Covered stent system

Abstract

The invention provides a covered stent system, which comprises: a) a covered stent comprising: i) a positioning assembly; ii) a first branch blood vessel windowing assembly, wherein the first branch blood vessel windowing assembly comprises a first sealing area and a first adjusting area; the first sealing area 111 comprises a third opening; the first adjusting area comprises a first opening, a second opening, a first reinforcing structure and a second reinforcing structure; and b) a first branch covered stent, wherein the first branch covered stent is used for being released in the first branch blood vessel windowing assembly.

Description

Technical Field

[0001] The invention relates to a covered stent with fenestrations, which is used for treating vascular diseases involving trunk and branch vessels. Background Art

[0002] The present invention is suitable for treating diseases in which the lesions involve the main trunk and branch vessels. For the convenience of description below, aortic dissection in which the lesions involve the aortic arch and branches above the aorta is taken as an example.

[0003] like Figure 1A and Figure 1B As shown, the aortic arch area is composed of the ascending aorta 31, the innominate artery 32, the left common carotid artery 33, the left subclavian artery 34 and the descending aorta 35. Aortic dissection refers to a disease in which the middle layer of the blood vessel is destroyed due to bleeding in the aortic vessel wall, resulting in the separation of the vessel wall and the subsequent formation of a true lumen 36 and a false lumen 37 that are interconnected or not interconnected. In most cases, aortic dissection starts with an intimal tear, and blood enters the middle layer through the intimal tear 38, eventually leading to aortic rupture or re-entering the true lumen through a second intimal tear. According to the site of the dissection, aortic dissection is divided into Stanford A type dissection (dissection involves the ascending aorta), Stanford B type dissection (dissection only involves the descending aorta) and non-A and non-B type dissection (dissection involves the aortic arch but not the ascending aorta).

[0004] Among the new cases of aortic dissection each year, type A dissection accounts for about 60%, and non-A and non-B type dissection accounts for about 10%.

[0005] For type A dissection and non-type A non-B dissection, since the lesions involve the three branch vessels of the ascending aorta and the aortic arch, and the structural relationship between the main trunk and the branch vessels in each patient, including the location of the branch vessel opening, the distance between the branch vessels, and the direction of the branch vessel opening are different, there is no standardized interventional stent implant product suitable for lesions involving equal to or more than two branch vessels and suitable for the above differences. Therefore, currently, the only conventional method is open-chest surgery under extracorporeal circulation. However, surgical surgery has the following problems: 1) The operation is complicated, time-consuming, and difficult to popularize: Figure 2As shown, the operation needs to be performed under extracorporeal circulation. The doctor frees the entire aortic arch blood vessels and removes them, replaces them with artificial blood vessels 4, and completes end-to-end sutures between artificial blood vessels and autologous blood vessels at least five locations (ascending aorta 41, innominate artery 42, left common carotid artery 43, left subclavian artery 44, descending aorta 45). The operation time is about 6-10 hours, the average extracorporeal circulation time is 2-3 hours, the average aortic clamping time is 1.5-2 hours, and the average deep hypothermic circulatory arrest time is 20-30 minutes; in short, the operation is complicated and time-consuming, the doctor has a long learning curve, and it is not easy to promote.

[0006] 2) Prolonged deep hypothermic circulatory arrest can easily lead to ischemia of organs and lower limbs: The average duration of deep hypothermic circulatory arrest is 20-30 minutes. Circulatory arrest can easily cause ischemic and hypoxic damage to various organs, and deep hypothermia can easily lead to pathophysiological changes in various organs.

[0007] 3) The above-mentioned parts are difficult to suturing end to end, the anastomosis is prone to bleeding, and there is a lot of bleeding at the free original arch serosa junction; all of the above lead to difficulty in hemostasis.

[0008] 4) High surgical risk: The surgical mortality rate abroad is 10%-33%. [3] The surgical mortality rate in China is 3.1%~15.5%, the incidence of acute respiratory insufficiency is 5%~15%, the incidence of neurological complications is 4%~30%, the incidence of renal failure is 5%~12%, and the incidence of postoperative hospital infection is about 12%. [4] The onset and progression of lesions are very fast (the mortality rate of type A dissection within 48 hours after onset is 40% to 50%), and the patient's transfer time is long. Therefore, many patients die before they receive treatment.

