A paddle-tipped continuously adjustable curved high-density mapping ablation catheter

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a paddle-shaped head end continuous adjustable bending high-density mapping ablation catheter, which comprises a proximal end of a catheter main body connected with a handle assembly, an adjustable bending section connected with a distal end of the catheter main body, and a paddle-shaped electrode assembly connected with a distal end of the adjustable bending section; a first control mechanism is arranged on the handle assembly, a proximal end of a first traction transmission member is connected with the first control mechanism, and a distal end of the first traction transmission member extends to the distal adjustable bending section; the first control mechanism drives the first traction transmission member to generate axial displacement, so that the distal adjustable bending section is switched between an initial state and a bending state; a second control mechanism is arranged on the handle assembly, a proximal end of a second traction transmission member is connected with the second control mechanism, and a distal end of the second traction transmission member extends to the paddle-shaped electrode assembly; the second control mechanism drives the second traction transmission member to generate axial displacement, so that the paddle-shaped electrode assembly changes in shape; the first control mechanism and the second control mechanism are independently arranged and respectively control the distal adjustable bending section and the paddle-shaped electrode assembly to act.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip. Background Technology

[0002] With the development of cardiac electrophysiological interventional technology, high-density mapping catheters have been widely used for the identification and localization of abnormal electrical activity areas within the cardiac chambers. However, existing paddle-shaped catheters, after integrating ablation functions, often suffer from insufficient tip flexibility and limited deformation adaptability. Summary of the Invention

[0003] To address the aforementioned problems in the prior art, this invention provides a high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip.

[0004] This application provides a high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip, including a handle assembly, a catheter body, an adjustable section, a paddle-shaped electrode assembly, a first control mechanism, a second control mechanism, a first traction transmission component, and a second traction transmission component. The proximal end of the catheter body is connected to the handle assembly, the bending section is connected to the distal end of the catheter body, and the paddle electrode assembly is connected to the distal end of the bending section. The first control mechanism is disposed on the handle assembly. The proximal end of the first traction transmission member is connected to the first control mechanism, and the distal end extends to the distal bending section. The first control mechanism drives the first traction transmission member to generate axial displacement, so that the distal bending section switches between the initial state and the bending state. The second control mechanism is disposed on the handle assembly. The proximal end of the second traction transmission member is connected to the second control mechanism, and the distal end extends to the paddle-shaped electrode assembly. The second control mechanism drives the second traction transmission member to generate axial displacement, causing the paddle-shaped electrode assembly to change shape. The first control mechanism and the second control mechanism are set independently to control the action of the remote bending section and the paddle electrode assembly, respectively.

[0005] Optionally, the handle assembly includes a first housing and a second housing that are interlocked with each other. The first control mechanism is disposed within the first housing, and the second control mechanism is disposed within the second housing. A first adjustment operation member corresponding to the first control mechanism is disposed on the outer surface of the first housing, and a second adjustment operation member corresponding to the second control mechanism is disposed on the outer surface of the second housing. The first adjustment operation member is drive-connected to the first control mechanism, and the second adjustment operation member is drive-connected to the second control mechanism. The proximal ends of the first traction transmission member and the second traction transmission member are respectively connected to the corresponding first control mechanism and the second control mechanism.

[0006] Optionally, the first control mechanism includes a winding member rotatably disposed within the first housing, the first adjustment operation member being coaxially or drive-connected to the winding member, the proximal end of the first traction transmission member being fixed to the winding member, and the first adjustment operation member driving the winding member to rotate when rotating, thereby driving the first traction transmission member to move axially.

[0007] Optionally, the second control mechanism includes a connecting seat that is movable along the length of the second housing, the second adjustment operation member is disposed on the outer surface of the second housing and is fixedly connected or drivenly connected to the connecting seat, the proximal end of the second traction transmission member is fixed to the connecting seat, and when the second adjustment operation member moves along the proximal end or the distal end, it drives the connecting seat to move synchronously, so as to drive the second traction transmission member to move axially.

[0008] Optionally, the second housing is provided with a guide structure that cooperates with the connecting seat. The guide structure includes a guide rail and a guide groove structure that cooperate. The connecting seat moves linearly back and forth along the length direction of the second housing under the limitation of the guide structure.

