CN102946789A - 用于测量体内气囊尺寸的诊断用具和方法 - Google Patents
用于测量体内气囊尺寸的诊断用具和方法 Download PDFInfo
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Abstract
本发明提供了用于测量体内气囊扩张轮廓的方法。该方法包括:提供具有至少一个感测元件的气囊作为诊断设备,其中至少一个感测元件以表示气囊尺寸的至少一种属性为特征;测量至少一种属性来获得观测属性值;以及基于观测属性值估计气囊尺寸和气囊扩张轮廓。还提供了用于测量体内气囊扩张轮廓的诊断用具。诊断用具包括:诊断设备;用于测量属性的观测属性值的测量模块;和用于处理观测属性值来估计气囊扩张轮廓作为一个或多个输出的处理器模块。
Description
相关申请的交叉引用
本申请要求由Gopinathan在2010年9月17日提交的美国临时专利申请号61/383744的利益,而且还要求由Gopinathan等人在2010年6月13号提交的印度临时专利申请号1636/CHE/2010的外国优先权的利益,这两个申请标题都为“Systems and Methods for Measurements of LumenParameters”,其公开内容通过引用被并入本文。
技术领域
本发明通常涉及医疗诊断的领域,且更具体地涉及气囊导管。
背景
如在医疗诊断中使用的导管是指可被插入到身体腔、管道或血管内(本文通常称为体腔)的管。导管用在几种临床程序中,并允许流体和气体的引流、给药,或通过外科手术器械进入不同的体腔中。将导管插入所期望的体腔中的过程被称为导管插入。
被称为气囊导管的一种特定种类的导管在其顶端具有可充气的“气囊”,其在导管插入程序期间被用来放大身体内的狭窄的开口或通道。在医疗程序期间,放气的气囊导管被定位在体腔中,气囊被充气以执行必要的程序操作,并再次被放气以便被移除。
气囊导管也在血管成形术期间在支架的部属中被使用。对于这些程序,气囊导管包括在气囊上的预先安装的支架。当气囊被充气时,支架也被扩张。当气囊被放气时,支架在动脉中留下来,并且气囊导管可被移除。结合气囊导管使用的支架被称为气囊扩张支架。
在气囊血管成形术和支架部署期间,通过设置在经受程序的受验对象的身体外的装置将压力施加到包含在气囊中的流体来使气囊扩张。在这两个程序中,知道气囊扩张了多少在临床上是重要的。在血管成形术中,气囊扩张将直接与气囊周围的血管的被扩张的壁相关。在支架部署中,气囊扩张直接与其周围的支架的扩大的尺寸相关。
每个气囊基于气囊的物理特性伴随有压力相对于气囊直径的标称映射。然而,气囊的实际扩大的直径也取决于各种因素,例如斑块形态(钙化相对于非钙化)、斑块负荷(斑块的量),且因此由壁提供的阻力变化。气囊也由半柔性材料制成,且气囊因此可逆着增加的压力纵向延伸或在阻力较低的区域中扩张较多并在提供更高的壁阻力的区域中扩张较少。因此,这个映射不是气囊的扩大的尺寸的可靠测量。
目前,存在被发展来获得在扩张后的气囊直径的如下所述的一些技术,但由于上文提到的原因,它们被限制在那个范围内。
WO2010042653提供了用于使用具有可充气的主体的可伸缩的有源集成电路的系统、设备和方法。本发明允许这样的操作特征与身体结构例如管腔的内壁直接接触,以及对于测量和治疗的供给是有用的。
CN 201223393涉及带刻度的长度测量气囊导管,其包括多通接头、外管和内管。带刻度的长度测量气囊导管的特征在于,多个金属环被布置在气囊中的外管上以形成刻度。外管上的金属刻度是清晰的并在X-射线中可见,并可测量病理改变的长度,这对于作出关于诊断和治疗和外科手术的决定是有用的。
