Theragnostic system and method for theragnostics with tissue identification

Abstract

FIELD: medicine.SUBSTANCE: application describes a theragnostic system comprising a surgical station and a data storage and processing device that contains, in a suitable storage facility, a large volume of data combining patient data and treatment data, for example, in the form of electrical and optical characteristics (E, O). Electrical characteristics (E) are derived from the electrical parameters of voltage and current used to power the tool. Optical properties are derived from the light from the spark generated when it hits the fabric. Combining electrical (E) and optical (O) characteristics into a single data set, such as a database containing other characteristics such as tissue characteristics and, optionally, patient characteristics, makes it possible to automatically determine with great reliability whether an instrument is acting on healthy or diseased tissue. Prediction accuracy can be improved using machine learning by adding histological data to datasets in addition to electrical (E) and optical (O) characteristics. In a preferred embodiment of the invention, this data is accumulated in a cloud connected to multiple surgical stations. In this way, data obtained at different surgical stations can be sent to the cloud.EFFECT: improving the reliability and accuracy of identification of tissue affected by an electrosurgical instrument.15 cl, 6 dwg

Description

[0001] The present invention relates to an integrated therapy and diagnostic system (theragnostic system) for the treatment (therapy) and identification (diagnosis) of tissues. In particular, the invention relates to a theragnostic system for determining tissue characteristics, in particular its benign or malignant nature, during surgical intervention. Furthermore, the invention relates to a method for evaluating data before, during, and / or after surgery to obtain information about the tissue being treated.

[0002] Publication EP 2659846 B1 discloses a device comprising a surgical instrument with an electrode connected to a generator that supplies a high-frequency alternating voltage to the electrode. A spark (spark discharge) is maintained between the electrode and biological tissue, emitting light. This light is received by a light-receiving device and fed to an analytical device, which performs spectral analysis. Based on the resulting spectrum, a conclusion can be drawn—through specialized analysis, including, if necessary, pattern recognition and comparison with light characteristics stored in a database—whether the tissue is benign or malignant. This information can be presented to the surgeon.

[0003] Furthermore, publication US 2007 / 0213704 A1 discloses a medical instrument for cold ablation of tissue using very short, high-frequency sparks. The light emitted by the sparks is fed to a spectral analyzer to generate control signals based on the resulting spectra and enable tissue differentiation.

[0004] Publication WO 2011 / 055369 A2 describes a catheter for ablating plaques in blood vessels. A spark used to remove plaques generates light, which is transmitted via an optical fiber to a sensor. This sensor detects a phosphorus line, allowing it to distinguish plaques from living cells. EP 3319313 A1 describes a network capable of fusing data from multiple points. This data includes camera images and other sensor data, as well as data on the circumstances of medical interventions.

[0006] Further information on the prior art can be obtained from publications DE 10392791 T5, DE 19860689 C2, US 2009 / 0326383 A1, DE 4231677 A1, WO 02 / 19243 A2, US 6026323, WO 03 / 020119 A2, EP 0650694 A1, DE 102020105853 A1 and US 2019 / 0223728 A1.

[0007] In the practical implementation of tissue recognition by evaluating the light emitted by the spark, uncertainties arise, which make it difficult to reliably recognize tissue.

[0008] The objective of the invention is to improve automatic tissue recognition during surgical intervention on biological tissue.

[0009] This problem is solved by means of the system and method described in paragraphs 1 and 15 of the invention formula.

[0010] The theragnostic system proposed in the invention includes at least one surgical station and a data storage and processing device that ensures the processing of data obtained at the surgical station.

[0011] The surgical station comprises at least: a light-receiving device for receiving light emitted by a spark (spark discharge) occurring between an electrode of an electrosurgical instrument and biological tissue; a light analyzer configured to determine at least one optical characteristic of the received light; a generator for producing an electrical voltage that supplies the electrode of the electrosurgical instrument with an electric current; a detector device for determining at least one electrical characteristic; and an output device.The data storage and processing device is configured to determine a fabric mark based on at least one optical characteristic, and if reliable identification of the fabric is not possible only based on at least one optical characteristic, to determine the fabric mark based only on at least one electrical characteristic or based on at least one electrical characteristic and at least one optical characteristic, and also with the capability of transmitting the fabric mark for output to the output device.

[0012] The data storage and processing device may be part of a surgical station or a separate device installed remotely from the surgical station and connected to the latter via a data network. In particular, the theragnostic system may also include multiple surgical stations connected or configured to be connected to a common data storage and processing device via a data network.

