CN104540459B - 具有弧预处理的冲击波导管系统 - Google Patents

具有弧预处理的冲击波导管系统 Download PDF

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CN104540459B
CN104540459B CN201380042887.4A CN201380042887A CN104540459B CN 104540459 B CN104540459 B CN 104540459B CN 201380042887 A CN201380042887 A CN 201380042887A CN 104540459 B CN104540459 B CN 104540459B
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J·亚当斯
R·霍姆伯格
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Abstract

一种冲击波导管系统和方法以减少的能量产生冲击波。所述系统包括导管和电源。导管具有细长载体和在载体周围与其密封关联的气囊。将气囊布置为在其中接收使气囊膨胀的流体。导管还包括弧发生器，该弧发生器包括在气囊内的至少两个电极。电源被耦接到至少两个电极并且被配置为在至少两个电极中的一个处生成气泡，并且接着在此之后快速扩张气泡以在气囊内形成冲击波。

Description

具有弧预处理的冲击波导管系统
优先权声明
本申请要求于2012年8月17日提交的美国临时专利申请序列号No.61/684,398和于2013年2月26日提交的美国专利申请序列号No.13/777,807的权益，其每个的公开通过引用整体并入本文中。
技术领域
本发明涉及一种用于经皮冠状动脉血管成形或外周血管成形的处置系统，在该处置系统中，使用扩张导管来穿过损伤以便扩张损伤并恢复动脉中的正常血流。当损伤是动脉壁中的钙化损伤时这尤其有用。
背景技术
目前利用血管成形气囊处置的钙化损伤需要高压(有时高达10-15或甚至30个大气压)来破坏钙化的斑块并将其推回到血管壁中。随着这样的压力对血管壁造成创伤，这能够导致血管回弹、切开、血栓形成以及高级别再狭窄。非同心的钙化损伤当暴露于高压下时能够导致对自由的血管壁的过度压力。血管成形气囊当膨胀到高压时能够具有其将扩张至的特定最大直径但是在同心损伤下的血管中的开口将通常小得多。当提高压力以打开血管的通路时，气囊将被局限于钙化损伤(在其破碎之前)中的开口大小。当压力建立时，在气囊中存储了巨大量的能量直到钙化损伤破坏或破裂。该能量之后被释放并导致气囊至其最大尺寸的快速扩张并且可以压迫并损害血管壁。
近来，一种新的系统和方法已经被打算用于破坏例如动脉或静脉中的钙沉积。这样的系统在例如于2009年12月17日公开的美国专利公开号No.2009/0312768中描述。其中描述的实施例包括在其远端处具有诸如血管成形气囊的气囊的导管，该气囊被布置为利用流体来膨胀。在气囊内设置冲击波发生器，该冲击波发生器可以采取例如电极对的形式，该电极对通过连接器在导管的近端处被耦接到高压源。当邻近静脉或动脉的钙化的区域放置气囊并且在电极两端施加高压脉冲时，形成冲击波，该冲击波通过流体传播并撞击气囊壁和钙化的区域。重复的脉冲在不损坏周围软组织的情况下破坏钙。
每个高压脉冲导致在电极两端形成弧。该弧进而导致形成蒸汽气泡。每个弧在短时间段产生强烈的热和能量。在微小血管成形气囊的小范围内部，流体能够变暖并且变得足够热以损坏组织，除非采取步骤来控制释放到流体中的能量的量。在身体温度以上仅一两摄氏度的温度升高能够导致组织损坏。
确保蒸汽气泡和弧的形成的能量的量能够在弧间具有很大变化。因此，如果使用相同量的能量来确保每个气泡和弧的形成，则将使用比必需能量更多的能量来形成许多气泡和弧。可以导致对气囊内的流体的过度加热。此外，因为在电极处更大的施加的能量生成更大的气泡，所以过多的能量将产生比能够过度压迫气囊壁所需气泡更大的气泡。
另一考虑是由施加到电极的高压表示的能量的量。每个高压脉冲移除电极材料的一部分。因为电极的大小必须小以便适合放到钙化的静脉或动脉中，所以电极仅能够维持足以形成产生电弧的冲击波的有限数量的高压脉冲。
