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A coating process for drug coating on implanted or interventional medical devices

A medical device and drug coating technology, applied in coatings, medical science, medical containers, etc., can solve problems such as blood vessel blockage and safety concerns, and achieve the effect of avoiding blood vessel blockage, thrombus formation, and small coating shedding

Active Publication Date: 2016-05-18
ZHEJIANG BELONGS TO A MEDICAL INSTR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Drug-coated balloons and drug-eluting stents prepared by ultrasonic spraying process have more opportunities to form large-particle drug aggregates on the surface. Such aggregates may block blood vessels during actual use, and their safety has been questioned.

Method used

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  • A coating process for drug coating on implanted or interventional medical devices
  • A coating process for drug coating on implanted or interventional medical devices
  • A coating process for drug coating on implanted or interventional medical devices

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Embodiment 1: Preparation method of paclitaxel drug-coated balloon

[0040] 1) Preparation of spraying solution: Weigh about 0.15g of paclitaxel and 0.3g of PVP into a 25ml glass bottle; add 10ml of acetonitrile into the glass bottle; keep warm in an oven at 45°C until paclitaxel and PVP are completely dissolved.

[0041]2) Preparation of carrier gas: pass dry high-purity nitrogen through 95% (volume) ethanol / water mixed solution, install a 0.25μm filter membrane at the outlet of the pipeline, and filter fine droplets;

[0042] 3) Balloon coating: place a 4.0mm*60mm balloon under the ultrasonic spray head, set the ultrasonic frequency to 30khz, the flow rate of the spray solution to 0.1ml / min, the rotation speed of the balloon to 5r / s, and the spraying time For 2min, the carrier gas flow rate is: 30L / h. After spraying, remove the balloon.

[0043] 4) The balloon was dried at room temperature for 30 minutes.

[0044] 5) Fold the balloon, put it into the coil, pack and...

Embodiment 2

[0046] Embodiment 2: Preparation method of rapamycin drug-coated balloon

[0047] 1) Preparation of spraying solution: weigh about 0.13g rapamycin and 0.3g PVA, add to a 25ml glass bottle; add 10ml of ethanol to the glass bottle, stir to dissolve the drug completely.

[0048] 2) Preparation of carrier gas: pass dry air through 75% (volume) acetonitrile / water mixed solvent, and install a 0.25 μm filter membrane at the outlet of the pipeline to filter fine droplets;

[0049] 3) Balloon coating: place a 4.0mm*60mm balloon under the ultrasonic spray head, set the ultrasonic frequency to 50khz, the flow rate of the spray solution to 0.2ml / min, the rotation speed of the balloon to 10r / s, and the spraying time 1.5min, carrier gas flow rate: 30L / h. After spraying, remove the balloon.

[0050] 4) The balloon was dried at room temperature for 30 minutes.

[0051] 5) Fold the balloon, put it into the coil, pack and sterilize.

Embodiment 3

[0052] Embodiment 3: Preparation method of rapamycin drug-coated balloon

[0053] 1) Preparation of spraying solution: Weigh about 0.25g rapamycin and 0.25g PEG into a 25ml glass bottle; add 10ml methanol into the glass bottle and stir to dissolve the drug completely.

[0054] 2) Preparation of carrier gas: pass dry oxygen through water for injection, and install a 0.25μm filter membrane at the outlet of the pipeline to filter fine droplets;

[0055] 3) Balloon coating: place a 4.0mm*60mm balloon under the ultrasonic spray head, set the ultrasonic frequency to 45khz, the flow rate of the spray solution to 0.18ml / min, the balloon rotation speed to 4r / s, and the spraying time 1.2min, carrier gas flow rate: 25L / h. After spraying, remove the balloon.

[0056] 4) The balloon is vacuum dried at 30°C for 20 minutes.

[0057] 5) Fold the balloon, put it into the coil, pack and sterilize.

[0058] Balloon coating performance test:

[0059] 1. Test method and result of drug coating...

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Abstract

The invention relates to the technical field of medical device preparation, in particular to a coating process of a drug coating on an implanted or interventional medical device. In this process, ultrasonic spraying is used to form a coating on the medical device. During the ultrasonic spraying process, the carrier gas is modified so that one or more auxiliary solvent gases that cannot dissolve the drug are introduced into the carrier gas. After the drug droplets meet the carrier gas, the drug is precipitated in the form of particles due to the change of solubility, so as to achieve the purpose of reducing the particle size of the final drug coating. The drug coating formed by this process is uniform, has good affinity with the surface of the stent or the balloon, the coating falls off little when it is folded and pressed, and does not form large drug crystal particles after being immersed in blood.

Description

technical field [0001] The invention relates to the technical field of medical device preparation, in particular to a coating process of a drug coating on an implanted or interventional medical device. Background technique [0002] With the widespread application of endovascular intervention or implantation, the subsequent postoperative vascular restenosis has attracted more and more attention. Studies have shown that there are different factors that cause intravascular restenosis, such as vascular intimal injury, thrombosis, inflammation, healing, genes, etc., but the currently recognized formation mechanisms include elastic recoil of the vessel wall after vasodilation and thrombosis. , the hyperproliferation and migration of vascular smooth muscle cells (VSMC) induced by injury to the intima play a key role. In recent years, a variety of interventional or implantable medical devices containing drug coatings have been developed for various mechanisms of intravascular reste...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/16A61L31/10A61L29/16A61L29/08A61L33/00
Inventor 常婷季培红颜玉强赵中
Owner ZHEJIANG BELONGS TO A MEDICAL INSTR
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