Guide tube and conveying system for conveying heart valve prosthesis

Abstract

The invention discloses a guiding pipe and a conveying system using the guiding pipe. The guide tube comprises a tube body, a first guide tube and a second guide tube, the snake bone pipe is provided with a second pipe cavity, a pipe body of the snake bone pipe at least comprises a first pipe section and a second pipe section, and the first pipe section and the second pipe section are bent reversely when the same traction force is applied; the traction wire penetrates through the first tube cavity and the second tube cavity to be connected with the far end of the first tube section, and the near end is connected with a first control piece arranged at the near end of the tube body; the adjusting assembly comprises an adjuster and a second control piece, the adjuster is arranged on the outer circumference of the tube body in a matched mode and moves between the near-end direction and the far-end direction of the tube body in the axial direction of the tube body, a traction wire penetrates through the traction hole, and the distance between the traction hole and the outer surface of the tube body is a preset radial distance; after the first control piece applies traction force to the snake bone pipe through the traction wire, the second control piece controls the adjuster to move in the direction close to or away from the snake bone pipe in the axial direction, so that the actual axis of the guide pipe moves towards the preset axis.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically to a guide tube and a delivery system using the guide tube for delivering a heart valve prosthesis. Background Technology

[0002] The heart can develop various valvular diseases due to congenital or acquired causes, which can directly or indirectly harm the physical and mental health of patients. When valvular disease progresses to a severe stage, it is often necessary to replace the diseased natural valve with an artificial valve prosthesis. Currently, percutaneous minimally invasive interventional treatment technology is rapidly developing. This technology allows the valve prosthesis to be inserted into the body through a catheter via blood vessels or other pathways and deployed at the target site to treat valvular diseases. In this process, how to accurately deliver the valve prosthesis to the expected location within the heart via the delivery catheter, and how to rationally utilize anatomical spaces such as the atria for fine-tuning of its position, have become crucial factors affecting the success of the surgery.

[0003] Taking tricuspid valve repair as an example, the tricuspid valve has a complex anatomy, and the delivery catheter must traverse multiple tortuous paths to reach its intended position during interventional surgery. During this process, the catheter's curvature needs to be adjusted to conform to the anatomical orientation. However, the existing design of delivery catheters has limitations; curvature adjustments often cause uncontrollable changes in the overall tubing morphology, leading to deviations in the final positioning of the valve prosthesis from the expected outcome. In some cases, even extreme cardiac dilation is required to obtain sufficient operating space, significantly limiting the applicability and success rate of the procedure. Summary of the Invention

[0004] To address the above technical problems, one aspect of the present invention provides a guide tube, comprising: A tube body having a first lumen extending axially, and a proximal end and a distal end located at both ends of the lumen; A snake-bone tube, located at the distal end of the tube body, has a second lumen; The traction wire has a proximal end and a distal end, the distal end passing through the first lumen and the second lumen and connected to the distal end of the snake-bone tube, and the proximal end connected to a first control element disposed at the proximal end of the tube body; An adjustment assembly includes an adjuster and a second control element. The adjuster is disposed on the tube body and is movable along the axial direction. The adjuster has a traction hole through which the traction wire passes. The traction hole has a geometric center at a predetermined radial distance from the outer surface of the tube body. After the first control element applies a traction force to the snake tube through the traction wire, the second control element adjusts the torque of the distal end of the snake tube relative to the proximal end of the traction wire by changing the axial position of the adjuster, thereby controlling the actual axis of the guide tube to move towards the predetermined axis.

[0005] In some embodiments, the axis of the traction hole on the regulator is parallel to the axis of the tube or at a pre-tilt angle of 2-8 degrees, and the distance d between the inner wall of the traction hole and the outer surface of the tube satisfies: 0.05 mm ≤ d ≤ 2.3 mm.

[0006] In some embodiments, the regulator is sleeved on the outer circumference of the tube body; the regulator is frictionally connected to the outer circumferential surface of the tube body, and the frictional force between them satisfies the following condition: the second control member can drive the regulator to move along the axial direction of the tube body between the proximal and distal directions of the tube body only after overcoming the frictional force; when the frictional force is not reached, the regulator is relatively fixed on the tube body.

[0007] In some implementations, the regulator is a porous tube structure, the porous tube including a main hole for fitting onto the outer surface of the tube body, and the traction hole is arranged around the main hole.

[0008] In some implementations, the traction hole includes a pair of parallel through holes; the porous tube has multiple sets of traction holes arranged evenly around the main hole. It should be noted that the traction hole is not limited to a through hole; it can also be an open traction groove, a protruding traction column, or a pulley structure. As long as it enables the eccentric arrangement of the traction wire and its movement with the adjuster, it is considered an equivalent feature of the through hole in this application.

