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CN109414273A - 具有可塑形的远侧头端的斑块切除导管 - Google Patents

具有可塑形的远侧头端的斑块切除导管 Download PDF

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CN109414273A
CN109414273A CN201780041300.6A CN201780041300A CN109414273A CN 109414273 A CN109414273 A CN 109414273A CN 201780041300 A CN201780041300 A CN 201780041300A CN 109414273 A CN109414273 A CN 109414273A
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distal
ridge
catheter
atherectomy catheter
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CN109414273B (zh
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H·N·帕特尔
A·J·费尔南德兹
V·耶
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D1/00—Surgical instruments for veterinary use
    • A61D1/02—Trocars or cannulas for teats; Vaccination appliances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00305—Constructional details of the flexible means
    • A61B2017/00309—Cut-outs or slits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00331—Steering mechanisms with preformed bends
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00738—Aspects not otherwise provided for part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • A61B2017/320791—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter with cutter extending outside the cutting window
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils

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Abstract

一种用于血管中的斑块切除导管包括细长导管主体和环形刀具。所述细长导管主体包括具有预设曲率的固定拐弯区段和具有比所述细长导管主体的其余部分大的灵活性的柔性区段。所述固定拐弯区段和柔性区段由其中包括多个周向狭缝的框架形成。本文还描述了一种用于血管中的斑块切除导管，其包括细长导管主体、环形刀具和在细长导管主体中的s形弯曲部分。所述弯曲部分包括具有纵向近侧脊部和纵向远侧脊部的框架。所述纵向近侧脊部与所述纵向远侧脊部呈大约180度而定位。

Description

具有可塑形的远侧头端的斑块切除导管
相关申请的交叉引用
本申请要求于2016年6月30日提交的题为“ATHERECTOMY CATHETER WITHSHAPEABLE DISTAL TIP”的美国临时专利申请No.62/357,173的优先权，其通过引用全文并入本文。
本申请还会涉及2013年3月15日提交的题为“ATHERECTOMY CATHETER WITHIMAGING”的美国公开No.20150141816，其通过引用全文并入本文。
通过引用并入
本说明书中提及的所有公开和专利申请以就好像每个单独公开或专利申请通过特定和单独地引用而并入的方式通过引用全文并入本文。
技术领域
本发明描述了用于医治受阻塞的体腔的装置，比如用于从血管去除阻塞材料。具体地，本发明描述了适于容易地对积聚在血管内的组织和斑块进行操纵以用于减积的斑块切除导管。
