System for performing intraoperative functional mapping, user terminal, and use
The system enhances intraoperative functional mapping by integrating electrical and optical/acoustic stimulation with non-verbal data exchange, addressing communication errors and patient stress, ensuring efficient and safe neural function mapping.
Patent Information
- Application Number
- PCT/EP2025/055561
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-14
- Filing Date
- 2025-02-28
- Publication Date
- 2025-09-04
AI Technical Summary
Existing intraoperative functional mapping techniques face challenges such as verbal communication errors, patient stress, limited stimulation time, and sterility issues, particularly in cases where patients have motor restrictions or young children, leading to increased risk of seizures and prolonged operation times.
A system with a first stimulation unit for electrical brain stimulation, a second unit for optical and/or acoustic stimulation, a synchronization unit, a recording unit, an evaluation unit, and a communication network for non-verbal data exchange among team members, utilizing wireless terminals with graphical interfaces to streamline the process.
Facilitates quick, efficient, and reliable functional mapping with reduced patient stress and health risks, minimizing miscommunication and operation duration.
Smart Images

Figure EP2025055561_04092025_PF_FP_ABST
Abstract
Description
[0001] System for performing intraoperative functional mapping, user terminal and use
[0002] FIELD OF THE INVENTION
[0003] The invention relates to a system for performing intraoperative functional mapping of at least one neural function of a patient during a surgery on the patient. The present invention further relates to a user system and the use of one or more distributed terminals.
[0004] TECHNICAL BACKGROUND
[0005] In the case of brain tumors, the tumor is often removed surgically as completely as possible. Depending on the location of the tumor, there is a risk of damaging tissue that is essential for important functions such as movement and speech. To avoid this, a technique called speech mapping is used. Speech mapping helps a neurosurgeon identify eloquent areas. In speech mapping using direct electrical stimulation (DES), brain areas are electrically stimulated with a probe while the patient is awake and performing speech tests. If speech dysfunctions arise, the neurosurgeon knows that this brain area cannot be resected. There are well-known tests that can be used to test various language and cognitive functions or other neural functions of a patient during surgery.
[0006] For example, gliomas are among the most common malignant brain tumors for which neurosurgical removal of the tumor tissue is often the treatment of choice. A patient has the best chance of survival when the tumor is removed as completely as possible. However, the boundaries between healthy tissue and tumor tissue are often diffuse and not clearly visible, which presents neurosurgeons with a dilemma between oncological outcome and preserving functionality. Language, along with other sensory and motor skills, is one of the most important functions that should be preserved, since their loss severely restricts the patient's quality of life. The functional organization of the brain is very individual and can deviate significantly from general patterns, particularly in cases of massive structural changes such as those caused by a glioma.A mapping of the brain areas adjacent to the tumor as accurately as possible is therefore necessary for planning the surgical procedure and essential for a positive outcome.
[0007] An awake craniotomy can be performed on an affected patient, in which eloquent brain areas of the patient are localized using direct electrical stimulation (DES) in combination with language tests (tasks).
[0008] During a surgery, several people are involved in such functional mapping procedures. In addition to the patient, these people include clinically trained members of a surgical team, namely a neurosurgeon (NC) who performs the surgical procedure, a neurolinguist (NL) who interprets the functional tests, particularly the language tests, and a neurophysiologist (NP) who controls the stimulation.
[0009] Fig. 1 shows the conventional situation in an operating room with the people involved and the communication they have with each other. The neurosurgeon NC selects the point on the brain of patient P that is to be stimulated and passes this information on verbally to the neurophysiologist NP, the neurolinguist NL and the note-taker PR. The neurolinguist NL selects the corresponding task category and verbally communicates this to the neurosurgeon NC and the note-taker PR. Next, the neurosurgeon NC places the probe S and tells the neurophysiologist NP that he can start the electrical stimulation. If possible, the neurolinguist NL must present the task to patient P at the same time, since the stimulation can only last a maximum of four seconds.The neurolinguist NL then interprets the patient P's reaction R to the task presented to the patient P and verbally communicates the result to the neurosurgeon NC and the note taker PR.
[0010] Through verbal communication, depending on the characteristics of the operating room, the situation is such that everyone present has access to all the information exchanged. In some situations, however, it is useful for not everyone involved to receive all the information. Patient P may misinterpret the test results and thereby expose themselves to unnecessary stress, which is why it is necessary to keep them constantly informed about the progress of the operation and the next steps. Another critical fact is that the neurolinguist NL must objectively assess patient P's response. Knowing whether or not patient P is being electrically stimulated can influence the neurolinguist NL's interpretation and thus falsify the results of their assessment.
[0011] Verbal communication between participants also carries the risk that various messages are misunderstood or misinterpreted, leading to errors in the operational process. Especially in teams with members who have different native languages, purely verbal communication leads to difficulties in understanding each other among operational members.
[0012] Furthermore, the time span in which patient P can be electrically stimulated is extremely limited. The information that patient P can be shown the next task must be communicated to the neurolinguist NL within a few seconds. The neurolinguist NL has to present the tasks (e.g. display an image on a monitor) or otherwise stimulate a sensory organ of patient P, and patient P has to perceive the task presented to him and react to it. The longer this process takes, the higher the risk that the electrical stimulation will trigger an epileptic seizure in patient P, and the longer the language mapping takes overall, which is stressful for all participants and especially for patient P.
[0013] US 10 506 962 B2 describes a system and a method for carrying out intraoperative functional mapping of brain functions using a touch panel device that can be operated by the patient. The patient P reacts to a task presented to him by manually entering information into a touch panel device or tablet using a hand-held pen. This conventional system, however, assumes that the patient P can operate the tablet, which is not always the case. If, for example, a tumor has already led to a motor restriction in the patient P, the patient P can no longer enter information into the tablet. Even young children, as affected patients, are usually unable to use the tablet, particularly in the stressful situation of an operation.A further disadvantage of this conventional system is that the tablet has to be positioned precisely within arm's reach of the patient P so that the patient can operate it. Operating the tablet is also difficult for the patient P, particularly because the patient P's head is fixed during the operation. Furthermore, when positioning the patient's input tablet, care must be taken to ensure that the sterility of the operating conditions is maintained despite the provision of the tablet. This leads to a complex and lengthy set-up during preparation for the operation. In the system of US 10 506 962 B2, communication between the operating team and with the patient P is also verbal, with the associated disadvantages.
[0014] This is a situation that needs to be improved in order to achieve operational success.
[0015] SUMMARY OF THE INVENTION
[0016] It is therefore an object of the present invention to provide an improved system for performing intraoperative functional mapping on a patient, which in particular reduces the burden and health risks for a patient.
