CN103200886A - 物质移除装置和使用方法 - Google Patents
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Abstract
一种动脉粥样硬化切除导管(2)具有内驱动轴(6),内驱动轴旋转具有螺旋切割表面的远侧旋转组织钻头(7),使得导管能切割经过和穿过CTO。另外,动脉粥样硬化切除导管具有由外驱动轴(3)旋转的远侧切割元件(4),远侧切割元件被构造为当将导管朝远侧推过治疗部位时从治疗部位处的脉管壁上切割物质。动脉粥样硬化切除导管包括定位在切割元件和旋转组织钻头近侧的收集腔(12)。动脉粥样硬化切除导管可以包括引导从治疗部位切下的物质进入收集腔的装置,粉碎可能阻塞或堵塞收集腔的较大物质的装置,以及将从治疗部位收集的物质传送到动脉粥样硬化切除导管上的近侧开口的装置。
Description
本申请要求享有2010年10月28日提交的,题为“物质移除装置和使用方法”的美国临时专利申请No.61/407,788的优先权,通过引用将其所有内容纳入本文。
技术领域
本发明涉及从体腔内的治疗部位移除并收集物质的导管。更具体地,本发明涉及具有双驱动轴的动脉粥样硬化切除导管,所述双驱动轴能穿过脉管内被完全闭塞的治疗部位从而使所述导管能有效地在所述治疗部位处治疗脉管。
背景技术
动脉粥样硬化是一种由于粥样斑块沉积在血管内壁上所导致的脉管系统的进行性疾病。动脉粥样硬化是一种导致胆固醇和其他堵塞物质(已知为斑块)在动脉壁上堆积的复杂、进行性、退化性症状。斑块的堆积使动脉内部或管腔变窄,因此减少了血液流动。
斑块以若干种不同的形式出现在动脉中,并且可能位于整个动脉系统内的多个不同解剖结构中。斑块在组成上是多样的,其具有被称为钙化斑块的硬质和脆质部分,以及多脂的和纤维的其他部分。随着时间推移,粥样化的沉积物会变得足够大从而减少或阻塞经脉管的血液流动,从而导致低血流症状,比如腿疼(在行走时或休息时)、皮肤溃烂、心绞痛(休息时或劳作时),以及其他症状。为了治疗这种疾病以及改善或解除这些症状,需要恢复或改善经脉管的血液流动。
多种手段被用于恢复或改善经粥样化脉管的血液流动。粥样斑块沉积物能通过用充气球囊、膨胀支架和其他方法径向扩张脉管而被移置。这种瘢痕组织(再狭窄物质)在形成之后会阻塞脉管内的流动并经常需要被移除。能通过激光或其他方法粉碎所述沉积物,但是仅粉碎粥样化物质可能使微栓子流到下游并停留在远侧血管床中,从而进一步削弱血液流到受疾病影响的组织。动脉粥样硬化切除导管能被用于从血管移除粥样化沉积物,同时还提供一种理想的解决方案用于捕获从脉管移除的粥样化碎片并将其移出人体。
已经提出了很多类型的动脉粥样硬化切除导管装置,包括带有旋转刺、光学分解组织的激光的导管,以及使用球囊或其他定位装置来将切割器定位在所要移除的物质附近的导管。
另外,某些导管具有定位在切割窗口远侧的收集腔。这要求切割窗口远侧的导管长度长到足以容纳收集腔。这产生了一些相冲突的设计选择。一方面,期望的是收集腔具有足够大的容积,以在所述腔充满和导管必须取出之前容纳合理数量的被切除物质。另一方面,在某些应用中,容纳足够大的收集腔而增加切割窗口远侧的导管长度是不利的。例如,如果治疗部位或病灶位于具有特别曲折结构或小尺寸的脉管中,在病灶远侧可能没有足够可进入的脉管空间来容纳切割窗口远侧的导管远侧长度。治疗部位远侧的可进入空间有时被称为“停放区”。为了有效地使用导管,脉管结构应当使导管能行进足够远从而将切割窗口定位在治疗部位内,并且将容纳收集腔的导管远侧部分定位在停放区内。所以,具有被定位在切割窗口远侧的收集腔的导管可能难以用在停放区短的脉管中。
在2010年6月14日提交的共同未决的美国临时专利申请61/354,487(通过引用将其整体纳入本文)中,公开了一种克服部分所述问题的动脉粥样硬化切除导管。该导管具有带磨削表面的旋转远侧尖端,使得所述导管能切割穿过CTO(慢性完全闭塞病变)。导管包括侧切割窗口和切割刀片,所述切割刀片被构造为延伸穿过切割窗口,从而在将导管经治疗部位朝近侧拉动时从治疗部位处的脉管壁上切下物质。导管包括被定位在切割窗口近侧的物质收集腔。在使用时旋转的磨削尖端使得导管能穿过治疗部位,即便是CTO。切割窗口行进到治疗部位的远侧,切割刀片伸出切割窗口,然后通过朝近侧穿过治疗部位拉动导管将物质从治疗部位切下。因为物质收集腔设置在切割窗口的近侧,所以缩短了切割窗口远侧的导管长度,从而使得导管能治疗具有短停放区的病灶。
虽然这种导管具有能克服部分上述问题的特征,但是仍然需要一种能用于进入并治疗脉管系统内的病灶的动脉粥样硬化切除导管,即使病灶位于难以现有导管治疗的位置的情况下以及即使脉管在治疗部位处被完全闭塞的情况下。另外,还需要一种被构造为将从切除位置切下的碎片有效传送到储存位置的动脉粥样硬化切除导管,即使储存位置被设置为与切除位置在近侧隔开的情况下。
发明内容
本文所描述的动脉粥样硬化切除导管具有克服现有装置所面临的问题的特征。在下面描述所述导管中所包含的区别特征。所述导管可以独立地或者组合地包括一个或多个所述特征,但所述导管被限制为所描述的特定实施例。在一个实施例中,动脉粥样硬化切除导管具有内驱动轴,所述内驱动轴旋转具有螺旋切割表面的远侧旋转组织钻头,使得所述导管能切割经过和穿过CTO。另外,该动脉粥样硬化切除导管具有由外驱动轴旋转的远侧切割元件,所述远侧切割元件被构造为当将所述导管朝远侧推过治疗部位时在治疗部位处从脉管壁上切下物质。内驱动轴和外驱动轴可以沿相同的(同向旋转)或者不同的(反向旋转)方向旋转。所述导管包括定位在切割元件和旋转组织钻头近侧的收集腔。所述导管可以包括引导从治疗部位切下的物质进入收集腔的装置。本发明的导管还可以可选地配置有粉碎可能阻塞或堵塞所述收集腔及相关通路的较大物质的装置,以及可配置有将从治疗部位收集到的物质传送到动脉粥样硬化切除导管中的近侧开口的装置。
