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CN107106190A - 高速慢性全闭塞部横穿装置 - Google Patents

高速慢性全闭塞部横穿装置 Download PDF

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CN107106190A
CN107106190A CN201580047000.XA CN201580047000A CN107106190A CN 107106190 A CN107106190 A CN 107106190A CN 201580047000 A CN201580047000 A CN 201580047000A CN 107106190 A CN107106190 A CN 107106190A
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shaft
outer shaft
inner shaft
imaging device
occlusion
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CN107106190B (zh
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H·N·帕特尔
J·B·辛普森
R·拉德加比
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Vascular Phototherapy Company
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Avinger Inc
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Abstract

一种闭塞部横穿装置，包括外轴、内轴、光纤和附接到内轴和外轴的手柄。内轴在外轴内延伸。内轴包括位于其远端的钻削末端。光纤大致沿着内轴的中心轴线在内轴内延伸。光纤的远侧末端附接到钻削末端。手柄被构造成使内轴和钻削末端以大于500rpm的速度转动。

Description

高速慢性全闭塞部横穿装置
相关申请的交叉引用
此申请要求2014年7月8日提交的题为“HIGH SPEED CHRONIC TOTAL OCCLUSIONCROSSING DEVICES”的美国临时申请No.62/022,101的优先权，该申请的全部内容通过引用合并于此。此申请还要求2014年10月31日提交的题为“HIGH SPEED CHRONIC TOTALOCCLUSION CROSSING DEVICES”的美国临时申请No.62/073,850的优先权，该申请的全部内容通过引用合并于此。
通过引用合并
此文件中提到的所有公开文献和专利申请在本文中以相同程度合并，似乎是每篇单独公开文献或专利申请被具体和单独地指明通过引用合并。
背景技术
周边动脉疾病(PAD)和冠状动脉疾病(CAD)单独在美国就影响了成千上万的人们。PAD和CAD是可以在未治疗时造成灾难性后果的静默危险疾病。在美国，CAD是主要的死亡原因，而在50岁以上的患者中，PAD是主要的截肢原因，并且每年在美国造成大约160000次截肢。
冠状动脉疾病(CAD)和周边动脉疾病(PAD)都由于最为通常由动脉粥样硬化、斑块或脂肪物质沿着动脉壁的内衬聚集造成的血管逐渐缩窄而造成的。随着时间推移，这些物质硬化并变厚，这会与手臂、腿部、胃和肾的血液循环相干涉。这种缩窄形成闭塞部，完全或部分限制经过动脉的流动。到达脑部和心脏的血液循环会被减小，增加中风和心脏疾病的危险。
用于CAD和PAD的介入治疗可包括颈动脉内膜剥脱术和/或旋切术。颈动脉内膜剥脱术从堵塞动脉外科地移除斑块以恢复或改善血液流动。诸如旋切术的血管内疗法通常是微创技术，其打开或拓宽已经变窄或堵塞的动脉。其他治疗可包括血管成形术来打开动脉。例如，囊体血管成形术通常涉及将导管插入腿部或手臂动脉并定位导管，使得囊体位于堵塞部内。连接到导管的囊体被膨胀以打开动脉。医生会接着将丝网管(称为支架)放置在堵塞区域以保持动脉打开。
这种微创技术(例如旋切术、血管成形术等)通常涉及经过闭塞部放置导丝。使用导丝，一个或多个介入装置可被定位以使闭塞部移除或移位。遗憾的是，虽然对于有效治疗来说至关重要，导丝的放置会很困难。特别是，在横穿闭塞部放置导丝时，会难以在避免动脉损害的同时使导丝穿过闭塞部。例如，通常难以防止导丝被引导离开内腔进入外膜和周围组织，潜在地损害脉管并防止闭塞部的有效治疗。
