CN103635226B - 用于建立和保持房内压力释放孔的装置 - Google Patents
用于建立和保持房内压力释放孔的装置 Download PDFInfo
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- CN103635226B CN103635226B CN201280017589.5A CN201280017589A CN103635226B CN 103635226 B CN103635226 B CN 103635226B CN 201280017589 A CN201280017589 A CN 201280017589A CN 103635226 B CN103635226 B CN 103635226B
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- perforate
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- atrial septum
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Abstract
本发明涉及一方法和一器械,用于通过使哺乳动物左右心房升高的压力正常化以治疗心力衰竭。本发明包括在房间隔建立并保持一开孔的方法。还公开了形成一开孔并保持该开孔的工具。使用本文描述的技术和工具延长一房内压力释放孔的畅通时间。
Description
技术领域
本文公开的内容涉及到治疗心力衰竭的方法和器械,特别是通过在心腔内建立一房内压力释放孔降低心房内升高的血压,从而治疗心力衰竭的方法和器械。此外,本文公开的内容还涉及到用于保持或延长房内压力释放孔畅通的方法和器械。
背景技术
全球有数以百万计的患者受到心力衰竭的困扰。心力衰竭即包括左心衰竭也包括右心衰竭或两者皆有。左心衰竭会导致肺静脉血压升高,从而产生呼吸问题,包括呼吸急促和运动障碍。有多重原因可导致左心衰竭,包括心脏瓣膜疾病、左心室收缩性衰竭和左心室舒张性衰竭。这些症状的不良临床结果是相似的,心力衰竭导致左心房和肺静脉中的压力升高,妨碍含氧血液的正常流动。因此,需要一种疗法以消除体内肺动脉压力升高的不良影响。
心力衰竭被进一步分为收缩性心力衰竭和舒张性心力衰竭。舒张性心力衰竭是指在无重大心脏瓣膜疾病症状并且左心室收缩性功能健全的情况下的心力衰竭。更一般地来说,舒张性心力衰竭是指心室无法充分舒张使血液流入,从而导致心脏搏出量减少。现在,治疗舒张性心力衰竭患者的方法很少。因此,存在对治疗因舒张性心力衰竭导致的肺静脉压力升高的方法和器械的需求。
已公开了一些降低肺静脉压力的技术,但这些技术都存在严重缺陷。例如,授予Keren等人的美国专利号为09/839,643的专利揭示了使用复杂的带有血管内支架阀的心房内压力释放分流器。这种方法存在一系列不足。首先,该拟定的治疗方法需植入复杂的植入器械,从而增加了多种临床并发症和不良事件的风险。植入物部分存在于左右心室中,造成产生血栓并且在左右循环中释放栓塞的风险。
在左循环中释放栓塞可能导致心肌梗死或中风。此外,阀门装置需要活动部件,这将增加长期植入材料的疲劳和器械断裂的风险。器械断裂可能转而导致植入物全部或部分栓塞。此外,纳入分流器的阀门有发生灵敏性故障的可能,这有可能导致左心室负载快速增加。可以想象,患者将经受由该治疗用途的分流器引起的严重突发性循环压力过载,并可能导致严重的并发症。因此,存在对治疗因心力衰竭导致的肺静脉压力升高的简单有效方法的需求。
发明内容
在一般情况下,本文公开的内容涉及通过降低左心房和肺静脉压力以治疗心力衰竭的方法和器械,包括在房间隔建立一房内压力释放孔。此外,本文公开的方法和器械为该房内压力释放孔附近的组织提供了治疗方法,以保持该开孔的长期畅通。
该方法和器械对于治疗左心衰竭症状特别有效,并且通过降低左心房和肺静脉压力,对于治疗舒张性心力衰竭尤其有效。
本发明涉及治疗心力衰竭的导管器械。该导管器械包括具有至少一管腔的一外鞘套。该器械还包括用于穿透在患者心脏的第一高压心腔和第二低压心腔之间的房间隔的一穿孔器,通过在房间隔建立一开孔并且使用一扩张器撑开该开孔至实质上的第二明显扩大开孔,从而在房间隔上建立一房内压力释放孔。该器械还包括一种适于治疗大体上在房内压力释放孔周围的房间隔的机制,以避免该间隔上第二明显扩大开孔的自愈功能,该第二明显扩大开孔的大小足以使血液从第一高压心腔经过该房内压力释放孔流向第二低压心腔。这样既降低了心房和肺静脉的压力,又不用在房间隔内植入机械器械。
本文公开的内容还描述了用于使心腔内升高的血压恢复正常的方法。该方法包括以下步骤:穿透在患者心脏的第一高压心腔和第二低压心腔之间的房间隔以在房间隔中建立第一开孔;将该第一开孔扩张至第二明显扩大开孔,其大小足以建立一房内压力释放孔;为围绕该房内压力释放孔的房间隔提供至少一种治疗方法,其中所述第二明显扩大开孔的大小足以使血液从第一高压心腔经过该房内压力释放孔流入第二低压心腔,从而降低心房和肺静脉压力。
