WO2022148151A1 - Electrode assembly, ablation apparatus, and radio frequency ablation device - Google Patents

Abstract

An ablation apparatus and a radio frequency ablation device. The ablation apparatus comprises a first electrode assembly (100) having a first electrode tip (110); the first electrode tip (110) comprises a first protective sheath (113) and a plurality of first electrodes (111) disposed on the first protective sheath (113); the first protective sheath (113) is elongate; the plurality of first electrodes (111) are arranged at intervals along an extension direction of the first protective sheath (113). That is, the plurality of first electrodes (111) simultaneously act on the corresponding tissue so as to form a complete ablation line, thereby achieving a good ablation effect and improving the ablation efficiency. The use of the ablation apparatus can solve the problem in the prior art that an ablation effect of an ablation apparatus is not ideal.

Description

Electrode assemblies, ablation devices, and radiofrequency ablation devices

CROSS-REFERENCE TO RELATED APPLICATIONS

The present disclosure is based on a Chinese patent application with an application number of 202110026550.0, an application date of January 8, 2021, a public name of "ablation device and radiofrequency ablation equipment" and an application number of 202120055068.5, and the application date of January 8, 2021, Priority is claimed on the basis of a Chinese patent application published entitled "Radiofrequency Ablation Device", the disclosure of which is hereby incorporated into this disclosure in its entirety.

technical field

The present disclosure relates to the field of medical devices, and in particular, to an ablation device and a radiofrequency ablation device.

Background technique

Ablation is a common measure for the treatment of atrial fibrillation. The principle is to create one or more ablation lines in the heart tissue, causing tissue necrosis and cutting off abnormal electrical signal conduction for the treatment of atrial fibrillation.

The current ablation treatment is divided into surgical ablation and medical interventional ablation. Surgical ablation is characterized by excellent curative effect and low postoperative recurrence rate, but its obvious shortcomings are large trauma and slow postoperative recovery. Medical interventional ablation is favored by more and more patients because of its small trauma and fast recovery, but medical ablation is point ablation, and its biggest drawback is that it is difficult to form a complete ablation line; Wall work, the ablation depth is limited, and it is difficult to ensure complete dehydration and degeneration of the tissue from the inside to the outside. During the operation, the ablation power is small and the ablation is not complete, but the power is high and it is difficult to control. There are excessive ablation tissue necrosis or even burning through and burning leakage. Therefore, the success rate of medical interventional ablation is much lower than that of surgery.

SUMMARY OF THE INVENTION

The main purpose of the present disclosure is to provide an ablation device and radiofrequency ablation equipment to solve the problems of current surgical ablation with relatively large trauma, slow postoperative recovery, limited use angle, and inconvenient operation; to solve the current medical interventional ablation energy constant , the output power cannot be adjusted according to the ablation effect in a timely manner, resulting in the problem of overburning or impermeability; to solve the problem that the current medical and surgical ablation equipment requires additional equipment for mapping after ablation, and the operation is cumbersome.

A first aspect of the present disclosure provides an ablation device, including: a first electrode assembly, the first electrode assembly including a first electrode tip, the first electrode tip including a first protective sheath and disposed on the first electrode A plurality of first electrodes of the protective sheath; wherein, the first protective sheath is strip-shaped, and the plurality of first electrodes are arranged at intervals along the extending direction of the first protective sheath.

In the ablation device of some embodiments, the first protective sheath is made of a flexible material.

In the ablation device of some embodiments, the first electrode tip further includes: a positioning member, the positioning member is disposed on the first protective sheath, and the first electrode tip is positioned in the heart by the positioning member on the outer membrane.

In the ablation device of some embodiments, the positioning member is a balloon structure, and the positioning member is disposed on the outer wall of the first protective sheath; or when the positioning member is in a retracted state, the positioning member is located at the The inner side of the first protective sheath, when the positioning member is in an expanded state, at least part of the positioning member protrudes from the inner side of the first protective sheath to the outer side of the first protective sheath.

In the ablation device of some embodiments, there are multiple positioning members, and the multiple positioning members are arranged at intervals along the extending direction of the first protective sheath and are independently controlled.

In the ablation device of some embodiments, the positioning member is strip-shaped, square, or circular, and the positioning member extends along the extending direction of the first protective sheath.

In the ablation device of some embodiments, the ablation device further includes: a second electrode assembly, the second electrode assembly including a second electrode tip, the second electrode tip including a plurality of second electrodes, a plurality of the The second electrodes are arranged at intervals along the extending direction of the second electrode tip; wherein the plurality of first electrodes and the plurality of second electrodes are arranged in cooperation with each other, and the second electrode tip is configured to be arranged in the center on the intima, so as to ablate the tissue to be ablated between the first electrode and the second electrode through the first electrode and the second electrode.

In the ablation device of some embodiments, the ablation device further comprises: an ablation circuit, on which the first electrode and the second electrode are both disposed, so as to pass the test of each of the first electrodes and the corresponding all the electrodes. The impedance between the second electrodes adjusts the radio frequency energy between the first electrode and the second electrode for ablation.

In the ablation device of some embodiments, the first electrode tip includes a first magnetic member, the second electrode tip includes a second magnetic member, and the first magnetic member cooperates with the second magnetic member , so that the first electrode end and the second electrode end are relatively fixed.

In the ablation device of some embodiments, both the first magnetic member and the second magnetic member are multiple, the first electrode tip and the second electrode tip are both strip-shaped, and the multiple The first magnetic members are arranged at intervals along the extending direction of the first electrode tip, and a plurality of the second magnetic members are arranged at intervals along the extending direction of the second electrode tip.

In the ablation device of some embodiments, a plurality of the first magnetic elements and a plurality of the first electrodes are arranged alternately and spaced apart, and a plurality of the second magnetic elements and the plurality of the second electrodes are arranged alternately and spaced apart.

In the ablation device of some embodiments, the adjacent first electrodes and the first magnetic members are provided with insulation, and the adjacent second electrodes and the second magnetic members are provided with insulation.

In the ablation device of some embodiments, the opposite surfaces between the adjacent first electrodes and the first magnetic members are all sprayed with insulating paint, or the adjacent first electrodes and the first magnetic members are sprayed with insulating paint. An insulating separator is arranged between the parts; the opposite surfaces between the adjacent second electrodes and the second magnetic parts are sprayed with insulating paint, or, the adjacent second electrodes and the second magnetic parts are sprayed with insulating paint. An insulating partition is arranged between the magnetic parts.

In the ablation device of some embodiments, the outer surfaces of the first magnetic member and the second magnetic member are both coated with an insulating layer.

In some embodiments of the ablation device, the ablation device includes a first electrode circuit, a first magnetic circuit, a second electrode circuit, a second magnetic circuit, the first electrode circuit is connected to the first electrode, the The first magnetic circuit is connected to the first magnetic member, the second electrode circuit is connected to the second electrode, and the second magnetic circuit is connected to the second magnetic member.

In the ablation device of some embodiments, the energization circuits of the two first electrodes are independently arranged to form a mapping electrode pair, so as to use the energization circuits to detect the electrical signal transmission of the tissue to be ablated after ablation.

In the ablation device of some embodiments, the energization circuits of the two second electrodes are independently set to form a mapping electrode pair, so as to use the energization circuits to detect the electrical signal transmission of the tissue to be ablated after ablation; and/or , the energization circuits of the first electrode and the second electrode are independently set to form a pair of mapping electrodes, so as to use the energization circuit to detect the transmission of electrical signals after ablation of the tissue to be ablated.

In the ablation device of some embodiments, the first electrode tip and the second electrode tip are both plural.

In the ablation device of some embodiments, two opposite sides of the first protective sheath are provided with shielding side eaves.

In the ablation device of some embodiments, the plurality of first electrodes included in the first electrode tip are insulated from each other.

In the ablation device of some embodiments, the energization circuits of the plurality of first electrodes are independently provided to individually control each of the first electrodes.

In the ablation device of some embodiments, two adjacent first electrodes of the same first electrode tip form an electrode pair, and the two electrode pairs arranged at intervals are matched to each other so as to be used for testing the two electrode pairs Electrical signaling between tissues.

In the ablation device of some embodiments, two adjacent first electrodes in different first electrode tips form an electrode pair, and the polarities of the two first electrodes in the electrode pair are opposite to detect Electrical signal transfer of tissue between the two first electrodes of the electrode pair.

In some embodiments of the ablation device, the first electrode has an electrode surface disposed toward the tissue to be ablated, and the first protective sheath has a protective sheath surface disposed toward the to-be-ablated device; wherein the electrode The surface is located on the side of the protective sheath surface close to the tissue to be ablated.

In the ablation device of some embodiments, there are multiple first electrodes, and the multiple first electrodes are arranged at intervals along the extending direction of the first electrode tip; the electrode surfaces of the multiple first electrodes are the same as the The minimum distances between the protective sheath surfaces are all the same.

In some embodiments of the ablation device, both the electrode surface and the protective sheath surface are flat.