背景技术
动脉粥样硬化是在人的动脉中积聚了粥样材料的累积物的疾病。动脉粥样硬化作为自然衰老过程的一部分而发生，但还可能由于人的日常饮食、高血压、血管受损、遗传等而发生。动脉粥样硬化可影响到人体中的任何动脉，包括心脏、大脑、手臂、腿部、骨盆和肾脏中的动脉。动脉粥样硬化沉积物同样在其性质上会是多样的。一些沉积物相对较软，其他类型的可能是纤维性的，一些是钙化的，或者为所有三种的组合。基于斑块累积物的位置，可发展出不同的疾病。例如，当斑块积聚在对心脏供应含氧血的冠状动脉中时，发生冠心病。如果斑块积聚物堵塞了颈动脉(位于颈部每一侧的对大脑供氧的动脉)，则结果可能是中风。
可以以包括药物、心脏搭桥手术和基于导管的方法的各种方式来医治动脉粥样硬化。斑块切除手术过程涉及切除或取出堵塞血管的材料。许多斑块切除导管通常具有基本上笔直的中心轴线。然而，具有笔直外形的斑块切除导管会难以操纵得与动脉壁的内表面足够接近以去除所有斑块积聚物。此外，当斑块形成物累积在动脉的弯道和更曲折部分中时，这种笔直外形的导管使得斑块去除复杂化。
本发明所描述的斑块切除导管解决了这些挑战中的一部分。
发明内容
一般而言，在一个实施例中，一种用于血管中的斑块切除导管包括细长导管主体和环状刀具。所述细长导管主体包括具有预设曲率的固定拐弯区段和具有比所述细长导管主体的其余部分大的灵活性的柔性区段。所述固定拐弯区段和柔性区段由其中包括多个周向狭缝的框架形成。
所述和其他实施例可包括以下特征中的一个或多个。在所述固定拐弯区段中的框架还可包括从其延伸通过的不具有狭缝的纵向脊部。所述斑块切除导管还可包括所述环形刀具延伸通过的切割窗口。所述切割窗口可以位于所述固定拐弯区段和所述柔性区段的远侧，以将所述刀具抵入血管中。所述斑块切除导管还可包括位于所述固定拐弯区段的框架上方或下方的至少一个层压层。所述层压层可由聚合物制成。所述框架可由金属制成。所述多个周向狭缝可布置成重复构型。所述固定拐弯区段可在所述细长导管主体中形成130°至160°的角度。所述框架还可包括不具有狭缝的在所述固定拐弯区段与所述柔性区段之间延伸的环形脊部。所述柔性区段可被配置为被动地弯折至130°至160°的角度。
一般而言，在一个实施例中，一种用于血管中的斑块切除导管包括细长导管主体、环形刀具以及在所述细长导管主体中的s形弯曲部分。所述弯曲部分包括框架，所述框架具有通过纵向近侧脊部和纵向远侧脊部连接在一起的多个环形脊部。所述纵向近侧脊部与所述纵向远侧脊部呈大约180度定位。
所述和其他实施例可包括以下特征中的一个或多个。所述多个环形脊部可包括第一环形脊部、第二环形脊部和第三环形脊部。所述纵向近侧脊部可连接所述第一环形脊部和所述第二环形脊部，并且所述纵向远侧脊部可连接所述第二环形脊部和所述第三环形脊部。所述斑块切除导管还可包括所述环形刀具延伸通过的切割窗口。所述切割窗口可定位于所述弯曲部分的远侧以及所述s形弯曲的外圆周上，以将所述刀具抵入所述血管中。所述s形弯曲部分可被配置为通过拉拽或推动所述斑块切除导管的轴而被激活。所述斑块切除导管还可包括定位在所述框架上方或下方的至少一个层压层。所述层压层可由聚合物制成。所述框架可由金属制成。所述纵向远侧脊部可相邻于所述刀具的暴露部分而定位。所述纵向远侧脊部与所述刀具的所述暴露部分可在所述细长导管主体的同一侧上。所述纵向近侧脊部可形成第一角度，并且所述纵向远侧脊部可形成第二角度。所述第一角度和所述第二角度可在相反方向上延伸，并且所述第一角度可在140与160度之间，所述第二角度可在140与160度之间。所述多个脊部中的最远侧脊部可包括具有斜角的远侧边缘。所述斑块切除导管还可包括头锥，其被配置为从所述细长主体拧转脱离以暴露所述刀具。所述斜角(bevel)可被配置为提供用于所述头锥拧转的空间。
一般而言，在一个实施例中，一种用于血管中的斑块切除导管包括细长导管主体、环形刀具以及在所述细长导管主体中的s形弯曲部分。所述弯曲部分包括具有近侧区段和远侧区段的框架。所述近侧区段具有多个周向近侧狭缝和不具有狭缝的纵向近侧脊部，所述远侧区段具有多个周向远侧狭缝和不具有狭缝的纵向远侧脊部。所述纵向近侧脊部与所述纵向远侧脊部呈大约180度定位。
所述和其他实施例可包括以下特征中的一个或多个。所述斑块切除导管还可包括所述环形刀具延伸通过的切割窗口。所述切割窗口可定位于所述远侧区段的远侧以及所述s形弯曲的外圆周上，以将所述刀具抵入所述血管中。所述s形弯曲部分可被配置为通过拉拽或推动所述斑块切除导管的轴而被激活。所述斑块切除导管还可包括定位在所述框架上方或下方的至少一个层压层。所述层压层可由聚合物制成。所述框架可由金属制成。所述多个周向近侧狭缝可布置为第一重复构型，并且所述多个周向远侧狭缝可布置为第二重复构型。所述第一重复构型和所述第二重复构型可在周向上彼此偏置。所述纵向远侧脊部可相邻于所述刀具的暴露部分而定位。所述纵向远侧脊部与所述刀具的所述暴露部分可在所述细长导管主体的同一侧上。所述近侧区段可形成第一角度，并且所述远侧区段可形成第二角度。所述第一角度和所述第二角度可在相反方向上延伸，并且所述第一角度可在140与160度之间，所述第二角度可在140度与160度之间。所述框架还可包括在所述近侧区段与所述远侧区段之间延伸的不具有狭缝的环形脊部。
