Method for controlling a surgical RF generator

Abstract

Method for controlling a surgical RF generator to deliver high-frequency current to at least one output of the RF generator, comprising the steps (a) Reading the activation of an interval detection, (b) Detection of an interval actuation of a switching device, (c) Creating a retrievable output profile from the detected interval actuation, (d) Signaling that the created output profile is available for output to the at least one output of the RF generator, (e) Reading an actuation of the switching device to trigger the output of the created output profile, and (f) Output of the created output profile to at least one output of the RF generator.

Description

Technical area

[0001] The invention relates to a method for controlling a surgical RF generator according to claim 1 and to a surgical RF generator according to claim 11. State of the art

[0002] Surgical devices powered by high-frequency current are known in the art. One or more instruments, such as electrodes, are connected to a surgical device comprising an HF (high-frequency) generator that delivers high-frequency electrical current. These instruments allow a surgeon to specifically damage or cut body tissue. For example, in diathermy, tissue structures are severed, with the affected vessels being closed simultaneously with the cutting. The surgical device can control other associated devices, such as suction or irrigation.

[0003] Such devices can be specifically adjusted to the surgical procedure to be performed (for example, for a procedure in general surgery, visceral surgery, urological surgery, or cardiac surgery) and can also be personalized with regard to the surgeon. EP 1 337 194 B1 describes a method for operating an instrument for HF surgery, wherein operating data of the device, e.g., an HF generator, is recorded at least during a first use of the instrument connected to the device, sent to a storage device connected to the instrument, and stored. Upon reuse or inspection of the instrument, these operating data are sent to a data acquisition device, and the device is adjusted according to the operating data recorded during the first use such that the instrument can be operated as it did during the first use.WO 2015 / 036444 A1 describes a method for controlling an electrosurgical HF device, as well as a correspondingly controlled HF device with an associated electrosurgical instrument. The HF generator is initially in a locked state, in which its activation is not possible. After the user activates the HF generator and selects an application to be performed, the HF generator is unlocked. This is intended to ensure that the required device settings are correctly configured before the HF device is activated.

[0004] The aforementioned methods do indeed enable the setting of operating parameters ("operating data" according to EP 1 337 194 B1) on or by an RF generator according to the procedure to be performed, e.g., in general or visceral surgery, and / or according to the preferred settings of a surgeon. These operating data enable, for example, the recording of the device's operating times, the operating date, the set voltage, the "current shape," and the set use of additional devices. However, no intraoperative activation data is recorded that can be stored for later use, such as the activation profile of the RF generator by an activation switch (usually a foot switch) during a specific operation.However, depending on the type of surgery being performed, activation during the activation switch interval can place a significant physical strain on the surgeon's foot and leg muscles. Furthermore, unwanted activations can occur, particularly during intervals with high frequencies. Such strains and potential activations cannot be prevented by simply recording operating data and presetting the device accordingly before surgery, using state-of-the-art methods for controlling / activating surgical RF generators.

[0005] The document DE 29 46 728 A1 discloses a high-frequency surgical device with at least one high-frequency generator for generating high-frequency cutting current and / or coagulation current, in particular for endoscopic incisions and coagulations, wherein a device for generating the high-frequency cutting current and / or coagulation current at predetermined intervals is provided, at which both the duration of the intervals and the pause between successive intervals can be adjusted.

[0006] The object of the present invention was to provide a method for controlling a surgical RF generator for delivering high-frequency current to at least one output thereof, which method does not have the disadvantages of the prior art. Description of the invention

[0007] In a first aspect, the invention relates to a method for controlling a surgical HF generator for delivering high-frequency current to at least one output of the HF generator. It comprises the following steps: reading in the activation of an interval detection signal, followed by detecting an interval actuation of a switching device. A retrievable output profile is then created from the detected interval actuation, and the retrievability of the created output profile for output to the at least one output of the HF generator is signaled. This is followed by reading in an actuation of the switching device to trigger the output of the created output profile, and the output of the created output profile to the at least one output of the HF generator.