在一个变型中,所述导管是一种用于从脉管的管腔切除物质的物质移除装置,包括:具有远侧端部和近侧端部以及管腔的管状鞘;延伸通过管状鞘的管腔的第一驱动轴,第一驱动轴被构造为沿第一方向旋转;延伸通过管状鞘的管腔的第二驱动轴,第二驱动轴被构造为沿第二方向旋转;联接到第一驱动轴的第一切割元件;联接到第二驱动轴的第二切割元件;以及驱动器,所述驱动器联接到第一驱动轴和第二驱动轴,并且被构造为沿第一方向旋转第一驱动轴和沿第二方向旋转第二驱动轴。驱动器可以包括联接到第一和第二驱动轴的单个驱动元件,或者可以可选地包括联接到第一驱动轴的第一驱动元件和联接到第二驱动轴的第二驱动元件。第一旋转方向可以与第二旋转方向相反或相同。第一驱动轴可以以第一转速旋转,而第二驱动轴可以以第二转速旋转。第一和第二转速可以相同或不同。第一驱动轴可以是管状的,并包括限定了管腔的内表面。第二驱动轴可以被至少部分地收容在第一驱动轴的管腔中。可选地,物质收纳腔被限定在第二驱动轴的外表面和第一驱动轴的内表面之间。可选地,第一驱动轴的内表面和第二驱动轴的外表面中的至少一个包括一个或多个凸起的物质传递元件(比如肋),一个或多个凸起的物质传递元件被构造为使从脉管的管腔切下的物质朝近侧方向移动。一个或多个凸起的物质传递元件可以被定位成螺旋图案。可选地,第一和第二切割元件具有第一状态和第二状态,在第一状态下第一和第二切割元件被收纳在管状鞘的管腔中,在第二状态下第一和第二切割元件至少部分地暴露在管状鞘的远侧端部以外。
在另一个变型中,一种可以包含上述部分或全部特征的导管被用于在脉管部位处从脉管管腔切除物质。方法包括:使管状鞘行进穿过脉管的管腔到达脉管部位近侧的位置;在管状鞘的管腔中沿第一方向旋转第一驱动轴;在管状鞘的管腔中沿第二方向旋转第二驱动轴;以及通过第一驱动轴和第二驱动轴的旋转,使管状鞘经脉管部位朝远侧行进通过脉管的管腔,从而利用第一切割元件和第二切割元件切除物质。第一和第二方向可以相同或可以不同。第一驱动轴可以以第一速度旋转,第二驱动轴可以以第二速度旋转,第一速度可以和第二速度相同或可以和第二速度不同。第一驱动轴可以是管状的并包括限定了管腔的内表面,第二驱动轴可以至少部分地被收纳在第一驱动轴的管腔中,其中第二驱动轴在第一驱动轴的管腔中旋转。第二驱动轴可以具有外表面,其中物质收纳腔被限定在第二驱动轴的外表面和第一驱动轴的内表面之间,其中该方法还包括将切下的物质朝近侧传送到物质收纳腔。第一驱动轴的内表面和第二驱动轴的外表面中的至少一个可以包括一个或多个凸起的物质传递元件,所述一个或多个凸起的物质传递元件被构造为使从脉管的管腔切下的物质朝近侧方向移动,其中使从切下的物质朝近侧传送到物质收纳腔包括旋转第一和第二驱动轴的至少一个。
通过下面的优选实施例、附图和权利要求的描述,本发明的以上和其他方面将变得清楚。将参考附图和下面的描述给出本发明的一个或多个实施例的细节。本发明的其他特征、目标和优点通过所述描述和附图以及权利要求将变得清楚。
附图说明
图1示出了一种动脉粥样硬化切除导管以及内外切割器驱动器的部分断面侧视图。
图2示出了本发明的动脉粥样硬化切除导管的远侧端部部分的断面立体图。
图3示出了本发明的动脉粥样硬化切除导管的远侧端部部分的断面侧视图。
图4示出了本发明的动脉粥样硬化切除导管的远侧切割元件的立体图。
图5-7示出了本发明的动脉粥样硬化切除导管的外切割器驱动轴的不同实施例的侧面剖视图。
图8示出了本发明的动脉粥样硬化切除导管的旋转组织钻头的立体图。
图9-11示出了本发明的动脉粥样硬化切除导管的内切割器驱动轴的侧视图。
图12示出了本发明的动脉粥样硬化切除导管的组织腔的断面侧向立体图。
图13和14分别示出了本发明的动脉粥样硬化切除导管的对准和未对准的切割器元件槽和钻头槽的远侧端部视图。
图15和16分别示出了本发明的动脉粥样硬化切除导管的一个替换实施例的断面立体图和端部视图。
图17和18分别示出了本发明的动脉粥样硬化切除导管的一个替换实施例的断面立体图和端部视图。
图19A,19B和19C示出了使用动脉粥样硬化切除导管的方法。
图20-22分别示出了本发明的动脉粥样硬化切除导管的一个替换实施例的断面立体图、侧视图和远侧端部视图。
图23-25分别示出了本发明的动脉粥样硬化切除导管的一个替换实施例的断面立体图、侧视图和端部视图。
具体实施方式
本文所描述的导管具有适用于腔内引导到目标体腔的导管体。所述导管体的尺寸和其他物理特征将会根据所要进入的体腔发生明显的变化。在用于脉管内引入的动脉粥样硬化切除导管的示例性情况中,导管体的远侧部分通常会极具柔性并且适合经导丝引导到脉管系统内的目标部位。具体地,导管在导丝通道完全延伸经过所述导管体时适合“经导丝”引入,或者在导丝通道仅延伸经过导管体的远侧部分时适合“快速交换”引入。在其他情况下,可以在导管的远侧部分上设置固定的或整体的线圈末端(coil tip)或导丝末端(guidewire tip),甚至省却整个导丝。为了便于图示,在所有实施例中没有示出导丝,但是应当明白导丝能够结合到本文所述的任意实施例中,就像它们被构造为与导丝一起使用那样。
