High frequency treatment device and high frequency treatment method

Abstract

[Problem] To provide a high frequency treatment device and high frequency treatment method whereby an intermittent high frequency current can be more effectively applied to a subject to be treated. [Solution] A high frequency treatment device comprising: an output unit that outputs high frequency power; an electrode that is connected to the output unit and is placed on the subject to be treated; and a control unit that controls the output unit such that high frequency power is intermittently output on the basis of a preset output pattern, wherein the output pattern is set such that a plurality of output periods T1 during which the high frequency power is outputted are set with different time lengths, and such that for each of the plurality of output periods T1, the output period T1 is generated in a different individual period T5.

Description

High frequency treatment device and high frequency treatment method

[0001] The present invention relates to a high-frequency treatment device and a high-frequency treatment method for treating a treatment target such as a human being or an animal by passing a high-frequency current through the target.

[0002] Pulsed radiofrequency (PRF) is a well-known treatment for chronic pain. PRF involves passing a high-frequency current intermittently (in pulses) through electrodes into the target living body, generating an electric field that affects nerve tissue and other tissues, thereby alleviating pain (see, for example, Non-Patent Document 1).

[0003] Generally, pulsed radiofrequency therapy is performed by passing a pulse wave of high-frequency current (e.g., 480 kHz) through a living body for several minutes at a constant frequency (e.g., 2 Hz) and a constant pulse width (e.g., 20 milliseconds). In other words, conventional pulsed radiofrequency therapy is performed by intermittently passing a high-frequency current for several minutes with a constant output period (e.g., 20 milliseconds) and a constant output stop period (e.g., 480 milliseconds). In addition, in pulsed radiofrequency therapy, the temperature around the electrode is maintained below a predetermined threshold (42-45°C) during treatment to prevent degeneration of neural tissue.

[0004] Yuko Nishiwaki, Kiyoshi Fukui, "Pulsed Radiofrequency Therapy (PRF) Devices," Medical Device Studies, Japan Society of Medical Devices, 2020, Vol. 90, No. 3, pp. 290-295

[0005] However, in conventional devices that perform pulsed high frequency therapy, if the temperature measurement value during treatment exceeds a threshold value, the temperature around the electrode is kept below the threshold value by controlling the output voltage of the high frequency power or by stopping the output of the high frequency power.

[0006] Therefore, if the output voltage or duty ratio (pulse width divided by period) is set high in order to increase the impact on nerve tissue, etc., the temperature around the electrode is also likely to rise, which can lead to an unintended drop in output voltage or output cessation during treatment by the device user (doctor, etc.), and if this occurs frequently, there is a problem that a sufficient analgesic effect cannot be obtained.

[0007] In view of the above circumstances, the present invention aims to provide a high-frequency treatment device and a high-frequency treatment method that can more effectively pass an intermittent high-frequency current through a treatment target.

[0008] The high-frequency treatment device of the present invention comprises an output unit that outputs high-frequency power, an electrode connected to the output unit and placed on the treatment target, and a control unit that controls the output unit so that the high-frequency power is output intermittently based on a preset output pattern, wherein the output pattern is set so that a plurality of output periods for outputting the high-frequency power are set with different time lengths, and the output period occurs at a different individual cycle for each of the plurality of output periods.

[0009] Furthermore, the high-frequency treatment method of the present invention is a high-frequency treatment method in which treatment is performed by intermittently outputting high-frequency power to electrodes placed on a treatment target in a preset output pattern, characterized in that the output pattern is set to multiple output periods for outputting the high-frequency power with different time lengths, and the output period is set to occur at a different individual cycle for each of the multiple output periods.

[0010] According to the high-frequency treatment device and high-frequency treatment method of the present invention, the duty ratio can be appropriately changed during treatment, i.e., periods with high duty ratios and periods with low duty ratios can be appropriately mixed during the treatment period, so that it is possible to reliably affect nervous tissue, etc. during periods with high duty ratios while suppressing the rise in temperature around the electrode during periods with low duty ratios.

