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

Ablation catheter and ablation device for image-guided ablation Download PDF

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Publication number
CN111658125A
CN111658125A CN202010399304.5A CN202010399304A CN111658125A CN 111658125 A CN111658125 A CN 111658125A CN 202010399304 A CN202010399304 A CN 202010399304A CN 111658125 A CN111658125 A CN 111658125A
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ablation
temperature
probe
catheter
tissue
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董永华
滕臬军
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Zhishan Interventional Ablation Technology Research Institute Nanjing Co ltd
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Zhishan Interventional Ablation Technology Research Institute Nanjing Co ltd
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Priority to CN202010399304.5A priority Critical patent/CN111658125A/en
Publication of CN111658125A publication Critical patent/CN111658125A/en
Priority to PCT/CN2021/093262 priority patent/WO2021228122A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1402—Probes for open surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00714—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00797—Temperature measured by multiple temperature sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0293—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument interstitially inserted into the body, e.g. needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2065—Tracking using image or pattern recognition

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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, a temperature sensor 12 is provided at the distal end of the ablation probe 11, the temperature sensor 12 is connected to the ablation probe 11, and the temperature is directly measured at a single point or at multiple points by placing the temperature sensor 12 such as a thermocouple or a thermistor together with the ablation probe 11 at a site to be measured in the tumor tissue 10 (also in the boundary 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, the tissue 10 to be ablated (e.g., tumor tissue) infiltrates into the normal tissue outside the edge of the tissue 10 to be ablated. The physician can determine from the image that the normal tissue is completely free of tumor cells 15. The region between the edge of the tissue 10 to be ablated and the normal tissue (without tumor cells) 15, i.e. the region indicated by the arrow in the figure, is the interface region 13. The interface region 13 of the present invention refers to the portion of tissue that transitions from the edge (the edge viewed imagewise) of the tissue 10 to be ablated (e.g., tumor tissue) to the normal 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 the interface 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 the junction area 13 of the tissue 10 to be ablated and the normal tissue 15, so that the temperature probe is positioned in the normal tissue 15 and close to the junction 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 the independent ablation probe 20 and the temperature 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 the ablation probe 20 in the tissue to be ablated 10 (such as a tumor) and positioning the temperature probe 21 outside the junction area 13 (of the tumor tissue and the normal tissue) of the tissue to be ablated 10 and the normal 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 catheter main body 24, and a first branch catheter 25 and a second branch catheter 26 which are different and are disposed at the distal end of the catheter main body 24. The distal end of the first branch catheter 25 is provided with the ablation probe 20, the ablation probe 20 has higher hardness, the distal end is provided with a needle point shape so as to facilitate the penetration of the tissue 10 to be ablated, and the ablation probe 20 can be made of a medical puncture needle material, such as stainless steel or tool steel. The distal end of the second ablation catheter 26 is provided with the temperature probe 21, the hardness of the temperature probe 21 is high, the distal end of the temperature probe 21 is in a needle point shape, and the temperature probe 21 can independently penetrate into the position outside the junction area 13 of the tissue 10 to be ablated and the normal tissue 15. The temperature probe 21 can also be made of a medical needle material such as stainless steel or tool steel. The first branch catheter 25 and the second branch catheter 26 are shorter, softer and more flexible relative to the catheter main body 24, so that the ablation probe 20 and the temperature probe 21 can be held conveniently for puncture operation.
A control handle 27 is provided at the proximal end of the catheter body 24. A first and a second parallel wires are provided inside the catheter body 24. The distal end of the first wire passes inside the first branch catheter 25 and is connected to the proximal end of the ablation probe 20; the proximal end of the first wire is connected to a control handle 27. The distal end of the second guide wire passes through the inside of the second branch catheter 26 and is connected with the proximal end of the temperature probe 21; the proximal end of the second wire is connected to a control handle 27.
The rf probe 20 includes a hollow puncture needle, an ablation 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 the ablation electrode 23 for transmitting energy to the ablation electrode 23. Preferably, the ablation electrode 23 is embedded in the puncture needle, and the surface of the ablation electrode 23 is flush with the puncture needle, so that the puncture operation is convenient.
The temperature 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 the first temperature sensor 22. Preferably, the first temperature sensor 22 is embedded in the puncture needle, and the surface of the first temperature sensor 22 is flush with the puncture needle, so that the puncture operation is convenient.
