Ablation device and ablation system

Abstract

The invention relates to the technical field of medical instruments, and discloses an ablation device and an ablation system. The ablation device is provided with a main body tube and an ablation assembly, the ablation assembly at least comprises at least one supporting piece, at least one electrode pair and at least one insulation filling piece, the supporting piece is arranged at the far end of the main body tube, and the electrode pair and the insulation filling piece are arranged on the at least one supporting piece; the electrode pair comprises two electrodes, the two electrodes of the electrode pair comprise acting surfaces, and the acting surfaces are used for enabling ablation energy to act on target tissue; at least one electrode pair is correspondingly provided with at least one insulating filling piece; the at least one insulating filling piece is positioned between the two electrodes of the corresponding electrode pair; the ablation device comprises an expansion configuration, and under the expansion configuration, two electrodes of the electrode pair are used for pairing pulse discharge to generate a pulse electric field; in the direction perpendicular to the center line of the supporting piece, under the expansion configuration, the distance between at least part of the outer wall of the insulating filling piece and the acting face of at least one electrode of the corresponding electrode pair ranges from 0 mm to 3 mm.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to an ablation device and an ablation system. Background Art

[0002] At present, pulsed electric field ablation can theoretically damage myocardial cells without heating the tissue, and has cell / tissue selectivity, protecting key structures around the ablated tissue. It has become one of the important means to achieve pulmonary vein isolation.

[0003] However, when conventional ablation devices discharge, the high electric field is concentrated at the electrode edges, making it difficult to effectively damage the target myocardial tissue, potentially resulting in low efficiency. Furthermore, the high voltage used during ablation can easily cause arcing between the electrodes under high-voltage conditions. There are two possible causes for arcing in high-voltage pulsed electric fields. First, the close proximity of the electrodes allows the high-voltage charge to be discharged through the surface, leading to breakdown of the dielectric between the electrodes and arcing. Second, the strong electric field may cause microbubbles in the dielectric between the electrodes to break down. The breakdown threshold of microbubbles on the electrode surface is related to the electric field strength. Arcing may be closely related to the localized ultrahigh electric field strength or current density generated at the electrode edges. A higher electric field strength exerts a stronger force on the gas molecules within the bubbles, ionizing them more easily and thus lowering the bubble breakdown threshold. Excessively high current density accelerates the electrolysis of the solution, rapidly generating a large number of microbubbles on the electrode surface. These microbubbles cover the electrode, potentially forming a barrier with poor conductivity. Under the continuous application of high voltage, the microbubbles break down, triggering arcing. The generation of electric arc may not only interfere with the stability of the ablation process, but also increase the risk of thrombosis, posing a threat to the patient's health.

[0004] Based on this, there is an urgent need for an ablation device and an ablation system to solve at least one of the above problems. Summary of the Invention

[0005] In one embodiment, the present application provides an ablation device and an ablation system, which are beneficial to reducing arc discharge phenomena at the electrode edge, thereby helping to reduce the probability of vascular embolism.

[0006] In a first aspect, an ablation device is provided, comprising at least a main body tube and an ablation assembly disposed at a distal end of the main body tube, the ablation assembly comprising at least the main body tube, at least one support member, at least one electrode pair, and at least one insulating filler, the support member being disposed at the distal end of the main body tube, the electrode pair and the insulating filler being both disposed on at least one of the support members;

[0007] The electrode pair includes two electrodes, and the two electrodes of the electrode pair include active surfaces, and the active surfaces are used to apply ablation energy to the target tissue;

[0008] At least one of the electrode pairs is correspondingly provided with at least one insulating filler;

[0009] At least one insulating filler is located between the two electrodes of the corresponding electrode pair;

[0010] The ablation device includes an expanded configuration, in which the two electrodes of the electrode pair are used for paired pulse discharge to generate a pulsed electric field;

[0011] Along a direction perpendicular to the centerline of the support member, in the expanded configuration, a distance between at least a portion of an outer wall of the insulating filler and the active surface of at least one electrode of the corresponding electrode pair is 0 mm-3 mm.

[0012] As an optional technical solution for an ablation device, at least part of the outer wall of the insulating filling piece is flush with the active surface of at least one electrode of the corresponding electrode pair, or at least part of the outer wall of the insulating filling piece protrudes from the active surface of at least one electrode of the corresponding electrode pair.

[0013] As an optional technical solution for an ablation device, along a direction perpendicular to the center line of the support member, in the expanded configuration, the distance between at least part of the outer wall of the insulating filling member and the active surface of at least one electrode of the corresponding electrode pair is 0.5mm-3mm.

[0014] As an optional technical solution for an ablation device, in the expanded configuration, the insulating filling member corresponding to the electrode pair contacts at least one electrode of the corresponding electrode pair.

[0015] As an optional technical solution of an ablation device, the electrode is ellipsoidal in shape, and the extension direction of the short axis of the electrode is the same as the length direction of the support member itself.

[0016] As an optional technical solution of an ablation device, the electrode is ellipsoidal in shape, and the extension direction of the long axis of the electrode is the same as the length direction of the support member itself.

[0017] As an optional technical solution of an ablation device, in the expanded configuration, the insulating filler has at least a curved surface, and the length extension direction of the curved surface of the insulating filler is the same as the length direction of the support member itself.

[0018] As an optional technical solution for an ablation device, in the expanded configuration, the insulating filler is ellipsoidal, the extension direction of the long axis of the insulating filler is the same as the extension direction of the long axis of the electrode, and the size of the long axis of the insulating filler is 2mm-8mm.

