Stent system

By designing pre-embedded catheters and using specialized constraint structures, the problems of catheter deformation and stability in existing stent delivery systems have been solved, enabling stable superselection and safe release of catheters in complex lesions, thus improving surgical efficiency and safety.

CN121926718APending Publication Date: 2026-04-28LIFETECH SCI (SHENZHEN) CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
LIFETECH SCI (SHENZHEN) CO LTD
Filing Date
2025-12-15
Publication Date
2026-04-28

AI Technical Summary

Technical Problem

In existing stent delivery systems, the pre-embedded catheter is easily straightened or deformed after assembly, which increases the difficulty of superselective LSA, makes the branch catheter unstable in its fit with the main structure, causes excessive friction, and lacks an anti-dislodgement mechanism, affecting surgical efficiency and safety.

Method used

The design employs a pre-embedded conduit, comprising a main section, a pre-bent section, and a distal section. The pre-bent shape is protected by radial constraint force. Combined with the loading clutch component and limiting component, the stability of the conduit and the prevention of detachment are ensured, and frictional resistance is reduced.

Benefits of technology

It improves the superselective reliability of pre-embedded catheters, reduces surgical difficulty and time, enhances surgical efficiency and safety, and ensures the stability and smooth operation of catheters in complex lesions.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention provides a stent system which comprises a conveying handle, a sheath core assembly, an outer sheath tube, a self-expandable covered stent, a loading clutch component and an embedded catheter, the sheath core assembly is sleeved with the outer sheath tube, the far end of the sheath core assembly extends out of the tail end of the far end of the outer sheath tube, and the near end of the sheath core assembly and the near end of the outer sheath tube are both connected with the conveying handle; the covered stent can be compressed and loaded between the sheath core assembly at the far end and the outer sheath tube, the conveying handle comprises a branch connector, a first branch cavity is formed in the branch connector, and at least part of the loading clutch component can be inserted into the first branch cavity. The embedded catheter can be inserted into and penetrate through the loading clutch component to enter the conveying handle and then stretch into the covered stent loaded at the far end, and the embedded catheter penetrating through the loading clutch component can move front and back relative to the branch connector along the loading clutch component under the action of external force. The invention aims to at least improve the moving stability and smoothness of the embedded guide pipe.
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Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically a delivery system, and more specifically a stent system. Background Technology

[0002] In thoracic endovascular aortic repair (TEVAR), lesions involving the left subclavian artery (LSA) often require the use of a single-branch stent system to restore LSA blood flow, thereby ensuring cerebral blood supply. However, existing stent delivery systems for this technique have at least the following key problems: (1) Existing delivery systems are typically equipped with a pre-positioned catheter, whose core function is to pre-selectively enter the LSA before the main stent is released, establishing a stable channel for the subsequent introduction and release of branch stents. However, after assembly, the existing branch catheter is wrapped between components such as the stent and sheath, and is subjected to strong external pressure for a long time. The traditional assembly method does not fully consider how to protect the pre-molded shape of the catheter, resulting in its pre-positioned shape being straightened or undergoing irreversible deformation. When the delivery is in place, the sheath retracts, but the catheter cannot return to the expected shape, thus completely losing its "pre-positioned" meaning, seriously affecting the performance of its superselective LSA, greatly reducing the reliability of this function, increasing the difficulty and time of superselective operation, especially when dealing with lesions with tricky angles, which may require repeated attempts, prolonging the operation time, and increasing the risk of the operation and the operator's workload.

[0003] (2) The stability of the branch catheter and the main structure of the existing delivery system is insufficient. In the traditional design, the branch catheter needs to pass through multiple components of the delivery system (such as push rod, sheath, etc.), but there is no special constraint structure at the end of the delivery system handle. This causes the branch catheter to easily deviate axially or wobble radially during the superselection process (especially when moving back and forth or rotating for adjustment). This instability increases the difficulty of the operation. For example, when the tip of the branch catheter deviates from the opening of the left subclavian artery, it is necessary to make repeated adjustments and prolong the operation time. More seriously, the frictional resistance between the branch catheter and the delivery system components is large, which may cause wear on the surface coating of the branch catheter, or even cause the branch catheter to get stuck during the push process, affecting the smoothness of the operation.

[0004] In addition, existing delivery systems suffer from excessive friction during overselective LSA using branch catheters due to sealing performance considerations. While the delivery system employs an elastic seal, the excessive friction between the seal and the branch catheter causes the force applied by the operator when rotating or moving the branch catheter axially to counteract the friction between the catheter and the elastic seal. This results in a delayed feedback from the branch catheter tip, and the smaller diameter of the branch catheter further complicates the process during rotational overselective delivery.

[0005] In addition, the lack of a dislodgement prevention mechanism for branch catheters is another prominent issue. During stent deployment or adjustment of the branch catheter position, improper operation can lead to accidental dislodgement from the stent branch orifice. Once dislodgement occurs, the branch catheter must be reinserted and superselected again. Reinsertion not only prolongs the procedure time but may also cause intimal damage due to repeated manipulation (reselecting the branch orifice), increasing the risk of thrombosis and potentially leading to catheter failure in severe cases.

[0006] (3) For example Figure 1-1 As shown, in existing delivery systems, after the main stent B' is released into the target vessel A' and the branch catheter is superselectively inserted into the supra-arc branch, the rear handle is typically pushed forward and the entire delivery system is then withdrawn. However, this process causes a problem: the outer sheath 11' moves forward closer to the distal end of the sheath core assembly 10', which puts pressure on the protruding branch catheter 12'. When the delivery system is withdrawn under this pressure, the guidewire 13', which passes through the branch catheter 12' and enters the supra-arc branch, is affected. Figure 1-1 (The blue line in the diagram) will be removed along with the compressed branch catheter 12', thus losing the stable access for the subsequent introduction and release of the branch stent. This makes it impossible to proceed with the subsequent process of entering the supra-arc branch along the guidewire 13' and releasing the branch stent, resulting in surgical failure or the need to re-establish the access. Summary of the Invention

[0007] In view of the shortcomings of the prior art, the present invention aims to provide a conveying system to solve at least some of the above-mentioned technical problems.

[0008] To achieve this objective, the present invention adopts the following technical solution: This invention provides a delivery system comprising at least a delivery handle, a sheath core assembly, a self-expanding covered support, and a pre-embedded conduit. The proximal end of the sheath core assembly is connected to the delivery handle. The covered support is compressibly mounted on the distal end of the sheath core assembly. The covered support has a window area on its side for the pre-embedded conduit to pass through. The pre-embedded conduit includes a tube body comprising a main section, a distal section, and a pre-bent section connecting the distal section and the main section. The pre-bent section is deflected to one side relative to the axis of the main section and has radially opposite large and small bend sides. Under the loaded state with radial constraint applied, at least a portion of the small bend side is opposite to and abuts against the distal edge of the window area, the distal segment is located outside the covered stent, the main body segment passes through the inner cavity of the covered stent and its proximal end passes through the delivery handle, after the applied radial constraint is removed, the proximal end of the pre-embedded conduit is rotated, the pre-bent segment rotates accordingly and its large bend side is opposite to at least a portion of the covered stent, while the small bend side deflects toward the side away from the covered stent and the distal segment extends toward the side away from the covered stent.

[0009] The delivery system of this invention utilizes a pre-embedded conduit, comprising a connected main body section, a pre-bent section, and a distal section. The pre-bent section is offset to one side relative to the main body section. Under a loaded state with applied radial constraint, the small bend of the pre-bent section is aligned with the distal edge of the window area. This location is a natural gap, placing the pre-bent section within a "protected" space. Therefore, during subsequent pressing and sheathing processes, its shape is not destroyed by strong external pressure, maintaining its initial pre-bent state for a long period. This ensures that when the applied force is removed... After the radial constraint force is applied (e.g., upon release), by rotating the proximal end of the pre-embedded catheter, the pre-bent section rotates accordingly, causing its large bend side to be at least partially opposite to the covered stent, while its small bend side deflects away from the covered stent and its distal end extends away from the covered stent. This extension direction formed after rotation is more conducive to the pre-embedded catheter superselectively entering the supra-arc branch, thereby fundamentally ensuring the reliability and consistency of the core function of the delivery system, "pre-established channel," greatly reducing the difficulty of superselection, saving surgical time, and improving the efficiency and safety of the surgery.

[0010] The present invention also provides a delivery system, particularly a support system, comprising at least a delivery handle, a sheath core assembly, an outer sheath, a self-expanding covered support, a loading clutch component, and a pre-embedded conduit. The outer sheath is sleeved over the sheath core assembly, with the distal end of the sheath core assembly extending from the distal end of the outer sheath. The proximal ends of both the sheath core assembly and the outer sheath are connected to the delivery handle. The covered support can be compressed and loaded between the distal sheath core assembly and the outer sheath. The delivery handle includes a branch joint with a first branch cavity. At least a portion of the loading clutch component can be inserted into the first branch cavity. The pre-embedded conduit can be inserted and pass through the loading clutch component, enter the delivery handle, and extend into the distal covered support. The pre-embedded conduit passing through the loading clutch component can move back and forth relative to the branch joint under external force along the loading clutch component.

[0011] The stent system of this invention utilizes a specialized constraint structure with a loading clutch component that can be inserted into the delivery handle. The pre-embedded catheter passes through this loading clutch component, which provides support and constraint, preventing offset or radial swaying during the pre-embedded catheter's forward and backward movement or rotational adjustment. This ensures stability and reduces frictional resistance with the delivery handle, minimizing wear on the pre-embedded catheter's surface coating. Furthermore, it facilitates smoother catheter movement and operation, reducing surgical risks and saving surgical time. The loading clutch component, acting as a clutch, can be switched between engaged and disengaged states. The operator can move the loading clutch component as needed, allowing it to engage with the elastic seal or disengage, enabling movement or rotation of the pre-embedded catheter with minimal external force and allowing for easy fixation of its position and shape. A further design prevents branch catheters from accidentally dislodging from the stent branch opening.

[0012] The present invention also provides a conveying system, the conveying system comprising at least a conveying handle, a sheath core assembly, an outer sheath tube, and a limiting assembly. The conveying handle includes a handle comprising a front handle and a rear handle axially opposite each other. The rear handle is movable back and forth relative to the front handle to move closer to or further away from the front handle. The outer sheath tube is sleeved over the sheath core assembly, and the distal end of the sheath core assembly extends from the distal end of the outer sheath tube. The proximal ends of both the outer sheath tube and the sheath core assembly are connected to the conveying handle, and at least a portion of the sheath core assembly is fixed relative to the front handle. The outer sheath tube is connected to the rear handle. Furthermore, the outer sheath can move axially with the movement of the rear handle. The rear handle and the front handle have a minimum distance W0 in the initial state and a movement distance W greater than the minimum distance W0 formed after the rear handle is moved. The movement distance W includes a preset limiting distance Wmax. The limiting component is disposed on the front handle and / or the rear handle. The limiting component is configured such that when the movement distance W of the rear handle is moved backward is greater than or equal to the limiting distance Wmax, the limiting component at least partially extends into the gap between the rear handle and the front handle to form an axial limit.

[0013] The conveying system of the present invention has a limiting component on the conveying handle. When the rear handle of the conveying handle is opened, the limiting component will be placed between the front handle and the rear handle. After the film-coating bracket is released, the front handle and the rear handle of the conveying handle will merge. The two will not completely merge, so the tip head and the outer sheath of the sheath core assembly of the conveying system will not clamp the guide wire. When the conveying system is withdrawn, it will not affect the guide wire and will not cause the guide wire channel to fail. Attached Figure Description

[0014] The above and other objects, features, and advantages of the present invention will become clearer through a more detailed description of the preferred embodiments illustrated in the accompanying drawings. The same reference numerals denote the same parts throughout the drawings, and the drawings are not intentionally drawn to scale with actual dimensions; the focus is on illustrating the gist of this application.

