CN103037762B - 用于与针插入引导系统一起使用的装置 - Google Patents

用于与针插入引导系统一起使用的装置 Download PDF

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CN103037762B
CN103037762B CN201180037068.1A CN201180037068A CN103037762B CN 103037762 B CN103037762 B CN 103037762B CN 201180037068 A CN201180037068 A CN 201180037068A CN 103037762 B CN103037762 B CN 103037762B
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sensor
magnetic
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probe
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CN103037762A (zh
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J·B·考克斯
J·Z·杰霍
R·N·格尔登
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CR Bard Inc
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • 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
    • 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
    • A61B34/25—User interfaces for surgical systems
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound
    • 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
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    • A61B2034/2051—Electromagnetic tracking systems
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    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
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    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
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    • A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
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Abstract

公开了一种用于辅助针插入到患者身体中的引导系统。所述引导系统使用超声成像或者其他适合的成像技术。在一个实施方案中，引导系统包括成像设备，所述成像设备包括探测器，用于产生内部身体部分目标(例如脉管)的图像。一个或更多个传感器与所述探测器一起被包括。传感器感测与所述针相关的可检测特征，例如与所述针一起被包括的磁体的磁场。系统包括处理器，所述处理器使用与感测特征相关的数据，来确定所述针的3?D位置。系统包括显示器，用于描绘所述针的位置。所述针可以包括围绕所述针套管设置的环状磁体，或者具有磁元件和应变计来检测所述针远侧末端的可移除的探针。

Description

用于与针插入引导系统一起使用的装置
相关申请的交叉引用：本申请是一并递交的且题为“用于针和医疗部件的插入引导系统(Insertion Guidance System for Needles and Medical Components)”的美国专利申请No.13/118,033的部分继续申请，该美国专利申请No.13/118,033是递交于2008年11月25日、题为“用于导管的血管内放置的集成系统(Integrated System forIntravascular Placement of a Catheter)”的美国专利申请No.12/323,273的部分继续申请。本申请还要求2010年5月28日递交的、题为“针插入引导系统(Needle InsertionGuidance System)”的美国临时专利申请No.61/349,771的优先权。前述申请中的每个通过引用被整体并入本文。
发明内容
简要概述，本发明的实施方案涉及集成导管放置系统，所述系统被配置来在患者的脉管系统中准确地放置导管。所述集成系统采用至少两种形式来改善导管放置的准确性：1)用于将导管导入患者的脉管系统的超声辅助引导；以及2)末端定位系统(“TLS”)，或在导管通过脉管系统的推进过程中对导管末端的基于磁方式的(例如永久磁体或电磁体)追踪，以在这样的推进过程中检测并便利对任何末端错位的纠正。
在一个实施方案中，集成系统包括具有控制处理器的系统控制台，用于临时放置在患者的身体的一部分上的末端定位传感器，以及超声探测器。所述末端定位传感器在导管被设置在脉管系统中时感测设置在导管内腔中的探针的磁场。在导管导入脉管系统之前，超声探测器以超声方式成像脉管系统的一部分。此外，超声探测器包括使用者输入控制装置，所述使用者输入控制装置用于控制在超声模式中的超声探测器的使用以及在末端定位模式中的末端定位传感器的使用。
在另一实施方案中，第三种方式，即，基于ECG信号的导管末端引导被包括在所述系统中，以使能导管末端的引导至一相对于产生ECG信号的患者的心脏结(a node of thepatient′s heart)的期望位置。
此外，本公开的实施方案还涉及用于辅助针或其他医疗部件插入到患者身体中的引导系统。该引导系统使用超声成像或者其他适合的成像技术。
在一个实施方案中，引导系统包括成像设备，所述成像设备包括探测器，用于产生内部身体部分目标(例如，举例说明，皮下脉管)的图像。与所述探测器一起被包括的一个或者更多个传感器。传感器感测与所述针相关的可检测特征，例如与所述针一起被包括的磁体的磁场。
系统包括处理器，所述处理器使用与传感器感测的可检测特征相关的数据，来在三个空间维度上确定所述针的位置和/或定向。系统包括显示器，用于描绘所述针的位置和/或定向以及所述目标的图像。
除了基于磁体的检测之外，还公开了用于检测医疗部件的其他方式，包括基于光学和基于电磁信号的系统。
在一个实施方案中，包括一个或更多个磁元件的探针可移除地插入针，来使得通过磁元件的检侧与超声探测器一起被包括的传感器能够进行针的追踪。在一个实施方案中，传感器为围绕超声探测器的部分设置的环式传感器。在另一实施方案中，探测器可以附加地包括应变传感器，该应变传感器检测针在插入患者期间的弯曲。来自应变传感器的反馈可以被输入到系统中并且被考虑来(account for)在显示器上更准确地描绘针位置。
在又另一实施方案中，磁元件被配置为限定有孔的环状无源磁体，针的套管通过所述孔。
本发明实施方案的这些和其他特征将从下面的说明和所附的权利要求书中变得更加完整清晰，或者可以通过对由下文所阐明的本发明实施方案的实践来获悉。
附图说明
将通过参考本发明的具体的实施方案提供对本发明的更加具体的描述，所述的具体实施方案在所附的附图中被图示说明。可以理解，这些附图仅描绘本发明的典型实施方案，因而不能被认为是对本发明范围的限制。将通过使用说明书附图来以附加的特征和细节对本发明的示例性实施方案进行描述和解释，其中：
图1为根据本发明的一个示例性实施方案，描绘用于脉管系统内的导管放置的集成系统的各种元件的框图；
图2为患者和借助于图1的所述集成系统被插入患者的导管的简化视图；
图3A和3B为图1的所述集成系统的探测器的视图；
图4为如被描绘在图1的所述集成系统的显示器上的超声成像的屏幕截图；
图5为在患者脉管系统中放置导管时被用来与图1的所述系统一起使用的探针的立体视图；
图6为如被描绘在图1的所述集成系统的显示器上的图标(icon)，指示在导管末端的放置过程中图5的所述探针的远侧端的位置；
图7A-7E描绘在导管末端的放置过程中可以被描绘在图1的所述集成系统的所述显示器上的各种示例性图标；
图8A-8C为在导管末端的放置过程中被描绘在图1的所述集成系统的显示器上的图像的屏幕截图；
图9为根据本发明的另一示例性实施方案，描述用于脉管系统内的导管放置的集成系统的各种元件的框图；
图10为患者和借助于图9的所述集成系统被插入患者的导管的简化视图；
图11为在患者脉管系统中放置导管时被用来与图9的所述集成系统一起使用的探针的立体视图；
图12A-12E为图11的所述探针的各部分的各种视图；
图13A-13D为用于与图9的所述集成系统一起使用的鳍状连接器(fin connector)组件的各种视图；
图14A-14C为示出探针绳缆与鳍状连接器以及图9的所述集成系统的传感器的连接的视图；
图15为图14C所示出的所述探针绳缆、鳍状连接器以及传感器的连接的剖视图；
图16为患者的ECG迹线的简化视图；
图17为在导管末端的放置过程中被描绘在图9的所述集成系统的显示器上的图像的屏幕截图；
图18为根据一个实施方案描绘用于针和其他医疗部件的基于超声的引导系统的各要素的框图；
图19为患者和插入患者体内的导管的简化视图，示出图18的引导系统可以被用于其中的一种可能的环境；
图20为图18的引导系统的超声探测器的顶视图；
图21A为根据一个实施方案的用于与图18的引导系统一起使用的针的侧视图；
图21B为图21A的针的端视图；
图22A和图22B为被用来朝向患者身体内的脉管引导针的引导系统的超声探测器的简化视图；
图23A和图23B示出用于在引导系统的显示器上进行描绘的可能的屏幕截图，示出根据一个实施方案的针的位置和定向；
图24示出根据一个实施方案的用于将针导引至患者身体内的期望目标的方法的各阶段(stage)；
图25示出根据一个实施方案的用于附接到超声探测器和相关联的显示器的传感器阵列；
图26为根据一个实施方案的用于与图18的引导系统一起使用的针握持器枪(needle holder gun)的简化视图；
图27为根据一个实施方案的包括光学引导系统的元件的超声探测器和针的简化视图；
图28示出根据一个实施方案的图27的超声探测器和针的操作；
图29为根据一个实施方案的包括基于电磁信号的引导系统的元件的超声探测器和针的简化视图；
图30为根据另一实施方案的包括基于电磁信号的引导系统的元件的超声探测器和针的简化视图；
图31A-31D为根据一个实施方案的用于与针引导系统一起使用的针和相关联的部件的各种视图；
