CN1049288A - 医疗器械的定位装置 - Google Patents
医疗器械的定位装置 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
- A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
- A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01V—GEOPHYSICS; GRAVITATIONAL MEASUREMENTS; DETECTING MASSES OR OBJECTS; TAGS
- G01V3/00—Electric or magnetic prospecting or detecting; Measuring magnetic field characteristics of the earth, e.g. declination, deviation
- G01V3/08—Electric or magnetic prospecting or detecting; Measuring magnetic field characteristics of the earth, e.g. declination, deviation operating with magnetic or electric fields produced or modified by objects or geological structures or by detecting devices
- G01V3/10—Electric or magnetic prospecting or detecting; Measuring magnetic field characteristics of the earth, e.g. declination, deviation operating with magnetic or electric fields produced or modified by objects or geological structures or by detecting devices using induction coils
- G01V3/104—Electric or magnetic prospecting or detecting; Measuring magnetic field characteristics of the earth, e.g. declination, deviation operating with magnetic or electric fields produced or modified by objects or geological structures or by detecting devices using induction coils using several coupled or uncoupled coils
- G01V3/105—Electric or magnetic prospecting or detecting; Measuring magnetic field characteristics of the earth, e.g. declination, deviation operating with magnetic or electric fields produced or modified by objects or geological structures or by detecting devices using induction coils using several coupled or uncoupled coils forming directly coupled primary and secondary coils or loops
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2051—Electromagnetic tracking systems
Abstract
本发明的器械位置测定装置包括一个与器械结
合在一起插入物体内并在体内发射信号的发射元件、
一个至少含有定向接收已发射信号的接收元件的信
号功率检测装置、一个与接收元件耦合的信号功率强
度检测装置用以对每一耦合到测量装置上的接收元
件产生一个功率强度值、一个计算装置用以根据从每
