CN105072989A - Iconic representations relating to systems for placing a medical device - Google Patents

Iconic representations relating to systems for placing a medical device Download PDF

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Publication number
CN105072989A
CN105072989A CN201480010988.8A CN201480010988A CN105072989A CN 105072989 A CN105072989 A CN 105072989A CN 201480010988 A CN201480010988 A CN 201480010988A CN 105072989 A CN105072989 A CN 105072989A
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China
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catheter
probe
indicator
system
patient
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CN201480010988.8A
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Chinese (zh)
Inventor
A·K·米森纳
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C·R·巴德股份有限公司
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Application filed by C·R·巴德股份有限公司 filed Critical C·R·巴德股份有限公司
Priority to PCT/US2014/022019 priority patent/WO2014138652A1/en
Publication of CN105072989A publication Critical patent/CN105072989A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/06Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061Determining 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
    • A61B5/062Determining 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/04Measuring bioelectric signals of the body or parts thereof
    • A61B5/0402Electrocardiography, i.e. ECG
    • A61B5/0408Electrodes specially adapted therefor
    • A61B5/042Electrodes specially adapted therefor for introducing into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/04Measuring bioelectric signals of the body or parts thereof
    • A61B5/0402Electrocardiography, i.e. ECG
    • A61B5/0452Detecting specific parameters of the electrocardiograph cycle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/742Details of notification to user or communication with user or patient ; user input means using visual displays
    • A61B5/743Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00ICT specially adapted for the handling or processing of medical images
    • G16H30/20ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00ICT specially adapted for the handling or processing of medical images
    • G16H30/40ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0006ECG or EEG signals
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart. Iconic representations for depiction on the display of the system and relating to positional and other characteristics of the catheter or medical device are also disclosed.

Description

与用于放置医疗设备的系统有关的图标表征 Characterization icon associated with the system for placing medical devices

[0001] 对相关申请的交叉引用:本申请要求2013年3月8日提交的题目为“用于留置医疗设备的引导的图标表征(Iconic Representat1ns for Guidance of an IndwellingMedical Device) ”的美国临时专利申请N0.61/775,397的优先权,所述专利申请通过引用被全部并入本文。 [0001] CROSS-REFERENCE TO RELATED APPLICATIONS: This application claims the title March 8, 2013, entitled "Characterization of an icon for an indwelling medical device guiding (Iconic Representat1ns for Guidance of an IndwellingMedical Device)" U.S. Provisional Patent Application N0.61 / 775,397 filed a patent application is incorporated herein by reference in its entirety.

发明内容 SUMMARY

[0002] 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。 [0002] brief overview, embodiments of the present invention relates to an integrated catheter placement system, the system is configured for accurately placing a catheter in a patient's vasculature. 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探测并便利对任何末端错位的纠正。 The integrated system using at least two forms of improving catheter placement accuracy: 1) ultrasound-assisted guidance for introducing the catheter into the patient's vasculature; and 2) a tip location system ( "TLS"), or catheter vasculature to promote the process of magnetically-based (e.g., permanent magnets or electromagnets) tracking the catheter tip, to detect and facilitate correction of any tip malposition during such advancement in.

[0003] 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。 [0003] In one embodiment, the integrated control system includes a processor having a system console for temporarily placing on a portion of the patient's body tip location sensor, and an ultrasonic probe. 所述末端定位传感器在导管被设置在脉管系统中时探测设置在导管内腔中的探针的磁场。 The magnetic field probe sensor tip location when the catheter is disposed in the vasculature probe disposed in the catheter lumen. 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。 Prior to introducing the catheter into the vasculature, the ultrasonic probe to ultrasonically imaging a portion of the vasculature. 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。 Further, the ultrasound probe includes a user input control means, said user input control means for controlling the use of ultrasonic mode ultrasound probe and using a sensor positioned in the tip end of the positioning mode.

[0004] 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。 [0004] In another embodiment, a third modality, i.e., ECG signal-based catheter tip guidance is included in the system, so that the catheter tip can be guided with respect to a patient ECG signals generated in the heart node (a node of thepatient's heart) in a desired position. 还公开了用于在患者的无菌区域和非无菌区域之间建立导电通路以使能从导管到末端定位传感器的ECG信号通路的各种装置。 Also discloses various means for establishing a conductive pathway between sterile and non-sterile regions of the patient so that the catheter tip location sensor from an ECG signal path. 这样的装置包括,例如通过在无菌屏障(例如外科手术布单)中限定的穿孔建立导电通路的连接方案,其中连接方案将穿孔隔离以防止患者的无菌区域受到污染或损害。 Such devices include, for example, establishing a conductive path connection scheme defined by perforations in the sterile barrier (e.g., a surgical drape), in which connection scheme perforated isolated to prevent contamination of the sterile field of the patient or damage.

[0005] 在进一步的实施方案中,公开了用于可视化和操控经由本导管放置系统所获取的ECG信号数据的显示的各方面。 [0005] In a further embodiment, disclosed in various aspects for visualizing and manipulating the ECG signal data acquired via the catheter placement system of the present display. 这些显示方面使临床医生能够放置所述导管或其他侵入体内的(invasive)医疗设备,以明确与所述设备相对于所述ECG信号发射节点的邻近程度(proximity)相关的信息。 These aspects of the display enables the clinician placing the catheter or other invasive body (invasive) medical devices, and specifically to the proximity of the device relative to (Proximity) the ECG signal information associated transmitting node. 在另一其他实施方案中,还公开了各种ECG传感器结构的多个方面。 In still another embodiment, there is also disclosed a plurality of aspects of the various ECG sensor structure. 在另外的实施方案中,还公开了图标表征,所述图标表征用于在所述系统的显示器上的描绘,并且所述图标表征与所述导管或医疗设备的位置的和其他的特征有关。 In further embodiments, further characterized disclosed icon, the icon is depicted on a display for the characterization of the system, and related and other features characterizing the position of the icon of the catheter or medical device.

[0006] 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。 [0006] These embodiments of the present invention and other features of the following description and appended claims will become more fully apparent from, or may be learned by practice of embodiments of the invention as set forth hereinafter be learned.

附图说明 BRIEF DESCRIPTION

[0007] 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。 [0007] The specific embodiments provided by the present invention with reference to the more particular description of the invention, the specific embodiments are illustrated in the appended drawings. 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。 It will be appreciated that these drawings depict only typical embodiments of the invention, and thus can not be considered as limiting the scope of the present invention. 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: Will be made to the accompanying drawings by using additional features and details of exemplary embodiments of the present invention are described and explained, wherein:

[0008]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; [0008] Figure 1 is an exemplary embodiment of the present invention embodiment, a block diagram depicting various elements of an integrated system for catheter placement within the vasculature;

[0009]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; [0009] Figure 2 is the integrated system of the patient and by means of FIG. 1 is a simplified view of a catheter inserted into a patient;

[0010] 图3A和3B为图1的所述集成系统的探测器的视图; [0010] Figures 3A and 3B are views of the integrated system of the detector of Figure 1;

[0011]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; [0011] As depicted in FIG. 4 is a screen shot of an ultrasound imaging on a display of the integrated system of Figure 1;

[0012]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; [0012] FIG. 5 is a vasculature in a patient is a perspective view of a probe for use with the system of FIG. 1 during placement of the catheter;

[0013] 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; [0013] FIG. 6 is depicted as an icon on a display of the integrated system of FIG. 1 (icon), indicating the position of the distal end of the catheter tip during placement in the probe of FIG. 5;

[0014]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; [0014] Figures 7A-7E depict the process of placement of the catheter tip may be depicted in various exemplary icon on the display of the integrated system of Figure 1;

[0015]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; [0015] FIGS. 8A-8C is a screenshot of an image is depicted on a display of the integrated system of FIG. 1 during placement of the catheter tip;

[0016]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; [0016] FIG 9 according to another exemplary embodiment of the present invention, a block diagram depicting various elements of an integrated catheter system for placing vasculature;

[0017]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; [0017] FIG. 10 is a patient and by means of the integrated system of FIG. 9 is a simplified view of a catheter inserted into a patient;

[0018]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; [0018] FIG. 11 is a vasculature of a patient is a perspective view of a probe for use with the integrated system of Figure 9 when the placement of the catheter;

[0019] 图12A-12E为图11的所述探针的各部分的各种视图; [0019] FIGS. 12A-12E for the probe of FIG. 11 are various views of portions;

[0020] 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(finconnector)组件的各种视图; [0020] Figures 13A-13D and FIG. 9 for the integrated fin connector system for use with various views (finconnector) assembly;

[0021] 图13E-13F为用于与图13A-13D中示出的所述鳍状连接器组件一起使用的绳缆(tether)连接器的各种视图; [0021] FIGS. 13E-13F for various views of a tether connector (tethered) for use with the FIGS. 13A-13D connected to the fin assembly illustrated;

[0022] 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; [0022] FIGS. 14A-14C are diagrams illustrating a probe tether connector and the fin connector view of the integrated sensor system of Figure 9;

[0023] 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; [0023] FIG. 15 is a tether to the probe shown in FIG. 14C, the fin connector and a cross-sectional view of the connection of the sensor;

[0024] 图16为患者的ECG迹线的简化视图; [0024] FIG. 16 is a simplified view of the ECG trace of a patient;

[0025]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; [0025] FIG 17 is a screenshot of an image is depicted on a display of the integrated system of FIG. 9 during placement of the catheter tip;

[0026] 图18为包括根据一个实施方案配置的电气触头的鳍状连接器的剖视图; [0026] FIG. 18 is a cross-sectional view of one embodiment of the fin connector comprises electrical contacts arranged;

[0027] 图19A和19B为根据一个实施方案的用于绳缆连接器和鳍状连接器的接合的电气触头保持(retent1n)系统的简化视图; [0027] Figures 19A and 19B according to one embodiment of the electrical contacts for the tether connector and the fin connector retaining engagement simplified view (retent1n) system;

[0028] 图20A-20C为用于结合本文所描述的所述集成系统的使用来通过无菌屏障建立信号通路的鳍状连接器和绳缆连接器的一个实施方案的各种视图; [0028] Figures 20A-20C various views of a fin connector and a tether connector using an embodiment of the integrated system is described herein for binding to establish a signaling pathway through a sterile barrier;

[0029] 图2IA和2IB为根据一个实施方案的用于将ECG电极电气连接到所述集成系统的传感器的连接器的各种视图; [0029] FIG 2IA and 2IB ECG electrodes are various views of one embodiment for electrically connecting the integrated system to the sensor connector;

[0030] 图22A-22C为用于通过无菌屏障建立信号通路的鳍状连接器和绳缆连接器的一个实施方案的各种视图; [0030] FIGS. 22A-22C for various views of a fin connector and a tether connector according to an embodiment of the establishment of a signaling pathway through a sterile barrier;

[0031] 图23A和23B为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的剖视图; [0031] FIGS. 23A and 23B is a cross-sectional view of a connector system in accordance with the signal path established by a sterile barrier for the embodiment;

[0032] 图24为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化侧视图; [0032] FIG. 24 according to one embodiment of a simplified side view of the connector system setup signal pathway through a sterile barrier;

[0033] 图25A和25B为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化侧视图; [0033] FIGS. 25A and 25B according to one embodiment for establishing a simplified side view of the connector system signaling pathway through a sterile barrier;

[0034] 图26A和26B为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的剖视图; [0034] FIGS. 26A and 26B is a cross-sectional view of a connector system in accordance with the signal path established by a sterile barrier for the embodiment;

[0035] 图27为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化视图; [0035] FIG. 27 is a simplified view of one embodiment of a connector system to establish a signal path through the sterile barrier;

[0036] 图28为根据一个实施方案的用于与图28中示出的连接器系统一起使用的包括无菌防护体(shield)的探针的立体视图; [0036] FIG 28 includes a probe according sterile shield body (Shield) is a perspective view of one embodiment for the embodiment of FIG. 28 is shown for use with a connector system;

[0037] 图29A和29B为根据一个实施方案的包括用于通过无菌屏障建立信号通路的连接器系统的图27的ECG模块的简化视图; [0037] FIGS. 29A and 29B comprises a connector according to system setup signal pathway through a sterile barrier view of one embodiment of a simplified view of an ECG module 27;

[0038] 图30为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化视图; [0038] 30 according to one embodiment of the connector system to establish a simplified view of the signaling pathway through a sterile barrier FIG;

[0039] 图31为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化视图; [0039] FIG. 31 is a simplified view of one embodiment of a connector system to establish a signal path through the sterile barrier;

[0040] 图32为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的元件的简化视图; [0040] FIG. 32 according to one embodiment of a simplified view of an element of the connector system to establish a signaling pathway through a sterile barrier;

[0041] 图33为根据一个实施方案的用于在无菌区域和非无菌区域之间建立导电通路的装置的视图; [0041] 33 is established between the sterile and non-sterile fields, according to one embodiment of the view of the device of FIG conductive paths;

[0042] 图34为根据一个实施方案的用于在无菌区域和非无菌区域之间建立导电通路的另一装置的视图; [0042] FIG. 34 is a further establishing a conductive pathway between sterile and non-sterile fields, according to one embodiment of a view;

[0043] 图35A-C描绘示例性P-波波形; [0043] FIGS. 35A-C depict an exemplary waveform P-;

[0044]图36为根据一个实施方案的被改进为具有无线模块的传感器的视图; [0044] FIG. 36 is be modified to a sensor module having a wireless view of an embodiment according;

[0045] 图37为根据一个实施方案的用于连接器的保持构件视图; [0045] FIG. 37 is a view of a holding member for a connector according to one embodiment;

[0046] 图38为根据一个实施方案的包括ECG传感器的导管的立体视图; [0046] FIG. 38 is a catheter comprising an ECG sensor is a perspective view of an embodiment according;

[0047] 图39为包括多个设置在导管上的电极的传感器组件的立体视图; [0047] FIG. 39 is a perspective view of a sensor assembly comprising a plurality of electrodes disposed on the catheter;

[0048] 图40A-40C描绘图39的导管的操作; [0048] FIGS 40A-40C depict the operation of the catheter of FIG 39;

[0049] 图41A-41D为根据一个实施方案的电极连接完整性指示器和系统的各种视图; [0049] 41A-41D are various views of one embodiment of an electrode connection integrity indicator and the system of Figure 1;

[0050]图42为根据一个实施方案的电极连接完整性系统的立体视图; [0050] FIG. 42 is a perspective view of one embodiment of an electrode connection integrity of the system;

[0051] 图43A和43B为根据一个实施方案的探针的剖视图,所述探针包括用于检测探针切断情况的导线环(wire loop); [0051] FIGS. 43A and 43B is a cross-sectional view of the probe according to an embodiment, the probe comprising a probe for detecting a wire loop cutting conditions (wire loop);

[0052] 图44为根据一个实施方案的图43A的探针的部分剖视图,所述探针包括具有平导线的导线环; [0052] FIG. 44 is a cross-sectional view of a portion of the probe of FIG. 43A embodiment, the probe comprises a wire ring having a flat wire;

[0053] 图45为根据一个实施方案的导管的剖视图,所述导管包括具有远侧干涉(interference)构件的探针; [0053] FIG. 45 is a cross-sectional view of a catheter according to an embodiment of the catheter comprises a probe having a distal interference (Interference) member;

[0054] 0054图46为根据另一实施方案的导管的剖视图,所述导管包括具有远侧干涉构件的探针; [0054] 0054 FIG. 46 is a cross-sectional view of a catheter according to another embodiment, said catheter comprising a probe having a distal of an interference member;

[0055] 图47A和47B为根据一个实施方案的被配置来保持导管和探针的远侧端对齐的导管和探针的远侧部分的剖视图; [0055] FIGS. 47A and 47B is a cross-sectional view of the distal end of the catheter and a distal portion of the probe catheter and probe alignment according to an embodiment is configured to hold;

[0056] 图48为根据一个实施方案的双ECG电极组件的立体视图; [0056] FIG. 48 is a perspective view of one embodiment of dual ECG electrode assembly scheme;

[0057] 图49为根据一个实施方案的包括图形的外部ECG电极组件的立体视图; [0057] FIG 49 according to an external ECG electrode assembly comprising a pattern perspective view of one embodiment;

[0058] 图50为根据一个实施方案的示出P-波特征的ECG迹线; [0058] FIG. 50 is a P- wave from the ECG shows features of an embodiment of trace;

[0059] 图51为描述根据一个实施方案的一种方法的流程图; [0059] FIG. 51 is described according to one embodiment of the method of one embodiment of a flow diagram;

[0060] 图52-55为根据本公开的实施方案的示出附加的P-波特征的ECG迹线; [0060] 52-55 The ECG trace is shown an additional feature of the P- wave embodiment of the present disclosure;

[0061] 图56A-57B为根据一个实施方案的示出关于ECG波形缩放的细节的ECG迹线; [0061] FIGS. 56A-57B is shown on the ECG waveform ECG scaled detail, according to one embodiment of the trace;

[0062] 图58为描述根据一个实施方案的一种方法的流程图; [0062] FIG. 58 is described according to one embodiment of the method of one embodiment of a flow diagram;

[0063] 图59为根据一个实施方案的包括单个ECG波形的各方面的显示窗口; [0063] FIG. 59 according to one embodiment includes a display window of individual aspects of the ECG waveform;

[0064] 图60为描述根据一个实施方案的一种方法的流程图; [0064] FIG. 60 is a flowchart of a method according to one embodiment of the described embodiment;

[0065] 图61为根据一个实施方案被配置的导管放置记录; [0065] FIG. 61 is a catheter placement record configured according to one embodiment of the embodiment;

[0066] 图62为根据一个实施方案被配置的另一个导管放置记录; [0066] FIG. 62 is recorded as another catheter is placed in accordance with one embodiment of the embodiment is arranged;

[0067]图63为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,作为本发明的实施方案可以被实践的一个示例性环境; [0067] FIG. 63 is a block diagram depicting various elements of an integrated catheter system for placing a vascular system, as an embodiment of the present invention, one exemplary environment may be practiced;

[0068] 图64为患者和借助于图63的所述集成系统被插入患者的导管的简化视图; The integrated system [0068] FIG. 64 is a patient and by means of FIG. 63 is a simplified view of a catheter inserted into a patient;

[0069] 图65示出用于在图63的所述集成系统的显示器上的描绘的各种图标,指示在导管末端的放置过程中,与图64的所述导管相关联的探针的远侧端的四维位置和定向; [0069] FIG 65 shows various icons on a display for the integrated system depicted in FIG. 63, indicated during placement of the catheter tip in the probe conduit 64 in FIG far associated side end of the four-dimensional position and orientation;

[0070] 图66示出根据一个实施方案的用于确定和描绘图65的所述图标的方法的简化流程图; [0070] FIG. 66 illustrates a simplified embodiment of a flowchart of a method for determining and depiction of the icon of Fig. 65;

[0071] 图67A-67F描绘各种示例性图标,所述示例性图标可以在导管末端的放置过程中被描绘在图63的所述集成系统的显示器上,来指示与图64的所述导管相关联的探针的远侧端的四维位置和定向; [0071] FIGS. 67A-67F depict various exemplary icon, the icon may be depicted example during placement of the catheter tip on a display of the integrated system of FIG. 63, to indicate that the conduit 64 of FIG. the distal end of the four-dimensional position and orientation of the probe is associated;

[0072] 图68A和68B示出用于在图63的所述集成系统的显示器上的描绘的示例性图标,指示在导管末端放置过程中与图64的所述导管相关联的探针的远侧端的五维位置和定向; [0072] FIGS 68A and 68B illustrate an exemplary display of the icon for the integrated system depicted in FIG. 63, the catheter probe distal indicating associated with FIG. 64 in catheter tip placement procedures end side of the five-dimensional position and orientation;

[0073] 图69示出用于在图63的所述集成系统的显示器上的描绘的示例性图标,指示在导管末端放置过程中与图64的所述导管相关联的探针的远侧端的六维位置和定向; [0073] FIG. 69 shows an exemplary display of the icon for the integrated system of FIG. 63 depicting indicating the catheter tip during placement of the catheter distal probe associated with the end 64 of FIG. six-dimensional position and orientation;

[0074] 图70示出根据一个实施方案的包括多维信息的另外的可能图标; [0074] FIG. 70 shows a further icon may include multi-dimensional information in accordance with an embodiment;

[0075] 图71示出根据一个实施方案的包括多维信息的另外的可能图标; [0075] FIG. 71 shows a further icon may include multi-dimensional information of an embodiment;

[0076] 图72示出根据一个实施方案的包括多维信息的另外的可能图标; [0076] FIG. 72 shows a further icon may include multi-dimensional information of an embodiment;

[0077]图73示出根据一个实施方案的屏幕截图,其中图标的一个实施例指示与留置设备的位置有关的信息; [0077] FIG. 73 shows a screen shot of an embodiment in which an embodiment of the example instruction icon on the position of an indwelling device;

[0078]图74示出根据一个实施方案的屏幕截图,其中图标的一个实施例指示与留置设备的位置有关的信息;以及 [0078] FIG. 74 shows a screen shot of an embodiment, wherein a position information indicating Example indwelling device icons embodiment; and

[0079]图75示出根据一个实施方案的屏幕截图,其中图标的一个实施例指示与留置设备的位置有关的信息。 [0079] FIG. 75 shows a screen shot of an embodiment, wherein a position information indicating Example embodiment indwelling device icon.

具体实施方式 Detailed ways

[0080] 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。 [0080] Referring now to the drawings, wherein like structures will be provided with like reference numbers. 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。 It will be appreciated, the characterization and schematically illustrated in the drawings exemplary embodiments of the present invention and the accompanying drawings are non-limiting, also necessarily drawn to scale.

[0081] 本发明实施方案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。 [0081] Embodiments of the invention generally relates configured for accurately placing a catheter within a patient's vasculature catheter placement system. 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探测并便利对任何末端错位的纠正。 In one embodiment, the catheter placement system using at least two ways for improving catheter placement accuracy: 1) ultrasound-assisted guidance for introducing the catheter into the patient's vasculature; and 2) a tip location / guide system ( "TLS"), or magnetically-based tracking of the catheter tip, to detect and to facilitate advancing the process in such a misalignment correction of any terminal in the catheter through a curved path of the vasculature to promote the process. 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。 According to one embodiment, ultrasound guidance and positioning of the end features of the present system are integrated into a single device, using the clinician for catheter placement. 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。 Both ways are integrated into a single device simplifies the process of catheter placement, and resulting relatively faster catheter placement. 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。 For example, the integrated catheter placement system enables ultrasound and TLS activities can be viewed from a single display to the integrated system. 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。 Further, the integrated device located ultrasound probe (the probe is held within the sterile field of the patient during placement of catheter) the control means can be used to control the function of the system, thereby eliminating a clinician to control the sterile field to the system needs.

[0082] 在另一实施方案中,第三种方式,S卩,基于ECG信号的导管末端引导被包括在所述集成系统中,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。 [0082] In another embodiment, the third embodiment, S Jie, ECG signal-based catheter tip guidance is included in the integrated system to the guide catheter tip is able to produce a relative to the patient's ECG signal the desired location of the heart junction. 本文也将这样的基于ECG的安置辅助称为“末端确认”。 Such paper also ECG-based assist placement referred to as "tip confirmation."

[0083] 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。 [0083] According to one embodiment, a combination of the three above-described manner so that the catheter placement system can facilitate catheter placement accuracy at a relatively high level in a patient's vasculature, i.e. the distal tip of the catheter determined and pre-positioned in a desired position. 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。 Further, since the guide catheter tip based on the ECG, correct placement of the tip can be confirmed without play the role of X-rays was confirmed. 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(reposit1n)过程等等。 This in turn reduces the potential harm to the patient by X-rays, the patient is sent back to the X-ray department and the cost and time it takes the X-ray department, expensive and inconvenient catheter relocation (reposit1n) process and the like.

[0084]由于基于ECG信号的方式包括对以下内容的需要,即从设置在患者的无菌区域内的导管组件将ECG信号传输到设置在非无菌区域内的系统的数据接收部件,本发明的实施方案进一步涉及用于通过使所述无菌区域和非无菌区域分离的无菌屏障建立导电通路的各种连接器系统。 [0084] Since the embodiment based on the ECG signal comprises the following need, i.e., from the catheter assembly is disposed within the sterile field of the patient's ECG signal transmitting means to data receiving system in the non-sterile field, the present invention the embodiments further relate to a variety of connector systems for establishing a conductive path through the sterile and non-sterile fields in an isolated sterile barrier. 还公开了用于可视化和操控经由本系统所获取的所述ECG信号数据显示的各方面,以及各种ECG传感器结构的多个方面。 Also disclosed visualization and manipulation of various aspects of the ECG signal data acquired via the system display, and a plurality of various aspects of the ECG sensor for structure. 还公开了与留置导管或其他医疗设备的系统的检测有关的不例性图标表征。 Also disclosed exemplary embodiments without characterization icon associated with an indwelling catheter or other medical device system of detection.

[0085] 为清楚起见,将理解到的是,本文所使用的词语“近侧的(proximal) ”涉及相对地更靠近临床医生的方向,而词语“远侧的(distal) ”涉及相对地更远离临床医生的方向。 [0085] For clarity, it will be understood that, as used herein, the phrase "(proximal) proximal" refers to a direction relatively closer to a clinician, while the term "distal (distal)" refers to relatively more away from the clinician. 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。 For example, a catheter is placed in the patient is considered to be the end of the distal end of the catheter, and the catheter end remaining outside the body to the proximal end of the catheter. 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。 Also, the words used (including the claims) used herein "comprising (including) ,,," have (has) "and" having (HAVING) ", it shall have the same word" comprising (comprising,) 'the same meaning.

[0086] 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。 [0086] Referring initially depicts a catheter placement system of the present invention, the configuration of the exemplary embodiment of FIG various components ( "system") 1 and 2, the system is generally designated at 10. 如所示的,系统10 —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。 As shown, the system 10 - camel console 20 includes a display 30, probe 40 and sensor 50, each of which will be described in further detail below.

[0087] 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。 [0087] Figure 2 shows 70, 73 in the course of the catheter 72 into the vasculature of a patient through the skin insertion site, the general relationship of these components relative to the patient. 图2示出导管72 —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。 FIG 2 shows the catheter 72-- camel comprising a proximal portion remaining outside of the patient 74 and distal left in the patient vasculature after placement portion 76 is completed. 系统10被用来将导管72的远侧末端76A最终安置(posit1n)在患者脉管系统中的期望位置。 The system 10 is used to the distal end of catheter 72 is disposed 76A final (posit1n) a desired position in the patient's vasculature. 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。 In one embodiment, the distal tip of the catheter 76A, the desired location is adjacent to the patient's heart, for example, in the superior vena cava ( "SVC") under the third (1/3) the inner portion. 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。 Of course, the system 10 may be used to place the catheter distal tip in another position. 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。 74 further comprises a proximal portion of the catheter hub (hub) 74A, a hub 74A of the catheter 72 or more lumens and fluid communication between the hub 74B extending proximally from one or more extension legs.

[0088] 控制台20的示例性实施方式被示于图SC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。 [0088] Console 20 in the exemplary embodiment is shown in FIGS. SC, however, be appreciated that the console in a variety of forms may be employed. 包括非易失性存储器(例如EEPR0M)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。 Includes a nonvolatile memory (e.g. EEPR0M) is included in the processor 22 in console 20, for the role of function of the system during operation of system 10 is controlled, so that the control functions of the processor. 与控制台20 —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)。 And console 20-- onwards, further comprising a digital controller / analog interface 24 and the digital controller / analog interface 24 while the processor 22 and other components of the communication system, to control the detector 40, sensors 50 and other system components interfacing between (interfacing).

[0089] 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。 [0089] The system 10 further includes a sensor 50 and a port 52 connected to optional member 54, including a printer, storage media, such as a keyboard. 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。 In one embodiment the port is a USB port, although other types of ports or port type combinations may be used to connect the ports and other interfaces described herein. 与控制台20—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。 From console 20, including power connection means 56, 58 to enable connection of the external power supply device is operable. 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。 Using the internal battery 60 may be used with an external power supply or internal battery 60 alone. 与所述控制台20的数字控制器/模拟界面24 —起,包括有电源管理电路59,以调节电源的使用及分配。 The console controller 20 and the digital / analog interface 24-- from, including a power management circuit 59, and used to regulate power allocation.

[0090] 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。 [0090] In the present embodiment, the display 30 is integrated into the console 20, and is used in catheter placement procedures to display information to the clinician. 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。 In another embodiment, the display may be separate from the console. 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。 As will be appreciated, the contents of the display 30 according to the described mode the catheter placement system (US, TLS, or ECG to confirm the end of the other embodiments) is changed. 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。 In one embodiment, the console button interface 32 (see FIG. 1,8C) and the buttons included on the detector 40 can be directly used by the clinician to call (call up) to a desired pattern to the display 30, in order to play a supporting role in the placement process. 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。 In one embodiment, for example, in FIG. 17, information from multiple modes (e.g. TLS and ECG) may be displayed simultaneously. 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。 Accordingly, a single system console 30 of the display 20 may be used for ultrasound guidance performed at the time into the patient's vasculature, the TLS guide catheter through the vasculature in the propulsion process, and (as described later in ECG-based acknowledgment scheme) catheter distal tip relative to the patient's heart knot placement. 在一个实施方案中,所述显不器30为一IXD设备。 In one embodiment, the device 30 is not a significant IXD device.

[0091] 图3A和3B根据一个实施方案描绘探测器40的特征。 [0091] Figures 3A and 3B depict features of the detector 40 according to one embodiment. 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。 Probe 40 is to be used with the first embodiment mentioned above, i.e., vessel (e.g., vein) based on ultrasound ( "US") visualization of the catheter 72 is inserted to prepare the vasculature. 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。 Such visualized as the catheter into the patient's vasculature to provide real-time ultrasound guidance, and help reduce complications typically associated with such introduction, including accidental arterial perforation, hematoma, pneumothorax and the like.

[0092] 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纳由患者身体反射后的所述超声脉冲的反射波。 [0092] The hand-held probe 40 includes a receiving head with a piezoelectric array 80, when the head against the skin of the patient in a manner adjacent to the desired insertion site 73 (FIG. 2) is placed, the piezoelectric array with generating ultrasonic pulse and receiving a reflected wave of the ultrasonic pulses reflected by the body of the patient. 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。 Further comprising a detector 40 may be included in the button pad (PAD) 82 on a plurality of control buttons 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。 In the present embodiment of system 10 may be controlled by a control button 84, and thus, the clinician to exclude the sterile region (insertion portion is formed around the patient before the catheter placement) than needed to via the use of the console button interface 32 to change the mode.

[0093] 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。 [0093] Thus, in one embodiment, a clinician using the first (US) to determine the appropriate manner and form a vascular access insertion site, for example, by a needle or introducer device, and then using a catheter. 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。 Then, the clinician may push button via 82 on the probe button pad seamlessly switch to the second (TLS) mode, without having to go outside the sterile field. 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。 Then, the TLS mode may be used to help the catheter 72 through the vasculature advance toward the intended destination.

[0094] 图1示出探测器40还包括按钮和存储控制器42,用来控制按钮和探针的操作。 [0094] Figure 1 shows a probe 40 further includes a button 42 and a memory controller for controlling the operation buttons and the probe. 在一个实施方案中,按钮和存储控制器42可以包括非易失性存储器,例如EEPR0M。 In one embodiment, buttons 42 and a memory controller may include a nonvolatile memory, e.g. EEPR0M. 按钮和存储控制器42与控制台20的探测器接口44是可操作地通信的,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控制器42接口连接的按钮和存储器输入/输出部件44B。 Button 42 and a memory controller interfaces with the detector 44 of the console 20 is in operable communication, a piezoelectric detector includes an input interface 44 connected to the piezoelectric detector array interface / output section 44A, and with and with the button in the memory input / output unit connected to the interface 42 and a memory controller button 44B.

