CN103536998B - 管道组件 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00147—Holding or positioning arrangements
- A61B1/00158—Holding or positioning arrangements using magnetic field
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
- A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
- A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J15/00—Feeding-tubes for therapeutic purposes
- A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- A61M25/0097—Catheters; Hollow probes characterised by the hub
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A61M25/0127—Magnetic means; Magnetic markers
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- A—HUMAN NECESSITIES
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- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
- A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
- A61B5/064—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
- A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
Abstract
具有信号发生器安放控制装置的管道组件，用于与电子导管引导系统配合使用。控制装置有助于相对于管道组件的末端控制引导系统的信号发生器的位置。管道组件包括连接到控制装置一端的管状绝缘体，管道组件还包括连接到控制装置另一端的管状连接器。此外，管道组件包括连接到管状连接器的导管和连接到导管的末端构件。
Description
本申请是中国专利申请第200680006456.2号、申请日2006年1月5日、发明名称“管道组件和信号发生器的安放控制装置及其与导管引导系统结合使用的方法”的申请的分案申请。
背景技术
医生和其他医疗服务人员经常使用导管治疗患者。众所周知，导管包括插入人体内的管道。某些通过患者的鼻子或嘴巴插入的导管用于治疗胃肠道。这些导管有时称为肠导管，通常包括饲管。饲管位于胃或肠中，输液袋向患者输送营养液、液体药品或二者的混合。
其他类型的导管插入患者的静脉或动脉用于治疗心血管系统。这些导管中包括中心静脉导管、外周静脉导管和外周静脉刺穿中心静脉导管（PICC）。这些导管包括穿过患者静脉或动脉的比较小的管子。医疗服务人员使用这些导管在一段时间内向患者注射药物、麻醉品、流体或血液制品，通常是几周或更长的时间。
在使用这些已知的导管时，将导管的末端放置在人体中合适的位置非常重要。错误的放置导管尖端会伤害或危害患者。例如，如果医疗服务人员将肠导管错误地放置在患者的肺部，液体会进入肺部，造成有害后果。如果医疗服务人员将导管错误地放置在心血管系统中错误的腔中，患者会被感染或对其造成有害的阻滞。