根据本文公开的内容还包括另一种用于使患者心腔内升高的血压恢复正常的方法。该方法的步骤包括:在患者心脏的第一高压心腔和第二低压心腔之间的房间隔上穿孔,以在房间隔上建立第一开孔。该方法的步骤还包括:将该第一开孔扩张至第二明显扩大开孔,其大小足以建立一房内压力释放孔,摘除该患者房间隔上被分开的组织,并为围绕该房内压力释放孔的房间隔提供至少一种治疗方法,其中所述第二明显扩大开孔的大小足以使血液从第一高压心腔经过该房内压力释放孔流入第二低压心腔,而无需在该房间隔中植入血管内支架或阀门。
在本文公开内容的一个实施例中,该房内压力释放孔建立在卵圆窝附近间隔区域中的房间隔上。该房内压力释放孔被配置用于使治疗量的血液在左、右心房间流动,以减少与升高的左心房和肺静脉压力有关的负面临床效果。所述方法延迟围绕该房内压力释放孔的间隔组织的愈伤反应,这种反应会堵塞该开孔。
在本文公开内容的一些示例性实施例中,将第一直径的开孔扩张至实质上的第二大直径的开孔,以建立一房内压力释放孔,这项工作是使用扩张导管的圆锥形远端完成的。
在本文公开的内容的一些实施例中,将第一直径的开孔扩张至实质上的第二大直径的开孔,以建立一房内压力释放孔,这项工作是使用气囊导管完成的。
在本文公开内容的一些实施例中,可对房内压力释放孔施加一种治疗方法,以干扰、减缓或降低人体组织的愈合能力并阻止该房内压力释放孔得到治疗。这种治疗方法可能包括一种能量输送的方式,例如将射频能量、超声波能量、激光能量、可见光能量或紫外线光能量输送到该房内压力释放孔附近的组织。
在一些附加实施例中,这种治疗方法可能向该组织传递热能或移除热能,例如通过蒸汽、使用其他方式产生的热量加热该组织,或通过低温冷却传热介质冷冻该组织。
还有一些实施例中,该治疗方法从物理上或机械上研磨该房内压力释放孔附近的组织,因此包括在该开孔附近形成增厚的瘢痕组织,并减缓身体的愈伤反应。
在另一些实施例中,该治疗方法通过向该房内压力释放孔附近组织分泌固定剂或粘接剂从而固定或粘合该组织。还有一些实施例中,该治疗方法使用设计的导管摘除该房内压力释放孔附近的组织,该方法将该组织处于酒精作用下,从而限制身体的愈合和该房内压力释放孔被阻塞。
在本文公开内容的一些附加实施例中,使用导丝或其他合适的器械在房间隔穿孔,从而建立房内压力释放孔。然后,在该房间隔上新建立的第一直径的开孔中使用专门设计的气囊导管。该气囊至少涂有一种抗增生或免疫抑制药物。然后使该气囊膨胀,从而同时扩张该开孔,建立房内压力释放孔,并使药用涂层附着在该房内压力释放孔附近的组织上。这样就干扰了身体正常的愈伤反应,并增加了该房内压力释放孔保持长期畅通的时间。
在另一些实施例中,在患者组织内表面涂敷药物。这种方法使用外表面涂有药物的气囊。在一种变体方法中,药物涂敷在该气囊外表面的吸收垫上。使用一个鞘将该气囊部署到患者体内,并且使该气囊膨胀,以使药物涂敷到该患者的组织内表面。在一实施例中,该内表面为房间隔内的一开孔。在一实施例中,该药物为西罗莫司、紫杉醇、佐他莫司、依维莫司、硝酸银、嘧啶、氨甲喋呤、硫唑嘌呤、放线菌素、福尔马林、甲醛和乙醇。
此处公开的工具、装置和方法具有很多优点。优点之一是通过降低心脏的一个心腔的高压和肺静脉压力从而减轻心力衰竭。此处公开的房内压力释放孔不会留下任何复杂、昂贵或有潜在危害的植入物。此处描述的疗法通过阻止或实质上地延迟房内压力释放孔附近的房间隔组织的自愈过程,从而延长或保持该房内压力释放孔的畅通。此外,此处描述的方法和技术建立了具有自动防止故障的房内压力释放孔,该孔对故障反应不灵敏,并且经过一段延长的或显著的临床时间后才会堵塞。采用此处描述的方法和技术建立的房内压力释放孔可以使血液从左心房流到右心房,从而降低左心房和肺静脉压力。此处描述的这些实施例中,通过对房内压力释放孔附近的组织施加治疗,从而防止或实质上减缓愈伤反应而取得这种效果,愈伤反应通常会关闭该房内压力释放孔。
结合下面对当前最佳实施例的详细描述以及附图(未按比例描绘),将更加明显地显示出本文公开内容的上述和其他功能和优点。详细描述和附图只是本文公开内容的图示说明,并未限制附加的权利要求和其等价物的范围。一般的专业人士可根据具体的详细说明制作和使用本发明的器械并实践本发明的方法。但应当理解,一般的专业人士可以对本发明做出替换和补充,这些替换和补充仍属于此处公开的本发明的特征。
附图说明
图1是植入患者心脏内器械的侧面截面图。
图2A是一实施例的侧视图,该实施例描述了采用细导丝电极提供能量的一导管。
图2B是一实施例的侧视图,该实施例描述了采用一系列射频电极提供能量的一导管。
图2C是一实施例的侧视图,该实施例描述了采用两只半圆形电极以承载双极射频电极能量的一导管。
图2D是一实施例的侧视图,该实施例描述了采用压电式超声波感应器阵列提供能量的一导管。
图2E是一实施例的侧视图,该实施例描述了采用凹形压电式超声波感应器阵列提供能量的一导管。
图2F是一实施例的侧视图,该实施例描述了采用环形腔携带传热流体以提供能量的一导管。
图3是一实施例的侧面截面图,该实施例显示了植入人体心脏的带有一扩张气囊的导管器械。
图4A是一实施例的截面图,该实施例描述了涂有药物层的一膨胀式圆柱形扩张气囊。
图4B是一实施例的截面图,该实施例描述了一扩张气囊,该气囊具有一光纤,该光纤用于传递所需密度的可见光能量。