WO2008042347提供了用于使用智能气囊导管来诊断和治疗狭窄管腔的技术。智能气囊导管包括压力和直径感测特征以及反馈系统以控制气囊的扩张。管腔的周围压力使用位于导管的远端上的多个压力传感器被检测并被显示在监视设备上。周围压力的结果用于将导管的远端定位在狭窄的管腔内。气囊的被控制的渐进的或逐步的扩张出现。压力传感器检测气囊外的管腔的周围压力和气囊内的压力。距离传感器测量导管的中心和扩张的气囊表面之间的距离。气囊在不同的横截面处的直径被确定并被显示在监视设备上。气囊的容积和狭窄的管腔的腰部被确定。扩张的速率根据由压力传感器和距离传感器提供的输入而继续。
US2008033316提供了用于测量任何中空器官(例如,血管)中的横截面面积和压力梯度的系统、导管和方法。这样的系统的一个实施方案包括:能够被引入到目标部位中的阻抗导管;溶液输送源;恒定电流源;气囊充气控制设备;以及数据采集和处理系统,其从导管接收传导率和/或压力梯度数据,并计算目标部位的横截面面积。在一个实施方案中,导管具有沿其纵轴的可充气的气囊,因此实现任何材料的解体,引起在目标部位处的狭窄和/或在目标部位中的可选的支架的膨胀和输送。
WO2005070061提供了用于测量生理特征的系统,其用于治疗在食管中的异常粘膜,包括具有在导管的远端上的可充气气囊的尺寸测量设备,所述可充气的气囊使用扩张介质被充气以使气囊扩张来接合食道的壁,使得内部横截面可被计算或测量。尺寸测量设备还可包括用于传送扩张介质的输液源和用于测量导管内的扩张介质的数量和压力的装置。
WO0137897提供了用于测量患者体内的预选的内部开口的尺寸测量以提供预选的内部开口的第一和第二拉伸直径的快速和精确的确定的导管和方法。尺寸测量导管和方法可被利用来确定适当尺寸的设备被定位在预选的开口中。
US6010511提供了用于确定体腔的横截面尺寸(例如血管的直径)的方法和装置。根据一个示例性的方法,首先通过给在管腔内的气囊导管充气直到气囊直径匹配管腔直径来测量血管的直径。充气可以在非常低的压力下并受到管腔的约束,或可以可选地通过监测管腔内的流量来被控制。气囊包括至少一个测量元件,其指示被扩张的气囊横截面面积、周长或直径。
US5397308提供了用于血管成形术等的改进的气囊导管,其用于在插入体内后测量气囊的充气。一对电极以间隔开的关系安装在气囊内壁内,使得当气囊内的内部区域被具有导电流体的气囊的充气改变时,电极监测电极之间的变化的电阻。电极通过导管连接到外部电测量电路,其用于测量导电流体的电阻的变化,并因此确定的气囊充气的量。电阻的变化是由于气囊的直径的平均变化以及气囊的平均纵向扩张。
上面描述的方法被医师使用来通过涉及测量信息、知识和经验的映射以及从X射线图像(血管造影照片)的气囊直径的眼球估计的技术的组合确定被扩张的气囊的直径。
然而,继续存在对进一步改进关于气囊尺寸的测量的方法和技术的需求,以准确地输送支架和其他程序,因为今天可用的技术目的都在于在仅仅几个(通常为一个)特定的位置获得气囊直径测量,并因此从本质上遭受估计误差。有证据显示与扩张的血管造影估计和如通过系统例如IVUS(血管内超声波)和OCT(光学相干断层摄影)测量的实际扩张的差的相关性,因此用于测量气囊扩张和其尺寸的改进的技术是需要的。
简要描述
在一个方面中,本发明提供了用于测量体内气囊扩张轮廓的方法。该方法包括:提供具有至少一个感测元件的气囊,其中至少一个感测元件以表示气囊尺寸的至少一个属性为特征;测量至少一种属性以获得观测属性值;以及基于观测属性值估计气囊尺寸和气囊扩张轮廓。
在另一个方面中,本发明提供了用于测量体内气囊扩张轮廓的诊断用具。诊断用具包括:具有至少一个感测元件的气囊,其中至少一个感测元件以表示气囊尺寸的至少一个属性为特征;用于测量属性的观测属性值的测量模块;以及用于处理观测属性值以估计气囊扩张轮廓作为一个或多个输出的处理器模块。
