CN1901837B - 组成式超声波换能器 - Google Patents

组成式超声波换能器 Download PDF

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CN1901837B
CN1901837B CN2004800393289A CN200480039328A CN1901837B CN 1901837 B CN1901837 B CN 1901837B CN 2004800393289 A CN2004800393289 A CN 2004800393289A CN 200480039328 A CN200480039328 A CN 200480039328A CN 1901837 B CN1901837 B CN 1901837B
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transducer
frequency
ultrasonic transducer
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energy converter
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J·U·奎斯特盖德
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Solta Medical Inc
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    • B06—GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS IN GENERAL
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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
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Abstract

描述了具有多个聚焦区的超声波换能器。在一个实施例中，超声波换能器被制成为单件，但是具有两个或多个聚焦区。在第二个实施例中，超声波组件结合了高频和低频换能器。在第三个实施例中，可互换的组件允许基于手术要求使用不同的超声波换能器。同时也揭示了各个实施例的变型。

Description

组成式超声波换能器
与相关申请的交叉应用
本申请要求2003年12月30日提交的第60/534,034号临时申请(代理人案号021356-001300US)的权益，其全部公开通过引用包括在此。
本申请的主题涉及以下申请的主题：题为“医疗设备联机脱气装置”的10/750,370(代理人案号02356-000500US)；题为“用于医疗手术的关节式臂杆”的10/751,344(代理人案号02356-000600US)；题为“一次性换能器密封”的10/750,369(代理人案号02356-000700US)；题为“位置跟踪设备”的60/533,528(代理人案号021356-000900US)；题为“用于计划和进行超声波疗法的方法”的60/533,988(代理人案号021356-001000US)；题为“采用罩运动控制的超声波疗法”的60/534,036(代理人案号021356-001100US)；和题为“用于破坏脂肪组织的系统和方法”的60/533,958(代理人案号021356-001200US)；这些申请的全部公开通过引用包括在此。
发明背景
1.技术领域本发明涉及在没有侵害成分的情况下通过将超声波能量投射在脂肪组织中来破坏脂肪组织的超声波换能器设备。特别是，本发明详细说明了具有多个焦点的换能器，或使用多个换能器进行非侵害脂肪组织破坏的设备。
2.现有技术描述塑身已经发展成为减轻人的体重和重塑苗条匀称体形所强烈追求的方法。随着工具和技术的发展，整形外科方法的范围已经得到巨大扩展。既能快速减轻体重又能塑身的多种流行方法之一是吸脂术。
吸脂术是一种通过造型和去除不需要的脂肪能够极大改善不同身体部位的形状和外形的身体造型方法。每年要进行200,000件以上的吸脂手术。吸脂术领域的最新创新和改进包括肿胀术和超声波辅助技术。传统的吸脂术通过在所需位置做一个小切口、然后在脂肪层中的皮肤下面插入空心管或插管来完成。插管与真空装置连接，脂肪在高抽吸压力下被吸出。该方法不加区别地除去了脂肪、结缔组织、血管和神经组织。并且，该方法会导致流血、碰伤、外伤和失血，限制了可能除去的脂肪量。
肿胀术允许在少量失血的手术过程中去除极多的脂肪。肿胀吸脂术在抽吸之前将大量盐水和肾上腺素溶液注入脂肪层。再使用插管和抽吸设备除去脂肪。该方法减少了传统吸脂术的出血。但是，该方法仍然除去了大量结构组织、血液和神经末梢。
