CN1186420A - 同时进行超声诊断和治疗的方法和设备 - Google Patents
同时进行超声诊断和治疗的方法和设备 Download PDFInfo
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- CN1186420A CN1186420A CN96194441.2A CN96194441A CN1186420A CN 1186420 A CN1186420 A CN 1186420A CN 96194441 A CN96194441 A CN 96194441A CN 1186420 A CN1186420 A CN 1186420A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01S—RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
- G01S15/00—Systems using the reflection or reradiation of acoustic waves, e.g. sonar systems
- G01S15/88—Sonar systems specially adapted for specific applications
- G01S15/89—Sonar systems specially adapted for specific applications for mapping or imaging
- G01S15/8906—Short-range imaging systems; Acoustic microscope systems using pulse-echo techniques
- G01S15/899—Combination of imaging systems with ancillary equipment
Abstract
本发明公开了一些在使用治疗超声波的同时运行诊断超声波的方法及设备(12—102),在对患者的某个部位使用治疗超声波,使得施与该部位的囊泡破裂以增强气穴效应或靶击释放出生物活性剂的同时又进行该部位的超声成像方面,这些方法和设备(12—102)具有特殊的优越性。操作者可以实时地监视囊泡的破裂。
Description
本发明领域
本发明涉及超声诊断及治疗领域,更具体地涉及在对患者的一个部位使用超声治疗的同时进行超声诊断的新方法及设备。
本发明背景技术
超声诊断指的是使用超声换能器发生并接收超声波,使人或动物的患病部位成像。典型的情况是,换能器放在患者躯体待成像部位上面,换能器产生的超声波对准这个部位,然后换能器接收从这个部位反射回来的超声波并转换成电信号从而产生图象。通常,使用频率高、能量低的诊断用超声可得到较好的图象。也可以使用造影剂来改善超声诊断的图象质量。典型的造影剂包括如固体粒子的悬浮体乳化的液滴以及充有气体的囊泡,例如见Himann等人的美国专利N O.4,466,442及已公布的PCT专利申请WO92/17212及WO92/21382。
超声还用于多种治疗。一种公知超声治疗应用是高温治疗。高温治疗就是将组织团块,例如肿瘤作为靶体置于聚焦了的超声作用之下,对其进行加热以使团块生长减缓或缩小。如D.Arrigo的美国专利NO.5,215,680所述,可以用向被处理区域导入微泡的办法来增强超声治疗的热效应。
在已公布的PCT专利申请WO94/28873中叙述了超声治疗的另一种应用,这就是向患者施入许多囊泡,并且使用如诊断用超声监视直至在所关心部位出现囊泡,然后对该部位施加治疗用超声波以使囊泡破裂而达到治疗目的。例如,可以在囊泡上结合上一种生物活性剂,当囊泡破裂时这种生物活性剂便释放出来,从而达到向所关心部位供给生物活性剂的目的。
治疗用超声的频率典型地不同于诊断用超声。具体的说,治疗用超声使用的频率较低,以减少衰减,而诊断用超声使用频率较高,以便得到更高的清晰度。
在现有技术中曾作过努力来开发可以在进行超声治疗,特别是高温治疗的同时进行超声诊断的装置。Schaetzle等人的美国专利No.5,391,140叙述了一种装置,这种装置具有在使用治疗用声波进行局部高温治疗的同时进行超声诊断的能力。该装置使用一种包含诊断用换能器元件及治疗用换能器元件的换能器组件。诊断用换能器元件组成一个中心阵列,治疗用换能器元件环绕在该中心阵列周围。将治疗用换能器元件布置在位于中心的诊断用换能器元件的外面使得治疗用声波在高温治疗应用中能更准确地聚焦,生物组织能得到更大的加热。然而,诊断用换能器元件位于中央却限制了图象质量和清晰度。
Driller等人的美国专利No.4,484,569、Coleman等人的美国专利No.5,005,579都叙述了多种兼有超声诊断及高温超声治疗能力的装置,但二者未必能同时运行。
这些已有技术系统中所用的换能组件及系统相对地比较复杂,并且制造起来比较昂贵。此外,这些装置在能够同时进行超声诊断和超声治疗的范围内,其设计的主要目标是它们的超声治疗性能,因此仅限于在治疗用应用中使用。这些系统中没有一个适于在对患者的一个部位使用超声以使囊泡破裂,增强气穴效应或达到释放出生物活性剂的目的的同时又进行超声成像,因此需要提供具有这种能力的方法和设备。本发明满足了这种需求。
本发明概述
