CN102014773A - 用于开通阻塞的血管通道的导管系统和方法 - Google Patents

用于开通阻塞的血管通道的导管系统和方法 Download PDF

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CN102014773A
CN102014773A CN2009801142435A CN200980114243A CN102014773A CN 102014773 A CN102014773 A CN 102014773A CN 2009801142435 A CN2009801142435 A CN 2009801142435A CN 200980114243 A CN200980114243 A CN 200980114243A CN 102014773 A CN102014773 A CN 102014773A
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H·N·帕特尔
J·B·辛普森
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
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    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
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    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing

Abstract

本发明公开了一种旋转切割头部导管，其用于穿过患病的动脉中的慢性完全闭塞或其他顽固的动脉粥样硬化斑块。当不使用时，导管的旋转的切割头部被设计为安全地容纳在外部保护护套中。外部保护护套包括一个或多个螺旋形的槽或狭缝，且切割头部包括配合在这些螺旋形的槽或狭缝中的突出的刀锋或突起。向附接至切割头部的内部导管或金属丝施加转矩使得切割头部旋转，且护套的螺旋形的槽或狭缝对切割头部的突出的刀锋或突起的力将切割头部推出保护护套。一旦延伸，切割头部可以自由地旋转。该装置可以使用导丝来引导切割头部到达希望的位置。

Description

用于开通阻塞的血管通道的导管系统和方法
技术领域
本发明涉及用于开通阻塞的血管通道的导管系统和方法。
背景技术
很多血管疾病，例如冠状动脉疾病和外周血管疾病，是由于动脉中脂肪粥样硬化沉积(斑块)而引起的。这些沉积限制血液流动至由特定动脉所供给的组织。这类疾病的风险因素包括高龄、糖尿病、高血压、肥胖、吸烟史、以及高胆固醇或甘油三酸酯。
当沉积形成在心脏动脉中时，这种疾病被称为冠状动脉疾病(CAD)。当这些沉积形成在四肢(例如腿)的动脉中时，这种症状被称为外周血管疾病(PAD)。CAD的症状，包括心绞痛、心脏病和心脏病发作是公知的。PAD的症状可以包括行走时疼痛、以及不愈合的伤口。如果PAD未受治疗，可能最终导致严重肢端缺血(CLI)、坏疽以及肢体损失。70岁以上的人大约有30％都患有PAD。
当斑块堆积达到动脉被完全堵塞的程度，这种闭塞被称为慢性完全闭塞(CTO)。CTO可能会使CAD的治疗挫败，因为心脏肌肉的突然丧失可能导致猝死。阻塞外周动脉的CTO对于PAD患者来说也是极为严重的。遭受CTO的PAD患者通常会持续恶化以至死亡。外周动脉中的CTO通常导致肢体坏疽，这需要通过截肢来解决。截肢又会导致其他并发症，因此所有PAD患者在截肢后两年内约有一半会死亡。
因此对于CAD和晚期PAD，迅速治疗阻塞物是非常重要的。此时，更少侵入性的血管成形术或粥样斑块切除术具有很多优点。在这些手术中，导管被插入患病动脉中并且穿过阻塞区域。然后这些阻塞物可以由充气的导管气囊(气囊血管成形术)的压力挤压至有希望更加开阔的位置处，或者阻塞区域可以通过支架来保持开放，或者替代地医生可以使用导管通过外科手术从动脉内侧去除斑块(粥样斑块切除术)。
作为例子，对于PAD的治疗，通常使用诸如Fox Hollow(现在是ev3)SilverHawkTM导管(美国专利6027514)的粥样斑块切除术装置。这些导管可以沿着动脉穿入(通常在导丝的辅助下)至阻塞区域。在阻塞区域，医生通常定位导管以多次经过动脉的阻塞区域，每次经过可以刮走一条斑块。刮走的斑块条存储在装置的空心突起中。通过多次经过，可以基本上减少斑块，肢体中可以恢复血液循环从而不需要截肢。
但是，为了有效地治疗斑块，需要最现代的导管穿过动脉的阻塞区域。这是因为大多数导管的用于治疗阻塞物的有效部分通常位于导管的侧面而非导管的尖端。这仅仅是因为简单的机械需要。导管的尖端必须具有非常小的表面积，因此仅能够治疗患病动脉的非常小的部分。相反，导管侧面可以具有大得多的表面积，因此导管侧面与患病动脉的侧面良好地符合。因此，支架、气囊、粥样斑块切除工具等通常安装在导管的侧面。导管必须穿过动脉的阻塞部分以正常工作。