[0008] The detection of an interval actuation of a switching device requires that at least one interval is detected by a corresponding evaluation device; thus, at least two actuations of the switching device (two switching signals) are necessary. A switching device is understood to be a component that allows the activation of the surgical HF generator for the delivery of high-frequency current at at least one output thereof. The switching device is preferably a mechanically actuated, electrical component, e.g., a switch connected to the HF generator in the usual way, such as a foot switch. According to the invention, an evaluation device is understood to be a device that is designed, in particular, to process data on the temporal sequence of switching signals. The start or end, i.e., the period of time, of the detection of the interval actuation of the switching device can be defined in a variety of ways, e.g.,indicated by the user, for example via a specific actuation of the switching device, such as a double or triple actuation. Using such a signal sequence, the start and end of the detection of the interval actuation of the switching device can be easily defined. Alternatively, the activation or deactivation of the interval detection can take place on the control module of the HF generator. In a further implementation option, the detection period can also be preset on the device, for example. The detection of the end of the interval actuation of the switching device can also be carried out by the evaluation device. This can, for example, determine the time interval since the last switching signal: when a predetermined limit is reached (e.g. a rest period of 20 seconds), the detection of the interval actuation is ended.The evaluation means can, for example, also determine the deviation of the hypothetical time difference between the last given switching signal and the one still to be given from the mean value of the previous intervals; when a predetermined limit value is reached (e.g., 30% longer interval), the detection of the interval actuation is terminated.

[0009] The creation of a retrievable output profile from the detected interval actuation is carried out by a control module. A control module in the sense of the invention is a control circuit designed as a module, wherein all control-relevant functions, as well as the operating and display elements, including their mechanical and optical functional elements, are integrated in the module. After signaling the retrievability of the created output profile for output to the at least one output of the HF generator by means of signaling means, the control module initiates the output of the output profile when the switching means is actuated again. By means of the signaling means according to the invention, the retrievability of the output profile can be represented, for example, via an acoustic, optical or tactile signal. The actuation of the switching means can be designed in such a way that a specific sequence of switching signals (e.g.a double or triple actuation) triggers the step of outputting the created output profile to at least one output of the RF generator; at the same time, the output of the created output profile can also be terminated or interrupted accordingly via such a switching sequence.

[0010] According to the profile created, high-frequency current is delivered at intervals to at least one RF generator output, for example to one or more supply lines to a surgical instrument.

[0011] The method according to the invention enables the detection of an intermittent actuation of a switching device, such as a foot switch, triggered by the surgeon. The detected actuation during the interval, on which the output pattern is based, can be retrieved by the surgeon simply by actuating the switching device, so that the surgical RF generator is activated at the desired interval. This is particularly advantageous with high activation frequencies of the RF generator, as it significantly reduces the physical strain on the foot and leg muscles and prevents false activations.

[0012] In a preferred embodiment of the method according to the invention, the detection period for the interval actuation can be set using a pushbutton, i.e., the activation or deactivation of the interval detection can be performed using an additional pushbutton, for example, directly on the control module of the RF generator. This button can be pressed at the beginning of the interval detection to activate the interval detection; similarly, it can be pressed at the end of the interval actuation to signal the end of the detection. The activation or deactivation of the interval detection designed in this way is advantageously particularly user-friendly and technically simple to implement.

[0013] In a preferred development of the method according to the invention, the interval actuation can comprise 2 to 50 switching signals from the switching means, which are detected in step (b). Preferably, an evaluation means can determine the period of detection of the interval actuation. A switching signal is a signal caused by the mechanical actuation of the switching means. It is preferably an electrical signal. 2 to 50 switching signals from the switching means can be detected, particularly preferably 5 to 30 switching signals from the switching means, and especially preferably 8 to 20 switching signals from the switching means.

[0014] The detection of switching signals to the extent mentioned enables the creation of a multitude of different output profiles for use in a wide variety of surgical areas. The use of automatic determination of the detection period of the interval actuation of the switching device by an evaluation device also allows for even more convenient application of the inventive method by the surgeon.

[0015] In a further embodiment of the method according to the invention, a continuous actuation of the switching means can be read in when reading in the actuation of the switching means in order to trigger the output of the created output profile. Thus, the output of high-frequency current at the at least one output of the RF generator is possible even after the output of the created output profile has ended. Reading in a continuous actuation of the switching means allows the user, such as a surgeon, to trigger the output of the created output profile at the at least one output of the RF generator in a simple manner, so that the user does not have to remember more complicated trigger signals. Advantageously, the continuous actuation mode for triggering the output of the created output profile can be preset on the RF generator.

[0016] In a preferred embodiment of the method according to the invention, the output of high-frequency current from the at least one HF generator output can be terminated at the end of the reading of the actuation of the switching means for triggering the output of the created output profile. Advantageously, the surgeon can individually control when the output of high-frequency current is terminated by simply "releasing" the switching means, for example by ceasing actuation of the foot switch. For example, after the (pre)determined period of output of the output profile, as described above, the surgeon can continuously continue the output of high-frequency current from the output of the HF generator for a self-selected period, should the surgical procedure require it. Furthermore, the output of the output profile can also be interrupted during its execution by ceasing actuation of the switching means, such as a foot switch.The output of high-frequency current from at least one output of the RF generator can thus be controlled in a simple and user-friendly manner.