[0095] 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。 [0095] FIG. 4 shows that when the system 10 is in its first mode ultrasound, on the display 30 as depicted in the exemplary screen shot 88. 示出患者70的皮下区域的图像90,描绘静脉92的截面。 90 shows an image of the subcutaneous region of the patient 70, a cross-sectional drawing of the vein 92. 由探测器40的所述压电阵列的操作生成图像90。 Generating an image of the piezoelectric array 90 by the operation of the detector 40. 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。 Also included on the display 88 is a screenshot sounding scale indicator 94, the ratio of the size of the lumen 96 other indicator 98, sounding the depth scale indicator 94 provides information on the patient's skin at about the image 90, and a lumen size ratio 96 provides information on the relative standard catheter lumen size dimensions vein 92, other indicator 98 provides information on the status of the system 10 or actions may be taken, for example, freeze frame, image template, save data, image printing , power status, image brightness and the like.

[0096] 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。 [0096] Note that in other embodiments, when the vein is depicted in the image 90, lumen or other body part can be imaged. 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。 It is noted that, if desired, the US pattern shown in FIG. 4 may be simultaneously shown on a display 30 are depicted with other modes (e.g., the TLS mode). 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。 During catheter placement, in addition to visual display 30, the system 10 may also be employed aural information (e.g., beeps, tones, etc.) to assist the clinician. 另夕卜,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。 Another Bu Xi, including on the detector button 40 and the console button interface 32 may be configured in various ways, including in addition to a slide switch used, for example a button, a switch, or a touch-sensing electronic board or the like user input control means. 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。 Additionally, during use of the system 10, US and TLS activities of both may occur simultaneously or separately.

[0097] 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。 [0097] As just described, handheld ultrasound probe 40 is used as part of an integrated catheter placement system 10, to enable the outer periphery of the patient's vasculature US visualization, the catheter is percutaneously introduced into the preparation. 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。 However, in the present exemplary embodiment, as described below, when the guide catheter in the vasculature towards its desired destination proceeds, the probe is also used to control the system 10 TLS or second functional mode. 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。 Moreover, since the probe 40 is used in the sterile field of the patient, this feature enables complete control of the functions of the TLS from the sterile area. 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。 Thus, the detector 40 is a dual-purpose equipment, from the sterile field for convenient US and TLS control functions of the system 10. 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。 In one embodiment, as will be further described below, the probe can also be used to control associated with the ECG or catheter placement system some or all functions of the third embodiment 10.

[0098] 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。 [0098] The catheter placement system 10 further includes the second embodiment mentioned above, i.e., based on the catheter tip location system TLS or the magnetically. 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。 During the initial advancement into and through the patient's vasculature 70, the TLS enables the clinician to quickly locate and confirm the position of the catheter 72 and / or orientation of the catheter 72, for example, the outer peripheral venipuncture central venous catheters ( "PICC"), central venous catheters ( "CVC"), or other suitable conduit. 具体地,所述TLS方式检测由装配有磁性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。 Specifically, the TLS mode is detected by the probe tip location equipped with a magnetic excitation of the magnetic element, in one embodiment, the probe tip location is preloaded into the lumen defined by a longitudinal manner in the conduit 72 so that the clinician to determine the general location and orientation of the catheter tip within the patient's body. 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。 In one embodiment, one can use the following U.S. patents or more of the teachings of the magnetic assembly track: 5, 775,332; 5,879,297; 6,129,668; 6,216 , 028 and 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。 Entirety herein by reference in the aforementioned U.S. patents are incorporated herein. 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。 The TLS also shows the catheter tip direction pointed to further aid in accurate placement of the catheter. 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。 The TLS further assist the clinician in determining the misalignment occurring when the catheter tip is, for example, the terminal has deviated from the desired path into the vein of another case when the vein.

[0099] 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。 [0099] As mentioned, the TLS using a probe to the distal end of the catheter 72 can be tracked in its passage through the vasculature to promote the process. 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。 Figure 5 shows a probe 100 in such an embodiment, the probe 100 includes a proximal end 100A and a distal end 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。 The proximal end of the probe includes a handle 100A, and a core wire 104 extending distally from the handle. 磁组件被设置在芯线104远侧。 Magnet assembly is disposed distally of the core wire 104. 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封装的磁性元件106。 Said magnet assembly comprises one or more proximate the stylet distal end 100B are arranged adjacent to each other and the magnetic element 108 encapsulated by the pipe 106. 在本实施方案中,包括有多个磁性元件106,每一个元件包括与其他磁性元件以端对端的方式堆叠的固体圆柱状铁磁体。 In the present embodiment, it comprises a plurality of magnetic elements 106, each element comprises a magnetic element with other stacked end to end of the solid cylindrical ferromagnetic. 粘合剂末端110可以在磁性元件106远侧塞堵管108的所述远侧末端。 Adhesive end plugs 110 may be the distal end of the tube 108 in the magnetic element 106 distally.

[0100] 请注意的是,在其他实施方案中,所述磁性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。 [0100] Note that in other embodiments, the magnetic elements in not only shape, the design in terms of composition, number, size, magnetic type, and position in the distal segment of the probe you can also vary. 例如,在一个实施方案中,所述多个铁磁性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。 For example, in one embodiment, the plurality of ferromagnetic elements is replaced by an electromagnetic assembly, for example, a magnetic field generating electromagnetic coil is detected by the sensor. 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(Medical Instrument Locat1n Means) ” 的美国专利N0.5,099,845 中得到,本文通过引用将其全部内容并入本申请。 In another embodiment of this embodiment of the available components may U.S. Patent N0.5,099,845 "medical device positioning means (Medical Instrument Locat1n Means)" is obtained from the subject, herein by reference in its entirety is incorporated herein . 此外,包括可以与所述TSL方式一起使用的磁性元件的探针的其他实施例可以在题目为“探针仪器及制造方法(Stylet Apparatuses and Methods ofManufacture) ”的美国公开号2007/0049846中得到,本文通过引用将其全部内容并入本申请。 Further, a probe comprising a magnetic element that can be used with another embodiment of the TSL embodiments may entitled "apparatus and method for manufacturing a probe (Stylet Apparatuses and Methods ofManufacture)" U.S. Publication No. 2007/0049846 resulting in herein by reference in its entirety is incorporated herein. 因此,本发明的实施方案意图包括这些和其他变体。 Thus, embodiments of the present invention is intended to include these and other variations. 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。 It should be understood here as a "probe (stylet)" as used herein, may be configured to include a removable manner to facilitate placement of the distal end of the catheter in the lumen of the catheter placement any of a variety of devices desired location in a patient's vasculature.

[0101] 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。 [0101] FIG. 2 shows a case where the probe 100 is provided, the probe 100 is substantially in the lumen of the catheter 72, the proximal portion such that the probe 100 extends proximally from the catheter lumen, through a hub 74A and 74B extending through the selected extension legs. 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所进行的相对应的探测指示所述导管远侧端的位置。 Thus disposed in the lumen of the catheter, the distal end of the probe 100 with the distal end of the conduit 100B 76A is substantially co-terminal, corresponding to that performed by the probe distal end of the TLS detecting a position indicative of the catheter distal end.

[0102] 在TLS操作期间,系统10采用TLS传感器50以检测由探针100的磁性元件106产生的磁场。 [0102] TLS during operation, the system 10 uses the TLS sensor 50 to detect the magnetic field generated by the magnetic element 100 in the probe 106. 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。 As shown in FIG. 2, during catheter insertion, the TLS sensor 50 is placed in the patient's chest. 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中的探针磁性元件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。 The TlS sensor 50 placed in the patient's chest predetermined position (e.g., through the use of an external body markers (Landmark)), so that the probe can be a magnetic element as described above is provided in field 106 of the catheter 72, to make the during the passage of the catheter through which the patient's vasculature is detected. 再者,因为探针磁组件的磁性元件106与导管72的远侧端76A(图2)是共端头的,由TLS传感器50所进行的所述磁性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。 Moreover, since the magnetic element stylet magnetic assembly 106 and the distal end 76A of the catheter 72 (FIG. 2) is co-terminal, the magnetic field detecting element is performed by the TLS sensor 50 provide information to the clinician the position information and the catheter distal end during its passage oriented.

[0103] 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。 [0103] More specifically, as shown, the TLS sensor 50 is connected to the console 20 of the system 10 via a port 52 in one or more operable. 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。 Please note that may be used without limitation other TLS connection scheme between the sensor and the system console. 正如所描述的,磁性元件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。 As described, the magnetic element 106 is used in the probe 100 such that the distal end 76A of the catheter (FIG. 2) is placed in a position opposing the TLS sensor 50 of the patient's chest to be observable. 在TLS模式期间,由TLS传感器50所进行的探针磁性元件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。 During the TLS mode, the probe detecting the magnetic element sensor 50 of the TLS 106 to be graphically displayed on the display 30 of console 20. 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。 In this manner, the catheter is placed substantially the clinician to determine the position of the catheter distal end relative to the TLS sensor 50 76A in a patient vasculature, and detect when catheter malposition (e.g., the catheter along an undesired vein, performed promotion) is when occurred.

[0104] 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所进行的探针磁性元件106检测。 [0104] FIGS. 6 and 7A-7E illustrate an embodiment of an icon, the icon display console 30 may be used to depict the magnetic element is detected by the probe sensor 50 of the TLS 106. 特殊地,图6示出当所述磁性元件被安置在所述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所检测的磁性元件106)的图标114。 Particularly, FIG. 6 shows that when the magnetic element is positioned under the TLS sensor, depicting the distal portion of the probe 100 (including the magnetic element 50 are detected by the TLS sensor 106) icon 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。 Because the distal end of the stylet distal end 100B of catheter 72 and 76A are substantially co-terminal, the icon indicates the position and orientation of the catheter distal end. 图7A-7E示出当探针100的磁性元件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。 Figures 7A-7E shows the magnetic element 100 when the probe 106 is not positioned immediately below the TLS sensor 50 (but can still be detected in the vicinity), the icons can be depicted on the console display 30 . 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,磁性元件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。 The icon to the position of the probe comprising a magnet assembly (i.e., in the present embodiment, the relative positions of the magnetic element 106 of the TLS sensor 50) and the half-icons 114A and quarter displayed icons 114B.

[0105] 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。 [0105] FIGS. 8A-8C depict screenshots from display 30 of system 10 is the TLS mode, the probe is shown how the magnetic assembly 100 is described. 图8A的屏幕截图118示出TLS传感器50的表征性图像120。 Screenshot 118 shown in FIG. 8A representational image 120 TLS sensor 50. 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。 Additional information is provided on a display screen shot 118 includes sounding a scale indicator 124, the status / operation indicator 126 is included and a button 20 on the console interface 32 (FIG. 8C) corresponding to icon 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。 Although in this embodiment, the icon 128 is a simple indicator to guide the user identification buttons corresponding to button interface 32 uses, in another embodiment, the touch sensing display may be made to the formula, whereby the icon itself can function button interface and may vary according to the mode of the system is located.

[0106] 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。 The distal [0106] During the initial stage after the catheter inserted into the patient's vasculature to advance through the vasculature, the distal end of probe 100B having substantially co-terminal end 76A of the catheter 72 from the TLS sensor 50 is relatively more Far. 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。 Thus, the display screenshot will prompt "no signal" indicating that the magnetic field from the magnetic assembly of the probe is not detected. 在图SB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。 In FIG. SB, the distal end of the magnetic proximity probe assembly 100B, although it is not immediately below the sensor, it has been advanced sufficiently close to the TLS sensor 50 can be detected. 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。 This is indicated in the left half 114A icon image sensor 120 is shown by characterizing the magnetic assembly from the perspective of the probe of the patient's point of view is disposed on the right side of the TLS sensor 50.

[0107] 在图SC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。 [0107] In FIG. SC, the distal end of the magnetic proximity probe assembly 100B has been in advance under the TLS sensor 50, so that the relative position and orientation can be detected by the TLS sensor. 这由在传感器图像120上的图标114指示。 This is indicated by the icon 114 on the image sensor 120. 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。 Please note that the button icon 128 provides tips can be achieved by pressing the console button interface 32 corresponding button action. 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。 Thus, the button icon 128 may vary depending on the way the system 10 is located so as to provide flexibility using the button interface 32. 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。 Please further note that, since the button panel 40 of the probe 82 (FIGS. 3A, 3B) comprises a plurality of buttons may mimic a button interface 32 in button 84, while maintaining the sterile area to display 30 icon on the button 128 to provide guidance to the clinician using the detector button 84 the control system 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。 For example, if the clinician desires to leave the TLS mode and return US (ultrasound) mode, the appropriate control button 84 on the probe button pad 82 may be pressed, and the US mode can be invoked immediately, while refreshing the display 30 to accommodate US function of the desired visual information, as shown in FIG. 这无需临床医生到所述无菌区域之外即可实现。 This without the clinician outside the sterile field can be realized.

[0108] 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。 [0108] Referring now to FIGS. 9 and 10, according to another exemplary embodiment of the integrated catheter placement system 10 is described. 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。 Supra, e.g., as described above, the integrated system 10 includes a 20, a display console 30, a detector 40 US function, and the TLS sensor 50 for the end of the positioning function. 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。 Note that, in FIGS. 9 and 10 depicted in system 10 in many respects to the system shown in FIG. 1 and 2 are similar. 由此,下面仅对选出的不同之处进行讨论。 Thus, only except the following discussion will be selected. 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。 10 include additional functionality, wherein the catheter distal tip 76A opposing the sinoatrial ( "SA"), or other patient cardiac electrical pulse system 70 of FIGS. 9 and 10 can be emitted to confirm proximity determination junctions, thereby providing enhanced the ability to accurately place the catheter distal tip in a desired position adjacent the junction. 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。 Further, we referred to herein as "ECG" or "ECG-based tip confirmation", the third embodiment of the system 10 to enable the detection of ECG signals from the SA node, to the catheter distal tip in the vasculature system of the patient in a desired location described below. 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,但是可以被一同使用或单独使用来帮助放置导管。 Note that the US, TLS and ECG modalities are seamlessly combined in the present system 10, but may be used together or separately to help position the catheter. 在一个实施方案中,要理解的是如本文所描述的ECG方式可以被包括在独立(stand-alone)系统中而不包括US和TLS方式。 In one embodiment, the ECG is to be understood that the embodiment as described herein may be included in a separate (stand-alone) system does not include US and TLS mode. 因此,本文描述的实施方案所处的环境被理解为仅仅是示例性的环境而不能被认为是对本公开的限制。 Thus, the environment in which embodiments described herein are to be construed as merely illustrative of the environment can not be considered as limiting the present disclosure.

[0109] 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。 [0109] Figures 9 and 10 illustrate additional probe 130 is configured with a system 10 according to this embodiment. 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。 On the whole, to a catheter probe 130 is removably disposed in advance of the catheter 73 is inserted into the patient 70 through the insertion portion 72 of the lumen. 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传感部件(即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,用于探测由所述SA结产生的ECG信号。 Probe 130, in addition to including a magnet assembly based on the TLS mode magnetically outside, near its distal end including a sensing member (i.e., an ECG sensor assembly), and includes co-terminus with the distal end of the catheter tip portion, for detecting ECG signals produced by the SA node. 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。 In contrast to the previous embodiment, probe 130 includes 134, tether 134 is operably connected to the TLS sensor 50 extending from the proximal end of the tether. 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。 As will be further described in detail, as part of the validation process of the ECG signal identification method based on the end position of the catheter tip, the probe 134 allows the tether to be included in a distal portion of the probe 130 the ECG sensor assembly on the detected ECG signal 50 is transmitted to the TLS sensor. 参考和接地ECG芯/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。 Reference and ground ECG lead / electrode pairs 158 is attached to the body of the patient 70 and is operably attached to the TLS sensor 50 to enable the system to filter out the independent electrical activity of the SA node of the heart of a high level electrical activity, thus enabling the ECG-based tip confirmation functionality. 接收自被放置在患者皮肤上的ECG芯/电极对158的参考信号和接地信号,与由所述探针ECG传感器组件探测的所述ECG信号一起被安置在患者胸部的TLS传感器50 (图10)或系统10的其他指定的部件接收。 Received from the patient's skin is placed on the ECG lead / electrode pairs reference and ground signals 158, and the ECG signal from the ECG sensor assembly of the probe detected with the patient's chest is arranged in the TLS sensor 50 (FIG. 10 other specified components) or the receiving system 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。 As will be described, TLS sensor 50 and / or the console processor 22 may process the ECG signal an electrocardiogram waveform data to produce on the display 30. 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。 50 in a case where the processing of the ECG signal data TLS sensor, wherein the processor is included in the function intended to achieve. 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。 If the console 20 processes the ECG signal data, the processor 22, a controller 24 or other processor may be applied in the console to process the data.

[0110] 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。 [0110] Accordingly, as it is advanced through the patient's vasculature, as described above, the probe 130 is fitted with a catheter 72 can be disposed in advance on the patient's chest TLS sensor 50 (FIG. 10) under . 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。 This makes the TLS sensor 50 can detect the position of the probe 130 of the magnetic assembly, said magnetic assembly distal tip 130 of the positioning of the catheter probe within the patient's vasculature 76A is substantially co-terminal of. 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。 During ECG mode, the probe is detected by the magnetic assembly of the TLS sensor 50 is depicted on the display 30. 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。 During ECG mode, the monitor 30 also depicts the results of ECG electrocardiogram waveform patient cardiac electrical activity by the ECG sensor assembly of the stylet 130 of the detected generated. 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。 More specifically, the ECG electrical activity including the SA node P- wave formed by the ECG sensor assembly of the probe (described below) is detected, and the TLS sensor 50 and transmitted to console 20. 然后,所述ECG电活动被处理以在显示器30上进行描述。 Then, the ECG electrical activity to be processed on the display 30 will be described. 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。 Subsequently, a clinician placing the catheter can observe the ECG data to determine the optimal placement of the distal tip 76A of the catheter 72, for example proximate the SA node in one embodiment. 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))。 In one embodiment, console 20 comprising the probe receives and the signal detected by ECG sensor assembly of the necessary electronic components (e.g., processor 22 (FIG. 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。 In another embodiment, TLS sensor 50 may include the necessary electronics process the ECG signal.

[0111] 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。 [0111] As already discussed, during placement of the catheter, the display 30 is used to display information to the clinician. 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。 30 according to the content of the display mode (US, TLS, or ECG) of the catheter placement system is changed. 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。 Now clinician may call any one of three modes to the display 30, and in some cases, information from multiple modes (e.g. TLS and ECG) may be displayed simultaneously. 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。 In one embodiment, and as before, where the mode of the system may comprise a control button 84 on the handheld control of the detector 40, thereby eliminating the clinician to the sterile field (e.g., touch 20 console button interface 32) to change the mode need. 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。 Accordingly, in the present embodiment, the detector 40 is also used to control some or all ECG-related functionality of the system 10. 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。 Note that the button interface or other input structures 32 may also be used to control system functions. 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。 Similarly, during catheter placement, in addition to the use of visual display 30, the system may also be employed aural information (e.g., beeps, tones, etc.) to assist the clinician.

[0112] 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。 [0112] Referring now to FIG 11-12E, describes various details of one embodiment of the probe 130, the probe 130 is removably loaded into the catheter 72 and is used to insert the catheter during distal tip 76A is disposed in the patient vasculature desired position. 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。 As shown, when removed from the catheter, the probe 130 defines a proximal end 130A and a distal end 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。 The connector 132 is included at the proximal end of the probe 130A, and the tether 134 extends distally and attached to the handle 136 from the connector. 芯线138从手柄136向远侧延伸。 The core wire 138 extends distally from the handle 136. 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。 In one embodiment, the probe 130 is preloaded into the lumen of the catheter 72, such that the distal end of the catheter distal end 130B at 76A (FIG. 10) and the conduit opening is substantially flush or co the proximal portion of the tip, and that the core wire 138, a handle 136 and tether 134 extends from the selected one of the tube 74B extends proximally. 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。 It is noted that, although described herein to a probe, in other embodiments, the guide catheter guidewire or other device may be included in embodiments of the principles described herein.

[0113] 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”))。 [0113] core 138 defines an elongated shape and is made of suitable probe materials, including stainless steel or a memory material, for example, in one embodiment an alloy (commonly known abbreviations embodiment comprises nickel and titanium is nitinol ( "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。 Although not shown herein, in one embodiment, the core wire 138 is manufactured from Nitinol the distal segment of the core wire and the portion of the probe can have a corresponding curved configuration preformed , thereby causing the distal portion of the catheter 72 is formed similar to a curved configuration. 在其他实施方案中,所述芯线不包含预成形。 In other embodiments, the core wire does not comprise preformed. 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。 Further, the nitinol wire torsional reinforcement structure 138, such that when the catheter is disposed in the lumen 72 of the distal segment of the probe 130 to be manipulated, which in turn causes the conduit the distal portion of the catheter during the insertion can be guided through the vasculature.

[0114] 提供手柄136来使能所述探针对导管72的插入/移除。 [0114] 136 provides a handle to enable the probe to the catheter 72 is inserted / removed. 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。 In an embodiment the probe is twistable wire 138, the handle 136 further causes the core can be rotated in the lumen of the catheter 72, to assist in guiding the catheter through the distal portion of the pulse of the patient 70 tube system.

[0115] 手柄136附接到绳缆134的远侧端。 [0115] a handle 136 attached to the distal end 134 of the tether. 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。 In the present embodiment, tether 134 is a flexible, shielded cable, a tether 134 or more inclusive electrically connected to the core wire 138 (the ECG sensor assembly of functions related to the above), and wire tether connector 132. 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。 Thus, tether 134 provides a conductive path from the distal portion of the core wire 138 via the tether connector 132 to the proximal end 130A of the probe 130. 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。 As will be explained, the tether connector 132 is configured to be operably connected to the TLS sensor 50 on the patient's chest, to help guide the catheter distal tip 76A to a patient in a desired location in the vasculature.

[0116] 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。 [0116] As seen in FIGS. 12B-12D, the distal portion of the core wire 138 from the junction 142 is distally tapered or reduced in diameter. 套管140在所述减少直径的芯线部分上滑动。 A sliding sleeve 140 on the reduced diameter core wire portion. 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。 Although this has a relatively large diameter, in another embodiment, the sleeve may be sized to substantially match the diameter of the proximal portion of the core wire of the probe. 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。 Probe 130 further includes a magnet assembly 130B is disposed adjacent the distal end thereof for use during TLS mode. 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性元件144。 A plurality of magnetic elements 144 in the illustrated embodiment, the assembly comprises a magnet disposed between the inner surface of the reduced diameter of the core wire and the outer surface 138 of the sleeve 140 proximate the stylet distal end 130B of . 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。 In the present embodiment, the magnetic assembly 144 includes a probe 100 embodiment 20 to a solid cylindrical shape is similar to Figure 2 stacked end-ferromagnetic. 然而,在其他实施方案中,所述磁性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。 However, in other embodiments, the magnetic element may be in not only shape, but also changes in the composition of the design, number, size, magnetic type, and position of the probes. 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。 For example, in one embodiment, the plurality of magnets of the magnet assembly by a magnetic field generated by a solenoid for the alternative sensor detects TLS. 因此,本发明的实施方案意图包括这些和其他变体。 Thus, embodiments of the present invention is intended to include these and other variations.

[0117] 磁性元件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。 [0117] The magnetic element 144 is used for the distal portion of the probe 130 of the probe relative to the distal end 130B is placed on the patient's chest position of the TLS sensor 50 can be observed. 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被配置来检测磁性元件144的磁场。 As already mentioned, a catheter 72 with the advancing of the probe through the patient's vasculature, the TLS sensor 50 is arranged to detect the magnetic field of the magnetic element 144. 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。 In this way, a clinician placing the catheter 72 can generally determine the position of the catheter distal end 76A within the patient vasculature system and detect when catheter malposition (e.g., advancing the catheter along an undesired vein) occurs is when .

[0118] 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。 [0118] According to one embodiment, the probe 130 further includes the aforementioned ECG sensor assembly. 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。 During insertion, the ECG sensor assembly of the probe disposed within a lumen 130 of the catheter 72 can be used to detect atrial ECG signal from the patient or other cardiac SA node generated, thereby allowing the catheter 72 distal to 76A-side end of the guide to a predetermined position adjacent the patient's heart in the vasculature. 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。 Thus, the ECG sensor assembly aid in the proper placement position confirmation of the catheter distal tip 76A.

[0119] 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。 [0119] In the embodiment illustrated in FIG. 11-12E illustrated, the ECG sensor assembly includes a core wire disposed proximate the stylet distal end 130B of distal portion 138. 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。 138 is a conductive core wire of the ECG signal to be detected and the distal end thereof along the core wire can be transmitted proximally. 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。 Conductive material 146 (e.g., conductive epoxy) filling the sleeve 140 adjacent the distal portion of the distal end of the core wire 138, such that the distal end of the core wire is conductively connected. 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。 This in turn increases the conductive surface of the distal end of the probe 130 and 130B, thereby improving the ability to detect ECG signals.

[0120] 在放置导管之前,探针130被装入导管72的内腔中。 [0120] Prior to placement of the catheter, the probe 130 is loaded into the lumen of the catheter 72. 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。 Please note that the probe by the manufacturer can be preloaded into the catheter lumen 130, or by the clinician prior to insertion of the catheter into said catheter. 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。 Probe 130 is placed in the lumen of the catheter, the stylet distal end 130B such that the catheter 72 distal tip 130 is substantially co-terminal 76A, so that both the probe and the catheter the distal tip is substantially placed in alignment with one another. 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—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。 As already described, the catheter 72 and the probe tip 130 co the magnetic assembly to play such a role and the TLS sensor 50 from the TLS mode, i.e. with the distal tip 76A of the catheter in a patient promoting vasculature conducted to track its location. 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。 Note, however, that it is confirmed that the end of the system 10 in terms of function, the distal end of the probe 130 of the catheter distal end 130B need not be co-terminal 76A. 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。 Instead, only the desired conductive path between the vasculature and the ECG sensor assembly, in which case the core wire 138 is such that the electrical pulse SA node or other node of the patient's heart can be detected . 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。 In one embodiment, the conductive path may include various components, including, saline solution, blood and the like.

[0121] 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。 [0121] In one embodiment, once the catheter 72 has 73 (FIG. 10) is introduced into the patient's vasculature via the insertion site, as the TLS mode already described, to the system 10 toward the catheter adjacent the distal tip 76A may be employed the intended destination of the SA node advancing the catheter distal tip 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。 After the region near the heart, the system 10 may be switched to a mode that the ECG signal from the ECG SA node can be detected. 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。 As with the catheter probe is advanced toward the patient's heart, including the ECG sensor assembly of the conductive core wire distal end 138 and a conductive material 146 is started by the detection circuit of the SA node pulse. 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。 Thus, the ECG sensor assembly of the ECG signal detector functions as an electrode. 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。 An elongated core wire adjacent the core wire distal end 138 by a conductive path of the SA node and the generated electric pulses received by the ECG sensor assembly 134 is transmitted to the tether.

[0122] 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。 [0122] The tether 134 is transmitted to the ECG signal is temporarily placed on the patient's chest, the TLS sensor 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。 Tether 134 is operably connected to the TLS sensor 50 via the tether connector 132 or other suitable connecting role of direct or indirect configuration. 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)。 As described, the ECG signal is then processed and can be depicted on the system display 30 (FIG. 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。 Monitoring the ECG signals received by the TLS sensor 50 is displayed by the display 30 is performed, and enables a clinician to advance with the SA node 76A toward the catheter distal tip, observe and analyze changes in the signal . 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。 When the ECG signals received to match a desired profile (profile), the clinician may determine that the catheter distal tip 76A has reached a desired position with respect to the SA node. 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。 As mentioned, in one embodiment, the desired position is located within the lower one-third (1/3) portion of the SVC.

[0123] 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。 [0123] The ECG sensor assembly and a magnetic assembly may cooperate to assist the clinician in placing a catheter within the vasculature. 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。 In general, the magnetic assembly of the stylet 130 assist the clinician in the total initial vasculature guiding catheter from the insertion start, to the distal end 76A of the catheter 72 is placed within the overall region of the patient's heart. 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。 Then, as the ECG sensor assembly of the probe close to the SA node, by allowing the clinician to observe changes in the ECG signal generated by the heart that occur, the ECG sensor assembly may be used in the SVC in the said catheter distal end 76A is guided to a desired position. 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。 Further, once the observed ECG signal profile suitable clinician can determine both the distal end of the probe 130 and the desired position of the catheter 72 relative to the patient's heart has arrived. 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。 Once the catheter 72 has been positioned as desired, the catheter 72 can be fixed in position, and the probe 130 is removed from the catheter lumen. 在此,请注意的是,所述探针可以包括除本文已经明确描述过的以外的各种结构中的一种。 Here, please note that the probe may comprise one of various structures other than the herein explicitly described in. 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。 In one embodiment, the probe may be directly attached to the console, rather than indirectly attached via the TLS sensor. 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。 In another embodiment, the structure of the probe 130 which can TLS and ECG-related functions may be integrated into the conduit structure itself. 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。 For example, in one embodiment, the magnetic assembly and / or the ECG sensor assembly may be incorporated into the wall of the conduit.

[0124] 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。 [0124] FIGS. 13A-15 according to this embodiment, a description of various details of ECG signal data from the path of the probe on the TLS sensor tether 134 is placed on the chest of the patient 50. 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。 In particular, this embodiment relates to the ECG signal data from the passage around the catheter insertion site 72 and the sterile area 73 (including a probe 130 and tether 134), and a non-sterile field, for example, be disposed thereon the TLS sensor of said patient's chest. 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。 Such passages should not destroy the sterility of the sterile area and damage it. 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。 During insertion of the catheter in the patient 70 is placed on a sterile drape defining most of the sterile area: the area above the sterile drape, and thereunder (not including the insertion site and the immediately surrounding regions) of non-sterile. 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。 As will be seen, the discussion below associated performed with the probe 130 comprises at least a first communication node and associated with the TLS sensor 50 of the second communication node, operatively connected with each other so that the ECG signal data can be transmission between the two.

[0125]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“藍鱼鳍(shark fin) ”的实现方式。 [0125] FIG 13A-15 is depicted in an embodiment, i.e., to solve the problem without affecting the passage from the non-sterile field to the sterile field former sterility ECG signal data, the drawing " through the drape (through-drape) "embodiments, also known as" blue fins (shark fin) "implementation. 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。 Specifically, as described above, FIG. 14A shows the TLS sensor for catheter insertion process is placed on the chest of the patient 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。 152 TLS sensor 50 comprises, disposed in the recess in the bottom of the connector 152A defining a recess 152A of the top surface of the bottom has three electrical contacts 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。 Also in FIGS. 13A-13D shown in the fin connector 156 is sized to be a sliding manner as shown in the bottom of the connector receiving recess 152A 152 illustrated in 14B and 15. 两个ECG芯/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。 Two ECG lead / electrode 158 extending from the fin connector 156 for other suitable outer position is placed on the shoulder and torso or body of the patient. 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。 Drape - through the tether connector 132 is configured to slidably mated to a portion of the fin connector 156, as will be further described in order to achieve the probe 120 from below through the sterile area to the TLS sensor 50 conductive paths.

