A radiofrequency ablation device and a control method

Abstract

The present invention provides a radiofrequency ablation device and a control method. The radiofrequency ablation device includes: a catheter body; at least two electrodes, which are distributed at the first end of the catheter body, and any two of the at least two electrodes are insulated from each other; except for a first preset electrode among the at least two electrodes, the other electrodes are all electrically connected to at least one adjustment device. The at least one adjustment device is sleeved on the second end of the catheter body. At least one target electrode is selected from the other electrodes through the at least one adjustment device. The at least one target electrode and the first preset electrode form an electrode group, and the electrode group ablates the target tissue between the electrode groups according to the received radiofrequency signal. The target electrode is any one of the other electrodes. The solution of the present invention can achieve precise control of ablation areas at different positions, reduce the missed areas, and ensure complete ablation of the lesion area.

Description

Technical Field

[0001] The present invention relates to the field of radiofrequency ablation, and particularly to a radiofrequency ablation device and a control method thereof. Background Art

[0002] In the surgery for treating benign thyroid nodules, radiofrequency ablation technology has good curative effects. Radiofrequency ablation can effectively reduce the volume of thyroid nodules, relieve nodule-related symptoms and avoid surgical trauma. Compared with traditional surgeries, radiofrequency ablation has its own unique advantages in treating benign thyroid nodules, and its safety is acceptable. However, it should be noted that there are still complications such as recurrent laryngeal nerve injury, nodule rupture, bleeding, skin burns, etc. in this treatment.

[0003] In addition, for the treatment of primary liver cancer or metastatic liver cancer, for the treatment of primary renal cancer, for the treatment of lung cancer, for the treatment of diseases such as prostate tumors and hyperplasia, for the treatment of uterine fibroids, for primary bone tumors, etc., radiofrequency ablation has good treatment effects. However, for different diseased parts and different patients, the sizes of lesions are different. In radiofrequency treatment, a 5 - 10 mm safety margin needs to be established around the lesion to effectively treat the tumor and minimize the recurrence probability to the greatest extent.

[0004] The prior art can adjust the ablation volume by adjusting the power and action time. However, excessive increase in power or extension of time will cause the local temperature to be too high, resulting in tissue carbonization. Tissue carbonization will reduce the heat transfer efficiency. At the same time, the high temperature will also have an adverse impact on the surrounding tissues.

[0005] In actual surgical operations, doctors will perform multi-point ablation to treat lesions with a larger diameter. This increases the surgical steps and prolongs the operation time. At the same time, the ablation areas at different points cannot be accurately controlled, and there may be missed areas, unable to ensure the complete ablation of the lesion area. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a radiofrequency ablation device and a control method thereof, which can achieve accurate control of ablation areas at different points, reduce the occurrence of missed areas, and ensure the complete ablation of the lesion area.

[0007] To solve the above technical problem, the technical solution of the present invention is as follows:

[0008] A radiofrequency ablation device, comprising:

[0009] A catheter body;

[0010] At least two electrodes, the at least two electrodes are distributed at a first end of the catheter body, and any two of the at least two electrodes are insulated from each other;

[0011] Among the at least two electrodes, other electrodes except the first preset electrode are electrically connected to at least one adjusting device. The at least one adjusting device is sleeved on the second end of the catheter body. At least one target electrode is selected from the other electrodes through the at least one adjusting device. The at least one target electrode and the first preset electrode form an electrode group. The electrode group ablates the target tissue between the electrode group according to the received radio frequency signal. The target electrode is any one of the other electrodes.

[0012] Optionally, each electrode is electrically connected to a temperature monitoring device; the at least one adjusting device is electrically connected to a temperature monitoring device respectively. The adjusting device selects at least one target electrode from the other electrodes through the temperature monitoring device.

[0013] Optionally, the adjusting device includes: a first adjusting device. Through the first adjusting device, a first target electrode is selected from the other electrodes. The first target electrode and the first preset electrode form an electrode group. The first preset electrode is the positive electrode, and the first target electrode is the negative electrode. The first preset electrode and the first target electrode ablate the target tissue between the first preset electrode and the first target electrode according to the received radio frequency signal.

[0014] Optionally, the first adjusting device includes: a first wire connection component, and the first wire connection component is electrically connected to the temperature monitoring device of each electrode respectively;

[0015] A first adjusting knob in contact electrical connection with the first wire connection component. Through the first adjusting knob, the temperature monitoring device of the first target electrode is selected from the other electrodes, and is electrically connected to the first target electrode through the temperature monitoring device of the first target electrode.

[0016] Optionally, the first wire connection component is a first ring connector, and a first conduction interface of the temperature monitoring device is arranged on the first ring connector, and is electrically connected to the temperature monitoring device of the first target electrode through the first conduction interface.

[0017] Optionally, the adjusting device further includes: a second adjusting device. The second adjusting device is arranged side by side with the first adjusting device. Through the second adjusting device, a second target electrode is selected from the other electrodes. The second target electrode, the first target electrode and the first preset electrode form an electrode group. The first preset electrode is the positive electrode, the first target electrode is the negative electrode, the polarity of the second target electrode is the same as that of the first preset electrode, and the second target electrode and the first target electrode are different electrodes;

[0018] The first preset electrode, the first target electrode, and the second target electrode ablate the target tissue between the first preset electrode, the first target electrode, and the second target electrode according to the received radio frequency signal.

[0019] Optionally, the second adjusting device includes: a second wire connection assembly, and the second wire connection assembly is electrically connected to the temperature monitoring device of each electrode respectively;

[0020] A second adjusting knob in electrical contact connection with the second wire connection assembly, selecting the temperature monitoring device of the second target electrode among the other electrodes through the second adjusting knob, and being electrically connected to the second target electrode through the temperature monitoring device of the second target electrode.

[0021] Optionally, the second wire connection assembly is a second circular connecting piece, and a second conduction interface of the temperature monitoring device is arranged on the second circular connecting piece, and is electrically connected to the temperature monitoring device of the second target electrode through the second conduction interface.