附图说明
在后面的权利要求中具体阐述了本发明的新颖特征。通过参考对利用了本发明原理的例示性实施例以及附图进行阐述的以下详细描述，将会更好地理解本发明的特征和优点，附图中：
图1A示出具有固定拐弯(jog)的斑块切除导管。
图1B示出在血管中的图1A的斑块切除导管。
图2示出具有相对角度和尺寸的图1A的斑块切除导管的绘图。
图3A示出斑块切除导管的远端的变型，其包括具有加强构件的用户激活的弯曲部分，加强构件在被激活时使得导管变形为预定弯曲构造。
图3B是示出图3A的斑块切除导管的加强构件的示意图。
图4A和图4B示出具有远侧弯曲部分的斑块切除导管的另一实施例。
图5A是斑块切除导管的用户激活的弯曲部分的俯视图。
图5B和图5C是图5A的弯曲部分的透视图。
图5D是图5A的弯曲部分的展开图。
图6A示出包括用户激活的弯曲部分的另一实施例的斑块切除导管。
图6B示出包括环形和纵向脊部的图6A的弯曲部分的框架。
图6C示出图6B的脊部的侧视图。
图6D示出图6B的脊部的横截面图。
图6E是图6B的脊部的展开图。
图7A示出包括固定拐弯区段和柔性区段的斑块切除导管的一部分。
图7B示出图7A的导管的弯曲部分的展开图。
图8A示出用于斑块切除导管的示例柔性头锥。
图8B示出图8A的头锥的一部分的展开图。
具体实施方式
本发明描述了具有细长主体的斑块切除导管，细长主体带有弯曲远侧部分、头锥和可旋转环形刀具。弯曲部分(其还可被称为弯折/可弯部分或拐弯机构)可有利地用来将刀具推向血管壁以提高切割效率。
图1A和图1B示出具有沿着细长导管主体的弯曲部分的示例斑块切除导管100。参照图1A至图2，斑块切除导管100可包括具有弯曲部分133的导管主体101、在导管主体101的远端处的可旋转环形刀具103、和在导管主体101的远端处的头锥105。头锥105可以包括配置为允许刀具103通过其进行切割的切割窗口107。导管101还可以包括在导管主体101中的弯曲部分133以沿径向将刀具103推抵血管壁。
弯曲部分133可以是固定拐弯(即，具有预设形状)。此外，可以将弯曲部分弯曲或弯折为使得切割窗口107在弯曲部分133的径向最外部分上(从而允许切割窗口107在使用时抵住血管壁)。在一种实施例中，例如可以通过使用嵌入外轴中的预偏转成形设置的镍钛合金带状片段来预先形成弯曲部分133。弯曲部分133可以具有曲率相反(即，一个向上弯曲而另一个向下弯曲)的两个转折点155、166，以形成近似“s”形。在一个实施例中，s形可以被配置为使得导管主体101的远端偏置于但基本上平行于导管主体101的近端。在其他实施例中，导管主体101的远端和近端可以彼此略微倾斜以控制刀具与血管壁接合的角度。
因此，如图2所示，弯曲部分133的“s形”可以包括具有长度b的近侧区段137，其从远侧转折点155的中心延伸至近侧转折点166的中心。此外，弯曲部分133可以包括具有长度a的远侧区段135，其从切削刃112延伸至远侧转折点155的中心。此外，在“s形”的远端可以有远侧角度1，在“s形”的近端可以有近侧角度2。可以调节这些长度(a、b)和角度(1、2)以实现期望的拐弯或偏置以便得到与组织壁的最佳同位关系(apposition)。例如，长度a可以比长度b短以确保刀具尽可能接近角度1，从而提供刀具303的更好的同位关系。角度1和2可以在120度与180度之间，比如在140度与160度之间。在一个示例中，对于被配置为用于具有2.5至4mm直径的血管中的导管，长度a在5mm与10mm之间，长度b在10mm与15mm之间，角度1为140度，角度2为160度。
弯曲部分133可以有利地沿径向将导管的远端推抵血管壁200，从而使得能够最佳地对图1B所示的血管进行切割和/或成像。
