A ready-to-use endoluminal repair system for treating Stanford type A aortic dissections.

Abstract

This invention discloses an off-the-shelf total endovascular repair system for treating Stanford type A aortic dissection, comprising an ascending aortic stent-type vessel (ascending aortic assembly), a coronary artery branch endovascular stent-covered vessel (coronary assembly), and on-demand implantation of a self-expanding aortic valve (valve assembly). The ascending aortic assembly consists of an ascending aortic segment and a sinus segment. The ascending aortic segment is a endovascular stent-covered vessel with its proximal end anchored to the ascending aorta and its distal end transitioning into a "concave" sinus segment. The anterior ends of the endovascular segment of the concave portion have embedded branches that open into the sinus segment, which is externally a bare metal stent. The coronary artery branch endovascular stent-covered vessel is a "conical" small-diameter endovascular stent-covered vessel, with its proximal end connecting to the embedded branch of the ascending aortic assembly. The distal diameter varies depending on whether the left or right coronary artery is involved. The graft can be connected to the aortic valve assembly as needed. This invention is specifically designed for Stanford type A aortic dissection involving the aortic root, capable of repairing aortic lesions, reconstructing bilateral coronary arteries, and on-demand aortic valve connection. It can be mass-produced for emergency surgery.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an off-the-shelf total endocavitary repair system for treating Stanford type A dissection. Background Technology

[0002] Clinically, over 90% of Stanford type A aortic dissections involve the aortic root, requiring Bentall with ascending aortic arch nose surgery, or coronary artery bypass grafting with sinus repair and ascending aortic arch nose surgery. Several centers have implemented Endo-Bentall procedures by modifying existing endovascular aortic grafts with TAVI valves. However, the anatomical forms of type A aortic dissections are diverse, and approximately 20% of lesions only involve the sinus and coronary arteries, requiring no valve replacement. Preserving the autologous aortic valve is of great significance for the long-term prognosis of patients. Current Endo-Bentall concepts or practices have the following problems: 1. Whether the graft is designed as an integrated unit or a separate unit, it requires destruction of the autologous aortic valve; 2. The integrated design of ascending aortic-aortic valve grafts presents technical challenges in preserving the bioprosthetic valve. Pre-installed dry valves are too expensive, and artificial biomaterial valves are not yet mature enough to completely replace the currently widely used bioprosthetic valves; 3. Modifying the split design of intraluminal aortic grafts + TAVI valves or the ready-made valve method is more suitable for "aortic stenosis lesions". However, aortic valve lesions involving dissection are mostly characterized by annular enlargement, valve insufficiency, and sinus dilation. Most of the autologous valve annulus cannot provide a firm "anchoring" for the graft. Therefore, the commercially available TAVI valves cannot be widely used for valvular lesions caused by dissection.

[0003] Patent application CN202011504274.6 discloses an aortic root stent system. This product includes an aortic stent and a sinus anchoring stent. The aortic stent is positioned on the inner wall of the ascending aorta, and the sinus anchoring stent is attached to the inner wall of the aortic sinus, extending downwards from the sinus-canal junction. The base of the sinus anchoring stent extends medially to form several coronary valve stents attached to the aortic sinus. The outer peripheral surfaces of these coronary valve stents form a clove-like structure, and the inner apex of each stent extends to the outer side of the valve annulus. The ends of all coronary valve stents form an opening for free movement of the valve leaflets. This product's coronary valve stent increases the anchoring area of ​​the entire sinus anchoring stent within the aortic valve, ensuring firm positioning and preventing displacement under blood flow impact, thus improving the stability of the aortic root anchoring system within the aortic valve. However, this graft cannot resolve lesions involving the aortic valve, and due to the relatively large space in the sinus region, it is difficult to "overselect" both coronary arteries during operation.

[0004] Patent application number 202110859381.9 discloses a graft suitable for treating ascending aortic root diseases. It includes an ascending aortic stent and a valve prosthesis comprising a valve stent and an artificial valve leaflet. The valve stent includes: a main stent with a leaflet fixing portion fixedly connected to its inner side, an artificial valve leaflet connected to the leaflet fixing portion, and a valve clip fixedly connected to its outer side to clamp an autologous valve leaflet between the valve clip and the main stent during use; an arterial stent junction portion connected to one end of the main stent and configured to connect with the ascending aortic stent; and a valve annulus contact portion connected to the other end of the main stent and configured to make sealing contact with an autologous valve annulus. The system is detachable, but the "valve clip," the connection device between the ascending aortic graft and the aortic valve, is complex to manufacture, making surgery more difficult when performed in the sinus region. The complex device may increase the afterload of the left ventricle postoperatively. The valve annulus contact portion, which is connected to the other end of the main stent and configured to seal with the autologous valve annulus to prevent direct contact between the main stent and the autologous valve annulus and to prevent blood backflow into the left ventricle, is consistent with the design of the "aortic stenosis interventional valve" and is more suitable for "aortic stenosis lesions." Type A dissections involving the aortic valve are mostly due to valve insufficiency, and autologous valve annulus is mostly unable to provide a firm "anchoring" for the graft. Summary of the Invention

