Delivery System

Abstract

The present application relates to a delivery system in which an inner catheter (2000) is movably disposed within an axial lumen of an outer catheter (1000). The inner catheter (2000) has a pushing inner catheter section (1100) and a curved inner catheter section (1200) along its axial direction. The diameter of the curved inner catheter section (1200) is larger than the diameter of the pushing inner catheter section (1100). A guidewire (2100b) is inserted into the guide lumen of the inner catheter (2000), and a puller wire (2200b) is connected to the curved inner catheter section (1200).

Description

[Technical Field]

[0001] This application claims priority to Chinese Patent Application No. 2022115276593, filed on December 1, 2022, entitled "Delivery System," the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] TECHNICAL FIELD This application relates to the field of medical devices, and more particularly to delivery systems.

[0003] Transcatheter aortic valve replacement (TAVR) is a procedure in which a prosthetic aortic valve is delivered to the aortic root using a catheter delivery system, secured in place, and released to replace the native valve. TAVR is a widely adopted technique in the field of valvular heart disease treatment and represents a breakthrough in minimally invasive treatment of aortic valve disease. Treating aortic valve disease with TAVR does not require opening the patient's chest or stopping the heart, so it is less traumatic for the patient.

[0004] Most catheters in existing delivery systems used in TAVR procedures cannot be actively steered. To pass through the aortic arch, they must be passively bent by the reaction force from the vessel wall. However, this process can cause some damage to the vessel wall, potentially leading to vascular complications. Furthermore, the inability of such catheters to be actively steered makes crossing the annulus and coaxial release in later TAVR stages extremely difficult, affecting valve release and anchoring. Therefore, how to achieve active steerability in delivery system catheters remains a challenging problem that requires urgent resolution. Summary of the Invention

[0005] A delivery system is proposed in various embodiments disclosed herein, including: an outer catheter having an axial lumen; an inner catheter having a guide lumen, the inner catheter being movably disposed within the axial lumen of the outer catheter, the inner catheter having a pushing inner catheter section and a curved inner catheter section along the axial direction, the distal end of the pushing inner catheter section being connected to the proximal end of the curved inner catheter section, the curved inner catheter section having a diameter larger than that of the pushing inner catheter section; a guide wire inserted into the guide lumen of the inner catheter; and a puller wire connected to the curved inner catheter section.

[0006] In one embodiment, the distal end of the puller wire is connected to the distal end of the curved inner catheter section.

[0007] In one embodiment, the curved inner catheter section is provided with a traction anchor, and the puller wire is connected to the curved inner catheter section via the traction anchor.

[0008] In one embodiment, the traction fixation member has a first lumen in communication with the guide lumen.

[0009] In one embodiment, the traction fixation member is provided with a first wire attachment member, and the traction wire is connected to the first wire attachment member.

[0010] In one embodiment, the inner catheter has a traction lumen and the puller wire is inserted within the traction lumen of the inner catheter.

[0011] In one embodiment, the traction lumen includes a bow-resistant support tube within it.

[0012] In one embodiment, the proximal end of the pushing inner catheter section is provided with an inner catheter connecting segment, the inner catheter connecting segment is provided with a wire pull-out port, the wire pull-out port is in communication with the pull-out lumen, and the proximal end of the pull-out wire is pulled out from the wire pull-out port.

[0013] In one embodiment, the proximal end of the curved inner catheter section has a changing diameter segment connected to the distal end of the pressed inner catheter section, the diameter of the changing diameter segment of the curved inner catheter section gradually decreasing from the distal end to the proximal end.

[0014] In one embodiment, the curved inner catheter section is provided with a stent fixation member.

[0015] In one embodiment, the stent fixing member is provided at the proximal end of the curved inner catheter section, and the curved inner catheter section is connected to the distal end of the pressed inner catheter section via the stent fixing member.

[0016] In one embodiment, the stent fixation member is located at the distal end of the curved inner catheter section.

[0017] In one embodiment, the curved inner catheter section has a first inner catheter segment and a second inner catheter segment along the axial direction, and the distal end of the first inner catheter segment is connected to the proximal end of the second inner catheter segment via the stent fixing member.

[0018] In one embodiment, the stent fixation member has a second lumen communicating with the guide lumen.

[0019] In one embodiment, the stent fixation member comprises a stent fixation element.

[0020] In one embodiment, the curved inner catheter section comprises a bendable backbone and a bendable protective layer, the bendable backbone being disposed within the bendable protective layer.

[0021] In one embodiment, the flexible backbone comprises a backbone tube with a wall of the backbone tube having a curved auxiliary opening.

[0022] In one embodiment, the curved auxiliary opening is a linear opening, the curved auxiliary opening is arranged in the circumferential direction of the backbone tube, there are a plurality of the curved auxiliary openings, and the plurality of curved auxiliary openings are distributed along the axial direction of the backbone tube.

[0023] In one embodiment, the bendable protective layer includes a bendable inner protective layer and a bendable outer protective layer, the bendable outer protective layer being provided on the outer surface of the backbone tube, and the bendable inner protective layer being provided on the inner surface of the backbone tube.

[0024] In one embodiment, the flexible backbone includes a plurality of rotatable elements distributed along an axial direction of the flexible backbone, with adjacent rotatable elements being articulated.

[0025] In one embodiment, adjacent rotatable elements are rotatably coupled to a fixed axis, and the rotation axes of the rotatable elements are parallel.

[0026] In one embodiment, the pressed inner catheter section has an inner catheter inner layer and an inner catheter outer layer, an inner catheter braided layer is disposed between the inner catheter inner layer and the inner catheter outer layer, and at least one of the guide lumen and the traction lumen is formed within the inner catheter inner layer.

[0027] In one embodiment, at least one inner catheter reinforcing element is disposed within the inner catheter lining and is positioned between the guide lumen and the traction lumen.

[0028] In one embodiment, the outer catheter has a pressed outer catheter section and a curved outer catheter section along its axial direction, and the distal end of the pressed outer catheter section is connected to the proximal end of the curved outer catheter section.

[0029] In one embodiment, the distal end of the curved outer catheter section has a variable shape segment including a straight cylindrical configuration and a tapered cylindrical configuration, the variable shape segment configured to change between the straight cylindrical configuration and the tapered cylindrical configuration.

