CN102985004A - 供神经监护和电外科使用的接口模块 - Google Patents

供神经监护和电外科使用的接口模块 Download PDF

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CN102985004A
CN102985004A CN2011800218966A CN201180021896A CN102985004A CN 102985004 A CN102985004 A CN 102985004A CN 2011800218966 A CN2011800218966 A CN 2011800218966A CN 201180021896 A CN201180021896 A CN 201180021896A CN 102985004 A CN102985004 A CN 102985004A
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凯文·L·麦克法林
约翰·C·布鲁斯
大卫·C·哈克尔
罗伯特·A·塔克
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Abstract

在本文中提出的概念涉及可电联接至电刺激发生器、射频发生器以及仪器的接口模块。选择模块联接至接口模块，并且在第一模式下操作，以向仪器传递来自电刺激发生器的电刺激信号，以及在第二模式下向仪器传递来自射频发生器的射频信号。

Description

供神经监护和电外科使用的接口模块
背景技术
电生理学监护帮助外科医生在隐蔽的手术野内找出神经位置所在，以及在手术过程中实时保护和评估神经功能。为此，常常采用神经完整性监护来监护肌电图（EMG）活动。在神经完整性监护过程中，检测电极或记录电极联接至适当的组织（例如，受感兴趣的神经、周围神经、脊髓、脑干等支配或控制的脑肌（cranial muscle）），以检测EMG活动。刺激，例如电刺激或机械刺激，可引起组织的兴奋。在电刺激过程中，刺激探针在受治疗神经可能所在的区域附近施加刺激信号。如果刺激探针接触神经或非常接近神经，则所施加的刺激信号传输通过神经，以刺激受支配的组织。在机械刺激中，直接物理接触适当的组织可引起组织的兴奋。在任何情况下，相关组织的兴奋均产生由记录电极（或其它检测装置）检测的电脉冲。
记录电极以信号的形式将所检测的电脉冲信息告知外科医生，以在确定EMG活动时起解释作用。例如，可将EMG活动显示在监视器上和/或可以以听觉形式呈现。
对于包含或涉及神经组织、肌肉组织或神经元电位的记录的大量的不同外科手术或评估来说，神经完整性监护是有用的。例如，各种头部和颈部外科手术（例如腮腺切除术和甲状腺切除术）要求定位并识别脑神经和周围运动神经。在某些情况中，利用电外科单元来执行这些外科手术。目前的电外科单元包括导电端头或针，导电端头或针用作通过联接至患者的接地电极接通的电路中的一个电极。通过向端头应用电能源（最常见的是射频发生器）来完成组织的切割。当将端头应用到组织之后，产生电压梯度，从而在接触点产生电流并引起相关联的生热。利用足够高强度的电能，所产生的热足以切开组织，并有利地同时烧灼切口的血管。
由于电外科单元所产生的电能的强度，用于神经完整性监护的系统当在电外科手术中使用时受到大量电干扰。电干扰可产生错误的神经元（神经组织）或肌原性（肌肉组织）信号。例如，在EMG监护过程中，电外科活动可产生人为现象（例如，假阳性），以及在神经完整性监护系统中引发相对数量的噪声。因此，目前的技术涉及到在电外科手术过程中利用探针来消减神经完整性监护系统的所有通道的噪声。因此，在电外科单元的操作过程中，通常暂停EMG活动的监护。为了使外科医生阻止利用电外科单元切割神经，外科医生将切割一短暂周期，然后停止切割，使得可恢复神经完整性监护。如果未检测到EMG活动，那么外科医生可切割另一短暂周期，同时间歇中止，以恢复神经完整性监护，以便防止切割神经。重复该过程，直到外科医生完成电外科手术。若在电外科手术过程中不能监护EMG活动，则电外科手术可能是棘手并耗时的。
发明内容