In the ablation device of some embodiments, there are multiple first electrodes, and the multiple first electrodes are arranged at intervals along the extending direction of the first electrode tip; at least one of the multiple first electrodes The first electrode is provided with a cooling hole for circulating the cooling fluid; and/or, the first protective sheath is provided with a cooling pipe for circulating the cooling fluid.

In the ablation device of some embodiments, at least one of the plurality of first electrodes is provided with 1 to 4 cooling holes.

In the ablation device of some embodiments, the second electrode tip includes a second protective sheath, and the second electrode is disposed on the second protective sheath; the second electrode is made of a metal developing material, so The metal developing material includes at least one of the following materials: platinum, platinum-based alloy, tantalum, gold-plated beryllium bronze; and/or, the second protective sheath is made of a developing material, and the component of the developing material includes sulfuric acid barium.

In the ablation device of some embodiments, the second electrodes are arranged at intervals along the extending direction of the second protective sheath, the second electrodes are sleeved on the second protective sheath, and the electrode surface of the second electrode is located on the second protective sheath. The outer side of the surface of the second protective sheath.

A second aspect of the present disclosure provides a radio frequency ablation device, comprising a radio frequency host and an ablation device connected to the radio frequency host, wherein the ablation device is the ablation device of the first aspect of the present disclosure.

In the radio frequency ablation device of the ablation device in some embodiments, the radio frequency host is connected to the plurality of first electrodes to energize each of the first electrodes; the plurality of first electrodes are all arranged on the first electrodes Protective sheath and independent control.

In the radiofrequency ablation device of the ablation device of some embodiments, the radiofrequency ablation device further includes a second electrode assembly, the second electrode assembly includes a second electrode tip, and the second electrode tip includes a plurality of second electrodes , a plurality of the second electrodes are arranged at intervals along the extension direction of the second electrode tip; the radio frequency host is connected to the plurality of second electrodes to energize each of the second electrodes; wherein, the A plurality of first electrodes and the plurality of second electrodes are arranged in cooperation with each other, and the second electrode tip is configured to be arranged on the endocardium to be positioned on the The site to be ablated between the first electrode and the second electrode is ablated.

Applying the technical solutions of the present disclosure, the ablation device includes a first electrode assembly having a first electrode tip and a second electrode assembly having a second electrode tip. The first electrode assembly and the second electrode assembly can be used independently, and the first electrode tip includes a first protective sheath and a plurality of first electrodes disposed on the first protective sheath; An electrode is arranged at intervals along the extending direction of the first protective sheath, that is, a plurality of first electrodes simultaneously act on the epicardial tissue to form a complete ablation line.

The first electrode and the second electrode of the ablation device are arranged opposite to each other, so that the tissue to be ablated located between the first electrode and the second electrode is ablated by the first electrode and the second electrode. When in use, the first electrode assembly and the second electrode assembly are used as epicardial electrodes and endocardial electrodes, respectively, so that the first electrode assembly and the second electrode assembly act on the epicardium and the endocardium, respectively, to achieve Ablation of the epicardium and endocardium at the same time solves the problems of dynamic ablation in cardiac surgery, but the surgical ablation is relatively traumatic and the postoperative recovery is slow. It also solves the problem of constant medical interventional ablation energy and inability to adjust the output power according to the ablation effect in a timely manner, resulting in excessive ablation. Burning or impermeability of the wall; thus achieving good ablation effect and improving ablation efficiency; it can be seen that the use of the ablation device can solve the problem of unsatisfactory ablation effect of the ablation device in the prior art.

Regardless of endocardial ablation or epicardial ablation or simultaneous ablation of the inner and outer heart models, a single electrode assembly or a working electrode assembly can perform timely mapping to monitor the ablation effect. And it is the problem of point-like mapping, which improves the effect of surgical ablation.

Description of drawings

The accompanying drawings that constitute a part of the present disclosure are used to provide further understanding of the present disclosure, and the exemplary embodiments of the present disclosure and their descriptions are used to explain the present disclosure and do not constitute an improper limitation of the present disclosure. In the attached image:

FIG. 1 shows a schematic structural diagram of a first embodiment in a state of a first electrode assembly of an optional ablation device according to the present disclosure;

FIG. 2 shows a schematic structural diagram of the first embodiment in another state of the first electrode assembly of an optional ablation device according to the present disclosure;

FIG. 3 shows a schematic structural diagram of a second embodiment of the first electrode assembly of an optional ablation device according to the present disclosure;

FIG. 4 shows a schematic structural diagram of the first electrode tip of the first electrode assembly of the ablation device in FIG. 1;

FIG. 5 shows a schematic structural diagram of the positioning member of the first electrode assembly of the ablation device in FIG. 1;

FIG. 6 shows a cross-sectional view of the first electrode tip of the first electrode assembly of the ablation device of FIG. 1;

FIG. 7 shows a structural diagram when the positioning member of the first electrode assembly of the ablation device in FIG. 1 is a suction cup;

FIG. 8 shows a schematic structural diagram of a second electrode assembly of an optional ablation device according to the present disclosure;

FIG. 9 shows a partial enlarged view of the second electrode assembly of the ablation device of FIG. 8;

FIG. 10 shows an enlarged view of part A of the second electrode assembly of the ablation device in FIG. 9;

FIG. 11 shows a schematic structural diagram of a radio frequency host of an optional radio frequency ablation device according to the present disclosure;

12 shows an assembly diagram between a radio frequency host and an ablation device of an optional radio frequency ablation device according to the present disclosure;

FIG. 13 shows a schematic diagram of the ablation device in the present disclosure when the tissue to be ablated is ablated;

FIG. 14 shows a diagram of an embodiment of cooperation between the first electrode and the second electrode of the ablation device of the present disclosure and the tissue to be ablated;

FIG. 15 shows a schematic diagram of ablation in one state of the ablation device of the present disclosure;

FIG. 16 shows a schematic diagram of an ablation of another state of the ablation device of the present disclosure;

FIG. 17 shows a schematic diagram of the wiring between the radio frequency host and the first electrode assembly and the second electrode assembly of the radio frequency ablation device of the present disclosure;

FIG. 18 shows a schematic structural diagram of the second embodiment of the first electrode assembly of the ablation device of the present disclosure;

FIG. 19 shows a schematic structural diagram of the second embodiment of the second electrode assembly of the ablation device of the present disclosure;

20 shows a diagram of another embodiment of the cooperation between the first electrode and the second electrode of the ablation device of the present disclosure and the tissue to be ablated.

Wherein, the above-mentioned drawings include the following reference signs:

100. A first electrode assembly;

110, first electrode tip; 111, first electrode; 1110, electrode surface; 1112, cooling hole; 112, first magnetic member; 113, first protective sheath; 114, positioning member; 1130, protective sheath surface; 115 , cover the side eaves;

120. Conductor laying groove;

200. A second electrode assembly;

210, the second electrode tip; 211, the second electrode; 212, the second magnetic member; 213, the developing member; 214, the second protective sheath; 260, the control handle;

310, radio frequency host; 311, ablation interface; 312, electromagnetic interface; 313, display screen; 320, ablation circuit; 330, ablation range; 340, tissue to be ablated.

Detailed ways

It should be noted that the embodiments of the present disclosure and the features of the embodiments may be combined with each other under the condition of no conflict. The present disclosure will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.

The present disclosure provides an ablation device. Please refer to FIG. 1 to FIG. 20 , the ablation device includes a first electrode assembly 100 , the first electrode assembly 100 includes a first electrode tip 110 , and the first electrode tip 110 includes a first protective sheath 113 and is disposed on the first protective sheath The plurality of first electrodes 111 of 113 ; wherein, the first protective sheath 113 is strip-shaped, and the plurality of first electrodes 111 are arranged at intervals along the extending direction of the first protective sheath 113 .

In the ablation device of the present disclosure, the ablation device includes a first electrode assembly 100 having a first electrode tip 110 , and the first electrode tip 110 includes a first protective sheath 113 and a plurality of first protective sheaths 113 . an electrode 111; and, the first protective sheath 113 is strip-shaped, and a plurality of first electrodes 111 are arranged at intervals along the extending direction of the first protective sheath 113; In order to form a complete ablation line, to achieve good ablation effect and improve ablation efficiency; it can be seen that the use of the ablation device can solve the problem of unsatisfactory ablation effect of the medical interventional ablation device in the prior art.

In addition, by arranging the plurality of first electrodes 111 at intervals, mutual influence between two adjacent first electrodes 111 can be avoided.

In this embodiment, the number of the first electrodes 111 is 2 to 10.

Optionally, the first protective sheath 113 is tubular, and the plurality of first electrodes 111 are disposed in the lumen of the first protective sheath 113 .

In some embodiments, the first protective sheath 113 is made of a flexible material, and the first protective sheath 113 can swing in the X, Y, and Z directions.

In this embodiment, the first electrode tip 110 further includes a positioning member 114 , the positioning member 114 is disposed on the first protective sheath 113 , and the first electrode tip 110 is positioned on the epicardium through the positioning member 114 .

