WO2021228122A1 - Ablation catheter for image-guided ablation, and ablation device - Google Patents

Abstract

Disclosed in the present invention are an ablation catheter for image-guided ablation, and an ablation device. The ablation catheter comprises an elongated catheter body, a first catheter branch and a second catheter branch being provided at a distal end of the catheter body; an ablation probe is provided at a distal end of the first catheter branch, and a temperature measurement probe is provided at a distal end of the second catheter branch; and a control handle is provided at a proximal end of the catheter body. In the ablation catheter, while an ablation probe is placed in a tissue to be ablated and for ablation, a tiny temperature measurement probe can be positioned, in a minimally invasive manner, at a boundary of the tissue to be ablated and a normal tissue, so as to accurately measure, in real time, the actual temperature of a boundary region of the tissue to be ablated, and the temperature of the boundary region of the tissue to be ablated can be accurately measured, thereby precisely controlling the implementation of an ablation procedure.

Description

Translated fromChinese

用于图像引导消融术的消融导管和消融设备Ablation catheter and ablation device for image-guided ablation技术领域Technical field

本发明涉及一种用于图像引导消融术的消融导管，同时涉及包括上述消融导管的消融设备，属于医疗器械领域。The present invention relates to an ablation catheter used for image-guided ablation, and at the same time relates to an ablation device including the ablation catheter, belonging to the field of medical devices.

背景技术Background technique

肿瘤热疗是指利用某种加热方法把肿瘤组织加热至超过其耐热温度以杀死癌细胞,其包括温热疗法和高温热凝固法两种。温热疗法是加热肿瘤至42.5～45℃并保持一定时间(通常为数分钟到几十分钟),抑制肿瘤组织的生长以达到治疗癌症的目的。高温热凝固法是将肿瘤组织加热到较高的温度(一般为60℃即刻,或54℃保持一分钟)而使肿瘤完全性坏死。近年来,随着微波技术,特别是植入式微波技术、射频技术及高能聚焦超声技术的发展,高温热凝固疗法发展迅速,已成为一种临床实用的肿瘤治疗手段。Tumor hyperthermia refers to the use of a certain heating method to heat the tumor tissue to a temperature higher than its heat-resistant temperature to kill cancer cells. It includes hyperthermia and high-temperature thermal coagulation. Hyperthermia is to heat the tumor to 42.5～45℃ and keep it for a certain period of time (usually several minutes to tens of minutes) to inhibit the growth of tumor tissue to achieve the purpose of treating cancer. High-temperature thermal coagulation method is to heat the tumor tissue to a higher temperature (usually 60 ℃ immediately, or 54 ℃ for one minute) to complete the tumor necrosis. In recent years, with the development of microwave technology, especially implantable microwave technology, radio frequency technology and high-energy focused ultrasound technology, high temperature thermal coagulation therapy has developed rapidly and has become a clinically practical tumor treatment method.

一个有效的热疗必须将被治疗组织中的温度分布控制在适宜范围内,因此对组织温度进行准确测控非常重要。目前，临床上多采用的有创测温技术也称侵入式测量。如图1所示，在消融探针11的远端设置有测温传感器12，测温传感器12与消融探针11连接，通过把热电偶、热敏电阻之类的测温传感器12与消融探针11一起放置到肿瘤组织10内(也在肿瘤组织与正常组织的交界区13内)待测部位进行单点或多点的直接测温。An effective hyperthermia must control the temperature distribution in the treated tissue within an appropriate range, so it is very important to accurately measure and control the tissue temperature. At present, the most commonly used clinically invasive temperature measurement technology is also called invasive measurement. As shown in Figure 1, atemperature sensor 12 is provided at the distal end of theablation probe 11. Thetemperature sensor 12 is connected to theablation probe 11. Theneedle 11 is placed together in the tumor tissue 10 (also in theboundary area 13 between the tumor tissue and the normal tissue) to perform direct temperature measurement at a single point or multiple points.

另一方面，该消融探针也能作为冷冻探针，通过冷却气体实现冷冻消融。冷冻消融是指使癌组织快速冷冻至特定温度(例如，－60℃)以下，然后复温，从而导致癌细胞脱水破裂，或者导致肿瘤小血管缺氧，从而导致癌细胞死亡。进行冷冻消融术后，病变部位的死亡肿瘤组织将作为抗原，促进机体发生抗肿瘤免疫反应。由于冷冻后的癌细胞对化疗或放疗的敏感程度较大，所以化疗或放疗对其的治疗效果增强。同样，现有冷冻消融针消融过程中也存在温度检测不准确的问题，此时，如果仍按照原规划的消融条件进行消融，将可能导致不完全消融或过度消融的问题。On the other hand, the ablation probe can also be used as a cryoprobe to realize cryoablation by cooling gas. Cryoablation refers to the rapid freezing of cancer tissues to a temperature below a specific temperature (for example, -60°C) and then rewarming, which can cause the cancer cells to rupture and dehydration, or cause the tumor's small blood vessels to become hypoxic, leading to the death of cancer cells. After cryoablation, the dead tumor tissue at the diseased site will act as an antigen to promote the body's anti-tumor immune response. Since frozen cancer cells are more sensitive to chemotherapy or radiotherapy, the therapeutic effect of chemotherapy or radiotherapy is enhanced. Similarly, the existing cryoablation needles also have the problem of inaccurate temperature detection during the ablation process. At this time, if the ablation is still performed according to the originally planned ablation conditions, the problem of incomplete or excessive ablation may be caused.

发明内容Summary of the invention

本发明所要解决的首要技术问题在于提供一种用于图像引导消融术的消融导管。The primary technical problem to be solved by the present invention is to provide an ablation catheter for image-guided ablation.

本发明所要解决的另一技术问题在于提供一种包括上述消融导管的消融设备。Another technical problem to be solved by the present invention is to provide an ablation device including the above-mentioned ablation catheter.

为了实现上述目的，本发明采用下述的技术方案：In order to achieve the above objectives, the present invention adopts the following technical solutions:

根据本发明实施例的第一方面，提供一种用于图像引导消融术的消融导管，包括细长形的导管主体，在导管主体的远端设置有不同的第一导管分支和第二导管分支；在第一导管分支的远端设置有消融探针，在第二导管分支的远端设置有测温探针；在导管主体的近端设置有控制手柄以分别控制所述消融探针和所述测温探针；According to a first aspect of the embodiments of the present invention, there is provided an ablation catheter for image-guided ablation, including an elongated catheter body, and different first catheter branches and second catheter branches are provided at the distal end of the catheter body An ablation probe is provided at the distal end of the first catheter branch, and a temperature probe is provided at the distal end of the second catheter branch; a control handle is provided at the proximal end of the catheter body to control the ablation probe and the The temperature measuring probe;

所述消融探针远端设置有消融电极；所述测温探针远端设置有第一测温传感器。The distal end of the ablation probe is provided with an ablation electrode; the distal end of the temperature probe is provided with a first temperature sensor.

其中较优地，所述第一测温传感器设置在所述测温探针远端，并且，所述第一测温传感器的表面与所述测温探针的表面平齐。Preferably, the first temperature measurement sensor is arranged at the distal end of the temperature measurement probe, and the surface of the first temperature measurement sensor is flush with the surface of the temperature measurement probe.

其中较优地，所述测温探针设置有第一测温传感器；Preferably, the temperature measurement probe is provided with a first temperature measurement sensor;

所述消融探针的近端设置有第二测温传感器和第三测温传感器，所述第二测温传感器设置于冷冻剂进液管路上，并且所述第三测温传感器设置于冷冻剂回流管路。The proximal end of the ablation probe is provided with a second temperature measuring sensor and a third temperature measuring sensor, the second temperature measuring sensor is arranged on the refrigerant inlet pipe, and the third temperature measuring sensor is arranged on the refrigerant Return line.

其中较优地，所述第二测温传感器和所述第三测温传感器位于手术时不会进入人体内的位置。Among them, preferably, the second temperature measurement sensor and the third temperature measurement sensor are located in a position that will not enter the human body during an operation.

其中较优地，还包括注射探针，其与所述消融探针和所述测温探针的远端均相互独立。Preferably, it further includes an injection probe, which is independent of the distal ends of the ablation probe and the temperature measurement probe.

其中较优地，所述注射探针包括电极管体，内置于所述电极管体内的空心引导管，以及冷却液管，Preferably, the injection probe includes an electrode tube body, a hollow guide tube built into the electrode tube body, and a coolant tube,

所述空心引导管用于注射液体，所述冷却液管用于输送冷却剂。The hollow guide tube is used for injecting liquid, and the cooling liquid tube is used for conveying coolant.

其中较优地，所述注射探针还包括设置在所述电极管体远端的测温传感器。Preferably, the injection probe further includes a temperature sensor arranged at the distal end of the electrode tube body.

根据本发明实施例的第二方面，提供一种消融设备，包括上述的消融导管。该消融设备还包括消融主机，所述消融主机通过连接线与所述控制手柄连接；According to a second aspect of the embodiments of the present invention, an ablation device is provided, including the ablation catheter described above. The ablation device also includes an ablation host, and the ablation host is connected to the control handle through a connection line;

所述消融主机包括控制模块、温度监测模块和消融模块，所述控制模块分别与所述温度监测模块和所述消融模块连接；其中，The ablation host includes a control module, a temperature monitoring module, and an ablation module, and the control module is respectively connected to the temperature monitoring module and the ablation module; wherein,

所述消融模块用于控制消融探针的能量；The ablation module is used to control the energy of the ablation probe;

所述温度监测模块用于通过测温探针对交界区外的温度进行实时测量；The temperature monitoring module is used for real-time measurement of the temperature outside the boundary area through a temperature measuring probe;

所述控制模块用于根据所述温度监测模块所采集的实时温度值，对所述消融模块的消融时间和功率进行控制。The control module is used to control the ablation time and power of the ablation module according to the real-time temperature value collected by the temperature monitoring module.

