A pre-fenestrated branched guidewire guidance system for the aorta

Abstract

This invention provides an aortic pre-fenestration branch guidewire guidance system, comprising a central catheter, a capture ring, and a sliding cannula. The capture ring is connected to the outer wall of the central catheter. The sliding cannula is coaxially sleeved on the outside of the central catheter and can slide along the axial direction of the central catheter. When the sliding cannula moves proximally, the capture ring is released from the constraint of the sliding cannula and unfolds radially outward of the central catheter, thereby forming a capture opening that can accommodate the target guidewire. When the sliding cannula moves distally, the sliding cannula radially compresses the capture ring in its unfolded state, forcing the capture ring to undergo radial compression deformation. The radial compression deformation of the capture ring reduces the cross-sectional area of ​​the portion surrounding the target guidewire, thereby clamping the target guidewire and improving the success rate.

Description

Technical Field

[0001] This utility model relates to the field of guidewire guidance technology, and in particular to a guidewire guidance system for aortic pre-fenestration branch. Background Technology

[0002] In aortic diseases, especially thoracoabdominal aortic aneurysms, when the lesion involves important visceral branches such as the celiac trunk, superior mesenteric artery, and renal artery, the core challenge in treatment is ensuring effective blood flow restoration to these branch vessels while isolating the aneurysm. Endovascular repair, due to its minimally invasive advantages, has become the mainstream treatment method for such diseases. Among them, pre-fenestration technology, by pre-creating a window corresponding to the branch artery on the aortic endovascular stent graft, achieves the restoration of branch blood flow through the window while isolating the aneurysm, and is an important technique for handling complex anatomical morphologies.

[0003] The key to the success of this technology lies in the ability to precisely introduce a target guidewire from an upper limb artery (such as the brachial or radial artery) through a window on the stent after the stent is released and positioned, and then further select it into the opening of the target visceral branch artery, thereby establishing a stable target guidewire pathway and creating conditions for subsequent implantation of a bridging stent.

[0004] Currently, after aortic stent placement via the femoral artery approach, the surgeon must then use the upper limb artery approach, under X-ray fluoroscopy, to manipulate a selective catheter and its target guidewire, attempting to guide it through the stent window and locate the opening of a small branch artery within the aortic aneurysm sac. This process essentially relies on the surgeon's exceptional dexterity, rich spatial imagination, and extensive experience. Utility Model Content

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing an aortic pre-fenestration branch guidewire guidance system that improves the success rate.

[0006] To achieve the above objectives, this utility model provides the following technical solution: A pre-fenestrated aortic branch guidewire guidance system includes: Central catheter; A capture ring, the capture ring being connected to the outer wall of the central conduit; A sliding sleeve, which is coaxially sleeved outside the central conduit and can slide along the axial direction of the central conduit; When the sliding sleeve moves towards the proximal end, the capture ring is released from the constraint of the sliding sleeve and unfolds radially outside the central catheter, thereby forming a capture port that can accommodate the target guidewire. When the sliding sleeve moves toward the distal end, the sliding sleeve radially compresses the capture ring in the unfolded state, forcing the capture ring to undergo radial compression deformation; The radial compression deformation of the capture ring causes a reduction in its cross-sectional area surrounding the target guidewire, thereby clamping the target guidewire.

[0007] In a preferred embodiment, the capturing ring includes a metal wire that forms the capturing port.

[0008] In a preferred embodiment, the metal wire is configured to be accommodated between the sliding sleeve and the central conduit; The remaining portion of the metal wire that is not accommodated between the sliding sleeve and the central conduit constitutes the effective maintenance portion of the capture port; The effective holding portion of the capture port decreases as the sliding sleeve moves, resulting in a corresponding decrease in the cross-sectional area of ​​the capture port.

[0009] In a preferred embodiment, the number of the capture rings is multiple, and they are arranged circumferentially along the central conduit.

[0010] In a preferred embodiment, the central catheter includes a main body segment and a flexible segment; The flexible segment is connected to the distal end of the main body segment; The capture ring is connected to the main body segment of the central conduit, and the capture ring is positioned close to the flexible segment.

[0011] In a preferred embodiment, the flexible segment is provided with a developing ring.

[0012] In a preferred embodiment, the central catheter further includes a handle connected to the proximal end of the main body segment.

[0013] In a preferred embodiment, the handle is further provided with a locking mechanism, which is connected to the sliding sleeve.