[0005] To address the technical problems raised in the background, this invention provides an off-the-shelf total endovascular repair system for treating Stanford type A aortic dissection, aiming to repair aortic lesions, reconstruct bilateral coronary arteries, and determine whether to connect aortic valve components depending on whether the lesion involves the aortic valve, thereby implementing Endo-Bentall or endovascular sinus repair + coronary artery reconstruction.

[0006] The technical solution adopted in this invention is: An off-the-shelf endovascular repair system for treating Stanford type A aortic dissection, comprising a primary core and secondary supporting modules; The primary core component includes the ascending aortic assembly, the coronary artery assembly, and the aortic valve assembly; the secondary supporting modules include the delivery unit and auxiliary tools. The ascending main component includes an ascending main stent with a covered stent in the ascending main segment, an embedded branch of the ascending main component, an "8" mark at the junction of the ascending main part and the sinus duct part of the ascending main component, a recessed part of the sinus duct part of the ascending main component, and a bare stent in the sinus duct part of the ascending main component. The "8" mark at the junction of the ascending main part and the sinus duct part of the ascending main component is located at the junction of the covered stent in the ascending main segment of the ascending main stent and the bare stent in the sinus duct part of the ascending main component. The recessed part of the sinus duct part of the ascending main component is located at the proximal end of the bare stent in the sinus duct part of the ascending main component. The embedded branch of the ascending main component is connected to the covered stent in the ascending main segment of the ascending main stent. The coronary artery assembly includes a coronary artery assembly bridging portion and a coronary artery portion; one end of the coronary artery assembly bridging portion is connected and fixed to the embedded branch of the ascending aorta assembly, and the other end is connected to the coronary artery portion of the coronary artery assembly to form a blood flow channel from the ascending aorta to the coronary vessels; The aortic valve assembly includes a valve stent, a tricuspid valve of the valve stent, a positioning stent, an outflow tract anchoring region, and an inflow tract anchoring region. The tricuspid valve of the valve stent is embedded inside the valve stent. The positioning stent includes a corolla stent and a long U-shaped stent. The outflow tract anchoring region is located at the distal end of the valve stent, and the inflow tract anchoring region is located at the proximal end of the valve stent. The delivery assembly includes a valve assembly delivery tip, a valve assembly loading rod, a dividing pad, a long U-shaped bracket lock, a delivery outer sheath, and a delivery push rod. The valve assembly delivery tip is fixed to the front end of the delivery push rod, the delivery outer sheath is sleeved on the outside of the delivery push rod, and the valve assembly loading rod is adapted to the valve stent for loading and releasing control of the valve assembly. The dividing pad is fixed to the loading rod and is used to separate the valve stent from the positioning stent when loading the valve assembly. The long U-shaped bracket lock is located at the end of the loading rod and is used to hook the long U-shaped bracket when loading the valve assembly. The auxiliary tool is a valve depressor, which is compatible with both the leaflet and the valve stent of the valve assembly, and is used for positioning and pressing the leaflet during the assembly of the valve assembly.

[0007] Preferably, the bridging portion of the coronary artery assembly is made of a flexible material coated with polytetrafluoroethylene, and the diameter of the coronary artery portion of the coronary artery assembly is 4-6 mm.

[0008] Preferably, the valve stent is a self-expanding nickel-titanium alloy stent, the lobule of the valve component valve stent is made of bovine pericardium material, and the edge of the lobule of the valve component valve stent is provided with reinforcing sutures to enhance the connection stability between the lobule and the valve stent.

[0009] Preferably, both the outflow tract anchoring area and the inflow tract anchoring area of ​​the valve assembly are provided with a roughened polyetheretherketone coating, the surface roughness Ra of the roughened polyetheretherketone coating being 1.5-3.0 μm, which is used to enhance the friction between the anchoring area and the blood vessel wall.

[0010] Preferably, the valve assembly delivery tip has a built-in tungsten alloy imaging marker, and the figure-eight marking at the junction of the ascending main part and the sinus duct part of the ascending main assembly is a tantalum wire braided structure, used for imaging positioning during the operation.

[0011] Preferably, the outer sheath of the delivery device is made of nylon-12 material, and the wall thickness of the outer sheath is 0.15-0.2mm; the delivery push rod is a stainless steel hollow tube, the inner diameter of the delivery push rod is adapted to the outer diameter of the guidewire used in interventional surgery, and a guidewire channel is formed inside for the guidewire to pass through.

