Radio frequency ablation deviceTechnical Field
The present invention relates generally to the field of ablation devices, and more particularly to a radio frequency ablation device.
Background
The tissue ablation is to make local tissue cells to produce coagulation necrosis, dehydration necrosis or carbonization by a physical or chemical method, so as to achieve the aim of destroying pathological tissues.
The physical ablation method mainly comprises radio frequency ablation, microwave ablation, cryoablation and laser ablation, and the chemical ablation mainly comprises ethanol ablation and acetic acid ablation. Wherein, the radio frequency ablation is to use the heat generated by high frequency current to raise the local tissue temperature, thereby causing the coagulation necrosis of the tissue. Is commonly used for treating arrhythmia, liver tumor, kidney tumor and the like.
The radio frequency ablation needs to make the catheter go deep into the vein with the help of the angiography machine, so that the catheter is important to sense the working area under the conditions of movement and working, and the sensor is needed to assist in knowing the environmental parameters such as the temperature sensor, whereas the conventional temperature sensor is only uniformly distributed on the periphery of the catheter and is affected by the size, so that the distance between part of the temperature sensor and the radio frequency electrode is too short, and the part of the temperature sensor cannot accurately sense the environmental temperature.
The inventors believe that the environmental data of the catheter also needs to be more accurate for radio frequency operation.
Disclosure of Invention
In view of the above-described problems with the prior art, the present invention provides a radio frequency ablation device comprising an elongated body having an electrode assembly and a plurality of sets of thermocouples disposed thereon, characterized in that,
The tail end of the slender main body is a plane, a groove is formed in the middle of the tail end of the slender main body, the plurality of groups of thermocouples comprise tail end temperature sensing parts, and the tail end temperature sensing parts are arranged on the bottom wall of the groove;
the electrode assembly includes a tip electrode portion disposed on a plane of a tip of the elongated body and located on a peripheral side of a tip temperature sensing portion, the tip electrode portion being thermally insulated from the tip temperature sensing portion;
a peripheral transition ramp for connecting the bottom of the groove and the elongated body is arranged between adjacent electrodes of the terminal electrode part;
the plurality of groups of thermocouples also comprise a first annular temperature sensing part, wherein the first annular temperature sensing part is positioned on the peripheral side of the slender main body and is positioned at the joint of each transition ramp and the peripheral side of the slender main body;
A conductor is disposed within the elongate body and coupled to the electrode assembly for delivering energy to the electrode assembly to cause trauma to the tissue surface. The temperature measuring device has the technical characteristics that the tail end temperature sensing part is positioned at the bottom wall of the groove, forms a fall with the tail end electrode part, is far away from the tail end electrode part in a physical range, reduces the influence of most of the tail end electrode part caused directly, indirectly ensures the temperature measuring accuracy of the area in front of the tail end temperature sensing part, and because the tail end electrode part works to generate a thermal effect, the temperature of surrounding blood rises to drive the blood flow speed to accelerate the blood flow speed on an excessive ramp, and the first annular temperature sensing part is positioned at the tail end of the excessive ramp, so that the peripheral blood environment is frequently contacted with the first annular temperature sensing part, the temperature measuring accuracy of the first annular temperature sensing part is indirectly improved, thereby helping staff to master the temperature change of the ablation operation accuracy through the environmental temperatures of different areas, ensuring the safety of the ablation operation, and the tail end temperature sensing part and the first annular temperature sensing part are effectively far away from a heat source through physical means, and the temperature sensing accuracy is also improved.
In some embodiments, the plurality of sets of thermocouples further includes a second annular temperature sensing portion spaced from the first annular temperature sensing portion and located on a side of the first annular temperature sensing portion facing away from the distal end of the elongated body. Thus, the second annular temperature sensing part is spaced from the first annular temperature sensing part, so that the temperature sensing change in different areas of the elongated body, the radiation range of heat radiation and the temperature change speed can be known.