[0019] As an optional technical solution of an ablation device, the insulating filling member is a capsule, and the capsule can be filled with a medium to expand the capsule.

[0020] As an optional technical solution of an ablation device, the balloon is a non-compliant balloon, a semi-compliant balloon, or a compliant balloon.

[0021] As an optional technical solution of an ablation device, the insulating filler is a solid insulating structure.

[0022] As an optional technical solution for an ablation device, at least one of the support members is linear, annular, or spiral; or, there are multiple support members, each of which includes at least two support bars, and the multiple support bars are enclosed in a basket shape.

[0023] As an optional technical solution for an ablation device, when the ablation device is in an expanded configuration, the maximum outer diameter of the ablation component ranges from 20 mm to 40 mm.

[0024] As an optional technical solution for an ablation device, a sheath is provided outside the main tube, and the sheath is used to accommodate at least part of the main tube and at least part of the ablation assembly. The main tube can be movably changed in position along the axial direction of the sheath.

[0025] As an optional technical solution for an ablation device, the main tube includes an inner tube and an outer tube sleeved outside the inner tube, the support member is fixed to the distal end of the outer tube, the electrode is a hollow structure, the distal end of the inner tube is located inside the hollow structure, and the inner tube is used to inject a cooling medium into the hollow structure.

[0026] In a second aspect, an ablation system is provided, comprising:

[0027] a signal generator configured to generate a pulse waveform;

[0028] an ablation device coupled to the signal generator and configured to receive the pulse waveform, the ablation device comprising at least a main body tube and an ablation assembly disposed at a distal end of the main body tube;

[0029] The ablation assembly comprises at least one support member, at least one electrode pair and at least one insulating filler, wherein the support member is provided at the distal end of the main body tube, and the electrode pair and the insulating filler are both provided on the support member;

[0030] The electrode pair includes two electrodes, and the two electrodes of the electrode pair include active surfaces, and the active surfaces are used to contact the target tissue;

[0031] At least one of the electrode pairs is correspondingly provided with at least one insulating filler;

[0032] At least one of the insulating fillers is located between the two electrodes of the corresponding electrode pair;

[0033] The ablation device includes an expanded configuration, in which the electrode pair is used for pulse discharge to generate a pulsed electric field, and at least a portion of the outer wall of the insulating filling member protrudes from the outer wall of the corresponding electrode pair.

[0034] In a third aspect, an ablation system is provided, comprising:

[0035] a signal generator configured to generate a pulse waveform;

[0036] an ablation device coupled to the signal generator and configured to receive the pulse waveform, the ablation device comprising at least a main body tube and an ablation assembly disposed at a distal end of the main body tube;

[0037] The ablation assembly comprises at least one support member, at least one electrode pair and at least one insulating filler, wherein the support member is provided at the distal end of the main body tube, and the electrode pair and the insulating filler are both provided on the support member;

[0038] The electrode pair includes two electrodes, and the two electrodes of the electrode pair include active surfaces, and the active surfaces are used to contact the target tissue;

[0039] At least one of the electrode pairs is correspondingly provided with at least one insulating filler;

[0040] At least one of the insulating fillers is located between the two electrodes of the corresponding electrode pair;

[0041] The ablation device includes an expanded configuration, in which the electrode pair is used for pulse discharge to generate a pulsed electric field, and at least a portion of the outer wall of the insulating filling member is flush with the outer wall of the corresponding electrode pair.

[0042] The present application provides an ablation device and an ablation system. In the direction perpendicular to the center line of the support member, in the expanded configuration, the distance between at least part of the outer wall of the insulating filler and the active surface of at least one electrode of the corresponding electrode pair is 0mm-3mm. During the ablation process, since the current path generated by the electrode will follow the shortest path, that is, the path with the least resistance, and after the insulating filler is placed between two adjacent electrodes, the outer wall of the insulating filler is higher than or flush with the outer wall of the electrode, it will be difficult for the electric field lines to pass directly through the insulating filler. When the electric field lines emitted from one electrode reach the insulating filler, they will quickly change direction and flow laterally along the outer contour line of the insulating filler, and then gradually extend to the other electrode paired with the electrode. The overall bending degree or flow degree of the electric field lines is increased compared to when no insulating filler is added. Since the electric field lines will deviate in the direction away from the center point of the insulating filler, the electric field line density in the space where the insulating filler is located is relatively reduced, while in the area outside the insulating filler (such as close to the outer contour line of the insulating filler), the electric field line density in the ablation area is relatively increased, which is conducive to maintaining the continuity of the electric field lines and the total flux unchanged.

[0043] In this application, the current distribution will be distorted by the contour of the insulating filler, the current density will decrease between the shortest distance between adjacent electrodes, and the electric field strength will be reduced. By reducing the electric field strength of adjacent electrodes, it is helpful to reduce the dielectric breakdown of bubbles at the edge of the electrodes, thereby helping to reduce arc discharge and reduce the probability of vascular embolism.

[0044] Furthermore, the current density at any point in the ablation area in the direction perpendicular to the center line of the support member of the present application is relatively increased, that is, the electric field strength at the ablation site is increased, and a higher voltage can be applied during the operation, which is beneficial for obtaining a higher field strength at the ablation site, improving the ablation effect, and applying as much electric field energy as possible to the target myocardial tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following is a brief introduction to the drawings required for use in the description of the embodiments of the present application. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present application and these drawings without any creative work.

