CN112315575A - 用于在患者上进行电外科手术介入的装置 - Google Patents

用于在患者上进行电外科手术介入的装置 Download PDF

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CN112315575A
CN112315575A CN202010691878.XA CN202010691878A CN112315575A CN 112315575 A CN112315575 A CN 112315575A CN 202010691878 A CN202010691878 A CN 202010691878A CN 112315575 A CN112315575 A CN 112315575A
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sensor
patient
signal
generator
block
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U·比贝尔
O·于尔祖特
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Erbe Elecktromedizin GmbH
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Erbe Elecktromedizin GmbH
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Abstract

本发明涉及用于在患者上进行电外科手术介入的装置。本发明的外科手术装置包括具有发电机（20）的设备（15）以及由发电机（20）提供的器械（14）。另外，传感器（27）是装置的一部分部分，该在手术期间装置附接到患者，特别是附接到其肢体，以便检测患者并且特别是肢体的运动。传感器与控制装置（23）连接，如果传感器检测到患者（11）的运动超过阈值（sa），则所述控制装置（23）修改发电机（20）的操作，并且特别地关闭发电机。因此，避免了患者（11）在外科手术过程期间由于无意识的抽动而可能发生的伤害。

Description

用于在患者上进行电外科手术介入的装置
技术领域
本发明涉及一种用于在患者上进行电外科手术介入的装置，特别是在泌尿学中。
背景技术
外科介入期间，特别是电外科手术介入期间，尽管使用射频电流，神经肌肉刺激仍能够发生。如果射频电流的频率超过100 kHz的限制，这种情况也会发生，该限制被认为是临界限制。特别地，它涉及膀胱的经尿道电切除术以及泌尿学中的前列腺的经尿道电切除术和妇科中的宫腔镜经宫颈切除术。该领域中的神经肌肉刺激能够导致闭孔神经的刺激，并随之引起突然且剧烈的腿内收肌收缩。这些收缩能够导致患者的不受控制的运动，例如，在他/她的膀胱中引入器械，有膀胱壁穿孔的危险。关于该问题存在大量的文献：
1. Ozer K, Horsonoli MO, Gorge SN et al. Bladder injury secondary toobturator reflex is more common with plasmakinetic transurethral resectionthan monopolar transurethral resection of bladder cancer（闭孔反射继发的膀胱损伤在膀胱癌的经尿道等离子切除术中比在经尿道单极切除术中更常见）. Cent EuropeanJ Urol 2015;68:284-288
2. Ferlay J, Autier P, Boniol M et al. Estimates of the cancer incidenceand mortality in Europe In 2006（2006年的欧洲癌症发病率和死亡率估计）. AnnOncol.2007;18:581-592
3. Kausch I, Doehn C, Jocham D. Recent improvements in the detection andtreatment of nonmuscleinvasive bladder cancer（非肌肉浸润性膀胱癌的检测和治疗的最新进展）. Expert Rev Anticancer Ther 2006; 6: 1301-1311
