CN1791440A - 具有增强的超声可见性的医疗器械 - Google Patents

具有增强的超声可见性的医疗器械 Download PDF

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CN1791440A
CN1791440A CNA2004800132306A CN200480013230A CN1791440A CN 1791440 A CN1791440 A CN 1791440A CN A2004800132306 A CNA2004800132306 A CN A2004800132306A CN 200480013230 A CN200480013230 A CN 200480013230A CN 1791440 A CN1791440 A CN 1791440A
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詹姆士·柯纳
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Abstract

本发明提供具有增强的超声可见性的医疗器械。本器械通过实时超声监控针尖在病人体内的位置实行局部给药、探针定位、液体排放、活组织检查或输送超声脉冲。本器械控制药物在实性组织内的扩散，将颗粒注入实性组织，并把药物输送到特定血管。随着针头插入，超声显像度与器官环境不同的液体注射到病人体内。该液体在被病人的组织减缓和停止前已移动较短距离，且该液流能被超声检测。在针头插入期间，用超声监控针头位置，直到针头处于理想作用点。然后通过针头输送治疗药物或插入探针，以进行诸如用射频加热消除肿瘤的治疗。在针头插入期间可调整流速，以保持针尖的适当设定图像。在作用点处，超声显像剂能重复并以不同流速搏动，直到液体分布图形令人满意，而后能输送药物。还可用安装在手持组件中的检测器，通过针头发送超声。

Description

具有增强的超声可见性的医疗器械
技术领域
本发明一般属于用定位超声导向的医疗器械。此类器械能用来例如探查、注入治疗剂、排出体液、进行活组织切片检查或提供诊断性成像剂。此类器械可用来增强治疗剂在实性组织内的扩散，以及将治疗剂输送到特定的血管中。此类器械可用于将探针在病人体内准确地定位，以便能够通过加热、冷冻或近距离放射来进行消除实性肿物的治疗。
背景技术
医学原理
准确、实时地了解针尖的位置是活组织切片检查的一项很显然的要求。为了把药物输送到特定的目标地点并避免对其它组织造成刺破损伤，医务人员也需要准确、实时地了解针尖的位置。
生物治疗预计在今后二十年中将占新研制药物的一半以上，它们通常都是较大的分子，能在血液中迅速分解，并且穿透细胞膜的能力有限。口服和静脉注射的技术还不够完善，而且一些生物治疗可能需要局部注射。
局部给药能够在作用部位使用更高浓度的治疗剂，同时使副作用最小，像细胞毒素化疗药物就属于这种情况。局部给药还可以减少所需要的剂量，从而降低成本，这就更有益于像基因治疗方面的应用。
肿瘤内注射，例如通过酒精注射消除肝肿瘤，需要精确的针头定位和输送药液。
通过加热，使用射频或微波(RF或MW)源、冷冻(冷冻手术)，或短程放射治疗，可实现使用探针的实性肿物切除。提高疗效的一项明显的要求就是将探针针头准确地定位。
抗血管生成疗法是指那些通过攻击给肿瘤提供养料的血管来破坏肿瘤的药物。其它方法还包括对这类血管进行栓塞或凝结。如果一种器械能够把药物或原料输送到特定的血管，就会增强这类治疗的疗效。
凝胶体疗法一般都有较高的粘性，并且用标准的注射器可能很难注射到病人体内。通过机械化或电动化来启动注射器活塞，这将改善凝胶体药物输送的人类工程学。
超声成像
超声是用于诊断的体内成像的标准技术，而且这些图像通常都是以灰白色呈现在显示屏上。多普勒超声技术(彩色多普勒超声检查法，脉冲波多普勒超声，连续波CW多普勒以及能量多普勒超声检查法)通常用来测量或显像血流。超声信号从流动的血液细胞中反射，并返回到检测器，返回的声波因多普勒效应而频移。也可以给可运动物体指定颜色，这样它们在灰色背景下呈现彩色，如病人体内的器官。
多普勒超声检测红血球的移动，这些红血球是直径大约为7.5微米的生物凹面盘状血细胞，并构成血液的40％到45％。彩色多普勒超声最低可以检测到微米(1微米＝0.001毫米)和速度在每秒1至100厘米范围内的血球移动。
针头超声成像
除非超声波脉冲以近似90度角来接近针头，否则平滑、细小的针头在超声输出成像中很难被觉察到。主要的活组织切片检查针头通常是14到18号的规格，而药物注射针头的规格从18号到26号不等或更高。
用来增强针尖超声显像的发明已获得专利。其中的一种方法是让针尖变粗或使针头坡口，但这有可能会增大针头插入时的创伤。
其它增强超声显像的方法包括：在针尖上制造气泡以更好地反射超声，在针尖安装微型检测器，振动空心活组织检查针头中携带的同轴固体探针，用注射器上的螺线管纵向摆动探针，以及用检测器使连接到针尖的流体柱产生纵向振荡。在这些方法中，有些方法碰到的困难是未能将摆动只限制在针尖，并且多普勒超声使整个针头都有颜色。有一项发明是把喇叭与空探针连接起来，无论多普勒光束入射的角度如何，都可以成功地把针尖展示成彩色的信号，但在插入过程中活体组织会阻挡针头，使针尖的彩色信号消失。
