EP3046493A1

EP3046493A1 - Method and device for controlling an electrosurgical hf apparatus and hf apparatus

Info

Publication number: EP3046493A1
Application number: EP14766147.4A
Authority: EP
Inventors: Thomas MASER; Heiko Reichle; Anton Keller; Stefan EICK
Original assignee: Aesculap AG
Current assignee: Aesculap AG
Priority date: 2013-09-16
Filing date: 2014-09-10
Publication date: 2016-07-27
Also published as: CN105555216B; JP2019162502A; US10687885B2; JP6816217B2; BR112016005672A2; WO2015036444A1; BR112016005672B1; CN105555216A; JP2016530036A; DE102013110172A1; US20160220299A1

Abstract

The invention relates to a method for controlling an electrosurgical HF apparatus and to a HF apparatus comprising an electrosurgical instrument and a HF generator for producing a HF current, the HF generator being in a blocked state in which its activation is disabled. Before the HF generator can be activated by a user, an application to be executed has to be selected, which unblocks the HF generator.

Description

description

Method and device for controlling an electrosurgical HF device and HF device

The present invention relates to a method and a device for

Control of an electrosurgical HF device and an electrosurgical HF device with an electrosurgical instrument and an RF generator for

Generation of an HF current.

Background of the invention

Surgical RF devices are well known. You will be in the

High-frequency surgery in addition to standard applications such as cutting or coagulation increasingly used in other areas, such as for closing of hollow organs, connecting biological tissue or as part of a

Ablation. A high-frequency current (HF current) is passed through tissue to be treated via an electrosurgical instrument, which changes as a result. In the course of these special applications, the RF delivery is not automatically controlled, metered and terminated by the surgeon, but by an RF generator to which the instrument is electrically connected.

If in the context of the aforementioned, increasingly diverse applications, the electrosurgical instrument variable in different tissue types

(Small intestine, large intestine, rectum, stomach, esophagus), different number of tissue layers or different types of application (resection, anastomosis) should be able to make presets at the associated RF generator / electrical power source, so that this for the respective application can make specific or special process settings. Incorrect setting of certain process parameters may result in unsatisfactory results or even damage to the patient. thats why always ensure that all process parameters are correctly set before activating the device.

State of the art

Concepts for RF activation, i. for supplying the HF current to the instrument, are a central issue in RF devices and known from the prior art. RF activation without appropriate user intervention is prevented by different safety functions on the electrosurgical instrument and / or on the device's RF generator.

US Pat. No. 5,035,695 discloses a method and an instrument for electrocautery with blocking functions which enable safe operation of the instrument under manual control. An electrode of the instrument is slidable by means of a manually operable slide from a retracted into the instrument rest position in a protruding from the instrument cauterization. A blocking switch automatically disconnects the electrode from an RF power source / HF generator when it is in the rest position. In addition, with the electrode in the idle position, the slider mechanically disables activation switches for manual activation of the electrode, while the activation switches in the cauterizing position are released by the slider and manually operated. Unfortunately, the blocking or release of the instrument is done manually by the user without consideration of a generator setting.

European patent application EP 2 168 517 A1 discloses a system and method for manually locking manual switches of a hand-operated one

electrosurgical clamp known for coagulation and tissue cutting. The clamp has two mutually movable jaws, which are to be acted upon for the coagulation of tissue with electricity. A manual switch is to be manually operated by the user of the terminal to activate it. A lock switch is also manually by the user of the terminal from a first position in which an operation of the manual switch is possible, movable to a second position in which an actuation of the manual switch and an activation of the terminal is not possible. In an alternative embodiment, both the hand and the

Lock switch must be electrically closed to allow activation of the terminal. Unfortunately, the blocking or release of the instrument is done manually by the user also without feedback to the generator.

WO2009 / 149799 A1 discloses a surgical device for coagulating and / or cutting biological tissue. It has a bipolar clamp with two jaws for application of RF power, an activation circuit and an RF generator. The activation switch can be used to control the supply of HF current to the terminal. To prevent operating errors, the device has a safety device that interrupts the power supply to the terminal when its jaw parts take a position that is not suitable for coagulation. This is merely to prevent inadvertent activation of the terminal.

