Bidirectional control bending catheter

Abstract

The utility model belongs to the technical field of medical apparatus and instruments, disclose a kind of two-way control bending catheter, including pull wire and the bending handle, main body section and adjustable bending section connected in sequence;The bending handle includes shell and coaxial member, the coaxial member is rotatably connected with the shell, and the rotation center of the coaxial member is its own axis;The outer lateral wall of the coaxial member is equipped with arc part, the curvature center of the outer circumferential surface of the arc part does not coincide with the axis of the coaxial member, and the both ends of the arc part are located on reference circle with the axis of the coaxial member as center, and the arc part is located on the outside of the reference circle;The distal end of the pull wire passes through the main body section and is fixedly connected with the adjustable bending section respectively;The proximal end of the pull wire is fixed to the coaxial member;When the coaxial member rotates around its own axis, the pull wire is coiled on the arc part.The utility model can improve the two-way control bending angle of catheter.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a bidirectional controllable bending catheter. Background Technology

[0002] Catheter intervention is a common method for diagnosing and treating arrhythmias. Currently, most mapping and ablation catheters used in clinical practice in China are single-bend catheters, meaning they can only bend to a fixed shape. Single-bend catheters are popular in clinical practice due to their ease of operation and low cost. However, with the advancement of medicine, an increasing number of clinical cases show that single-bend catheters have certain limitations in diagnosing and treating arrhythmias, especially in complex cases. Changing catheters can cause discomfort to patients and easily lead to other complications. Furthermore, with the rapid increase in the number of patients with arrhythmias worldwide, the demand for minimally invasive and low-radiation procedures is becoming increasingly important. Therefore, there is a clinical need for a more functional bidirectional bendable catheter to replace the existing single-bend catheters.

[0003] A bidirectional bendable catheter is a type of catheter that allows for bend control on both sides of the same or different bends within the same catheter. The asymmetry of its bends offers a significant advantage in complex cardiovascular surgeries requiring access to multiple sites for mapping and ablation. Compared to single-bend catheters, bidirectional bendable catheters are easier to approach and straighten, aiding the surgeon's positioning and manipulation. Furthermore, without compromising mapping and ablation effectiveness, bidirectional bendable catheters can reduce the number of catheter changes, shorten procedure time, and potentially decrease the risk of complications.

[0004] Currently, the bending angle range of bidirectional bending control catheters available in domestic and international markets is basically -180° to 180°. This bending angle range has certain limitations in clinical use. For example, in some special locations in the heart chamber that are difficult to reach (near the septum, valve annulus, etc.), a bending angle of 180° cannot meet clinical requirements. Clinically, there is a need for a bidirectional bending control catheter with a larger bending angle. Utility Model Content

[0005] The purpose of this application is to provide a bidirectional bending control conduit that can improve the bidirectional bending angle of the conduit.

[0006] The technical solution provided in this application is as follows:

[0007] A bidirectional bending control conduit includes: a pull wire and a bending control handle, a main body section, and an adjustable bending section connected in sequence;

[0008] The bending control handle includes a housing and a coaxial component. The coaxial component is rotatably connected to the housing, and the rotation center of the coaxial component is its own axis. The outer side wall of the coaxial component is provided with an arc portion. The curvature center of the outer circumference of the arc portion does not coincide with the axis of the coaxial component. The two ends of the arc portion are located on a reference circle with the axis of the coaxial component as the center, and the arc portion is located outside the reference circle.

[0009] The distal end of the pull wire passes through the main body section and is fixedly connected to the adjustable bending section; the proximal end of the pull wire is fixed to the coaxial member; when the coaxial member rotates around its own axis, the pull wire is coiled around the arc portion.

[0010] In some embodiments, the outer periphery of the coaxial member is provided with an arc-shaped groove extending in the circumferential direction, the bottom surface of the arc-shaped groove is located on the reference circle, and the arc portion is disposed in the arc-shaped groove.

[0011] In some embodiments, the arcuate portion does not protrude beyond the outer peripheral surface of the coaxial member, and a step portion is formed between the arcuate portion and the outer peripheral surface of the coaxial member to axially limit the pull wire.

[0012] In some embodiments, the pull wire includes a first pull wire and a second pull wire, the first pull wire and the second pull wire being respectively disposed on both sides of the arc portion;

[0013] The coaxial component is provided with a first pull wire hole and a second pull wire hole on both sides of the arc portion along the circumferential direction; the proximal end of the first pull wire is fixed to the first pull wire hole; the proximal end of the second pull wire is fixed to the second pull wire hole;

[0014] When the coaxial component rotates around its own axis, the first or second pull wire is coiled around the arc portion to achieve axial traction.

[0015] In some embodiments, the arcuate portion has a first arcuate protrusion at one end along the circumferential direction, and a second arcuate protrusion at the other end along the circumferential direction;

[0016] After the first pull wire passes through the first pull wire hole, it wraps around the outer periphery of the first arc-shaped protrusion and then enters the main body section; after the second pull wire passes through the second pull wire hole, it wraps around the outer periphery of the second arc-shaped protrusion and then enters the main body section.

[0017] In some embodiments, the bending control handle further includes a dial, the dial having a first connecting portion in the middle, and the coaxial member having a second connecting portion, the second connecting portion being coaxially connected to the first connecting portion and circumferentially preventing rotation, so as to achieve integral rotation.

