RU2840667C2 - Test device and method for calibrating analysing device for analysing light effects caused by operation of high-frequency surgical instrument, and system for high-frequency surgical intervention on biological tissue - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: test device (TE) for testing, particularly calibration, of an analysing device (AE) for analysing light effects caused by operation of a high-frequency surgical instrument. Testing device (TE) comprises a test device configured to create a test plasma light effect, light from which is received by a light detector. Method of testing, in particular calibration of an analysing device (AE) for analysing light effects generated by a high-frequency surgical instrument. Method includes creation of test light effect between test device and electrode. Light from this test light effect is received by the light detector. Method is preferably implemented by a surgical team member, particularly a surgeon or a surgical assistant.

EFFECT: use of present group of inventions improves solution for operation of system with analysing device intended for analysis of light effects caused by operation of high-frequency surgical instrument.

16 cl, 7 dwg

Description

The invention relates to the field of analysis of light effects caused by electrosurgical action on tissue.

In a paper published in the scientific journal Biomedical Optics Express, Spether et al., titled “Real-time tissue differentiation based on optical emission spectroscopy for guided electrosurgical tumor resection,” describe a preclinical study that examined the light effect created between a tissue sample taken from a surgically removed patient organ and an instrument.

From the publication EP 2 659 846 A1 a surgical device with an instrument for acting on biological tissue, accompanied by a light effect, is known. The known device comprises an analyzing device for determining the characteristics of light arising as a result of acting on biological tissue, and a discriminator device for correlating the characteristics of this light with the characteristics of the biological tissue subjected to the action. In the publication EP 2 659 846 A1 it is proposed to store in a database reference spectra or characteristic characteristics of light from healthy and diseased tissue, different types of tissue, etc. Such a database can be filled with the corresponding data statically, i.e. before the start of the operation. It is also possible to obtain or subsequently correct the data before the operation or during the operation. For example, a variant can be envisaged in which the surgeon, being sure that he is making an incision in a certain tissue (for example, in healthy tissue), stores in memory as a specified value at least one characteristic of the light emitted in this case. Deviations from this specified value that are subsequently detected can be recorded by the discriminator device to generate a corresponding signal. The device can subject this signal to subsequent processing and transmit it. In general, it can be said that the discriminator device compares preset or patient-specific reference spectra or individual features of these spectra with the measured spectrum or its individual features and, based on the differences between the compared values, generates signals indicating a change in the type or structure of the tissue. Patient-specific light features, such as the patient-specific reference spectrum, can be recorded and stored at the beginning of the operation, as well as once or repeatedly during the operation.

Publication US 2009/0088772 A1 discloses a robot-held surgical instrument that may comprise one or more optical fibers. The optical fiber may be used to transmit and receive photons and may be configured to both supply excitation light and transmit scattered photons to an analysis unit, such as a spectrophotometer. The optical fiber enables operation in an optical emission spectroscopy mode for detecting certain chemical substances. The analysis unit may be connected to a computer for inputting parameters for calibrating the spectroscopic function of the instrument or for testing diagnostics. The spectrophotometer may be calibrated using a specific standard, such as standard signals from known solutions or chemical composition of tissue.

From the publication EP 2815713 A1, an instrument for electrosurgical action on biological tissue is known. It contains an electrode, as well as a light guide connected to an input window formed by a body of fluid medium. The light guide is connected to a light-analyzing device for receiving light arising on the electrode during high-frequency (HF) surgical intervention, and directing this light into the light-analyzing device.

Light receivers, such as optical fibres, can become contaminated during operation, in particular by liquids, deposits of substances from smoke and steam, and particles. In addition, a specific system consisting of an analysis device with a light receiver and an analysis unit, as well as a tool with a special electrode and a high-frequency generator, may be used for the first time in a certain operation.

For the RF generator (the energy source for producing the RF spark discharge), the standard deviation of the RF output power is, for example, ±20%. The specific electrical resistance of biological tissue varies greatly: for adipose tissue it is 3.3×10 ⁷ Ohm mm ² /m, for muscle tissue - 2.0×10 ⁶ Ohm-mm ² /m, while for blood it is only 1.6×10 ⁶ Ohm-mm ² /m. Carrying out interventions in different cutting or coagulation modes, for example, when regulating spark discharges, affects the light emission from the RF spark discharge on biological tissue. Thus, the specific light emission also depends on the settings of the RF generator and the instrument and additionally on the shape of the electrode.

The implementation of the optical path of the high-frequency optical emission spectroscopy system from the light source to the analysis unit is a significant factor influencing the quality of the light signal. Optical interfaces in plug-in connectors located outside and inside the analyzing device can significantly worsen the transmission. Contamination of the optical fiber, which occurred, for example, during its manufacture, can worsen the transmission of light or even completely prevent it. A noticeable deterioration in transmission can be caused by defective mechanical fixation of the optical fibers. Errors in connecting the analyzing device to the surgical instrument and / or in their orientation relative to each other can lead to the inability of the analyzing device to obtain a useful light signal. In clinical applications of the high-frequency optical emission spectroscopy (HF-OES) system, the quality of the light signal from the high-frequency spark discharge can also change significantly, for example, due to contamination of the optical fiber with blood, which can distort the results of tissue differentiation or make such differentiation impossible.

In the case of optical emission spectroscopy using high-frequency spark discharges for tissue differentiation, the energy input can cause a large scatter of light intensities, in particular differences in the strength of the high-frequency spark discharges. The high temperature at the beginning of the spark discharge leads to an increase in pressure, which in turn causes an explosive increase in the cross-section of the discharge channel. Because of this, the peak temperature drops. The temperature and pressure around the plasma during excitation of spark discharges are not constant. The plasma impedance between the electrode and the tissue varies. In order for the spectra of high-frequency optical emission spectroscopy to be comparable with each other, each of these spectra must satisfy a quality criterion in order to sort the tissue spectra into assessable and unassessable. What is obtained is not absolute values of signal quality, but only the ratios of individual spectral lines to each other. High-frequency spark discharges occur not only between the tip (point) of the electrode and the tissue; due to contamination, spark discharges can also occur to the side, outside the input window of the optical fiber, as a result of which, for example, a smaller portion of the light radiation is introduced into the glass fiber than without contamination.

Due to the large number of possibilities for combining the electrode, light guide, analysis unit, RF generator, tuning parameters, etc., the test or calibration results of individual system components can be informative only to a limited extent.

The objective of the present invention is to provide an improved solution for operating a system with an analyzing device designed to analyze light effects caused by the operation of a high-frequency surgical instrument.

This problem is solved in a testing device for calibrating an analyzing device intended for analyzing light effects caused by the operation of a high-frequency surgical instrument (hereinafter referred to simply as the instrument for brevity). The testing device proposed in the invention comprises a testing fixture configured to create a plasma test light effect, the light from which is received by a light receiver, wherein the testing device is configured to determine the calibration of the analyzing device based on the determined features of the light from the test light effect for calibrating at least some parts of the analyzing device or the entire analyzing device. The analyzing device may comprise a light receiver, in particular an optical fiber, and an analysis unit, wherein the light receiver is connected to the analysis unit. The analyzing device serves, in particular, to differentiate between types of tissue (tissue differentiation), for example to differentiate between healthy and malignant tissue.

The technical result achieved by implementing the invention consists in ensuring the accuracy of determining the type of tissue under changing conditions of impact on the tissue due to the possibility of easy-to-implement calibration of the analyzing device both before the intervention and during its implementation.

The test fixture of the test device has a test surface that is foreign to the organism (the organism of a human, animal or other living being, in particular the organism of a patient who is to be treated with the instrument), so that the test method carried out by means of the test device is not carried out on a living organism of a human or animal.

The test device preferably consists of a non-biological material. In particular, the test device preferably does not contain human or animal tissue, and human or animal tissue is preferably not used as a test device or part of a test device. This, of course, does not exclude the possibility that the test device may become contaminated with tissue residues or other similar substances during the test during the operation.

The plasma test light effect (also referred to simply as the test light effect for short) generated by the test device is understood to be, for example, a spark discharge or a stationary plasma. Such a light effect may include electromagnetic waves in the infrared, visible and/or ultraviolet parts of the electromagnetic spectrum. The test device may be designed in such a way as to ensure the possibility of receiving and analyzing the infrared, visible and/or ultraviolet components of the spectrum of the test light effect. The light receiver receiving the test plasma light effect may be a test light receiver that is connected to the analysis unit of the analyzing device or may be connected to it during the test. In a preferred embodiment, the light receiver is a light receiver of the analyzing device. The point is that it is preferable to test the analyzing device by means of a testing device in combination with an instrument, and particularly preferably with a high-frequency surgical apparatus for supplying the instrument with high-frequency energy, which are also used in a specific operation, in preparation for which or during which the analyzing device is subjected to testing, for example calibration.