在另一方面中,本发明提供了诊断设备,其包括具有至少一个感测元件的气囊,所述感测元件用于测量至少一个气囊扩张轮廓。
附图的简要说明
当参照附图阅读下面的详细描述时,本发明的这些和其他的特征、方面、和优点将被更好地理解,在附图中相似的符号在全部附图中表示相似的部分,其中:
图1是体现为气囊导管的示例性的诊断设备的图示,所述气囊导管可被放置在体腔中的体内,用于测量气囊扩张轮廓;
图2是具有作为感测元件的电阻元件的诊断设备的另一示例性实施方案的图示;
图3是具有被完全集成到气囊的材料中的电阻元件的诊断设备的另一示例性实施方案的图示;
图4是诊断设备的另一示例性实施方案的图示;
图5-7是诊断设备的其它非限制性的示例性实施方案的图示;
图8是用于测量体内气囊扩张轮廓的示例性方法的步骤的流程图表示;
图9是在属性和用于测量体内气囊扩张轮廓的气囊尺寸之间的图形表示;以及
图10是用于测量体内气囊扩张轮廓的诊断用具的示例性实施方案的图示。
详细说明
除非上下文清楚地另有指示,如本文中并在权利要求中所使用的,单数形式“a”“an”“the”包括复数的提及。
如本文中所使用的,管腔意指受验对象例如人的任何管状结构化构件例如动脉或肠的内部空间。例如,血管的内部例如血液流动所通过的动脉或静脉中的内部空间被认为是管腔。类似地,管腔也可表示细胞构件或结构例如内质网的内部空间。
如本文中所使用的,血管成形术是机械地加宽狭窄的或阻塞的血管以帮助改善在血管的血液流动的技术。血管成形术可还涉及在体腔内的支架部署。支架由细金属丝材料例如铂组成,所述材料可以通过细导管被插入,以及一旦它们被引导到适当位置中就可被扩张成预定的形状。
本发明的方面涉及用于加宽狭窄或阻塞的血管的气囊导管和用来在体腔中部署支架的气囊扩张支架,作为医学治疗的一部分。与导管的这种使用相关的程序在本文中通常被称为医疗程序。
如上面在本文中所解释的,为了准确地诊断在身体通道如血管中的收缩并同时执行气囊的收缩和扩张和/或将支架定位在体腔中,知道气囊被充气多少很重要。气囊扩张测量越准确,诊断和医疗程序就越好。
本发明的示例性的实施方案包括感测元件或以导管气囊或血管成形和支架输送气囊的材料的感测元件,其以可测量的方式对气囊的扩张作出反应。例如,当气囊膨胀时,气囊的由于扩张而变化的至少一种属性被测量,并且气囊的扩张轮廓因此被推断出。被测量的属性可以是电压差、电阻,或谐振频率、或是可以被测量和表示气囊尺寸的任何其他的属性。
本发明的示例性的实施方案在图1中被示为包括具有至少一个感测元件16的气囊14的诊断设备12,传感元件16用于测量至少一个气囊扩张轮廓。在示例性实施方案中的感测元件16是以沿着气囊的表面上的圆周的至少一部分被嵌入的弹性电阻元件的形式。弹性电阻元件的两个端点形成端子A和B,并起两个间隔开的电极18的作用。两个间隔开的电极为用于进行电测量(其用来产生气囊扩张轮廓)的子元件,同时气囊经由导管22放置在体内并在医疗程序期间由加压流体20通过管24扩张。在示例性实施方案中的感测元件被示为环状结构,但用于放置感测元件的其它修改是可能的,并被包括在本发明的范围内。
一些示例性的修改包括:感测元件是气囊整体的组成部分,其中感测元件可通过已知的技术合并到用来构造气囊的材料中。一系列聚合物——包括硅橡胶、乳胶、天然橡胶胶乳和热塑性弹性体——被用来构造导管。在另一更特定的示例中,感测元件为集成在气囊中的压电材料,其中电场的变化通过压电材料被感测到。在另一特定的实施方案中,感测元件是嵌在气囊壁中的电容元件。电容元件可通过将电介质夹在气囊壁的两层之间被合并。当气囊的直径变化时,该电容元件将感测电容中的变化。在另一实施方案中,使用电感元件例如线圈而不是电阻元件。在又一实施方案中,气囊合并张力可以被测量的材料。气囊的壁的张力与它被扩张到的直径直接相关。因为存在绷紧的气囊壁将振动的自然频率,这样的张力可通过诸如声音振动的手段被间接测量。
