CN112367934A - 治疗躯体管腔中的闭塞物的系统 - Google Patents

治疗躯体管腔中的闭塞物的系统 Download PDF

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CN112367934A
CN112367934A CN201980041113.7A CN201980041113A CN112367934A CN 112367934 A CN112367934 A CN 112367934A CN 201980041113 A CN201980041113 A CN 201980041113A CN 112367934 A CN112367934 A CN 112367934A
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guidewire
insulated
conductive tube
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H·D·阮
C·P·萨艾彼
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Shockwave Medical Inc
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Abstract

本发明提供了一种用于治疗躯体管腔中的闭塞物的系统。该系统可以包括绝缘外护套；长形导电管，其中，绝缘外护套周向地安装在长形导电管周围；和绝缘导丝，该绝缘导丝在其远端处具有螺旋线圈部分。线圈部分包括暴露的远侧末端，并且长形导电管的远侧部分周向地安装在绝缘导丝的远侧线圈部分周围。当在绝缘导丝和长形导电管之间施加电压时，电流配置成从绝缘导丝的暴露的远侧末端流向长形导电管，以产生多个空穴气泡。在替代实施例中，使用长形中心电极代替导电管。

Description

治疗躯体管腔中的闭塞物的系统
相关申请的交叉引用
本申请要求于2018年6月21日提交的美国专利申请62/688,110的优先权，其全部公开内容通过引用结合在本文中。
技术领域
本公开总体上涉及一种用于治疗躯体管腔中的闭塞物的系统。该系统对于慢性总冠状动脉闭塞(“CTO”)、部分冠状动脉闭塞或输尿管中的肾结石是有用的，以恢复管腔(例如动脉或输尿管)中的正常流动。
背景技术
在血管成形术或外周血管成形术程序中，使用血管成形术球囊来扩张病灶(例如钙化病灶)并恢复动脉中的正常血流。在一些示例中，将血管成形术球囊推进到脉管系统中(例如，沿着导丝)，直到该球囊与钙化斑块对齐。然后用流体对球囊加压，从而使血管扩张以允许血液流动。
最近，已经开发了一种系统，其中，将电极布置在血管成形术球囊中。当球囊最初定位在障碍物附近时，向电极施加一系列高压脉冲，以产生一系列冲击波。该冲击波使钙化病灶破裂。当病灶破裂时，可以以更柔和的方式使球囊扩张，从而扩张血管并改善循环。
在美国专利8,856,371、8,747,416和9,642,673中可以发现与后一种类型的装置有关的更多信息。还开发了冲击波技术，以治疗心脏瓣膜(U.S.2018/0098779)和导丝设计(U.S.9,730,715)。美国专利公开2018/03640482描述了一种前向冲击波装置。这些专利文件中的每一个都通过引用结合在本文中。
动脉有时被例如血栓、斑块、纤维斑块和/或钙沉积物完全或部分闭塞。当出现这种情况时，医生必须首先穿过闭塞物，然后将血管成形术球囊和/或其他工具沿着动脉向下游送入所需的阻塞位置，以执行所需的程序。然而，在某些情况下(例如CTO)，闭塞物如此紧密和牢固，使得难以使治疗装置进入远端血管的真正管腔中。