[0018] In some embodiments, an electrode assembly is also included, which is disposed in the adjustable bend and the electrodes in the electrode assembly are insulated from each other.

[0019] In some embodiments, the electrode assembly includes a head electrode and a plurality of annular electrodes arranged at intervals along the distal to proximal direction of the adjustable bend.

[0020] It also includes a pressure sensor, which is disposed between any two of the annular electrodes;

[0021] The diameter of the head electrode ranges from 1.5 to 3 mm, and the width ranges from 1 to 4 mm; the diameter of the ring electrode ranges from 1.5 to 3 mm, and the width ranges from 0.5 to 4 mm.

[0022] The distance between the head electrode and the adjacent annular electrode is 1 to 3 mm, the distance between the two annular electrodes on which the pressure sensor is located is 4 to 7 mm, and the distance between the remaining annular electrodes is 1 to 3 mm.

[0023] In some embodiments, the electrode assembly includes a plurality of annular electrodes, one of which is disposed inside the head end of the adjustable bend, and the remaining annular electrodes are spaced apart along the axial direction on the outer side wall of the adjustable bend.

[0024] In some embodiments, the distal end of the adjustable bending section is provided with a mesh-like support structure;

[0025] The electrode assembly includes multiple ring electrodes, which are arranged on the mesh-like support structure to form a mesh-like electrode structure.

[0026] Alternatively, the distal end of the adjustable bending section is provided with a ring-shaped support structure;

[0027] The electrode assembly includes multiple ring electrodes, which are arranged on the ring-shaped support structure to form a ring electrode structure.

[0028] Alternatively, the distal end of the adjustable bending section is provided with a five-claw-shaped support structure;

[0029] The electrode assembly includes multiple ring electrodes, which are arranged on the five-claw-shaped support structure to form a five-claw-shaped electrode structure.

[0030] In some embodiments, the bidirectional bending control catheter undergoes pulsed discharge ablation;

[0031] The electrodes within the electrode group undergo unipolar pulse discharge with the external electrodes; or the electrodes within the electrode group undergo pulse discharge with each other.

[0032] The technical advantage of this application is that an arc portion is provided on the outer side of the coaxial component. The radius of curvature of the arc portion does not coincide with the axis of the coaxial component, and the arc portion protrudes outward relative to the reference circle of the coaxial component. The arc length of the arc portion is greater than the length of the arc segment on the reference circle corresponding to the arc portion. Compared with directly winding the pull wire around the arc of the reference circle, this application winds the pull wire around the arc portion, which can increase the stroke of the pull wire, thereby increasing the bidirectional bending angle of the catheter, making the bidirectional bending angle greater than 180 degrees, or even reaching 270 degrees, to meet the ablation needs of some special or complex sites in clinical practice. Attached Figure Description

[0033] The present application will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0034] Figure 1 This is a schematic diagram of the structure of a bidirectional bending control conduit provided in an embodiment of this application;

[0035] Figure 2 This is a schematic diagram of the internal structure of a bending handle provided in an embodiment of this application;

[0036] Figure 3 This is a cross-sectional schematic diagram of a coaxial member provided in an embodiment of this application;

[0037] Figure 4 This is a schematic diagram of the structure of a coaxial component provided in another embodiment of this application;

[0038] Figure 5 This is a cross-sectional schematic diagram of a coaxial member provided in another embodiment of this application;

[0039] Figure 6 This is a schematic diagram of the coaxial component and dial provided in one embodiment of this application;

[0040] Figure 7 This is a schematic diagram of the external structure of a bending handle provided in one embodiment of this application;

[0041] Figure 8 This is a schematic cross-sectional view of a catheter provided in one embodiment of this application;

[0042] Figure 9 This is a schematic diagram of the electrode distribution at the tip of a catheter provided in one embodiment of this application;

[0043] Figure 10 This is a schematic diagram of the electrode distribution at the tip of the catheter provided in another embodiment of this application;

[0044] Figure 11 This is a schematic diagram of the structure of an electrode assembly provided in an embodiment of this application;

[0045] Figure 12This is a schematic diagram of the structure of an electrode assembly provided in another embodiment of this application;

[0046] Figure 13 This is a schematic diagram of the structure of an electrode assembly provided in another embodiment of this application.

[0047] Explanation of icon numbers:

[0048] 10. First pull line; 20. Second pull line;

[0049] 100. Bending handle; 110. Housing; 120. Coaxial component; 121. Arc groove; 122. First cable hole; 123. Second cable hole; 124. Second connecting part; 130. Arc portion; 131. First arc protrusion; 132. Second arc protrusion; 140. Step portion; 150. Cable divider; 160. Dial; 161. First connecting part;

[0050] 210. Main body section; 220. Adjustable bending section; 201. Outer tube; 202. Inner tube; 203 / 204 / 205 / 206. Channel; 300. Electrode group; 400. Pressure sensor. Detailed Implementation

[0051] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application can also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0052] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the specific implementation methods of this application will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without creative effort.

[0053] To keep the drawings concise, each drawing only schematically shows the parts relevant to this application, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some drawings, only one of the components with the same structure or function is schematically shown, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0054] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0055] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linkage" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; or they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0056] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) are relative rather than absolute when describing the structure and movement of the various components, and are not intended to limit the direction of the product during actual use.