在另一示例性实施方案中,使用单个感测元件,而在又一示例性实施方案中,可使用多个感测元件。在如图1中示出的示例性实施方案中,感测元件被合并,作为被嵌入或附接到气囊的内表面或外表面的分立元件(如环或线圈)。在特定的示例中,多个这样的环可沿纵轴来获得扩张轮廓。感测元件可被安装在气囊的表面上或可存在于气囊内。在另一实施方案中,导电油墨被“涂覆”在气囊的内表面或外表面上,并被用作感测元件。不传导无线电的油墨也可被用在气囊上,实现放置这样的电活性元件的方法。这样的元件也可通过使用导电性油墨的技术来构造。不传导无线电的油墨也可用来感测气囊的尺寸。
在类似于环形感测元件的另一实施方案中,一个元件或多个元件可被放置在平行于纵轴的气囊表面上,以通过测量在沿气囊的轴长度的不同的点处的直径来测量气囊的纵向扩张,以获得气囊扩张轮廓。
例如,两个或更多的电极沿其长度放置在电导导管中。当高频低振幅恒定电流穿过外部电极以产生电场时,任何内部电极对之间的电位差被用来计算气囊尺寸并产生气囊扩张轮廓。
图2是具有作为感测元件16的电阻元件的诊断设备12的另一示例性实施方案的图示,所述感测元件16由可以是气囊的构造材料的一部分的导电材料组成。多个这样的元件可沿纵轴被使用。
图3是诊断设备12的另一示例性实施方案的图示,所述诊断设备12具有被完全集成到气囊的材料中的电阻元件16。本领域的技术人员将认识到,在这样的配置中,整个气囊表面是导电的,以及端子电极在不同的点被附接到气囊的材料。在本实施方案中,电阻可在任何两个电极之间一次被测量。
图4是另一示例性实施方案12的图示,其中,电流被一次注入一对电极26和/或27之间,并且在多个电极28处发展的电压被测量。如所示,由参考数字26表示的第一对电极为环形电极,以及由参考数字27表示的第二对电极为带形电极,其布置成平行于气囊的轴。在示例性实现中,多个对中的一对电极(26或27)一次被激励。通过使用两对电极,在所有方向上的气囊扩张可以被确定。本领域技术人员将认识到,测得的电压分布可用于径向和纵向地绘制整个气囊扩张轮廓。如所示出的,用于注入电流的端子可为特殊的电极,其可以是较大的,例如在图4中所示的高度导电的环或带。
图5是具有纵向放置的测量在长度上的扩张的感测元件16的另一示例性实施方案12的图示。虽然只有一个发送元件16被示出,在特定的实现中,可使用多于一个的感测元件。
图6是另一示例性实施方案12的图示,其中考虑到气囊的不同部分可以扩张不同的量以及来自多个元件的测量将产生气囊扩张轮廓,多个感测元件16被间隔开地放置,覆盖气囊的不同的横截面面积,以获得气囊扩张轮廓。
图7是具有感测元件16的另一示例性实施方案12的图示,所述感测元件16的形式是包括包封电介质材料的两个同心圆柱形外壳的电容元件。如所示出的,一个端子被连接到同心外壳的外层,以及一个端子被连接到同心外壳的内层。可以使用被放置在气囊的体积内的多于一个这样的同心外壳。
应当指出的是,本文中所描述的实施方案为非限制性示例,其他的修改可根据类似的原理实现,并在本发明的范围内。
本发明的一个方面是用于测量体内气囊扩张轮廓的示例性方法,该方法通常通过图8的流程图30描绘。该方法包括提供具有至少一个感测元件的气囊的步骤32,其中至少一个感测元件以表示例如图1的实施方案的气囊尺寸的至少一种属性为特征。该方法另外包括用于测量当气囊在体内扩张时的至少一种属性以获得观测属性值的步骤34;以及用于基于观测属性值估计气囊尺寸、在气囊扩张时气囊尺寸的变化、以及气囊扩张轮廓的步骤36。该方法包括测量在单个位置或在多个位置处的观测属性。
