CN109414274B - 具有用于神经刺激的双侧钳口配置的医疗装置 - Google Patents

具有用于神经刺激的双侧钳口配置的医疗装置 Download PDF

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CN109414274B
CN109414274B CN201780039945.6A CN201780039945A CN109414274B CN 109414274 B CN109414274 B CN 109414274B CN 201780039945 A CN201780039945 A CN 201780039945A CN 109414274 B CN109414274 B CN 109414274B
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jaw
end effector
probe
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energy
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CN109414274A (zh
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D·C·耶茨
J·D·梅瑟利
C·D·麦克莱恩
P·K·夏尔斯
F·埃斯特拉
C·R·诺特
F·B·斯图伦
C·A·帕帕
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Ethicon Endo Surgery LLC
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Abstract

本公开的各个方面呈现了一种单一外科器械，该单一外科器械被配置成能够通过施加治疗能量来抓紧、密封和/或切割组织，并且还通过施加非治疗电能来检测神经。一种医疗装置，该医疗装置可包括在端部执行器处的两个钳口，该钳口用于施加治疗能量并执行外科规程。治疗能量可为超声振动或更高电压电外科能量的形式。钳口中的一个可被配置成能够通过施加刀片来切割组织。此外，两个钳口中的一者或两者均可被配置成能够施加用于神经刺激探测的非治疗能量。可在施加非治疗神经刺激能量时禁用治疗能量的施加，并且反之亦然。可施加该非治疗神经刺激能量来使用定位在钳口中的一者或两者附近的一个或多个探针。

Description

具有用于神经刺激的双侧钳口配置的医疗装置
相关申请的交叉引用
本专利申请要求于2016年5月3日提交的标题为MEDICAL DEVICE WITH ABILATERAL JAW CONFIGURATION FOR NERVE STIMULATION的美国临时专利申请序列号62/331,123的35 U.S.C.§119(e)的优先权，该临时专利申请的全部公开内容据此以引用的方式并入本文。
技术领域
本公开整体涉及具有用于抓紧、切割和密封组织的各种机构的医疗装置。具体地，本公开涉及具有抓紧器械的医疗装置，该抓紧器械使用同一装置中的一个或多个探针中的非治疗能量进行神经刺激。
背景技术
在外科过程中，用于切割和密封组织的能量诸如超声振动或电外科能量可能损害不旨在操作的某些身体组织，尽管其存在于手术部位。例如，与以外科和治疗水平施加的能量接触，神经可能受损。另一方面，施加到神经上或接近神经(例如约2mm)的低水平的能量可引起相关肌肉的可见振动以警示外科医生它们的存在。此可见指示可为外科医生提供足够的信息来安全地执行外科手术，同时避免微妙的神经末梢。传统上，外科医生可因此利用多个装置来执行外科手术，诸如通过向神经刺激探针施加更低电压来检测神经的一种装置以及通过施加超声或更高电压治疗能量来抓紧、密封和/或切割组织的另一种装置。可能期望利用一种外科工具，其施加治疗能量(例如超声或更高电压电外科能量)，并且还包括神经感测能力，诸如单一装置中小心地定位的更低电压神经刺激探针，以允许更安全和更有效的外科规程。
尽管已研制和使用了若干装置，但据信在本发明人之前还无人研制出或使用所附权利要求中描述的装置。
发明内容
在多个方面，提供一种外科器械。
1.在一个示例中，提出一种外科器械，该外科器械包括：第一钳口柄部和第二钳口柄部，所述第一钳口柄部和第二钳口柄部围绕接合部枢转地联接；该第一钳口柄部在该第一钳口柄部的远侧端部处包括第一钳口；该第二钳口柄部在该第二钳口柄部的远侧端部处包括第二钳口；当该第一钳口柄部和该第二钳口柄部围绕该接合部枢转地旋转到闭合位置时，该第一钳口和该第二钳口被配置成能够抓紧两者间的组织；该第一钳口和该第二钳口中的至少一者被配置成能够递送更高能量水平的治疗能量，以用于密封或切割手术部位处的组织；并且该第一钳口和该第二钳口中的至少一者被配置成能够递送更低能量水平的非治疗能量，以用于向手术部位处的神经组织提供电刺激。
2.在示例1的外科器械的另一个示例中，治疗能量包括超声能量。
3.在示例1的外科器械的另一个示例中，治疗能量包括高频电外科能量。
4.在示例1的外科器械的另一个示例中，第一钳口和第二钳口两者均被配置成能够将非治疗能量递送到手术部位处的组织，并且其中在第一钳口和第二钳口两者处均递送的非治疗能量处于相同的电势。
5.在示例1的外科器械的另一个示例中，第一钳口和第二钳口中的至少一者在所述钳口的内部部分上包括绝缘材料，使得在闭合位置中第一钳口通过接触绝缘材料的方式来接触第二钳口。
6.在另一示例中，提出一种外科器械，该外科器械包括：柄部组件；以及端部执行器，该端部执行器以能够通信的方式联接到柄部组件并包括第一钳口和第二钳口，该柄部组件被配置成能够操纵该第一钳口和第二钳口，以限定打开位置和闭合位置；并且该端部执行器被配置成能够：递送更高能量水平的治疗能量，以用于密封或切割手术部位处的组织；并且递送更低能量水平的非治疗能量，以用于向手术部位处的神经组织提供电刺激。