The test device according to the invention preferably enables a member of the operating team with medical training, such as an operating assistant or a surgeon, to verify - before or during an operation - the fundamental functionality of the analyzing device, for which purpose the respective user creates a test light effect by means of a test device, the light from which is received by a light receiver. The test device is preferably designed in such a way as to report to the operating personnel the result of the functionality test (functional test), such as "test passed", i.e. the analyzing device is functional, and/or "test failed", i.e. the analyzing device is not functional, by issuing a corresponding signal or by the absence of a signal, in particular an optical, acoustic or tactilely perceptible signal. Such a test makes it possible, for example, to detect cases in which the optical fiber of the analyzing device is contaminated or defective or in which the analyzing device is incorrectly assembled.

Other suitable features and examples of the implementation of the test device and the system proposed in the invention, as well as the implementation of the method proposed in the invention, are discussed in the following description:

The test fixture may have a test surface for creating a test light effect between an electrode, preferably a tool electrode, and the test surface.

The test surface may be formed by a counter electrode operatively connected to the above-mentioned electrode. The test surface may be electrically connected to a high-frequency surgical apparatus and/or a neutral electrode if it is a monopolar instrument.

The testing device is preferably intended for clinical use. The testing device is preferably designed for its use in the intraoperative phase of an operation performed with a surgical instrument. It is particularly advantageous for the testing device to be arranged and/or to be arranged in a sterile operating area. This particularly simplifies the testing, in particular the calibration, of the analyzing device by means of the testing device immediately before or during the operation.

The testing device preferably comprises an evaluation unit designed in such a way that, based on the characteristics (one characteristic or several characteristics) of the light received when creating the test light effect by means of the testing device, it is possible to evaluate whether the analyzing device is operational. The evaluation unit may be, for example, a part of the analyzing device.

The light features used to assess whether the analyzing device is operational may be, for example: spectrally unresolved light power, i.e. the power integrated over all wavelengths of the received light, the light power at one wavelength or several wavelengths distinguishable from one another (spaced at an interval exceeding the wavelength resolution of the testing device), intensities of individual spectral lines, intensities of groups of spectral lines, the time characteristic of the test light effect, the polarization of the light from the test light effect, typical spectra, fragments of spectra obtained from signature spectra, and/or signatures obtained from the spectrum of light from the test light effect, fragments of the spectrum, and/or spectral lines. Signatures may be obtained in the form of computational values obtained by defined algorithms, formulas, lookup tables, or other processing rules. In particular, signatures may be ratios of intensities of selected spectral lines, ratios, sums and/or differences of various terms, where these terms, in turn, are sums, differences, products, integrals over partial spectra and/or other terms of intensities of various spectral lines or partial spectra or light features or signatures derived from them.

The evaluation criterion may be, for example, the signal-to-noise ratio or the signal-to-background ratio at one wavelength, in groups of wavelengths, in sections of the spectrum, in the entire spectrum, the intensity ratio at different wavelengths and/or groups of wavelengths and/or in sections of the spectrum. In a simple case, it is possible, for example, to determine by means of the test device the light intensity from the test light effect by comparing it with the threshold value whether sufficient light is supplied to the light receiver, which allows a conclusion to be drawn about the operability of the analyzing device.

Alternatively or additionally, the signature can be calculated, for example, on the basis of the intensity ratios of selected spectral lines of light from the test light effect and/or when calculating the signature, the uncertainty can be found on the basis of, for example, noise or background. For example, each signature can be calculated on the basis of the intensity ratios of selected spectral lines characterizing the parts of the material of the test surface and/or the electrode and/or the atmosphere between the electrode and the test surface that have passed into the plasma state. If the uncertainty, for example the ratio of the signature to the uncertainty, exceeds a threshold value, then, for example, the test result of the analyzing device can be considered positive, whereby the evaluation unit generates a corresponding evaluation signal. In the event of a negative test outcome, the evaluation unit can generate a correspondingly different evaluation signal or not generate an evaluation signal at all, or - as an alternative - the output of an evaluation signal may not occur in the event of a positive test result. On the basis of this evaluation signal or another evaluation signal, a signal, in particular an acoustically, optically or tactilely perceptible signal, can be output to the user of the surgical instrument and/or the analyzing device, and/or the evaluation signal can be used to control the testing system of the analyzing device, the analyzing device, the high-frequency surgical instrument and/or the high-frequency surgical apparatus. On the basis of the evaluation signal, values or value ranges of the parameters of the testing device, the analyzing device, the high-frequency surgical instrument and/or the high-frequency surgical apparatus can be set, for example set automatically by the system. This means that the high-frequency surgical system, comprising the high-frequency surgical apparatus, the high-frequency surgical instrument, the testing device, the analyzing device and/or possibly other devices, can be automatically adjusted on the basis of the results of the test carried out by the testing device (with or without the permission of automatic adjustment by the user), due to the fact that on the basis of the test result at least one setting of at least one device of the high-frequency surgical system is selected or changed. Alternatively or additionally, the testing device may, based on the test result, provide a user with a recommendation for at least one setting of at least one device of the high-frequency surgical system, after which the user may decide to adjust the high-frequency surgical system according to this recommendation.

Based on the evaluation signal, the signal output of the analyzing device can be, for example, blocked, and/or, for example, a message can be generated and displayed to the user regarding the accuracy of the analysis of the analyzing device. Thus, the result of the evaluation can be, for example, whether the analyzing device works at all, whether it works with sufficient accuracy, and/or with what accuracy the analyzing device is capable of working.

The testing device is preferably designed in such a way that the sensitivity of the analyzing device at least at one wavelength, in a group of wavelengths, in a partial spectrum or in the entire spectrum and/or the transmittance of the analyzing device at least at one wavelength, in a group of wavelengths, in a partial spectrum or in the entire spectrum are determined and preferably evaluated by means of the test light effect. The sensitivity is the ratio of the magnitude of the electrical signal generated in the analyzing device upon reception of light from the test light effect to the intensity of this light. The transmittance is the ratio of the intensity at the output of the light receiver (e.g. an optical fiber) to the intensity at the input of the light receiver. The transmittance can be affected, for example, by contamination of the input, damage, for example a break between the input and output of the light receiver (where the light signal is converted into an electrical signal) inclusively and/or, for example, on the connecting elements between the input and output of the light receiver. Reference values of sensitivity and/or transmittance, with which the sensitivity and/or transmittance found by the testing device can be compared, can be stored in a database. Since the object of study in determining the transmittance is the light detector of the analyzing device, the analysis unit of the analyzing device can be used in determining the transmittance, or another analysis unit can be connected to the light detector during the test.

The test device preferably contains at least one substance or at least two different substances selected on the basis of emission spectra. This allows obtaining an analysis result with high information content when such substances can create, for example, light features, such as chemical particles, presumably present in the tissue being exposed (treated), and/or when it is possible to determine the accuracy with which the features of the test light effect created by these substances and/or the signatures obtained on their basis can be determined, and this accuracy can be used to judge the accuracy of determining the features and/or signatures of the accompanying light effect and/or the chemical particles participating in the creation of this light effect.

The test device may have a predetermined material composition. The test device, in particular the composition and/or shape of its test surface, is preferably selected based on the clinical indication for the surgical intervention, such as the (suspected) disease, the (suspected) tumor and/or the tissue to be treated.

The test device specifically includes substances that are also found and/or are presumed to be contained in the tissue being examined or exposed to the effect, in order to create a test light effect with the same detectable characteristics as those determined for the light effect created by the action of an instrument on tissue during high-frequency surgical intervention (the light effect that occurs during the intervention).

The electrode, which is placed by the user near the counter electrode to create the test light effect, is preferably specifically selected to create the test light effect based on its composition. For example, this electrode can be selected based on the expected contribution of the substance or material contained therein to the test light effect and/or to the light effect and/or based on one or more features of the light from the test light effect and/or the light effect caused by the composition of the electrode. The electrode can be selected with respect to the expected contributions to the test light effect and/or the light effect based on the composition of the electrode, depending on the clinical indication for the surgical intervention.

The test device may have at least two different test surfaces. The test surfaces may differ in their shape, material composition, state of aggregation (solid, liquid), etc. The compositions of the materials of the test surfaces may differ, in particular, in the type of chemical particles and/or their absolute and/or relative quantities. This makes it possible to determine and/or calculate, based on the result of the analysis of the test light effect and/or the light effect arising from the intervention, the influence exerted by the electrode and/or the electrode material. The test surfaces may differ in that they consist of different materials. For example, the test surfaces may contain different metals, in particular pure metals or alloys, different solutions, in the same or different materials, for example in a sponge or in a felt material. The test may provide for the sequential creation of the test light effect on at least two different test surfaces.