本发明涉及在对患者的某个部位进行超声波治疗的同时进行超声诊断的新方法和设备。具体地说,本发明的方法和设备能方便地在对患者的某个部位使用治疗用超声,使施于该部位的囊泡破裂以达到例如将结合在囊泡上的生物活性剂靶击释放的目的的同时对该部位进行超声成像。本发明的方法和设备允许操作者实时地监视囊泡的破裂。
本发明的一个方面的内容为一种超声换能组件,包括多个用来产生治疗超声波的治疗换能器元件和多个用来产生和/或接收诊断用超声波的诊断用换能器元件。治疗用及诊断用换能器元件布置在一个公共的台座上,该台座具有一基本上为平面形的上表面。治疗用换能器元件群配置在诊断用换能器元件群中央台座的平面形上表面上。诊断用换能器元件群配置在处于中央的治疗用换能器元件群的外面扩大了超声换能组件的视野,增加了该组件的成像灵敏度并提高了该超声换能组件所得到的图象的清晰度。
本发明的超声换能组件能够在对患者的一个部位使用治疗用超声的同时对该部位进行超声诊断。本发明的超声换能组件可以用于各种各样的治疗应用中,包括高温治疗、气穴治疗等等。在对施与患者的一个部位的囊泡进行超声成像的同时施与治疗用超声波,使囊泡破裂,达到诸如使结合在囊泡中的生物活性剂释放出来的目的。本发明的超声换能组件在上述方面具有特别的优越性。
本发明的另一个方面内容为一种方法,该方法即在进行超声成像同时使患者的某个部位内的囊泡在超声作用下破裂,以达到诸如增强气穴效应或使结合在囊泡中的生物活性剂释放出来的目的。该方法包括以下步骤:(1)向患者施与一定量的囊泡;(2)使患者的某个部位内的囊泡受到一定频率及能量的治疗用超声波的作用以使囊泡破裂;(3)与此同时接收来自以治疗超声波谐振频率超声作用的囊泡的超声发射并生成该部位的图象。同时成像允许操作者实时地监视囊泡的破裂。
本发明的这些性能和优越性及其它的性能和优越性在下文中会充分体现。
附图简述
结合附图将对上文中的综述及下文中的详细描述的内容有更好的理解。为了用图例来说明发明的目的,这里图示了几个优选实施例,然而应该理解,本发明的范围并不限于这些图例公开的具体方法及手段。在附图中:
图1为本发明的一个实施例的超声换能组件的部分顶视图;
图2为图1所示超声换能组件沿图1中2-2线的横截面图;
图3为图2中的超声换能组件的透视图;
图4为本发明的超声换能组件的第二实施例;
图5为一个装有本发明超声换能组件的手持单元;
图6为一同时进行超声诊断及超声治疗的设备的方框图,该设备采用了本发明的超声换能组件;
图7为一个对图6所示的电路作更详细说明的方框图;
图8为本发明的超声换能组件的第三实施例;
图9为本发明的超声换能组件的第四实施例;
图10(a)及(b)所示为一装有本发明超声换能器元件的食管内探头;
图11(a)及(b)所示为一装有本发明超声换能器元件的内腔探头;
图12(a)及(b)所示为一装有本发明超声换能器元件的内腔探头的第二种构造;而
图13所示为一装有本发明超声换能器元件的内腔探头的第三种构造。
本发明详述
本发明的目的为提供在对患者的某个部位进行超声波治疗的同时进行超声诊断的新方法及设备。具体地说,本发明的新方法和设备能方便地在对患者的某个部位使用治疗用超声,使施于该部位的囊泡破裂以达到例如将进入该部位的生物活性剂靶击释放的目的同时,对该部位进行超声成像。本发明的方法和设备允许操作者实时地监视囊泡的破裂。
本文通篇所使用的下列术语,除非另外指明,应按下述含意来理解。
“类脂”是指人工合成的或天然存在的两亲性化合物,这种两亲性化合物包含有一个亲水性部分及一个疏水性部分,类脂类的例子如包括脂肪酸、中性脂肪、磷脂、糖脂、脂族醇和蜡、萜烯、以及甾族化合物。
“类脂组合物”是包含有类脂化合物的组合物,典型的类脂组合物包括悬浮液、乳液及囊泡组合物。
“类脂制剂”是指包含有类脂化合物及生物活性剂的组合物。
“囊泡”是指一种球形体,其特征为具有一个内部空穴。囊泡最好是由类脂类配制而成,包括这里所述的各种类脂。在任何已知的囊泡中,类脂可以以单层或双层的形式存在,而单层或双层脂膜又可以组成一层或更多层的单或双层膜。在由多于一层的单或双层组成单或双层膜时,各层通常是同心的。这里所述的包含这种实体的类脂囊泡通常称作脂质体、胶团、泡沫、微泡、微球体等等。这样,类脂可以用来构成单层囊泡(由一层单或双层构成)、寡层囊泡(由约二至三层单或双层构成)或多层囊泡(由约多于三层单或双层构成)。囊泡的内部空穴可以是充满液体(例如一种含水的液体)、气体、气体的前体和/或固体或溶解物质,包括例如所需的生物活性剂。
“囊泡组合物”是指由类脂配制并含有囊泡的组合物。
“囊泡制剂”是指含有囊泡及生物活性剂的组合物。
“脂质体”是指一般为球形的两亲性化合物,包括类脂化合物的簇或聚集体,典型地由一或多个同心的层所构成。这里亦称作类脂囊泡。
“患者”是指动物,包括哺乳动物,特别是指人类。
“生物活性剂”是指一种应用在治疗与诊断中,诸如诊断患者是否有病和/或处理患者的病的物质。这里所用“生物活性剂”一词还指一种在试验器皿中和/或在动物体内有能力发挥生物活性效应的物质。生物活性剂可以是中性的、带正电荷的或带负电荷的。适用的生物活性剂的例子包括诊断剂、药品、药物、合成有机分子、蛋白质、肽、维生素、甾族化合物及基因物质,包括核苷、核苷酸及多核苷酸。
“诊断剂”是指任何一种用于诊断患者是否患有某种疾病的试剂。典型的诊断剂例如包括用于超声、磁共振成像或X射线断层照相的造影剂。