当动脉仅部分地被斑块阻塞时，通常操纵导管经过闭塞，且由此导管的有效部分能够与动脉的患病部分相接触。但是，当动脉被完全阻塞时，例如在CTO的情况下，这一选择不再可能。导管的尖端遇到闭塞从而阻止其进一步向前运动。
简单地试图迫使普通导管经过闭塞通常是不可能的。闭塞通常由相对坚韧的纤维物质构成，这通常也包括硬质的钙沉积。通常，当医生试图迫使导丝或导管经过这种闭塞时，导丝或导管装置可能反而穿过动脉进入动脉外的体腔。这会进一步损伤动脉，使得手术复杂化并且降低手术成功几率。如前面所讨论的，这种手术的失败后果具有高死亡率。因此，使得导管和导丝能够更容易地穿过硬化的斑块和CTO的改进的方法具有很高的医疗重要性。
在Aziz和Ramsdale发表于Heart 2005；91；42-48的文章“Chronictotal occlusions-a stiff challenge requiring a major breakthrough：isthere light at the end of the tunnel？”中可以找到对本领域的现有技术状况的很好的概括。
制造切割通过硬化的斑块的装置的已有尝试包括授权予Lary的美国专利5556405、授权予Curry的美国专利6152938、以及授权予Delaney等人的美国专利6730063。
专利5556405教导了一种切割导管，其特征是存储在导管壳体内的具有刀锋的头部，导管壳体具有多个槽且刀锋从槽中伸出。刀锋通过推拉导管致动。当推拉导管被推时，刀锋头部从壳体的槽中伸出，且由此刀锋与硬化的斑块物质接触。刀锋并不旋转，而是执行线性的切割。
专利6152938教导了一种用于打开多种不同的阻塞(闭塞)管的通用的导管钻孔装置。该装置将钻头的尖端抵靠闭塞面固定，使用附接至钻头的控制绳部分地转动钻头，使得钻头成角度地朝向。
专利6730063教导了一种用于化学地处理钙化的血管闭塞的导管装置。该装置是流体输送导管，其将酸性溶液和其他流体输送至钙化的斑块处，以化学地溶解钙化的物质。
Cordis Corporation、FlowCardia Technology、Kensey NashCorporation和其他公司目前销售数种用于横穿CTO闭塞的导管装置。Cordis Corporation、Johnson and Johnson Company生产XP CTO导管(之前由LuMend Corporation生产)。这种导管在美国专利6800085和其他专利中讨论过，其具有前部“钳口”，当钳口横穿导管时进行张合运动。钳口本身并不切割，而是在导管经过时试图撬开CTO。
其他导管装置使用多种形式的引导能量横穿CTO。例如，FlowCardia Technology、Sunnyvale California生产Crosser系统，这在美国专利7297131和其他专利中有教导。该系统使用超声换能器以将能量输送至非切割性的导管头部。该导管头部自身具有相对小的直径并且不具有任何刀锋。而是通过高速(超声)振动使头部穿过多种不同的闭塞。
Kensey Nash Corporation、Exton Pennsylvania(前IntraluminalTherapeutics，Inc.)生产Safe-Cross CTO系统。该系统在美国专利6852109和7288087中教导，其使用射频(RF)能量。该导管自身也通过光学(近红外光)传感器引导其运动，该光学传感器能够感测导管的尖端何时靠近动脉壁。光学传感器告诉操作者如何引导导管，且RF烧蚀单元帮助操作者烧蚀物质并穿过闭塞区域。
虽然这些装置设计巧妙，但是它们的成功率仍然有待提高。根据Aziz所述，现有技术的装置克服CTO的有报导的最高成功率在56％到75％的范围内。Aziz还教导，平均成功率仅在50％到60％的范围内。考虑到未成功清除CTO对患者病情和死亡率的严重负面影响，很明显需要进一步改进。
这些现有技术的CTO清除装置的另外的问题是，简单地切割出穿过CTO的小的通道并不足以完全解决医疗问题。有时，横穿CTO的装置应当也移除(去除)大部分闭塞。这是因为，如前文所讨论的，可能需要移除大部分闭塞以使得具有侧面安装的支架、气囊和粥样斑块切除工具的导管能够接近动脉的损坏部分并进行更持久的修复。因此，能够去除更大量的CTO以使得其他类型的导管能够经过的改进的CTO“畅通”装置也是希望的。
因此，需要能够有效地横穿CTO并且移除更大量的硬化或钙化斑块的装置。这种装置将使得支架和其他装置(例如SilverHawk粥样斑块切除导管、气囊导管等)能够更成功地应用于严重闭塞情况。这又会导致患者状况改进以及患者病情减轻和死亡率下降。
发明内容
本发明教导一种新颖的旋转切割头导管，其用于形成穿过患病的动脉、静脉、或其他体腔中的诸如慢性完全闭塞、顽固粥样硬化斑块、胆结石、肾结石等的顽固物质的通道。当不使用时，导管的旋转的切割头部被设计为安全地容纳在外部的保护护套头部中，且该护套头部安装在导管的远端。
