技术领域Technical Field
本发明涉及医学器械技术领域，尤其涉及一种自动冲洗气泡的灌注装置。The invention relates to the technical field of medical instruments, and in particular to an automatic bubble flushing perfusion device.
背景技术Background technique
临床上心律失常介入手术通用消融模式包括RFA(RadioFrequency Ablation)射频消融，冷冻消融，以及PFA(Pulsed Field Ablation)脉冲电场消融。在RFA和PFA消融手术治疗过程中，灌注泵通常是一个重要组成部分，通过兼容的灌注管路系统从连接的灌注溶液袋向兼容的灌注导管输送灌注溶液，经过导管内腔的通道将灌注溶液输送至导管消融头端，灌注生理盐水以降低消融电极和周围心肌组织的温度，以防止靶点组织结痂或粘连，还能增加消融毁损组织的深度和面积；同时在高电压脉冲电场消融场景下冲洗微气泡，是非常重要的临床器械。Common ablation modes for interventional arrhythmia surgery in clinical practice include RFA (Radio Frequency Ablation), cryoablation, and PFA (Pulsed Field Ablation). In the RFA and PFA ablation procedures, the perfusion pump is usually an important component, which delivers perfusion solution from the connected perfusion solution bag to the compatible perfusion catheter through a compatible perfusion pipeline system, and delivers the perfusion solution to the catheter ablation tip through the channel in the catheter lumen. Physiological saline is perfused to reduce the temperature of the ablation electrode and surrounding myocardial tissue to prevent scab or adhesion of the target tissue, and also to increase the depth and area of the ablated damaged tissue; at the same time, it flushes microbubbles in high-voltage pulsed electric field ablation scenarios, and is a very important clinical device.
在现有灌注系统中，当灌注管路中出现气泡时，气泡进入人体就会对病人产生不利的影响，当气泡体积大于5ml时甚至会制人死亡。临床中，当气泡检测到体积大于0.4毫升时，需要停止消融手术，手动关闭导管盐水，然后手动启动冲洗导管盐水灌注道路，直到管路中没有气泡为止，再重新打开导管盐水，重新开始消融手术，因此，手术过程中会因为需要排除气泡而中断消融过程，手动切换至冲洗管路进行排气泡处理，从而影响消融手术效率。In the existing perfusion system, when bubbles appear in the perfusion pipeline, the bubbles will enter the human body and have an adverse effect on the patient. When the volume of the bubbles is greater than 5 ml, it may even cause death. In clinical practice, when the volume of bubbles detected is greater than 0.4 ml, the ablation surgery needs to be stopped, the catheter saline is manually closed, and then the catheter saline perfusion road is manually started to flush until there are no bubbles in the pipeline. The catheter saline is then reopened and the ablation surgery is restarted. Therefore, the ablation process will be interrupted during the operation because of the need to remove bubbles, and the flushing pipeline is manually switched to remove bubbles, which affects the efficiency of the ablation surgery.
发明内容Summary of the invention
本发明要解决的技术问题是，如何自动、快速地消除灌注溶液中的气泡；有鉴于此，本发明提供一种自动冲洗气泡的灌注装置。The technical problem to be solved by the present invention is how to automatically and quickly eliminate bubbles in a perfusion solution; in view of this, the present invention provides a perfusion device for automatically flushing bubbles.
本发明采用的技术方案是，一种自动冲洗气泡的灌注装置，包括：The technical solution adopted by the present invention is a perfusion device for automatically flushing bubbles, comprising:
灌注管路以及灌注泵；Infusion pipeline and infusion pump;
所述灌注管路包括输入接口、二连二通阀门以及分别与所述二连二通阀门的输出端连接的气泡冲洗出口和导管盐水灌注口；The perfusion pipeline includes an input interface, a two-way two-way valve, and a bubble flushing outlet and a catheter saline perfusion port respectively connected to the output ends of the two-way two-way valve;
所述灌注泵包括核心系统控制模块，与所述核心系统控制模块连接的气泡检测模块以及蠕动泵；The perfusion pump includes a core system control module, a bubble detection module connected to the core system control module, and a peristaltic pump;
其中，所述气泡检测模块用于检测所述二连二通阀门输入端前管路中的灌注溶液中是否存在气泡；Wherein, the bubble detection module is used to detect whether there are bubbles in the perfusion solution in the pipeline before the input end of the two-way two-way valve;
当存在气泡时，通过所述核心系统控制模块控制所述二连二通阀门的输出端切换至所述气泡冲洗出口，并且控制所述蠕动泵提升所述灌注管路输入接口一端的液体流速，用于排出当前灌注溶液；When bubbles exist, the core system control module controls the output end of the two-way two-way valve to switch to the bubble flushing outlet, and controls the peristaltic pump to increase the liquid flow rate at one end of the perfusion pipeline input interface to discharge the current perfusion solution;
当不存在气泡时，通过所述核心系统控制模块控制所述二连二通阀门的输出端切换至所述导管盐水灌注口，以使得灌注溶液用于后续灌注处理。When there are no bubbles, the core system control module controls the output end of the two-way two-way valve to switch to the catheter saline perfusion port, so that the perfusion solution is used for subsequent perfusion treatment.
