Method for irradiation sterilization of a medical device and use thereof

Abstract

The application discloses a kind of irradiation sterilization method of medical instrument and its application, the irradiation sterilization method of medical instrument includes the following steps: first, medical instrument is pretreated, then the medical instrument after pretreatment is immersed in bacteriostatic solution and dried, then sterilized under electromagnetic wave, the electromagnetic wave includes at least one of gamma ray, X ray, ultraviolet ray;The irradiation sterilization method of medical instrument provided by the application can not only sterilize the medical instrument, but also coat an antibacterial coating on the outer surface and inner surface of the medical instrument by radiation crosslinking, with an antibacterial effect of up to 96.20%. The method can be mass-produced in industry, and is simple to operate, time-saving and labor-saving.

Description

Technical Field

[0001] This invention relates to the field of medical devices, classified under A61L2 / 08, and specifically to an irradiation sterilization method for medical devices and its application. Background Technology

[0002] Existing disinfection methods for medical devices mainly include physical disinfection, chemical disinfection, and biological disinfection. Biological disinfection primarily uses bacteriophages and antibiotics, but its sterilization rate is relatively low. Chemical disinfection mainly uses disinfectants and sterilizing agents, but disinfectants need to be prepared at different concentrations depending on the device being disinfected, making it extremely inconvenient to use and the disinfection effect is not guaranteed. Long-term contact with disinfectants can also cause serious damage to the skin and nails of medical personnel. Therefore, physical disinfection methods, such as gamma-ray irradiation disinfection, are not only thorough and pollution-free, but also simple, quick, and harmless to the human body.

[0003] In addition to sterilizing medical devices, ensuring they possess good antibacterial properties is also a major research focus. Current technologies typically involve applying an antibacterial coating to the surface of medical devices to achieve this effect. However, these coatings often contain metal nanoparticles. For example, Chinese patent CN104194424B discloses a silver-containing titanium dioxide antibacterial coating, which, while exhibiting good antibacterial properties, has an extremely complex preparation process and carries the risk of heavy metal ion shedding and causing contamination. Similarly, European patent application EP0761243A1 describes a coating formed by immersing the device in a solution of triclosan and other additives, followed by drying. However, because medical devices are made of various materials, these materials are difficult to bond stably and continuously with triclosan. Therefore, current technologies generally suffer from poor adhesion between antibacterial coatings and medical devices made of different materials.

[0004] Chinese patent CN101366954B discloses a sterilization method for a bio-coated medical device. It uses a specific protective agent to solve the destructive effect of gamma ray irradiation sterilization on the bioactive coating, but it does not solve the problem of poor adhesion between the antibacterial coating and the medical device.

[0005] Chinese patent CN108610760B discloses a polyethylene composite antibacterial coating containing silver nanoparticles and its preparation method. The antibacterial coating is mainly prepared by using silver nanoparticles, xylene, polyethylene and other substances. It has good antibacterial properties, but the silver nanoparticles are heavy metals and there is a risk of them falling off. In addition, there are toxic solvents such as xylene in it, which can be harmful to the human body when they evaporate. Summary of the Invention

[0006] To address the aforementioned problems, a first aspect of the present invention provides an irradiation sterilization method for medical devices, comprising the following steps: firstly, pre-treating the medical device; then, immersing the pre-treated medical device in an antibacterial solution and drying it; and finally sterilizing it under electromagnetic waves, wherein the electromagnetic waves include at least one of gamma rays, X-rays, and ultraviolet rays.

[0007] A further preferred embodiment of the irradiation sterilization method for the medical device includes the following steps: first, the medical device is sonicated in an ethanol solution, then rinsed with deionized water 2-3 times, and dried to obtain a pretreated medical device; then, the medical device is immersed in an antibacterial solution for 0.5-2 hours, dried, and then irradiated with electromagnetic waves.

[0008] Preferably, the raw materials for synthesizing the antibacterial liquid include monomers, halogenated hydrocarbons, initiators, and solvents.