[0057] Furthermore, in the description of this application, ordinal numbers, such as "first" and "second," are used only to distinguish related objects and should not be construed as indicating or implying the relative importance or order between related objects.

[0058] In this application, the terms "proximal" and "distal" refer to the relative orientation, position, and direction of elements or movements relative to each other from the perspective of a physician using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device that is closer to the physician during normal operation, while "distal" generally refers to the end that first enters the patient's body.

[0059] Existing interventional bidirectional bending control catheters generally utilize a first pull wire and a second pull wire for bidirectional bending control. The proximal ends of the first and second pull wires are respectively fixed to the rotating wheel of the bending control handle. The side wall of the rotating wheel has a radially recessed receiving groove that extends circumferentially along the rotating wheel. The rotating wheel also has two through-holes for the pull wires, which are respectively located at the circumferential ends of the receiving groove. The proximal ends of the first and second pull wires are respectively fixed to the rotating wheel, and their distal ends pass through the corresponding pull wire cavities. When the rotating wheel is rotated, the first or second pull wire is coiled in the receiving groove on the side wall of the rotating wheel to pull the first or second pull wire, thereby achieving bending control in different directions.

[0060] In certain difficult-to-reach locations within the heart chambers (such as near the septum or valve annulus), theoretically, a ±90° rotation of the wheel could unidirectionally pull the first or second cable to achieve a bend greater than 180°. However, to allow structural space for cable routing within the bending control handle, the actual maximum rotation angle of the wheel is far less than 90°. This results in insufficient axial displacement of the two cables, limiting the bending range of the bidirectional bending control catheter to less than 180°, making it difficult to meet clinical needs for larger bending angles. Increasing the wheel diameter to increase cable travel would encroach on the handle's internal space, affecting the cable routing layout.

[0061] To address the problem of insufficient bending angle in existing bidirectional bending control guides, the core concept of this application is as follows: An arc portion eccentric to the coaxial component (wheel) is provided on the outer side of the coaxial component. The pull wire is coiled around the arc portion, and the arc length of the arc portion is greater than the length of the corresponding arc segment on the reference circle. This arc segment corresponds to the same chord length as the arc portion. When the coaxial component rotates around its own axis by a certain angle, compared to the pull wire being directly coiled around the aforementioned arc segment, the length of the pull wire coiled on the arc portion is greater, giving the pull wire a larger stroke and thus increasing the bending angle.

[0062] like Figures 1 to 13 As shown, in one or more embodiments, this disclosure provides a bidirectional bending control conduit, including a pull wire and a bending control handle 100, a main body section 210, and an adjustable bending section 220 connected in sequence; the bending control handle 100 includes a housing 110 and a coaxial member 120, the coaxial member 120 being rotatably connected to the housing 110, and the rotation center of the coaxial member 120 being its own axis; the outer side wall of the coaxial member 120 is provided with an arc portion 130, the curvature center of the outer peripheral surface of the arc portion 130 not coinciding with the axis of the coaxial member 120, the two ends of the arc portion 130 being located on a reference circle with the axis of the coaxial member 120 as the center, and the arc portion 130 being located outside the reference circle; the distal end of the pull wire passes through the main body section 210 and is fixedly connected to the adjustable bending section 220 respectively; the proximal end of the pull wire is fixed to the coaxial member 120; when the coaxial member 120 rotates around its own axis, the pull wire is coiled around the arc portion 130.

[0063] Specifically, the bidirectional bending control conduit includes a bending control handle 100, a main body section 210, and an adjustable bending section 220. Both the main body section 210 and the adjustable bending section 220 are conduit sections. The proximal end of the main body section 210 is connected to the bending control handle 100. A pull cable passes through the main body section 210 and the adjustable bending section 220. The distal end of the pull cable is fixed to the adjustable bending section 220, and the proximal end is fixed to the bending control handle 100. By manipulating the bending control handle 100, the stroke of the pull cable is controlled, thereby achieving bending shape and bending angle control of the adjustable bending section 220. For bidirectional bending control, the pull cable includes a first pull cable 10 and a second pull cable 20. The first pull cable 10 is fixed to one side of the adjustable bending section 220, and the second pull cable 20 is fixed to the other side of the adjustable bending section 220 to achieve bidirectional bending control. The pull cable material is generally nickel-titanium alloy or stainless steel alloy.

[0064] The bending control handle 100 includes a housing 110 and a coaxial member 120. The coaxial member 120 is rotatable relative to the housing around its own axis. When the coaxial member 120 is rotated, the pull cable can be wound around the coaxial member 120 to achieve bending control. The outer wall of the coaxial member 120 is provided with an arc portion 130. When the coaxial member 120 rotates clockwise, the first pull cable 10 is wound around the arc portion 130 to achieve bending control in one direction. When the coaxial member 120 rotates counterclockwise, the second pull cable 20 is wound around the arc portion 130 to achieve bending control in the other direction.

