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EP2164416A1 - Dispositif destiné à la chirurgie thermique - Google Patents

Dispositif destiné à la chirurgie thermique

Info

Publication number
EP2164416A1
EP2164416A1 EP07786104A EP07786104A EP2164416A1 EP 2164416 A1 EP2164416 A1 EP 2164416A1 EP 07786104 A EP07786104 A EP 07786104A EP 07786104 A EP07786104 A EP 07786104A EP 2164416 A1 EP2164416 A1 EP 2164416A1
Authority
EP
European Patent Office
Prior art keywords
generator
tissue
control unit
frequency spectrum
characteristic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP07786104A
Other languages
German (de)
English (en)
Inventor
Rüdiger STOCKERT
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.)
Stockert GmbH
Original Assignee
Stockert Ruediger
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Stockert Ruediger filed Critical Stockert Ruediger
Publication of EP2164416A1 publication Critical patent/EP2164416A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance

Definitions

  • the invention relates to a device for thermosurgery.
  • thermosurgery biological tissue is heated by applying treatment energy to achieve a particular therapeutic purpose by denaturing the treated tissue.
  • coagulation or ablation of local tissue areas is desired, for example on the inner heart wall of the heart chambers, on the ventricle valves, on the veins connected to the heart and arteries or other blood-carrying vessels of the human or animal body.
  • heart for example, arrhythmias or tachycardias can be treated by means of thermosurgery.
  • the field of application of the thermosurgical device according to the invention is not limited to cardiac treatments. In principle, the device according to the invention is suitable for the thermosurgical treatment of any sites on or within the body.
  • the device according to the invention is in principle not subject to any restriction with regard to the type of heat generation in the treated tissue, be it electrically or by means of other mechanisms of action.
  • tissue impedance changes with tissue temperature.
  • the fabric impedance initially decreases with increasing heating, before the impedance decrease attenuates and the course of the impedance characteristic becomes flat, but then often the tissue impedance jumps up abruptly.
  • it is regularly sought to control the energy input into the tissue so that the tissue impedance remains in the region of its sloping or flattened characteristic branch, but in no case is the steeply rising branch of the impedance characteristic achieved.
  • the object of the invention is therefore to provide a device for thermosurgery, which can reliably avoid unwanted charring or scabbing of the treated tissue.
  • the invention is based on the finding that in biological tissue, when it is heated, microscopic bubbles are formed, which are reflected in the tissue impedance by a characteristic, temperature-dependent varying spectrum.
  • By determining and evaluating the frequency spectrum of the tissue impedance it is thus possible to deduce the current temperature in the treated tissue and, depending on this, control the generator output. Since blistering within the tissue or on the surfaces of applied electrodes is always first to be determined prior to charring or scabbing of the tissue (human or animal tissue consists to a significant extent of an aqueous salt-containing solution, the water contained therein evaporates on heating and in vapor bubbles passes), can be safely avoided by appropriate control of the generator power at the occurrence of bubbles undesirably severe damage to the tissue.
  • About the frequency spectrum of the tissue impedance or, in general terms, an influence of the tissue impedance th or this representative measure can be reliably detect the formation of bubbles and their strength.
  • the operating temperature of the bubble formation is generally above 40 ° C.
  • a direct optical or other registration of these fine bubbles is not or only with difficulty possible with today's medical devices. It must be borne in mind that many procedures are performed without a view of the surgical field, for example in the closed heart chamber or in deep brain regions.
  • the invention takes advantage of the fact that the vapor bubbles affect tissue impedance. Specifically, they are noticeable by fluctuations in the tissue impedance. These fluctuations can be over a
  • the control unit of the thermosurgical device uses the above finding of a relationship between the tissue temperature and the spectrum of the tissue impedance by controlling the energy output of the generator depending on the spectral content of the analyzed variable in a predetermined examination frequency range.
  • the upper limit of the examination frequency range is preferably at most about 5 kHz and at least about 80 Hz, preferably at least about 100 Hz and most preferably at least about 200 Hz.
  • the lower limit of the examination frequency range is preferably at most about 2 Hz and at least at about 1 Hz, preferably at least about 0.5 Hz, and most preferably at least about 0.1 Hz.
  • the frequency spectrum can be re-determined by the control unit continuously or at regular, sufficiently short time intervals.
  • the respective current frequency spectrum is then evaluated by the control unit and - if necessary - converted into corresponding control commands for the generator in order to increase or decrease its output energy.
  • the control unit can do so be configured to determine from the frequency spectrum at least one characteristic spectral parameter of the frequency spectrum of the measured variable, such as a characteristic frequency or a characteristic amplitude.
  • a characteristic frequency may be that frequency at which the frequency spectrum in the examination frequency range has a (local or global) amplitude maximum.