[0009] More preferably, the initiator includes at least one selected from 2-hydroxy-2-methyl-1-phenyl-1-propanone, α-ketoglutaric acid, ammonium persulfate, potassium persulfate, benzoyl peroxide, benzophenone, 4-methylbenzophenone, and azobisisobutyronitrile, and the solvent is ethanol.

[0010] More preferably, the initiator is potassium persulfate.

[0011] Preferably, the monomer includes a first monomer, a hydrophilic olefin monomer, and a hydroxyl-containing ester monomer.

[0012] More preferably, the first monomer includes at least one of N,N'-methylenebisacrylamide, N-isopropylacrylamide, N,N-dimethylacrylamide, and N,N-diethylacrylamide, and the hydrophilic olefin monomer includes at least one of N-hydroxymethylacrylamide, N-hydroxyethylacrylamide, N-(2-hydroxypropyl)methylacrylamide, N-(2-hydroxyethyl)-2-methyl-2-acrylamide, and 2,4-vinylpyridine.

[0013] More preferably, the first monomer is N-isopropylacrylamide, and the hydrophilic olefin monomer is 2,4-vinylpyridine.

[0014] Preferably, nano-titanium dioxide is also added to the antibacterial solution.

[0015] More preferably, the average particle size of the nano-titanium dioxide is 30-50 nm.

[0016] More preferably, the average particle size of the nano-titanium dioxide is 40 nm.

[0017] More preferably, the hydroxyl-containing ester monomer includes at least one of hydroxyethyl methacrylate, hydroxyethyl acrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate, and hydroxybutyl acrylate.

[0018] More preferably, the hydroxyl-containing ester monomer is hydroxyethyl methacrylate.

[0019] Preferably, the molar ratio of the first monomer, the hydroxyl-containing ester monomer, the hydrophilic olefin monomer, and the haloalkanes is (3-6):(2-4):(0.5-1.2):(1-1.5).

[0020] More preferably, the molar ratio of the first monomer, the hydroxyl-containing ester monomer, the hydrophilic alkene monomer, and the haloalkanes is (4-6):(2-4):(0.7-1.0):(1-1.3).

[0021] More preferably, the molar ratio of the first monomer, the hydroxyl-containing ester monomer, the hydrophilic olefin monomer, and the haloalkanes is 5:3:0.8:1.2.

[0022] In this application, the first monomer, the hydroxyl-containing ester monomer, the hydrophilic olefin monomer, and the halogenated hydrocarbon react to obtain a prepolymer containing a quaternary ammonium salt structure. Theoretically, the higher the content of hydroxyethyl methacrylate, the more carbon atoms in the alkyl chain introduced into the quaternary ammonium salt prepolymer, and the better the antibacterial effect. However, in this application, an excessively high content of hydroxyethyl methacrylate will lead to a poorer antibacterial effect. At this time, the molecular weight of the synthesized prepolymer is too high, the relative molecular weight of the prepolymer increases, the molecule becomes larger, and the resistance to diffusion through the cell wall also increases, making it difficult to penetrate the bacterial cell membrane, resulting in a decrease in antibacterial activity. This application limits the molar ratio between the four to (3-6):(2-4):(0.5-1.2):(1-1.5) to ensure the antibacterial activity of the coating. In addition, the main component of natural rubber gloves is polyisoprene. This application selects a first monomer, a hydroxyl-containing ester monomer, a hydrophilic olefin monomer, and a halogenated hydrocarbon. The four react to obtain a prepolymer containing a quaternary ammonium salt structure. The polarity of the prepolymer is similar to that of polyisoprene, which enhances the van der Waals forces between the two and further improves the adhesion between the natural rubber gloves and the coating.

[0023] Preferably, the antibacterial solution is prepared by reacting the first monomer, the hydrophilic olefin monomer and the hydroxyl-containing ester monomer at 60-90°C, then adding the initiator, continuing the reaction for 0.8-1.5 hours, and cooling to obtain the solution.

[0024] More preferably, the method for preparing the antibacterial solution is as follows: first, the first monomer, the hydrophilic olefin monomer and the hydroxyl-containing ester monomer are reacted at 70-90℃, then an initiator is added, and the reaction is continued for 0.8-1.2h. After cooling, the solution is obtained.

