CN111714202A

Movatterモバイル変換

Info

Publication number: CN111714202A
Application number: CN201910203845.3A
Authority: CN
Inventors: 刘珈; 鲁旭尉; 武眀花; 张逸婷
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-03-18
Filing date: 2019-03-18
Publication date: 2020-09-29

Abstract

Translated fromChinese

本发明一种肿瘤消融监测组件包括主体，其内开设有监测通道；以及监测配件，监测配件装配于监测通道内；主体用于消融操作时深入人体的病灶区域，监测配件用于获取靶区组织细胞中反应靶区组织细胞灭活状态和/或正常组织细胞情况的监测参数。本发明肿瘤消融监测组件、肿瘤消融装置以及肿瘤消融系统，通过监测配件获取靶区组织细胞中反应靶区组织细胞灭活状态的监测参数，以便于医护人员在消融过程中靶区内肿瘤组织细胞的灭活状态进行实时判断，避免消融操作过程中，造成或正常组织损伤过多、或预期消融区域范围不足。

A tumor ablation monitoring assembly of the present invention includes a main body, in which a monitoring channel is opened; and monitoring accessories, the monitoring accessories are assembled in the monitoring channel; the main body is used to penetrate into the lesion area of the human body during ablation operation, and the monitoring accessories are used to obtain target tissue. Monitoring parameters in cells that reflect the inactivation state of histiocytes in the target area and/or the condition of normal histiocytes. The tumor ablation monitoring component, the tumor ablation device and the tumor ablation system of the present invention can obtain monitoring parameters in the tissue cells in the target area reflecting the inactivation state of the tissue cells in the target area through the monitoring accessories, so as to facilitate medical staff in the ablation process of the tumor tissue cells in the target area. The inactivation state is judged in real time to avoid excessive damage to normal tissue or insufficient range of the expected ablation area during the ablation operation.

Description

Translated fromChinese

肿瘤消融监测组件、装置及系统Tumor ablation monitoring components, devices and systems

技术领域technical field

本发明涉及医疗器械领域，特别涉及一种用于肿瘤治疗的肿瘤消融监测组件、装置及系统。The present invention relates to the field of medical devices, in particular to a tumor ablation monitoring component, device and system for tumor treatment.

背景技术Background technique

目前肿瘤(例如脑肿瘤等)治疗手段主要为外科手术，其次是放疗和化疗。其中，手术治疗所花费的时间长、失血多且开放手术感染机会大、治疗费用高；放疗有部分病人不敏感，且放疗有较多副作用；大部分肿瘤通常对化疗不敏感，全身副作用明显。针对上述问题，国内外有人尝试使用微波、射频、激光等消融治疗以克服上述三种治疗的副作用。At present, the treatment of tumors (such as brain tumors, etc.) is mainly surgery, followed by radiotherapy and chemotherapy. Among them, surgery takes a long time, loses a lot of blood, and open surgery has a high chance of infection and high treatment costs; some patients are insensitive to radiotherapy, and radiotherapy has many side effects; most tumors are usually insensitive to chemotherapy, with obvious systemic side effects. In view of the above problems, some people at home and abroad have tried to use microwave, radio frequency, laser and other ablation treatments to overcome the side effects of the above three treatments.

消融治疗是指通过高温或超低温直接造成治疗区域组织发生凝固性坏死，达到外科手术切除的效果。其中，消融治疗的主要优点为：不用开刀，可以采取一次、或多次适形治疗，术后恢复快，总体治疗费用低，同时可以激活免疫系统；无辐射、无化学损伤，不会出现放、化疗遇到的肿瘤不敏感问题，可以重复治疗，也可以实施有计划的分段治疗；对于早期病变可以根治性治疗，对晚期病变可以姑息治疗，以有效减少肿瘤负荷。同时可以配合放疗、化疗等其他治疗手段，不会与其他治疗方法相冲突。Ablation therapy refers to the coagulation necrosis of the tissue in the treatment area directly caused by high temperature or ultra-low temperature to achieve the effect of surgical resection. Among them, the main advantages of ablation therapy are: no surgery, one or more conformal treatments can be taken, postoperative recovery is fast, the overall treatment cost is low, and the immune system can be activated at the same time; no radiation, no chemical damage, no radiation . For the problem of insensitivity of tumors encountered by chemotherapy, the treatment can be repeated, or a planned staged treatment can be implemented; radical treatment can be performed for early lesions, and palliative treatment can be used for advanced lesions to effectively reduce the tumor burden. At the same time, it can be combined with other treatment methods such as radiotherapy and chemotherapy, and will not conflict with other treatment methods.