  • a characteristic amplitude may, for example, be the amplitude at such a (local or global) amplitude maximum of the spectrum.
  • control unit may be adapted to reduce the generator power during a treatment operation in response to a decrease in the value of the characteristic frequency or in response to an increase in the value of the characteristic amplitude.
  • a characteristic frequency could be defined as the center frequency of a defined frequency range of the determined frequency spectrum, for example a frequency range in which the frequency spectrum lies above a predetermined amplitude threshold.
  • a characteristic amplitude could, for example, be defined as an amplitude mean value which is obtained by weighted or unweighted averaging of the spectral amplitude in a defined frequency range of the determined frequency spectrum.
  • the at least one characteristic spectral parameter should be defined such that it (or, if several characteristic spectral parameters are defined) shows a temperature-dependent variable pattern, which is a measure of the tissue temperature.
  • the control unit is set up, depending on a plurality of input parameters, at least part of which is characteristic of the determined frequency spectrum, to derive an auxiliary parameter representative of the tissue temperature and to control the energy output of the generator as a function of the value of the auxiliary parameter.
  • the control unit for the derivation of the auxiliary parameter can expediently access stored information about a previously determined relationship between the input parameters and the tissue temperature. For example, this relationship can be obtained empirically by experiment in advance.
  • the stored information may, for example, functionally express the relationship in the form of an algorithm. You can also express it in the form of a table or a set of tables.
  • the input parameters include both a characteristic frequency and a characteristic amplitude of the determined frequency spectrum.
  • the control unit adjusts the energy output of the generator to a predetermined or predeterminable setpoint or a setpoint profile of the auxiliary parameter.
  • control unit is set up to change the energy output of the generator, in particular in steps, as a function of the puncturing of at least one predetermined threshold of the auxiliary parameter.
  • control unit may switch off the generator at least temporarily if a limit temperature of the tissue indicated by a corresponding threshold is exceeded.
  • the frequency spectrum of the measured variable may depend on other influencing factors in addition to the tissue temperature.
  • the input parameters from which the control unit determines the auxiliary parameter can therefore, in addition to the at least one characteristic spectral parameter of the determined frequency spectrum, additionally comprise one or more further parameters, which are representative of the other influencing factors mentioned above and not derived from the determined spectrum.
  • One of the influencing factors may be in particular the air pressure.
  • the prevailing air pressure can have a considerable influence on the formation of bubbles and thus on the impedance spectrum.
  • the partial pressure of the vapor bubbles in the biological tissue varies with the external pressure (air pressure).
  • a high external pressure shifts the temperature threshold, from which the formation of bubbles begins, upwards.
  • a lesser external pressure allows the formation of steam bubbles even at considerably lower temperatures.
  • the control unit can receive from a pressure sensor a sensor signal representative of the measured air pressure. It is also conceivable that the user can manually set an air pressure value on the device and the control unit uses the air pressure value preset by the user.
  • Correction factors can also be provided, for example, for influencing factors such as the type of tissue or as the position and / or the type of electrode via which an electrical signal used to determine the measured variable is tapped on the body.
  • influencing factors such as the type of tissue or as the position and / or the type of electrode via which an electrical signal used to determine the measured variable is tapped on the body.
  • the vapor bubbles can behave differently in heavily perfused tissue than in comparatively hard tissue layers.
  • at Skin or surface electrodes may give different readings than on passive measuring electrodes for electrophysiological signals or on active radiofrequency electrodes with which an electrical AC voltage is applied to the tissue during HF surgery.
  • control unit may be configured to bring the determined frequency spectrum or at least one derived therefrom size on a display unit for visual display. This allows the surgeon to carry out a self-checking of the course of treatment and, if necessary, to adapt the emitted generator power via suitable operating elements on the device according to the invention.
  • FIG. 1 shows an exemplary, purely qualitatively to-be-understood time profile of a voltage measurement signal in which fluctuations which are attributable to the formation of vapor bubbles in the tissue during a thermosurgical application
  • FIG. 2 schematically and again purely qualitatively the changing frequency spectrum of the tissue impedance with increasing heating of the tissue
  • FIG. 3 schematically shows a block diagram of an embodiment of a thermosurgical device according to the invention
  • FIG. 4 shows components of a measuring amplifier of the device of FIG. 3.
  • FIG. 1 shows a typical electrophysiological voltage signal which can be tapped on a living body.
  • the voltage signal can be tapped on the application part of a cardiac catheter, on internal lead-in electrodes of such a cardiac catheter, on ECG electrodes or reference electrodes mounted on the outside of the body, or on a counterelectrode.