[0014] Compared with existing technologies, this technical solution has the following advantages: By unfolding the capture ring to form a capture port facing the proximal end, a clearly defined target area with an area much larger than the branch artery opening is actively constructed within the aortic lumen. This greatly reduces the precision requirements for selecting the guidewire into the branch, solves the problems of inaccurate window and branch opening positioning and the heavy reliance on operator experience for success rate, and significantly improves the first-pass rate and overall success rate of establishing branch guidewire access.

[0015] The system moves along a pre-positioned guidewire within the branch. After capturing the target guidewire, it can be stably and directionally dragged into the target branch along this defined path. This mechanism completely eliminates the path uncertainty and repeated trial and error inherent in traditional antegrade blind selection, thereby significantly shortening the time required to establish access. Consequently, it reduces the intraoperative X-ray radiation exposure dose and contrast agent usage, effectively mitigating the problems of prolonged operation time, radiation damage, and increased risk of contrast agent-induced nephropathy.

[0016] The aforementioned active capture and directional guidance mechanism avoids prolonged and repeated probing and mechanical stimulation of the target guidewire near the fragile aortic intima and branch openings. This significantly reduces the risk of serious complications such as iatrogenic intimal injury, distal embolism caused by atherosclerotic plaque detachment, and even the induction of new aortic dissection, making the surgical procedure safer.

[0017] The entire process, including capture, guidewire capture, temporary fixation, and directional delivery, is integrated into a simple and intuitive operation: the axial sliding of the sliding cannula. Operators can easily and controllably complete the entire procedure using the operating handle and locking mechanism. This significantly reduces over-reliance on the operator's personal touch, spatial imagination, and extensive experience, thus shortening the learning curve. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the capture ring deployment state of the aortic pre-fenestration branch guidewire guidance system of this utility model; Figure 2 This is a schematic diagram of the capture ring constraint state of the aortic pre-fenestration branch guidewire guidance system of this utility model; Figure 3 This is a schematic diagram of the structure of the central catheter described in this utility model; Figure 4 This is a schematic diagram of the capture ring described in this utility model.

[0019] In the diagram: 100 central catheter, 110 main body segment, 120 flexible segment, 130 handle, 140 imaging ring, 200 capture ring, 200a capture port, 210 metal wire, 300 sliding sleeve, 300a distal port, 400 track guidewire, 500 target guidewire. Detailed Implementation

[0020] The following description is intended to disclose the present invention so that those skilled in the art can implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art. The basic principles of the present invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the present invention.

[0021] Please refer to Figure 1 and Figure 2 An embodiment of this utility model provides an aortic pre-fenestration branch guidewire guidance system, comprising: Central catheter 100; A capture ring 200 is connected to the outer wall of the central conduit 100; A sliding sleeve 300 is coaxially sleeved outside the central conduit 100 and can slide along the axial direction of the central conduit 100. When the sliding sleeve 300 moves towards the proximal end, the capture ring 200 is released from the constraint of the sliding sleeve 300 and unfolds radially outside the central catheter 100, thereby forming a capture port 200a, which can accommodate the target guidewire 500 introduced from the upper limb artery. When the sliding sleeve 300 moves toward the distal end, the sliding sleeve 300 radially compresses the capture ring 200 in the unfolded state, forcing the capture ring 200 to undergo radial compression deformation. The radial compression deformation of the capture ring 200 causes a reduction in its cross-sectional area around the target guidewire 500, thereby clamping the target guidewire.

[0022] The capture opening 200a formed by the unfolding of the capture ring 200 is used to accommodate the target guidewire 500, which solves the core problems of inaccurate window and branch opening positioning, high operation difficulty, and reliance on experience for success rate. It greatly improves the first-pass success rate and reduces the over-reliance on the surgeon's personal experience.

[0023] This system is delivered and positioned via the femoral artery approach along a pre-positioned guidewire 400. After capturing the target guidewire 500, the entire system (along with the clamped target guidewire) can be stably and directionally pushed retrogradely into the target branch vessel along this guidewire 400. This path is deterministic and controllable, completely eliminating the uncertainty and repeated attempts of traditional antegrade blind path selection, thereby significantly shortening the access establishment time, reducing intraoperative radiation exposure and contrast agent usage, and correspondingly solving the problems of increased operation time, radiation, and contrast agent usage.