The testing device is preferably designed in such a way as to provide the possibility of calibrating the analyzing device based on the determined light characteristics from the test light effect. For example, to determine the calibration of the analyzing device, the determined light characteristics can be compared with the light characteristics stored in a database. Based on the calibration, at least one parameter of the testing device, the analyzing device, in particular the light detector and/or the analysis unit, the high-frequency surgical instrument and/or the high-frequency surgical apparatus, or another device or component of the system is preferably selected and/or changed. The system is preferably designed in such a way that based on the calibration, at least one parameter of the testing device, the analyzing device, in particular the light detector and/or the analysis unit, the high-frequency surgical instrument and/or the high-frequency surgical apparatus, or another device or component of the system is selected or changed.

Based on the test carried out with the aid of the test device and by means of the test light effect, at least one value or a range of values of at least one parameter, for example a control and/or evaluation parameter, of the test device, the test fixture, the analyzing device and/or the high-frequency surgical device, in particular the high-frequency surgical instrument and/or the high-frequency surgical apparatus for powering the high-frequency surgical instrument, is preferably set by means of the test device. In particular, based on the test carried out with the aid of the test device and by means of the test light effect, a value or a range of values of a parameter of at least one of the above-mentioned devices of the system can be set, which has an effect on the operation of the system consisting of the above-mentioned devices when acting on the tissue. Naturally, in this case it is preferably a value or a range of values of the parameter that ensures the required result of the high-frequency surgical action (treatment), but also leads to an improvement in the analysis of the light effect that occurs during the corresponding intervention, by means of the analyzing device.

The test device is preferably designed with the possibility of setting a minimum distance between the electrode placed by the user of the test device near the counter electrode to create the test light effect, and the test surface of the test device between which and the above-mentioned electrode the test light effect must be created.

The test device is preferably designed with the possibility of specifying the atmosphere, in particular its composition and/or pressure, between the electrode and the test surface and/or the counter electrode. For example, an argon atmosphere can be created between the electrode and the test device.

The test fixture is preferably designed with the possibility of specifying the orientation of the electrode placed near the counter electrode to create the test light effect, and/or the light receiver relative to the test surface. For example, this can be implemented by designing the test fixture in such a way as to direct the movement of the tool and/or the light receiver into the test fixture, ensuring that the tool and/or the light receiver automatically occupy their position, in which the tool and/or the light receiver have a specified orientation relative to the counter electrode.

The test device preferably provides protection of the light receiver from ambient light when receiving light from the test light effect.

The above-mentioned measures - each separately or taken in any (sub-)combination - serve to create such conditions for conducting a test under which the obtained test result is particularly informative.

The testing device is preferably intended for an instrument and an analyzing device combined by a user of the instrument, such as a surgeon, an operating assistant or another member of the operating team, in preparation for or during an operation performed by the instrument. The instrument and the light receiver of the analyzing device are preferably attached to each other by the user of the instrument before and/or during the operation to fix the position of the light receiver of the analyzing device relative to the instrument. It is in such an operating system consisting of an instrument and an analyzing device attached to each other by the user of the instrument that improper handling, damage, contamination, incompatibility of the instrument and the analyzing device can lead to the inoperability of the analyzing device and/or to the need for a special adjustment of the high-frequency surgical device and/or the analyzing device to ensure the possibility of operation of the latter. Such cases can be identified and corrected based on the results of the test performed using the testing device.

Accordingly, the subject of the invention is also a system for high-frequency surgical action on biological tissue, comprising a high-frequency surgical apparatus, a high-frequency surgical instrument connected thereto, a testing device proposed in the invention, an analyzing device for analyzing the light effects caused by the operation of the high-frequency surgical instrument and received by a light receiver, and a mounting device intended for fastening the light receiver to the high-frequency surgical instrument or to a component thereof by the user of the high-frequency surgical instrument or his assistant. Such a mounting device preferably provides the possibility of connecting the light receiver to the instrument by the user of the surgical instrument or his assistant, especially preferably with the possibility of connecting them during an operation.

The mounting device may be, for example, an adapter in which or on which an optical fiber is fixed or can be fixed as a light receiver. The mounting device (hereinafter also referred to as an adapter) can be connected to a tool, for example a tool handle, to fix the position of the light receiver relative to the tool electrode. By means of a test device it can be checked whether the light receiver, thus combined with the tool, is capable of functioning correctly.

The invention also provides a method for calibrating an analyzing device intended for analyzing light effects created by the action of a high-frequency surgical instrument on biological tissue. The method proposed in the invention is characterized in that a test light effect is created between a test device that does not relate to a human or animal organism and an electrode, the light from which is received by a light receiver, and the calibration of the analyzing device is determined based on the determined features of the test light effect. Thus, the method proposed in the invention, in particular, is not carried out on a human or animal organism. The method can be carried out using the test device and/or system described in the present description, comprising a test device and a high-frequency surgical device. In particular, one or more steps of the method can be carried out by the test device and/or system described in the present description or by means of them. The user of the analyzing device, in particular in order to verify the functionality of the analyzing device or to adjust it, may carry out a test by creating a test light effect by means of a test device intended for this purpose, instead of taking a sample from the body for this purpose or even carrying out a test on a patient.

The method can be implemented for preparing an operation immediately before or during an operation, namely by the user of the instrument, for example a surgeon or an operating assistant. The testing device, in particular the testing fixture, is preferably designed for its use for preparing an operation and/or during an operation by a physician who is going to perform a designated (planned) operation with a high-frequency surgical instrument, or by a physician's assistant.

In one embodiment of the method, at least one test light effect can be created in each case between the electrode and at least two different test surfaces with a corresponding analysis of this light effect.

For the test, it is preferable to use a system containing a high-frequency surgical instrument, a high-frequency surgical apparatus and an analyzing device, and also used to perform an operation.

The same tool or test process settings that are to be used to perform the tool operation and/or settings derived from them are preferably used for testing.

Other preferred features of the invention and embodiments thereof are given in the dependent claims of the invention, as well as in the following description, illustrated by drawings, which show schematically and as an example:

Fig. 1a - illustration of the location of the light receiver relative to the electrode or the light effect created when the electrode acts on the tissue,

Fig. 1b is a schematic representation of the tip of an electrode in the cone of light reception by an optical fiber,

Fig. 2a - an example of the implementation of the instrument in the form of a handle with a distally located electrode inserted into an adapter having a light receiver made in the form of an optical fiber,

Fig. 2b - a fragment of a combination of a tool and an adapter, such as shown

in Fig. 2a, with a different electrode shape,

Fig. 3 shows an example of the implementation of a system containing a high-frequency surgical device, an analyzing device and a testing device,

Fig. 4 is another example of the implementation of a system containing a high-frequency surgical device, an analyzing device, and a testing device,

Fig. 5 shows an example of the test fixture,

Fig. 6a shows another example of the test fixture,

in Fig. 6b1 and 6b2 - examples of the implementation of the counter-electrode and electrode,

Fig. 6b - an example of the implementation of the counter electrode and

Fig. 7 shows an example of implementing the method proposed in the invention.

Fig. 1a shows an example of using an electrode 10 in a surgical instrument 11. The electrode 10 is located near the tissue 12 of the patient's body to be affected. The means for holding the electrode 10, such as, for example, a handle, are not shown in Fig. 1a for clarity. The electrode 10 has a rod 10a, as well as a head or tip 10b, which can consist, for example, of titanium or tungsten. Insulation 10c is applied to the electrode 10 near the head or tip 10b for more accurately isolating those sections of the electrode 10 between which and the tissue 12 a plasma 13, in particular spark or arc discharges, is generated. The electrode 10 used when the light effect 13 occurs, accompanying such a plasma intervention, is preferably a partially insulated cutting electrode, such as, for example, used in high-frequency (HF) surgery. Electrode 10 preferably has heat resistance to spark discharges at least with respect to titanium or tungsten.

An optical fiber 14 located in a hose 15 or tube 15 is arranged at an acute angle W to the electrode 10. The relative position of the optical fiber 14 and the hose 15, on the one hand, and the electrode 10, on the other hand, is fixed. The drawing shows a light-receiving cone 16, covering all directions from which the optical fiber 14 can receive light and direct it to the analysis unit (not shown in Figs. 1a and 2) for analyzing the light. As shown, the tip or head 10b of the electrode 10 is located within the light-receiving cone 16. This is also visible in the schematic section of the light-receiving cone 16 shown in Fig. 1b. In this way, the light effects 13 arising between the electrode 10 and the tissue 12, for example the stationary plasma characteristic of argon plasma coagulation, the electric arc discharge, or the spark discharges which can be formed and occur in rapid succession, are within the limits of the light receiving cone 16. Thus, the light emanating from them, containing infrared, visible and/or ultraviolet waves, partially enters the optical fiber 14 and is directed to the analysis unit.

The hose 15 serves to direct a fluid medium, in particular a gas, such as _CO2 , to the distal end of the hose 15, where this medium exits in the direction of the electrode 10. The flow of fluid serves to reduce contamination of the optical fiber 14, clean the optical fiber 14 and blow away steam or particles formed during electrosurgical action on tissue 12.

