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Novel drug eluting balloon catheter

A balloon catheter and drug technology, applied in balloon catheters, drug devices, other medical devices, etc., can solve the problems of difficult solution retention, damage to coating integrity, complicated production process, etc., and achieve low hydrophilicity, Good lipophilic and hydrophilic properties, the effect of reducing loss

Pending Publication Date: 2015-09-02
SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The structure of the balloon is complex, and physiological saline is injected into the wall of the balloon. On the one hand, the production process is complicated;

Method used

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  • Novel drug eluting balloon catheter

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Such as figure 2 As shown, firstly, the surface of the balloon is pretreated by plasma cleaning technology, and the debris on the surface of the balloon is cleaned by using plasma cleaning technology. The plasma cleaning preferably uses an inert gas, such as argon, with a power of 50KHz. The pressure is 0.1atmatm, and the cleaning time is 10min. Then use polyethylene glycol with good hydrophilicity and lipophilicity as the bottom layer material (such as figure 1 As shown, the polymer material has both hydrophilic groups and lipophilic groups), then spray the polyethylene glycol bottom layer with a molecular weight of 70K, with a thickness of 1 μm, and then spray a layer of polyethylene glycol with a molecular weight of 15K and paclitaxel mixed Drug-loaded coating with a drug loading of 2.5 μg / mm 2 , with a thickness of 10 μm; after the coating is dry, it is finally folded.

Embodiment 2

[0041] Such as image 3 As shown, firstly, the surface of the balloon is pretreated by plasma cleaning technology, and the impurities on the surface of the balloon are cleaned by using plasma cleaning technology. The plasma cleaning preferably uses an inert gas, such as neon gas, with a power of 10KHz. The pressure is 0.01atm, and the cleaning time is 5min. Then take the hydrophilic and lipophilic polystearate as the bottom material (such as figure 1 As shown, the polymer material has both hydrophilic groups and lipophilic groups), spraying one deck of molecular weight is 51K polystearic acid ester bottom layer, thickness 2 μ m, then spraying one layer of molecular weight is 5K hardic acid ester and Paclitaxel-mixed drug-loaded coating with a drug loading of 1 μg / mm 2 , with a thickness of 50 μm; after the coating is dried, folded, wound and then sprayed with a surface layer of polyglycerol ester with a molecular weight of 2K, the thickness is 2 μm.

Embodiment 3

[0043] Such as image 3 As shown, firstly, the surface of the balloon is pretreated by plasma cleaning technology, and the impurities on the surface of the balloon are cleaned by using plasma cleaning technology. Preferably, the plasma cleaning uses an inert gas, such as argon, with a power of 50KHz. The pressure is 0.1atm, and the cleaning time is 10min. Then use lipophilic and hydrophilic dextran as the bottom material (such as figure 1 As shown, the polymer material has both hydrophilic groups and lipophilic groups), spraying a layer of dextran bottom layer with a molecular weight of 150K, with a thickness of 0.1 μm, and then spraying a layer of dextran and rapamycin with a molecular weight of 39K Drug-loaded coating mixed with prime, with a drug loading of 2.5 μg / mm 2 , with a thickness of 1 μm; after the coating is dried, folded, wound up and then sprayed with a layer of polycitrate with a molecular weight of 39K, the thickness is 0.1 μm.

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Abstract

The invention provides a novel drug eluting balloon catheter. The novel drug eluting balloon catheter comprises a catheter body, a balloon body (1) and a balloon surface (2) and further comprises a hydrophilic and lipophilic bottom layer (3) and a drug loading coating layer (4). The hydrophilic and lipophilic bottom layer (3) is arranged on the upper surface of the balloon surface (2), the drug loading coating layer (4) is arranged on the upper surface of the hydrophilic and lipophilic bottom layer (3), and the drug loading coating layer (4) is composed of polymer and drug. The novel drug eluting balloon catheter has the advantages of simple structure, simple production process and procedures, low drug loss during delivery and low drug residues on the balloon after interventional operation.

Description

technical field [0001] The invention designs a medical device, especially a novel drug-eluting balloon used for interventional treatment of cardiovascular diseases. Background technique [0002] The drug-eluting balloon catheter is a combination of traditional balloon angioplasty and advanced drug-eluting technology. The drug-eluting balloon catheter releases drugs immediately during interventional therapy, avoiding the long-term retention of metal stents and polymer carriers. It is an effective supplement to metal stent angioplasty. It has a good application in the process of vascular restenosis after drug stent implantation, and gradually shows its superiority. However, drug-eluting balloons still have drug surface A large amount of drugs are lost during the intervention process, resulting in low drug loading rate in the diseased tissue and some drugs still adhere to the surface of the balloon (about 10-20%) after interventional treatment, affecting drug release. The prob...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61M31/00
Inventor 刘庄申峰袁玲
Owner SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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