[0017] This object is achieved according to the invention by a system having the features of patent claim 1 and / or by a user terminal having the features of patent claim 25 and / or by a use having the features of patent claim 26. Accordingly, it is provided:
[0018] - A system for carrying out intraoperative functional mapping of at least one neuronal function of a patient during an operation on the patient: with a first stimulation unit for electrically stimulating a brain area of the patient at a stimulation site during the operation; with a second stimulation unit for providing at least one optical and / or acoustic stimulation for the patient during the electrical stimulation of the brain area of the patient by the first stimulation unit; with a synchronization unit for synchronizing the first stimulation unit and the second stimulation unit; with at least one recording unit for recording a response of the patient during the electrical stimulation of the brain area of the patient by the first stimulation unit and the stimulation of the patient by the second stimulation unit;with an evaluation unit for evaluating the patient's response recorded by the recording unit as to whether the electrically stimulated brain area of the patient is relevant for the exercise of a neuronal function; and with a communication and data transmission network for carrying out non-verbal communication between users of the various units of the system during the operation on the patient and for exchanging data between the units of the system.
[0019] - A user terminal, in particular a wireless tablet terminal, for a system according to the invention, with a graphical user interface for a user and with an interface to the communication and data transmission network of the system according to the invention.
[0020] - A use of a wireless tablet terminal for a system according to the invention.
[0021] An advantage of the system according to the invention for performing intraoperative functional mapping on a patient is that the functional mapping can be performed quickly, efficiently, and reliably with relatively little preparation time. Using such functional mapping according to the invention advantageously minimizes the stress and health risks for a patient.
[0022] Advantageous embodiments and further developments emerge from the further subclaims and from the description with reference to the figures of the drawing.
[0023] In one possible embodiment of the system, the first stimulation unit comprises a probe operable by a neurosurgeon for electrically stimulating a brain area of the patient at a stimulation site. This probe can be manually guided by the neurosurgeon. Alternatively, the probe can also be guided by a robotic arm operated by the neurosurgeon.
[0024] In a further possible embodiment of the system, the first stimulation unit applies an electrical stimulation signal with adjustable stimulation parameters for a specific stimulation duration to a stimulation site in the patient's brain area selected by a neurosurgeon.
[0025] In one possible embodiment of the system, the electrical stimulation of the patient's brain area carried out by the first stimulation unit is started via a user interface of a user device by a neurosurgeon or other user of a surgical team.
[0026] In a possible alternative embodiment of the system, the electrical stimulation of the patient's brain area performed by the first stimulation unit is automatically started in a preset waiting state only upon detection of tissue contact. This allows the necessary electrical stimulation time to be more precisely defined.
[0027] In one possible embodiment of the system, when the electrical stimulation of the patient's brain area starts, the first stimulation unit generates a trigger signal. This trigger signal is transmitted via the network or a cable from the first stimulation unit to the second stimulation unit, which automatically provides optical and / or acoustic stimulation for the patient upon receipt of the trigger signal. This frees the neurolinguist from having to present a task in a very short space of time or carry out any other optical and / or acoustic stimulation of the patient as soon as the neurosurgeon has begun the electrical stimulation. This eliminates a work step and frees the neurolinguist. The neurolinguist is therefore able to concentrate on assessing the patient's reaction. This improves the assessment results and thus the surgical outcome.In addition, the start of electrical stimulation no longer needs to be communicated verbally, thus reducing disturbances to other participants, especially the patient.
[0028] In one possible embodiment of the system, the second stimulation unit has a screen for displaying visual stimulation and / or a loudspeaker for delivering acoustic stimulation to the patient. Acoustic stimulation also makes it possible to stimulate patients whose visual functions have already been impaired by a brain tumor.
[0029] In one possible embodiment of the system, the second stimulation unit provides the patient with optical and / or acoustic stimulation selected by a neurolinguist via a user interface of a user device. This allows the neurolinguist to provide stimulation tailored to the specific patient and / or the specific neuronal function being examined and, if necessary, to adjust the optical or acoustic stimulation during the course of the operation, particularly with regard to the patient's observed reactions.
[0030] In one possible embodiment of the system, the recording unit has at least one microphone for recording an acoustic response of the patient during the electrical stimulation of the patient's brain area by the first stimulation unit and the simultaneous stimulation of the patient by the second stimulation unit. The microphone makes it possible to record the speech responses provided by the patient in a contactless manner, without the patient having to operate a tablet or the like, for example. In one possible embodiment of the system, the recording unit has at least one camera for recording a motor response of the patient during the electrical stimulation of the patient's brain area by the first stimulation unit and the simultaneous stimulation of the patient by the second stimulation unit.The use of cameras makes it possible to record the patient's motor responses without contact, for example, without the patient having to operate a tablet or the like. Recording the patient's P response using a microphone M and / or a camera K also offers the advantage that observation can be performed without contact, thus ensuring the sterility of the operating room.
[0031] In one possible embodiment of the system, the recording unit has at least one electrical electrode for recording a brain activity pattern of the patient during electrical stimulation of the patient's brain area by the first stimulation unit and simultaneous stimulation of the patient by the second stimulation unit. This offers the advantage that the patient does not have to consciously respond to a task presented to him, but can be passively subjected to electrical stimulation and simultaneous optical or acoustic stimulation. This relieves the patient and objectifies the measurement results with regard to the patient's reaction. The results of the various recording units, i.e. the microphones, cameras and recording electrodes, can be stored and sampled as synchronized signals.The recorded acoustic signal can be stored with the simultaneously recorded camera signal and the simultaneously recorded electrode signal as a data set for the patient's response for documentation purposes. Furthermore, the recorded data set can be evaluated in real time to assess the patient's response.
[0032] In one possible embodiment of the system, the evaluation unit has a user interface of a device which is intended to output the patient's response recorded by the recording unit during stimulation of the patient to a neurolinguist and to allow the neurolinguist to enter an evaluation of the patient's output. The evaluation unit can be integrated into a user terminal of the neurolinguist which has a corresponding graphical user interface. The user terminal has an interface for connection to the system's communications and data network. The user terminal is, for example, a portable tablet or the like.
[0033] In one possible embodiment of the system, the evaluation unit evaluates the patient's reactions recorded by the recording unit during the stimulation of the patient, at least partially automatically, for example by using artificial intelligence or corresponding evaluation algorithms.
[0034] In one possible embodiment of the system, the evaluation unit evaluates the patient's reaction patterns recorded by the recording unit using a trained artificial neural network to classify the patient's reaction. The acoustic signal, the camera signal and the electrode signal can be evaluated simultaneously to automatically evaluate or classify the reaction. For this purpose, data embedding can be carried out and the data fed into an input layer of a deep neural network (DNN). Alternatively, the audio data, the video data and the electrode data are evaluated separately by three separate, appropriately trained artificial neural networks of the system, which can be integrated into the evaluation unit of the system or connected to the system via a cloud connection.
[0035] In one possible embodiment of the system, a documentation device connected to the system's communication and data transmission network automatically documents the intraoperative functional mapping performed by the system on the patient. In one possible embodiment of the system, the documentation device is designed to document various types of information. This information includes the electrical stimulation performed by the first stimulation unit of the system at a stimulation site and the electrical stimulation signal applied by the first stimulation unit of the system to the stimulation site and / or its stimulation parameters as well as the position of the stimulation site.
