CN102271750B - 在管腔中选择性地给药 - Google Patents

在管腔中选择性地给药 Download PDF

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CN102271750B
CN102271750B CN200980153036.0A CN200980153036A CN102271750B CN 102271750 B CN102271750 B CN 102271750B CN 200980153036 A CN200980153036 A CN 200980153036A CN 102271750 B CN102271750 B CN 102271750B
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energy
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medicine
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CN102271750A (zh
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M·皮瑞
C·W·斯通
R·T·古斯特斯
R·施莱伯
M·马泽尔
B·康恩
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Vessix Vascular Inc
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Minnow Medical Inc
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Abstract

公开用于通过涂层或者流体传输通道在管腔内选择性药物或者流体供给的方法和系统。一种系统包括长形的导管、热致变涂层和能量源，长形的导管具有近端和远端，近端与所述远端之间具有一条轴线，导管具有在远端附近的可径向张开球囊和接近球囊的能量传输部分，能量传输部分用于传输能量，热致变涂层具有与球囊连接的可释放药物，当可张开球囊张开时将热致变涂层定向成被压向身体组织，能量源与能量传输部分可操作地连接，将能量源构造成激励能量传输部分，以加热和液化热致变涂层从而将药物释放到身体组织。

Description

在管腔中选择性地给药
相关申请的相互引用
本申请在35USC 119(e)下要求2008年11月14日提交的美国临时申请No.61/114,958的优先权，该申请的全部公开内容通过引用并入本文。
关于本发明是在联邦政府资助的研究与开发下做出的权利的声明
不适用
技术领域
总体而言，本发明涉及医疗设备、系统和方法。具体地说，本发明提供使用基于导管的治疗系统用于选择性地给药至处于管腔周围的身体组织的方法和系统。
背景技术
医师使用导管以获得到身体的内部组织的通路并修复身体的内部组织，尤其在身体的管腔(例如血管)内。例如，经常使用球囊(balloon)血管成形术和其它导管来打开已经由于动脉粥样硬化疾病而变窄的动脉。球囊血管成形术在打开堵塞的血管方面经常是有效的，但是与球囊膨胀(dilation)相关的外伤会造成显著的伤害，使得球囊膨胀的益处在当今受到限制。
与球囊膨胀协同的支架术经常是用于的动脉硬化症的优选治疗措施。在支架术中，将折叠的金属构架安装在引入体内的球囊导管上。通过在下面的球囊的膨胀将支架置于堵塞部位内并张开到位。支架已经获得普遍的接受，并且在许多情况下产生总体上可接受的结果。支架还可以与血管(尤其是冠状动脉)的治疗措施一起用于治疗身体内的许多其它管腔阻塞(tubular obstruction)，例如用于治疗再生的、胃肠的和肺部的阻塞。支架术之后，身体管腔在相当多的情况下发生再狭窄或者后续变窄。
已经提出过多种改型的再狭窄治疗措施或者抑制再狭窄的治疗措施形式，包括血管内照射治疗，低温治疗，超声能量等，这些方法经常与球囊血管成形术和/或支架术相结合。虽然这些手段和其它各种手段在用于减少血管成形术和支架术之后血流中的后续恶化方面显示出不同程度的前景(promise)，但是由血管成形术最初强加于组织的损伤仍旧是个问题。
已经提出过对支架术和球囊血管成形术的许多替代方案用于打开狭窄的动脉。例如，已经公开和尝试过许多旋切术设备和技术。尽管血管成形术和支架术存在着缺点和限制，但是旋切术尚未获得广泛使用和基于膨胀手段的成功率。最近，膨胀的又一些缺点已经暴露。这些缺点包括存在易损斑块(vulnerable plaque)，易损斑块会破裂并释放可能引起心肌梗塞或者心脏病发作的物质。
最近，药物涂敷支架(例如Johnson and Johnsn的Cypher支架，相关的药物包含西罗莫司)已经证明了显著减少的再狭窄率，并且其它是正在开发和商品化的可选的药物洗脱(eluting)支架。虽然在许多患者中药物洗脱支架看起来可提供对动脉硬化症的治疗方案而言显著的前景，但是仍旧存在支架不能使用或者存在显著缺点的许多情况。一般而言，支架术将植入物留在体内。这种植入物可能存在危险，包括机械疲劳、腐蚀、血栓形成等，尤其当移除植入物较为困难并且涉及侵入式外科手术时更是如此。支架术对于以下治疗可能具有额外的缺点：用于治疗弥漫性动脉疾病，用于治疗分叉(bifurcation)，用于治疗怀疑压伤的身体区域，和用于治疗经受扭转、拉长和缩短的动脉。
鉴于以上所述，提供能够避免与药物洗脱支架和上述设备相关的缺点的、用于选择性地将流体供给至动脉组织的方法和系统将是有利的。
发明内容
总体而言，本发明提供用于选择性地将药物或流体供给至处于管腔周围的身体组织的设备、系统和方法。
