CN104582597B - 具有多个冲击波源的冲击波球囊导管 - Google Patents

具有多个冲击波源的冲击波球囊导管 Download PDF

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CN104582597B
CN104582597B CN201380033808.3A CN201380033808A CN104582597B CN 104582597 B CN104582597 B CN 104582597B CN 201380033808 A CN201380033808 A CN 201380033808A CN 104582597 B CN104582597 B CN 104582597B
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sacculus
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CN104582597A (zh
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J·M·亚当斯
T·G·戈夫
D·哈卡拉
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Abstract

本发明涉及一种设备，该设备包括适于安置在身体的钙化区域附近的球囊。该球囊可利用液体充胀。该设备还包括位于球囊内、产生经液体传播以撞击球囊附近的钙化区域的冲击波的冲击波发生器。该冲击波发生器包括分布在所述球囊内的多个冲击波源。

Description

具有多个冲击波源的冲击波球囊导管
相关申请的交叉引用
本申请要求于2012年6月27日提交的美国专利申请No.13/534,658的优先权，该申请的全部内容在此通过引用并入。
背景技术
主动脉钙化，也称为主动脉硬化，是钙沉淀物在心脏中的主动脉瓣膜上的累积。这常常会导致心杂音，该心杂音能够容易地用放在心脏上方的听诊器听到。然而，主动脉钙化通常并不明显地影响主动脉瓣膜的功能。
然而，在一些情况下，钙沉淀物变厚并且使得在主动脉瓣膜的开口变窄。这减少了通过所述瓣膜的血流量，引起胸痛或心脏病发作。医生将这种狭窄称为主动脉狭窄。
主动脉钙化通常会影响老年人。但当它发生在年轻人身上时，其常常与先天性(天生的)的主动脉瓣膜缺陷或与诸如肾衰竭的其他疾病有关。对心脏的超声(超声心动图)能够确定主动脉钙化的严重性并且还检查其他可能引起心杂音的原因。
当前，对主动脉钙化没有特定的治疗。一般治疗包括监测心脏病的进一步发展。还检查胆固醇水平，以确定需要药物治疗来降低胆固醇而希望阻止主动脉钙化的恶化。如果瓣膜严重变窄，则主动脉瓣膜置换手术可能是必需的。
可用球囊导管将主动脉瓣膜区域打开或扩大(球囊瓣膜成形术)，该球囊导管以与心导管插入术中极为相同的方式引入。利用球囊瓣膜成形术，主动脉瓣膜区域通常轻微地增大。因此患有严重主动脉狭窄的患者通过这种治疗能够体验到临时好转。不幸的是，这些瓣膜中的大部分在6-18个月的时间后变窄。因此，球囊瓣膜成形术作为临时缓解不是主动脉瓣膜置换的候选人的患者的症状的短期措施是有用的。
需要紧急非心源性手术的患者，诸如需要髋关节置换术的患者，可在手术前从主动脉瓣膜成形术中受益。瓣膜成形术改善了心脏功能并提高了非心源性手术的存活机会。主动脉瓣膜瓣膜成形术还可用作为心室肌功能较差的老年患者中的主动脉瓣膜置换的桥接器。球囊瓣膜成形术可临时改善心室肌功能，并且因此提高手术存活率。那些对于瓣膜成形术表现出心肌功能改善的人能够期望从主动脉瓣膜置换中获益更多。在这些高风险的老年患者中的主动脉瓣膜成形术与手术候选人中的主动脉瓣膜置换具有相似的死亡率(5％)以及严重的并发症率(5％)。
经动脉主动脉瓣膜置换是一种用自扩张镍钛诺或球囊扩张瓣膜结构置换主动脉瓣膜的新颖手术。此类手术利用光滑的未钙化圆周来附装新瓣膜。大的钙沉淀物可能引起瓣膜周围的泄漏而阻碍瓣膜在主动脉上的牢固、稳定的附装。因此，需要无钙瓣膜床来附装这种自扩张瓣膜。
