Test equipment

Abstract

According to the invention, a test device (TE) is described for testing, in particular calibrating, an analysis device (AE) for analyzing a light phenomenon (13, 44) caused by an HF surgical instrument (11). The test device (TE) has a test object (24), wherein the test object is configured to generate a plasma test light phenomenon, the light of which can be received by a light receiving unit (14). Furthermore, a method (100) is described for testing, in particular calibrating, an analysis device (AE) for analyzing a light phenomenon (13, 44) generated by an HF surgical instrument (11). The method (100) according to the invention includes generating a test light phenomenon (44) between the test object (24) and an electrode (10). The light of the test light phenomenon (44) is received by the light receiving unit (14). The method (100) can preferably be carried out by a member of a surgical team, in particular a surgeon or a surgical assistant.

Description

Technical Field

[0001] The present invention relates to the field of analysis of optical phenomena caused by electrosurgical actions on tissue. Background Art

[0002] The article “Real-time tissue differentiation based on optical mission spectroscopy for guided delectrosurgical tumor resection” by Spether et al., published in the specialist journal BIOMEDICAL OPTICS EXPRESS, describes a preclinical study in the framework of which optical phenomena were generated between a tissue sample taken from a surgically removed organ of a patient and an instrument and subsequently investigated.

[0003] A surgical device with an instrument for acting on biological tissue under the condition of generating light phenomena is known from EP 2659846 A1. The device has an analysis device for determining the light characteristics of the light (or light, i.e. Licht) acting on the electrical tissue and a discriminator device for associating the light generated during the action with the tissue characteristics of the biological tissue subjected to the action. EP2659846A1 suggests storing the reference spectrum or typical light characteristics of healthy and diseased tissues, different tissue types, etc. in a database. The database can be static, that is to say, filled with corresponding data before the operation begins. It is also feasible to obtain or readjust data before or during the operation. For example, it can be arranged that as long as the surgeon reliably cuts in a determined tissue (e.g., in a healthy tissue), at least one light characteristic that occurs is stored as a rated quantity. The deviation from the rated quantity identified afterwards can be detected by the discriminator device to generate a signal. The device can further process and transmit the signal. In general, it can be said that the discriminator device compares a preset or patient-individual reference spectrum or individual optical features of the spectrum with the measured spectrum or individual optical features thereof and generates a signal indicating a change in tissue type or property as a function of the deviation. The patient-individual optical features, such as the patient-individual reference spectrum, can be recorded and stored either at the beginning of the operation or once or multiple times during the operation.

[0004] US2009 / 0088772 A1 discloses a surgical instrument carried by a robot, which may include one or more optical fibers. The optical fiber can be used to transmit and receive photons and can be configured to provide not only excitation light but also to transmit scattered photons to an analysis unit (e.g., a spectrophotometer). Using the optical fiber, an optical emission spectrum can be run to facilitate the detection of specific chemical species. The analysis unit can be connected to a computer to facilitate the input of parameters for calibrating the spectral function of the instrument or for diagnostic testing. The calibration of the spectrophotometer can be performed using a standard, such as a standard signal of a known solution or tissue chemical composition.

[0005] An instrument for electrosurgery on biological tissue is known from EP 2815713 A1. The instrument has electrodes and light conductors, which are connected to a light inflow window formed by a fluid body. The light conductor is connected to a light analysis device in order to receive the light formed at the electrode in the case of HF surgery and provide it to the light analysis device.

[0006] The light receiving unit (eg optical fiber) can become contaminated during operation, in particular due to deposits of liquids, smoke, vapors and particles. In addition, the system consisting of the analysis device with light receiving unit and analysis unit and the instrument with special electrodes and HF generator can actually be used for the first time in a specific operation.

[0007] In HF generators (energy sources for HF sparks), the standard allows, for example, a standard deviation of + / -20% in HF output power. The specific resistance of biological tissue varies greatly, with fat tissue having 3.3x10 7 Ohm mm 2 / m, muscle tissue has 2.0x10 6 Ohm mm 2 / m, while blood has only 1.6x10 6 Ohm mm 2 / m. The implementation of different cutting or coagulation modes (for example in the case of spark control) has an influence on the light emission of the HF spark at the biological tissue. The specific light emission then also depends on the settings of the HF generator or the instrument and additionally on the electrode shape.

[0008] The implementation of the HF-OES system from the formation of the optical path to the analysis unit has a significant influencing factor on the signal quality of the light. The optical interface at the plug-in connection outside and inside the analysis device may significantly deteriorate the transmission. Contamination of the optical fiber, for example during the manufacturing process, may deteriorate or even completely hinder the transmission. Incorrect mechanical fixation of the optical fiber may significantly deteriorate the transmission. Errors in the connection of the analysis device to the surgical instrument and / or in the alignment with each other may result in the following, that is, the available light signal cannot be received by the analysis device. Similarly, in the clinical use of HF-OES systems (high-frequency optical emission spectroscopy systems), the signal quality of the HF spark may change significantly due to, for example, contamination of the optical fiber with blood and thus distort tissue differentiation or make tissue differentiation impossible.

[0009] Due to the energy input, in the case of optical emission spectra for tissue differentiation using HF sparks, large changes in intensity may occur, especially HF sparks of different intensities. The high temperature at the beginning of the spark discharge causes a pressure increase, which in turn explosively increases the cross-section of the discharge channel. The peak temperature is reduced as a result. In the case of spark excitation, the temperature and pressure around the plasma are not constant. The impedance of the plasma between the electrode and the tissue changes. In order to be able to compare HF-OES-spectra with each other, the HF-OES-spectra must meet quality standards accordingly, so that the tissue spectrum can be classified into evaluable and non-evaluable spectra. It does not form an absolute value of the signal quality, but only forms the ratio of each spectral line to each other. HF sparks are not only formed between the electrode tip and the tissue, but also due to contamination, sparks can also be formed on the side outside the observation window of the optical fiber, so that, for example, only a portion of the light emission that is smaller than that in the case of no contamination is coupled into the glass fiber.

[0010] Testing or calibration of individual components of the system can be effective only to a limited extent due to the large number of possible combinations of electrodes, optical waveguides, evaluation units, HF generators, control parameters, etc. Summary of the invention

[0011] The object of the present invention is to specify an improved embodiment for a system having an evaluation device for analyzing light phenomena caused by HF surgical instruments.

[0012] This object is achieved with a test device according to the invention for testing, in particular calibrating, an analysis device for analyzing light phenomena caused by HF surgical instruments. The test device includes at least one test object. The test object is configured to generate a plasma test light phenomenon, the light of which can be received by a light receiving unit. The test device is configured to test, in particular calibrate at least part of the analysis device or the entire analysis device. The analysis device can have a light receiving unit (for example an optical fiber) and an analysis unit, wherein the light receiving unit is connected to the analysis unit. The analysis device is used in particular for tissue differentiation (tissue differentiation), for example between healthy and malignant tissue.

[0013] The test object of the test device provides a test surface outside the body (the body of any human or animal being treated with the device), so that the test method using the test device is not carried out on the human or animal body.

[0014] The test object preferably consists of non-biological material. In particular, the test object preferably has no human or animal tissue or preferably no human or animal tissue is provided as the test object or as part of the test object. This naturally does not exclude that the test object may be contaminated with tissue residues or the like in the case of intraoperative testing.

[0015] The plasma test light phenomenon (test light phenomenon for short) is understood to be, for example, a spark or a stationary plasma as it is generated by means of a test object. The light phenomenon may contain electromagnetic waves in the infrared, visible and / or ultraviolet range of the electromagnetic spectrum. The test device may be configured to record and analyze the infrared, visible and / or ultraviolet components of the spectrum relative to the test light phenomenon. The light receiving unit that receives the plasma test light phenomenon may be a test light receiving unit that is connected or partially connectable to an analysis unit of an analysis device. Preferably, however, the light receiving unit is a light receiving unit of an analysis device. Because preferably, the analysis device is tested by means of the test device in combination with the instrument and particularly preferably with an HF surgical instrument for supplying the instrument with HF energy, it is also used in the case of a specific operation, in its preparation or during which the analysis device is tested, for example, calibrated.

[0016] A medically educated member of the surgical team (e.g. a surgical assistant or a surgeon) can ensure the basic functionality of the analysis device by means of the test device, preferably before or during the operation, by generating a test light phenomenon with the aid of a test object and receiving the light by means of a light receiving unit. The test device is preferably configured to output the result of the functional test, for example "test successful" (i.e. the analysis device is operable) and / or "test unsuccessful" (i.e. the analysis device is not operable), to the surgical staff by means of a corresponding signal or the disappearance of a signal, in particular an optically, acoustically or tactilely perceptible signal. Thus, for example, situations in which an optical fiber of the analysis device is contaminated or damaged or in which the analysis device is not correctly assembled can be revealed.

