CN102271748B - 冲击波瓣膜成形术导管系统 - Google Patents

冲击波瓣膜成形术导管系统 Download PDF

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CN102271748B
CN102271748B CN200980153687.XA CN200980153687A CN102271748B CN 102271748 B CN102271748 B CN 102271748B CN 200980153687 A CN200980153687 A CN 200980153687A CN 102271748 B CN102271748 B CN 102271748B
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丹尼尔·霍金斯
约翰·M·阿达姆斯
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    • 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
    • A61B17/22022—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 using electric discharge
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    • 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
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    • 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
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    • 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
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    • A—HUMAN NECESSITIES
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Abstract

一种瓣膜成形系统，其包括适于与瓣膜小叶邻近地放置的球囊。所述球囊可利用液体膨胀。所述系统进一步包括位于球囊内的产生冲击波的冲击波发生器。所述冲击波通过液体传播并且撞击瓣膜以除钙并打开瓣膜。

Description

冲击波瓣膜成形术导管系统
优先权要求
本申请要求于2008年11月5日提交的、共同未决的美国临时专利申请No.61/111,600的权益，该申请的全部内容通过引用并入于此。
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。医生将这种狭窄称之为主动脉狭窄。
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。也检查胆固醇水平，以确定需要药物治疗以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处理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，并且因此改善手术存活性。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％)。
本发明提供了一种用于狭窄或钙化的主动脉瓣的替代治疗系统。如接下来将看到的，这里描述的实施例对主动脉狭窄和钙化的主动脉瓣膜提供了比目前执行的主动脉瓣膜置换更能够为人所接受的治疗。本发明还提供了比目前的瓣膜成形术治疗更有效的治疗。
发明内容
在一个实施例中，一种瓣膜成形系统包括：适于与瓣膜小叶邻近地放置的球囊，所述球囊可利用液体膨胀；以及位于球囊中的冲击波发生器，其产生冲击波，该冲击波通过液体传播以撞击瓣膜。球囊可适于放置在瓣膜小叶的相对两侧或放置在瓣膜环内。
该系统可进一步包括伸长管。球囊可位于伸长管的末端。
球囊可包括第一球囊室和第二球囊室。第一球囊室和第二球囊室可彼此纵向间隔开。
伸长管可包括内腔。第一球囊室和第二球囊室与该伸长管的内腔流体连通。
冲击波发生器可包括位于第一球囊室中的第一冲击波源和位于第二球囊室中的第二冲击波源。第一冲击波源可包括第一电弧发生器，第二冲击波源可包括第二电弧发生器。电弧发生器可包括至少一个适于与电压脉冲发生器连接的电极。每个电弧发生器可包括适于与电压脉冲发生器连接的电极对。每个电极对可包括一对同轴布置的电极。
