CN111658125A - Ablation catheter and ablation device for image-guided ablation - Google Patents

Abstract

The invention discloses an ablation catheter and an ablation device for image-guided ablation. Wherein the ablation catheter comprises an elongated catheter having a first catheter branch and a second catheter branch disposed at a distal end of a catheter body; an ablation probe is arranged at the far end of the first catheter branch, and a temperature measuring probe is arranged at the far end of the second catheter branch; a control handle is disposed at the proximal end of the catheter body. Above-mentioned ablation catheter, when will melt the probe and place in waiting to melt the tissue and melt, can be with the mode of wicresoft, with small temperature probe location in waiting to melt the juncture of tissue and normal tissue, treat to melt the actual temperature of tissue junction area and carry out real-time accurate measurement, can accurate measurement wait to melt the temperature of tissue junction area to accurate control melts the operation implementation.

Description

Ablation catheter and ablation device for image-guided ablation

Technical Field

The invention relates to an ablation catheter for image-guided ablation, and also relates to ablation equipment comprising the ablation catheter, belonging to the field of medical instruments.

Background

Tumor hyperthermia refers to heating tumor tissue to a temperature above its thermotolerant temperature to kill cancer cells by some heating method, which includes both thermotherapy and hyperthermic coagulation. Thermotherapy is to heat the tumor to 42.5-45 deg.C for a certain time (usually several minutes to several tens of minutes) to inhibit the growth of tumor tissue and achieve the purpose of treating cancer. Hyperthermic coagulation is the complete necrosis of a tumor by heating the tumor tissue to a higher temperature (typically 60 ℃ for an instant, or 54 ℃ for one minute). In recent decades, 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 been developed rapidly, and has become a clinically practical tumor treatment means.

An effective thermal treatment must control the temperature distribution in the treated tissue within a suitable range, so accurate measurement and control of the tissue temperature is important. At present, invasive temperature measurement technology which is mostly adopted clinically is also called invasive measurement. As shown in fig. 1, atemperature sensor 12 is provided at the distal end of theablation probe 11, thetemperature sensor 12 is connected to theablation probe 11, and the temperature is directly measured at a single point or at multiple points by placing thetemperature sensor 12 such as a thermocouple or a thermistor together with theablation probe 11 at a site to be measured in the tumor tissue 10 (also in theboundary region 13 between the tumor tissue and the normal tissue). However, the method of measuring the temperature by invading the inside of the tumor is dangerous, and the temperature obtained by measuring the temperature inside the tumor needs to be combined with the experience of an operator or a preset algorithm to estimate the temperature distribution in the whole tumor range so as to control the process of tumor ablation. The temperature monitoring mode can not accurately measure the temperature distribution of the whole tumor range, and the temperature of the tumor junction area needs to be estimated, so that the ablation process is controlled according to the estimated temperature, the problem of inaccurate measurement exists, and the condition that the tumor is damaged by incomplete ablation or excessive ablation is easily caused.

The invasive temperature measurement is wound monitoring, and the current research direction at home and abroad is also noninvasive temperature measurement, for example: ultrasound, magnetic resonance, etc. However, ultrasound can only be performed without interference from gases, bones, etc., and magnetic resonance imaging equipment is expensive, and the high strength magnetic field makes the equipment and instruments used compatible with the magnetic field, further increasing cost and application limitations.

Cryoablation refers to rapid freezing of cancer tissue below a certain temperature (e.g., -60 ℃) followed by rewarming, resulting in dehydration rupture of cancer cells, or hypoxia of small tumor blood vessels, resulting in death of cancer cells. After the cryoablation operation is carried out, dead tumor tissues of the diseased region can be used as antigens to promote the body to generate anti-tumor immune response. The frozen cancer cells have higher sensitivity to chemotherapy or radiotherapy, so the treatment effect of the chemotherapy or radiotherapy on the cancer cells is enhanced. Similarly, the existing cryoablation needle has the problem of inaccurate temperature detection during ablation, and at this time, if ablation is still performed according to the originally planned ablation conditions, the problem of incomplete ablation or excessive ablation may be caused.

Disclosure of Invention

The invention aims to provide an ablation catheter for image-guided ablation.

Another object of the present invention is to provide an ablation apparatus including the ablation catheter described above.