[0030] In one embodiment, the proximal end of the curved outer catheter section has a changing diameter segment connected to the distal end of the pressed outer catheter section, the diameter of the changing diameter segment of the curved outer catheter section gradually decreasing from the distal end to the proximal end.

[0031] The details of one or more embodiments of the present application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the present disclosure will become apparent from the description and drawings, and from the appended claims. [Brief explanation of the drawings]

[0032] In order to more clearly explain the technology proposed in this specification or the prior art, the accompanying drawings, which are referred to in connection with the following description of the embodiments or the description of the prior art, are described below. Obviously, these drawings only show some embodiments of the present application, and those skilled in the art can obtain other drawings in light of the drawings included in this specification without exerting creative efforts. [Figure 1] 10A-10C illustrate schematic diagrams of how an inner catheter is steered according to some embodiments of the present application. [Figure 2] 1 is a schematic diagram illustrating the structure of an outer catheter according to some embodiments of the present application. [Figure 3]1 is a schematic diagram illustrating the structure of a delivery system according to some embodiments of the present application. [Figure 4] 1 is a schematic diagram illustrating the structure of a curved outer catheter section according to some embodiments of the present application. [Figure 5] FIG. 5 is an enlarged partial view (I) of the curved outer catheter section of FIG. 4. [Figure 6] 5 is another enlarged partial view (II) of the curved outer catheter section of FIG. 4. [Figure 7] 1 is a schematic diagram illustrating the structure of a backbone tube according to some embodiments of the present application. [Figure 8] FIG. 10 is a schematic diagram showing the structure of a backbone tube according to another embodiment of the present application. [Figure 9] 1 is a schematic cross-sectional view of a pushing inner catheter section according to some embodiments of the present application. [Figure 10] 1 is a schematic diagram illustrating the structure of an inner catheter connection segment according to some embodiments of the present application. [Figure 11] 1 is a schematic diagram illustrating the structure of an inner catheter according to some embodiments of the present application. [Figure 12] FIG. 12 is a schematic diagram of the inner catheter of FIG. 11 in a bent configuration. [Figure 13] 1A and 1B are schematic diagrams illustrating the structure of a traction fixation member according to some embodiments of the present application. [Figure 14] 1A and 1B are schematic diagrams illustrating the structure of a stent fixing member according to some embodiments of the present application. [Figure 15] 1 is a schematic perspective view of an assembly of a traction fixation member, a backbone tube, and a stent fixation member according to some embodiments of the present application. [Figure 16] 1 shows a schematic plan view of an assembly of a traction fixation member, a backbone tube, and a stent fixation member according to some embodiments of the present application. [Figure 17] 10A-10C illustrate a schematic diagram of the operation of a delivery system according to some embodiments of the present application. [Figure 18]10A-10C illustrate a schematic diagram of the operation of a delivery system according to some embodiments of the present application. [Figure 19] 10A-10C illustrate a schematic diagram of the operation of a delivery system according to some embodiments of the present application. [Figure 20] 10A-10C illustrate a schematic diagram of the operation of a delivery system according to some embodiments of the present application. [Figure 21] 10A-10C illustrate a schematic diagram of the operation of a delivery system according to some embodiments of the present application. [Figure 22] 10A-10C are schematic diagrams illustrating the structure of an inner catheter according to some other embodiments of the present application. [Figure 23] FIG. 23 is a schematic diagram of the inner catheter of FIG. 22 in a bent configuration. [Figure 24] 10 shows a schematic perspective view of an assembly of a traction fixation member, a backbone tube, and a stent fixation member according to some other embodiments of the present application. [Figure 25] 10A-10C show schematic plan views of an assembly of a traction fixation member, a backbone tube, and a stent fixation member according to some other embodiments of the present application. [Figure 26] 10A-10C are schematic illustrations of the operation of a delivery system according to some other embodiments of the present application. [Figure 27] 10A-10C are schematic illustrations of the operation of a delivery system according to some other embodiments of the present application. [Figure 28] 10A-10C are schematic illustrations of the operation of a delivery system according to some other embodiments of the present application. [Figure 29] 10A-10C are schematic illustrations of the operation of a delivery system according to some other embodiments of the present application. [Figure 30] 10A and 10B are schematic diagrams illustrating the structure of an inner catheter according to further some embodiments of the present application. [Figure 31] FIG. 31 is a schematic diagram showing the inner catheter of FIG. 30 in a bent configuration. [Figure 32] 10A and 10B are schematic diagrams illustrating the structure of a stent fixing member according to some other embodiments of the present application. [Figure 33]10 shows a schematic perspective view of an assembly of a traction fixation member, a backbone tube, and a stent fixation member according to still other embodiments of the present application. [Figure 34] 10A and 10B show schematic plan views of an assembly of a traction fixation member, a backbone tube, and a stent fixation member according to still other embodiments of the present application. [Figure 35] 1A-1C are schematic illustrations of the operation of a delivery system according to some embodiments of the present application; [Figure 36] 1A-1C are schematic illustrations of the operation of a delivery system according to some embodiments of the present application; [Figure 37] 1A-1C are schematic illustrations of the operation of a delivery system according to some embodiments of the present application; [Figure 38] 1A-1C are schematic illustrations of the operation of a delivery system according to some embodiments of the present application; DETAILED DESCRIPTION OF THE INVENTION

[0033] The embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings. It should be understood that the embodiments described herein are only a part, not all, of the possible embodiments of the present application. In light of the disclosed embodiments, all other embodiments that can be devised by those skilled in the art without requiring creative efforts are also considered to fall within the scope of protection of the present application.

[0034] To more clearly describe the structure of the proposed delivery system, the term "distal end" may be used herein to refer to the end away from the surgeon during a surgical procedure, and the term "proximal end" may be used herein to refer to the end closer to the surgeon during a surgical procedure. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0035] 1 to 3, an embodiment of the present application provides a delivery system including an outer catheter 1000, an inner catheter 2000, a guidewire 2100b, and a puller wire 2200b. The outer catheter 1000 has an axial lumen, and the inner catheter 2000 has a guide lumen 2100a. The inner catheter 2000 is movably disposed within the axial lumen of the outer catheter 1000. The inner catheter 2000 has, along its axial direction, a pushing inner catheter section 2100 and a curved inner catheter section 2200, the distal end of the pushing inner catheter section 2100 being connected to the proximal end of the curved inner catheter section 2200. The diameter of the curved inner catheter section 2200 is larger than the diameter of the pushing inner catheter section 2100. A guidewire 2100b is inserted into the guide lumen 2100a of the inner catheter 2000 and a puller wire 2200b is connected to the curved inner catheter section 2200.

