CN104736073A - 冲击波导管 - Google Patents

冲击波导管 Download PDF

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CN104736073A
CN104736073A CN201380041288.0A CN201380041288A CN104736073A CN 104736073 A CN104736073 A CN 104736073A CN 201380041288 A CN201380041288 A CN 201380041288A CN 104736073 A CN104736073 A CN 104736073A
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air bag
shock wave
conduit
wave source
inflatable air
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D·霍金斯
J·亚当斯
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Shockwave Medical Inc
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    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • 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
    • 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
    • A61B2017/22005—Effects, e.g. on tissue
    • A61B2017/22007—Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A61B2017/22025—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 applying a shock wave
    • A—HUMAN NECESSITIES
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A—HUMAN NECESSITIES
    • 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
    • A61B2017/22098—Decalcification of valves

Abstract

一种例如用于瓣膜成形的导管(10)包括细长主体(12)和由细长主体(12)承载的可膨胀气囊(14)。气囊(14)具有内表面(16)和外表面(18)。导管(10)还包括在可膨胀气囊内(14)的至少一个冲击波源(20)和随动装置(30)，所述随动装置维持至少一个冲击波源(20)距气囊的内表面(16)大致固定的距离。

Description

冲击波导管
优先权要求
本申请要求于2012年8月6日提交的共同待审的美国临时专利申请序列号No.61/679,911的权益，通过引用将该申请整体并入本文中。
背景技术
患主动脉瓣狭窄的患者通常具有钙化的主动脉瓣叶。用于主动脉瓣狭窄处置的冲击波治疗之前已经在例如美国专利公开号No.2010/0114020A1中描述，其公开通过引用并入本文中。如其中所描述的，瓣膜成形导管包括可利用流体膨胀的气囊。当气囊被膨胀时，其被配置为邻近诸如主动脉瓣的瓣叶的瓣叶。在气囊内，设置冲击波发生器。冲击波发生器包括至少两个电极。当在电极两端施加高电压脉冲时，形成电弧。电弧在流体内产生冲击波，冲击波传播到气囊壁以撞击瓣叶和瓣膜上的钙化。重复的冲击波导致钙化破碎。
冲击波发生器(电极)与上述导管的瓣叶之间的距离可变并且不受控制。已经发现旨在打碎钙沉积的冲击波治疗在距辐射冲击波源的特定距离处是最有效的。当源是没有反射器的点源时这尤其如此。一般地，冲击波的效果随着距源的距离的平方而下降或降低。