[0013] As noted above, the surgical station includes at least one electrosurgical instrument suitable for surgically affecting biological tissue. For this purpose, the instrument comprises at least one electrode. Furthermore, the surgical station includes at least one generator for supplying the instrument, in particular its electrode, with an electric current suitable for achieving a surgical effect, typically a high-frequency current with a frequency exceeding 100 kHz, preferably 300 kHz or more. The voltage provided by the generator and applied to the instrument's electrode typically ranges from a value exceeding 100 volts to a value of several thousand volts and, like the current, has a correspondingly high frequency. The high-frequency voltage can be selectively modulated to achieve various surgical effects.In addition, various other parameters can be adjusted, such as power, maximum current, modulation, etc. Such generator presets for achieving different surgical effects are called "operating modes."

[0014] As noted above, the surgical station also includes a light-receiving device configured to receive light emitted by a spark or spark discharge occurring between the electrode and the tissue. This light is incident on a light analyzer, which is also part of the surgical station and is configured to record at least one optical characteristic of the received light. The optical characteristic may be, in particular, a spectral characteristic, such as a characteristic spectrum, a section of the characteristic spectrum, individual wavelengths of the characteristic spectrum, or one or more parameters derived from the spectrum. Furthermore, the surgical station includes a detector device for obtaining an electrical characteristic.The electrical characteristic may be a current value, a current fluctuation, a voltage applied to an electrode, a voltage fluctuation, a current and / or voltage modulation, a resulting crest factor, a tissue impedance, an impedance of a series circuit consisting of a tissue resistance and a spark resistance, a power consumption, an energy consumption, a phase angle between a current and a voltage, or a calculated value obtained from one or more of the mentioned parameters.

[0015] Both optical and electrical characteristics are fed to a data storage and processing device. The data storage and processing device determines a tissue marker (identifier) ​​based on the optical characteristics and, if necessary and as a supplement or alternative, on the electrical characteristics by comparing it with existing data and transmits it to the surgical station output device for display. To determine the marker, i.e., to identify the tissue, the system proposed in the invention primarily uses optical characteristics. If reliable tissue identification based solely on these characteristics is impossible, the system uses electrical characteristics secondarily and as a supplement or alternative. This makes tissue identification significantly more reliable and more widely applicable than using only optical or electrical characteristics.

[0016] The tissue marker is a signal indicating whether the tissue being exposed and in contact with the spark is malignant or benign. The output device may be an optical, audible, or tactile device, allowing the surgeon or other specialist to determine whether the electrode is interacting with healthy or malignant tissue. In the case of tumor resection, this provides the surgeon with information about whether the incision is being made inside or outside the tumor. By utilizing not only optical but also electrical characteristics for tissue identification, particularly electrical characteristics closely related to the spark, the data storage and processing device can provide more selective and accurate tissue recognition than is known in the prior art.

[0017] The light analyzer preferably comprises a spectral analysis device capable of determining (as an optical characteristic) a spectrum, portions of a spectrum, or a parameter derived from a spectrum or portions of a spectrum. For this purpose, the surgical station may include a local data processing device. If the data storage and processing device storing the reference spectra is located outside the surgical station, the optical characteristic is determined locally, and only the optical characteristic, not the entire spectrum, is transmitted to the remote data storage and processing device. This reduces the volume of transmitted data and thereby increases the response speed of the entire system.

[0018] The spectral analysis device may further include a quality evaluation unit that evaluates the reliability of the obtained optical characteristic and assigns it the obtained rating. The quality evaluation unit uses a quality criterion to evaluate the obtained optical characteristic. The quality criterion may depend on the method for obtaining the optical characteristic. For example, the evaluation of the optical characteristic may relate to one or more spectral lines or spectral regions and, in particular, to their maximum intensity, i.e., peaks that stand out from the background noise of the spectrum. Typical peaks may be, for example, the calcium line, the magnesium line, the zinc line, or also bands related to molecular fragments, such as CN, N2 +, CH, CC, NH, etc. If such spectral lines or peaks are only faintly visible above the background noise, the optical characteristic obtained from these peaks is of low quality. If the desired lines are clearly visible, the optical characteristic is of high quality. The quality criterion output by the quality assessment unit can be a digital signal (valid / unreliable) or an analog signal (e.g., a value between 0 and 1), which can be used to evaluate the significance of the optical characteristic.

[0019] In a preferred embodiment of the invention, the data storage and processing device is configured to determine a tissue marker based on an electrical characteristic with a low degree of reliability or without regard to the optical characteristic, if the quality criterion indicates low or no reliability of the optical characteristic. This preserves tissue recognition capability even when using low-quality (i.e., low-characteristic) spectra. Moreover, the data storage and processing device can also be configured to generate a warning signal, which is transmitted to the surgical station and sent to the output device there, alerting the physician of the reduced reliability of the output tissue marker.

