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WO2013139945A1 - Dispositif et procédé destinés à mesurer et réguler des effets thermiques dans le domaine de la chirurgie haute fréquence - Google Patents

Dispositif et procédé destinés à mesurer et réguler des effets thermiques dans le domaine de la chirurgie haute fréquence Download PDF

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Publication number
WO2013139945A1
WO2013139945A1 PCT/EP2013/056001 EP2013056001W WO2013139945A1 WO 2013139945 A1 WO2013139945 A1 WO 2013139945A1 EP 2013056001 W EP2013056001 W EP 2013056001W WO 2013139945 A1 WO2013139945 A1 WO 2013139945A1
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WO
WIPO (PCT)
Prior art keywords
effect zone
neutral
measuring
electrical resistance
electrical
Prior art date
Application number
PCT/EP2013/056001
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German (de)
English (en)
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WO2013139945A9 (fr
Inventor
Günter Farin
Original Assignee
Farin Guenter
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 Farin Guenter filed Critical Farin Guenter
Priority to DE112013001594.3T priority Critical patent/DE112013001594B4/de
Publication of WO2013139945A1 publication Critical patent/WO2013139945A1/fr
Publication of WO2013139945A9 publication Critical patent/WO2013139945A9/fr

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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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/16—Indifferent or passive electrodes for grounding
    • 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
    • A61B18/1233—Generators therefor with circuits for assuring patient safety
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482—Digestive system
    • A61B2018/00494—Stomach, intestines or bowel
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00529—Liver
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • 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
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • A61B2018/141—Snare
    • 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
    • A61B18/16—Indifferent or passive electrodes for grounding
    • A61B2018/165—Multiple indifferent electrodes

