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Groove carrying-type coating decomposable drug eluting stent

A technology for eluting stents and degrading polymers, which is applied in the field of groove-carrying coating degradable vascular stents, can solve problems such as poor mechanical properties, risk of coating firmness and safety, weak adhesion performance, etc., to achieve Reduce side effects, reduce the risk of coating peeling, enhance the effect of controlled release ability

Active Publication Date: 2014-07-09
SHANGHAI MICROPORT MEDICAL (GROUP) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although polylactic acid has good biological properties and degradation properties, because the material itself is brittle, hard and brittle, and its mechanical properties are poor, there are still certain difficulties in replacing the stent body (such as the metal stent body) as a drug carrier and supporting blood vessels; Using the traditional method of full coating on the inner and outer surfaces of metal, and because of its weak adhesion to the metal surface, there is a certain safety risk in the firmness of the coating

Method used

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  • Groove carrying-type coating decomposable drug eluting stent
  • Groove carrying-type coating decomposable drug eluting stent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The bracket is made of cobalt-chromium alloy, the structure is like figure 1 As shown, it is composed of a plurality of main support unit rings 1, 8 and connecting rods 4, 6 connecting the unit rings. The main support unit ring is composed of a plurality of unit waves; the unit waves are composed of a circular arc section of a reinforcing ring 9 and a wave rod section The straight rod section 10 and the transition section (such as 3, 5, 7) are composed of the straight bar section (such as 3, 5, and 7). The outer surface of the unit wave bar is opened with a drug-carrying groove 2 that can be loaded with medicine; The ring width is 91μm; the transition section smoothly connects the straight rod section and the reinforcing ring; the stent thickness is 100μm.

[0042] The drug-carrying groove is cut by laser cutting technology. The groove width is 60 μm and the depth is 30 μm. The cumulative groove length accounts for 60% of the total pole length of the main support unit ring....

Embodiment 2

[0046] The stent body is the same as in the first embodiment.

[0047] The drug-carrying groove is cut by laser cutting technology. The groove width is 60 μm and the depth is 30 μm. The cumulative groove length accounts for 60% of the length of the wave rod. After processing, spraying is ready for use.

[0048] Take 0.1g poly L-lactide (PLLA, weight average molecular weight range of 20,000-120,000) and 0.1g polyglycolide (PGA, weight average molecular weight range of 50,000-150,000), add 10ml tetrahydrofuran at room temperature to prepare Add 0.1g of paclitaxel to the uniform solution and mix it evenly, spray the solution accurately into the drug-carrying tank of the stent, dry the stent in a vacuum oven, and sterilize it with ethylene oxide for use. The poly-L-lactide used in Example 2 will be completely degraded within 2 years after completing the function of drug release.

Embodiment 3

[0050] The stent body is the same as in the first embodiment.

[0051] The drug-carrying groove is cut by laser cutting technology. The groove width is 55 μm and the depth is 25 μm. The cumulative groove length accounts for 65% of the length of the wave rod. After processing, spraying is ready for use.

[0052] Take 0.2g of polyglycolide-lactide (PLGA, weight average molecular weight range is 40,000-150,000), add 10ml of tetrahydrofuran at room temperature to make a uniform solution, then add 0.1g of rapamycin and mix it evenly. Spray accurately into the drug-carrying tank of the stent, dry the stent in a vacuum oven, and sterilize with ethylene oxide for use.

[0053] The polyglycolide-lactide used in Example 3 will be completely degraded within 2 years after completing the function of drug release.

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Abstract

A drug-eluting stent with a carrying groove and a degradable coating includes a stent body and a drug coating (11). The external surface of the stent body is provided with a drug carrying groove (2), and the drug carrying groove (2) is coated by the drug coating (11) therein. The drug coating (11) includes biodegradable polymers and active drugs.

Description

Technical field [0001] The invention relates to the field of medical devices, in particular to a groove-carrying coating degradable blood vessel stent that can reduce the incidence of restenosis and blood vessel late thrombosis in a stent. Background technique [0002] Cardiovascular disease is an important disease that affects human health. Since the Cypher stent was approved by the US FDA in 2003, drug-eluting stents (DES) have been widely used and are known as interventional heart disease after bare metal stents. Another milestone in the field of science, ushered in a new era of interventional cardiology. Large-scale randomized, double-blind clinical trials have shown that drug-eluting stents can significantly reduce the occurrence of in-stent restenosis (RS) and major adverse cardiac events (MACE). [0003] At present, the metal inner and outer surfaces of most drug stents are coated with drugs, so that the concentration of the drugs in the blood vessels is relatively large, t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F2/91A61M31/00A61L31/08A61L31/16A61L31/14A61L31/10A61L31/02
CPCA61F2/91A61F2230/0054A61L31/148A61L31/16A61L31/10A61F2250/0068
Inventor 吴常生张劼易博唐智荣罗七一
Owner SHANGHAI MICROPORT MEDICAL (GROUP) CO LTD
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