7.在示例6的外科器械的另一个示例中，端部执行器还包括电刺激探针，该电刺激探针被配置成能够递送非治疗能量，以刺激手术部位处的神经组织。
8.在示例7的外科器械的另一个示例中，电刺激探针是可回缩的，并且还被配置成能够在朝向柄部组件的近侧方向上回缩并在远离柄部组件的远侧方向中伸展。
9.在示例7的外科器械的另一个示例中，端部执行器还包括返回探针，其中当返回探针和电刺激探针两者均接触手术部位处的组织时，电刺激探针和返回探针完成电路，并且其中返回探针充当非治疗能量的电回路。
10.在示例7的外科器械的另一个示例中，电刺激探针被配置成能够基本上靠近端部执行器的第一侧形成轮廓，该端部执行器的第一侧包括由第一钳口和第二钳口限定的端部执行器的远侧末端的第一部分。
11.在示例10的外科器械的另一个示例中，端部执行器还包括返回探针，所述返回探针被配置成能够基本上靠近端部执行器的与第一侧相对的第二侧形成轮廓，该端部执行器的第二侧包括由第一钳口和第二钳口限定的端部执行器的远侧末端的第二部分，其中当返回探针和电刺激探针两者均接触手术部位处的组织时，电刺激探针和返回探针完成电路。
12.在示例6的外科器械的另一个示例中，端部执行器还包括第一电突起探针，该第一电突起探针被配置成能够联接到第一钳口或第二钳口的远侧端部并被配置成能够递送非治疗能量，以刺激手术部位处的神经组织。
13.在示例12的外科器械的另一个示例中，其中端部执行器还包括第二电突起返回探针，该第二电突起返回探针被联接到第一钳口或第二钳口的远侧端部并被配置成能够当第一探针和第二探针两者均接触手术部位处的组织时与第一电突起一起完成电路。
14.在示例6的外科器械的另一个示例中，外科器械还包括联接到柄部组件的远侧端部和端部执行器的近侧端部的轴，该轴被配置成能够将端部执行器电联接到柄部组件。
15.在另一示例中，提出一种外科系统，该外科系统包括：柄部组件；电力发生器，该电力发生器电联接到柄部组件；以及端部执行器，该端部执行器以能够通信的方式联接到柄部组件并电联接到电力发生器并包括第一钳口和第二钳口，该柄部组件被配置成能够操纵该第一钳口和第二钳口，以限定打开位置和闭合位置；该端部执行器被配置成能够：选择性递送更高能量水平的治疗能量，以用于密封或切割手术部位处的组织；并且选择性递送更低能量水平的非治疗能量，以用于向手术部位处的神经组织提供电刺激；电力发生器被配置成能够：生成将被传递到端部执行器的更高能量水平的治疗能量；并且生成将被传递到端部执行器的更低能量水平的非治疗能量。
16.在示例15的外科系统的另一个示例中，端部执行器还包括电刺激探针，该电刺激探针被配置成能够递送非治疗能量，以刺激手术部位处的神经组织。
17.在示例16的外科系统的另一个示例中，电刺激探针是可回缩的，并且还被配置成能够在朝向柄部组件的近侧方向上回缩并在远离柄部组件的远侧方向中伸展。
18.在示例16的外科系统的另一个示例中，端部执行器还包括返回探针，其中当返回探针和电刺激探针两者均接触手术部位处的组织时，电刺激探针和返回探针完成电路。
19.在示例16的外科系统的另一个示例中，电刺激探针被配置成能够基本上靠近端部执行器的第一侧形成轮廓，该端部执行器的第一侧包括由第一钳口和第二钳口限定的端部执行器的远侧末端的第一部分。
20.在示例15的外科系统的另一个示例中，端部执行器还包括返回探针，所述返回探针被配置成能够基本上靠近端部执行器的与第一侧相对的第二侧形成轮廓，该端部执行器的第二侧包括由第一钳口和第二钳口限定的端部执行器的远侧末端的第二部分，其中当返回探针和电刺激探针两者均接触手术部位处的组织时，电刺激探针和返回探针完成电路。
21.在示例18中的外科系统的另一个示例中，治疗能量是单极的并且返回探针进一步充当治疗能量的电气回路。
上述发明内容仅为例示性的，并非旨在以任何方式进行限制。除了上述例示性方面和特征，参考附图和下述详细说明，其它方面和特征将变得显而易见。
附图说明
本文所述方面的新颖特征在所附权利要求书中进行了详细描述。然而，关于组织和操作方法两者的这些方面可结合如下附图参考下述说明更好地理解。
图1示出根据各种方面的可配置成能够具有神经刺激和治疗功能两者的医疗装置。
图2示出根据一些方面的被配置成能够递送治疗能量和非治疗能量的外科器械的替代性设计。
图3示出根据一些方面的包括外科器械的钳口旁边的神经刺激探针的替代性设计。
图4示出图3中所示的可回缩探针的侧视图。
图5示出根据一些方面的柄部组件处的回缩机构的操纵图3和图4的可回缩探针的部分。
图6示出根据一些方面的包括外科器械的钳口轮廓旁边的神经刺激探针的另一种替代性设计。
图7示出根据一些方面的图6的周边探针配置的侧视图。
图8示出根据一些方面的包括钳口处的神经刺激、包括电突起探针和返回突起探针的另一种替代性设计。
图9示出根据一些方面的包括外科装置中的神经刺激、包括使刀片能够供应治疗能量和非治疗能量两者的另一种替代性设计。
图10是根据一些方面的外科系统的框图，该外科系统包括具有马达驱动部件的抓紧器械以向手术部位施加能量，该外科器械联接到发生器有线刺激源(或者另选地具有内部发生器)。
图11示出根据一些方面的基于电容式开关的按钮。
图12示出根据一些方面的神经刺激系统1200的一个方面。
具体实施方式
在下述详细说明中，参考构成其一部分的附图。在附图中，除非上下文另外指出，否则类似的符号和参考字符通常在几个视图中标识相似的部件。详细说明、附图和权利要求书中所述的例示性方面并非旨在为限制性的。可利用其它方面，并且可做出其它改变，此并不偏离此处所呈现的主题的范围。
下面对本技术的某些示例的描述不应用于限制本技术的范围。从下面的描述而言，本技术的其它示例、特征、方面和优点对本领域的技术人员而言将变得显而易见，下面的描述以举例的方式进行，这是为实现本技术所设想的最好的方式中的一种方式。正如将意识到的，本文所述的技术能够具有其他不同的和明显的方面，所有这些方面均不脱离本技术。因此，附图和说明应被视为实质上是例示性的而非限制性的。
