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Biocidal treatment method for medical device carrying gene coating

A technology of sterilization treatment and medical devices, which is applied in the field of medical devices, can solve the problems of damage and difficult application, and achieve the effects of expanding blood volume, promoting hematopoiesis and detoxification, and excellent sterilization effect

Active Publication Date: 2009-07-22
LEPU MEDICAL TECH (BEIJING) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Therefore, Co60-γ-ray irradiation disinfection has gradually replaced the conventional chemical disinfection method, but Co60-γ-ray irradiation disinfection also has disadvantages. The oxygen free radicals generated by ionization during the irradiation process are harmful to biologically active components such as genes or Oligonucleotides have a greater destructive effect, so it is difficult to apply to medical devices carrying genetic coatings

Method used

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  • Biocidal treatment method for medical device carrying gene coating
  • Biocidal treatment method for medical device carrying gene coating

Examples

Experimental program
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Effect test

Embodiment 1

[0036] Example 1 Preparation of iNOS gene-coated stent

[0037]The 316L stainless steel alloy material is polished and then engraved into a vascular stent with a laser. The surface of the stent is processed by chemical or physical methods, such as corrosion, anodic oxidation, micro-arc oxidation, micro-arc nitriding, etc., or a combination of these methods on the raw material of the device body. The local surface is directly prepared to form holes, which can be drug-loading grooves or pore structures, and the diameter of the holes is 200-300nm (see patent 200610168125.0 for the specific method of hole preparation). The iNOS gene-coated bioscaffold was prepared according to the following steps:

[0038] 1. Cleaning of the surface of the bracket body:

[0039] (1) Grinding the surface of the bracket body with an abrasive belt, mechanically removing oxides on the surface, and adjusting the surface roughness;

[0040] (2) Use ultrasonic waves to clean with 75% medical ethanol so...

Embodiment 2

[0050] Example 2 Sterilization of iNOS gene-coated stents

[0051] Sodium ascorbate was dissolved in distilled water to obtain an ascorbate solution with a concentration of 20 mg / ml; the ascorbate solution was evenly sprayed on the surface of the iNOS gene-coated stent in Example 1, and the thickness of the sterilization protective coating was about 5 μm ; Pre-freeze the stent coated with the iNOS gene protective coating in the refrigerator for 2 hours, then put it in a vacuum freeze dryer with a vacuum degree of <10 Pa and a cold 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 a temperature of 25° C., a dose of 15 KGy, and a humidity of 35%.

Embodiment 3

[0052] Example 3 Sterilization of iNOS gene-coated stents

[0053] Dextran 40 was dissolved in distilled water to obtain a dextran 40 solution with a concentration of 40 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 10 μm ; Pre-freeze the stent coated with the iNOS gene protective coating in the refrigerator for 2 hours, then put it in a vacuum freeze dryer with a vacuum degree of <10 Pa and a cold temperature of -55°C for 10 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 10°C, dose 5KGy, and humidity 10%.

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Abstract

The invention relates to a sterilization treatment method for a medical device coated with a genetic coating. The sterilization treatment method is to coat a bioactive protective coating on the genetic coating on the surface of the medical device, perform freeze-drying treatment, and adopt Co60-gamma rays for irradiation and sterilization. The sterilization treatment method adopts the bioactive protective coating, and avoids damage caused by irradiation of the Co60-gamma rays on the activity of genes when simultaneously guaranteeing the sterilization effect; and the prepared medical device coated with the genetic coating has high gene trasnfectcion efficiency so as to effectively give play to the advantages of promoting endothelial repair and inhibiting proliferation of smooth muscles in a specified physiological environment.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a sterilization method suitable for medical devices carrying gene coatings. Background technique [0002] An ideal implantable medical device should not only have good biocompatibility, but also promote healing of injured tissue, prevent excessive cell proliferation, accelerate endothelialization of luminal tissue, and prevent thrombosis and restenosis. With the development of molecular biology, the pathogenesis of many diseases has been elucidated at the gene level, which makes it possible to diagnose and cure diseases at the gene level. The therapeutic methods of gene transfer and regulation in the treatment of heart disease, tumors, diabetes, etc. are becoming research hotspots. For example, genes that promote endothelial repair and inhibit intima proliferation are introduced into the cardiovascular system and expressed in the blood vessels, thereby achieving the purpose of inh...

Claims

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Application Information

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IPC IPC(8): A61L2/08
Inventor 陈永强蒲忠杰
Owner LEPU MEDICAL TECH (BEIJING) CO LTD
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