在消融治疗前，可以利用CT(Computed Tomography)、MRI(Magnetic ResonanceImaging)等影像三维重建技术，建立仿真模体，以生物机体的生物效应相同为准则，利用仿真模体精准模拟肿瘤消融的过程，医务工作者据此可以确保治疗方案最优。但治疗方案执行的过程中无法避免各种误差，肿瘤生长在人体体内，治疗过程中无法直接监测计划治疗靶区内肿瘤组织细胞灭活状态，无法实时判断靶区组织是否完全灭活，造成或正常组织损伤过多、或预期消融区域范围不足。Before the ablation treatment, three-dimensional image reconstruction technologies such as CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) can be used to establish a simulation phantom. Based on the same biological effect of the biological body, the simulation phantom can be used to accurately simulate the process of tumor ablation. This allows healthcare workers to ensure optimal treatment options. However, various errors cannot be avoided in the implementation of the treatment plan. The tumor grows in the human body. During the treatment process, it is impossible to directly monitor the inactivation state of tumor tissue cells in the planned treatment target area, and it is impossible to judge in real time whether the target tissue is completely inactivated, causing or Excessive damage to normal tissue, or insufficient area of expected ablation.

发明内容SUMMARY OF THE INVENTION

基于此，有必要针对传统消融设备在消融过程中或正常组织损伤过多、或消融预期不足的问题，提供一种提高消融过程中消融预期效果且能控制正常组织损伤的肿瘤消融组件、装置及系统。Based on this, it is necessary to provide a tumor ablation component, device and device that can improve the expected effect of ablation during the ablation process and can control the normal tissue damage, aiming at the problem that the traditional ablation device is damaged too much or the normal tissue is damaged during the ablation process, or the ablation expectation is insufficient. system.

一种肿瘤消融监测组件，包括主体，其内开设有监测通道；以及监测配件，所述监测配件装配于所述监测通道内；A tumor ablation monitoring assembly, comprising a main body with a monitoring channel opened therein; and a monitoring accessory, the monitoring accessory being assembled in the monitoring channel;

其中，所述主体用于消融操作时深入人体的病灶区域，所述监测配件用于获取组织细胞中反应靶区组织细胞灭活状态和/或正常组织细胞损伤情况的监测参数。Wherein, the main body is used to penetrate into the focal area of the human body during the ablation operation, and the monitoring accessory is used to obtain monitoring parameters in the tissue cells that reflect the inactivation state of the tissue cells in the target area and/or the damage of normal tissue cells.

在其中一个实施例中，所述监测配件包括物质探测识别件；所述物质探测识别件用于探测及识别组织细胞消融后所产生的物质成分。In one of the embodiments, the monitoring accessory includes a substance detection and identification part; the substance detection and identification part is used to detect and identify the substance components produced after the tissue cells are ablated.

在其中一个实施例中，所述物质探测识别件包括光学传导纤维及分析器，所述主体上开设有若干连通所述监测通道的透光孔，所述光学传导纤维的一端伸入所述监测通道内，所述光学传导纤维的另一端与所述分析器通讯连接。In one embodiment, the substance detection and identification element includes an optical conducting fiber and an analyzer, the main body is provided with a plurality of light-transmitting holes communicating with the monitoring channel, and one end of the optical conducting fiber extends into the monitoring Inside the channel, the other end of the optically conductive fiber is communicatively connected to the analyzer.

在其中一个实施例中，所述监测配件还包括温度探针，所述温度探针用于获取靶区组织细胞的当前消融温度，以确定消融操作在当前消融温度下的持续时长和/或调整所述消融针能量输出方向。In one embodiment, the monitoring accessory further includes a temperature probe, the temperature probe is used to obtain the current ablation temperature of the tissue cells in the target area, so as to determine the duration and/or adjustment of the ablation operation at the current ablation temperature The ablation needle energy output direction.

在其中一个实施例中，所述肿瘤消融监测组件包括驱动件，所述驱动件与所述监测配件传动连接，以控制所述监测配件进入所述监测通道的深度。In one embodiment, the tumor ablation monitoring assembly includes a driving member, the driving member is drivingly connected with the monitoring accessory to control the depth of the monitoring accessory entering the monitoring channel.

在其中一个实施例中，所述主体内开设有一条或一条以上所述监测通道；In one of the embodiments, one or more monitoring channels are opened in the main body;

当所述监测通道为一条以上时，所述监测配件能够在手动或所述驱动件驱动下自动在相同或不同的时间选择进入不同的所述监测通道、以及进入对应所述监测通道的深度。When there are more than one monitoring channel, the monitoring accessory can be manually or automatically driven by the driving element to select different monitoring channels and depths corresponding to the monitoring channels at the same or different times.

一种肿瘤消融装置，包括针套、嵌套于所述针套内的消融针以及监测配件，所述针套内开设有监测通道；所述监测配件装配于所述监测通道内，用于获取组织细胞中反应靶区组织细胞灭活状态和/或正常组织细胞损伤情况的监测参数。A tumor ablation device, comprising a needle sheath, an ablation needle nested in the needle sheath, and a monitoring accessory, wherein a monitoring channel is opened in the needle sheath; the monitoring accessory is assembled in the monitoring channel for obtaining Monitoring parameters in tissue cells that reflect the inactivation state of tissue cells in the target area and/or damage to normal tissue cells.