还应当理解，本文所述的教导内容、表达、方面、示例等中的任何一个或多个可与本文所述的其它教导内容、表达、方面、示例等中的任何一个或多个相结合。因此，下述教导内容、表达方式、方面、实施例等不应视为彼此孤立。参考本文的教导内容，本文的教导内容可进行组合的各种合适方式对于本领域的普通技术人员而言将显而易见。此类修改和变型旨在包括在权利要求书的范围内。
而且，在下述说明中，应当理解，例如前、后、内部、外部、顶部、底部等术语是方便的言语，并且不应当理解为限制性术语。本文所用的术语并非意在限制在本文所述装置或其部分的范围内，而是可以按照其他取向附接或利用。将参照附图更详细地描述各种方面。在整个公开内容中，术语“近侧”用于描述部件例如轴、柄部组件等的更接近于操作外科器械的使用者例如外科医生的侧面，并且术语“远侧”用于描述部件的距离操作外科器械的使用者更远的侧面。
呈现了本公开的单一外科器械的方面，该单一外科器械被配置成能够通过施加治疗能量(例如超声和/或更高电压电外科能量)来抓紧、密封和/或切割组织，并且还通过施加非治疗电能来检测神经。常规地，至少两种医疗装置可用于执行这些动作的组合。然而，可见性可通过具有挤进手术部位的多个装置来减小，使得如果单个装置可执行所有前述功能，则使其可能更不安全。此外，如果多个器械在手术部位中交替进出以重复执行不同的功能，则外科医生的精确度可能会受损害。
本文所述的各种特征部可以并入到电外科装置中以出于治疗目的将电能施加到组织以便治疗和/或破坏组织，也发现在外科规程中的逐渐增加的广泛应用。电外科装置通常包括手持件、具有远侧安装的端部执行器(例如，一个或多个电极)的器械。所述端部执行器可抵靠组织定位，使得电流被引入组织中。电外科装置可被构造用于双极或单极操作。在双极操作期间，电流分别通过端部执行器的有源电极和返回电极被引入组织中并从组织返回。在单极操作过程中，电流通过端部执行器的有源电极引入组织中并且通过单独位于患者身体上的返回电极(例如，附接到或邻近患者手术部位远侧的位置并且通过导电粘合剂电容地或直接地电联接到患者的接地垫或弥散电极)来返回。流过组织的电流所产生的热可在组织内和/或在组织之间形成止血密封，并因此可尤其适用于例如密封血管。电外科装置的端部执行器也可包括能够相对于组织运动的切割构件以及用以横切组织的电极。
在一些方面，医疗装置包括在端部执行器处的两个钳口，该钳口用于施加治疗能量并执行抓紧、密封和/或切割规程。端部执行器可形成于轴的远侧端部处，轴的近侧端部以能够通信的方式联接到柄部组件。在其它情况下，端部执行器可形成于剪刀状配置的一对夹持臂的末端处。钳口中的一者或两者均可被配置成能够供应治疗能量，诸如呈超声振动或更高电压电外科能量形式。在一些方面，钳口中的一个可被配置成能够通过施加刀片来切割组织。此外，两个钳口中的一者或两者均可被配置成能够施加用于神经刺激探测的非治疗能量，诸如施加更低振幅电能。在一些方面，可在施加非治疗神经刺激能量时禁用治疗能量的施加，并且反之亦然。在一些方面中，可施加该非治疗神经刺激能量来使用定位在钳口中的一者或两者附近的一个或多个探针。
由电外科装置施加的电能可通过与柄部组件连通的发生器传递至器械。电能可为射频(“RF”)能量的形式。RF能量为可在200千赫兹(kHz)至1兆赫兹(MHz)频率范围内的电能形式。在应用中，电外科装置可穿过组织传递低频射频能，这会引起离子振荡或摩擦，并实际上造成电阻性加热，从而升高组织的温度。由于受影响的组织与周围组织之间形成明显的边界，因此外科医生能够以高精确度进行操作，并在不损伤相邻的非目标组织的情况下进行控制。射频能的低操作温度适用于在密封血管的同时移除、收缩软组织、或对软组织塑型。RF能量尤其奏效地适用于结缔组织，所述结缔组织主要由胶原构成并且在接触热时收缩。
参见图1，示出根据各种方面的可配置为具有神经刺激和治疗功能两者的医疗装置100。医疗装置100在远侧端部处包括两个钳口116a和116b，以限定端部执行器114，两个钳口均分别单独地连接到钳口臂162a和162b。钳口柄部164a和164b分别在近侧端部处联接到钳口臂162a和162。钳口116a和116b可枢转地连接在接合部168处，从而允许钳口夹紧和/或抓紧它们之间的组织。在一些方面，钳口116a和116b中的一者或两者均可被配置成能够通过各种装置诸如超声能量、高频电外科能量、电阻加热元件、微波等将治疗能量递送到接触组织。在一些方面，在臂中的一个中可包括激活开关、辊或按钮160以调节治疗能量的程度。
此外，医疗装置100可被配置成能够在钳口116a和160b中的一者或两者处均递送非治疗神经刺激探测能量。这种能量可以低频率或电压形成，以便当钳口116a和116b在该模式下与组织接触时不损害任何神经或其它组织。在一些方面，钳口两者均可被配置成能够递送非治疗探测能量以产生双侧神经刺激配置。刺激源170可电联接到医疗装置100，诸如通过能量端口166a和166b，以通过两个钳口柄部164a和164b供应探测能量。两个钳口均可接收相同电势的能量。然后可通过钳口116a和116b将能量施加到患者102，如箭头150所示。电刺激路径可通过使用例如皮下针形探针、患者接地夹线或患者接地垫来完成。因此，当处于该配置时，医疗装置100可被配置成能够检测钳口116a和/或116b何时接近手术部位处的任何神经。例如，这种接触或几乎接触(例如约2mm)神经的能量的施加可能导致神经的可见振动，以向外科医生指示是否存在神经。
在一些方面，通过这种类型的刺激定位神经可通过任何三种期望的使用模式来实现。在一种情况下，可通过由钳口116a和116b的末端进行探测来查探神经。即，如果钳口116a和/或116b的末端位于其上或其附近(例如，约1-5mm)，则神经或其它非肌肉组织可抽搐或振动。在具有约0.5mA刺激输出的测试中，通常在传导构件(钳口116a和/或116b的末端)位于或接触紧邻(小于约1mm)神经的神经或接触组织时刺激神经。同样，在2mA刺激输出的情况下，通常当导电构件接触距离神经约2至5mm的邻近神经时刺激神经。第二种情况包括夹持组织以检测神经。钳口116a或116b中的一个的至少一个内部夹持表面被配置成能够施加神经刺激能量。第三种情况包括通过展开解剖进行检测。通过扩大钳口来展开组织可用至少一个外部表面检测神经，该外部表面被配置成能够主动地施加非治疗神经刺激能量。在其它配置中，这些使用模式中的多于一种可在医疗装置100中实现。
