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Drug balloon and preparation method and application thereof

A balloon and drug technology, applied in balloon catheters, catheters, coatings, etc., can solve the problems of uneven distribution of coating drugs, easy to be washed out by blood flow, poor firmness, etc., and achieve easy long-term treatment. Effect, good firmness, not easy to fall off

Pending Publication Date: 2021-03-19
SHANGHAI XINZHI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is: how to solve the problem of uneven drug distribution and poor firmness of the coating of the drug balloon, and the drug is easily absorbed by the blood during delivery in the body or when it is adsorbed on the blood vessel wall. flow out problem

Method used

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  • Drug balloon and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0027] The structure of the drug balloon of the present invention is as follows: figure 1 As shown, the circled area is the enlarged structure of the drug coating on the balloon. In order to prepare a drug balloon, the present invention provides a method for preparing a drug balloon, the preparation method comprising the following steps:

[0028] (1) curing the elastic substance or elastic device on the surface of the balloon to obtain a balloon with the elastic substance or elastic device modified on the surface;

[0029] (2) Spraying drug solution, drug and adjuvant mixed solution, drug particle suspension, drug and adjuvant to form granules or any combination of mixed granules on the surface modified elastic material or elastic device balloon obtained in step (1), to obtain A balloon with a drug coating on the surface; the drug or drug particles can be crystalline particles formed by pure drugs, amorphous particles or particles mixed with the two, particles formed by drugs...

Embodiment 1

[0043] In this example, drug balloons were prepared by the following method:

[0044] (1) Utilize ultraviolet light to carry out photocuring and cure the chitosan (molecular weight is about 5 * 105) that N-deacetylation degree is 85% to the balloon surface, obtain the balloon that the surface is modified with chitosan; Said chitosan The sugar is chitosan modified through hydroxyethylation;

[0045] (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 accurately 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;

[0046] (3) Th...

Embodiment 2

[0048] In this example, drug balloons were prepared by the following method:

[0049] (1) Utilize ultraviolet light to carry out photocuring, and the chitosan (molecular weight is about 3 * 105) that N-deacetylation degree is 70% is cured to the balloon surface, obtains the balloon that the surface is modified with chitosan; Said chitosan Sugar is modified chitosan through carboxymethylation;

[0050] (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 accurately 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 ...

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Abstract

The invention discloses a drug balloon and a preparation method and application thereof, and relates to the field of medical equipment. The preparation method comprises the following steps: (1) solidifying an elastic substance or an elastic device to the surface of a balloon to obtain the balloon with the surface modified with the elastic substance or the elastic device; (2) spraying a drug solution, a drug and auxiliary material mixed solution, a drug particle suspension, drug and auxiliary material formed particles or randomly-combined mixed particles on the balloon with the surface modifiedwith the elastic substance or the elastic device obtained in the step (1), so as to obtain a balloon with a drug coating on the surface; and (3) carrying out surface solvation treatment on the balloon with the drug coating on the surface obtained in the step (2), and carrying out sectioning and folding to obtain the drug balloon. Through the implementation of the invention, the problem of washoutof the drug coating in the in-vivo delivery process is solved, the drug is uniform in distribution and good in firmness, drug particles completely or mostly enter vascular wall tissues, thus being easy to play a long-acting treatment effect.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a method for preparing a drug balloon, the prepared drug balloon and applications 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. 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. The emergence of drug-eluting balloons has brought new hope for solving restenosis, which essentially originates from the concept of catheter-based...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61L29/08A61L29/14A61L29/16
CPCA61M25/1029A61L29/08A61L29/085A61L29/16A61L29/14A61M2025/1031A61M2025/105A61L2300/606A61L2300/416C08L5/08
Inventor 盛卫文
Owner SHANGHAI XINZHI MEDICAL TECH CO LTD