题为“冲击波瓣膜成形术系统(SHOCKWAVE VALVULOPLASTY SYSTEM)”、于2009年11月11日提交的、共同未决的美国申请系列号No.12/611,997中公开和保护了一种用于治疗狭窄或钙化的主动脉瓣膜的替代方法和系统。如其中所述，球囊被放置在待治疗的瓣膜的的瓣叶附近并且可用液体充胀。球囊内设置有产生经液体传播并撞击在瓣膜上的冲击波的冲击波发生器。撞击冲击波软化、破碎和/或松动待被除去或移位的钙化区域，以打开瓣膜或扩大瓣膜开口。
上述方法提供了比预先执行的主动脉瓣膜置换更容易接受的对主动脉狭窄和钙化的主动脉瓣膜的治疗。它也是比当前的瓣膜成形术治疗更有效的治疗。对于接受经主动脉或基于导管的主动脉瓣膜置换的患者而言，该新颖的方法可以比当前瓣膜成形术更有效地软化、平顺和打开主动脉瓣膜环并准备用于导管传送的瓣膜的区域。
在上述冲击波瓣膜成形术中，冲击波的撞击强度随着从冲击波源点到瓣膜的距离而削弱。更具体地，冲击波的撞击强度与从冲击波源点到瓣膜的距离的平方成反比。因此，当施加冲击波时，期望此时通过能使冲击波源与被治疗的瓣膜部位之间的距离最小化来使冲击波的效力最大化。
血管成形术存在类似问题。其中，静脉或动脉的钙化区域可扩展到静脉或动脉的一定纵向距离上。这种情况下，血管成形术球囊内的点冲击波源将由于从冲击波源到钙化区域的各个部分的不同距离而不会在钙化区域的范围内一致地有效。
本发明通过提供可能的最有效的瓣膜成形术和血管成形术治疗而解决了该问题和其它重要问题。
发明内容
在一个实施例中，一种设备包括适合安置在身体的钙化区域附近的球囊。该球囊可用液体充胀。该设备还包括位于球囊内的冲击波发生器，该冲击波发生器产生经液体传播以冲撞球囊附近的钙化区域的冲击波。冲击波发生器包括分布在球囊内的多个冲击波源，其中所述多个冲击波源包括多于两个的冲击波源。这些冲击波源既可以纵向地又可以周向地分布在球囊内以达到最佳效果。
球囊是沿其长度具有纵向尺寸的长形球囊，并且多个冲击波源沿纵向尺寸的一部分延伸。球囊具有侧壁，并且冲击波源与球囊侧壁成非接触关系。冲击波发生器可以是电弧冲击波发生器，并且冲击波源可包括多个电极。电弧冲击波发生器还可包括适合与液体接触并接收极性与施加至多个电极的电压极性相反的电压的至少一个反电极。
冲击波发生器可包括长形导体和覆盖该长形导体的绝缘体。该绝缘体可具有多个离散开口，每个开口都用于将长形导体暴露于流体，以形成多个电极。可采用绝缘线来形成长形导体和覆盖的绝缘体。
该设备还可包括长形载体。该载体可穿过球囊延伸并密封于该球囊上。绝缘线可环绕位于球囊内的载体缠绕。载体可包括导引线内腔。绝缘线可环绕载体缠绕以形成电极线圈匝，并且所述设备还可包括环绕位于球囊内的载体缠绕且位于电极线圈匝之间以形成反电极的导体线。
冲击波发生器可包括长圆柱形导体和覆盖该长圆柱形导体的绝缘体。该绝缘体可具有多个离散开口，每个开口都用于将长圆柱形导体暴露于流体，以形成多个电极。所述设备还可包括穿过球囊延伸并与该球囊成密封关系的长形载体。长圆柱形导体可覆盖位于球囊内的载体。长形载体可包括导引线内腔。
冲击波发生器可以是电弧冲击波发生器，其中冲击波源包括多个电极，其中所述设备还包括具有纵向尺寸、穿过球囊延伸并与该球囊成密封关系的长形载体，其中长形载体具有沿长形载体的纵向尺寸的至少一部分延伸的导引线内腔，并且多个电极中的至少一些电极在球囊内沿长形载体分布。
长形载体可由绝缘材料形成。冲击波发生器可包括与导引线内腔成间隔开的关系并沿长形载体的纵向尺寸的至少一部分在长形载体内延伸的至少一个导体，并且长形载体绝缘材料的多个离散部分被除去以露出至少一个导体的多个对应部分，从而形成多个电极中的至少一些电极。长形载体绝缘材料的被除去的离散部分中的至少一些部分可包含导电填料。导电填料可导电地固定在长形导体上。
