Coronary sinus decapolar mapping catheter

Abstract

The application provides a coronary sinus decapole mapping catheter, the distal end of which is formed with a first bending control section and a second bending control section; an eccentric cavity is formed in the tube of the mapping catheter, and the mapping catheter further comprises a bending control assembly arranged in the eccentric cavity, which at least comprises a bending control wire, a compression spring and a tension spring; the distal end of the tension spring is fixedly connected relative to the distal end of the tube of the mapping catheter, the proximal end of the tension spring is fixedly connected with the distal end of the bending control wire, the bending control wire passes through the compression spring, the middle part of the bending control wire is formed with or connected with a first pressure bearing structure abutting against the distal end of the compression spring, and the eccentric cavity of the mapping catheter is formed with or connected with a second pressure bearing structure abutting against the proximal end of the compression spring; the bending resistance of the first bending control section and the second bending control section, the stiffness coefficient and the working stroke of the compression spring and the tension spring are configured to trigger the bending action of the first bending control section and the second bending control section in sequence or simultaneously through the pulling action of the bending control wire.

Description

Technical Field

[0001] This invention relates to the field of cardiac interventional medical device technology, and in particular to a coronary sinus ten-polar mapping catheter. Background Technology

[0002] In cardiac electrophysiology, the coronary sinus (CS) is a key anatomical structure for assessing left-sided cardiac electrical activity, diagnosing and ablating atrial tachycardia, atrial flutter, atrial fibrillation, and left-sided accessory pathways. The clinical goal is to simultaneously record the electrical signals of the coronary sinus and surrounding myocardium by inserting a multipolar mapping catheter into the CS, thereby determining the origin and activation sequence of arrhythmias and guiding ablation strategies. Current methods primarily involve percutaneous vascular puncture (such as through the femoral vein, internal jugular vein, or subclavian vein) to insert the mapping catheter into the right atrium, which then enters the coronary sinus through the right atrial ostium.

[0003] The coronary sinus ten-pole mapping catheters currently used in clinical practice are mainly divided into two categories: one is a pre-shaped catheter with a fixed curved shape, and the other is a catheter with a one-way, single-segment controllable bending function. Both of them have technical defects that are difficult to overcome.

[0004] One existing technology is a pre-shaped, fixed-curve, ten-electrode coronary sinus mapping catheter. The distal segment of this catheter is pre-formed with a fixed curve of a specific angle and curvature (such as a "pigtail bend" or a "straight bend") before leaving the factory. This curve cannot be adjusted in real-time within the body. Ten mapping electrodes are evenly spaced on the catheter body for collecting electrophysiological signals within the coronary sinus. This approach uses a polymer material to fabricate the catheter body, with a pre-formed curved curve of 90° to 180° at approximately 5-8 cm distally to accommodate the coronary sinus ostium, which exhibits relatively small anatomical variations. The proximal end of the catheter connects to an operating handle and a signal output plug. In clinical practice, the operator typically inserts the catheter into the right atrium via the internal jugular vein or subclavian vein approach. By rotating and pushing the catheter, the pre-shaped curved segment is hooked into the coronary sinus ostium and then pushed deeper into the sinus, reaching as far as the great cardiac vein region. However, this fixed-curve catheter has significant drawbacks: 1) Limited access options and high risk of puncture complications: The catheter relies on the internal jugular vein or subclavian vein for access, which not only increases the probability of vascular puncture-related complications but also leaves postoperative scars on the patient's neck or chest, affecting aesthetics; 2) High radiation exposure: The fixed-curve catheter cannot be dynamically adjusted according to the patient's anatomy. The operator needs to repeatedly rotate and advance and retract the catheter under X-ray fluoroscopy to find and hook the coronary sinus ostium, which takes a long time and significantly increases the radiation exposure dose for both the operator and the patient; 3) Low placement success rate: For patients with abnormal coronary sinus ostium positions (such as ostium too high, too low, or at a tricky angle), the fixed-curve catheter is difficult to enter the ostium smoothly and may even damage the ostium or atrial wall tissue; 4) Catheter dislodgement is easy: The catheter curvature cannot be precisely matched with the patient's anatomy. Cardiac pulsation or catheter traction can easily cause the catheter to dislodge from the coronary sinus, affecting the continuity and reliability of mapping.

[0005] Existing technology two is a coronary sinus ten-polar mapping catheter with unidirectional, single-segment controllable bending function. Unlike fixed-bend catheters, the distal end of this catheter can be pulled by an internal drawstring via a control mechanism (such as a knob or slider) on the handle, causing the distal end of the catheter to actively bend at a certain angle, thus achieving guided entry into the coronary sinus. This design incorporates a sliding or rotating control mechanism inside the handle, connected to the distal end of the catheter approximately 2-4 cm from the tip via a drawstring that runs along the inner lumen of the catheter body. When the operator manipulates the handle, the drawstring is pulled, causing the distal end of the catheter to bend to one side only in a single plane. The bending angle can be continuously adjusted within the range of 0°-180° via the control amplitude. In clinical practice, the operator typically inserts the catheter into the right atrium via the femoral vein, adjusts the distal bending angle to align with the coronary sinus ostium, and then pushes the catheter into the sinus. While this approach offers greater flexibility than fixed-bend catheters, it still suffers from several technical drawbacks: 1) Single-segment bending control cannot adapt to complex anatomy: The coronary sinus approach and its internal course are distributed in a three-dimensional, multi-planar manner (first running to the right anterior, then turning to the left posterior, and finally extending downwards). A single bending segment can only bend within a single plane, making it impossible to simultaneously adapt to the differences between the sinus ostium direction and the deep sinus interior direction, thus making it difficult to form a complex bending posture that matches the course of the coronary sinus; 2) Difficult entry under complex anatomy: For complex anatomical structures where the angle between the sinus ostium and the sinus body is large, single-bend control often results in significant tension between the catheter tip and the sinus wall after the catheter tip enters the sinus ostium, preventing further penetration into the deep sinus interior, and even causing it to bounce back into the right atrium; 3) Poor catheter stability: Only the distal end of the catheter has bending control capability, while the proximal end cannot provide effective support and compliance to the proximal segment of the coronary sinus. Cardiac pulsation or respiratory movements can easily cause the catheter to dislodge from the sinus into the right atrium, resulting in interruption of mapping signals and affecting the accuracy of diagnosis and treatment.

[0006] Therefore, an innovative mapping catheter is needed to overcome the problems of existing fixed-bend and single-segment controllable-bend coronary sinus ten-pole mapping catheters in clinical use, such as difficulty in placement, poor adaptability to complex anatomy, easy dislocation, large X-ray exposure for doctors and patients, and long operation time. Summary of the Invention

[0007] In view of this, embodiments of the present invention provide a coronary sinus ten-polar mapping catheter to eliminate or improve one or more defects existing in the prior art.

