Ablation device and ablation system

Abstract

The invention belongs to the technical field of medical instruments, and discloses an ablation device and an ablation system.The ablation device comprises a catheter body, a functional component and an anchoring piece, the catheter body is provided with a center line, the functional component comprises a plurality of flexible strips, and the near ends of the flexible strips are connected with the far end of the catheter body; a discharge structure is arranged on at least part of the outer side surface, away from the center line, of at least part of flexible strips; the anchoring piece is rotationally connected with the far end of the flexible strip, and the anchoring piece can be of an insulating structure; when the functional part is in the first form, at least part of the flexible strip can move by a first distance in the radial direction of the catheter body in the direction away from the center line. When the functional component is in the second form, at least part of the flexible strip can move by a second distance in the radial direction of the catheter body in the direction away from the center line, and the first distance is larger than the second distance. According to the ablation device, through the arrangement of the anchoring piece, the adjusting force needed by deformation of the flexible strip is smaller, and the operation is safer.

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] Atrial fibrillation is one of the most common arrhythmias in clinical practice. It is characterized by the loss of orderly electrical activity in the atria under the control of sinus rhythm, which is replaced by rapid and disordered fibrillation waves. As a result, the atria lose effective contraction and relaxation, the pumping function deteriorates or is lost, and the ventricles respond extremely irregularly. It is one of the main causes of sudden cardiac death.

[0003] Electrophysiology centers have developed rapidly in recent years, with catheter ablation technology being used to treat frequent, severe paroxysmal atrial fibrillation, as well as persistent atrial fibrillation associated with a high risk of stroke. Pulsed field ablation (PFA), an emerging catheter ablation therapy, utilizes an ablation device. Pulsed electric fields selectively ablate myocardial cells while sparing blood vessels, nerves, and surrounding cardiac tissue. Furthermore, pulsed electric fields can irreversibly electroporate myocardial tissue, requiring little or no heat energy, making the ablation process efficient and rapid, shortening the ablation time.

[0004] In related art, an ablation device is housed within a sheath. The ablation device typically includes a catheter and multiple flexible strips disposed at the distal end of the catheter. Electrodes are mounted on the flexible strips, and the proximal ends of the flexible strips are typically secured to the distal end of the catheter. The distal ends of the multiple flexible strips are fixedly connected. During surgery, at least a portion of the ablation device is exposed from within the sheath. If the flexible strips need to be deformed to position the electrodes appropriately against the surface of the myocardial wall, the required adjustment force for deformation is significant, potentially requiring high levels of operator control and potentially impacting surgical safety. Summary of the Invention

[0005] In some embodiments, the present application provides an ablation device, comprising:

[0006] a catheter body having a centerline;

[0007] a functional component, the functional component being disposed at the distal end of the catheter body;

[0008] The functional component includes a plurality of flexible strips, the proximal ends of the flexible strips are connected to the distal end of the catheter body, and at least a portion of the outer surface of at least a portion of the flexible strips away from the center line is provided with a discharge structure;

[0009] The functional component includes at least a first state and a second state, and the functional component is configured so that at least the distal end of the flexible strip can move along the axial direction of the catheter body to convert between the first state and the second state;

[0010] Wherein, in the first configuration, at least a portion of the flexible strip is capable of moving a first distance in a radial direction of the catheter body away from the centerline;

[0011] In the second configuration, at least a portion of the flexible strip is movable a second distance in a radial direction of the catheter body away from the centerline, the first distance being greater than the second distance;

[0012] an anchor member located at a distal end of the functional component, the anchor member being rotatably connected to the distal end of the flexible strip, the rotation axis of the distal end of the flexible strip being at an angle to the centerline;

[0013] At least a portion of the anchoring member is an insulating structure.

[0014] Optionally, the rotation axis of the distal end of the flexible strip is perpendicular to the center line.

[0015] Optionally, at least the thickness of the distal end of the flexible strip is greater than the thickness of the proximal end of the flexible strip.

[0016] Optionally, the flexible strip comprises at least a first segment and a second segment, the proximal end of the first segment is connected to the distal end of the second segment, the distal end of the first segment is rotatably connected to the anchor, and the proximal end of the second segment is connected to the distal end of the catheter body;

[0017] In the first form, the first segment is configured to be an arc-shaped structure convex from a side close to the center line of the catheter body to a side away from the center line of the catheter body;

[0018] The bending direction of at least part of the second segment is opposite to the bending direction of the first segment.

[0019] Optionally, the anchor is provided with a plurality of clearance grooves at intervals along the circumference of the functional component, and the clearance groove is in the form of at least one side wall of the anchor away from the center line;

[0020] The number of the flexible strips is arranged in a one-to-one correspondence with the number of the clearance grooves, and the distal ends of the flexible strips are movably hinged in the corresponding clearance grooves.

[0021] Optionally, the clearance groove at least passes through the proximal surface of the anchoring member.

[0022] Optionally, the clearance groove at least passes through the distal end surface of the anchoring member.

[0023] Optionally, along the circumference of the functional component, a support block is provided between two adjacent clearance grooves, and both side walls of the support block are provided with first hinge holes, and the first hinge holes are communicated with the adjacent clearance grooves, so that any clearance groove is correspondingly provided with two first hinge holes;

[0024] The ablation device also includes a rotating shaft, which includes multiple shaft segments. At least one shaft segment is corresponding to one of the giveway grooves, and the two ends of at least one of the shaft segments in its own length direction are respectively arranged in the two first hinge holes connected to the corresponding giveway grooves. The distal end of the flexible strip is arranged in the shaft segment in the corresponding giveway groove, and the length direction of the shaft segment is the rotation axis of the flexible strip.

[0025] Optionally, the multiple shaft segments of the rotating shaft are integrally formed into a rod-shaped object, and the rotating shaft passes through the first hinge hole on each of the support blocks along the circumference of the functional component.

[0026] Optionally, the support block is provided with a mounting groove, and the mounting groove is communicated with the two first hinge holes on the support block where the mounting groove is located;

[0027] Both ends of the shaft segment in its own length direction are arranged in the mounting grooves on the corresponding support blocks.

[0028] Optionally, along the circumference of the functional component, a support block is provided between two adjacent clearance grooves, and both side walls of the support block are provided with first hinge holes, and the first hinge holes are communicated with the adjacent clearance grooves, so that any clearance groove is correspondingly provided with two first hinge holes;

[0029] A convex shaft is provided at the distal end of the flexible strip, and both ends of the convex shaft in its own length direction are respectively arranged in the two first hinge holes connected to the corresponding give way grooves, and the length direction of the convex shaft is the rotation axis of the flexible strip.

[0030] Optionally, the convex shaft is integrally formed and arranged at the distal end of the flexible strip; or the convex shaft includes a first sub-shaft and a second sub-shaft, the first sub-shaft and the second sub-shaft are respectively arranged on both sides of the flexible strip along the circumference of the functional component, and the first sub-shaft and the second sub-shaft are respectively arranged in the two first hinge holes connected to the corresponding give way grooves at one end away from the flexible strip along the circumference of the functional component.

[0031] Optionally, the outer diameter of the anchor is less than or equal to the outer diameter of the catheter body.

[0032] Optionally, the discharge structure is configured as a metal coating containing at least gold; or, the discharge structure is configured as a flexible circuit, and a discharge electrode is provided on the flexible circuit.

[0033] Optionally, at least the flexible strip is provided with insulating regions on both sides of the discharge structure, and the length of the insulating region close to the distal end of the flexible strip is shorter than the length of the insulating region close to the proximal end of the flexible strip.

