DEVICE FOR TISSUE TREATMENT AND METHOD FOR ELECTRODE POSITIONING

Abstract

An instrument (14) is suitable for treatment of lung tumors and other tissues and a respective apparatus (15) detects the correct positioning of instrument (14) and its two electrodes (19, 20) in a suitable target tissue by observation of two parameters (G1, G2) and particularly their time-dependent change. If the change (V1, V2) of the two parameters (G1, G2) exceeds defined thresholds (S1, S2) respectively, a contact between the instrument and the tissue to be treated and thus also the positioning of the instrument in a desired position can be derived therefrom. This remarkably increases treatment safety.

Claims

1. An electrosurgical device (10) for electro-thermal treatment of biological tissue (11), the electrosurgical device comprising: an instrument (14) configured to penetrate biological tissue and including a body (18) having a first electrode (19) and at least one second electrode (20) arranged in proximal distance to the first electrode (19) which are configured to be supplied with a radio frequency test voltage (U.sub.T) and with a radio frequency treatment voltage (U.sub.HF); an apparatus (15) that comprises an electrosurgical generator (23) that is configured to supply the first and at least one second electrodes (19, 20) of the instrument (14) with the radio frequency test voltage (UT) and to detect a resulting current (i) thereby; and a control device (24) that is configured to determine from the radio frequency test voltage (UT) and the current (i) a first parameter (G1) that depends on an effective impedance (Imp) between the first and at least one second electrodes (19, 20) and a second parameter (G2) that depends on a phase angle (phi) between the radio frequency test voltage (UT) and the current (i); wherein the control device (24) is further configured to determine whether: a first change (V1) of the first parameter (G1) exceeds a first threshold (S1), and a second change (V2) of the second parameter (G2) exceeds a second threshold (S2).

2. The electrosurgical device according to claim 1, wherein the first change (V1) and the second change (V2) are changes of the first and second parameters (G1, G2), respectively, measured at different points in time.

3. The electrosurgical device according to claim 2, wherein the control device is configured to determine the first change (V1) in that the first parameter (G1) is determined at different points in time (t1, t2) defined in relation to one another by a time interval (Δt), wherein the first change (V1) is determined from a difference of the first parameter (G1) determined at the different points in time (t1, t2).

4. The electrosurgical device according to claim 1, wherein the control device is configured to determine the first and second parameters (G1, G2) as averages, respectively, from multiple subsequent measurements.

5. The electrosurgical device according to claim 3, wherein the control device (24) is connected with an input means (31) configured to adjust the time interval (Δt).

6. The electrosurgical device according to claim 1, wherein the control device is configured to define a value of the first and the second parameter (G1, G2) as a reference parameter (G1B, G2B), if both the first and second changes (V1, V2) have exceeded defined thresholds (S1, S2) in respective first directions.

7. The electrosurgical device according to claim 6, wherein the control device (24) is configured to output a signal, if the first and second parameter (G1, G2) change in a respective second direction starting from the reference parameters (G1B, G2B) that is opposite to the respective first direction.

8. The electrosurgical device according to claim 1, wherein a displacement measurement device (27) is assigned to the instrument and the control device (24) is configured to detect the first and second changes (V1, V2) in a displacement dependent manner, wherein the control device (24) is configured to determine the first and second changes (V1, V2) by differences between the first and second parameters (G1, G2) determined at different instrument positions.

9. The electrosurgical device according to claim 8, wherein the different instrument positions are different positions of the instrument (14) during penetration of the instrument into biological tissue.

10. The electrosurgical device according to claim 1, wherein the first parameter (G1) is an impedance (Imp) and the second parameter (G2) is a power factor (LF).

11. The electrosurgical device according to claim 10, wherein the first change (V1) is a decrease of the impedance (Imp) of a predefined first value.

12. The electrosurgical device according to claim 11, wherein the predefined first value is 60%.

13. The electrosurgical device according to claim 10, wherein the second change (V2) is an increase of the power factor (LF) of a predefined second value.