[0017] Further exemplary advantageous features and embodiments of the testing device according to the invention, the method according to the invention and the system according to the invention are apparent from the following description:

[0018] The test object may have a test surface for generating a test light phenomenon between an electrode, preferably an electrode of the instrument, and the test surface. The test surface may be formed by a counter-electrode opposite the electrode. The test surface may be conductively connected to the HF surgical instrument and / or the neutral electrode (when it is a monopolar instrument).

[0019] The test device is preferably provided for clinical use. The test device is preferably provided for use during an intraoperative phase of an operation with the surgical instrument. Particularly preferably, the test object can be arranged and / or is arranged in a sterile operating area. Thus, testing (in particular calibration) of the analysis device by means of the test device just before or during the operation can be realized particularly easily.

[0020] Preferably, the test device has an evaluation unit which is configured to evaluate whether the analysis device is operational based on the light characteristic (light characteristic or characteristics) of the received light by means of the light phenomenon generated by the test object. The evaluation unit can, for example, be part of the analysis device.

[0021] The light characteristics used to evaluate whether the analysis unit is operable can be, for example: the light power at all received wavelengths, not scattered in the spectrum or integrated, the light power at one wavelength or a plurality of wavelengths different from each other (the spacing is greater than the wavelength resolution of the test device), the intensity of each spectral line, the intensity of a spectral line group, the time curve of the test light phenomenon, the polarization of the light of the test light phenomenon, a typical spectrum, a spectral profile, a signature obtained from the spectrum and / or a signature obtained from the spectrum, the spectral profile and / or the spectral line of the light of the test light phenomenon. These signatures can be obtained as calculated quantities from algorithms, formulas, relational tables or other evaluation rules. In particular, these signatures are: the intensity ratio of the selected spectral lines, the ratio between different items, the sum and / or the difference, wherein these items are again: the sum, difference, product, integral over a partial spectrum and / or other items of the intensity of different spectral lines or partial spectrum or light characteristics or signatures derived therefrom.

[0022] The evaluation criteria can be, for example, the signal-to-noise ratio or the signal-to-background ratio at a certain wavelength, a group of wavelengths, a spectral segment, the entire spectrum, the ratio of the intensities at different wavelengths and / or groups of wavelengths and / or spectral segments. In a simple case, for example, the intensity of the light of the test light phenomenon determined by means of the test device can be determined by comparison with a threshold value whether sufficient light can be received by the light receiving unit so that the light analysis device is operational.

[0023] Alternatively or additionally, a signature of the intensity ratio of selected spectral lines of the light of the test light phenomenon can be calculated, for example, and / or in the case of calculating the signature, the uncertainty due to, for example, noise or background can be determined. For example, each signature can be calculated from a spectral line that is characteristic for the transition to the plasma state of the test surface and / or the electrode and / or the material of the atmosphere between the electrode and the test surface, selected by the intensity ratio. If the uncertainty, for example, from the ratio of the signature relative uncertainty is greater than a threshold value, for example, a positive test of the analysis device can be initiated, wherein the evaluation unit generates a corresponding evaluation signal. In the case of a negative test output, the evaluation unit can generate a corresponding additional evaluation signal or no evaluation signal or alternatively the evaluation signal output disappears in the case of a positive test result. Based on this evaluation signal or other evaluation signals, a particularly audible, visual or tactilely perceptible signal is output to the user of the surgical instrument and / or the analysis device and / or the evaluation signal can be used to control the analysis device test system, the analysis device, the HF surgical instrument and / or the HF surgical instrument. Based on the evaluation signal, parameters or parameter ranges of the test device, the analysis device, the HF surgical instrument and / or the HF surgical instrument can be preset automatically by the system, for example. This means that the HF surgical system can be automatically calibrated (with or without release of the automatic calibration by a user) based on a test of the test device using the HF surgical instrument, the HF surgical instrument, the test device, the analysis device and / or, if necessary, further devices, in that at least one setting of at least one device of the HF surgical system is selected or changed based on the test. The test device can alternatively or additionally output a recommendation for at least one setting of at least one device of the HF surgical system based on the test to the user, who can then decide to calibrate the HF surgical system according to the recommendation.

[0024] Based on this evaluation signal, for example, the output of a signal by the analysis device can be prevented and / or a statement about the analysis accuracy of the analysis device can be derived and output to a user. The evaluation result can then be, for example, whether the analysis device is fully functional, is functioning with sufficient accuracy and / or with what accuracy the analysis device can function.

[0025] The test device is preferably configured to determine and preferably evaluate the sensitivity of the analysis device in at least one wavelength, a group of wavelengths, a part of the spectrum or the entire spectrum and / or the transmittance of the analysis device in at least one wavelength, a group of wavelengths, a part of the spectrum or the entire spectrum based on the test light phenomenon. The sensitivity is the amount of electrical signals in the analysis device caused by the received light of the test light phenomenon compared to the intensity of the light of the test light phenomenon. The transmittance is the ratio of the intensity at the light output end of a light receiving unit (e.g. an optical fiber) to the intensity at the light input end of the light receiving unit. The transmittance can be affected, for example, by contamination, damage of the input end, for example, including between the light input end and the light output end (where the light signal is converted into an electrical signal) and / or, for example, in the case of a coupling, between the light input end and the output end. Comparative sensitivities and / or transmittances can be stored in a database with which the determined sensitivity and / or the determined transmittance of the test device can be compared. Since the test object is the light receiving unit of the analysis device when determining the transmittance, the analysis unit of the analysis device can be used in the case of determining the transmittance or another analysis unit can be connected to the light receiving unit according to the test.

[0026] Preferably, the test object has at least one or at least two different materials selected by means of emission spectra. This can produce highly effective analysis results when the material, for example, produces a light signature of a type that is expected, for example, in the tissue to be treated, and / or when the light signature and / or the marker are determined with such precision from the test light phenomenon to which the material can contribute, from which light signatures and / or markers interfering with the light phenomenon and / or the type of the light phenomenon contributing to the intervention can be inferred.

[0027] The test object may have a predetermined composition. Preferably, the composition and / or shape of the test object, in particular the test surface, is selected with the aid of diagnostic criteria for a (hypothetical) disease, such as a (hypothetical) tumor, and / or a surgical intervention on the tissue to be treated.

[0028] Preferably, the test object contains targeted substances which are also present and / or estimated in the tissue to be examined and / or treated, in order to generate a test light phenomenon from which light characteristics can be determined, which can also be generated in the case of HF surgery due to the action of light phenomena (intervention light phenomena) on the tissue via the instrument.

[0029] Preferably, the electrode that the user brings into proximity with the paired electrode in order to produce the test light phenomenon is selected specifically based on its composition for producing the test light phenomenon. For example, the electrode may be selected based on the expected contribution of the substance or material of the electrode to the test light phenomenon and / or light phenomenon and / or based on the light characteristics of the test light phenomenon and / or light phenomenon based on the presence of one or more components of the electrode. The electrode may be selected based on the composition of the electrode in view of the expected contribution relative to the test light phenomenon and / or light phenomenon depending on the clinical indication for surgical intervention.

[0030] The test object may have at least two different test surfaces. The test surfaces may differ in terms of their shape, composition, physical state (solid, liquid) and the like. The composition of the test surfaces may differ in particular in the form of type and / or in their absolute and / or relative amounts. Thus, the influence of electrodes and / or electrode materials can be determined and / or the interference light phenomenon can be calculated. The test surfaces may differ in that they consist of different materials. For example, test surfaces consisting of different metals (especially pure metals or alloys), different solutions may be contained in the same or different materials (e.g. sponge or felt materials). The test may comprise that the test light phenomenon is generated sequentially against at least two different test surfaces.

[0031] The test device is preferably configured to determine a correction of the analysis device from a determined light feature of the test light phenomenon. For example, the determined light feature is compared with a light feature stored in a database in order to determine the correction of the analysis device. Preferably, based on the correction at least one parameter of the test device, the analysis device, in particular the light receiving unit and / or the analysis unit, the HF surgical instrument and / or the HF surgical instrument is selected or changed. Preferably, the system is configured to select or change at least one parameter of the test device, the analysis device, in particular the light receiving unit and / or the analysis unit, the HF surgical instrument and / or the HF surgical instrument or other devices or components of the system based on the correction.

