Laparoscopic manipulator and system for laparoscopic ablation

Abstract

The invention relates to a device for laparoscopic surgery and a system for laparoscopic ablation. The device for use in laparoscopic surgery has: a rod having a distal end and a proximal end; a holding unit provided at a distal end of the rod and configured to hold and / or release tissue; at least two electrodes integrated in the holding unit; a force transmission unit provided on the rod and connected to the holding unit for moving relative to the rod; and an electrical wire disposed within the rod, connected to the at least two electrodes, for transmitting an electrical signal received through the proximal end of the rod to the at least two electrodes.

Description

Technical Field

[0001] This invention belongs to the field of minimally invasive medicine, with a particular focus on ablation technology. Specifically, this invention focuses on irreversible electroporation (IRE), an advanced method in interventional medicine for targeted tissue treatment. Taking into account tissue selectivity, shortened treatment time, and minimized risks associated with traditional treatments, this technology represents a significant advancement in medical therapy and has already been achieved for ablation of cardiac tissue. Background Technology

[0002] In recent years, the use of pulsed electric fields to treat tissues has become an increasingly important clinical technique. However, research on short, high-voltage electric pulses and the associated high field strength generated in tissues has a history of over forty years. This application is classified as non-thermal therapy because it is based on emitting short pulses with high voltage amplitudes that generate localized strong electric fields of up to several kilovolts per centimeter between active electrode pairs. This field strength causes transient pores to form on the cell membrane. If the electric field exceeds a specific threshold required to form pores in the lipid bilayer of the cell membrane, and the tissue is exposed to this field for more than a critical time, the cells die due to apoptosis.

[0003] Pulsed electric field ablation has proven to be a very promising treatment for cardiac arrhythmias such as atrial fibrillation. On the other hand, neuromodulation of nerves using pulsed high-voltage electrical signals remains the subject of numerous research projects. One important area of ​​research in this field involves renal denervation. This involves methods to suppress elevated sympathetic nerve activity in the treatment of hypertension or other cardiovascular diseases. Current treatment methods are minimally invasive procedures in which a specialized catheter is used to sever the nerve bundles surrounding the renal artery. Here, the catheter is introduced into the renal artery, and the nerve fibers extending lateral to the artery are ablated through the vessel wall using thermal or chemical ablation methods.

[0004] While the aforementioned minimally invasive endovascular catheter-based methods for neuromodulation are considered promising treatment options, some studies have questioned their effectiveness. For example, because renal sympathetic nerve fibers are located outside the arteries and therefore cannot be directly accessed via catheters, laparoscopic perivascular neuromodulation surgery may be a very promising alternative. In this approach, nerve fibers can directly contact laparoscopic ablation instruments, thereby increasing the likelihood of treatment success.

[0005] Irreversible electroporation (IRE) is essentially a non-thermal ablation method that uses very low electrical energy, thereby raising the tissue temperature by only a few degrees Celsius. This is significantly different from traditional radiofrequency ablation (RF), which raises tissue temperature by 20°C to 70°C and destroys cells through heat. Muscle contraction often occurs when using direct current voltage; to minimize this, IRE typically uses bipolar pulses, a combination of positive and negative electrical pulses. These pulses can be applied between the two bipolar electrodes of the applicator, or between the applicator electrodes and surface electrodes typically placed on the patient's back.

[0006] For an IRE pulse to create porosity in tissue, the electric field strength E defined by the pulse on the tissue must exceed a tissue-related threshold Eth between a pair of electrodes consisting of at least two electrodes. For example, the threshold is approximately 500 V / cm for cardiac cells and 3000 V / cm for bone. These differences in thresholds allow IRE to be selectively applied to different tissues. To achieve the desired field strength, the voltage applied to the electrode pair depends on the target tissue, the distance between the electrodes, and the size of the electrodes themselves. Similarly, these parameters also affect the thermal energy input during ablation, thus influencing the peak temperature that may occur in the treated tissue. The applied voltage can reach several kilovolts, significantly higher than the typical 10-200 V voltages in radiofrequency ablation.

[0007] Currently available neuromodulation systems for nerves, particularly those used in renal denervation, employ transvascular catheter-based approaches using radiofrequency energy or ultrasound. However, a common drawback of transvascular neuromodulation is the need to penetrate the vessel wall for ablation to cauterize the external nerve bundles. To address this issue, another treatment method is the use of a laparoscopic manipulator. The manipulator is inserted into the patient's trunk, allowing for perivascular treatment of nerves around arteries from the outside. This reduces the energy input required by the tissue, potentially increasing the success rate of neuromodulation while minimizing the risk of vascular damage.