注射器和注射泵
用标准的注射器和人的大拇指的力量，以足够的速度和持续时间把液体注射到病人体内，该液体就能够被超声检测到。可是，为了用超声给针尖准确定位，用手动来均匀控制液体流动则很困难。
商业上已经有双管注射泵可供医务人员使用，而且可以用来混合环氧。这些器械不属于用来增强针头超声显像的器械。
由微机控制、自动化的注射泵是已经成熟的技术。它们可以用来及时控制给病人静脉注射的药量。一些泵包含封闭检测装置。这些泵的设计在针头插入过程中不能发出液体脉冲波，从而增强针头的超声显像。制造厂商包括生产实验室应用器械的费希尔(Fisher)科技公司、生产胰岛素泵的安尼玛斯(Animas)公司以及生产静脉注射泵的巴克斯特(Baxter)。
医疗器械的液压监控
美国专利6,251,079中公开了由Gambale等发明的利用压力准确找到输送管末梢位置的“经胸腔药物输送器械”。然而，该发明包括与药物输送管平行安装的压力检测管，以输送经胸腔药物，特别是注入到心肌层的治疗药物。
组织的液体调节
无针注射器械利用压缩气体迫使液体穿过皮肤，其速度最高可达400米/秒。如果精确地控制流速和流量，在注入治疗剂之前，液体脉冲具有调节组织和增强药物分布的潜力。
微球体的超声破裂
声学活性药物输送系统包括充满气体的微球体，这些微球体在外部超声下破裂，以将治疗混合物释放到体内的特定区域。声学活性药物输送系统包括微球体，微气泡，充满药物的微海绵，诸如小囊、胶粒、脂质体之类的可注射的纳米颗粒和其它带颗粒的药物，这些颗粒允许治疗剂的声学活化。
福冈大学医学院的立花(Tachibana)等在“运用超声输送药物”[超声波心动描记术-心血管超声和联合技术18(4)，323-328.doi：10.1046/j.1540-8175.2001.00323.x]中阐述了一种方法：“最近的研究显示，非热能超声能量可以用来瞄准或控制药物释放...[的]回声对比微气泡...用来把基因运送和释放到不同的组织和创口。”
微球体方法虽然是为静脉注射而设计，但如果通过针头来输送则可展示更强的功效，该针头配备装在注射器上的检测器，该检测器通过针头把切断的超声脉冲向下传送。
逆时声学治疗
使用与病人皮肤接触的检测器把治疗超声精确定位在目标点上，例如肿瘤，这被证实是非常困难的。正在开发中的逆时声学治疗包括：
·在肿瘤内放置超声源
·利用接触病人的外用阵列来发射超声并跟踪超声发射
·抽出内部超声
·根据要求从外部阵列使用治疗超声，利用得到跟踪的发射图形来准确地把超声定在目标点上。
发明内容
本发明提供了具有增强的超声显像的医疗器械。这种超声增强器械包括具有排放端的液体容器，被布置为与液体容器相连的液体排放装置，以便限定液体储存库，该排放装置用于将选定的压力施加到液体储存库中的液体，以通过该排放端将所述液体从该储存库中排出，具有入口端和出口端并限定其间的第一通道的第一导管，该入口端被置于该液体容器的排放端，该第一通道与该储存库连通；具有接头端和末梢尖端的针头并限定其间的针头通道的针头，该接头端被置于该第一导管的出口端，该针头通道与该第一通道连通；被可操作地连接到该液体排放装置上的液体供应装置，用于可选择地将选定的压力施加给液体，由此该选压的压力通过该液体容器的排放端排出液体，并通过该第一通道和该针头通道行进第一流程，用于在末梢尖端以为超声检测选定的液体流速排放。该液体可以是超声显影剂，如单独的盐水或与另一种治疗剂混合的液体。
本医疗器械可以被全部或部分地装入手持组件内。该液体容器可以是注射器的形式，液体排放装置可以用于注射器的活塞的形式。
随着针头被插入到病人体内深处，超声成像系统可能不再能够检测和显示该针头。本发明使得液体在针头插入时可以被注射到病人体内。该液体在被病人组织放慢和阻止前将移动一段较短距离，并且该速度和移动距离将足以被超声成像系统检测到。该液流或脉冲将在实时超声引导下突出针尖的位置。
该针尖的位置在插入过程中就可以被监控，直到所述针尖被定位在理想的作用点，例如特定的器官或癌症肿瘤。在某些实施例中，适配器可释放地将针头连接到该装置。一旦定位在理想的作用点，针头可以被拆离，并换上另一个针头或探针，或者可选地，探针可以被提供在该针头通道内。各种不同的探针可以被用来实施多种治疗。
该医疗器械也可包括端口接头；具有第二入口端和第二出口端并设定其间的第二通道的第二导管，该第二出口端被置于该端口接头处；被置于该第二入口端的第二接头，用于将该第二入口连接到选定的医疗组件，其中该端口接头被置于该第一导管的选定部分或阀门元件处，用于允许该第二通道与该第一通道之间的连通。多种医疗组件可被选择，包括以第二注射器形式的第二液体容器和以用于该第二注射器的第二活塞形式的第二液体排放装置。该第二活塞可被用于输送治疗剂。可选地，该医疗组件可以是用于活组织切片检查的真空源。
在理想的作用点处，该装置的不同实施例可被用于：
·输送第二液体，例如治疗药物
·输送多种液体，例如在体内相互混合的两部分治疗剂
·为活组织切片检查进行抽吸组织或用真空泵排放体内液体
·用一个或多个探针消除肿瘤
·放置柔软的液体导管以允许重复给药、局部输送药物
·控制治疗剂在实性组织内的输送
·注入微粒，例如在实性组织内注入药物洗提或放射性同位素示标微粒