个接收元件接收到的信号所检测到功率强度值来计
算从接收元件到发射元件的距离、以及一个与计算装
置耦合的指示装置用以指示上述算出的距离以使器
械在物体内定位。
Description
本发明涉及一种用于导管和其它类似的医用的及其它器械插入体内或在体内使用时的定位装置。
导管是一种医疗器械,通常包括一个刚性的或有挠性的能够置入人体或动物体内用以将气体、液体或药剂引入机体或从中取出的管状体。该管状件通过现有的开口和通道或者通过在皮肤上所做的切口进入静脉、动脉或者其它类似的体内腔体和通道进入体内到达需要治疗的部位。医生的熟练技术和崇高的职责训练是完全决定着导管的正确使用。
已知的导管的种类是按专门的目的由设计上来区分的。比如有橡实状顶端的导管是用于输尿管肾盂造影术,以封闭尿道口并防止在注射不透明介质时或之后从输尿管回流;血管造影述用导管是一种通过它注射造影剂(即不透X射线),以对某器官的血管系统进行显形,这种导管可以有予成形的端部,以便于从远端进入位置有选择的定位(如肾或冠状血管),因此,这种导管还可根据进口或终端的位置来命名,如股肾动脉导管、肱冠状动脉导管,等等;局部导管是一种非常细的导管,它能够通过细小弯曲的血管将化疗药物直接送入脑肿瘤部位;斯万一甘茨氏(Swan-Ganz)导管是一种端部带有气囊以测量肺动脉压的软的定向流动的导管,它进入静脉系统(通过重要的内颈静脉或锁骨下静脉),在血流的引导下进入上腔静脉,右心室和前庭并进入肺动脉,除此以外,还有更多的导管供医生使用。
一个导管最主要的性能在于其端部在体内定位的准确程度,然后才是对于所使用的导管作用在最易接受施加治疗的组织或部份上的输送和排放过程。最通常的操作是导管由医生置人体内后用X线检查,以便保证导管的端部正确定位。这些操作步骤将导致时间延误,增加了费用,并给治疗过程带来不便。另一种方法可不必做X光检查,而依靠医生的熟练技巧获得准确的定位,这种情况当需要抢救时就会发生,因为X光检查会造成不可容许的延误。
显然,具有上述优点的装置还能够用于定位医疗或其它领域内使用的其它器械。
因此,本发明的一个目的在于提供一种定位装置,它能够在器械插入人体或其它物体内时,确定器械或任何其它装置选定部位的位置。
本发明又一个目的在于提供一种适合于定位导管端部或其它医疗器械或装置的定位装置,所说的器械与定位装置装配在一起进入人或动物体内。
本发明最主要形式包括一个器械位置的确定装置,它包括一个与器械结合在一起插入物体内并在体内发射信号功率的发射元件,一个至少有一个定向的接收发射出来的信号功率的接收元件的信号功率检测装置,一个与接收元件耦合的信号功率强度检测装置,以便对每一个耦合到测量装置上的所说的接收元件产生一个功率强度值,一个计算装置,它用由所说的每一个接收元件的接收到的信号测出的功率强度值来计算由接收元件到发射元件间的距离,一个耦合到所说的计算装置上指示装置,该装置为设备的操作人员提供计算所得的距离指示,以便器械在物体内定位。
现在说明本发明的一个最佳实施例,但对于那些本领域内的普通技术人员都明白本发明并不限于所公开的某一个特征或多个特征的组合。
图1表示一个包括调谐线圈和整体的电磁源的导管;
图2表示单线圈接收装置及辅助的控制和处理装置;
图3表示三轴线圈接收装置;
图4表示按照本发明处于使用状态的导管;
图5表示线圈接收元件的一个实施例;
图6表示双线圈接收元件结构的实施例;
图7表示手持式距离测量装置一个实施例的剖面图;
图8表示手持式距离测量装置的电路框图;
图9表示微处理机测量程序的流程图。
图1所示的发射元件的实施例包括围绕导管2的端部按螺旋形缠绕的细导线1。这个线圈可以是一圈也可以多圈,且理论上可以是最细的导线,这样用少量的匝数来提供能够与电容性元件相匹配的复合阻挠,并与电路3的其余元件结合形成一个线圈,从而以所需频率最高效地发射。按最佳实施例,所选频率为40KHz,然而,对本领域内普通技术人员应该明白,器械通过所插入的体内呈现最少的衰减和可以绕制特定匝数的线圈,线径和线圈直径的任何频率都是可能的。这种类型的发射装置的变换可以是包括能够沿特定方向或全向发射的电磁场的电感和电容元件的芯片。另外,发射元件可以包括具有附加的串联电容作为电磁功率发射器的一种直线型导线结构。
在本实施中,振荡电路包括一个以予定电压振幅的持续工作的40KHz石英驱动的方波振荡器。然而,应该理解振荡器可以包括许多的其它频率或其组合进行工作的不同的电路装置,且发射功率可以做成可调的,以便装置的发射元件可以与接收元件相匹配,以校准所取得的距离测量值。
