Expandable fluoropolymer device and method of making

    公开(公告)号:US07637886B2

    公开(公告)日:2009-12-29

    申请号:US10131396

    申请日:2002-04-22

    IPC分类号: A61M29/00

    摘要: A radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material is described. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body. The monolithic construction of the body and the orientation of the nodes, perpendicular to the longitudinal axis of the body, yields a radially expandable device that predictably and dependably expands to a predefined, fixed maximum diameter that is generally independent of the expansion force used to radially expand the device. In addition, the microstructure of nodes interconnected by fibrils provides at least one predetermined flow rate of fluid therethrough over a range of fluid pressures.

    Application of a therapeutic substance to a tissue location using an expandable medical device
    65.
    发明授权
    Application of a therapeutic substance to a tissue location using an expandable medical device 有权
    使用可扩张医疗装置将治疗物质施用于组织位置

    公开(公告)号:US07572245B2

    公开(公告)日:2009-08-11

    申请号:US10942764

    申请日:2004-09-15

    IPC分类号: A61M31/00

    摘要: A non-polymeric or biological coating applied to radially expandable interventional medical devices provides uniform drug distribution and permeation of the coating and any therapeutic agents mixed therewith into a targeted treatment area within the body. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device. Thus, atraumatic local tissue transference delivery is achieved for uniform therapeutic agent distribution and controlled bio-absorption into the tissue after placement within a patient's body with a non-inflammatory coating.

    摘要翻译: 施加到可径向扩张的介入医疗装置的非聚合或生物涂层提供了涂层和与其混合的任何治疗剂的均匀的药物分布和渗透到体内的目标治疗区域。 涂层是无菌的,并且能够在径向膨胀后由无菌医疗装置携带到身体内的目标组织位置。 治疗涂层部分地由于与组织的生物吸引而部分地转移离开医疗装置,并且部分地从医疗装置到与医疗装置接触的目标组织位置的物理转移。 因此,在用非炎性涂层放置在患者体内之后,实现了不均匀的局部组织转移递送,用于均匀的治疗剂分布和对组织的受控生物吸收。

    Method for treating expandable polymer materials
    66.
    发明授权
    Method for treating expandable polymer materials 有权
    处理可膨胀聚合物材料的方法

    公开(公告)号:US06890463B2

    公开(公告)日:2005-05-10

    申请号:US10131446

    申请日:2002-04-22

    CPC分类号: A61F2/06

    摘要: The invention is directed to methods involving rewetting of expandable polymers with a wettable liquid to allow for enhanced expansion at or below room temperature without breakage, and in some cases, allows one to achieve a greater expansion ratio than that allowed at elevated temperatures using known methods. The wettable liquid can be formed of a drug and/or an agent, such that the resulting polymer contains and emits the drug upon positioning at a target location of a patient body. The present invention also allows one to achieve material with unique properties and handling characteristics. These properties included decreased material thickness, increased density, an altered node/fibril morphology, and a more consistent web in the case of flat material. This method is not limited to room temperature conditions and can be applied whenever the expandable polymer material is wet with a wettable liquid, and the expansion is performed at a temperature preferably below the vaporization or boiling points of that liquid.

    摘要翻译: 本发明涉及包括用可湿性液体再湿润可膨胀聚合物以允许在室温或低于室温下增强膨胀而不破裂的方法,并且在某些情况下允许使用已知方法获得比在升高的温度下更大的膨胀比 。 可湿性液体可以由药物和/或药剂形成,使得所得聚合物在定位在患者身体的目标位置时含有和释放药物。 本发明还可以实现具有独特性质和处理特性的材料。 这些性质包括材料厚度减小,密度增加,节点/原纤维形态改变,以及在平坦材料情况下更一致的网。 该方法不限于室温条件,只要可膨胀聚合物材料用可湿性液体润湿,并且膨胀在优选低于该液体的蒸发或沸点的温度下进行。

    Multi-stage prosthesis
    67.
    发明授权
    Multi-stage prosthesis 有权
    多期假体

    公开(公告)号:US06416537B1

    公开(公告)日:2002-07-09

    申请号:US09604382

    申请日:2000-06-27

    IPC分类号: A61F206

    摘要: A porous tube suitable for use as a vascular graft prosthesis and a method of making it is disclosed. It has a structure of porous polytetrafluoroethylene having a fibrous structure of nodes and fibers connecting the nodes together and an integrated intrawall circumferential support adjacent to areas of variable porosity. This invention provides a polytetrafluoroethylene polymer in a porous form useful as artificial internal organs for, for example vascular bypass, vascular access, and endovascular prosthesis. PTFE walls are found with radial zones of differing porosity are described.