·在特定的血管内输入治疗剂
·用通过针头传输的超声脉冲来加强治疗剂的扩散
·用通过针头传输的超声脉冲在体内分裂药物洗提微球体
·将超声源定位在理想的作用点，例如肿瘤，以允许进行逆时声学治疗。
在针头插入期间，突出显示针尖位置的超声显影剂可以被连续或间断地抽出。在本发明的机械化装置中，可通过手动控制来实现这一目标。在机电装置中，可利用手动控制或使用处理器的编程的脉冲来实现这一目标。
针尖位置可以通过超声显示器被监控，并且液体流速可以被调整。这样可以通过超声来改变可检测的空间，从而保持针尖位置的设定的图像。
本发明还结合超声系统和使用这类超声增强器械的方法。
在此需要注意，本发明所指的“器械”可理解为包括“仪器”或“装置”，它们可以通过适当改装后融入到系统中。
在此还需要注意的是，本发明的器械可以用作多种用途，包括医疗诊断、治疗、外科手术等，而且还可以在适当调整后以同样的方式用于兽医方面。
前面所述总结了本发明的主要特点以及一些选择性方面。通过优选实施例的描述、连同下面的附图，可以进一步理解本发明。
附图说明
附图阐述了本发明的目前优选实施例，并与随后的描述一起，用来解释本发明的原理。
图1示出本发明用来输送药物的机电装置。
图2示出本发明用来进行活组织切片检查的机电装置。
图3示出装有治疗剂(未示出)的手持组件的侧视图，以及装在带活塞注射器中的超声显影剂。
图3A示出液流和装置内手持组件的机械驱动的俯视图，注射器中装有治疗剂和超声显影剂。
图4示出手持组件的转换机构和机械驱动部分的立体图，该组件用来输送药物。
图5A和5B示出使用机械装置来传输液体的本发明实施例的俯视和侧视图。
图6示出包括连接到常规静脉注射泵的手持适配器的本发明实施例。
图7示出本发明实施例中与手持组件相结合的超声源，目的是让超声波通过针头输送到病人体内。
图8示出本发明实施例中三种液体的容器：超声显影剂和两种治疗剂。
图9A和9B示出把肿瘤消除探针与注射泵结合在一起的本发明实施例。
具体实施方式
现在将详细描述附图中所示的本发明的各种适合的实施例。应该注意，此说明是示例性的，旨在帮助理解本发明及操作原理。
本发明的器械包括从针头提供超声显影剂的装置及其分析，以增强针尖的超声显像。该器械可以由手持组件或具有手持组件的系统组成，系统中的手持组件与其它部件相连接，如液体容器，电源和仪表。
针头一词包括任何空心、微薄的器具，该器具可以用来刺破、插入或探查组织、器官、体腔等。针头可以用来把物质放进病人体内或从体内取出，或进行其它治疗或诊断功能。针头一词意在包括棒杆或金属丝一类的医疗器具、套管、探针、管子和腔体、管心针及诸如此类的东西。病患可以是任何适合的动物，包括人类。
液体是指任何适合的流体、悬浮液或气体。
液体供应装置可以是注射泵、可变速液体输送泵、蠕动泵或其它抽吸液体的装置。
液体供应装置可以通过机械方法驱动，如压缩或扩展弹簧或其它机械方法，或者通过电子机械方法驱动，如电动机，螺线管驱动器或其它电子机械方法，或者通过气压或液压方法来驱动。
如图1，2，3，3A和4所示，电子机械装置包含手持组件、针头、针头适配器、装有两种不同液体的注射器、液体导管、液体泵、控制器、压力传感器、流量传感器、液体转换机构、阀门、步进电动机、传动轴和联动装置。
图1示出了用于在病人体内深处进行局部药物输送的装置
超声检测器(1)发射和接收脉冲波，以便在超声显示器(3)上示出病人(2)体内的图像。手持组件(5)用来把针头(6)插入到病人体内，到达理想的作用点(4)，即器官、肿瘤等等。液体以足够的速度从针头末梢尖端(7)射出足够的移动距离，以使超声能够监测到。
超声能够检测到范围较广的液体速度和移动距离：速度从1厘米/秒到100米/秒，距离从10微米到2厘米。超声也可以检测到更大的范围。
超声设备可以用来使血流成像，在此操作过程中经常使用声谱仪。因此，把超声显影剂的流速设在30至300厘米/秒之间会比较有利，这样与人类血管中常见的血流速度相一致。
使用标准或多普勒超声可以实时监控针头的位置。如果选用多普勒超声，病人的体内器官可以呈灰色显示出来，而从针尖射出的液体则有一种独特的颜色。
手持组件(5)的末梢端装有流量计传感器(8)，该传感器与流量计(9)连接在一起。手持组件(5)的末梢端装有压力传感器(10)，该传感器与压力计(11)连接在一起。启动控制器(12)和(13)可用来开启/关闭液流和调整流速。
在针头插入期间，如果液体流速太高，它会破坏组织，而且液体的分布会难以预料。液体可能朝多个方向流动几厘米，超声检测的空间范围太大，难以精确监控针尖。因此，这里需要实时调整流速，以便把流动液体的区域控制在接近针尖的小范围内。
检测器用来感知注射器活塞的位置和速度，并与控制器连接，它也可以用来感知液体流速。
控制器(14)是微处理器，通过电缆线(27)与手动控制器、电源和驱动器(15)、流量计(9)、压力计(11)、输入/输出(17)、流量计/泵压力显示器(18)相连接。控制器输入/输出(17)可以输入命令来指定脉冲化的流程等。
电源和驱动器(15)驱动注射泵电动机(16)，该电动机与传动轴(未示出)连接，传动轴用来启动装有超声显影剂(19)的注射器活塞(20)。一旦针尖(7)定位在理想的作用点(4)，可以中止1号液体的流动，2号液体，即治疗剂(未示出注射器)被注入病人(2)体内。
