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A preparation method of a drug balloon, the prepared drug balloon and its application

A balloon and drug technology, applied in the field of medical devices, can solve the problems of poor firmness and uneven distribution of drugs in drug coatings, and achieve the effects of difficult drug washout, enhanced bioavailability, and firm drug coatings.

Active Publication Date: 2020-08-07
LEPU MEDICAL TECH (BEIJING) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problem is that the drug coating obtained by dip coating is uneven in drug distribution and poor in firmness

Method used

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  • A preparation method of a drug balloon, the prepared drug balloon and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] In this example, drug balloons were prepared by the following method:

[0050] (1) Utilize ultraviolet light to carry out photocuring and N-deacetylation degree is 85% chitosan (molecular weight is about 5 * 10 5 ) is solidified to the surface of the balloon to obtain a balloon with chitosan modified on the surface; the chitosan is chitosan modified through hydroxyethylation;

[0051] (2) on the balloon that the surface modification that step (1) obtains has chitosan, spray medicine solution, described medicine solution is the solution that comprises active drug paclitaxel and carrier mannitol, and drug concentration is 30mg / mL, in order to prepare and control the amount of drug solution sprayed onto the balloon, use a precision injector and a sprayer to spray to obtain a uniform drug coating, and achieve the expected drug amount by controlling the process parameters. After the spraying is completed, the surface is obtained. Drug-coated balloons;

[0052] (3) The sur...

Embodiment 2

[0054] In this example, drug balloons were prepared by the following method:

[0055] (1) Utilize ultraviolet light to carry out photocuring and N-deacetylation degree is 70% chitosan (molecular weight is about 3 * 10 5 ) is solidified to the surface of the balloon to obtain a balloon with chitosan modified on the surface; the chitosan is modified chitosan through carboxymethylation;

[0056] (2) on the balloon that the surface modification that step (1) obtains has chitosan, spray drug solution, described drug solution is the solution that comprises active drug paclitaxel and carrier nicotinamide, and drug concentration in described drug solution is 30mg / mL, in order to prepare and control the amount of drug solution sprayed onto the balloon, use a precision injector and a sprayer to spray to obtain a uniform drug coating, and achieve the expected drug amount by controlling the process parameters. After the spraying is completed, the surface is obtained. Drug-coated balloon...

Embodiment 3

[0059] In this example, drug balloons were prepared by the following method:

[0060] (1) Utilize ultraviolet light to carry out photocuring and N-deacetylation degree is 70% chitosan (molecular weight is 3 * 10 5 ) is solidified to the surface of the balloon to obtain a balloon with chitosan modified on the surface; the chitosan is chitosan modified through sulfonate esterification;

[0061] (2) on the balloon that the surface modification that step (1) obtains has chitosan, sprays drug solution, and described drug solution is the solution that comprises active drug paclitaxel and carrier lactose, and drug concentration is 50mg / mL in described drug solution , in order to prepare to control the amount of drug solution sprayed onto the balloon, use a precision injector and a sprayer for spraying to obtain a uniform drug coating. By controlling the process parameters to achieve the expected drug dosage, the spraying is completed, and the balloon with drug coating on the surface...

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PUM

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Abstract

The invention provides a preparation method of drug balloons as well as the drug balloons prepared by the preparation method and application thereof. The preparation method is characterized by comprising the following steps: curing chitosan to surfaces of balloons to obtain balloons with surfaces modified by the chitosan; spraying a drug solution on the obtained balloons with the surfaces modified by the chitosan to obtain the balloons with surfaces provided with drug coatings; carrying out surface solvation treatment on the balloons and carrying out segmented folding and packing to obtain the drug balloons. According to the drug balloons prepared by the preparation method provided by the invention, the drug coatings can be uniformly and firmly combined on the surfaces of the balloons and not easily fall off; drugs are prevented from being washed off in an in-vivo conveying process; the loss of drugs is reduced and the utilization rate of the drugs is improved; the preparation method provided by the invention is accurate, stable and efficient, is suitable for industrial large-scale production and has a wide application prospect.

Description

technical field [0001] The invention belongs to the field of medical devices, and relates to a preparation method of a drug balloon, the prepared drug balloon and an application thereof. Background technique [0002] Vascular stenosis can easily lead to poor blood flow in blood vessels, and even blockage of blood vessels can be life-threatening. Currently, the main treatment methods for vascular stenosis include placement of vascular stents and drug delivery through drug balloons. [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 Disadvantages such as unsatisfactory therapeutic effect of pathological changes etc. [0004] The emergence of drug-eluting balloons has brought new hope for solving restenosis, which essentially originates from the concep...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L29/08A61L29/16A61M31/00
CPCA61L29/085A61L29/16A61L2300/416A61L2300/606A61M31/00A61M2210/12C08L5/08A61M2210/005
Inventor 张毅赵丽晓赵轩铖李京龙梁红梅
Owner LEPU MEDICAL TECH (BEIJING) CO LTD
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