用于脉管内引入的导管体通常会具有50cm-200cm范围内的长度,1French到12French(通常是3French到9French)范围内的外径(0.33mm:1French)。在冠状动脉导管中,该长度通常是125cm-200cm的范围,直径优选低于8French,更优选低于7French,最优选在2French-7French的范围内。导管体通常包括以常规挤压技术制得的有机聚合物。合适的聚合物包括聚氯乙烯、聚氨酯、聚酯、聚四氟乙烯(PTFE)、聚酰胺、硅橡胶、天然橡胶等等。可选地,导管体可以用编织物、螺旋线、线圈、轴向细丝等等进行加强,从而提高其旋转强度、断裂强度、粗糙度、推动能力、抗扭结性等等。合适的导管体可以通过挤压形成,需要时可以设有一个或多个通道。导管直径可以使用常规技术通过热膨胀和收缩来改变。因此所得到的导管适合通过常规技术引入脉管系统,包括冠状动脉和外周动脉。
图1-14示出了包括各种可选特征的动脉粥样硬化切除导管2。如图1所示(其是部分断面侧视图),导管2具有引入鞘5,引入鞘5是最外的鞘或层并且是暴露在脉管腔的导管层。引入鞘5可以由有机聚合物制造,并且作用是帮助导管2传送通过脉管的解剖结构。鞘5可以静止的或者被构造为经包封切割末端的远侧端部纵向地移动,从而实现导管的送入或取出。在使用时,鞘5可以回缩以暴露切割器。在旋转切割器工作时鞘5不会旋转,从而保护脉管系统免受旋转外切割器驱动轴3的旋转运动。如图2和3所示(其分别是导管2的远侧端部部分的断面立体图和侧视图),直接位于引入鞘下方并靠近引入鞘的是外切割器驱动轴3,外切割器驱动轴3被连接以旋转在导管远侧端部处的切割元件4,如下面进一步说明那样。外切割器驱动轴3可以由具有柔性和转矩能力的高模量材料或复合物(例如NiTi管、不锈钢线圈,或其他复合分层聚合物或金属材料)制成。外鞘5和外切割器驱动轴之间设有适当的间隙以允许外鞘和外切割器驱动轴之间形成带自由旋转运动的滑动配合。轴3与鞘5中的两者或之一可以用润滑涂层涂覆,以减少轴3与鞘5之间的摩擦。设置在外切割器驱动轴3的管腔21的中间的是内切割器驱动轴6。内切割器驱动轴6可以由具有柔性和转矩能力的高模量材料或复合物(例如NiTi管、不锈钢线圈,或其他复合分层聚合物或金属材料)制成。内切割器驱动轴6的作用是旋转第二切割元件,更具体地是旋转附接到驱动轴6的远侧端部的旋转组织钻头7。
远侧切割元件4在图4中示出了更多细节。远侧切割元件4通过焊接、钎焊、粘合等等被附接到外切割器驱动轴3。远侧切割元件4被用于从血液流动管腔(比如动脉或静脉血管)切除物质,并将从导管远侧末端收集到的组织物质朝近侧开口传送,将在下面更详细地描述。导管2包括通过焊接、钎焊、粘合等等附接到内切割器驱动轴6的旋转组织钻头7(两个切割元件中的第二个)。旋转组织钻头7可以被用于钻通管腔内的可能阻碍导管通过脉管朝远侧运动的任何阻塞物,并且可以帮助将从导管远侧末端收集到的组织物质经远侧开口或槽朝近侧开口9传送,将在下面更详细地描述。
导管2的外切割器驱动轴3在其近侧端部被联接到旋转外驱动轴3及所附接的远侧切割元件4的外切割器驱动器10。延伸穿过外切割器驱动轴3的管腔21的内切割器驱动轴6在其近侧端部被联接到旋转内驱动轴6及所附接的旋转组织钻头7的内切割器驱动器11。外切割器驱动器10和内切割器驱动器11分别供电并分别驱动内切割器驱动轴和外切割器驱动轴旋转,使得每个驱动轴能顺时针或逆时针旋转。在一个实施例中,导管2可以与都顺时针或逆时针旋转的内切割器驱动轴6和外切割器驱动轴3一起使用。在另一个实施例中,内切割器驱动轴和外切割器驱动轴中的一个可以顺时针旋转,内切割器驱动轴和外切割器驱动轴中的另一个可以逆时针旋转。内切割器驱动轴和外切割器驱动轴可以以相同的速度或以不同的速度旋转,如后面详细说明那样。虽然未示出,但本领域的技术人员应当明白,通过适当的传动,单个驱动电机能被用于旋转内切割器驱动轴和外切割器驱动轴。
导管2包括组织收集腔12。组织收集腔12包括在外切割器驱动轴的内表面和内切割器驱动轴的外表面之间的环形空间,组织收集腔12基本沿导管的整个长度在切割元件和手柄之间延伸,例如如图2和3所示。导管2可以设有附接至管的近侧开口9,从而通过在外切割器驱动轴3和内切割器驱动轴6之间的环形空间实现切割碎片的抽吸或流体(包括药物)的喷射。
外切割器驱动器10和内切割器驱动器11基本相似,并可以包括已知的任何合适的驱动电机和电源(例如,一个或多个电池)。切割器驱动器10和11被结合到能被附接在导管近侧端部处的手柄中。手柄包括用于控制电机的一个或多个杆或开关。在一个实施例中,两个切割器驱动器被一起接通,从而沿相反的方向旋转。或者,每个驱动器可以有控制开关,从而每个驱动器都可以独立于另一个地被供电。因此,可以独立于另一个切割器旋转一个切割器以及可能以不同的转速和转向。这在仅需要旋转内切割器、同时保持外切割器静止的情况下是有利的,例如用于通过组织收集腔12传送组织而不用外切割元件4进行切割。另外,在穿过CTO之后,有利的是回缩内切割器并继续利用外切割器切除粥样斑。所以,内切割器驱动轴相对于外切割器驱动轴可以是纵向可移动的。内切割器驱动轴的纵向行进或回缩由手柄上的控制杆控制。在另一个实施例中,有一个开关被用于给两个切割器驱动器同时供电。所述控制手柄能够设有给操作者控制每个切割器旋转方向的能力的控制器。
当外切割器驱动轴3旋转时,远侧切割元件4绕导管2的纵轴线LA旋转。远侧切割元件4可以以大约1到160000rpm的速度旋转,但也可以根据具体应用以任意合适的速度旋转。切割元件4可以由一个连续的零件形成,或者可以由通过焊接、钎焊、铜焊、粘合、机械互锁或其他手段随后接合在一起的多个零件构成。切割元件4可以由能保持切割边缘具有耐磨性的任意合适材料形成,例如硬化钢、碳化物或钛氮化物涂层钢。如图4所示,远侧切割元件4可以具有杯形表面24,杯形表面24引导被切割边缘22切下的组织通过开口或切割元件槽23,然后进入组织腔12。切割元件4包括被定位在远侧切割元件4的径向外周边缘上的远侧切割边缘22。在使用中,当切割元件4旋转时,切割边缘22在待移除的物质上形成大致圆形的切口。杯形表面24径向向内地引导切下的物质。