在一些情况下，医疗服务人员使用X射线机采集关于体内导管位置的信息。使用X射线机有一些缺点。例如，这些机器大而沉重，消耗比较多的能量，并使病人暴露在比较高的辐射中。而且，这些机器由于体积庞大通常使用时不易装卸，所以他们常常安装在特定的X光室中。该房间远离患者的病房。因此，在医疗服务人员放置导管的过程中不方便找到并使用这些机器。此外，对于家庭护理的导管放置过程，不方便运输这些机器。
因此，需要克服上述每一个缺点。
发明内容
本发明通常涉及用于导管位置引导系统的管道组件。导管引导系统用于帮助引导导管到体内的位置。该系统可以在肠内、肠外或其他合适的管饲应用期间使用。
在一实施例中，导管引导系统包括连接到线组件或探针末端的信号发生器。本发明的管道组件容纳信号发生器和探针，同时信号发生器在体内。管道组件包括管状绝缘体、连接到管状绝缘体的中间连接器或联合装置、连接到联合装置的y形端口连接器，以及连接到y形端口连接器的饲管或其他导管。
中间连接器或联合装置使装配人员能方便地在导管内设定信号发生器的适当位置。联合装置的功能使设定长度的探针能与不同长度的导管配合使用。因此，与本发明的导管位置引导系统结合使用的管道组件在治疗期间有助于导管的安置。
因此本发明的一个优点是提供管道组件和信号发生器安放控制装置及其与导管引导系统共同使用的方法。
本发明的另一个优点是帮助使用者在体内恰当地安放导管的末端。
本发明的又一个优点是减少了将导管恰当地引导到体内所需空腔必要的时间。
本发明还有一个优点是减少了与协助放置导管的机器相关的辐射照射量。
本发明的另一个优点是降低了在体内安放导管导致危害的可能性。
本发明的又一个优点是简化导管安放过程的步骤。
本发明还有一个优点是提高导管安放过程的安全性。
本发明的另一个优点是使长度变化的导管适应于插入预定长度的电子探针。
本发明的又一个优点是帮助医疗服务人员引导和定位导管。
本发明的另一个优点是提高在安放导管期间和之后获取导管安放信息的便利性。
本发明的其他特征和优点在以下的具体实施方式和附图中说明，并可从中明显看出。
附图说明
图1是导管位置引导系统的透视图，说明了本发明实施例中的显示装置、电子导管单元和用于定位患者体内导管的手持收发器。
图2是导管位置引导系统的电子结构的原理框图，说明了本发明实施例中的处理器、存储装置、信号发生器、输入装置和输出装置。
图3是电子导管单元和显示装置的俯视或平面图，说明了包括插入人体内的导管的肠内应用和显示装置上导管信息的指示。
图4是电子导管单元和显示装置的俯视或平面图，说明了包括插入人体内的导管的肠外应用和显示装置上导管信息的指示。
图5是电子导管单元的透视图，说明了本发明实施例中的管道组件和插入并包裹在管道组件中的信号发生器。
图6是从管道组件移出的电子导管单元的电连接器的透视图，说明了本发明实施例中的管状连接器、联合装置、y形端口连接器、饲管和管道组件的尖端。
图7是实质上沿图5的线VII-VII剖开的容纳线组件的管状绝缘体的剖面图。
图8A是本发明实施例中联合装置的透视图。
图8B是实质上沿图8A的线VIIIB-VIIIB剖开的信号发生器位置控制装置或联合装置的剖面图。
图9是本发明实施例中联合装置的近端的俯视或平面图。
图10是y形端口连接器的透视图，说明了本发明实施例中的管饲支路、药物支路、连接支路和柔性臂。
图11是实质上沿图10的线XI–XI剖开的y形端口连接器的剖面图。
图12是本发明实施例中y形端口连接器和连接到y形端口连接器的连接支路的饲管的透视图。
图13是本发明实施例中导管的末端构件或尖端的透视图。
图14是信号发生器的透视图，说明了本发明实施例中的容纳线组件的一部分的管状绝缘体。
图15是信号发生器的电子连接器的透视图，说明了本发明实施例中连接到从外壳伸出的电延伸部分的电连接器。
图16是信号发生器的电连接器的俯视透视图，说明了本发明实施例中的上表面和下表面、电路板、电路板上的接触构件、连接到接触构件的铜线和细长的加强杆。
图17是本发明实施例中信号发生器的电连接器的仰视图。
图18是本发明实施例中信号发生器的电连接器的电路板的俯视或平面图。
图19是本发明实施例中信号发生器的透视图。
图20是磁场发生器的透视图，说明了本发明实施例中包围信号放大器的线圈。