4. Desantis CE, Lin CC Mariotto AB et al. Cancer treatment andsurvivorship statistics, 2014（癌症治疗和生存统计，2014）. CA Cancer J Clin2014;64:252-271
5. Aas-Eng MK, Langebrekke A, Hudelist G. Complications in operativehysteroscopy-is prevention possible（宫腔镜手术并发症——可以预防吗）. ActaObstet Gynecol Scand 2017; 96: 1399-1403
6. Shulman Ms, Vellayappan U, Monaghan TG et al. Simultaneous bilateralobturator nerve stimulation during transurethral electrovaporization of theprostate（在前列腺的经尿道电汽化术期间的同时双侧闭孔神经刺激）. J Clin Anesth1998; 10: 518-521
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发明内容
本发明的目的是提供一种装置，利用该装置，能够在降低外科手术风险的情况下在患者上进行电外科手术介入。
这个目的是用根据权利要求1所述的装置来解决的：
本发明的外科装置特别适合用于在患者上进行电外科手术介入，例如，用于进行膀胱的经尿道电切除术、前列腺的经尿道电切除术或宫腔镜切除术（TURB、TURP、TCR）。带有用于产生治疗电压的发电机的设备形成装置的一部分，器械通过该发电机被供电。另外，用于控制发电机的控制装置是设备的一部分。发电机的控制至少包括打开和关闭发电机。另外，发电机的控制还能够包括设置外科手术模式，如解剖、切除、凝结等。不同的外科手术模式是通过调整不同的发电机电压和/或发电机处的不同电压调制来实现的。例如，电压调制能够是脉冲宽度调制、频率调制等。
配置为附接到患者并且配置为检测患者的运动的传感器也是装置的一部分。传感器与控制装置连接。在这样做时，由神经肌肉刺激所引起的肌肉收缩能够被迅速识别并且被用于实施控制信号。例如，在这样做时，如果确定患者有不期望运动，则发电机能够被关闭或能够在其操作时以其它方式被影响。例如，控制装置能够配置为至少在时间阶段期间或在确定患者的不期望运动的情况下永久减小发电机的功率和/或改变射频电压的调制和/或关闭发电机。
如果在确定患者的不期望运动的情况下迅速关闭发电机，则神经肌肉刺激能够迅速消除，并且肌肉收缩因此能够受限于无干扰的量，特别是无危险的量。因此，避免了由于肌肉收缩引起的膀胱壁穿孔或其它外科手术并发症。
优选地，传感器是位置传感器、运动传感器或加速度传感器。由配置为位置传感器的传感器所输出的信号能够被一次或多次进行时间区分（按时间区分），以便产生指示突然运动的信号。在这样做时，避免了由于患者的缓慢或轻微运动而造成的对外科手术结果无害的不期望关闭。然而，在刚开始时已经检测到突然的抽动或剧烈的运动。传感器产生相应的信号，这些信号由信号评估电路评估，并且被考虑以用于关闭发电机。
有利地，传感器包括附接装置，利用该附接装置，传感器能够附接在患者的肢体处，特别是脚或腿处，例如在他/她的小腿处。在适当的位置处环绕患者的肢体的带或者还有设置在传感器处的粘接区域适合作为附接装置，利用该带或该粘接区域，传感器能够黏接地附接在患者的皮肤处。
有利地，控制装置包括信号评估装置，该信号评估装置配置为通过信号处理装置将由传感器所提供的信号或从其获得的信号与阈值进行比较，并且配置成如果超过阈值，则产生关闭信号。
信号处理装置能够包括一个或多个滤波器（高通、低通、带通）、线性或非线性放大器等。
除了检测阈值超过之外，信号评估装置还能够配置为在达到该阈值之前输出警告信号。例如，第一阈值能够被设置成约3 m/s2的加速度，而将导致关闭（即安全关闭）的第二阈值能够是例如11 m/s2的加速度。
控制装置能够配置为在产生关闭信号之后阻止发电机，并且请求手动释放。替代地，它能够配置为在例如3秒的定义持续时间内产生关闭信号。在该持续时间内，操作者能够决定他/她想要如何进行。
还可以提供具有调整装置的控制装置，利用该调整装置，能够调整关闭的持续时间。控制装置还可以设置有用于调整第一阈值和/或第二阈值的输入装置。另外，控制装置能够包括控制器，该控制器用于使控制装置的监控来自传感器的信号的部分停用。