From the US patent US 4,655,215 is finally a monopolar

electrosurgical scalpel with a hand control for selective cutting or coagulation known, with specific modes of operation can be selectively prevented. The scalpel has a slide switch, which can be positioned in three different positions on the user side, and via which an activation switch can be locked or released. In a first position is the

Activation switch locked. In a second position, it is to be operated in such a way that either a coagulation current is applied to the blade of the scalpel or no current flows. In a third position, the activation switch is released, so that either a coagulation current or a cutting current can be supplied to the blade of the scalpel or no current flows. The hand control thus ensures that only after appropriate approval by the surgeon coagulation or

Cutting currents can be supplied to the scalpel. With disadvantage takes place the

Activation / adjustment manually by the user of the scalpel, without this being linked to a security function against an incorrect setting.

If an RF device, as described above, be used in many different applications, a variable and wide selection of process parameters is necessary. However, it must be guaranteed that Activation of the device or the process, ie before supplying the HF current to the instrument, an input or control of the corresponding process parameters by the user of the device has been made in order to avoid an incorrect generator setting if necessary.

In the known solutions, RF instruments or devices are operated with fixed process parameters and / or processes. Depending on the particular application, one or more of these parameters, e.g. The amount and course of the RF energy, however, vary and must or should be adjusted accordingly in order to successfully carry out the desired operation on the one hand and to avoid further damage to the tissue on the other hand.

There are also devices known which allow adjustment of the intensity of the RF process on the RF generator. This will give the user the

Possibility to correct the delivery of RF energy (slightly) up or down. After a change in process parameters, all subsequent activations are then carried out with these parameters until a new setting is made. There is a risk that before an activation is forgotten to manually / visually check the process parameters or

although the conditions or requirements for the subsequent application may differ from those of the previous application.

Based on the above-described prior art, the object of the invention is to provide a method and a device for controlling an electrosurgical HF device and such an HF device, wherein it is ensured that before activation of the HF device each required device setting is correct.

This object is achieved on the procedural side by a method for controlling an electrosurgical HF device, which RF device is an electrosurgical instrument and an HF generator / electric power source for

Generation / Provision of an RF power, wherein the RF generator with the electrosurgical instrument is electrically connected to supply the HF current to the instrument due to a user-side activation, in which method

a) the RF generator is in a locked state in which the HF generator is not user-activated,

b) starting from step a) on the user side an application to be carried out with the electrosurgical instrument is manually set (manually),

c) the HF generator automatically goes into an unlocked state after carrying out step b), in which unlocked state the HF generator can be activated on the user side or is activated,

d) the HF generator and / or the electrosurgical instrument connected thereto for activating the desired application is activated on the user side or can be activated, and

e) the HF generator after the user-side activation in step d) automatically merges into the locked state compulsory.

The object is further achieved by the device side by an electronic

Control unit of a (for a) surgical RF device (comprising an electrical power source / RF generator and an electrosurgical instrument), which

Control unit is adapted to be connected to an RF generator / electric power source as a control object with

an input device or a connection for the input device, by means of which a desired application (specific usage of the HF device) can be activated (presettable) on the user side / is activated (preset),

an output device or a connection for the output device for displaying the currently activated / selected application and / or tissue type, and

- A control terminal through which the control unit outputs an enable signal to the RF generator / electrical power source, only if each time before the start with an application (treatment cycle) the desired application has been reactivated on the user side.

The object is further achieved on the device side by an electrosurgical HF device, the electrosurgical instrument and an RF generator / electrical Current source for generating / providing an RF current, wherein the RF generator is electrically connected to the electrosurgical instrument to supply the RF current to the instrument due to a user-side activation, and wherein the RF generator is set up,

to be in a locked state in which the HF generator can not be activated by the user,

by user-setting an application to be performed with the electrosurgical instrument automatically as an obligatory measure to go to an unlocked state, in which unlocked state of the RF generator is user-activated or activated, and

after user-side activation of the connected electrosurgical instrument (termination of the treatment cycle) automatically goes into the locked state.

The RF device according to the invention is in particular for performing the

Method according to the invention set up and suitable. The instrument can be both bi-monopoly and monopolar.

Among other things, the advantage achieved by the invention is that many different applications can be performed with an HF device, whereby the respectively correct setting of process parameters for the respective application is always ensured. Examples of such applications are bowel discontinuation, resection or anastomosis. The invention further enables a

Application with different tissue types (small intestine, large intestine, rectum, stomach, esophagus) as well as with different numbers of tissue layers.