[0022] Optionally, the radio frequency ablation device further includes: a gear indicating ring, the first adjusting knob and the second adjusting knob have pointers pointing to the gear indicating ring, and gear identifiers corresponding to each electrode are arranged on the gear indicating ring.

[0023] An embodiment of the present invention further provides a control method for a radio frequency ablation device, including:

[0024] Obtaining area information where the target tissue is located;

[0025] According to the area information, determining at least one target electrode among the other electrodes except the first preset electrode in at least two electrodes of the radio frequency ablation device, the at least one target electrode and the first preset electrode form an electrode group, and the target electrode is any one of the other electrodes;

[0026] Sending a radio frequency signal to the electrode group, so that the electrode group ablates the target tissue between the electrode group according to the received radio frequency signal.

[0027] The above solution of the present invention has at least the following beneficial effects:

[0028] In the above solution of the present invention, a catheter body is provided; and at least two electrodes, the at least two electrodes are evenly distributed at the first end of the catheter body, and any two of the at least two electrodes are insulated from each other; among the at least two electrodes, other electrodes except the first preset electrode are electrically connected to at least one adjusting device, the at least one adjusting device is sleeved on the second end of the catheter body, at least one target electrode is selected from the other electrodes through the at least one adjusting device, the at least one target electrode and the first preset electrode form an electrode group, and the electrode group ablates the target tissue between the electrode groups according to the received radio frequency signal, and the target electrode is any one of the other electrodes. Thus, precise control of the ablation areas at different points is achieved, the areas where omissions may occur are reduced, and complete ablation of the lesion area is ensured. Description of the Drawings

[0029] Figure 1 is a schematic diagram of the radiofrequency ablation device of the present invention;

[0030] Figure 2 is a connection diagram of the electrodes and the thermocouple of the radiofrequency ablation device of the present invention;

[0031] Figure 3 is a schematic diagram of the wire connection assembly of the radiofrequency ablation device of the present invention;

[0032] Figure 4 is a side view of the adjustment knob of the radiofrequency ablation device of the present invention;

[0033] Figure 5 is a schematic diagram of the adjustment knob of the radiofrequency ablation device of the present invention;

[0034] Figure 6 is a cross-sectional view of the adjustment knob of the radiofrequency ablation device of the present invention;

[0035] Figure 7 is a thermocouple lead diagram of the radiofrequency ablation device of the present invention;

[0036] Figure 8 is a flowchart of the control method of the radiofrequency ablation device of the present invention.

[0037] Description of the Reference Numerals:

[0038] 1 - Catheter body;

[0039] 21 - First electrode; 22 - Second electrode; 23 - Third electrode; 24 - Fourth electrode; 25 - Fifth electrode;

[0040] 31 - First thermocouple; 311 - First thermocouple negative electrode wire; 312 - First thermocouple positive electrode wire; 313 - Solder; 33 - Third thermocouple; 331 - Third thermocouple negative electrode wire; 332 - Third thermocouple positive electrode wire;

[0041] 4 - Insulating conduit;

[0042] 5 - First adjusting device; 51 - Gear position indicating ring; 52 - First knob pointer;

[0043] 53 - First wire connection assembly; 531 - First thermocouple negative contact; 532 - First thermocouple positive contact; 533 - Second thermocouple negative contact; 534 - Second thermocouple positive contact;

[0044] 54 - First adjusting knob; 541 - First adjusting knob positive contact; 542 - First adjusting knob negative contact; 543 - First adjusting knob negative ring; 544 - First adjusting knob positive ring;

[0045] 6 - Second adjusting device; 7 - Handle; 8 - Puncture needle channel; 9 - Integrated cable; 10 - Cable connector. Detailed implementation mode

[0046] Hereinafter, exemplary embodiments of the present disclosure will be described in more detail with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be fully conveyed to those skilled in the art.

[0047] As Figure 1 shown, an embodiment of the present invention provides a radiofrequency ablation device, including: a catheter body 1; at least two electrodes, the at least two electrodes being distributed at a first end of the catheter body 1, and any two of the at least two electrodes being insulated from each other; here, the at least two electrodes are spaced apart and distributed at the first end of the catheter body l, and the distance between adjacent two of the at least two electrodes can be the same or different;

[0048] All other electrodes except the first preset electrode among the at least two electrodes are electrically connected to at least one adjusting device, the at least one adjusting device is sleeved on a second end of the catheter body, at least one target electrode is selected from the other electrodes through the at least one adjusting device, the at least one target electrode and the first preset electrode form an electrode group, and the electrode group ablates the target tissue between the electrode group according to the received radiofrequency signal, and the target electrode is any one of the other electrodes.

[0049] In this embodiment, multiple electrodes are selected through multiple adjusting devices according to requirements, so as to achieve the excitation of two electrodes, three electrodes, or even multiple electrodes, thereby achieving different expected ablation lengths, ablation shapes, etc. In the face of lesions with different diameters or different shapes, the ablation area can cover the entire lesion, realizing precise control of the ablation areas at different points, reducing the omission areas, and ensuring complete ablation of the lesion area.

[0050] In this embodiment, five electrodes are arranged at intervals on the catheter body 1, namely the first electrode 21, the second electrode 22, the third electrode 23, and the fourth electrode 24, but it is not limited to five electrodes. Each electrode is insulated from each other by an insulating catheter 4, and the electrode spacing is 1 - 40 mm. In this embodiment, 10 mm is taken as an example. The intervals between the electrodes can be the same or different;

[0051] In this embodiment, the first electrode 21 at the tip of the catheter body 1 is set as the first preset electrode, which is defaulted to the positive electrode; of course, according to actual requirements, other electrodes can also be set as the first preset electrode; the electrodes selected by the adjusting device other than the first electrode are target electrodes;

[0052] In an alternative embodiment of the present invention, each electrode is electrically connected to a temperature monitoring device; the at least one adjusting device is electrically connected to a temperature monitoring device respectively, and the adjusting device selects at least one target electrode from the other electrodes through the temperature monitoring device.