优选地，关闭信号的输出是在没有延迟的情况下进行的，因此优选地在小于提供有传感器的肢体的可检测的肌肉运动活动开始后30 ms内，优选地在小于20 ms内。在这段短暂的持续时间内，由于肌肉收缩而发起的肢体的运动仍然非常小，使得外科医生的手动活动基本上不受干扰，在困难的外科手术的情况下也是如此。
本发明的装置能够用于双极器械以及用于单极器械，该双极器械包括两个电极，该单极器械没有计数器或中性电极本身，并且对于该单极器械，中性电极必须附接在患者上。
可以将用于检测运动（特别是患者的肢体的加速度）的传感器附接在中性电极处或中性电极中，该中性电极例如将被布置在患者的小腿处。
本发明能够用根据本发明的设备以及利用其内部控制装置未被配置成用于评估传感器信号的设备来实现。在这种设备中，控制装置的区段形成部分能够布置在设备的外部。与传感器连接的这种区段能够例如在启用开关（例如脚踏开关）中，或在单独的外壳中，该外壳连接在来自器械的启用导体或脚踏开关与设备的启用输入端之间。
附图说明
本发明的有利实施例的另外的细节受权利要求以及附图和相应的描述约束。附图示出了：
图1以示意性图示示出了处于在患者上的应用中的本发明装置，
图2以示意性局部视图示出了应用于患者的器械，
图3以示意性框图示出了用于提供器械的设备，
图4作为框图示出了根据图3的设备的信号评估电路，
图5以示意性方式示出了信号处理装置，
图6示出了用于治疗根据图1的患者的修改器械，
图7以侧视图示出了用于附接在根据图1的患者上的传感器，
图8以示意性俯视图示出了具有传感器的中性电极，
图9以图释的形式示出了信号评估装置的功能，以及
图10以截面图示示出了装置的修改实施例。
具体实施方式
图1图示了外科手术情况，其中，患者11被支撑在台12上，以进行将要进行的外科介入，例如在患者的体腔13中，例如在泌尿生殖道中。为此，将器械14插入与供电设备15连接的患者11中。器械14例如是探针16，该探针具有刚性轴或柔性轴17以及在其端部处的电极18。它能够是如所图示的单极器械。在这种情况下，中性电极19附接到患者11，该中性电极能够例如由电流转向导电胶粘膏（adhesive plaster）形成。
设备15包括发电机20，该发电机适合用于输出用于进行外科介入的适合的射频电压。它通常在高于100 V的范围内，优选地高于200 V，且频率超过100 kHz，优选地显著超过100 kHz。射频电压能够是未调制的，也能够是调制的，例如是脉冲宽度调制的。器械14的电极18经由电导体L与发电机20的输出端连接，如图1中所图示。中性电极19经由导体N与发电机15的另一输出端连接。
如图3中所图示，发电机20能够由射频功率振荡器组成，该射频功率振荡器的开关元件21激励振荡电路22，用于器械14的供电电压以变压或另一种方式从该振荡电路耦合出来。例如作用于开关元件21上以便永久地或以类似脉冲的方式激励振荡电路22的控制装置23用于控制发电机20。用于为控制装置23和发电机20供电的电力供应或另一个电源P是设备15的一部分。
控制装置23至少配置为启用和停用发电机20。在启用阶段中，开关元件21连续打开和闭合，而在停用期间保持打开（不导电）。
控制装置23包括启用块24，该启用块具有与启用开关25连接的启用输入I。这种启用开关25能够优选地手动致动，并且能够例如，配置为脚踏开关或在器械14处的开关。启用块24还包括与停用块26连接的禁止输入端0。停用块26包括输入端E，传感器27连接到该输入端E。
传感器27能够配置为位置传感器或优选地特别是配置为加速度传感器。传感器27适合于将其运动转换为电信号。特别地，传感器27适合于输出与运动速度或加速度对应的信号。
在图4中单独图示了停用块26。它能够例如包括比较器28，该比较器将来自传感器27的信号与能够例如由阈值提供器29提供的阈值sa进行比较。在比较器28的输出端处提供的信号以从传感器27输出的信号大于阈值sa的情况为特征。例如，比较器28的输出信号能够被供应给块30，以用于进一步的处理。该块30能够按照期望实现附加功能。这些功能能够是：在预定义持续时间或可调整持续时间内产生禁止信号、永久地产生关闭信号直到复位等。例如，复位信号能够由启用开关25或单独的复位开关提供。
作为一种选择，信号处理装置（例如，形式为数字信号处理器DSP）能够布置在传感器27与停用块的输入端E之间。它能够被编程以对从传感器27输出的信号进行滤波或处理。这种信号处理能够包括滤波器块、放大器块、模式识别块等。滤波器块能够是低通、高通或带通。放大器块能够是线性或非线性放大器块。
到目前为止，所描述的装置操作如下：