[0036] The documented information preferably includes the optical and / or acoustic stimulations provided to the patient by the second stimulation unit during the electrical stimulation at the stimulation site. The documented information preferably also includes the patient's responses to the stimulations recorded by the recording units of the system. The documented information preferably also includes the assessment of the patient's responses to the stimulations recorded by the evaluation unit of the system. The documented information preferably also includes the communication transmitted via the communication and data transmission network of the system between users of the various units of the system during the operation on the patient and the data transmitted between the units of the system during the operation.
[0037] In one possible embodiment of the system, the system comprises a surgical microscope and / or a surgical camera which is directed at the stimulation site and delivers camera images of the stimulation site to a user interface of a user's portable terminal device.
[0038] In one possible embodiment of the system, the stimulation site displayed on the camera image via the user interface of the user's portable terminal can be marked and edited by an input from the user into the user interface of the portable terminal.
[0039] In one possible embodiment of the system, a position, an attitude and / or a spatial orientation of the probe of the first stimulation unit are determined and processed based on the camera images of the stimulation site (STS) of the surgical microscope and / or surgical camera.
[0040] In one possible embodiment of the system, a position, an orientation, and / or a spatial orientation of the probe or of another medical instrument is determined by a surgical neuronavigation system and transmitted to the system via a data interface. In one possible embodiment of the system, a plurality of visible spatial reference points, in particular reflective spheres or LEDs, are attached to the probe of the first stimulation unit and / or to another medical instrument hand-held by the neurosurgeon, which are optically detected by at least one camera of the surgical neuronavigation system.
[0041] In one possible embodiment of the system, the system is designed to perform an intraoperative speech mapping of at least one neural speech function of a patient during an operation on the patient.
[0042] In one possible embodiment of the system, the communication and data transmission network of the system comprises a wireless network, in particular a WLAN network, which connects portable terminals of users of the various units of the system during the operation on the patient, in particular users of a surgical team.
[0043] In one possible embodiment of the system, the probe of the first stimulation unit comprises a monopolar probe, a bipolar probe, or a probe that is switchable between monopolar stimulation and bipolar stimulation.
[0044] The above embodiments and developments can be combined with one another as desired, where appropriate. Further possible embodiments, developments, and implementations of the invention also include combinations of features of the invention described previously or below with respect to the exemplary embodiments that are not explicitly mentioned. In particular, the person skilled in the art will also add individual aspects as improvements or additions to the respective basic form of the present invention.
[0045] TABLE OF CONTENTS OF THE DRAWING
[0046] The present invention will be explained in more detail below with reference to the exemplary embodiments shown in the schematic figures of the drawings. In the drawings:
[0047] Fig. 1 shows a representation of a conventional surgical situation during the performance of intraoperative functional mapping on a patient;
[0048] Fig. 2 is a block diagram of a possible embodiment of a system according to the invention for performing intraoperative functional mapping in a patient;
[0049] Fig. 3 shows a representation of an operation situation during the implementation of an intraoperative functional mapping in a patient using the system according to the invention;
[0050] Fig. 4 is a flow chart illustrating the steps carried out in the system according to the invention;
[0051] Fig. 5A-5D show views of user interfaces of devices used by various participants in the system according to the invention during the performance of an intraoperative functional mapping; Fig. 6 shows a possible implementation of synchronization between synchronization units in a system according to the invention for performing an intraoperative functional mapping on a patient;
[0052] Fig. 7 is a schematic representation of a recording unit and an evaluation unit in the system according to the invention.
[0053] The accompanying drawings are intended to provide a further understanding of embodiments of the invention. They illustrate embodiments and, in conjunction with the description, serve to explain principles and concepts of the invention. Other embodiments and many of the noted advantages will be apparent upon reference to the drawings. The elements of the drawings are not necessarily shown to scale.
[0054] In the figures of the drawing, identical, functionally identical and acting elements, features and components are provided with the same reference symbols unless otherwise stated.
[0055] DESCRIPTION OF EMBODIMENTS
[0056] Fig. 2 schematically shows a possible embodiment of a system SYS according to the invention for performing an intraoperative functional mapping FM of at least one neuronal function of a patient P during an operation on the patient. The system SYS comprises a first stimulation unit 1 for electrically stimulating a brain area of the patient P at a stimulation site STS during the operation.
[0057] In one possible embodiment of the system SYS shown in Fig. 1, the first stimulation unit 1 has a probe 1A that can be operated by a neurosurgeon NC for electrically stimulating a brain area of the patient P at a selected stimulation site, as is also shown in Fig. 3. In one possible embodiment of the system SYS, the probe 1A of the first stimulation unit 1 that is operated by the neurosurgeon NC has a monopolar probe, a bipolar probe or a probe that can be switched between monopolar stimulation and bipolar stimulation.
[0058] The first stimulation unit 1 applies an electrical stimulation signal with adjustable stimulation parameters (e.g. amplitude, frequency, signal shape) for a specific stimulation duration STD to a stimulation site STS of the brain area of the patient P selected by a neurosurgeon NC via the probe 1A.
[0059] The system SYS further comprises a second stimulation unit 2 for providing at least one optical stimulation (e.g. displayed image) and / or acoustic stimulation to the patient P during the electrical stimulation of the brain area of the patient P by the first stimulation unit 1.
[0060] The system SYS shown in Fig. 2 further comprises a synchronization unit 3 which is provided for synchronizing the first stimulation unit 1 and the second stimulation unit 2. In the exemplary embodiment shown in Fig. 3, the probe 1A is connected via a cable 9 to the electrical stimulation unit 1, which, after the start of the stimulation, supplies via the cable 9 an appropriately set stimulation current for stimulating the patient P at the stimulation site STS for a stimulation duration STD. In the exemplary embodiment shown in Fig. 3, the electrical stimulation unit 1 and a synchronization unit 3 are integrated in a mobile assistance device 11 of a neurophysiologist NP, which assistance device is provided with a monitor 12.
[0061] In one possible embodiment of the system SYS, the electrical stimulation of the brain area of the patient P at the stimulation site STS, performed by the first stimulation unit 1, is started via a user interface of a user device by a neurosurgeon NC or other user of a surgical team. This can be done, for example, by the neurophysiologist NP by entering a command into a user interface 14 of the assistant device 11 shown in Fig. 3. Alternatively, the electrical stimulation can also be started by the neurosurgeon NC by entering a start command into a terminal device of the neurosurgeon NC.
[0062] In a further possible embodiment of the system SYS, the electrical stimulation of the brain area of the patient P carried out by the first stimulation unit 1 is automatically started in a set waiting state only when a tissue contact of the probe 1A of the first stimulation unit 1 with the organic tissue of the brain area at the stimulation site STS is detected.
