Electrode assembly for local ablation, ablation assembly and ablation instrument

Abstract

The utility model provides an electrode assembly used for local ablation, an ablation assembly and an ablatometer, the electrode assembly used for an ablation catheter comprises a hollow catheter body and a built-in electrode, the whole structure of the built-in electrode is located in the catheter body; and the external electrode is arranged on the outer wall surface of the tube body. The built-in electrode is arranged on the inner side of the electrode assembly tube body, so that the ablation width is reduced while the ablation depth is ensured, an electric field can be better concentrated at a target tissue in contact with the built-in electrode, an ablation area is formed in a local tissue, and the influence of ablation at a non-target tissue is reduced; the ablation area of the built-in electrode is more gathered, external radiation is little, stimulation is small, and the muscular fibrillation phenomenon is reduced while the ablation depth is guaranteed.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, and particularly to an electrode assembly, an ablation assembly and an ablation instrument for local ablation. Background Art

[0002] Atrial fibrillation (AF) is one of the common clinical arrhythmias. AF not only affects cardiac function, but is also associated with serious complications and death. The risk of stroke in patients with AF is 6 times that of non-AF patients.

[0003] With the rapid development of ablation technology, it has currently become a safe and effective method for treating AF. Among them, radiofrequency ablation uses radiofrequency energy to heat tissues, resulting in coagulative necrosis of tissues. However, the heating characteristics of radiofrequency ablation lack tissue selectivity and may damage the surrounding structures of the atrium (such as the phrenic nerve and esophagus). Pulsed Field Ablation (PFA) uses multiple short-duration, high-voltage electrical pulses to release ablation energy, which can generate irreversible nanoscale micropores on the cell membrane, leading to cell death, thereby achieving the purpose of ablating tissues. PFA has the characteristics of myocardial tissue selectivity, non-temperature effect ablation, rapid energy release, controllable damage depth, and does not require complete apposition. While effectively and rapidly achieving myocardial damage, it can reduce damage to surrounding tissues such as the esophagus and phrenic nerve to a certain extent.

[0004] In current common pulsed ablation catheters, although the ablation effect is directly proportional to the pulse parameters, the pulse parameters have a certain threshold effect. Increasing the pulse dose will lead to an increase in the ablation width, affecting other non-ablation tissues, and excessive pulse doses will also produce thermal effects, and the muscle tremor phenomenon is obvious. Summary of the Utility Model

[0005] The technical problem to be solved by the utility model is to overcome the defect that in the prior art, increasing the pulse measurement of the pulsed ablation assembly leads to an increase in the ablation width and an obvious muscle tremor phenomenon, and to provide an electrode assembly, an ablation assembly and an ablation instrument for local ablation.

[0006] The utility model solves the above technical problem through the following technical solutions:

[0007] In the first aspect, there is provided an electrode assembly for local ablation, including:

[0008] A hollow tube body;

[0009] An internal electrode, all structures of which are located inside the tube body;

[0010] An external electrode, disposed on the outer wall surface of the tube body.

[0011] Optionally, the built-in electrode is funnel-shaped, with the first opening of the built-in electrode close to the opening of the tube body and the second opening of the built-in electrode far from the opening of the tube body, and the first opening is larger than the second opening;

[0012] Optionally, the diameter of the first opening of the built-in electrode ranges from 0.5 mm to 2.8 mm;

[0013] Optionally, the diameter of the second opening of the built-in electrode ranges from 0.25 mm to 2.7 mm;

[0014] Optionally, the length of the built-in electrode is 1 mm to 6 mm;

[0015] Optionally, the distance between the first opening of the built-in electrode and the opening of the tube body ranges from 0.2 mm to 2 mm.

[0016] Optionally, the shape of the external electrode is annular;

[0017] Optionally, the outer diameter of the external electrode ranges from 0.7 mm to 3.0 mm;

[0018] Optionally, the length of the external electrode ranges from 0.5 mm to 8 mm;

[0019] Optionally, the number of the external electrodes is at least 2, and the external electrodes are arranged at intervals around the axial direction of the tube body, and the external electrodes are separated by insulators, and the lengths of the external electrodes are not completely the same,

[0020] Optionally, the number of the external electrodes is 4. The distance between the first external electrode and the opening of the tube body ranges from 0.5 mm to 2 mm, the distance between the second external electrode and the first external electrode ranges from 2 mm to 8 mm, the distance between the third external electrode and the second external electrode ranges from 1 mm to 5 mm, and the distance between the fourth external electrode and the third external electrode ranges from 1 mm to 5 mm.

[0021] Optionally, the electrode assembly further includes a needle electrode;

[0022] The built-in electrode is a hollow structure, the needle electrode penetrates through the built-in electrode, and the built-in electrode and the needle electrode are separated by an insulator.

[0023] Optionally, the electrode assembly further includes a first catheter and a connecting wire;

[0024] One end of the needle electrode is sleeved in the first catheter. The first catheter contains a connection line connected to the needle electrode, and the needle electrode is connected to an external socket through the connection line. The connection line is used to drive the needle electrode to move relative to the built-in electrode under an external force;

[0025] Optionally, the diameter of the needle electrode is 0.1 mm - 2 mm;

[0026] Optionally, the length of the needle electrode is 1 mm - 20 mm.