最新被核准的发明是超声波辅助吸脂术(UAL)。UAL采用了端部以超声波频率振动的钛插管。振动破坏了近体的(near volume)脂肪细胞并基本上溶解了它们，以便于去除。UAL使用低功率抽吸，并只吸引插管端部附近的脂肪物质。该技术对诸组织而言更加精细柔和，失血更少、碰伤更少、疼痛减轻且恢复要快得多。
用于外科手术的超声波应用不限于UAL。有人已将高强度聚焦的超声波(HIFU)技术用于癌症治疗。
Cain等人的第6,309,355号美国专利揭示了一种在靶组织中产生微气泡、然后使用超声源使微气泡产生空穴效应来破坏附近组织的方法。优选实施例采用了低频(小于500kHz)超声源以产生空穴。一种诊断仪器被用来确定各个外科损伤的位置。
Eshel等人的PCT申请WO 02/054018 A2提供了在同时不溶解非脂肪组织的同时溶解人体部位的脂肪组织的方法。该方法描述了在身体中使用耦合到诊断成像系统和计算机的HIFU以跟踪被HIFU能量照射的区域。
以下附加的参考文献与该技术有关：5,769,790；6,113,558；5,827,204；5,143,063；5,219,401；5,419,761；5,618,275；6,039,048；6,425,867；5,928,169；6,387,380；6,350,245；6,241,753；5,526,815；6,071,239；5,143,063和WO 00/36982。
当前使用高强度聚焦超声波(HIFU)通过空穴效应在生物组织中形成损伤的方法有许多实际限制。为达到空穴所需的强度，以前的工作通常涉及使用相对低的(即小于1.5MHz)频率和相当高的(即大于50瓦特)输出能量的物理上大的(即直径大于2cm，通常在5cm到10cm范围之间)聚焦换能器。低频通常要求大换能器和高功率电平，以便在能量足够用于空穴的换能器的焦点处达到局部强度。低频，甚至接近声频(即20KHz)对空穴效应可以是较佳的。物理上大的换能器出于某些原因实际上限制了临床应用。
通常，必须在大换能器的整个作用面和患者之间保持物理接触。该接触常常是通过耦合材料来保持，以便完全将超声能量传入靶组织。由于组织自然的外形，较大的换能器要保持完全耦合较为困难。理想地，在换能器和形成损伤的焦点体积之间没有造成大的声学特性不连续(引起反射、折射等)的中介介质。为使整个口径避免可能会劣化或破坏正确聚焦能力的诸如骨头或气孔之类的中介介质，较大的换能器更加难以定位。此外，焦深极浅的大换能器很困难，即使不是不可能制造或正确地应用。焦深与口径尺寸的典型比率不小于1(f/l设计)。即使该比率可被物理地减小，由于临界角效应，声耦合也会有问题。传输线固定器(standoff)可被用来在保持耦合的同时物理地将换能器从靶组织移开，但是在组织表面增加强度和简单地易于在物理上使用方面存有缺点。
此外，每一换能器的焦点在皮肤表面下处于固定的深度，用户不能调节使用固定焦距的换能器来破坏脂肪组织。换能器是用特定的频率、幅度、焦深和功率来制造，而在制造过程完成之后，这些变量不能被改变。结果是，试图利用高强度聚焦超声波通过加热、空穴或二者的某些结合来产生对脂肪组织的破坏的方法被限制于在特定的组织深度操作，并且除了更换换能器之外，不能对换能器参数做哪怕是轻微的调节。因此，若患者希望处理大量脂肪组织，以致要经常要求采用吸脂术方法，而高强度聚焦超声波设备将不能处理作为手术变量的深度和宽度。因此，高强度聚焦超声波方法对患者而言不再是较好的选择，因为效果限制于在皮肤表面下固定深度的薄层脂肪组织。
尽管已经改善了吸脂术方法且非侵害的技术和设备处于开发中，仍然要求超声波换能器能够产生所需的损伤形成以在短照射时间内使有效脂解治疗最大化。
要求换能器具备适应不同操作要求的自适应能力，这些要求涉及到频率、功率输出和作用时间的变化。
还要求换能器设备在对不会产生皮肤烧伤的情况下能够将高强度聚焦超声波传递给患者。
发明内容
因此，本发明的一个目的是提供一种能够将高强度超声波能量同时射入两个或更多聚焦区的换能器。
本发明的另一目的是提供一种能够将两个或更多不同频率聚焦到单个聚焦区中或一群聚焦区中的换能器。
本发明的另一目的是提供一种能够响应不同治疗要求的需求的自适应换能器设备。
本发明的再一目的是提供一种在经受脂解治疗的患者表皮上将消除皮肤烧伤风险的换能器。
这些目的中的至少一个在超声波换能器分割成两个或多个相等尺寸部件时被实现，其中每一所述部件具有分立的焦点。
本发明的另一实施例是换能器组件包括以高频工作而在脂肪组织中形成气泡构造的第一聚焦超声波换能器和以低频工作使得由第一超声波换能器形成的气泡破裂的第二换能器。
再一个实施例是包括具有多个插口的插座的可互换的电子医疗仪器组件。存在着具有适用于接合多个插口的公共型电子通信插头的多种电子医疗仪器。这多种电子医疗仪器中的每一种都具有电子标识。医疗器具在操作上连接到插座，并至少具有一个信号发生器、数据I/O总线和电源，其中在插头与插口接合时，医疗器具通过电子通信插头能够检测和识别每一台电子医疗仪器。该医疗器具根据一组工作参数能够控制每一台电子医疗仪器。
电子医疗设备可以是超声波换能器、传感器或其它电子可控的医疗设备。
附图简述
图1示出了分割聚焦换能器的示意图。