[0053] Specifically, a temperature monitoring device is arranged inside each electrode, which can monitor the heating temperature of the electrode in real time. The catheter body 1 is also electrically connected to a radiofrequency energy generator. The radiofrequency energy generator judges whether to continue heating according to the monitored temperature value. If the temperature of any electrode exceeds the set value, the radiofrequency energy generator will stop heating to ensure the safety of the operation.

[0054] There are various choices for the temperature monitoring device. For example, a thermocouple is used as the temperature monitoring device. Each electrode is assembled with a temperature monitoring device, and the assembly method is welding or machining. Specifically, the welding or machining method should be able to conduct current. The positive wire of the thermocouple can also be used as the radiofrequency energy output wire of the electrode to deliver radiofrequency energy to the electrode. This method simplifies the structure of the radiofrequency ablation device, saves the number of cores of the cable, saves the space of the front-end catheter body part of the radiofrequency ablation device, and can make the catheter body more slender and flexible.

[0055] As Figure 2 shown, in this embodiment, the first electrode 21 and the first thermocouple 31 are welded together by solder 313, and the positive wire 312 of the first thermocouple is also welded to the first electrode 21 at the same time, which can provide radiofrequency output for the first electrode 21.

[0056] Similarly, the second electrode 22 is assembled with the second temperature monitoring device, the third electrode 23 is assembled with the third temperature monitoring device, the fourth electrode 24 is assembled with the fourth temperature monitoring device, and the fifth electrode is assembled with the fifth temperature monitoring device.

[0057] The positive and negative wires of each temperature monitoring device are connected to the adjusting device. The adjusting device selects at least one target electrode from the other electrodes through the temperature monitoring device. The positive wire of the temperature monitoring device can be used as the radio frequency energy output wire of the electrode.

[0058] As Figure 1 shown, in an optional embodiment of the present invention, the adjusting device includes: a first adjusting device 5, which selects a first target electrode from the other electrodes through the first adjusting device 5. The first target electrode and the first preset electrode form an electrode group. The first preset electrode is the positive electrode, and the first target electrode is the negative electrode. The first preset electrode and the first target electrode ablate the target tissue between the first preset electrode and the first target electrode according to the received radio frequency signal.

[0059] For example, the first target electrode is selected from the other electrodes through the first adjusting device 5. The first target electrode can be any one of the second electrode 22, the third electrode 23, the fourth electrode 24, and the fifth electrode 25. According to the indication of the first adjusting device 5, when it is in the first indication position, the first target electrode is the second electrode 22; when it is in the second indication position, the first target electrode is the third electrode 23. And so on. By adjusting the distance between the two electrodes through the first adjusting device, the expected target tissue site can be heated to remove the lesion. In this embodiment, the first target electrode is defined as the negative electrode.

[0060] In this embodiment, the first electrode 21 at the tip of the catheter body 1 of the radiofrequency ablation device is set as the first preset electrode, which is default as the positive electrode, and the other electrodes can be set as the positive electrode, the negative electrode, or the non-powered idle electrode according to needs. The adjusting device is used to control the connection or disconnection of the electrodes. For example, when the first preset electrode is set as the positive electrode and the first target electrode is set as the negative electrode, after loading the radio frequency signal emitted by the generator, a radio frequency current will be formed between the first preset electrode and the first target electrode. When the radio frequency current flows through the lesion tissue, due to the rapid change of the electromagnetic field, the polar water molecules in the lesion move at a high speed, generating an endogenous heat effect, causing the evaporation, drying, shrinkage and shedding of water inside and outside the cells, resulting in aseptic necrosis, so as to achieve the purpose of removing the lesion.

[0061] As Figure 1 、 Figure 3 、 Figure 4As shown in the figure, in an alternative embodiment of the present invention, the first adjustment device 5 includes:

[0062] A first wire connection assembly 53, and the first wire connection assembly 53 is electrically connected to the temperature monitoring device of each electrode respectively;

[0063] A first adjustment knob 54 in electrical contact with the first wire connection assembly 53, and the temperature monitoring device of the first target electrode among the other electrodes is selected through the first adjustment knob 54, and is electrically connected to the first target electrode through the temperature monitoring device of the first target electrode.

[0064] In this embodiment, the positive and negative wires of the five thermocouples corresponding to the five electrodes are connected to the first adjustment device 5 through the first wire connection assembly 53, so that the first adjustment device 5 can select and set different electrodes as the first target electrode.

[0065] Specifically, the negative wire of the first thermocouple is connected to the first negative contact 531 of the first wire connection assembly 53; the positive wire of the first thermocouple is connected to the first positive contact 532 of the first wire connection assembly 53;

[0066] And so on, the negative wire of the second thermocouple is connected to the second negative contact 533 of the corresponding first wire connection assembly 53, and the positive wire of the second thermocouple is connected to the second positive contact 534 of the corresponding first wire connection assembly 53;

[0067] The positive and negative contacts of the third thermocouple, the positive and negative contacts of the fourth thermocouple, and the positive and negative contacts of the fifth thermocouple are respectively connected to the respective thermocouples through corresponding wires.

[0068] The first adjustment knob 54 is adjusted by rotation to connect different electrodes, so that the connected electrode is used as the first target electrode.

[0069] According to the indication of the gear indication ring 51, when the first knob pointer 52 is adjusted to 10, the first target electrode is set as the second electrode;

[0070] When the first knob pointer 52 is adjusted to 20, the first target electrode is set as the third electrode; and so on, when the first knob pointer 52 is adjusted to 30, the first target electrode is set as the fourth electrode; when the first knob pointer 52 is adjusted to 40, the first target electrode is set as the fifth electrode. In this embodiment, the first target electrode is set as the negative electrode.