CTO仍然是经皮冠状动脉介入治疗中的挑战，以及对外周的挑战，导致严重的肢体缺血和截肢。首先，许多当前可用的设备无法物理穿过CTO的坚韧的近端帽或远端帽(逆行方法)。在某些情况下，尝试使用软导丝刺穿CTO帽会导致弯曲(例如，使导丝偏斜至内膜下通道或侧支)。另一方面，更硬的导丝在被迫抵靠CTO时可能损坏动脉壁。此外，一些当前可用的设备通过产生强烈的机械振动来破坏CTO，但是振动的强度可能损坏动脉壁，并且使系统的耐用性降低，并且更难控制。
对于在身体的其他部位形成的闭塞物，例如输尿管中的肾结石，存在类似的问题。
发明内容
本发明提供了一种用于治疗诸如血管或输尿管的管腔中的诸如CTO或肾结石的闭塞物的系统。在一些实施例中，该系统包括绝缘外护套、长形导电管和绝缘导丝，其中，绝缘外护套周向地安装在长形导电管周围，该绝缘导丝在其远端处具有螺旋线圈部分。线圈部分包括暴露的远侧末端。长形导电管的远侧部分周向地安装在绝缘导丝的远侧线圈部分周围。当在绝缘导丝和长形导电管之间施加电压时，电流配置成从绝缘导丝的暴露的远侧末端流向长形导电管，以使其周围的流体电离，并且产生多个空穴气泡和与气泡相关联的动力学特性(塌缩、喷射等)。
在一些实施例中，一种用于治疗诸如血管或输尿管的管腔中的闭塞物的方法包括使治疗装置在管腔中前进，以接触闭塞物。治疗装置包括：绝缘外护套；长形导电管，其中，绝缘外护套周向地安装在长形导电管周围；和绝缘导丝，该绝缘导丝在其远端处具有螺旋线圈部分，其中，线圈部分包括暴露的远侧末端，并且长形导电管的远侧部分周向地安装在绝缘导丝的远侧线圈部分周围。该方法还包括向治疗装置的远端注射导电流体(即生理盐水、盐水与血管造影剂的混合物等)；以及在绝缘导丝和长形导电管之间施加电压，以使电流从绝缘导丝的暴露的远侧末端流向长形导电管，从而产生多个空穴气泡和与气泡相关联的动力学特性(塌缩、喷射等)。
在一些实施例中，公开了一种用于治疗躯体管腔中的闭塞物的系统。该系统包括绝缘导丝，该绝缘导丝在其远端附近具有螺旋线圈部分，并且该绝缘导丝的远侧末端的一部分绝缘被去除，以限定电极。该系统还包括长形的中心电极，其远端容纳在绝缘导丝的螺旋线圈部分中。在一个优选实施例中，该系统还包括绝缘管，其位于中心电极的远端周围，并且位于绝缘导丝的螺旋线圈部分中。最后，提供了一种用于覆盖绝缘导丝的线圈部分的管状外壳。绝缘导丝和中心电极的近端可以连接到电脉冲发生器的端子上，从而在使用中，当向中心电极和绝缘导丝施加电压脉冲时，在绝缘导丝和中心电极之间产生一系列空穴气泡。
附图说明
图1是根据一些实施例的用于治疗闭塞的示例性系统的透视图。
图2A是根据一些实施例的治疗系统的示例性气泡产生末端的放大图。
图2B是根据一些实施例的治疗系统的示例性气泡产生末端的剖视图。
图2C是根据一些实施例的治疗系统的示例性气泡产生末端的剖视图。
图3是根据一些实施例的治疗系统的另一示例性气泡产生末端的透视图。
图4是根据一些实施例的用于治疗闭塞的示例性系统的侧视图。
图5是根据一些实施例的用于治疗闭塞的示例性系统的示意图。
图6是根据一些实施例的用于治疗闭塞的另一示例性系统的示意图。
图7是根据一些实施例的用于治疗闭塞的另一示例性系统的放大图。
图8是图7的系统的透视图。
图9A是图7的系统的端视图。
图9B是图7的系统的剖视图。
图10是根据一些实施例的另一示例性气泡产生末端系统的透视图。
具体实施方式
以下描述阐述了示例性方法、参数等。然而，应当意识到，这种描述并非旨在限制本公开的范围，而是旨在描述示例性实施例。
本文描述了用于治疗诸如CTO或输尿管中的肾结石的闭塞物的示例性系统和方法。根据一些实施例，治疗系统包括前向气泡产生末端，其在管腔内前进以接触闭塞物。前向气泡产生末端包括电极，当设置有电压较低和PRF(脉冲重复频率)较高的发生器时，该电极形成等离子弧，进而导致空穴气泡。空穴气泡产生机械振动、湍流、喷射和/或强力塌缩，以破坏闭塞物。发生器的输出配置成足以产生电动液压放电和空穴气泡来有效地钻孔，而不足以产生强大的冲击波来损害系统的耐用性。这样，与目前可用的设备相比，机械振动较小。因此，治疗系统不太可能对管腔壁(例如血管壁)造成损坏，并且更易于控制和更耐用。
