WO2022138402A1 - 電極ユニットおよび高周波処置装置 - Google Patents

電極ユニットおよび高周波処置装置 Download PDF

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Publication number
WO2022138402A1
WO2022138402A1 PCT/JP2021/046384 JP2021046384W WO2022138402A1 WO 2022138402 A1 WO2022138402 A1 WO 2022138402A1 JP 2021046384 W JP2021046384 W JP 2021046384W WO 2022138402 A1 WO2022138402 A1 WO 2022138402A1
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Prior art keywords
electrode
electrode unit
high frequency
storage device
unit
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Ceased
Application number
PCT/JP2021/046384
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English (en)
French (fr)
Japanese (ja)
Inventor
敦 池内
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Top KK
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Top KK
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Priority to EP21910550.9A priority Critical patent/EP4233754A4/en
Priority to JP2022572244A priority patent/JPWO2022138402A1/ja
Publication of WO2022138402A1 publication Critical patent/WO2022138402A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00172—Connectors and adapters therefor
    • A61B2018/00178—Electrical connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1475—Electrodes retractable in or deployable from a housing

Definitions

  • the present invention relates to an electrode unit and a high-frequency treatment apparatus used in high-frequency treatment in which a high-frequency current is applied from an electrode placed on a treatment target such as a human or an animal to perform treatments such as thermal coagulation of nerve tissue and cauterization of tumor tissue. ..
  • the electrodes used for high frequency treatment are connected to the main body (high frequency power generator) that generates high frequency power via a connector. That is, in the high frequency treatment device that performs high frequency treatment, the electrode unit including the electrode and the connector connected to the electrode is a replacement part that is detachably connected to the main body. By doing so, it is possible not only to facilitate the replacement of electrodes according to the occurrence of defects and the number of times of use, but also to facilitate the sterilization and disinfection of electrodes arranged in the body of humans, animals and the like. Therefore, it is possible to appropriately perform high frequency treatment.
  • an inappropriate electrode unit may be used, for example, a model that does not fit the main body or a model that exceeds the expiration date or the usage limit. .. If an inappropriate electrode unit is used, the output control of high-frequency power becomes unstable, and not only the treatment is not performed properly, but also the safety may be impaired.
  • the present invention is intended to provide an electrode unit and a high frequency treatment apparatus capable of appropriately performing high frequency treatment.
  • the electrode unit of the present invention includes an electrode arranged on a treatment target, a storage device for storing information about the electrode, and a connector for connecting the electrode and the storage device to the high frequency power generation device for generating high frequency power. It is characterized by being prepared.
  • the high frequency treatment device of the present invention is characterized by including the electrode unit of the present invention and the high frequency power generation device.
  • the present invention it is possible to determine whether or not the electrode unit connected to the high-frequency power generator can be appropriately used based on the information stored in the storage device. The procedure can be taken appropriately.
  • the storage device is arranged in the connector.
  • the storage device can be arranged without significantly changing the shape of the electrode unit, the usability of the electrode unit can be maintained even though the storage device is provided.
  • the connector has a contact terminal electrically connected to the high frequency power generator, and the storage device has its own connection terminal directly connected to the contact terminal. Therefore, it is preferable that the connector is fixed to the connector.
  • the storage device can be fixed to the connector only by soldering, for example, without separately providing a support member or the like, so that the manufacturing cost can be reduced.
  • the electrode unit of the present invention includes a temperature sensor connected to the high frequency power generation device via the connector, and the storage device stores information regarding temperature measurement by the temperature sensor.
  • thermocouple connected to the connector via a compensating lead wire
  • thermocouple and the compensating lead wire are , It is preferable to be connected via a bridge substrate arranged in the hub.
  • the end of the thermocouple and the compensating lead wire can be connected to a predetermined position on the bridge board by soldering or the like, and the end can be positioned and fixed to connect the two. It is possible to achieve both reliable prevention of short circuit and facilitation of manufacturing.
  • the electrode unit and the high frequency treatment device of the present invention it is possible to achieve an excellent effect that high frequency treatment can be appropriately performed.
  • FIG. 1 is a schematic view showing the appearance of the high frequency treatment device 1 according to the embodiment of the present invention.