图21是不具有本发明的挡块构件或位置控制器的电子导管的俯视或平面图，说明了不当伸出到导管开口之外的磁场发生器的示例。
图22是不具有本发明的挡块构件或位置控制器的电子导管的另一俯视或平面图，说明了信号发生器相对于导管开口不当定位的示例。
图23是不同大小的导管的俯视或平面图，说明了由于导管之间制造的差别造成了靠近导管尖端的磁场发生器的位置的不同。
图24是联合装置和管状绝缘体的透视图，说明了使用者将管状绝缘体的远端插入联合装置。
图25是联合装置和管状绝缘体的透视图，说明了使用者通过将管状绝缘体的远端安放在联合装置中的不同位置，从而调整饲管中磁场发生器的位置。
具体实施方式
I、导管位置引导系统
参考附图，在图1和图2所示的实施例中，导管位置引导系统或导管引导系统2包括：（a）具有支撑控制器或处理器20的外壳18和显示装置22的装置10；（b）通过电线、电缆、信号数据连接器或信号传送器62电连接到处理器20的非侵入式可移动接收器-发送器或收发器32；（c）将装置10连接到电源25的电源塞绳27；（d）连接到装置10的打印机28，用于打印出具有指示导管位置信息的图形；及（e）与收发器32相连并通过电线、电缆、塞绳或电延伸部分34可操作地连接到装置10的非侵入式电子导管单元12，而电线、电缆、塞绳或电延伸部分可操作地连接到处理器20。应当理解收发器32可以包括具有单独的信号接受器和信号发送器的装置。收发器32还可以包括单一装置，其运行时接收和发送信号。
如图2所示，在一实施例中，系统2包括：（a）用于向系统2提供输入信号的多个输入装置17，如一个或多个控制按钮29、触摸屏31和收发器32；（b）信号发生组件16，其产生或发生由收发器32接收的信号；（c）包括机器可读指令和一个或多个计算机程序（其中包括例如多个算法23）的存储装置21，处理器20使用这些指令和程序，以处理由信号发生组件16产生和由收发器32发送的信号数据；及（d）多个输出装置19，如向医疗服务人员指示导管信息的显示装置22和打印机28。显示装置22可以是任何合适的显示机构，包括但不限于液晶显示器（LCD）、发光二极管（LED）、阴极射线管显示器（CRT）或等离子屏幕。
医疗服务人员可以在多种导管应用中使用系统2。在图3所示实施例中，系统2用于肠内应用。在此，电子导管单元12的一部分70通过患者的鼻子或嘴72安放。电子导管单元12的远端或尖端60定位在胃部74。医疗服务人员将收发器32安放在身体78的胸部区域76之上。显示装置22和打印机28指示关于电子导管单元12的一部分70在体内的位置的信息，以及关于电子导管单元12采取的路径形状的信息。应当理解，向医疗服务人员提供帮助系统2不必须指示电子导管单元12的精确位置或路径。
在图4所示的另一实施例中，电子导管单元12的一部分71通过通向心脏75的静脉或动脉进入患者身体78。类似肠内实施例，系统2帮助医疗服务人员引导患者静脉或动脉73中的电子导管单元12的一部分71通向准备肠外管饲的心脏75中的所需空腔。
II、电子导管单元
参考图5，在一实施例中，电子导管单元12包括插入并包裹信号发生组件16的管道组件14。
A、管道组件
如图6–7所示，在一实施例中，管道组件14包括：（a）管子或管状电绝缘体40；（b）插入管状绝缘体40的中间连接器或联合装置42；（c）可连接到联合装置42的多端口连接器或y形端口连接器44；（d）连接到y形端口连接器44的导管50，如饲管；及（e）连接到导管50的远端的导管末端、推注端或尖端60。
在一实施例中，管状绝缘体40包括管子，管子具有：（a）可连接到电子导管单元12的连接构件或颈部108的近端100；（b）可由联合装置42容纳的远端102；（c）内部直径实质上等于或大于如下所述的线组件38的内部直径，从而在线组件38上滑动；及（d）外部直径106。在另一实施例中，管状绝缘体40可以比较紧密地装配在线组件38上，从而固定到线组件38。