[0034] Optionally, the ablation device further comprises a head end electrode, and the head end electrode is arranged on the distal end surface of the anchor.

[0035] Optionally, the anchor is provided with a mounting hole, the head end electrode is provided in the mounting hole, and at least the distal end of the head end electrode protrudes from the distal end surface of the anchor.

[0036] Optionally, the ablation device further comprises a ring electrode, which is disposed at the distal end of the catheter body; or, the ring electrode is disposed on the sheath.

[0037] Optionally, one of the head-end electrode and the ring electrode is set as a positive electrode, and the other is set as a negative electrode, and the head-end electrode is used to form an electric field between the head-end electrode and the ring electrode.

[0038] Optionally, the flexible strips are arranged along the circumference of the catheter body, and the electrode polarity of the discharge structure on one of at least two adjacent flexible strips is opposite to the electrode polarity of the discharge structure on the other flexible strip.

[0039] Optionally, the ablation device further comprises a balloon, which is disposed in a space enclosed by the plurality of flexible strips, and is configured to contact the target tissue after being expanded.

[0040] Optionally, the ablation device further includes an adjusting member, which is movably disposed through the catheter body and connected to the anchoring member.

[0041] In some other embodiments, the present application further provides an ablation system, comprising:

[0042] a signal generator configured to generate a pulse waveform;

[0043] an ablation device coupled to the signal generator and configured to receive the pulse waveform, the ablation device comprising at least:

[0044] a catheter body having a centerline;

[0045] a functional component, the functional component being disposed at the distal end of the catheter body;

[0046] The functional component comprises at least a first state and a second state, and the functional component is at least partially configured to be movable along the axial direction of the catheter body to convert between the first state and the second state;

[0047] wherein the radial dimension of the functional component in the first form is greater than the radial dimension of the functional component in the second form;

[0048] an anchor member located at a distal end of the functional component, the anchor member being rotatably connected to the distal end of the functional component, wherein a rotation axis of the distal end of the functional component forms an angle with the center line;

[0049] At least part of the anchoring member is an insulating structure;

[0050] A handle is coupled to the catheter body.

[0051] The ablation device provided in some embodiments of the present application, when the functional component is in the second form or a form between the first form and the second form, and the discharge structure is not in contact with the target tissue or the contact is insufficient, can push the proximal end of the catheter body to make the anchor contact with the target tissue, the distal end of the flexible strip rotates relative to the anchor, and at least part of the position of the flexible strip can move radially away from the center line of the catheter body, the functional component is transformed at least toward the first form, and then the discharge structure on the flexible strip is in contact with the target tissue, and the discharge structure releases energy to achieve ablation of the target tissue. Compared with the method of fixing the distal end of the flexible strip together, the structure of the flexible strip and the anchor being movably connected is conducive to more labor-saving pushing of the catheter body 10, the target tissue is less deformed by the compression of the anchor, the operation is convenient, and it is conducive to improving the safety of the operation.

[0052] The ablation system provided in some embodiments of the present application can make surgery more convenient and safer through the provision of an ablation device. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 This is a schematic diagram of the structure of the ablation device provided in this application. Figure 1 ;

[0054] Figure 2 is a schematic diagram of the cross-sectional structure of the flexible strip provided in this application;

[0055] Figure 3 is a schematic diagram of the ablation device provided by the present application when the anchor member is in initial contact with the target tissue;

[0056] Figure 4 This is a schematic diagram of the contact between the functional component provided by the present application and the target tissue in the first form;

[0057] Figure 5 is a schematic diagram of the partial structure of the ablation device provided by the present application at the anchoring member;

[0058] Figure 6 It is a structural schematic diagram of the anchor provided in this application;

[0059] Figure 7 This is a schematic diagram of a partial structure in which a shaft segment is passed through the distal end of a flexible strip provided by the present application;

[0060] Figure 8 This is a schematic diagram of the partial structure of the distal end of the flexible strip provided with a convex shaft provided in the present application;

[0061] Figure 9 This is a schematic diagram of the electrode polarity distribution of the ablation device provided in this application. Figure 1 ;

[0062] Figure 10 This is a schematic diagram of the electrode polarity distribution of the ablation device provided in this application. Figure 2 ;

[0063] Figure 11 This is a schematic diagram of the structure of the ablation device provided in this application. Figure 2 ;

[0064] Figure 12 This is a schematic diagram of the partial structure of the ablation device provided by the present application at the flexible strip;

[0065] Figure 13 It is a structural schematic diagram of the catheter body provided by this application;

[0066] Figure 14 Schematic diagram of the structure of the ablation device with a balloon provided in this application;

[0067] Figure 15 This is a schematic diagram of the electrode polarity distribution of the ablation device provided in this application. Figure 3 ;

[0068] Figure 16 This is a schematic diagram of the structure of the ablation device with an adjustment member provided in this application. Figure 1 ;

[0069] Figure 17 This is a schematic diagram of the structure of the ablation device with an adjustment member provided in this application. Figure 2 ;

[0070] Figure 18 Schematic diagram of the ablation device (excluding the adjustment element) provided by the present application applied to cardiac sympathetic ablation;

[0071] Figure 19 This application provides Figure 18 A magnified schematic diagram of point A in the middle;

[0072] Figure 20 Schematic diagram of the ablation device (including the adjustment element) provided by the present application applied to cardiac sympathetic ablation;

[0073] Figure 21 This application provides Figure 20 A magnified schematic diagram of point B in the middle;

[0074] Figure 22 This application provides Figure 20 Enlarged schematic diagram of point C in the middle;

[0075] Figure 23 This application provides Figure 20 Enlarged schematic diagram of point D in the middle.

[0076] In the picture:

[0077] 1. Target tissue; 2. Sheath;

[0078] 10. Catheter body; 11. First channel; 12. Second channel;

[0079] 20. Functional component; 21. Flexible strip; 21a. First strip segment; 21b. Second strip segment;

[0080] 31. Discharge structure; 31a. Metal coating; 31b. Discharge electrode; 32. Insulation coating;

[0081] 40. Anchor member; 41. Gap groove; 42. First hinge hole; 43. Mounting groove; 44. Mounting hole; 45. Support block;

[0082] 51. Shaft section; 52. Cam shaft;

[0083] 60. Head end electrode;

[0084] 70. Ring electrode;

[0085] 80. Adjustment parts;

[0086] 90. Balloon. DETAILED DESCRIPTION

[0087] 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.

[0088] 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.

[0089] 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.

[0090] In the present application, the distal end refers to the end of the ablation device and at least some of the components constituting the ablation device that is exemplarily away from the operator when in use (or, the distal end refers to the end of the ablation device and at least some of the components constituting the ablation device that first contacts / intervenes with the biological tissue when used on the biological body), and the proximal end refers to the end of the ablation device and at least some of the components constituting the ablation device that is exemplarily close to the operator when in operation (or, the proximal end refers to the end of the ablation device and at least some of the components constituting the ablation device that is exemplarily farther away from the biological tissue than the distal end when used on the biological body).

[0091] Commonly used ablation techniques can be divided into traditional radiofrequency ablation, cryoablation, and the emerging pulsed ablation. Radiofrequency ablation typically uses a point-to-point approach, inducing necrosis of target tissue cells through heating; cryoablation utilizes the heat-absorbing vaporization of a liquefied refrigerant, significantly lowering the surrounding temperature and causing necrosis of target tissue cells.