[0046] Figure 1 This is one of the partial structural diagrams of the ablation assembly provided in at least one embodiment of the present application;

[0047] Figure 2 This is one of the structural diagrams of the ablation assembly provided in at least one embodiment of the present application;

[0048] Figure 3 This is the second partial structural diagram of the ablation assembly provided in at least one embodiment of the present application;

[0049] Figure 4 This is the second structural diagram of the ablation assembly provided in some other embodiments of the present application;

[0050] Figure 5 This is the third partial structural diagram of the ablation assembly provided in some other embodiments of the present application;

[0051] Figure 6 This is the fourth partial structural diagram of the ablation assembly provided in some other embodiments of the present application;

[0052] Figure 7 This is the fifth partial structural diagram of the ablation component provided in some other embodiments of the present application.

[0053] The following are marked in the figure:

[0054] 1. Main tube; 11. Inner tube; 12. Outer tube; 2. Ablation assembly; 21. Electrode pair; 211. Electrode; 22. Insulating filler; 221. Injection membrane; 23. Support member; 231. Support bar; 3. Pressure sensor; 4. Sheath. DETAILED DESCRIPTION

[0055] It should be understood that the examples and illustrations in this application are for illustrative purposes, and that deviations and variations may be constructed and deployed according to the teachings of this application without departing from the scope of this application. Before describing in detail at least one embodiment of the present application, it should be understood that this application is not necessarily limited to the details of the construction and arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. This application is capable of other embodiments or can be practiced or implemented in different ways.

[0056] Unless otherwise defined, all technical and / or scientific terms used in this application have the same meanings as those of ordinary skill in the art to which this application belongs. Although methods and materials similar to those described in this application or equivalent can be used to practice or test the embodiment of the application, exemplary methods and / or materials are described below. In the event of a conflict, the present application specification (including definitions) shall prevail. In addition, these materials, methods and embodiments are only illustrative and are not intended to be necessarily restricted.

[0057] In the description of this application, unless otherwise expressly specified or limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances. In addition, the descriptions of the terms "first", "second", etc. are only used to distinguish in the description and have no special meaning.

[0058] In the present application, the distal end refers to the end of the ablation device and at least some of its components that are exemplarily away from the operator when in use (or in other words, the distal end refers to the end of the ablation device and at least some of its components that are exemplarily in contact with / intervening with the tissue of the living body when used on the living body), and the proximal end refers to the end of the ablation device and at least some of its components that are exemplarily close to the operator when in operation (or in other words, the proximal end refers to the end of the ablation device and at least some of its components that are exemplarily farther away from the tissue of the living body than the distal end when used on the living body).

[0059] like Figure 1 and Figure 2As shown, at least one embodiment of the present application provides an ablation device, comprising at least a main body tube 1 and an ablation assembly 2 provided at the distal end of the main body tube 1, the ablation assembly 2 comprising at least at least one support member 23, at least one electrode pair 21 and at least one insulating filler 22, the support member 23 being provided at the distal end of the main body tube 1, the electrode pair 21 and the insulating filler 22 being both provided on the at least one support member 23. The electrode pair 21 comprises two electrodes 211, the two electrodes 211 of the electrode pair 21 comprising an active surface, the active surface being used to apply ablation energy to the target tissue. At least one electrode pair 21 is correspondingly provided with at least one insulating filler 22. At least one insulating filler 22 is located between the two electrodes 211 of its corresponding electrode pair 21. The ablation device comprises an expanded configuration, in which the two electrodes 211 of the electrode pair 21 are used for paired pulse discharge to generate a pulsed electric field, thereby at least forming ablation energy to act on the target tissue. Along the direction perpendicular to the center line of the support member 23, in the expanded configuration, the distance between at least part of the outer wall of the insulating filler 22 and the active surface of at least one electrode 211 of the corresponding electrode pair 21 is 0mm-3mm. During the ablation process, since the current path generated by the electrode 211 will follow the shortest path, that is, the path with the least resistance, after the insulating filler 22 is placed between two adjacent electrodes 211, the outer wall of the insulating filler 22 is higher than the outer wall of the electrode 211, which makes it difficult for the electric field lines to pass directly through the insulating filler 22. The electric field lines emitted from one electrode 211 will not pass through the insulating filler 22 when reaching the insulating filler 211. 2, it will quickly change direction, bend to the side along the outer contour line of the insulating filler 22, and then gradually extend to the other electrode 211 paired with the electrode 211. The overall bending degree of the electric field line is increased compared to when the insulating filler 22 is not added. Since the electric field line will shift in the direction away from the center point of the insulating filler 22, the electric field line density in the space where the insulating filler 22 is located is relatively reduced, and in the area outside the insulating filler 22 (such as near the outer contour line of the insulating filler 22), the electric field line density in the ablation area is relatively increased, which is conducive to maintaining the continuity of the electric field line and the total flux unchanged.

[0060] In some embodiments, the current distribution is distorted by the contour of the insulating filler 22, causing the current density to decrease at the shortest distance between adjacent electrodes 211, thereby reducing the electric field strength. Reducing the electric field strength between adjacent electrodes 211 helps reduce dielectric breakdown of bubbles at the edges of the electrodes 211, thereby reducing arc discharge and, in turn, the probability of vascular embolism. Furthermore, the current density at any point in the ablation region perpendicular to the centerline of the support member 23 increases, meaning that the electric field strength at the ablation site increases. Furthermore, a higher voltage can be applied during the procedure, thereby achieving a higher field strength at the ablation site, improving the ablation effect, and maximizing the application of electric field energy to the target myocardial tissue.