“基因物质”通常是指核苷酸及聚核苷酸,包括脱氧核糖核酸(DNA)及核糖核酸(RNA)。基因物质可以用本技术领域公知的化学合成工艺或重组技术或二者的结合来制造。DNA及RNA也可以是由人造的核苷酸构成的,且可以是单链绞合或双链绞合的。“基因物质”还指有义的和反义的DNA和RNA,即核苷酸序列与DNA和/或RNA中核苷酸特异序列的互补。
“药品”或“药物”是指任何治疗或预防用剂,是用来处理(包括预防、诊断、减缓、治疗)患者的毛病、病痛、疾病或外伤的。治疗用的肽、多肽,聚核苷酸包括在术语药品或药物之中。
“稳定材料”是指生物相容的并能在类脂组合物中促进囊泡形成的物质。这里所用的“稳定材料”一词也是指生物相容的并能增进囊泡的稳定性的物质。稳定材料可由聚合物组成。这里所用的“聚合物”一词是指由两个或更多的重复单元化学结合而成的分子。包括在“聚合物”术语里的有如二聚物,三聚物,低聚物。稳定材料亦可由非多聚物材料组成,包括如单体分子。包括在“稳定材料”定义内的还有某些这里提到的生物活性剂。稳定材料可以是中性的或是带正或负电的。在中性的稳定材料中最好的是极性材料。
“囊泡稳定性”是指充满气体的囊泡暴露在300毫米汞柱压强下约一分钟后保持住截留气体的能力。囊泡稳定性以百分比(%)来计量,即压强释放以后囊泡所保存住的气体占原存入气体量的百分比。囊泡稳定性,包括还要提到的“囊泡复原性”一词是指囊泡在压强释放以后回复到原始尺寸的能力。
“粘度”是指用诸如粘度计这样的标准的粘度测量装置测量到的流体的内摩擦。
“上升粘度”是指粘度增加大于约20%。
“非共价缔合”是指二个或多个分离的分子之间不包括共价键在内的相互作用。分子间的相互作用取决于各种因素,例如所涉及的分子的极性、所涉及分子若带有电荷,则电荷的正负因素等等。非共价缔合最好是由离子相互作用、偶极-偶极相互作用或由范德瓦尔斯力或它们共同产生的。
“离子间作用”是指两个或多个分子之间的相互作用,这些分子中的每一个都是带正电或负电荷的。这样,“离子相互作用”举例来说就是第一个带正电荷的分子与第二个带负电荷的分子之间的吸引力。典型的离子相互作用如带负电荷的稳定材料(例如基因物质)及带正电荷的类脂(例如月桂基三甲基溴化胺一类的阳离子类脂)之间的吸引力。
“偶极-偶极相互作用”一般是指两个或多个极性分子之间产生的吸引力。这样,“偶极-偶极相互作用”就是第一个极性分子的正端与第二个极性分子的负端之间的吸引力。典型的偶极-偶极相互作用如正电头部基因(例如磷脂酰胆碱中的胆碱基团)与负电原子(例如存在于多糖一类稳定材料中的氧、氮、硫一类的杂原子)之间的吸引力。“偶极-偶极相互作用”也指分子之间的氢键键合,其中一个氢原子作为桥梁介于两个分离的分子上的负电原子之间,氢原子以一个共价键结合第一分子,以静电力结合第二分子。
“范德瓦尔斯力”是指非极性分子间的以量子力学原理算得的吸引力。范德瓦尔斯力通常与由邻近分子感应引起的,并涉及电子分布变化的瞬间偶极矩有关。
如“包括生物活性剂”、“与生物活性剂结合”、“与生物活性剂相结合”等等一类的词是指生物活性剂与类脂组合物的结合。生物活性剂可以通过多种途径中的任一途径与类脂组合物相结合。例如,当类脂组合物是以囊泡组合物形式存在时,生物活性剂可以是被截入囊泡的内部空穴之中。在囊泡的层(多层)或称壁(多层壁)中含有类脂时,生物活性剂也可以通过分布于这些类脂之间的途径结合在囊泡的层(多层)或壁(多层壁)内。此外也可预料,生物活性剂可能位于囊泡的表面上。在这种情况下,生物活性剂可能与囊泡表面相互之间发生化学作用而牢牢的吸附在上面。这种相互作用可能采取例如非共价结合的方式。这种相互作用可以使囊泡保持稳定。
“涂复”或“涂布”是指稳定材料与类脂体和/或囊泡之间的相互作用,包括非共价相互作用。
“使受到声波作用”及类似的变型词是指使暴露在超声波中。
关于囊泡、囊泡组合物以及囊泡制剂,以及这三者的制造方法的其它细节载于一起在待审中、有共同受让人的,1995年4月5日申请的名称为“NOVEL COMPOSITIONS OF LIPIDS AND STABILIZINGMATERIALS”的美国专利申请No.08/417,238以及在待审中、有共同受让人的、1993年6月11日申请的名称为“NOVELTHERAPEOTIC DRUG DELIVERY SYS TEMS”的美国专利申请No.08/076,250和它的子序列专利中,这里引用这些专利的公开文件的全文作为参考。
本发明一个方面为一种超声换能组件,该超声换能组件用来在对患者的一个部位使用治疗用超声波的同时对该部位运行超声诊断。本发明的超声换能组件包括多个用来产生治疗用超声波的治疗用换能组件和多个用来产生和/或接收诊断用超声波的诊断用换能器元件。治疗用和诊断用换能器元件布置在一个公共台座上,该台座具有一个基本上为平面形的上表面。治疗用换能器元件配置在诊断用换能器元件中央台座的平面形上表面上。诊断用换能器元件配置在处于中央的治疗用换能器元件的外面,从而扩大了超声换能组件的视野,增加了该组件的成像灵敏度并提高了该超声换能组件所得到的图象的清晰度。
本发明的超声换能组件能在对患者的一个部位使用治疗用超声波的同时,将诊断用超声波施加到该部位并且接收来自该部位的诊断用超声波。本发明的超声换能组件可以用于各种各样的治疗应用中,包括高温治疗、气穴治疗等等。本发明的超声换能组件能特别方便地在使用超声使囊泡破裂以达到诸如增强气穴效应或靶击释放出结合在囊泡上的生物活性剂的目的的同时进行超声成像。使用本发明的超声换能组件,操作者可以实时地监视囊泡的破裂。