当如上所述组合瓣膜成形气囊和冲击波发生器时，在冲击波发生器与气囊壁之间的距离一般当通过由有效处置而引起的气囊扩张和瓣膜成形压力打开瓣膜时增大。当距离变化并变得更大时，治疗效果降低。这增加完整且有效处置所需的时间和冲击波数量两者。因此，需要将治疗效果维持在期望的水平直到正被处置的瓣膜被扩张期望量的冲击波瓣膜成形导管。
发明内容
根据本文中示出和描述的实施例，一种例如可以用于瓣膜成形的导管包括细长主体和由所述细长主体承载的可膨胀气囊。气囊具有内表面和外表面。导管还包括在可膨胀气囊内的至少一个冲击波源和随动装置，该随动装置维持至少一个冲击波源距气囊的内表面基本上固定的距离。
随动装置可以由在可膨胀气囊内的至少一个冲击波源承载。至少一个冲击波源可以是包括电极对的弧发生器。
随动装置可以包括从电极对延伸的至少一个托脚。托脚可以由柔性材料形成。
弧发生器可以包括细长引线。电极对可以由细长引线承载，并且细长引线可以在朝向可膨胀气囊的内表面的方向上偏置。细长引线可以包括至少一个弯曲，该至少一个弯曲将细长引线朝向可膨胀气囊的内表面偏置。
导管还可以包括由细长引线承载的偏置构件，该偏置构件将细长引线朝向可膨胀气囊的内表面偏置。偏置构件可以是弹簧。
至少一个冲击波源可以包括弧发生器。随动装置可以包括由弧发生器承载的托脚并且弧发生器可以朝向可膨胀气囊的内表面偏置。
导管还可以包括框架结构，所述框架结构承载至少一个冲击波源。框架结构可以被布置为随着可膨胀气囊的膨胀而扩张以维持至少一个冲击波源距气囊内表面大致固定的距离。框架结构可以包括邻近至少一个冲击波源的至少一个托脚以维持至少一个冲击波源距气囊内表面大致固定的距离。
在其他实施例中，一种方法包括提供导管的步骤，所述导管包括细长主体、由细长主体承载并且具有内表面和外表面的可膨胀气囊，以及可膨胀气囊内的至少一个冲击波源。该方法还包括以下步骤：将导管插入到患者的静脉或动脉中并且邻近要被处置的解剖结构放置气囊，利用流体使气囊膨胀，使冲击波源在气囊内提供冲击波，所述冲击波通过液体传播以处置解剖结构，并且在由至少一个冲击波源提供冲击波的同时维持至少一个冲击波源距气囊内表面大致固定的距离。
导管还可包括由冲击波发生器承载的随动件，并且维持步骤可以包括将随动件对着气囊内壁偏置。
导管可以包括框架结构，所述框架结构承载至少一个冲击波源。维持步骤可以包括利用可膨胀气囊的膨胀来扩张框架结构以维持至少一个冲击波源距气囊内表面大致固定的距离。
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。本发明的各种描述的实施例与其代表性特征和优点一起可以最好通过参考结合附图的以下描述来理解，在所述附图的若干附图中类似的附图标记识别相同的元件，并且其中：
图1是心脏和在心脏的主动脉瓣内实现本发明方面的导管的部分剖视图；
图2是冲击波发生器的侧视图，所述冲击波发生器可以用于在图1的导管内有利并且所述冲击波发生器实现本发明的方面；
图3是图示当导管正在向心脏的主动脉瓣输送治疗时的导管的图1的心脏的部分剖视图；
图4是图示在对心脏的主动脉瓣的治疗完成时的导管的图1的心脏的部分剖视图；
图5是另一心脏和心脏的主动脉瓣内的实现本发明的另外方面的另一导管的部分剖视图；以及
图6是图示图5的导管的特定方面的爆发规模的部分视图。
具体实施方式
现在参考图1，图1是心脏的主动脉50和在心脏的主动脉瓣52内实现本发明方面的导管10的部分剖视图。导管10大体包括细长主体12、由细长主体12承载的可膨胀气囊14、在可膨胀气囊14内的至少一个冲击波源20以及随动装置30。气囊包括内表面16和外表面18。随动装置30由冲击波源20承载。如随后将看到的，随动装置维持至少一个冲击波源20距气囊的内表面16大致固定的距离。
气囊14可利用诸如盐水的流体通过细长主体12可膨胀。配置气囊使得当被定位在主动脉瓣52内时，其外表面18大致贴合并且紧邻主动脉瓣叶54和其上的钙化56或与主动脉瓣叶54和其上的钙化56相接触。
冲击波源20优选为弧发生器，所述弧发生器产生电弧，所述电弧在气囊14内形成快速扩张和收缩蒸汽泡。快速扩张和收缩蒸汽泡在气囊14内形成冲击波，冲击波在气囊内通过流体传播并且撞击气囊14的内表面16和钙化56。在重复的冲击波之后，钙化破碎以允许主动脉瓣52起作用。随动装置30维持冲击波源20距气囊14的内表面16并且因此距瓣叶54大致固定的距离以在冲击波施加过程期间维持冲击波的充分效果。