[0008] EP 4335397 A1 describes a laparoscopic system for perivascular nerve modulation, such as renal denervation. It describes an ablation device comprising an electrode unit that surrounds a segment of tubular tissue to denervate nerves via thermal ablation methods (e.g., radiofrequency ablation).

[0009] There is a need to improve ablation methods. Summary of the Invention

[0010] This invention relates to laparoscopic ablation, and more particularly to laparoscopic-based neuromodulation.

[0011] The apparatus according to claim 1 and the system according to claim 15 are proposed for this purpose.

[0012] According to a first aspect of the invention, a device for laparoscopic surgery is provided, the device having a rod. The rod has a distal end and a proximal end. The device also has a holding unit disposed at the distal end of the rod. The holding unit is configured for holding and / or releasing tissue. The device has at least two electrodes integrated in / on the holding unit. These electrodes may be directly and / or fixedly connected to the holding unit. The device has a force transmission unit disposed on / in the rod and connected (e.g., indirectly) to the holding unit for movement relative to the rod. The device has electrical wires disposed within the rod and connected, in particular, conductively connected, to the at least two electrodes, and for transmitting electrical signals received through the proximal end of the rod to the at least two electrodes, particularly for performing irreversible electroporation on / within the held tissue.

[0013] This device can also be called a laparoscopic manipulator. It may have a cannula for inserting a rod through / into the patient's torso.

[0014] The device may also have a joint mechanism. This joint mechanism may be disposed between the retaining unit and the distal end of the rod. The joint mechanism may be located at and / or connected to the distal end of the rod (particularly directly connected). The joint mechanism can be used to connect, particularly movably connect, the distal end of the rod to the retaining unit. Movement of the force transmission unit can cause movement of the retaining unit and / or retention and / or release of tissue by means of the force transmission unit. Movement of the force transmission unit can cause movement of the joint mechanism, which in turn can cause movement of the retaining unit and / or retention and / or release of tissue.

[0015] The holding unit can be designed as a finger gripper, especially a two- or three-finger gripper. The force transmission unit can be designed as a push-pull lever. Movement of the push-pull lever, especially movement relative to the lever, can cause the finger gripper to open or close to grasp / clamp or release tissue.

[0016] The device may have a longitudinal axis, a transverse axis, and a hochachse axis. The rod may extend along the longitudinal axis. The push-pull rod may move along the longitudinal axis. The movement of the push-pull rod along, in particular, the longitudinal axis, can cause the finger gripper to open along the vertical and / or transverse axes, especially in the plane of the vertical and longitudinal axes.

[0017] The fingers of the finger gripper each have an inner surface that contacts and / or holds tissue, particularly when the finger gripper is closed. At least two electrodes, particularly ablation electrodes, and especially at least one of a plurality of electrodes, may be integrated on at least one of the at least two inner surfaces. At least two of the plurality of electrodes may be designed as ablation electrodes. At least three of the plurality of electrodes may be designed as measurement electrodes.

[0018] The holding unit can be designed as an adsorption unit. Movement of the force transmission unit causes the adsorption unit to tilt relative to the rod, for example at any angle, particularly including angles between 0° and 90°, especially in the planes of the vertical and longitudinal axes. The adsorption unit is configured to adsorb tissue and / or fix it to or detach it from tissue.

[0019] The adsorption unit may have an adsorption tank. The adsorption unit may have at least one adsorption pore disposed in the adsorption tank. The adsorption unit may have an adsorption channel connected to at least one adsorption pore. The adsorption unit may have an adsorption interface disposed at one end of the adsorption channel. An external vacuum pump can be connected through this adsorption interface to generate negative pressure in the adsorption tank and adsorb tissue onto / into the adsorption tank, or to separate tissue by turning off the external vacuum pump or reducing the negative pressure in the adsorption tank.

[0020] The adsorption tank can be elliptical along the vertical axis, especially in the shape of a moving field or a circle. At least two electrodes, especially ablation electrodes, can be arranged in the adsorption tank along the vertical axis and / or transversely to the vertical axis.

[0021] The adsorption tank can have both a width and a length. It can be made of a flexible material. For example, the width of the adsorption tank can be (slightly) adjusted when adsorbing tissue. Therefore, the adsorption tank can be adapted to the structure and / or shape of the tissue to be adsorbed.