如图8A、8B和9所示，在一实施例中，联合装置42包括：（a）近端116；（b）远端118；（c）固定在近端116与远端118之间的位置调整器、延伸器或细长颈部120；（d）靠近远端118固定的夹持或卡紧构件122，从而帮助使用者抓住和操作联合装置42；（e）靠近卡紧构件122固定的插入物124，其插入y形端口连接器44；及（f）具有防止管状绝缘体40穿过末端118的闭塞构件或挡块132的内表面126。卡紧构件122包括从卡紧构件122的表面123伸出的多个突出的壁或肋构件136，帮助使用者抓住联合装置42。在可选实施例中，卡紧构件122的表面123粗糙或包括任何合适形状的突起。
联合装置42的近端116具有内直径128和外直径130。装配时，联合装置42的近端116连接到管状绝缘体40的远端102。在一实施例中，联合装置42近端116的内直径128实质上等于或大于管状绝缘体40远端102的外直径106。参考图6，这使管状绝缘体40的远端102的一部分103能够可移动地插入联合装置42的细长颈部120。如下所述，联合装置的挡块132（具有直径133）防止管状绝缘体40的远端102穿过联合装置42的远端118。
参考图10–11，在一实施例中多端口或y形端口连接器44包括：（a）主体140；（b）连接到主体140用于向患者分配麻醉品、药品或其他药液的液体输送支路、药物输送支路或药物支路142；（c）连接到主体140且大小适于接收联合装置42的插入物124的营养输送支路或管饲支路144；（d）连接到导管50的导管或饲管连接支路146；（e）连接到主体140的柔软或可移动的臂148；及（f）连接到主体140的柔软或可移动的臂150。在可选实施例中，y形端口连接器44还包括用于管理供给人体78的不同营养和药品的额外支路。在另一可选实施例中，y形端口连接器44只包括管饲支路144和连接支路146。臂148具有塞子152，臂150具有塞子154。在塞子152和154分别塞紧支路142和144之后，塞子152和154的大小防止流体流过支路142和144。此外，臂150包括将管子尺寸适配器156固定到臂150的紧固件155。管子尺寸适配器156能适用于不同直径的流体输送管（未示出），从而连接到y形端口连接器44的管饲支路144。
如图12-13所示，在一实施例中，导管50包括具有主体160的饲管，主体160具有：（a）连接到y形端口连接器44的导管连接支路146的近端162；（b）远端164；及（c）外表面166。近端162可插入到y形端口连接器44的导管连接支路146，从而使导管50与y形端口连接器44流体连通。在一实施例中，外表面166具有沿导管的主体160均匀间隔的多个测定体积的度量或单位标记168。这些标记168帮助使用者测量流量或分配供给或来自患者的液体。在可选实施例中，标记168用作安放标记，帮助使用者评估导管在人体内安放的深度。
如图13所示，在一实施例中，末端构件、推注端或尖端60连接到导管50的远端164。尖端60包括主体172，主体172具有颈圈174和末端构件176。主体172限定通道178和开口180。开口180定位在颈圈174与末端构件176之间。末端构件176的一部分177可以是圆形。通道178和尖端60的开口180的形状设置为便于流体从导管50流到患者体内，同时降低开口180堵塞的可能性。
管状连接器40、联合装置42、y形连接器44、导管和尖端60由任何合适的聚合物和塑料材料制成，包括但不限于聚酰胺、聚乙烯、聚丙烯、聚氨酯、硅酮和聚丙烯腈。
B、信号发生组件
如图14-21所示，在一实施例中，侵入式信号发生组件16包括：（a）可操作地连接到电延伸部分34的控制器连接器或电连接器36；（b）可操作地连接到电连接器36的细长线组件38；（c）连接到连接器36并用作线组件38的支撑的线或细长加强杆39；（d）可操作地连接到线组件38的远端的磁能发生器或磁场发生器58；及（e）将细长加强杆39的远端连接到磁场发生器58的适当紧固件。上述的管状绝缘体40覆盖靠近电连接器36固定的线组件38的一部分41。
1、电连接器