长形载体可由绝缘材料形成。冲击波发生器可包括彼此间隔开且与导引线内腔成间隔开的关系并在长形载体内沿长形载体的纵向尺寸的至少一部分延伸的至少第一和第二长形导体。长形载体绝缘材料的多个离散部分可被除去以露出所述至少第一和第二导体的多个对应部分，从而形成多个电极中的至少一些电极。
长形载体绝缘材料的露出所述至少第一和第二导体中的一者的多个对应部分的被除去的离散部分的尺寸大于长形载体绝缘材料的露出所述至少第一和第二导体中的另一者的多个对应部分的被除去的离散部分。长形载体绝缘材料的至少一些被除去的离散部分可包含导电填料，并且至少一些导电填料可导电地固定在长形导体上。
多个电极成串联电路关系布置。替代地，多个电极成并联电路关系布置。所述设备还可包括电源和选择性地使多个电极一次一个地与所述电源联接的多路选择器。在另一实施例中，多个电极可以多个串联电路布置结构布置，并且所述设备还可包括选择性地使所述串联回路布置结构一次一个地与所述电源联接的多路选择器。
多个冲击波源可沿限定出环路的路径布置。球囊可构造成安置在瓣膜的相邻的瓣叶附近，球囊具有与瓣叶的一侧相邻的第一腔室和与瓣叶的对向侧相邻的第二腔室。多个冲击波源可布置成在球囊的第一和第二腔室中的一者内限定出冲击波源的环路。
球囊可构造成安置在瓣膜的瓣叶附近，球囊具有与瓣叶的一侧相邻的第一腔室和与瓣叶的对向侧相邻的第二腔室，并且多个冲击波源可布置成限定出位于球囊的第一腔室内的冲击波源的第一环路和位于球囊的第二腔室内的冲击波源的第二环路。
根据另一实施例，一种设备包括长形载体和与其成密封关系地承载在该长形载体上的球囊。球囊适合安置在身体的钙化区域附近并且可用液体充胀。该设备还包括位于球囊内的电弧冲击波发生器。电弧冲击波发生器包括分布在球囊内的多于两个的电极。各电极适合产生经液体传播以冲撞球囊附近的钙化区域的冲击波。该设备还包括适合与液体接触并接收与施加至所述多于两个的电极的电压极性相反的电压极性的反电极。
在又一实施例中，一种方法包括以下步骤：将球囊插入体内使该球囊位于钙化区域附近，用液体充胀球囊以使球囊与钙化区域接触，将包括多于两个的冲击波源的冲击波发生器安置在球囊内，并且将所述多于两个的冲击波源分布在球囊内，以及使冲击波源形成经液体传播并冲撞钙化区域的冲击波。
插入步骤可包括将球囊插入身体的动脉或静脉内。球囊可以是具有纵向尺寸的长形球囊，并且分布步骤可包括沿所述纵向尺寸的一部分分布冲击波源。
插入步骤可包括将球囊插入身体的瓣膜内。分布步骤可包括沿限定出环路的路径分布冲击波源。
球囊可构造成安置在瓣膜的相邻的瓣叶附近并且具有适合与瓣叶的一侧相邻的第一腔室和适合与瓣叶的对向侧相邻的第二腔室。插入步骤可包括在第一腔室与瓣叶的一侧相邻并且第二腔室与瓣叶的对向侧相邻的情况下将球囊插入瓣膜中。分布步骤可包括沿限定出冲击波源的环路的路径将冲击波源分布在球囊的第一和第二腔室中的一者内。
在又一实施例中，球囊构造成安置在瓣膜的瓣叶附近，其中球囊具有与瓣叶的一侧相邻的第一腔室和与瓣叶的对向侧相邻的第二腔室，其中插入步骤包括在第一腔室与瓣叶的一侧相邻并且第二腔室与瓣叶的对向侧相邻的情况下将球囊插入瓣膜中，并且分布步骤包括将冲击波源分布成在球囊的第一腔室内限定出冲击波源的第一环路并在球囊的第二腔室内限定出冲击波源的第二环路。
球囊具有侧壁，并且所述分布步骤可包括与球囊侧壁成非接触关系分布冲击波源。冲击波发生器可以是电弧冲击波发生器，冲击波源可包括多个电极，并且所述使冲击波源形成经液体传播并冲撞钙化区域的冲击波的步骤可包括在反电极与多个电极之间施加电压脉冲以形成冲击波。
根据又一实施例，一种方法包括：将球囊插入体内使该球囊位于钙化区域附近；用液体充胀球囊以使球囊与钙化区域接触；将多于两个的电极以与球囊成非接触关系并邻近钙化区域地安置在球囊内；以与液体接触的方式安置反电极；以及在反电极与多于两个的电极之间施加电压脉冲，其中电压脉冲具有施加至所述两个或多于两个的电极的第一极性和施加至所述反电极的第二极性，从而使得所述多于两个的电极形成经液体传播并冲撞钙化区域的冲击波。
附图说明
