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    • 2. 发明授权
    • Medical devices having porous polymeric regions for controlled drug delivery and regulated biocompatibility
    • 具有用于受控药物递送和调节的生物相容性的多孔聚合物区域的医疗装置
    • US08535702B2
    • 2013-09-17
    • US11048616
    • 2005-02-01
    • Robert E. RichardFrederick H. StricklerMarlene C. SchwarzRudolf FaustShrirang V. RanadeMichael N. Helmus
    • Robert E. RichardFrederick H. StricklerMarlene C. SchwarzRudolf FaustShrirang V. RanadeMichael N. Helmus
    • A61F2/00
    • A61L31/129A61L27/48A61N1/05
    • The present invention relates to phase separated polymeric regions and to their use in conjunction with implantable or insertable medical devices. In some aspects of the invention, phase separated polymeric regions are provided that include (a) at least one biostable polymeric phase and (b) at least one biodisintegrable polymeric phase, which is of nanoscale dimensions and which undergoes biodisintegration such that the phase separated polymeric region becomes a nanoporous polymeric region in vivo. Other aspects of the invention are directed to methods of making implantable or insertable medical devices having at least one nanoporous polymeric region. These methods include (a) providing a phase separated polymeric region comprising a stable polymeric phase and a disintegrable polymeric phase of nanoscale dimensions, (b) selectively removing the disintegrable polymeric phase thereby producing the nanoporous polymeric region. In still other aspects, implantable or insertable medical devices are provided which have phase separated polymeric regions that include (a) at least one block copolymer having at least one biostable polymer block and at least one biodisintegrable polymer block and (b) at least one therapeutic agent which is released in vivo upon implantation or insertion of the medical device.
    • 本发明涉及相分离的聚合物区域以及它们与可植入或可插入的医疗装置结合使用。 在本发明的一些方面,提供了相分离的聚合物区域,其包括(a)至少一个生物稳定的聚合物相和(b)至少一个具有纳米级尺寸并且经历生物整合的生物分解聚合物相,并且经历相分离的聚合物 区域在体内成为纳米孔聚合物区域。 本发明的其它方面涉及制造具有至少一个纳米多孔聚合物区域的可植入或可插入医疗器械的方法。 这些方法包括(a)提供包含稳定聚合物相和纳米尺度的可分解聚合物相的相分离聚合物区域,(b)选择性地除去可分解的聚合物相,从而制备纳米多孔聚合物区域。 在另外的方面,提供了可植入或可插入的医疗装置,其具有相分离的聚合物区域,其包括(a)至少一种具有至少一种生物稳定聚合物嵌段和至少一种生物可分解聚合物嵌段的嵌段共聚物和(b)至少一种治疗 在植入或插入医疗装置时在体内释放的药剂。
    • 7. 发明授权
    • Multiphase polymeric drug release region
    • 多相聚合物药物释放区
    • US07939094B2
    • 2011-05-10
    • US10175526
    • 2002-06-19
    • Marlene C. SchwarzRobert E. Richard
    • Marlene C. SchwarzRobert E. Richard
    • A61F2/00A61K47/32A61K9/14
    • A61L31/10A61K9/0024A61K31/337A61L31/16A61L2300/602
    • A method is provided for modulating the rate of release of a therapeutic agent from a release region, which constitutes at least a portion of an implantable or insertable medical device and which controls the rate at which the therapeutic is released from the medical device. The method comprises: (a) providing a release region that comprises (i) a therapeutic agent and (ii) polymer composition comprising two or more immiscible phases; and (b) modulating the rate of release of the therapeutic agent by changing the volume that is occupied by at least one of the immiscible polymer phases relative to the total volume of the release region that is formed. The release region can be, for example, a carrier layer, which comprises the therapeutic agent, or a barrier layer, which is disposed over a region that contains the therapeutic agent. In preferred embodiments, the release region is formed by a process comprising: (a) providing a solution comprising (i) a solvent and (ii) the polymer composition; and (b) forming the release region from the solution by removing the solvent from the solution.
    • 提供了一种用于调节治疗剂从释放区域的释放速率的方法,该释放区域构成可植入或可插入的医疗装置的至少一部分并且其控制治疗剂从医疗装置释放的速率。 该方法包括:(a)提供释放区,其包含(i)治疗剂和(ii)包含两个或更多个不混溶相的聚合物组合物; 和(b)相对于形成的释放区域的总体积,通过改变至少一个不混溶的聚合物相占据的体积来调节治疗剂的释放速率。 释放区域可以是例如包含治疗剂的载体层或设置在含有治疗剂的区域上的阻挡层。 在优选的实施方案中,通过包括以下方法形成释放区域:(a)提供包含(i)溶剂和(ii)聚合物组合物的溶液; 和(b)通过从溶液中除去溶剂从溶液中形成释放区。
    • 8. 发明申请
    • IMPLANTABLE OR INSERTABLE MEDICAL DEVICES FOR CONTROLLED DELIVERY OF A THERAPEUTIC AGENT
    • 用于控制输送治疗药物的可植入或插入式医疗装置
    • US20080311173A1
    • 2008-12-18
    • US12192879
    • 2008-08-15
    • Marlene C. SchwarzRobert E. Richard
    • Marlene C. SchwarzRobert E. Richard
    • A61K9/22A61M1/00A61P43/00A61F2/06A61M25/10A61M25/00
    • A61L29/16A61L27/34A61L27/56A61L29/085A61L31/10A61L31/16A61L2300/416A61L2300/602
    • The present invention is directed to novel implantable or insertable medical devices that provide release of a therapeutic agent. According to a first aspect of the present invention, a therapeutic-agent-releasing medical device is provided, which comprises: (a) an implantable or insertable medical device; (b) a release layer disposed over at least a portion of the implantable or insertable medical device, and (c) a therapeutic agent. The release layer regulates the rate of release of the therapeutic agent from the medical device upon implantation or insertion of the device into a patient. The release layer comprises (i) a first polymer comprising one or more polymer chains that form one or more polymer phase domains when the first polymer is in a pure solid-state form; and (ii) a second polymer comprising two or more polymer chains that form two or more phase domains when the second polymer is in a pure solid-state form. The first and second polymers are preferably selected such that at least one polymer chain in the second polymer is compatible with at least one polymer chain in the first polymer. The present invention is also directed to methods of forming the above implantable or insertable medical devices, methods of administering a therapeutic agent to a patient using such devices, and methods of modulating the release of therapeutic agents from implantable or insertable medical devices.
    • 本发明涉及提供治疗剂释放的新型可植入或可插入的医疗装置。 根据本发明的第一方面,提供了一种治疗剂释放医疗装置,其包括:(a)可植入或可插入的医疗装置; (b)设置在所述可植入或可插入医疗装置的至少一部分上的释放层,和(c)治疗剂。 释放层调节在将装置植入或插入患者体内治疗剂从医疗装置释放的速率。 释放层包含(i)第一聚合物,其包含当第一聚合物处于纯固态形式时形成一个或多个聚合物相域的一个或多个聚合物链; 和(ii)当第二聚合物处于纯固态形式时,包含两个或更多个形成两个或多个相域的聚合物链的第二聚合物。 优选选择第一和第二聚合物,使得第二聚合物中的至少一个聚合物链与第一聚合物中的至少一个聚合物链相容。 本发明还涉及形成上述可植入或可插入的医疗装置的方法,使用这种装置向患者施用治疗剂的方法,以及调节治疗剂从可植入或可插入医疗装置释放的方法。