图1是根据一些实施例的示例性治疗系统100的透视图。该治疗系统包括前向气泡产生末端102(以放大图示出)、绝缘外护套104、安装在绝缘外护套的一定长度上的近侧球囊106、废物导管108以及绝缘导丝110和112。前向气泡产生末端102包括电极，并且参考图2A-C进行详细描述。在操作中，诸如盐水(或盐水对比混合物)的导电流体从绝缘外护套104的近侧开口注入，并且流向远端。当绝缘导丝110和112的近端连接到电压源时，在前向气泡产生末端处经由导电流体产生空穴气泡和/或冲击波。空穴气泡和/或冲击波导致沿着前方的持续机械振动，从而使诸如CTO或肾结石的闭塞物破碎。当注入更多的导电流体时，将诸如碎裂的闭塞块、金属和气泡的碎屑冲向近侧球囊，并且经由废物导管108将其带出管腔。
图2A示出了图1的前向气泡产生末端102的放大图。如图所示，前向气泡产生末端102包括长形导电管208、在绝缘导丝112的远端处的螺旋线圈部分202，以及布置在长形导电管208和螺旋线圈部分202之间的可选的绝缘层206。在所示的示例中，绝缘层206包括沿着纵轴线布置的多个孔204。在一些示例中，长形导电管208可以是不锈钢海波管。绝缘导丝110和112可以是聚酰亚胺绝缘铜导丝。绝缘层206可以是聚酰亚胺管状绝缘体。绝缘层在导丝112的导电芯和长形导电管208之间提供了额外的绝缘层，并且在线圈部分202周围的绝缘存在缺陷和/或遭受损坏(例如，在组装期间刮擦)的情况下是有用的。在一些示例中，前向气泡产生末端102不包括绝缘层206。在一些示例中，可以在线圈部分202和长形导电管208之间使用环氧树脂或氰基胶，以固定两者的相对位置。
图2B示出了前向气泡产生末端102的剖视图。如图所示，绝缘外护套104周向地安装在长形导电管208上。在所示的示例中，长形导电管208的远侧边缘延伸超过绝缘外护套104的远侧边一个距离A。可以基于闭塞物的特性来调节距离A。例如，距离A可以设置成比待钻穿的CTO的钙化帽的厚度更长。如果不这样，将需要不希望地增加穿过轮廓(即，需要钻一个更大的孔来容纳绝缘外护套)。在一些示例中，距离A在0.004″至0.01″的范围内。进一步如图所示，绝缘层206以纵向长度L布置在长形导电管208和螺旋线圈部分202之间。绝缘导丝110的远端焊接在长形导电管208上。
如图所示，绝缘层206的远侧边缘与长形导电管208的远侧边缘对齐。此外，长形导电管208的远侧边缘延伸超过螺旋线圈部分202一个距离B。在一些示例中，距离B在0mm(即，线圈部分的远端与长形管的远侧边缘对齐)至0.5mm的范围内。在一些示例中，当设置距离B以实现最佳配置时，会考虑一个或多个影响操作效率的其他因素，例如导电流体的流速、施加的电压、闭塞物的形状和成分。螺旋线圈部分202以及长形导电管208和绝缘层206的远侧边缘的这种相对定位保证对周围组织的安全性，保护导管免受从末端发出的振动的影响，并且使得沿着前方产生机械振动，从而增加治疗系统在破坏闭塞物方面的强度以及有效性。此外，沿着前方的机械振动以及沿着前方的连续流速导致钻出(例如尺寸、形状)一致的孔，从而使治疗系统更易于操作。在一些示例中，治疗系统构造成在钙化材料中钻出直径约为1mm的孔。
在一些示例中，调节盐水或盐水/血管造影剂混合物的流量，以避免过热问题，并且控制钻孔的效率和速率。在一些示例中，流速构造成在1至30mL/min的范围内，以提高钙化结构的易碎性。