[0012] Preferably, the dividing gasket between the valve stent and the positioning stent is made of silicone rubber, and the thickness of the dividing gasket between the valve stent and the positioning stent is 0.3-0.5 mm.

[0013] Preferably, the corolla support of the valve assembly positioning stent is located at the distal end of the positioning stent and has a petal-like unfolding structure; the long U-shaped support of the valve assembly positioning stent is located at the proximal end of the positioning stent, and its U-shaped structure extends to the left ventricular outflow tract to assist in the anchoring of the valve assembly inflow tract.

[0014] Compared with the prior art, the beneficial effects of the present invention are: The graft is designed as an "ascending aortic stent-type vessel with embedded branches and a concave tail end (ascending aortic component)," and two "conical coronary branch covered stent vessels (coronary components)." Depending on whether aortic valve replacement is required, an "aortic valve component with a positioning stent (valve component)" can be implanted on-site. The surgeon can choose different surgical techniques based on whether the lesion requires aortic valve repair. The ascending aortic component uses the aortic-sinus junction before the brachiocephalic trunk as the anchoring zone; the valve component uses the left ventricular outflow tract as the first anchoring zone, the "concave portion" of the ascending aortic component as the second anchoring zone, and the positioning stent as the auxiliary anchoring zone.

[0015] Compared to the "integrated valved vascular graft" design, the valveless ascending aortic component can be loaded onto a thinner delivery device and delivered via the femoral artery before release. After graft release, the two inlaid branch openings on either side of the sinusoidal segment ensure coronary blood flow. The surgeon can easily insert guidewires through the inlaid branches via the left / right brachial arteries, selecting both coronary arteries before implanting the coronary component to reconstruct bilateral coronary blood flow. The bare metal stent in the sinusoidal segment supports the collapsed intimal flap of the dissected true lumen, ensuring blood flow in the ascending aorta, and provides space for the connection of the coronary component. It also anchors to the sinus to prevent displacement of the ascending aortic component. When the autologous aortic valve is severely affected and requires valve reconstruction, a valve component can be connected. This component is self-expanding and consists of a leaflet stent and a positioning stent. The leaflets are made from porcine / bovine pericardium (novel biomaterials can also be considered), attached to a nickel-titanium alloy stent, replacing the original valve. The positioning stent consists of three nickel-titanium alloy "crown-shaped" metal rings and three "long U-shaped" metal rings. After deployment, the "long U-shaped" metal rings are anchored in the left ventricular outflow tract, and the "crown-shaped" metal rings are fixed in the aortic sinus, providing a reference for precise positioning of the valve stent. The proximal end of the valve stent connects with the "recessed portion" of the ascending aortic assembly, relying on magnification to integrate with the ascending aortic assembly, while the distal end is firmly anchored by the positioning stent, achieving "dual anchoring + sinus fixation" to replace the function of the autologous valve.

[0016] Using this patent, the decision to connect the aortic valve assembly can be flexibly made based on the degree of involvement of the aortic root. A bare metal stent at the periphery of the sinus duct tail supports the sinus, while the interior is a "recessed" covered stent. This part can connect to the aortic valve assembly to repair lesions involving the "aortic valve-coronary artery-ascending aorta," implementing Endo-Bentall. If the lesion does not involve the valve, the aortic valve assembly is not connected, thus not interfering with the movement of the autologous aortic valve leaflets, and endovascular ascending aortic repair + sinusoplasty + coronary artery reconstruction is performed.

[0017] The present invention will be explained in detail below with reference to the accompanying drawings and specific embodiments. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the valve assembly structure of the present invention; A) Overall view of the valve assembly; B) Frontal view of the "corolla stent" and "long U-shaped stent" of the positioning stent; C) Top view of the positioning stent. Figure 2 This is a schematic diagram of the valve assembly of the present invention. Figure 3 This is a schematic diagram of the ascending main component and the coronary artery component of the present invention; Figure 4 This is a schematic diagram showing the insertion path of each component in this invention; Figure descriptions: 1. Outflow tract anchoring area of ​​the valve assembly; 2. Trilobite of the valve stent in the valve assembly; 3. Corolla support of the positioning stent in the valve assembly; 4. Long U-shaped support of the positioning stent in the valve assembly; 5. Inflow tract anchoring area of ​​the valve assembly; 6. Tip of the valve assembly delivery system; 7. Loading rod of the valve assembly; 8. Dividing spacer between the valve stent and the positioning stent; 9. Long U-shaped stent locking buckle; 10. Outer sheath of the delivery system; 11. Delivery system push rod; 12. Valve stent; 13. Positioning stent; 14. Ascending main stent, ascending main segment covered stent; 15. Embedded branch of the ascending main assembly; 16. Figure-eight mark at the junction of the ascending main segment and the sinusoidal segment of the ascending main assembly; 17. Recessed portion of the sinusoidal segment of the ascending main assembly; 18. Bare stent in the sinusoidal segment of the ascending main assembly; 19. Bridging portion of the coronary artery assembly; 20. Coronary artery segment of the coronary artery assembly; 21. Valve pressor. Detailed Implementation