[0092] Pulse ablation can generate microsecond to nanosecond pulsed electric fields during the ablation process to create microsecond to nanosecond micropores on the cell membrane, achieving "electroporation." Compared to smooth muscle and nerve cells, cardiomyocytes have the lowest threshold for pulsed electric fields, making them the first to die during pulsed electric field ablation. In other words, pulsed electric fields can selectively ablate myocardial tissue while preserving blood vessels, nerves, and tissues surrounding the heart. Furthermore, pulsed electric fields perform irreversible electroporation and ablation on myocardial tissue, requiring less or even no heat energy conduction, making the ablation process more efficient and faster, and shortening the ablation time.

[0093] For example, the ablation device used in pulse ablation using related technologies usually includes a plurality of flexible strips with electrodes installed. During the operation, if the flexible strips need to be deformed so that the position of the electrodes is suitable for abutting the surface of the myocardial wall (for example, when performing circumferential pulmonary vein isolation (PVI) ablation), the adjustment force required for the deformation of the flexible strips is relatively large, which may place high demands on the doctor's operation and may pose a risk of affecting the safety of the operation.

[0094] To solve at least one of the above problems, refer to Figure 1 and Figure 2 , Figure 1 This is a schematic diagram of the structure of the ablation device provided in at least one embodiment of the present application. Figure 1 , Figure 2 FIG2 is a schematic cross-sectional view of a flexible strip 21 provided in at least one embodiment of the present application. At least one embodiment of the present application provides an ablation device comprising a catheter body 10, a functional component 20, and an anchor 40. The functional component 20 is disposed at the distal end of the catheter body 10, and the anchor 40 is located distal to the functional component 20. The functional component 20 and the anchor 40 are rotatably connected.

[0095] In some embodiments, the functional component 20 includes a plurality of flexible strips 21, the proximal ends of the flexible strips 21 being connected to the distal end of the catheter body 10. The catheter body 10 has a centerline O, and at least a portion of the outer surface of at least some of the flexible strips 21, away from the centerline O, is provided with a discharge structure 31. The discharge structure 31 is used to apply energy to the target tissue 1 (e.g., during circumferential pulmonary vein isolation (PVI) ablation) or to read positional information or electrophysiological information of the target tissue 1.

[0096] It can be understood that the outer surface of the flexible strip 21 refers to the side of the flexible strip 21 facing away from the center line O of the catheter body 10 .

[0097] In some other embodiments, the discharge structure 31 is provided on the circumferential surface of the flexible strip 21. For example, at least part of the inner surface and at least part of the outer surface of the flexible strip 21 are provided with the discharge structure 31, and at least part of the side surface between the inner surface and the outer surface of the flexible strip 21 is also provided with the discharge structure 31.

[0098] Exemplarily, the functional component 20 includes three to eight flexible strips 21, such as five or six. Of course, the number of the flexible strips 21 can also be other values, such as one, two, ten, etc., which is not limited in this application.

[0099] In some embodiments, the functional component 20 includes at least a first configuration and a second configuration. The functional component 20 is configured such that at least the distal end of the flexible strip 21 can move axially along the catheter body 10 to transition between the first configuration and the second configuration. In the first configuration, at least a portion of the flexible strip 21 can move a first distance in the radial direction of the catheter body 10 away from the centerline O. In the second configuration, at least a portion of the flexible strip 21 can move a second distance in the radial direction of the catheter body 10 away from the centerline O, with the first distance being greater than the second distance. It will be appreciated that the shape of the flexible strip 21 is adjustable (e.g., the degree of axial movement of the functional component 20 (e.g., the distal end of the functional component 20) along the catheter body 10 can be adjusted) to better align the discharge structure 31 with the target tissue 1.

[0100] For example, in the first configuration, the flexible strip 21 (e.g., the middle portion of the flexible strip 21) is arched away from the centerline O of the catheter body 10, such that the multiple arched flexible strips 21 can form a basket or petal structure. In the second configuration, the flexible strip 21 is straight; in other words, the length of the flexible strip 21 is approximately parallel to the length of the catheter body 10. Alternatively, in the second configuration, the flexible strip 21 is arched away from the centerline O of the catheter body 10, such that the multiple arched flexible strips 21 can form a cage-like structure, but the extent of the arching of the flexible strip 21 in the second configuration is smaller than that in the first configuration.

[0101] Illustratively, compared to the functional component 20 in the second form, the discharge structure 31 on the flexible strip 21 of the functional component 20 in the first form is suitable for ablation of a large area of ​​the target tissue 1 (for example, when performing circumferential pulmonary vein isolation (PVI) ablation).

[0102] In some embodiments, at least the thickness B1 of the distal end of the flexible strip 21 is greater than the thickness B2 of the proximal end of the flexible strip 21 , which facilitates the rotational connection between the flexible strip 21 and the anchor 40 and improves the structural rigidity of the flexible strip 21 .

[0103] In some embodiments, the flexible strip 21 includes at least a first segment 21a and a second segment 21b. The proximal end of the first segment 21a is connected to the distal end of the second segment 21b, which is rotatably connected to the anchor 40. The proximal end of the second segment 21b is connected to the distal end of the catheter body 10. In a first configuration, the first segment 21a is configured as an arc-shaped structure that convexly extends from a side proximal to the centerline O of the catheter body 10 toward a side distal to the centerline O of the catheter body 10. This facilitates the flexible strip 21 to curve away from the centerline O of the catheter body 10, thereby improving contact between the discharge structure 31 and the target tissue 1. The second segment 21b curves in an opposite direction from the first segment 21a, which helps improve the compactness of the proximal end of the functional component 20 and facilitates the retraction of the functional component 20 into the sheath 2 (described in more detail below). The second segment 21b can be composed of multiple arcs with varying radii of curvature, or it can be configured as a single arc.

[0104] In some embodiments, the first segment 21a and the second segment 21b are integrally formed.

[0105] In some embodiments, at least a portion of the flexible strip 21 is constructed of an elastic material, or a memory strip is provided on the flexible strip 21 (e.g., at least a portion of the memory strip is disposed inside or outside the flexible strip 21). The memory strip is constructed of an elastic material to enable the flexible strip 21 to contract or expand radially. This means that the functional component 20 has radial expansion capabilities, can be compressed under an external force, and can self-expand or mechanically expand to return to and maintain its original shape after the external force is removed. Elastic materials include, but are not limited to, nickel-titanium alloys, nickel-titanium superelastic alloys, cobalt-chromium-nickel-molybdenum alloys, copper-based shape memory alloys, iron-based shape memory alloys, medical stainless steel alloys, or various polymers (e.g., polynorbornene, polyurethane, polylactic acid copolymer, etc.).

[0106] In some embodiments, the anchor 40 is rotatably connected to the distal end of the flexible strip 21, and the rotation axis of the distal end of the flexible strip 21 has an angle with the center line O to facilitate the flexible strip 21 to bend or transform into a straight strip, which is beneficial to the shape transformation of the functional component 20.

[0107] In some embodiments, at least a portion of the anchor 40 is an insulating structure, which helps reduce the risk of electrical conduction between the distal ends of the multiple flexible strips 21, allowing the discharge structure 31 on each flexible strip 21 to independently serve as a discharge electrode. For example, the entire anchor 40 can be an insulating structure, or a portion of the anchor 40 can be an insulating structure, or the surface of the anchor 40 can be coated with an insulating material.

[0108] Exemplarily, the rotation axis of the distal end of the flexible strip 21 is perpendicular to the center line O, which is more conducive to the shape transformation of the functional component 20.

[0109] For example, the anchoring member 40 may be made of insulating plastic, which is convenient for molding and manufacturing.