[0027] Optionally, the electrode assembly further includes a limiting component clamped at the second opening of the built-in electrode. The limiting component is a hollow structure, the needle electrode penetrates through the limiting component, and the inner diameter of the limiting component is larger than the outer diameter of the needle electrode and smaller than the outer diameter of the first catheter;

[0028] Optionally, the inner diameter of the limiting component ranges from 0.05 mm to 1.0 mm;

[0029] Optionally, the wall thickness of the limiting component ranges from 0.05 mm to 0.35 mm.

[0030] In a second aspect, an ablation assembly is provided, including an outer tube and the electrode assembly according to any one of the above, and the electrode assembly is connected to the outer tube.

[0031] Optionally, the ablation assembly further includes a second catheter placed inside the tube body. One end of the second catheter is connected to the end face at the second opening of the built-in electrode, and the other end of the second catheter serves as a saline injection port.

[0032] Optionally, the outer tube is a multi-lumen tube, and each cavity is provided with a connection line connected to the built-in electrode and the external electrode.

[0033] Optionally, the ablation assembly further includes a handle. The outer end of the second catheter is a bendable section, the bendable section is connected to the electrode assembly, and the bendable section is connected to a bending control knob on the handle through a connection line located inside the second catheter.

[0034] In a third aspect, an ablation instrument is provided, including an energy output device. It is characterized in that it further includes the ablation assembly according to any one of the above, and the energy output device is connected to the ablation assembly.

[0035] Optionally, the ablation instrument further includes:

[0036] An R-wave detection device, which is used for R-wave gating in the ablation mode;

[0037] Optionally, it further includes a back reference electrode, and the back reference electrode is connected to the energy output device.

[0038] Based on the common knowledge in the art, the above preferred conditions can be combined arbitrarily to obtain various preferred examples of the present invention.

[0039] The positive and progressive effects of the present invention are as follows: By installing the built-in electrode inside the tube body of the electrode assembly, while ensuring the ablation depth, the ablation area can be made more concentrated, the ablation width can be reduced, so that the electric field can be better concentrated at the target tissue in contact with the built-in electrode, forming an ablation area locally in the tissue, reducing the influence of ablation at non-target tissues. In addition, the ablation area of the built-in electrode is more concentrated, with less external radiation and less stimulation, reducing the muscle tremor phenomenon while ensuring the ablation depth. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 FIG. is a schematic structural diagram of an electrode assembly for local ablation provided by an exemplary embodiment of the present invention;

[0041] Figure 2 FIG. is a schematic structural diagram of another electrode assembly for local ablation provided by an exemplary embodiment of the present invention;

[0042] Figure 3 FIG. is a schematic structural diagram of a built-in electrode provided by an exemplary embodiment of the present invention;

[0043] Figure 4 FIG. is a schematic diagram of the ablation film effect of different built-in electrodes provided by an exemplary embodiment of the present invention;

[0044] Figure 5 FIG. is a schematic structural diagram of another electrode assembly for local ablation provided by an exemplary embodiment of the present invention;

[0045] Figure 6 FIG. is a schematic structural diagram of another electrode assembly for local ablation provided by an exemplary embodiment of the present invention;

[0046] Figure 7 FIG. is a schematic structural diagram of the needle electrode part in another electrode assembly for local ablation provided by an exemplary embodiment of the present invention;

[0047] Figure 8 FIG. is a schematic structural diagram of another electrode assembly for local ablation provided by an exemplary embodiment of the present invention;

[0048] Figure 9 FIG. is a schematic cross-sectional structural diagram of an ablation assembly provided by an exemplary embodiment of the present invention;

[0049] Figure 10Schematic diagram of the structure of an ablation instrument provided by an exemplary embodiment of the present utility model;

[0050] Figure 11 Control method for an electrode assembly provided by an exemplary embodiment of the present utility model;

[0051] Figure 12 Schematic diagram of the field strength threshold of a control method for an electrode assembly provided by an exemplary embodiment of the present utility model;

[0052] Figure 13 Schematic diagram of the field strength threshold of another control method for an electrode assembly provided by an exemplary embodiment of the present utility model;

[0053] Figure 14 Schematic diagram of the field strength threshold of another control method for an electrode assembly provided by an exemplary embodiment of the present utility model;

[0054] Figure 15 Schematic diagram of the relationship between different discharge modes and ablation depth and ablation volume provided by an exemplary embodiment of the present utility model;

[0055] Figure 16 Schematic diagram of the relationship between different discharge modes and the ratio of ablation depth to width provided by an exemplary embodiment of the present utility model;

[0056] Figure 17 Schematic diagram of the field strength threshold of a control method for an electrode assembly including a needle electrode provided by an exemplary embodiment of the present utility model;

[0057] Figure 18 Schematic diagram of the relationship between ablation depth and ablation width and the length of the needle electrode provided by an exemplary embodiment of the present utility model;

[0058] Figure 19 Schematic diagram of the relationship between ablation depth and ablation width and the diameter of the needle electrode provided by an exemplary embodiment of the present utility model;

[0059] Figure 20 Schematic diagram of the fitting plane of ablation depth with the length and diameter of the needle electrode provided by an exemplary embodiment of the present utility model;

[0060] Figure 21 Schematic diagram of the structure of an electronic device shown by an exemplary embodiment of the present utility model. Detailed implementation manners

[0061] The present utility model will be further described below by way of embodiments, but the present utility model is not limited to the scope of the described embodiments.