图3A-图3B示出示例导管300的另一实施例，其包括在导管主体中将斑块切除刀具抵向血管壁的弯曲部分333。弯曲部分333可以具有与弯曲部分133相似的尺寸和特征。然而，与导管100的固定拐弯弯曲部分133相反，弯曲部分333可以是用户激活的拐弯。因此，参照图3A和图3B，可以通过内轴313(其可为刀具的驱动轴)与外轴311之间的拉伸和压缩相互作用来将导管300偏转进入弯曲部分333，内轴313和外轴311在远端处被固定在一起，但在近端处可相对于彼此自由移动。外轴311可包括加强构件377a、377b，比如被配置为将偏转偏置为设定形状的镍钛合金或不锈钢的加强构件。如图3B所示，可存在可轴向地与外轴311对齐并且轴向地和径向地偏置于彼此的两个加强构件377a、377b。结果，当将压缩力施加在外轴311上时(比如通过拉拽内轴313或单独的拉线或轴)，与加强构件377a、377b相对的外轴的部分379a、379b将会收缩。两个部分379a、379b的收缩将导致与图1所示的导管100相似的s形。结果，导管将会偏转成拐弯或s形构造，其中轴的远端偏置于并平行于主轴主体。将会理解的是，其他数量和布置的加强构件也是可以的，其他所得的拐弯形状也是如此。
在图4A-图4B中示出了包括用户激活的弯曲部分433的斑块切除导管400的另一实施例。斑块切除导管400包括细长主体401、附接至其上的头锥405、以及被配置为暴露从中穿过的环形刀具411的切割窗口407。此外，导管400包括弯曲部分433。弯曲部分433包括相反曲率(即，一个向上弯曲，另一个向下弯曲)的弯曲区段425、426，以形成近似s形。在一个实施例中，s形可被配置为使得导管主体401的远端和/或头锥405偏置于但基本上平行于导管主体401的近端。在另一实施例中，细长主体401的远端和/或头锥405相对于导管主体401的近端形成一角度。
因此，如图4B所示，拐弯433的“s形”可具有近侧弯曲区段426以及具有长度c的远侧弯曲区段425。此外，在“s形”的远端可存在远侧角度1，在“s形”的近端可存在近侧角度2。可调节拐弯433的长度(c、d)和角度(1、2)以实现期望的拐弯或偏置，以便得到与组织壁的最佳同位关系。例如，角度1和2可在120度与175度之间，比如在140度与160度之间。此外，在一些实施例中，近侧区段426的长度d大于远侧区段425的长度c。在一个实施例中，对于被配置为用在具有2.5至4mm的直径的血管中的导管，长度c为5mm，长度d为8mm，角度1和2为150度。弯曲部分433可被配置为在导管的使用期间采取s形，如上文关于弯曲部分333所描述的那样。
图5A-图5D中示出了示例的用户激活的弯曲部分533(例如，用作弯曲部分433)。弯曲部分533可包括框架(例如，由镍钛合金或不锈钢制成)，该框架包括沿着弯曲区段525、526内的细长主体501的圆周构型的一系列周向狭缝550(例如，激光切口)。弯曲区段525、526的框架还可包括延伸通过框架的纵向脊部560a、560b。纵向脊部560a、560b可定位为彼此呈大约180度(即，在细长主体501的相对侧上)，并且基本上平行于细长主体501的纵向中心轴线延伸。框架还可包括将两个弯曲区段525、526分离的周向脊部561。每个脊部560a、560b和561由其中不包括狭缝的基本上为一块实体的材料形成。在使用时，随着周向狭缝550在弯曲期间压缩和/或彼此重叠，纵向脊部560a、560b形成了弯曲区段525、526的支柱。此外，在一些实施例中，框架可在其上方和/或其下方层压有诸如薄聚合物层(比如Tecothane)之类的层。在其他实施例中，不对框架进行层压以提供更大灵活性。
参照图5D，狭缝550可布置为这样的构型：其被配置为在维持细长主体的结构整体性的同时提供灵活性。因此，大多数狭缝550可具有相同长度，但彼此偏置。例如，在远侧区段525中的狭缝可布置在行(1,2)和列(A,B)中。每个狭缝550(除了与脊部560a邻接的较短狭缝以外)的长度可与列A+B+A的宽度相等。此外，狭缝可彼此偏置距离A+B。因此，每一列A可包括来自每一行1、2的狭缝，而列B可包括交替的狭缝(来自行1或来自行2)。因此，列B提供了装置的带狭缝部分的结构整体性。区段526中的狭缝可类似地布置，但可偏置以使得每一列C(具有来自每一行3、4的狭缝)与每一列D(具有来自行3或行4的狭缝)的中心轴线对齐。该偏置有助于对导管提供在其弯折时的稳定性。
在一些实例中，推动或拉拽导管的轴(比如刀具驱动轴、拉轴、或拉线)可激活弯曲部分533。即，随着轴向近侧被拉回，其可在外部细长主体501上施加压缩力，使得在脊部560a、560b保持其长度的同时狭缝550压缩和/或在彼此上方移动。所得s形(见图4B)允许刀具(正处于脊部460a远侧)被推向血管壁。
图5A-图5D所示的狭缝550为重复的、对称的构型。然而，该构型无需对称。在一些实施例中，狭缝可全具有相同长度。在其他实施例中，一些狭缝比其他狭缝长。在一个实施例中，狭缝宽.0016”且长.0575”，与下一行狭缝偏置.0035”。