槽23与旋转组织钻头7的螺旋沟槽35的旋转组合地用于粉碎所述物质。所述槽具有大致平行于导管纵轴线(或者,所述槽被定向为与该纵轴线成一个角度)被定向的半圆柱形状,以及具有在0.001和0.030英寸之间、更典型地是在0.008和0.010英寸之间的直径,还具有在1和10mm之间、更典型地在4到6mm之间的长度。槽的尺寸被选择为给被切下的物质提供充分的空间以进入位于内外切割器驱动轴之间的环形收集腔。
在使用期间,使导管抵靠病灶的作用力促进被切下的物质经过这些开口进入导管。切割元件4包括大致圆柱形的内表面,所述内表面的直径在钻头架25处减小。位于大致垂直于导管纵轴线的平面内的朝近侧定向的环形表面将直径减小的钻头架25连接到内表面的直径较大部分。钻头架25的内圆周略大于旋转组织钻头7的圆周、但是小于外切割器驱动轴的圆周,并且作为允许旋转组织钻头7的旋转但限制朝远侧运动的支承表面。这防止旋转组织钻头7延伸越过导管2的远侧端部的距离超过理想距离。外切割器驱动轴可以在远侧切割元件的近侧位置26通过焊接、钎焊、铜焊或粘合被连接。
图5-7示出了外切割器驱动轴3的不同实施例的断面侧视图。在图5的实施例中,外切割器驱动轴3具有下推式剪刀28,剪刀28在外切割器驱动轴形成时先在外切割器驱动轴的表面上切出,然后朝着外切割器驱动轴的内直径被推入。通过激光或者通过在外切割器驱动轴上机械切割出剪刀外形的部分轮廓形成剪刀。在被切割以后,剪刀被向内推。下推式剪刀28是不连续的,并且根据应用可以形成以任意间距彼此间隔开的螺旋缠绕图案。在手柄和切割器之间的至少部分或全部的外切割器驱动轴3上设置剪刀28。另外,可以给驱动轴3的外表面添加薄板以产生一种水/气密封,例如,一种聚酯热收缩件。
在图6所示的另一个实施例中,外切割器驱动轴3a具有不连续的下推式螺旋肋29,螺旋肋29的形成与下推式剪刀28的形成基本类似。螺旋肋29的轮廓在外切割器驱动轴形成时先在外切割器驱动轴的外表面上切出,然后被朝着外驱动轴的内直径向下推。螺旋肋29形成为使得所述肋的每个不连续部分都与相邻部分隔开充分的距离,从而保证驱动轴的结构完整性。所述不连续部分设置在至少部分或全部的驱动轴上,并且形成螺旋缠绕图案。另外,可以给驱动轴3添加薄板以产生一种水/气密封,例如,一种聚酯热收缩管。
在图7所示的另一个实施例中,外切割器驱动轴3b具有在至少部分或全部的外驱动轴上连续的并形成螺旋缠绕图案的螺旋肋30。螺旋肋30形成在外切割器驱动轴3的内径上。螺旋肋30能通过将一个管附接到外切割器驱动轴3的内表面上形成,所述管具有附接在管内壁上的螺旋,或者所述管是一种具有内螺旋的模制管。应当注意到外切割器驱动轴的螺旋肋30可以像下推式剪刀28那样不连续地形成,或者根据应用可以具有沿组织腔的长度以预定间距隔开的分离的连续式螺旋缠绕图案。剪刀28及螺旋肋29和30可以朝近侧开口9引导组织,并且还粉碎可能已经形成的凝块或所收集的较大块的组织物质。外切割器驱动轴可以由具有充分柔性的任意合适的材料制成。应当注意到外切割器驱动轴根据应用可以形成为不具有剪刀或螺旋肋、或者组合剪刀和螺旋肋。另外,可以根据导管的具体应用选择剪刀和肋的螺旋图案的斜度。还应当注意到,外切割器驱动轴3(或本文所公开的任何其他实施例的外切割器驱动轴)能被额外地涂覆润滑剂、特氟龙或其他涂层,从而减少粥样斑块/组织粘到外切割器驱动轴上,或者具有抗凝剂或溶解血栓涂层(比如肝磷脂或尿激酶),以防止在组织收集腔12内发生血液凝固。
当内切割器驱动轴6旋转时,旋转组织钻头7围绕导管的纵轴线LA旋转。旋转组织钻头7以大约1-160000rpm的速度旋转,但是可以根据具体应用以任意其他合适的速度旋转。旋转组织钻头7可以由一个连续的零件形成,或者可以由通过焊接、钎焊、铜焊、粘合、机械互锁或其他手段随后接合在一起的多个零件构成。如图8所示,旋转组织钻头7具有远侧部分34,远侧部分34能形成为带有螺旋切割表面35,并且能钻过管腔内的阻塞物、然后引导被组织钻头切下的组织经开口或钻头槽31(以及切割器元件槽23)进入组织腔12。组织钻头7的尺寸适合于装配在远侧切割元件4内。更具体地,组织钻头7包括在远侧部分34基部处的轴衬32。轴衬32具有大于旋转组织钻头7的远侧部分34、但小于外切割器驱动轴3的钻头架25的圆周内表面的圆周外表面。轴衬32包括朝远侧定向的环形表面,该环形表面的尺寸被设置为抵靠钻头架25的朝近侧定向的环形表面,并且作为允许旋转、同时限制旋转组织钻头7的朝远侧运动的轴承。钻头槽31从近侧部分36延伸到远侧部分34。槽31和槽23设有使切割碎片能朝近侧移动进入收集腔的形状。例如,槽31可以具有沿近侧部分和远侧部分的表面的半圆柱形截面形状,以及延伸穿过轴衬32的圆柱形状。槽31的直径可以和槽23的相同。槽31具有两个作用。第一,槽31与槽23组合以剪切由外切割器切割边缘和组织钻头切下的物质,第二,槽31允许被切下的物质经导管的远侧端部进入导管2的组织收集腔。近侧部分36接收内切割器驱动轴6的远侧端部,如图2和3所示,并且可以通过焊接、钎焊、铜焊、或粘合被固定。