在第一方面中，本发明包括用于选择性地给药至处于管腔周围的身体组织的系统。该系统包括具有近端和远端的长形的柔性导管体，在导管体的远端附近带有可径向张开的球囊。处于可张开球囊周围的能量供给表面和热致变药物涂层(thermally changeable drug coating)与球囊连接，当可张开球囊张开时，能量供给表面和热致变涂层定向成被压向(urge against)身体组织。能量源与能量供给表面可操作地连接，能量源构造用于激励能量供给表面，以加热和液化热致变涂层从而将药物释放到身体组织。
在另一方面中，本发明包括一种用于在导管中选择性地给药的方法。该方法包括当可张开球囊张开时使处于管腔周围的身体组织与能量供给表面和热致变涂层接合，热致变涂层具有处于导管的远端附近的可径向张开球囊上的可释放药物；选择性地激励能量供给表面以加热和液化热致变药物涂层的一些部分；和将药物从涂层释放到身体组织中。
在许多实施例中，能量供给表面包括多个电极，能量源选择性地连接至所述多个电极，从而选择性地激励电极对以加热和液化热致变涂层在电极对之间的部分从而将药物释放到身体组织。在许多实施例中，管腔的身体组织包括患病部分，并且挑选的电极对被激励以选择性地加热接近患病部分的热致变涂层。
在许多实施例中，能量供给表面包括处于可张开球囊附近的多个电极，从而当球囊在管腔内张开时，在组织中限定多个重塑(remodel)区域，电极与组织径向连接，并且在电极与组织之间传输能量。
在许多实施例中，进一步包括被构造用于辨别(characterize)身体组织的组织分析器。
在许多实施例中，能量供给表面响应于经辨别的身体组织而被激励，以加热热致变涂层从而释放药物。
在许多实施例中，管腔的身体组织包括患病部分，并且挑选的电极对被激励以选择性地加热接近患病部分的热致变涂层。
在许多实施例中，能量供给表面被激励以加热身体组织，与给药相结合。
在许多实施例中，热致变药物涂层包括多于一种的药物。
在许多实施例中，药物选自治疗流体、麻醉药物、治疗药物、小分子、基因治疗化合物(compound)、抗血栓形成剂、滑润剂(允许更高的温度而不会粘住)、用于降低电极处阻抗的导电化合物、用于防止治疗不需要治疗的组织的电绝缘化合物、趋于移动通过组织的内皮层以将能量传送给间质层的导电化合物中的至少一种，或上述选项的组合。
在另一方面中，本发明包括用于给药至处于管腔周围的身体组织的导管系统。该系统包括具有近端和远端的长形的柔性导管体，在导管体的远端附近的可径向张开球囊，和处于可张开球囊周围的能量供给表面。多个生物分子具有可经加热释放的药物部分和与球囊共价结合的惰性部分，并且能量源与能量供给表面可操作地(operatively)连接从而加热生物分子以将药物部分释放到身体组织。
在另一个方面中，本发明包括一种用于在管腔内流体供给的方法。该方法包括当可张开球囊张开时使处于管腔周围的身体组织与能量供给表面和多个生物分子相接合，生物分子具有可经加热释放的药物部分和与导管的远端附近的球囊共价结合的惰性部分；激励能量供给表面以加热生物分子；并且将药物部分从生物分子释放到身体组织中。
在许多实施例中，能量供给表面包括多个电极，能量源与多个电极可操作地连接从而选择性地激励电极对以加热电极对之间的生物分子以便将药物部分释放到身体组织。
在许多实施例中，管腔的身体组织包括患病部分，并且挑选的电极对被激励以选择性地加热接近患病部分的生物分子。
在许多实施例中，当可张开球囊张开时，能量供给表面和生物分子定向成被压向身体组织。
在许多实施例中，进一步包括被构造用于辨别身体组织的组织分析器，并且能量供给表面响应于经辨别的身体组织而被激励以加热生物分子从而释放药物部分。
在许多实施例中，与给药相结合，进一步激励能量供给表面以加热身体组织。
在许多实施例中，生物分子包括多于一种的可释放药物。
在许多实施例中，药物部分选自治疗流体、麻醉药物、治疗药物、小分子、基因治疗化合物、抗血栓形成剂、滑润剂(允许更高的温度而不会粘住)、用于降低电极处阻抗的导电化合物、用于防止治疗不需要治疗的组织的电绝缘化合物、趋于移动通过组织的内皮层以将能量传送给间质层的导电化合物中的至少一种，或上述物质的组合。
在另一方面中，本发明包括用于选择性地将流体供给至处于管腔周围的身体组织的导管系统。该系统包括具有近端和远端的长形的柔性导管体，在导管体的远端附近的可径向张开结构，当可张开结构张开时定向成被压向身体组织的多个流体传输通道，流体传输通道最初用热致变材料挡住，和能量源连接器，能量源连接器与流体传输通道可操作地连接从而加热和液化热致变材料以选择性地打开一个或多个流体传输通道便于流体释放。
在另一方面中，本发明包括用于选择性地将流体供给至处于管腔周围的身体组织的导管系统。该系统包括具有近端和远端的长形的柔性导管体，在导管体的远端附近的可径向张开结构，当可张开结构张开时定向成被压向管腔的身体组织的多个流体传输通道，流体传输通道最初是关闭的，和与流体传输通道连接以选择性地打开一个或多个流体传输通道并在管腔中释放流体的多个微电子机械系统(MEMS)。
在另一方面中，本发明包括一种用于在管腔中选择性地供给流体的方法。该方法包括当可张开结构张开时使处于管腔周围的身体组织与导管的远端附近的可径向张开结构上的多个流体传输通道相接合，选择性地打开一个或多个流体传输通道，并且将流体从挑选的流体传输通道释放到管腔中。
在许多实施例中，多个流体传输通道从可张开结构突出以刺入管腔的身体组织。
在许多实施例中，进一步包括被构造用于辨别身体组织的组织分析器以识别要治疗的身体组织，并且响应于经辨别的身体组织而选择性地打开或者关闭一个或者多个流体传输通道从而治疗被识别的身体组织。
在许多实施例中，流体传输通道可以响应于经辨别的身体组织而被选择性地激励，以选择性地打开或者关闭一个或多个流体传输通道。
在许多实施例中，可径向张开结构包括球囊，并且流体传输通道安装在球囊的周边上。
