Delivery assembly and delivery system

Abstract

The present application relates to a kind of conveying assembly, outer catheter has axial inner cavity, inner catheter has guide inner cavity, inner catheter is movably assembled in the axial inner cavity of outer catheter, wherein, inner catheter includes push inner tube section and curved inner tube section in axial direction, the distal end of push inner tube section is connected with the proximal end of curved inner tube section, the pipe diameter of curved inner tube section is greater than the pipe diameter of push inner tube section, guide wire is passed in the guide inner cavity of inner catheter, traction wire is connected with curved inner tube section.The conveying assembly described above, when the connecting position of traction wire and curved inner tube section is determined, traction wire can be pulled to the corresponding position of curved inner tube section to form pulling, to make curved inner tube section form bending, since the pipe diameter of curved inner tube section is greater than the pipe diameter of push inner tube section, so when traction wire pulls the curved inner tube section of larger pipe diameter, it can generate greater moment perpendicular to the section of curved inner tube section, thereby good bending control effect is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a delivery assembly and a delivery system. BACKGROUND

[0002] Heart valve replacement surgery, such as aortic valve replacement, mitral valve replacement, tricuspid valve replacement and pulmonary valve replacement, is to deliver a valve to a designated position through a catheter of a delivery system for valve positioning and release, to replace the original valve, which is a hot technology in the field of valve heart disease treatment. For example, transcatheter aortic valve replacement can treat aortic valve disease without thoracotomy and without stopping the heart, which avoids the great trauma caused by thoracotomy and heart arrest to patients.

[0003] At present, the catheter of the delivery system used in transcatheter aortic valve replacement cannot actively control bending. When the catheter of the delivery system passes through the aortic arch, it needs to rely on the reaction force exerted by the inner wall of the blood vessel to passively bend, so as to smoothly pass through the aortic arch. In this process, the inner wall of the blood vessel may be damaged to a certain extent, thereby causing a certain degree of vascular complications. Meanwhile, in the subsequent cross-valve and coaxial adjustment process of transcatheter aortic valve replacement, the catheter of the delivery system cannot actively control bending, which also makes the surgical operation very difficult, affecting the release and fixation of the valve. Therefore, how to realize the active bending control of the catheter of the delivery system is a technical problem to be solved in the field. SUMMARY

[0004] Therefore, it is necessary to provide a delivery assembly aiming at the above-mentioned technical problems.

[0005] The present application provides a delivery assembly, which comprises:

[0006] an outer catheter having an axial inner cavity;

[0007] an inner catheter having a guide inner cavity, the inner catheter being movably assembled in the axial inner cavity of the outer catheter, wherein the inner catheter comprises a pushing inner tube segment and a bending inner tube segment in the axial direction, the distal end of the pushing inner tube segment being connected to the proximal end of the bending inner tube segment, and the tube diameter of the bending inner tube segment being greater than the tube diameter of the pushing inner tube segment;

[0008] a traction wire connected to the bending inner tube segment;

[0009] a stent body on which a valve is assembled, the stent body and the valve being configured to be assembled between the inner catheter and the outer catheter.

[0010] In one embodiment, the distal end of the traction wire is connected to the distal end of the bending inner tube segment; and / or,

[0011] The curved inner tube segment is provided with a traction fixing member, and the traction wire is connected with the curved inner tube segment through the traction fixing member; and / or,

[0012] The inner catheter has a traction inner cavity, and the traction wire is arranged in the traction inner cavity of the inner catheter;

[0013] The proximal end of the curved inner tube segment has a variable diameter segment, and the variable diameter segment of the curved inner tube segment is connected with the distal end of the pushing inner tube segment, wherein the tube diameter of the variable diameter segment of the curved inner tube segment gradually decreases from the distal end to the proximal end.

[0014] In one of the embodiments, the traction fixing member has a first inner cavity hole, and the first inner cavity hole is communicated with the guide inner cavity; and / or,

[0015] The traction fixing member is provided with a first wire hanging part, and the traction wire is connected with the first wire hanging part; and / or,

[0016] The proximal end of the pushing inner tube segment is provided with a connecting inner tube segment, the connecting inner tube segment is provided with a wire leading-out hole, the wire leading-out hole is communicated with the traction inner cavity, and the proximal end of the traction wire is led out from the wire leading-out hole;

[0017] And / or, a bending-resistant support tube is arranged in the traction inner cavity.

[0018] In one of the embodiments, the curved inner tube segment is provided with a stent fixing member.

[0019] In one of the embodiments, the stent fixing member is arranged at the proximal end of the curved inner tube segment, and the proximal end of the curved inner tube segment is connected with the distal end of the pushing inner tube segment through the stent fixing member; or,

[0020] The stent fixing member is arranged at the distal end of the curved inner tube segment; or,

[0021] The curved inner tube segment includes a first inner tube segment and a second inner tube segment in the axial direction, and the distal end of the first inner tube segment is connected with the proximal end of the second inner tube segment through the stent fixing member.

[0022] In one of the embodiments, the stent fixing member has a second inner cavity hole, and the second inner cavity hole is communicated with the guide inner cavity; and / or,

[0023] The stent fixing member has a wire leading side hole, and the wire leading side hole is communicated with the traction inner cavity; and / or,

[0024] The stent fixing member has a stent fixing part.

[0025] In one of the embodiments, the curved inner tube section comprises a curved skeleton and a curved protective layer, the curved skeleton is arranged in the curved protective layer.

[0026] In one of the embodiments, the curved skeleton comprises a skeleton tube, an outer wall of the skeleton tube is provided with a bending assisting hollow hole; or, the curved skeleton comprises a plurality of rotating unit elements, the plurality of rotating unit elements are distributed along an axial direction of the curved skeleton, and adjacent rotating unit elements are movably connected.

[0027] In one of the embodiments, the bending assisting hollow hole is a linear hole, and the bending assisting hollow hole is arranged along a circumferential direction of the skeleton tube; and / or,

[0028] The number of the bending assisting hollow holes is a plurality, and the plurality of bending assisting hollow holes are distributed along the axial direction of the skeleton tube.

[0029] In one of the embodiments, adjacent rotating unit elements are connected in a shaft rotation mode, and a plurality of rotating shafts between the plurality of rotating unit elements are parallel to each other.

[0030] In one of the embodiments, the curved protective layer comprises a curved inner protective layer and a curved outer protective layer, the curved outer protective layer is arranged on an outer surface of the skeleton tube, and the curved inner protective layer is arranged on an inner surface of the skeleton tube; or,

[0031] The curved protective layer is arranged on an outer surface of the curved skeleton.

[0032] In one of the embodiments, the push inner tube section comprises an inner tube section inner layer and an inner tube section outer layer, an inner tube braided layer is arranged between the inner tube section inner layer and the inner tube section outer layer, and at least one of the guide inner cavity and the traction inner cavity is arranged in the inner tube section inner layer.