[0036] The phrase "the inner catheter 2000 is movably disposed within the axial lumen of the outer catheter 1000" essentially means that the inner catheter 2000 can move axially and rotate circumferentially within the axial lumen of the outer catheter 1000 relative to the outer catheter 1000. The stent body D with the valve C can be disposed between the inner catheter 2000 and the outer catheter 1000, or can be disposed in the curved inner catheter section 2200 of the inner catheter 2000. In one embodiment, the outer catheter 1000 has an axially pressing outer catheter section 1100 and a curved outer catheter section 1200, and the distal end of the pressing outer catheter section 1100 can be connected to the proximal end of the curved outer catheter section 1200. In this case, the pressing outer catheter section 1100 of the outer catheter 1000 can be structurally identical to the pressing inner catheter section 2100 of the inner catheter 2000. The curved outer catheter section 1200 of the outer catheter 1000 can be structurally corresponding and matched to the curved inner catheter section 2200 of the inner catheter 2000. The length of the curved outer catheter section 1200 can be adjusted based on the curve control requirements. A stent body D with a valve C can be disposed between the curved inner catheter section 2200 of the inner catheter 2000 and the curved outer catheter section 1200 of the outer catheter 1000.

[0037] Continuing to refer to FIG. 1 , the connection position between the puller wire 2200b and the curved inner catheter section 2200 is determined, and when the puller wire 2200b is retracted, the curved inner catheter section 2200 is pulled at that position. That is, when a force F is applied, the puller wire 2200b bends the curved inner catheter section 2200. Because the diameter of the curved inner catheter section 2200 is larger than the diameter of the pressed inner catheter section 2100, pulling the large-diameter curved inner catheter section 2200 via the puller wire 2200b generates a relatively large moment perpendicular to the cross section of the curved inner catheter section 2200, thereby achieving good bending control. That is, by increasing the outer diameter of the curved inner catheter section 2200 and decreasing the elastic modulus of the curved inner catheter section 2200, the inner catheter 2200 can be imparted with a large bending angle.

[0038] To accommodate variable diameter bending control of the inner catheter 2000, the curved outer catheter section 1200 can be designed with an extended length to provide more space without being limited to the present application. Furthermore, the puller wire 2200b can be connected to any position of the curved inner catheter section 2200. For example, in one embodiment, the distal end of the puller wire 2200b can be connected to the distal end, middle section, or another position of the curved inner catheter section 2200. Those skilled in the art can adjust the connection position of the puller wire 2200b and the curved inner catheter section 2200 based on the bending control requirements of the curved inner catheter section 2200 without being limited to the present application.

[0039] The puller wire 2200b may be directly or indirectly connected to the curved inner catheter section 2200. For example, the puller wire 2200b may be connected to the curved inner catheter section 2200 by ligation, intertwining, welding, etc. Alternatively, the curved inner catheter section 2200 may be provided with a traction anchor 2210 for connecting the puller wire 2200b to the curved inner catheter section 2200. In this case, the position of the puller wire 2200b on the curved inner catheter section 2200 becomes the position of the traction anchor 2210 on the curved inner catheter section 2200.

[0040] When connected to the curved inner catheter section 2200, the puller wire 2200b can extend axially to the proximal end. For example, the puller wire 2200b can extend axially through a gap between the inner catheter 2000 and the outer catheter 1000 to the proximal end. Alternatively, the inner catheter 2000 can include a puller lumen 2200a, and the puller wire 2200b can be inserted into the puller lumen 2200a of the inner catheter 2000 so that the puller wire 2200b extends axially to the proximal end. Because the puller wire 2200b is disposed within the inner catheter 2000, manipulation of the puller wire 2200b can bend the delivery system distally without affecting the relative axial movement of the inner catheter 2000 and the outer catheter 1000, i.e., the advancement and retraction of the outer catheter 1000 relative to the inner catheter 2000. The release and retrieval of the stent body D with the valve C can be controlled by advancing and retracting the outer catheter 1000. Without limitation, the advancement and retraction of the outer catheter 1000 can be controlled by a button.

[0041] Because the diameter of the curved inner catheter section 2200 is larger than the diameter of the pushing inner catheter section 2100, the connection between the curved inner catheter section 2100 and the curved inner catheter section 2200 can be a transition or a step-like transition of diameter. For example, the proximal end of the curved inner catheter section 2200 has a changing diameter segment connected to the distal end of the pushing inner catheter section 2100. The diameter of the changing diameter segment of the curved inner catheter section 2200 gradually decreases from the distal end to the proximal end, thereby forming a transitional connection between the curved inner catheter section 2200 and the pushing inner catheter section 2100, which have different diameters. Furthermore, the traction lumen 2200a extending through the curved inner catheter section 2200 and the pushing inner catheter section 2100 changes radial distance from the central axis of the inner catheter 2000 in response to the change in diameter of the curved inner catheter section 2200 and the pushing inner catheter section 2100. Continuing to refer to FIG. 1, along the direction of the pulling force F of the puller wire 2200b, the puller lumen 2200a and the puller wire 2200b therein have radial distances L2 and L1 in the curved inner catheter section 2200 and the pressed inner catheter section 2100, respectively, where L2 is less than L1.

[0042] The curved outer catheter section 1200 may be constructed using layers of different materials. For example, the curved outer catheter section 1200 may have an outer polymer layer, an inner polymer layer, and a machined metal reinforcement layer disposed between the outer and inner polymer layers. The outer polymer layer may be constructed using a flexible material such as polyurethane or polyamide polyether copolymer, and the inner polymer layer may be constructed using a flexible material such as polytetrafluoroethylene, polyurethane, or polyamide polyether copolymer. Because the curved outer catheter section 1200 is required to have properties such as flexibility, high pressure resistance, and good hoop stiffness, the machined metal reinforcement layer may be constructed using a highly elastic NiTi alloy material. Those skilled in the art can manufacture the curved outer catheter section 1200 as needed without limiting the scope of the present application.

