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Drug balloon as well as preparation method and application thereof

A balloon and drug technology, applied in the direction of balloon-shaped catheters, catheters, etc., can solve problems such as poor firmness, uneven drug distribution, drug coating wash-off, etc., to achieve enhanced bioavailability, firm drug coating, The effect that is not easy to wash off

Pending Publication Date: 2022-03-22
SHANGHAI XINZHI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 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 drug coating wash-off caused by coating the drug coating attached to the surface of the balloon during in vivo delivery and how to solve the problem of drug coating by dip coating The problem of uneven drug distribution and poor firmness caused by the drug coating obtained by coating the drug in the same way

Method used

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  • Drug balloon as well as preparation method and application thereof
  • Drug balloon as well as preparation method and application thereof
  • Drug balloon as well as preparation method and application thereof

Examples

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Effect test

preparation example Construction

[0053] like figure 1 Shown is a preparation method of a drug balloon of the present invention, the preparation method of the present invention includes: mixing the active drug and the carrier to form a mixed solution; spraying the mixed solution onto the surface of the balloon, and treating the solvent of the mixed solution evaporate to dryness to obtain the balloon with drug coating on the surface.

[0054] A preferred embodiment of the preparation method of the drug balloon of the present invention specifically includes the following steps:

[0055] Step 1, mixing the active drug and the carrier to form a mixed solution;

[0056] Step 2. Spray the mixed solution prepared in step 1 onto the surface of the balloon, and wait for the solvent to evaporate to dryness to obtain a balloon with a drug coating on the surface;

[0057] Step 3: Solve the surface of the drug-coated balloon prepared in step 2, and then perform split-folding to obtain a drug balloon.

[0058] In step 1,...

Embodiment 1

[0079] In this example, drug balloons were prepared by the following method:

[0080] Step 1, 30% active drug (rapamycin and its derivatives or paclitaxel) and 30% polyethylene glycol, 5% polyethylene glycol-polylactic glycolic acid, 35% phospholipids are fully dissolved in dichloromethane form a mixed solution;

[0081] Step 2. Spray the mixed solution of the active drug prepared in step 1 and polyethylene glycol, polyethylene glycol-polylactic-glycolic acid, and phospholipids directly onto the surface of the balloon. The drug solution contains the active drug rapamycin and its The solution of derivatives or paclitaxel and carrier mannitol, the drug concentration in the drug solution is 30mg / mL, in order to accurately control the amount of the drug solution sprayed onto the balloon, use a precision injector and a sprayer to spray to obtain a uniform Drug coating, by controlling the process parameters to achieve the expected drug dosage, after the spraying is completed, a bal...

Embodiment 2

[0084] In this example, drug balloons were prepared by the following method:

[0085] Step 1, 30% of active drug (rapamycin and its derivatives or paclitaxel) and PLGA material are prepared into 1-5 μm particles and 30% polyethylene glycol, 5% polyethylene glycol-polylactic acid by spray drying Glycolic acid and 35% phospholipids are fully dissolved in ethanol solution to form a suspension;

[0086] Step 2, the suspension prepared in step 1 is directly sprayed on the surface of the balloon, the drug suspension is a solution containing active drug rapamycin and its derivatives or paclitaxel PLGA particles and carrier, the drug PLGA particles are mixed The drug concentration in the suspension is 30mg / mL. In order to accurately control the amount of the drug solution sprayed onto the balloon, a precision injector and a sprayer are used for spraying to obtain a uniform drug coating. By controlling the process parameters to achieve the desired After the spraying is completed, a ba...

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Abstract

The invention discloses a medicine balloon and a preparation method and application thereof, and relates to the technical field of medical instruments.The preparation method of the medicine balloon comprises the steps that an active medicine or the active medicine and auxiliary materials are prepared into micron or nano particles with sustained and controlled release, and the micron or nano particles, polyethylene glycol and phospholipid form a mixed solution; and then curing the mixed solution to the surface of the balloon, and then carrying out solvation treatment and sectioning and packaging to obtain the drug balloon. Through the implementation of the preparation method, the drug coating can be uniformly and firmly combined on the surface of the balloon, the drug is prevented from being washed off in the in-vivo conveying process, the drug loss is reduced, the drug utilization rate is improved, and the preparation method is accurate, stable and efficient, is suitable for industrial large-scale production and has a wide application prospect.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a drug balloon and its preparation method and application. 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 The therapeutic effect of lesion etc. is not ideal. The emergence of drug-eluting balloons has brought new hope for solving restenosis, which essentially originates from the concept of catheter-based local drug delivery devices. The drugs carried by the b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10
CPCA61M25/1029A61M2025/1031
Inventor 盛卫文
Owner SHANGHAI XINZHI MEDICAL TECH CO LTD
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