在示例性操作中，当绝缘导丝110和112的近端分别连接在发生器的负极端口和正极端口上时，电流从绝缘导丝112的远端210流向长形导电管208。电流可以导致在绝缘导丝112的远端210和长形导电管208的内径之间(例如，在绝缘层206的远侧边缘203上或在206中的孔204中)形成多个等离子弧。等离子弧以受控的方式产生空穴气泡(以特定的速率，每次一个)，进而在导电流体中导致机械振动以及与气泡动力学相关的其他影响，例如塌缩、湍流、喷射等(例如，经由气泡的扩张和塌缩)。机械振动用于破坏或消除闭塞物。与在上述现有技术的冲击波发生系统中使用的发生器相比，用于该系统的发生器构造成以较高的脉冲重复频率产生电压较低的脉冲，从而使冲击波的强度最小，并且使泡沫的生长与塌缩最优化和最大化。例如，在现有技术的系统中，每个脉冲可能是约3000伏，重复频率为1Hz。在该系统中，电压可以低于1000伏，重复频率范围为14到200Hz。在优选实施例中，重复频率可以高达800Hz。
由于在操作中，等离子弧对电极产生腐蚀，因此螺旋线圈部分202和/或线圈部分上的绝缘随着时间而分解并缩短。类似地，绝缘层206和长形导电管208的远侧边缘可能由于使用而分解。线圈部分、绝缘层和长形导电管的分解速率可能基于每个组件的物理特性(例如导丝的直径、导丝的特性、绝缘层的厚度)所施加的电压的极性、所施加的电压的大小而不同。例如，较细的、连接到较高的电压源和/或连接到正极电压端口的导丝腐蚀地更快。在一些情况下，在螺旋线圈部分202被广泛使用之前，在绝缘层206的远侧边缘203上产生等离子弧。然而，当螺旋线圈部分202由于使用而缩短时，绝缘导丝112的远端210与绝缘层206的远侧边缘之间的距离增大。由于距离增大，不再在绝缘层206的远侧边缘203上产生等离子弧。相反，当电流从螺旋线圈部分202的远端210流向长形导电管208的内径时，在绝缘层206中的一个孔204(例如定位成最靠近缩短的螺旋线圈部分的远端210的孔)中产生等离子弧。如图2A所示，沿着绝缘层206的纵轴线设置有多个孔，因此，即使螺旋线圈部分202缩短，也允许形成等离子弧，从而提高治疗系统的耐用性。换句话说，当装置(即电极)腐蚀时，导电层中的孔旨在成为新的火花区域。在一些示例中，多个孔布置成螺旋形的取向，以与线圈对齐，从而控制最大电弧长度。在一些示例中，所施加的电压被维持较长的时间段(例如几分钟)，以实现空穴气泡的连续产生和最终的穿过。应当注意，当线圈部分腐蚀时，空穴气泡的产生位置将改变。在所示的实施例中，空穴气泡的产生位置将围绕导电管208的外围周向旋转。
在一些示例中，可以在操作期间调节各种参数，以减慢或甚至消除电极的腐蚀。例如，可以调节气泡产生/发射的频率(每分钟的脉冲数)，以控制末端腐蚀、耐用性和钻孔时间。可以通过减小电容(这种电容改变可以根据需要改变速度)或通过减小电流来控制气泡的产生频率。作为另一示例，可以根据钻孔时间来调节所施加的电压，以控制发射极腐蚀和装置耐用性，同时根据钻孔时间来保持频率恒定。此外，可以在相当于一部分处理时间(例如该时间的10％至100％)的时间段内使电极的极性反转，同时根据钻孔时间来保持电压和频率恒定，以控制电极磨损和提高装置的耐用性。此外，可以选择导丝绝缘的厚度，以控制导丝的耐用性。
通过引用结合在本文中的美国专利10,226,265教导了用于转换位于导电流体中的电极对的极性的各种方法。那些类型的方法可以与本主题装置一起使用。特别地，为了保持峰值声音输出，火花间隙应当恒定。当电极侵蚀时，该间隙可能改变。为了补偿间隙尺寸的这种变化，电极上的极性可以反转。可以使用极性反转频率来帮助控制火花间隙长度的变化。可以基于输出的功率、导丝直径和绝缘体厚度来调节极性反转频率。也可以使发生器检测功率下降，并且自动反转电极上的极性。