因此，开发了旨在帮助导丝经过闭塞部的闭塞部横穿装置。但是，许多装置不能很好地装备成与成像一起使用，由此使导丝的放置麻烦和困难。此外，许多闭塞部横穿装置过大而不用于小直径周边动脉或冠状动脉中。
因此，这里描述了被设计成克服这些问题的一些问题的闭塞部横穿导管装置。
发明内容
这里描述了具有小轮廓和远侧钻削末端的闭塞部横穿装置。在一些实施方式中，关节运动特征结构可提供装置的转向或指引。在一些实施方式中，内轴可从外轴移除。
通常，在一种实施方式中，闭塞部横穿装置包括外轴、内轴、光纤和附接到内轴和外轴的手柄。内轴在外轴内延伸。内轴包括位于其远端的钻削末端。光纤大致沿着内轴的中心轴线在内轴内延伸。光纤的远侧末端附接到钻削末端。手柄被构造成使内轴和钻削末端以大于500rpm的速度转动。
这个和其他实施方式可包括一个或多个以下特征。内轴和光纤可以从外轴移除。手柄可包括被构造成使内轴相对于外轴锁定和解锁的卢尔锁。外轴可包括被构造成允许外轴弯曲的关节运动特征结构。关节运动特征结构可通过使内轴相对于外轴沿着中心轴线运动来启动。关节运动特征结构可包括主干和多个周向切口。内轴可包括被构造成与外轴的内唇部接合以使外轴在内轴向远侧推动时弯曲的环形构件。内轴可包括被构造成与外轴的内唇部接合以使外轴在内轴向近侧拉动时弯曲的环形构件。外轴可在其中包括预成型弯曲部。外轴还可包括相对于预成型弯曲部定位的标记，使得外轴的定向可以在成像期间确定。外轴可包括被构造成允许通过穿过其中的光纤进行成像的透明远侧部分。手柄可被构造成使内轴和钻削末端以大于1000rpm的速度转动。手柄可被构造成使内轴和钻削末端以大于500rpm的速度转动，使得图像可以大于或等于8帧每秒的速率由光纤生成。光纤可以是共路光学相干断层成像术光纤。钻削末端可包括多个螺旋切割刃。钻削末端可以是大致平滑的截锥末端。成像装置还可包括沿着外轴延伸的单轨导丝腔。外轴的外直径可以小于0.08英寸。
通常，在一种实施方式中，一种横穿闭塞部的方法包括：(1)将装置插入其中具有闭塞部的脉管；(2)使装置的内轴相对于装置的外轴转动，使得内轴上的钻削末端钻过闭塞部；以及(3)在转动内轴的同时，通过延伸穿过内轴的光纤以大于或等于8帧每秒的速率生成图像。
这个和其他实施方式可包括一个或多个以下特征。该方法还可包括从外轴移除内轴，并且使导丝插入穿过外轴。该方法还包括使装置的远端弯曲以使装置转向穿过脉管。使远端弯曲包括在内轴上推动或拉动。该方法还可包括使弯曲部在外轴内以期望方向定向。该方法还可包括使用装置上的标记以使弯曲部定向。使内轴转动包括以大于500rpm转动。
附图说明
本发明的新颖特征在随后的权利要求书中特别给出。本发明的特征和优点的更好理解将通过参考给出示例性实施方式的以下详细描述来获得，其中采用了本发明的原理，并且附图为：
图1A-3B示出具有关节运动特征结构的闭塞部横穿装置。
图4A-5C示出具有可分离的内轴和外轴的闭塞部横穿装置。
图6A和6B是用于这里描述的导管的驱动系统的示例性框图。
图7A-7B示出用于检测导管的驱动轴的位置的示例性方法。
图8A-8B示出具有关节运动特征结构和可分离的内轴和外轴的闭塞部横穿装置的关节运动。
图9A和9B示出定位在外轴内侧以便切割和成像的图8A-8B的闭塞部横穿装置的内轴。
图10示出移除了内轴的图8A-8B的闭塞部横穿装置的外轴。
图11A和11B示出与图8A-8B的闭塞部横穿装置一起使用的示例性手柄。
图12和13示出与图8A-8B的闭塞部横穿装置一起使用的另一示例性手柄。
图14A-14C示出闭塞部横穿装置的另一实施方式的远侧部分。
图15示出具有单轨导丝腔的图1A-3B的闭塞部横穿装置。
具体实施方式
这里描述的是一种闭塞部横穿装置，其具有小轮廓，从而能够在小直径动脉和冠状动脉中使用，例如经过5Fr(French：弗伦奇)导管或更小。通常，这里描述的装置可以具有机载成像，诸如光学相干断层成像术(OCT)成像。用于OCT成像的光纤可大致沿着装置的中心轴线延伸，由此减小装置的轮廓并允许高速转动。该装置还可包括可转动的带尖末端，允许向前钻削。在一些实施方式中，该装置可包括关节运动远端以使装置转向。