In order to achieve the purpose, the invention adopts the following technical scheme:

according to a first aspect of embodiments of the present invention, there is provided an ablation catheter for image-guided ablation, comprising an elongated catheter body, at a distal end of which different first and second catheter branches are arranged; an ablation probe is arranged at the far end of the first catheter branch, and a temperature measuring probe is arranged at the far end of the second catheter branch; a control handle is disposed at the proximal end of the catheter body.

Preferably, in one embodiment provided by the present invention, the distal end of the ablation probe is a needle point type, and the distal end of the ablation probe is provided with an ablation electrode;

the far end of the temperature measuring probe is of a needle point type, and a first temperature measuring sensor is arranged at the far end of the temperature measuring probe.

Preferably, the first temperature measuring sensor is embedded at the far end of the temperature measuring probe, and the surface of the first temperature measuring sensor is flush with the surface of the temperature measuring probe.

Preferably, when the first thermometric sensor and the ablation electrode form a loop, the impedance of the body tissue between the thermometric probe and the ablation probe can be measured.

Preferably, in another embodiment provided by the present invention, the distal end of the temperature probe is a needle point type, and is provided with a first temperature sensor;

the near end of the ablation probe is provided with a second temperature measurement sensor and a third temperature measurement sensor, the second temperature measurement sensor is arranged at a position close to the refrigerant flowing to the far end of the ablation probe, and the third temperature measurement sensor is arranged at a position close to the backflow refrigerant.

Preferably, a refrigerant inlet pipeline and a refrigerant return pipeline are arranged in the catheter main body, and the refrigerant inlet pipeline extends from the first branch pipeline to the inside of the ablation probe and is communicated with the refrigerant inlet; the cryogen return line extends from the first branch line to the interior of the ablation probe and communicates with a cryogen return port,

the second temperature measuring sensor is arranged on the refrigerant liquid inlet pipeline; the third temperature measuring sensor is arranged on the refrigerant return pipeline.

Preferably, the second temperature sensor and the third temperature sensor are located at positions which cannot enter the human body during surgery.

According to a second aspect of the embodiments of the present invention, there is provided an ablation apparatus, including the ablation catheter described above, further including an ablation host, the ablation host being connected to the control handle through a connection line;

the ablation host comprises a control module, a temperature monitoring module and an ablation module, wherein the control module is respectively connected with the temperature monitoring module and the ablation module; wherein,

the ablation module is used for controlling the energy of the ablation probe;

the temperature monitoring module is used for measuring the temperature outside the junction area in real time through the temperature measuring probe;

the control module is used for controlling the ablation time and power of the ablation module according to the real-time temperature value acquired by the temperature monitoring module.

Preferably, in an embodiment provided by the present invention, the ablation host further includes an impedance monitoring module connected to the control module; the impedance monitoring module is used for acquiring the impedance of the tissue between the ablation probe and the temperature measuring probe; the control module is used for evaluating the ablation effect of the tissue to be ablated through the impedance value obtained by the impedance monitoring module.

Preferably, in a further embodiment provided by the present invention, the temperature monitoring module is further configured to obtain an ablation probe cryogen inlet temperature and a cryogen outlet temperature; the control module is further configured to control an ablation temperature based on the cryogen inlet temperature and the cryogen outlet temperature.

According to the ablation catheter for the image-guided ablation, the ablation probe and the temperature measuring probe are respectively arranged, the ablation probe is placed in the tissue to be ablated for ablation, the temperature measuring probe can be positioned at the junction of the tissue to be ablated and the normal tissue, the actual temperature of the junction area of the tissue to be ablated is accurately measured in real time, the ablation process of the tissue to be ablated is monitored through the temperature measuring probe, the temperature of the junction area of the tissue to be ablated can be accurately measured, the implementation of an ablation operation is accurately controlled, the tissue to be ablated is completely ablated, the recurrence of the tissue to be ablated is prevented, the normal tissue can be effectively protected, and excessive ablation is prevented.