However, despite the blowing out of the _CO2 flow, the flow rate of which is preferably limited to a maximum of 1 liter per minute in order to avoid displacing the tissue 12 being affected, particles or vapors can settle at the input 17 of the optical fiber 14, which limit the transmittance of the optical fiber 14. Such a limitation of the transmittance can also be observed only for certain wavelengths, for example in the infrared, visible and/or ultraviolet region of the electromagnetic spectrum. Contamination of the electrode 10 can lead to a partial shading of the input 17 of the optical fiber 14. Due to contamination of the electrode 10, the shape of the light effect 13 can be partially changed, since such contamination can electrically isolate part of the tip or head 10b. Contamination can occur not only due to vapors or flying particles. It is also possible that the surgeon accidentally allows the electrode 10 to touch the tissue 12. The point is that the discharge distance (discharge gap) between the electrode 10 and the tissue 12, the excess of which will not allow the light effect to be ignited, may be, for example, only a few millimeters between the distal end of the electrode 10 and the tissue 12, if the light effect is ignited in a medium enriched with a noble gas, such as argon, or even a few tenths of a millimeter, if the light effect is ignited in a medium enriched with CO ₂ . Contamination may also lead to a change in the spectrum of light effects.

The amount of light from the light effect 13 captured by the optical fiber 14 depends greatly on the position of the optical fiber relative to the electrode 10. For example, it depends on the distance A from the input 17 of the optical fiber to the tip of the electrode 10 and/or the light effect 13, on the location of this input 17 around the electrode 10, on the angle W between the optical fiber and the electrode 10, and other factors.

Fig. 2a shows a high-frequency surgical instrument 11 in the form of a high-frequency applicator with a handle 11a and an electrode 10, preferably a replaceable electrode. The applicator 11 is inserted into an adapter 19. Alternatively, the applicator 11 and the adapter 19 can, for example, be located next to each other with the possibility of attaching them to each other.

The adapter 19 contains the optical fiber 14 fixed in it or on it and can form a channel 20 for releasing the CO ₂ flow. The adapter 19 serves to attach the optical fiber 14 and the instrument 11 to each other. A surgeon or other member of the operating team can connect the adapter 19 to the instrument 11, for example during an operation.

The adapter 19 ensures that the position of the optical fiber 14 is fixed relative to the electrode 10. There are many possibilities for varying the design. For example, the electrode 10 is preferably replaceable. Various shapes of the tip or head 10b of the electrode 10 are possible. For example, needle-shaped and spatula-shaped electrodes 10 are known. Fig. 2b shows, as an example, the use of a hook-shaped electrode 10 instead of the electrode 10 shown in Fig. 2a. In addition, the electrodes 10 can have different lengths and, thus, can protrude from the adapter 19 at different distances. However, the position, i.e. the distance and/or orientation, of the entrance 17 of the optical fiber relative to the electrode 10, and hence the position of the light effect 13 relative to the light receiving cone 16, depends on the shape and length of the section of the electrode 10 protruding from the adapter 19.

Fixing the position of the optical fiber 14 relative to the electrode 10 is particularly reliable when the high-frequency applicator 11 fits the adapter 19. However, a situation is possible when a high-frequency applicator 11 is used accidentally or intentionally, to which the adapter 19 does not fit. In this case, ensuring the correct position of the optical fiber 14 relative to the electrode 10 may be impossible.

It is also necessary to mention the possibility of damage to the light receiver, for example the optical fiber 14. In addition, the connecting elements used between the light receiver 14 and the analysis unit or between individual parts of the light receiver 14 in its composite design may also be defective, which impairs the transmission of light.

Electrode 10, or instrument 11, is supplied with electric energy from a high-frequency generator (not shown in Fig. 1a and 2). For high-frequency generators, a standard deviation of the output high-frequency power of ±20% is permitted by law. Depending on the type of high-frequency surgical intervention required, such as dissection, coagulation, devitalization, thermocoagulation, etc., different powers, forms of the high-frequency voltage signal supplied to electrode 10, etc. are required. The properties of the high-frequency voltage supplied to electrode 10 are called a mode. The mode affects the emission of light from a high-frequency light effect 13, such as a high-frequency spark discharge, in biological tissue 12.

In addition, the specific electrical resistance of biological tissue 12 varies greatly. For adipose tissue it is approximately 3.3×10 ^{7 Ohm⋅mm2} /m, for muscle tissue - 2.0×10 ^{6 Ohm⋅mm2} /m, while for blood - only 1.6×10 ^{6 Ohm⋅mm2} /m. In addition, the environment (aerosol, air mixture) between the electrode 10 and the tissue 12 can be highly dependent on the specific application. Depending on whether the intervention is carried out by open surgery, endoscopically or laparoscopically, the humidity between the electrode 10 and the tissue 12, for example, can vary greatly. The possibility of ignition (ionization) of the plasma 13 is greatly influenced by the presence of moisture or liquid at the active electrode 10. The atmosphere between the electrode 10 and the tissue 12 can be partially determined by the high-frequency surgical device, depending on, for example, whether argon gas or CO ₂ is released into the region between the electrode 10 and the tissue. The discharge voltage (breakdown voltage) depends on the type of gas. In an argon atmosphere, for example, the spark discharge 13 is ignited differently than in dry air or a CO _{2 atmosphere.}

In summary, it can be stated that the type of light effect 13 or its features, in particular its shape, intensity, spectral composition, etc., are very much dependent on the individual conditions of a specific surgical intervention and can change during the course of the intervention. The share, including that dependent on the wavelength, of the light created by the light effect 13, captured by the optical fiber 14 and/or converted into an electrical signal in the analyzing device also greatly depends on the conditions of the operation.

An improved solution of the system S in accordance with the invention for high-frequency surgical action on tissue 12 (in particular tissue dissection and/or coagulation) using optical emission spectroscopy is shown schematically in Fig. 3 as an example. The system S (high-frequency surgical system) comprises a high-frequency surgical device E, which includes a high-frequency surgical instrument 11, in this case made in the form of an applicator 11 with a handle 11a and an electrode 10 fixed to the distal end of the handle 11a, and a high-frequency generator 21 for powering the instrument 11. The high-frequency surgical device E is a device for monopolar high-frequency surgery, in which the electrical circuit is closed by means of a neutral electrode 22 fixed to the patient. As an alternative or in addition, the high-frequency surgical device E is designed to perform interventions using the bipolar high-frequency surgery method.

The system S also comprises an analyzing device AE for analyzing light effects, in particular stationary plasma, arc discharges, spark discharges, occurring between the electrode 10 and the tissue 12 of the patient's body, by means of optical emission spectroscopy in the infrared, visible and/or ultraviolet region of the spectrum. The analyzing device AE comprises an optical fiber 14, used as a light receiver, and an analyzing unit 23, connected to the optical fiber 14. The optical fiber 14 can be fixed on the instrument 11 by means of an adapter 19, as shown in Fig. 1a. The light signal transmitted by means of the optical fiber 14 from the place where the intervention is carried out is converted by the system S into an electrical signal.

The testing device TE for testing, in particular for calibration, the analyzing device AE comprises a testing fixture 24, which forms a counter electrode 25 with a testing surface 26. By means of the tool 11, it is possible to create a test plasma light effect, generated between the tool 11 and the testing fixture 24, for example in the form of a spark discharge or a continuously maintained plasma. The testing fixture 24 is thus designed with the possibility of creating a test plasma light effect. The counter electrode 25 can have the same electrical potential as the neutral electrode 22. The counter electrode 25 can be, for example, connected to the HF generator 21 via the neutral electrode 22. The testing device TE also comprises an evaluation unit 27. This evaluation unit 27 can be combined with the analysis unit 23 in a single apparatus or can be part of the analysis unit 23. The analysis unit 23 and/or the evaluation unit 27 can be built into different devices. The analysis unit 23 and/or the evaluation unit 27 can also be distributed over several devices and can be formed, for example, by one or several software modules executed in one device or in several devices. The testing device TE can also contain a signaling device 28 for optical, acoustic and/or tactile output of a message to the user of the system S. The signaling device 28 is connected to the evaluation unit 27 for initiating the output of messages received from it.

The broken line L indicates the boundary separating the sterile zone 29 of the operating room from the non-sterile zone. As shown, the test device TE is partially located in the sterile zone 29. In particular, the test device 24 is located within the sterile zone 29.

By means of the test device TE shown in Fig. 3 it is possible to check whether the system S, in particular the analyzing device AE, is functional and/or whether the system S, in particular the analyzing device AE, can be adjusted so that it is possible to work with the system S or the analyzing device AE. In particular, the test device preferably makes it possible to check whether it is possible to carry out a differentiation of tissues by means of the analyzing device AE by means of the optical emission spectroscopy method based on the light effects caused by the action of the electrode 10 on the tissue 12. Alternatively, the test device TE makes it possible to find by means of a test a setting of the system S, in particular the analyzing device AE, which ensures the possibility of its/his operation with a specified accuracy.