In some embodiments, thermocouples of the second annular temperature sensing portion are staggered from thermocouple circumferential positions of the first annular temperature sensing portion. Therefore, in the process of moving the slender body in the blood vessel, the staggered thermocouples are beneficial to monitoring the blood temperature of multiple areas, so that the range and the accuracy of the monitoring environment are improved.
In some embodiments, the electrode assembly further comprises a first annular electrode portion, the end plane of the elongated body and the peripheral side are connected excessively by an arc, the first annular electrode portion is distributed at intervals in an arc transition region, and each electrode is disposed perpendicularly to the plane of the fixing region. Therefore, the first annular electrode part increases the heat radiation area, the working range can be adjusted according to the actual area of the abnormal object point of the patient, and the first annular electrode part is positioned in the arc transition area and can also point according to the position of the first annular electrode part, so that the rotation or displacement operation on the slender main body can be reduced.
In some embodiments, the electrode assembly further comprises a second annular electrode portion distributed around the circumference of the elongate body and proximate to the end region of the elongate body. Therefore, due to the fact that the positions of the ectopic nodes of the patients are different, the limitation on the operation of the tail end of the slender main body is received, the second annular electrode part can conduct heat radiation ablation in a targeted mode, and the limitation in the use process of the slender main body is reduced.
In some embodiments, the conductors are groups of individual conductors and are connected to the tip electrode portion, the first ring electrode portion, and the second ring electrode portion, respectively. Therefore, according to the position relation between the slender main body and the ectopic site, the electrodes in the three areas can be reasonably controlled in energy, so that on one hand, the accuracy of ablation is improved, and on the other hand, the limitation in the operation process of the slender main body is reduced.
In some embodiments, the circumferential side of each thermocouple is coated with a thermally insulating layer, and the end of each thermocouple is provided with a flange member secured to the elongate body relative to the thermally insulating layer.
In some embodiments, a flushing channel is also provided in the elongate body, the end of the flushing channel being provided with at least one outlet opening onto the transition ramp bottom wall. Therefore, in the process of radio frequency ablation, a large amount of heat can be generated, the introduced cooling liquid directly acts on the radio frequency area, the excessive damage to surrounding normal tissues caused by overhigh local temperature is reduced, the outlet is positioned on the bottom wall of the transition ramp, not only is the electrode area close to the outlet, but also the separation effect between the tail end temperature sensing part and the tail end electrode part is achieved, the accuracy of the tail end temperature sensing part to the peripheral temperature sensing environment is ensured, in addition, the flowing cooling liquid directly contacts with the blood on the transition ramp, along with the introduction of the cooling liquid, the flowing efficiency of the blood on the peripheral side of the outlet is also accelerated, the contact frequency of the blood in different areas and the first annular temperature sensing part is indirectly enlarged, and the measuring accuracy is improved.
In some embodiments, the elongate body has a plurality of peripheral side thermally conductive members disposed thereon and thermally coupled to the tip electrode portion, the first annular electrode portion, and the second annular electrode portion;
The elongated body is further provided with a plurality of deep heat conducting members thermally connected to the plurality of peripheral heat conducting members and extending in a direction away from the distal end of the elongated body. Therefore, the peripheral side heat conducting piece can disperse the electrode heat of the annular area, and the deep heat conducting piece can transfer the heat accumulated on the peripheral side heat conducting piece to a concentrated area far away from the heat, so that the self heat of the slender main body is dispersed more, the influence of overhigh self temperature on surrounding healthy tissues is reduced.
In some embodiments, an annular flow guiding cavity is arranged in the slender main body, and the flow guiding cavity is thermally connected with the deep heat conducting piece;
and a liquid inlet pipe communicated with the flow guide cavity and a liquid outlet pipe communicated with the flow guide cavity are arranged in the slender main body. Therefore, a circulating cooling channel is formed in the slender main body, heat carried on the deep heat conducting piece is transferred to the outside of the body, the flow guide cavity is annular, connection of a circuit is not hindered, the flow guide cavity is an annular area close to the periphery of the slender main body, the heat transfer effect on the periphery of the slender main body is achieved, and the cooling effect is achieved in the slender main body.
