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Biocidal treatment method for biological coating medical device

A medical device and sterilization treatment technology, which is applied in the direction of irradiation, etc., can solve the problems of biological active ingredients, biological antibody activity destruction, etc., and achieve excellent sterilization effect, safe use, and simple process

Active Publication Date: 2009-02-18
乐普(深圳)国际发展中心有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, Co60-γ-ray irradiation disinfection also has certain defects. The oxygen free radicals generated by ionization during the irradiation process have a greater destructive effect on biologically active components such as biological antibody activity.

Method used

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  • Biocidal treatment method for biological coating medical device
  • Biocidal treatment method for biological coating medical device
  • Biocidal treatment method for biological coating medical device

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The preparation of embodiment 1 biocoating medical device

[0038] After polishing, 316 stainless steel alloy or cobalt complex alloy material was used to engrave a vascular stent with a laser, and the monoclonal antibody CD34-coated biological stent was prepared according to the following steps:

[0039] 1. Cleaning of the surface of the bracket body:

[0040] (1) Grinding the surface of the bracket body with an abrasive belt, mechanically removing oxides on the surface, and adjusting the surface roughness;

[0041] (2) Use ultrasonic waves to clean with 75% medical ethanol solution, 99.5% acetone solution, and deionized water in sequence. The ultrasonic frequency is 100KHz, and the cleaning time is 10 minutes;

[0042] (3) Soak the stent body in a 30g / L, 80°C sodium hydroxide solution for 10 minutes to remove grease and scale;

[0043] (4) Place the cleaned stent body in a vacuum dryer, set the temperature at 40° C., and take it out after drying for 45 minutes.

[...

Embodiment 2

[0050] Example 2 Sterilization of biocoated medical devices

[0051] Ascorbate is dissolved in distilled water to obtain an ascorbate solution with a concentration of 20 mg / ml; the ascorbate solution is evenly sprayed on the surface of the biological antibody-coated medical device in Example 1, and the thickness of the sterilization protective coating is about 5 μm ; After pre-freezing the medical device coated with the antibody active protective coating in the refrigerator for 2 hours, put it in a vacuum freeze dryer with a vacuum degree of <10pa and a cold temperature of -55°C for 4 hours, take it out and put it in -20 Store in a ℃ freezer. The packaged medical device is sterilized by Co60-γ-ray irradiation under the conditions of a temperature of 25° C., a dose of 15 KGy, and a humidity of 35%.

Embodiment 3

[0052] The sterilization treatment of embodiment 3 biological coating medical devices

[0053] Dextran 40 was dissolved in distilled water to prepare a dextran 40 solution with a concentration of 20 mg / ml; the dextran 40 solution was evenly sprayed on the surface of the biological antibody-coated medical device in Example 1, and the thickness of the sterilization protective coating was about 5 μm ; After pre-freezing the medical device coated with the antibody active protective coating in the refrigerator for 2 hours, put it in a vacuum freeze dryer with a vacuum degree of <10 Pa and a cooling temperature of -55°C for 4 hours, take it out and put it in -20°C Store in the freezer. The packaged medical device is sterilized by Co60-γ-ray irradiation under the conditions of temperature 25°C, dose 12KGy, and humidity 55%.

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Abstract

The invention relates to a sterilization treatment method for a biological coating medical device, wherein a biological activity protective coating is coated outside a biological coating on the surface of the medical device, is subjected to freeze-drying treatment and is sterilized by the radiation of Co60-gamma rays. The germicidal treatment method provided by the invention adopts the biologicalactivity protective coating, and can avoid the radiation of Co60-gamma rays from damaging biological activity compositions while ensuring the sterilization effect; moreover, the method also has the advantages of simple process, safe use and high industrial practicability.

Description

technical field [0001] The invention relates to a sterilizing treatment method, in particular to a sterilizing treatment method for a bio-coated medical device without destroying biological activity. Background technique [0002] Coating a layer of bioactive coating on the surface of medical devices can regulate vasomotion, prevent platelet adhesion and thrombosis, regulate the growth and proliferation of vascular smooth muscle, and reduce the body's rejection of implanted medical devices. play a significant role. Studies have shown that some antibodies can significantly promote vascular endothelialization and inhibit thrombosis, growth and proliferation of vascular smooth muscle. [0003] Since biomedical devices contain biologically active components, their sterilization methods must overcome the problems of high temperature, strong free radicals, radiation, etc. that destroy biologically active structures. [0004] At present, disposable medical supplies and medical pac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/08
Inventor 陈永强余占江张正才蒲忠杰王玲王长青
Owner 乐普(深圳)国际发展中心有限公司
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