其中较优地，所述消融主机还包括与控制模块连接的阻抗监测模块；所述阻抗监测模块用于获取所述消融探针和所述测温探针之间的组织的阻抗；Preferably, the ablation host further includes an impedance monitoring module connected to the control module; the impedance monitoring module is used to obtain the impedance of the tissue between the ablation probe and the temperature measurement probe;

所述控制模块，用于通过所述阻抗监测模块所获得的阻抗值对待消融组织的消融效果进行评估。The control module is used to evaluate the ablation effect of the tissue to be ablated through the impedance value obtained by the impedance monitoring module.

其中较优地，所述温度监测模块还用于获取所述消融探针的第二温度传感器和第三温度传感器的检测温度；Preferably, the temperature monitoring module is also used to obtain the detected temperatures of the second temperature sensor and the third temperature sensor of the ablation probe;

所述控制模块还用于根据所述检测温度对消融温度进行控制。The control module is also used to control the ablation temperature according to the detected temperature.

在本发明所提供的用于图像引导消融术的消融导管中，消融探针和测温探针在近端同时置于消融导管内，在远端分开独自实现不同的功能，进一步还可以设置独立的具有测温和注射功能的注射探针。在将消融探针放置于待消融组织内消融的同时，可以将测温探针定位于待消融组织与正常组织的交界处，对待消融组织交界区的实际温度进行实时准确地测量，通过上述测温探针对待消融组织的消融过程进行监测，可以准确测量待消融组织交界区的温度，从而精准控制消融手术实施，使待消融组织消融完全、防止待消融组织复发，又可以有效保护正常组织，防止过度消融。其次，使用本发明所提供的用于图像引导消融术的消融导管，能够在消融前将隔离液注入消融区域的四周，保护正常组织，也可以在消融的同时注射辅助药物，提高治疗效果。最后，利用检测进出冷冻剂的温差以检测整个冷却回路的温度损耗，从而保护针道正常组织不受损伤。In the ablation catheter for image-guided ablation provided by the present invention, the ablation probe and the temperature measuring probe are placed in the ablation catheter at the proximal end at the same time, and the distal end is separated to achieve different functions independently, and further independent The injection probe with temperature measurement and injection functions. While placing the ablation probe in the tissue to be ablated, the temperature measuring probe can be positioned at the junction of the tissue to be ablated and the normal tissue, and the actual temperature of the junction area of the tissue to be ablated can be accurately measured in real time. The warm probe monitors the ablation process of the tissue to be ablated, which can accurately measure the temperature of the junction area of the tissue to be ablated, thereby accurately controlling the implementation of the ablation operation, so that the tissue to be ablated is completely ablated, preventing the recurrence of the tissue to be ablated, and can effectively protect normal tissues. Prevent excessive ablation. Secondly, the use of the ablation catheter for image-guided ablation provided by the present invention can inject isolation fluid around the ablation area before ablation to protect normal tissues, and can also inject auxiliary drugs during ablation to improve the treatment effect. Finally, the temperature difference between entering and exiting the refrigerant is used to detect the temperature loss of the entire cooling circuit, so as to protect the normal tissue of the needle track from damage.

附图说明Description of the drawings

图1为现有介入手术中，侵入式测温方式的示意图；Figure 1 is a schematic diagram of an invasive temperature measurement method in an existing interventional operation;

图2为本发明实施例中，交界区的示意图；Figure 2 is a schematic diagram of the junction area in an embodiment of the present invention;

图3为本发明第一实施例所提供的消融导管的测温方式的示意图；3 is a schematic diagram of the temperature measurement method of the ablation catheter provided by the first embodiment of the present invention;

图4为本发明第一实施例所提供的消融设备的结构示意图；4 is a schematic structural diagram of the ablation device provided by the first embodiment of the present invention;

图5为本发明第一实施例所提供的消融主机的模块组成图；5 is a diagram of the module composition of the ablation host provided by the first embodiment of the present invention;

图6为本发明第二实施例所提供的消融导管中，消融探针的结构示意图；6 is a schematic diagram of the structure of the ablation probe in the ablation catheter provided by the second embodiment of the present invention;

图7为本发明第二实施例所提供的消融设备的结构示意图；Fig. 7 is a schematic structural diagram of an ablation device provided by a second embodiment of the present invention;

图8为本发明第二实施例所提供的消融主机的模块组成图；8 is a diagram of the module composition of the ablation host provided by the second embodiment of the present invention;

图9为本发明第三实施例所提供的消融导管的使用方式示意图；9 is a schematic diagram of the use of the ablation catheter provided by the third embodiment of the present invention;

图10为图9中的消融导管的结构示意图；Fig. 10 is a schematic structural diagram of the ablation catheter in Fig. 9;

图11为图9中的消融导管的注射探针的内部结构示意图；11 is a schematic diagram of the internal structure of the injection probe of the ablation catheter in FIG. 9;

图12为本发明第四实施例所提供的消融导管的注射探针及其控制系统的结构示意图；12 is a schematic diagram of the structure of the injection probe of the ablation catheter and its control system provided by the fourth embodiment of the present invention;

图13为本发明第四实施例所提供的消融导管的注射探针的内部结构示意图。13 is a schematic diagram of the internal structure of the injection probe of the ablation catheter provided by the fourth embodiment of the present invention.

具体实施方式Detailed ways

下面结合附图和具体的实施例对本发明的技术方案进行进一步的详细说明。The technical solution of the present invention will be further described in detail below in conjunction with the drawings and specific embodiments.

众所周知，根据活检结果，肿瘤细胞的浸润范围要比CT上的低密度影和MRI上T2加权像的高信号范围更广，因此无法根据影像来准确地判断肿瘤细胞浸润范围，这就造成很多介入手术没有将肿瘤组织及其浸润范围内的组织全部消融，显著降低了肿瘤手术的疗效。As we all know, according to the results of biopsy, the range of tumor cell infiltration is wider than the low-density image on CT and the high signal range of T2-weighted image on MRI. Therefore, it is impossible to accurately determine the range of tumor cell infiltration based on the image, which causes a lot of interventions. The surgery did not completely ablate the tumor tissue and the tissue within the infiltration range, which significantly reduced the efficacy of tumor surgery.

如图2所示CT影像示意图中，待消融组织10(例如肿瘤组织)浸润到待消融组织10边缘外的正常组织中。医生从影像图中可以判断出完全没有肿瘤细胞的正常组织15。在待消融组织10边缘与正常组织(无肿瘤细胞)15之间的部位，即图中箭头所示区域，是交界区13。该交界区13是指从待消融组织10(例如，肿瘤组织)边缘(影像学上看到的边缘)过渡到完全没有肿瘤细胞的肿瘤周边正常组织15的这部分组织，交界区13内有少量肿瘤细胞和大量正常组织。In the schematic diagram of the CT image shown in FIG. 2, thetissue 10 to be ablated (for example, tumor tissue) infiltrates into the normal tissue outside the edge of thetissue 10 to be ablated. The doctor can judge the normal tissue without tumor cells from theimage 15. The area between the edge of thetissue 10 to be ablated and the normal tissue (no tumor cells) 15, that is, the area indicated by the arrow in the figure, is thejunction area 13. Thejunction zone 13 refers to the part of the tissue that transitions from the edge of the tissue to be ablated 10 (for example, tumor tissue) (the edge seen on imaging) to thenormal tissue 15 around the tumor that is completely free of tumor cells. There is a small amount in thejunction zone 13 Tumor cells and a lot of normal tissues.

本发明实施例所提供的消融导管包括独立设置的测温探针，通过将测温探针的测温点(测温探针进入待消融组织的点)18位于待消融组织10和正常组织15的交界区13外部，使其位于正常组织15内靠 近交界区13的位置，改善了消融手术过程中的温度监测效果。The ablation catheter provided by the embodiment of the present invention includes an independently set temperature measuring probe, and the temperature measuring point (the point at which the temperature measuring probe enters the tissue to be ablated) 18 of the temperature measuring probe is located in the tissue to be ablated 10 and thenormal tissue 15 The outside of thejunction area 13 is located in thenormal tissue 15 close to thejunction area 13, which improves the temperature monitoring effect during the ablation operation.