[0015] Figure 1-1 A partial schematic diagram of the existing conveying system when the support frame is withdrawn after being transported. Figure 1 This is a schematic diagram of the structure of an exemplary conveying system of the present invention under one state; Figure 1a for Figure 1 A magnified view of part A1 in the middle; Figure 1b for Figure 1 A magnified view of part A2 in the middle; Figure 2 This is a schematic diagram of the structure of the exemplary conveying system of the present invention in another state; Figure 2a for Figure 2 A magnified view of a portion of section B1; Figure 2b for Figure 2 A magnified view of part B2 in the middle section; Figure 2c for Figure 2 A magnified view of a portion of section B3; Figure 2d For rotation Figure 2c A schematic diagram showing the local state of the proximal end of the pre-embedded conduit and the distal end of the pre-embedded conduit. Figure 3 This is a schematic diagram of the structure of another state of the exemplary conveying system of the present invention; Figure 3a for Figure 3 A magnified view of a portion of C1; Figure 3b for Figure 3 A magnified view of a portion of section C2; Figure 4 This is a schematic diagram of the structure of the pre-embedded conduit, which is an example of the present invention; Figure 4a for Figure 4 A schematic diagram of the distal partial structure of the pre-embedded conduit; Figure 4b for Figure 4 An exemplary layered structure diagram of a pre-embedded conduit; Figure 5 This is a schematic diagram of the structure of the exemplary conveying system of the present invention after the applied radial constraint force has been removed; Figure 6 This is a side view of the film-coated support in one state of an exemplary delivery system of the present invention; wherein, Figure 7 for Figure 6 A schematic diagram of the three-dimensional structure; Figure 8 This is a side view of another configuration of the film-coated support in the exemplary delivery system of the present invention; wherein, Figure 9 for Figure 8 A schematic diagram of the three-dimensional structure; Figure 10 This is a top view of the film-coated support structure in an exemplary conveying system of the present invention; Figure 11 A partial structural diagram showing the preloaded state of the branch support of the covered stent, which is tilted relative to the main stent. Figure 12 This is a schematic diagram of the local internal structure of the covered scaffold when it is constrained by the restraint assembly and subjected to radial constraint force. Figure 12a This is a partial side view of the covered scaffold when it is constrained by the restraint assembly and subjected to radial restraint force. Figure 13 This is a partial side view of the structure of the covered scaffold when it is constrained by the restraint assembly but without radial restraint force applied. Figure 14 This is a partial top view of the structure of the covered scaffold constrained by the restraint assembly; Figure 15 A schematic diagram of the structure of the unfolded restraint component; Figure 16 A schematic diagram showing the connection between the branch joint of the delivery handle and the loading clutch component and the pre-embedded conduit; Figure 16a This is a schematic diagram of the conveying system in its first state; in this diagram, the loading clutch component and the elastic seal are engaged. Figure 16b This is a schematic diagram of the conveying system in its second state; in this state, the loading clutch component and the elastic seal are separated. Figure 17 This is a schematic diagram of the internal structure of a branch connector; Figure 17a This is a side view of the branch connector. Figure 17b A schematic diagram of a structure in which an elastic seal is placed inside a branch joint; Figure 17c A schematic diagram of a half-section structure in which an elastic seal is placed inside a branch joint; Figure 17d A schematic diagram of a structure with a baffle plate inside an elastic seal; Figure 18 A schematic diagram of the structure for mounting the clutch mechanism; Figure 18a A half-section structural diagram of the structure for mounting the clutch mechanism; Figure 19 A structural diagram illustrating a configuration where a branch joint and a loading clutch component are connected to a tensioning member. Figure 20 A schematic diagram of another configuration for connecting the branch joint and loading clutch components of the traction component; Figure 21 This is a schematic diagram of the limit component. Figure 22 This is a partial structural diagram of the push rod; Figure 23 This is a partial structural diagram of the inner sheath core of the sheath core assembly; Figure 24 A three-dimensional structural diagram of the pull-out opening; Figure 24a This is a schematic diagram of a half-section of the drawbar opening; Figure 24b This is a top view of the guy wire opening structure. Figures 25a-25d This is a schematic diagram illustrating the operation process of an exemplary conveying system of the present invention. Detailed Implementation

[0016] To facilitate understanding of the present invention, a more comprehensive description will be given below with reference to the accompanying drawings.

[0017] It should be noted that when a component is considered to be "connected" to another component, it can be directly connected to and integrated with the other component, or there may be an intervening component present. The terms "mounted," "one end," "the other end," and similar expressions used in this document are for illustrative purposes only.

[0018] 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. 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. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0019] In this application, the end closer to the operator is defined as the proximal end, and the end farther from the operator is defined as the distal end. That is, based on... Figure 1 For example, the left side is the distal end, and the right side is the proximal end.

[0020] Please see Figures 1-3 This invention provides an exemplary delivery system 100 for delivering and releasing an implant to a target location. Exemplarily, the implant may be a covered stent, an occluder, a valve stent, etc. It should be understood that when the delivery system is specified to include a covered stent in the following embodiments, the implant is a covered stent, and the delivery system is used to deliver the covered stent; therefore, the corresponding delivery system is a stent system. When the delivery system is not specified to include a covered stent in the embodiments, the delivered implant is not limited to a covered stent.

[0021] To address at least some of the technical problems in the background art, the present invention will employ the following embodiments. It should be noted that the following embodiments can be arbitrarily combined without structural conflict to solve more than one technical problem.

[0022] Please see Figure 1 , Figure 1a , Figure 1b , Figure 2 , Figure 2a , Figure 2b , Figure 2c , Figure 2d as well as Figure 4 and Figure 4aIn order to at least solve the problem mentioned in the background section that the pre-molded shape of existing pre-embedded catheters cannot be maintained after assembly, resulting in increased difficulty, prolonged operation time, and increased surgical risk during pre-embedded catheter over-selection (i.e., the technical problem described in point (1) of the background section), this embodiment provides a delivery system 100, which includes at least a delivery handle 10, a sheath core assembly 20, a self-expanding covered stent 60, and a pre-embedded catheter 50. In the exemplary embodiment of the present invention, if the implant is limited to a covered stent 60, then the delivery system 100 is a stent system, that is, in this embodiment, the stent system includes at least a delivery handle 10, a sheath core assembly 20, a self-expanding covered stent 60, and a pre-embedded catheter 50. For ease of description, the term delivery system will be used uniformly below. It should be understood that when a covered stent 60 is present, the delivery system 100 is a stent system. The proximal end of the sheath core assembly 20 is connected to the delivery handle 10, as shown below. Figure 2b The covered stent 60 can be compressed and mounted on the distal end of the sheath core assembly 20. The side of the covered stent 60 is provided with a window area 60a through which the pre-embedded catheter 50 can pass. Figure 4 and Figure 4a The pre-embedded conduit 50 includes a pipe body 50a, which includes a main body segment 51, a distal segment 53, and a pre-bent segment 52 connecting the distal segment 53 and the main body segment 51. The pre-bent segment 52 is deflected to one side relative to the axis of the main body segment 51, and has radially opposite large bending sides 52a and small bending sides 52b, such as... Figure 2b As shown, under the loaded state with radial constraint force applied, at least a portion of the small curved side 52b is opposite to and abuts against the distal side edge 60a1 of the window area 60a. The distal segment 53 is located outside the covering support 60. After the main body segment 51 passes through the inner cavity of the covering support 60, its proximal end passes through the delivery handle 10. Figure 2c As shown, after removing the applied radial constraint force, rotating the proximal end of the pre-embedded conduit 50 reveals the following: Figure 2d As shown, the pre-bent section 52 rotates such that its large bend side 52a is at least partially opposite to the covered support 60, while its small bend side 52b deflects away from the covered support 60 and its distal section 53 extends away from the covered support 60. Figure 2b and Figure 2d The red line indicates the pre-bending segment 52, the blue line indicates the distal segment 53, and the magenta line indicates the main segment 51. It should be noted that since the pre-bending segment 52 has a certain extension length, when it passes through the window area, it covers the window and a portion of the area between the front and rear sides of the window. Therefore, the "distal edge of the window area" mentioned in this application refers to the window and a portion of the area between the front and rear sides of the window.

[0023] In this embodiment, by aligning the small bend side 52b of the pre-bent section 52 of the pre-embedded conduit 50 with the distal edge of the window area 60a under a loaded state with radial constraint applied, this position is a natural gap area, placing the pre-bent section 52 of the pre-embedded conduit 50 within a "protected" space. Therefore, during subsequent pressing and sheathing processes, its shape will not be destroyed by strong external pressure, and it can maintain its initial pre-bent state for a long time. This allows the pre-bent section 52 to be placed within a "protected" space after the applied radial constraint is removed (e.g., during release), by rotating the proximal end of the pre-embedded conduit 50... The pre-bent section 52 rotates, causing its large bend side 52a to be at least partially opposite to the covered stent 60, while its small bend side 52b deflects away from the covered stent 60 and its distal section 53 extends away from the covered stent 60. This extension direction formed after rotation is more conducive to the pre-embedded catheter 50 superselectively entering the supra-arc branch, thereby fundamentally ensuring the reliability and consistency of the core function of the delivery system 100 "pre-established channel", greatly reducing the difficulty of superselection, saving surgical time, and improving the efficiency and safety of the operation.

[0024] The proximal end of the sheath core assembly 20 is connected to the delivery handle 10, and the distal end of the sheath core assembly 20 extends beyond the distal end of the delivery handle 10 and toward a side opposite to the delivery handle 10. Generally, the sheath core assembly 20 has a preset axial extension length, which can be set according to specific needs. The implant can be loaded onto the distal end of the sheath core assembly 20, thereby being delivered and released to the target location.

[0025] For example, the sheath core assembly 20 includes an inner sheath core and an outer sheath core. The outer sheath core is sleeved outside the inner sheath core, and the distal end of the inner sheath core is located on the distal side relative to the distal end of the inner sheath core, that is, a portion of the distal end of the inner sheath core extends beyond the distal end of the inner sheath core. The outer sheath core can move axially back and forth relative to the inner sheath core. Specifically, the inner sheath core includes an inner sheath core tube and a tip head fixed to the distal end of the inner sheath core tube. The outer sheath core includes an outer sheath core tube and an anchoring member fixed to the distal end of the outer sheath core tube. A groove is provided on the proximal side of the tip head, and the distal side of the anchoring member extends into the groove. The specific structure of the sheath core assembly in this invention will not be described in detail here.

[0026] Please continue reading. Figures 1-3 In one embodiment, the delivery system 100 further includes an outer sheath 40, which is sleeved over the sheath core assembly 20, with the distal end of the sheath core assembly 20 extending from the distal end of the outer sheath 40. The proximal end of the outer sheath 40 is connected to the delivery handle 10, and the outer sheath 40 can move axially back and forth relative to the sheath core assembly 20 under external force. It should be noted that when the delivery system 100 is not equipped with an outer sheath 40, the delivery system 100 can be applied to surgical procedures, for example, by opening the chest and cutting the vascular tissue, and then placing the delivery system 100 without an outer sheath 40 through the incision, thereby realizing the delivery and release of the implant.