在本文中提出的概念涉及可电联接至电刺激发生器、射频发生器以及仪器的接口模块。选择模块联接至接口模块，并且在第一模式下操作，以向仪器传递来自电刺激发生器的电刺激信号，以及在第二模式下向仪器传递和/或禁止来自射频发生器的射频信号。
附图说明
图1是选择性地向仪器传递电刺激信号和射频信号的接口模块的示意方块图。
图2是包括联接至神经完整性监护系统的接口模块和电外科单元的手术系统的示意方块图。
具体实施方式
图1是仪器10的示意方块图，仪器10用于选择性地将自电刺激发生器12和射频（RF）发生器14接收的信号应用于外科手术中感兴趣的组织。接口模块16电联接至刺激发生器12和RF发生器14，以在多种模式下选择性地操作，从而将期望的输出传递至仪器10。具体地，接口模块16包括电联接至电刺激发生器12的第一输入16a、电联接至RF发生器14的第二输入16b以及电联接至仪器10的输出16c。
选择模块（例如开关或网络）18联接至接口模块16，并操作，以选择性地将电刺激发生器12和RF发生器14所分别提供的电刺激信号和RF信号之一传递至仪器10。具体地，选择模块18被配置为或者接通第一电刺激电路20，或者接通第二RF电路22。因而，当仪器10与患者的组织接触，并且电刺激电路20接通时，来自电刺激发生器12的电刺激信号被传递至组织。可替代地，当RF电路22接通时，来自RF发生器14的射频信号被传递至组织。接口模块16可进一步联接至记录电极，记录电极可提供表示仪器10和神经或肌肉之间的接触的信号。
仪器10可以为与患者电交互以执行神经监护和/或电外科的任何仪器。在一个实施例中，仪器10可为双极镊子、腹腔镜（laproscopic）双极仪器或单极烧灼笔。在任何情况下，仪器10可包括整体的神经刺激探针以及适于所期望的应用（例如手术）的作用端头。
在一个实施例中，电刺激发生器12是可来自佛罗里达州杰克逊维市美敦力公司（Medtronic Xomed,Inc.）的NIM-响应
Figure BDA00002331366900031
3.0神经监护系统的一部分，并且被配置为将电刺激信号传递至仪器10，以便刺激与仪器10接触的组织。在一个实施例中，由电刺激发生器12提供的电刺激信号的强度足够高，以刺激相关联组织，然而本质上是安全的，从而防止对相关联组织的物理创伤。
在一个实施例中，RF发生器14可为电外科单元（ESU）的一部分，电外科单元被配置为例如通过切割、烧灼和止血来处理组织。示例ESU为通过科罗拉多州博得市的威利、乔治亚州玛利埃塔市的ERBE、纽约州尤蒂卡市的康美公司、马萨诸塞州绍斯伯勒市的捷锐士ACMI以及犹他州德雷珀市的麦高迪获得。根据需要，RF发生器14可被配置为实现各种不同的组织效应。在一个实施例中，RF发生器被配置为用于在不同的电压电平下以500至3300KHz之间的频率传递信号。
接口模块16使电刺激发生器12和RF发生器14结合在一起。为此，接口模块16可被配备为接收来自电刺激发生器12、RF发生器14和仪器10的电缆。根据需要，接口模块16可进一步被配备为接收来自其它装置的输入和/或向其它装置提供输出。
选择模块18可采用包括手动开关、电开关或电网络的多种形式，来选择性地导向和传递来自电刺激发生器12和RF发生器14的信号。在一个实施例中，选择模块18可为直接结合在仪器10中的机械开关，使得用户在操作仪器10时可容易选择将向仪器10发送什么信号。例如，仪器10可包括具有选择模块18的手柄，选择模块18保持在手柄内。在该实施例中，在仪器10和接口模块16之间提供双向式通信，使得选择模块18通知接口模块16待发送至仪器10的期望信号。在另一实施例中，选择模块18可直接联接至接口模块16。示例机械开关包括锅盖开关（dome switch）、摇臂开关、拨动开关等。在又一实施例中，选择模块18可为电开关。电开关可被配置为使到仪器10的信号交错，以便例如通过在短时间范围（例如毫秒）周期性地将传递至仪器10的信号切换为交替模式（alternating pattern），来向用户呈现来自电刺激发生器12和RF发生器14的信号是同时的。在另一实施例中，接口模块16继续将电刺激信号和射频信号合并且导向输出信号中。在又一实施例中，选择模块18可由机械开关和电开关的组合来形成。例如，当机械开关确定是否向仪器10发送来自RF发生器14时，电开关可持续将电刺激信号交错到被发送至仪器10的输出信号内。在又一实施例中，选择模块18可为电网络，该电网络被配置为选择被传递至仪器10的信号，例如随着信号的频率的改变来选择，或者可替代地，将电刺激信号和RF信号合并为输出信号。