<第一实施例><First Embodiment>

本发明实施例所提供的消融导管和消融设备适用于图像引导下的消融手术。如图3和图4所示，本发明实施例所提供的射频导管，具有独立功能的消融探针20和测温探针21，通过将消融探针20放置于待消融组织10(例如肿瘤)内，并将测温探针21定位于待消融组织10与正常组织15之间的(或者说是肿瘤组织与正常组织的)交界区13之外(即，正常组织中邻近待消融组织10的位置)，对待消融组织10交界区的实际温度进行实时准确地测量，从而可以精确控制消融手术实施，使待消融组织消融完全、防止待消融组织复发，又可以有效保护正常组织，防止过度消融。The ablation catheter and ablation equipment provided by the embodiments of the present invention are suitable for image-guided ablation surgery. As shown in FIGS. 3 and 4, the radio frequency catheter provided by the embodiment of the present invention has anablation probe 20 and atemperature measuring probe 21 with independent functions. Theablation probe 20 is placed on the tissue 10 (such as a tumor) to be ablated Thetemperature measuring probe 21 is positioned outside theboundary zone 13 between the tissue to be ablated 10 and the normal tissue 15 (or the tumor tissue and the normal tissue) (that is, the normal tissue adjacent to the tissue to be ablated 10). Position), the actual temperature of the boundary area of the tissue to be ablated 10 can be accurately measured in real time, so that the implementation of the ablation operation can be accurately controlled, the tissue to be ablated can be completely ablated, the recurrence of the tissue to be ablated can be prevented, and the normal tissue can be effectively protected and excessive ablation can be prevented.

具体来说，如图4所示，本发明实施例所提供的射频导管，包括细长型的导管主体24，在导管主体24的远端还设置有不同的第一分支导管25和第二分支导管26。在第一分支导管25的远端设置有消融探针20，消融探针20硬度较高，远端设置为针尖型，便于刺入待消融组织10，消融探针20可以采用医用穿刺针的材质制造，例如不锈钢。在第二消融导管26的远端设置有测温探针21，测温探针21硬度较高，测温探针21远端设置为针尖型，测温探针21能够独立刺入待消融组织10和正常组织15的交界区13之外的位置。测温探针21同样可以采用医用穿刺针的材质制造，例如不锈钢。第一分支导管25和第二分支导管26相对于导管主体24长度较短、质地较软，弯曲度更高，便于握持消融探针20和测温探针21实现穿刺操作。Specifically, as shown in FIG. 4, the radio frequency catheter provided by the embodiment of the present invention includes anelongated catheter body 24, and differentfirst branch catheters 25 and second branches are provided at the distal end of thecatheter body 24.Conduit 26. Anablation probe 20 is provided at the distal end of thefirst branch catheter 25. Theablation probe 20 has a relatively high hardness, and the distal end is a needle tip type to facilitate penetration of thetissue 10 to be ablated. Theablation probe 20 can be made of a medical puncture needle. Manufacturing, such as stainless steel. Atemperature measuring probe 21 is provided at the distal end of thesecond ablation catheter 26. Thetemperature measuring probe 21 has a relatively high hardness. The distal end of thetemperature measuring probe 21 is set in a needle tip type. 10 and thenormal tissue 15 outside theboundary area 13. Thetemperature measuring probe 21 can also be made of the material of a medical puncture needle, such as stainless steel. Thefirst branch catheter 25 and thesecond branch catheter 26 have a shorter length, a softer texture, and a higher degree of curvature relative to the cathetermain body 24, making it easy to hold theablation probe 20 and thetemperature measuring probe 21 for puncture operations.

在导管主体24的近端设置有控制手柄27。在导管主体24的内部设置有平行的第一导线和第二导线。第一导线的远端从第一分支导管25内部穿过，并与消融探针20的近端连接；第一导线的近端连接到控制手柄27。第二导线的远端从第二分支导管26内部穿过，并与测温探针21的近端连接；第二导线的近端连接到控制手柄27。A control handle 27 is provided at the proximal end of the cathetermain body 24. A first wire and a second wire in parallel are provided inside the cathetermain body 24. The distal end of the first wire passes through the inside of thefirst branch catheter 25 and is connected to the proximal end of theablation probe 20; the proximal end of the first wire is connected to the control handle 27. The distal end of the second wire passes through the inside of thesecond branch catheter 26 and is connected to the proximal end of thetemperature measuring probe 21; the proximal end of the second wire is connected to the control handle 27.

射频探针20包括空心的穿刺针，在穿刺针的远端(也可以是靠近病灶的一端)设置有消融电极23，第一导线的远端穿入穿刺针的内部并与消融电极23连接，用于向消融电极23传输能量。较优地，消融电极23嵌入穿刺针的内部，消融电极23的表面与穿刺针平齐，便于 穿刺操作。Theradio frequency probe 20 includes a hollow puncture needle. The distal end of the puncture needle (or the end close to the lesion) is provided with anablation electrode 23. The distal end of the first wire penetrates into the puncture needle and is connected to theablation electrode 23, It is used to transmit energy to theablation electrode 23. Preferably, theablation electrode 23 is embedded in the puncture needle, and the surface of theablation electrode 23 is flush with the puncture needle, which facilitates the puncture operation.

测温探针21包括空心的穿刺针，并在穿刺针的远端(也可以是靠近病灶的一端)设置有第一测温传感器22(例如，热电偶、热敏电阻，等)，第二导线的远端穿入穿刺针的内部并与第一测温传感器22连接。较优地，第一测温传感器22嵌入穿刺针的内部，第一测温传感器22的表面与穿刺针平齐，便于穿刺操作。Thetemperature measuring probe 21 includes a hollow puncture needle, and a first temperature measuring sensor 22 (for example, a thermocouple, thermistor, etc.) is arranged at the distal end of the puncture needle (or the end close to the lesion), and the second The distal end of the wire penetrates the inside of the puncture needle and is connected with thefirst temperature sensor 22. Preferably, the firsttemperature measurement sensor 22 is embedded in the puncture needle, and the surface of the firsttemperature measurement sensor 22 is flush with the puncture needle, which facilitates the puncture operation.

通过第一测温传感器22和消融电极23组成回路，可以在消融之前对消融探针20和测温探针21之间的待消融组织10的阻抗进行测量，得到第一阻抗。在消融完毕之后，通过再次测量待消融组织的阻抗，得到第二阻抗。将第一阻抗与第二阻抗进行比较，以评估消融效果。By forming a loop of thefirst temperature sensor 22 and theablation electrode 23, the impedance of thetissue 10 to be ablated between theablation probe 20 and thetemperature probe 21 can be measured before ablation to obtain the first impedance. After the ablation is completed, the second impedance is obtained by measuring the impedance of the tissue to be ablated again. The first impedance is compared with the second impedance to evaluate the ablation effect.

较优地，图像引导消融治疗手术过程中，医生通过观察影像，使测温探针21中第一测温传感器22的测量位置控制在距离待消融组织10与正常组织15的交界区13之外(即，图2中靠近无肿瘤细胞的正常组织的一侧)2～10mm的范围内。具体到每个肿瘤需要消融覆盖多少肿瘤边缘之外的交界区的组织，需要医生根据肿瘤情况来确定，因此，第一测温传感器22的测量位置在交界区外2～10mm的范围内由医生选定。本领域普通技术人员可以理解，前述范围可以根据病情调整，并不构成对本发明保护范围的限制。Preferably, during the image-guided ablation treatment operation, the doctor controls the measurement position of the firsttemperature measurement sensor 22 in thetemperature measurement probe 21 to be outside theboundary 13 between the tissue to be ablated 10 and thenormal tissue 15 by observing the image. (That is, the side close to the normal tissue without tumor cells in Fig. 2) is within the range of 2-10 mm. Specifically, how much tissue in the junction area outside the tumor edge needs to be ablated for each tumor, which needs to be determined by the doctor according to the tumor situation. Therefore, the measurement position of thefirst temperature sensor 22 is within 2-10 mm outside the junction area by the doctor. Selected. Those of ordinary skill in the art can understand that the foregoing range can be adjusted according to the condition of the disease, and does not constitute a limitation on the protection scope of the present invention.

更优的是，第一测温传感器22的测量位置在，交界区13中距离消融电极23最远的位置的外侧(远离消融电极13的一侧)。这样的第一测温传感器22位置，可以实现从消融电极23到第一测温传感器22的距离，大于消融电极23到待消融组织(肿瘤组织)10的交界区上任意一点的距离，也大于消融电极23到交界区13的任意一点的距离，因此第一测温传感器22的温度，低于待消融组织(肿瘤组织)10的交界区上任意一点的温度，也低于交界区13的任意一点的温度。所以，只要保证第一测温传感器22的温度高于杀灭肿瘤细胞的预设温度(例如60度)，整个待消融组织(肿瘤组织)10及交界区13的温度，都会高于预设温度，从而达到将整个待消融组织(肿瘤组织)10及交界区13的细胞都杀灭的效果。More preferably, the measurement position of the firsttemperature measuring sensor 22 is outside the position farthest from theablation electrode 23 in the junction area 13 (the side far from the ablation electrode 13). Such a position of the firsttemperature measurement sensor 22 can realize the distance from theablation electrode 23 to the firsttemperature measurement sensor 22, which is greater than the distance between theablation electrode 23 and any point on the boundary area of the tissue (tumor tissue) 10 to be ablated, and also greater than The distance between theablation electrode 23 and any point of theboundary zone 13, so the temperature of the firsttemperature measuring sensor 22 is lower than the temperature of any point on the boundary zone of the tissue to be ablated (tumor tissue) 10, and also lower than any point in the boundary zone 13 A little temperature. Therefore, as long as it is ensured that the temperature of the firsttemperature measuring sensor 22 is higher than the preset temperature for killing tumor cells (for example, 60 degrees), the temperature of the entire tissue to be ablated (tumor tissue) 10 and thejunction area 13 will be higher than the preset temperature , So as to achieve the effect of killing the cells in the entire tissue to be ablated (tumor tissue) 10 and thejunction area 13.