参考图1A-3B，在一种实施方式中，示例性导管100包括外轴122和连接到远侧末端103的内部驱动轴131。细长外轴122可以是中空的，并可具有大约1mm的内直径和大约1.5mm的外直径。在一些实施方式中，外轴122可具有线圈构造，由此线圈通过将线圈彼此叠置铺设来卷绕。例如，外轴122可包括至少两个线圈层。另外，线圈层可以反向卷绕，使得诸如内线圈层的一个线圈层具有左手铺设，并且诸如外线圈层的另一层具有右手铺设。线圈可在紧固外层的方向上提供转矩，在内层上向下夹持。第三反向卷绕线圈可被添加以便在两个方向上生成转矩。在另一实施方式中，轴122由编织钢丝加强聚合轴制成。在又一实施方式中，轴122可以是激光切割管。外轴122还可包括位于其远端的一个或多个成像窗口144。
套筒124(见图1D)可附接到轴122，诸如经过突片和狭槽机构148。套筒124可用作相对于内轴或末端103的承载表面。另外，套筒124可在任一侧上包括边缘或唇部151、152，其被构造成与内部驱动轴131或末端103相互作用，如下面进一步讨论。
末端103可被构造成例如使组织分离、切除或切碎。在一些实施方式中，末端103可包括到达装置中心处的点的尖锐螺旋凹槽113。另外，凹槽113可以倾斜，与另一方向相比，使其在一个方向上转动时具有更尖锐的边缘。因此，具有凹槽113的末端103可根据末端103的转动方向具有主动模式和被动模式。在被动模式中，具有凹槽113的末端103可不太具有侵入性，提供组织的钝化切除。在主动模式中，具有凹槽113的末端103可以更具有侵入性，提供切割和钻孔，以进入更硬的材料。在一些实施方式中，如下面相对于图14A和14B进一步描述，远侧末端103可具有平滑的倾斜表面，其没有凹槽。
内部驱动轴131(见图1D)可以连接到远侧末端103并可以沿着外轴122的中心延伸。内部驱动轴131可以被构造成在单个方向上或在顺时针方向和逆时针方向两者上转动，以使末端103相对于轴122在单个方向或在顺时针方向或逆时针方向上转动。环形环174、172可以围绕内部驱动轴131的远侧部分和/或末端103定位。环174、172可以贴靠套筒124的边缘151、152定位。环形套筒124可允许内部驱动轴131在防止轴向运动(并在一些实施方式中允许关节运动，如下面进一步描述)的同时相对于套筒124相对转动。
在一些实施方式中，外轴122的远侧部分可包括关节运动特征结构145。如图1A和1B所示，关节运动特征结构145可包括一个或多个主干245a、b和一系列周向切口247。一个或多个主干可只定位在导管的一侧上(例如横跨小于180度、小于150度或小于90度)。在一些实施方式中，并如图1A所示，一系列小周向切口295可在两个主干245a、b之间延伸，以便在弯曲期间提供附加柔性。周向切口247、295可被构造成围绕外轴122的不完整环或螺旋。参考图1B，在一些实施方式中，周向环247可在其中包括一个或多个中断部297a、b，其被设计成为关节运动特征结构145提供附加拉伸强度和压缩抗力。
关节运动特征结构145可附接到内部驱动轴131，使得驱动轴131的运动可启动关节运动特征结构。另外，在一些实施方式中，手柄200(见图2B和3B)可用来启动驱动轴131的运动。
参考图2A-2B，随着驱动轴131被向远侧推动，环形环172可在套筒124的近侧唇部152上向远侧推动(见图1D)，造成周向切口247在主干245a、b保持其长度(并且周向切口295更靠近地运动到一起)的同时扩张或打开。因此，关节运动特征结构145可朝着主干245a、b弯曲。如图2B所示，这种弯曲机构可在手柄20上启动，诸如通过向远侧运动环303和/或推动或运动按钮或杠杆。
同样，参考图3A-3B，随着驱动轴131向近侧拉动，环形环174可撞击套筒124的远侧唇部151。随着进一步的远侧力通过驱动轴131施加，周向切口247可开始更加靠近地运动到一起和/或切口247之间的材料可在主干245a、b保持其长度(并且切口295进一步运动远离)的同时重叠。因此，关节运动特征结构145可朝着周向切口247弯曲并远离主干245a、b。如图3B所示，这种弯曲机构可以在手柄200上启动，诸如通过向近侧运动环303和/或推动或运动按钮或杠杆。
关节运动特征结构145的弯曲运动可有利地允许装置100在使用在脉管内时转向，诸如用于在末端延伸离开闭塞部或内腔时重新进入。在一些实施方式中，导管100可被构造成通过在驱动轴131上推动或拉动而只在一个方向上弯曲，并且通过驱动轴131在相反方向上的运动来返回到图1A所示的直构型。
导管100还可包括附接到驱动轴131并被构造成与其一起转动的成像元件199。成像元件199可以是沿着驱动轴131的中心延伸的OCT纤维119的远端。成像元件199可随着导管100在脉管内使用来提供成像(经过窗口144)，由此帮助横穿闭塞部。