[0033] In one of the embodiments, at least one of the inner tube section inner layer and the inner tube braided layer is arranged with an inner tube reinforcing member, and the inner tube reinforcing member is located between the guide inner cavity and the traction inner cavity.

[0034] In one of the embodiments, the outer catheter comprises a push outer tube section and a curved outer tube section in an axial direction, a distal end of the push outer tube section is connected with a proximal end of the curved outer tube section.

[0035] In one of the embodiments, a distal end of the curved outer tube section has a deformation section, the deformation section has a straight cylinder state and a tapered cylinder state, and the deformation section is used to change between the straight cylinder state and the tapered cylinder state; and / or,

[0036] The proximal end of the curved outer tube section has a reducing section, and the reducing section of the curved outer tube section is connected with the distal end of the push outer tube section, wherein the tube diameter of the reducing section of the curved outer tube section gradually decreases from the distal end to the proximal end.

[0037] In one of the embodiments, a connecting ring is arranged between the distal end of the push outer tube section and the proximal end of the curved outer tube section; and / or,

[0038] An outer tube reinforcing member is arranged on the push outer tube section; and / or,

[0039] The push outer tube section has an outer tube braided layer.

[0040] The present application provides a delivery system, which comprises:

[0041] The delivery assembly;

[0042] A handle, which is drivingly connected with the delivery assembly.

[0043] In the delivery assembly and the delivery system, when the connection position of the pull wire and the curved inner tube section is determined, pulling the pull wire can form a pulling force on the corresponding position of the curved inner tube section, so as to make the curved inner tube section form a curve. Since the tube diameter of the curved inner tube section is larger than that of the push inner tube section, a larger torque perpendicular to the cross section of the curved inner tube section can be generated when the pull wire pulls the curved inner tube section with a larger tube diameter, thereby achieving a good bending control effect. BRIEF DESCRIPTION OF DRAWINGS

[0044] Figure 1 A bending principle diagram of an inner catheter is provided for an embodiment of the present application;

[0045] Figure 2 A structure diagram of an outer catheter is provided for an embodiment of the present application;

[0046] Figure 3 A structure diagram of a delivery assembly is provided for an embodiment of the present application;

[0047] Figure 4 A structure diagram of a curved outer tube section is provided for an embodiment of the present application;

[0048] Figure 5 A partial enlarged view I of the curved outer tube section is provided for the embodiment shown in Figure 4

[0049] Figure 6 A partial enlarged view II of the curved outer tube section is provided for the embodiment shown in Figure 4

[0050] Figure 7 ​​A structural schematic diagram of a skeleton tube provided for an embodiment of the present application;

[0051] Figure 8 A structural schematic diagram of a skeleton tube provided for another embodiment of the present application;

[0052] Figure 9 A sectional schematic diagram of a pushing inner tube segment provided for an embodiment of the present application;

[0053] Figure 10 A structural schematic diagram of a connecting inner tube segment provided for an embodiment of the present application;

[0054] Figure 11 A structural schematic diagram of an inner guide tube provided for an embodiment of the present application;

[0055] Figure 12 A bending state schematic diagram of an inner guide tube provided for an embodiment as shown in Figure 11

[0056] A structural schematic diagram of a traction fixing member provided for an embodiment of the present application; Figure 13

[0057] A structural schematic diagram of a bracket fixing member provided for an embodiment of the present application; Figure 14

[0058] An assembled stereoscopic structural schematic diagram of a traction fixing member, a skeleton tube and a bracket fixing member provided for an embodiment of the present application; Figure 15

[0059] An assembled planar structural schematic diagram of a traction fixing member, a skeleton tube and a bracket fixing member provided for an embodiment of the present application; Figure 16

[0060] A working state schematic diagram of a delivery assembly provided for an embodiment of the present application; Figures 17 to 21

[0061] A structural schematic diagram of an inner guide tube provided for another embodiment of the present application; Figure 22

[0062] A bending state schematic diagram of an inner guide tube provided for an embodiment as shown in Figure 23 Figure 22 An assembled stereoscopic structural schematic diagram of a traction fixing member, a skeleton tube and a bracket fixing member provided for another embodiment of the present application;

[0063] Figure 24 An assembled planar structural schematic diagram of a traction fixing member, a skeleton tube and a bracket fixing member provided for another embodiment of the present application;

[0064] Figure 25 ​​

[0065] Figures 26 to 29 A working state schematic diagram of a delivery assembly provided for another embodiment of the present application;

[0066] Figure 30 A structure schematic diagram of an inner catheter provided for another embodiment of the present application;

[0067] Figure 31 A bending state schematic diagram of an inner catheter provided for the embodiment as shown in Figure 30

[0068] Figure 32 A structure schematic diagram of a stent fixing member provided for another embodiment of the present application;

[0069] Figure 33 An assembly perspective structure schematic diagram of a traction fixing member, a skeleton tube and a stent fixing member provided for another embodiment of the present application;

[0070] Figure 34 An assembly plane structure schematic diagram of a traction fixing member, a skeleton tube and a stent fixing member provided for another embodiment of the present application;

[0071] Figures 35 to 38 A working state schematic diagram of a delivery assembly provided for an embodiment of the present application.

[0072] Reference signs:

[0073] A, aortic arch; B, annulus plane; C, valve; D, stent body; E, support point; F, anchoring point; G, withdrawal direction;

[0074] 1000, outer catheter; 2000, inner catheter; 3000, holding component;

[0075] 1100, push outer tube segment; 1200, bending outer tube segment; 1300, connecting ring;

[0076] 1110, outer tube reinforcing member; 1110a, welding position; 1120, connecting outer tube segment; 1210, cutting line; 1220, deformation segment;

[0077] 2100a, guide inner cavity; 2100b, guide wire; 2200a, traction inner cavity; 2200b, traction wire; 2200c, anti-bending support tube;

[0078] 2100, push inner tube segment; 2200, bending inner tube segment; 2300, connecting inner tube segment;

[0079] 2300a, first connecting segment; 2300b, second connecting segment;

[0080] ​2110, inner tube segment inner layer; 2120, inner tube segment outer layer; 2130, inner tube braid layer; 2140, inner tube reinforcement;

[0081] 2210, traction fixing part; 2220, bracket fixing part; 2230, first inner tube segment; 2240, second inner tube segment; 2250, bending skeleton; 2260, hot melt connecting claw;

[0082] 2310, wire exit port;

[0083] 2210a, first inner cavity hole; 2210b, first wire hanging part; 2220a, second inner cavity hole; 2220b, wire leading side hole; 2220c, bracket fixing part; 2220d, second wire hanging part;

[0084] 2251, skeleton tube; 2251a, bending assisting hollow hole; 2252, rotating unit;

[0085] 3100, rotation control; 3200, connecting thread. DETAILED DESCRIPTION

[0086] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in a number of different manners other than those described herein, and it is understood that similar modifications of this disclosure can be made by one skilled in the art, without departing from the spirit and scope of the present application, and therefore the present application is not limited to the specific embodiments disclosed below.