图9-12中示出了与导管2的其他部分分离的内切割器驱动轴6的多个实施例的视图。内切割器驱动轴6可以由具有足够柔性的任何合适材料制成,并且根据应用可以是基本实心或空心的。合适的材料包括具有柔性和转矩能力的高模量材料或复合物,例如NiTi管、不锈钢线圈或其他复合分层聚合物或金属材料。在内切割器驱动轴是空心的某些应用中,导丝管腔37可以沿内切割器驱动轴的长度延伸。内切割器驱动轴可以由螺旋缠绕的不锈钢线制成,所述不锈钢线是左旋缠绕或右旋缠绕的并且具有不延伸超出缠绕线外部尺寸的被焊接的近侧和远侧端部。内切割器驱动轴可以由编织钢线制成。在某些实施例中,内切割器驱动轴可以包括多层螺旋缠绕线。在某些情况下,相邻的螺旋缠绕线层以相反的旋向性被缠绕。
图9示出了内切割器驱动轴6的局部视图。在图9中内切割器驱动轴被定向为使得驱动轴的近侧和远侧端部(未示出)分别位于图9的左右两侧。内切割器驱动轴6已经被形成为具有根据需要在驱动轴的至少一部分或全部上连续的左旋螺旋绕圈38。所述螺旋可以像图9中所示那样被缠绕成左旋绕圈图案,或者像图10和11中所示那样具有右旋螺旋绕圈图案。不管在哪种情形下,所述螺旋沿一个方向旋转从而朝近侧拉动物质。当内切割器驱动轴6沿逆时针方向旋转时,螺旋绕圈38也旋转,并且在导管2的远侧端部处通过钻头槽31和切割器元件槽23收集的切除物质被朝着近侧开口9引导(图9中从右往左)。另外,当内外切割器驱动轴沿相反方向旋转时,内驱动轴6的螺旋绕圈38和外驱动轴的剪刀28或螺旋肋的反向旋转产生的物理压缩力将可能已经形成的血液凝块和收集的较大块组织粉碎。当然,如后面详细说明那样,内外切割器驱动轴可以以相同或不同的速度反向旋转,或者内外切割器驱动轴可以以相同或不同的速度同向旋转。
图10的内切割器驱动轴6a已经形成为具有螺旋通道18。螺旋通道18可以通过激光或机械切割工艺形成在实心或空心轴的表面上。所述工艺形成位于通道18之间以一种与图9中的驱动轴6类似的方式作用的螺旋肋。
图11的内切割器驱动轴6b组合了驱动轴6和6a的特征。驱动轴6b被形成为具有螺旋绕圈38的一部分和具有螺旋通道18的一部分。应当注意到内切割器驱动轴的螺旋绕圈可以像外切割器驱动轴的下推式剪刀28的形状和间距那样被制造为不连续的,或者可以根据应用具有沿组织腔的长度以预定距离隔开的分离的连续式螺旋绕圈图案。螺旋绕圈38和螺旋通道18可以朝近侧开口9引导组织,还可以粉碎已经形成的凝块或所收集的较大块组织物质。内切割器驱动轴可以由具有足够柔性的任何合适材料制成。应当注意到内切割器驱动轴可以根据应用被形成为不具有螺旋绕圈或螺旋通道,或者被制造为具有两者和其他的任意组合;剪刀和肋的螺旋图案可以是直线形的或任何合适图案。还应当注意到内切割器驱动轴6(或本文所公开的任何其他实施例中的内切割器驱动轴)可以被额外地涂覆有润滑剂(比如特氟龙)或其他涂层,以减少粥样斑块/组织粘到内切割器驱动轴上,或者涂覆抗凝血剂或溶解血栓涂层(比如肝磷脂或尿激酶),以防止在组织收集腔12内发生血凝。
在导管的示范使用期间,导管行进穿过脉管,直到导管2的远侧端部连同远侧切割元件4以及旋转组织钻头7被定位在脉管的治疗部位的近侧端附近或者就在其近侧。当远侧切割元件4和旋转组织钻头7被移动到脉管内的正确纵向位置时,外切割器驱动10被接合从而逆时针旋转外切割器驱动轴和远侧切割元件。内切割器驱动11也被接合从而以顺时针旋转内切割器驱动轴和旋转组织钻头。应当注意到内驱动轴的旋转可以是逆时针旋转,而外切割器驱动轴可以是顺时针旋转,或者根据螺旋肋的定向方向两个切割器驱动轴都顺时针或逆时针旋转。螺旋肋的旋转和定向的方向(左旋或右旋)将被选择为仅使得被切下的物质沿朝近侧方向从导管的远侧端部朝着近侧端部传送通过导管。如果内外切割器驱动轴都被设计为沿朝近侧方向推动物质的话,这是可能实现的。如果内外切割器驱动轴的一个被设计为朝近侧移动物质,而另一被设计为朝远侧移动物质或流体,只要朝近侧移动物质的那一个提供更大的推动力或者换句话说更大的传送率,这也是可能实现的。例如,内切割器驱动轴可以具有朝近侧移动物质的螺旋肋定向和旋转方向,同时外切割器驱动轴具有趋于朝远侧推动物质的肋或剪刀定向与旋转方向。只要内切割器驱动轴提供的推力大于外切割器驱动轴提供的推力(通过更快的转速或者具有更大物质容纳能力的更大绕圈节距来提供),物质通过导管的行进方向就会是朝近侧。或者,外切割器驱动轴可以具有朝近侧移动物质的肋或剪刀定向与旋转方向,而内切割器驱动轴具有趋于朝远侧推动物质或流体的螺旋肋定向。只要由外切割器驱动轴提供的推力大于由内切割器驱动轴提供的推力,物质通过导管的行进方向就会是朝近侧。在这些实施例中,相反的推力可以甚至用于进一步粉碎物质使其易于传送。还应当注意到根据应用所述切割器驱动轴中的一个可以被旋转而另一个静止。还应当注意到根据应用两个切割器驱动轴以及由此附接在切割器驱动轴上的远侧切割元件和旋转组织钻头能以相同的速度或不同的速度旋转。
在一个或两个切割器驱动器被供电之后,导管2经脉管被朝远侧推动,且远侧切割元件4和旋转组织钻头7处于旋转或切割位置,如下面更详细描述那样。应当注意到,在某些应用中,为了安全地钻过整个阻塞物,只有旋转组织钻头7被接合用于旋转。当导管2经血管朝远侧移动时,被远侧切割元件4和旋转组织钻头7切除的组织物质通过杯形表面24被引导进入切割器元件槽23和钻头槽31,然后到达被定位在远侧切割元件4和旋转组织钻头7近侧的组织收集腔12。如图12所示,组织收集腔12具有外切割器驱动轴,外切割器驱动轴具有依照连续螺旋右旋缠绕图案穿过该腔的螺旋肋30,并且内切割器驱动轴6具有依照连续螺旋左旋缠绕图案穿过该腔的螺旋绕圈38。当内切割器驱动轴6被接合时,螺旋绕圈38的旋转产生作用力,当内切割器驱动轴6沿逆时针方向旋转时,该作用力能够朝近侧开口9引导被收集在组织收集腔内的组织。额外地或替换地,当外切割器驱动轴3被接合时,螺旋肋30的旋转也能产生作用力,当外切割器驱动轴沿顺时针方向旋转,该作用力也能朝近侧开口引导在被收集在组织收集腔内的组织。螺旋肋和螺旋绕圈的左旋或右旋定向与内外切割器驱动轴的顺时针或逆时针旋转的组合能帮助引导物质流动通过组织腔,并且能根据应用变化。应当注意到本发明的螺旋绕圈、螺旋通道、螺旋肋和剪刀的斜度、尺寸、左旋或右旋缠绕图案以及间距都能根据应用和所需要的物质传送率变化。