[0009] In some embodiments, the traction wire is arranged in a direction 180 degrees rotated from the routing direction in the snake-bone tube.

[0010] In other implementations, the connection between the regulator and the tube body employs a magnetic pre-tightening method. Specifically, the regulator and tube body are magnetically attracted by a permanent magnet ring or electromagnetic coil, and the axial force overcomes the magnetic force to move. The regulator is magnetically levitated and positioned around the outer periphery of the tube body. A traveling wave magnetic field capable of generating an axial direction is positioned between the regulator and the tube body. A displacement sensor is installed on the regulator to detect the gap between the regulator and the tube body in real time. A second control component is signal-connected to the regulator to control its stable levitation on the tube body and free sliding along the axial direction.

[0011] It should be noted that the connection method between the regulator and the tube body is not limited to the friction connection and magnetic pre-tightening connection mentioned above. It may also include, but is not limited to, ball bearing sliding (ball bearings are embedded in the main hole of the regulator and cooperate with the spiral groove or straight groove on the surface of the tube body to achieve low-friction and precise movement) or shape locking (the regulator is engaged with the axial groove on the tube body by elastic claws, and the locking is released by pressing the claws). As long as the regulator can move in a controlled manner in the axial direction and remain relatively fixed when the external force is removed, the connection method falls within the protection scope of this application.

[0012] In some embodiments, the tube body of the snake-bone tube includes at least a first tube segment and a second tube segment, which, when the same traction force is applied, form a first curved segment and a second curved segment that bend in opposite directions.

[0013] In some implementations, the snake-bone tube includes a first tube segment, a second tube segment, and a steering unit section; The first pipe section is configured with multiple first unit sections, which bend in the first direction when the traction force is applied to form the first curved section; The second pipe section is configured with multiple second unit sections, which bend in the second direction and form a second curved section when the traction force is applied; The steering unit section is configured in the second pipe section to further adjust the bending direction of the second curved section.

[0014] In some implementations, the snake-bone tube is integrally formed from a single tubular material through laser cutting.

[0015] In some embodiments, the guide tube further includes a hyaluronic acid tube sleeved around the tube body and the snake bone tube; The hysteresis tube is equipped with a stiffening section, a bending section, and a receiving section; The stiffening section is sleeved around the periphery of the tube body; the snake-bone tube is movable in both the bending section and the receiving section; The bending section and the receiving section bend synchronously with the snake-bone tube.

[0016] In some implementations, the tube body of the receiving section is provided with an anti-rotation joint to prevent the hysteresis tube from rotating.

[0017] According to another aspect of this application, a delivery system for delivering a heart valve prosthesis is provided, including a guide tube as described in any of the preceding claims, a control handle, and a pull claw seat for connecting the valve prosthesis. The proximal end of the guide tube is mounted on the control handle, and the first and second control components are coupled to the control handle; the pull claw seat is located on one side of the distal end of the snake tube and can move closer to or further away from the distal end of the snake tube along the axial direction within the tube; the distal end of the pull claw seat is connected to a heart valve prosthesis.

[0018] Compared with the prior art, the guide tube described in this application has the following advantages: it can make maximum use of the right atrial space without changing the implant, so that the valve can reach a favorable position during the release process, and the applicable range is expanded to patients with relatively low atrial height but severe disease. Attached Figure Description

[0019] Figure 1The image shows the effect achieved by adjusting the guide tube of a conventional conveying system on the market; Figure 2 The image shows the effect of a conventional delivery system used for valve replacement. Figure 3 This is a schematic diagram illustrating the structure of an adjusted guide tube according to an embodiment of this application; Figure 4 This is a schematic diagram of the structure of a guide tube according to an embodiment of this application; Figure 5 This diagram illustrates the working principle of the regulator for adjusting the guide tube axis. Figure 6 This is a schematic cross-sectional view of a guide tube and regulator according to an embodiment of this application. Figure 7 This is a schematic cross-sectional view of another guide tube and regulator according to an embodiment of this application; Figure 8 A cross-sectional view of a regulator according to an embodiment of this application. Figure 9 This is a structural development diagram of a snake-bone tube according to an embodiment of this application; Figure 10 This is a structural development diagram of a submersible tube according to an embodiment of this application; Figure 11 This is an enlarged view of a section of a submersible tube according to an embodiment of this application.