它们可进一步包括，该高压导管包括第一电弧发生器和第二电弧发生器的。第一电弧发生器和第二电弧发生器可彼此纵向间隔开，以用于分别容纳在第一球囊室和第二球囊室内。
如上所述，球囊可适于放置在瓣膜环内。为此，球囊可具有适于容纳在瓣膜环中的减小直径部分。
球囊可由柔性材料形成。
替代地，球囊可由非柔性材料形成。
根据另一个实施例，导管系统包括伸长的载体及由该伸长的载体携载的球囊。球囊被布置为在其中容纳使球囊膨胀的流体。所述系统进一步包括至少一个电弧发生器，所述电弧发生器包括至少一对位于球囊内的同轴布置的电极，所述电极在球囊内形成机械冲击波。
所述系统可进一步包括电缆，所述电缆包括中央导体及与内部导体绝缘的外部导电壳。同轴布置的电极的第一个电极可至少部分地由电缆的中央导体形成，而所述同轴布置的电极的第二个电极可至少部分地由电缆的外部导电壳形成。
根据又一个实施例，提供了用于处理瓣膜的瓣膜成形方法，所述瓣膜具有小叶和环，所述方法包括：与瓣膜小叶邻近地放置球囊；利用液体使球囊膨胀；以及在球囊中产生冲击波，该冲击波通过液体传播以用于撞击瓣膜小叶和瓣膜环。
可通过将球囊放置在瓣膜小叶的相对两侧来执行放置步骤。替代地，可通过将球囊放置在瓣膜环内来执行放置步骤。
附图说明
在随附权利要求书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，相似的附图标记指示相同的元件，并且其中：
图1为心脏的左心室、主动脉及主动脉瓣膜的剖视图，示出了由于钙化和纤维化组织的原因而减小的主动脉瓣膜开口区域以及变厚的瓣膜小叶；
图2为根据本发明的实施例的心脏主动脉瓣膜的剖视图，其中治疗球囊放置在主动脉瓣膜小叶的两侧；
图3为实现本发明的、连接至高压电源的双冲击波球囊的示意图；并且
图4为心脏的剖视图，示出了根据本发明的又一个实施例和方面的替代瓣膜成形术冲击波球囊。
具体实施方式
现在参考图1，其为心脏10的左心室12、主动脉14及主动脉瓣膜16的剖视图，该心脏10具有窄且钙化的主动脉瓣膜16。在此更特别地，可以看出窄且钙化的主动脉瓣膜16的开口17在尺寸上受到约束，并且瓣膜小叶18被纤维化组织和钙沉淀物加厚。加厚的小叶18及变小的瓣膜开口17限制来自心脏的血流，使心脏10产生超负荷工作以及较差的心输出量。如前面所述，目前的治疗包括瓣膜置换或试图用球囊张开瓣膜环。
图2为主动脉瓣膜16的剖视图，其中治疗球囊22放置在主动脉瓣膜小叶18的两侧。所述球囊22可由柔性或非柔性材料制成。如图2所示，所述球囊位于伸长管23的末端。治疗球囊22具有两个纵向间隔开的室24和室26，该两个室共享共同的管23的膨胀内腔25。替代地，球囊室24和球囊室26可不共享相同的膨胀流体路径。室24和室26纵向间隔开，使得室24定位在主动脉瓣膜小叶18的一侧而室26定位在主动脉瓣膜小叶18的另一侧。室24和室26例如通过盐水/对比剂混合物膨胀。室24和室26中的每一个均可包含电极(如接下来将看到的)，所述电极能够产生电弧以传送定时的冲击波。冲击波能够被同步以同时撞击小叶18的两侧，从而使破碎钙化沉淀物的效果最大。可以以如2008年6月13日提交的、共同未决申请No.61/061,170中所述的方式产生这种冲击波并与心脏10的R波同步，该申请整体并入于此。
图3为实现本发明的瓣膜成形系统11的示意图。系统11包括双冲击波球囊22。球囊22已容纳连接至高压电源30的高压导管32。该示意图示出了球囊室24在主动脉瓣膜16的小叶18的上方而球囊室26在主动脉瓣膜16的小叶18的下方的定位。如前所述，冲击波将冲击小叶18的相对两侧以更有效地破碎小叶18中的钙沉淀物。在这种布置中也将处理所述环。为此，高压导管32包括电极对34和36，所述电极对为分别放置在球囊22的室24和室26中的电极。更特别地，电极对34位于第一电缆的末端，并包括中央导体33及外部导电壳35。相似地，电极对34位于第二电缆的末端，并包括中央导体37及外部导电壳39。电源30的高压脉冲以如先前申请No.61/061,170中所述的方式施加到电极对34和36，以在球囊22的室24和室26中的流体内产生冲击波。所述冲击波撞击瓣膜小叶18和瓣膜环，以使瓣膜小叶18和环上的钙沉淀物和纤维化组织破碎从而打开主动脉瓣膜16。
图4示出了位于伸长管43末端的替代瓣膜成形术冲击波球囊42。球囊42放置在主动脉瓣膜16的环中。为此，球囊42具有减小的直径部分45，用于被容纳在瓣膜环内。球囊42中具有终止于电极对46的高压导管44。如先前的实施例中那样，电极对46可包括一对同轴布置的电极，其中中央导体可形成一个电极的至少一部分并且外部导电壳可形成另一个电极的至少一部分。所述导管44及其电极对46如前所述地提供冲击波。这种布置将对所述小叶18除钙。这不仅将对小叶18除钙，还将使主动脉瓣膜环变软并且扩张该瓣膜的直径。因此，球囊42提供了向瓣膜环直接施加膨胀压以改变所述环直径的附加优势。
尽管已示出并描述了本发明的具体实施方式，但可以进行修改，因此意欲覆盖落入本发明的真实精神和范围内的全部这种改变和修改。

Claims (43)

