Stainless steel cardiovascular bracket with pharmaceutical coating on surface and preparation method thereof

Abstract

The invention discloses a 316L stainless cardiovascular stent with a hybrid medicament smear layer and its preparation method. The hybrid medicament smear layer consists of non-biodegradation elastomer, anti-hyperplasia agent, and anti-thrombus agent. Wherein, the inner layer is made up of non-biodegradation elastomer and medicaments with anti-hyperplasia effect, and the outer layer is made up of non-biodegradation elastomer and medicaments with anti- thrombus effect. The preparation process of the smear layer is that: firstly prepare the non-biodegradation elastomer, the anti-hyperplasia hybrid medicament smear layer, and the non-biodegradation elastomer smear layer orderly on the surface of the stent, and finally, use plasma technology to initiate grafting anti-thrombus medicament on the surface of the outer layer of non-biodegradation elastomer.

Description

technical field [0001] The invention relates to an interventional medical appliance, in particular to a stainless steel bracket with drug coating on the surface for interventional treatment of human coronary heart disease and a preparation method thereof. Background technique [0002] Percutaneous transluminal coronary angioplasty (PTCA) has become one of the commonly used clinical methods for the treatment of coronary heart disease due to its advantages such as no need for thoracotomy, high success rate, small trauma, no need for general anesthesia, convenience and speed, etc. one. However, a large number of clinical application results show that after balloon dilation, the restenosis rate after PTCA is as high as 30% to 50% due to factors such as acute atresia and elastic retraction of the vessel wall, abnormal vascular reconstruction, and tissue proliferation. 3 to 6 months after operation. [0003] In 1987, Sigwart et al. used intravascular metal stents for coronary ar...

AI Technical Summary

Problems solved by technology

However, since the stent cannot avoid tissue hyperplasia, coupled with the thrombogenicity of the metal itself, 13% to 20% of restenosis still occurs after stent implantation.

It can be seen that although coronary stents can reduce the occurrence of vascular restenosis after PTCA to a certain extent, their clinical application still faces the following problems: 1) subacute thrombosis (within 10 days after surgery); 2) delayed thrombosis ;3) Hyperplasia of intima and media caused by excessive proliferation and migration of smooth muscle cells (peak at 14 days and last for about 1 month)

Although this process overcomes the shortcomings of traditional physical blending that is not resistant to body fluid erosion and the introduction of toxic substances in the chemical combination process, the preparation process of heparinized poly(lactic acid-glycolic acid-aspartic acid) is relatively complicated, and the material is degraded. The acidic substance contained in it will stimulate the excessive proliferation of smooth muscle cells, and the anti-proliferation agent (rapamycin) disclosed in the patent is coated on the outermost layer of the stent, and the release rate of rapamycin is difficult to control, which is difficult to meet the clinical needs

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