[0020] Figure label: 1-Pipe body, 2-Snake bone pipe, 21-First pipe section, 22-Second pipe section, 23-Steering unit section, 3-Traction wire, 4-Adjusting assembly, 40-Adjuster, 41-Main hole, 42-Traction hole, 5-First control component, 6-Second control component, 10-Railway, 101-Slit, 102-Connector, 103-First anti-rotation joint, 104-Second anti-rotation joint. Detailed Implementation

[0021] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0022] It should be understood that the described embodiments are merely some, not all, of the embodiments in this application. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0023] The terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The singular forms “a,” “the,” and “the” used in the embodiments of this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise.

[0024] The terms “bottom,” “top,” “lower,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0025] Unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and 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 invention based on the specific circumstances.

[0026] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly stated. The terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance. The term “or” is generally used to include the meaning of “and / or” unless otherwise expressly stated.

[0027] As used in this article, the proximal end refers to the side closer to the center of the heart (such as the atria or ventricles) or upstream of the blood flow. The distal end refers to the side farther from the center of the heart or downstream of the blood flow. For medical devices, the proximal end refers to the portion closer to the operator or external drive / control end, usually located at the device inlet; the distal end refers to the portion farther from the operator and closer to the target or implantation site, usually located at the device tip. The axial direction refers to an imaginary straight line extending along the main centerline of the device's length, from the proximal end to the distal end.

[0028] Figure 1 The image shows the effect achieved by adjusting the guide pipes of a conventional conveyor system on the market. Figure 1As can be seen, because the outermost part of the guide tube is equipped with a hyaluronic acid tube, and the proximal end and part of the hyaluronic acid tube extending to the distal end are made of a harder material, while the part of the tube near the distal end is made of a softer material, the effect is that only the distal end of the guide tube is bent. Figure 1 The dotted line of the guide tube shown in the figure represents the ideal position reached by the guide tube. After reaching the ideal position, the distal end is bent. The bending of the distal end of the guide tube is controlled by the traction line set in the inner cavity of the guide tube.

[0029] However, since the traction line extends through the entire length of the guide tube's inner cavity, it affects the entire guide tube: the proximal part of the guide tube bends less due to the harder material, but still flexes slightly. This flexing causes the entire guide tube to deflect away from the guide tube's axis, resulting in the guide tube's tip also moving away from the guide tube's axis, thus failing to reach the desired target point.

[0030] Figure 2 The effect of a conventional delivery system on valve replacement (taking the tricuspid valve as an example) is shown. Due to the guide tube tilting to one side of the blood vessel, the final positioning of the valve prosthesis deviates from the expected position. This delivery system has high requirements for atrial and ventricular height, and in some cases, it requires extreme dilation of the patient's heart to obtain sufficient operating space.

[0031] The inventors of this application discovered that by pulling the distal end of the guide tube back towards a pre-set axis line, the tilted guide tube returns to its pre-set axis line, thus adjusting the distal end of the guide tube to... Figure 3 When the valve is in the bent position shown, the position of the right atrium is observed. This approach maximizes the use of right atrial space, allowing the valve to reach a favorable position during deployment. Compared to Figure 2 The conventional delivery system shown in the video has high requirements for atrial and ventricular height. Figure 3 A delivery system that uses adjustment of the distal end of the guide tube to align it significantly reduces the requirements for atrial and ventricular height. Therefore, this system is adopted... Figure 3 The bending method and corresponding adjustment of the guide tube shown can expand the scope of application without changing the implant, making it more suitable for patients with relatively low atrial height but severe disease.

[0032] To achieve the above Figure 3 Regarding the bending method of the guide tube, this application provides a guide tube. Figure 4 This is a schematic diagram of a guide tube according to an embodiment of this application. See also... Figure 4 The guide tube includes a tube body 1, a snake-bone tube 2, a traction wire 3, and an adjustment assembly 4.

[0033] The tube body 1 has a first lumen extending axially, and proximal and distal ends located at both ends of the lumen. The snake-bone tube 2 is disposed at the distal end of the tube body 1 and has a second lumen. The tube body 1 of the snake-bone tube 2 includes at least a first segment and a second segment (see [reference]). Figure 8 The snake-bone tube shown forms a first and second curved section that bend in opposite directions when the same traction force is applied (see [reference]). Figure 5 (Example in the text). The traction wire 3 has a proximal end and a distal end. The distal end passes through the first lumen and the second lumen and connects to the distal end of the first tube segment. The proximal end is connected to the first control member 5 disposed at the proximal end of the tube body 1. The adjustment assembly 4 includes an adjuster 40 and a second control member 6. The adjuster 40 is disposed on the tube body 1 and is axially movable. The adjuster 40 is provided with a traction hole through which the traction wire 3 passes. The traction hole has a geometric center at a predetermined radial distance from the outer surface of the tube body 1. After the first control member applies traction force to the snake tube 2 through the traction wire 3, the second control member adjusts the torque of the distal end of the snake tube relative to the proximal end of the traction wire by changing the axial position of the adjuster 40, so as to control the actual axis of the guide tube to move towards the predetermined axis, that is, to make the guide tube return from the actual axis to the predetermined axis.