具有更大程度的狭缝的导管主体的各区域将会比具有更小程度的狭缝的那些更灵活。在一些实施例中，狭缝可一直延伸通过细长导管。在其他实例中，一些狭缝可以比其他狭缝深或浅，这也影响到对应区域的灵活性。在弯曲部分的一些变型中，可以实现灵活片段之间的一系列偏转。可以通过狭缝的不同几何构型、狭缝的不同间隔、狭缝的频度、狭缝的大小等来实现这一点。在一些实例中，可以通过在某些区域中添加各种长度的附加脊部或对脊部的宽度进行调整来调整刚度。
参照图6A-图6E，示出了另一示例弯曲部分633(例如，用作弯曲部分433)。弯曲部分633包括具有通过两个纵向脊部660a、660b被连接到一起的三个环形圈脊部661a、661b、661c的框架。纵向脊部661a、661b、661c可彼此呈大约180°。在一些实施例中，如图6C所示，在远侧的圈661a、661b、661c可在远端具有斜角以允许头锥605的脱下(dropping)或拧转(pivoting)。此外，环形圈脊部661a、661b、661c与纵向脊部660a、660b之间的间隔可为打开的或被切掉(即，不包括框架材料)。在一些实施例中，可利用一个或多个薄聚合物层(比如Tecothane)将框架层压至细长主体601。圈661a、661b、661c可在其中包括用于将机构633焊接或层压至导管的细长主体的孔洞。在其他实施例中，框架可保持不被层压，以提供更大灵活性。当对机构633施加压缩力时，机构633可从每个脊部633弯折开，形成了s形。
参照图7A和图7B，在一些实施例中，斑块切除导管700可包括弯曲部分777，其包括固定拐弯区段707和柔性区段717。固定拐弯区段707可在柔性区段717近侧(如图所示)或在柔性区段717远侧。在一些实施例中，固定拐弯区段707比柔性区段717长。例如，固定拐弯区段707可为5mm至10mm，比如为8mm，柔性区段717可为2mm至6mm，比如为5mm。此外，在一些实施例中(如图所示)，固定拐弯区段707可仅包括单个弯曲而不是双弯曲(例如，形成c形而不是s形)。弯曲的角度例如可为120°至175°，比如130°至160°，比如大约145°。柔性区段717可被配置为在使用期间(即，在受到血管壁的作用时)被动地弯折，例如形成在90°与180°之间的角度，比如110°至170°的角度，比如130°至160°的角度。
在一些实施例中，弯曲部分777可由层压的框架制成。参照图7B，弯曲部分777可包括包含了延伸通过其的多个周向狭缝750a、750b的框架。柔性区段717的狭缝750a可围绕整个圆周延伸(即，其中不包括纵向脊部)，而固定拐弯区段707的狭缝750b可在延伸通过固定拐弯区段707的纵向脊部760处结束。环形脊部761可将柔性区段717和固定拐弯区段707分离。框架例如可由镍钛合金或不锈钢制成。此外，框架可在一侧或两侧上层压有聚合物薄层，比如Tecothane。在一些实施例中，仅固定拐弯区段707被层压，而柔性区段717保持不被层压。
参照图7B，狭缝750a、750b可布置为这样的构型：其被配置为在维持细长主体在柔性区段717和固定拐弯区段707两者中的结构整体性的同时提供柔性区段717中的灵活性。因此，大多数狭缝750a、750b可具有相同长度，但彼此偏置。例如，在柔性区段717中的狭缝750a可布置在行(1,2)和列(A,B)中。每个狭缝750a的长度可与列A+B+A的宽度相等。此外，狭缝可彼此偏置距离A+B。因此，每一列A可包括来自每一行1、2的狭缝，而列B可包括交替的狭缝(来自行1或来自行2)。因此，列B提供了装置的带狭缝部分的结构整体性。柔性区段717的狭缝750a可提供灵活性以允许导管700在人体之内时实现在任意方向上的期望曲率(即，狭缝在弯曲的外部时可被拉开，并且在弯曲的内部时可压缩和/或重叠)。例如，柔性区段717可弯折以将刀具与血管的边缘对齐。
此外，固定拐弯区段707中的狭缝750b(除了与脊部560a邻接的较短狭缝以外)同样可具有与列A+B+A的宽度相等的长度。此外，狭缝可彼此偏置距离A+B。因此，每一列A可包括来自每一行1、2的狭缝，而列B可包括交替的狭缝(来自行1或来自行2)。然而，在固定拐弯区段707中，脊部760可被热定型以设置拐弯的角度，固定该拐弯。
参照图8A，在一些实施例中，头锥805可为柔性的。即，细长主体可包括一个或多个弯曲(如本文所述)，头锥805可提供附加的灵活性以允许导管具有期望形状。头锥805例如可包括覆盖在层压层中的重复激光切口构型。如图8A所示，该构型可包括围绕头锥的圆周延伸的一系列螺旋狭缝850。一些实施例中，激光切口构型可以是由不锈钢切出来的，不锈钢可层压有聚合物(比如Tecothane)。附加的柔性头锥设计在以下中有描述：2015年9月15日提交的题为“TISSUE COLLECTION DEVICE FOR CATHETER”的美国专利申请No.14/776,749、现在的美国专利申请公开No.2016-0008025-A1，以及2017年6月1日提交的题为“CATHETER DEVICE WITH DETACHABLE DISTAL END”的国际专利申请No.PCT/US2017/035510，它们均通过引用全文并入本文。还可附加地或替代本文所述的细长主体弯曲部分的任何特征来使用柔性头锥。