[0008] The distal end of the mapping catheter has a first bending control section and a second bending control section, the second bending control section being closer to the distal end of the catheter body than the first bending control section; an eccentric cavity is formed inside the mapping catheter, and the mapping catheter further includes a bending control assembly disposed within the eccentric cavity, the bending control assembly including at least a bending control wire, a compression spring, and a tension spring; wherein, the distal end of the tension spring is fixedly connected relative to the distal end of the mapping catheter body, and the proximal end of the tension spring is fixed to the distal end of the bending control wire. The control wire passes through the compression spring, and a first pressure-bearing structure abutting the distal end of the compression spring is formed or connected to the middle of the control wire. A second pressure-bearing structure abutting the proximal end of the compression spring is formed or connected to the eccentric cavity of the measuring guide tube. The bending resistance of the first and second control sections, the stiffness coefficient of the compression spring and the tension spring, and the working stroke are configured such that the bending action of the first and second control sections is triggered first, later, or simultaneously by the pulling action of the control wire.

[0009] In some embodiments, in the axial direction of the tube body, the first bending control section is located on the side of the compression spring near the proximal end of the tube body, the second bending control section is located on the side of the tension spring near the proximal end of the tube body, and the compression spring is located between the first bending control section and the second bending control section.

[0010] In some embodiments, the bending resistance of the first bending control segment is configured to be less than the bending resistance of the second bending control segment, in which case the first bending control segment triggers the bending action before the second bending control segment; or, the bending resistance of the first bending control segment is configured to be greater than the bending resistance of the second bending control segment, in which case the first bending control segment triggers the bending action after the second bending control segment; or, the bending resistance of the first bending control segment is configured to be equal to the bending resistance of the second bending control segment, in which case the first bending control segment and the second bending control segment trigger the bending action simultaneously.

[0011] In some embodiments, the tension of the control wire is applied to the tube body of the measuring guide tube through the compression spring, with the force point located on the side of the first control section near the far end of the tube body, causing the first control section to bend; when the working stroke of the compression spring is compressed to the maximum, the control force of the first control section reaches the maximum, and the bending amplitude of the first control section also reaches the maximum.

[0012] In some embodiments, the tension of the control wire is applied to the body of the measuring guide tube through the tension spring, with the force point located on the side of the second control section near the distal end of the tube body, causing the second control section to bend.

[0013] In some embodiments, the bending control assembly further includes a handle and a bending amplitude adjustment device. The bending amplitude adjustment device includes an adjustment head and a push rod. The adjustment head is adjustablely mounted on the handle. The proximal end of the push rod is fixedly connected to the adjustment head. The distal end of the push rod is fixedly connected to the second pressure-bearing structure or the distal end of the push rod forms the second pressure-bearing structure. The push rod is sleeved on the outside of the bending control wire. The adjusting head is threadedly connected to the handle or can be slidably connected. The push rod is a rigid structure in the axial direction of the tube body, and the push rod can bend with the bending of the first bending control section; When the adjusting head is threadedly connected to the handle, the adjusting head is rotated to drive the push rod and the second pressure-bearing structure to move along the axial direction of the tube body, thereby changing the initial deformation of the compression spring; With the adjusting head slidably connected to the handle, the adjusting head is pushed to drive the top rod and the second pressure-bearing structure to move along the axial direction of the tube body, thereby changing the initial deformation of the compression spring; the bending amplitude adjustment device also includes a locking structure for locking the adjusting head at different positions.

[0014] In some embodiments, the first pressure-bearing structure includes a pressure cap fixedly disposed on the bending control wire, or the first pressure-bearing structure includes an end face integrally formed on one side of the step shaft of the bending control wire.

[0015] In some embodiments, the compression spring is configured such that the maximum compressive force of its first quarter stroke is equal to the bending initiation resistance of the first bending control segment.

[0016] In some embodiments, the tension spring is configured such that the maximum tensile force of its first quarter stroke is equal to the bending initiation resistance of the second bending control segment.

[0017] In some embodiments, the distal end of the mapping catheter is configured as a segmented assembly structure consisting of at least two segments, with a connecting portion formed in at least the segment between the first and second bend control segments, the connecting portion being configured to be rotatably adjusted to a desired angle and then held in place.

[0018] This invention features two independent bending control sections at the distal end of the catheter, both of which can be controlled by the same bending control component. It innovatively employs a "spring-wire" composite structure and a combination of stiffness in the two bending control sections. Through a single, unidirectional operation of the wire, the two bending control positions can bend sequentially or simultaneously. In other words, a single manipulation action can trigger the bending of both bending control sections sequentially or simultaneously, achieving a composite bending shape similar to a "snake" or "stepped" shape. This adapts to the three-dimensional anatomy of the coronary sinus, enabling rapid, stable, and low-radiation catheter insertion.

[0019] Additional advantages, objects, and features of the invention will be set forth in part in the description which follows, and will also become apparent in part to those skilled in the art upon studying the description, or may be learned by practice of the invention. The objects and other advantages of the invention can be realized and obtained by means of the structures specifically pointed out in the description and drawings.

[0020] Those skilled in the art will understand that the objectives and advantages achievable with the present invention are not limited to those specifically described above, and that the above and other objectives achievable with the present invention will become clearer from the following detailed description. Attached Figure Description

[0021] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, are not intended to limit the scope of the invention. The components in the drawings are not drawn to scale but are merely illustrative of the principles of the invention. For ease of illustration and description of certain parts of the invention, corresponding portions in the drawings may be enlarged, i.e., may appear larger relative to other components in an exemplary device actually manufactured according to the invention. In the drawings: Figure 1 This is a schematic diagram of the distal end of the coronary sinus ten-polar mapping catheter in one embodiment of the present invention.

[0022] Figure 2 This is a schematic diagram of the distal end of the coronary sinus ten-polar mapping catheter and the bending control assembly in one embodiment of the present invention.

[0023] Figure 3 This is a schematic diagram of the eccentric cavity inside the coronary sinus ten-polar mapping catheter in one embodiment of the present invention.

[0024] Figure 4 This is an experimental data table showing the bending control wire stroke, bending control resistance of the bending control section, working stroke of the compression spring, and working stroke of the tension spring in one embodiment of the present invention.

[0025] Figure label: 100. Distal end of the pipe body; 101. First bend control section; 102. Second bend control section; 103. Connecting part; 104. Eccentric cavity; 200. Bending control assembly; 210. Bending control wire; 220. Compression spring; 221. First pressure-bearing structure; 222. Second pressure-bearing structure; 230. Tension spring; A. First force point; B. Second force point. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the embodiments and accompanying drawings. Here, the illustrative embodiments and descriptions of this invention are used to explain the invention, but are not intended to limit the invention.

[0027] It should also be noted that, in order to avoid obscuring the invention with unnecessary details, only the structures and / or processing steps closely related to the solution according to the invention are shown in the accompanying drawings, while other details that are not closely related to the invention are omitted.

[0028] It should be emphasized that the term "including / comprises" as used herein refers to the presence of a feature, element, step, or component, but does not exclude the presence or addition of one or more other features, elements, steps, or components.

[0029] It should also be noted that, unless otherwise specified, the term "connection" in this article can refer not only to a direct connection, but also to an indirect connection involving an intermediary.

[0030] In the following description, embodiments of the invention will be illustrated with reference to the accompanying drawings. In the drawings, the same reference numerals represent the same or similar parts, or the same or similar steps.