[0019] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] like Figure 1-4 As shown, I. Primary Core Entities (Core Functional Modules) (a) Main component (support and positioning core) Ascending aortic stent 14: The core support structure at the distal end of the ascending aortic component covers the lesion area of ​​the ascending aorta to block blood flow in the false lumen, while providing a mounting base for the embedded branch 15 of the ascending aortic component to maintain the patency of the ascending aortic lumen.

[0021] The ascending main component has an embedded branch 15: which is connected to the ascending main segment covered stent 14 of the ascending main stent to ensure smooth blood flow in the branch vessels, and at the same time serves as the connecting carrier of the coronary component bridging part 19.

[0022] Figure-eight marker 16 at the junction of the ascending main segment and the sinus duct of the ascending main component: Located at the junction of the covered stent 14 of the ascending main segment of the ascending main stent and the bare stent 18 of the sinus duct of the ascending main component, it adopts a tantalum wire braided structure and serves as an imaging positioning reference to help the surgeon confirm the relative position of the ascending main component, the valve component, and the coronary artery ostium.

[0023] The recessed portion 17 of the sinus canal of the ascending main component is a continuation of the membrane stent of the ascending main component. The diameter of the tube is 2 / 3 to 1 / 2 of that of the ascending main component. It provides anchorage for the outflow tract anchoring area (1) of the valve component. The outflow tract anchoring area (1) of the valve component is anchored to the recessed portion (17) of the sinus canal of the ascending main component by magnification to achieve precise connection between the valve component and the ascending main component.

[0024] The bare stent 18 in the sinus duct section of the ascending main component is a proximal support structure of the ascending main component. It adopts a bare stent design to enhance the fit stability with the aortic wall and avoid excessive compression of the anatomical shape of the sinus duct by the covered structure. At the same time, it works with the figure-eight marker 16 to achieve precise positioning of the ascending main component.

[0025] (II) Coronary Artery Components (Coronary Blood Flow Protection) Coronary artery assembly bridging section 19: Made of flexible polytetrafluoroethylene film, one end is connected and fixed to the embedded branch 15 of the ascending main assembly, and the other end is connected to the coronary artery section 20 of the coronary artery assembly, forming a blood flow channel of "ascending main assembly - coronary artery assembly", which can adapt to changes in anatomical angle near the coronary artery opening and reduce traction on the coronary artery vessels.

[0026] Coronary artery component 20: outer diameter is 3-5mm, which is adapted to the anatomical diameter of the main coronary artery and is anchored to the left and right main coronary arteries by magnification.

[0027] (III) Aortic valve assembly (valve function repair / preservation) Valve stent 12: A self-expanding nickel-titanium alloy stent is used to provide an installation support frame for the trilobal leaflet (2) of the valve component stent. After release, the distal end connects with the recessed part (17) of the sinus duct of the ascending master component through the valve component outflow tract anchoring area (1) and is anchored to the recessed part (17) of the sinus duct of the ascending master component by magnification. The proximal end is anchored to the left ventricular outflow tract through the valve component inflow tract anchoring area (5).

[0028] The three-leaf valve of the valve stent (2) is embedded in the valve stent (12), made of bovine pericardium material, with reinforced sutures on the edge, simulating the three-leaf structure of the natural aortic valve in the human body, so as to realize the one-way flow of blood from the left ventricle to the ascending aorta and prevent blood backflow.

[0029] Positioning stent (13): Valve assembly auxiliary positioning frame, including the corolla stent (3) of the valve assembly positioning stent and the long U-shaped stent (4) of the valve assembly positioning stent, which work together with the valve stent (12) to achieve multi-dimensional fixation of the valve assembly and avoid valve displacement.

[0030] The corolla support (3) of the valve assembly positioning stent: located at the distal end of the positioning stent 13, unfolds in a petal shape to enhance the stability of the valve annulus.

[0031] The long U-shaped stent 4 of the valve component positioning stent is located at the proximal end of the positioning stent 13, and is arranged alternately with the petals, extending to the left ventricular outflow tract to reinforce the anchoring of the valve component inflow tract anchoring area (5).

[0032] Valve assembly outflow tract anchoring area 1: Located at the distal end of the valve stent 12, the surface is provided with a roughened polyether ether ketone coating with a roughness Ra of 1.5-3.0 μm. By enhancing the friction with the recessed portion 17 of the ascending main component sinus duct, the valve assembly is restricted from shifting towards the outflow tract.