工作频率及所需的信号强度的选择决定于电磁幅射穿过人体组织和骨骼的额定阻抗,以及接收元件工作要求通过所使用用范围所需的信号功率,因此,需要较大的振荡器信号强度或适当的选择频率,以便在所使用的环境中取得本发明的最佳结果。
导管是一种无菌器械,这就需要将线圈作为导管的一部份密封起来,最好采用与人体组织不起化学反应的材料。然而,对于线圈结构的进一步的实施来说明将其密封在导管中或沿其长度方向的各点上是可能的。
此外,振荡器装置可以插入导管的端部内,且在这些情况下,发射装置只能用一次。
在这种类型的振荡器装置使用时,由于需要减少能量消耗,它可以是不连续的,即采用编码或非编码方式的脉冲工作。
因此,多种的振荡方法能够在同一人体内提供多个发射装置,当然,在达到正确定位后,如果连接在发射元件上的振荡器位于体外,它可能被中断;或者,如果振荡装置全部位于体内,则由一个相应于外部的通信装置的接受装置可以控制它中断、启动或执行其它功能。
这也是可以理解的,也可以使用具有发射元件的附加装置,如可以呈现与电磁发射元件具相同特性的超声传感器。
图2所示是单个线圈的发射接收元件,它包括一个导线缠绕成的线圈20,并图解地表示了一个电容性元件21,以说明线圈的调谐性能。在本实施中,接收线圈的调谐频率为40KHz,它的输出送入放大器22,并由电路装置和微处理机23进一步处理,以提供相对于发射线圈与接收线圈(组)之间的距离数据,该数据用显示装置24或音响装置25显示给医生,由此其能够在导管通入物体内部的过程中跟踪和控制它。
显示可以有多种多样形式,在本实施例中,如图4中在45上所提供的一系列的灯光显示为人们提供了可读的发射线圈的方向和距离的输出,所说的发射线圈是装在相对于在物体外的接收线圈的导管的端部上。此外,声响指示装置25包括产生高重复率的喀啦声,表示接收线圈的近端已靠近导管的端部。使用一个线圈只能提供在一个平面内的位置指示。
图3表示三个线圈的接收装置,线圈沿轴向彼此正交的方向上配置,在接收和放大后,在三个不同平面上接收到表示功率大小的三个分离的信号,它们能够由中央处理器用来计算并显示发射元件与接收元件间的距离。这些信号的显示可以有许多种形式,在本实施例中,如在图4的45上,计算机的图形显示提供了医生把导管送入病人内相对于手持接收线圈的X和Y位置的反馈。距离测量提供了Z轴的值。如果所使用的线圈在导管的端部上,也可以确定并显示线圈的方向,如果对所做的治疗要求较高的话。这就要求处理器的附加程序提供这一特性。
图4表示插入病人42的胸腔内的装有发射线圈41的导管40,尽管没有明确地表示,发射元件是由体外的能源/振荡器电路43供源的,然而,能源/振荡器电路可以与发射线圈是一体的,因此,它可能在导管的端部或任何位置上整个地插入物体内。
如图所示的接收线圈组是与手柄46组合在一起。通过在人体体表附近移动手柄46,直到从其发出适当的音响信号来确定发射元件41的位置。当导管端部定位时,计算和显示发射元件和接收元件之间的深度,以此提供导管端部距离体表的深度,籍此帮助医生确定发射装置在体内的精确位置。医生所具有的人体器管的解剖学及结构方面的知识与该装置所提供的信息相结合使医生能够更加确信导管的位置。
这种方法的实际应用的一个实例就是将导管/软管插入气管,以便把麻醉剂或气体直接送入肺部,而不会意外地将导管插入食管。
这种导管的途径是径喉部进入气管,并且在于分支点之上可以跟踪导管的深度,使医生更加确信导管已经进入人体的正确位置。
具有同样深度的导管途径分开之处,导管端部位置可以由它在体表上的位置确定。
图5是接收线圈的一个实施例,其中线圈用0.12毫米(外径)的导线在7毫米宽的绕线架上绕成8.5毫米的直径。
图6a表示双线圈探测器结构的实施例的顶视图,图6b表示三个线圈的检测器的顶视图。注意每个线圈的纵轴互成90°。
图7表示手一个持式装置实施例的剖面图,它包括一个具有大体上光滑的表面71的体身70,在它的上面及内部装有图6a或图6b所示的检测线圈72。这些线圈联接到装在装置体身70内的放大电路73上,然后再接到手持式装置的计算电路74和显示电路75上。一个成形材料制成的凹面屏蔽罩76安置在表面71的上面并围绕该表面,所说的屏蔽罩具有将发射线圈的接收限制在仅仅从表面71进入手持式装置体内的特性。在本实施例中7所说的屏蔽罩包括一个杯状的类似的结构,它由镍铁高导磁合金或者其它类似的高导磁性、低饱和磁合金制造。电池77对电路73、74和显示装置75供给直流电源,电池可以是充电型的。