图1还示出导管10被布置为接受导引线70。导引通过导引线内腔72并且用来导引导管进入主动脉或静脉以邻近诸如主动脉瓣的要被处置的解剖结构放置气囊。一旦因此放置气囊，则其可以被膨胀并且冲击波治疗开始。
如在图2中可以看到的，冲击波源或发生器20包括细长引线22和由引线22承载的电极对24。电极对24由包括环形电极26和中心电极28的一对同轴设置的电极形成。电压脉冲通过引线22施加在电极26和28两端以引起产生冲击波的弧。
图1的导管10包括两个冲击波源20和20’。冲击波源20’可以与冲击波源20相同。每个冲击波源承载随动装置。在图1的实施例中，弹簧38分别被附接到冲击波源20和20’的引线22和22’并且被附接在冲击波源20和20’的引线22与22’之间中。弹簧28用作偏置构件以迫使冲击波源的电极对和随动装置朝向气囊14的内表面16偏离气囊14的中心轴15。
备选地或附加地，如在图2中可以看到的，引线22可以具有形成在其中的永久弯曲34和35。弯曲以由箭头26指示的方向将电极对24朝向气囊14的内表面16偏置。
因此，图1示出瓣膜成形系统，所述瓣膜成形系统具有根据本发明的一些方面的导管10，导管10包括瓣膜成形气囊14，瓣膜成形气囊14具有设置在其中的两个电极(电极对24)。在主动脉瓣52内示出系统以用于处置瓣叶54上的钙化56。通过弹簧构件38促使电极远离气囊14的中心轴15朝向气囊14的周界。如可以认识到的，弹簧构件可以由装载或偏置在外部承载电极的引线22和22’的弹簧来替换。在严重狭窄的瓣膜52内示出气囊14。在电极上承载的托脚32维持在电极与气囊14的壁之间的并且因此在电极与瓣叶54之间的大致恒定的距离。
另外，图2示出一个电极对24及其引线22的详细视图。托脚32由软柔性臂形成，所述软柔性臂被设计为保持电极对24离气囊壁为与气囊材料处于非接触关系中。软柔性臂还被设计为保持电极对24的尖端距气囊壁大致恒定的距离，例如1-2mm。同时，根据该实施例，细长引线22具有弯曲34和35以提供朝向气囊外部(远离中心轴)的预定偏置。
图3是示出瓣膜成形气囊14的部分截面图，瓣膜成形气囊14被放置在主动脉瓣52中并且之后提供特定处置以破坏或分离瓣叶52上的钙沉积56。电极对24从电液冲击治疗开始时已经由托脚保持距组织大致恒定的距离，例如大约1-2mm。当冲击波破坏钙时，瓣膜52中的开口慢慢变宽。尽管正更宽地打开瓣膜，但是受电极引线中的托脚32和弯曲34和35控制的电极对24与叶54的组织之间的距离仍保持大致恒定。
图4示出通过组合瓣膜成形气囊14和冲击波治疗扩张的瓣膜52的完全打开的开口60。导管和托脚中的偏置保持电极对距正被处置的瓣膜的组织大致恒定的距离。为简单起见，只示出两个电极。然而，在实际实践中，通常使用多达3-9个电极对。能够备选地或同时地激发电极对24(具有弧形成电压)。瓣膜52及其软化的瓣叶54(以及瓣膜尖瓣)上的钙现在破裂，使瓣膜更好地准备对TAVI(经导管主动脉瓣植入)瓣膜的放置。另外，自体瓣膜52可以在没有替换的情况下靠其自身起作用。
图5示出备选实施例。此处，导管110包括细长主体112和可膨胀气囊114，如同前面的实施例。然而此处可以是电极对的冲击波源120安装在具有篮臂或框架元件124的篮或框架结构122上。篮臂124可以由镍钛合金形成并且可以被设置为当通过冲击波软化并扩张正被处置的主动脉瓣狭窄时随着气囊114而扩张。
图6更详细地示出关于冲击波源120的镍钛合金臂124。此处可以看到，可以将臂124配置为具有凸缘或托脚132以在冲击波处置期间保持冲击波源120远离气囊和组织大致固定的距离。
如同前面的实施例，图6还示出导管112可以容纳导引线170。可以在导引线内腔172内接纳导引线170并且如前面所述地用于将导管引导到合适位置中。
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，并且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，其中该变化和修改落入本发明的真实精神和范围内。