[0020] The system proposed in the invention can be implemented as a self-learning system capable of combining various data into a single data set. For example, an input device can be provided at a surgical station, through which data on the type of tissue to be treated (e.g., muscle tissue, adipose tissue, lung tissue, tissue of organs such as the liver, kidneys, etc.) can be entered into a data storage and processing device. The input device can also be provided and configured to record other data, for example, metadata, such as patient data, and to transmit them to the data storage and processing device. The input device is configured to enter specific data by displaying specific data input masks into which the corresponding data can be entered or imported.

[0021] The data storage and processing device may also be configured to record optical and electrical characteristics obtained during surgery. Furthermore, the input device may be configured to input the histological analysis result, which is also transmitted to the data storage and processing device and matched with the optical and electrical characteristics. The resulting raw data set may be verified by the data storage and processing device during further operation and ultimately used as a reference data set for tissue identification in subsequent surgeries. Data sets may be compiled specifically for individual patients or for specific patient types or classes. Patient types or classes may be defined by gender, age, weight, general condition, previous illnesses, drug dependence, or similar criteria.

[0022] A corresponding input device can also be provided outside the surgical station to utilize laboratory data to populate the database. For example, explanted tissues can be subjected to histological examination and experimentally processed in the laboratory using an electrical instrument to determine the resulting electrical and optical characteristics and store them in the database.

[0023] Furthermore, the generator's operation can be controlled with respect to at least one operating parameter based on the optical characteristic. For example, the voltage, current, modulation type, modulation depth, duty cycle in the case of pulse-width modulation, crest factor, power consumption, and / or energy supplied to the biological tissue can be adjusted. Specifically, the generator can be controlled to maximize the optical characteristics, ensuring good reliability of the conclusions drawn based on the optical and electrical characteristics.

[0024] The generator can also be controlled according to the surgeon's preferences to achieve the desired surgical effect, for example, by switching it to the first operating mode. It may be found that in this operating mode, only low-quality optical characteristics can be achieved. In this case, the system may provide the ability to briefly switch the generator to the second operating mode, which is not the surgeon's preferred mode but still provides high-quality optical characteristics. The switch to this operating mode is preferably short enough to prevent the surgeon from subjectively perceiving a change in the response of the instrument they are controlling, or at least from significantly altering the desired surgical effect on the tissue. In the second operating mode, electrical parameters such as voltage, current, power, peak factor, waveform, etc., may be changed for a short time, i.e., less than 100 milliseconds, preferably less than 10 milliseconds, and more preferably less than 1 millisecond. The change should preferably result in an increase in the significance of the obtained spectrum. The generator can be configured to implement this change periodically or intermittently, if necessary.

[0025] The proposed system enables the surgical station to be connected to a cloud-based theragnostic data storage system (cloud). Optical characteristics are recorded at the surgical station using a light analyzer and transmitted to the cloud. Data analysis is performed in the cloud using an integrated self-learning system. This enables monitoring of the surgical station and surgeon's performance and, where possible, dynamically adapting it to the specific patient. Control of the surgical robot can also be fully or partially automated. Both central and local input and annotation systems can be used as data sources. The cloud-based theragnostic system includes a cloud-based data storage system with a machine-learning-based data processing unit.The data warehouse regularly receives optical emission spectra, bioimpedance data, and / or other electrical data for clinically relevant tissues with corresponding histopathological or other additional identification from local databases or directly from the surgical station. In addition, the optical emission spectroscopy (OES) cloud receives individual data, including electrical data, bioimpedance data, and optical emission spectra, from the operating rooms. During surgeries involving high-frequency surgery, the system continuously receives data from peripheral devices such as surgical cameras, robotic devices in the operating room, and tracking and visualization and / or diagnostic imaging systems such as ultrasound, optical coherence tomography, diffusion electrical tomography, impedance tomography, elastography, etc., either directly or through the operating room management system.Furthermore, the system can identify arrays of unreliable system data, particularly high-frequency surgery data, which is essential for reliable theragnostics. If unreliable system data is detected frequently or over a long period, an appropriate alarm can be triggered. Tissue recognition is continuously improved through continuous data input and its classification for diagnostics based on electrical and optical characteristics. This can be accomplished using machine learning algorithms. From the obtained electrical and optical characteristics, control parameters for robotic surgery can be derived and transmitted in real time to terminals.Furthermore, the data storage and processing device can maintain a library of electrical and optical characteristics, combined with tissue and patient characteristics, and suggest optimal generator settings (high-frequency settings) for ongoing surgical interventions. This enables the implementation of personalized medicine.