[0024] The aforementioned active capture and directional guidance mechanism avoids the need for the target guidewire 500 to search and puncture repeatedly near the branch artery opening and on the intima of the aortic aneurysm cavity for a long time, greatly reducing the risk of damaging the vascular intima, causing plaque detachment, or inducing new dissection, and improving the overall safety of the operation.

[0025] The target capture guidewire 500 and directional delivery functions are integrated into a single instrument, which can be completed seamlessly through the simple axial sliding of the sliding sleeve 300. This specifically addresses the pain points mentioned in the background technology, such as the lack of dedicated instruments and the mismatch of existing tool functions, enabling the standardization and simplification of this key step, which is conducive to the popularization and promotion of this advanced technology.

[0026] like Figure 1 As shown, the central catheter 100 has a hollow structure, which allows it to be threaded onto a guidewire 400. During the procedure, the guidewire 400 is pre-selected via the contralateral femoral artery and placed within the target visceral branch vessel. The central catheter 100 is fitted onto the guidewire 400 through its hollow structure, thereby enabling the guidance system to move along the guidewire 400.

[0027] In a preferred embodiment, the inner diameter of the central conduit 100 is configured to allow a 0.018-inch or 0.035-inch guidewire 400 to pass through.

[0028] like Figure 3 As shown, the central conduit 100 includes a main body section 110, a flexible section 120, and a handle 130 coaxially connected. The main body section 110, the flexible section 120, and the handle 130 are all hollow structures to form a hollow central conduit 100.

[0029] The handle 130 is connected to the proximal end of the main body segment 110 and is located outside the body. It provides the operator with a gripping point for operation.

[0030] The main body segment 110 is made of a polymer material with a certain degree of rigidity and excellent pushing support, such as polyether block amide, nylon, or polyimide. When the operator applies pushing force through the handle 130, this segment can efficiently transmit the axial pushing force to the distal end, ensuring the stable advancement of the entire guidance system.

[0031] The flexible segment 120 is connected to the distal end of the main body segment 110, forming the front end portion of the central catheter 100. It is made of a more compliant material (such as thermoplastic polyurethane). When delivered through tortuous blood vessels such as the femoral artery, the flexible segment 120 conforms to the anatomical shape, effectively reducing delivery resistance, improving permeability, and minimizing the risk of damage to the vascular intima. Its distal end is typically designed with a smooth, tapered tip to further enhance the safety of its guidance and passage.

[0032] refer to Figure 3The flexible segment 120 has a radiopaque ring 140 on its outer wall to facilitate the positioning of the front end of the central catheter 100 under X-ray. Specifically, the radiopaque ring 140 is made of platinum-iridium alloy, tantalum, or other high atomic number materials and surrounds the flexible segment 120. It is typically fixed by hot pressing, overmolding, or medical-grade biocompatible adhesive to ensure that it does not shift or fall off during repeated pushing, twisting, and blood flushing.

[0033] The main body segment 110 and the flexible segment 120 are connected coaxially and smoothly without steps through thermal fusion, laser welding or medical-grade adhesive.

[0034] like Figure 3 As shown, the capture ring 200 is connected to the main body segment 110 of the central conduit 100, and the capture ring 200 is positioned close to the flexible segment 120. Since the material hardness and structural rigidity of the main body segment 110 are significantly higher than those of the flexible segment 120, it can provide a stable mechanical attachment basis for the repeated unfolding and retraction of the capture ring 200.

[0035] The capturing ring 200 includes a metal wire 210, which forms a ring structure. When the ring structure is unfolded, the internal space defined by it forms the capturing port 200a.

[0036] For example, the metal wire 210 is a continuous ring wire, which is fixed to the outer wall of the main body segment 110 by at least one connection point (such as welding).

[0037] The metal wire 210 is preferably made of a superelastic nickel-titanium alloy. The nickel-titanium alloy has excellent shape memory and superelasticity properties, which allows it to almost completely return to the preset unfolded shape once the constraint is released after being fully constrained and retracted by the sliding sleeve 300. The capture ring 200 unfolds to form a capture port 200a for accommodating the target guide wire 500.

[0038] like Figure 1 and Figure 4 As shown, the number of capture rings 200 is multiple (e.g., two, three, or more). These capture rings 200 are arranged at circumferential intervals along the central conduit 100. This significantly increases the effective capture area and spatial coverage. Regardless of the circumferential angle from which the target guidewire 500 approaches the central conduit 100, its tip is very likely to fall into one of the capture rings 200, thereby greatly improving the capture success rate and reducing the precision required for the operator to manipulate the angle of the target guidewire 500.