[0009] Optionally, the handle assembly includes a position holding component, which is respectively disposed between the first control mechanism and the first housing and / or between the second control mechanism and the second housing. The position holding component includes a damping element or a locking element. The damping element abuts against the corresponding control mechanism, or the locking element engages with the corresponding control mechanism to maintain the current position of the corresponding control mechanism.

[0010] Optionally, the catheter body and / or the bending section is a multi-lumen tube structure, which includes a central guide cavity located at the center, a first traction cavity and a second traction cavity disposed on both sides of the central guide cavity, and an eccentrically disposed guide cavity, wherein the first traction transmission component and the second traction transmission component are respectively inserted into the corresponding lumens.

[0011] Optionally, the first traction transmission component includes two bending traction components, which are respectively disposed in the first traction chamber and the second traction chamber. The distal ends of the two bending traction components are respectively connected to the opposite sides of the bending section. The first control mechanism drives one or two of the bending traction components to generate axial displacement, so as to drive the bending section to bend to the corresponding side.

[0012] Optionally, the paddle-shaped electrode assembly includes an elastic support frame, a carrier sleeve covering the outside of the elastic support frame, and a plurality of mapping and ablation electrodes disposed on the outer surface of the carrier sleeve. The proximal end of the elastic support frame is connected to the distal end of the bending section, the carrier sleeve is sleeved and fixed to the outside of the elastic support frame, and the plurality of mapping and ablation electrodes are spaced apart along the outer surface of the carrier sleeve.

[0013] Optionally, the elastic support frame includes two curved support arms arranged opposite each other, a distal connection portion connecting the distal ends of the two curved support arms, and a proximal mounting portion connecting the proximal ends of the two curved support arms. The proximal mounting portion is fixedly connected to the distal end of the bending section. The two curved support arms are located on both sides of the paddle-shaped electrode assembly and together with the distal connection portion form a deformable paddle-shaped support profile.

[0014] Optionally, the second traction transmission component is a second traction wire. The second traction wire passes through the bending section and is connected to the distal connection part. The second control mechanism drives the second traction wire to move axially, thereby causing the distal connection part to move relative to the proximal mounting part, so that the elastic support frame switches between a contracted state and an extended state. When the elastic support frame is in the extended state, it can bend and deform under the action of external force and / or the continued traction of the second traction wire.

[0015] Optionally, the carrier sleeve is a multi-cavity sleeve structure, which includes a skeleton receiving cavity and a wire receiving cavity. The elastic support skeleton is disposed in the skeleton receiving cavity, and the electrode wire of the mapping ablation electrode passes through the wire receiving cavity. The carrier sleeve is also provided with a fluid channel and / or a sensor wire channel.

[0016] Optionally, a plurality of the calibration ablation electrodes are arranged in an array along the length and circumferential direction of the paddle-shaped electrode assembly. The paddle-shaped electrode assembly is further provided with at least one of a temperature detection element, a contact force detection element, and an impedance detection element. The temperature detection element, contact force detection element, or impedance detection element is connected to a wire in the handle assembly through a sensor wire channel.

[0017] The advantages of this invention compared to the prior art are as follows: The high-density mapping and ablation catheter with a continuously adjustable paddle tip provided in this application, by setting up a handle assembly, a catheter body, an adjustment section, and a paddle electrode assembly, and by using independent first and second control mechanisms to drive the first and second traction transmission components respectively, enables the distal adjustment section to achieve overall bending adjustment, and the paddle electrode assembly to achieve tip shape change. Thus, the catheter has both overall guiding capability and local continuous contact adjustment capability. At the same time, this structure helps to improve the problems of insufficient tip flexibility and limited deformation adaptability of existing paddle catheters with integrated ablation function, improves the catheter's contact adaptability and contact stability to complex cardiac chamber walls, and thus enhances the operational flexibility and effectiveness in the mapping and ablation process. Attached Figure Description

[0018] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 To illustrate this application, a three-dimensional schematic diagram of a high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip is provided.

[0020] Figure 2 For the purposes of this application, a three-dimensional schematic diagram of a paddle-shaped electrode assembly is provided.

[0021] Figure 3 To illustrate the present application, a schematic diagram of the electrode polarity distribution of a paddle-shaped electrode assembly is provided.

[0022] Figure 4 For the purposes of this application, a schematic diagram of an elastic support frame is provided.