The first temperature measuring sensor 22 and the ablation electrode 23 form a loop, and the impedance of the tissue to be ablated 10 between the ablation probe 20 and the temperature 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 the first temperature sensor 22 in the temperature probe 21 within a range of 2-10 mm away from the boundary region 13 between the tissue 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 first temperature 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 first thermometric sensor 22 is outside the position farthest from the ablation electrode 23 in the junction area 13 (the side away from the ablation electrode 13). The position of the first temperature sensor 22 can realize that the distance from the ablation electrode 23 to the first temperature sensor 22 is greater than the distance from the ablation electrode 23 to any point on the boundary area of the tissue (tumor tissue) 10 to be ablated and greater than the distance from the ablation electrode 23 to any point on the boundary area 13, so that the temperature of the first 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 the boundary area 13. Therefore, as long as the temperature of the first 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 the junction 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 the junction area 13.
The control handle 27 is provided with a plurality of joints for realizing the connection of the ablation probe 20, the temperature probe 21 and the ablation 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 the ablation probe 20 in the tissue to be ablated 10 (such as a tumor) and positioning the temperature measuring probe 21 outside the interface area of the tissue to be ablated 10 and the normal tissue 15 and close to the interface area 13. The part measured by the temperature measuring probe 21 is the junction area of the tissue 10 to be ablated, and since the puncture ablation part of the ablation probe 20 is usually the central position of the tissue 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, the temperature probe 21 and the ablation probe 20 are independently arranged, so that the temperature probe 21 can be arranged in normal tissues at the edge of the tissue 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, the temperature measuring probe 21 is not directly contacted with the tissue 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 an ablation host 30 and a connection line 31, wherein the connection line 31 is used for connecting the ablation host 30 and the control handle 27. One end of the connecting wire 31 is respectively connected with the ablation probe 20 and the temperature measuring probe 21 through a first conducting wire and a second conducting wire; the other end of the connecting wire 31 is respectively connected with an ablation module 33, a temperature monitoring module 34 and an impedance measuring module 35 in the ablation host 30.
As shown in fig. 5, the ablation host 30 includes a control module 32, an ablation module 33, a temperature monitoring module 34, and an impedance measurement module 35; the control module 32 is connected to the temperature monitoring module 33, the ablation module 34 and the impedance measurement module 35, respectively. The ablation electrode 23 is connected with the ablation module 33, and the first temperature sensor 22 is connected with the temperature monitoring module 34; also, the ablation electrode 23 and the first thermometric sensor 22 may be simultaneously connected to the impedance measuring module 35.
Preferably, the connecting wire 31 is a wire formed by integrating a plurality of wires, and the ablation host 30 and the ablation catheter can be connected by inserting both ends of the connecting wire 31 into corresponding positions of the control handle 27 and the ablation host 30, respectively.
The ablation module 33 is used to control the ablation electrode 23 to deliver radiofrequency energy to the tissue 10 to be ablated. The temperature monitoring module 34 is used for measuring the temperature of the junction area 13 of the tissue to be ablated 10 and the normal tissue 15 through the first temperature measuring sensor 22. The impedance monitoring module 35 is used for acquiring the impedance of the tissue between the ablation probe 20 and the thermometric probe 21, so as to evaluate the ablation effect of the tissue to be ablated.
The control module 32 is used for controlling the ablation time and power of the ablation module 33 according to the real-time temperature value collected by the temperature monitoring module 34, so as to achieve the purpose of accurate ablation. Wherein, when the temperature around the temperature 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, the tissue 10 to be ablated and the normal tissue 20 around 1-2 cm are killed, so that the effect of the ablation operation can meet the requirement of surgical excision. Meanwhile, the control module 32 is used for monitoring the electrical impedance change between the ablation probe 20 and the temperature probe 21 according to the impedance 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 the independent ablation probe 40 and the temperature probe 51, the ablation probe 40 is penetrated into a tissue to be ablated (such as a tumor), the temperature probe 51 is positioned outside a junction area 13 (of the tumor tissue and the normal tissue) of the tissue 10 to be ablated and the normal tissue 15, and the actual temperature of the junction area of the tissue 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 an elongated catheter body 55, and a first branch catheter 53 and a second branch catheter 54, which are different flexible, are provided at the distal end of the catheter body 55. An ablation probe 40 is arranged at the distal end (close to the tissue 10 to be ablated) of the first branch catheter 53, the hardness of the ablation probe 40 is high, and the distal end is arranged in a needle point shape so as to be convenient for penetrating into the tissue 10 to be ablated. The distal end (close to the tissue 10 to be ablated) of the second ablation catheter 54 is provided with a temperature probe 51, the hardness of the temperature probe 51 is higher, the distal end of the temperature probe 51 is in a needle point shape, and the temperature probe 51 can independently penetrate into the position outside the junction area 13 of the tissue 10 to be ablated and the normal tissue 15.
A control handle 56 is provided at the proximal end of the catheter body 55. A coolant inlet line 45 and a coolant return line 46 are provided inside the pipe main body 55. The coolant inlet line 45 has one end connected to the control handle 56 and the other end extending from the first branch line 53 to the interior of the ablation probe 40, and forms a coolant inlet 43 at the distal end of the ablation probe 40; the cryogen return line 46 is connected at one end to a control handle 56 and extends at the other end from the first branch line 53 to the interior of the ablation probe 40, forming a cryogen return port 44 at the distal end of the ablation probe 40.
