Multi-electrode radiofrequency ablation equipment and control method thereof

Abstract

The invention relates to a multi-electrode radiofrequency ablation device and a control method thereof.The multi-electrode radiofrequency ablation device comprises a first electrode, a second electrode and a neutral electrode, and the first electrode, the second electrode and the neutral electrode form a first working mode and a second working mode; wherein in the first working mode, the first electrode serves as a radio frequency output source, the second electrode is grounded, and the neutral electrode is idle; in a second working mode, the first electrode and the second electrode serve as radio frequency output sources, and the neutral electrode is grounded; when radiofrequency ablation treatment is carried out, the first working mode and the second working mode periodically and alternately work, and the problem that the ablation range of a traditional method is limited is solved through the periodically-alternate working modes.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multi-electrode radiofrequency ablation device and its control method. Background Technology

[0002] Bipolar radiofrequency ablation is a minimally invasive tumor ablation treatment technique that uses the heat generated by radiofrequency current to precisely destroy (ablate) tumor tissue. In existing bipolar radiofrequency ablation treatments, the device typically controls the electrode output through the following three methods.

[0003] 1. Alternating output mode: For example, first ablate with electrode A at 50W power for 5 minutes, and then ablate with electrode B at 40W power for 5 minutes. Although this method avoids energy overload, because the two electrodes work independently and do not utilize the synergistic heat transfer effect, the ablation range is only the sum of the effects of a single electrode, and the total treatment time is long (e.g., 10 minutes), resulting in low efficiency in tissue thermal damage.

[0004] II. Simultaneous Output Mode: For example, electrodes A and B are used as RF output sources to simultaneously output a total power of 100W. Due to the small potential difference between the two electrodes (because of the same polarity output), the heating rate of the central region is slow.

[0005] III. Unipolar Loop Mode: In this mode, electrode A serves as the RF output source, and electrode B is grounded. Because a closed loop is formed between the two electrodes, energy is concentrated in the central region of the two electrodes, while the outer region heats up slowly.

[0006] Existing methods cannot achieve a balance between ablation efficiency, uniformity of treatment area, and treatment duration. There is an urgent need for a control method that can dynamically combine the advantages of different modes. Summary of the Invention

[0007] The purpose of this invention is to provide a control method for a multi-electrode radiofrequency ablation device, which solves the problem of limited ablation range in traditional methods by using a periodically alternating working mode.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0009] A control method for a multi-electrode radiofrequency ablation device, the multi-electrode radiofrequency ablation device comprising a first electrode, a second electrode, and a neutral electrode, wherein the first electrode, the second electrode, and the neutral electrode constitute a first operating mode and a second operating mode; wherein...

[0010] In the first operating mode, the first electrode serves as the radio frequency output source, the second electrode is grounded, and the neutral electrode is idle;

[0011] In the second operating mode, both the first electrode and the second electrode serve as radio frequency output sources, and the neutral electrode is grounded;

[0012] During radiofrequency ablation treatment, the first working mode and the second working mode alternate periodically.

[0013] In one embodiment, the switching between the first working mode and the second working mode is performed by setting a time interval.

[0014] In one embodiment, the switching between the first operating mode and the second operating mode is determined by the impedance value between the RF output source and the grounded electrode.

[0015] In one embodiment, the switching conditions between the first operating mode and the second operating mode include a set time and the impedance change value between the RF output source and the grounded electrode. When either condition is met, the operating mode is switched to the other.

[0016] In one embodiment, when the impedance between the radio frequency output source and the grounded electrode is greater than or equal to 1.2 times the initial impedance, the multi-electrode radio frequency ablation device switches to another operating mode.

[0017] In one embodiment, the switching time between the first working mode and the second working mode is 15-120 seconds.

[0018] In one embodiment, during radiofrequency ablation treatment, the first and second electrodes are inserted into the target area, and the neutral electrode is attached to the target tissue.

[0019] In one embodiment, the distance between the first electrode and the second electrode is 0.5-3.5 cm.

[0020] In one embodiment, both the first electrode and the second electrode are provided with a cooling system.

[0021] The present invention also provides a multi-electrode radiofrequency ablation device, which includes a first electrode, a second electrode and a neutral electrode, and the working mode of the multi-electrode radiofrequency ablation device is controlled by any of the control methods described above.

[0022] The present invention employs the above-mentioned technical solution, and its beneficial effects are as follows: The control method of the present invention performs radiofrequency ablation treatment by periodically alternating between two modes, a first working mode and a second working mode. By utilizing the complementarity of the electric field distribution of the two modes, a larger effective ablation range can be achieved in the same time period than a single mode, thus solving the problem of limited ablation range in traditional methods. The control method can also optimize the uniformity of radiofrequency ablation heating, making the heat field distribution more uniform and avoiding the "dumbbell-shaped" defect in the middle area of ​​traditional methods. It achieves uniform heat distribution with efficient heating in the center and sufficient ablation at the edges, reducing the possibility of incomplete ablation. Attached Figure Description

[0023] Figure 1 The thermal field distribution of the electrode in the second operating mode is shown.