The HF dosage is no longer controlled manually by the surgeon, but automatically controlled by the RF generator and possibly stopped according to the invention. The surgeon or user merely makes a presetting, preferably on the HF generator, which then automatically based on this default setting for the respective application

sets specific process parameters, for example, selects from a database. According to the invention, it is imperative that in order to be able to carry out an activation of the HF generator, the user first has to carry out the operation Application is to be re-selected each time and is selected. Activation of the HF generator on the basis of incorrect process parameters or a wrong application, which can lead to harm to the patient, can therefore be prevented with advantage, since an activation is only possible if the user side

Adjustment of the device or a selection of an application was made again (each time before an application-specific treatment cycle). It can also be prevented with advantage that the setting of the device or a selection of an application is forgotten and thus worked with the wrong device settings.

An application within the meaning of the present application is understood to mean a specific type of surgical application with which the method or HF device according to the invention is or will be used. Connected to the respective

Applications are certain process parameters, such as Current, Voltage, Frequency, Amplitude, Amplitude Shape, Duration of Current Flow, Intensity and their History, Shutdown Point / Termination Criteria, etc. These process parameters must be properly set and applied for the particular application to ensure satisfactory results and prevent patient damage can. Each application is the corresponding process parameters e.g. assigned in a database. This database can be stored in the device or in a storage element in the

Instrument stored.

After the generator has been activated, it will return after completion of the

Treatment cycle (e.g., deactivating the electrosurgical instrument)

automatically returns to the locked state and remains there until an application is re-selected by the user. Only then is the HF generator unlocked again. In this way it is ensured that the device setting is not forgotten. According to one embodiment of the invention, the HF generator automatically returns to the locked state due to the user-side or due to the user-side activation in method step d). According to another embodiment of the invention, it is provided that the HF generator automatically returns to the locked state when a predetermined time after setting an application no activation took place. In addition, the automatic locking, So the return of the RF generator in the locked state (step e)) after a predetermined period of time after completion of the last RF application done. Also, the generator may return to the locked state if a certain number (eg, two) of successive activation requests are detected with the same parameter settings.

The presently described safety device with which an activation of the RF generator and thus a supply of an RF current to the electrosurgical instrument only after a user-side input of an application is possible and the RF generator is otherwise locked, can be according to advantageous embodiments of the invention realize in the form of different designs. The setting or selection of the respective application can be made on the HF device, e.g.

by keystroke, on a screen of the RF device (e.g., with and without a touchscreen device menu), by voice command, by a dial (e.g., a neutral position which must be selected between activations), or on the electrosurgical instrument itself, e.g. by means of a rotary knob (for example, with neutral position, which must be selected between the activations) or by means of buttons on the instrument. The rotary wheel for selecting the application can be additionally pressed in one embodiment, whereby the selected RF process can be started or the selected application can be confirmed.

According to one embodiment, user-side activation of the RF generator is possible only if the selection of the application and the activation, e.g. by pressing an activation key, done simultaneously. According to a particular form of the invention, the selected application is announced by the device. This may be useful if the device setting is not performed by the surgeon himself, but by the surgical staff, and provides the surgeon with advantage a way to make sure before the activation of the RF generator on the correctness of the selected application. After another suggestion can for certain

Operating modes in which a variety of applications with identical or similar parameters are possible, the safety mode can be overcome by deliberate decision of the user, for example by long-term actuation of the Activation device or by fast double or multiple actuation of the activation device.

According to one form of the invention, the described safety device can only be used for certain types of instruments. Advantageously, the instruments can be detected automatically, for example, when connecting to the RF device. The safety device is only switched on if this is stored in the parameters of an instrument memory of the HF device. In this context, data on possible applications can also be stored in the instrument memory.

Further features and advantages of the present invention will become apparent from the following exemplary description of particularly preferred embodiments with reference to the figures. Showing:

1 is a schematic representation of the sequence of a process activation according to a preferred embodiment of the invention,

2 is a schematic representation of a program flowchart for an RF activation according to the preferred embodiment of the invention,

Fig. 3 is a schematic representation of a state diagram of an RF activation and

Fig. 4 shows schematically an RF device to which the invention can be applied.

First, an RF device equipped with the present invention will be described generally with reference to FIG. 4.