[0065] like Figure 3 The diagram shows a cross-sectional view of the coaxial member 120. The outer periphery of the arc portion 130 is an arc segment on circle C1, with the center of circle C1 being O1 and the radius being R1. This means the center of curvature of the arc portion 130 is the center O1. The two endpoints of the arc portion 130 along the circumferential direction are endpoint A and endpoint B, respectively, and the arc length of the arc portion 130 is L1. The center of the reference circle C2 is the axis O of the coaxial member 120, and the radius is R. Endpoints A and B lie on the reference circle C2, and the arc length corresponding to the chord AB on the reference circle C2 is L2. In this embodiment, the curvature center O1 of the arc portion 130 does not coincide with the center O of the reference circle C2. The radius R1 of circle C1 is smaller than the radius R of the reference circle C2, and the arc portion 130 is located outside the reference circle C2. That is, the arc portion 130 protrudes outward relative to the reference circle C2, and the arc length L1 of the arc portion 130 is greater than the arc length L2 of the corresponding arc segment on the reference circle C2. When the coaxial member 120 rotates at a certain angle, compared to the first pull wire 10 or the second pull wire 20 being coiled on the corresponding arc segment (arc segment with arc length L2) of the reference circle C2, in this embodiment, the first pull wire 10 or the second pull wire 20 is coiled on the arc portion 130 with arc length L1. This can increase the stroke of the first pull wire 10 or the second pull wire 20, thereby increasing the bidirectional bending angle, making the bidirectional bending angle greater than 180 degrees, or even increasing the range of the bidirectional bending angle to -270 degrees to 270 degrees, or to a larger angle range.

[0066] In some embodiments, such as Figure 3 As shown, the outer peripheral surface of the coaxial member 120 is located on the reference circle C2. That is, a circular arc portion 130 that is eccentric to the axis of the coaxial member 120 is directly provided in a part of the outer peripheral surface of the coaxial member 120. This not only increases the stroke of the first pull wire 10 and the second pull wire 20, but also does not require an overall increase in the diameter of the coaxial member 120, thus having a smaller impact on the size of the coaxial member 120. This avoids interference between the coaxial member 120 and the inner cavity of the outer shell 110, and leaves a channel for the electrode wires and the brine injection pipe.

[0067] In some embodiments, such as Figure 4 and Figure 5 As shown, the outer periphery of the coaxial member 120 is provided with an arc-shaped groove 121 extending in the circumferential direction. The bottom surface of the arc-shaped groove 121 along the radial direction of the coaxial member 120 is located on the reference circle C2, and the arc portion 130 is disposed in the arc-shaped groove 121.

[0068] When the coaxial member 120 rotates, the first pull wire 10 or the second pull wire 20 is coiled around the coaxial member 120. To ensure that the first pull wire 10 and the second pull wire 20 do not shift axially when coiled around the coaxial member 120, the coaxial member 120 is provided with an arc-shaped groove 121 extending circumferentially. When the coaxial member 120 rotates, the first pull wire 10 or the second pull wire 20 is coiled within the arc-shaped groove 121, so that the first pull wire 10 or the second pull wire 20 is axially limited by the arc-shaped groove 121. The axial direction of the coaxial member 120 is the thickness direction of the coaxial member 120. The bottom surface of the arc-shaped groove 121 along the radial direction of the coaxial member 120 is located on the reference circle C2. It is assumed that the arc length of the bottom surface of the arc-shaped groove 121 along the radial direction is also L2. When the arcuate portion 130 is not provided within the arcuate groove 121, the first pull wire 10 or the second pull wire 20 is directly coiled around the bottom surface of the arcuate groove 121 with an arc length of L2. The arc length L2 of the bottom surface of the arcuate groove 121 is less than the arc length L1 of the arcuate portion 130, thus reducing the stroke of the first pull wire 10 or the second pull wire 20. In this embodiment, by providing an arcuate portion 130 eccentric to the coaxial member 120 within the arcuate groove 121, when the coaxial member 120 rotates, the first pull wire 10 or the second pull wire 20 is coiled around the longer arcuate portion 130, which increases the stroke of the first pull wire 10 and the second pull wire 20, thereby increasing the range of the control angle of the guide tube.

[0069] In some embodiments, such as Figure 4 As shown, the arc portion 130 does not protrude from the outer peripheral surface C3 of the coaxial member 120. The arc portion 130 forms a step portion 140 between itself and the outer peripheral surface C3 of the coaxial member 120 to axially limit the pull wire.

[0070] The curvature center of the outer peripheral surface C3 of the coaxial component 120 is the axis O of the coaxial component 120. The curvature radius of the outer peripheral surface C3 of the coaxial component 120 is greater than the radius of the reference circle C2. The arc portion 130 does not protrude from the outer peripheral surface C3 of the coaxial component 120, which can avoid increasing the size of the coaxial component 120 and thus avoid interference with the inner cavity of the outer shell 110, leaving a channel for the electrode wires and brine injection pipes.

[0071] The arc portion 130 is located inside the outer peripheral surface C3 of the coaxial member 120. The connection between the arc portion 130 and the outer peripheral surface C3 of the coaxial member 120 forms a step portion 140. The step portion 140 can form a rigid retaining wall in the axial direction. When the coaxial member 120 rotates, the first pull wire 10 or the second pull wire 20 is coiled around the arc portion 130 and blocked by the step portion 140, so as to limit the first pull wire 10 and the second pull wire 20 in the axial direction, prevent the first pull wire 10 or the second pull wire 20 from coming out of the arc portion 130 in the axial direction, and improve the safety of use.