在一个实施方式中，所述装置还包括：交互模块；In one embodiment, the device further comprises: an interaction module;
所述交互模块与所述核心系统控制模块连接，用于响应术者通过所述交互模块的交互操作，所述核心系统控制模块生成对应的控制指令，以使得所述蠕动泵调节所述灌注管路输入接口一端的液体流速。The interactive module is connected to the core system control module and is used to respond to the operator's interactive operation through the interactive module. The core system control module generates corresponding control instructions to enable the peristaltic pump to adjust the liquid flow rate at one end of the perfusion pipeline input interface.
在一个实施方式中，所述装置还包括：报警模块；In one embodiment, the device further comprises: an alarm module;
所述报警模块用于在灌注管路中监测到气泡出现时，对术者进行警示。The alarm module is used to warn the operator when bubbles are detected in the perfusion pipeline.
在一个实施方式中，所述装置还包括：通讯模块；In one embodiment, the device further comprises: a communication module;
所述通讯模块外接消融仪，用于根据导管消融工作状态配置不同的灌注流速参数。The communication module is externally connected to an ablation device and is used to configure different perfusion flow rate parameters according to the working state of the catheter ablation.
在一个实施方式中，所述灌注管路的输入接口为溶液袋插头，与输液袋相连，管路的主体为耐挤压软管。In one embodiment, the input interface of the perfusion pipeline is a solution bag plug connected to the infusion bag, and the main body of the pipeline is a squeeze-resistant hose.
在一个实施方式中，所述气泡监测模块包括超声波传感器以及比较器；In one embodiment, the bubble monitoring module includes an ultrasonic sensor and a comparator;
所述超声波传感器用于实时监测所述灌注管路中的气泡，所述超声波传感器包括相对设置于灌注管路两侧的超声发生装置和超声接收装置，发生装置发射超声波穿过灌注管路及灌注管路内的生理盐水回到超声波接收装置，并由比较器对接收到的超声波信号进行比对，并基于比对的结果，确定当前所述灌注管路中气泡的体积，当体积大于预设值时，判定灌注管路内存在气泡。The ultrasonic sensor is used to monitor the bubbles in the perfusion pipeline in real time. The ultrasonic sensor includes an ultrasonic generator and an ultrasonic receiver which are relatively arranged on both sides of the perfusion pipeline. The generator transmits ultrasonic waves through the perfusion pipeline and the physiological saline in the perfusion pipeline and returns to the ultrasonic receiver. The comparator compares the received ultrasonic signals and determines the volume of the bubbles in the perfusion pipeline based on the comparison result. When the volume is greater than a preset value, it is determined that there are bubbles in the perfusion pipeline.
在一个实施方式中，所述灌注管路外接的输液袋为多级串联构成。In one embodiment, the infusion bag externally connected to the perfusion pipeline is constructed in multiple stages in series.
在一个实施方式中，所述蠕动泵的流速控制包括如下三种模式：In one embodiment, the flow rate control of the peristaltic pump includes the following three modes:
低流速模式，流速范围设置为：2ml/min到5ml/min；Low flow rate mode, the flow rate range is set to: 2ml/min to 5ml/min;
高流速模式，流速范围设置为：6ml/min到60ml/min；High flow rate mode, the flow rate range is set to: 6ml/min to 60ml/min;
冲洗模式，流速设置为：100ml/min。In flushing mode, the flow rate is set to: 100 ml/min.
在一个实施方式中，所述通讯模块进一步用于获取外接消融仪的工作状态，在射频热消融时切换到所述高流速模式，在停止消融或脉冲电场消融下切换至所述低流速模式。In one embodiment, the communication module is further used to obtain the working status of an external ablation device, switch to the high flow rate mode during radiofrequency thermal ablation, and switch to the low flow rate mode when ablation is stopped or pulsed electric field ablation is performed.
本发明的另一方面还提供了一种手术机器人，所述手术机器人包括如上任一项所述的自动冲洗气泡的灌注装置，用于响应于术者操作以完成消融手术处理。Another aspect of the present invention provides a surgical robot, comprising an automatic bubble flushing irrigation device as described in any one of the above items, for responding to an operator's operation to complete an ablation surgical treatment.
采用上述技术方案，本发明至少具有下列优点：By adopting the above technical solution, the present invention has at least the following advantages:
本发明提供的自动冲洗气泡的灌注装置可实现自动监测管路中气泡生成情况，当监测到的气泡体积超过设定数值后可实现自动报警同时完成气泡冲洗操作，简化手术过程，提高手术安全性和手术效率。The automatic bubble flushing perfusion device provided by the present invention can automatically monitor the bubble generation in the pipeline. When the monitored bubble volume exceeds a set value, an automatic alarm can be issued and the bubble flushing operation can be completed at the same time, thereby simplifying the surgical process and improving surgical safety and efficiency.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1为根据本发明实施例的自动冲洗气泡的灌注装置的组成示意图；FIG1 is a schematic diagram of a composition of an automatic bubble flushing perfusion device according to an embodiment of the present invention;
图2为根据本发明应用实例的自动冲洗气泡的灌注过程的原理示意图；FIG2 is a schematic diagram showing the principle of the automatic flushing bubble perfusion process according to an application example of the present invention;
图3为根据本发明应用实例的自动冲洗气泡的灌注装置的组成架构示意图；FIG3 is a schematic diagram of the composition structure of an automatic flushing bubble perfusion device according to an application example of the present invention;
图3为根据本发明应用实例的自动冲洗气泡的灌注装置组成结构图；FIG3 is a structural diagram of an automatic flushing bubble filling device according to an application example of the present invention;
图4为根据本发明应用实例的灌注管路装置结构示意图；FIG4 is a schematic diagram of the structure of a perfusion pipeline device according to an application example of the present invention;
图5为根据本发明应用实例的盐水管路安装的结构示意图；FIG5 is a schematic structural diagram of a brine pipeline installation according to an application example of the present invention;
图6为根据本发明应用实例的灌注流量泵整体结构示意图；6 is a schematic diagram of the overall structure of a perfusion flow pump according to an application example of the present invention;
图7为根据本发明应用实例的灌注管路内监测到气泡时的灌注泵反馈装置示意图；7 is a schematic diagram of a perfusion pump feedback device when bubbles are detected in the perfusion pipeline according to an application example of the present invention;
图8为根据本发明应用实例的盐水冲洗模式下灌注泵反馈装置示意图。FIG8 is a schematic diagram of an infusion pump feedback device in a saline flushing mode according to an application example of the present invention.