[0022] The adsorption tank can be elliptical along the vertical axis, particularly in the shape of a motion field or a circle. At least three electrodes, particularly measuring electrodes (e.g., which may be attached to the at least two electrodes), are arranged along and / or transversely to the vertical axis within the adsorption tank, particularly spaced apart from the at least two electrodes by a first electrode spacing. At least two / three electrodes can be arranged along the vertical axis in the upper / lower region of the adsorption tank, while at least three / two electrodes can be arranged transversely to the vertical axis in the lower / upper region of the adsorption tank. More specifically, at least two electrodes (e.g., ablation electrodes) can be arranged along the vertical axis in the upper region (within) of the adsorption tank, while at least three electrodes (e.g., measuring electrodes) can be arranged transversely to the vertical axis in the lower region (within) of the adsorption tank. Alternatively, at least three electrodes (e.g., measuring electrodes) can be arranged along the vertical axis in the lower region (within) of the adsorption tank, while at least two electrodes (e.g., ablation electrodes) can be arranged transversely to the vertical axis in the upper region (within) of the adsorption tank.

[0023] The holding unit can be configured as a shell gripper, especially a two-shell gripper. Movement of the force transmission unit causes the shell gripper to tilt relative to the rod, for example at any angle, particularly including angles between 0° and 90°, especially in the planes of the vertical and longitudinal axes, and / or causes the shell gripper to open and / or close.

[0024] The shell gripper can extend / expand along the horizontal axis and / or have a maximum extension. The shell gripper can be configured to open or close along the vertical axis. At least two electrodes (at least one of the two electrodes) can be integrated, particularly along and / or transversely to the vertical axis, into one inner side, particularly into the inner side of at least or only one (e.g., each) shell. At least two electrodes (particularly ablation electrodes), particularly along and / or transversely to the vertical axis, can be integrated into the inner side of each shell.

[0025] The shell gripper can extend / expand along the transverse axis and / or have a maximum extension. The shell gripper is configured to open or close along the vertical axis. On one inner side, particularly the inner side of at least or only one (e.g., each) of the shells, for example attached to at least two electrodes (particularly ablation electrodes), at least three electrodes (at least one of the three electrodes), particularly measuring electrodes, can be integrated therein, particularly oriented / extending along and / or transverse to the longitudinal axis and / or spaced apart from said at least two electrodes by a second electrode spacing. At least three electrodes, particularly measuring electrodes, particularly oriented / extending along and / or transverse to the longitudinal axis, can be integrated on the inner side of each shell.

[0026] The at least two / three electrodes may be located along the longitudinal axis in the upper / lower region of the inner side of the housing, while the at least three / two electrodes may be located transversely to the longitudinal axis in the lower / upper region. Alternatively, more specifically, at least two electrodes (e.g., ablation electrodes) may be positioned along the longitudinal axis in the upper region of the inner side of the housing, while at least three electrodes (e.g., measurement electrodes) may be positioned transversely to the longitudinal axis in the lower region of the inner side of the housing. Alternatively, at least three electrodes (e.g., measurement electrodes) may be positioned along the longitudinal axis in the lower region of the inner side of the housing, while at least two electrodes (e.g., ablation electrodes) may be positioned transversely to the longitudinal axis in the upper region.

[0027] The force transmission unit can be configured as a first push-pull rod, which is disposed within the rod and connected to the joint device. Movement of the first push-pull rod can cause the shell gripper to open or close. The force transmission unit can also be additionally configured as a second push-pull rod, which is disposed within the rod and connected, for example, only to the shell gripper. Movement of the second push-pull rod causes the shell gripper, particularly in the longitudinal-transverse plane, to tilt relative to the rod at any angle (especially including angles between 0° and 90°).

[0028] The force-conducting unit and the holding unit can be configured as associated shape memory materials, particularly shape memory alloys. The holding unit can be configured as a capture structure, particularly a capture basket. Movement of the force-conducting unit can cause it to move out of the rod and the capture structure, particularly the capture basket, to unfold, or cause it to retract into the rod and the capture structure, particularly the capture basket, to fold.

[0029] The capture structure, particularly the capture basket, may have two independent and three associated racks (splines). At least two electrodes, particularly ablation electrodes, and / or at least three electrodes, particularly measuring electrodes (with at least two additional electrodes), are integrated on these racks, particularly on the associated racks. The three associated racks may be approximately shaped as two motion fields joined together along their longitudinal edges.

[0030] According to a second aspect of the invention, a system for laparoscopic ablation, particularly for perivascular nerve modulation, is provided. The system includes a device according to a first aspect of the invention. The system includes a signal generator device connected to or capable of being connected to the device. The system further includes a control and analysis unit connected to or capable of being connected to the device and / or the signal generator device.

[0031] The signal generator device may have a first signal generator for generating a first signal, particularly a radio frequency (RF) signal; and a second signal generator for generating a second signal, particularly a signal for pulsed field ablation.