[0126] 图13A-13D示出鳍状连接器156的其他各方面。 [0126] Figures 13A-13D shows various other aspects of the fin connector 156. 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。 Specifically, the fin connector 156 is sized to define the recess 152A is connected to the bottom of the receiving 152 (FIG. 14B, 15) of the lower cylindrical portion 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。 A tapered surface 164 surrounding the central hole 162 is included at the rear end of the cylindrical portion 166. 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。 The cylindrical portion 166 is sized to receive the tether connector 130 of the probe 132 (FIG. 14C, 15), so as to extend into the tether connector channel 172 (FIG. 15) of the needle 132 by the contact 170 central guide hole, the hole 162 is located just until the fin connector 156, so that the tether connector and the fin connector connected to each other. 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的任一侧上,以与在绳缆连接器132上的相对应的止动件(detent) 173 (图13F)接合,来帮助保持在这两个部件之间的配接(mating)。 The engagement member (as shown in FIGS. 13C and 13D of the engagement member 169) may be included on either side of the fin connector 156 to the corresponding connector 132 on the tether stop ( detent) 173 (FIG. 13F) engages, to help keep the two components between mating (mating). 如果这两个部件之间的脱离是期望的,在握紧或固定鳍状连接器156的同时向绳缆连接器132施加足够的回转拉力,以防止鳍状连接器156从连接器底部152的凹槽152A移除。 If the disengagement between the two members is desirable, or applied at the same time gripping the fin connector 156 is fixed to the tether connector 132 sufficient rotation force to prevent the concave bottom of the fin connector 156 from the connector 152 slot 152A removed.

[0127] 图13D示出鳍状连接器156包括多个电气触头168。 [0127] FIG 13D shows the fin connector 156 includes a plurality of electrical contacts 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芯158中的一个的终端,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。 In the present embodiment, three contacts 168 are in such a form comprises: two each of the electrical contacts connected to a front end of the ECG leads 158, and the rear contacts extending into the shaft bore 162 156 (FIG. 15), the tether connector 132 is electrically connected to the adjacent area, so that when the tether connector 132 of the mating pin contact 170 of the fin connector 170 to pin contact. 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。 A bottom portion of each of the contacts 168 of the fin connector 156 is arranged to electrically connect the TLS sensor connector base a base contacts 154,152 in the corresponding. 在一个实施方案中,每一个触头168的底部分包括保持构件,例如凹进(indentat1n) 168A。 In one embodiment, each of the bottom portion of the contact retaining member 168 comprises, for example, a recess (indentat1n) 168A. 如此的配置以致当鳍状连接器156由TLS传感器连接器底部152接收时,每一个触头168可以柔韧地接合底部触头154中各自的一个,从而每一个底部触头的末端被接收在各自的凹进168A中。 So arranged such that when the fin connector 156 is received by the bottom of the TLS sensor connector 152, each contact 168 can flexibly engage a respective bottom contacts 154 a, so that a bottom end of each contact is received in the respective 168A in recess. 这样的配置提供附加的固定(图15)来帮助防止鳍状连接器156从连接器底部152提早分离。 Such a configuration provides additional fixed (FIG. 15) to help prevent the fin connector 156,152 premature separation of the connector from the bottom. 要注意的是,本文已示出并描述的之外,在底部触头154和鳍状触头168之间还可以包括许多不同的保持构件。 It is noted that, other than described herein have been shown and described, the contact between the bottom fin contacts 154 and 168 may also include a number of different holding member.

[0128] 图13E和13F根据一个实施方案描绘绳缆连接器132的各种细节,包括如上面所描述的绳缆连接器凹槽172、设置在所述凹槽内的针触头170以及用于以可移除的方式接合鳍状连接器156 (图13A-13D)的接合件169的止动件173。 [0128] Figures 13E and 13F depict various details of the tether connector 132 according to one embodiment, comprises a tether connector channel as described above 172, disposed within the recess 170 and the pin contact with to removably engage the fin connector 156 (FIGS. 13A-13D) stopper 173 engaging member 169. 图13E还示出多个作为可以被包括以帮助临床医生握紧绳缆连接器132的结构的实施例的抓握(gripping)件171。 FIG. 13E also illustrates a plurality may be included to assist the clinician in gripping the gripping tether connector (of gripping) of the structural member 171 Example 132.

[0129] 图14B示出用于将上面所描述的部件互相连接的第一连接阶段,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。 [0129] FIG. 14B shows the first member for connection phase described above are connected to each other, wherein said sliding engagement through the fin connector 160 and the lower cylindrical portion 152A of the bottom of the groove the connector, so that the fin connector 156 is removably mated with the TLS sensor connector base 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15)。 The engagement of the connector base contacts 154 and the corresponding fin contacts 168 are electrically connected (FIG. 15).

[0130] 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。 [0130] FIG 14C shows a second connection phase, wherein the sliding engagement between the cylindrical portion 166 through the tether connector channel 172 and the fin connector of the tether connector 132 is removably mated with the fin connector 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。 As best seen in FIG. 15, This engagement pin contact after the tether connector 170 and electrical contacts 168 of the fin connector 156 is connected. 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。 In the present embodiment, the tether connector 132 with respect to the horizontal sliding movement of the fin connector 156 to the connector when the fin is to be slidably mated to the groove bottom sensor connector 152A ( FIG. 14B) is the sliding movement of the engagement in the same direction. 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。 In one embodiment, the probe 130 / tether connector 132 and one or both of the fin connector 156 is disposable. 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。 Also, in one embodiment, the tether connector after said connector has been fin mated to the TLS sensor can be mated to the fin connector, while in another embodiment , the tether connector may be prior to the fin connector is mated to the TLS sensor, surgical drape to be mated to the fin connector.

[0131] 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。 [0131] In the connection scheme illustrated in FIG. 14C, the probe 130,132 via a tether is operably connected to the TLS sensor connector 150, thereby making the ECG sensor assembly of the probe can be transmitted to the ECG signal the TLS sensor. 另外,ECG芯/电极对158被可操作地连接到TLS传感器50。 Further, ECG lead / electrode is operably connected to the TLS sensor 50. 158. 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。 However, in one embodiment, the tether connector 132 is referred to as a first communication node for the stylet 130, while the fin connector 156 is referred to as a second communication node for the TLS sensor 50. 如将会看到的,可以利用各种其他的第一和第二连通节点来使能所述ECG传感器组件和所述TLS传感器或其他系统部件之间的导电通路的建立。 As will be seen, we may utilize a variety of other first and second communication nodes to enable the establishment of a conductive path between the transducer and the ECG sensor assembly of the TLS sensor or other system components.

[0132] 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。 [0132] Note that the connection play a role in a variety of other structures may be used to program and implement operative communication between the probe and the TLS sensor. 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。 For example, the tether connector can be used instead of the contact pin contact sheet to pierce the drape. 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。 Alternatively, the fin connector with the TLS sensor may be integrally formed. 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。 Accordingly, these and other structures are included within the scope of the embodiments of the present invention.

[0133] 如所提到的,布单174通常被放置在患者70之上,并且被用作屏障来将诸如所述布单之上并且邻近插入部位73的区域和部件(包括导管72、探针130以及绳缆134(图10))的患者的无菌区域,从诸如所述布单之下的区域和部件(包括患者的胸部、放置在胸部上的传感器50(图10)以及在此也被称为是非无菌区域的紧紧围绕患者70的区域)的所述无菌区域外的非无菌区域分离。 [0133] As mentioned, the drape 174 generally is placed over the patient 70, and is used as a barrier to the drape over the insertion site and the adjacent region and the member 73 (comprising catheter 72, the probe needle 130 and tether 134 (FIG. 10)) of the sterile field of the patient, such as from the region below the drape and the member (including the patient's chest, placed on the chest of the sensor 50 (FIG. 10) and this separating non-sterile area outside the sterile area immediately surrounding regions of the patient 70) is also called non-sterile area. 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。 Sterile drape as seen in FIG. 15, during placement of the catheter is used to form the sterile field 174 is disposed between the tether connector 132 and interconnecting the fin connector 156. 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。 As described, comprises a tether connector 132 is configured to pierce the drape 174 when the two mating contact member 170 of the pin contact. 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。 The drape such perforations piercing the sterile drape 174 occupied by the pin contact 170 is formed in the perforations or holes 175, whereby the pin contact is formed by minimizing the size. 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。 Further, the fit between the tether connector 132 and fin connector 156 is such that the perforations in the sterile drape is formed by passing through the pin contact 170 is surrounded by a tether connector channel 172 the, thus maintaining sterility of the drape and prevents the sterile drape in a region of the gap thus formed may damage. 绳缆连接器凹槽172被这样成形并配置,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,并且以致所述布单在所述凹槽内不会打裙(bunch up)。 The tether connector channel 172 is shaped and configured to pierce the needle 170 prior to the contact being sterile drape 174 is folded down so that the needle contacts being disposed adjacent to the fin connector 156 before hole 162 without piercing the drape and the drape such that the groove does not play within the skirt (bunch up). 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,S卩,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。 Here, please note that the tether connector 132 and fin connector 156 is configured such that, in order to facilitate a sterile drape therebetween opaque to invisible mode (blindly) aligned by 174, S Jie, clinician via palpation of the two components is carried out without visible.

[0134] 如已经提到的,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包括被配置来以这样的方式配接传感器底部触头154的凹进168A,即帮助保持所述鳍状连接器与传感器底部凹槽152A的接合。 [0134] As already mentioned, please further noted that, in FIG. 15 as the fin connector illustrated fin 168 includes contacts 156 are configured in such a manner as to contact with the bottom of the contact sensor 154 recesses 168A, i.e., to help the joint connector 152A to the bottom of the recess of the sensor holder fin. 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。 This in turn reduces the demand for the fin connector 156 is fixed to the additional instrument TLS sensor 50. 在其他实施方案中,与所述电气触头分离的保持构件可以用来帮助保持所述鳍状连接器和所述传感器底部凹槽的接合。 In other embodiments, the isolated electrical contact with the holding member can be used to help engage the connector and the bottom of the groove holding the sensor fin. 在一个实施方案中,底部触头154可以被配置为弹簧针(pogo pins),从而底部触头为垂直地可移动的(displaceable)以帮助保持鳍状连接器156。 In one embodiment, bottom contact 154 may be configured as a spring pin (pogo pins), so as to contact the bottom of a vertically movable (displaceable) to help maintain the fin connector 156.

[0135] 图16示出包括P-波和QRS波群的患者的典型ECG波形176。 [0135] FIG. 16 shows a typical ECG waveform 176 includes a patient P- wave and the QRS complex. 并且对于本系统10来说,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P-波的所述SA结的距离而变化。 For the present system 10 and is, in general, the amplitude of the P- wave generating distance from the SA node P- wave waveform 176 based on the ECG sensor assembly varies. 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。 Clinician may use this relationship in determining when the catheter tip is properly positioned adjacent the heart. 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。 For example, in one embodiment, as has been discussed, the catheter tip is positioned within the lower one-third (1/3) of the vena cava in a desired manner. 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。 The ECG data by the ECG sensor assembly of the stylet 130 is used to detect the reproduction waveform (e.g., waveform 176), described for the system 10 on the display 30 during ECG mode.

[0136] 现在参考图17,根据一个实施方案,描述当系统10在ECG模式(在上面另外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。 [0136] Referring now to Figure 17, according to one embodiment, when the description, aspects of the display on the display 30 of the ECG signal data mode when the ECG system 10 (described further above, the third embodiment). 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,所述表征图像120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。 Display screenshot 178 includes a plurality of elements 30 of the TLS mode, comprising a representation of the image 120 of the TLS sensor 50, the representation of the image 120 having the distal during passage through the patient vasculature corresponding probe 130 icon 114 end position. 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。 Screenshot 178 also includes a window 180, captured by the ECG sensor assembly of the stylet 130 processed by the system 10 is displayed in the current ECG waveform window 180. 随着新波形被检测到,窗口180不断地被刷新。 As new waveforms are detected, the window 180 is constantly refreshed.

[0137] 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。 [0137] Window 182 includes a continuous depiction of the most recently detected ECG waveforms performed, and includes a refresh bar 182A, as the waveform is detected, the refresh 182A laterally moving article to refresh the waveform. 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。 Window 184A is used to display in the ECG sensor assembly is placed in proximity with the SA node of the previously captured baseline ECG waveform, for comparison purposes is to assist the clinician in determining when the arrival the desired catheter tip location. 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。 When the user presses a button on the detector 40 or the console interface 32 to the predetermined button, a window 184B and 184C may be presented ECG waveforms detected by the selected user. 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。 The waveform 184B and 184C of the window is retained until a new waveform by the selection performed by the user pressing a button or by using other input devices caused covered. 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。 As in the previous mode, sounding the scale 124, status / action indicator 126, and button icons 128 are included on the display 30. 完整性指示器186也被包括在显示器30上,来给出所述ECG芯/电极对158是否被可操作地连接到TLS传感器50和患者70的提示。 Integrity indicator 186 is also included on the display 30, to give the ECG lead / electrode pairs 158 are operably connected to whether the TLS sensor 50 and the tips 70 of the patient.

[0138] 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。 [0138] Thus, as seen above, in one embodiment the display 30 is depicted on a single screen simultaneously both the elements of the TLS and ECG modalities manner, thus providing a wealth of data to assist the clinician catheter distal tip in a desired position. 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。 Please further note that, in one embodiment, the printout of a screenshot or ECG or TLS the selected data can be saved, printed, or to be able to retain proper placement of the catheter file recorded by the system 10.

[0139] 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。 [0139] While the embodiments described herein particularly relates to a catheter structure such as PICC or CVC, such embodiments are merely exemplary. 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。 Accordingly, the principles of the present invention may be extended to a number of different structure and design of the catheter.

[0140] 图18-19B描绘用于绳缆连接器132和鳍状连接器156的触头接合结构的实施例。 [0140] FIGS. 18-19B depict an embodiment of the contact structure engaging the tether connector 132 and fin connector 156. 具体地,图18根据一个实施方案描绘鳍状连接器156的鳍状触头168,其中所述后面的触头包括弹簧夹结构168B,用来经由被限定在所述鳍状连接器中的中心锥面164或其他孔接收绳缆连接器132的针触头170 (图15)。 In particular, FIG 18 depicts the fin contacts 168 of the fin connector 156 according to one embodiment, wherein the back contact comprises a spring clip structure 168B, used is defined by the fin connector center 164 or other tapered hole for receiving the tether connector pin contact 170 (FIG. 15) 132. 图19A和19B根据另一实施方案描绘接合方案,其中绳缆连接器132的针触头170包括尖头件(barbed feature) 170A,尖头件170A当被插入鳍状连接器156的中心锥面164或其他孔时接合被限定在所述鳍状连接器的后面的鳍状触头168上的肩168C,以帮助防止所述针触头从所述鳍状连接器提早移除。 19A and 19B depict bonding scheme according to another embodiment, wherein the tether connector 132 includes a tip 170 of the pin contact member (barbed feature) 170A, 170A tip member when inserted into the center of the tapered surface of the fin connector 156 or other engaging hole 164 is defined on a shoulder of the fin 168C in the rear of the connector contacts 168 of the fin to help prevent premature contact of the needle is removed from the fin connector. 因此,这些实施方案用作可以与鳍状连接器156、传感器连接器底部152以及绳缆连接器132 —起被包括的各种触头结构的非限制性实施例。 Accordingly, these embodiments can be used as the fin connector 156, connector 152 and a bottom sensor tether connector 132-- since non-limiting examples of various contact structures are included. 注意的是,除非另行限定,本文所描述的所述触头被理解为包括在建立导电通路中使用的电气触头。 Note that, unless otherwise defined, the contacts described herein are understood to include the establishment of electrical contacts used in the conductive path.

[0141] 下面结合附图20A-32要被描述的实施方案中的每一个将示例性连接方案描绘为这样的装置,即用来在患者的无菌区域和非无菌区域(即所述无菌区域外的区域)之间建立导电或其他连通通路的装置。 [0141] Such a device is depicted below in conjunction with the accompanying drawings 20A-32 connected to each of the exemplary embodiments to be described embodiment in that used in sterile and non-sterile field of the patient (i.e., without the a conductive or other communication pathway established between the device region outside the region bacteria). 因此,本文所描述的实施方案用作对应于用来建立导电或其他连通通路的装置的结构、材料和/或组成的实施例。 Thus, embodiments described herein as corresponding to the structure used to establish a conductive path or other communication devices, materials and / or composition embodiments. 特别地,本文所描述的各种实施方案公开用来穿过或是绕开将所述无菌区域与所述非无菌区域分离的无菌屏障的实施例,以提供用于从传感部件(例如探针130的所述ECG传感器组件)到传感器50 (在本文中也被称为TLS传感器或胸部传感器)或者系统10的其他适合的数据接收部件的ECG信号传送的导电通路的至少一部分。 In particular, various embodiments described herein for delivery through or bypassing the disclosed embodiment the non-sterile field to the sterile field with sterile barrier separating, from the sensing means to provide for (e.g., the ECG sensor assembly of the probe 130) to the sensor 50 (also referred to herein as the TLS sensor or chest sensor) or at least a portion of the conductive path ECG signal transmission system other suitable data receiving section 10. 注意的是,这些实施方案仅仅为用来建立这样的导电或连通通路的各种装置的实施例,而不能被认为是对本公开的范围的限制。 Note that these embodiments are merely examples of such embodiments establish a conductive path or a variety of communication devices is used, not to be considered as limiting the scope of the present disclosure. 因此,要理解的是,用来建立导电或其他连通通路的装置可以被用来传输ECG信号或其他信息、电信号、光信号等。 Therefore to be understood that other means for establishing a conductive or communication path may be used to transmit ECG signals or other information, electrical, optical and the like.

[0142] 如将会看到的,要被描述的许多实施方案包括在本文中也被称为第一连通节点的绳缆连接器,该第一连通节点可操作地连接到探针130并且被包括在所述无菌区域中,所述绳缆连接器被配置来可操作地附接到被包括在传感器50或系统10的其他适合的部件上的连接器,该传感器或连接器在本文中也被称为第二连通节点,该第二连通节点被设置在所述无菌区域外。 [0142] As will be seen, many embodiments to be described herein includes a tether connector is also referred to a first communication node, the first communication node 130 is operably connected to the probe and is included in the sterile field, the tether connector is configured to be operably attached to include a connector on another suitable part of the sensor 50 or the system 10, the sensor or the connector herein also referred to as a second communication node, the second communication node is arranged outside the sterile area. 然而要注意的是,第一连通节点和第二连通节点一般地被意图为涉及各种连接器接口,所述连接器接口提供如上面所描述的从所述无菌区域到所述非无菌区域的导电通路,以使能ECG信号的传送。 Note, however, that the first communication node and the second node communication is generally intended to be directed to a variety of connector interface, the connector interface provided as described above from the sterile area to the non sterile conductive path region, so that the transfer can ECG signals. 要理解的是,所述导电通路为连通通路并且包括电通路、光通路等。 It is to be understood that the conductive path is a communication path and includes an electrical path, the optical path and the like. 另外,在此所描述并考虑的连通节点连接方案可以与这样的系统一起被利用,即包括除ECG信号外的其他方式的使用的系统,用于导管或其他医疗设备的导引或放置。 Furthermore, herein described and considered node communication connection schemes may be utilized in conjunction with such a system, i.e. a system comprising another embodiment of the ECG signal in addition to, or a guide catheter or other medical device is placed.

[0143] 进一步注意到的是,描述用于穿过布单或其他非透明无菌屏障的结构的要遵循的实施方案被这样配置,以致便利临床医生对设置在布单/屏障下面的视线之外的连通节点的位置的触摸,从而方便所述第一和第二连通节点的定位和连接。 [0143] Further is noted that, for description to follow through the drape, or other non-transparent structure is a sterile barrier embodiments are configured such that the clinician to facilitate disposed drape / below the line of sight of the barrier a touch position outside the communication node, so as to facilitate the first and second communication node location and connection. 再有,本文所描述的许多连接器结构可以被配置为一次性使用可抛弃的部件,以使与感染相关的顾虑最小化。 Further, a number of connecting structures described herein may be configured for a single use disposable member, so that the concerns associated with the infection is minimized.

[0144] 现在参考图20A-20C,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0144] Referring now to FIGS. 20A-20C, according to one embodiment is depicted as a connection scheme of such means, i.e., means for establishing a conductive pathway between sterile and non-sterile fields. 具体地,图20A-20C描绘了绳缆连接器232,绳缆连接器232包括外壳体234和附接到所述外壳体的片状刃(blade)支撑器236。 In particular, Figures 20A-20C depict a tether connector 232, the tether connector 232 includes a housing 234 and attached to the sheet-like body housing the blade (Blade) holder 236. 片状刃触头238由片状刃支撑器236固定,以致所述片状刃触头延伸到所述绳缆连接器的凹槽240中。 Blade contact 238 fixed to a sheet blade holder 236, such that the blade contact extending into the recess 240 of the tether connector. 片状刃触头238用来当绳缆连接器232被滑入来以前面实施方案中所描述的方式接合所述鳍状连接器时,在被置于所述绳缆连接器和鳍状连接器256之间的布单中创建划破(slice)穿孔。 To blade contact 238 when the tether connector 232 is slid to the manner previously described embodiments, engage the fin connector, it is disposed in the tether connector and the fin connector drape between 256 to create cut (slice) perforation. 如前面一样的,所述绳缆连接器的外壳体234包住(envelop)并保护所述穿孔,以防止所述无菌区域受到污染和损害。 As before, the housing of the tether connector 234 encasing (envelop) and protect the perforation to prevent the contamination and damage to the sterile field.

[0145] 图20C示出鳍状连接器256包括鳍状触头268,鳍状触头268被配置来当所述绳缆连接器被滑入到鳍状连接器256上时与片状刃触头238实质上互相连接,从而通过所述鞘建立导电通路,以使得来自ECG传感部件(例如即为上面描述的所述ECG传感器组件)的ECG信号能够经由片状刃触头238/鳍状触头268接合传到传感器50。 [0145] FIG 20C shows the fin connector 256 includes contacts fin 268, the fin 268 is configured to contact when the tether connector 256 is a sheet-like blade contact with the fin connector to slide head 238 substantially connected to each other, thus establishing a conductive path through the sheath, so that the ECG signal from the ECG sensor component (e.g., the ECG sensor assembly that is described above) can be 238 / fin blade contact via engaging the contacts 268 passes sensor 50. 注意的是,片状刃和鳍状触头的具体结构可以不同于在此所描述的内容。 Note that the specific configuration of the sheet edge and the fin contacts may be different from the content described herein. 例如,如果期望,绳缆连接器可以包括两个或更多个片状刃或触头,用来与相对应的鳍状触头接合,以使多条导电通路能够被建立。 For example, if desired, the tether connector may include two or more sheet-like or blade contacts for engagement with corresponding fin contacts, so that the plurality of conductive paths can be established. 绳缆连接器和鳍状连接器的接合面也可以不同于所示出并描述的内容。 Tether connector and the fin connector engagement surface may be the content shown and described differs. 在一个实施方案中,光源可以与鳍状连接器或如本文所描述的其他连接器一起被包括,以通过布单174提供照明并且在定位鳍状连接器方面提供视觉辅助,用于与绳缆连接器的互相连接。 In one embodiment, the light source may be included with the fin connector, or other connectors as described herein, to provide illumination through the drape 174 and provides a visual aid in the positioning of the fin connector connection, and for the tether interconnected connector.

[0146] 如在图14A和14B中所见的,在一个实施方案中,ECG芯158被永久地连接到鳍状连接器156。 [0146] As seen in FIGS. 14A and 14B, in one embodiment, the ECG leads 158 are permanently connected to the fin connector 156. 图21A描绘另一可能的实施方案,其中ECG芯经由连接器(例如在图21B中最佳可见的马蹄形连接器270)以可移除的方式被附接到鳍状连接器156。 FIG. 21A depicts another possible embodiment, wherein the ECG leads via a connector (e.g., best seen in FIG. 21B horseshoe shaped connector 270) to be removably attached to the fin connector 156. 图21A还示出鳍状连接器156被永久地附接到传感器50。 FIG. 21A also illustrates the fin connector 156 is permanently attached to the sensor 50. 因此,系统10的各种部件的连接方案中的这些和其他变体被意图为落入本公开的范围。 Thus, the connection scheme of the various components of system 10 in these and other variations are intended to fall within the scope of the present disclosure. 在另一实施方案中,每一个芯的电极是以从所述芯可移除的方式可附接的,例如经由卡扣连接(snap connect1n)。 In another embodiment, the electrodes of each of the core from the core is removably attachable, e.g., via a snap connection (snap connect1n).

[0147] 现在参考图22A-22C,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0147] Referring now to FIGS. 22A-22C, according to one embodiment is depicted as a connection scheme of such means, i.e., means for establishing a conductive pathway between sterile and non-sterile fields. 具体地,图22A-22C描绘包括凹槽372的绳缆连接器332,用来以类似于前面实施方案的方式,可滑动地接合设置在传感器50上的鳍状连接器356的上筒形166。 In particular, FIGS. 22A-22C depict the tether connector channel 372 comprising a 332 to a manner analogous to that previously embodiments, slidably engage the fin connector is provided on the sensor 50 of the upper cylindrical 166356 . 绳缆连接器332包括双向可安置的顶部帽374,针触头370或其他刺穿触头被附接到双向可安置的顶部帽374。 Tether connector 332 includes a bidirectional top cap 374 can be positioned, a pin contact 370 or other piercing contact is attached to a bidirectionally cap 374 disposed at the top.

[0148] 当绳缆连接器332首先被滑入到鳍状连接器356上时,顶部帽374被安置在图22B中虚线所示出的未被致动的第一位置。 [0148] When the tether connector 332 is first slid into the fin connector 356, the top cap 374 is disposed in a first position in broken line shown in FIG 22B is not actuated. 类似于前面的实施方案,布单被置于鳍状连接器356的上筒形166和绳缆连接器凹槽372之间,为清楚起见而被移除。 Similar to the previous embodiments, the drape is placed between the fin connector and a tether connector 166 of the cylindrical recess of 372,356, removed for clarity. 绳缆连接器332被安置在鳍状连接器356上之后,顶部帽374则可以被临床医生按压到图22B中示出的被致动的第二位置,其中针触头370被向下压通过布单并且被压到与设置在鳍状连接器356中的相对应的触头可操作的接合。 After the tether connector 332 is positioned on the fin connector 356, top cap 374 can be pressed into the clinician shown in FIG. 22B a second actuated position, wherein the pin contact 370 is pressed downward by the drape and is pressed to the corresponding contact provided in the fin connector 356 operably engaged. 因而,绳缆连接器332如图22C中所示的被安置。 Thus, the tether connector 332 shown in FIG. 22C is disposed. 除了通过布单174建立导电路径之外,针触头370的这种接合将绳缆连接器332锁合到鳍状连接器356上,以防止所述部件的提早分离。 In addition to establishing a conductive path through the drape 174, the pin contact 370 engages the locking tether connector 332 to the fin connector 356, to prevent premature separation of the member.

[0149] 现在参考图23A和23B,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0149] Referring now to FIGS. 23A and 23B, in accordance with one embodiment of a connection scheme is depicted as an apparatus that is used between sterile and non-sterile fields to establish a conductive pathway. 具体地,图23A描绘包括针触头440或附接到致动组件442的其他适合的触头的绳缆连接器432。 In particular, FIG. 23A depicts a contact 440 comprises a needle attached to an actuator or other suitable assembly 442 contacts the tether connector 432. 致动组件442包括杠杆臂,用来选择性地使针触头440降低而通过由壳体446 (致动组件被设置于壳体446中)的公端头448限定的开口。 The actuation assembly includes a lever arm 442 for selectively lowering the pin contact 440 is defined by the housing 446 (the actuator assembly is disposed in the housing 446) of the male end 448 open. 壳体的公端头448被配置为由设置在传感器50或系统的其他适合的部件(例如可操作地连接到传感器的远程模块)上的传感器连接器插孔(receptacle) 450接收。 The male end of the housing 448 is arranged a sensor head connector jack (receptacle) 450 received by other suitable means (e.g., a sensor operatively connected to the remote module) or the sensor 50 provided on the system.

[0150] 为使绳缆连接器432与传感器连接器插孔450互相连接,在布单174之上绳缆连接器432的公端头448被拿到邻近插孔450的位置。 [0150] In order to tether connector 432 and the connector jack sensors 450 are connected to each other, the male end 174 on the drape 432 of the tether connector 448 is to get a position adjacent to the head 450 of the receptacle. 致动组件442则通过如在图23B中示出的抬高杠杆臂444来致动。 The actuating assembly 442 is actuated through 444 as shown in FIG. 23B elevation lever arm. 针触头440被迫使向下降而通过布单174,从而在其中限定穿孔。 Pin contact 440 is forced to fall through the drape 174, thus defining a perforation therein. 然后,公端头448可以被完全接收到传感器插孔450中,其中针触头440可操作地与传感器连接器插孔的适合的触头连接。 Then, the male end 448 may be completely received into the sensor insertion hole 450, the pin contact 440 which is operably connected to the sensor jack connected to suitable contacts. 图23A和23B中示出的连接器方案对于连接器互相连接期间在患者身体上施加最小向下的力是有用的。 23A and 23B forces illustrated embodiment is applied to a connector on the body downward a minimum for the patient during each connector is useful. 另外,致动组件442在使第一连通节点(绳缆连接器432)与第二连通节点(传感器连接器插孔450)连接过程中提供预先确定的力,并且从而不依赖于临床医生对建立节点连接的用力的估量。 Further, the actuator assembly 442 when the first communication node (the tether connector 432) and provides a predetermined force (the sensor connector receptacle 450) a second communication node connection process, and thus is not dependent on the clinician to establish forced to estimate nodes. 在另一实施方案中,致动组件442被致动来使触头440刺穿通过布单之前,壳体446和传感器插孔450可以被对准并配接。 In another embodiment, the actuator assembly 442 is actuated to cause the contact 440 to pierce through the drape prior to the housing 446 and the sensor receptacle 450 may be aligned and mated.

[0151] 现在参考图24,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0151] Referring now to FIG. 24, according to one embodiment is depicted as a connection scheme of such means, i.e. means for establishing a conductive pathway between sterile and non-sterile fields. 如在图23A和23B所示出的实施方案中,节点的互相连接期间,本互相连接方案使患者身体上的向下的压力最小化。 As in the embodiment of FIGS. 23A and 23B shown, the nodes are connected to each other during, the present embodiment connected to each other so that the downward pressure on the body of the patient is minimized. 如所示的,绳缆连接器532包括针触头540或与带螺纹的帽542 —起被包括的其他适合的触头,带螺纹的帽542在其内侧面上限定螺纹。 As shown, the tether connector 532 includes a pin contact 540 or a threaded cap 542-- from other suitable contact is comprised of a threaded cap 542 is threaded on its inner surface is defined. 带螺纹的帽542被配置来以螺接方式接收设置在传感器50或系统的其他适合的部件(例如可操作地连接到传感器的远程模块)上的带螺纹的底部544。 A bottom cap 542 threaded 544 is configured to threadedly disposed on the receiving member other suitable sensors or systems 50 (e.g., the sensor operatively connected to the remote module) is threaded. 如前面一样的,布单174被置于二者之间。 As before, the drape 174 is disposed therebetween.

[0152] 为使绳缆连接器532与传感器50互相连接,在布单174之上绳缆连接器的带螺纹的帽542被拿到邻近带螺纹的底部544的位置并被螺接到所述底部之上。 [0152] In order to tether connector 532 to the sensor 50 is connected to each other, above the drape 174 in threaded cap tether connector 542 to get a position adjacent the bottom of the threaded and is screwed to the 544 above the bottom. 这导致针触头540刺入布单174,从而在其中限定穿孔。 This causes the pin contact 540 penetrating the drape 174, thus defining a perforation therein. 进一步将帽542螺接到底部544之上导致针触头540接合被包括在底部544中的触头插孔546,从而可操作地使所述两个节点互相连接。 The cap 542 screwed further over the bottom lead 544 includes a pin contact 540 is engaged in the bottom of receptacle 544 contacts 546, thereby operatively interconnecting the two nodes. 在一个实施方案中,绳缆134被可旋转地附接到带螺纹的帽542,以防止绳缆在螺接期间的缠绕(twisting)。 In one embodiment, tether 134 is rotatably attached to the threaded cap 542 to prevent the tether is wound during the screwing (twisting). 由于经由螺接操作,用来连接这两个连接器的力相对于患者被横向地引导,图24中示出的连接器方案对于连接器互相连接期间在患者身体上施加最小向下的力是有用的。 Since via screwing operation force for connecting the two connectors relative to the patient to be guided laterally, FIG. 24 shows the scheme for the connector during the connector minimal downward force is applied to each other in the body of a patient is useful. 进一步注意的是,本公开意图包括各种螺接结构和位置以及不同的帽和底的结构。 It is further noted that the present disclosure is intended to include various structures and locations of screwing of the cap and the structure and the different bottom.