[0017] In a further embodiment of the method according to the invention, the retrievable output profile can be saved in an additional step. This saving allows for easy retrieval of the retrievable output profile, for example, at the beginning of an operation, but also in the event that a surgical step needs to be repeated during an operation and a saved output profile for this surgical step is available. Advantageously, the output profile can be saved after the created output profile has been output to the at least one output of the HF generator. In this way, it is possible, for example, to detect interval actuation and thus create the output profile before the operation, and to save the created output profile only when it has proven advantageous for intraoperative use (after a single pass).If the retrievable output profile is not saved, the control module will output the last created output profile to at least one output of the RF generator when the switching device is actuated again.

[0018] In a preferred development of the method according to the invention, the step of outputting the created output profile to the at least one output of the RF generator can be repeated periodically, preferably 1 to 50 times, particularly preferably 3 to 30 times, even more preferably 5 to 10 times. A periodic repetition of the output profile is understood to mean a repetition of the complete profile at regular intervals. The repetition of the step is particularly advantageous for output profiles comprising a small number of intervals (e.g., 2-3) of only a short duration (e.g., 1-2 s). Here, the surgeon can initiate the repeated output of the created output profile to the at least one output of the RF generator by reading in the actuation of the switching means once. Preferably, the repeatability of the output profile is preset on the device, for example, limited to a specific number of repetitions.

[0019] Advantageously, it is also possible to save several different output profiles in parallel or sequentially, which can be accessed individually depending on the operation. This also makes it possible to save individual output profiles for each surgeon.

[0020] In a further embodiment, the invention relates to a method for controlling an RF generator using a stored, retrievable output profile created according to the inventive method described above. It comprises the steps of retrieving the stored, retrievable output profile, reading in an actuation of the switching means to trigger the output of the created output profile, and outputting the stored output profile to at least one RF generator output. Advantageously, this allows an output profile that is preferably used for a specific surgical procedure to be easily retrieved and output.

[0021] In a preferred development of this method according to the invention, continuous actuation of the switching means can be read in to trigger the output of the created output profile; additionally, upon termination of actuation of the switching means, the output of high-frequency current from the at least one RF generator output can be terminated. The output of a stored output profile can thus be easily initiated by the user, such as a surgeon, and can be terminated, for example, individually adapted according to the surgical requirements. For example, after execution of the output profile, continuous output of high-frequency current may be required (output until actuation of the switching means is terminated). If necessary, the output of the output profile can also be interrupted by simply releasing the switching means.

[0022] In a further embodiment, this method may additionally include the step of storing the retrieved output profile. This can advantageously record, for example, the sequence of applications of the retrieved output profile.

[0023] In a further implementation of this method according to the invention, the output of the stored output profile to at least one RF generator output can be repeated periodically, preferably 1 to 50 times, particularly preferably 3 to 30 times, even more preferably 5 to 10 times. As stated above, the repetition of the step is particularly advantageous for output profiles comprising a small number of intervals of only a short duration, since the operator can initiate the repeated output of the created output profile to the at least one output of the RF generator by reading the actuation of the switching means once.

[0024] In an advantageous development of the method according to the invention, the at least one output of the HF generator can be connected to at least one surgical instrument. The surgical instrument can be, for example, an electrode, such as a sliding electrode for vaporizing and / or coagulating tissue, a cutting tool, a gripping tool, or a suturing tool.

[0025] In a further aspect, the invention relates to a surgical HF generator by means of which the method described above can be carried out. The HF generator comprises a control module, signaling means, at least one output of the HF generator for the output of high-frequency current, and at least one switching means. The control module comprises an activatable interval detection device, wherein the interval detection device is designed as an evaluation device adapted to detect an interval actuation of the switching means. The control module, in turn, is adapted to create a retrievable output profile from the detected interval actuation. The retrievability of the created output profile for output at the at least one output of the HF generator is signaled by means of the signaling means designed for this purpose.The control module is further adapted to control the output of the created output profile to at least one output of the RF generator after the signaling means have signaled that the output profile is available for retrieval and after the switching means for triggering the output of the created output profile has been actuated. According to the invention, a control module is understood to be a control circuit designed as a module, wherein all control-relevant functions and all operating and display elements, including their mechanical and optical functional elements, are integrated into the module.

