WO2022091369A1 - Système d'ablation - Google Patents

Système d'ablation Download PDF

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Publication number
WO2022091369A1
WO2022091369A1 PCT/JP2020/040904 JP2020040904W WO2022091369A1 WO 2022091369 A1 WO2022091369 A1 WO 2022091369A1 JP 2020040904 W JP2020040904 W JP 2020040904W WO 2022091369 A1 WO2022091369 A1 WO 2022091369A1
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WIPO (PCT)
Prior art keywords
ablation
value
control unit
power supply
electrode needle
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PCT/JP2020/040904
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English (en)
Japanese (ja)
Inventor
久生 宮本
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日本ライフライン株式会社
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Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to PCT/JP2020/040904 priority Critical patent/WO2022091369A1/fr
Priority to JP2022558772A priority patent/JPWO2022091369A1/ja
Publication of WO2022091369A1 publication Critical patent/WO2022091369A1/fr

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    • 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

Definitions

  • the present invention relates to an ablation system including an electrode needle that is percutaneously punctured into an affected area in the body and a power supply device that supplies electric power for ablation (causing).
  • an ablation system that ablate the affected area has been proposed (for example, Patent Document 1). reference).
  • This ablation system includes an electrode needle that is percutaneously punctured into the affected area in the body, and a power supply device that supplies electric power to perform ablation on the affected area.
  • the ablation system is a power source that supplies electric power for ablation between an electrode needle that is percutaneously punctured into an affected portion in the body and the electrode needle and the counter electrode plate. It is provided with a power supply device including a unit, a control unit that controls a power supply operation in the power supply unit, and a control unit. Information indicating the measured temperature near the tip of the electrode needle is supplied from the electrode needle to the control unit. Further, the control unit sets a predetermined condition that the measured temperature changes by a decrease amount of the first threshold value or more when the control unit controls to increase or maintain the power supply value at the time of ablation. If it is satisfied, at least one of a first process of reducing or stopping the power supply and a second process of outputting a predetermined notification to the outside of the power supply device is executed.
  • the above-mentioned description is made.
  • At least one of the first process and the second process is executed.
  • the electrode There may be signs of a so-called steam pop phenomenon (popping phenomenon, pop phenomenon) near the ablation site (for example, the affected area to be ablated) by the needle.
  • the control unit measures the impedance value between the electrode needle and the counter electrode plate, and when the predetermined conditions are satisfied, the control unit measures the impedance value.
  • the fluctuation value per unit time in the impedance value indicates an increase of the second threshold value or more
  • the first process and the second process are not executed, respectively, while the unit in the impedance value.
  • the fluctuation value per hour indicates an increase below the second threshold value or a decrease
  • at least one of the first process and the second process is to be executed. You may do it.
  • the above-mentioned first item depends on the magnitude of the fluctuation value per unit time in the impedance value and whether the change is an increase or a decrease. It may be decided whether or not the process and the second process are executed. In this case, the sign of the steam pop phenomenon can be detected more accurately by using the parameter of the fluctuation value per unit time in the impedance value. Specifically, it becomes possible to detect, for example, a situation in which the electrode needle is moving along the anteroposterior direction near the cautery site, rather than showing signs of a steam pop phenomenon.
  • control unit measures the impedance value between the electrode needle and the counter electrode plate, and when the above-mentioned predetermined conditions are satisfied and the above-mentioned measurement temperature is lowered, the above-mentioned As the impedance value rises, the impedance value decreases when the measured temperature rises, and the measured temperature and the impedance value fluctuate in opposite directions along the time axis.
  • the first process and the second process are prevented from being executed, respectively, and when the measured temperature and the impedance value do not fluctuate in opposite directions along the time axis, the first process is performed.
  • One process and at least one of the second processes may be executed.
  • the movement of the electrode needle near the ablation site as described above can be detected more accurately by utilizing the presence or absence of fluctuations in the opposite direction between the measured temperature and the impedance value described above. It will be like.
  • the signs of the steam pop phenomenon can be detected more accurately, and as a result, the above-mentioned decrease in ablation efficiency can be easily prevented, and the above-mentioned burden on the patient's body can be easily reduced.
  • the control unit alternately repeats fluctuations in opposite directions between the measured temperature and the impedance value in a predetermined cycle when the predetermined conditions are satisfied.
  • the first process and the second process may not be executed respectively.
  • the state in which the electrode needle is moving near the ablation site can be detected more accurately, and the signs of the steam pop phenomenon can be detected even more accurately.