图2A-D示出了具有公共焦点的各种分割聚焦换能器。
图3A-D示出了具有两个或更多焦点的分割聚焦换能器。
图4A-C示出了具有用于组成式换能器的插座的系统。
图5A-B示出了各种插座和零件类型。
具体实施方式
本发明的超声波换能器可以是固定或可变幅度的超声波设备。计算机被用来控制波形发生器或放大器。来自波形发生器和放大器的信号控制换能器的操作。用户可通过计算机对从波形发生器或放大器输出的信号编程。如果诸零件具有独立的控制元件，波形发生器和放大器的直接控制是可能的。成像换能器可以和高强度聚焦超声波(HFU)换能器一起使用。成像换能器可以是简单的A线换能器，或者是采用了发射和接收波束生成器的更复杂的成像设备。在本发明中使用的诊断和治疗换能器的范围可以从单个固定聚焦元件到被电子操纵以在靶组织内产生合成的传播图形和效果的换能器阵列。
类似地，当我们讨论为换能器的电子医疗仪器时，产生超声波并具有独立的电子标识的每一医疗仪器都是用于本发明目的单个换能器.在讨论现有技术的换能器时不应用所提供的限制性定义.该定义是用来区别如下所述一起使用的多个换能器所必需的.此外，描述包括对换能器的“元件”和换能器“部件”的引用.关于“元件”，我们是指从换能器所使用的单个模片中切割的分割物.每一“元件”由波束生成器、信号发生器或简单的放大器单独控制或成组控制.相反，“部件”指作为单个换能器操作的一个或多个元件.虽然利用单个换能器同时产生多个聚焦区和波形的相控阵在理论上是可行的，但是在本文中“部件”的描述是指与另一部件分开控制的换能器，或物理上分开集合的元件.用这种方式，可同时控制多个换能器部件以产生独立的聚焦区和/或波形.
在本发明的第一实施例中，具有分成两个或多个相等尺寸部件的超声波换能器，其中每一部件具有分立的焦点。换能器可以是半球形设计或扁平的环形阵列。该换能器分成两等份和四等份。取决于需要聚焦进入靶区域的能量的大小，可减少独立元件的数量，增加换能器被分割的分割物的数量。这连同单个换能器中固定数量的元件，换能器可分割成和所需要或期望一样多的分割物。然后对每一分割物进行定形或操纵，以具有部件之间彼此不同的分立的聚焦区。可沿着换能器的轴将聚焦区叠层在彼此的顶部，或分布在换能器前面空间的三维体积中。用这种方式，来自换能器的能量可以在同一时间被聚焦成几个点。
每当分割聚焦换能器将超声能量发射进组织时，组织每次将在多于一个的焦点体积中经受所需的超声波效应。取决于换能器分割物的形状，或来自每一分割物的发射方向，可处理变化数量的深度或单个深度处更宽阔的面积或二者的组合。
在换能器的制造过程中，可将换能器制成单个聚焦换能器，然后精确地切割成多个分割物，而后这多个分割物被重新结合，使得每一部件的焦点按照需要来分布。这需要重新结合彼此处于不同高度或角度的多个换能器分割物的足够能力，以产生所需的焦点分布。
在本发明的第二实施例中，存在着具有工作在第一频率的第一聚焦超声波换能器和以第二频率工作的第二换能器的换能器组件。在使用过程中，第一换能器发射聚焦的超声能量并在焦点区内产生空穴。响应第一换能器以及所产生的超声频率，微气泡形成在脂肪组织中。第二换能器工作在更低的频率，并且用聚焦的方式或未聚焦的方式传播进入患者的组织。如果聚焦，则第二换能器具有与第一换能器的焦点区重叠的焦点区。第二换能器的焦点区可以比第一换能器的焦点区更大，以为第一换能器的重叠体积提供一定的安全余量。第二换能器的频率被设计成使由第一换能器所产生的气泡破裂。用这种方式，第一换能器可以用脉冲或连续模式发射进入患者，而气泡一形成，第二换能器就迫使它们破裂。
当每一气泡破裂时，气泡的破裂产生微量的极热耗散。结果在一定量的组织中建立的气泡将释放足够的能量，以进行局部细胞群体的加热坏死。然而，因为加热是由微气泡破裂产生而非来自使用超声波换能器的热传递，所以没有由于热换能器或过度加热组织的局部体积以产生所需结果所引起的烧伤患者皮肤的风险。从而，取代了采用简单地加热组织到期望温度所需的传统上较长的时间周期，加热坏死可在极短的时间间隔内完成。
来自空穴的物理损害效应可通过采用压缩波主动使气泡破裂来增强，这已经有一段时间为人所知了。这里的气泡使用第一换能器来形成而用第二换能器来破裂。使气泡形成的第一信号是能够被精确定位的高频换能器(例如＞1MHz)波。第二换能器通过发射低频超声波(例如＜1MHz)可产生破裂波。低频超声波可以是聚焦的或可以是未聚焦的，因此低频超声波涌入了高频换能器所聚焦的空间体积。
换能器组件的高频换能器由电子可控的信号发生器来驱动.这用脉冲或连续形式提供了1到1000瓦特声能量的传递.换能器组件的低频换能器可以是聚焦的或未聚焦的，并且由准许用脉冲或连续形式传递1到1000瓦特声能量的信号发生器来驱动或通过其进行电子控制.该高频信号发生器形成了高频子系统，并且用短脉冲持续时间(小于100ms)以高功率(例如大于100瓦特)工作.低频信号发生器形成了低频子系统，并且优选以脉冲模式工作.低频子系统优选用短脉冲持续时间以更高的功率来工作，迫使由高频换能器形成的气泡破裂.由气泡破裂所释放的强烈的能量损害了组织，以获得所需的坏死效应.