在一些方面，钳口116a和116b可为电隔离的，甚至当钳口处于闭合位置中或正在抓持组织时也如此。绝缘销可放置在钳口116a或116b中的至少一者的内部，使得钳口仅接触绝缘销。在其它情况下，绝缘带或其它非导电材料可定位在钳口116a或116b的一者或两者周围，使得钳口仅接触绝缘带或其它非导电材料。这样，可分配足够的物理空间以允许超声振动隔离或者在其它情况下允许电隔离，如可与双极电外科钳口一起使用。
图2示出根据一些方面的被配置成能够递送治疗能量和非治疗能量至手术部位的外科器械200的替代性设计。根据一些方面，器械200可包括触发器组件107和用于在端部执行器110处闭合钳口116a和116b的闭合系统布置，该闭合系统布置包括弹簧驱动凸轮闭合机构。弹簧驱动凸轮闭合系统被配置成能够闭合一组相对钳口116a,116b，并且在一些情况下，在端部执行器110中击发切割元件。触发器组件107被配置成能够夹紧并击发联接到外科器械200的轴组件112的端部执行器110。外科器械200还包括柄部组件104、轴组件112和端部执行器110。轴组件112包括近侧端部和远侧端部。轴组件112的近侧端部联接到柄部组件104的远侧端部。端部执行器110联接到轴组件112的远侧端部。柄部组件104包括手枪式握把118。柄部组件104包括左柄部外壳罩106a和右柄部外壳罩106b。触发器组件107包括可朝向手枪式握把118致动的触发器109。可旋转轴旋钮120被配置成能够相对于柄部组件104旋转轴组件112。柄部组件104还包括能量按钮122，该能量按钮122被配置成能够向端部执行器110中的一个或多个电极提供治疗电外科能量。轴组件112包括闭合/钳口致动器、击发/切割构件致动器和外部护套。在一些方面，外部护套包括闭合致动器。外部护套包括被配置成能够与端部执行器110交接的在远侧端部上的一个或多个接触电极。一个或多个接触电极可操作地联接到能量按钮122、组织密封物模式选择组件108和刺激源170。
能量源可适用于治疗组织治疗、组织烧灼/密封以及子治疗处理和测量。能量按钮122控制能量到电极的递送。装置200还被配置成能够在一些情况下通过钮子开关或按钮诸如通过第二次按压能量按钮122来切换到在端部执行器110处施加非治疗能量，以切换到神经刺激模式。在其它情况下，单独的按钮或开关激活诸如通过旋转旋钮120进入特定取向或按压另一个按钮(未示出)可允许激活神经刺激能量。刺激源170可被配置成能够生成一种或两种模式的能量。能量生成波形的附加示例细节将在下文中更详细地描述。
应当理解，在情况适当时，使用者可选择治疗或诊断输出，或者系统可选择治疗或诊断输出。
如整个公开内容中所使用，按钮是指用于控制机器或工艺的一些方面的开关机构。该按钮可以由硬质材料通常诸如塑料或金属制成。该表面可形成或成形来容纳人体手指或手，以便容易地按压或推送。按钮可为最通常的偏压开关，尽管许多未偏压按钮(由于其物理性质)需要弹簧返回其未推送状态。术语“推动”按钮可包括按压、压下、捣压和冲压。
图11示出根据本公开的一些方面的基于电容式开关的按钮。在其它方面，该按钮可基于光断续器技术。返回图11，示出电容式触摸开关系统1100。电容式触摸开关1100包括位于印刷电路板基板1110上方的电绝缘盖板1106。导电垫1108通常由铜或其它导电金属形成。当手指1102接触盖板1106并且手指电容1104在手指1102与位于盖板1106下方的导电垫1108之间形成时，形成电容式触摸开关1100。手指电容1104通过人的身体联接到地电位。当手指1102与盖板1106接触时，手指电容1104与垫电容1112平行，该垫电容1112联接到位于系统中其它位置的地电位1114。电容式触摸开关系统1100是可如何实现示例外科装置中采用的按钮的一个示例。
重新参照图2，在某些方面中，端部执行器110联接到轴组件112的远侧端部。端部执行器110包括第一钳口构件116a和第二钳口构件116b。第一钳口构件116a枢转地联接到第二钳口构件116b。第一钳口构件116a相对于第二钳口构件116b可枢转地运动以抓紧两者间的组织。在一些方面，第二钳口构件116b是固定的。在其它方面，第一钳口构件116a和第二钳口构件116b可枢转地运动。端部执行器110包括至少一个电极。电极被配置成能够递送电外科能量。由电极递送的能量可包括例如射频(RF)能、亚治疗RF能量、超声能量和/或其它合适形式的能量。在一些方面，切割构件(未示出)可接纳在由第一钳口构件116a和/或第二钳口构件116b限定的纵向狭槽内。切割构件被配置成能够切割在第一钳口构件116a与第二钳口构件116b之间抓紧的组织。在一些方面，切割构件包括用于递送能量，例如RF和/或超声能量的电极。
参见图3，图示300示出根据一些方面的包括钳口116a和116b旁边的神经刺激探针的替代性设计。在此，示出可回缩探针配置。图示300示出从顶部视图角度查看的医疗装置100的一部分，在此示出顶部钳口116a和对应的钳口臂162a。图示300中的这种配置包括可延伸超过钳口116a的远侧端部的两个均可回缩探针302和304，正如所示。探针可由形状记忆材料制成，以便允许探针在其设计或形状方面略微修改，以根据手术部位的几何形状按照需要使用。间隙306存在于探针302与304之间，使得在探针302和304的端部接触组织时，电流的返回路径可能完成。在这种情况下，第二探针304充当返回电极。在其它方面，可提供单一电极，并且在其中或附近的皮下针或分散电极可充当返回电极。
参见图4，图示400示出图示300中所示的可回缩探针302和304的侧视图。在该配置中，在304处的探针302位于钳口116a和116b上方。在其它情况下，探针可位于钳口下方或侧面，并且各方面并未如此限制。从该视图中，可明显看出，探针302和304可在方向R中回缩到钳口臂162b中，正如所示。