Optionally, there are multiple positioning members 114, and the multiple positioning members 114 are arranged at intervals along the extending direction of the first protective sheath 113, so that the first electrode tip 110 can be stably positioned on the epicardium and ensure that the first electrode tip 110 positioning effect.

Optionally, the positioning member 114 is an airbag structure.

In this embodiment, a setting method of the positioning member 114 is as follows: as shown in FIG. 3 , the positioning member 114 is arranged on the outer wall of the first protective sheath 113; during the implementation process, the airbag structure is inflated to expand it, In order to make the balloon structure form a squeezing effect on the first protective sheath 113, under the squeezing effect, the first protective sheath 113 is attached to the corresponding tissue to be ablated, so that the first electrode 111 in the first protective sheath 113 can be Act on the corresponding ablated tissue.

Optionally, an accommodating groove is provided on the outer wall of the first protective sheath 113, and when the airbag structure is in a contracted state, the airbag structure is accommodated in the accommodating groove; when the airbag structure is in an inflated state, at least part of the airbag structure is The accommodating groove comes out to form a squeezing effect on the first protective sheath 113; when there are multiple positioning members 114, a plurality of accommodating grooves are arranged on the outer wall of the first protective sheath 113, and the plurality of accommodating grooves are along the first protective sheath 113. The extension directions of the sheaths 113 are arranged at intervals. In this embodiment, the positioning members of the plurality of airbag structures all have independent ventilation air paths, which can independently control the working state of each airbag structure.

In this embodiment, as shown in FIG. 4 , another arrangement of the positioning member 114 is as follows: when the positioning member 114 is in a retracted state, the positioning member 114 is located inside the first protective sheath 113 , and when the positioning member 114 is in an expanded state In the state, at least part of the positioning member 114 protrudes from the inner side of the first protective sheath 113 to the outer side of the first protective sheath 113, so as to form a pressing effect on the first protective sheath 113 when the airbag structure is inflated.

Optionally, the positioning member 114 is strip-shaped, square, or circular, and the positioning member 114 extends along the extending direction of the first protective sheath 113 .

In this embodiment, the ablation device further includes a second electrode assembly 200, the second electrode assembly 200 includes a second electrode tip 210, the second electrode tip 210 includes a plurality of second electrodes 211, and the plurality of second electrodes 211 are located along the The extension directions of the second electrode tips 210 are arranged at intervals; wherein the plurality of first electrodes 111 and the plurality of second electrodes 211 are arranged in cooperation with each other, and the second electrode tips 210 are arranged on the endocardium to pass through the first electrodes 111 and 211. The second electrode 211 ablates the tissue to be ablated between the first electrode 111 and the second electrode 211 .

Optionally, the ablation device further includes an ablation circuit 320, and the first electrode 111 and the second electrode 211 are both disposed on the ablation circuit 320, so as to adjust the first electrode 111 and the corresponding second electrode 211 by testing the impedance between the first electrodes 111 and the corresponding second electrodes 211. Ablation is performed by radio frequency energy between the first electrode 111 and the second electrode 211 .

In use, the first electrode assembly 100 is used as an epicardial electrode, so that the first electrode assembly 100 and the second electrode assembly 200 act on the epicardium and the endocardium, respectively, so as to achieve simultaneous ablation of the epicardium and the endocardium membrane to achieve a good ablation effect. In addition, the ablation device in the present disclosure can realize hybrid ablation of internal and surgical techniques. This technique has little trauma, which solves the problems of large trauma and slow recovery in the prior art for surgical ablation. Simultaneous ablation adjusts the output power by testing the actual impedance between tissues, which is accurate and safe, and the machine alarms when the impedance reaches a certain resistance value to complete the ablation to avoid excessive ablation.

In addition, by arranging each of the first electrodes 111 and the corresponding second electrodes 211 opposite to each other, the impedance between each of the first electrodes 111 and the corresponding second electrode 211 can be tested in real time, and according to the real-time detection of the impedance of each of the first electrodes 111 and the corresponding second electrodes 211 The impedance between the corresponding second electrodes 211 is adjusted to adjust the radio frequency energy between each first electrode 111 and the corresponding second electrode 211 to perform ablation, and the machine will alarm when the impedance reaches a certain resistance value, and the ablation is completed, so as to avoid excessive ablation and avoid excessive ablation. It solves the problem of limited depth of unilateral ablation of interventional ablation in the prior art, and it is difficult to ensure complete dehydration and degeneration of the tissue from the inside to the outside. At the same time, it solves the problem that the power of radio frequency is not easy to control. Smaller power will cause incomplete ablation and excessive power. Cause excessive ablation, tissue necrosis or even burn through, burning leakage.

During the ablation process, the impedance of the tissue to be ablated between the electrodes changes from low to high; in the first stage of ablation, the impedance of the tissue to be ablated between the electrodes gradually increases, and the RF power remains unchanged to accelerate the intracellular molecules. Vibration; in the second stage of ablation, as the impedance of the ablated tissue between the electrodes increases, the radio frequency power gradually increases, and when the impedance of the ablated tissue between the electrodes increases to its first preset value, the radio frequency power It also increases to its preset maximum value. In this ablation stage, the cells are rapidly dehydrated to produce irreversible changes; in the third stage of ablation, as the impedance of the ablated tissue between the electrodes continues to increase, the RF power gradually increases. It is decreased to ensure the completeness of ablation and prevent the phenomenon of scarring on the tissue surface or damage to the patient caused by the high power output of the radio frequency; until the impedance of the ablated tissue between the electrodes increases to its second preset value, the end of the ablation is prompted.

In this embodiment, the first electrode tip 110 includes a first magnetic member 112 , the second electrode tip 210 includes a second magnetic member 212 , and the first magnetic member 112 and the second magnetic member 212 cooperate to make the first The electrode tip 110 and the second electrode tip 210 are relatively fixed, so that each first electrode 111 of the first electrode tip 110 can be disposed opposite to the corresponding second electrode 211 of the second electrode tip 210 .

Optionally, as shown in FIG. 2 and FIG. 7 , both the first magnetic member 112 and the second magnetic member 212 are multiple, the first electrode tip 110 and the second electrode tip 210 are both strip-shaped, and the multiple A magnetic member 112 is arranged at intervals along the extending direction of the first electrode tip 110 , and a plurality of second magnetic members 212 are arranged at intervals along the extending direction of the second electrode tip 210 to ensure the first electrode tip 110 and the second electrode tip Overall fixation effect between heads 210.

In some embodiments, the plurality of first magnetic elements 112 and the plurality of first electrodes 111 are alternately disposed, and the plurality of second magnetic elements 212 and the plurality of second electrodes 211 are alternately disposed.

In some embodiments, the adjacent first electrodes 111 and the first magnetic members 112 are provided in insulation, and the adjacent second electrodes 211 and the second magnetic members 212 are provided in insulation.

In some embodiments, the opposite surfaces between the adjacent first electrodes 111 and the first magnetic members 112 are sprayed with insulating paint, or an insulating spacer is provided between the adjacent first electrodes 111 and the first magnetic members 112 The opposite surfaces between the adjacent second electrodes 211 and the second magnetic members 212 are all sprayed with insulating paint, or an insulating separator is provided between the adjacent second electrodes 211 and the second magnetic members 212 . Integrated design of insulating baffle and protective sheath or separate fixed setting.

In some embodiments, the outer surfaces of the first magnetic member 112 and the second magnetic member 212 are both coated with an insulating layer.

In some embodiments, the ablation device includes a first electrode circuit, a first magnetic circuit, a second electrode circuit, and a second magnetic circuit. The first electrode circuit is connected to the first electrode 111 , and the first magnetic circuit is connected to the first magnetic member 112 . The second electrode circuit is connected to the second electrode 211 , and the second magnetic circuit is connected to the second magnetic member 212 . The plurality of first electrodes, second electrodes, first magnetic parts, and second magnetic parts can work independently, so that the magnetic properties can be adjusted and the number of ablation electrodes can be adjusted.

In some embodiments, the energization circuits of the two first electrodes 111 are independently set to form a mapping electrode pair, so as to use the energization circuits to detect the electrical signal transmission of the tissue to be ablated 340 after ablation. During mapping, the polarities of the two first electrodes 111 forming the mapping electrode pair are different, and the voltage across the voltage is set to form a current, thereby realizing mapping; the polarities of the two second electrodes 211 forming the mapping electrode pair are different, The cross-voltage is set to form a current, and then the mapping is realized; the polarities of the first electrode and the second electrode that form the mapping electrode pair are different, and the cross-voltage is set to form a current, and then the mapping is realized.

In some embodiments, the energization circuits of the two second electrodes 211 are independently set to form a mapping electrode pair, so as to use the energization circuits to detect the electrical signal transmission of the tissue to be ablated 340 after ablation; and/or, the first electrodes 111 The energization circuit of the second electrode 211 is independently provided to form a mapping electrode pair, so as to use the energization circuit to detect the transmission of electrical signals after the ablation of the tissue 340 to be ablated.

