CN101076290A - 主动脉瓣修复 - Google Patents

主动脉瓣修复 Download PDF

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CN101076290A
CN101076290A CNA2005800425231A CN200580042523A CN101076290A CN 101076290 A CN101076290 A CN 101076290A CN A2005800425231 A CNA2005800425231 A CN A2005800425231A CN 200580042523 A CN200580042523 A CN 200580042523A CN 101076290 A CN101076290 A CN 101076290A
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valve
conduit
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汉森·S·吉福德
马克·E·迪姆
斯蒂芬·博伊德
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Abstract

本发明提供一种用于对主动脉瓣去钙化的装置和方法。本发明的方法和装置通过对钙化部位施加热能或从其除去热能在该主动脉瓣上和围绕该主动脉瓣破裂或清除钙化沉积物。

Description

主动脉瓣修复
背景技术
主动脉瓣狭窄在美国是导致每年大约65,000例主动脉瓣置换手术的常见疾病。主动脉瓣狭窄能够由多种病因引起，包括风湿病、先天和变性的钙化狭窄。在发展中国家，风湿热导致瓣膜组织变厚和逐渐的不动性。在风湿病很少的美国和发达国家钙化病变是造成主动脉狭窄的几乎是全部原因。
随着时间过去，钙的聚集能够在瓣膜环上、沿着小叶尖以及在小叶上或小叶内发生。诸如结节状钙化沉积的钙化物质可以重叠在下面的纤维变性的主动脉瓣小叶上或钙化沉积物可以分散地分布在主动脉瓣小叶的整个体(松质)内。虽然沉积物的分布和类型可以根据瓣膜的几何形状(二尖瓣、三尖瓣)而不同，但是沉积物通常导致小叶不动性、变厚以及瓣膜功能退化的其它病状。这种疾病的出现和发展导致减小瓣膜的功能面积并显著地减少心输出量。
在二十世纪八十年代后期和九十年代早期，主动脉瓣的球囊扩张或瓣膜整形术成为主动脉瓣狭窄的流行疗法。从顺行(横膈的)或逆行(主动脉)的途径利用大血管整形术球囊的主动脉瓣扩张导致左心室突出部分的改善(增加心输出)，减少整个瓣膜的压力梯度并且增加瓣膜横截面积。各种瓣膜整形球囊结构和其它途径，包括基于能量的疗法，已经公开在如下美国专利中：Lapkin的3,667,474号、Meno的4,484,579号、Hoffman的4,787,388号、Cribier的4,777,951号、Grayzel的4,878,496号和4,796,629号、Shimada的4,819,751号、Owens的4,986,830号、Schturman的5,443,446号和5,295,958号、Clayman的5,904,679号、Tower的5,362,199号和6,746,463号，这些专利的内容通过参考明确地结合与此。
此外，使瓣膜损害脱钙的各种外科手术方法试图利用超声装置清除或去掉钙化物质。这种装置包括CUSA ExelTM Surgical Aspirator和机头(23kHz和36kHz、Radionics、TYCO Healthcare、Mansfield，MA)。其它操作、方法和结果记载在下述论文中：“ContrastingHistoarchitecture of calcified leaflets from stenotic bicuspid versusstenotic tricuspid aortic valve”，Journal of American College ofCardiology 1990 Apr；15(5)：1104-8，“Ultrasonic Aortic ValveDecalcification：Serial Doppler Echocardiographic Follow Up”，Journal ofAmerican College of Cardiology 1990 Sept 16(3)：623-30，以及“Percutaneous Balloon Aortic Valvuloplasty：Antegrade Transseptal vs.Conventional Retrograde Transarterial Approach”Catheterization andCardiovascular inverventions 64：314-321(2005)，其内容通过参考明确地结合与此。
但是，这些装置和方法因增加瓣膜横截面积的能力有限而受到损害。例如，许多研究表明预先扩张约0.6cm2能够打开约0.9至1.0cm2。希望的是，打开这种狭窄到接近大约1.2至1.5cm2。除了打开横截面积之外，还希望治疗小叶和周围的环，以除去使小叶变硬的钙化沉积物，修复流动动力学和其它退化的瓣膜功能。为此，诸如直接外科手术的超声清除钙沉积物的其它技术已经取得一些成功，但是需要打开的外科切割，因此增加病人的风险。
虽然球囊扩张为病人提供一种可行的、较少侵袭的选择，但是在二十世纪九十年代早期到中期它的缺点主要是在治疗之后瓣膜很快重新变狭窄。在六个月内重新变狭窄的报告通常超过70-80％。现在，球囊心瓣整形术主要用作由于共病态状态不适合手术置换的老年病人的减轻护理。
进来，移植经皮瓣置换技术的临床技术重点已经使一些又回到心瓣整形术和主动脉瓣修复。Corazon Inc.正在研制一种隔离主动脉瓣的小叶的系统，以便保存流过该装置中心的血液，同时在整个小叶上或围绕小叶循环钙溶化剂或软化剂。例如，见美国专利公告2004/0082910，其内容通过参考明确地结合与此。希望通过软化钙减少小叶的硬度将为瓣膜的正常功能创造条件并增加心输出。该系统很复杂，需要30分钟以上的软化剂曝光时间，并且导致完全的AV堵塞并且一些病人需要植入紧急心脏起搏器。
此外，已经记载以各种方式解决主动脉瓣狭窄的其它技术。Pederson的美国专利申请公告2005/007219公开了一种用于心瓣整形术和治疗主动脉瓣的球囊材料和结构，以及环植入，其内容结合于此共参考。而且，近来，Pederson博士提出关于主动脉瓣治疗的RADRA研究的初步结果。该研究将传统的球囊心瓣整形术与外部射线辐射相结合，以试图防止治疗后发生的再狭窄。同时辐射治疗对冠状血管整形术的再狭窄已经表现出积极效果，在RADRA研究中采用的该方法需要病人经受4-6分钟的)单独的操作，初始的心瓣整形术加3-5次单独的辐射治疗时间。这些辐射治疗时间类似于用于癌症辐射治疗的时间。
在过去三年多的时间，通过引进Boston Scientific and Johnson &Johnson公司的药物洗脱支架在防止冠状球囊血管整形术和支架植入术后再狭窄方面取得显著的进展。这些装置为冠状动脉壁提供受控的和延长的抗增值剂的剂量，以处理亚急性伤口修复并防止在裸金属支架介入或者单独的血管整形术中引起再狭窄的长期增殖治疗反应。而且，在防钙化管理上取得了各种进展，包括ACE抑制剂，他汀类药物，和血管紧缩素，特别是血管紧缩素II，像美国专利申请2004/0057955中详细描述的，该申请的内容通过参考明确地结合于此。