一种肿瘤消融系统，包括肿瘤消融装置及与所述肿瘤消融装置通讯连接的控制器，所述控制器根据所述监测参数确定所述靶区组织细胞的灭活状态和/或正常组织细胞损伤情况，并控制所述消融针的工作参数。A tumor ablation system, comprising a tumor ablation device and a controller in communication with the tumor ablation device, wherein the controller determines the inactivation state of tissue cells in the target area and/or normal tissue cell damage according to the monitoring parameters condition and control the operating parameters of the ablation needle.

在其中一个实施例中，当所述监测配件包括物质探测识别件，所述物质探测识别件用于获取消融后组织细胞产生的物质成分；所述控制器根据识别的物质成分与预设的生物效应数据进行比对，确定靶区组织细胞的灭活状态和/或正常组织细胞损伤情况；In one embodiment, when the monitoring accessory includes a substance detection and identification part, the substance detection and identification part is used to obtain the substance composition produced by the tissue cells after ablation; the controller is based on the identified substance composition and a preset biological composition. The effect data are compared to determine the inactivation state of tissue cells in the target area and/or the damage to normal tissue cells;

当所述监测配件包括温度探针时，所述温度探针用于获取靶区组织细胞的当前消融温度，所述控制器用于在靶区组织细胞的当前消融温度达到预定温度时，控制消融操作以当前消融温度继续持续预定时长和/或调整所述消融针能量输出方向。When the monitoring accessory includes a temperature probe, the temperature probe is used to obtain the current ablation temperature of the tissue cells in the target area, and the controller is used to control the ablation operation when the current ablation temperature of the tissue cells in the target area reaches a predetermined temperature Continue at the current ablation temperature for a predetermined period of time and/or adjust the direction of the ablation needle energy output.

在其中一个实施例中，所述控制器包括治疗计划存储模块、状态分析模块以及控制模块；In one embodiment, the controller includes a treatment plan storage module, a state analysis module and a control module;

所述治疗计划存储模块用于接受并存储消融治疗计划参数；The treatment plan storage module is used for accepting and storing parameters of the ablation treatment plan;

所述状态分析模块依据所述物质探测识别件识别的物质成分与预设的生物效应数据的比对结果，确定靶区组织细胞的灭活状态和/或正常组织细胞损伤情况；且所述状态分析模块还根据靶区组织细胞的灭活状态和/或正常组织细胞损伤情况与治疗计划比对分析得出治疗计划的执行情况，并实时给出消融治疗设备下一步的能量输出方案；The state analysis module determines the inactivation state of tissue cells in the target area and/or the damage to normal tissue cells according to the comparison result of the substance components identified by the substance detection identifier and the preset biological effect data; and the state The analysis module also compares and analyzes the treatment plan according to the inactivation state of tissue cells in the target area and/or the damage of normal tissue cells and the treatment plan, and provides the next energy output plan of the ablation treatment equipment in real time;

所述控制模块用于接收所述状态分析模块给出的下一步的能量输出方案，并根据能量输出方案调控消融针的能量输出。The control module is configured to receive the next energy output scheme given by the state analysis module, and regulate the energy output of the ablation needle according to the energy output scheme.

本发明肿瘤消融监测组件、肿瘤消融装置以及肿瘤消融系统，通过监测配件获取靶区组织细胞中反应靶区组织细胞灭活状态和/或正常组织细胞损伤情况的监测参数，以便于医护人员在消融过程中对靶区内肿瘤组织细胞的灭活状态和/或正常组织细胞损伤情况进行实时判断，避免消融操作过程中，造成或正常组织损伤过多、或消融预期不足。The tumor ablation monitoring assembly, the tumor ablation device and the tumor ablation system of the present invention can obtain monitoring parameters in the target area tissue cells reflecting the inactivation state of the target area tissue cells and/or the normal tissue cell damage through the monitoring accessories, so as to facilitate medical staff during ablation During the process, the inactivation state of tumor tissue cells in the target area and/or the damage of normal tissue cells are judged in real time, so as to avoid excessive damage to normal tissue or insufficient ablation expectations during the ablation operation.

附图说明Description of drawings

图1为本发明一实施例中肿瘤消融装置的结构示意图；FIG. 1 is a schematic structural diagram of a tumor ablation device according to an embodiment of the present invention;

图2为本发明另一实施例中肿瘤消融装置的结构示意图；FIG. 2 is a schematic structural diagram of a tumor ablation device in another embodiment of the present invention;

图3为本发明一实施例中肿瘤消融系统的模块示意图。FIG. 3 is a schematic block diagram of a tumor ablation system according to an embodiment of the present invention.