图4C是一实施例的截面图,该实施例描述了一扩张气囊,该气囊具有一光纤,该光纤远端覆盖有用于传递可见光能量的反射涂层。
图4D是一实施例的侧视图,该实施例描述了采用多个压电式超声波感应器阵列提供超声波能量的一扩张气囊。
图4E是一实施例的截面图,该实施例描述了一扩张气囊,该气囊具有两条传递能量的流体通道。
图5是一实施例的截面图,该实施例描述了配置用于研磨或刮掉房内压力释放孔周围的间隔的一导管。
图6A-6B是截面图的一部分,该图描述了另一种在患者间隔壁上形成内部开孔的方法。
图7A-7B描述了另一种在患者间隔壁上形成足以释放心房内压力的开孔的方法。
图8描述了用于摘除切下的间隔壁组织的抓手。
具体实施方式
参考图1,该图描述了治疗心力衰竭的一实施例。图1显示了房间隔100,该间隔被导丝102穿透,从而建立了第一直径的开孔并进一步在扩张工具106的帮助下扩张为实质上的第二大直径的开孔。该扩张工具是扩张导管104的圆锥形远端106,被配置用于让使用者可以扩张由导丝102建立的第一直径的开孔。导丝102和扩张导管104从右心房108延伸入左心房110。扩张导管104具有治疗方法112,用于向被扩张工具106扩大的第一直径开孔附近的间隔组织传递能量。在图1中,传递能量的工具被描绘成扩张导管104上的交叉阴影区域。传递能量的治疗方法112可被用于摘除由扩张工具106建立的第二大直径开孔附近的组织,其目的是改善由导丝102和扩张工具106建立的房内压力释放孔的长期畅通情况。
图1中的交叉导丝102可采用现有的用于导管治疗过程的任何刚性导丝,或为该过程定制的导丝。导丝102可包括一锋利的尖端,以便更好地穿透间隔100。导丝102可由不锈钢、镍钛合金或任何其他适合材料制成。穿透间隔100后,可从体内收回导丝102,也可将该导丝留在体内,以便将后续使用的器械和导管推进到体内。此外,导丝102可具有一弯曲的远端部分,以防使用者意外地刺穿左心房壁110。在一实施例中,导丝钩102是直径9毫米(.035英寸)的镍钛合金J形弯曲导丝。在另一实施例中,导丝钩102可能类似用于治疗完全心肌梗塞的导丝。设计、制造和使用用于穿透组织和病灶的导丝钩已被专业人士所熟知。
图1中的扩张导管104可采用多种方法并且以任何适合的生物相容性材料制造。简单的扩张导管104可采用低密度聚乙烯(LDPE)、高密度聚乙烯(HDPE)或氟化乙烯聚丙烯(FEP)制造,并可具备一热定型或超模压的圆锥形尖端。另一种适合的扩张导管104可能包括具有专门设计的圆锥形尖端106的由改性尼龙(PEBAX)或尼龙编织的轴。该扩张导管的横截面通常为圆形,但可能采用脊和纹理,通过在该脊附近的组织形成局部应力集中,以更加有效地扩张间隔。此外,扩张导管104的圆锥形远端部分106可能具备多种剪切手段,例如金属小刀片,或锋利的塑料突出物,以便更加有效地扩张房间隔100。扩张导管100的外径(OD)设计,使其在间隔100上形成的开孔大小足以使足够的血液从该开孔流过,以实质上地降低肺静脉和左心房血压。在一些实施例中,扩张导管104的外鞘直径大致在3毫米至5毫米之间。扩张导管104可被配置为超出导丝102,并因此可至少包含一个导丝管腔。额外的空腔可具有额外的功能,包括用于次级治疗器械和注入生物相容性染料的空腔。此外,该扩张器可具有停止作用,以防使用者将该扩张导管过度推进至左心房110内,导致能量输送工具112不再与心房内间隔100的组织相接触。
还是参考图1,该扩张导管从下腔静脉中的进入点开始,经过下腔静脉114扩张到右心房108。在一些代替实施例中,可采用其他方法使扩张导管104进入房间隔100,包括从颈内静脉开始并经过上腔静脉116。此外,可通过其他方法进入房间隔100,包括采用微创手术和通过体内其他主要血管。
现在探讨图2A至2F,这些图描述了一系列能量输送方法的示例。图2A显示了交叉导丝102,该导丝从扩展导管104上伸出,具有一圆锥形远端106。图示的细导丝电极200螺旋缠绕在位于圆锥形尖端102近端的扩张导管104的轴上。电极200是迂回扭曲缠绕的,从而尽量增加了与组织的接触。电极200被妥善连接到一外部电源,如直流电源。当电源使电流通过电极200时,该导丝在电阻作用下被加热。电极200与人体绝缘,以防电流产生不良反应或在人体内形成短路。小心控制流过电极200的电流即可控制该导管轴的表面温度。该电路可包括用于度量或监控温度的方法,还可包括紧急断路器,以便在温度过高时断开电路。热能经过该扩张器传递到组织上,以便摘除或破坏房内压力释放孔周围的组织。烧蚀房内压力释放孔附近的组织可阻碍愈合过程,并延长房内压力释放孔的畅通时间。
现在探讨图2B,该图描绘了一扩张导管104,该导管具有一延长轴和一圆锥形尖端106。该轴表面暴露有一系列射频(RF)电极202,紧靠圆锥形尖端106的近端。电极202被设计用于承载单级射频能量,并将该能量输送到组织。可采用合适的射频发生器提供射频能量,该发生器在医院和导管实验室中很常见。可使用穿过导管长度的绝缘导丝将该电极和射频能量相连。可在患者身体上接入一接地垫,作为组织被明显烧蚀后散开电流的安全装置。因此,射频电极阵列202表现了一种为了烧蚀组织而向房内压力释放孔周围的组织传递能量的方法。