在许多实施例中，可径向张开结构包括可张开篮状物。并且流体传输通道安装在篮状物的周边上。
在许多实施例中，管腔的身体组织包括患病部分并且挑选的电极被激励以选择性地打开接近患病部分的一个或多个流体传输通道。
在许多实施例中，挑选的电极被激励以加热身体组织，与在管腔中释放流体协同。
在许多实施例中，选择性地打开一个或多个流体传输通道包括选择性地激励与挑选的流体传输通道连接的电极，以加热挑选的流体传输通道来液化最初关闭流体传输通道的热物质。
在许多实施例中，流体选自神经酰胺、苏拉明、雷帕霉素、紫杉醇、西罗莫司、佐他莫司、依维莫司、治疗流体、麻醉药物、治疗药物、小分子、基因治疗化合物、抗血栓形成剂、滑润剂(以允许更高的温度而不会粘住)、用于降低电极处阻抗的导电化合物、用于防止治疗不需要治疗的组织的电绝缘化合物、趋于移动通过组织的内皮层以将能量传送给间质层的导电化合物中的至少一种，或上述选项的组合。
在又一个方面中，本发明包括一种用于在管腔中选择性地供给流体的方法。该方法包括当可张开结构张开时使处于管腔周围的身体组织与导管的远端附近的可径向张开结构上的多个流体传输通道相接合，球囊材料是固定小孔尺寸的膜，并且向邻近于球囊表面的流体增加能量或者热，允许特定分子在特定时间(依靠接通或者切断能量源/热源)通过膜的特定区域。
附图说明
图1示意性示出具有涂层的导管系统的一个实施例，用于选择性地给药至处于管腔周围的身体组织。
图2示意性示出用于图1的导管系统的可充胀(inflatable)球囊的一个实施例。
图3A示意性示出图2的球囊的横截面视图，图3B是图2的球囊的放大视图。
图4A和4B示意性示出覆盖电极的涂层。
图5示意性示出在治疗组织中适体(aptamer)的使用。
图6示意性示出在给药之前、期间或之后在双极能量治疗(bipolarenergy treatment)中使用的电极对的放置。
图7示意性示出具有流体传输通道的导管系统的另一个实施例，用于选择性地将流体供给至处于管腔周围的身体组织。
图8A示意性示出图7中球囊的横截面，图8B是图7中球囊的放大的截面，该截面示出流体传输通道通过球囊连接至安装在球囊表面上的电极。
图9A和9B示意性示出显示使用生物分子进行组织治疗的横截面视图，生物分子具有可加热释放的活性部分和通过共价结合与球囊表面连接的惰性部分。
图10示意性示出具有膜的球囊的另一个实施例，用于选择性地给药至处于管腔周围的身体组织。
具体实施方式
已经开发出许多疗法来代替或者改进传统的球囊血管成形术和支架术。在本发明的背景技术部分中描述的可选设备切割、消融(ablate)或者汽化动脉中的患病组织。例如，激光设备使斑块(plaque)汽化并且将其冲刷到下游。旋切术设备切除斑块并将其吸出体外。切割型球囊切割动脉壁，损害组织。即使简单的血管成形术球囊也损伤组织。提供对身体组织不切割、消融或者汽化的治疗措施将是有利的。
本发明公开用于选择性地将流体供给至管腔中的身体组织，尤其是在管腔中选择性地给药的系统和方法。选择性供给还可以控制何时何处给药、和给药的量。
虽然本发明关注于给药，例如神经酰胺、苏拉明、雷帕霉素、紫杉醇、西罗莫司、佐他莫司、依维莫司、药物(麻醉的或者治疗的)，但是还可以将许多其它适当的流体供给至身体组织，例如，治疗流体、小分子、基因治疗化合物、抗血栓形成剂、滑润剂(允许更高的温度而不会粘住)、用于降低电极处阻抗的导电化合物、用于防止治疗不需要治疗的组织的电绝缘化合物、趋于移动通过组织的内皮层以将能量传送给间质层的导电化合物，或上述选项的组合。
在本发明的一些实施例中，将药物加入到球囊导管上的涂层中，该药物一次(once)经热释放(thermally released)到管腔内部以选择性地治疗组织。在其它实施例中，可以通过导管系统中的流体传输通道供给流体或者药物以选择性地治疗组织。在又一些实施例中，可以将多种流体或者药物作为涂层的一部分通过流体传输通道、通过穿膜的热渗透或者其任何组合进行供给。在一些实施例中，可以在一个组织部位供给药物，而在其它实施例中，可以将药物的多个部分供给至不同部位。
本发明的一些实施例使用加热来释放药物涂层。其它实施例在将流体或者药物供给至组织之前、期间或者之后，使流体或者药物供给与组织的加热相结合。使用射频(RF)、超声波、微波和激光能量来加热动脉组织的设备已经在共有待决美国专利申请No.11/975,474、No.11/975,383、No.11/122,263和美国临时申请No.61/099,155中公开，这些申请的全部公开内容通过引用并入本文。
血管成形术过程(angioplasty procedure)期间的给药
本发明的一些实施例提供用于在血管成形术过程期间与加热相结合的在管腔内给药的系统和方法。虽然公开了药物，但是也可以供给蛋白质、细胞和/或分子(在下面公开)。血管成形术过程自身是将打开管腔的过程。加热将造成病变(lesion)的变软和缩小，使斑块能够易于围绕球囊修整(reshape)，同时避免血管的拉伸(stretch)因此避免了对血管的伤害。在血管成形术过程和加热过程期间将释放药物。血管成形术过程期间的给药治疗将是下列的组合：
●压力-由球囊导致，为了打开管腔。压力可以是标准血管成形术膨胀的10-16个大气压或者可以是更柔和的6个膨胀大气压或更小，并且可能低如1至2个大气压。
●加热-由RF能量导致，为了使病变变软和缩小。加热还可以具有与药物或者给药相关的其它益处(下面讨论)。
●药物/蛋白质/细胞/分子-在过程中将被释放。
药物/分子/蛋白质/细胞元素可以由一种成分构成，或者与下列其它元素组合，例如：
1.药物：将能够防止或者减少平滑肌细胞(SMC)增殖和/或从中膜向内膜迁移(migration)的任何分子，例如：神经酰胺，苏拉明，雷帕霉素和紫杉醇。组织的加热在有助于给药至病变或者组织内、并且更加深入到中膜内的方面可以起到关键作用。