如图16-18所示，在一实施例中，电子或电连接器36包括：（a）上壁或上表面186；（b）连接到上表面186的侧壁或侧面188；（c）连接到侧壁188的下壁或下表面189；（d）固定在上表面186与下表面189之间的电子引线组件或电子连接器190，如电路板191；及（e）将上表面186连接到下表面189的紧固件192和194。紧固件192和194可以是机械的或化学的。机械紧固件可以包括例如搭钩、螺钉、铆钉或其他合适的紧固件。化学紧固件可以包括例如粘合剂、化学粘合、焊接粘合或适用于将上表面186和下表面189固定在一起的铸模。虽然在图16所示实施例中具有多个穿过电路板191的紧固件192和194，但应当理解在其他实施例中单一的紧固件也可以将电路板191牢固地固定在两个表面186与189之间。
一实施例中，电路板191包括：（a）延伸穿过电路板190的一部分193的接触构件196和198；及（b）延伸穿过电路板190的预备接触构件200。接触构件196、198和200都由导电材料制造。当电子连接器190连接到电延伸部分34时，接触构件196、198和200可操作地连接到系统2的装置10。因此，接触构件196和198将来自装置10的电流发送到上述磁能发生器或磁场发生器58。
2、线组件
如图16、18和21所示，在一实施例中，线组件38包括：（a）细长的柔软导体，如近端206连接到电路板190、远端251连接到磁场发生器58的铜线202；及（b）另一细长的柔软导体，如近端212连接到电路板190、远端253连接到磁场发生器58的铜线204。铜线202的近端206可操作地连接到电路板191的接触构件196的延伸部分197。同样地，铜线204的近端212可操作地连接到电路板191的接触构件198的延伸部分199。铜线202和204可以焊接到合适的接触构件196和198，或通过任何适当的紧固件连接。
在下述实施例中，铜线202和204的远端251和253具有形成线圈250的线圈构造，因此形成如下所述的磁场发生器58。通过在如下所述的磁场发生器58的周围缠绕铜线204的一部分249产生多个螺旋，形成线圈248。
参考图18，铜线202和铜线204沿长度210和216相互缠绕，以形成绞合的构造217。在一实施例中铜线202和204沿长度210和216绞合适当的次数。绞合构造217减小沿绞合的长度210和216围绕在铜线202和204周围的任何电磁场。铜线202和204的电磁场相互抵消造成了这种减小。因此，即使存在线组件38产生的任何电磁场引起的信号干扰，手持收发器32接收到的也很少。
如图18所示，在一实施例中，细长的加强杆包括弯曲或中心部分228。细长的加强杆优选使用钢制造，但是也可以由其他任何合适的材料制造。细长加强杆39的中心部分228环绕电连接器36的紧固件192，形成一段230和一段232。段230和232相互缠绕，形成绞合构造234。绞合构造234提高细长加强杆的刚性。在一实施例中，线组件38缠绕在绞合构造234的凹槽219中。这提高了固定在管道组件14中的线组件38和细长加强杆39的空间效率。空间效率的提高是减小线组件38的整体直径110的结果，如图7所示。
3、信号发生器
如图20所示，在一实施例中，信号发生器或磁场发生器58通过铜线202和204的多个螺旋或线圈250形成。由于装置10发送电流流过铜线202和204，电流穿过线圈205限定的圆环路径。电流的圆环运动产生电磁场、B场或电磁辐射258。虽然所示实施例包括作为磁场发生器58的线圈250，但是应当理解磁场发生器58可以包括任何合适的产生或发生磁能或磁场的替代机构或装置。在一实施例中，磁场发生器58包括磁体，如永磁体、电阻磁体或超导磁体。
操作中，当装置10向线圈250发送电流时，线圈250发出能够被非侵入式收发器32检测到的信号或电磁场258。处理器20使显示装置22和打印机28产生帮助医疗服务人员进行导管安放过程的图形。
C、控制安放信号发生器的方法