[0025] More preferably, the method for preparing the antibacterial solution is as follows: first, the first monomer, the hydrophilic olefin monomer and the hydroxyl-containing ester monomer are reacted at 80°C, then an initiator is added, the reaction is continued for 1 hour, and the solution is obtained after cooling.

[0026] Preferably, the halohydrocarbon is a dihalohexane.

[0027] More preferably, the dihalohexane includes at least one selected from 1,6-difluorohexane, 1,6-dichlorohexane, 1,6-dibromohexane, and 1,6-diiodohexane.

[0028] More preferably, the dihalohexane is 1,6-dibromohexane.

[0029] Preferably, the electromagnetic wave is a gamma ray.

[0030] Preferably, the radiation dose of the γ-rays is 10-20 kGy, and the radiation time is 10-20 s.

[0031] More preferably, the radiation dose of the γ-rays is 10-14 kGy, and the radiation time is 10-18 s.

[0032] More preferably, the radiation dose of the γ-rays is 13 kGy, and the radiation time is 15 s.

[0033] Gloves containing carbon-carbon double bonds in existing technologies are often unsuitable for gamma ray irradiation, mainly because gamma ray irradiation causes rubber aging. This invention incorporates nano-titanium dioxide, which, under gamma ray irradiation, allows the hydroxyl groups of titanium dioxide to cross-link with the prepolymer. This enhances its radiation resistance and solves the aging problem of gloves under gamma ray irradiation. It also improves the washability of the coating. However, the nano-titanium dioxide is prone to agglomeration, leading to a decrease in washability. This application further limits the average particle size of the nano-titanium dioxide to 30-50 nm. A smaller average particle size results in higher surface energy, making it prone to agglomeration in the coating, severely affecting its washability and reducing the coating's antibacterial properties. Conversely, an excessively large average particle size prevents the nano-titanium dioxide from directly penetrating the bacterial cell wall and membrane, reducing the coating's antibacterial activity.

[0034] Furthermore, this application further specifies the radiation dose of γ-rays as 13 kGy and the radiation time as 15 s. At this time, the antibacterial liquid is cured under the irradiation of γ-rays, forming a coating on the surface of the medical device. At the same time, it avoids the situation where the energy of gamma rays is too high, which would cause the C-C, C-O, C-H bonds in the prepolymer molecular chain to break, resulting in an increase in the polarity difference between the prepolymer molecular chain and polyisoprene, and a decrease in the adhesion between the natural rubber glove and the coating. On the other hand, the energy of gamma rays is too low, which would not promote the cross-linking between titanium dioxide and the prepolymer, leading to a decrease in overall performance.

[0035] This invention also provides a method for preparing an antibacterial solution, comprising the following steps:

[0036] First, mix 4-6g of nano-titanium dioxide with 40-50mL of water to obtain a nano-titanium dioxide dispersion. Then, add the monomer and haloalkanes to the reactor by molar ratio. After heating, react for 4-6 minutes, then add 1-2g of initiator and simultaneously introduce argon gas to continue the reaction. After cooling, add 400-600mL of solvent and nano-titanium dioxide dispersion to obtain the final product.

[0037] The second aspect of the present invention provides an application of an irradiation sterilization method for medical devices, wherein the material of the medical device is selected from polyurethane, polypropylene, polyvinyl chloride, natural rubber, nitrile rubber, nylon elastomer, polytetrafluoroethylene, fluorinated ethylene-propylene copolymer or polystyrene, titanium and its alloys, zirconium and its alloys, iron and its alloys.

[0038] More preferably, the medical device is made of natural rubber or nitrile rubber.