[0026] The theragnostic method proposed in the invention includes: receiving light emitted by a spark arising between an electrode of an electrosurgical instrument and biological tissue by a light receiving device; determining at least one optical characteristic from the received light by a light analyzer; generating an electric voltage by a generator that supplies the electrode of the electrosurgical instrument with electric current; determining at least one electrical characteristic by a detector device;determining a characteristic of the fabric (expressed, for example, in the form of a fabric mark) on the basis of at least one optical characteristic, wherein in the case of impossibility of reliably identifying the fabric only on the basis of at least one optical characteristic, the characteristic of the fabric is determined on the basis of only at least one electrical characteristic or on the basis of at least one electrical characteristic and at least one optical characteristic; and transmitting the characteristic of the fabric to the output device.

[0027] The details of the theragnostic system proposed in the invention are described in the following examples of implementing the invention using drawings, which show:

[0028] Fig. 1 is a schematic representation of a simple local theragnostic system,

[0029] Fig. 2 - image of the theragnostic system based on a cloud platform,

[0030] in Fig. 3 - spectrum for obtaining optical characteristics,

[0031] Fig. 4 - illustration of a set of data for determining the characteristics of the fabric,

[0032] Fig. 5 - theragnostic system with an improved generator,

[0033] in Fig. 6 - output pulses of the generator shown in Fig. 5.

[0034] Figure 1 shows a very schematic view, particularly with respect to data collection and processing, of a surgical station 10. The surgical station 10 includes operating room components not described below. In particular, it includes a surgical instrument 11 with an electrode 12 for acting on biological tissue 13 during a surgical intervention. The electrode 12 of the instrument 11 is powered by a generator 14 with an operating voltage u and an operating current i, which are supplied to the instrument 11 via a wire line. The operating voltage u and the operating current i are preferably high-frequency with a frequency exceeding 100 kHz, for example 300 or 400 kHz or any other suitable frequency. The operating voltage u and the operating current i are preferably selected in such a way that a spark 15 is formed on the electrode 12, interacting with the tissue 13 and providing the required surgical effect on the latter, such as coagulation, cutting, etc.

[0035] Generator 14 supplies operating voltage u and operating current i through detector device 16, which determines at least one electrical characteristic E. This electrical characteristic E may be operating current, operating voltage, frequency of operating voltage or operating current (in case of variable frequency of operating voltage), depth of operating voltage modulation, type of operating voltage modulation, duty cycle in case of pulse-width modulation of operating voltage or operating current, tissue impedance, nonlinearity of spark impedance, spark sensor reading obtained, for example, from measured DC component of real alternating voltage or combination of these parameters or parameter obtained from combination of one or more of these parameters. Electrical characteristic E may also include several such parameters. It is input into data storage and processing device 17.

[0036] The surgical station 10 also includes a light-receiving device 18, which is configured, in particular, to receive the light emitted by the spark 15. The light-receiving device 18 can be implemented as a part of the instrument 11 or separately from it. The light-receiving device 18 is connected to a light analyzer 19, which can be a part of the instrument 11 or, in an alternative embodiment, schematically shown in Fig. 1, can be connected to the light-receiving device 18 via a light guide 20. The light analyzer 19 is configured to determine one or more optical characteristics O from the received light of the spark.

[0037] An optical characteristic can be obtained by spectral analysis and / or spectral analysis of spark light. An optical characteristic can also be the spectrum itself, i.e., optical signals or data representing the spark light spectrum or a portion of this spectrum. An optical characteristic O can, for example, include several individual characteristics O1, O2, and O n , which are input into the data storage and processing device 17. Similarly, the electrical characteristic E may include several separate electrical characteristics E1, E2... E n . Individual optical characteristics O1, O2… O n may represent, for example, the intensities of individual waves of length λ1, λ2, … λ n , arising in the spectrum S of spark light. Individual optical characteristics O1, O2, O nmay be based on specific emission lines of characteristic chemical elements, such as the atomic emission lines of calcium, magnesium, zinc, or may be emission lines, emission bands, or spectral regions related to characteristic molecular fragments, such as CN, N2 + , CH, CC, NH, etc.

