CN108348772A - 用于治疗脑组织的组织摧毁术治疗系统和方法 - Google Patents
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Abstract
提供一种配置用于治疗脑组织的组织摧毁术治疗系统,其可包括任何数量的特征。在一个实施例中,该系统包括超声治疗换能器、引流导管以及设置在引流导管中的多个压电传感器。超声治疗被配置成将超声脉冲传输到脑部中以产生将脑部中的目标组织液化的空化。引流导管被构造为检测超声脉冲。系统可以基于由引流导管测量的超声脉冲来执行像差校正算法,以自动地校正由穿过患者的头盖骨的超声脉冲引起的像差效应。
Description
相关申请的交叉引用
本申请主张2015年6月24日提交的题为“用于治疗脑内出血的组织摧毁术治疗系统和方法(HISTOTRIPSY THERAPY SYSTEMS AND METHODS FOR THE TREATMENT OFINTRACEREBRAL HEMORRHAGE)”的美国临时专利申请第62/184,179号的权益,其通过引用被全文并入。
参考引用
此说明书中提及的所有出版物和专利申请均以引用的方式并入本文,其程度如同每个单独的出版物或专利申请被明确和单独地指出通过引用并入。
技术领域
本公开总体上涉及用超声疗法产生的空化来治疗组织。更明确地,本公开涉及用超声疗法治疗脑部组织或脑部疾病,例如脑内出血(ICH)或脑肿瘤。
背景技术
组织摧毁术、或脉冲超声空化疗法是声能的极短、剧烈爆发诱发焦点体积内受控的空化(微气泡形成)。这些微气泡的有力扩张和瓦解使在焦点体积内的细胞和组织结构机械地均匀化。这相比于热消融的凝固性坏死特性是非常不同的最终结果。为在非热性的组织摧毁术领域内操作,需要以低占空比的高振幅声脉冲的形式传递声能。
与传统的聚焦超声技术相比,组织摧毁术具有重要优势:1)焦点处的破坏过程是机械的,而非热的;2)气泡云在超声成像上显示明亮,从而确认正确的治疗靶向和定位;3)经治疗的组织在超声成像上显示较暗(低回声),使得操作者知道哪些是经过治疗的;和4)组织摧毁术以受控且精确的方式制造损伤。重点强调的是,与微波、射频或高强度聚焦超声(HIFU)不同,组织摧毁术不是热模态。
脑部中血管的破裂会导致脑部内出血和凝血,术语被称为出血性中风或脑内出血(ICH)。ICH占据了所有中风的10-15%。当前的主流治疗仍然是开颅手术、一种高度侵入性的外科手术来去除凝块,伴随严重的脑神经功能的损伤。
已经研究了微创(MIS)立体定位方案,以用几天时间经由导管或溶血栓药物(tPA)来排出血肿。然而,tPA伴随有严重的并发症,并且ICH幸存者的功能结果仍未改善,这可能由于长时间的治疗使得神经损伤发展。
最近的临床前研究表明,使用磁共振引导的聚焦超声(MRgFUS)应用于头盖骨外,脑部中的凝块不用药物就能够被液化并用针吸出。然而,MRgFUS治疗时间仍不够短,从而避免神经损伤(40mL的凝块长达3小时)。由于需要的MRI时间长,所以花费高,并且不能治疗距离头盖骨2cm内的凝块。
超声路径上的头盖骨会引起经过头盖骨的超声信号的显著的衰减和散焦(像差作用)。为了校正像差,MRgFUS使用从患者脑部之前的三维CT扫描提取的头盖骨轮廓。然而,在MRgFUS治疗期间,不可能将患者放置在与前次扫描完全相同的位置,需要MRI来引导并监控穿过头盖骨的精确聚焦。该过程复杂且花费高。
此外,当前所有方法对大血肿(>40mL)都无效。显然对于更好ICH治疗的需要未满足,该ICH治疗能够微创且快速地减少脑部内的血肿而无需tPA,这将使得ICH患者恢复健康免受明显的神经损伤。
发明内容
组织摧毁术通过由高压超声短脉冲产生的密集活力气泡云制造组织分离。当使用短于2个周期的脉冲时,这些活力的气泡云的产生仅取决于负压力峰值(P-)超过诱发介质中的空化的固有阈值(在含水量高的软组织中典型地为26-30MPa)的位置。