在又一实施例中，接口模块16可能够具有两种、三种或更多种操作模式。例如，RF发生器14当用作电外科单元时可提供多种不同的操作信号。在一个具体实施例中，这些RF信号被配置为用于切割和凝结。在这种情况中，接口模块16可被配置为在三种单独的模式下操作，即电刺激模式（由此传递来自电刺激发生器12的刺激信号）、RF切割模式（由此传递来自RF发生器14的切割信号）以及RF凝结模式（由此传递来自RF发生器14的凝结信号）。
在又一实施例中，接口模块16可包括默认的操作模式。例如，当用户未主动选择所期望的操作模式时，接口模块16可被配置为传递来自电刺激发生器12的信号。如上所论述的，来自电刺激发生器12的信号在本质上是安全的模式下操作，该模式未向接触仪器10的组织提供物理创伤。通过利用用于传递电刺激的默认模式，可防止向仪器10意外传递RF信号。在可替代的默认模式下，接口模块16防止任何信号被传送至仪器10。在又一实施例中，当指示仪器10靠近和/或接触神经时，接口模块16可阻止从电刺激发生器12发送的信号。
在任何情况下，选择模块18用于选择性地接通电刺激电路20或RF电路22。为此，电路20和22可被配置为不同模式，例如单极、双极和/或它们的组合。例如，在单极模式下，电路20可包括联接至患者的组织的一个或多个记录电极。当电路20接通时，电流从电刺激发生器12流过接口模块16并到达与组织接触的仪器10。然后电流从接触仪器10的点流过组织并到达联接至一个或多个记录电极的点。
然后电流从记录电极返回流到电刺激发生器12。在可替代实施例中，仪器10可为双极仪器，该双极仪器包括两个电极，一个用作作用电极，一个用作返回电极。在这种情况下，电流从电刺激发生器12通过接口模块16流向仪器10的作用电极。然后，电流从接触作用电极的点流过组织并到达接触返回电极的点，并通过返回电极、仪器10、接口模块16流回到电刺激发生器12。类似地，RF电路22在单极配置下可包括联接至组织的色散板，和/或仪器10在双极配置下可包括多个电极，以便通过患者的组织接通电路22。
图2是利用图1所示的部件的具体实施来选择性地执行内部靶向组织部位“T”处的神经监护和电外科的外科环境的示意性方块图。在一个实施例中，在腹腔镜下接近内部靶向组织部位“T”，并且利用例如来自加利福尼亚塞涅维尔市的直觉外科（Intuitive Surgical）的DaVinci机器人的外科机器人来进行外科手术。在这种情况下，仪器10为联接至外科机器人并能够受机器人控制的腕状仪器。电刺激发生器包含在神经监护系统24内，并且RF发生器14包含在电外科单元（ESU）26内。如上所述，接口模块16通过输入16a和16b即联接至神经监护系统24又联接至电外科单元26。接口模块16还通过输出16c联接至仪器10。选择模块18可操作联接至接口模块18，以指示待传递至仪器10的期望信号，以便选择性地接通电路20和22（被示意性示出）。
概括地，神经监护系统24被配置为帮助并进行人体解剖学的几乎任何神经/肌肉组合的神经完整性监护，以及记录神经电位。系统24包括可采取各种各样形式的控制单元30，在一个实施例中，系统24包括控制台40和患者接口模块50。ESU 26生成发送至手术仪器10的电流，用于切割或处理患者的组织。
系统24包括一个或多个传感探针52，传感探针52可以是例如电极的任何类型的传感装置，并且在单极配置下可操作接通电路20。在腹腔镜手术环境中，传感探针52可通过例如套管、套针等合适的导引器联接至患者内部的组织。控制单元30有利于刺激仪器10，并处理仪器10、传感探针52以及其它部件（未示出）在使用过程中所产生的所有信息。仪器10和控制单元30适于实现对传递至仪器10的刺激能量以及由此由仪器10所传递的刺激程度的控制和改变。此外，控制单元30处理从仪器10和/或传感探针52接收的由所传递的刺激所产生的信息（例如患者响应）。