参阅附图,在所有附图中同样的元件以相同的标号表示。图1所示为依照本发明的超声换能器组件10的第一实施例的顶视图。根据第一实施例的设计,多个治疗用换能器元件为一治疗用换能器元件的线型阵列16。这里所说的“治疗用换能器元件”的意思为一种换能器元件,该换能器元件的声学性能适于产生一种超声波,这种超声波的频率与能量就是超声波治疗实践中所用的,并且该换能器元件的声学性能最好适于产生一种超声波,其频率与能量足以使体内和/或体内的囊泡破裂。线型阵列16的治疗用换能器元件产生的超声波的频率范围以约0.25-100MHz为好,约0.75-3.0MHz则更好,而最好是约1.0-2.0MHz。换能器元件产生的超声波频率部分地为换能器元件厚度的函数。
此外,按照本发明超声换能器元件第一实施例,第二多个换能器元件包括诊断用换能器元件的第一和第二两个线型阵列12和14。阵列12和14分别配置在治疗用换能器元件线型阵列16的两侧。这里所说的“诊断用换能器元件”是指一种换能器元件,其声学性能适于产生并接收诊断用超声应用(成像),包括基于谐振成像技术的声波信号。第一和第二阵列12、14的诊断用换能器元件最好应能产生并接收频率范围约1.0-10MHz的超声波。
图2为图1所示的换能组件10的截面图,该图更详细的显示了依照本发明的换能组件10。如图所示,换能器元件线型阵列12、14、16排列在一个具有基本上为平面形的上表面的公共台座18上。在本实施例中台座上表面18a的中央部分为一台阶以适应治疗用换能器元件线型阵列16厚度较大的情况。在治疗用换能器元件线型阵列16和台座18的上表面18a之间设有第一背衬材料26。在台座18的上表面18a与诊断用换能器元件的每一个线型阵列12和14之间设有第二背衬材料20。如图所示,在换能器元件各个线型阵列12、14、16的面上设有一层公共的阻抗匹配材料。
治疗用换能器元件的线型阵列16可以由操作者选择以连续波或脉冲重复频率(PRF)两个模式运行,供给治疗用换能器元件的能量可以由操作者根据处理的深度来调控。当如下文所述用来使囊泡破裂以达到治疗的目的时,治疗用换能器元件线型阵列16优选的运行能量范围为0.05-5.0W/cm2。在约0.2-2.5W/cm2之间则更好。
诊断用换能器元件的第一及第二线型阵列可以用来执行常规的成像任务并可在几个不同的模式下运行。一个模式是两个阵列12和14各自独立地运行而在两个独立的屏幕上同时各自产生图象,在这个模式下,两个阵列12、14各自传输出并接收各自的超声波。另一个运行模式是阵列12、14中的一个作为输出阵列,另一个作为接收阵列,这样所形成的是治疗用换能器元件阵列16的焦点附近区域的图象。这一模式需要常规的射束控制来适当地聚焦。
在一个优选的成像模式中(下文将联系本发明的新方法对此进行更充分的描述),治疗用换能器元件线型阵列16发出治疗用超声波,该超声波的频率和能量足以使施于患者的大量囊泡破裂,而两边的诊断用换能器元件阵列12和14用来接收超声作用下的囊泡谐振波发射,因而囊泡的破裂可被实时地成像。最好是用第一和第二阵列来接收超声波作用下的囊泡的二次谐振波发射,也就是说频率为入射治疗用超声波频率一倍的谐振波发射。不过接受入射波的其它次,包括奇数次及偶数次的谐振波发射也是可以运行的。
治疗用和诊断用换能器元件最好都用陶瓷压电材料例如锆钛酸铅(PZT)制成。其它压电材料也能使用。正如本技术领域公知那样,换能器元件的厚度和线型阵列中相邻换能器元件的中心距决定了该阵列的中心频率或谐振频率。为了得到要求的中心频率,换能器元件的厚度和相邻元件的中心距应等于该频率超声波波长的一半。例如欲得到3.5MHz的中心频率,换能器元件厚度及相邻换能器元件中心距应为2.3×10-2cm。阵列12、14、16的每个换能器元件都可以用任何常规方法制造,例如换能器元件可以用金刚钻锯从压电材料薄片上割下,也可用氢氟酸(HF)缓冲溶液蚀刻。
配置在治疗用换能器元件线型阵列16和台座18之间的第一背衬材料26的声阻抗经过优选而适于发送治疗用超声波。在本实施例中,第一背衬材料的声阻抗优选为约2×106kg/m2/s到约3×106kg/m2/s,这样大小的声阻抗适于发送前面规定的频率和能量范围的治疗用超声波。第一背衬材料可以选用众多适用材料中的任何一种。第一背衬材料最好包含有聚合物基体材料,并采用例如带有钨粉的环氧树脂牢固地粘合在治疗用换能器元件线型阵列16上。第一背衬材料26也可以选择为包含有空气的。
配置在诊断用换能器元件的两个线型阵列12和14与台座18之间的第二背衬材料20的声阻抗经过优选而适于发送和接收诊断用超声波。诊断用超声波的频率最好为1.0-10.0MHz。第二背衬材料的声阻抗最好为约7×106kg/m2/s。第二背衬材料可以选用众多适用材料中的任何一种。第二背衬材料最好包含有多聚物基体材料,并采用例如带有钨粉的环氧牢固地粘合在对应的线型阵列12、14上。第一背衬材料26的声阻抗一般低于第二背衬材料20。
匹配材料层24最好具有一个将声阻抗失配的换能器元件与患者的生物组织匹配起来的声阻抗,匹配材料24的声阻抗最好在生物组织和换能器元件之间。众多适用材料中的任何一种都可用于制作匹配层24,例如带有环氧的丙烯酸。