为了能够精密、实时地调整流速和控制治疗剂的输入量，操作人员可以设定电动机的每分钟转数范围、电动机连接轴、传动轴和注射器活塞启动链杆之间的传动比、发动机驱动卡和自动控制器。
液流通过手动转换机构(23)来开启，该装置与按钮(22)连接。转换机构(23)同时啮合/脱离注射器活塞驱动器，从一个注射器转换到另一个注射器，并把液体阀(21)从一个注射器转换到另一个注射器。
在针管插入期间，有几种方法使被射出的1号液体，即超声显影剂，突出针尖的位置。其中的关键要求是1号液体相对无生物危害(如消毒盐水)，而且从超声显像来说，该液体与周围的组织环境形成对比。该液体的超声显像可能比组织环境更多或更少。
由于在注射两种液体之间，不会冲洗针头和液体导管，因此，1号液体相对于2号液体的负面影响必须最小。1号液体可能含有增加治疗剂功效的药物，如防止感染或帮助或阻止治疗剂移动的药物。它还可能含有化学添加剂，用来减少其粘性。1号液体可以是病人自己的血液，可以作为输入液、超声显像气体或消毒水再次使用。
可选地，把二氧化碳气体作为适合的超声显像流体，该气体分散在体内，而且其超声显像效果很明显。它能够通过装满液体的针头来输送，并以小气泡的形式注入到病人体内。
输送到作用点的2号液体，即治疗剂，可以是：液体药物、悬浮在液体内的固体药物颗粒、悬浮在液体内的药物洗提微球体、或其它可以通过针头用压力输送的治疗剂。这样可以输送少量的治疗剂，0.2至1.0毫升。
本器械可以用来控制所输送药物的扩散图形。针尖一旦被定位在作用点，超声显影剂就可以搏动，如果必要，可以重复并以多种流速来搏动，而且液体扩散图形可以得到监控。这些初步液体脉冲的流速很高，足以调节位于作用点的组织，从而有利于药物的扩散。一旦扩散图形令人满意，随后就可以输送2号液体即治疗剂。
本器械可以用来把悬浮微粒搏动到实性组织中，目的是把微粒射入组织中，并且可以进行长期的局部治疗。这些微粒可以是药物洗提、装满药物的微球体、能生物分解的微粒、放射性同位素示标玻璃料、放射性同位素示标金属、陶瓷、塑料或其他悬浮固体治疗剂。
使用安装在手持组件中的液体压力计，本器械可以用来把治疗剂输送到特定的血管中。维持均衡流速所需要的压力将随着背压而改变，如果针尖刺破血管壁，该背压可能会下降，超声显影剂直接被注入到动脉或静脉中。因此，通过监控压力和压力变化的速度，可以将针头定位，把药物直接输送到特定的血管内。本系统中可以纳入听觉或视觉警报，在泵压已经下降和针头刺破血管壁时发出信号。
图2示出了用于在病人体内进行深度活组织切片检查的器械。
超声检测器(1)发送和接收脉冲，目的是在超声显示器(3)上显示病人(2)的体内图像。手持组件(5)用来把针头(6)插入病人体内，接近理想的作用点(4)、器官、肿瘤等。
液体从针头末梢尖端(7)以足够的速度和距离射出，以便能够被超声检测到。
装在手持组件末梢端(5)的流量计传感器(8)与流量计(9)连接在一起。装在手持组件末梢端(5)的压力传感器(10)与压力计(9)连接在一起。启动控制器(12)和(13)可以用来开启/关闭液流并调节流速。
控制器(14)是微处理器，通过电缆线(27)与手动控制器、电源和驱动器(15)、流量计(9)、压力计(11)、输入/输出(17)、真空源(33)、阀门(32)和流量计/泵压/真空显示器(18)连接。控制器输入/输出(17)可以输入指令，用来指定脉冲流动等。真空源(33)用真空线(34)与手持组件(5)连接。
电源和驱动器(15)驱动注射泵电动机(16)，该电动机与驱动轴连接(未示出)。驱动轴驱动活塞致动器(29)，该致动器沿支持杆(31)滑动，以启动装有超声显影剂(19)注射器的活塞。
针尖(7)一旦被定位在理想的作用点(4)，就可以停止液流并关闭阀门(32)。真空源(33)随后被用来吸出活组织进行切片检查。
针头还可以与探针一起使用来进行活组织切片检查。
图3示出用来输送药物的手持组件。
如图所示，用来支撑针头(6)的手持组件(5)配有针头适配器(26)，用来把药物注射到病人体内。传感器(8)检测液体的流速。压力传感器(10)检测液体的压力。顶端的启动控制器(12)带有定位传感器(24)，用来设置流速，而下端的启动控制器(13)和开关(25)用来开启和关闭液流。流量传感器(8)、压力传感器(10)、顶端启动定位传感器(24)和下端启动开关(25)通过电缆线(27)连接，该电缆线一直延伸到流量计、压力计和控制器。
电源和驱动卡(未示出)通过导线(28)连接到注射泵电动机(16)，该电动机用机械方法与驱动轴(未示出)连接(39)。另一项替代方法是用电池来驱动泵电动机(未示出)。驱动轴与活塞致动器(29)相连接，该致动器沿转换机构(23)的水平支撑杆滑动，以带动装有超声显影剂(19)的注射器活塞(20)。该注射器(19)通过可调节的注射器夹(30)固定在转换机构(23)上。
在将针头(6)插入到病人体内期间，启动活塞(20)，1号液体从注射器流出，通过液体阀门(21)、液体导管(42)和针头(6)，并通过针头注入到病人体内。
一旦针尖被定位在理想的作用点，1号液体即超声显影剂的流动就被中止，以便让2号液体即治疗剂流动(注射器未示出)。通过启动与转换机构(23)相连接的按钮(22)，液体流动即开启。转换机构(23)同时啮合/脱离注射器活塞致动器，从一个注射器转换到另一个注射器，并把液体阀门(21)从一个注射器转换到另一个注射器。