图2C是根据一些实施例的治疗系统的示例性气泡产生末端的剖视图。绝缘导丝112的芯部(例如铜芯)的典型直径是0.005″，其具有0.0005″的聚酰亚胺涂层。线圈部分的匝数决定了电极的寿命。在100Hz的交流500V-700V电弧下，一匝可以持续约30-40秒。因此，对于10分钟的程序，线圈部分可以包括约17匝，线圈长度约为0.1″。长形导电管208的长度应当比线圈长度更长，以支撑内部结构。绝缘层206(例如聚酰亚胺绝缘体护套)的厚度可以是0.001″。绝缘层206的外径适配在长形导电管208的内径中。长形导电管208(例如不锈钢海波管)的外径可以在0.035″至0.065″的范围内，厚度为0.002″。导丝芯部(例如铜芯)和长形导电管的内径之间的电弧间隙约为0.004″-0.007″。如果绝缘层206和孔204远离例如管的另一侧，则电弧间隙可以更长。在一些示例中，电弧间隙是使空穴最大化的理想范围。在一些示例中，选择系统的各种尺寸，以与现成的部件兼容。
图3示出了根据一些实施例的治疗系统的替代性前向气泡产生末端300的透视图。前向气泡产生末端300包括从长形导电管208的远端延伸出的多个防损伤臂或叉302。叉302由柔性材料制成，并且被设计成使末端偏转而不穿透管腔壁。在一些示例中，该叉可以涂有弹性体(即硅橡胶)或低硬度聚合物(即聚氨酯)，并且其长度可以为约0.035″。当前向气泡产生末端钻透闭塞物且到达软组织时，柔性叉使末端旋转。此外，前向气泡产生末端300包括多个从长形导电管208的远端延伸出的尖峰304。尖峰304被设计成在线圈部分的远端310和长形导电管208的远侧边缘之间——例如在绝缘层306的远侧边缘上——引导等离子弧。
图4是根据一些实施例的用于治疗闭塞的示例性系统400的侧视图。如图所示，绝缘外护套的近端构成用于注射导电流体(例如盐水)的入口402。入口402还可以用作导管，以在冲洗盐水之后或在冲洗盐水时引入导丝(例如，0.014″导丝)。注入的导电流体有多种用途。首先，当导丝410和412的近端连接在电压源上时，如上文参考图1-3所述，可以在前向气泡产生末端处经由导电流体形成等离子弧。此外，连续注射的导电流体有助于散热和冷却电极。流动还产生了向前的惯性，以帮助气泡向前钻孔并塌缩(和喷射)。在一些示例中，调节流速以控制钻孔效率和速率。此外，导电流体在前向气泡产生末端处冲刷通过线圈部分，并且将诸如碎裂的闭塞块、金属和气泡的碎屑从前向气泡产生末端401带向近侧球囊406。近侧球囊在充气时捕获碎屑，并防止该碎屑进入主动脉。如图所示，导管404延伸穿过近侧球囊406，导管404的远端409用作废物入口，以接收冲洗后的碎屑，并且将碎屑运送到导管的近端处的废物出口408。在一些示例中，在导管404的近端处进行抽吸，以促进清除碎屑。快速清除碎屑有助于恢复空穴。
图5是用于治疗闭塞的示例性系统500的示意图，其示出了本发明的其他方面。系统500还包括具有输液泵504和发生器506的控制台502。输液泵使导电流体(例如盐水)经由冲洗管腔流向前向气泡产生末端。在一些示例中，可以使用辅助泵来抽吸和清除碎屑。发生器用作前向气泡产生末端处的电极的电压源。脉冲的电压在500至3000伏范围内，更优选地在600至1000伏范围内。为了避免产生过多的热量，适合于CTO穿透的理想电能非常低(每个脉冲在5至50mJ之间)，更优选地为30mJ。电流范围为1-15安培。产生脉冲的重复频率在14至800Hz的范围内。在一些示例中，该系统还包括可视化系统和/或转向系统，以适当地导航(例如侧分支)和放置前向气泡产生末端。替代地或附加地，前向气泡产生末端可以由在荧光镜导向下容易看到的不透射线的材料制成。因此，可以使用填充有硫酸钡的材料、钨或其他不透射线的材料或者填充有不透射线材料的材料来代替钢，从而可以追踪该装置。