[0011] This eliminates the need for output control to lower the temperature around the electrodes, allowing the treatment to be completed as intended by the user, and the analgesic effect to be obtained as intended by the user. In other words, the intermittent high-frequency current can be more effectively applied to the treatment target.

[0012] In the high-frequency treatment apparatus of the present invention, it is preferable that the output pattern is set such that the longer the time length of the output period is, the longer the time length of the individual cycle is.

[0013] This makes it possible to reduce the frequency of long output periods to suppress a rise in temperature around the electrode, while increasing the frequency of short output periods to ensure the degree of influence on nervous tissue, etc. Furthermore, since the duty ratio can be changed so as to fluctuate irregularly rather than being changed uniformly during treatment, it is possible to prevent the treatment subject from adapting to the change in duty ratio, and to more effectively pass an intermittent high-frequency current through the treatment subject.

[0014] In the high-frequency treatment device of the present invention, it is preferable that the output pattern is set so that the time length of the output period is proportional to the time length of the individual cycle in the set plurality of output periods.

[0015] This makes it possible to approximate the fluctuations in the change in duty ratio during treatment to 1 / f fluctuations, which have a high affinity with living organisms, thereby reducing the sense of discomfort or discomfort felt by the treatment subject during treatment and allowing intermittent high-frequency current to be passed through the treatment subject more effectively.

[0016] The high-frequency treatment device and high-frequency treatment method of the present invention can provide the excellent effect of more effectively passing an intermittent high-frequency current through a treatment target.

[0017] Fig. 1 is a schematic diagram showing the appearance of a high-frequency treatment device according to an embodiment of the present invention. Fig. 2 is a block diagram showing an outline of the internal configuration of a high-frequency treatment device. Fig. 3 is a schematic diagram showing the waveform of AC power output by an output unit in a pulse high-frequency method. Fig. 4 is a diagram showing an output pattern according to an embodiment of the present invention in the form of a table. Fig. 5 is a time chart showing the output mode of high-frequency power in an embodiment of the present invention. Fig. 6 is a graph showing the time-series change in the cumulative value of the output period in the output pattern. Fig. 7 is a graph showing the temperature measurement results of an example.

[0018] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.

[0019] 1 is a schematic diagram showing the appearance of a high-frequency treatment device 1 according to an embodiment of the present invention. The high-frequency treatment device 1 of this embodiment is used to perform treatment for the purpose of alleviating pain, etc., by applying a high-frequency voltage to a living body such as a human or animal that is a treatment target, thereby causing a high-frequency current to flow within the living body.

[0020] The high-frequency treatment device 1 is configured to perform not only the pulse high-frequency method, which causes an electric field formed inside the living body by intermittently (intermittently) passing a high-frequency current inside the living body to act on nervous tissue, etc., but also other treatments such as high-frequency thermocoagulation, which heats and denatures nervous tissue using a high-frequency current. However, only the configuration and functions related to the pulse high-frequency method will be explained below.

[0021] As shown in FIG. 1, the high-frequency treatment device 1 includes a main body 10 , four electrodes 20 connected to the main body 10 , and a return electrode plate 30 connected to the main body 10 .

[0022] The main body 10 houses or supports the internal components described below. On the front of the main body 10, four electrode connectors 11 to 14 to which electrodes 20 are connected, and a return electrode connector 15 to which a return electrode 30 is connected are provided at the bottom. Also provided on the front of the main body 10 is an operation unit 16 that accepts user operations. The operation unit 16 is composed of a touch panel display 16a that accepts input operations such as various settings and displays various information, a button 16b that accepts operations to start and end treatment, and a control knob 16c for adjusting the output voltage.

[0023] A handle 17 is provided on the top of the main body 10 for carrying the main body 10. Although not shown, a power connector and a power switch are provided on the back of the main body 10 for connecting to a commercial AC power source to receive power.