治疗用换能器兀件16与诊断用换能器元件12、14之间最好用一种具有强阻尼声阻抗的材料绝缘,这种材料最好位于图1和图2换能器组件10的区域17的位置。绝缘材料会降低来自治疗用换能器元件16的声学干扰,在同时进行成像时该声学干扰会在诊断用换能器元件12、14所接收的超声回波上加上一个噪声。众多的强阻尼材料可用作绝缘材料,例如氯丁橡胶或空气。
图3为图2所示的换能器组件的透视图,图中表明电极附着在线型阵列12、14、16的相应换能器元件上。每个换能器元件的底面和顶面上的电极(图中未显示)连到各自的柔性的电路板28和30上。柔性电路板28将每个换能器元件中的一个电极接地,而另一个柔性电路板30将每个换能器元件中的另一个电极接通正极。为了得到适宜的连接,可采用丝搭接或带搭接的形式。
每个线型阵列12、14、16中的元件数目不限于图1和2中表示的元件数目。图4所示为依照本发明的超声换能器组件10’的第二实施例。在第二实施例中,每个线型阵列12’、14’、16’的元件数目都增多了。每个线型阵列12’、14’、16’的换能器元件的增多的优点为增加了清晰度和具有更高的治疗输出功率。
切趾技术可以用于每个线型阵列12、14、16中。切趾法将增强对比解象能力并将消除诊断用换能器元件线性阵列12、14的旁瓣假象。切趾法也能将治疗用换能器元件线性阵列16的旁瓣假象减至最小。常规的射束控制技术可以用来使治疗用换能器元件线型阵列16的超声输出能量聚焦,同样可以用于诊断用换能器元件线型阵列12、14在发送及接收模态时的聚焦。射束控制的最大角度应保持在25度以下,这有助于将影响图象清晰度的栅瓣和旁瓣降至最小。
图5显示了一个装有本发明超声换能器组件10的手持装置。在外壳32的一端为换能器组件10。装置通过电缆36与后面将详述的超声系统相连。按钮34用来控制治疗用换能器元件线型阵列16的启动。两个诊断用换能器元件阵列12、14可以用来给待处理部位定位。一旦所要求的部位定位完毕,就可以压下按钮34使治疗用换能器元件线型阵列16启动。
本发明的超声换能器组件及图5中的手持装置最好用与磁共振成像(MRI)模式相容的非磁性材料构成。柔性电路板28、30的触点最好用铜或类似的材料制造,壳体最好用非磁性材料如不锈钢或聚合物材料制造。
图6为一用于本发明超声换能器组件10的超声系统的方框图。用户界面40用来使操作者无论是在诊断用还是在治疗状态都能以常规的方式对换能器组件的不同参数进行调控。例如操作者可以调整换能器元件的输出能量并调整所发射的能量的焦点深度。主系统控制器42可以通过一个标准的IBM PC/XT兼容板实施超声系统的总体运行的控制。
主系统控制器42向实时控制器44发出指令以建立脉冲序列及定时参数来得到操作者所要求的诊断和治疗任务输入。实时控制器44调控分别属于诊断用和治疗用换能器元件线型阵列12、14和16的常规的聚焦模块50、发送/定时模块52和脉冲发生器/接受器模块54。聚焦模块50、发送/定时模块52和脉冲发生器/接受器模块54进行声波的照准方向选择和诊断用与治疗用换能器阵列12、14和16的聚焦选择。发送/定时模块52调控脉冲发生器/接受器模块54并给出适宜的通道以形成出诊断用和治疗用换能器阵列12、14、16合用的孔径。脉冲发生器/接受器模块54在发送/定时模块52的调控下向各个换能器元件发去合适的脉冲序列。脉冲宽度、持续时间、功率、窗口尺寸及其它参数均按照操作者输入的参数受控于实时控制器44。为得到最佳的成像清晰度,焦距与窗口尺寸之比值应保持相对较低的值。
本系统以一高清晰度监视器48作为视频显示。以一个视频处理器45作为诊断用换能器阵列12、14所接收的声学回波信息的信号处理器及选择器。视频处理器产生一个模拟的经过滤波的对数压缩的声学回波信号流。该系统使用了信号前及信号后检测技术,诸如时间增益补偿,以补偿因穿透深度而造成的衰减。扫描转换器46将视频处理器45的输出转换成监视器48相容的信号以实时显示二维超声图象。
图7是图6中脉冲发生器/接受器模块54的更详细的方框图。与发送/定时模块52和聚焦模块50相连接的脉冲发生器/接收器开关56控制各个换能器元件阵列12、14、16的发送及接收操作。对于发送操作,脉冲发生器/接收器开关56给相应的脉冲驱动器62、64、66送去信号。脉冲驱动器62、64、66可以通过方框60而单独地被驱动。每个阵列12、14、16中的每个换能器元件通过对应的元件总线74、76、78而被独立地驱动。实际的电信号是通过脉冲发生器电路68、70及72供应给对应的换能器元件的。当诊断用换能器阵列12、14在接收模式工作时,接收-多路转换器80对其进行控制以“监听”回波。当诊断用换能器阵列12、14在发送模式工作时,接收-多路转换器给予增益电路82以一个开路,因此增益电路82不会毁坏。
RF滤波器83是用来从诊断用传感元件所接收的回波中选择所要求的频段的那部分。RF滤波器允许特定频段内的信号通过而阻止其它频率的声波如噪声通过。由于生物组织对于入射超声波来说犹如一个低通滤波器,当为了达到最好的穿透效果而构设一个RF滤波器时,该RF滤波器的中心频率应当设计成低于诊断用换能器元件的中心频率。
图8所示为本发明超声换能器组件84的第三实施例。在第三实施例中,治疗用换能器元件群为一个治疗用换能器元件的多路相控阵列86,多个诊断用换能器元件为一个诊断用换能器元件的多路相控阵列88。如同第一和第二实施例,治疗用换能器元件阵列86配置在公共台座上诊断用换能器元件的中央。适用的背衬和匹配材料以与前两个实施例相同的方法使用。这个实施例可以用来处理患者靠近皮肤的区域。
