Medicine coated balloon and preparation method thereof

A drug and balloon technology, applied in the field of medical devices, can solve problems such as high cost, limited application, and complex composition of drug coating raw materials

Active Publication Date: 2016-12-21
DK MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, for the drug-coated balloon catheter, the raw material composition of the drug coating is complex and the cost is high, which limits its application

Method used

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  • Medicine coated balloon and preparation method thereof
  • Medicine coated balloon and preparation method thereof
  • Medicine coated balloon and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] The drug-coated balloon of this embodiment includes a drug balloon and a coating of the drug balloon;

[0094] The raw materials of the coating of the drug balloon are: paclitaxel 8g, iopromide 2g, ethanol 5g;

[0095] The preparation method of the coating of this medicine balloon is:

[0096] (1) Take paclitaxel, iopromide and ethanol of selected weight, mix evenly, heat to 30°C, stir at constant temperature for 30min, obtain coating solution, set aside;

[0097] (2) Inflate the drug balloon to an internal pressure of 2 atm, then fold the drug balloon into three wings at 45°C for 120s;

[0098] (3) Inject the coating solution into the coating machine, adjust the power of the ultrasonic device of the coating machine to be 20W, and the drug balloon moves linearly and axially at 2 mm / s, and simultaneously at 3 revolutions / s The circular axial movement sprays the atomized coating solution on the surface of the drug balloon to obtain the coating of the drug balloon.

[0...

Embodiment 2

[0101] The drug-coated balloon of this embodiment includes a drug balloon and a coating of the drug balloon;

[0102] The raw materials of the coating of the drug balloon are: paclitaxel 8.5g, iopromide 1.5g, ethanol 10g;

[0103] The preparation method of the coating of this medicine balloon is:

[0104] (1) Take paclitaxel, iopromide and ethanol of the selected weight, mix evenly, heat to 20°C, stir at constant temperature for 40min to obtain a coating solution, and set aside;

[0105] (2) Inflate the drug balloon to an internal pressure of 1 atm, then fold the drug balloon into three wings at 70°C for 300 seconds;

[0106] (3) Inject the coating solution into the coating machine, adjust the power of the ultrasonic device of the coating machine to be 10W, and the drug balloon moves linearly and axially at 4 mm / s, and simultaneously at 6 revolutions / s The circular axial movement sprays the atomized coating solution on the surface of the drug balloon to obtain the coating of...

Embodiment 3

[0109] The drug-coated balloon of this embodiment includes a drug balloon and a coating of the drug balloon;

[0110] The raw materials of the coating of the drug balloon are: paclitaxel 9g, iopromide 1g, ethanol 3g;

[0111] The preparation method of the coating of this medicine balloon is:

[0112] (1) Take paclitaxel, iopromide and ethanol of selected weight, mix evenly, heat to 40°C, stir at constant temperature for 20min, obtain coating solution, set aside;

[0113] (2) Inflate the drug balloon to an internal pressure of 4 atm, then fold the drug balloon into 6 wings at 30°C for 10 seconds;

[0114] (3) Inject the coating solution into the coating machine, adjust the power of the ultrasonic device of the coating machine to be 30W, and the drug balloon moves linearly and axially at 1mm / sec, and simultaneously at 10 rpm / sec. The circular axial movement sprays the atomized coating solution on the surface of the drug balloon to obtain the coating of the drug balloon.

[01...

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Abstract

The invention relates to a medicine coated balloon and a preparation method thereof. The coating is prepared from the following raw materials in parts by weight: 5-9 parts of a medicine, 1-5 parts of excipient and 1-15 parts of a solvent, wherein the medicine is at least one of taxanes and macrolides; the excipient is at least one of iopromide, polyvinylpyrrolidone, polysorbate and polyethylene glycol; and the solvent is at least one of water, methanol, ethanol, acetone, isopropanol, acetonitrile, ethyl acetate and methyl formate. According to the method, by optimizing the composition of coating raw materials, the proportion of raw materials and the process parameter in the coating preparation method, the coating cannot be easily separated before reaching the target site and can quickly release the medicine when reaching the target site, the target tissue can be promoted to absorb the medicine in the coating, the medicine duration in the target tissue can be improved, and the vessel restenosis rate after interventional therapy can be reduced.

Description

technical field [0001] The invention belongs to the field of medical devices, and in particular relates to a drug-coated balloon and a preparation method thereof. Background technique [0002] Percutaneous coronary intervention has become the main method for the treatment of coronary heart disease. In the past 10 years, the number of cases of percutaneous coronary intervention for coronary heart disease in my country has maintained an average annual growth rate of 15% to 20%. At present, drug-coated balloons, as a new interventional therapy technology, are gradually being widely used in the field of coronary artery and peripheral interventions in Europe. There are also a number of drug-coated balloon products that have been or will be put into clinical use in China. [0003] The drug-coated balloon achieves the effect of inhibiting vascular intimal hyperplasia by locally releasing anti-proliferative drugs to the coronary artery wall. Compared with drug-eluting stents, the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/16A61L29/08
Inventor 翁玉麟石全刘宝瑞
Owner DK MEDICAL TECH CO LTD
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