图3A示出了液流和用来输送药物的手持组件的机械驱动部分的俯视图。
注射泵电动机(16)机械地连接(39)到驱动轴(37)，该驱动轴由两个轴承(38)支撑。驱动轴机械地连接(40)到任何一个注射器活塞致动器(29)上，该致动器沿转换装置(未示出)的水平支撑杆平行于驱动轴滑动。活塞致动器(29)驱动1号液体注射器(19)的活塞(20)或2号液体注射器(35)的活塞(36)。注射器通过转换机构(未示出)与驱动轴成垂直方向移动，目的是把任何一个机械连接器(40)啮合到驱动轴上。注射器(19)和(35)通过一对可调节的注射器夹(30)固定在转换机构上(未示出)。
从任何一个注射器流出的液体通过柔软的液体导管(42)流向阀门(21)，并通过针头适配器(26)流入针头(6)。压力传感器(10)和流量传感器(未示出)监控手持组件末梢端(机架未示出)的液流。
一旦针尖被定位在理想的作用点，1号液体即超声显影剂(19)的流动就被中止，以便让2号液体即治疗剂(35)流动。通过启动与转换机构(未示出)连接的按钮(22)，液体流动即开启。转换机构(未示出)使注射器与驱动轴成垂直方向移动，同时啮合/脱离注射器活塞致动器(29)的连接器(40)，并通过阀门致动器(41)使液体流过阀门(21)。
图4示出了转换机构和用来发送药物的手持组件的机械驱动部分的立体图。
注射泵电动机(16)机械地连接(39)到驱动轴(37)，该驱动轴由两个轴承(38)支撑。驱动轴机械地连接(40)到注射器活塞致动器(29)，该致动器沿转换机构(23)的水平支撑杆平行于驱动轴滑动，以此启动注射器活塞(未示出)。注射器(未示出)通过可调节的注射器夹(30)固定在转换机构(23)上。图4只示出了两套活塞致动器(29)、连接器(40)和注射器夹(30)中的一套。
通过启动与转换机构(23)连接的按钮(22)，液体流动即开启。转换机构(23)按照与驱动轴成垂直的方向来移动注射器，用来啮合/脱离注射活塞致动器(29)与驱动轴(37)之间的连接器(40)。转换机构(23)通过带有阀门致动器(41)的阀门(未示出)同时开启液体流动。
图5A和5B示出了用机械机构驱动液体传送的本发明实施例的俯视和侧视图。
图中示出了具有针头适配器(26)的手持组件(5)，用来支撑针头(6)，把药物注射到病人体内深处。可以用压力传感器(10)来检测液压。顶部启动控制器(12)与机构(43)相连接(未示出)，该机构搏动来自于1号液体注射器(19)中的液体。下端启动器(13)与相同的机构(43)相连接，用来搏动来自于2号液体注射器(35)中的液体。
上述机构(43)包括用来夹住注射器活塞(20)和(36)的注射器活塞致动器(29)，用来调节弹簧(44)预负荷压力的驱动弹簧(44)和控制钮(45)。这种调节将改变每个脉冲的液体流量。注射器(19)和(35)通过一对可调整的注射器夹(30)固定在装置(5)上。
液体通过导管(42)从任何一个注射器中流出，并通过针头适配器(26)流向针头(6)。
图6示出了包括连接到常规静脉注射泵的手持适配器的本发明的实施例。
图中示出具有针头适配器(26)的手持组件(5)，用来支撑针头(6)，把药物注射到病人体内深处。压力传感器(10)检测液压。用启动控制器(12)和开关(24)来开启和关闭液流。用流动调节按钮(48)和传感器(未示出)来改变流速。压力传感器(10)、流动调节传感器和启动开关(25)通过电缆线(27)连接到电端口(47)，例如常规注射泵(46)上的RS232端口。
通用注射泵(46)，如巴克斯特(Baxter)AS50，通过柔软的液体导管(42)把液体从1号液体注射器(19)驱动到手持组件(5)。
当针头(6)定位在病人体内理想的作用点时，液体就从2号液体注射器(35)中流出来。2号液体注射器(35)可以安装到手持组件(5)上，或如图6所示，2号液体注射器(35)可以单独放置和手动启动。2号液体注射器针头(49)通过手持组件上的一个端口(50)，然后液体从注射器(35)中排出，并通过手持组件针头(6)进入病人体内。
图7示出了本发明的实施例，其中把超声源结合在手持组件内，目的是让超声脉冲波通过针头输送给病人。
与通过在病人皮肤上放置检测器来发送超声相比，该装置可以使发送给病人的超声脉冲波更易控制和均匀，不受针头插入深度、组织密度和其它变量的影响。这种超声脉冲的效用为：
·激活治疗剂的药理活动，例如通过组织和穿过细胞膜来加强药物传送，和/或
·用超声脉冲波来调节病人的组织，以便改善治疗剂的分布和功效，和/或
·创造高温条件，能够加强毁灭病变组织，如癌组织，和/或
·在用药后用本装置立即分裂药物洗提微球体。
图中示出了具有针头适配器(26)的手持组件(未示出)，用来支撑针头(6)，把药物注入病人体内深处。可以从1号液体注射器(19)或2号液体注射器(35)使液体脉冲化。
液体从任何一个注射器通过导管(42)和针头适配器(26)流进针头(6)。
检测器探针(51)或多检测器组(未示出)与液体导管(42)相连接，并产生超声能量，该能量通过针头(6)转移到病人体内。检测器或检测器组与控制器和电源(没有描述出来)连接。控制器能够用来调节频率、持续时间、模式、功率和其它超声脉冲参数，可以或不与显示器连接。