  • the above-mentioned decrease in ablation efficiency can be further prevented.
  • the burden on the patient's body as described above can be further reduced.
  • control unit may raise or maintain the power supply value in a line shape or a step shape along the time axis, for example.
  • control unit may, for example, maintain the power supply value along the time axis (at an arbitrary fixed value).
  • the ablation system when the above-mentioned predetermined conditions are satisfied at the time of ablation, at least one of the above-mentioned first process and second process is executed. So, it will be as follows. That is, it becomes possible to execute the processing for detecting the sign of the steam pop phenomenon in advance and the processing for dealing with the detection of such a sign. Therefore, it is possible to reduce the burden on the patient's body during ablation.
  • FIG. 1 is a schematic block diagram showing an overall configuration example of an ablation system (ablation system 5) according to an embodiment of the present invention.
  • This ablation system 5 for example, as shown in FIG. 1, is a system used when treating an affected portion 90 in the body of a patient 9, and a predetermined ablation is performed on such an affected portion 90.
  • the affected area 90 include an affected area having a tumor such as cancer (liver cancer, lung cancer, breast cancer, kidney cancer, thyroid cancer, etc.).
  • the ablation system 5 includes an electrode needle 1, a liquid supply device 2, and a power supply device 3. Further, in the ablation using the ablation system 5, for example, the counter electrode plate 4 shown in FIG. 1 is also appropriately used.
  • the electrode needle 1 is, for example, as shown by the arrow P1 in FIG. 1, a needle that is percutaneously punctured into the affected portion 90 in the body of the patient 9.
  • the electrode needle 1 is used during the above-mentioned ablation, and has an electrode portion 11 and a covering portion 12 as shown in FIG. 1, for example.
  • the liquid L supplied from the liquid supply device 2 described later circulates and flows inside the electrode needle 1 (see FIG. 1).
  • the electrode portion 11 is a region portion of the needle-shaped structure constituting the electrode needle 1 that is not covered with an insulating coating, and is a portion that functions as an electrode during ablation.
  • the covering portion 12 is a region portion of the above-mentioned needle-shaped structure in which an insulating coating is made. As shown in FIG. 1, the electrode portion 11 is arranged near the tip of the electrode needle 1, and the covering portion 12 is arranged on the proximal end side of the electrode portion 11.
  • the liquid supply device 2 is a device that supplies the cooling liquid L to the electrode needle 1 described above, and has, for example, a liquid supply unit 21 as shown in FIG.
  • Examples of the cooling liquid L include sterilized water and sterilized physiological saline.
  • the liquid supply unit 21 supplies the above-mentioned liquid L to the electrode needle 1 at any time according to the control by the control signal CTL2 described later. Specifically, for example, as shown in FIG. 1, the liquid supply unit 21 causes the liquid L to circulate between the inside of the liquid supply device 2 and the inside of the electrode needle 1 (in a predetermined flow path). Then, the liquid L is supplied. Further, although the details will be described later, such a liquid L supply operation is executed or stopped according to the control by the control signal CTL2 described above.
  • the liquid supply unit 21 is configured to include, for example, a liquid pump or the like.
  • the power supply device 3 supplies a power Pout (for example, radio frequency (RF) power) for ablation between the electrode needle 1 and the counter electrode plate 4, and also supplies the liquid L in the liquid supply device 2 described above. It is a device that controls the supply operation. As shown in FIG. 1, the power supply device 3 has an input unit 31, a power supply unit 32, a control unit 33, and a display unit 34.
  • RF radio frequency
  • the input unit 31 is a part for inputting various set values and an instruction signal (operation signal Sm) for instructing a predetermined operation described later.
  • Such an operation signal Sm is input from the input unit 31 in response to an operation by an operator (for example, an engineer or the like) of the power supply device 3.
  • these various setting values are not input according to the operation by the operator, but may be set in advance in the power supply device 3 at the time of shipment of the product, for example.
  • the set value input by the input unit 31 is supplied to the control unit 33, which will be described later.
  • such an input unit 31 is configured by using, for example, a predetermined dial, button, touch panel, or the like.
  • the power supply unit 32 is a portion that supplies the above-mentioned power Pout between the electrode needle 1 and the counter electrode plate 4 according to the control signal CTL1 described later.
  • a power supply unit 32 is configured by using a predetermined power supply circuit (for example, a switching regulator or the like).