[0032] Its advantage lies in the ability to combine radiofrequency signals and pulsed field ablation within a single system, shortening the entire laparoscopic ablation process. This typically requires two separate systems, one using radiofrequency signals and the other pulsed field ablation, which must be inserted alternately into the patient's chest cavity.

[0033] The control and analysis unit is configured to control the first signal generator and / or the second signal generator to emit signals.

[0034] The control and analysis unit is configured to control a first signal generator and / or a second signal generator to emit signals based on at least one electrode temperature. The control and analysis unit is configured to control the first signal generator to emit a signal when the electrode temperature is below a temperature boundary value. The control and analysis unit is configured to control the second signal generator to emit a signal when the electrode temperature approaches or exceeds the temperature boundary value.

[0035] The control and analysis unit is configured to apply current to at least two electrodes and / or measure voltage through at least three electrodes, wherein the neural activity and / or local tissue impedance of the tissue can be determined from the current and the voltage.

[0036] According to a third aspect of the invention, a method for perivascular and / or perineural neuromodulation is provided. The method includes inserting an actuator into a patient. The method includes positioning a distal end of the actuator on a blood vessel, tissue, or nerve in the patient. The method includes positioning the distal end of the actuator on the blood vessel, tissue, or nerve in such that at least two electrodes of the actuator make perivascular and / or perineural contact with the perivascular or perineurial area of ​​the blood vessel, tissue, or nerve. The method includes denervation by releasing energy through at least two electrodes. The energy release is performed according to a protocol comprising at least one pulsed field ablation (PFA) pulse. The method includes removing the actuator.

[0037] Irreversible electroporation can be achieved by the method according to the third aspect of the present invention.

[0038] Reversible electroporation can be achieved by means of the method according to the third aspect of the present invention.

[0039] The distal end of the manipulator can be positioned on a blood vessel, tissue, or nerve, or alternatively on tissue. A generator system can be configured to perform denervation. The generator system can be electrically connected to / integrated into, or electrically connected to at least two electrodes located at the distal end of the manipulator.

[0040] The manipulator can be introduced laparoscopically. Alternatively or additionally, the manipulator can be removed laparoscopically.

[0041] A laparoscopic manipulator can be inserted into the patient's torso via a cannula. The manipulator may have a cannula. The manipulator may also include a lever with distal and proximal ends. The distal end may be equipped with multiple electrodes, for example.

[0042] The manipulator can be inserted via open surgery (chirurgisch). Alternatively or additionally, the manipulator can be removed via open surgery.

[0043] After the manipulator is inserted, geometric unfolding of the distal end of the manipulator can be triggered. This allows the distal end to conform to a shape resembling a blood vessel, tissue, or nerve. Unfolding can be achieved through mechanical, magnetic, or material-based control.

[0044] The electrodes of the manipulator can come into contact with (target) blood vessels, tissues, or nerves.

[0045] The method also includes checking the positioning of the manipulator through local impedance measurements. For example, the positioning of the manipulator can be considered complete when at least two electrodes are in contact with a blood vessel, tissue, or nerve. Positioning checks can then be performed.

[0046] The protocol may, for example, include only the PFA pulse.

[0047] The protocol may include a combination of PFA pulses and radio frequency (RF) pulses.

[0048] The method also includes the option of performing denervation energy release via a protocol utilizing PFA pulses or a protocol utilizing a combination of PFA pulses and RF pulses.

[0049] Single or multiple energy releases can be performed at the same or different locations in blood vessels, tissues, or nerves. Energy release can be achieved using PFA pulses or a combination of PFA pulses and RF pulses.

[0050] Denervation can achieve perivascular and / or perineural neuromodulation. This eliminates the need for neuromodulation through the blood vessel wall and avoids this process altogether.

[0051] The method of the present invention further includes quantifying the conductivity of blood vessels, tissues, or nerves using at least two stimulation and measurement electrodes prior to performing denervation. The quantification of conductivity can be performed using a stimulation and measurement device having stimulation and measurement electrodes located distal and proximal to at least one ablation electrode.

[0052] The method of the present invention further includes characterizing the denervation using at least two stimulation and measurement electrodes after the denervation is performed. The characterization of the denervation can be performed using a stimulation and measurement device having stimulation and measurement electrodes located distal and proximal to at least one ablation electrode.

[0053] During the process, the temperature of the selected ablation site can be measured. In other words, the method of the present invention may also include measuring the temperature of the selected ablation site during the process. Attached Figure Description

[0054] Other features, characteristics, advantages, and possible modifications of the present invention will become more apparent to those skilled in the art upon reference to the accompanying drawings and the following description. The drawings schematically illustrate:

[0055] Figure 1 The illustration schematically depicts a biphasic IRE pulse corresponding to a variation of one embodiment;

[0056] Figure 2 The illustration schematically depicts a pulse protocol with multiple biphasic pulse clusters, corresponding to a variation of one embodiment.