参见图5，图示500示出根据一些方面的操纵图示300和400所示的可回缩探针的回缩机构的部分。此处，钳口柄部164b的一部分包括用于滑动回缩机构的狭槽502以操纵可回缩探针302和304(参见图3)。在这种情况下，旋钮或开关可被配置成能够在狭槽502内来回滑动以回缩并延伸探针302和304。在其它情况下，可回缩探针可通过未示出的轮回缩机构操纵。无论如何，钳口柄部164b可包括电流振幅控制开关504，以控制施加到端部执行器处的探针的电流水平。
参见图6，图示600示出根据一些方面的包括钳口116a和116b旁边的神经刺激探针的另一种替代性设计。在此情况下，探针602和604定位在钳口116a的周边周围，并且被成形为符合端部执行器的轮廓。图示600从医疗装置的顶视图示出这种配置。类似于图3中的配置，探针602和604通过间隙分开，在此情况下包括该间隙中的垫片608。因此，垫片608可固定到钳口116b的远侧端部，以便稳定探针602和604的位置或者以其它方式防止移动干扰。一旦组织接触探针602和604两者，就可再次封闭电流路径，其中该电流路径在箭头606的方向中行进。因此，探针604可充当返回电极。
参见图7，图示700示出根据一些方面的图示600的周边探针配置的侧视图。在此，显示探针602和604定位在钳口116b和钳口柄部162b的一部分的周边上。当结合图示600和700的视角时，可能清楚的是，探针602和604符合钳口周边的轮廓。以这种方式，被配置成能够通过钳口供应治疗能量的现有医疗装置可简单地被重构或改装成包括沿着钳口的周边运行的一对电极或探针，以形成无缝且非侵入的神经刺激特征部。
参见图8，图示800示出根据一些方面的包括钳口116a和116b处的神经刺激的另一种替代性设计。此处，钳口116b的远侧端部处的两个小电极突起802和804可用于神经刺激和定位。突起中的一个可充当刺激探针，而另一个突起可充当返回电极。通向探针802和804的电路可穿过钳口向下延伸至钳口116b的远侧端部。虽然探针802和804被示出并定位在钳口116b的外部和底部，但是这些探针可定位在其它配置中。例如，探针802和804可定位成面向钳口116b或116a的远侧端部的前部。又如，探针802和804可定位在钳口116a的顶部上。在其它情况下，两组探针可定位在钳口的远侧端部处，一对定位在钳口116a和116b的每一个上。
参见图9，图示900示出根据一些方面的包括夹持医疗装置中的神经刺激的另一种替代性设计。此处，钳口904中的一个可充当探针和夹具两者和/或刀片。即，在刀片904的一种模式中，可施加治疗能量以执行各种切割或密封规程。在第二种模式中，可激活刀片904以提供非治疗能量以便定位和/或刺激神经。在一些情况下，夹持钳口902可充当返回电极，而在其它情况下，皮下针或分散电极可充当返回电极。此外，可清楚的是，图示900中的此替代性设计可与如图3-8中所讨论的可回缩探针、周边探针或末端电极配置组合。
图10是根据一些方面的外科系统1000的框图，该外科系统1000包括具有马达驱动部件的抓紧器械100(图1)以向手术部位施加能量，该外科器械联接到发生器有线刺激源(或者另选地具有内部发生器1005)。可使用马达1030来闭合和打开端部执行器110的钳口116a,116b中的一者或两者(图2)或者击发刀。然而，在大多数方面，此类功能将手工操作。外科系统1000示出抓紧器械的内部电路的部件，并且还可描述替代性抓紧器械200的内部电路(图2)。本公开所述的马达驱动外科器械100可联接到有线刺激源170，诸如发生器(或另选地内部发生器1005)，该刺激源170被配置成能够通过外部或内部装置向外科器械提供电力。虽然先前的附图描述了抓紧、密封、切割和探测部件的结构的示例，但图10描述了治疗能量和非治疗能量可如何递送到端部执行器的部分的示例。在某些情况下，马达驱动的外科器械100可包括联接到外部有线发生器170或内部发生器1005的微控制器1010。外部发生器170或内部发生器1005还可联接A/C电源，或者可以是运行的电池或它们的组合。与马达驱动外科器械100和/或发生器元件170,1005相关联的电动和电子电路元件可例如由控制电路板组件支撑。微控制器1010通常可包括存储器1015和可操作地联接到存储器1015的微处理器1020(“处理器”)。处理器1020可控制马达驱动器1025电路，该电路通常用于控制马达1030的位置和速率。马达1030可被配置成能够控制能量到外科器械的端部执行器处的电极的传输。在某些情况下，处理器1020向马达驱动器1025发送信号，以停止或停用马达1030，如下文更详细地描述。在某些情况下，处理器1020可控制单独的马达超控电路，该电路可包括马达超控开关，该马达超控开关可在操作外科器械的过程中，响应于来自处理器1020的超控信号而停止和/或停用马达1030。应当理解，本文使用的术语“处理器”包括任何合适的微处理器、微控制器，或者将计算机的中央处理单元(CPU)的功能结合到一个集成电路或最多几个集成电路上的其他基础计算装置。处理器是多用途的可编程装置，该装置接收数字数据作为输入，依据其存储器中存储的指令来处理输入，然后提供结果作为输出。因为处理器具有内部存储器，所以是顺序数字逻辑的示例。处理器的操作对象是以二进制数字系统表示的数字和符号。
在一些情况下，处理器1020可以是任一种单核或多核处理器，诸如已知的由TexasInstruments生产的商品名为ARM Cortex的那些。在一些情况下，本公开的任何外科器械可包括安全处理器，例如包括两个基于微控制器的系列(诸如TMS570和RM4x)的安全微控制器平台(已知同样由Texas Instruments生产的商品名为Hercules ARM Cortex R4)。然而，可不受限制地采用微控制器和安全处理器的其他合适的替代物。在一个示例中，安全处理器可被配置成能够专门用于IEC 61508和ISO 26262安全性至关重要的应用、以及其它应用，以提供先进的集成安全特征结构，同时提供可缩放性能、连接性和存储器选项。