[0033] Valve assembly inflow tract anchoring area 5: Located at the proximal end of valve stent 12, the surface is also coated with a roughened polyether ether ketone coating, which fits the wall of the left ventricular outflow tract below the aortic valve annulus. It fits tightly with the inflow tract wall through radial support force, restricting the valve assembly from moving in the direction of the inflow tract.

[0034] Secondary and secondary supporting modules (conveying and auxiliary operations) (a) Conveyor assembly (core module conveying) Valve assembly delivery tip (6): Located at the front end of the delivery assembly, it adopts a blunt and smooth design to reduce vascular wall scratches. It has a built-in tungsten alloy imaging marker. The operator can use imaging to determine the position of the delivery tip and guide the delivery device to pass smoothly through anatomical structures such as the aortic arch and ascending aorta.

[0035] Valve component loading rod (7): Adapted to the valve stent (12), used to load the compressed valve component, ascending main component, and coronary artery component into the delivery device sheath (10), and at the same time, during the component release process, the gradual unfolding speed of the valve stent (12) and positioning stent (13) is controlled by the retraction action.

[0036] Valve stent and positioning stent dividing pad (8): Made of silicone material, 0.3-0.5mm thick. It serves as the dividing line between the valve stent (12) and the positioning stent (13) during installation.

[0037] Long U-shaped stent latch (9): Located at the end of the loading rod (7), used to hook the long U-shaped stent when loading the valve assembly.

[0038] The outer sheath (10) of the delivery device is made of nylon-12 material with a wall thickness of 0.15-0.2mm. It is fitted on the outside of the delivery device push rod (11) and contains the core functional modules (ascending aorta, coronary artery, valve assembly) in a compressed state during delivery, protecting the components from friction damage to the blood vessel wall. When released, the components are gradually exposed by retraction.

[0039] Delivery push rod (11): It is a stainless steel hollow tube with an inner diameter that matches the outer diameter of the guidewire. One end is connected to the valve assembly delivery tip head (6), and the other end is connected to the rear operating handle to provide axial pushing force for the delivery device. The operator pushes the push rod to deliver the core functional module to the target anatomical position. The built-in guidewire channel is compatible with guidewire guidance.

[0040] (ii) Auxiliary tools (component assembly aids) Valve depressor (21): It is adapted to the leaflet (2) and valve stent (12) of the valve assembly and is used to compress the valve stent (12) in the conveyor during the valve assembly process. It can be removed after assembly without affecting subsequent delivery and release.

[0041] like Figure 1 As shown in the embodiments of this application, the present invention provides an off-the-shelf total endovascular repair system for treating Stanford type A aortic dissection, including an ascending aortic assembly, a coronary artery assembly, and an aortic valve assembly.

[0042] The ascending mandible assembly is divided into the distal ascending mandible segment and the proximal sinus segment. The distal end is anchored to the ascending aorta anterior to the brachiocephalic trunk, and a bare stent can be used to enhance the anchoring force.

[0043] The main section metal support consists of multiple W-shaped nickel-titanium alloy metal wires connected end to end. The outer wall of the support is covered with a film, which can be ePTFE hot-pressed onto the outer wall of the metal support.

[0044] The ascending main segment has a diameter of 30-46 mm and a length of 50-60 mm. The proximal end naturally transitions into a "concave" sinus duct segment. Two inset branches with a diameter of 6-8 mm and a length of 15-20 mm are located at both ends of the covered segment before the concave portion, opening into the sinus duct segment.

[0045] The periphery of the sinus duct segment is a bare metal stent. The concave part of the sinus duct segment has a maximum diameter of 20-40 mm and a length of 10-20 mm. The inset branches of the ascending main segment open on both sides of the concave part.

[0046] There is a narrow space between the sinus segment and the aortic sinus wall. This narrow space communicates with the inlaid branches of the ascending aorta and the openings of the bilateral autologous coronary arteries. Therefore, after the ascending aortic graft is released, it will not block the coronary arteries, thus avoiding the risk of coronary ischemia.

[0047] Simultaneously, a large-mesh bare metal stent is added to the outside of the "recessed" aortic duct to support the collapsed intimal flap, ensuring the patency of the true lumen of the aortic sinus. The bare metal stent and the "recessed" area restrict the displacement of the guidewire and catheter, facilitating rapid superselection of both coronary arteries during the procedure. If the technology matures, the bare metal stent in the second-generation product can be designed to be absorbable, gradually degrading during the root remodeling process after graft implantation, which is beneficial for reducing left ventricular afterload in the long term.