现在探讨图2C,该图描绘了一扩张导管104,该导管具有一延长轴和一圆锥形尖端106。图中显示了两只半圆形射频电极204、206。电极204、206被设计用于承载双级射频能量,并将该能量输送到组织。例如,射频电极206可代表返回电极,射频能量从电极204开始传递,经过围绕扩张导管104的组织并传导回射频电极206,从而完成该回路。电极204、206可连接到一外部射频发生器,其方式非常类似图2B所示。使用射频能量治疗组织已被专业人士所熟知。例如,在电生理学过程中采用射频能量治疗房颤。
现在探讨图2D,该图描绘了一扩张导管104,该导管具有用于治疗组织的一能量输送工具208。图2D所示能量输送工具可表现为两个压电式超声波传感器阵列210、212。根据需要,可使用额外的压电式超声波传感器阵列,例如:可在扩张导管104周围放置四个这种阵列。超声波传感器210、212被配置用于在向这些传感器供应适当的项控交流电流时发射高频聚焦超声波能量。可通过将每个传感器阵列连接到电缆管214、216而实现这点,电缆管转而被连接到一外部电源。电缆管214、216可包括多条独立的绝缘导丝。每条导丝被配置用于向该传感器阵列的不同部分传递交流电流。每条导丝中的电流都由该外部电源仔细控制,从而使发射穿过阵列的超声波能量相位正确,以便将所有信号都导向围绕扩张导管104的组织上的一聚焦区域。
还是参考图2D,该相位传感器阵列以一种已被专业人士所熟知的方式处理波干扰。由扩张导管104发射的高密度聚焦超声波通过这种方式在超声波阵列的焦点产生大量热能。可围绕轴将阵列大致排列成圆形以发射这种聚焦超声波,从而烧蚀扩张导管104附近的组织。通过这种方式,超声波阵列代表了一种治疗组织的方法,其目的是为了减缓或防止人体的自愈过程。
现在探讨图2E,图示为用于建立房内压力释放孔的扩张导管104,该导管具有用于治疗组织的一能量治疗工具208。该能量输送工具表现为两个或多个压电式超声波传感器阵列210、212。虽然图示为两个传感器阵列210、212,但可采用任意数量的这种阵列以产生类似效果。对照图2D,图2E所示传感器阵列的形状像一面凹透镜,使该传感器可自然地发射聚焦超声波能量。图2E所示传感器阵列因此无需将阵列元件分为不同相位即可发射聚焦的超声波能量。传感器阵列电气性连接到电缆管214、216,电缆管转而连接到一外部电源。电源以这种方式产生交流电流,并最终通过电缆管214、216为超声波阵列210、212供电。发射的聚焦超声波能量加热阵列焦点附近的组织。图2E所示超声波阵列以这种方式表现了一种破坏或烧蚀组织的方法,其目的是为了防止或延缓身体的自然愈合过程,否则该过程将在一段时间后使房内压力释放孔关闭。
现在探讨图2F,图示的扩张导管104可用于建立一传递工具208,用于治疗房内压力释放孔周围的组织。该能量输送工具表现为位于扩张导管104内部的一环形腔218。环形腔218连接到一入口管腔220和一出口管腔222。传热流体从入口管腔220泵入环形腔218,流体在此处与周围转换热能或从周围吸收热能。流体随后从出口管腔222泵出。传热流体以这种方式在扩张导管104的环形腔218中实现循环。该传热流体可为多种流体材料,包括非常冷或非常热的生理盐水、蒸汽或低温流体。此外,几乎任何合适的流体或气体可在正确的温度下被泵送,以治疗该组织。在一些实施例中,该传热流体为生理盐水,并在55-65摄氏度下被泵送通过该扩张导管。在另一些实施例中,生理盐水在-10摄氏度左右被泵送通过该导管。
图2F所示扩张导管104的环形腔218可被具有极高热导率的材料围绕,例如不锈钢或其他金属。以这种方式被泵送通过环形腔218的热或冷流体可以冷却或加热扩张导管104周围的组织,以烧蚀或破坏该组织。因此,具有用于循环传热流体的环形腔218的扩张导管104代表了一种治疗方式,用于治疗房内压力释放孔附近的组织,以减缓或防止身体的自愈过程。
图2A至2F所示能量输送方式并非打算作为各种用于治疗组织的能量输送方式的详细清单。除了所述能量输送方式以外,还可使用许多其他能量输送机制。在另一些实施例中,例如,可通过该导管内的光纤输送高密度非聚焦光,并导向至该房内压力释放孔周围的组织。在另一些实施例中,一束聚焦光,比如激光,可被导向至该组织。还是在另一些实施例中,可运用其他形式的电磁能量治疗该组织,例如紫外线或微波辐射线。还是在另一些实施例中,可混合使用上述任何方法用于治疗该房内压力释放孔周围的组织。
在图2A至2F所示实施例中,描述了多级电极或传感器,应该能够理解,可使用任何合适数量的电极或传感器。在一些实施例中,例如,可在该扩张导管周围布置两只、三只、四只、五只或更多射频电极,以治疗该组织。
在一些实施例中,该扩张导管可能采用任何能量输送方式。在这些实施例中,可使用一类似该扩张导管的次级导管,但无需圆锥形扩张尖端。该次级治疗导管可使用此处公开的多种能量输送方式中的任何一种,以治疗房内压力释放孔周围的组织。以这种方式,扩张房间隔开孔和治疗房内压力释放孔可成为使用不同的导管完成的不同任务,但仍属于图2A至2F所描绘的公开内容的范围内。