虽然传统的方法已经证明相当成功，但是主动脉瓣狭窄和随后的心瓣整形术或其它介入之后的再狭窄仍然需要较好的解决。本发明提供各种装置和方法，其创造了更有效的动脉狭窄的治疗和防止或减少意外的和/或动脉再狭窄的严重性。此外，本发明提供去钙化或清除主动脉狭窄的装置和方法，或者作为一种单独的治疗，或者与传统的方法相结合，诸如传统的瓣膜整形术，扩张，瓣膜修复，以及经皮的或外科手术的瓣膜置换。
发明内容
本发明涉及主动脉和其他心瓣膜的修复，更具体地说，本发明涉及用于实现这种修复的脱钙的装置和方法和抗再狭窄系统。本发明可以采用不同的形式，包括设备、在主动脉修复或心瓣膜整形术时进行的急性介入、或临时或永久性植入等。
一方面，通过施加能量或去能破坏钙化作用，减少或除去瓣膜上或周围的钙化作用的方法和装置。本发明可以将超声能、RF能、机械能等施加于瓣膜翼从钙瓣膜上除去钙化作用。可选地，可以希望的是，代之以从该钙化作用去能(例如，低温冷却)以增强从瓣膜去钙化作用。在所有这些情况下，希望在贲门瓣上或贲门瓣附近的局部钙化部位形成栓塞容纳区(containment region)。这种容纳可以通过在该局部部位周围形成一种结构和/或当形成栓塞时通过从该部位主动地吸出栓塞颗粒来实现。合适的结构包括过滤器、网篮、球囊、外罩等。
本发明的另一方面。提供一种治疗导管，以对病变的瓣膜附近提供工作元件。工作元件可以包括超声元件、或能够破坏，例如，分解或清除贲门瓣上或其周围的钙化沉积物的任何其他输送机构或元件。这种装置可以是可操纵的或者是可定位的，以使使用者能够大体上引导该导管的远端，用于通过病人的动脉到瓣膜的初步放置，并且然后在治疗之前或治疗时精确地调节该放置。
另一方面，本发明提供一种治疗导管，其包括能够破坏的机械元件，例如能够机械分裂、清除并除去贲门瓣上或其周围的钙化沉积物的机械元件。类似于基于超声的导管，包括机械元件的该导管可以是可操纵的或者是带关节的以使使用者能够引导大体上引导该导管的远端的初步位置布置，并且然后在治疗时精细地调整位置。
在本发明的又一方面，也可以采用包括导引导管的系统，以作为单独的导管或作为治疗装置的一部分，将该治疗导管定位在被治疗的病变部位。在一个实施例中，主导引导管可以用于对辅助定位导管定中心，该辅助定位导管包含主动脉瓣上的治疗导管。该治疗导管可以进一步铰接以对工作端提供进一步的方向性。可以采用用于定位并稳定该治疗导管的各种其他设备和方法，包括成形球囊、网篮、或过滤器和起搏心脏的方法。
在本发明的再一方面，各种方法可以用于破坏钙化的部位，并且利用位于该治疗导管上的过滤器、位于治疗导管上的抽吸外罩、与吸出装置相连接的灌注球囊、在治疗部位或该治疗部位下游的单独的抽吸导管、单独的过滤装置，和/或外部过滤器和灌注系统从治疗部位收集和清除栓塞和其他碎屑。一些过滤器实施例可以被成形为以使治疗导管进入将被治疗的位置，同时仍然使流能够通过瓣膜(例如，一次治疗一个小叶)。
具体说，根据本发明用于治疗贲门瓣的方法包括在钙化部位形成栓塞容纳区并且提供能量(包括冷冻疗法)以破坏所述部位并且潜在地形成包含在该容纳区的栓塞。该容纳区一般直接位于通常具有有限尺寸的目标部位上，以使相关的动脉或其他血管不被阻塞或封闭。该容纳区可以用诸如钙化部位的过滤结构、网篮或球囊的屏障形成。可选地或附加地，该容纳区可以通过局部的吸出形成，以便在栓塞形成时基本上将它们全部除去。该施加的能量可以是超声的、射频的、微波的、机械的、冷冻的能量，或能够破坏瓣膜钙化物的任何其他类型的能量。
在本发明的又一方面，该方法通过使用包含微球的或微气泡的介质可以真正分裂该钙化物，例如GE Healthcare销售的OptionsTM(www.amershamhealth-us.com/option/)。对介质提供超声能量(或其他形式的能量，例如，激光、RF、热能)可以使微球破裂，这引起能量向瓣膜释放，这有助于除去瓣膜周围的钙化物。Bioeffets Caused byChange in Ascoustic Cavitation Bubble Density and Cell Concentration：AUnifed Explanation Based on Cell-to-Bubble Ratio and Blast Radius，Guzman，et al.Ultrasound in Med.& Biol.，Vol 29，No.8，pp 1211-1222(2003).
在本发明的治疗过程之前或之后可以利用某种成像和其他监测方式，利用各种技术，例如心腔内超声(ICE)、超音速回声心动描记法(TEE)、荧光检查、血管内的超声波、血管计或例如Cardio-Option，Inc.研制的利用红外技术看透血液的系统。
各种能源可以用于本发明的治疗，包括各种治疗范围内的RF，超声波能，以及机械(非超声波)能。本发明的RF、超声治疗导管和机械治疗导管的远端可以具有各种远端结构，并且可以用于各种治疗方式，并且对瓣膜内的特定位置定目标。
此外，本发明还设想心脏内的移植，包括瓣膜环、上环、下环或其组合，以帮助维持功能性的瓣膜流孔。这种移植可以包括各种药剂以增加减少再狭窄的效率，另外帮助瓣膜功能。移植可以用各种金属、可生物降解的材料，或其组合形成。
这些装置可以全部经由或者逆行方式从股动脉进入主动脉，并且从上升动脉经过瓣膜，或者通过顺行方式——横膈的(transeptal)，经过二尖瓣，通过左心室并且通过主动脉瓣。
另一方面，本发明提供用于主动脉瓣修复的抗再狭窄系统。急性介入在主动脉修复或贲门瓣整形术时进行，并且可以采取临时或永久植入的形式。
这些植入装置可以全部经由或者逆行方式从股动脉进入主动脉，然后从上升动脉经过瓣膜，并且从上升动脉经过瓣膜，或者通过顺行方式——横隔的，经过二尖瓣，通过左心室并且通过主动脉瓣，并且将提供抗再狭窄剂或能量的供给，以阻止瓣膜再狭窄或修复瓣膜再狭窄。
具体实施方式
治疗导管结构——总的
本发明的治疗导管10(图1)通常包括细长的导管主体12，该导管主体12包括近端14、远端16和在该主体内的一个或多个内腔18、20(图2)。该远端16可选地包括从导管主体12的远端径向延伸的抽吸外罩22(图4和图5)，用于在治疗时隔离小叶并且在治疗时提供碎屑排除路径，并且保护血管不受有害栓塞事件之害。能量传递元件24(例如，主动轴，金属丝导线，或波导超声传递元件等)可以设置在该细长主体12中的其中一个内腔中，并且通常从该导管主体的近端向远端延伸。把手26连接于该细长导管主体12的近端14。发生器(例如RF发生器、超声波发生器、马达、光学能源等)可以连接于该把手，以将能量提供给远端的工作端28、设置在该导管主体的内腔内的能量传递元件24。正如在这里所描述的，该远端工作元件28可以连接于能量传递元件24的远端，以便于将能量提供给主动脉瓣的钙化物。
通常，本发明的治疗导管10构造成以金属丝引导(overthe wire)方式引进到目标区。该治疗导管可以通过导引导管或护套定位在靠近该主动脉瓣。因此，本发明的治疗导管可以包括用于接纳导引金属丝GW(图2)的中心导引金属丝内腔20。在本发明的治疗导管的导引金属丝内腔20可以用于灌注或吸出该目标区。例如，虽然没有示出，但是该把手可以包括一个或多个口，以便允许目标小叶的灌注和/或目标区的灌注。灌注源和吸出源可以连接于该端口，并且目标区可以通过该导管的一个内腔被吸出。在一个实施例中，灌注源和吸出源其中之一可以连接于中心金属丝内腔(中心内腔)，而灌注源和吸出源的另一个可以连接于与该导引金属丝内腔共轴的内腔。但是，在一些实施例中，将没有内导引金属丝内腔，而该导引金属丝只是简单地通过超声波波导和旋转的主动轴延伸，如图3、图4和图6所示。
