Polymer stent coating stability enhancing sterilization process

A drug coating and polymer technology, applied in irradiation, disinfection and other directions, can solve problems such as reducing drug content, and achieve the effects of increasing drug content, reducing process requirements, and improving stability

Inactive Publication Date: 2017-03-08
SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The electron beam sterilization process in the prior art focuses on the effect of sterilization on the performance of the polymer stent platform. However, in practice, the electron beam sterilization of the polymer stent also has a significant impact on the drug coating, and the conventional process will obviously How to reduce the content of medicine and how to avoid the impact of electron beam sterilization on the medicine coating is a difficult problem that the present invention considers to solve

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The PLGA material is processed and shaped, the molecular weight of polylactic acid-glycolic acid copolymer (PLGA) is 75000, LA: GA=85%: 15%, in which lactic acid and glycolic acid mole percentage, is prepared into a biodegradable PLGA scaffold, by Coating machine spraying, the mass ratio of rapamycin to the coating carrier is 1:2, the coating thickness is 5 μm, the coating carrier is the same as the stent material, dried in a vacuum oven, and finally the drug-eluting stent and the desiccant are covered with paper Packed in a plastic bag, and then sealed in an aluminum foil bag. During the packaging process, the amount of nitrogen gas is filled quantitatively through a nitrogen flow meter, which is about 200 times the thickness of the aluminum foil bag. radiation doses to sterilize drug-eluting stents. After sterilization, the drug stent is taken out, and the drug content is detected by HPLC.

[0035] The drug content of the drug-eluting stent is compared with that befo...

Embodiment 2

[0038] The PLGA material is processed and shaped, the molecular weight of polylactic acid-glycolic acid copolymer (PLGA) is 75000, LA: GA=85%: 15%, in which lactic acid and glycolic acid mole percentage, is prepared into a biodegradable PLGA scaffold, by Coating machine spraying, the mass ratio of rapamycin to the coating carrier is 1:2, the coating thickness is 5 μm, the coating carrier is the same as the stent material, dried in a vacuum oven, and finally the drug-eluting stent is mixed with a desiccant and a deoxidizer Pack them together in a paper-plastic bag, and then seal them in an aluminum foil bag. During the packing process, the amount of nitrogen gas is filled quantitatively through a nitrogen flow meter, which is about 125 times the thickness of the aluminum foil bag, and the sterilization time is about 30 minutes. The drug-eluting stents were sterilized with a radiation dose of 15 kGy. After sterilization, the drug stent is taken out, and the drug content on the d...

Embodiment 3

[0042] The PLGA material is processed and shaped, the molecular weight of polylactic acid-glycolic acid copolymer (PLGA) is 75000, LA: GA=50%: 50%, in which lactic acid and glycolic acid are prepared as biodegradable PLGA scaffolds by Coating machine spraying, the mass ratio of rapamycin to the coating carrier is 1:3, the coating thickness is 5 μm, the coating carrier is the same as the stent material, dried in a vacuum oven, and finally the drug-eluting stent is mixed with a desiccant and a deoxidizer Pack them together in a paper-plastic bag, and then seal them in an aluminum foil bag. During the packing process, nitrogen gas is filled quantitatively through a nitrogen flow meter, which is about 150 times the thickness of the aluminum foil bag. The sterilization time is about 20 minutes. The drug-eluting stents were sterilized with a radiation dose of 15 kGy. After sterilization, the drug stent is taken out, and the drug content on the drug stent is determined by HPLC.

[0...

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Abstract

The invention provides a polymer stent coating stability enhancing sterilization process, comprising the steps of getting biodegradable polymers and working to prepare into a biodegradable stent, coating to prepare into a drug elution stent, the drug being rapamycin, after being dried, holding to a balloon catheter, together with a drying agent and a deoxidizing agent being placed into a paper plastic bag to pack, using an aluminum foil bag sealing for the outer package, in the packaging process through an air flow meter set filling in the outer package an proper amount of idle gas, and conducting radioactive sterilization. The process can obviously lower the drug germinated degradation on the stent, thereby increasing the drug content on the drug elution tent, the process does not require increasing the thickness of the coating layer to reach the target drug load content.

Description

technical field [0001] The invention belongs to the technical field of implantable medical devices, in particular to a sterilization process for improving the stability of a polymer stent drug coating. Background technique [0002] The invention relates to a radially expandable tubular device which can be implanted in the human body cavity, as well as its material and preparation method. "Tubular device" refers to an artificial device that can be implanted into the lumen of the human body; "lumen" refers to the cavity of a tubular organ, such as a blood vessel. A stent is one of the above-mentioned tubular devices, and a "stent" is usually a cylindrical device used to keep a specific section of blood vessel open or stretch it apart to treat blood vessel narrowing caused by disease. "Stenosis" refers to the contraction and reduction of the inner diameter of the tubular organ cavity in the human body. In stenting therapy, stents are used to support the tubular lumen and prev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/08
CPCA61L2/08A61L2/081A61L2/082A61L2/087A61L2202/24
Inventor 蔡桢华胡晓露高康荣
Owner SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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