[0032] Preferably, at least one value or value range of at least one parameter of the test device, the test object, the analysis device and / or the HF surgical device, in particular the HF surgical instrument and / or the HF surgical instrument for supplying the HF surgical instrument, such as a control and / or evaluation parameter, is preset by the test device based on the test with the test device by means of the test light phenomenon. In particular, based on the test with the test device by means of the test light phenomenon, a value or a value range of a parameter of at least one of the mentioned devices of the system can be preset, which has an influence on the operation of the system composed of the mentioned devices in the case of treated tissue. Obviously, values ​​or value ranges of the parameters are preferred, which make the desired HF surgical treatment result possible, but lead to an improved analysis of the intervention light phenomenon by means of the analysis device.

[0033] The test object is preferably provided for determining a minimum distance between an electrode brought into the vicinity of a counter-electrode by a user of the test device for producing a test light phenomenon and a test surface of the test object, between which the test light phenomenon is to be produced.

[0034] Preferably, the test device is configured to determine 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 generated between the electrode and the test object.

[0035] The test object is preferably configured to determine the orientation of the electrode and / or the light receiving unit, which is brought into the vicinity of the counter electrode in order to generate the test light phenomenon, relative to the test surface. This can occur, for example, in that the test object is configured to guide the instrument and / or the light receiving unit when the instrument and / or the light receiving unit is inserted into the test object, so that the instrument and / or the light receiving device automatically assumes a position such that the instrument and / or the light receiving device has a determined orientation relative to the counter electrode.

[0036] The test device preferably provides a light receiving unit for shielding against ambient light in case of receiving light for testing the light phenomenon.

[0037] The aforementioned measures can be used individually or in any desired (sub)combination to create conditions for the test in order to achieve particularly effective test results.

[0038] Preferably, a test device for the instrument and the analysis device is determined, which can be combined with the instrument by the user of the instrument (e.g., a surgeon, a surgical assistant, or other members of the surgical team) in preparation for surgery or during surgery. The light receiving units of the instrument and the analysis device can preferably be fixed to each other by the user of the instrument before and / or during surgery in order to determine the position of the light receiving unit of the analysis device relative to the instrument. In the case of such a surgical system consisting of an instrument and an analysis device that can be fixed to each other by the user of the instrument, an inoperable analysis device may occur due to misoperation, damage, contamination, mismatch between the instrument and the analysis device, and / or an analysis device that allows special settings of the HF surgical device and / or the analysis device so that the analysis device can work. Such a situation can be revealed and corrected based on the test with the help of the test device.

[0039] According to the invention, a system is described which has a device for fixing a light receiving unit of an analysis device to an instrument or a part of an instrument. The device is preferably designed so that the light receiving unit can be connected to the instrument by a surgical user of the surgical instrument or his assistant, particularly preferably during surgery.

[0040] The device can be, for example, an adapter in which or on which an optical fiber is fixed or can be fixed as a light receiving unit. The adapter can be connected to an instrument, for example a handle of the instrument, in order to determine the position of the light receiving unit relative to the electrodes of the instrument. With the aid of a test device, it can be checked whether the light receiving unit thus combined with the instrument can function correctly.

[0041] The method according to the invention is a method for testing, in particular calibrating, an analysis device for analyzing light phenomena generated by HF surgical instruments acting on biological tissue. The method comprises the generation of a test light phenomenon between an electrode and a test object that is not a human or animal body, and the reception of the light of the test light phenomenon by a light receiving unit. The method is then in particular not carried out at the human or animal body. The method can be carried out by a test device described herein and / or a system described herein with a test device and / or a HF surgical device. In particular, single or multiple arbitrary method steps can be carried out by or with the aid of a test device described herein and / or a system described herein. As an alternative to carrying out the test remotely from the object or completely at the patient, the user of the analysis device can carry out a test, in particular for confirming the functionality of the analysis device or calibrating the functionality, by generating a test light phenomenon with the aid of a test object dedicated thereto.

[0042] The method can be performed in preparation for surgery just before or during surgery, more precisely by a user of the instrument, such as a surgeon or a surgical assistant. The test device, in particular the test object, is preferably provided for use in preparation for and / or during surgery by a physician or a physician's assistant who intends to perform a planned (planned) surgery using the HF surgical instrument.

[0043] In one embodiment of the method, at least one test light phenomenon can be generated and evaluated between the electrode and at least two different test surfaces.

[0044] Preferably, a system with an HF surgical instrument, HF surgical tools and an analysis device is used for the test, which is also used for the surgery.

[0045] Preferably, the same settings are used for the instrument for the test, or the test is performed with the same settings that are also to be used for the operation with the instrument and / or settings derived therefrom. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Further advantageous features and embodiments are apparent from the dependent claims as well as from the following description and the drawings, which are shown schematically and by way of example:

[0047] Figure 1a A graphical illustration showing the positioning of a light receiving unit relative to an electrode or a light phenomenon of a positioned light receiving unit in a situation where the electrode acts on tissue,

[0048] Figure 1b A schematic illustration showing the electrode tip in the light-receiving cone of an optical fiber,

[0049] Figure 2a An exemplary instrument in the form of a handle with a distally arranged electrode inserted into an adapter is shown, which has a light receiving unit in the form of an optical fiber,

[0050] Figure 2b Shown with other electrode forms such as in Figure 2a A cross section of a combination of an adapter and an instrument, Figure 3 An exemplary embodiment of a system of an HF surgical device with an analysis device and a test device is shown. Figure 4 A further embodiment of a system with an HF surgical device, an analysis device and a testing device is shown. Figure 5 An embodiment of a test object is shown,

[0051] Figure 6a Another embodiment of a test object is shown,

[0052] Figure 6b1 and 6b2 A further exemplary counter-electrode and electrode are shown in each case,

[0053] Figure 6c An exemplary counter electrode is shown, and

[0054] Figure 7 An embodiment of the method according to the invention is shown. DETAILED DESCRIPTION

[0055] Figure 1a The figure shows how an electrode 10 can be used, by way of example, in a surgical instrument 11. The electrode 10 is arranged on a tissue 12 to be treated in a patient. A means for holding the electrode 10, such as a handle, is provided. Figure 1a The electrode 10 has a shaft 10a and a head or tip 10b, which can be made of titanium or tungsten, for example. An insulating part 10c is mounted on the electrode 10 adjacent to the head or tip 10b in order to more accurately determine the region of the electrode 10 in which plasma 13, in particular sparks or arcs, is generated between the electrode 10 and the tissue 12. The electrode 10 used in the case of generating plasma interference light phenomena 13 is preferably a partially insulated cutting electrode, as is used in high-frequency (HF) surgery. The electrode 10 preferably has a burning resistance relative to sparks of at least titanium or tungsten.

[0056] An optical fiber 14 or a line 15 in a hose 15 is arranged at an acute angle W relative to the electrode 10. The optical fiber 14 and the hose 15 are fixed in their position relative to the electrode 10. A light receiving cone 16 is drawn, which contains the light received by the optical fiber 14 and can be passed to an analysis unit for analyzing the light (in Figure 1a As shown, the tip or head 10b of the electrode 10 is arranged in the light receiving cone 16. This can also be seen in the schematic cross-sectional view. Figure 1b The light receiving cone 16 in the electrode 10 is identified. Light phenomena 13 occurring between the electrode 10 and the tissue 12, such as, for example, stationary plasma (for example in the case of argon plasma condensation), arcs or sparks which are formed and disappear in rapid succession if necessary, are thus formed in the light receiving cone 16. Its light rays, which have infrared, visible and / or ultraviolet radiation, are thus partially received by the optical fiber 14 and transmitted to the analysis unit.

[0057] The hose 15 is used to guide a fluid, in particular a gas (e.g. CO2), to the distal end of the hose 15, where the fluid flows out in the direction of the electrode 10. The fluid flow is used to reduce contamination of the optical fiber 14, to clean the optical fiber 14, to blow off vapor or particles formed, due to the electrosurgical action on the tissue 12.

