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Biodegradable polymer support storing method

A technology of biological and packaging bags, which is applied in the storage field of biodegradable stents, can solve the problems of long cooling time, inability to maintain cooling gas, and no significant improvement in storage stability of stents, so as to achieve improved stability, improved sterilization and storage environmental effects

Active Publication Date: 2014-06-25
SHANGHAI MICROPORT MEDICAL (GROUP) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method can eliminate the stress during the preparation of the scaffold to a certain extent, but it cannot solve the problem of poor storage stability of the scaffold caused by the free radicals generated during the sterilization of the scaffold.
[0011] U.S. Patent Application No. 2008010947A1 discloses that the stent is placed in a closed cavity, and the closed cavity is filled with cooling gas such as dry ice or liquid nitrogen for low-temperature (below 0°C) irradiation sterilization. This method has a significant cooling effect, but the cooling gas The cooling time cannot be maintained for a long time, the aging time caused by the free radicals generated by the material radiation is long, and the storage stability of the bracket is not significantly improved

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0029] The polylactic acid material is processed into a biodegradable polylactic acid scaffold (PLA scaffold). Combine the PLA scaffold with a deoxidizer ( KD-20), desiccant They are sealed and packaged together in an aluminum foil bag, and the air is removed during the packaging process and filled with nitrogen. The capacity of the aluminum foil bag is about 1000ml, and the outside of the aluminum foil bag is covered with an ice bed. The PLA scaffold is sterilized under a radiation dose of 15kGy, and the scaffold is taken out from the ice bed after sterilization.

[0030] After the PLA stent was stored at room temperature for 6 months, the stent was taken out of the aluminum foil bag, and the radial extrusion resistance and radial retraction performance of the stent were tested. Compared with before sterilization, the radial anti-extrusion performance of the stent decreased by about 5.2%, the radial retraction performance decreased by about 4.5%, and the performance of th...

Embodiment 2

[0032] The PLGA material is processed into a biodegradable PLGA scaffold. The PLGA stent, deoxidizer (ascorbic acid), and desiccant (molecular sieve) are sealed and packaged in an aluminum foil bag. During the packaging process, the air is removed and filled with helium. The capacity of the aluminum foil bag is about 1000ml, and the outside of the aluminum foil bag is covered with a chemical ice pack. The PLGA scaffold is sterilized at a radiation dose of 25kGy. After sterilization, the PLGA scaffold is taken out of the chemical ice pack.

[0033] PLGA was stored at room temperature for 8 months, and the stent was taken out of the aluminum foil bag, and the radial extrusion resistance and radial retraction performance of the stent were tested. Compared with before sterilization, the radial anti-extrusion performance of the stent decreased by about 10.5%, the radial retraction performance decreased by about 8.2%, and the performance of the stent remained basically stable.

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Abstract

The invention relates to the field of medical instruments, in particular to a biodegradable polymer support storing method. The method includes packaging the biodegradable polymer support and one or both of deoxidizer and desiccant in a sealed manner through an airtight package bag, then performing radiation sterilization, and accordingly improving stability of the biodegradable polymer support is improved.

Description

technical field [0001] The invention relates to the field of medical instruments. Specifically, the present invention relates to a storage method for a biodegradable scaffold, which aims to improve the stability of the biodegradable scaffold. Background technique [0002] As an important device for the treatment of vascular stenosis, stent has been widely used in the field of cardiovascular diseases. However, metal stents, which are widely used in clinical practice at present, will permanently remain in the human body after completing the treatment task, which will weaken MRI or CT images of coronary arteries, interfere with surgical revascularization, hinder the formation of collateral circulation, and inhibit the positive reactivity of blood vessels. Plastic and other defects. Based on these problems, biodegradable scaffolds have attracted much attention as a possible alternative solution. [0003] Biodegradable stents are made of degradable polymer materials or metal m...

Claims

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Application Information

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IPC IPC(8): B65D81/20B65D81/24B65D81/26
CPCY02W90/10
Inventor 陈树国王一涵孟娟罗七一
Owner SHANGHAI MICROPORT MEDICAL (GROUP) CO LTD
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