控制手柄27上设置有多个接头，用于实现消融探针20、测温探针21与消融主机30的连接。A plurality of joints are provided on the control handle 27 to realize the connection of theablation probe 20, thetemperature measurement probe 21 and theablation host 30.

使用上述消融导管进行消融时，通过将消融探针20放置于待消融组织10(例如肿瘤)内，并将测温探针21定位于待消融组织10与正常组织15的交界区之外，靠近交界区13的位置，可以对待消融组织10交界区的实际温度进行实时准确地测量。其中，测温探针21测量的部位为待消融组织10的交界区，由于消融探针20的穿刺消融部位通常为待消融组织10的中心位置，通过对其一侧交界区外部(远离肿瘤组织的外部)的温度进行测量，可以据此精确控制消融手术实施，使待消融组织消融完全、防止待消融组织复发，又可以有效保护正常组织，防止过度消融。When the ablation catheter is used for ablation, theablation probe 20 is placed in the tissue to be ablated 10 (for example, a tumor), and thetemperature measuring probe 21 is positioned outside the boundary area between the tissue to be ablated 10 and thenormal tissue 15, close to The location of thejunction area 13 can be accurately measured in real time with the actual temperature of the junction area of thetissue 10 to be ablated. Wherein, the location measured by thetemperature measuring probe 21 is the junction area of thetissue 10 to be ablated. Since the puncture and ablation location of theablation probe 20 is usually the center of the tissue to be ablated 10, it passes outside the junction area on one side (away from the tumor tissue). Measurement of the temperature outside) can accurately control the implementation of the ablation operation based on this, so that the tissue to be ablated can be completely ablated, prevent the recurrence of the tissue to be ablated, and can effectively protect normal tissues and prevent excessive ablation.

此外，通过将测温探针21和消融探针20独立设置，可以将测温探针21设置在待消融组织10边缘的正常组织内，一方面，可以对待消融组织交界区的温度进行实时测量；另一方面，测温探针21不直接与待消融组织10接触，防止肿瘤组织的扩散种植。In addition, by arranging thetemperature measuring probe 21 and theablation probe 20 independently, thetemperature measuring probe 21 can be set in the normal tissue at the edge of thetissue 10 to be ablated. On the one hand, the temperature of the boundary area of the tissue to be ablated can be measured in real time. On the other hand, thetemperature measuring probe 21 does not directly contact thetissue 10 to be ablated, preventing the spread of tumor tissue.

如图4和图5所示，本发明实施例所提供的消融设备，除去包括上述消融导管外，还包括消融主机30和连接线31，连接线31用于将消融主机30和控制手柄27连接起来。连接线31的一端分别通过第一导线和第二导线与消融探针20和测温探针21相连；连接线31的另一端分别与消融主机30中的消融模块33、温度监测模块34和阻抗测量模块35相连。As shown in Figures 4 and 5, the ablation device provided by the embodiment of the present invention, in addition to including the above-mentioned ablation catheter, also includes anablation host 30 and a connecting line 31. The connecting line 31 is used to connect theablation host 30 and the control handle 27 stand up. One end of the connecting wire 31 is respectively connected to theablation probe 20 and thetemperature measuring probe 21 through the first wire and the second wire; the other end of the connecting wire 31 is respectively connected to theablation module 33, thetemperature monitoring module 34 and the impedance in theablation host 30 Themeasurement module 35 is connected.

如图5所示，消融主机30包括控制模块32、消融模块33、温度监测模块34和阻抗测量模块35；控制模块32分别与温度监测模块33、消融模块34和阻抗测量模块35连接。其中，消融电极23与消融模块33连接，第一测温传感器22与温度监测模块34连接；并且，消融电极23和第一测温传感器22可以同时与阻抗测量模块35连接。As shown in FIG. 5, theablation host 30 includes acontrol module 32, anablation module 33, atemperature monitoring module 34, and animpedance measurement module 35; thecontrol module 32 is connected to thetemperature monitoring module 33, theablation module 34, and theimpedance measurement module 35, respectively. Theablation electrode 23 is connected to theablation module 33, and the firsttemperature measurement sensor 22 is connected to thetemperature monitoring module 34; and theablation electrode 23 and the firsttemperature measurement sensor 22 can be connected to theimpedance measurement module 35 at the same time.

较优地，连接线31是一根由多根导线集成的导线，通过将连接线31的两端分别插入控制手柄27和消融主机30的对应位置，可以实现消融主机30和消融导管的连接。Preferably, the connecting wire 31 is a wire integrated by multiple wires. By inserting the two ends of the connecting wire 31 into the corresponding positions of the control handle 27 and the ablationmain body 30 respectively, the connection between the ablationmain body 30 and the ablation catheter can be realized.

消融模块33用于控制消融电极23向待消融组织10传递射频能量。温度监测模块34用于通过第一测温传感器22测量待消融组织10和正常组织15的交界区13的温度。阻抗监测模块35用于获取消融探针20和测温探针21之间的组织的阻抗，从而对待消融组织的消融效果 进行评估。Theablation module 33 is used to control theablation electrode 23 to transfer radio frequency energy to thetissue 10 to be ablated. Thetemperature monitoring module 34 is used to measure the temperature of theboundary area 13 between the tissue to be ablated 10 and thenormal tissue 15 through thefirst temperature sensor 22. Theimpedance monitoring module 35 is used to obtain the impedance of the tissue between theablation probe 20 and thetemperature measuring probe 21, so as to evaluate the ablation effect of the tissue to be ablated.

控制模块32用于根据温度监测模块34所采集的实时温度值，对消融模块33的消融时间和功率进行控制，以达到精确消融的目的。其中，当测温探针21周围的温度达到设定阈值(例如，42.5°)，并保持设定时间(例如，1min)后，表明待消融组织包括交界地带的一部分正常组织细胞已经被杀死，即可停止消融。此时，待消融组织10以及周边1～2cm左右的正常组织20被杀灭，从而保证消融手术的效果达到外科切除的目的。同时，控制模块32用于根据阻抗监测模块35监测消融探针20与测温探针21之间的电阻抗变化，可以推测出待消融组织的消融状态。Thecontrol module 32 is configured to control the ablation time and power of theablation module 33 according to the real-time temperature value collected by thetemperature monitoring module 34 to achieve the purpose of precise ablation. Wherein, when the temperature around thetemperature measuring probe 21 reaches a set threshold (for example, 42.5°) and keeps it for a set time (for example, 1 min), it indicates that a part of the normal tissue cells in the tissue to be ablated, including the junction zone, has been killed. To stop the ablation. At this time, the tissue to be ablated 10 and thenormal tissue 20 around 1 to 2 cm around are killed, so as to ensure the effect of the ablation operation to achieve the purpose of surgical resection. At the same time, thecontrol module 32 is used to monitor the electrical impedance change between theablation probe 20 and thetemperature measurement probe 21 according to theimpedance monitoring module 35, so as to infer the ablation state of the tissue to be ablated.

<第二实施例><Second Embodiment>

第二实施例所提供的消融导管和消融设备同样适用于图像引导下的冷冻消融手术。其中，射频导管具有独立的消融探针40和测温探针51，通过将消融探针40刺入待消融组织(例如肿瘤)内，并将测温探针51定位于待消融组织10与正常组织15的(肿瘤组织与正常组织的)交界区13之外，对待消融组织10交界区的实际温度进行实时准确地测量，从而可以精确控制消融手术实施，使待消融组织消融完全、防止待消融组织复发，又可以有效保护正常组织，防止过度消融。The ablation catheter and ablation equipment provided in the second embodiment are also suitable for image-guided cryoablation surgery. Among them, the radio frequency catheter has anindependent ablation probe 40 and atemperature measuring probe 51. Theablation probe 40 is inserted into the tissue to be ablated (such as a tumor), and thetemperature measuring probe 51 is positioned on the tissue to be ablated 10 and normal. Outside of theboundary area 13 of the tissue 15 (tumor tissue and normal tissue), the actual temperature of the boundary area of thetissue 10 to be ablated can be accurately measured in real time, so that the implementation of ablation operations can be precisely controlled, so that the tissue to be ablated can be completely ablated and prevent the ablation Tissue recurrence can effectively protect normal tissues and prevent excessive ablation.

在该实施例中，如图6和图7所示，射频导管包括细长型的导管主体55，在导管主体55的远端设置有柔软的第一分支导管53和第二分支导管54。在第一分支导管53的远端(靠近待消融组织10)设置有消融探针40，消融探针40硬度较高，远端设置为针尖型，便于刺入待消融组织10。在第二消融导管54的远端(靠近待消融组织10)设置有测温探针51，测温探针51硬度较高，测温探针51远端设置为针尖型，测温探针51能够独立刺入待消融组织10和正常组织15的交界区13之外的位置。In this embodiment, as shown in FIGS. 6 and 7, the radio frequency catheter includes anelongated catheter body 55, and a flexiblefirst branch catheter 53 and asecond branch catheter 54 are provided at the distal end of thecatheter body 55. Anablation probe 40 is provided at the distal end of the first branch catheter 53 (near thetissue 10 to be ablated). Theablation probe 40 has a relatively high hardness, and the distal end is set in a needle tip type to facilitate penetration of thetissue 10 to be ablated. Atemperature measuring probe 51 is provided at the distal end of the second ablation catheter 54 (close to thetissue 10 to be ablated). Thetemperature measuring probe 51 has a relatively high hardness. The distal end of thetemperature measuring probe 51 is a needle tip type. It can independently penetrate into a position outside theboundary area 13 between the tissue to be ablated 10 and thenormal tissue 15.