[0072] In some embodiments, such as Figure 3 and Figure 5 As shown, the coaxial member 120 is provided with a first pull wire hole 122 and a second pull wire hole 123 on both sides of the arc portion 130 along the circumferential direction; the proximal end of the first pull wire 10 is fixed in the first pull wire hole 122; the proximal end of the second pull wire 20 is fixed in the second pull wire hole 123; when the coaxial member 120 rotates around its own axis, the first pull wire 10 or the second pull wire 20 is coiled around the arc portion 130 to achieve axial traction.

[0073] In this embodiment, the circumferential length of the arc groove 121 is greater than the circumferential length of the arc portion 130. Spaces are reserved within the arc groove 121 on both sides of the arc portion 130 to communicate with the first pull wire hole and the second pull wire hole, so that the first pull wire 10 and the second pull wire 20 can pass through from both sides of the arc portion 130. Pull wire fixing members can also be respectively provided in the first pull wire hole 122 and the second pull wire hole 123. The pull wire fixing members are threadedly connected to the corresponding pull wire holes, and the first pull wire 10 and the second pull wire 20 are fixedly connected to the corresponding pull wire fixing members to fix the proximal end of the pull wire in the corresponding pull wire hole.

[0074] like Figure 2As shown, the bending handle 100 is also provided with a cable diverter 150. The cable diverter 150 is located on the far end of the coaxial member 120. The cable diverter 150 is used to change the extension direction of the first cable 10 and the second cable 20. After the first cable 10 passes through the first cable hole 122, it goes around one end of the arc portion 130 in the circumferential direction, and then leaves the arc portion 130 and enters the cable diverter 150. Similarly, after the second cable 20 passes through the second cable hole 123, it goes around the other end of the arc portion 130 in the circumferential direction, and then leaves the arc portion 130 and enters the cable diverter 150. The first cable 10 and the second cable 20 that pass through the cable diverter 150 enter the main body section 210 and the adjustable bending section 220.

[0075] In some embodiments, such as Figure 3 and Figure 5 As shown, the arc portion 130 has a first arc-shaped protrusion 131 at one end along the circumference and a second arc-shaped protrusion 132 at the other end along the circumference; the first pull wire 10 passes through the first pull wire hole 122, wraps around the outer periphery of the first arc-shaped protrusion 131, and then passes into the main body section 210; the second pull wire 20 passes through the second pull wire hole 123, wraps around the outer periphery of the second arc-shaped protrusion 132, and then passes into the main body section 210.

[0076] The arc-shaped portion 130 has arc-shaped protrusions at both ends along its circumference. The first pull wire 10 and the second pull wire 20 contact the arc-shaped protrusions, respectively, to prevent the arc-shaped portion 130 from transitioning at a 90-degree right angle, thereby preventing the pull wire from bending sharply at the right-angle edge and improving the service life of the pull wire. In addition, the outward protrusion of the arc-shaped protrusions can increase the actual wrap angle between the pull wire and the arc-shaped portion 130, and the coaxial member 120 can further increase the stroke of the pull wire under the same rotation angle.

[0077] In some embodiments, such as Figure 6 As shown, the bending control handle 100 also includes a dial 160, which is coaxially connected to the coaxial member 120. The dial 160 and the coaxial member 120 cannot rotate relative to each other in the circumferential direction. When the operator moves the dial 160, the dial 160 can drive the coaxial member 120 to rotate synchronously.

[0078] A first connecting portion 161 is provided in the middle of the dial 160, and a second connecting portion 124 is provided on the coaxial member 120. The second connecting portion 124 is coaxially connected to the first connecting portion 161 and prevents rotation in the circumferential direction, so as to achieve integral rotation. The first connecting portion 161 and the second connecting portion 124 can both be cylindrical. The first connecting portion 161 and the second connecting portion 124 are nested together in an adaptive manner. One of the first connecting portion 161 and the second connecting portion 124 is provided with a limiting protrusion, and the other is provided with a limiting groove. Through the cooperation of the limiting protrusion and the limiting groove, the circumferential rotation of the dial 160 and the coaxial member 120 is prevented. In other embodiments, the first connecting portion 161 and the second connecting portion 124 can also achieve circumferential rotation prevention through interference fit, fixed connection or other limiting structures.

[0079] The dial 160 drives the coaxial component 120 to rotate. The larger the rotation angle of the dial 160, the larger the rotation angle of the coaxial component 120, and the greater the winding stroke of the first and second pull wires 10 and 20 of the bidirectional bending control around the coaxial component 120. To increase the rotation angle of the dial 160, such as... Figure 7 As shown, in this embodiment, the P position of the bending control handle 100 is designed as a thin gooseneck shape, which is concave inward to increase the movement trajectory of the dial, thereby increasing the bending angle of the dial 160. In this embodiment, the single-sided rotation angle of the dial 160 of the bending control handle 100 can be equal to or greater than 55 degrees.

[0080] Assuming the arc of the circular section is 80°, calculate the limit stroke of the cable using the following formula:

[0081]

[0082] 20-25mm 15-18 40°-45° 8-11mm 25-30mm 18-21 45°-50° 11-13mm 30-40mm 21-27 50°-55° 13-19mm

[0083] Actual testing verified that when the draw length is approximately 11.5 mm, the catheter can achieve a maximum bending angle of 180°; when the draw length exceeds 13 mm, the catheter can achieve a maximum bending angle of 270°. In this embodiment, the rotation angle of the dial 160 can reach 55°. Therefore, the design of this embodiment can achieve a bidirectional bending angle range of -270° to 270°, better meeting clinical bending control needs.