Definitions

  • high-frequency electrical alternating currents can generate thermal effects in biological tissues of patients. These effects can be used, for example, for cutting, devitalizing and / or closing blood vessels or for hemostasis.
  • the invention relates to methods and devices suitable or even required for this, with which the thermal effects can be better controlled, controlled and / or regulated in monopolar HF surgical methods.
  • Surgically useful thermal effects in target tissues are, in particular, the devitalization effect above about 50 ° C., the coagulation effect above about 60 ° C., the desiccating effect, which takes place especially when the boiling temperature of intracellular and extracellular fluids is reached, and the so-called vaporization effect or the pyrolysis from about 200 ° C.
  • target tissue tissue on or in which at least one of the above thermal effects is to be generated.
  • the heating of the target tissue to the temperature required to produce the respective intended thermal effects is achieved by endogenous and / or exogenous conversion of electrical energy into thermal energy. With endogenous conversion, the conversion of electrical energy into thermal I mean energy in the tissue.
  • HF current flows between an active electrode applied to the target tissue and a neutral electrode applied generally on the skin of the patient, ie both through target tissue and through collateral tissue
  • the conversion takes place both in the target tissue and in the collateral tissue instead of.
  • exogenous conversion here is meant the conversion of electrical energy into thermal energy outside of the target tissue, in particular in the directed to the respective target tissue electrical arcs or gas plasmas.
  • U H Feff is the rms value of the RF voltage applied to the respective tissue
  • l H Feff the rms value of the HF current flowing through the respective tissue
  • R T the amount of electrical resistance of the tissue in question (Tissue)
  • At e ff the effective duration of the HF current means.
  • the RF current is known to be directed through relatively small-area contacts between an active electrode or an electric arc or plasma beam and the respective target tissue in the target tissue, such that the HF current divergent depending on the viewing direction of the small-area contact out into the tissue or convergent flows out of the tissue in the small-area contact.
  • the current density consequently decreases with the distance from the small area contact. Since the heating of the fabric is proportional to the square of the current density, the heating of the fabric takes place more rapidly in the contact-near zone than in the contact-distant zone. Incidentally, this is a requirement of monopolar RF surgical procedures and context of the subject of this invention.
  • a further object of the invention is to develop devices and methods for detecting, controlling, adjusting, controlling and / or regulating electrical parameters at and / or in the effect zone of target tissues in monopolar applications of HF surgery.
  • the intended thermal effects should not and / or not occur simultaneously at all sites or in all zones of a target tissue and do not actually do so, but generally arise at the site or in the zone of the target tissue, which is contacted by the active electrode and in which the current density for generating the respective intended thermal effects is sufficiently large.
  • the zone of the target tissue in which the intended thermal effects are to be generated or generated is referred to below as the effect zone (EZ Effect Zone).
  • the RF current thus flows successively through the effect zone and through the tissue adjacent to the effect zone, which is referred to below as collateral tissue (CT / collateral tissue), to the neutral electrode.
  • R EZ is the electrical resistance of the Effekzone between the surface or interface through which the HF current from the active electrode coming into the Ef
  • zone of influence refers to the interface between the effect zone and the collateral tissue through which the HF current flows out of the effect zone.
  • R CT is the electrical resistance of the collateral tissue between the interface to the effect zone into which the RF current from the effect zone flows into the collateral tissue and the contact surface between collateral tissue and neutral electrode through which the RF current flows out of the collateral tissue. meant.
  • R L is the electrical resistance that can be measured between the electrical connections of the active electrode and the neutral electrode, that is to say the sum of R E z and R CT .
  • resistors R E z and RCT and consequently also R L do not remain constant during an operation but vary more or less.
  • the magnitude of the effect zone R EZ of the effect zone increases and decreases in particular with the effective magnitude A eff and shape of the contact area between the active electrode and the effect zone, and also with the temperature of the fabric of the effect zone.
  • the amount of resistance RCT depends in particular on the electrical properties of the skin and the subcutaneous fatty tissue and on the effective contact surface of the neutral electrode with the skin of the patient.
  • the neutral electrode should therefore be applied to the skin of the patient so that as much as possible of the contact surface available on a neutral electrode is electrically conductively contacted with the skin of the patient and remains contacted during the operation. To ensure this are high-frequency surgical devices with Control devices equipped to automatically control the electrical contact between the neutral electrode and the patient.
  • Such a control device is known for example from European Patent EP 0 390 937 Bl.