附图标记Reference numerals
灌注泵100；Irrigation pump 100;
核心系统控制模块101，气泡检测模块102，蠕动泵103，交互模块104，报警模块105，通讯模块106；Core system control module 101, bubble detection module 102, peristaltic pump 103, interaction module 104, alarm module 105, communication module 106;
灌注管路200；Perfusion line 200;
输入接口201，二连二通阀门202，气泡冲洗出口203，导管盐水灌注口204。Input interface 201, two-way two-way valve 202, bubble flushing outlet 203, catheter saline infusion port 204.
具体实施方式Detailed ways
为更进一步阐述本发明为达成预定目的所采取的技术手段及功效，以下结合附图及较佳实施例，对本发明进行详细说明如后。In order to further explain the technical means and effects adopted by the present invention to achieve the predetermined purpose, the present invention is described in detail below in conjunction with the accompanying drawings and preferred embodiments.
在附图中，为了便于说明，已稍微夸大了物体的厚度、尺寸和形状。附图仅为示例而并非严格按比例绘制。In the drawings, the thickness, size and shape of objects have been slightly exaggerated for ease of explanation. The drawings are only examples and are not drawn strictly to scale.
还应理解的是，用语“包括”、“包括有”、“具有”、“包含”和/或“包含有”，当在本说明书中使用时表示存在所陈述的特征、整体、步骤、操作、元件和/或部件，但不排除存在或附加有一个或多个其它特征、整体、步骤、操作、元件、部件和/或它们的组合。此外，当诸如“...中的至少一个”的表述出现在所列特征的列表之后时，修饰整个所列特征，而不是修饰列表中的单独元件。此外，当描述本申请的实施方式时，使用“可以”表示“本申请的一个或多个实施方式”。并且，用语“示例性的”旨在指代示例或举例说明。It should also be understood that the terms "comprises", "including", "having", "includes" and/or "comprising", when used in this specification, indicate the presence of the stated features, wholes, steps, operations, elements and/or parts, but do not exclude the presence or addition of one or more other features, wholes, steps, operations, elements, parts and/or combinations thereof. In addition, when expressions such as "at least one of..." appear after a list of listed features, they modify the entire listed features rather than modifying the individual elements in the list. In addition, when describing embodiments of the present application, "may" is used to mean "one or more embodiments of the present application". And, the term "exemplary" is intended to refer to an example or illustration.
如在本文中使用的，用语“基本上”、“大约”以及类似的用语用作表近似的用语，而不用作表程度的用语，并且旨在说明将由本领域普通技术人员认识到的、测量值或计算值中的固有偏差。As used herein, the terms "substantially," "approximately," and similar terms are used as terms of approximation, not degree, and are intended to account for the inherent variations in measurements or calculations that would be recognized by one of ordinary skill in the art.
除非另外限定，否则本文中使用的所有用语(包括技术用语和科学用语)均具有与本申请所属领域普通技术人员的通常理解相同的含义。还应理解的是，用语(例如在常用词典中定义的用语)应被解释为具有与它们在相关技术的上下文中的含义一致的含义，并且将不被以理想化或过度正式意义解释，除非本文中明确如此限定。Unless otherwise defined, all terms (including technical terms and scientific terms) used in this article have the same meaning as commonly understood by ordinary technicians in the field to which this application belongs. It should also be understood that terms (such as terms defined in commonly used dictionaries) should be interpreted as having the same meaning as their meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined in this article.
需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将参考附图并结合实施例来详细说明本申请。It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.