[0026] Advantageously, the interval detection on the control module can be switchable, i.e., activated or deactivated, for example, via a switch. The HF generator constructed in this way enables the implementation of the method according to the invention using conventional components. A switching device is understood to be a component that allows the activation of the surgical HF generator for the delivery of high-frequency current to at least one of its outputs. A signaling device within the meaning of the invention signals the retrievability of the created output profile by means of an acoustic and / or optical signal.

[0027] In a preferred embodiment, the HF generator additionally comprises a user interface adapted to display the interval activation and / or the retrievable output profile. The user interface can, for example, be designed in the form of an interactive display, which advantageously also allows the selection of previously saved output profiles or the targeted storage of created output profiles (e.g., according to surgical procedure and / or surgeon).

[0028] In a further embodiment of the HF generator according to the invention, the switching means can be designed as a foot switch. Using such a switching means, a wide variety of interval actuations can be carried out easily without hindering or interfering with the surgeon's work in the surgical field. Alternatively, a hand switch can be provided on the at least one surgical instrument connected to the at least one output of the HF generator. Short description of the characters

[0029] In the following, some specific embodiments of the invention are described by way of example and not exhaustively, with reference to the accompanying figures. These specific embodiments serve only to illustrate the general inventive concept, but do not limit the invention. Fig. 1 shows a flow chart of the method according to the invention in general form. Fig. 2 shows a flow chart of the method according to the invention, wherein the actuation of the switching means for triggering the output of the created output profile takes place continuously. Preferred embodiment of the invention

[0030] The Fig. 1 shows a flowchart of the method according to the invention in general form. After starting an RF generator adapted to execute an interval detection method, the interval detection can be activated, followed by the detection of an interval actuation of a switching device (when reading: activation of interval detection: "yes"). To execute the method, a corresponding evaluation device must be able to detect at least one interval; thus, at least two actuations of the switching device are required. Preferably, the evaluation device can detect 2 to 50 switching signals, particularly preferably 5 to 30 switching signals, especially preferably 8 to 20 switching signals. The detection of the interval actuation of the switching device by the evaluation device takes place within a defined period of time, whereby the start and end of this period can be indicated, for example, by the user, but can also be predetermined by the device.Preferably, the start and end of interval detection can be specified by the user by pressing a pushbutton. After the detection of the interval actuation, an output profile is created from the actuation intervals. This output profile is the time profile of the high-frequency current to be output at at least one output of the HF generator. The retrievability of the created output profile is signaled by signaling means; for example, these can emit an optical or acoustic signal. If a renewed actuation of the switching means is detected, a control module triggers the output of the output profile at at least one output of the HF generator. The switching means can be actuated in any desired manner; for example, the output of the output profile can be triggered by a single, double, or triple actuation.After the output profile has been output, the delivery of high-frequency current at the at least one output of the HF generator is terminated. The user, e.g., a surgeon, can now save the output profile. If saving is not activated and no further actuation of the switching device is read in, the method is terminated. However, if the switching device is actuated a further time (reading in: actuation of the switching device: "yes"), the last created output profile is output again. The end of the output profile output period also terminates the delivery of high-frequency current. The latter preferably serves to operate at least one surgical instrument connected to the at least one output of the HF generator, for example, a bipolar electrode or a surgical vaporization electrode.

[0031] With appropriate preconfiguration, the output profile can also be repeated. This is particularly advantageous for short output profiles that only cover a few intervals.

[0032] If interval detection is not activated after the system has been started, an output profile is called up. This can advantageously be selected depending on the surgical procedure and / or surgeon. After the actuation of the switching means has been read in, the respectively selected output profile is output, and after the end of the output, the delivery of high-frequency current is terminated, as described above. The output profile can also be repeated periodically in this procedure, preferably in the range of 1 to 50 times, particularly preferably 3 to 30 times, and even more preferably 5 to 10 times. Here, too, the output profile can be saved after this step; this can be advantageous, for example, if an output profile is to be used in a different surgical procedure and / or for a different surgeon.The method for controlling an RF generator described above in general terms enables the simple recording, storage, and output of activation protocols, so that the delivery of high-frequency current by an RF generator can be adapted to a variety of surgical procedures. The surgeon can conveniently select those output profiles that have proven advantageous before the operation and retrieve them intraoperatively. The physical strain on the surgeon and unwanted incorrect activations associated with activating the switching device during the interval, especially at high interval frequencies, are avoided with the method according to the invention.