假设，图1中未图示的外科医生已经如所图示地将器械14插入患者11中，并且通过启用开关25启用器械14。首先，停用块26是不起作用的，使得控制装置23允许发电机20的操作。发电机20将射频电压输出到器械14，特别是在其电极18处，患者11的组织通过该电极受到影响。中性电极19接收流入患者中的电流，并且将其引导回到发电机20。
如果源自电极18的电流进入能够导致患者11的明显运动的神经路径中，特别是在闭孔神经附近，则突然的腿内收肌收缩能够发生。在这种运动开始时，传感器27立即检测运动，特别是运动的速度或加速度。如果从传感器27输出的信号超过由阈值提供器29定义的阈值sa，则生成关闭信号。
如果它例如被配置为单触发器（mono-flop），则处理块30然后能够在固定或预定义的持续时间内（例如在3 s内）产生关闭信号，该关闭信号被供应给启用块24的输入端0。因此，启用块24关闭发电机20的启用。发电机20关闭，并且在由处理块30所定义的禁止时间段期间不再输出电压。在这样做时，进一步的神经刺激被有效地禁止，因此更强烈的腿部运动被有效率地禁止。更确切地说，治疗过程在这个时间点处至少很快地被中断，然而，避免了由于患者11的突然的腿部运动而造成伤害的重大风险。在这样做时，同时也有效地避免了否则可能发生的外科手术并发症。
到目前为止，对所描述的本发明的许多修改都是可能的。在上面或下面描述的所有实施例中都是可能的第一补充是使用多个传感器27，这些传感器能够附接到肢体的不同位置或不同的肢体，特别是患者11的两条腿。在这种情况下，两个或两个以上的传感器的信号能够相加并且提供给比较器28的输入端E。同样，能够为每一个传感器提供具有单独输入端的单独比较器，其中，这些比较器的输出信号能够被逻辑地组合，使得如果比较器中的至少一个提供了关闭信号（OR连接），则发生关闭。
还可以将停用块26布置在设备15的外部。在这种情况下，设备15的外部的停用块26仍然被认为是设备15的控制装置的一部分，并且例如，布置在启用开关25中。停用块26在这种情况下能够根据上述实施例中的任何一个进行配置，并且能够配置为用于监控一个或多个传感器。在停用的情况下，它能够例如中断或短路由启用开关24提供给控制装置23的输入端I的信号。
停用块也能够布置在器械14中，特别是如果启用开关25布置在器械处。在这样做时，如果传感器27经由无线连接与停用块连接，则是有利的。
在另外的修改实施例中，停用块能够连接到发电机20的发电机输出端，例如，以便在停用事件的情况下短路在那里提供的电压。替代地，停用块26能够集成到器械14中。
在图7中单独地、示意性地图示了中心27。它能够配置为无线传感器，并且能够以无线的方式将由自己所产生的信号（例如，以运动速度或加速度为特征的信号）发送到停用块26。替代地，传感器27能够设置有电缆31，该电缆将连接在停用块26的连接部E处。
传感器27能够设置有用于附接在患者上的粘接区域32，该粘接区域32涂覆有胶水或粘合剂，以便允许附接在患者的皮肤上。替代地，附接带能够附接到传感器27，通过该附接带，传感器能够被绑到患者。
还可以不时地或连续地由监控传感器27所提供的信号的有效性，例如，以便及时识别当前没有正确地附接在患者上或已经从患者脱落的传感器27。为此，所描述的实施例中的每一个能够用监控块来补充，该监控块与从传感器输出的信号连接。监控块能够配置为仅在由传感器27所提供的信号超过传感器27的背景噪声并且因此指示患者11的无所不在的微运动的情况下，将该信号分类为有效信号。如果不再接收到这种信号，则停用块26可以发信号表明传感器信号的无效。能够规定，在这种情况下，监控块停止（禁止）发电机20。
还可以将传感器27附接在中性电极19处，如图8示意性地图示的。这些解决方案特别适合用于根据图2的单极器械。
然而，也可以使用双极器械14’，如图6中示意性地图示的。同样，电极18，并且附加地中性电极19’被附接到该器械14’。在这种情况下，导体L和N两者从器械14通向发电机20。除此之外，上述描述根据没有具体提及图8的中性电极19的所有实施例相应地应用。
本发明的另外的修改是传感器信号的精细监控，例如，其中它不仅与用于停用的阈值sa进行比较，而且附加地与较低的阈值sw进行比较，以便能够警告外科医生神经肌肉反应的存在。为此，图9图示了相应停用块的功能。它配置为首先将信号S与关闭阈值sa进行比较，并且如果达到阈值sa，则输出关闭信号。然而，如果没有达到阈值sa，则将信号S与较低的阈值sw进行比较。如果达不到阈值sw，则不采取任何动作。然而，如果信号S超过阈值sw，则输出警告信号。这种信号可以是声信号、光信号或触觉信号，例如手柄的振动。刚才描述的至少两个阈值的监控能够在上述本发明装置的所有实施例中采用。