[0061] In some embodiments, the closer the area is to the electrode 211, the stronger the electric field strength is, and at least part of the outer wall of the insulating filler 22 is flush with the active surface of at least one electrode 211 of its corresponding electrode pair 21, wherein the portion where the outer wall of the insulating filler 22 is flush with the active surface of the electrode is beneficial to reducing the field strength loss, so that the field strength acts on the target tissue as efficiently as possible.

[0062] In some embodiments, at least a portion of the outer wall of the insulating filler 22 protrudes from the active surface of at least one electrode 211 of the corresponding electrode pair 21, so that the area where the electrode 211 is located forms a low-position portion, and the area where the insulating filler 22 is located forms a high-position portion, which is beneficial to reducing the arc discharge phenomenon at the edge of the electrode 211 and reducing the probability of vascular embolism; at the same time, it is beneficial to improve the effectiveness of the ablation device.

[0063] In other embodiments, in a direction perpendicular to the center line of the support member 23, in the expanded configuration, the distance between at least a portion of the outer wall of the insulating filler 22 and the active surface of at least one electrode 211 of the corresponding electrode pair 21 is 0.5 mm to 3 mm. If the outer wall of the insulating filler 22 protrudes too high relative to the active surface of the electrode 211, the electric field lines around the electrode 211 may be dispersed (or the electric field strength around the electrode 211 may be reduced), affecting the ablation intensity, depth or area. If the outer wall of the insulating filler 22 does not protrude enough relative to the active surface of the electrode 211, the electric field lines at the end of the electrode 211 (the end away from the insulating filler 22) may be too concentrated, increasing the risk of arcing. Optionally, the distance between at least a portion of the outer wall of the insulating filler 22 and the active surface of at least one electrode 211 of the corresponding electrode pair 21 can be any value such as 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm or 3 mm.

[0064] In some possible related technologies, adjacent electrodes 211 are spaced apart, and there are gaps between adjacent electrodes 211 of the ablation device. Therefore, a step height difference will be generated on the outer wall of the ablation device. During the sheathing process after the ablation device completes the ablation of the tissue, due to the step height difference on the outer wall of the ablation device, uneven force transmission may occur, and the force may not be able to form directional consistency / continuity, which may cause jamming between the electrodes 211 and the risk of friction damage to the blood vessels.

[0065] In some embodiments, in the expanded configuration, the insulating filler 22 corresponding to the electrode pair 21 contacts at least one electrode 211 of the corresponding electrode pair 21. Exemplarily, the insulating filler 22 corresponding to the electrode pair 21 contacts both electrodes 211 of the corresponding electrode pair 21. Providing the insulating filler 22 helps reduce or even eliminate the gap between the two electrodes 211, ensuring directional consistency / continuity of force applied to the ablation device during sheath insertion, alleviating the jamming phenomenon and allowing for smooth sheath insertion of the ablation device, thereby reducing the risk of frictional damage to the blood vessels.

[0066] Optionally, the electrode 211 is spherical or ellipsoidal, which is beneficial to improve the adhesion to the lesion location. Figure 1 As shown, when the electrode 211 is ellipsoidal, the extension direction of the long axis of the ellipsoid is the same as the extension direction of the support member 23; or as shown in FIG. Figure 3 As shown, the extending direction of the minor axis of the ellipsoid is the same as the extending direction of the support member 23. The spherical or ellipsoidal electrode 211 is beneficial for improving the contact with the lesion position, thereby improving the ablation effect.

[0067] Optionally, the insulating filler 22 is a capsule, and the insulating filler 22 can be filled with a medium to expand the capsule. When the ablation device performs ablation, the medium can fill the insulating filler 22 to expand the insulating filler 22. Among them, the insulating filler 22 can be a non-compliant balloon, a semi-compliant balloon or a compliant balloon. Exemplarily, the insulating filler 22 is a non-compliant balloon. When the ablation device is in the ablation state, the insulating filler 22 is filled with a medium and expanded, which is beneficial to filling the gap between the two adjacent electrodes 211, reducing the occurrence of sheath jamming after ablation, and is beneficial to improving the smoothness of sheathing.

[0068] In some embodiments, the electrical conductivity of the insulating filler 22 is generally less than 10 -8 s / m, the material of the semi-compliant balloon or the non-compliant balloon may be selected from but not limited to polyethylene, polyurethane, nylon or polyethylene terephthalate and other materials.

[0069] When the electrodes 211 on both sides of the insulating filler 22 (i.e., the two electrodes 211 of the electrode pair 21 corresponding to the insulating filler 22) are energized, the current between the two electrodes 211 is deflected on the contour of the insulating filler 22, which is beneficial to changing the distribution of the electric field lines between the two electrodes 211, reducing the arc discharge phenomenon at the edge position of the electrode 211, and improving the electric field strength near the middle position between the two paired electrodes 211, so as to effectively apply the electric field energy to the target myocardial tissue.

[0070] In some embodiments, in the expanded configuration, the insulating filler 22 is ellipsoidal in shape, with the long axis of the insulating filler 22 extending in the same direction as the long axis of the electrode 211. This allows for a higher electric field strength to be applied compared to a configuration without the insulating filler 22, facilitating a larger ablation area or depth. The long axis of the insulating filler 22 is 2 mm to 8 mm. If the insulating filler 22 is too short, there may be a risk of arcing. If the insulating filler 22 is too long, it may disperse the electric field lines around the electrode 211 (or reduce the electric field strength around the electrode 211), affecting the ablation intensity, depth, or area.