[0033] In Fig. Figure 2 shows a flowchart of the method according to the invention, wherein the actuation of the switching means for triggering the output of the created output profile occurs continuously. The first steps of the method, which include the activation of the interval detection, the detection of the interval actuation of the switching means, the creation of the output profile, and the signaling of the retrievability of the output profile, are identical to the method described in Fig.1. After signaling the retrievability, the output of the output profile to the at least one output of the RF generator is triggered by a continuous actuation of the switching means. In this configuration, the delivery of high-frequency current is also possible after the output of the created output profile to the at least one output of the RF generator has ended; this can be advantageous, for example, in the case of a vaporization electrode connected as a surgical instrument, in which, after running through a defined output profile to ignite the electrode, the ignited plasma must be permanently maintained for coagulation and vaporization. The termination of the delivery of high-frequency current is triggered by ceasing the actuation of the switching means, for example by simply "releasing" a switching means, for example by ceasing the actuation of the foot switch.Advantageously, the output of the output profile can be interrupted at any time by activating the switching device, thus stopping the delivery of high-frequency current to at least one output of the RF generator. Upon continuous activation of the switching device (reading: activation of the switching device: "yes"), the output profile can be output again.

[0034] In this method, too, the output profile can be repeated with appropriate presetting. This is particularly advantageous for short output profiles that only comprise a few intervals. In this case, when the switching device is no longer actuated, the repeating of the output profile is aborted, and the delivery of high-frequency current is terminated.

Claims

[1] A method for controlling a surgical RF generator for delivering high-frequency current to at least one output of the RF generator, comprising the steps (a) Reading the activation of an interval detection, (b) Detection of an interval actuation of a switching device, (c) Creating a retrievable output profile from the detected interval actuation, (d) Signalling the availability of the created output profile for output to at least one output of the RF generator, (e) reading in an actuation of the switching means to trigger the output of the created output profile, and (f) Outputting the created output profile to at least one output of the RF generator. [2] Method according to claim 1, wherein a period of detection of the interval actuation is set by means of a push button. [3] Method according to one of claims 1 or 2, wherein the interval actuation in step (b) comprises 2 to 50 switching signals of the switching means. [4] Method according to one of the preceding claims, wherein in step (e) a continuous actuation of the switching means is read in. [5] Method according to claim 4, wherein at the end of the actuation of the switching means in step (e) the output of high frequency current from the at least one RF generator output is terminated. [6] A method according to any one of the preceding claims, further comprising the additional step (g) Saving the retrievable output profile. [7] A process according to any one of the preceding claims, wherein step (f) is repeated periodically, preferably 1 to 50 times, more preferably 3 to 30 times, even more preferably 5 to 10 times. [8] A method for controlling a surgical RF generator by means of a stored, retrievable output profile created according to the method of any one of claims 1 to 5, comprising the steps (a)' Retrieving the stored, retrievable output profile, (b)' Reading in an actuation of the switching means to trigger the output of the created output profile, and (c)' Output of the stored output profile to at least one RF generator output. [9] Method according to claim 8, wherein in step (b)' a continuous actuation of the switching means is read in, and wherein upon termination of the actuation of the switching means in step (b)' the output of high-frequency current from the at least one RF generator output is terminated. [10] A method according to any one of claims 8 or 9, further comprising the step (d)' storing the retrieved output profile. [11] A process according to any one of claims 8 to 10, wherein step (c)' is repeated periodically, preferably 1 to 50 times, more preferably 3 to 30 times, even more preferably 5 to 10 times. [12] Method according to one of the preceding claims, wherein the at least one output of the RF generator is connected to at least one surgical instrument. [13] Surgical RF generator adapted to carry out the method according to any one of claims 1-12, comprising a control module, signalling means, at least one output of the RF generator for the delivery of high-frequency current and at least one switching means, characterized by that the control module comprises an activatable interval detection, wherein the interval detection is designed as an evaluation means which is adapted to detect an interval actuation of the switching means, wherein the control module is adapted to create a retrievable output profile from the detected interval actuation, wherein the signaling means are designed to signal the retrievability of the created output profile for output to the at least one output of the RF generator, wherein the control module is further adapted to control the output of the created output profile to the at least one output of the RF generator after signaling the retrievability of the output profile by the signaling means and after actuation of the switching means for triggering the output of the created output profile. [14] RF generator according to claim 13, additionally comprising a user interface adapted to display the interval actuation and / or the retrievable output profile. [15] RF generator according to one of claims 13 or 14, wherein the switching means is designed as a foot switch.

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