在使用中，可以将导丝推进穿过装置中的中心开口区域，并且推向在闭塞物中钻出的孔或正在钻的孔。例如，可以推进导丝穿过钻孔，以引导治疗系统的推进，该治疗系统继续钻孔，直到穿过闭塞物。在一些示例中，可以推进导丝穿过长形导电管(例如，从盐水入口402)，更具体地，穿过气泡产生末端的线圈部分的中心。在穿过闭合物之后，可以抽出前向气泡产生末端，而可以保留导丝，以允许诸如血管成形术球囊或LithoplastyTM球囊的其他工具通过导丝入口进入。Lithoplasty是受让人对其血管内碎石术(冲击波)导管的商标。如下所述，在钻孔之后，可以将血管成形术球囊导管穿过钻出的孔推进到闭塞物的远端，并且与闭塞物对齐。
图6是根据一些实施例的用于治疗闭塞的另一示例性系统600的示意图。该治疗系统可以单独使用或与血管成形术球囊602结合使用。在一些示例中，前向气泡产生末端首先在管腔(例如血管或输尿管)中前进，以接触闭塞物，从而根据上述程序在该闭塞物上钻孔。然后，球囊前进到病灶处。然后用流体对球囊602加压，以使管腔扩张，从而增大流动(例如血流)。如上所述，可以通过穿过装置中心的导丝来帮助球囊前进和定位。
作为替代，血管成形术球囊是碎石术球囊，并且冲击波发生器可以布置在球囊602中。冲击波发生器可以采取例如一对电极的形式。当球囊602与闭塞物的远端对齐，并且在电极上施加高电压脉冲时，将形成冲击波，该冲击波传播通过流体，并且撞击在球囊的壁和闭塞物上。反复的冲击波破坏闭塞物，而不损坏周围的软组织。在一些示例中，可以沿着与导管的轴线垂直的轴线产生冲击波(而不是指向前方)，使其治疗闭塞的不同部分。然后可以使血管成形术球囊602扩张，以进一步打开管腔。如图6所示，控制台603包括选择器开关604，其用于在“CTO”和“LithoplastyTM”之间进行选择，以在为前向气泡产生末端提供较低电压脉冲和为球囊602中的冲击波发生器提供较高电压脉冲之间切换电压源。在该示例中，近侧球囊可以放置在碎石术球囊的任一侧。
图7至图9示出了本发明的治疗系统的替代实施例。与上述实施例相似，图7至图9的实施例在绝缘导丝712的远端处包括螺旋线圈部分702。此外，线圈的远端不绝缘，而是构成一个电极。与上述实施例包括外部圆柱形管形式的第二导体不同，在该实施例中，第二导体是圆柱形中心电极720的形式。
中心电极720的远端容纳在绝缘导丝的线圈部分702中。在优选实施例中，绝缘管706围绕中心电极的远端。绝缘管包括多个孔704，当绝缘导丝的线圈部分在使用期间腐蚀时，该孔704为传导的电流提供附加路径。在优选实施例中，在绝缘管706的外表面和线圈部分702的内表面之间形成环形通道730。该通道可以用于向装置的远侧末端供应导电流体。由于导丝712是绝缘的，因此可以将装置构造成没有绝缘管706。
圆柱形外壳724围绕装置的远端。壳体可以由诸如不锈钢的金属制成。替代地，壳体可以由诸如聚醚醚酮(PEEK)的非金属或诸如VespelTM的聚酰亚胺基塑料制成。该材料应当耐热，并且提供一定的刚度以穿过闭塞物。外壳的近端部分728由更柔性的材料制成，以促进装置前进通过循环系统。
可以与上述实施例相似的方式使用图7至图9的实施例。简而言之，中心电极和绝缘导丝的近端连接在电源上，该电源产生重复频率为每秒几百个脉冲的脉冲。脉冲在装置的远端处的导电流体中产生空穴气泡。空穴气泡产生机械振动，该机械振动在闭塞处振下碎片。
如在上述实施例中那样，在操作期间，绝缘导丝的线圈部分的端部通常将腐蚀。当导丝腐蚀时，产生空穴气泡的点围绕中心电极的圆周周向移动。如上所述，当线圈腐蚀时，绝缘管706中的孔704为电流提供顺序的路径。
在优选实施例中，中心电极720可移除地安装在装置中。在使用中，在闭塞被打通之后，可以将中心电极移除，从而提供用于插入导丝或其他装置的通道，以进行其他治疗。
图10示出了图7至图9的实施例的变型。在该实施例中，绝缘管706的外表面包括径向突出的间隔件740。间隔件740用于将中心电极720与绝缘导丝712的线圈部分702的内表面隔开。