Fig. 4 illustrates a system S for high-frequency surgery using optical emission spectroscopy. The embodiment of the invention shown in Fig. 4 can be considered as a specification of the system S shown in Fig. 3 or as another embodiment of the system S proposed in the invention. In Fig. 4, flows of media, energies and signals (high-frequency current H, light Li, state signal Sg and purge medium M, for example CO ₂ ) are designated. High-frequency electrode 10 is supplied with high-frequency electrical energy along line 31 passing in the handle, which is connected by line 32 to high-frequency surgical apparatus 21. High-frequency current flows between high-frequency electrode 10 and body 12 of the patient. In this case, a light effect 13 is created, the light from which is received by optical fiber 14 and directed to the analysis unit 23. By means of the blow-out system 33, a blow-out medium, in particular _CO2 , is released into the site of the intervention between the electrode 10 and the tissue. The blow-out system 33 is controlled by means of the foot switch 34. The high-frequency surgical device E is controlled by means of the keys 35 (see Fig. 2a) on the handle 11a and/or on the surgical apparatus 21.

When testing is carried out by means of the testing device TE, a current flows between the electrode 10 and the testing surface 26. In order to create a certain atmosphere between the electrode 10 and the testing surface 26, a purge medium can be released. The light from the spark discharge is received by the light receiver 14 and directed to the analysis unit 23. The analysis unit 23 can output a status signal to the high-frequency applicator 11 or the adapter 19.

As shown in Fig. 4, the testing device TE may have several testing surfaces 26. The testing surfaces 26 may differ from each other. The testing surfaces 26 may differ, in particular, in the composition of their material, shape, size, phase or aggregate state of the testing surface 26 (e.g. liquid, solid), etc. Each testing surface 26 may contain an alloy or a pure metal (with a purity greater than or equal to 95%). The alloys of the different testing surfaces 26 and/or the pure metals contained in the different testing surfaces 26 may differ from each other.

Fig. 5 shows a sectional view of an example of the embodiment of the test device 24. The test device 24 can be used, for example, in the system shown in Fig. 3 or 4. The test device 24 comprises a distance element 36 and a holder 37 of the test surface 26. The test surface 26 is formed by a reference electrode or counter electrode 25. The counter electrode 25 can be, for example, a metal plate or foil.

The distance element 36 has an opening 38 into which the adapter or tool 11 can be inserted or on which or at which the adapter or tool 11 can be mounted. The function of the distance element is to ensure that the distance between the tool 11, the handle and/or the adapter, on the one hand, and the test surface 26, on the other hand, does not exceed its maximum permissible value.

The opening 38 is preferably designed with the possibility of guiding the movement of the tool 11, the adapter 19 and/or the electrode 10 and/or the light receiver 14 for fixing a certain position of the electrode 10 and/or the light receiver 14 relative to the counter electrode 25. The shape of the opening 38, on the one hand, and the shape of the tool 11, the electrode 10, the light receiver 14 and/or the adapter 19, on the one hand, are preferably matched to each other in such a way that when these shapes are mated, fixation of the position of the tool 11, the light receiver 14, the electrode 10 and/or the adapter 19 relative to the test surface 26 is ensured.

Between the opening 38 in the spacer 36 and the test surface 26, a cavity 39 for plasma (plasma cavity) is formed. The cavity 39 is formed by electrically insulating walls 40 (not counting the counter electrode 25). The test device 24 has at least one outlet opening 41, through which gas coming from the adapter into the cavity 39 can exit, which makes it possible to maintain a certain pressure of the protective gas Sc, for example CO ₂ or argon, in the cavity 39, or to prevent exceeding a certain pressure. For example, argon can be supplied to the line 15 passing in the adapter 19 for carrying out the test. In addition, the outlet opening 41 ensures the constancy of the above-mentioned atmosphere due to the continuous renewal of the medium in the cavity 39. As can be seen in Fig. 5, the electrode 10, which together with the light receiver 14 is part of the high-frequency instrument 11, projects beyond the distal end of the instrument 11 or adapter 19 and enters the cavity 39 for plasma. The input 17 of the optical fiber 14 is located with a shift in depth relative to the output 42 (see Fig. 2a) of the adapter 19 or instrument 11.

The counter electrode 25 can be connected via an additional resistor 43 to the high-frequency generator 21. The electrode 10 is also connected to the high-frequency generator 21 to receive high-frequency energy from it. Thus, a light effect (test light effect) 44 is created between the tip 10b of the electrode 10 and the counter electrode 25.

The material for the counter electrode 25 or the test surface 26 can be specifically selected based on the clinical indication for the high-frequency surgical intervention. For example, this material can contain chemical particles that are also presumably contained in the tissue 12 that is subjected to action during the high-frequency surgical intervention, in particular to dissection and/or coagulation.

Fig. 6a shows an alternative embodiment of the test device 24. The test device 24 can be used, for example, in the system shown in Fig. 3 or 4. The test surface 26 in the embodiment under consideration is formed by a sponge or non-woven material 25 impregnated with a reference solution, in particular a saline solution. This makes it possible to create a test surface 26 that is close to the surface of the real tissue 12. Substances that need to be confirmed and/or isolated during testing using the testing device TE can be deliberately included in the solution. The solution and/or such substances introduced into it can be deliberately selected on the basis of a clinical indication for high-frequency surgical intervention. This makes it possible, for example, to differentiate chemical particles, and thus also to differentiate "tissues", when testing is carried out not on the patient's body, but on a material different from it. The reference solution can be specifically selected based on the medical indication for the surgical intervention, since a certain reference solution contains chemical particles, the presence of which, individually or in a specific composition, is also expected in the tissue 12, which is partially converted into a plasma state during high-frequency surgical intervention and therefore introduces certain light characteristics into the light effect 13 that occurs during this intervention.

As provided in the examples shown in Fig. 5 and Fig. 6a, the test surface 26 can be substantially flat. As an alternative to these examples, the counter electrode 25 can have a tip or point 45, as provided in the examples shown in Fig. 6b1 and 6b2. The electrode 10 can have, for example, a round spatula-shaped form, i.e. a spatula shape (Fig. 5), a point shape, or a pointed shape (Fig. 6a, Fig. 6b1) or a spatula-shaped shape with sharp corners (Fig. 6b2). The electrode 10 can have insulation that leaves the tip or head of the electrode 10 uninsulated. In Fig. 6c shows an example of the implementation of the counter electrode 25 in the form of a metal plate with grooves 46. By means of the shape of the electrode and the shape of the counter electrode, it is possible to preset the shape of the test light effect 44, which makes it possible to obtain an informative test result.

The counter electrode 25 is preferably heat-resistant if it is intended for repeated use. However, it is preferable that its heat resistance is lower than the heat resistance of the electrode 10. The test device TE is preferably sterilizable. The test device TE, in particular the test device 24, can be intended for repeated use. If the test device 24 or the counter electrode 25 is a disposable article, the counter electrode 25 is preferably formed by an impregnated sponge or non-woven material.

Using the system S proposed in the invention, in at least one of the described embodiments of the invention, it is possible to work, for example, as follows:

The system S, shown for example in Fig. 3 or 4, can be assembled only by the operating team for carrying out the planned intervention. In particular, the instrument 11 and/or the electrode 10 and/or the test device 24 and/or the test surface 26 or the counter electrode 25 can be selected for the intervention based on a clinical indication. In preparation for the intervention or during the intervention, the user of the analyzing device AE can perform a functional test of the analyzing device AE, for which the user creates a test light effect 44 between the electrode 10 of the instrument 11 and the counter electrode 25 by means of the instrument 11 (step 101 of the method 100 in the example shown in Fig. 7). Possible results of the functional test can be, for example, the conclusions "works" or "does not work". For this purpose, the user can insert the tool 11 into the opening 38 of the test fixture 24 or place it on this opening 38. In this regard, the test device TE can be configured to recognize the assembly of the tool 11 with the test fixture 24 in order to create the test light effect 44. The test device TE can, for example, be configured to recognize the insertion of the tool 11 or the adapter 19 into the opening 38 or to place them on this opening. When recognizing the test intended by the user, the test device TE can advantageously select certain settings of the system S, in particular of the high-frequency surgical device E. For example, in order to carry out the test, the test device TE can block certain settings of the system S that are otherwise accessible, or allow settings that are otherwise inaccessible. Alternatively or additionally, the test device TE can be configured to switch the system S into the test mode by a member of the operating team by means of a control element (not shown in the drawings). The user can initiate the creation of the test light effect 44 himself, or the test can be started automatically by the test device TE. The test device TE can comprise means (not shown) for recognizing the position of the electrode 10, the tool 11 and/or the adapter on the test fixture 24 or in the test fixture 24. This makes it possible, for example, to automatically determine whether the electrode 10, the tool 11 or the adapter is located at a distance from the test surface 26, as a result of which the creation of the test light effect 44 is automatically initiated or the creation of the test light effect is allowed to be started manually. In this regard, the test device TE can be designed with the possibility of automatically selecting a setting suitable for creating the test light effect, based on the conditions of the test (for example, the electrode 10, the tool 11 used, the high-frequency surgical apparatus 21, the type of the counter electrode 25, etc.). The test settings or test setup options are selected so that the high-frequency electrode 10 or the optical fiber 14 are not damaged during the test. For example, it is preferable that the high-frequency voltage between the electrode 10 and the counter electrode 25 can be selected. It depends, in particular, on the shape of the electrodes 10, on the distance between the electrodes 10, on the material of the electrode 10 and the counter electrode 25, and on the gas located around the electrode 10 and the counter electrode 25 in the test device 24. Alternatively or additionally, essentially the same system setting S can be used to create the test light effect 44 as for the actual high-frequency surgical intervention.