  • the frequency is, for example, about 450 kHz to 550 kHz (for example, 500 kHz).
  • the control unit 33 is a part that controls the entire power supply device 3 and performs predetermined arithmetic processing, and is configured by using, for example, a microcomputer or the like. Specifically, the control unit 33 first has a function (power supply control function) of controlling the power supply operation of the power supply unit 32 by using the control signal CTL1. Further, the control unit 33 has a function (liquid supply control function) of controlling the supply operation of the liquid L in the liquid supply device 2 (liquid supply unit 21) by using the control signal CTL 2. Further, the control unit 33 has a function (display control function) for controlling the display operation in the display unit 34, which will be described later.
  • Such a control unit 33 also has temperature information indicating the temperature measured Tm near the tip of the electrode needle 1 (a temperature sensor such as a thermoelectric pair arranged inside the electrode unit 11), for example, as shown in FIG. It is designed to be supplied at any time. Further, for example, as shown in FIG. 1, the measured value of the impedance value Z (described later) is supplied to the control unit 33 from the power supply unit 32 described above at any time.
  • control unit 33 The details of the control operation and the like in the control unit 33 including the above-mentioned power supply control function and liquid supply control function will be described later.
  • the display unit 34 is a part (monitor) that displays various information and outputs it to the outside.
  • the information to be displayed includes, for example, the various set values input from the input unit 31 and various parameters supplied from the control unit 33 (for example, the impedance value Z described later and the count value of the number of breaks Nb). , Temperature information It supplied from the electrode needle 1 (information on the measurement temperature Tm described above) and the like.
  • the information to be displayed is not limited to these information, and other information may be displayed instead or by adding other information.
  • Such a display unit 34 is configured by using a display by various methods (for example, a liquid crystal display, a CRT (Cathode Ray Tube) display, an organic EL (Electro Luminescence) display, or the like).
  • the counter electrode plate 4 is used in a state of being attached to the body surface of the patient 9 at the time of ablation.
  • high frequency energization power Pout is supplied
  • the impedance value Z between the electrode needle 1 (electrode portion 11) and the counter electrode plate 4 is measured and measured at any time.
  • the impedance value Z is supplied from the power supply unit 32 to the control unit 33 in the power supply device 3.
  • the liquid supply device 2 (so that the cooling liquid L circulates between the inside of the liquid supply device 2 and the inside of the electrode needle 1 (in a predetermined flow path)).
  • the liquid L is supplied from the liquid supply unit 21) to the electrode needle 1 (see FIG. 1).
  • a cooling operation (cooling) is performed on the electrode needle 1.
  • the tissue temperature of the affected area 90 rises sufficiently based on the temperature information It indicating the measured temperature Tm near the tip of the electrode needle 1.
  • the condition of cauterization of the affected area is confirmed, such as whether it is present.
  • FIG. 2 schematically shows an example of the cauterization condition in the affected area 90 due to such ablation.
  • the initial rugby ball-shaped (elliptical spherical) thermal coagulation region Ah1 gradually expands.
  • a substantially spherical thermal coagulation region Ah2 is obtained (see the broken line arrow in FIG. 2).
  • isotropic ablation of the entire affected area 90 is performed, and as a result, effective treatment of the affected area 90 is performed.
  • FIG. 3 schematically shows an example of the break state and the number of breaks at the time of ablation in a timing diagram. Specifically, in FIG. 3, an example of a measured waveform of the impedance value Z between the electrode needle 1 (electrode portion 11) and the counter electrode plate 4 is shown along the time axis.
  • the ablation is first started, and when the tissue of the affected area 90 is cauterized and the temperature rises, the impedance value Z decreases. To go. This is because the temperature of water that contributes to electrical conduction rises in this tissue, and the thermal motion of water ions becomes active, so that the electrical conductivity in the tissue improves and the impedance value Z decreases. It has become like. Then, as the ablation progresses, the water content in the tissue of the affected area 90 evaporates, and conversely, the impedance value Z rises sharply.
  • Such a rapid increase in the impedance value Z is an index of thermal coagulation of the tissue in the affected area 90, and thus serves as a guideline for the stop timing during ablation.
  • a state in which the impedance value Z exceeds a predetermined threshold value Zth (Z> Zth) is called a “break state” (see FIG. 3).
  • ablation supply of electric power Pout
  • ablation is temporarily stopped, and then ablation is restarted.
  • water is supplied from the surrounding tissue into the tissue in the affected area 90, and as a result, the impedance value Z is lowered again for the above reason (see FIG. 3).