[0071] Such as Figure 5 、 Figure 6As shown, the first adjusting knob positive electrode ring 544 and the first adjusting knob negative electrode ring 543 of the first adjusting knob 54 are arranged in parallel at intervals and fixed on the inner wall of the circular ring of the first adjusting knob 54. The first adjusting knob positive electrode contact 541 is fixedly connected to the first adjusting knob positive electrode ring 544 by welding, and the first adjusting knob negative electrode contact 542 is fixedly connected to the first adjusting knob negative electrode ring 543 by welding;

[0072] The spacing distance between the first adjusting knob positive electrode contact 541 and the first adjusting knob negative electrode contact 542 is the same as the spacing distance between each thermocouple positive electrode contact and the thermocouple negative electrode contact of the first wire connection assembly 53, and the positions are in one-to-one correspondence and contact, capable of forming a connected circuit.

[0073] The first adjusting knob positive electrode ring 544 is connected to the positive power supply wire of the integrated cable 9, and the first adjusting knob negative electrode ring 543 is connected to the negative power supply wire of the integrated cable 9.

[0074] The first adjusting knob 54 can rotate along the axial vertical plane of the handle 7. By rotating the first adjusting knob 54, the first adjusting knob positive electrode contact 541 and the first adjusting knob negative electrode contact 542 are switched to be connected to different thermocouple positive electrode contacts and thermocouple negative electrode contacts of the first wire connection assembly 53. The first adjusting knob 54 cooperates with the first wire connection assembly 53. Through adjustment, different gears can be selected and different electrodes can be set.

[0075] For example: when the first knob pointer 52 on the first adjusting knob 54 aligns with 10 on the gear indication ring, at this time, the second electrode is the first target electrode. The first adjusting knob positive electrode contact is connected to the second thermocouple positive electrode contact, and the first adjusting knob negative electrode contact is connected to the second thermocouple negative electrode contact. The first adjusting device 5 is connected to the second electrode. At this time, the thermocouple of the second electrode is connected to the integrated cable 9. After the integrated cable 9 is connected to the generator, the temperature of the thermocouple of the second electrode can be monitored. At the same time, since the second thermocouple is assembled with the second electrode, the generator can send a radio frequency signal through the positive wire of the second thermocouple, and this radio frequency signal interacts with the radio frequency signal of the first preset electrode to heat and ablate the area near the two electrodes.

[0076] Specifically, when the first knob pointer 52 of the first adjusting device 5 aligns with the "0" gear of the gear position indicating ring 51, the positive contact 541 of the first adjusting knob and the negative contact 542 of the first adjusting knob are respectively connected to the positive contact and the negative contact of the thermocouple of the first electrode 21. At this time, the first target electrode is set to the first electrode 21. Since the first electrode 21 is fixedly set as the first preset electrode in this embodiment, in this setting mode, both the first preset electrode and the first target electrode are set to the first electrode 21, that is, both the positive electrode and the negative electrode are the first electrode 21. This is a short - circuit situation and cannot work properly.

[0077] Therefore, in terms of structural design, the positive contact and the negative contact of the thermocouple of the first electrode 21 corresponding to the first adjusting device 5 are left open - circuited. The first thermocouple positive contact 532 and the first thermocouple negative contact 531 of the first wire connection assembly 53 are not connected to the first thermocouple of the first electrode 21 by wires. So when the knob pointer of the first adjusting device 5 aligns with the "0" of the gear position indicating ring, the first target electrode is vacant and no electrode is set.

[0078] In an alternative embodiment of the present invention, the first wire connection assembly is a first circular connector, and a first conduction interface of the temperature monitoring device is provided on the first circular connector, and is electrically connected to the temperature monitoring device of the first target electrode through the first conduction interface.

[0079] Specifically, the first wire connection assembly 53 is a first circular connector, which includes multiple pairs of thermocouple positive contacts and thermocouple negative contacts. The specific structure of the first circular connector is as Figure 3 shown. Each pair of adjacent thermocouple negative contacts and thermocouple positive contacts is a group. In this embodiment, there are a total of 5 groups. Each group of thermocouple negative contacts and thermocouple positive contacts corresponds to a thermocouple. The first conduction interface is the thermocouple negative contact and the thermocouple positive contact for setting the electrode. The thermocouple negative contact for setting the electrode is connected to the negative pole of the thermocouple through the first thermocouple negative wire 311, and the thermocouple positive contact for setting the electrode is connected to the positive pole of the first thermocouple through the first thermocouple positive wire 312. The radio - frequency signal of the selected electrode is connected through the first conduction interface to become the first target electrode.

[0080] As Figure 1As shown, in an alternative embodiment of the present invention, the adjustment device further includes: a second adjustment device 6, which is arranged side by side with the first adjustment device 5. The second target electrode among the other electrodes is selected through the second adjustment device 6. The second target electrode, the first target electrode and the first preset electrode form an electrode group. The first preset electrode is the positive electrode, the first target electrode is the negative electrode, the second target electrode has the same polarity as the first preset electrode, and the second target electrode and the first target electrode are different electrodes. The first preset electrode, the first target electrode and the second target electrode ablate the target tissue between the first preset electrode, the first target electrode and the second target electrode according to the received radio frequency signal.

[0081] In this embodiment, the second target electrode is set through the second adjustment device 6. According to the indication of the gear indication ring, when the second knob pointer is adjusted to 0, the distance between the second target electrode and the first electrode 21 is 0, that is, the second target electrode and the first preset electrode are both the first electrode 21; when the second knob pointer is adjusted to 10, the second target electrode is set as the second electrode; when the second knob pointer is adjusted to 20, the second target electrode is set as the third electrode; and so on. Different electrodes are set as the second target electrode by selecting the gear of the adjustment device. In this embodiment, the second target electrode is set as the positive electrode. For example, the first electrode 21 is set as the first preset electrode, the second electrode 22 is set as the first target electrode, and the third electrode 23 is set as the second target electrode. At this time, the first electrode, the second electrode and the third electrode together form an electrode group. After the radio frequency signal is turned on, the electrode group can ablate the target tissue.