[0062] In the embodiments of the present utility model, prefix words such as "first" and "second" are only used to distinguish different described objects, and have no restrictive effect on the position, order, priority, quantity, content, etc. of the described objects. In the embodiments of the present utility model, the use of prefix words such as ordinal numbers for distinguishing described objects does not constitute a limitation on the described objects. For the statements of the described objects, refer to the description in the claims or the context of the embodiments. It should not constitute an unnecessary limitation due to the use of such prefix words. In addition, in the description of this embodiment, unless otherwise specified, the meaning of "a plurality" is two or more.

[0063] Figure 1 The following is a schematic structural diagram of an electrode assembly for local ablation provided by an exemplary embodiment of the present utility model, wherein the electrode assembly includes:

[0064] A hollow tube body 101, with an internal electrode 102 and an external electrode 103 disposed therein.

[0065] In this embodiment, the tube body 101 is a single-chamber tube, and the material is a polymer material such as LCP or PEEK. The internal electrode 102 is located inside the tube body 101 and can adopt various shapes. It can be annularly arranged on the inner wall of the tube body 101, or can adopt an elliptical groove structure, or can also adopt a concentric circle structure, etc. This embodiment does not make any restrictions. The internal electrode 102 is bonded to the tube body 101 through an insulating material, and the external electrode 103 is disposed on the outer wall surface of the tube body 101. Since the internal electrode 102 is installed inside the hollow tube body 101 of the electrode assembly, it forms a discharge circuit with the external electrode 103. Among them, the materials of the internal electrode 102 and the external electrode 103 are both metals such as platinum-iridium alloy or gold.

[0066] Specifically, during the pulsed electric field ablation process, the ablation instrument transmits pulses to the electrode assembly to form ablation lesions at target sites such as abnormal cardiac tissues like atrial fibrillation and tumors. The electrode assembly directly acts on the target site with high-intensity and short-time electric field pulses, and destroys the cell membrane through the electroporation effect, causing apoptosis or necrosis of the cells at the target site. Different electrode assemblies and pulses determine the ablation volume.

[0067] In this embodiment, installing the internal electrode inside the tube body of the electrode assembly can ensure the ablation depth while making the ablation area more concentrated, reducing the ablation width, enabling the electric field to be better concentrated at the target tissue in contact with the internal electrode, forming an ablation area locally in the tissue, reducing the influence of ablation at non-target tissues. In addition, the ablation area of the internal electrode is more concentrated, with less external radiation and less stimulation, reducing the muscle tremor phenomenon while ensuring the ablation depth.

[0068] Figure 2Another structural schematic diagram of an electrode assembly for local ablation provided by an exemplary embodiment of the present utility model. The built-in electrode 102 is funnel-shaped. The first opening of the built-in electrode 102 is close to the opening of the tube body 101, and the second opening of the built-in electrode 102 is far from the opening of the tube body 101. The first opening is larger than the second opening.

[0069] Specifically, Figure 3 It is a structural schematic diagram of the built-in electrode 102. The value range of the diameter of the first opening of the built-in electrode 102 is 0.5 mm to 2.8 mm; the value range of the diameter of the second opening of the built-in electrode 102 is 0.25 mm to 2.7 mm; the length of the built-in electrode 102 is 1 mm to 6 mm; the value range of the distance between the first opening of the built-in electrode 102 and the opening of the tube body 101 is 0.2 mm to 2 mm.

[0070] As Figure 4 shown, under the same pulse energy, for three different built-in electrodes, different types of built-in electrodes have different effects on the ablation depth. Using the funnel-shaped built-in electrode with the first opening larger than the second opening in this embodiment can provide an ablation depth of 5.5 mm under the same pulse, while using the built-in electrode with the second opening larger than the first opening has an ablation depth of 4.75 mm. The cylindrical built-in electrode with the first opening equal to the second opening can provide an ablation depth of 5.0 mm under the same pulse. Thus, it can be seen that the funnel-shaped built-in electrode with the first opening larger than the second opening in this embodiment can make the ablation area more concentrated and the ablation depth deeper.

[0071] In this embodiment, using the funnel-shaped built-in electrode can make the ablation area more concentrated and provide a deeper ablation depth under the same pulse. At the same time, it can use less pulse energy at the same ablation depth, radiate less externally, cause less stimulation, and also reduce the thermal effect of the electrode assembly and reduce the muscle tremor phenomenon.

[0072] In one embodiment, the electrode assembly includes multiple built-in electrodes 102, and the shapes of the respective built-in electrodes can be the same or different. Refer to Figure 2 , in which, one built-in electrode is funnel-shaped and the other built-in electrode is annular, and is arranged on the inner side of the tube body 101. The multiple built-in electrodes 102 serve as discharge electrodes, and discharge as a whole with the most distal built-in electrode 102, which can further increase the discharge area.

[0073] Figure 5 Another structural schematic diagram of an electrode assembly for local ablation provided by an exemplary embodiment of the present utility model. The shape of the external electrode is annular.

[0074] Specifically, the shape of the external electrode is annular, and the number of external electrodes is not limited.

[0075] In one embodiment, when the number of external electrodes is at least two, the external electrodes are arranged at intervals around the axial direction of the tube body, and the external electrodes are separated by insulators, and the lengths of the external electrodes are not completely the same.