外部的保护护套头部包括一个或多个螺旋形的槽或狭缝，且切割头部包括配合在这些螺旋形的槽或狭缝中的突出刀锋或突起。向内部的转矩传递连接件(附接至切割头部的导管或金属丝或线圈或任何转矩传递机构)施加转矩能够使得切割头部转动，且护套头部的螺旋形槽对切割头部的突出刀锋或突起的力使得切割头部从保护护套向外推进。一旦延伸出来，切割头部能够自由旋转。在一些实施方式中，导管以及甚至切割头部自身的中央可以是空心的，且装置可以使用导丝来引导导管和切割头部至希望的位置。替代地，导丝可以附接至引导件，引导件附接至导管管部的外侧。在至少一些实施方式中，护套头部起止动器的作用，并且可以包括被设计为限制切割头部向前延伸的一个或多个止动元件(例如机械障碍物)。
根据切割头部的突出刀锋的角度和属性，刀锋可以被设计为仅仅切穿堵塞的物质而不实际从体腔中去除堵塞的物质，或者替代地刀锋可以被设计为既切穿堵塞的物质，并且切断其与体腔的连接从而将堵塞的物质从体腔中去除。在该情况下，切割头部可以作用以实际地移除(去除)大部分闭塞。
附图说明
图1示出包括手柄、导管和导管头部的导管装置的整体视图。
图2示出切割头部从护套头部延伸出时导管头部的外部视图。
图3示出切割头部延伸并且切入堵塞动脉中的CTO斑块时导管头部(安装在导丝上)的视图。
图4示出切割头部从导管头部的护套头部的保护罩旋下的示意图。
图5示出导管头部的放大图，示出切割头部旋入导管头部的保护护套头部内的存储位置。
图6示出具有替代的突出的刀锋设计的切割头部的放大图。
具体实施方式
虽然在本发明的讨论中，通常使用此类装置在动脉、特别是冠状动脉或外周肢动脉中形成穿过顽固的动脉粥样硬化斑块的应用作为例子，但是应当理解这些特定的例子并不是限制性的。本技术的其他应用可以包括：去除肾结石，在该情况下装置将横穿输尿管；去除胆结石，在该情况下装置将横穿胆管；去除尿道的前列腺肥大阻塞，在该情况下装置将横穿尿道；去除输卵管阻塞，在该情况下装置将横穿输卵管；治疗凝血、去除捕获在肺中的物质，等等。总的来说，可以通过这些技术以外科手术方式去除不希望地占据体腔中的空间的任何物质。类似地，虽然在大部分例子中引述了在人类患者中的应用，但是很明显，同样的技术对于动物也是有用的。
螺旋钻头和自攻螺钉头在穿过像蜡一样软以及像石头和金属一样顽固的物质方面是非常有效的，而且事实上这些装置在这些方面的应用也是很广泛的。虽然钻头是有效的，但是它们也通常被认为是有力的且非常粗笨的。任何曾经试图使用过电钻的人可以证明，虽然公认钻孔装置在去除物质方面很有效，但是它们看起来完全不适于精细的血管手术，特别是在隐藏在体内深处的位置。螺旋自攻螺钉头的设计略微不同。虽然在切穿多种物质方面同样有效，钻头被配置为切割然后移除物质，而自攻螺钉头被设计为主要用于在物质中切出通道。对于任一种类型的装置，问题都不在于切割或去除闭塞的效力；问题在于防止疏忽而对周围动脉造成损伤。
但是，令人惊讶地，本发明教导，如果克服了对这种粗笨且强有力的方法的偏见，并设计适合的保护和控制装置来控制这种“钻头”装置的粗笨并且显然过大的动力，可以生产出既能有力地切割或去除闭塞，又确定足以避免对动脉壁造成不希望的损伤的适于精细的血管手术的导管“钻头”装置。
因此，在本发明的第一方面，将类似“钻头”的物质去除装置(或自攻螺纹螺钉头)的优秀的物质切割/移除属性与使得这种强有力的切割装置能够安全并且有效地在精细的动脉和其他体腔的限制下使用的适当的保护和导管引导机构相结合。
为此，必须在“钻头”的切割边缘上施加精确的控制。钻头部或“切割头部”通常应当被护套套住或被遮蔽以不与动脉壁接触，使得当导管的头部穿入动脉至闭塞区域时避免因疏忽对动脉壁造成损伤。一旦到达闭塞处，切割头部(钻头部)的切割部分应当选择性地仅露出至执行相关的闭塞切割活动所需要的最小的程度。切割头部的旋转方向可以可选地变化，例如通过逆时针旋转头部以产生穿过障碍或闭塞的钝切开，然后在将头部拉回到整个组件上的同时使其顺时针旋转。一旦形成希望的切割，切割头部应当迅速返回至其保护护套中。整个装置应当在普通的动脉的毫米级直径中操作，并且应当能够穿在导管上以进入身体相当长的距离。
在下述附图和例子中教导实现这些目标的适合的技术。
图1示出包括导管主体102、导管手柄104和导管头部106的导管装置100的整体视图。导管主体和导管头部，以及甚至切割头部，通常是空心的并且能够容纳导丝(未示出)。也示出了导管头部的放大图，示出了处于延伸配置的旋转的切割头部108延伸出导管头部106的护套部分(这里该护套被称为“护套头部”)。
图2示出切割头部108延伸时导管头部106的护套头部的外部视图。该切割头部通常具有一个或多个突出的侧面刀锋或切割边缘202，并且通常也额外地具有前面切割边缘204。导管头部106的护套部分和导管102的中央可以是空心的以容纳导丝。在一些实施方式中，导丝通过侧面开口(未示出)在导管头部106的侧面上在切割头部108之前离开导管头部106的护套部分。在其他的实施方式中，切割头部108自身是空心的，且导丝通过开口206离开切割头部108的端部。
在关闭的配置中，旋转的切割头部108缩回到导管头部106的护套头部中，且切割头部108的切割边缘或突起202容纳在螺旋形的狭缝或槽208中。这种护套的配置防止突出的侧面切割边缘202和前面切割边缘204意外地接触动脉壁。
图3示出导管头部106切入堵塞的动脉306中的CTO 304中的视图(且切割头部从护套头部延伸)。在该例子中，导管和导管头部安装在导丝302上并且由导丝302引导，但是并不都是这种情况。
