WO2026018191A1

WO2026018191A1 - Bipolar radio frequency electrosurgical device

Info

Publication number: WO2026018191A1
Application number: PCT/IB2025/057242
Authority: WO
Inventors: Giulia DI CAPUA; Renato PATRONE
Original assignee: Kylix Srl
Current assignee: Kylix Srl
Priority date: 2024-07-18
Filing date: 2025-07-17
Publication date: 2026-01-22
Anticipated expiration: 2027-01-18

Abstract

The bipolar radio frequency electrosurgical device (1) comprises: - at least one manipulation body (2); - at least one insertion element (3) having a substantially elongated conformation, provided with a proximal end (4), associated with the manipulation body (2), and with a distal end (5), which can be positioned in contact with a body tissue of a patient; - at least two electrodes (6) associated with the insertion element (3) where the distal end (5) is located and adapted to deliver, where the body tissue is located, a bipolar radio frequency electric current generated by an external generating unit; wherein the insertion element (3) is made, at least partly, of a substantially flexible material.

Description

BIPOLAR RADIO FREQUENCY ELECTROSURGICAL DEVICE

Technical Field

The present invention relates to a bipolar radio frequency electrosurgical device. Background Art

In the medical field, the surgical ablation technique is very widespread, which involves necrotizing the body tissue through thermal treatment, which can be of the heating or cryogenic type.

Heating ablation treatments involve targeting the body tissue to be treated with high-temperature thermal energy in order to achieve thermocoagulation of the same tissue, which then necrotizes.

Heat ablation can be performed using various techniques and, in this disclosure, bipolar radio frequency ablation will be referred to, which involves targeting the body tissue with high-frequency electrical current.

Bipolar radio frequency ablation surgery is becoming increasingly widespread in surgical cancer treatments, particularly those involving the liver, in which electrical discharges are delivered to cancer cells, killing them without damaging adjacent vital structures.

To perform bipolar radio frequency ablation surgery, bipolar radio frequency electrosurgical devices are commonly used. These generally comprise a handpiece, which is held by a user, and a needle element, which is associated with the handpiece and inserted into the patient’s body under ultrasound guidance, by placing the tip at the point where the body tissue to be treated is located.

These devices also comprise two electrodes which are associated with the tip of the needle element and which deliver a high-frequency electric current produced by a relevant generator where the body tissue is located.

In recent years, there has been an increasing use of minimally invasive surgery, such as laparoscopic surgery and robotic surgery, because they have less impact on the patient, require a shorter post-surgery recovery period and because they allow for faster recovery than open surgery.

Bipolar radio frequency electrosurgical devices of known type cannot, however, always be used practically and easily during minimally invasive surgery performed with ablative techniques.

In this regard, it should be noted that, in the case of laparoscopic surgery, it is difficult for the surgeon to handle a rigid needle element.

This is a consequence of the presence of a double fulcrum in the movement of the needle: the abdominal wall (1^st fulcrum) and the target organ (2^nd fulcrum), separated from each other by the presence of air (pneumoperitoneum).

In addition, the surgeon must manage the direct view of the patient, the view inside the abdomen (via a camera for minimally invasive access) and the ultrasound image.

These operating methods therefore seem very complex, due to the need to operate simultaneously on several fronts and the difficulty in manipulating the needle element.

In robotic surgery, the surgeon in charge of the operation is often positioned at the robot’s command console and is therefore unable to check that the ablative surgery is being performed correctly, which is why robotic surgery of the ablative type is almost never performed.

Added to this is the fact that, during the delivery of electrical current, the treated body tissue may become dehydrated and/or carbonized, conditions that can increase tissue impedance to the flow of electrical current, with a consequent progressive decrease in the efficiency of the operation.

To overcome this, in addition to using auxiliary instruments that measure the temperature and impedance at the tissue level, the tissue itself is irrigated with a physiological solution that can reduce the degree of dehydration and/or carbonization.