提供一种将超声能量传输到患者的脑部的方法,包括以下步骤:将引流导管放置在患者的脑部中的目标组织内、将治疗换能器的多个换能器元件的焦点定位在目标组织内、将超声脉冲从多个换能器元件中的每个换能器元件传输到目标组织中、用定位在引流导管上或引流导管内的一个或多个压电传感器检测超声脉冲、以及用像差校正算法基于所检测的超声脉冲调整超声脉冲从多个换能器元件的传输以自动地校正由透过患者的头盖骨的超声脉冲造成的像差效应。
在一个实施例中,目标组织包括凝块或血肿。在另一实施例中,目标组织包括脑肿瘤。
在另一实施例中,该方法还包括用超声脉冲在目标组织上形成气泡云。
在一些实施例中,该方法还包括用超声脉冲液化目标组织。
在另一实施例中,该方法包括用引流导管从脑部排出液化的目标组织。
在一个实施例中,用像差校正算法基于所检测的超声脉冲调整超声脉冲从多个换能器元件的传输还包括,确定超声脉冲从治疗换能器的多个换能器元件中的每个换能器元件行进到一个或多个压电传感器的传播时间、计算多个换能器元件中的每个换能器元件与治疗换能器的参考元件之间的传播时间延迟、以及基于所计算的时间延迟调整超声脉冲从多个换能器元件的传输。
在一个实施例中,一个或多个压电传感器包括第一压电传感器和第二压电传感器。在该实施例中,用像差校正算法基于所检测的超声脉冲调整超声脉冲从多个换能器元件的传输还包括,确定超声脉冲从治疗换能器的多个换能器元件中的每个换能器元件行进到第一压电传感器和第二压电传感器的传播时间、使用第一压电传感器和第二压电传感器在从多个换能器元件中的每个换能器元件到第一压电换能器与第二压电换能器的中点的射线上的投影计算第一压电传感器和第二压电传感器之间的距离、计算超声脉冲从多个换能器元件中的每个换能器元件到第一压电传感器和第二压电传感器的中点的行进方向和行进时间、计算多个换能器元件的每个换能器元件的焦点与中点之间的相隔距离(stand-off distance)、以及基于第一压电传感器与第二压电传感器之间的距离、中点和相隔距离计算多个换能器元件的每个换能器元件的时间延迟。
在一个实施例中,该方法包括将一个或多个压电传感器放置在焦点内或邻近焦点。在另一实施例中,放置步骤还包括使引流导管前进通过治疗换能器的孔。
在另一实施例中,该方法包括电子地或机械地使焦点移位,以完全液化目标组织。
还提供一种配置成治疗患者的脑部中的目标组织的超声系统,包括脉冲发生器和放大器;超声治疗换能器,其联接到脉冲发生器和放大器并且具有配置为穿过患者的头盖骨想脑部的目标组织内的聚焦点传输超声脉冲以产生空化的多个换能器元件;引流导管,包括一个或多个压电传感器,该引流导管适于被放置在脑部内靠近聚焦点以测量超声脉冲;电子控制器,与脉冲发生器、放大器、超声治疗换能器、和引流导管的压电传感器联接,该电子控制器被配置为控制超声脉冲的传输并基于引流导管所检测的超声脉冲执行像差算法来调整超声脉冲从多个换能器元件中的每一个换能器元件的传输,以自动地校正经过患者的头盖骨的超声脉冲引起的像差效应。
在一个实施例中,超声治疗换能器被配置为传输组织摧毁术治疗脉冲,以产生空化从而液化患者的脑部内的目标组织。
在另一实施例中,引流导管包括引流端口,其被构造为排出患者的被液化的目标组织。
在一些实施例中,一个或多个压电传感器确切地包括一个压电传感器。在该实施例中,像差校正算法包括确定超声脉冲从治疗换能器的多个换能器元件中的每个换能器元件行进到压电传感器的传播时间、计算多个换能器元件中的每个换能器元件与治疗换能器的参考元件之间的传播时间的时间延迟、以及基于计算的时间延迟调整超声脉冲从多个换能器元件的传输。