  • the diagram of Figure 1 illustrates the variations in the voltage amplitude, which are observable in the course of the thermosurgical treatment of the body due to vapor bubble formation in the tissue and concomitantly by a change in the tissue impedance.
  • Phase 1 marks the beginning of the energy input into the tissue; in the voltage measurement signal are still no deflections recognizable.
  • Phase 1 marks the beginning of the energy input into the tissue; in the voltage measurement signal are still no deflections recognizable.
  • Phase 2 shows the formation of vapor bubbles. It manifests itself in the voltage measurement signal due to comparatively weak voltage fluctuations. The fluctuations occur relatively quickly, i. they have a relatively high frequency.
  • phase 2 in the diagram of FIG. 1.
  • Phases 3 and 4 in the diagram of FIG. 1 illustrate this increase in the fluctuation strength with simultaneously decreasing frequency of the voltage changes.
  • FIG. 2 once again illustrates in purely qualitative terms the associated spectrum of the voltage signal in the frequency range relevant for vapor bubble formation.
  • This frequency range extends, for example, from 0.5 Hz to about 200 Hz, although the upper and lower limits of the frequency range examined can of course be chosen differently in the specific application.
  • the spectrum of the changes in the tissue impedance caused by the vapor bubble formation and thus the voltage fluctuations of the measurement signal with little tissue heating is denoted by Si in FIG Spectrum with strong heating with S 2 is designated and in contrast to the spectrum at low warming is indicated only by dashed lines.
  • the spectral envelopes shown in FIG. 2 are only to be understood as examples; in concrete cases, the spectra can show a different form. What is important is simply the fact that with increasing warming, a shift of the spectrum takes place towards lower frequencies, while at the same time the spectral amplitude becomes larger. This behavior is illustrated in FIG. 2 by a shift arrow P pointing in the direction of smaller frequencies and to larger spectral amplitudes.
  • the temperature-dependent shift of the tissue impedance spectrum is used according to the invention to control the energy input into the tissue.
  • the generator power can be reduced before the spectrum migrates too low to small frequencies, so as to avoid burns and scabbing of the tissue.
  • spectral parameters are particularly suitable for the characterization of the spectral content of the tissue impedance spectrum, namely the frequency of the strongest amplitude (identified in FIG. 2 as f 0 ) and the maximum spectral amplitude (characterized by A 0 ).
  • a biological tissue 20 is indicated, into which a coagulation or non-detailed detail is shown.
  • Ablation instrument is introduced. Via the instrument and an electrode arrangement provided on the instrument, an electrical alternating voltage is applied to the tissue 20 by a high-frequency generator 22.
  • the frequency of the AC voltage used for the tissue treatment in the three-digit kHz range up to the single-digit MHz range. For example, it is about 200 kHz or about 500 kHz.
  • the AC treatment voltage is applied between two electrodes attached to the inserted instrument tip; in the case of monopolar instruments, only the application electrode is located at the tip of the instrument; the counterelectrode is located on the outside of the surface of the treated body.
  • the invention is generally independent of the type of instrument used and also the type of treatment energy introduced, be it electrical energy, electromagnetic energy, optical energy or acoustic energy.
  • sensors 24 which each pick up an electrical measuring voltage via an electrode mounted on the inside or outside of the body, bandpass filters and amplify it and amplify the measurement signal thus obtained to an electronic control unit 26 deliver.
  • a total of four sensors 24 are shown.
  • each of the active RF electrodes via which the treatment AC voltage of the generator 22 is fed into the tissue 20 (application electrode and indifferent or neutral electrode), each a sensor 24 is connected; These are usually the primary places of heat generation.
  • the number of sensors 24 is of course variable at any time. It can be enough to tap only a single measuring voltage on the body.
  • each of the sensors 24 has as functional components a low-pass filter 28, a high-pass filter 30 and a subsequent amplification module 32.
  • the two filters 28, 30 together cause a bandpass filtering of the measurement signal, wherein the passband is for example between about 0.5 Hz and about 200 Hz. According to current knowledge, the relevant part of the spectral components associated with vapor formation occurs in this area.
  • the control unit 26 determines a frequency spectrum for each of the band-pass filtered and amplified measurement signals, for example by Fourier analysis or other suitable spectral investigation methods. For each frequency spectrum determined in this way, it determines the current values of the spectral parameters f 0 and Ao and, depending thereon, determines an auxiliary parameter which is a measure of the strength of the vapor bubble formation that has flowed into the relevant measurement signal and thus a measure of the tissue temperature in the region where the relevant measurement signal was tapped on the body. To determine the auxiliary parameter, the control unit 26 can resort to further input parameters, in particular to a current value of the air pressure supplied by a pressure sensor 34.
  • a memory 36 connected to the control unit 26 contains in tabular or algorithmic form information about the relationship between the auxiliary parameter and all input parameters including the spectral parameters fo, Ao and the air pressure. Depending on the auxiliary parameter determined in this way, the control unit 26 then controls the output power of the generator 22 in accordance with a control program.