[0058] However, it is possible that, despite the fact that the outflowing CO2 stream is limited in its flow rate to preferably a maximum of 1 liter / minute, so as not to displace the tissue 12 to be treated, particles or vapors are still separated at the light input end 17 of the optical fiber 14 and the transmittance of the optical fiber 14 is limited. This limitation can possibly also be noted only for certain wavelengths, for example in the infrared, visible and / or ultraviolet range of the electromagnetic spectrum. Due to contamination of the electrode 10, the light input section 17 of the optical fiber 14 can be partially covered. Due to contamination of the electrode 10, the shape of the light phenomenon 13 can be partially changed, because due to contamination, parts of the tip or head 10b can be electrically insulated. Contamination can not only occur based on vapor or flying particles. It is also possible that the surgeon accidentally brings the tissue 12 into contact with the electrode 10. Because the maximum ignition distance that can exist for igniting the light phenomenon between the electrode 10 and the tissue 12 can, for example, only be a few millimeters between the distal end of the electrode 10 and the tissue 12, when the light phenomenon is ignited in an environment filled with an inert gas, such as argon, or even only a few tenths of a millimeter, when the light phenomenon is ignited in an environment filled with CO2. Contaminants can also cause changes in the spectrum of the light phenomenon.

[0059] How much light of the optical phenomenon 13 can be captured by means of the optical fiber 14 depends largely on its position relative to the electrode 10. This depends, for example, on the distance A between the light input end 17 and the tip of the electrode 10 and / or on the optical phenomenon 13, the arrangement of the light input end 17 around the electrode 10 and the angle W between the optical fiber and the electrode 10, among other things.

[0060] Figure 2a An HF surgical instrument 11 in the form of an HF applicator with a handle 11a and preferably replaceable electrodes 10 is shown. The applicator 11 is inserted into an adapter 19. Alternatively, the applicator 11 and the adapter 9 can be fastened to each other, for example arranged side by side. The adapter 19 contains an optical fiber 14 fastened therein or thereto and can provide a channel 20 for the output CO2 flow. The adapter 19 serves to fix the optical fiber 14 and the instrument 11 to each other. The surgeon or other members of the surgical team can connect the adapter 19 to the instrument 11, for example during surgery.

[0061] The adapter 19 supports the determination of the position of the optical fiber 14 relative to the electrode 10. However, many variant possibilities remain. For example, the electrode 10 is preferably replaceable. Different shapes of the tip or head 10b of the electrode 10 are possible. For example, needle-shaped and spoon-shaped electrodes 10 are known. Figure 2b For example, the hook-shaped electrode 10 is used as Figure 2a An alternative to the electrode 10 shown in is used. Likewise, the electrode 10 can have different lengths and thus protrude from the adapter 19 to different extents. However, the position, that is to say the spacing and / or orientation of the light input end 17 relative to the electrode 10 and thus also the position of the light phenomenon 13 relative to the light receiving cone 16 depends on the length and shape of the electrode 10 protruding from the adapter 19.

[0062] The determination of the position of the optical fiber 14 relative to the electrode 10 is thus particularly reliable when the HF applicator 11 is matched to the adapter 19. However, it is conceivable to accidentally or intentionally use an HF applicator 11 to which the adapter 19 is not matched. The correct position of the optical fiber 14 relative to the electrode 10 may then no longer be ensured.

[0063] Furthermore, it should be noted that the light receiving unit, for example the optical fiber 14, may be damaged. Likewise, the coupling between the light receiving unit 14 and the evaluation unit or between the parts of the light receiving unit 14 in the case of a multi-part light receiving unit 14 may also fail and lead to an impaired transmission of light.

[0064] The electrode 10 or the instrument 11 is supplied by a HF (high frequency) generator (in Figure 1a2) are supplied with electrical energy. In the case of HF generators, the standard allows a standard deviation of the HF output power of + / -20%. Depending on the desired form of HF surgical intervention, such as cutting, coagulation, devitalization, hot infusion, etc., different powers are required, the waveform of the HF voltage supplied to the electrode 10, etc. The characteristics of the electrode 10 with the HF voltage supplied to it are called modes or operating modes. This operating mode has an influence on the light emission of HF light phenomena 13 (such as HF sparks) at the biological tissue 12.

[0065] In addition, the specific resistance of biological tissue 12 varies greatly. Fat tissue has, for example, about 3.3*107 Ohmmm2 / m, muscle tissue has 2.0x106 Ohm mm2 / m, while blood, on the other hand, has only 1.6x106 Ohmmm2 / m. Similarly, the medium (aerosol, air mixture) between electrode 10 and tissue 12 depends entirely on the application. Depending on whether the intervention is performed open surgically, endoscopically or laparoscopically, the moisture between electrode 10 and tissue 12 can, for example, vary greatly. The ignitability (ionization) of plasma 13 is very significantly affected by moisture or liquid at the activated electrode 10. The atmosphere between electrode 10 and tissue 12 can be determined in part by the HF surgical device, depending on whether, for example, argon or CO2 gas is output into the region between electrode 10 and tissue. The breakdown voltage depends on the gas form. If, for example, spark 13 is ignited in an argon atmosphere, the spark is different from when spark 13 is ignited in dry air or in a CO2 atmosphere.

[0066] In summary, it can be recognized that the form of the light phenomenon 13 or its light characteristics, in particular its shape, intensity, spectral composition, etc., depends very clearly on the individual actual situation for a specific surgical intervention and can change during the intervention. The amount of electrical signals generated by the light through the light phenomenon 13, which is captured by the optical fiber 14 and / or can be converted into an analysis device, also depends entirely on the actual situation in the surgical situation.

[0067] An improved design of a system S according to the invention for HF surgical treatment (in particular cutting and / or coagulation) of tissue 12 using optical emission spectroscopy is provided. Figure 3 . The system S (HF surgical system) has an HF surgical device E with an HF surgical instrument 11, here in the form of an applicator 11 with a handle 11a and an electrode 10 fixed at the distal end of the handle 11a, and an HF generator 21 for supplying the instrument 11. The HF surgical device E is a device for monopolar HF surgery, in which the current circuit is closed via a neutral electrode 22 fixed to the patient. Alternatively or additionally, the HF surgical device E is provided for bipolar HF surgery.

[0068] Furthermore, the system S has an analysis device AE for analyzing optical phenomena, in particular stationary plasmas, arcs, sparks, between the electrode 10 and the tissue 12 of the patient's body by means of a light emission spectrum in the infrared, visible and / or ultraviolet range of the spectrum. The analysis device AE has an optical fiber 14 as a light receiving unit and an analysis unit 23 connected to the optical fiber 14. The optical fiber 14 can be connected according to Figure 1a It is fastened to the instrument 11 by means of an adapter 19. The optical signal transmitted by means of the optical fiber 14 from the location where the intervention takes place is converted by the system S into an electrical signal.

[0069] The test device TE for testing, in particular calibrating the analysis device AE, has a test object 24, which provides a counter electrode 25 with a test surface 26. By means of the device 11, a plasma test light phenomenon, for example in the form of a spark or a continuously maintained plasma, can be generated between the device 11 and the test object 24. The test object 24 is provided in this respect for generating a plasma light phenomenon. The counter electrode 25 can be at the same potential as the neutral electrode 22. The counter electrode 25 can be connected, for example, to the HF generator 21 via the neutral electrode 22. In addition, the test device TE has an evaluation unit 27. The evaluation unit 27 can be integrated into the device with the analysis unit 23 or be part of the analysis unit 23. The analysis unit 23 and / or the evaluation unit 27 can be integrated in different devices. The analysis unit 23 and / or the evaluation unit 27 can also be distributed on a plurality of devices and, for example, be formed by one or more software modules implemented in one device or in a plurality of devices. In addition, the test device TE can have a signal unit 28 for outputting information to a user of the system S visually, acoustically and / or tactilely. The signaling unit 28 is connected to the evaluation unit 27 in order to be prompted by the latter to output information, if necessary.

[0070] The sterile area 29 of the operating room is demarcated from the non-sterile area by a dashed line L. As shown, the test device TE is partially arranged in the sterile area 29 . In particular, the test object 24 is arranged in the sterile area 29 .

[0071] With the help of Figure 3 The test device TE can check whether the system S, in particular the analysis device AE, is operable and / or the system S, in particular the analysis device AE, can be prepared so that the system S or the analysis device AE can be operated. In particular, it can preferably be checked whether a tissue differentiation by means of the light emission spectrum at the light phenomena caused by the action of the electrodes 10 on the tissue 12 can be performed by means of the analysis device AE. Alternatively, the test device TE can be used to find the settings for the system S, in particular the analysis device AE, by means of tests so that it can operate with a predetermined accuracy.

