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Preparation method of drug balloon

A technology of balloons and drugs, which is applied in the fields of medical devices, medical science, surgery, etc., can solve the problems of high mortality rate, poor prognosis of lower limb ischemia, etc., and achieve enhanced coating fastness, good clinical efficacy, and protection of its own characteristics Effect

Active Publication Date: 2018-05-22
普霖医疗科技(广州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Severe lower extremity ischemia has poor prognosis and high mortality

Method used

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  • Preparation method of drug balloon
  • Preparation method of drug balloon
  • Preparation method of drug balloon

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0036] A preparation method of a drug balloon, comprising the following steps:

[0037] 1) Take a few drops of the underlying solution and evenly coat the surface of the balloon so that the concentration of the underlying substance on the surface of the balloon is 0.5-5 μg / mm 2 , dry the bottom layer solution, and dry it at room temperature for at least 30 minutes to obtain a balloon coated with the bottom layer;

[0038] 2) Take a few drops of the middle layer solution and evenly coat the surface of the bottom-coated balloon obtained in the previous step, so that the concentration of the middle layer substance on the bottom-coated balloon surface is 4-30 μg / mm 2 , dry the middle layer solution, and after drying at room temperature for at least 20 minutes, a balloon coated with the middle layer is obtained;

[0039] 3) Drop the drug solution of appropriate concentration on the surface of the balloon coated with the middle layer, rotate the balloon while dripping, so that the ...

Embodiment 1

[0057] 1. Balloon Processing

[0058] The polyethylene balloon used for the coating is first processed as follows: trimming→inflating→sealing→cleaning→drying→drying→weighing.

[0059] 2. Coating the bottom layer

[0060] 2.1 Applying the bottom layer: Take an appropriate amount of bottom layer solution (polyethylene oxide solution) with a concentration of 20.1 mg / ml, pour it into a special glass container, and dip two drops of bottom layer solution with a coating brush to evenly coat the surface of the balloon , so that the concentration of the underlying substance on the surface of the balloon is 3 μg / mm 2 . Turn on the fan (low wind speed, no heating), and the distance is about 45-60cm. Use a coating brush to coat the balloon back and forth, and the bottom layer solution is completely dry in about 90 seconds, and the ambient temperature needs to be controlled between 22-25°C.

[0061] 2.2 Weigh the weight of the balloon coated with the bottom layer: dry the balloon coate...

Embodiment 2

[0070] Embodiment 2 A preparation method of a drug balloon,

[0071] 1) Take a few drops of the bottom layer solution (25mg / ml) and evenly coat it on the surface of the balloon (the material of the balloon is polyethylene), so that the concentration of the bottom layer substance on the surface of the balloon is 1.32 μg / mm 2 , under the condition of 28°C, use the wind to dry the bottom layer solution within 110s (rotate the balloon back and forth during the drying process), and after drying at room temperature for at least 30 minutes, a balloon coated with the bottom layer is obtained;

[0072] 2) Take a few drops of the middle layer solution (100mg / ml) and evenly coat it on the surface of the bottom-coated balloon obtained in the previous step, so that the concentration of the middle layer substance on the bottom-coated balloon surface is 4.82 μg / mm 2 , use the wind to dry the middle layer solution within 80s (rotate the balloon back and forth during the drying process), dry a...

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Abstract

The invention discloses a preparation method of a drug balloon. According to the method, a layered coating is adopted for a drug transfer layer used by the drug balloon, and a bottom layer is coated with the drug transfer layer which is called as a middle layer. In the coating process, drug transfer catalysts are stacked on the bottom layer but are not mixed with the bottom layer. The drug balloonprovides convenience for the process that the largest quantity of drugs are transferred to the vessel wall from the surface of the balloon within a short period. The drug coating is quickly releasedand absorbed and slowly eliminated in the target blood vessel part, that is to say that a peripheral vascular drug balloon dilation catheter can achieve an effective drug function, and the drug balloon has good clinical application prospects.

Description

technical field [0001] The invention relates to a preparation method of a drug balloon. Background technique [0002] The global burden of peripheral arterial disease (PAD) is increasing, from 164 million in 2000 to 202 million in 2010, an increase in prevalence of nearly a quarter (23.5%). As this population ages, the incidence of peripheral artery disease increases substantially with age; the number of patients with peripheral artery disease will continue to increase in the coming years. [0003] Lower extremity peripheral arterial disease (PAD) is an important manifestation of systemic atherosclerosis. The disease results from one or more atherosclerotic lesions (restricting or blocking blood flow to the lower extremities) of the arteries of the lower extremities. [0004] Arterial occlusion of the lower extremities causes clinical manifestations ranging from asymptomatic to intermittent claudication (IC) and eventually to critical lower extremity ischemia (CLI), in whi...

Claims

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Application Information

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IPC IPC(8): A61M31/00A61L31/10A61L31/08A61L31/16
CPCA61L31/08A61L31/10A61L31/16A61L2300/602A61L2300/606A61L2420/02A61L2420/08A61M31/002
Inventor 韩晓阳曾毅杨大川彭海成杜玲
Owner 普霖医疗科技(广州)有限公司