参考图15，在一些实施方式中，单轨导丝腔1505可以沿着外轴122延伸。导丝腔1505可例如在两个主干245a、b之间延伸，从而不为具有周向切口247的柔性区域添加附加刚性。
在一些实施方式中，导管100可与套管一起使用。套管可以是中空的，并能够包括附接在近端处的止血阀，其中冲洗口位于侧部，以有助于通过套管冲洗。套管还可有助于导丝放置到目标部位，特别是对于不包括单轨导丝腔的导管100的实施方式。即，导管100可用来横穿闭塞部，套管可放置其上，移除装置并且接着导丝可被引入。
参考图4A-5C，在另一实施方式中，示例性导管300包括内轴311、外轴322和连接到内轴311的远侧末端303。另外，外轴322可与内轴311分离。例如，内轴311可包括靠近近端的卢尔连接器，其能够与外轴322的近端上的卢尔连接器附接或脱离，如下面相对于手柄900描述。
在一些实施方式中，外轴322的远侧部分313可以是清澈或透明的，诸如由清澈或透明塑料制成，以允许经过其中成像。在一些实施方式中，外轴322还可在其中包括预成型弯曲部329，以帮助装置定向或转向。诸如金属标记的标记315可在远侧部分313内延伸，以便在使用时指示导管300的相对定向。例如，如图4B所示，弯曲部329的最内侧部分可与标记315对准。
另外，在一些实施方式中，内轴311可通过在连接到导管300的手柄(诸如手柄200)上滑动环而在中空的外轴322内纵向运动，以允许内轴311暴露(如图4A-4B所示)或被完全覆盖(如图5A-5C所示)。在使用中，内轴311可因此延伸出外轴，以帮助钻过闭塞部并在不需要切除时(或只在需要钝化切除时)拉入。在一些实施方式中，内轴311可被构造成相对于外轴322固定在多个点处，以改变暴露末端103的量。另外，内轴311可从外轴322完全移除，以允许导丝穿过其中放置。
另外，装置300可包括类似于以上相对于装置100描述的成像元件399。导管300可被构造成通过成像元件399在内轴311向远侧延伸离开外轴322时并在内轴311定位在外轴322(经过透明远侧部分313)内时成像。
装置300可进一步或替代地包括上面相对于装置100描述的任何特征、材料和/或尺寸。
参考图8A-10，在另一实施方式中，示例性导管800可包括可分离的内轴811和外轴822以及位于外轴822的远端上的关节运动特征结构845。
参考图8A-8B，关节运动特征结构845可包括主干945和一系列周向切口947。另外，如图9A所示，附接到外轴822的轴环860可包括被构造成相对于外轴822向内径向延伸的内凸缘862。同样，内轴811可包括环形构件872，诸如塑料轴承，其具有大于内轴811的其他部分的直径。因此，在内轴811被向远侧推动时，内轴811的环形构件872可推靠在轴环860的内凸缘862上。因此，外轴822可在切口947处朝着主干945弯曲(如图9A的箭头所示)。
如图10所示，内轴811可通过向近侧拉动内轴811从外轴822和轴环860完全移除。由此，外轴822可用作护套，例如用于导丝放置。
另外，内轴811可包括类似于上面相对于装置100和300描述的元件的成像元件877，其与内轴811一起转动。成像元件877可经过轴环860内的成像窗口866成像。另外，内凸缘862还可在内轴811位于外轴822内时用于使成像元件877与成像窗口866适当对准。
内轴811可包括类似于上面相对于装置100和300描述的可转动远侧末端803。同样，装置800可替代或另外包括上面相对于装置100和300描述的任何材料和尺寸。
参考图11A-11B，手柄900可用来操作装置800。手柄900可包括被构造成将内轴811和外轴822纵向锁定在一起的卢尔锁883。卢尔锁883可被构造成在外轴822和内轴811之间提供一些相对纵向运动，使得内轴811还可运动一小距离，诸如在大约0.125英寸-0.2英寸之间，以启动关节运动特征结构845。例如，内轴811可包括伸缩或弹性体分段以提供附加的相对运动。实际的位移距离分别取决于导管的外轴的直径、所期望的弯曲程度和外轴和内轴的伸长/压缩。外轴的直径越大，所期望的弯曲程度越大，并且轴的压缩/伸长越大，所需的位移量越大。另外，卢尔锁833可被构造成允许内轴811在外轴内自由转动，以提供连接到内轴811的尖锐远侧末端803的转动。卢尔锁833可被构造成使得外轴可相对于手柄的位置转动。在轴位于关节运动位置时，转动外轴在使用期间将使得导管围绕障碍物或朝着障碍物引导。如果卢尔锁883断开连接，如图11B所示，内轴811可通过手柄拉动离开外轴822，将外轴822留在原位，诸如用于导丝放置。