如上所术，本发明的治疗导管10可以包括设置在该导管主体远端的抽吸外罩，该外罩具有扩展的结构和收缩的结构，并且构造成与被治疗的小叶相一致。虽然该抽吸外罩22可以固定地连接于远端，但是在一个实施例中，该抽吸外罩在该收缩结构(图3)和扩展结构之间是可以移动的。单独的护套也可以是收缩的以露出该抽吸外罩并且是移动的以包围该外罩。该抽吸外罩可以用聚硅酮或尿烷制造，并且可以用内支架或网状加强结构加强，以对该瓣膜小叶的特定区域上的该外罩提供结构支撑或增强该外罩的布置。该外罩还可以用作栓塞过滤器，正如在本说明书中随后详细说明的。
在图4的实施例中，能量传递元件24向前超过该导管主体12的远端并且进入该抽吸外罩22中。导引金属丝GW设置成通过该远端上的开口。如图5所示，一旦治疗导管设置在该目标区之后，该导引金属丝GW被抽出并且远端工作元件28备用以治疗该钙化部位。
在图6中，该抽吸外罩22的形状做成与二尖瓣小叶的形状基本上一致，该外罩可以更好地构造成以隔离该目标小叶。在其他实施例中，该抽吸外罩的形状可以做成与三尖瓣的形状基本上一致(图7和图8)等。
该抽吸外罩的深度可以采取任何形式，使得它与被治疗的瓣膜相容。例如，该抽吸外罩22可以是浅的(图9)或深的(图10)。如果治疗中的小叶是冠状小叶，该杯的深度可以减少或消除干扰冠状口(ostia)。
抽吸杯/外罩在该外罩的圆周或部分圆周周围也可以具有刚性或半刚性薄膜，优选地将该杯对齐在某个瓣膜特征上，例如环。该抽吸杯/外罩具有0.1”到0.5”范围的深度和15mm到30mm的直径。该杯或外罩可以具有指状物30或纵向稳定元件32，以帮助将该外罩设置在瓣膜上，如图11、图12和图13所示。
这种稳定元件也可以是带褶的形式、环或半球元件或其他加强件以帮助该装置安置在瓣膜的环内或靠着小叶。这种加强件或稳定元件可以用不锈钢、NiTi(超弹性的或形状记忆处理的)、Elgiloy、钴铬合金、各种聚合物制成，或者可以是可充气的环形杯的形式。本发明的该杯或外罩旨在起这样的作用，提供与治疗区足够的近似，以便稳定或定位工作元件，同时还减小栓塞事件。在这种意义上它基本上密封该治疗区，但是这种密封不是必需“气密”密封，而是执行上述功能的近似。
此外，某些稳定装置36、38可以设置在主导管轴12上以在主动脉内提供稳定性，并且在一些例子中可以延伸通过在该瓣膜下面的瓣膜小叶L，以进一步稳定该治疗装置，如图14所示。
给定的从小叶到小叶、病人到病人的各种小叶的几何形状(例如尺寸。曲率)，希望的是，根据被治疗的特定的几何形状提供各种尺寸和形状的杯和外罩能够通过的主治疗导管。例如，一种系统能够包括放置在治疗区的主导引导管GC，如图15所示：该治疗区(小叶)包括冠状小叶(CL)、非冠状小叶(NCL)和非冠状小叶(中心)(NCLC)。如下面的图16所示。一旦导引导管GC到位之后，具有适于与NCL一致的远端外罩42的第一治疗导管40如箭头S1所示移动。该小叶被治疗并且NCL容纳导管GC被抽出，如S2所示。然后该导引导管位置如箭头S3所示被调整到比较接近该CL。CL容纳导管移动通过该导引装置，如箭头S4所示。一旦该CL部位被治疗，该CL容纳导管就被取出，如箭头S5所示。如图17进一步所示，然后导引导管GC被重新定位以治疗NCLC，如箭头S6所示，并且最终该NCLC容纳导管按照箭头S7移动通过该导引装置。一旦治疗完成之后，该NCLC被取出，如箭头S8所示，并且该导引装置被去掉，该过程完结。
利用这些步骤的任何一个都在本发明的范围内。以任何次序治疗该目标区，例如，可以仅仅治疗一个小叶，多于一个小叶，并且按照钙化的类型、病人的健康状况、目标区的几何形状或操作者的喜好以任何次序治疗。
超声治疗导管
根据本发明的一方面，提供一种治疗导管50，其具有用于使小叶去钙化的超声探头。超声探头52可以被框架或护套54环绕。框架和护套两者可以被连接于超声振动源(未示出)。在一些实施例中，探头52被护套或外罩围绕，该护套或外罩经由连接于该导管系统近端的抽吸源使系统能够被基本被密封在被治疗的表面上，并经由该导管主体中的抽吸内腔连接于该导管壳体。可选地，该系统可以用机械夹子或将该外罩物理地连接于治疗部位(环或小叶)的连接体放置或定位在治疗部位。在操作中，该超声探头52被起动以分裂在小叶上的钙，于是形成通过该导管主体50中的抽吸内腔可以除去的碎屑。在一些例子中，还希望将盐水或其他流体同时或应用抽吸之前灌注该外罩区域。有利的是，提供一种致冷的流体到超声波导，并且到其他实施例，诸如在该装置的远端具有PZT块的实施例。还有利的是，灌注抗钙化治疗剂到瓣膜部位，包括三价铁的和/或四价锡的盐，或本领域熟知的其他溶液，或其他使小叶抵抗钙的聚集，例如美国专利5,782,931中提出的那种类型，该专利的内容通过参考明确地结合于此。具有聚硅酮杯超声探头60的另一个实施例适于图19，其中灌注物如箭头62所示并且吸出物由箭头64所示。
在过滤装置74设置在主导管轴(示于图20)的实施例中，超声探头70可以是单独的元件，使超声治疗导管72能够在密封区域内独立地移动。该治疗探头70可以沿着各种方向以各种方式操作，这将在下面进一步详细描述，必要时，包括在治疗时沿着每个小叶的尖以圆形图形扫描并且形成同心圆，以有效的治疗整个小叶。在没有过滤装置的情况下，该超声元件可以与抽吸外罩同轴并且适于在其内独立地运动。
如图21所示，在根据本发明的另一方面中，治疗导管80可以通过一系列引导导管82、84放置，以有利于放置精度。利用该导引装置的形状第一导引件84可以放置并固定在该主动脉根部，以固定在该主动脉壁，或单独的球囊或过滤装置，以稳定该导引装置或稳定由形状记忆材料或能够提供稳定性的其他合适的材料制成的稳定环，以使该导管能够被引导到治疗部位。然后第二可操纵的或可铰接的导管82可以通过初始导引装置放置到目标瓣膜区。在一次治疗一个小叶的方法的情况下，然后该可操纵的导引装置可以被致动到下一个治疗部位的目标，因而将导引导管(和相关的过滤装置)引导到下一个位置。在治疗导管之前，可以仅仅需要放置一个导引导管，或者可选地，该治疗导管可以被操纵，使得它能够直接放置到治疗位置而不需要其他导引导管的帮助。该导引导管也可以是可操纵的并且是其他导引导管的整体部分。诸如美国专利公告2004/00922962和12004/0044350描述的可操纵的导引装置是可操纵的导引装置例子，它们的整个内容通过参考明确地结合于此。治疗装置可以重新引导到第二治疗位置，如图22所示。
本发明的治疗导管的远端部分90其形状可以做成基本上对应于目标小叶L的形状(例如，形成为配合在该小叶尖的形状内，其中外罩的开口形状做成与该小叶的形状一致，如图23所示)。这使小叶的表面能够被稳定以便治疗。该远端部分可以具有在布置和治疗时支撑该远端部分的内框架，但是是柔性的使得它折叠在治疗导管或护套内以帮助抽出。
可选地，本发明的治疗导管100可以形成具有圆周的环形的治疗表面120，以将能量/振动施加于被将被治疗的环。在这个实施例中，该导管可以放置成顺行的或逆行的，或可以使用相互结合的两个圆周治疗表面，如图24所示。
根据被治疗疾病的类型和部位可以使用各种超声工作端。例如，超声导管的远末端可以连接于超声传递件或波导。该远末端可以从下面的例子选择，包括钝头末端、斜角末端、圆形末端、尖末端，并且可以包括从末端表面突出以增强钙的破裂的任何球结节或肋(图25C)。箭头示出使用的示范性图形。
本发明超声导管的圆末端还可以采取美国专利5,304,115号中示出并描述的波导末端的形状，该专利的内容通过参考结合于此。美国专利5,989,208号(“Nito”)示出图2-图7A的一些另外的末端，其可用于除去瓣膜小叶的钙，该专利的内容通过参考结合于此。