图8表示手持式装置的电路方框图。可以使用二个或三个线81圈、82和83,每个线圈被调谐到由发射线圈发射40KHz信号脉冲的最佳转换状态。当它们分别与电容元件84、85和86结合在一起时,线圈81、82和83在该频率上产生共振。正比于接收信号强度的信号分别由放大器87、88和89(NE5534)放大,在本实施例中,放大器的增益为200。此外,也可以使用滤波电路(未画出),用以限制来自线圈的接收和放大的信号的带宽和减少外部信号和放大器噪音的影响。放大的交流信号分别由转换器90、91、92(LF336)转换成直流信号,然后进入人多路转换器93(4052),多路转换器分别将在线圈上检测到的信号值依次加到12位模数转换器(7109)上。由参考装置95提供的直流参考电压,检测到的线圈号可以对照该参考电压比较和校准。然而,这种可变直流电压参考值的主要作用在于通过可变电阻99提供一个调节装置,使得计算距离被调整到反映到线圈和发射元件间的距离。
微处理装置96(87C51)提供了一个沿连接线97到多路转换器93的控制信号,这就是说每个按直流电压形式表示的接收线圈信号和参考电压依次加到模数转换装置94上。
微处理装置96还提供了一个沿连接线98到到模数转换装置94的控制信号,该信号能使数字数据由转换器94经接口98a流向微处理机,该数据是在三个线圈81,82和83上接收到直流电压信号的数字表示形式,同样还有直流参考电压95。这些数据由微处理机用于计算由接收线圈组到发射元件间的距离。距离算出之后,微处理机可以修正所显示的距离值,以便反映接收线圈距发射线圈和接收线圈距手持式装置表面71之间的差异。后面这个距离对医生来讲是最有用的。
图9表示微处理机测量程序的流程图和用于收集计算所需数据的各种数据输入的控制模块。步骤100是准备阶段,在该阶段,所有与贮存计算值有关的寄存器都被置于零位。且所有的选择线都被中断。接下去是步骤101,该步骤表示选择线97被置定,从而打开多路转换器93,使线圈82的直流信号值通过它到达模数转换器94。选择予置延迟控制线98后,使得在线圈81的表示电压信号的数字值经接口98a送到微处理机96的记忆存贮器内,并以值X表示。
步骤102除出线圈82的电压信号被转入微处理机记忆存贮器内,并由值Y表示外,与步骤101完全相同。
同样,如果使用线圈83的话,步骤103与步骤101、102相同,它的电压信号转入微处理机96的记忆存贮器内,并以值Z表示。
步骤104与步骤101、102、103一样,除出直流参考电压转入微处理机96的记忆贮存器内,并以值K表示外。
步骤105计算线圈公共的轴点到发射元件间的距离d,并按下式计算:
数值K、X、Y和Z分别从不同的贮存器中取得,并通过计算得出d值。
d值能够通过接口108在液晶显示器107上用三位有效数字表示,在形式上,例如10.5,表示10.5公分。为了便于显示和读数,微处理机96仅以0.5毫米的间隔的增量显示距离,例如10.0-10.5-11.0,当d值大于10.0时,当d值大于10.0;当d值大小10.0,提供0.1毫米的增量,且每次转换提供一个时延,因此,在避免读错或者读数方式上造成不必要的困难,在读数时数值不变。
如前所述,K值表示直流电流参考值,并由改变电阻器99的值来改变。这种直接的显示的距离值的控制是最佳的,以便反映从发射元件到线圈的实际测量值。应该明白,发射元件的功率应该同样可以调整,如果参考电压是固定的话,然而,业已发现参考电压的调整是最有效的。
由于医生控制导管或类似装置送入病人体内不可能总是观察显示的距离测量值,所以也提供了深度的音响指示。微处理机的输出在流程内的步骤106内控制驱动音响传感器109,例如通过接口110的压电装置。
音响信号的正确形式只是为了方便起见,然而,业已发现,在从液晶显示器上确定距离值后,作为定时指示装置,在d值较小时就增加重复频率的恒定的声音脉冲量是最有用和可接受的(例如,1KHz,持续0.3秒)。
微处理机96也能够通过它的RS232C输出通道111输出所有的X、Y、Z、K和d值到另一个计算装置中去。
对于本专业技术领域内的普通技术人员应该理解发射元件也可以包括除线圈以外的其它元件,如与超声接收元件或元件组。还应明白,如图6a所示彼此成直角排列的两个电磁信号接收线圈也足以完成本发明的目的。
还应该明白,本发明的元件同样地用于大量医学和其它器械的定位上,并且有了它,就可用一个不插入的距离和位置指示装置,为操作者提供辅助保证。
例如,为各种方式的目的而置入体内的导管或塑胶管可以配有定位的、装配在导管中的的远距离驱动的发射元件。
Claims (19)
1、一种器械位置测定装置,包括一个与器械联在一起插入物体内并在其中发射信号功率的发射元件,一个信号功率检测装置,包括:
至少有一个定向地接收所发射的信号功率的接收元件;