Claims (20)

1.一种导管，包括：
细长主体；
由所述细长主体承载的可膨胀气囊，所述气囊具有内表面和外表面；
在所述可膨胀气囊内的至少一个冲击波源；以及
随动装置，其维持所述至少一个冲击波源距所述气囊的所述内表面大致固定的距离。
2.如权利要求1所述的导管，其中所述随动装置由在所述可膨胀气囊内的所述至少一个冲击波源承载。
3.如权利要求1所述的导管，其中所述至少一个冲击波源是弧发生器。
4.如权利要求3所述的导管，其中所述弧发生器包括电极对。
5.如权利要求4所述的导管，其中所述随动装置包括从所述电极对延伸的至少一个托脚。
6.如权利要求5所述的导管，其中所述托脚由弹性材料形成。
7.如权利要求5所述的导管，其中所述弧发生器包括细长引线，其中所述电极对由所述细长引线承载，并且其中在朝向所述可膨胀气囊的所述内表面的方向上偏置所述细长引线。
8.如权利要求7所述的导管，其中所述细长引线包括至少一个弯曲，所述至少一个弯曲朝向所述可膨胀气囊的所述内表面偏置所述细长引线。
9.如权利要求7所述的导管，还包括由所述细长引线承载的偏置构件，所述偏置构件朝向所述可膨胀气囊的所述内表面偏置所述细长引线。
10.如权利要求9所述的导管，其中所述偏置构件包括弹簧。
11.如权利要求1所述的导管，其中所述至少一个冲击波源包括弧发生器，其中所述随动装置包括由所述弧发生器承载的托脚，并且其中朝向所述可膨胀气囊的所述内表面偏置所述弧发生器。
12.如权利要求1所述的导管，还包括框架结构，所述框架结构承载所述至少一个冲击波源，其中所述框架结构随着所述可膨胀气囊的膨胀而扩张以维持所述至少一个冲击波源距所述气囊的所述内表面大致固定的距离。
13.如权利要求12所述的导管，其中所述框架结构包括邻近所述至少一个冲击波源的至少一个托脚以维持所述至少一个冲击波源距所述气囊的所述内表面大致固定的距离。
14.一种方法，包括：
提供导管，所述导管包括细长主体、由所述细长主体承载的可膨胀气囊以及在所述可膨胀气囊内的至少一个冲击波源，其中所述气囊具有内表面和外表面；
将所述导管插入到患者的静脉或动脉中并且邻近要处置的解剖结构放置所述气囊；
利用液体使所述气囊膨胀；
使所述冲击波源在所述气囊内提供冲击波，所述冲击波通过液体传播以处置所述解剖结构；以及
在由所述至少一个冲击波源提供所述冲击波的同时维持所述至少一个冲击波源距所述气囊的所述内表面大致固定的距离。
15.如权利要求14所述的方法，其中所述导管还包括由所述冲击发生器承载的随动件，并且其中所述维持步骤包括将所述随动件对着所述气囊的内壁偏置。
16.如权利要求14所述的方法，其中所述导管还包括框架结构，所述框架结构承载所述至少一个冲击波源，并且其中所述维持步骤包括利用所述可膨胀气囊的膨胀来扩张框架结构以维持所述至少一个冲击波源距所述气囊的所述内表面大致固定的距离。
17.一种导管，包括：
细长主体；
由所述细长主体承载的可膨胀气囊，所述气囊具有内表面和外表面；
承载放置在所述可膨胀气囊内的至少一个冲击波源的细长引线；以及
托脚，其被附接到所述引线并且被配置为远离所述气囊的所述内表面隔开所述冲击波源。
18.如权利要求17所述的导管，其中所述托脚由柔性材料形成。
19.如权利要求17所述的导管，其中所述至少一个冲击波源是弧发生器。
20.如权利要求19所述的导管，其中所述弧发生器包括电极对。
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US9220521B2 (en) 2015-12-29
CA2881184A1 (en) 2014-02-13
EP2879597B1 (en) 2016-09-21
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US20140163592A1 (en) 2014-06-12

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