在所附权利要求中特别地阐明了相信是新颖的本发明的特征。通过结合附图并参考下面的描述，可最佳地理解本发明的各种实施例及其代表性的特征及优势，在一些图中，相似的附图标记表示相同的元件，其中：
图1是根据一个实施例的体现本发明的血管成形术系统的简图，包括扩张血管成形术球囊导管的侧视图，所述导管包括多个冲击波源；
图2是图1的导管的侧视图，示出了可用在图1的扩张血管成形术球囊导管内的替代电极结构；
图3是图1的导管的侧视图，示出可用在图1的扩张血管成形术球囊导管内的又一替代电极结构；
图4是示出用以提供多个冲击波源的图3的电极结构的替换方案的局部剖视图；
图5是根据本发明又一实施例的包括多个冲击波源的另一扩张血管成形术球囊导管的侧视图；
图6是示出根据本发明一实施例的图5的导管的电极结构可制造成提供多个冲击波源的方式的透视图；
图7是示出根据本发明一实施例的图5的电极结构的另一方案的另一透视图；
图8是体现本发明的冲击波血管成形术系统的简化示意图，其中冲击波源电极布置在并联电路中；
图9是心脏的左心室、主动脉和主动脉瓣膜的简化侧视图，其中体现本发明的瓣膜成形术治疗导管位于心脏的主动脉瓣膜内；
图10是用于图9的瓣膜成形术导管内的电极结构的扩大了比例的透视图；
图11是心脏的左心室、主动脉和主动脉瓣膜的另一简化侧视图，其中体现本发明的双腔室瓣膜成形术治疗导管位于心脏的主动脉瓣膜内；
图12是具有可用于本发明实施例中的电极结构的血管成形术导管的扩大了比例的局部侧视图，其中电极布置在串联电路中；
图13是体现本发明的冲击波血管成形术系统的简化示意图，其中冲击波源电极布置在串联电路中；
图14是体现本发明的冲击波血管成形术系统的简化示意图，其中冲击波源电极布置在多个串联电路中，各串联电路单独启用；
图15是根据另一实施例的体现本发明的另一血管成形术系统的简图，包括扩张血管成形术球囊导管的侧视图，所述导管包括可选择性地一次一个地与电源联接的多个冲击波源；以及
图16是示出图15的电极可选择性地与电源联接的方式的时间图。
具体实施方式
图1示出根据本发明一个实施例的体现本发明的血管成形术系统10，该血管成形术系统包括扩张血管成形术球囊导管20，该导管包括多个冲击波源。导管20包括长形载体21和在密封件23处与载体21成密封关系地环绕载体21形成的扩张球囊26。球囊26环绕载体21形成环形通道27，该环形通道可供诸如盐水之类的流体进入球囊以使球囊充胀。载体21包括导引线内腔29。导引线内腔布置成接纳导引线，所述导引线可用来将导管引导到期望位置以将球囊定位在动脉或静脉的要治疗的区域附近。
电极结构40由载体21承载。电极结构40包括卷绕在载体21周围的绝缘线42。绝缘线42的绝缘体内有多个开口44，所述多个开口使绝缘线导体的相应离散部分暴露于球囊内的盐水。各开口44形成对应的冲击波源或电极46。如在图1中可见的，多于两个的多个电极以此方式并与球囊26的侧壁成非接触关系地形成。
电极结构40还包括反电极24。反电极24设置成与球囊26的侧壁成非接触关系，并且用作公共电极以在电极46与反电极24之间施加适当的高电压时引起电极46中的每一者与公共电极24之间出现电弧。
为此，电极24和46经连接器32附接至高压脉冲源30。电极24和46由诸如不锈钢或钨之类的金属形成并且安置成隔开受控的距离，以允许针对给定电压和电流的可再现的电弧。流体中的电极24和电极46之间的电弧用来在流体中产生冲击波。可变高电压脉冲发生器30用于横跨电极24和电极46传送脉冲流，以在球囊26内且沿着该球囊的纵向长度25以及在被治疗的动脉(未示出)内形成冲击波流。可以通过控制脉冲电压、电流、持续时间和重复率的大小来控制冲击波的大小。球囊26的绝缘性质保护患者免遭受电休克。
球囊26可充填有水或盐水以与钙化病变区紧邻地将球囊轻轻固定在动脉的壁内。流体还可包含x射线对比剂以容许在使用期间用荧光镜观察导管。如上所述，载体21包括可供导引线(未示出)插入以将导管引导到位的内腔29。一旦通过利用导引线(未示出)和导引线内腔29定位导管，医生或手术施行者便可以低能量冲击波开始并按需增加能量以使钙化斑破裂。此类冲击波将经流体、球囊、血液和脉管壁传导到钙化病变区，在此能量将在球囊不对动脉壁施加过大压力的情况下使硬化斑破碎。