[0027] in, Figure 1 and Figure 2 The diagram shows the structure of the conveying system 100 including the outer sheath 40; combined with Figure 1 and Figure 1a , Figure 1a The diagram shows the front handle 11 and rear handle 12 of the delivery handle 10 as close to each other as possible, at which point the distal end of the outer sheath 40 abuts against the proximal end of the tip of the sheath core assembly 20, or the distal portion of the outer sheath 40 covers the tip of the sheath core assembly 20 (e.g., Figure 1b At this point, the covered support 60 is completely housed within the loading area between the outer sheath 40 and the sheath core assembly 20 (this state can be understood as a loading state with radial constraint applied). Figure 2 and Figure 2a , Figure 2a The diagram shows the rear handle 12 of the delivery handle 10 being moved a certain distance relative to the front handle 11, thereby causing the outer sheath tube 40 to retract (which can be understood as removing the applied radial constraint force). At this time, the film-coated support 60 loaded in the loading area between the outer sheath tube 40 and the sheath core assembly 20 is exposed (see reference). Figure 2b It should be noted that the "loading state with radial constraint force" described in this invention refers to the state in which the pre-embedded conduit 50 of the delivery system 100 passes through the window area 60a, and at least a portion of the small bend side 52b of the pre-bent section 52 is opposite to the distal edge of the window area 60a, and at the same time, the pre-embedded conduit 50 is subjected to radial pressure and rests against the distal edge of the window area 60a. This can also be understood as the state during implant delivery. Because the pre-embedded conduit 50 itself has a certain degree of rigidity and support, and its pre-bent section 52 is formed after pre-bending, when the pre-embedded conduit 50 only passes through the window area 60a without radial constraint force (i.e., without pressure), it may exhibit the following under its own support: Figure 5 As shown, when it is slightly upturned, at least a portion of the small curved side 52b is opposite to the distal side edge 60a1 of the window area 60a, rather than abutting against the distal side edge 60a1 of the window area 60a, or only slightly abutting against it. When it is further subjected to the applied radial constraint force, the portion opposite to the distal side edge 60a1 of the window area 60a will, under the action of the constraint force, cause at least a portion of the small curved side 52b to abut against the distal side edge 60a1 of the window area 60a.

[0028] Understandably, when the delivery system 100 includes an outer sheath 40, the outer sheath 40 may provide this radial constraint force. Specifically, as Figure 1 and Figure 1bAs shown, the outer sheath 40 is pushed forward so that the covered stent 60 and the pre-embedded catheter 50 are accommodated between the outer sheath 40 and the sheath core assembly 20. The outer sheath 40 provides radial restraint to the pre-bent section 52 and distal section 53 of the raised pre-embedded catheter 50 (this is the loading state with radial restraint applied). Figure 2 and Figure 2b As shown, when the outer sheath 40 is retracted, the pre-embedded catheter 50 is exposed. Figure 2b Although it still appears to be in a close-fitting state, this is because the outer sheath 40 has just been withdrawn, and the pre-bent section 52 and distal section 53 of the pre-embedded catheter 50 have not yet fully extended. Figure 5 As shown, the outer sheath 40 is further retracted, and the pre-bent section 52 and the distal section 53 gradually stretch out and slightly curl up, presenting a shape as shown. Figure 5 The state in, then as Figure 2c As shown, further rotating the proximal end of the pre-embedded conduit 50 (at which point the applied radial constraint force has been removed) causes the stretched pre-bent section 52 and distal section 53 to rotate accordingly and present the following appearance. Figure 2d The state shown is such that the pre-bent section 52 rotates so that its large bend side 52a is at least partially opposite to the covered stent 60, the small bend side 52b deflects away from the covered stent 60, and the distal section 53 extends away from the covered stent 60. In other embodiments, when the delivery system 100 does not include the outer sheath 40, this radial constraint force can be provided by other constraints. For example, the raised pre-bent section 52 and distal section 53 can be radially bound by constraint wires to achieve a close-fitting loading state. Exemplarily, this scheme without the outer sheath 40 can be applied to intraoperative stent systems in surgical procedures. Of course, the inclusion or exclusion of the outer sheath 40 can be selected as needed.

[0029] Please see Figure 4 and Figure 5 The pre-embedded conduit 50 includes a pipe body 50a, which includes a main section 51, a distal section 53, and a pre-bent section 52 connecting the distal section 53 and the main section 51. The pre-bent section 52 is deflected to one side relative to the axis of the main section 51, and has radially opposite large bending sides 52a and small bending sides 52b. The pre-bent section 52 is an arc-shaped structure formed by pre-bending. The proximal end of the pre-bent section 52 is connected to the distal end of the main section 51, and the distal end of the pre-bent section 52 is connected to the proximal end of the distal section 53. For example, as shown... Figure 4aAs shown, the angle α between the reverse extension line a of the distal segment 53 and the reverse extension line b of the main segment 51 is between 90° and 130°. This range of angle α allows the pre-bending segment 52 to form a smoother, more gradual arc transition, and the profile of the pre-embedded catheter 50 tip is smoother. When the operator rotates the delivery device, the contact and interaction between the pre-embedded catheter 50 tip and the vessel wall is gentler, its trajectory better conforms to the physiological curvature of the aortic arch, and it can maintain conformity to the aortic arch morphology of most patients.

[0030] Please see Figure 4a In one embodiment, the distal segment 53 is a straight segment. The straight segment has stronger directional properties, allowing the extension direction and free end of the distal segment 53 to be more quickly aligned with the branch on the arch after the pre-embedded catheter 50 has been rotated. After the guidewire passes the bend, it can directly select the branch along the straight segment. If the distal segment 53 is set as a curved segment, it will conflict with the pre-bent segment 52, making it difficult to establish a channel for the branch after rotating the pre-embedded catheter.

[0031] In another embodiment, the hardness of the main body segment 51 and the pre-bent segment 52 is greater than the hardness of the distal segment 53. For example, the hardness of the main body segment 51 and the pre-bent segment 52 are equal but both are greater than the hardness of the distal segment 53; or the hardness of the main body segment 51 is greater than the hardness of the pre-bent segment 52, and the hardness of the pre-bent segment 52 is greater than the hardness of the distal segment 53; or the hardness of the main body segment 51 is less than the hardness of the pre-bent segment 52, and the hardness of the main body segment 51 is greater than the hardness of the distal segment 53. Preferably, the hardness of the main body segment 51 and the pre-bent segment 52 are equal but both are greater than the hardness of the distal segment 53. Since the length ratio of the main body segment 51 to the pre-bent segment 52 in the entire pre-embedded conduit is very high, setting the hardness of the main body segment 51 and the pre-bent segment 52 to be greater than the hardness of the distal segment 53 improves the torsional control of the slender pre-embedded conduit 50 on the one hand, and the high hardness facilitates the passage of the guidewire on the other hand. At the same time, the hardness of the pre-bent segment 52 gives it better support, stronger resistance to compression, keeps its cavity unobstructed, and can well maintain its pre-molded shape. In addition, the distal segment 53 has lower hardness to prevent the pre-embedded catheter 50 from scratching the blood vessel wall during movement.

[0032] See Figure 4b One way to achieve a higher hardness for the main body segment 51 and the pre-bent segment 52 than for the distal segment 53 is to have the main body segment 51 and the pre-bent segment 52 as at least a double-layer structure, while the distal segment 53 is a single-layer structure. For example, the main body segment 51 and the pre-bent segment 52 may include at least a braided layer and a covering layer that encapsulates the braided layer. The braided layer can be a metal layer, for example, SUS304, and the covering layer can be a polymer layer, for example, PEBAX. The distal segment 53 may be a single-layer polymer layer, also for example, PEBAX. It should be noted that the layer structure and materials of the main body segment 51, the pre-bent segment 52, and the distal segment 53 are not limited to these. Please continue reading... Figure 4bIn another embodiment, the distal segment 53 includes a first distal segment 531 located at the distal end and a second distal segment 532 connected to the proximal end of the first distal segment. The hardness of the second distal segment 532 is greater than that of the first distal segment 531, making the first distal segment 531 located at the distal end softer than other segments, preventing the pre-embedded catheter 50 from scratching the blood vessel wall during movement. In addition, the hardness of the second distal segment 532 is greater than that of the first distal segment 531 but less than that of the main segment 51 and the pre-bent segment 52, achieving a transitional connection in hardness and avoiding bending.

[0033] Please continue reading Figure 4 In other embodiments, the pre-embedded catheter 50 also includes a catheter connector 50b connected to the proximal end of the tube body 50a, so that the guidewire can pass through the catheter connector 50b into the tube body 50a, and also facilitate the connection of the pre-embedded catheter 50 to other instruments through the catheter connector 50b.

[0034] Please see Figures 5-12 In one embodiment, the self-expanding covered stent 60 includes a main stent 61 and branch stents 62, both of which are tubular. Both the tubular main stent 61 and the tubular branch stents 62 can be radially compressed under external force and can self-expand after the external force is removed. A window 611 is provided on the tube wall of the main stent 61, connecting the inner cavity of the main stent 61 to the outside. The shape of the window 611 can be arbitrary, such as circular, elliptical, spindle-shaped, rectangular, or triangular, but regardless of the shape, it must have a maximum diameter. (Refer to...) Figure 6 As shown, the area within the window opening 611 is the window region 60a. A branch bracket 62 is disposed within the area of ​​the window opening 611 and connected to the main bracket 61. The branch bracket 62 is configured to be movable relative to the main bracket 61. The branch bracket 62 includes a first side portion 62a located at the distal end and a second side portion 62b located at the proximal end. The first side portion 62a and the second side portion 62b together form the branch bracket 62. It should be noted that... Figure 6 The first side 62a and the second side 62b shown in the diagram each account for half of the total area, but this is not a limitation; they can also be different proportions, as long as the first side 62a is located on the distal side (i.e., the left side in the diagram) relative to the second side 62b. The movable branch support 62 has at least a pre-loaded state relative to the main support 61. The "pre-loaded state" means that the shape of the branch support 62 is tilted pre-processed to make it conform as much as possible to the assembly shape of the pre-embedded conduit 50. (Refer to...) Figure 5 and Figure 11 In the pre-loaded state, the branch bracket 62 is inclined relative to the main bracket 61, and the maximum radial height h2 of the second side 62b is greater than the maximum radial height h1 of the first side 62a. In this embodiment, as... Figure 11As shown, the maximum radial height h1 is the length from the axis x'-x' parallel to the central axis xx of the main support 61 to the highest point of the first side 62a, and the maximum radial height h2 is the length to the highest point of the second side 62b. Figure 5 and Figure 11 As shown, after the branch stent 62 of the covered stent 60 is pre-treated by tilting, the pre-embedded conduit 50 can pass through the inner cavity of the main stent 61 in the pre-loaded state and then exit from the branch stent 62, with the distal end 53 positioned outside the main stent 61. At least a portion of the small bend side 52b of the pre-bent section 52 is opposite to the distal edge 60a1 of the tilted outlet of the branch stent 62 (that is, opposite to the outlet edge of the first side 62a). It should be noted that... Figure 5 This diagram illustrates the situation where branch support 62 is in a pre-loaded state, but the conveying system is in a state where no radial constraint force is applied. Figure 11 This diagram illustrates a partial view of the branch support 62 in a pre-loaded state, with radial constraint applied only to the pre-bent section and distal section of the embedded conduit 50 (the applying element is not shown). Figure 11 and 12 As shown, under the loaded state with radial constraint (i.e., when the whole is subjected to radial pressure), the small curved side 52b of the pre-bent section 52 abuts against the distal edge of the inclined outlet of the branch bracket 62, that is, against the outlet edge of the first side 62a. In this embodiment, the pre-bent section 52 is precisely aligned with the branch opening of the branch bracket 62, that is, placed within the window opening range of the branch opening. Under the loaded state with radial constraint, the inclined branch bracket 62 forms a good transition and support for the pre-bent section 52 opposite to it, rather than being pressed under the bracket film or metal frame. Therefore, during the sheathing process, it is subjected to uniform radial pressure, rather than concentrated stress that causes its shape to be straightened, thus perfectly preserving its preset curved shape.

[0035] Continue to refer to Figure 11 In the pre-loaded state, the lowest point of the first side 62a of the inclined branch bracket 62 is located inside the outer surface of the main bracket 61, and there is a transition section 631 between the outlet end of the first side 62a of the inclined branch bracket 62 and the outer surface of the main bracket 61. In the loaded state with radial constraint applied, at least a portion of the small bend side 52b abuts against the outlet end of the first side 62a and the transition section 631. In this embodiment, in the portion where the small bend side 52b abuts, the first side 62a of the branch bracket 62 does not extend beyond the outer surface of the main bracket 61. Therefore, no protrusion is formed at the abutment location, but a smooth transition and support is formed with the transition section 631. This avoids squeezing the pre-bent section 52, causing a significant change in its shape, and well conforms to the pre-plastic shape of the pre-bent section 52.