[0071] Optionally, in the expanded configuration, the outer diameter of the insulating filler 22 ranges from 20 mm to 40 mm. Exemplarily, in the expanded configuration, the outer diameter of the insulating filler 22 can be any value such as 20 mm, 24 mm, 26 mm, 28 mm, 30 mm, 32 mm, 34 mm or 40 mm. The outer diameter of the electrode 211 extending radially along the support member 23 ranges from 4.0 mm ± 1 mm. Exemplarily, the outer diameter of the electrode 211 extending radially along the support member 23 can range from 3 mm, 3.5 mm, 4 mm, 4.5 mm or 5 mm. The length of the electrode 211 along the extension direction of the support member 23 ranges from 6 mm ± 2 mm. Exemplarily, the length of the electrode 211 along the extension direction of the support member 23 ranges from 4 mm, 5 mm, 6 mm, 7 mm or 8 mm.

[0072] Alternatively, as Figure 2 and Figure 3 As shown, at least one support member 23 is linear, annular or spiral; or, there are multiple support members 23, and the multiple support members 23 are enclosed in a basket shape.

[0073] In some embodiments, the support member 23 is annular, and the annular support member 23 can help position at the ostium of the pulmonary vein to facilitate ablation.

[0074] In some exemplary application scenarios, such as in the treatment of atrial fibrillation, the annular design of the ablation component 2 is conducive to fitting the anatomical structure of the heart tissue, achieving pulmonary vein isolation, and facilitating uniform transmission of ablation energy to the target tissue. During the treatment process, a larger range of tissue can be ablated in a single discharge process, thereby improving ablation efficiency and success rate.

[0075] In related art, due to the gaps between the electrodes 211 on the ring, uneven force transmission during sheathing after ablation can easily cause jamming between the electrodes 211, leading to the risk of friction and damage to blood vessels. In some embodiments, an insulating filler 22 (such as a capsule) is provided between adjacent electrodes 211. When filled, the insulating filler 22 provides better support and reduces the risk of friction on blood vessels.

[0076] In some embodiments, the two electrodes 211 in the electrode pair 21 can form a positive electrode-negative electrode pair. For example, the distal electrode 211 can be configured as the positive electrode, while the proximal electrode 211 can be configured as the negative electrode. The support member 23 can be configured with 4, 5, 6, or more electrode pairs 21. Each electrode 211 is welded to an insulated electrical wire. An insulating filler 22 is provided between each pair of electrodes 211 to help reduce arc discharge effects. When the distance between the two electrodes 211 of the electrode pair 21 is the same, it is beneficial to apply a higher electric field and achieve a better ablation effect.

[0077] In some embodiments, the insulating filler 22 is fixed to the support member 23, with the distal end of the support member 23 in a blocked state. The support member 23 is provided with a plurality of through-holes, which form irrigation channels for supplying liquid to the insulating filler 22 (e.g., a bladder). The diameter of the through-holes communicating with the insulating filler 22 gradually increases from the proximal end to the distal end, thereby facilitating the supply of sufficient liquid to fill the insulating filler 22 at the distal end of the support member 23. When the insulating filler 22 is filled, its surface assumes an arc shape. When the electrodes 211 are energized, the electric field distribution between adjacent electrodes 211 changes due to the arc shape of the surface of the insulating filler 22, thereby improving ablation efficiency and reducing arc discharge at the edges of the electrodes 211.

[0078] In some embodiments, the ablation device includes at least one wire electrically connected to the electrode 211 for supplying power to the electrode 211. When the ablation device is used for bipolar ablation, the polarities of the two electrodes 211 of the electrode pair 21 are opposite. In other words, any two electrodes 211 with opposite polarities form an electrode pair 21 to output ablation energy. When used for electrophysiological mapping, any electrode 211 can be used alone to collect electrophysiological signals to achieve electrophysiological mapping. When the ablation device is used for unipolar ablation, all electrodes 211 at the distal end of the main tube 1 have the same polarity, and at least one electrode 211 with opposite polarity is provided on the main tube 1 or on the sheath, for example, it can be located in the inferior vena cava or outside the body.

[0079] In some embodiments, N electrode pairs 21 are spaced apart along the length direction of the support member 23 , where N is a positive integer, and at least one insulating filler 22 is disposed between adjacent electrodes 211 .

[0080] In some embodiments, the ablation device further includes a handle assembly, which is disposed on the main tube 1 (such as the proximal end of the main tube 1 ), and the shape or configuration (such as the expansion configuration) of the ablation component 2 is controlled by the handle assembly, which is prior art.

[0081] like Figure 4 and Figure 5As shown, in some other embodiments, a sheath 4 is provided outside the main tube 1. The sheath 4 is used to accommodate at least a portion of the main tube 1 and at least a portion of the ablation assembly 2. The main tube 1 can be movably changed in position along the axial direction of the sheath 4. The ablation assembly 2 has one electrode pair 21, and the two electrodes 211 of the electrode pair 21 are respectively fixed to the support member 23 and the sheath 4. For example, the two electrodes 211 of the electrode pair 21 are respectively fixed to the distal end of the support member 23 and the distal end of the sheath 4.

[0082] In some embodiments, the distal end of the sheath 4 is bendable to facilitate adjustment of the position of the electrode pair 21 .

[0083] In some embodiments, the main tube 1 includes an inner tube 11 and an outer tube 12 sleeved outside the inner tube 11. The support member 23 is fixed to the distal end of the outer tube 12. For example, the proximal end of the support member 23 and the distal end of the outer tube 12 are thermally melted into one piece by a polymer material, or the support member 23 and the outer tube 12 are an integrally molded structure. The two electrodes 211 of the electrode pair 21 are respectively fixed to the distal end of the support member 23 and the distal end of the sheath tube 4. The electrode 211 fixed on the support member 23 is a hollow structure. The proximal end of the inner tube 11 is fixed to the handle assembly, and the distal end of the inner tube 11 is located in the hollow structure. The distal end of the inner tube 11 extends into the internal space of the electrode 211 on the support member 23. The inner tube 11 is used to inject a cooling medium to cool the electrode 211 on the support member 23.