[0024] The electrode 20 is inserted into a target for high-frequency treatment to pass a high-frequency current through the target. In this embodiment, the electrode 20 is configured in a needle-like tube shape that can be directly inserted into the human body, etc. The electrode 20 has an insulating coated insulating portion 20b except for a non-insulating portion 20a at the tip, and the high-frequency current is output from the non-insulating portion 20a. The electrode 20 also has a built-in thermocouple 20c for measuring the temperature around the electrode 20 during treatment.

[0025] The electrodes 20 are electrically connected to the main body 10 via an electrode cable 21 and electrode connectors 11 to 14. In this embodiment, up to four electrodes 20 can be used simultaneously. The electrodes 20 may have other shapes, such as a rod-like shape that is inserted into a needle tube or catheter, or a pad-like shape that is placed on the surface of a living body. The thermocouple 20c may be provided separately from the electrodes 20.

[0026] The return electrode 30 is a flat electrode that is attached to the surface of the treatment target and is used to pass a high-frequency current between the return electrode 30 and the electrode 20. The return electrode 30 is electrically connected to the main body 10 via a return electrode cable 31 and a return electrode connector 15. In this embodiment, the return electrode 30 is configured as a rectangular flat plate, but the return electrode 30 may have other shapes.

[0027] Fig. 2 is a block diagram showing an outline of the internal configuration of the high-frequency treatment device 1. As shown in Fig. 2, the high-frequency treatment device 1 includes an output unit 40, a switching unit 50, a temperature measurement unit 60, a voltage measurement unit 71, a current measurement unit 72, a main control unit 80, and a sub-control unit 90 as its internal configuration.

[0028] The output unit 40 generates and outputs high-frequency power of a preset frequency (e.g., 470 to 490 kHz) and a voltage (e.g., 18 to 80 Vrms) based on power supplied from a commercial AC power source. The output unit 40 is connected to the electrode connectors 11 to 14 and the return electrode connector 15 via a switching unit 50. Therefore, the electrode 20 is connected to the output unit 40 via the electrode connectors 11 to 14 and the switching unit 50. The output unit 40 is composed of known circuits each having a transformer, which isolates the treatment target from the commercial AC power source.

[0029] The switching unit 50 operates under the control of the sub-controller 90 and switches the connection state between the output unit 40 and the electrode connectors 11 to 14 and the return electrode connector 15 depending on the treatment to be performed. The switching unit 50 in this embodiment is composed of multiple reed relays, but may also be composed of a semiconductor switch or the like.

[0030] The temperature measurement unit 60 is configured with known circuits and the like, generates a temperature measurement signal based on a signal received from the thermocouple 20c, and transmits it to the sub-controller 90. In this embodiment, the temperature measurement unit 60 is connected to the thermocouple 20c in the electrode 20 via the electrode connectors 11 to 14, but a separate connector for the thermocouple 20c may also be provided.

[0031] The voltage measurement unit 71 is configured from known circuits, etc., and measures the voltage of the high-frequency power output by the output unit 40. The voltage measurement unit 71 generates a voltage measurement signal based on the high-frequency voltage generated by the output unit 40, and transmits it to the main control unit 80. The current measurement unit 72 is configured from known circuits, etc., and individually measures the high-frequency currents flowing through the four electrodes 20. The current measurement unit 72 generates a current measurement signal based on the high-frequency currents flowing through the electrodes 20, and transmits it to the main control unit 80.

[0032] The main control unit 80 has a known configuration including a CPU, ROM, RAM, etc., and controls each unit of the high-frequency treatment device 1 to perform high-frequency treatment. The main control unit 80 starts and ends high-frequency treatment based on input operations received by the operation unit 16 and information stored in the ROM, etc. During treatment, the main control unit 80 also displays information such as elapsed time, measured voltage values, measured current values, and measured temperature values ​​on the touch panel display 16a.

[0033] The sub-controller 90, like the main controller 80, has known components such as a CPU, ROM, and RAM, and controls the switching unit 50 and the temperature measuring unit 60. In this embodiment, the sub-controller 90, which controls the switching unit 50 and the like that are provided closer to the treatment target than the output unit 40, is provided separately from the main controller 80, thereby achieving more complete insulation between the treatment target and the commercial AC power supply.