[0036] Continue to refer to Figures 6-11 In one embodiment, the branch bracket 62 can be connected to the side of the main bracket 61 either internally or externally, that is, the branch bracket 62 can be connected as follows: Figure 7 and Figure 9 As shown, in the pre-loaded state, at least a portion of the branch bracket 62 is built-in (i.e., recessed) and the branch bracket 62 is inclined relative to the main bracket 61 toward the distal end of the main bracket 61 (e.g., ...). Figure 11 (As shown).

[0037] See also Figures 6-11 In one embodiment, the membrane support 60 further includes a connecting membrane sleeve 63. The maximum diameter of the window 611 is larger than the diameter of the branch support 62. One end of the connecting membrane sleeve 63 is connected to the main support 61 at the window 611, and the other end is connected to the branch support 62. When the central axis yy of the branch support 62 is perpendicular to the central axis xx of the main support 61 (e.g., ...), the connection is made more suitable for the branch support 62. Figure 6 The projection profile of the branch bracket 62 on the plane containing the window 611 is located within the ring of the window 611, and an annular region S is formed between the projection profile and the window 611 (e.g., Figure 10 The surface area of ​​the connecting membrane sleeve 63 is larger than the area of ​​the annular region S, allowing the branch support 62 to move radially along the main support 61 to approach or move away from the central axis xx of the main support 61, thus achieving an inward or outward setting. Simultaneously, the branch support 62 can tilt and swing relative to the main support 61. Figure 11 In the pre-loaded state, the branch bracket 62 is close to the central axis xx of the main bracket 61, and the branch bracket 62 is tilted relative to the main bracket 61, so that at least a portion of the connecting membrane sleeve 63 is concave, i.e. Figure 11 The first side portion 62a on the left side is concave, and the outlet end of the first side portion 62a abuts against the concave wall of the connecting membrane sleeve 63. The connecting membrane sleeve 63 between the outlet end of the first side portion 62a and the outer surface of the main support 61 forms a transition section 631. Figure 11 As shown, in this embodiment, the distal sidewall of the inclined branch support 62 provides good support and transition, thereby maintaining the pre-bent section 52's pre-plastic shape. At the same time, the concave wall of the connecting membrane sleeve 63 forms a good transition section 631 between the outer surface of the main support 61 and the outlet of the branch support 62, further adapting to and fitting the shape of the small bend side 52b of the pre-bent section 52. This keeps the pre-bent section of the pre-embedded conduit in a "protected" space, so that its shape will not be destroyed by strong external pressure during subsequent pressing and sheathing processes, and it can maintain its initial pre-bent state for a long time.

[0038] See also Figures 6-11In one embodiment, the branch support 62 includes an inner tube segment 621 and an outer tube segment 622 connected axially. The connection between the inner tube segment 621 and the outer tube segment 622 forms a circumferential connection 623. The first port portion of the connecting membrane sleeve 63 is connected to the branch support 62 at the circumferential connection 623, and the second port portion opposite to the first port portion is connected to the main support 61 at the edge of the window 611, such that the inner tube segment 621 and the outer tube segment 622 are located on the inner and outer sides of the connecting membrane sleeve 63, respectively. The "first port portion" and "second port portion" mentioned in this invention refer to a segment along the extension direction of the connecting membrane sleeve 63. It can be understood that the connecting membrane sleeve 63 may only include the first port portion and the second port portion, in which case the first port portion and the second port portion are connected. Alternatively, the connecting membrane sleeve 63 may include the first port portion, the second port portion, and a connecting segment connecting the first port portion and the second port portion. The extension length of the connecting membrane sleeve 63 can be set as needed. The connecting membrane sleeve 63 is a flexible membrane sleeve, and its shape can change under force. The connecting membrane sleeve 63 can be made of one or more materials such as expanded polytetrafluoroethylene, polyester, and polyurethane.

[0039] Specifically, for the movable branch support 62, the branch support 62 can move at least radially along the main support 61 to approach or move away from the central axis xx of the main support 61, that is, the branch support 62 can be as follows: Figure 6 As shown, move upwards or as Figure 8 The downward movement, as shown, causes the connecting membrane sleeve 63 to protrude or recline relative to the main support 61. For example... Figure 6 and Figure 7 The branch support 62 has at least the outermost protrusion furthest from the central axis of the main support 61, and as follows: Figure 8 and Figure 9 The diagram shows the innermost recessed position closest to the central axis of the main support 61. When... Figure 6 and Figure 7 As shown, when the branch bracket 62 is in its outermost protruding position, the circumferential connection 623 is located above the surface where the window is located, and the connecting membrane sleeve 63 is in the shape of an outwardly protruding boss. When... Figure 8 and Figure 9 As shown, when the branch bracket 62 is in its innermost recessed position, the circumferential connection 623 is located below the surface where the window is located, and the connecting membrane sleeve 63 is in a concave-concave shape. It can be understood that the outermost protruding position and the innermost recessed position are the extreme positions for the vertical movement of the branch bracket 62. During its movement, the branch bracket 62 also includes a transitional position between the outermost protruding position and the innermost recessed position.

[0040] Understandable, see reference Figure 6 and Figure 7When in its outermost protruding position, the inner tube segment 621 is housed within the space enclosed by the boss-shaped connecting membrane sleeve 63. At this time, the free end of the inner tube segment 621 (i.e., the end furthest from the outer tube segment 622) may or may not extend beyond the inner surface of the main support 61. (See also...) Figure 8 and Figure 9 When in the innermost recessed position, the outer tube segment 622 is completely contained within the space enclosed by the concave connecting membrane sleeve 63. At this time, the free end of the outer tube segment 622 (i.e. the end away from the inner tube segment 621) may or may not cross the outer surface of the main support 61.

[0041] For example, the axial length of the branch stent 62 is between 7mm and 10mm. This length range ensures proper anchoring of the branch stent 62, reduces metal irritation, endoleak risk, and the risk of branch abrasion of the vessel. It also provides some margin of error for the release of both the branch stent 620 and the main stent 61, improving the success rate of the procedure and reducing the risk of complications. If the axial length of the branch stent 62 is too short, the stent may easily shift or detach under the impact of blood flow, resulting in disengagement or insufficient overlap at the modular stent connection points. Poorly apposed areas at the edges of the branch stents may be directly exposed to blood flow, easily leading to thrombosis. Furthermore, if the anchoring is insufficient, once separation occurs, it is difficult to anchor the secondary stent, often requiring open surgery. Conversely, if the length is too long, the metal load is too high, increasing the risk of branch vessel occlusion, increasing the difficulty of delivery, increasing mechanical damage during stent implantation, and resulting in a lower margin of error for the release of the main stent.

[0042] In another embodiment, the length of the inner tube segment 621 is greater than the length of the outer tube segment 622. Preferably, the inner tube segment 621 accounts for about 3 / 5 of the length of the branch stent 62, and the outer tube segment 622 accounts for about 2 / 5 of the length of the branch stent 62. This further reduces the risk of the outer branch rubbing against blood vessels and the occurrence of compression, bending, and torsion between branches and branch blood vessels due to inaccurate placement of the main stent. The shorter outer branch makes it more flexible in the circumferential direction and also makes it less likely to rub against blood vessels, improving the error tolerance rate and reducing the difficulty of the operation.

[0043] In other embodiments, the connecting membrane sleeve 63, which is circumferentially connected, is partially multi-layered in the circumferential direction. This partially multi-layered approach ensures the radial support force of the connected cylindrical connecting membrane sleeve 63, preventing it from closing due to weak radial force. On the other hand, the portion without multiple layers can reduce the constraint on the root connection of the branch support, thus ensuring a larger range of motion for the branch support as much as possible.

[0044] like Figure 9 , Figure 10 and Figure 11As shown, in one embodiment, a fixing ring 64 is provided along the edge of the window opening 611 of the main support 61, that is, a fixing ring 64 is fixed at the periphery of the window opening 611. In this embodiment, see [link to documentation]. Figure 11 , fixed ring 64 ( Figure 11 The reddish-brown circle (64) is located below the distal end of the pre-bending section 52. On one hand, the fixing ring 64 supports the pre-bending section 52, preventing its distal end from concave towards the inner side of the main support 61 due to radial pressure, thus effectively ensuring the pre-plastic shape of its bent and abutting portion, which is crucial for subsequent rotational superselection. On the other hand, the fixing ring 64 provides a certain anchoring force, controlling the pull of the branch support 62 as much as possible within the opening range, preventing the branch support 62 from pulling on the film covering the distal anchoring area of ​​the main support 61 during pulsation, thereby ensuring the anchoring of the distal end of the conveying system and preventing distal leakage. Simultaneously, the fixing ring 64 at the distal end also provides a certain distal sealing effect, forming a double seal with the corrugated ring on the distal side of the main support. Understandably, the shape of the fixing ring 64 can be adapted to the shape of the window 611; for example, the fixing ring 64 can also be circular, elliptical, spindle-shaped, rectangular, or triangular. Of course, the shapes of the fixing ring 64 and the window 611 can also be different. Preferably, the retaining ring 64 is elliptical, as the elliptical retaining ring 64 is easier to flatten and gather, and easier to attach to the sheath.

[0045] For example, the retaining ring 64 is formed of tinfoil, but it is not limited to this. The retaining ring 64 is fixed to the periphery of the window opening 611. As one embodiment of fixation, the retaining ring 64 can be fixedly connected to the film at the window opening 611 of the main support 61. The fixation connection method includes heat fusion, sewing, bonding, etc., and is not limited to these.

[0046] See Figure 10 In one embodiment, the branch bracket 62 is eccentrically positioned within the window opening 611 region along the axial direction of the main bracket 61, such that the branch bracket 62 is closer to the proximal side of the window opening, i.e. Figure 10The diagram shows the branch stent 62 positioned closer to the right. The eccentric arrangement of the branch stent 62 serves two purposes. First, when the branch stent 62 is tilted, it facilitates a smooth transition between the sidewall of the branch stent 62 and the connecting membrane sleeve 63, leaving sufficient transition space to ensure the pre-shaped form of the pre-bent section 52. Second, it prevents the main stent 61, which has already been deployed, from being pulled backward, thus avoiding insufficient anchoring at the proximal end of the deployed main stent 61. Third, when the catheter guidewire is inserted into the branch vessel (such as the LSA) through the branch, the edge of the stent branch (distal side) is close to the edge of the vessel (such as the LSA), ensuring accurate axial positioning. Furthermore, the eccentricity of the branch, besides being close to the edge, provides greater flexibility within the fixed ring compared to a centrally located branch, compensating for radial positioning errors (e.g., if the vessel branch is at the 1 o'clock position, but the stent branch is placed at the 12 o'clock position during actual operation, the flexibility of the eccentric branch effectively compensates for this error, ensuring smooth blood flow in the vessel).

[0047] For example, the main support 61 includes a main skeleton and a main film connected to the main skeleton. The main skeleton is tubular in shape and provides support; it can be formed by cutting and / or weaving. The main film can be single-layered or multi-layered. When single-layered, the main film can be placed on the inner or outer wall of the tubular main skeleton. When multi-layered, multiple main films can be placed on the inner or outer walls of the tubular main skeleton simultaneously, or partially on the inner wall and partially on the outer wall. Preferably, the main film is multi-layered, with some layers on the inner wall and some on the outer wall. For example, two layers can be provided, one on the inner wall and one on the outer wall, with the main skeleton positioned between the inner and outer films. When a fixing ring 64 is provided, it can be fixed between the inner and outer films at the periphery of the window opening 611.