During mapping, the polarities of the two adjacent first electrodes 111 at the same or different electrode ends are different, and the cross-voltage is set to form a current, so as to realize the mapping; The polarities are different, and the voltages are set across the voltage to form a current, which in turn enables mapping. In this way, the first electrode pair and the second electrode pair can cooperate with each other.

Optionally, each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs.

Optionally, the magnetic force of the magnetic piece is controllable and adjustable, a small magnetic force is used in the initial positioning, and a large magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible in the initial positioning and firm in the final positioning, so as to ensure the electrode assembly. The degree of fit, thereby ensuring the ablation effect.

Optionally, the plurality of first magnetic members 112 are all disposed in the lumen of the first protective sheath 113 .

Optionally, the first magnetic member 112 is an electromagnet or a permanent magnet; and/or the second magnetic member 212 is an electromagnet or a permanent magnet.

Optionally, the plurality of first magnetic members 112 are all disposed in the first protective sheath 113 , and the plurality of first magnetic members 112 are disposed at intervals along the extending direction of the first protective sheath 113 . Optionally, the plurality of first magnetic members 112 and the plurality of first electrodes 111 are alternately arranged along the extending direction of the first protective sheath 113 , so that the plurality of first electrodes 111 are arranged at intervals, that is, each first magnetic member 112 is used to separate the plurality of first electrodes 111 . The corresponding two first electrodes 111 are turned on. During operation, each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs. The magnetic force of the magnetic parts is controllable and adjustable. A small magnetic force is used in the initial positioning, and a larger magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible at the initial positioning and firm after the final positioning, so as to ensure the fit of the electrodes. , thereby ensuring the ablation effect.

In this embodiment, as shown in FIG. 2 , the opposite sides of the first protective sheath 113 are provided with shielding side eaves 115 , so as to protect the plurality of first electrodes 111 and the plurality of first magnetic fields inside the first protective sheath 113 . Each of the components 112 forms a shielding and protective effect, so as to prevent blood and the like from the epicardial tissue from entering the area between the first protective sheath 113 and the epicardium during the ablation process, thereby affecting the tightness between the first protective sheath 113 and the epicardium. , to avoid the measurement accuracy of the resistance value between the first electrode 111 and the second electrode during ablation, thereby affecting the ablation effect.

Optionally, the shielding side eave 115 is strip-shaped, and the shielding side eave 115 extends along the extending direction of the first protective sheath 113 . By setting the shielding side eave 115, the tissue fluid outside the ablation line and liquids such as physiological saline can be shielded from entering the ablation tissue, avoiding the measurement accuracy of the resistance value between the first electrode and the second electrode during ablation, thereby affecting the ablation effect.

Optionally, the first electrode 111 and/or the first magnetic member 112 are provided with wire laying grooves 120 for accommodating wires, and the wires are used to connect with the first electrode 111; or, the wire laying grooves 120 for laying wires It is arranged on the inner wall of the first protective sheath 113 .

In some embodiments, the plurality of first electrodes 111 included in the first electrode terminal 110 are insulated from each other.

In some embodiments, the energization circuits of the plurality of first electrodes 111 are provided independently, so as to individually control each of the first electrodes 111 .

In some embodiments, the energization circuits of two adjacent first electrodes are independently arranged to form an ablation electrode pair to achieve an ablation function.

In some embodiments, two adjacent first electrodes 111 of the same first electrode tip 110 form an electrode pair, and the two electrode pairs arranged at intervals are matched to each other so as to test the tissue between the two electrode pairs transmission of electrical signals.

In some embodiments, two adjacent first electrodes 111 in different first electrode terminals 110 form an electrode pair, and the polarities of the two first electrodes in the electrode pair are opposite, so as to detect the two first electrodes of the electrode pair. Transmission of electrical signals to tissue between an electrode.

In some embodiments, the plurality of second electrodes 211 included in the second electrode terminal 210 are insulated from each other.

In some embodiments, the energization circuits of the plurality of second electrodes 211 are set independently to control each second electrode 211 individually.

In some embodiments, two adjacent second electrodes 211 of the same second electrode tip 210 form an electrode pair, and the two electrode pairs arranged at intervals are matched to each other for testing the tissue between the two electrode pairs. transmission of electrical signals.

In some embodiments, two adjacent second electrodes 211 in different second electrode terminals 210 form an electrode pair, and the polarities of the two second electrodes in the electrode pair are opposite, so as to detect the two second electrodes of the electrode pair. Transmission of electrical signals to tissue between an electrode.

The second electrode assembly 200 includes a manipulation handle 260 and a plurality of second electrode ends 210 , the number of the second electrodes 211 of the plurality of second electrode ends 210 is different, and one of the plurality of second electrode ends 210 is the first The two electrode terminals 210 are selectively connected to the manipulation handle 260 ; the plurality of second electrode terminals 210 and the plurality of first electrode terminals 110 are arranged to cooperate with each other.

In this embodiment, as shown in FIGS. 7 and 8 , the second electrode tip 210 includes a second protective sheath 214 , and the second electrode 211 is disposed on the second protective sheath 214 ; wherein the second electrode tip 210 includes a second protective sheath 214 . The developing member 213, the developing member 213 is disposed on the second protective sheath 214, so as to mark the position of the second electrode end 210 by the developing member 213; and/or, the second electrode 211 is made of a metal developing material, and the metal developing material includes At least one of the following materials: platinum, platinum-based alloy, tantalum, gold-plated beryllium bronze; and/or, the second protective sheath 214 is made of a developing material, and the composition of the developing material includes barium sulfate (BaSO4).

Optionally, the plurality of second magnetic members 212 and the plurality of second electrodes 211 are sleeved on the second protective sheath 214; The extension directions of the protective sheaths are staggered, so that the plurality of second electrodes 211 are arranged at intervals, that is, each second magnetic member 212 is used to separate the corresponding two second electrodes 211 .

Optionally, referring to FIG. 14 and FIG. 20 , the plurality of second magnetic members 212 and the plurality of second electrodes 211 are annular structures, or have cross-sectional structures such as square, V-shape, D-shape, and arch. As shown in FIG. 20 , the cross section of the second electrode 211 is a polygon, such as a square.

In this embodiment, the developing member 213 , the second electrode 211 with a developing function, and the second protective sheath 214 with a developing function can indicate the position when the second electrode assembly 200 enters the ablation tissue. Optionally, the number of developing members 213 on the second electrode end 210 is 1-6, and the number of the developing members 213 may be set independently or the second electrode 211 may have a developing function. In this embodiment, the outer walls of the developing member 213 and the second protective sheath 214 are flush to prevent damage to the patient during the operation.

In this embodiment, the second electrodes 211 are arranged at intervals along the extending direction of the second protective sheath 214 , the second electrodes 211 are sleeved on the second protective sheath 214 , and the electrode surface of the second electrode is located on the surface of the second protective sheath 214 outside. The developing member may be absent, or there may be a plurality of developing members 213, and the plurality of developing members 213 are arranged at intervals along the extending direction of the second protective sheath 214; The part of the first surface part and the second surface part connected with the first surface part are formed, the first surface part is a concave structure, the developing part 213 is sleeved on the first surface part, and the outer surface of the developing part 213 is connected to the second surface part. The portion is flush with or lower than the second surface portion.

During operation, the first electrode assembly 100 is first fixed on the epicardium through the positioning member, then the second electrode assembly 200 enters the heart, and the second electrode assembly 200 is placed in the endocardium through the indication of the developing member 213. At the corresponding part of the electrode assembly 100, the first pair of magnetic parts, the second pair of magnetic parts and the third pair of magnetic parts located at the first electrode end 110 and the second electrode end 210 are turned on synchronously and sequentially. At this time, two sets of electrodes Complete initial positioning. After completing the initial positioning, the two electrode assemblies then turn on the remaining magnetic parts in pairs to complete the final positioning.

Optionally, when the first electrode 111 and the second electrode 211 work, each pair of electrodes is relatively independent, that is, the number of working electrodes can be controlled.

In this embodiment, as shown in FIG. 5 , the first electrode 111 has an electrode surface 1110 disposed toward the tissue to be ablated, and the first protective sheath 113 has a protective sheath surface 1130 disposed toward the tissue to be ablated; wherein, the electrode surface 1110 is located on the The protective sheath 1130 is close to the side of the tissue to be ablated.

In this embodiment, there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; between the electrode surfaces 1110 of the multiple first electrodes 111 and the protective sheath surface 1130 The minimum distances are the same. The value range of the minimum distance between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is 0-0.5 mm. The existence of this height difference can make the first electrode fully contact the surface to be ablated to ensure the ablation effect. The height difference between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is preferably 0.2 mm.

In this embodiment, the electrode surface 1110 and the protective sheath surface 1130 are both flat surfaces.

In order to achieve cooling of the first electrode tip 110, as shown in FIG. 5, there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; At least one of the first electrodes 111 in the 111 is provided with a cooling hole 1112 for circulating a cooling fluid; and/or a cooling pipe for circulating a cooling fluid is provided in the first protective sheath 113 . In this embodiment, the cooling holes 1112 are provided for local cooling during the ablation process, so as to protect other parts other than the ablated tissue from being damaged. By providing cooling channels, cooling can be performed on the sides of the electrodes.

