CN1239127C - 带有可膨胀的环形透镜的能量施加装置 - Google Patents

带有可膨胀的环形透镜的能量施加装置 Download PDF

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CN1239127C
CN1239127C CN01812752.5A CN01812752A CN1239127C CN 1239127 C CN1239127 C CN 1239127C CN 01812752 A CN01812752 A CN 01812752A CN 1239127 C CN1239127 C CN 1239127C
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balloon
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ultrasonic
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E·P·哈亨
T·菲耶尔德
P·D·洛帕斯
D·E·阿克
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Recor Medical Inc
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Abstract

用来摘除包围管状解剖学结构的组织的装置和方法，摘除的组织例如有血管壁或包围尿道的前列腺组织。该装置包括一诸如圆柱形发射器的超声波发射器(720)以及一包围超声波发射器的、可膨胀的环形透镜气球(717)。该透镜气球用一具有不同于包围介质声速的声速的液体来膨胀，从而形成一环形的折射表面。来自发射器的声能聚焦到一环形集中区域(737)。

Description

带有可膨胀的环形透镜的能量施加装置
技术领域
本发明涉及诸如高热的医疗过程，以及涉及适合用于这些过程和其它过程的装置。
背景技术
在某些医学过程中，要求加热包围管状解剖学结构的组织，例如，血管或胃肠的，泌尿的，生殖的，或呼吸的结构。根据处理的情况，对构成结构壁的组织，或包围壁的组织施加能量。施加能量所形成的热度应足以造成组织的死亡。这种程度的加热本文中称为“摘除”。通常加热到约60-80°就足够了。
例如，包围男性尿道的前列腺可以变得肥大而使尿道狭窄。为了缓解这种情况，可以摘除前列腺组织。
此外，心脏的收缩或“搏动”由在心脏内的结所产生的电搏动控制，并沿着心脏壁内的传导通道传输。某些被称之为心律失常的心脏疾病包括产生异常的电搏动或异常的传导。这样一种心律失常是心房纤维性颤动或“AF”。某些心律失常可以通过沿一跨越一异常传导路线的路径故意破坏心脏壁的组织而得到治疗。这沿着发生破坏的路径形成一疤痕。疤痕阻滞电搏动的传导。通过在一肺静脉壁内延伸的异常结构可传播异常电搏动。这些异常的电搏动可通过在肺静壁上或在肺静脉的开口或口上形成一疤痕而得到阻滞。
例如，如Lesh(国际专利公开WO99/02096)中所述，这种摘除的实施可通过将一在其末端具有一热摘除元件的导管穿入心脏，这样，末端就容纳在合适的肺静脉内。该导管带有一气球，它在静脉内膨胀并保持导管就位。然后，启动摘除元件，于是将热量施加到包围摘除元件的区域。在’096专利公开中所传授的某些实施例中，摘除元件包括一无线电频率(“RF”)发射元件，它装载在气球的表面上。利用RF能量的肺静脉摘除可在静脉的内部形成一粗糙的破坏表面。这种因素和其它因素可导致肺静脉的狭窄或血栓形成，即，血块的形成。