  • the temporary stop time of ablation (waiting time until restart of ablation) is, for example, a preset predetermined time (for example, about 10 seconds to 15 seconds) or before the impedance value Z rises. The time it takes to return to the value of.
  • Various information such as the count value of the number of breaks Nb is displayed at any time on the display unit 34 of the power supply device 3, as shown schematically in FIG. 4, for example.
  • the display unit 34 first, as schematically shown in FIG. 3 described above, the measured waveform of the impedance value Z is displayed along the time axis (reference numeral in FIG. 4). See page 20). Further, in the example of the display unit 34, the current value of the impedance value Z (Impedance: see the reference numeral P21), the temperature information It (Temperature: see the reference numeral P22) indicating the measurement temperature Tm described above, and the supply value of the power Pout.
  • the ablation is terminated as follows. Specifically, first, the operator of the power supply device 3 visually confirms the number of breaks Nb (for example, about 2 to 3 times as described above), and then manually terminates the ablation (comparative example). 1) can be mentioned.
  • Another method (Comparative Example 2) is to automatically stop the supply of power Pout after a predetermined standby time (fixed value) has elapsed without checking the number of breaks Nb. Will be.
  • this pain means the pain felt by the patient 9 during treatment, and it is said that, for example, the right shoulder and the like often hurt as referred pain via the spinal nerve. Since the impedance value Z rises sharply in the break state, the output voltage also rises sharply when the power Pout is output as a constant power, for example. In addition, the temperature at the affected area 90 tends to rise before the transition to the break state. Therefore, it is said that this pain has both electrical and thermal causes.
  • liver cancer generally has a higher recurrence rate than cancer in other organs, so that repeated treatment is required, but the memory of pain felt by patient 9 prevents the patient from receiving the next treatment. There is a risk of becoming.
  • strengthening the anesthesia during treatment can reduce such pain, strengthening the anesthesia hinders the prediction of complications. Based on these facts, it is ideal to minimize pain while using the minimum amount of anesthesia. Therefore, the number of breaks Nb during treatment by ablation is also the same as in Comparative Examples 1 and 2 above. Moreover, it is not desirable to have more than necessary.
  • FIG. 5 is a flow chart showing an example of ablation processing in the ablation system 5 of the present embodiment.
  • the threshold value Zth (threshold value of the impedance value Z) described above and the threshold value Nth (threshold value of the number of breaks Nb) described later are set (step S10 in FIG. 5). Further, in this step S10, the threshold value ⁇ Pth (threshold value of the power increase value ⁇ P described later) and the threshold value ⁇ Tmth (threshold value of the change amount ⁇ Tm of the measured temperature Tm described later), which will be described later with reference to FIG. 7, are also set. Is supposed to be done. Specifically, the set values of these threshold values Zth, Nth, ⁇ Pth, and ⁇ Tmth are input from the input unit 31 according to the operation by the operator of the power supply device 3, and are supplied to the control unit 33.
  • the above-mentioned threshold value ⁇ Tmth corresponds to a specific example of the “first threshold value” in the present invention.
  • the method of defining by this relative value there are a method of defining the impedance value Z at the start of ablation as a reference and a method of defining the minimum value of the impedance value Z after the start of ablation as a reference.
  • the setting values of such various parameters are not input according to the operation by the operator, but are set in advance in the power supply device 3, for example, at the time of shipment of the product. You may do so.
  • ablation with respect to the affected portion 90 is started by supplying a power Pout from the power supply device 3 (power supply unit 32) between the electrode needle 1 and the counter electrode plate 4 (step S11). Specifically, the start of this ablation is executed by inputting the operation signal Sm from the input unit 31 and supplying it to the control unit 33 in response to the operation by the operator of the power supply device 3. That is, in this example, the ablation is manually initiated.
  • the power supply unit 32 first measures the impedance value Z between the electrode needle 1 and the counter electrode plate 4 (step S12). In other words, the control unit 33 acquires the measurement information of such an impedance value Z. Then, when the impedance value Z measured in this way is supplied from the power supply unit 32 to the control unit 33, the control unit 33 then makes the following determination. That is, the control unit 33 determines whether or not the impedance value Z is larger than the threshold value Zth set in step S10 (whether or not Z> Zth is satisfied) (step S13).
  • step S13: N if it is determined that the impedance value Z is equal to or less than the threshold value Zth (Z> Zth is not satisfied) (step S13: N), the process returns to step S12 described above, and the impedance value Z is measured again. Will be.