[0063] In one possible embodiment of the system SYS, the synchronization unit 3 connected to the first stimulation unit 1 automatically generates a trigger signal TS when the electrical stimulation of the brain area of the patient P is started by the first stimulation unit 1, which trigger signal TS is transmitted via the signal shown in Fig.
[0064] 2 (dashed) and / or via a cable 10 (as shown in Fig. 6) from the synchronization unit 3 to the second stimulation unit 2 of the system SYS. The second stimulation unit 2 automatically provides optical and / or acoustic stimulation for the patient P upon receipt of the trigger signal TS. The trigger signal TS can be transmitted via a cable as shown in Fig.
[0065] 6, or transmitted via a data transmission network 6 of the system SYS. The trigger signal TS leads to synchronized stimulation by the two stimulation units 1, 2. In the embodiment shown in Fig. 3, the second stimulation unit 2 is integrated into a portable device or tablet 15 of the neurolinguist NL and supplies, for example, images as a task for the patient P.
[0066] In one possible embodiment of the system SYS, the second stimulation unit 2 has a screen for displaying optical stimulation and / or a loudspeaker for delivering acoustic stimulation to the patient P. The second stimulation unit 2 provides optical and / or selected acoustic stimulation for the patient P, selected by a neurolinguist NL via a user interface of the user device 15. The user device 15 is, for example, a portable tablet that can be operated by the neurolinguist NL, as shown in Fig. 3.
[0067] The system SYS shown in Fig. 2 contains at least one recording unit 4 for recording a reaction of the patient P during the electrical stimulation of the brain area of the patient P by the first stimulation unit 1 and the simultaneous stimulation of the patient P by the second stimulation unit 2. Fig. 7 schematically shows a possible embodiment of a recording unit 4 which supplies data to an evaluation unit 5.
[0068] In one possible embodiment, the recording unit 4 of the system SYS has at least one microphone M for recording an acoustic response of the patient P during the electrical stimulation of the brain area of the patient P by the first stimulation unit 1 and the simultaneous stimulation of the patient P by the second stimulation unit 2.
[0069] In a further possible embodiment of the system SYS, the recording unit 4 has at least one camera K for recording a motor reaction of the patient P during the electrical stimulation of the brain area of the patient P by the first stimulation unit 1 and the simultaneous stimulation of the patient P by the second stimulation unit 2.
[0070] In one possible embodiment of the system SYS, the recording unit 4 has at least one electrical recording electrode E for recording a brain activity pattern of the patient during the electrical stimulation of the brain area of the patient P by the first stimulation unit 1 and the simultaneous stimulation of the patient P by the second stimulation unit 2.
[0071] The system SYS also has an evaluation unit 5 , which is intended to evaluate the reaction R of the patient P recorded by the recording unit 4 . The evaluation is carried out as to whether or not the electrically stimulated brain area of the patient P is relevant for the exercise of a neuronal function under investigation.
[0072] In one possible embodiment of the system SYS, the evaluation unit 5 has a user interface of a user device for outputting the reactions R of the patient P recorded during the stimulation of the patient P by the at least one recording unit 4 of the system SYS to a neurolinguist NL and for the neurolinguist NL to input an evaluation B of the output reactions R of the patient P. In one possible embodiment, the evaluation unit 5 can be integrated into the terminal 15 of the neurolinguist NL.
[0073] In one possible embodiment of the system SYS, the evaluation unit 5 at least partially automatically evaluates the reactions R of the patient P recorded by the recording unit 4 during the stimulation of the patient P. This allows the evaluation to be objectified. In one possible embodiment of the system SYS, the evaluation unit 5 evaluates the reaction patterns R of the patient P recorded by the recording unit 4 using at least one trained artificial neural network integrated therein to classify the reaction of the patient P.
[0074] The system SYS shown in Fig. 2 comprises a communication and data transmission network 6 for carrying out non-verbal or electronic communication between users of the various units of the system SYS during the operation on the patient P and for exchanging data between the units 1, 2, 3, 4, 5 of the system SYS, which can be integrated in different devices. In one possible embodiment of the system SYS, the communication and data transmission network 6 of the system SYS has a wireless network, in particular a WLAN network, which connects portable terminals of users of the various units of the system SYS during the operation on the patient P, in particular users of a surgical team.
[0075] As shown in Fig. 2, in one possible embodiment of the SYS system, a documentation device 8 connected to the communication and data transmission network 6 of the SYS system automatically documents the intraoperative functional mapping performed by the SYS system on the patient P.
[0076] In one possible embodiment of the system SYS, the documentation device 8 is designed to document and store various types of information.
[0077] The information documented by the documentation device 8 includes in particular the electrical stimulation carried out by the first stimulation unit 1 of the system SYS at a stimulation site STS selected by the neurosurgeon NC and the electrical stimulation signal I (t ) applied by the first stimulation unit 1 of the system SYS to the stimulation site STS and / or its stimulation parameters as well as the position of the selected stimulation site STS .
[0078] The information documented by the documentation device 8 further comprises the optical and / or acoustic stimulations provided by the second stimulation unit 2 during the electrical stimulation at the stimulation site STS for the patient P, for example a task sequence presented to the patient P.
[0079] The information documented by the documentation device 8 further comprises the reactions R of the patient P to the stimulations recorded by the recording units 4 of the system SYS, i.e. microphone M, camera K, recording electrodes E.
[0080] The information documented by the documentation device 8 further includes the evaluation B of the patient P's responses R to the stimulations, recorded by the evaluation unit 5 of the system SYS. These may include input evaluations B of the neurolinguist NL and / or calculated evaluations B of an artificial intelligence module of the evaluation unit 5.
[0081] The information documented by the documentation device 8 further includes the communication transmitted via the communication and data transmission network 6 of the SYS system between users of the various units of the SYS system during the operation on the patient P and the data transmitted between the units and devices of the SYS system during the operation.
[0082] In one possible embodiment of the SYS system, the system also comprises a surgical microscope and / or a surgical camera, which is directed at the stimulation site STS for the probe 1A and delivers camera images of the stimulation site STS to a user interface of a user's portable terminal. In one possible embodiment of the SYS system, the STS stimulation site displayed on the camera image via the user interface of the user's portable terminal can be marked and edited by a user input into the user interface of the portable terminal.
[0083] In one possible embodiment of the system, a position, an orientation and / or a spatial orientation of the probe or another medical instrument is determined by a surgical neuronavigation system and transmitted to the system via a bidirectional data interface of the neuronavigation system.
[0084] In one possible embodiment of the system, several visible spatial reference points, in particular reflective spheres or LEDs, are attached to the probe of the first stimulation unit and / or to another medical instrument hand-held by the neurosurgeon, which are optically detected by at least one camera of the surgical neuronavigation system.
[0085] In a possible embodiment of the system SYS, the system is designed to carry out an intraoperative speech mapping of at least one neuronal speech function of a patient P during an operation on the patient.