在’096的专利公开中所述的其它实施例公开了超声波转换器的使用。’096专利公开中所示的优选的超声波转换器是一种设置在被气球包围的导管上的刚性陶瓷压电元件。当气球膨胀时，压电元件仍保持远离肺静脉壁。压电元件可被启动而通过包含在气球内的流体施加声能，由此，加热包围气球的静脉壁组织的环。作为另一个可供选择的实例，’096专利公开示出一种呈中空凹盘形式的超声波发射器。’096专利公开建议，这样一种发射器可以绕导管的轴线转动，从而摘除一环形的区域。这些转换器具有许多缺点。
诸如高强度焦点超声(HIFU)的超声加热用于许多治疗的应用中。如国际专利公开号为WO/98/52465的共同转让的国际专利申请PCT/US98/1062所公开的，本文已援引该公开以作参考，进行HIFU加热通常使用一具有一阵列转换器的超声波发射器。用一驱动信号来启动诸转换器，以发射超声波。波的相对相位由阵列的编排结构和驱动信号的相位控制。对这些因素进行选择，使超声波在一焦点位置趋于相长地相互加强。处于焦点位置处的组织比其它位置处的组织更大程度上加热。例如，如在2000年2月2日申请的悬而未决的、共同转让的美国专利申请09/496,988和悬而未决的、共同转让的美国专利申请09/532,614中所述，本文也援引这些公开内容以作参考，可通过诸如聚合物压电转换器的阵列的转换器阵列来施加HIFU。这些阵列可安装在一探头上，例如，一导管上，导管可以引入到体内，例如，血、脉管系统内或器官内的空洞。’988专利申请公开了某些转换器阵列，它们可以变形，从而改变焦点位置的设置。
Crowley的美国专利5,630,837公开了一种携带超声波转换器阵列的探头，转换器阵列包括沿一共同轴线互相隔开的多个圆柱形元件。该探头可插入解剖学结构中，并被启动而形成包围转换器阵列的一环形伤口。通过调整从各圆柱形元件发射的超声波的相位，使超声波能量集中到一环形的集中区域。
尽管在该技术领域内作了上述各种努力，但用来对包围管状解剖学结构的组织施加热能的装置和方法还需进一步改进。特别是，要求提供能将强度大的能量施加到环绕管状结构的圈或环上的简单装置，且该装置能紧紧控制能量施加区域。相应地还有要求进一步改进用于对人体其它器官进行热治疗而施加能量的装置和方法。
发明内容
本发明的一个方面是提供对身体内的活体组织施加能量的装置，例如，对包围管状解剖学结构的壁的组织施加能量。根据本发明这一方面的装置包括：具有一发射表面的超声波发射器，发射表面一般呈现为绕一中心轴线的回转表面的形式；一可膨胀的透镜，所述透镜具有一折射表面，折射表面呈现为当所述透镜处于膨胀状态时，绕与所述发射表面同轴的所述中心轴线并包围所述发射表面的回转表面的形式，所述透镜包围所述发射器，这样，在所述发射表面上发射的至少一些超声波能量将被导向通过所述透镜的所述折射表面进入身体的组织内；还包括一细长的探头，所述探头具有一近端和一适于插入活体的身体内的远端，所述发射器和所述可膨胀透镜安装在靠近远端的所述探头上。
在操作中，至少超声波的有些能量，且最好在发射表面上发射的大部分或全部超声波能量，通过透镜的折射面而导向，且导向到包围中心轴线的一环形区域。该环形区域最好具有比发射表面的轴向范围小的轴向范围。基本上覆盖发射表面的全部轴向范围发射的功率将导向该环形区域，并因此集中在该环形区域，以提供有效的热治疗。能量集中促进快速加热，并最大程度减小对临近组织的附带的损害。
该装置可包括一适于与管状解剖学结构的壁接合的结构，且将发射器相对于解剖学结构保持在一预定的位置，较佳地保持在解剖学结构的中心处，这样，集中区域相对于解剖学结构的壁精确地定位。保持发射器的结构可包括一包围透镜和发射器的承载气球。理想的是，当承载气球膨胀时，它具有一预定的形状。可膨胀的透镜和承载气球设置有分离的孔道，这样，具有大致相同声阻抗但不同声速的不同流体可被引入到透镜和承载气球使它们膨胀。通常，处于膨胀状态的承载气球也呈现诸如圆柱形的回转表面的形式，发射器和透镜与承载气球同轴。放置承载气球以轻微伸展解剖学结构，这样，使解剖学结构的壁形成与透镜和发射器同轴的精确圆形，由此，相对于壁精确定位透镜和发射器。在另一些实施例中，透镜本身接合和扩张解剖学结构壁，且因此起保持发射器与解剖学结构壁精确关系的作用。