在一些实施例中,一个或多个压电传感器包括第一压电传感器和第二压电传感器。在该实施例中,像差校正算法包括确定超声脉冲从治疗换能器的多个换能器元件中每个换能器元件行进到第一压电传感器和第二压电传感器的传播时间、使用第一压电传感器和第二压电传感器在从多个换能器元件中的每个换能器元件到第一压电传感器和第二压电传感器的中点的射线上的投影来计算第一压电传感器与第二压电传感器之间的距离、计算超声脉冲从多个换能器元件中的每个换能器元件到第一压电传感器与第二压电传感器的中点的行进方向和行进时间、计算多个换能器传感器中每个换能器元件的焦点与中点之间的相隔距离、以及基于第一压电传感器与第二压电传感器之间的距离、中点和相隔距离计算多个换能器元件中的每个换能器元件的时间延迟。
在一个实施例中,治疗换能器包括孔,引流导管被构造为前进穿过该孔到患者的脑部中。
附图说明
在所附的权利要求书中具体阐述了本发明的新颖特征。通过参考以下详细描述来获得对本发明的特征和优点的更好的理解,其中阐述了利用本发明的原理的说明性实施例,在附图中:
图1示出了一种组织摧毁术治疗系统。
图2示出了具有微型压电传感器的引流导管和引导线的示意图。
图3示出了用于校正穿过头盖骨传播的超声脉冲的像差以实现穿过头盖骨的组织摧毁术疗法的聚焦的射线追踪算法。
图4-5示出了用组织摧毁术超声疗法来治疗脑组织的一个实施方案和方法。
具体实施方式
组织摧毁术是一种非侵入性的基于空化的治疗,其使用非常短的高压超声脉冲来产生密集的、高能的、产生损伤的气泡云。这种组织摧毁术治疗可以当靶向在液体-组织界面时产生受控的组织侵蚀,并且当其在大量组织中被靶向时可以产生划定好的组织分离。另外,已经显示组织摧毁术能够使用与常规冲击波碎石术(SWL)在机械性能方面不同的表面侵蚀来破碎模型肾结石。可以使用超声B型成像实时引导和监测组织摧毁术治疗,因为1)空化气泡云在B型成像中显示为时间上变化的高回声区,使得治疗可以精确地被靶向,并且2)靶向区域的回声随着组织分离程度的增加而降低,这可作为实时监测损伤产生(图像反馈)的一种方式。
一般而言,在组织摧毁术治疗中,施加具有一个或多个声周期的超声脉冲,并且气泡云的形成依赖于来自初始引发的稀疏分布的气泡(或一个气泡)的正激波阵面(有时超过100MPa,P+)的压力释放散射。这被称为“冲击散射机制”。这种机制取决于在换能器的焦点处以脉冲的初始负半周期开始的一个(或几个稀疏分布的)气泡。然后由于从这些稀疏地开始的高峰正激波阵面的压力释放向后散射而形成微气泡云。这些向后散射的高振幅稀疏波超过了固有的阈值,从而产生了局部密集的气泡云。每个接下来的声周期都会通过从朝向换能器生长的气泡云表面向后散射而诱发进一步的空化。结果,利用冲击散射机制观察到沿着与超声传播方向相反的声轴生长的细长密集气泡云。这种冲击散射过程使得气泡云的产生不仅取决于负峰压,还取决于声周期的数量和正冲击的幅度。如果没有这些由非线性传播产生的强烈的激波阵面,当高峰负半周期低于固有阈值时,不会产生密集的气泡云。
当施加小于2个周期的超声脉冲时,可以使冲击散射最小化,并且密集气泡云的产生取决于超过了介质的“固有阈值”(“固有阈值机制”)的所施加的超声脉冲的一个或两个负半周期。对于高含水量的软组织(如人体内的组织),该阈值可以在26-30MPa范围内。使用这种固有阈值机制,损伤的空间范围是明确的和更可预测的。在负峰压(P-)没有显着高于该阈值的情况下,可以产生与换能器的-6dB波束宽度的一半一样小的亚波长可再现损伤。
组织摧毁术能克服常规ICH治疗的缺点,以提供脑内血肿的微创的快速的减少,无需溶血栓药物,也不管血肿的大小如何。本文描述的系统和方法在高压下传输微秒长度的超声脉冲,以使用焦点区域内凝块中的预先存在的气体核来产生密集的微气泡的空化云。微气泡的迅速扩张和瓦解诱发对邻近细胞的高应变和应力以将细胞分离成液状的无细胞匀浆。