[0023] Figure 5 For the purposes of this application, a schematic diagram of a carrier sleeve is provided.

[0024] Figure 6 To illustrate this application, a cross-sectional schematic diagram of a carrier sleeve is provided.

[0025] Figure 7 For the purposes of this application, a cross-sectional schematic diagram of a catheter body is provided.

[0026] Figure 8 To illustrate this application, another perspective three-dimensional schematic diagram of a high-density mapping ablation catheter with a continuously adjustable paddle-shaped tip is provided.

[0027] Figure 9 For the purposes of this application, a first-view stereoscopic diagram of a handle assembly is provided.

[0028] Figure 10 To illustrate this application, a second-view stereoscopic diagram of a handle assembly is provided.

[0029] Figure 11 For the purposes of this application, a cross-sectional schematic diagram of a handle assembly is provided.

[0030] Figure 12 To illustrate this application, a top view schematic diagram of a high-density mapping ablation catheter with a continuously adjustable paddle-shaped tip is provided.

[0031] Figure 13 for Figure 12 A sectional view along section AA.

[0032] Figure 14 To illustrate the initial state of a bending section according to this application, a schematic diagram is provided.

[0033] Figure 15 To illustrate the bending state of a bending section according to this application, a schematic diagram is provided.

[0034] Figure 16 To illustrate the initial state of a paddle-shaped electrode assembly according to this application, a schematic diagram is provided.

[0035] Figure 17 To illustrate this application, a schematic diagram of a paddle-shaped electrode assembly in a bent state is provided.

[0036] In the figure: 100, handle assembly; 110, first housing; 120, second housing; 130, first adjustment operating component; 140, second adjustment operating component; 151, first rubber damping pad; 152, second rubber damping pad; 160, guide structure; 171, winding component; 181, connecting seat; 200, conduit body; 210, central guide cavity; 220, first traction cavity; 230, second traction cavity; 240, wire cavity; 300, bending section; 310, first traction transmission component; 311, bending traction component; 400, paddle electrode assembly; 410, elastic support frame; 411, bending support arm; 412, distal connection part; 413, proximal mounting part; 420, carrier sleeve; 421, frame receiving cavity; 422, wire receiving cavity; 430, mapping ablation electrode; 500, second traction transmission component. Detailed Implementation

[0037] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present invention can be modified or changed according to different viewpoints and application systems without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0038] The present invention will now be described in detail with reference to the accompanying drawings, so that those skilled in the art can readily implement it. The present invention can be embodied in many different forms and is not limited to the embodiments described herein.

[0039] In the representation of this invention, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics represented in connection with that embodiment or example, which are included in at least one embodiment or example of the invention. Furthermore, the specific features, structures, materials, or characteristics represented may be combined in any suitable manner in one or more embodiments or examples. Moreover, those skilled in the art can combine and integrate different embodiments or examples represented in this invention, as well as features of different embodiments or examples, without contradiction.

[0040] Furthermore, the terms "first" and "second" are used for illustrative purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the representation of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0041] To clearly illustrate the present invention, components unrelated to the description are omitted, and the same or similar constituent elements throughout the specification are given the same reference numerals.

[0042] Throughout the specification, when it is said that a device is "fixed" to another device, this includes not only "direct fixation" but also "indirect fixation" by placing other components in between. Furthermore, when it is said that a device "includes" a certain component, unless otherwise stated otherwise, this does not exclude other components, but rather implies that other components may be included.

[0043] When we say that a device is "above" another device, this can mean that it is directly above the other device, or it can mean that other devices are present in between. Conversely, when we say that a device is "directly" "above" another device, there are no other devices present in between.

[0044] Although not explicitly defined, all terms, including technical and scientific terms used herein, shall have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries shall be further interpreted as having a meaning consistent with relevant technical literature and the content of this present instruction, and shall not be over-interpreted as having an ideal or overly formulaic meaning unless otherwise defined.

[0045] like Figures 1 to 17 As shown, this embodiment provides a high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip, including a handle assembly 100, a catheter body 200, an adjustable section 300, and a paddle-shaped electrode assembly 400 connected to the distal end of the adjustable section 300.