[0110] In some exemplary embodiments, when the functional component 20 is in the second configuration or another configuration between the first and second configurations, the discharge structure 31 is not in contact with the target tissue 1 or the contact is insufficient. The proximal end of the catheter body 10 can be pushed against the anchor 40 to cause the anchor 40 to contact the target tissue 1. The distal end of the flexible strip 21 rotates relative to the anchor 40, allowing at least a portion of the flexible strip 21 to move radially away from the centerline O of the catheter body 10. The functional component 20 is transformed toward at least the first configuration, thereby causing the discharge structure 31 on the flexible strip 21 to contact the target tissue 1. Compared to a configuration in which the distal end of the flexible strip 21 is fixed together, the flexible strip 21 and the anchor 40 are movably connected, which facilitates pushing against the catheter body 10 with less effort, thereby minimizing the deformation of the target tissue 1 caused by the anchor 40, facilitating operation, and improving surgical safety.

[0111] For example, Figure 3 and Figure 4 As shown, Figure 3 is a schematic diagram of the ablation device provided by at least one embodiment of the present application when the anchor 40 is in initial contact with the target tissue 1. Figure 4 Schematic diagram of the contact between the functional component 20 and the target tissue 1 in the first state provided by at least one embodiment of the present application. In some states of the functional component 20, the discharge structure 31 of the functional component 20 does not abut against the target tissue 1 or the abutment is poor, pushing against the proximal end of the catheter body 10, causing the functional component 20 to deform (such as causing the functional component 20 to transform into the first state), thereby facilitating the abutment between the discharge structure 31 on the flexible strip 21 and the target tissue 1. For example, Figure 3 As shown, the discharge structure 31 is not in contact with the target tissue 1, and pushes against the proximal end of the catheter body 10, so that the functional component 20 can be Figure 3 The spherical shape shown is converted to Figure 4 The ellipsoidal shape shown enables the discharge structure 31 on the flexible strip 21 to be in contact with the target tissue 1 .

[0112] In some exemplary embodiments, the ablation device can be delivered to the target tissue 1 through the sheath 2. Within the ablation device, the functional component 20 is squeezed by the inner wall of the sheath 2 to assume a second shape or nearly assume the second shape. When the functional component 20 is separated from the distal end of the sheath 2, the flexible strip 21 arches under its own elastic action (or the deformation of the functional component 20 is achieved by controlling the catheter body 10), causing the functional component 20 to transform into the first shape, or other shapes between the first shape and the second shape. When at least the functional component 20 needs to be retracted into the sheath 2, the proximal end of the catheter body 10 can be pulled. The flexible strip 21 is squeezed by the inner wall of the sheath 2 and can move radially toward the centerline O of the catheter body 10 and contract. During this process, the distal end of the flexible strip 21 rotates relative to the anchor 40. Compared with the method in which the distal end of the flexible strip 21 is fixed together, the structure in which the flexible strip 21 and the anchor 40 are movably connected facilitates pulling the catheter body 10 with less effort, facilitates operation, and helps improve the safety of the operation.

[0113] In some embodiments, please refer to Figure 5 and Figure 6 , Figure 5 is a schematic diagram of the partial structure of the ablation device at the anchor 40 provided in at least one embodiment of the present application. Figure 6 The figure is a schematic diagram of the structure of an anchor member 40 provided in at least one embodiment of the present application. The anchor member 40 is provided with a plurality of clearance grooves 41 spaced apart along the circumference of the functional component 20. The clearance grooves 41 extend through at least one sidewall of the anchor member 40 away from the centerline O. The number of flexible strips 21 corresponds to the number of clearance grooves 41, and the distal ends of the flexible strips 21 are movably hinged within corresponding clearance grooves 41.

[0114] In some embodiments, the clearance groove 41 at least passes through the proximal surface of the anchoring member 40 .

[0115] In some embodiments, the clearance groove 41 at least passes through the distal end surface of the anchoring member 40 .

[0116] For example, the clearance groove 41 may be U-shaped or arc-shaped.

[0117] In some embodiments, the clearance groove 41 allows the anchor 40 to clear the distal end of the flexible strip 21, resulting in a compact structure that helps reduce the radial dimension of the ablation device at the anchor 40, facilitating delivery of the ablation device. The clearance groove 41 extends through the proximal surface of the anchor 40, flattening the shape of the ablation device at the anchor 40 and further reducing the radial dimension of the ablation device at the anchor 40. The clearance groove 41 extends through the distal surface of the anchor 40, reducing the risk of the anchor 40 interfering with the distal rotation of the flexible strip 21.

[0118] In some embodiments, a support block 45 is provided between two adjacent clearance slots 41 along the circumference of the functional component 20. First hinge holes 42 are provided on both side walls of the support block 45. These first hinge holes 42 communicate with adjacent clearance slots 41, such that any clearance slot 41 is provided with two corresponding first hinge holes 42. The two first hinge holes 42 connected to the clearance slots 41 on the anchor 40 are configured to hinge with the distal ends of the corresponding flexible strips 21.

[0119] In one embodiment, a limiting groove 41 is formed between two adjacent support blocks 45 to reduce the risk of the distal end of the flexible strip 21 sliding along the rotation axis, so that the flexible strip 21 is evenly distributed along the circumference of the functional component 20, thereby facilitating improving the ablation uniformity of the ablation device.

[0120] In another embodiment, along the circumference of the anchor 40, the circumferential length of the clearance groove 41 between two adjacent support blocks 45 is greater than the circumferential length of the distal end of the flexible strip 21, so that the distal end of the flexible strip 21 can fully move in the corresponding clearance groove 41, which may be beneficial.

[0121] In one embodiment, please refer to Figure 5 Combined with Figure 7 As shown, Figure 7 This is a partial structural diagram of a flexible strip 21 provided in at least one embodiment of the present application, in which a shaft segment 51 is passed through the distal end. The ablation device also includes a rotating shaft, which includes multiple shaft segments 51. At least one shaft segment 51 is corresponding to a clearance groove 41, and the two ends of at least one shaft segment 51 in its own length direction are arranged in two first hinge holes 42 connected to the corresponding clearance groove 41, so as to facilitate the assembly between the rotating shaft and the anchor 40. The distal end of the flexible strip 21 is arranged in the shaft segment 51 in the corresponding clearance groove 41, and the length direction of the shaft segment 51 is the rotation axis of the flexible strip 21. The flexible strip 21 and the anchor 40 are hinged by the rotating shaft, which is convenient for assembly and conducive to structural stability and reliability.

[0122] Exemplarily, the distal end of the flexible strip 21 is provided with a second hinge hole, which is movably sleeved on the shaft segment 51 in the corresponding give way groove 41, or the distal end of the flexible strip 21 is fixed (such as by bonding, welding, mortise and tenon structure, rivet mechanism, etc.) on the shaft segment 51 in the corresponding give way groove 41, and the length direction of the shaft segment 51 is the rotation axis of the flexible strip 21.

[0123] Illustratively, at least the thickness B1 of the distal end of the flexible strip 21 is greater than the thickness B2 of the proximal end of the flexible strip 21 , which can facilitate the formation of the second hinge hole and help improve the stability of the flexible strip 21 during deformation.

[0124] In another embodiment, the multiple shaft segments 51 of the rotating shaft are integrally formed into a rod-shaped object, and the rotating shaft passes through the first hinge hole 42 on each support block 45 along the circumference of the functional component 20 to facilitate the hinge between the flexible strip 21 and the anchor 40.