[0153] 现在参考图25A和25B,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0153] Referring now to FIGS. 25A and 25B, in accordance with one embodiment of a connection scheme is depicted as an apparatus that is used between sterile and non-sterile fields to establish a conductive pathway. 如在前面的实施方案中,本互相连接方案使在所述节点的互相连接期间患者身体上的向下的压力最小化。 As in the previous embodiment, this embodiment makes interconnected downward pressure on the patient's body during the minimization of the nodes connected to each other. 如在图25A和25B中所描绘的,绳缆连接器632包括一个或更多个刺穿触头,例如分别被包括在滑动臂642A和642B上的针触头640A和640B。 As shown in FIGS. 25A and 25B depicted, the tether connector 632 includes one or more piercing contacts, for example contact 640A comprising a needle are on the slide arms 642A and 642B and 640B. 一个或更多个触头插孔(例如触头插孔644A和644B)被包括在传感器50的一部分(例如传感器鳍646)或其他适合的系统部件上。 One or more receptacle contacts (e.g., contact receptacles 644A and 644B) is included in a part (e.g., the sensor fin 646) on the sensor 50 or other suitable system component. 如前面那样的,布单174被置于绳缆连接器632和传感器鳍646之间,以用作无菌屏障。 As before, the drape 174 is disposed between the tether connector 632 and the sensor fin 646 to act as a sterile barrier.

[0154] 为使绳缆连接器632与传感器鳍646互相连接,在布单174之上绳缆连接器被拿到邻近传感器鳍的位置,从而滑动臂642A和642B跨于传感器鳍而以致如图25A中示出的,针触头640A和640B与相对应的触头插孔644A和644B对准。 [0154] In order to tether connector 632 connected to the sensor fin 646 each other, above the drape 174 to get the tether connector is positioned adjacent the sensor fin to slide arms 642A and 642B so as to straddle the fin sensor in FIG. 25A shows, the needle contacts 640A and 640B are aligned with corresponding contact receptacles 644A and 644B. 然后,滑动臂642A和642B被朝向彼此滑动,以致针触头640A和640B刺入布单174,每个针触头在布单中限定一个穿孔。 Then, the slide arms 642A and 642B are slid toward each other, such that the pin contacts 640A and 640B piercing drape 174, each defining a perforation pin contact drape. 滑动臂642A和642B被向内滑动直到如在图25B中可见的,针触头640A和640B就位于其中并且可操作地与相对应的触头插孔644A和644B连接,从而使这两个节点互相连接。 Slide arms 642A and 642B are slid inwardly until as seen in FIG. 25B, the pin contacts 640A and 640B is located therein and operatively connected to contact receptacles 644A and 644B corresponding to, so these two nodes connected to each other. 由于用来连接这两个连接器的力相对于患者被横向地引导,图25A和25B中示出的连接器方案对于连接器互相连接期间在患者身体上施加最小向下的力是有用的。 Since the force used to connect the two connectors is directed laterally with respect to the patient, in FIGS. 25A and 25B show a connector embodiment minimal downward force exerted on the body of the patient during connector to each other it is useful. 进一步注意的是,绳缆连接器、传感器鳍以及触头的具体结构可以不同于本文所明确描述的内容。 It is further noted that the tether connector, a specific configuration of the fin and a contact sensor may be different from the contents described specifically herein. 例如,在一个实施方案中,滑动臂可以被配置为双向可安置的摇臂,所述摇臂以跷跷板的结构相对于彼此连接。 For example, in one embodiment, the slide arm can be configured to be bidirectional disposed rocker arm in a seesaw configuration with respect to each other. 再者,一个、两个或更多个触头可以被包括在滑动臂上。 Further, one, two or more contacts may be included in the sliding arm.

[0155] 现在参考图26A和26B,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0155] Referring now to FIGS. 26A and 26B, in accordance with one embodiment of a connection scheme is depicted as an apparatus that is used between sterile and non-sterile fields to establish a conductive pathway. 如所示的,集成连接器730被并入到布单174中,以使能穿过其中的可操作的互相连接。 As shown, the integrated connector 730 is incorporated into the drape 174, to enable therethrough operably connected to each other. 在图示说明的实施方案中,集成连接器730包括导电底部部分734,从导电底部部分734延伸机械式连接器,例如卡扣球736A和736B。 In the illustrated embodiment, the integrated connector 730 includes a conductive bottom portion 734, extending from the mechanical connector electrically conductive bottom portion 734, e.g. spiking cards 736A and 736B.

[0156] 如在图26B中示出的,集成连接器730被固定在布单174中,以至于与以下部件均是可连接的,即绳缆连接器732的适合的插孔738和传感器50的适合的插孔740 二者或者是系统10的其他适合的部件。 [0156] As shown in FIG. 26B, the integrated connector 730 is fixed to the drape 174, so that the following members are connectable, i.e. for the tether connector 732 and jack sensors 738 50 suitable both jack 740 or other suitable components of system 10. 具体地,绳缆连接器732可以被卡扣附接到集成连接器730,此后集成连接器可以被附接到传感器50,从而为这样的信号提供适合的通路,即来自无菌区域中的ECG传感器组件、要通过布单174的无菌屏障被传输至非无菌区域中的传感器的信号。 Specifically, the tether connector 732 can be attached to an integrated snap connector 730, after which the integrated connector 50 may be attached to the sensor, thereby providing a suitable path for a signal, i.e., an ECG from a sterile field a sensor assembly, a signal to be transmitted to the non-sterile field sensor by a sterile barrier 174 of the drape. 要理解的是,在其他实施方案中,集成连接器可以包括其他结构,例如不同的机械式连接器,如摩擦连接器、公/母连接器等等,并且这样在绳缆连接器和传感器上的插孔可以同样被修改来适应不同的机械式连接器。 It is to be understood that, in other embodiments, the integrated connector can include other structures, such as different mechanical connectors, friction connectors, male / female connectors, etc., and so the tether connector and sensor jack can also be modified to accommodate different mechanical connectors. 再者,上面描述的连接方案可以为反过来的,从而插孔被包括在集成连接器上而卡扣球被包括在各自的绳缆连接器和传感器上。 Further, the connection scheme described above may be reversed, so that the jack is included on the card and the integrated connector spike was included on a respective tether connector and sensor. 此外,尽管当前是被描绘为单个(unitary)部件,在其他实施方案中集成连接器可以包括两个或更多个部分,这些部分在其制造期间通过前面所限定的布单中的孔而被相互附接。 Further, even though the current is depicted as a single (unitary) member, in other embodiments, the integrated connector may include two or more portions that during its manufacture the front through the aperture defined in the drape is attached to each other. 因此,意图包括这些和其他变体。 Accordingly, it is intended to include these and other variants.

[0157] 现在参考图27,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0157] Referring now to FIG. 27, according to one embodiment is depicted as a connection scheme of such means, i.e., means for establishing a conductive pathway between sterile and non-sterile fields. 具体地,图27描绘设置在患者的无菌区域外的中间模块,即可操作地经由传感器线缆752连接到系统10的传感器50的ECG模块750。 In particular, FIG 27 depicts the intermediate module is provided outside the sterile field of the patient, can be operatively connected to the sensor system 10 of the ECG module 50 via a sensor cable 750 752. ECG模块750还被可操作地连接到ECG芯158。 ECG module 750 is further operatively connected to the ECG leads 158. 在一个实施方案中,ECG模块750包括对由探针130的ECG传感器组件检测到的ECG信号的接收和分析所需要的电路和其他部件。 In one embodiment, ECG module 750 includes a circuit and other components for receiving and analyzing ECG signals detected by the ECG sensor assembly of the stylet 130 need. 这样,探针130和ECG模块750之间的导电通路通过横贯患者的无菌区域来建立。 Thus, the conductive path between the probe 130 and the ECG module 750 to establish the sterile field traverses through the patient. 在本实施方案中,这是通过绳缆134的绳缆连接器762来实现的。 In the present embodiment, this is accomplished by a tether connector 134 of the tether 762.

[0158] 如在图27中所描绘的,绳缆连接器762可操作地附接到ECG模块750的插孔764。 [0158] As depicted in FIG. 27, the tether connector 762 operably attached to the modular jack 764 750 the ECG. 如所示出的,绳缆连接器762可以包括足够长的手柄,所述手柄使临床医生能够将无菌绳缆连接器附接到非无菌ECG模块750的插孔764,而不触碰ECG模块本身,从而防止无菌区域受到任何损害。 As shown, the tether connector 762 can include a sufficient handle that enables a clinician to sterile tether connector is attached to a non-sterile receptacle 764 750 of the ECG module, without touching ECG module itself, thus preventing any damage sterile field. 在一个实施方案中,绳缆连接器762的手柄可以包括例如可延伸的挂钩(J-hook)触头,该挂钩触头可以可操作地连接到ECG模块的适合的触头。 In one embodiment, the tether connector 762 of the handle may include, for example, may be extending hook (J-hook) contacts the hook contacts may be operably connected to a suitable contact ECG module.

[0159] 图27还描绘一可以与本文所描述的任一实施方案一起使用的脚踏开关1116,脚踏开关1116可以被放置在靠近临床医生双脚的地面上,并且被用来在导管放置过程中控制系统功能的选定方面。 [0159] FIG. 27 depicts a further be described herein with any embodiment of a program for use with a foot switch 1116, a foot switch 1116 may be placed on the ground near the feet of a clinician, and is used to place the catheter selected aspects of the process control system functions. 例如,在一个实施方案中,脚踏开关1116可以被用于在系统显示器30上定格ECG波形图像,或者在所述过程中或甚至是在所述过程结束之后创建显示器的打印输出,从而提供最终导管放置的记录。 For example, in one embodiment, the foot switch 1116 may be used to freeze the image on the ECG waveform display system 30, or even to create the print or display output after the end of the process in the process, so as to provide a final catheter placement record. 当然,脚踏开关的设计和功能可以以在本文中被明确示出并描述的许多方式来修改。 Of course, the design and function of a foot switch may be explicitly shown in a number of ways to modify and described herein.

[0160] 图28根据一个实施方案示出作为连接方案的一部分的绳缆连接器的另一实施例,该绳缆连接器可以与图27的ECG模块750或者与系统10的其他适合的部件一起使用,该连接方案被描绘为用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0160] FIG. 28 shows a further embodiment of a tether connector connected to a part of the program in accordance with one embodiment, the tether connector may be appropriate with other components of the ECG module of FIG. 27 or 750 of the system 10 use, the connection scheme is depicted as a means for establishing a conductive pathway between sterile and non-sterile fields. 具体地,图28描绘绳缆连接器832,绳缆连接器832在其近侧端包括手柄和尖触头836或其他适合的触头。 In particular, FIG 28 depicts a tether connector 832, the tether connector 832 includes a handle and a tip contact 836 or other suitable contact at its proximal end. 无菌防护体838被置于手柄834和触头836之间。 Sterile shield 838 is disposed between the handle body 834 and the contact 836. 在以类似于图27所示出的方式将触头836插入ECG模块750的插孔764中时,无菌防护体838帮助保护临床医生的手。 In a manner similar to that shown in FIG. 27 the contact 836 is inserted into receptacle 750 when the ECG module 764, a sterile shield body 838 to help protect the clinician's hand. 因此,无菌防护体838起到附加屏障的作用,来防止临床医生与无菌区域外的部件(例如ECG模块750)意外接触。 Thus, sterile protective member 838 serves as an additional barrier to prevent accidental contact member (e.g., the ECG module 750) and an outer sterile field clinician. 注意的是,无菌防护体和/或其他绳缆连接器的尺寸、形状和具体结构可以不同于在本实施方案中所明确描述的内容。 Note that the size, shape and specific configuration of sterile protection and / or other tether connector may be different from the contents in the present embodiment explicitly described.

[0161] 图29A和29B根据一个实施方案示出连接方案的又另一实施例,该连接方案可以与图27的ECG模块750或者与系统10的其他适合的部件一起使用,该连接方案被描绘为用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0161] FIGS. 29A and 29B show a connection scheme according to one embodiment of yet another embodiment, the connection scheme may be used, or other suitable components of system 10 with the ECG module 750 of FIG. 27 together, the connection scheme is depicted means for establishing a conductive pathway is between sterile and non-sterile fields. 具体地,图29A示出ECG模块750可以被无菌袋850包住。 In particular, FIG. 29A shows the ECG module 750 may be a sterile bag 850 wrap. 连接器(例如上面结合图26A和26B所描述的集成连接器730)可以被并入到所述袋中。 The connector (e.g., an integrated connector in conjunction with FIGS. 26A and 26B above described 730) may be incorporated into the bag. 如在图29B中示出的,集成连接器730的内卡扣球或其他机械式连接器可以被ECG模块750的适合的相对应插孔764接收。 As shown in FIG. 29B, the integrated connector spike card or other mechanical connectors 730 may be adapted corresponding to the ECG module 764 receives receptacle 750. 系统10的绳缆连接器则可以可操作地与集成连接器730的外卡扣球或其他连接器连接,从而在无菌区域和非无菌区域之间建立导电通路而不损害无菌性。 System tether connector 10 can be operatively connected to the integrated external card connector spike or other connectors 730, thus establishing a conductive pathway between sterile and non-sterile field without compromising sterility. 注意的是,无菌袋850可以包括各种适合材料(包括塑料)中的任何一种或更多种。 Note that the sterile bag 850 may include a variety of suitable materials (including plastic) in any one or more thereof. 还要注意的是,除了本文所明确描述的内容集成连接器可以包括其他连接器结构。 Also note that, in addition to the contents described herein are expressly integrated connector may include other connector configurations. 在一个实施方案中,无菌袋不包括集成连接器,而是由绳缆连接器的针触头(例如被包括在图28的绳缆连接器832上的尖触头836)刺穿。 In one embodiment, the sterile bag does not include an integrated connector, but the tether connector pin contact (e.g., contact tip is included on the tether connector 832 of FIG. 28 836) piercing.

[0162] 现在参考图30,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0162] Referring now to FIG. 30, according to one embodiment is depicted as a connection scheme of such means, i.e., means for establishing a conductive pathway between sterile and non-sterile fields. 具体地,如在前面的实施方案中那样,探针130包括作为第一连通节点的绳缆连接器862。 Specifically, as in the previous embodiments above, the probe 130 includes a first communication node, the tether connector 862. 还包括作为第二连通节点的远程传感器连接器864,并且远程传感器连接器864被可操作地经由远程传感器连接器线缆866连接到系统10的传感器50。 Further comprising a remote sensor connector 864 as a second communication node, and the remote sensor connector 864 to the cable 866 is operably connected to the sensor 50 of the system 10 via the remote sensor connector. 绳缆连接器862和远程传感器连接器864可操作地沿连接接口868彼此连接。 The tether connector 862 and remote sensor connector 864 is operatively connected to each other along the connection interface 868. 起到无菌屏障作用的布单174被置于绳缆连接器862和远程传感器连接器864之间的连接接口868,并且适合的布单刺穿结构与绳缆连接器和远程传感器连接器一起被包括,来建立通过布单的导电通路。 Play a role in sterile barrier drape 174 is placed in the tether connector 862 and remote sensor connector 868 is connected between the interface 864 and is adapted to pierce the drape structure and the tether connector and the remote sensor connector together It is included to establish a conductive path through the drape. 因而,本实施方案公开一个这样的实施方案,其中第二连通节点相对于传感器50被远程地定位。 Accordingly, embodiments of the present disclosure one such embodiment, wherein the second communication node with respect to the sensor 50 is located remotely.

[0163] 现在参考图31,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0163] Referring now to FIG. 31, according to one embodiment is depicted as a connection scheme of such means, i.e., means for establishing a conductive pathway between sterile and non-sterile fields. 具体地,如上面结合图30所描述的,本发明包括可操作地沿连接接口868彼此连接的绳缆连接器862和远程传感器连接器864。 Specifically, as described above in connection with FIG. 30, in the present invention includes the connection interface 868 operably connected to each other tether connector 862 and remote sensor connector 864. 本实施方案中的远程传感器连接器864被放置在邻近导管插入部位73的区域中,在该区域之上被限定在布单174(为清楚起见,布单的部分被省略)中的窗孔(fenestrat1n)880被这样安置,来使临床医生在导管放置期间能够接近(access to)插入部位。 The present embodiment of the remote sensor connector 864 is placed in an area adjacent to the catheter insertion portion 73, is defined in the drape 174 (for clarity, the drape portion is omitted) in the region above the aperture ( fenestrat1n) 880 is arranged so to enable the clinician during catheter placement is accessible (access to) the insertion site. 围绕插入部位的区域被消毒以为导管插入做准备之前,在使用粘合剂、胶带等的情况下,远程传感器连接器864被附着到患者的邻近导管插入部位73的皮肤。 Area around the insertion site prior to insertion of the catheter that is sterilized to prepare, in the case of using an adhesive, tape, etc., the remote sensor connector 864 is attached to the catheter adjacent the skin of the patient insertion site 73. 因此,当插入部位被消毒时,远程传感器连接器864也被消毒。 Accordingly, when the insertion site is disinfected, the remote sensor connector 864 is also disinfected. 稍后,当将绳缆连接器862连接到远程传感器连接器864时,临床医生可以握住远程传感器连接器864而不损害患者的无菌区域。 Later, when the tether connector 862 is connected to the remote sensor connector 864, the clinician can grasp the remote sensor connector 864 without compromising the sterile field of the patient. 理解的是,绳缆连接器和远程传感器连接器的具体结构可以变化而仍属于本实施方案的范围内。 It is appreciated that the specific configuration of the tether connector and the remote sensor connector may vary and still fall within the scope of the present embodiment.

[0164] 现在参考图32,根据一个实施方案将连接方案描绘为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路。 [0164] Referring now to FIG. 32, according to one embodiment is depicted as a connection scheme of such means, i.e. for establishing a conductive pathway between sterile and non-sterile fields. 具体地,图32示出针对US功能,系统10所采用的如上面结合图3A和3B所描述的探测器40。 In particular, FIG. 32 shows the function for the US, the probe 40 as described above in conjunction with FIGS. 3A and 3B described system 10 employed. 无菌鞘900被放置在探测器40之上,以使探测器进入患者的无菌区域。 Sterile sheath 900 is placed over the probe 40 to the probe into a sterile field of the patient. 连接接口(例如插孔910)被包括在探测器900上并且被这样配置,以与绳缆连接器920是可操作地可连接器的。 Connection interface (e.g. receptacle 910) is included and is arranged so that on the detector 900, with the tether connector 920 is operably connector. 例如,在一个实施方案中,绳缆连接器920包括刺入无菌鞘900的针触头,来通过这样的方式与插孔910配接以防止无菌区域受到污染。 For example, in one embodiment, the tether connector 920 includes a sterile sheath piercing needle 900 contacts, in such a way to the mating receptacle 910 to prevent contamination of the sterile field. 以这种方式,作为第一连通节点的绳缆连接器920可操作地与作为第二连通节点的探测器40连接。 In this manner, as the tether connector 920 of the first communication node is operable as a detector 40 is connected with a second communication node. 例如在图31中可见的,探测器40又可操作地连接到系统控制台20,以使由探针130的ECG传感器组件经由绳缆连接器920接收的ECG信号能够如上面所描述的那样被传送至控制台、传感器50或者用于进行处理的其他系统部件。 For example visible in FIG. 31, the probe 40 in turn is operatively connected to the system console 20, so that the ECG signal from the ECG sensor assembly of the stylet 130 via the tether connector 920 is received as described above it is possible as is transferred to the console, the sensor 50 or other system components for processing. 在另一实施方案中,插孔910或其他适合的连接接口可以被包括在将探测器40连接到系统控制台20的线缆上。 In another embodiment, the receptacle connector 910 or other suitable interface may be included in the detector 40 is connected to the cable system console 20. 插孔910和绳缆连接器920的具体接触结构可以根据本领域技术人员的理解而变化。 DETAILED socket contact structures 910 and tether connector 920 can vary depending understood by those skilled in the art. 例如,在一个实施方案中,集成连接器(例如图26A和26B中所示出的)可以被并入到无菌鞘中。 For example, in one embodiment, the integrated connector (e.g., shown in FIGS. 26A and 26B shown) may be incorporated into a sterile sheath. 进一步注意的是,尽管在本实施方案中包括塑料,如本文所描述的无菌鞘可以包括其他适合的材料来提供无菌性。 It is further noted that although in the present embodiment comprises a plastic embodiment, the sterile sheath as described herein may comprise other suitable material to provide sterility.

[0165] 现在参考图33,根据一个实施方案描绘用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0165] Referring now to FIG. 33, according to one embodiment is depicted embodiment means for establishing a conductive pathway between sterile and non-sterile fields. 如所示出的,绳缆134包括被包括在无菌区域之中的无线模块950,无线模块950起到第一连通节点的作用,用来以无线的方式(经由RF或其他适合的频率或频率范围)将从探针130的ECG传感器组件接收到的ECG数据传输至作为第二连通节点的数据接收部件,例如传感器50或系统10的其他适合的部件。 The tether 134 shown includes a wireless module included in the sterile field 950, wireless communication module 950 function as a first node, used in a wireless manner (via RF or other suitable frequency or frequency range) from the ECG sensor assembly of the probe 130 of the received ECG data to the data receiving means as a second communication node, such as a sensor system 50 or other suitable member 10. 无线模块接地电极952被可操作地与无线模块950连接,用来在邻近导管插入部位73的无菌区域中放置。 Wireless module ground electrode 952 is operatively connected to the wireless module 950, for placement in the sterile field adjacent the catheter insertion site 73. 系统接地电极158A从传感器50延伸,用来在无菌区域外而邻近导管插入部位73和无线模块接地电极952的位置放置。 The system of the ground electrode 50 extends from the sensor 158A, and used outside the sterile field adjacent the placement position of the catheter insertion site 73 and the wireless module ground electrode 952. 用于系统接地电极158A的一种可能的放置位置为如图33中所描绘的在患者手臂下方。 One possible system for placement of the ground electrode 158A is depicted in FIG. 33 below the patient's arm. 如在前面的实施方案中的,系统参考电极158B被放置在患者70的下躯干或其他适合的位置上。 As in the previous embodiments, the system reference electrode 158B is disposed in the torso or other suitable location on the patient 70. 注意的是,如本文所讨论的无线模块和系统控制台可以以各种方式中的一种或更多种来配置,并且包括在此没有详细描述的用于无线信号传输和接收的部件,例如微带天线(patch)或其他天线、信号变换器等等。 Note that, as discussed herein, a wireless module and a system console may be configured in a variety of ways or more, and comprising means for wireless signal transmission and reception are not described in detail herein, e.g. microstrip antenna (Patch) or other antennas, signal converter and the like.

[0166] 在系统被以如图33中示出的方式配置的情况下,系统接地电极158A可以为电气驱动的,从而其生成由无源无线模块接地电极952探测的电压,给出其相对于系统接地电极的邻近位置。 [0166] In the case where the system is configured in a manner illustrated in FIG. 33, the system ground electrode 158A may be driven by an electrical, thereby detecting the voltage which is generated by the passive wireless module ground electrode 952, with respect to give Nearby system ground electrode. 这使得二接地电极基本上是等电势的,从而使无线模块950能够使用无线模块接地电极952,而ECG信号来自探针130的ECG传感器组件(例如在一个实施方案中的芯线138 (图12C-12E)),来检测ECG数据并以无线的方式将ECG数据传输至传感器50,用来与由系统参考电极158B探测的数据进行比较,以获得期望的P-波波形(如图16)。 This makes the second ground electrode are substantially equipotential, so that the wireless module 950 to use the wireless module ground electrode 952, and the ECG signal from the ECG sensor assembly of the stylet 130 (e.g., in one embodiment the core wire 138 (FIG. 12C -12E)), and to detect the ECG data wirelessly transmit the ECG data to the sensor 50, for comparison with the data from the detection system reference electrode 158B to obtain the desired P- waveform (FIG. 16). 在一个实施方案中,数据比较为在由探针130的ECG传感器组件、无线模块接地电极952与系统参考电极158B获得的ECG数据之间的差分比较。 In one embodiment, the comparison is a difference between the data comparison ECG data by the ECG sensor assembly of the probe 130, the wireless module ground electrode 952 and the system reference electrode 158B obtained. 在一个实施方案中,系统接地电极158A与无线模块接地电极952类似,可以为无源的并且不是电气驱动的。 In one embodiment, the system ground electrode 158A and the wireless module ground electrode 952 similar to, and may be passive and not electrically driven. 还要注意的是,在传输到传感器50或其他系统部件(例如控制台20)之前,模拟的ECG数据可以被数字化或者由无线模块950处理。 Also note that, prior to transmission to the sensor 50 or other system components (e.g., the console 20), the analog ECG data may be digitized or processed by the wireless module 950.

[0167] 图34根据一个实施方案将又另一无线结构描述为这样的装置,即用来在无菌区域和非无菌区域之间建立导电通路的装置。 [0167] FIG 34 describes the structure of still another radio according to an embodiment is a device that is used between the sterile and non-sterile fields to establish a conductive pathway. 如所示出的,在位置A的正电极954A和在位置B的负电极954B与传感器50 —起被包括,并且被安置在患者70的躯干上,而被标不在位置C的正无线模块电极956与无线节点950 —起被包括,正无线模块电极956被安置在患者邻近导管插入部位73上或邻近导管插入部位73中。 As shown, at position A the positive electrode 954A and 954B and the negative electrode 50 at the sensor location B - is included on, and positioned on the torso of patient 70, is not in the position labeled C of the positive electrode of the wireless module wireless node 956 and 950-- are included from, the positive electrode of the wireless module 956 is positioned proximate the catheter insertion site on the patient 73 or 73 adjacent the catheter insertion site. 探针130的ECG传感器组件,例如在一个实施方案中的芯线138,针对所描绘的结构的无线部分起到负电极(以其最终位置被标示于图34中的D处)的作用。 ECG sensor probe assembly 130, for example, in one embodiment the core wire 138, functions as a negative electrode (D is indicated at 34 in FIG its final position) of action for the radio section of the structure depicted. 注意的是,在一个实施方案中,电极954A和954B的位置A和B在患者身体上可以分别被改变,来为最佳的ECG信号接收协调系统10。 Note that, in one embodiment, the electrodes 954A and 954B, respectively, positions A and B may be changed in the body of the patient to the best of the ECG signal 10 received coordinate system.

[0168] 在本实施方案中,电极954A和954B为采样双极ECG信号起到第一独立源的作用。 [0168] In the present embodiment, the electrodes 954A and 954B function as a first independent source for sampling bipolar ECG signals. 来自这些电极的ECG数据被数字化,并且经由使传感器50和无菌区域外的控制台互相连接的线缆(路径I)被传送至控制台20或其他适合的系统部件。 The ECG data from these electrodes are digitized and transmitted to the system 20 or other suitable means console via a cable (route I) console outside the sterile field and the sensor 50 are connected to each other. 无线模块电极956和ECG传感器组件为采样双极ECG信号起到第二独立源的作用。 Wireless module electrode 956 and the ECG sensor assembly acts as a second independent source for sampling bipolar ECG signals. 来自这些电极的ECG数据被数字化,并且经由在无菌区域内的无线模块950 (路径2)被以无线的方式传送至控制台20。 The ECG data from these electrodes are digitized and transmitted wirelessly to the console 20 via the wireless module within the sterile field 950 (Path 2). 因此,在本实施方案中,无线模块950起到第一连通节点的作用,而控制台20的无线接收器起到第二连通节点的作用,用来在两个节点之间进行ECG信号的转换。 Accordingly, in the present embodiment, the wireless communication module 950 function as a first node, and a wireless receiver console 20 functions as a second communication node, for converting the ECG signal between two nodes . 注意的是,在其他实施方案中,前面提到的电极的极性可以是反过来的。 Note that, in other embodiments, the polarity of the electrodes mentioned above may be reversed.

[0169] 沿路径I和2 二者接收到的ECG信号由控制台20的适合的电路来进行基线矫正,以针对DC偏置和漂移进行调整。 [0169] received along both the path I and 2 ECG signals by a suitable baseline correction circuit of console 20, in order for the DC offset and drift adjusted. 在这样的矫正之后,可以生成未改变的参考或基线,例如在图35A中可见的来自路径I的P-波波形176A。 After such a correction, the reference may be generated or a unaltered baseline, for example visible in FIG. 35A from the path I P- waveform 176A. 类似地,从路径2中生成如在图35B中可见的P-波波形176B,这样的波形随着导管72中的探针130被朝向患者的心脏推进而改变。 Similarly, the path is generated from the 2 as seen in FIG. 35B 176B P- waveform, a waveform with a conduit 72 probe 130 is advancing toward the heart of the patient is changed. 在这样的推进期间,来自路径2的波形176B被从来自路径I的P-波波形176A中减去,例如利用数字差分放大器。 During such advance, the waveform 176B from the path 2 is subtracted from the waveform 176A from path P- I, for example by using a digital differential amplifier. 这种减去移除由信号中的每一个所表征的波形的所有共有分量,并且例如通过图35C中示出的波形176C可见的,使控制台20能够经由其显示器30来仅仅描绘这两个信号中的不同之处。 This is removed by subtracting, for example, shown by the waveform in FIG. 35C 176C can be seen from all the joint components each characterized by a waveform signal, so that the console 20 can both display 30 to depict only via its signal differences. 在导管推进期间,来自路径2的波形的P-波中的改变则可以被容易地观察到。 During the catheter is advanced, changing the P- wave from the waveform of the path 2 can be readily observed. 因此,本实施方案使得要被表征的ECG数据的数字显示是容易地可观察的,而防止用于这样的数据传输的无菌屏障(例如外科手术布单)的物理穿过。 Accordingly, the present embodiment to be characterized so that the digital display of ECG data is readily observable physical sterile barrier to prevent such data transfer (e.g., a surgical drape) therethrough.

[0170] 注意的是,在其他实施方案中,无线模块电极956可以包括其他结构,包括被嵌入到导引装置鞘中的导电元件,与患者的血流相接触,该导引装置鞘在导管放置期间通常被通过插入部位73来设置。 [0170] Note that, in other embodiments, the wireless electrode module 956 may include other structures, is embedded in the conductive element comprises a guide sheath, in contact with the bloodstream of the patient, the guide catheter sheath 73 during placement typically set by insertion site. 在一个实施方案中,导引装置可以在其近侧部分上包括连接器,来使其与无线节点950的接触得以进行。 In one embodiment, the guide means may include a connector on its proximal portion, so as to contact with the wireless node 950 is to be carried out.

[0171] 还要注意的是,根据本文所描述的实施方案,各种无线协议中的一个或更多个可以被用来传输无线信号,包括IEEE 802.11族的规范中的一个或更多个等等。 [0171] It is also noted that, according to embodiments described herein, various wireless protocols, one or more may be used to transmit a wireless signal, including IEEE 802.11 family of specifications of one or more other Wait. 还要注意的是,在一个实施方案中,无线模块可以与用于可操作地通过鞘连接无线模块电极的连接器一起被包括在如在前面的实施方案中所描述的无菌鞘中,以在无菌区域中拿起该模块,或者无线模块自身被包括在鞘中。 Also note that, in one embodiment, the wireless module may be operatively connected to wireless module connector for through the sheath and the electrode together is included in the sterile sheath as in the previous embodiments described in order to the pick module, or a wireless module in the sterile field is included in the sheath itself. 当然,还可以采用其他方法来将无线模块保持在无菌区域中。 Of course, other methods may also be used to maintain the wireless module in a sterile area. 在一个实施方案中,无线模块可以包括按钮,该按钮进一步从无菌区域内使能系统10的控制。 In one embodiment, the wireless module may include a button that the control system 10 to enable further from the sterile field.