在某些情况下，微控制器1010可以是例如可购自Texas Instruments的LM4F230H5QR。在至少一个示例中，Texas Instruments LM4F230H5QR是ARM Cortex-M4F处理器内核，包括高达40MHz的256KB单周期闪速存储器或其它非易失性存储器的芯片上存储器1015、40MHz以上的用于提高性能的预取缓冲区、32KB单周期串行随机存取存储器(SRAM)、加载有
Figure BDA0001923132710000141
软件的内置只读存储器(ROM)、2KB电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、一个或多个具有12个模拟输入通道的12位模/数转换器(ADC)、以及随时可用于产品数据表的其它特征结构。可容易地取代其它微控制器，以用于马达驱动的外科器械100。因此，本公开不应限于这一上下文。
再次参见图10，外科系统1000可包括例如有线刺激源170。在某些情况下，有线刺激源170可被配置成能够在通过外部装置，诸如通过联接到外部发生器的电线供应电力。在一些情况下，外科系统1000还可包括或另选地包括内部发生器1005。内部发生器1005还可被配置成能够通过内部装置诸如通过电池电源或其它存储的电容源来供应电力。下文描述了内部发生器1005和有线发生器170的进一步描述。
在某些情况下，马达驱动外科器械100可包括作为固件、软件、硬件或它们的任意组合实现的一个或多个嵌入式应用程序。在某些情况下，例如，马达驱动外科器械100可包括各种可执行模块，例如软件、程序、数据、驱动器和/或应用程序接口(API)。在某些情况下，外科器械100还可包括一个或多个显示器或其它图形指示器1035，诸如用于指示施加到端部执行器的能量水平。
在一些方面，返回电极可能有双重目的，充当治疗和神经刺激输出两者的电回路。以这种方式，治疗能量的递送可能呈单极电外科的形式，因为单个返回电极可避免对双极能量递送的需要。此配置在任何示出用于神经刺激能量路径的返回电极的示例中，包括在图1-10中被允许。
图12示出根据本公开的一些方面的神经刺激系统1200的一个方面。神经刺激系统1200提供一种用具有多个路径的双极、超声或组合双极和超声器械刺激神经的技术。神经刺激系统1200可表示如何将低能量刺激与高能量治疗应用结合在相同的医疗装置中的一种示例，如图1-11中所述。通常，神经刺激电极组为一对紧密间隔的电极或探针电极连同返回垫或针。将组织放置在第一所述对之间并进行刺激，或者将返回垫或针放置在适当的位置中，然后用另一个电极探测目标组织。在一个方面中，神经刺激系统1200包括两个独立的电路A和B，即由同一波形驱动(优选双相源，但可以是简单直流电[DC]级别)。电路A和B两者均在垫或针中具有共同的回路，但是A和B被配置成能够彼此相差。在双极器械的情况下，A和B节点通过RF阻塞电路(低通滤波器)联接到处理电极，使得通过刺激电路或通过刺激电路的针或垫回路未返回进行治疗RF。以这种方式，组织可通过A和B电路在处理电极之间刺激，并且从A到回路或从B到回路刺激。
具体地如图12中所示，神经刺激系统1200包括RF发生器电路1202和神经刺激电路1204。RF发生器电路1202包括联接到放大器1208的RF源1206。放大器1208的输出通过隔离变压器1210联接到第一阻塞电容器1212和第二阻塞电容器1214。第一阻塞电容器1212联接到第一电极1216，并且第二阻塞电容器1214联接到第二电极1220。正如所示，待处理的组织1220位于第一电极126与第二电极1218之间。导电元件1222(诸如垫或针)联接到组织1220和神经刺激电路1204的共同回路1238。
现在转到神经刺激电路1204，如图12所示，神经刺激电路1024包括双相源1224，该双相源联接到两个单独电路，即第一刺激放大器1226和第二刺激放大器1228。正如所示，第一刺激放大器1226和第二刺激放大器1228由相同的波形驱动，优选由双相源1224生成，但它们可由例如简单的DC电源驱动。第一刺激放大器1226和第二刺激放大器1228两者均具有联接到组织1220的共同回路1238，并且可联接到垫或针。然而，第一刺激放大器1226和第二刺激放大器1228被配置成能够彼此相差。在双极器械的情况下，第一刺激放大器1226和第二刺激放大器1228的节点通过相应的RF阻塞电路(例如，低通滤波器)联接到处理电极1216,1218，其中第一阻塞电路包括第一电容器1230和第一电感器1234并且第二阻塞电路包括第二电容器1232和第二电感器1236，使得通过刺激电路1204或通过针或垫1222未返回进行处理RF，该针或垫1222联接到刺激电路1204的共同回路1238。以这种方式，组织1220可通过第一放大器电路1226和第二放大器电路1228在处理电极1216,1218之间刺激，并且从第一放大器电路1226到回路或从第二放大器电路1228到回路来刺激。因此，第一磁极和第二磁极具有单独的信号生成电路，该电路包括具有共同回路1238的第一放大器电路1226和第二放大器电路1228。刺激路径可以通过第一放大器电路1226或通过第二放大器电路1228到回路1238，以及由于共同回路1238而从第一放大器电路1226到第二放大器电路1228。
组合RF和超声器械可被配置成能够递送RF能量、超声能量，并且可刺激全部在相同器械/发生器中的神经。优点包括但不限于外科医师的简单性、器械交换的需要减小、在器械钳口内并入神经刺激功能使得可在将全部抓紧力施加到组织之前(避免损害那些神经或结构)并在施加破坏神经的能量之前评价组织的神经，该神经可处于器械抓持中或用RF和/或超声治疗能量的热效应处理。
在其它方面，治疗能量处理可包括激光、微波以及其他能量源。
在其它方面，神经刺激信号可经由装置柄部中的独立电路或使用来自发生器的特殊输出波形在发生器内生成。
另外，在其它方面，在钳口完全闭合之前，可在处理电极之间自动施加神经刺激信号，使得外科医生可观察任何刺激效应并潜在地避免不需要的神经损伤。在一个方面，可采用控制器来关闭此功能。在另一方面，指示器可位于器械上以显示神经刺激电路“开启”，例如通电、启动等，如IEC 60601-2-10所示，其示出此类刺激器械的指示器。