[0072] Figure 4 The diagram illustrates a system S for HF surgery using optical emission spectroscopy. Figure 4 The implementation form can be based on Figure 3 A specific embodiment of the system S or another embodiment of the system S according to the present invention. Figure 4 , medium flows, power and signals (HF flow H, light Li, status signal Sg and cleaning medium M (e.g. CO2)) are plotted in FIG. 1 . The HF electrode 10 is supplied with electrical HF energy via a line 31 in a handle which is connected to the HF surgical instrument 21 via a line 32. An HF flow flows between the HF electrode 10 and the patient's body 12. In this process, a light phenomenon 13 is generated, wherein its light is received by an optical fiber 14 and supplied to an analysis unit 23. Via a cleaning system 33, a cleaning medium, in particular CO2, is output to the intervention point between the electrode 10 and the tissue. The cleaning system 33 can be controlled by means of a foot switch 34. The HF surgical device E can be controlled by means of a button 35 on the handle 11a and / or on the surgical instrument 21 (see FIG. 1 ). Figure 2a ) to control.

[0073] In the case of testing with the test device TE, current flows between the electrode 10 and the test surface 26. The cleaning medium can be output in order to determine the atmosphere between the electrode 10 and the test surface 26. The light of the optical spark is received by the light receiving unit 14 and transmitted to the analysis unit 23. The analysis unit 23 can output a status signal to the HF applicator 11 or the adapter 19.

[0074] As in Figure 4 As shown in , the test device TE can have a plurality of test surfaces 26. The test surfaces 26 can be distinguished from each other. The test surfaces 26 can be distinguished in particular in their composition, shape, size, state of the test surface 26 (e.g. liquid, solid), etc. Each test surface 26 can have an alloy or a pure metal (purity greater than or equal to 95%). The alloys of different test surfaces 26 can be distinguished from each other and / or the pure metals contained in different test surfaces 26 can be distinguished from each other.

[0075] Figure 5 An exemplary test object 24 is shown in cross-section. The test object 24 may be, for example, Figure 3 The test object 24 has a support 37 for a test surface 26 and a spacer 36. The test surface 26 is provided by a reference electrode or a counter electrode 25. The counter electrode 25 can be, for example, a metal plate or a metal foil.

[0076] The spacer 36 provides an opening 38 into which the adapter or instrument 11 is inserted or onto which the adapter or instrument 11 can be placed. The spacer function ensures that the distance between the instrument 11, the handle and / or the adapter and the test surface 26 does not exceed a maximum value.

[0077] Preferably, the opening 38 is provided for guiding the instrument 11, the adapter 19 and / or the electrode 10 and / or the light receiving device 14 so as to determine a determined position of the electrode 10 and / or the light receiving device 14 relative to the counter electrode 25. Preferably, the shape of the opening 38 on the one hand and the shape of the instrument 11, the electrode 10, the light receiving device 14 and / or the adapter 19 on the other hand are coordinated with one another so that when the shapes engage one another, the position of the instrument 11, the light receiving unit 14, the electrode 10 and / or the adapter 19 relative to the test surface 26 is determined.

[0078] A space 39 for plasma (plasma space) is formed between the opening 38 of the spacer 36 and the test surface 26. The space 39 is formed by electrically insulating walls 40 (except for the counter electrode 25). The test object 24 has at least one outflow opening 41, through which the gas flowing from the adapter into the space 39 can be discharged, so that a certain pressure of the protective gas Sc, such as CO2 or argon, is present in the space 39 or does not exceed a certain pressure. For example, the pipeline 15 can be supplied with argon in the adapter 19 for testing. In addition, the outflow opening 41 can be used to maintain a constant atmosphere by continuous exchange of the medium in the space 39. In Figure 5 As can be seen in FIG. 1 , the electrode 10 belonging to the HF device 11 in combination with the light receiving device 14 protrudes via the distal end of the device 11 or the adapter 19 into the space 39 for the plasma. The optical input end 17 of the optical fiber 14 is opposite to the output end 42 of the adapter 19 or the device 11 (see FIG. 1 ). Figure 2a ) is offset backwards.

[0079] The counter electrode 25 can be connected to the HF generator 21 via a series resistor 43. The electrode 10 is also connected to the HF generator 21 in order to be supplied with HF energy therefrom. Thus, a light event (test light event) 44 is generated between the tip 10b of the electrode 10 and the counter electrode 25.

[0080] The material for the counter electrode 25 or the test surface 26 can be selected specifically based on the clinical indication for the HF surgical intervention. For example, the material can contain the same morphology that is expected in the tissue 12 to be treated, in particular the tissue 12 to be cut and / or coagulated, which is treated in the case of HF surgical intervention.

[0081] Figure 6aAn alternative embodiment of the test object 24 is shown. The test object 24 can be used, for example, in accordance with Figure 3 or 4. The test object 26 is here formed by a sponge or felt 25 which is soaked in a reference solution, in particular a saline solution. A test surface 26 close to the real tissue 12 can thus be created. Into the solution can be placed a material which is to be indicated and / or differentiated according to the test using the test device TE. The solution and / or the material can be selected in a targeted manner based on the clinical indications for HF surgical intervention. Thus, for example, the differentiation of morphology and thus the differentiation of "tissue" according to the test is not performed at the patient's body, but at the material outside the body. The reference solution can be selected in a targeted manner based on the clinical indications for surgical intervention, for example because the determined reference solution contains the morphology which is expected in the tissue 12 in the same way or in specific components, which in the case of HF surgical intervention is partially transitioned into the plasma state and therefore the optical characteristics contribute to the intervention optical phenomenon 13.

[0082] The test surface 26 may be as described in accordance with Figure 5 and Figure 6a The counter electrode 25 may alternatively be a substantially flat surface as in the example of Figure 6b1 and 6b2 The electrode 10 may have a rounded spoon shape ( Figure 5 ), pointed shape ( Figure 6a , Figure 6b1 ) or a spoon-shaped shape with a pointed tip ( Figure 6b2 ). The electrode 10 may have an insulating portion, which leaves the tip or head of the electrode 10 uninsulated. Figure 6c An example of a counter-electrode 25 is shown as a metal plate with a groove 46. Using the electrode shape and the counter-electrode shape, the shape of the test light phenomenon 44 can be predetermined in order to achieve effective test results.

[0083] The counter electrode 25 is preferably flame-resistant when it is intended to be used multiple times. Preferably, however, this flame resistance is less than that of the electrode 10. The test device TE is preferably sterilizable. The test device TE, in particular the test object 24, can be designed for multiple use. The test object 24 or the counter electrode 25 as a single product is preferably formed by means of a soaked sponge or felt 25.

[0084] By means of the system S according to the invention according to at least one of the described embodiments, it is possible to operate, for example, as follows:

[0085] According to e.g. Figure 3The system S of the apparatus 11 or 4 can be arranged by the surgical team for the planned intervention. In particular, the instrument 11 and / or the electrode 10 and / or the test object 24 and / or the test surface 26 or the counter-electrode 25 can be selected for the intervention based on clinical indications. In preparation for an intervention or during an intervention, the user of the analysis device AE can perform a functional test of the analysis device AE in that the user generates a test light phenomenon 44 (according to the apparatus 11) between the electrode 10 of the apparatus 11 and the counter-electrode 25. Figure 7 Step 101 of an embodiment of the method 100 of ). The possible results of the functional test may be, for example, "working" or "not working". For this purpose, the user can insert the instrument 11 into the opening 38 of the test object 24 or place it on the opening 38. The test device TE can be configured to recognize when the instrument 11 and the test object 24 are brought together to produce the test light phenomenon 44. The test device TE can, for example, be configured to recognize when the instrument 11 or the adapter 19 is inserted into or placed in the opening 38. The test device TE can select a preferred determined setting of the system S, in particular the HF surgical device E, based on the recognition of the intended test. For example, the test device TE can exclude a determined otherwise possible setting of the system S for the test or otherwise not make possible a possible setting. Alternatively or additionally, the test device TE is configured to be used as follows, that is, the surgical team can switch the system S into the test mode by means of an operating element (not shown). The user can trigger the generation of the test light phenomenon 44 by himself or the test device TE can automatically trigger the test. The test device TE may have a device (not shown) for identifying the position of the electrode 10, the instrument 11 and / or the adapter at or in the test object 24. Thus, it can be automatically determined, for example, whether the electrode 10, the instrument 11 or the adapter is arranged away from the test surface 26, so that the generation of the test light phenomenon 44 is automatically triggered or the manual trigger is released. The test device TE can be configured to automatically select a suitable setting for generating the test light phenomenon based on the preconditions of the test (for example, the type of electrode 10, instrument 11, HF surgical instrument 21, counter electrode 25 used, etc.). The test setting or the test setting feasibility is selected in such a way that the HF electrode 10 or the optical fiber 14 is not damaged in the case of the test. The HF voltage between the electrode 10 and the counter electrode 25 can be preferably selected, for example. This voltage depends in particular on the shape of the electrode 10, the spacing of the electrodes 10 from each other, the material of the electrode 10 and the counter electrode 25, and the gas surrounding the electrode 10 and the counter electrode 25 in the test object 24. Alternatively or additionally, essentially the same settings of the system S as for the uniform HF surgical intervention can be used to generate the test light phenomenon 44 .