如图21-25所示，如果导管组件300不具有本发明联合装置42的挡块构件132和位置调整器或控制器120，会产生一些困难。例如，导管过程可以涉及将导管50的尖端60定位到所需的位置。在导管50的制造过程中，导管可能会有范围在1-1/4英寸的长度差V1、V2和V3。在一实施例中，导管由聚氨酯材料制成，其在制造期间或之后能使导管伸长或缩短，因此导致了长度差。如果一根导管过长，磁场发生器58可能穿出尖端60，如图21所示。如果一根导管过短，磁场发生器58可能实质上没有到达尖端60就停止了，如图22所示。这会导致本发明的位置引导系统2提供的信息和图形的可靠性降低。
当磁场发生器58固定在或靠近导管50的尖端60时，系统2更有用。这样的定位有助于保持由系统2提供的引导信息具有足够的可靠性。在如图1–20和图23–25所示的实施例中，联合装置42帮助将磁场发生器58的位置维持在或靠近尖端60。在这样的实施例中，使用联合装置42降低了磁场发生器58穿出尖端60或实质上没有到达尖端60就停止的可能性。因此联合装置42用作磁场发生器安放的控制装置。在一实施例中，联合装置42的安放和控制功能能够调整以适应不同长度的导管50。
如图24–25所示，联合装置42具有近端116、远端118和位置控制器、位置调整器或细长的颈部120。近端116可移动地连接到管状绝缘体40的远端102。位置调整器或细长的颈部限定提供联合装置42的位置调整功能或调整装置的通道134。使用者能够可调整地将管状绝缘体40的第二端102固定到沿通道134的多个不同位置138（L1-L3）。一旦使用者确定适当的位置138，使用者将管状绝缘体40固定到在所选位置的调整器120。固定位置可以使用粘合剂、夹子、扣钩、带子或其他任何合适的紧固件。因为管状绝缘体40连接到电连接器36，而电连接器又连接到磁场发生器58，将管状绝缘体40紧固到位置调整器120上的适当位置有助于相对于导管50的尖端60恰当地固定磁场发生器58。这一点允许使用者相对于不同长度的导管50的末端构件或尖端60将磁场发生器58固定在所需或指定的位置。因此，使用者能够按照制造出的不同长度的导管使用系统2。
在一实施例中，控制安放磁场发生器58的方法包括第一步确定导管50的长度。下一步，在将导管50放入人体内用于肠内或肠外管饲时，使用者或装配者在导管50内所需的位置放置磁场发生器58。最后，装配者通过使用适当的粘合剂将管状绝缘体40固定到联合装置42，从而锁定安放位置。
一旦磁场发生器的位置恰当设定，医疗服务人员将收发器放置在患者的胸部上并将导管50插入体内。在这样做的同时，显示装置22显示帮助使用者将导管尖端60引导到人体内所需位置的图形37。一旦导管50放置在所需位置，使用者移走信号发生组件16，同时保持导管50的位置。使用者再将药物和营养输送管连接到y形端口连接器44，用于将流体引入身体进行医学治疗。
还应当理解在可选实施例中本发明的电子导管单元12不需要包括上述的磁场发生器位置控制装置。在此，装配者可以测量每一个导管并忽略每一个过长或过短的导管。应当理解其他组装方法或机制可以用于相对于导管尖端60控制磁场发生器58的适当位置。
应当理解本发明的管道组件、电子导管单元和导管位置引导系统可以用于多种导管过程和应用。这些过程包括治疗胃肠道、心血管系统和人体的其他部分。这些过程涉及进行治疗的医生、医生助手、护士或其他医疗服务人员。此外，这些过程涉及兽医、研究者或其他人员治疗其他哺乳动物和动物。
在一实施例中，本发明包括用于导管位置引导系统的电子导管单元的管道组件和信号发生器。管道组件和信号发生器与系统的其他元件配合使用以帮助使用者进行导管安放过程。管道组件具有使系统与不同长度的导管共同使用的位置控制器。因此，与本发明的导管位置引导系统配合使用的管道组件和位置控制器能促进医学治疗。
应当理解对在此所述的当前优选实施例所做的不同变化和修改对本领域的技术人员显而易见。这样的变化和修改不脱离本发明的精神和范围，不减少本发明的优点。因此这样的变化和修改视为在权利要求的保护范围内。
Claims (26)
1.管道组件，所述管道组件与具有连接器的信号发生器、磁场发生器和至少一将连接器连接到磁场发生器的细长电导体配合使用，细长电导体具有直径，管道组件包括：