应当清楚，类似“钻头/螺钉”的切割头部的切割边缘会很容易损伤动脉306的内层。为了避免这种意外的损伤，需要对切割头部的暴露程度进行精确的控制。图4中示出了实现这种精确控制的方法。
图4示出切割头部108如何从导管头部106的护套头部的螺旋形的狭缝或槽208中旋出从而暴露出切割边缘202和204的一些细节。在配置402中，示出切割头部108完全暴露。切割头部从螺旋形狭缝208中完全旋出并且完全延伸。安装在切割头部108上的可选的突出柱或引导件404可以作用以引导旋转的切割头部进出螺旋形的螺纹狭缝208。将切割头部108与转矩传递内部导管管部或线缆408联接起来的联接器(转矩传递连接件)406处于导管头部106的护套头部内侧的最远位置处。
在配置410中，示出切割头部处于完全缩回位置。切割头部通常被储存在该完全缩回位置下，使得它能够通过导丝被引入动脉中并且被引导至闭塞或斑块区域，而不损伤动脉的非目标区域。注意联接器406处于导管头部106的护套头部的最远位置，且切割头部108的突出的切割刀锋202被完全旋入螺旋形的螺纹狭缝208中。
在一些情况下，引导至闭塞处的导丝(图3中302)已经被引入。事实上，之前可能已经尝试过执行粥样斑块切除术，并且该尝试由于顽固的斑块(例如覆盖着硬质钙化沉积的斑块)而失败，此时医生可能决定使用本切割装置来穿过所述顽固的斑块。
在使用时，导管头部106和导管管部102附接至导丝，并且然后通过适当的切口被引入动脉。导管手柄104将保持在体外。闭塞的位置通常是已知的，并且事实上可以通过荧光检查或其他技术对闭塞成像。将导管头部106引到闭塞处，然后操作员将通常通过安装在导管手柄104上的装置施加转矩。该转矩通常通过内部转矩传递导管或金属丝408(这里称为“转矩传递连接件”)传递至导管头部106。外部导管102通常不传递转矩。外部导管102保持基本静止(即不旋转)，且类似地导管头部106的护套头部和螺旋形的螺纹狭缝或槽208也不旋转。
转矩通过联接器406传递至切割头部108。该转矩基本导致切割头部108通过突出的刀锋边缘202抵靠螺旋形的狭缝或槽208的作用而从导管头部106的护套头部中的缩回位置“旋出”。该“旋出”的圆周运动由弧形箭头412示出。随着切割头部108旋出，它开始推进并伸出保护护套头部罩的外侧。
在配置420中，示出切割头部108处于部分旋出或部分延伸的位置。注意突出的刀锋边缘202已经相对于螺旋形的护套头部螺纹狭缝或槽208移动。因此，刀锋边缘202现在部分地从螺旋形的螺纹狭缝208中旋出并且部分地暴露。现在切割头部108从导管头部106的壳体或罩的护套头部中伸出，且联接器406部分地朝向导管的远端移动。
很明显，当希望时可以通过反转转矩的方向将切割头部再次缩回护套头部中。导管可以被重新定位以进行下一次切割，且切割头部延伸、切割和缩回的过程可以重复必要的次数。
因此，本发明通过每次仅将切割头部暴露出当前任务所需要的量来控制“钻头”切割头部的侵犯性的切割动力。
图5示出导管头部的护套头部的放大图，示出切割头部旋入保护护套头部罩内的储存位置。该角度使得能够容易地看到螺旋形的螺纹狭缝或槽208，且也可以看到位于导管头部106的护套头部内的切割头部108。
图6示出替代的切割头部108设计的放大图，其中切割头部108具有螺旋形的突出的切割边缘202。
导管头部106的护套头部的直径通常在约1到2.2毫米之间，且导管主体102通常也具有约1到3毫米(3到9弗伦奇)的直径以及在50到200cm之间的长度。护套头部可以由多种材料制成，例如硬质塑料、金属或复合材料。这种材料的例子包括NiTi钢、铂/铱或不锈钢。
虽然护套头部106包含被设计为当切割头部旋转时向切割头部108施加向前的运动的狭缝或槽，且这些狭缝或槽被称为“螺旋形”的狭缝或槽，但是因为护套头部和整个导管头部的长度很短，狭缝或槽并不必要是精确的数学螺旋形状。事实上，与数学上的纯螺旋形配置或多或少不同的多种形状都能够满足。总的来说，狭缝或槽必须使得施加于切割头部的转矩导致切割头部旋转和推进，并且任何这种狭缝或槽在这里被称为“螺旋形的”狭缝或槽。同样，在本讨论中，“狭缝”被认为是从空心的导管头部106的内侧延伸到外侧的开口，而“槽”与来福线槽类似，即“槽”不从空心的护套头部的内侧一直延伸到外侧，而是仅部分地穿过护套头部材料。
切割头部108通常由诸如钢、碳化物或陶瓷的材料制成。切割头部的刀锋202、204可以可选地通过涂覆碳化钨、ME-92等得到硬化。美国专利4771774、5312425和5674232中公开了适用于该目的的材料。根据头部是否仅用于切穿闭塞的物质或者用于切穿并实际地移除(去除)部分闭塞，刀锋的角度以及它们的设计的细节会不一样。例如，用于移除物质的刀锋可以成角度地弯曲以使得它们倾向于切断闭塞的物质与体腔之间的连接，而仅用于切割的刀锋将具有倾向于不切断连接的替代的角度。