  • a setpoint profile of the auxiliary parameter suitable for the respective treatment can be stored in the memory 36, to which the control unit 26 controls the power control of the generator 22 adjusts the auxiliary parameter.
  • one or more thresholds may be stored in the memory 36, below or below which the control unit 26 changes the generator power in a stepwise manner. It is understood that the actual tax method may depend on the type of treatment.
  • thermosurgical device may be open to manual generator control.
  • a display unit 38 can be connected to the control unit 26, on which the control unit 26 can effect a graphic or numerical display of the determined frequency spectrum or at least of the characteristic spectral parameters of the spectrum. It is conceivable Also, that the control unit 26 on the display unit 38 can cause the display of a derived from the determined frequency spectrum and optionally other input parameters temperature measure, which is representative of the estimated tissue temperature. Based on the through the display unit
  • thermosurgical device ie with display of suitable information on the display unit 38 to enable manual power regulation of the generator instead of automatic power control
  • suitable controls not shown.
  • the thermosurgical device of FIG. 3 may additionally include a constant voltage or constant current source (not shown) which provides a stabilized DC voltage or a stabilized DC current, respectively.
  • This DC voltage or DC current is fed into the tissue 20. In this way it can be ensured that with a possible subtraction of all electrochemical voltages of the body, however, a sufficient voltage swing for the vapor bubble-induced voltage fluctuations is possible.
  • this external voltage or current supply is such that it has no electrophysiological effects on the biological tissue.
  • the thermosurgical device may include an AC power source (also not shown) which provides a constant alternating current whose frequency is different from the frequency of the AC treatment voltage of the generator 22. This alternating current is fed into the tissue 20. On the body, an alternating voltage can then be tapped whose amplitude is modulated in accordance with the bubble-induced changes in the tissue impedance. By envelope demodulation of the AC voltage thus tapped, a measurement signal representative of the tissue impedance can be obtained, which can then be subjected to spectral analysis in the manner described above.
  • an AC power source also not shown
  • This alternating current is fed into the tissue 20.
  • an alternating voltage can then be tapped whose amplitude is modulated in accordance with the bubble-induced changes in the tissue impedance.
  • envelope demodulation of the AC voltage thus tapped a measurement signal representative of the tissue impedance can be obtained, which can then be subjected to spectral analysis in the manner described above.
  • the frequency of this additional "measuring alternating current" fed into the tissue for impedance measurement purposes can be selected within a wide range as long as it is sufficiently different from the frequency of the treatment changes.
  • the voltage of the generator 22 is so that the voltage response of the body can be discriminated to the excitation by the AC measurement current from the AC treatment voltage.
  • the frequency of the measurement alternating current can be selected in a range ranging from about 5 kHz to about 10 MHz.
  • typical frequencies of the measuring alternating current for example 50 kHz or 100 kHz can be mentioned.
  • the frequency of the measuring alternating current may be smaller or larger than the frequency of the treatment alternating voltage.
  • the phase shift between the injected measuring alternating current and the tapped AC voltage response can be used.
  • the phase angle of the two oscillations changes. This can be determined by the control unit 26 and evaluated also spectrally.
  • the tissue impedance could be determined directly from the quantities voltage and current of the RF energy emitted by the generator 22 (for example ratio of the rms values, relative phase position). In this case, can be dispensed with a separate measuring alternating current, which has a favorable effect on the cost of the thermosurgical device.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif destiné à la chirurgie thermique de tissu biologique comprenant un générateur (22) pour fournir de l'énergie de traitement, un moyen de mesure (24) pour la détection de l'évolution temporelle d'une grandeur de mesure influencée par l'impédance du tissu du corps traité ou représentative de l'impédance du tissu, et une unité de commande (26) servant à déterminer un spectre de fréquences pour l'évolution temporelle de la grandeur de mesure dans une gamme de fréquences d'examen prédéterminée et à commander la fourniture d'énergie du générateur (22) dans la gamme de fréquences d'examen en fonction de la teneur spectrale de la grandeur de mesure. L'invention est basée sur le fait que la formation de bulles de vapeur dans le tissu chauffé peut être reconnue à l'aide du spectre de fréquences de l'impédance du tissu, notamment dans une gamme de fréquences entre environ 0,5 Hz et 200 Hz. Selon l'étendue de la formation de bulles de vapeur, l'impédance de tissu présente une image spectrale différente à l'intérieur de cette gamme de fréquences. Ce fait est, selon l'invention, utilisé pour la commande de la fourniture de l'énergie du générateur.
EP07786104A 2007-07-16 2007-07-16 Dispositif destiné à la chirurgie thermique Withdrawn EP2164416A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2007/006302 WO2009010080A1 (fr) 2007-07-16 2007-07-16 Dispositif destiné à la chirurgie thermique