[0046] The handle assembly 100 is provided with a first control mechanism and a second control mechanism that are independent of each other. The first control mechanism is connected to the bending section 300 through the first traction transmission member 310, and the second control mechanism is connected to the paddle electrode assembly 400 through the second traction transmission member 500, thereby forming a dual control structure that controls the bending section 300 and the paddle electrode assembly 400 respectively.

[0047] The catheter body 200 is a slender, flexible tube suitable for intraluminal delivery. Its proximal end is connected to the handle assembly 100, and its distal end is connected to the bending section 300. The interior of the catheter body 200 can be used to house traction components, leads, sensor leads, fluid channels, and other functional components, thereby meeting the integrated needs of distal signal acquisition, energy transmission, morphological adjustment, and auxiliary cooling. The material, outer diameter, length, and interlayer combination of the catheter body 200 can be configured according to different applicable sites, as long as it meets the requirements of cardiac electrophysiology interventional devices in terms of delivery, flexibility, flexural strength, and torsional resistance.

[0048] In a preferred embodiment, the catheter body 200 adopts a segmented configuration, including a proximal support section, a middle transition section, and a distal compliant section. The proximal support section improves axial support performance and push response, the middle transition section improves the overall rigid-flexible transition, and the distal compliant section helps reduce mechanical stimulation of tissues during distal movement within the lumen. To enhance the transmission capability from proximal to distal manipulation, a reinforcing layer may also be provided in the wall of the catheter body 200. The reinforcing layer can be one or more of a metal braided layer, a metal spring layer, and a polymer reinforcing fiber layer. With the aid of the reinforcing layer, the catheter body 200 can possess better torque response performance and overall support performance.

[0049] Further reference Figures 8 to 13 The handle assembly 100 includes a first housing 110 and a second housing 120. A first control mechanism is disposed within the first housing 110, and a second control mechanism is disposed within the second housing 120. A first adjustment operating element 130 corresponding to the first control mechanism is disposed on the outer surface of the first housing 110, and a second adjustment operating element 140 corresponding to the second control mechanism is disposed on the outer surface of the second housing 120. The two control mechanisms are arranged independently, allowing the operator to adjust the distal end orientation of the guide tube and the contact shape of the paddle head end separately.

[0050] The first adjustment operating component 130 can be a knob, dial, or other rotary operating member. Correspondingly, the first control mechanism includes a winding component 171 rotatably disposed within the first housing 110. The first adjustment operating component 130 is coaxially or drive-connected to the winding component 171, and the proximal end of the first traction transmission component 310 is fixed to the winding component 171. When the first adjustment operating component 130 is rotated, the winding component 171 rotates synchronously, thereby driving the first traction transmission component 310 to move axially to change the bending state of the bending section 300.

[0051] The second adjustment operating member 140 can be a sliding push button, slider, push rod, or other linear operating component. Correspondingly, the second control mechanism includes a connecting seat 181 that is movable along the length of the second housing 120. The second adjustment operating member 140 is fixedly connected to or driven by the connecting seat 181, and the proximal end of the second traction transmission member 500 is fixed to the connecting seat 181. When the second adjustment operating member 140 is pushed or pulled back, the connecting seat 181 moves synchronously along the axial direction, thereby causing the second traction transmission member 500 to generate axial displacement, so as to change the shape of the paddle-shaped electrode assembly 400.

[0052] To ensure the smooth movement of the second control mechanism, a guide structure 160 may be provided inside the second housing 120. The guide structure 160 may be a combination of a guide rail and a guide groove, a combination of a guide post and a guide hole, or other structures capable of achieving linear limiting guidance. The connecting seat 181 moves along a predetermined direction under the constraint of the guide structure 160, which helps to improve the transmission accuracy and repeatability of the second control mechanism.

[0053] A position holding component may also be provided within the handle assembly 100. The position holding component can be located between the first control mechanism and the first housing 110, or between the second control mechanism and the second housing 120, and can act on both control mechanisms simultaneously. The position holding component may include a damping element or a locking element. The damping element may be a rubber damping pad, an elastic friction plate, or other friction damping structure, and the locking element may be a mechanical locking structure, a ratchet engagement structure, or a spring self-locking structure. The position holding component can maintain the adjusted positions of the first adjustment operating member 130 and the second adjustment operating member 140, thereby reducing unintended displacement caused by elastic recovery at the distal end. In this embodiment, a first rubber damping pad is provided between the first control mechanism and the first housing 110, and a second rubber damping pad is provided between the second control mechanism and the second housing 120.