[0038] The data storage and processing device 17 comprises a large-capacity data storage 21 in which data obtained from one or more surgical stations 10 are stored in an organized manner. These data can be organized, for example, in the form of a table as shown in Fig. 4. This table shows the electrical characteristics E, as well as the optical characteristics O. They can relate to different patients P (P1, P2, P3... P n ) and different types of tissues T (T1, T2, T3… T n ). Patients P1-P nmay represent individual patients or specific groups of patients, organized by common characteristics such as age, weight, body fat percentage, disease status, etc. The table shown in Fig. 4 may contain other data not shown.

[0039] To create a data record in the storage 21 in accordance with the table shown in Fig. 4, the data storage and processing device 17 can be connected to the input device 22, by means of which the characteristics K (K1, K2… K n) diseases can be compared to patients or groups of patients, as well as to electrical characteristics E and optical characteristics O arising during surgical intervention on tissue 13. In addition, each data record can be assigned a label L indicating the presence of malignant tissue (m) or benign tissue (b). In Fig. 4, a data record (set) is understood as one row of the table shown. However, as already mentioned, the table may have even more columns and rows than shown and may contain significantly more data concerning, for example, the instruments and devices used, device settings, medical personnel, etc.

[0040] The data storage and processing device 17 may also be connected to the display device 23 and / or the acoustic device, which provides the surgeon with information about the tissue mark in contact with the spark 15. In addition, the data storage and processing device 17 may comprise an evaluation unit 24 or be connected to such a unit, which, in turn, is connected to the light analyzer 19 and receives from it either the optical characteristics O, or another signal, in any case determining the significance of the optical characteristics O. For example, the evaluation unit can determine the ratio of the signal level to the noise level, or the signal / noise ratio, between the background noise G and the individual optical characteristics O1, O2... O n If all or individual optical characteristics are from O1 to O n do not differ sufficiently from the main noise G, then the reliability of the optical characteristics O is noticeably reduced and may drop to zero.

[0041] The evaluation unit 24 supplies the data storage and processing device 17 with a corresponding signal, in the simplest case shown in Fig. 1, a “Yes” - “No” signal.

[0042] Instead of the signal-to-noise ratio, the evaluation unit can also generate a signal-to-signal ratio, which correlates two or more optical characteristics of the obtained spectrum. If this ratio falls below or exceeds a specified threshold, or is within a predetermined range, the spectrum is assessed as valid or invalid.

[0043] In a simple embodiment, evaluation unit 24 can also use only the intensity of one or more optical characteristics for quality assessment. The intensity can represent either the maximum value of an optical characteristic or the integral of the optical characteristic over a specific wavelength range. If the resulting value is above or below a predetermined limit or within a predetermined range, the spectrum is assessed as valid or invalid.

[0044] Evaluation unit 24 may also be configured to check for the presence of certain optical characteristics that allow a conclusion to be drawn about interaction with non-biological material. In particular, the optical characteristics of metals are applicable in this case to identify accidental interactions with other operating devices, such as metal clamps, and to evaluate such spectra as unreliable.

[0045] Furthermore, evaluation units 24 of other types may be used. For example, evaluation unit 24 may be configured to compare the obtained spectrum with multiple different spectra included in a reference set. This may be accomplished using reference matching, cross-correlation analysis, similarity analysis, or other methods. Evaluation unit 24 may be configured to mark the obtained spectrum as invalid if it does not correlate with or is not similar to any of the available reference spectra.

[0046] It is also possible to arbitrarily combine the individual evaluation blocks mentioned above in order to improve the quality of the latter.

[0047] For example, the surgical station 10 described above operates as follows.

[0048] First, the data storage and processing device 17 receives a message about a specific patient or about the patient’s belonging to one of the groups P1, P2… P n. This message can be transmitted as a result of recognizing an identifier attached to the patient in the form of a barcode, number, patient card, as well as as a result of manual entry of the patient's identification data, such as his name, via the input device 22. Let us assume, for example, that the patient belongs to the group P2 indicated in the table in Fig. 4. This means that for this patient, only those data sets are considered that are given for his patient group. After the start of the operation, both the electrical characteristics E and the optical characteristics O will be determined. In addition, the type of tissue to be treated can be entered, at least optionally, for example, lung tissue T1. This means that in the example shown in Fig. 4, only the first three data sets (the first three rows) are considered for further analysis. After that, the electrical characteristics E and the optical characteristics O are recorded and compared with the table shown in Fig.4 and typically containing significantly more lines and data sets than shown in the figure. Based on individual electrical characteristics from E1 to E. n and optical characteristics from O1 to O n It is now possible to determine with relative accuracy whether the tissue in contact with spark 15 should be labeled m for malignant tissue or label b for benign tissue. The corresponding information can then be output to display device 23.