Accordingly, the RF device has a possibly interchangeable electrosurgical instrument 1 of known type, for example a bipolar force with two relatively movable scissors and a handle with operation buttons for selectively acting on the scissor branches or electrodes arranged thereon with an HF current.

Such an instrument 1 is connected via an electrical conductor cable (bundle) to an electrical power source, e.g. an RF generator or an RF power amplifier 2

connected, which supplies the instrument 1 with an HF current. Further, an input device 5 is e.g. a keyboard and an output device, e.g. one

Display / monitor 4 provided. It would also be possible to use the monitor as

form so-called touch screen (combined input-output device). Finally, a control unit 3 has or is connected to the current source / generator 2, which activates the current source / generator 2 in accordance with certain conditions for the provision of a specific, application-specific HF current and then optionally controls it. To this control unit 3, the input and output device 4, 5 are connected. It is also conceivable, the input and

Output devices 4, 5 in the control unit 3 to integrate. In general, components 2, 3, 4 and 5 are installed in one device, the generator.

Via the input device 5, the control unit 3 can be set to one of a plurality of previously stored selectable applications (with corresponding operating parameters), as will be described below with reference to FIGS. 1 to 3. The selected application is then displayed in the output device 4. The control unit 3 then operates the RF generator 2 in response to parameters associated with the selected application according to a particular process flow in accordance with the present invention. FIG. 1 schematically shows the sequence of such a process activation.

In a first step, user-defined selection variables are entered. This input can be that, for example, a specific application is selected or determined from a plurality of possible applications

Process parameters are selected. Only by entering the respective

Selection size or the respective application (as a mandatory measure), the automatic blocking of the RF generator 2 is canceled, so that this user-side is activated or is activated. In a second step, after selecting (and inputting) the respective application, the HF process (treatment cycle) is started by a user-side instruction, that is to say the surgical instrument is put into operation and if necessary the HF generator 2 is activated. In a third step, the RF process (treatment cycle) is executed, ie the application selected by the user is executed, wherein the corresponding HF current (corresponding to the selected application

assigned operating parameters) to the instrument 1 is supplied. After this third step, i. after completion of the application (treatment cycle)

For example, when deactivating the electrosurgical instrument 1, the enable signal is canceled by the control unit 3 and the RF generator 2 thus automatically returns to the locked state in which its user-side activation is not possible without an application selected again and thus again Release signal is generated.

FIG. 2 shows, by way of example, a program flow chart for the activation of the HF. After a device start, the value of a Boolean variable "Parameter input" is set to the value "false". As a result, the RF generator 2 is disabled and can not be unlocked or activated on the user side (for example, by operation of the instrument 1).

Subsequently, a decision is made as to whether there is an activation request from a user. If there is no activation request (wrong), the program remains in an endless loop and checks again and again whether a

Activation request is present. If this decision is affirmative (true), the routine goes to the next decision.

In this decision, it is checked whether a selection-size input, ie a selection of an application by the user, has been made via the input device. If this decision is negated (false), ie if no user has selected an application, an error message is output and the routine returns to the initial state in which the variable "parameter input" or "selection input" is set to the value "false". If the decision is in the affirmative (true), the HF Generator 2 unlocked, the operating parameters corresponding to the selected

Application set and the routine can after user activation

for example, execute the selected RF process on the instrument 1.

After executing / terminating the RF process, the Boolean variable "parameter input" is automatically reset to the value "false" and the routine returns to the initial state.

Finally, FIG. 3 schematically shows a state diagram of

HF activation according to the invention. After the device has started, the status "locked" or "locked" is automatically present, meaning that the RF generator 2 is in the locked state in which its user-side activation is not possible , eg by pressing a corresponding activation key, the HF device automatically issues an error message, activation is not carried out.

If a parameter input by the user to select an application to be executed occurs in the locked, ie locked state, the system automatically switches to the unlocked or unlocked state. In this, the user can then perform the activation (once), e.g. by pressing an activation key, and the activation is carried out, i. the HF generator 2 is active and leads the

Instrument to an RF current according to the selected application to then be locked again after the application.

Finally, it should be noted that the subject invention can be changed or supplemented in different ways.

Thus, it is conceivable that the obligatory process of application selection need not be repeated before each treatment cycle but only after a certain number of cycles. This deviation may be all or only certain

be assigned to selectable applications. Also, an additional

Be provided security function about a timer, which after expiration of a determined interval of time after selection of an application, the release signal canceled again although the treatment cycle has not even begun.