在一些实施方式中，导管可以由两种不同的管部构成。在该配置中，可以有外部导管管部102，其通常由柔性的生物适应的材料制成。也可以具有内部管部408，其具有将转矩从导管手柄104(通过联接器406)传递至切割头部108的能力。内部转矩传递管部(这是“转矩传递连接件”的一种可能的类型)能够相对于外部导管管部扭转，使得当转矩在手柄端部104施加到内部管部时，切割头部108将旋转，但是连接至外部导管管部的导管护套头部本身将保持基本静止。替代地，可以使用线缆替代内部管部408。
为此，外部导管主体102通常可以由有机聚合物材料挤压形成，例如聚酯、聚四氟乙烯(PTFE)、聚氨酯、聚氯乙烯、硅橡胶等。内部转矩传递导管408可以由这些材料制成，或者替代地可以由金属线圈、金属丝或细线构成。
在很多实施方式中，导管被设计为与单轨导丝相配合，单轨导丝的直径为约0.014”，或者在0.010”到0.032”之间。例如，外部导管套可以包括用于单轨导丝的附接的外部引导件。在该情况下，导丝可以在导管头部之前或者在导管头部中途离开这些外部引导件。替代地，导管可以是空心的，并且在导管的整个长度上位于导丝上。
导管手柄104通常附接到外部导管管部102和内部管部或线缆408。通常手柄104包括使得操作者能够向内部转矩传递管部或线缆408施加转矩的至少一个把手、转盘或控制杆。在一些实施方式中，可以使用传感器来确定切割头部108已经相对于导管头部106的护套头部旋转或延伸的量，且这些传感器通常可能在机械或电子的计算和显示机构辅助下向操作者显示切割头部已经旋转或者延伸的量。
在一些实施方式中，导管手柄104将被设计为具有联接至机械机构(例如齿轮、转矩传递带等)的把手或控制杆，机械机构手动地旋转并且推进/缩回导管尖端，且操作者将轻柔缓慢地转动或移动这些把手或控制杆以手动控制尖端。在其他的实施方式中，导管手柄将包含诸如电子马达的机构，以及诸如按钮或触发器的控制装置，从而允许使用者以精确和受控的方式转动和推进切割头部。该机构可以例如包括微处理器或反馈控制马达、微处理器、和软件，从而可以作用以从切割头部旋转或延伸传感器接收信息，并且使用该旋转反馈数据结合通过按钮或触发器所发送的操作者指示，从而针对每次操作员指令以精确的量推进或缩回切割头部。这样操作员不需要担心由于内部转矩传递管部或线缆408的弹簧作用而导致的任何误差。微处理器(或其他电路)所控制的马达可以自动地对这些误差进行补偿，将按钮或触发器按压转换为正确的转矩量并且不需要操作员进一步动作地执行指令。替代地，诸如游标或一系列引导标记等的非微处理器方法可以用于使得操作员能够补偿转矩传递连接件的旋转和切割头部的旋转之间的差，或者补偿所述切割头部伸出所述空心的护套头部的程度。
在一些实施方式中，导管头部可以装备有额外的传感器，例如用于感测钙化物质的超声传感器、用于感测闭塞或动脉壁的光学(近红外)传感器、或其他医疗相关传感器。如果使用这些传感器，在一些情况下，将用于这些传感器的驱动机构也定位在导管手柄104中是适宜的。
还可以使用用于改进切割头部的效用的额外的装置。由此，切割头部可以被配置为以高频(超声)振动、执行射频(RF)组织烧蚀、产生局部高温区域、传导切割光线(例如激光或准分子激光)或其他引导的能量的装置。
切割头部可以由替代的设计和材料构成，且这些设计和材料可以被选择以解决当前的特定问题。例如，适于针对钙化闭塞使用的切割头部可能与适于针对非钙化闭塞使用的切割头部不同。类似地，适于针对高纤维性闭塞使用的切割头部对于较低纤维性和较高脂肪性的闭塞可能不太适合。闭塞的长度或尺寸也可以影响头部设计。
虽然多种导管(每种由不同类型的切割头部构成)可以处理这类问题，在其他的情况下，包括单个导管和多个切割头部108以及可选的多个护套头部106的套装可能更加经济。在这种情况下，切割头部108可以被设计为容易地从联接器406上安装和拆卸。医生可以通过荧光或其他技术看到闭塞并且选择最适用于当前问题的切割头部设计(以及相关联的护套头部设计)。替代地，如果切割头部108上的刀锋202、204已经变钝或由于在手术中使用而破裂，医生可以选择用新的切割头部替换变钝的或破裂的切割头部108，同时继续使用导管的其他部分。
在一些应用中，使用导管为闭塞供应多种视觉染料或治疗剂可能是有用的。这里，染料或治疗剂可以通过外部导管102和内部转矩导管408之间的空间，或者替代地如果转矩导管408是空心的可以经转矩导管408的内部输送至导管头部。如果切割头部108也具有空心的开口206，则染料或治疗剂可以直接被输送至闭塞，甚至在切割头部108切穿闭塞的同时。
施加的有用的染料和治疗剂的例子包括荧光检查、超声、MRI、荧光或冷光轨迹和视觉染料、抗凝剂(例如肝素、低分子量肝素)、凝血酶抑制体、抗血小板剂(例如环氧酶抑制剂、ADP受体抑制剂、磷酸二酯酶抑制剂、糖蛋白IIB/IIIA抑制剂、腺苷重吸收抑制剂)、抗促凝血酶原激酶剂、诸如溶解血栓剂(例如组织血纤维蛋白溶酶原激活物、尿激酶、溶栓酶)的抗血栓剂、酯酶、单克隆抗体等。
在一些实施方式中，以具有不同于用于构建导管头部的空心的护套头部的材料的不透辐射特征(在X射线下具有不同的外表)的材料制成切割头部可能是有用的。这使得医生能够通过荧光检查或其他x射线成像技术直接看到切割头部已经伸出导管护套头部的量。
权利要求书(按照条约第19条的修改)
1.一种用于输送导丝穿过闭塞的导管，包括：
导管管部；
可旋转的切割头部，其包括螺旋形突起；