[0082] In an alternative embodiment of the present invention, the second adjustment device 6 includes: a second wire connection assembly, which is electrically connected to the temperature monitoring device of each electrode respectively; a second adjustment knob in electrical contact connection with the second wire connection assembly. The temperature monitoring device of the second target electrode among the other electrodes is selected through the second adjustment knob, and is electrically connected to the second target electrode through the temperature monitoring device of the second target electrode.

[0083] In specific implementation, the positive wires and negative wires of the five thermocouples corresponding to the five electrodes are connected to the second adjusting device 6 through a wire connection assembly, so that the second adjusting device 6 can select and set different electrodes as the second target electrode. The composition structure and functional role of the second adjusting device 6 are the same as those of the first adjusting device. According to the indication of the gear indication ring of the second adjusting device 6, when the second knob pointer is adjusted to 10, the second target electrode is the second electrode; when the second knob pointer is adjusted to 20, the second target electrode is the third electrode; and so on. When the second knob pointer is adjusted to 30, the second target electrode is the fourth electrode; when the second knob pointer is adjusted to 40, the second target electrode is the fifth electrode. In this embodiment, the second target electrode is set as the positive electrode.

[0084] Specifically, the second adjusting device is the same as the first adjusting device. The second adjusting knob positive ring and the second adjusting knob negative ring are arranged in parallel at intervals and fixed on the inner wall of the ring of the second adjusting knob. The second adjusting knob positive contact is fixedly connected to the second adjusting knob positive ring by welding, and the second adjusting knob negative contact is fixedly connected to the second adjusting knob negative ring by welding; the interval distance between the second adjusting knob positive contact and the second adjusting knob negative contact is the same as the interval distance between the positive contact and the negative contact of the same group of thermocouples of the second wire connection assembly, and the positions are in one-to-one correspondence and contact, capable of forming a connected circuit. The second adjusting knob positive ring is connected to the positive power supply wire of the integrated cable 9, and the second adjusting knob negative ring is connected to the negative power supply wire of the integrated cable 9. The second adjusting knob can rotate in the axial vertical plane of the handle 7. By rotating the adjusting knob, the second adjusting knob positive contact and the adjusting knob negative contact are switched to be connected to the positive contacts and negative contacts of different thermocouples of the second wire connection assembly. The second adjusting knob cooperates with the second wire connection assembly. By adjusting, different gears can be selected to set different electrodes. For example, when the knob pointer on the second adjusting knob aligns with the gear indication ring "10", at this time, the second electrode is used as the second target electrode. The second adjusting knob positive contact is connected to the second thermocouple positive contact, and the second adjusting knob negative contact is connected to the second thermocouple negative contact. The second adjusting device connects the second electrode. At this time, the second thermocouple of the second electrode is connected to the integrated cable 9. After the integrated cable 9 is connected to the generator, the temperature of the second thermocouple can be monitored. At the same time, since the second thermocouple is assembled with the second electrode, the generator can send a radio frequency signal through the positive wire of the second thermocouple. This radio frequency signal interacts with the radio frequency signal of the first preset electrode to heat and ablate the area near the two electrodes. When setting the second target electrode, the second adjusting device cannot set the same electrode as the first target electrode at the same time.

[0085] In an alternative embodiment of the present invention, the second wire connection assembly is a second circular ring connector, and a second conduction interface of the temperature monitoring device is provided on the second circular ring connector, and is electrically connected to the temperature monitoring device of the second target electrode through the second conduction interface.

[0086] Specifically, the composition structure and functional role of the second wire connection assembly are the same as those of the first wire connection assembly. The second wire connection assembly is a second circular ring connector, which includes multiple pairs of thermocouple positive contacts and thermocouple negative contacts. Each pair of adjacent thermocouple negative contacts and thermocouple positive contacts is a group, and there are a total of 5 groups in this embodiment. Each group of thermocouple negative contacts and thermocouple positive contacts corresponds to a thermocouple. The second conduction interface is the second thermocouple negative contact and the second thermocouple positive contact. The second thermocouple negative contact 533 is connected to the negative electrode of the thermocouple through the first thermocouple negative wire 311, and the second thermocouple positive contact 534 is connected to the positive electrode of the thermocouple through the first thermocouple positive wire 312.

[0087] In an alternative embodiment of the present invention, the radiofrequency ablation device further includes: a gear indication ring, and the first adjustment knob and the second adjustment knob have pointers pointing to the gear indication ring, and gear markings corresponding to each electrode are provided on the gear indication ring.

[0088] Specifically, the gear indication ring 51 is circular and sleeved on the handle 7. Gear scales are evenly distributed on the gear indication ring 51. In this embodiment, five gears of 0, 10, 20, 30, and 40 are engraved. When the knob pointer of the adjustment knob points to the 0 gear, the adjustment device is connected to the first electrode; when it points to the 10 gear, the adjustment device is connected to the second electrode; when it points to the 20 gear, the adjustment device is connected to the third electrode; when it points to the 30 gear, the adjustment device is connected to the fourth electrode; when it points to the 40 gear, the adjustment device is connected to the fifth electrode.

[0089] According to the indication of the gear indication ring 51, when the first knob pointer 52 is adjusted to 10, the first target electrode is set to the second electrode; when the first knob pointer 52 is adjusted to 20, the first target electrode is set to the third electrode; and so on. When the first knob pointer 52 is adjusted to 30, the first target electrode is set to the fourth electrode; when the first knob pointer 52 is adjusted to 40, the first target electrode is set to the fifth electrode. In this embodiment, the first target electrode is set as the negative electrode.

[0090] Further, according to the indication of the gear indicator ring 51, when the pointer of the second knob is adjusted to 0, the distance between the second target electrode and the first electrode 21 is 0, that is, the second target electrode and the first preset electrode are both the first electrode 21; when the pointer of the second knob is adjusted to 10, the second target electrode is the second electrode; when the pointer of the second knob is adjusted to 20, the second target electrode is the third electrode; and so on. By selecting the gear of the adjustment device, different electrodes can be set as the second target electrode. In this embodiment, the second target electrode is set as the positive electrode. For example, the first electrode 21 is set as the first preset electrode, the second electrode 22 is set as the first target electrode, and the third electrode 23 is set as the second target electrode. At this time, the first electrode, the second electrode, and the third electrode together form an electrode group. After the radio frequency signal is turned on, the electrode group can ablate the target tissue.