[0125] In another embodiment, please refer to Figure 8 , Figure 8 This is a partial structural diagram of the distal end of a flexible strip 21 provided with a protruding shaft 52, according to at least one embodiment of the present application. The protruding shaft 52 is provided at the distal end of the flexible strip 21. The protruding shaft 52 is positioned at its longitudinal ends within two first hinge holes 42 connected to corresponding clearance slots 41, facilitating the hinged connection between the flexible strip 21 and the anchor 40. The longitudinal direction of the protruding shaft 52 serves as the rotational axis of the flexible strip 21.

[0126] Exemplarily, the protruding shaft 52 is integrally formed and is arranged at the distal end of the flexible strip 21; or, the protruding shaft 52 includes a first sub-shaft and a second sub-shaft, and the first sub-shaft and the second sub-shaft are respectively arranged on both sides of the flexible strip 21 along the circumference of the functional component 20, and the ends of the first sub-shaft and the second sub-shaft away from the flexible strip 21 along the circumference of the functional component 20 are respectively arranged in two first hinge holes 42 connected to the corresponding give way grooves 41, so as to facilitate the hinge between the flexible strip 21 and the anchor 40.

[0127] Exemplarily, the protruding shaft 52 is fixedly connected to the flexible strip 21 , and the protruding shaft 52 is relatively small in size, which can reduce the risk of the protruding shaft 52 being separated from the flexible strip 21 and lost during the assembly process.

[0128] In some embodiments, the support block 45 is provided with a mounting slot 43, which is connected to two first hinge holes 42 on the support block 45. For example, in the case of a hinged connection between the flexible strip 21 and the anchor 40 via a rotating shaft (with multiple shaft segments 51 being independent of each other, i.e., not integrally formed), the ends of the shaft segments 51 along their own length are fixed (e.g., by bonding, welding, mortise and tenon structure, rivet mechanism, etc.) to the corresponding mounting slot 43 on the support block 45 to reduce the risk of the rotating shaft detaching from the flexible strip 21 and the anchor 40, thereby reducing the difficulty of the process of attaching the rotating shaft to the anchor 40. It is understood that the shaft segments 51 can be inserted into the first hinge holes 42 at the mounting slots 43 to facilitate the hinged connection between the flexible strip 21 and the anchor 40.

[0129] In some embodiments, the outer diameter of the anchor 40 is less than or equal to the outer diameter of the catheter body 10 to facilitate at least partial retraction of the ablation device into the sheath 2. Of course, the outer diameter of the anchor 40 can also be greater than the outer diameter of the catheter body 10, which is not limited in this application.

[0130] In some embodiments, when the functional component 20 is in the second configuration, at least a portion of the outer surface of the flexible strip 21 protrudes from the support block 45 along the radial direction of the anchor 40 to facilitate at least a portion of the ablation device to be retracted into the sheath 2 .

[0131] In some embodiments, please refer to Figure 6 Combined with Figure 9 As shown, Figure 9 This is a schematic diagram of the electrode polarity distribution of the ablation device provided in at least one embodiment of the present application. Figure 1 The ablation device further includes a tip electrode 60, which is disposed on the distal surface of the anchor 40. The tip electrode 60 is used to apply energy to the target tissue 1 (e.g., to perform localized and precise ablation of a specific lesion in the atrium) or to read the position information or electrophysiological information of the target tissue 1.

[0132] In some embodiments, one of the discharge structure 31 and the head end electrode 60 is set as the positive pole, and the other is set as the negative pole, and the head end electrode 60 is used to form an electric field between it and all the discharge structures 31, so as to achieve potential mapping of the target tissue 1 along the axial direction of the catheter body 10.

[0133] In some embodiments, the anchor 40 is provided with a mounting hole 44, into which the tip electrode 60 is disposed for ease of assembly. At least the distal end of the tip electrode 60 protrudes beyond the distal surface of the anchor 40 to facilitate contact with the target tissue 1. The mounting hole 44 can be located at or off the center of the anchor 40, and this is not a limitation in this application.

[0134] In some embodiments, the head electrode 60 may be provided with a through hole (not shown), which is at least used to pass a guide wire through the through hole. The guide wire can guide the ablation device to move toward the target tissue 1.

[0135] In some embodiments, the ablation device has two operating modes: a mapping mode and an ablation mode. In the mapping mode, the ablation device reads the position information or electrophysiological information of the target tissue 1. In the ablation mode, the ablation device applies energy to the target tissue 1 to ablate the target tissue 1.

[0136] In some embodiments, please refer to Figure 10 , Figure 10 This is a schematic diagram of the electrode polarity distribution of the ablation device provided in at least one embodiment of the present application. Figure 2 The flexible strips 21 are arranged along the circumference of the catheter body 10. The electrode polarity of the discharge structure 31 on at least some adjacent flexible strips 21 is opposite to that of the discharge structure 31 on the other, forming a bipolar staggered discharge. This facilitates a more uniform electric field distribution. This reduces the risk of electroporation during the application of energy to the target tissue 1 and improves surgical safety.

[0137] For example, the same discharge structure 31 can switch between positive and negative polarity. In other words, the discharge structure 31 on a flexible strip 21 can be either positive or negative. The switchable electrode polarity of the discharge structure 31 enables the functional component 20 to generate a pulsed electric field, thereby achieving pulsed ablation therapy.

[0138] For example, taking the case where the number of flexible strips 21 is even and all flexible strips 21 are provided with discharge structures 31 , the positive discharge structures 31 and the negative discharge structures 31 are alternately arranged along the circumference of the catheter body 10 .

[0139] For example, taking the case where the number of flexible strips 21 is an odd number and not less than 3, and all flexible strips 21 are provided with a discharge structure 31, along the circumference of the catheter body 10, the functional component 20 has two discharge structures 31 with the same electrode polarity and adjacent positions.

[0140] In one embodiment, please refer to Figure 11 , Figure 11 This is a schematic diagram of the structure of the ablation device provided in at least one embodiment of the present application. Figure 2 The discharge structure 31 is configured as a flexible circuit, on which a discharge electrode 31 b is provided. The flexible circuit is conveniently attached to the outer surface of the flexible strip 21 .

[0141] Exemplarily, at least one discharge electrode 31 b is provided on the flexible circuit. For example, the flexible circuit is provided with a plurality of discharge electrodes 31 b spaced apart along its length direction.

[0142] In another embodiment, please refer to Figure 9 Combined with reference Figure 12 , Figure 12 This is a schematic diagram of the partial structure of the flexible strip 21 of an ablation device provided in at least one embodiment of the present application. The discharge structure 31 is configured as a metal coating 31a containing at least gold. The metal coating 31a has a large surface area, providing good contact with the target tissue 1 and a good discharge effect, thereby increasing the voltage applied to the target tissue 1. Furthermore, the metal coating 31a exhibits excellent anti-oxidation properties, which helps reduce the risk of oxidation affecting treatment effectiveness, such as the risk of insufficient ablation depth.

[0143] For example, the material of the flexible strip 21 may be a metal material, or the flexible strip 21 may be an insulating material, which is not limited in this application.

[0144] Exemplarily, the flexible strip 21 can be cut from materials such as nickel titanium or stainless steel tubes. A metal tube is evenly cut into multiple petals using a laser cutting machine. Each petal is subsequently sandblasted to remove the surface oxide layer, and the edge burrs formed by the cutting are smoothed by chemical polishing, and then a metal coating 31a is plated.

[0145] For example, the metal coating 31a may be a mixed coating containing at least one of silver, palladium, platinum and tantalum in addition to gold.