图13和14示出了导管2的远侧端部视图。在图13中,远侧切割元件4的切割器元件槽23和旋转组织钻头7的钻头槽31被对准,并产生圆形槽道或通路,从脉管管腔切下的物质通过该通路以进入环形收集腔。图14示出了当远侧切割元件4和旋转组织钻头7逆向旋转时(或者以不同的速度同向旋转),所述槽的持续错开和再对准导致被收集的物质在经过钻头槽31和切割器元件槽23时被切碎。应当注意到,通过旋转组织钻头和远侧切割元件以不同的速度同向旋转也能引起钻头槽和切割器元件槽错开和再对准时组织的切碎。组织钻头和切割元件的逆向旋转所产生的这种切碎效果将较大组织物质粉碎,从而使得被收集的组织能更容易地经过槽进入组织收集腔。
所述组织被切下并经远侧切割元件和旋转组织钻头的槽被引导进入组织收集腔12。物质收集腔是细长的以容纳被切下并可与导管长度一样长的物质。导管体的近侧部分可以额外地具有近侧开口9,这样经导管传送的组织能通过该开口或侧壁端口离开。因为组织收集腔被定位在切割元件和组织钻头的近侧,组织收集腔的长度不受到治疗部位停放区大小的约束,所以组织收集腔能被制造成具有任意所需长度。当内切割器驱动轴6被接合时,螺旋绕圈38或螺旋通道18的旋转能产生作用力,根据螺旋绕圈或螺旋通道的旋转方向,该作用力能朝着近侧开口9朝近侧引导被收集在组织收集腔内的组织。额外地或替换地,当外切割器驱动轴被接合时,下推式剪刀28(或者螺旋肋29和30)的旋转能产生向心力,根据下推式剪刀(或螺旋肋29和30)的旋转方向,该向心力能朝着内驱动轴6a向内引导被收集在组织收集腔内的物质。内切割器驱动轴上的螺旋绕圈的旋转运动和旋转动量所产生的力导致被切下的物质和血液凝块被进一步粉碎和降解,原因在于所述物质和血液凝块受到了外切割器驱动轴3的下推式剪刀28的旋转运动和动量所产生的向心力的作用。螺旋绕圈和/或下推式剪刀的这些作用力还可以产生经旋转组织钻头7的钻头槽31和远侧切割元件4的切割器元件槽23的抽吸,从而帮助物质通过槽。应当注意到可以根据需要在某些应用中经近侧开口9施加额外的抽吸以帮助收集物质。
在另一个用途示例中,导管2将脉管壁上较柔软的粥样斑块切割成相对较大的条状物,并且远侧切割元件4的杯形表面24(在某些应用中连同旋转组织钻头7一起)引导这些条状物通过切割器元件槽23和钻头槽31然后进入收集腔12。因为收集腔12被定位在旋转组织钻头和远侧切割元件4的近侧,所以期望的是保持切割器元件槽23和钻头槽31尽可能地没有任何堵塞物(例如大到无法通过组织钻头和切割元件的槽的组织条状物)。当切割器元件槽23和钻头槽31对准和非对准时,旋转组织钻头7和远侧切割元件4的逆向旋转、或者在某些应用中是不同速度的同向旋转产生了剪切力,该剪切力有助于粉碎较大的组织条状物,并使得组织能更容易地通过槽传送进入组织收集腔。
还期望的是保持组织收集腔尽可能地没有堵塞物,以允许收集到的组织朝近侧开口9的近侧移动。在被收集在组织收集腔中的组织发生凝块或堵塞的情况下会发生另一种可能的阻塞,从而妨碍被切下的物质从收集腔朝近侧开口运动。如上所述,螺旋绕圈、螺旋肋、螺旋通道和下推式剪刀的旋转运动和旋转动量所产生的作用力使得任何阻塞或凝块在外切割器驱动轴3的下推式剪刀28的旋转运动和旋转动量所产生的剪切力的作用下被粉碎成更小的碎片。内切割器驱动轴和外切割器驱动轴的旋转根据应用可以是反向的或同向的旋转。期望的是保持收集在组织收集腔内的组织从导管远侧端部朝着近侧开口恒定地行进。如上所述,当内切割器驱动轴6被接合时,螺旋绕圈38的旋转产生了作用力,所述作用力根据螺旋绕圈的旋转方向将被收集在组织收集腔内的组织朝近侧开口9引导。额外地或替换地,当外切割器驱动轴被接合时,下推式剪刀28的旋转也产生了向心力,所述向心力根据下推式剪刀的旋转方向也能将被收集在组织收集腔内的组织朝近侧开口引导。在某些应用中,内切割器驱动轴和外切割器驱动轴能具有相同的朝近侧方向的转动。在其他应用中,内切割器驱动轴和外切割器驱动轴可以具有相反方向的转动。在驱动轴中的其中一个产生的作用力朝远侧传送物质或流体、而驱动轴中的另一个产生的作用力朝近侧传送物质的情况下,朝近侧传送物质的驱动轴的肋或下推式剪刀的转速、肋尺寸和/或节距可能必须大于朝远侧传送物质的驱动轴的肋或下推式剪刀的转速、肋尺寸和/或节距,以使得导致物质朝近侧传送的驱动轴产生的作用力将克服另一驱动轴产生的相反作用力。所以,驱动轴应当以产生朝近侧移动物质的净作用力的方式进行设计和运行。肋尺寸、剪刀和驱动轴之间的距离、节距、转轴之间的相对转速以及接触构件的表面光洁度或摩擦系数都能影响组织的传送能力,并且这些参数被设计为使得所需要的组织传送率最高。
图15-18是图1-14的导管的不同实施例的视图。导管2A被示出,其中导管2A的相同或相似的附图标记代表导管2的相同或相似的结构,所有关于导管2的相同或相似特征的描述都可以等同应用,除非另有说明。在图15和16所示的第一实施例中,导管2A的内切割器驱动轴6c是空心的,并具有沿内切割器驱动轴的整个长度延伸的导丝管腔37。旋转组织钻头7的导丝管腔39被定位成与内切割器驱动轴6c的导丝管腔37对准。内切割器驱动轴和旋转组织钻头的导丝管腔从导管2A的近侧端部延伸到远侧端部,所以导管可以被用作一种经导丝导管。图15示出了带有导丝GW的导管2A。