在一些实施例中，本文所述的细长导管主体的弯曲部分可形成具有曲率相反的两个不同转折点的大致s形。在其他实施例中，弯曲部分可包括形成大致C形的单个转折点。此外，在一些实施例中，弯曲中的一个或多个可以是固定的。在其他实施例中，弯曲中的一个或多个可以是用户激活的(例如，通过拉驱动轴或单独的拉轴或线)。此外，本文所述的任何设计可包括允许导管在使用期间采取期望曲率的柔性区段(例如，细长主体或头锥的柔性区段)。
在一些实施例中，可在斑块切除手术过程之前或期间基于动脉的曲率和斑块形成的位置来进一步调整用户所调整的弯曲部分的曲率的量。例如，通过拉伸导管的轴，弯曲部分会收缩并采用更锐利的角度。替代地，当轴放松时，弯曲部分会放松并采用更宽的角度。在这样的示例中，偏转的角度例如可被调整5至20度。
在一些实施例中，用户调整的弯曲部分可具有预成形的弯折或曲率，其可在斑块切除手术过程之前或期间被进一步调整。在其他实施例中，在用户激活的弯折被激活之前，弯曲部分可以是笔直的。
在本文所述的任何实施例中，头锥可被配置为保持由刀具进行减积的组织。此外，驱动轴和刀具可被配置为向远侧移动以将组织挤入头锥中。
在一些实施例中，框架的层压会导致层压材料发热和起皱，推入打开的狭缝并固定框架的形状(例如，成为预成形的拐弯)。例如，可对弯曲部分533和/或633进行层压以产生固定拐弯，该固定拐弯可通过拉驱动轴来进一步调整，或者在整个手术过程保持固定。在其他实施例中，框架的层压可使得狭缝保持打开且没有材料，允许更大灵活性。
本文所述的任何弯曲部分可单独使用或与用于偏转头锥的机构相结合地使用。在一些实施例中，可通过拉刀具驱动轴来偏转头锥。这种偏转机构在以下中有描述：2016年3月16日提交的题为“ATHERECTOMY CATHETERS DEVICES HAVING MULTI-CHANNEL BUSHINGS”的美国专利申请No.15/072,272、现在的美国专利No.9,592,075，以及2016年3月21日提交的题为“ATHERECTOMY CATHETERS AND OCCLUSION CROSSING DEVICES”的美国专利申请No.15/076,568、现在的美国专利No.9/498,247，它们均通过引用全文并入。在一些实施例中，对驱动轴进一步施加拉力(即，在暴露头锥之后)会导致对弯曲部分施加压缩力，使得弯曲部分采取其最终弯曲构型。具有头锥偏转和弯曲部分两者会带来更好的组织内陷，因而更好的或更有效的组织切割。
在头锥没有偏转的实施例中，可对相应切割窗口最优化，以允许组织自动内陷于切割窗口中。此外，使头锥不偏转并使组织同位完全依赖于弯曲部分可在挤入期间有利地防止刀具脱离头锥。此外，仅具有弯曲部分(即，不具有头锥激活)可有利地消除了使用附加机构在手术中促使得到拐弯(比如拉拽或推动轴)的必要，从而提高使用便利性并提高图像稳定性。
本文所述的具有弯曲部分的斑块切除导管有利地允许斑块切除刀具对于靠近动脉内壁的斑块更容易和更近的定位。即，弯曲部分可被配置为使得刀具的暴露部分(例如，延伸通过刀具窗口的区域)比刀具的未暴露侧移动得更接近于血管壁。该定位可使得斑块切除手术过程期间的切割更有效。
当本文中一个特征或元件被称为在另一特征或元件“上”时，其可直接在所述其他特征或元件上，或者也可存在中间特征和/或元件。相反，当一个特征或元件被称为“直接”在另一特征或元件“上”时，不存在中间特征或元件。还将理解的是，当一个特征或元件被称为“连接”、“附接”或“耦接”至另一特征或元件时，其可直接连接、附接或耦接至所述另一特征或元件，也可以存在中间特征或元件。相反，当一个特征或元件被称为“直接连接”、“直接附接”或“直接耦接”至另一特征或元件时，不存在中间特征或元件。尽管是关于一个实施例被描述或示出的，但所描述或示出的特征和元件可应用于其他实施例。本领域技术人员还将理解，提及被布置为与另一特征“相邻”的结构或特征可以具有重叠在该相邻特征上或在其下的部分。
本文使用的术语目的仅在于描述特定实施例，而不旨在限制本发明。例如，如本文所使用的，单数形式“一个”、“一”和“该”旨在也包括复数形式，除非上下文另有明确指示。还将理解，术语“包括”和/或“包括……的”当用在本说明书中时，指明存在所述的特征、步骤、操作、元件和/或部件，但不排除存在或添加一个或多个其他特征、步骤、操作、元件、部件和/或它们的组。如本文所使用的，术语“和/或”包括列出的相关条目中的一个或多个的任何和所有组合，并且可被缩写为“/”。