具有第一端、第二端、内直径和外直径的管状绝缘体，管状绝缘体的第一端连接到连接器，内直径等于或大于细长电导体的直径；
联合装置，该联合装置具有第一端和第二端，联合装置的第一端和第二端中的每一个具有内直径和外直径，联合装置的第一端连接到管状绝缘体的第二端，联合装置的第一端的内直径等于或大于管状绝缘体第二端的外直径；
紧固件，其将管状绝缘体固定到联合装置上的使用者可选择的位置；
具有多个末端的多路连接器，末端的第一端连接到联合装置的第二端；
具有第一端和第二端的导管，导管的第一端连接到多路连接器的末端的第二端；及
连接到导管第二端的末端构件。
2.根据权利要求1所述的管道组件，其中联合装置包括固定在联合装置的第一与第二端之间的细长颈部。
3.根据权利要求1所述的管道组件，其中联合装置包括固定在联合装置的第一与第二端之间的夹紧构件。
4.根据权利要求1所述的管道组件，其中联合装置包括位置控制器。
5.根据权利要求1所述的管道组件，其中联合装置包括挡块。
6.根据权利要求1所述的管道组件，其中多路连接器具有药物支路、管饲支路、连接支路和多个可移动的臂。
7.根据权利要求1所述的管道组件，其中导管包括具有沿导管均匀间隔的多个指定单位标记的外表面。
8.根据权利要求1所述的管道组件，其中末端构件包括具有颈圈的第一部分和圆形的第二部分，第一部分限定通道和开口。
9.电子导管，所述电子导管与具有连接器的侵入式信号发生器、可操作地连接到连接器的至少一细长电导体、可操作地连接到连接器的电线加强杆、可操作地连接到该至少一细长电导体的磁场发生器，以及将电线加强杆连接到磁场发生器的紧固件配合使用，所述至少一细长电导体和电线加强杆形成电线组件，所述电线组件具有直径，所述电子导管包括：
具有第一端、第二端、内直径和外直径的管状绝缘体，所述第一端可连接到连接器，内直径实质上等于或大于所述电线组件的直径；
具有第一端、第二端、细长颈部、夹紧构件、插入物和内表面的联合装置，联合装置的第一端连接到管状绝缘体的第二端，内表面具有挡块，细长颈部、夹紧构件和插入物固定在联合装置的第一与第二端之间，联合装置的第一和第二端每一个具有内直径和外直径，联合装置的所述第一端的内直径实质上等于或大于管状绝缘体第二端的外直径；
限定药物支路、管饲支路、连接支路和多个可移动臂的y形端口连接器，管饲支路的大小适于接收联合装置的插入物，每一个可移动臂具有塞子；
饲管包括具有第一端、第二端和外表面的主体，所述饲管的主体的所述第一端连接到y形端口连接器的连接支路，外表面具有沿饲管主体均匀间隔的多个指定单位的标记；及
连接到饲管第二端的尖端，尖端包括具有颈圈和末端构件的主体，尖端的主体限定通道和开口，开口固定在颈圈与末端构件之间，末端构件的一部分是圆形。
10.根据权利要求9所述的电子导管，其中紧固件将管状绝缘体固定到细长颈部上使用者可选择的位置上。
11.根据权利要求9所述的电子导管，其中联合装置的夹紧构件包括多个肋构件。
12.根据权利要求10所述的电子导管，其中细长颈部和紧固件包括位置控制器。
13.根据权利要求12所述的电子导管，其中紧固件包括粘合剂。
14.管道组件，所述管道组件与：(a)具有连接器的侵入式信号发生器；(b)磁场发生器；及(c)至少一将连接器连接到磁场发生器的细长电导体配合使用，管道组件包括：
具有连接到连接器的第一端和第二端的管状绝缘体，所述第一端可连接到连接器；
具有第一端、第二端和固定在联合装置的第一端与联合装置的第二端之间的颈部的联合装置，联合装置的所述第一端可移动地连接到管状绝缘体的第二端，所述颈部限定通道，管状绝缘体的第二端可调整地固定到沿通道的多个不同位置，从而磁场发生器可相对于任意一个饲管的末端构件固定在所需位置；
在不同位置之一将管状绝缘体固定到颈部的紧固件；
限定多个支路的多路连接器，多路连接器的支路的第一支路可连接到联合装置的第二端；及
多个饲管之一，所述多个饲管的每一个具有末端构件和不同的长度。
15.根据权利要求14所述的管道组件，其中紧固件包括从由粘合剂、夹子、钉子和带子构成的组中选出的装置。
