Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Coating process of medicament coating on implantable or interventional medical device

A coating process and technology for medical devices, applied in coatings, medical science, medical containers, etc., can solve problems such as blockage of blood vessels and safety doubts, and achieve the effects of avoiding blood vessel blockage, avoiding thrombosis, and uniform drug coating

Active Publication Date: 2015-02-18
ZHEJIANG BELONGS TO A MEDICAL INSTR
View PDF5 Cites 12 Cited by
  • 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.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Coating process of medicament coating on implantable or interventional medical device
  • Coating process of medicament coating on implantable or interventional medical device
  • Coating process of medicament coating on implantable or interventional medical device

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: Preparation method of paclitaxel drug-coated balloon

[0041] 1) Preparation of spraying solution: Weigh about 0.15g of paclitaxel and 0.3g of PVP into a 25ml glass bottle; add 10ml of acetonitrile into the glass bottle; keep warm in an oven at 45°C until paclitaxel and PVP are completely dissolved.

[0042] 2) Preparation of carrier gas: pass dry high-purity nitrogen through 95% (volume) ethanol / water mixed solution, install a 0.25μm filter membrane at the outlet of the pipeline, and filter fine droplets;

[0043] 3) Balloon coating: place a 4.0mm*60mm balloon under the ultrasonic spray head, set the ultrasonic frequency to 30khz, the flow rate of the spray solution to 0.1ml / min, and the rotation speed of the balloon to 5 r / s. The time is 2min, and the carrier gas flow rate is: 30L / h. After spraying, remove the balloon.

[0044] 4) The balloon was dried at room temperature for 30 minutes.

[0045] 5) Fold the balloon, put it into the coil, pack and ste...

Embodiment 2

[0048] Embodiment 2: Preparation method of rapamycin drug-coated balloon

[0049] 1) Preparation of spraying solution: Weigh about 0.13g rapamycin and 0.3g PVA, add to a 25ml glass bottle; add 10ml of ethanol to the glass bottle, stir to dissolve the drug completely.

[0050] 2) Preparation of carrier gas: pass dry air through 75% (volume) acetonitrile / water mixed solvent, and install a 0.25 μm filter membrane at the outlet of the pipeline to filter fine droplets;

[0051] 3) Balloon coating: place a 4.0mm*60mm balloon under the ultrasonic spray head, set the ultrasonic frequency to 50khz, the flow rate of the spray solution to 0.2ml / min, the rotation speed of the balloon to 10r / s, and the spraying time 1.5min, carrier gas flow rate: 30L / h. After spraying, remove the balloon.

[0052] 4) The balloon was dried at room temperature for 30 minutes.

[0053] 5) Fold the balloon, put it into the coil, pack and sterilize.

[0054]

Embodiment 3

[0055] Embodiment 3: Preparation method of rapamycin drug-coated balloon

[0056] 1) Preparation of spraying solution: Weigh about 0.25g rapamycin and 0.25g PEG into a 25ml glass bottle; add 10ml methanol into the glass bottle and stir to dissolve the drug completely.

[0057] 2) Preparation of carrier gas: pass dry oxygen through water for injection, and install a 0.25μm filter membrane at the outlet of the pipeline to filter fine droplets;

[0058] 3) Balloon coating: place a 4.0mm*60mm balloon under the ultrasonic spray head, set the ultrasonic frequency to 45khz, the flow rate of the spray solution to 0.18ml / min, the balloon rotation speed to 4r / s, and the spraying time 1.2min, carrier gas flow rate: 25L / h. After spraying, remove the balloon.

[0059] 4) The balloon is vacuum dried at 30°C for 20 minutes.

[0060] 5) Fold the balloon, put it into the coil, pack and sterilize.

[0061]

[0062] balloon Coating performance test:

[0063] 1. Test method and result...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
diameteraaaaaaaaaa
Login to View More

Abstract

The invention relates to the technical field of preparation of medical devices, and in particular relates to a coating process of a medicament coating on an implantable or interventional medical device. In the process, a medicament is used for forming a coating on the medical device by using ultrasonic spraying; and in an ultrasonic spraying process, carrier gas is modified to ensure that one or more auxiliary solvent gases which cannot be used for dissolving the medicament are introduced into the carrier gas, so that the medicament is precipitated in a form of micro particles due to the change of solubility after medicament liquid droplets meet the carrier gas, and thus the purpose of reducing the particle size of a final medicament coating can be achieved. The medicament coating formed by using the process disclosed by the invention is uniform, has good affinities with stents or balloon surfaces, and is less in coating falling rate when the medicament coating is folded, pressed or held; and large medicament crystal particles cannot be formed when the medicament coating is immersed in the blood.

Description

[0001] technical field [0002] The invention relates to the technical field of medical device preparation, in particular to a coating process of a drug coating on an implanted or interventional medical device. Background technique [0003] 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 hyperproliferation and migration of vascular smooth muscle cells (VSMC) induced by injury to the intima play a key role. In recent years, a variety of interventional or implantable medical devices containing drug coatings have been developed for various mechanisms of intravascu...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/16A61L31/10A61L29/16A61L29/08A61L33/00
Inventor 常婷季培红颜玉强赵中
Owner ZHEJIANG BELONGS TO A MEDICAL INSTR
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com