因此，在本领域中需要能够控制产生气泡和弧所需的能量的量。还将期望能够以比可能到此的能量更少的能量来产生气泡和弧。本发明解决这些问题和其他问题。
发明内容
在一个实施例中，一种冲击波导管系统包括导管和电源。导管具有细长载体和在载体周围与其密封关联的气囊。气囊被布置为在其中接收使气囊膨胀的流体。导管还包括弧发生器，该弧发生器包括在气囊内的至少两个电极。电源被配置为在至少两个电极两端输送在至少两个电极中的一个处生成气泡的第一电压，并且接着在此之后在至少两个电极两端输送第二电压以在至少两个电极两端生成弧以便快速扩张气泡以在气囊内形成冲击波。
第二电压显著大于第一电压。第一电压大约为50伏特，而第二电压在300伏特到10000伏特之间。
电源可以被配置为将第一电压保持第一时间段并且将第二电压保持第二时间段，第一时间段在长度上显著长于第二时间段。第一时间段可以大约为两毫秒并且第二时间段可以大约为半微秒。
气囊可以是血管成形气囊。
根据其他实施例，一种冲击波导管系统包括导管和电源。导管具有细长载体和在载体周围与其密封关联的气囊。气囊被布置为在其中接收使气囊膨胀的流体。导管还包括弧发生器，该弧发生器包括在气囊内的至少两个电极。电源被耦接到至少两个电极并且被配置为在至少两个电极中的一个处生成气泡，并且接着在此之后快速扩张气泡以在气囊内形成冲击波。
在另一实施例中，一种产生电液冲击波的方法包括在第一时间段期间在流体内生成气泡，并且在此之后，在第二时间段期间快速扩张气泡。
生成步骤可以包括在流体内提供至少两个电极并且在第一时间段期间向至少两个电极输送第一电压。
扩张步骤可以包括在第二时间段期间向至少两个电极输送第二电压。第二电压可以大于第一电压并且第一时间段可以长于第二时间段。第二电压可以在300伏特到10000伏特之间。第一时间段可以大约为两毫秒并且第二时间段可以大约为半微秒。
附图说明
利用所附权利要求书中的特性来阐述被认为是新颖的本发明的特征。通过参考结合附图作出的以下描述可以最好地理解与发明的进一步特征和其优点的本发明，在所述附图的若干附图中类似的附图标记指示相同的元件，并且其中：
图1是有利实现本发明的各种实施例的冲击波导管系统的简化侧视图；
图2是在图1的导管中采用的电极结构和电源的部分角度的简化视图；
图3是图示如在现有技术中所实施的在一对电极之间形成电液冲击波的电压和电流的典型电压和电流波形的图；
图4是在放大的尺度上图示在电极处的大气泡的生成的简化图；
图5是在放大的尺度上图示在电极处的小气泡的生成的简化图；
图6是根据本发明的实施例的用于在血管成形电弧冲击波血管成形导管系统中使用的电源的示意图；以及
图7是图示如根据本发明的实施例所实施的可以从图6的电源电路导出以在一对电极之间形成电液冲击波的电压和电流的电压和电流波形的图。
具体实施方式
图1是可以有利地利用本发明的各种实施例的类型的血管成形气囊导管系统10的简化侧视图。系统10包括导管11和电源30。
导管11包括诸如空心护套12的细长载体和在密封16处在护套12周围与其密封关联地形成的扩张气囊14。气囊14具有管状延伸18，管状延伸18与护套12一起形成用于准许流体进入到气囊14中的通道20。护套12具有纵向内腔22，通过纵向内腔22可以接纳导引线(未示出)以用于将导管11引导到例如静脉或动脉内的期望位置。
导管11还包括在气囊14内的弧发生器24。如可以在图2中最好地看到的弧发生器包括引线25，引线25具有同轴配置的电极对，电极对包括电极26和28。如可以在图2中看到的，电极26形成中心电极并且电极28在中心电机26周围同中心地形成环形电极。如以上所提到的，护套12与气囊延伸18一起形成通道20，通过通道20可以准许诸如盐水的流体进入到气囊中以使气囊膨胀。通道20还允许将引线25的电极26和28馈送到气囊14中。
如可以在图1和2中看到的，电极26和28附接到高压脉冲的源30。如可以在图2中看到的，中心电极26耦接到源30的正端子34并且环形电极28耦接到源30的负端子36。电极26和28可以由诸如不锈钢的金属形成并且保持分开受控距离以允许针对给定的施加的电压和电流形成可再生弧。