一个联接到接收元件上的信号功率强度检测装置,以对联接到检测装置上的每一个所说的接收元件产生一个功率强度值;
一个计算装置,该装置利用所测得的每一个所说的接收元件所接收的功率强度值来计算由接收元件到发射元件间的距离;
一个联接到所说的计算装置上的指示装置,该装置为测定装置的操作人员提供计算所得距离的指示,由此器械可以在物体内定位。
2、按照权利要求1所述的器械位置测定装置,其中所说的器械是一个导管。
3、按照权利要求1所述的器械位置测定装置,其中每一个所说的接收装置所接收到的功率强度值由e1、e2....ep表示,由此,计算装置分别利用每个接收元件所接收到的功率强度按下式 确定发射元件与接收元件的距离。
4、按照权利要求1所述的器械位置测定装置,其中发射元件是一个激发后可发射电磁信号的线圈,和
所说的接收装置是一个连接在调谐电路内的线圈,通过调谐可接收所说的发射的电磁信号。
5、按照权利要求4所述的器械位置测定装置,其中所说的每一个接收元件彼此按不相同的方向定向,以便接收来自发射元件所发射的电磁信号的不同的功率强度。
6、按照权利要求5所述的器械位置测定装置,其中线圈发射予定的功率和频率的信号。
7、按照权利要求6所述的器械位置测定装置,其中予置频率为40Hz。
8、按照权利要求6所述的器械位置测定装置,其中信号功率强度测量装置包括一个用于放大调谐电路接收到的信号功率,由此,信号包括一个变化的模拟电压信号。
9、按照权利要求8所述的器械位置测定装置,其中信号功率强度测量装置进一步包括用于把每一个接收元件所接收的变化的交流电压信号转换成变化的直流电压的信号转换装置。
10、按照权利要求9所述的器械位置测定装置,其中信号功率强度测量装置进一步包括一个具有多输入端的信号选择装置,其输入端来自每个接收元件的信号转换装置,及一个输出端,该输出端用于选择输入信号之一送入输出端。
11、按照权利要求10所述的器械位置测定装置,其中信号功率强度测定装置进一步包括一个具有把输入耦合到信号选择装置的输出上的模数转换装置,该装置用于把变化的直流信号转换成表示由相应于接收元件的选择装置选择的信号功率强度的数字值。
12、按照权利要求11所述的器械位置测定装置,其中在信号功率强度测量装置和计算装置之间有一个联接装置,包括
记忆存贮装置,所说的计算装置包括一个控制装置,它控制信号选择装置将一个接收元件的信号功率强度送到信号功率强度选择装置的输入端,并控制将信号功率强度的数字值记录在记忆存贮装置内。
13、根据权利要求3和12所述的器械位置测定装置,其中计算装置计算从发射线圈到接收线圈间的距离。
14、根据权利要求1所述的器械位置测定装置,其中指示装置包括一个计算距离的可读显示。
15、根据权利要求14所述的器械位置测定装置,其中显示包括一个液晶数字显示装置。
16、根据权利要求1所述的器械位置测定装置,其中指示器装置包括一个计算距离的音响指示。
17、根据权利要求16所述的器械位置测定装置,其中音响指示包括一个在某一频率下开和闭的可听音调,在装置的测量范围内的距离的中心值附近,该音调的频率当距离值小时则增强,而距离大时则减小。
18、按照权利要求13所述的器械位置测定装置,其中信号功率强度测量装置包括一个可调的直流电压电源,它具有信号值K,和连接到信号选择装置输入端的输出,由此,控制装置控制信号选择装置打开或关闭直流电压到它的输出端的输送,进而计算装置按下式计算: 从发射线圈到接收线圈间的距离d,且能够通过调节K值将测量和显示的距离调整到真正的距离测量结果。
19、按照权利要求2所述的器械位置测定装置,其中发射元件是装在插入人体内的导管端部的一个线圈。
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CN90103075A Pending CN1049288A (zh) | 1989-05-24 | 1990-05-24 | 医疗器械的定位装置 |
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Also Published As
Publication number | Publication date |
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US5099845A (en) | 1992-03-31 |
EP0399536A1 (en) | 1990-11-28 |
CN1049287A (zh) | 1991-02-20 |
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