[0091] In the above embodiment of the present invention, the catheter body 1 of the radiofrequency ablation device is designed to be hollow. There is a puncture needle inlet 8 at the end of the device, where a puncture needle can be placed. The puncture needle penetrates the entire device, and the tip of the puncture needle protrudes from the head end of the radiofrequency ablation device, which can assist the radiofrequency ablation device to reach the lesion location smoothly. It is also possible not to use a puncture needle. Guided by a guide wire, the guide wire penetrates the hollow inner cavity of the radiofrequency ablation device, and the radiofrequency ablation device reaches the lesion location along the guide wire. The puncture needle inlet 8 is designed with a Luer structure, allowing liquid to be injected into the treatment site through this structure during the operation to assist in the treatment.

[0092] Selecting different electrodes as the working electrode using the adjustment device can ablate lesions of different sizes and shapes.

[0093] The cable can connect the radiofrequency ablation device involved in the present invention to the corresponding generator for monitoring and energy supply of the radiofrequency ablation device.

[0094] The generator can monitor the temperature monitoring device, thereby monitoring the temperature of each electrode. When any temperature exceeds the temperature upper limit, the generator stops sending radiofrequency to protect the patient and prevent the device from overheating and damaging human tissues or organs. When the temperature is lower than the set temperature, the generator continues the treatment.

[0095] The radiofrequency ablation device provided by the above embodiments of the present invention can select different electrodes according to requirements, so as to achieve bipolar, tripolar or even multipolar excitation, so as to adjust the distance between the positive and negative electrodes, and can achieve different expected ablation lengths, ablation shapes, etc. In the face of lesions with different diameters or different shapes, the ablation area can cover the entire lesion, and a safety margin of 5-10 mm can be established to ensure the complete ablation of the lesion area. It can match the shape of the lesion area to the greatest extent. In this way, the number of ablations can be reduced, and repeated or multiple ablations can be avoided, so as to avoid damage to the surrounding healthy tissues, or due to possible deviations during the manual operation process, resulting in insufficient local ablation of the lesion.

[0096] As Figure 8 shown, in an optional embodiment of the present invention, a control method for a radiofrequency ablation device is provided, and the method includes:

[0097] Step 801, obtaining regional information of the target tissue;

[0098] Step 802, according to the regional information, determining at least one target electrode among the other electrodes except the first preset electrode in at least two electrodes of the radiofrequency ablation device, the at least one target electrode and the first preset electrode form an electrode group, and the target electrode is any one of the other electrodes;

[0099] Step 803, sending a radiofrequency signal to the electrode group, so that the electrode group ablates the target tissue between the electrode group according to the received radiofrequency signal.

[0100] This method conducts imaging examinations on the target tissue of the patient, delimits the lesion range according to the imaging examination results, and exports a three-dimensional file. The three-dimensional file is input into the generator, and the generator matches the electrode setting method according to the three-dimensional file of the lesion area, so that its ablation shape is accurately matched with the lesion.

[0101] In an optional embodiment of the present invention, the above step 801 may include:

[0102] Step 8011, obtaining a plurality of target image data obtained after the imaging examination device examines the target tissue;

[0103] Step 8012, processing the plurality of target image data to generate a three-dimensional file.

[0104] Among them, step 8012 may specifically include:

[0105] Convert the multiple target image data into grayscale images using a visual image conversion tool. Each grayscale image is represented in a single channel, where the value of each pixel represents its intensity and there is no color channel.

[0106] Find the key points and descriptors in the grayscale images. Use the Scale-Invariant Feature Transform (SIFT) algorithm to find the key points and descriptors in two images. For example, it uses the cv2.SIFT_create() function in OpenCV to create a SIFT object and calls its detectAndCompute method to calculate the key points and descriptors.

[0107] Match the descriptors using a matcher. For example, use the cv2.FlannBasedMatcher function in OpenCV to create a FLANN matcher object and call its knnMatch method to find the k nearest neighbors of each descriptor.

[0108] Use Lowe's ratio test to filter out good matches. Use a threshold of the distance between the nearest neighbor and the second nearest neighbor to determine whether the match is good.

[0109] Extract the matched key points. These key points will be used to estimate the transformation for aligning the two images. These key points can be stored in an array or a database.

[0110] Find the homography matrix. Calculate the homography matrix that describes the transformation between the two images based on the matched key points. The homography matrix can be used to stretch or transform one image to align it with the other image.

[0111] Transform the first image using the homography matrix. Specify that the size of the output image is large enough to accommodate both images, and then render the 3D file.

[0112] Display the original image and the reconstructed 3D file. Visualize the original image and the reconstructed image in a single figure with three subplots, and set the title and axis properties for each subplot.

[0113] Input the 3D file into a radiofrequency energy generator, which stores the shapes and sizes of the radiofrequency ablation regions under different combinations of target electrodes internally.

[0114] For example, ablation region 1 corresponds to the first and second electrodes, and ablation region 2 corresponds to the first, second, and third electrodes, etc.

[0115] In an optional embodiment of the present invention, in step 802, select the first target electrode, the second target electrode, the third target electrode, the fourth target electrode, etc. through the above radiofrequency ablation device.

[0116] In an alternative embodiment of the present invention, step 803 may include:

[0117] The radio frequency energy generator calculates the path for the radio frequency ablation device to reach the lesion location according to the size and range of the three-dimensional file, that is, the optimal insertion point and insertion direction of the radio frequency ablation device.

[0118] The radio frequency ablation device reaches the lesion location according to the path, measures the impedance value at the lesion location, and calculates the radio frequency output parameters. For example, corresponding radio frequency signals are output to the first electrode, the second electrode, and the third electrode respectively, and the working electrode group is controlled to ablate the lesion location.