[0031] To address or alleviate the problems associated with existing fixed-bend and single-segment controllable-bend coronary sinus ten-pole mapping catheters in clinical use, such as placement difficulties, poor adaptability to complex anatomy, easy dislocation, high X-ray exposure for doctors and patients, and long operation time, this invention provides a ten-pole mapping catheter capable of actively and precisely matching the three-dimensional bending angle from the coronary sinus ostium to the deep sinus in stages or in a coordinated manner. This allows for rapid, stable, and low-radiation placement. The catheter features two independent bending control segments at its distal end, both controllable by a single bending control component. This invention innovatively employs a "spring-wire" composite structure and a combination of stiffness in the two bending control segments. Through a single unidirectional operation of the wire, the two bending positions can bend sequentially or in a coordinated manner. In other words, a single manipulation action can trigger the bending of both bending control segments sequentially or simultaneously, achieving a composite bending shape similar to a "snake" or "stepped" shape, perfectly matching the three-dimensional anatomy of the coronary sinus.

[0032] In some embodiments, such as Figure 1 As shown, the distal end 100 of the mapping catheter has a first bending section 101 and a second bending section 102, wherein the second bending section 102 is closer to the distal end of the catheter than the first bending section 101. It can be understood that in this invention, the distal end refers to the end of the mapping catheter that extends into the human body, enters the blood vessels and coronary sinus, that is, the side of the catheter tip closer to the lesion and farther from the operating handle; in this design, the second bending section 102 is closer to the distal end of the catheter, that is, located further forward and closer to the target area in the body.

[0033] like Figure 3 As shown, an eccentric cavity 104 is formed inside the mapping catheter. Figure 2 As shown, the mapping catheter also includes a bending control assembly 200 disposed in the eccentric cavity 104. The bending control assembly 200 includes at least: a bending control wire 210, a compression spring 220 and a tension spring 230.

[0034] The distal end of the tension spring 230 is fixedly connected to the distal end 100 of the measuring conduit, forming a second force point B on the conduit. The proximal end of the tension spring 230 is fixedly connected to the distal end of the control wire 210. The control wire 210 passes through the compression spring 220. Further, a first pressure-bearing structure 221 is formed or connected to the middle of the control wire 210, abutting against the distal end of the compression spring 220. A second pressure-bearing structure 222 is formed or connected within the eccentric cavity 104 of the measuring conduit, abutting against the proximal end of the compression spring 220, forming a first force point A on the conduit. The second pressure-bearing structure 222 itself supports / abuts against the inner wall or stepped surface of the eccentric cavity 104 of the conduit, converting the axial elastic force of the spring into a fulcrum constraint force on the conduit, thereby allowing the first control bending section 101 to bend smoothly.

[0035] It is understandable that the second pressure-bearing structure 222 is supported on the inner wall of the eccentric cavity 104, which can form a circumferential fit (with a very small gap). The second pressure-bearing structure 222 is radially limited and pressed against the inner wall of the eccentric cavity, forming a support structure. The pipe body can then form a bending moment fulcrum at the eccentric support stress position.

[0036] The bending resistance of the first bending control segment 101 and the second bending control segment 102, the stiffness coefficient of the compression spring 220 and the tension spring 230, and the working stroke are configured such that the bending action of the first bending control segment 101 and the second bending control segment 102 is triggered first, later, or simultaneously by the pulling action of the bending control wire 210. The catheter in this invention, by matching the bending resistance of the first and second bending control segments 102, as well as the stiffness coefficient and working stroke of the compression spring 220 and the tension spring 230, and relying on the pulling action of the bending control wire 210, can achieve any bending control mode as needed, such as sequential bending, synchronous bending, or independent bending of the first bending control segment 101 and the second bending control segment 102. This can match the three-dimensional tortuous course of the coronary sinus and the large individual anatomical differences, resulting in better catheter placement.

[0037] This invention utilizes parameter matching between the bending resistance of the control section and the spring stiffness coefficient and working stroke to achieve graded transmission of the control force with controllable timing, resulting in a linear and stable operating feel. This avoids sudden large-angle bending in a single operation and reduces the risk of abrasion and damage to blood vessels and the endocardium.

[0038] The segmented and time-controlled bending structure in this invention can finely adjust the posture of the first bending segment 101 (proximal segment) and the second bending segment 102 (distal segment) respectively, improve the stability of electrode contact, reduce catheter dislocation caused by heartbeat and respiratory movements, and ensure continuous, accurate and reliable electrophysiological mapping signals.

[0039] The single catheter in this invention can be adapted to various anatomical configurations and intraoperative shaping needs, eliminating the need to change to different curved catheters, simplifying the intraoperative operation process, shortening the operation time and reducing intraoperative radiation exposure.

[0040] As one possible approach, such as Figure 2 As shown, along the axial direction of the tube body, the first bending control section 101 is located on the side of the compression spring 220 near the proximal end of the tube body, and the second bending control section 102 is located on the side of the tension spring 230 near the proximal end of the tube body. The compression spring 220 is located between the first bending control section 101 and the second bending control section 102. Based on this axial layout, and in conjunction with the force transmission structure and parameter configuration of the bending control assembly 200, the bending sequence and force transmission path of the two bending control sections can be further optimized. This ensures that when the bending control wire 210 is pulled, the force transmission is more precise, and the action response of the two bending control sections is more stable. It also enables reliable switching between sequential bending and synchronous bending modes, while avoiding structural interference between components, ensuring smooth bending of the tube body without stress concentration.

[0041] It should be noted that, from a force analysis perspective, the distal end of the tension spring 230 is fixed to the farthest end of the catheter body, and the proximal end is fixed to the distal end of the control wire 210, bearing only tensile loads; the compression spring 220 is fitted on the outside of the control wire 210, and its two ends are respectively limited by the first pressure-bearing structure 221 (control wire 210) and the second pressure-bearing structure 222 (eccentric cavity 104), bearing only compressive loads; the control wire 210 is the core force transmission component, and the tension is input from the handle end and transmitted axially to: the compression spring 220, the first pressure-bearing structure 221, the tension spring 230, and the two control sections; the bending resistance F1 of the first control section 101 and the bending resistance F2 of the second control section 102 are the load forces of the catheter deformation.

[0042] The tension spring 230 and the compression spring 220 are matched with parameters to adapt to the bending requirements of the second bending control section 102 and the first bending control section 101, respectively. This achieves graded transmission of bending control force, flexible switching of bending sequence, and dynamic balance of mechanical state. It ensures precise alignment and stable contact of the distal tip, and achieves controllable shaping and support of the proximal bending control, effectively improving the adaptability, operational safety, and mapping reliability of the catheter in complex coronary sinus anatomy.