本发明第一实施例，一种自动冲洗气泡的灌注装置，如图1所示，包括：The first embodiment of the present invention is an automatic bubble flushing filling device, as shown in FIG1 , comprising:
本发明采用的技术方案是，一种自动冲洗气泡的灌注装置，包括：The technical solution adopted by the present invention is a perfusion device for automatically flushing bubbles, comprising:
灌注泵100以及灌注管路200；A perfusion pump 100 and a perfusion pipeline 200;
其中，灌注管路200包括输入接口201、二连二通阀门202以及分别与二连二通阀门202的输出端连接的气泡冲洗出口203和导管盐水灌注口204；The perfusion pipeline 200 includes an input interface 201, a two-way valve 202, and a bubble flushing outlet 203 and a catheter saline perfusion port 204 respectively connected to the output ends of the two-way valve 202;
灌注泵100包括核心系统控制模块101，与核心系统控制模块101连接的气泡检测模块102以及蠕动泵103；The perfusion pump 100 includes a core system control module 101, a bubble detection module 102 connected to the core system control module 101, and a peristaltic pump 103;
并且，气泡检测模块102用于检测二连二通阀门202输入端前管路中的灌注溶液中是否存在气泡；Furthermore, the bubble detection module 102 is used to detect whether there are bubbles in the perfusion solution in the pipeline before the input end of the two-way two-way valve 202;
当存在气泡时，通过核心系统控制模块101控制二连二通阀门202的输出端切换至气泡冲洗出口203，并且控制蠕动泵103提升灌注管路输入接口201一端的液体流速，用于排出当前灌注溶液；When bubbles exist, the core system control module 101 controls the output end of the two-way two-way valve 202 to switch to the bubble flushing outlet 203, and controls the peristaltic pump 103 to increase the liquid flow rate at one end of the perfusion pipeline input interface 201 to discharge the current perfusion solution;
当不存在气泡时，通过核心系统控制模块101控制二连二通阀门202的输出端切换至导管盐水灌注口204，以使得灌注溶液用于后续灌注处理。When there are no bubbles, the core system control module 101 controls the output end of the two-way two-way valve 202 to switch to the catheter saline infusion port 204, so that the infusion solution is used for subsequent infusion treatment.
在一个实施方式中，所述装置还包括：交互模块104；In one embodiment, the apparatus further includes: an interaction module 104;
交互模块104与核心系统控制模块101连接，用于响应术者通过交互模块104的交互操作，核心系统控制模块101生成对应的控制指令，以使得蠕动泵103调节灌注管路输入接口201一端的液体流速。The interaction module 104 is connected to the core system control module 101 and is used to respond to the operator's interaction operation through the interaction module 104 . The core system control module 101 generates corresponding control instructions to enable the peristaltic pump 103 to adjust the liquid flow rate at one end of the perfusion pipeline input interface 201 .
在一个实施方式中，所述装置还包括：报警模块105；In one embodiment, the device further comprises: an alarm module 105;
报警模块105用于在灌注管路200中监测到气泡出现时，对术者进行警示。The alarm module 105 is used to warn the operator when bubbles are detected in the perfusion pipeline 200 .
在一个实施方式中，所述装置还包括：通讯模块106；In one embodiment, the device further comprises: a communication module 106;
通讯模块106外接消融仪，用于根据导管消融工作状态配置不同的灌注流速参数。The communication module 106 is externally connected to the ablation apparatus and is used to configure different irrigation flow rate parameters according to the working state of the catheter ablation.
在一个实施方式中，灌注管路200的输入接口201为溶液袋插头，与输液袋相连，管路的主体为耐挤压软管。In one embodiment, the input interface 201 of the perfusion pipeline 200 is a solution bag plug connected to the infusion bag, and the main body of the pipeline is a squeeze-resistant hose.
在一个实施方式中，气泡监测模块102包括超声波传感器以及比较器；In one embodiment, the bubble monitoring module 102 includes an ultrasonic sensor and a comparator;
超声波传感器用于实时监测所述灌注管路200中的气泡，超声波传感器包括相对设置于灌注管路两侧的超声发生装置和超声接收装置，发生装置发射超声波穿过灌注管路及灌注管路内的生理盐水回到超声波接收装置，并由比较器对接收到的超声波信号进行比对，并基于比对的结果，确定当前所述灌注管路中气泡的体积，当体积大于预设值时，判定灌注管路内存在气泡。The ultrasonic sensor is used to monitor the bubbles in the perfusion pipeline 200 in real time. The ultrasonic sensor includes an ultrasonic generator and an ultrasonic receiver which are relatively arranged on both sides of the perfusion pipeline. The generator transmits ultrasonic waves through the perfusion pipeline and the physiological saline in the perfusion pipeline and returns to the ultrasonic receiver. The comparator compares the received ultrasonic signals and determines the volume of the bubbles in the perfusion pipeline based on the comparison result. When the volume is greater than a preset value, it is determined that there are bubbles in the perfusion pipeline.
在一个实施方式中，灌注管路200外接的输液袋为多级串联构成。In one embodiment, the infusion bag externally connected to the perfusion pipeline 200 is constructed in multiple stages in series.
在一个实施方式中，蠕动泵103的流速控制包括如下三种模式：In one embodiment, the flow rate control of the peristaltic pump 103 includes the following three modes:
低流速模式，流速范围设置为：2ml/min到5ml/min；Low flow rate mode, the flow rate range is set to: 2ml/min to 5ml/min;
高流速模式，流速范围设置为：6ml/min到60ml/min；High flow rate mode, the flow rate range is set to: 6ml/min to 60ml/min;
冲洗模式，流速设置为：100ml/min。In flushing mode, the flow rate is set to: 100 ml/min.
在一个实施方式中，通讯模块106进一步用于获取外接消融仪的工作状态，在射频热消融时切换到所述高流速模式，在停止消融或脉冲电场消融下切换至所述低流速模式。In one embodiment, the communication module 106 is further used to obtain the working status of the external ablation device, switch to the high flow rate mode during radiofrequency thermal ablation, and switch to the low flow rate mode when ablation is stopped or pulsed electric field ablation is performed.