透镜和发射器可布置成将集中区域放置在包围管状结构的壁或其它组织内，这样，超声波能量汇集到组织内的一焦点上，而不是在壁的表面上。在焦点放置在组织内而不是在组织的表面上的做法，最大程度上减小表面上的结疤，且促进快速加热。
或者，装置可布置成以平行的大致盘形的图形从集中区域向外引导声能。如下文将详细所述的，这至少要求两个界面。在透镜的表面的第一界面，朝向一环形集中区域的平面轴向向内折射超声波，而第二界面折射向内导向一基本径向方向。这样一个径向的、平行的图形在进入周围组织的相当深度提供相当高的声强度。这便于具有足够深度的热处理区域的形成，例如，完全穿过肺静脉或肺静脉口的壁的一摘除区域，从而确保可靠地中断存在于心房纤颤中的异常传导路径。一径向扩展的图形还便于如下的摘除或其它的热处理，解剖学结构不是精确圆形，或透镜和发射器不能与解剖学结构精确同心地定位。
本发明涉及的一方面是提供处理包围管状解剖学结构的组织的方法。根据本发明的这方面的方法，包括下列诸步骤：定位一具有一发射表面的细长发射器和一具有一折射表面的透镜，发射表面呈现为绕一中心轴的回转表面的形式，折射表面呈现为与发射器表面同轴的回转表面的形式，这样，发射器和透镜基本上与管状解剖学结构同轴；启动发射器以发射声能，这样，声能导入一基本环形的区域，它与透镜和发射器同轴，因此，基本上与解剖学结构同轴。环形区域最好具有基本上小于发射器的轴向范围的轴向范围。
如结合装置的上面所述，将声聚焦到一相当小轴向范围的环形区域内，可集中声能并允许有效的和精确的热处理。特别是，将声能集中到一相当小的轴向区域有利于包围解剖学结构的组织的环形部分的迅速加热。这便于在这样的环形区域的摘除或其它热处理，并有助于限制邻近组织的不希望的加热。根据本发明的这方面的方法可用来摘除肺静脉或肺静脉口，以治疗心房纤颤，用来治疗前列腺以及其它的病例。
本发明的其它目的，特征和优点，从结合附图对下面例举的优选实施例的详细描述中，将变得更为清晰明了。
附图简要说明
图1是示出按照本发明的另一实施例的装置的局部示意图，该实施例与一血管相联系。
图2是沿图1的线2-2截取的示意性截面图。
图3，4，5和6是类似于图1的视图，但示出根据本发明的另一些实施例的装置。
图7是用于本发明的一实施例的转换器的端视图。
图8是图7的转换器的截面图。
图9是图7和8中的转换器的一部分的立体图。
图10是图8所示区域的放大的局部图。
具体实施方式
根据本发明的一实施例的装置(图1和2)包括一含有单个多腔导管716的探头结构710。在导管近端的一第一接头705与腔室701连通，而在导管近端的另一接头707与腔室703连通。具有一通常呈现回转表面形式的发射表面的发射元件720安装在导管716的靠近导管远端709处。发射元件形成垂直于中心轴线724的、在发射元件近端和远端中间的中间平面721。一承载气球711包围发射元件。承载气球由诸如聚合物之类的柔性材料所制成。也可使用与在血管成形技术领域内所用的来形成非顺从性气球的材料相类似的材料，例如，PET、PETG、尼龙、聚氨酯、聚乙烯和其它的聚合物的薄膜。通常，这样的气球膨胀到一相对高的预选膨胀压力，本文中称之为“设计膨胀压力”，例如，几个大气压至10或12大气压。这种量级的膨胀压力使气球相对较硬。换句话说，当气球膨胀到设计膨胀压力时，气球呈现一预期的、预选的形状，尽管由包围的血和软组织施加的外压有变化，但与该形状的偏差极小。气球壁理想地具有抵抗设计膨胀压力而不破裂所要求的最小厚度，例如，约为0.001英寸(1密耳)或略小，较佳地约为0.5密耳或略小。