[0057] Figure 3 The schematic illustration shows a process protocol with at least one biphase IRE pulse cluster and at least one RF energy cluster 120 combined, corresponding to a variation of one embodiment;

[0058] Figure 4 An embodiment of the distal portion of a laparoscopic manipulator is shown;

[0059] Figure 5 The diagram illustrates the control of the electrodes previously described for implementing the neuromodulation method;

[0060] Figure 6 An embodiment of the distal portion of a laparoscopic manipulator is schematically shown;

[0061] Figure 7 The schematic diagram illustrates the electrode layout inside the adsorption tank and the control possibilities for implementing the neural modulation process.

[0062] Figure 8 An embodiment of the distal portion of a laparoscopic manipulator is shown;

[0063] Figure 9 Another embodiment of the distal portion of the laparoscopic manipulator is shown;

[0064] Figure 10 The process of performing laparoscopic neuromodulation is illustrated using the denervation process as an example. Detailed Implementation

[0065] Figure 1A schematic illustration shows a biphasic IRE (Irreversible Electroporation) pulse corresponding to a variation of one embodiment. It shows the voltage V of the biphasic PFA pulse 100 as a function of time t during the IRE ablation process. In this embodiment variation, a second signal generator is configured as a voltage source, acting as an IRE generator. Therefore, the IRE signal is described herein in voltage form. The biphasic IRE pulse 100 comprises a positive pulse 101 and a negative pulse 104, where the terms "positive" and "negative" refer to the independently selected polarities of the two electrodes controlled for ablation, and the biphasic pulse is applied between these two electrodes. The amplitude of the positive pulse 101 is denoted as kV+, and its duration is 102. Similarly, the amplitude of the negative pulse 104 is denoted as kV-, and its duration is 105. A delay time 103 exists between the two pulse phases 101 and 104. The two pulse time widths of 102 and 105, as well as the amplitudes kV+ and kV-, can be configured independently, and therefore may differ in exemplary embodiments of the present invention.

[0066] Figure 2 The diagram schematically illustrates a pulse protocol with multiple biphasic pulse clusters, corresponding to a variation of one embodiment. Throughout the duration of the IRE process 113, pulses 100 are emitted in the form of one or more clusters or pulse packets 110. Each cluster 110 comprises a specific number N of biphasic pulses 100, separated by time intervals 111. A delay time 112 exists between the release of individual clusters 110.

[0067] Figure 3 A process protocol corresponding to a variation of one embodiment, comprising at least one biphasic IRE pulse cluster and at least one RF energy cluster 120, is schematically illustrated. Throughout the duration of the combined process 113, the RF energy and IRE pulses are emitted in the form of one or more clusters 120 and 110. Each IRE cluster comprises a number N bipolar pulses 100, separated by a time interval 111. The RF cluster is described by a sinusoidal signal having an amplitude RF_A and a duration 121. A delay time 122 follows the RF cluster. The duration of the RF cluster and the subsequent delay time 122 can be adjusted according to the currently measured temperature on the ablation electrode. A delay time 112 exists between the release of a single IRE cluster 110. A delay time 123 exists between the release of an IRE cluster and the re-release of the RF cluster.

[0068] Figure 4A variation of an embodiment of the distal portion of a laparoscopic manipulator is shown. The manipulator has a lever 201, which can be introduced through a cannula 210 through the patient's torso. Inside the lever 201, there is a push-pull lever 200, which is free and movable relative to the lever along the longitudinal axis Lx. At the distal end of the manipulator, there are three-finger grippers 206, 207, comprising a two-finger portion 206 and a one-finger portion 207. Each of the three fingers has an inner side, specifically a concave shape. The three-finger grippers 206, 207 are configured to grasp cylindrical tissue structures whose circumference is formed around the transverse axis Ly. The cylindrical tissue structure has a longitudinal extension parallel to the transverse axis Ly of the laparoscopic manipulator. To achieve the clamping mechanism, the three-finger grippers 206 and 207 are connected to the external rod 201 and the internal push-pull rod 200 via joint devices 202, 203, 204, and 205, such that movement of the push-pull rod 200 along the longitudinal axis Lx causes clamping by the three-finger grippers. Therefore, the clamping distance 208 is variable and can adapt to different tissue structures. Multiple electrodes 209_n are integrated in the recesses of the three-finger grippers 206 and 207. Each recess has one electrode. Each electrode 209_n is connected to an analysis and control unit (not shown) and a signal generator system (not shown) via electrical connections located inside the rod 201. These electrodes are each exposed to the external environment, while the electrical connections to the control unit and generator system are isolated from the external environment. In a variation of this embodiment, the electrodes are designed as ablation electrodes, thereby enabling laparoscopic ablation.