图9所示为本发明超声换能组件的第四实施例90。该第四实施例不同于第三实施例之处在于多个治疗用换能器元件为一治疗用换能器元件的环形阵列92。如同前几个实施例一样,治疗用换能器元件的环形阵列92配置在公共台座上诊断用换能器元件的中央。适用的背衬和匹配材料以与前几个实施例相同的方法使用。这个实施例可用来处理患者靠近皮肤和中等深度的区域。
正如本技术领域人员知道的那样,图6和图7的电路当用于第三和第四实施例的多路相控阵列换能器时必须以常规的方法进行修改。
在以上每一个实施例中,治疗用换能器元件配置在诊断用换能器元件的中央。将诊断用换能器元件放在处于中央的治疗用换能器元件的外边扩大了换能器组件的视野,增加了该组件的成像灵敏度并提高了该换能器组件所得到的图象的清晰度。
本发明的超声换能组件可以装到特制的超声探头中。操作者使用这种探头可以将换能器组件送到所关心的解剖学构造附近。用这种方法可以更容易地识别组织差异、得到更高的清晰度和更广的视野。
图10(a)和(b)所示为装有本发明的以上实施例10,10’,84,90中任何一个的换能器组件的食管内探头的不同视图,换能器元件放在探头的顶部。食管内探头可用来从食管内对组织和心脏成像。超声换能器组件可以手动旋转约180度的角度。换能器组件还能沿朝前和朝后的方向转动120度以上的角度。换能器组件还进一步能向左和向右移动/转动90度以上的角度。
图11(a)和(b)所示为装有本发明的以上实施例10,10’,84,90中任何一个的换能器组件的内腔探头的一种构形98的不同视图。图11(a)和(b)所示的内腔探头可以用于阴道内。由图11可清楚地见到换能器组件的台座形状可以根据其应用场合的特殊性来构型。
图12(a)和(b)所示为装有上述实施例中任何一个的换能器组件的内腔探头100第二种构形的不同视图。这种构形中换能器组件位于探头100的最前端。这种构形可用于阴道内或前列腺成像。
图13所示为装有上述实施例中任何一个的换能器组件的内腔探头102的第三种构形。在这种构形中,换能器组件配置在沿着围绕探头轴的圆周紧接着顶部的地方。这种构形可用于阴道内或直肠内成像。
本发明的另一个方面的内容为一种新方法,这种方法用来在对患者的一个部位使用治疗用超声波使囊泡破裂以达到诸如增强气穴效应或使结合在囊泡中的生物活性剂释放出来的目的的同时,对该部位的囊泡进行超声成像。该方法包括以下步骤:(i)向患者施于一定量的囊泡;(ii)使患者的一个部位内的囊泡受到一定频率和能量的超声治疗的作用以使囊泡破裂;(iii)与此同时接收受来自以治疗超声波谐振频率超声作用的囊泡的超声发射并生成该部位的图象。实时成像使操作者可以实时地监视囊泡的破裂。
正如本领域的技术人员看到本文就会认识到的那样,本发明的方法在实践中所使用的囊泡数量是可以在很大的范围内变动的。这里所用的“大量的囊泡”一词的意思就想要包括整个这一变动范围。
悬浮在液体中的囊泡,就象这里描述的所施于的囊泡,在超声波作用下会发射出超声能量。这一现象已经是公知的,见例如D.L.Miller著Ultrasonic Detection of Resonant Cavitation Bubbles in a Flow Tubeby their Second Harmonic Emissions”,Ultrasonics 1981,9,第217-224页。这里引用这个文件以作参考。在对入射频率作谐振时会产生超声波能量发射,本发明的方法利用这一公知的现象使得操作者可以在使用治疗用超声波以使囊泡破裂的同时对囊泡制剂中的囊泡进行成像。治疗用超声波用来使囊泡在破裂之前产生谐振发射。
在一倍于入射超声波频率上的发射称作二次谐振发射,二次谐振发射是小振幅谐振里的最强谐振发射。前面已叙述过的接收装置最好是要接收这种所谓的二次谐振发射。最好是使囊泡置于一种频率的超声波的作用之下,这种频率的超声波能够诱发出最强的二次谐振发射。此频率与囊泡的直径、弹性和密度有很密切的关系。当然,如果需要,也可以在其它的谐振频率上成像,包括奇次的和偶次的谐振频率。在美国专利No.5,410,516里叙述有在激振频率的谐振及副谐振下成像的内容,这里引用该项公开文件以作参考。
为了使囊泡破裂最好使用连续波形的治疗用超声波,虽然也可以是脉冲型的。如果采用脉冲型的,那么回波脉冲串长度一般为每次约8-20次或更多些。最好回波串长度为每次20个脉冲。
作用于囊泡的治疗用超声波的能量水平最好为约0.05w/cm2到5.0w/cm2,最好为约0.2w/cm2到2.5w/cm2。对非常小的囊泡,例如直径约0.5μm的囊泡最好使用更高频率的超声波,这是因为较小的囊泡在较高的频率时吸收超声能量的效率较高。对于皮肤及其它浅层组织最好采用外部接触的方法,但对于深部构造则使用填隙式探头或前面叙述过的内腔探头来施加声能可能更好些。
实验表明,对于连续波及选定的占空因子的超声波,当瞬时峰值空间平均强度(ISPTA)(mw/cm2)为下表中的值时囊泡开始破裂。表中所有值是在所用超声波频率为1.0MHz时取得的。数据表明,对于连续波超声,囊泡最易破裂。
占空因子 | ISPTA(mW/cm2) |
5.3% | 290 |
10.4% | 100 |
21.9% | 70 |
连续波 | 35 |
有很多输入方式适于将囊泡输入到病人体内,即肠胃外的、口服的或腹膜内的。肠胃外输入是优先采用的,它包括以下形式:静脉输入、肌肉输入、间质内输入、动脉输入、皮下输入、眼内输入、滑液内输入、包括透过表皮的透皮输入、肺吸入、采用眼科方法、舌下及颊;局部输入包括眼科的、表皮的、眼睛的、直肠的及通过吹入法自鼻孔吸入。在肠胃外输入途径中,静脉输入是最好的。