It should be understood that what is described in this summary is not intended to limit the critical or essential features of the embodiments of the disclosure nor to limit the scope of the disclosure. Other features of the present disclosure will become apparent from the following description.
Drawings
Fig. 1 is a schematic diagram showing the overall structure of a radio frequency ablation device according to an embodiment of the present invention;
fig. 2 is a schematic perspective view of an end portion of an elongated body of a radiofrequency ablation device according to an embodiment of the present invention;
fig. 3 is a schematic diagram showing an end face structure of an actuator in a radio frequency ablation device according to an embodiment of the present invention;
FIG. 4 illustrates a partial cross-sectional view of an elongate body of a radiofrequency ablation device provided by an embodiment of the present invention;
fig. 5 shows a cross-sectional view of a thermocouple heat insulation structure of a radiofrequency ablation device according to an embodiment of the present invention.
Symbol description
1. The device comprises an elongated main body, 11, an executing part, 111, a groove, 112, an excessive ramp, 12, a conveying part, 2, a handle, 21, an interface, 3, a liquid supply device, 4, an electrode assembly, 41, a tail end electrode part, 42, a first annular electrode part, 43, a second annular electrode part, 5, a plurality of groups of thermocouples, 51, a tail end temperature sensing part, 52, a first annular temperature sensing part, 53, a second annular temperature sensing part, 61, a flushing channel, 62, an outlet, 71, a peripheral side heat conducting piece, 72, a longitudinal heat conducting piece, 81, a diversion cavity, 82, a liquid inlet pipe, 83, a liquid outlet pipe, 91, a heat insulation layer, 92 and a flange piece.
Detailed Description
Hereinafter, preferred embodiments (or implementations) of the present invention will be described in detail with reference to the accompanying drawings.
A radiofrequency ablation device of the present invention is described with reference to fig. 1-5.
Fig. 1 shows a schematic overall structure of a radio frequency ablation device according to an embodiment of the present invention. Referring to fig. 1, the radio frequency ablation device provided in this embodiment includes an elongated body 1, and a handle 2 connected to the elongated body 1, where a liquid supply device 3 is disposed at the tail of the handle 2 and partially connected to the elongated body 1. The long and thin main body 1 can be a catheter and comprises a distal execution part 11 and a conveying part 12 positioned at the tail part of the execution part 11, the handle 2 is positioned at the tail end of the conveying part 12, and the handle 2 can control the catheter to extend into a vein and convey the execution part 11 to an area in the body to be ablated for operation. The liquid supply device 3 comprises an internal environment cooling mechanism and an external environment cooling mechanism, which are provided with independent containers, independent pump bodies and independent cooling liquid, and the cooling liquid is introduced into the slender main body 1 through the interface 21, so that the cooling of the internal part of the slender main body 1 and the external environment where the end part of the slender main body 1 is positioned is realized. While the elongate body 1 is mainly to a catheter.
Fig. 2 shows a schematic perspective view of an end portion of an elongated body 1 of a radio frequency ablation device according to an embodiment of the present invention. Referring to fig. 2, an electrode assembly 4 and a plurality of sets of thermocouples 5 are provided on an actuating portion 11 of the elongated body 1. Wherein the electrode assembly 4 comprises a tip electrode portion 41, a first annular electrode portion 42 and a second annular electrode portion 43, and the plurality of sets of thermocouples 5 comprises a tip temperature sensing portion 51, a first annular temperature sensing portion 52 and a second annular temperature sensing portion 53.