手柄900还可包括被构造成控制内轴811的轴向运动(以及装置800的关节运动)的杠杆885或环。在一些实施方式中，杠杆885可包括允许装置800以设定角度保持弯曲的锁定机构。手柄900还可包括附接到外轴822并被构造成转动外轴822(诸如360度)以便将装置800的弯曲部定位在期望定向的转动元件893。
另一示例性手柄1000在图12-13中示出。手柄1000可包括手柄900的许多特征。滑动按钮1085可用来控制内轴的轴向运动。转动元件1093可被构造成转动外轴822。
另外，在一些实施方式中，手柄内的外轴和内轴之间的连接可被构造成使得两个轴卡扣在一起，将近端轴向固定在一起，但允许它们独立转动。在其他实施方式中，第三元件可用来将两个轴键合、链接或栓接在一起。
虽然描述用于与导管800一起使用，手柄900、1000的特征结构可同样与导管100、300一起使用。
导管1400的另一实施方式的远端在图14A-14B中示出。导管1400类似于导管100、300、800，除了包括平滑的远侧末端103和模制的远侧部分1410。因此，远侧末端103可具有非扩张的并合并在一起成略微凸起的远侧尖1415的平滑倾斜表面1413(即末端可以是截锥的)。图14A、14B的远侧末端103可有利地提供穿过闭塞部的不太侵入的钻削。图14A和14B的远侧末端103可代替相对于导管100、300、800描述的任何远侧末端使用。同样，导管1400可包括模制的远侧部分1422。模制的远侧部分1412可类似于导管300的远端，并可包括套筒1424、透明部分1422和外轴的支架1452。另外，成像光纤1499可沿着装置的中心轴线延伸，如上面相对于其他实施方式描述。导管100、300、800的任何特征可以作为相对于导管1400描述的特征的附加或替代使用。同样，导管1400可与具有手柄200、900或1000的一些或所有特征的手柄一起使用。
在一些实施方式中，这里描述的导管的外轴的所有或一部分可以是清澈的，以允许经过其中成像。另外，在一些实施方式中，这里描述的导管可包括进行闭塞的囊体，以更好成像。囊体可以是清澈囊体以允许经过其中成像。
如上所述，导管100、300、800、1400可包括成像元件。成像元件可包括光纤，诸如光学相干断层成像术(OCT)成像光纤。光纤可在驱动轴或内轴内延伸，以便基本上沿着导管的中心轴线延伸，长达光纤的整个长度。光纤可附接在驱动轴或内轴的远端和/或远侧末端处，但是可以通过其他方式在驱动轴内自由浮动。成像光纤可传递用于其中放置装置的脉管的成像的OCT信号。在一些实施方式中，成像光纤可在驱动轴的长度上具有围绕它的聚酰亚胺涂层，以便在光纤在驱动轴内旋转时支承并保护光纤。另外，这里描述的手柄可以被构造成适应光纤内的一定量的松弛，以有助于驱动轴贴靠中空轴的延伸和缩回。
成像元件还可包括相对于光纤的中心轴线以一角度(诸如30-60度的角度，例如45度)定向的反光镜，使得来自于光纤的光将经过反光镜反射并进入相邻组织。可以使用胶来使得光纤的远端保持就位。胶可具有被构造成与光纤的折射率适当不匹配的折射率，如2010年5月28日提交的题为“OPTICAL COHERENCE TOMOGRAPHY FOR BIOLOGICAL IMAGING”且公开号为No.US-2010-0305452-A1的美国专利申请No.12/790,703以及2013年3月15日提交的题为“OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICALIMAGING”的国际专利申请No.PCT/US2013/031951所述，两个文件通过引用整体合并于此。另外，胶可沿着其外边缘具有弯月形状，如2013年3月15日提交的题为“OPTICAL COHERENCETOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING”的国际专利申请No.PCT/US2013/031951所述，其通过引用合并于此。弯月形状可有利地确保从胶的表面反射回来进入光纤的光显著小于所参照的光。
驱动轴或内轴以及成像元件或光纤可以被构造成以高速(诸如大于500rpm、大于600rpm、大于700rpm、大于800rpm、大于900rpm或大于1000rpm，例如在500-1000rpm之间)在一个或两个方向上连续转动，以提供围绕脉管内周的OCT成像。由使用者选择的在单个方向或不同方向上的这种高速转动(与替代地需要在两个方向上转动来管理光纤不同)允许更加快速地收集图像数据，由此在装置100的使用期间提供更准确和更新的图像。例如，图像可以大于6帧每秒(fps)(诸如大于或等于8fps或大于或等于10fps，诸如大约16.67fps)的速率生成。在示例性实施方式中，激光扫描的速率(诸如大于20KHz)可被构造成赶得上16.67帧每秒以及大于1200线每帧。