保护性的护套，其位于所述导管管部的远端，包括穿过所述护套的侧壁向近侧延伸的一个或多个螺旋形的狭缝，其中，可旋转的所述切割头部能够通过将所述螺旋形突起旋出所述狭缝以从保护性的所述护套向远侧延伸；
转矩传递连接件，其能够从所述导管的近端向可旋转的所述切割头部施加转矩，以旋转所述切割头部并使所述切割头部向远侧向前至少部分地向保护性的所述护套外侧延伸；以及
导丝通道，其穿过所述导管管部从近侧向远侧延伸。
2.根据权利要求1所述的导管，其中，一个或多个螺旋形的所述狭缝沿着保护性的所述护套的侧面部分向近侧延伸。
3.根据权利要求1所述的导管，其中，所述切割头部的向前延伸受到一个或多个止动元件的限制。
4.根据权利要求1所述的导管，其中，所述切割头部的向前延伸不受所述导管管部的限制。
5.根据权利要求1所述的导管，其中，所述导管管部包含转矩传递连接件，且其中向所述转矩传递连接件施加转矩导致可旋转的所述切割头部旋转。
6.根据权利要求1所述的导管，其中，所述转矩传递连接件包括反馈控制的电子马达。
7.根据权利要求1所述的导管，其中，所述导丝通道被配置为在远侧通过可旋转的所述切割头部的中央的开口离开。
8.根据权利要求1所述的导管，其中，所述导丝通道被配置为在远侧所述导管管部的容纳可旋转的所述切割头部的部分之前离开所述导管。
9.根据权利要求1所述的导管，其中，可旋转的所述切割头部包含一个或多个刀锋边缘。
10.根据权利要求1所述的导管，还包括监控所述切割头部延伸出所述导管的过程的传感器。
11.根据权利要求1所述的导管，还包括通过发出超声振动、射频(RF)能量或光能以加强所述切割头部的切割效率的换能器。
12.根据权利要求1所述的导管，其中，所述切割头部具有与所述导管的不透辐射特征不同的不透辐射特征。
13.一种用于输送导丝穿过闭塞的导管，包括：
导管管部；
空心的护套，其位于所述导管管部的远侧部分并且包括穿过所述护套的侧壁向近侧延伸的一个或多个螺旋形的狭缝；
可旋转的切割头部，其定位为至少部分地位于空心的所述护套头部内，其中，可旋转的所述切割头部能够通过旋出空心的所述护套的所述狭缝以从空心的所述护套向远侧延伸以及缩回空心的所述护套中；
转矩传递连接件，其能够施加转矩以从所述导管的远端旋转可旋转的所述切割头部；以及
导丝通道，其穿过所述导管管部延伸并且延伸出空心的所述护套的远端。
14.根据权利要求13所述的导管，其中，可旋转的所述切割头部包含至少一个螺旋形的突起，所述突起能够与螺旋形的所述狭缝接合，以使得可旋转的所述切割头部上的至少一个所述突起与一个或多个螺旋形的所述狭缝之间的相互机械作用将所述切割头部推出或推入空心的所述护套头部。
15.根据权利要求13所述的导管，其中，所述导管管部和所述转矩传递连接件是空心的，且所述导丝通道穿过所述导管管部和所述转矩传递连接件延伸。
16.根据权利要求13所述的导管，还包括能够向所述转矩传递连接件施加转矩以旋转可旋转的所述切割头部的反馈控制的电子马达。
17.根据权利要求13所述的导管，其中，所述导丝通道被配置为在远侧通过可旋转的所述切割头部的中央的开口离开。
18.根据权利要求13所述的导管，其中，可旋转的所述切割头部包含一个或多个刀锋边缘。
19.根据权利要求13所述的导管，还包括测量所述切割头部推进伸出空心的所述护套头部的过程的传感器。
20.根据权利要求13所述的导管，还包括通过发出超声振动、射频(RF)能量或光能以加强所述切割头部的切割效率的换能器。
21.根据权利要求13所述的导管，其中，所述切割头部具有与空心的所述护套头部的不透辐射特征不同的不透辐射特征。
22.一种用于输送导丝穿过闭塞的导管，包括：
空心的导管管部；
空心的护套头部，其固定在所述导管管部的远侧部分；空心的所述护套头部包含开口和一个或多个螺旋形的狭缝或槽；
可旋转的切割头部，其定位为至少部分地位于空心的所述护套头部内；可旋转的所述切割头部包含能够与螺旋形的所述狭缝或槽接合的至少一个突起；
转矩传递连接件，其中，向所述转矩传递连接件施加转矩导致可旋转的所述切割头部旋转；以及
导丝通道，其穿过所述导管管部且穿过可旋转的所述切割头部延伸。
23.根据权利要求22所述的导管，还包括微处理器控制的电子马达，其中微处理器控制的所述电子马达能够补偿所述电动马达的旋转与所述切割头部的旋转之间的旋转差。
24.根据权利要求22所述的导管，其中，可旋转的所述切割头部包含一个或多个刀锋边缘。
25.根据权利要求22所述的导管，还包括监控所述切割头部推进伸出空心的所述护套头部的开口的过程的传感器。
26.根据权利要求22所述的导管，其中，所述切割头部具有与空心的所述护套头部的不透辐射特征不同的不透辐射特征。
27.一种输送导丝穿过血管腔中的动脉粥样硬化闭塞或病变的方法，所述方法包括：
将导管管部穿过所述血管腔至所述闭塞或病变处；
旋转定位在所述导管管部内的转矩传递连接件以旋转位于所述导管管部的远端的可旋转的切割头部，其中，所述切割头部包括一个或多个螺旋形的突起；
从所述导管管部的远端处的护套头部延伸可旋转的所述切割头部，所述护套头部包括穿过所述护套头部的侧壁的一个或多个螺旋形的狭缝，当所述切割头部缩回时所述护套头部能够遮蔽可旋转的所述切割头部使其不与所述血管腔和所述闭塞或病变接触；