[0086] The intraoperative process is lengthy and stressful for everyone involved. Synchronizing the electrical stimulation provided by the first stimulation unit 1 with the visual or acoustic stimulation of a sensory organ (eye, ear) of the patient P (for example, an image presented to the patient P or an acoustic stimulus for the patient P's ear) performed by the second stimulation unit 2 reduces the steps required to be performed by the surgical team during the operation and thus reduces the necessary operating time.
[0087] The synchronization of electrical stimulation with visual or acoustic stimulation can be achieved in one possible implementation by linking a neurostimulator to a PC via a cable, as shown in Fig. 6. In one possible implementation of the SYS system, the user can select image display software from several options. The integration of a complete speech mapping module can optimize other aspects of the process in addition to synchronization, such as the documentation of test results using the documentation device 8 shown in Fig. 2.
[0088] Alternatives to Direct Electrical Stimulation (DES), such as passive mapping using ECoG, can partially reduce the risks of mapping.
[0089] In the following, various aspects of language mapping using DES as an intraoperative method are explained and evaluated. Furthermore, a preferred technical setup is presented that improves the intraoperative mapping process by synchronizing stimulation and task playback.
[0090] The location of eloquent brain areas can vary considerably even in healthy individuals. In people with gliomas, the tumor grows and migrates, constantly altering the surrounding tissue. In slow-growing tumors, functional disturbances often persist for a long time because the brain responds with plasticity and reorganizes important functions. Furthermore, physical, chemical, and physiological causes can lead to deformation and movement of the brain tissue during surgery and during the opening of the skull.
[0091] Therefore , the anatomical knowledge of the neurosurgeon NC in combination with patient data of the patient P from imaging procedures is often not sufficient to differentiate tumor tissue from functional epicenters and to perform a resection of tissue without postoperative deficits .
[0092] Functional mapping offers the neurosurgeon NC the opportunity to verify preoperatively obtained data intraoperatively and to navigate the resection of tissue in such a way that areas are spared without the patient's sensory, motor or speech functions being lost.
[0093] Direct electrical stimulation (DES) can be used for this purpose. In motor mapping, electrical stimulation directly on the cortex causes the excitation of the brain area, resulting in muscle contractions of the corresponding body parts, which can be measured or seen by the surgical team or recorded by cameras K of the recording unit 4 of the SYS system. In speech mapping, on the other hand, electrical stimulation causes a temporary lesion of the specific brain area of the patient P. To observe the impairments in functionality, the patient P must be awakened and perform speech tests while being electrically stimulated.
[0094] If the electrically stimulated brain area of patient P is essential for their speech functions, the patient P will not be able to perform the speech tests correctly. The information regarding whether speech functions are impaired, and if so, which ones, guides the neurosurgeon during tissue resection. In addition to the intraoperative benefit, the data from speech mapping with direct electrical stimulation (DES) can also provide valuable insights into the study of fundamental language processing.
[0095] When brain areas essential for language are damaged or missing, this manifests as various language deficits. In addition to complete speech loss ("speech arrest"), dysfunctions such as anomia (speech is possible, but objects cannot be named), dysarthria (unintelligible speech), or paraphasia (words are replaced by semantically or phonologically related words) can also occur.
[0096] During speech processing, auditory and visual input are integrated at phonological, syntactic, and semantic levels, requiring complex cognitive processes. Speech mapping is based on neurolinguistic tests that must cover all functions necessary for speech and are designed to identify these as clearly as possible using language dysfunctions. This clearly demonstrates that the selection of tests also has a decisive influence on the outcome. Surgical teams can use their own test batteries, as there is no generally accepted standard.
[0097] The stimuli presented to patient P by the second stimulation unit 2 of the SYS system are, depending on the test, auditory (spoken words or sentences) or visual (written words or sentences, black and white drawings) or a combination of both. Auditory stimuli can be output to patient P via loudspeakers on the second stimulation unit 2 of the SYS system. In one possible implementation, these loudspeakers are located in a headset worn by patient P. Furthermore, the neurolinguist NL can listen to the auditory stimulus and patient P's acoustic response to the acoustic stimulus via headphones in order to assess the response. This means that the members of the surgical team are not acoustically disturbed.
[0098] If a patient P is diagnosed with a brain tumor (D-HT), the location, size and type of brain tumor HT are determined using various imaging techniques such as MRI, PET, CT scans or EEG / MEG data. This structural mapping is necessary to plan the next steps. If it is determined that functional areas, particularly the language areas, could be affected, functional mapping must follow. This mapping includes critical stimulation points KSS, which are obtained through preoperative testing PT, as shown in Fig. 4. For functional mapping, methods such as fMRI, nTMS, ECoG or EEG / MEG can be used. In these procedures, tests are carried out on the patient P while data on brain activity is collected.
[0099] In functional magnetic resonance imaging (fMRI), active areas are marked based on the blood oxygen level (BOLD value) on high-resolution anatomical scans. Navigated transcranial magnetic stimulation (nTMS) uses previously taken images of the brain and the principle of magnetic induction to specifically stimulate brain areas and then infer function based on their response. Time-dependent data such as ECoG and EEG / MEG, which are recorded during language tests, can also provide information about the location of functional regions. Based on the data obtained, a map of the functional areas is created preoperatively. The tests used to create this map can be based on specialist literature and are often based on the experience of the respective surgical team. Standardized test batteries such as those in DuLIP or BNT can be used (test set in Fig.).
[0100] As shown in Fig. 4, preoperative planning involves verifying the theoretical functional map using specific tests, which are then used to evaluate and adapt the test battery to patient P. The result of preoperative planning is, on the one hand, a list of critical areas that must be tested for functionality intraoperatively using DES. On the other hand, a test set of functional tests tailored to patient P is obtained, particularly language tests, which are repeated intraoperatively.
[0101] Awake surgery on a patient P places high demands on the surgical team. The anesthesiologist, for example, must balance the patient P at the right point between analgesia and anesthesia, while a speech therapist, often in conjunction with a neuropsychologist, guides the patient P through functional tests, particularly speech tests, interprets the results, and communicates them. The neurosurgeon NC must immediately implement the results of the functional tests, particularly speech tests, and perform the delicate tissue resection.
[0102] The situation is extremely stressful for patient P, and situations in which speech deficits occur are particularly frightening and, in addition to position-related physical discomfort, lead to psychological stress. There is a constant exchange of information between the members of the surgical team, and the interaction with patient P has a fundamental influence on the outcome of the operation. With the system SYS according to the invention, the patient P is relieved of stress in that communication between the members of the surgical team is largely non-verbal, via the communication network 6, and thus cannot be followed by patient P. Patient P can therefore concentrate better on the tasks assigned to him and is not distracted or confused by verbal communication between the members of the surgical team.
[0103] The operating room and its technical equipment can facilitate the work of the surgical team and contribute to the success of the operation. In addition to instruments for head fixation, neuronavigation and imaging techniques are used to implement surgical approaches. These can sometimes be combined with a surgical microscope. Functional mapping itself requires a stimulator for cortical stimulation. A mapping suction device—i.e., a suction device with integrated stimulation function—can be used subcortically.