  • step S13 when it is determined that the impedance value Z is larger than the threshold value Zth (satisfying Z> Zth) (step S13: Y), it means that the state has shifted to the break state described above. Therefore, in this case, the control unit 33 then automatically counts the number of transitions to this break state (break count Nb) (step S14).
  • break count Nb The count value of the number of breaks Nb is stored in various storage media in the control unit 33 at any time.
  • control unit 33 temporarily stops the ablation by temporarily reducing or stopping the supply of the power Pout from the power supply unit 32 by using the control signal CTL1 described above (step S15).
  • the impedance value Z drops again, and the break state is exited.
  • control unit 33 determines whether or not the number of breaks Nb counted in step S14 is equal to or greater than the threshold value Nth set in step S10 (whether or not Nb ⁇ Nth is satisfied) (step S16). ). If it is determined that the number of breaks Nb is less than the threshold value Nth (Nb ⁇ Nth is not satisfied) (step S16: N), then the power Pout supply (ablation) is automatically or manually restarted. (Step S17).
  • FIG. 6 shows an example of the operation mode at the time of restarting the supply of such power Pout (step S17).
  • examples of the operation mode at this time include two types of operation modes, "fully automatic mode” and "semi-automatic mode”.
  • the control unit 33 automatically restarts the power Pout supply (ablation) (step S17). Specifically, the control unit 33 automatically restarts the supply of the power Pout from the power supply unit 32 by using the control signal CTL1 described above. That is, in this fully automatic mode, the supply of the power Pout is automatically restarted.
  • step S16 when the number of breaks Nb has not reached the threshold value Nth (step S16: N), the control unit 33 is based on the operation signal Sm input in response to the operation by the operator of the power supply device 3. Restarts the supply (ablation) of the power Pout (step S17). That is, in this semi-auto mode, the power supply of the power Pout is manually restarted.
  • such two types of operation modes (“full auto mode” and “semi-auto mode”) may be switchable (shown in FIG. 6). See the dashed arrow P3). That is, for example, these two types of operation modes may be switched at any time based on the operation signal Sm input in response to the operation by the operator of the power supply device 3.
  • step S15 when the supply of the electric power Pout is temporarily “decreased", the impedance value Z can be continuously measured even in the above-mentioned break state.
  • step S15 when the supply of the power Pout is temporarily “stopped", the impedance value Z is not measured when the break state is reached.
  • step S16 if it is determined that the number of breaks Nb is equal to or greater than the threshold value Nth (Satisfying Nb ⁇ Nth) (step S16: Y), then the control unit 33 performs the following control. conduct. That is, when the number of breaks Nb reaches the threshold value Nth (step S16: Y), the control unit 33 automatically stops (completely stops) the supply of the power Pout from the power supply unit 32 to automatically stop the ablation. (Step S18). Specifically, the control unit 33 automatically stops the supply of the power Pout by using the control signal CTL1 described above. As a result, the ablation for the affected area 90 is automatically terminated by the control unit 33.
  • control unit 33 automatically ends the ablation in this way (step S18), and then automatically stops the supply of the cooling liquid L from the liquid supply device 2 (step S19). .. Specifically, the control unit 33 automatically stops the supply of the liquid L from the liquid supply unit 21 by using the control signal CTL2 described above. As a result, the circulation of the liquid L between the inside of the liquid supply device 2 and the inside of the electrode needle 1 is stopped (see FIG. 1), and the cooling operation (cooling) for the electrode needle 1 is stopped. This completes the series of processes shown in FIG. 5 (example of ablation process according to this embodiment).
  • the control unit 33 performs the following control at the time of ablation. That is, first, the control unit 33 measures the impedance value Z between the electrode needle 1 and the counter electrode plate 4 (step S12 in FIG. 5), and the impedance value Z exceeds the threshold value Zth and shifts to the break state. The number of times (break number Nb) is counted (step S14). Then, when the number of breaks Nb reaches the threshold value Nth, the control unit 33 automatically stops the supply of the power Pout to automatically end the ablation (step S18).
  • the present embodiment it becomes as follows. That is, for example, when the ablation is manually terminated after visually confirming the number of breaks Nb as described above (Comparative Example 1), or after a predetermined waiting time has elapsed without confirming the number of breaks Nb. Compared with the case of automatically terminating ablation (Comparative Example 2), effective ablation can be easily performed. Therefore, in the present embodiment, it is possible to improve the convenience when using the ablation system 5 as compared with these Comparative Examples 1 and 2.