产生电弧所需的电压将取决于电极之间的间隙并且通常为100至3000伏。脉冲持续时间还将取决于电极24和46的表面积并且需要足以在电极的表面产生气泡以使得电流的等离子体电弧跳过每个气泡，并且在每次发生时形成快速膨胀和塌缩的气泡，这在球囊中形成机械冲击波。这种冲击波可以短至几毫秒。气泡的快速膨胀和塌缩两者都形成冲击波。可以调节脉冲持续时间以使一者优于另一者。大蒸汽气泡将产生比小蒸汽气泡强的冲击波。然而，系统中需要更多动力来产生这种大的蒸汽气泡。传统超声波碎石机尝试产生大蒸汽气泡以使塌缩气泡的冲击波最大化。在球囊内，由于球囊破裂的风险而不希望产生这种大的蒸汽气泡。通过将脉冲宽度调节为小于两毫秒或甚至小于一毫秒的窄脉冲，可以产生快速膨胀的蒸汽气泡和冲击波，同时可以使蒸汽气泡的最终尺寸最小化。短脉冲宽度还减少了球囊中的发热量以提高组织安全性。
图2示出可用于图1的导管20中的另一电极结构140。与图1的电极结构一样，图2的电极结构140包括环绕载体21卷绕以形成(多个)电极线圈匝144的绝缘线142。绝缘线142的绝缘体内有多个开口146，这些开口使绝缘线导体的相应离散部分暴露于球囊内的盐水。各开口146形成对应的冲击波源或电极148。
电极结构140还包括缠绕在位于球囊26内的载体21周围的导体线。导体线150卷绕在各电极线圈匝144之间以形成反电极152。这提供了电极148与反电极152之间更均匀的间距。所有电极148和152都设置成与球囊26的侧壁成非接触关系。
图3示出可用于图1的导管20中的另一电极结构240。这里，导管20的电极结构240包括覆盖载体21的、由诸如不锈钢或钨之类的金属形成的长圆柱形导体242。电极结构240还包括覆盖长圆柱形导体242的绝缘体244。绝缘体244具有使长圆柱形导体的相应区域暴露于球囊26内的盐水的多个离散开口246。各开口246形成对应的电极248。另一电极250形成公共电极。所有电极248和250都设置成与球囊26的侧壁成非接触关系。
图4是示出了图3的电极结构240的替换方案的局部剖视图，其用于提供多个冲击波源。这里，至少一些开口246充填有导电材料以形成电极249。形成电极249的导电填料可以是与形成导电圆柱体242的材料相同的材料或者可以是不同的导电材料。所述导电填料用于使电极的表面隆起到绝缘体244之上，在一些情况下，这可引起更可靠的电弧形成。
现在参照图5，图5是根据本发明又一实施例的包括多个冲击波源的另一扩张血管成形术球囊导管320的侧视图。同样，导管320包括长形载体321和在该长形载体远端与该长形载体成密封关系的血管成形术扩张球囊326。球囊326和载体321形成可供充填诸如水和盐水之类的液体的通道327。载体321还包括适合接纳导引线330的导引线内腔329。
导管320还包括电极结构340，该电极结构包括多个第一电极332和多个第二电极342。电极332和342设置成与球囊326的侧壁成非接触关系。在血管成形术治疗期间，具有第一极性的电压施加至多个第一电极332，且具有反极性的电压施加至多个第二电极342。如果如上所述在全部电极332和342上施加电压，则将在对应的电极对332和342之间形成电弧以产生对应的冲击波。这样，沿球囊326的纵向尺寸产生冲击波。
在图5中可见，电极332的尺寸比电极342大并且与球囊中的盐水接触的表面积比电极342大。这减小了对电弧等离子形成的阻碍，从而允许在向电极施加电压之后不久即产生电弧等离子体。还已发现这使得形成更大的电弧等离子体，从而产生更强的冲击波。其还辅助控制其上将产生电弧的电极。