[0104] To monitor the effects of the stimulation on patient P, one possible embodiment allows brain activity to be monitored via ECoG. Furthermore, muscle reactions can be detected using EMG measurements by a recording unit 4 of the SYS system.
[0105] Documenting the results of functional tests, particularly language tests, is also an important factor. A common but cumbersome method for the NC neurosurgeon is to mark the stimulated brain areas with small, numbered pieces of paper. The test results are then tabulated or documented using a color-coded grid superimposed over an intraoperative photograph or stencil. Sophisticated systems use 3D MRI models of the brain to visualize and document the stimulation results or automatic video tagging, which registers the tip of the electrode and documents the duration of stimulation. To enable postoperative review of the surgical procedure, the SYS system can be equipped with video recording devices that capture or record all components of the operation.This includes an operating microscope, a navigation system, video and audio recordings of the patient and the entire operating room.
[0106] Direct electrical stimulation (DES) can be used for intraoperative speech mapping. It involves applying an electrical current I(t) directly to the patient's cortex to localize functional regions. However, stimulation carries the risk of inducing epileptic seizures. To minimize this risk, it is important to observe the following stimulation parameters. Electrical stimulation can be performed using a bipolar probe, where the electrical field is limited to an area between the two poles, or a monopolar probe, which allows stimulation over a larger radius.
[0107] The use of low frequencies (50 - 60 Hz) has become widely established with a current strength I in the range 1.5 mA to a maximum of 20 mA. In order to be able to localize cognitive functions or speech, while at the same time keeping the risk of epileptic seizures low, a stimulation duration of three to four seconds is recommended and successive stimulation of the same site should be avoided. Temporary inability of the patient P to react due to epileptic seizures can be ruled out by alternating tests with and without stimulation and by having the patient P speak as continuously as possible. In the case of potential implementation, a site is rated as negative if it has been tested at least three times and the patient P's response was free of speech errors each time.In one possible embodiment of the SYS system, high-frequency electrical stimulation can be used for functional mapping, particularly for motor mapping or speech mapping, since the associated significantly shorter stimulation duration (e.g., 250 Hz for 10 to 20 ms) greatly reduces the risk of induced epileptic seizures in patient P. The timing of stimulation and speech task must be very precise. Observation of patient P is preferably supplemented by objective measurement data (e.g., EMG).
[0108] The flowchart in Fig. 4 shows the preoperative and intraoperative process of functional mapping, particularly speech mapping. Fig. 4 summarizes the preoperative (P-OP) and intraoperative (I-OP) process of speech mapping. The preoperative process (P-OP) is already described above. With information about critical stimulation sites (KSS) and a patient-specific test battery, intraoperative speech mapping can begin.
[0109] The stimulation parameters, such as frequency and amplitude, are selected in step S1 according to the guidelines described above and specially adapted for the patient P. On the basis of the stimulation site chosen by the neurosurgeon NC in step S2, the neurolinguist NL selects a corresponding task in step S3. As soon as the probe has been correctly placed in step S4, the neurophysiologist can switch on the electrical stimulation in step S5, whereupon a task is displayed to the patient P as quickly as possible in step S6. The reaction R of the patient P observed and recorded in step S7 is interpreted by the neurolinguist NL, possibly in collaboration with a psychologist, in step S8. The positive or negative evaluation result B is communicated electronically by the neurolinguist NL to the neurosurgeon NC via the communication network 6 in step S9 and documented together with the other properties of the run in step S10.At the cortical level, the next stimulation site (STS) is then used. In the subcortical context, depending on the evaluation result in the Sil step, the brain is resected before stimulation is initiated again. The procedure depicted in Fig. 4 may vary depending on the personnel, equipment, and clinical setting.
[0110] As shown in Figs. 5A-5D, the various members of the surgical team each have terminals with a graphical user interface (GUI) that is designed for the respective work steps to be carried out by the respective surgical team member.
[0111] Fig. 5A shows an example of a graphical user interface GUI of a neurophysiologist NP.
[0112] Fig. 5B shows an example of a graphical user interface GUI of a patient P. Fig. 5C shows an example of a graphical user interface GUI of a neurolinguist NL.
[0113] Fig. 5D shows an example of a graphical user interface GUI of a neurosurgeon NC.
[0114] In a preferred embodiment, the system SYS has a movable monitor that can be adjusted to the position of the patient P. The monitor can display images as a task, for example, a car, as shown in Fig. 5B. In one possible embodiment, the system SYS can output auditory stimuli or instructions to the patient P via loudspeakers.
[0115] The system SYS preferably has a portable screen / tablet 15 for the neurolinguist NL. The system SYS provides the neurolinguist NL with an interface for selecting and switching between different tasks. The neurolinguist NL can create individual task sequences preoperatively using his GUI. The task sequences can be exported and imported. The neurolinguist NL can select tasks and present the selected tasks to the patient P intraoperatively. The neurolinguist NL can view the information that is important to him at any time. This includes the display of the current task and the display of the current stimulation site STS. The neurolinguist NL can select the task and register the assessment results B using the GUI of his device 15. In one possible embodiment, the neurolinguist NL can synchronize the task display with the electrical stimulation.The neurolinguist NL can also display tasks without stimulation. Electrical stimulation preferably triggers the task display. Tasks can also be displayed manually, e.g., by the neurolinguist NL pressing a button or other control element on the monitor.
[0116] The neurosurgeon NC has the option of viewing the stimulation status via the GUI shown in Fig. 5D. The system SYS can visually report the start and stop of stimulation to the neurosurgeon NC. In one possible embodiment, the neurosurgeon NC can control the stimulation from the sterile field. A switch / button on the probe 1A can be provided for the neurosurgeon NC to control the electrical stimulation. In one possible embodiment, the neurosurgeon NC can switch between monopolar and bipolar stimulation. A switch or foot switch enables the switchover. The neurosurgeon NC can view the information that is important to him at any time. The system SYS can display the information under a microscope or on a screen. This includes displaying the stimulation parameters, displaying patient P, and displaying the current task.
[0117] The neurophysiologist NP can also view the information that is important to him at any time using the GUI shown in Fig. 5A. This includes the display on the ISIS system monitor, the display of the usual neuromonitoring measurement views, the display of the current task and the display of the patient video. A start / stop control element can be provided for manually starting / stopping the electrical stimulation. The electrical stimulation is preferably synchronized with the presentation of the task for the patient P. The neurophysiologist (or monitor) NP can enter the location of the stimulation point. The neurosurgeon NC, the neurolinguist NL and the neurophysiologist NP have the option of evaluating all data postoperatively. Documentation is preferably synchronized. The data can be exported.