  • the following processes preliminary detection process of signs of steam pop phenomenon and response processes when such signs are detected. I am trying to execute.
  • the above-mentioned detection processing and corresponding processing are performed during the period from the start of the above-mentioned ablation to the period before the transition to the first (first) break state.
  • An example of each of these cases will be described. However, the example is not limited to such a case, and such a detection process and a corresponding process may be performed at any time during an arbitrary period after the start of the above-mentioned ablation. This point is the same in the case of the processing example in the modification described later (processing example shown in FIGS. 10 to 14 described later).
  • FIG. 7 is a flow chart showing an example of the above-mentioned sign detection process and response process of the steam pop phenomenon in the ablation according to the present embodiment.
  • FIGS. 8 and 9 schematically show examples of timing waveforms during the processing shown in FIG. 7, respectively.
  • the horizontal axis represents time
  • the vertical axis represents the power supply value, the impedance value Z, and the measured temperature Tm near the tip of the electrode needle 1 described above. Is shown.
  • step S20 the control unit 33 acquires the measurement information of the power Pout, the measurement information of the impedance value Z, and the temperature information It indicating the measurement temperature Tm at this time point (see FIG. 1).
  • the control unit 33 in the period from the start of the above-mentioned ablation to the period before the transition to the first break state, the control unit 33, for example, sets the supply value of the power Pout. It is controlled to rise or maintain. Specifically, in the example of FIG. 8, the control unit 33 controls the supply value of the electric power Pout during this period so as to gradually increase (in a linear shape) along the time axis. On the other hand, in the example of FIG. 9, the control unit 33 controls the supply value of the electric power Pout during this period so as to rise or maintain in a stepwise manner along the time axis.
  • the control unit 33 may, for example, maintain the supply value of the electric power Pout during this period along the time axis (at an arbitrary fixed value). Further, the increase or maintenance of the power Pout supply value during this period is not automatically controlled by the control unit 33, but is manually controlled according to the operation (operation signal Sm) by the operator of the power supply device 3. It may be done.
  • the control unit 33 makes the following determination. That is, the control unit 33 determines whether or not the increase value per unit time (power increase value ⁇ P) in the supply value of the power Pout is equal to or greater than the threshold value ⁇ Pth set in step S10 of FIG. 5 described above ( ⁇ P ⁇ ⁇ Pth). Whether or not the condition is satisfied) is determined (step S21).
  • a threshold value ⁇ Pth for example, a value of about 5 [W] to 40 [W] can be mentioned, and for example, a value including 0 (zero) (for example, 0 [W] to 40 [W]]. (Value of degree) may be used.
  • the calculated value of such a power increase value ⁇ P may be reset (initialized), for example, when the state shifts to the break state described above.
  • step S21: N when it is determined that the power increase value ⁇ P is less than the threshold value ⁇ Pth (which does not satisfy ⁇ P ⁇ ⁇ Pth) (step S21: N), that is, when the power Pout is decreasing, the above step. It will return to S20.
  • step S21: Y when it is determined that the power increase value ⁇ P is equal to or greater than the threshold value ⁇ Pth (satisfying ⁇ P ⁇ ⁇ Pth) (step S21: Y), that is, when the power Pout is increased or maintained.
  • the control unit 33 makes the following determinations. That is, the control unit 33 determines whether or not the measured temperature Tm described above is changed by a decrease amount of the threshold value ⁇ Tmth or more set in step S10, that is, the change amount ⁇ Tm of the measured temperature Tm is the threshold value ⁇ Tmth or more. It is determined whether or not the amount of decrease is ( ⁇ Tm ⁇ ⁇ Tmth) (step S22).
  • a threshold value ⁇ Tmth for example, a value of about 5 [° C.] can be mentioned.
  • the change amount ⁇ Tm described above is a decrease amount less than the threshold value ⁇ Tmth ( ⁇ Tm ⁇ Tmth), or the change amount ⁇ Tm described above is an increase amount (measurement temperature Tm increases). If it is determined (step S22: N), the process returns to step S20 described above.
  • step S22 when it is determined that the above-mentioned change amount ⁇ Tm is a decrease amount of the threshold value ⁇ Tmth or more ( ⁇ Tm ⁇ ⁇ Tmth) (step S22: Y). ), Next, the control unit 33 executes the following processing. That is, in this way, when the predetermined condition that each determination in steps S21 and S22 is satisfied (becomes "Y") is satisfied (both (c) and (d) described later). In the present embodiment, the control unit 33 determines that the above-mentioned sign of the steam pop phenomenon has been detected, and executes the following corresponding processing (step S23).