输入计量及输入模式与被处理动物的种类、体重和年龄以及是否采用特殊的治疗方法有很密切的关系。典型的做法是开始时用较小剂量,然后逐渐增加直至达到所要求的治疗效果。
患者可以是任何类型的动物,但以脊椎动物为好,哺乳动物更好,最好是人类。“患者的某个部位”意思包括整个患者或患者的一部分或患者的一个特定区域。
本发明的方法也可以在试验器皿中运行。例如,在应用于细胞培养中,可以将囊泡加到培养细胞上然后进行孵化,然后可向包含有细胞及囊泡的培养液施加治疗用超声波。
用本发明的新式超声换能器组件来执行本发明的方法是最方便的。例如,假定使用如图1的超声换能器组件10,治疗用换能器元件线性阵列16可用来以一次频率,诸如1.75MHz运行受超声作用的步骤,第一和第二诊断用换能器元件线性阵列12和14可以制成与此同时用一倍于入射频率亦即3.5MHz来接收囊泡的谐振发射。
实施例
下面的例子将进一步地描绘本发明的方法,这些例子仅是出于例证的目的,而不是用来限定所附权利要求。
实例1
对一个大腿上患有恶性软组织肉瘤的患者,静脉注射(IV)了5毫升含有5毫克阿霉素的浓度为每毫升1.5×109囊泡的囊泡制剂,以诊断用换能器元件群对患者的肿块作超声成像。当囊泡通过肿块的微脉管系统时以一定灰度级成像和用彩色多普勒进行检测。在检测的时候以频率为1.5MHz、能量为0.5W/cm2的连续型超声波施加脉冲群10秒钟,以诊断用换能器元件群接收来自囊泡的频率为3.0MHz即一倍于入射的治疗用超声频率的二次谐振发射。当囊泡破裂时,阿霉素在肿块内部局部地释放出来。用本发明的方法及没备同时进行的成像使得医生可以实时地监视囊泡的破裂。当肿块内部达到了化学治疗所需要的高药物浓度后患者的肿块即得到根除。
实例2
对一个胸部患有癌的患者,通过静脉注射5毫升含有全氟戊烷囊泡的囊泡制剂,囊泡制剂中的囊泡由胸癌表位抗体标记。约48小时后进行腋窝超声成像,用治疗用换能器元件群以一个不足以使囊泡破裂但足以引起二次谐振发射的频率产生超声波。当接到从带有抗体囊泡的淋巴结节发出的二次谐振发射时即将治疗用超声波能量提高到5.0W/CM2。肿块与囊泡相偶合降低了气穴门限,在结节内发生了足以摧毁恶性肿块的气穴。通过诊断用换能器元件群能同时对毁灭过程成像。
实例3
除了囊泡还含有1.0mg/ml的顺铂以外,其它同实例2。以一0.5W/cm2的较低能量来使囊泡破裂并在淋巴结节中释放出顺铂来破坏肿块。
实例4
对一个患有心肌缺血,包括左前壁局部缺血的患者通过静脉注射2毫升含有内皮因子(EFG)基因的阳离子囊泡(1.0×109囊泡/毫升),向左心室前壁心肌施加能量为0.05-0.2W/cm2的连续波型的治疗用超声波脉冲群。当囊泡通过前壁心肌组织的微脉管系统时囊泡即破裂囊泡的破裂不但将基因释放到心肌中,而且产生局部的冲击波以促进基因物质进入心脏的内皮及心肌细胞中,这些地方获得EFG基因后结果是新的冠状循环生成,增加了冠状血流量。通过诊断用换能器元件群来接收二次谐振发射以实时地监视囊泡的破裂。
实例5
对一个患有局部侵入性食管癌的患者作含有丝裂霉素-C及BCL-2基因的囊泡处理,将一个如图10(a)和(b)所示的食道内用换能器探头放入食管内部,换能器探头的位置通过诊断用换能器元件群来确定。通过静脉注射10.0毫升带有药物和基因物质的囊泡制剂。当囊泡经过肿块时即在0.5w/cm2的治疗用超声波脉冲群的作用下破裂,囊泡的破裂受到实时的监视。治疗效果为肿块消除。
实例6
除了患者患的是胰腺癌以外,其它同实例5。换能器组件放在胃内并定位在能透过胃的后壁进行成像的位置上。胰腺癌定位后,如例5那样注入囊泡制剂,然后同时进行治疗和囊泡破裂情况的成像,患者的胰腺癌病情得到了缓和。
实例7
一个患有动脉粥样硬化的患者,施于5.0毫升的囊泡制剂,囊泡制剂中囊泡的直径小于1.0微米,并含有胆甾醇。囊泡积存在类脂体堆积斑点区域内,然后以5w/cm2的能量进行透皮的超声波治疗。囊泡破裂后将脂斑溶化。囊泡的破裂受到实时的监视。
实例8
除了囊泡施于被低密度脂蛋白(LPL)标记的动脉粥样硬化斑外,其它同实例7。
实例9
除了使用基本成纤维细胞生长因子的反义构造来消除内膜细胞增生和变窄外,其它同实例7。
实例10
除了使用一个装有超声换能组件的脉管内导管外,其它与实例7和实例8相同。当装在脉管内导管上的治疗用换能器元件在脉管内运行时,积存在动脉斑点内的囊泡便破裂。
实例11
一个患有前列腺癌的患者,通过静脉注射10毫升囊泡制剂,这10毫升囊泡制剂中含有10毫克反促黄体激素释放因子(Anti LHRH)十肽菌素。一个带有本发明超声换能器组件的直肠内探头放进患者的直肠内并通过诊断用换能器元件的帮助定位在前列腺附近。当探测到囊泡已经经过前列腺肿块的微脉管系统时便施加高能量的治疗用超声波,囊泡随之破裂,释放出局部高浓度的抑制肽。通过二次谐振发射对囊泡进行实时成像。这个门诊患者肿块退缩,侵袭进程降至最小。
本文件所引证或叙述过的每一项专利、专利申请及出版物,他们都被全文引入于此以作参考。