本领域的技术人员将认识到,气囊尺寸的变化表示气囊的扩张。在一个示例性实施方案中,该方法另外包括用于估计气囊尺寸的变化的与预定的位置有关的方向的步骤38。例如,气囊扩张轮廓可被估计为沿气囊的一个轴例如纵轴的尺寸。
如本文中所提到的属性可为在图1的至少两个电极之间的电阻或电阻抗。如本文所使用的阻抗是指元件的电阻(电阻性阻抗)。然而,如本领域中的技术人员将认识到的,可测量的特性也可以是弹性电阻元件的电感(电感性阻抗)或电容(电容性阻抗),并且被认为是在本发明的范围内。
现在参照图1的实施方案,两个端子A和B用于通过绘制穿过导管的细线来测量感测元件的电阻抗。当气囊膨胀时,感测元件随其一起膨胀。因此感测元件的圆周长度增加。同时,存在感测元件的横截面面积的减少(总容积是恒定的)。这两种变化都导致阻抗中的增加。
在图9中示出了图形表示40,其示出了在轴44上的所测得的电阻与在轴42上的气囊直径之间的关系。通过这种关系,所测得的电阻值50(观测属性值)可直接被映射到气囊的直径48(尺寸)。本领域技术人员将认识到,测量没有受到血管的周围壁的性质的影响,也没有受到气囊内的流体的确切压力的影响,并因此比现有技术的方法更准确。如上面在本文中提到的,本发明的方面包括获得径向扩张轮廓以及纵向扩张轮廓。气囊的纵向扩张是有用的测量,因为它将防止气囊鼓起而超出支架,这通常会导致对相邻的血管壁的损坏。
本发明的另一示例性实施方案是如在图10中示出的用于测量体内气囊扩张轮廓的诊断用具52。诊断用具52包括具有感测元件的气囊54,其中感测元件以表示气囊尺寸的至少一种属性为特征,如参考图1解释的。诊断用具52另外包括用于测量属性的观测属性值的测量模块56和用于处理观测属性值以估计气囊扩张轮廓作为一个或多个输出的处理器模块58。处理器模块还被配置成比较观测属性值和期望属性值,所述期望属性值对于另外的分析和引导医疗程序是有用的。在一个示例性的实施方案中,处理器模块还被配置成估计气囊尺寸的变化关于预定的位置的方向。在示例性实施方案中,诊断用具52还包括显示模块60,以显示一个或多个输出。本文所述的测量模块56还被配置成测量在医疗程序期间可能发生的气囊扩张轮廓中的变化。测量模块56还被配置成在一个实施方案中在单个位置处测量观测属性,而在另一示例性实施方案中在多个位置处测量观测属性。
如本领域技术人员将认识到的,如在本文中所描述的诊断设备、方法和诊断用具增加了医疗程序的有效性。本文所描述的实施方案也可用在除了心血管例如周围动脉疾病以外的其他程序中。另外,示例性实施方案可以用在任何应用中,其中气囊状结构用来使用被抽入的流体或气体来扩张空腔以扩张气囊。
虽然本文仅示出和描述了本发明的某些特征,本领域中的技术人员将会想到许多修改和变化。因此,应当理解,所附的权利要求旨在涵盖落在本发明的真实精神内的所有这样的修改和变化。
Claims (34)
1.一种用于测量体内气囊扩张轮廓的方法,所述方法包括:
提供具有至少一个感测元件的气囊,其中所述至少一个感测元件以表示气囊尺寸的至少一种属性为特征;
测量所述至少一种属性以获得观测属性值;以及
基于所述观测属性值估计所述气囊尺寸和所述气囊扩张轮廓。
2.如权利要求1所述的方法,其中所述至少一个感测元件包括至少两个电极。
3.如权利要求2所述的方法,其中所述至少一种属性是所述至少两个电极之间的阻抗。
4.如权利要求2所述的方法,其中所述至少一种属性是在所述至少两个电极之间测量的电压差。
5.如权利要求2所述的方法,其中所述至少一种属性是所述至少两个电极之间的谐振频率。