Furthermore, in order to improve the efficiency of the operation, it may be necessary to instill pharmacological solutions, such as chemotherapy or alcohol in nature, into the body tissue to be treated.

The instillation of physiological and/or pharmacological solutions is carried out through special delivery channels which are positioned in the patient’s body simultaneously with the bipolar radio frequency ablation.

This further complicates the surgical procedure because, in addition to the handling operations described above, the surgeon has to simultaneously position and handle the delivery channel for the physiological and/or pharmacological solutions.

Description of the Invention

The main aim of the present invention is to devise a bipolar radio frequency electrosurgical device which allows improving and simplifying surgery performed using the radio frequency ablation technique.

Within the scope of this aim, the present invention aims to devise a bipolar radio frequency electrosurgical device which allows minimally invasive surgery to be performed, in particular those performed laparoscopically or with the aid of surgical robots, using the radio frequency ablation technique.

Another object of the present invention is to devise a bipolar radio frequency electrosurgical device which allows simplifying the performance of procedures which are ancillary to surgery, such as the instillation of physiological and/or pharmacological solutions.

Furthermore, a further object of the present invention is to devise a bipolar radio frequency electrosurgical device which can be easily used during surgery employing an endoscope.

Another object of the present invention is to devise a bipolar radio frequency electrosurgical device which allows the aforementioned drawbacks of the prior art to be overcome in a simple, rational, easy and effective to use, as well as affordable solution.

The aforementioned objects are achieved by this bipolar radio frequency electrosurgical device having the characteristics of claim 1.

Brief Description of the Drawings

Other characteristics and advantages of the present invention will become more apparent from the description of a preferred, but not exclusive, embodiment of a bipolar radio frequency electrosurgical device, illustrated by way of an indicative, yet non-limiting example in the accompanying drawings, in which:

Figure 1 is an axonometric view of a bipolar radio frequency electrosurgical device according to the invention; Figure 2 and Figure 3 are partly exploded and partly enlarged axonometric views of some components of the bipolar radio frequency electrosurgical device according to the invention;

Figure 4 is a cross-sectional view of some components of the bipolar radio frequency electrosurgical device according to the invention.

Embodiments of the Invention

With particular reference to these figures, reference numeral 1 globally denotes a bipolar radio frequency electrosurgical device.

The electrosurgical device 1 comprises: at least one manipulation body 2; at least one insertion element 3 having a substantially elongated conformation, provided with a proximal end 4, associated with the manipulation body 2, and with a distal end 5, which can be positioned in contact with a body tissue of a patient; at least two electrodes 6 associated with the insertion element 3 where the distal end 5 is located and adapted to deliver, where the body tissue is located, a bipolar radio frequency electric current generated by an external generating unit.

In this disclosure, the terms “distal” and “proximal” and those derived therefrom must be interpreted with reference to an operator who manipulates the electrosurgical device 1 by grasping it directly or using surgical forceps where the manipulation body 2 is located.

As can be seen in Figure 2, the manipulation body 2 is substantially hollow and internally defines a housing compartment wherein the insertion element 3 is partly positioned.

More specifically, the proximal end 4 is inserted within the housing compartment. The manipulation body 2 defines a hole 7 through which the insertion element 3 protrudes from the housing compartment.

With reference to the particular embodiment shown in the figures, the manipulation body 2 comprises at least a first shell element 8 and at least a second shell element 9 which are mutually associated along their respective junction edges to define the housing compartment and to bound the hole 7.

The external generating unit is not shown in the figures and is of the type known to those skilled in the art.

The external generating unit is, e.g. of the type of a current generator configured to generate a bipolar radio frequency electric current.

Usefully, the electrosurgical device 1 comprises on/off means configured to allow/prevent the electric current from flowing from the external generating unit to the electrodes 6.

The on/off means are not shown in the figures for sake of simplicity only but are of a type known to those skilled in the art.

Each electrode 6 is connected to the external generating unit with bipolar radio frequency electric current in a maimer that will be described in detail below.