根据一些实施例,组织摧毁术可以用于治疗脑组织或脑部疾病,例如ICH或脑肿瘤。在一个实施方案中,可以使用组织摧毁术穿过患者的头盖骨使凝块或脑肿瘤液化,然后可以通过引流导管排出产生的液体,而不使用溶血栓药物或外用剂。例如,在30分钟内可使用组织摧毁术穿过人的头盖骨将40mL的体外凝块液化,这比MRgFUS快六倍。通过参数优化,与MRgFUS相比,治疗时间可以缩短一个数量级以上。这些优化的参数可以用于治疗大于40mL和在距头盖骨2cm内的位置的凝块。本文所述的系统和方法使得即使对于>40mL的凝块也能以微创方法快速除去凝块,并且不需要溶血栓药物和MRI,从而显著改善ICH和脑肿瘤治疗。
根据本文描述的使用组织摧毁术来治疗脑部的实施例,导管可以被放置在目标组织中,例如患者的脑部内的凝块或肿瘤中。一个或多个声学水诊器或PZT传感器可以集成于放置在导管内的引导线,其随后可以被插入到脑部内的目标组织中,以直接测量来自位于患者体外的组织摧毁术治疗换能器的超声信号。组织摧毁术治疗换能器的所有元件的脉冲传输的时机可以被重新调整,以通过利用在传感器处从组织摧毁术治疗换能器的每个元件接收的超声信号的时机来穿过头盖骨重新聚焦。本文描述的用于经颅组织摧毁术治疗的传感器和相关的像差校正算法是新颖的,并且可以提供成本低廉且简化的装置,以在没有CT或MRI的情况下引导和监测经颅组织摧毁术治疗。
图1示出了根据本文所述的方法和实施例的被配置为在组织中产生空化气泡或气泡云的组织摧毁术系统。组织摧毁术系统和发生器被配置为生成复杂的波形,以支持本文所述的超声脉冲序列。系统100的简化框图在图1中示出。系统的主要部件是:计算机/控制器102、USB到串行转换器104、FPGA(现场可编程门阵列)108、高压控制器和电源110、放大器112和治疗换能器114以及引流导管117。
对于发生器的所有控制可以使用可在计算机/控制器102(例如,标准PC、膝上型计算机、平板电脑或其他电子计算系统)上运行的“组织摧毁术服务工具(HistotripsyService Tool)”软件来建立,并且经由诸如无线、USB或串行通信104的连接器与发生器通信。控制器102可以包括被配置为存储能够由控制器执行的一组指令的非暂时性计算机可读存储介质。
系统100可以被配置成接收多组不同的驱动参数并将它们循环,这使得用户能够创建宽范围的定制序列,其中所有参数(脉冲重复频率(PRF)、电压幅度、周期的次数、每组脉冲数、频率、启用的换能器元件通道、以及时间延迟)可以针对每个生成的脉冲设定为不同的值。脉冲之间的时间延迟可由PRF指定参数组或通过逐个脉冲手动/单独地指定它们。
对于整体电压幅度调节,高电压电平可以通过HV控制器110相应地改变。该方法不能用于两个脉冲之间的动态电压幅度变化,因为HV线上的所有电容器将花费太长时间放电。对于脉冲之间的动态电压幅度变化,可以在FPGA 108处使用PWM(脉宽调制),其中电容器充电脉冲的占空比可以被调制以产生期望的脉冲电压和合成的压力幅度。
USB到串行转换器
USB到串行转换器104可以将USB组合转换为串行,以便从PC或电子控制器到FPGA进行通信。应该理解的是,在发生器和控制器之间的连接不是USB连接的实施例中,可以使用其它转换器(或根本不使用)。
FPGA
FPGA 108从PC或电子控制器102接收信息,并且可以产生为了驱动放大器112所需的复杂脉冲序列。FPGA可以在100MHz时钟上运行,因为关键是使脉冲的速度以至少10ns的增量定时。
高压控制器和电源
高压控制器和电源110确定需要提供给放大器电路的DC电压的电平,以便在放大器的输出处具有足够的电压幅度水平。
放大器
放大器112接收由FPGA产生的脉冲,并由高压控制器和电源供应高电压。它产生通过使治疗换能器的阻抗与放大器的阻抗适当地匹配的匹配网络部件被馈送到治疗换能器114的高电压幅度脉冲。可能需要使用大量电容器,这些电容器可以存储足够的能量以在高电压幅度脉冲的产生期间支持峰值电流需求。