[0034] 3 is a schematic diagram showing the waveform of AC power output by the output unit 40 in the pulsed high frequency method, with the vertical axis representing voltage V and the horizontal axis representing time T. In the pulsed high frequency method, the output unit 40 is controlled by the main control unit 80 to intermittently output high frequency power at a predetermined frequency F1 (e.g., 480 kHz).

[0035] 3, the output unit 40 outputs high-frequency power in the following manner: it outputs high-frequency power for an output period T1a, then stops outputting the high-frequency power for an output stop period T2a, then it outputs high-frequency power for an output period T1b, then stops outputting the high-frequency power for an output stop period T2b, etc. In other words, the output unit 40 outputs a pulse wave having a pulse width T1 and a period T3 that are longer than the period C1 of the high-frequency wave.

[0036] The duty ratio in cycle T3a is the value obtained by dividing the output period T1a by cycle T3a, the duty ratio in cycle T3b is the value obtained by dividing the output period T1b by cycle T3b, and the average duty ratio in cycle T4 is the value obtained by dividing the sum of the output periods T1a and T1b by cycle T4.

[0037] In the conventional pulsed radiofrequency method, radiofrequency power is output with constant output period T1 and output stop period T2, i.e., a pulse wave with constant pulse width T1 and period T3 is output. When the measured temperature around the electrode 20 exceeds a predetermined threshold (42 to 45°C, the upper limit of the temperature at which cells are not destroyed), output control is performed, such as reducing the output voltage or stopping the output.

[0038] As a result, an unintended drop in output voltage or stoppage of output may occur during treatment, unintentionally caused by the doctor or other person using the device, and if this occurs frequently, there is a problem that a sufficient analgesic effect cannot be obtained.

[0039] Therefore, in this embodiment, high-frequency power is output while varying the output period T1 and output stop period T2 as shown in Figure 3 based on a preset output pattern, thereby suppressing the rise in temperature around the electrode 20 and making it possible to complete the treatment as intended by the user without controlling the output of high-frequency power based on temperature measurement values ​​during treatment.

[0040] 4 is a table showing output patterns according to this embodiment. In this output pattern, five pulse widths T1 are set: 2 milliseconds, 4 milliseconds, 6 milliseconds, 8 milliseconds, and 10 milliseconds. Each pulse is output at a different individual period T5. Specifically, pulses with a pulse width T1 of 2 milliseconds are output at an individual period T5 of 250 milliseconds, pulses with a pulse width T1 of 4 milliseconds are output at an individual period T5 of 500 milliseconds, pulses with a pulse width T1 of 6 milliseconds are output at an individual period T5 of 750 milliseconds, pulses with a pulse width T1 of 8 milliseconds are output at an individual period T5 of 1000 milliseconds, and pulses with a pulse width T1 of 10 milliseconds are output at an individual period T5 of 1250 milliseconds.

[0041] That is, in the output pattern of this embodiment, the time length of the individual period T5 is set to be proportional to the time length of the pulse width T1, and the longer the time length of the output period T1, the longer the time length of the individual period T5 becomes in proportion thereto.

[0042] In this output pattern, the output of pulses with each pulse width T1 is shifted by an output interval T6 to prevent the output timing of pulses with each pulse width T1 from overlapping. Specifically, in this output pattern, the shortest individual period T5 (250 milliseconds) divided by the number of pulse widths (5) is used as the output interval T6 (50 milliseconds).