[0087] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0088] In addition, the terms "first", "second" are only for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "a plurality of" is at least two, for example, two, three, etc., unless otherwise specifically limited.

[0089] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0090] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0091] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0092] To more clearly describe the structure of the delivery assembly, the term "distal end" is defined herein as the end furthest from the operator during the surgical procedure, and "proximal end" as the end closest to the operator during the surgical procedure. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0093] See Figures 1 to 3 As shown, one embodiment of the present invention provides a delivery assembly, which includes an outer conduit 1000, an inner conduit 2000, and a traction wire 2200b. The outer conduit 1000 has an axial inner cavity, and the inner conduit 2000 has a guiding inner cavity 2100a. The inner conduit 2000 is movably fitted within the axial inner cavity of the outer conduit 1000. The axial direction refers to the direction of the central axis of the outer conduit 1000 or the inner conduit 2000, i.e.Figure 2 The left and right directions shown are the circumferential direction, i.e. the direction around the central axis of the outer catheter 1000 or the inner catheter 2000. The inner catheter 2000 includes a push inner tube segment 2100 and a curved inner tube segment 2200 in the axial direction, the distal end of the push inner tube segment 2100 is connected to the proximal end of the curved inner tube segment 2200, the tube diameter of the curved inner tube segment 2200 is greater than the tube diameter of the push inner tube segment 2100, the delivery assembly includes a guide wire 2100b for being arranged in the guide inner cavity 2100a of the inner catheter 2000, and the traction wire 2200b is connected to the curved inner tube segment 2200.

[0094] The inner catheter 2000 is movably assembled in the axial inner cavity of the outer catheter 1000, mainly embodied in that the inner catheter 2000 can move axially in the axial inner cavity of the outer catheter 1000 relative to the outer catheter 1000, and the stent body D with the valve C can be assembled between the inner catheter 2000 and the outer catheter 1000. In one embodiment, the outer catheter 1000 can also include a push outer tube segment 1100 and a curved outer tube segment 1200 in the axial direction, the distal end of the push outer tube segment 1100 is connected to the proximal end of the curved outer tube segment 1200, at this time, the push outer tube segment 1100 of the outer catheter 1000 and the push inner tube segment 2100 of the inner catheter 2000 can form structural correspondence and matching, and the curved outer tube segment 1200 of the outer catheter 1000 and the curved inner tube segment 2200 of the inner catheter 2000 can form structural correspondence and matching, specifically, the length of the curved outer tube segment 1200 can be adjusted according to the bending control requirement, and the stent body D with the valve C can be assembled between the curved inner tube segment 2200 of the inner catheter 2000 and the curved outer tube segment 1200 of the outer catheter 1000.

[0095] Continuing to refer to Figure 1 As shown, after the connection position of the traction wire 2200b and the curved inner tube segment 2200 is determined, pulling the traction wire 2200b can form pulling on the corresponding position of the curved inner tube segment 2200, i.e. when the traction wire 2200b applies the force F1, it promotes the curved inner tube segment 2200 to form a curve, because the tube diameter of the curved inner tube segment 2200 is greater than the tube diameter of the push inner tube segment 2100, so when the traction wire 2200b pulls the curved inner tube segment 2200 with a larger tube diameter, it can generate a larger moment perpendicular to the cross section of the curved inner tube segment 2200, thereby achieving a good bending control effect, i.e. by increasing the outer diameter of the curved inner tube segment 2200, it promotes the inner catheter 2000 to generate a larger bending control angle.

[0096] The traction wire 2200b can be connected with any position of the curved inner tube segment 2200, for example, in one embodiment, the distal end of the traction wire 2200b is connected with the distal end of the curved inner tube segment 2200, the distal end of the traction wire 2200b is connected with the middle of the curved inner tube segment 2200, etc. Those skilled in the art can adjust the connection position of the traction wire 2200b and the curved inner tube segment 2200 according to the bending control requirement of the curved inner tube segment 2200, which is not limited here.

[0097] The traction wire 2200b can be directly or indirectly connected with the curved inner tube segment 2200, for example, the traction wire 2200b is connected with the curved inner tube segment 2200 by binding, winding, welding, etc. Alternatively, the curved inner tube segment 2200 is provided with a traction fixing member 2210, and the traction wire 2200b is connected with the curved inner tube segment 2200 through the traction fixing member 2210. The position of the traction fixing member 2210 on the curved inner tube segment 2200 is the connection position of the traction wire 2200b on the curved inner tube segment 2200.

[0098] After the traction wire 2200b is connected with the curved inner tube segment 2200, the proximal end of the traction wire 2200b can extend proximally along the axial direction, for example, the traction wire 2200b extends proximally along the axial direction along the gap between the inner catheter 2000 and the outer catheter 1000, or the inner catheter 2000 has a traction lumen 2200a, and the traction wire 2200b can extend proximally along the axial direction through the traction lumen 2200a of the inner catheter 2000. Since the traction wire 2200b is distributed in the inner catheter 2000, the distal bending of the delivery assembly can be achieved by controlling the traction wire 2200b, and the mutual axial movement between the inner catheter 2000 and the outer catheter 1000, i.e. the pushing and retracting of the outer catheter 1000 relative to the inner catheter 2000, can be not affected. The pushing and retracting of the outer catheter 1000 can control the release and retraction of the stent body D with the valve C. Specifically, the pushing and retracting of the outer catheter 1000 can be controlled by a button, which is not limited here.

[0099] Since the tube diameter of the curved inner tube segment 2200 is larger than that of the pushing inner tube segment 2100, the connection position of the curved inner tube segment 2200 and the pushing inner tube segment 2100 can be transitioned by variable diameter or stepped, for example, the proximal end of the curved inner tube segment 2200 has a variable diameter segment, and the variable diameter segment of the curved inner tube segment 2200 is connected to the distal end of the pushing inner tube segment 2100, wherein the tube diameter of the variable diameter segment of the curved inner tube segment 2200 gradually decreases from the distal end to the proximal end, thereby forming a transition connection between the curved inner tube segment 2200 and the pushing inner tube segment 2100 with different tube diameters. Moreover, the pulling inner lumen 2200a passing through the curved inner tube segment 2200 and the pushing inner tube segment 2100 also changes the radial distance from the central axis of the inner catheter 2000 as the tube diameters of the curved inner tube segment 2200 and the pushing inner tube segment 2100 change, and continues to refer to Figure 1 As shown, along the direction of the pulling force F1 of the pulling wire 2200b, the pulling inner lumen 2200a and the pulling wire 2200b located therein have a radial distance L2 and a radial distance L1 in the curved inner tube segment 2200 and the pushing inner tube segment 2100, respectively, and L2 is less than L1.