图32为根据一个实施方案的用于与针引导系统一起使用的针的侧视图；
图33A和33B为根据一个实施方案的用于与针引导系统一起使用的针的各种视图；
图34A-34G为根据一个实施方案的用于与针引导系统一起使用的各种形状的磁元件的视图；
图35为根据一个实施方案的针套管的远侧部分的透视图，该针套管包括设置于其中的具有磁体的(magnet-bearing)探针；
图36根据一个实施方案示出图35的针与包括环式传感器的超声探测器一起使用；
图37为根据一个实施方案的包括设置在套管上的环状磁体的针的立体视图；
图38为根据一个实施方案的包括应变计的探针的侧视图；
图39A-39B示出在弯曲压力下的图38的探针和应变计；以及
图40为根据一个实施方案的包括挠曲传感器(flex sensor)的探针的侧视图。
具体实施方式
现在将参考附图，其中相似的结构将被提供以相似的参考编号。可以理解，附图为本发明的示例性实施方案的图解的和示意的表征，并且所述附图为非限制性的，也无须按比例绘制。
为清楚起见，将理解到的是，词语“近侧的(proximal)”是指相对地更靠近使用本文要描述的设备的临床医生的方向，而词语“远侧的(distal)”是指相对地远离临床医生的方向。例如，被放置在患者体内的导管的端被认为是所述导管的远侧端，而所述导管仍保留在体外的端为所述导管的近侧端。另外，如本文(包括权利要求书)所使用的词语“包括(including)”、“具有(has)”以及“具有(having)”，应当具有同词语“包括(comprising)”相同的意思。
I.辅助的导管放置
本发明总地涉及被配置来在患者的脉管系统中准确地放置导管的导管放置系统。在一个实施方案中，所述导管放置系统采用至少两种方式来改善导管放置的准确性：1)用于将导管导入患者的脉管系统的超声辅助引导；以及2)末端定位/导引系统(“TLS”)，或在导管通过弯曲的脉管系统路径的推进过程中对导管末端的基于磁方式的追踪，以在这样的推进过程中检测并便利对任何末端错位的纠正。根据一个实施方案，本系统的超声引导和末端定位的特征是被集成到单一设备中的，以供临床医生使用来放置导管。这两种方式被集成到单一设备中简化了导管放置过程，并得到相对更快的导管放置方式。例如，所述集成导管放置系统使超声和TLS的活动能够从所述集成系统的单一的显示器上被观察到。再者，位于所述集成设备的超声探测器(所述探测器在导管放置的过程中被保持在患者的无菌区域内)上的控制装置可以被用来控制所述系统的功能，从而消除对临床医生到所述无菌区域之外以控制所述系统的需要。
在另一实施方案中，第三种方式，即，基于ECG信号的导管末端引导被包括在所述系统中，以使能导管末端的引导至一相对于产生ECG信号的患者的心脏结的期望位置。本文也将这样的基于ECG的安置辅助称为“末端确认”。
根据一个实施方案，上述这三种方式的组合使所述导管放置系统能够以一相对较高水平的准确性便利在患者的脉管系统中的导管放置，即导管的远侧末端在预先确定的且期望的位置的放置。另外，由于所述导管末端的所述基于ECG的引导，对末端的放置进行的纠正可以无需起确认作用的X射线而被确认。这又减少了患者受到X射线的潜在害处、将患者送往X射线部门和从X射线部门送回所耗费的成本和时间、昂贵而不便的导管再安置(reposition)过程等等。
首先参考描绘根据本发明的一个示例性实施方案配置的导管放置系统(“系统”)的各种部件的图1和2，所述系统一般地被标明为10。如所示的，系统10一般地包括控制台20、显示器30、探测器40以及传感器50，其中每一个均将在下面进一步详细描述。
图2示出相对患者70，在通过皮肤插入部位73将导管72放入患者脉管系统的过程中，这些部件的一般关系。图2示出导管72一般地包括留在患者外部的近侧部分74以及在放置完成后留在患者脉管系统中的远侧部分76。系统10被用来将导管72的远侧末端76A最终安置(position)在患者脉管系统中的期望位置。在一个实施方案中，对导管远侧末端76A而言，所述期望位置是临近患者的心脏，例如在上腔静脉(“SVC”)的下三分之一(1/3)部分内。当然，系统10可以被用来将所述导管远侧末端放置在其他位置。导管近侧部分74还包括毂(hub)74A，毂74A提供导管72的一个或更多个内腔与从所述毂向近侧延伸的一个或更多个延伸腿74B之间的流体连通。
控制台20的示例性实施方式被示于图8C中，然而，理解到的是，所述控制台可以采用各种形式中的一种。包括非易失性存储器(例如EEPROM)的处理器22被包括在控制台20中，用于在系统10的操作期间控制系统的功能，从而起到控制处理器的作用。与控制台20一起，还包括数字控制器/模拟界面24，并且所述数字控制器/模拟界面24同时与处理器22和其他系统部件通信，以控制探测器40、传感器50以及其他系统部件之间的接口连接(interfacing)。
系统10还包括用于与传感器50连接的端口52以及可选的部件54，包括打印机、储存介质、键盘等。在一个实施方案中所述端口为USB端口，然而其他端口类型或端口类型的组合可以被用于这一端口和本文所描述的其他接口连接。与控制台20一起，包括有电源连接装置56，以使能与外部电源供应装置58的可操作连接。也可以采用内部电池60与外部电源供应装置一起使用，或单独使用内部电池60。与所述控制台20的数字控制器/模拟界面24一起，包括有电源管理电路59，以调节电源的使用及分配。
在本实施方案中，显示器30被集成到控制台20中，并且在导管放置过程中被用来向临床医生显示信息。在另一实施方案中，所述显示器可以是与所述控制台分离的。如将了解到的，由显示器30所描述的内容根据所述导管放置系统所在的模式(US、TLS或在其他实施方案中的ECG末端确认)而变化。在一个实施方案中，控制台按钮界面32(见图1、8C)和被包括在探测器40上的按钮可以被用来直接由所述临床医生调用(call up)一期望的模式至向显示器30，以在放置过程中起到辅助作用。在一个实施方案中，例如在图17中，来自多种模式(例如TLS和ECG)的信息可以被同时显示。因而，系统控制台20的单一显示器30可以被用于在进入患者的脉管系统中时进行的超声引导，在通过脉管系统的导管推进过程中的TLS引导，以及(如在稍后的实施方案中的)相对于患者的心脏结的导管远侧末端放置的基于ECG的确认。在一个实施方案中，所述显示器30为一LCD设备。
图3A和3B根据一个实施方案描绘探测器40的特征。探测器40被用来与上面提到的所述第一方式一起使用，即，脉管(例如，静脉)的基于超声(“US”)的可视化，为导管72插入脉管系统做准备。这样的可视化为将导管导入患者的脉管系统提供实时的超声引导，并且有助于减少与这样的导入相关联的典型并发症，包括意外动脉穿孔、血肿、气胸等等。
手持探测器40包括容纳有压电阵列的头部80，当所述头部以抵住患者皮肤的方式邻近预期的插入部位73(图2)被放置时，所述压电阵列用来产生超声脉冲并接收由患者身体反射后的所述超声脉冲的反射波。探测器40还包括可以被包括在按钮板(pad)82上的多个控制按钮84。在本实施方案中，系统10的方式可以是由控制按钮84控制的，因而，排除了临床医生到所述无菌区域(是在导管放置之前围绕患者插入部位形成的)之外的需要，以经由控制台按钮界面32的使用来改变模式。
这样，在一个实施方案中，临床医生采用所述第一(US)方式来确定适当的插入部位并形成脉管进入，例如利用针或导引装置，然后利用导管。然后，所述临床医生可以经由推按探测器按钮控制板82上的按钮无缝地切换到所述第二(TLS)方式，而无需到所述无菌区域之外。然后，可以使用所述TLS模式来帮助导管72通过脉管系统朝所意图的目的地推进。
图1示出探测器40还包括按钮和存储器控制器42，用来控制按钮和探测器的操作。在一个实施方案中，按钮和存储器控制器42可以包括非易失性存储器，例如EEPROM。按钮和存储器控制器42与控制台20的探测器接口44进行可操作的通信，探测器接口44包括用于与所述探测器压电阵列接口连接的压电输入/输出部件44A，以及用于与按钮和存储器控制器42接口连接的按钮和存储器输入/输出部件44B。
图4示出当系统10在其第一超声方式时，如在显示器30上所描绘的示例性屏幕截图88。示出患者70的皮下区域的图像90，描绘静脉92的截面。由探测器40的所述压电阵列的操作生成图像90。同样被包括在显示器屏幕截图88上的是测深标尺指示器94、内腔尺寸比例96以及其他指示标记98，测深标尺指示器94提供关于在患者皮肤下图像90的深度的信息，内腔尺寸比例96提供关于相对标准导管内腔尺寸的静脉92的尺寸的信息，其他指示标记98提供关于系统10的状态或可能采取的动作的信息，例如，定格画面、图像模板、保存数据、图像打印、电源状态、图像亮度等等。
请注意，在其他实施方案中，当静脉被描绘在图像90中时，其他身体内腔或部分可以被成像。注意到的是，如果期望的话，在图4中所示出的所述US模式可以同时与其他模式(例如，所述TLS模式)一起被描绘在显示器30上。在导管放置期间，除可视的显示器30以外，系统10还可以采用听觉信息(例如，嘟嘟声、音调等等)来辅助临床医生。另外，包括在探测器40上的所述按钮和控制台按钮界面32可以以各种方式来配置，包括除了按钮以外使用例如滑动开关、切换开关、电子或触控感应式板等等的使用者输入控制装置。附加地，在系统10的使用期间，US和TLS二者的活动可以同时发生或单独发生。
如刚刚所描述的，手持超声探测器40被用来作为集成导管放置系统10的一部分，以使能患者的脉管系统外周的US可视化，为导管的经皮导入做准备。然而，在本示例性实施方案中，如下面所描述的，当在脉管系统中导引所述导管朝向其期望的目的地前进时，所述探测器还被用来控制系统10的所述TLS部分或第二方式的功能。再者，因为探测器40被用于所述患者的所述无菌区域中，这一特征使得能够完全从所述无菌区域中对TLS的功能进行控制。因而，探测器40为双重用途的设备，使能从所述无菌区域对系统10的US和TLS功能的方便控制。在一个实施方案中，如下面将进一步描述的，所述探测器还可以被用来控制与ECG相关的或导管放置系统10的第三方式的一些或全部功能。
导管放置系统10还包括上面提到的所述第二方式，即，基于磁方式的导管TLS或末端定位系统。在初始放入并通过患者70的脉管系统推进的过程中，所述TLS使临床医生能够快速定位并确认导管72的位置和/或定向，所述导管72例如为外周静脉穿刺中心静脉导管(“PICC”)、中心静脉导管(“CVC”)或其他适合的导管。具体地，所述TLS方式检测由装配有磁元件的末端定位探针激发的磁场，在一个实施方案中，所述末端定位探针被预装入被以纵向方式限定的导管72的内腔中，从而使所述临床医生能够确定在患者身体内所述导管末端的大体位置及定向。在一个实施方案中，可以使用如下的美国专利中的一种或更多种教导对所述磁组件进行追踪：5,775,332；5,879,297；6,129,668；6,216,028以及6,263,230。本文通过引用将前面提到的美国专利的全部内容并入本申请。所述TLS还显示所述导管末端所指向的方向，从而进一步辅助导管的准确放置。所述TLS进一步辅助临床医生确定所述导管末端的错位是何时发生的，例如在所述末端已经偏离所期望的静脉路径进入另一静脉的情况时。