14. The electrosurgical device according to claim 13, wherein the predefined second value is 20%.

15. A method for tumor localization in healthy tissue using an instrument according to claim 1, the method comprising: penetrating the instrument into biological tissue (11); supplying a radio frequency test voltage (UT) to the electrodes (19, 20) and detecting the resulting current (i); determining from the test voltage (UT) and the current (i) the first parameter (G1) depending on the effective impedance (Imp) between the first and the at least one second electrodes (19, 20) and the second parameter (G2) depending on the phase angle (phi) between the test voltage (UT) and the current (i); and determining whether: the first change (V1) of the first parameter (G1) exceeds the first threshold (S1), and the second change (V2) of the second parameter (G2) exceeds the second threshold (S2).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Additional advantageous details of the invention are subject of dependent claims as well as the description and the assigned drawings. The drawings show:

[0022] FIG. 1 the device according to the invention during treatment of biological tissue in a schematic illustration,

[0023] FIG. 2 the instrument being part of the device according to FIG. 1 during penetration in tissue that needs to be treated,

[0024] FIG. 3 the instrument according to FIG. 2 in a schematic longitudinally cut illustration in part,

[0025] FIG. 4 voltage and current at the instrument during penetration and during treatment,

[0026] FIG. 5 different parameters determined from the voltage and the current in a time-dependent progress as diagram.

DETAILED DESCRIPTION

[0027] A device 10 is illustrated in FIG. 1 that serves for treatment of biological tissue 11, such as lung tissue, that consists of healthy lung tissue 12 and a tumor 13 embedded therein, for example. The device 10 comprises at least an instrument 14 and an apparatus 15 for supply of the instrument 14 with the necessary operating media, e.g. cooling media and current. The instrument 14 can be a flexible probe 16 that can be guided to the target tissue 11, e.g. through a bronchoscope 17.

[0028] During the treatment of other tissue, also other instruments, e.g. an endoscope, instruments for laparoscopic use or also open surgical instruments can be used. The invention is not limited to bronchoscopy.

[0029] The instrument 14 is further illustrated in FIGS. 2 and 3. It comprises a longitudinal body 18, e.g. configured as hose, on which a distal electrode 19 and with distance in proximal direction a second electrode 20 are arranged. The electrodes 19, 20 typically have a length in axial direction between 7 and 10 mm and are electrically insulated with regard to each other. For this purpose they are arranged in a distance of 3 mm to 5 mm in axial direction, for example. The electrodes 19, 20 are realized as cylindrical sleeves, coils or the like, for example, and have a diameter of 2 to 3 mm, for example.

[0030] The electrodes 19, 20 can be supplied with voltage and current via electrical lines that preferably extend through the probe 16 and are connected to the apparatus 15. In FIG. 1 the apparatus 15 comprises an RF generator 23 for this purpose that is controlled by means of a control device 24 in order to either provide a test voltage U.sub.T or a treatment voltage U.sub.HF to the electrodes 19, 20.

[0031] The instrument 14 can surround a lumen 25 to which cooling medium is supplied via a capillary 26 arranged inside lumen 25. This cooling medium can serve to cool the electrodes 19, 20 in order to avoid dry out of the tissue being in contact with the electrodes 19, 20 during treatment.

[0032] As illustrated in FIG. 1, as an option a displacement measurement device 27 can be provided on the bronchoscope 17 by means of which the present position of the probe 16 during insertion in the bronchoscope 17 and during penetration into the biological tissue 11 can be determined. A wheel 28 being in frictional contact with the probe 16 and a resolver 29 can be part of the displacement measurement device, for example. Alternatively, displacement markings can be attached to the coating of probe 16 that can be read by the displacement measurement device 27. It is in addition possible to penetrate probe 16 in an automated manner into the tissue 11. For this purpose a motor 30 can be provided that is drivingly coupled with wheel 28. The resolver 29 or the other displacement measurement device 27 and, if provided, motor 30 are then connected with control device 24.

[0033] The control device 24 can comprise an input means 31, such as a keyboard, a touchscreen or the like, in order to be able to influence its operation. The input means can be configured to input predefined values, e.g. for time periods, voltages, currents, powers, thresholds and the like and to transmit them to the control device.

[0034] The generator 23 is configured to output a treatment voltage U.sub.HF and alternatively a test voltage U.sub.T illustrated in FIG. 4 in the diagram that can have an amount of a few Volts, e.g. only 10 Volts. The test voltage U.sub.T is preferably an alternating voltage, particularly a radio frequency alternating voltage having a frequency over 100 kHz. It is transmitted to the electrodes 19, 20 via lines 21, 22.

[0035] During penetration into the tissue 11 a current i flows between the electrodes 19, 20. Generator 23 comprises respective measurement means in order to detect the current i in its magnitude, but also with regard to its phase position in relation to the test voltage U.sub.T. The measurement means can detect, as an example, the phase angle phi between the test voltage U.sub.T and the resulting current i or a parameter depending from the phase angle phi (e.g. the power factor).