[0049] In addition, additional boundary conditions such as diseases, from K1 to K, can be taken into account, especially for large arrays and data sets. n or other factors that may be included in the data records shown in Fig. 4.

[0050] It is possible to feed the system shown in Fig. 1 histological data on the tissue during surgery, thereby creating additional data sets, each of which establishes a relationship between the electrical characteristics E, the optical characteristics O, and the corresponding label L. This allows the system to acquire more and more data as it is used and make more accurate predictions.

[0051] Furthermore, thanks to the evaluation unit 24, the system is prevented from issuing incorrect assumptions based on uncertain optical characteristics O. If the reliability of the optical characteristics O decreases or is ultimately absent, then the system, that is, the data storage and processing device 17, can still independently issue, with some degree of reliability, a reliable label L (namely m or b) even based only on the electrical characteristics E in combination with other available characteristics.

[0052] The system 10 described above may also include, as shown in Fig. 2, several surgical stations 10 connected to a centralized portion of the data storage and processing device 17, called a cloud 26, via a remote connection 25 for transmitting data. The portion of the data storage and processing device 17 remaining in each surgical station 10 is formed by a local processor 27. In the illustrated embodiment of the invention, the local processor 27 also has an input device 28, through which data can be entered into the surgical station 10, for example, about the patient, the status of his disease, the results of a histological examination, etc. This information is transmitted, in whole or in part, by the processor 27 to the cloud 26. Similarly, the processor 27 transmits to the cloud 26, in whole or in part, the electrical and optical characteristics E and O.In cloud 26, the obtained patient characteristics, as well as the electrical and optical characteristics E, O, are examined on the basis of the data set shown in Fig. 4, and the corresponding label for indicating the benignity or malignancy of the tissue being treated is transmitted back to processor 27. The result can be communicated to the operator visually, acoustically or tactilely using display device 23.

[0053] One surgical station shown in Fig. 1, or surgical stations 10 shown in Fig. 2, form, in combination with cloud 26, a theragnostic system supporting both therapy and diagnosis.

[0054] In the surgical station 10 shown in Fig. 1 or Fig. 2, a feedback between the data storage and processing device 17 and the generator 14 may also be provided. For example, the electrical parameters of the generator 14, such as the power supplied by the instrument 11 to the tissue 13, the voltage, the current, the modulating signal shape, the voltage or current wave shape, or other electrical parameters may change depending on the measured electrical and / or optical characteristics E and / or O. This is provided, for example, to prevent an incorrect therapeutic effect or to improve diagnostic capabilities. For example, the system 10 may be configured to turn off the generator 14 upon detection of contact with malignant tissue or to switch to another, for example, higher, power level.The system 10 may also be configured to provide a permanent or temporary, as well as short-term, sporadic or repetitive change in the electrical parameters, thereby increasing the significance of the optical characteristics O. For example, in the first mode M1, in which the significance of the optical characteristics O is low, it is possible to switch - for a very short time, for example, for several milliseconds - to another mode M2, which ensures a higher significance of the optical characteristics O. This switching may be performed using a short-term change in voltage or modulation. The feedback 29 provided for this is effective, in particular, if the data set shown in Fig. 4 also contains a label K, which is correlated with the electrical characteristics E and the optical characteristics O and is an indicator of the reliability of the optical characteristics O.

[0055] Figure 5 shows the main components of generator 14 of the surgical station, designed to improve the quality of optical signals characterizing tissue. This generator 14, in turn, is designed to activate instrument 11, which, on the one hand, produces a surgical effect through a spark 15 affecting tissue 13, and on the other hand, generates light, which enters light analyzer 19 through light-receiving device 18 and light guide 20.

[0056] The peculiarity of the generator 14 shown in Fig. 5 is that it is configured to supply single pulses I1, I2, I3, I4, I5, I6…, which together form monopolar or bipolar high-frequency (HF) oscillations. For this purpose, the generator 14 is divided into a pulse generator 14a and a clock pulse sensor 14b, which supplies, on the one hand, a clock signal TS to the pulse generator 14a, which triggers each individual pulse from I1 to I6…. On the other hand, the clock pulse sensor 14b is configured to supply, on the other hand, a signal with an amplitude A to the pulse generator 14a, which determines the magnitude of each generated individual pulse from I1 to I6…. The pulse generator may include one or more inverters that can output an output pulse simultaneously or at different times and output a single output pulse upon receiving a clock signal.By simultaneously supplying multiple output pulses through multiple inverters, output pulses with a larger amplitude are generated because the output pulses from the individual inverters are summed.