现在探讨图3,图示为额外的实施例。图3所示为一扩张气囊302,该气囊已被推进到房间隔100并膨胀。该气囊可被配置为沿着导丝102推动,已通过本文前面讨论的常规跨间隔导丝运载方式使该导丝穿透房间隔。可能已使用一简单的圆锥形尖端扩张导管将房间隔100上的开孔预先扩张,以便使气囊302进入房间隔100更加容易。气囊302被设计用于扩张房间隔100上的开孔,从而建立或扩大一房内压力释放孔至治疗所需的大小。在一些实施例中,气囊302可将房间隔100上的开孔扩张至4毫米至8毫米。纳入气囊302是治疗房内压力释放孔周围组织的一种可选治疗方法。在一些实施例中,该疗法可包括一种向组织输送能量的方式。在另一些实施例中,该疗法包括向该组织输送一种或组合的药物。
图3中的扩张气囊302可采用沙漏形状,其中间直径小于两头的。另一种选择是,气囊302可为一简单的圆筒,或椭圆形或任何其他合适的形状。气囊302可在其表面选装应力集中或剪切元件,以便更加容易地扩张房间隔100上的开孔。气囊302可为顺应性的或非顺应性的。该气囊导管可包括射线不透性物质标记,以便于使用者可将气囊302正确地放置在房间隔100上,从而在扩张房间隔100的同时使气囊302膨胀。另一种选择是,气囊302的设计使之能让整个左心房膨胀,并随后被使用者收回,从而使气囊302就位并扩张房间隔100。制造气囊和使气囊膨胀的方法在本领域中已很成熟。
还是参考图3,图中所示气囊导管正沿着下腔静脉114被推进到房间隔100。在一些代替实施例中,可采用其他方法使扩张气囊进入房间隔,包括从颈内静脉开始并经过上腔静脉116。此外,可通过其他方法进入房间隔,包括采用微创手术和通过体内其他主要血管。
现在探讨图4A-4E,图中所示扩张气囊具有一系列示例性次级治疗方法。图4A所示为一膨胀的圆柱形扩张气囊402的截面图。扩张气囊402沿着交叉导丝102穿过房间隔100。箭头404描述了用于使气囊膨胀的流体压力。气囊402涂有药物层405,此药物用于减缓身体的愈合过程,比如抗增生或免疫抑制药物。在一些实施例中,该药用涂层可为以下药物的一种或其组合:紫杉醇、依维莫司、西罗莫司(雷帕霉素)、佐他莫司、替西罗莫司、阿霉素、环磷酰胺或类似化合物。也可用适合的涂药器以任何其他正确的方式运用这些药物。
在下面所述实施例中,该气囊可具有一中心管腔,如图4A所示,用于沿导丝钩102部署该气囊。在该中心管腔上的一个或多个点或该气囊的其他部位可包括一回声或不透射线的功能,以定位该气囊相对于该房间隔及其上的第一开孔和第二明显扩大开孔的位置。如上所述,该气囊外表面的一部分可涂上药物层,这样,当该气囊被膨胀后,其外表面和其上的药物就被压到该房间隔的开孔上。部署该气囊时,通常沿着鞘104内的导丝钩下拉该气囊。在一些实施例中,将该气囊部署于外鞘套104内的保护鞘(未显示)中。该保护鞘用于保护该气囊及其外表面的药物,直到该待膨胀的气囊就位。此时,可准备膨胀该气囊了。使气囊膨胀将扩大房间隔上的开孔并使药物涂敷到现已暴露的房间隔(开孔)内表面,该开孔可能是由该气囊建立的。另一种选择是,房间隔上被扩大的开孔可由下述的另一种方式形成,同时使用气囊涂敷药物。诸如抗增生或免疫抑制之类的药物可用于减缓身体的愈合过程。药物的例子包括:西罗莫司、紫杉醇、佐他莫司、依维莫司、硝酸银、嘧啶、氨甲喋呤、硫唑嘌呤、放线菌素、福尔马林、甲醛和乙醇。
还是在一些其他实施例中,该涂层包含类似在短距离放射治疗中使用的一放射源。在一些实施例中,为了尽量增大气囊402与药用涂层405的接触面积,可使该气囊采用图4A所示形状,并且该房内压力释放孔由气囊402建立。在一些实施例中,具有药用涂层405的气囊402还可具有肋条、突起或其他有切口的元件,以进一步增加被该涂层治疗的有效表面积。在一些实施例中,该气囊在房间隔100中膨胀,并随后拉回或推进至远端附近或只是被旋转,以促进药用涂层405与房内压力释放孔周围的组织的粘贴。
图4B所示的扩张气囊406被配置用于通过扩张采用传统方法建立在房间隔100上的一开孔,从而建立一房内压力孔。在图4B中所示气囊406具有一塞子408,用于封闭远端,并因此不能沿导丝移动。如上述公开的内容,并且在一些代替实施例中,该扩张气囊还可被配置为具有一中央通过管腔,以便沿着导丝移动。图示气囊导管嵌套在一可选的输送鞘410内,该鞘用于使该器械与房间隔上开孔保持正确的相对位置。
气囊406包括一能量输送工具,其中纳入一灵活的光纤412,可使用该光纤以所需强度传导可见光。该可见光在图4B中以虚线414表示。光纤412被置于一中央通道中,该通道未连接用于输送膨胀流体的环形通道416。在一些实施例中,该膨胀流体采用具有极高透光率的物质。在一些实施例中,该膨胀流体为蒸馏水、非电离水或气体,例如空气或氮气。气囊406中的光纤412发射的光能大体上沿该治疗器械的轴向。一面三维曲面镜418被放置在与光纤412一致的方向上。曲面镜418被配置用于径向反射光能。曲面镜418还被配置用作透镜,将光聚焦到轴向的一薄膜上。因此,该光源和曲面镜418将大量光能传导至房间隔100周围的组织上,产生可观的热能,从而烧蚀或破坏房内压力释放孔附近的组织。