在其膨胀的结构中，承载气球具有与发射元件中心轴线724同轴的大致上为圆柱形壁的部件713。承载气球通过一孔口71与腔703连通。一透镜气球717包围在承载气球711内的发射元件720。透镜气球还具有在完全膨胀状态下的一预选的形状。透镜气球的预选形状是围绕中心轴线724的回转表面，与承载气球的圆柱形部分713以及圆柱形发射元件720同轴。透镜气球是凸出的。即，形成由透镜气球构成的回转表面的母线靠近发射元件的中间平面721处具有其最大半径。透镜气球717的内部通过一孔口719与腔701相连。
在根据本发明的另一实施例的方法中，导管的远端推进入一活体的身体内，而气球处于未膨胀状态。继续这种推进，直到发射元件和气球设置在一诸如血管之类的管状解剖学结构内，例如，遭受心房纤颤的体内的肺静脉内。在其正常状态下，肺静脉V通常不是精确圆形。例如，静脉可具有如图2中点划线所示的横截面形状。一流体通过接头705、腔701和孔口719进入透镜气球717使该透镜气球717膨胀，该流体具有比含水流体或水状流体(aqueous fluid)的声速小的声速，但具有接近水状流体声阻的声阻，该水状流体诸如是碳氟化合物。承载气球711用诸如水或盐水的水状流体充入而膨胀。
在完全膨胀状态下，承载气球711的圆柱形部分713具有比静脉V的正常的、未扩张的圆周大的圆周。因此，承载气球711的膨胀略微扩张了静脉，并将静脉壁V与全部圆柱形部分713周围的承载气球紧密接触。膨胀量并不是苛刻的。所要求的膨胀应足以保证承载气球的圆柱形表面713和所有点处的静脉壁之间保持接触，但要求不大到损害静脉壁。通常，处于膨胀状态的承载气球的圆周选定为比静脉壁的正常、未扩张圆周大5％至10％左右。当承载气球膨胀时，由于承载气球具有预选的形状，其圆柱形表面设置在离中心轴线724为一已知的预定距离，所以中心轴线和发射元件720以及透镜气球717定位在离静脉壁精确的距离处，并与静脉壁同轴。通过对在探头结构近端的连接器731施加信号，这样的信号从而可通过携带在或沿探头结构的导体(未示出)传导到发射元件，于是，启动发射单元720。发射元件再一次发射大致为圆柱形超声波，该波基本上如图1的箭头733所示沿径向传播。这些波在由透镜气球717和承载气球711内不同流体形成的界面上折射，并朝向如箭头735所示的中间平面721弯曲，因而聚焦在与中心轴线724同轴的一环形集中区域(或聚焦区)737。由于中心轴线与扩张的静脉壁同轴，所以集中区域位于与围绕静脉全部圆周的静脉壁基本上等距离处。换句话说，集中区域设置在围绕静脉的圆周上所有点处的静脉组织内大致相等的深度处。此外，声波在介于承载气球和静脉壁之间的界面上有效地偶联到组织。因此，组织在整个静脉圆周上均匀地加热。由于从整个发射元件720发出的声功率聚焦在一小的集中区域737，迅速加热在集中区域内或周围的组织，这样，就可实施摘除或其它的热处理，而对其它组织仅有最小程度的加热。
尽管前述的讨论涉及静脉壁的摘除，但应该知道，参照图1和2的上述技术可以应用于孔口的摘除，以及应用于介于孔口和静脉本身之间的过渡区域。孔口完全由心肌组织组成，而静脉完全由病人患心房纤颤情形下除去心肌组织的异常纤维之外的静脉组织组成。这些异常的纤维起作电的起始器或激发器，以产生异常的搏动，即，紊乱的搏动。该过渡区域包括心肌组织和静脉组织。不管摘除是在孔口、过渡区域还是在静脉，通常认为是要求提供完全透壁的摘除，即，通过壁完全摘除组织，从而，确信异常纤维已摘除或通过疤痕组织的阻碍完全与心脏的心肌组织隔离。