[0024] Figure 2 The thermal field distribution of the electrode in the first operating mode is shown.

[0025] Figure 3 The thermal field distribution of the electrode is shown under the periodic alternation of the first and second working modes. Detailed Implementation

[0026] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings to provide a clearer understanding of the purpose, features, and advantages of the present invention. It should be understood that the embodiments shown in the drawings are not intended to limit the scope of the present invention, but are merely illustrative of the essential spirit of the technical solution of the present invention.

[0027] In the following description, certain specific details are set forth for the purpose of illustrating various disclosed embodiments in order to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the art will recognize that embodiments may be practiced without one or more of these specific details. In other instances, well-known apparatuses, structures, and techniques associated with this application may not have been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0028] Unless the context requires otherwise, throughout the specification and claims, the word “comprising” and its variations, such as “including” and “having”, shall be understood to have an open, inclusive meaning, that is, to be interpreted as “including, but not limited to”.

[0029] Throughout this specification, references to "an embodiment" or "an embodiment" indicate that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Therefore, the appearance of "in an embodiment" or "an embodiment" in various places throughout the specification does not necessarily refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic may be combined in any manner in one or more embodiments.

[0030] The singular forms “a” and “the” used in this specification and the appended claims include plural references unless otherwise expressly stated herein. It should be noted that the term “or” is generally used to mean “and / or” unless otherwise expressly stated herein.

[0031] In the following description, in order to clearly demonstrate the structure and working method of the present invention, a number of directional terms will be used. However, terms such as "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", and "down" should be understood as convenient terms and not as limiting terms.

[0032] Furthermore, terms such as "horizontal," "vertical," and "sag" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0033] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0034] This invention provides a multi-electrode radiofrequency ablation device and its control method. The multi-electrode radiofrequency ablation device includes a first electrode, a second electrode, and a neutral electrode, which constitute two operating modes. In the first operating mode, the first electrode acts as a radiofrequency output source, the second electrode is grounded, and the neutral electrode is idle. In the second operating mode, both the first and second electrodes act as radiofrequency output sources simultaneously, with the neutral electrode grounded. Before performing radiofrequency ablation treatment, the first and second electrodes are inserted into the target area, with the distance between the first and second electrodes controlled between 1.5 cm and 3 cm. The neutral electrode is attached to the target tissue.

[0035] During radiofrequency ablation treatment, the first and second working modes alternate periodically. For example, the first working mode is used for a set time, then the second working mode is used for a set time after the first working mode ends, and so on until the radiofrequency ablation treatment is completed. Alternatively, in actual treatment, the second working mode can be used first, followed by the first working mode, and so on until the radiofrequency ablation treatment is completed. This invention's control method uses the periodic alternation of the first and second working modes for radiofrequency ablation treatment. By utilizing the complementarity of the electric field distributions of the two modes, a larger effective ablation range can be achieved within the same time frame compared to a single mode, solving the problem of limited ablation range in traditional methods.

[0036] In this invention, switching between the two operating modes can be achieved by setting a time interval, or by monitoring the impedance between the RF output source and the neutral electrode. When the detected impedance increase reaches a set value, the system switches to the other operating mode. Alternatively, switching between the two operating modes can be achieved simultaneously by setting a time interval and monitoring the impedance change between the RF output source and the neutral electrode; that is, the system switches to the other operating mode when one condition is met.

[0037] The switching process based on impedance changes is as follows: In the first working mode, the first electrode and the second electrode output simultaneously as radiofrequency output sources. The impedance between the first electrode, the second electrode and the neutral electrode is monitored. When the impedance increase reaches the set value (e.g., the impedance is higher than 1.2 times the initial impedance), it indicates that the maximum ablation range has been approached in this working mode. Therefore, the second working mode is switched to perform radiofrequency ablation treatment.

[0038] In the second working mode, the first electrode is used as the radiofrequency output source and the second electrode is grounded. Therefore, the impedance between the first and second electrodes is monitored. When the impedance increase reaches the set value (e.g., the impedance is higher than 1.2 times the initial impedance), it indicates that the maximum ablation range has been approached in this working mode. Therefore, the system is switched back to the first working mode for radiofrequency ablation treatment.

[0039] The above control method can optimize the uniformity of radiofrequency ablation heating, making the heat field distribution more uniform, avoiding the "dumbbell-shaped" defect in the middle area of ​​the traditional solution, achieving a uniform heat distribution with efficient heating in the center and full ablation at the edges, and reducing the possibility of incomplete ablation.

[0040] Since the first and second electrodes serve as radiofrequency output sources, the tissue needs to be conductive during the radiofrequency process. However, the temperature around the probe is highest during the radiofrequency process, and the surrounding tissue is prone to dehydration and carbonization, potentially forcing treatment interruption. Therefore, cooling is required inside the first and second electrodes. A cooling system is thus installed inside the first and second electrodes to maintain their set temperatures. In this embodiment, the cooling system is a low-temperature nitrogen cooling system.