如同前面说明,本发明涉及在对患者的某个部位使用治疗用超声波的同时运行诊断用超声波的新方法和设备,具体地说,本发明的方法和设备能方便地在对患者的一个部位使用治疗用超声波,使施入该部位的囊泡破裂以达到例如将结合在囊泡上的生物活性剂靶击释放的治疗目的的同时,对该部位进行超声成像。本发明的方法和设备允许操作者实时地监视囊泡的破裂。可以理解,对上面所描述的诸多实施例可以作出一些并不离开本发明的较宽概念范围的变动,因此,本发明的范围并不限于已公开的诸多特定实施例的内容,本发明的权利要求书中将覆盖所有这些在本发明的概念范围内的修改。
Claims (27)
1.用来同时施加诊断和治疗用超声波的超声换能器组件,包括:
多个用来发生治疗用超声波的治疗换能器元件;
多个用来发生和接收诊断用超声波的诊断换能器元件;以及
具有基本上为平面形的上表面的台座,在该上表面上排列有所述多个治疗和诊断用换能器元件,所述多个治疗换能器元件配置在所述多个诊断换能器元件的所述平面形表面中央。
2.如权利要求1的超声换能器组件,还包括配置在所述多个治疗换能器元件和所述台座的平面形表面之间的第一背衬材料,及配置在所述多个诊断换能器元件和所述台座的平面形表面之间的第二背衬材料。
3.如权利要求2的超声换能器组件,其中所述第一背衬材料比所述第二背衬材料具有较低的声阻抗。
4.如权利要求2的超声换能器组件,其中所述第一背衬材料的声阻抗在约2×106kg/m2/s到3×106kg/m2/s范围内。
5.如权利要求2的超声换能器组件,其中所述第二背衬材料的声阻抗约为7×106kg/m2/s。
6.如权利要求2的超声换能器组件,其中所述第一和第二背衬材料都是由聚合物基体材料组成的。
7.如权利要求2的超声换能器组件,其中所述第一背衬材料包括有带有钨粉的环氧(树脂)和空气二者中的一个。
8.如权利要求2的超声换能器组件,其中所述第二背衬材料包括有带有钨粉的环氧(树脂)。
9.如权利要求1的超声换能器组件,其中所述多个治疗用换能器元件以强阻尼声阻抗材料与所述平面形表面上的所述多个诊断换能器元件绝缘。
10.如权利要求9的超声换能器组件,其中所述声学绝缘材料包括氯丁橡胶和空气二者中的一个。
11.如权利要求1的超声换能器组件,其中所述多个治疗换能器元件包括治疗换能器元件线型阵列,其中所述多个诊断换能器元件包括配置在所述治疗换能器元件所述线型阵列相对两侧的第一和第二诊断换能器元件线型阵列。
12.如权利要求1的超声换能器组件,其中所述多个治疗换能器元件包括治疗换能器元件的多路相控阵列,而所述诊断换能器元件包括在所述平面形表面上围绕在治疗换能器元件多路相控阵列四周的诊断换能器元件多路相控阵列。
13.如权利要求1的超声换能器组件,其中所述多个治疗换能器元件包括治疗换能器元件的环形阵列,而所述多个诊断换能器元件包括在所述平面形表面上围绕治疗换能器元件环形阵列四周的诊断换能器元件多路相控阵列。
14.如权利要求1的超声换能器组件,还包括一层配置在所述治疗和诊断换能器元件上与所述台座相对一侧表面上的阻抗匹配材料。
15.一种对患者进行治疗的方法,包括的步骤为:
(i)向患者施用一定数量的囊泡;
(ii)使患者的某个部位内的囊泡受到一定频率和能量的治疗超声波的作用以使囊泡破裂;以及
(iii)与此同时,接收来自以超声波谐振频率超声作用的囊泡的超声发射并生成该部位的图象。
16.如权利要求15的方法,其中治疗超声波包括连续波型超声信号。
17.如权利要求15的方法,其中治疗用超声波是脉冲型的。
18.如权利要求15的方法,其中所述囊泡的超声发射所接收的谐振包括对所述治疗超声波频率的二次谐振。
19.如权利要求15的方法,其中所述图象是实时生成的。
20.如权利要求15的方法,还包括使用诊断超声波来监视囊泡以确定在所述部位里囊泡是否存在的步骤,该步骤在所述的使囊泡受到超声波作用步骤以前进行。
21.如权利要求15的方法,其中囊泡是通过静脉施用的。
22.如权利要求15的方法,其中囊泡结合有生物活性剂而形成囊泡制剂,囊泡破裂便导致向所述部位释放生物活性剂。
23.如权利要求15的方法,其中所述的使囊泡受到超声作用的步骤是以多个治疗换能器元件来执行的,而所述接收步骤是以多个诊断换能器元件来同时执行的,其中多个治疗换能器元件位于其平面上的多个诊断换能器元件的中央。
24.如权利要求15的方法,其中治疗超声波的频率在约0.75到约3.0MHz范围内。
25.如权利要求24的方法,其中治疗超声波的频率在约1.0到约2.0MHz范围内。
26.如权利要求15的方法,其中所述治疗超声波的能量在约0.05到约5.0W/cm2范围内。
27.如权利要求26的方法,其中所述治疗超声波的能量在约0.2到约2.5W/cm2范围内。
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JP2007289693A (ja) | 2007-11-08 |
US5558092A (en) | 1996-09-24 |
WO1996039079A1 (en) | 1996-12-12 |
JPH11506636A (ja) | 1999-06-15 |
CA2220756A1 (en) | 1996-12-12 |
AU711788B2 (en) | 1999-10-21 |
EP0836420A1 (en) | 1998-04-22 |
AU5875696A (en) | 1996-12-24 |
EP0836420A4 (en) | 1999-12-08 |
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