In this embodiment, at least one of the plurality of first electrodes 111 is provided with 1 to 4 cooling holes 1112 . The number of cooling holes on each first electrode 111 is 0-4 to ensure temperature control during ablation.

The present disclosure also provides a radio frequency ablation device. As shown in FIG. 10 , the radio frequency ablation device includes a radio frequency host 310 and the above-mentioned ablation device, and the ablation device is connected to the radio frequency host 310 .

Optionally, as shown in FIG. 9 , the radio frequency host 310 is provided with a display screen 313 , and the display screen 313 is used to display the measured values of the tissue to be ablated between the two corresponding first electrodes 111 and the second electrodes 211 . Impedance and/or RF Power.

Optionally, the radio frequency host 310 is further provided with an ablation interface 311, the first electrode assembly 100 and the second electrode assembly 200 each include a plurality of lead assemblies, and each lead assembly includes a lead connector and a plurality of parallel connection connected to the lead connector. Lead wires, each lead wire is used to connect with the corresponding electrode; the ablation interface 311 has a first ablation interface part and a second ablation interface part, and the first ablation interface part has a plurality of lead wires for inserting the plurality of lead wires of the first electrode assembly 100. a first ablation interface, the second ablation interface part has a plurality of second ablation interfaces for inserting a plurality of lead wires of the second electrode assembly 200, so as to communicate with the corresponding The first electrode 111 and the corresponding second electrode 211 provide suitable radio frequency power.

Optionally, when the first magnetic member 112 and the second magnetic member 212 are both electromagnets, the radio frequency host 310 is further provided with an electromagnetic interface 312, and both the first electrode assembly 100 and the second electrode assembly 200 include a plurality of electromagnets. components, each electromagnet assembly includes an electromagnetic joint and a plurality of electromagnetic wires connected in parallel with the electromagnetic joint, and each electromagnetic wire is used to connect with the corresponding electromagnet; the electromagnetic interface 312 has a first electromagnetic interface part and a second electromagnetic interface part , the first electromagnetic interface part has a plurality of first magnetic interfaces for inserting a plurality of electromagnetic joints of the first electrode assembly 100 , and the second electromagnetic interface part has a plurality of electromagnetic joints for inserting a plurality of electromagnetic joints of the second electrode assembly 200 a plurality of second magnetic interfaces, so as to supply power to the corresponding first magnetic member 112 and the corresponding second magnetic member 212 through each of the first magnetic An attraction force is generated between the second magnetic members 212 .

Referring to FIG. 12 to FIG. 16 , it can be seen that the ablation device in this embodiment ablation principle of the tissue 340 to be ablated, and can reflect the ablation range 330 of the ablation device.

From the above description, it can be seen that the above-mentioned embodiments of the present disclosure achieve the following technical effects:

In the ablation device of the present disclosure, the ablation device includes a first electrode assembly 100 having a first electrode tip 110 and a second electrode assembly 200 having a second electrode tip 210 . The first electrode assembly 100 and the second electrode assembly 200 can be used independently. The first electrode tip 110 includes a first protective sheath 113 and a plurality of first electrodes 111 disposed on the first protective sheath 113 ; and the first protective sheath 113 In strip shape, the plurality of first electrodes 111 are arranged at intervals along the extending direction of the first protective sheath 113 ; that is, a complete ablation line is formed by simultaneously acting on the corresponding tissues of the plurality of first electrodes 111 .

The first electrode and the second electrode of the ablation device are arranged opposite to each other, so that the tissue to be ablated located between the first electrode and the second electrode is ablated by the first electrode and the second electrode. When in use, the first electrode assembly and the second electrode assembly are used as epicardial electrodes and endocardial electrodes, respectively, so that the first electrode assembly and the second electrode assembly act on the epicardium and the endocardium, respectively, to achieve Ablation of the epicardium and endocardium at the same time solves the problems of dynamic ablation in cardiac surgery, but the surgical ablation is relatively traumatic and the postoperative recovery is slow. It also solves the problem of constant medical interventional ablation energy and inability to adjust the output power according to the ablation effect in a timely manner, resulting in excessive ablation. Burning or impermeability of the wall; thus achieving good ablation effect and improving ablation efficiency; it can be seen that the use of the ablation device can solve the problem of unsatisfactory ablation effect of the ablation device in the prior art.

Regardless of endocardial ablation or epicardial ablation or simultaneous ablation of the inner and outer heart models, a single electrode assembly or a working electrode assembly can perform timely mapping to monitor the ablation effect. And it is the problem of point-like mapping, which improves the effect of surgical ablation.

The radio frequency ablation device of the present disclosure includes the above-mentioned ablation device, so the radio frequency ablation device has at least the same technical effect as the ablation device.

The present disclosure provides a radio frequency ablation device. Please refer to FIGS. 1 to 20 , the radiofrequency ablation device includes a first electrode assembly 100 , the first electrode assembly 100 includes a first electrode tip 110 , and the first electrode tip 110 includes a first protective sheath 113 and is disposed on the first protective sheath 113 . The plurality of first electrodes 111 of the sheath 113; the radio frequency host 310, the radio frequency host 310 is connected to the plurality of first electrodes 111 to energize each of the first electrodes 111; wherein, the first protective sheath 113 is a strip-shaped structure, and a plurality of first electrodes 111 are provided. The electrodes 111 are all disposed on the first protective sheath 113 and are arranged at intervals along the extending direction of the first protective sheath 113 . Optionally, the plurality of first electrodes are independently controlled.

In the radio frequency ablation device of the present disclosure, the radio frequency ablation device includes a first electrode assembly 100 having a first electrode tip 110 and a radio frequency host 310. The first electrode tip 110 includes a first protective sheath 113 and is disposed on the first protective sheath 113. The plurality of first electrodes 111 of the sheath 113; the radio frequency host 310 is connected to the plurality of first electrodes 111 to energize each of the first electrodes 111; and the first protective sheath 113 is a tube body, and the plurality of first electrodes 111 are provided In the lumen of the first protective sheath 113 and at intervals along the extending direction of the first protective sheath 113; that is, a plurality of first electrodes 111 act on their corresponding tissues at the same time to form a complete ablation line, thereby realizing Good ablation effect and improve ablation efficiency.

In addition, by arranging the plurality of first electrodes 111 at intervals, mutual influence between two adjacent first electrodes 111 can be avoided.

In this embodiment, there are 5 to 10 first electrodes 111 .

In this embodiment, the first electrode tip 110 further includes a positioning member 114 , the positioning member 114 is disposed on the first protective sheath 113 , and the first electrode tip 110 is positioned on the epicardium through the positioning member 114 .

Optionally, there are multiple positioning members 114, and the multiple positioning members 114 are arranged at intervals along the extending direction of the first protective sheath 113, so that the first electrode tip 110 can be stably positioned on the epicardium and ensure that the first electrode tip 110 positioning effect. In this embodiment, there are 2 to 5 positioning members 114 .

Optionally, the positioning member 114 is an airbag structure.

In this embodiment, a setting method of the positioning member 114 is as follows: as shown in FIG. 5 , the positioning member 114 is arranged on the outer wall of the first protective sheath 113; In order to make the balloon structure form a squeezing effect on the first protective sheath 113, under the squeezing effect, the first protective sheath 113 is attached to the corresponding tissue to be ablated, so that the first electrode 111 in the first protective sheath 113 can be Act on the corresponding ablated tissue.

Optionally, an accommodating groove is provided on the outer wall of the first protective sheath 113, and when the airbag structure is in a contracted state, the airbag structure is accommodated in the accommodating groove; when the airbag structure is in an inflated state, at least part of the airbag structure is The accommodating groove comes out to form a squeezing effect on the first protective sheath 113; when there are multiple positioning members 114, a plurality of accommodating grooves are arranged on the outer wall of the first protective sheath 113, and the plurality of accommodating grooves are along the first protective sheath 113. The extension directions of the sheaths 113 are arranged at intervals.

In this embodiment, as shown in FIG. 6 , another arrangement of the positioning member 114 is as follows: when the positioning member 114 is in a retracted state, the positioning member 114 is located inside the first protective sheath 113 , and when the positioning member 114 is in an expanded state In the state, at least part of the positioning member 114 protrudes from the inner side of the first protective sheath 113 to the outer side of the first protective sheath 113, so as to form a pressing effect on the first protective sheath 113 when the airbag structure is inflated.

Optionally, the positioning member 114 is strip-shaped, and the positioning member 114 extends along the extending direction of the first protective sheath 113 .

In this embodiment, the radiofrequency ablation device further includes a second electrode assembly 200 , the second electrode assembly 200 includes a second electrode tip 210 , the second electrode tip 210 includes a plurality of second electrodes 211 , and a plurality of second electrodes 211 They are arranged at intervals along the extending direction of the second electrode tip 210 ; the radio frequency host 310 is connected to the plurality of second electrodes 211 to energize each second electrode 211 ; wherein the plurality of first electrodes 111 and the plurality of second electrodes 211 are connected to each other In cooperation with the arrangement, the second electrode tip 210 is arranged on the endocardium to ablate the site to be ablated between the first electrode 111 and the second electrode 211 through the first electrode 111 and the second electrode 211 .