[0100] The curved outer tube segment 1200 can be composed of multiple layers of different materials, for example, the curved outer tube segment 1200 can have a polymer outer layer, a polymer inner layer, and a metal cutting reinforcement layer between the polymer outer layer and the polymer inner layer, the polymer outer layer uses flexible materials such as polyurethane, polyamide polyether copolymer, the polymer inner layer uses flexible materials such as polytetrafluoroethylene, polyurethane or polyamide polyether copolymer, and the curved outer tube segment 1200 needs to have properties such as easy bending, pressure resistance, and good hoop stiffness, therefore, the metal cutting reinforcement layer can use nickel-titanium alloy material with good resilience. Those skilled in the art can prepare the curved outer tube segment 1200 according to the needs, which is not limited here.

[0101] Referring to Figures 4 to 6 As shown, in one embodiment, the metal cutting reinforcement layer has cutting grooves cut out, the number of cutting grooves can be two or more, and the cutting grooves are distributed along the axial direction of the curved outer tube segment 1200, referring to Figure 5 As shown, the cutting grooves 1210 can have an arc structure around the curved outer tube segment 1200, and a plurality of cutting grooves 1210 are arranged in parallel and symmetrically distributed on both sides of the curved outer tube segment 1200, and the axial distribution of the cutting grooves 1210 has good pressure resistance, and the plane perpendicular to the cutting grooves 1210 has excellent bending performance.

[0102] Referring to Figure 6As shown, the distal end of the curved outer tube segment 1200 has a deformation segment 1220, which has a straight cylinder state and a tapered cylinder state, and the deformation segment 1220 is used to change between the straight cylinder state and the tapered cylinder state, so as to form a horn-shaped mouth with a guiding function, i.e. the tapered cylinder state, during the stent body D recovery process, and to restore the original state, i.e. the straight cylinder state, after the recovery is completed. The deformation segment 1220 can be constructed in various structural forms, for example Figure 6 As shown, the deformation segment 1220 is a plurality of straight lines circumferentially surrounding the distal end of the curved outer tube segment 1200, one end of the plurality of straight lines is connected to the distal end of the curved outer tube segment 1200, and is constructed as a fixed tube diameter state, and the other end of the plurality of straight lines is in a cantilever state towards the distal end, so that it can be radially inwardly collapsed due to radial stress during the stent body D recovery process, so that the deformation segment 1220 constructed by the plurality of straight lines presents a tapered cylinder state, and restores to a straight cylinder state when the stress is removed.

[0103] The proximal end of the curved outer tube segment 1200 has a variable diameter segment, and the variable diameter segment of the curved outer tube segment 1200 is connected to the distal end of the push outer tube segment 1100, wherein the tube diameter of the variable diameter segment of the curved outer tube segment 1200 gradually decreases from the distal end to the proximal end, and the lengths of the curved outer tube segment 1200 and the curved inner tube segment 2200 can be designed to match, for example, the variable diameter segment of the proximal end of the curved inner tube segment 2200 can terminate at the variable diameter segment of the proximal end of the curved outer tube segment 1200.

[0104] The push outer tube segment 1100 can be composed of multiple layers of different materials, for example, the push outer tube segment 1100 can be a composite tube composed of a polymer outer layer material, a polymer inner layer material, an outer tube braided layer, and a distal end metal ring. The polymer outer layer material can use polyamide, polyamide polyether copolymer, etc., the polymer inner layer material can use polytetrafluoroethylene, high-density polyethylene, polyamide, or polyamide polyether, etc., the outer tube braided layer is located between the polymer outer layer material and the polymer inner layer material, and the outer tube braided layer can be woven with metal reinforcing wires, and the push outer tube segment 1100 can also be provided with a cutting pattern 1210 such as a reinforcing rib on the symmetrical double sides along the axial direction, the purpose is to strengthen the structure of the push outer tube segment 1100, and the double-sided axial reinforcing rib can have good bending performance in the direction perpendicular to the reinforcing rib plane, and has good compression resistance.

[0105] In one embodiment, the distal end of the push outer tube segment 1100 and the proximal end of the curved outer tube segment 1200 can be connected by heat melting or other connection methods, and a connection ring 1300 can be arranged between the distal end of the push outer tube segment 1100 and the proximal end of the curved outer tube segment 1200. The connection ring 1300 can be sleeved on the connection position of the distal end of the push outer tube segment 1100 and the proximal end of the curved outer tube segment 1200 and the vicinity of the connection position. The connection ring 1300 can be used to enhance the coupling and sealing of the connection position of the distal end of the push outer tube segment 1100 and the proximal end of the curved outer tube segment 1200.

[0106] The push outer tube segment 1100 is provided with an outer tube reinforcing member 1110, which can be a reinforcing rib or other component. The number of reinforcing ribs can be two or more, and the reinforcing ribs can be arranged axially on the push outer tube segment 1100. The purpose is to strengthen the structure of the push outer tube segment 1100. The connection ring 1300 can be made of metal. The distal end of the push outer tube segment 1100 and the connection ring 1300 can be connected by welding. The connection ring 1300 at the distal end of the push outer tube segment 1100 can be welded to the outer tube reinforcing member 1110. A welding position 1110a is formed between the connection ring 1300 and the outer tube reinforcing member 1110. The outer tube reinforcing member 1110 can provide better support to ensure the stability of the stent body D during release and recovery. During the recovery of the stent body D, the push inner tube segment 2100 can avoid bearing a large pressure, and the reinforcing rib can avoid sliding out of the end to suddenly reduce the pressure resistance.

[0107] The curved inner tube segment 2200 includes a curved skeleton 2250 and a curved protective layer. The curved skeleton 2250 is arranged in the curved protective layer. The curved skeleton 2250 is used as the internal basic skeleton of the curved inner tube segment 2200, and the curved protective layer is used to wrap and protect the basic skeleton. Figure 7 In one embodiment, the curved skeleton 2250 includes a skeleton tube 2251. The outer wall of the skeleton tube 2251 is provided with a bending-assisting hollow hole 2251a. The bending-assisting hollow hole 2251a is a linear hole. The bending-assisting hollow hole 2251a is arranged along the circumference of the skeleton tube 2251. The bending-assisting hollow hole 2251a can surround at least a portion of the circumference of the skeleton tube 2251. The number of the bending-assisting hollow holes 2251a is multiple. The multiple bending-assisting hollow holes 2251a are distributed along the axis of the skeleton tube 2251. The multiple bending-assisting hollow holes 2251a can be distributed on the symmetrical two sides of the skeleton tube 2251. The bending-assisting hollow holes 2251a on different sides can be distributed axially in a staggered manner. The skilled person can arrange the bending-assisting hollow holes 2251a according to the requirements, which are not limited herein.