  • the control unit 33 executes at least one of the following two processes (first process and second process) of (a) and (b).
  • the following process (a) is not automatically controlled by the control unit 33, but is manually controlled according to the operation (operation signal Sm) by the operator of the power supply device 3. May be good.
  • the control unit 33 performs the following control at the time of ablation. That is, when the control unit 33 satisfies the predetermined condition that both of the following (c) and (d) are applicable, of the above two processes (a) and (b). At least one of the processes is executed.
  • C The case where the supply value of the power Pout is controlled to be increased or maintained (the above-mentioned power increase value ⁇ P is equal to or higher than the threshold value ⁇ Pth including 0 (zero)) (d).
  • the measured temperature Tm changes with the amount of decrease of the threshold value ⁇ Tmth or more.
  • the measured temperature Tm changes by the amount of decrease of the threshold value ⁇ Tmth or more. If this is the case (when the above-mentioned predetermined conditions are satisfied), there is a possibility that the above-mentioned signs of the steam pop phenomenon have occurred in the vicinity of the ablation site (for example, the affected area 90 to be ablated) by the electrode needle 1. This is because when such a sign of the steam pop phenomenon occurs, an air layer is formed around the electrode needle 1, so that the measured temperature Tm near the tip of the electrode needle 1 tends to decrease. ..
  • FIG. 10 is a flow chart showing an example of the above-mentioned sign detection process and response process of the steam pop phenomenon at the time of ablation according to the modified example.
  • FIGS. 11 to 3 schematically show examples of timing waveforms during the processing shown in FIG. 10, respectively.
  • FIGS. 14 (A) and 14 (B) schematically show an example of a state at the time of a change in the reverse direction, which will be described later, shown in FIG. 13, respectively.
  • the horizontal axis represents time
  • the vertical axis represents the power supply value, the impedance value Z, and the above-mentioned electrode needle, respectively, as in FIGS. 8 and 9, respectively.
  • the measured temperature Tm near the tip of 1 is shown.
  • step S24 described below is added between steps S22 and S23. It corresponds to the one that has been made, and each other process is the same.
  • the control unit 33 indicates that the fluctuation value per unit time (impedance fluctuation value ⁇ Z) at the impedance value Z increases by the threshold value ⁇ Zth or more ( ⁇ Z ⁇ ⁇ Zth). It is determined whether or not, that is, whether or not the impedance fluctuation value ⁇ Z fluctuates with an increase value equal to or higher than the threshold value ⁇ Zth (step S24).
  • this threshold value ⁇ Zth corresponds to a specific example of the “second threshold value” in the present invention, and is set in step S10 of FIG. 5 described above, for example, like other threshold values. Further, as such a threshold value ⁇ Zth, for example, a value of about 10 [ ⁇ ] can be mentioned.
  • the impedance fluctuation value ⁇ Z is an increase value less than the threshold value ⁇ Zth ( ⁇ Z ⁇ Zth), or the impedance fluctuation value ⁇ Z is a decrease value (indicating a change in which the impedance value Z decreases). If it is determined (step S24: N), the process is as follows. That is, in this way, when the above-mentioned predetermined condition that each of the above-mentioned determinations of steps S21 and S22 is satisfied (becomes "Y") is satisfied, the above-mentioned step S24 is satisfied.
  • control unit 33 determines that the sign of the steam pop phenomenon described above has been detected, and executes the corresponding process described above (step S23). .. Specifically, in this case, the control unit 33 executes at least one of the two processes (a) and (b) described above. In this case, the series of processes shown in FIG. 10 (the process of detecting the sign of the steam pop phenomenon and the corresponding process according to this modification) are completed.
  • step S24: Y the process is as follows.
  • control unit 33 determines that the above-mentioned sign of the steam pop phenomenon has not been detected, and performs the above-mentioned corresponding processing (each of the above-mentioned processes (a) and (b)). Do not run. Specifically, in this case, the process does not proceed to step S23 described above, but returns to step S20 described above.
  • the measured temperature Tm and the impedance value Z fluctuate in opposite directions along the time axis. It may be determined whether or not each of the above-mentioned processes (a) and (b) is executed depending on whether or not the process is performed.