[0043] 4 to 6, in one embodiment, the reinforcing structures 1210 are provided on the outer surface of the curved outer catheter section 1200. The reinforcing structures 1210 may be provided in any suitable form. For example, the reinforcing structures 1210 may be reinforcing ribs provided on the outer surface of the curved outer catheter section 1200. The number of reinforcing ribs may be two or more. The reinforcing ribs may be distributed along the axial direction of the curved outer catheter section 1200. Referring to FIG. 5, the reinforcing structures 1210 are provided as arc-shaped elements arranged around the periphery of the curved outer catheter section 1200, with multiple reinforcing structures arranged in parallel. The arc-shaped elements may be symmetrically arranged on opposite sides of the curved outer catheter section 1200. This axial distribution of the reinforcing structures 1210 provides good compression resistance and excellent bending properties in a plane perpendicular to the reinforcing structures 1210.

[0044] Referring to FIG. 6 , the distal end of the curved outer catheter section 1200 is provided with a variable segment 1220, which includes a straight cylindrical configuration and a tapered cylindrical configuration. The variable segment 1220 is configured to change between the straight cylindrical configuration and the tapered cylindrical configuration. Thus, the variable segment 1220 has a flared, or tapered, cylindrical configuration that functions as a guide during retrieval of the stent body D, and may return to its original, or straight, cylindrical configuration after retrieval is complete. The variable segment 1220 can be provided in various forms. For example, as shown in FIG. 6 , the variable segment 1220 is provided as a plurality of straight struts arranged circumferentially around the curved outer catheter section 1200. One end of the plurality of straight struts is connected to the distal end of the curved outer catheter section 1200, forming a fixed diameter. Meanwhile, the other end of the plurality of straight struts points toward the distal end, forming a cantilever structure. This causes the straight struts to flex inwardly and the deformable segments 1220 to assume a tapered cylindrical configuration when radially inward stress is applied during retrieval of the stent body D, and then return to the straight cylindrical configuration when such stress is removed.

[0045] The proximal end of the curved outer catheter section 1200 has a changing diameter segment connected to the distal end of the pressed outer catheter section 1100. The diameter of the changing diameter segment of the curved outer catheter section 1200 gradually decreases from the distal end to the proximal end. The curved outer catheter section 1200 may match the curved inner catheter section 2200 in length. For example, the changing diameter segment at the proximal end of the curved inner catheter section 2200 may terminate at the changing diameter segment at the proximal end of the curved outer catheter section 1200.

[0046] The pushing outer catheter section 1100 may be constructed with layers of different materials. For example, the pushing outer catheter section 1100 may be a composite catheter composed of an outer polymer layer, an inner polymer layer, an outer catheter braid layer, and a distal metal ring. The outer polymer layer may be composed of polyamide, polyamide-polyether copolymer, or another material, and the inner polymer layer may be composed of polytetrafluoroethylene, high-density polyethylene, polyamide, polyamide-polyether copolymer, or another material. The outer catheter braid layer may be positioned between the outer and inner polymer layers and braided with a metal reinforcing wire. To reinforce the structure of the pushing outer catheter section 1100, the pushing outer catheter section 1100 may further include reinforcing structures 1210, such as reinforcing ribs, symmetrically arranged on opposite sides of the axial direction. Symmetrically arranging the reinforcing ribs on opposite sides of the pushing outer catheter section 1100 not only provides good bending flexibility in a plane perpendicular to the reinforcing ribs, but also provides desired compression resistance.

[0047] In one embodiment, the distal end of the pressed outer catheter section 1100 may be connected to the proximal end of the curved outer catheter section 1200 by heat sealing or the like. Furthermore, a connection ring 1300 may be provided between the distal end of the pressed outer catheter section 1100 and the proximal end of the curved outer catheter section 1200. The connection ring 1300 is inserted at the connection position between the pressed outer catheter section 1100 and the curved outer catheter section 1200 and a portion adjacent to the connection position. The connection ring 1300 is used to surround and reinforce the connection position between the distal end of the pressed outer catheter section 1100 and the proximal end of the curved outer catheter section 1200.

[0048] To reinforce the structure of the pressing outer catheter section 1100, the pressing outer catheter section 1100 may be provided with an outer catheter reinforcing member 1110, which may employ reinforcing ribs or the like, with two or more reinforcing ribs arranged along the axial direction of the pressing outer catheter section 1100. The connection ring 1300 may be manufactured using a metal material, and the distal end of the pressing outer catheter section 1100 may be connected to the connection ring 1300 by welding. In addition, the connection ring 1300 at the distal end of the pressing outer catheter section 1100 is welded and connected to the outer catheter reinforcing member 1110, with a weld position 1110a formed between the connection ring 1300 and the outer catheter reinforcing member 1110. This allows the outer catheter reinforcing member 1110 to provide better support, ensure stable release and retrieval of the stent body D, and avoid excessive stress being applied to the pressing inner catheter section 2100 when retrieving the stent body D, and prevent the reinforcing ribs at the ends from falling off, causing a sudden drop in compression resistance.

[0049] The curved inner catheter section 2200 has a bendable backbone 2250 and a bendable protective layer. The bendable backbone 2250 is disposed within the bendable protective layer and functions as a backbone of the curved inner catheter section 2200, with the bendable protective layer covering and protecting the backbone. The bendable backbone 2250 can be provided in various forms. Referring to FIG. 7 , in one embodiment, the bendable backbone 2250 has a backbone tube 2251, and the wall of the backbone tube 2251 has curved auxiliary openings 2251a formed in it. The curved auxiliary openings 2251a are linear openings and are arranged around the circumference of the backbone tube 2251. The curved auxiliary openings 2251a may be arranged around at least a portion of the circumference of the backbone tube 2251. There may be multiple curved auxiliary openings 2251a. The multiple curved auxiliary openings 2251a may be arranged along the axial direction of the backbone tube 2251 and symmetrically arranged on opposite sides of the backbone tube 2251. The curved auxiliary openings 2251a on one side may be offset from the curved auxiliary openings 2251a on the other side along the axial direction. Those skilled in the art can arrange the curved auxiliary openings 2251a as needed without limiting the present application.