[0043] Therefore, the output timing of pulses of each pulse width T1 in this output pattern is 0 milliseconds (simultaneous with the start), 250 milliseconds, 500 milliseconds, 750 milliseconds, etc. from the start of output for a pulse width T1 of 2 milliseconds; 50 milliseconds, 550 milliseconds, 1050 milliseconds, 1550 milliseconds, etc. from the start of output for a pulse width T1 of 4 milliseconds; 100 milliseconds, 850 milliseconds, 1600 milliseconds, 2350 milliseconds, etc. from the start of output for a pulse width T1 of 6 milliseconds; 150 milliseconds, 1150 milliseconds, 2150 milliseconds, 3150 milliseconds, etc. from the start of output for a pulse width T1 of 8 milliseconds; and 200 milliseconds, 1450 milliseconds, 2700 milliseconds, 3950 milliseconds, etc. from the start of output for a pulse width T1 of 10 milliseconds.

[0044] 5 is a time chart showing the output mode of high-frequency power in this embodiment. The main control unit 80 controls the on / off of the output of high-frequency power from the output unit 40 based on the output pattern stored in the ROM, i.e., executes output during the output period T1 and output stop during the output stop period T2.

[0045] As described above, pulses with each pulse width T1 are output at a fixed individual period T5, and the timing at which the pulses start output is shifted by an output interval T6. In this embodiment, by combining a plurality of regular pulse outputs with fixed pulse widths T1 and fixed individual periods T5, high-frequency power is output in a manner in which the output period (pulse width) T1 and output stop period T2 change irregularly, as shown in the bottom time chart.

[0046] In this way, by varying the output period T1 and the output stop period T2, it is possible to reliably affect the nervous tissue, etc., during the period with a high duty ratio, while suppressing the rise in temperature around the electrode 20 during the period with a low duty ratio. Furthermore, by making the output period T1 and the output stop period T2 vary irregularly, it is possible to suppress the adaptation of the nervous tissue, etc., to the electric field, and to more effectively affect the nervous tissue, etc.

[0047] In this embodiment, by setting the time length of the output period T1 to 10 milliseconds or less, it is possible to suppress excessive temperature rise while maintaining the average duty ratio per treatment equivalent to that of conventional pulsed radiofrequency therapy (approximately 0.04). Furthermore, by setting the time length of the individual period T5 to be longer as the time length of the output period T1 is longer, the frequency of long output periods T1 is reduced to suppress temperature rise around the electrode 20, while the frequency of short output periods T1 is increased to ensure the degree of impact on nervous tissue, etc.

[0048] In this embodiment, the individual cycle T5 of each output period T1 is fixed, which makes it easier to calculate the average duty ratio for one treatment, and makes it easier to create an output pattern according to the condition of the treatment target, the type of nerve fiber to be treated, etc.

[0049] 6 is a graph showing the time-series change in the cumulative value of the output period T1 in the output pattern of this embodiment. In the graph of FIG. 6, the cumulative value of the output period T1 is plotted at the end of each output period T1. Therefore, the slope between the start and end points of any period in the graph of FIG. 6 is the average duty ratio for that period.

[0050] 6, in the output pattern of this embodiment, the slope of the graph of the cumulative value of the output period T1 (i.e., the duty ratio) shows a seemingly regular but irregular change, such as the flickering of a candle flame. Note that in the output pattern of this embodiment, the least common multiple of the individual periods T5 is 15,000 milliseconds, so the same change in the duty ratio is repeated every 15 seconds.

[0051] In this embodiment, by setting the time length of the individual period T5 to correspond to the time length of the output period T1, it is possible to change the duty ratio so that it fluctuates irregularly during treatment, making it possible to more effectively suppress the treatment subject's adaptation to the change in duty ratio. Furthermore, by setting the time length of the output period T1 and the time length of the individual period T5 to be proportional (the individual frequencies are inversely proportional), the fluctuation in the change in duty ratio during treatment is made to approximate 1 / f fluctuation, which has a high affinity with living organisms, making it possible to reduce the discomfort or annoyance felt by the treatment subject during treatment.

[0052] In this embodiment, five different lengths of the output period T1 ranging from 2 to 10 milliseconds are used, but the length and number of lengths of the output period T1 are not limited to these and any value can be used depending on the condition of the treatment target, etc. The same applies to the individual period T5 and the output interval T6.