[0039] Beneficial effects:

[0040] (1) The irradiation sterilization method for medical devices provided by this invention not only sterilizes the medical devices but also coats the outer and inner surfaces of the medical devices with an antibacterial coating through radiation cross-linking. This antibacterial coating significantly enhances the adhesion between the antibacterial coating and medical devices made of different materials, achieving an adhesion level of 0. In particular, the adhesion is even better for medical gloves made from components such as natural rubber and nitrile rubber containing unsaturated double bonds. The glove surface does not exhibit yellowing, and its mechanical properties are not damaged. This solves the aging problem of gloves under gamma ray irradiation, improves the aging resistance of the coating, and, using a specific dose of gamma rays, can achieve a gamma ray intensity of 10. -6 The sterilization and antibacterial effects are as high as 96.20%, and the antibacterial rate is still as high as 95.33% after 50 washes, proving that its water resistance is excellent.

[0041] (2) The antibacterial coating prepared by the present invention through irradiation sterilization is applied to medical devices by radiation curing. It does not contain heavy metals such as nano silver ions or toxic solvents, is environmentally friendly and harmless to the human body. Furthermore, this method can be used for large-scale industrial production, is simple to operate, saves time and effort, and the sterilized products can be stored for a long time. Example

[0042] Example 1

[0043] A method for radiation sterilization of a medical device includes the following steps: First, the medical device is ultrasonically treated in an ethanol solution, then rinsed three times with deionized water and dried to obtain a pretreated medical device. Then, the medical device is immersed in an antibacterial solution for 1 hour until the inner and outer surfaces of the medical device are coated with the antibacterial solution. After drying, it is irradiated with γ rays with a radiation dose of 13 kGy for 15 seconds.

[0044] The raw materials for synthesizing the antibacterial solution include monomers, halogenated hydrocarbons, initiators, and solvents.

[0045] The monomers are N-isopropylacrylamide, 2,4-vinylpyridine, and hydroxyethyl methacrylate; the halogenated hydrocarbon is 1,6-dibromohexane; the initiator is potassium persulfate; and the solvent is ethanol.

[0046] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane is 5:3:0.8:1.2.

[0047] The method for preparing the antibacterial solution is as follows: First, mix 5g of nano-titanium dioxide and 50mL of water to obtain a nano-titanium dioxide dispersion. Add the monomer and haloalkanes to the reactor by molar ratio. After reacting at 80℃ for 5min, add 2g of initiator and simultaneously introduce argon gas. Continue the reaction for 1h at a rotation speed of 200rpm / min. After cooling to 25℃, add 500mL of solvent and nano-titanium dioxide dispersion to prepare the antibacterial solution.

[0048] In this embodiment, the medical device is a medical glove made of natural rubber, and the nano-titanium dioxide has an average particle size of 40nm and was purchased from Aladdin.

[0049] Example 2

[0050] A method for radiation sterilization of a medical device includes the following steps: First, the medical device is ultrasonically treated in an ethanol solution, then rinsed three times with deionized water and dried to obtain a pretreated medical device. Then, the medical device is immersed in an antibacterial solution for 1 hour until the inner and outer surfaces of the medical device are coated with the antibacterial solution. After drying, it is irradiated with γ rays with a radiation dose of 14 kGy for 15 seconds.

[0051] The raw materials for synthesizing the antibacterial solution include monomers, halogenated hydrocarbons, initiators, and solvents.

[0052] The monomers are N-isopropylacrylamide, 2,4-vinylpyridine, and hydroxyethyl methacrylate; the halogenated hydrocarbon is 1,6-dibromohexane; the initiator is potassium persulfate; and the solvent is ethanol.

[0053] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane is 6:4:1.2:1.5.

[0054] The method for preparing the antibacterial solution is as follows: First, mix 5g of nano-titanium dioxide and 50mL of water to obtain a nano-titanium dioxide dispersion. Add the monomer and haloalkanes to the reactor by molar ratio. After reacting at 80℃ for 5min, add 2g of initiator and simultaneously introduce argon gas. Continue the reaction for 1.5h at a rotation speed of 200rpm / min. After cooling to 25℃, add 500mL of solvent and nano-titanium dioxide dispersion to prepare the antibacterial solution.

[0055] In this embodiment, the medical device is a medical glove made of natural rubber, and the nano-titanium dioxide has an average particle size of 40nm and was purchased from Aladdin.