Optionally, the radio frequency ablation device further includes an ablation circuit 320, and the first electrode 111 and the second electrode 211 are both disposed on the ablation circuit 320, so as to adjust the impedance between each first electrode 111 and the corresponding second electrode 211 by testing Ablation is performed by radio frequency energy between the first electrode 111 and the second electrode 211 .

In use, the first electrode assembly 100 is used as an epicardial electrode, so that the first electrode assembly 100 and the second electrode assembly 200 act on the epicardium and the endocardium, respectively, so as to achieve simultaneous ablation of the epicardium and the endocardium membrane to achieve a good ablation effect. In addition, the radio frequency ablation device in the present disclosure can realize hybrid ablation of endocardium and surgery, which is less traumatic, and can simultaneously ablate the epicardium and the endocardium simultaneously. , safe, and after the impedance reaches a certain resistance value, the machine will alarm and the ablation is completed to avoid excessive ablation. Although the cardiac surgery is dynamic ablation, the surgical ablation trauma is relatively large and the postoperative recovery is slow.

In addition, by arranging each of the first electrodes 111 and the corresponding second electrodes 211 opposite to each other, the impedance between each of the first electrodes 111 and the corresponding second electrode 211 can be tested in real time, and according to the real-time detection of the impedance of each of the first electrodes 111 and the corresponding second electrodes 211 The impedance between the corresponding second electrodes 211 is adjusted to adjust the radio frequency energy between each first electrode 111 and the corresponding second electrode 211 to perform ablation, and the machine will alarm when the impedance reaches a certain resistance value, and the ablation is completed, so as to avoid excessive ablation and avoid excessive ablation. It solves the problem of limited depth of unilateral ablation of interventional ablation in the prior art, and it is difficult to ensure complete dehydration and degeneration of the tissue from the inside to the outside. At the same time, it solves the problem that the power of radio frequency is not easy to control. Smaller power will cause incomplete ablation and excessive power. Cause excessive ablation, tissue necrosis or even burn through, burning leakage.

During the ablation process, the impedance of the tissue to be ablated between the electrodes changes from low to high; in the first stage of ablation, the impedance of the tissue to be ablated between the electrodes gradually increases, and the RF power remains unchanged to accelerate the intracellular molecules. Vibration; in the second stage of ablation, as the impedance of the tissue to be ablated between the electrodes increases, the RF power gradually increases, and when the impedance of the tissue to be ablated between the electrodes increases to its first preset value, the RF power also increases. In the ablation stage, the cells are rapidly dehydrated to produce irreversible changes; in the third stage of ablation, as the impedance of the ablated tissue between the electrodes continues to increase, the radio frequency power is gradually reduced, so that the Ensure the completeness of ablation and prevent the phenomenon of tissue surface scarring or patient damage caused by high-power output of the radio frequency; until the impedance of the ablated tissue between the electrodes increases to its second preset value, the end of the ablation is prompted.

In this embodiment, the first electrode tip 110 includes a first magnetic member 112 , the second electrode tip 210 includes a second magnetic member 212 , and the first magnetic member 112 and the second magnetic member 212 cooperate to make the first The electrode tip 110 and the second electrode tip 210 are relatively fixed, so that each first electrode 111 of the first electrode tip 110 can be disposed opposite to the corresponding second electrode 211 of the second electrode tip 210 .

Optionally, the plurality of first magnetic members 112 are all disposed in the lumen of the first protective sheath 113 .

Optionally, as shown in FIG. 4 and FIG. 9 , both the first magnetic member 112 and the second magnetic member 212 are multiple, the first electrode tip 110 and the second electrode tip 210 are both strip-shaped, and the multiple A magnetic member 112 is arranged at intervals along the extending direction of the first electrode tip 110 , and a plurality of second magnetic members 212 are arranged at intervals along the extending direction of the second electrode tip 210 to ensure the first electrode tip 110 and the second electrode tip The overall fixation effect between the heads 210.

Optionally, each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs.

Optionally, the magnetic force of the magnetic piece is controllable and adjustable, a small magnetic force is used in the initial positioning, and a large magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible in the initial positioning and firm in the final positioning, so as to ensure the electrode assembly. The degree of fit, thereby ensuring the ablation effect.

Optionally, the first magnetic member 112 is an electromagnet; and/or the second magnetic member 212 is an electromagnet.

Optionally, each of the first magnetic member 112 and the second magnetic member 212 is 2 to 5.

Optionally, the plurality of first magnetic members 112 are all disposed in the first protective sheath 113 , and the plurality of first magnetic members 112 are disposed at intervals along the extending direction of the first protective sheath 113 . Optionally, the plurality of first magnetic members 112 and the plurality of first electrodes 111 are alternately arranged along the extending direction of the first protective sheath 113 , so that the plurality of first electrodes 111 are arranged at intervals, that is, each first magnetic member 112 is used to separate the plurality of first electrodes 111 . The corresponding two first electrodes 111 are turned on. During operation, each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs. The magnetic force of the magnetic parts is controllable and adjustable. A small magnetic force is used in the initial positioning, and a larger magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible at the initial positioning and firm after the final positioning, so as to ensure the fit of the electrodes. , thereby ensuring the ablation effect.

In this embodiment, as shown in FIG. 4 , the opposite sides of the first protective sheath 113 are provided with shielding side eaves 115 to protect the plurality of first electrodes 111 and the plurality of first magnetic fields inside the first protective sheath 113 . Each of the components 112 forms a shielding and protective effect, so as to prevent blood and the like from the epicardial tissue from entering the area between the first protective sheath 113 and the epicardium during the ablation process, thereby affecting the tightness between the first protective sheath 113 and the epicardium. , to avoid the measurement accuracy of the resistance value between the first electrode 111 and the second electrode during ablation, thereby affecting the ablation effect.

Optionally, the shielding side eave 115 is strip-shaped, and the shielding side eave 115 extends along the extending direction of the first protective sheath 113 . By setting the shielding side eave 115, the tissue fluid outside the ablation line and liquids such as normal saline can be shielded from entering the ablation site, avoiding the measurement accuracy of the resistance value between the first electrode and the second electrode during ablation, thereby affecting the ablation effect.

Optionally, the first electrode 111 and/or the first magnetic member 112 are provided with wire laying grooves 120 for accommodating wires, and the wires are used to connect with the first electrode 111; or, the wire laying grooves 120 for laying wires It is arranged on the inner wall of the first protective sheath 113 .

In this embodiment, the first electrode assembly 100 includes an operating handle 160 and a plurality of first electrode tips 110 . The number of the first electrodes 111 of the plurality of first electrode tips 110 is different from each other. A first electrode tip 110 of the heads 110 is optionally connected to the handle 160 .

The second electrode assembly 200 includes a manipulation handle 260 and a plurality of second electrode ends 210 , the number of the second electrodes 211 of the plurality of second electrode ends 210 is different, and one of the plurality of second electrode ends 210 is the first The two electrode terminals 210 are selectively connected to the manipulation handle 260 ; the plurality of second electrode terminals 210 and the plurality of first electrode terminals 110 are arranged to cooperate with each other.

In this embodiment, as shown in FIGS. 9 and 10 , the second electrode tip 210 includes a second protective sheath 214 , and the second electrode 211 is disposed on the second protective sheath 214 ; wherein, the second electrode tip 210 includes The developing member 213, the developing member 213 is disposed on the second protective sheath 214, so as to mark the position of the second electrode end 210 by the developing member 213; and/or, the second electrode 211 is made of a metal developing material, and the metal developing material includes At least one of the following materials: platinum, platinum-based alloy, tantalum, gold-plated beryllium bronze; and/or, the second protective sheath 214 is made of a developing material, and the composition of the developing material includes barium sulfate (BaSO4).

Optionally, the plurality of second magnetic members 212 and the plurality of second electrodes 211 are sleeved on the second protective sheath 214; The extension directions of the protective sheaths are staggered, so that the plurality of second electrodes 211 are arranged at intervals, that is, each second magnetic member 212 is used to separate the corresponding two second electrodes 211 .

Optionally, the plurality of second magnetic members 212 and the plurality of second electrodes 211 are both annular structures, or have cross-sectional structures such as square, V-shaped, D-shaped, and arched.

In this embodiment, the developing member 213 , the second electrode 211 with a developing function, and the second protective sheath 214 with a developing function can indicate the position of the second electrode assembly 200 when it enters the ablation site. Optionally, the number of the developing members 213 on the second electrode end 210 is 3-6, and the number of the developing members 213 may be set independently or the second electrode 211 may have a developing function. In this embodiment, the outer walls of the developing member 213 and the second protective sheath 214 are flush to prevent damage to the patient during the operation.