治疗换能器
治疗换能器114可以是单元件换能器或多元件超声治疗换能器,其包括多个换能器元件并且被配置成生成并传递本文所述的超声治疗脉冲至组织或其他介质中。在一些实施例中,多元件超声治疗换能器可以产生两个或更多个频率的超声脉冲。治疗换能器的有源换能器元件可以是压电换能器元件。在一些实施例中,换能器元件可以以共同的几何焦点安装至声学透镜。
在其他实施例中,换能器元件可以包括相控阵列,该相控阵列利用移位参数进行优化,以最大化经颅组织摧毁术凝块液化的治疗速度和位置,而不使头盖骨过热。头盖骨过热是制约经颅超声治疗的治疗速度和位置的主要限制。建议的参数优化将确保快速脑组织治疗并最小化对头盖骨的加热。在一些实施例中,治疗换能器可以实现大于1mL/min的脑组织液化速率,其比被动溶栓作用快几个数量级。
治疗换能器可以被配置为以具有持续大约1-4μs的一个高负压相位的单个超声脉冲穿过头盖骨产生空化,其中脉冲的负峰压直接超过用于介质的空化的“固有阈值”(对于脑组织如凝块约27MPa)。治疗换能器的焦点可以被电动地移位到其他位置,以覆盖大的治疗体积,并且与其他治疗形式相比,治疗时间可以缩短超过一个数量级。在一些实施例中,焦点移位速率可以保持在1%占空比以下,以避免头盖骨过热。
根据本文所述的系统和方法,可以在没有实时成像的情况下执行组织摧毁术脑部治疗。CT扫描可能需要作为目标组织诊断的一部分,但是在治疗之前进行。使用事先的CT扫描和立体定位方法,可以将引流水诊器放置在凝块内,并且导管尖端相对于凝块位置的准确位置是已知的。然后可以使来自组织摧毁术治疗换能器的焦点移位来液化大部分的脑组织,留下组织的薄的边缘以避免对邻近的脑组织造成损伤。
引流导管
图2是系统的引流导管117的放大图,其可以包括护套部分118和引导线部分120。护套部分可以包括柔性材料并且可以包括一个或多个引流口119,以有利于通过导管移除体液或组织。引导线部分120可以被插入护套部分118中以将导管移位至组织中的目标区域。引流导管可以还包括沿引导线部分120设置的一个或多个压电(PZT)传感器122。图2的实施例示出了2个PZT传感器,但是应该理解,可以实现任何数量的PZT传感器。例如,一些实施例使用单个PZT传感器。导管的PZT传感器可以被配置为测量来自治疗换能器114的各个元件的超声脉冲波形,以提取由治疗换能器传输的波形之间的时间延迟。时间延迟随后可以由系统用于像差校正。
另外,PZT传感器也可以用于监测空化的发生和维持,空化是成功进行组织摧毁术治疗的标志,并且可以随着来自空化部位的增加的声发射而进行监测。因为由头盖骨引起的衰减因人而异,所以这种实时空化检测可以用于确定为各个患者启动空化所需的功率。
软件和硬件可以被配置为相继地自动控制来自治疗换能器的每个元件的脉冲传输,并且收集和存储来自PZT传感器的信号。通过一次传输来自一个元件的单个脉冲只需要几微秒的时间并且超声从该元件行进到水诊器需要大约100μs的时间,整个数据采集可以使用自动化封装在一秒钟内快速完成。
组织摧毁术服务工具和电子控制器
组织摧毁术服务工具是可以在任何PC或计算系统(例如,电子控制器)上运行并且可以用于控制系统的软件。组织摧毁术服务工具可以用治疗换能器启动/停止治疗,设置并读取高电压电平、治疗参数(PRF、周期数、占空比、通道启用和延迟等),以及设置和读取其他服务及维护相关的项目。组织摧毁术服务工具和电子控制器可配置为设置/读取工作参数,启动/停止治疗等。它可以使用内部闪存或其他电子存储介质来存储所有参数。组织摧毁术服务工具和电子控制器可以与FPGA 108进行生成复杂脉冲所需的所有驱动参数的通信。它们还可以使用串行通信或其他电子通信方式与高电压控制器和电源110进行通信,在高电压控制器和电源110处可以设置/读取驱动电压的适当电平。