[0056] Example 3

[0057] A method for radiation sterilization of a medical device includes the following steps: First, the medical device is ultrasonically treated in an ethanol solution, then rinsed three times with deionized water and dried to obtain a pretreated medical device. Then, the medical device is immersed in an antibacterial solution for 1 hour until the inner and outer surfaces of the medical device are coated with the antibacterial solution. After drying, it is irradiated with γ rays with a radiation dose of 10 kGy for 15 seconds.

[0058] The raw materials for synthesizing the antibacterial solution include monomers, halogenated hydrocarbons, initiators, and solvents.

[0059] The monomers are N-isopropylacrylamide, 2,4-vinylpyridine, and hydroxyethyl methacrylate; the halogenated hydrocarbon is 1,6-dibromohexane; the initiator is potassium persulfate; and the solvent is ethanol.

[0060] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane is 3:2:0.5:1.0.

[0061] The method for preparing the antibacterial solution is as follows: First, mix 5g of nano-titanium dioxide and 50mL of water to obtain a nano-titanium dioxide dispersion. Add the monomer and haloalkanes to the reactor by molar ratio. After reacting at 80℃ for 5min, add the initiator and simultaneously introduce argon gas. Continue the reaction for 0.8h at a rotation speed of 200rpm / min. After cooling to 25℃, add 500mL of solvent and nano-titanium dioxide dispersion to prepare the antibacterial solution.

[0062] In this embodiment, the medical device is a medical glove made of natural rubber, and the nano-titanium dioxide has an average particle size of 40nm and was purchased from Aladdin.

[0063] Comparative Example 1

[0064] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane was changed to 5:5:0.8:1.5, and the rest was the same as in Example 1.

[0065] Comparative Example 2

[0066] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane was changed to 5:1:1.5:1.0, and the rest was the same as in Example 1.

[0067] Comparative Example 3

[0068] A method for radiation sterilization of a medical device includes the following steps: First, the medical device is ultrasonically treated in an ethanol solution, then rinsed three times with deionized water and dried to obtain a pretreated medical device. Then, the medical device is immersed in an antibacterial solution for 1 hour until the inner and outer surfaces of the medical device are coated with the antibacterial solution. After drying, it is irradiated with γ rays with a radiation dose of 13 kGy for 15 seconds.

[0069] The raw materials for synthesizing the antibacterial solution include monomers, halogenated hydrocarbons, initiators, and solvents.

[0070] The monomers are N-isopropylacrylamide, 2,4-vinylpyridine, and hydroxyethyl methacrylate; the halogenated hydrocarbon is 1,6-dibromohexane; the initiator is potassium persulfate; and the solvent is ethanol.

[0071] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane is 5:3:0.8:1.2.

[0072] The method for preparing the antibacterial solution is as follows: add the monomer and haloalkanes to the reactor in molar ratio, react at 80°C for 5 min, then add 2g of initiator, and simultaneously introduce argon gas. Continue the reaction for 1 h at a rotation speed of 200 rpm / min. After cooling to 25°C, add 500mL of solvent to prepare a dispersion.

[0073] In this embodiment, the medical device is a medical glove made of natural rubber.

[0074] Comparative Example 4

[0075] A method for radiation sterilization of a medical device includes the following steps: First, the medical device is ultrasonically treated in an ethanol solution, then rinsed three times with deionized water and dried to obtain a pretreated medical device. Then, the medical device is immersed in an antibacterial solution for 1 hour until the inner and outer surfaces of the medical device are coated with the antibacterial solution. After drying, it is irradiated with γ rays with a radiation dose of 13 kGy for 15 seconds.

[0076] The raw materials for synthesizing the antibacterial solution include monomers, halogenated hydrocarbons, initiators, and solvents.

[0077] The monomers are N-isopropylacrylamide, 2,4-vinylpyridine, and hydroxyethyl methacrylate; the halogenated hydrocarbon is 1,6-dibromohexane; the initiator is potassium persulfate; and the solvent is ethanol.

[0078] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane is 5:3:0.8:1.2.