[0048] The main frame includes multiple wave-shaped coils, which are arranged sequentially along the axial direction of the main support 61. The multiple wave-shaped coils arranged sequentially along the axial direction are spaced apart or connected. Each wave-shaped coil includes multiple waveform units that are connected end to end in the circumferential direction. Each waveform unit includes a wave crest, a wave trough, and a wave rod connecting the wave crest and the wave trough.

[0049] Reference Figure 10 In one embodiment, the window area 60a / window hole 611 is located on the large bend side of the covered support, and the window area 60a / window hole 611 is located between two wave rings spaced apart axially. The peak of the wave ring on the distal side is located on the distal side of the window area 60a / window hole 611 and is opposite to the window area 60a / window hole 611. The window area 60a / window hole 611 is close to the peak of the wave ring on the distal side.

[0050] Please connect Figure 10 and Figure 11 The main frame contains multiple wavy wave coil structures, including at least a first main wave coil 612 located at the distal end and a second main wave coil 613 located at the proximal end of the first main wave coil 612. Both the first main wave coil 612 and the second main wave coil 613 are wavy. The first main wave coil 612 includes at least a first main wave peak 612a, and the wavy second main wave coil 613 includes at least a second main wave trough 613b. The window 611 is formed on the main body covering film between the first main wave coil 612 and the second main wave coil 613. Preferably, the first main wave peak 612a in the first main wave loop 612 and the second main wave valley 613b in the second main wave loop 613 are axially opposite each other. The opposing first main wave peak 612a and the opposing second main wave valley 613b create a large accommodating space between them. The window area 60a / window hole 611 is disposed on the main film between the opposing first main wave peak 612a and the opposing second main wave valley 613b, with the window area 60a / window hole 611 closer to the first main wave peak 612a in the distal side of the first main wave loop 612. It can be understood that when the fixing ring 64 is provided, the window hole 611 and the fixing ring 64 disposed at the periphery of the window hole 611 are disposed between the opposing first main wave peak 612a and the opposing second main wave valley 613b between the first main wave loop 612 and the second main wave loop 613, and the two ends of the window area 60a / window hole 611 and the fixing ring 64 are respectively opposite to the first main wave peak 612a and the opposing second main wave valley 613b. In this embodiment, the window 611 is close to the first main wave peak 612a in the first main wave loop 612 on the far side, so that the first main wave peak 612a of the first main wave loop 612 can provide better support for the far end section 53 of the pre-embedded conduit 50, and avoid the far end section 53 from collapsing due to the applied radial external force, which would affect the shape of the pre-bent section 52.

[0051] In other embodiments, the wave angle at the first main wave crest 612a is greater than the wave angles at other wave crests in the same loop, such that the distal ends of the window 611 and the fixing ring 64 can extend into the first main wave crest 612a with a larger wave angle. And / or the wave angle at the second main wave trough 613b is greater than the wave angles at other wave troughs in the same loop, such that the proximal ends of the window 611 and the fixing ring 64 can extend into the second main wave trough 613b with a larger wave angle.

[0052] Please see Figure 12 , Figure 12a , Figure 13 and Figure 14Based on any of the above embodiments, the delivery system 100 further includes a restraint assembly 70. The restraint assembly 70 includes a restraint member 71 disposed on the outer periphery of the covered support 60 for radial compression of the covered support 60, and a restraint wire 72 connected to the restraint member 71 for maintaining radial compression of the covered support 60. The restraint wire 72 is located on one side of the pre-embedded conduit 50 in the circumferential direction. Under the loaded state with radial restraint applied, the pre-bent section 52 passes through the outlet 71a of the restraint member 71, and at least a portion of the small bend side 52b abuts against the outlet 71a of the restraint member 71, with the distal section 53 located outside the restraint member 71. Figure 12 and Figure 12a In this configuration, the outer sheath 40 applies radial restraint. The pre-bent section 52 exits from the outlet 71a of the restraining member 71. The restraining member 71 at the outlet 71a provides some support to the small bend side 52b of the pre-bent section 52, which helps maintain the pre-plastic shape of the pre-bent section 52. More importantly, the restraining wire 72 not only maintains the compressed state of the restraining member 71, but also... Figure 14 As shown, the binding wire 72 is located on one side of the pre-embedded catheter 50 in the circumferential direction, providing a circumferential constraint on the pre-embedded catheter 50. When the proximal end of the pre-embedded catheter 50 is rotated, the distal end of the pre-embedded catheter 50 will not wobble due to the circumferential constraint, resulting in better torque transmission. This allows the distal end to quickly respond to the torsion of the proximal end and rotate, facilitating the rapid alignment of the large bend side of the pre-embedded catheter with at least a portion of the covered stent, while the small bend side deflects away from the covered stent, and the distal segment extends towards the side away from the covered stent. Furthermore, this configuration significantly reduces the force required to rotate the pre-embedded catheter 50 proximally. For example, the radial distance from the binding wire 72 on one side of the pre-embedded catheter 50 to the pre-embedded catheter 50 is less than or equal to 0.6 mm, meaning the radial distance between them is less than or equal to 0.6 mm. This distance range ensures constraint while avoiding excessive closeness that would make it difficult to rotate the pre-embedded catheter 50.

[0053] See Figure 12 , Figure 13 and Figure 14 In one embodiment, to achieve controllable rotation direction of the pre-bent section 52, under the loaded state with radial constraint force applied, at least a portion of the restraint member 71 at the outlet 71a is tightly wrapped and abutted against the outer periphery of the pre-embedded conduit 50. That is, after the pre-embedded conduit 50 passes through the outlet 71a, the restraint member 71 at the outlet 71a at least partially covers and abuts against the outer periphery of the pre-embedded conduit 50, thereby forming a circumferential constraint on the pre-bent section 52 of the pre-embedded conduit 50 by the restraint member 71. In this embodiment, the restraint member 71 is tightly abutted against the outer periphery of the pre-embedded conduit 50, and the pre-bent section 52 is in this position, which can form a reliable circumferential constraint on the pre-bent section, making the rotation of the distal end of the pre-embedded conduit 50 more controllable, especially the torsional direction of the pre-bent section 52, making superselection faster and easier.

[0054] Combination Figures 12-15 For example, the restraint member 71 includes a sheet-like membrane 711, which is a membrane layer with a certain degree of extensibility. The membrane 711 can be releasably wrapped around the outside of the membrane-covered support 60. Under the loaded state with radial restraint applied, at least a portion of the membrane 711 at the outlet 71a tightly covers and adheres to the outer periphery of the pre-embedded conduit 50. The membrane 711 can be a PTFE membrane layer. When the pre-bent section 52 passes through the outlet of the restraint member 71, at least a portion of the PTFE membrane layer elastically abuts against the outer periphery of the pre-bent section 52, thereby forming an elastic limit in the circumferential direction. This limit does not compress the plastic shape of the pre-bent section 52. At the same time, this elastic circumferential limit has high reliability and better retention. Even if the position of the pre-embedded conduit 52 is slightly adjusted during assembly, it does not affect the circumferential limit and is always in a state of elastic abutment. This allows the distal end of the pre-embedded conduit to rotate in a controllable direction in a timely manner based on the torsion of the proximal end. This is crucial for the rapid superselection of the pre-embedded conduit.

[0055] Reference Figure 14 and Figure 15 For example, the membrane 711 includes two circumferentially opposite edges 7111, each edge 7111 having an axially spaced limiting hole 7112. A binding wire 72 passes through the limiting hole 7112, causing the two edges 7111 to align. The binding wire 72 passing through the limiting hole 7112 forms a plurality of axially spaced constraint positions 71b with the membrane 711. Each constraint position 71b includes at least an axially adjacent first constraint position 71b1 and a second constraint position 71b2. The pre-embedded conduit 50 passes through the two edges between the first constraint position 71b1 and the second constraint position 71b2. At this time, the exit port 71a is formed between the two edges between the first constraint position 71b1 and the second constraint position 71b2. At least a portion of the two edges between the first constraint position 71b1 and the second constraint position 71b2 covers and adheres tightly to the outer periphery of the pre-embedded conduit 50, thereby forming a circumferential constraint on the pre-embedded conduit 50. In this embodiment, as... Figure 14 As shown, at least a portion of the edge 7111 on the side away from the binding wire 72 between the first constraint position 71b1 and the second constraint position 71b2 covers and adheres tightly to the outer periphery of the pre-embedded conduit 50. This ensures that the distance between the binding wire 72 and the pre-embedded conduit 50 is appropriate, while allowing one edge of the film 711 to cover and abut against the outer periphery of the pre-bent section 52, forming an elastic constraint limit. This not only provides good constraint to the main body section 51 of the pre-embedded conduit 50, but also provides good elastic constraint limit to the pre-bent section 52, resulting in better torque transmission and better controllability of the rotation of the pre-bent section.

[0056] Please continue to refer to Figure 14In one embodiment, the axial distance M1 between the first constraint position 71b1 and the second constraint position 71b2 is 0.1mm to 0.4mm larger than the diameter N2 of the pre-embedded conduit 50. Within this range, it can be ensured as much as possible that at least part of the two sides of the through-hole 71a elastically covers and closely adheres to the outer periphery of the pre-embedded conduit 50, forming an elastic constraint and limit on the circumferential direction of the pre-bent section 52 of the pre-embedded conduit 50, ensuring the constraint effect, and realizing controllable and rapid response of the bending angle of the pre-bent section 52. If the difference between the two dimensions is too large, the axial distance M1 will be large, resulting in inadequate constraint, which will be too loose and unable to form a good circumferential limit; while if the difference is too small, the elastic contact will be too tight, and the circumferential constraint on the pre-embedded conduit 50 will be too tight, causing the pre-embedded conduit 50 to require a large force to rotate. This requires a large force to be applied at the proximal end, and due to the long-distance torsion, the rotation direction of the pre-bent section 52 is difficult to control. Therefore, in this embodiment, the axial spacing M1 is 0.1mm to 0.4mm larger than the diameter N2 of the pre-embedded conduit 50, which ensures both the effectiveness of the circumferential constraint and the rapid and controllable rotation.

[0057] Please continue to refer to Figure 14 In another embodiment, the radial distance M2 from the binding wire 72 between the first constraint position 71b1 and the second constraint position 71b2 to the pre-embedded conduit 50 is less than or equal to 0.6 mm. This distance ensures constraint while avoiding the pre-embedded conduit 50 from being difficult to rotate due to the distance being too close.

[0058] In other embodiments, the distal end of the window area 60a is located between the first constraint position 71b1 and the second constraint position 71b2 or on the proximal side of the first constraint position 71b1 and the second constraint position 71b2, so that the pre-bent segment 52 can naturally and compliantly pass through the outlet 71a formed between the two side edges between the first constraint position 71b1 and the second constraint position 71b2 after extending from the window area 60a.

[0059] Please see Figure 1 , Figure 2 , Figure 2c as well as Figure 16 , Figure 16a , Figure 16bIn order to solve at least some of the problems in the technical problem (2) in the background section, the present invention provides an exemplary conveying system 100, the conveying system 100 including at least a conveying handle 10, a loading clutch component 90 and a pre-embedded conduit 50, wherein the conveying handle 10 includes a branch joint 13, the branch joint 13 is provided with a first branch cavity 131, at least a portion of the loading clutch component 90 can be inserted into the first branch cavity 131, the pre-embedded conduit 50 can be inserted into and pass through the loading clutch component 90 to enter the conveying handle 10, and the pre-embedded conduit 50 passing through the loading clutch component 90 can move back and forth relative to the branch joint 13 along the loading clutch component 90 under the action of external force. In this exemplary solution, compared with the prior art, a special constraint structure loading clutch component 90 is set that can be inserted into the delivery handle 10. The pre-embedded catheter 50 passes through the loading clutch component 90, and the loading clutch component 90 forms support and constraint, so that there is no offset or radial sway when the pre-embedded catheter 50 moves back and forth or rotates for adjustment, thus ensuring stability. At the same time, it reduces the frictional resistance between the catheter and the delivery handle, reduces the wear on the surface coating of the pre-embedded catheter, and makes the movement of the pre-embedded catheter smoother and the operation smoother, reducing surgical risks and saving surgical time.