[0069] Figure 5 A schematic diagram is shown of the control of the aforementioned electrode 209_n for a neuromodulation method. In this embodiment, electrodes 209_2 and 209_3 are located on the two-finger portion 206, and electrode 209_1 is located on the one-finger portion 207. Control option 1 is intended to generate an electric field radially. For this purpose, two voltages Vr are applied between electrode pairs 209_2 and 209_1 and between electrode pairs 209_3 and 209_1. When all electrodes are in contact with the tissue structure, a radially directed current is generated. In control option 2, an electric field generated by applying voltage Va between electrode pairs 209_2 and 209_3 induces a current directed along the horizontal axis Ly. Electrode 209_1 is not functional here and is in an electrically floating state.

[0070] Figure 6Another embodiment of a modified laparoscopic manipulator is shown. The manipulator has an external rod 301, which is introduced through the patient's torso via a cannula 310. Inside the rod 301, a push-pull rod 300 is provided, which is free along its longitudinal axis Lx and movable relative to the rod 301. At the distal end of the manipulator, an adsorption unit 311 is provided, which has a flexible, non-invasive adsorption groove 306 that can establish contact with cylindrical tissue structures by means of negative pressure. The adsorption unit 311 is connected to the rod 301 and the push-pull rod 300 via articulation devices 302, 303, 304, and 305, allowing the angle 314 between the longitudinal axis Lx of the rod 301 and the adsorption unit 311 to be freely adjustable. This adjustable angle allows for the insertion of the cannula 310 and optimal contact with tissue structures. Inside the adsorption groove 306, there are multiple adsorption holes 307 connected to adsorption channels 312. The adsorption groove has a groove width 313. At the outlet of the adsorption channel 312, a vacuum interface 315 is provided, which is connected to an external vacuum pump to generate negative pressure inside the adsorption tank 306.

[0071] Figure 7 The electrode layout within the adsorption tank 306 and the controllability of the neuromodulation process are schematically illustrated. In electrode layout 1 (left side), there are two ablation and stimulation electrodes 316_1 and 316_2, and three measurement electrodes 317_1, 317_2, and 317_3. All electrodes are arranged perpendicular to the longitudinal axis of the adsorbed cylindrical tissue structure. Basic stimulation of the nerve can be initiated at the start of the process by applying a specific current to the two electrodes 316_1 and 316_2. Nerve conduction can be measured simultaneously with the three measurement electrodes 317_1, 317_2, and 317_3. For this purpose, two bipolar voltages are acquired and processed via electrode pairs 317_1 and 317_2 and electrode pairs 317_2 and 317_3. After the basic measurement, bipolar ablation is performed via electrode pairs 316_1 and 316_2. To characterize neuromodulation, nerve conduction is measured and analyzed again after ablation, as previously described. The process flow in electrode layout 2 (right side) is the same. However, the electrode arrangement within the adsorption tank 306 differs. In this configuration, all electrodes are arranged parallel to the longitudinal axis of the adsorbed cylindrical tissue structure. To the right of the multiple adsorption holes 307 are two ablation and stimulation electrodes 318_1 and 318_2, and to the left of the multiple adsorption holes 307 are measuring electrodes 319_1, 319_2, and 319_3.

[0072] Figure 8A modified embodiment of the distal portion of a laparoscopic manipulator is shown. This manipulator has an external rod 401, which can be introduced through a cannula 410 through the patient's torso. A first push-pull rod 400 is housed within the rod 401, freely movable along the longitudinal axis Lx. At the distal end of the manipulator is a two-part grasper with a first half-shell 406 and a second half-shell 407, each half-shell having a recess for clamping cylindrical tissue structures. To achieve the clamping mechanism, the two-part grasper is connected to the external rod 401 and the internal push-pull rod 400 via articulation devices 402, 403, 404, 405, 414, and 415, such that movement of the push-pull rod 400 along the longitudinal axis Lx results in clamping of the first half-shell 406 and the second half-shell 407. Therefore, the achieved clamping distance 408 is variablely adjustable to accommodate different tissue structures. A second push-pull rod 412 is provided inside the rod 401, which is connected to the first half-shell 406 and the second half-shell 407, allowing the angle 416 between the longitudinal axis Lx of the rod 401 and the two half-shell grippers to be adjusted. This adjustable angle 416 enables the insertion of the cannula needle 410 and achieves optimal contact with the tissue structure. Multiple ablation and stimulation electrodes 420_n and measuring electrodes 421_m are provided in the recesses of the first half-shell 406 and the second half-shell 407, each connected to an analysis and control unit and a generator system (not shown) via electrical connections located inside the rod 401. These electrodes are exposed to the external environment, while the electrical connections to the control unit and generator system are isolated from the external environment. Taking two ablation and stimulation electrodes and three measuring electrodes as an example, the control method is similar to... Figure 7 The descriptions are similar to those in the text.