[0050] In one embodiment, the bendable protective layer can include a bendable inner protective layer and a bendable outer protective layer. The bendable outer protective layer is disposed on the outer surface of the backbone tube 2251, and the bendable inner protective layer is disposed on the inner surface of the backbone tube 2251, enveloping the backbone tube 2251. The bendable outer protective layer can be formed of a flexible polymer material such as polyurethane or polyamide polyether copolymer, and the bendable inner protective layer can be formed of a polymer such as polytetrafluoroethylene, high-density polyethylene, polyurethane, or polyamide polyether copolymer. The backbone tube 2251 can be formed of a metal material, in which case the backbone tube 2251 with the curved auxiliary openings 2251a can be manufactured by laser cutting.

[0051] Referring to FIG. 7 , in one embodiment, the flexible backbone 2250 has multiple rotatable elements 2252 arranged along the axial direction of the flexible backbone 2250. Adjacent rotatable elements 2252 are articulated with each other, and adjacent rotatable elements 2252 are rotatably connected to a fixed shaft, with multiple rotation axes between the multiple rotatable elements 2252 being parallel to each other. The rotatable elements 2252 are, for example, snake-bone-like elements connected by rivets to form the backbone tube 2251. The riveted snake-bone structure exhibits excellent compliance, uniformly distributes the force from the puller wire 2200b throughout the backbone tube 2251, and significantly reduces the flexural modulus of the backbone tube 2251. The riveted snake-bone structure exhibits excellent tensile performance. The flexible protective layer can be made of a flexible polymer material such as polyurethane or polyamide polyether copolymer and can be directly disposed on the outer surface of the flexible backbone 2250.

[0052] 9 , in one embodiment, the pushable inner catheter section 2100 includes an inner catheter inner layer 2110, an inner catheter outer layer 2120, and an inner catheter braided layer 2130 disposed between the inner catheter inner layer 2110 and the inner catheter outer layer 2120. At least one of a guide lumen 2100a and a traction lumen 2200a is formed within the inner catheter inner layer 2110. The inner catheter outer layer 2120 may be formed of a matrix material such as polyamide or polyamide polyether copolymer, and the inner catheter inner layer 2110 may be formed of a self-lubricating polytetrafluoroethylene material, which imparts self-lubricity to the traction lumen 2200a formed by the inner catheter inner layer 2110. An inner catheter reinforcing element 2140 is disposed within the inner catheter inner layer 2110, positioned between the guide lumen 2100a and the traction lumen 2200a.

[0053] The traction lumen 2200a is provided with a bend-resistant support tube 2200c. The bend-resistant support tube 2200c exhibits bending resistance, allowing the compressed inner catheter section 2100, including the traction lumen 2200a, to withstand greater stress and minimize deformation under the pulling force of the puller wire 2200b. As a non-limiting example, the bend-resistant support tube 2200c can be implemented as a high-density compression spring tube or the like. The high-density compression spring tube can be disposed between the inner catheter inner layer 2110 and the inner catheter braided layer 2130, which can enhance the hoop restraint force. When tension is applied to the puller wire 2200b, the inner catheter 2000 tends to contract due to the force acting along its axial direction. However, because the high-density compression spring tube provides sufficient support, the inner catheter 2000 as a whole undergoes only slight deformation. When the inner catheter 2000 is bent, a force perpendicular to its axis is generated. However, the restraint of the inner catheter braided layer 2130 can impart higher hoop stiffness, thereby preventing the inner catheter 2000 from deforming in the circumferential direction.

[0054] 10 , the proximal end of the pushing inner catheter section 2100 is provided with an inner catheter connecting segment 2300, and the pushing outer catheter section 1100 can be provided with a corresponding outer catheter connecting portion 1120 that is extrapolated to the inner catheter connecting segment 2300. The inner catheter connecting segment 2300 is provided with a wire withdrawal port 2310 that communicates with the traction lumen 2200a, and the proximal end of the puller wire 2200b is withdrawn from this withdrawal port. The distal end of the inner catheter connecting segment 2300 is connected to the pushing inner catheter section 2100, and the proximal end of the inner catheter connecting segment 2300 is configured to be connected to a gripping member 3000, such as a handle. The inner catheter connecting segment 2300 can be provided with a thread 3200 at its proximal end, allowing the inner catheter connecting segment to be connected to the gripping member 3000 via threaded engagement. The gripping member 3000 may be provided with a rotatable rotation control member 3100 to control the tightening or loosening of the puller wire 2200b. The inner catheter connecting segment 2300 is a reinforcing tube made of a metallic material with structural reinforcement properties and may be composed of a first connecting segment 2300a and a second connecting segment 2300b. The proximal end of the first connecting segment 2300a is connected to the gripping member 3000, and the distal end of the first connecting segment 2300a is connected to the proximal end of the second connecting segment 2300b. The distal end of the second connecting segment 2300b is connected to the pushing inner catheter section 2100 by an integral fusion. This integral fusion ensures smooth passage for overall bending control. In this case, a high-density compression spring tube extends from the distal end to the wire withdrawal port 2310 and does not obstruct the axial passage of the puller wire 2200b.

[0055] 11 to 21, the traction fixation member 2210 is disposed at the distal end of the curved inner catheter section 2200. Referring to Figure 13, the traction fixation member 2210 has a first inner lumen 2210a that communicates with the guide lumen 2100a, thereby allowing the guide wire 2100b to protrude from the distal end of the traction fixation member 2210. The traction fixation member 2210 is provided with a first wire attachment member 2210b, and the puller wire 2200b is connected to the first wire attachment member 2210b and further connected to the distal end of the curved inner catheter section 2200.

[0056] The curved inner catheter section 2200 has a stent-fixing member 2220 at its proximal end, which connects the curved inner catheter section 2200 to the distal end of the pushing inner catheter section 2100. Referring to FIG. 14 , the stent-fixing member 2220 has a second inner lumen 2220a communicating with the guide lumen 2100a. The second inner lumen 2220a allows the guidewire 2100b to protrude from the proximal end of the stent-fixing member 2220. The stent-fixing member 2220 has a stent-fixing element 2220c for fixing the stent body D equipped with the valve C. Specifically, the proximal portion of the stent body D equipped with the valve C is positioned on the curved inner catheter section 2200 by the stent-fixing member 2220, so that the stent body D is crimped onto the curved inner catheter section 2200. The stent fixing member 2220 has a side puller wire lumen 2220b that communicates with the puller lumen 2200a. The proximal end of the puller wire 2200b is inserted into the side puller wire lumen 2220b and extends proximally, and is finally pulled out from the wire pull-out port 2310 of the inner catheter connecting segment 2300.