可选地，检测器探针(51)或多检测器组(未示出)可以安装在标准手动注射器(未示出)上，并与液体接触，以此产生超声能量，该能量通过针头转移到病人体内。
图8示出了装有三种液体的容器的本发明实施例：超声显影剂(19)和两种治疗剂(35)和(52)。注射泵致动器可以通过针头适配器(26)把液体从任何单独的容器或同时从两个或三个容器供应到针头(6)。
这种装置的用途是输送含有两种溶液的治疗剂，为了使治疗剂发挥功效，在给药前，这两种溶液必须立即混和，或在某些情况下必须在病人体内混和。
还可以使用两种不同的装置通过探针来消除肿瘤。一旦针头精确定位，手持组件可以从针头中脱离，通过针头插入一个或多个探针。然后可以用探针消除肿瘤，消除方法包括通过热量、射频(RF)或微波(WM)能量、冷冻破坏或使用尖端带有放射源的棒杆进行近距放射疗法。
图9A和9B所描述的发明实施例，已经把肿瘤消除探针合并在手持组件内。在这种装置中，针头不需要脱离手持组件，而且不必通过针头插入单独的肿瘤探针就能把肿瘤消除。
图9A示出了在实时超声导向下用来给针头定位的本发明实施例。
超声波检测器(1)传送和接收脉冲，以便在超声显示器(3)上显示病人(2)体内的图像。手持组件(5)用来把针头(6)插在病人体内理想的作用点(4)，如实性肿瘤。
1号液体，即超声显影剂(19)，从针尖(7)以足够的速度和移动距离推出，以便让超声能够检测到。
针头(6)内的射频探针(53)通过封闭的针头适配器(26)连接到射频控制器(54)和电源(15)上。
启动控制器(12)和(13)可用来调节1号液体即超声显影剂(19)的流量和射频功率。
图9B示出了本发明中放置探针来消除实性肿瘤的装置。
一旦针头(6)被定位在理想的作用点(4)，用滑动装置(55)把探针(53)放在病人的组织内。启动控制器(13)调节射频功率，以便消除实性肿瘤。
在肿瘤消除后，可以把探针(53)退回到针头(6)里来撤出装置。
另一种替代方法是重复给药，实现局部药物输送。一旦针头准确地定位，手持组件可以与针头脱离，使用推杆把柔软、已消毒的液体导管通过针头插入。一旦液体导管定位在理想位置，针头和推杆就可以退出。然后通过导管来重复输送药物剂量，该导管可以是PortaCathTM，Hickman导管、PICC或其他类型的输送药物的柔软导管。
本器械的各实施例可以与以下器械配套：
·通过诸如螺纹适配器防漏适配器的各种针头
·各种针尖几何形状，包括标准开口、角状开口、或针尖侧面带槽的闭口、或几何形状的组合
·多腔针头
·与多腔结合在一起的管心针，用来做活组织切片检查或排泄液体；探针防止组织进入到用来抽吸组织的腔内，而用来排放超声显影剂的腔则保持敞开
·多种液体容器，这些容器可以用可调节的夹子来固定，并使用防漏配件与柔软的液体导管连接
·注射物接入部件的可移动盖，这样在为每位病人更换部件时使操作更容易
·透明的盖和/或开口，以便能够从视觉上监控液体容器和/或导管。
结论
本发明公开的器械用来进行局部注射药物、将探针定位、排泄体内液体、进行活组织切片检查、或根据病人体内针头位置的实时超声图像来施加脉冲。本器械可以控制药物在实性组织内的扩散并把药物输送到特定的血管。
本器械包括：手持组件或带有针头的系统、针头适配器、液体容器和抽吸液体的装置。它可包括流量控制器、压力传感器、流量传感器、液体转换机构和阀门。手持组件可被连接到压力计、流量计、控制器、控制器I/O、显示器和电源上。
在针头插入时，第一液体，即与器官环境形成对比的超声显影剂，被注射到病人体内。该液体在被病人的组织放慢和停止之前已经移动了较短的距离。该速度和移动距离足以使超声能够检测到。
在针头插入期间，针尖位置得到监控，直至所述针尖定位在理想的作用点上，例如特定的器官或癌症肿瘤。
第二液体或几种液体，如治疗药物，然后被输送。可选地，可以用真空泵来抽吸组织，用于活组织切片检查或排出液体。
可选地，可通过针头插入探针，以便通过加热、冷冻、短距离放射治疗或其他方法来消除实性肿瘤。
在针头插入期间，第一液体可以通过用手动控制器连续或间断地抽吸、或使用处理器进行搏动。针尖位置通过超声显示器来监控，液体流速可以调整。这将改变能被超声检测到的空间，以便保持合适的针尖的确定图像。
用安装在手持组件上的检测器或检测器组，本器械可以用来把超声通过针头发送到病人体内。这样能够使药物微粒发生声学激活和其它用途。
本器械还能够用来控制输送药物的扩散图形。一旦针尖定位在作用点，超声显影剂就能够搏动，如果必要，可以重复和以多种流速发出脉冲，而且液体扩散得到监控。一旦这一步令人满意，第二液体，即治疗剂，随后就被输送。
本器械还能够用来把微粒注入到实性组织内。一旦针尖定位在作用点，可以调整流速，使之足以喷射悬浮液体并把微粒注入到实性组织内。
本器械可以显示设置流速、液体压力和压力变化的速度。
随着背压变化，维持通过针头的恒定液流所需要的压力也将改变。如果针尖刺破血管壁，背压就会下降，而且超声显影剂被直接注入到动脉或静脉中。因此，通过监控压力和压力变化速度，可以对针头进行定位，以将治疗剂直接发送到某个特定的血管里。