[0054] In one specific example of this application, the catheter body 200 and / or the bending section 300 can adopt a multi-lumen tube structure. This multi-lumen tube structure includes a central guide cavity 210, a first traction cavity 220, a second traction cavity 230, and a guide wire cavity 240. The central guide cavity 210 is located in the central region and serves as a central guide channel; two first traction cavities 220 are respectively located on both sides of the central guide cavity 210 for the passage of two bending traction components; the second traction cavity 230, used for the passage of the second traction wire, is located between the two first traction cavities 220; and the guide wire cavity 240 is eccentrically positioned for the passage of electrode wires, sensor wires, and other functional wires. The multi-lumen structure can be a four-lumen form, or it can be designed as a three-lumen, five-lumen, or more-lumen form depending on the degree of functional integration.

[0055] like Figure 13 As shown, the first traction transmission component 310 includes two bending traction components 311, which are respectively disposed in the first traction cavity 220 and the second traction cavity 230, with their distal ends connected to opposite sides of the bending section 300. By means of the relative displacement of the two bending traction components 311, the bending section 300 can switch between an initial state and a bent state. The bending section 300 can be a unidirectional bending structure, a bidirectional bending structure, or, as needed, a multi-planar bending structure to adapt to the spatial guidance requirements of different anatomical locations.

[0056] The paddle-shaped electrode assembly 400 is located at the far end of the bending section 300 and is the core component for achieving high-density mapping and ablation integration and continuous contact adjustment in this application. The paddle-shaped electrode assembly 400 includes an elastic support frame 410, a carrier sleeve 420 covering the outside of the elastic support frame 410, and multiple mapping and ablation electrodes 430 disposed on the outer surface of the carrier sleeve 420.

[0057] Among them, the elastic support skeleton 410 is used to form the basic outline of the paddle-shaped head end and provide elastic recovery capability; the carrier sleeve 420 is used to carry the electrode, the isolation skeleton and the wire, and form the outer surface that contacts the tissue; multiple mapping ablation electrodes 430 are used to complete local electrical signal acquisition and ablation energy output.

[0058] The proximal end of the elastic support frame 410 is connected to the distal end of the bending section 300. The carrier sleeve 420 is fitted and fixed to the outside of the elastic support frame 410, and multiple mapping and ablation electrodes 430 are arranged at intervals along the outer surface of the carrier sleeve 420. With this configuration, the paddle electrode assembly 400 can provide a large local coverage area and a high electrode arrangement density while maintaining a certain degree of conformity and flexibility.

[0059] In this embodiment, the elastic support frame 410 includes two opposing curved support arms 411, a distal connecting portion 412 connecting the distal ends of the two curved support arms 411, and a proximal mounting portion 413 connecting the proximal ends of the two curved support arms 411. The proximal mounting portion 413 is fixedly connected to the distal end of the bending section 300. The two curved support arms 411 are located on both sides of the paddle-shaped electrode assembly 400 and together with the distal connecting portion 412 form a deformable paddle-shaped support profile. This support profile can form a large planar working area, or it can be transformed into a contracted or relatively straightened state under axial traction to meet the switching requirements between the conveying and working states.

[0060] The elastic support skeleton 410 is preferably made of shape memory alloy material, such as nickel-titanium alloy; other medical metal materials with superelasticity and shape recovery capabilities can also be used. Its structural form can be round wire, flat wire, sheet, or plate. It can be formed by connecting two, three, or four skeleton components, or it can be a one-piece cut structure. By changing the skeleton material, cross-sectional dimensions, cross-sectional shape, pre-fabricated bending profile, and connection method, the unfolding force, recovery force, bending compliance, and maximum deformation range can be adjusted.

[0061] The second traction transmission component 500 is preferably a second traction wire. The second traction wire passes through the bending section 300 and is connected to the distal connection portion 412. When the second control mechanism drives the second traction wire to move axially, it can drive the distal connection portion 412 to move relative to the proximal mounting portion 413, thereby switching the elastic support frame 410 between a retracted state and an extended state.

[0062] More specifically, when the second traction wire is in an axial position, the elastic support frame 410 can be in a relatively straight or folded state; after the second traction wire moves in a predetermined direction, the relative position between the distal connection part 412 and the proximal mounting part 413 changes, and the elastic support frame 410 gradually forms an unfolded paddle-shaped profile.