In this embodiment, the second electrodes 211 are arranged at intervals along the extending direction of the second protective sheath 214 , sleeved on the second protective sheath 214 , and the electrode surface is higher than the surface of the second protective sheath 214 . The developing member may be absent, or there may be a plurality of developing members 213, and the plurality of developing members 213 are arranged at intervals along the extending direction of the second protective sheath 214; The first surface part and the second surface part connected to the first surface part form the first surface part, the first surface part is a concave structure, the developing part 213 is sleeved on the first surface part, and the outer surface of the developing part 213 is connected to the second surface part. The portion is flush with or lower than the second surface portion.

During operation, the first electrode assembly 100 is first fixed on the epicardium through the positioning member, then the second electrode assembly 200 enters the heart, and the second electrode assembly 200 is placed in the endocardium through the indication of the developing member 213. At the corresponding part of the electrode assembly 100, the first pair of magnetic parts, the second pair of magnetic parts and the third pair of magnetic parts located at the first electrode end 110 and the second electrode end 210 are turned on synchronously and sequentially. At this time, two sets of electrodes Complete initial positioning. After completing the initial positioning, the two electrode assemblies then turn on the remaining magnetic parts in pairs to complete the final positioning.

Optionally, when the first electrode 111 and the second electrode 211 work, each pair of electrodes is relatively independent, that is, the number of working electrodes can be controlled.

In this embodiment, as shown in FIG. 7 , the first electrode 111 has an electrode surface 1110 disposed toward the site to be ablated, and the first protective sheath 113 has a protective sheath surface 1130 disposed toward the site to be ablated; wherein, the electrode surface 1110 is located on the The protective sheath surface 1130 is close to the side of the site to be ablated.

In this embodiment, there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; between the electrode surfaces 1110 of the multiple first electrodes 111 and the protective sheath surface 1130 The minimum distances are the same. The value range of the minimum distance between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is 0-0.5 mm. The existence of this height difference can make the first electrode fully contact the surface to be ablated to ensure the ablation effect. The height difference between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is preferably 0.2 mm.

In this embodiment, the electrode surface 1110 and the protective sheath surface 1130 are both flat surfaces.

In order to achieve cooling of the first electrode tip 110, as shown in FIG. 7, there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; At least one of the first electrodes 111 in the 111 is provided with a cooling hole 1112 for circulating a cooling fluid; and/or a cooling pipe for circulating a cooling fluid is provided in the first protective sheath 113 . In this embodiment, the cooling holes 1112 are provided for local cooling during the ablation process, so as to protect other parts other than the ablation site from being damaged. By providing cooling channels, cooling can be performed on the sides of the electrodes.

In this embodiment, at least one of the plurality of first electrodes 111 is provided with 1 to 4 cooling holes 1112 . The number of cooling holes on each first electrode 111 is 0-4 to ensure temperature control during ablation.

Optionally, as shown in FIG. 11 , the radio frequency host 310 is provided with a display screen 313 , and the display screen 313 is used to display the measured values of the tissue to be ablated between the two corresponding first electrodes 111 and the second electrodes 211 . Impedance and/or RF Power.

Optionally, the radio frequency host 310 is further provided with an ablation interface 311, the first electrode assembly 100 and the second electrode assembly 200 each include a plurality of lead assemblies, and each lead assembly includes a lead connector and a plurality of parallel connection connected to the lead connector. Lead wires, each lead wire is used to connect with the corresponding electrode; the ablation interface 311 has a first ablation interface part and a second ablation interface part, and the first ablation interface part has a plurality of lead wires for inserting the plurality of lead wires of the first electrode assembly 100. a first ablation interface, the second ablation interface part has a plurality of second ablation interfaces for inserting a plurality of lead wires of the second electrode assembly 200, so as to communicate with the corresponding The first electrode 111 and the corresponding second electrode 211 provide suitable radio frequency power.

Optionally, when the first magnetic member 112 and the second magnetic member 212 are both electromagnets, the radio frequency host 310 is further provided with an electromagnetic interface 312, and both the first electrode assembly 100 and the second electrode assembly 200 include a plurality of electromagnets. components, each electromagnet assembly includes an electromagnetic joint and a plurality of electromagnetic wires connected in parallel with the electromagnetic joint, and each electromagnetic wire is used to connect with the corresponding electromagnet; the electromagnetic interface 312 has a first electromagnetic interface part and a second electromagnetic interface part , the first electromagnetic interface part has a plurality of first magnetic interfaces for inserting a plurality of electromagnetic joints of the first electrode assembly 100 , and the second electromagnetic interface part has a plurality of electromagnetic joints for inserting a plurality of electromagnetic joints of the second electrode assembly 200 a plurality of second magnetic interfaces, so as to supply power to the corresponding first magnetic member 112 and the corresponding second magnetic member 212 through each of the first magnetic An attraction force is generated between the second magnetic members 212 .

Referring to FIGS. 13 to 16 , it can be seen that the ablation device in this embodiment has an ablation principle of the site to be ablated, and can reflect the ablation range 330 of the ablation device.

From the above description, it can be seen that the above-mentioned embodiments of the present disclosure achieve the following technical effects:

In the radio frequency ablation device of the present disclosure, the radio frequency ablation device includes a first electrode assembly 100 having a first electrode tip 110 and a radio frequency host 310. The first electrode tip 110 includes a first protective sheath 113 and is disposed on the first protective sheath 113. The plurality of first electrodes 111 of the sheath 113; the radio frequency host 310 is connected to the plurality of first electrodes 111 to energize each of the first electrodes 111; and the first protective sheath 113 is a tube body, and the plurality of first electrodes 111 are provided In the lumen of the first protective sheath 113 and at intervals along the extending direction of the first protective sheath 113; that is, a plurality of first electrodes 111 act on their corresponding tissues at the same time to form a complete ablation line, thereby realizing Good ablation effect and improve ablation efficiency.

The ablation device is simultaneously connected with the first electrode assembly and the second electrode assembly, and the first electrode of the first electrode assembly and the second electrode of the second electrode assembly are disposed opposite to each other, so as to be located on the first electrode through the first electrode and the second electrode pair The tissue to be ablated between the second electrode and the second electrode is ablated. When in use, the first electrode assembly and the second electrode assembly are used as epicardial electrodes and endocardial electrodes, respectively, so that the first electrode assembly and the second electrode assembly act on the epicardium and the endocardium, respectively, to achieve Ablation of the epicardium and endocardium at the same time solves the problems of dynamic ablation in cardiac surgery, but the surgical ablation is relatively traumatic and the postoperative recovery is slow. It also solves the problem of constant medical interventional ablation energy and inability to adjust the output power according to the ablation effect in a timely manner, resulting in excessive ablation. Burning or impermeability of the wall; thus achieving good ablation effect and improving ablation efficiency; it can be seen that the use of the ablation device can solve the problem of unsatisfactory ablation effect of the ablation device in the prior art.

For ease of description, spatially relative terms, such as "on", "over", "on the surface", "above", etc., may be used herein to describe what is shown in the figures. The spatial positional relationship of one device or feature shown to other devices or features. It should be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "above" or "over" other devices or features would then be oriented "below" or "over" the other devices or features under other devices or constructions". Thus, the exemplary term "above" can encompass both an orientation of "above" and "below." The device may also be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptions used herein interpreted accordingly.

It should be noted that the terminology used herein is for the purpose of describing specific embodiments only, and is not intended to limit the exemplary embodiments according to the present disclosure. As used herein, unless the context clearly dictates otherwise, the singular is intended to include the plural as well, furthermore, it is to be understood that when the terms "comprising" and/or "including" are used in this specification, it indicates that There are features, steps, operations, devices, components and/or combinations thereof.

It should be noted that the terms "first", "second" and the like in the description and claims of the present disclosure and the above drawings are used to distinguish similar objects, and are not necessarily used to describe a specific sequence or sequence. It is to be understood that the data so used are interchangeable under appropriate circumstances such that the embodiments of the disclosure described herein can, for example, be practiced in sequences other than those illustrated or described herein. Furthermore, the terms "comprising" and "having" and any variations thereof, are intended to cover non-exclusive inclusion, for example, a process, method, system, product or device comprising a series of steps or units is not necessarily limited to those expressly listed Rather, those steps or units may include other steps or units not expressly listed or inherent to these processes, methods, products or devices.

The above descriptions are only preferred embodiments of the present disclosure, and are not intended to limit the present disclosure. For those skilled in the art, the present disclosure may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present disclosure shall be included within the protection scope of the present disclosure.