推进所述导管管部穿过所述闭塞或病变以切割堵塞的材料并且不移除堵塞的材料；以及
将导丝穿过导丝通道，所述导丝通道穿过所述导管管部向远侧延伸。
28.根据权利要求27所述的方法，其中，所述转矩传递连接件的旋转被调节为对所述转矩传递连接件的旋转与所述切割头部的旋转之间的差进行补偿。
29.根据权利要求27所述的方法，还包括通过所述导管管部分配治疗剂或视觉染料剂。
30.根据权利要求27所述的方法，其中，在延伸所述导丝之前，将所述导管管部穿过所述血管病变。
31.根据权利要求27所述的方法，其中，所述闭塞或病变通过安装在可旋转的所述切割头部上的一个或多个刀锋边缘切割。
32.根据权利要求27所述的方法，还包括对所述切割头部、闭塞或损伤施加超声振动、射频(RF)能量或光能。
33.根据权利要求27所述的方法，其中，所述方法被用于将导丝穿过阻塞的冠状动脉或外周肢动脉插入，且在同一个手术中接着通过动脉粥样斑块切除术、植入支架、或气囊血管成形术对所述阻塞的动脉进行进一步治疗。

Claims (47)

1.一种导管，包括导管管部和可旋转的切割头部；
可旋转的所述切割头部定位在所述导管管部内；
其中，施加于可旋转的所述切割头部的转矩导致所述切割头部与所述导管管部相互作用，从而导致所述切割头部旋转并且向前至少部分地向所述导管管部外侧延伸。
2.根据权利要求1所述的导管，其中，所述切割头部包含至少一个突起，且所述导管管部包含一个或多个狭缝或槽；
其中，所述切割头部上的所述至少一个突起与所述一个或多个狭缝或槽之间的相互机械作用导致所述切割头部旋转并且向前至少部分地向所述导管管部外侧延伸。
3.根据权利要求1所述的导管，其中，所述一个或多个狭缝或槽中的至少一些是螺旋形的。
4.根据权利要求1所述的导管，其中，所述切割头部的向前延伸受到附接至所述导管管部的一个或多个止动元件的限制。
5.根据权利要求1所述的导管，其中，所述切割头部的向前延伸不受所述导管管部的限制。
6.根据权利要求1所述的导管，其中，所述导管管部是空心的，并且包含转矩传递连接件，且其中向所述转矩传递连接件施加转矩导致可旋转的所述切割头部旋转。
7.根据权利要求6所述的导管，其中，转矩通过手动机构或者通过反馈控制的电子马达施加至所述转矩传递连接件。
8.根据权利要求6所述的导管，其中，通过空心的所述导管管部分配治疗剂或视觉染料剂。
9.根据权利要求6所述的导管，其中，导丝穿过空心的所述导管管部内部，且其中所述导丝通过可旋转的所述切割头部的中央的开口离开空心的管部。
10.根据权利要求1所述的导管，其中，仅所述导管管部的一部分容纳可旋转的所述切割头部，且导丝穿过附接至所述导管管部外侧的引导件，且其中所述导丝在所述导管管部的容纳可旋转的所述切割头部的所述一部分之前离开所述引导件。
11.根据权利要求1所述的导管，其中，可旋转的所述切割头部包含一个或多个刀锋边缘。
12.根据权利要求1所述的导管，其中，所述切割头部延伸出所述导管的过程由传感器监控。
12.根据权利要求1所述的导管，其中，所述切割头部的切割效率通过超声振动、射频(RF)能量或光能加强。
13.根据权利要求1所述的导管，其中，所述切割头部具有与所述导管的不透辐射特征不同的不透辐射特征。
14.根据权利要求1所述的导管，其中，所述导管被用于从冠状动脉或外周肢动脉中去除顽固的动脉粥样硬化斑块或慢性完全闭塞。
15.根据权利要求14所述的导管，其中，所述导管被用作阻塞的冠状动脉或外周肢动脉的预处理，且其中在使用所述导管之后所述阻塞的动脉接着接受粥样斑块切除术、植入支架、或气囊血管成形术。
16.一种导管，包括：
导管管部；
空心的护套头部，其固定在所述导管管部的远侧部分；以及
可旋转的切割头部，其定位为至少部分地位于空心的所述护套头部内；
其中，所述切割头部的旋转导致所述切割头部与所述护套头部相互机械作用，从而导致所述切割头部旋转并且进一步推进至空心的所述护套头部的外侧。
17.根据权利要求16所述的导管，其中，空心的所述护套头部包含开口和一个或多个螺旋形的狭缝或槽；
可旋转的所述切割头部包含能够与螺旋形的所述狭缝或槽接合的至少一个突起；
且其中可旋转的所述切割头部上的所述至少一个突起与一个或多个螺旋形的所述狭缝或槽之间的相互机械作用导致所述切割头部旋转并且推进通过空心的所述护套头部中的所述开口。
18.根据权利要求16所述的导管，其中，所述导管管部是空心的并且包含转矩传递连接件，且其中向所述转矩传递连接件施加转矩导致可旋转的所述切割头部旋转。
19.根据权利要求18所述的导管，其中，所述转矩通过手动机构或通过反馈控制的电子马达施加于所述转矩传递连接件。
19.根据权利要求18所述的导管，其中，通过空心的所述导管管部分配治疗剂或视觉染料剂。
20.根据权利要求18所述的导管，其中，导丝穿过空心的所述导管管部内部，且其中所述导丝通过可旋转的所述切割头部的中央的开口离开空心的管部。
21.根据权利要求18所述的导管，其中，导丝穿过附接至所述导管管部外侧的引导件，且其中所述导丝在空心的所述护套头部之前、或者通过空心的所述护套头部的侧面上的开口离开所述引导件。
