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

A drug coating and cardiovascular technology, which is used in drug devices, medical preparations containing active ingredients, blood vessels, etc., can solve the complex preparation process of heparinized polymerization, difficult to control the release rate of rapamycin, and difficult to meet clinical requirements. It can prevent the occurrence of subacute and long-term thrombosis, improve hydrophilicity and biocompatibility, and promote adhesion and growth.

Active Publication Date: 2005-01-26
SHANGHAI REBONE BIOMATERIALS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 sho

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Take the 316L stainless steel bracket, wash and dry it. The above-mentioned stent was immersed in a solution containing 0.00004 g of paclitaxel, 0.40 g of ethylene-vinyl acetate, and 7.59 g of toluene for 30 seconds, taken out, and dried under vacuum at 60° C. for 20 hours. The stent was then immersed in a solution containing 0.2 g of ethylene-vinyl acetate and 9.8 g of toluene for 30 seconds, taken out and dried. Heparin grafting was initiated using a nitrogen plasma. The plasma treatment conditions are: RF power 20w, vacuum degree 50Pa, time 10min. Pass through 4% heparin aqueous solution for 30 minutes, and after drying, the surface heparin grafting amount is 5.3ug / cm 2 drug stent, which is denoted as TH-1. The polymer coating has a smooth, transparent surface and is firmly bonded to the substrate. Among them, the release rate of antiproliferative drugs is shown in the attached image 3 , after drug release, the amount of heparin on the surface of the stent was ...

Embodiment 2

[0058] Take the 316L stainless steel bracket, wash it, and dry it. The above-mentioned stent was immersed in a solution containing 0.02 g of paclitaxel, 0.18 g of ethylene-vinyl acetate, and 7.8 g of toluene for 100 seconds, taken out, and dried. Then dip the stent in a solution containing 0.1 g of ethylene-vinyl acetate and 9.9 g of toluene for 30 seconds, take it out, and dry it. Nitrogen plasma was used to initiate heparin grafting, and the plasma treatment conditions were: radio frequency power 100w, vacuum degree 10Pa, time 2min. Pass through 4% heparin aqueous solution for 10 minutes, and the grafted heparin amount after drying is 5.1ug / cm 2 The drug stent, the stent is recorded as TH-2. The polymer coating has a smooth, transparent surface and is firmly bonded to the substrate. Among them, the release rate of antiproliferative drugs is shown in the attached image 3 . After the drug release, the amount of residual heparin on the surface of the stent was 4.2ug / cm 2...

Embodiment 3

[0060] Take the 316L stainless steel bracket, wash and dry it. Spray 20 grams of a toluene solution containing 0.002 grams of paclitaxel and 0.198 grams of propylene-vinyl acetate on the surface of the stent and dry it. The stent was then dipped in a solution containing 0.2 g of ethylene-methyl methacrylate and 9.8 g of toluene, taken out, and dried. Heparin grafting was initiated using oxygen plasma. The plasma treatment conditions are: RF power 500w, vacuum degree 100Pa, time 10min. Pass through 4% heparin aqueous solution for 15 minutes, and the content after drying is 3.2ug / cm 2 The heparin drug stent, the stent is recorded as TH-3. The polymer coating has a smooth, transparent surface and is firmly bonded to the substrate. Among them, the release rate of antiproliferative drugs is shown in the attached image 3 . After the drug release, the amount of residual heparin on the surface of the stent was 2.8ug / cm 2 .

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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...

Claims

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Application Information

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IPC IPC(8): A61F2/06A61K31/337A61K31/573A61K38/13A61M29/00A61M31/00
Inventor 刘昌胜袁媛
Owner SHANGHAI REBONE BIOMATERIALS
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