Claims (33)

An ablation device comprising: A first electrode assembly (100), the first electrode assembly (100) includes a first electrode tip (110), the first electrode tip (110) includes a first protective sheath (113) and is disposed on the a plurality of first electrodes (111) of the first protective sheath (113); Wherein, the first protective sheath (113) is strip-shaped, and the plurality of first electrodes (111) are arranged at intervals along the extending direction of the first protective sheath (113). The ablation device of claim 1, wherein the first protective sheath (113) is made of a flexible material. The ablation device of claim 1 or 2, wherein the first electrode tip (110) further comprises: A positioning member (114) is provided on the first protective sheath (113), and the first electrode tip (110) is positioned on the epicardium through the positioning member (114). The ablation device of claim 3, wherein, The positioning member (114) is a balloon structure, and the positioning member (114) is disposed on the outer wall of the first protective sheath (113); or When the positioning member (114) is in a retracted state, the positioning member (114) is located inside the first protective sheath (113), and when the positioning member (114) is in an expanded state, the positioning member (114) is located inside the first protective sheath (113) At least part of (114) protrudes from the inside of the first protective sheath (113) to the outside of the first protective sheath (113). The ablation device according to claim 3 or 4, wherein there are multiple positioning members (114), and a plurality of positioning members (114) are arranged at intervals along the extending direction of the first protective sheath (113) and are Independent control. The ablation device according to any one of claims 3 to 5, wherein the positioning member (114) is strip-shaped, square, or circular, and the positioning member (114) is along the first protective sheath The extension direction of (113) extends. The ablation device of any one of claims 1 to 6, further comprising: A second electrode assembly (200), the second electrode assembly (200) includes a second electrode tip (210), the second electrode tip (210) includes a plurality of second electrodes (211), a plurality of all The second electrodes (211) are arranged at intervals along the extending direction of the second electrode tip (210); Wherein, the plurality of first electrodes (111) and the plurality of second electrodes (211) are arranged in cooperation with each other, and the second electrode tip (210) is configured to be arranged on the endocardium to pass through the The first electrode (111) and the second electrode (211) ablate the tissue to be ablated between the first electrode (111) and the second electrode (211). The ablation device of claim 7, further comprising: an ablation circuit (320), the first electrode (111) and the second electrode (211) are both provided on the ablation circuit (320) to test each of the first electrodes (111) and the corresponding The impedance between the second electrodes (211) adjusts the radio frequency energy between the first electrode (111) and the second electrode (211) for ablation. The ablation device according to claim 7 or 8, wherein the first electrode tip (110) comprises a first magnetic member (112), and the second electrode tip (210) comprises a second magnetic member (212) ), the first magnetic member (112) and the second magnetic member (212) are matched, so that the first electrode end (110) and the second electrode end (210) are relatively fixed. The ablation device according to claim 9, wherein the first magnetic member (112) and the second magnetic member (212) are multiple, and the first electrode tip (110) and the first magnetic member (110) The two electrode ends (210) are both strip-shaped, a plurality of the first magnetic parts (112) are arranged at intervals along the extending direction of the first electrode end (110), and a plurality of the second magnetic parts (212) ) are arranged at intervals along the extending direction of the second electrode tip (210). The ablation device according to claim 10, wherein a plurality of the first magnetic parts (112) and a plurality of the first electrodes (111) are alternately arranged at intervals, and the plurality of the second magnetic parts (212) are arranged with A plurality of the second electrodes (211) are alternately arranged at intervals. The ablation device according to any one of claims 9 to 11, wherein the adjacent first electrodes (111) and the first magnetic member (112) are insulated and provided, and the adjacent first electrodes (111) are insulated from each other. The two electrodes (211) are insulated from the second magnetic member (212). The ablation device according to any one of claims 9 to 12, wherein the opposite surfaces between the adjacent first electrodes (111) and the first magnetic member (112) are sprayed with insulating paint, Or an insulating separator is provided between the adjacent first electrodes (111) and the first magnetic member (112); the adjacent second electrodes (211) and the second magnetic member (212) ) are sprayed with insulating paint, or an insulating separator is arranged between the adjacent second electrodes (211) and the second magnetic member (212). The ablation device according to any one of claims 9 to 12, wherein the outer surfaces of the first magnetic member (112) and the second magnetic member (212) are both coated with an insulating layer. The ablation device of any one of claims 9 to 14, wherein the ablation device comprises a first electrode circuit, a first magnetic circuit, a second electrode circuit, a second magnetic circuit, the first electrode circuit and The first electrode (111) is connected, the first magnetic circuit is connected to the first magnetic member (112), the second electrode circuit is connected to the second electrode (211), and the second magnetic circuit is connected to the second electrode (211). A circuit is connected to the second magnetic member (212). The ablation device according to any one of claims 1 to 15, wherein the energization circuits of the two first electrodes (111) are independently arranged to form a mapping electrode pair, so as to use the energization circuits to detect the post-ablation Electrical signaling of the tissue to be ablated (340). The ablation device according to any one of claims 7 to 16, wherein the energization circuits of the two second electrodes (211) are independently arranged to form a mapping electrode pair, so as to use the energization circuits to detect the ablation Transmission of electrical signals of the tissue (340) to be ablated; and/or, the energization circuits of the first electrode (111) and the second electrode (211) are independently arranged to form a mapping electrode pair, so as to utilize the energization The circuit detects the transmission of electrical signals after ablation of the tissue to be ablated (340). The ablation device of any one of claims 7 to 17, wherein the first electrode tip (110) and the second electrode tip are both plural. The ablation device according to any one of claims 1 to 18, wherein two opposite sides of the first protective sheath (113) are provided with shielding side eaves (115). The ablation device according to any one of claims 1 to 19, wherein a plurality of first electrodes (111) included in the first electrode tip (110) are provided in isolation. The ablation device according to any one of claims 1 to 20, wherein the energization circuits of the plurality of first electrodes (111) are independently provided to individually control each of the first electrodes (111). The ablation device according to any one of claims 1 to 21, wherein two adjacent first electrodes (111) of the same first electrode tip (110) form an electrode pair, and two electrodes arranged at intervals The two electrode pairs are mated relative to each other for testing electrical signal transfer of the tissue between the two electrode pairs. The ablation device according to any one of claims 1 to 22, wherein two adjacent first electrodes (111) in different first electrode tips (110) form an electrode pair, and the electrodes The polarities of the two first electrodes (111) of the pair are opposite to detect electrical signal transfer of the tissue between the two first electrodes (111) of the electrode pair. The ablation device according to any one of claims 1 to 23, wherein the first electrode (111) has an electrode surface (1110) arranged towards the tissue to be ablated, the first protective sheath (113) There is a protective sheath surface (1130) disposed toward the device to be ablated; wherein, the electrode surface (1110) is located on the side of the protective sheath surface (1130) close to the tissue to be ablated. The ablation device according to claim 24, wherein there are a plurality of the first electrodes (111), and the plurality of the first electrodes (111) are arranged at intervals along the extending direction of the first electrode tip (110) ; The minimum distances between the electrode surfaces (1110) of the plurality of first electrodes (111) and the protective sheath surface (1130) are all the same. The ablation device of claim 24 or 25, wherein both the electrode face (1110) and the protective sheath face (1130) are planar. The ablation device according to any one of claims 1 to 26, wherein there are a plurality of the first electrodes (111), and the plurality of the first electrodes (111) are along the first electrode tip (110) ) are arranged at intervals in the extending direction of the plurality of first electrodes (111); at least one of the first electrodes (111) of the plurality of first electrodes (111) is provided with cooling holes (1112) for circulating cooling fluid; and/or the The first protective sheath (113) is provided with a cooling pipe for circulating the cooling fluid. The ablation device according to claim 27, wherein at least one of the first electrodes (111) among the plurality of first electrodes (111) is provided with 1 to 4 cooling holes (1112). The ablation device according to claims 8 to 28, wherein the second electrode tip (210) comprises a second protective sheath (214), and the second electrode (211) is disposed in the second protective sheath ( 214) on; The second electrode (211) is made of a metal developing material, and the metal developing material includes at least one of the following materials: platinum, platinum-based alloy, tantalum, gold-plated beryllium bronze; and/or, The second protective sheath (214) is made of a developing material, and the components of the developing material include barium sulfate. The ablation device according to claim 29, wherein the second electrodes (211) are arranged at intervals along the extending direction of the second protective sheath (214), and the second electrodes (211) are sleeved on the second protective sheath (214). On the sheath (214), the electrode surface of the second electrode (211) is located outside the surface of the second protective sheath (214). A radio frequency ablation device, comprising a radio frequency host (310) and an ablation device connected to the radio frequency host (310), wherein the ablation device is the ablation device according to any one of claims 1 to 30. The radiofrequency ablation device of claim 31, wherein: The radio frequency host (310) is connected to the plurality of first electrodes (111) to energize each of the first electrodes (111); The plurality of first electrodes (111) are all arranged on the first protective sheath (113) and are independently controlled. The radiofrequency ablation device of claim 32, wherein the radiofrequency ablation device further comprises: A second electrode assembly (200), the second electrode assembly (200) includes a second electrode tip (210), the second electrode tip (210) includes a plurality of second electrodes (211), a plurality of all The second electrodes (211) are arranged at intervals along the extending direction of the second electrode tip (210); the radio frequency host (310) is connected to the plurality of second electrodes (211), so as to provide each of the second electrodes (211) The two electrodes (211) are energized; Wherein, the plurality of first electrodes (111) and the plurality of second electrodes (211) are arranged in cooperation with each other, and the second electrode tip (210) is configured to be arranged on the endocardium to pass through the The first electrode (111) and the second electrode (211) ablate the site to be ablated located between the first electrode (111) and the second electrode (211).

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