  • the high-frequency treatment device 1 of the present embodiment is for performing nerve block by partially heating peripheral nerves with a high-frequency current.
  • the high frequency treatment device 1 includes a main body 10 which is a high frequency power generation device, four electrode units 20 connected to the main body 10, a counter electrode unit 30 connected to the main body 10, and a main body.
  • the operation switch unit 40 connected to the 10 is provided.
  • the main body 10 generates and outputs high frequency power.
  • An operation unit 16 that receives a user's operation is also provided on the front surface of the main body 10.
  • 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 start and end operations of treatment, and a control knob 16c for adjusting output power. It is configured.
  • a main body side connector 17 to which the operation switch unit 40 is connected is provided on the left side surface of the main body 10. Further, a handle 18 for carrying the main body 10 is provided on the upper portion of the main body 10. Although not shown, the back surface of the main body 10 is provided with a power connector and a power switch that are connected to a commercial AC power source to receive power.
  • an output unit 10a Inside the main body 10, an output unit 10a, a switching unit 10b, a temperature measuring unit 10c, and a control unit 10d are provided.
  • the output unit 10a generates and outputs high-frequency power having a predetermined frequency (for example, 470 to 490 kHz) and a voltage (for example, 18 to 22 Vrms) based on the power supplied from the commercial AC power supply.
  • the output unit 10a is connected to the main body side connectors 11 to 15 via the switching unit 10b.
  • the switching unit 10b switches the connection mode between the output unit 10a and the main body side connectors 11 to 15.
  • the temperature measuring unit 10c receives a temperature measuring signal (for example, a voltage due to thermoelectromotive force in this embodiment) received from a temperature sensor (thermocouple 23 described later in this embodiment) included in the electrode unit 20. 25 mV / ° C.) is generated and transmitted to the control unit 10d.
  • the control unit 10d controls each unit of the high frequency treatment device 1 to execute high frequency treatment. Since the configurations of each part of the main body 10 are known configurations, detailed description thereof will be omitted.
  • the electrode unit 20 includes an electrode 21 to be inserted into the body of a patient to be treated with high frequency treatment, and is detachably connected to the main body 10. That is, the electrode unit 20 makes the electrode 21 replaceable with respect to the main body 10. The details of the electrode unit 20 will be described later.
  • the counter electrode plate unit 30 includes a counter electrode plate 31 which is a flat plate-shaped electrode attached and arranged on the skin surface of the patient to be treated, and is detachably connected to the main body 10. That is, the counter electrode plate 31 is replaceable with respect to the main body 10 like the electrode 21.
  • the counter electrode plate unit 30 includes a counter electrode plate 31, a counter electrode plate side connector 32 connected to the main body side connector 15, and a counter electrode plate cable 33 connecting the counter electrode plate 31 and the counter electrode plate side connector 32.
  • the operation switch unit 40 is provided to the patient to be treated during the treatment, and is operated when the patient feels pain.
  • the operation switch unit 40 is composed of an operation switch 41 that is pressed by a patient, an operation switch side connector 42 that is connected to the main body side connector 17, and an operation switch cable 43 that connects the operation switch 41 and the operation switch side connector 42. It is configured.
  • the control unit 10d controls the output unit 10a to output high frequency power, and controls the switching unit 10b between the plurality of electrodes 21, or with one or more electrodes 21 and the counter electrode plate.
  • a high frequency current is allowed to flow between 31.
  • a high-frequency current flows in the patient's body.
  • the control unit 10d also controls the output of high-frequency power so that the temperature measurement value based on the temperature measurement signal received from the temperature measurement unit 10c is substantially equal to the preset temperature set value (control target value). Further, the control unit 10d reduces the output of high frequency power to the output unit 10a based on the operation of the operation switch 41 during the treatment.
  • FIG. 2 is a schematic view showing the appearance of the electrode unit 20.
  • the electrode unit 20 includes an electrode 21, a hub 22 connected to the rear end of the electrode 21, and a thermocouple 23 (temperature sensor) arranged inside the electrode 21 and the hub 22.
  • the electrode-side connector 24 connected to the main body-side connectors 11 to 14 and the electrode cable 25 connecting the hub 22 and the electrode-side connector 24 are provided.