有利地，由于光纤延伸穿过这里描述的导管的中心，导管可以具有小直径。例如，这里描述的导管的外直径可以小于0.10”，诸如小于0.08”，诸如小于0.07”，小于0.06”，或小于0.05”。因此，这里描述的导管可有利地用于小直径的周边动脉和冠状动脉。
在一些实施方式中，这里描述的导管可被构造成附接到驱动系统。驱动系统可包括被构造成使光纤转动的转动光学结合部。可以与这里的装置结合使用的示例性驱动系统在2012年10月17日提交的题为“ATHERECTOMY CATHETERS AND NON-CONTACT ACTUATIONMECHANISM FOR CATHETERS”的美国专利申请No.13/654,357以及2013年3月15日提交的题为“ATHERECTOMY CATHETER DRIVE ASSEMBLIES”的国际专利申请No.PCT/US2013/032089中描述，每个申请通过引用整体合并于此。
在一些实施方式中，驱动系统可经由通信总线(在一些实施方式中可以是CAN总线2.0B)与控制系统通信。这种通信可以用来将状态输送到控制系统或控制台，诸如方向、速度、运转状态和其他信息。它也可用来将控制信息发送到驱动系统，诸如运转指令、速度、方向和参数设置，以便补偿导管的机械性能。参考图6A，在一种实施方式中，驱动处理器1601用作驱动系统的主要控制元件。驱动处理器1601经过马达控制器1602控制马达1603，其接收来自驱动处理器1601的指令/将状态返回到驱动处理器160。除了简单的速度和方向控制之外，驱动处理器1602还可执行算法以使导管性能最佳。驱动处理器1601经由CAN控制器1604与控制系统(例如装置的控制台)通信，以便发送和接收指令和状态。另外，在此实施方式中，位于驱动处理器1601壳体上的开关1605允许运转状态的当地控制。开关1605可通过替代的硬件输入(诸如按钮、拨动开关或旋钮)代替。
另外，在一些实施方式中，驱动系统可经由NFC或FRID与导管通信以获得有关导管的信息。作为例子，此信息可包括导管类型、最佳转动速度和方向、序列号以及许多可能参数。参考图6B，驱动系统经由NFC/RFID读取器1606和导管内的NFC/RFID标签1607与导管通信，以获得储存在标签内的信息。
驱动系统可被构造成允许驱动轴和切割器根据使用者优选在顺时针或逆时针方向上连续转动。因此，在一些实施方式中，驱动系统可包括使用者寻址开关，诸如拨动开关，以设置所期望的方向。
另外，在一些实施方式中，驱动系统可包括确定驱动轴在顺时针或逆时针方向上转动量的机构。参考图6A和6B，在一种实施方式中，例如，驱动系统可提供有关马达方向的信息。速度和方向可通过控制线(可以是专用线或多路信号)中的数据线通过控制系统(或控制台)检测。专用线可载有模拟或数字信号。在一种实施方式中，专用电压线载有六个离散速度(矢量速度+方向)，其通过控制系统或控制台解释，以推断导管的速度和方向。
参考图7A-7B，在一种实施方式中，驱动系统中的标示可包括围绕马达的标示的不对称设计或不对称定位(见图7A)。控制器可接着通过检测一序列独特标示的间距和/或宽度来检测马达方向，如图7B所示。
另外，在一种实施方式中，驱动系统可被构造成以多个离散速率转动驱动轴，和/或包括旋钮来允许使用者连续选择的可变速度。
这里描述的任何导管可以是形状设定的，或包括形状设定特征，以增强可追踪性和导航性。
如这里使用，成像元件可包括OCT光纤，诸如光纤的远端，以及反射镜和用来将反射镜和光纤保持就位的粘结剂。
如以上描述，这里描述的导管可包括光学相干断层成像术成像，诸如共路OCT。这种OCT系统在2010年7月1日提交的题为“CATHETER-BASED OFF-AXIS OPTICAL COHERENCETOMOGRAPHY IMAGING SYSTEM”且公开号为No.US-2010-0021926-A1的美国专利申请No.12/829,267、2010年5月28日提交的题为“OPTICAL COHERENCE TOMOGRAPHY FOR BIOLOGICALIMAGING”且公开号为No.US-2010-0305452-A1的美国专利申请No.12/790,703、以及2013年3月15日提交的题为“OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FORBIOLOGICAL IMAGING”的国际专利申请PCT/US2013/031951中描述，所有这些申请通过引用整体合并于此。替代地，其他类型的成像可以与这里描述的导管一起使用。例如，这里描述的装置可被构造成与红外光谱或超声一起工作。