  • the control unit 33 has impedance when the measurement temperature Tm is lowered, for example, as shown by the broken arrow in FIGS. 11 and 12.
  • the impedance value Z decreases when the measured temperature Tm rises, and the measured temperature Tm and the impedance value Z fluctuate in opposite directions along the time axis. If so, the above-mentioned processes (a) and (b) may not be executed.
  • the fluctuation of the impedance value Z includes, for example, the fluctuation of the threshold value ⁇ Zth or more (for example, the fluctuation of about 10 [ ⁇ ] or more), and the fluctuation of the measurement temperature Tm is, for example, 10 [.
  • the fluctuations in the opposite directions between the measurement temperature Tm and the impedance value Z, for example, as shown in FIG. 13, have a predetermined period Tud (for example, Tud 5 seconds).
  • Tud 5 seconds
  • this modification shows the magnitude of the impedance fluctuation value ⁇ Z and the change of either increase or decrease even when the above-mentioned predetermined conditions are satisfied. Whether or not to execute the above-mentioned two processes (a) and (b) is determined according to the above. In other words, in this modification, an exclusion condition for executing these two processes is defined by using a parameter called the impedance fluctuation value ⁇ Z. As a result, in this modification, the above-mentioned sign of the steam pop phenomenon can be detected more accurately by using such a parameter of impedance fluctuation value ⁇ Z.
  • the measurement temperature Tm and the impedance value fluctuate in opposite directions along the time axis.
  • the above-mentioned processes (a) and (b) are prevented from being executed, the above-mentioned (a) is performed when the measured temperature Tm and the impedance value Z do not fluctuate in opposite directions along the time axis.
  • (B) When at least one of the two processes is executed, the result is as follows.
  • each member described in the above-described embodiment and the like are not limited, and may be other materials.
  • the configuration of the electrode needle 1 has been specifically described, but it is not always necessary to include all the members, and other members may be further provided.
  • the values, ranges, magnitude relations, etc. of various parameters described in the above-described embodiments are not limited to those described in the above-described embodiments, and may be other values, ranges, magnitude relations, etc. good.
  • the block configurations of the liquid supply device 2 and the power supply device 3 have been specifically described, but it is not always necessary to include all the blocks described in the above-described embodiment and the like. Other blocks may be further provided. Further, the ablation system 5 as a whole may be further provided with other devices in addition to the devices described in the above-described embodiment and the like.
  • control operation in the control unit 33 including the power supply control function and the liquid supply control function has been specifically described.
  • control method in these power supply control functions, liquid supply control functions, and the like is not limited to the methods mentioned in the above-described embodiments.
  • the ablation processing example shown in FIG. 5 and the like and the above-mentioned examples of the steam pop phenomenon sign detection processing and the corresponding processing shown in FIGS. 7 and 10, are described in the above-mentioned implementation.
  • the method is not limited to the method described in the form or the like, and other methods may be used.
  • the series of processes described in the above-described embodiment or the like may be performed by hardware (circuit) or software (program).
  • the software is composed of a group of programs for executing each function by a computer.
  • Each program may be used by being preliminarily incorporated in the computer, for example, or may be installed and used in the computer from a network or a recording medium.

Abstract

L'invention concerne un système d'ablation pouvant atténuer la charge sur le corps d'un patient pendant une ablation. Ce système d'ablation 5 comprend une aiguille d'électrode 1 et un dispositif de source d'énergie 3 présentant une unité de commande 33 et une unité de source d'énergie 32 pour fournir de l'énergie Pout. L'unité de commande 33 est conçue de telle sorte que, pendant l'ablation, des informations (informations de température It) indiquant la température de mesure Tm à proximité de l'extrémité avant de l'aiguille d'électrode 1 sont fournies à partir de l'aiguille d'électrode 11 à l'unité de commande 33. Pendant l'ablation, si, lors de la réalisation d'une commande pour élever ou maintenir la valeur d'alimentation d'énergie Pout, la température de mesure Tm satisfait à une condition prédéterminée de variation par une quantité de diminution (quantité de variation ΔTm) supérieure ou égale à une valeur seuil ΔTmth, l'unité de commande 33 exécute au moins un traitement parmi un premier traitement, pour diminuer ou arrêter l'alimentation de l'énergie Pout, et un deuxième traitement pour émettre une notification prédéterminée à l'extérieur du dispositif de source d'énergie 3.
PCT/JP2020/040904 2020-10-30 2020-10-30 Système d'ablation WO2022091369A1 (fr)

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