Fig. 3 is a schematic diagram showing an end face structure of an executing portion 11 in a radio frequency ablation device according to an embodiment of the present invention. Referring to fig. 2 and 3, the end of the elongated body 1 is flat, and a central region thereof is depressed to form a groove 111, and the groove 111 may be a circular region so that sides of the groove 111 are more uniformly spaced from the end edge of the actuator 11. The end temperature sensing portion 51 is fixed on the bottom surface of the groove 111, and the end temperature sensing portion 51 includes at least one thermocouple, and is uniformly distributed on the bottom of the groove 111 in a ring shape, and the thermocouple of the end temperature sensing portion 51 in this embodiment is taken as an example and is located in the central area of the groove 111.
The end electrode portion 41 is fixed on the end face of the actuator 11, and the end electrode portion 41 includes at least 3 rf electrodes, which are circumferentially and equidistantly distributed on the end face of the actuator 11 around the groove 111 in the middle, in this embodiment, 4 rf electrodes are taken as an example. In some embodiments, the axis of the rf electrode in each of the tip electrode portions 41 is perpendicular to the fixed plane so that the resulting rf range is more dispersed. In some embodiments, the axis of the rf electrode in each of the end electrode portions 41 is directed to a common point of action, which is located on an extension of the centerline of the actuator 11, so that the radiation range of the end electrode portions 41 is more concentrated and the effect is more efficient when the end electrode portions 41 are operated at rf frequencies.
Because the end face of the executing part 11 and the groove 111 form a height difference, the terminal temperature sensing part 51 avoids direct radiation of most of the terminal electrode parts 41 in physical aspects, so that the temperature sensing area of the terminal temperature sensing part 51 is closer to the area of the end part of the executing part 11, and the accuracy of detecting the temperature of the terminal temperature sensing part 51 is improved.
Wherein, an excessive ramp 112 is disposed between two adjacent rf electrodes in the terminal electrode portion 41, one end of the excessive ramp 112 is engaged with the groove 111, and the other end is engaged with the peripheral side of the actuator 11. The first annular temperature sensing portion 52 is provided on the peripheral side of the actuator 11 and is located in an annular region engaged with the transition ramp 112. The first annular temperature sensing portion 52 includes a plurality of thermocouples, and the thermocouples are fixed at junctions of each transition ramp 112 with the peripheral side of the execution portion 11, and at least one junction is provided at each junction. On one hand, the first annular temperature sensing part 52 and the tail end temperature sensing part 51 form a height difference, the temperature measuring area is increased, the influence of high temperature caused by the radio frequency electrode is avoided, the temperature change of different areas and the speed of temperature conduction are also fed back, and on the other hand, when the radio frequency electrode works at radio frequency, the temperature of peripheral blood is increased, so that the flow efficiency of the blood is increased, the blood flow space provided by the transition ramp 112 also increases the contact frequency of the blood and the thermocouple of the first annular temperature sensing part 52, and the accuracy of temperature measurement of the first annular temperature sensing part 52 is indirectly improved.
The second annular temperature sensing portion 53 and the first annular temperature sensing portion 52 are arranged at intervals and are located on one side, away from the tail end temperature sensing portion 51, of the first annular temperature sensing portion 52, the second annular temperature sensing portion 53 comprises a plurality of thermocouples which are fixed on the peripheral side of the executing portion 11 and are distributed at equal intervals, the thermocouples of the second annular temperature sensing portion 53 are staggered with the peripheral positions of the thermocouples of the first annular temperature sensing portion 52, a temperature measuring area is increased, meanwhile, a blood flowing path is considered, the ambient temperature on the peripheral side of the executing portion 11 is controlled more comprehensively, and when ablation operation is facilitated, the ambient temperature change on the peripheral side of the executing portion 11 is mastered in real time, so that the safety of the ablation operation is improved.
The end of the executing portion 11 is excessively connected with the peripheral side through an arc, and the first annular electrode portion 42 includes a plurality of groups of radio frequency electrodes, each group of radio frequency electrodes is at least provided with 2 radio frequency electrodes, and is uniformly distributed in the arc transition area in circumference, and the axis of each radio frequency electrode is mutually perpendicular to the arc fixing area, so that the breadth of the whole radio frequency range is increased, and the range of the whole radio frequency range is increased in cooperation with the co-operation of the end electrode portion 41.
