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Drug-coated balloon catheter

A technology of drug-coated and balloon catheters, applied in catheters, coatings, medical science, etc., can solve the problems of restenosis of blood vessels, high restenosis rate of bare balloons, failure to show effectiveness or safety, and achieve Prevent large-area agglomeration, reduce the probability of agglomeration, and reduce the effect of coating safety

Inactive Publication Date: 2017-01-04
LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The invention of the stent provides a better solution for atherosclerosis and intravascular stenosis, which greatly improves the treatment efficiency, but at the same time, intravascular and intrastent restenosis occurs. For small vessels, bifurcated vessels and in situ Due to the unsatisfactory treatment effect of lesions and other shortcomings, the absolute number of patients with stent restenosis is considerable due to the increase in the number of patients receiving PCI treatment.
At present, the methods used for restenosis include: simple balloon re-expansion, directional atherectomy, rotational atherectomy, intravascular radiotherapy and repeated stent implantation, etc. Existing bare balloon and drug stents exist Certain limitations, the restenosis rate of the bare balloon is relatively high, and the therapeutic effect of the drug stent on small vessels and bifurcated vessels is not good, neither of which has shown its ideal effectiveness or safety

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] 250mg paclitaxel, 5.0mg citrate, 0.1mg aminoalcohol, 10ml ethanol, 4ml purified water were mixed to prepare a coating solution, wherein the mass ratio of the active drug to the carrier was 49; the PTA balloon catheter (diameter 4mm, long 40mm) 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) onto 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

[0039]11mg rapamycin, 17mg lactate, 5mg mannitol, 7ml ethanol, 3ml purified water were mixed to prepare a solution, wherein the mass ratio of the active drug to the carrier was 0.5; the PTA balloon catheter (diameter 4mm, long 40mm) was placed on After the flaps were folded in three in a class 10,000 clean environment, the coating solution was drip-coated on the surface of the polyester balloon with a precision syringe (accurate to 2 μl) in a class 100 clean environment, and then the balloon was dried and repeated. Drop coating until the drug concentration on the surface of the balloon reaches 3 μg / mm 2 , dried for 24 hours, packaged, and ethylene oxide sterilized.

Embodiment 3

[0041] 120mg paclitaxel, 36mg sodium benzoate, 12mg polyethylene glycol 2000, 10ml ethanol, 4ml purified water were mixed to prepare coating solution, wherein the mass ratio of active drug and carrier was 2.5; the PTA balloon catheter (diameter 4mm, long 40mm) 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 drug-coated balloon catheter. The drug-coated balloon catheter comprises a balloon and a drug coating on the surface of the balloon. The drug coating comprises an active drug and a carrier. The active drug is paclitaxel, rapamycin, a paclitaxel derivative or a rapamycin derivative. The carrier comprises an organic acid salt and polyol. A mass ratio of the active drug to the carrier in the drug coating is 0.5-49. A mass ratio of the organic acid salt to polyol is (3-50): 1. The organic acid salt and polyol in the drug coating produce synergism, drug particles have small particle sizes, premature release of the drug before displacement of the balloon catheter to a target point is prevented, balloon surface drug fast release is promoted, drug absorption by target tissue is promoted, a drug loss is reduced in a conveying process, particle falling is reduced, coating safety is improved and good drug transshipment effects are obtained.

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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IPC IPC(8): A61L29/16A61L29/08
CPCA61L31/08A61L31/16
Inventor 谢琦宗卢金华
Owner LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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