使用在流体中的电极26与28之间的电弧在流体中生成冲击波。施加到电极26和28的每个高压脉冲在电极两端形成弧。电压脉冲可以具有如500伏特一样低的幅度，但是优选地，电压幅度在1000伏特到10000伏特的范围内。气囊14可以填充有水或盐水以便将气囊轻柔地固定在动脉壁或静脉壁中，例如直接接近钙化损伤。流体还可以包含X射线造影剂以允许在使用期间对导管进行荧光透视观察。一旦利用导引线(未示出)放置导管11，医师或操作者能够开始将高压脉冲施加到电极以形成使钙化斑块破裂的多个离散冲击波。通过流体、通过气囊、通过血液和血管壁将这样的冲击波传导到钙化损伤，在那里能量将在没有由气囊对动脉壁的过多压力的施加的情况下破坏硬化的斑块。
图3是图示如果采用传统现有技术来在诸如电极26和28的一对电极之间形成电液冲击波的电压和电流的典型电压(实线)和电流(虚线)波形的图。这里可以通过参考字符40看到，在电极之间施加3000伏特的电压。低水平电流42流动通过水，在电极上创建气泡。在例如一微秒的延迟D之后，在44处，弧在气泡两端跳跃。在该范例中，弧是200安培并且在电极之间跳跃。当弧开始时，电压快速降低并且当电压脉冲在46处结束时，其降低至零。在该现有技术方法中，延迟D变化很大并且已经被测得为短至90纳秒到长至1000纳秒。脉冲间的延迟D也是不可预测的。当弧电流在44处出现时生成冲击波。因为延迟D不可预测，所以电压脉冲必须具有足够长的持续时间以确保弧将形成。在示例中，该持续时间大约为1.8微秒。固定长的电压的最终结果是向每个脉冲施加比确保弧的出现所需的更多的能量。过剩的能量不必要地加热气囊中的流体。
图4和5图示可变延迟D的原因。有时，如图4中所示出的，在弧60出现之前形成大气泡50。然而，在其他时候，在弧60出现之前形成小气泡52以使弧出现得更快。由流体的电解形成气泡并且大气泡比小气泡需要更久来形成。当在气泡两端的电压足以在间隙形成弧并且变化很大时弧出现。
图6是根据本发明的实施例的用于在血管成形电弧冲击波血管成形导管系统中使用的电源30的示意图。如将看到的，电源在电极两端输送第一低电压以在电极中的一个处预先生成气泡并且在此之后在电极两端输送第二较高电压以快速扩张预先生成的气泡来以时间受控的方式产生弧和冲击波。
源30包括控制逻辑70、第一晶体管72、第二晶体管74以及输出端子76和78。将输出端子76布置为通过连接器38(图1)耦接到冲击波发生器24的中心电极26(图2)并且将输出78布置为通过连接器38耦接到冲击波发生器的外电极28。输出端子连接到3000伏特的源。
首先，控制逻辑70向晶体管72的栅极输送两毫秒(2ms)控制脉冲80。这产生通过电极和电阻器73的低(例如，25ma)电流。施加2ms的低电流在电极中的一个上形成可预测大小的气泡。在2ms之后，控制逻辑70使晶体管74硬导通500纳秒(500ns)。这向电极施加完全的3000伏特。控制逻辑70可以在2ms期间之后立即或在此之后的短时间，例如，在2ms期间之后的10毫秒使晶体管74硬导通。弧和冲击波基本上将立即出现。因为仅施加高压短的时间，此处为500ns，所以向在气囊内的流体输送减少量的能量以用于生成每个冲击波。结果，在气囊内的流体中生成少得多的热。
图7是图示如根据图6的实施例所实施的可以从图6的电源30导出以在电极对26和28之间形成电液冲击波的电压(实线)和电流(虚线)的电压和电流波形的图。首先，当晶体管72导通2ms时在电极两端施加低电压90。低电压确保弧将不会出现在电极两端。然而，低电压的确产生流过电极的低电流92(25ma)。在该2ms期间，在电极中的一个上生成可预测大小的气泡。气泡大小可以由电流的量和施加低电流的时间长度来控制。在2ms期间后，晶体管74硬导通以在电极两端施加完全的3000伏特高压的窄脉冲(500ns)。在该短时间期间，250安培的电流可以在电极之间流动。高电压和电流快速扩张预先生成的气泡并且在短延迟时间DT内导致在96处产生弧和冲击波。弧和冲击波快速被产生，因为气泡已经由低电压90预先生成。电压和电流在98处快速下降至零。
如可以从前述所看到的，施加高压脉冲更短的时间段来产生弧和冲击波，因为气泡已经由前面的低电压和电流预先生成。总体弧能量更低并且蒸汽气泡将更小。这导致对于每个生成的冲击波向在气囊内的流体施加更少的能量。因此对流体加热更少并且在气囊壁上的更少应力。
尽管已经示出和描述了本发明的特定实施例，但是可以进行修改。因此旨在在所附权利要求书中覆盖所有这样的变化和修改，只要所述变化和修改落入如那些权利要求所限定的本发明的真实精神和范围内。