[0060] In other embodiments, the delivery system 100 may optionally include structures such as a film-coated support 60, a sheath-core assembly 20, and a restraint assembly 70. These structures are as described above and will not be repeated here. It should be understood that the effects and technical problems solved by the aforementioned film-coated support 60, sheath-core assembly 20, and restraint assembly 70 are also inherent in this embodiment.

[0061] In one embodiment, the delivery handle 10 further includes an elastic seal 14 disposed within the branch joint 13. The elastic seal 14 is located at the end portion of the first branch cavity 131 and is fixed relative to the branch joint 13. The elastic seal 14 may be located at the proximal end of the first branch cavity 121, or it may be located as follows: Figure 16 As shown, the elastic seal 14 can be located at the distal end of the first branch cavity 121. The elastic seal 14 can be fixed relative to the branch joint 13 in ways including, but not limited to, providing a groove within the branch joint 13 and engaging the elastic seal 14 within the groove, thereby achieving relative fixation between the elastic seal 14 and the branch joint 13. For the pre-embedded conduit 50 or the loading clutch component 90 to pass through the elastic seal 14, refer to... Figure 16a and Figure 16bThe elastic seal 14 has a first through hole 141. The loading clutch member 90 is configured to selectively insert at least partially into the first through hole 141 and elastically abut against the elastic seal 14. In this embodiment, "selectively" means that the loading clutch member 90 can be selectively inserted into the first through hole 141. For example, the loading clutch member 90 may be inserted into or not inserted into the first through hole 141. Alternatively, the distal end of the loading clutch member 90 may pass through the first through hole 141, or a portion of the distal end may be inserted into the first through hole 141 without the distal end exiting, i.e., partial insertion. It is understood that when partial insertion or non-insertion occurs, the pre-embedded conduit 50 passing through the loading clutch member 90 will either partially insert into the first through hole 141 or exit entirely from the first through hole 141. The solution in this embodiment not only achieves the sealing setting in the branch joint 13 of the conveying handle 10, but also the loading of the clutch component 90 can provide special constraint on the pre-embedded conduit 50, making the movement of the pre-embedded conduit 50 more stable and smoother.

[0062] Based on the above-mentioned arrangement of the elastic seal 14 and the loading clutch member 90, and the selective insertion method of the loading clutch member 90, there are at least the following situations, and the selection of the following situations can be set as needed.

[0063] As one implementation method, refer to Figure 16a As shown, the conveying system 100 includes a first state. In the first state, the distal end of the loading clutch member 90 is configured to pass through the first through hole 141 and elastically abut against the elastic seal 14, so that the loading clutch member 90 and the elastic seal 14 are engaged. At this time, the engagement is such that the outer wall of the loading clutch member 90 elastically abuts against the elastic seal 14. Meanwhile, the pre-embedded conduit 50 is configured to pass through the loading clutch member 90 engaged with the elastic seal 14, so that the pre-embedded conduit 50 and the elastic seal 14 are separated. In this manner, the seal at the proximal end of the handle is achieved by the loading clutch member 90 passing through the first through hole 141 and elastically abutting against the elastic seal 14.

[0064] As another implementation method, refer to Figure 16b As shown, the conveying system 100 includes a second state. In the second state, the loading clutch member 90 is configured to exit the first through hole 141 and separate from the elastic seal 14, so that the loading clutch member 90 and the elastic seal 14 are separated. At this time, the outer wall of the loading clutch member 90 is not in elastic contact with the elastic seal 14. The pre-embedded conduit 50 is configured to pass through the loading clutch member 90 separated from the elastic seal 14 and simultaneously pass through the first through hole 141 to elastically contact the elastic seal 14, so that the pre-embedded conduit 50 and the elastic seal 14 are engaged. In this mode, the seal at the proximal end of the handle is achieved by the pre-embedded conduit 50 passing through the first through hole 141 and elastically contacting the elastic seal 14.

[0065] As another implementation method, combined with Figure 16a and Figure 16b As shown, the conveying system 100 includes both a first state and a second state, and the first state and the second state can be switched at will. In the first state, the loading clutch component 90 is configured such that its distal end passes through the first through hole 141 and elastically abuts against the elastic seal 14, so that the loading clutch component 90 and the elastic seal 14 are engaged. At this time, the engagement is such that the outer wall of the loading clutch component 90 elastically abuts against the elastic seal 14, while the pre-embedded conduit 50 is configured to pass through the loading clutch component 90 engaged with the elastic seal 14, so that the pre-embedded conduit 50 and the elastic seal 14 are separated. In the second state, the loading clutch component 90 is configured to exit the first through hole 141 and separate from the elastic seal 14, so that the loading clutch component 90 and the elastic seal 14 are separated. At this time, the outer wall of the loading clutch component 90 is not elastically abutting against the elastic seal 14, and the pre-embedded conduit 50 is configured to pass through the loading clutch component 90 separated from the elastic seal 14, and at the same time pass through the first through hole 141 and elastically abut against the elastic seal 14, so that the pre-embedded conduit 50 and the elastic seal 14 are engaged.

[0066] In this embodiment, when both the first and second states are included, the loading clutch component 90 can move relative to the branch joint 13 along the extension direction of the first branch cavity 131. The first and second states can be switched during the movement of the loading clutch component 90. In the first state, the pre-embedded conduit 50 can move back and forth relative to the branch joint 13 under the action of a first external force. In the second state, the pre-embedded conduit 50 can move back and forth relative to the branch joint 13 under the action of a second external force, where the second external force is greater than the first external force. In this mode, the loading clutch component 90 acts as a clutch component, and the operator can move the loading clutch component 90 as needed, thereby causing the loading clutch component 90 to elastically abut against the elastic seal 14 in an engaged state, or to disengage and not elastically abut against the elastic seal 14 in a separated state. Figure 16a When the pre-embedded conduit 50 is moved toward the distal end, the loading clutch component 90 can elastically abut against the elastic seal 14 (this is the first state). At this time, the pre-embedded conduit 50 passes through the loading clutch component 90 without contacting the elastic seal 14. Therefore, the pre-embedded conduit 50 can achieve smooth and stable movement and rotation under relatively small external forces. When the pre-embedded conduit 50 moves to the designated position, it can... Figure 16bAs shown, when the loading clutch component 90 is pulled back, it moves proximally, causing it to exit the first through hole 141 and disengage from the elastic seal 14 (this is a transition from the first state to the second state). At this point, the pre-embedded conduit 50 passes through the first through hole 141 and elastically abuts against the elastic seal 14. This elastic abutment generates significant friction, requiring considerable external force to overcome it for the pre-embedded conduit 50 to move or rotate. This allows for the fixation of the axial position of the pre-embedded conduit 50, preventing it from moving or wobbling arbitrarily. This helps maintain the orientation and extension direction of the pre-bent section 52 and distal section 53 at the distal end of the pre-embedded conduit 50, ensuring positional stability during over-selection and facilitating subsequent operations. When it is necessary to readjust the forward / backward or rotational position of the pre-embedded conduit 50, it can be done again as described above. Figure 16a As shown, pushing the loading clutch component 90 forward causes the distal end of the unloading clutch component 90 to re-pass through the first through hole 141 and elastically abut against the elastic seal 14 again, i.e., re-engagement (i.e., switching from the second state to the first state). At this time, the pre-embedded conduit 50 can be adjusted again under a smaller external force. Once adjusted, it can continue as follows. Figure 16b As shown, the loading clutch component 90 is pulled back, thereby allowing the pre-embedded conduit 50 to elastically abut against the elastic seal 14 (i.e., switching from the first state to the second state), thus stabilizing the position of the pre-embedded conduit 50. This embodiment at least solves the problem of excessive friction when the branch conduit overselects LSA in the technical problem (2) of the background art.

[0067] See Figure 4 as well as Figure 16a , Figure 16bIn one embodiment, a conduit limiting member 50c is provided on the outer surface of the pre-embedded conduit 50. Specifically, the conduit limiting member 50c is disposed on the outer surface of the tube body 50a of the pre-embedded conduit 50. When the pre-embedded conduit 50 passes through the loading clutch member 90, the conduit limiting member 50c is disposed on the distal end side of the loading clutch member 90, and the maximum diameter of the conduit limiting member 50c is greater than the distal inner diameter of the loading clutch member 90; or the maximum diameter of the conduit limiting member 50c is greater than the diameter of the first through hole 141; or when a baffle 15 is present (see 17d), the maximum diameter of the conduit limiting member 50c is greater than the diameter of the second through hole 151 on the baffle 15. When the pre-embedded conduit 50 moves and causes the conduit limiting member 50c to abut against the loading clutch member 90, the elastic seal member 14, or the baffle 15, the distal end of the pre-embedded conduit 50 does not detach from the window area 60a. This prevents the pre-embedded conduit 50 from moving excessively towards the proximal end, causing the end of the pre-embedded conduit 50 to detach from the window area 60a, and prevents the loading state from failing, thus rendering the delivery system unusable. This embodiment at least solves the problem in the background art section (2) where, if the operation is improper when releasing the support or adjusting the position of the branch conduit, the branch conduit may accidentally detach from the branch port of the support, i.e., the problem of the lack of a branch conduit anti-detachment mechanism.

[0068] See Figure 4 For example, the conduit limiting member 50c is disposed on the outer periphery of the pre-embedded conduit 50. The conduit limiting member 50c includes a proximal section 50c2 and a distal section 50c1 connected axially. The outer diameter of the proximal section 50c2 is set to be equal, and the outer diameter of the distal section 50c1 gradually decreases from the point where it is connected to the proximal section 50c2 to the distal end. This forms a larger diameter end face on the proximal side, which not only prevents the end of the pre-embedded conduit 50 from detaching from the window area 60a when it moves towards the proximal end, but also prevents the proximal side of the pre-embedded conduit 50 from entering the distal side of the loading clutch member 90, the first through hole, or the second through hole and getting stuck when the proximal side abuts against the loading clutch member 90, the elastic seal member 14, or the baffle 15 during the movement towards the proximal end.

[0069] Reference Figure 17dIn other embodiments, a baffle 15 is also included. The hardness of the baffle 15 is greater than that of the elastic seal 14. For example, the baffle 15 is a metal baffle. The baffle 15 is placed inside the branch joint 13 and located on the proximal side of the conduit limiting member 50c. The baffle 15 has a second through hole 151 through which the pre-embedded conduit 50 can pass. The diameter of the second through hole 151 is smaller than the maximum diameter of the conduit limiting member 50c, so as to restrict the pre-embedded conduit 50 from moving towards the proximal end and causing the distal end of the pre-embedded conduit 50 to detach from the window area 60a, thereby preventing the loading state of the delivery system from failing. In this embodiment, based on the setting of the baffle 15, on the one hand, the problem of jamming at the front is solved, and on the other hand, the first through hole 141 on the elastic seal 14 can be slightly enlarged to reduce the frictional force during elastic contact.

[0070] Continue reading Figure 16a , Figure 16b as well as Figure 17b , Figure 17c , Figure 17d Preferably, the elastic seal 14 is located on the distal side of the first branch cavity 131 and fixed relative to the branch joint 13. The distal end of the elastic seal 14 is recessed inward to form a recessed cavity 142, such that the elastic seal 14 includes an elastic bottom wall 143 located on the proximal side and an elastic side wall 144 surrounding the elastic bottom wall 143. The first through hole 141 is provided on the elastic bottom wall 143. This structure of the elastic seal 14 allows the recessed cavity 142 to provide a certain amount of movement space for the conduit 50 when the pre-embedded conduit 50 includes the conduit limiting member 50c, without causing the delivery handle to extend. At the same time, only the elastic bottom wall 143 provides elastic friction, reducing the elastic friction force.