[0057] 15 and 16, the traction fixation member 2210, the bendable backbone 2250, the stent fixation member 2220, and the fusion connector claw 2260 are welded to the fixation assembly. The puller wires 2200b can be connected to the traction fixation member 2210 in various ways. For example, two puller wires 2200b can be passed proximally through the bendable backbone 2250 and then through the side puller wire holes 2220b of the stent fixation member 2220 to suspend the puller wires 2200b from the traction fixation member 2210. The fusion connector claw 2260 can then be heat-sealed and wrapped around the distal end of the push inner catheter section 2100. With this configuration, the side puller wire holes 2220b of the stent fixation member 2220 communicate with the guide lumen 2200a of the inner catheter 2000, forming a complete traction lumen 2200a.

[0058] 17 to 21, when a pulling force directed toward the proximal end is applied to the puller wire 2200b, the curved inner catheter section 2200 and the curved outer catheter section 1200 may bend to some extent depending on their respective bending moduli and lengths. To ensure the performance of the valve C, the lengths of the curved inner catheter section 2200 and the curved outer catheter section 1200 may be shorter than the distance between the traction fixation member 2210 and the valve C.

[0059] After the stent body D with the valve C is loaded into the inner catheter 2000 and outer catheter 1000 of the delivery system, the inner catheter 2000 and outer catheter 1000 can be advanced through the aortic arch A. If resistance is encountered, both the curved inner catheter section 2200 and the curved outer catheter section 1200 are deflected at a small angle before being advanced. After deflection, the distal ends of both the curved inner catheter section 2200 and the curved outer catheter section 1200, as well as the puller wire 2200b, are released from the vessel wall, facilitating advancement. If the inner catheter 2000 and the outer catheter 1000 are not steerable, they will generally straighten after passing through the aortic arch A and the annulus and will be oriented at a relatively large angle relative to the annulus plane B. Releasing the stent body D at this point may result in the stent body D becoming dislodged or tilted. In contrast, according to the present application, the deflection of both the inner catheter 2000 and the outer catheter 1000 is adjusted as they cross the annulus. The stent body D and the guide wire 2100b bend together with the inner catheter 2000 and the outer catheter 1000, so that the inner catheter 2000 and the outer catheter 1000 are perpendicular to the annular plane B. The angle at which the inner catheter 2000 and the outer catheter 1000 bend may vary depending on the actual anatomical structure of the valve arch, and the present application is not particularly limited in this regard.

[0060] The controlled deflection adjustment of both the inner catheter 2000 and the outer catheter 1000 allows for controlled curvature of the stent body D. Adjusting the curvature angle enables coaxial deployment suitable for over 98% of patient anatomies. During the procedure, the outer catheter 1000 can be retracted by operating a push button on the handle. The inner catheter 2000, with its controlled bending mechanism, maintains a stable bending state throughout the entire release process, and the stent body D remains perpendicular to the annulus plane B. This allows for stable and accurate release of the stent body D at the target site. Furthermore, the stent body D is passively steered at its trailing end. After the stent body D is stably anchored, the steering action is released for complete release. The anchoring of the stent body D is completely unaffected.

[0061] 22-29, the curved inner catheter section 2200 can have a first axial inner catheter segment 2230 and a second axial inner catheter segment 2240. As a non-limiting alternative to this two-segment configuration, the curved inner catheter section 2200 can include three or more segments. The traction fixation member 2210 is disposed at the distal end of the second inner catheter segment 2240 and includes a first inner lumen 2210a. The first inner lumen 2210a is in communication with the guide lumen 2100a and is configured to allow a guidewire 2100b to protrude from the distal end of the traction fixation member 2210. The traction fixation member 2210 can include a first wire attachment member 2210b, and the puller wire 2200b is connected to the first wire attachment member 2210b and further connected to the distal end of the curved inner catheter section 2200.

[0062] The distal end of the first inner catheter segment 2230 may be connected to the proximal end of the second inner catheter segment 2240 by a stent-fixing member 2220 having a second lumen 2220a. The second lumen 2220a communicates with the guide lumen 2100a and is configured to allow a guidewire 2100b to protrude from the proximal end of the stent-fixing member 2220. The stent-fixing member 2220 may include a stent-fixing element 2220c for securing a stent body D having a valve C. Specifically, a proximal portion of the stent body D having the valve C is sleeved around the curved inner catheter section 2200 by the stent-fixing member 2220, and the stent body D is crimped to the curved inner catheter section 2200. The stent-fixing member 2220 may include a lateral pullwire lumen 2220b communicating with the pull lumen 2200a. The proximal end of the puller wire 2200 b is inserted into the lateral puller wire hole 2220 b and extends proximally, and is finally pulled out from the wire withdrawal port 2310 of the inner catheter connection segment 2300 .

[0063] 24 and 25, the traction fixation member 2210, the bendable backbone 2250 in the second inner catheter segment 2240, the stent fixation member 2220, the bendable backbone 2250 in the first inner catheter segment 2230, and the fused connector claw 2260 are welded to the fixation assembly. The puller wires 2200b can be connected to the traction fixation member 2210 in various ways. For example, two puller wires 2200b can be sequentially threaded proximally through the bendable backbone 2250 in the second inner catheter segment 2240, through the lateral puller wire holes 2220b of the stent fixation member 2220, and through the bendable backbone 2250 of the first inner catheter segment 2230 to suspend the puller wires 2200b from the traction fixation member 2210. The fused connector claw 2260 is heat-sealed and wrapped around the distal end of the pressed inner catheter section 2100. With this configuration, the side puller wire hole 2220b of the stent fixing member 2220 communicates with the guide lumen 2200a of the inner catheter 2000, forming a complete puller lumen 2200a.