[0043] The functions of the tension spring 230 include, but are not limited to: 1. Connecting the distal end of the bending control wire 210 to the proximal end of the conduit. During the initial pulling phase of the bending control wire 210, the tension spring 230 first transmits the tension through its own elastic deformation, avoiding the instantaneous hard bending of the conduit caused by the hard pulling of the bending control wire 210, making the distal bending action start smoothly and without abrupt changes, thus improving the smoothness of the operation feel; 2. Matching the stiffness coefficient of the tension spring 230 with the bending resistance of the second bending section 102, it can precisely control the bending start timing of the second bending section 102. For example, the second bending section 102 is only driven to bend when the tension of the bending control wire 210 reaches the tension threshold of the tension spring 230. 1. The bending of the second control section 102 achieves temporal decoupling from the first control section 101, preventing both control sections from bending erratically at the same time; 2. After the second control section 102 is bent into place, the tension spring 230 can still provide continuous and stable elastic tension to compensate for the catheter micro-movement caused by heartbeat and respiratory movements, so that the tip electrode is always in contact with the endocardium, preventing the mapping signal from being interrupted and improving the continuity and reliability of electrophysiological recording; 3. The tension spring 230 is set with a rated working stroke. When stretched to the limit stroke, its own stiffness is close to rigid, which can limit the excessive pulling of the control wire 210, prevent the distal end of the catheter from being excessively bent, and reduce the risk of endocardial damage and catheter structural failure.

[0044] The functions of the compression spring 220 include, but are not limited to: 1. The compression spring 220 is fitted onto the bending control wire 210, with its two ends abutting against the first pressure-bearing structure 221 on the bending control wire 210 and the second pressure-bearing structure 222 inside the tube, respectively, to form an axial compression resistance threshold. 1. The bending control wire 210 needs to overcome the preload and compression force of the compression spring 220 to drive the first bending control section 101 to bend, thereby achieving the sequential bending sequence with the second bending control section 102; 2. The compression spring 220 isolates the force system of the near-end first bending control section 101 and the far-end second bending control section 102, so that the tension of the bending control wire 210 can be applied to the two bending control sections respectively through the compression / uncompression state of the compression spring 220, avoiding mutual interference between the two bending control sections during the bending process and ensuring the precision and controllability of the bending action; 3. The stiffness coefficient of the compression spring 220 determines the "softness and hardness" of the bending of the first bending control section 101, that is, the larger the stiffness coefficient, the smoother and more rigid the bending of the first bending control section 101; the smaller the stiffness coefficient, the smoother the bending. Meanwhile, the working stroke of the compression spring 220 directly limits the maximum axial displacement of the bending control wire 210, thereby constraining the limit bending angle of the first bending control section 101 and preventing excessive bending from causing the pipe to break; 4. When the tension of the bending control wire 210 is released, the compression spring 220 relies on its own elastic rebound to push the bending control wire 210 and the first pressure-bearing structure 221 to reset, causing the first bending control section 101 to straighten smoothly, avoiding the problem of the conduit getting stuck and unable to reset after bending, ensuring that the conduit can be repeatedly bent, and improving durability and operational error tolerance.

[0045] Example 1: Near-to-far curve control mode In this embodiment, by adjusting the wall thickness, material hardness, and structural design of the two bending control sections, the bending resistance F1 of the first bending control section 101 is made less than the bending resistance F2 of the second bending control section 102 (F1 < F2). Simultaneously, the stiffness coefficients of the compression spring 220 and the tension spring 230 are matched, ensuring that the stiffness coefficient of the compression spring 220 is less than that of the tension spring 230. This ensures that the tension of the bending control wire 210 first overcomes the bending resistance of the first bending control section 101 and the compression resistance of the compression spring 220 before triggering the bending of the second bending control section 102. The first bending control section 101 has a slightly thinner wall and uses a slightly more flexible polymer material, while the second bending control section 102 has a slightly thicker wall and slightly less flexible material. Both bending control sections retain installation space for the deca-pole measuring electrode, without affecting the electrical signal acquisition.

[0046] The cornering maneuver includes the following stages: 1. Initial state: No bending control force is applied to the mapping guide tube. The first bending control section 101 and the second bending control section 102 are both in a naturally straight state. The compression spring 220 and the tension spring 230 are both in an initial free state, without compression or tension deformation. 2. Tension initiation stage: The operator pulls the bending control wire 210 through the handle. The bending control wire 210 retracts axially, which first drives the first pressure bearing structure 221 to compress the compression spring 220. Since the spring 220 has a small stiffness coefficient and the bending resistance F1 of the first bending control section 101 is small, the relatively small pulling force of the bending control wire 210 can overcome the above resistance, causing the compression spring 220 to begin axial compression. At the same time, the first bending control section 101 first undergoes bending deformation, and the bending angle gradually increases with the pulling stroke of the bending control wire 210. 3. Second bending control section 102 trigger stage: Continue to pull the bending control wire 210. After the compression spring 220 is compressed to the preset stroke, the tension of the bending control wire 210 is further transmitted to the tension spring 230. Since the tension spring 230 has a large stiffness coefficient and the bending resistance F2 of the second bending control section 102 is large, the tension reaches the trigger threshold at this time. The tension spring 230 begins to stretch, causing the second bending control section 102 to bend slowly. 4. Reset phase: Release the tension of the bending control wire 210, the compression spring 220 rebounds elastically, pushing the first pressure-bearing structure 221 and the bending control wire 210 back, and the first bending control section 101 resets and straightens first; then the tension spring 230 rebounds, driving the second bending control section 102 to reset and straighten, and both bending control sections return to their initial state.

[0047] This proximal-to-distal control bending mode is adaptable to complex and tortuous coronary sinuses. Prioritizing the bending of the proximal first control segment 101 allows for large-angle shaping of the proximal end of the catheter, providing stable support for the distal second control segment 102. This facilitates the catheter's smooth passage through the tortuous proximal segment of the coronary sinus, avoiding catheter jamming caused by the distal bending. After the proximal bending provides support, fine-tuning of the distal second control segment 102 allows for precise adjustment of the mapping electrode's contact angle, adapting to the anatomical orientation deep within the coronary sinus and improving mapping accuracy.

[0048] The operator can first adjust the overall posture of the catheter by controlling the proximal bend, and then fine-tune the distal end. The operation logic is clear, which is especially suitable for complex cases with stenosis and tortuosity in the proximal coronary sinus, and reduces radiation exposure caused by repeated adjustments.

[0049] like Figure 4 As shown, Figure 4 This is a chart showing the experimental data for this embodiment. The horizontal axis represents the bending force and spring force of the bending control section (unit: N); the vertical axis represents the bending control section stroke (0-9) and the spring's working stroke (unit: mm). The blue line represents compression spring 1 (i.e., the spring under compression), the red line represents bending control section 1 (i.e., the first bending control section), the green line represents tension spring 2 (i.e., the spring under tension), and the purple line represents bending control section 2 (i.e., the second bending control section). The bending control wire stroke is actually the sum of the strokes of the two springs.

[0050] In the initial pulling stage (stroke 0-3): the bending control wire begins to pull, and when the stroke of the compression spring (blue line) reaches 1, the first bending control segment (red line) immediately overcomes its own bending initiation resistance and begins to bend; in this stage, only the force on the compression spring and the first bending control segment increases synchronously with the stroke, the deformation of the tension spring (green line) is very small, and it has not reached the bending initiation threshold of the second bending control segment, so the second bending control segment remains straight and does not start bending for the time being.