  • the electrode unit 20 also includes a storage device 26 arranged in the electrode-side connector 24.
  • the electrode 21 is an elongated tubular member made of a conductive metal.
  • the electrode of the present embodiment is used by being inserted into a needle tube 50 punctured by the treatment target 100. Therefore, the tip of the electrode 21 is closed and rounded. Further, the electrode 21 is an insulating portion 21b in which most of the electrode 21 is insulatingly coated except for the non-insulating portion 21a at the tip portion. Therefore, the high frequency current is output from the non-insulated portion 21a exposed at the tip of the needle tube 50.
  • FIG. 3 is a schematic side sectional view of the electrode 21 and the hub 22.
  • the hub 22 is a stepped cylindrical (hollow) member made of an appropriate insulating resin.
  • An electrode 21 is inserted on the tip end side of the hub 22 and adhered with an appropriate adhesive.
  • an electrode cable 25 is inserted together with a tubular lid member 22a on the rear end side of the hub 22, and is adhered with an appropriate adhesive. Therefore, the inside of the hub 22 is substantially sealed.
  • thermocouple 23 is arranged inside the electrode 21 along the longitudinal direction of the electrode 21, and the temperature measuring contact 23a is located inside the non-insulated portion 21a of the electrode 21.
  • the thermocouple 23 and the electrode 21 are insulated from each other by the insulating material filled in the electrode 21, but the temperature measuring contact 23a may be connected to the electrode 21.
  • a K type (combination of chromel and alumel) thermocouple 23 is used, but it goes without saying that the type of thermocouple is not limited.
  • thermocouple 23 is connected to a pair of compensating conductors 28a and 28b via a bridge substrate 27 arranged inside the hub 22.
  • the bridge substrate 27 has a circuit 27b printed on the surface of a substrate 27a made of an insulating material, and the thermocouple 23 and the compensating conductors 28a and 28b are connected to the circuit 27b by soldering.
  • thermocouple 23 and the compensating conductors 28a and 28b via the bridge substrate 27 having a relatively high rigidity in this way, both reliable short-circuit prevention and easy manufacturing are achieved. Specifically, since the ends of the thermocouple 23 and the compensating conductors 28a and 28b, which are easily moved due to bending deformation, can be positioned and fixed on the bridge substrate 27, short-circuiting of the thermocouple 23 can be reliably prevented. Is possible. Further, since the thermocouple 23 and the compensating conductors 28a and 28b can be connected to each other simply by soldering them to predetermined positions on the bridge substrate 27, the production can be facilitated.
  • the bridge substrate 27 is fixed in the hub 22 by filling the inside of the hub 22 with an insulating resin, which also realizes simplification of manufacturing and cost reduction. is doing. That is, the configuration of the hub 22 is simplified, and operations such as positioning of the bridge substrate 27 and engagement with the hub 22 at the time of manufacturing are omitted, facilitating manufacturing and reducing costs.
  • the T type (combination of copper and constantan) is used as the compensating conductors 28a and 28b, and the copper compensating conductor 28a is also used as the compensating lead wire 28a for high-frequency current, thereby facilitating manufacturing and costing.
  • the electrode 21 and the circuit 27b of the bridge substrate 27 are connected via the intermediate wiring 29, but the rear end portion of the electrode 21 may be directly connected to the circuit 27b by soldering or the like. good.
  • FIG. 4 is a schematic side sectional view of the electrode side connector 24.
  • the electrode-side connector 24 includes four contact terminals 24a that are electrically connected to the terminals of the main body-side connectors 11 to 14 of the main body 10, and an insulator 24b that supports these contact terminals 24a, as well as a collet 24c and a shell 24d. It has a known configuration consisting of a back nut 24e and a back nut 24e.
  • the contact terminal 24a of the electrode-side connector 24 is a male terminal, but it goes without saying that it may be a female terminal.
  • the electrode cable 25 is composed of a pair of covered compensating conductors 28a and 28b and a cover tube 25a covering the compensating conductors 28a and 28b.
  • the copper compensating lead wire 28a is also used as the lead wire for high-frequency current, thereby simplifying the configuration of the electrode cable 25.