图6是示出根据本发明实施例的图5的导管的电极结构可制造成提供多个冲击波源的方式的透视图。在图6中可见，电极结构340包括第一导体344和第二导体346。导体344和346在载体321内沿该载体321延伸。可通过在载体321的制造期间使导体344和346与长形载体共挤出而将导体344和346制造成在载体321内沿该载体321延伸。在挤出过程之后，开口348和350可形成在载体321中以露出导体344和346的相应部分。这使得分别形成了电极332和342。图7示出可用导电填料充填诸如形成在载体321中的开口350之类的开口以形成电极342。
图8是体现本发明的冲击波血管成形术系统410的简化示意图，其中冲击波源电极布置在并联电路中。出于本说明书的目的，图5的导管320应当是为了说明而使用的。该系统包括高电压发生器430、连接器432和导管320。导管320包括多个第一电极332和多个第二电极342。多个第一电极32中的每一个电极与多个第二电极342中的相应电极一一对应。连接器422将多个第一电极332中的各电极经电阻R与电压发生器430的正(+)侧连接，并且将多个第二电极342中的各电极与电压发生器430的负(-)侧连接。电阻R可以通过单独的电阻元件或通过将电极与连接器连接并且为了使各电极对可用的电流相等而设置的导体中的电阻率提供。这保证了没有一个电极对会衰减可获得的全部电流而妨碍所有其它电极对产生电弧。
图9是心脏的左心室500、主动脉502和主动脉瓣膜504的简化侧视图，其中体现本发明的瓣膜成形术治疗导管510位于心脏的主动脉瓣膜内。导管510包括安置在主动脉瓣膜瓣叶506的两侧的治疗球囊526。心脏的瓣膜例如主动脉瓣膜504可能变狭窄并钙化。更具体地，由瓣叶限定的瓣膜的开口可能变狭窄并钙化。这会限制开口的尺寸，因为瓣膜瓣叶506由于钙沉淀物和纤维化组织而增厚。增厚的瓣叶506和更小的瓣膜开口限制血液从心脏流出，从而导致心脏过度工作和不良的心排血量。当前治疗包括瓣膜的置换或尝试用球囊扩开瓣膜环。
治疗球囊526包括安置在主动脉瓣膜瓣叶506的对向两侧的两个沿纵向隔开的腔室528和530。球囊526可由顺应或非顺应材料形成。球囊位于载体521的远端处。导管通过长形输送管532放置到位。
两个沿纵向隔开的腔室530和528共享载体521的公共充胀内腔534，以容许使用诸如盐水之类的液体充填球囊526。或者，球囊腔室530和528可以不共享同一充胀流体路径。
导管510包括在球囊内产生电弧以在围住的液体内产生冲击波的多个冲击波源。冲击波经液体传播并冲撞球囊壁和瓣膜。冲撞冲击波使得瓣膜上的钙化材料破碎和/或软化。这容许瓣膜开口变宽或除去钙化材料。
根据图9的实施例，导管510包括位于球囊腔室528内的电极结构540。电极结构540可在图10中更详细地看到。电极结构总体包括公共电极或反电极544和分布在限定出环路的路径中的多个电极542。所述多个电极可以上述方式利用绝缘导体——例如绝缘线——形成，其中绝缘体的离散部分被除去以形成电极。各电极542形成冲击波源。如在图9中可见，电极542布置成与球囊526的侧壁成非接触关系。
在使用中，电弧形成电压的一个极性例如正极极性可施加至多个电极542。负极极性可施加至反电极544。由于电极542沿如图所示的环路分布，所以电极与瓣膜之间的间距将保持基本恒定以使得能够在不削弱冲击波强度的情况下治疗整个主动脉瓣膜。
图11是心脏的左心室500、主动脉502和主动脉瓣膜504的另一简化侧视图，其中体现本发明的另一瓣膜成形术治疗导管610位于心脏的主动脉瓣膜内。导管610包括安置在主动脉瓣膜瓣叶506的两侧的治疗球囊626。治疗球囊626包括安置在主动脉瓣膜瓣叶506的对向两侧的两个沿纵向隔开的腔室628和630。球囊626可由顺应或非顺应材料形成。球囊位于载体621的远端处。导管通过长形输送管632放置到位。
两个沿纵向隔开的腔室630和628共享载体621的公共充胀内腔634以容许使用诸如盐水之类的液体充填球囊626。或者，球囊腔室630和628可以不共享同一充胀流体流经。
导管610的各球囊腔室628和630包括在球囊各自的腔室内产生电弧以在围住的液体内产生冲击波的多个冲击波源。冲击波经液体传播并冲撞球囊壁和瓣膜。冲撞的冲击波使得瓣膜上的钙化材料破碎和/或软化。这容许瓣膜开口变宽或除去钙化材料。
