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    • 46. 发明授权
    • Coated implantable medical device
    • 涂层可植入医疗器械
    • US07846202B2
    • 2010-12-07
    • US11965385
    • 2007-12-27
    • Brian L. BatesAnthony O. RaghebNeal E. FearnotWilliam D. Voorhees, IIIThomas G. Kozma
    • Brian L. BatesAnthony O. RaghebNeal E. FearnotWilliam D. Voorhees, IIIThomas G. Kozma
    • A61F2/06
    • A61F2/885A61F2/0077A61F2250/0068
    • A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, where the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 may be posited over the bioactive material layer 18, where the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.
    • 涂覆的可植入医疗装置10包括适于引入到血管系统,食道,气管,结肠,胆道或尿道中的结构12; 至少一个涂层16位于该结构的一个表面上; 以及至少一层生物活性材料层18,其被定位在涂层16的至少一部分上,其中涂层16提供生物活性材料从涂层的受控释放。 此外,至少一个多孔层20可以位于生物活性材料层18上,其中多孔层包括聚合物,并且通过其提供生物活性材料的受控释放。 优选地,结构12是冠状动脉支架。 多孔层20包括优选通过蒸气或等离子体沉积施加的聚合物,并提供生物活性材料的受控释放。 特别优选的是,聚合物是聚酰胺,聚对二甲苯或聚对二甲苯衍生物,它们不经溶剂,热或催化剂沉积,并且仅通过单体蒸气的冷凝而沉积。
    • 49. 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。
    • 50. 发明授权
    • Coated implantable medical device
    • 涂层可植入医疗器械
    • US06299604B1
    • 2001-10-09
    • US09378541
    • 1999-08-20
    • Anthony O. RaghebBrian L. BatesNeal E. FearnotThomas G. KozmaWilliam D. Voorhees, III
    • Anthony O. RaghebBrian L. BatesNeal E. FearnotThomas G. KozmaWilliam D. Voorhees, III
    • A61M532
    • A61L29/085A61F2250/0068A61L29/16A61L31/10A61L31/16A61L2300/416A61L2300/602A61L2300/608A61L2420/08H01L2924/3025C08L65/04H01L2924/00
    • A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer is includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.
    • 涂覆的可植入医疗装置10包括适于引入到血管系统,食道,气管,结肠,胆道或尿道中的结构12; 至少一个涂层16位于该结构的一个表面上; 和至少一层生物活性物质的层18位于涂层16的至少一部分上,其中涂层16提供生物活性材料从涂层的受控释放。 此外,至少一个多孔层20可以位于生物活性材料层18上,其中多孔层包括聚合物并且提供通过其中的生物活性材料的受控释放。 优选地,结构12是冠状动脉支架。 多孔层20包括优选通过蒸气或等离子体沉积施加的聚合物,并提供生物活性材料的受控释放。 特别优选的是,聚合物是聚酰胺,聚对二甲苯或聚对二甲苯衍生物,它们不经溶剂,热或催化剂沉积,并且仅通过单体蒸气的冷凝而沉积。