具体实施方式Detailed ways

为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳的实施例。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。In order to facilitate understanding of the present invention, the present invention will be described more fully hereinafter with reference to the related drawings. Preferred embodiments of the invention are shown in the accompanying drawings. However, the present invention may be embodied in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that a thorough and complete understanding of the present disclosure is provided.

需要说明的是，当元件被称为“固定于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的。It should be noted that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and similar expressions are used herein for illustrative purposes only.

除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terms used herein in the description of the present invention are for the purpose of describing specific embodiments only, and are not intended to limit the present invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

在对本发明中的消融设备及系统进行详细说明之前，首先对肿瘤的消融治疗的相关内容进行说明，以便于更佳地理解本发明中消融设备及系统的技术方案。Before the detailed description of the ablation device and system in the present invention, the relevant content of tumor ablation treatment is described first, so as to better understand the technical solutions of the ablation device and system in the present invention.

在影像技术(例如，超声、CT、MRI、脑血管造影等)引导下应用化学或加热的方法直接作用于局灶性实体肿瘤(单个或多个)，以根除或毁坏肿瘤组织的治疗方法被称为肿瘤的消融治疗。消融治疗可用于人体器官良/恶性实体肿瘤(例如，脑肿瘤、肝肿瘤、肺肿瘤、乳腺肿瘤)、原发性肿瘤以及转移性肿瘤等。Therapeutic methods that apply chemical or thermal methods under the guidance of imaging techniques (eg, ultrasound, CT, MRI, cerebral angiography, etc.) directly act on the focal solid tumor (single or multiple) to eradicate or destroy the tumor tissue. A treatment called ablation of the tumor. Ablation therapy can be used for benign/malignant solid tumors of human organs (eg, brain tumors, liver tumors, lung tumors, breast tumors), primary tumors, and metastatic tumors.

请参看图1，本发明一实施例中，肿瘤消融装置100通过介入导管深入肿瘤病灶区域，且肿瘤消融装置100包括针套10、嵌套于针套10内的消融针30以及肿瘤消融监测组件(即下述提及的主体或主体与监测配件53)。其中，介入导管用于提供治疗通道，并隔离治疗器械和人体腔道，避免治疗器械对人体腔道内其它部位造成损伤。消融针30用于对肿瘤组织执行消融操作，以对肿瘤组织进行治疗。肿瘤消融监测组件与消融针30一同深入人体的病灶区域，用于获取靶区组织细胞中反应靶区组织细胞灭活状态和/或正常组织细胞损伤情况的监测参数，以为医护人员对正在进行消融操作的靶区组织细胞的灭活状态提供判断依据，避免因不适当的操作造成靶区组织细胞消融不完全或消融过度而损伤正常组织细胞。优选地，本申请肿瘤消融装置100应用于实体肿瘤。Referring to FIG. 1 , in an embodiment of the present invention, atumor ablation device 100 penetrates into a tumor lesion area through an interventional catheter, and thetumor ablation device 100 includes aneedle sheath 10 , anablation needle 30 nested in theneedle sheath 10 , and a tumor ablation monitoring component (ie the body or body and monitoring accessory 53 referred to below). Among them, the interventional catheter is used to provide a treatment channel and isolate the treatment device from the human body cavity, so as to prevent the treatment device from causing damage to other parts in the human body cavity. Theablation needle 30 is used to perform an ablation operation on the tumor tissue to treat the tumor tissue. The tumor ablation monitoring component, together with theablation needle 30, penetrates deep into the lesion area of the human body, and is used to obtain monitoring parameters in the tissue cells of the target area that reflect the inactivation state of the tissue cells in the target area and/or the damage of normal tissue cells, so as to indicate that the medical staff is not sure about the ongoing ablation. The inactivation state of the tissue cells in the target area to be operated provides a basis for judgment, so as to avoid damage to normal tissue cells caused by incomplete or excessive ablation of the tissue cells in the target area due to improper operation. Preferably, thetumor ablation device 100 of the present application is applied to solid tumors.

肿瘤消融监测组件包括主体(图未示)及监测配件53。主体内开设有监测通道510，监测配件53装配于监测通道510，并跟随主体在消融操作时深入人体的病灶区域，用于获取靶区组织细胞中反应靶区组织细胞灭活状态的监测参数。The tumor ablation monitoring assembly includes a main body (not shown) and a monitoring accessory 53 . Amonitoring channel 510 is opened in the main body, and the monitoring accessories 53 are assembled in themonitoring channel 510 and follow the main body to penetrate into the lesion area of the human body during the ablation operation to obtain monitoring parameters in the target area tissue cells reflecting the inactivation state of the target area tissue cells.