[0108] In one of the embodiments, the bending protection layer can include a bending inner protective layer and a bending outer protective layer, the bending outer protective layer is arranged on the outer surface of the skeleton tube 2251, and the bending inner protective layer is arranged on the inner surface of the skeleton tube 2251, thereby wrapping the skeleton tube 2251, the bending outer protective layer can be made of a polymer flexible material such as polyurethane, polyamide polyether copolymer, etc., the bending inner protective layer can be made of a polymer such as polytetrafluoroethylene, high-density polyethylene, polyurethane, polyamide polyether copolymer, etc., and the skeleton tube 2251 can be made of a metal material and is constructed by laser cutting to have the bending assisting hollow hole 2251a.

[0109] Referring to Figure 8 In one of the embodiments, the bending skeleton 2250 includes a plurality of rotating unit elements 2252, the plurality of rotating unit elements 2252 are distributed along the axial direction of the bending skeleton 2250 and are movably connected between adjacent rotating unit elements 2252, for example, the movable connection can be achieved by a hinge type universal rotation or a fixed shaft rotation type, etc., wherein the adjacent rotating unit elements 2252 can be connected by a fixed shaft rotation, and the plurality of rotating shafts between the plurality of rotating unit elements 2252 are parallel to each other. The plurality of rotating unit elements 2252 of the skeleton tube 2251 can be constructed by laser cutting, or the rotating unit element 2252 can also be a snake bone element, and the skeleton tube 2251 is constructed by a riveted snake bone structure, the riveted snake bone structure has super strong flexibility, the traction wire 2200b uniformly acts along the skeleton tube 2251, which can greatly reduce the bending modulus of the skeleton tube 2251, and the riveted snake bone structure can provide strong tensile performance. The bending protection layer can be made of a polymer flexible material such as polyurethane, polyamide polyether copolymer, etc., and the bending protection layer can be directly arranged on the outer surface of the bending skeleton 2250.

[0110] Referring to Figure 9 In one of the embodiments, the push inner tube segment 2100 includes an inner tube segment inner layer 2110 and an inner tube segment outer layer 2120, an inner tube braided layer 2130 is arranged between the inner tube segment inner layer 2110 and the inner tube segment outer layer 2120, and the guide inner cavity 2100a and the traction inner cavity 2200a are opened in the inner tube segment inner layer 2110, wherein, referring to Figure 9It can be known that the guide inner cavity 2100a and the traction inner cavity 2200a are offset from the central axis of the push inner tube segment 2100, and are arranged in a biased manner in the push inner tube segment 2100. Therefore, when the guide inner cavity 2100a and the traction inner cavity 2200a are arranged in the push inner tube segment 2100, the reasonable layout of the guide inner cavity 2100a and the traction inner cavity 2200a can reduce the wall thickness of the push inner tube segment 2100.

[0111] The inner tube segment outer layer 2120 can be made of polyamide or polyamide polyether copolymer, and the inner tube segment inner layer 2110 can be made of polytetrafluoroethylene material with self-lubricating effect. The inner tube segment inner layer 2110 is provided with an inner tube reinforcing member 2140 located between the guide inner cavity 2100a and the traction inner cavity 2200a.

[0112] The traction inner cavity 2200a is provided with a bending-resistant support tube 2200c. The bending-resistant support tube 2200c needs to have bending-resistant effect, so that the push inner tube segment 2100 with the traction inner cavity 2200a can withstand greater pressure and produce smaller deformation under the tension of the traction wire 2200b. For example, the bending-resistant support tube 2200c can be made of polytetrafluoroethylene or a dense compression spring tube, which is not limited herein. The dense compression spring tube can be located between the inner tube segment inner layer 2110 and the inner tube braided layer 2130, and the inner tube braided layer 2130 can play a role in hoop enhancement and restraint. When the traction wire 2200b is tensioned, the force along the axial direction of the inner catheter 2000 makes the inner catheter 2000 have a compression tendency. At this time, the dense compression spring tube plays a strong supporting role, so that the overall inner catheter 2000 produces very small deformation. After the inner catheter 2000 is bent, a force perpendicular to the axial direction is generated. The restraint effect of the inner tube braided layer 2130 can provide better hoop stiffness to avoid the circumferential deformation of the inner catheter 2000.

[0113] Referring to Figure 10As shown, the proximal end of the pushing inner tube segment 2100 is provided with a connecting inner tube segment 2300, the connecting inner tube segment 2300 is provided with a wire outlet 2310, the wire outlet 2310 is in communication with the pulling inner cavity 2200a, the proximal end of the pulling wire 2200b is led out from the wire outlet 2310, the distal end of the connecting inner tube segment 2300 is connected with the pushing inner tube segment 2100, the proximal end of the connecting inner tube segment 2300 is used to connect a holding component 3000 such as a handle, the proximal end of the connecting inner tube segment 2300 can be provided with a connecting thread 3200, the proximal end of the connecting inner tube segment 2300 is connected with the holding component 3000 by screwing, the holding component 3000 can be provided with a control member such as a rotary control member 3100, the rotary control member 3100 is used to control the tension and relaxation of the pulling wire 2200b.

[0114] The connecting inner tube segment 2300 can be a reinforcing tube made of metal material, the metal material has the effect of structural reinforcement, and the connecting inner tube segment 2300 can be divided into a first connecting segment 2300a and a second connecting segment 2300b, the proximal end of the first connecting segment 2300a is connected with the holding component 3000, the distal end of the first connecting segment 2300a is connected with the proximal end of the second connecting segment 2300b, the distal end of the second connecting segment 2300b is connected with the pushing inner tube segment 2100 by integral fusion, the integral fusion can ensure smooth passage of the whole control bending. At this time, the compact spring tube can extend from the distal end to the wire outlet 2310, ensuring smooth passage of the pulling wire 2200b in the axial direction.

[0115] Referring to Figures 11 to 21 As shown, the pulling fixing member 2210 is arranged at the distal end of the bending inner tube segment 2200, referring to Figure 13 As shown, the pulling fixing member 2210 is provided with a first inner cavity hole 2210a, the first inner cavity hole 2210a is in communication with the guide inner cavity 2100a, used for the guide wire 2100b to pass out from the distal end of the pulling fixing member 2210, the pulling fixing member 2210 is provided with a first wire hanging part 2210b, the pulling wire 2200b is connected with the first wire hanging part 2210b, and then connected at the distal end of the bending inner tube segment 2200.

[0116] The bending inner tube segment 2200 is provided with a bracket fixing member 2220, the bracket fixing member 2220 is arranged at the proximal end of the bending inner tube segment 2200, the bending inner tube segment 2200 is connected with the distal end of the pushing inner tube segment 2100 through the bracket fixing member 2220, referring to Figure 14As shown, the stent fixing member 2220 has a second inner lumen hole 2220a which communicates with the guide inner lumen 2100a for the guide wire 2100b to pass out from the proximal end of the stent fixing member 2220. The stent fixing member 2220 has a stent fixing portion 2220c which can be used to fix the stent body D with valve C, at this time the stent body D with valve C is assembled on the curved inner tube segment 2200 through the stent fixing member 2220.