When starting the test, a plasma test light effect 44 occurs between the electrode 10 of the tool 11 and the counter electrode 25, for example a stationary plasma, as in the case of argon plasma coagulation, an electric arc discharge or a spark discharge, due to the fact that the high-voltage pulse ionizes the atmosphere between the electrode 10 and the test surface 26 and thereby makes it electrically conductive. Due to this, the corresponding gap becomes low-resistance with the possibility of passing a current of several amperes through it. When exciting spark discharges, for example, the current is interrupted after a few microseconds, resuming its supply after the break. The series of spark discharges depends on the pulse repetition frequency of the generator, which is, for example, 20 kHz. The shape of the current waveform emitted by the voltage source can be a pure sinusoid with a frequency of, for example, 350 kHz or a modulated (sinusoidal) voltage waveform. A single pulse, a pulse packet with several oscillations, each of which has a repetition frequency, can be used, which allows, for example, to maintain the plasma. When creating a test light effect 44 or a light effect 13 arising during an intervention (this is how the light effect caused by the intervention itself, performed on the tissue 12 of the patient by means of the electrode 10, can be called), regulation of voltage, power or plasma parameters can be used. When regulating the plasma parameters (also called regulating the parameters of the electric arc discharge), one or more plasma features, for example certain higher harmonics, are maintained at a constant level or within a certain range.

The light from the test light effect 44 is partially received by the light receiver 14 (step 102) and is directed to the device 23a (see Fig. 4) of the analysis unit 23, which is designed to convert the light transmitted via the optical fiber 14 into an electrical signal, which is directed to the test device TE for further evaluation by the evaluation unit 27. The device 23a can convert the light, for example like a spectrometer, depending on the wavelengths into individual components of one or more electrical signals.

In order to evaluate the operability of the analyzing device AE, it is possible to determine, for example, the signal power from the test light effect 44, which is supplied to the evaluation unit 27. The evaluation unit 27, for example, can compare this power, for example the total signal power or the values of its intensity at specified wavelengths, with reference values in order to check the transmission of light from the test light effect 44 to the device 23a for converting the light signal into an electrical signal. In this case, the energy supplied for creating the test light effect 44 by means of voltage and high-frequency current can be taken into account.

The test is particularly informative if the test fixture 24 ensures the orientation of the electrode 10 relative to the test surface 26 or the counter electrode 25 and/or fixes the position of the electrode 10 relative to the test surface 26 and/or the counter electrode 25. Alternatively or additionally, the test fixture can ensure the orientation of the adapter 19 relative to the test surface 26 or the counter electrode 25 and/or fixes the position of the adapter 19 relative to the test surface 26 and/or the counter electrode 25. If the test light effect turns out to be, for example, too weak, or no discharge ignition has been detected at all, this may indicate an incorrect position of the optical fiber 14 relative to the electrode 10. This is an example of how the test device TE can detect errors in handling the equipment, other errors made when aligning the optical fiber 14 with the tool 11, or unsuitable equipment of the tool 11 for analyzing the light. electrode 10.

If the test device 24 is designed in such a way that during the test the input 17 of the light receiver 14 is protected from extraneous light from the environment, this makes it possible, additionally or as an alternative, to increase the informativeness of the test results. In this way, the ambient light is not mixed with the received light, whereby this means that a certain amount of light from the environment enters the light receiver in any case, which does not affect the performance of the test by means of the test device TE. As an alternative or in addition, the test device TE can be configured to operate with an illuminator of the surgical field (not shown in the drawings). The analysis unit 23 and/or the evaluation unit 27 is preferably insensitive in the spectral range in which the illuminator of the surgical field operates. In this way, it is possible to do without shielding the evaluation unit 27 and/or the analysis unit 23, in particular their discriminator (not shown in the drawings), which serves to correlate the light features with the tissue features in order to ensure the possibility of distinguishing between tissues by means of the analyzing device AE.

For a given generation of plasma, in particular the excitation of spark discharges, it is expedient to use a certain atmosphere in which the excitation is carried out, such as, for example, an atmosphere of high-purity gaseous argon. The presence of several parts per million of oxygen in argon, as well as water vapor or vapors of organic compounds, which are always present in biological tissue 12, can create noticeable interference with the discharge. Therefore, by means of the test device TE, the atmosphere in which the plasma is ignited is preferably determined to create the test light effect 44. This applies in particular to the composition of the atmosphere and/or the pressure in it. In the test device 24, an ignition cavity (plasma cavity) 39 is formed. For example, during the test, the plasma cavity 39 in the test device 24 is filled with a gas, for example CO ₂ and/or argon. A constant pressure can be maintained in the ignition cavity 39. If the spark discharges are generated under protective gas conditions (e.g. argon gas), this allows the influence of other environmental factors (microclimate during instrument operation) to be virtually completely eliminated. The use of a noble gas, e.g. argon, allows the intensity of the light emission signal to be positively enhanced. The test fixture 24 may have, for example, a connection (not shown in the drawings) for feeding the plasma cavity 39 with argon, so that the plasma cavity can be filled with a noble gas, in particular argon, for example to create the test light effect 44, whereas in other cases, in particular during high-frequency surgical intervention, the blowing device operates on CO ₂ .

According to the solution proposed in the invention, it is possible to test a specific analyzing device AE, which is used or is supposed to be used in a surgical intervention. In particular, it is possible to test the operability of a specific light receiver 14 and the analysis unit 23, namely by means of a test plasma light effect 44, created between the electrode 10, which is used in the intervention, and the counter electrode 25 without affecting the patient's body. Thus, the test conditions are very close to the use of the instrument for its direct purpose due to the use of practically identical components, as well as plasma ignited by means of the electrode 10 of the instrument 11 in the same way as in the intervention itself. By means of such a test it is possible to exclude an incorrect position of the optical fiber 14 relative to the electrode 10, for example due to an incorrect fit of the handle in the adapter, the use of an incorrect electrode 10, contamination or damage to the optical fiber 14, insufficient connection between sections of the optical fiber 14 or between the optical fiber 14 and the device 23a for converting the light signal into an electrical signal. It is also possible to exclude shadowing caused by possible contamination of the electrode 10, an unfavorable shape of the test light effect 44 (and therefore possibly also the light effect 13 arising during the intervention) due to contamination or an unfavorable shape of the electrode. With the help of the test device TE it is possible to check whether the intensity of the light signal received in the analysis of the light features from the light effect 13 arising during the high-frequency intervention on the tissue 12 is sufficient for an informative assessment of this light signal and whether the results of this assessment can be used.

For exciting the test light effect 44, a high-frequency surgical apparatus 21 of the high-frequency surgical device E is preferably used, which also supplies the electrode 10 during intervention on the patient's tissue 12. For this purpose, the analyzed probe (test surface 26, counter electrode 25) and the high-frequency electrode are connected to the generator 21.

The TE testing device may optically, acoustically and/or tactilely transmit a status signal (e.g. "analysis device operational" or "analysis device inoperative") to the user working in the surgery via a signaling device.

The testing device TE can be designed with the possibility, when necessary, of issuing recommendations to the user for taking measures that would improve the analysis performed by the analyzing device AE, in particular to obtain a stronger signal. For this purpose, the testing device TE can determine, for example, the probability that one or more limitations are responsible for a possible negative test result.

By means of the testing method 100, within the framework of calibration, it is possible to determine the dependence of the transmittance of the light detector 14 on the wavelength and, if necessary, to find one or more corrections (correction factors) that could be taken into account when evaluating the signal from the test light effect 44 and/or the signal from the light effect 13 that occurs during the intervention. The determination of the above-mentioned dependence, the finding of the corresponding corrections and/or their consideration can be automatically performed by the testing device TE and/or the analyzing device AE.