在其中一个实施例中，针套10与肿瘤消融监测组件中主体分体设置，即针套10内除消融针30外还预留有装配通道，主体通过装配通道可拆卸地嵌入针套10内，且监测配件53装配于主体的监测通道510内，以与消融针30共同深入人体的病灶区域，实现对靶区组织细胞进行消融操作的同时对靶区组织细胞的灭活状态进行监测。In one embodiment, theneedle cover 10 and the main body of the tumor ablation monitoring assembly are provided separately, that is, in addition to theablation needle 30, an assembly channel is reserved in theneedle cover 10, and the main body is detachably embedded in theneedle cover 10 through the assembly channel , and the monitoring accessory 53 is assembled in themonitoring channel 510 of the main body, so as to penetrate into the lesion area of the human body together with theablation needle 30 to realize the ablation of the tissue cells in the target area and monitor the inactivation state of the tissue cells in the target area.

在其中另一个实施例中，针套10与肿瘤消融监测组件中主体一体设置，即针套10等同于肿瘤消融监测组件的主体。针套10内除消融针30外，预留有监测通道510，监测配件53装配于监测通道510内，以与消融针30共同深入人体的病灶区域，实现对靶区组织细胞进行消融操作的同时对靶区组织细胞的灭活状态进行监测。In another embodiment, theneedle cover 10 is integrated with the main body of the tumor ablation monitoring assembly, that is, theneedle cover 10 is equivalent to the main body of the tumor ablation monitoring assembly. In addition to theablation needle 30, amonitoring channel 510 is reserved in theneedle cover 10, and the monitoring accessory 53 is assembled in themonitoring channel 510, so as to penetrate into the lesion area of the human body together with theablation needle 30, and realize the ablation operation on the tissue cells in the target area at the same time. Monitor the inactivation state of tissue cells in the target area.

应当指出来的是，下述实施例的记载的“主体”可为与针套10分体设置的部件，亦可为与针套10一体设置(此时即等同于针套10)的部件，在下面的记载中均不做特定的限定。It should be pointed out that the "main body" described in the following embodiments may be a component provided separately from theneedle cover 10, or a component provided integrally with the needle cover 10 (in this case, it is equivalent to the needle cover 10), In the following description, no specific limitation is made.

在其中一个实施例中，监测参数包括对靶区组织细胞进行消融操作时的当前消融温度。具体地，监测配件53包括温度探针，温度探针装配于监测通道510内，主体(当两者一体设置时，主体与针套10两者等同)、或主体和针套10(两者分体设置时)均为导热材料制成，使得装配于监测通道510内的温度探针可通过主体、或主体和针套10探测消融针30对靶区组织细胞进行消融操作时的当前消融温度。此时，通过探测所得到的当前消融温度，可确定消融操作的持续时长和/或调整消融针30能量输出方向(例如通过旋转激光以改变消融针30的能量输出方向)，以匹配性的保证合适消融能量的输出。In one embodiment, the monitoring parameter includes the current ablation temperature during the ablation operation on the tissue cells of the target area. Specifically, the monitoring accessory 53 includes a temperature probe, the temperature probe is assembled in themonitoring channel 510, the main body (when the two are integrally arranged, the main body and theneedle cover 10 are equivalent), or the main body and the needle cover 10 (the two are separated from each other) The temperature probe assembled in themonitoring channel 510 can detect the current ablation temperature when theablation needle 30 performs the ablation operation on the tissue cells in the target area through the main body, or the main body and theneedle cover 10 . At this time, by detecting the obtained current ablation temperature, the duration of the ablation operation can be determined and/or the energy output direction of theablation needle 30 can be adjusted (for example, by rotating the laser to change the energy output direction of the ablation needle 30), to ensure the matching Output of suitable ablation energy.

请参看图2，在其中另一个实施例中，监测参数包括靶区组织细胞消融后所产生的物质成分。具体地，监测配件53包括物质探测识别件，物质探测识别件装配于监测通道510内，用于探测及识别靶区组织细胞消融后所产生的物质成分。Referring to FIG. 2 , in another embodiment, the monitoring parameter includes the substance composition produced after the ablation of the tissue cells in the target area. Specifically, the monitoring accessory 53 includes a substance detection and identification part, and the substance detection and identification part is assembled in themonitoring channel 510 and used to detect and identify the substance components generated after the ablation of the tissue cells in the target area.

本申请人在研究中发现，肿瘤组织和正常组织的生物、化学成分不同及组织结构改变，在接受消融治疗后不管是被微波、射频消融或经激光消融毁损后，组织成分及结构会产生改变，改变后的组织成分可以通过功能近红外光谱分析、拉曼散射光谱分析、等离子体分析等技术进行区别。其中，探测识别的物质为消融毁损后所产生的物质成分，物质可以为原位物质、体内残存物、亦可为负压吸取出或机械运送体外的废弃物或气体等。其中，机械运送是指通过机械手段直接取出病灶区的肿瘤组织细胞、废弃物或气体等，例如通过机械部件直接深入病灶区掏取肿瘤组织细胞、废弃物或气体等。The applicant found in the research that the biological and chemical components of tumor tissue and normal tissue are different and the tissue structure changes. After receiving ablation treatment, whether it is damaged by microwave, radio frequency ablation or laser ablation, the tissue composition and structure will change. , the altered tissue composition can be distinguished by techniques such as functional near-infrared spectroscopy, Raman scattering spectroscopy, and plasma analysis. Among them, the detected and identified substances are the material components produced after ablation and damage. The substances can be in-situ substances, body residues, or wastes or gases that are sucked out by negative pressure or mechanically transported outside the body. Among them, mechanical transport refers to the direct removal of tumor tissue cells, waste or gas, etc. in the lesion area by mechanical means, for example, the tumor tissue cells, waste or gas, etc. are directly extracted from the lesion area through mechanical components.