图4C所示的扩张气囊406被配置用于通过扩张采用传统方法建立在房间隔100上的一开孔,从而建立一房内压力孔。气囊406类似图4B所示气囊,除了该气囊的远端420被反射涂层422所覆盖。气囊406被进一步配置为当其完全膨胀时,其远端的形状像一面凹透镜。透镜形状结合反射涂层422,使扩张气囊406成为一反射和聚焦光线的工具。光线由一光学导管424提供,该导管可以是一单独的光纤或一光纤电缆。光经过的路径在图中以一系列曲线426表示,其大致类似于该光纤所发光波的形状。可以说该光线离开该光纤后继续向反射性远端传播,在该远端,光线被汇聚并以一定角度通向房内压力释放孔周围组织。光线被气囊406的远端反射后,可进一步被描述为像一空心圆锥并且强度更大。图4C所示扩张气囊406以这种方式代表了一种方法,通过将高强度光聚焦在房内压力释放孔附近的组织上,从而烧蚀该组织。
现在回到图4D,图示的扩张气囊406已膨胀并扩张房间隔100的开孔。至于在其他实施例中,可采用本文所述并且已被专业人士所熟知的传统方法建立房间隔100上的初始穿孔。此外,可提前使用一简单的扩张导管插入房间隔100,以便预先扩张该房间隔100上的初始穿孔并实施治疗。气囊406被配置为可在一交叉导丝102上移动,虽然在一些代替实施例中,没有交叉导丝102的辅助气囊406也可移动。
图4D所示气囊中纳入了多个压电式超声波传感器阵列428、429,其类似于上面讨论并如图2E所示传感器阵列。传感器阵列428、429被配置为以同气囊406圆周的大部分成径向发射高强度超声波能。该超声波能被图示为一系列曲线430。在一些代替实施例中,该超声波阵列可被排列为包含一相控阵,以聚焦该超声波能。前文还公开了一类似的相控阵,并图示在图2D中。该传感器阵列代表了一种用于向组织输送能量的方法,其目的在于烧蚀或破坏该组织,并减缓身体的自愈过程。
现在回到图4E,图示为另一扩张气囊406。气囊406被配置,以便被推到房间隔100中的一小穿孔,并如图示方式膨胀。气囊406进一步被配置,以便沿着一交叉导丝102被推动。气囊406一旦膨胀后即确定了一环形空间431,该空间被配置为可使流体围绕其圆周流动。在气囊406的近端,导管轴具有三腔截面432,如图4E的横截面细部图所示。图中以虚线434表示该横截面在该轴近端的位置。在该截面图中,中心管腔436被配置用于接收该交叉导丝。一叶状区域438代表膨胀流体的入口通道,另一叶状区域440代表该膨胀流体的出口通道。这两条通道分开连接到远端的一外部泵上。
图4E中的扩张气囊导管在两个阶段使用。首先,使气囊406膨胀,其方法为:关闭出口通道440并强制传热流体经过入口通道438,从而使气囊406膨胀。当该气囊在房间隔100内膨胀至满意程度时,穿孔被扩张,从而建立一房内压力释放孔。当气囊406完全膨胀后,传热流体被强制在气囊406内的环形空间431中循环。强制额外的传热流体经过入口管腔438,并使足够的流体流过出口管腔440,从而完成该过程。由外部泵控制出口管腔440的反向压力,例如使用带有摩擦离合器的齿轮泵。以这种方式,可提供足以保持气囊406膨胀的压力,并同时有大量流体流经气囊406。流经气囊406的传热流体可以是上述公开的任何一种相同流体。流经该气囊的传热流体可以使能量传入组织或从该组织传出,以烧蚀或破坏房内压力释放孔周围的组织。图4E所示扩张气囊导管以这种方式代表了一种方法,该方法建立了一房内压力释放孔并处理该孔周围的组织,以延长该孔的畅通时间。
图4A至4E描述的多种用于治疗房内压力释放孔周围组织的实施例,其目的并非为了列举可选用疗法的详细清单。例如,在一些附加实施例中,气囊可被配置为带有一微波发射器。在另一些实施例中,该气囊可纳入一电极网络,用于加热房内压力释放孔周围的组织。在另一些实施例中,气囊内径可包括一涂层,当其与膨胀流体混合,经受强烈的放热或吸热反应时,即可加热或冷却该组织。这些流体的例子包括水和生理盐水。在另一些实施例中,该气囊可涂有固定剂或生物相容性胶,可固定该组织并阻碍身体的普通愈伤反应。其例子包括嘧啶、氨甲喋呤、硫唑嘌呤、和放线菌素。还是在另一些实施例中,该气囊包括若干孔,用于使少量的乙醇渗出,以便烧蚀房内压力释放孔周围的组织。
现在回到图5,图示为额外的实施例。图中包括带有一圆锥形远尖端503的一扩张导管502。图示的导管502已扩张开房间隔100中的一穿孔,从而建立一房内压力释放孔。纳入扩张导管轴508的是一带有纹理或起棱纹的圆柱形部分504,可与导管轴508旋转耦合。导管轴508上的起棱纹部分被配置用于研磨或刮掉房内压力释放孔周围的组织,以促进疤痕组织增厚。在一些代替实施例中,导管轴508上的起棱纹部分可用该轴上固定的带有研磨材料的部分代替,如卷曲的不锈钢导丝或锋利的玻璃粉。
还是参考图5,导管轴508上的起棱纹部分耦合到扭矩传递元件506。扭矩传递元件506可为任何合适的灵活延长元件,能够沿导管轴508传递扭矩。在一些实施例中,扭矩传递元件506为三股驱动轴,每层丝朝相反方向转动。扭矩传递元件506可耦合到一外部驱动源,或被使用者人工转动,以研磨房内压力释放孔周围组织。在这种研磨以及导管502上起棱纹部分间的摩擦共同作用下,可促进形成增厚的疤痕组织,该疤痕组织转而减缓身体的愈合过程并有助于保持该压力释放孔的畅通。扩张导管502以这种方式代表了一种方法,用于建立一房内压力释放孔并延长其畅通时间。