组织摧毁术服务工具和电子控制器可以联接到治疗换能器和引流导管的PZT传感器,以在经颅组织摧毁术治疗期间使用来自引流导管的反馈。当超声脉冲穿过人的头盖骨传播时,像差效应导致超声脉冲的负峰压降低。在一些实验中,已显示头盖骨的像差效应将负峰压降低至脉冲的自由场条件的约20%或更少。
在一个实施例中,引流导管的PZT传感器可以测量来自治疗换能器的每个换能器元件的超声脉冲信号,并且组织摧毁术服务工具和电子控制可以使用这些测量并执行像差校正算法以调整对每个换能器元件的电脉冲的时机,以校正像差效应。然后软件和硬件可以相继地自动控制每个元件的脉冲传输,并收集和存储测量的信号。通过一次传输来自一个元件的单个脉冲只需要几微秒的时间并且超声从每个元件行进到PZT传感器的时间只需要100μs,整个数据采集可以使用所提出的自动化封装在一秒钟内完成。
基于射线追踪的像差校正算法被配置为处理来自PZT传感器的测量的信号,以实现治疗换能器穿过头盖骨的精确聚焦和电或机械焦点移位。在下面描述的具体实施例中,该系统可以包括两个或更多个PZT传感器。该算法包含三个步骤,如图3所示。步骤如下:1)使用导管(H1、H2)内的两个或更多个PZT传感器和治疗换能器的发射换能器元件(TN)的已知位置定义平面ΠN,射线的行进方向被限制在该平面上。假定H1和H2距离TN足够远,使得来自每个单独元件的发射的信号作为平面波有效地行进。超声从TN行进到H1和H2的传播时间(t1和t2)可以基于信号到达PZT传感器与其从换能器元件传输之间的时间间隔来计算。使用Δt=t1-t2,计算dN1和dN2之间的距离为dist(dN1-dN2)=ctissue*Δt,其中dN1和dN2是H1和H2在从TN到两个传感器中点Hmid的射线上的投影。然后可以计算出波从TN到Hmid的行进方向θi和行进时间。2)知道θi,可以定义与该波传播正交的平面Πorth,并且其中心在Hmid处。然后假定平面波传播,通过计算Πorth和fn之间的相隔距离dx并且插入等式T(fn)=tmid+dx/ctissue中,可以计算给定焦点位置fn的每个换能器元件的必要时间延迟。3)基于对于治疗体积内所有移位位置所计算的时间延迟,可以在软件中生成移位模式。该软件可以配置为控制移位参数和空化监测,并且可以包含像差校正算法,以自动收集和处理PZT传感器信号并产生调整后的移位模式。
在一个实施例中,基于时间延迟的像差校正算法被用于实现治疗换能器穿过头盖骨的精确聚焦以及电或机械的焦点移位。在下面直接描述的具体实施例中,可以使用单个PZT传感器。根据该实施例,算法包括确定超声脉冲从治疗换能器的多个换能器元件中的每一个行进到压电传感器的传播时间,计算多个换能器元件中的每一个与治疗换能器的参考元件之间的传播时间的时间延迟,并且基于所计算的时间延迟调整来自多个换能器元件的超声脉冲的传输。
超声经颅治疗的一个限制是对头盖骨过热。为了解决这个问题,除了参数优化之外还可以采用多种策略。某些元素被点燃的顺序可以是交替的以减少由个别元素引起的局部发热。通过使用冷水作为对于头盖骨的超声耦合介质,也可以减少热量。
图4-5示出了用组织摧毁术超声治疗来治疗脑组织的一个实施方案和方法。图4示出了邻近患者的头盖骨放置的治疗换能器114和部分位于患者的脑部内的引流导管117,使得导管的引流端口位于脑部的目标组织(如血凝块或脑肿瘤)内或在其附近。为了获得精确的聚焦和焦点移位,导管中的PZT传感器可以靠近换能器的几何焦点放置。在一个实施例中,治疗换能器114可以包括孔123,以便导管穿过换能器阵列插入。导管架可以拧入孔中,在导管上标记有刻度,这使得操作者能够基于插入位置、角度和距离知道导管尖端的准确位置。