在其它方面，证明当组织与刺激电极或处理电极或超声刀或组织垫接触时，组织感测电路“开启”，例如通电、启动等神经刺激信号。
本公开的神经刺激功能的能量轮廓不同于治疗功能的能量轮廓。因此，本公开的方面包括描述神经刺激能量可如何在治疗能量产生的同时产生。
在一些情况下，各种方面可实现为制造制品。所述制造制品可以包括被布置为存储用于执行一个或多个方面的各种操作的逻辑、指令和/或数据的计算机可读存储介质。在各种方面中，例如，所述制品可包括磁盘、光盘、闪存存储器或固件，这些制品均含有适于由通用处理器或专用处理器执行的计算机程序指令。然而，各方面并不仅限于此。
结合本文所公开的方面描述的各种功能性元件、逻辑块、模块、和电路元件的功能可在计算机可执行指令的一般环境中实施，诸如由处理单元执行的软件、控制模块、逻辑、和/或逻辑模块。一般而言，软件、控制模块、逻辑、和/或逻辑模块包括布置成执行特定操作的任何软件元件。软件、控制模块、逻辑、和/或逻辑模块可包括执行特定任务或实施特定抽象数据类型的例程、程序、对象、部件、数据结构等。软件、控制模块、逻辑、和/或逻辑模块和技术的具体实施可存储在某种形式的计算机可读介质上并且/或者通过某种形式的计算机可读介质传递。就此而言，计算机可读介质可以是可用于存储信息且可由计算设备访问的任何可用介质。一些方面还可在分布式计算环境中实践，在所述分布式计算环境中，操作由通过通信网络链接的一个或多个远程处理设备执行。在分布式计算环境中，软件、控制模块、逻辑和/或逻辑模块可位于包括存储器存储设备在内的本地和远程计算机存储介质两者中。
此外，应当理解，本文所述的方面阐明了示例性具体实施，并且功能性元件、逻辑块、模块和电路元件可以与所述方面一致的各种其它方式来实施。此外，由此类功能性元件、逻辑块、模块、和电路元件执行的操作可组合和/或分离，以用于给定的具体实施，并且可由更多数量或更少数量的部件或模块来执行。如本领域技术人员在阅读本公开之后所显而易见的，本文所述和所示的单独方面中的每个具有分立部件和特征，在不背离本公开的范围的前提下，所述部件和特征可容易地与其它若干方面中任意方面的特征分离或组合。可按所述事件的顺序或按任何其他在逻辑上可能的顺序来执行任何所述方法。
除非另外特别说明，否则应当理解，术语诸如“处理”、“运算”、“计算”、“确定”等是指计算机或计算系统、或类似电子计算装置的动作和/或过程，该电子计算装置诸如通用处理器、DSP、ASIC、FPGA或其它可编程逻辑装置、分立门或晶体管逻辑、分立硬件部件，或它们的任何组合，其被设计以执行本文所述的功能，其操纵表示为寄存器和/或存储器内的物理量(例如，电子)的数据并且/或者将其转换成类似地表示为存储器、寄存器或其它此类信息存储装置、传送装置或显示装置内的物理量的其它数据。
值得注意的是，一些方面可使用表达“联接”和“连接”以及它们的衍生词来描述。并不希望这些术语是彼此同义的。例如，一些方面可使用术语“连接”和/或“联接”来描述，以表示两个或更多个元件彼此直接物理接触或电接触。然而，术语“联接”还可指两个或更多个元件彼此不是直接接触，而是彼此配合或相互作用。就软件元件而言，例如，术语“联接”可以是指接口、消息接口、以及应用程序接口、交换消息等。
本文所公开的装置可被设计成在单次使用后废弃，或者其可被设计成多次使用。然而无论是哪种情况，该装置都可在至少使用一次后经过修整再行使用。修整可包括拆卸装置、之后清洁或替换特定零件以及后续重新组装步骤的任意组合。具体地，所述装置可拆卸，而且可以任意组合选择性地替换或移除所述装置的任意数目的特定零件或部件。在清洁和/或替换特定部件后，可对所述装置进行重新组装，以便随后在修整设施处使用或就在外科手术之前由手术团队使用。本领域的技术人员将会理解，修整装置可利用各种技术来进行拆卸、清洁/替换和重新组装。此类技术的使用以及所得的修复装置均在本申请的范围内。
尽管本文已描述了各种方面，但可以实施并且本领域的技术人员将会想到这些方面的许多修改形式、变型形式、替换形式、改变形式和等效形式。另外，在公开了用于某些部件的材料的情况下，也可使用其它材料。因此，应当理解，上述具体实施方式和所附的权利要求旨在涵盖属于本发明所公开的方面的范围内的所有此类修改形式和变型形式。以下权利要求旨在涵盖所有此类修改形式和变型形式。

Claims (19)

1.一种外科器械，包括：
第一钳口柄部和第二钳口柄部，所述第一钳口柄部和第二钳口柄部围绕接合部枢转地联接；
所述第一钳口柄部在所述第一钳口柄部的远侧端部处包括第一钳口；
所述第二钳口柄部在所述第二钳口柄部的远侧端部处包括第二钳口；
当所述第一钳口柄部和所述第二钳口柄部围绕所述接合部枢转地旋转到闭合位置时，所述第一钳口和所述第二钳口被配置成能够抓紧两者间的组织；
电刺激探针，其物理地联接到所述第一钳口柄部或所述第二钳口柄部的近侧部分，并且与所述第一钳口和所述第二钳口物理上分开，从而所述电刺激探针的远端不接触所述第一钳口和所述第二钳口；
所述第一钳口和所述第二钳口中的至少一者被配置成能够递送更高能量水平的治疗能量，以用于密封或切割手术部位处的组织；并且
所述第一钳口和所述第二钳口中的至少一者被配置成能够递送更低能量水平的非治疗能量，以用于向所述手术部位处的神经组织提供电刺激。
2.根据权利要求1所述的外科器械，其中所述治疗能量包括超声能量。
3.根据权利要求1所述的外科器械，其中所述治疗能量包括高频率电外科能量。
4.根据权利要求1所述的外科器械，其中所述第一钳口和所述第二钳口两者均被配置成能够将所述非治疗能量递送到所述手术部位处的所述组织，并且其中在所述第一钳口和所述第二钳口两者处均递送的所述非治疗能量处于相同的电势。
5.根据权利要求1所述的外科器械，其中所述第一钳口和所述第二钳口中的至少一者在所述钳口的内部部分上包括绝缘材料，使得在所述闭合位置所述第一钳口通过接触所述绝缘材料的方式来接触所述第二钳口。
6.一种外科器械，包括：