[0073] Figure 9 Another embodiment of the distal portion of a laparoscopic manipulator is shown. The manipulator has an external rod 601, which can be introduced through a cannula 610 through the patient's torso. Within the rod 601 is a capture structure, such as a capture basket, made of shape memory material, consisting of three associated racks 604 and two independent racks 602 and 603. The entire capture structure is elastic and can be fully retracted into the rod 601. It is designed to clamp and wrap around cylindrical tissue structures in the state shown in the figure. On each of the three associated racks 604 are multiple stimulation and ablation electrodes 605_n and multiple measurement electrodes 606_m. Each electrode 605_n, 606_m is connected to an analysis and control unit and a signal generator system (all not shown) via electrical connections located within the rod 601. The electrodes are exposed to the external environment, while the electrical connections to the analysis and control unit and the generator system are isolated from the external environment. Taking two ablation and stimulation electrodes and three measurement electrodes as an example, the control method is similar to... Figure 7 The descriptions are similar to those in the text.

[0074] Figure 10 The procedure for performing laparoscopic neuromodulation is illustrated using the denervation process as an example. Figure 10 One or more of the steps shown can be performed using a laparoscopic manipulator, such as... Figure 4 , Figure 6 , Figure 8 and Figure 9 The manipulator described herein. In the first step 501, the manipulator system, particularly the laparoscopic manipulator, is inserted into the patient via laparoscopic surgery. As in Figure 4 , Figure 6 , Figure 8 and Figure 10 As illustrated in the example, the laparoscopic manipulator may have a cannula through which the manipulator's rod can be inserted into the patient's torso. After the manipulator is positioned, the local impedance of the ablation electrodes is measured to check whether they have sufficient contact with the tissue (step 502). In the next step 503, the starting value of nerve conduction (Ausgangswert) is recorded, for example, by means of the above... Figure 7 The mechanism described herein. For example, a stimulation pulse can be delivered to one or more nerves by applying a defined current to electrodes located distal or proximal to the ablation electrode. In the case of simultaneous stimulation, the bipolar voltage generated on the measuring electrode pair is measured and used to characterize nerve conduction. Subsequently, in step 504, a choice can be made between two procedures or input options: denervation by pulsed field ablation (PFA) or a combined procedure of PFA and RF energy. If PFA denervation is selected (step 505), the procedure, particularly the energy release, will be determined according to... Figure 2 The exemplary protocol shown is performed via biphasic IRE pulses. If a combined process of PFA and RF energy is selected (step 506), the process, particularly the energy release, will be based on... Figure 3 The exemplary combination protocol shown is performed. Regardless of the deneuronization method chosen, neural activity is recorded again (step 507) to characterize the deneuronization (step 508), as in... Figure 7 , Figure 8 and Figure 9 As described in [the text].

[0075] In addition to the advantageous manipulator, this paper describes a laparoscopic-based neuromodulation procedure using a combination of sequential IRE and radiofrequency (RF) sequences. This allows for targeted enhancement of tissue conductivity under continuous temperature monitoring. This maximizes the success rate of irreversible electroporation while minimizing potentially harmful high current densities. Furthermore, the manipulator eliminates the need for ablation across the vessel wall.

Claims

1. A device for use in laparoscopic surgery, comprising: - A rod with a distal end and a proximal end; - A holding unit, which is disposed at the distal end of the rod and is used to hold and / or release tissue; -At least two electrodes integrated in the holding unit; - A force transmission unit, which is disposed on the rod and connected to the retaining unit, is used to move relative to the rod; - An electrical conductor disposed within the rod and connected to the at least two electrodes for transmitting electrical signals received through the proximal end of the rod to the at least two electrodes.

2. The device according to claim 1, comprising a joint device disposed between the retaining unit and the distal end of the rod for connecting the distal end of the rod and the retaining unit, particularly for movably connecting them, wherein, The movement of the force transmission unit causes the holding unit to move and / or holds and / or releases the tissue by means of the force transmission unit.