[0076] Specifically, the external electrodes are arranged on the outer side of the tube body 101, and there is at least one internal electrode 102 inside the tube body 101. Two holes are opened at the second opening of the internal electrode 102, and a pull wire 208 is arranged in the holes for positioning the internal electrode 102. The distal insulator 205 connects the first opening of the internal electrode 102 and the tube body 101 by bonding, and connects the second opening of the internal electrode 102 and the tube body 101 through an insulating material 206. The insulating material 206 can be a PI tube.

[0077] Taking the case where there are four external electrodes as an example, the external electrodes include a first external electrode 201, a second external electrode 202, a third external electrode 203, and a fourth external electrode 204. The outer diameter value of the external electrode is 0.7 mm to 3.0 mm; the length of the first external electrode 201 is 0.5 mm to 3 mm, the length of the second external electrode 202 is 1 mm to 8 mm, and the lengths of the third external electrode 203 and the fourth external electrode 204 are 1 mm to 3 mm. Among them, the value range of the distance between the first external electrode 201 and the opening of the tube body 101 is 0.5 mm to 2 mm, the value range of the distance between the second external electrode 202 and the first external electrode 201 is 2 mm to 8 mm, the value range of the distance between the third external electrode 203 and the second external electrode 202 is 1 mm to 5 mm, and the value range of the distance between the fourth external electrode 204 and the third external electrode 203 is 1 mm to 5 mm. The materials of the external electrodes are all metals such as platinum-iridium alloy or gold.

[0078] In this embodiment, by setting a plurality of external electrodes, the plurality of external electrodes and the internal electrode can form a variety of different discharge circuits, which can provide different ablation depths, and different discharge methods can be adopted according to specific ablation targets to perform local ablation on the ablation targets, improving the flexibility of the operation.

[0079] Figure 6 FIG. is a schematic structural diagram of another electrode assembly for local ablation provided by an exemplary embodiment of the present invention, wherein the electrode assembly further includes a needle electrode 301;

[0080] The internal electrode 102 is a hollow structure, the needle electrode 301 penetrates through the internal electrode, and the internal electrode 102 and the needle electrode 301 are separated by an insulator.

[0081] Specifically, the built-in electrode 102 has a hollow structure with a diameter of 0.25 mm to 2.7 mm. The needle electrode 301 is of a separable design and can be separated from the electrode assembly. When ablating at a thick part of the ventricular tissue or a hypertrophic myocardium part, etc., the needle electrode 301 passes through the hollow structure and penetrates out of the built-in electrode 102, pierces into the tissue, and deeply performs ablation.

[0082] In this embodiment, the needle electrode serves as a supplementary electrode and can ablate tissues of a certain thickness, forming multiple different ablation schemes with the previous electrode assembly, and can provide corresponding ablation strategies for tissues of different thicknesses.

[0083] Figure 7 FIG. is a schematic structural diagram of a part of the needle electrode in another electrode assembly for local ablation provided by an exemplary embodiment of the present invention. The electrode assembly further includes a first catheter 302 and a connecting wire.

[0084] One end of the needle electrode is sleeved in the first catheter 302. The first catheter 302 contains a connecting wire connected to the needle electrode 301, and the needle electrode is connected to an external socket through the connecting wire. The connecting wire is used to drive the needle electrode to move relative to the built-in electrode under an external force.

[0085] Specifically, the material of the needle electrode 301 can be selected as stainless steel. The diameter of the needle electrode 301 is 0.1 mm to 2 mm, and the length of the needle electrode 301 is 1 mm to 20 mm. One end of the needle electrode 301 is sleeved in the first catheter 302 and is connected by an adhesive method. The first catheter 302 can be a PI tube. One end of the first catheter 302 is coated in another catheter 304. The connecting wire of the needle electrode 301 passes through the inside of the first catheter 302 and the other catheter 304 and is connected to an external socket 305. The external socket 305 is connected to the energy output port of the ablation instrument through a tail wire to release ablation energy at the target site. As Figure 8 shown, the connecting wire of the needle electrode controls the axial movement distance of the needle electrode 301 inside the built-in electrode 102 under the action of an external force.

[0086] In this embodiment, the needle electrode can move in the electrode assembly through a wire, controlling the depth of penetration of the needle electrode into the tissue, and by connecting to the energy output port of the ablation instrument, adjusting the ablation depth and volume according to the depth and pulse intensity to target different ablation targets.

[0087] In one embodiment, the electrode assembly further includes a limiting component 303 clamped at the second opening of the built-in electrode 102. The limiting component 303 has a hollow structure. The needle electrode 301 penetrates through the limiting component 303. The inner diameter of the limiting component 303 is larger than the outer diameter of the needle electrode 301 and smaller than the outer diameter of the first catheter 302.

[0088] In one embodiment, the inner diameter of the position-limiting component 303 ranges from 0.05 mm to 1.0 mm;

[0089] In one embodiment, the wall thickness of the position-limiting component 303 ranges from 0.05 mm to 0.35 mm.

[0090] Specifically, to control the axial movement distance of the needle electrode 301 within the built-in electrode 102, a position-limiting component 303 for the needle electrode 301 is added inside the electrode assembly. As Figure 6 shown, inside the inner side of the second opening of the built-in electrode 102, the position-limiting component 303 is fixedly connected to the built-in electrode 102 by bonding. The inner diameter of the position-limiting component 303 is from 0.05 mm to 1.0 mm, and the wall thickness of the position-limiting component 303 is from 0.05 mm to 0.35 mm; the inner diameter of the position-limiting component 303 is greater than the outer diameter of the needle electrode 301 and less than the outer diameter of the first catheter 302. The outer diameter of the position-limiting component 303 is slightly less than the inner diameter of the second opening of the built-in electrode 102. The position-limiting component 303 is made of an insulating material.