Drawings

FIG. 1 is a schematic diagram of invasive thermometry in a conventional interventional procedure;

FIG. 2 is a schematic view of the interface region of the present invention;

FIG. 3 is a schematic view of a thermometry mode of an ablation catheter according to a first embodiment of the present invention;

fig. 4 is a schematic structural view of an ablation apparatus provided in accordance with a first embodiment of the present invention;

fig. 5 is a block diagram of an ablation host according to a first embodiment of the present invention;

FIG. 6 is a schematic view of an ablation probe in an ablation catheter according to a second embodiment of the invention;

fig. 7 is a schematic structural view of an ablation device provided in accordance with a second embodiment of the invention;

fig. 8 is a block diagram of an ablation host according to a second embodiment of the present invention.

Detailed Description

The technical solution of the present invention is further described in detail with reference to the accompanying drawings and specific embodiments.

As is well known, according to the biopsy result, the infiltration range of tumor cells is wider than the high signal range of the low-density image on CT and the T2 weighted image on MRI, so that the infiltration range of tumor cells cannot be accurately determined according to the image, which results in that many interventional operations do not ablate all the tumor tissue and the tissue within the infiltration range, and the curative effect of the tumor operation is significantly reduced.

In the schematic CT image shown in fig. 2, thetissue 10 to be ablated (e.g., tumor tissue) infiltrates into the normal tissue outside the edge of thetissue 10 to be ablated. The physician can determine from the image that the normal tissue is completely free oftumor cells 15. The region between the edge of thetissue 10 to be ablated and the normal tissue (without tumor cells) 15, i.e. the region indicated by the arrow in the figure, is theinterface region 13. Theinterface region 13 of the present invention refers to the portion of tissue that transitions from the edge (the edge viewed imagewise) of thetissue 10 to be ablated (e.g., tumor tissue) to thenormal tissue 15 surrounding the tumor that is completely free of tumor cells, with a small number of tumor cells and a large number of normal tissue in theinterface region 13.

The ablation catheter provided by the invention comprises the independently arranged temperature probe, and the temperature measuring point (the point of the temperature probe entering the tissue to be ablated) 18 of the temperature probe is positioned outside thejunction area 13 of thetissue 10 to be ablated and thenormal tissue 15, so that the temperature probe is positioned in thenormal tissue 15 and close to thejunction area 13, and the temperature monitoring effect in the ablation operation process is improved.

< first embodiment >

The ablation catheter and the ablation device provided by the invention are suitable for image-guided ablation operation. As shown in fig. 3 and 4, the radiofrequency catheter provided by the invention has theindependent ablation probe 20 and thetemperature probe 21, and the actual temperature of the junction area of the tissue to be ablated 10 is accurately measured in real time by placing theablation probe 20 in the tissue to be ablated 10 (such as a tumor) and positioning thetemperature probe 21 outside the junction area 13 (of the tumor tissue and the normal tissue) of the tissue to be ablated 10 and thenormal tissue 15, so that the implementation of the ablation operation can be accurately controlled, the tissue to be ablated is completely ablated, the recurrence of the tissue to be ablated is prevented, the normal tissue can be effectively protected, and the excessive ablation is prevented.

Specifically, as shown in fig. 4, the present invention provides a radio frequency catheter, which includes an elongated cathetermain body 24, and afirst branch catheter 25 and asecond branch catheter 26 which are different and are disposed at the distal end of the cathetermain body 24. The distal end of thefirst branch catheter 25 is provided with theablation probe 20, theablation probe 20 has higher hardness, the distal end is provided with a needle point shape so as to facilitate the penetration of thetissue 10 to be ablated, and theablation probe 20 can be made of a medical puncture needle material, such as stainless steel or tool steel. The distal end of thesecond ablation catheter 26 is provided with thetemperature probe 21, the hardness of thetemperature probe 21 is high, the distal end of thetemperature probe 21 is in a needle point shape, and thetemperature probe 21 can independently penetrate into the position outside thejunction area 13 of thetissue 10 to be ablated and thenormal tissue 15. Thetemperature probe 21 can also be made of a medical needle material such as stainless steel or tool steel. Thefirst branch catheter 25 and thesecond branch catheter 26 are shorter, softer and more flexible relative to the cathetermain body 24, so that theablation probe 20 and thetemperature probe 21 can be held conveniently for puncture operation.