In summary, the present invention essentially relates to

Method and device for controlling an electrosurgical HF device, in particular an HF device with an electrosurgical instrument 1 and an HF generator 2 for generating an HF current, wherein the HF generator 2 is in a locked state in which its Activation is not possible, and before a user-side activation of the RF generator 2 compulsory to select an application to be selected, whereby the RF generator 2 is unlocked.

Claims

claims

1 . Method for controlling an electrosurgical HF device, which HF device has an electrosurgical instrument (1) and an HF generator (2) or the like electric current source for generating or providing an HF current,

wherein the RF generator (2) is electrically connected to the electrosurgical instrument (1) for enabling the RF current due to user-side activation

Instrument (1) supply, in which method

a) the RF generator (2) is initially in a locked state in which the HF generator (2) can not be activated by the user,

b) starting from step a) an application to be carried out with the electrosurgical instrument (1) is obligatorily set on the user side,

c) the HF generator (2) automatically switches to an unlocked state after performing step b), in which unlocked state the HF generator (2) can be activated on the user side,

d) the RF generator (2) for performing the desired application

activated on the user side, and

e) the HF generator (2) after the user-side activation in step d) automatically enters the locked state.

2. The method according to claim 1, characterized in that the RF generator (2) automatically passes into the locked state, if it is not activated during a predetermined period of time after a user-side input of an application.

3. The method of claim 1 or 2, characterized in that the RF generator (2) in step a) after switching on the RF device or after performing an application in the locked state.

4. The method according to any one of the preceding claims, characterized

in that the HF generator (2) immediately after activation or with Termination of the activation or automatically after a specified period of time after completion of the activation goes into the locked state.

5. The method according to any one of the preceding claims, characterized

in that an instrument (1) connected to the HF generator (2) is automatically recognized and assigned to a stored data record if it does not carry the data record itself.

6. The method according to claim 5, characterized in that in the

A record is included an instruction according to which the transition of the RF generator (2) in the locked state in the step e) is inhibited and / or the method step e) is carried out automatically after a change of the instrument (1).

7. The method according to any one of the preceding claims, characterized

characterized in that the locked state is canceled when the user side activating means for activating the RF generator (2) for a predetermined period of time or a predetermined number of times is actuated.

8. The method according to any one of the preceding claims, characterized

characterized in that an error or advice message is issued when the user side is trying to activate the RF generator (2, 3, 4, 5) in the locked state.

9. Electronic control unit (3) of a surgical HF device comprising an electric current source or HF generator (2) and an electrosurgical instrument (1), which control unit (3) is adapted to the HF generator or the electric current source ( 2) as a control object to be connected with

an input device (5) or a connection for the input device (5), by means of which a desired application (specific type of use of the HF device) can be activated (presettable) on the user side / activated (preset),

- An output device (4) or a connection for the output device (4) for displaying the currently activated application and - A control terminal (3a), via which the control unit (3) outputs an enable signal to the RF generator / electrical power source (2), only if each time before starting with an application (treatment cycle) the desired application user-side re-activated has been.

10. Electrosurgical HF device, in particular adapted to

Carrying out a method according to one of the preceding claims 1 to 9, which HF device has an electrosurgical instrument (1) and an HF generator (2) for generating an HF current, wherein the HF generator (2) with the electrosurgical instrument (1) is electrically connected to supply the RF current to the instrument (14) due to user-side activation, and wherein the RF generator (2) is arranged,

to be in a locked state in which the HF generator (2) can not be activated by the user,

at least by user-setting an application to be carried out with the electrosurgical instrument automatically to an unlocked state, in which unlocked state of the RF generator (2) and / or the instrument (1) is user-activated, and

after completion of at least one user-side application to automatically go to the locked state.

1 1. Electrosurgical HF device according to claim 10, characterized

in that different instruments can be connected to the HF generator (2).

12. Electrosurgical HF device according to claim 10 or 1 1, characterized by an operating unit (5) for user selection of an application or process parameters, wherein the operating unit (5) a keyboard, keys, tilt or slide switch, a screen, a rotary or a voice instruction / recognition system.

13. Electrosurgical HF device according to claim 12, characterized in that the operating unit (5) on the HF generator (2) and / or on the instrument (1) arranged or is a part thereof.