如所提到的，所述TLS利用探针来使导管72的所述远侧端在其通过脉管系统的推进过程中能够被追踪。图5给出了这样的探针100的一实施例，探针100包括近侧端100A和远侧端100B。在探针近侧端100A包括有手柄，以及从所述手柄中向远侧延伸的芯线104。磁组件被设置在芯线104远侧。所述磁组件包括一个或更多个邻近探针远侧端100B被彼此相邻设置且由管108封装的磁元件106。在本实施方案中，包括有多个磁元件106，每一个元件包括与其他磁元件以端对端的方式堆叠的固体圆柱状铁磁体。粘合剂末端110可以在磁元件106远侧塞堵管108的所述远侧末端。
请注意的是，在其他实施方案中，所述磁元件不仅仅在形状方面，在组成、数目、尺寸、磁性类型以及在所述探针远侧段中的位置等方面的设计上也可以变化。例如，在一个实施方案中，所述多个铁磁元件由电磁组件替代，例如产生用于由所述传感器检测的磁场的电磁线圈。在此可用的组件的另一实施例可以从题目为“医疗器械定位装置(MedicalInstrument Location Means)”的美国专利No.5,099,845中得到，本文通过引用将其全部内容并入本申请。此外，包括可以与所述TSL方式一起使用的磁元件的探针的其他实施例可以在2006年8月23日提交的题目为“探针仪器及制造方法(Stylet Apparatuses andMethods of Manufacture)”的美国申请No.11/466,602中得到，本文通过引用将其全部内容并入本申请。因此，本发明的实施方案意图包括这些和其他变体。在此应当理解的是，如本文所使用的“探针(stylet)”可以包括被配置来在所述导管的内腔中以可移除的方式放置以帮助将所述导管的远侧端放置在患者的脉管系统中期望位置的各种设备中的任一种。
图2示出探针100的设置情况，探针100基本上是在导管72的内腔中，以致探针100的所述近侧部分从所述导管内腔向近侧延伸，通过毂74A并通过延伸腿74B中选定的一个伸出。这样设置在所述导管内腔中，探针100的远侧端100B与远侧导管端76A基本上是共端头的，以致由所述探针远侧端的所述TLS所进行的相对应的检测指示所述导管远侧端的位置。
在TLS操作期间，系统10采用TLS传感器50以检测由探针100的磁元件106产生的磁场。如图2中所示的，在导管插入期间，TLS传感器50被放置在患者的胸部。将TlS传感器50放置在患者胸部的预先确定的位置(如通过使用外部身体标志(landmark))，以使能如上面所描述的被设置在导管72中的探针磁元件106的磁场，来使其在导管通行经过患者脉管系统期间被检测到。再者，因为探针磁组件的磁元件106与导管72的远侧端76A(图2)是共端头的，由TLS传感器50所进行的所述磁元件的磁场的检测向临床医生提供关于所述导管远侧端在其通行期间的位置和定向的信息。
更具体地，如图1所示的，TLS传感器50经由端口52中的一个或更多个可操作地连接到系统10的控制台20。请注意的是，在所述TLS传感器和所述系统控制台之间还可以使用其他连接方案而不受限制。正如所描述的，磁元件106被用在探针100中以使导管远侧端76A(图2)相对被放置在患者的胸部的TLS传感器50的位置能够是可观察到的。在TLS模式期间，由TLS传感器50所进行的探针磁元件106的检测以图形化的方式被显示在控制台20的显示器30上。以这种方式，放置所述导管的临床医生能够大体确定在患者脉管系统中导管远侧端76A相对TLS传感器50的位置，并且检测导管错位(例如，所述导管沿非期望的静脉所进行的推进)是何时发生的。
图6和7A-7E示出图标的实施例，所述图标可以被控制台显示器30使用以描绘由TLS传感器50所进行的探针磁元件106检测。特殊地，图6示出当所述磁元件被安置在所述TLS传感器下方时，描绘探针100的所述远侧部分(包括如被TLS传感器50所检测的磁元件106)的图标114。因为探针远侧端100B与导管72的远侧端76A基本上是共端头的，所述图标指示所述导管远侧端的位置和定向。图7A-7E示出当探针100的磁元件106没有被安置在TLS传感器50的正下方(但在仍能被检测到的附近)时，可以被描绘在控制台显示器30上的各种图标。所述图标可以包括根据所述探针磁组件的位置(即，在本实施方案中，磁元件106相对TLS传感器50的位置)而被显示的半图标114A和四分之一图标114B。
图8A-8C描绘在TLS模式中取自系统10的显示器30的屏幕截图，示出探针100的所述磁组件是如何被描述的。图8A的屏幕截图118示出TLS传感器50的表征性图像120。被提供在显示器屏幕截图118上的其他信息包括测深标尺指示器124、状态/动作指示标记126以及与被包括在控制台20上的按钮界面32(图8C)相对应的图标128。尽管在本实施方案中，图标128是简单的指示器以引导使用者辨识按钮界面32相对应的按钮的用途，在另一实施方案中，所述显示器可以被制成触控感应式的，从而所述图标自身可以起到按钮界面的作用并且可以根据所述系统所在的模式而改变。
在插入患者的脉管系统后导管通过脉管系统推进的初始阶段期间，与探针远侧端100B基本上具有共端头的导管72的远侧端76A是相对距TLS传感器50较远的。这样，所述显示器屏幕截图将提示“无信号”，指示来自所述探针磁组件的磁场未被检测到。在图8B中，邻近探针远侧端100B的所述磁组件，尽管其没有在所述传感器的正下方，已经推进到足够接近TLS传感器50而能被检测到。这由被示出在传感器图像120的左侧的半图标114A所指示，表征所述探针的磁组件从患者的视角来看是被安置在TLS传感器50的右侧的。
在图8C中，邻近探针远侧端100B的所述磁组件已经在TLS传感器50的下方推进，以致其相对的位置和定向能被所述TLS传感器检测到。这由在传感器图像120上的图标114指示。请注意的是，按钮图标128提供可以通过按压控制台按钮界面32中相对应的按钮来实现的动作的提示。这样，按钮图标128可以根据系统10所在的方式而改变，从而为按钮界面32提供使用上的灵活性。请进一步注意的是，因为探测器40的按钮控制板82(图3A、3B)包括可以模仿按钮界面32中的多个按钮的按钮84，在保持于所述无菌区域中的同时，显示器30上的按钮图标128向临床医生提供引导以利用探测器按钮84控制系统10。例如，如果临床医生需要离开TLS模式并返回US(超声)模式，在探测器按钮控制板82上的适当控制按钮84可以被按压，并且所述US模式可以立即被调用，同时显示器30刷新到适应US功能所需的所述可视信息，如图4中所示。这无需临床医生到所述无菌区域之外即可实现。
现在参考图9和10，根据另一示例性实施方案描述集成导管放置系统10。同上，如上面所描述的，集成系统10包括控制台20、显示器30，用于US功能的探测器40，以及用于末端定位功能的TLS传感器50。请注意的是，图9和10中所描绘的系统10在诸多方面与图1和2所示的系统是相似的。由此，下面仅对选出的不同之处进行讨论。图9和10的系统10包括附加的功能，其中导管远侧末端76A相对窦房(“SA”)或患者70的心脏的其他电脉冲发出结的接近度的确定可以被确认，从而提供增强的能力来准确地将所述导管远侧末端放置在邻近所述结的期望位置。另外，本文称之为“ECG”或“基于ECG的末端确认”，系统10的这一第三方式使能来自所述SA结的ECG信号的检测，以将所述导管远侧末端放置在所述患者脉管系统中期望位置。请注意的是，所述US、TLS以及ECG方式在本系统10中被无缝地组合，并且可以被一同使用或单独使用来帮助放置导管。
图9和10示出根据本实施方案另外被配置有探针130的系统10。就整体而言，导管探针130被以可移除的方式预先设置在经由插入部位73被插入到患者70的导管72的所述内腔中。探针130，除了包括用于基于磁方式的TLS方式的磁组件之外，包括邻近其远侧端的ECG传感器组件，并且包括与所述导管末端的所述远侧端共端头的一部分，用于感测由所述SA结产生的ECG信号。与先前的实施方案相比之下，探针130包括从其近侧端延伸的绳缆134，绳缆134可操作地连接到TLS传感器50。如将被进一步以细节描述的，在作为所述基于ECG信号的末端确认方式的一部分的所述导管末端位置的确认过程中，探针绳缆134允许由被包括在探针130的远侧部分上的所述ECG传感器组件所检测到的ECG信号被传送到TLS传感器50。参考和接地ECG引线/电极对158附接到患者70的身体，并且被可操作地附接到TLS传感器50以使能所述系统来滤掉与心脏的SA结的电活动无关的高电平电活动，从而使能所述基于ECG的末端确认功能。接收自被放置在患者皮肤上的ECG引线/电极对158的参考信号和接地信号，与由所述探针ECG传感器组件感测的所述ECG信号一起被安置在患者胸部的TLS传感器50(图10)。如将要描述的，TLS传感器50和/或控制台处理器22可以处理所述ECG信号数据以在显示器30上产生心电图波形。在TLS传感器50处理所述ECG信号数据的情况下，处理器被包括在其中以实现意图的功能。如果控制台20处理所述ECG信号数据，处理器22、控制器24或其他处理器可以在所述控制台中被应用，以处理所述数据。
因此，随着其推进通过患者脉管系统，如上面所描述的，装配有探针130的导管72可以在安置在患者的胸部上的TLS传感器50(如图10所示)下推进。这使TLS传感器50能够检测探针130的所述磁组件的位置，探针130的所述磁组件与定位在患者的脉管系统中的所述导管的远侧末端76A基本上是共端头的。在ECG模式期间，由TLS传感器50进行的所述探针磁组件的检测被描绘在显示器30上。在ECG模式期间，显示器30还描绘由探针130的所述ECG传感器组件所检测到的患者心脏电活动的结果所产生的ECG心电图波形。更具体地，包括P-波波形的所述SA结的所述ECG电活动由所述探针的所述ECG传感器组件(下面描述)检测，并且被传送至TLS传感器50和控制台20。然后，所述ECG电活动被处理以在显示器30上进行描述。随后，放置所述导管的临床医生可以观察所述ECG数据来确定导管72的远侧末端76A的最佳放置，例如在一个实施方案中是邻近所述SA结。在一个实施方案中，控制台20包括接收并处理由所述探针ECG传感器组件所检测的所述信号的必要的电子部件(例如处理器22(图9))。在另一实施方案中，TLS传感器50可以包括处理所述ECG信号的必要的电子部件。
如已经讨论过的，在所述导管的放置过程中，显示器30被用来向临床医生显示信息。显示器30的内容根据所述导管放置系统所在的模式(US、TLS或ECG)而改变。临床医生可以立即调用这三种模式中的任一种到显示器30，并且在一些情况下，来自多种模式(例如TLS和ECG)的信息可以同时被显示。在一个实施方案中，和前面一样的，所述系统所在的模式可以由包括在手持探测器40上的控制按钮84控制，从而排除了临床医生到所述无菌区域之外(例如，触控控制台20的按钮界面32)以改变模式的需要。因而，在本实施方案中，探测器40还被用来控制系统10的与ECG相关的一些或全部功能。请注意的是，按钮界面32或其他输入结构也可以被用来控制系统功能。同样，在导管放置期间，除了使用可视的显示器30以外，所述系统还可以采用听觉信息(例如，嘟嘟声、音调等等)来辅助临床医生。