在图5所示的一些代替实施例中,该轴上的纹理部分可相对于导管轴508的其余部分安装。在这种情况下,使用者只需接连不断地沿轴向推进或收回导管器械502,从而研磨房内压力释放孔附近的组织。可以这种方式使用一外部驱动源驱动导管502,或使用者只需手动驱动导管502。
还可使用其他技术在患者房间隔上建立开孔,以释放房内压力。图6A-6B描述了一项这种技术。在这项技术中,一穿线框被推进到房间隔开孔所需位置附近范围内。已被专业人士所熟知是,该穿线框可配备一不透射线的尖端或具有回波功能(未显示),以便医务人员在该过程中更好地监控设备。一些穿线框有一圆形的远端,以防对患者造成创伤,一些则具有一穿透端,如前面讨论的图1所述。如图1中进一步描述的该初始穿孔,可随后使用切割器扩大该开孔。
在图6A中,鞘104中的穿线框102已穿透房间隔100,建立了一初始开孔118。图6A中较小的平面图A描绘了初始开孔118与房间隔100的相对大小,所示观察点位于左心房。在图6B中,该开孔已被扩大到足以通过鞘104插入一固定和反应器械120,该器械带有引脚122。较小的平面图B再次从左心房内的观察点描绘了部署引脚122。固定和反应器械120可包括一系列支杆124和顶点,其方式非常类似美国专利8043360中所述引脚,该专利已分配给本申请的受让人,并全部纳入本文作为参考。该过程的目的是为了在直径标注为128的房间隔上准备一开孔。直径128的直径可以从约5毫米至约10毫米,这取决于患者的医生或其医保供应商提供的说明。引脚122应延伸至稍小于所需的最终直径或开孔128的尺寸。正如将被专业人士认识到的一样,这些引脚将用于固定从隔膜壁上摘除的组织。在一些技术中,穿线框102也将被留下以固定组织。既然穿线框102通常不足以摘除组织,该穿线框将被用于防止该组织在隔膜壁的一般区域上移动。
一旦这些引脚就位,将使用鞘104在该隔膜壁附近范围插入一射频探针,如图7A所示。射频探针130通过导丝132连接到一电源,以一种类似上述图2A所示方式。较小的视图C是该情况的平面图,其观察点还是从左心房内。带有支杆124的引脚和顶点126被部署在大致呈圆形的区域128内,组织将从该区域被摘除。如图所示,射频探针130可以是一圆形探针。该探针被充能以烧蚀组织并从房间隔上分开该组织。另一种选择是,该探针可包括一圆弧或一短长度。在这种情况下,以大致成圆形的方式顺序地移动或转动该探针,直到切除完成并且该组织被摘除。在一实施例中采用单极系统,旨在当切除术充分进行时,即当射频电流或电压到达引脚124时,关闭该系统。在另一些技术中,检测到电流或电压后可能存在一定延迟,以确保完成穿透组织。该技术的优点在于,在手术过程中的任何时候,该5-10毫米直径的组织所在位置一直处于医生和手术团队的掌握中。
如上所述,该射频探针可为单极的,并且患者受到一接地垫的保护。另一种选择是,采用双极技术,一个电极在患者左心房一侧或在患者外部。在另一技术中,该射频探针(第一电极)和接地探针(第二电极)可被置于房间隔相对的两侧。可在对探针充能并开始切除术前验证它们的位置。这种技术可用于圆形射频探针或较小的探针,其一般为圆弧形或长度很短。该过程将持续到切除术完成并且组织被摘除。
如图7B和侧视图D所示,切除术完成后,被分开或摘除的组织134可被器械120和引脚122固定,以便从患者身上移走或摘除。在一实施例中,使用器械120足以完成摘除工作,通过鞘104收回器械120即可从患者身上摘除初始开孔118内的组织134。在另一些实施例中,组织134可被穿线框102固定,并使用一抓手穿过鞘104抓住并摘除该组织,如美国专利Appl.12/954,468中所述,该专利被本申请的受让人共同拥有,并全部纳入本文作为参考。
带有固定尖头叉142的合适的抓手140的一个示例如图8所述。推动抓手140经过鞘102至隔膜壁附近范围。当足够接近组织134时即可部署该抓手,从抓手鞘142推动该抓手,使尖端144张开并抓住从患者房间隔上分开的组织。当尖端144与组织134足够近时,将这些尖端收回抓手鞘142中,这样尖端即可咬住该组织,尖端144咬住该组织并可以牢固地固定该组织。于是,被分开的组织通过鞘102从患者身上被摘除或移走。
除上述公开的实施例之外,可组合使用上述任何疗法治疗该组织。在这些实施例中,扩张房间隔上的穿孔以及治疗组织以减缓身体愈合过程这些步骤可使用一系列类似器械展开。
在另一实施例中,提供了一种治疗因心力衰竭导致肺静脉压力和左心房压力升高的方法。该方法包括使用任何本文公开的器械或方法建立一房内压力释放孔。该方法进一步包括采用手术治疗该房内压力释放孔附近组织的方法。该次级手术疗法包括任何上述疗法和器械,包括使用能量烧蚀组织或施药减缓身体的愈伤反应。
虽然已参考了各种附图和实施例,但应当理解,可由专业人士做出某些替代、增加和改变,并仍保持在本发明的范围内。为此,在附带的权利要求书中定义了本发明的范围:
术语“一”、“该”的使用和涉及描述本发明(特别是涉及到下面的权利主张时)的类似参照将解释为包括单数和复数,除非本文中另外指出或通过语境明确地否认。术语“包括”、“具有”、“含有”和“包含”将解释为开放性术语(即意味着“包括但不限于”),除非另作说明。本文中的数值范围列举仅作为对涉及在该范围内的每个单独数值的一种速记方式,除非本文中另外指出,并且每个单独数值均包含在规范之中,似乎其在本文中被分别地列举那样。本文所述所有方法均能以任何合适的次序执行,除非本文中另外指出或通过语境明确地否认。本文提供的任何或全部例子或示例性语言(例如“如”)仅是意图更好地说明本发明,不得对本发明的范围施加任何限制,除非另外声明。由于对本发明的实践相当重要,规范中的语言不应解释为表示任何非权利主张的成分。
本文公开的实施例,包括发明人已知的用于实施本发明的最佳模式。在阅读上述说明时,这些实施例中的变化可能对普通的专业人士变得显而易见。熟练的技术人员将在适当的情况下使用这些变化,发明人的本意是可以采用与本文的具体描述不同的方式实施本发明。因此,本发明包括所付权利要求书中被适用法律允许的各主题的所有修改和等价物。此外,上述元素在所有可能变化中的任意组合已包含在权利要求书中,除非在此处指明或其上下文明显存在矛盾。
Claims (9)
1.一种治疗心力衰竭的器械,该器械包括:
一具有外鞘套的导管和扩张导管轴;
该外鞘套内至少有一管腔;
一通过在患者心脏的第一高压心腔和第二低压心腔之间的房间隔中产生开孔而穿透该房间隔的穿孔器;
一用于将该开孔扩大为一第二明显扩大开孔的扩张器,从而在房间隔上建立一房内压力释放孔,其中所述扩张器包括带有纹理或起棱纹的圆柱形轴部分;和
至少一种机制,用于以干扰、减缓或降低人体的愈合能力的方式对该房内压力释放孔附近组织进行处理,以使房间隔上的该第二明显扩大开孔不需要使用内支架或阀门即保持畅通,
其中所述第二明显扩大开孔的大小足以使血液从第一高压心腔经过该房内压力释放孔流向第二低压心腔。
2.根据权利要求1中所述器械,其穿孔器是以下选择之一:一尖端、一导丝和一割具。
3.根据权利要求1或2中所述器械,其扩张器是以下选择之一:一圆锥形远尖端;一气囊导管,该气囊导管可操作性地包含承载该穿孔器的一中心通过管腔;和用于建立该第二明显扩大开孔的一组织烧蚀设备。
4.根据权利要求3中所述器械,其中所说的圆锥形远端包括用于增加该房间隔面积的一切割元件。
5.根据权利要求1或2中所述器械,其还包括用于从该房间隔上摘除组织的一抓手。
6.根据权利要求3中所述器械,其中所说的气囊导管进一步在其外表面或内表面包括一药用涂层,以在膨胀流体内产生放热或吸热反应。
7.根据权利要求3中所述器械,其中气囊导管包括若干孔,用于乙醇渗出以便对该房内压力释放孔周围的房间隔进行烧蚀。
8.根据权利要求1或2中所述器械,其中该第二明显扩大开孔的直径为5毫米至10毫米。
9.根据权利要求6中所述器械,其中该膨胀流体选自于以下组合:水和生理盐水。
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CN101426431A (zh) * | 2006-05-17 | 2009-05-06 | 赛恩泰克公司 | 用于治疗心律调节系统失常的可控设备、套件和方法 |
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CN107334512B (zh) | 2021-04-13 |
US11589854B2 (en) | 2023-02-28 |
AU2016269548A1 (en) | 2017-01-05 |
CN107334512A (zh) | 2017-11-10 |
IL227756A0 (en) | 2013-09-30 |
JP2014512869A (ja) | 2014-05-29 |
US8882697B2 (en) | 2014-11-11 |
JP2017060825A (ja) | 2017-03-30 |
US20190269392A1 (en) | 2019-09-05 |
EP2673038B1 (en) | 2017-07-19 |
EP3275390B1 (en) | 2019-06-19 |
EP2673038A2 (en) | 2013-12-18 |
EP3275390A1 (en) | 2018-01-31 |
IL252395A0 (en) | 2017-07-31 |
IL227756A (en) | 2017-06-29 |
AU2012214279A1 (en) | 2013-08-22 |
EP2673038A4 (en) | 2014-07-09 |
US20120259263A1 (en) | 2012-10-11 |
JP6358762B2 (ja) | 2018-07-18 |
WO2012109557A3 (en) | 2013-01-17 |
CA2827025C (en) | 2020-09-01 |
WO2012109557A2 (en) | 2012-08-16 |
AU2016269548B2 (en) | 2019-01-03 |
CA2827025A1 (en) | 2012-08-16 |
IL252395B (en) | 2020-04-30 |
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