[0118] The neurophysiologist NP and / or the neurolinguist NL can ergonomically record the assessment results B of the functional tests, in particular the language tests. Stimulation sites STS can be created and named preoperatively. Possible response options or results in a possible implementation include “positive”, “negative” and “uncertain”. The assessment results can also be coded with traffic light colors. For example, three tests can be run for each stimulation site STS, each with a corresponding assessment B. If three out of three (3 / 3) assessments B are positive, the overall result is positive (green); if zero out of three (0 / 3) assessments B are positive, the overall result is negative (red); otherwise the overall result is uncertain (yellow).
[0119] As shown in Figures 5A, 5C, and 5D, the GUIs of the neurophysiologist (NP), the neurolinguist (NL), and the neurosurgeon (NC) preferably each have a progress bar indicating the duration of the electrical stimulation or test. In one possible implementation, the timer only starts running after probe 1A makes contact with the organic tissue. The neurosurgeon (NC) and the neurolinguist (NL) can hear and see the patient (P) during the operation.
[0120] The flow chart shown in Fig. 4 illustrates the complexity of intraoperative speech mapping and the involvement of several people. One way to make speech mapping more efficient is to technically synchronize electrical stimulation and image display. If the image is displayed immediately at the start of electrical stimulation, valuable time can be saved, both in terms of stimulation time and the entire mapping procedure. In addition, automation frees the neurolinguist (NL) from the task of presenting the task to patient P, allowing them to concentrate on observing patient P. The technical coordination of electrical stimulation and task presentation reduces the number of steps required by the surgical team, facilitates the intraoperative process, and can save resources.
[0121] Fig. 3 shows the situation during speech mapping with technical synchronization of stimulation and task playback in the inventive system SYS. The neurolinguist NL no longer needs to be informed when the electrical stimulation is activated, since the system SYS automatically triggers the task display. Furthermore, by integrating a documentation function for results into the stimulation program, the neurophysiologist NP can take over the tasks of the note-taker PR shown in Fig. 1.
[0122] One possible variant for synchronizing stimulation and task playback is to connect the stimulator to a personal computer, on whose monitor the tasks are displayed. One possible embodiment uses a cable that connects the ISIS neurostimulator to the computer via an interface, as shown in Fig.
[0123] 6 . The structure of this variant is shown schematically in Fig. 6 and includes several components. A device is used to control the neurostimulator. The neurostimulator can be connected to the device together with an EMG headbox. With each stimulation, the neurostimulator sends a trigger signal TS via the trigger output, which is connected to the device 15 for the task display via the special connecting cable 10.
[0124] Another possible solution does not require external software, but relies on the integration of a complete language mapping module. This module controls the stimulation, plays back the tasks on an additional screen, and documents the results.
[0125] An important feature of the language mapping module is a user-friendly way to document test results intraoperatively using the SYS system's documentation device 8. Traditionally, documentation is often done in tabular form, which is error-prone and confusing.
[0126] In one possible embodiment, a user has the option of uploading an image, e.g. a screenshot from the surgical microscope, and clicking on it to create points that represent points stimulated with the probe. Only a fixed maximum number of runs can be entered per point. A point is marked as positive if all tests were positive. A point is marked as negative if all tests were negative. Otherwise the point is marked as uncertain. Another possible solution involves the integration of navigation software and result documentation, which makes it possible to avoid duplicating the effort required to localize points. A combined system can therefore automatically record the exact point of the probe via the connected navigation system and feed it in and display it on the neurolinguist's tablet.
[0127] Although direct electrical stimulation (DES) is widely used, some disadvantages of this method are known. There is a risk that the stimulation will trigger epileptic seizures. The procedure is also relatively time-consuming and places great demands on the large surgical team. Interaction with the patient P is necessary and puts them under additional stress. With some patient groups, e.g. children, such interaction is hardly possible. The evaluation of the tests is based on the qualitative interpretation of the patient response R and is subject to the subjective perception of the neurolinguist NL.
[0128] An alternative to DES is mapping using ECoG. The ECoG is used intraoperatively to monitor epileptic seizures or so-called after-discharges. The electrode array placed on the cortex can also be used for passive speech mapping. This involves measuring brain activity using a grid electrode while the patient P solves language tasks or passively listens to a text, for example, which does not require active interaction. The activity patterns are evaluated by computer and in real time. The evaluation is therefore less subjective and the mapping is completed in just a few minutes. The algorithm for identifying language areas is based on the evaluation of increased gamma activity. A main goal of intraoperative functional mapping, particularly speech mapping, is to achieve the best possible surgical outcome for the patient P.The proportion of tumor tissue removed correlates with the life span gained. If essential functions such as movement and speech are damaged too severely by the resection, this limits the patient's quality of life. Finding the right balance is often a balancing act for the medical team and can only be made possible by methods such as speech mapping. The procedure is complicated and requires a lot of experience and routine from the surgical team to ensure an optimal result. Standardized protocols and functional tests as well as corresponding detailed and largely automated documentation help even less experienced surgical teams to access the mapping techniques and make the results comparable for research. The equipment in the operating room also plays a significant role.
[0129] In the SYS according to the invention, work steps and personnel resources can be saved through the technical synchronization of stimulation processes, in particular electrical stimulation and audio / visual stimulation.
[0130] Although the present invention has been fully described above with reference to preferred embodiments , it is not limited thereto but can be modified in many different ways .
[0131] The embodiments of the system SYS according to the invention shown in Figures 2-7 are exemplary. However, other embodiments are also possible and sometimes advantageous. For example, in an alternative embodiment, not all members of the surgical team are located in the operating room. For example, the neurolinguist NL can be connected to the local network of the system SYS via a gateway and perform assessments B from another location.
[0132] In one possible embodiment, the SYS system can also use AR and VR devices for the surgical team members NC, NL, NP, and the patient P. In one possible implementation, the patient P wears glasses through which visual stimuli or tasks are displayed. These visual stimuli can also include 3D images as a task.
[0133] In one possible embodiment, the resection of tissue can be carried out by a surgical robot of the SYS system, which is controlled and monitored by the new surgeon NC via a user interface. A preoperatively created 3D data model of the brain of the patient P with critical stimulation points KSS and their spatial coordinates (x, y, z) can provide data for a controller of the robot, which is provided for controlling a first robot arm of the robot, which guides a probe 1A for electrical stimulation, and for controlling a second robot arm of the robot, which guides a tool for removing tissue.
Claims
PATENT CLAIMS 1. System (SYS) for carrying out intraoperative functional mapping of at least one neuronal function of a patient during an operation on the patient (P), comprising a first stimulation unit (1) for electrically stimulating a brain area of the patient (P) at a stimulation site (STS) during the operation; a second stimulation unit (2) for providing at least one optical and / or acoustic stimulation for the patient (P) during the electrical stimulation of the brain area of the patient (P) by the first stimulation unit (1); a synchronization unit (3) for synchronizing the first stimulation unit (1) and the second stimulation unit (2);with at least one recording unit (4) for recording a reaction of the patient (P) during the electrical stimulation of the brain area of the patient (P) by the first stimulation unit (1) and the stimulation of the patient (P) by the second stimulation unit (2); with an evaluation unit (5) for evaluating the reaction of the patient (P) recorded by the recording unit (4) as to whether the electrically stimulated brain area of the patient (P) is relevant for the exercise of a neuronal function; and; with a communication and data transmission network (6) for carrying out non-verbal communication between users of the various units of the system during the operation on the patient (P) and for exchanging data between the units of the system.