[0172] 图36示出在一个实施方案中,传感器50可以被改进(retro-fitted)为具有无线模块960,以使由传感器接收到的信号能够被以无线的方式传输至控制台20或系统10的其他适合的部件。 [0172] FIG. 36 shows, in an embodiment, the sensor 50 can be improved (retro-fitted) with the wireless module 960, so that the signal received by the sensor 20 can be transmitted to the console system in a wireless manner or other suitable member 10. 例如,由接地和参考电极158A、158B(图34)接收到的ECG数据可以被传感器50接收,然后经由无线模块960以无线的方式被传输至系统控制台。 For example, by the ground and a reference electrode 158A, 158B (FIG. 34) receives the ECG data may be received sensor 50, and then transmitted via the wireless module 960 wirelessly to the system console. 无线模块960可以包括天线或其他传输部件并且可以可操作地经由传感器线缆962或其他适合的接口连接到传感器50ο注意的是,无线模块960可以与本文所描述的其他实施方案结合使用,包括例如图10和33中所描绘的实施方案。 Radio module 960 may include an antenna or other transmission component and may be operatively connected via the sensor cable 962 or other suitable interfaces to the sensor 50ο noted that the wireless module 960 can be combined with other embodiments described herein, include e.g. 10 and 33 as depicted embodiments.

[0173] 图37根据一个实施方案示出保持构件,用来防止鳍状连接器156从传感器连接器底部152或与鳍状连接器可操作地连接的其他插孔意外分离。 [0173] FIG. 37 shows a holding member according to one embodiment, the other jack to prevent accidental fin connector 156 from the sensor connector base 152 and the fin connector or operably linked to separate. 如所示出的,鳍状连接器156包括被柔韧地附接到鳍状连接器本体的保持臂970。 As shown, the fin connector 156 includes a flexible retaining arms attached to the fin connector body 970. 保持臂970包括舌(tab) 972,当鳍状连接器156被可滑动地接收在传感器凹槽152A中(图14A)时,舌972在与传感器50的连接器底部152—起被包括的边缘(Iip) 974之上滑动并与边缘974接合。 Retaining arm 970 comprises a tongue (tab) 972, when the fin connector 156 is slidably received in a recess in the sensor 152A (FIG. 14A), a tongue 972 at the bottom of the sensor 50 from the edge connector to be included 152- (Iip) above and 974 slidably engaged with the edge 974. 舌972与边缘974的接合防止鳍状连接器156在使用中的意外移除。 Engaging tongue 972 and the edge 974 of the fin connector 156 to prevent in use accidental removal. 当鳍状连接器156从传感器连接器底部152的移除是期望的时,保持臂970被抬起,以使舌972从边缘974脱离,此后鳍状连接器可以在不与传感器凹槽152A接合的情况下被滑动。 When the fin connector 156 is removed from the bottom of the sensor connector 152 is desired, the holding arm 970 is lifted, so that the tongue 972 is disengaged from the edge 974, after which the fin connector can not be engaged with the recess 152A in the sensor It is slid in a case. 这样的结构可以与其他保持构件(例如凹进168A(图13D)) —起使用或单独使用。 Such a structure can be kept with the other member (e.g. a recess 168A (FIG. 13D)) - used together or separately. 注意的是,在其他实施方案中,可以采用各种修饰和结构来帮助保持鳍状连接器和连接器之间的接合。 Note that, in other embodiments, various modifications and structures may be employed to help maintain engagement between the connector and the fin connector. 例如,在一个实施方案中,保持臂可以被可操作地附接到鳍状触头168 (图13D)中的一个或更多个,从而保持臂或其他适合的鳍状连接器部件的替换(例如横向地抬起移动、挤压等)使一个或更多个鳍状触头从底部触头(图15)脱离,从而减少由鳍状触头和底部触头的接合所提供的整体保持力。 For example, in one embodiment, the retaining arm may be operably attached to the fin contacts 168 (FIG. 13D) of one or more, thus replacing the retaining arm or other suitable fin connector member ( laterally lifting movement e.g., extrusion, etc.) that one or more fin contacts (FIG. 15) departing from the bottom of the contact, thus reducing the overall holding force by the engagement fin contacts and base contacts being provided . 进一步注意的是,这些原理可以被应用到除了在此所描述的鳍状连接器以外被公开或意图包括的其他连接器方案。 It is further noted that these principles can be applied in addition to the fin connector described herein are intended to be disclosed or other programs included in the connector.

[0174] 除了上面将各种连接方案描绘为这样的装置的实施方案以外,即用来在无菌区域和非无菌区域之间建立导电通路的装置,可以根据本领域技术人员的理解利用其他配置来实现相同的功能。 [0174] In addition to the above various embodiments depict a connection scheme other than the embodiment of such a device, i.e. means for establishing a conductive pathway between sterile and non-sterile areas used, may be utilized in accordance with other understood by those skilled in the art configured to achieve the same functionality. 这样的其他配置可以包括,例如ECG信号从探针到传感器或系统部件的无线传输、包括布单中的导电性螺接、包括无菌布单中的导电性窗口(例如,由导电性塑料或金属箔构成的)等等。 Such other configurations may include, for example, wireless transmission of ECG signals from the probe to the sensor or system components, including the drape of the conductive screwed, including a sterile drape in a conductive window (for example, conductive plastic or metal foil) and the like. 在又另一实施方案中,探针/导丝的近侧端自身可以被用来刺穿布单,以接收进入到传感器上的连接器中。 In yet another embodiment, the probe / guidewire proximal end itself may be used to pierce the drape, to receive into the connector on the sensor. 在这种情况下,没有绳缆被包括在探针的近侧端上,而探针自身起到导电通路的作用,用来将ECG信号从探针传感器组件传输到患者胸部上的传感器。 In this case, no tether is included in the proximal end of the probe, and the probe itself functions as a conductive path for the ECG signals transmitted from the sensor probe to the sensor assembly on the patient's chest. 这样的结构可以允许使用如在此所描述的探针/导丝来进行导管的丝上放置。 Such a structure may allow the use of such a probe / guidewire as described herein is placed on a wire to the catheter. 这样,上面的实施方案不应当以任何方式被理解为是对本发明的限制。 Thus, the above embodiments should not be construed as in any way limiting the present invention.

[0175] 图38示出导管982,作为可以与本文所公开的实施方案中描述的导管放置系统10一起被使用的导管的一个实施例。 [0175] FIG. 38 illustrates a catheter 982, catheter placement system as an embodiment of the catheter disclosed herein may be described in the 10 is used together with an embodiment. 导管982包括安置在邻近远侧端982B处(然而,沿所述导管的其他位置也是可能的)的导电环形带984,导电环形带984起到ECG传感器或电极的作用,用于在导管至少部分地被插入患者的脉管系统时检测从患者70的心脏结发出的ECG信号。 The catheter 982 includes a distal end disposed adjacent the at 982B (However, other locations along the catheter are also possible) with a conductive loop 984, conductive endless belt or the ECG sensor 984 functions as an electrode for at least a portion of the catheter It is detected ECG signals from the patient's heart when the junction 70 is inserted into the patient's vasculature. 导线986沿导管982的长度延伸并且在一个实施方案中被嵌入(例如通过共挤)导管壁,用于与患者外部的外部ECG信号接收部件的连接。 Wires 986 extend along the length of the catheter 982 and is fitted (e.g. by coextrusion) wall of the catheter, and outside of the patient for external ECG signal receiving component is connected in one embodiment. 要注意的是,除了上述的那些之外且本领域技术人员理解的,这只是导管和ECG传感器电极结构的一个示例性实施方案。 It is noted that, in addition to those mentioned above and appreciated by those skilled in the art, this is only an exemplary embodiment of a catheter sensor and the ECG electrode structure. 此外,其他可能的结构被公开于题目为“包括ECG传感器和磁性组件的导管组件(Catheter Assembly Including ECG Sensor and Magnetic Assemblies),,的美国公开号2010/0222664中,通过引用将其全部内容并入本申请。 In addition, other possible structure is disclosed in, entitled "ECG sensor assembly comprising a catheter and a magnetic assembly (Catheter Assembly Including ECG Sensor and Magnetic Assemblies) ,, U.S. Publication No. 2010/0222664 by reference in its entirety is incorporated The present application.

[0176] 图39根据一个实施方案示出用于与包括ECG传感器组件990的系统10 —起使用的导管982,其中所述导管包括多个ECG传感器或者电极994A、994B以及994C。 [0176] FIG. 39 illustrates a system including an ECG sensor assembly 10, 990 according to one embodiment - from the use of catheter 982, wherein said conduit comprises a plurality of ECG sensors or electrodes 994A, 994B and 994C. 电极994C被安置在邻近导管远侧端982B处,而剩下的电极994A和994B被安置在所述导管上邻近电极994C处。 Electrode 994C is disposed adjacent a distal end of the catheter 982B and the remaining electrodes 994A and 994B are disposed on the catheter adjacent the electrode at 994C. 每个电极可操作地连接到各自的导电通路,例如沿导管的长度从电极向近侧延伸的导线,从而使被检测的ECG信号能够被传送到外部TLS传感器50或者其他适合的系统部件。 Each electrode is operatively connected to a respective conductive path, for example, along the length of the catheter from the wire electrode extends proximally, such that the detected ECG signals can be transferred to the external TLS sensor 50 or other suitable system component. 电极994A-994C可以以适合作为传感器以检测患者心脏的ECG信号的多种结构中的一个或更多个来配置。 Electrodes 994A-994C may be a variety of configurations ECG signal detected in a patient's heart or be configured in a more suitable as sensors. 再者,尽管被示出为封口的,但在一个实施方案中导管982可以为开口的。 Further, although shown as a seal, in one embodiment, the conduit 982 may be opened.

[0177] 如在图40A-40C中所示,ECG传感器组件990可以被用来确定导管远侧端982B对SA结的邻近程度,其中在图示说明的实施方案中,导管982的传感器组件包括两个电极994A和994B。 [0177] As, the ECG sensor assembly shown in FIGS. 40A-40C 990 may be used to determine the proximity of the catheter distal end 982B of the SA node, which in the illustrated embodiment, the catheter 982 includes a sensor assembly two electrodes 994A and 994B. 在图40A中,当导管远侧端982B接近SA结时,分别由导管电极994A和994B检测的ECG波形的P-波996A和996B 二者示出P-波幅度上的增加。 In FIG 40A, when the distal end of the catheter close to the SA node 982B, respectively, illustrating the increase in wave amplitude P- P- wave by both the catheter electrodes 996A and 994A detects the ECG waveform 994B and 996B. 然而,因为其相对更加邻近SA结的位置,电极994B示出具有相对更大幅度的P-波。 However, because of its position relatively more proximate the SA node, the electrode 994B is shown having a relatively greater amplitude P- waves. 例如,如由系统10检测到的P-波996A和996B的叠加以998被示出。 For example, as detected by the system 10 P- waves 996A and 996B are shown superimposed to 998. 例如,在系统显示器上观察这种关系可以在导管的放置期间为临床医生给出所需的信息,从而帮助导管远侧端982B朝向SA结的推进。 For example, this relation was observed on the system display can give the required information to the clinician during the catheter placement to help advance the catheter distal end 982B toward the SA node.

[0178] 图40B示出当两个电极994A和994B相对于SA结等距时,P-波996A和996B的幅度是大致相等的,这个事实由P-波的叠加998来进一步示出。 [0178] FIG. 40B shows that when the two electrodes 994A and 994B with respect to the junction equidistant, P- wave amplitude of 996A and 996B are substantially equal SA, this fact is further illustrated by 998 P- wave superposition. 在图40C中,远侧电极994B比电极994A相对更远离SA结,并且这样其相应的P-波996B相对于P-波996A是较小的。 In FIG. 40C, the distal electrode 994B relatively farther away from the SA node electrode 994A, so that its respective P- and 996B with respect to the P- wave wave 996A is smaller. 要注意的是,电极的类型和数目可以不同于在此所示出的。 It is noted that the type and number of electrodes may be different from that shown herein.

[0179] 在另一实施方案中,滤波过程可以与在此描述的导管982的ECG电极994A、994B的使用结合进行,其中由电极检测的ECG波形的部分除了P-波部分都被除去,仅仅留下在这两个电极之间的被检测到的P-波中的不同来进行描绘。 [0179] In another embodiment, the filtering process may, 994B used in conjunction with ECG electrodes 994A of the catheter 982 described herein, which are removed from the portion of the ECG waveform detection electrode in addition to the P- wave portion only different leaving P- wave is detected between the two electrodes to perform drawing. 该过程类似于如上所述的结合图34-35C所进行的过程。 The process is similar to that described above in conjunction with FIGS. 34-35C.

[0180] 图41A-41C描绘针对ECG电极完整性指示器186的各种可能的状态,也被示出为图17中的系统显示器30的屏幕截图178上所显示的。 [0180] FIGS 41A-41C depict various possible states for the ECG electrode integrity indicator 186, as is also shown on the system display screen shot in FIG. 17 being displayed 17,830. 完整性指示器186是在系统显示器30上所显示的图标,并且是连接完整性部件的部分,以利用外部传感器50检验各种ECG信号路径的连接状态,即连接是否闭合并且是否准备好在导管放置过程中使用。 Integrity indicator 186 is an icon displayed on the system display 30, and the integrity of the connection member is partially, to test a variety of sensors 50 by the external ECG signal path connection state, i.e., whether the connection is closed and ready to catheter used during placement. 这样的引线检验是有益的,以避免如果在放置无菌布单且建立围绕患者的无菌区域之前各种ECG电极没有恰当地连接时,不得不移除无菌布单并重新开始放置过程。 Such a lead test is useful to avoid if placed in a sterile drape and establish various ECG electrodes are not properly connected prior to the sterile field around the patient, the sterile drapes have to remove and re-start the placement process.

[0181] 在图41A中,完整性指示器186示出当前到外部传感器50没有为闭合的连接。 [0181] In FIG. 41A, 186 integrity indicator 50 is not shown to be connected to external sensors currently closed. 相反,图41B示出传感器50和ECG电极158(图14B)之间的连接是闭合的,通过带阴影的连接符号1004来指示。 In contrast, FIG. 41B shows the connection between the sensor 50 and the ECG electrodes 158 (FIG. 14B) is closed, indicated by the shaded connection symbol 1004. 图41C示出除此之外,传感器50和探针130的ECG传感器之间的连接(例如图12C和12D中的芯线138经由绳缆134和绳缆连接器132)也是闭合的,如带阴影的连接符号1006所指示的。 FIG 41C shows the addition, the connection between the sensor 50 and the ECG sensor 130 of the probe (e.g. via the tether wire 138 132 and tether connector 134 of FIG. 12D and 12C) is closed, such as with shaded connection symbol 1006 indicated. 因此,图41A中的完整性指示器视图表征图14A中示出的连接状态,图41B中的指示器视图表征图14B中示出的连接状态,并且图41C中的指示器视图表征图14C中示出的连接状态。 Therefore, the connection state shown in FIG. 41A integrity indicator view in FIG. 14A characterization, the connection state shown in FIG 41B the indicator view in FIG. 14B characterization, and in view of the indicator of FIG. 41C to FIG. 14C Characterization It shows a connection state.

[0182]系统10可以使用连接完整性部件以各种方式中的一个或更多个确认上述连接的状态,所述连接完整性部件包括例如与传感器50和/或控制台20 —起被包括的电容或电感感测电路、基于阻抗的方法、时间或频率反射法技术等等。 [0182] The system 10 can use the state of the connection member to the integrity of one or more of various ways to confirm the connection of the connecting member comprises, for example, the integrity of the sensor 50 and / or console 20-- is included from capacitive or inductive sensing circuit, impedance-based method, the time frequency reflectometry technique or the like. 一种可能的基于电压平衡的连接完整性部件系统在图4ID中以1120示出。 One possible connection integrity based on the voltage balancing member system 1120 shown in FIG 4ID. 具体地,如图41D所示,系统1120的电路包括第一电阻对1120和可操作地经由通信线路1126连接的放大器1124(例如仪表放大器)作为本系统的另一部件。 Specifically, as shown in FIG. 41D, a circuit system 1120 includes a first resistor pair and the amplifier 1120 operably connected via a communication line 11261124 (e.g., an instrumentation amplifier) ​​as another component of the system. 第二电阻对1128、放大器1130和1132、模拟数字转换器(“ADC”) 1134以及处理器1136也被包括在所述系统中并且如图41D所示地相互连接。 A second pair of resistors 1128, 1130 and amplifier 1132, analog to digital converter ( "ADC") 1134 and a processor 1136 are also included in the system and connected to each other as shown in FIG. 41D. 在一个实施方案中,处理器1136被包括在外部TLS传感器50中,但是可以被并入其他系统处理器或被包括在其他部件中,例如一个实施方案中的控制台20中。 In one embodiment, the processor 1136 is included in the external TLS sensor 50, but other systems may be incorporated or included in a processor other components, such as a console 20 in the embodiment of the embodiment. 系统10的各种ECG电极被示出附接到患者70的身体,即诸如以图12A-12E中示出的结构的探针芯线138的内部ECG传感器(图41D中的El),以及图14A-14C中示出的外部参考外部ECG电极158 (E2)和第二外部电极(E3) 二者。 Various ECG electrodes of the system 10 is shown attached to the body of the patient 70, i.e., the core structure such as probe in FIG. 12A-12E shown internal ECG sensor 138 (El in FIG. 41D), and FIG. 14A-14C are shown with reference to both the outer external ECG electrodes 158 (E2) and a second outer electrode (E3).

[0183] 在针对使用系统10的准备中,完整性检查系统1120在一个实施方案中可以被用来确保外部ECG电极被恰当地连接到患者70的身体以及系统10的外部TLS传感器50 二者。 [0183] In preparation for use of the system 10, the integrity of the inspection system 1120 may in one embodiment be used to ensure that the external ECG electrodes are suitably connected to both the external TLS sensor 70 of the body of the patient 10 and the system 50. 以1140示出的参考电压Vref例如通过稳压器被驱动到预先确定的值,例如4伏特,而外部电极E3处的电压被保持在相对低的值,例如2伏特。 In 1140 the reference voltage Vref is shown, for example, driven by the regulator to a predetermined value, for example 4 volts, while the voltage at the external electrode E3 is maintained at a relatively low value, for example, 2 volts. 分别来自于图41D中的电极I和2的电压值Vl和V2被平均以生成以1142表示的共模电压Vcm。 FIG respectively from the I electrode 41D and voltage values ​​Vl and V2 2 are averaged to generate a common mode voltage of 1142 represented Vcm. 在一个实施方案中,当经由ADC 1134被采样时,处理器1136监控Vcm。 In one embodiment, when sampled via the ADC 1134, the processor 1136 to monitor Vcm. 当外部ECG电极E2和E3被恰当地连接到患者身体和TLS传感器50时,Vcm在数值上将被拉低,在一个实施方案中接近约2伏特,然而其他值也是可能的。 When the external ECG electrodes E2 and E3 are properly connected to the body when the patient and the TLS sensor 50, Vcm will be pulled low value, close to about 2 volts in one embodiment, although other values ​​are also possible. 然而,如果外部电极E2和E3中的一个或两个没有被恰当地连接,Vcm将被拉高至Vref的值,或者在本实施方案中为约4伏特。 However, if one or two external electrodes E2 and E3 are not properly connected, Vcm will be pulled up to the value Vref, or about 4 volts in the present embodiment. 这样,由处理器1136对Vcm的监控可以确定外部ECG电极的连通性。 Thus, it is possible to determine the connectivity of the external ECG electrodes by a processor of 1136 Vcm monitoring. 与外部ECG电极的连通性状态相关的这些数据可以通过处理器1136被传送到显示器30,用于通过图41A-41C中示出的显示器30上的指示器186进行描绘。 The data associated with the connectivity of the external ECG electrodes may be transferred to the processor 1136 via a display 30, depicted by a pointer 186 on the display 30 shown in FIG. 41A-41C.

[0184] 图42根据一个实施方案示出又另一可能的连接完整性部件结构,其中采用无源引线连续性检查系统,消除对从系统10的各种ECG电极延伸的引线注入电流的任何需要。 [0184] FIG. 42 shows yet another possible any desired injected from a variety of ECG lead electrodes 10 extending current system integrity member connecting structure in which a continuous passive lead inspection system, according to one embodiment to eliminate . 如所示的,辐射元件1010被包括在相对地靠近诸如在传感器50上的ECG电极引线处。 The radiating element 1010 is shown comprising in relatively close ECG electrode leads on the sensor, such as at 50. 辐射元件1010被配置来发射已知频率的信号。 Radiating element 1010 is configured to transmit the signal of known frequency. ECG引线(例如外部ECG电极158和绳缆134的线)作为天线无源地检测辐射元件1010辐射的信号。 ECG leads (e.g. external ECG electrodes 158 and tether line 134) as a passive antenna radiating element 1010 detects the signal radiation. 当ECG引线被恰当地附加到传感器50时,ECG引线的天线效应被最小化,以致出现在ECG引线上的辐射信号被抑制。 When 50 when the ECG leads are properly attached to the sensor, antenna effect ECG leads is minimized, so that the radiation signals appear on the ECG leads is suppressed. 传感器和/或控制台电路被这样配置以检测出现在ECG引线上的辐射信号并将其与阈值信号水平进行比较。 Sensors and / or the console circuitry is so configured to detect the presence of ECG leads on a radiation signal and compares it with a threshold signal level. 如果被检测的辐射信号在所述阈值之上,系统报告ECG引线没有被恰当地连接。 If the detected radiation signal above the threshold, the system reports ECG leads are not properly connected. 当被检测的信号低于所述阈值时,系统报告所述引线被恰当地连接。 When the detected signal is below the threshold value, the reporting system lead is properly connected. 本结构是无源的并且无需向ECG引线传输电流以检查针对连接路径检查的连接完整性。 This configuration is passive and does not need to transmit current ECG leads connect to check for integrity check of the connection path.

[0185] 在一个实施方案中,图42的连接检查示意图可以被配置,以致出现在引线上的不同等级的信号水平将指示在ECG电极上游的子连接是否闭合。 [0185] In one embodiment, the connection check schematic diagram 42 may be configured such that the signal appearing on lead levels will indicate different levels of connection is closed upstream of the sub ECG electrodes. 在另一实施方案中,自然地出现在引线上的自然频率60Hz、120Hz或180Hz中的自然信号线路噪声可以被用于检测,由此消除对辐射元件1010的需要。 In another embodiment, the leads occurs naturally in natural frequency of 60Hz, 120Hz, or 180Hz natural signal line noise may be used to detect, thus eliminating the need for the radiating element 1010.

[0186] 要理解的是,其他图标和设计可以被用来实现结合图41A-41C所描述的功能,并且该连接状态检查可以根据对导管放置系统所做的修改而改变。 [0186] is to be understood that other icons, designs may be used to implement the functions described in conjunction with FIG. 41A-41C, and the connection status check may vary according to the modification made to the catheter placement system. 当然,其他视觉或听觉指示可以被用来传达电极连接状态。 Of course, other visual or audible indication may be used to communicate electrically connected state.

[0187]图43A-43B描绘包括一模式的探针结构的细节,所述模式用于例如当导管72在被插入患者70之前被修剪(trim)时所述探针被不合期望地留在导管内腔中,检查此时探针130是否已经被不经意地切割(cut)。 [0187] FIGS. 43A-43B depict the details of a probe structure comprising a pattern, the pattern, for example, when the catheter 72 is inserted into the patient 70 prior to being trimmed (TRIM) the probe is undesirably left in the conduit lumen, the probe 130 is checked at this time has been inadvertently cut (cut). 如所示的,在一个实施方案中,探针130可以包括被管套(tubing sleeve) 1018覆盖的芯线1014和多个磁性元件1016,以及被包括在探针远侧端的导电性环氧树脂1020。 As shown, in one embodiment, the probe 130 may comprise a tubular sleeve (tubing sleeve) 1018 1014 covering the core wire and a plurality of magnetic elements 1016, and a probe comprising a conductive epoxy at a distal end 1020. 导线环1024被包括在探针中并且在探针130的远侧端130B形成回路,从而当与系统10适当地连接时形成电路。 Wire loop 1024 is included in the probe and the probe distal end 130 of the circuit 130B is formed, thereby forming the circuit when properly connected to the system 10. 由此,导线环1024限定检查探针远侧部分的连续性的连续电路。 Thus, a continuous wire loop continuity check circuit 1024 defining a distal portion of the probe. 如果探针已经被不经意地切割,例如通过如图43B中所示的不恰当的导管修剪,所述回路是开路的并且所述连续性检查失败,表示导管末端已经被损害。 If the probe has been inadvertently cut, such as by improper pruning catheter shown in FIG. 43B, the circuit is open and the continuity check fails, showing the catheter tip has been compromised. 连续性检查可以在导管72被插入到患者的脉管系统之前被执行,以防止在插入之后的导管引导问题。 Continuity check may be performed before the catheter is inserted into the patient's vasculature 72, to prevent problems after the guide catheter insertion. 在另一实施方案中,导线环1024可以被配置来被暴露于患者血液并且附加地起到ECG电极的作用。 In another embodiment, wire loop 1024 can be configured to be exposed to the blood of a patient ECG and additionally functions as an electrode.

[0188] 图44示出对先前实施方案的许多可能改变中的一个,其中导线环1024被实施为偏向于在最小厚度的平面内弯曲的平导线。 [0188] FIG. 44 illustrates one of many possible changes in the previous embodiment, wherein 1024 is implemented as a wire loop biased to bend in the plane of minimum thickness of the flat wire. 这样的平导线可以被用在诸如图44中所示的具有预先弯曲的结构的探针中。 Such flat wires may be used, such as shown in FIG. 44 having a pre-bent probe structure. 另外,在一个实施方案中,如果期望的话,这样的线使能探针弯向要被沿一个轴控制的方向。 Further, in one embodiment, if desired, such a bent line enable the probe to be controlled along one axis direction. 实际上,在一个实施方案中,张力可以被赋予所述平导线,以例如如图44中所示地导致探针130的远侧部分选择性地从笔直转向弯曲结构。 Indeed, in one embodiment, the tension may be imparted to the flat wire to cause the distal portion 130 of the selective probe shown in FIG. 44, for example, the steering is bent from a straight configuration. 应当要注意的是,刚刚描述的实施方案可以以这样的探针来实现,所述探针具有在结构、尺寸等方面的各种结构中的一个。 It is to be noted that the embodiment just described may be implemented in such a probe, the probe having a variety of structures in the structure, size, etc. of. 在其他实施方案中,要注意的是,在其他实施方案中,其他技术(例如包括使用时域或频域反射法的探针检查)可以被用来确保所述探针并未已经被切割或者被损害。 In other embodiments, it is noted that in other embodiments, other techniques (e.g., including the use of time domain or frequency domain reflectometry probe check) may be used to ensure that the probe has not been cut, or compromised.

[0189] 图45和46描绘用于防止探针130在导管72内的非预期的向近侧推进的机械方案。 [0189] Figures 45 and 46 depict a proximal for preventing unintended advancing probe 130 within the conduit 72 to a mechanical solution. 具体地,图45示出被包括在探针远侧端130B上的球状机械干涉构件1028,以阻碍探针缩入导管内腔。 In particular, FIG. 45 is shown on the probe comprising a distal end 130B of the spherical member 1028 mechanical interference, in order to hinder the probe is retracted into the catheter lumen. 图46示出另一实施例,其中所述探针远侧端130B包括被转向的延伸部分干涉构件1028。 FIG 46 shows another embodiment, wherein the probe comprises a distal end of the extension portion 130B of the steering interference member 1028. 当然,可以利用许多不同尺寸和形状的机械干涉构件,包括箭头形、球形等等。 Of course, many mechanical interference member may be utilized in different sizes and shapes, including arrow-shaped, spherical, and the like.

[0190] 图47A和47B描绘辅助防止导管72和探针130的远侧端未对齐的电气方案。 [0190] FIGS 47A and 47B depict the distal end of the auxiliary program to prevent electrical conduit 72 and probe 130 are not aligned. 如所示的,导电带1032被嵌入所述导管,以与探针130的两个导电部分1036电气连通,非导电探针部分1034被置于所述两个导电部分1036之间。 As shown, the conductive strip 1032 is embedded in said catheter to communicate with the two conductive probe portion 130 1036 electrically non-conductive probe portion 1034 is disposed between the two conductive portions 1036. 当探针远侧端130B被恰当地对齐导管72的远侧端72B时,更远侧的探针导电部分1036经由嵌入导管的导电带1032被导电地连接到更近侧的探针导电部分1036。 When the stylet distal end 130B are properly aligned distal end of catheter 72 72B, more distal portions of the conductive probe 1036 via conductive strip embedded in a more proximal catheter probe is conductively connected to the conductive portions 1036 1032 . 然而,如果探针和导管远侧端130B、72B没有对齐,则没有这样的导电路径被建立,并且这种路径的缺失可以通过系统10的传感器50、控制台20或者其他适合的部件来检测,以使能其修正。 However, if the probe and the catheter distal end 130B, 72B are not aligned, there is no such conductive path is established, and the absence of such a path may be 50, console 20, or other suitable components of system 10 by the sensor to detect, to enable its correction.

[0191] 图48描绘用于在导管放置过程中放置在患者70的皮肤上的双ECG电极组件1040的一个可能的实施方式。 Double ECG electrode assembly [0191] FIG. 48 depicts a catheter during placement is placed on the skin of the patient 70 in one possible embodiment 1040. 如所示的,组件1040包括双电极1042A、1042B、用于简化ECG引线放置的单个盘。 As shown, the assembly 1040 includes a two-electrode 1042A, 1042B, a simplified single disc ECG leads placed. 还包括相应的引线1044。 Further comprising a respective lead 1044. 在其他实施方案中,如果期望的话,ECG电极组件可以包括多于两个电极。 In other embodiments, if desired, the ECG electrode assembly may include more than two electrodes.

[0192] 图49示出用于放置在患者70的皮肤上的外部ECG外部电极组件的一个实施例,包括前述的鳍状连接器156和外部ECG电极158。 [0192] FIG. 49 shows an embodiment of an external ECG electrode assembly is placed on the exterior skin of the patient 70, including the fin connector 156 and the external ECG electrodes 158. 图形1048被安置在每个电极158的表面上,图形1048包括辅助临床医生将ECG电极放置在患者的身体上适合位置的图示。 Pattern 1048 is disposed on the surface of each electrode 158, an auxiliary pattern 1048 including the clinicians ECG electrodes placed on the patient's body for the illustrated position. 这辅助可能不熟悉在患者70的身体上用于电极的适合放置位置的临床医生。 This assistance may be unfamiliar to clinicians for the electrodes on the patient's body for placement of 70. 图示和具体的电极结构可以根据系统设计而改变。 Specific electrode structures shown and can vary depending on system design.

[0193] 图50-61描绘用于在导管放置系统的显示器(例如图10的系统10的显示器30)上显示ECG数据的各种可能的实施方式,用于辅助临床医生将导管放置到患者70的脉管系统中。 [0193] FIG. 50-61 depicts a catheter placement system in a display (e.g. display 30 of system 10 of FIG. 10) various possible embodiments of the ECG data on a display, for assisting the clinician placing the catheter into the patient 70 the vasculature. 在要遵循的许多实施方式中,呈现和显示ECG数据的标准方法被改进来帮助导管放置和末端定位的确认。 In many embodiments to follow, the standard method for presenting and displaying ECG data is improved to assist in placement of the catheter tip location and confirmation. 这样,如下的显示和计算方法对向临床医生呈现数据可以是有用的。 Thus, the display, and is calculated as follows for the presentation of data to the clinician may be useful.

