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    • 3. 发明授权
    • Coated implantable medical device
    • 涂层可植入医疗器械
    • US06918927B2
    • 2005-07-19
    • US10000659
    • 2001-10-31
    • Brian L. BatesAnthony O. RaghebJoseph M. Stewart, IVWilliam J. BourdeauBrian D. ChoulesJames D. PurdyNeal E. Fearnot
    • Brian L. BatesAnthony O. RaghebJoseph M. Stewart, IVWilliam J. BourdeauBrian D. ChoulesJames D. PurdyNeal E. Fearnot
    • A61L29/00A61F2/00A61F2/86A61K31/337A61K31/4545A61L27/54A61L31/16A61P9/10A61P35/00A61F2/06A61F2/02
    • A61L27/54A61F2/86A61F2250/0067A61L31/16A61L2300/252A61L2300/414A61L2300/606
    • A medical device (10) includes a structure (12) adapted for introduction into a patient, the structure (12) being formed of a preferably non-porous base material (14) having a roughened or textured surface (16). The structure (12) is conveniently configured as a vascular stent with a base material (14) of stainless steel, nitinol or another suitable material. The medical device (10) also includes a layer (18) of a bioactive material posited directly upon the roughened or textured surface (16) of the base material (14) of the structure (12). The surface (16) of the base material (14) is roughened or textured by etching or by abrasion with sodium bicarbonate or another suitable grit. A preferred roughened or textured surface (16) is thought to have a mean surface roughness of about 10 μin. (about 250 nm) and a surface roughness range between about 1 μin. and about 100 μin. (about 25 nm and about 2.5 μm). The particularly preferred use of sodium bicarbonate as the abrasive to provide roughness or texture to the surface (16) of the base material (14) of the structure (12) is additionally advantageous in the low toxicity of the sodium bicarbonate to production workers, the ease of product and waste cleanup, and the biocompatibility of any residual sodium bicarbonate.
    • 医疗装置(10)包括适于引入患者的结构(12),所述结构(12)由具有粗糙或纹理表面(16)的优选无孔基材(14)形成。 结构(12)方便地构造为具有不锈钢,镍钛诺或其它合适材料的基础材料(14)的血管支架。 医疗装置(10)还包括直接位于结构(12)的基底材料(14)的粗糙或纹理表面(16)上的生物活性材料层(18)。 基体材料(14)的表面(16)通过蚀刻或用碳酸氢钠或另一种适当的砂粒磨损而粗糙化或纹理化。 优选的粗糙或纹理表面(16)被认为具有约10μin的平均表面粗糙度。 (约250nm),表面粗糙度介于约1μM之间。 约100多个。 (约25nm和约2.5μm)。 特别优选使用碳酸氢钠作为研磨剂以对结构(12)的基础材料(14)的表面(16)提供粗糙度或织构,另外在碳酸氢钠对生产工人的低毒性方面也是有利的, 易于产品和废物清理,以及任何残留碳酸氢钠的生物相容性。