图17和18示出了包括快速交换导管的本发明的实施例。导管2B被示出,其中导管2B的相同或相似的附图标记代表导管2的相同或相似的结构,所有关于导管2的相同或相似特征的描述都可以等同应用,除非另有说明。导管2B包括侧部安装的管状部55,管状部55形成了用于接收导丝GW的相对短的导丝管腔。侧部安装的管状部55根据应用可以是1-30cm长。
在这里公开并在图19A-19C中示出使用图1-18的导管的示范方法。导丝被经皮地引入患者身体并行进到患者身体血管V内的关注区域。如果治疗部位是CTO,如图19A所示,那么导丝可能无法穿过该病灶。图19A示出了被完全闭塞的管腔,其中导丝(GW)已经行进到该阻塞物的近侧。导管2经导丝行进到阻塞物紧近侧的位置。在图19A中,导丝没有示出,原因在于导丝已经从导管中退出。远侧切割元件和旋转组织钻头在行进期间处于静止的位置,并且被鞘5所覆盖。现有的传统导管要么必须强制穿过该病灶,要么不得不放弃该治疗转而采用其他形式的治疗。通过给外切割器驱动器10和内切割器驱动器11的一个或两个供电从而使内外切割器驱动轴旋转,导管2(以及本文所描述的其他导管)能安全地穿过该阻塞物。内切割器驱动轴的旋转导致旋转组织钻头7旋转。旋转组织钻头7切开甚至已钙化的物质,从而使得导管能经过该病灶慢慢地行进,同时远侧切割元件4也与治疗部位相接合以从病灶上切下物质,如图19B和C所示。应当注意到,在某些应用中,只接合内切割器驱动轴以旋转该旋转组织钻头,从而初始钻过整个闭塞物;在其他应用中,可能需要一开始只接合外切割器驱动并在治疗部位处旋转远侧切割元件。被切下的物质被引导通过切割元件槽和钻头槽,然后进入收集腔。被施加给导管2并抵靠物质M的作用力产生了有助于迫使被切下的物质通过槽23,31的压力。通过使导管经治疗部位行进和回缩来重复所述切割过程,直到移除足够量的物质。在手术中的任何时刻,碎片可以通过导管被吸走,或者流体可以通过导管经内外驱动轴之间的环形空间被引入脉管。另外,在手术中的任何时刻,导丝可以被移走,并且碎片可以通过导丝管腔被吸走,或者流体通过导丝管腔引入脉管。图17和18中所示的导管2B被像上述那样使用,区别在于导管2B经侧部安装的管状部55所限定的导丝管腔内的导丝被行进到治疗部位。
图20-22示出了替换的导管实施例。导管2C被示出,其中导管2C的相同或相似的附图标记代表导管2的相同或相似的结构,所有关于导管2的相同或相似特征的描述都可以等同应用,除非另有说明。和导管2相比,内切割器驱动轴6d不具有分开的旋转组织钻头。内切割器驱动轴6a被形成为具有一个能钻过管腔中的阻塞物的钻头尖端8。内切割器驱动轴6d还额外地形成有螺旋通道18,螺旋通道18将被钻头尖端8和远侧切割元件44切下的物质经远侧切割元件44上的螺旋槽47传送进组织腔12。远侧切割元件44包括中间开口46,中间开口46的内圆周稍微大于内切割器驱动轴6d的外圆周。当内切割器驱动轴6d旋转时,螺旋通道18的凹陷使得物质从导管的远侧端部经驱动轴轴衬19被传送到收集腔12内。内切割器驱动轴具有附接的驱动轴轴衬19,所述驱动轴轴衬19能够被形成、被焊接、被铜焊等到内切割器驱动轴6d的表面上并且被容纳在具有稍微大于驱动轴轴衬19的外圆周的内圆周的切割元件部45内,所述驱动轴轴衬作为允许内驱动轴旋转、同时限制内切割器驱动轴6d朝远侧移动的轴承。切割元件槽47将切下的物质或组织向内朝着内切割器引导,从而使得组织经过导管远侧端部处的沟槽18,进入导管2的组织收集腔。在某些实施例中,远侧切割元件44可以具有杯形表面48,杯形表面48可以是没有破坏表面48光滑特性的通孔、齿、翅或其他特征的光滑连续的表面;在其他实施例中,杯形表面可以具有有限数量的齿、翅或其他特征。外切割器驱动轴3a可以在切割元件部45处通过焊接、钎焊、铜焊或粘合被连接到远侧切割元件44。这种连接使得切割元件44能随外切割器驱动轴3a旋转而旋转。
图23-25示出了替换的导管实施例。导管2D被示出,其中导管2D的相同或相似的附图标记代表导管2的相同或相似的结构,所有关于导管2的相同或相似特征的描述都可以等同应用,除非另有说明。导管2D和导管2C相似,区别在于轴衬19被定位在更近侧的位置,并且被容纳在外切割器驱动轴的内壁表面中的环形狭槽内。轴衬19以一种允许内切割器驱动轴旋转、但是又阻止内切割器驱动轴相对外切割器驱动轴朝近侧或远侧运动的方式被设置在该狭槽内。轴衬19被附接到内切割器驱动轴。远侧外壳体59和近侧外壳体60有效地将轴衬19收纳在其之间,从而沿朝近侧和朝远侧方向控制内驱动轴的纵向位置,并允许零件被组装。在该例中,被切下的组织必须从内驱动轴和轴衬19之间的组件的开放管腔下方以及开放管腔中经过。在该实施例中,外驱动轴被连接到具有齿56和翅57的切割元件54。
以上的说明和附图是为了描述本发明的实施例,无论怎样都不意味着限制本发明的范围。对于本领域技术人员来说在不脱离本发明精神和范围的前提下进行各种改动和变化是很明显的。所以,本发明意在覆盖落入后附权利要求及其等同物范围内的本发明的改动和变化。另外,虽然前面针对某些实施例描述了材料和构造的选择,但是本领域技术人员应当明白所描述的那些材料和构造对于所有实施例都是可用的。
Claims (20)
1.一种用于从脉管的管腔切除物质的物质移除装置,包括:
具有远侧端部和近侧端部以及管腔的管状鞘;
延伸通过管状鞘的管腔的第一驱动轴,第一驱动轴被构造为沿第一方向旋转;
延伸通过管状鞘的管腔的第二驱动轴,第二驱动轴被构造为沿第二方向旋转;
联接到第一驱动轴的第一切割元件;
在第二驱动轴的远侧端部处的第二切割元件;以及
驱动器,所述驱动器联接到第一驱动轴和第二驱动轴,并且被构造为沿第一方向旋转第一驱动轴和沿第二方向旋转第二驱动轴。