[0034] When the actual centerline of the guide tube (see guide tube position) Figure 1 The actual position of the guide tube (the axis of the guide tube when it is in its center) and the predetermined axis of the guide tube (see the guide tube in its center position). Figure 1 When the position of the dashed line (where the guide tube's axis is located) deflects, the position of the adjuster 10 in the axial direction can be adjusted, thereby adjusting the torque of the distal end of the snake tube relative to the proximal end of the traction wire. After the first control element applies traction force to the snake tube through the traction wire, the two ends of the traction wire, the proximal and distal ends, are essentially temporarily fixed. When the adjuster 10 is close to the proximal side of the tube body, the torque applied by the adjuster 10 to the distal end of the snake tube relative to the proximal end of the traction wire is small. As the adjuster 10 moves axially towards the distal end, the torque applied by the adjuster 10 to the distal end of the snake tube relative to the proximal end of the traction wire gradually increases. Correspondingly, the traction force that pulls the guide tube towards the predetermined axis increases, and the distal end of the tube body 1 moves towards the side of the predetermined axis of the guide tube, thereby making the actual axis of the guide tube coincide with the predetermined axis, overcoming the deflection of the actual axis relative to the predetermined axis.

[0035] See Figure 5 This shows a schematic diagram illustrating the working principle of the regulator 40 for adjusting the centerline of the guide tube.

[0036] Figure 5In diagram a, the snake-bone tube 2 is not yet pulled by the traction wire 3 and is in a straight state. The total length of the traction wire 3 within the guide tube is a+b, and the predetermined axis of the guide tube is Ф0. Ф0 can be considered as the theoretical interventional path of the guide tube within the blood vessel. It should be noted that the straight line in the diagram is only for illustrative purposes; in actual use, Ф0 may also be inclined or not a completely straight line.

[0037] After the first control element applies traction force to the snake-bone tube 2 via the traction wire 3, the snake-bone tube 2 bends. Because the traction wire extends through the entire length of the tube body 1 and the snake-bone tube 2, the proximal section of the tube body 1, made of a harder material, bends less, but still exhibits slight deflection, as shown in the image. Figure 5 The tilt shown in figure b indicates that the guide tube section 1 and the snake-bone tube 2 are tilted relative to the predetermined axis Ф0 (the position of Ф0 has been shifted by a certain distance in the figure for clarity), meaning the actual axis is Ф1. This causes the head end of the guide tube to not reach the desired target point. When the snake-bone tube 2 bends to the preset angle, the first control unit locks the movement of the traction wire 3, and the two endpoints A and B of the proximal and distal ends of the traction wire are temporarily fixed. At this time, the total length of the traction wire 3 in the guide tube is a1 + b1, where a1 + b1 < a + b.

[0038] After the first control element locks the movement of the traction wire 3, the adjuster 40 is provided with a traction hole through which the traction wire 3 passes. The traction hole has a geometric center at a predetermined radial distance from the outer surface of the tube body 1, which makes the traction wire 3 form as follows: Figure 5 The state shown in c.

[0039] The regulator 40 is disposed on the outer circumference of the tube body 1 and moves along the axial direction of the tube body 1 between the proximal and distal directions under the control of the second control element.

[0040] Torque can be divided into the moment of a force about an axis and the moment of a force about a point. The moment of a force about an axis is the physical quantity that causes a force to rotate an object about a certain axis. The moment of a force about a point is the physical quantity that causes a force to rotate an object about a specific point. It is a vector quantity, equal to the vector product of the force's action r (position vector at the point) and F (force vector). Figure 5 In equation c, the proximal end B of the traction wire is fixed at point O. The position vector from point O to the point A where F acts is r, and the angle between r and F is α1. The magnitude of the rotational action of the distal end A of the traction wire and the direction of the axis of rotation depend on the moment vector M of F about point O, M = rFsina.