相较于现有技术，本实施例至少具有以下优点：Compared with the prior art, this embodiment has at least the following advantages:
1)本实施例可用于实现自动监测管路中气泡生成情况，当监测到的气泡体积超过设定数值后可实现自动报警同时完成气泡冲洗操作，简化手术过程，提高手术安全性和手术效率；1) This embodiment can be used to automatically monitor the bubble generation in the pipeline. When the monitored bubble volume exceeds the set value, an automatic alarm can be triggered and the bubble flushing operation can be completed at the same time, thereby simplifying the surgical process and improving surgical safety and efficiency.
2)当术者通过手术机器人远程操控消融手术的过程中，术者不需要手动进行气泡冲洗操作，当灌注管路内出现气泡时，灌注泵会自动触发报警，术者只需要停止输出消融能量，灌注泵自动就会实现气泡的快速冲洗操作，待警报解除后术者即可继续进行消融，从而简化术者操作。2) When the surgeon remotely controls the ablation surgery through the surgical robot, the surgeon does not need to manually perform bubble flushing operations. When bubbles appear in the irrigation pipeline, the irrigation pump will automatically trigger an alarm. The surgeon only needs to stop outputting ablation energy, and the irrigation pump will automatically perform a rapid flushing operation of the bubbles. After the alarm is lifted, the surgeon can continue ablation, thereby simplifying the surgeon's operation.
本发明第二实施例，如图2至图8所示，本实施例介绍了基于第一实施例所提供的一种应用实例：The second embodiment of the present invention, as shown in FIG. 2 to FIG. 8 , introduces an application example based on the first embodiment:
如图2所示为自动冲洗气泡的灌注过程的原理示意图，灌注溶液由输液袋进入气泡监测和冲洗系统，若未在灌注溶液中检测到气泡，则灌注溶液通过消融导管，经消融导管头端的盐水灌注孔为消融导管头端电极及消融组织进行降温，若气泡检测系统中检测到气泡，本发明可自动改变冲洗管路，同时控制灌注流量泵提高灌注溶液的流速，使灌注溶液含气泡段尽快由盐水冲洗出口排出。As shown in Figure 2, it is a schematic diagram of the principle of the perfusion process of automatic flushing of bubbles. The perfusion solution enters the bubble monitoring and flushing system from the infusion bag. If bubbles are not detected in the perfusion solution, the perfusion solution passes through the ablation catheter, and the saline perfusion hole at the head end of the ablation catheter is used to cool the electrode at the head end of the ablation catheter and the ablated tissue. If bubbles are detected in the bubble detection system, the present invention can automatically change the flushing pipeline and control the perfusion flow pump to increase the flow rate of the perfusion solution, so that the bubble segment of the perfusion solution is discharged from the saline flushing outlet as soon as possible.
上述过程通过核心系统控制模块实现自动化控制，其由一个嵌入式ARM处理器和RTOS操作系统组成，如图3所示，用于整合控制其余五大模块实现自动化操作。电机驱动及蠕动泵模块用于根据核心系统控制模块指令驱动蠕动泵调节控制流速，报警模块用于在灌注管路中监测到气泡出现时，对术者进行警示，警示方式包括声音警示、灯光警示等形式，操控模块包括触摸显示屏，触摸显示屏用于流量控制信号的手动输入以及流量速度等信息的反馈，气泡监测模块用于监测灌注管路中的气泡，若监测到气泡则触发报警模块报警，通讯模块外接消融仪，通讯模块根据导管消融工作状态自动配置不同的灌注流速参数。The above process is automatically controlled by the core system control module, which consists of an embedded ARM processor and an RTOS operating system, as shown in Figure 3, and is used to integrate and control the remaining five modules to achieve automatic operation. The motor drive and peristaltic pump module is used to drive the peristaltic pump to adjust the control flow rate according to the instructions of the core system control module. The alarm module is used to warn the operator when bubbles are detected in the perfusion pipeline. The warning methods include sound warnings, light warnings, etc. The control module includes a touch screen, which is used for manual input of flow control signals and feedback of information such as flow rate. The bubble monitoring module is used to monitor bubbles in the perfusion pipeline. If bubbles are detected, the alarm module will be triggered to alarm. The communication module is externally connected to the ablation device. The communication module automatically configures different perfusion flow rate parameters according to the working status of the catheter ablation.
如图3所示灌注管路输出口上设置有二连二通分流通道，通过转换阀门控制灌注管路中溶液的流向，灌注管路利用转换阀门分别与气泡冲洗出口和导管盐水灌注口连接，所述的气泡冲洗出口用于将管路溶液中含气泡段排出灌注管路，所述的导管盐水灌注口用于连接导管盐水管接口，将灌注溶液泵入导管盐水通道，为导管头端的消融电极进行降温，当气泡监测模块监测到灌注管路中存在气泡时，核心系统控制模块将转换阀门调节至气泡冲洗管路，同时提高灌注管路流速，以将灌注管路内的气泡通过气泡冲洗管路快速排出，待气泡完全排除后自动将转换阀门打至导管盐水管道，同时降低灌注管路流速，术者可继续进行消融操作。As shown in FIG3 , a two-way two-way shunt channel is provided on the output port of the perfusion pipeline. The flow direction of the solution in the perfusion pipeline is controlled by a conversion valve. The perfusion pipeline is connected to the bubble flushing outlet and the catheter saline perfusion port respectively by using the conversion valve. The bubble flushing outlet is used to discharge the bubble-containing segment in the pipeline solution out of the perfusion pipeline. The catheter saline perfusion port is used to connect the catheter saline pipe interface to pump the perfusion solution into the catheter saline channel to cool the ablation electrode at the catheter head end. When the bubble monitoring module detects the presence of bubbles in the perfusion pipeline, the core system control module adjusts the conversion valve to the bubble flushing pipeline and increases the flow rate of the perfusion pipeline at the same time to quickly discharge the bubbles in the perfusion pipeline through the bubble flushing pipeline. After the bubbles are completely eliminated, the conversion valve is automatically opened to the catheter saline pipeline and the flow rate of the perfusion pipeline is reduced, so that the operator can continue the ablation operation.