2.蛋白质：将能够减轻和治愈病变内部的炎症、或者能够防止或减轻SMC增殖和迁移的例如抗炎蛋白质(anti-inflammatory protein)、抗体和其它种类蛋白质的蛋白质。我们还可以使用将引发细胞凋亡或者细胞胀亡的蛋白质。加热在治疗期间激活这些蛋白质的方面可以起到关键作用，并且如果在过程期间快速加热，则能够使组织以最大时间暴露给蛋白质。为了确保在过程期间将蛋白质激活，人们应该考虑蛋白质的半衰期。蛋白质的半衰期是剩下对该特定蛋白质而言的蛋白库的任意一半之前所花费的时间，对于人类蛋白质，蛋白质的半衰期范围是从数分钟至80小时。为了使用蛋白质洗提球囊，需要将球囊保存在低温(＜0℃)中，从而使蛋白质不会被毁灭和消灭。可以与分子结合的几种蛋白质被命名为5′-三磷酸腺苷(ATP)。ATP是多功能核苷酸，作为细胞内能量转移的“分子流通物”它是重要的。在一个示例中，球囊覆盖有蛋白质而电极覆盖有ATP(或者反过来)并且将通过球囊充胀而释放蛋白质，并且在将从电极发射能量时释放ATP(或者反过来)。
3.细胞：用在过程期间能够迁移到病变的例如内皮、或者任何其它类型细胞的细胞涂敷球囊，这些细胞将释放蛋白质或者抗体以使炎症愈合或者防止SMC增殖和迁移。在这种情况下加热也用于在过程期间激活细胞。
4.分子或者蛋白质：当附连于热休克蛋白(HSP)时，该分子或者蛋白质能够附连或者变成激活的。HSP是当细胞暴露于升高的温度或者其它压力时其表达(expression)增大的一组蛋白质。例如，HSP27在平滑肌细胞(SMC)迁移中起作用。在这种情况下RF能量和加热将导致SMC内部HSP27的升高(elevation)，从而我们可以通过使用抗-HSP27抗体而对SMC直接使用任何药物/分子或者蛋白质。此概念是使用加热或者加热的结果，以便使用其它分子或者蛋白质来结合、降解(degrade)、抑制或者激活病变内和中膜内的其它蛋白质或者细胞，从而防止再狭窄。
给药涂层
图1示出导管系统10的一个实施例，导管系统10具有用于选择性地给药至处于管腔周围的身体组织的可释放涂层。导管系统10包括具有导管体14的球囊导管12，导管体14带有近端16和远端18。导管体14是柔性的并且限定导管轴线15，并且可以包括一个或多个管腔，例如导丝管腔22和充胀管腔24。导管12包括邻接远端18的可充胀球囊20和邻接近端16的外壳29。外壳29包括与导丝管腔22连通的第一连接器26和与充胀管腔24流体连通的第二连接器28。充胀管腔24在球囊20与第二连接器28之间延伸。第一连接器26和第二连接器28都可以可选地包括标准连接器，例如Luer-LocTM连接器。远端尖部可以包括一体化的尖部阀(tip valve)以允许导丝等通过。
外壳29还容纳电连接器38。连接器38包括多个电连接部，每个电连接部都经由导体36电连接至电极34。这使得电极34易于被激励，电极经常被控制器40和例如RF能量的电源42激励。在一个实施例中，电连接器38经由控制器40与RF产生器连接，控制器40能够将能量选择性地引导到电极34。虽然公开了RF能量，但是可以使用其它适当的能量源，例如微波能量、超声能量或者激光能量，每种能量都具有构造成供给所需能量的能量传输部分。参见共有待决美国临时申请No.61/099,155，其全部公开内容通过引用并入本文。
在一些实施例中，控制器40可以包括处理器或者与处理器连接以对治疗加以控制或者记录。处理器通常将包括计算机硬件和/或软件，经常包括运行机器可读程序指令或代码的一个或多个可编程处理器单元，用于实施本文描述的一种或多种方法的部分或全部。经常将代码嵌入到有形媒体中，例如存储器(可选地为只读存储器，随机存取存储器，非易失性存储器等)和/或记录媒体(例如软盘，硬盘驱动器，CD，DVD，非易失性固态存储器卡等)。还可以经由网络连接(例如无线网络，以太网，因特网，内联网等)将代码和/或相关的数据和信号传输给处理器或者从处理器传输代码和/或相关的数据和信号，并且部分或全部代码还可以经由一条或多条总线在导管系统10的各组件之间和在处理器内传输，并且在处理器内将经常包括适当的标准或者专有(proprietary)通信卡、连接器、电缆等。经常将处理器构造成执行本文描述的计算和信号传输步骤，至少部分通过用软件代码对处理器进行编程，可以将软件代码写成单个程序，一系列单独的子程序或者相关的程序等。处理器可以包括标准或专有数字和/或模拟信号处理硬件、软件和/或固件，并且通常将具有充分的处理能力以在患者治疗期间执行本文描述的计算，处理器可选地包括个人计算机、笔记本计算机、平板计算机、专有处理单元，或其组合。还可以包括与现代计算机系统相关的标准或专有输入设备(例如鼠标，键盘，触摸屏，操纵杆等)和输出设备(例如打印机，扬声器，显示器等)，并且可以在大范围的集中式或分布式数据处理结构中采用具有多个处理单元(或甚至是单独的计算机)的处理器。
在图2中更详细地示出球囊20。球囊20一般包括与充胀管腔24连接的近端部分30和与导丝管腔22连接的远端部分32。当用流体或者气体充胀时球囊20径向张开。在一些实施例中，流体或者气体可以是不导电的和/或被冷却的。在一些实施例中，球囊20可以是被加压以接触动脉组织的低压球囊。在其它实施例中，球囊20是允许更高压力从而既加热动脉组织又使动脉管腔张开的血管成形术球囊。球囊20可以包括柔顺的(compliant)球囊或者非柔顺的(non-compliant)球囊，非柔顺球囊具有螺旋状折叠(helical fold)以促进将球囊从径向张开的、充胀的构造重新构造成小截面的(low profile)构造，尤其用于使用后的去除。