[0041] The second control unit controls the regulator 40 to move to the position as follows: Figure 5At position d, the angle between r and F is α2. α2 > α1. Therefore, as the regulator 40 gradually moves towards the distal end of the tube, the torque applied by the regulator 10 to the distal end of the snake-bone tube relative to the proximal end of the traction wire gradually increases. This means the rotational effect of the regulator on the distal end A of the traction wire becomes stronger, thus pulling the distal end of the guide tube towards the side of the predetermined axis of the guide tube, gradually aligning the actual axis of the guide tube with the predetermined axis, achieving the realignment of the guide tube's actual axis. The position of the guide tube relative to the predetermined axis Ф0 is shown in [reference needed]. Figure 5 e.

[0042] As can be seen from the above technical solution, in order to adjust the deflection of the guide tube relative to the predetermined axis, an adjuster that can reciprocate along the axial direction of the guide tube is provided inside the guide tube. The adjuster has a traction hole through which the traction wire (used to pull the snake tube) can pass, and the traction hole ensures a predetermined radial distance between the traction wire and the outer surface of the tube body. When the traction wire pulls the snake tube to a position where it is deflected, the adjuster is moved closer to the distal end. The second control component adjusts the torque of the distal end of the snake tube relative to the proximal end of the traction wire by changing the axial position of the adjuster, thereby correcting the actual axis of the guide tube back to the predetermined axis. Therefore, this application can maximize the use of the right atrial space without changing the implant, allowing the valve to reach a favorable position during release, and expanding the applicable range to patients with relatively low atrial height but severe disease.

[0043] In one embodiment, the adjuster 40 is fitted onto the outer circumference of the tube body 1. The adjuster 40 is in frictional contact with the outer circumferential surface of the tube body 1, and the frictional force between them satisfies the following condition: the second control member must overcome the frictional force to drive the adjuster 40 to move along the axial direction of the tube body 1 between the proximal and distal ends; when the frictional force is not reached, the adjuster 40 is relatively fixed on the tube body 1. By fitting the adjuster 40 onto the outer circumference of the tube body 1 and forming a frictional connection with the outer surface of the tube body 1, the adjuster 40 can remain relatively fixed when not subjected to sufficient driving force, thereby stably maintaining the bending shape of the snake-bone tube 2 after the bending operation; while when the second control member applies a driving force to overcome the frictional force, the adjuster 40 can move smoothly along the axial direction, achieving precise adjustment of the position of the second bending segment.

[0044] The regulator 40 is directly fitted onto the outer circumference, eliminating the need for additional guide grooves or nested cannulas inside the catheter wall and avoiding an increase in the catheter's outer diameter. For percutaneous interventional procedures, minimizing the catheter's outer diameter reduces the risk of vascular puncture injury and hemodynamic disturbances, which is particularly significant in stenotic or tortuous pathways such as the aorta, atrium, and tricuspid valve. The frictional connection between the regulator 40 and the outer circumferential surface of the tube body 1 provides a passive locking characteristic: when no sufficient external force is applied, the regulator 40 remains fixed relative to the tube body 1, ensuring the stability of the bent shape after adjustment and preventing changes due to blood flow or slight catheter vibrations. When readjustment of the bend position is required, the second control component applies a driving force sufficient to overcome friction, causing the regulator 40 to move smoothly axially, altering the force distribution of the traction wire 3 within the second lumen, thereby precisely adjusting the position of the second bend of the snake-like tube 2. This adjustable friction mechanism is equivalent to a built-in "clutch" effect, simplifying the mechanical structure while improving the reliability of intraoperative procedures.

[0045] In some other possible implementations Figure 6 The diagram shows a cross-sectional structure of a guide tube and regulator 40 according to an embodiment of this application. See also... Figure 6 A track 10 is provided on the outer circumference of the tube body 1. An adjuster 40 is slidably connected to the track. The adjuster 40 is provided with a traction hole 42 through which the traction wire 3 passes and at a predetermined radial distance from the outer circumference of the tube body 1. In some embodiments, the track may be a strip-shaped protrusion provided on the tube body 1, extending axially from the proximal end of the tube body 1 to the distal end. In other embodiments, the strip-shaped protrusion may be integrally formed with the tube body 1. It should be noted that this application does not specifically limit the cross-sectional shape of the strip-shaped protrusion, such as circular, elliptical, inverted triangular, etc. Any cross-sectional shape that can engage the adjuster 40 on the strip-shaped protrusion and allow the adjuster 40 to slide back and forth axially from the proximal end to the distal end of the tube body 1 falls within the protection scope of this application.