[0036] The generator 23 is in addition configured to output the treatment voltage U.sub.HF that can have an amount of 100 Volts or multiple 100 Volts, for example (however preferably <200 Vp). In addition, generator 23 can be configured to detect thereby the resulting current. However, this is not mandatory.

[0037] The control device 24 is configured to supply the electrodes 19, 20 during penetration of the instrument 14 into the tissue 11 with a test voltage via generator 23. Thereby control device 24 is in addition configured to determine a first parameter G1 from the voltage U.sub.T and the current i that depends on the impedance Imp effective between electrodes 19, 20. This parameter G1 can be, for example, the complex impedance Imp, the real part R=Re{Imp} thereof, the amount |Imp| thereof or another parameter derived therefrom, e.g. the conductance Imp.sup.−1. The first parameter G1 can also be represented by other parameters derived from the impedance Imp.

[0038] In addition, control device 24 is configured to determine a second parameter G2 that depends, for example, from the phase angle phi between current i and test voltage U.sub.T. The second parameter G2 can be, for example, the power factor LF=cos(phi). The power factor LF can also result from the quotient of the effective power P transferred into the tissue 11 and the apparent power S, LF=P/S.

[0039] In addition, control device 24 is configured to determine the change V1 of first parameter G1 and the change V2 of second parameter G2. As an example, the change can be the time-dependent change. For this purpose a floating average can be created from the first parameter G1 and the difference of this average between two points in time can be determined. The two points in time t1, t2 can have a distance of a non-varying defined time interval Δt. The time interval Δt can be a time interval that can be input by means of the input device 31, for example. It can be, for example, between 0.1 and 5 seconds and can be adjusted to two seconds, for example. In doing so, the first change V1 is the difference between the first parameter G1 at a point in time t2 and a point in time t1 that have a distance from one another about the time interval Δt.

[0040] These circumstances are illustrated in FIG. 5. Also the second change V2 can be understood as difference of the second parameter G2 between two different points in time t1, t2. This difference is in turn preferably determined between average values of the second parameter G2. For example, the second parameter G2 is the floating average of the power factor. In this example the difference is determined from the floating average of the power factor LF at the point in time t2 and the floating average of the power factor LF at the point in time t1.

[0041] The control device 24 is configured to determine the two changes V1 and V2 during penetration of the instrument 14 into the tissue 11. This is illustrated in FIG. 5. First, the two electrodes 19, 20 are located in lung tissue 12 on the very left in FIG. 5. The impedance or its amount and thus the parameter G1 are on a comparably high value above 300 Ohms. The power factor LF is in a range of cosine phi<0.75.

[0042] At a point in time t0 electrode 19 gets in contact with tumor 13. During continued penetration of instrument 14 into the tumor 13 the impedance starts to decrease gradually. Concurrently the power factor LF increases gradually. As soon as the second electrode 20 also penetrates into tumor 13 (point in time t1), the impedance Imp starts to decrease quicker and the power factor LF starts to increase quicker. This is apparent in FIG. 5 in section A by the steeper decrease of curve of G1 and the steeper increase of curve of G2 in the time window Δt (it is indicated that the progress of the parameters G1 and G2 in FIG. 5 is illustrated based on the floating average respectively, i.e. a sequence of measurement values, e.g. within a passed interval of 1 second, is processed to obtain an average value for determination of the parameter G1 and the parameter G2 respectively).

[0043] If the amount of the difference of the floating averages of G1 in the interval A, i.e. a change V1, exceeds 60% and the change V2 (i.e. the amount of the difference of the floating average of G2 in the interval A) exceeds 20%, the control device 24 can carry out different actions, depending on the configuration. A first option is the immediate output of a signal that indicates the operator that both electrodes 19, 20 are sufficiently located inside tumor 13. In doing so, the treatment of tumor is released. A second option is the output of the signal after a non-varying or adjustable waiting period. This considers the circumstance that the changes V1 and V2 already fulfill the above requirements in most cases before the proximal electrode is completely penetrated into the tumor. The waiting period, e.g. 1 second, results in that the user moves the probe somewhat deeper into the tumor. The treating person can now switch the generator from the test mode into the treatment mode and can thus apply the treatment voltage to the electrodes 19, 20. This can be carried out manually as well as automatically by means of the control device 24 in a modified embodiment.

