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Groove carrying-type coating decomposable drug eluting stent

A technology of eluting stents and degrading polymers, which is applied in the field of groove-carrying coating degradable vascular stents, can solve the problems of the risk of coating firmness and safety, weak adhesion performance, poor mechanical properties, etc., and achieve Reduce the risk of coating peeling off, reduce side effects, and avoid the effect of late thrombosis

Active Publication Date: 2010-11-10
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 material of the bracket is cobalt chromium alloy, and the structure is as follows: figure 1 As shown, it consists 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 straight bar section 10 and the transition section (such as 3, 5, 7) are composed, and the outer surface of the unit wave bar has a drug-loading groove 2 that can be loaded with medicine; the width of the straight bar section in the main support unit ring unit wave is 96 μm, and the reinforced The width of the ring is 91 μm; the transition section smoothly connects the straight rod section and the reinforcement ring; the thickness of the scaffold is 100 μm.

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

Embodiment 2

[0046] The bracket body is the same as in Embodiment 1.

[0047] The drug-loading groove is cut out by laser cutting technology, the groove width is 60 μm, the depth is 30 μm, and the cumulative groove length accounts for 60% of the length of the wave rod, and it is processed and sprayed for use.

[0048] Take 0.1g poly-L-lactide (PLLA, the weight average molecular weight range is 20,000-120,000) and 0.1g polyglycolide (PGA, the weight average molecular weight range is 50,000-150,000), and add it to 10ml tetrahydrofuran at room temperature to prepare To a uniform solution, add 0.1 g of paclitaxel and mix evenly, accurately spray the solution into the drug-loading 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 degrade completely within 2 years after completing the function of drug release.

Embodiment 3

[0050] The stent body is the same as in embodiment 1.

[0051] Laser cutting technology is used to cut out the drug-loading groove, the groove width is 55 μm, the depth is 25 μm, and the cumulative groove length accounts for 65% of the length of the wave rod. It is processed and sprayed for use.

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

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

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Abstract

The invention discloses a groove carrying-type coating decomposable drug eluting stent, which comprises a stent main body and a drug coating, wherein the outer surface of the stent main body is provided with a drug-borne groove, the drug coating is coated in the drug-borne groove, and the drug coating comprises a biological decomposable polymer and an active drug. The drug eluting stent not only solves the combination problem between the coating and the stent, and improves the validity and the safety of the drug stent in the operation and application process, but also solves the restenosis and the late thrombosis inside the stent.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a groove-carrying coating degradable vascular stent that can reduce the incidence of in-stent restenosis and late blood vessel thrombosis. 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 (drug-eluting stents, DES) have been widely used. Another milestone in the field of cardiology, ushering in a new era of interventional cardiology. Large-scale randomized, double-blind clinical trials have shown that drug-eluting stents can significantly reduce the incidence of restenosis (restenosis, RS) and major adverse cardiac events (MACE). [0003] At present, the inner and outer metal surfaces of most drug stents are coated with drugs, so that the concentration of drugs in blood vessels is relatively high, and the release rate is relatively fast, and the rel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/82A61M31/00A61L31/08A61L31/16A61L31/14A61L31/10A61L31/02A61F2/91
CPCA61F2230/0054A61L31/16A61L31/148A61L31/10A61F2/91A61F2250/0068
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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