[0063] In the unfolded state, the elastic support frame 410 can also bend and deform under the external contact reaction force and / or the continued traction of the second traction wire, thereby allowing the paddle-shaped electrode assembly 400 to further adjust its contact curvature on the unfolded basis. In other words, the paddle-shaped electrode assembly 400 not only has a simple unfolding function, but also has the ability to continuously bend in the unfolded state to adapt to the contact needs of different curved surface structures.

[0064] The carrier sleeve 420 preferably adopts a thin-walled polymer multi-cavity sleeve structure. Taking a typical configuration as an example, the carrier sleeve 420 includes a skeleton receiving cavity 421 and a wire receiving cavity 422. The elastic support skeleton 410 is disposed in the skeleton receiving cavity 421, and the electrode wire of the mapping ablation electrode 430 passes through the wire receiving cavity 422. According to functional expansion requirements, the carrier sleeve 420 can also be provided with a fluid channel and a sensor wire channel. The fluid channel can be used to transport cooling fluid, and the sensor wire channel can be used to arrange the wires of temperature detection elements, contact force detection elements, impedance detection elements, etc. Therefore, the carrier sleeve 420 can be a dual-cavity, triple-cavity, or more-cavity structure.

[0065] Multiple mapping and ablation electrodes 430 are arranged in an array along the length and circumference of the paddle-shaped electrode assembly 400. The electrodes can be ring-shaped electrodes, sheet electrodes, segment electrodes, or other conductive structures suitable for placement on the outer surface of the paddle. The electrodes can be partially embedded in the surface of the carrier sleeve 420 or attached to the surface of the carrier sleeve 420.

[0066] In some embodiments, the paddle-shaped electrode assembly 400 can form four, six, or eight lateral electrode regions distributed along the width direction, with multiple electrodes arranged along the length direction in each region. To accommodate both mapping and ablation requirements, adjacent electrodes can be arranged in a predetermined polarity manner; for example, adjacent electrodes within the same region have opposite polarities, while corresponding electrodes in adjacent regions have the same polarity. The number, size, spacing, and arrangement density of electrodes can be adjusted according to different application scenarios.

[0067] In addition to the mapping and ablation electrode 430, the paddle electrode assembly 400 may also integrate at least one of a temperature sensing element, a contact force sensing element, and an impedance sensing element. The temperature sensing element can be used to detect temperature changes near the electrode, the contact force sensing element can be used to reflect the contact state between the paddle electrode assembly 400 and the tissue surface, and the impedance sensing element can be used to monitor the impedance characteristics of the contact interface. These sensing elements can be connected to external devices via independent wires, or they can share part of the transmission path with an existing wire system, as long as they can perform the corresponding signal transmission and detection functions.

[0068] In this embodiment, the catheter exhibits the following structural fit relationship in use: When the second control mechanism is in the state of keeping the second traction wire pushed forward or released, the paddle electrode assembly 400 can be in a retracted state or a relatively straightened state to form a smaller profile. When the second control mechanism drives the second traction wire to move in the opposite direction, the elastic support frame 410 gradually forms an unfolded outline. When the paddle-shaped electrode assembly 400 approaches or contacts the target contact surface, the second traction wire can continue to participate in the adjustment, so that the unfolded paddle-shaped electrode assembly 400 forms a close-fitting shape with different degrees of curvature.

[0069] Correspondingly, the first control mechanism can independently change the bending direction and degree of the bending section 300, thereby adjusting the overall orientation of the paddle-shaped electrode assembly 400. By coordinating the directional adjustment of the bending section 300 with the local morphological adjustment of the paddle-shaped electrode assembly 400, the catheter can form a more stable contact state in complex intraluminal environments.

[0070] From the perspective of the device's working state, the catheter of this application can switch between at least the following states: first, a constricted or relatively straight state for easy delivery; second, an unfolded state that forms a planar working profile; and third, a curved and close-fitting state that forms a higher degree of fit based on the unfolded state. These state transitions are all driven by the dual independent control mechanisms in the handle assembly 100, and the corresponding adjustment results are maintained by the position holding assembly.