A plurality of parallel wires are provided inside the catheter main body 55. Wherein the distal end of the first lead wire passes through the inside of the first branch catheter 53 and is connected with the second temperature sensor 41 arranged in the ablation probe 40; the proximal end of the first wire is connected to a control handle 56. The distal end of the third wire passes through the inside of the first branch catheter 53 and is connected with the third temperature measuring sensor 42 arranged in the ablation probe 40; the proximal end of the third wire is connected to a control handle 56. The second temperature measuring sensor 41 is arranged at the near end of the refrigerant liquid inlet pipeline 45 and is used for measuring the temperature of the refrigerant flowing to the refrigerant liquid inlet 43; a third temperature sensor 42 is disposed at the proximal end of the coolant 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. The second 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 the first branch catheter 53 and the ablation probe 40), so that the diameter of the far end of the ablation probe 40 can be reduced, and the wound caused by the far end of the ablation probe 40 penetrating into the body can be reduced.
The distal end of the second lead passes through the inside of the second branch catheter 54 and is connected with the first thermometric sensor 52 arranged in the thermometric probe 51; the proximal end of the second wire is connected to a control handle 56. The first thermometric sensor 52 is used to measure the temperature outside the junction 13 of the tissue to be ablated 10 and normal tissue 15. The first temperature sensor 52 is used in the same manner and function as the first 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 the ablation probe 40, the temperature probe 51 and the ablation 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 the ablation probe 40 into the tissue to be ablated 10 (such as a tumor) and positioning the temperature probe 51 outside the interface area of the tissue to be ablated 10 and the normal tissue 15 and close to the interface area 13. The part measured by the temperature probe 51 is the outer side of the junction area of the tissue 10 to be ablated (close to the normal tissue without tumor cells), and since the puncture ablation part of the ablation probe 40 is usually the central position of the tissue 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, the temperature probe 51 can be arranged in the normal tissue at the edge of the tissue 10 to be ablated by independently arranging the temperature probe 51 and the ablation probe 40, so that on one hand, the temperature of the junction area 13 of the tissue to be ablated can be measured in real time; on the other hand, the temperature probe 51 does not directly contact the tissue 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 an ablation host 60 and a connection line 61, wherein the connection line 61 is used for connecting the ablation host 60 and the control handle 56. One end of the connecting wire 61 is respectively connected with the temperature measuring sensors in the ablation probe 40 and the temperature measuring probe 51 through different conducting wires; the other end of the connecting wire 61 is connected with a temperature monitoring module 64 in the ablation host 60. In addition, the connecting line 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 refrigerant liquid inlet pipeline 45 is connected with a refrigerant storage bottle 67 for providing refrigerant; preferably, another refrigerant storage bottle is connected to the end of the refrigerant connection line communicating with the refrigerant return line 46 for storing the circulated refrigerant. A control valve 66 is provided on the refrigerant circulation line.
The ablation host 60 includes a control module 62, an ablation module 63, and a temperature monitoring module 64. The control module 62 is connected with the temperature monitoring module 63 and the ablation module 64 respectively. The control valve 66 on the refrigerating fluid circulating pipeline is connected with the ablation module 63, and the first temperature sensor 52, the second temperature sensor 41 and the third temperature sensor 42 are respectively connected with the temperature monitoring module 64.
Preferably, the connection line 61 is a connection line integrated by a plurality of wires and a plurality of coolant connection pipelines, and the connection between the ablation host 60 and the ablation catheter can be realized by inserting both ends of the connection line 61 into the corresponding positions of the control handle 56 and the ablation host 60, respectively.
The ablation module 63 is used to control the ablation probe 40 to deliver cryogenic energy to the tissue 10 to be ablated. The temperature monitoring module 64 is used for measuring the temperature of the junction area 16 of the tissue to be ablated 10 and the normal tissue 15 through the first temperature measuring sensor 52, measuring the liquid inlet temperature of the refrigerant through the second temperature measuring sensor 41, and measuring the backflow temperature of the refrigerant through the third temperature measuring sensor 42.
The control module 62 is used for controlling the ablation time and power of the ablation module 63 according to the real-time temperature value collected by the temperature monitoring module 64, so as to achieve the purpose of accurate ablation. Wherein, when the temperature around the temperature 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, the tissue 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, the control 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 first temperature measurement sensor 52; the control 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 the second 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 the second 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.
CN202010399304.5A 2020-05-12 2020-05-12 Ablation catheter and ablation device for image-guided ablation Pending CN111658125A (en)

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Application publication date: 20200915