The second annular electrode portion 43 is located on the peripheral side of the actuator 11 and is disposed near the end of the actuator 11, and the second annular electrode portion 43 includes a plurality of rf electrodes and is circumferentially equally distributed on the peripheral side region of the actuator 11. And the tail end electrode part 41, the first annular electrode part 42 and the second annular electrode part 43 are all provided with energy by independent conductors, so that various combined energy supplies can be carried out according to different conditions of the ablation operation, the operation blind spot of movement or rotation of the slender main body 1 is avoided, and the effectiveness of the ablation operation is ensured.
Fig. 4 shows a partial cross-sectional view of an elongate body 1 of a radiofrequency ablation device provided by an embodiment of the invention. Referring to fig. 4, during the ablation operation, a great amount of heat is generated by the operation of the rf electrode at the end of the actuator 11, and if the heat is accumulated for a long time, the actuator 11 is damaged, the accuracy of monitoring the temperature by the plurality of sets of thermocouples 5 is affected, and the tissue in the healthy area in the body is wounded. The inside of the elongated body 1 is further provided with a flushing channel 61, the flushing channel 61 being arranged inside the elongated body 1 along the length direction of the elongated body 1, one end of the flushing channel 61 extending into the handle 2 and being interconnected with an external environment cooling mechanism, and the other end extending to the end of the actuator 11 being distributed with a plurality of outlets 62 and opening on the bottom wall of each transition ramp 112. The cooling liquid used in the external environment cooling mechanism may be low-temperature blood or cold brine, and along with the ablation operation, the cooling liquid is supplied into the elongated body 1 through the pump body of the external environment cooling mechanism so as to reduce the temperature of the peripheral side area of the execution part 11, and the orientation of each outlet 62 is mutually perpendicular to the bottom wall of the transition ramp 112, so that the cooling liquid is distributed more widely, and the cooling liquid can be applied to the simultaneous operation of the tail end electrode part 41, the first annular electrode part 42 and the second annular electrode part 43. In addition, in the process of discharging the cooling liquid, the tail end electrode part 41 and the tail end temperature sensing part 51 are separated, so that the temperature sensing space of the tail end electrode part 41 is more independent, the accuracy of the tail end temperature sensing part 51 to the peripheral side temperature sensing environment is ensured, the flowing cooling liquid is in direct contact with the blood on the transition ramp 112, the flowing efficiency of the blood on the peripheral side of the outlet 62 is accelerated along with the introduction of the cooling liquid, the contact frequency of the blood in different areas and the first annular temperature sensing part 52 is indirectly enlarged, and the measuring accuracy is improved.
Referring to fig. 3 and 4, during the ablation operation, the rf electrode itself generates a large amount of heat, and if the rf electrode at high temperature contacts with healthy tissue, the tissue is easily damaged, so the surface layer of the executing portion 11 is further provided with a heat conducting member assembly for dispersing the heat of the rf electrode. Wherein the heat conductive member assembly includes a peripheral side heat conductive member 71 and a deep heat conductive member 72. The peripheral side heat conductive member 71 is provided in plurality and located at the fixing areas of the tip electrode portion 41, the first ring electrode portion 42, and the second ring electrode portion 43 and thermally connects the surrounding rf electrodes to each other, and the deep heat conductive member 72 is fixed on the outer peripheral surface of the actuator 11 at intervals and thermally connected to the peripheral side heat conductive members 71 of a plurality of paths. The heat conducting component is mainly made of diamond, the heat conductivity of the heat conducting component is about 2000-2200W/m and K is 5 times that of copper, and the generated heat can be efficiently conducted. When the rf electrode is operated, its own heat is transferred to the peripheral side heat conductive member 71 and is uniformly concentrated on the deep heat conductive member 72, so that most of the heat is transferred in a direction away from the end of the actuator 11.