[0071] It should be noted that in this application, "mapping ablation electrode," "temperature detection element," "contact force detection element," "impedance detection element," and "fluid channel" are all functional overarching concepts, and their subordinate implementations can exist in various forms. For example, the mapping ablation electrode 430 can be used for radiofrequency ablation, pulsed electric field ablation, or other forms of electrophysiological intervention energy; the temperature detection element can be a thermocouple, thermistor, or fiber optic temperature sensor; the contact force detection element can be a strain gauge, fiber optic, or capacitive sensing structure; the impedance detection element can be an independent detection electrode or a combination of the mapping ablation electrode 430; and the fluid channel can be a single-channel, dual-channel, or circulating structure. These different implementations do not affect the core technical concept of this application regarding dual independent control, continuously adjustable paddle-shaped bending, and high-density mapping ablation integration.

[0072] It should also be noted that although the first control mechanism is preferably a rotary drive structure and the second control mechanism is preferably a linear push structure in this embodiment, it is not limited to these. Any mechanism capable of driving the first traction transmission member 310 and the second traction transmission member 500 to generate axial displacement and achieving independent control of the bending section 300 and the paddle-shaped electrode assembly 400 can be used. For example, the first control mechanism can also be a sliding cable type, a rack and pinion type, or other axial drive structure; the second control mechanism can also be a knob winding type, a lever push type, or other drive forms.

[0073] Similarly, although the elastic support frame 410 in this embodiment preferably includes two curved support arms 411, a distal connecting portion 412, and a proximal mounting portion 413, in other embodiments, a multi-support arm structure, a multi-connection point structure, or an integrated paddle-shaped frame structure may also be used. Any structure that can form a retractable, deployable, and further bendable paddle-shaped support profile in the deployed state is suitable. It is worth noting that a binding tube is fitted at the connection between the proximal mounting portion 413 and the bending section 300 to increase the stability of the connection.

[0074] With the above structural configuration, the catheter of this application integrates distal direction adjustment, paddle-shaped local morphology adjustment and high-density mapping and ablation functions into the same device, which is beneficial to improve the device's adaptability to complex anatomical sites and local contact stability, while reducing the risk of positioning deviation caused by switching between different functional devices.

[0075] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the appended claims.

Claims

1. A high-density mapping and ablation catheter with a continuously adjustable, paddle-shaped tip, characterized in that, It includes a handle assembly, a catheter body, a bending section, a paddle electrode assembly, a first control mechanism, a second control mechanism, a first traction transmission component, and a second traction transmission component; The proximal end of the catheter body is connected to the handle assembly, the bending section is connected to the distal end of the catheter body, and the paddle electrode assembly is connected to the distal end of the bending section. The first control mechanism is disposed on the handle assembly. The proximal end of the first traction transmission member is connected to the first control mechanism, and the distal end extends to the distal bending section. The first control mechanism drives the first traction transmission member to generate axial displacement, so that the distal bending section switches between the initial state and the bending state. The second control mechanism is disposed on the handle assembly. The proximal end of the second traction transmission member is connected to the second control mechanism, and the distal end extends to the paddle-shaped electrode assembly. The second control mechanism drives the second traction transmission member to generate axial displacement, causing the paddle-shaped electrode assembly to change shape. The first control mechanism and the second control mechanism are set independently to control the action of the remote bending section and the paddle electrode assembly, respectively.

2. The high-density mapping and ablation catheter with continuously adjustable paddle-shaped tip according to claim 1, characterized in that, The handle assembly includes a first housing and a second housing that are interlocked. The first control mechanism is disposed within the first housing, and the second control mechanism is disposed within the second housing. A first adjustment operation member corresponding to the first control mechanism is disposed on the outer surface of the first housing, and a second adjustment operation member corresponding to the second control mechanism is disposed on the outer surface of the second housing. The first adjustment operation member is drive-connected to the first control mechanism, and the second adjustment operation member is drive-connected to the second control mechanism. The proximal ends of the first traction transmission member and the second traction transmission member are respectively connected to the corresponding first control mechanism and the second control mechanism.

3. The high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip according to claim 2, characterized in that, The first control mechanism includes a winding member rotatably disposed within a first housing. The first adjustment operation member is coaxially or drive-connected to the winding member. The proximal end of the first traction transmission member is fixed to the winding member. When the first adjustment operation member rotates, it drives the winding member to rotate, thereby causing the first traction transmission member to move axially.

