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Method for preparing balloon dilatation catheter medicinal coating for treatment

A technology for dilating catheters and drug coatings, applied in coatings, medical science, surgery, etc., can solve problems such as high material consumption, narrow stents, large airflow, and the environment, and achieve uniform drug coating, long-lasting drug effects, crystal Effects with controllable granularity

Active Publication Date: 2015-02-04
ZHEJIANG BELONGS TO A MEDICAL INSTR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problem with DES is late in-stent restenosis
However, the traditional gas spray method requires a large air flow and environmental control, and consumes a lot of materials.

Method used

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  • Method for preparing balloon dilatation catheter medicinal coating for treatment
  • Method for preparing balloon dilatation catheter medicinal coating for treatment
  • Method for preparing balloon dilatation catheter medicinal coating for treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1: Preparation method of paclitaxel drug-coated balloon:

[0045] Step 1, paclitaxel solution: Weigh about 0.15g of paclitaxel and add it to a 25ml glass bottle; add 20ml of acetonitrile / acetone 1:1 (v / v) mixed solution into the glass bottle, shake until the paclitaxel is completely dissolved.

[0046] Step 2, paclitaxel incompatible solution: 0.18g of PVP was dissolved in 20ml of 75% medical alcohol.

[0047] Step 3, spraying parameters: pressurize a 2.0*20mm balloon until it is fully stretched and place it under the ultrasonic nozzle, the ultrasonic frequency is 25kHz, the ultrasonic power is set to 1w, the flow rate of paclitaxel solution is 0.1ml / min, paclitaxel does not The flow rate of the compatible solution is 0.05ml / min, the rotation speed of the balloon is 3r / s, the spraying stroke is 20mm, the spraying time is 0.5min, and the carrier gas pressure is 1psi; after spraying, take out the balloon.

[0048] In step 4, the balloon is dried for 30 minutes...

Embodiment 2

[0050] Embodiment 2: Preparation method of paclitaxel drug-coated balloon:

[0051] Step 1, paclitaxel solution: Weigh about 0.13g of paclitaxel and add it to a 15ml glass bottle; add 10ml of a mixed solution of ethanol / n-hexane 3:1 (v / v) into the glass bottle and shake until the paclitaxel is completely dissolved.

[0052] Step 2, paclitaxel-incompatible solution: an aqueous solution with a PEG content of 20 mg / ml.

[0053] Step 3, spraying parameters: pressurize a 3.0*15mm balloon until it is fully stretched and place it under the ultrasonic nozzle, the ultrasonic frequency is 60kHz, the ultrasonic power is set to 0.8w, the flow rate of paclitaxel solution is 0.15ml / min, paclitaxel The incompatible solution flow rate is 0.1ml / min, the balloon rotation speed is 3r / s, the spraying stroke is 15mm, the spraying time is 1.1min, and the carrier gas pressure is 1psi; after the spraying, take out the balloon.

[0054] In step 4, the balloon is dried for 60 minutes at a temperature ...

Embodiment 3

[0056] Embodiment 3: Preparation method of paclitaxel drug-coated balloon:

[0057] Step 1, paclitaxel solution: Weigh about 0.13g of paclitaxel and add it to a 15ml glass bottle; add 10ml of methanol / isopropanol 2:1 (v / v) mixed solution into the glass bottle, shake until the paclitaxel is completely dissolved.

[0058] Step 2, paclitaxel-incompatible solution: 50% water / acetone solution with a PVA content of 10 mg / ml.

[0059] Step 3, spraying parameters: pressurize a 6.0*40mm balloon until it is fully stretched and place it under the ultrasonic nozzle, the ultrasonic frequency is 50kHz, the ultrasonic power is set to 4w, the flow rate of paclitaxel solution is 0.2ml / min, paclitaxel does not The flow rate of the compatible solution is 0.2ml / min, the rotation speed of the balloon is 5r / s, the spraying stroke is 40mm, the spraying time is 3min, and the carrier gas pressure is 1psi; after spraying, take out the balloon.

[0060] In step 4, the balloon is dried for 10 minutes at...

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Abstract

The invention relates to a method for preparing a balloon dilatation catheter medicinal coating for treatment. The method comprises the following steps: adding a diluted solvent into a glass bottle filled with a medicine for treating vascular endothelial re-proliferation, oscillating to completely dissolve the medicine to prepare a medicine solution; mixing the medicine solution and an interference solvent which is incompatible with the medicine, and feeding into a dual-channel ultrasonic nozzle to coat a balloon dilatation catheter; drying, sterilizing and packaging the coated balloon dilatation catheter. According to the method, the medicine solution is mixed with another incompatible interference solvent before ultrasonic coating, so that the shape of the medicine in the solution is changed, and the mixture is fed into the ultrasonic nozzle to perform ultrasonic coating to achieve the aims of controlling the coating granularity, increasing the coating binding force and controlling the releasing rate of the medicine. The medicine coating formed by the method has the characteristics of uniformity, strong binding force with balloon, controllable crystal granularity, durable drug effect and the like.

Description

[0001] technical field [0002] The invention relates to the technical field of medical device preparation, in particular to a method for preparing a medical coating of a therapeutic balloon dilatation catheter. [0003] Background technique [0004] The use of percutaneous balloon angioplasty to reopen narrowed diseased vessels is a revolution in revascularization. However, balloon angioplasty has obvious defects in long diseased blood vessels and small blood vessels, and the blood vessels after dredging are prone to restenosis. The stent in the stent operation can eliminate the elastic recoil of the blood vessel and the late negative vascular remodeling after simple balloon dilation because it provides a certain mechanical support for the blood vessel, but it can also cause excessive inflammatory reactions, resulting in more Intimal hyperplasia, causing in-stent restenosis (ISR). The major limitation of stents is stent thrombosis, which needs to be controlled with antip...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/16A61L31/08
CPCA61M25/1029A61M2025/1031A61M2025/105
Inventor 季培红颜玉强常婷高飞赵中
Owner ZHEJIANG BELONGS TO A MEDICAL INSTR
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