本装置和方法可用于摘除心脏和循环系统脉管组织之外的用途。例如，任何管状的内部器官可用上述同样的方式来摘除包围器官内部的组织而得到治疗。在涉及胃食管回流疾病的情形下，在食管或胃内的异常组织的治疗可将上述的装置放入胃内和/或食管内并摘除异常组织。还有，上述的技术可用来治疗包围其它管状解剖学结构的组织，例如，消化系统、呼吸系统或泌尿系统的结构。
在另一优选方法中，该装置可用来治疗良性前列腺增生(“BPH”)。在这种病例中，包围男性体内尿道的前列腺肥大而趋于使尿道狭窄。该装置可插入尿道，而超声波能量可引入到尿道外面包围前列腺组织内的环形集中区域，从而摘除前列腺并缓解肥大。从装置的中心轴线到集中区域的径向距离可这样选择，即，将集中区域放置在前列腺本身内或在包围前列腺的被膜(capsule)内。
如图3所示，承载气球可被略去。透镜气球直接承载在静脉壁V上。由于透镜气球具有一预定的形状和尺寸，它精确地位于发射元件720’的中心轴线724’上，并且以基本上与有关图1和2中的承载气球的上述相同的方式扩张组织。在此，透镜气球再一次用一流体填充，该流体诸如碳氟化合物或其它液体，它具有比含水流体的声速低的声速，但具有接近于含水流体声阻的声阻。静脉壁的组织具有类似于水和其它含水流体的声特性。因此，声波的折射发生在介于透镜气球717’和静脉壁组织之间的界面上，这样，声波以类似于参照图1和2的上述的方式聚焦在集中区域737’上。在另一变体中(图4)，透镜气球717″、发射元件720″以及中心轴线724″可通过对中结构被保持在基本上与静脉壁同轴的一位置处，对中结构例如是设置在透镜气球附近的附加的气球750和751、伞形结构或其它膨胀结构，这样，透镜气球不承载在静脉壁上。在这种结构中，折射发生在介于透镜气球717″内的流体和静脉内包围的血之间界面上。在这种结构中，静脉壁在施加超声波能量过程中仍可保持其非圆形状态，因此，在组织内的集中区域737″的深度可稍有变化。在另一变体中，介于透镜气球和静脉壁之间的空间可用另一种流体填充，例如盐水溶液。
根据本发明另一实施例的装置(图5)包括一发射元件820、透镜气球817和一外部气球811，一般类似于参照图1和2的如上所述的相应元件。然而，处于膨胀状态的透镜气球的预定形状包括一回转表面801，它基本上与发射元件和中心轴线824同轴，但它具有一凹的形状。即，回转表面801的母线在靠近发射元件820的中间平面821的位置处，具有其最小半径或离轴线824的最小距离，且表面801沿轴向离该中间平面径向向外弯曲。处于其膨胀状态的外部气球811具有类似的回转表面813的凹形。在使用中，组件定位在一诸如静脉的管状解剖学结构内。外部气球811用一具有声速小于含水流体的声速的流体填充，而透镜气球用一声速大于外部气球内的流体的声速的含水流体或其它流体填充。以类似于上述的方式，启动发射元件以发射基本上为圆柱形的超声波，该波通常如箭头833所示径向向外传播。在此，声波朝向在中间平面821上的环形聚焦束837轴向向内折射，由于容纳在这些气球内的流体之间的声速差，折射发生在介于透镜气球和承载气球之间的界面上。然而，由于在外部气球811内的流体具有的声速小于在解剖学结构内的包围血液或其它流体的声速，声波又一次在外部气球和包围组织之间的界面上折射。该折射基本上径向引导诸波，这样，诸波基本上互相平行且如箭头839所示以大致盘形图案沿基本上径向传播。因此，声波有效地辐射一深的环形区域。声波的渗透深度仅由波的衰减(因其被组织吸收)而受到限制。在这种结构中，声波不聚焦于一点或线，但还是有效地集中在一相对狭窄的轴向区域内。即使该装置的中心轴线不与静脉精确地同轴，这种结构仍可提供有效的加热。
在图5的实施例中，远离中间平面821的外部气球区域与静脉壁接触。然而，这不是必不可少的。通过参照图4的、如上所述的辅助定位结构，全部组件可保持在静脉的中心附近。在一直接比拟的结构(图6)中，透镜气球817’是凸的，且用一含水流体填充。外部气球811’也是凸的，但用一具有比水的声速大的声速的流体填充。