将电极34安装在球囊20的表面上，相关的导体36从电极向近端延伸。可以在球囊20上将电极34布置成许多不同的图案或者阵列。该系统可以用于能量的单极或者双极施加。对于双极能量供给，相邻的电极沿轴向错开，以允许双极能量在相邻的圆周上的(沿轴向错开的)电极之间传导。在其它实施例中，可以将各电极布置成围绕球囊的带，以允许在相邻的远端电极和近端电极之间引导双极能量。
涂层35与球囊20连接并定位在各电极34之间，如图3A和3B所示。涂层35包括要供给至目标组织的流体或者药物。预想到：涂层将被热激活并构造成以高于体温(大于37℃)的温度从球囊表面释放。这个想法是具有能量供给或者加热，将涂层化合物的相从固态改变到液态，并释放药物。这个温度增大涉及使用RF能量激活电极34。随着能量增大，各电极34之间的涂层35被加热并且热释放到局部组织48。涂层35是坚牢的或者柔性的使得它能够与球囊20一起折叠而不分离或者分层。这个机制能够释放小分子药物或者大分子药物或者phrama产品。药物可以呈固体凝胶形式。
在一些实施例中，第二涂层35A可以用于覆盖电极34，如图4A所示。第二涂层35A可以是电极34上的绝缘涂层。当在管腔中的例如支架的金属物体内部治疗时，会使用第二涂层35A，因为如果电极34与金属相接触，则它们可能短路并且治疗将结束。如果电极34涂敷有带有电性质的物质，使得电极不会与金属物体短路，则甚至当与金属物体相接触时治疗也可以继续。这会使导管系统10能够在类似支架的物体内部治疗。第二涂层35A还可以用于使电极34与组织48绝缘，如图4B所示，这会停止/禁止能量流通过组织48和通过涂层35发送能量，仅仅加热各电极34之间的涂层35，将药物释放到组织48。第二涂层35A还可以包括不同于涂层35的药物。
在涂层中可以包括许多类型的药物。例如，涂层可以包括目前在药物洗脱支架中使用的药物，例如西罗莫司(在CypherTM支架中使用)，紫杉醇(在TaxusTM支架中使用)，佐他莫司(在EndeavourTM支架中使用)和依维莫司(在Xience VTM支架中使用)。
本发明的一些实施例可以包括使用基质(substrate)涂敷到球囊20上的适体52，在受到加热时，例如当激活RF能量源时，适体52容易破解(break down)。可以将适体制造成非常特定地结合于不同的分子目标，例如小分子，蛋白质，核酸，和甚至是细胞，组织和有机体。适体52可以被合成为带有期望的待治疗组织48(例如管腔或者动脉内的斑块)的带条(bind)54。
当导管系统10未加电并且球囊20被放缩(deflated)时，带有适体52的涂层35会保留在球囊20上。一旦球囊20被充胀并且接通能量单元，则涂层被释放并且适体52结合到期望的组织上，如图5所示。在一些实施例中，适体52会配合(conjugate)成微珠(microscopic bead)56，微珠56对例如由导管系统10发射的RF能量的能量58是高度接受的。珠56将RF能量直接转换成热能并且仅对于和适体52相接触的组织。
适体是以与抗体几乎相同的方式结合到分子表面的核酸。适体与抗体之间的一个重要差别在于，适体可由化学合成产生，而抗体是以生物方式产生的，首先是动物，然后是在养殖(culture)或者表达(expression)系统中产生。另一个重要差别在于，适体非常稳定并且对其周围环境(包括温度)不敏感。
在一些实施例中，涂层35可以包括具有能使斑块变软的特性的化学溶剂。醚、氯仿、苯和丙酮是已知的脂质溶剂。另外，氨基酸、蛋白质、碳水化合物和核酸在这些溶剂中很大程度上不能溶解。如果将溶剂与组织加热协同使用，则组织治疗可能在更短的时间段内进行，需要的能量更少，减小了对健康组织损害的机会。如果组织包括钙沉积，则用于将脂质溶剂供给至斑块的相同过程可以用于将钙溶剂供给至钙化部位。钙在多种有机溶剂中是高度可溶解的。在这两种情况下，溶剂都会与带有涂层的球囊表面结合，在施加热或RF能量、或者当球囊被充胀时，涂层会裂解。
在一些实施例中，涂层可以将本文列出的多于一种的药物、试剂或者流体加入到涂层中，每种都具有不同的相改变温度。例如，在可能存在神经的一般位置处，可以在更高温度的专门治疗之前以更低的融化温度给予(administer)麻醉剂。在一些实施例中，可以例如通过分层而使用不同物质的两个涂层。例如，第一层可以包括第一药物，第一药物附连于目标组织并用作对第二层中的第二药物的接受器。在一些实施例中，涂层是不导电的，以减少或者消除各电极之间的电短路。
在一些实施例中，组织签名(tissue signature)可以用于通过使用阻抗测量结果来识别治疗区域。利用管腔内沿径向相间隔的电极34的阻抗测量可以用于分析组织。当电流路径经过患病组织，和当电流路径经过管腔壁(luminal wall)的健康组织时，相邻电极对之间(和/或分开的电极对之间)的阻抗测量结果可能不同。因此，患病组织的任何一侧上的电极之间的阻抗测量结果可以指示病变，而其它的相邻电极对之间的测量结果指示健康组织。例如血管内超声、光学相干X线断层摄影术等的其它特性可以用于识别待治疗区域。
本文描述的一些实施例可以用于通过选择性地给药与“柔和加热”相组合来治疗动脉硬化疾病，“柔和加热”利用“Q10规则”以进一步增强流体或者药物治疗。在Q10规则下，当温度上升10℃时生物化学反应的速度通常翻倍是众所周知的。
如图6所示，电极34沿周向围绕球囊20定位。将RF能量43引向相邻的电极对34A和34C，或者34A和34D，或者34A-34D的任何组合，在管腔50内既治疗健康组织45又治疗动脉粥样硬化物质48。这种布置产生通过组织的能量路径43，该能量路径在特定治疗区域或者环节中将能量或热(“组织重塑能量”)供给至电极对之间的动脉组织(“重塑区域”)，该动脉组织具有在特定深度处电极对之间的某一容积。通过使用交迭的电极对，使用电极对的不同组合可以减少或者消除重塑区域之间的缝隙。使用具有双极能量的电极对可以避免单极手段的一些潜在的问题。患病的动脉组织48具有比健康的动脉组织更高的电阻。通过在双极系统中使用电极对34A、34B，组织重塑能量将通过在重塑区域中的电极对之间的健康组织、患病组织、或者健康和患病组织两者的结合。可以按不同的图案或者阵列使用任何数量的电极对以产生许多重塑区域。控制器可以施加恒定功率、恒定电流或者恒定电压，哪一个具有最大的优势就采用哪一个。