[0146] In some embodiments, continue with reference to Figure 12 As shown, except for the surface provided with the metal coating 31a on the flexible strip 21, at least part of the remaining surface is coated with an insulating coating 32. It is understandable that the area of ​​the flexible strip 21 provided with the metal coating 31a is an active area, which can be used to contact the target tissue 1, with good contact and discharge effects, and can transmit energy to the target tissue 1. The area of ​​the flexible strip 21 provided with the insulating coating 32 is an insulating area, which is beneficial for reducing the risk of empty discharge, the risk of hemolysis and barotrauma, and the risk of blood scab and coagulation on the electrode surface, thereby reducing the risk of thrombosis and achieving a good ablation effect. It is understandable that when the material of the flexible strip 21 is an insulating material, the insulating coating 32 may not be provided on the flexible strip 21.

[0147] In some embodiments, along the length of the flexible strip 21, at least the flexible strip 21 is provided with insulating regions on both sides of the discharge structure 31. The length of the insulating region near the distal end of the flexible strip 21 is shorter than the length of the insulating region near the proximal end of the flexible strip 21. For example, the length of the insulating region near the distal end of the flexible strip 21 is 2-8% of the length of the flexible strip 21, and the length of the insulating region near the proximal end of the flexible strip 21 is 8-15% of the length of the flexible strip 21. Because the distal end of the flexible strip 21 is articulated via the anchor 40, the rotation direction of the flexible strip 21 is as far away from the centerline O of the catheter body 10 as possible. Therefore, providing the insulating region near the distal end of the flexible strip 21 helps reduce the risk of arc discharge due to the close proximity of the distal ends of the flexible strip 21, which may cause undesirable treatment side effects. In addition, the length of the insulating region near the distal end of the flexible strip 21 is shorter than the length of the insulating region near the proximal end of the flexible strip 21, which helps achieve both a larger ablation area and better adhesion of the active area.

[0148] Illustratively, the insulating coating 32 includes, but is not limited to, a PTFE insulating coating 32, a parylene insulating coating 32, a ceramic insulating coating 32, a silicone insulating coating 32, or a glass insulating coating 32. Illustratively, the insulating coating 32 may also be composed of other non-conductive, bipolar materials. Illustratively, the coatings on both ends of the flexible strip 21 in the longitudinal direction may be a hydrophilic polymer material.

[0149] In some embodiments, the insulating material coated on the surface of the anchor 40 can be the same as the material of the insulating coating 32 .

[0150] In some embodiments, please refer to Figure 13 , Figure 13 Schematic diagram of the structure of a catheter body according to at least one embodiment of the present application. The catheter body 10 includes a first channel 11 extending through the length thereof. The first channel 11 can be used to pass a guide wire.

[0151] In some embodiments, the catheter body 10 also includes a plurality of second channels 12 distributed around the periphery of the first channel 11 and extending through the length direction of the catheter body 10. The number of the second channels 12 corresponds to the number of the flexible strips 21, and the proximal end of the flexible strip 21 is inserted into the corresponding second channel 12 for easy assembly.

[0152] For example, the cross-sections of the flexible strip 21 and the second channel 12 may both be fan-shaped.

[0153] Exemplarily, the catheter body 10 may be made of a polymer material.

[0154] Exemplarily, the catheter body 10 and the flexible strip 21 can be fixed by bonding, or the catheter body 10 can be fixed to the flexible strip 21 by heat shrinkage or other methods (such as welding, mortise and tenon structure, rivet mechanism, etc.), which is not limited in this application.

[0155] In some embodiments, the discharge structure 31 can be coupled to a signal generator (not shown). The signal generator is configured to generate a pulse waveform, and the discharge structure 31 is configured to receive the pulse waveform. The signal generator provides energy to the discharge structure 31. The signal generator is prior art and is not the focus of this embodiment, so its detailed description is omitted here.

[0156] In some embodiments, the proximal end of the flexible strip 21 can be coupled to the signal generator via a first wire (not shown). The number of first wires corresponds to the number of flexible strips 21. The first wires can be inserted into the second channel 12 into which the corresponding flexible strip 21 is inserted. For example, the pulse waveform generated by the signal generator can be received by the discharge structure 31 after passing through the first wire and the flexible strip 21 in sequence.

[0157] In some embodiments, please refer to Figure 14 , Figure 14FIG2 is a schematic diagram of the structure of an ablation device including a balloon 90, provided in at least one embodiment of the present application. The ablation device further includes balloon 90, which is disposed within the space enclosed by multiple flexible strips 21. Balloon 90 is configured to inflate and contact target tissue 1. Balloon 90 is inflated by a medium. The filled balloon 90 helps the flexible strips 21 maintain their arched shape, facilitates blood displacement, and reduces damage to red blood cells.

[0158] In some embodiments, please refer to Figure 15 , Figure 15 This is a schematic diagram of the electrode polarity distribution of the ablation device provided in at least one embodiment of the present application. Figure 3 The ablation device further includes a ring electrode 70 , which is disposed at the distal end of the catheter body 10 .

[0159] In some other embodiments, the ring electrode 70 is disposed on the sheath 2 (eg, at the distal end of the sheath 2 ). It is understood that the sheath 2 may be a part of the ablation device. In other words, the ablation device includes the sheath 2 .

[0160] In some embodiments, one of the head end electrode 60 and the ring electrode 70 is set as a positive electrode, and the other is set as a negative electrode, and an electric field is formed between the head end electrode 60 and the ring electrode 70 .

[0161] Exemplarily, the head electrode 60 is used as the positive electrode and the ring electrode 70 is used as the negative electrode, which can achieve single-point or supplementary ablation of the target tissue 1. For example, during single-point ablation and supplementary ablation, the discharge structure 31 does not work. Among them, single-point ablation refers to the application of a pulsed electric field at a specific target location. The head-end electrode 60 can release high-frequency and high-voltage pulse energy to cause irreversible electroporation of the target tissue 1, thereby achieving ablation of smaller tissues. Among them, supplementary ablation refers to supplementary ablation of the target tissue 1 that has not been completely ablated or requires further treatment after the initial ablation.

[0162] In some embodiments, please refer to Figure 16 and Figure 17 , Figure 16 This is a schematic diagram of the structure of the ablation device with the adjustment member 80 provided in at least one embodiment of the present application. Figure 1 , Figure 17 This is a schematic diagram of the structure of the ablation device with the adjustment member 80 provided in at least one embodiment of the present application. Figure 2 , wherein the functional component 20 includes at least a third form, and the deformation degree of the functional component 20 in the third form at least in the radial direction is less than the deformation degree of the functional component 20 in the first form at least in the radial direction. The third form is between the first form and the second form. In other words, the deformation degree of the functional component 20 in the third form at least in the radial direction is greater than the deformation degree of the functional component 20 in the second form at least in the radial direction. For example Figure 17 The bending amplitude of the flexible strip 21 of the functional component 20 is greater than Figure 16 The ablation device further includes at least one adjusting member 80, which is movably provided in the catheter body 10 and connected to the anchor 40. It is understandable that the adjusting member 80 moves relative to the catheter body 10 along the axial direction of the catheter body 10, and can at least drive the distal end of the flexible strip 21 to move through the anchor 40, which is conducive to making the conversion of the functional component 20 between the first form and the second form more flexible, stable and reliable, helping to make the surgical operation more convenient, and helping to reduce the surgical time, surgical difficulty and risks during the operation. Among them, the adjusting member 80 is movably provided in the first channel 11 of the catheter body 10.

[0163] In some other embodiments, when the ablation device does not include the adjusting member 80, the maximum circumscribed circle diameter of the functional component 20 is 5 mm-20 mm; when the ablation device includes the adjusting member 80, the circumscribed circle diameter of the functional component 20 may be greater than 15 mm.

