Completely degradable polymer medicine elution stent and preparation method thereof

A technology for degrading polymers and eluting stents, which is applied in the field of preparation of fully degradable polymer drug-eluting stents, can solve problems such as insufficient mechanical support performance, uneven stent structure, unfavorable polymer flow, etc., and achieve good bioavailability Degradation, absorption, energy absorption, good biocompatibility, and the effect of inhibiting intravascular restenosis

Active Publication Date: 2011-10-12
LEPU MEDICAL TECH (BEIJING) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Existing methods for preparing fully degradable drug-eluting stents mainly include: direct stent injection molding methods, weaving polymer filaments, thermosetting molding, etc., because these preparation methods all require high-precision molds, and due to The mold space is small, and the viscosity of the polymer is high, which is not conducive to the flow of the polymer, so it is easy to cause defects such as uneven scaffold structure and insufficient mechanical support performance

Method used

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  • Completely degradable polymer medicine elution stent and preparation method thereof
  • Completely degradable polymer medicine elution stent and preparation method thereof
  • Completely degradable polymer medicine elution stent and preparation method thereof

Examples

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Effect test

Embodiment 1

[0049] (1) Select L-polylactic acid PLLA with an average molar molecular weight of 200,000 as the scaffold matrix material, heat the material to 200°C in a plastic molding extruder (the melting point of PLLA is 180°C), and wait until the material is completely melted to a uniform state , fill it into the pipe forming mold, the outer diameter of the injection mold is 5mm, the wall thickness is 0.3mm, and slowly cool at a cooling rate of 1°C / min until the internal temperature of the material drops to room temperature, open the mold to remove the pipe from the mold Take it out from the middle to obtain a pipe with an outer diameter of 5 mm and a wall thickness of 0.3 mm. Because the cooling rate is slow enough, the obtained PLLA pipe has high crystallinity and high strength. At the same time, in order to improve the demoulding efficiency of the pipe, a high-temperature silicone ester mold release agent is used.

[0050] (2) Use a laser engraving instrument with a XeCl gas excimer...

Embodiment 2

[0055] (1) The polylactic acid-glycolic acid copolymer PLGA (wherein PLA:PGA is 90%:10%) with an average molar molecular weight of 500,000 is selected as the scaffold matrix material, and the material is heated to 200° C. in a plastic extruder (PLGA The melting point temperature is 180°C). After the material is completely melted to a uniform state, it is extruded from the molding die. The size of the extrusion molding die is 3mm in outer diameter and 0.15mm in wall thickness, and slowly cooled at a cooling rate of 5°C / min, using segmental cooling, the cooling medium is air cooling. That is, a pipe with an outer diameter of 3 mm and a wall thickness of 0.15 mm is obtained.

[0056] (2) Use a laser engraving instrument with a KrF gas excimer laser light source with a wavelength of 248nm to laser engrave a fully degradable polymer tube into a stent, control the power within the range of 0.35W to 0.4W, and have a pulse width of 23ns to obtain the stent matrix .

[0057] (3) Usi...

Embodiment 3

[0061] (1) Select polyglycolic acid PGA with an average molar molecular weight of 300,000 as the scaffold matrix material, and heat the material to 240°C (the melting point of PGA is 230°C) in a plastic molding injection molding machine. After the material is completely melted to a uniform state, Fill it into the pipe forming mold, the outer diameter of the injection mold is 3mm, the wall thickness is 0.2mm, and slowly cool at a cooling rate of 10°C / min until the internal temperature of the material drops to room temperature, open the mold to remove the pipe from the mold Take it out to obtain a pipe with an outer diameter of 3 mm and a wall thickness of 0.2 mm. At the same time, in order to improve the demoulding efficiency of the pipe, a high-temperature silicon ester mold release agent is used.

[0062] (2) Use a laser engraving instrument with a XeCl gas excimer laser source with a wavelength of 308nm to laser engrave a fully degradable polymer tube into a stent. The power ...

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Abstract

The invention relates to a completely degradable polymer medicine elution stent and a preparation method thereof. The stent is prepared from the following steps: 1) processing and forming a degradable polymer material into a pipe; 2) subjecting the pipe to laser engraving to form a stent substrate; 3) polishing the surface of the degradable polymer stent substrate and removing processing defects on the surface of the stent; and 4) forming a medicine carrier coating on the surface of the degradable polymer stent substrate. In the invention, a novel light source is used for implementing the laser engraving of the pipe and the processing defects on the surface of the stent is polished by using a polishing technique, so the obtained stent has high structural stability and can has high mechanical supporting performance; and compared with the conventional method, the method has obvious advantages, the prepared stent has high biocompatibility, can effectively treat diseases such as intravascular stenosis and thrombus, has high positive remodeling effect on blood vessels and can effectively prevent a restenosis in later implanting period of the stent.

Description

technical field [0001] The invention relates to the field of material processing and implantable medical devices, in particular to a preparation method of a fully degradable polymer drug-eluting stent and related products. Background technique [0002] Since the world's first successful PCI operation in 1977, percutaneous coronary intervention has made great progress. The third milestone of interventional therapy for coronary heart disease, the first DES clinical trial results were announced at the Stockholm ESC Annual Conference in Sweden in 2001, proving that DES can significantly reduce in-stent restenosis. In 2002, the application of drug-eluting stents can effectively inhibit intimal hyperplasia and reduce vascular restenosis, and its clinical effect is encouraging. However, as time goes by, it is found that the long-term restenosis rate of DES has not been reduced as expected, especially the late thrombosis in the stent, which can reach 30%-40%. In 2006, there was ev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/82A61M31/00B29C41/14B29C41/52B29C45/76B29C47/92A61L31/06A61L31/16A61F2/91B29C48/92
Inventor 赵昆张正才蒲忠杰张艳龙李畅李颖王洪建
Owner LEPU MEDICAL TECH (BEIJING) CO LTD
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