[0194] 图50示出可闻(audible)或其他适合的反馈可以结合显示ECG迹线(例如在此示出的ECG迹线1050)被利用,所述反馈类似于在图17中的显示器屏幕截图178上所描绘的迹线历史窗口182。 [0194] FIG. 50 shows an audible (Audible), or other suitable feedback may be displayed in conjunction with ECG trace (e.g., shown here in the ECG trace 1050) is utilized, the feedback in Figure 17 is similar to the monitor screen Screenshot 178 depicted on the trace history window 182. 具体地,在一个实施方案中,声音或其他指示可以与ECG信号的ECG波形的一方面相关。 Specifically, in one embodiment, sound or other indication may be associated with an aspect of an ECG signal the ECG waveform. 在本实施方案中,可闻提示与ECG迹线1050中的每个波形176的P-波1052的幅度相关联。 In the present embodiment, the audible prompt ECG trace 1050 and each of the amplitude waveform 176 P- wave 1052 is associated. 随着P-波幅度如图50所示的变化,可闻提示可以相应地变化。 With the variation shown in FIG. 50 P- wave amplitude, audible prompt may vary accordingly. 可闻提示可以在频率、音量、连续性(例如单独点击相对连续音调)等方面被调制。 Audible prompt may be modulated in frequency, volume, continuity (e.g., a single click on a relatively continuous tone) and so on.

[0195] 图51示出描绘一方法的一个实施方案的流程图,所述方法用于就ECG波形176的一方面(例如P-波1052的幅度)进行相关且产生可闻或其他反馈。 [0195] FIG. 51 shows a flowchart depicting a method according to an embodiment of the method for correlating and generating audible or other feedback to an aspect of the ECG waveform 176 (e.g., amplitude P- wave 1052). 该方法在整体或部分上可以由系统10的适合部件(例如被包括在外部传感器50或控制台20中的电路),或者其他适合的导管或医疗设备放置系统来执行和/或控制。 The method in whole or in part may be made of suitable components of system 10 (e.g., included in the external sensor 20 or console circuitry 50) to perform, or other suitable catheter or medical device placement system and / or control. 在步骤1056中,在导管放置过程中,ECG信号数据以诸如在上面结合系统10的使用已经进行描述的方式被采样。 In step 1056, the catheter placement procedures, such as to the ECG signal data is sampled in the above manner in conjunction with the system 10 has been described. 在步骤1058中,ECG波形从被采样的ECG信号数据被识别。 In step 1058, the ECG waveform identification ECG signal data is sampled from. 在步骤1060中,ECG波形的P-波部分被识别。 In step 1060, P- wave portion of the ECG waveform is identified. 这可以通过诸如比较所述波形的部分与标准的预先加载的P-波模板以确定P-波1052的存在和位置来实现。 This may be by comparing the portions of the waveform, such as a standard preloaded P- wave template to determine the existence and location of the P- wave 1052 is achieved. 然后在步骤1062中确定P-波的幅度峰值。 Then P- wave amplitude peak is determined in step 1062. 在步骤1064中,P-波幅度峰值与相应的可闻或其他适合的反馈输出相关。 In step 1064, the peak correlation P- wave amplitude corresponding to output audible feedback or other suitable. 在一个实施方案中,该步骤可以通过系统10被预先确定并储存,或者可以动态地自动或通过使用者输入被控制。 In one embodiment, the step 10 may be determined in advance and stored by the system, or may be dynamically controlled by a user or automatically input. 然后在步骤1066中产生输出。 Then, in step 1066 generates an output. 要注意的是,在其他实施方案中,输出可以除了如已经被描述的可闻部分之外,包括例如可视、光/声结合、机械运动(振动)和/或其他感官提示,或者前述的组合。 It is noted that, in other embodiments, the output can be heard in addition to such portion has been described, including for example a visual, optical / acoustic coupling mechanical motion (vibration) and / or other sensory cues, or the aforementioned combination.

[0196] 图52-55使用图51所描绘的方法,给出可以与ECG信号数据的多个方面(例如每个被检测的ECG波形的P-波幅度)相关的可视输出的进一步的实施例。 The method depicted in [0196] FIG. 51 to FIG. 52-55, a further embodiment may be associated with a given plurality of aspects of ECG signal data (e.g. P- wave amplitude of each ECG waveform to be detected) of the visual output example. 例如,图52示出一个显示实施方式,其中每个ECG波形176的P-波1052被识别并利用颜色被突出显示以区分P-波与所述波形的其他部分。 For example, FIG. 52 shows a display embodiment in which each of the ECG waveform 176 of the P- wave 1052 is identified using a color and be highlighted to distinguish other P- wave portion of the waveform. 在一个实施方案中,所述颜色可以根据P-波幅度上的变化而变化。 In one embodiment, the color may change according to the P- wave amplitude.

[0197] 在图53中,每个波形176中的P-波1052的峰值幅度以作为时间函数的在ECG迹线1050上的带颜色或带阴影的阴影部分1070来追踪。 [0197] In FIG. 53, P- wave peak amplitude of each waveform 176 1052 to 1070 as a function of time hatched portion of colored or shaded in the ECG trace 1050 to track. 具体地,在导管插入期间,随着导管组件(例如导管和/或探针)的ECG传感器组件接近SA结或心脏的其他结,连续ECG波形176的P-波1052通常在幅度上变化。 In particular, during insertion of the catheter, with the catheter assembly (e.g., the catheter and / or probe) closer to the ECG sensor assembly of the SA node or other node of the heart, the continuous wave 176 of ECG waveforms P- 1052 typically vary in amplitude. 通常是有用的是,当这样的变化发生时,在系统显示器30上显示P-波1052的幅度。 It is often useful, when such changes, the display width of the P- wave 1052 on the system display 30. 可以使用线或带颜色的条(bar)来描绘出(trace out)过去峰值的幅度。 Or one may use a colored stripe (bar) to depict (trace out) past the peak amplitude. 以这种方式,当前和前一峰值幅度之间的比较可以以常规的方式进行。 In this manner, the comparison between the current and the previous peak amplitude can be carried out in a conventional manner. 无论迹线是否跨显示器移动,或者如果该迹线仍为静止且通过横扫(sweep across)所述显示器的移动条被刷新,都可以利用该显示模式。 Regardless of whether the trace moves across the display, or if the trace remains stationary and sweep through (sweep across) of the mobile display is refreshed strips, can use this display mode.

[0198] 图54示出一旦P-波1052落到先前的水平之下,如在图54的ECG迹线1050的最左侧部分中可见的,阴影部分1070的另一颜色或阴影可以被用来图示说明最近的峰值与先前峰值之间的不同。 [0198] FIG. 54 shows once P- wave 1052 falls below the previous level, as can be seen in the leftmost portion of FIG. 54 ECG traces 1050, the shadow of another color or shade 1070 may be used to illustrate the difference between the most recent peak and the previous peak. 可选地,水平线1074可以被用来描绘出如图55中的每个P波1052的峰值。 Alternatively, the horizontal line 1074 may be used to describe each of the P-wave peak 1052 in FIG. 55. 线1074可以在有阴影部分1070或没有阴影部分1070的情况下使用。 1074 can be used in line with a shaded or unshaded portion 1070 of the case 1070. 当然,许多其他这样的追踪实施方式和可视指示可以根据这些原理来设计。 Of course, many other such tracking and visual indication embodiments may be designed according to these principles.

[0199] 参照图56A-57B,描述例如当被显示在系统显示器30的迹线历史窗口182中时ECG迹线150的缩放控制的许多方面。 [0199] Referring to FIGS. 56A-57B, is described, for example, when displayed at the trace history window 30 of the display system 182 ECG trace many aspects zoom control 150. 在典型的ECG装置中,ECG波形显示的速率是恒定的。 In a typical ECG apparatus, the ECG waveform display rate is constant. 然而,人们的心跳速率不是恒定的,并且ECG波形形式和间隔因人而异。 However, it is not constant heart rate, ECG waveform and vary in form and spacing. 可能是有利的是,观察者能够改变波形的数目和/或波形被显示在系统显示器30或其他适合的装置上的时间量。 It may be advantageous that the observer can change the number and / or waveforms are displayed on the system display the amount of time or other suitable device 30. 这允许更多或更少的ECG波形被显示。 This allows more or fewer ECG waveform is displayed. 在一个实施方案中,临床医生可以调节显示设置以确定有多少ECG波形176被显示,或者所述波形要被显示多长时间。 In one embodiment, a clinician can adjust the display settings to determine how much of the ECG waveform 176 is displayed, the waveform to be displayed or how long. 在一个实施方案中,使用者可以从一系列预先限定的分立显示时间或波形选项中进行选择或者所述设置可以是使用者限定的。 In one embodiment, the user may from a series of predefined discrete time or waveform display option selection or the setting may be defined by the user. 在另一实施方案中,在ECG迹线1050的显示设置上的控件可以动态地或静态地被系统10自主地控制。 In another embodiment, the controls on the display settings of the ECG trace 1050 may be statically or dynamically by the control system 10 autonomously.

[0200] 作为上面ECG迹线时间窗口可变性的实施例,图56A示出作为迹线1050的一部分的以四波形的标准速率在所述窗口中被显示的ECG波形176,而图56B示出包括八个波形的增加的ECG迹线窗口。 [0200] As above ECG trace window time variability embodiment, FIG. 56A shows a portion of the ECG waveform trace 1050 at a rate of four standard waveform is displayed in the window 176, and FIG 56B shows increased eight waveforms including ECG trace window. 类似地,图57示出以五秒的标准迹线速率被显示的ECG波形数据,即每个波形176保持显示大约五秒;而图57B示出以相对更长的大约10秒的速率(即双倍标准迹线速率)被显示的ECG波形,以致峰值出现的相对更靠近在一起。 Similarly, FIG. 57 shows the ECG waveform data is displayed in standard trace rate of five seconds, i.e. each waveform display 176 maintained approximately five seconds; and Figure 57B illustrates a relatively longer rate of about 10 seconds (i.e. double standard trace rate) the ECG waveform is displayed, so that the peak is relatively closer together. 如图56A-57B所示,ECG迹线窗口的物理宽度保持一致,其中仅有被显示于此的波形的量被修改。 As shown in FIG. 56A-57B, the physical width of the ECG trace window consistent, in which only the display of the waveform is modified herein.

[0201] 图58示出描绘一方法的一个实施方案的流程图,所述方法用于以上面结合图56A-57B所描述的方式显示ECG信号数据。 [0201] FIG. 58 shows a flowchart depicting a method according to an embodiment, the method is used in the manner described above in connection with FIGS. 56A-57B show the ECG signal data. 要注意的是,该方法在整体或部分上可以由系统10的适合的部件(例如被包括在外部传感器50或控制台20中的电路)或者其他适合的导管或医疗设备放置系统来执行。 It is noted that this method in whole or in part may be made of suitable components of system 10 (e.g., included in the external sensor 20 or console circuitry 50) to perform, or other suitable catheter or medical device placement system. 在步骤1080中,在导管放置过程中,ECG信号数据以诸如上面已经结合系统10的使用所描述的方式被采样。 In step 1080, during catheter placement, the ECG signal data such as described above have been combined to use system 10 is sampled as described. 在步骤1082中,ECG波形(例如图56A-57B中的波形176)从被采样的ECG信号数据被识别。 In step 1082, ECG waveform (such as waveform 176 in FIG. 56A-57B) is identified ECG signal data is sampled from. 在步骤1084中,显示窗口(例如用于显示图56A-57B的ECG迹线1050的图17中所示的迹线历史窗口182)的参数被限定。 In step 1084, the display (trace history window 182 as shown, for example, for displaying the ECG FIGS 56A-57B trace 1050 in FIG. 17) is defined in the parameter window. 这些参数可以为,例如要被包括在所述窗口中的ECG波形的数目,或每个波形保持在屏幕上的时间量。 These parameters may be, for example, the amount of time to be held on the screen includes a number of ECG waveforms in the window of the or each waveform. 如步骤1088所示,所述参数可以为使用者限定或自主限定并且以静态(例如在工厂预先设置)或动态(例如通过所述系统根据反馈自主调节)方式被控制。 As shown in step 1088, the user may define the parameters defined and static or autonomously (e.g., factory preset) or dynamic (e.g., self-regulation by the system according to the feedback) controlled manner. 要理解的是,所述参数可以关于ECG迹线或波形的其他显示方面,包括例如波形高度、线宽度等。 Is to be understood that the parameters may be displayed with respect to other aspects of the ECG trace or waveform, for example, comprise a wave height, line width. 另夕卜,所述参数可以被限定,以致例如在被刷新之前,零、一、二或者更多个ECG波形被显示在所述迹线窗口中。 Another Bu Xi, the parameters may be defined, so for example, before being refreshed, zero, one, two or more ECG waveforms are displayed in the trace window.

[0202] 在步骤1085中,ECG波形根据所限定的显示窗口参数被显示。 [0202] In step 1085, ECG waveform is displayed based on the display window defined by the parameters. 如所示,在一个实施方案中,步骤1085可以包括步骤1086和1090。 As shown, in one embodiment, step 1085 may comprise steps 1086 and 1090. 在步骤1086中,如果被步骤1084中限定的参数允许,ECG波形与先前的波形组合。 In step 1086, if the parameters defined in step 1084 allows, the ECG waveform in combination with the previous waveform. 在步骤1090中,当被步骤1084中限定的参数允许时,ECG波形与任何先前的波形一起被显示。 In step 1090, when the parameter defined in step 1084 allows, the ECG waveform is displayed together with any previous waveform.

[0203] 图59示出个别的迹线窗口,如已经被描述的,其中在导管放置过程中,单个ECG波形176被显示并且当新的波形被系统10识别到时被周期性地刷新。 Individual trace window [0203] FIG. 59 shows, as has been described, wherein the catheter placement procedure, a single ECG waveform 176 is displayed and when a new waveform is periodically refreshed to the identification system 10. 例如,如图17示出的显示器屏幕截图178所反映的这样的迹线窗口被用于系统显示器30的当前ECG波形窗口180和窗P 184A、184B和184C。 For example, FIG. 17 shows a screenshot of a display of the current ECG waveform window such trace window 178 is used to reflect the display system 180 and the window 30 P 184A, 184B, and 184C. 如已经被描述的,ECG波形176包括P-波1052和QRS波群1096。 As has been described, ECG waveform 176 includes P- wave 1052 and 1096 QRS complex. P-波1052的峰值大小和QRS波群1096大小之间的比率可以以数值(如图59所示)或其他适合的形式被显示在迹线窗口中,以在导管72被推进通过患者70的脉管系统时辅助临床医生确定ECG波形的变化。 The ratio between the peak magnitude of the QRS complex 1052 and 1096 may be sized P- waves or other suitable form is displayed in a numerical value (FIG. 59) of the trace window to be advanced through the catheter 72 to the patient 70 assist the clinician to determine changes in the ECG waveform when the vasculature. 在每个新的ECG波形被描绘在个别迹线窗口中时,比率被更新。 Each new waveform is depicted an ECG trace window in the individual, the ratio is updated.

[0204] 图60示出描绘一方法的一个实施方案的流程图,所述方法用于以上面结合图59所描述的方式显示ECG波形。 [0204] FIG. 60 shows a flowchart depicting one embodiment of a method, the method is used in the above described in conjunction with FIG. 59 displays the ECG waveform. 要注意的是,该方法在整体或部分上可以由系统10的适合的部件(例如被包括在外部传感器50或控制台20中的电路)或者其他适合的导管或医疗设备放置系统来执行和/或控制。 It is noted that this method in whole or in part may be made of suitable components of system 10 (e.g., included in the external sensor 20 or console 50 circuitry) and to perform, or other suitable catheter or medical device placement system / or control. 在步骤1100中,在导管放置过程中,ECG信号数据以上面已经结合系统10的使用所描述的方式被采样。 In step 1100, during catheter placement, the ECG signal data to above has been used in conjunction with the system 10 of the embodiment described is sampled. 在步骤1102中,ECG波形(例如图59中的波形176)从被采样的ECG信号数据被识别。 In step 1102, ECG waveform (such as waveform 176 in FIG. 59) is identified ECG signal data is sampled from. 在步骤1104中,ECG波形176的P-波部分被识另O。 In step 1104, ECG waveform P- wave portion 176 is the other identification O. 这可以例如通过比较波形的部分与标准的预先加载的P-波模板以确定P-波1052的存在和位置来实现。 This may be, for example, by comparing portions of the waveform with a standard preloaded P- wave template to determine the existence and location of the P- wave 1052 is achieved.

[0205] 在步骤1106中,P-波幅度的大小和QRS波群幅度1096的大小之间的比率被确定。 [0205] In step 1106, the ratio between the magnitude of the amplitude of the QRS complex and the amplitude of the P- wave 1096 are determined. 在一个实施方案中,该步骤可以包括确定P-波的幅度峰值,从ECG波形176识别QRS波群1096以及确定QRS波群大小的大小。 In one embodiment, the determining step may include P- wave amplitude peak, the ECG waveform QRS complex 176 identifying and determining the size of the 1096 size QRS complex. 在步骤1108中,ECG波形176被显示在诸如系统显示器30(图17)的当前ECG波形窗口180中或窗口184A、184B和184C中的一个中。 In step 1108, ECG waveform 176 is displayed on a display such as the system 30 (FIG. 17) of the current ECG waveform window 180 or window 184A, 184B and 184C in one. 如果期望的话,波形176可以利用通过步骤1106所获取的P-波/QRS波群比率数据来显示。 If desired, the waveform 176 may be utilized P- wave acquired by the step 1106 / QRS wave group ratio data is displayed. 如图60所示,工序流程可以被重复,以当新的ECG波形被产生并检测时,获取和显示所述新的ECG波形。 As shown in 60, as shown in process step may be repeated in order when a new ECG waveform is generated and detected, new acquisition and display of the ECG waveform.

[0206] 步骤1110包括定格图像输出选项,其中使用者可以选择所显示的ECG波形176并将其定格在显示器中,由此中断工序流程的重复,或者可选地防止新获取的波形被显示。 [0206] Step 1110 includes freeze image output options, wherein the user can select the displayed ECG waveform 176 and fixed in the display, thereby interrupting the repeated process flow, or alternatively to prevent the newly acquired waveform is displayed. 再者,在所述工序流程期间可以执行步骤1112,其中与所识别的ECG波形相关的数据被发送到储存位置或装置。 Further, during the process step of step 1112 may be performed, wherein the data associated with the identified ECG waveform is sent to a storage location or device. 如果期望的话,所储存的图像然后可以被显示在诸如系统显示器30 (图17)的窗口184A、184B和184C中的一个中。 If desired, the stored images can then be displayed on a display such as system 30 (FIG. 17) of the windows 184A, 184B and 184C in the.

[0207] 图61示出出于记录保存/文档的目的可以被打印并使用以检验导管72在患者70的脉管系统内的恰当放置的导管放置记录1114的一个实施例。 [0207] FIG. 61 shows for the purpose of record keeping / documentation can be printed and used to verify proper placement of catheter 72 within the patient's vasculature 70 of a catheter placement record 1114 of the embodiment. 在一个实施方案中,记录1114可以包括开始ECG波形176A和最终ECG波形176B,开始ECG波形176A表征在导管72被首次引入患者的脉管系统时的ECG波形,最终ECG波形176B表征在所述导管的远侧端被安置在其邻近患者的心脏的期望位置或其他适合的位置时的ECG波形。 In one embodiment, the recording start 1114 may include an ECG waveform 176A and 176B final ECG waveform, ECG waveform 176A begins characterized in ECG waveform when the catheter is first introduced into the patient's vasculature 72, characterized in the final ECG waveform 176B of the catheter the distal end is disposed adjacent to the heart at a desired location of the patient or other suitable location ECG waveform. 传感器50的图像表征120可以与被描绘在传感器图像上的探针远侧端图标114 一起被包括,以表征所述探针的最终放置位置,并且由此也表征导管的最终放置位置。 Characterization of the image sensor 50 may be included with 120 depicted on the image sensor of the stylet distal end icon 114, to characterize the final placement of the probe, and thus also of the final placement of the catheter characterized. 日期、时间、患者ID等也可以被包括在记录1114中。 Date, time, patient ID may also be included in the record 1114. 在一个实施方案中,用于临床医生或责任方签字的地方也可以被包括。 In one embodiment, a clinician or signature of the responsible party places may also be included. 在一个实施方案中,记录1114可以为经由系统10是使用者可修改的,从而允许针对各种医院和诊所手术和需求的定制。 In one embodiment, the recording system 10 via 1114 may be user modifiable, allowing customization for various hospitals and clinics surgery and needs. 记录1114的打印输出可以经由被包括在US探测器40、系统控制台20等上的适当的按钮来执行。 Printout via the record 1114 may include performing at 40, the appropriate button on the system console 20, etc. US probe. 在另一实施方案中,如果期望的话,图27所示的脚踏开关1116或其他适合的界面可以被用于捕捉和打印记录1114。 In another embodiment, if desired, foot switch 1116 shown in FIG. 27, or other suitable interface may be used to capture and print the record 1114.

[0208] 图62示出出于记录保存/文档的目的可以被打印并使用以检验导管72的恰当放置的导管放置记录1114的又另一实施例。 [0208] FIG. 62 shows for the purpose of record keeping / documentation can be printed and used in the proper placement of the catheter 72 catheter placement test recording and 1114 according to another embodiment. 在一个实施方案中,记录1114可以包括三个窗口,其中每个窗口描绘传感器图像120和选定的末端位置以及ECG波形数据。 In one embodiment, the record 1114 may include three windows, and wherein the selected end position 120 and the ECG waveform data of each sensor image drawing window. 例如,图62中的记录1114示出左侧窗口、中间窗口以及右侧窗口,所述左侧窗口包括在导管72被首次引入脉管系统时的开始ECG波形176A和相应的ECG迹线1050,所述中间窗口包括修正的ECG迹线1050和在所述导管如探针远侧端图标114所示的被安置时表征ECG波形的中间ECG波形176C,所述右侧窗口包括更新的ECG迹线1050和在所述导管如探针远侧端图标114所示的最终被安置时表征所述ECG波形的最终位置ECG波形176B。 For example, record 1114 in FIG. 62 is shown in the left window, and right window middle of the window, the window on the left comprises a conduit beginning ECG waveform 176A is at first introduced into the vasculature 72 and corresponding ECG trace 1050, the window comprises an intermediate correction waveform ECG trace 1050 and 176C in the distal end of the catheter probe characterized ECG waveform when the icon is positioned intermediate ECG 114 shown in the right window of the ECG trace including the updated 1050 and characterizing the ECG waveform when the catheter is positioned as shown in the final end of the probe distal end position icon 114 ECG waveform 176B. 当然,其他配置/信息可以被包括在所述记录中。 Of course, other configuration / information may be included in the record.

[0209] 如本文所述的,通过使用系统10所获取的各种数据可以被储存和/或评估,用于当前或稍后使用。 [0209] As described herein, the various data 10 by using the acquired system may be stored and / or evaluated, for current or later use. 具体地,在一个实施方案中,通过使用系统10所获取的TLS磁性元件追踪数据和ECG信号检测数据二者可以被储存以如本领域技术人员所知晓地使用。 Specifically, in one embodiment, the TLS magnetic element 10 by using the acquired system to track both the data and the ECG signal detection data may be stored as in the present art known to the art used. 在一个实施方案中,针对导管72的TLS磁性元件追踪数据和ECG信号检测数据可以与脉管系统内的导管位置相关联,作为时间的函数,以致导管放置的记录可以实时地被构建或者通过数据的储存被稍后进行。 In one embodiment, the TLS magnetic element tracking data for catheter 72 and ECG signal data may be detected with a catheter within the vasculature associated with the position, so that the catheter placement record can be constructed by the data in real time or as a function of time the store is later. 这样的数据在导管放置过程中可以实时地被储存,以在放置期间如果所述系统临时或非预期地关闭时以自动防故障装置模式进行操作。 Such data may be stored in real time during catheter placement, to operate in a fail-safe mode when the system is expected to be temporary or closed during placement. 此外,数据在以下方面可以是有用的,即通过计算当前探针远侧末端位置和P-波幅度被最大化的位置之间的距离,相对于ECG信号的峰值P-波幅度正确定位探针位置。 Further, the data may be useful in the following ways, i.e. by calculating the distance between the current position of the probe distal tip P- wave amplitude is maximized and a position, with respect to the P- wave amplitude peak of the ECG signal correctly positioning probe position. 数据还可以被用来提供关于这样的路径的三维信息,沿所述路径所述导管在患者脉管系统中被推进。 Data may also be used to provide three-dimensional information on such a path, along the path of the catheter is advanced in the patient vasculature.

[0210] 导管或医疗设备的多个方面的图标表征 [0210] Characterization of icons or more aspects of the medical device conduits

[0211] 现在参考图63和64,其描绘根据一个实施方案配置的放置系统(“系统”)10的各种部件。 [0211] Referring now to FIGS. 63 and 64, depicting the various components 10 in accordance with one embodiment of the placement system ( "system") of the program configuration. 如所示的,所述系统10—般地包括控制台20、显示器30、探测器40以及传感器50,其中每一个在下面被进一步详细描述。 As shown, the system includes a camel 10- console 20, display 30, probe 40 and sensor 50, each of which is described in further detail below. 由于所述系统10与上面已经描述的系统在许多方面类似,因此下面仅讨论所选择的特征。 Since the system 10 is similar to the system already described above in many respects, and therefore only the features discussed below selected.

[0212] 图64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。 [0212] FIG. 64 shows the 70, 73 in the course of the catheter 72 into the vasculature of a patient through the skin insertion site, the general relationship of these components relative to the patient. 图64示出导管72 —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。 FIG 64 shows the catheter 72-- camel comprising a proximal portion remaining outside of the patient 74 and distal left in the patient vasculature after placement portion 76 is completed. 在本实施方案中,系统10被用来将导管72的远侧末端76A最终安置在患者脉管系统中的期望位置。 In the present embodiment, the system 10 is used to the distal tip 76A of the catheter 72 is disposed within the patient vasculature final desired position. 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。 In one embodiment, the distal tip of the catheter 76A, the desired location is adjacent to the patient's heart, for example, in the superior vena cava ( "SVC") under the third (1/3) the inner portion. 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。 Of course, the system 10 may be used to place the catheter distal tip in another position. 导管近侧部分74还包括毂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。 Catheter proximal portion 74 further includes a hub 74A, a hub 74A provides a conduit 72 or more lumens extending between the legs 74B fluid communication to one or more proximally extending from the hub.

[0213] 控制台20的示例性实施方式被示于上面图SC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。 [0213] exemplary embodiment of console 20 is shown in FIG above the SC, however, it is appreciated that the console in a variety of forms may be employed. 包括非易失性存储器(例如EEPR0M)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。 Includes a nonvolatile memory (e.g. EEPR0M) is included in the processor 22 in console 20, for the role of function of the system during operation of system 10 is controlled, so that the control functions of the processor. 与控制台20 —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。 And console 20-- onwards, further comprising a digital controller / analog interface 24 and the digital controller / analog interface 24 while the processor 22 and other components of the communication system, to control the detector 40, sensors 50 and other system components connection interface between.

[0214] 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、键盘等待。 [0214] The system 10 further includes a sensor 50 and a port 52 connected to optional member 54, including a printer, storage media, the keyboard waits. 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。 In one embodiment the port is a USB port, although other types of ports or port type combinations may be used to connect the ports and other interfaces described herein. 与控制台20—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。 From console 20, including power connection means 56, 58 to enable connection of the external power supply device is operable. 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。 Using the internal battery 60 may be used with an external power supply or internal battery 60 alone. 与所述控制台20的数字控制器/模拟界面24 —起,包括有电源管理电路59,以调节电源的使用及分配。 The console controller 20 and the digital / analog interface 24-- from, including a power management circuit 59, and used to regulate power allocation.

[0215] 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。 [0215] In the present embodiment, the display 30 is integrated into the console 20, and is used in catheter placement procedures to display information to the clinician. 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。 In another embodiment, the display may be separate from the console. 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。 As will be appreciated, the contents of the display 30 according to the described mode the catheter placement system (US, TLS, or ECG to confirm the end of the other embodiments) is changed. 在一个实施方案中,控制台按钮界面32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。 In one embodiment, the console button interface 32 and the buttons included on the probe 40 may be used to invoke a desired pattern directly to the clinician in order to play a supporting role to the display 30 during placement . 在一个实施方案中,来自多种模式(例如TLS和ECG)的信息可以被同时显示。 In one embodiment, information from multiple modes (e.g. TLS and ECG) may be displayed simultaneously. 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。 Accordingly, a single system console 30 of the display 20 may be used for ultrasound guidance performed at the time into the patient's vasculature, the TLS guide catheter through the vasculature in the propulsion process, and (as described later in ECG-based acknowledgment scheme) catheter distal tip relative to the patient's heart knot placement. 在一个实施方案中,所述显示器30为一IXD设备。 In one embodiment, the display device 30 is a IXD.

[0216] 探测器40被用来与上面提到的所述第一方式一起使用,S卩,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。 [0216] probe 40 is to be used with the first embodiment mentioned above, S Jie, vessel (e.g., vein) based on ultrasound ( "US") visualization of the catheter 72 is inserted into the vasculature prepare for. 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。 Such visualized as the catheter into the patient's vasculature to provide real-time ultrasound guidance, and help reduce complications typically associated with such introduction, including accidental arterial perforation, hematoma, pneumothorax and the like.

[0217] 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。 [0217] Thus, in one embodiment, a clinician using the first (US) to determine the appropriate manner and form a vascular access insertion site, for example, by a needle or introducer device, and then using a catheter. 然后,所述临床医生可以经由推按探测器按钮控制板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。 Then, the clinician can seamlessly switch via a push button control panel detector to the second button (TLS) mode, without having to go outside the sterile field. 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。 Then, the TLS mode may be used to help the catheter 72 through the vasculature advance toward the intended destination.

[0218] 图63示出探测器40还包括按钮和存储控制器42,用来控制按钮和探针的操作。 [0218] FIG. 63 shows the probe 40 further includes a button 42 and a memory controller for controlling the operation buttons and the probe. 在一个实施方案中,按钮和存储控制器42可以包括非易失性存储器,例如EEPR0M。 In one embodiment, buttons 42 and a memory controller may include a nonvolatile memory, e.g. EEPR0M. 按钮和存储控制器42与控制台20的探测器接口44是可操作地通信的,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控制器42接口连接的按钮和存储器输入/输出部件44B。 Button 42 and a memory controller interfaces with the detector 44 of the console 20 is in operable communication, a piezoelectric detector includes an input interface 44 connected to the piezoelectric detector array interface / output section 44A, and with and with the button in the memory input / output unit connected to the interface 42 and a memory controller button 44B.

[0219] 注意的是,在所述US方式的系统10的使用期间,尽管静脉被典型地描绘在显示器上,在其他实施方案中其他身体内腔或部分可以被成像。 [0219] Note that, during use of the system 10 of the embodiment of the US, although the veins are typically depicted on a display, lumen or other body part can be imaged in other embodiments. 注意到的是,如果期望的话,所述US模式可以同时与其他模式(例如,所述TLS模式或ESG模式)一起被描绘在显不器30上。 It is noted that, if desired, the US mode may be depicted simultaneously with other patterns (e.g., the mode or ESG mode TLS) on the display unit 30 is not. 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。 During catheter placement, in addition to visual display 30, the system 10 may also be employed aural information (e.g., beeps, tones, etc.) to assist the clinician. 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。 Further, the detector 40 includes a push button and the console button interface 32 may be configured in various ways, including in addition to a slide switch used, for example a button, a switch, or a touch-sensing electronic board or the like the user input control means. 附加地,在系统10的使用期间,US、TLS以及ECG的活动可以同时发生或单独发生。 Additionally, during use of the system 10, US, TLS and ECG events may occur simultaneously or separately.