根据图11的实施例，导管610包括分别位于球囊腔室628和630内的电极结构640A和640B。电极结构可呈如图10所示的电极结构540的形式。由于电极沿如图所示的环路分布在各球囊腔室628和630中，所以位于瓣膜各侧的电极和瓣膜之间的间距将保持基本恒定以使得能够在不削弱冲击波强度的情况下治疗整个主动脉瓣膜的两侧。
图12是可用于本发明实施例中的具有电极结构的血管成形术导管的放大了比例的局部侧视图，其中电极布置在串联电路中。可见导管710包括血管成形术球囊726，该球囊与长形绝缘载体721成密封关系地承载在该长形绝缘载体的远端处。与前面的实施例中一样，载体具有导引线内腔729。
如图所示延伸到载体721的远端然后朝其近端向回延伸的导体740嵌埋在载体721内。在沿载体721和导体740的各个点，载体721的多个部分被除去。导体的多个对应部分也被除去。各被除去的导体部分形成电极对。例如，被除去的部分742形成电极对743。类似地，被除去的部分744和746分别形成电极对745和747。开口742、744和746的一侧涂覆有导电材料以使得各电极对中的一个电极743a、745a和747a的表面积大于其对应的另一电极的表面积。
各电极对743、745和747形成冲击波源。如在图13中可见，电极对743、745和747布置在串联电路中。它们经连接器732与高电压源730连接。各电极对之中较大的电极743a、745a和747a确保所有电极对在高电压施加在整个冲击波源串上时都将可靠地起弧。
图14是体现本发明的冲击波血管成形术系统800的简化示意图，其中冲击波源电极布置在多个串联电路中，各串联电路独立启用。为此，系统800包括经连接器732与多路选择器734连接的电极对的串联电路802、804和806。多路选择器布置成使各串联电路802、804和806一次一个单独地或以任意组合与高电压源730连接。
图15是根据另一实施例的体现本发明的另一血管成形术系统900的简图，包括扩张血管成形术球囊导管910的侧视图，所述导管包括可选择性地一次一个地与电源联接的多个冲击波源，而图16是示出图15的电极可选择性地与电源联接的方式的时间图。系统900包括导管920以及高电压电源930和连接器934。导管920包括与载体921成密封关系地承载在该载体921上并且配置成用诸如盐水之类的液体充胀的血管成形术球囊926。导管920还包括与球囊926的侧壁成非接触关系地承载在载体921上的电极940、942和944，以及也承载在载体921上的反电极946。电极940、942和944均与高电压源930的多路选择器934连接。当电极被启用时，来自电源930的高电压横跨反电极和所述电极中选定的一个电极施加以形成电弧。该电弧使得形成等离子体。等离子体的形成产生冲击波。因此，各电极940、942和944形成冲击波源。冲击波源经液体传播而冲撞球囊侧壁和钙沉淀物以破碎钙沉淀物。
如在图6中可见，多路选择器934可以一次一个地启用冲击波源。这为各冲击波源保存了全部高电压，从而形成待施加至沿整个球囊的钙沉淀物的最大强度的冲击波。冲击波可以具有可重复的强度。不需要导管纵向移动以处理钙沉淀物。
尽管已经示出和描述了本发明的特定实施例，但是可作出修改，并且因此旨在涵盖所有这种改变和修改，它们都处在本发明的真实精神和范围内。

Claims (16)

1.一种装置，包括：
沿轴向延伸的长形部件；
成密封关系地环绕所述长形部件的一部分的球囊，所述球囊能填充传导流体；
具有分隔开的第一和第二电极的第一电极对以及具有分隔开的第一和第二电极的第二电极对，所述电极对位于所述球囊内并且与该球囊分隔开，其中，所述电极对构造成产生在所述球囊保持完整的同时经液体传播的冲击波；和
能连接至所述第一电极对的第一电极的高电压源，其中所述第一电极对的第二电极连接至所述第二电极对的第一电极，并且所述第二电极对的第二电极能连接至所述高电压源，其中当高压脉冲供应至所述第一和第二电极对时，在所述传导流体内产生第一电弧而允许电流流过所述第一电极对，并且在所述传导流体内产生第二电弧而允许电流流过所述第二电极对，借此形成从所述第一电极对中的第一电极到所述第二电极对中的第二电极的串联连接。