[0086] By triggering the test, a plasma test light phenomenon 44, for example a stationary plasma, an arc or a spark in the case of argon plasma condensation, is formed between the electrode 10 and the counter electrode 25 of the instrument 11, in that the high-voltage pulse ionizes the atmosphere between the electrode 10 and the test surface 26 and thereby makes it conductive. As a result, the path becomes low-impedance and it is configured as a current of several amperes. In the case of spark excitation, for example, the current is interrupted again after several milliseconds, but then restarts after the stop time. The spark sequence depends on the repetition frequency of the generator, for example 20kHz. The current form of the voltage source can be a pure sine or modulated (sinusoidal) voltage shape of, for example, 350kHz. It can use a single pulse, a pulse group with multiple fluctuations, which is correspondingly provided with a repetition frequency, so that, for example, plasma maintenance. Voltage, power or plasma regulation can be used to generate the test light phenomenon 44 or to intervene in the test light phenomenon 13 (therefore, it can represent a light phenomenon caused by actual intervention on the tissue 12 of a patient with the electrode 10). In the case of plasma regulation (also referred to as arc regulation), one or more characteristics of the plasma, such as certain harmonics, are kept constant or within a certain range.

[0087] The light of the test light phenomenon 44 is partially received by the light receiving device 14 (step 102) and transmitted to the device 23a of the analysis unit 23 (see Figure 4 ) is arranged to convert the light transmitted via the optical fiber 14 into electrical signals which are supplied to the test device TE for further evaluation by the evaluation unit 27. The device 23a can convert the light into individual contributions to one or more electrical signals in a wavelength-specific manner, such as a spectrometer.

[0088] In order to evaluate the functionality of the evaluation device AE, for example, a signal power can be determined based on the test light phenomenon 44, which is present at the evaluation unit 27. The evaluation unit 27 can, for example, compare the power, for example the total power or the wavelength-specific intensity, with a reference value in order to check the transmission of the light of the test light phenomenon 44 to the device 23a for converting the optical signal into an electrical signal. In this case, the energy input can be taken into account for generating the test light phenomenon 44 based on the HF voltage and the HF current.

[0089] The test is then particularly effective when the electrode 10 is aligned with respect to the test surface 26 or the counter electrode 25 with the aid of the test object 24 and / or the position of the electrode 10 with respect to the test surface 26 and / or the counter electrode 25 is determined. Alternatively or additionally, the adapter 19 can be aligned with respect to the test surface 26 or the counter electrode 25 with the aid of the test object and / or the position of the adapter 19 with respect to the test surface 26 and / or the counter electrode 25 is determined. If the test light phenomenon should, for example, be too weak or should not ignite at all, this can indicate an unsuitable position of the optical fiber 15 with respect to the electrode 10. This is an example of this, i.e. operating errors or other errors in the case of a combination of the optical fiber 15 with the instrument 11 or an unsuitable configuration of the instrument 11 with the electrode 10 for light analysis can be revealed with the aid of the test device TE.

[0090] The effectiveness of the test can be additionally or alternatively increased when the test object 24 is arranged for testing at the light input 17 of the light receiving unit 14 away from external light from the surroundings. Based on this, ambient light is not received together, which means that in any case, an amount of light from the surroundings that does not affect the test with the test device TE is received. Alternatively or additionally, the test device TE can be coordinated with the operating field lighting (not shown). The analysis unit 23 and / or the evaluation unit 27 are preferably insensitive in such a spectral range in which the operating field lighting works. In this way, glare of the evaluation unit 27 and / or the analysis unit 23, in particular its discriminator unit (not shown), which is used for the association of light features with respect to tissue features, is avoided.

[0091] For defined plasma generation, in particular spark ignition, a defined atmosphere in which the ignition is achieved, for example an argon atmosphere with high purity, is advantageous. Low PPM oxygen and water vapor or vapors of organic compounds in argon (which are always present in the case of biological tissue 12) can sensitively interfere with the discharge. Therefore, the atmosphere in which the plasma is ignited for the generation of the test light phenomenon 44 is preferably determined by means of the test device TE. This relates in particular to the composition and / or pressure of the atmosphere. The test object 24 provides an ignition space (plasma space) 39. For example, during the execution of the test, the plasma space 39 is filled with a gas, such as CO2 and / or argon, in the test object 24. A constant pressure can be provided in the ignition space 39. When the spark ignition is performed under protective gas conditions (such as argon), other influences by the environment (operating microclimate) can be suppressed as much as possible. The signal intensity of the light emission can be positively enhanced by an inert gas, such as argon. The test object 24 can, for example, have an interface (not shown) for supplying the plasma space 39 with argon, so that, for example, in order to test the generation of the light phenomenon 44, the plasma space can be filled or filled with an inert gas, in particular argon, in contrast to the cleaning device, for example, which otherwise operates with CO2, in particular in the case of HF surgical interventions.

[0092] According to the design according to the invention, a specific analysis device AE can be tested, which is to be used or is used for analysis in the case of surgical intervention. In particular, the specific light receiving unit 14 and the analysis unit 23 can be checked for functionality, more precisely by means of a plasma test light phenomenon 44, between the electrode 10 used in the case of intervention and the counter-electrode 25 without action on the patient's body. The test conditions are thus very close to the actual use based on components that are as identical as possible and to the plasma ignited by the loading of the electrode 10 of the instrument 11 as in the case of actual intervention. With the help of this test, an unsuitable position of the optical fiber 14 relative to the electrode 10 (for example due to incorrect placement of the handle in the adapter), the use of an unsuitable electrode 10, a contaminated or damaged optical fiber 14, an insufficient connection between sections of the optical fiber 14 or between the optical fiber 14 and the device 23a for converting optical signals into electrical signals can be excluded. Likewise, covering of the electrode 10 due to possible contamination, the test light phenomenon 44 (and thus possible intervention light phenomenon 13) due to an unfavorable form of contamination or an unfavorable electrode form can be excluded. The test device TE can be used to check whether the signal strength for evaluating the effective force of the received light signal is sufficient and can be utilized in the analysis of the light signature due to the HF intervention in the tissue 12 caused by the intervention light phenomenon 13 .

[0093] To stimulate the test light phenomenon 44, an HF surgical instrument 21 of an HF surgical device E is preferably used, which also supplies the electrode 10 during intervention on the patient's tissue 12. For this purpose, the sample to be analyzed (test surface 26, counter electrode 25) and the HF electrode are connected to the generator 21.

[0094] The testing device TE can transmit a status signal (for example “the analyzing device is operational” or “the analyzing device is not operational”) to the surgical user visually, acoustically and / or tactilely by means of the signaling unit.

[0095] The test device TE can be configured to recommend measures to the user, if necessary, in order to enable an improvement in the analysis by the analysis device AE, in particular in order to obtain a stronger signal. For this purpose, the test device TE can, for example, determine the likelihood for one or more limitations, i.e., which are responsible for a possible negative test result.

[0096] By means of the test method 100, the wavelength dependency of the transmittance of the light receiving unit 14 in the case of a correction can be determined and, if necessary, one or more corrections (factors) can be determined, which can be taken into account in the case of evaluating the signal based on the test light phenomenon 44 and / or the signal based on the intervention light phenomenon 13. The determination, ascertainment and / or consideration can be performed automatically by the test device TE and / or the analysis device AE.

[0097] In order to determine the wavelength dependency of the transmittance, a test light phenomenon 44 is preferably generated in whose spectrum at least two or more spectral lines are present and / or a plurality of test light phenomena 44 are preferably generated in whose spectrum each at least one spectral line is present, wherein at least one spectral line of the test light phenomenon 44 is distinguishable from the other test light phenomena 44. Such a test light phenomenon 44 can be generated in a targeted manner when the composition of the test surface 26 is selected accordingly by means of the form of the morphology in the composition and thus the characteristic spectral lines and their frequencies.