现在参考图11-12E，描述探针130的一个实施方案的各种细节，探针130以可移除的方式被装入导管72中并且在插入期间被用来将所述导管的远侧末端76A安置在患者脉管系统中的期望位置。如所示出的，当从所述导管移出时，探针130限定近侧端130A和远侧端130B。连接器132被包括在近侧探针端130A，并且绳缆134从所述连接器向远侧延伸并附接到手柄136。芯线138从手柄136向远侧延伸。在一个实施方案中，探针130被预装入导管72的内腔中，以致远侧端130B在所述导管远侧端76A处(图10)与所述导管开口基本上是齐平或共端头的，并且以致芯线138的近侧部分、手柄136以及绳缆134从延伸管74B中选定的一个向近侧延伸。注意到的是，尽管本文以探针进行描述，在其他实施方案中，导丝或其他导管引导器械可以被包括在本文所描述的实施方案的原理中。
芯线138限定细长的形状并且是由适合的探针材料构成，包括不锈钢或记忆材料，例如在一个实施方案中的包含镍和钛的合金(通常公知的缩写为镍钛诺(“nitinol”))。尽管未在本文中示出，在一个实施方案中，芯线138由镍钛诺来制造使所述芯线与所述探针的远侧段相对应的所述部分能够具有预成形的弯曲结构，从而促使导管72的所述远侧部分形成相似的弯曲结构。在其他实施方案中，所述芯线不包含预成形。进一步地，所述镍钛诺结构增强芯线138的扭转能力，以使当被设置在导管72的所述内腔中时探针130的远侧段能够被操控，这又使所述导管的所述远侧部分在导管插入期间能够被导引通过脉管系统。
提供手柄136来使能所述探针对导管72的插入/移除。在探针芯线138是可扭转的实施方案中，手柄136进一步使所述芯线在导管72的所述内腔中能够被旋转，以帮助导引所述导管远侧部分通过患者70的脉管系统。
手柄136附接到绳缆134的远侧端。在本实施方案中，绳缆134是具有弹性、受屏蔽的线缆，绳缆134包容一条或更多条电气连接到芯线138(起到上面所涉及的所述ECG传感器组件的作用)以及绳缆连接器132的导线。这样，绳缆134提供从芯线138的所述远侧部分通过绳缆连接器132至探针130的近侧端130A的导电通路。如将要解释的，绳缆连接器132被配置来可操作地连接到在患者胸部上的TLS传感器50，用来帮助将导管远侧末端76A导引至患者脉管系统中的期望位置。
如在图12B-12D所见的，芯线138的远侧部分从接合点142向远侧是逐渐变细的或在直径上是减少的。套管140在所述减少直径的芯线部分上滑动。尽管在此具有相对较大的直径，在另一实施方案中，所述套管可以被选择尺寸来基本上匹配所述探针芯线的所述近侧部分的直径。探针130还包括被邻近其远侧端130B设置的用于在TLS模式期间使用的磁组件。在所述图示说明的实施方案中，所述磁组件包括被设置在减少直径的芯线138的外表面和套管140邻近探针远侧端130B的内表面之间的多个磁元件144。在本实施方案中，磁组件144包括20个固体圆柱状的以类似于图2的探针100的方式被端对端地堆叠的铁磁体。然而，在其他实施方案中，所述磁元件可以不仅仅在形状方面，而且在组成、数目、尺寸、磁性类型以及在所述探针中的位置等方面的设计上也可以变化。例如，在一个实施方案中，所述磁组件的所述多个磁体由产生用于由所述TLS传感器检测的磁场的电磁线圈替代。因此，本发明的实施方案意图包括这些和其他变体。
磁元件144被用于探针130的远侧部分中以使探针远侧端130B相对被放置在患者胸部上的TLS传感器50的位置能够是可观察到的。如已经提及的，随着具有所述探针的导管72推进通过患者脉管系统，TLS传感器50被配置来检测磁元件144的磁场。以这种方式，放置导管72的临床医生能够大体确定导管远侧端76A在患者脉管系统中的位置并且检测导管错位(例如，所述导管沿非期望的静脉的推进)是何时发生的。
根据一个实施方案，探针130还包括前面提到的ECG传感器组件。在插入期间，所述ECG传感器组件使设置在导管72的内腔中的探针130能够被用来检测由SA或其他患者心脏结所产生的心房内ECG信号，由此允许将导管72的远侧末端76A导引至在脉管系统中邻近患者心脏的预先确定的位置。因此，所述ECG传感器组件在确认导管远侧末端76A的合适放置位置中起辅助作用。
在图11-12E中所图示说明的实施方案中，所述ECG传感器组件包括邻近探针远侧端130B设置的芯线138的远侧部分。芯线138是具有导电性的，使ECG信号能够被其所述远侧端检测并且能够被沿所述芯线向近侧传输。导电材料146(例如，导电性环氧树脂)填充邻近芯线138的所述远侧终端的套管140远侧部分，从而与所述芯线的所述远侧端是以导电方式连通的。这又增加了探针130的远侧端130B的所述导电表面，从而改善了其检测ECG信号的能力。
在放置导管之前，探针130被装入导管72的内腔中。请注意的是，可以由制造商将探针130预装入所述导管内腔，或在插入导管之前由临床医生装入所述导管。探针130被放置在所述导管内腔中，以致探针130的远侧端130B与导管72的远侧末端76A基本上是共端头的，从而使所述探针和所述导管二者的所述远侧末端基本上是彼此对齐放置的。如已经描述过的，导管72和探针130的所述共端头使所述磁组件能够在TLS模式中与TLS传感器50一起起到这样的作用，即随着导管远侧末端76A在患者脉管系统中所进行的推进来追踪其位置。然而，请注意的是，就系统10的所述末端确认功能而言，探针130的远侧端130B无需与导管远侧端76A共端头。相反，所需的仅是在脉管系统和所述ECG传感器组件之间的导电路径，在这种情况下就是芯线138，以致所述SA结或其他患者心脏结的电脉冲可以被检测到。在一个实施方案中，这一导电路径可以包括各种成分，包括，盐溶液、血液等等。
在一个实施方案中，一旦导管72已经经由插入部位73(图10)被导入患者脉管系统，可以采用如已经描述过的系统10的所述TLS模式来朝向导管远侧末端76A邻近所述SA结的所意图的目的地推进导管远侧末端76A。靠近心脏区域后，系统10可以被切换到ECG模式以使由所述SA结发出的ECG信号能够被检测到。随着所述装有探针的导管朝向患者的心脏被推进，包括芯线138的所述远侧端和导电材料146的所述导电性ECG传感器组件开始检测由所述SA结所产生的电脉冲。这样，所述ECG传感器组件起到检测所述ECG信号的电极的作用。邻近所述芯线远侧端的细长的芯线138作为导电通路来将由所述SA结所产生的且由所述ECG传感器组件所接收到的电脉冲传送到绳缆134。
绳缆134将所述ECG信号传递到被临时放置在患者胸部上的TLS传感器50。绳缆134被可操作地经由绳缆连接器132或其他适合的直接或间接的起连接作用的结构连接到TLS传感器50。如所描述的，然后所述ECG信号可以被处理并且被描绘在系统显示器30上(图9、10)。对由TLS传感器50接收并由显示器30显示的所述ECG信号进行的监控，使临床医生能够随着导管远侧末端76A朝向所述SA结的推进，观察并分析在所述信号中发生的变化。当所接收到的ECG信号匹配一期望的轮廓(profile)时，临床医生可以确定导管远侧末端76A已到达一相对于所述SA结的期望位置。如所提到的，在一个实施方案中，这一期望位置位于所述SVC的下三分之一(1/3)部分内。
所述ECG传感器组件以及磁组件可以合作来辅助临床医生在脉管系统中放置导管。一般地，探针130的所述磁组件在从初始的导管插入开始的总的脉管系统引导中辅助临床医生，以将导管72的远侧端76A放置在患者心脏的总的区域内。然后，随着所述探针ECG传感器组件靠近所述SA结，通过使临床医生能够观察到由心脏所产生的所述ECG信号中所发生的变化，所述ECG传感器组件可以被用来在所述SVC中将导管远侧端76A引导至期望位置。再有，一旦观察到适合的ECG信号轮廓，临床医生可以确定探针130和导管72二者的远侧端已经抵达相对于患者心脏的所述期望位置。一旦导管72已经如所期望地被安置，导管72可以被固定在适当位置，并且探针130从所述导管内腔移除。在此，请注意的是，所述探针可以包括除文本已经明确描述过的以外的各种结构中的一种。在一个实施方案中，所述探针可以被直接地附接到所述控制台而不是间接地经由所述TLS传感器进行附接。在另一实施方案中，使能其TLS和与ECG相关的功能的探针130的结构可以被集成到所述导管结构自身中。例如，在一个实施方案中，所述磁组件和/或ECG传感器组件可以被并入所述导管的壁。
图13A-15根据本实施方案，描述关于从探针绳缆134到被安置在患者胸部上的TLS传感器50的ECG信号数据通路的各种细节。具体地，这一实施方案涉及自围绕导管72和插入部位73的无菌区域的ECG信号数据的通路(包括探针130和绳缆134)，以及非无菌区域，例如其上被安置有所述TLS传感器的患者胸部。这样的通路应当不会破坏所述无菌区域而使其无菌性受损害。在所述导管的插入过程中被安置在患者70上的无菌布单限定所述无菌区域的大部分：在所述布单之上的区域是无菌的，而在其下方的(不包括所述插入部位和紧紧围绕的区域)是非无菌的。如将可见的，下面所进行的讨论包括与探针130相关联的至少一第一连通节点，以及与TLS传感器50相关联的第二连通节点，彼此可操作地进行连接以使ECG信号数据能够在二者间传输。
图13A-15中所描绘的是这样的一个实施方案，即解决从所述无菌区域到所述非无菌区域而不影响前者无菌性的ECG信号数据的通路问题，描绘“穿过布单(through-drape)”的实施方式，也被称为“鲨鱼鳍(shark fin)”的实现方式。具体地，如上面所描述的，图14A示出在导管的插入过程中用于放置在患者胸部上的TLS传感器50。TLS传感器50包括在其顶部表面的限定凹槽152A的连接器底部152，在凹槽152A中设置有三个电气底部触头154。同样在图13A-13D中示出的鳍状连接器156被选择尺寸，来如图14B和15中所示出的以滑动的方式被连接器底部152的凹槽152A所接纳。两个ECG引线/电极对158从鳍状连接器156延伸，用于放置在肩部和躯干或患者身体上的其他适合的外部位置。布单-穿过绳缆连接器132被配置来以滑动的方式配接鳍状连接器156的一部分，以实现如将在下面进一步描述的从探针120通过所述无菌区域到TLS传感器50的导电通路。
图13A-13D示出鳍状连接器156的其他各方面。具体地，鳍状连接器156限定被选择尺寸来被连接器底部152的凹槽152A接纳(图14B、15)的下筒形部分160。由中心锥面164所围绕的孔162被包括在上筒形部分166的后端上。上筒形部分166被选择尺寸来接纳探针130的绳缆连接器132(图14C、15)，以致延伸进入绳缆连接器132的凹槽172(图15)的针触头170被所述中心孔引导，直到其就位于鳍状连接器156的孔162中，从而使所述绳缆连接器与所述鳍状连接器互相连接。接合件(如在图13C和13D中所示出的接合件169)可以被包括在鳍状连接器156上，以与在绳缆连接器132上的相对应构件接合，来帮助保持在这两个部件之间的配接(mating)。
图13D示出鳍状连接器156包括多个电气触头168。在本实施方案中，三个触头168以这样的形式被包括：两个最前面的触头的每一个电气连接ECG引线158中的一条的终端，并且后面的触头延伸进入孔162的轴向邻近区域，从而当绳缆连接器132的针触头170配接鳍状连接器156时(图15)，电气连接绳缆连接器132的针触头170。鳍状连接器156的每一个触头168的底部分被安置来电气连接TLS传感器连接器底部152的底部触头154中相对应的一个。