[0091] In this embodiment, when the needle electrode moves, when the first catheter contacts the position-limiting component, the position-limiting component restricts the continuous movement of the needle electrode, making the displacement of the needle electrode more controllable.

[0092] Figure 9 FIG. is a schematic cross-sectional structure diagram of an ablation assembly provided by an exemplary embodiment of the present invention, including an outer tube and the electrode assembly of any one of the above, and the electrode assembly is connected to the outer tube.

[0093] Specifically, the outer tube is a multi-lumen tube, and each cavity is provided with connection wires connected to the built-in electrode and the external electrode. It includes a reinforced composite tube 401 that carries all components such as wires, PI tubes, saline tubes, and sensor wires. The outer layer of the composite tube 401 is a biocompatible polymer material such as Pebax (nylon elastomer), nylon, or TPU (thermoplastic polyurethane). The inside of the composite tube 401 also includes a plurality of PI tubes 402. Wires 403 of the external electrode, sensor connection wires 404, and safety pull wires 208 of the built-in electrode 102 are distributed inside the PI tubes 402.

[0094] In this embodiment, by connecting multiple wires and sensor connection wires inside the outer tube to the electrode assembly, a pulse can be applied to the electrode assembly at the front end of the ablation assembly for local ablation.

[0095] In one embodiment, the ablation assembly further includes a second catheter 207. The second catheter 207 is placed inside the tube body 101. One end of the second catheter 207 is connected to the end face of the second opening of the built-in electrode 102, and the other end of the second catheter 207 serves as a saline injection port.

[0096] As Figure 5As shown, one end of the second catheter 207 is connected to the second opening part of the built-in electrode 102 by bonding to form a liquid channel through which normal saline can be introduced for cooling or liquid medicine can be injected for treatment. As Figure 9 As shown, inside the second catheter 207 is the first catheter 302, and inside the first catheter 302 is the connection wire 405 of the needle electrode. The other end of the second catheter 207 is connected to a handle with an external Luer connector. Through the Luer connector, the connection wire 405 or normal saline can be introduced into the second catheter 207. The connection wire 405 of the needle electrode enters the ablation assembly through the saline perfusion port and moves along the inside of the second catheter 207 until the needle electrode 301 extends out of the internal built-in electrode 102.

[0097] In this embodiment, the second catheter is connected to a saline pipe, and normal saline is perfused into the distal electrode assembly through the saline pipe to avoid the formation of blood clots. In addition, the guide wire inside the second catheter can enter the catheter through the saline perfusion port to control the movement of the needle electrode.

[0098] In one embodiment, the ablation assembly further includes a handle. The outer end of the second catheter is a bendable section, which is connected to the electrode assembly. The bendable section is connected to a bending control knob on the handle through a connection wire located inside the second catheter.

[0099] Specifically, the composite tube 401 contains two channels, each of which contains a pulling wire 406. The distal end of the pulling wire is connected to the bendable section of the outer tube to control the bilateral bending of the bendable section, which is used to control the bending of the ablation assembly.

[0100] Figure 10 The figure is a schematic structural diagram of an ablation instrument provided for an exemplary embodiment of the present invention, including an energy output device, characterized by further including the ablation assembly according to any one of the above, and the energy output device is connected to the ablation assembly.

[0101] Specifically, the ablation instrument is used for local ablation of the atrium to generate deeper ablation lesions to achieve the treatment effect. The system mainly includes an ablation instrument, an ablation component, and a connecting tail wire 8 between the ablation instrument and the ablation component. The electrode assembly 1 is connected to the handle 5 through the outer tube 3; a bending control knob 4 is arranged on the handle 5 and is connected to the bendable section 2 on the outer tube 3 to control the two-way bending of the bendable section 2; the handle 5 also includes an electrode socket 7, which is connected to the ablation instrument and is used to deliver ablation energy to the distal electrode assembly 1 to form an ablation lesion at the target site; the handle 5 also includes a saline perfusion port 6, which is used to perfuse saline to the electrode assembly 1. The connecting wire of the needle electrode is connected to an external socket, and the socket is connected to the ablation instrument through the connecting tail wire 8 to release ablation energy at the target site. The ablation instrument also includes an energy output device 10, which is provided with an energy output port 9; the energy output device 10 transmits pulsed energy to the electrode assembly 1 through the connecting tail wire. The pulsed waveform output by the energy output device is a short pulse width and high voltage pulsed waveform, the pulse width of the pulsed waveform is 0.1 - 50 us, and the voltage is 50 - 5000 V. The ablation instrument also includes a back reference electrode 11, and the back reference electrode is connected to the energy output device. The ablation instrument also includes a display 12 for the convenience of the operator; the ablation instrument also includes an R-wave detection device 13 for R-wave gating of the pulsed energy mode.

[0102] In this embodiment, the ablation instrument applies a pulse to the electrode assembly through the energy output device to perform local ablation on the ablation target. The ablation instrument has monopolar and bipolar discharge modes. In the monopolar mode, the electrode of the electrode assembly 1 and the back reference electrode 11 form a discharge loop. In this discharge form, the formed ablation interval is large, and the myotonic phenomenon caused is also relatively obvious; in the bipolar mode, the electrodes of the electrode assembly 1 form a discharge loop. In this discharge form, the ablation interval is relatively concentrated, and the myotonic phenomenon can be significantly reduced.