A control handle 27 is provided at the proximal end of thecatheter body 24. A first and a second parallel wires are provided inside thecatheter body 24. The distal end of the first wire passes inside 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 acontrol handle 27. The distal end of the second guide wire passes through the inside of thesecond branch catheter 26 and is connected with the proximal end of thetemperature probe 21; the proximal end of the second wire is connected to acontrol handle 27.

Therf probe 20 includes a hollow puncture needle, anablation electrode 23 is disposed at a distal end (which may also be an end near a lesion) of the puncture needle, and a distal end of a first wire penetrates into the interior of the puncture needle and is connected to theablation electrode 23 for transmitting 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, so that the puncture operation is convenient.

Thetemperature probe 21 includes a hollow puncture needle, and a first temperature sensor 22 (e.g., a thermocouple, a thermistor, etc.) is provided at a distal end (which may also be an end near a lesion) of the puncture needle, and a distal end of a second wire penetrates the inside of the puncture needle and is connected to thefirst temperature sensor 22. Preferably, thefirst temperature sensor 22 is embedded in the puncture needle, and the surface of thefirst temperature sensor 22 is flush with the puncture needle, so that the puncture operation is convenient.

The firsttemperature measuring sensor 22 and theablation electrode 23 form a loop, and the impedance of the tissue to be ablated 10 between theablation probe 20 and thetemperature measuring probe 21 can be measured before ablation, so that the first impedance is obtained. After the ablation is completed, a second impedance is obtained by measuring the impedance of the tissue to be ablated again. The first impedance is compared to the second impedance to assess the effectiveness of ablation.

Preferably, during the image-guided ablation treatment operation, the doctor controls the measurement position of thefirst temperature sensor 22 in thetemperature probe 21 within a range of 2-10 mm away from theboundary region 13 between thetissue 10 to be ablated and the normal tissue 15 (i.e., the side close to the normal tissue without tumor cells in fig. 2) by observing the image. Specifically, how much tissue of the junction area outside the tumor margin needs to be ablated by each tumor needs to be determined by a doctor according to the tumor condition, and therefore, the measurement position of the firsttemperature measurement sensor 22 is selected by the doctor within the range of 2-10 mm outside the junction area.

More preferably, the measurement position of the firstthermometric sensor 22 is outside the position farthest from theablation electrode 23 in the junction area 13 (the side away from the ablation electrode 13). The position of thefirst temperature sensor 22 can realize that the distance from theablation electrode 23 to thefirst temperature sensor 22 is greater than the distance from theablation electrode 23 to any point on the boundary area of the tissue (tumor tissue) 10 to be ablated and greater than the distance from theablation electrode 23 to any point on theboundary area 13, so that the temperature of thefirst temperature sensor 22 is lower than the temperature of any point on the boundary area of the tissue (tumor tissue) 10 to be ablated and lower than the temperature of any point on theboundary area 13. Therefore, as long as the temperature of thefirst temperature sensor 22 is ensured to be higher than the preset temperature (for example, 60 degrees) for killing tumor cells, the temperature of the whole 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 of the whole tissue to be ablated (tumor tissue) 10 and thejunction area 13.

The control handle 27 is provided with a plurality of joints for realizing the connection of theablation probe 20, thetemperature probe 21 and theablation host 30.

When the ablation catheter is used for ablation, the actual temperature of the interface area of the tissue to be ablated 10 can be accurately measured in real time by placing theablation probe 20 in the tissue to be ablated 10 (such as a tumor) and positioning thetemperature measuring probe 21 outside the interface area of the tissue to be ablated 10 and thenormal tissue 15 and close to theinterface area 13. The part measured by thetemperature measuring probe 21 is the junction area of thetissue 10 to be ablated, and since the puncture ablation part of theablation probe 20 is usually the central position of thetissue 10 to be ablated, the temperature outside the junction area (outside far away from the tumor tissue) on one side of the puncture ablation part can be measured, so that the implementation of the ablation operation can be accurately controlled, the tissue to be ablated is completely ablated, the recurrence of the tissue to be ablated is prevented, the normal tissue can be effectively protected, and the excessive ablation is prevented.