2. System according to claim 1, characterized in that the first stimulation unit (1) has a probe (1A) operable by a neurosurgeon (NC) for electrically stimulating a brain area of the patient (P) at a stimulation site (STS).
3. System according to one of the preceding claims, characterized in that the first stimulation unit (1) is designed to apply an electrical stimulation signal with adjustable stimulation parameters for a specific stimulation duration to a stimulation site (STS) of the brain area of the patient (P) selected by a neurosurgeon (NC).
4. System according to one of the preceding claims, characterized in that a user interface of a user device is provided which is designed to start the electrical stimulation of the brain area of the patient (P) carried out by the first stimulation unit (1) via a user interface by a neurosurgeon (NC) or another user of a surgical team and / or to start it automatically in a set waiting state upon a detected tissue contact.
5. System according to claim 4 characterized in that the first stimulation unit (1) is designed to generate a trigger signal (TS) when the electrical stimulation of the brain area of the patient (P) starts, which trigger signal is transmitted via the network (6) or via a cable from the first stimulation unit (1) to the second stimulation unit (2), which automatically provides optical and / or acoustic stimulation for the patient (P) after receiving the trigger signal (TS).
6. System according to one of the preceding claims, characterized in that the second stimulation unit (2) has a screen for displaying an optical stimulation and / or a loudspeaker for delivering an acoustic stimulation to the patient (P).
7. System according to claim 6, characterized in that the second stimulation unit (2) is designed to provide an optical and / or selected acoustic stimulation for the patient (P) selected by a neurolinguist (NL) via a user interface of a user device.
8. System according to one of the preceding claims, characterized in that the recording unit (4) has at least one microphone (M) which is designed to record an acoustic reaction of the patient (P) during the electrical stimulation of the brain area of the patient (P) by the first stimulation unit (1) and the simultaneous stimulation of the patient (P) by the second stimulation unit (2).
9. System according to one of the preceding claims, characterized in that the recording unit (4) has at least one camera (K) which is designed to record a motor reaction of the patient (P) during the electrical stimulation of the brain area of the patient (P) by the first stimulation unit (1) and the simultaneous stimulation of the patient (P) by the second stimulation unit (2).
10. System according to one of the preceding claims, characterized in that the recording unit (4) has at least one electrical electrode (E) which is designed to record a brain activity pattern of the patient (P) during the electrical stimulation of the brain area of the patient (P) by the first stimulation unit (1) and / or the simultaneous stimulation of the patient (P) by the second stimulation unit (2).
11. System according to one of the preceding claims, characterized in that the evaluation unit (5) has a user interface which is designed to output reactions of the patient (P) recorded by the recording unit (4) during the stimulation of the patient (P) to a neurolinguist (NL) and to input an evaluation of the output reactions of the patient (P) by the neurolinguist (NL).
12. System according to one of the preceding claims, characterized in that that the evaluation unit (5) is designed to at least partially automatically evaluate the reactions of the patient (P) recorded by the recording unit (4) during the stimulation of the patient (P).
13. System according to claim 12, characterized in that the evaluation unit (5) is designed to evaluate the reaction patterns of the patient (P) recorded by the recording unit (4) by means of a trained artificial neural network for classifying the reaction of the patient (P).
14. System according to one of the preceding claims, characterized in that a documentation device (8) connected to the communication and data transmission network (6) of the system is provided, which is designed to automatically document the intraoperative functional mapping carried out by the system on the patient (P).
15. System according to claim 14, characterized in that the documentation device (8) is designed to document at least one of the following information: - the electrical stimulation carried out by the first stimulation unit (1) of the system at a stimulation site (STS) and the electrical stimulation signal applied by the first stimulation unit (1) of the system to the stimulation site and / or its stimulation parameters as well as the position of the stimulation site (STS), - the optical and / or acoustic stimulations provided by the second stimulation unit (2) during the electrical stimulation at the stimulation site (STS) for the patient (P), - the patient's (P) responses to the stimulations recorded by the recording units (4) of the system (1), - the evaluation of the patient's (P) responses to the stimulations recorded by the evaluation unit (5) of the system; and - the communication transmitted via the communication and data transmission network (6) of the system between users of the various units of the system during the operation on the patient (P) and the data transmitted between the units of the system during the operation.
16. System according to one of the preceding claims, characterized in that at least one surgical microscope and / or one surgical camera is provided, which is directed towards the stimulation site (STS) and which is designed to deliver camera images of the stimulation site (STS) to a user interface of a user's terminal device.
17. System according to claim 16, characterized in that the stimulation point (STS) displayed on the camera image via the user interface of the user's terminal device can be marked and edited by the user entering information into the user interface of the portable device.
18. System according to claim 16, characterized in that a position, a location and / or a spatial orientation of the probe (1A) of the first stimulation unit (1) and / or of another medical instrument hand-held by the neurosurgeon (NC) are determined and processed based on the camera images of the stimulation site (STS) of the surgical microscope and / or the surgical camera.
19. System according to one of the preceding claims 2 to 18, characterized in that a position, a location and / or a spatial orientation of the probe (1A) of the first stimulation unit (1) and / or of another medical instrument hand-held by the neurosurgeon (NC) is determined by a surgical neuronavigation system and can be transmitted to the system via a bidirectional data interface.
20. System according to claim 19, characterized in that several visible spatial reference points, in particular reflective spheres or LEDs, are attached to the probe (1A) of the first stimulation unit (1) and / or to the other medical instrument hand-held by the neurosurgeon (NC), which are optically detected by at least one camera of the surgical neuronavigation system.
21. System according to one of the preceding claims characterized in that the system is designed to carry out an intraoperative speech mapping of at least one neuronal speech function of a patient during an operation on the patient (P).
22. System according to one of the preceding claims, characterized in that the communication and data transmission network (6) of the system comprises a wireless communication network, in particular a WLAN network, which communicatively connects portable terminals of users of the various units of the system during the operation on the patient (P), in particular users of a surgical team.
23. System according to one of the preceding claims, characterized in that the probe (1A) of the first stimulation unit (1) comprises a monopolar probe, a bipolar probe and / or a probe which is switchable between monopolar stimulation and bipolar stimulation.
24. System according to one of the preceding claims, characterized in that a surgical robot is provided which can be controlled by a neurosurgeon via a user interface.
25. User terminal, in particular a wireless tablet terminal, for a system (SYS) according to one of claims 1 to 21, with a graphical user interface for a user and with an interface to the communication and data transmission network (6) of the system (SYS).
26. Use of a wireless tablet terminal for a system according to one of claims 1 to 24.
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