[0103] Figure 11 A control method for an electrode assembly provided for an exemplary embodiment of the present invention is applied to the electrode assembly in any of the above, and the control method includes:

[0104] Step 101: Respond to the ablation mode selection and determine the ablation depth matching the ablation mode;

[0105] Step 102: Apply a pulse matching the ablation pulse to the built-in electrode and the external electrode.

[0106] Specifically, when a pulsed electric field acts on tissue, an electric field strength is generated between the positive and negative electrodes. When the magnitude of the electric field strength value reaches a certain threshold, electroporation occurs inside the tissue cells, inducing cell death, that is, an ablation zone is generated. Different ablation modes apply different ablation pulses to the internal electrode and the external electrode, which can produce different discharge methods, thereby affecting the width and depth of ablation. In actual use, different ablation modes can be selected according to the size and depth of the ablation target. The energy output device of the ablation instrument applies the ablation pulses in the matching ablation mode to the internal electrode and the external electrode, thereby achieving the purpose of ablation. Since the electrode assembly uses an internal electrode, a discharge circuit is formed between the electrodes. In this ablation mode, the ablation zone is relatively concentrated, and the muscle tremor phenomenon can be significantly reduced.

[0107] In one embodiment, the external electrode includes a first external electrode, a second external electrode, and a third external electrode. In response to the ablation depth, applying pulses to the internal electrode and the external electrode includes:

[0108] When the ablation depth is 1 mm to 5 mm, applying a positive pulse to the internal electrode and a negative pulse to the second external electrode;

[0109] When the ablation depth is 1 mm to 7 mm, applying a positive pulse to the internal electrode and negative pulses to the second external electrode and the third external electrode;

[0110] When the ablation depth is 1 mm to 10 mm, applying positive pulses to the internal electrode and the first external electrode and negative pulses to the second external electrode and the third external electrode;

[0111] The ablation depth is proportional to the pulse voltage.

[0112] Specifically, different external electrodes and internal electrodes can select different ablation modes according to different ablation targets.

[0113] When the ablation depth is 1 mm to 5 mm, the first ablation mode can be adopted, and its discharge form is as Figure 12 shown. In the figure, the hatched filled area is the range covered above the electric field strength threshold, and the square represents the boundary of the ablated tissue. Applying a positive pulse to the internal electrode and a negative pulse to the second external electrode to ablate the tissue.

[0114] When the ablation depth is 1 mm to 7 mm, the second ablation mode can be adopted, and its discharge form is as Figure 13 shown. Applying a positive pulse to the internal electrode and negative pulses to the second external electrode and the third external electrode to ablate the tissue.

[0115] When the ablation depth is 1 mm to 10 mm, the third ablation mode can be adopted, and its discharge form is as Figure 14As shown, a positive pulse is applied to the built-in electrode and the first external electrode, and a negative pulse is applied to the second external electrode and the third external electrode to ablate the tissue.

[0116] Under the same pulse parameters, for the above different ablation modes, the ablation areas and ablation depths generated at the target tissue are different, and the corresponding curves are as Figure 15 shown. In the first ablation mode, the built-in electrode and a single external electrode form a discharge circuit, and the formed ablation depth is between 1 and 5 mm.

[0117] In the second ablation mode, the built-in electrode 102 serves as the positive electrode, and at least two external electrodes such as the outer second external electrode 202 and the third external electrode 203 serve as the negative electrodes. The ratio of the electrode surface area of the negative electrode to the positive electrode, that is its K value is greater than that of the first ablation mode. Therefore, the formed ablation area and ablation depth are both greater than those of the first ablation mode, and the formed ablation depth is between 1 and 7 mm.

[0118] In the third ablation mode, the built-in electrode 102 and the outer first external electrode 201 both serve as the positive electrodes, and at least two external electrodes such as the outer second external electrode 202 and the third external electrode 203 serve as the negative electrodes. The corresponding impedance value decreases, and the formed ablation area and ablation depth are both greater than those of the second ablation mode, and the formed ablation depth is between 1 and 10 mm.

[0119] Under the same pulse parameters, for the above different ablation modes, in the ablation area generated at the target tissue, the ratio of the ablation depth to the ablation width is also different, as Figure 16 shown. In the first ablation mode and the second ablation mode, a discharge circuit is formed between the built-in electrode and the external electrode, and the formed width value is small. In the third ablation mode, the built-in electrode and the first external electrode serve as one polarity, and form a discharge circuit with the remaining external electrodes, significantly increasing the ablation width, and the ratio of its depth to width is the smallest.

[0120] In this embodiment, through a variety of different discharge methods, different discharge modes can be adapted according to the width and depth of the ablation target, and the built-in electrode is installed inside the tube body 101. While ensuring the ablation depth, the ablation width can be reduced, so that the electric field can be better concentrated at the target tissue in contact with the built-in electrode, forming an ablation area locally in the tissue and reducing the influence of ablation on non-target tissues.

[0121] In one embodiment, when the electrode assembly includes a needle electrode, the control method includes:

[0122] Applying a positive pulse to the built-in electrode and a negative pulse to the needle electrode;

[0123] The depth of the ablation area is determined according to the fitting formula;

[0124]

[0125] In the formula, Deep is the ablation depth, L is the length of the needle electrode, D is the diameter of the needle electrode, and k 1 ~k 5 are fitting coefficients.