2.根据权利要求1所述的装置，其特征在于，每个电极对中的一个电极具有比该电极对中的另一个电极的表面积大的表面积。
3.一种装置，包括：
沿轴向延伸的长形部件；
成密封关系地环绕所述长形部件的一部分的球囊，所述球囊能填充传导流体；
具有分隔开的第一和第二电极的第一电极对、具有分隔开的第一和第二电极的第二电极对和具有分隔开的第一和第二电极的第三电极对，所述电极对位于所述球囊内并且与该球囊分隔开，其中，所述电极对构造成产生在所述球囊保持完整的同时经液体传播的冲击波；和
能连接至所述第一电极对的第一电极的高电压源，其中所述第一电极对的第二电极连接至所述第二电极对的第一电极，所述第二电极对的第二电极连接至所述第三电极对的第一电极，并且该第三电极对的第二电极能连接至所述高电压源，其中，当高压脉冲供应至所述第一、第二和第三电极对时，在所述传导流体内产生第一电弧而允许电流流过所述第一电极对，并且在所述传导流体内产生第二电弧而允许电流流过所述第二电极对，并且在所述传导流体内产生第三电弧而允许电流流过所述第三电极对，借此形成从所述第一电极对中的第一电极到所述第三电极对中的第二电极的串联连接。
4.根据权利要求1或2所述的装置，其特征在于，该装置还包括具有分隔开的第一和第二电极的第三电极对以及具有分隔开的第一和第二电极的第四电极对，其中所述第三电极对的第二电极连接至所述第四电极对的第一电极，所述装置还包括多路选择器，该多路选择器用于使所述高电压源选择性地连接至所述第一和第二电极对或所述第三和第四电极对。
5.根据权利要求4所述的装置，其特征在于，所述第二电极对的第二电极和所述第四电极对的第二电极能连接至公共导体，该公共导体提供到所述高电压源的返回路径。
6.根据权利要求1或2所述的装置，其特征在于，所述电极对中的至少两对沿着所述长形部件在纵向上分隔开。
7.根据权利要求1或2所述的装置，其特征在于，所述长形部件包括导引线内腔。
8.根据权利要求1或2所述的装置，其特征在于，所述球囊是单腔室血管成形术球囊。
9.根据权利要求1或2所述的装置，其特征在于，所述球囊包括构造用于治疗心脏瓣膜的两个腔室。
10.一种装置，包括：
沿轴向延伸的长形部件；
成密封关系地环绕所述长形部件的一部分的球囊，所述球囊能填充传导流体；
位于所述球囊内并且与该球囊分隔开的多个电极对，其中，所述电极对构造成产生在所述球囊保持完整的同时经液体传播的冲击波；
能连接至所述电极的高电压源；和
多路连接器，并且其中所述多个电极对包括第一组两个电极对，其中一个电极对中的一个电极连接至另一个电极对中的一个电极，所述电极对还包括第二组两个电极对，其中一个电极对中的一个电极连接至另一个电极对中的一个电极，并且所述多路连接器使所述高电压源选择性地连接至所述第一和第二组电极对中的一组或另一组，其中已连接的组通过在所述传导流体内产生的电弧而串联运行，所述电弧允许电流流过每对电极。
11.根据权利要求10所述的装置，其特征在于，每个电极对中的一个电极具有比该电极对中的另一个电极的表面积大的表面积。
12.根据权利要求10或11所述的装置，其特征在于，所述第一组两个电极对中的一个电极和所述第二组两个电极对中的一个电极能连接至公共导体，该公共导体提供到所述高电压源的返回路径。
13.根据权利要求10或11所述的装置，其特征在于，所述电极对中的至少两对沿着所述长形部件在纵向上分隔开。
14.根据权利要求10或11所述的装置，其特征在于，所述长形部件包括导引线内腔。
15.根据权利要求10或11所述的装置，其特征在于，所述球囊是单腔室血管成形术球囊。
16.根据权利要求10或11所述的装置，其特征在于，所述球囊包括构造用于治疗心脏瓣膜的两个腔室。
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