本发明的超声传递件可以包括连接于增大的远端工作端的硬管。中心内腔可以在整个超声传递减件延伸并且可以用于吸出、抽吸和/或接收波导。在图26、27和28所示的实施例中，该增大的工作端110(其具有比细长的近部大的直径)，可以包括圆柱形部分，该圆柱形部分包括多和细长件112。在所示结构中，该细长件设置为成城堡形的图形(例如每个细长件在其中末端地延伸的圆形)并且沿着超声传递件的纵轴提供开口。虽然该细长件是圆柱形的形状，但是在其他实施例中，该细长件可以是圆形的、尖形的等。
在远端工作端的另一个实施例中，类似于上面所示的实施例，中心内腔可以延伸通过该超声传递元件并且通过该增大的远端工作端。在图29、30和31所示的结构中，该远端工作端120是细长的和圆形的。
在可选实施例中，靠近远端工作端的该超声传递元件(或波导)可以修改成以放大从该工作端输送的超声波提供。该波导可以包括在该管子(tubing)中的多个轴向狭槽，用于从该管子形成多个“细金属丝”，该金属丝使得超声波径向移动，而不是轴向移动、该增大的远端工作端于是可以被连接于多个细金属丝。这种结构的两个实施例适于图32和图33。在可选实施例中，每个城堡状结构可以安装在它自己的向后延伸到该装置近端的轴上。其他潜在的末端的几何形状在下面叙述。
本发明的超声导管可以适于对这里描述的远末端赋予运动，该运动是振荡、划点、圆的、横向的或其任何组合。对于上面描述的这种任何远末端。应用已经发现，相对于该导管主体的内径比较小的远末端提供较好的运动幅度并且可以提供改进的脱钙。此外，特别是根据被治疗的小叶或环的区域，本发明的超声末端可以以各种治疗模式操作。例如，该治疗模式由使用者在治疗装置中编程进行控制，该治疗模式可以是圆运动，以在被治疗表面上提供环形脱钙区，可以是交叉窗口(cross-hatch)图形，以破裂较大的钙沉积物(图24)，或者是半球(图36)图形，或楔形形状(图37)图形。使用上述所列的图形的任何组合或采用更多的随机图形或仅仅是线性运动，都在本发明的范围内。
某些安全机构可以包含在该治疗导管和相关组成部分上，以确保该治疗装置不穿孔，否则使小叶恶化。在一个实施例中，力限制特征可以包含在该治疗导管轴上，如图38所示，其中结构140可以响应沿着箭头144所示的方向对该导管142施加的力而收缩。
在另一个实施例中，该导管轴的特征可以限制提供给组织的力。比较刚性的导管轴152上的柔软的远末端150(图39)，其中力可以偏转该末端，如图40所示。
此外，该治疗导管200可以移动通过护套202，该护套用作该治疗导管的深度限制器，如图41和图42所示。各种安全特征可以包含在本发明的任何治疗装置中，而与采用的能量无关。
本发明的超声导管的组件示于图43，包括超声传递部件210、传递头212，导引金属丝GW，抽吸杯214、弹簧216以及导管主体218。
超声导管220的另一个实施例包括PZT块222和在该装置远端的远端喇叭224，如图44所示。
图44的实施例的优点在于消除长波导和使用长波导时发生的损耗。在这个实施例中抽吸外罩安装在该PZT块和超声喇叭上。一些有用的超声元件公开在Brisken的美国专利5,725,494号、Zalesky的5,069,664号、Cater的5,269,291号和5,318,014号，这些专利的内容通过参考明确地结合于此。
本发明的超声导管的近端可以按照图45示意地示出的结构来构造。近端壳体232上的按钮230连接于连接在该装置远端的控制线。操纵这些按钮以张紧该控制线因而操纵该远端的角度。用于可操纵的导引装置，例如齿轮、销钉和轴，的控制装置234安装在控制箱236上，其中按钮设置在该控制箱上。该治疗装置的主体还包括连接于滑动按钮的外部轴和内部轴，该内部轴在该装置的远端又可操作的连接于该壳体，使得当该滑动按钮缩回时，该壳体从缩回位置向该延伸位置移动，并且反之亦然。在图45中还示出可操作地连接于能源或主移动器的驱动轴和驱动线圈230，该能源或主移动器用于对该驱动线圈赋予运动。驱动线圈在该装置的远端端接在接触被治疗组织的工作元件。可选地，在利用超声波的结构中，超声波导或传递元件可以设置在该外轴和/或该内轴内。
机械治疗导管和方法
除了上述超声治疗导管之外，本发明还提供利用可机械地驱动的末端以机械地破坏或清除小叶上的钙的治疗导管和方法。一般而言，该导管将包括导管主体，该主体包括一个或多个内腔。驱动轴(或类似的元件)可以从该内腔的近端向该内腔的远端延伸。远端工作元件可以连接于(或一体形成于)该驱动轴并且构造成至少延伸部分地超过该导管主体的远端。该驱动轴的近端可以连接于机械运动源(旋转、振荡和/或轴向移动)以驱动该驱动轴和远端工作元件。
本发明的导管可以利用各种结构对小叶脱钙。可以利用的工作元件和导管主体的远端的一些例子在下面描述。
在一个实施例中(图46)该导管240的远端包括抽吸外罩242，该外罩可以用于接触和/或隔离被脱钙的小叶。虽然该外罩示为漏斗形形状的元件，但是在可选实施例中，该抽吸外罩具有类似于被治疗小叶的形状(如上所述)。该抽吸外罩242可以固定地连接于该导管主体240的远端，或者可以以可移动方式连接于该远端部分。在这种可移动的实施例中，该抽吸外罩可以从收缩位置(未示出)移动到扩张的结构(在下面示出)，其中在该收缩位置该抽吸外罩至少部分地设置在该导管主体的内腔内。可选地，可以用机械夹子、夹钳或其他固定元件以将该治疗装置定位在被治疗的该环或小叶处，这些固定元件在下面描述，并包括从逆行方向和顺行方向设置的元件以固定该小叶。
在图47所示的实施例中，该远端工作元件可以包括可旋转的、偏心地设置的线圈250。该线圈的远端部分沿着轴线方向逐渐变细并且在其远端或靠近其远端可以包括球体252(或其他形状的元件)。选择地，一个或多个重块元件(未示出)可以沿着线圈的各部分连接，以改变该线圈的振动动力特性。正如可以理解的，如果该重块设置成离开该线圈的纵轴，该线圈的旋转外形将改变。因此，一个或多个重块的策略性设置可以改变线圈的振动，从简单的旋转到还具有轴向振动分量的线圈。
在另一个实施例中(图48)，工作元件可以包括偏心加载的非锥形线圈260。该线圈在远末端可以包括或可以不包括球体或重块。
在再一个实施例中(图49)，该远端线圈可以包括细长的远端金属丝末端270，其中至少一部分径向延伸超过该远端线圈工作元件的外径，如图所示，该远端金属丝末端可以包括一个(或多个)球体或重块。该远端金属丝末端可以是弯曲的、直的或其组合。作为对前述远端线圈的一种替代(或附加)，该远端工作元件在远端可以包括“钻头”型叶轮或Dremel型振荡或旋转部件，其构造成接触该钙化部位并且从小叶上机械地除去钙化物。正如能够理解的，一些实施例将在非超声操作范围内旋转或振荡，其频率通常为10Hz到20000Hz，优选为100Hz到1000Hz。在一些结构中，成形的叶轮的旋转通常产生钙化物碎片，其大致朝着该导管主体内的内腔移动。在一些结构中，该叶轮可以包括圆形边以便对小叶提供一定保护。在上述每个实施例中，护套可以覆盖该旋转元件以提供保护或通过传递该旋转或传递通过该护套的轴向运动提供更加对准的力。
该工作元件还可以包括机械旋转装置。在图50的实施例中，示出一个卵形磨盘(burr)280，其取向范围从与该装置的中心线(旋转轴线)竖直对齐到与该装置的中心线成90度或以上的角度。这种偏离轴线的取向允许一定范围内的清创位置，并且对于某些情况可以更加适用，例如偏心地位于在瓣膜环内的狭窄，或者治疗相对于该装置的中心线成一定角度的小叶表面。治疗末端相对于该治疗装置的中心线成一定角度便于通过在该末端范围提供增加的速度破碎该钙化物。图51示出类似的结构，但是具有不同的形状，更加细长磨盘。此外在图52示出圆盘形式的磨盘件284，在圆盘的面上具有孔以使得通过该磨盘元件清除该碎屑。可以具有粗造表面、硬质合金末端材料、或金刚石涂覆以增强对目标物质的破碎的许多机械工作元件在本发明的范围内。代表性的磨盘元件是由多家公司制造的，例如Ditec Manufacturing(Carpenteria，CA)，Diamond Tool(Providence，RI)，以及CarbideGrinding Co.(Waukesha，WI)。