Publications (1)

Publication Number Publication Date
EP2164416A1 true EP2164416A1 (fr) 2010-03-24

Family

ID=38537697

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07786104A Withdrawn EP2164416A1 (fr) 2007-07-16 2007-07-16 Dispositif destiné à la chirurgie thermique

Country Status (3)

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US (1) US8361064B2 (fr)
EP (1) EP2164416A1 (fr)
WO (1) WO2009010080A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9179972B2 (en) 2012-05-04 2015-11-10 St. Jude Medical, Atrial Fibrillation Division, Inc. System and method for controlling delivery of ablation energy to tissue
US20210361339A1 (en) * 2020-05-21 2021-11-25 Covidien Lp Independent control of dual rf monopolar electrosurgery with shared return electrode
US20210361340A1 (en) * 2020-05-21 2021-11-25 Covidien Lp Independent control of dual rf electrosurgery
DE102020208935A1 (de) 2020-07-16 2022-01-20 Robert Bosch Gesellschaft mit beschränkter Haftung Elektrochirurgisches Instrument und Verfahren zur Untersuchung von mittels des elektrochirurgischen Instruments gegriffenem Gewebe

Family Cites Families (7)

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Publication number Priority date Publication date Assignee Title
US3812858A (en) 1972-10-24 1974-05-28 Sybron Corp Dental electrosurgical unit
DE2730038C2 (de) 1977-07-02 1983-12-29 Robert Bosch Gmbh, 7000 Stuttgart Selbstheilender elektrischer Kondensator
DE3120102A1 (de) 1981-05-20 1982-12-09 F.L. Fischer GmbH & Co, 7800 Freiburg Anordnung zur hochfrequenzkoagulation von eiweiss fuer chirurgische zwecke
DE4126607C2 (de) * 1991-08-12 2003-10-09 Storz Karl Gmbh & Co Kg Anordnung zum Schneiden von biologischem Gewebe mit Hochfrequenzstrom
AU2001279026B2 (en) 2000-07-25 2005-12-22 Angiodynamics, Inc. Apparatus for detecting and treating tumors using localized impedance measurement
DE10102254A1 (de) * 2001-01-19 2002-08-08 Celon Ag Medical Instruments Vorrichtung zur elektrothermischen Behandlung des menschlichen oder tierischen Körpers
US7300435B2 (en) * 2003-11-21 2007-11-27 Sherwood Services Ag Automatic control system for an electrosurgical generator

Non-Patent Citations (1)

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Title
See references of WO2009010080A1 *

Also Published As

Publication number Publication date
WO2009010080A1 (fr) 2009-01-22
US8361064B2 (en) 2013-01-29
US20100211062A1 (en) 2010-08-19

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