在导管主体55的近端设置有控制手柄56。在导管主体55的内部设置有冷却循环管路，包括连通的冷冻剂进液管路45和冷冻剂回流管路46。冷却循环管路缠绕在柔性的引导管48上，引导管48采用非导电材料，具备一定柔性和硬度，以支撑冷却循环管路的弯曲性能，保证冷却回路的通畅性，防止极限折弯。冷冻剂进液管路45的一端连接 到控制手柄56，另一端从第一分支管路53中延伸到消融探针40内部，并在消融探针40远端形成冷冻剂进液口43；冷冻剂回流管路46的一端连接到控制手柄56，另一端从第一分支管路53中延伸到消融探针40内部，并在消融探针40远端形成冷冻剂回流口44。A control handle 56 is provided at the proximal end of the cathetermain body 55. A cooling circulation pipeline is provided inside the ductmain body 55, including arefrigerant inlet pipeline 45 and arefrigerant return pipeline 46 that are connected. The cooling circulation pipeline is wound on theflexible guide tube 48. Theguide tube 48 is made of a non-conductive material with certain flexibility and hardness to support the bending performance of the cooling circulation pipeline, ensure the smoothness of the cooling circuit, and prevent extreme bending. One end of therefrigerant inlet pipe 45 is connected to the control handle 56, and the other end extends from thefirst branch pipe 53 to the inside of theablation probe 40, and arefrigerant inlet 43 is formed at the distal end of theablation probe 40; One end of theagent return line 46 is connected to the control handle 56, and the other end extends from thefirst branch line 53 to the inside of theablation probe 40, and arefrigerant return port 44 is formed at the distal end of theablation probe 40.

在导管主体55的内部设置有多条平行的导线。其中，第一导线的远端从第一分支导管53内部穿过，并与设置在消融探针40的消融探针管体47中的第二测温传感器41连接；第一导线的近端连接到控制手柄56。第三导线的远端从第一分支导管53内部穿过，并与设置在消融探针40中的第三测温传感器42连接；第三导线的近端连接到控制手柄56。第二测温传感器41设置于冷冻剂进液管路45的近端，用于测量流向冷冻剂进液口43的冷冻剂的温度；第三测温传感器42设置于冷冻剂回流管路46的近端，用于测量回流的冷冻剂的温度。换言之，第二测温传感器设置于与流向消融探针的远端的冷冻剂接近的位置，第三测温传感器设置于与回流的冷冻剂接近的位置。用于测量冷冻剂的进液温度和回流温度的第二测温传感器41和第三测温传感器42位于近端，在即使手术时也不会进入人体内的位置(例如位于第一分支导管53与消融探针40连接处)，这样可以减小消融探针40的远端管径，减小消融探针40远端刺入体内造成的创口。A plurality of parallel wires are provided inside the cathetermain body 55. Wherein, the distal end of the first wire passes through the inside of thefirst branch catheter 53 and is connected to thesecond temperature sensor 41 provided in the ablation probe body 47 of theablation probe 40; the proximal end of the first wire is connected To the control handle 56. The distal end of the third wire passes through the inside of thefirst branch catheter 53 and is connected to thethird temperature sensor 42 provided in theablation probe 40; the proximal end of the third wire is connected to the control handle 56. Thesecond temperature sensor 41 is arranged at the proximal end of therefrigerant inlet pipe 45 and is used to measure the temperature of the refrigerant flowing to therefrigerant inlet 43; thethird temperature sensor 42 is arranged at the end of therefrigerant return pipe 46 The proximal end is used to measure the temperature of the refluxing refrigerant. In other words, the second temperature measuring sensor is arranged at a position close to the refrigerant flowing to the distal end of the ablation probe, and the third temperature measuring sensor is arranged at a position close to the refluxing refrigerant. The secondtemperature measurement sensor 41 and the thirdtemperature measurement sensor 42 used to measure the inlet temperature and return temperature of the refrigerant are located at the proximal end, where they will not enter the human body even during surgery (for example, located in the first branch duct 53). It is connected with the ablation probe 40), so that the diameter of the distal end of theablation probe 40 can be reduced, and the wound caused by the distal end of theablation probe 40 piercing into the body can be reduced.

第二导线的远端从第二分支导管54内部穿过，并与设置在测温探针51中的第一测温传感器52连接；第二导线的近端连接到控制手柄56。第一测温传感器52用于测量待消融组织10和正常组织15的交界处13外的温度。第一测温传感器52的使用方式和作用与第一实施例中第一测温传感器22的使用方式和作用相同。在此不再赘述。The distal end of the second wire passes through the inside of thesecond branch catheter 54 and is connected to the firsttemperature measuring sensor 52 provided in thetemperature measuring probe 51; the proximal end of the second wire is connected to the control handle 56. Thefirst temperature sensor 52 is used to measure the temperature outside thejunction 13 between thetissue 10 to be ablated and thenormal tissue 15. The use mode and function of the firsttemperature measurement sensor 52 are the same as the use mode and function of the firsttemperature measurement sensor 22 in the first embodiment. I won't repeat them here.

控制手柄56上设置有多个接头，用于实现消融探针40、测温探针51与消融主机60的连接。Multiple joints are provided on the control handle 56 for connecting theablation probe 40, thetemperature measurement probe 51 and theablation host 60.

使用上述消融导管进行消融时，通过将消融探针40送入待消融组织10(例如肿瘤)内，并将测温探针51定位于待消融组织10与正常组织15的交界区之外，靠近交界区13的位置，可以对待消融组织10交界区的实际温度进行实时准确地测量。其中，测温探针51测量的部位为待消融组织10的交界区外侧(靠近无肿瘤细胞的正常组织)，由于消融探针40的穿刺消融部位通常为待消融组织10的中心位置，通 过对其一侧交界区外部(远离肿瘤组织的外部)的温度进行测量，可以据此判断整个交界区内的温度均达到预期温度，从而精确控制冷冻消融范围，使待消融组织及交界区内的组织被完全消融、防止复发，又可以有效保护正常组织，避免过度消融。When the ablation catheter is used for ablation, theablation probe 40 is fed into the tissue to be ablated 10 (for example, a tumor), and thetemperature measuring probe 51 is positioned outside the boundary area between the tissue to be ablated 10 and thenormal tissue 15, close to The location of thejunction area 13 can be accurately measured in real time with the actual temperature of the junction area of thetissue 10 to be ablated. Wherein, the part measured by thetemperature measuring probe 51 is the outer side of the boundary area of thetissue 10 to be ablated (near normal tissue without tumor cells). Since the puncture and ablation part of theablation probe 40 is usually the center of thetissue 10 to be ablated, The temperature outside the border area on one side (outside the tumor tissue) is measured. Based on this, it can be judged that the temperature in the entire border area has reached the expected temperature, so as to precisely control the cryoablation range, so that the tissue to be ablated and the tissue in the border area can be accurately controlled. Being completely ablated to prevent recurrence, it can effectively protect normal tissues and avoid excessive ablation.

此外，通过将测温探针51和消融探针40独立设置，可以将测温探针51设置在待消融组织10边缘的正常组织内，一方面，可以对待消融组织交界区13的温度进行实时测量；另一方面，测温探针51不直接与待消融组织10接触，防止待消融组织沿针道播散。In addition, by arranging thetemperature measuring probe 51 and theablation probe 40 independently, thetemperature measuring probe 51 can be set in the normal tissue at the edge of thetissue 10 to be ablated. Measurement; on the other hand, thetemperature measuring probe 51 does not directly contact thetissue 10 to be ablated, preventing the tissue to be ablated from spreading along the needle path.

如图7和图8所示，本发明实施例所提供的消融设备，除去包括上述消融导管外，还包括消融主机60和连接线61，连接线61用于将消融主机60和控制手柄56连接起来。连接线61的一端分别通过不同的导线与消融探针40和测温探针51中的测温传感器相连；连接线61的另一端与消融主机60中的温度监测模块64相连。此外，连接线61还包括两条冷冻剂连接管路，两条冷冻剂连接管路分别与冷冻剂进液管路和冷冻剂回流管路对应接通，形成冷冻剂循环管路。其中，在与冷冻剂进液管路45连通的冷冻剂连接管路的末端连接有冷冻剂储存瓶67，用于提供冷冻剂；较优地，在与冷冻剂回流管路46连通的冷冻剂连接管路的末端连接有另一个冷冻剂储存瓶，用于储存经过循环的冷冻剂。在冷冻剂循环管路上设置有控制阀66。As shown in Figures 7 and 8, the ablation device provided by the embodiment of the present invention, in addition to the above-mentioned ablation catheter, also includes anablation host 60 and a connectingline 61. The connectingline 61 is used to connect theablation host 60 and the control handle 56 stand up. One end of the connectingwire 61 is respectively connected to theablation probe 40 and the temperature measuring sensor in thetemperature measuring probe 51 through different wires; the other end of the connectingwire 61 is connected to thetemperature monitoring module 64 in theablation host 60. In addition, theconnection line 61 also includes two refrigerant connection pipelines, and the two refrigerant connection pipelines are respectively connected with the refrigerant inlet pipeline and the refrigerant return pipeline to form a refrigerant circulation pipeline. Among them, arefrigerant storage bottle 67 is connected to the end of the refrigerant connection pipe connected to therefrigerant inlet pipe 45 for providing refrigerant; preferably, therefrigerant storage bottle 67 is connected to therefrigerant return pipe 46. Another refrigerant storage bottle is connected to the end of the connecting pipe for storing the circulating refrigerant. Acontrol valve 66 is provided on the refrigerant circulation line.