应当理解，上述内容仅是本发明的原理的示例，并且在不背离本发明的范围和精神的情况下，本领域技术人员可以做出各种修改、改变和组合。例如，上述原理可以用于治疗在身体的任何部位形成的闭塞。本文公开的各种治疗系统的任何变型可以包括本文的任何其他治疗系统或治疗系统的组合所描述的特征。此外，任何方法都可以与所公开的任何治疗系统一起使用。因此，除了受随附权利要求书限制之外，本发明不受限制。对于上述所有变型，不需要顺序地执行方法的步骤。

Claims (37)

1.一种用于治疗躯体管腔中的闭塞物的系统，包括：
绝缘外护套；
安装在所述绝缘外护套的远端中的长形导电管；
绝缘导丝，所述绝缘导丝在所述绝缘导丝的远端处具有螺旋线圈部分，
其中，所述线圈部分包括暴露的远侧末端；
其中，所述线圈部分位于所述长形导电管的远侧部分中；并且
其中，当在所述绝缘导丝和所述长形导电管之间施加电压时，电流配置成从所述绝缘导丝的所述暴露的远侧末端流向所述长形导电管，以产生多个空穴气泡。
2.根据权利要求1所述的系统，还包括布置在所述绝缘导丝的远侧线圈部分与所述长形导电管之间的绝缘层。
3.根据权利要求1所述的系统，其中，所述长形导电管连接在接地导丝上。
4.根据权利要求3所述的系统，还包括电压源，所述电压源连接在所述接地导丝的近端和所述绝缘导丝的近端上。
5.根据权利要求2所述的系统，其中，所述绝缘层包括沿着所述绝缘层的纵轴线布置的多个孔。
6.根据权利要求1所述的系统，其中，在所述绝缘层的远侧边缘上产生多个等离子弧。
7.根据权利要求5所述的系统，其中，在布置于所述绝缘层上的所述多个孔中的一个孔中产生多个等离子弧。
8.根据权利要求1所述的系统，其中，所述绝缘外护套包括用于接收导电流体的入口。
9.根据权利要求8所述的系统，还包括：
安装在所述绝缘外护套的长度上的近侧球囊；和
废物导管，该废物导管用于接收由注入的导电流体携带的碎屑。
10.根据权利要求1所述的系统，该系统在所述长形导电管的远端处还包括多个叉，其中，所述多个叉构造成防止所述长形导电管的远端穿透所述管腔。
11.根据权利要求1所述的系统，该系统在所述长形导电管的远端处还包括多个尖峰，其中，所述多个尖峰构造成在所述绝缘层的远侧边缘上产生多个等离子弧。
12.根据权利要求1所述的系统，其中，所述长形导电管的远端构造成延伸超过所述绝缘导丝的远侧线圈部分，从而在朝向所述闭塞物的向前方向上产生所述多个空穴气泡。
13.根据权利要求1所述的系统，其中，所述多个空穴气泡构造成产生振动频率在14Hz至800Hz的范围内的机械振动。
14.一种用于治疗躯体管腔中的闭塞物的方法，包括：
使治疗装置在所述管腔中前进，以接触所述闭塞物，其中，所述治疗装置包括：
绝缘外护套；
安装在所述绝缘外护套的远端中的长形导电管；
绝缘导丝，所述绝缘导丝在所述绝缘导丝的远端处具有螺旋线圈部分，其中，所述线圈部分包括暴露的远侧末端，并且所述线圈部分位于所述长形导电管的远侧部分中；和
向所述治疗装置的远端注射导电流体；和
在所述绝缘导丝和所述长形导电管之间施加电压脉冲，以使电流从所述绝缘导丝的暴露的远侧末端流向所述长形导电管，从而产生多个空穴气泡。
15.根据权利要求14所述的方法，其中，所述治疗装置还包括连接在废物入口上的近侧球囊，所述方法还包括：
当产生所述多个空穴气泡时，在所述废物入口处接收由注入的导电流体携带的碎屑。
16.根据权利要求14所述的方法，其中，所述多个空穴气泡构造成在所述闭塞物上钻孔。
17.根据权利要求16所述的方法，还包括：
推进血管成形术球囊导管穿过所述钻孔，以与所述闭塞物对齐；和
扩张所述血管成形术球囊。
18.根据权利要求17所述的方法，还包括：在扩张所述血管成形术球囊之前，沿着与所述导管的轴线垂直的轴线从所述球囊内部产生一个或多个冲击波。
19.根据权利要求16所述的方法，还包括：