图14B示出第一连接阶段，其中通过所述鳍状连接器的下筒形部分160与连接器底部凹槽152A的滑动接合，使鳍状连接器156以可移除的方式配接TLS传感器连接器底部152。这一接合使连接器底部触头154和相对应的鳍状触头168电气连接。
图14C示出第二连接阶段，其中通过绳缆连接器凹槽172与所述鳍状连接器的上筒形部分166之间的滑动接合，使绳缆连接器132以可移除的方式配接鳍状连接器156。如在图15中最佳可见的，这一接合使绳缆连接器针触头170和鳍状连接器156的后触头168电气连接。在本实施方案中，绳缆连接器132相对于鳍状连接器156的水平滑动运动与当所述鳍状连接器被以可滑动的方式配接到所述传感器连接器底部凹槽152A时(图14B)的滑动运动是在相同的接合方向上。在一个实施方案中，探针130/绳缆连接器132中的一个或两个以及鳍状连接器156是一次性的。同样，在一个实施方案中，所述绳缆连接器在所述鳍状连接器已经被配接到所述TLS传感器之后，可以被配接到所述鳍状连接器，而在另一实施方案中，所述绳缆连接器可以在所述鳍状连接器被配接到所述TLS传感器之前，先通过外科手术布单被配接到所述鳍状连接器。
在图14C所示的连接方案中，探针130经由绳缆连接器132被可操作地连接到TLS传感器150，因而使所述探针的所述ECG传感器组件能够将ECG信号传送到所述TLS传感器。另外，ECG引线/电极对158被可操作地连接到TLS传感器50。然而，在一个实施方案中，绳缆连接器132被称为用于探针130的第一连通节点，而鳍状连接器156被称为用于TLS传感器50的第二连通节点。
请注意的是，各种其他起到连接作用的方案和结构可以被用来在所述探针和所述TLS传感器之间实现可操作的连通。例如，所述绳缆连接器可以使用片触头而不是针触头来刺穿所述布单。或者，所述鳍状连接器可以是与所述TLS传感器一体地形成的。因此，这些和其他结构被包含在本发明的实施方案的范围内。
如在图15中所见的，在导管的放置期间被用来形成无菌区域的无菌布单174被放置在绳缆连接器132和鳍状连接器156的相互连接之间。正如所描述的，绳缆连接器132包括被配置来在所述两个部件相配接的时候刺穿布单174的针触头170。这样的刺穿在由针触头170占据的无菌布单174中形成小洞或穿孔175，从而将由所述针触头形成的所述布单穿孔的尺寸最小化。另外，绳缆连接器132和鳍状连接器156之间的配合是这样的，以致在无菌布单中由针触头170的穿过形成的所述穿孔由绳缆连接器凹槽172包围，因而保持所述布单的所述无菌性并且防止所述布单中的裂口可能损害由此形成的所述无菌区域。绳缆连接器凹槽172被这样配置，以在被针触头170刺穿之前将无菌布单174向下折，以致所述针触头在被设置为邻近鳍状连接器156的孔162之前不会刺穿所述布单。在此，请注意的是，绳缆连接器132和鳍状连接器156被这样配置，以便利其间通过不透明的无菌布单174的以不可见的方式的(blindly)对准，即，经由临床医生在不可见的情况下对两个部件所进行的触摸检查。
请进一步注意的是，如在图15中所示的鳍状连接器156的鳍状触头168被配置来以这样的方式配接传感器底部触头154，即帮助保持所述鳍状连接器与传感器底部凹槽152A的接合。这又减少对将鳍状连接器156固定到TLS传感器50的附加器械的需求。
图16示出典型ECG波形176，包括P-波和QRS波群。一般地，所述P-波的幅度根据所述ECG传感器组件离产生波形176的所述SA结的距离而变化。临床医生可以在确定所述导管末端何时被恰当地邻近心脏安置时使用这一关系。例如，在一个实施方式中，如已经讨论过的，所述导管末端以期望的方式被放置在所述上腔静脉的下三分之一(1/3)内。由探针130的所述ECG传感器组件所检测的所述ECG数据被用来再现波形(例如，波形176)，用于在ECG模式期间在系统10的显示器30上进行描述。
现在参考图17，根据一个实施方案，描述当系统10在ECG模式(将在下面进一步描述的所述第三方式)中时，在显示器30上所显示的ECG信号数据的各方面。显示器30的屏幕截图178包括所述TLS方式的多个要素，包括TLS传感器50的表征图像120，并且可以具有在通行穿过患者脉管系统期间对应于探针130的所述远侧端的位置的图标114。屏幕截图178还包括窗口180，由探针130的所述ECG传感器组件捕获并由系统10处理的当前ECG波形被显示在窗口180中。随着新波形被检测到，窗口180不断地被刷新。
窗口182包括对最新被检测到的ECG波形所进行的连续描绘，并且包括刷新条182A，随着所述波形被检测到，刷新条182A横向地移动以刷新所述波形。窗口184A被用来显示在所述ECG传感器组件被放到所述SA结的邻近范围之内以前所捕获到的基线ECG波形，用于比较的用途以帮助临床医生确定是何时抵达的所述期望的导管末端位置。当使用者按压在探测器40或控制台按钮界面32上的预先确定的按钮时，窗口184B和184C可以呈现由使用者所选出的检测到的ECG波形。在窗口184B和184C中的所述波形被保留直到由使用者经由按压按钮或利用其他输入装置所进行的选择而引发的新波形所覆盖。如在先前的模式中，测深标尺124、状态/动作指示标记126以及按钮图标128被包括在显示器30上。完整性指示器186也被包括在显示器30上，来给出所述ECG引线/电极对158是否被可操作地连接到TLS传感器50的提示。
因而，如上面所见的，在一个实施方案中显示器30在单一屏幕上同时描绘所述TLS方式和ECG方式二者的各要素，从而为临床医生提供丰富的数据以帮助将所述导管远侧末端放置在期望位置。请进一步注意的是，在一个实施方案中，所述屏幕截图的打印输出或所选出的ECG或TLS数据可以被保存、打印，或者由系统10保留以使能恰当的导管放置的文件记录。
尽管本文所描述的实施方案涉及特别结构的导管，例如PICC或CVC，这样的实施方案仅仅为示例性的。因此，本发明的原理可以被扩展到大量不同结构和设计的导管。
II.对针/医疗部件的辅助引导
本文所描述的本发明的实施方案一般地涉及这样的引导系统，该引导系统用于在基于超声或其他适合的过程期间定位和引导针或其他医疗部件来例如利用针进入患者的皮下脉管。在一个实施方案中，引导系统使得针的位置、定向和推进能够在脉管的超声图像之上被实时叠置，由此使得临床医生能够准确地将针引导至意图的目标。此外，在一个实施方案中，引导系统以五个自由度追踪针的位置：x、y和z空间坐标空间、针俯仰(pitch)以及针偏向(yaw)。这样的追踪使得针能够以相对高的准确度被引导和放置。
首先参考图18和19，图18和19描绘根据本发明的一个实施方案配置的基于超声的针引导系统(“系统”)的各部件，所述系统总地被表示为1110。如所示的，系统1110一般地包括超声(“US”)成像部分，该超声成像部分包括控制台1120、显示器1130以及探测器1140，其中每一个均在下面进一步详细描述。注意的是，在一个实施方案中，就某些部件来说，系统1110与图1中示出的系统10是相似的。然而，应当注意的是，超声成像部分可以以本文所示出和描述的内容以外的各种各样的方式中的一种来配置。
系统1110的超声成像部分被用来在针或其他设备的经皮插入以进入目标之前对患者身体的目标内部部分进行成像。如下面所描述的，在一个实施方案中，在导管随后插入到患者的脉管系统的静脉或其他部分之前进行针的插入。然而，理解的是，针插入患者身体可以出于各种各样的医疗目的来进行。
图19根据一个实施方案示出相对患者1170，在通过皮肤插入部位1173将导管1172最终放置到患者脉管系统中的过程期间，上面所描述的部件的一般关系。图19示出导管1172一般地包括在放置完成后保留在患者外部的近侧部分1174以及留在患者脉管系统中的远侧部分1176。系统1110被用来将导管1172的远侧末端1176A最终安置在患者脉管系统中的期望位置。在一个实施方案中，导管远侧末端1176A的期望位置邻近患者的心脏，例如在上腔静脉(“SVC”)的下三分之一(1/3)部分内。当然，系统1110可以被用来将所述导管远侧末端放置在其他位置上。
导管近侧部分1174还包括毂1174A，毂1174A提供导管1172的一个或更多个内腔与从所述毂向近侧延伸的一个或更多个延伸腿1174B之间的流体连通。如所述的，针在插入部位1173放入患者脉管系统通常是在导管的插入之前进行的，然而理解的是，可以采用其他的放置方法。此外，理解的是，上面的论述仅仅是使用系统1110的一个实施例；事实上，系统1110可以被用于各种各样的用途，例如在如上所述的导管插入之前的针的放置、用于其他用途的针的插入或者用于其他医疗部件插入患者身体，包括X射线或超声标记、活检护套、切除部件、膀胱扫描部件、腔静脉滤器等。
更具体地，控制台1120容纳系统1110的多种部件，并且理解的是，控制台可以采用各种各样的形式中的一种。包括非易失性存储器(例如，举例说明，EEPROM)的处理器1122被包括在控制台1120中，用于在系统1110的操作期间控制系统功能并且执行各种算法，从而起到控制处理器的作用。与控制台1120一起被包括的还有数字控制器/模拟界面1124，并且所述数字控制器/模拟界面1124既与处理器1122通信又与其他系统部件通信，以控制探测器1140和其他系统部件之间的接口连接。
系统1110还包括用于与附加部件(例如可选的部件1154，包括打印机、储存介质、键盘等)连接的端口1152。在一个实施方案中，所述端口为USB端口，然而其他端口类型或端口类型的组合可以被用于这一端口和本文所描述的其他接口连接。电源连接装置1156与控制台1120一起被包括，来使能与外部电源供应装置1158的可操作连接。还可以与外部电源供应装置一起使用或单独使用内部电池1160。电源管理电路1159与所述控制台的数字控制器/模拟界面1124一起被包括，以调节电源的使用及分配。
在本实施方案中，显示器1130被集成到控制台1120中，并且在放置过程期间被用来向临床医生显示信息，例如由探测器1140获取的目标内部身体部分的超声图像。在另一实施方案中，所述显示器可以是与所述控制台分离的。在一个实施方案中，控制台按钮界面1132和被包括在探测器1140上的控制按钮1184(图19)可以被用来直接由所述临床医生调用一期望的模式至显示器1130，以在放置过程期间进行辅助。在一个实施方案中，所述显示器1130为一LCD设备。
图19进一步描绘了这样的针1200，该针1200被用来进行通过插入部位1173对患者脉管系统的初始进入。如下面将进一步详细描述的，针1200被配置来与系统1110配合而使得系统能够在基于超声的放置过程期间检测针的位置、定向和推进。
图20根据一个实施方案描绘探测器1140的特征。探测器1140与基于超声的脉管(例如，静脉)可视化结合使用，来为针1200和/或导管1172插入脉管系统做准备。这样的可视化提供实时的超声引导并且辅助减少与这样的导入相关联的典型并发症，包括意外动脉穿孔、血肿、气胸等等。
手持探测器1140包括容纳有压电阵列的头部1180，当所述头部以抵住患者皮肤的方式邻近预期的插入部位1173(图19)被放置时，所述压电阵列用来产生超声脉冲并接收由患者身体反射后的所述超声脉冲的反射波。探测器1140还包括多个控制按钮1184(图19)来控制系统，因而，排除了临床医生到无菌区域(该无菌区域是在形成插入部位之前围绕患者插入部位形成的)之外来控制系统1110的需要。