[0046] In some other possible implementations, the regulator is magnetically levitated and disposed on the periphery of the tube body. Figure 7 For a schematic cross-sectional view of another guide tube and regulator according to an embodiment of this application, see [link to relevant documentation]. Figure 7The stator of a linear motor can be embedded inside the tube (e.g., using a slotless, coreless linear motor structure with the windings installed inside the tube, not shown in the figure), and a permanent magnet or coil can be installed inside the regulator as the mover. By controlling the current in the stator coil, a traveling wave magnetic field along the direction of the tube is generated, which interacts with the permanent magnet inside the regulator to achieve magnetic levitation and linear motion. Simultaneously, in the radial direction, levitation force is generated by arranging multiple sets of electromagnets or using a Halbach array of permanent magnets. This, combined with displacement sensors (such as laser or capacitive sensors) to detect the gap between the regulator and the tube in real time, forms a closed-loop control, ensuring that the regulator is stably suspended on the tube and can slide freely.

[0047] In one embodiment, the axis of the traction hole on the regulator is parallel to the axis of the tube body, see [reference needed]. Figure 5 c or Figure 5 The dashed line shown on the regulator is d. The distance d between the inner wall of the traction hole and the outer surface of the tube can be considered as the actual or virtual wall thickness between the regulator and the outer surface of the tube (the gap when the regulator is magnetically levitated around the outer periphery of the tube). This wall thickness satisfies: 0.05mm ≤ d ≤ 2.3mm. Using this range of wall thickness ensures that the actual axis of the guide tube coincides with the predetermined axis when the regulator moves axially to the distal end of the tube. This range also allows for a smaller overall outer diameter of the guide tube, making it suitable for catheter-based interventional treatment scenarios.

[0048] In other implementations, the axis of the traction hole is pre-tilted at an angle of 2-8 degrees to the axis of the tube body. When the axis of the traction hole is slightly tilted relative to the axis of the tube body, the distance between the distal and proximal ends of the inner wall of the traction hole and the outer surface of the tube body also satisfies: 0.05 mm ≤ d ≤ 2.3 mm.

[0049] In some implementations, the regulator 40 is a porous tube structure. Figure 8 See also a cross-sectional view of a regulator 40 according to an embodiment of this application. Figure 8 The multi-hole tube includes a main hole 41 for fitting around the outer circumference of the tube body 1, and a traction hole 42 located around the main hole. The main hole of the multi-hole tube serves the functions of fitting and positioning, and its inner diameter matches the outer diameter of the tube body 1 of the delivery conduit, achieving a stable fit through interference or friction connection. The traction hole 42 is located around the main hole and is specifically used to thread and fix the traction wire 3, ensuring that the traction wire 3 maintains its relative position during adjustment and does not slip or deviate as the adjuster 40 moves. This functional separation avoids stress concentration or hole interference problems caused by a single lumen having to bear both the fitting friction and the arrangement of the traction hole 42.

[0050] See also Figure 8The traction hole 42 includes a pair of parallel through holes. Multiple sets of traction holes 42 are arranged on the tube body 1 of the multi-hole tube, evenly arrayed around the main hole. In interventional delivery catheters, the traction wire 3 typically needs to withstand significant tensile force and must maintain a stable position during adjustment. Using a pair of parallel through holes as a set of traction holes 42 allows two traction wires 3 to be threaded through the same set of holes, forming two independent mechanical paths and preventing entanglement of the traction wires 3. The design of multiple sets of traction holes 42 provides independent traction paths for different bending sections or different adjustment modes, avoiding mutual interference. Multiple sets of holes allow for multiple position selections of the traction wire 3 and also reserve space for future functional upgrades (such as adding sensor wires or auxiliary traction cables).

[0051] The traction wire 3 is routed at an angle of 150-210 degrees relative to its route in the regulator 40, to achieve a reversal of the tension direction, causing the corresponding section of the snake tube to deflect in a predetermined direction when the regulator moves to the distal end. In some feasible embodiments, the traction wire 3 is arranged at a 180-degree angle relative to its route in the regulator 40, as shown in [reference needed]. Figure 4 , Figure 5 a, Figure 5 b and Figure 5 e. In the bending mechanism, the direction of tension of the traction wire 3 directly affects the bending shape of the snake tube 2. When the traction wire 3 runs in a 180° reverse direction within the adjuster 40, it forms an "S"-shaped path. The direction of tension entering the snake tube 2 is exactly opposite to its direction of tension within the adjuster 40. Thus, when the adjuster 40 moves, the corresponding section of the snake tube 2 will exhibit a bending tendency coordinated with the direction of movement, forming a closed-loop force-displacement control. This rotational arrangement avoids excessive local bending caused by unidirectional tension, resulting in a more uniform stress distribution and extending the life of the traction wire 3.