这些权利要求及在此使用的语言，需要根据已经描述过的本发明的变量来理解。不局限于这些变量，而应理解它们覆盖了本发明的全部内容，这在本发明以及在此公开的内容中没有明确说明。
前面所述是对具体装置的说明，展示了如何能够应用和使用本发明。这些装置只是示例性的。下面的权利要求进一步描述和限定本发明的更广泛和更具体的各个方面。

Claims (49)

1.一种超声增强型医疗器械，包括：
a.具有排放端的液体容器，
b.液体排放装置，被置于与该液体容器连接，以限定液体储存库，该排放装置用于将选定的压力施加到该液体储存库中的液体，以将所述液体通过该排放端从该储存库中排出，
c.第一导管，具有入口端和出口端、并在两者之间限定第一通道，该入口端被置于该液体容器的排放端，该第一通道与该储存库连通；
d.针头，具有接头端和末梢尖端、并在两者之间限定针头通道，该接头端被置于该第一导管的出口端，该针头通道与该第一通道连通；
e.液体供应装置，被可操作地连接到该液体排放装置，用于可选择地将该选定的压力施加到该液体，
其中该选定的压力通过该液体容器的排放端排出液体，并通过该第一通道和该针头通道行进第一流程，用于以为超声检测选定的液体流速在该末梢尖端排出。
2.如权利要求1所述的超声增强型器械，其中该液体包括超声显影剂。
3.如权利要求2所述的超声增强型器械，其中该超声显影剂是盐溶液。
4.如权利要求2所述的超声增强型器械，其中该液体包括治疗剂。
5.如权利要求1所述的超声增强型器械，其中该液体供应装置包括被可操作地连接到该液体排放装置的驱动装置，以及用于可选择地操作该驱动装置的致动器。
6.如权利要求5所述的超声增强型器械，其中该致动器可手动操作。
7.如权利要求5所述的超声增强型器械，进一步包括控制器，被电连接到该驱动装置和该致动器，用于可选择地施加该选定的压力，从而控制该液体流速。
8.如权利要求5所述的超声增强型器械，进一步包括检测器装置，用于感知被施加到该液体的选定的压力，并输出反映用于输入到该控制器的压力的电信号。
9.如权利要求1所述的超声增强型器械，其中该液体供应装置包括用于调节该末梢尖端处排出的液体流量的装置。
10.如权利要求1所述的超声增强型器械，其中该液体流速可实时调整。
11.如权利要求1至10中任何一项所述的超声增强型器械，其中该选定的压力是搏动的、连续的或间断的，以便该液体在该末梢尖端处以搏动的、连续的或间断的液流被排出。
12.如权利要求1至12中任何一项所述的超声增强型器械，其中该液体容器是注射器，并且该液体排放装置是被可滑动地置于该注射器内的活塞。
13.如权利要求1所述的超声增强型器械，进一步包括被置于该第一导管上的选定位置处的阀门元件，所述阀门元件具有封闭装置，用于可选择地减少或停止进入该第一通道或该第一通道内的液体吞吐量。
14.如权利要求13所述的超声增强型器械，其中该阀门元件被置于该第一导管的入口端。
15.如权利要求13所述的超声增强型器械，其中该阀门元件是单向阀门元件，用于允许该液体流入该第一通道，并阻止该液体以反方向流入该液体容器的排放端。
16.如权利要求1所述的超声增强型器械，进一步包括适配器，用于将该针头的接头端可释放地连接到该第一导管的出口端，该适配器限定适配器通道，用于保持该针头通道与该第一通道之间的连通。
17.如权利要求16所述的超声增强型器械，其中所述的适配器包括一装置，用于可释放地耦合至少一个具有接头端的第二针头和末梢尖端，并限定两者之间的第二针头通道。
18.如权利要求16所述的超声增强型器械，其中所述的适配器包括用于可释放地将探针耦合到该针头通道内的针头的装置，该适配器通道和该针头通道的尺寸允许该探针插入其中，所述探针延伸到所述末梢尖端之外。
19.如权利要求18所述的超声增强型器械，其中所述的探针包括治疗装置。
20.如权利要求19所述的超声增强型器械，其中该治疗装置包括用于施加至少射频、微波加热、冷冻或短距离放射治疗之一的装置。
21.如权利要求1所述的超声增强型器械，进一步包括：
a.端口接头；
b.第二导管，具有第二入口端和第二出口端、并在两者之间限定第二通道，该第二出口端被置于该端口接头上；
c.第二接头，被置于该第二入口端，用于将该第二入口连接到选定的医疗部件上，
其中该端口接头被置于该第一导管的选定部分或该阀门元件上，用于允许该第二通道和该第一通道之间的连通。
22.如权利要求21所述的超声增强型器械，其中该选定的医疗部件包括：
a.第二液体容器，具有第二排放端，
b.第二液体排放装置，被置于与该第二液体容器连接，以便限定第二液体储存库，该第二液体排放装置用于将第二选定压力施加到该第二液体储存库中的第二液体，以通过该第二排放端将所述第二液体从该第二储存库中排出，
c.第二液体供应装置，被可操作地连接到该第二液体排放装置，用于可选择地将该第二选定压力施加到该液体，
其中该第二选定压力通过该第二液体容器的第二排放端排出该第二液体，并通过第二通道行进第二流程，到达该阀门元件之一或该第一通道的选定部分，并通过该针头通道，以第二流速在该末梢尖端排出。
23.如权利要求22所述的超声增强型器械，其中该第二液体供应装置包括被可操作地连接到该第二液体排放装置的第二驱动装置，以及用于可选择地操作该第二驱动装置的第二致动器。
24.如权利要求23所述的超声增强型器械，其中该第二致动器可手动操作。
