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2. 发明公开

EP1632254A1 Method of coating stents 失效转让
标题翻译： Verfahren zur Beschichtung von支架
公开(公告)号：EP1632254A1
公开(公告)日：2006-03-08
申请号：EP05254517.5
申请日：2005-07-20
申请人： Cordis Corporation
发明人： Akerman, Eugena A. , Cleeren, Dirk , Llanos, Gerard , Maryanoff, Cynthia A. , Papandreou, Georgios , Rion, William L. , Six, Karel , Todd, Thomas L.
IPC分类号： A61L27/34 , A61L27/54 , A61L31/10 , A61L31/16
CPC分类号： A61L27/34 , A61L27/54 , A61L31/10 , A61L31/16 , A61L2300/604 , A61L2420/08 , C08L65/04
摘要： An improved process for coating implantable medical devices utilizes a number of techniques for improving the stability of therapeutic agents contained within the coating.
In one embodiment, the process comprises:

(a) applying a primer coating on the implantable medical devices, including the application of a parylene layer and annealing the parylene layer to reduce autoxidation initiators;
(b) preparing a basecoat solution comprising polymers and a therapeutic agent and applying the basecoat solution to the implantable medical devices coated with parylene, the basecoat solution being prepared with and applied utilizing a process to reduce the presence and exposure of the basecoat solution to oxygen, raising the glass transition temperature of the therapeutic agent and creating a coating morphology to protect the therapeutic agent from autoxidation;
(c) preparing a topcoat solution comprising at least one polymer and applying the topcoat solution to the implantable medical devices coated with the basecoat solution, the topcoat solution being prepared with and applied utilizing a process to reduce the presence and exposure of the topcoat solution to oxygen, raising the glass transition temperature of the therapeutic agent and creating a coating morphology to protect the therapeutic agent from autoxidation; and
(d) finally processing the implantable medical devices, including inspecting, packaging and sterilizing the coated medical devices, the final processing including protecting the therapeutic agent from autoxidation, reducing the presence of and exposure of all materials to five radicals and reducing the presence of and exposure of all materials to oxygen.
摘要翻译：用于涂覆可植入医疗装置的改进方法利用许多技术来改善包含在涂层内的治疗剂的稳定性。在一个实施方案中，该方法包括：（a）在可植入医疗装置上施加底漆涂层，包括施加聚对二甲苯层并退火聚对二甲苯层以减少自动氧化引发剂; （b）制备包含聚合物和治疗剂的底涂层溶液，并将底涂层溶液施用于用聚对二甲苯涂覆的可植入医疗装置，所述底漆溶液通过使用并利用将底漆溶液存在和暴露于氧气的方法制备和应用提高治疗剂的玻璃化转变温度并产生涂层形态以保护治疗剂免于自动氧化; （c）制备包含至少一种聚合物的面漆溶液并将外涂层溶液涂覆到涂覆有底涂层溶液的可植入医疗装置上，所述面漆溶液通过制备并施加，以减少面漆溶液的存在和暴露于氧，提高治疗剂的玻璃化转变温度并产生涂层形态以保护治疗剂免于自氧化; （d）最后处理可植入医疗器械，包括检查，包装和消毒涂覆的医疗器械，最终加工包括保护治疗剂免于自动氧化，减少所有材料的存在和暴露于五个自由基，并减少并将所有材料暴露于氧气。

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