[0051] During the mid-range pulling stage (stroke 3-5): As the bending wire stroke continues to increase, the stroke of the compression spring gradually increases to 5, and the bending amplitude of the first bending section gradually approaches the limit; at the same time that the stroke of the compression spring reaches 5, the corresponding stroke of the tension spring reaches 3. At this time, the tension of the tension spring just overcomes the bending initiation resistance of the second bending section, and the second bending section begins to bend.

[0052] During the large stroke pulling stage (stroke 5-9): the compression spring and the first control bending section are close to their limit, and the force increase tends to be gradual; the tension spring and the second control bending section continue to be stressed as the control bending wire stroke increases, and the second control bending section enters the continuous bending deformation stage, forming a spatial composite bending shape together with the already shaped first control bending section.

[0053] Example 2: Far-to-near cornering control mode In this embodiment, by optimizing the structural parameters of the two bending control sections, the bending resistance F1 of the first bending control section 101 is made greater than the bending resistance F2 of the second bending control section 102 (F1 > F2). The stiffness coefficients of the dual springs are matched so that the stiffness coefficient of the tension spring 230 is less than that of the compression spring 220, ensuring that the tension of the bending control wire 210 prioritizes overcoming the bending resistance of the second bending control section 102 and the tensile resistance of the tension spring 230, thus delaying the bending triggering of the first bending control section 101. The first bending control section 101 has a thicker tube wall and higher material hardness, undertaking the main support and shaping functions; the second bending control section 102 has a thinner tube wall and higher flexibility, facilitating fine-tuning. The ten-electrode calibration electrodes are evenly distributed between the two bending control sections to ensure signal acquisition coverage.

[0054] The cornering maneuver includes the following stages: 1. Initial state: The catheter is straight, the double control bend section and double spring are in their natural state, and the control wire 210 has no tension. 2. Distal bending stage: The operator pulls the control wire 210. Due to the small spring coefficient of the tension spring 230 and the small bending resistance F2 of the second control segment 102, the initial tension of the control wire 210 can pull the tension spring 230 to stretch, causing the second control segment 102 to bend first, so as to achieve precise alignment of the catheter tip and facilitate alignment with the coronary sinus ostium. 3. Proximal posterior bending stage: Continue to increase the traction stroke of the control wire 210. After the tension spring 230 is stretched to its limit working stroke, the tension is further transmitted to the first pressure-bearing structure 221, compressing the compression spring 220 (the compression spring 220 has a large stiffness coefficient). When the tension overcomes the compression resistance of the compression spring 220 and the bending resistance F1 of the first control segment 101, the first control segment 101 begins to bend, providing stable support for the catheter and pushing the catheter into the deep coronary sinus. 4. Reset phase: When the control wire 210 is released, the tension spring 230 rebounds first, driving the second control section 102 to reset; then the compression spring 220 rebounds, pushing the control wire 210 back, the first control section 101 resets, and the catheter returns to a straight state.

[0055] This distal-to-proximal control bending mode can improve the success rate of sinus ostium entry. The distal second control bending segment 102 is finely bent first, which can flexibly adjust the head angle and accurately align with the coronary sinus ostium. It is especially suitable for patients with abnormal coronary sinus ostium position (opening too high, too low, or at a tricky angle), avoiding the difficulty of head alignment caused by proximal bending first. The distal flexible bending first has a gentle head posture, which can reduce the scraping and damage to the coronary sinus ostium and endocardium, and reduce the risk of vascular complications. First, the distal end is finely adjusted for alignment, and then the proximal end is shaped and supported, making it suitable for most routine and mildly complex anatomical cases. The surgeon can flexibly control the bending range according to the intraoperative situation, with a linear feel and high fault tolerance.

[0056] Example 3: Synchronous Bending Control Mode In this embodiment, the bending resistance of the first bending control section 101 and the second bending control section 102 are configured to be equal (F1=F2), meaning that the wall thickness, material hardness, and structural design of the two bending control sections are completely identical. Simultaneously, the stiffness coefficients of the compression spring 220 and the tension spring 230 are matched to ensure that the stiffness coefficients, initial preload, and working stroke of the two springs are perfectly matched. This ensures that when the bending control wire 210 is pulled, the tension can be synchronously transmitted to both bending control sections, triggering synchronous bending in both sections. Ten-pole measuring electrodes are evenly distributed in both bending control sections to ensure uniform electrode contact and stable signal acquisition during synchronous bending.

[0057] The cornering maneuver includes the following stages: 1. Initial state: The catheter is straight, both control bends and both springs are in their natural state, and the control wire 210 has no tension; 2. Synchronous bending stage: The surgeon pulls the control wire 210, and the tension is simultaneously transmitted to the tension spring 230 and the compression spring 220. Since the spring coefficients of the two springs are matched and the bending resistance of the two control segments is equal, the tension spring 230 is stretched synchronously and the compression spring 220 is compressed synchronously, which causes the first control segment 101 and the second control segment 102 to bend simultaneously. The bending angle of the two control segments increases synchronously with the pulling stroke of the control wire 210, forming a symmetrical or composite bend that adapts to the course of the coronary sinus. 3. Limit state: When the bending control wire 210 is pulled to the maximum stroke, the compression spring 220 and the tension spring 230 both reach their limit working stroke, and the two bending control sections reach the maximum bending degree at the same time, maintaining the stability of the compound bend; 4. Reset stage: Loosen the bending control screw 210, and the two springs will rebound synchronously, driving the two bending control sections to reset and straighten synchronously without any sequential or obstructed movement.

[0058] This synchronous bending mode is suitable for symmetrical coronary sinuses. Synchronous bending can form a uniform composite bend, which is suitable for the smooth course and uniform curvature of the coronary sinus anatomy. The catheter has good overall wall adhesion and stable electrode contact. There is no need to adjust the two control sections in stages. The overall shaping of the catheter can be completed with a single pull, which simplifies the operation process, shortens the operation time, and reduces the radiation exposure of the operator and the patient. The two control sections are stressed and deformed synchronously, avoiding tube fatigue or breakage caused by excessive stress on a single section, improving the durability of the catheter, and ensuring continuous and stable mapping signals, reducing signal interruption caused by posture changes.

[0059] The above three embodiments achieve three modes of control: near-to-far, far-to-near, and simultaneous control of the bending by adjusting the bending resistance of the dual-control bending segment and matching the parameters of the dual springs. These modes can be adapted to coronary sinus scenarios with different anatomical complexities, meet the diverse clinical mapping operation needs, and improve the safety, accuracy, and efficiency of surgery.

[0060] In some embodiments, the tension of the control wire 210 is applied to the tube body of the measuring guide tube through the compression spring 220. The force point (first force point A) is located on the side of the first control section 101 near the distal end 100 of the tube body, causing the first control section 101 to bend. When the working stroke of the compression spring 220 is compressed to the maximum, the bending force of the first control section 101 reaches the maximum, and the bending amplitude of the first control section 101 also reaches the maximum.