  • the purpose of these and other known devices for controlling the application of neutral electrodes is not the direct measurement or indirect determination of R CT - these devices are not provided for this because the above-defined resistance R CT has not previously been considered, nor readily for this purpose suitable.
  • a device (A) which comprises
  • a device for switching the connections between the neutral electrodes and / or the active electrode and the device for measuring the electrical resistance of biological tissues and
  • This device (A) may be an integral part of a high-frequency surgical device or a separate device for combined use for a high-frequency surgical device.
  • This device may be applied to or in high frequency surgical devices to control, control, regulate, and / or display electrical parameters at and / or in the effect zone, and / or to derive information about the state of the tissue in the effect zone therefrom.
  • the amount of resistance R E z may be less than the amount of resistance R CT .
  • R EZ can be determined in vitro and sufficiently well by, as shown schematically in FIG. 6, two identical of the respective active electrodes to be used (AE1, AE2) on or in the respective target tissue identical or comparable to specific electrical resistance at normal body temperature tissue comparable (T / Tissue) are applied in this optimal distance from each other and the electrical resistance between these two active electrodes is measured at the terminals (A AE i, A AE2 ) and then divided by 2.
  • optimal distance is here meant a distance at which the configuration of the electric field in the vicinity of the two identical active electrodes corresponds to that in real application on or in the goat tissue and these two near fields touch each other as directly as possible in the median surface (MP).
  • the electrical resistance R EZ i + R E z2 # is, for example, between a customary polypectomy snare and a polyp with one at the application parts of the polypectomy snare (eg AE1). measured diameter (d) of 1 cm at normal body temperature about 25 ohms.
  • d measured diameter
  • the specific electrical resistance of electrolytes decreases reciprocally in proportion to the temperature of the electrolyte-containing tissue.
  • a temperature increase from approx. 35 ° C to approx. 90 ° C reduces the specific electrical resistance of biological tissues by about half, in the above example in the polypectomy the resistance RJJ thus drops from 25 ohms at 35 ° C to approx Ohm at 90 ° C.
  • FIG. 1 shows the application of simultaneously at least two neutral electrodes to a patient to determine the amount of R CT or RCT p and the amount of R L or R Lp
  • FIG. 2 shows an exemplary embodiment of an apparatus for in vivo measurement of RNEI / NE2 and R L or R Lp and for calculating R CT or R CT P and R EZ from the measurement results
  • FIG. 3 shows an exemplary embodiment of a device for controlling the application of neutral electrodes to the patient and for in vivo measurement of RNEI / NE2 and R L or R Lp and for calculating R CT or R CT p and R EZ from the measurement results and for checking , Control, and / or display of the electrical parameters on and / or in the effect zone and / or the state of the tissues in the effect zone and / or on and / or Kollatera lgewebe and / or the state of application of the neutral electrodes on patients.
  • Figure 6 is a graph for describing a method for in vitro measurement of R E z when using certain active electrodes on certain target tissues.
  • FIG. 7 is a graph describing the postulate listed above and the definitions introduced there.
  • FIG. 8 shows the applicability of the device shown in FIG. 3 also for two single-surface neutral electrodes.
  • the above-described postulate as well as the above-mentioned definitions which are the basis of this invention can be explained with reference to FIG.
  • a patient (P) largely reduced to the essentials, shown.
  • a neutral electrode (NE) with a connecting cable (K NE ) is applied on the skin (H) of the patient P.
  • An active electrode (AE) is applied to a target tissue (TT) to produce a thermal effect at that site of the target tissue by introducing an RF current (I H F).
  • the RF current flows from the active electrode (AE) divergent into the target tissue (TT) and further diverging through the collateral tissue (CT) to the neutral electrode (NE).
  • AE active electrode
  • CT collateral tissue
  • NE neutral electrode
  • R E z the electrical resistance of the effect zones EZ, ie the electrical resistance of the tissue between the active electrode AE and the imaginary interface between effect zone EZ and target tissue TT or collateral tissue (CT) to which the target tissue belongs or know in vivo.
  • R EZ can be determined in vivo as the difference between R L and R CT , if the electrical resistance of the tissues between the active electrode and the neutral electrode, which is known as the load resistance R L and is directly measurable in vivo, and the electrical resistance R CT collateral tissue CT, dominated by subcutaneous fat tissue (FT) in particular, knows what is rarely the case or identifies what has not been possible so far. How this can now be done in vivo will be described with reference to FIG.
  • the amount of electrical resistance R CT or R CTp can be measured and determined in vivo indirectly and with sufficient accuracy, as shown in FIG shown schematically, at least one neutral electrode (N E1, NE2) as symmetrical, in particular mirror-symmetric and equidistant to the sagittal plane SP (Sagittal Plane) is applied to the patient P, for example, each a neutral electrode on the left and one on the right thigh of the patient th, if the target tissue TT lies in the lower region of the body, or one neutral electrode on the left and one on the right upper arm when the target tissue TT is in the upper region of the body (not shown in FIG.