[0084] In some embodiments, such as Figure 1As shown, based on the above embodiment, the bidirectional bending control catheter also includes an electrode assembly 300. The electrode assembly 300 is disposed in the adjustable bending section 220, and the electrodes within the electrode assembly 300 are insulated from each other. The electrode assembly 300 is disposed on the distal end of the catheter (adjustable bending section 220), and the electrode assembly 300 includes one or more electrodes, which can be used for both mapping and ablation. In this embodiment, the electrode design at the distal end of the bidirectional bending control catheter is based on the technology of changing the electric field distribution between the discharge electrodes. The proximal handle adopts the bending control handle of the above embodiment, which can increase the controlled ablation range of the catheter, thereby enabling ablation in some complex or difficult-to-reach areas within the cardiac chamber.

[0085] This embodiment uses a bidirectional controlled-bend catheter for pulsed discharge ablation and radiofrequency ablation. During ablation, the ablation energy can be selected from either pulsed or radiofrequency ablation energy. For pulsed ablation, this embodiment can select either unipolar or bipolar ablation. Unipolar ablation involves pulsed discharge between the distal electrode of the catheter and the dorsal electrode plate attached to the back of the patient, while bipolar ablation involves pulsed discharge between several electrodes at the distal end of the catheter. Radiofrequency ablation involves placing the electrodes against the surface of the target myocardial tissue and then releasing radiofrequency energy to cause coagulative necrosis of the tissue, thereby blocking abnormal electrical conduction pathways or ablating ectopic pacemakers.

[0086] like Figure 8 As shown, the outer tube 201 of the catheter (main body section + adjustable bend section) is generally made of Pebax or nylon. Since pulse ablation generally uses ultra-high instantaneous voltage (usually voltage > 1000V), in order to enhance the overall insulation performance of the catheter (main body section + adjustable bend section), especially to enhance the insulation performance of the catheter unipolar pulse ablation, this embodiment adds a PI inner tube 202 with anti-insulation performance inside the catheter to enhance the insulation performance of the catheter after immersion in water, and also to enhance the support of the main body section 210 of the catheter, making the catheter easier to manipulate.

[0087] In some embodiments, such as Figure 9 As shown, it also includes a pressure sensor 400. The electrode group 300 includes a head electrode and a plurality of annular electrodes arranged sequentially at intervals along the direction from the distal end to the proximal end of the adjustable bending section. The pressure sensor 400 is disposed between any two annular electrodes. The diameter of the head electrode ranges from 1.5 to 3 mm, and the width ranges from 1 to 4 mm. The diameter of the annular electrodes ranges from 1.5 to 3 mm, and the width ranges from 0.5 to 4 mm. The distance between the head electrode and the adjacent annular electrode ranges from 1 to 3 mm. The distance between the two annular electrodes on which the pressure sensor is disposed ranges from 4 to 7 mm. The distance between the remaining annular electrodes ranges from 1 to 3 mm.

[0088] like Figure 9As shown, electrode 1 is the head electrode, and electrodes 2 to 4 are ring electrodes. Electrode 2 is closest to electrode 1, and electrode 4 is farthest from electrode 1. The pressure sensor 400 is located between electrodes 2 and 3, and the pressure sensor 400 needs to be encased in an insulating layer material. It should be noted that... Figure 9 This is just one example of electrode assembly 300. The number of electrodes in electrode assembly 300 can be greater than four to ensure that the electrodes cover a sufficiently long distal area of ​​the catheter, thereby adapting to the needs of ablation lesions of different lengths and sizes and improving the flexibility of clinical applications. However, too many electrodes will increase the complexity of the catheter structure and the difficulty of manufacturing, and may also lead to problems such as wiring congestion and electrical interference. Therefore, the number of electrodes should be set reasonably to achieve a good balance between functionality and manufacturability. The pressure sensor is used to transmit the pressure data between the distal end of the catheter and the target tissue in real time to an external three-dimensional cardiac electrophysiological mapping system, so that the three-dimensional cardiac electrophysiological mapping system can determine the contact status of the distal end of the catheter.

[0089] The width of the head electrode ranges from 1 to 4 mm, ensuring effective transmission of radiofrequency ablation power while avoiding the reduced distal catheter flexibility caused by an excessively large head electrode or the insufficient ablation efficiency caused by an excessively small head electrode. The width of each ring electrode ranges from 0.5 to 4 mm, allowing the ring electrodes to form uniform and continuous mapping and ablation effects without reducing the resolution between ring electrodes due to excessive width. The electrode diameter is limited to 1.5 to 3 mm, ensuring sufficient electrode contact area while maintaining the overall minimally invasive characteristics of the catheter. The spacing between electrodes without pressure sensors ranges from 1 to 3 mm, ensuring good spatial resolution when multiple electrodes are working simultaneously while avoiding short circuits or overheating caused by electrodes being too close together, thus balancing safety and effectiveness. The spacing between electrodes with pressure sensors ranges from 4 to 7 mm to provide sufficient space for installing the pressure sensors.