During use of the electrosurgical device 1, an operator holds the manipulation body 2 and inserts the insertion element 3 into the body of a patient, positioning the distal end 5 directly in contact with the body tissue to be treated.

When the distal end 5 is correctly positioned at the body tissue, the operator activates the external generating unit by operating the on/off means, thereby electrically charging the electrodes 6, which can then deliver a bipolar radio frequency electrical discharge where the body tissue to be necrotized is located. The duration of the electrical current delivery may vary, e.g., depending on the extension and depth of the tissue to be necrotized and/or depending on the biological characteristics of the tissue itself.

According to the invention, the insertion element 3 is at least partly made of a substantially flexible material.

This particular technical expedient allows facilitating and simplifying the insertion of the insertion element 3 within the patient’s body and the placement of the distal end 5 where the body tissue to be treated is located.

In detail, the fact of having a substantially flexible insertion element 3 makes it easier and more convenient for the surgeon to manipulate the electrosurgical device 1 in the patient’s body, thus overcoming the problem of the two fulcrums. Furthermore, the fact that the insertion element 3 is substantially flexible allows the electrosurgical device 1 to be used during laparoscopic surgery, as it can be easily maneuvered by a surgeon who can also maneuver any intraoperative ultrasound probe, thus having full control of the surgical operation on several fronts.

Furthermore, thanks to the particular nature of the insertion element 3, it is possible to maneuver the same insertion element 3 also by means of laparoscopic surgical forceps or robotic surgical forceps.

Furthermore, the fact that the insertion element 3 is made of a substantially flexible material allows the insertion element itself 3 to be inserted within an operational channel of an endoscope, thus allowing surgery with radio frequency ablation technique to be performed even in inoperable patients.

Usefully, the insertion element 3 is made of an electrically insulating material.

This particular technical expedient prevents the insertion element 3 from becoming electrically charged when the external generating unit is activated. Advantageously, the electrodes 6 are made of an electrically conductive material. For example, the electrodes 6 are made of stainless steel.

According to the preferred embodiment shown in the figures, the distal end 5 is substantially pointed.

According to an alternative embodiment of the electrosurgical device 1, not shown in the figures, the distal end 5 is substantially rounded.

This latter embodiment is very advantageous in the event of the insertion element 3 being inserted into the operational channel of an endoscope, since the substantially rounded distal end 5 does not graze and/or tear the operational channel itself.

Advantageously, the insertion element 3 comprises: at least a first portion 10 comprising the proximal end 4 and made, at least partly, of a substantially flexible material; and at least a second portion 11 associated with the first portion 10, comprising the distal end 5 and made, at least partly, of a substantially rigid material, the electrodes 6 being associated with the second portion 11.

For example, the substantially rigid material is Teflon. The length of the first portion 10 is comprised between 50 cm and 60 cm, preferably between 52 cm and 58 cm, more preferably between 54 cm and 56 cm. The length of the second portion 11 is comprised between 4.5 cm and 5.5 cm, preferably between 4.7 cm and 5.3 cm, more preferably between 4.9 cm and 5.1 cm.

According to one possible embodiment of the electrosurgical device 1, the first portion 10 has a length substantially equal to 60 cm and the second portion 11 has a length substantially equal to 5 cm.

In other words, the insertion element 3 is essentially and predominantly made of a substantially flexible material in order to make the insertion element 3 easy to maneuver.

At the same time, the insertion element 3 is made, where the distal end 5 is located, of a substantially rigid material so as to facilitate the positioning and maintenance of the distal end 5 and of the electrodes 6 on the body tissue to be treated.

Usefully, the insertion element 3 has a substantially tubular conformation and internally defines at least one channel 12, adapted to allow the flow of at least one working liquid.

Advantageously, the insertion element 3 comprises at least a first port 13, adapted to allow the inlet of the working liquid within the channel 12, and at least a second port 14, adapted to allow the outflow of the working liquid from the channel 12 where the body tissue to be treated is located.