[0098] Based on the plasma generated for the test light phenomenon between the electrode 10 and the counter electrode 25, the material of the counter electrode 25 and / or the electrode 10 is reduced (evaporated, split into atoms and ionized) and thus forms (atoms, molecules, ions thereof) consisting of the materials of the counter electrode 25 and the electrode 10 are generated, which are also present in the plasma at this time. The energy supply causes the following, that is, these forms emit radiation. It generates light with a spectrum of parts in the infrared, visible and / or ultraviolet range, which parts have spectral lines characteristic for the relevant forms with respect to the position and intensity of the spectrum.

[0099] This is used by the analysis device AE for tissue differentiation, because when a plasma is ignited between the electrode 10 and the tissue 12 in the case of a surgical intervention, the morphology of the tissue material is drawn into the plasma formed by the tissue 12 and enters the plasma, wherein the morphology provides a characteristic contribution to the spectrum of the light of the intervention light phenomenon 13. For each new clinical indication, the most different trajectory elements are decisive so that tissue differentiation can be performed during surgery.

[0100] It is therefore advantageous if the composition of the test surface 26 or the counter electrode 25 is selected in particular on the basis of the clinical indication for the intervention, in particular on the basis of the expected composition of the tissue 12 to be treated HF-surgery and / or the composition is selected specifically on the basis of the emission spectrum during the transition of the material of the counter electrode 25 into the plasma state. Materials for the counter electrode 25 or the test surface 26 can be selected such as one or more metals (in particular pure metals or alloys) or liquids (reference solutions) with selected forms (reference substances) contained therein, which also occur and / or are expected to occur uniquely in the biological tissue 12 to be examined, such as Ca, K, Mg, Na, P, Cl, Cd, Zn, Cr, Co, Fe, I, Cu, Mn, Mo, Se, F, Si, As, Ni, Sn and V. Thus, a test light phenomenon 44 can be generated, from which a light characteristic can be determined, which can also be formed due to the intervention light phenomenon 13 by the action of the instrument 11 on the tissue 12. Test subject 24 may be specifically selected based on clinical indications, for example by a surgical team.

[0101] The test object 24 may have two different test surfaces 26 which differ in their composition. It may, for example, be a plurality of metal plates with test surfaces 26 formed of different pure metals. Thus, the influence of the material of the electrode 10 can be calculated, since the electrode material can also provide a contribution to the spectrum of the test light phenomenon 44 and / or the intervention light phenomenon 13.

[0102] Likewise, the electrode 10 can be selected specifically based on its composition for the generation of the test light phenomenon 44, in particular by means of an expected light signature, which contributes to the test light phenomenon 44 and / or the intervention light phenomenon 13 based on the material of the electrode 10. The spectrum of the contribution of the material of the electrode 10 relative to the test light phenomenon 44 and / or its light signature can, for example, be used as a reference spectrum or reference light signature. This is particularly important when the electrode 10 is selected based on its material, in particular for a clinical indication, which should be performed with the system S in the case of a subsequent operation. The spectral lines of the material of the electrode 10 preferably do not overlap with the spectral lines of the material of the tissue 12 to be examined and / or the material of the counter electrode 25, so as not to distort the test results and / or spectral results obtained with the help of the light of the test light phenomenon 44 or the intervention light phenomenon 13. The electrode material and the material of the test surface 26 and / or the counter electrode 25 can be different, so that a clear association of the light signature or the marker or the track element can be performed.

[0103] The test of the functionality of the analysis device AE may additionally or alternatively include the determination of the accuracy, for example the signal-to-noise ratio, over the entire spectrum of the test light phenomenon 44, over a selected range of the spectrum and / or in the case of one or more specific spectral lines, with which the signal intensity based on the test light phenomenon 44 at one or more wavelengths can be determined, in addition to or as an alternative to the test described above for determining the signal strength. Preferably, the accuracy for one or more spectral lines is determined, which occurs both in the spectrum of the test light phenomenon 44 and in the spectrum of the intervention light phenomenon 13. Because the possible method for tissue differentiation applied by means of the analysis unit 23 is based on the determination of a marker according to the light characteristics of the spectrum of the light of the intervention light phenomenon 13 and the determination of tissue characteristics directed to the marker based on the marker. In order to distinguish between healthy tissue 12 and pathological tissue 12, for example, each marker can be calculated from a selected spectral line that is characteristic for the vaporized part of the biological tissue 12. With the determined accuracy, it can be determined by the test device TE whether tissue differentiation via the analysis device AE is possible.

[0104] Additionally or alternatively, a differentiation of one or more materials can be performed per test, which are used in a targeted manner in one or more test surfaces 26. The test device TE can, for example, be configured to determine a signature from a light feature of the light of the test light phenomenon 44, which is calculated from the intensity or partial spectrum of multiple wavelengths, wherein each feature is preferably calculated from a selected spectral line that is characteristic for the transition of the material of the test surface 26 and / or the electrode 10 and / or the portion of the atmosphere between the electrode 10 and the test surface 26 into the plasma state. The test device TE can have a device (not shown) for receiving information about the composition of the test surface 26, in order to transmit such information to the test device TE. The test device TE can compare the differentiation result based on the analysis of the light of the test light phenomenon with the information obtained by the test device TE via the device for receiving information about the composition of the test surface 26.

[0105] Based on the test results, the testing device TE can output information about the test results to the user and / or identify one or more possible measures, i.e., how to increase the accuracy or how the tissue differentiation can be improved (e.g. by replacing or cleaning one or more selected components of the system S).

[0106] When determining the ratio between the intensities of the spectral lines in the light of test light phenomenon 44 and / or intervention light phenomenon 13 , the wavelength dependency of the transmission determined by test light phenomenon 44 can be taken into account by means of a correction factor.

[0107] The system S, in particular the analysis device AE, can be calibrated with the aid of the spectrum of the test light phenomenon 44 in order to thereby take into account fixed influencing factors for the transmission of the light through the input end of the optical fiber 14 to the unit by means of which the light is converted into an electrical signal. In the case of a too strong deviation of the light power upward or downward, this can be detected by the system S and compensated, for example, by adapting the integration time or, for example, by a correction factor of the analysis unit 23. The calibration of the entire system S with all relevant components that can have an influence on the signal quality of the light spark can thus be checked and adapted. The system S can be calibrated with the test device TE. In the case of calibration, it is understood that the accuracy of the system S is determined in the case of a test and preferably based on the test with the test device TE at least one setting or parameter of the system S, in particular the analysis device AE and / or the HF surgical device E is found and set so that the desired accuracy is achieved with the analysis device AE.

[0108] The test results determined from the light received from the test light phenomenon 44 can be obtained before or during the operation and stored as a reference for the rest of the operation. With the help of this reference, in particular the reference signal, for example spectral lines in the light (caused by the intervening light phenomenon 13 between the electrode 10 and the tissue 12) can be identified.

[0109] The test device TE should advantageously be able to be placed in the sterile area 29, so that even after the use during surgery, a check of the transmission is also possible. It is advantageous for the user to check the function of the system S directly before or after the use at the operating table. The test device TE can be used to check the signal quality of the optical spark, in particular the optical spark for tissue differentiation of the system, and / or for checking the analysis device AE for optical emission spectroscopy. The test device TE can be used to check the signal quality or the spark quality or the previous spark quality of the optical spark or the analysis device AE before and after the use of tissue differentiation.

[0110] Based on this test, the test device TE can automatically find one or more settings for the test. For example, based on the test light phenomenon, it can be determined that the settings of the HF generator for generating the test light phenomenon 44 must be adapted in order to generate the test light phenomenon 44, based on which the functionality of the analysis device AE can be more accurately described and the test can be automatically repeated with the adapted settings. The voltage emitted by the HF generator 21 is variable in order to prevent the electrode 10 from burning in the event of spark generation. In addition, the voltage emitted by the HF generator 21 is preferably variable in such a way that the desired elements are excited and the spectral lines are sufficiently highlighted by the basic noise in terms of intensity.

[0111] Based on this test, the test device TE can automatically determine one or more settings of the system S for the intervention or determine, in particular, limit the setting feasibility scheme. One or more settings or setting feasibility schemes are preferably determined based on the test results obtained by evaluating the test light phenomenon 44. The system S can be configured to determine the settings or possible settings for generating the intervention light phenomenon 13 based on the evaluation of the light of the test light phenomenon 44, the reception of the light of the intervention light phenomenon 13, the conversion of the received light of the intervention light phenomenon 13 into an electrical signal and / or the analysis of the signal. Based on the test results, the influence obtained by the test device TE on the generation and / or analysis of the signal based on the light phenomenon 13 can then be carried out in a targeted manner, which is generated based on the electrosurgical intervention on the patient's body. It can therefore be envisaged that, based on the preconditions in the case of the intervention, an intervention light phenomenon 13 is generated, which makes it possible to have an analysis result with a certain effectiveness, in particular a certain accuracy.