[0090] Since pulse ablation typically uses ultra-high instantaneous voltage (usually >1000V), the insulation performance of the electrode wires is critical. Therefore, the electrode wires in this embodiment are generally multi-layered PI insulating wires. Multiple electrode wires can be converged into a single channel 203, 204, 205, or 206, or they can be distributed in different channels. Specifically, for bipolar ablation, the positive electrode wire for pulse ablation can be placed in channel 203, and the negative electrode wire can be placed in channel 204, directly isolating them. This significantly enhances the insulation performance between them, ensuring the reliability of bipolar discharge. Correspondingly, the positive and negative electrode wires can also be placed in channels 205 and 206 respectively, with the same insulation effect. Besides carrying electrode wires, these channels can also carry guy wires or be used as brine injection pipelines, etc.

[0091] In some embodiments, the electrode assembly 300 includes a plurality of annular electrodes, one annular electrode being disposed inside the head end of the adjustable bend 220, wherein the head end of the adjustable bend 220 refers to the distal end of the adjustable bend 220, and the remaining annular electrodes are axially spaced on the outer sidewall of the adjustable bend 220.

[0092] like Figure 10 The diagram shows a focal ablation catheter designed for precise ablation at the target site. Its bidirectional, large-angle bending flexibility effectively achieves this function. Electrodes 1 to 4 are all annular electrodes. Electrode 1 is positioned inside the tip of the adjustable bend section. Electrodes 2 to 4 are positioned outside the adjustable bend section 220, with a certain distance between them and electrode 1 near the proximal end of the adjustable bend section 220. Insulating material is placed between the electrodes to separate them. The electric field formed by these multiple electrodes is closer to a sphere, resulting in a denser and more uniform electric field distribution at the tip of the adjustable bend section 220.

[0093] In some embodiments, the distal end of the adjustable bend section 220 is provided with a mesh-like support structure, and the electrode assembly 300 includes multiple annular electrodes arranged on the mesh-like support structure to form a mesh-like electrode structure. The mesh-like support structure is made of shape memory alloy and can be housed within the delivery sheath. After being released from the delivery sheath, it can return to its mesh-like shape. These mesh electrodes can be used for both mapping and ablation. The proximal handle still uses the bending control handle of the above embodiment to achieve bidirectional large-angle bending control. The bidirectional bending control of the dual-bend control catheter is more flexible, and the movable area of ​​the catheter tip (adjustable bend section tip) is larger, thus simultaneously improving the efficiency of the catheter's mapping and ablation. Figure 11As shown, E is a mesh-like support structure, and the number of supports can be set from 1 to 10 as needed. F is a ring electrode, and the number of ring electrodes on each support can also be set from 1 to 10 as needed. When the number of electrodes is large, the catheter can achieve high-density mapping and selective electrode (region) ablation, with higher accuracy in mapping and ablation. Because the functional characteristics of mapping and ablation are different, the design focus of the catheter is also different. The mapping function requires high mapping efficiency and accurate ECG signals, while the ablation function requires stable and reliable energy release from the catheter. However, both require reaching any part of the heart chamber as conveniently and quickly as possible. Therefore, this type of catheter usually needs a longer stroke, more selectable bending angles, and better maneuverability. Double-bend catheters are usually more advantageous in this regard. Conversely, single-bend catheters have a fixed bend shape. In clinical practice, situations often arise where the bend is too large or too small during mapping or ablation, especially for certain locations where the corresponding bend shape is difficult to reach. In cases of inconvenient operation, it is usually necessary to replace with other catheters, which poses certain safety risks to the patient. Dual-curve catheters can provide two different bend control options simultaneously, maximizing the clinical capabilities of a single catheter for mapping and ablation.

[0094] In some embodiments, the distal end of the adjustable bending section 220 is provided with an annular support structure; the electrode assembly 300 includes multiple annular electrodes, which are arranged on the annular support structure to form an annular electrode structure. The annular support structure is made of shape memory alloy and can be housed within the delivery sheath. After being released from the delivery sheath, it can return to its annular shape. These mesh electrodes can be used for both mapping and ablation. The proximal handle still uses the bending control handle of the above embodiment to achieve bidirectional large-angle bending control. The annular electrode design is suitable for pulmonary vein ablation, and the pulmonary veins are divided into the left pulmonary vein and the right pulmonary vein, located on the left and right sides of the left atrium, respectively. The double-bend catheter structure design allows the catheter tip to flexibly switch between the left and right pulmonary veins, resulting in higher ablation efficiency. Figure 12 As shown, G is a circular support structure, and the number of these supports can be set from 1 to 5 as needed. H is a ring electrode, and the number of these ring electrodes on each support can be set from 1 to 10 as needed. When the number of electrodes is large, high-density mapping and selective electrode (region) ablation can be achieved, resulting in higher accuracy in mapping and ablation.

[0095] In some embodiments, the distal end of the adjustable bending section 220 is provided with a five-claw-shaped support structure; the electrode assembly 300 includes multiple annular electrodes, which are arranged on the five-claw-shaped support structure to form a five-claw-shaped electrode structure. The five-claw-shaped support structure is made of shape memory alloy and can be housed within the delivery sheath. After being released from the delivery sheath, it can return to its five-claw shape. These claw-shaped electrodes can perform high-density mapping, and the proximal handle still uses the bending control handle of the above embodiment to achieve bidirectional large-angle bending control. The double-bend catheter has a larger working area at the catheter tip and a larger contact area with myocardial tissue, thus greatly improving the efficiency of high-density mapping. Figure 13 As shown, I is a five-pronged support structure, and the number of these supports can be set from 1 to 10 as needed. J is a ring electrode, and the number of these ring electrodes on each support can also be set from 1 to 10 as needed. When the number of electrodes is large, high-density mapping and selective electrode (region) ablation can be achieved, resulting in higher accuracy in mapping and ablation.