这里描述的导管100、300、800、1400可用于血管内的闭塞部横穿。有利地，该装置可在这种横穿期间经过弯曲/转向和高成像速度有利地提供增加的可追踪性。
有关本发明的附加细节(包括材料和制造技术)可在相关领域中的技术人员水平内采用。对于通常或逻辑上采用的附加举措来说，也同样适用于本发明的基于方法的方面。同样，设想到所描述的创新性变型的任何任选特征可以单独地或与这里描述的任何一个或多个特征组合地提出或要求保护。同样，对于单数形式来说，包括给出的多个相同项目的可能性。更具体地，如这里使用并在所附权利要求中，单数形式“一个”、“和”、“所述”和“该”包括复数个所指对象，除非文中另外清楚指明。进一步注意到权利要求可以被撰写为排除任何的任选元件。因此，此陈述旨在用作与权利要求元件的叙述相结合地使用如“唯一”、“只有”等这种排它术语或“负面”限定使用的前提基础。除非这里另外限定，这里使用的所有技术和科学术语具有与本发明所属的本领域普通技术人员通常理解相同的含义。本发明的范围不通过本说明书限制，而是只通过所采用的权利要求术语的直白含义限制。
在特征结构或元件这里被描述为位于另一特征结构或元件“上”时，它可以直接位于另一特征结构或元件上，或者也可存在中介特征结构和/或元件。相比之下，在特征结构或元件被描述为“直接”位于另一特征结构或元件“上”时，不存在中介特征结构或元件。也将理解到在特征结构或元件被描述为“连接”、“附接”或“联接”到另一特征结构或元件时，它可以直接连接、附接或联接到另一特征结构或元件，或者可以存在中介特征结构或元件。相比之下，在特征结构或元件被描述为“直接连接”、“直接附接”或“直接联接”到另一特征结构或元件时，不存在中介特征结构或元件。虽然相对于一种实施方式描述或表示，如此描述或表示的特征结构和元件可适用于其他实施方式。本领域普通技术人员也将理解到结构或特征结构被描述为“相邻”另一特征结构布置可具有与相邻特征结构重叠或位于其下侧的部分。
这里使用的术语只出于描述特定实施方式的目的，而不打算限制本发明。例如，如这里使用，单数形式“一”、“一个”和“该”也旨在包括复数形式，除非文中另外清楚指明。还将理解到此说明书中使用的术语“包括”和/或“包含”表明所述特征结构、步骤、操作、元件和/或部件的存在，但是不排除一个或多个其他特征结构、步骤、操作、元件、部件和/或其组的存在或添加。如这里使用，术语“和/或”包括相关列举项目中的一个或多个的任何和所有组合，并可以缩写为“/”。
诸如“下方”、“下面”、“之下”、“上方”、“上面”等空间相对术语可在这里用于简便描述以描述一个元件或特征结构与附图所示的另一元件或特征结构的关系。将理解到空间相对术语旨在包括该装置在使用或操作中的不同定向，除了附图所示的定向之外。例如，如果附图中的装置是倒置的，描述位于另一元件或特征结构“下方”或“之下”的元件也可以定向在另一元件或特征结构的“上方”。因此，示例性术语“下方”可包括上方和下方两种定向。该装置可通过其他方式定向(转动90度或位于其他定向上)，并且这里使用的空间相对描述也相应地得到解释。类似地，术语“向上”、“向下”、“竖直”、“水平”等在这里只用于说明目的，除非另外具体指明。
虽然术语“第一”和“第二”可以在这里用来描述不同的特征结构/元件，这些特征结构/元件不应该被这些术语限制，除非文中另外指明。这些术语可用来将一个特征结构/元件与另一特征结构/元件区分。因此，下面描述的第一特征结构/元件可以称为第二特征结构/元件，并且类似地，下面描述的第二特征结构/元件可以称为第一特征结构/元件，而不偏离本发明的教导。
如这里在说明书和权利要求中使用，包括例子中所使用的，并且除非另外具体表明，所有数字可被读作加上前缀“大约”或“大致”，即使这些术语没有明确出现。表述“大约”或“大致”可以在描述大小和/或位置时使用以指示所描述的数值和/或位置在数值和/或位置的可以理解的希望范围内。例如，数值可以具有所述数值的+/-0.1％(或值的范围)、所述数值的+/-1％(或值的范围)、所述数值的+/-2％(或值的范围)、所述数值的+/-5％(或值的范围)、所述数值的+/-10％(或值的范围)等的数值。这里引用的任何数值范围旨在包括其中包含的所有子范围。