    摘要翻译: 公开了适合用作血管​​移植假体的多孔管及其制造方法。 它具有多孔聚四氟乙烯的结构,其具有连接节点的节点和纤维的纤维结构,以及与可变孔隙度区域相邻的整体的内部周向支撑。 本发明提供一种多孔形式的聚四氟乙烯聚合物,其用作例如血管旁路,血管通路和血管内假体的人造内脏。 发现PTFE壁具有不同孔隙率的径向区域。

    Expandable shielded vessel support
    68.
    发明授权
    Expandable shielded vessel support 有权
    可扩展屏蔽容器支架

    公开(公告)号:US06270523B1

    公开(公告)日:2001-08-07

    申请号:US09419467

    申请日:1999-10-15

    IPC分类号: A61F206

    摘要: A radially expandable support body is enveloped within a cocoon. In a preferred construction, the support is a stent, and a tube of polymeric material, e.g., polytetraeluoroethylene (PTFE), passes through the interior of the stent body and is turned back upon itself over the stent to form a cuff. The assembly is then heated and the outer layer contacts and coalesces with the inner layer, closely surrounding the stent body within a folded envelope having a continuous and seamless end. In one embodiment, an end portion of the tube is expanded before folding back over the-stent. The end portion, which becomes an exterior surface of the finished product, thus acquires a greater degree of porosity. Each end of the central tube may be so expanded, and folded back to seal all surfaces and both ends. The stent body itself may be a ring, or a short series of spaced-apart rings, or a wire or web, or a sheet possessing a number of apertures extending entirely through the sheet. The spaces or apertures are covered over or bridged by both the inner and outer polymer layers. The apertures, which may comprise under five to over eighty percent of the surface area of the stent, constitute regions or a grid of points through which the material is coalesced and continuously bonded, and around which strain is distributed by the support. These points or regions remain tacked together so expansion of the assembly does not delaminate the polymer or create flaps and pockets. In another embodiment, a two tube construction is cuffed and assembled into a similarly unitized and seamless stent. One tube is cuffed back, and the other tube covers the cuffed stent. In this embodiment both the tube thicknesses and porosities may differ substantially. For example the inner porosity may be selected to enhance blood flow or intimal regeneration, and the outer surface may have a porosity to encourage anchoring to external muscle tissue.

    摘要翻译: 径向可扩展的支撑体被包围在茧内。 在优选的结构中,支撑件是支架,并且聚合物材料管例如聚多异氰酸乙烯(PTFE)穿过支架主体的内部并且在其上自我转过支架以形成袖带。 然后将组件加热并且外层与内层接触并聚结,在具有连续和无缝端部的折叠外壳内紧密地围绕支架主体。 在一个实施例中,管的端部在折叠回支架之前膨胀。 成为成品的外表面的端部因此获得更大程度的孔隙率。 中心管的每个端部可以如此膨胀,并且被折回以密封所有表面和两端。 支架主体本身可以是一个环,或一系列间隔开的环,或者线或腹板,或者具有完全贯穿片材的多个孔的片。 空间或孔被内聚合物层和外聚合物层覆盖或桥接。 可以包括支架表面积的五到八十成以上的孔构成区域或网格,通过该点或网格将材料聚结并连续地结合,并且通过支撑分布在哪个应变附近。 这些点或区域保持粘合在一起,因此组件的膨胀不会分解聚合物或产生襟翼和口袋。 在另一个实施例中,将双管结构压合并组装成相似的单元化且无缝的支架。 一根管子被套在后面,另一根管子覆盖着袖口支架。 在该实施例中,管的厚度和孔隙度可能基本上不同。 例如,可以选择内部孔隙率以增强血流或内膜再生,并且外表面可以具有孔隙度以促进锚定到外部肌肉组织。