[0048] The coronary artery assembly is a cone-shaped stent-type artificial blood vessel with one port having a uniform diameter of 8mm, overlapping with the embedded branch of the ascending main assembly, and the other port having a diameter of 3-5mm, extending into the left and right main coronary arteries. The length of the coronary artery assembly is 30-50mm.

[0049] The valve assembly is a self-expanding interventional valve, consisting of a positioning stent and a leaflet stent for leaflet attachment. Valvular regurgitation caused by aortic dissection has a different pathophysiology than aortic stenosis with regurgitation caused by degenerative changes or rheumatic heart disease. It is often accompanied by sinus dilation and annular enlargement. Therefore, currently available TAVI valves, whether bulb-expanding or self-expanding, are not suitable for valvular regurgitation caused by aortic dissection.

[0050] The bulb-expandable TAVI valve primarily anchors to the aortic annulus and relies on radial force. When dissection causes annular dilation or damage, the bulb-expandable valve cannot be firmly fixed to the significantly dilated annulus, relying only on a short left ventricular outflow tract, which is insufficient to guarantee secure anchoring. While the self-expanding TAVI valve adds the sinoductal commissure as an anchoring zone, it still faces the same problem when dissection involves both the sinoductal commissure and the annulus. With only a short and unstable left ventricular outflow tract remaining as an anchoring zone, it cannot anchor properly, increasing the risk of paravalvular leakage. Furthermore, the crown-like design of the aortic segment of the self-expanding valve makes it difficult to connect with ascending aortic stents. This invention addresses valvular insufficiency caused by dissection by designing a valve assembly consisting of a positioning stent and a valve stent. The valve is made from bovine / porcine pericardium and sewn onto a bare nickel-titanium alloy metal stent. The valve stent has a height of 15-23 mm and a diameter of 20-30 mm. The proximal diameter of the valve stent is slightly larger than the diameter of the proximal sinus segment of the ascending aortic graft (magnification greater than 20%), and after expansion, it connects with the stent through radial support. The distal end of the valve is anchored to a positioning stent and is fixed and restricted by the positioning stent.

[0051] The positioning stent consists of three petal-shaped bare stents, each with a long U-shaped stent at the junction of the petals. After the positioning stent is released, the three long U-shaped stents extend into the left ventricular outflow tract, working in conjunction with the valve assembly inflow tract anchoring zone to strengthen anchoring. The three corollas unfold in the sinus-valve annulus region, fixing and limiting the displacement of the valve stents.

[0052] After the positioning stent is opened, the position of the valve stent is adjusted, with the proximal end fixed in the positioning stent and the distal end connecting with the "recessed" part of the ascending aortic assembly, anchored by radial support force. Thus, the valve assembly is positioned and fixed by three anchoring sites (left ventricular outflow tract, annulus-sinus petals, and ascending aortic assembly), replacing the function of the original aortic valve.

[0053] First implementation method: A graft for treating aortic dissection involving the aortic root, causing or not causing aortic valve leaflet dysfunction, comprises: an ascending aortic component anchored to the ascending aorta and extending into the aortic sinus, providing a foundation for endovascular reconstruction of both coronary arteries. The ascending aortic component can be loaded into a 20-24F large sheath using existing TEVAR stent loading methods, and released after sheathing via the femoral artery access. A coronary component, via the brachial artery access, enters the inlaid branch of the ascending aortic component; after sheathing release, the proximal end overlaps with the inlaid branch, and the distal end enters the left / right main coronary artery to reconstruct coronary blood flow. Two coronary components are required for each procedure to reconstruct the left and right main coronary arteries; the coronary components are also loaded into a 6-8F sheath using existing covered stent loading methods, and released after sheathing. When the lesion does not involve the autologous aortic valve, graft placement is as described in the first embodiment. A valve component is not used if the lesion does not involve the aortic valve and the autologous valve is functional. If aortic valve insufficiency is present, the valve assembly is connected to the left ventricular outflow tract and the ascending aortic assembly via an apical approach. The proximal end of the valve assembly is fixed by a positioning stent, while the distal end is connected to the ascending aortic assembly via an enlarged orifice.

[0054] The loading method of the valve assembly is described in the second embodiment.

[0055] In the first embodiment, when the aortic dissection does not involve the aortic valve and the autologous valve is functioning normally, this embodiment requires the implantation of an ascending aortic assembly and a coronary artery assembly. Three pathways are established under X-ray guidance: left and right brachial-ascending aorta pathways, and femoral-ascending aorta pathways. A pigtail catheter is introduced into the aortic sinus via the left brachial pathway for intraoperative angiographic localization. The right brachial pathway is used to establish bilateral coronary blood supply. A super-stiff guidewire is inserted into the left ventricle via the femoral approach. Following the preoperative measurement plan, the machine head is rotated to a position that clearly displays the sinus-duct junction, left / right / non-coronary sinuses, and bilateral coronary arteries. First, the ascending aortic assembly is placed: this assembly is mounted in a pre-bent outer sheath, with figure-eight contrast rings sewn onto the outer sides of the two embedded branch openings.