[0084] In some other embodiments, the two electrodes 211 of the electrode pair 21 are fixed to the distal end of the support member 23 and the distal end of the outer tube 12, respectively.

[0085] In some embodiments, the support member 23 is bendable to facilitate adjustment of the position of the electrode 211 on the support member 23 .

[0086] Optionally, at least part of the surface of the electrode 211 near the distal end is hemispherical (for example, the distal surface of the electrode 211), which increases the contact area between the electrode 211 and the lesion while also helping to reduce or avoid arc discharge caused by sharp edges on the surface of the electrode 211.

[0087] In some other embodiments, a micropore with a diameter of 0.05 mm to 0.1 mm is provided on the electrode 211 near the distal end. The micropore is connected to the water irrigation channel, which is conducive to the formation of a water film on the surface of the electrode 211 during saline irrigation, helping to reduce the temperature of the electrode 211 while better avoiding the formation of blood clots and thrombi.

[0088] The two ends of the insulating filler 22 disposed between the two electrodes 211 in the longitudinal direction are respectively disposed at the distal end of the support member 23 and the distal end of the outer tube 12. The insulating filler 22 is a capsule, and the insulating filler 22 is sleeved outside the support member 23.

[0089] In some embodiments, an injection membrane 221 is provided on the outer sleeve of the outer tube 12, the distal end of the injection membrane 221 is fixed to the proximal end of the insulating filler 22, the proximal end of the injection membrane 221 is fixed to the handle assembly, the insulating filler 22 and the injection membrane 221 have an inner interface, the outer tube 12 has an outer interface, and there is a gap between the inner interface and the outer interface of the outer tube 12 to form a water injection channel.

[0090] After physiological saline is introduced into the handle assembly, the insulating filler 22 is filled through the water channel. After the insulating filler 22 is filled, the surface is arc-shaped. After power is turned on, the electric field between the two electrodes 211 changes, and the electric field strength near the middle position between the two electrodes 211 increases, which is beneficial to improving the ablation efficiency and at the same time helping to reduce the arc discharge phenomenon at the edge position of the electrode 211.

[0091] In some embodiments, the ablation device further includes a pressure sensor 3, which is disposed on the outer wall of the inner tube 11 to prevent the influence of saline on the pressure sensor 3. At least a portion of the structure of the pressure sensor 3 is located within the interior space of the electrode 211 on the support member 23, which facilitates stable and accurate transmission of force applied to the distal electrode 211 to the pressure sensor 3.

[0092] In other embodiments, Figure 6 As shown, there are multiple support members 23, each support member 23 includes at least two support bars 231, and the multiple support bars 231 are enclosed in a basket shape. Exemplarily, two pairs of electrodes 21 are provided on one support member 23, and the two electrodes 211 on each pair of electrodes 21 are respectively fixed on the two support bars 231 of the corresponding support member 23. In other words, the polarity of the electrodes 211 on the same support bar 231 is the same. The insulating filler 22 is respectively provided on the two support bars 231 of the corresponding support member 23 along both sides of the circumference of the ablation component 2. In some other possible embodiments, at least two electrodes 211 on the same support bar 231 can also form an electrode pair 21. In other words, the polarity of the electrodes 211 on the same support bar 231 is different.

[0093] In the expanded configuration, the insulating filler 22 has at least a curved surface, and the length extension direction of the curved surface of the insulating filler 22 is the same as the length direction of the support member 23 (or the support strip 231) itself. Compared with the case without a balloon, it is beneficial to apply a higher electric field strength and to achieve a larger ablation area.

[0094] In some embodiments, the plurality of insulating fillers 22 are an integrally formed structure, such as a capsule. For example, the sidewall of the filled capsule forms 2N grooves (i.e., the positions of the support bars 231), where N is a positive integer, and the 2N grooves are arranged at intervals along the circumference of the support member 23, the grooves forming a low-position portion, and the electrodes 211 are arranged in the grooves. The plurality of electrodes 211 arranged in the grooves form a basket-like structure, which is conducive to making the ablation component 2 better fit the pulmonary vein orifice and achieve isolation of the pulmonary vein. This design can produce a more uniform electric field distribution through simultaneous discharge of multiple electrodes 211, thereby improving the effect and success rate of ablation, thereby treating atrial fibrillation.

[0095] Optionally, the capsule takes a pumpkin shape after being filled, the capsule is fixed on the support 23, the electrode 211 is arranged in the groove of the capsule, and two electrodes 211 adjacent to each other along the circumference of the support 23 can form a positive-negative pair. The capsule takes a pumpkin shape after being filled, and each pair of adjacent electrodes 211 is filled with an insulating capsule, so that the electric field strength at the place where the bow of the electrode 211 is close to the ablation position is increased, which is beneficial to improving the ablation efficiency and reducing the arc discharge phenomenon at the edge of the electrode 211.

[0096] In some embodiments, as Figure 6 As shown, the electrode 211 is a wire. Alternatively, as Figure 7 As shown, the electrode 211 may also be a sheet.

[0097] In some embodiments, the insulating filler 22 is a solid insulating structure. The solid insulating structure between adjacent electrodes 211 provides better support and reduces the risk of friction with blood vessels. The function of the solid insulating structure is the same as that of the capsule described above and will not be further described in this application.