在可选的方法中，能够将叶轮元件290(图53)设置在靠近主动脉瓣并且不真正接触该小叶。该也叶轮的旋转可以引起涡流，以除去钙化的物质离开小叶并进入该抽吸外罩和该导管主体。该叶轮可以采取各种形式，例如在Kensey的美国4,747,821号专利公开的形式，该专利通过参考明确地结合于此。
在另一种结构中，旋转磨头292(图54)可以连接于远端线圈294。该旋转磨头远末端可以采取各种形状。在下面所示的一种结构中，磨头远末端是中凸的形状，并且包括绕中心开口的径向圆图形形式的多个孔，该中心通孔与该驱动轴的轴向内腔连通。在这种结构中，磨头远末端关于该远端线圈和该驱动轴的支架的纵轴线对称地设置。该径向开口允许灌注和吸出颗粒。在一些结构中，该磨头远末端可以包括研磨材料，例如金刚石粉末，以帮助从主动脉瓣除去钙化物质。
在图55和56所示的另一种磨头远末端结构中，该磨头远末端可以包括平板300。该平磨头远末端可以包括研磨材料、孔和/或机械加工的凸起或节。这种元件可以用于增强从小叶上除去钙化物。
在图57所示的可选结构中，磨头远末端304可以关于该远端线圈306偏心地安装，以便当旋转时该磨头远末端可以覆盖小叶更大的表面面积而不必加大该磨头远末端的尺寸。下面的图示出该平磨头远末端，但是应当理解，这里所述的任何远末端可以相对于远端线圈偏心地安装。
在另一个实施例中，远端工作元件可以包括城堡式的机械末端，例如上面所示的用于超声工作元件的城堡式的机械末端。可选地，该城堡式末端具有从该远末端朝后设置的叶轮。
在又一个实施例中，本发明可以用Rotablator装置对小叶去钙化，该装置公开在美国5,314,407号或6,818,001号专利中，其整个内容通过参考结合于此。该Rotablator装置(如下面所示)可以像最初描述的那样使用，或该远末端可以修改成平末端，在该末端上施以金刚石粉末，使该远末端更加球形等。见图58，该结构出自美国5,314,407号专利。
用于该Rotablator装置的空气涡轮可以用驱动某些或所有的前述的以机械为基础的治疗导管。该空气涡轮提供适当的转矩量和速度用于破坏小叶上的钙。该转矩和速度与该驱动轴的低惯性矩和本发明的远末端结合，减少灾难性的驱动轴故障的危险。例如，当该远末端由于与钙化沉积物接触而变成“加载的”时，旋转速度减小到零，而没有卡住或缠绕该驱动轴。作为对空气涡轮的一种替代，利用具有电子反馈系统的电机也是可能的，该电子反馈系统能够检测转矩和速度，使得电机在适当的时候可以减慢。
治疗导管的一些实施例可以包括围绕远端工作元件的可选的护套。如图54所示，该护套可以包括围绕远端工作元件的球形形状的远末端301。细长的近端部分连接于该球形远末端，并且尺寸和形状做成覆盖在该导管主体的内腔中的驱动轴的一些或全部。该球形形状的远末端可以包括允许提供介质(例如收缩介质、冷却液等)和/或用作波导的通道。机械元件或超声传递元件可以延伸超过该护套的末端。类似的叙述示于Nash的美国专利6,843,797号，其内容通过参考明确地结合于此。
在一些实施例中，该护套可以括吹灰器或允许该护套端部弯曲、延伸，和/或收缩的柔性部分。该护套通常不旋转，并且该护套的尺寸通常做成允许远端工作元件和驱动轴在该护套内旋转。远端工作元件在该护套内的旋转将铰接该护套(这取决于该驱动轴的致动的形状和类型)并且可以在钙化沉积物上产生“刮擦效果”。有利的是，该护套将传递该驱动轴的机械运动，同时通过控制该工作元件的振荡提供对小叶的保护层。护套可以用本领域熟知的各种材料制造并以这样的方式加强以便经受来自在球形远末端内的远端工作元件的摩擦。因此用于护套的一种有用的材料是钢，或编织的或其他导管加强技术。
在任何机械的实施例中，可以希望的是，循环或注入冷却流体可以减少被组织所感受的热能，并且在清除时帮助除去碎屑。通过在超声实施例或机械实施例中提供气蚀效应，这种流体可以帮助组织破碎。
利用微球和/或微气泡实现的去钙作用
如上所述。超声治疗导管和机械治疗导管的大多数包括延伸通过该导管主体到远端的内腔。有用的是，提供诸如冷却流体、超声收缩流体等的介质通过内腔到目标小叶，以放大对小叶上嵌入的钙化结节提供的能量的效果。在一个优选的结构中，该介质可以包括微球或微气泡。与本发明的方法和治疗导管一起使用的一种有用的收缩介质是OptionTM收缩剂(GE Healthcare)。利用气蚀效应和/或微气泡以增强治疗效果的各种方法的描述可以在Tachibana的美国专利USRE036939和Ben-Haim的美国专利6,321,109号中找到，其整个内容通过参考明确地结合于此。
通过包含微气泡的收缩介质提供的超声波能够增加气蚀效应和提供给小叶的破坏能量的量。在该操作中施加抽吸也能够增强破坏能量，如Cimino和Bond在下面一文中所描述的：“Physics of UltrasonicSurgery using Tissue Fragmentation：Part I and Part II”，Uitrasonic inMedicine and Biology，Vol.22，No.1，pp.89-100 and pp.101-117，1996。已经描述，具有超声脉冲的气体体(gas body)(例如微气泡)的相互作用增强非热扰动(例如与气蚀相关的机械现像)。因此，利用控制的具有微气泡的收缩剂的量可以增强对小叶钙化物的去除。利用具有超声能量的微气泡的更加全面的说明描述在Guzman等人的下面一文中：“Bioeffects Caused by Changing in Acuostic Cavitation Bubble Densityand Cell Concentration：A unified Explanation Based on Cell-to-BubbleRatio and Blast Radius，”Ultrasound in Med.& Biol.，Vol.29，No.8，pp.1211-1222，2003和Miller等人的文章：“Lysis and Sonoporation ofEpidermoid and Phagocytic Monolayer Cell by Diagnostic UltrasoundActivation of Contrast Agent Gas Bodies，”Ultrasound in Med.&Biol.，Vol.27，No.8，pp.1107-1113，2001，其整个内容通过参考结合于此。
但是，应当理解，微气泡的利用不限于超声和机械治疗导管。例如，如下面所示，收缩介质可以与RF导管或基于压电的导管一起使用。在RF导管中实施例中，该导管主体可以包括设置在靠近该导管远端的两个RF电极。具有微气泡的介质可以通过该导管的内腔提供给目标小叶，并且RF能量可以在两个导线之间输送以将能量提供给微气泡。在一些实施例中，可以希望的是，提供RF能量给小叶的钙化物而不用微气泡。在其他实施例中，可以希望的是，利用两者类型的能源以对小叶提供能量。
作为对RF电极的一种替换物，可以在该导管的远末端设置压电薄膜330(图60)。金属丝导线在该导管主体的内腔内(或外)延伸通过并且连接于发生器。如果金属丝导线设置在该导管主体的内腔内，该导管可以包括内管以使该导线绝缘。该介质可以通过该导管主体的内腔提供并且暴露于在该导管的远末端的压电薄膜，并且能量可以从该压电薄膜提供并进入具有微气泡的介质中。
保护
在本发明的另一方面，可以用保护装置和方法以收集并排空来自治疗区域的碎屑。在图61和62所示实施例中，过滤装置336设置在导引导管338的轴上。这种结构也可以在主动脉根部提供导引导管的固定，以对瓣膜提供稳定的进入系统或设置附加的治疗导管。