[0041] Example

[0042] This embodiment performs radiofrequency ablation treatment under the following conditions. Before radiofrequency ablation treatment, the first electrode and the second electrode are inserted into the target area with a distance of about 3 cm between them. The internal cooling systems of the first electrode and the second electrode are turned on throughout the radiofrequency process, and the neutral electrode is attached to the target tissue.

[0043] In the first operating mode, the first electrode serves as the RF output source, the second electrode is grounded, and the output power is 50W. In the second operating mode, the first and second electrodes serve as RF output sources simultaneously, the neutral electrode is grounded, and the output power is 70W.

[0044] The switching interval between working modes is set to 30 seconds, and the impedance change switching setting is higher than 1.2 times the initial impedance. First, radiofrequency ablation treatment is performed in the first working mode. When the first working mode lasts for 30 seconds or the impedance is higher than 1.2 times the initial impedance of the first working mode, the ground is connected to the neutral electrode through a relay, and the first and second electrodes are both connected to the radiofrequency output source. At this time, the treatment is switched to the second working mode for radiofrequency ablation.

[0045] When the second working mode lasts for 30 seconds or the impedance is higher than 1.2 times the initial impedance of the second working mode, the ground is connected to the second electrode via a relay, and the first electrode is connected to the radiofrequency output source. At this time, the system switches to the first working mode for radiofrequency ablation treatment. This cycle is repeated for 10 minutes to complete the radiofrequency ablation treatment.

[0046] See Figures 1-3 , Figure 1 The thermal field distribution diagram of the electrode in the second operating mode is shown. Figure 1 As can be seen, in the second working mode alone, the heating rate of the central area between the two electrodes is slow, making it difficult to perform ablation treatment on the central area. Figure 2 The thermal field distribution diagram of the electrode in the first operating mode is shown. Figure 2 As can be seen, in the first working mode alone, the energy is concentrated in the central region between the two electrodes, making it difficult to achieve sufficient ablation of the edge regions of the electrodes. Figure 3The diagram shows the thermal field distribution of the electrodes under the periodic alternation of the first and second operating modes. Figure 3 As can be seen, the periodic alternation of the two working modes achieves a more uniform heat distribution. After radiofrequency ablation treatment, observation of the target tissue revealed extensive coagulative necrosis between and on the outer side of the two electrodes, indicating that the scheme in this embodiment can achieve good ablation treatment.

[0047] The preferred embodiments of the present invention have been described in detail above. However, it should be understood that after reading the above teachings, those skilled in the art can make various alterations or modifications to the present invention. These equivalent forms also fall within the scope defined by the appended claims.

Claims

1. A control method for a multi-electrode radiofrequency ablation device, characterized in that, The multi-electrode radiofrequency ablation device includes a first electrode, a second electrode, and a neutral electrode, wherein the first electrode, the second electrode, and the neutral electrode constitute a first operating mode and a second operating mode; wherein... In the first operating mode, the first electrode serves as the radio frequency output source, the second electrode is grounded, and the neutral electrode is idle; In the second operating mode, both the first electrode and the second electrode serve as radio frequency output sources, and the neutral electrode is grounded; During radiofrequency ablation treatment, the first working mode and the second working mode alternate periodically.

2. The control method as described in claim 1, characterized in that, The switching between the first working mode and the second working mode is achieved by setting a time interval.

3. The control method as described in claim 1, characterized in that, The switching between the first operating mode and the second operating mode is determined by the impedance value between the RF output source and the grounded electrode.

4. The control method as described in claim 3, characterized in that, The switching conditions between the first working mode and the second working mode include the set time and the impedance change value between the RF output source and the grounded electrode. When either condition is met, the other working mode is switched.

5. The control method as described in claim 3 or 4, characterized in that, When the impedance between the RF output source and the grounded electrode is greater than or equal to 1.2 times the initial impedance, the multi-electrode RF ablation device switches to another operating mode.

6. The control method as described in claim 2 or 4, characterized in that, The switching time between the first working mode and the second working mode is 15-120 seconds.

7. The control method as described in claim 1, characterized in that, During radiofrequency ablation treatment, the first and second electrodes are inserted into the target area, and the neutral electrode is attached to the target tissue.

8. The control method as described in claim 7, characterized in that, The distance between the first electrode and the second electrode is 0.5-3.5 cm.

9. The control method as described in claim 1, characterized in that, Both the first electrode and the second electrode are equipped with cooling systems.

10. A multi-electrode radiofrequency ablation device, characterized in that, The multi-electrode radiofrequency ablation device includes a first electrode, a second electrode, and a neutral electrode, and the operating mode of the multi-electrode radiofrequency ablation device is controlled by the control method described in any one of claims 1 to 9.

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