[0053] Furthermore, the order in which the output of pulses of each time length is started is not particularly limited, and any order can be adopted. Furthermore, the time length of the individual period T5 is preferably set to a length corresponding to the output period T1, but other settings can be adopted depending on the condition of the treatment target, etc. Furthermore, it goes without saying that instead of using only one output pattern in one treatment, multiple types of output patterns may be used.

[0054] The high-frequency treatment device 1 may also be equipped with only one of the electrode connectors 11 to 14, in which case the switching unit 50 can be omitted. The high-frequency treatment device 1 may also be equipped with a plurality of return electrode connectors 15. The high-frequency treatment device 1 may also be equipped with a plurality of output units 40 or a plurality of temperature measuring units 60 according to the number of electrode connectors 11 to 14. The high-frequency treatment device 1 may also not be equipped with the sub-controller 90, and the main controller 80 may control the switching unit 50 and the temperature measuring unit 60.

[0055] Furthermore, the high-frequency treatment device 1 may be capable of performing the pulsed high-frequency treatment based on the output pattern stored in the ROM, as well as the pulsed high-frequency treatment based on a fixed output period T1 and output stop period T2 set by the user. Furthermore, the high-frequency treatment device 1 may be capable of performing the pulsed high-frequency treatment based not only on the output pattern stored in the ROM, but also on the output pattern stored in a flash memory or the like connected to the main control unit 80, or on the output pattern acquired through communication with an external device.

[0056] The above describes an embodiment of the present invention, but the high-frequency treatment device and high-frequency treatment method of the present invention are not limited to the above-mentioned embodiment, and it goes without saying that various modifications can be made within the scope that does not deviate from the gist of the present invention.

[0057] Furthermore, the actions and effects shown in the above-described embodiments are merely a list of the most preferable actions and effects resulting from the present invention, and the actions and effects of the present invention are not limited to these.

[0058] Next, an embodiment of the present invention will be described.

[0059] An electrode and a counter electrode were placed on the pork, and a high-frequency current of 70 V was applied based on an output pattern with an average duty ratio of 0.015 and 10 different output periods (pulse widths). The temperature around the electrode was measured using a thermocouple built into the electrode. The measurement time was 540 seconds (9 minutes), and the temperature measurement sampling frequency was 1 Hz. The initial temperature of the pork was room temperature, and the impedance value was set to 200 Ω by adjusting the contact area between the counter electrode and the pork.

[0060] 7 is a graph showing the temperature measurement results of the example. As shown in FIG. 7, according to the output pattern of the example, it was confirmed that the temperature around the electrode rose by about 6 to 7°C after the start of output, and then remained at a substantially constant value while the output continued. In other words, the effectiveness of the present invention was confirmed.

[0061] 1 High-frequency treatment device 20 Electrode 40 Output unit 80 Main control unit T1 Output period T5 Individual cycle

Claims

1. An output unit that outputs high-frequency power, an electrode connected to the output unit and disposed on a treatment target, and a control unit that controls the output unit so that the high-frequency power is intermittently output based on a preset output pattern. The output pattern is characterized in that a plurality of output periods for outputting the high-frequency power are set with different time lengths, and the output periods occur at different individual periods for each of the plurality of output periods. A high-frequency treatment device.

2. The high-frequency treatment device according to claim 1, wherein in the plurality of set output periods of the output pattern, the longer the time length of the output period, the longer the time length of the individual period is set. A high-frequency treatment device.

3. The high-frequency treatment device according to claim 1, wherein in the plurality of set output periods of the output pattern, the time length of the output period and the time length of the individual period are set to be proportional. A high-frequency treatment device.

4. In a high-frequency treatment method of performing a treatment by intermittently outputting high-frequency power to an electrode disposed on a treatment target with a preset output pattern, the output pattern is characterized in that a plurality of output periods for outputting the high-frequency power are set with different time lengths, and the output periods occur at different individual periods for each of the plurality of output periods. A high-frequency treatment method.

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