25.如权利要求23所述的超声增强型器械，其中该控制器被电连接到该第二驱动装置，用于可选择地施加第二选定压力，从而控制该第二流速。
26.如权利要求25所述的超声增强型器械，进一步包括第二检测器装置，用于感知被施加到该第二液体上的选定压力，并用于输出反映用于输入到该控制器的压力的电信号。
27.如权利要求22所述的超声增强型器械，其中该第二液体供应装置包括用于调节在该末梢尖端处排出的第二液体流量的装置。
28.如权利要求22所述的超声增强型器械，其中该第二液体的流速可实时调节。
29.如权利要求22至28中任何一项所述的超声增强型器械，其中该第二选定压力是搏动的、连续的或间断的，以便该第二液体在该末梢尖端处以搏动的、连续的或间断的液流被排出。
30.如权利要求22至29中任何一项所述的超声增强型器械，其中该第二液体容器是第二注射器，并且该第二液体排放装置是被可滑动地置于该第二注射器内的第二活塞。
31.如权利要求22所述的超声增强型器械，进一步包括转换元件，用于转换该第一液体供应装置和该第二液体供应装置的开启。
32.如权利要求22所述的超声增强型器械，其中的第二液体是治疗剂。
33.如权利要求32所述的超声增强型器械，其中该治疗剂包括一种或多种：
a.液体药物，
b.被悬浮在液体中的固体药物，
c.药物洗提微球体，或被悬浮在液体中的其它声学活性药物输送系统，
d.放射性同位素标签药物，
e.放射性同位素标签颗粒，
f.用于成像系统的成像系统对比剂，该成像系统包括CT扫描、核磁共振成像、超声或X光。
34.如权利要求21所述的超声增强型器械，其中该选定医疗部件包括真空源，用于在进行活组织检查时吸出组织。
35.如权利要求21所述的超声增强型器械，其中该选定医疗部件包括真空源，用于液体或物质排放。
36.如权利要求21所述的超声增强型器械，其中该选定医疗部件包括用于提供液体的导管。
37.如权利要求21所述的超声增强型器械，进一步包括(a)到(c)的多个部件，用于该第一通道与被连接到多个选定医疗部件的多个通道之间的连通。
38.如权利要求1至37中任何一项所述的超声增强型器械，进一步包括机架，所述机架支撑该液体容器、该适配器或该针头中的至少一个。
39.如权利要求38所述的超声增强型器械，其中该机架可手动操作。
40.如权利要求1所述的超声增强型器械，进一步包括被可操作地连接到该液体排放装置的输入泵，用于从远处给针头提供液体。
41.如权利要求40所述的超声增强型器械，进一步包括机架，所述机架支撑该第一导管、该适配器或该针头中的至少一个。
42.如权利要求38或39或41中任何一项所述的超声增强型器械，进一步包括超声检测器，或多检测器组，被支撑在该机架内，并与和该第一通道连通的该第一导管接触，该超声检测器或检测器组用于通过该针头通道传输超声脉冲或连续的超声。
43.如权利要求38或39或41中任何一项所述的超声增强型器械，进一步包括适配器，用于支撑超声检测器探针、或多检测器探针组，该超声检测器探针或探针组用于通过该针头通道传输超声脉冲或连续的超声。
44.如权利要求1至43中任何一项所述的超声增强型器械，进一步包括被结合在手动注射器内的超声检测器或多检测器组，所述超声检测器或检测器组被定位以与和该第一通道连通的该第一导管接触，该超声检测器或检测器组用于通过该针头通道传输超声脉冲或连续的超声。
45.如权利要求42或43所述的超声增强型器械，其中该超声检测器被电连接到超声控制器，该超声控制器用于控制一个或多个频率、持续时间、模式、或超声脉冲的功率，或用于显示。
46.如权利要求45所述的超声增强型器械，其中该超声控制器被结合在该控制器内。
47.一种用于检测超声增强型器械的系统，包括：
a.权利要求1至41中任何一项的超声增强型器械；
b.用于传输和接收脉冲的超声检测器；
c.超声显示器；以及
d.被电连接到部件(a)至(c)中的每一个的系统控制器，该系统控制器用于控制、检测或显示该针头的末梢尖端在该超声显示器上的位置。
48.如权利要求47所述的系统，其中该系统控制器被结合在该控制器中。
49.一种用于检测超声增强型器械的方法，包括：
a.从超声增强型器械的针头末梢尖端输送液体，该液体具有用于超声器械检测的选定的流速，该器械具有：
i.具有排放端的液体容器，
ii.被置于与该液体容器连接的液体排放装置，以便限定液体储存库，该排放装置用于将选定的压力施加到该液体储存库中的液体，以将所述液体通过该排放端从该储存库中排出，
iii.第一导管，具有入口端和出口端、并限定两者之间的第一通道，该入口端被置于该液体容器的排放端，该第一通道与该储存库连通；
iv.针头，具有接头端和末梢尖端、并限定两者之间的针头通道，该接头端被置于该第一导管的出口端，该针头通道与该第一通道连通；
v.被可操作地连接到该液体排放装置的液体供应装置，用于可选择地将该选定的压力施加到该液体，
vi.借此该选定的压力将该液体通过该液体容器的排放端排出，并通过该第一通道和该针头通道行进第一流程，用于以选定的液体流速从该末梢尖端排出；
b.从超声检测器传输超声脉冲；
c.通过该超声检测器接收该超声脉冲；并且
d.检测被从该末梢尖端排出的液体。
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