1.一种瓣膜成形系统，包括：
球囊，所述球囊适于与瓣膜的小叶邻近地放置，并且所述球囊能够利用液体膨胀；以及
位于所述球囊内的冲击波发生器，所述冲击波发生器产生冲击波，所述冲击波通过所述液体传播以撞击所述瓣膜，所述球囊被构造成在所述冲击波由所述冲击波发生器产生时保持完整无缺。
2.根据权利要求1所述的系统，其中所述球囊适于放置在瓣膜小叶的相对两侧。
3.根据权利要求2所述的系统，进一步包括伸长管，并且其中所述球囊位于所述伸长管的末端。
4.根据权利要求3所述的系统，其中所述球囊包括第一球囊室和第二球囊室，其中所述第一球囊室和所述第二球囊室彼此纵向间隔开。
5.根据权利要求4所述的系统，其中所述伸长管包括内腔，并且其中所述第一球囊室和所述第二球囊室与所述伸长管的内腔流体连通。
6.根据权利要求4所述的系统，其中所述冲击波发生器包括在所述第一球囊室内的第一冲击波源和在所述第二球囊室内的第二冲击波源。
7.根据权利要求6所述的系统，其中所述第一冲击波源包括第一电弧发生器，而所述第二冲击波源包括第二电弧发生器。
8.根据权利要求7所述的系统，其中每个所述电弧发生器包括至少一个适于与电压脉冲发生器连接的电极。
9.根据权利要求7所述的系统，其中每个所述电弧发生器包括适于与电压脉冲发生器连接的电极对。
10.根据权利要求9所述的系统，其中每个所述电极对包括一对同轴布置的电极。
11.根据权利要求7所述的系统，进一步包括高压导管，所述高压导管包括所述第一电弧发生器和所述第二电弧发生器，并且其中所述第一电弧发生器和所述第二电弧发生器彼此纵向间隔开，以被分别容纳在所述第一球囊室和所述第二球囊室内。
12.根据权利要求1所述的系统，其中所述球囊适于放置在瓣膜环内。
13.根据权利要求12所述的系统，进一步包括伸长管，并且其中所述球囊位于所述伸长管的末端。
14.根据权利要求13所述的系统，其中所述伸长管包括内腔，并且其中所述球囊与所述伸长管的内腔流体连通。
15.根据权利要求14所述的系统，其中所述冲击波发生器包括电弧发生器。
16.根据权利要求15所述的系统，进一步包括高压导管，所述高压导管包括所述电弧发生器，并且所述高压导管布置为沿着球囊伸长管在所述内腔内延伸。
17.根据权利要求15所述的系统，其中所述电弧发生器包括至少一个适于与电压脉冲发生器连接的电极。
18.根据权利要求15所述的系统，其中所述电弧发生器包括电极对。
19.根据权利要求18所述的系统，其中所述电极对包括一对同轴布置的电极。
20.根据权利要求12所述的系统，其中所述球囊具有适于容纳在瓣膜环内的减小直径部分。
21.根据权利要求1所述的系统，其中所述球囊由柔性材料形成。
22.根据权利要求1所述的系统，其中所述球囊由非柔性材料形成。
23.一种用于处理瓣膜的瓣膜成形系统，所述瓣膜具有小叶和环，所述瓣膜成形系统包括：
球囊，所述球囊适于放置在所述瓣膜的所述小叶的相对两侧，并且所述球囊能够利用液体膨胀；以及
位于所述球囊内的冲击波发生器，所述冲击波发生器产生冲击波，所述冲击波通过所述液体传播以撞击瓣膜小叶和瓣膜环，所述球囊被构造成在所述冲击波由所述冲击波发生器产生时保持完整无缺。
24.根据权利要求23所述的系统，进一步包括伸长管，并且其中所述球囊位于所述伸长管的末端。
25.根据权利要求24所述的系统，其中所述球囊包括第一球囊室和第二球囊室，其中所述第一球囊室和所述第二球囊室彼此纵向间隔开。
26.根据权利要求25所述的系统，其中所述伸长管包括内腔，并且其中所述第一球囊室和所述第二球囊室与所述伸长管的内腔流体连通。
27.根据权利要求25所述的系统，其中所述冲击波发生器包括在所述第一球囊室内的第一冲击波源和在所述第二球囊室内的第二冲击波源。
28.根据权利要求27所述的系统，其中所述第一冲击波源包括第一电弧发生器，而所述第二冲击波源包括第二电弧发生器。
29.根据权利要求28所述的系统，其中每个所述电弧发生器包括至少一个适于与电压脉冲发生器连接的电极。
30.根据权利要求28所述的系统，其中每个所述电弧发生器包括适于与电压脉冲发生器连接的电极对。
31.根据权利要求30所述的系统，其中每个所述电极对包括一对同轴布置的电极。