如图4所示为灌注管路装置，本发明的灌注管路装置为一次性使用的耗材设计，包括溶液袋插头、耐挤压软管、二联二通接口、导管盐水输出和冲洗管路输出5个部分：As shown in FIG4 , the perfusion pipeline device of the present invention is a disposable consumable design, including five parts: a solution bag plug, a squeeze-resistant hose, a two-way interface, a catheter saline output, and a flushing pipeline output:
其中，溶液袋插头直接插入到盐水溶液袋，从而提供溶液，主体为耐挤压软管，通过蠕动泵进行挤压灌注，软管末端有一个二连二通装置，一端接入到消融导管，另外一端接入到冲洗管路。Among them, the solution bag plug is directly inserted into the saline solution bag to provide solution. The main body is an extrusion-resistant hose, which is extruded and perfused by a peristaltic pump. There is a two-connected two-way device at the end of the hose, one end of which is connected to the ablation catheter and the other end is connected to the flushing pipeline.
盐水管路安装的结构，如图5所示。The structure of the brine pipeline installation is shown in Figure 5.
盐水泵通过蠕动泵按设定流速进行灌注，当正常灌注时，盐水泵通过二连二通结构，和导管盐水接口相连，当检测到气泡时，盐水泵把二连二通连接到冲洗管路，完成气泡冲洗。The saline pump uses a peristaltic pump to perfuse at a set flow rate. During normal perfusion, the saline pump is connected to the catheter saline interface through a two-way two-way structure. When bubbles are detected, the saline pump connects the two-way two-way to the flushing pipeline to complete the bubble flushing.
如图6所示，在正常盐水灌注过程中，气泡监测模块由超声波传感器实时监测灌注管路中的气泡，超声波传感器包括相对设置于灌注管路两侧的超声发生装置和超声接收装置，发生装置发射超声波穿过灌注管路及灌注管路内的生理盐水回到超声波接收装置，并由比较器对接收到的超声波信号进行比对。As shown in FIG6 , during normal saline perfusion, the bubble monitoring module uses an ultrasonic sensor to monitor the bubbles in the perfusion line in real time. The ultrasonic sensor includes an ultrasonic generator and an ultrasonic receiver relatively arranged on both sides of the perfusion line. The generator transmits ultrasonic waves through the perfusion line and the physiological saline in the perfusion line back to the ultrasonic receiver, and the comparator compares the received ultrasonic signals.
由于超声波在液体中的传播速度为1480m/s，在气体中的传播速度为344m/s，超声波在液体介质和气体介质中的传播速度两者存在非常大的差别，当灌注液体在管道内正常流动且没有混入气泡时，超声波接收装置监测到的超声波脉冲信号幅度足够大，可以经比较器得到与超声波共振频率一致的脉冲信号，从而不发出警报信号，当液体中混入气泡时，接收端接收到的超声波脉冲信号的幅度在该气泡通过传感器监测面时会衰减较大，此期间比较器输出为低，触发报警模块产生报警信号，当液体中混入气泡密度越多，或者单个气泡体积越大，接收端监测到的超声波脉冲信号衰减越大，通过设置比较器触发报警的参数，来调节气泡的监测精度。Since the propagation speed of ultrasound in liquid is 1480m/s, and the propagation speed in gas is 344m/s, there is a very large difference between the propagation speeds of ultrasound in liquid medium and gas medium. When the perfusion liquid flows normally in the pipeline and no bubbles are mixed in, the amplitude of the ultrasonic pulse signal monitored by the ultrasonic receiving device is large enough, and a pulse signal consistent with the ultrasonic resonance frequency can be obtained through the comparator, so that no alarm signal is issued. When bubbles are mixed in the liquid, the amplitude of the ultrasonic pulse signal received by the receiving end will be greatly attenuated when the bubble passes through the sensor monitoring surface. During this period, the comparator output is low, triggering the alarm module to generate an alarm signal. The more the density of bubbles mixed in the liquid, or the larger the volume of a single bubble, the greater the attenuation of the ultrasonic pulse signal monitored by the receiving end. The bubble monitoring accuracy can be adjusted by setting the parameters for the comparator to trigger the alarm.
具体地，本实施例中气泡的检测精度设置为0.4微升，当灌注管道内产生超过0.4微升的气泡时，报警模块产生报警，提示术者需要暂停消融进行冲洗气泡处理，排出灌注管内的气泡。Specifically, in this embodiment, the bubble detection accuracy is set to 0.4 microliters. When more than 0.4 microliters of bubbles are generated in the perfusion pipe, the alarm module generates an alarm to prompt the operator to suspend ablation to flush the bubbles and discharge the bubbles in the perfusion tube.