[0098] At least one embodiment of the present application provides an ablation system, comprising a signal generator and an ablation device. The signal generator is configured to generate a pulse waveform. The ablation device is coupled to the signal generator and configured to receive the pulse waveform. The ablation device comprises at least a main body tube 1 and an ablation assembly 2 disposed at the distal end of the main body tube 1. The ablation assembly 2 comprises at least one support member 23, at least one electrode pair 21, and at least one insulating filler 22. The support member 23 is disposed at the distal end of the main body tube 1, and the electrode pair 21 and the insulating filler 22 are both disposed on the support member 23. The electrode pair 21 comprises two electrodes 211, each of which comprises an active surface for applying ablation energy to the target tissue. At least one insulating filler 22 is provided corresponding to at least one electrode pair 21. The at least one insulating filler 22 is located between the two electrodes 211 of its corresponding electrode pair 21. The ablation device comprises an expanded configuration. In the expanded configuration, the electrode pair 21 is configured to generate a pulsed electric field by pulse discharge, thereby at least applying ablation energy to the target tissue. At least part of the outer wall of the insulating filler 22 protrudes from the outer wall of the corresponding electrode pair 21, so that the area where the electrode 211 is located forms a low-position part, and the area where the insulating filler 22 is located forms a high-position part, which is beneficial to reduce the arc discharge phenomenon at the edge of the electrode 211 and reduce the probability of vascular embolism.

[0099] At least one embodiment of the present application provides an ablation system, which includes a signal generator and an ablation device. The signal generator is configured to generate a pulse waveform. The ablation device is coupled to the signal generator and is configured to receive the pulse waveform. The ablation device includes at least a main tube 1 and an ablation assembly 2 provided at the distal end of the main tube 1. The ablation assembly 2 includes at least one support member 23, at least one electrode pair 21 and at least one insulating filler 22. The support member 23 is provided at the distal end of the main tube 1, and the electrode pair 21 and the insulating filler 22 are both provided on the support member 23. The electrode pair 21 includes two electrodes 211, and the two electrodes 211 of the electrode pair 21 include an active surface, which is used to apply ablation energy to the target tissue. At least one electrode pair 21 is provided with at least one insulating filler 22; at least one insulating filler 22 is located between the two electrodes 211 of its corresponding electrode pair 21; the ablation device includes an expanded configuration. In the expanded configuration, the electrode pair 21 is used for pulse discharge to generate a pulsed electric field, and at least a portion of the outer wall of the insulating filler 22 is flush with the outer wall of its corresponding electrode pair 21. The portion where the outer wall of the insulating filler 22 is flush with the active surface of the electrode helps reduce field strength loss, allowing the field strength to act on the target tissue as efficiently as possible. Furthermore, the flush portion facilitates sheathing and improves the adhesion of the electrode 211 to tissue surfaces with poor flatness.

[0100] Whenever a numerical range is indicated in this application, it is meant to include any recited value (fractional and whole) within the indicated range. The phrases "the range between a first indicated value and a second indicated value" and "the range from a first indicated value to a second indicated value" are used interchangeably herein and are meant to include the first and second indicated values and all fractional and whole values therebetween.

[0101] As used herein, when used in conjunction with numerical values and / or ranges, the terms "about" and / or "approximately" generally refer to numerical values and / or ranges that are close to the stated numerical values and / or ranges. In some cases, the terms "about" and "approximately" can mean within ±10% of the stated value. For example, in some cases, "about 100 [units]" can mean within ±10% of 100 (e.g., 90 to 110). The terms "about" and "approximately" can be used interchangeably.

[0102] As used herein, the singular forms "a", "an", and "the" include plural forms unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0103] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or components, but only if such additional ingredients, steps and / or components do not significantly alter the basic and novel characteristics of the claimed composition, method or structure.

[0104] The implementation of the method and / or system of the embodiment of the present application may include performing or completely performing the selected task manually, automatically, or a combination thereof. In addition, according to the actual instruments and equipment of the embodiment of the method and / or system of the present application, using an operating system, several selected tasks may be implemented by hardware, by software, by firmware, or by a combination thereof.

[0105] For example, the hardware for performing the selected tasks according to the embodiments of the present application can be implemented in the form of a chip or circuit. As software, the tasks selected according to the embodiments of the present application can be implemented in the form of multiple software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present application, one or more tasks according to the exemplary embodiments of the method and / or system described in the present application are performed by a data processor, such as a computing platform for executing multiple instructions. Optionally, the data processor includes a volatile memory for storing instructions and / or data and / or a non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or a removable medium. Optionally, a network connection is also provided. A display and / or user input device such as a keyboard or mouse are also optionally provided.

[0106] It should be understood that certain features of the present application that are described in the context of separate embodiments for the purpose of clarity may also be provided in combination in a single embodiment. Conversely, various features of the present application that are described in the context of a single embodiment for the purpose of brevity may also be provided individually or in any suitable subcombination or, where appropriate, in any other described embodiment of the present application. Certain features described in the context of multiple embodiments should not be considered essential features of those embodiments unless the embodiment is inoperative without those elements.