因此，在本具体实施例中，物质探测识别件包括光学传导纤维及分析器，主体上开设有若干连通监测通道510的透光孔512，光学传导纤维的一端伸入监测通道510内，光学传导纤维的另一端与分析器通讯连接；通过透光孔512获得消融毁损后所产生的物质成分的光谱，确定其化学组成与相对含量后，与生物效应进行比对，以根据比对结果在治疗过程中实时探测识别靶区组织细胞的灭活状态和/或正常组织细胞损伤情况，并根据当于靶区组织细胞的灭活状态和/或正常组织细胞损伤情况调控下一步中消融针30的能量输出，确保整个治疗准确无误。Therefore, in this specific embodiment, the substance detection and identification element includes an optical conducting fiber and an analyzer, the main body is provided with a number of light-transmittingholes 512 that communicate with themonitoring channel 510, one end of the optical conducting fiber extends into themonitoring channel 510, and the optical conducting fiber extends into themonitoring channel 510. The other end of the fiber is connected in communication with the analyzer; the spectrum of the material composition produced after ablation and damage is obtained through the light-transmittinghole 512, and after determining its chemical composition and relative content, it is compared with the biological effect, and the treatment is performed according to the comparison result. During the process, the inactivation state of tissue cells in the target area and/or the damage of normal tissue cells are detected and identified in real time, and theablation needle 30 is regulated in the next step according to the inactivated state of tissue cells in the target area and/or the damage of normal tissue cells. The energy output ensures that the entire treatment is accurate.

可以理解地，在具体应用当中，监测配件53可仅设置温度探针与物质探测识别件中一者或两者，对应地，主体内监测通道510的数量可为一条或一条以上，在此不作限定。此外，物质探测识别件所用技术，可以是如功能近红外、拉曼、等离子体分析、双光子中一种或多种。It can be understood that, in a specific application, the monitoring accessory 53 may only be provided with one or both of the temperature probe and the substance detection identification member. Correspondingly, the number ofmonitoring channels 510 in the main body may be one or more, which is not made here. limited. In addition, the technology used in the substance detection and identification element may be one or more of functional near-infrared, Raman, plasma analysis, and two-photon.

进一步地，肿瘤消融监测组件包括驱动件55，在消融操作过程中，驱动件位于人体外，并与监测配件53传动连接，以控制监测配件53进入监测通道510的深度。具体地，驱动件55可为例如小型步进电机等，通过对步进电机的控制，驱动监测配件53相对监测通道510进退，以实现对不同病灶区域进行监测。可以理解地，在其它一些实施例中，驱动件55亦可为其它驱动结构，在此不作限定。甚至，在其它另一些实施例中，驱动件55可被取消，通过手动的方式对监测配件53深入监测通道510内的深度进行控制，在此不作限定。Further, the tumor ablation monitoring assembly includes a drivingmember 55 . During the ablation operation, the driving member is located outside the human body and is drivingly connected with the monitoring accessory 53 to control the depth of the monitoring accessory 53 entering themonitoring channel 510 . Specifically, the drivingmember 55 can be, for example, a small stepping motor, etc., through the control of the stepping motor, the monitoring accessory 53 is driven to advance and retreat relative to themonitoring channel 510 to monitor different lesion areas. It can be understood that, in other embodiments, the drivingmember 55 may also be other driving structures, which are not limited herein. Even, in other other embodiments, the drivingmember 55 can be eliminated, and the depth of the monitoring accessory 53 into themonitoring channel 510 can be controlled manually, which is not limited herein.

更进一步地，主体上设置有对应监测配件53进出监测通道510深度的刻度，以便于医护人员直观观看。Furthermore, the main body is provided with a scale corresponding to the depth of the monitoring accessory 53 entering and exiting themonitoring channel 510, so as to facilitate the intuitive viewing of the medical staff.

再进一步地，主体内开设有一条或一条以上监测通道510；当监测通道510为一条以上时，监测配件53能够在手动或驱动件55驱动下自动在相同或不同的时间选择进入不同的监测通道510、以及进入对应该监测通道510的深度。Still further, one ormore monitoring channels 510 are opened in the main body; when there are more than onemonitoring channels 510, the monitoring accessories 53 can be automatically selected to enter different monitoring channels at the same or different times under the driving of manual operation or the drivingmember 55. 510 , and enter the depth corresponding to themonitoring channel 510 .