[0061] In this embodiment, the compression spring 220 forms an adjustable axial force transmission node between the tube body and the bending control wire 210. The tension of the bending control wire 210 needs to be transmitted to the force point on the tube body and drive the first bending control section 101 to bend through the compression process of the compression spring 220. The working stroke of the compression spring 220 limits the maximum axial displacement that the bending control wire 210 can act on the force point, thereby directly determining the limit bending amplitude of the first bending control section 101. When the compression spring 220 is compressed, the stroke of the bending control wire 210 is locked, and no additional bending force can be applied to the tube body. Therefore, the bending amplitude of the first bending control section 101 no longer increases.

[0062] In some embodiments, the tension of the control wire 210 acts on the tube body of the measuring guide tube through the tension spring 230. The force point (second force point B) is located on the side of the second control section 102 near the distal end 100 of the tube body, causing the second control section 102 to bend. In this embodiment, the distal end of the tension spring 230 is fixed to the farthest end of the tube body, and the proximal end is fixedly connected to the distal end of the control wire 210, forming a rigid force transmission path. The axial tension of the control wire 210 acts directly on the second force point B of the distal end 100 of the tube body through the tension spring 230, causing the force point to be subjected to a tension towards the proximal end, thereby driving the second control section 102, with that point as the fulcrum, to bend towards the control wire 210. The stiffness coefficient and working stroke of the tension spring 230 can be matched with the bending resistance of the second control section 102, realizing precise control of the bending timing, bending rate, and maximum bending amplitude of the second control section 102.

[0063] It should be noted that in this invention, neither the compression spring 220 nor the tension spring 230 undergoes arc-shaped bending deformation with the control bending section; both only undergo elastic deformation along the axial direction of the tube. The compression spring 220 is housed within the eccentric cavity 104 of the measuring guide tube and is radially limited by the tube wall. It can only compress or rebound axially and cannot undergo arc-shaped bending with the first control bending section 101. Its compression stroke only changes the axial length, and the spring body always remains in a straight state. The tension spring 230 is arranged along the axial direction of the tube, with its two ends fixed to the distal end 100 of the tube and the distal end of the control bending wire 210, respectively. It is also constrained by the inner wall of the tube and can only undergo tensile or restorative deformation axially. It will not bend with the second control bending section 102.

[0064] In some embodiments, the bending control assembly 200 further includes a handle and a bending amplitude adjustment device. Optionally, the handle is a handheld component operated by the surgeon, with an internal cavity for accommodating the bending amplitude adjustment device and the proximal structure of the bending control wire 210, and an external anti-slip texture for easy gripping and manipulation by the surgeon.

[0065] The bending amplitude adjustment device may include an adjustment head and a push rod, which are integrally formed or welded together to ensure the stability of force transmission and prevent loosening or detachment during adjustment. The adjustment head is adjustablely mounted on the handle and can be integrally fitted to the end of the handle away from the tube body. The outer circumferential surface of the adjustment head is adapted to the end opening of the handle, ensuring smooth adjustment and achieving good sealing to prevent bodily fluids, dust, etc. from entering the handle and affecting the working stability of internal components. The proximal end of the push rod is fixedly connected to the adjustment head. The connection method can be threaded, adhesive, or snap-fit, with threaded connection being preferred for easy assembly, disassembly, and maintenance. The distal end of the push rod extends into the eccentric cavity 104 of the tube body and is fixedly connected to the second pressure-bearing structure 222, or the distal end of the push rod can be directly integrally formed to form the second pressure-bearing structure 222 without the need for additional connecting parts, simplifying the structure and reducing assembly difficulty.

[0066] At this point, to ensure that the pressure spring 220 transmits its force to the conduit body through the second pressure-bearing structure 222, the outer diameter of the pressure spring 220 can be the same as the inner diameter of the eccentric cavity, so that the outer diameter of the second pressure-bearing structure is radially fitted to the inner wall of the eccentric cavity. The second pressure-bearing structure 222 can slide back and forth to adjust the preload of the pressure spring 220, but it is held in place by the inner wall of the eccentric cavity on the left and right sides; the axial thrust of the pressure spring 220 is pressed against the side wall of the eccentric cavity through the second pressure-bearing structure 222, transmitting the force to the conduit body, which can form a fulcrum to allow the bending section to bend.

[0067] Furthermore, the push rod is coaxially sleeved on the outside of the bending control wire 210. The inner diameter of the push rod is slightly larger than the outer diameter of the bending control wire 210. This ensures that the bending control wire 210 can move freely axially inside the push rod, while also preventing excessive friction between the bending control wire 210 and the push rod, reducing component wear, and extending service life.

[0068] The push rod is a rigid structure in the axial direction of the tube body, which can accurately transmit axial force. The push rod also has a certain degree of flexibility, which can bend with the bending of the first bending control section 101 without interfering with the shaping of the conduit.

[0069] The adjustment head and the handle can be connected by either a threaded connection or a sliding connection, which can be adapted to different clinical operation needs.

[0070] Firstly, when the adjusting head is threadedly connected to the handle, the adjusting head, by being rotated, drives the push rod and the second pressure-bearing structure 222 to move along the axial direction of the tube body, thereby changing the initial deformation of the compression spring 220. Optionally, the outer circumferential surface of the adjusting head is provided with an external thread, and the inner side of the opening at the end of the handle is provided with an internal thread that meshes with the external thread. The two are adjusted and assembled through threaded engagement. The thread can be designed with fine teeth, which has good self-locking properties, and can prevent the adjusting head from loosening due to intraoperative vibration after adjustment, thus ensuring the stability of the initial deformation of the compression spring 220.

[0071] During the procedure, the operator rotates the adjustment head according to the patient's coronary sinus anatomy and mapping requirements. Since the adjustment head is threadedly engaged with the handle, the rotation action can be converted into axial movement of the adjustment head along the tube axis, which in turn drives the push rod fixedly connected to the adjustment head to move axially synchronously. The distal end of the push rod drives the second pressure-bearing structure 222 to move closer to or further away from the compression spring 220 along the tube axis. When the push rod pushes the second pressure-bearing structure 222 towards the compression spring 220, the compression spring 220 is further pre-compressed, and the initial deformation increases. When the push rod drives the second pressure-bearing structure 222 away from the compression spring 220, the pre-compression of the compression spring 220 decreases, and the initial deformation decreases, thereby achieving stepless adjustment of the initial deformation of the compression spring 220, and thus precisely controlling the bending start threshold and maximum bending amplitude of the first bending control segment 101.

[0072] Secondly, when the adjusting head and the handle are slidably connected, the adjusting head is pushed to drive the top rod and the second pressure-bearing structure 222 to move along the axial direction of the tube body, so as to change the initial deformation of the compression spring 220; the bending amplitude adjustment device also includes a locking structure for locking the adjusting head at different gear positions.

[0073] Optionally, the outer side of the handle is provided with an axial groove, and the adjusting head is slidably assembled in the groove. The inner side of the groove is provided with a limiting protrusion, and the inner side of the adjusting head is provided with a limiting groove that matches the limiting protrusion. This can prevent the adjusting head from rotating circumferentially during the sliding process and ensure the accuracy of the adjustment action.