在本发明的另一实施例中，具有包括三种类型零件的可互换的电子仪器组件。首先是具有多个插口的插座。其次是具有适用于接合多个插口的公共型电子通信插头的多个电子医疗仪器，每一电子医疗仪器具有电子标识。第三是与插座进行电子通信并至少具有一个信号发生器、数据I/O总线和电源的医疗器具。该医疗器具在仪器与插口接合时能够通过电子通信插头检测和识别每一电子医疗仪器。该医疗器具能够根据一组工作参数来控制每一电子医疗仪器。
该实施例提供了能够接受不同医疗仪器的可互换设备。插座被定形为具有两个或更多插口。该插口是统一设计的，以增强诸构件的可互换能力。电子医疗仪器可以是换能器、传感器(诸如热、电和光传感器)、导向装置或检测仪器。每一仪器具有插口端和自由端。医疗仪器的插口端是统一设计的，以使它们可在插口之间被互换使用。电子医疗仪器各自包含所需的电子设备，只要它们接收到来自医疗器具的命令或供电就可以工作。在插口接合到每一电子医疗仪器的插头时，医疗器具询问插入到插座中的每一仪器。医疗仪器响应该询问，对医疗器具电子地识别自身。于是医疗器具知道什么样的元件和能力的组合出现在插座中。
因此，将多个换能器用作电子医疗仪器可起到分割聚焦或多点聚焦换能器的作用。具有不同焦深或不同工作频率的每一换能器被插入插座。医疗器具可自动确定存在哪些换能器并自动控制超声波的治疗分布。
设计成在脂肪组织中产生空穴的多个换能器可以和插座一起使用。在一个替换实施例中，工作在不同频率的多个小换能器可以聚焦到一公共焦点。重叠频率的作用通过拍频效应产生所需的空穴。因此，第一换能器可具有第一频率X1，而第二换能器可具有第二频率X2。两种频率在公共焦点的组合产生空穴，并消除了热量累积和在患者的表面烧伤的风险。可采用附加频率的换能器，以在和插座一起构成的多个物理元件之间进一步分散气泡形成作用。结合多个单独可互换的仪器使用如前所述的分割聚焦换能器，允许多个焦点区被治疗，同时保持了无害的能量透过患者直到超声束会聚在所需的聚焦区的优点。
在再一个实施例中，可互换的电子医疗仪器组件可使用第一成像换能器帮助医师将超声能量射入脂肪组织，并可使用第二治疗换能器在脂肪组织中建立空穴。第二换能器可由附加的换能器来支持，以提供高、低频组合效应，或使用一个或多个分割聚焦换能器在一次传播中覆盖更大量的脂肪组织。
现在转到附图。图1提供了本发明的简单示意图。示出了具有三个组成换能器602、604和606的换能器组件600。三个组成换能器聚焦到单个焦点630。各换能器分别具有放大器612、614和616以及与放大器相关联的频率发生器622、624和626。尽管例图显示有配备所需电子设备的三个换能器，但本发明并不限于三个换能器。如下文所示，附加的换能器和聚焦区以近似任何组合都是可能的。
在图2A-D中示出了替换实施例.第一分割聚焦平面超声波换能器如图2A和2B所示，具有中央换能器1602和环状换能器1604.第一换能器1602聚焦在第一焦点1602f，而环状换能器聚焦在第二焦点1604f上.两个换能器的频率最好不同，在聚焦区产生干扰效应.在本发明范围内也允许其它变化，如第一换能器可以是成像换能器，而环状换能器可以是治疗设备.