为便于描述在本文中可使用诸如“在……下”、“下方”、“下”、“在……上方”、“上”等空间相关术语来描述附图中示出的一个元件或特征与其他(多个)元件或特征的关系。将会理解，除了附图所示的定向，空间相关术语旨在还涵盖装置在使用中或在操作中的不同定向。例如，如果图中的装置倒转，则描述为在其他元件或特征“下方”或“之下”的元件将会定位为在所述其他元件或特征“上方”。因此，示例术语“下方”可涵盖上方和下方两种定向。装置可以按其他方式定向(旋转90度或其他定向)，可相应地解释本文使用的空间相关描述语。类似地，本文使用的术语“向上”、“向下”、“垂直的”、“水平的”等目的仅在于说明，除非另有具体指示。
尽管本文可能使用了术语“第一”和“第二”来描述各种特征/元件(包括步骤)，然而这些特征/元件不应被这些术语限制，除非上下文另有所指。这些术语可用于将一个特征/元件与另一特征/远近区分。因此，下文讨论的第一特征/元件可称为第二特征/元件，类似地，下文讨论的第二特征/元件可被称为第一特征/元件而不脱离本发明的教导。
在整个本说明书及后续权利要求书中，除非上下文另有要求，否则词语“包括”以及诸如“包含”和“包括……的”之类的变体意指各种部件在方法和物件(例如，包括装置和方法的组合和设备)中可共同地采用。例如，术语“包括……的”将理解为表明包括任何所述元件或步骤，但不排除其他任何元件或步骤。
如本文在说明书和权利要求书中所使用的，包括在示例中使用的，并且除非另有明确说明，否则所有数字均可视为以词语“大约”、“近似”为前缀，即使该术语并未明确出现。词语“大约”或“近似”可在描述数量和/或位置时用来指示所述值和/或位置在值和/或位置的合理预期范围之内。例如，数字值可具有为所述值的+/-0.1％的值(或值的范围)、所述值的+/-1％的值(或值的范围)、所述值的+/-2％的值(或值的范围)、所述值的+/-5％的值(或值的范围)、所述值的+/-10％的值(或值的范围)，等等。本文记载的任何数字范围旨在包括其中归入的所有子范围。
尽管上文描述的各种例示性实施例，然而可以在不脱离由权利要求所述的本发明范围的情况下对各种实施例作出任何许多变化。例如，执行各种所述方法步骤的顺序在替代实施例中通常可改变，并且在其他替代实施例中可完全跳过一个或多个方法步骤。各种装置和系统实施例的可选特征可包括在一些实施例中而不包括在其他实施例中。因此，前述描述主要出于示例目的而提供，不应被视为对权利要求所阐述的本发明范围的限制。
本文包括的示例和图示通过例示性的方式而非限制性的方式示出了可实施主题的特定实施例。如所提及的那样，可以使用和从中导出其他实施例，使得可作出结构和逻辑替代和变化而不脱离本公开的范围。如果实际上公开的多于一个发明，则发明主题的这种实施例仅出于方便而在本文中可单独地称为或统称为术语“发明”，而不旨在自发地将本申请的范围限制于任何单个发明或发明构思。因此，尽管本文已经例示和描述了特定实施例，但精心设计来实现相同目的的任何布置可替代所示的特定实施例。本公开旨在覆盖各种实施例的任何和所有改版或变型。上述实施例以及本文未具体描述的其他实施例对于阅览了上面描述的本领域技术人员而言将会是明显的。

Claims (33)

1.一种用于血管中的斑块切除导管，包括：
细长导管主体；
环形刀具；
其中所述细长导管主体包括具有预设曲率的固定拐弯区段和具有比所述细长导管主体的其余部分大的灵活性的柔性区段，其中所述固定拐弯区段和柔性区段由其中包括多个周向狭缝的框架形成。
2.根据权利要求1所述的斑块切除导管，其中，所述固定拐弯区段中的框架还包括从其延伸通过的不具有狭缝的纵向脊部。
3.根据权利要求1所述的斑块切除导管，还包括所述环形刀具延伸通过的切割窗口，所述切割窗口位于所述固定拐弯区段和所述柔性区段的远侧，以将所述刀具抵入血管中。
4.根据权利要求1所述的斑块切除导管，还包括位于所述固定拐弯区段的框架上方或下方的至少一个层压层。
5.根据权利要求4所述的斑块切除导管，其中，所述层压层由聚合物制成。
6.根据权利要求1所述的斑块切除导管，其中，所述框架由金属制成。
7.根据权利要求1所述的斑块切除导管，其中，所述多个周向狭缝布置成重复构型。
8.根据权利要求1所述的斑块切除导管，其中，所述固定拐弯区段在所述细长导管主体中形成130°至160°的角度。
9.根据权利要求1所述的斑块切除导管，其中，所述框架还包括不具有狭缝的环形脊部，所述环形脊部在所述固定拐弯区段与所述柔性区段之间延伸。
10.根据权利要求1所述的斑块切除导管，其中，所述柔性区段被配置为被动地弯折至130°至160°的角度。
11.一种用于血管中的斑块切除导管，包括：
细长导管主体；
环形刀具；以及
在所述细长导管主体中的s形弯曲部分，所述弯曲部分包括框架，所述框架具有通过纵向近侧脊部和纵向远侧脊部连接在一起的多个环形脊部，所述纵向近侧脊部与所述纵向远侧脊部呈大约180度定位。