In addition, thetemperature probe 21 and theablation probe 20 are independently arranged, so that thetemperature probe 21 can be arranged in normal tissues at the edge of thetissue 10 to be ablated, and on one hand, the temperature of a junction area of the tissue to be ablated can be measured in real time; on the other hand, thetemperature measuring probe 21 is not directly contacted with thetissue 10 to be ablated, so that the tissue to be ablated is prevented from spreading along the needle channel.

As shown in fig. 4 and 5, the ablation apparatus provided by the present invention, in addition to the ablation catheter, further includes anablation host 30 and aconnection line 31, wherein theconnection line 31 is used for connecting theablation host 30 and the control handle 27. One end of the connectingwire 31 is respectively connected with theablation probe 20 and thetemperature measuring probe 21 through a first conducting wire and a second conducting wire; the other end of the connectingwire 31 is respectively connected with anablation module 33, atemperature monitoring module 34 and animpedance measuring module 35 in theablation host 30.

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 with theablation module 33, and thefirst temperature sensor 22 is connected with thetemperature monitoring module 34; also, theablation electrode 23 and the firstthermometric sensor 22 may be simultaneously connected to theimpedance measuring module 35.

Preferably, the connectingwire 31 is a wire formed by integrating a plurality of wires, and theablation host 30 and the ablation catheter can be connected by inserting both ends of the connectingwire 31 into corresponding positions of the control handle 27 and theablation host 30, respectively.

Theablation module 33 is used to control theablation electrode 23 to deliver radiofrequency energy to thetissue 10 to be ablated. Thetemperature monitoring module 34 is used for measuring the temperature of thejunction area 13 of the tissue to be ablated 10 and thenormal tissue 15 through the firsttemperature measuring sensor 22. Theimpedance monitoring module 35 is used for acquiring the impedance of the tissue between theablation probe 20 and thethermometric probe 21, so as to evaluate the ablation effect of the tissue to be ablated.

Thecontrol module 32 is used for controlling the ablation time and power of theablation module 33 according to the real-time temperature value collected by thetemperature monitoring module 34, so as to achieve the purpose of accurate ablation. Wherein, when the temperature around thetemperature probe 21 reaches a set threshold (e.g. 42.5 °) and is kept for a set time (e.g. 1min), it indicates that a part of normal tissue cells of the tissue to be ablated, including the boundary zone, have been killed, and the ablation can be stopped. At the moment, thetissue 10 to be ablated and thenormal tissue 20 around 1-2 cm are killed, so that the effect of the ablation operation can meet the requirement of surgical excision. Meanwhile, thecontrol module 32 is used for monitoring the electrical impedance change between theablation probe 20 and thetemperature probe 21 according to theimpedance monitoring module 35, so that the ablation state of the tissue to be ablated can be estimated.

< second embodiment >

The ablation catheter and ablation device provided by the second embodiment are equally applicable to image-guided cryoablation procedures. The radiofrequency catheter is provided with theindependent ablation probe 40 and thetemperature probe 51, theablation probe 40 is penetrated into a tissue to be ablated (such as a tumor), thetemperature probe 51 is positioned outside a junction area 13 (of the tumor tissue and the normal tissue) of thetissue 10 to be ablated and thenormal tissue 15, and the actual temperature of the junction area of thetissue 10 to be ablated is accurately measured in real time, so that the implementation of an ablation operation can be accurately controlled, the tissue to be ablated is completely ablated, the recurrence of the tissue to be ablated is prevented, the normal tissue can be effectively protected, and excessive ablation is prevented.

In this embodiment, as shown in fig. 6 and 7, the rf catheter includes anelongated catheter body 55, and afirst branch catheter 53 and asecond branch catheter 54, which are different flexible, are provided at the distal end of thecatheter body 55. Anablation probe 40 is arranged at the distal end (close to thetissue 10 to be ablated) of thefirst branch catheter 53, the hardness of theablation probe 40 is high, and the distal end is arranged in a needle point shape so as to be convenient for penetrating into thetissue 10 to be ablated. The distal end (close to thetissue 10 to be ablated) of thesecond ablation catheter 54 is provided with atemperature probe 51, the hardness of thetemperature probe 51 is higher, the distal end of thetemperature probe 51 is in a needle point shape, and thetemperature probe 51 can independently penetrate into the position outside thejunction area 13 of thetissue 10 to be ablated and thenormal tissue 15.