这样，在一个实施方案中，在导管1172的导入以通过脉管系统朝向意图的目的地进行导管1172的最终推进之前，临床医生采用系统1110的超声成像部分来确定适当的插入部位并形成例如利用针1200的脉管进入。
图18示出探测器1140还包括按钮和存储器控制器1142，用来控制按钮和探测器操作。在一个实施方案中，按钮和存储器控制器1142可以包括非易失性存储器，例如EEPROM。按钮和存储器控制器1142与控制台1120的探测器接口1144进行可操作的通信，探测器接口1144包括用于与所述探测器压电阵列接口连接的压电输入/输出部件1144A，以及用于与按钮和存储器控制器1142接口连接的按钮和存储器输入/输出部件1144B。
如在图20中可见的，探测器1140包括传感器阵列1190，用于在如上面所论述的那些超声成像过程期间检测针1200的位置、定向和移动。如下面将进一步详细描述的，传感器阵列包括嵌入在探测器的壳体中的多个磁传感器1192。传感器1192被配置来检测与针1200相关联的磁场并且使得系统1110能够追踪针。尽管在本文中被配置为磁传感器，理解的是，如将描述的，传感器1192可以是其他类型和结构的传感器。此外，尽管在图20中传感器阵列1190的传感器1192被示出是与探测器1140一起被包括的，传感器阵列1190的传感器1192可以被包括在与探测器分离的部件中，例如分离的手持设备。在本实施方案中，传感器1192以平面结构被设置在探测器1140的顶面1182下方，然而理解的是，传感器可以以其他结构来布置，例如成拱形或半圆形布置。
在本实施方案中，每个传感器1192包括三个正交的传感器线圈，用来使得磁场在三个空间维度上能够进行检测。这样的三维(“3-D”)磁传感器可以例如从新泽西州莫里斯镇的霍尼韦尔感测和控制公司(Honeywell Sensing and Control ofMorristown，NJ)购买。此外，本实施方案的传感器1192被配置为霍尔效应传感器，然而可以使用其他类型的磁传感器。另外，多个一维磁传感器而不是3-D传感器可以根据需要被包括和布置，来实现1-D、2-D或3-D检测能力。
在本实施方案中，五个传感器1192被包括在传感器阵列1190中，从而使得针1200的检测不仅是在三个空间维度(即，X、Y、Z坐标空间)上，而且还在针自身的俯仰和偏向定向上能够进行检测。注意的是，在一个实施方案中，传感器1192中的两个或更多个正交感测部件使得磁元件1210的俯仰和偏向姿态能够被确定，并且由此使得针1200能够被确定。
在其他实施方案中，在传感器阵列中可以采用更少或更多的传感器。更一般地，理解的是，传感器阵列的传感器的数目、大小、类型和排布可以不同于本文所明确示出的。
图21A和21B根据一个实施方案示出这样的针1200的一个实施例的细节，该针1200可以与引导系统1110结合使用来如图19所示的进入患者的目标内部身体部分。具体地，针1200包括空心套管1202，该空心套管1202限定近侧端1202A和远侧端1202B。在本实施方案中，毂1204被附接到套管1202的近侧端1202A并且包括开口端1204A，该开口端1204A被配置为连接器来连接各种设备。事实上，毂1204的开口端1204A与空心套管1202连通，从而导丝、探针或者其他部件可以通过该毂被送入该套管。
如图21A和21B中所示的，磁元件1210与毂1204一起被包括。如在图21B中最佳可见的，磁元件1210在本实施方案中为永久磁体，包括例如铁磁物质，并且为环形的，以限定与空心套管1202对准的孔1212。这样配置的，磁元件1210产生由超声探测器1140的传感器阵列1190可检测的磁场，以如下面进一步描述的，使得针1200的位置、定向和移动能够被系统1110追踪。
在其他实施方案中，理解的是，许多其他类型、数目和大小的磁元件可以与针1200或其他医疗部件一起使用，来使得针1200或其他医疗部件能够被本引导系统追踪。
现在参考图22A和22B，图22A和22B示出系统1110的超声探测器1140和针1200在适当的位置并且准备好来通过患者的皮肤表面1220进行其插入，以进入目标内部身体部分。特别地，探测器1140被示出为其头部1180以抵住患者皮肤的方式被放置并且产生超声束1222，从而以超声的方式对患者皮肤表面1220下方的脉管1226的部分进行成像。脉管1226的超声图像可以被描绘在系统1110的显示器1130上(图19)。
如上面所述的，系统1110在本实施方案中被配置来检测上面描述的针1200的位置、定向和移动。特别地，探测器1140的传感器阵列1190被配置来检测与针1200一起被包括的磁元件1210的磁场。传感器阵列1190的每个传感器1192被配置来在三个维度空间上以空间的方式检测磁元件1210。由此，在系统1110的操作期间，由每个传感器1192感测的针的磁元件1210的磁场强度数据被传送到处理器(例如控制台1120的处理器1122(图18))，该处理器实时计算磁元件1210的位置和/或定向。
具体地，并且如图22A和22B中所示的，磁元件1210在X、Y和Z坐标空间中相对于传感器阵列1190的位置可以由系统1110使用传感器1192所感测的磁场强度数据来确定。此外，图22A示出磁元件1210的俯仰也可以被确定，而图22B示出磁元件的偏向可以被确定。系统的探测器1140、控制台1120或其他部件的适合电路可以提供这样的位置/定向所需的计算。在一个实施方案中，磁元件210可以使用以下美国专利中的一个或更多个的教导来被追踪：No.5,775,322、No.5,879,297、No.6,129,668、No.6,216,028以及No.6,263,230。前述美国专利的内容通过引用被整体并入本文。
系统1110确定的上述位置和定向信息以及套管1202的长度和磁元件1210相对于远侧针末端的位置被系统获知或者被输入到系统中，使得该系统能够准确地确定针1200的整个长度相对于传感器阵列1190的位置和定向。可选地，磁元件1210和远侧针末端之间的距离被系统1110获知或者被输入到系统1110中。这又使得系统1110能够将针1200的图像叠置到由探测器1140的超声束1222产生的图像上。图23A和23B示出这样的针到超声图像上的叠置的实施例。具体地，图23A和23B每个示出例如可以被描绘在显示器1130(图19)上的屏幕截图1230。在图23A中，超声图像1232被示出，包括患者皮肤表面1220和皮下脉管1226的描绘。例如，超声图像1232对应由图22A和22B中所示的超声束1222获取的图像。
屏幕截图1230进一步示出表征如上所描述的由系统1110确定的实际针1200的位置和定向的针图像1234。因为系统能够确定针1200相对于传感器阵列1190的位置和定向，所以系统能够准确地确定针1200相对于超声图像1232的位置和定向并且将其叠置到超声图像1232上，来在显示器1130上描绘为针图像1234。针图像1234在超声图像1232上的安置的调节由系统1110的处理器1122或其他适合的部件所执行的适合的算法来进行。
传感器1192被配置来在系统1110的操作期间持续检测针1200的磁元件1210的磁场。这使得系统1110能够持续更新针图像1234的位置和定向来在显示器1130上进行描绘。因此，针1200的推进或其他移动通过显示器1130上的针图像1234被实时地描绘。注意的是，系统1110能够随着探测器1140和针1200在放置过程或其他动作期间发生的移动，在显示器1130上持续地更新超声图像1232和针图像1234二者。
图23A进一步示出在一个实施方案中，系统1110可以基于如针图像1234所描绘的针1200的当前位置和定向来描绘投影途径1236。投影路径1236辅助临床医生确定如由显示器1130上的针图像1234描绘的针1200的当前定向是否将导致抵达期望的内部身体部分目标，例如本文中所示的脉管1226。再者，随着针图像1234的定向和/或位置改变，投影路径1236被系统1110相应地修改。指示投影路径1236穿过超声图像1232的平面的所在位置的目标1238也可以被系统1110描绘在显示器1130上。如图23A中所示的，在本实施例中，目标1238位于被描绘在超声图像1232中的脉管1226内。注意的是，目标1238在显示器1130上的位置也可以在针1200和/或超声图像1232被调整时而被修改。屏幕截图1230还包括可能性区域1239(此处被描绘为盒子)，该可能区域1239指示系统由于以下原因造成的误差的任何可能余量：针长度、针刚性和挠曲、磁元件的场强度、磁干扰、磁元件的磁轴与针的纵轴的对准上可能的偏差、传感器阵列相对于超声成像平面的定向等。
图23B示出，在一个实施方案中，屏幕截图1230可以被这样配置，以致超声图像1232和针图像1234被定向来在三个维度方面被显示。这使得如针图像1234所描绘的针1200的角度和定向能够被确定并且能够与超声图像1232所成像的意图目标进行比较。应当注意的是，屏幕截图1230仅仅是系统1110产生的用于显示的可能描绘方式的实施例；事实上，可以使用其他可视描绘方式。进一步注意的是，被成像的身体的特定区域仅仅是实施例；系统可以被用来以超声方式成像各种身体部分，并且应当不限于在附图中所明确描绘的内容。此外，如果期望的话，如本文所描绘和描述的系统可以被包括作为更大系统的部件，或者可以被配置为独立(stand-alone)设备。再者，理解的是，除可视显示器1130外，系统1110还可以采用听觉信息(例如嘟嘟声、音调等)来在针的安置和插入患者期间辅助临床医生。
如上面所述的，在一个实施方案中，对于系统1110而言需要的是获知针1200的总长度以及磁元件1210在针1200上的位置，以使得能够进行针图像1234和图23A和23B的屏幕截图1230的其他特征的准确描绘。系统1110可以以各种方式被告知这些和/或其他相关的参数，包括由系统扫描被包括在针上或者与针一起被包括的条码，与针一起包括射频识别(“RFID”)芯片来由系统进行扫描，针的彩色编码，临床医生将参数手动输入到系统中等。例如，RFID芯片1354被包括在图33A中所示的针1200上。系统1110的探测器1140或其他部件可以包括RFID读取器来读取包括在RFID芯片1354上的信息，例如针1200的类型或长度等。用于将针参数输入到系统1110中或者检测参数的这些和其他方式因此被考虑。
在一个实施方案中，针的长度(或者医疗部件的其他方面)可以通过探测器/系统对磁元件的特征(例如其场强度)的测量来确定。例如，在一个实施方案中，针的磁元件可以被安置在离探测器一预先确定的距离处或者在相对于探测器处于一预先确定的位置。在磁元件被这样安置的情况下，探测器的传感器阵列检测和测量磁元件的场强度。系统可以比较测量的场强度与对应于不同针长度的可能场强度的储存列表。系统可以匹配这两个强度并且确定针长度。针定位和随后的针插入则可以如本文所描述的那样来进行。在另一实施方案中，不是将磁元件保持在一预先确定的位置不动，而是磁元件可以相对于探测器被移动，以致探测器获得多个场强度读数。可以被改变来将不同场强度赋予一组磁元件的方面包括磁元件的大小、形状和构造等。