柄部组件；以及
端部执行器，所述端部执行器以能够通信的方式联接到所述柄部组件并且包括：
第一钳口和第二钳口；和
电刺激探针，其物理地联接到所述第一钳口柄部或所述第二钳口柄部的近侧部分，并且与所述第一钳口和所述第二钳口物理上分开，从而所述电刺激探针的远端不接触所述第一钳口和所述第二钳口；
所述柄部组件被配置成能够操纵所述第一钳口和所述第二钳口，以限定打开位置和闭合位置；并且
所述端部执行器被配置成能够：
通过所述第一钳口和所述第二钳口递送更高能量水平的治疗能量，以用于密封或切割手术部位处的组织；并且
通过所述电刺激探针递送更低能量水平的非治疗能量，以用于向所述手术部位处的神经组织提供电刺激。
7.根据权利要求6所述的外科器械，其中所述端部执行器还包括狭槽，其中所述电刺激探针是可回缩的，并且还被配置成能够在朝向所述柄部组件的近侧方向上回缩并进入所述端部执行器的所述狭槽，并在远离所述柄部组件的远侧方向中伸展并从所述端部执行器的所述狭槽里出来。
8.根据权利要求6所述的外科器械，其中所述端部执行器还包括返回探针，所述返回探针联接到所述端部执行器的所述近侧部分并与所述第一钳口和所述第二钳口物理地分开定位，从而所述返回探针的远侧端部不接触所述第一钳口和所述第二钳口，其中当所述返回探针和所述电刺激探针两者均接触所述手术部位处的组织时，所述电刺激探针和所述返回探针完成电路，并且其中所述返回探针充当所述非治疗能量的电回路。
9.根据权利要求6所述的外科器械，其中所述电刺激探针的远侧端部被配置成能够基本上靠近所述端部执行器的第一侧形成轮廓，所述端部执行器的所述第一侧包括由所述第一钳口和所述第二钳口限定的所述端部执行器的远侧末端的第一部分。
10.根据权利要求9所述的外科器械，其中所述端部执行器还包括返回探针，所述返回探针联接到所述端部执行器的所述近侧部分并与所述第一钳口和所述第二钳口物理地分开定位，从而所述返回探针的远侧端部不接触所述第一钳口和所述第二钳口，所述返回探针的所述远侧端部被配置成能够基本上靠近所述端部执行器的与所述第一侧相对的第二侧并朝向所述电刺激探针的所述远侧端部形成轮廓，所述端部执行器的所述第二侧包括由所述第一钳口和所述第二钳口限定的所述端部执行器的所述远侧末端的第二部分，其中当所述返回探针和所述电刺激探针两者均接触所述手术部位处的组织时，所述电刺激探针和所述返回探针完成电路。
11.根据权利要求6所述的外科器械，其中所述端部执行器还包括第一电突起探针，所述第一电突起探针联接到所述第一钳口或所述第二钳口的远侧端部并且被配置成能够递送所述非治疗能量，以刺激所述手术部位处的所述神经组织。
12.根据权利要求11所述的外科器械，其中所述端部执行器还包括第二电突起返回探针，所述第二电突起返回探针联接到所述第一钳口或所述第二钳口的所述远侧端部并且被配置成能够当所述第一电突起探针和所述第二电突起返回探针两者均接触所述手术部位处的组织时与所述第一电突起一起完成电路。
13.根据权利要求6所述的外科器械，还包括联接到所述柄部组件的远侧端部和所述端部执行器的近侧端部的轴，所述轴被配置成能够将所述端部执行器电联接到所述柄部组件。
14.一种外科系统，包括：
柄部组件；
电力发生器，所述电力发生器电联接到所述柄部组件；以及
端部执行器，所述端部执行器以能够通信的方式联接到所述柄部组件并且电联接到所述电力发生器并包括：
第一钳口和第二钳口；和
电刺激探针，其物理地联接到所述第一钳口柄部或所述第二钳口柄部的近侧部分，并且与所述第一钳口和所述第二钳口物理上分开，从而所述电刺激探针的远端不接触所述第一钳口和所述第二钳口；
所述柄部组件被配置成能够操纵所述第一钳口和所述第二钳口，以限定打开位置和闭合位置；
所述端部执行器被配置成能够：
通过所述第一钳口和所述第二钳口选择性递送更高能量水平的治疗能量，以用于密封或切割手术部位处的组织；并且
通过所述电刺激探针选择性递送更低能量水平的非治疗能量，以用于向所述手术部位处的神经组织提供电刺激；
所述电力发生器被配置成能够：
生成将被传递到所述端部执行器的更高能量水平的所述治疗能量；并且
生成将被传递到所述端部执行器的更低能量水平的所述非治疗能量。
15.根据权利要求14所述的外科系统，其中所述端部执行器还包括狭槽，其中所述电刺激探针是可回缩的，并且还被配置成能够在朝向所述柄部组件的近侧方向上回缩并进入所述端部执行器的所述狭槽，并在远离所述柄部组件的远侧方向中伸展并从所述端部执行器的所述狭槽里出来。
16.根据权利要求14所述的外科系统，其中所述端部执行器还包括返回探针，所述返回探针联接到所述端部执行器的所述近侧部分并与所述第一钳口和所述第二钳口物理地分开定位，从而所述返回探针的远侧端部不接触所述第一钳口和所述第二钳口，其中当所述返回探针和所述电刺激探针两者均接触所述手术部位处的组织时，所述电刺激探针和所述返回探针完成电路，并且其中所述返回探针充当用于所述非治疗能量的电回路。
17.根据权利要求14所述的外科系统，其中所述电刺激探针的远侧端部被配置成能够基本上靠近所述端部执行器的第一侧形成轮廓，所述端部执行器的所述第一侧包括由所述第一钳口和所述第二钳口限定的所述端部执行器的远侧末端的第一部分。
18.根据权利要求17所述的外科系统，其中所述端部执行器还包括返回探针，所述返回探针联接到所述端部执行器的所述近侧部分并与所述第一钳口和所述第二钳口物理地分开定位，从而所述返回探针的远侧端部不接触所述第一钳口和所述第二钳口，所述返回探针的所述远侧端部被配置成能够基本上靠近所述端部执行器的与所述第一侧相对的第二侧并朝向所述电刺激探针的所述远侧端部形成轮廓，所述端部执行器的所述第二侧包括由所述第一钳口和所述第二钳口限定的所述端部执行器的所述远侧末端的第二部分，其中当所述返回探针和所述电刺激探针两者均接触所述手术部位处的组织时，所述电刺激探针和所述返回探针完成电路。
19.根据权利要求16所述的外科系统，其中所述治疗能量是单极的并且所述返回探针进一步充当所述治疗能量的电回路。
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