消融主机60包括控制模块62、消融模块63、温度监测模块64。控制模块62分别与温度监测模块63、消融模块64连接。其中，冷冻液循环管路上的控制阀66与消融模块63连接，第一测温传感器52、第二测温传感器41、第三测温传感器42分别与温度监测模块64连接。Theablation host 60 includes acontrol module 62, anablation module 63, and atemperature monitoring module 64. Thecontrol module 62 is connected to thetemperature monitoring module 63 and theablation module 64 respectively. Wherein, thecontrol valve 66 on the refrigerant circulation pipeline is connected to theablation module 63, and the firsttemperature measurement sensor 52, the secondtemperature measurement sensor 41, and the thirdtemperature measurement sensor 42 are respectively connected to thetemperature monitoring module 64.

较优地，连接线61是一根由多根导线和多根冷冻剂连接管路集成的连接线，通过将连接线61的两端分别插入控制手柄56和消融主机60的对应位置，可以实现消融主机60和消融导管的连接。Preferably, the connectingwire 61 is a connecting wire integrated by multiple wires and multiple refrigerant connection pipes. By inserting the two ends of the connectingwire 61 into the corresponding positions of the control handle 56 and theablation host 60, ablation can be achieved. Connection of thehost 60 and the ablation catheter.

消融模块63用于控制消融探针40向待消融组织10传递冷冻能量。温度监测模块64用于通过第一测温传感器52测量待消融组织10和正常组织15的交界区16的温度，并通过第二测温传感器41测量冷冻剂进液温度，通过第三测温传感器42测量冷冻剂回流温度。Theablation module 63 is used to control theablation probe 40 to transfer freezing energy to thetissue 10 to be ablated. Thetemperature monitoring module 64 is used to measure the temperature of the boundary area 16 between the tissue to be ablated 10 and thenormal tissue 15 through thefirst temperature sensor 52, and to measure the refrigerant inlet temperature through thesecond temperature sensor 41, and through thethird temperature sensor 42 Measure the reflux temperature of the refrigerant.

控制模块62用于根据温度监测模块64所采集的实时温度值，对 消融模块63的消融时间和功率进行控制，以达到精确消融的目的。其中，当测温探针51周围的温度达到设定阈值(例如，－60°)，并保持设定时间后，表明待消融组织包括交界区的一部分正常组织细胞已经被杀死，即可停止消融。此时，待消融组织10以及周边2mm左右的正常组织20(发生肿瘤浸润的区域)均被杀灭，从而保证消融手术的效果达到外科切除的目的。Thecontrol module 62 is configured to control the ablation time and power of theablation module 63 according to the real-time temperature value collected by thetemperature monitoring module 64 to achieve the purpose of precise ablation. Wherein, when the temperature around thetemperature measuring probe 51 reaches a set threshold (for example, -60°) and keeps it for a set time, it indicates that a part of the normal tissue cells of the tissue to be ablated, including the junction area, has been killed, and it can be stopped. Ablation. At this time, thetissue 10 to be ablated and the normal tissue 20 (the area where tumor infiltration occurs) about 2 mm around are all killed, so as to ensure the effect of the ablation operation to achieve the purpose of surgical resection.

相对于应用冷冻消融的过程中，控制模块62用于根据第一测温传感器52所测得的待消融组织交界区的温度(低于－40度，更优的是零下42度至零下50度)，对待消融组织的实际消融情况进行监测；控制模块62还用于根据第二测温传感器41和第三测温传感器42所测得的冷冻剂进液温度和冷冻剂回流温度之间的差值，控制待消融组织的消融效果。具体而言，根据第二测温传感器41和第三测温传感器42所测得的冷冻剂进液温度和冷冻剂回流温度之间的差值，结合冷冻剂的流速和管径等信息，可以计算出这些冷冻剂在待消融组织体内传导的热量。再根据热量，结合影像学上看到的待消融组织和交界区的体积，可以估算出待消融组织受热情况(例如，消融针头部的温度)，因此可以判断出消融效果。Compared with the process of applying cryoablation, thecontrol module 62 is used to measure the temperature of the junction area of the tissue to be ablated measured by the first temperature sensor 52 (below -40 degrees, preferably minus 42 degrees to minus 50 degrees) ), the actual ablation of the tissue to be ablated is monitored; thecontrol module 62 is also used to determine the difference between the refrigerant inlet temperature and the refrigerant return temperature measured by thesecond temperature sensor 41 and thethird temperature sensor 42 Value, which controls the ablation effect of the tissue to be ablated. Specifically, according to the difference between the refrigerant inlet temperature and the refrigerant reflux temperature measured by thesecond temperature sensor 41 and thethird temperature sensor 42, combined with the refrigerant flow rate and pipe diameter, it can be Calculate the heat conducted by these cryogens in the tissue to be ablated. Based on the heat, combined with the volume of the tissue to be ablated and the junction area seen on imaging, the heating of the tissue to be ablated (for example, the temperature of the ablation needle head) can be estimated, so the ablation effect can be judged.

<第三实施例><Third Embodiment>

如图9～图10所示，本实施例所提供的独立注射探针80，仍然与消融主机关联，可以增加注射隔离液或辅助药物，也可以测温，同时具备循环冷却功能。本实施例的消融导管在第一实施例或第二实施例的基础上还增加了第三分支导管50及设置在第三分支管50的远端的注射探针80。在此只介绍本实施例中与第一实施例不同的部分。本领域普通技术人员可以理解出，相应的，本实施例与第二实施例不同的部分，故此不赘述。As shown in Figs. 9-10, theindependent injection probe 80 provided in this embodiment is still associated with the ablation host, and can add injection spacers or auxiliary drugs, can also measure temperature, and have a circulating cooling function. The ablation catheter of this embodiment adds athird branch catheter 50 and aninjection probe 80 arranged at the distal end of thethird branch pipe 50 on the basis of the first or second embodiment. Only the parts of this embodiment that are different from the first embodiment are introduced here. A person of ordinary skill in the art can understand that, correspondingly, the parts of this embodiment are different from the second embodiment, so they will not be repeated here.

第三分支管50与第一分支管53、第二分支导管54均被容纳在导管主体55A内，并且第三分支管50的一部分从导管主体55A的远端露出，以使注射探针80能刺入体内。第三分支管50与控制手柄56A连接，并且进一步与消融主机60A及冷冻剂储存瓶67A连接。Thethird branch tube 50, thefirst branch tube 53, and thesecond branch tube 54 are all accommodated in thecatheter body 55A, and a part of thethird branch tube 50 is exposed from the distal end of thecatheter body 55A so that theinjection probe 80 can Stabbed into the body. Thethird branch tube 50 is connected to the control handle 56A, and is further connected to theablation host 60A and therefrigerant storage bottle 67A.

本实施例的控制手柄56A上设置有液体注入口68A，其在控制手柄56A的控制下允许注入液体或禁止注入液体。在此，液体可以是隔 离液或辅助药物，或者两者兼有(此时需要有独立的两个管道，用于分别输入隔离液或辅助药物)。在本实施例中以隔离液为例进行说明，但并不构成对本发明保护范围的限制。The control handle 56A of this embodiment is provided with aliquid injection port 68A, which allows or prohibits liquid injection under the control of the control handle 56A. Here, the liquid can be a spacer fluid or an auxiliary medicine, or both (in this case, two separate pipelines are required to input the spacer fluid or auxiliary medicine respectively). In this embodiment, the spacer liquid is taken as an example for description, but it does not constitute a limitation to the protection scope of the present invention.

在图9中，图像引导消融治疗手术过程中，医生通过观察影像，将消融电极23刺入待消融组织10内，可用测温探针21中第一测温传感器22的测量位置控制在待消融组织10与正常组织15的交界区13之外(即，图9中正常组织的靠近消融中心区的一侧)，例如在与交界区13距离5mm的范围内。然后，将注射探针80刺入正常组织15内，并且注入隔离液7，以使射频消融的热量被限制在待消融组织10和交界区13内，以保护正常组织15。由于三针独立，即独立的消融探针20、测温探针21和注射探针80，所以医生可以根据需要，从测温探针21和注射探针80中选择一个使用，也可将三针分别放置到组织内不同的位置(使疗效最佳的位置)，因此可以有效地控制消融时间和功率，达到最佳疗效的同时保护正常组织，而且方便操作。In FIG. 9, during the image-guided ablation treatment operation, the doctor observes the image and pierces theablation electrode 23 into thetissue 10 to be ablated. The measurement position of thefirst temperature sensor 22 in thetemperature probe 21 can be used to control the position to be ablated. Outside theboundary zone 13 between thetissue 10 and the normal tissue 15 (that is, the side of the normal tissue close to the ablation center in FIG. 9 ), for example, within a range of 5 mm from theboundary zone 13. Then, theinjection probe 80 is pierced into thenormal tissue 15 and theisolation liquid 7 is injected, so that the heat of radiofrequency ablation is limited to the tissue to be ablated 10 and thejunction area 13 to protect thenormal tissue 15. Since the three needles are independent, that is,independent ablation probe 20,temperature measurement probe 21 andinjection probe 80, the doctor can choose one of thetemperature measurement probe 21 andinjection probe 80 to use, or use the three The needles are placed in different positions in the tissue (the position for the best curative effect), so the ablation time and power can be effectively controlled, and the best curative effect can be achieved while protecting normal tissues and convenient operation.