  • the compensating conductors 28a and 28b are connected to the contact terminals 24a by soldering, respectively.
  • the storage device 26 stores information on the electrode 21 (electrode unit 20) and information on temperature measurement by the thermocouple 23 (temperature sensor).
  • the storage device 26 is connected to the contact terminal 24a in the electrode-side connector 24. Therefore, the control unit 10d of the main body 10 communicates with the storage device 26 via the main body side connectors 11 to 14 to read or write information.
  • the empty space in the electrode side connector 24 is effectively utilized. Further, by accommodating the storage device 26 in the electrode side connector 24, it is possible to prevent the shape of the electrode unit 20 from being significantly changed as compared with the case where the storage device 26 is not provided. That is, the storage device 26 can be provided without changing the usability of the electrode unit 20.
  • the storage device 26 is composed of an EEPROM (Electrically Erasable Project Read Only Memory) having only two connection terminals, an input / output terminal 26a that also serves as a power supply terminal and a ground terminal 26b. This makes it possible to provide the storage device 26 while suppressing the increase in size of the electrode-side connector 24 due to the increase in the contact terminals 24a in the present embodiment.
  • EEPROM Electrically Erasable Project Read Only Memory
  • the input / output terminal 26a and the ground terminal 26b are directly connected to the contact terminal 24a by soldering.
  • the storage device 26 can be fixed in the electrode-side connector 24 without separately providing a support member or the like, and the manufacturing cost is reduced.
  • the storage device 26 stores model information, manufacturing lot information, and usage history information as information regarding the electrode 21.
  • the model information and the manufacturing lot information are stored in the storage device 26 at the time of manufacturing the electrode unit 20.
  • the usage history information is stored in the storage device 26 by the control unit 10d every time the high frequency treatment is executed.
  • the usage history information includes information such as the date when the treatment was executed, the treatment mode, and the treatment time.
  • the storage device 26 also stores correction information for correcting a temperature measurement signal (temperature measurement value) as information regarding temperature measurement by the thermocouple 23.
  • This correction information is information for correcting a measurement error due to individual differences in the thermocouple 23 and the compensating conductors 28a, 28b and the like.
  • the measurement error of the temperature measurement is individually measured at the time of manufacture, and the correction information based on the measurement error is stored in the storage device 26.
  • the control unit 10d When executing the high frequency treatment, the control unit 10d first accesses the storage device 26 of the electrode unit 20 connected to the main body side connectors 11 to 14 and acquires model information, manufacturing lot information, usage history information, and correction information. .. Then, based on the model information, the manufacturing lot information, and the usage history information, whether or not the electrode unit 20 is a genuine product, whether or not the model is suitable for the main body 10, and whether or not the expiration date or the usage limit is exceeded. Etc. are judged.
  • control unit 10d determines whether or not the electrode 21 (electrode unit 20) can be appropriately used based on the information about the electrode 21 acquired from the storage device 26. Then, the control unit 10d executes the high frequency treatment only when it is determined that the electrode 21 can be appropriately used. If the control unit 10d also determines that the electrode 21 is not properly usable, the control unit 10d displays an error display on the touch panel display 16a and does not perform high frequency treatment.
  • control unit 10d corrects the temperature measurement signal received from the temperature measurement unit 10c based on the correction information during the execution of the high frequency treatment, and calculates the temperature measurement value. Since the measurement error caused by the individual difference of the thermocouple 23 or the like is canceled by the correction information, the temperature measurement value becomes accurate, so that the output control of the high frequency power is performed with high accuracy. In particular, even when the electrode unit 20 is replaced, the control unit 10d acquires new correction information from the storage device 26 of the replaced electrode unit 20 and performs correction, so that a correction information input operation or the like is required. It is possible to perform highly accurate output control without any problem.
  • the control unit 10d also stores the usage history information in the storage device 26 when the high frequency treatment is completed. By referring to the usage history information stored in this way, it is possible not only to determine the usage limit (life) of the electrode 21, but also to investigate the cause when a defect occurs in the electrode 21. Is possible.