  • RCTP parallel resistor
  • the electrical resistance of the effect zone in the endoscopic polypectomy of a polyp with a diameter of 1 cm at normal body temperature only about 25 ohms and at 100 ° C, ie the temperature the EZ, which is achieved in HF surgical cutting in the effect zone, only about 15 ohms.
  • the method by which these resistances were measured in vitro is shown and described as an intermediate reference with reference to FIG. 6 in the following paragraph.
  • the method shown schematically in FIG. 6 for the in-vitro determination of R EZ can be used with any resistance or impedance measuring device with which the electrical resistance of electrolyte-containing biological tissue can be measured.
  • two identical active electrodes AE1 and AE2 are applied at a slight distance from each other around a polyp-like and polyp-like tissue, and the amount of electrical resistance of the tissue between these two active electrodes is measured at the respective tissue temperatures of interest.
  • This in vitro method can, of course, be applied to various types of tissue and with different active electrodes and also at different tissue temperatures and tissue conditions and is also suitable for checking the in vivo method according to the invention.
  • the neutral electrodes should be properly applied to the patient with regard to the smallest possible amount of the resistance R CT p and remain during the entire treatment period.
  • the inventive method takes advantage of the fact that the relative dependence of the resistance change AR N E / SP of the change AA eff the effective contact area A eff on a partial contact surface, eg A
  • SP sagittal plane
  • the amount of resistance R CT P thus determined is not limited, as shown in FIG. 1, to effect zones which are located precisely in the sagittal plane (SP), but also largely applicable to effect zones located outside the sagittal plane, because the parallel connection resistors RNEI / EZ and RNE2 / EZ sufficiently compensate the unbalanced localization of EZ.
  • a device suitable for this purpose consists, as shown schematically in FIG. 3, of a measuring device (10) for measuring, for example, the electrical resistances Ri a / 2a-Ria / 2b # Rib / 2a and Rib / 2b between the part contact surfaces (FIG.
  • R U: I from a measured voltage (U) and a measured current (I) a measuring device for measuring the electrical resistances, here between the contact surfaces of neutral electrodes and / or their partial contact surfaces, as known for example from the patent EP 0 390 937, from a voltage source and a current sensor, the one of the amount of the respective resistance or the Control current influenced by it (1 k ) provides proportional electrical signal.
  • U k const.
  • the control current I k is directly proportional to the resistance R.
  • CPU central processing unit
  • Suitable hardware and software for this purpose are known to the person skilled in the art, so that a description thereof appears to be dispensable.
  • This device can be replaced by additional switch (fl, f2), with which the active electrode (AE) can be connected either to the HF generator (15) or to the measuring device.
  • tion (10) can also be used to measure the so-called load resistance (R L ) and thus also as follows to calculate R EZ as a difference of R L and RCT or R CT p:
  • the amount of R EZ can also be determined in vivo both before activation, as well as in pauses or interruptions of the activation of the RF generator. This results in the possibility of the amount and / or changes in the amount of electrical resistance R EZ the effect zone of the target tissue before, during interruptions and / or after the activation of the RF generator or before, during interruptions and / or after the application To control electrical energy in the target tissue and to derive conclusions about the state or to changes in the state of the tissue in the effect zone of the target tissue.
  • This device shown in FIG. 3 can be further configured as follows. For example, the measured resistances Ri a / 2a-Ria / 2b # Rib / 2a and Rib / 2b or R L, etc., and determined resistances such as R CT or R CT P and / or R EZ or results of the evaluation of these resistors or even
  • the processor CPU
  • the processor can also be used to generate display (m), warning (s) and / or condition signals (o), the Display devices (16), warning devices (17) and / or Statea display devices (18) are passed.
  • Display devices (16) can be, for example, alphanumeric or graphic displays.
  • Warning devices (17) may be, for example, acoustic and / or visual warning signals generating elements.
  • Status indicators (18) may be, for example, graphic displays or monitors.
  • the processor may also be used to generate control signals (r, s) for controlling, in particular, the rf generator (15) and / or the o.g. Switch (a, b, c, d, e, f) are used when the switches, for example, by relays (A, B, C, D, E, F, not all shown in Figure 3) are realized, in a specialist In the field of electrical engineering known manner and therefore briefly as a block (19) shown assembly are summarized and need not be described in more detail.
  • this device can additionally be equipped or operated with software programs (20) for controlling, controlling and / or regulating the electrical parameters in or on the effect zone, for automatically controlling the resistance measurements and activations of the HF generator etc.
  • this device can also be designed so that they can also be operated as conventional control devices with only a two-surface neutral electrode or with one or two single-surface neutral electrodes ,
