-氯氟乙烯共聚物;
    优选地,所述无机铁电材料选自铋层状钙钛矿结构铁电体、钨青铜型铁电体和钙钛矿型有机金属卤化物铁电体中的一种或多种;更优选的,所述无机铁电材料选自钛酸铅、钛酸钡、铌酸钾、铌酸锂、钽酸锂、钛酸铋、铁酸铋、磷酸二氢钾、硫酸三甘酸氨和罗息盐中的一种或多种;
    优选地,制备太阳能电池光吸收层的材料选自单晶硅、多晶硅、非晶硅、铜铟硒、砷化镓、纳米TiO 2晶体、聚甲氧基乙基己氧基苯撑乙烯撑、聚甲氧基二甲基辛氧基对苯撑乙撑、聚己基噻吩富勒烯、TiO 2基染料敏化材料。
  3. 根据权利要求1所述的润滑涂层,其特征在于,所述油凝胶选自聚甲基丙烯酸正丁酯、聚乙二醇二甲基丙烯酸酯、聚甲基丙烯酸月桂酯、聚甲基丙烯酸十八酯、聚苯乙烯磺酸钠、聚乙烯二氧噻吩。
  4. 根据权利要求1所述的润滑涂层,其特征在于,所述基层为将基层材料与溶剂配成基层材料混合液,通过喷涂、浸涂、滴涂、旋涂或打印涂覆在医疗器械表面,并且去除溶剂后形成基层;
    优选地,在去除溶剂后还包括对铁电材料基层、太阳能电池基层材料进行高压电晕极化的步骤;
    优选地,所述溶剂为水和有机溶剂;
    优选地,基层材料混合液中基层材料的质量浓度为1%-50%。
  5. 根据权利要求1所述的润滑涂层,其特征在于,所述润滑液灌注包括通过植物油、乙二醇、全氟聚醚、矿物油、丙三醇、石蜡、聚氨酯、丙烯酸聚氨酯、碘乙酸、甘露醇、二十碳五烯酸、褐藻胶、海藻酸、粘多糖、透明质酸、胶原蛋白、弹力蛋白、尿囊素、葡萄糖醛酸、甘醇酸、骨胶原、蘑菇液、大黄素硅油中的至少一种进行浸泡;
    优选地,所述润滑层的厚度为1nm-1000μm、例如为10nm、20 nm、30nm、50nm、100nm、200nm、300nm、400nm、500nm、600nm、700nm、800nm、900nm、1μm、5μm、10μm、20μm、30μm、50μm、100μm、20μm、30μm、50μm、100μm、200μm、300μm、400μm、500μm、600μm、700μm、800μm、900μm。
  6. 根据权利要求1所述的润滑涂层,其特征在于,所述医疗器械为直接用于受试者的仪器、设备、器具及材料;
    优选地,所述医疗器械中的一部分或全部部件设置在受试者体内或者应用时进入受试者体内;
    优选地,所述医疗器械为检测用医疗器械、治疗用医疗器械,更优选为接触镜、植入用导管、支架、人造关节、骨科用固定钉、导尿管、阴道内、消化道器械、胃管、乙状结肠镜、结肠镜、胃镜、气管内管、支气管镜、义齿、畸齿矫正器、宫内避孕器、烧伤组织敷料、口腔敷料、治疗器械、腹腔镜、关节内窥镜、齿科充填材料、人工肌键、人工喉以及骨膜下植入物;
    优选地,所述医疗器械由金、银、铂、钯、铝、铜、钢、钽、镁、镍、铬、铁、镍钛合金、钴铬合金、高氮无镍不锈钢、钴铬钼合金、砷化镓、钛、羟基磷灰石、磷酸三钙、聚乳酸、碳纤维、聚乙醇酸、聚乳酸-羟基乙酸共聚物、聚ε-(己内酯)、聚酸酐、聚原酸酯、聚乙烯醇、聚乙二醇、聚氨酯、聚丙烯酸、聚N-异丙基丙烯酰胺、聚(环氧乙烷)-聚(环氧丙烷)-聚(环氧乙烷)、聚四氟乙烯、聚碳酸酯、聚氨酯、硝化纤维、聚苯乙烯、聚乙烯、聚对苯二甲酸乙二醇酯、聚二甲基硅氧烷、聚丙烯腈-丁二烯-苯乙烯、聚醚醚酮、氧化硅、氧化钛、氧化铝、氧化锆、氧化铌、有机硅、硅橡胶以及玻璃中的至少一种材料制备而成。
  7. 根据权利要求1所述的润滑涂层,其特征在于,所述基层的厚度为100nm-1mm,优选为100nm-100μm。
  8. 权利要求1-7任一项所述医疗器械表面用的润滑涂层的制备方法,所述制备方法包括以下步骤:
    方案一:
    直接在医疗器械表面设置的润滑层:在医疗器械表面进行润滑液灌注形成润滑层;或者
    方案二:
    1)在医疗器械表面设置基层:将基层材料配成基层材料混合液,通过喷涂、浸涂、滴涂、旋涂或打印涂覆在医疗器械表面,并且去除溶剂后形成基层;
    2)在基层表面设置的润滑层:在基层表面进行润滑液灌注形成润滑层;
    进一步地,方案二步骤1)中,在去除溶剂后还包括对铁电材料基层、太阳能电池基层材料进行高压电晕极化的步骤。
  9. 一种具有润滑和抗菌性能的医疗器械,所述医疗器械表面具有权利要求1-7任一项所述医疗器械表面用的润滑涂层,或者通过权利要求8所述制备方法在医疗器械设置了医疗器械表面用的润滑涂层。
  10. 权利要求1-7任一项所述医疗器械表面用的润滑涂层,或者通过权利要求8所述制备方法获得的润滑涂层在制备抑制细菌黏附的医疗器械中的应用。
  11. 一种医疗器械表面用涂层组合物,所述组合物包含独立设置的基层材料,以及润滑油;优选地,所述涂层组合物中还包含溶剂。
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