[0044] In another variant the control device 24 can also store the parameters G1 and G2 at the end of phase A as reference parameters G1B, G2B and can output a signal only if both parameters G1, G2 start to change in an opposite sense, as illustrated in FIG. 5 in section B.

[0045] The device 10 described so far operates as follows:

[0046] After connection of instrument 14 to the apparatus 15, instrument 14 is guided to the tissue 11 to be treated through the bronchoscope 17. The instrument 14 is then moved out of the bronchoscope 17 in distal direction and is penetrated into the tissue 11. As soon as the electrodes 19, 20 of instrument 14 are no longer visible by the user, the treating person activates generator 23 in the test mode, such that it outputs the test voltage U.sub.T to the electrodes 19, 20 of instrument 14. Thereby generator 23 applies a low sinusoidal alternating voltage of, for example, less than 10 V.sub.p (Volt peak) having a frequency of, e.g. 350 kHz with power limitation of 1 Watt to the instrument 14. The test voltage U.sub.T and the current i resulting therefrom have no thermal effect on the tissue 11 due to their low power.

[0047] In the test mode instrument 14 is forwarded further inside tissue 11, whereby the impedance Imp and the phase angle phi or parameters G1, G2 derived therefrom, such as the power factor LF, are determined and stored in defined time intervals (e.g. in a distance of 0.1 milliseconds). As long as the instrument 14 is located in the lung tissue 12, the impedance Imp is in the range of above 300 Ohm and the power factor LF is typically less than 0.75.

[0048] As soon as the distal electrode 19 of instrument 14 gets in contact with tumor tissue 13, the impedance Imp as well as the power factor LF start to change in a characteristic manner. Thereby the ablation instrument 14 is further penetrated into the tumor tissue 13.

[0049] If the change V1 of the present value of the impedance Imp compared to an impedance Imp prior to a defined time interval (e.g. Δt=2 seconds) exceeds a threshold S1 (e.g. 60%) and concurrently the change V2 of the present power factor LF compared with the power factor LF 2 seconds ago exceeds a threshold S2 (e.g. 20%), these momentary values of the impedance Imp and the power factor LF are defined as tumor values. The control device can be configured to store the present values G1 and G2 as reference values G1B and G2B.

[0050] Instead of a time interval Δt of two seconds depending on the treating person, also other time intervals can be adjusted and used. A change of this time interval Δt can be carried out by means of the input device 31.

[0051] The user now moves the instrument 14 further through the tumor 13. As soon as the control device 24 detects an increase of the currently calculated average of the calculated floating average of the impedance value and a decrease of the floating average of the power factor (FIG. 5, section B), the control device indicates a signal to the user that indicates that the instrument is now again in contact with lung tissue. This means that the instrument 14 with its electrodes 19, 20 is located non-symmetrically inside tumor 13 or has completely penetrated through tumor 13. The user recognizes this situation based on the signal which is, for example, displayed on a display arranged on the apparatus 15 and can retract the ablation instrument. In this way the user finds a position that is suitable for treatment. The signal output can be carried out in section B, if the changes V1, V2 exceed a respective threshold. The thresholds can be identical to the thresholds S1 and S2 or can be different therefrom.

[0052] In a modified embodiment control device outputs in section A (FIG. 5) a first signal and in section B a second signal, such that the user finds the correct position of the instrument 14 between the sections A and B.

[0053] An instrument 14 is suitable for treatment of lung tumors and other tissues and a respective apparatus 15 detect the correct positioning of instrument 14 and its two electrodes 19, 20 in a suitable target tissue by observation of two parameters G1, G2 and particularly their time-dependent change. If the change V1, V2 of the two parameters G1, G2 exceeds defined thresholds S1, S2 respectively, a contact between the instrument and the tissue to be treated and thus also the positioning of the instrument in a desired position can be derived therefrom. The invention thus remarkably contributes for increasing treatment safety.

LIST OF REFERENCE SIGNS:

[0054] 10 device [0055] 11 biological tissue [0056] 12 healthy lung tissue [0057] 13 tumor [0058] 14 instrument [0059] 15 apparatus [0060] 16 probe [0061] 17 bronchoscope [0062] 18 base body [0063] 19 first electrode [0064] 20 second electrode [0065] 21, 22 lines [0066] 23 generator [0067] 24 control device [0068] 25 lumen [0069] 26 capillary [0070] 27 displacement measurement device [0071] 28 wheel [0072] 29 resolver [0073] 30 motor [0074] 31 input means