控制器40可以用大约0.25至5瓦特平均功率激励电极1至180秒，或者用大约4至45焦耳。更高能量的治疗在更低功率和更长持续时间下进行，例如0.5瓦特用于90秒或者0.25瓦特用于180秒。大多数在2至4瓦特范围内的治疗都在1至4秒内执行。使用更宽的电极间隔，按比例增大治疗的功率和持续时间将会是适当的，在这种情况下平均功率可以高于5瓦特，并且总能量可以超过45焦耳。同样，使用更短或者更小的电极对会需要按比例调整平均功率，并且总能量可以小于4焦耳。功率和持续时间被校准到小于足以造成严重损害的值，并且尤其要小于足以消融血管内的患病组织48的值。
在一些实施例中，供给药物和柔和加热可以伴随使用柔和膨胀的球囊血管成形术，以利用膨胀压力重塑动脉，膨胀压力是正处于或者显著低于标准的、未加热的血管成形术膨胀压力。球囊充胀为10-16个大气压例如对于特定病变的标准血管成形术膨胀可能是适当的，本文描述的与适当的电势(通过球囊上的柔性电路电极，直接沉积在球囊结构上的电极等)相结合的经修改的膨胀治疗可以采用从10至16个大气压或者可以通过6个或者更小的大气压、和有可能低到例如1至2个大气压来实现。这种中等膨胀压力可以(或者可以不)与本文描述的组织特征、调整的能量、偏心治疗(eccentric treatment)和其它治疗方面的一个或多个方面相结合，用于治疗外周血管(peripheral vasculature)的疾病。
共价结合的生物分子
目前用于防止或者永久去除增生内膜的血管内疗法并不是完全有效的。虽然通过多次这种疗法来获得对这种组织的去除，但是组织的再生长频繁地发生，导致再狭窄和机能不良的血流。药物洗脱支架能够抑制再狭窄的频率，但是达不到完全恢复血管功能，这是由于存在持久的植入物：支架。
最近，药物凝固球囊(drug clotting balloon)在再狭窄的频率方面已经比药物洗脱支架显示出甚至更大的减小，并且在治疗之后被去除，然而，需要高压充胀来最佳地供给抗细胞增殖/抗炎生物分子。这些分子可以通过防止炎性细胞涌入(趋化现象(chemo taxis))、细胞增殖而起到防止再狭窄的作用。这些分子还可以通过提供结构性支持，因此“设定”管腔直径而起到稳定IEL矩阵(IEL matrix)的作用。
图9A和9B示出用于给药至身体组织248的导管系统200的另一个实施例。系统200类似于上面的系统10，不同之处在于使用与球囊20连接的生物分子235而不是涂层。生物分子235包括热释放活性部分235a和通过共价结合与球囊20表面连接的惰性部分235b。活性部分或分子235b能够治疗期望的组织248，这可以通过温度或者压力来增强。生物分子的惰性部分235a继续停留在球囊上。本文描述的实施例利用射频血管内球囊导管，在低压充胀和从球囊供给能量至动脉硬化病变的基础上，射频血管内球囊导管超热(hyper-thermally)释放生物分子的与球囊共价结合的活性部分，因此，将分子的活性部分供给至目标组织。能量还可以包括超声发射的能量。活性分子235b通过任何手段起到防止产生增生的组织的作用，这些手段包括但不限于白细胞郁滞(防止有丝分裂)，受体化脓(maturation)(即，在目标组织上的细胞处/上的这些受体，这些受体由于趋药性(chemotactic))而粘合于促进增生组织形成的浸润细胞)。
通过引起局部过热环境的能量供给(例如从电极34)从完整的生物分子235释放分子的生物活性部分235b。分子在过热条件下是稳定的。分子可以防止一个或所有的下列功能：
●细胞增殖；
●细胞功能；
●受体配位体结合；
●炎症细胞对目标组织的趋化现象和
●原有动脉层中的细胞迁移到患病组织。
通过能量促成的降低体温分子来促进和/或加快分子235b流入患病组织48，即，由完整的生物分子细胞分裂，迁移到患病组织中，并且依靠增加的孔隙驻留在患病组织内也都通过降低体温来加速。
本发明独特地利用以下方法将生物活性分子供给至患病组织中：
●更大速度，通过降低体温加速；
●更加完全，通过使患病组织对于分子更能接受/更加多孔；和/或
●利用生物分子的非活性环节，即，非聚合物，非活性蛋白质序列/环节，或者对于在治疗部位剩余的活化所需的辅助因子(co-factor)(继续停留在球囊上的非活性环节)。
设计临床应用和使用以减少斑块，抑制在支架部位或者非支架部位中的再狭窄，并可以用做对侵入型不可植入的(aggressivenon-implantable)血管内过程和支架植入的附加治疗。
流体传输通道
图7示出具有流体传输通道的导管系统100的另一个实施例，用于选择性地将流体供给至处于管腔周围的身体组织。导管系统100包括具有导管体114的球囊导管112，导管体114带有近端116和远端118。导管体114是柔性的并且限定导管轴线115，还可以包括一个或多个管腔，例如导丝管腔122和充胀管腔124。导管112包括邻接远端118的可充胀球囊120和邻接近端116的外壳129。外壳129包括与导丝管腔122连通的第一连接器126和与充胀管腔124流体连通的第二连接器128。充胀管腔124在球囊120与第二连接器128之间延伸。第一连接器126和第二连接器128都可以可选地包括例如Luer-LocTM连接器的标准连接器。远端尖部可以包括一体化的尖部阀以允许导丝等通过。