[0117] The stent fixing portion 2220c can adopt various structural forms such as groove structure, through-hole structure, etc., as long as the stent fixing portion 2220c can realize the fixation of the stent body D with valve C, and the shape of the groove structure, through-hole structure can be matched according to the lug structure on the stent body D, etc. suitable for the stable assembly of the stent body D, when the stent body D with valve C is fixed, the stent fixing portion 2220c can limit the movement of the stent body D, for example, limit the movement of the stent body D in the circumferential direction, axial direction, etc. The stent fixing member 2220 has a wire side hole 2220b which communicates with the guide inner lumen 2200a, the proximal end of the guide wire 2200b can be extended to the proximal end by threading in the wire side hole 2220b, and finally introduced from the wire outlet 2310 opened on the connecting inner tube segment 2300.

[0118] As shown in Figure 15 and Figure 16 As shown, the traction fixing member 2210, the curved skeleton 2250, the stent fixing member 2220 and the hot melt connecting claw 2260 are welded and fixed, the guide wire 2200b can be connected with the traction fixing member 2210 in various ways, for example, the guide wire 2200b can be connected with the traction fixing member 2210 in a hanging way, the two guide wires 2200b pass through the curved skeleton 2250 to the proximal end, then pass through the wire side hole 2220b of the stent fixing member 2220, the hot melt connecting claw 2260 is wrapped with the distal end of the pushing inner tube segment 2100 to make hot melt connection, so that the wire side hole 2220b of the stent fixing member 2220 communicates with the guide inner lumen 2200a of the pushing inner tube segment 2000, and a complete guide inner lumen 2200a can be established.

[0119] As shown in Figures 17 to 21 indicates the state of the delivery assembly control bending over the arch, Figure 17 indicates the state of the delivery assembly control bending over the arch, Figure 18 indicates the state of the delivery assembly control bending over the arch, Figure 19 indicates the state of the delivery assembly control bending over the arch, Figure 20 indicates the state of the delivery assembly control bending over the arch, Figure 21The figure shows the state of the bending control release of the delivery assembly when passing through the arch. Therefore, a pulling force is applied to the traction wire 2200b towards the proximal end, and the bending inner tube segment 2200 and the bending outer tube segment 1200 will present a certain degree of bending, and the specific bending degree depends on the bending modulus and length of the bending inner tube segment 2200 and the bending outer tube segment 1200. At this time, the length of the bending inner tube segment 2200 and the bending outer tube segment 1200 can be ensured to be less than the distance between the traction fixing member 2210 and the valve C, and the performance of the valve C can be ensured.

[0120] After the inner tube 2000 and the outer tube 1000 of the delivery assembly are loaded with the stent body D with the valve C, when the inner tube 2000 and the outer tube 1000 pass through the aortic arch A (for example, the aortic arch, which is also applicable to other structures that need to pass through the arch), the bending inner tube segment 2200 and the bending outer tube segment 1200 can be pushed after a small angle bending control when encountering resistance. After the bending control, the distal end of the bending inner tube segment 2200 and the bending outer tube segment 1200 and the traction wire 2200b will be separated from the blood vessel wall, and it will be easier to push. If the inner tube 2000 and the outer tube 1000 do not perform bending control when passing through the aortic arch A, the inner tube 2000 and the outer tube 1000 will cross the annulus after passing through the aortic arch A, and the bending inner tube segment 2200 and the bending outer tube segment 1200 loaded with the stent body D will present a straight state as a whole. At this time, the bending inner tube segment 2200 and the bending outer tube segment 1200 will present a large angle with the annulus plane B, and at this time, when the stent body D is released, the stent body D may slide or tilt. After crossing the annulus, the inner tube 2000 and the outer tube 1000 are adjusted by bending control, and the inner tube 2000 and the outer tube 1000 will cause the stent body D, the guide wire 2100b, etc. to bend, and the inner tube 2000 and the outer tube 1000 are perpendicular to the annulus plane B. The specific angle of the bending control of the inner tube 2000 and the outer tube 1000 is adjusted according to the actual situation of different arches, which is not limited herein.

[0121] By adjusting the bending control of the inner tube 2000 and the outer tube 1000, the bending of the stent body D can be controlled, and the coaxial release can be achieved by adjusting the bending angle. The operator can control the outer tube 1000 to retract through the button of the handle, for example, by means of the cooperation of the motor and the button. The bending control mode of the inner tube 2000 can keep the stability of the bending type during the release process of the stent body D, and the stent body D always keeps the perpendicular state with the annulus plane B, which greatly ensures the stability of the release and the accuracy of the position of the stent body D. Moreover, the rear end of the stent body D is in a passive bending control state, and the stent body D needs to be completely released after the bending control is released and the anchoring stability is released. After the complete release, the bending control is released, and finally it is withdrawn from the body. This process does not affect the anchoring of the stent body D.

[0122] Referring to Figures 22 to 29As shown, the curved inner tube segment 2200 includes a first inner tube segment 2230 and a second inner tube segment 2240 in the axial direction, and the first inner tube segment 2230 and the second inner tube segment 2240 construct the curved inner tube segment 2200 into a two-segment structure, and the curved inner tube segment 2200 can also be divided into a three-segment structure and a structure of more than three segments, which is not limited herein. The distal end of the second inner tube segment 2240 is provided with a traction fixing member 2210, the traction fixing member 2210 has a first inner lumen hole 2210a, the first inner lumen hole 2210a is in communication with the guide inner lumen 2100a, and is used for the guide wire 2100b to pass out of the distal end of the traction fixing member 2210. The traction fixing member 2210 is provided with a first wire hanging part 2210b, and the traction wire 2200b is connected with the first wire hanging part 2210b, for example, by a connection mode of winding or welding, and then is connected to the distal end of the curved inner tube segment 2200.

[0123] The distal end of the first inner tube segment 2230 is connected with the proximal end of the second inner tube segment 2240 through the stent fixing member 2220, the stent fixing member 2220 has a second inner lumen hole 2220a, the second inner lumen hole 2220a is in communication with the guide inner lumen 2100a, and is used for the guide wire 2100b to pass out of the proximal end of the stent fixing member 2220. The stent fixing member 2220 has a stent fixing part 2220c, which can be used to fix the stent body D with the valve C, and at this time the stent body D with the valve C is assembled on the curved inner tube segment 2200 through the stent fixing member 2220 at the proximal end. The stent fixing member 2220 has a wire leading side hole 2220b, the wire leading side hole 2220b is in communication with the traction inner lumen 2200a, and the traction wire 2200b can be extended to the proximal end by being threaded in the wire leading side hole 2220b, and finally the proximal end of the traction wire 2200b is led out of the wire leading exit 2310 formed on the connecting inner tube segment 2300.