32.根据权利要求28所述的系统，进一步包括高压导管，所述高压导管包括所述第一电弧发生器和所述第二电弧发生器，并且其中所述第一电弧发生器和所述第二电弧发生器彼此纵向间隔开，以被分别容纳在所述第一球囊室和所述第二球囊室内。
33.一种用于处理瓣膜的瓣膜成形系统，所述瓣膜具有小叶和环，所述瓣膜成形系统包括：
球囊，所述球囊适于与所述瓣膜的小叶邻近地放置在瓣膜环内，并且所述球囊能够利用液体膨胀；以及
位于所述球囊内的冲击波发生器，所述冲击波发生器产生冲击波，所述冲击波通过所述液体传播以撞击瓣膜小叶和瓣膜环，所述球囊被构造成在所述冲击波由所述冲击波发生器产生时保持完整无缺。
34.根据权利要求33所述的系统，进一步包括伸长管，并且其中所述球囊位于所述伸长管的末端。
35.根据权利要求34所述的系统，其中所述伸长管包括内腔，并且其中所述球囊与所述伸长管的内腔流体连通。
36.根据权利要求35所述的系统，其中所述冲击波发生器包括电弧发生器。
37.根据权利要求36所述的系统，进一步包括高压导管，所述高压导管包括所述电弧发生器，并且所述高压导管布置为沿着球囊伸长管在所述内腔内延伸。
38.根据权利要求36所述的系统，其中所述电弧发生器包括至少一个适于与电压脉冲发生器连接的电极。
39.根据权利要求36所述的系统，其中所述电弧发生器包括电极对。
40.根据权利要求39所述的系统，其中所述电极对包括一对同轴布置的电极。
41.根据权利要求33所述的系统，其中所述球囊具有适于容纳在瓣膜环内的减小直径部分。
42.一种导管系统，包括：
伸长的载体；
球囊，所述球囊由所述伸长的载体携载，并且所述球囊被布置为在其中容纳使所述球囊膨胀的流体；以及
至少一个电弧发生器，所述至少一个电弧发生器包括至少一对位于球囊内的同轴布置的电极，所述电极在所述球囊内形成机械冲击波，所述球囊被构造成在所述冲击波由所述电极产生时保持完整无缺。
43.根据权利要求42所述的系统，进一步包括电缆，所述电缆包括中央导体和与内部导体绝缘的外部导电壳，其中所述同轴布置的电极中的第一个电极至少部分地由所述电缆的所述中央导体形成，并且其中所述同轴布置的电极中的第二个电极至少部分地由所述电缆的所述外部导电壳形成。
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US20210338258A1 (en) 2021-11-04
CA2779600C (en) 2018-04-10
JP6246277B2 (ja) 2017-12-13
JP2016195821A (ja) 2016-11-24
JP6081510B2 (ja) 2017-02-15
US9044619B2 (en) 2015-06-02
WO2010054048A3 (en) 2010-09-02
JP6029828B2 (ja) 2016-11-24
EP2362798A2 (en) 2011-09-07
US20150238209A1 (en) 2015-08-27
EP2362798B1 (en) 2014-04-09
US9421025B2 (en) 2016-08-23
US20160324534A1 (en) 2016-11-10
US11000299B2 (en) 2021-05-11
CA2779600A1 (en) 2010-05-14
US20190069916A1 (en) 2019-03-07
US9044618B2 (en) 2015-06-02
JP2015128635A (ja) 2015-07-16
US20110295227A1 (en) 2011-12-01
AU2009313507B2 (en) 2014-11-27
JP2012508042A (ja) 2012-04-05
AU2009313507A1 (en) 2010-05-14
EP2362798A4 (en) 2013-04-03
WO2010054048A2 (en) 2010-05-14
CN102271748A (zh) 2011-12-07
US20100114020A1 (en) 2010-05-06

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