根据一个实施方案在此给出关于使用系统1110结合对患者的目标内部身体部分(“目标”)进行超声成像而引导针或其他医疗设备的进一步的细节。在装配有磁元件的针1200安置在离包括传感器阵列1190的超声探测器1140一适当距离(例如，两英尺或更多)处的情况下，探测器被用来以超声方式对针意图经由皮下插入而横穿的患者体内的目标进行成像，来在系统1110的显示器1130上进行描绘。然后启动系统1110的校准，其中由控制台1120的处理器1122执行算法来确定在将进行过程的地方附近的任何环境磁场的基线。如上面所论述的，例如通过使用者输入、自动检测或者以另一适合的方式，系统1110同样被告知针1200的总长度，和/或磁元件相对于远侧针末端的位置。
针1200然后被带入探测器1140的传感器阵列1190的传感器1192的范围。每个传感器1192检测与针1200的磁元件1210相关联的磁场强度，数据被传送到处理器1122。在一个实施方案中，这样的数据在被处理器需要之前可以被储存在存储器中。当传感器1192检测磁场时，处理器1122执行适合的算法来计算针1200的磁元件1210在空间中的预测地点相对于探测器的磁场强度。处理器1122然后比较由传感器1192检测的实际磁场强度数据和计算的场强度值。注意的是，这一过程在上面所指出的美国专利中被进一步描述。这一过程可以被反复地进行直到针对预测地点的计算值匹配测量数据。一旦出现这样的匹配，磁元件1210就已经在三维空间中在位置上被定位。使用如由传感器1192检测的磁场强度数据，磁元件1210的俯仰和偏向(即，定向)也可以被确定。结合已知的针1200的长度以及针的远侧末端相对于磁元件的位置，这使得可以由系统1110对针的位置和定向的准确表征能够进行并且能够在显示器1130上被描绘为可视模型，即针图像1234。注意的是，在一个实施方案中，系统1110的预测值和实际检测值必须在预先确定的容差或置信水平内匹配来使得针描绘能够进行。
如上所描述的针1200的可视针图像1234的描绘在本实施方案中通过将针图像叠覆在显示器1130的超声图像1232上来进行(图23A、23B)。如由处理器1122或其他适合的部件执行的系统1110的适合的算法进一步使得投影路径1236、目标1238以及可能区域1239(图23A、23B)能够被确定并且能够在显示器1130上被描绘在目标的超声图像1232之上。上述的预测、检测、比较和描绘过程被反复地进行来持续实时追踪针1200的移动。
鉴于上述内容并且参照图24，理解的是，在一个实施方案中，用于引导针或其他医疗部件的方法1240包括各种阶段。在阶段1242，患者的目标内部身体部分由成像系统来成像，例如，举例说明，超声成像设备。
在阶段1244，诸如针的医疗部件的可检测特征由与成像系统一起被包括的一个或更多个传感器感测。在本实施方案中，针的可检测特征为与针1200一起被包括的磁元件1210的磁场，并且传感器为被包括在与超声探测器1140一起被包括的传感器阵列1190中的磁传感器。
在阶段1246，医疗部件相对于目标内部身体部分的位置通过感测可检测特征来在至少两个空间维度上被确定。如上所述的，在本实施方案中由控制台1120的处理器1122进行这样的确定。
在阶段1248，表征医疗部件的位置的图像与目标内部身体部分的图像结合来在显示器上进行描绘。阶段1250示出阶段1244-1248可以被反复地重复，来描绘医疗部件相对于成像目标的推进或其他移动，例如，举例说明，针1200朝向脉管1226的皮下插入(图23A、23B)。
理解的是，处理器1122或其他适合的部件可以计算附加方面，包括可能区域1239和目标1238(图23A、23B)来在显示器1130上进行描绘。
理解的是，在一个实施方案中，传感器阵列无需原本就被并入超声成像设备，而是可以以其他方式被包括在其中。图25示出这种情况的一个实施例，其中包括传感器阵列1190的传感器1192的可附接的传感器模块1260被示出为附接到超声探测器1140。这样的配置使得如本文所描述的针引导能够结合标准的超声成像设备(即，这样的设备，所述设备不包括集成到超声探测器中的传感器阵列或者被配置来如上所描述的那样定位和追踪针的处理器和算法)来实现。这样，在一个实施方案中，传感器模块1260包括这样的处理器和算法，该处理器和算法适合来定位和追踪针或其他医疗部件并且适合来在显示器上描绘针的可视图像以叠覆到超声图像上。在一个实施方案中，传感器模块1260可以与模块显示器1262一起被包括，用来描绘针追踪。引导系统的这些和其他配置因此被考虑。
图26示出在一个实施方案中，针握持器可以被用来在如已经被描述的由系统1110进行的超声成像和针引导过程期间容置和推进针1200。如所示的，针握持器1270为手枪形并且包括触发器1272，用来在按压触发器时通过使针在纵向上移动离开握持器的筒而选择性地推进针1200或者其他适合的医疗部件。这样配置的，针握持器1270便利于以临床医生的一手来操作针而另一手抓握和操纵超声探测器1140。此外，针握持器1270可以例如通过马达、棘轮结构、液压/气动驱动器等来提供针移动/转动辅助。此外，计时构件可以被包括在针握持器1270上，以辅助确定针1200的远侧末端的定向并且便利针的转动。
在一个实施方案中，针握持器1270可以被可操作地连接到系统1110，以致当针套管1202的远侧端1202B到达目标内部身体部分或者针截切(intercept)超声平面时通过针握持器的推进被自动停止。在又另一实施方案中，磁元件可以与针握持器而不是针自身一起被包括。当被临时附接到针握持器时，针由此可以被引导系统定位和引导而无需磁元件被直接附接到针。
注意的是，还可以采用其他传感器配置。在一个实施方案中，环形传感器可以被配置来通过限定于环形传感器中的孔来接纳针的套管。这样设置的，针的磁元件邻近环形传感器被安置，这使得系统能够准备好进行磁元件的检测和针的定位。在一个实施方案中，环形传感器可以被附接到探测器的表面。
图27和28描绘根据另一实施方案的引导系统1110的部件，其中探测器1140和针1200之间的基于光的交互被用来使得针的追踪和引导能够进行。特别地，探测器1140包括安置在探测器表面上的光学/光源(optical/light source)(例如LED1280)和光电检测器1282。理解的是，光源和检测器可以被配置来产生和检测各种范围(包括可见、红外等)的光信号。
针毂1204包括反射表面1286，能够反射由LED1280产生并且入射到其上的光。如在图28中所示的，由LED1280射出的光被针1200的反射表面1286反射，光的一部分被光电检测器1282接收和感测。如在先前的实施方案中，系统控制台1120的处理器1122可以被用来接收光电检测器1282的感测数据并且计算针1200的位置和/或定向。如前面的，针1200的长度和/或反射表面相对于针1200的远侧端的位置被输入系统1110，或者以其他方式为系统1110可检测的或者被系统1110获知。注意的是，反射表面可以被包括在针上的其他位置处。
鉴于上述内容，理解的是，在本实施方案中，与前面实施方案的磁元件1210的磁场特征相比，针1200的可检测特征包括反射表面1286的反射率，并且与前面实施方案的磁传感器1192相比，传感器包括光电检测器1282。应当理解的是，在一个实施方案中，上面描述的配置可以被反过来，其中光源与针或医疗部件一起被包括。在这种情况下，光从针射出并且由与探测器1140一起被包括的光电检测器1282检测，从而使得针的定位和追踪能够进行。电源(例如钮扣电池等)可以与针一起被包括，来为针的光源供电。
更一般地，理解的是，针或医疗部件可以包括这些或其他可检测特征中的一个或更多个，来使得针能够被朝向患者身体中的目标追踪和引导。其他可检测特征方式的非限制性实施例包括电磁方式或射频方式(“RF”)(见，例如下面的图29-30)以及放射性方式。关于RF方式，理解的是，一个或更多个同步或异步脉冲频率源可以与针一起被包括来使得针的检测能够通过适合的传感器(一个或多个)来进行。或者，RF第一源可以与无源磁体耦合作为第二源。
图29和30描绘根据一个实施方案的引导系统的部件，其中探测器1140和针1200之间的EM信号交互被用来使得针的追踪和引导能够进行。特别地，在图29中，针1200包括设置在其中的探针1298。探针1298包括EM线圈1290，EM线圈1290经由绳缆1292可操作地连接到探测器1140。以这种方式，EM线圈1290可以由包括在探测器1140或者系统控制台1120中的适合的部件驱动，以致EM线圈在操作期间发射EM信号。
适合来检测由探针1298的EM线圈1290发射的EM信号的传感器1294被包括在探测器1140中。在本实施方案中，传感器1294为三轴传感器，用于检测EM信号的相应正交分量，然而还可以采用其他线圈和传感器配置。这样配置的，针1200的位置和定向可以通过EM信号三角测量或其他适合的过程被确定并且由系统以与上面已经描述的类似的方式被显示。如在前面的实施方案中的，系统控制台1120的处理器1122(图18)可以被用来接收EM传感器1294的感测数据并且计算针1200的位置和/或定向。如前面的，针1200的长度和/或EM线圈1290相对于针1200的远侧端的位置被输入系统，或者以其他方式为系统可检测的或被系统获知。
图30示出图29的EM配置的变化方式，其中EM部件的各自的位置是被反过来的：EM线圈1290被包括在探测器1140中并且EM传感器1294与设置在针1200中的探针1298一起被包括。注意的是，在图29和30的实施方案中，EM线圈1290和EM传感器1294之间经由绳缆1292的可操作的连接使得设置在探针1298中的部件能够被系统1110驱动。这还使得由EM线圈1290发射的和由EM传感器1294检测的特定EM频率/多个频率能够一致。在一个实施方案中，图29中所示的配置可以改变，其中没有绳缆来可操作地连接EM线圈和EM传感器；相反，探针的EM线圈作为与探测器及其EM传感器分离的部件来操作并且由独立的电源(例如电池)供电。在这种情况下，探测器/系统包括适合的信号处理部件，该适合的信号处理部件被配置来检测由EM线圈发射的EM信号并且根据需要对该EM信号进行处理，从而对针进行定位。
注意的是，EM线圈和EM传感器可以被包括在除本文所描绘的以外的其他位置上。例如，EM线圈可以被包括在针自身上，或者在可附接到针的近侧端的连接器上。
图31A-31D给出根据一个实施方案被配置的针1200的进一步的细节，其中针包括毂1304，套管1202从毂1304延伸。限定有孔1312的磁元件1310被包括在壳体1314的腔1314A中。壳体1314包括螺纹，从而以可螺接的方式接合针毂1304或者针或医疗部件的其他适合的部件。以这种方式，磁元件1310是经由壳体1314以可移除的方式可附接到针1200的。由此，磁元件1310无需被永久性地附着于针1200或者与针1200一起被包括，而是可以当不再需要基于磁的针引导时从其中被移除。此外，这使得磁元件能够被附接到诸多不同类型和大小的针。注意的是，在本实施方案中，针1200还包括向远侧可滑动的针安全部件1320，用于在从患者移除针时安全地隔离针的远侧末端。进一步注意的是，除了本文明确示出和描述的内容之外，可以采用其他可移除的磁元件。