如图11所示，注射探针80包括柔性的电极管体81，内置于电极管体81内的空心引导管82，缠绕在空心引导管82外周的冷却液管83，以及设置在电极管体81远端的测温传感器84。图中箭头示意性表示了注射探针80送入的液体(本实施例中是隔离液)的流向。由于冷冻剂从冷冻剂储存瓶67A进入，经过多腔道的第三分支管28，进入冷却液管83；然后在靠近注射探针80的电极管体81的远端的位置折返，以经第三分支管28流出。由此，使电极管体81内外形成冷却。As shown in Figure 11, theinjection probe 80 includes a flexibleelectrode tube body 81, ahollow guide tube 82 built into theelectrode tube body 81, acoolant tube 83 wound around the outer circumference of thehollow guide tube 82, and theelectrode tube body 81remote temperature sensor 84. The arrow in the figure schematically shows the flow direction of the liquid (isolating liquid in this embodiment) delivered by theinjection probe 80. Since the refrigerant enters from therefrigerant storage bottle 67A, passes through the third branch pipe 28 of the multi-lumen channel, and enters thecoolant pipe 83; The three branch pipe 28 flows out. As a result, the inside and outside of theelectrode tube body 81 are cooled.

同时，液体(隔离液或药液)从液体注入口68A进入，通过空心引导管82注入电极管体81内部，并且从设置于电极管体81的远端的多个出液孔810流入人体组织内，以进行消融过程中的隔离或者药物释放。At the same time, the liquid (isolating liquid or medicinal solution) enters from theliquid injection port 68A, is injected into theelectrode tube body 81 through thehollow guide tube 82, and flows into the body tissue from the plurality of liquid outlet holes 810 provided at the distal end of theelectrode tube body 81 In order to isolate or release the drug during the ablation process.

此外，由于注射探针80的远端设置有注射探针测温传感器84，使用时其位于正常组织内，并且接近注射探针送入的液体(本实施例中的隔离液7)，所以其感应到的温度是正常组织内的温度，可以反馈到消融主体60A，以调整消融功率或消融时间等。In addition, since the distal end of theinjection probe 80 is provided with an injection probetemperature measuring sensor 84, it is located in the normal tissue during use and is close to the liquid sent by the injection probe (thespacer 7 in this embodiment), so it is The sensed temperature is the temperature in the normal tissue, which can be fed back to theablation body 60A to adjust the ablation power or ablation time.

<第四实施例><Fourth embodiment>

在第三实施例中，注射探针80与第一分支管53、第二分支导管 54均被容纳在导管主体55A内，共同连接到控制手柄56A、消融主机60A以及冷冻剂储存瓶67A。在本实施例中，如图12所示，注射探针80B通过第三分支管50B，连接到独立的控制手柄56B、消融主机60B。因此，本实施例中的注射探针80B可以被独立控制，即与消融电极23和测温探针21所连接的控制手柄、消融主机(未图示)不同。In the third embodiment, theinjection probe 80, thefirst branch tube 53, and thesecond branch tube 54 are all contained in thecatheter body 55A, and are connected to the control handle 56A, theablation host 60A, and therefrigerant storage bottle 67A. In this embodiment, as shown in FIG. 12, theinjection probe 80B is connected to the independent control handle 56B and theablation host 60B through thethird branch tube 50B. Therefore, theinjection probe 80B in this embodiment can be independently controlled, that is, it is different from the control handle and the ablation host (not shown) connected to theablation electrode 23 and thetemperature measurement probe 21.

本实施例的注射探针80B与第一实施例或第二实施例的消融探针及测温探针可以结合使用，以达到与第三实施例中相似的效果。Theinjection probe 80B of this embodiment can be used in combination with the ablation probe and the temperature measuring probe of the first or second embodiment to achieve similar effects as in the third embodiment.

<第五实施例><Fifth Embodiment>

本实施例提供另一种消融探针，不同于图6所示的消融探针。在此仅介绍与图6所示消融探针不同的部分。This embodiment provides another ablation probe, which is different from the ablation probe shown in FIG. 6. Only the parts that are different from the ablation probe shown in FIG. 6 are introduced here.

如图13所示，该消融探针包括消融探针管体47B，容纳在消融探针管体47B内部的消融探针引导管43B，螺旋缠绕在消融探针引导管43B外周的冷冻剂循环管路49B，设置在消融探针管体47B远端的测温传感器44B，以及包覆在消融探针管体47B的近端的绝缘层48B。图中箭头示意性表示了冷冻剂的流向。冷冻剂从冷冻剂循环管路49B的一端进入，注入到消融探针管体47B的远端，然后在消融探针管体47B的远端的位置折返并流出消融探针管体47B。第二测温传感器41B和第三测温传感器42B的位置距离远端足够远，与第二实施例中类似，以致在手术时也不会进入人体，所以不会对人体造成创口。As shown in Figure 13, the ablation probe includes an ablationprobe tube body 47B, an ablationprobe guide tube 43B accommodated in the ablationprobe tube body 47B, and a refrigerant circulation tube spirally wound around the ablationprobe guide tube 43B.Path 49B, atemperature sensor 44B arranged at the distal end of the ablationprobe tube body 47B, and an insulatinglayer 48B covering the proximal end of the ablationprobe tube body 47B. The arrows in the figure schematically indicate the flow direction of the refrigerant. The refrigerant enters from one end of therefrigerant circulation pipeline 49B, is injected into the distal end of the ablationprobe tube body 47B, and then turns back at the distal end of the ablationprobe tube body 47B and flows out of the ablationprobe tube body 47B. The positions of the secondtemperature measuring sensor 41B and the thirdtemperature measuring sensor 42B are far enough away from the distal end, similar to the second embodiment, so that they will not enter the human body during the operation, so it will not cause wounds to the human body.

绝缘层48B是PTFE隔离绝缘层，具有亲水性、高润滑性和耐高温。可以保证消融区域以外的绝缘性能。在消融探针远端设置的测温传感器44B，可直接测量消融病灶的中心温度，通过手术过程中的显示设备上显示的温度和消融时间，结合前期大量离体消融数据，可推算该温度下消融的大致范围。The insulatinglayer 48B is a PTFE isolation insulating layer, which has hydrophilicity, high lubricity and high temperature resistance. The insulation performance outside the ablation area can be guaranteed. Thetemperature measuring sensor 44B installed at the distal end of the ablation probe can directly measure the central temperature of the ablation lesion. The temperature and ablation time displayed on the display device during the operation can be used to calculate the temperature under this temperature and the ablation time. The approximate range of ablation.

在本实施例中的消融探针管体47B的远端，不同于图6中，没有将冷冻剂与消融探针引导管43B隔离开的挡片401(见图6)，所以消融探针引导管43B的远端是浸没在冷冻剂内的，扩大了冷冻剂在消融探针引导管43B远端的容纳空间，进一步提高冷却效果。The distal end of the ablationprobe tube body 47B in this embodiment is different from FIG. The distal end of thetube 43B is immersed in the refrigerant, which enlarges the accommodating space of the refrigerant at the distal end of the ablationprobe guide tube 43B, and further improves the cooling effect.

而且，在本实施例中的消融探针管体47B的远端，还设置有远端测温传感器44B，其位于消融探针管体47B的远端并浸没在冷冻剂内，可以检测到待消融组织10的中心温度。第二测温传感器41B、第三测 温传感器42B、远端测温传感器44B以及注射探针测温传感器84，提供了多处检测到的温度，因此可以反馈控制消融参数，以实现更精确的消融控制。Moreover, the distal end of theablation probe body 47B in this embodiment is also provided with adistal temperature sensor 44B, which is located at the distal end of theablation probe body 47B and is immersed in the refrigerant, and can detect the The core temperature of theablated tissue 10. The secondtemperature measurement sensor 41B, the thirdtemperature measurement sensor 42B, the remotetemperature measurement sensor 44B, and the injection probetemperature measurement sensor 84 provide multiple detected temperatures, so the ablation parameters can be feedback-controlled to achieve more accurate Ablation control.

本实施例中的消融设备适用于图像引导下，对乳腺、肝脏、甲状腺等组织的射频消融手术、冷冻消融手术等。The ablation device in this embodiment is suitable for radiofrequency ablation and cryoablation of breast, liver, thyroid and other tissues under image guidance.

本实施例中的消融探针，其冷却循环管路45采用弹簧形式，可有效增加针头前端的抗折弯性，并且减小消融探针或注射探针的外径。本实施例中，优选采用在远端位置相互分开的消融探针、In the ablation probe in this embodiment, the coolingcircuit 45 adopts a spring form, which can effectively increase the bending resistance of the tip of the needle and reduce the outer diameter of the ablation probe or the injection probe. In this embodiment, it is preferable to use ablation probes that are separated from each other at the distal position,

综上所述，本发明所提供的消融导管和消融设备，包括独立的消融探针和测温探针，以微创的方式，将微小的测温探针设置在需要消融的待消融组织与正常组织的交界区外，消融手术中实时监测该区域的温度变化，精准控制消融手术实施，使待消融组织消融完全、防止待消融组织复发，又可以有效保护正常组织，防止过度消融。In summary, the ablation catheter and ablation equipment provided by the present invention include independent ablation probes and temperature measurement probes. In a minimally invasive manner, the tiny temperature measurement probes are set on the tissue to be ablated and Outside the boundary area of normal tissues, the temperature changes in the area are monitored in real time during ablation operations, and the implementation of ablation operations is accurately controlled to make the tissue to be ablated completely ablate, prevent the recurrence of the tissue to be ablated, and can effectively protect the normal tissue and prevent excessive ablation.