[0119] During the use of the radio frequency ablation device of the present invention, before the operation, the patient is subjected to X-ray computed tomography, magnetic resonance imaging or other imaging examinations. The lesion range is delimited according to the imaging examination results, and a three-dimensional file is reversely generated through image processing software. For example, X-ray computed tomography has high density resolution, can clearly show the cross-sectional position of the lesion and the relationship between the body organs and the lesion, can quickly obtain ablation lesion data, has the advantages of accurate positioning, timely detection of complications and evaluation of curative effect, and is widely used for lesion examinations. In this embodiment, preoperative CT imaging is adopted, and the real-time guidance method using two-dimensional ultrasound images is used during the implementation process.

[0120] First, calculate the slice matching relationship between the three-dimensional image and the two-dimensional ultrasound based on image features such as edges and contours; secondly, take the image slice-two-dimensional ultrasound registration as an iterative optimization problem, select a suitable similarity measure as the objective function, and use an optimization algorithm to iteratively optimize the spatial transformation matrix of the image slice-two-dimensional ultrasound until the objective function converges to the minimum value or reaches the maximum number of iterations.

[0121] Specifically, preoperative three-dimensional file data of the patient's lesion is collected and the lesion contour features are extracted therefrom; during the operation, this three-dimensional file is input into the generator, and at the same time, ultrasound images are collected in real time and the lesion contour features are extracted therefrom. Through the fast matching method of the two-dimensional ultrasound image and the slice in the three-dimensional data, combined with the two-dimensional image registration method, the spatial position relationship between the ultrasound image and the CT data is determined, so as to realize the fast positioning of the lesion and determine the area where the target tissue is located.

[0122] The generator recommends electrode settings to the operator according to the size and range of the three-dimensional file, that is, the selection of the first target electrode, the second target electrode, the third target electrode, the fourth target electrode, etc. The operator makes a choice by adjusting the knob according to the recommendation. By selecting different electrode setting methods, the purpose of adjusting the distance between the positive and negative electrodes is achieved, so as to realize different ablation ranges.

[0123] More shapes of ablation can also be achieved through the setting of three electrodes or even multiple electrodes, theoretically maximizing the matching of the shape of the lesion area. This can reduce the number of ablation times, avoid multiple or repeated ablations, which may cause damage to the surrounding healthy tissues, or in the manual operation process, due to possible deviations during the operation, resulting in insufficient local ablation of the lesion. For example, the first electrode 21 is used as the first preset electrode and is default set as the positive electrode; the first target electrode is set as the negative electrode, and a first adjustment device 5 is used to select an electrode as the first target electrode; the second target electrode is set as the positive electrode, and a second adjustment device is used to select an electrode as the second target electrode; and so on. The positive and negative polarities of different electrodes and the distances between each working electrode can be set, so that the radiofrequency ablation device can achieve different shapes of ablation treatment.

[0124] For example: when the first preset electrode (positive electrode) is the first electrode and the first target electrode (negative electrode) is the second electrode, the ablation range is similar to an ellipsoid at this time.

[0125] When the first preset electrode (positive electrode) is the first electrode and the first target electrode (negative electrode) is the third electrode, the ablation range is similar to an ellipsoid at this time, and the major axis of the ellipsoid increases compared with the previous setting method.

[0126] When the first preset electrode (positive electrode) is the first electrode, the first target electrode (negative electrode) is the third electrode, and the second target electrode (positive electrode) is the second electrode, since the electric field intensity of the first target electrode (negative electrode) is higher than that of the first preset electrode (positive electrode) and the second target electrode (positive electrode), the temperature of the first target electrode (negative electrode) is higher at this time, and the ablation range is similar to a pear shape.

[0127] When the first preset electrode (positive electrode) is the first electrode 2l, the first target electrode (negative electrode) is the second electrode, and the second target electrode (positive electrode) is the third electrode, since the electric field intensity of the first target electrode (negative electrode) is higher than that of the first preset electrode (positive electrode) and the second target electrode (positive electrode), the temperature of the first target electrode (negative electrode) is higher at this time, and the ablation range is two pear shapes connected at the bottom.

[0128] The generator recommends a treatment path for the operator according to the size and scope of the three-dimensional file, that is, the optimal insertion point and insertion direction of the radiofrequency ablation device. A plurality of adjusting devices are fixedly arranged on the handle 7, and an integrated circuit board can be arranged inside the handle 7 to receive control instructions and realize the automatic control of the electrode settings. The handle 7 of this embodiment is designed to be hollow, and there is a puncture needle inlet 8 at the tail end of the handle 7, where a puncture needle can be placed. The puncture needle penetrates the entire device, and the tip of the puncture needle exposes the head end of the radiofrequency ablation device, which can assist the radiofrequency ablation device to reach the lesion location smoothly. It is also possible not to use a puncture needle. Guided by a guide wire, the guide wire penetrates the hollow inner cavity of the radiofrequency ablation device, and the radiofrequency ablation device reaches the lesion location along the guide wire.

[0129] The radiofrequency ablation device is connected to the radiofrequency energy generator through an integrated cable 9 and a cable connector 10. The generator is used to monitor and supply energy to the radiofrequency ablation device. The generator collects the data generated by the temperature monitoring device to monitor the temperature of each electrode. When the temperature of any electrode exceeds the temperature upper limit, the generator stops sending radiofrequency to protect the patient and prevent the device from overheating and damaging human tissues or organs. When the temperature is lower than the set temperature, the generator continues to send radiofrequency. There is a database inside the generator, which stores the shape and size of the radiofrequency ablation area under different electrode combinations. Due to differences among different individuals, the body fluid impedance values of each person are different. Therefore, among different individuals, under the same radiofrequency output parameters, the shapes of their ablation areas are similar, but the ablation sizes may vary.

[0130] There is a monitoring device inside the generator. Through the cable, the impedance values between working electrodes such as the first preset electrode, the first target electrode, and the second target electrode are monitored, and the body fluid conductivity parameter of the patient is calculated.