在上述的实施例中，装置起到引导施加的能量到一环形区域的作用。然而，在本发明的另外的实施例中，反射器结构可引导能量到不同形状的一区域。
可进行不同于摘除的热处理。例如，应用过热可提高体内特定区域内的药或其它药剂的作用。
还有，上述特殊的液体和其它材料可被具有类似性质的其它材料取代。在另一变体中，聚焦的深度可通过改变不同气球内的膨胀压力而变化。为了提高压力变化形态上的更大变化，可利用诸如弹性体材料之类的更加容易扩张或膨胀的材料来形成气球的折射区域。在另一变体中，一可膨胀的透镜的聚焦长度可以被调整，而通过改变在透镜内的流体或在包围气球内的流体的成分而维持透镜的形状不变。
在另外的变体中，在上述实施例中用来膨胀气球的液体也可用作温度控制介质。用来膨胀一气球的液体源可包括一泵，该泵用来循环液体通过一腔进入到气球的内部空间并通过另一腔抽出液体，而将气球内的液体保持在所要求的压力下。布置液体源来提供所要求温度的液体。这样，可很好地控制在解剖学结构壁上的热边界条件。所控制的温度可在正常体温之下，以保持界面的冷却并最大程度上减小或防止衬垫解剖学结构的上皮细胞的摘除。相反，一较高的边界温度促进在壁的表面或其附近的摘除。为了实现这种效应的最大化，在承载气球内的液体可维持在刚巧低于这样的温度，即，该温度使组织损害而不取决于超声波能量，例如，高达约41℃。可在其它实施例中应用类似的结构。液体循环也用作冷却超声波元件。例如，在透镜气球内的液体可以被循环和温度控制。
在本发明中使用的优选超声波转换器或发射器示于图7至10。该转换器还在悬而未决的、共同转让的、Todd Fjield等人的美国专利申请中有所介绍，该专利题为“超声波转换器”，其与本文同样日期提交，本文援引该专利发明以作参考。该发射器包括一灵敏的压电元件1702，该元件呈现为具有一外部或前部表面1704和一内部或后部表面1706的薄壁圆柱形管的形式。一电极1708形成压电元件的前表面1704，而一类似的电极1707形成后表面。为了图示清晰起见，电极的厚度在图8和10中被大大地夸大。实际上，电极较佳地由一薄金属涂层形成，例如，金属的电镀或溅射镀膜，在实际压电材料上叠加大约为几千埃(Angstroms)的厚度。一内部结构1710包括一内支承管1712和一外支承管1714。支承管1712和1714要求由金属导电的材料形成。由图10可见，内支承管1712在其一端具有一向外突出的台阶1720。一类似的台肩1722设置在相对端。外支承管1714具有一圆柱形内部孔。台肩或环1720和1722紧密地配合在外支承管的圆柱形孔内。因此，在介于台肩1720和1722之间，在支承结构长度的主要部分上有一间隙1726位于外支承管1714的内表面和内支承管1712的外表面之间。两管在台肩1720和1722处互相密封。在管子互相密封时，间隙1726充以诸如普通室内空气之类的气体。该气体永久地保持在间隙1726内。
外支承管1714在其端部具有一对向外突出的台肩1730和1732。每个台肩具有若干弧形表面1734，它们被若干平台1736所连接，这样，每个台肩通常呈现为带有圆角的正方形。弧形表面1734与支承管1714的主要部分同轴。从端视图上看，平台1736是支承管主要部分的圆柱形表面的切线。如图7所示，管状压电电气元件1702支承在台肩1732和1730的弧形表面1734上，这样，压电元件的内表面1706与支承管1714的外表面同轴，但与支承管隔开，这样，形成一呈现为管状通道1740形式的空间，该通道位于外支承管和压电元件的内部或后表面1706之间。通道1740通过在压电元件的内表面1706和在外支承管的台肩的平台1736之间形成的小间隙1742通向转换器的外部。