[0039] like Figure 1 and Figure 2As shown, the sliding sleeve 300 is coaxially sleeved outside the central conduit 100 and can slide along the axial direction of the central conduit 100.

[0040] Specifically, the inner diameter of the sliding sleeve 300 is slightly larger than the outer diameter of the central catheter 100, forming a clearance fit. This ensures that the sliding sleeve 300 can slide freely back and forth without significant blood backflow. This is achieved through precision machining, ensuring that the diameter and roundness of the sliding sleeve 300 and the central catheter 100 meet medical-grade tolerance standards.

[0041] The tube body of the sliding sleeve 300 is made of a polymer material with certain rigidity, wear resistance and good biocompatibility. Preferably, the material is polyether block amide, polyimide or nylon.

[0042] The handle 130 is also provided with a locking mechanism (not shown in the figure). The locking mechanism is connected to the proximal end of the sliding sleeve 300 and is used to lock the sliding sleeve 300 at a certain axial position on the central conduit 100. For example, the sliding sleeve 300 exerts radial pressure on the capture ring 200 and the capture ring 200 clamps the target guide wire 500.

[0043] Specifically, the locking mechanism includes a locking knob that threads with the handle 130. The proximal extension of the sliding sleeve 300 passes through this knob. When the knob is tightened clockwise, its internal conical surface or washer radially presses against the extension, generating significant static friction to secure it. Tightening it counterclockwise releases the lock.

[0044] like Figure 1 As shown, when the sliding sleeve 300 moves to the distal end, its distal port 300a first contacts and begins to radially compress the capture ring 200 in the unfolded state.

[0045] The distal port 300a of the sliding sleeve 300 acts as a rigid annular extrusion surface, applying a concentrated radially inward load to the capturing ring 200. Under this load, the connection point between the capturing ring 200 and the central conduit 100 first undergoes radial elastic bending deformation, its radius of curvature decreases, and it begins to be pressed against the outer wall of the central conduit 100.

[0046] As the sliding sleeve 300 continues to advance distally, its radial squeezing effect on the capturing ring 200 starts from the connection point and is sequentially transmitted and extended distally along the capturing ring 200. This process is similar to a moving pressure roller that gradually and continuously rolls the capturing ring 200 into the annular interlayer gap formed by the inner wall of the sliding sleeve 300 and the outer wall of the central guide tube 100.

[0047] During this process, the remaining continuous portion of the metal wire 210 that has not yet been covered and compressed by the sliding sleeve 300 continues to define and maintain the instantaneous shape and open state of the capture port 200a because it still maintains its unfolded shape, thus constituting the effective maintenance portion of the capture port 200a.

[0048] As the aforementioned winding process proceeds, the length of the metal wire constituting the effective holding portion of the capture opening 200a continuously decreases. This directly leads to a corresponding, gradual reduction in the maximum cross-sectional area of ​​the capture opening 200a enclosed by the remaining metal wire. This area contraction causes the containment space of the capture opening 200a over the target guide wire 500 to gradually tighten. When the area decreases to less than the outer diameter of the target guide wire, the remaining effective holding portion of the metal wire will generate a uniform, continuously increasing radial compressive stress (i.e., clamping force) on the circumference of the target guide wire 500.

[0049] The process of using the guidance system is as follows: Phase 1: Preparation and Delivery Establishing the access route: A vascular sheath is inserted via femoral artery puncture.

[0050] Pre-set track: Establish a pre-set guidewire pathway for the branch vessel. Specifically, a 400-degree track guidewire is pre-selected and placed within the target reconstructed visceral branch vessel.

[0051] System placement: With the capture ring 200 in a closed state completely covered by the sliding cannula 300, insert the central catheter 100 into the body through the vascular sheath along the guide wire 400. Push it under fluoroscopy until the system tip (capture ring area) reaches the window position of the aortic stent.

[0052] Phase Two: Deploying the Capture Port Release the constraint: After confirming that the system position is correct, the operator operates handle 130 and moves the sliding cannula 300 proximally (towards the operator).

[0053] Capture port formation: The sliding sleeve 300 moves backward, releasing the radial constraint on the capture ring 200. The capture ring 200, with its hyperelasticity, automatically expands radially, forming a capture port 200a facing the proximal end within the aortic lumen.

[0054] Phase 3: Target wire capture Insert the target guidewire: Insert the target guidewire 500 via the brachial or radial artery approach and maneuver it through the window of the aortic stent.