外壳129还容纳电连接器138。连接器138包括多个电连接部，每个电连接部都经由导体136与电极134连接。这使得电极134易于被激励，电极经常被控制器140和例如RF能量、微波能量、超声能量或者其它适当的能量源的电源142激励。在一个实施例中，电连接器138经由控制器140与RF产生器连接，控制器140允许将能量选择性地引导至各电极134或者电极对。控制器140可以包括处理器或者与处理器连接以对治疗加以控制或记录。
图8A示出球囊120的横截面，图8B是示出流体传输通道160通过球囊120与安装在球囊120表面上的电极134连接的放大的截面。电极134包括从电极向近端延伸的相关导体。可以在球囊120上将电极134和流体传输通道160布置成许多不同的图案或者阵列。流体传输通道160可以与保存流体152的流体贮存器或者管腔162连接。在一些实施例中，充胀介质可以含有待供给的流体。在一些实施例中，穿过球囊120的通道160可以用可被加热排出以便打开通道的蜡状物质164(或者可以被排出的任何其它物质)填充。在其它实施例中，电极134可以打开和关闭口盖(flap)以释放流体。
流体通道160可以从球囊表面突出以使它们能够刺入管腔的身体组织。在一些实施例中，电极可以刺入身体组织。
导管系统100还可以包括被构造用于辨别身体组织的组织分析器。在一些实施例中，电极134可以是如上所述的感测电极，感测电极可以使用电阻X线断层摄影术来帮助辨别组织以识别待治疗的区域或者不需治疗的区域。例如血管内超声、光学相干X线断层摄影术等的其它特性可以用于识别待治疗的区域。电极134可以被激励以响应于经辨别的身体组织。
本文描述的一些实施例可以用于通过选择性流体供给与“柔和加热”相结合来治疗动脉硬化疾病，以进一步增强流体供给或者治疗，如上所述。
可以选择性地激励电极134以打开或者关闭流体传输通道160从而治疗组织。一种方法包括通过选择性地加热电极(通过焦耳加热或者其它手段，包括引起相邻区域内的温度升高，由此热传递可以加热一个或多个电极)来打开流体传输通道160，使得否则会挡住通道的物质164的相从固态改变到液态。另一种可行的方法可以包括使用MEMS(微电子机械系统)以选择性地打开和/或关闭通道160。
在一些实施例中，流体传输通道可以是通过电极(被灌注的电极(perfused electrode))的孔。孔或者小洞可以用于将流体供给至最接近电极的动脉组织。洞的直径可以小于1μm并且可以用激光或者离子束制得。可以在电极和球囊中制成洞。在一个实施例中，柔性电路上的电极极板设计有被电镀的孔。将柔性电路安装在球囊上并且使用激光或者离子束在柔性基质和球囊中产生洞。对于每一个电极极板可以在柔性/球囊中存在几个洞。于是可以用标准灌注球囊设备或者专用设备来灌注球囊。这种灌注方法除了流体供给之外还可以提供额外的优点，例如消除了刺入(sticking)，带走热或者调节负载的阻抗。
在一些实施例中，可以使用具有微观级别的流体传输通道的多孔球囊，用增加的热来允许挑选的分子通过。多孔球囊可以具有内层、多孔的外层或者膜，药物或者流体分子位于层(即贮存器)与连接至外层的电极之间。低压时，分子停留在贮存器内。当施加热时，分子可以通过多孔层，这可以用不同方式做到。例如，当施加热时，药物分子可以被激励，提供足够的力来通过多孔的外层。在另一个示例中，当给球囊施加热时，小孔张开，允许药物分子通过多孔的外层。分子还可以借助于渗透压力以及加热而通过多孔的外层或者膜。
在一些实施例中，治疗可以包括药物，和/或热的，和/或小分子或大分子注射，和/或RF，和/或球囊膨胀，和/或过热。
虽然本文公开的设备、系统和方法将球囊讨论为可径向张开结构，但是还可以使用其它可张开结构，例如在美国专利申请No.11/975,651中描述的那样，该申请的全部公开内容通过引用并入本文。
热激发的ozmolarity
在一些实施例中，可以使用在膜内具有微观级别的流体传输通道的多孔球囊，用增加的压力和热来允许分子通过。这个概念通过使流体或者药物通过膜而将其供给至特定部位，与反渗透非常相象。在反渗透中，使用压力来推动例如水的液体通过膜，通路是如此之小以至于只有适当的分子可以通过。在这个实施例中，膜屏障保留药物，象紫杉醇。低压时药物分子不能通过膜。为了通过膜释放药物，使用球囊给药物分子施加压力，通过由电极对或者单极电极局部施加能量使药物的释放加速。
图10示出类似于导管系统10的一种导管系统的一个实施例，该导管系统具有带非多孔内部球囊305(用于提供压力)的球囊300，多孔的外层，膜或者套310，位于内部球囊305与膜310(即贮存器)之间的药物或者流体315，和与膜310连接的电极320。电极320可以类似于上述电极。
在使用中，将球囊放在期望的组织部位并且使球囊充胀到适当的压力，例如4-6ATM。当激励电极时，热能造成膜小孔打开并且造成药物分子激发且使它们通过小孔前进到组织。
本文公开的设备、系统和方法可以用于在任何动脉中选择性地供给流体，例如，股动脉，腿弯部动脉，冠状动脉和/或颈动脉。虽然本发明关注于在脉管系统中使用该技术，但是该技术对于任何管腔阻塞(luminal obstruction)同样会有用。可以使用本发明的其它解剖学结构是食道，口腔，鼻咽腔，咽鼓管和鼓膜腔，脑静脉窦(sinus of brain)，动脉系统，静脉系统，心脏，喉，气管，支气管，胃，十二指肠，回肠，结肠，直肠，膀胱，输尿管，射精管，输精管，尿道，子宫腔，阴道和子宫颈。