在另一个实施例中(图63)。过滤装置配置成以保护整个治疗区并且可以包括系统的过滤装置340，例如其中血液和吸出物从脉管系统的动脉一侧取出，过滤并且然后注回到静脉循环，更加详细的描述公开在Parodi的美国专利6,423,032号中，其内容通过参考明确地结合于此。抽吸口342在导管346的远末端围绕该超声探头344。
有利的是，使过滤装置施加成更加局部地靠近治疗部位(例如一次在一个小叶上)以保护局部结构，例如刚好位于在主动脉瓣上面的冠状动脉口。这样的过滤装置可以与诸如图64所示的超声抽吸导管的治疗装置一起使用，其中过滤装置350盖住在抽吸口354由超声探头352接合的单个的小叶。而且，过滤装置的形状可以优化为进入最相关的小叶或治疗部位，如图6所示。任何上述过滤装置或保护系统可以与这里所公开的任何治疗导管一起使用。
本发明的许多特征有助于最佳地将该治疗导管引导、定位和稳定在被治疗疾病的部位。除了导管和和导引装置特征之外，设置在瓣膜内的网篮、固定器或过滤结构，一些方法可以用于定位该导管。例如，心脏可以连接于起搏导线，并且然后心脏以增加的心率起搏，例如每分钟200次，于是其能够将主动脉小叶保持在比较固定的位置，同时抑制血流，并且使本发明的治疗导管能够施加于至少一个小叶。随着诸如抽吸外罩的导管的设置，起搏被停止，并且功能正常地保持小叶不被导管接合。在所有的小叶同时被接合的情况下，需要提供流通过该治疗导管，例如在灌注气囊或本领域已知的装置中，其某些特征示于Goldberg的美国4,909,252号专利中，其内容通过参考明确地结合于此。
成像
本发明的特征包括在操作之前、操作中和操作之后用于监测并成像的各种装置和方法。为此目的可以采用各种成像方式，包括心腔内超声(IEC)、经食道超声心动图(TEE)、荧光检查、血管内超声波(IVUS)、血管镜、从Sensant Inc./Seimens(San Leandro，CA)可得到的电容超声测量转换器，以及本领域熟知的其他装置。例如治疗导管可以具有一体形成在该外罩内或治疗元件轴上的成像装置，诸如相控阵血管内的超声元件。在一些实施例中，有利的是，将本发明的装置构造成使得它们的工作元件是单独的、，可拆卸的元件，这些元件与该护套是共轴的以使操作者能够取出工作元件并且在其位置放置成像元件。
在操作的各个阶段成像可能是关键性的，包括诊断疾病的类型和部位，放置治疗导管，评估该治疗方法以及在治疗之后验证该瓣膜的功能。成像装置可以局部地放置在治疗部位，例如在导管末端上，或导管主体上，靠着该治疗导管，或者在诸如本领域已知的更远的部位(例如，静脉腔、食道或右心房)。如果成像元件放置在治疗导管上，它适于“朝前看”，例如在治疗装置的前面在平面上成像或在多个平面成像。
采用询问法或其他成像方式也在本发明的范围内，例如用于看透血液以直接目测该治疗部位的红外成像，或弹性记录术，以检测什么类型的组织作为目标的组织运动的超声测量，例如，小叶组织或钙，或者检测钙化最厉害的瓣膜区。在本文中弹性记录术可以通过血管内超声(IVUS)导管，机械测量转换器或相控阵系统进行，例如在“Characterization of plaque components and vulnerability withintravascular ultrasound elastography”Phys.Med.Biol.45(2000)1456-1475一文中所描述的那些机械测量转换器或相控阵系统，其内容通过参考明确地结合于此。实践中，利用外部施加的力或者该组织区的“周期性刺激”的力，转换器可以移动到该瓣膜上的治疗部位，该刺激由外部力或该组织自身自然产生运动(例如瓣膜自身的打开和闭合)所引起的，可以采用初始基线读取。该基线可以通过该治疗的区域或小叶与本发明的抽吸导管(包括在治疗部位循环流体)接合来设置，通过该治疗导管插入超声转换器直到该治疗部位，并且用该超声转换器询问该目标区以建立该区域的弹性力学(应变/应力轮廓)。对于小叶的特定部位，然后可以停止灌注，在附加应力下用于该小叶(仅仅由抽吸)并且注意并评估在应变/应力轮廓中的位移以将治疗装置引导到显示较小弹性的部位(指示存在钙化沉积物的“较硬的”区)，见“Elastograpgy-移动开始”Phys.Med.Biol.45(2000)1409-1421和“Selected Methods for Imaging ElasticProperty of Biological Tissues Annu.Rev.Biomed.Eng.(2003)5；57-78”)，其内容通过参考明确地结合于此。
在一些例如具有超声或激光的例子中，也可以用于询问或成像该区域的同样的转换器或光纤也可以用于破碎或治疗在下面的钙化沉积物。一些参数可以被调节以将该治疗装置从诊断转换到治疗模式，这些参数包括频率、功率、总能量等。
此外，可以采用其他特征技术，用于对被治疗的钙化区定位目标或评估治疗结果，包括MRI、多普勒以及利用电阻数据、阻抗/电感反馈等的技术等。利用成像和诸如所描述的其他监测技术，能够得到更多的定目标的操作，其重点放在除去钙化沉积物以及限制对能够导致不想要的增殖响应的小叶和环的潜在组织损害。
治疗的能源/方法
在本发明预见的治疗导管中可以利用各种能量形式。特别是用于打碎或清除钙化沉积物的这些能量形式可以是超声能、激光能等。具体说，当在适当的范围操作时，一些Er:YAG激光可以具体地对钙定目标。正如在“Scanning electron microscopy and Fourier transformedinfrared spectroscopy analysis of bone removal using Er:YAG and CO2lasers”J Periodontol.2002Jun；73(6)：643-52，一文中看到的，定目标的骨清除的详细说明支持这一观点，该文的内容通过参考明确地结合于此。可选地，可以提供能量，以通过采用磨削激光(resurfacing laser)从该钙化沉积物周围或其上选择性地除去组织，该激光器选择性地将导致在控制的组织气化中含水组织定为目标，例如高能脉冲或扫描二氧化碳激光器、短脉冲的Er:YAG以及调制的(短和长脉冲的)Er:YAG系统。能量的施加可以用于进入血小板或分布在小叶之间的钙(松质)。实践中，希望除去覆盖钙沉积物的组织层，以便剩余的小叶的大部分是无损伤的并且不受不必要的热损害。而且，这种特别的组织破坏也可能被施加于除去该瓣膜环内的结痂的组织或肥大的区域，作为本发明治疗的一部分。
本发明的超声治疗导管可以在5至100kHz之间的范围内操作，其中振荡速率为10至200微米的范围内，例如75至150微米(最大移动在20至400微米之间)。此外，为了减小潜在的热损害或其他组织损害，有利的是，以脉冲方式操作该治疗装置，例如5-50％的负载循环，例如5-25％的负载循环，通过对大多数病变区域的能量的提供仔细地定目标，以减小对暴露于该能量下的组织的损害。
此外，有利的是，将治疗重点放在病变瓣膜的某些区域，其中除去或减少钙化沉积物，得到最大限度恢复的小叶可动性以及得到的瓣膜功能。例如，在该瓣膜环内，在小叶的最低点，在小叶的中部，或在该接缝处沉积物可以被初始定目标。将具有瓣膜的这些各种位置示意地示出在图66、67和68中，其中图67和68分别是沿着图66的A-A线和B-B线的剖视图。
根据所用能量的类型和频率，本发明的治疗导管不仅也可以用于除去钙该，而且用于除去或清除小叶本身，例如为移植最小限度发病的修复的瓣膜做准备，例如在Anderson的美国专利5,840,081和6,582,462号、Wilson的美国专利申请2004/0092858、Khairkhaha的WO2004/093728、Herman的WO2005/009285等中公开的那些，其内容通过参考明确地结合于此。利用本发明的装置的预先治疗可以方便这种修复的瓣膜的放置，因为从移植部位除去钙可以减少瓣膜周围的渗漏、移位，并且由于增大的有效瓣膜口，可以得到被移植的较大的修复。