The working liquid is, e.g., of the type of a physiological solution that is instilled where the tissue being treated is located in order to keep it hydrated and to limit carbonization caused by exposure to the electric current.

Alternately and/or in combination thereof, the working liquid is, e.g., of the type of a pharmacological solution which is instilled where the tissue being treated is located in order to perform a pharmacological treatment simultaneously with the radio frequency ablation treatment.

For example, the pharmacological solution is of the chemotherapeutic type.

The fact that the working liquid is delivered through the same insertion element 3 allows simplifying the surgeon’s operation, as they do not have to maneuver a working liquid delivery channel as is currently the case.

Usefully, the second port 14 is made where the distal end 5 is located.

This allows the working liquid to be delivered directly to the body tissue to be treated.

With particular reference to the preferred embodiment shown in the figures, the insertion element 3 comprises two second ports 14, each of which is formed where a respective electrode 6 is located.

This allows the working liquid to be delivered in the proximity of the point where each electrode 6 delivers the electrical discharge.

With particular reference to the preferred embodiment shown in the figures, the electrodes 6 have a substantially tubular conformation and are externally and coaxially associated with the second portion 11.

Usefully, the electrodes 6 are spaced apart from each other and the second ports 14 are positioned between the electrodes 6.

Preferably, the first port 13 is made where the proximal end 4 is located, the channel 12 extending substantially by the entire length of the insertion element 3. Usefully, the electrosurgical device 1 comprises fluid-operated connecting means 15, 16 adapted to transfer the working liquid from an external supply source of the working liquid to the first port 13.

As can be seen in Figure 2, the fluid-operated connecting means 15, 16 comprise at least one transfer duct 15, connected at one end to the first port 13 and at the other end to the external supply source of the working liquid.

Preferably, the fluid-operated connecting means 15, 16 comprise at least one connecting element 16 of the needle-free type.

Preferably, the connecting element 16 is of the Luer lock type.

The connecting element 16 is associated with the transfer duct 15 on the opposite side from the first port 13 and is adapted to connect the transfer duct 15 itself to the external supply source of the working liquid.

Preferably, the transfer duct 15 is at least partly housed within the housing compartment and protrudes from the latter in order to be connected to the external supply source of the working liquid.

Usefully, the first shell element 8 and the second shell element 9 define a mouth 17, the transfer duct 15 protruding from the housing compartment through the mouth 17.

The connecting element 16 is positioned outside the housing compartment so as to be accessible by an operator who can connect or disconnect the channel 12 to the external supply source of the working liquid as required.

Usefully, the electrosurgical device 1 comprises electrical connecting means 18, 19 adapted to transfer the radio frequency electric current from the external generating unit to the electrodes 6.

As can be seen in Figure 2 and Figure 3, the electrical connecting means 18, 19 comprise two electrical connecting cables 18, each of which is electrically connected to a respective electrode 6, and an electrical connector 19, adapted to connect the electrical connecting cables 18 to the external generating unit.

Preferably, the electrical connecting cables 18 are at least partly housed within the housing compartment.

Preferably, the electrical connector 19 is at least partly housed within the housing compartment and protrudes from the latter in order to connect to the external generating unit.

The electrical connector 19 is positioned outside the housing compartment so as to be accessible by an operator who can connect or disconnect the electrodes 6 to the external generating unit, as required.

Usefully, the first shell element 8 and the second shell element 9 define one opening 23, the electrical connector 19 protruding from the housing compartment through the opening 23.

Advantageously, the insertion element 3 internally defines at least one housing seat 20 adapted to at least partly contain the electrical connecting means 18, 19. Specifically, the electrical connecting cables 18 are partly housed within the housing seat 20.

Usefully, and as can be seen in Figure 4, the housing seat 20 is distinct and separate from the channel 12. In this way, there is no contact between the electrical connecting cables 18, which carry electric current, and the water-based working liquid, thus limiting the risk of short circuits, which could damage the electrosurgical device 1 and/or the external generating unit connected thereto.