[0064] 26 to 29, when a pulling force directed toward the proximal end is applied to the puller wire 2200b, the curved inner catheter section 2200 and the curved outer catheter section 1200 may bend to some extent depending on their respective bending moduli and lengths. To ensure the performance of the valve C, the lengths of the curved inner catheter section 2200 and the curved outer catheter section 1200 can be shorter than the distance between the traction fixation member 2210 and the valve C. Because the curved inner catheter section 2200 has a two-segment structure including a first inner catheter segment 2230 and a second inner catheter segment 2240 along the axial direction, it can bend to a large angle when a certain force is applied thereto.

[0065] After the stent body D with the valve C is loaded into the inner catheter 2000 and outer catheter 1000 of the delivery system, the inner catheter 2000 and outer catheter 1000 can be advanced through the aortic arch A. If resistance is encountered, a small angle of deflection is applied to both the curved inner catheter section 2200 and the curved outer catheter section 1200 before further advancement. After deflection, the distal ends of both the curved inner catheter section 2200 and the curved outer catheter section 1200, as well as the puller wire 2200b, move away from the vessel wall, facilitating advancement. After passing through the valve annulus, the deflection of both the inner catheter 2000 and the outer catheter 1000 is adjusted. The stent body D and the guidewire 2100b bend together with the inner catheter 2000 and outer catheter 1000, and the inner catheter 2000 and outer catheter 1000 are perpendicular to the annular plane B. The angle at which the inner catheter 2000 and the outer catheter 1000 are bent may vary depending on the actual anatomical structure of the arch, and the present application is not particularly limited in this regard.

[0066] The two-segment structure of the curved inner catheter section 2200, which includes a first inner catheter segment 2230 and a second inner catheter segment 2240 along the axial direction, is a labor-saving design suitable for 90% of patients and a wider range of applications. During the procedure, the outer catheter 1000 can be retracted by operating a push button on the handle. The inner catheter 2000, thanks to its controlled bending mechanism, maintains a stable bending state throughout the release process, and the stent body D remains perpendicular to the annulus plane B. This effectively ensures stable and accurate release of the stent body D at the target site. Furthermore, the stent body D is passively steered at its rear end. Once the stent body D is stably anchored, the steering action is released for complete release. Therefore, the anchoring of the stent body D is not affected at all.

[0067] 30 to 38 , the stent-fixing member 2220 is provided at the distal end of the curved inner catheter section 2200, and the proximal end of the curved inner catheter section 2200 may be directly connected to the pushing inner catheter section 2100. The stent-fixing member 2220 has a second inner lumen 2220a that communicates with the guide lumen 2100a and is configured to allow a guidewire 2100b to protrude from the distal end of the stent-fixing member 2220. The stent-fixing member 2220 may have a stent-fixing element 2220c for securing a stent body D equipped with a valve C, where the stent body D equipped with the valve C does not cover the curved inner catheter section 2200. The stent-fixing member 2220 may further have a second wire mounting member 2220d, and the puller wire 2200b may be connected to the second wire mounting member 2220d. With this configuration, the stent fixing member 2220 has both the function of fixing the stent body D at the distal end of the curved inner catheter section 2200 and the function of connecting the puller wire 2200b.

[0068] 33 and 34, the stent fixation member 2220, the bendable backbone 2250, and the fused connector claws 2260 are welded into a fixation assembly. The puller wires 2200b can be connected to the stent fixation member 2220 in a variety of ways. For example, two puller wires 2200b can be passed proximally through the bendable backbone 2250 and pulled into the traction lumen 2200a of the inner catheter 2000, thereby suspending the puller wires 2200b from the traction fixation member 2210. The fused connector claws 2260 are heat-sealed and wrapped around the distal end of the pressed inner catheter section 2100.

[0069] 35 to 38, when a pulling force directed toward the proximal end is applied to the puller wire 2200b, the curved inner catheter section 2200 and the curved outer catheter section 1200 may bend to some extent depending on their respective bending moduli and lengths. To ensure the performance of the valve C, the lengths of the curved inner catheter section 2200 and the curved outer catheter section 1200 may be shorter than the distance between the traction fixation member 2210 and the valve C.

[0070] In these embodiments, the stent body D is secured to the stent fixation member 2220 at its distal end, preventing steering of the curved inner catheter section 2200 and the curved outer catheter section 1200 to bend the stent body D. Therefore, they have a relatively long, straight length. This configuration is suitable for use in patients with long ascending aortas and can achieve coaxial release in over 80% of patients. After loading the stent body D with the valve C into the inner catheter 2000 and outer catheter 1000 of the delivery system, the inner catheter 2000 and outer catheter 1000 can be advanced through the aortic arch A. If resistance is encountered, both the curved inner catheter section 2200 and the curved outer catheter section 1200 are deflected by a small angle before being advanced. After deflection, the distal ends of both the curved inner catheter section 2200 and the curved outer catheter section 1200, as well as the puller wire 2200b, move away from the vessel wall, facilitating advancement and aligning the curved inner catheter section 2200 and the curved outer catheter section 1200 perpendicular to the annulus plane B.

[0071] During the procedure, the outer catheter 1000 can be pulled back by operating the push button on the handle, and the inner catheter 2000, thanks to its controlled bending mechanism, maintains a stable bending state throughout the entire release process, and the stent body D remains perpendicular to the annular plane B. This allows the stent body D to be stably and accurately released at the target site. Furthermore, the stent body D is passively steered at its rear end, and after the stent body D is stably anchored, the steering action is released and the stent body D is completely released. Therefore, the anchoring of the stent body D is not affected at all.

[0072] The various technical features of the foregoing embodiments may be combined in any manner, and for the sake of brevity, not all combinations thereof are described above, but any combination thereof is deemed to be within the scope of this specification, provided there is no conflict between the technical features.