[0107] Although the present invention has been described in conjunction with its specific embodiments, it is apparent that many alternatives, modifications and variations may be apparent to those skilled in the art. It is therefore intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Claims

1. An ablation device, characterized in that: The device comprises at least a main body tube and an ablation assembly disposed at the distal end of the main body tube, wherein the ablation assembly comprises at least one support member, at least one electrode pair, and at least one insulating filler member, wherein the support member is disposed at the distal end of the main body tube, and the electrode pair and the insulating filler member are both disposed on at least one of the support members; The electrode pair includes two electrodes, and the two electrodes of the electrode pair include active surfaces, and the active surfaces are used to apply ablation energy to the target tissue; At least one of the electrode pairs is correspondingly provided with at least one insulating filler; At least one insulating filler is located between the two electrodes of the corresponding electrode pair; The ablation device includes an expanded configuration, in which the two electrodes of the electrode pair are used for paired pulse discharge to generate a pulsed electric field; Along a direction perpendicular to the centerline of the support member, in the expanded configuration, a distance between at least a portion of an outer wall of the insulating filler and the active surface of at least one electrode of the corresponding electrode pair is 0 mm-3 mm.

2. The ablation device according to claim 1, wherein: At least part of the outer wall of the insulating filling piece is flush with the active surface of at least one electrode of the corresponding electrode pair, or at least part of the outer wall of the insulating filling piece at least protrudes from the active surface of at least one electrode of the corresponding electrode pair.

3. The ablation device according to claim 1, wherein: Along a direction perpendicular to the centerline of the support member, in the expanded configuration, a distance between at least a portion of the outer wall of the insulating filler and the active surface of at least one electrode of the corresponding electrode pair is 0.5 mm to 3 mm.

4. The ablation device according to claim 1, wherein: In the expanded configuration, the insulating filler corresponding to the electrode pair contacts at least one electrode of the corresponding electrode pair.

5. The ablation device according to claim 4, characterized in that The electrode is ellipsoidal in shape, and the extension direction of the short axis of the electrode is the same as the length direction of the support member itself.

6. The ablation device according to claim 4, characterized in that The electrode is ellipsoidal in shape, and the extension direction of the long axis of the electrode is the same as the length direction of the support member itself.

7. The ablation device according to any one of claims 1 to 6, characterized in that: In the expanded configuration, the insulating filler has at least a curved surface, and the length extension direction of the curved surface of the insulating filler is the same as the length direction of the supporting member itself.

8. The ablation device according to claim 6, characterized in that In the expanded configuration, the insulating filler is ellipsoidal in shape, the extension direction of the long axis of the insulating filler is the same as the extension direction of the long axis of the electrode, and the size of the long axis of the insulating filler is 2 mm-8 mm.

9. The ablation device according to claim 1, wherein: The insulating filling member is a balloon, and the balloon can be filled with a medium to expand the balloon.

10. The ablation device according to claim 9, characterized in that: The balloon is a non-compliant balloon, a semi-compliant balloon or a compliant balloon.

11. The ablation device according to claim 1, wherein: The insulating filler is a solid insulating structure.

12. The ablation device according to any one of claims 1 to 6, characterized in that: At least one of the support members is linear, annular or spiral; or, there are multiple support members, each of which includes at least two support bars, and the multiple support bars are enclosed in a basket shape.

13. The ablation device according to any one of claims 1 to 6, characterized in that: When the ablation device is in the expanded configuration, the maximum outer diameter of the ablation component ranges from 20 mm to 40 mm.

14. The ablation device according to any one of claims 1 to 6, characterized in that: A sheath is provided outside the main tube, and the sheath is used to accommodate at least a portion of the main tube and at least a portion of the ablation assembly. The main tube can be movably changed in position along the axial direction of the sheath.

15. The ablation device according to any one of claims 1 to 6, characterized in that: The main tube includes an inner tube and an outer tube sleeved outside the inner tube, the support member is fixed to the distal end of the outer tube, the electrode is a hollow structure, the distal end of the inner tube is located inside the hollow structure, and the inner tube is used to inject cooling medium into the hollow structure.

16. An ablation system, characterized in that: It includes: a signal generator configured to generate a pulse waveform; an ablation device coupled to the signal generator and configured to receive the pulse waveform, the ablation device comprising at least a main body tube and an ablation assembly disposed at a distal end of the main body tube; The ablation assembly comprises at least one support member, at least one electrode pair and at least one insulating filler, wherein the support member is provided at the distal end of the main body tube, and the electrode pair and the insulating filler are both provided on the support member; The electrode pair includes two electrodes, and the two electrodes of the electrode pair include active surfaces, and the active surfaces are used to contact the target tissue; At least one of the electrode pairs is correspondingly provided with at least one insulating filler; At least one of the insulating fillers is located between the two electrodes of the corresponding electrode pair; The ablation device includes an expanded configuration, in which the electrode pair is used for pulse discharge to generate a pulsed electric field, and at least a portion of the outer wall of the insulating filling member protrudes from the outer wall of the corresponding electrode pair.

17. An ablation system, characterized in that: It includes: a signal generator configured to generate a pulse waveform; an ablation device coupled to the signal generator and configured to receive the pulse waveform, the ablation device comprising at least a main body tube and an ablation assembly disposed at a distal end of the main body tube; The ablation assembly comprises at least one support member, at least one electrode pair and at least one insulating filler, wherein the support member is provided at the distal end of the main body tube, and the electrode pair and the insulating filler are both provided on the support member; The electrode pair includes two electrodes, and the two electrodes of the electrode pair include active surfaces, and the active surfaces are used to contact the target tissue; At least one of the electrode pairs is correspondingly provided with at least one insulating filler; At least one of the insulating fillers is located between the two electrodes of the corresponding electrode pair; The ablation device includes an expanded configuration, in which the electrode pair is used for pulse discharge to generate a pulsed electric field, and at least a portion of the outer wall of the insulating filling member is flush with the outer wall of the corresponding electrode pair.

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