在操作中，空间或通道1740用一液体填充。发射器的前表面(灵敏的压电元件的前表面1704)声学上与接受来自发射器的超声波能量的介质耦合。
例如，图7-10中的发射器可用作图1所示的超声波发射器装置。在这种情形中，透镜气球717内的液体将呈现为在发射器前表面上的声介质，并能填充通道1740。理想的是，透镜流体源循环该液体，这样，液体流过通道1740。
间隙1726(图8，10)内的空气或其它气体与外支承管1714的金属材料形成一高反射性的界面1713。在操作中，发射器通过一施加于电极1707和1708之间的电势而被激励。以一预定的超声波驱动频率施加该电势，例如，约1-15MHz。通过在探头结构的近端和发射器之间延伸的若干导电体(未示出)，利用一传统的超声波频率激励器(未示出)施加电势。例如，导电体可以一个或多个微型同轴电缆的形式提供，每个电缆包括一内导体和一外导体或外套。同轴电缆的外套可焊接或粘结到外支承管上，因而电气连接到压电元件的内表面上的电极，而内导体可连接到外表面电极1708上。
表面1713(图10)的反射界面和发射器的外表面1704以及和在这两个表面之间堆叠的材料构成了共振单元。当压电材料被激励时，它一次又一次的地重复增长并沿堆叠层的前后向收缩，即，沿表面1704和1706之间的方向。超声波振动传播通过堆叠层，并在堆叠层内的各界面向前反射，以及在堆叠层的内或后表面处被表面1713的界面向前反射。在介于表面1713和1704(包括在空间1740内的液体层)之间的堆叠层内部的不同层的尺寸应这样选择，即，在激励频率下，单元是共振的，且声振动从共振单元发射，主要通过前表面1704进入到与前表面偶联的介质。这就是说，相对于界面1713，更多的能量通过在堆叠层的外表面或前表面处的界面1704。尽管在堆叠层内的诸界面处有些反射性，如限定液体通道1740的界面，但反射界面1713有效地暴露于在堆叠层内的超声波振动，因此，它对引导发射到堆叠层的前面起了显著的作用。在通道1740内的液体有效地冷却压电元件和堆叠层的其它元件。因此，转换器元件1702的前表面和后表面均得到冷却。这与传统的空气背垫的转换器形成明显的对照。这样一个转换器通常具有一直接在压电元件后表面之后的空气层，因此，及少或没有来自压电元件的后表面的热传递。令人意想不到的是，按照这种设计的发射器可将电功率转换成声功率，通过前表面发射到周围的介质中，其效率与空气背垫的发射器效率相同。然而，按照这种设计的发射器提供这种效率连同较好的热传递，因此，较之同样尺寸的相当的空气背垫的转换器，它能以相当高的功率水平进行操作。
在共振单元内不同层的材料和尺寸要求最佳化，以确保在所要求的操作频率下获得最大效率。传统的模型技术可应用于这种优化。这种技术之一是众所周知的KLM模型，在Krimholtz等人的“初级压电转换器的新型等效电路”(New EquivalentCircuits for Elementary Piezoelectric Transducers)一文中(“电子通讯”第6卷，第13期，第398-399页，1970.6.24)描述了这种模型，本文援引该发明以作参考。各层可以模型为一维单元，具有与沿堆叠层的前后方向一致的一维尺度，即径向尺度。更精确的优化可通过有限元分析和/或物理模型和试验达到。在一实施例中，在空间或通道1740内的液体形成共振单元的一体部分。
内支承管为导管、引导线或装置的其它元件提供一通过发射器的通道。内支承管和设置在其中的任何元件通过反射界面1713可有效地与在共振单元内的超声波振动隔离，因此，不影响发射器的性能。