A control handle 56 is provided at the proximal end of thecatheter body 55. Acoolant inlet line 45 and acoolant return line 46 are provided inside the pipemain body 55. Thecoolant inlet line 45 has one end connected to the control handle 56 and the other end extending from thefirst branch line 53 to the interior of theablation probe 40, and forms acoolant inlet 43 at the distal end of theablation probe 40; thecryogen return line 46 is connected at one end to acontrol handle 56 and extends at the other end from thefirst branch line 53 to the interior of theablation probe 40, forming acryogen return port 44 at the distal end of theablation probe 40.

A plurality of parallel wires are provided inside the cathetermain body 55. Wherein the distal end of the first lead wire passes through the inside of thefirst branch catheter 53 and is connected with thesecond temperature sensor 41 arranged in theablation probe 40; the proximal end of the first wire is connected to acontrol handle 56. The distal end of the third wire passes through the inside of thefirst branch catheter 53 and is connected with the third temperature measuring sensor 42 arranged in theablation probe 40; the proximal end of the third wire is connected to acontrol handle 56. The secondtemperature measuring sensor 41 is arranged at the near end of the refrigerantliquid inlet pipeline 45 and is used for measuring the temperature of the refrigerant flowing to therefrigerant liquid inlet 43; a third temperature sensor 42 is disposed at the proximal end of thecoolant return line 46 for measuring the temperature of the returning coolant. In other words, the second temperature sensor is positioned proximate to the coolant flowing toward the distal end of the ablation probe, and the third temperature sensor is positioned proximate to the returning coolant. Thesecond temperature sensor 41 and the third temperature sensor 42 for measuring the inlet temperature and the return temperature of the coolant are located at the near end, and do not enter the human body even during the operation (for example, at the connection position of thefirst branch catheter 53 and the ablation probe 40), so that the diameter of the far end of theablation probe 40 can be reduced, and the wound caused by the far end of theablation probe 40 penetrating into the body can be reduced.

The distal end of the second lead passes through the inside of thesecond branch catheter 54 and is connected with the firstthermometric sensor 52 arranged in thethermometric probe 51; the proximal end of the second wire is connected to acontrol handle 56. The firstthermometric sensor 52 is used to measure the temperature outside thejunction 13 of the tissue to be ablated 10 andnormal tissue 15. Thefirst temperature sensor 52 is used in the same manner and function as thefirst temperature sensor 22 in the first embodiment. And will not be described in detail herein.

The control handle 56 is provided with a plurality of joints for connecting theablation probe 40, thetemperature probe 51 and theablation host 60.

When the ablation catheter is used for ablation, the actual temperature of the interface area of the tissue to be ablated 10 can be accurately measured in real time by sending theablation probe 40 into the tissue to be ablated 10 (such as a tumor) and positioning thetemperature probe 51 outside the interface area of the tissue to be ablated 10 and thenormal tissue 15 and close to theinterface area 13. The part measured by thetemperature probe 51 is the outer side of the junction area of thetissue 10 to be ablated (close to the normal tissue without tumor cells), and since the puncture ablation part of theablation probe 40 is usually the central position of thetissue 10 to be ablated, the temperature in the outer part of the junction area (far away from the outer part of the tumor tissue) on one side can be measured, so that the temperature in the whole junction area can be judged to reach the expected temperature, the cryoablation range can be accurately controlled, the tissue to be ablated and the tissue in the junction area are completely ablated, the recurrence is prevented, the normal tissue can be effectively protected, and the excessive ablation is avoided.

In addition, thetemperature probe 51 can be arranged in the normal tissue at the edge of thetissue 10 to be ablated by independently arranging thetemperature probe 51 and theablation probe 40, so that on one hand, the temperature of thejunction area 13 of the tissue to be ablated can be measured in real time; on the other hand, thetemperature probe 51 does not directly contact thetissue 10 to be ablated, preventing the tissue to be ablated from spreading along the needle track.