利用传感探针52，系统24响应于仪器10所传递的电流能量和/或组织的物理处理而基于所记录的EMG活动执行监护。在图2的一个实施例情况下，控制台40和患者接口模块50被提供为通过电缆54通信联接的单独部件。可替代地，可采用无线链接。此外，控制台40和患者接口模块50可被提供为单个装置。然而，基本上，患者接口模块50用于促使刺激/感觉部件（例如仪器10和传感探针52）易于连接，以及用于管理输入和输出的电信号。而控制台40按照来自仪器10的控制信号解释输入信号（例如由传感探针52检测到的脉冲）、显示用户所期望的信息、提供信号的听觉反馈、呈现用户界面（例如通过包括例如触摸屏）并向仪器10传递刺激能量（通过到患者接口模块50的连接），以及所需的其它任务。
如上所述，患者接口模块50通过电缆54与控制台40传输至仪器10和来自仪器10的信息以及来自传感探针52的信息。实际上，患者接口模块50用于将患者（例如组织部位“T”处）连接至控制台40。为此，在一个实施例中，患者接口模块50包括一个或多个（优选为8个）感觉输入56，例如电联接的成对电极输入，以接收来自传感探针52（图2所一般引用的）的信号。另外，患者接口模块50提供刺激器输入端口58（图2所一般引用的）和刺激器输出端口60（图2所一般引用的）。刺激器输入端口58接收来自仪器10的关于所期望的刺激程度和/或其它活动的控制信号，而刺激器输出端口60有利于将来自电刺激发生器12的刺激能量传递至仪器10。患者接口模块50可进一步提供例如接地（或返回电极）插座的附加部件端口、用于附加的刺激器探针组件的辅助端口等等。
传感探针52联接至患者（例如所选择的组织），以向患者接口模块50提供信号。在一个实施例中，多个探针52包括电联接至感觉输入56的8个探针。在正常操作中，探针52检测来自患者的电信号并将信号发送至患者接口模块50。这些信号包括来自患者组织的电脉冲，电脉冲表示患者中的EMG活动（例如生物电响应）。当检测到仪器10靠近和/或接触神经而产生EMG活动（例如作为来自ESG12和/或ESU 26的信号的结果）时，传感探针52可向接口模块16提供一指示，接口模块16将停止将来自ESU 26的所有其它信号通过仪器10传输到组织部位“T”。因此，通过自动停止ESU 26的操作（例如通过抑制其信号）可防止对组织部位“T”中的神经的损伤。在进一步实施例中，接口模块16可进一步提供传感探针52正检测到EMG活动的警报（例如听觉和/或视觉信号）。
ESU 26可被配置为执行各种电外科模式，例如单极、双极和/或它们的组合。此外，ESU 26可被配置为传递不同类型的RF信号，以便实现所期望的组织效应。为此，根据所需，可通过接口模块16向仪器10应用各种波形和/或功率设置。另外，仪器10可装配有针对来自ESU 26的信号的特定应用所需的端头。
在进一步实施例中，放置一个或多个照相机60，以便提供手术部位的视觉信息，来帮助外科医生进行所期望的外科手术。一个或多个照相机60在腹腔镜下也可被引入到部位“T”。来自一个或多个照相机60的视频数据可与来自控制台40的视频数据一起被提供至监视器62。为此，为外科医生提供手术部位的视觉信息以及表示来自传感探针52和/或仪器10的所记录响应的视觉信息。通过选择性地提供刺激信号和RF信号，外科医生通过使用监视器62可在视觉上检查靶向部位是否是神经、或者是否可发送RF信号来切割靶向组织。因而，外科医生可迅速辨别并切割靶向组织。
尽管参照优选实施例描述了本公开，但本领域技术人员应认识到，在不脱离本公开的精神和范围的情况下，可以在形式和细节上作出变化。

Claims (27)

1.一种供电刺激发生器和电外科单元使用的接口模块，该接口模块包括：
被配置为接收来自所述电刺激发生器的电刺激信号的第一输入端；
被配置为接收来自所述电外科单元的射频信号的第二输入端；
被配置为将输出信号传递至仪器的输出端；以及
联接至所述第一输入端、所述第二输入端以及所述输出端的选择模块，其中所述选择模块被配置为选择所述电刺激信号和所述射频信号中之一作为输出信号并将所述输出信号传递至所述输出端。