Claims (10)

1.一种冲击波导管系统，包括：
导管，其具有细长载体、在所述载体周围与其密封关联的气囊以及弧发生器，其中将所述气囊布置为在其中接收使所述气囊膨胀的流体，所述弧发生器包括在所述气囊内的至少两个电极；以及
电源，其输送在所述至少两个电极中的一个处生成气泡的在所述至少两个电极两端的第一电压，并且接着在此之后在所述至少两个电极两端输送第二电压以在所述至少两个电极两端生成弧并且快速扩张所述气泡以在所述气囊内形成冲击波。
2.如权利要求1所述的冲击波导管系统，其中所述第二电压显著大于所述第一电压。
3.如权利要求2所述的冲击波导管系统，其中所述第一电压大约为50伏特并且所述第二电压在300伏特到10000伏特之间。
4.如权利要求1所述的冲击波导管系统，其中所述电源被配置为将所述第一电压保持第一时间段并且将所述第二电压保持第二时间段，所述第一时间段在长度上显著长于所述第二时间段。
5.如权利要求4所述的冲击波导管系统，其中所述第一时间段大约为两毫秒并且所述第二时间段大约为半微秒。
6.如权利要求1所述的冲击波导管系统，其中所述气囊是血管成形气囊。
7.一种产生电液冲击波的方法，包括如下步骤：
使用液体膨胀导管的气囊，所述导管具有细长载体、在所述载体周围与其密封关联的所述气囊以及弧发生器，所述弧发生器包括在所述气囊内的至少两个电极；
在电极两端施加第一电压以在第一时间段期间在流体内生成气泡；并且在此之后，
在电极两端施加第二电压以在第二时间段期间快速扩张气泡以在所述至少两个电极两端生成弧，所述快速扩张的气泡形成冲击波。
8.如权利要求7所述的方法，其中所述第二电压大于所述第一电压，并且其中所述第一时间段长于所述第二时间段。
9.如权利要求8所述的方法，其中所述第二电压在300伏特到10000伏特之间。
10.如权利要求8所述的方法，其中所述第一时间段大约为两毫秒并且所述第二时间段大约为半微秒。
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EP2884911B1 (en) 2016-06-22
CN104540459A (zh) 2015-04-22
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US20140052145A1 (en) 2014-02-20
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