一个可行的实施方式中，电机驱动及蠕动泵模块流速控制分三种模式，如下：In a feasible implementation, the motor drive and peristaltic pump module flow rate control is divided into three modes, as follows:
1.低流速模式范围设置为：2ml/min到5ml/min；1. The low flow rate mode range is set to: 2ml/min to 5ml/min;
2.高流速模式范围设置为：6ml/min到60ml/min；2. The high flow rate mode range is set to: 6ml/min to 60ml/min;
3.冲洗模式流速设置为：100ml/min；3. The flow rate of flushing mode is set to: 100ml/min;
如图6所示为灌注流量泵整体结构图，灌注流量泵正面包括一个触摸显示屏，正常显示高速模式流速、低速模式流速和实时当前流速，其中触摸按键可以让用户选择高速或低速流量进行调整。灌注泵正面还包括3个控制按键，分别为电源按键、流速旋钮和停止按键，每个按键均带有LED灯，当按键使能时，LED灯自动点亮。蠕动泵模块包括蠕动泵门、蠕动泵及蠕动泵底座，灌注管路内的液体通过蠕动泵控制流速蠕动泵门上装有开关检测传感器，当泵门没有完全关闭时，会引发报警。As shown in Figure 6, the overall structure of the perfusion flow pump. The front of the perfusion flow pump includes a touch screen, which normally displays the high-speed mode flow rate, low-speed mode flow rate and real-time current flow rate. The touch button allows the user to select high-speed or low-speed flow for adjustment. The front of the perfusion pump also includes 3 control buttons, namely the power button, flow rate knob and stop button. Each button has an LED light. When the button is enabled, the LED light automatically lights up. The peristaltic pump module includes a peristaltic pump door, a peristaltic pump and a peristaltic pump base. The liquid in the perfusion pipeline controls the flow rate through the peristaltic pump. A switch detection sensor is installed on the peristaltic pump door. When the pump door is not completely closed, an alarm will be triggered.
本实施例中，灌注流速为双控制模式，如图6所示，在灌注泵使用时，由用户通过操控模块的触摸显示屏UI界面手动操作控制流速，也可以通过核心系统控制模块自动进行流速控制，当消融仪输出消融能量进行消融时，灌注泵流速自动设置为最高60ml/min，当消融结束后，流速设置自动调整为最高5ml/min,当气泡监测模块监测到灌注管道内含有气泡时，自动激活报警模块进行报警，核心系统控制模块通过通讯模块控制消融仪停止输出消融能量,同时将灌注管路系统切换至冲洗盐水管道，自动将流速调整为冲洗模式最高100ml/min，待含气泡段溶液排出灌注管道后，报警模块解除警报，核心系统控制模块将流速设置调整至最高5ml/min,同时灌注管路通道切换至导管盐水通道，用作正常的冷盐水消融灌注，通过上述方式，可实现灌注管路的自动气泡冲洗，消融过程中，等报警模块解除报警后，术者即可继续开始消融手术，无需其余复杂的操作即可实现自动化排气操作，极大提高了手术医生的手术效率。In this embodiment, the perfusion flow rate is a dual control mode, as shown in FIG6 . When the perfusion pump is in use, the user can manually control the flow rate through the touch screen UI interface of the control module, or the core system control module can automatically control the flow rate. When the ablation device outputs ablation energy for ablation, the perfusion pump flow rate is automatically set to a maximum of 60 ml/min. When the ablation is completed, the flow rate setting is automatically adjusted to a maximum of 5 ml/min. When the bubble monitoring module detects bubbles in the perfusion pipe, the alarm module is automatically activated to sound an alarm. The core system control module controls the ablation device to stop outputting ablation energy through the communication module, and at the same time The perfusion pipeline system switches to flushing the saline pipeline, and automatically adjusts the flow rate to a maximum of 100 ml/min in the flushing mode. After the bubble-containing solution is discharged from the perfusion pipeline, the alarm module cancels the alarm, and the core system control module adjusts the flow rate setting to a maximum of 5 ml/min. At the same time, the perfusion pipeline channel switches to the catheter saline channel for normal cold saline ablation perfusion. In the above manner, automatic bubble flushing of the perfusion pipeline can be achieved. During the ablation process, after the alarm module cancels the alarm, the operator can continue the ablation surgery. Automated exhaust operation can be achieved without other complicated operations, which greatly improves the surgical efficiency of the surgeon.