[0126] Specifically, for the deeper ventricular part, the needle electrode is involved in ablation. The needle electrode is introduced from the proximal end of the handle and inserted into the target ablation site along the PI tube inside the built-in electrode. The electrode needle is used as the positive polarity. In the monopolar mode, the electrode needle is used as the positive polarity and the back reference electrode is used as the negative polarity; in the bipolar mode, the electrode needle and the built-in electrode or the external electrode form a discharge circuit to form an ablation lesion at the target ablation site. As Figure 17 shown, ablation lesions can be formed in the area where the ablation is inserted.

[0127] In the above needle electrode ablation control method, the size of the ablation area is determined by the length and diameter of the needle electrode. The relationship curve between the size of the ablation area at the tissue and the length of the needle electrode is as Figure 18 shown. As the length of the needle electrode increases, the ablation depth inside the tissue increases, and the ablation volume shows a trend of increasing first and then flattening. As the length of the needle electrode increases, the electrode surface area of the positive electrode gradually increases, and the electrode surface area of the negative electrode remains unchanged, resulting in a decrease in the current density of the positive electrode. Therefore, the length of the needle electrode should not be too long, and the length of the needle electrode is 1 mm to 20 mm.

[0128] In the above needle electrode ablation method, the relationship curve between the size of the ablation area at the tissue and the diameter of the needle electrode is as Figure 19 shown. As the diameter of the needle electrode increases, the ablation depth inside the tissue increases, and the ablation width also increases. If the diameter of the needle electrode is too small, the current density on the electrode surface will increase, which will increase the amount of bubbles on the electrode surface; if the diameter of the needle electrode is too thick, it will increase the wound at the tissue and increase the pain. Therefore, the diameter of the needle electrode should be appropriate. The diameter of the needle electrode is 0.1 mm to 2 mm, and the ablation depth formed by the needle electrode is between 1 mm and 20 mm.

[0129] In the above needle electrode ablation method, the depth size of the ablation area is determined by the length and diameter of the needle electrode. Draw a curve graph of the depth value of the ablation lesion corresponding to the length and diameter of the needle electrode, as Figure 20 shown. Based on the relationship curve graph, establish the relationship expression between the ablation depth and the length and diameter of the needle electrode as follows:

[0130]

[0131] Wherein, Deep is the ablation depth, L is the length of the needle electrode, D is the diameter of the needle electrode, and k 1 ~k 5 are fitting coefficients.

[0132] In this embodiment, the needle electrode can ablate tissues with a certain thickness, can provide corresponding ablation strategies for tissues with different thicknesses, and determine the relationship between the length and diameter of the needle electrode and the ablation width and depth according to the fitting formula, which is more conducive to selecting different needle electrode lengths and diameters for local ablation according to different ablation targets.

[0133] Figure 21 FIG. is a schematic structural diagram of an electronic device shown in an exemplary embodiment of the present invention. The electronic device includes a memory, a processor, and a computer program stored in the memory and configured to run on the processor. When the processor executes the computer program, it implements the control method of the electrode assembly described in any of the above embodiments. Figure 21 The electronic device 90 shown is merely an example and should not impose any limitation on the functions and usage scope of the embodiments of the present invention.

[0134] As Figure 21 shown, the electronic device 90 may be presented in the form of a general-purpose computing device, for example, it may be a server device. The components of the electronic device 90 may include, but are not limited to: the at least one processor 91 described above, the at least one memory 92 described above, and a bus 93 connecting different system components (including the memory 92 and the processor 91).

[0135] The bus 93 includes a data bus, an address bus, and a control bus.

[0136] The memory 92 may include volatile memory, such as a random access memory (RAM) 921 and / or a cache memory 922, and may further include a read-only memory (ROM) 923.

[0137] The memory 92 may further include a program tool 925 (or utility) having a set of (at least one) program modules 924. Such program modules 924 include, but are not limited to: an operating system, one or more application programs, other program modules, and program data. Each or some combination of these examples may include the implementation of a network environment.

[0138] The processor 91 executes various functional applications and data processing by running the computer program stored in the memory 92, such as the control method of the electrode assembly provided in any of the above embodiments.

[0139] The electronic device 90 can also communicate with one or more external devices 94 (such as a keyboard, a pointing device, etc.). Such communication can be carried out through the input / output (I / O) interface 95. Moreover, the electronic device 90 can also communicate with one or more networks (such as a local area network (LAN), a wide area network (WAN) and / or a public network, such as the Internet) through the network adapter 96. As shown in the figure, the network adapter 96 communicates with other modules of the electronic device 90 through the bus 93. It should be understood that although not shown in the figure, other hardware and / or software modules can be used in combination with the electronic device 90, including but not limited to: microcode, device drivers, redundant processors, external disk drive arrays, RAID (redundant array of independent disks) systems, tape drives, and data backup storage systems, etc.

[0140] It should be noted that although several units / modules or sub-units / modules of the electronic device are mentioned in the above detailed description, this division is merely exemplary and not mandatory. In fact, according to the embodiments of the present invention, the features and functions of two or more of the above-described units / modules can be embodied in one unit / module. Conversely, the features and functions of one unit / module described above can be further divided and embodied by multiple units / modules.