[0052] In some embodiments, the two segments in the snake-bone tube are configured as a first curved segment and a second curved segment that bend in opposite directions. The first curved segment is used to bend toward a desired target point, and the second curved segment bends in the opposite direction to the first curved segment. Figure 9 This is a structural development diagram of a snake-bone tube according to an embodiment of this application. See also... Figure 9The snake-bone tube 22 includes a first tube segment 21, a second tube segment 22, and a steering unit section 23. The steering unit section 23 is used to steer the second tube segment 22 in the opposite direction to the first tube segment 21. The first tube segment 21 is equipped with multiple first unit sections, which bend in a first direction and form a first curved section when traction is applied. The second tube segment 22 is equipped with multiple second unit sections, which bend in a second direction and form a second curved section when traction is applied. The steering unit section 23 is located in the second tube segment 22 and is used to further adjust the bending direction of the second curved section. A mounting unit section 24 is also provided at the distal end of the first tube segment 21, which has a mounting hole for connecting and fixing the traction wire 3, or for threading the traction wire 3. A connecting unit 25 is provided at the proximal end of the second tube segment 22 for fixed connection with the tube body 1. In this embodiment, the structure of the snake-bone tube 2 is designed to enable the first tube segment 21 and the second tube segment 22 to simultaneously form a first curved segment and a second curved segment that are bent in opposite directions when the same traction force is applied.

[0053] In one embodiment, the tube body of the snake bone tube 2 is integrally formed from a single tubular material through laser cutting.

[0054] It should be noted that this application does not specifically limit the bending structure of the first pipe segment 21 and the second pipe segment 22. Any structure that enables the first pipe segment 21 and the second pipe segment 22 to bend in the predetermined bending direction and in the opposite direction falls within the protection scope of this application.

[0055] In one embodiment, the guide tube further includes a hyaluronic acid tube sleeved around the tube body 1 and the snake bone tube 2. Figure 10 This is a structural development diagram of a submersible tube according to an embodiment of this application. See also... Figure 10 The sodium hypochlorite tube 7 is provided with a stiffening section 71, a bending section 72, and a retraction section 73. The stiffening section 71 is sleeved on the periphery of the tube body 1. The serpentine tube 2 can move in both the bending section 72 and the retraction section 73, and the bending section 72 and the retraction section 73 bend synchronously with the serpentine tube 2. In this application, the sodium hypochlorite tube can maintain synchronous bending with the serpentine tube.

[0056] In this scheme, the traction wire 3 applies tension through the adjuster 40, causing the second bending section of the snake tube 2 to bend. The bending of the snake tube 2 not only changes its own axial orientation but also causes the surrounding submersible tubes to bend synchronously (the bending section and the inlet section). If the submersible tube rotates around its axis during bending, the relative position of the traction wire 3 at the inlet of the snake tube 2 will change, thus affecting the linear relationship between the tension direction and the bending effect, and even leading to uncontrolled bending or asymmetrical bending. In one feasible scheme, an anti-rotation joint is provided in the tube body 1 of the inlet section to prevent rotation of the submersible tube body 1. Figure 11This is an enlarged view of a section of a submersible tube according to an embodiment of this application. See also... Figure 11 The tube body of the sodium hypochlorite includes a slit 101, a connector 102, a first anti-rotation joint 103, and a second anti-rotation joint 104. Both the first anti-rotation joint 103 and the second anti-rotation joint 104 are T-shaped keys extending from the connector 102. Corresponding to the first anti-rotation joint 103 and the second anti-rotation joint 104 are keyways formed on the connector 102. The T-shaped keys and keyways are interlocked, and the T-shaped keys of the first anti-rotation joint 103 and the second anti-rotation joint 104 are oriented oppositely in the axial direction. The above arrangement restricts the sodium hypochlorite in the circumferential direction, allowing it to move only axially and bend with the serpentine tube 2, but preventing it from rotating freely.

[0057] The anti-rotation joint ensures that the routing relationship of the traction wire 3 between the snake tube 2 and the regulator 40 remains constant during the bending process, preventing circumferential displacement of the traction wire 3 outlet position due to the rotation of the thallium tube, thus maintaining a stable tension direction and ensuring a predictable linear relationship between the position adjustment of the second bending section and the bending angle. The anti-rotation joint effectively suppresses unexpected torsion during the bending process, improving system stability and repeatability.

[0058] According to another aspect of this application, a delivery system for delivering a heart valve prosthesis is also provided, the structure of which can be referred to Figure 2 or Figure 3 The delivery system includes a control handle, a guide tube as shown in the embodiments above, and a puller seat for connecting the valve prosthesis. The proximal end of the guide tube is mounted on the control handle, and a first control element and a second control element are coupled to the control handle. The first and second control elements may be knob structures sleeved on the control handle, or dial structures disposed on the side of the control handle, etc. This application does not specifically limit the structural form of the control elements and the coupling method with the control handle. The puller seat is located on one side of the distal end of the snake tube 2 and can be axially approached or moved away from the distal end of the snake tube 2 within the tube body 1; the distal end of the puller seat is connected to the heart valve prosthesis.