[0124] As shown in Figure 24 and Figure 25 The traction fixing member 2210, the curved skeleton 2250 of the second inner tube segment 2240, the stent fixing member 2220, the curved skeleton 2250 of the first inner tube segment 2230, and the hot melt connecting claw 2260 are welded and fixed, and the traction wire 2200b can be connected with the traction fixing member 2210 in various ways, for example, the traction wire 2200b can be connected with the traction fixing member 2210 in a hanging mode, one or more traction wires 2200b are threaded to the proximal end through the curved skeleton 2250 of the second inner tube segment 2240, and then are threaded through the wire leading side hole 2220b of the stent fixing member 2220, so that the wire leading side hole 2220b of the stent fixing member 2220 is in communication with the traction inner lumen 2200a of the push inner catheter 2000, and a complete traction inner lumen 2200a can be established.

[0125] Referring to Figures 26 to 29 As shown, when a pulling force is applied to the pulling wire 2200b towards the proximal end, the bending inner tube segment 2200 and the bending outer tube segment 1200 will present a certain degree of bending, and the specific bending degree depends on the bending modulus and length of the bending inner tube segment 2200 and the bending outer tube segment 1200. At this time, the length of the bending inner tube segment 2200 and the bending outer tube segment 1200 can be ensured to be less than the distance between the pulling fixing part 2210 and the valve C, so as to ensure that the valve C is not bent and is accurately positioned at the anchoring point F, thereby ensuring the performance of the valve C. The bending state of the bending inner tube segment 2200 and the bending outer tube segment 1200 can be in contact with or not in contact with the aortic arch, for example, when the bending inner tube segment 2200 and the bending outer tube segment 1200 are bent and are in relative contact and support with the aortic arch, referring to Figure 28 As shown, the bending outer tube segment 1200 can be supported by the aortic arch at a certain support point E, which is beneficial to the stable release of the stent body D to a certain extent.

[0126] After the stent body D with the valve C is loaded in the inner tube 2000 and the outer tube 1000 of the delivery assembly, when the inner tube 2000 and the outer tube 1000 pass through the aortic arch A, if resistance is encountered, the bending inner tube segment 2200 and the bending outer tube segment 1200 can be pushed after small-angle bending control, after bending control, the distal end of the bending inner tube segment 2200 and the bending outer tube segment 1200 and the pulling wire 2200b will be separated from the blood vessel wall of the aortic arch A, and it is easier to push. After crossing the annulus, the inner tube 2000 and the outer tube 1000 are adjusted by bending control, the inner tube 2000 and the outer tube 1000 will drive the stent body D, the guide wire 2100b and the like to bend, and the inner tube 2000 and the outer tube 1000 are in a vertical state with the annulus plane B, wherein the specific angle of bending control of the inner tube 2000 and the outer tube 1000 is adjusted and determined according to the actual situation of different arches, which is not limited here.

[0127] The bending inner tube segment 2200 is constructed as a two-segment structure in the axial direction by the first inner tube segment 2230 and the second inner tube segment 2240, which can make the operation more labor-saving and has a wide range of use. In specific operation, the outer tube 1000 can be controlled to retract along the retraction direction G by the button of the handle, the bending control mode of the inner tube 2000 can keep the bending stable during the release process, the stent body D always keeps a vertical state with the annulus plane B, which greatly ensures the release stability and position accuracy of the stent body D, and the rear end of the stent body D is in a passive bending state, the stent body D needs to be completely released after the bending control is released after anchoring and stabilizing, which does not affect the anchoring of the stent body D.

[0128] Referring to Figures 30 to 38As shown, the stent fixing member 2220 is arranged at the distal end of the curved inner tube segment 2200, the proximal end of the curved inner tube segment 2200 is directly connected with the pushing inner tube segment 2100, the stent fixing member 2220 has a second inner lumen hole 2220a, the second inner lumen hole 2220a is communicated with the guide inner lumen 2100a, and is used for the guide wire 2100b to pass out from the distal end of the stent fixing member 2220. The stent fixing member 2220 has a stent fixing part 2220c, which can be used to fix the stent body D with the valve C, at this time, the stent body D with the valve C does not cover the curved inner tube segment 2200. The stent fixing member 2220 has a second wire hanging part 2220d, the traction wire 2200b can be connected with the second wire hanging part 2220d, so that the stent fixing member 2220 has the functions of fixing the stent body D and connecting the traction wire 2200b at the distal end of the curved inner tube segment 2200.

[0129] As shown in Figure 33 and Figure 34 As shown, the stent fixing member 2220, the curved skeleton 2250 and the hot melt connecting claw 2260 are welded and fixed, the traction wire 2200b can be connected with the stent fixing member 2220 in various ways, for example, the traction wire 2200b can be connected with the stent fixing member 2220 in a hanging way, the two traction wires 2200b pass through the curved skeleton 2250 to the proximal end, then pass through the traction inner lumen 2200a of the pushing inner catheter 2000, and the hot melt connecting claw 2260 is covered with the hot melt connection with the distal end of the pushing inner tube segment 2100.

[0130] As shown in Figures 35 to 38 As shown, the traction wire 2200b is applied with a proximal end pulling force, the curved inner tube segment 2200 and the curved outer tube segment 1200 will be curved to a certain extent, and a stable support is formed by the support point E, and the specific curvature depends on the bending modulus and length of the curved inner tube segment 2200 and the curved outer tube segment 1200. At this time, it can be ensured that the length of the curved inner tube segment 2200 and the curved outer tube segment 1200 is less than the distance between the traction fixing member 2210 and the valve C, so that the valve C is not curved and is accurately positioned at the anchoring point F, thereby ensuring the performance of the valve C. The curved state of the curved inner tube segment 2200 and the curved outer tube segment 1200 can be in contact with or not in contact with the aortic arch, for example, when the curved inner tube segment 2200 and the curved outer tube segment 1200 are curved and are in contact with and supported by the aortic arch, as shown in Figure 38 As shown, the curved outer tube segment 1200 can be supported by the aortic arch at a certain support point E, which is beneficial to the stable release of the stent body D to a certain extent.

[0131] At this time, since the stent body D is fixed on the stent fixing member 2220 at the distal end, the bending control section of the curved inner tube section 2200 and the curved outer tube section 1200 cannot control the bending of the stent body D, and thus the straight section is relatively long, which is suitable for patients with long ascending aorta and can be adjusted to coaxial release. After the inner catheter 2000 and the outer catheter 1000 of the delivery assembly are loaded with the stent body D with the valve C, when the inner catheter 2000 and the outer catheter 1000 pass through the aortic arch A, if resistance is encountered, the curved inner tube section 2200 and the curved outer tube section 1200 can be pushed after being bent at a small angle, and after being bent, the distal end of the curved inner tube section 2200 and the curved outer tube section 1200 and the traction wire 2200b are separated from the tube wall, which is more easy to push, and makes the curved inner tube section 2200 and the curved outer tube section 1200 perpendicular to the annular plane B.