2.根据权利要求1所述的接口模块，其中所述选择模块为机械开关。
3.根据权利要求1所述的接口模块，其中所述选择模块为电开关。
4.根据权利要求3所述的接口模块，其中所述电开关持续将电刺激信号和射频信号交错到所述输出信号中。
5.根据权利要求3所述的接口模块，其中所述电开关持续将电刺激信号和射频信号合并且导向所述输出信号中。
6.根据权利要求1所述的接口模块，其中所述选择模块为电网络。
7.根据权利要求1所述的接口模块，其中所述选择模块联接至所述仪器。
8.根据权利要求1所述的接口模块，其中所述射频信号被配置为用于组织的凝结。
9.根据权利要求1所述的接口模块，其中所述射频信号被配置为用于组织的切割。
10.一种在靶向部位处的组织上进行操作的手术方法，包括：
将仪器电联接至电刺激发生器和射频发生器；以及
操作选择模块，以选择性地将来自所述电刺激发生器的电刺激信号和来自所述射频发生器的射频信号中之一提供至所述仪器。
11.根据权利要求10所述的手术方法，进一步包括：
将来自所述电刺激发生器的电刺激信号传递至所述仪器。
12.根据权利要求10所述的手术方法，进一步包括：
将来自所述射频发生器的射频信号传递至所述仪器。
13.根据权利要求10所述的手术方法，进一步包括：
将电刺激信号和射频信号交错为被传递至所述仪器的交替模式。
14.根据权利要求10所述的手术方法，进一步包括：
利用联接至所述组织的记录电极记录来自组织的响应，所述响应是通过电刺激信号传递至所述组织而产生的。
15.根据权利要求10所述的手术方法，其中所述射频信号包括被配置为凝结组织的凝结信号。
16.根据权利要求10所述的手术方法，其中所述射频信号包括被配置为切割组织的切割信号。
17.根据权利要求10所述的手术方法，进一步包括：
在第一时间周期期间接通包括所述电刺激发生器和所述仪器的第一电路；
断开所述第一电路；以及
在断开所述第一电路之后的第二时间周期期间接通包括所述射频发生器和所述仪器的第二电路。
18.根据权利要求10所述的手术方法，进一步包括：
在第一时间周期期间接通包括所述电刺激发生器和所述仪器的第一电路；
断开所述第一电路；
利用联接至所述组织的记录电极记录来自组织的响应，所述响应是通过电刺激信号传递至所述组织而产生的；以及
基于所述响应停止更多射频信号的应用。
19.一种在靶向部位处的组织上使用的手术系统，包括：
仪器；
被配置为生成电刺激信号的电刺激发生器；
被配置为生成射频信号的电外科单元；
电联接至所述仪器、所述电刺激发生器以及所述电外科单元的接口模块；
包括所述仪器、所述电刺激发生器和所述接口模块的第一电路；
包括所述仪器、所述电外科单元和所述接口模块的第二电路；以及
电联接至所述接口模块并被配置为选择性地接通所述第一电路和所述第二电路中之一的选择模块。
20.根据权利要求19所述的手术系统，其中所述仪器是双极镊子、腹腔镜双极仪器、单极烧灼笔和腕状仪器中之一。
21.根据权利要求19所述的手术系统，其中所述选择模块联接至所述仪器。
22.根据权利要求19所述的手术系统，其中所述选择模块电联接至所述接口模块，并被配置为断开所述第二电路。
23.根据权利要求19所述的手术系统，其中所述选择模块电联接至所述接口模块，以提供表示所述靶向部位处的电活动性的信号。
24.根据权利要求19所述的手术系统，进一步包括联接至所述组织且被配置为记录来自所述组织的响应的一个或多个记录电极，所述响应是由传递至所述组织的电刺激信号产生的，并且其中所述一个或多个记录电极形成所述第一电路的一部分。
25.根据权利要求19所述的手术系统，进一步包括联接至所述组织且被配置为记录来自所述组织的生物电响应的一个或多个来自ESU电极的记录电极，所述响应用于断开所述第二电路。
26.根据权利要求19所述的手术系统，进一步包括联接至组织且被配置为记录由传递至所述组织的电刺激信号产生的生物电响应的一个或多个记录电极。
27.根据权利要求19所述的系统，其中所述电外科单元被配置为向所述仪器既传递切割信号又传递凝结信号。
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