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    • 1. 发明授权
    • Rotational atherectomy device
    • 旋转粥样斑块切除装置
    • US06217595B1
    • 2001-04-17
    • US09225370
    • 1999-01-04
    • Leonid ShturmanAndrei Nevzorov
    • Leonid ShturmanAndrei Nevzorov
    • A61B1700
    • A61B17/320758A61B2017/00685A61B2017/320004A61B2090/3782
    • A method of forming an elongate, flexible drive shaft which has utility as a rotational atherectomy device. In accordance with this method, an inner helical coil having a lumen and a proximal end is formed by winding a plurality of wires about a forming mandrel. An outer helical coil having a lumen and a proximal end is formed by winding a single wire with a mandrel-less coil forming machine. The inner helical coil is positioned within the outer helical coil to define a drive shaft. The inner and outer helical coils are oriented such that the inner helical coil is wound in a direction opposite that in which the outer helical coil is wound.
    • 一种形成细长的柔性驱动轴的方法,该驱动轴具有用作旋转地球切除装置的功能。 根据该方法,通过围绕成形心轴缠绕多条线来形成具有内腔和近端的内螺旋线圈。 具有内腔和近端的外螺旋线圈通过用无芯线圈成形机缠绕单线而形成。 内螺旋线圈位于外螺旋线圈内以限定驱动轴。 内螺旋线圈和外螺旋线圈被定向为使得内螺旋线圈沿与外螺旋线圈缠绕的方向相反的方向缠绕。
    • 3. 发明授权
    • Rotational atherectomy device
    • 旋转粥样斑块切除装置
    • US06295712B1
    • 2001-10-02
    • US09597959
    • 2000-06-20
    • Leonid ShturmanAndrei Nevzorov
    • Leonid ShturmanAndrei Nevzorov
    • B23P1700
    • A61B17/320758A61B2017/320008Y10T29/4981
    • An atherectomy device for removing tissue from an artery. The device includes a flexible, elongated drive shaft rotatable about a guide wire, the drive shaft having an enlarged diameter tissue removal section. The drive shaft and the enlarged diameter tissue removal section are comprised of helically wound wire. Wire turns of the proximal portion of the tissue removal section have diameters that gradually increase distally at a generally constant rate thereby forming generally the shape of a cone. Wire turns of the distal portion of the enlarged diameter tissue removal section have diameters that gradually decrease distally thereby forming a generally convex distal portion. At least part of the tissue removal section includes an external coating of an abrasive material to define an abrasive segment of the drive shaft. The drive shaft may include a reduced diameter segment located near the enlarged diameter tissue removal section to facilitate smooth rotation of the drive shaft and its tissue removal section about the guide wire when the atherectomy device is rotated at high speeds. Preferably such a reduced diameter segment is provided just proximal to the enlarged diameter tissue removal section, and preferably the entire portion of the drive shaft distal to the enlarged diameter tissue removal section also has a similarly reduced diameter. The maximum outer diameter and length of the abrasive segment may be selected so that, at operational rotational speeds and under load, at least some of the wire turns of the proximal portion of the enlarged diameter tissue removal section unwind from their at-rest diameter to an effective outer diameter which is the same as or larger than the maximum outer diameter of the abrasive segment.
    • 用于从动脉去除组织的粥样斑块切除装置。 该装置包括可围绕导丝线旋转的柔性细长的驱动轴,该驱动轴具有扩大的直径的组织去除部分。 驱动轴和扩大直径的组织去除部分由螺旋缠绕的线组成。 组织去除部分的近端部分的线匝具有以大致恒定的速度向远端逐渐增加的直径,从而形成锥体的大致形状。 放大直径的组织去除部分的远端部分的线匝具有在远端逐渐减小的直径,从而形成大致凸起的远端部分。 组织去除部分的至少一部分包括研磨材料的外部涂层以限定驱动轴的研磨部分。 驱动轴可以包括位于扩大直径的组织移除部分附近的减小直径的部分,以便当粥样斑块切除装置高速旋转时,驱动轴及其组织移除部分围绕导丝的平滑旋转。 优选地,这种直径减小的部分设置在较大直径的组织移除部分的近侧,优选地,远离扩大的直径组织移除部分的驱动轴的整个部分也具有相似的直径减小。 可以选择研磨部分的最大外径和长度,使得在操作旋转速度和负载下,扩大直径的组织移除部分的近侧部分的至少一些线匝从其静止直径展开到 与磨料段的最大外径相同或更大的有效外径。
    • 4. 发明授权
    • Eccentric drive shaft for atherectomy device and method for manufacture
    • 用于粥样斑块切除装置的偏心驱动轴及其制造方法
    • US06638288B1
    • 2003-10-28
    • US09552739
    • 2000-04-18
    • Leonid ShturmanAndrei NevzorovMikhail Spassky
    • Leonid ShturmanAndrei NevzorovMikhail Spassky
    • A61D102
    • A61B17/320758A61B17/320725A61B2017/00526A61B2017/00553A61B2017/00853A61B2017/22039A61B2017/320004A61B2017/320766
    • A method of manufacturing a rotational atherectomy drive shaft having an asymmetrical tissue removal section. One or more strands of wire are helically wound about an elongated mandrel having an enlarged diameter section with a predetermined shape, thereby forming an elongated, flexible drive shaft which has an enlarged diameter tissue removal section. A portion of the drive shaft, including the enlarged diameter tissue removal section, is placed into a first clamp and given a first heat treatment to give the wire turns of the enlarged diameter tissue removal section an initial set, thereby preserving the initial shape of the enlarged diameter tissue removal section of the drive shaft. The drive shaft is then removed from the first clamp and the mandrel is dissolved. The enlarged diameter section of the drive shaft is then deformed to an asymmetrical shape by placing a portion of the drive shaft, including the enlarged diameter tissue removal section, into a second clamp. The clamped portion of the drive shaft is then heat treated for a second time to give wire turns of the enlarged diameter tissue removal section a new set, thereby preserving the asymmetrical shape of the enlarged diameter section. In its asymmetrical shape the enlarged diameter tissue removal section has a longitudinally flat “side”—i.e., all wire turns of the tissue removal section may be connected by an imaginary straight line which throughout its length is parallel to the rotational axis of the drive shaft.