[0164] In other embodiments, the head electrode 60 is stepped, comprising a stem portion (not shown) and a head portion (not shown) connected to each other. The stem portion has a smaller diameter than the head portion. It is understood that the stem portion is disposed on the proximal surface of the head portion. The stem portion passes through the mounting hole 44 and is connected to the adjustment member 80. The proximal surface of the head portion abuts against the anchor member 40, facilitating the fixing of the anchor member 40, the head electrode 60, and the adjustment member 80.

[0165] Exemplarily, the adjusting member 80 can be a tubular structure, that is, the adjusting member 80 has an internal channel (not shown) through which a guide wire can be passed; or, the adjusting member 80 is a solid rod-shaped structure, and the number of adjusting members 80 is 2-4, or other numbers greater than 4.

[0166] For example, the rod portion of the head end electrode 60 can be inserted into the internal channel or sleeved on the outside of the adjustment member 80 to facilitate assembly.

[0167] For example, the distal end of the adjusting member 80 and the head end electrode 60 may be fixed by laser welding, which is conducive to stability and reliability.

[0168] In some embodiments, the head end electrode 60 can be coupled to a signal generator, and the head end electrode 60 is configured to receive a pulse waveform generated by the signal generator.

[0169] In one embodiment, the head end electrode 60 may be coupled to the signal generator via the adjustment member 80 , that is, the adjustment member 80 may serve as a conductive medium, and the pulse waveform emitted by the signal generator is transmitted to the head end electrode 60 via the adjustment member 80 .

[0170] In another embodiment, the adjusting member 80 can be a braided composite tube structure, that is, the adjusting member 80 is an insulating tube, and the internal channel of the adjusting member 80 can be electroplated, such as gold plating or silver plating, so that the adjusting member 80 has good conductivity, thereby realizing the coupling of the head end electrode 60 with the signal generator through the adjusting member 80.

[0171] In some embodiments, as Figure 18 and Figure 19 As shown, Figure 18 is an exemplary schematic diagram of the ablation device (excluding the adjustment member 80) provided in at least one embodiment of the present application applied to cardiac sympathetic ablation. Figure 19 At least one embodiment of this application provides Figure 18 An enlarged schematic diagram of point A in the middle. Taking cardiac sympathetic ablation as an example, the distal end of sheath 2 can be delivered to the heart via blood vessels, and the distal end of the ablation device can be guided into the heart through sheath 2. For example, when the ablation device is delivered within sheath 2, flexible strip 21 is squeezed by the inner wall of sheath 2 to maintain a straight strip shape or a slightly curved shape (e.g., functional component 20 assumes the second configuration). In other words, functional component 20 can be delivered within sheath 2 in the second configuration.

[0172] For example, when at least the functional component 20 is separated from the distal end of the sheath 2, the flexible strip 21 arches under its own elastic action (or the deformation of the functional component 20 is achieved by controlling the catheter body 10), so that the functional component 20 is transformed into at least a shape between the first shape and the second shape. If the discharge structure 31 is not in contact with the target tissue 1 or the contact is insufficient due to the small arch angle of the flexible strip 21, the proximal end of the catheter body 10 can be pushed to make the anchor 40 contact the surface of the myocardial wall. The distal end of the flexible strip 21 rotates relative to the anchor 40, causing the flexible strip 21 to continue to arch a certain amplitude. The myocardial wall will also move closer to the discharge structure 31 under the resistance of the anchor 40, thereby achieving contact between the discharge structure 31 and the target tissue 1. The discharge structure 31 can transmit the released energy to the target tissue 1 to achieve ablation of the target tissue 1.

[0173] In some embodiments, after the discharge structure 31 completes ablation of the target tissue 1, at least the distal end of the ablation device needs to be retracted into the sheath 2. By pulling the proximal end of the catheter body 10, the flexible strip 21, squeezed by the inner wall of the sheath 2, can move radially toward the centerline O of the catheter body 10. During this process, the distal end of the flexible strip 21 rotates relative to the anchor 40, and at least a portion of the functional component 20 gradually retracts into the sheath 2. Once the distal end of the ablation device is retracted into the sheath 2, the ablation device can be removed from the body along with the sheath 2.

[0174] In some embodiments, as Figure 20 As shown, Figure 20This is an exemplary schematic diagram of the ablation device (including the adjustment member 80) provided in at least one embodiment of the present application being applied to cardiac sympathetic ablation. Taking cardiac sympathetic ablation as an example, the distal end of the sheath 2 can be delivered to the heart through the blood vessels, and the distal end of the ablation device can be guided into the heart through the sheath 2. For example, when the ablation device is delivered in the sheath 2, the adjustment member 80 can be used to keep the flexible strip 21 in a straight strip shape or a slightly arched shape (such as the functional component 20 presents the second form). It can be understood that the anchor 40 is rotatably connected to the distal end of the flexible strip 21, and the adjustment member 80 makes it easier to keep the functional component 20 in the second form, facilitates the delivery of the ablation device in the sheath 2, and helps to reduce the operation time, the difficulty of the operation and the risks during the operation. For example, when at least the functional component 20 is separated from the distal end of the sheath 2, the arch amplitude of the flexible strip 21 can be adjusted by the adjustment member 80, so that the discharge structure 31 is suitable for being close to the target tissue 1.

[0175] For example, when the flexible strip 21 needs to be retracted into the sheath 2, the adjusting member 80 can be pushed against first, so that the anchor 40 drives the flexible strip 21 to convert into a straight strip. During this process, because the distal end of the flexible strip 21 rotates relative to the anchor 40, pushing against the adjusting member 80 is more labor-saving than when the distal end of the flexible strip 21 is fixed together, which helps to reduce surgical time, surgical difficulty, and risks during the operation. When the shape of the flexible strip 21 is suitable for retracting the sheath 2, the catheter body 10 and the adjusting member 80 are pulled back to complete the operation.

[0176] In some embodiments, please refer to Figure 21 and Figure 22 As shown, Figure 21 At least one embodiment of this application provides Figure 20 The enlarged schematic diagram of point B in the middle is shown in Figure 2. Figure 22 At least one embodiment of this application provides Figure 20 In order to make the discharge structure 31 close to the target tissue 1 of different shapes, the bending amplitude of the flexible strip 21 can be adjusted by the adjusting member 80. For example, the flexible strip 21 can be adjusted to the following position by the adjusting member 80: Figure 21 The bending amplitude shown in the figure is such that the shape of the functional component 20 is suitable for the discharge structure 31 to act on the target tissue 1 at the pulmonary vein with a smaller aperture. For example, the flexible strip 21 is adjusted to the following position by the adjusting member 80: Figure 22 The shown arched extent is such that the shape of the functional component 20 is adapted to the contact of the target tissue 1 at the pulmonary vein with a larger aperture when the discharge structure 31 acts on it.

[0177] In some embodiments, please refer to Figure 23 As shown, Figure 23 At least one embodiment of this application provides Figure 20The flexible strip 21 is adjusted to a straight strip or slightly curved shape by the adjusting member 80, so that the tip electrode 60 on the anchor 40 can ablate a single point or multiple points of the target tissue 1, reducing the risk of the functional component 20 interfering with the contact between the tip electrode 60 and the target tissue 1.

[0178] This embodiment also provides an ablation system, which includes an ablation device of any of the above-mentioned embodiments (or examples) or a combination of any of the above-mentioned embodiments (or examples). The ablation system can make the operation more convenient and safer through the provision of the ablation device.

[0179] In some embodiments, the ablation system further includes a signal generator configured to generate a pulse waveform, and the ablation device is coupled to the signal generator and configured to receive the pulse waveform. The pulse waveform generated by the signal generator can be transmitted to at least the discharge structure 31 or the tip electrode 60 of the ablation device to achieve ablation of the target tissue 1.