[0057] The clock pulse sensor 14b is configured to supply a clock signal TS and a signal with amplitude A in such a way as to ensure the desired surgical effect. If, for example, it is necessary to generate a sequence of high-frequency pulses with a constant amplitude A, then the sequence of clock signals TS is supplied to the pulse generator 14a with a constant signal A. If, on the contrary, the current surgical mode requires an intermittent sequence of pulses with a constant amplitude, then the corresponding intermittent sequence of clock signals TS is supplied to the pulse generator 14a with a constant signal A.

[0058] The generator 14 shown in Fig. 5 is characterized by its connection to the light analyzer 19 and the evaluation unit 24. Both can operate according to any of the principles described above. However, the evaluation unit 24 is also connected to the operating mode catalog storage 30, which stores the operating mode data records (sets) characterizing the various pulse sequences I1...I6... related to the various therapeutic methods. In particular, the operating mode catalog storage 30 contains an identifier for each stored operating mode data record, which indicates the extent to which the corresponding pulse sequence is suitable for obtaining a spectrum suitable for use. In particular, the operating mode catalog storage stores the data for those pulse sequences I3 through I5 that produce meaningful spectra.For example, it may happen that the surgeon wants to select a therapeutic method that will result in the production of spectra of little significance. In the example shown, this is illustrated by a sequence of constant pulses I1, I2, etc. If the generation of such a pulse sequence and the resulting sparks 15 now result in the production of light whose spectrum, determined by the light analyzer 19, is classified by the evaluation unit 24 as insignificant, then a reliable optical analysis of the tissue using this pulse sequence cannot be performed. However, in the embodiment of the invention shown in Fig. 5, this results in the activation of the operating mode catalog store 30, which sends a corresponding signal to the clock pulse sensor 14b. This signal contains information either about a single pulse or about a short sequence of pulses I3, I4, I5, which result in the production of light whose spectrum is more suitable for use.The resulting pulse sequence is shown in Fig. 6. While the mode selected by the surgeon requires a sequence of constant high voltage pulses I1, I2, I6, etc. with a repetition frequency of, for example, 5 μs, the clock pulse sensor 14b is forced to introduce an intermediate sequence of Z pulses into the sequence of therapeutic effect signals I1, I2, I6 at repeating time intervals, for example, every 0.5 seconds.

[0059] The intermediate Z pulse sequence may include one or more pulses I3, I4, I5, which have the same or different amplitudes and are output at the same or different time intervals compared to pulses I1, I2, I6... I9 of the therapeutic signal. The number, time intervals, and amplitude of the intermediate pulses from I3 to I5 are preferably set in such a way as to obtain optimal significant spectra. The time duration of the intermediate Z pulse sequence is preferably set short enough that the surgical effect achieved by pulses I1, I2, and I6-I9... changes only slightly or not at all, much less worsens.

[0060] The therapeutic system proposed in the invention includes a surgical station 10 and a data storage and processing device 17, which contains in a suitable storage a large volume of data, in which patient data and therapeutic effect data are combined, for example, in the form of electrical and optical characteristics E, O. Electrical characteristics E are derived from electrical parameters of voltage and current, which are used to power the instrument 11. Optical characteristics are derived from light from a spark 15, which occurs when acting on tissue 13.

[0061] By combining electrical characteristics E and optical characteristics O into a single data set, such as a database containing other characteristics such as tissue characteristics and, optionally, patient characteristics, it is possible to automatically determine with high reliability whether an instrument is acting on healthy or diseased tissue. Prediction accuracy can be increased using machine learning by adding histological data to the data sets in addition to electrical characteristics E and optical characteristics O. In a preferred embodiment of the invention, this data is accumulated in a cloud 26 connected to multiple surgical stations 10. Thus, cloud 26 can receive data obtained at different surgical stations 10.

[0062] Reference Designations

[0063] 10 surgical station

[0064] 11 tool

[0065] 12 electrode

[0066] 13 biological tissue

[0067] 14 generator

[0068] 14a pulse generator

[0069] I1, I6… I9 therapeutic impulses

[0070] I3…I5 intermediate pulses

[0071] 14b Clock Sensor

[0072] TS clock signal

[0073] A signal with amplitude

[0074] u working voltage

[0075] i working current

[0076] 15 spark

[0077] E electrical characteristic

[0078] 16 detector device for electrical characteristic e

[0079] 17 data storage and processing device

[0080] 18 light-receiving device

[0081] 19 light analyzer

[0082] 20 light guide

[0083] Optical characteristics

[0084] P patient ID

[0085] T fabric identifier

[0086] 21 large-capacity data storage

[0087] 22 input device

[0088] 23 display device

[0089] 24 evaluation block

[0090] 25 Remote data connection

[0091] Cloud 26

[0092] 27 processor

[0093] 28 input device

[0094] 29 feedback

[0095] 30 Operating Mode Catalog Storage

[0096] Z intermediate pulse sequence.

