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Complete degradable absorbent medicine slow-release magnesium alloy bracket and use thereof

A magnesium alloy stent, complete degradation technology, applied in the field of drug slow-release magnesium alloy stent, can solve the problems that affect the implantation effect, no visibility, poor degradation controllability, etc., to reduce restenosis rate and thrombosis, Easy to observe and monitor, slow down the effect of complications

Active Publication Date: 2009-03-18
北京金信科创生物技术有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, degradable polymer materials have the following problems: (1) low strength, low hardness and rigidity, in order to improve the strength, the size of the wire diameter of the stent needs to be increased, which will affect the implantation effect; (2) the degradation controllability is poor, and the degradation time and The strength and rigidity of the material are not proportional, and it is easy to lose strength prematurely during the degradation process, resulting in early failure of the device; (3) The processing stability is poor, and the processing of degraded polymer materials requires special processing environments and equipment
In China, the Institute of Metal Research, Chinese Academy of Sciences took the lead in carrying out research on degradable magnesium alloys. The applicant of the present invention has applied for a patent "Controlled Degradation Biomedical Metal Implant Materials and Its Application" (Patent No.: 200510046360.6) and a utility model patent "Absorbable metal magnesium implant stent" (patent number: 200620091360.8), but in the later research and application, it was found that due to the low density of magnesium alloy, there is almost no visibility under X-ray during the implantation process, which is not convenient for surgical operation and postoperative observation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] AZ31B magnesium alloy was used to make a stent sample (after polishing, the average wire diameter was 150 μm ± 5 μm), ultrasonically cleaned in acetone and alcohol for 5 minutes, and a 4 μm thick platinum layer was formed on both ends of the stent by chemical vapor deposition. °C, pH=8, 5% mass concentration of disodium hydrogen phosphate solution for 5 hours to obtain a phosphate surface layer of 4 μm on the surface of the stent.

[0028] After drying, put the scaffold into 10% collagen aqueous solution (containing 0.1% paclitaxel in mass concentration), soak for 20 minutes, and quickly pull up the scaffold. You can increase the number of soaking times to increase the thickness of the surface layer, and centrifuge at 500rpm Treat for 1 minute, then put it in a vacuum drying oven at 90° C. for 30 minutes, and cool to room temperature with the furnace. The total thickness of the surface layer in this embodiment is 10 μm.

Embodiment 2

[0030]Use ZK60 magnesium alloy to make a stent sample (after polishing, the average wire diameter is 120 μm ± 5 μm), ultrasonically clean it in acetone and alcohol for 5 minutes, and use ion plating to form a 5 μm thick tantalum layer on both ends of the magnesium alloy stent. Soak in a mixed solution of 5% sodium dihydrogen phosphate and 3% sodium phosphate at a pH of 8.4 at 70°C for 3 hours to obtain a phosphate surface layer of 5 μm on the surface of the scaffold.

[0031] After drying, put the stent in the spraying device, use a spray gun to spray the prepared colloid of 5% gelatin (containing 0.05% rapamycin and 0.5% developer) onto the inner and outer surfaces of the stent several times, and finally The stent was dried in a vacuum oven at 60° C. for 12 hours, and the total thickness of the surface layer in this embodiment was 12 μm.

Embodiment 3

[0033] AE21 magnesium alloy was used to make a stent sample (after polishing, the average wire diameter was 160 μm ± 5 μm), ultrasonically cleaned in acetone and alcohol for 5 minutes, and a 5 μm thick tantalum layer was formed on both ends of the magnesium alloy stent by ion implantation. Soak in a mixed solution of 3% sodium dihydrogen phosphate, 3% sodium phosphate and 2% disodium hydrogen phosphate for 4 hours at 80°C, pH=7.8, to obtain a phosphate surface layer of 5 μm on the surface of the scaffold.

[0034] After drying, the stent was placed in the spraying device, and the colloid containing the drug in tetrahydrofuran (with a mass concentration of 0.08% heparin) prepared with a mass concentration of 3% polyglycolic acid was sprayed onto the inner and outer surfaces of the stent several times with a spray gun, and finally the stent was placed. Dry in a vacuum oven at 50°C for 20 hours, and the total thickness of the surface layer in this example is 15 μm.

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Abstract

The invention relates to the technical field of medical apparatus, in particular to a drug-release magnesium alloy stent which can be completely degraded and adsorbed, with the period of drug release being about 30 days. The stent is obtained from a magnesium alloy precise tube that is cut through laser; the surface of the stent has a double-layer coating structure, with the inner layer being a temporarily protective layer of a magnesium alloy substrate and the outer layer a degradable polymer film which is mixed with drugs. In addition, the stent is visual in X-ray by means of marks at both sides or on the surface. The drug-release magnesium alloy stent is not only provided with good mechanical property, but also good visibility in X-ray, and can, by the option of slow-release drugs, reduce the restenosis occurrence after being implanted. In addition, the stent can be gradually degraded in and adsorbed by a biosome and used as a stent in a cardiovascular system or other cavities.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a drug slow-release magnesium alloy stent that can be completely degraded and absorbed. Background technique [0002] With the development of modern medical technology and the improvement of medical equipment, coronary artery stent implantation has gradually become a major means of interventional cardiovascular therapy. At present, there are more than 25 million patients with coronary heart disease in my country, and they are in a period of rapid growth. With the aging population, changes in diet structure and accelerated pace of life, the incidence of coronary heart disease in my country will continue to increase. Therefore, it can be predicted that my country is the most potential coronary stent market. [0003] At present, implanted stents used in medicine are mainly processed and manufactured by various methods of medical metal materials such as stainless steel and ...

Claims

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Application Information

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IPC IPC(8): A61L31/16A61L31/08A61L31/02A61F2/82
Inventor 任伊宾杨柯张炳春郑丰肖克沈
Owner 北京金信科创生物技术有限责任公司
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