[0131] According to the relationship K = Q×G, the value of conductivity can be obtained. Where Q = L / A, Q is the electrode constant, L is the distance between the two electrodes, and A is the effective plate area of the measuring electrode. In the case of a uniform electric field between the electrodes, the electrode constant can be calculated from the geometric dimensions. When two square plates with an area of 1 cm 2 are separated by 1 cm to form an electrode, the constant Q of this electrode = 1 cm -1 . If the conductance value G = 1000 μS is measured with this pair of electrodes, the conductivity K of the measured solution = 1000 μS / cm.

[0132] The conductivity parameter value is used as the calibration of the radiofrequency output parameters to calibrate the magnitude of the radiofrequency output parameters, so that the shape of the final radiofrequency ablation area reaches the size of the built-in ablation area in the database.

[0133] Based on the above, the radiofrequency ablation device involved in the present invention ensures that the ablated range can cover the lesion to be treated through single or multiple treatments, and a safety margin of 5-10 mm is established around the lesion.

[0134] The radiofrequency ablation device described in the present invention can achieve the purpose of adjusting the distance between the positive and negative electrodes by selecting different electrodes, so as to realize different ablation ranges. It can also achieve more ablation shapes through the setting of three electrodes or even multiple electrodes, theoretically matching the shape of the lesion area to the greatest extent. In this way, the number of ablations can be reduced, avoiding damage to the surrounding healthy tissues caused by multiple or repeated ablations, or the result of insufficient local ablation of the lesion due to possible deviations during the manual operation process.

[0135] Before using the radiofrequency ablation device described in the present invention, the operator needs to perform CT or MRI or other imaging examinations on the patient. The operator or other professionals delimit the lesion range according to the imaging examination results and export a three-dimensional file. The three-dimensional file is input into the generator, and the generator matches the electrode setting method according to the three-dimensional file of the lesion area to make its ablation shape accurately match the lesion.

[0136] Through the design of the thermocouple and the electrode ring, the present invention connects the two together. While improving the temperature measurement accuracy, it can reduce the number of cores of the cable and the connector. The two cores of the thermocouple can also set its positive electrode as the radiofrequency output line while measuring the temperature. It can simplify the structure and reduce the cost at the same time.

[0137] The above is the preferred implementation manner of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle described in the present invention, several improvements and retouches can be made, and these improvements and retouches should also be regarded as the protection scope of the present invention.

Claims

1. A radiofrequency ablation device, characterized in that: include: The catheter body; At least two electrodes, the at least two electrodes are distributed at the first end of the catheter body, any two electrodes of the at least two electrodes are insulated and arranged at intervals; The other electrodes of the at least two electrodes except the first preset electrode are all electrically connected to at least two adjustment devices, the at least two adjustment devices are sleeved on the second end of the catheter body, at least one target electrode of the other electrodes is selected by the at least two adjustment devices, the at least one target electrode and the first preset electrode form an electrode group, the electrode group ablates the target tissue between the electrode group according to the received radio frequency signal, and the target electrode is any one of the other electrodes; wherein a first target electrode among the other electrodes is selected by a first adjusting device, the first target electrode and the first preset electrode form an electrode group, and the first preset electrode and the first target electrode ablate the target tissue between the first preset electrode and the first target electrode according to the received radio frequency signal; A second target electrode is selected from the other electrodes through a second adjustment device, and the second target electrode, the first target electrode and the first preset electrode form an electrode group; the first preset electrode, the first target electrode and the second target electrode ablate the target tissue between the first preset electrode, the first target electrode and the second target electrode according to the received radio frequency signal.

2. The radiofrequency ablation device according to claim 1, characterized in that: Each electrode is electrically connected to a temperature monitoring device; the at least two regulating devices are electrically connected to a temperature monitoring device respectively, and the regulating device selects at least one target electrode among the other electrodes through the temperature monitoring device.

3. The radiofrequency ablation device according to claim 1, characterized in that: The first adjusting device comprises: a first wire connection assembly, the first wire connection assembly being electrically connected to a temperature monitoring device of each electrode; A first adjusting knob is in contact and electrically connected with the first wire connection assembly, and a temperature monitoring device of a first target electrode among the other electrodes is selected by the first adjusting knob, and the temperature monitoring device of the first target electrode is electrically connected to the first target electrode.

4. The radiofrequency ablation device according to claim 3, characterized in that: The first wire connection component is a first annular connector, on which a first conductive interface of a temperature monitoring device is provided, and the first conductive interface is electrically connected to the temperature monitoring device of the first target electrode.

5. The radiofrequency ablation device according to claim 3, characterized in that: The second adjusting device comprises: a second wire connection assembly, the second wire connection assembly being electrically connected to a temperature monitoring device of each electrode; A second adjusting knob is in contact and electrically connected with the second wire connection assembly, and a temperature monitoring device of a second target electrode among the other electrodes is selected by the second adjusting knob, and the temperature monitoring device of the second target electrode is electrically connected to the second target electrode.

6. The radiofrequency ablation device according to claim 5, characterized in that: The second wire connection assembly is a second annular connector, on which a second conductive interface of the temperature monitoring device is disposed, and the second conductive interface is electrically connected to the temperature monitoring device of the second target electrode.

7. The radiofrequency ablation device according to claim 5, characterized in that: Also includes: A gear position indicator ring, wherein the first adjusting knob and the second adjusting knob have pointers pointing to the gear position indicator ring, and the gear position indicator ring is provided with a gear position mark corresponding to each electrode.

8. A method for controlling a radiofrequency ablation device, characterized in that: Applied to the radiofrequency ablation device according to any one of claims 1 to 7, the method comprises: Determine the region where the target organization is located; According to the regional information, at least one target electrode among the at least two electrodes of the radiofrequency ablation device except the first preset electrode is determined, the at least one target electrode and the first preset electrode form an electrode group, and the target electrode is any one of the other electrodes.

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