最佳尺寸将随所要求的操作频率和使用的材料而变化。然而，一示范性的实施例使用一由陶瓷锆钛酸铅成分组成的管状压电元件，在该技术领域中称为“PZT-8”。管状转换器具有的内径为83密耳(0.083英寸；2.1毫米)，壁厚为10.5密耳(0.27毫米)，这样，压电元件的外径为103密耳(2.6毫米)。外支承管1714的外径是72密耳(1.8毫米)；且环形通道1740具有一径向厚度5.5密耳(0.14毫米)。外支承管由半硬黄铜形成，其壁厚为5密耳(0.13毫米)。介于台肩1720和1722之间的尺寸是325密耳(8.25毫米)，转换器的有效长度为8毫米。该转换器在9MHz的激励频率下提供峰值效率。当在9MHz操作时，转换器在20和100瓦之间的电力提供超过百分之五十(50％)的效率。当被速度为每分钟几毫升的水流冷却时，转换器在高达100瓦的功率水平下工作几分钟或更多一些时间，以提供大约51瓦的辐射声功率。
上述的装置可以变化。例如，装置可用来对除活体的内部器官之外的结构施加超声波能量。还有，用作一发射器的转换器也用作超声成象应用中的接收器。因此，转换器可间歇地致动，然后，用来检测来自包围装置的结构的回声。装置可设置成提供径向辐射的图形，就如参照图5所述的那样。例如，这样的装置可用于血管内超声波手术或其它的医疗应用中，或者诸如检测管道或管子的非医学应用。该装置可沿结构的长度移动，以沿结构长度扫描发射的超声波。
上述的超声波发射器可被光学发射器代替，例如，一光纤的远端设置在透镜气球内，其近端与一外部光源连接。光纤的远端设有一透镜或锥形镜，以引导光径向向外。在这种修改中，选择气球中的流体，以提供不同的光折射率，而不是提供不同的声速。
装置还包括放置气球和便于气球有序消气的结构，该结构在悬而未决、共同转让的Todd Fjield等人的美国专利申请中已有介绍，该专利题为“施加集中能量的热处理方法和装置”，该申请与本文同日期提交，本文援引该发明以作参考。在该申请中公开的其它特征也可被采纳。
可应用上述的诸特征的这些和其它变体以及诸特征的组合，上述的优选实施例的描述应被看作是对本发明的说明，而不是对本发明的限制。
工业适用范围
本发明可应用于医学和兽医的治疗，以及其它工业界。

Claims (7)

1.将超声波能施加到一活体体内组织的装置，它包括：
a)具有一发射表面的超声波发射器，发射表面呈现为绕一中心轴线的回转表面的形式；
b)一可膨胀的透镜，所述透镜具有一折射表面，折射表面呈现为当所述透镜处于膨胀状态时，绕与所述发射表面同轴的所述中心轴线并包围所述发射表面的回转表面的形式，所述透镜包围所述发射器，这样，在所述发射表面上发射的至少一些超声波能量将被导向通过所述透镜的所述折射表面进入身体的组织内；还包括一细长的探头，所述探头具有一近端和一用于插入活体的身体内的远端，所述发射器和所述可膨胀透镜安装在靠近远端的所述探头上。
2.如权利要求1所述的装置，其特征在于，所述发射表面是圆柱形的。
3.如权利要求2所述的装置，其特征在于，所述可膨胀透镜用于聚焦由所述发射器发射的超声波能量进入包围所述中心轴线的一环形集中区域。
4.如权利要求2所述的装置，其特征在于，还包括一包围所述发射器和所述透镜的承载气球，所述承载气球具有一承载表面，它用于与身体的一器官的壁接合。
5.如权利要求4所述的装置，其特征在于，操作所述承载气球以与一管状器官的壁的内表面接合，这样，所述环形集中区域位于在所述壁的环形路径的沿线上。
6.如权利要求5所述的装置，其特征在于，操作所述承载气球，以与一肺静脉的内表面接合。
7.如权利要求4所述的装置，其特征在于，所述探头包括一与所述承载气球连通的第一腔，一与所述可膨胀透镜连通的第二腔，这样，所述承载气球和所述透镜可用流体来膨胀，所述流体具有声阻抗，但具有不同的声速，由此，超声波能量将在所述的折射表面上折射。
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