In order to determine the dependence of the transmittance on the wavelength, a test light effect 44 is preferably created, in the spectrum of which there are at least two or more spectral lines, and/or several test light effects 44 are created, in the spectrum of each of which there is at least one spectral line, wherein at least one spectral line of one test light effect 44 differs from the spectral line of another test light effect 44. Such test light effects 44 can be purposefully created if the composition of the test surface 26 is selected according to the type of chemical particles in the composition of its material and, therefore, according to the characteristic spectral lines, and also according to the frequency of these chemical particles.

The creation of plasma for obtaining the test light effect between the electrode 10 and the counter electrode 25 leads to the entrainment (evaporation, atomization and ionization) of the material of the counter electrode 25 and/or the electrode 10, as a result of which the material of the counter electrode 25 and the electrode 10 is left by chemical particles (atoms, molecules, their ions), which pass into the plasma and are detected in it. The supply of energy leads to these chemical particles emitting radiation. Light arises, the spectrum of which has components in the infrared, visible and/or ultraviolet region with spectral lines characteristic in their position and intensity for the corresponding chemical particles.

This is used by the AE tissue differentiation analyzer because when plasma is ignited between the electrode 10 and the tissue 12 during surgical intervention, chemical particles of the tissue 12 material are separated from the tissue and enter the plasma, which thereby make their characteristic contribution to the light spectrum from the light effect 13 that occurs during the intervention. For each new clinical indication, its own microelements are, as a rule, decisive in terms of the possibility of performing tissue differentiation during surgery.

It is therefore preferable to specifically select the composition of the test surface 26 or the counter electrode 25 based on the clinical indication for the intervention, in particular based on the expected composition of the tissue 12 to be treated by the high-frequency surgery method, and/or to specifically select the composition based on the emission spectrum obtained when the material of the counter electrode 25 is converted into the plasma phase. As the material of the counter electrode 25 or the test surface 26, it is possible to select substances, for example one or more metals (in particular pure metal or alloy) or a liquid (reference solution) with chemical particles contained therein (reference substances), which also characteristically occur and/or are presumably contained in the biological tissue 12 to be examined, for example Ca, K, Mg, Na, P, Cl, Cd, Zn, Rb, Cr, Co, Fe, I, Cu, Mn, Mo, Se, F, Si, As, Ni, Sn and V. This makes it possible to create a test light effect 44, for which it is possible to determine light characteristics, also generated during the occurrence of a light effect 13, accompanying an intervention by means of the action of the instrument 11 on the tissue 12. The test device 24 can be specifically selected, for example, by the operating team on the basis of a clinical indication.

The test device 24 can have two different test surfaces 26, which differ in the composition of their material. For example, several metal plates with test surfaces 26 made of different pure metals can be provided. In this way, the influence of the material of the electrode 10 can be calculated, since the material of the electrode can also contribute to the spectrum of the test light effect 44 and/or the light effect 13 that occurs during the intervention.

The electrode 10 for creating the test light effect 44 can also be specifically selected on the basis of its composition, in particular on the basis of the expected light characteristics contributed by the substance of the electrode 10 to the test light effect 44 and/or the light effect 13 that occurs during the intervention. The spectrum of contributions of the material of the electrode 10 to the test light effect 44 and/or its characteristics can be used, for example, as a reference spectrum or reference light characteristics. This is of importance in particular when the electrode 10 is specially selected according to its material in accordance with the clinical indication for the subsequent operation carried out with the aid of the system S. The spectral lines of the material of the electrode 10 are preferably not superimposed on the spectral lines of the tissue 12 to be examined and/or the material of the counter electrode 25, so as not to distort the test and/or spectroscopy results obtained by means of the light from the test light effect 44 or the light effect 13 arising during the intervention. The material of the electrode and the material of the test surface 26 and/or the counter electrode 25 can be different in order to enable the correlation of light features, or signatures, or microelements.

As a supplement or alternative, the performance test of the analyzing device AE, in addition to the test described above for determining the signal intensity, may include determining the accuracy, for example the signal-to-noise ratio, in the entire spectrum of the test light effect 44, in selected areas of this spectrum and/or on one or more specific spectral lines, namely the accuracy with which the signal intensity obtained from the test light effect 44 can be determined at one or more wavelengths. The accuracy is preferably determined for one or more spectral lines present both in the spectrum of the test light effect 44 and in the spectrum of the light effect 13 arising during the intervention. The fact is that a possible method for differentiating tissues, applied by means of the analyzing unit 23, is based on determining, by means of the features of the spectrum of light emanating from the light effect 13 arising during the intervention, a signature, by means of which the features of the tissue that caused this signature are determined. In order to differentiate between healthy tissue 12 and pathological tissue 12, for example, each signature can be calculated on the basis of the intensity ratios of selected spectral lines characterizing the evaporated parts of the biological tissue 12. Based on the established accuracy, it can be determined by means of the testing device TE whether it is possible to differentiate tissues by means of the analyzing device AE.

As a supplement or alternative, when performing the test, it is possible to differentiate one or more substances that are specifically used in the composition of the material of one or more test surfaces 26. The test device TE can be designed, for example, in such a way that, based on the characteristics of the light from the test light effect 44, signatures are determined that are calculated based on the intensities at several wavelengths or in several partial spectra, wherein each signature is preferably calculated based on the intensity ratios of selected spectral lines that characterize the parts of the material of the test surface 26 that have passed into the plasma state, and/or the electrode 10, and/or the atmosphere between the electrode 10 and the test surface 26. The test device TE can have means (not shown in the drawings) for receiving information on the composition of the test surfaces 26 in order to transmit such information to the test device TE. The testing device TE can compare the result of differentiation based on the analysis of light from the test light effect with information that the testing device TE has received using the means for receiving information about the composition of the test surfaces 26.

Based on the test result, the test device TE may provide the user with a signal about the test result and/or identify one or more possible measures aimed at improving the accuracy or improving tissue differentiation, such as by replacing or cleaning one or more selected components of the system S.

When determining the ratio between the intensities of the spectral lines in the light from the test light effect 44 and/or the light effect 13 arising during the intervention, the dependence of the transmittance on the wavelength determined from the test light effect 44 can be taken into account by means of a correction factor.

The system S, in particular the analyzing device AE, can be calibrated by means of the spectrum of the test light effect 44, in order to thereby enable the constant factors influencing the passage of light through the input of the optical fibre 14 to the device by means of which the light is converted into an electrical signal to be taken into account. Excessively large deviations in the light power upwards or downwards are detected by the system S and, for example, compensated for by means of a correction of the integration time or, for example, by means of a correction factor of the analyzing unit 23. In this way, the calibration of the entire system S with all relevant units and blocks that can influence the quality of the spark discharge signal can be taken into account and adjusted. The system S can be calibrated by means of the testing device TE. Calibration means that the accuracy of the system S is determined within the framework of the test and, on the basis of the test carried out by means of the testing device TE, at least one setting or parameter of the system S, in particular the analyzing device AE and/or the high-frequency surgical device E, is preferably found and set, which ensures the achievement of the required operating accuracy of the analyzing device AE.

The test result determined by analyzing the light received when creating the test light effect 44 can be obtained before or during the operation and stored as a reference value (reference value, or benchmark) for the remaining operations. By means of this reference value, in particular the reference signal, it is possible, for example, to identify spectral lines in the light from the intervention-induced light effect 13 between the electrode 10 and the tissue 12.

The test device TE is preferably used in the sterile zone 29, so that the light transmission can also be checked after use during the operation. The advantage for the user is the possibility of checking the functionality of the system S before or after use directly on the operating table. The test device TE can be used to check the signal quality of the light effect, in particular the spark discharge, for tissue differentiation for the system and/or to check the analyzing device AE for optical emission spectroscopy. The test device TE can be used to check the signal quality or the quality of the spark discharge or the expected quality of the spark discharge or the analyzing device AE before and after use of tissue differentiation.

Based on the test, the testing device TE can automatically find one or more settings for performing the test. For example, based on the evaluation of the test light effect, it is possible to determine the need to correct the setting of the RF generator for creating the test light effect 44 in order to create the test light effect 44, according to the results of the analysis of which it would be possible to make a more accurate judgment about the operability of the analyzing device AE, and the test can be automatically repeated with the corrected setting. The voltage output by the RF generator 21 is variable in order to prevent the electrode 10 from burning out when generating a spark discharge. In addition, the voltage output by the RF generator 21 is preferably variable in such a way as to ensure the excitation of the required elements and sufficient separation of the spectral lines by intensity relative to the background noise.