16.根据权利要求14所述的管道组件，其中联合装置包括具有多个肋构件的夹紧构件。
17.根据权利要求14所述的管道组件，其包括管子尺寸适配器。
18.根据权利要求17所述的管道组件，其中多路连接器具有至少一个可移动臂，其中可移动臂的至少一段与管子尺寸适配器接合。
19.根据权利要求14所述的管道组件，其包括与多路连接器流体连通的导管。
20.一种导管引导系统，包括：
磁场发生器；
具有第一端和第二端的管状绝缘体；
具有第三端、第四端和限定位于所述第三与第四端之间的通道的颈部的联合装置，所述联合装置的第三端可移动地连接到管状绝缘体的第二端，所述管状绝缘体的第二端可调整地固定到沿通道的多个不同位置，从而磁场发生器可固定在所需位置；
连接到所述联合装置的所述第四端的多路连接器；
连接到所述多路连接器的导管，所述导管配置为容纳磁场发生器。
21.根据权利要求20所述的导管引导系统，其中联合装置包括夹紧构件。
22.根据权利要求20所述的导管引导系统，其中联合装置包括位置控制器。
23.根据权利要求20所述的导管引导系统，其中联合装置包括挡块。
24.根据权利要求20所述的导管引导系统，其中多路连接器具有药物支路、管饲支路、连接支路和多个可移动的臂。
25.根据权利要求20所述的导管引导系统，其中导管包括具有沿导管均匀间隔的多个指定单位标记的外表面。
26.根据权利要求20所述的导管引导系统，包括连接到导管的末端构件，末端构件包括具有颈圈的第一部分和圆形的第二部分，第一部分限定通道和开口。
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| CN2006800064562A CN101460093B (zh) | 2005-01-13 | 2006-01-05 | 管道组件和信号发生器的安放控制装置及其与导管引导系统结合使用的方法 |
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| US20160001043A1 (en) | 2016-01-07 |
| CN101460093A (zh) | 2009-06-17 |
| US20110230828A1 (en) | 2011-09-22 |
| US20170128701A1 (en) | 2017-05-11 |
| WO2006076214A2 (en) | 2006-07-20 |
| AU2006205232B2 (en) | 2012-02-23 |
| US20060173407A1 (en) | 2006-08-03 |
| US9131956B2 (en) | 2015-09-15 |
| US9579488B2 (en) | 2017-02-28 |
| EP1835960A4 (en) | 2009-10-21 |
| CN101460093B (zh) | 2012-07-04 |
| CA2594734C (en) | 2012-04-24 |
| JP2008532569A (ja) | 2008-08-21 |
| CN103536998A (zh) | 2014-01-29 |
| US9889277B2 (en) | 2018-02-13 |
| EP1835960A2 (en) | 2007-09-26 |
| EP1835960B1 (en) | 2016-05-04 |
| AU2006205232A1 (en) | 2006-07-20 |
| US20180117285A1 (en) | 2018-05-03 |
| US10549074B2 (en) | 2020-02-04 |
| US7976518B2 (en) | 2011-07-12 |
| WO2006076214A3 (en) | 2008-11-20 |
| CA2594734A1 (en) | 2006-07-20 |
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