[0141] The embodiment of the present invention also provides a computer-readable storage medium, on which a computer program is stored, and when the program is executed by a processor, the control method of the electrode assembly provided in any of the above embodiments is implemented.

[0142] Among them, the more specific readable storage medium that can be adopted can include but not limited to: a portable disk, a hard disk, a random access memory, a read-only memory, an erasable programmable read-only memory, an optical storage device, a magnetic storage device, or any suitable combination of the above.

[0143] The embodiment of the present invention also provides a computer program product, including a computer program, and when the computer program is executed by a processor, the control method of the electrode assembly described in any of the above is implemented.

[0144] Among them, the program code for executing the computer program product of the present invention can be written in any combination of one or more programming languages, and the program code can be executed completely on the user device, partially on the user device, executed as an independent software package, partially on the user device and partially on a remote device, or completely on a remote device.

[0145] Although the specific embodiments of the present utility model have been described above, those skilled in the art should understand that this is only an example, and the protection scope of the present utility model is defined by the appended claims. Without departing from the principle and essence of the present utility model, those skilled in the art can make various changes or modifications to these embodiments, but these changes and modifications all fall within the protection scope of the present utility model.

Claims

1. An electrode assembly for local ablation, characterized in that: include: hollow tube body; A built-in electrode, wherein the entire structure of the built-in electrode is located inside the tube body; The external electrode is arranged on the outer wall surface of the tube body.

2. The electrode assembly according to claim 1, characterized in that The built-in electrode is funnel-shaped, a first opening of the built-in electrode is close to the opening of the tube body, a second opening of the built-in electrode is far from the opening of the tube body, and the first opening is larger than the second opening; And / or, the diameter of the first opening of the built-in electrode ranges from 0.5 mm to 2.8 mm; And / or, the diameter of the second opening of the built-in electrode ranges from 0.25 mm to 2.7 mm; And / or, the length of the built-in electrode is 1 mm to 6 mm; And / or, the distance between the first opening of the built-in electrode and the opening of the tube body ranges from 0.2 mm to 2 mm.

3. The electrode assembly according to claim 1, characterized in that The shape of the external electrode is ring-shaped; And / or, the outer diameter of the external electrode is in the range of 0.7 mm to 3.0 mm; And / or, the length of the external electrode ranges from 0.5 mm to 8 mm; And / or, the number of the external electrodes is at least 2, each external electrode is arranged at intervals around the axial direction of the tube body, and the external electrodes are separated by insulators, and the lengths of each external electrode are not exactly the same; And / or, the number of the external electrodes is 4, the distance between the first external electrode and the opening of the tube body ranges from 0.5mm to 2mm, the distance between the second external electrode and the first external electrode ranges from 2mm to 8mm, the distance between the third external electrode and the second external electrode ranges from 1mm to 5mm, and the distance between the fourth external electrode and the third external electrode ranges from 1mm to 5mm.

4. The electrode assembly as claimed in claim 1, characterized in that The electrode assembly also includes a needle electrode; The built-in electrode is a hollow structure, the needle electrode penetrates the built-in electrode, and the built-in electrode and the needle electrode are separated by an insulator.

5. The electrode assembly according to claim 4, characterized in that The electrode assembly also includes a first conduit and a connecting wire; One end of the needle electrode is sleeved in the first catheter, the first catheter contains the connecting wire connected to the needle electrode, and the needle electrode is connected to an external socket through the connecting wire; the connecting wire is used to drive the needle electrode to move relative to the built-in electrode under the drive of an external force; And / or, the diameter of the needle electrode is 0.1 mm-2 mm; And / or, the length of the needle electrode is 1 mm-20 mm.

6. The electrode assembly according to claim 5, characterized in that The electrode assembly further comprises a stopper assembly clamped at the second opening of the built-in electrode, the stopper assembly is a hollow structure, the needle electrode passes through the stopper assembly, and the inner diameter of the stopper assembly is larger than the outer diameter of the needle electrode and smaller than the outer diameter of the first catheter; And / or, the inner diameter of the limit assembly ranges from 0.05 mm to 1.0 mm; And / or, the wall thickness of the limiting component ranges from 0.05 mm to 0.35 mm.

7. An ablation assembly, characterized in that: The invention comprises an outer tube and an electrode assembly as claimed in any one of claims 1 to 6, wherein the electrode assembly is connected to the outer tube.

8. The ablation assembly according to claim 7, wherein: The ablation assembly also includes a second catheter, which is placed inside the tube body, one end of which is connected to the end surface of the second opening of the built-in electrode, and the other end of which serves as a saline injection port.

9. The ablation assembly according to claim 7, characterized in that: The outer tube is a multi-lumen tube, and each cavity is provided with a connecting line connected to the built-in electrode and the external electrode.

10. The ablation assembly according to claim 8, wherein: The ablation assembly also includes a handle. The outer end of the second catheter is a bendable section. The bendable section is connected to the electrode assembly. The bendable section is connected to a bending control knob on the handle via a connecting line located in the second catheter.

11. An ablation apparatus, comprising an energy output device, characterized in that: It also includes an ablation component as described in any one of claims 7-10, and the energy output device is connected to the ablation component.

12. The ablation apparatus according to claim 11, characterized in that: The ablation apparatus further comprises: An R wave detection device, which is used for R wave gating in ablation mode; And / or, further comprising a back reference electrode, wherein the back reference electrode is connected to the energy output device.

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