[0096] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0097] It should be noted that the above embodiments can be freely combined as needed. The above description is only a preferred embodiment of this application. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this application, and these improvements and modifications should also be considered within the protection scope of this application.

Claims

1. A bidirectional controlled bending conduit, characterized in that, include: The cable and the control handle, main body section and adjustable bending section connected in sequence; The bending control handle includes a housing and a coaxial component. The coaxial component is rotatably connected to the housing, and the rotation center of the coaxial component is its own axis. The outer side wall of the coaxial component is provided with an arc portion. The curvature center of the outer circumference of the arc portion does not coincide with the axis of the coaxial component. The two ends of the arc portion are located on a reference circle with the axis of the coaxial component as the center, and the arc portion is located outside the reference circle. The distal end of the pull wire passes through the main body section and is fixedly connected to the adjustable bending section; the proximal end of the pull wire is fixed to the coaxial member; when the coaxial member rotates around its own axis, the pull wire is coiled around the arc portion.

2. The bidirectional bending control conduit according to claim 1, characterized in that, The coaxial component has an arc-shaped groove extending circumferentially on its outer periphery. The bottom surface of the arc-shaped groove is located on the reference circle, and the arc portion is disposed within the arc-shaped groove.

3. The bidirectional bending control conduit according to claim 2, characterized in that, The arc portion does not protrude beyond the outer peripheral surface of the coaxial member, and a step portion is formed between the arc portion and the outer peripheral surface of the coaxial member to axially limit the pull wire.

4. The bidirectional bending control conduit according to claim 2, characterized in that, The pull wire includes a first pull wire and a second pull wire, which are respectively disposed on both sides of the arc portion; The coaxial component is provided with a first pull wire hole and a second pull wire hole on both sides of the arc portion along the circumferential direction; the proximal end of the first pull wire is fixed to the first pull wire hole; the proximal end of the second pull wire is fixed to the second pull wire hole; When the coaxial component rotates around its own axis, the first or second pull wire is coiled around the arc portion to achieve axial traction.

5. A bidirectional bending control conduit according to claim 4, characterized in that, The arc-shaped portion has a first arc-shaped protrusion at one end along the circumference, and a second arc-shaped protrusion at the other end along the circumference; After the first pull wire passes through the first pull wire hole, it wraps around the outer periphery of the first arc-shaped protrusion and then enters the main body section; after the second pull wire passes through the second pull wire hole, it wraps around the outer periphery of the second arc-shaped protrusion and then enters the main body section.

6. A bidirectional bending control conduit according to claim 1, characterized in that, The bending control handle also includes a dial, the dial has a first connecting part in the middle, and the coaxial member has a second connecting part. The second connecting part is coaxially connected to the first connecting part and prevents rotation in the circumferential direction, so as to achieve integrated rotation.

7. A bidirectional bending control conduit according to any one of claims 1-6, characterized in that, It also includes an electrode assembly, which is disposed in the adjustable bend section, and the electrodes in the electrode assembly are insulated from each other.

8. A bidirectional bending control conduit according to claim 7, characterized in that, The electrode assembly includes a head electrode and a plurality of ring electrodes arranged at intervals along the distal to proximal direction of the adjustable bending section; It also includes a pressure sensor, which is disposed between any two of the annular electrodes; The diameter of the head electrode ranges from 1.5 to 3 mm, and the width ranges from 1 to 4 mm; the diameter of the ring electrode ranges from 1.5 to 3 mm, and the width ranges from 0.5 to 4 mm. The distance between the head electrode and the adjacent annular electrode is 1 to 3 mm, the distance between the two annular electrodes on which the pressure sensor is located is 4 to 7 mm, and the distance between the remaining annular electrodes is 1 to 3 mm.

9. A bidirectional bending control conduit according to claim 7, characterized in that, The electrode assembly includes multiple annular electrodes, one of which is disposed inside the head end of the adjustable bend, and the remaining annular electrodes are spaced apart along the axial direction on the outer side wall of the adjustable bend.

10. A bidirectional bending control conduit according to claim 7, characterized in that, The distal end of the adjustable bending section is provided with a mesh-like support structure; The electrode assembly includes multiple ring electrodes, which are arranged on the mesh-like support structure to form a mesh-like electrode structure. Alternatively, the distal end of the adjustable bending section is provided with a ring-shaped support structure; The electrode assembly includes multiple ring electrodes, which are arranged on the ring-shaped support structure to form a ring electrode structure. Alternatively, the distal end of the adjustable bending section is provided with a five-claw-shaped support structure; The electrode assembly includes multiple ring electrodes, which are arranged on the five-claw-shaped support structure to form a five-claw-shaped electrode structure.

11. A bidirectional bending control conduit according to claim 7, characterized in that, The bidirectional bending control catheter is subjected to pulsed discharge ablation. The electrodes within the electrode group undergo unipolar pulse discharge with the external electrodes; or the electrodes within the electrode group undergo pulse discharge with each other.

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