首先,参考图5的步骤50以及图4,引流导管117可以插入穿过患者的头盖骨,并且放置在脑部内的目标组织内或在其附近。接下来,参考图5的步骤52以及图4,可以将治疗换能器114的焦点定位在目标组织上。治疗换能器本身可以声学联接到患者的颅骨。接下来,参照图5的步骤54,超声脉冲可以从治疗换能器传输到目标组织中。在图5的步骤56中,引流导管的PZT传感器可以检测或测量来自治疗换能器的超声脉冲。最后,在图5的步骤58中,系统的软件和电子控制器可以基于来自PZT传感器的测量结果用像差校正算法来调整超声脉冲的时机,以校正由头盖骨引起的像差效应。
超声脉冲可被配置成在脑部的目标组织内产生空化或气泡云以液化目标组织。在一些实施例中,液化的目标组织可以用导管排出。在进一步的实施例中,治疗换能器的焦点可以被电子地或机械地移位以完全液化目标组织。
本文包括的示例和说明通过说明而非限制的方式示出了可以实践的主题的具体实施例。如上所述,其他实施例可以利用并从中导出,使得可以在不脱离本公开的范围的情况下进行结构和逻辑上的替换和改变。本发明主题的这些实施例在本文中可以单独地或共同地指代术语“发明”,这仅仅是为了方便而并非意图将本申请的范围自愿地限制到任何单个的发明或发明构思,如果事实上多于一个被披露。因此,尽管本文已经说明和描述了具体的实施例,但是为了实现相同的目的而推导的任何布置都可以代替所示的具体实施例。本公开旨在覆盖各种实施例的任何和所有的修改或变化。上述实施例的组合以及本文中未具体描述的其他实施例在阅读以上描述时对于本领域技术人员而言将是显而易见。
Claims (21)
1.一种将超声能量传输到患者的脑部中的方法,包括以下步骤:
将引流导管放置在所述患者的脑部中的目标组织内;
将治疗换能器的多个换能器元件的焦点定位在所述目标组织内;
将超声脉冲从所述多个换能器元件中的每个换能器元件传输到所述目标组织中;
用定位在所述引流导管上或所述引流导管中的一个或多个压电传感器检测所述超声脉冲;和
用像差校正算法基于所检测的超声脉冲调整超声脉冲从所述多个换能器元件的传输,以自动地校正由透过所述患者的头盖骨的超声脉冲引起的像差效应。
2.如权利要求1所述的方法,其中所述目标组织包括凝块或血肿。
3.如权利要求1所述的方法,其中所述目标组织包括脑肿瘤。
4.如权利要求1所述的方法,还包括用所述超声脉冲在所述目标组织上形成气泡云。
5.如权利要求1所述的方法,还包括用所述超声脉冲液化所述目标组织。
6.如权利要求5所述的方法,还包括用所述引流导管从所述脑部排出液化的目标组织。
7.如权利要求1所述的方法,其中用所述像差校正算法基于所检测的超声脉冲调整超声脉冲从所述多个换能器元件的传输还包括:
确定所述超声脉冲从所述治疗换能器的多个换能器元件中的每个换能器元件行进到一个或多个压电传感器的传播时间;
计算所述多个换能器元件中的每个换能器元件与所述治疗换能器的参考元件之间的传播时间的时间延迟;和
基于所计算的时间延迟调整超声脉冲从所述多个换能器元件的传输。
8.如权利要求1所述的方法,其中所述一个或多个压电传感器包括第一压电传感器和第二压电传感器。
9.根据权利要求8所述的方法,其中用所述像差校正算法基于所检测的超声脉冲利调整超声脉冲从所述多个换能器元件的传输还包括:
确定超声脉冲从所述治疗换能器的多个换能器元件中的每个换能器元件行进到所述第一压电传感器和第二压电传感器的传播时间;
使用所述第一压电传感器和所述第二压电传感器在从所述多个换能器元件中的每个换能器元件到所述第一压电传感器与所述第二压电传感器的中点的射线上的投影,计算所述第一压电传感器与第二压电传感器之间的距离;
计算所述超声脉冲从所述多个换能器元件中的每个换能器元件到所述第一压电传感器和第二压电传感器的中点的的行进方向和行进时间;
计算所述多个换能器元件中的每个换能器元件的焦点与所述中点之间的相隔距离;和