[0079] The method for preparing the antibacterial solution is as follows: First, mix 5g of nano-titanium dioxide and 50mL of water to obtain a nano-titanium dioxide dispersion. Add the monomer and haloalkanes to the reactor by molar ratio. After reacting at 80℃ for 5min, add 2g of initiator and simultaneously introduce argon gas. Continue the reaction for 1h at a rotation speed of 200rpm / min. After cooling to 25℃, add 500mL of solvent and nano-titanium dioxide dispersion to prepare the antibacterial solution.

[0080] In this embodiment, the medical device is a medical glove made of natural rubber. The nano-titanium dioxide has an average particle size of 15nm and was purchased from Ningbo Jiwei Nano New Materials Technology Co., Ltd., model number JWN-R15.

[0081] Comparative Example 5

[0082] A method for radiation sterilization of a medical device includes the following steps: First, the medical device is ultrasonically treated in an ethanol solution, then rinsed three times with deionized water and dried to obtain a pretreated medical device. Then, the medical device is immersed in an antibacterial solution for 1 hour until the inner and outer surfaces of the medical device are coated with the antibacterial solution. After drying, it is irradiated with γ rays with a radiation dose of 25 kGy for 14 seconds.

[0083] The raw materials for synthesizing the antibacterial solution include monomers, halogenated hydrocarbons, initiators, and solvents.

[0084] The monomers are N-isopropylacrylamide, 2,4-vinylpyridine, and hydroxyethyl methacrylate; the halogenated hydrocarbon is 1,6-dibromohexane; the initiator is potassium persulfate; and the solvent is ethanol.

[0085] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane is 5:3:0.8:1.2.

[0086] The method for preparing the antibacterial solution is as follows: First, mix 5g of nano-titanium dioxide and 50mL of water to obtain a nano-titanium dioxide dispersion. Add the monomer and haloalkanes to the reactor by molar ratio. After reacting at 80℃ for 5min, add the initiator and simultaneously introduce argon gas. Continue the reaction for 1h at a rotation speed of 200rpm / min. After cooling to 25℃, add 500mL of solvent and nano-titanium dioxide dispersion to prepare the antibacterial solution.

[0087] In this comparative example, the medical device is a medical glove made of natural rubber, and the average particle size of the nano-titanium dioxide is 40nm, purchased from Aladdin.

[0088] Comparative Example 6

[0089] A method for radiation sterilization of a medical device includes the following steps: First, the medical device is ultrasonically treated in an ethanol solution, then rinsed three times with deionized water and dried to obtain a pretreated medical device. Then, the medical device is immersed in an antibacterial solution for 1 hour until the inner and outer surfaces of the medical device are coated with the antibacterial solution. After drying, it is irradiated with γ rays with a radiation dose of 5 kGy for 17 seconds.

[0090] The raw materials for synthesizing the antibacterial solution include monomers, halogenated hydrocarbons, initiators, and solvents.

[0091] The monomers are N-isopropylacrylamide, 2,4-vinylpyridine, and hydroxyethyl methacrylate; the halogenated hydrocarbon is 1,6-dibromohexane; the initiator is potassium persulfate; and the solvent is ethanol.

[0092] The molar ratio of N-isopropylacrylamide, hydroxyethyl methacrylate, 2,4-vinylpyridine, and 1,6-dibromohexane is 5:3:0.8:1.2.

[0093] The method for preparing the antibacterial solution is as follows: First, mix 5g of nano-titanium dioxide and 50mL of water to obtain a nano-titanium dioxide dispersion. Add the monomer and haloalkanes to the reactor by molar ratio. After reacting at 80℃ for 5min, add the initiator and simultaneously introduce argon gas. Continue the reaction for 1h at a rotation speed of 200rpm / min. After cooling to 25℃, add 500mL of solvent and nano-titanium dioxide dispersion to prepare the antibacterial solution.

[0094] In the comparative example, the medical device was a medical glove made of natural rubber, and the nano-titanium dioxide had an average particle size of 40 nm and was purchased from Aladdin.