Claims (24)

1.一种闭塞部横穿装置，包括：
外轴；
内轴，内轴在外轴内延伸，内轴包括位于其远端的钻削末端；
光纤，光纤大致沿着内轴的中心轴线在内轴内延伸，光纤的远侧末端附接到钻削末端；以及
手柄，手柄附接到内轴和外轴，并被构造成使内轴和钻削末端以大于500rpm的速度转动。
2.根据权利要求1所述的闭塞部横穿装置，其中，内轴和光纤能够从外轴移除。
3.根据权利要求2所述的闭塞部横穿装置，其中，手柄包括被构造成相对于外轴锁定和解锁内轴的卢尔锁。
4.根据权利要求1所述的成像装置，其中，外轴包括被构造成允许外轴弯曲的关节运动特征结构，关节运动特征结构通过内轴相对于外轴沿着中心轴线运动来启动。
5.根据权利要求4所述的成像装置，其中，关节运动特征结构包括主干和多个周向切口。
6.根据权利要求4所述的成像装置，其中，内轴包括环形构件，环形构件被构造成与外轴的内唇部接合以便在内轴被向远侧推动时使外轴弯曲。
7.根据权利要求4所述的成像装置，其中，内轴包括环形构件，环形构件被构造成与外轴的内唇部接合以便在内轴被向近侧拉动时使外轴弯曲。
8.根据权利要求1所述的成像装置，其中，外轴在其中包括预成型弯曲部。
9.根据权利要求1所述的成像装置，其中，外轴还包括标记，标记相对于预成型弯曲部定位，使得外轴的定向能够在成像期间确定。
10.根据权利要求1所述的成像装置，其中，外轴包括透明远侧部分，透明远侧部分被构造成允许通过穿过其中的光纤成像。
11.根据权利要求1所述的成像装置，其中，手柄被构造成使内轴和钻削末端以大于1000rpm的速度转动。
12.根据权利要求1所述的成像装置，其中，手柄被构造成使内轴和钻削末端以大于500rpm的速度转动，使得图像能够由光纤以大于或等于8帧每秒的速率生成。
13.根据权利要求1所述的成像装置，其中，光纤是共路光学相干断层成像术光纤。
14.根据权利要求1所述的成像装置，其中，钻削末端包括多个螺旋切割刃。
15.根据权利要求1所述的成像装置，其中，钻削末端是大致平滑截锥末端。
16.根据权利要求1所述的成像装置，还包括沿着外轴延伸的单轨导丝腔。
17.根据权利要求1所述的成像装置，其中，外轴的外直径小于0.08英寸。
18.一种横穿闭塞部的方法，包括：
将装置插入其中具有闭塞部的脉管；
使装置的内轴相对于装置的外轴转动，使得内轴上的钻削末端钻过闭塞部；以及
在转动内轴的同时，通过延伸穿过内轴的光纤以大于或等于8帧每秒的速率生成图像。
19.根据权利要求18所述的方法，还包括：
从外轴移除内轴；以及
将导丝插入穿过外轴。
20.根据权利要求18所述的方法，还包括使装置的远端弯曲以使装置转向穿过脉管。
21.根据权利要求20所述的方法，其中，使远端弯曲包括在内轴上推动或拉动。
22.根据权利要求18所述的方法，还包括使弯曲部在外轴内以期望方向定向。
23.根据权利要求22所述的方法，还包括使用装置上的标记以使弯曲部定向。
24.根据权利要求18所述的方法，其中，使内轴转动包括以大于500rpm转动。
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CA2955242A1 (en) 2016-01-14
US11147583B2 (en) 2021-10-19
US20180146978A1 (en) 2018-05-31
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US10357277B2 (en) 2019-07-23
US20240180584A1 (en) 2024-06-06
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EP3166512A1 (en) 2017-05-17
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US20220039828A1 (en) 2022-02-10
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WO2016007652A1 (en) 2016-01-14
CN107106190B (zh) 2020-02-28

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