在所有描述的实施例中，还可以仅进行发电机20的功率减小或调制类型的修改，而不是发电机20的关闭。然而，本发明的所有实施例的共同之处都在于，提供了至少一个传感器27，该传感器检测患者（优选地是其肢体）的肌肉运动刺激，并且基于这种检测到的运动，影响发电机20的操作，并且因此影响器械14的电极18处的电压。这种影响特别地具有减轻或消除神经肌肉刺激的任务，该神经肌肉刺激是患者的运动的基础。
本发明外科手术装置包括带有发电机20的设备15以及由发电机20供应的器械14。另外，传感器27是在手术期间附接到患者并且特别是其肢体以便检测患者并且特别是肢体的运动的装置的一部分。传感器与控制装置23连接，如果传感器检测到患者11的运动超过阈值sa，则该控制装置修改发电机20的操作并且特别地关闭发电机。
因此，避免了患者在外科手术过程期间由于无意识的抽动而可能发生的伤害。
附图标记列表：
11 患者
12 台
13 中空器官
14、14’ 器械
15 设备
16 探针
17 轴
18 电极
19、19’ 中性电极
20 发电机
L 导体
N 导体
21 开关元件
22 振荡电路
23 控制装置
24 启用块
I 启用输入端
25 启用开关
0 禁止输入端
26 停用块/信号评估装置
E 输入端
S 传感器信号
27 传感器
28 比较器
sa 第一阈值（用于关闭）
sw 第二阈值（用于输出警告）
29 阈值提供器
30 处理块
31 电缆
32 附接装置（粘接区域）
33 信号评估装置的区段。

Claims (15)

1.一种用于在患者上进行电外科手术介入的外科手术装置，
具有设备（15），所述设备（15）包括用于产生治疗电压的发电机（20）和用于控制所述发电机（20）的控制装置（23），
具有器械（14），所述器械包括至少一个电极（18）并且连接到发电机（20），
具有传感器（27），所述传感器配置为用于附接在所述患者（11）上并且用于检测所述患者的运动并且与所述控制装置（23）连接。
2.根据权利要求1所述的装置，其特征在于，所述控制装置（23）包括信号评估装置（26），所述信号评估装置（26）配置为以由传感器（27）所控制的方式关闭所述发电机（20）。
3.根据前述权利要求中任一项所述的装置，其特征在于，所述传感器（27）是运动传感器。
4.根据前述权利要求中任一项所述的装置，其特征在于，所述传感器（27）是加速度传感器。
5.根据前述权利要求中任一项所述的装置，其特征在于，所述传感器（27）包括附接装置（32），借助于所述附接装置（32），所述传感器（27）能够附接到所述患者（11）的肢体，特别是脚或腿。
6.根据权利要求5所述的装置，其特征在于，所述附接装置（32）是粘接区域或附接带。
7.根据前述权利要求中任一项所述的装置，其特征在于，所述控制装置（23）包括信号评估装置（26），所述信号评估装置（26）配置为将由传感器（27）所提供的信号与阈值（sa）比较，并且如果超过阈值（sa），则产生关闭信号。
8.根据权利要求7所述的装置，其特征在于，所述信号评估装置（26）配置为在定义的持续时间内产生所述关闭信号。
9.根据权利要求8所述的装置，其特征在于，所述持续时间是可调整的。
10.根据前述权利要求中任一项所述的装置，其特征在于，所述信号评估装置（26）配置为相对于至少两个阈值（sa、sw）监控信号（S），以便在超过第一阈值（sw）时产生警告信号，并且在超过第二阈值（sa）时产生关闭信号。
11.根据前述权利要求中任一项所述的装置，其特征在于，所述发电机（20）与设置在所述器械（14）处的中性电极（19）连接。
12.根据前述权利要求中任一项所述的装置，其特征在于，所述发电机（20）与能够附接到所述患者（11）的中性电极（19）连接。
13.根据权利要求12所述的装置，其特征在于，所述中性电极（19）包括所述传感器（27）。
14.根据前述权利要求中任一项所述的装置，其特征在于，所述控制装置（23）包括布置在所述设备（15）的外部的至少一个区段（33）。
15.根据权利要求2、7、8、9或10中任一项所述的装置，其特征在于，布置在所述设备的外部的所述区段（33）包括所述信号评估装置（26）。
CN202010691878.XA 2019-07-18 2020-07-17 用于在患者上进行电外科手术介入的装置 Pending CN112315575A (zh)

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