[0056] When the figure-eight shape transforms into a figure-one, with its apex aligned with the junction of the sinus duct, the outer sheath of the ascending main component can be quickly withdrawn to the figure-one position. At this point, the bare stent in the sinus duct portion of the ascending main component and the "recessed covered portion" are released first. Angiography via the sinus marking catheter is then performed to reconfirm the position of the coronary artery ostium and the embedded branch. The graft is adjusted appropriately, and the ascending main component is quickly and completely released. At this point, the bare stent pushes the intimal flap against the arterial wall, achieving intraluminal "sinoplasty." Immediately via the brachial artery approach, the right coronary artery is reconstructed first (in most cases of dissection, the right coronary ostium is partially occluded due to intimal flap collapse).

[0057] The guidewire catheter, in conjunction with the right embedded branch of the ascending main component, a bare stent, and the coronary ostium, is superselectively advanced into the right coronary artery. The coronary artery assembly is then immediately advanced, with the proximal end overlapping with the embedded branch of the ascending main component, and the distal end entering the right coronary artery. The left coronary artery is reconstructed using the same method. Alternatively, a 0.014 guidewire can be pre-embedded in the embedded branch to accelerate coronary artery reconstruction.

[0058] In the second embodiment, This implementation method is used when the aortic dissection involves the aortic valve and the patient has autologous valve insufficiency. A valve assembly is required. The valve assembly can be placed via the apical approach. After completing the first implementation method, the pre-loaded valve assembly is placed via the apical approach.

[0059] Valve component loading method as follows Figure 2 Place the rinsed valve stent onto the valve loading rod of the delivery device, aligning the outflow end of the stent with the tip. Using the dividing pad as a boundary, position the stent near the tip of the tip. Pull the positioning stent towards the distal tip. Move the "corolla stent" and "long U-shaped stent" along the loading rod towards the inflow end. Use the valve depressor to completely compress the valve stent into the tip. At this point, the valve outflow end should face forward. Figure 2 As shown. Hook the long U-shaped bracket of the positioning bracket onto the three locking buttons of the buckle, pinch the "crown", push the outer sheath, and retract the positioning bracket into the outer sheath, as shown. Figure 2 As shown, the valve assembly has been loaded.

[0060] After establishing apical access, the delivery device is inserted into the left ventricle along with the guidewire, with the distal end of the guidewire in the descending aorta. Once angiography shows the compressed valve stent in place, the outer sheath is withdrawn, the positioning stent springs open, and the entire delivery device is pulled towards the left ventricle with moderate force, anchoring the long U-shaped stent in the left ventricular outflow tract, ensuring the petals are attached to the autologous valve sinus. The delivery device is finely adjusted to reposition the valve, and the tip is pushed forward, opening the valve. At this point, the valve outflow end is anchored in the "recess" of the ascending aorta assembly by radial support force, aligning with the positioning stent and the original valve, causing the valve stent to extend into the predetermined shape, pushing open the diseased valve and replacing the original valve to perform its function. The delivery device is withdrawn into the left ventricle, the tip and locking key are retracted into the delivery sheath, and the device is withdrawn from the left ventricle. The purse-string suture at the apex is tightened.

[0061] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application, and should all be included within the protection scope of this invention.

