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Medicinal coating balloon catheter

A drug-coated and balloon-catheter technology, applied in the direction of balloon-shaped catheters, catheters, coatings, etc., to achieve good safety and biocompatibility, good drug transfer effect, and accelerated release and absorption effects

Active Publication Date: 2014-04-23
LIFETECH SCI (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The existing marketed drug expansion balloon catheter uses the contrast agent iopromide as a carrier and paclitaxel as a drug coating on the balloon catheter to treat coronary restenosis, which can improve the drug transfer rate, but the contrast agent In the diagnosis process, there is a certain incidence of complications, and because iopromide is a large hydrophilic molecule, it cannot effectively carry lipophilic paclitaxel through the membrane lipid bilayer into the cell

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Mix 120mg of paclitaxel, 1.0mg of citrate, 0.1mg of amino alcohol, 10ml of ethanol, and 4ml of purified water to prepare a coating solution, wherein the mass ratio of the active drug to the carrier is 100; the PTCA balloon catheter (diameter 3mm, length 20mm) After the flaps were folded in three in a class 10,000 clean environment, the coating solution was drip-coated with a precision syringe (accurate to 2 μl) on the surface of the polyester balloon behind the flaps in a class 100 clean environment, and then the balloon was dried , repeated dripping until the drug concentration on the surface of the balloon reached 20 μg / mm 2 , dried for 24 hours, packaged, and ethylene oxide sterilized.

Embodiment 2

[0029] Mix 20mg of rapamycin, 17mg of lactate, 83mg of mannitol, 7ml of ethanol, and 3ml of purified water to prepare a solution, in which the mass ratio of the active drug to the carrier is 0.2; a PTCA balloon catheter (diameter 3mm, length 20mm) was placed in the After folding the wings in three in a class 10,000 clean environment, apply the coating solution onto the surface of the polyester balloon with a precision syringe (accurate to 2 μl) in a class 100 clean environment, then dry the balloon and repeat Drop coating until the drug concentration on the surface of the balloon reaches 1 μg / mm 2 , dried for 24 hours, packaged, and ethylene oxide sterilized.

Embodiment 3

[0031] Mix 120mg of paclitaxel, 36mg of sodium benzoate, 36mg of polyethylene glycol 2000, 10ml of ethanol, and 4ml of purified water to prepare a coating solution, in which the mass ratio of the active drug to the carrier is 1.67; the PTCA balloon catheter (diameter 3mm, length 20mm) After the wings were folded in three in a class 10,000 clean environment, the coating solution was sprayed onto the surface of the polyester balloon after the flaps were folded in a class 100 clean environment, so that the drug concentration on the surface of the balloon reached 3 μg / mm 2 , dried, packaged, and ethylene oxide sterilized.

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Abstract

The invention relates to a medicinal coating balloon catheter. The balloon catheter comprises a balloon and a medicinal coating, wherein the surface of the balloon is coated with the medicinal coating; the medicinal coating comprises an active medicine and a carrier, the active medicine is paclitaxel, sirolimus, paclitaxel derivative or sirolimus derivative; the carrier comprises organic acid salt and polyhydric alcohols; the mass ratio of the active medicine to the carrier in the medicinal coating is 0.2-100, and the mass ratio of the organic acid to polyhydric alcohols is (0.2-5):1. The organic acid salt and the polyhydric alcohols in the medicinal coating play effects together, so that premature drug release of the balloon catheter before the balloon catheter is implanted to a target point can be prevented, the medicine is accelerate to quickly release from the surface of the balloon and to be absorbed by a target tissue, drug loss in the transporting process can be reduced, and the balloon catheter has a good drug transfer effect.

Description

technical field [0001] The invention belongs to the field of interventional medical devices, in particular to a drug-coated balloon catheter. Background technique [0002] From the 1970s to the present, the field of cardiovascular interventional therapy has experienced three milestone leaps. In 1977, the human first used balloon to dilate coronary artery stenosis, which was the first milestone. Although balloon dilatation can eliminate coronary artery stenosis, the elastic recoil of the vessel wall, hyperplasia of the intimal layer, and tearing of the intimal wall can promote restenosis of the vessel, and restenosis of the target vessel occurs 3 to 6 months after surgery. The rate is as high as 30-50%. In 1986, the bare metal stent (abbreviation: BMS) came out. It can not only eliminate the immediate vascular stenosis, but also greatly reduce the incidence of acute reocclusion. It has become the second milestone in interventional therapy, but the incidence of target vessel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/08A61L31/16
CPCA61L29/06A61L29/14A61L2300/416A61L29/16C08L67/02C08L77/00C08L23/06A61M25/10A61M2025/105
Inventor 张永木谢琦宗卢金华宋精忠
Owner LIFETECH SCI (SHENZHEN) CO LTD
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