As shown in fig. 7 and 8, the ablation apparatus provided by the present invention, in addition to the ablation catheter, further includes anablation host 60 and aconnection line 61, wherein theconnection line 61 is used for connecting theablation host 60 and the control handle 56. One end of the connectingwire 61 is respectively connected with the temperature measuring sensors in theablation probe 40 and thetemperature measuring probe 51 through different conducting wires; the other end of the connectingwire 61 is connected with atemperature monitoring module 64 in theablation host 60. In addition, the connectingline 61 further includes two refrigerant connecting lines, and the two refrigerant connecting lines are respectively communicated with the refrigerant inlet line and the refrigerant return line to form a refrigerant circulation line. Wherein, the end of the refrigerant connecting pipeline communicated with the refrigerantliquid inlet pipeline 45 is connected with arefrigerant storage bottle 67 for providing refrigerant; preferably, another refrigerant storage bottle is connected to the end of the refrigerant connection line communicating with therefrigerant return line 46 for storing the circulated refrigerant. Acontrol valve 66 is provided on the refrigerant circulation line.

Theablation host 60 includes acontrol module 62, anablation module 63, and atemperature monitoring module 64. Thecontrol module 62 is connected with thetemperature monitoring module 63 and theablation module 64 respectively. Thecontrol valve 66 on the refrigerating fluid circulating pipeline is connected with theablation module 63, and thefirst temperature sensor 52, thesecond temperature sensor 41 and the third temperature sensor 42 are respectively connected with thetemperature monitoring module 64.

Preferably, theconnection line 61 is a connection line integrated by a plurality of wires and a plurality of coolant connection pipelines, and the connection between theablation host 60 and the ablation catheter can be realized by inserting both ends of theconnection line 61 into the corresponding positions of the control handle 56 and theablation host 60, respectively.

Theablation module 63 is used to control theablation probe 40 to deliver cryogenic energy to thetissue 10 to be ablated. Thetemperature monitoring module 64 is used for measuring the temperature of the junction area 16 of the tissue to be ablated 10 and thenormal tissue 15 through the firsttemperature measuring sensor 52, measuring the liquid inlet temperature of the refrigerant through the secondtemperature measuring sensor 41, and measuring the backflow temperature of the refrigerant through the third temperature measuring sensor 42.

Thecontrol module 62 is used for controlling the ablation time and power of theablation module 63 according to the real-time temperature value collected by thetemperature monitoring module 64, so as to achieve the purpose of accurate ablation. Wherein, when the temperature around thetemperature probe 51 reaches a set threshold (e.g., -60 °) and is maintained for a set time, it indicates that a portion of normal tissue cells of the tissue to be ablated, including the junction area, has been killed, and the ablation is stopped. At this time, thetissue 10 to be ablated and the surrounding normal tissue 20 (the region where the tumor infiltration occurs) of about 2mm are all killed, so as to ensure that the effect of the ablation operation meets the requirement of surgical resection.

In the process of the cryoablation, thecontrol module 62 is configured to monitor an actual ablation condition of the tissue to be ablated according to the temperature (lower than-40 degrees, more preferably, 42 degrees below zero to 50 degrees below zero) of the junction region of the tissue to be ablated, which is measured by the firsttemperature measurement sensor 52; thecontrol module 62 is further configured to control the ablation effect of the tissue to be ablated according to the difference between the coolant inlet temperature and the coolant return temperature measured by thesecond temperature sensor 41 and the third temperature sensor 42. Specifically, according to the difference between the coolant inlet temperature and the coolant return temperature measured by thesecond temperature sensor 41 and the third temperature sensor 42, and by combining the information such as the flow rate and the tube diameter of the coolant, the heat conducted by the coolant in the tissue to be ablated can be calculated. Then, according to the heat, the volume of the tissue to be ablated and the junction area seen in the imaging can be combined, the heating condition of the tissue to be ablated (for example, the temperature of the head part of the ablation needle) can be estimated, and therefore the ablation effect can be judged.

In summary, the ablation catheter and the ablation device provided by the invention comprise the independent ablation probe and the temperature probe, the tiny temperature probe is arranged outside the junction area of the tissue to be ablated and the normal tissue in a minimally invasive manner, the temperature change of the region is monitored in real time in the ablation operation, the implementation of the ablation operation is accurately controlled, the tissue to be ablated is completely ablated, the recurrence of the tissue to be ablated is prevented, the normal tissue can be effectively protected, and the excessive ablation is prevented.