Claims

1. An off-the-shelf total endovascular repair system for treating Stanford type A aortic dissection, comprising a primary core and secondary supporting modules; characterized in that, The primary core component includes the ascending aortic assembly, the coronary artery assembly, and the aortic valve assembly; the secondary supporting modules include the delivery unit and auxiliary tools. The ascending main component includes an ascending main segment covered stent (14), an embedded branch (15), an "8" mark (16) at the junction of the ascending main part and the sinus duct part of the ascending main component, a recessed part (17) of the sinus duct part of the ascending main component, and a bare stent (18) of the sinus duct part of the ascending main component; the "8" mark (16) at the junction of the ascending main part and the sinus duct part of the ascending main component is located at the junction of the ascending main segment covered stent (14) of the ascending main component and the bare stent (18) of the sinus duct part of the ascending main component; the recessed part (17) of the sinus duct part of the ascending main component is located at the proximal end of the bare stent (18) of the sinus duct part of the ascending main component; and the embedded branch (15) of the ascending main component is connected to the ascending main segment covered stent (14) of the ascending main component. The coronary artery assembly includes a coronary artery assembly bridging portion (19) and a coronary artery assembly coronary portion (20); one end of the coronary artery assembly bridging portion (19) is connected and fixed to the embedded branch (15) of the ascending aorta assembly, and the other end extends into the left / right coronary artery to form a blood flow channel from the ascending aorta to the coronary vessels with the coronary artery assembly coronary portion (20); The aortic valve assembly includes a valve stent (12), a trilobite (2) of the valve stent, a positioning stent (13), an outflow tract anchoring area (1) of the valve assembly, and an inflow tract anchoring area (5) of the valve assembly; the trilobite (2) of the valve stent is embedded inside the valve stent (12), the positioning stent (13) includes a corolla stent (3) of the valve assembly positioning stent and a long U-shaped stent (4) of the valve assembly positioning stent, the outflow tract anchoring area (1) of the valve assembly is located at the distal end of the valve stent (12), and the inflow tract anchoring area (5) of the valve assembly is located at the proximal end of the valve stent (12); The delivery assembly includes a valve assembly delivery tip (6), a valve assembly loading rod (7), a dividing pad (8), a long U-shaped bracket lock (9), a delivery outer sheath (10), and a delivery push rod (11). The valve assembly delivery tip (6) is fixed to the front end of the delivery push rod (11), and the delivery outer sheath (10) is sleeved on the outside of the delivery push rod (11). The valve assembly loading rod (7) is adapted to the valve stent (12) and is used for loading and releasing control of the valve assembly. The dividing pad (8) is fixed to the loading rod (7) and is used to separate the valve stent (12) from the positioning bracket (13) when loading the valve assembly. The long U-shaped bracket lock is located at the end of the loading rod (7) and is used to hook the long U-shaped bracket (4) when loading the valve assembly. The auxiliary tool is a valve presser (21), which is compatible with the leaflet (2) of the valve assembly and the valve stent (12), and is used for positioning and pressing the leaflet (2) during the assembly of the valve assembly.

2. The system of claim 1, wherein the system is a pre-loaded full endovascular repair system for treating a Stanford Type A dissection. The coronary artery assembly bridging part (19) is made of polytetrafluoroethylene coated flexible material, and the diameter of the coronary artery part (20) of the coronary artery assembly is 4-6mm.

3. The system of claim 1, wherein the system is a pre-loaded full endovascular repair system for treating a Stanford Type A dissection. The valve stent (12) is a self-expanding nickel-titanium alloy stent. The lobule (2) of the valve component valve stent is made of bovine pericardium material, and the edge of the lobule (2) of the valve component valve stent is provided with reinforcing sutures to enhance the connection stability between the lobule (2) and the valve stent (12).

4. The system of claim 1, wherein the system is a pre-loaded full endovascular repair system for treating a Stanford Type A dissection. The surfaces of the valve assembly outflow tract anchoring area (1) and the valve assembly inflow tract anchoring area (5) are both provided with a roughened polyether ether ketone coating. The surface roughness Ra of the roughened polyether ether ketone coating is 1.5-3.0 μm, which is used to enhance the friction between the anchoring area and the blood vessel wall.

5. The system of claim 1, wherein the system is a pre-loaded full endovascular repair system for treating a Stanford Type A dissection. The valve assembly delivery tip (6) has a built-in tungsten alloy imaging marker inside, and the figure-eight marker (16) at the junction of the ascending main part and the sinus duct part of the ascending main assembly is a tantalum wire braided structure, which is used for imaging positioning during the operation.

6. The system of claim 1, wherein the system is a pre-loaded full endovascular repair system for treating a Stanford Type A dissection. The outer sheath (10) of the delivery device is made of nylon-12 material and the wall thickness of the outer sheath (10) is 0.15-0.2mm; the delivery push rod (11) is a stainless steel hollow tube and the inner diameter of the delivery push rod (11) is adapted to the outer diameter of the guide wire for interventional surgery, and a guide wire channel for the guide wire to pass through is formed inside.

7. The system of claim 1, wherein the system is a pre-loaded full endovascular repair system for treating a Stanford Type A dissection. The valve stent and positioning stent dividing pad (8) is made of silicone rubber, and the thickness of the valve stent and positioning stent dividing pad (8) is 0.3-0.5mm. The inner diameter of the valve stent and positioning stent dividing pad (8) is adapted to the inner diameter of the valve stent (12).

8. The system of claim 1, wherein the system is a pre-loaded full endovascular repair system for treating a Stanford Type A dissection. The corolla support (3) of the valve assembly positioning stent is located at the distal end of the positioning stent (13) and has a petal-like unfolding structure; the long U-shaped support (4) of the valve assembly positioning stent is located at the proximal end of the positioning stent (13), and its U-shaped structure extends to the left ventricular outflow tract to assist the valve assembly in anchoring the inflow tract anchoring area.

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