[0132] In specific operation, the outer catheter 1000 can be controlled to retract along the retraction direction G through the button of the handle, the inner catheter 2000 can keep the bending stable during the release process, the stent body D keeps perpendicular to the annular plane B, which greatly ensures the release stability and position accuracy of the stent body D, and the rear end of the stent body D is in a passive bending state, and the stent body D needs to be completely released after the bending force is removed after anchoring and stabilizing, which does not affect the anchoring of the stent body D.

[0133] The present application provides a delivery system, which comprises the delivery assembly and a handle, and the handle is drivingly connected with the delivery assembly, wherein the handle can be used to control the advancement and retreat of the outer catheter in the delivery assembly, the release and recovery of the stent, the bending of the inner catheter, etc., and a person skilled in the art can select the specific driving connection form of the handle and the delivery assembly according to the needs, which is not limited herein.

[0134] The technical features of the above-mentioned embodiments can be combined arbitrarily, and in order to make the description simple, all possible combinations of the technical features in the above-mentioned embodiments are not described, however, as long as the combinations of the technical features do not exist contradictory, they should be considered as the scope of the present application.

[0135] The above-mentioned embodiments only express several embodiments of the present application, the description is relatively specific and detailed, but it cannot be understood as the limitation of the scope of the patent. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A delivery assembly characterized by, The delivery assembly comprises: an outer catheter having an axial inner cavity; an inner catheter having a guide inner cavity, the inner catheter being movably assembled in the axial inner cavity of the outer catheter, wherein the inner catheter comprises an axial push inner tube segment and a curved inner tube segment in an axial direction, a distal end of the push inner tube segment being connected with a proximal end of the curved inner tube segment, a tube diameter of the curved inner tube segment being larger than a tube diameter of the push inner tube segment; a traction wire being connected with the curved inner tube segment; a stent body on which a valve is assembled, the stent body and the valve being configured to be assembled between the inner catheter and the outer catheter.

2. The delivery assembly of claim 1, wherein, a distal end of the traction wire being connected with a distal end of the curved inner tube segment; and / or, a traction fixing member being provided on the curved inner tube segment, the traction wire being connected with the curved inner tube segment through the traction fixing member; and / or, the inner catheter having a traction inner cavity, the traction wire being arranged in the traction inner cavity of the inner catheter; and / or, the proximal end of the curved inner tube segment having a variable diameter segment, the variable diameter segment of the curved inner tube segment being connected with the distal end of the push inner tube segment, wherein the variable diameter segment of the curved inner tube segment gradually decreases in tube diameter from the distal end to the proximal end.

3. The delivery assembly of claim 2, wherein, the traction fixing member having a first inner cavity hole, the first inner cavity hole being communicated with the guide inner cavity; and / or, a first wire hanging part being provided on the traction fixing member, the traction wire being connected with the first wire hanging part; and / or, a connecting inner tube segment being provided on the proximal end of the push inner tube segment, a wire leading-out hole being formed on the connecting inner tube segment, the wire leading-out hole being communicated with the traction inner cavity, a proximal end of the traction wire being led out from the wire leading-out hole; and / or, a bending-resistant support tube being provided in the traction inner cavity.

4. The delivery assembly of claim 1, wherein, a stent fixing member being provided on the curved inner tube segment.

5. The delivery assembly of claim 4, wherein, the stent fixing member being provided on the proximal end of the curved inner tube segment, the proximal end of the curved inner tube segment being connected with the distal end of the push inner tube segment through the stent fixing member; or, the stent fixing member being provided on the distal end of the curved inner tube segment; or, the curved inner tube segment comprising a first inner tube segment and a second inner tube segment in an axial direction, a distal end of the first inner tube segment being connected with a proximal end of the second inner tube segment through the stent fixing member.

6. The delivery assembly of claim 4, wherein, the stent fixing member having a second inner cavity hole, the second inner cavity hole being communicated with the guide inner cavity; and / or, the stent fixing member having a wire leading side hole, the wire leading side hole being communicated with the traction inner cavity; and / or, the stent fixing member having a stent fixing part.

7. The delivery assembly of claim 1, wherein, the curved inner tube segment comprising a curved skeleton and a curved protective layer, the curved skeleton being arranged in the curved protective layer.

8. The delivery assembly of claim 7, wherein, the curved skeleton comprising a skeleton tube, an outer wall of the skeleton tube being provided with a bending-assisting hollow hole; or, the curved skeleton comprising a plurality of rotating unit elements, the plurality of rotating unit elements being distributed along an axial direction of the curved skeleton and movably connected between adjacent rotating unit elements.

9. The delivery assembly of claim 8, wherein, the bending-assisting hollow hole being a linear hole, the bending-assisting hollow hole being arranged along a circumferential direction of the skeleton tube; and / or, a number of the bending-assisting hollow holes being a plurality, the plurality of bending-assisting hollow holes being distributed along the axial direction of the skeleton tube.

10. The delivery assembly of claim 8, wherein, The rotation units are connected in parallel with each other.

11. The delivery assembly of claim 8, wherein, The bending protection layer comprises a bending inner protection layer and a bending outer protection layer, the bending outer protection layer is arranged on the outer surface of the skeleton tube, and the bending inner protection layer is arranged on the inner surface of the skeleton tube. The bending protection layer is arranged on the outer surface of the bending skeleton.

12. The delivery assembly of claim 1, wherein, The push inner tube segment comprises an inner tube segment inner layer and an inner tube segment outer layer, and an inner tube braid layer is arranged between the inner tube segment inner layer and the inner tube segment outer layer.

13. The delivery assembly of claim 12, wherein, At least one of the inner tube segment inner layer and the inner tube braid layer is internally provided with an inner tube reinforcing member, and the inner tube reinforcing member is located between the guide inner cavity and the traction inner cavity.

14. The delivery assembly of claim 1, wherein, The outer catheter comprises a push outer tube segment and a bending outer tube segment in the axial direction, and the distal end of the push outer tube segment is connected with the proximal end of the bending outer tube segment.

15. The delivery assembly of claim 14, wherein, The distal end of the bending outer tube segment has a deformation segment, the deformation segment has a straight cylinder state and a tapered cylinder state, and the deformation segment is used for changing between the straight cylinder state and the tapered cylinder state. The proximal end of the bending outer tube segment has a variable diameter segment, the variable diameter segment of the bending outer tube segment is connected with the distal end of the push outer tube segment, and the diameter of the variable diameter segment of the bending outer tube segment gradually decreases from the distal end to the proximal end.

16. The delivery assembly of claim 15, wherein, The distal end of the push outer tube segment and the proximal end of the bending outer tube segment are provided with a connecting ring. The push outer tube segment is provided with an outer tube reinforcing member. The push outer tube segment is internally provided with an outer tube braid layer.

17. A delivery system characterized by, The delivery system comprises: The delivery assembly according to any one of claims 1-16; A handle, which is drivingly connected with the delivery assembly.

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