2.根据权利要求1所述的物质移除装置,其中驱动器包括联接到第一驱动轴的第一驱动元件和联接到第二驱动轴的第二驱动元件。
3.根据权利要求1所述的物质移除装置,其中第一方向和第二方向相反。
4.根据权利要求1所述的物质移除装置,其中驱动器被构造为以第一速度旋转第一驱动轴并且被构造为以第二速度旋转第二驱动轴,第一速度不同于第二速度。
5.根据权利要求1所述的物质移除装置,其中第一驱动轴是管状的并包括限定了管腔的内表面,并且其中,第二驱动轴被至少部分地包含在第一驱动轴的管腔中。
6.根据权利要求5所述的物质移除装置,其中第二驱动轴具有外表面,并且其中,物质收纳腔被限定在第二驱动轴的外表面和第一驱动轴的内表面之间。
7.根据权利要求6所述的物质移除装置,其中第一驱动轴的内表面和第二驱动轴的外表面中的至少一个包括一个或多个凸起的物质传递元件,所述一个或多个凸起的物质传递元件被构造为使从脉管的管腔切下的物质沿着近侧方向移动。
8.根据权利要求7所述的物质移除装置,其中所述一个或多个凸起的物质传递元件以螺旋图案被定位。
9.根据权利要求4所述的物质移除装置,其中第一方向和第二方向相同。
10.根据权利要求8所述的物质移除装置,其中所述一个或多个凸起的物质传递元件是螺旋肋。
11.根据权利要求1所述的物质移除装置,其中第一切割元件和第二切割元件具有第一状态和第二状态,在第一状态下第一切割元件和第二切割元件被收纳在管状鞘的管腔中,在第二状态下第一切割元件和第二切割元件至少部分地暴露在管状鞘的远侧端部之外。
12.根据权利要求1所述的物质移除装置,其中驱动器包括简单的驱动电机。
13.一种利用物质移除装置在脉管部位处从脉管的管腔切除物质的方法,所述物质移除装置包括具有远侧端部和近侧端部以及管腔的管状鞘、联接到第一切割元件的第一驱动轴和联接到第二切割元件的第二驱动轴,所述方法包括:
使管状鞘行进穿过脉管的管腔到达脉管部位近侧的位置;
在管状鞘的管腔中沿第一方向旋转第一驱动轴;
在管状鞘的管腔中沿第二方向旋转第二驱动轴;以及
通过第一驱动轴和第二驱动轴的旋转,使管状鞘经脉管部位朝远侧行进通过脉管的管腔,从而利用第一切割元件和第二切割元件切除物质。
14.根据权利要求13所述的方法,其中物质移除装置包括联接到第一驱动轴的第一驱动元件和联接到第二驱动轴的第二驱动元件,其中该方法还包括激活第一驱动元件以旋转第一驱动轴,以及激活第二驱动元件以旋转第二驱动轴。
15.根据权利要求13所述的方法,其中第一方向和第二方向相反。
16.根据权利要求13所述的方法,其中第一驱动轴以第一速度旋转,并且第二驱动轴以第二速度旋转,第一速度不同于第二速度。
17.根据权利要求13所述的方法,其中第一驱动轴是管状的并包括限定了管腔的内表面,并且其中,第二驱动轴被至少部分地包含在第一驱动轴的管腔中,并且其中,第二驱动轴在第一驱动轴的管腔中旋转。
18.根据权利要求17所述的方法,其中第二驱动轴具有外表面,并且其中,物质收纳腔被限定在第二驱动轴的外表面和第一驱动轴的内表面之间,并且其中,该方法还包括将切下的物质朝近侧传送到物质收纳腔。
19.根据权利要求18所述的方法,其中第一驱动轴的内表面和第二驱动轴的外表面中的至少一个包括一个或多个凸起的物质传递元件,所述一个或多个凸起的物质传递元件被构造为使从脉管的管腔切下的物质沿近侧方向移动,并且其中,将切下的物质朝近侧传送到物质收纳腔包括旋转第一驱动轴和第二驱动轴中的至少一个。
20.根据权利要求13所述的方法,其中第一方向和第二方向相同。
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JP2014501552A (ja) | 2014-01-23 |
US20150150590A1 (en) | 2015-06-04 |
BR112013009835A2 (pt) | 2016-07-26 |
EP2632352A1 (en) | 2013-09-04 |
KR20130055025A (ko) | 2013-05-27 |
JP2014193398A (ja) | 2014-10-09 |
US20170290604A1 (en) | 2017-10-12 |
KR101518147B1 (ko) | 2015-05-06 |
RU2539720C2 (ru) | 2015-01-27 |
RU2013117043A (ru) | 2014-12-10 |
CA2815186C (en) | 2015-12-29 |
AU2011319797A1 (en) | 2013-05-02 |
US20120109171A1 (en) | 2012-05-03 |
EP2632352B1 (en) | 2017-04-12 |
US20210346051A1 (en) | 2021-11-11 |
US10952762B2 (en) | 2021-03-23 |
AU2011319797B2 (en) | 2015-04-09 |
US8920450B2 (en) | 2014-12-30 |
WO2012058438A1 (en) | 2012-05-03 |
CN103200886B (zh) | 2015-07-29 |
US9717520B2 (en) | 2017-08-01 |
JP5636114B2 (ja) | 2014-12-03 |
CA2815186A1 (en) | 2012-05-03 |
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