3. The apparatus according to claim 1 or 2, wherein, The retaining unit is designed as a finger gripper, especially a three-finger gripper, and the force transmission unit is designed as a push-pull rod, wherein the movement of the push-pull rod causes the finger gripper to open or close to clamp or release tissue.

4. The apparatus according to claim 3, wherein, The fingers of the finger gripper each have an inner surface facing the tissue, and especially when the finger gripper is closed, at least one of the at least two electrodes, and especially one of the plurality of electrodes, is integrated on the inner surface.

5. The apparatus according to claim 1 or 2, wherein, The holding unit is designed as an adsorption unit, wherein the movement of the force transmission unit causes the adsorption unit to tilt relative to the rod, and / or the adsorption unit is configured to adsorb the tissue or separate it from the tissue.

6. The apparatus according to claim 5, wherein, The adsorption unit has: - Adsorption tank; - At least one adsorption hole is provided in the adsorption tank; - An adsorption channel connected to the at least one adsorption pore; and / or - An adsorption interface is provided at one end of the adsorption channel. An external vacuum pump can be connected through the adsorption interface to generate negative pressure in the adsorption tank and adsorb the tissue onto the adsorption tank.

7. The apparatus according to claim 6, wherein, The adsorption tank is elliptical along the vertical axis, especially in the shape of a motion field or a circle, and the at least two electrodes are arranged in the adsorption tank along the vertical axis and / or transversely to the vertical axis.

8. The apparatus according to claim 6 or 7, wherein, The adsorption tank is elliptical along the vertical axis, especially in the shape of a sports field or a circle, and at least three electrodes are arranged in the adsorption tank along the vertical axis and / or transversely to the vertical axis, especially spaced apart from the at least two electrodes.

9. The apparatus according to claim 1 or 2, wherein, The holding unit is configured as a shell gripper, particularly a two-part shell gripper, wherein movement of the force transmission unit causes the shell gripper to tilt relative to the rod and / or to open and / or close the shell gripper.

10. The apparatus according to claim 9, wherein, The shell-type gripper extends along the horizontal axis and is configured to open or close along the vertical axis, wherein the at least two electrodes are integrated on the inside of at least one shell, particularly along the vertical axis.

11. The apparatus according to claim 9 or 10, wherein, The shell-type gripper extends along the horizontal axis and is configured to open or close along the vertical axis, wherein at least three electrodes are integrated on the inside of at least one shell, particularly along the vertical axis and / or transversely to the vertical axis, and spaced apart from the at least two electrodes.

12. The apparatus according to any one of claims 9 to 11, wherein, The force transmission unit is configured as a first push-pull rod, disposed within the rod and connected to the joint device, wherein movement of the first push-pull rod causes the shell gripper to open or close, and / or the force transmission unit is configured as a second push-pull rod, disposed within the rod and particularly connected only to the shell gripper, wherein movement of the second push-pull rod causes the shell gripper to tilt relative to the rod.

13. The apparatus according to any one of claims 1 to 12, wherein, The force transmission unit and the holding unit are configured as associated shape memory materials, particularly shape memory alloys, and the holding unit is configured as a capture structure, particularly a capture basket, wherein movement of the force transmission unit causes it to retract into the rod and the capture structure, particularly the capture basket, to fold, or causes it to move out of the rod and the capture structure, particularly the capture basket, to unfold.

14. The apparatus according to claim 13, wherein, The capture structure has two independent and three associated racks, wherein the at least two and / or at least three electrodes are integrated on these racks, particularly on the associated racks.

15. A system for laparoscopic ablation, comprising: - The apparatus according to any one of claims 1 to 14; -A signal generator device that is connected to or can be connected to the device; as well as - A control and analysis unit that is connected to or can be connected to the device and / or the signal generator device.

16. The system according to claim 15, wherein, The signal generator device has a first signal generator for generating radio frequency (RF) signals and a second signal generator for generating pulsed field ablation signals.

17. The system according to claim 15 or 16, wherein, The control and analysis unit is configured to control the first signal generator and / or the second signal generator to emit signals.

18. The system according to claim 17, wherein, The control and analysis unit is configured to control the first signal generator and / or the second signal generator to emit signals based on the temperature of at least one electrode.

19. The system according to claim 18, wherein, The control and analysis unit is configured to control the first signal generator to emit a signal when the electrode temperature is below the temperature boundary value, and to control the second signal generator to emit a signal when the electrode temperature is close to or exceeds the temperature boundary value.

20. The system according to any one of claims 15 to 19, wherein, The control and analysis unit is configured to apply current to at least two electrodes and / or measure voltage through at least three electrodes, wherein the neural activity of the tissue and / or the local tissue impedance can be determined from the current and the voltage.

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