With reference to the preferred embodiment shown in the figures, the insertion element 3 comprises: at least one external wall 21 having a substantially tubular shape and externally bounding the channel 12 and the housing seat 20; at least one internal wall 22 internally associated with the external wall 21 and adapted to separate the channel 12 from the housing seat 20.

It has in practice been ascertained that the described invention achieves the intended objects and, in particular, the fact should be emphasized that the electrosurgical device according to the invention is easy and convenient to maneuver, thanks to the flexibility of the insertion element.

This makes it possible to obtain a bipolar radio frequency electrosurgical device which allows improving and simplifying surgery performed using the radio frequency ablation technique.

The bipolar radio frequency electrosurgical device according to the invention also allows minimally invasive surgery to be performed, in particular laparoscopic surgery or surgery performed with the aid of surgical robots, using the radio frequency ablation technique.

Furthermore, due to the fact that the insertion element internally defines a channel for the flow of a working liquid, it is possible to simplify the performance of procedures which are ancillary to surgery itself, such as, e.g., the instillation of physiological solution and/or pharmacological solutions.

In addition, thanks to the flexibility of the insertion element, the electrosurgical device according to the invention can be used in surgery employing an endoscope, thus allowing surgery with radio frequency ablation technique to be performed even on patients who cannot be operated on.

Claims

1) Bipolar radio frequency electrosurgical device (1), comprising: at least one manipulation body (2); at least one insertion element (3) having a substantially elongated conformation, provided with a proximal end (4), associated with said manipulation body (2), and with a distal end (5), which can be positioned in contact with a body tissue of a patient; at least two electrodes (6) associated with said insertion element (3) where said distal end (5) is located and adapted to deliver, where said body tissue is located, a bipolar radio frequency electric current generated by an external generating unit; characterized by the fact that said insertion element (3) is made, at least partly, of a substantially flexible material.

2) Electrosurgical device (1) according to claim 1, characterized by the fact that said distal end (5) is substantially pointed.

3) Electrosurgical device (1) according to claim 1, characterized by the fact that said distal end (5) is substantially rounded.

4) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that: said insertion element (3) has a substantially tubular conformation and internally defines at least one channel (12) adapted to allow the transit of at least one working liquid; said insertion element (3) comprises at least a first port (13), adapted to allow the inlet of said working liquid within said channel (12), and at least a second port (14), adapted to allow the outflow of said working liquid from said channel (12) where said body tissue is located.

5) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that said second port (14) is made where said distal end (5) is located.

6) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that said first port (13) is made where said proximal end (4) is located, said channel (12) extending substantially by the entire length of said insertion element (3).

7) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that said insertion element (3) comprises: at least a first portion (10) comprising said proximal end (4) and made, at least partly, of said substantially flexible material; and at least a second portion (11) associated with said first portion (10), comprising said distal end (5) and made, at least partly, of a substantially rigid material, said electrodes (6) being associated with said second portion (11).

8) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that the length of said first portion (10) is comprised between 50 cm and 60 cm, preferably between 52 cm and 58 cm, more preferably between 54 cm and 56 cm, and by the fact that the length of said second portion (11) is comprised between 4.5 cm and 5.5 cm, preferably between 4.7 cm and 5.3 cm, more preferably between 4.9 cm and 5.1 cm.

9) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that said electrodes (6) have a substantially tubular conformation and are externally and coaxially associated with said second portion (11).

10) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that it comprises fluid-operated connecting means (15, 16) adapted to transfer said working liquid from an external source of supply of said working liquid to said first port (13), said fluid-operated connecting means (15, 16) comprising at least one connecting element (16) of the needle-free type.

11) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that it comprises electrical connecting means (18, 19) adapted to transfer said radio frequency electric current from said external generating unit to said electrodes (6).

12) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that said insertion element (3) internally defines at least one housing seat (20) adapted to contain at least partly said electrical connecting means (18, 19).

13) Electrosurgical device (1) according to one or more of the preceding claims, characterized by the fact that said housing seat (20) is distinct and separate from said channel (12).