推进导丝经由所述绝缘导丝的所述线圈部分的中心穿过所述钻孔；和
在所述导丝上推进一个或多个工具。
20.根据权利要求1所述的系统，其中，所述管腔是血管。
21.根据权利要求1所述的系统，其中所述管腔是输尿管。
22.一种用于治疗躯体管腔内的闭塞物的系统，包括：
绝缘的管状外护套；
在所述外护套的远端附近位于外护套中的绝缘导丝，所述绝缘导丝是螺旋线圈，所述绝缘导丝的远侧末端的一部分绝缘被去除，以限定电极；和
位于所述绝缘导丝周围的导电管，所述导电管和所述绝缘导丝的近端能连接到电脉冲发生器的端子上，从而在使用中，当向所述导电管和绝缘导丝施加电压脉冲时，在所述绝缘导丝的所述电极和所述导电管之间产生一系列空穴气泡，其中，当所述绝缘导丝的远侧末端在使用期间磨损时，所述电极朝着所述绝缘导丝的近端移动。
23.根据权利要求22所述的系统，还包括位于所述绝缘导丝和所述导电管之间的绝缘管，所述绝缘管具有沿着其纵轴线布置的多个孔，以在所述绝缘导丝的所述电极与所述导电管之间提供顺序的电流路径。
24.根据权利要求22所述的系统，还包括穿过螺旋的绝缘导丝的中心的导丝。
25.根据权利要求22所述的系统，还包括泵，所述泵用于将导电流体注入所述管状外护套的近端中，所述流体从其远端离开。
26.根据权利要求22所述的系统，还包括连接在所述绝缘导丝和所述导电管的近端上的电压脉冲发生器，所述电压发生器产生频率在14至800赫兹之间的脉冲。
27.根据权利要求22所述的系统，还包括位于所述绝缘的管状外护套的远端和近端之间的球囊，以捕获碎屑。
28.根据权利要求22所述的系统，其中，所述绝缘导丝的所述线圈构造成使得当所述绝缘导丝磨损时，空穴气泡的产生位置将围绕所述导电管的外围周向旋转。
29.一种用于治疗躯体管腔中的闭塞物的系统，包括：
绝缘导丝，该绝缘导丝在其远端附近具有螺旋线圈部分，并且所述绝缘导丝的远侧末端的一部分绝缘被去除，以限定电极；
长形中心电极，其远端容纳在所述绝缘导丝的所述螺旋线圈部分中；
绝缘管，该绝缘管位于所述中心电极的远端周围，并且位于所述绝缘导丝的所述螺旋线圈部分中；和
覆盖所述绝缘导丝的所述线圈部分的管状外壳，所述中心电极和所述绝缘导丝的近端能够连接到电脉冲发生器的端子上，从而在使用中，当向所述中心电极和所述绝缘导丝施加电压脉冲时，在所述绝缘导丝的电极和所述中心电极之间产生一系列空穴气泡，其中，当所述绝缘导丝的远侧末端在使用期间磨损时，所述电极朝着所述绝缘导丝的所述近端移动。
30.根据权利要求29所述的系统，其中，在所述绝缘管的外表面与所述螺旋线圈部分的内表面之间限定环形空间，以限定流体管腔。
31.根据权利要求30所述的系统，还包括泵，所述泵用于将导电流体注入所述流体管腔的近端中，所述流体从其远端离开。
32.根据权利要求29所述的系统，其中，所述中心电极可移除，并且在移除时限定了用于容纳导丝的管腔。
33.根据权利要求29所述的系统，其中，所述外壳的远侧区域由刚度比所述外壳的近侧区域的刚度更大的材料制成。
34.根据权利要求29所述的系统，其中，所述绝缘管包括沿着其纵轴线布置的多个孔，以在所述绝缘导丝的所述电极与所述中心电极之间提供顺序的电流路径。
35.根据权利要求29所述的系统，其中，所述绝缘管的外表面包括多个径向突出的间隔件，以使所述中心电极与所述绝缘导丝的所述螺旋线圈部分之间保持隔开。
36.根据权利要求29所述的系统，还包括连接在所述中心电极和所述绝缘导丝的近端上的电压脉冲发生器，所述电压发生器产生频率在14至800赫兹之间的脉冲。
37.根据权利要求29所述的系统，其中，所述绝缘导丝的所述线圈构造成使得当所述绝缘导丝磨损时，空穴气泡的产生位置将围绕所述中心电极的外围周向旋转。
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