4. The high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip according to claim 2, characterized in that, The second control mechanism includes a connecting seat that is movable along the length of the second housing. The second adjustment operation member is disposed on the outer surface of the second housing and is fixedly or pulsally connected to the connecting seat. The proximal end of the second traction transmission member is fixed to the connecting seat. When the second adjustment operation member moves along the proximal end or the distal end, it drives the connecting seat to move synchronously, thereby driving the second traction transmission member to move axially.

5. The high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip according to claim 4, characterized in that, The second housing is provided with a guide structure that cooperates with the connecting seat. The guide structure includes a guide rail and a guide groove structure that cooperate. The connecting seat moves linearly back and forth along the length direction of the second housing under the limitation of the guide structure.

6. The high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip according to claim 2, characterized in that, The handle assembly includes a position holding component, which is respectively disposed between the first control mechanism and the first housing and / or between the second control mechanism and the second housing. The position holding component includes a damping element or a locking element. The damping element abuts against the corresponding control mechanism, or the locking element engages with the corresponding control mechanism to maintain the current position of the corresponding control mechanism.

7. The high-density mapping and ablation catheter with continuously adjustable paddle-shaped tip according to claim 1, characterized in that, The catheter body and / or the bending section are multi-lumen tube structures. The multi-lumen tube structure includes a central guide cavity located at the center, a first traction cavity and a second traction cavity located on both sides of the central guide cavity, and an eccentrically arranged wire cavity. The first traction transmission component and the second traction transmission component are respectively inserted into the corresponding lumens.

8. The high-density mapping and ablation catheter with continuously adjustable paddle-shaped tip according to claim 7, characterized in that, The first traction transmission component includes two bending traction components, which are respectively disposed in the first traction chamber and the second traction chamber. The distal ends of the two bending traction components are respectively connected to the opposite sides of the bending section. The first control mechanism drives one or two bending traction components to generate axial displacement, so as to drive the bending section to bend to the corresponding side.

9. The high-density mapping and ablation catheter with continuously adjustable paddle-shaped tip according to claim 1, characterized in that, The paddle-shaped electrode assembly includes an elastic support frame, a carrier sleeve covering the outside of the elastic support frame, and multiple mapping and ablation electrodes disposed on the outer surface of the carrier sleeve. The proximal end of the elastic support frame is connected to the distal end of the bending section. The carrier sleeve is sleeved and fixed to the outside of the elastic support frame. The multiple mapping and ablation electrodes are spaced apart along the outer surface of the carrier sleeve.

10. The high-density mapping and ablation catheter with continuously adjustable paddle-shaped tip according to claim 9, characterized in that, The elastic support frame includes two curved support arms arranged opposite each other, a distal connection portion connecting the far ends of the two curved support arms, and a proximal mounting portion connecting the near ends of the two curved support arms. The proximal mounting portion is fixedly connected to the far end of the bending section. The two curved support arms are located on both sides of the paddle-shaped electrode assembly and together with the distal connection portion form a deformable paddle-shaped support profile.

11. The high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip according to claim 10, characterized in that, The second traction transmission component is a second traction wire. The second traction wire passes through the bending section and is connected to the distal connection part. The second control mechanism drives the second traction wire to move axially, so as to move the distal connection part relative to the proximal mounting part, so that the elastic support frame switches between a contracted state and an extended state. When the elastic support frame is in the extended state, it can bend and deform under the action of external force and / or the continued traction of the second traction wire.

12. The high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip according to claim 10, characterized in that, The carrier sleeve is a multi-cavity sleeve structure, which includes a skeleton receiving cavity and a wire receiving cavity. The elastic support skeleton is disposed in the skeleton receiving cavity, and the electrode wire of the calibration ablation electrode passes through the wire receiving cavity. The carrier sleeve is also provided with a fluid channel and / or a sensor wire channel.

13. The high-density mapping and ablation catheter with a continuously adjustable paddle-shaped tip according to claim 1, characterized in that, Multiple ablation electrodes are arranged in a longitudinal and circumferential array along the paddle electrode assembly. The paddle electrode assembly is further provided with at least one of a temperature detection element, a contact force detection element, and an impedance detection element. The temperature detection element, contact force detection element, or impedance detection element is connected to a wire in the handle assembly through a sensor wire channel.

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