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Coating Process of Drug Coatings on Medical Devices

A medical device and drug coating technology, applied in the field of medical devices, can solve the problems of insufficient bonding force between the drug and the surface of the medical device, insufficient crystal transformation of the drug coating, and insufficient uniformity of drug particle size, etc., so as to improve the release curve, The effect of uniform size and consistent crystal state

Active Publication Date: 2019-06-28
ZHEJIANG BELONGS TO A MEDICAL INSTR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Drug-coated balloons and drug-eluting stents prepared by ultrasonic spraying process have more opportunities to form large-particle drug aggregates on the surface. Such aggregates may block blood vessels during actual use, and their safety has been questioned.
[0010] Aiming at the defects existing in traditional ultrasonic spraying, the Chinese patent application number 201410673301.0 proposes a new coating process, which introduces auxiliary solvent gas during the ultrasonic spraying process, which reduces the chance of re-agglomeration of droplets on the surface of the device. However, this process still has problems such as insufficient crystal transformation of the drug coating on the surface of the medical device, uneven drug particle size, and insufficient binding force between the drug and the surface of the medical device.

Method used

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  • Coating Process of Drug Coatings on Medical Devices
  • Coating Process of Drug Coatings on Medical Devices
  • Coating Process of Drug Coatings on Medical Devices

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Coating process of paclitaxel coating on drug-eluting stent

[0027] 1) Preparation of the spraying solution: Weigh about 0.15g of paclitaxel and add it into a 25ml glass bottle; add 10ml of ethanol into the glass bottle; keep warm in an oven at 45°C until the paclitaxel is completely dissolved.

[0028] 2) Stent coating: place the stent under the ultrasonic spray head, set the ultrasonic frequency to 30khz, the flow rate of the spray solution to 0.05ml / min, and the flow rate of the carrier gas (nitrogen gas) to 2L / min. After spraying, remove the bracket.

[0029] 3) The scaffold is dried at room temperature for 30 minutes.

[0030] 4) Scaffold solvent treatment: place an acetonitrile aqueous solution with a volume fraction of 25% on the lower layer of the container, place the sprayed stent on the upper layer of the container, seal the container and place it in an oven at 25° C., evaporate the acetonitrile aqueous solution to form a steam-filled container, ...

Embodiment 2

[0031] Example 2: Coating process of rapamycin coating on drug-eluting stent

[0032] 1) Preparation of the spraying solution: Weigh about 0.17g of rapamycin and add it into a 25ml glass bottle; add 10ml of ethanol into the glass bottle; keep warm in an oven at 45°C until the rapamycin is completely dissolved.

[0033] 2) Stent coating: place the stent under the ultrasonic spray head, set the ultrasonic frequency to 30khz, the flow rate of the spray solution to 0.05ml / min, and the flow rate of the carrier gas (air) to 2L / min. After spraying, remove the bracket.

[0034] 3) The scaffold is dried at room temperature for 30 minutes.

[0035] 4) Scaffold solvent treatment: place an acetonitrile aqueous solution with a volume fraction of 25% on the lower layer of the container, place the sprayed stent on the upper layer of the container, seal the container and place it in an oven at 20° C., evaporate the acetonitrile aqueous solution to form a steam-filled container, The stent wa...

Embodiment 3

[0036] Embodiment 3: the coating process of paclitaxel coating on drug-coated balloon

[0037] 1) Preparation of the spraying solution: Weigh about 0.15g of paclitaxel and add it into a 25ml glass bottle; add 10ml of ethanol into the glass bottle; keep warm in an oven at 45°C until the paclitaxel is completely dissolved.

[0038] 2) Balloon coating: place the balloon under the ultrasonic spray head, set the ultrasonic frequency to 30khz, the flow rate of the spray solution to 0.05ml / min, and the flow rate of carrier gas (nitrogen) to 2L / min. After spraying, remove the balloon.

[0039] 3) The balloon is dried at room temperature for 30 minutes.

[0040] 4) Balloon solvent treatment: place an acetonitrile aqueous solution with a volume fraction of 25% on the lower layer of the container, place the sprayed balloon on the upper layer of the container, seal the container and place it in an oven at 30° C., evaporate the acetonitrile aqueous solution to form a vapor filling Containe...

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Abstract

The invention provides a process for coating a medicine coating on a medical apparatus. The method comprises the steps of leading a carrier gas in to perform ultrasonic spray on the medical apparatus to form the medicine coating on the surface of the medical apparatus; after ultrasonic spray, utilizing an auxiliary solvent gas to recrystallize the medicine coating on the surface of the medical apparatus; wherein the auxiliary solvent gas is steam formed after mixed solution of water and an organic solvent evaporates; and the organic solvent is one or two or more selected from a group consisting of dioxin, dimethylformamide, dimethyl sulfoxide, N- methyl-2-pyrrolidone, acetonitrile, N,N- dimethylacetamide, tetrahydrofuran, acetone, methanol, ethanol, butanol and n-heptane. The medicine coating is recrystallized after the medicine coating is formed, the crystal type transform is more sufficient, the medicine particle is uniform in size, the coating granularity is greatly reduced, the binding force between the coating and the surface of the medical apparatus is increased, the loss of the medicine coating is small during pressing and holding, and the medicine effect is longer. The process is an effective process sitable for a carrier-free medicine coating support.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a coating process of a drug coating on a medical device. Background technique [0002] With the widespread application of endovascular intervention or implantation, the subsequent postoperative vascular restenosis has attracted more and more attention. Studies have shown that there are different factors that cause intravascular restenosis, such as vascular intimal injury, thrombosis, inflammation, healing, genes, etc., but the currently recognized formation mechanisms include elastic recoil of the vessel wall after vasodilation and thrombosis. , the excessive proliferation and migration of vascular smooth muscle cells (VSMC) induced by injury to the intima played a key role. In recent years, a variety of interventional or implantable medical devices containing drug coatings have been developed for various mechanisms of intravascular restenosis. Drug-coated balloons and ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/16
CPCA61L31/16A61L2300/216A61L2300/416A61L2300/602A61L2300/606A61L2420/02
Inventor 赵中常婷
Owner ZHEJIANG BELONGS TO A MEDICAL INSTR
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