请参看图3，本申请还提供一种肿瘤消融系统200，肿瘤消融系统200包括肿瘤消融装置100及与肿瘤消融装置100通讯连接的控制器201。控制器201根据监测参数确定靶区组织细胞的灭活状态和/或正常组织细胞损伤情况，并控制消融针30的工作参数。其中，消融针30的工作参数包括消融温度、消融时长等。Referring to FIG. 3 , the present application further provides atumor ablation system 200 , thetumor ablation system 200 includes atumor ablation device 100 and acontroller 201 communicatively connected to thetumor ablation device 100 . Thecontroller 201 determines the inactivated state of the tissue cells in the target area and/or the damage of normal tissue cells according to the monitoring parameters, and controls the working parameters of theablation needle 30 . The working parameters of theablation needle 30 include ablation temperature, ablation duration, and the like.

控制器201包括治疗计划接受模块2010，用于接受及存储消融治疗计划的数据。具体地，患者治疗前，治疗计划接受模块2010接受与存储的患者消融治疗计划的数据，包括患者的姓名、体位、肿瘤部位、分类、大小、形状、使用消融设备的型号、治疗方案等。Thecontroller 201 includes a treatmentplan acceptance module 2010 for accepting and storing data of the ablation treatment plan. Specifically, before the patient is treated, the treatmentplan acceptance module 2010 accepts and stores the data of the patient's ablation treatment plan, including the patient's name, body position, tumor location, classification, size, shape, model of ablation equipment used, treatment plan, etc.

在其中一个实施例中，当监测配件53包括温度探针时，温度探针用于获取靶区组织细胞的当前消融温度，控制器201用于在靶区组织细胞的当前消融温度达到预定温度时，控制消融操作以当前消融温度继续持续预定时长和/或调整30消融针能量输出方向，以匹配性的保证合适消融能量的输出。In one embodiment, when the monitoring accessory 53 includes a temperature probe, the temperature probe is used to obtain the current ablation temperature of the tissue cells in the target area, and thecontroller 201 is used to obtain a predetermined temperature when the current ablation temperature of the tissue cells in the target area reaches a predetermined temperature. , controlling the ablation operation to continue at the current ablation temperature for a predetermined period of time and/or adjusting 30 the energy output direction of the ablation needle to match the output of the appropriate ablation energy.

在其中另一个实施例中，当监测配件53包括物质探测识别件时，物质探测识别件装配于监测通道510内，用于探测及识别靶区组织细胞消融后所产生的物质成分。具体地，物质探测识别件包括光学传导纤维及分析器，主体上开设有若干连通监测通道510的透光孔512，光学传导纤维的一端伸入监测通道510内，光学传导纤维的另一端与分析器通讯连接；通过透光孔512获得消融毁损后所产生的物质成分的光谱，确定其化学组成与相对含量。In another embodiment, when the monitoring accessory 53 includes a substance detection identification member, the substance detection identification member is assembled in themonitoring channel 510 for detecting and identifying the substance components generated after the ablation of the tissue cells in the target area. Specifically, the substance detection and identification element includes an optical conducting fiber and an analyzer. The main body is provided with a number of light-transmittingholes 512 that communicate with themonitoring channel 510. One end of the optical conducting fiber extends into themonitoring channel 510, and the other end of the optical conducting fiber is connected to the analyzer. through the light-transmittinghole 512 to obtain the spectrum of the material composition produced after ablation and damage, and determine its chemical composition and relative content.

对应地，控制器201包括状态分析模块2012，状态分析模块2012已经预存等离子体分析技术的生物效应数据。状态分析模块2012依据物质探测识别件所获得的数据，与生物效应进行比对，确定靶区组织细胞的灭活状态和/或正常组织细胞损伤情况。同时，状态分析模块2012还根据靶区组织细胞的灭活状态和/或正常组织细胞损伤情况与治疗计划比对分析得出治疗计划的执行情况，并实时给出消融治疗设备下一步的能量输出方案。Correspondingly, thecontroller 201 includes astate analysis module 2012, and thestate analysis module 2012 has pre-stored the biological effect data of the plasma analysis technology. Thestate analysis module 2012 compares the data obtained by the substance detection and identification element with the biological effect to determine the inactivation state of tissue cells in the target area and/or the damage to normal tissue cells. At the same time, thestate analysis module 2012 also compares and analyzes the treatment plan according to the inactivation state of the tissue cells in the target area and/or the damage of normal tissue cells and the treatment plan, and provides the next energy output of the ablation treatment device in real time. Program.