[0095] Performance Evaluation

[0096] (1) Antibacterial rate test: The antibacterial rate of the examples and comparative examples was tested according to the test standard QB / T2591-2003. The test results are shown in Table 1.

[0097] (2) Water resistance test: The antibacterial rate of the coated natural rubber gloves was measured after 50 washes.

[0098] (3) Adhesion test: Rub the coated natural rubber glove 20 times under a friction pressure of 0.1 MPa and observe the adhesion. If the coating does not fall off, it is qualified; if it falls off, it is unqualified.

[0099] (4) Aging resistance test: The tensile strength of the medical gloves before aging was 23.4 MPa, according to the test standard GB / T528-2009.

[0100] Table 1

[0101]

[0102]

[0103] Compared to Example 1, the excessively high content of hydroxyethyl methacrylate in Comparative Example 1 resulted in an excessively high molecular weight of the synthesized prepolymer, leading to excessive resistance to penetration of bacterial cell membranes and reduced antibacterial activity of the coating, although adhesion was not affected. In Comparative Example 2, the low content of hydroxyethyl methacrylate resulted in a low content of unsaturated bonds in the generated prepolymer, and the low carbon number of the alkyl chain in the introduced quaternary ammonium salt prepolymer also led to a corresponding decrease in the antibacterial activity of the coating. In Comparative Example 3, the absence of nano-titanium dioxide reduced antibacterial activity and also compromised the coating's aging resistance. The effects will be correspondingly weakened. In Comparative Example 4, the average particle size of the nano-titanium dioxide is small, which will cause the nano-titanium dioxide in the coating to agglomerate, seriously affecting its water washability. The antibacterial properties of the coating will also decrease accordingly. In Comparative Example 5, the increased radiation dose of γ-rays may cause some of the C-C bonds in the quaternary ammonium salt prepolymer to break, which will instead cause a decrease in its adhesion and antibacterial properties. In Comparative Example 6, the energy of γ-rays is too low, the density of the cross-linked network in the system decreases, the adhesion performance decreases significantly, and the nano-titanium dioxide does not cross-link well with the coating, resulting in a significant decrease in water washability.

Claims

1. A method of irradiation sterilization of a medical device, characterized in that, The method comprises the following steps: First, the medical device is pretreated, then the pretreated medical device is immersed in the bacteriostatic solution and dried, and then sterilized under electromagnetic waves, wherein the electromagnetic waves are gamma rays; The synthesis raw materials of the bacteriostatic solution comprise monomers, dihalogenated hexane, an initiator, and a solvent; The monomers include a first monomer, a hydrophilic olefin monomer, and a hydroxyl-containing ester monomer; the first monomer includes N, N' Methylenebisacrylamide, N Isopropylacrylamide, N,N Dimethacrylamide, N,N At least one of diethylacrylamide, the hydrophilic olefin monomer including N Hydroxymethylacrylamide, N Hydroxyethylacrylamide, N (2 Hydroxypropyl (Hydroxypropyl) Methacrylamide, N (2 Hydroxyethyl) 2 methyl 2 Acrylamide, 2,4 At least one of vinylpyridine; The bacteriostatic solution further comprises nano titanium dioxide; The molar ratio of the first monomer, the hydroxyl-containing ester monomer, the hydrophilic olefin monomer, and the dihalogenated hexane is (3-6):(2-4):(0.5-1.2):(1-1.5); The preparation method of the bacteriostatic solution is as follows: the first monomer, the hydrophilic olefin monomer, and the hydroxyl-containing ester monomer are reacted at 60-90 ℃, then the initiator is added, and the reaction is continued for 0.8-1.5 h, and then the bacteriostatic solution is obtained after cooling; The radiation dose of the gamma rays is 10-20 kGy, and the radiation time is 10-20 s.

2. Application of the irradiation sterilization method according to claim 1 to a medical device, wherein the medical device is made of polyurethane, polypropylene, polyvinyl chloride, natural rubber, nitrile rubber, nylon elastomer, polytetrafluoroethylene, fluorinated ethylene-propylene copolymer, or polystyrene, titanium and its alloys, zirconium and its alloys, or iron and its alloys.

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