[0220] 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。 [0220] As just described, handheld ultrasound probe 40 is used as part of an integrated catheter placement system 10, to enable the outer periphery of the patient's vasculature US visualization, the catheter is percutaneously introduced into the preparation. 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。 However, in the present exemplary embodiment, as described below, when the guide catheter in the vasculature towards its desired destination proceeds, the probe is also used to control the system 10 TLS or second functional mode. 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。 Moreover, since the probe 40 is used in the sterile field of the patient, this feature enables complete control of the functions of the TLS from the sterile area. 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。 Thus, the detector 40 is a dual-purpose equipment, from the sterile field for convenient US and TLS control functions of the system 10. 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。 In one embodiment, as will be further described below, the probe can also be used to control associated with the ECG or catheter placement system some or all functions of the third embodiment 10.

[0221] 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。 [0221] The catheter placement system 10 further includes the second embodiment mentioned above, i.e., based on the catheter tip location system TLS or the magnetically. 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”)或其他适合的导管或医疗设备。 During the initial advancement into and through the patient's vasculature 70, the TLS enables the clinician to quickly locate and confirm the position of the catheter 72 and / or orientation of the catheter 72, for example, the outer peripheral venipuncture central venous catheters ( "PICC"), a central venous catheter ( "CVC"), or other suitable catheter or medical device. 具体地,所述TLS方式检测由装配有磁性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。 Specifically, the TLS mode is detected by the probe tip location equipped with a magnetic excitation of the magnetic element, in one embodiment, the probe tip location is preloaded into the lumen defined by a longitudinal manner in the conduit 72 so that the clinician to determine the general location and orientation of the catheter tip within the patient's body. 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。 In one embodiment, one can use the following U.S. patents or more of the teachings of the magnetic assembly track: 5, 775,332; 5,879,297; 6,129,668; 6,216 , 028 and 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。 Entirety herein by reference in the aforementioned U.S. patents are incorporated herein. 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。 The TLS also shows the catheter tip direction pointed to further aid in accurate placement of the catheter. 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。 The TLS further assist the clinician in determining the misalignment occurring when the catheter tip is, for example, the terminal has deviated from the desired path into the vein of another case when the vein.

[0222] 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。 [0222] As mentioned, the TLS using a probe to the distal end of the catheter 72 can be tracked in its passage through the vasculature to promote the process. 在一个实施方案中,所述探针包括近侧端和远侧端,其中在所述近侧端包括有手柄,以及从所述手柄向远侧延伸的芯线。 In one embodiment, the probe includes a proximal end and a distal end, wherein the proximal end comprises a handle, and a core wire extending distally from the handle. 磁组件被设置在所述芯线远侧。 Magnet assembly is disposed distally of the core wire. 所述磁组件包括一个或更多个邻近探针远侧端被彼此相邻设置且由管封装的磁性元件。 Said magnet assembly comprises one or more proximate the stylet distal end is disposed adjacent to each other by a magnetic element and the tube package. 在本实施方案中,包括有多个磁性元件,每一个元件包括与其他磁性元件以端对端的方式堆叠的固体圆柱状铁磁体。 In the present embodiment, comprises a plurality of magnetic elements, each element comprising a magnetic element with other stacked end to end of the solid cylindrical ferromagnetic. 粘合剂末端可以在磁性元件远侧塞堵管的所述远侧末端。 Adhesive ends may plug plugging the distal tip of the magnetic element distally.

[0223] 请注意的是,在其他实施方案中,所述磁性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。 [0223] Note that in other embodiments, the magnetic elements in not only shape, the design in terms of composition, number, size, magnetic type, and position in the distal segment of the probe you can also vary. 例如,在一个实施方案中,所述多个铁磁性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。 For example, in one embodiment, the plurality of ferromagnetic elements is replaced by an electromagnetic assembly, for example, a magnetic field generating electromagnetic coil is detected by the sensor. 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(Medical Instrument Locat1n Means) ” 的美国专利N0.5,099,845 中得到,本文通过引用将其全部内容并入本申请。 In another embodiment of this embodiment of the available components may U.S. Patent N0.5,099,845 "medical device positioning means (Medical Instrument Locat1n Means)" is obtained from the subject, herein by reference in its entirety is incorporated herein . 此外,包括可以与所述TSL方式一起使用的磁性元件的探针的其他实施例可以在题目为“探针仪器及制造方法(Stylet Apparatuses and Methods ofManufacture) ”的美国公开号2007/0049846中得到,本文通过引用将其全部内容并入本申请。 Further, a probe comprising a magnetic element that can be used with another embodiment of the TSL embodiments may entitled "apparatus and method for manufacturing a probe (Stylet Apparatuses and Methods ofManufacture)" U.S. Publication No. 2007/0049846 resulting in herein by reference in its entirety is incorporated herein. 因此,本发明的实施方案意图包括这些和其他变体。 Thus, embodiments of the present invention is intended to include these and other variations. 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。 It should here be understood that as used herein "probe" may be configured to include a removable manner to facilitate placement of the distal end of the catheter placed in the lumen of the catheter in a patient in any of a variety of devices in vasculature position desired. 在一个实施方案中,所述探针包括导丝。 In one embodiment, the probe comprises a guidewire.

[0224] 图64示出探针130的设置情况,探针130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。 [0224] FIG. 64 shows a case where the probe 130 is provided, the probe 130 is substantially in the lumen of the catheter 72, the proximal portion such that the probe 100 extends proximally from the catheter lumen, through a hub 74A and 74B extending through the selected extension legs. 这样设置在所述导管内腔中,在本实施方案中的探针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所进行的相对应的探测指示所述导管远侧端的位置。 Thus the catheter lumen disposed at the distal end of the catheter with the distal end 100B of the probe 100 of the present embodiment is substantially co-terminal 76A such that the distal end of the probe TLS corresponding to the detection performed by indicating the location of the catheter distal end. 在其他实施方案中,探针的远侧端与导管或医疗设备之间的其他关系是可能的。 In other embodiments, other relationships between the distal end of the probe to the catheter or medical device is possible.

[0225] 在TLS操作期间,系统10采用TLS传感器50以检测由探针100的磁性元件106产生的磁场。 [0225] TLS during operation, the system 10 uses the TLS sensor 50 to detect the magnetic field generated by the magnetic element 100 in the probe 106. 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。 As shown in FIG. 2, during catheter insertion, the TLS sensor 50 is placed in the patient's chest. 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),以使能如上面所描述的被设置在导管72中的探针磁性元件的磁场,来使其在导管通行经过患者脉管系统期间被检测到。 The TlS sensor 50 placed in the patient's chest predetermined position (e.g., by using a flag outside of the body), so that the magnetic field probe element can be provided as the catheter 72 as described above, so as to pass in the conduit during the patient's vasculature through it is detected. 再者,因为探针磁组件的磁性元件与导管72的远侧端76A(图64)是共端头的,由TLS传感器50所进行的所述磁性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。 Further, because the magnetic element and the distal end of a catheter probe 76A of the magnet assembly 72 (FIG. 64) is co-terminal, to provide the clinician about the magnetic field detected by the magnetic element sensor 50 of the TLS said distal end of the catheter during its passage position and orientation information.

[0226] 更具体地,如图63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。 [0226] More specifically, as shown in Figure 63, the TLS sensor 50 is connected to the system console 20 via a port 10, 52 or more operable. 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。 Please note that may be used without limitation other TLS connection scheme between the sensor and the system console. 正如所描述的,磁性元件被用在探针100中以使导管远侧端76A(图64)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。 , The magnetic element as described is used in a probe 100 to the distal end 76A of the catheter (FIG. 64) is placed in a position opposing the TLS sensor 50 of the patient's chest to be observable. 在TLS模式期间,由TLS传感器50所进行的探针磁性元件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。 During the TLS mode, the probe detecting the magnetic element sensor 50 of the TLS 106 to be graphically displayed on the display 30 of console 20. 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。 In this manner, the catheter is placed substantially the clinician to determine the position of the catheter distal end relative to the TLS sensor 50 76A in a patient vasculature, and detect when catheter malposition (e.g., the catheter along an undesired vein, performed promotion) is when occurred.

[0227] 如上面讨论的,在本实施方案中系统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。 [0227] As discussed above, in the present embodiment, the system 10 includes additional features, the catheter distal tip 76A opposing the sinoatrial ( "SA"), or other patient cardiac electrical pulses 70 emitted determining proximity of the junction It can be confirmed, thereby providing an enhanced ability to accurately place the catheter distal tip in a desired position adjacent the junction. 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。 Further, we referred to herein as "ECG" or "ECG-based tip confirmation", the third embodiment of the system 10 to enable the detection of ECG signals from the SA node, to the catheter distal tip in the vasculature system of the patient in a desired location described below. 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,但是可以被一同使用或单独使用来帮助放置导管。 Note that the US, TLS and ECG modalities are seamlessly combined in the present system 10, but may be used together or separately to help position the catheter. 在一个实施方案中,要理解的是如本文所描述的ECG方式可以被包括在独立系统中而不包括US和TLS方式。 In one embodiment, the ECG is to be understood that the embodiment as described herein may be included in a stand-alone system does not include the US and TLS mode. 因此,本文描述的实施方案所处的环境被理解为仅仅是示例性的环境而不能被认为是对本公开的限制。 Thus, the environment in which embodiments described herein are to be construed as merely illustrative of the environment can not be considered as limiting the present disclosure.

[0228] 如讨论的,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。 [0228] As discussed, to a catheter probe 130 is removably set in advance catheter 73 through the insertion portion 70 is inserted into the patient 72 in the lumen. 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传感部件(即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,用于探测由所述SA结产生的ECG信号。 Probe 130, in addition to including a magnet assembly based on the TLS mode magnetically outside, near its distal end including a sensing member (i.e., an ECG sensor assembly), and includes co-terminus with the distal end of the catheter tip portion, for detecting ECG signals produced by the SA node. 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。 Probe 130 including 134, tether 134 is operably connected to the TLS sensor 50 extending from the proximal end of the tether. 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。 As will be further described in detail, as part of the validation process of the ECG signal identification method based on the end position of the catheter tip, the probe 134 allows the tether to be included in a distal portion of the probe 130 the ECG sensor assembly on the detected ECG signal 50 is transmitted to the TLS sensor. 在本实施方案中,参考和接地ECG电极附接到患者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。 In the present embodiment, the reference and ground ECG electrode is attached to the body of the patient 70 and is operably attached to the TLS sensor 50 to enable the system to filter out the high irrespective of the electrical activity of the SA node of the heart level of electrical activity, thus enabling the ECG-based tip confirmation functionality. 接收自被放置在患者皮肤上的ECG电极的参考信号和接地信号,与由所述探针ECG传感器组件探测的所述ECG信号一起被安置在患者胸部的TLS传感器50 (图10)或系统10的其他指定的部件接收。 Received from the patient's skin is placed on the ECG electrode signals and ground reference signals, and the ECG signal from the ECG sensor assembly of the probe detected with the patient's chest is arranged in the TLS sensor 50 (FIG. 10) or the system 10 the other designated receiving member. 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上产生一个或更多个心电图波形或迹线。 As will be described, TLS sensor 50 and / or the console processor 22 may process the ECG signal data to generate one or more electrocardiogram waveforms on the display 30 or traces. 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。 50 in a case where the processing of the ECG signal data TLS sensor, wherein the processor is included in the function intended to achieve. 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。 If the console 20 processes the ECG signal data, the processor 22, a controller 24 or other processor may be applied in the console to process the data.

[0229] 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。 [0229] Accordingly, as it is advanced through the patient's vasculature, as described above, the probe 130 is fitted with a catheter 72 can be disposed in advance on the patient's chest TLS sensor 50 (FIG. 10) under . 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。 This makes the TLS sensor 50 can detect the position of the probe 130 of the magnetic assembly, said magnetic assembly distal tip 130 of the positioning of the catheter probe within the patient's vasculature 76A is substantially co-terminal of. 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。 During ECG mode, the probe is detected by the magnetic assembly of the TLS sensor 50 is depicted on the display 30. 在ECG模式期间,显示器30还可以描绘由探针130的所述ECG传感器组件(本文也称作ECG传感器部件)所检测到的患者心脏电活动的结果所产生的ECG心电图迹线。 During ECG mode, the monitor 30 may also depict the results of ECG patient cardiac electrical activity by the probe of the ECG sensor assembly 130 (also referred to herein means ECG sensor) detected by the ECG traces generated. 更具体地,包括P-波迹线的所述SA结的所述ECG电活动由所述探针的所述ECG传感器组件检测,并且被传送至TLS传感器50和控制台20。 More specifically, the P- wave traces including the SA node of the ECG electrical activity detected by the ECG sensor assembly of the probe, and the TLS sensor 50 and transmitted to console 20. 然后,所述ECG电活动被处理以在显示器30上进行描述。 Then, the ECG electrical activity to be processed on the display 30 will be described. 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。 Subsequently, a clinician placing the catheter can observe the ECG data to determine the optimal placement of the distal tip 76A of the catheter 72, for example proximate the SA node in one embodiment. 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63))。 In one embodiment, console 20 comprising the probe receives and the signal detected by ECG sensor assembly of the necessary electronic components (e.g., processor 22 (FIG. 63)). 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。 In another embodiment, TLS sensor 50 may include the necessary electronics process the ECG signal.

[0230] 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。 [0230] As already discussed, during placement of the catheter, the display 30 is used to display information to the clinician. 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。 30 according to the content of the display mode (US, TLS, or ECG) of the catheter placement system is changed. 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。 Now clinician may call any one of three modes to the display 30, and in some cases, information from multiple modes (e.g. TLS and ECG) may be displayed simultaneously. 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。 In one embodiment, and as before, where the mode of the system may include a control by the control buttons on the handheld detector 40, thereby eliminating the clinician to the sterile field (e.g., the touch control button interface 32 of the station 20) to change the mode need. 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。 Accordingly, in the present embodiment, the detector 40 is also used to control some or all ECG-related functionality of the system 10. 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。 Note that the button interface or other input structures 32 may also be used to control system functions. 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。 Similarly, during catheter placement, in addition to the use of visual display 30, the system may also be employed aural information (e.g., beeps, tones, etc.) to assist the clinician.

[0231] 鉴于上面与图63和64有关的讨论,图65_75描绘关于系统和方法的各种细节,在用于在患者的身体内放置导管的过程中,所述系统和方法用于描绘与导管(或其他留置医疗设备)的远侧部分有关的多维位置和定向信息。 [0231] In view of the above in connection with FIGS. 63 and 64 related discussion, FIG 65_75 depict various details regarding systems and methods, the procedure for placing a catheter within a patient's body, the system and method for depicting the catheter (or other indwelling medical devices) multi-dimensional position and orientation information regarding the distal portion. 在一个实施方案中,如上面描述的,所述多维位置和定向信息用被描绘在系统10的显示器30上的图标来体现,所述系统10被配置用于在患者的脉管系统中准确地放置所述导管。 In one embodiment, as described above, the multi-dimensional position and orientation information with the icon is depicted on the display 30 to reflect the system 10, the system 10 is configured in a patient's vasculature accurately placing the catheter. 在一个实施方案中,系统10采用末端定位/导引系统(“TLS”模式),所述末端定位/导引系统采用在导管末端通过弯曲的脉管系统路径的推进过程中对所述导管末端的基于磁方式的追踪,以在这样的推进过程中探测并便利对任何末端错位的纠正。 In one embodiment, system 10 employs tip location / guide system ( "TLS" mode), the terminal positioning / guidance system employing the catheter tip at the end of the catheter is advanced through tortuous vasculature process paths based magnetic tracking mode to detect and facilitate in advancing this process for any tip malposition correct. 另外,在一个实施方案中系统10包括用于改善导管放置的准确性的其他形式,所述形式包括用于将导管导入患者的脉管系统的超声辅助引导(“US模式”),以及基于ECG信号的导管末端引导(“ECG模式”),所述基于ECG信号的导管末端引导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。 Further, in one embodiment, the system 10 includes other forms for improving catheter placement accuracy of forms including, for introducing the catheter into the patient's vasculature auxiliary guide ultrasound ( "US mode"), and based on the ECG the guide catheter tip ( "ECG mode") signal, the guide can guide the catheter tip to a desired position with respect to the generation of cardiac junction of a patient ECG signal the ECG signal-based catheter tip. 本文也将这样的基于ECG的安置辅助称为“末端确认”。 Such paper also ECG-based assist placement referred to as "tip confirmation." 如本领域技术人员所理解的,在系统显示器30上的图标的描绘可以与系统10所执行的TLS模式、ECG模式或其他适合的模式结合出现。 As those skilled in the art will appreciate, the icon depicted on the display system 30 may be performed with the TLS mode system 10, ECG pattern or other suitable pattern binding occurs.

[0232] 如上面以及结合已经讨论的实施方案所描述的,图标114被系统10描绘在显示器30上来传达与被设置在导管72中的探针130的远侧部分的检测有关的信息。 [0232] The above embodiments have been discussed in conjunction with, and as described, the icon 114 is depicted system 10 detects information about a distal portion of the probe 130 up to communicate with the display 30 is disposed in the conduit 72. 下面将要讨论的图标可以被使用在结合系统10已经讨论的实施方案中。 Icon will be discussed in the embodiments may be used in conjunction with system 10 already discussed.

[0233] 根据一个实施方案,如已经描述的,图标114可以视觉地指示关于探针远侧端的位置、定向以及其他方面的各种信息片段,以及由此指示导管本身的远侧端。 [0233] According to one embodiment, as already described, the icon 114 may visually indicate the location of the distal end of the probe, orientation and other aspects of the various pieces, and thereby indicating a distal end of the catheter itself. 图65示出图标114在描绘以TLS和/或ECG模式由系统10检测的探针远侧端的位置和定向信息两者方面的各种实施例。 65 shows a drawing in the icon 114 to TLS and / or ECG implemented by various modes of both the position of the distal end of the probe 10 and detection system according to aspects of orientation information. 特别地,在图65中的图标114的各种视图包括定向指示器1502以及位置和深度指示器1504两者,所述定向指示器1502描绘探针130的远侧部分的定向(图63、64),所述位置和深度指示器1504描绘指示探针远侧端的位置和深度。 In particular, various view icon 114 in FIG. 65, the orientation indicator comprises both the position and depth indicator 1502 and 1504, the orientation of the orientation indicator 1502 is depicted in a distal portion of the probe 130 (FIGS. 63, 64 ), the position and the drawing position and depth indicator 1504 indicating the depth of the distal end of the probe.

[0234] 更详细地并且如提及的,图标114的定向指示器1502在显示器30上描绘探针的定向或“偏航(yaw) ”,即传感器50 (图63、64)所检测的探针末端指向的方向。 [0234] In more detail, and as mentioned, the orientation indicator 114 depicts an icon 1502 or the orientation of the probe "yaw (Yaw)" on the display 30, i.e. a sensor 50 (FIG. 63) detected Probe the needle tip pointing direction. 在本实施方案中,如示出的,定向指示器1502被实施为细长的杆1512。 In the present embodiment, as shown, the orientation indicator 1502 is implemented as an elongated rod 1512. 在系统操作期间,在显示器30上所描绘的杆1512的定向表征邻近探针的远侧端的探针的部分,从而指示探针远侧端已经推进的方向。 During system operation, on the display 30 in the orientation depicted in the rod 1512 of the characterizing portion of the probe adjacent the distal end of the probe, indicating the direction of the probe distal end has been advanced. 随着探针在脉管系统中移动,图标114及其杆1512相应地在显示器30上移动。 As the probe is moved in the vasculature, the icon bar 1512 and 114 correspondingly move on the display 30.

[0235] 图标114的位置和深度指示器1504表示传感器50 (图64)所检测的探针远侧末端的二维位置(即,如在图64中示出的在xyz坐标轴的xy平面上的末端位置)以及探针末端在患者内的深度两者。 [0235] icon 114 location and depth indicator 1504 indicates the two-dimensional position of the probe distal tip of the sensor 50 (FIG. 64) are detected (i.e., on as shown in FIG. 64 in the xy plane of the xyz coordinate axes end position) and the depth of both the probe tip within a patient. 在本实施方案中,如示出的,所述位置和深度指示器1504被实施为同心圆阵列(“圆阵列”)1514。 In the present embodiment, as shown, the location and depth indicator 1504 is implemented as an array of concentric circles ( "circular array") 1514.

[0236] 圆阵列1514的中心指示探针远侧末端在患者身体内且相对于传感器50的χ-y位置,而圆阵列的相对尺寸指示探针远侧末端的深度。 Center [0236] circular array 1514 in the distal tip of the probe is indicative of the patient's body with respect to χ-y position sensor 50, and the relative size of the circle indicates the depth of the array of the distal tip of the probe. 例如,在图65中的最左边的图标114包括在其圆阵列1514中所包括的相对多的同心圆,指示探针远侧末端相对地邻近传感器50,或者在患者身体内处于相对浅的深度,其相当于沿图64中的xyz坐标轴的垂直或z轴的一位置。 For example, the leftmost icon 114 in FIG. 65 comprises a plurality of opposing concentric circular array in which 1514 included, indicating the probe distal tip 50 relative to the sensor adjacent to, or at a relatively shallow depth in the body of the patient , a vertical or z-axis position of the xyz coordinate axes which corresponds to 64 in FIG.

[0237] 与此相反,最右边的图标114在其圆阵列1514中包括相对少的同心圆,指示探针远侧末端相对地远离传感器50,或者在患者身体内处于相对较深的深度。 [0237] In contrast to this, the rightmost icon 114 includes a relatively small concentric circle in its array 1514, indicating the probe distal tip 50 is relatively far from the sensor, or at a relatively deep depth in the body of the patient. 因此,图标114的杆1512和圆阵列1514在显示器30上的形态(appearance)能够向系统10的使用者指示探针远侧末端的四维空间状态:其xyz轴位置和深度三维定位,以及其偏航定向(即,第四维)。 Thus, an array of circular rods 1512 and 1514 form icon 114 on the display 30 (Appearance) capable of indicating the state of the four-dimensional space to the distal tip of the probe 10 of the user of the system: its location and depth of an xyz three-dimensional positioning, as well as partial Hang orientation (ie, the fourth dimension). 这样的图标描绘向放置导管的临床医生提供有用的且可容易识别的信息,其中上面描述的图标114所提供的深度指示可以被用来确定何时所述导管在脉管系统内位置异常。 Such icons depicting the clinician placing the catheter to provide useful and easily identifiable information, wherein the depth indicator 114 is provided as described above may be used to determine when the position of the catheter within the vasculature abnormal. 当然,如将要看到的,其他医疗设备可以类似地被追踪,其他用于定向和位置/深度指示器的形状和结构可以被使用,并且除了定向、位置以及深度以外的探针末端方面可以被描绘。 Of course, as will be seen, other medical devices may similarly be tracked, other shapes and configurations for the orientation and position / depth indicator may be used, in addition to the probe and the tip is oriented aspects, the position and the depth may be drawing.

[0238] 图70描绘根据本实施方案的图标114及其相应的定向指示杆1512和位置/深度指示圆阵列1514,连同系统传感器50(图64)所检测的在患者身体内的相应的探针远侧末端深度的实施例。 [0238] FIG. 70 depicts 1514, the corresponding probe in the body of the patient / depth indicator system in conjunction with a circular array sensor 50 (FIG. 64) detected by the icon 114 of the embodiment and corresponding program indicating the orientation and position of the bar 1512 Example embodiments distal tip depth. 当然,这仅仅是图标尺寸-深度对应的一个实施例;其他情况也是可能的。 Of course, this is merely an icon size - a depth corresponding to the embodiment; other conditions are also possible. 另外,在其他实施方案中,本文示出的图标特征可以被采用来表征所检测的探针末端或其他适合的留置医疗设备的其他方面。 Further, in other embodiments, features illustrated herein, the icon may be employed other suitable probe tip or other indwelling medical apparatus characterized detected.

[0239]图66示出根据一个实施方案的方法1530,其中系统10或其他适合的设备可以检测、计算和描绘图标114。 [0239] FIG. 66 illustrates a method according to one embodiment 1530, wherein the system 10 or other suitable device may detect, calculate, and icon 114 is depicted. 在步骤1532中,多个强度测量值从被包括在传感器50中的各种传感器部件从其以TLS模式(图64)对探针的磁性组件的检测取得。 In step 1532, a plurality of intensity measurements therefrom in TLS mode (FIG. 64) to obtain a probe for detecting a magnetic component from various sensor component is included in the sensor 50. 这些测量值被使用在步骤1534中,以计算探针远侧末端的位置和定向数据。 These measured values ​​are used in step 1534 to calculate the distal tip of the probe position and orientation data. 特别地,在步骤1536和1538中,探针远侧末端的X和I位置被计算,随后在步骤1540被描绘在系统10的显示器30上。 In particular, in 1536 and 1538, X I and probe distal tip position is calculated, then on the display 30 is depicted in system 10 in step 1540. 如提及的,在图65中示出的实施方案中,探针远侧末端的xy位置被显示为图标114的圆阵列1514的中心。 As mentioned, in the embodiment shown in FIG. 65, the XY position of the probe distal tip icon 114 is displayed at the center of the circular array 1514.

[0240] 类似地,在步骤1542中,探针远侧末端的z位置被计算,随后在步骤1544中被描绘在显示器30上。 [0240] Similarly, in step 1542, z position of the distal tip of the probe is calculated, then at step 1544 is drawn on the display 30. 如提及的,在图65中示出的实施方案中,探针远侧末端的z位置被显示为图标114的圆阵列1514,其中相对较大的阵列尺寸指示在患者身体内较浅的探针远侧末端z位置。 As mentioned, in the embodiment shown in FIG. 65, z is the position of the distal tip of the probe is displayed as a circle icon array 114 of 1514, which indicates a relatively large size of the array in the patient's body shallower Probe needle distal tip location z.

[0241] 在步骤1546中,探针远侧末端的定向被计算,随后在步骤1548被描绘在显示器30上。 [0241] is calculated, the orientation of the distal tip of the probe in step 1546, then delineated on the display 30 in step 1548. 如提及的,在图65中示出的实施方案中,所述探针的远侧部分的定向被显示为杆1512,其中所述杆的纵向延伸指示这样的方向,探针远侧末端在患者身体内刚刚已经从该方向行进。 As mentioned, in the embodiment shown in FIG. 65, the orientation of the distal portion of the probe 1512 is shown as a rod, wherein said longitudinally extending lever indicating such a direction, the probe distal tip just has traveled from the direction of the patient's body. 在一个实施方案中,除了在此讨论的步骤以外的或者代替在此讨论的步骤的步骤也可以被包括在方法1530中。 In one embodiment, the step of, in addition to the steps discussed herein or instead of steps discussed herein may also be included in the process 1530. 注意的是,在一个实施方案中,步骤1536、1538、1542和1546的计算可以通过系统控制台20 (图63)的处理器22或者通过其他适合的系统部件执行。 Note that, in one embodiment, calculation step 20 may 1536,1538,1542 and 1546 (FIG. 63) performed by processor 22 or other suitable system component via the system console.

[0242] 图67A-67F描绘用于图标114在描绘与探针远侧端的三维位置和定向(即第四维)有关的四维信息方面的其他可能的结构的实施例。 [0242] FIGS. 67A-67F depict a three-dimensional position and orientation of an icon 114 is depicted with the distal end of the probe (i.e., the fourth dimension) related to other possible embodiments of a four-dimensional structure of the information areas. 图67A示出如结合图65讨论的包括杆1512和同心圆阵列1514的图标114。 67A illustrates as discussed in conjunction with FIG. 65 includes a rod 1512 and a concentric circular array of icons 1,141,514. 在图67B中,图标114包括作为定向指示器的杆1512以及被实施为同心圆阵列的位置和深度指示器。 In FIG 67B, the icon 114 includes a directional indicator lever 1512, and is implemented as a concentric circle array position and depth indicator. 特别地,所述圆阵列可以包括实线(solid)环1514A和弱化(faded)环1514B两者。 In particular, the array may comprise a round solid line (Solid) rings 1514A and weakening (Faded) both ring 1514B. 随着探针远侧深度增加,弱化环1514B的数量增加,取代原来存在的实线环1514A。 With increasing depth probe distal weakened to increase the number of rings 1514B, substituted cycloalkyl originally present in the solid line 1514A.

[0243] 在图67C中,图标114包括杆1512和固定尺寸的同心圆阵列1510A,所述杆1512起到定向指示器的作用,所述同心圆阵列1510A起到示出xy探针远侧末端位置的末端图标1510的作用。 [0243] In FIG 67C, the icons 114 comprising an array of concentric circular bars 1512 and 1510A fixed size, play the role of the orientation indicator 1512 of the lever, the concentric circular array 1510A functions as shown the distal tip of the probe xy end position of the icon of the 1510 action. 邻近所述末端图标1510包括条形图1514B。 Adjacent the tip 1510 includes a bar graph icon 1514B. 当探针远侧末端被安置相对传感器50浅深度时,条形图1514B的相对较多的条(用黑白方案、彩色等)被实心填充或者以其他方式改变,反之亦然。 When the probe distal tip 50 is positioned relatively shallow depth sensor 1514B is relatively large bar bar (black and white embodiment, color, etc.) is solid filled or otherwise altered, and vice versa. 在图67D中示出的实施方案包括垂直标尺1564而不是条形图,和沿所述垂直标尺滑动来指示探针远侧末端深度的箭头1566,其中随着末端深度增加所述箭头在垂直标尺上下滑。 In the embodiment in FIG. 67D illustrated embodiment includes a vertical scale rather than 1564 bar, and sliding along the vertical scale to indicate the depth of the probe distal tip of the arrow 1566, which increases with the depth end of the vertical ruler arrow on the decline.

[0244] 在图67E中,图标114包括指示探针远侧末端定向的杆1512以及指示χ-y末端位置的固定的末端图标1510。 [0244] In FIG 67E, an icon indicating a probe comprising a distal tip 114 of rod 1512 directed χ-y indicating the end position of the fixed end 1510 icon. 此外,杆1512的长度根据末端深度而变化,其中相对较短的杆长度指示较深的末端深度。 Further, the length of the rod end 1512 varies depending on the depth, wherein a relatively short length of the bar indicating the end of a deep depth. 在图67F中,杆1512包括多个杆段1574,所述杆段1574根据探针远侧末端深度而在数量上变化,其中相对较少数量的可见的杆段指示较深的末端深度。 In FIG. 67F, the shaft 1512 comprises a plurality of rod segments 1574, 1574 and vary in number according to the depth of the probe distal tip section of the rod, wherein the relatively small number of visible rod end segment indication deeper depth. 注意的是,本文描述的各种图标元件可以被使用来指示探针远侧末端、导管或其他医疗设备的其他方面。 Note that the various icon elements described herein may be used to indicate other aspects of the probe distal tip, a catheter or other medical device. 例如,在图67C的图标114中被用来指示探针末端深度的条形图1554可以被使用在其他实施方案中,来指示关于探针远侧末端的位置、定向等的(由系统10所确定的)置信度水平。 For example, the icon 114 in FIG. 67C is used to indicate the depth of the probe tip 1554 bar may be used in other embodiments, to indicate the location of the distal tip of the probe, orientations, etc. (by the system 10 determined) confidence level. 同样地,在图67F的图标114中被用来指示探针末端深度的杆段1574可以被使用在其他实施方案中,来指示由所述系统确定的探针远侧末端的置信度水平。 Similarly, the icon 114 in FIG. 67F is used to indicate the depth of the probe tip rod segment 1574 may be used in other embodiments, to indicate the confidence level of the distal tip of the probe is determined by the system. 因此,这些和其他变体被意图用于图标114的各种元件和指示器。 Thus, these and other variations are intended for the various elements and indicator icons 114.