12.根据权利要求11所述的斑块切除导管，其中，所述多个环形脊部包括第一环形脊部、第二环形脊部和第三环形脊部，所述纵向近侧脊部连接所述第一环形脊部和所述第二环形脊部，并且所述纵向远侧脊部连接所述第二环形脊部和所述第三环形脊部。
13.根据权利要求11所述的斑块切除导管，还包括所述环形刀具延伸通过的切割窗口，所述切割窗口定位于所述弯曲部分的远侧且在所述s形弯曲的外圆周上，以将所述刀具抵入所述血管中。
14.根据权利要求11所述的斑块切除导管，其中，所述s形弯曲部分被配置为通过拉拽或推动所述斑块切除导管的轴而被激活。
15.根据权利要求11所述的斑块切除导管，还包括定位在所述框架上方或下方的至少一个层压层。
16.根据权利要求15所述的斑块切除导管，其中，所述层压层由聚合物制成。
17.根据权利要求11所述的斑块切除导管，其中，所述框架由金属制成。
18.根据权利要求11所述的斑块切除导管，其中，所述纵向远侧脊部相邻于所述刀具的暴露部分而定位。
19.根据权利要求18所述的斑块切除导管，其中，所述纵向远侧脊部与所述刀具的所述暴露部分在所述细长导管主体的同一侧上。
20.根据权利要求11所述的斑块切除导管，其中，所述纵向近侧脊部形成第一角度，并且其中所述纵向远侧脊部形成第二角度，所述第一角度和所述第二角度在相反方向上延伸，并且其中所述第一角度在140与160度之间，所述第二角度在140与160度之间。
21.根据权利要求11所述的斑块切除导管，其中，所述多个脊部中的最远侧脊部包括具有斜角的远侧边缘。
22.根据权利要求21所述的斑块切除导管，还包括头锥，其被配置为从所述细长主体拧转脱离以暴露所述刀具，所述斜角被配置为提供用于所述头锥拧转的空间。
23.一种用于血管中的斑块切除导管，包括：
细长导管主体；
环形刀具；以及
在所述细长导管主体中的s形弯曲部分，所述弯曲部分包括具有近侧区段和远侧区段的框架，所述近侧区段具有多个周向近侧狭缝和不具有狭缝的纵向近侧脊部，所述远侧区段具有多个周向远侧狭缝和不具有狭缝的纵向远侧脊部，所述纵向近侧脊部与所述纵向远侧脊部呈大约180度定位。
24.根据权利要求23所述的斑块切除导管，还包括所述环形刀具延伸通过的切割窗口，所述切割窗口定位于所述远侧区段的远侧且在所述s形弯曲的外圆周上，以将所述刀具抵入所述血管中。
25.根据权利要求23所述的斑块切除导管，其中，所述s形弯曲部分被配置为通过拉拽或推动所述斑块切除导管的轴而被激活。
26.根据权利要求23所述的斑块切除导管，还包括定位在所述框架上方或下方的至少一个层压层。
27.根据权利要求26所述的斑块切除导管，其中，所述层压层由聚合物制成。
28.根据权利要求23所述的斑块切除导管，其中，所述框架由金属制成。
29.根据权利要求23所述的斑块切除导管，其中，所述多个周向近侧狭缝布置为第一重复构型，并且其中所述多个周向远侧狭缝布置为第二重复构型，所述第一重复构型和所述第二重复构型在周向上彼此偏置。
30.根据权利要求23所述的斑块切除导管，其中，所述纵向远侧脊部相邻于所述刀具的暴露部分而定位。
31.根据权利要求30所述的斑块切除导管，其中，所述纵向远侧脊部与所述刀具的所述暴露部分在所述细长导管主体的同一侧上。
32.根据权利要求23所述的斑块切除导管，其中，所述近侧区段形成第一角度，并且其中所述远侧区段形成第二角度，所述第一角度和所述第二角度在相反方向上延伸，并且其中所述第一角度在140与160度之间，所述第二角度在140度与160度之间。
33.根据权利要求23所述的斑块切除导管，其中，所述框架还包括在所述近侧区段与所述远侧区段之间延伸的不具有狭缝的环形脊部。
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US20250040957A1 (en) 2025-02-06
US12161360B2 (en) 2024-12-10
US20220071656A1 (en) 2022-03-10
EP3478190A4 (en) 2020-01-22
CN109414273B (zh) 2023-02-17
WO2018006041A1 (en) 2018-01-04
JP2019520914A (ja) 2019-07-25
US11224459B2 (en) 2022-01-18
EP3478190B1 (en) 2023-03-15
JP7061080B2 (ja) 2022-04-27
US20190209206A1 (en) 2019-07-11

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