本文公开的设备、系统和方法可以采用多种多样的机制中的一种或多种来促进、推进和/或增强从导管(或者其它供给结构)的流体、凝胶或者固体的至少一种药物向期望的治疗部位或组织的传输，和/或将其传输到期望的治疗部位或组织中。上面描述了可以采用的示例性加热促发的药物传送机制。还可以使用其它机制，包括电促发的药物传送机制，可选地包括例如电穿孔(electroporation)、离子电渗疗法等的机制。电穿孔可以在细胞内允许目标药物分子经由在细胞膜内产生的通路。电穿孔可以通过施加外部电场、可选地通过使用本文描述的球囊导管的一个或多个电极施加电穿孔电压(电穿孔电压可以涉及一系列的电穿孔电势)而显著增加细胞质膜的导电性和渗透性。可以通过施加相对小的电势而采用离子电渗疗法，从而通过管腔的表面供给药或者其它化学药品，仍然可选地使用本文上述的球囊导管的一个或多个电极施加电势。作为另一个示例，可以经由电离子透入疗法的膜将抗炎分子供给至动脉硬化病变处。可以经由使用本文描述的设备和系统以离子电渗疗法的方法将抑制炎症、血栓形成和血栓症的小分子抑制剂供给至动脉硬化病变处，以使动脉硬化和血栓形成的进程变慢、或者防止动脉硬化和血栓形成的进程。动脉中适当的炎症和/或形成血栓的组织目标的示例可以包括血小板内皮细胞粘附分子(PECAM)，组织因子(TF)，子宫金属蛋白酶(matrixmetalloproteinases)(MMP)和/或类似物。会经得起经由离子电渗疗法供给的小分子抗炎症/抗血栓症疗法的示例可以包括肝磷脂、肝磷脂硫酸盐和/或类似物。有利地，可以在双极布置(在球囊导管的电极之间)或者在单极模式中施加适当的电势。可以通过市售的离子电渗疗法或者电穿孔系统施加适当的电势，或者可以采用专用的电势产生器。可以例如通过所使用的热机制(例如，通过激励电极从而加热涂层，和可选地促进药物的释放和加热增强药物进入目标组织的运动)可选地结合这些药物传送机制，随后电促成药物传送机制(可选地通过用适当的电势激励球囊的相同电极或者不同电极)。
虽然通过示例和为了清楚的理解已经在某种程度上详细地描述了示例性实施例，但是本领域技术人员将意识到可以采用多种更改、适应和改变。因此，本发明的范围应完全由所附权利要求限定。

Claims (14)

1.一种与能量源一起使用的、用于给药至处于管腔周围的身体组织的导管组件，所述导管组件包括：
长形的导管，其具有近端和远端，所述近端与所述远端之间具有一条轴线，所述导管的所述近端能够与所述能量源连接，并且所述导管具有在所述远端附近的可径向张开的球囊和接近所述球囊的能量传输部分，所述能量传输部分用于从所述能量源传输能量，其中，所述能量传输部分包括安装在可径向张开的所述球囊的表面上的多个电极；
药物；和
热激活物质，其在插入构造中沿着所述球囊可释放地约束所述药物，当所述球囊在所述管腔内张开时，所述热激活物质能够响应于能量而被加热以重新构造，从而将所述药物从所述球囊供给至所述身体组织；
其中，所述能量源通过控制器可操作地连接到所述多个电极，所述控制器被构造用于选择性地激励所述多个电极中的一个或多个电极，以便选择性地加热和液化所述热激活物质的一部分，从而将所述药物释放到所述身体组织，其中所述热激活物质的一部分小于整个所述热激活物质。
2.如权利要求1所述的导管组件，其中所述热激活物质包括选自由以下选项构成的组中的至少一项：
热致变涂层物质，在所述插入构造中，所述热致变涂层物质和所述药物形成处于所述球囊上的涂层；
至少一种惰性生物分子，其在所述插入构造中将所述药物连结至所述球囊；和
至少一个微电子机械系统，其与内置有所述药物的至少一个相关的流体传输通道可操作地连接，从而在所述插入构造中约束所述药物。
3.如权利要求1所述的导管组件，其中所述热激活物质包括热致变涂层，该热致变涂层具有连接到所述球囊上的可释放药物，当可张开的所述球囊张开时，所述热致变涂层定向成被压向所述身体组织。
4.如权利要求1所述的导管组件，其中所述多个电极布置在可径向张开的所述球囊周围，从而当所述球囊在所述管腔内张开时在所述身体组织内限定多个重塑区域，所述多个电极与所述身体组织径向连接，并且在所述电极与所述身体组织之间传输能量。
5.如权利要求3所述的导管组件，进一步包括被构造用于辨别所述身体组织的组织分析器。
6.如权利要求5所述的导管组件，其中所述能量源构造用于响应于经辨别的所述身体组织而激励所述能量传输部分以加热所述热致变涂层，从而释放所述药物。
7.如权利要求3所述的导管组件，其中所述能量源构造用于激励所述能量传输部分以在给药之前、期间和/或之后加热所述身体组织。
8.如权利要求3所述的导管组件，其中所述热致变涂层包括多于一种的可释放药物。
9.如权利要求3所述的导管组件，其中所述药物选自神经酰胺、苏拉明、雷帕霉素、紫杉醇、西罗莫司、佐他莫司、依维莫司、治疗流体、麻醉药物、基因治疗化合物、抗血栓形成剂、用于允许更高的温度而不会粘住的滑润剂、用于降低电极处阻抗的导电化合物、用于防止治疗不需要治疗的组织的电绝缘化合物、趋于移动通过组织的内皮层以将能量传送给间质层的导电化合物中的至少一种，或上述选项的组合。
10.如权利要求3所述的导管组件，其中所述能量源是RF能量源，并且所述能量传输部分被构造用于传输RF能量。
11.如权利要求3所述的导管组件，其中所述能量源是激光能量源，并且所述能量传输部分被构造用于传输激光能量。
12.如权利要求1所述的导管组件，其中所述能量源是超声能量源，并且所述能量传输部分被构造用于传输超声能量。
13.如权利要求1所述的导管组件，其中所述能量源是微波能量源，并且所述能量传输部分被构造用于传输微波能量。
14.如权利要求1所述的导管组件，其中所述热激活物质包括多个生物分子，所述多个生物分子具有可经加热释放的药物部分和与所述球囊共价结合的惰性部分；并且所述导管组件进一步包括
所述能量源，其中所述能量源与所述能量传输部分可操作地连接，从而加热所述生物分子以将所述药物部分地释放到所述身体组织；其中，所述能量源构造成选择性地激励电极对，以便加热所述电极对之间的所述生物分子，从而将所述药物部分释放到所述身体组织；其中所述管腔的所述身体组织包括患病部分，并且挑选的电极对被激励以选择性地加热接近所述患病部分的所述生物分子；并且其中，当可径向张开的所述球囊张开时，所述生物分子定向成被压向所述身体组织。
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