图32-33B给出包括磁元件的针1200的进一步的实施例。在图32中，两个条状的磁元件1340被这样设置，以从针1200的毂1334正交地延伸，图示说明磁元件无需被平行于针的纵轴来定向。在图33A-33B中，四个磁元件1350被包括在针毂1344中，示出多于一个的磁元件可以与针一起被包括。这样的配置可以被采用，例如，其中受限的空间防止一个磁元件被使用。注意的是，本文中的磁元件的数目、形状和排布仅仅是诸多可能的配置的一个实施例。
图34A-34G给出磁元件1360的各种示例性的配置，该磁元件1360限定用于接纳针的套管通过其中的孔。示出磁元件1360的各种形状配置，包括方形(图34A)、六边形(图34B)、三角形(图34C)、矩形(34D)、椭圆形(图34E)、八边形(图34F)以及四面金字塔(图34G)。在附图中所示的磁元件仅仅是可以被用来限定磁元件的众多几何图形和其他形状的实施例；事实上，还考虑没有在本文中明确示出的其他形状。
图35和36描绘又另一实施方案，其中探针1390被包括来可移除的插入到针1200的空心套管1202中。多个永久磁体1392(例如相互以端对端的方式堆叠的固体圆柱形铁磁体)被包括在探针1390的远侧端。如图36中所示的，探针1390在针1200插入患者体内期间被接纳在针套管1202中。传感器环1396或其他适合的磁传感器可以与探测器1140一起被包括或者邻近探测器1140，来使得磁体1392的磁场的检测能够进行，由此使得引导系统能够以与结合图5A-7进行描述的方式类似的方式检测针1200的位置和定向并且将针1200的位置和定向的图像叠置在由探测器1140产生的超声图像上。
图35和36由此图示说明磁元件(一个或多个)可以以各种各样的方式中的任一种来配置。在一个实施方案中，例如，磁元件可以沿探针长度被更向近侧地设置。在另一实施方案中，探针自身可以被磁化或者由磁材料构成。理解的是，探针可以以诸多不同方式中的一种来配置，这样的类似实施例可以参见题为“医疗器材定位方式(Medical InstrumentLocation Means)”的美国专利No.5,099,845和2006年8月23日递交的、题为“探针设备和制造方法(Stylet Apparatuses and Methods ofManufacture)”的美国专利申请公开No.2007/0049846，这二者通过引用被整体并入本文。这些和其他变化方式因此被考虑。
在此应当理解的是，如本文所使用的“探针”可以包括被配置来可移除的放置在针的内腔中以辅助针在患者体内的放置的各种各样的设备(包括导丝)中的任一种。在一个实施方案中，探针可以包括向远侧延伸通过针的钝的远侧端的尖端，从而使得钝的针能够被插入患者体内。注意的是，在一个实施方案中，探针使针硬化，从而使得针在插入期间的意外弯曲最小。
图37描绘又另一可能的实施方案，其中针1200包括设置在针套管1202的近侧端1202A的远侧的环形或环状磁体1400。注意的是，在其他实施方案中，磁体1400可以被安置在沿套管1202的长度的多个位置中的一个上。磁体1400相对更靠近远侧针末端的安置减少针的意外弯曲对确定和显示针的位置的影响。在又另一实施方案中，针自身可以被磁化。进一步注意的是，系统的传感器和源(例如，磁体)的相对放置可以被反过来。这些和其他配置也被考虑。此外，注意的是，本文的论述可以被应用到除了超声以外的其他成像方式，包括MRI、X射线和CT扫描等。
图38描绘被包括在探针(例如，举例说明，图35和36中所示的探针1390)上的应变计1410。应变计1410可以经由导电路径1414可操作地连接到系统1110的探测器1140、控制台1120(图18)或者其他部件。例如，导电路径1414的一个实施例包括设置在探针1390中或者沿探针1390设置的一条或更多条导线。这样连接的，考虑到针1200的弯曲将导致探针1390出现类似弯曲，应变计1410用作换能器并且可以提供与针插入过程期间探针1390被设置在其中的针的弯曲相关的数据。
经由应变计1410的弯曲感测的这些数据可以被传送至系统1110的处理器1122(图18)或其他适合的部件并且由系统1110的处理器1122或其他适合的部件进行解释，从而将这样的弯曲以及由探测器传感器1192(图20)进行的磁元件的检测包括在一起，来计算针1200的位置，特别是针1200的远侧末端的位置。这导致定位和描绘针远侧末端的位置的准确性被提高。事实上，图39A示出由于探针1390的弯曲导致的应变计1410在一个方向上的挠曲，其中图39B示出应变计在另一个方向上的挠曲。这样的探针弯曲由此通过应变计1410(在一个实施方案中通过应变计中的电阻的改变)来检测，并且被传送至系统1110来用于计算针位置。注意的是，其他适合的传感器和计量器可以可选择地被用来测量针/探针弯曲，例如，举例说明，包括图40中所示的挠曲传感器1420以及基于电容和光纤的应变计/传感器。此外，在一个实施方案中，传感器/计量器可以被直接放置在针/医疗部件上。
本发明的实施方案可以以其他具体的形式实施，而不偏离本发明的精神。所述已描述的实施方案应被认为是在各方面都仅是作为图示说明性的而非限制性的。因而，本发明实施方案的范围由所附的权利要求书而非前述说明书所示出。在权利要求书的含义和等同范围内的所有变化都应被包含在本发明的范围内。

Claims (28)

1.一种用于结合成像技术将针插入到患者身体中的引导系统，所述系统包括：
成像设备，所述成像设备包括探测器，所述成像设备产生内部身体部分目标的图像；
探针，所述探针可移除地设置在所述针中，所述探针包括至少一个磁元件；
与所述探测器一起被包括的至少一个传感器，所述至少一个传感器感测所述探针的所述磁元件的磁场；
处理器，所述处理器使用与所述至少一个传感器感测的磁场相关的数据，来在至少两个空间维度上确定所述针的位置；以及
显示器，所述显示器描绘所述针相对于所述目标的位置连同所述目标的图像。
2.如权利要求1所限定的引导系统，其中所述磁元件包括紧邻彼此被放置的多个无源铁磁体。
3.如权利要求2所限定的引导系统，其中所述至少一个传感器被设置在所述探测器的外部部分上，并且其中所述多个铁磁体邻近所述探针的远侧端被设置。
4.如权利要求3所限定的引导系统，其中所述至少一个传感器包括环形传感器，所述环形传感器围绕所述探测器的头部部分被接纳。
5.如权利要求1所限定的引导系统，其中所述至少一个传感器包括正交感测部件，从而使得所述针的所述磁元件在三个空间维度上的位置以及所述磁元件的俯仰和偏向姿态的确定能够进行。
6.如权利要求1所限定的引导系统，还包括在所述探针上的应变计来检测所述针的弯曲。
7.一种用于引导针插入到患者身体中的引导系统，所述引导系统包括：
超声成像设备，所述超声成像设备包括探测器，用于以超声的方式对内部身体部分目标进行成像；
与所述针一起被包括的磁元件；
与所述探测器一起被包括的多个磁传感器，所述多个磁传感器每个感测所述针的所述磁元件的磁场；
处理器，所述处理器接收所述传感器感测的磁场数据，来在三个空间维度上确定所述针的位置；以及
显示器，所述显示器描绘所述针的被确定的位置连同所述目标的图像。
8.如权利要求7所限定的引导系统，其中所述磁元件包括设置在所述针的毂中的永久磁体，并且其中所述磁元件和所述磁传感器之间不存在物理连接。
9.如权利要求7所限定的引导系统，其中所述针还包括彩色编码、条码以及RFID芯片中的一个，来使得所述引导系统能够识别所述针的长度，并且其中所述磁传感器以拱形布置被分布在所述探测器内。
10.如权利要求7所限定的引导系统，其中所述磁元件包括永久磁体，所述永久磁体限定孔，所述针的套管通过所述孔被接纳，并且其中所述永久磁体的形状限定方形、三角形、矩形、椭圆形、八边形以及金字塔中的一个。
11.如权利要求7所限定的引导系统，其中所述磁元件包括多个永久磁体，所述多个永久磁体被包括在所述针的毂中。
12.如权利要求7所限定的引导系统，其中所述磁元件包括至少一个条磁体，所述至少一个条磁体被设置为与所述针的套管的纵轴正交。
13.一种用于引导针插入到患者身体中的引导系统，所述引导系统包括：
超声成像设备，所述超声成像设备包括探测器，用于以超声的方式对内部身体部分目标进行成像；
围绕所述针的套管设置的环形磁体；
与所述探测器一起被包括的至少一个传感器，所述至少一个传感器感测所述针的所述磁体的磁场；
处理器，所述处理器接收所述至少一个传感器感测的磁场数据，来在三个空间维度上确定所述针的位置；以及
显示器，所述显示器描绘所述针的被确定的位置连同所述目标的图像。
14.如权利要求13所限定的引导系统，其中所述环形磁体被设置在所述针套管的近侧端的远侧。
15.如权利要求13所限定的引导系统，其中所述针还包括应变计来检测所述针的弯曲。
16.如权利要求15所限定的引导系统，其中所述应变计被包括在可移除地接纳在所述针中的探针上。
17.如权利要求13所限定的引导系统，其中所述至少一个传感器包括与所述探测器一起被包括的环形传感器。
18.如权利要求17所限定的引导系统，其中所述至少一个传感器被设置在邻近所述探测器的头部部分的所述探测器的外部部分上。
19.一种用于引导针插入到患者身体中的引导系统，所述引导系统包括：
在物理上独立于所述针的超声成像探测器，用于以超声的方式对内部身体部分目标进行成像；
与所述针相关联的磁元件；
与所述探测器相关联的多个磁传感器，所述多个磁传感器每个感测所述磁元件的磁场；
处理器，所述处理器接收所述传感器感测的磁场数据，来确定所述针的位置和定向；以及
显示器，所述显示器描绘所述超声成像探测器获得的所述内部身体部分目标的图像以及相对于所述图像定向和定位的所述针的叠置表征。
20.如权利要求19所限定的引导系统，其中所述磁元件被设置在所述针的毂内，并且所述多个磁传感器被设置在所述探测器内。
21.一种引导系统，所述引导系统包括：
超声成像探测器，用于以超声的方式对内部身体部分目标进行成像；
与所述成像探测器分离的医疗设备，所述医疗设备被配置用于插入到所述内部身体部分目标中，所述医疗设备具有与其相关联的磁场；
与所述探测器相关联的多个磁传感器，所述多个磁传感器每个感测所述医疗设备的磁场；
处理器，所述处理器接收所述磁传感器感测的磁场数据，来确定所述医疗设备的位置和/或定向；以及
显示器，所述显示器显示所述超声成像探测器获得的所述内部身体部分目标的图像以及相对于所述图像定位和/或定向的所述医疗设备的叠置表征。
22.如权利要求21所限定的引导系统，其中所述医疗设备为针，并且所述内部身体部分目标为血管。
23.如权利要求21所限定的引导系统，其中所述磁场由耦合到所述医疗设备的磁元件提供。
24.如权利要求23所限定的引导系统，其中所述磁元件被设置在所述医疗设备的毂内，并且所述多个磁传感器被设置在所述探测器内。
25.如权利要求23所限定的引导系统，其中所述磁元件为永久磁体。
26.如权利要求21所限定的引导系统，其中所述磁传感器中的每个被配置用于在三个空间维度上检测磁场。
27.如权利要求26所限定的引导系统，其中所述磁传感器中的每个包括正交传感器线圈。
28.如权利要求21所限定的引导系统，其中所述磁传感器被配置来连续地检测所述磁场，并且其中所述系统被配置来持续更新所述图像，以致所述医疗设备相对于所述图像的位置和/或定向随着所述探测器和所述医疗设备的同时移动的发生而被持续更新。
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