On the basis of the test, the testing device TE can automatically set one or more settings of the system S for the intervention or determine, in particular limit, one or more possibilities of such a setting. The one or more settings or setting possibilities are preferably determined on the basis of the test result obtained during the evaluation of the test lighting effect 44. The system S can be designed in such a way that, on the basis of the evaluation of the signal characterizing the light from the test lighting effect 44, it sets the setting or possible settings for the creation of the lighting effect 13 occurring during the intervention, the reception of the light from the lighting effect 13 occurring during the intervention, the conversion of the received light from the lighting effect 13 occurring during the intervention into an electrical signal and/or the analysis of this signal. In this way, on the basis of the test result, it is possible by means of the testing device TE to specifically influence the generation and/or the analysis of the signal obtained from the lighting effect 13 generated during the electrosurgical intervention on the patient's body. This makes it possible to ensure that, according to the conditions of the intervention, light effects 13 are created, which make it possible to obtain the result of the analysis with a certain information content, in particular with a certain accuracy.

The invention proposes a testing device TE for testing, in particular calibrating, an analyzing device AE intended for analyzing the light effects 13, 44 caused by the operation of a high-frequency surgical instrument 11. The testing device TE comprises a testing device 24 (in simple embodiments of the invention, this may mean that the testing device is a testing fixture) configured to create a test plasma light effect, the light from which is received by a light receiver 14. In embodiments of the invention, the testing device 24 is configured to create a test plasma light effect 44 due to the fact that by means of an instrument 11 located at a discharge distance from the testing device 24 or closer to it, a test plasma light effect 44 is created between the testing device 24 and the instrument 11. The testing device 24 is preferably designed and intended so that it can be located and used during the preparation and/or performance of a planned operation. The testing device TE is preferably part of a high-frequency surgical system S comprising a high-frequency surgical instrument 11 and an analyzing device AE for analyzing the light effects 13, 44 caused by the operation of the high-frequency surgical instrument 11. The testing device 24 preferably serves to perform a functional test (operability test) before and/or during a planned operation and/or to determine a suitable setting of the analyzing device AE and/or other devices of the high-frequency surgical system S by creating a test light effect 44 on or in the testing device 24, preferably at the test surface 26 of the testing device 24. This makes it possible to check whether the analyzing device AE is ready for operation during an operation and/or thereby makes it possible to improve the readiness of the analyzing device AE for operation. A method 100 for testing, in particular for calibrating, an analyzing device AE intended for analyzing light effects 13, 44 generated by a high-frequency surgical instrument 11 is also proposed. The method 100 includes creating a test light effect 44 between a test device 24 and an electrode 10. The light from this test light effect 44 is received by a light receiver 14. The method 100 is preferably carried out by a member of the operating team, in particular a surgeon or an operating assistant.

List of reference designations:

10 electrode,

10a rod,

10b head/tip,

10 insulation,

11 tool,

11a handle,

12 tissue/patient organism,

13 light effect/plasma arising from the intervention,

14 optical fiber/light receiver,

15 hose/line,

16 light receiving cone,

17 light receiver input,

18 bit distance,

19 adapter,

Channel 20,

21 high frequency generator/surgical unit,

22 neutral electrode,

23 block of analysis,

23a device,

24 test fixture,

25 counter electrode,

26 test surface,

27 evaluation block,

28 signaling device,

29 sterile zone,

30 non-sterile zone,

31 line,

32 line,

33 purge system,

34 foot switch,

35 keys

36 spacer element

37 holder,

38 hole,

39 cavity,

40 wall,

41 outlets,

42 exit,

43 additional resistor,

44 test light effect,

45 tip of the counter electrode,

46 groove,

S system,

E high frequency surgical device,

AE analyzing device,

TE test device,

W angle,

And the distance,

MA minimum distance,

L line,

H high frequency current,

Li light,

Sg status signal,

M Wednesday,

Sc shielding gas,

100 way,

101 steps of the method,

102 step method,

Step 103 of the method.

Claims (16)

1. A test device (TE) for calibrating an analyzing device (AE) intended for analyzing light effects (13, 44) caused by the operation of a high-frequency surgical instrument (11), containing a test fixture (24) designed with the possibility of creating a plasma test light effect, the light from which is received by a light receiver (14), wherein the test device (TE) is designed with the possibility of determining the calibration of the analyzing device (AE) based on the determined characteristics of the light from the test light effect (44). 2. The testing device (TE) according to claim 1, wherein the testing device (24) has a testing surface (26) for creating a testing light effect (44) between the electrode (10), in particular the electrode (10) of the high-frequency surgical instrument (11) and at least one testing surface (26). 3. A test device (TE) according to one of the preceding claims, in which the test fixture (24) is designed with the possibility of its placement in a sterile operating area (29). 4. A testing device (TE) according to any one of the preceding claims, comprising an evaluation unit (27) designed in such a way as to evaluate, on the basis of the characteristics of the light received when creating the test light effect (44) by means of the testing device (24), whether the analyzing device (AE) is operational and/or to output to the user a signal or value by which the user can evaluate whether the analyzing device (AE) is operational. 5. A test device (TE) according to any one of the preceding claims, designed in such a way that, by means of a test light effect (44), the sensitivity of the analyzing device (AE) is determined at least at one wavelength and/or the transmittance of the analyzing device (AE) at at least at one wavelength. 6. A test device (TE) according to any of the preceding claims, designed to determine, from the light characteristics of the test luminous effect (44), signatures calculated from intensities at more than one wavelength or in more than one partial spectrum. 7. The test device (TE) according to claim 6, wherein each signature is calculated based on the ratios of the intensities of selected spectral lines characterizing the parts of the material of the test surface (26) and/or the electrode (10) and/or the atmosphere between the electrode (10) and the test surface (26) that have passed into the plasma state. 8. A test device (TE) according to one of the preceding claims, wherein the test fixture (24) comprises at least one substance selected on the basis of its emission spectrum. 9. A test device (TE) according to any one of claims 2 to 8, wherein the test fixture (24) has at least two test surfaces (26). 10. A test device (TE) according to any of the preceding claims, in which substances also found or presumably contained in the biological tissue (12) being examined or exposed to are purposefully included in the test device (24) to create a test light effect (44) with the same detectable characteristics as those determined for the light effect (13) created by the action of a high-frequency surgical instrument (11) on the biological tissue (12). 11. A test device (TE) according to any one of the preceding claims, designed in such a way that, on the basis of a test carried out using the test device (TE) and by means of a test light effect (44), it sets a value or a range of values of at least one parameter - for example a control and/or evaluation parameter, in particular a parameter for acting on biological tissue using a high-frequency surgical instrument (11) for an analyzing device (AE), a test device, a test fixture (24), a high-frequency surgical instrument (11) and/or a high-frequency surgical device. 12. The testing device (TE) according to any one of claims 2 to 11, designed to automatically recognize the approach of the electrode (10) to the testing surface (26) or the position of the electrode (10) at the testing surface (26) to create a testing light effect (44) and, on the basis of this, select or change at least one setting and/or setting possibility of the testing device (TE), the analyzing device (AE), the high-frequency surgical instrument (11) and/or the high-frequency surgical device. 13. The testing device (TE) according to any one of claims 2-12, wherein the testing fixture (24) is configured to set a minimum distance (MA) between the electrode (10) and the testing surface (26) of the testing fixture (24), and/or the testing device (TE) is configured to set an atmosphere between the electrode (10) and the testing surface (26) of the testing fixture (24). 14. A test device (TE) according to any one of paragraphs. 2-13, in which the test fixture (24) is configured to set the orientation of the high-frequency surgical instrument (11), the mounting device (19) for attaching the light receiver (14) to the high-frequency surgical instrument (11) or to its component (11a), the electrode (10) and/or the light receiver relative to the test surface (26), for example by designing the test fixture (24) in such a way as to guide the movement of the high-frequency surgical instrument (11) and/or the light receiver when the high-frequency surgical instrument (11) and/or the light receiver are inserted into the test fixture (24) to ensure that the high-frequency surgical instrument (11) and/or the light receiver automatically occupy a position in which the high-frequency surgical instrument (11) and/or the light receiver have a predetermined orientation relative to the test surface (26), in particular formed on the counter electrode (25) of the test devices (24). 15. A system for high-frequency surgical action on biological tissue (12), comprising a high-frequency surgical apparatus (21), a high-frequency surgical instrument (11) connected to it, a testing device (TE) according to one of the preceding paragraphs, an analyzing device (AE) for analyzing the light effects (13, 44) caused by the operation of the high-frequency surgical instrument (11) and received by a light receiver (14), and an installation device (19) intended for fastening the light receiver (14) to the high-frequency surgical instrument (11), or to its component (11a) by the user of the high-frequency surgical instrument (11), or his assistant. 16. A method (100) for calibrating an analyzing device (AE) intended for analyzing light effects (13, 44) created by the action of a high-frequency surgical instrument (11) on biological tissue (12), characterized in that a test light effect (44) is created between the test device (24) and the electrode (10), the light from which is received by the light receiver (14), and the calibration of the analyzing device (AE) is determined based on the determined features of the test light effect (44).

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