  • the control unit 10d of the main body 10 refers to the information about the electrode 21 stored in the storage device 26, so that the electrode 21 ( It is possible to determine whether or not the electrode unit 20) can be used appropriately. Further, the control unit 10d can correct the temperature measurement value during the treatment and perform output control with high accuracy by using the information regarding the temperature measurement by the thermocouple 23 stored in the storage device 26. ing. That is, according to the electrode unit 20 of the present embodiment, high frequency treatment can be appropriately performed.
  • the electrode 21 may have a blade surface at the tip thereof and may be configured to be able to puncture a human body or the like. Further, the electrode 21 may have a hole at the tip thereof and may be configured to be capable of delivering a chemical solution or the like. Further, a temperature sensor other than the thermocouple 23, such as a resistance temperature detector, may be arranged inside the electrode 21, or a temperature sensor separate from the electrode 21 may be provided and arranged in the vicinity of the electrode 21. You may do so.
  • the electrode cable 25 may be provided with a lead wire for high frequency current separately from the compensating lead wires 28a and 28b.
  • the storage device 26 may be arranged on the outer surface of the electrode side connector 24, or may be arranged in a place other than the electrode side connector 24, for example, in the hub 22 or in the cover tube 25a of the electrode cable 25. It may be what is done.
  • the storage device 26 may be composed of a memory other than the EEPROM, and it goes without saying that the number of terminals included in the storage device 26 and the type of interface are not particularly limited.
  • the storage device 26 and the contact terminal 24a may be connected by a method other than soldering, for example, crimping, or an appropriate connector, socket, or the like may be interposed between the storage device 26 and the contact terminal 24a. You may.
  • the compensating conductors 28a and 28b may be connected to the bridge substrate 27 or the contact terminal 24a by crimping or the like.
  • the electrode unit and the high frequency treatment device of the present invention are not limited to the above-described embodiment, and various changes are made within the range not deviating from the gist of the present invention. Of course it can be added.
  • each part of the high-frequency treatment device 1 is not limited to the shape and arrangement shown in the above-described embodiment, and various known shapes and arrangements can be adopted.
  • the high frequency treatment device 1 is not limited to the one for nerve block, and may be used for other purposes such as cauterization of a tumor.
  • the electrode 21 is not limited to the one inserted inside the human body or the like, and may be arranged on the skin surface of the human body, for example, to heat a relatively shallow area under the skin. Further, the number of electrode units 20 that can be connected to the main body 10 is not particularly limited. Further, the operation switch unit 40 and the processing related thereto may be omitted.
  • High frequency treatment device 10 Main unit (high frequency power generator) 20 Electrode unit 21 Electrode 22 Hub 23 Thermocouple (temperature sensor) 24 Electrode side connector (connector) 24a Contact terminal 26 Storage device 26a Input / output terminal (connection terminal) 26b Grounding terminal (connection terminal) 27 Bridge board 28a, 28b Compensation conductor

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PCT/JP2021/046384 2020-12-25 2021-12-15 電極ユニットおよび高周波処置装置 Ceased WO2022138402A1 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP21910550.9A EP4233754A4 (en) 2020-12-25 2021-12-15 Electrode unit and high frequency treatment device
JP2022572244A JPWO2022138402A1 (https=) 2020-12-25 2021-12-15

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JP2020217768 2020-12-25
JP2020-217768 2020-12-25

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023171164A1 (ja) * 2022-03-10 2023-09-14 株式会社トップ 測温機能付き高周波電極針および熱電対コネクタ
WO2024171779A1 (ja) * 2023-02-16 2024-08-22 株式会社トップ 測温機能付き高周波電極針

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JPH08503381A (ja) * 1991-11-08 1996-04-16 イーピー テクノロジーズ，インコーポレイテッド 絶縁された温度感知素子を有する切除電極
US20010018918A1 (en) * 1999-09-07 2001-09-06 Scimed Life Systems, Inc. Systems and methods for preventing automatic identification of re-used single use devices
JP2002107233A (ja) * 2000-09-27 2002-04-10 Toshiba Corp 熱電対装置
JP2005185829A (ja) * 2003-11-26 2005-07-14 Ethicon Endo Surgery Inc 再使用を制限するためのエネルギー配給装置を伴う医療治療システム
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