[0071] Please continue reading. Figure 4 In one embodiment, the pre-embedded conduit 50 includes a tube body 50a, which includes a proximal segment and a distal segment connected axially. The hardness of the proximal segment is greater than that of the distal segment. As one way to achieve the greater hardness of the proximal segment than the distal segment, a reinforcing tube 50d is sleeved on the proximal segment of the tube body 50a. This increases the strength of the proximal end of the pre-embedded conduit 50a, resulting in better proximal pushability and smoothness, while ensuring the flexibility of the distal segment of the pre-embedded conduit 50a.

[0072] See also Figure 16a , Figure 16b ,as well as Figure 17 , Figure 17a , Figure 18 and Figure 18aFor example, the loading clutch component 90 includes a loader clutch tube 91 and a loader connector 92 connected to the proximal end of the loader clutch tube 91. The loader clutch tube 91 can be inserted into the first branch cavity 131, and the loader connector 92 is connected to the branch connector 13. The proximal end of the first branch cavity 131 is provided with a fixed connection portion 132, and the loader connector 92 is provided with a connection portion 921 adapted to the fixed connection portion 132. When the loader clutch tube 91 is inserted into the first branch cavity 131, the fixed connection portion 132 and the connection portion 921 are detachably connected. The detachable connection method includes, but is not limited to, a threaded connection.

[0073] Continue reading Figure 18a The outer diameter of the distal portion of the clutch assembly 90 gradually decreases from near to far, causing the distal end of the clutch assembly 90 to cover the outer periphery of the pre-embedded conduit 50. This constricted covering method serves two purposes: firstly, it provides good constraint and radial limiting support for the pre-embedded conduit 50 from the clutch assembly 90, preventing the pre-embedded conduit 50 from shaking; secondly, it prevents the conduit limiting member 50c from extending into the distal end of the clutch assembly 90 and causing jamming when the conduit limiting member 50c is installed on the pre-embedded conduit 50. Furthermore, a metal ring 93 is fitted onto the distal end of the clutch assembly 90, improving the smoothness of the pre-embedded conduit during the fitting of the two components, while also preventing jamming caused by materials being the same.

[0074] Please continue reading. Figure 19 and Figure 20 In one embodiment, the conveying handle 10 further includes a pulling member 16, one end of which is connected to a branch joint 13, and the other end of which is detachably connected to a loading clutch member 90 extending from the branch joint 13. When the loading clutch member 90 is in a first state, i.e., when the loading clutch member 90 is inserted into the first through hole 141 of the elastic seal 14, as... Figure 19 As shown, the pulling member 16 connects the branch joint 13 and the loading clutch component 90. When the loading clutch component 90 switches to the second state, that is, when the loading clutch component 90 moves backward and exits the first through hole 141 of the elastic seal 14, although the position of the loading clutch component 90 moves, the pulling member 16 still connects the branch joint 13 and the loading clutch component 90. Moreover, the pulling member 16 has a constraint on the maximum backward movement distance of the loading clutch component 90 to prevent the loading clutch component 90 from moving too far backward. When it is necessary to switch to the first state, the switching can be carried out quickly.

[0075] Please see Figure 1 , Figure 1a , Figure 1b , Figure 2 , Figure 2a , Figure 2b as well as Figure 3 , Figure 3a , Figure 3bIn order to at least solve the problem mentioned in the background section regarding the withdrawal of the conveyor under compression, the guide wire 13' passing through the branch conduit 12' and entering the bow branch ( Figure 1-1 The blue lines in the diagram indicate that the branch catheter 12' under pressure will be removed (i.e., the technical problem described in point (3) of the background section). This embodiment provides a delivery system 100, which includes at least a delivery handle 10, a sheath core assembly 20, an outer sheath 40, and a limiting assembly 80. The delivery handle 10 includes a handle 10a, which includes a front handle 11 and a rear handle 12 that are axially opposite each other. The rear handle 12 can move back and forth relative to the front handle 11 to approach or move away from the front handle 11. The outer sheath 40 is sleeved on the sheath core assembly 20 and the distal end of the sheath core assembly 20 extends from the distal end of the outer sheath 40. The proximal ends of the outer sheath 40 and the sheath core assembly 20 are both connected to the delivery handle 10, and at least a portion of the sheath core assembly 20 is fixed relative to the front handle 11. The outer sheath 40 is connected to the rear handle 12 and the outer sheath 40 can move axially with the movement of the rear handle 12. Figure 1a As shown, the rear handlebar 12 and the front handlebar 11 have a minimum distance W0 in the initial state, and a movement distance W greater than the minimum distance W0 formed after the rear handlebar 12 is moved (e.g., ...). Figure 2a and Figure 3a As shown in the figure, the moving distance W includes a preset limiting distance Wmax. A limiting component 80 is disposed on the front handlebar 11 and / or the rear handlebar 12. The limiting component 80 is configured such that when the moving distance W of the rear handlebar 12 is greater than or equal to the limiting distance Wmax, the limiting component 80 at least partially extends into the gap between the rear handlebar 12 and the front handlebar 11 to form an axial limit. In this embodiment, the limiting component 80 may be disposed on the front handlebar 11 (e.g., ...). Figure 2a It can be installed on the front handlebar 11 or the rear handlebar 12 (as shown), or on both the front handlebar 11 and the rear handlebar 12, depending on the specific requirements. Figure 1a The initial minimum distance W0 approaches zero or equals zero infinitely. When the opposing surfaces of the front handle 11 and the rear handle 12 abut, the initial minimum distance W0 can be considered equal to zero. However, due to manufacturing errors or other reasons, the actual minimum distance W0 between the two may not be equal to zero. In this embodiment, a limiting component 80 is provided on the conveying handle of the conveying system. When the rear handle 12 of the conveying handle is opened, the limiting component 80 will be placed between the front handle 11 and the rear handle 12. After the film-coating bracket is released, the front handle and the rear handle of the conveying handle merge. Because the limiting component 80 is located between them, the two will not completely merge. Therefore, as... Figure 3b As shown, the tip of the sheath core assembly 20 and the outer sheath tube 40 of the delivery system 100 will not clamp the guide wire l, and will not affect the guide wire l when withdrawing from the delivery system, thus not causing the guide wire channel to fail.

[0076] In one embodiment, the delivery system 100 further includes a pre-embedded conduit 50 passing between the sheath core assembly 20 and the outer sheath tube 40; combined with Figure 1a and Figure 1b When the front handle 11 and the rear handle 12 are in their initial minimum distance W0, the distal end of the outer sheath 40 abuts against the proximal end of the tip of the sheath core assembly 20, or the distal end of the outer sheath 40 covers the proximal portion of the tip of the sheath core assembly 20. The maximum radial distance N1 from the inner wall of the distal end of the outer sheath 40 to the outer wall of the sheath core assembly 20 is less than the diameter N2 of the pre-embedded conduit 50. In this state, the distal end of the pre-embedded conduit 50 is accommodated between the sheath core assembly 20 and the outer sheath 40 and will not protrude from between them. Figure 2a , Figure 3a and Figure 3b When the moving distance W after the rear handle 12 moves is greater than or equal to the limiting distance Wmax, the maximum radial distance N3 from the distal inner wall of the outer sheath 40 to the outer wall of the sheath core assembly 20 is not less than the diameter N2 of the pre-embedded conduit 50. When the moving distance W after the rear handle 12 moves is greater than or equal to the limiting distance Wmax, the distance between the outer sheath 40 and the sheath core assembly 20 increases. Figure 1b The spacing N1 in the middle increases to Figure 3b The spacing N3 is such that, in this state, the pre-embedded conduit 50 can pass through the space between the sheath core assembly 20 and the outer sheath tube 40 without clamping the guide wire L, and the guide wire is unaffected when the delivery device is withdrawn. It should be noted that, ideally, the spacing N1 approaches zero infinitely. When the inner wall of the outer sheath tube 40 abuts against the outer wall of the sheath core assembly 20, the spacing N1 can be considered zero. Furthermore, since the delivery system 100 may have bends, when bending occurs, the distance between the inner wall of the outer sheath tube 40 and the outer wall of the sheath core assembly 20 may be large on one side, while the radial distance on the other side may be small or even abutting. In this case, there will be a maximum radial spacing N1 and a maximum radial spacing N3.

[0077] Combination Figure 1 and Figure 1a The limiting component 80 is configured to be in a non-limiting state when the moving distance W < the limiting distance Wmax, and is located on the outer periphery of the handle 10a. Figure 2 and Figure 2a as well as Figure 3 and Figure 3a When the moving distance W ≥ the limiting distance Wmax, at least part of the extension into the gap between the rear handle 12 and the front handle 11 is in a limiting state.

[0078] In one embodiment, when the movement distance W ≥ the limiting distance Wmax, the limiting component 80 is configured to at least partially extend into the gap between the rear handle 12 and the front handle 11 without external force, thus placing the limiting component 80 in a limited state. In this embodiment, no additional external force is required from the operator. As the movement distance W changes, the limiting component 80 automatically extends at least partially into the gap between the rear handle 12 and the front handle 11, and the limited state is naturally achieved. This eliminates the need for the operator to consider the movement distance, improving operational safety. See Figure 1a In one implementation, the limiting component 80 is elastic. The limiting component 80 includes a fixed end 80a and a free end 80b axially opposite each other (the fixed end 80a is on the left and the free end 80b is on the right in the figure). The fixed end 80a is connected to the front handle 11 or the rear handle 12. In this embodiment, the fixed end 80a of the limiting component 80 is connected to the front handle 11, and the free end 80b elastically abuts against the outer periphery of the rear handle 12. Under elastic action, the free end 80b tends to move towards the central axis of the conveying handle 10. That is, in the non-limiting state, the free end 80b of the limiting component 80 radially expands outward relative to the central axis of the conveying handle 10 and elastically abuts against the outer wall of the conveying handle 10; Figure 2a In the limited position, as the rear handle 12 moves backward, the free end 80b of the limiting component 80 will lose the support of the rear handle 12. Under its own elasticity, the free end 80b will move toward the central axis of the conveying handle 10 and at least partially extend into the gap between the rear handle 12 and the front handle 11.

[0079] Combination Figure 1a , Figure 2a , Figure 3a as well as Figure 21 The limiting component 80 includes a resilient spring 81 and a limiting seat 82. The fixed end of the spring 81 is connected to the front handle 11 or the rear handle 12, and the free end of the spring 81 is connected to the limiting seat 82. Figure 1a In the non-limited state, the free end of the limiting component 80 expands radially outward relative to the central axis of the conveying handle 10, and the limiting seat 82 elastically abuts against the outer wall of the handle 10a; as Figure 2a and Figure 3a In the limited position, the limiting seat 82 moves toward the central axis of the conveying handle 10 under the elastic action of the spring 81, and at least a part of the limiting seat 82 extends into the gap between the rear handle 12 and the front handle 11.

[0080] Reference Figure 21The spring piece 81 is fixed by a bending structure, which includes a first fixing part 811 and a second fixing part 812 that are radially spaced apart from each other, and a fixing connection part 813 that connects the first fixing part 811 and the second fixing part 812. The first fixing part 811 extends into the housing of the front handle 11 or the rear handle 12, and the second fixing part 812 is located on the outer periphery of the front handle 11 or the rear handle 12. Continue to refer to Figure 21 In one embodiment, the limiting seat 82 includes a connecting portion 821 and a limiting portion 822. One end of the connecting portion 821 is fixed to the free end of the spring piece 81, and the other end of the connecting portion 821 is a free end. The limiting portion 822 is connected to the side of the connecting portion 821 near the central axis of the conveying handle 10. Figure 2a In the limited position, the limiting part 822 extends into the gap between the rear handle 12 and the front handle 11.