The independent design scheme of the ablation probe and the temperature measuring probe provided by the invention is different from the conventional design concept. The conventional design idea is to reduce trauma by combining the two and delivering the ablation probe and the temperature probe through a single wound. The invention needs to send the ablation probe and the temperature measuring probe into two wounds respectively, or send the ablation probe and the temperature measuring probe into two wounds respectively, but the temperature measuring probe is arranged outside the junction area of the tissue to be ablated and the normal tissue, which need to be ablated, to monitor the temperature change of the region in real time in the ablation operation, accurately control the implementation of the ablation operation, achieve the effect of completely ablating the whole tumor tissue and the normal tissue infiltrated by the tumor tissue, and avoid the recurrence of the tumor.

The ablation catheter and ablation device for image guided ablation provided by the present invention are described in detail above. It will be apparent to those skilled in the art that any obvious modifications thereof can be made without departing from the spirit of the invention, which infringes the patent right of the invention and bears the corresponding legal responsibility.

Claims (10)

1. An ablation catheter for image-guided ablation, comprising an elongated catheter body, at the distal end of which different first and second catheter branches are arranged; an ablation probe is arranged at the far end of the first catheter branch, and a temperature measuring probe is arranged at the far end of the second catheter branch; a control handle is disposed at the proximal end of the catheter body.

2. The ablation catheter of claim 1, wherein:

the far end of the ablation probe is of a needle point type, and an ablation electrode is arranged at the far end of the ablation probe;

the far end of the temperature measuring probe is of a needle point type, and a first temperature measuring sensor is arranged at the far end of the temperature measuring probe.

3. The ablation catheter of claim 2, wherein:

the first temperature measurement sensor is embedded at the far 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.

4. The ablation catheter of claim 2, wherein:

when the first temperature measuring sensor and the ablation electrode form a loop, the impedance of the human tissue between the temperature measuring probe and the ablation probe can be measured.

5. The ablation catheter of claim 1, wherein:

the far end of the temperature measuring probe is of a needle point type and is provided with a first temperature measuring sensor;

the near end of the ablation probe is provided with a second temperature measurement sensor and a third temperature measurement sensor, the second temperature measurement sensor is arranged at a position close to the refrigerant flowing to the far end of the ablation probe, and the third temperature measurement sensor is arranged at a position close to the backflow refrigerant.

6. The ablation catheter of claim 5, wherein:

a refrigerant liquid inlet pipeline and a refrigerant return pipeline are arranged in the catheter main body, and the refrigerant liquid inlet pipeline extends from the near end of the ablation probe and is communicated with a refrigerant liquid inlet; the cryogen return line extends from the proximal end of the ablation probe and communicates with a cryogen return port;

the second temperature measuring sensor is arranged on the refrigerant liquid inlet pipeline; the third temperature measuring sensor is arranged on the refrigerant return pipeline.

7. The ablation catheter of claim 6, wherein:

the second temperature measurement sensor and the third temperature measurement sensor are positioned at positions which cannot enter the human body during operation.

8. An ablation device, characterized by comprising the ablation catheter of any one of claims 1 to 7, and further comprising an ablation host, wherein the ablation host is connected with the control handle through a connecting wire;

the ablation host comprises a control module, a temperature monitoring module and an ablation module, wherein the control module is respectively connected with the temperature monitoring module and the ablation module; wherein,

the ablation module is used for controlling the energy of the ablation probe;

the temperature monitoring module is used for measuring the temperature outside the junction area in real time through the temperature measuring probe;

the control module is used for controlling the ablation time and power of the ablation module according to the real-time temperature value acquired by the temperature monitoring module.

9. The ablation apparatus of claim 8, wherein:

the ablation host machine further comprises an impedance monitoring module connected with the control module; the impedance monitoring module is used for acquiring the impedance of the tissue between the ablation probe and the temperature measuring probe;

the control module is used for evaluating the ablation effect of the tissue to be ablated through the impedance value obtained by the impedance monitoring module.

10. The ablation apparatus of claim 8, wherein:

the temperature monitoring module is also used for acquiring the temperature of a refrigerant inlet and the temperature of a refrigerant outlet of the ablation probe;

the control module is further configured to control an ablation temperature based on the cryogen inlet temperature and the cryogen outlet temperature.

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