上述过程由核心系统控制模块分别自动控制蠕动泵调节注射流速，控制报警模块报警以及控制转换阀门的灌注导向，自动控制方式如下：The core system control module automatically controls the peristaltic pump to adjust the injection flow rate, controls the alarm module to alarm, and controls the perfusion guide of the conversion valve. The automatic control method is as follows:
灌注泵正常无气泡模式下，灌注管路通过转换阀门与导管盐水灌注管道导通，蠕动泵流速设置在低流速模式，当消融仪开始输出消融能量时，与消融仪连接的通讯模块反馈消融信号至核心系统控制模块，由核心系统控制模块自主控制蠕动泵将流速调节至设定好的高流速模式，加大生理盐水输出，降低消融电极和周围心肌组织的温度；当消融仪停止输出消融能量时，核心系统控制模块自动控制蠕动泵将流速调节回低流速模式；In the normal bubble-free mode of the perfusion pump, the perfusion line is connected to the catheter saline perfusion pipeline through the conversion valve, and the peristaltic pump flow rate is set in the low flow rate mode. When the ablation device starts to output ablation energy, the communication module connected to the ablation device feeds back the ablation signal to the core system control module, and the core system control module autonomously controls the peristaltic pump to adjust the flow rate to the set high flow rate mode, increase the output of physiological saline, and reduce the temperature of the ablation electrode and surrounding myocardial tissue; when the ablation device stops outputting ablation energy, the core system control module automatically controls the peristaltic pump to adjust the flow rate back to the low flow rate mode;
当气泡监测模块监测到灌注管路中存在气泡时，首先核心系统控制模块控制报警模块报警，如图3所示，报警灯闪烁同时发出声音报警，然后根据通讯模块反馈消融仪工作情况，若消融仪正在输出消融能量，由核心系统控制模块控制消融仪停止消融能量输出，触摸显示屏当前流速显示处UI显示灌注管道存在气泡图示如图7所示。When the bubble monitoring module detects the presence of bubbles in the perfusion pipeline, the core system control module first controls the alarm module to sound an alarm, as shown in Figure 3. The alarm light flashes and a sound alarm is emitted. Then, the communication module feedbacks the working status of the ablation device. If the ablation device is outputting ablation energy, the core system control module controls the ablation device to stop outputting ablation energy. The UI at the current flow rate display on the touch screen displays that there are bubbles in the perfusion pipeline, as shown in Figure 7.
最后，控制转换阀门将灌注管路转换阀门通路调整至冲洗管路，如图8所示，控制蠕动泵将流速调节至冲洗模式，触摸显示屏UI显示盐水冲洗模式，提示医生目前正在冲洗气泡，以最快的速度将气泡段排出灌注管路，直至气泡监测模块不再监测到气泡，自动关闭报警模块报警，控制蠕动泵将流速调整至低流速模式，将转换阀门拨回导管盐水灌注管道，术者可继续消融手术。Finally, the conversion valve is controlled to adjust the perfusion line conversion valve passage to the flushing line, as shown in Figure 8, and the peristaltic pump is controlled to adjust the flow rate to the flushing mode. The touch screen UI displays the saline flushing mode, prompting the doctor that the bubbles are currently being flushed and the bubble segments are discharged from the perfusion line as quickly as possible until the bubble monitoring module no longer detects bubbles and automatically turns off the alarm module alarm. The peristaltic pump is controlled to adjust the flow rate to the low flow rate mode, and the conversion valve is turned back to the catheter saline perfusion line. The operator can continue the ablation operation.
本实施例中，灌注泵外接有输液袋，输液袋为多级串联构成，以提高盐水存储量，减少更换盐水袋频率，提高手术效率，如图所示生理盐水由输液袋进入蠕动泵，由蠕动泵控制生理盐水以设定的流速进入气泡传感器，最后从导管盐水灌注口离开灌注泵进入导管盐水管，气泡传感器输出端通过转换阀门连接有两个不同的盐水通道，分别是导管盐水管道和冲洗盐水管道，气泡传感器监测到灌注管道内含气泡时，由核心系统控制模块控制二通转换阀门将导管盐水管道关闭，将冲洗盐水管道打开，使灌注管道内的气泡从冲洗盐水管道排出灌注泵。In this embodiment, the perfusion pump is externally connected to an infusion bag, which is a multi-stage series structure to increase the saline storage capacity, reduce the frequency of replacing saline bags, and improve surgical efficiency. As shown in the figure, physiological saline enters the peristaltic pump from the infusion bag, and the peristaltic pump controls the physiological saline to enter the bubble sensor at a set flow rate, and finally leaves the perfusion pump from the catheter saline perfusion port and enters the catheter saline pipe. The output end of the bubble sensor is connected to two different saline channels through a conversion valve, namely the catheter saline pipe and the flushing saline pipe. When the bubble sensor detects that the perfusion pipe contains bubbles, the core system control module controls the two-way conversion valve to close the catheter saline pipe and open the flushing saline pipe, so that the bubbles in the perfusion pipe are discharged from the flushing saline pipe to the perfusion pump.
本发明第三实施例，一种手术机器人，该手术机器人包括如第一实施例或第二实施例中提供的自动冲洗气泡的灌注装置，用于响应于术者操作以完成消融手术处理。A third embodiment of the present invention is a surgical robot, which includes an automatic bubble flushing irrigation device as provided in the first embodiment or the second embodiment, and is used to respond to the operator's operation to complete the ablation surgical treatment.
通过具体实施方式的说明，应当可对本发明为达成预定目的所采取的技术手段及功效得以更加深入且具体的了解，然而所附图示仅是提供参考与说明之用，并非用来对本发明加以限制。Through the description of the specific implementation methods, a deeper and more specific understanding of the technical means and effects adopted by the present invention to achieve the predetermined purpose should be obtained. However, the accompanying drawings are only for reference and illustration purposes and are not intended to limit the present invention.
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| CN202311601036.0ACN117861000A (en) | 2023-11-28 | 2023-11-28 | Automatic wash filling device of bubble |
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