Drug balloon and preparation method thereof

A drug and balloon technology, applied in the field of medical devices, can solve the problems of high drug residue, large drug delivery loss, uncontrollable drug metabolism speed, etc., to protect the drug-loaded layer, reduce drug loss, and improve the effect of treatment

Pending Publication Date: 2022-03-08
SHANGHAI VASOLUTIONS MEDTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to provide a drug balloon and its preparation method, which are used to solve the problems of large drug delivery loss, high drug residue on the surface of the balloon, and uncontrollable drug metabolism rate.

Method used

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  • Drug balloon and preparation method thereof
  • Drug balloon and preparation method thereof
  • Drug balloon and preparation method thereof

Examples

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preparation example Construction

[0073] Further, such as figure 2 As shown, the embodiment of the present invention also provides a preparation method of a drug balloon, comprising the following steps:

[0074] Step S11: providing a balloon body 1; the present invention does not limit the structure of the balloon body 1;

[0075] Step S12: setting the bottom layer 2 on the outer surface of the balloon body;

[0076] Step S13: setting the drug-loaded layer 3 on the surface of the bottom layer 2;

[0077] Step S14: setting the functional layer 4 on the surface of the drug-loaded layer 3 .

Embodiment 1

[0080]First, take 5 balloon catheters of 3.0mm*20mm (diameter*length), the material of each balloon catheter is Pebax (block polyether amide), and do the following for each balloon catheter:

[0081] Step 1: Wipe the surface of the balloon with 75% ethanol and set aside.

[0082] Step 2: Use plasma cleaning technology to clean the debris on the surface of the balloon. The plasma cleaning time is 15 minutes; the plasma cleaning technology uses argon as an inert gas, the power is 100KHz, and the pressure in the working chamber is 0.3atm during cleaning.

[0083] Step 3: Using dextran as the bottom layer material, spray a layer of dextran bottom layer with a molecular weight of 150K on the surface of the balloon, and the thickness of the bottom layer is 0.1 μm.

[0084] Step 4: Dissolve 500 mg of rapamycin and 5 g of polyethylene glycol in ethanol to prepare a drug-loaded layer solution with a drug concentration of 50 mg / mL, and spray the drug-loaded layer solution on the surface...

Embodiment 2

[0087] Same as Example 1, get 5 balloon catheters of 3.0mm*20mm (diameter*long), the material of the balloon of each balloon catheter is Pebax, and each balloon catheter is processed as follows:

[0088] Step 1: Wipe the surface of the balloon with 75% ethanol and set aside.

[0089] Step 2: Use plasma cleaning technology to clean the debris on the surface of the balloon. The plasma cleaning time is 15 minutes; the plasma cleaning technology uses argon as an inert gas, the power is 100KHz, and the pressure in the working chamber is 0.3atm during cleaning.

[0090] Step 3: Using dextran as the bottom layer material, spray a layer of dextran bottom layer with a molecular weight of 150K on the surface of the balloon, and the thickness of the bottom layer is 0.1 μm.

[0091] Step 4: Dissolve 500mg of paclitaxel and 5g of polyethylene glycol in ethanol to prepare a drug-loaded layer solution with a drug concentration of 50mg / mL, and spray the drug-loaded layer solution on the surfa...

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Abstract

The invention relates to a drug balloon and a preparation method thereof.The drug balloon comprises a balloon body and a coating arranged on the surface of the balloon body, the coating sequentially comprises a bottom layer, a drug carrying layer and a functional layer from inside to outside, the bottom layer comprises a hydrophilic material and / or a lipophilic material, the drug carrying layer comprises a drug and a carrier, and the functional layer comprises a hydrophilic material and / or a lipophilic material. The functional layer comprises a medicine and a functional material, and the functional material comprises at least one of a medicine receptor protein inhibitor, a medicine metabolism isoenzyme inducer and a medicine metabolism isoenzyme inhibitor. The preparation method has the advantages that adhesion between the medicine and the surface of the balloon can be reduced through the bottom layer, medicine residues on the surface of the balloon are reduced, medicine loss in the conveying process can be reduced through the functional layer, and the metabolism speed of the medicine can be adjusted.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a drug balloon and a preparation method thereof. Background technique [0002] Drug balloon catheter is an interventional treatment method combining traditional balloon angioplasty and advanced drug eluting technology. During interventional treatment, the drug on the drug balloon catheter can be released quickly when the balloon reaches the lesion, avoiding the side effects caused by the long-term retention of metal stents and polymer carriers, and is an effective method for metal stent angioplasty. Supplement, it has a good application in the process of vascular restenosis after drug stent implantation, and gradually shows its superiority. However, there is still a large amount of drug loss on the surface of the balloon catheter during the delivery process of the drug balloon catheter, and most of the drug remains on the surface of the balloon (about 10-20%) after inter...

Claims

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Application Information

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IPC IPC(8): A61L29/08A61L29/14A61L29/16
CPCA61L29/085A61L29/08A61L29/16A61L29/14A61L2300/416A61L2300/606A61L2300/256A61L2300/608A61L2420/02A61L2420/08A61L2300/602C08L5/02C08L71/02A61M25/10A61M31/00
Inventor 朱熠门郭芳朱清南文斌
Owner SHANGHAI VASOLUTIONS MEDTECH CO LTD
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