[0074] According to clinical needs, the operator pushes the adjusting head along the axial groove of the handle. The adjusting head drives the push rod to move synchronously along the tube axis. The distal end of the push rod drives the second pressure-bearing structure 222 to move closer to or further away from the compression spring 220, thereby changing the initial deformation of the compression spring 220. Pushing the adjusting head towards the tube causes the second pressure-bearing structure 222 to compress the compression spring 220, increasing the initial deformation; pulling the adjusting head away from the tube causes the compression spring 220 to release, decreasing the initial deformation.

[0075] Optionally, the locking structure can be in the form of elastic steel balls cooperating with positioning slots. For example, the inner side of the adjusting head is provided with elastic steel balls, and the inner side of the slide groove is provided with multiple positioning slots spaced apart along the axial direction. The number of positioning slots is set according to the adjustment gear requirements (such as 3-5 gears). When the adjusting head slides to the target gear, the elastic steel balls are inserted into the corresponding positioning slots, reliably locking the adjusting head at that gear position, preventing the adjusting head from sliding due to accidental touch or vibration during the operation, ensuring that the initial deformation of the compression spring 220 remains stable, thereby ensuring the stability of the bending amplitude of the first bending control section 101.

[0076] In some embodiments, such as Figure 2 As shown, the first pressure-bearing structure 221 includes a pressure cap fixedly disposed on the bending control wire 210, or the first pressure-bearing structure 221 includes an annular end face integrally formed on one side of the stepped shaft of the bending control wire 210. The pressure cap can be fixed relative to the bending control wire 210 by interference fit, bonding or snap-fit ​​limiting method, and can stably abut against the distal end face of the compression spring 220 to realize reliable transmission of axial force; the stepped end face formed by the diameter change of the bending control wire 210 itself is directly used as the pressure-bearing contact surface, without the need for additional parts, the structure is simpler, the assembly process is less, and the coaxiality and stress stability are better.

[0077] In some embodiments, the compression spring 220 is configured such that the maximum compressive force of its first quarter stroke is equal to the bending initiation resistance of the first bending control section 101. Here, the first quarter stroke of the compression spring 220 refers to the stroke range from its initial free state (no compression deformation) to when the compression reaches 1 / 4 of its total rated working stroke; the maximum compressive force is the axial elastic reaction force generated by the compression spring 220 at the end of this 1 / 4 stroke; the bending initiation resistance of the first bending control section 101 refers to the minimum resistance that the first bending control section 101 needs to overcome to begin bending deformation from its naturally straight state, and this resistance is determined by the tube wall thickness, material hardness, and structural design of the first bending control section 101.

[0078] This configuration controls the initiation timing of bending in the first bending control segment 101. When the bending control wire 210 pulls and drives the first pressure-bearing structure 221 to compress the compression spring 220, the compression spring 220 gradually compresses. When its compression stroke reaches 1 / 4 of its total stroke, the maximum compressive force generated just overcomes the bending initiation resistance of the first bending control segment 101, at which point the first bending control segment 101 begins to bend. When the compression amount of the compression spring 220 has not reached the first 1 / 4 stroke, the compressive force generated is less than the bending initiation resistance of the first bending control segment 101, and the first bending control segment 101 remains straight. This achieves precise definition of the bending initiation timing of the first bending control segment 101, avoiding it from starting too early or too late, and ensuring the timing accuracy with the second bending control segment 102. At the same time, this configuration makes the operation feel of the first bending control segment 101 more gentle, without sudden resistance, improving the smoothness and controllability of the operator's operation.

[0079] In some embodiments, the tension spring 230 is configured such that the maximum tensile force of its first quarter stroke is equal to the bending initiation resistance of the second bending control section 102. Here, the first quarter stroke of the tension spring 230 refers to the stroke range from its initial free state (no tensile deformation) to when the tensile amount reaches 1 / 4 of its total rated working stroke; the maximum tensile force is the axial elastic tension generated by the tension spring 230 at the end of this 1 / 4 stroke; the bending initiation resistance of the second bending control section 102 refers to the minimum resistance that the second bending control section 102 needs to overcome to begin bending deformation from its naturally straight state, and is determined by the tube structure parameters of the second bending control section 102.

[0080] This configuration controls the initiation timing of bending in the second bending section 102. When the bending control wire 210 pulls the tension spring 230, the tension spring 230 gradually stretches. When its stretching stroke reaches 1 / 4 of its total stroke, the maximum tensile force generated just overcomes the bending initiation resistance of the second bending section 102, at which point the second bending section 102 begins to bend. When the tension spring 230 has not reached the first 1 / 4 of its stroke, the tensile force it generates is less than the bending initiation resistance of the second bending section 102, and the second bending section 102 remains straight.

[0081] In some embodiments, the distal end 100 of the mapping catheter is configured as a segmented assembly structure consisting of at least two segments. A connecting portion 103 is formed in at least the segment between the first bending control segment 101 and the second bending control segment 102. This connecting portion 103 serves as the junction of the two segments and also as the boundary between the two bending control segments. The connecting portion 103 is configured to be rotated to the desired angle and then fixed. The connecting portion 103 can be pre-controlled to rotate around the axis of the catheter and adjusted to the target angle, thus achieving angle adaptation between the two segments and meeting the shaping requirements of different anatomical scenarios. Simultaneously, to accommodate the rotational movement of the connecting portion 103, the eccentric cavity 104 within the catheter is appropriately enlarged at the corresponding position of the connecting portion 103. The enlarged cavity space provides sufficient leeway for the movement of the bending control wire 210, ensuring that the bending control wire 210 can rotate accordingly when the connecting portion 103 rotates and the catheter bends, without jamming or interruption of force transmission due to angle adjustment of the connecting portion 103.

[0082] Furthermore, the docking part 103 adopts a detachable structure (such as a plug-in connection), and the splice is sealed to prevent body fluids and impurities from entering the tube and affecting the working stability of the internal spring and the bending control wire 210. The rotation adjustment range of the docking part 103 is 360°, which allows the front and rear bending control sections to be twisted relative to each other in the circumference. The angle can be adjusted according to the direction of the coronary sinus and the operator's operating needs. After adjustment, it is fixed by its own damping and will not be affected by heartbeat or operation vibration.

[0083] This invention enables 360° controllable bending of the distal end of the catheter without the need for multiple ligatures. The orientation and spatial curvature of the catheter tip can be adjusted arbitrarily according to the location and angle of the patient's coronary sinus opening. This results in faster alignment, a higher success rate of placement, reduced intraoperative fluoroscopic adjustments, lower radiation exposure, and improved electrode contact stability, thus reducing the risk of dislocation.

[0084] The coronary sinus ten-polar mapping catheter in this embodiment of the invention adopts a dual-segment independent bending control design, which allows the catheter to be adjusted like a "flexible snake". First, the proximal bending shape is adjusted to align with the sinus ostium, and then the distal bending shape is adjusted to penetrate deeper into the sinus body. Even in the face of variable anatomy, it can be easily inserted, which significantly improves the success rate of the operation.