[0059] As can be seen from the above technical solutions, the delivery system disclosed in this application can make maximum use of the right atrial space during percutaneous minimally invasive interventional treatment, so that the heart valve prosthesis can reach a favorable position during the release process.

[0060] Obviously, many modifications and variations can be made based on the content of this specification. These embodiments have been selected and specifically described in this specification to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to make good use of the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A guide tube, characterized in that, include: A tube body having a first lumen extending axially, and a proximal end and a distal end located at both ends of the lumen; A snake-bone tube, located at the distal end of the tube body, has a second lumen; The traction wire has a proximal end and a distal end, the distal end passing through the first lumen and the second lumen and connected to the distal end of the snake-bone tube, and the proximal end connected to a first control element disposed at the proximal end of the tube body; An adjustment assembly includes an adjuster and a second control element. The adjuster is disposed on the tube body and movable along the axial direction. The adjuster has a traction hole through which the traction wire passes. The traction hole has a geometric center at a predetermined radial distance from the outer surface of the tube body. After the first control element applies a traction force to the snake tube through the traction wire, the second control element adjusts the torque of the distal end of the snake tube relative to the proximal end of the traction wire by changing the position of the adjuster in the axial direction, thereby controlling the actual axis of the guide tube to move towards the predetermined axis.

2. The guide tube according to claim 1, characterized in that, The axis of the traction hole on the regulator is parallel to the axis of the tube or at a pre-tilt angle of 2-8 degrees, and the distance d between the inner wall of the traction hole and the outer surface of the tube satisfies: 0.05 mm ≤ d ≤ 2.3 mm.

3. The guide tube according to claim 1, characterized in that, The traction wire rotates within a range of 150-210 degrees from the routing direction of the snake-bone tube to the routing direction of the traction hole.

4. The guide tube according to any one of claims 1 to 3, characterized in that, The regulator is a porous tube structure, the porous tube includes a main hole for fitting onto the outer surface of the tube body, and the traction hole is arranged around the main hole.

5. The guide tube according to claim 4, characterized in that, The regulator is fitted onto the outer circumference of the tube body; the regulator is in frictional connection with the outer circumferential surface of the tube body, and the frictional force between them satisfies the following condition: the second control component can drive the regulator to move along the axial direction of the tube body between the proximal and distal ends of the tube body only after overcoming the frictional force; when the frictional force is not reached, the regulator is relatively fixed on the tube body.

6. The guide tube according to claim 4, characterized in that, The regulator is magnetically levitated and disposed on the outer periphery of the tube body; a traveling wave magnetic field capable of generating an axial direction is configured between the regulator and the tube body; a displacement sensor for real-time detection of the gap between the regulator and the tube body is provided on the regulator; a second control component is signal-connected to the regulator to control the regulator to stably levitate on the tube body and slide freely along the axial direction.

7. The guide tube according to claim 4, characterized in that, The snake-bone tube includes a first tube segment, a second tube segment, and a steering unit section; The first pipe section is equipped with multiple first unit sections, which bend in the first direction and form a first curved section when the traction force is applied. The second pipe section is configured with multiple second unit sections, which bend in the second direction and form a second curved section when the traction force is applied; The steering unit section is configured in the second pipe section to further adjust the bending direction of the second curved section.

8. The guide tube according to claim 4, characterized in that, It also includes a hyaluronic acid tube sleeved around the tube body and the snake bone tube; The hysteresis tube is equipped with a stiffening section, a bending section, and a receiving section; The stiffening section is sleeved around the periphery of the tube body; the snake-bone tube is movable in both the bending section and the receiving section; The bending section and the receiving section bend synchronously with the snake-bone tube.

9. The guide tube according to claim 8, characterized in that, The tube body of the receiving section is provided with an anti-rotation joint to prevent the hysteresis tube from rotating.

10. A delivery system for delivering a prosthetic heart valve, characterized in that, It includes a guide tube, a control handle, and a puller for connecting a valve prosthesis, as described in any one of claims 1-9. The proximal end of the guide tube is mounted on the control handle, and the first control element and the second control element are coupled to the control handle. The pull claw seat is located on one side of the distal end of the snake bone tube and can move closer to or further away from the distal end of the snake bone tube along the axial direction within the tube; the distal end of the pull claw seat is connected to a heart valve prosthesis.

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