    • 一种制造具有不对称组织去除部分的旋转粥样斑块切割驱动轴的方法。 将一根或多根绞线缠绕在具有预定形状的具有扩大的直径部分的细长心轴上,从而形成细长的柔性驱动轴,其具有扩大的直径的组织去除部分。 驱动轴的包括扩大的组织去除部分的部分被放置在第一夹具中并进行第一热处理以使扩大直径的组织去除部分的线匝初始设定,从而保持初始形状 驱动轴的直径较大的组织去除部分。 然后将驱动轴从第一夹具中取出并且心轴被溶解。 然后通过将包括扩大的组织去除部分的驱动轴的一部分放置在第二夹具中,使驱动轴的扩大直径部分变形为不对称的形状。 然后将驱动轴的夹紧部分进行第二次热处理,使得扩大直径的组织去除部分的线匝成为新的组,从而保持了扩大直径部分的不对称形状。 在其不对称形状中,扩大直径的组织去除部分具有纵向平坦的“侧面”,组织移除部分的所有线匝可以通过假想直线连接,该假想直线在其整个长度上平行于驱动轴的旋转轴线 。
    • 6. 发明授权
    • Rotational atherectomy device
    • 旋转粥样斑块切除装置
    • US5897566A
    • 1999-04-27
    • US679470
    • 1996-07-15
    • Leonid ShturmanAndrei Nevzorov
    • Leonid ShturmanAndrei Nevzorov
    • A61B17/22A61B17/32
    • A61B17/320758A61B2017/320008Y10T29/4981
    • An atherectomy device for removing tissue from an artery. The device includes a flexible, elongated drive shaft rotatable about a guide wire, the drive shaft having an enlarged diameter tissue removal section. The drive shaft and the enlarged diameter tissue removal section are comprised of helically wound wire. Wire turns of the proximal portion of the tissue removal section have diameters that gradually increase distally at a generally constant rate thereby forming generally the shape of a cone. Wire turns of the distal portion of the enlarged diameter tissue removal section have diameters that gradually decrease distally thereby forming a generally convex distal portion. At least part of the tissue removal section includes an external coating of an abrasive material to define an abrasive segment of the drive shaft. The drive shaft may include a reduced diameter segment located near the enlarged diameter tissue removal section to facilitate smooth rotation of the drive shaft and its tissue removal section about the guide wire when the atherectomy device is rotated at high speeds. Preferably such a reduced diameter segment is provided just proximal to the enlarged diameter tissue removal section, and preferably the entire portion of the drive shaft distal to the enlarged diameter tissue removal section also has a similarly reduced diameter. The maximum outer diameter and length of the abrasive segment may be selected so that, at operational rotational speeds and under load, at least some of the wire turns of the proximal portion of the enlarged diameter tissue removal section unwind from their at-rest diameter to an effective outer diameter which is the same as or larger than the maximum outer diameter of the abrasive segment.
    • 用于从动脉去除组织的粥样斑块切除装置。 该装置包括可围绕导丝线旋转的柔性细长的驱动轴,该驱动轴具有扩大的直径的组织去除部分。 驱动轴和扩大直径的组织去除部分由螺旋缠绕的线组成。 组织去除部分的近端部分的线匝具有以大致恒定的速度向远端逐渐增加的直径,从而形成锥体的大致形状。 放大直径的组织去除部分的远端部分的线匝具有在远端逐渐减小的直径,从而形成大致凸起的远端部分。 组织去除部分的至少一部分包括研磨材料的外部涂层以限定驱动轴的研磨部分。 驱动轴可以包括位于扩大直径的组织移除部分附近的减小直径的部分,以便当粥样斑块切除装置高速旋转时,驱动轴及其组织移除部分围绕导丝的平滑旋转。 优选地,这种直径减小的部分设置在较大直径的组织移除部分的近侧,优选地,远离扩大的直径组织移除部分的驱动轴的整个部分也具有相似的直径减小。 可以选择研磨部分的最大外径和长度,使得在操作旋转速度和负载下,扩大直径的组织移除部分的近侧部分的至少一些线匝从其静止直径展开到 与磨料段的最大外径相同或更大的有效外径。