移植装置
A.上述装置一旦修复完成之后被取出，作为对上述装置的一种替代或附属品，可以提供多种装置，该装置暂时或永久地植入在主动脉瓣上或其内。出现在下面的装置都是想要再狭窄被修复之后在体内保留至少一段时间，以便防止或延迟由于小叶的重新钙化、融合以及再狭窄引起该瓣膜变性。本发明在下环位置360或上环位置362的植入示于图67。
在一些实施例中，可以希望的是，放置诸如下面所述的线圈的植入，以延伸上环和下环，以对瓣膜提供附加的支撑并且在该瓣膜上提供较大的治疗区域。这个实施例的线圈的结构具有连接两个环部分的单个支杆，但是下部外形足够低，以便不阻塞刚好在该瓣膜环上方的冠状动脉。参考图68，由于其开口结构，该植入的上环部分可以在该冠状动脉上方延伸到该主动脉根部，用于附加的固定，见图69。
在另一个实施例中，该植入可以由金属丝、一系列金属丝，或类似于在周边支架或冠状支架中所用的蜂窝状结构形成。为了更好的设置在瓣膜环上，或瓣膜下面，有利的是，形成该植入环以使瓣膜的尖头处于正弦波的形式。此外，该植入环可以具有支杆，其延伸以安置靠在该瓣膜的环上，以提供一种结构或进一步在特定的瓣膜部位散布药物涂层。见图70、71和72。
在再一个实施例中，该植入可以由多个圈形成，例如三个相互成120度的圈。见图73-76。
在这个实施例和示出金属丝形式的其他实施例中，根据所希望的力，金属丝的直径为0.020″和0.250″之间。此外，金属丝可以是扁平的并且该结构可以包括在该圈之间的网状物，以提供较大的表面积，用于支撑该瓣膜或提供药剂。这种装置的圈可以以循环的方式朝着远端和近端移动，以进一步打开瓣膜小叶并且作为单独治疗破坏血小板。该装置于是如上所述可以永久地植入。可以希望的是，或者在瓣膜治疗之后，或者在永久植入以确保适当的放置时，取回该装置。取回的装置可以是用于布置该植入的供给导管，或者可以包括在修复导管的远末端上可膨胀的漏斗，或者可以包括任何数目的机械装置，该机械装置包括抓紧器或钩子，该钩子与该植入的上的钩子相配合，或者在某个位置抓紧该植入以便它可以被拉进该供给护套并且从该主体取出。
这里描述的植入的任何结构可以具有表面增强或涂覆以使得它们是射线透不过的，或者产生回声的，用于本领域熟知的操作评估的目的。正如冠状动脉支架植入术领域还熟知的，所述装置可以是永久性的，可取出的，或生物可侵蚀的。它们能够包含抗再狭窄剂或诸如上述提出的物质，以涂涂覆的形式，构造或施加在该装置的孔、积存处、孔隙或不规则的表面上。此外，该植入可以由某些抗钙化的材料构成，例如在美国专利6,254,635号中提出的那些抗钙化的材料，其内容通过参考明确地结合于此。而且本发明的植入可以构造成发出少量的电荷。由于该是带正电荷的，有利的是通过该主动脉植入的表面发出正电荷排斥钙。此外，电能可以由该植入供给以通过可植入的起搏器式的装置减小钙化，该装置如在美国专利6,505,080所公开的，其内容通过参考明确地结合于此。
而且，将某些机械操作与具有上述各种合适的药剂的植入相结合也属于本发明的范围。可以用于这种用途的抗再狭窄剂可以从本领域熟知的任何药剂或能量形式中选择。例如，诸如雷帕霉素、紫杉醇、西罗莫斯的药剂或其类似物，或氧化氮增强剂可以利用药物洗脱涂覆法涂覆在这些装置上，包含在潜在地形成的表面不规则性或特殊的表面特征中，例如孔或麻点(divot)。该装置可以构造成用于通过涂层或其他表面的结合以将药剂粘在执行本发明操作所用的该植入上来注入药物，，或者可以规定用于遵循本发明操作的口头管理。例如，根据本发明的治疗，可以规定病人一定剂量的他汀类药物、AEC抑制剂或通过介入提供延长瓣膜功能的其他药物。
图77-89表示用于用于急性的或亚慢性操作的系统的各种实施例。这些装置可以放置在主动脉瓣上并且扩张以再打开该主动脉瓣，并且然后保持在该位置一段时间，以便将该治疗的瓣膜暴露在抗再狭窄剂或构造成方便该修复和/或以防止再狭窄的能量形式下。示于图77和78的装置的特征是机械叶片400，其向外延伸以在接缝处接合并分开该融合的小叶。该叶片可以用任何合适的金属、塑料或组合制造，它们可以是自膨胀的(例如，由镍钛诺或埃尔基诺伊耐蚀游丝合金制造)，或它们可以用气动、液力、螺旋的或其他机械致动系统机械地致动的。该叶片可以是如上所示的可变形部件，或者每个叶片由几个连接在铰接部分的较刚性的部分构成，以允许该单元膨胀和收缩。该叶片可以构造成具有较窄边缘的长方形的横截面，其中该较窄的边缘构造成方便融合的小叶的分开，并配合在该接缝内而不影响该瓣膜的闭合能力。这些长方形叶片的较宽的面将接触该小叶的新分开的边缘。作为对长方形截面的一种替代，该叶片可以构造成具有更加翼形的或其他截面形状，以减小血流中的扰动，并减小对瓣膜小叶的伤害。
图79和80的装置示出用于根据本发明的方法的球囊系统。该球囊410的特征是具有用于注入抗再狭窄剂的多个孔412，这在下面更加详细地描述。这些孔可以足够小，只允许少量抗再狭窄剂注入，或者它们的尺寸做成允许较快的注入和供给较大体积的注入物。这些孔被设置成绕该球囊的四周均匀分布，或可以设置成与该接缝的位置更直接地对齐。
图81和82的装置包括其结合图77和78的特征和图79和80的特征的球囊系统。多个球囊放置成使得每个球囊与接缝424对齐。该装置的膨胀可以允许从心脏出来的血液连续的灌注并进入该装置放入其中的体内，这又使抗再狭窄剂的供给更加延长。图3的球囊上的孔类似于图79和80的装置上的孔的描述来设置。
用于这种用途的抗再狭窄剂可以从本领域所熟知的任何药剂系列和能量形式选择。例如，诸如雷帕霉素、紫杉醇、西罗莫斯的药剂或其类似物，或氧化氮增强剂可以利用药物洗脱涂覆法涂覆在本发明的任何装置上，包含在潜在地形成的表面不规则性或诸如孔或divots的表面特征。正如所述，通过在该装置的工作执行元件上，例如如图所示的球囊和连合部切开术叶片上，包含注入通道和注入孔，该装置可以被构造成用于注入药物。
能量提供可以通过多种不同的方式实现并用于不同的目的。射频能量可以通过对连合部切开术叶片供能被施加，或通过利用球囊上的孔隙以实现湿电极。微波、超声、高频超声能或脉冲电场(用于感应蜂窝式电穿孔)通过包含天线或电极被用于该叶片、球囊或支撑这些工作执行元件的导管轴。冷冻治疗可以利用循环诸如相变气体或液氮的冷却流体通过工作执行元件而实现。多种方式可以包含在单个装置中用于实现耐久的主动脉瓣修复的目标。
利用这种能量以方便瓣修复，例如通过使融合的小叶部分使容易分开。可选地，可以利用能量以延迟或防止治疗过的瓣膜再狭窄。利用能量供给防止再狭窄的一个例子是利用脉冲电场以感应蜂窝式脱落。本领域业已知道，纳秒级持续时间的电脉冲的应用能够改变细胞的细胞内组织和感应脱落，或计划的细胞死亡，这是是已经直到的临床证明的诸如紫杉醇或西罗莫斯的抗再狭窄药物作用机制的一个关键方面。
这些药剂和能量应用应当管理，同时病人在导管插入试验室经过几分钟到几小时的过程。可选地，该装置可以构造成允许病人返回具有该装置的医院层，，以便在几小时或几天的过程中能够进行药剂注入或能量施加。
B.作为对一旦修复完成并且抗再狭窄的药物的管理完成之后被取出的上述装置的一种替代或附属品，可以提供暂时或永久地植入该主动脉瓣上或其内的装置。出现在下面的装置都是想要再狭窄被修复完成之后在体内保留至少一段时间，以便防止或延迟该瓣膜重新相互粘在一起并发生再狭窄。
该装置可以是永久的，可取出的，或生物可侵蚀的。它们能够包含构造在或施加在该装置的涂层、孔、积存处、孔隙或表面不规则性中的抗再狭窄剂或物质。