  • the connection sockets 21, 22, 23, 24 are designed such that only one single-surface neutral electrode (FIG. 4) or only one double-surface neutral electrode (FIG. 5) or two single-surface neutral electrodes (FIG. 8) are connected to the connection sockets, for example 22 and 23 are connectable.
  • this device offers even more connection and / or combination options of neutral electrodes and their connection to this control device.
  • a well-known problem of monopolar methods of HF surgery is the unsatisfactory control and reproducibility of each intended in the effect zone of a target tissue, as well as the avoidance of each in the target tissue or in the effect zone and / or in the collateral tissue unintentional thermal effects.
  • various known monopolar methods of HF surgery can be improved and as follows new methods are developed, for example, the development of a method and a device suitable for this purpose for setting and / or automatic control or regulation of the setpoint U E zsoii the RF voltage at the effect zone.
  • : (R L - R CT p) ' R L U EZso n: R EZ ' R L or by manual adjustment and / or automatic control of the HF output current (l G ) of the HF generator, for example, according to the function
  • a target tissue or into an effect zone can also be realized.
  • _ " RCT). be done ' ⁇ l Ge ff 2' R EZ ' ⁇ t e ff in such a manner that the effective value l Eze ff of the RF current I DC, the resistance R DC of the effect zone EZ and the effective duration of current flow ⁇ t e measured ff and in accordance with this function is calculated.
  • the effective value l Eze ff of the RF current I DC which is identical to the effective value l Ge ff of the RF output current I G of the RF generator G, and the effective duration of current flow ⁇ t e ff can as required as a parameter on HF generator or a device provided for this purpose are manually set on or in the HF generator and / or, for example, manually or automatically controlled as a function of other parameters
  • a desired amount E EZso n of electrical energy E required to produce intentional thermal effects in an effect zone can also correspond to the function
  • EEZSOII (U G eff: L) 2 ' REZ ' At e ff done in such a way that the effective value U Ge ff of the RF output voltage U G of the RF generator 15, the resistance R EZ of the effect zone EZ and the effective Current flow time et e ff et measured and E EZso n calculated according to this function.
  • the effective value U Ge ff of the RF output voltage U G of the RF generator 15 and the effective duration of current flow ⁇ t e ff can be adjusted manually according to requirements as parameters at the RF generator 15 or use a dedicated device on or in the RF generator and / or For example, be controlled manually or automatically depending on other parameters.
  • a further embodiment of the invention relates to the use of the device described above according to FIG. 3 for a method and device suitable therefor for setting and / or automatically controlling or regulating the setpoint value UEZsetpoint of the HF voltage at the effect zone.
  • UG U EZS0
  • Another aspect of the invention relates to the use of the device described above according to FIG. 3 for a method and a device suitable for this purpose for the controlled application of electrical energy, a target tissue or an effect zone.
  • Controlled application of the dose or desired quantity E EZSO II of electrical energy (E) required to produce beaten thermal effects in a target tissue or an effect zone of a target tissue can be carried out, for example, according to the function
  • the effective value of l Eze ff of the RF current I DC which is identical to the effective value l Ge ff of the RF output current I G of the RF generator G, and the effective duration of current flow At eff can as needed as a parameter to the HF-generator or
  • a device provided for this purpose can be set manually on or in the HF generator and / or manually or automatically controlled, for example, depending on other parameters.
  • the controlled application of a desired amount E EZS oii of electrical energy E required for the production of intended thermal effects in an effect zone can, for example, also correspond to the function
  • the effective value U Ge ff of the RF output voltage U G of the RF generator 15 and the effective duration of current flow ⁇ t e ff can be adjusted manually according to requirements as parameters at the RF generator 15 or use a dedicated device on or in the RF generator and / or For example, be controlled manually or automatically depending on other parameters.
  • a further aspect of the invention relates to the use of the device described above according to FIG. 3 for a method and a device suitable therefor for checking REZ and, in particular, for the automatic disconnection of the HF current or the HF generator upon reaching a setpoint value or one defined state or a defined change of REZ.

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Abstract

L'invention concerne un dispositif et un procédé permettant de déterminer la résistance de la zone d'effet dans la chirurgie haute fréquence monopolaire. Cela permet de mesurer et de réguler les effets thermiques dans le domaine de la chirurgie haute fréquence.
PCT/EP2013/056001 2012-03-21 2013-03-21 Dispositif et procédé destinés à mesurer et réguler des effets thermiques dans le domaine de la chirurgie haute fréquence WO2013139945A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE112013001594.3T DE112013001594B4 (de) 2012-03-21 2013-03-21 Vorrichtung und Verfahren zur Messung und Regelung thermischer Effekte bei der Hochfrequenzchirurgie

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EP12160649.5 2012-03-21
EP12160649 2012-03-21

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WO2013139945A9 WO2013139945A9 (fr) 2013-12-05

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