22.根据权利要求16所述的导管，其中，可旋转的所述切割头部包含一个或多个刀锋边缘。
23.根据权利要求16所述的导管，其中，所述切割头部推进伸出空心的所述护套头部的开口的过程由传感器监控。
24.根据权利要求16所述的导管，其中，所述切割头部的切割效率通过超声振动、射频(RF)能量或光能加强。
25.根据权利要求16所述的导管，其中，所述切割头部具有与空心的所述护套头部的不透辐射特征不同的不透辐射特征。
26.根据权利要求16所述的导管，其中，所述导管被用于从冠状动脉或外周肢动脉中去除顽固的动脉粥样硬化斑块或慢性完全闭塞。
27.根据权利要求26所述的导管，其中，所述导管被用作阻塞的冠状动脉或外周肢动脉的预处理，且其中在使用所述导管之后阻塞的动脉接着接受粥样斑块切除术、植入支架、或气囊血管成形术。
28.一种导管，包括：
空心的导管管部；
空心的护套头部，其固定在所述导管管部的远侧部分；
空心的所述护套头部包含开口和一个或多个螺旋形的狭缝或槽；
可旋转的切割头部，其定位为至少部分地位于空心的所述护套头部内；
可旋转的所述切割头部包含能够与螺旋形的所述狭缝或槽接合的至少一个突起；
转矩传递连接件，其中，向所述转矩传递连接件施加转矩导致可旋转的所述切割头部旋转；
其中，可旋转的所述切割头部上的所述至少一个突起与一个或多个螺旋形的所述狭缝或槽之间的相互机械作用导致所述切割头部旋转并且推进通过空心的所述护套头部中的所述开口。
29.根据权利要求28所述的导管，其中，转矩手动地、或者通过微处理器控制的电子马达施加于所述转矩传递连接件，且其中微处理器控制的所述电子马达补偿所述电动马达的旋转与所述切割头部的旋转之间的旋转差。
30.根据权利要求28所述的导管，其中，通过空心的所述导管管部分配治疗剂或视觉染料剂。
31.根据权利要求28所述的导管，其中，导丝穿过空心的所述导管管部内部，且其中所述导丝通过可旋转的所述切割头部的中央的开口离开空心的管部。
32.根据权利要求28所述的导管，其中，导丝穿过附接至所述导管管部外侧的引导件，且其中所述导丝在空心的所述护套头部之前、或者通过空心的所述护套头部的侧面的开口离开所述引导件。
33.根据权利要求28所述的导管，其中，可旋转的所述切割头部包含一个或多个刀锋边缘。
34.根据权利要求28所述的导管，其中，所述切割头部推进伸出空心的所述护套头部的开口的过程由传感器监控。
35.根据权利要求28所述的导管，其中，所述切割头部的切割效率通过超声振动、射频(RF)能量或光能加强。
36.根据权利要求28所述的导管，其中，所述切割头部具有与空心的所述护套头部的不透辐射特征不同的不透辐射特征。
37.根据权利要求28所述的导管，其中，所述导管被用于从冠状动脉或外周肢动脉中去除顽固的动脉粥样硬化斑块或慢性完全闭塞。
38.根据权利要求37所述的导管，其中，所述导管被用作阻塞的冠状动脉或外周肢动脉的预处理，且其中在使用所述导管之后阻塞的动脉接着接受粥样硬化斑块切除术、植入支架、或气囊血管成形术。
39.一种治疗血管腔中的动脉粥样硬化闭塞或病变的方法，所述方法包括：
将导管管部穿过所述血管腔至所述闭塞或病变处；
旋转安装在所述导管管部内的转矩传递连接件；
所述转矩传递连接件连接至安装在所述导管管部的远端上的空心护套头部内的可旋转的切割头部，所述护套头部遮蔽可旋转的所述切割头部使得当没有进行所述旋转时可旋转的所述切割头部不与所述血管腔和所述闭塞或病变接触；
其中，可旋转的所述切割头部和空心的所述护套头部之间的相互机械作用导致所述切割头部旋转并且至少部分地离开空心的所述护套头部，从而使得旋转的可旋转的所述切割头部与所述闭塞或病变接触并且切割所述闭塞或病变。
40.根据权利要求39所述的方法，其中，空心的所述护套头部包含开口和一个或多个螺旋形的狭缝或槽；
可旋转的所述切割头部包含能够与螺旋形的所述狭缝或槽接合的至少一个突起；
且其中可旋转的所述切割头部上的所述至少一个突起与一个或多个螺旋形的所述狭缝或槽之间的相互机械作用导致所述切割头部旋转并且推进通过空心的所述护套头部中的所述开口。
41.根据权利要求39所述的方法，其中，所述转矩传递连接件的旋转被调节为对所述转矩传递连接件的旋转与所述切割头部的旋转之间的差进行补偿，或者对所述切割头部伸出空心的所述护套头部的程度进行补偿。
42.根据权利要求39所述的方法，其中，所述导管管部是空心的。
43.根据权利要求42所述的方法，还包括通过空心的所述导管管部分配治疗剂或视觉染料剂。
44.根据权利要求39所述的方法，其中，所述导管管部使用导丝穿过所述血管病变。
45.根据权利要求39所述的方法，其中，所述闭塞或病变通过安装在可旋转的所述切割头部上的一个或多个刀锋边缘切割。
46.根据权利要求39所述的方法，还包括对所述切割头部、闭塞或损伤施加超声振动、射频(RF)能量或光能。
47.根据权利要求39所述的方法，其中，所述方法被用作阻塞的冠状动脉或外周肢动脉的预处理，且在同一个手术中接着通过动脉粥样斑块切除术、植入支架、或气囊血管成形术对所述阻塞的动脉进行进一步治疗。
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