支杆430以用任何合适的金属、塑料或组合制造，如图83和84所示。在植入期间它们可以是自膨胀的(例如，由镍钛诺或埃尔基诺伊耐蚀游丝合金制造)，或它们可以用气动、液力、螺旋的或其他机械致动系统机械地致动，并且然后，在从供给系统布置在该装置中之前，锁定成它们的最终位置。该支杆可以是如上所示的可变形部件，或者每个支杆由几个连接在铰接部分的较刚性的部分构成，以允许该单元膨胀和收缩。该支杆可以构造成具有较窄边缘的长方形形状的横截面，其中该较窄的边缘构造成方便分开融合的小叶，并配合在该接缝内而不影响该瓣膜的闭合能力。这些长方形支杆的较宽的面将接触该小叶的新分开的边缘。作为对长方形截面的一种替代，该支杆可以构造成具有比较翼形形状的或其他截面形状，以减小血流中的扰动，并减小对瓣膜小叶的伤害。
图85-89示出用于可植入装置的另一种结构。应当指出，对修复过的小叶的治疗区实现提供长期抗再狭窄剂或能量形式的该植入的任何结构应当认为是本发明的主题。位于在该主动脉壁上并且通常与该支杆连续的固定元件(如图83和84所示)，其在与该支杆重新组合之前连接在该主动脉的中心(如图85和86所示)，或者该支杆本身是固定元件的结构(如图87-89所示)都是本发明的实施例。
可植入并生物可侵蚀的装置的特征是诸如雷帕霉素、紫杉醇、西罗莫斯的药剂或其类似物，或氧化氮增强剂，其可以利用药物洗脱涂覆法涂覆在本发明的任何装置上，或包含在潜在形成的表面不规则性或诸如孔或divots的特殊表面特征上。
除了作为供给系统特征包含再该植入中的这些药剂之外，附加的抗再狭窄剂或能量形式可以分开提供。
虽然本发明对各种修改和可选形式是敏感的，其具体例子已经示于附图中并且在此进行了详细描述。但是应当理解，本发明不限于所公开的具体形式或方法，而是相反，本发明含盖属于本发明和权利要求精神和范围内的所有修改、等同物以及替代方案。

Claims (33)

1.一种用于贲门瓣修复的治疗导管，包括：
包括近端和远端的导管主体；
靠近该导管主体的远端的装置，用于在该贲门瓣上或其附近的局部钙化部位形成栓塞容纳区；以及
适于破坏该钙化部位的工作元件，所述工作元件能够设置在栓塞容纳区。
2.如权利要求1所述的治疗导管，其中该工作元件包括能量输送元件，例如超声元件，其在选择成在该钙化部位破坏钙化沉积物的条件下输送能量。
3.如权利要求1所述的治疗导管，其中该导管主体是可操纵的或者是可定位的，以使使用者能够朝着该钙化的部位引导该远端。
4.如权利要求1所述的治疗导管，还包括在该导管主体上的定位结构，用于定位和/或稳定靠近该钙化部位的该工作元件。
5.如权利要求1所述的治疗导管，其中该栓塞容纳形成装置包括成形的球囊、网篮或过滤器。
6.如权利要求5所述的治疗导管，其中该栓塞容纳装置包括设置在该治疗导管上的过滤器、与吸出装置相连的灌注球囊、抽吸导管、在该治疗部位或者在该治疗部位下游的单独的过滤装置，或者外部过滤器和灌注系统。
7.如权利要求6所述的治疗导管，其中该保护装置包括过滤器，该过滤器的形状做成使该治疗导管能够进入被治疗的位置，同时仍然允许通过该病变的主动脉瓣的流体流。
8.如权利要求1所述的治疗导管，包括保护装置，该保护装置收集和/或排空来自该病变的主动脉瓣周围的治疗部位的碎屑。
9.如权利要求1所述的治疗导管，还包括成像组件。
10.如权利要求9所述的治疗导管，其中该成像元件包括心腔内超声(IEC)组件、经食道超声心动图(TEE)组件、血管内超声组件、血管镜组件。
11.一种系统，包括如权利要求1至10中任何一项所述的治疗导管，还包括导引导管，该导引导管包括构造成接纳该治疗导管的内腔。
12.如权利要求11所述的系统，还包括辅助定位导管，该辅助定位导管能够定位在该导引导管的内腔内并围绕该治疗导管。
13.如权利要求1所述的治疗导管，其中该工作元件包括RF电极。
14.如权利要求1所述的治疗导管，其中该工作元件包括可旋转的末端。
15.如权利要求14所述的治疗导管，其中该可旋转的末端包括线圈。
16.如权利要求14所述的治疗导管，其中该可旋转的末端包括叶轮。
17.如权利要求14所述的治疗导管，其中该可旋转的末端包括磨削器。
18.如权利要求14所述的治疗导管，包括护套，该护套设置在该可旋转的末端上。
19.如权利要求1所述的治疗导管，其中该导管主体的远端包括抽吸外罩。
20.一种的血管内的植入物，用于放置在瓣膜环、上环、下环或其组合内以帮助维持功能性的瓣膜口，该血管内的植入包括至少一个材料线圈或材料环。
21.如权利要求20所述的血管内的植入物，其中该线圈或环包括包括药剂，以通过减少再狭窄而增加功效，并且还有助于瓣膜功能。
22.如权利要求20所述的血管内的植入物，其中该血管内的植入物经由逆行方式从股动脉引入，进入主动脉，并且从上升动脉穿过该瓣膜，或者通过顺行方式一一横膈的，穿过二尖瓣，通过左心房并且穿过该主动脉瓣。
23.如权利要求20所述的血管内的植入物，其中该至少一个材料线圈或材料环包括由单个支杆连接的上瓣膜状环和下环孔。
24.如权利要求20所述的血管内的植入物，其中该至少一个材料线圈或材料环包括一个和多个正弦波形的环。
25.如权利要求24所述的血管内的植入物，包括一个和多个支杆，该一个和多个支杆延伸以安置在该主动脉瓣的环上，以提供一种结构或将药物涂层进一步散布于该主动脉瓣。
26.如权利要求20所述的血管内的植入物，其中该至少一个材料线圈包括多个圈。
27.如权利要求26所述的血管内的植入物，其中该多个圈包括设置成相互成120度角的三个圈。
28.一种治疗具有一个或多个钙化部位的贲门瓣的的方法，所述方法包括：
在该钙化部位上形成栓塞容纳区；以及
给该钙化部位供给能量，以破坏所述部位并且潜在地形成包含在所述容纳区的栓塞。
29.如权利要求28所述的方法，还包括从该容纳区除去栓塞。
30.如权利要求28或29所述的方法，其中形成该栓塞容纳区包括在该区设置一种结构，其中该结构不跨过相关的血管。
31.如权利要求30所述的方法，其中该结构包括外罩、球囊、网篮或过滤器。
32.如权利要求28或29所述的方法，其中形成该栓塞容纳区包括从围绕该钙化部位的区域吸出栓塞，而不是放置一种结构。
33.如权利要求28至32中任何一项所述的方法，其中所述能量是超声波、射频、微波、机械能或冷冻能。
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US11272982B2 (en) 2022-03-15
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US10350004B2 (en) 2019-07-16
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WO2006063199A2 (en) 2006-06-15
US20190350651A1 (en) 2019-11-21
WO2006063199A3 (en) 2007-07-19
EP1819304A2 (en) 2007-08-22
CN101076290B (zh) 2011-11-23
US7803168B2 (en) 2010-09-28
US20100324554A1 (en) 2010-12-23
US20060229659A1 (en) 2006-10-12
US20170014183A1 (en) 2017-01-19
JP2008522755A (ja) 2008-07-03
US20130345715A1 (en) 2013-12-26

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