Claims

1. Theragnostic system, including: • at least one surgical station (10) comprising at least: - a light-receiving device (18) for receiving light emitted by a spark (15) arising between an electrode (12) of an electrosurgical instrument (11) and biological tissue (13), - a light analyzer (19) configured to determine at least one optical characteristic (O) of the received light, - a generator (14) for generating electrical voltage (u) that supplies the electrode (12) of the electrosurgical instrument (11) with electrical current (i), - a detector device (16) for determining at least one electrical characteristic (E), - output device (23), and • a device (17) for storing and processing data, designed with the ability to: - determining the mark (L) of the fabric based on at least one optical characteristic (O), and if it is impossible to reliably identify the fabric only based on at least one optical characteristic (O) - determining the mark (L) of the fabric based only on at least one electrical characteristic (E) or based on at least one electrical characteristic (E) and at least one optical characteristic (O), and - transferring the fabric mark (L) for its output to the output device (23).

2. The system according to claim 1, characterized in that the light analyzer (19) contains a spectral analysis device designed with the possibility of determining, as an optical characteristic (O), a spectrum, parts of a spectrum, or parameters obtained from a spectrum or parts of a spectrum.

3. The system according to claim 2, characterized in that the light analyzer (19) or the data storage and processing device (17) contains a quality evaluation unit (24) for the spectrum, parts of the spectrum or parameters obtained from them, or is connected to the said quality evaluation unit (24).

4. The system according to claim 3, characterized in that the quality evaluation unit (24) is designed with the possibility of determining the signal-to-noise ratio of at least one spectral line (O1) or spectral range (O1, O2).

5. The system according to claim 3 or 4, characterized in that the quality evaluation unit (24) is configured to issue a quality criterion for the optical characteristic, and the device (17) for storing and processing data is configured to determine the mark (L) of the fabric based on the electrical characteristic (E) with a low degree of consideration or without consideration of the optical characteristic (O), if the quality criterion indicates low reliability or no reliability of the optical characteristic.

6. A system according to one of the preceding paragraphs, characterized in that it comprises an input device (22, 28) by means of which tissue identifiers (T) can be entered, wherein the input device (22, 28) is connected to a data storage and processing device (17) for transmitting a tissue identifier (T) to the latter.

7. A system according to one of the preceding paragraphs, characterized in that the device (17) for storing and processing data contains a set of data in which each set of optical and electrical characteristics (O, E) is associated with at least one tissue mark (L).

8. The system according to claim 6 or 7, characterized in that the identifier (T) of the fabric is determined on the basis of data entered via the input device (22, 28).

9. A system according to one of the preceding paragraphs, characterized in that the device (17) for storing and processing data is part of a surgical station (10).

10. A system according to one of the preceding claims, characterized in that the generator is controlled with respect to at least one operating parameter based on an optical characteristic (O).

11. A system according to one of the preceding paragraphs, characterized in that it is designed with the possibility of at least briefly switching the generator (14), operating in the first mode (M1), in which the optical characteristic (O) does not allow reliable identification of the tissue, to the second mode (M2), in which identification of the tissue is possible based on the optical characteristic.

12. The system according to one of the preceding paragraphs, characterized in that it includes several surgical stations (10).

13. The system according to claim 12, characterized in that the part (26) of the device (17) for storing and processing data is connected to the surgical station (10) via a data transmission device (25).

14. A system according to one of the preceding paragraphs, characterized in that the data storage and processing device (17) is connected to an input device (28) located outside the surgical station (10).

15. A method of theragnostics, including: - reception by the light-receiving device (18) of light emitted by a spark (15) arising between the electrode (12) of the electrosurgical instrument (11) and the biological tissue (13), - determination by the light analyzer (19) from the received light of at least one optical characteristic (O), - generation by the generator (14) of electric voltage (u), which supplies the electrode (12) of the electrosurgical instrument (11) with electric current (i), - determination by the detection device (16) of at least one electrical characteristic (E), - determining the characteristic (L) of the fabric based on at least one optical characteristic (O), wherein in the event that it is impossible to reliably identify the fabric only based on at least one optical characteristic (O), the characteristic (L) of the fabric is determined based only on at least one electrical characteristic (E) or based on at least one electrical characteristic (E) and at least one optical characteristic (O), and - transfer of the characteristic (L) of the fabric to the output device (23).

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