上述消融探针和测温探针独立设计的技术方案，与惯常设计思路不同。惯常设计思路是减少创伤，将二者结合在一起，通过一个创口同时送入消融探针和测温探针。本发明则需要用两个创口分别送入消融探针和测温探针，或者通过一个创口分两次分别送入消融探针和测温探针，但是通过将测温探针设置在需要消融的待消融组织与正常组织的交界区外，在消融手术中实时监测该区域的温度变化，精准控制消融手术实施，达到彻底消融整个肿瘤组织及其浸润的正常组织的效果，避免肿瘤复发。The above-mentioned independent design of the ablation probe and the temperature measurement probe is different from the usual design ideas. The usual design idea is to reduce trauma, combine the two together, and send the ablation probe and the temperature probe through a wound at the same time. In the present invention, the ablation probe and the temperature measuring probe need to be fed into two wounds respectively, or the ablation probe and the temperature measuring probe are fed into the ablation probe and the temperature measuring probe in two times through one wound. Outside the boundary area between the tissue to be ablated and the normal tissue, the temperature change in the area is monitored in real time during the ablation operation, and the implementation of the ablation operation is accurately controlled to achieve the complete ablation of the entire tumor tissue and the normal tissue infiltrated, and avoid tumor recurrence.

其次，使用本发明所提供的用于图像引导消融术的消融导管，在测温探针不易放置的情况下，将注射探针设置在正常组织的靠近交界区的位置，能够在消融前将隔离液注入消融区域的四周，保护正常组织，也可以在消融的同时注射辅助药物，提高治疗效果。而且，位于注射探针远端的测温传感器主要测量隔离液温度，保证隔离区域安全性。最后，利用设置于冷冻剂进液管路的第二测温传感器以及设置在冷冻剂回流管路的第三测温传感器，检测二者的温差能够反映整个冷却回路的温度损耗，以反应整个电极后端的温度，保护针道正常组织不受损伤。Secondly, using the ablation catheter for image-guided ablation provided by the present invention, in the case that the temperature measuring probe is not easy to place, the injection probe is set at a position close to the junction area of the normal tissue, which can isolate before ablation The liquid is injected around the ablation area to protect normal tissues, and auxiliary drugs can also be injected during ablation to improve the treatment effect. Moreover, the temperature sensor located at the far end of the injection probe mainly measures the temperature of the isolation liquid to ensure the safety of the isolation area. Finally, by using the second temperature measuring sensor arranged in the refrigerant inlet pipe and the third temperature measuring sensor arranged in the refrigerant return pipe, detecting the temperature difference between the two can reflect the temperature loss of the entire cooling circuit to reflect the entire electrode The temperature of the rear end protects the normal tissues of the needle track from damage.

以上对本发明所提供的用于图像引导消融术的消融导管和消融设 备进行了详细的说明。并且，上述各个实施例只是为了描述的方便而拆分到不同实施例进行说明，但是各实施例的各个部件之间可以组合成新的设计方案。对本领域的一般技术人员而言，在不背离本发明实质内容的前提下对它所做的任何显而易见的改动，都将构成对本发明专利权的侵犯，将承担相应的法律责任。The ablation catheter and ablation device for image-guided ablation provided by the present invention have been described in detail above. In addition, the above-mentioned various embodiments are split into different embodiments for description only for the convenience of description, but the various components of the various embodiments can be combined into a new design solution. For those of ordinary skill in the art, any obvious changes made to the present invention without departing from the essential content of the present invention will constitute an infringement of the patent right of the present invention and will bear corresponding legal liabilities.

Claims (10)

Translated fromChinese

一种用于图像引导消融术的消融导管，其特征在于包括导管主体，在导管主体的远端设置有不同的第一导管分支和第二导管分支；在第一导管分支的远端设置有消融探针，在第二导管分支的远端设置有测温探针；在导管主体的近端设置有控制手柄以分别控制所述消融探针和所述测温探针，An ablation catheter for image-guided ablation, which is characterized in that it comprises a catheter body. Different first catheter branches and second catheter branches are arranged at the distal end of the catheter body; ablation catheters are arranged at the distal end of the first catheter branch. The probe is provided with a temperature measuring probe at the distal end of the second catheter branch; a control handle is provided at the proximal end of the catheter body to control the ablation probe and the temperature probe respectively,所述消融探针远端设置有消融电极；所述测温探针远端设置有第一测温传感器。The distal end of the ablation probe is provided with an ablation electrode; the distal end of the temperature probe is provided with a first temperature sensor.如权利要求1所述的消融导管，其特征在于：The ablation catheter of claim 1, wherein:所述第一测温传感器设置在所述测温探针远端，并且，所述第一测温传感器的表面与所述测温探针的表面平齐。The first temperature measurement sensor is arranged at the distal end of the temperature measurement probe, and the surface of the first temperature measurement sensor is flush with the surface of the temperature measurement probe.如权利要求1所述的消融导管，其特征在于：The ablation catheter of claim 1, wherein:所述测温探针设置有第一测温传感器；The temperature measuring probe is provided with a first temperature measuring sensor;所述消融探针的近端设置有第二测温传感器和第三测温传感器，所述第二测温传感器设置于冷冻剂进液管路上，并且所述第三测温传感器设置于冷冻剂回流管路。The proximal end of the ablation probe is provided with a second temperature measuring sensor and a third temperature measuring sensor, the second temperature measuring sensor is arranged on the refrigerant inlet pipe, and the third temperature measuring sensor is arranged on the refrigerant Return line.如权利要求2所述的消融导管，其特征在于：The ablation catheter of claim 2, wherein:所述第二测温传感器和所述第三测温传感器位于手术时不会进入人体内的位置。The second temperature measurement sensor and the third temperature measurement sensor are located at positions that will not enter the human body during surgery.如权利要求1所述的消融导管，其特征在于还包括注射探针，其与所述消融探针和所述测温探针的远端均相互独立。The ablation catheter of claim 1, further comprising an injection probe, which is independent of the distal ends of the ablation probe and the temperature measuring probe.如权利要求5所述的消融导管，其特征在于：The ablation catheter of claim 5, wherein:所述注射探针包括电极管体，内置于所述电极管体内的空心引导管，以及冷却液管，The injection probe includes an electrode tube body, a hollow guide tube built in the electrode tube body, and a coolant tube,所述空心引导管用于注射液体，所述冷却液管用于输送冷却剂。The hollow guide tube is used for injecting liquid, and the cooling liquid tube is used for conveying coolant.如权利要求6所述的消融导管，其特征在于：The ablation catheter of claim 6, wherein:所述注射探针还包括设置在所述电极管体远端的测温传感器。The injection probe also includes a temperature sensor arranged at the distal end of the electrode tube body.一种消融设备，其特征在于包括如权利要求1～7中任意一项所述的消融导管，还包括消融主机，所述消融主机通过连接线与所述控制手柄连接；An ablation device, characterized by comprising the ablation catheter according to any one of claims 1 to 7, and further comprising an ablation host, and the ablation host is connected to the control handle through a connecting wire;所述消融主机包括控制模块、温度监测模块和消融模块，所述控制模块分别与所述温度监测模块和所述消融模块连接；其中，The ablation host includes a control module, a temperature monitoring module, and an ablation module, and the control module is respectively connected to the temperature monitoring module and the ablation module; wherein,所述消融模块用于控制消融探针的能量；The ablation module is used to control the energy of the ablation probe;所述温度监测模块用于通过测温探针对交界区外的温度进行实时测量；The temperature monitoring module is used for real-time measurement of the temperature outside the boundary area through a temperature measuring probe;所述控制模块用于根据所述温度监测模块所采集的实时温度值，对所述消融模块的消融时间和功率进行控制。The control module is used to control the ablation time and power of the ablation module according to the real-time temperature value collected by the temperature monitoring module.如权利要求8所述的消融设备，其特征在于：The ablation device according to claim 8, wherein:所述消融主机还包括与控制模块连接的阻抗监测模块；所述阻抗监测模块用于获取所述消融探针和所述测温探针之间的组织的阻抗；The ablation host further includes an impedance monitoring module connected to the control module; the impedance monitoring module is used to obtain the impedance of the tissue between the ablation probe and the temperature measurement probe;所述控制模块，用于通过所述阻抗监测模块所获得的阻抗值对待消融组织的消融效果进行评估。The control module is used to evaluate the ablation effect of the tissue to be ablated through the impedance value obtained by the impedance monitoring module.如权利要求8所述的消融设备，其特征在于：The ablation device according to claim 8, wherein:所述温度监测模块还用于获取所述消融探针的第二温度传感器和第三温度传感器的检测温度；The temperature monitoring module is also used to obtain the detected temperatures of the second temperature sensor and the third temperature sensor of the ablation probe;所述控制模块还用于根据所述检测温度对消融温度进行控制。The control module is also used to control the ablation temperature according to the detected temperature.

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