[0081] In one embodiment, such as Figure 2a As shown, when the limiting seat 82 includes the connecting part 821 and the limiting part 822, the connecting part 821 is flat, and the free end of the flat connecting part 821 is bent toward the side away from the central axis of the conveying handle 10, so that the far end of the handle 12 can enter the limiting seat 82 after the handle 12 moves forward in the limiting state, thereby achieving further locking.

[0082] like Figure 2a , Figure 3a , Figure 21 As shown, in one embodiment, when the limiting seat 82 includes a connecting portion 821 and a limiting portion 822, a limiting boss 823 protrudes from the side of the limiting portion 822 facing the handle 10a axially opposite to it, and a slot (not shown) adapted to the limiting boss 823 is provided on the end face of the handle 10a opposite to it. Figure 3a In the limited position, the limiting boss 823 can extend into the slot to prevent the handle 10a from rotating, thereby locking the position at this time.

[0083] Reference Figure 22 In one embodiment, the conveying system 100 further includes a push rod 30, which is sleeved between the sheath core assembly 20 and the outer sheath tube 40. The push rod 30 includes a rod body 31 and a damage prevention head 32 located at the distal end of the rod body 31. The distal end face of the damage prevention head 32 is curved. The rod body 31 and the damage prevention head 32 are provided with a plurality of through holes penetrating both of them.

[0084] Reference Figure 23In one embodiment, the sheath core assembly 20 includes an inner sheath core 21 and an outer sheath core (not shown) sleeved outside the inner sheath core 21. The inner sheath core 21 includes an inner sheath core rod 211 and a tip head 212 connected to the distal end of the inner sheath core rod 211. The tip head 212 is provided with a constraint hole 213 that axially penetrates the tip head 212. The constraint hole 213 is used for the distal end of the binding wire 72 of the binding film support 60 to pass through.

[0085] Reference Figure 2c , Figure 24 , Figure 24a as well as Figure 24b In other embodiments, a pull cord buckle 17 is detachably disposed near the end of the delivery handle 10. The pull cord buckle 17 includes a winding seat 171 with an axial through hole 1711. The proximal end of the binding wire 72 for constraining the film-coated bracket 60 can pass through the axial through hole, wrap around the circumference of the winding seat 171 at least half a turn, and then pass through the axial through hole 1711 again to be fixed relative to the pull cord buckle 17.

[0086] The operation of the exemplary conveying system 100 of the present invention will be briefly described below: like Figure 25a As shown, the master wire 200 is introduced into the ascending aorta to establish an access channel in the aortic arch. Then, the delivery system 100 is introduced along the master wire 200. The delivery system 100 is slowly introduced into the tissue along the master wire 200 until the distal end of the delivery system 100 is introduced into the descending aorta. Then, the rear handle 12 of the delivery handle 10 is withdrawn or rotated to withdraw the connected outer sheath 40 to the distal end of the covered stent 60. The covered stent 60, which is bound by the restraint component 70, is exposed outside the outer sheath 40. Since the covered stent 100 is wrapped by the restraint component 70 and radially bound, the delivery system 100 can still continue to be adjusted along the master wire 200 after the outer sheath 40 is withdrawn, so as to accurately position the covered stent 100. At this time, the pre-embedded catheter 50 is also exposed after the outer sheath 40 is withdrawn.

[0087] like Figure 25b As shown, after the outer sheath 40 is retracted to expose the pre-embedded catheter 50, the delivery system 100 is pushed forward further so that the exposed pre-embedded catheter 40 is aligned with the branch opening of one of the supraclavicular branches 300 (e.g., the left subclavian artery).

[0088] like Figure 25c As shown, further rotating the proximal end of the pre-embedded conduit 50 extending beyond the delivery handle (at this point, the applied radial constraint force has been removed), the pre-bent section 52 and the distal section 53 exhibit the following characteristics as the proximal end of the pre-embedded conduit 50 rotates: Figure 25cIn the indicated configuration, the large bend side 52a of the pre-bent section 52 is at least partially opposite to the covered stent 60, while the small bend side 52b is deflected away from the covered stent 60, and the distal section 53 extends away from the covered stent 60. At this point, the extension direction and free end of the distal section 53 are directly opposite the upper branch 300. The branch guidewire 201 is then introduced from the tail end of the pre-embedded catheter 50.

[0089] like Figure 25d As shown, the pre-embedded catheter 50 and the branch guidewire 201 are further pushed and adjusted. After the distal end of the pre-embedded catheter 50 is aligned with the opening of the supraclavicular branch vessel, the branch guidewire 201 is selected and inserted into the left subclavian artery. The pre-embedded catheter is then advanced until the branch guidewire is finally in the ideal position.

[0090] It should be noted that the above embodiments can be combined arbitrarily to solve at least one of the technical problems.

[0091] In the description of this specification, the references to terms such as "preferred embodiment," "another embodiment," "other embodiment," or "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0092] Although embodiments of this application have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting this application. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of this application.

Claims

1. A support system, characterized in that, The device includes a delivery handle, a sheath core assembly, an outer sheath, a self-expanding covered support, a loading clutch component, and a pre-embedded conduit. The outer sheath is sleeved over the sheath core assembly, with the distal end of the sheath core assembly extending from the distal end of the outer sheath. The proximal ends of both the sheath core assembly and the outer sheath are connected to the delivery handle. The covered support can be compressed and loaded between the distal sheath core assembly and the outer sheath. The delivery handle includes a branch joint with a first branch cavity. At least a portion of the loading clutch component can be inserted into the first branch cavity. The pre-embedded conduit can be inserted and pass through the loading clutch component, entering the delivery handle and extending into the distal covered support. The pre-embedded conduit passing through the loading clutch component can move back and forth relative to the branch joint under external force along the loading clutch component.

2. The support system according to claim 1, characterized in that, It also includes an elastic seal disposed within the branch joint, the elastic seal being located at the end side of the first branch cavity and fixed relative to the branch joint, the elastic seal having a first through hole, and the loading clutch member being configured to selectively insert at least partially into the first through hole and elastically abut against the elastic seal.

3. The support system according to claim 2, characterized in that, The support system includes a first state in which the loading clutch member is configured to pass through the first through hole and elastically abut against the elastic seal, such that the loading clutch member and the elastic seal are engaged; and the pre-embedded conduit is configured to pass through the loading clutch member engaged with the elastic seal, such that the pre-embedded conduit and the elastic seal are disengaged; and / or, The support system includes a second state in which the loading clutch component is configured to exit the first through hole and separate from the elastic seal, such that the loading clutch component and the elastic seal are separated. The pre-embedded conduit is configured to pass through the loading clutch component separated from the elastic seal and simultaneously pass through the first through hole and elastically abut against the elastic seal, such that the pre-embedded conduit and the elastic seal are engaged.

4. The support system according to claim 3, characterized in that, The support system includes a first state and a second state. The loading clutch component can move relative to the branch joint along the extension direction of the first branch cavity. The first state and the second state can be switched during the movement of the loading clutch component. In the first state, the pre-embedded conduit can move back and forth relative to the branch joint under the action of a first external force; in the second state, the pre-embedded conduit can move back and forth relative to the branch joint under the action of a second external force, wherein the second external force is greater than the first external force.

5. The support system according to claim 2, characterized in that, The elastic seal is located on the distal side of the first branch cavity. The distal end of the elastic seal is recessed towards the proximal end to form a recessed cavity, such that the elastic seal includes an elastic bottom wall located on the proximal side and an elastic side wall surrounding the periphery of the elastic bottom wall. The first through hole is provided on the elastic bottom wall.

6. The support system according to claim 1, characterized in that, The outer surface of the pre-embedded conduit is provided with a conduit limiting member. When the pre-embedded conduit passes through the loading clutch component, the conduit limiting member is located on the distal side of the loading clutch component, and the maximum diameter of the conduit limiting member is greater than the distal inner diameter of the loading clutch component.

7. The support system according to claim 6, characterized in that, The catheter limiting member is disposed on the outer periphery of the pre-embedded catheter. The catheter limiting member includes a proximal section and a distal section connected axially. The outer diameter of the proximal section is set to be equal, and the outer diameter of the distal section gradually decreases from the point where it is connected to the proximal section to the distal end.

8. The support system according to claim 6, characterized in that, It also includes a baffle plate, which is placed inside the branch joint and located on the proximal side of the conduit limiting member. The baffle plate has a second through hole through which the pre-embedded conduit can pass, and the diameter of the second through hole is smaller than the maximum diameter of the conduit limiting member.

9. The support system according to claim 1, characterized in that, The pre-embedded conduit includes a tube body, which includes a proximal segment and a distal segment connected axially, wherein the hardness of the proximal segment is greater than that of the distal segment.

10. The support system according to any one of claims 1 to 9, characterized in that, It also includes a traction member, one end of which is connected to the branch joint, and the other end of which is detachably connected to the loading clutch member extending from the branch joint.

11. The support system according to any one of claims 1 to 9, characterized in that, The outer diameter of the distal portion of the loading clutch component gradually decreases from near to far, such that the distal end of the loading clutch component covers the outer periphery of the pre-embedded conduit; and / or, a metal ring is fitted onto the distal end of the loading clutch component.

12. The support system according to any one of claims 1 to 9, characterized in that, The loading clutch component includes a loader clutch tube and a loader connector connected to the proximal end of the loader clutch tube. The loader clutch tube can be inserted into the first branch cavity, and the loader connector is connected to the branch connector.

13. The support system according to claim 12, characterized in that, The first branch cavity is provided with a fixed connection part at its proximal end, and the loader connector is provided with a connection part adapted to the fixed connection part. When the loader clutch tube is inserted into the first branch cavity, the fixed connection part and the connection part are detachably connected.

14. The support system according to claim 1, characterized in that, The covered stent has a window area on its side through which the pre-embedded conduit can pass. The pre-embedded conduit includes a tube body, which includes a main body section, a distal end section, and a pre-bent section connecting the distal end section and the main body section. The pre-bent section is bent to one side relative to the axis of the main body section. The pre-bent section has a radially opposite large bend side and a small bend side. Under the loaded state with applied radial constraint force, at least a portion of the small bend side is opposite to and abuts against the distal end edge of the window area. The distal end section is located outside the covered stent. After the main body section passes through the inner cavity of the covered stent, its proximal end passes through the delivery handle. After the applied radial constraint force is removed, the proximal end of the pre-embedded conduit is rotated, and the pre-bent section rotates accordingly, such that its large bend side is opposite to at least a portion of the covered stent, while the small bend side deflects toward the side away from the covered stent, and the distal end section extends toward the side away from the covered stent.

15. The support system according to claim 1, characterized in that, The membrane support includes a main support, branch supports, and a connecting membrane sleeve connecting the main support and the branch supports. The branch supports are configured to be movable relative to the main support, and the movable branch supports can be disposed inside or outside the outer wall of the main support. When internally mounted, the connecting membrane sleeve is concave; when externally mounted, the connecting membrane sleeve is convex. The branch supports have at least a pre-loaded state relative to the main support. In the pre-loaded state, the branch supports are at least partially concave and inclined relative to the main support toward the distal end. In the loaded state with applied radial constraint force, at least a portion of the small bend side abuts against the distal end of the inclined outlet.

16. The support system according to claim 14, characterized in that, It also includes a restraint assembly, which includes a restraint member disposed on the outer periphery of the covered stent for radially compressing the covered stent, and a restraint wire connected to the restraint member for maintaining the radial compression of the covered stent. The restraint wire is located on one side of the pre-embedded conduit in the circumferential direction. Under the loaded state with radial restraint applied, the pre-bent section extends out from the outlet of the restraint member, and at least a portion of the small bend side abuts against the outlet of the restraint member. The distal section is located on the outside of the restraint member.

17. The support system according to claim 16, characterized in that, Under the loaded state with radial constraint force applied, at least a portion of the restraint member at the outlet covers and adheres tightly to the outer periphery of the pre-embedded conduit to form a circumferential constraint on the pre-embedded conduit.