此外，在单个组件中使用附加的换能器频率和聚焦区允许手术结果有大量差异。在图2C和2D中示出了单个组件中的三个相等尺寸的换能器。在这里可以看出，尽管有三个面积近似相等的分隔物，但它们的形状不需要相同。这在要在聚焦区产生的信号干扰方面允许大的合成。未获得相同的效果。该信号干扰允许来自换能器的较低能量的信号发射。用这种方式，沿着每一换能器发射路径的组织暴露于比使用单一频率和幅度的换能器危险性更小的辐射能量中。本发明的换能器阵列允许低能量区在单个有效焦点区域1630中达到顶峰(图2D)。
可使换能器1602、1604和1606的各种频率提供治疗效果。例如，第一换能器1602可以是允许医师查看焦点630被投射的组织的成像换能器。第二换能器可以是试图在聚焦区位置的组织中产生空穴的高能量高频设备。第三换能器可以是具有焦点或宽阔焦点范围的较低能量的换能器。低频换能器将提供声波以使由第二换能器所产生的气泡破裂，并在能够导致细胞坏死的瞬时高温下产生微穴。
或者，具有两个部件的分割聚焦换能器2600(图3A)可以被装配成将能量辐射在两个分立的聚焦区域2602f和2604f中的单个换能器。换能器组件3600可被进一步细分为部件3602、3604、3606和3608，以产生附加的分立聚焦区3602f、3604f、3606f和3608f(图3B)。组件3600可被用来沿笔直的垂直轴(相对于换能器面，图3C)投射所有的聚焦区，或被安排成用三维图形方式展开(图3D)。
单个分割聚焦传感器仍然有不能够“在空中”适应多种医疗手术的局限性。自适应HIFU设备(图4A-C)具有包含两个或更多插口641xl-xn的插座640。在该插座内的插口在尺寸和形状方面是一致的，允许每一插口容纳对该插口类型具有相应插头的任何医疗设备(图5A-5B)。插座与医疗器具400相连接，医疗器具400具有一装入插座就控制HIFU设备的处理器和一套程序。这些模块化医疗设备中的每一个都可以被安装到插口中，并且便于去除。较佳的是，可互换换能器元件602、604、606可以用这样的方式接合插口，即换能器元件在使用过程中是固定的且牢固地安装在插口内。但是，在需要时，通过使操作者将它们拔出，它们很容易去除。各换能器元件602、604、606包含识别芯片或电路元件。只要元件被插进插口，识别芯片允许医疗器具询问每一个可互换的换能器元件。响应于该询问，换能器元件就用响应代码识别自己。响应代码可用在给医疗器具提供有关换能器元件信息(诸如频率、焦深、幅度等)的查阅表中。医疗器具现在可使用来自每一可互换元件的信息来识别换能器元件能做何种组合。这允许可互换换能器元件和医疗器具用作具有不同焦深和焦点区的分割聚焦换能器。它还允许随时改变换能器元件，以使换能器适应宽泛范围的治疗条件和要求。
尽管上面的描述涉及本发明的特定实施例，应理解的是，在不背离本发明的精神的情况下，可做出许多修改。所附的权利要求书试图覆盖这样的修改，只要它们落入本发明的真实范围和精神内。

Claims (5)

1.一种医疗超声波系统，包括：
具有工作在高于1MHz频率的第一聚焦超声波换能器和工作在低于1MHz频率的第二超声波换能器的换能器组件；以及
高频信号发生器和低频信号发生器，所述高频信号发生器形成用于驱动所述第一聚焦超声波换能器的高频子系统，所述高频子系统用小于100ms的脉冲持续时间以大于100瓦特且不大于1000瓦特的功率工作，所述低频信号发生器形成低频子系统，所述低频信号发生器驱动所述第二超声波换能器；
其中所述第一聚焦超声波换能器和所述第二超声波换能器一起工作，以便所述第一聚焦超声波换能器造成气泡而所述第二超声波换能器导致所述气泡破裂。
2.如权利要求1所述的系统，其特征在于，所述第一聚焦超声波换能器和所述第二超声波换能器能在1到1000瓦特之间操作。
3.如权利要求1所述的系统，其特征在于，所述第二超声波换能器是未聚焦的。
4.如权利要求1所述的系统，其特征在于，所述第一聚焦超声波换能器和所述第二超声波换能器是脉冲波换能器。
5.如权利要求1所述的系统，其特征在于，所述第二超声波换能器是聚焦的。
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