Drug eluting balloon catheter and preparation method thereof

A technology of balloon catheters and drugs, which is applied in the direction of balloon catheters, catheters, drug delivery, etc., can solve the problems of strong adhesion between the hydrophobic coating and the surface of the balloon, and the difficulty of transferring drugs to tissues, so as to reduce the loss of drugs , Inhibit long-term restenosis and maintain integrity

Active Publication Date: 2019-10-01
SHANDONG RIENTECH MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the adhesion between the hydrophobic coating and the surface of the balloon is relatively large, and the drug is not easily transferred to the tissue during the contact process between the balloon and the target lesion tissue

Method used

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  • Drug eluting balloon catheter and preparation method thereof
  • Drug eluting balloon catheter and preparation method thereof
  • Drug eluting balloon catheter and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Weigh 10mg of rapamycin, dissolve it in 10ml of acetone, add this solution dropwise to 50ml of PVA solution with a mass fraction of 1%, and use ultrasonic emulsification at 4°C for 40 minutes, then stir the emulsion overnight at a speed of 1000rpm. After overnight, the emulsion was centrifuged at 3500rpm, and the supernatant was taken to obtain a suspension of rapamycin particles. The size and distribution of solid particles were tested with a nanoparticle size analyzer (Zetasizer Nano ZS90). The particle size range was 1.5 μm —6.0μm, the result is as follows image 3 .

Embodiment 2

[0039] Weigh 1 mg of rapamycin, dissolve it in 10 ml of acetone, add this solution dropwise to 100 ml of polysorbate 20 solution with a mass fraction of 2%, use ultrasonic emulsification at 4°C for 40 minutes, and then stir the emulsion overnight at Centrifuge the overnight emulsion at 3500rpm and take the supernatant to obtain a suspension of rapamycin particles. Use a nanoparticle size analyzer to test the size and distribution of solid particles. The particle size range is 0.5μm-5μm .

Embodiment 3

[0041] Weigh 100mg of rapamycin and 150mg of PDLGA with an intrinsic viscosity of 0.8dl / g, dissolve in 10ml of acetone and dichloromethane mixed solvent (volume ratio 2:8), add this solution dropwise to 100ml with a mass fraction of 2% polysorbate 80 solution, using a high-speed homogenizer to emulsify at 18000rpm for 4 minutes, then stir the emulsion overnight at 1000rpm, centrifuge the overnight emulsion at 3500rpm, take the supernatant, Both obtain the suspension of rapamycin particle, adopt the size and the distribution of solid particle test of nano particle size analyzer, particle size range 15nm-120nm, the result is as follows Figure 4 .

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Abstract

The invention relates to a drug eluting balloon catheter and a preparation method thereof. A drug consists of drug particles different in particle size, and the surfaces of the drug particles are coated with phospholipids; a drug coating consists of two parts; the part, close to a balloon, of the coating consists of a phospholipid-coated drug and a hydrophilic excipient, and the part, on the outermost layer, of the coating consists of a hydrophobic or amphiphilic excipient. The coating on the outer side reduces the resistance of the balloon penetrating through a blood vessel to a target lesionand reduces the drug loss during transport; the coating close to the balloon promotes rapid release of the drug from the balloon surface and absorption of the drug by the target vessel, and the drugdiffused to an outer membrane can be continuously released to peripheral tissue to inhibit long-term restenosis. The drug eluting balloon catheter has a good application prospect in interventional therapy.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a drug-eluting balloon catheter for angioplasty and a preparation method thereof. Background technique [0002] Since Gruntzig's first clinical application of percutaneous coronary intervention (PCI) in 1977, intravascular restenosis has been a major focus of therapeutic debate. The application of drug-eluting stents has effectively solved this problem, reducing the target vessel restenosis rate to less than 3%. However, in-stent restenosis caused by drug-eluting stents is extremely difficult to treat. If drug-eluting stents are inserted again, the probability of secondary restenosis is as high as 43%, and patients treated with drug-eluting stents need to take longer Dual antiplatelet drugs can prevent stent thrombosis; in addition, the therapeutic effect on small blood vessels, bifurcated blood vessels and in situ lesions is not ideal. In recent years, with the increasing incide...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61L29/08A61L29/16
CPCA61L29/08A61L29/085A61L29/16A61L2300/416A61L2300/602A61L2300/606A61L2400/18A61L2420/02A61L2420/08A61M25/1027A61M2025/105C08L29/04C08L67/04C08L69/00C08L71/02
Inventor 张海军周超宋彩霞张军伟冯相蓺
Owner SHANDONG RIENTECH MEDICAL TECH
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