基于所述第一压电传感器和第二压电传感器之间的距离、所述中点和所述相隔距离来计算所述多个换能器元件中的每个换能器元件的时间延迟。
10.如权利要求1所述的方法,还包括将所述一个或多个压电传感器放置在所述焦点内或与所述焦点相邻。
11.如权利要求1所述的方法,其中所述放置步骤还包括使所述引流导管前进通过所述治疗换能器的孔。
12.根据权利要求5所述的方法,还包括电子地移位所述焦点以完全液化所述目标组织。
13.如权利要求5所述的方法,还包括机械地移位所述焦点以完全液化所述目标组织。
14.一种配置成治疗患者的脑部中的目标组织的超声系统,包括:
脉冲发生器和放大器;
超声治疗换能器,其联接到所述脉冲发生器并且具有多个换能器元件,所述多个换能器元件被配置成将超声脉冲穿过患者的头盖骨朝向所述脑部中的所述目标组织内的聚焦点传输以产生空化;
引流导管,包括一个或多个压电传感器,所述引流导管适于被放置在所述脑部内所述聚焦点附近,以测量所述超声脉冲;
电子控制器,与所述脉冲发生器、所述超声治疗换能器、以及所述引流导管的压电传感器联接,所述电子控制器被配置为控制所述超声脉冲的传输并且基于由所述引流导管所检测的超声脉冲执行像差校正算法来调整超声脉冲从所述多个换能器元件中的每个换能器元件的发射,以自动地校正由透过所述患者的头盖骨的超声脉冲引起的像差效应。
15.如权利要求14所述的超声系统,其中所述超声治疗换能器被配置成传输组织摧毁术治疗脉冲,以产生空化从而液化所述患者的脑部内的目标组织。
16.如权利要求15所述的超声系统,所述引流导管包括构造成排出所述患者的液化的目标组织的引流端口。
17.如权利要求14所述的超声系统,其中所述一个或多个压电传感器确切地包括一个压电传感器。
18.如权利要求17所述的超声系统,其中所述像差校正算法包括:
确定所述超声脉冲从所述治疗换能器的多个换能器元件中的每个换能器元件行进到压电传感器的传播时间;
计算所述多个换能器元件中的每个换能器元件与所述治疗换能器的参考元件之间的传播时间的时间延迟;和
基于所计算的时间延迟来调整超声脉冲从所述多个换能器元件的传输。
19.如权利要求14所述的超声系统,其中,所述一个或多个压电传感器包括第一压电传感器和第二压电传感器。
20.如权利要求19所述的超声系统,其中所述像差校正算法包括:
确定所述超声脉冲从所述治疗换能器的多个换能器元件中的每个换能器元件行进到所述第一压电传感器和第二压电传感器的传播时间;
使用所述第一压电传感器和所述第二压电传感器在从所述多个换能器元件中的每个换能器元件到所述第一压电传感器与所述第二压电传感器的中点的射线上的投影,来计算所述第一压电传感器与第二压电传感器之间的距离;
计算所述超声脉冲从所述多个换能器元件中的每个换能器元件到所述第一压电传感器与第二压电传感器的中点的行进方向和行进时间;
计算所述多个换能器元件中的每个换能器元件的焦点与所述中点之间的相隔距离;和
基于所述第一压电传感器和第二压电传感器之间的距离、所述中点和所述相隔距离来计算所述多个换能器元件中的每个换能器元件的时间延迟。
21.如权利要求14所述的超声系统,其中所述治疗换能器包括孔,所述引流导管被构造成前进穿过所述孔到所述患者的脑部中。
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CN108348772B (zh) | 2020-03-03 |
JP6979882B2 (ja) | 2021-12-15 |
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US11135454B2 (en) | 2021-10-05 |
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