[0180] In some embodiments, the ablation system further includes a handle coupled to the catheter body 10 , which can be used to control the operating mode of the ablation device (e.g., mapping mode and ablation mode) to facilitate surgical operation. The handle is conventional and will not be described in detail herein.

[0181] 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.

[0182] 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.

[0183] 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.

[0184] 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.

[0185] 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.

[0186] 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.

[0187] 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.

[0188] 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: include: a catheter body having a centerline; a functional component, the functional component being disposed at the distal end of the catheter body; The functional component includes a plurality of flexible strips, the proximal ends of the flexible strips are connected to the distal end of the catheter body, and at least a portion of the outer surface of at least a portion of the flexible strips away from the center line is provided with a discharge structure; The functional component includes at least a first state and a second state, and the functional component is configured so that at least the distal end of the flexible strip can move along the axial direction of the catheter body to convert between the first state and the second state; Wherein, in the first configuration, at least a portion of the flexible strip is capable of moving a first distance in a radial direction of the catheter body away from the centerline; In the second configuration, at least a portion of the flexible strip is movable a second distance in a radial direction of the catheter body away from the centerline, the first distance being greater than the second distance; an anchor member located at a distal end of the functional component, the anchor member being rotatably connected to the distal end of the flexible strip, the rotation axis of the distal end of the flexible strip being at an angle to the centerline; At least a portion of the anchoring member is an insulating structure.

2. The ablation device according to claim 1, wherein: The rotation axis of the distal end of the flexible strip is perpendicular to the centerline.

3. The ablation device according to claim 1, wherein: At least the thickness of the distal end of the flexible strip is greater than the thickness of the proximal end of the flexible strip.

4. The ablation device according to claim 1, wherein: The flexible strip comprises at least a first strip segment and a second strip segment, the proximal end of the first strip segment is connected to the distal end of the second strip segment, the distal end of the first strip segment is rotatably connected to the anchor, and the proximal end of the second strip segment is connected to the distal end of the catheter body; In the first form, the first segment is configured to be an arc-shaped structure convex from a side close to the center line of the catheter body to a side away from the center line of the catheter body; The bending direction of at least part of the second segment is opposite to the bending direction of the first segment.

5. The ablation device according to claim 1, wherein: The anchor is provided with a plurality of clearance grooves at intervals along the circumference of the functional component, and the clearance grooves are at least in the form of penetrating a side wall of the anchor away from the center line; The number of the flexible strips is arranged in a one-to-one correspondence with the number of the clearance grooves, and the distal ends of the flexible strips are movably hinged in the corresponding clearance grooves.

6. The ablation device according to claim 5, characterized in that The clearance groove at least penetrates the proximal end surface of the anchoring component.

7. The ablation device according to claim 6, characterized in that: The clearance groove at least passes through the distal end surface of the anchoring component.

8. The ablation device according to any one of claims 5 to 7, characterized in that: Along the circumference of the functional component, a support block is provided between two adjacent clearance grooves, and first hinge holes are provided on both side walls of the support block. The first hinge holes are connected to the adjacent clearance grooves, so that any clearance groove is provided with two first hinge holes. The ablation device also includes a rotating shaft, which includes multiple shaft segments. At least one shaft segment is corresponding to one of the giveway grooves, and the two ends of at least one of the shaft segments in its own length direction are respectively arranged in the two first hinge holes connected to the corresponding giveway grooves. The distal end of the flexible strip is arranged in the shaft segment in the corresponding giveway groove, and the length direction of the shaft segment is the rotation axis of the flexible strip.

9. The ablation device according to claim 8, characterized in that The multiple shaft sections of the rotating shaft are integrally formed into a rod-shaped object, and the rotating shaft is passed through the first hinge hole on each of the support blocks along the circumference of the functional component.

10. The ablation device according to claim 8, characterized in that The support block is provided with a mounting groove, and the mounting groove is connected to the two first hinge holes on the support block where the mounting groove is located; Both ends of the shaft segment in its own length direction are arranged in the mounting grooves on the corresponding support blocks.

11. The ablation device according to any one of claims 5 to 7, characterized in that: Along the circumference of the functional component, a support block is provided between two adjacent clearance grooves, and first hinge holes are provided on both side walls of the support block. The first hinge holes are connected to the adjacent clearance grooves, so that any clearance groove is provided with two first hinge holes. A convex shaft is provided at the distal end of the flexible strip, and both ends of the convex shaft in its own length direction are respectively arranged in the two first hinge holes connected to the corresponding give way grooves, and the length direction of the convex shaft is the rotation axis of the flexible strip.

12. The ablation device according to claim 11, characterized in that The convex shaft is integrally formed and arranged at the distal end of the flexible strip; or the convex shaft includes a first sub-shaft and a second sub-shaft, the first sub-shaft and the second sub-shaft are respectively arranged on both sides of the flexible strip along the circumference of the functional component, and the first sub-shaft and the second sub-shaft are respectively arranged in the two first hinge holes connected to the corresponding give way grooves at one end away from the flexible strip along the circumference of the functional component.

13. The ablation device according to claim 1, wherein: The outer diameter of the anchor is less than or equal to the outer diameter of the catheter body.

14. The ablation device according to claim 1, wherein: The discharge structure is configured as a metal coating containing at least gold; or, the discharge structure is configured as a flexible circuit, and the flexible circuit is provided with a discharge electrode.

15. The ablation device according to claim 1, wherein: At least the flexible strip is provided with insulating regions on both sides of the discharge structure, and the length of the insulating region near the distal end of the flexible strip is shorter than the length of the insulating region near the proximal end of the flexible strip.

16. The ablation device according to claim 1, wherein: The ablation device further includes a head end electrode, which is arranged on the distal end surface of the anchoring member.

17. The ablation device according to claim 16, characterized in that The anchor is provided with a mounting hole, the head end electrode is arranged in the mounting hole, and at least the distal end of the head end electrode protrudes from the distal end surface of the anchor.

18. The ablation device according to claim 16, wherein: The ablation device further includes a ring electrode, which is disposed at the distal end of the catheter body; or, the ring electrode is disposed on the sheath.

19. The ablation device according to claim 18, wherein: One of the head-end electrode and the ring electrode is set as a positive electrode, and the other is set as a negative electrode, and the head-end electrode is used to form an electric field between the head-end electrode and the ring electrode.

20. The ablation device according to claim 1, wherein The flexible strips are arranged along the circumference of the catheter body, and the electrode polarity of the discharge structure on one of at least two adjacent flexible strips is opposite to the electrode polarity of the discharge structure on the other flexible strip.

21. The ablation device according to claim 1, wherein The ablation device further includes a balloon, which is disposed in a space enclosed by the plurality of flexible strips and is configured to contact the target tissue after expansion.

22. The ablation device according to claim 1, wherein The ablation device further includes an adjusting member, which is movably disposed through the catheter body and connected to the anchoring member.

23. 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 catheter body having a centerline; a functional component, the functional component being disposed at the distal end of the catheter body; The functional component comprises at least a first state and a second state, and the functional component is at least partially configured to be movable along the axial direction of the catheter body to convert between the first state and the second state; wherein the radial dimension of the functional component in the first form is greater than the radial dimension of the functional component in the second form; an anchor member located at a distal end of the functional component, the anchor member being rotatably connected to the distal end of the functional component, wherein a rotation axis of the distal end of the functional component forms an angle with the center line; At least part of the anchoring member is an insulating structure; A handle is coupled to the catheter body.

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