[0073] The above are merely some embodiments of the present application. Although these embodiments have been described with a certain degree of specificity and detail, they are not intended to limit the scope of the present application in any way. It goes without saying that those skilled in the art can make various changes and modifications without departing from the concept of the present application. Therefore, all such variations and modifications are intended to be included within the scope of the present application as defined by the appended claims. [Explanation of symbols]

[0074] A: Aortic arch B: Annular plane C: Artificial valve D: Stent body E: Support point F: Anchoring point G: Pulling direction 1000: Outer catheter 2000: Inner catheter 3000: Gripping member 1100: Pressed outer catheter section 1200: Curved outer catheter section 1300: Connecting ring 1110: Outer catheter reinforcing member 1110a: Welding position 1120: Outer catheter connection part 1210: Reinforced structure 1220: Variable segment 2100a: Guidance lumen 2100b: Guidewire 2200a: Traction lumen 2200b: Towing wire 2200c: Bending-resistant support tube 2100: Pressed inner catheter section 2200: Curved inner catheter section 2300: Inner catheter connection segment 2300a: First connected segment 2300b: Second connecting segment 2110: Inner catheter lining 2120: Inner catheter outer layer 2130: Inner catheter braid layer 2140: Inner catheter stiffening element 2210: Towing and fixing member 2220: Stent fixing member 2230: First inner catheter segment 2240: Second inner catheter segment 2250: Flexible backbone 2260: Fusion Connection Claw 2310: Wire outlet 2210a: First inner hole 2210b: First wire attachment member 2220a: Second inner hole 2220b: Lateral traction wire hole 2220c: Stent fixation element 2220d: Second wire attachment member 2251: Backbone tube 2251a: Curved auxiliary opening 2252: Rotatable elements 3100: Rotation control member 3200:Screw

Claims

1. an outer catheter having an axial lumen; an inner catheter having a guide lumen, the inner catheter being movably disposed within the axial lumen of the outer catheter, the inner catheter having a pushing inner catheter section and a curved inner catheter section along the axial direction, the distal end of the pushing inner catheter section being connected to the proximal end of the curved inner catheter section, and the diameter of the curved inner catheter section being larger than the diameter of the pushing inner catheter section; a guide wire inserted into the guide lumen of the inner catheter; a puller wire connected to the curved inner catheter section; A delivery system comprising:

2. The delivery system of claim 1 , wherein a distal end of the puller wire is connected to a distal end of the curved inner catheter section.

3. 10. The delivery system of claim 1, wherein the curved inner catheter section is provided with a traction anchor, and the puller wire is connected to the curved inner catheter section via the traction anchor.

4. The delivery system of claim 3 , wherein the traction fixation member has a first lumen in communication with the guide lumen.

5. 4. The delivery system of claim 3, wherein the traction fixation member is provided with a first wire attachment member, and the traction wire is connected to the first wire attachment member.

6. The delivery system of claim 1 , wherein the inner catheter has a traction lumen, and the puller wire is inserted within the traction lumen of the inner catheter.

7. The delivery system of claim 6 , wherein the traction lumen is provided with a bow-resistant support tube within it.

8. 7. The delivery system of claim 6, wherein the proximal end of the pushing inner catheter section is provided with an inner catheter connecting segment, the inner catheter connecting segment is provided with a wire pull-out port, the wire pull-out port is in communication with the pull-out lumen, and the proximal end of the pull-out wire is pulled out from the wire pull-out port.

9. 10. The delivery system of claim 1, wherein the proximal end of the curved inner catheter section has a changing diameter segment connected to the distal end of the pressed inner catheter section, the diameter of the changing diameter segment of the curved inner catheter section gradually decreasing from the distal end to the proximal end.

10. The delivery system of claim 1 , wherein the curved inner catheter section is provided with a stent fixation member.

11. 11. The delivery system of claim 10, wherein the stent fixing member is provided at a proximal end of the curved inner catheter section, and the curved inner catheter section is connected to a distal end of the pressed inner catheter section via the stent fixing member.

12. The delivery system of claim 10 , wherein the stent fixation member is provided at a distal end of the curved inner catheter section.

13. 11. The delivery system of claim 10, wherein the curved inner catheter section has a first inner catheter segment and a second inner catheter segment along an axial direction, and a distal end of the first inner catheter segment is connected to a proximal end of the second inner catheter segment via the stent fixation member.

14. The delivery system of claim 10 , wherein the stent fixation member has a second lumen in communication with the guide lumen.

15. The delivery system of claim 10 , wherein the stent fixation member comprises a stent fixation element.

16. 10. The delivery system of claim 1, wherein the curved inner catheter section has a bendable backbone and a bendable protective layer, the bendable backbone being disposed within the bendable protective layer.

17. 17. The delivery system of claim 16, wherein the bendable backbone comprises a backbone tube having a wall with curved auxiliary openings.

18. 18. The delivery system of claim 17, wherein the curved auxiliary openings are linear openings, the curved auxiliary openings are arranged circumferentially around the backbone tube, there are a plurality of the curved auxiliary openings, and the plurality of curved auxiliary openings are distributed along the axial direction of the backbone tube.

19. 18. The delivery system of claim 17, wherein the bendable protective layer comprises a bendable inner protective layer and a bendable outer protective layer, the bendable outer protective layer being disposed on an outer surface of the backbone tube and the bendable inner protective layer being disposed on an inner surface of the backbone tube.

20. 17. The delivery system of claim 16, wherein the flexible backbone comprises a plurality of rotatable elements distributed along an axial direction of the flexible backbone, and adjacent rotatable elements are articulated to each other.

21. 21. The delivery system of claim 20, wherein adjacent rotatable elements are rotatably coupled to a fixed axis, and the rotation axes of the plurality of rotatable elements are parallel.

22. 2. The delivery system of claim 1, wherein the pressed inner catheter section has an inner catheter inner layer and an inner catheter outer layer, an inner catheter braided layer is disposed between the inner catheter inner layer and the inner catheter outer layer, and at least one of the guide lumen and the traction lumen is formed within the inner catheter inner layer.

23. 23. The delivery system of claim 22, wherein at least one inner catheter reinforcing element is disposed within the inner catheter lining and is located between the guide lumen and the traction lumen.

24. 2. The delivery system of claim 1, wherein the outer catheter has a pressed outer catheter section and a curved outer catheter section along an axial direction, the distal end of the pressed outer catheter section being coupled to the proximal end of the curved outer catheter section.

25. 25. The delivery system of claim 24, wherein the distal end of the curved outer catheter section has a variable shape segment including a straight cylindrical configuration and a tapered cylindrical configuration, the variable shape segment configured to change between the straight cylindrical configuration and the tapered cylindrical configuration.

26. 25. The delivery system of claim 24, wherein the proximal end of the curved outer catheter section has a changing diameter segment connected to the distal end of the pressed outer catheter section, the diameter of the changing diameter segment of the curved outer catheter section gradually decreasing from the distal end to the proximal end.

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