Referring to fig. 4, an internal circulation cooling channel is further provided in the elongated main body 1, the internal circulation cooling channel includes an annular diversion cavity 81, a liquid inlet pipe 82 and a liquid outlet pipe 83 which are mutually communicated with the diversion cavity 81, and the liquid inlet pipe 82 and the liquid outlet pipe 83 are both located in the elongated main body 1 and extend towards the direction of the handle 2, and finally are mutually connected with an internal environment cooling mechanism. The flow guiding cavity 81 is located at the end of the deep heat conducting members 72 and is thermally connected to the end of each deep heat conducting member 72, and the internal environment cooling mechanism provides flowing cooling liquid to the inside of the elongated body 1 during the blending operation, and the cooling liquid can transfer the heat accumulated on the deep heat conducting members 72 out of the elongated body 1, so that the accumulation of most of the heat on the radio frequency electrode is reduced. The annular flow guide cavity 81 can transfer heat carried by the deep heat conducting piece 72 on one hand, and is close to the outer area of the execution part 11 on the other hand, so that the whole heat dissipation of the execution part 11 is facilitated, the annular flow guide cavity is annularly distributed, the line communication of a plurality of execution part 11 pieces and sensors at the end part of the execution part 11 is not influenced, the temperature reduction of the long and thin main body 1 is ensured, and meanwhile, the normal and stable operation of ablation operation is ensured.
The handle 2 is also provided with a chip inside, and the chip is electrically connected with the electrode assembly 4 and the plurality of groups of thermocouples 5 at the tail end of the slender main body 1. So that temperature data measured in real time by the plurality of sets of thermocouples 5 can be transmitted into the chip. The tail end of the handle 2 is also provided with an interface 21 electrically connected with the chip, and the interface 21 is used for being connected with the radio frequency signal generator and the PC end. The radiofrequency signal generator can emit radiofrequency signals to the electrode assembly 4, so that the tail end of the slender main body 1 can perform ablation operation, and the combined operation of the tail end electrode part 41, the first annular electrode part 42 and the second annular electrode part 43 can be freely allocated, so that different ablation working conditions can be adapted. The temperature data transmitted by the plurality of groups of thermocouples 5 in real time can be displayed and stored at the computer end so as to monitor physical signs in cooperation with ablation operation.
Fig. 5 shows a cross-sectional view of a thermocouple heat insulation structure of a radio frequency ablation device according to an embodiment of the present invention, and referring to fig. 5, each thermocouple in the plurality of groups of thermocouples 5 is heat-insulated, a tubular heat insulation layer 91 is wrapped around each thermocouple, the heat insulation layer 91 may be made of aerogel material or aluminum foil material, and in order to increase stability of fixing the thermocouple with the executing portion 11, a flange member 92 is disposed at an end portion of the thermocouple, a diameter of a central region of the flange member 92 is greater than a diameter of the thermocouple, an oblique incision is formed in a central annular region of the thermocouple, and the thermocouple is fixed in a designated region of the executing portion 11 by fixing the flange member 92 with an end portion of the executing portion 11, and the thermocouple and an inner wall of the flange member 92 are not in contact with each other, so as to avoid direct heat transfer.
The tip of the actuator 11 further comprises a contact sensing subsystem comprising a signal source and a processing device, the processing device being integrated inside the chip, the signal source being configured to deliver a range of frequencies to the electrode assembly 4, the processing device being configured to obtain impedance measurements when different frequencies within the range of frequencies are applied to the electrode assembly 4 by the signal source, to process the impedance measurements obtained at the different frequencies, and to determine whether the electrode assembly 4 is in contact with tissue based on the processing of the impedance measurements.
In the description of the present specification, the terms "connected," "mounted," "fixed," and the like are to be construed broadly, and "connected" may be, for example, a fixed connection, a detachable connection, or an integral connection, and may be directly connected or indirectly connected through an intermediary. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.
The above is only a preferred embodiment of the present application, and is not intended to limit the present application, but various modifications and variations can be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.