[0055] Guide wire insertion: Under fluoroscopy, manipulate the target guide wire 500 so that its tip enters the unfolded capture port 200a.

[0056] Phase 4: Fixed Target Guidewire and Reverse Guidance Holding and fixing: The operator operates the handle 130 and moves the sliding cannula 300 distally (towards the patient). The sliding cannula 300 moves forward, radially compressing and retracting the capture ring 200 to clamp and fix the target guidewire 500.

[0057] Reverse directional pushing: While keeping the target guidewire 500 fixed, the entire guidance system is smoothly pushed distally (towards / in front of the patient's head) along the pre-set track guidewire 400. This action reverses and directionally drags the captured target guidewire 500 into the target branch vessel (target vessel).

[0058] Phase 5: Establishing pathways and system withdrawal Release the guidewire: After the system tip enters the target blood vessel, move the sliding cannula 300 a short distance proximally to slightly unfold the capture ring 200, thereby releasing the held target guidewire 500.

[0059] Establish working access: via an upper limb artery approach, a selective catheter is advanced 500° along the target guidewire to a more distal position within the target vessel. The guidewire is adjusted or exchanged through this catheter to establish a stable and sufficiently supportive working guidewire access for subsequent stent delivery.

[0060] System withdrawal: Move the sliding sleeve 300 to its furthest end, allowing the capture ring 200 to return to a fully closed state. Finally, withdraw the entire guidance system from the body along the guide wire 400.

[0061] The embodiments described above are only used to illustrate the technical ideas and features of this utility model. Their purpose is to enable those skilled in the art to understand the content of this utility model and implement it accordingly. The scope of patent application of this utility model should not be limited by these embodiments. That is, any equivalent changes or modifications made in accordance with the spirit disclosed in this utility model still fall within the patent scope of this utility model.

Claims

1. An aortic pre fenestrated branch wire guide system, characterized in that, include: Central catheter (100); A capture ring (200) is attached to the outer wall of the central conduit (100); A sliding sleeve (300) is coaxially sleeved outside the central conduit (100) and can slide along the axial direction of the central conduit (100); When the sliding sleeve (300) moves towards the proximal end, the capture ring (200) is released from the constraint of the sliding sleeve (300) and unfolds radially outside the central catheter (100) to form a capture port (200a) that can accommodate the target guidewire (500). When the sliding sleeve (300) moves toward the distal end, the sliding sleeve (300) radially compresses the capture ring (200) in the unfolded state, forcing the capture ring (200) to undergo radial compression deformation; The radial compression deformation of the capture ring (200) causes a reduction in the cross-sectional area of ​​the portion surrounding the target guidewire (500), thereby clamping the target guidewire.

2. The aortic pre fenestrated branch wire guide system of claim 1, wherein, The capture ring (200) includes a metal wire (210) that forms the capture port (200a).

3. The aortic pre fenestrated branch wire guide system of claim 2, wherein, The metal wire (210) is configured to be accommodated between the sliding sleeve (300) and the central conduit (100); The remaining portion of the metal wire (210) not accommodated between the sliding sleeve (300) and the central conduit (100) constitutes the effective holding portion of the capture port (200a); The effective holding portion of the capture port (200a) decreases as the sliding sleeve (300) moves, resulting in a corresponding decrease in the cross-sectional area of ​​the capture port (200a).

4. The aortic pre fenestrated branch wire guide system of claim 1, wherein, The number of the capture rings (200) is multiple, and they are arranged circumferentially along the central conduit (100).

5. The aortic pre fenestrated branch wire guide system of claim 1, wherein, The central catheter (100) includes a main body segment (110) and a flexible segment (120). The flexible segment (120) is connected to the distal end of the main body segment (110); The capture ring (200) is connected to the main body segment (110) of the central conduit (100), and the capture ring (200) is positioned close to the flexible segment (120).

6. The aortic pre-fenestration branch guidewire guidance system as described in claim 5, characterized in that, The flexible segment (120) is provided with a developing ring (140).

7. The aortic pre-fenestration branch guidewire guidance system as described in claim 5, characterized in that, The central catheter (100) also includes a handle (130) connected to the proximal end of the main body segment (110).

8. The aortic pre-fenestration branch guidewire guidance system as described in claim 7, characterized in that, The handle (130) is also provided with a locking mechanism, which is connected to the sliding sleeve (300).

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