[0245] 图68A-69分别描绘用于图标114在描绘与以下内容有关的四维和五维信息方面的其他可能的配置的实施例:探针远侧末端的三维位置;其定向(即第四维);俯仰,或者在从图64中示出的xyz坐标轴的视角的z方向上探针远侧部分的偏差角,也被称为探针信息的第五维,并且指示探针远侧端正在接近或远离传感器50(图64)时所处的角度;以及置信度水平,即由系统10所确定的探针位置的正确性的置信度水平,本文也被称为探针信息的第六维。 [0245] FIGS. 68A-69 depict embodiments may be used in other embodiments of the icons 114 arranged in the four-and five-dimensional drawing information related to the following: three-dimensional position of the distal tip of the probe; its orientation (i.e., the fourth dimension); pitch, or angle deviation of the distal portion of the probe in the z direction from the perspective shown in FIG. 64 xyz coordinate axes, also referred to as probe information to the fifth dimension, and indicating the probe distal which the correct angle when approaching or away from the sensor 50 (FIG. 64); and a confidence level, i.e., the confidence level of accuracy of the determined position of the probe system 10, herein also referred to as probe information six-dimensional.

[0246] 例如,在图68A和68B中,图标114包括指示探针远侧部分定向的杆1512以及指示探针远侧末端三维位置和深度的同心圆阵列1514。 [0246] For example, in FIGS. 68A and 68B, the distal portion 114 includes an icon indicating the orientation of the probe shaft distal tip 1512 and probe indicating three-dimensional position and depth of the concentric circles 1514 arrays. 此外,包括俯仰指示器1506,所述俯仰指示器1506被实施为同心圆阵列1586,所述同心圆阵列1586被设置在与圆阵列1514相对的杆1512的一端处。 In addition, an indicator 1506 including the pitch, the pitch indicator 1506 is implemented as an array of concentric circles 1586, the array 1586 are concentrically disposed at an end opposite to the circular array of rods 1514 1512. 圆阵列1586包括与圆阵列1514的同心圆不同颜色的或实心度的同心圆。 1586 comprises a circular array concentric with a circular array of concentric circles of different colors or solid 1514 degrees. 圆阵列1586与圆阵列1514共同作用来指示探针远侧部分的俯仰。 A circular array of the circular arrays 1586 and 1514 cooperate to indicate the pitch of the distal portion of the probe. 例如,图68A描绘这样的情况,其中探针远侧末端具有基本上零俯仰,即相对于传感器50的水平姿态(attitude)。 For example, FIG. 68A depicts a case where the probe distal tip having a substantially zero pitch, i.e., with respect to a horizontal attitude (Attitude) sensor 50. 相反地,图68B描绘这样的情况,其中探针远侧部分具有向下的俯仰,所述俯仰由(如圆阵列1514的相对较少的圆所指示的)探针远侧末端的相对较深的位置相对于(如在圆阵列1586中的相对较大数量的圆所指示的)探针远侧部分的更浅、更近侧部分来指示。 In contrast, FIG. 68B depicts a case where the probe distal portion having a downward pitch, the pitch of (e.g., circular array of relatively small circle indicated by 1514) a probe distal tip relatively deep position relative to the lighter (e.g., circle 1586 in a circular array of a relatively large number indicated) the distal portion of the probe, more proximal portion indicated. 以这种方式,图标114可以向系统使用者指示俯仰。 In this manner, an icon 114 the user may indicate to the system pitch.

[0247] 图69通过将置信度指示器1508添加到图68A和68B中示出的图标114的实施方案来将上述第六维置信度水平添加到所述实施方案。 [0247] FIG. 69 is added to the confidence level of the sixth dimension confidence indicator by adding 1508 to FIGS. 68A and 68B in the embodiment illustrated embodiment 114 of the icon to the embodiment. 在本实施方案中,置信度指示器1508被实施为置信度条形图1588,其中所呈现的或实心填充的条的数量指示由系统10所确定的探针远侧位置、定向等的置信度水平(即,较少的条指示较低的置信度水平)。 In the present embodiment, the confidence indicator 1508 is implemented as a confidence bar 1588, wherein the amount of the presented article or solid fill indicates the confidence the system 10 as determined by the probe distal position, orientation, etc. level (i.e., fewer bars indicate lower confidence level). 在此描述的置信度在本文中也被称为“强度”。 Confidence described herein is also called "strength."

[0248] 这样,理解的是,本文描述的图标仅仅是可以被采用来指示留置设备或部件的位置和其他特征的各种图标指示器的实施例。 [0248] Thus, it is understood that the icons are merely described herein may be employed to indicate the various embodiments of the indwelling position of the icon pointer device or other components and features. 实际上,在其他实施方案中,其他类型的条、符号、形状、其他指示器以及指示器结构可以被采用来表征探针远侧末端的各种特征,包括本文描述的六维特征中的任何一个或更多个。 Indeed, in other embodiments, other types of bars, symbol, shape, structure and an indicator of other indicators may be employed to characterize the various features of the distal tip of the probe, including any of the six-dimensional features described herein in one or more.

[0249] 图71描绘根据一个实施方案的图标114在描绘五维探针远侧末端数据方面的另一个实施例,其中三维探针末端位置和深度信息通过图标的圆阵列1514被示出,并且第四维探针远侧部分定向通过杆1592被示出。 [0249] FIG. 71 depicts an embodiment in accordance with one embodiment of the icons 114 in another embodiment depicted in five-dimensional data front distal tip of the probe, wherein the three-dimensional position of the probe tip and the depth information is shown by circular icon array 1514, and the fourth dimension is oriented by the distal portion of the probe shaft 1592 is shown. 此外,当被描绘在显示器30上时,杆1592被给出倾斜的视角以便视觉地指示探针的远侧部分的俯仰(即,探针远侧末端信息的第五维)。 Further, when depicted on the display 30, the lever 1592 is given viewing angle tilted to visually indicate the pitch of the distal portion of the probe (i.e., probe distal tip fifth dimension information). 例如,倾斜杆1592A指示俯仰的角度是陆峭地(steeply)正的,即探针末端在z方向上陆峭地接近传感器50。 E.g., 1592a indicating the pitch angle of the tilt lever is a land to steep (steeply) positive, i.e. the probe tip in the z direction, the steep land 50 close to the sensor. 如在图71中指示的,倾斜杆1592B和1592C也描绘成正俯仰探针末端,尽管相对不太陡峭的角度。 As indicated in FIG. 71, the tilt lever 1592B and 1592C are also depicted as positive pitch probe tip, although relatively less steep angle. 倾斜杆1592D示出零俯仰,而倾斜杆1592E到1592G描绘负俯仰探针末端,即探针远侧部分在z方向上向下地远离传感器50。 Tilting lever illustrated zero pitch 1592D, 1592E and the tilt lever to depict negative pitch 1592G probe tip, i.e. the distal portion remote from the sensor probe 50 downwardly in the z direction.

[0250] 图72描绘图标114在描绘探针远侧末端的特征(比如关于所述末端的位置、定向等的不确定度水平)方面的另一个实施例。 [0250] FIG. 72 depicts another icon 114 in the distal tip of the probe characterize (for example, with respect to the end position, orientation, and other uncertainty levels) Example. 如示出的,图标114包括杆1512和固定末端图标1510。 As shown, the icon 114 includes an icon bars 1512 and 1510 fixed end. 根据在图72中被示出在相应图标的右边的由系统10所确定的不确定度水平,所述杆1512、末端图标1510或者两者可以在颜色、可视性、明暗度等方面弱化。 The level of uncertainty is shown in FIG. 72 by the system to the right of the icon 10 is determined, the rod 1512, an icon 1510 terminus or both may weaken in color, visibility, brightness and the like. 这只是当图标114被描绘在系统显示器30上时可以通过图标114表征的附加的特征的一个实施例。 This is only possible when the icon 114 is depicted in one embodiment by the additional features characterized icon 114 on the display system 30. 因此,多个方面或信息片段可以通过如本文所描述的一个或更多个图标的指示器表征。 Accordingly, aspects of the indicator or message fragments may be characterized by one or more icons, such as described herein by. 注意的是,如本文使用的,不确定度是与上面讨论的置信度的值相对的值;因此,在一个实施方案中,所述两个术语彼此相反。 Note that, as used herein, the uncertainty is the value of the confidence discussed above relative value; Thus, in one embodiment, the two terms are opposite to each other.

[0251] 注意的是,本文示出和描述的各种指示器被描绘为彼此集成的或者物理上彼此邻近/接近成组的。 [0251] Note that herein shown and described in the various indicators are depicted as physically integrated with each other or adjacent to each other / close of groups. 在另一个实施方案中,理解的是,图标的各种方面可以彼此分开被描绘。 In another embodiment, it is understood that various aspects of the icon may be depicted separately from each other.

[0252] 在图73中,示出当所述系统以上面另外提及的第三方式(即基于ECG的末端位置确认)时的显示器30的屏幕截图1600。 [0252] In FIG 73, illustrates a screen display when the system (i.e., based on the end position to confirm the ECG) in a third manner when the above-mentioned additional screenshot 1600 30. 特别地,图标114被示出,随着远侧导管末端推进通过患者的脉管系统,所述图标114表征所述远侧导管末端,被叠加在传感器50 (图64)的表征图像120之上。 In particular, the icon 114 is shown with the distal tip of the catheter is advanced through the vasculature of a patient, the icon characterizing the distal catheter tip 114, is superimposed on the sensor 50 (FIG. 64) of the representation of the image 120 . 根据一个实施方案,图标114的形状、颜色等可以根据由系统10所确定的或已知的所述末端与意图的血管内位置(比如SVC的下三分之一(1/3)部分)的邻近程度而改变。 According to one embodiment, the shape of the icon 114, color may be within the intended end position of the blood vessel (such as the lower one-third (1/3) portion of the SVC) according to the determined or known by the system 10 of the proximity of change. 图73示出,在到达意图目的地之前,图标114类似于上面讨论的图标并且包括指示探针远侧末端定向的杆1512以及指示探针末端的位置和深度的同心圆阵列1514。 FIG 73 shows, before reaching the intended destination, similar to icon 114 includes an icon indicating discussed above and orientation of probe distal tip of the rod and a concentric circle array 1512 indicates the location and depth of the probe tip 1514. 图74示出,一旦系统10已经确定导管远侧末端已经到达SVC的下三分之一(1/3)部分(或其他适合的意图目的地),定位指示器1610可以被显示,在本实施方案中所述定位指示器1610被实施为叠加在杆1512和圆阵列1514上的菱形1620。 74 shows, once the system has determined the catheter distal tip 10 has reached the lower third of the SVC (1/3) portion (or other suitable intended destination), position indicator 1610 may be displayed, in the present embodiment embodiment the position indicator 1610 is implemented as superimposed on the circular array of rods 1512 and 1514 diamond 1620. 在本实施方案中,菱形1620用绿色着色,尽管可以使用其他着色、明暗处理(shading)以及形状。 In the present embodiment, the green colored diamond 1620, although other colorants may be used, shading (Shading) and the shape. 这向观察者指示导管远侧末端被正确地安置。 This indicates to the viewer the catheter distal tip is properly positioned.

[0253] 图75示出,当导管远侧末端已经推进超过意图目的地时,定位指示器1610可以改变成叠加在杆1512和圆阵列1514上的八边形,并且用红色着色。 [0253] FIG. 75 shows, when the catheter has been advanced beyond the distal tip intended destination, position indicator 1610 may be changed to an octagonal superimposed on the circular array of rods 1512 and 1514, and red coloration. 在此图标定位指示器1610的形状和颜色暗示“停止(STOP)”交通信号来向观察者指示导管远侧末端的推进应该停止并且可能应该撤回适合的量。 In shape and color of the icon position indicator 1610 implies "stop (STOP)" traffic signals to indicate to the viewer advancing the distal tip of the catheter should be stopped and appropriate amount may be withdrawn. 在一个实施方案中,如果不存在充分的数据来描绘具有适合的置信度水平的定位指示器,灰色圆或其他适合的指示器可以被叠加在图标114上。 In one embodiment, if there is no data to sufficiently position indicator is depicted having an appropriate confidence level, gray circle or other suitable indicators may be superimposed on the icons 114.

[0254] 注意的是,结合图73-75描述的定位指示器1610,除了包括区别的颜色以外,还包括区别的形状,以使即使对于色盲观察者或者当黑白打印出时能够区别开。 [0254] Note that the position indicator 1610 described in conjunction with FIGS. 73-75, except for the color difference comprises, further comprising differentiated shape, so that even for the observer or color blindness can be distinguished when the monochrome printing. 还注意的是,上面描述的图标仅仅是可以被采用指示留置设备或部件的位置、定向等各种方面的可能的图标的较宽范围的表征。 Note also that the icons are merely described above may be characterized in a wide range of possible icons indicating various aspects of the device or component placement position, orientation, etc. employed.

[0255] —般地,请注意的是,在其他实施方案中,上面描述的一个或多个磁性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可以变化。 [0255] - camel, note that in other embodiments, one or more magnetic elements described above in not only shape, the composition, number, size, magnetic type, and the distal probe design may be varied in the segment location. 例如,在一个实施方案中,所述多个铁磁性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。 For example, in one embodiment, the plurality of ferromagnetic elements is replaced by an electromagnetic assembly, for example, a magnetic field generating electromagnetic coil is detected by the sensor. 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(Medical Instrument Locat1n Means) ” 的美国专利N0.5,099,845 中得到,本文通过引用将其全部内容并入本申请。 In another embodiment of this embodiment of the available components may U.S. Patent N0.5,099,845 "medical device positioning means (Medical Instrument Locat1n Means)" is obtained from the subject, herein by reference in its entirety is incorporated herein . 此外,包括可以与所述TSL方式一起使用的磁性元件的探针的其他实施例可以在题目为“探针仪器及制造方法(Stylet Apparatusesand Methods of Manufacture) ”的美国公开号2007/0049846中得到,本文通过引用将其全部内容并入本申请。 Further, a probe comprising a magnetic element that can be used with another embodiment of the TSL embodiments may entitled "apparatus and method for manufacturing a probe (Stylet Apparatusesand Methods of Manufacture)" U.S. Publication No. 2007/0049846 resulting in herein by reference in its entirety is incorporated herein. 因此,本发明的实施方案意图包括这些和其他变体。 Thus, embodiments of the present invention is intended to include these and other variations. 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,并且可以包括多个导丝。 It should here be understood that as used herein "probe" may be configured to include a removable manner to facilitate placement of the distal end of the catheter placed in the lumen of the catheter in a patient in the vasculature of a variety of apparatus according to any desired location and may comprise a plurality of guidewire. 附加地,理解的是,本文描述的导管放置系统可以采取许多形式并且可以包括相比于本文描述的配置变化的配置。 Additionally, it is understood that the catheter placement system as described herein may take many forms and may include a change in configuration compared to the configuration described herein. 另外,所述图标可以被采用在除了探针以外的留置医疗设备的描述的方面,或者与采用其他方式的系统一起被使用,所述系统包括基于阻抗的系统、基于压力的系统、具有变化的(例如,与除了TLS传感器的参照系以外)不同的参照系的系统等。 Further, the icons may be employed in addition to the probes described indwelling medical device, or be used with the systems of other ways, the system comprising an impedance-based systems, pressure-based systems, with varying (e.g., in addition to the TLS sensor reference frame) frame of reference different systems. 最后,理解的是,声音信号可以伴随图标在显示器上的描绘和移动。 Finally, it is understood that the icon may be accompanied by a sound signal is depicted and the movement on the display. 例如,比如在图SB中所见,在一个实施方案中,当图标在传感器图像120(图73-75)附近而不是在传感器图像120顶上(atop)时,可以听见第一声音音调,当图标被描绘在传感器图像的上半部时(比如在图73中),听见第二声音音调,当图标被描绘在传感器图像的中间部分时(比如在图74中),听见第三音调,以及当图标指示探针末端已经超过患者脉管系统内的意图目的地时(比如在图75中),听见第四音调(比如唧唧声(chirp))。 For example, as seen in FIG. SB example, in one embodiment, when the icon image sensor 120 (FIG. 73-75), rather than in the vicinity of the top of the sensor image 120 (ATOP), the first audible tone sounds, when icon is depicted in the upper half of the image sensor (as in FIG. 73), a second audible tone sounds, when the icon is depicted in the middle portion of the image sensor (as in FIG. 74), a third audible tone, and when the icon indicating the probe tip has been exceeded intended destination within a patient's vasculature (as in FIG. 75), the fourth tone heard (such as the chirp (chirp)). 注意的是,在一个实施方案中,在此描述的图标和音调被使用来追踪进一步上面描述的使用ECG方式的探针远侧末端。 Note that, in one embodiment, icons tone described herein is used to track the probe's distal tip using the ECG further embodiment described above. 因此,这些和其他与声音有关的图标被理解为落在本公开范围内。 Accordingly, these and other sound-related icons are understood to fall within the scope of this disclosure.

[0256] 本发明的实施方案可以包括具有计算机硬件的专用或通用计算机。 Embodiment [0256] of the present invention may comprise a special purpose or general purpose computer with computer hardware. 本公开的范围内的实施方案还包括用于承载或使计算机可执行指令或数据结构储存于其上的计算机可读介质。 Embodiments within the scope of the present disclosure further comprises means for causing a computer to carry or executable instructions or data structures stored thereon computer-readable medium. 这样的计算机可读介质可以为可以被通用或专用计算机访问的任何可获得的介质。 Such computer-readable media can be any available media that can be accessed by a general purpose or special purpose computer. 以实施例的方式而非限制性的,计算机可读介质可以包括物理(或可记录型)计算机可读储存介质,例如RAM、ROM、EEPROM、CD-ROM或其他光盘储存器、磁盘储存器或者其他磁性储存装置、非易失性和闪存存储器,或者可以被用来以计算机可执行指令或数据结构的形式储存期望的程序代码方法并且可以被通用或专用计算机访问的任何其他介质。 By way of example and not limitation, computer-readable media can comprise physical (or recordable type) computer-readable storage media, for example RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or any other medium other magnetic storage devices, flash memory, and a nonvolatile memory, or can be used to program code means in the form of computer-executable instructions or data structures stored desired and may be accessed by a general purpose or special purpose computer.

[0257] 在本说明书和所附的权利要求书中,“网络”被限定为在计算机系统和/或模块之间使能电子数据传输的一个或更多个数据链接。 [0257] In the claims of the present specification and the appended claims, "network" is defined as between computer systems and / or modules can enable a transmission of electronic data or more data links. 当信息在网络或另一通信连接(或者硬连线、无线或者硬连线或无线的组合)上被传输或提供至计算机时,所述计算机恰当地将所述连接视为计算机可读介质。 When information is transferred or provided to the computer over a network or another communications connection (or a combination of hardwired, wireless or hard-wired or wireless), the computer properly views the connection as a computer-readable medium. 因此,以实施例的方式而不是限制性的,计算机可读介质还可以包括这样的网络或数据链接,所述网络或数据链接可以被用来以计算机可执行指令或数据结构的形式承载或储存期望的程序代码方法并且可以被通用或专用计算机访问。 Thus, by way of example and not limitation, computer readable media may also include a network or data link, network, or the data links may be used in computer-executable instructions or data structures stored in the form of bearers or desired program code means and may be a general purpose or special purpose computer.

[0258] 计算机可执行指令包括,例如导致通用计算机、专用计算机或者专用处理装置执行特定功能或功能组的指令和数据。 [0258] Computer-executable instructions comprise, for example, cause a general purpose computer, special purpose computer, or special purpose processing device to perform specific functions and data instruction or group of functions. 计算机可执行指令可以为,例如二进制中间格式指令(如汇编语言或者甚至是源代码)。 Computer-executable instructions may be, for example, binaries, intermediate format instructions (such as assembly language, or even source code). 尽管本发明已经在语言上针对结构特征和/或方法动作进行了描述,要理解的是,限定在所附的权利要求书中的本发明无需被限定为所描述的特征或上述动作。 Although the present invention has been in language specific to structural features and / or methodological acts have been described, it is understood that, without being limited to the defining features described above or the operation of the present invention in the appended claims. 相反,所描述的特征和动作被公开为实现权利要求的示例性形式。 Instead, the described features and acts are disclosed as exemplary implementing the claims form.

[0259] 本领域技术人员将理解的是,本发明的实施方案可以在具有一种或更多种类型的计算机系统配置(包括个人计算机、桌上型计算机、膝上型计算机、消息处理器、手持装置、多处理器系统、基于微处理器的或可编程的消费性电子产品、上网PC、迷你计算机、主机计算机、移动电话、PDA、寻呼机等等)的计算环境下被实践。 [0259] Those skilled in the art will appreciate that the embodiments of the present invention may have one or more types of computer system configurations (including personal computers, desktop computers, laptop computers, message processors, hand-held devices, multiprocessor systems, microprocessor-based or programmable consumer electronics products, the practice under Internet PC, mini computer, mainframe computer, mobile phone, PDA, pager, etc.) computing environment. 实施方案还可以在本地和远程计算机系统(二者都执行任务)通过网络链接(或者通过硬连线的数据链接、无线数据链接或者通过硬连线和无线数据链接的组合)的分布式系统环境下被实践。 Embodiments may also be local and remote computer systems (both tasks) linked by a network (either by hardwired data links, wireless data links, or by a combination of hardwired and wireless data links) through a distributed system environment under the practice. 在分布式系统环境下,程序模块可以位于本地和远程存储器储存装置二者中。 In a distributed system environment, program modules may be located in both local and remote memory storage devices.

[0260] 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。 [0260] Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the invention. 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。 The described embodiments are to be considered in all respects only as illustrative, not restrictive. 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。 Accordingly, the scope of embodiments of the present invention by the appended claims rather than the foregoing specification shown. 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。 All changes which come within the scope of the claims of the meaning and equivalency range are intended to be included within the scope of the present invention.

Claims (26)

1.一种在用于在患者的身体内引导和放置医疗设备的系统中的图标,所述系统包括在所述医疗设备插入所述身体期间描绘与所述医疗设备有关的信息的显示器,所述图标用于在所述显示器上的描绘,所述图标包括: 位置指示器,所述位置指示器指示所述医疗设备的三维位置;以及至少一个附加的指示器,所述至少一个附加的指示器与所述位置指示器一起被包括,所述至少一个附加的指示器指示所述医疗设备的附加方面。 1. A system for guiding and placing the icon of the medical device within the patient's body, said system comprising a medical device depicting the display of information relating to the medical device during insertion of the body, the for depicting said icon on said display of said icons comprising: a position indicator, a position indicator indicating the three-dimensional position of the medical device; and at least one additional indicator, the indication of the at least one additional together with the position indicator is included, additional aspects of at least one additional indicator indicates the medical device.
2.如权利要求1所述的图标,其中所述医疗设备被插入所述患者的脉管系统。 2. The icons according to claim 1, wherein the medical device is inserted into the patient's vasculature.
3.如权利要求2所述的图标,其中所述医疗设备包括探针,并且其中所述位置指示器指示所述探针的远侧末端的位置。 The icons as claimed in claim 2, wherein said medical device comprises a probe and wherein said position indicator indicates a position of the distal tip of the probe.
4.如权利要求1所述的图标,其中所述医疗设备包括导管,并且其中所述图标与所述导管的远侧末端的位置相关。 4. The icon according to claim 1, wherein the medical device comprises a catheter, and wherein the position of said icon associated with the distal tip of the catheter.
5.如权利要求1所述的图标,其中所述位置指示器指示所述医疗设备相对于xyz轴坐标空间的位置。 Icon as claimed in claim 1 wherein said indicator indicates a position of the medical device with respect to the position xyz coordinate space requirements.
6.如权利要求5所述的图标,其中所述位置指示器包括多个同心圆,所描绘的多个圆的数量根据所述医疗设备在所述患者内的深度而变化。 5 icons as claimed in claim 6, wherein said position indicator comprises a plurality of concentric circles, the number of the plurality of the circle depicted vary depending on the depth of the medical device within the patient.
7.如权利要求6所述的图标,其中所述至少一个附加的指示器包括定向指示器,所述定向指示器指示所述医疗设备在所述患者的所述身体内的定向。 7. The icon according to claim 6, wherein said at least one additional indicator comprises a directional indicator, the orientation indicator indicates the orientation of the medical device within the patient's body.
8.如权利要求7所述的图标,其中所述定向指示器包括杆,所述杆被附接到所述位置指示器,所述杆的纵向延伸指示所述医疗设备的远侧部分的定向。 As claimed in claim 7 extending longitudinally icon indicating the orientation of the distal stem portion of the medical device, wherein the directional indicator comprises a lever is attached to the position indicator, .
9.如权利要求1所述的图标,其中所述至少一个附加的指示器包括定位指示器,所述定位指示器指示所述医疗设备与所述患者身体内的意图目的地的邻近程度。 9. The icon according to claim 1, wherein said indicator comprises at least one additional position indicator, the intended destination of the positioning proximity indicator indicates the body of the medical device with the patient.
10.如权利要求9所述的图标,其中所述定位指示器包括菱形和八边形中的至少一个。 10. The icon according to claim 9, wherein said position indicator comprises a diamond, and octagon least one.
11.如权利要求10所述的图标,其中所述菱形用绿色着色,并且其中所述八边形用红色着色。 11. The icon according to claim 10, wherein the green colored diamond, octagon and wherein the red coloring.
12.如权利要求1所述的图标,其中所述至少一个附加的指示器包括俯仰指示器,所述俯仰指示器指示所述医疗设备在所述患者的所述身体内的垂直俯仰。 12. The icon according to claim 1, wherein said indicator comprises at least one additional indicator pitch, the pitch indicator indicates the vertical pitch of the medical device within the body of the patient.
13.如权利要求12所述的图标,其中所述俯仰指示器包括杆,所述杆描绘一角度,所述角度与在所述患者内的所述医疗设备的倾斜的俯仰相对应。 13. The icon of claim 12, wherein the pitch indicator comprises a rod depicts an angle, the pitch angle of inclination of the medical device within the patient, respectively.
14.如权利要求1所述的图标,其中所述至少一个附加的指示器包括置信度指示器,所述置信度指示器指示由至少与所述医疗设备的位置有关的所述系统所确定的置信度水平。 14. The icon according to claim 1, wherein said at least one additional indicator includes a confidence indicator, the confidence indicator indicating the determined at least by the system on the position of the medical device confidence level.
15.如权利要求14所述的图标,其中所述置信度指示器包括条形图。 15. The icon according to claim 14, wherein the confidence indicator comprises a bar.
16.如权利要求1所述的图标,其中所述至少一个附加的指示器包括不确定度指示器,所述不确定度指示器指示由至少与所述医疗设备的位置有关的所述系统所确定的不确定度水平。 16. The icon according to claim 1, wherein said indicator comprises at least one additional indicator of the uncertainty, the uncertainty of the system associated indicator indicates at least a position of the medical device of the determine the level of uncertainty.
17.如权利要求1所述的图标,其中所述图标与由所述医疗设备的磁性元件的系统所进行的检测有关。 17. The icon according to claim 1, wherein the icon is performed by the detection system of the medical device about the magnetic element.
18.如权利要求1所述的图标,其中所述图标与由所述患者的ECG信号的系统所进行的检测有关。 18. The icon according to claim 1, wherein the icon is detected by the system and the patient ECG signal related to performed.
19.一种用于在患者的脉管系统内放置导管的方法,所述方法包括: 将所述导管导入所述患者的所述脉管系统,所述导管包括探针; 当所述导管在所述患者的所述脉管系统内时,检测所述探针的至少一个磁性元件的场;以及在显示器上描绘与所述探针有关的图标,所述图标包括: 位置指示器,所述位置指示器指示所述探针的远侧端的三维位置;以及至少一个附加的指示器,所述至少一个附加的指示器与所述位置指示器一起被包括,所述至少一个附加的指示器指示所述探针的附加方面。 19. A method for placing a catheter in the vasculature of a patient, the method comprising: the catheter into the vascular system of the patient, said catheter comprising a probe; when said catheter within the vascular system of the patient, the at least one magnetic field detecting element of the probe; and a drawing relating to the probe on a display icon, said icon comprising: a position indicator, the the position indicator indicating three-dimensional position of the probe distal end; and at least one additional indicator, at least one additional indicator together with the position indicator comprises at least one additional indicator indicates additional aspects of the probe.
20.如权利要求19所述的用于放置所述导管的方法,其中所述在所述显示器上描绘的步骤还包括在所述显示器上描绘所述图标,其中所述至少一个附加的指示器包括定向指示器,所述定向指示器指示所述探针在所述患者的所述身体内的定向。 20. wherein at least one additional indicator method as claimed for placing the catheter of claim 19, wherein said step of depicting on said display further comprises drawing the icon on the display, comprises a directional indicator, the indicator indicates the orientation of the body in the orientation of the probe to the patient.
21.如权利要求19所述的用于放置所述导管的方法,其中所述在所述显示器上描绘的步骤还包括在所述显示器上描绘所述图标,其中所述至少一个附加的指示器包括置信度指示器,所述置信度指示器指示与所述探针的所述远侧端在所述脉管系统内的实际位置有关的置信度水平。 21. wherein at least one additional indicator method as claimed for placing the catheter of claim 19, wherein said step of depicting on said display further comprises drawing the icon on the display, comprising a confidence indicator, the confidence level of confidence related to the actual position of the indicator indicates the distal end of the probe within the vascular system.
22.—种在用于在患者的身体内引导和放置导管的系统中的图标,所述系统包括在所述导管插入所述身体期间描绘与所述导管有关的信息的显示器,所述图标用于在所述显示器上的描绘,所述图标包括: 位置指示器,所述位置指示器视觉地表征与所述导管有关的三维位置;以及与所述位置指示器一起被包括的定向指示器,所述定向指示器视觉地表征与所述导管的远侧部分有关的定向。 In the system for guiding and placing a catheter within a patient's body in the icon, the system comprises a drawing 22.- species displaying information related to the catheter during the catheter into the body, the icon in the depicted on the display, the icons include: a position indicator, the position indicator visually associated with the characterization of the three-dimensional position of the catheter; and said position indicator is included with the orientation indicator, Characterization of the orientation indicator visually associated with the orientation of the distal portion of the catheter.
23.如权利要求22所述的图标,其中所述导管包括探针,并且其中所述位置和定向指示器指示所述探针的远侧部分的位置和定向,所述探针的远侧末端与所述导管的远侧末端基本上是共端头的。 23. The distal tip of the icons 22 and wherein said indicator indicates the position and orientation of the probe position and orientation of the distal portion, wherein the catheter comprises a probe, the probe and the distal tip of the catheter is substantially co-terminal.
24.如权利要求23所述的图标,其中所述位置指示器包括多个同心圆,所描绘的多个圆的数量根据所述医疗设备在所述患者内的深度而变化。 24. The icon according to claim 23, wherein said position indicator comprises a plurality of concentric circles, the number of the plurality of the circle depicted vary depending on the depth of the medical device within the patient.
25.如权利要求24所述的图标,其中所述定向指示器包括杆,所述杆被附接到所述位置指示器,所述杆的纵向延伸指示所述医疗设备的远侧部分的定向。 25. The icon 24 indicates that the longitudinally extending rod orientation of the distal portion of the medical device, wherein the directional indicator comprises a lever is attached to the position indicator, .
26.如权利要求22所述的图标,所述图标还包括与所述位置和定向指示器一起被包括的定位指示器,所述定位指示器指示所述探针的所述远侧末端与所述患者身体内的意图目的地的邻近程度。 26. The icon according to claim 22, further comprising a position indicator of the icon with the position and orientation of the indicator is included, the location indicator indicates the distal tip of the probe and the said proximity intent destinations within the patient's body.
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