[0112] According to the invention, a test device TE is described for testing, in particular calibrating, an analysis device AE for analyzing light phenomena 13, 44 caused by an HF surgical instrument 11. The test device TE has a test object 24 (which can be included in simple embodiments of the invention in that the test device is formed by the test object), wherein the test object is provided for generating a plasma light phenomenon, the light of which can be received by a light receiving unit 14. In these embodiments, the test object 24 is provided for generating a plasma test light phenomenon 44 in that a plasma test light phenomenon 44 can be generated between the test object 24 and the instrument 11 by means of an instrument 11 arranged in the ignition distance or close to the test object 24. The test object 24 is preferably provided and arranged in a defined manner and is intended for use in the context of preparation and / or execution of a planned operation. The test device TE is preferably a device of an HF surgical system S, which has an HF surgical instrument 11 and an analysis device AE for analyzing light phenomena 13, 44 caused by the HF surgical instrument 11. The test object 24 is preferably used to perform functional tests and / or to determine suitable settings of the analysis device AE (before the planned surgery and / or during the surgery) and / or other settings of the HF surgical system S generated by test light phenomena 44 at or in the test object 24, preferably at a test surface 26 of the test object 24.

[0113] In this way, it can be checked whether the analysis device AE can be used in the case of surgery and / or the usability of the analysis device AE can be improved thereby. In addition, a method 100 for testing, in particular calibrating, an analysis device AE for analyzing light phenomena 13, 44 generated by an HF surgical instrument 11 is described. The method 100 includes generating a test light phenomenon 44 between a test object 24 and an electrode 10. The light of the test light phenomenon 44 is received by a light receiving unit 14. The method 100 can preferably be carried out by a member of the surgical team, in particular a surgeon or a surgical assistant.

[0114] List of reference numerals:

[0115] 10 electrodes

[0116] 10a handle

[0117] 10b Head / tip

[0118] 10c Insulation

[0119] 11 Equipment

[0120] 11a handle

[0121] 12 Patient's tissue / body

[0122] 13 Intervention Light Phenomenon / Plasma

[0123] 14 optical fiber / optical receiving unit

[0124] 15 hose / pipeline

[0125] 16 light receiving cones

[0126] 17 Optical input port

[0127] 18 ignition spacing

[0128] 19 Adapter

[0129] 20 channels

[0130] 21HF generator / surgical instruments

[0131] 22 Neutral electrode

[0132] 23Analysis Unit

[0133] 23a device

[0134] 24 Test subjects

[0135] 25 paired electrodes

[0136] 26 test surfaces

[0137] 27 evaluation units

[0138] 28 signal units

[0139] 29 Sterile Area

[0140] 30Non-sterile areas

[0141] 31 pipeline

[0142] 32 pipelines

[0143] 33. Cleaning system

[0144] 34 foot switch

[0145] 35 keys

[0146] 36 Spacer

[0147] 37 bracket

[0148] 38 openings

[0149] 39 Space

[0150] 40 walls

[0151] 41 Outflow opening

[0152] 42 Output

[0153] 43 Series resistor

[0154] 44 Test light phenomenon

[0155] 45 Tip of paired electrode

[0156] 46 slots

[0157] S System

[0158] E HF Surgical Devices

[0159] AE analysis device

[0160] TE test equipment

[0161] W angle

[0162] A Spacing

[0163] MA minimum spacing

[0164] L Straight Line

[0165] H HF current

[0166] Li rays

[0167] Sg status signal

[0168] M Medium

[0169] Sc shielding gas

[0170] 100 Methods

[0171] 101 Steps

[0172] 102 Steps

[0173] 103 Steps

Claims

1. A test device (TE) for calibrating an analysis device (AE) for analyzing light phenomena (13, 44) caused by HF surgical instruments, wherein: The test device (TE) has a test object (24), wherein the test object (24) is configured to generate a plasma test light phenomenon, the light of which can be received by a light receiving unit (14), and wherein the test device (TE) is configured to determine a calibration of the analysis device (AE) from a determined light characteristic of the test light phenomenon (44).

2. The test device (TE) according to claim 1, wherein: The test object (24) has a test surface (26) for generating a test light phenomenon (44) between an electrode (10) and the test surface (26).

3. The test device (TE) according to claim 2, wherein: The electrode (10) is the electrode (10) of the instrument (11).

4. The test device (TE) according to any one of claims 1 to 3, wherein: The test object (24) can be arranged in a sterile operating area (29).

5. A test device (TE) according to any one of claims 1 to 3, comprising an evaluation unit (27), which is configured to evaluate whether the analysis device (AE) is operable based on light characteristics of the received light of the test light phenomenon (44) generated by the test object (24), and / or output a signal or value to a user, based on which the user can evaluate whether the analysis device (AE) is operable.

6. The test device (TE) according to any one of claims 1 to 3, wherein: The test device (TE) is configured to determine the sensitivity of the analysis device (AE) at at least one wavelength and / or the transmittance of the analysis device (AE) at at least one wavelength based on the test light phenomenon (44).

7. The test device (TE) according to claim 2 or 3, wherein: The test device (TE) is configured to determine, from the optical characteristics of the light of the test light phenomenon (44), a sign calculated from the intensities of a plurality of wavelengths or partial spectra, wherein each sign is calculated from a spectral line selected according to an intensity ratio which is characteristic for the transition of the material of the test surface (26) and / or the electrode (10) and / or the portion of the atmosphere between the electrode (10) and the test surface (26) into a plasma state.

8. The test device (TE) according to any one of claims 1 to 3, wherein: The test object (24) contains at least one substance which is selected based on its emission spectrum.

9. The test device (TE) according to claim 2 or 3, wherein: The test object (24) has at least two different test surfaces (26).

10. The test device (TE) according to any one of claims 1 to 3, wherein: The test object (24) contains a targeted substance which is also present or assumed in the tissue (12) to be examined or treated in order to generate a test light phenomenon (44) from which a light characteristic can be determined, which can also be determined from the light phenomenon (13) generated by the instrument (11) acting on the tissue (12).

11. The test device (TE) according to claim 10, wherein: The test device (TE) is configured to preset a value or a value range for at least one parameter in dependence on the test light phenomenon (44) based on a test with the test device (TE).

12. The test device (TE) according to claim 11, wherein: The parameters are control and / or evaluation parameters for treating the tissue using the instrument (11), and are parameters of the analysis device (AE), the test device, the test object (24), the HF surgical instrument, the HF surgical instrument and / or the remaining devices of the system (S) for HF surgical intervention.

13. The test device (TE) according to claim 2 or 3, wherein: The test device (TE) is configured to automatically detect a position close to the electrode (10) or to detect a position of the electrode (10) at the test surface (26) in order to generate a test light phenomenon (44), and based on this, select or change one or more settings and / or setting possibilities of the test device (TE), the analysis device (AE), the instrument (11), the HF surgical instrument (21) and / or other devices for HF surgical intervention.

14. The test device (TE) according to claim 2 or 3, wherein: The test object (24) is configured to determine a minimum distance (MA) between an electrode (10) and a test surface (26) of the test object (24), and / or wherein the test device (TE) is configured to predetermine an atmosphere between the electrode (10) and the test surface (26) of the test object (24).

15. The test device (TE) according to claim 2 or 3, wherein: The test object (24) is configured to determine the orientation of the instrument (11), an adapter for the instrument (11), an electrode (10) and / or a light receiving unit relative to the test surface (26) in that the test object (24) is configured to guide the instrument (11) and / or the light receiving unit when the instrument (11) and / or the light receiving unit are introduced into the test object (24) so ​​that the instrument (11) and / or the light receiving unit automatically assume a position so that the instrument (11) and / or the light receiving unit have a determined orientation relative to the counter electrode (25).

16. A system with a test device (TE) according to any of the preceding claims and a device (19), wherein the device is used to fix a light receiving unit (14) of an analysis device (AE) for optical analysis to the instrument (11) or to a component (11a) of the instrument (11) by a surgical user of the surgical instrument or his assistant.

17. A method (100) for calibrating an analysis device (AE) which is configured to analyze light phenomena (13, 44) generated by an HF surgical instrument when acting on biological tissue (12), wherein: The method (100) comprises generating a test light phenomenon (44) between a test object (24) and an electrode (10), the light of which is received by a light receiving unit (14), and wherein a test device (TE) is configured to determine a calibration of the analysis device (AE) from a determined light characteristic of the test light phenomenon (44).

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