控制器201包括与消融针30通讯连接的控制模块2014，控制模块2014用于接收状态分析模块2012给出的下一步的能量输出方案，并根据能量输出方案调控消融针30的能量输出。Thecontroller 201 includes acontrol module 2014 connected in communication with theablation needle 30 . Thecontrol module 2014 is configured to receive the next energy output scheme given by thestate analysis module 2012 and regulate the energy output of theablation needle 30 according to the energy output scheme.

可以理解地，在其它一些实施例中，监测配件53可仅设置温度探针与物质探测识别件中一者或两者，在此不作限定。It can be understood that, in some other embodiments, the monitoring accessory 53 may only be provided with one or both of the temperature probe and the substance detection identification element, which is not limited herein.

下面以肿瘤消融系统200对脑肿瘤进行消融治疗为例，对肿瘤消融系统200的操作过程进行详细说明：The operation process of thetumor ablation system 200 is described in detail below by taking thetumor ablation system 200 for ablation treatment of a brain tumor as an example:

事先，采集患者影像学资料(MRI/CT/脑血管造影等)，将图像信号导入神经导航系统，通过影像学(MRI/CT/脑血管造影等)图像分析并进行3D重建；通过仿真技术+3D技术，制定微创消融治疗计划(确定进针部位、方向、深度，根据消融范围确定治疗参数，例如功率、时间等)，并将消融治疗计划存储至治疗计划接受模块2010内。In advance, collect the patient's imaging data (MRI/CT/cerebral angiography, etc.), import the image signal into the neuronavigation system, analyze and perform 3D reconstruction through imaging (MRI/CT/cerebral angiography, etc.); 3D technology, formulate a minimally invasive ablation treatment plan (determine the needle insertion site, direction, depth, and determine treatment parameters according to the ablation range, such as power, time, etc.), and store the ablation treatment plan in the treatmentplan acceptance module 2010.

其次，开启肿瘤消融系统200，消毒麻醉后，采用神经导航系统引导，在肿瘤中心颅骨体外投影处定位并标记、钻孔破骨，使用穿刺针穿破脑膜，在神经导航仪指引下将引导穿刺针插向颅内预定诊治目标处，以进行后续消融操作。Secondly, thetumor ablation system 200 is turned on, after disinfection and anesthesia, the neuronavigation system is used to guide, locate and mark and drill the osteoclast at the external projection of the skull of the tumor center, use a puncture needle to puncture the meninges, and guide the puncture under the guidance of the neuronavigator. The needle is inserted into the predetermined intracranial target for diagnosis and treatment for subsequent ablation operations.

其中，在消融过程中，物质探测识别件探测消融毁损后所产生的物质成分的光谱，确定其化学组成与相对含量后并传送至状态分析模块202；状态分析模块2012依据物质探测识别件所获得的数据，与生物效应进行比对，确定靶区组织细胞的灭活状态和/或正常组织细胞损伤情况；且还根据靶区组织细胞的灭活状态和/或正常组织细胞损伤情况与治疗计划比对分析得出治疗计划的执行情况，并实时给出消融治疗设备下一步的能量输出方案至控制模块2014；控制模块2014接收状态分析模块2012给出的下一步的能量输出方案，并根据能量输出方案调控消融针30的能量输出，以确保治疗计划的精准执行。Wherein, during the ablation process, the substance detection and identification element detects the spectrum of the material composition generated after the ablation and damage, determines its chemical composition and relative content, and transmits it to the state analysis module 202; thestate analysis module 2012 obtains according to the material detection and identification element Compared with the biological effects, the inactivation state of target tissue cells and/or normal tissue cell damage is determined; and the inactivation state of target tissue cells and/or normal tissue cell damage and treatment plan are also Comparing and analyzing the execution of the treatment plan, and giving the next energy output plan of the ablation therapy device in real time to thecontrol module 2014; thecontrol module 2014 receives the next energy output plan given by thestate analysis module 2012, and according to the energy The output scheme regulates the energy output of theablation needle 30 to ensure accurate execution of the treatment plan.

本发明肿瘤消融监测组件、肿瘤消融装置100以及肿瘤消融系统200，通过监测配件53获取靶区组织细胞中反应靶区组织细胞灭活状态和/或正常组织细胞损伤情况的监测参数，以便于医护人员在消融过程中靶区内肿瘤组织细胞的灭活状态和/或正常组织细胞损伤情况进行实时判断，避免消融操作过程中，造成或正常组织损伤过多、或消融预期不足。The tumor ablation monitoring assembly, thetumor ablation device 100 and thetumor ablation system 200 of the present invention can obtain monitoring parameters in the tissue cells in the target area that reflect the inactivation state of the target area tissue cells and/or the damage of normal tissue cells through the monitoring accessory 53, so as to facilitate medical care During the ablation process, the personnel will make real-time judgment on the inactivation state of tumor tissue cells and/or the damage of normal tissue cells in the target area, so as to avoid excessive damage to normal tissue or insufficient ablation expectations during the ablation operation.

以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be regarded as the scope described in this specification.

以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are more specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can also be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the appended claims.