6.如权利要求1所述的方法,其中所述至少一种属性用来测量所述气囊尺寸的变化。
7.如权利要求6所述的方法,还包括估计所述气囊尺寸的变化的与预定的位置有关的方向。
8.如权利要求6所述的方法,其中所述变化表示所述气囊的扩张。
9.如权利要求1所述的方法,其中所述气囊扩张轮廓是沿所述气囊的一个轴的尺寸。
10.如权利要求1所述的方法,还包括在单个位置处测量所述观测属性。
11.如权利要求1所述的方法,还包括在多个位置处测量所述观测属性。
12.一种用于测量体内气囊扩张轮廓的诊断用具,所述诊断用具包括:
气囊,其具有至少一个感测元件,其中所述至少一个感测元件以表示气囊尺寸的至少一种属性为特征;
测量模块,其用于测量所述属性的观测属性值;以及
处理器模块,其用于处理所述观测属性值以估计所述气囊的扩张轮廓作为一个或多个输出。
13.如权利要求12所述的诊断用具,还包括显示模块以显示所述一个或多个输出。
14.如权利要求12所述的诊断用具,其中所述处理器模块还配置成比较观测属性值和期望属性值。
15.如权利要求12所述的诊断用具,其中所述至少一个感测元件包括至少两个电极。
16.如权利要求15所述的诊断用具,其中所述至少一种属性是所述至少两个电极之间的电阻。
17.如权利要求15所述的诊断用具,其中所述至少一种属性是所述至少两个电极之间的电容。
18.如权利要求15所述的诊断用具,其中所述至少一种属性是所述至少两个电极之间的谐振频率。
19.如权利要求12所述的诊断用具,其中所述至少一个感测元件被安装在所述气囊的表面上。
20.如权利要求12所述的诊断用具,其中所述至少一个感测元件存在于所述气囊内部。
21.如权利要求12所述的诊断用具,其中所述测量模块还配置成测量所述气囊扩张轮廓的变化。
22.如权利要求21所述的诊断用具,其中所述处理器模块还配置成估计所述气囊尺寸的变化的与预定的位置有关的方向。
23.如权利要求12所述的诊断用具,其中所述测量模块还配置成在单个位置处测量所述观测属性。
24.如权利要求12所述的诊断用具,其中所述测量模块还配置成在多个位置处测量所述观测属性。
25.如权利要求12所述的诊断用具,其中所述至少一个感测元件是所述气囊的整体的组成部分。
26.如权利要求25所述的诊断用具,其中所述至少一个感测元件是集成在所述气囊中的压电材料。
27.如权利要求25所述的诊断用具,其中所述至少一个感测元件是嵌在所述气囊的壁中的电容元件。
28.如权利要求12所述的诊断用具,其中所述至少一个感测元件是沿着所述气囊的表面上的圆周的至少一部分嵌入的弹性电阻元件。
29.一种诊断设备,其包括气囊,该气囊具有用于测量至少一个气囊扩张轮廓的至少一个感测元件。
30.如权利要求29所述的诊断设备,其中所述至少一个感测元件包括至少两个电极。
31.如权利要求29所述的诊断设备,其中所述至少一个感测元件是所述气囊的整体的组成部分。
32.如权利要求31所述的诊断设备,其中所述至少一个感测元件是集成在所述气囊中的压电材料。
33.如权利要求31所述的诊断设备,其中所述至少一个感测元件是嵌在所述气囊的壁中的电容元件。
34.如权利要求29所述的诊断设备,其中所述至少一个感测元件是沿着所述气囊的表面上的圆周的至少一部分嵌入的弹性电阻元件。
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AU2011267954B2 (en) | 2014-07-24 |
JP2013534841A (ja) | 2013-09-09 |
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