[0085] The coronary sinus ten-polar mapping catheter in this embodiment of the invention does not require repeated trial-and-error adjustments under X-ray. The operator can quickly enter the coronary sinus by touch and by using a preset bend, which greatly shortens the fluoroscopy time, significantly reduces the radiation exposure time, and reduces radiation damage to both doctors and patients.

[0086] The coronary sinus ten-polar mapping catheter placement procedure in this embodiment of the invention is simplified and precise, avoiding repeated dislodgement and retry, and significantly shortening the overall operation time, thereby reducing the patient's operation time, anesthesia risks and patient discomfort.

[0087] The dual-segment bending control of the coronary sinus ten-pole mapping catheter in this embodiment of the invention enables the catheter to be in an "adaptive" contact state within the coronary sinus, ensuring stable and uniform contact with the sinus wall and preventing it from dislodging due to heartbeats. This guarantees long-term, high-fidelity signal recording and provides a reliable basis for accurate mapping and ablation navigation of complex arrhythmias.

[0088] In this invention, features described and / or illustrated for one embodiment may be used in the same or similar manner in one or more other embodiments, and / or combined with or in place of features of other embodiments.

[0089] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, various modifications and variations of the embodiments of the present invention are possible. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A coronary sinus ten-polarity mapping catheter, characterized in that, The distal end (100) of the calibration catheter has a first bending section (101) and a second bending section (102), wherein the second bending section (102) is closer to the distal end of the catheter than the first bending section (101); The mapping catheter has an eccentric cavity (104) formed inside it. The mapping catheter also includes a bending control assembly (200) disposed in the eccentric cavity (104). The bending control assembly (200) includes at least: a bending control wire (210), a compression spring (220), and a tension spring (230). The distal end of the tension spring (230) is fixedly connected to the distal end (100) of the measuring catheter, the proximal end of the tension spring (230) is fixedly connected to the distal end of the control wire (210), the control wire (210) passes through the compression spring (220), a first pressure-bearing structure (221) is formed or connected in the middle of the control wire (210) against the distal end of the compression spring (220), and a second pressure-bearing structure (222) is formed or connected in the eccentric cavity (104) of the measuring catheter against the proximal end of the compression spring (220). The bending resistance of the first bending control section (101) and the second bending control section (102), the stiffness coefficient of the compression spring (220) and the tension spring (230) and the working stroke are configured such that the bending action of the first bending control section (101) and the second bending control section (102) is triggered first, later or simultaneously by the pulling action of the bending control wire (210), so that there are near-to-far bending control mode, far-to-near bending control mode and synchronous bending control mode; In the near-to-far bending control mode, the bending resistance of the first bending control segment (101) is less than the bending resistance of the second bending control segment (102), and the stiffness coefficient of the compression spring (220) is less than the stiffness coefficient of the tension spring (230). In the far-to-near bending control mode, the bending resistance of the first bending control segment (101) is greater than the bending resistance of the second bending control segment (102); the stiffness coefficient of the tension spring (230) is less than the stiffness coefficient of the compression spring (220); In the synchronous bending mode, the bending resistance of the first bending segment (101) and the second bending segment (102) are equal, and the stiffness coefficient of the compression spring (220) and the tension spring (230) are equal.

2. The coronary sinus ten-polar mapping catheter according to claim 1, characterized in that, In the axial direction of the tube body, the first bending control section (101) is located on the side of the compression spring (220) near the proximal end of the tube body, the second bending control section (102) is located on the side of the tension spring (230) near the proximal end of the tube body, and the compression spring (220) is located between the first bending control section (101) and the second bending control section (102).

3. The coronary sinus ten-polar mapping catheter according to claim 1, characterized in that, The bending resistance of the first bending control segment (101) is configured to be less than that of the second bending control segment (102), in which case the first bending control segment (101) triggers the bending action before the second bending control segment (102); or, The bending resistance of the first bending control segment (101) is configured to be greater than that of the second bending control segment (102), in which case the first bending control segment (101) triggers the bending action after the second bending control segment (102); or, The bending resistance of the first bending control segment (101) is configured to be equal to the bending resistance of the second bending control segment (102). At this time, the first bending control segment (101) and the second bending control segment (102) trigger bending actions simultaneously.

4. The coronary sinus ten-polar mapping catheter according to claim 2, characterized in that, The tension of the bending control wire (210) is applied to the tube body of the measuring guide tube through the compression spring (220). The point of force is located on the side of the first bending control section (101) near the distal end (100) of the tube body, causing the first bending control section (101) to bend. When the working stroke of the compression spring (220) is compressed to the maximum, the bending force of the first bending control section (101) reaches the maximum, and the bending amplitude of the first bending control section (101) also reaches the maximum.

5. The coronary sinus ten-polar mapping catheter according to claim 2, characterized in that, The tension of the control wire (210) is applied to the body of the measuring guide tube through the tension spring (230). The point of force is located on the side of the second control section (102) near the distal end (100) of the tube body, causing the second control section (102) to bend.

6. The coronary sinus ten-polar mapping catheter according to claim 1, characterized in that, The bending control assembly (200) also includes a handle and a bending amplitude adjustment device. The bending amplitude adjustment device includes an adjustment head and a push rod. The adjustment head is adjustablely installed at the handle. The proximal end of the push rod is fixedly connected to the adjustment head. The distal end of the push rod is fixedly connected to the second pressure-bearing structure (222) or the distal end of the push rod forms the second pressure-bearing structure (222). The push rod is sleeved on the outside of the bending control wire (210). The adjusting head is threadedly connected to the handle or can be slidably connected. The push rod is a rigid structure in the axial direction of the tube body, and the push rod can bend with the bending of the first bending control section (101); When the adjusting head is threadedly connected to the handle, the adjusting head is rotated to drive the top rod and the second pressure-bearing structure (222) to move along the axial direction of the tube body, thereby changing the initial deformation of the compression spring (220); When the adjusting head is slidably connected to the handle, the adjusting head is pushed to drive the top rod and the second pressure-bearing structure (222) to move along the axial direction of the tube body, so as to change the initial deformation of the compression spring (220); the bending amplitude adjustment device also includes a locking structure for locking the adjusting head at different gear positions.

7. The coronary sinus ten-polar mapping catheter according to claim 1, characterized in that, The first pressure-bearing structure (221) includes a pressure cap fixedly disposed on the bending control wire (210), or the first pressure-bearing structure (221) includes an end face integrally formed on one side of the stepped shaft of the bending control wire (210).

8. The coronary sinus ten-polar mapping catheter according to claim 1, characterized in that, The compression spring (220) is configured such that its maximum compressive force in the first quarter of its stroke is equal to the bending initiation resistance of the first bending control segment (101).

9. The coronary sinus ten-polar mapping catheter according to claim 8, characterized in that, The tension spring (230) is configured such that the maximum tensile force of its first quarter stroke is equal to the bending initiation resistance of the second bending control segment (102).

10. The coronary sinus ten-polar mapping catheter according to claim 1, characterized in that, The distal end (100) of the calibration catheter is configured as a segmented combination structure consisting of at least two segments, and a docking portion (103) is formed in the segment between the first bending segment (101) and the second bending segment (102). The docking portion (103) is configured to be able to be rotated and adjusted to the required angle and then kept fixed.

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