[0009] As the number of patients with hypertension increases year by year around the world, the prevalence of the above diseases increases year by year. Due to the above characteristics, many patients cannot get timely treatment locally and lose their lives, making this disease a pain point that has troubled clinicians for many years. For more than ten years, doctors from all over the world have repeatedly tried to use interventional endovascular repair for treatment to reduce the above clinical difficulties. There are mainly the following methods: 1) In situ fenestration technology: The straight-cylindrical thoracic aortic stent-graft is implanted into the aortic arch area via catheter. The membrane of the thoracic aortic stent-graft is ruptured in situ at the corresponding positions of the three branch blood vessels on the aortic arch during the operation, and the ruptured membrane is dilated by balloon. After the ruptured membrane is dilated, the corresponding branch stent-grafts are implanted one by one via catheter. This technology has the following problems: a. After implantation of the thoracic aortic stent-graft and before rupture of the membrane and opening of the window, the corresponding branch vessel opening is isolated by the thoracic aortic stent-graft and is in an ischemic state. If the ischemic state lasts too long, it will cause extremely serious brain complications; b. The rupture of the membrane and opening of the window on the thoracic aortic membrane are physical tears. After implantation of the branch stent-graft, the membrane rupture is mostly not tightly fitted to the ruptured opening, resulting in a high incidence of endoleak (blood flows out from the gap between the ruptured opening on the thoracic aortic membrane and the branch stent-graft), and the false lumen continues to expand, and patients often need secondary surgical intervention; c. The surgical operation is complicated, the operation time is long, and it is not easy to promote; d. Most operations such as rupture of the membrane and implantation of the branch stent-graft are through the arteries on the neck or right arm (such as the brachial artery) and the branch vessels above the arch as the access route (called the upper access route in the interventional field). The instruments go back and forth inside these branch vessels, which can easily cause the plaques (most of them have plaques) in these branch vessels to fall off, resulting in cerebral infarction during the operation, or cause damage to the intima of the branch vessels to form plaques and eventually fall off, resulting in cerebral infarction.

[0010] 2) Embedded tunnel and module bridging technology: The thoracic aortic stent graft with three inner tunnels is implanted into the aortic arch area via a catheter, and these three inner tunnels are used as the interface for bridging the thoracic aortic stent graft and the branch stent graft. Among them, the inner tunnels corresponding to the innominate artery and the left common carotid artery extend from the roots of their respective branch vessels to the ascending aorta, and the inner tunnel corresponding to the left subclavian artery extends from the root of the left subclavian artery to the descending aorta; the catheter is implanted one by one through the upper access to the branch stent graft corresponding to the innominate artery and the left common carotid artery, and the branch stent graft corresponding to the left subclavian artery is implanted through the femoral artery access (called the lower access in the interventional field). This type of technology also has the following problems: the branch stent grafts of the innominate artery and the left common carotid artery are implanted through the upper access, which is not only long and difficult to operate, but many operations are performed in the arch branch vessels, which can easily cause the plaque in the original branch vessels to fall off, resulting in cerebral infarction during the operation, or cause the intima of the branch vessels to be damaged and plaques to form and eventually fall off, resulting in cerebral infarction.

[0011] 3) Hybrid surgery: Hybrid surgery is roughly divided into two steps: first, surgical bypass surgery is performed between the innominate artery and the left common carotid artery and the left subclavian artery in the neck using artificial blood vessels; then, a branched interventional covered stent with an innominate artery stent is implanted into the innominate artery in the aortic arch area through the lower passage through a catheter. The blood supply between the branch vessels in this area is established. This technology needs to be performed in two stages. The operation is complicated and the patient has to wait for a long time. Surgical bypass surgery in the neck may cause corresponding complications, such as bleeding and infection. In addition, this reconstruction method greatly changes the blood flow pattern of the original supra-arch branches, and the bypassed blood vessels may be narrowed or blocked.

[0012] The above methods have the disadvantages of long operation time, complicated operation, various complications, no standardization of instruments and surgical methods, and cannot be promoted in most hospitals. Summary of the invention

[0013] The present invention provides a stent graft system. In one embodiment, the stent graft system includes a) a stent graft, including: i) a positioning assembly; ii) a first branch vessel window assembly, the first branch vessel window assembly includes a first sealing area and a first adjustment area; the first sealing area includes a third opening; the first adjustment area includes a first opening, a second opening, a first reinforcement structure, and a second reinforcement structure; b) a first branch stent graft, the first branch stent graft is used to be released in the first branch vessel window assembly; the first reinforcement structure maintains the first opening, and the second reinforcement structure maintains the second opening; the first adjustment area is located between the first reinforcement structure and the second reinforcement structure; the first adjustment area enables the second opening to move relative to the positioning assembly; the first sealing area extends from the second reinforcement structure to the third opening, so that the first branch stent graft is released and deployed to form a planar sealing connection with the first sealing area; and the first branch stent graft includes a first connection anchoring segment, the diameter of the first connection anchoring segment after release is larger than the first opening of the first adjustment area, so that the first connection anchoring segment is retained at the proximal end of the first opening of the first adjustment area.

[0014] The present invention further provides a method for implanting a stent graft into a blood vessel, wherein the blood vessel includes a main trunk, a positioning branch vessel, and a first branch vessel. In one embodiment, the method includes the following steps: a) providing a stent graft system according to the present invention; b) delivering the stent graft into the main trunk of the blood vessel; c) aligning the positioning assembly with the positioning branch vessel; d) releasing the stent graft so that the stent graft fits the inner wall of the main trunk and the positioning assembly is aligned with the root of the positioning branch vessel; e) delivering the first branch stent graft into the first branch vessel through the first branch vessel window assembly; f) releasing the first branch stent graft so that the second opening is aligned with the root of the first branch vessel, so that the first sealing area is connected to the first branch stent graft in a planar sealing manner, and the first connection anchoring section is retained at the proximal end of the first opening of the first adjustment area. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1A Schematic diagram showing the normal aorta. Figure 1B Schematic diagram showing aortic dissection.

[0016] Figure 2 Demonstrating five places in the surgical procedure where artificial blood vessels were sutured end-to-end with autologous blood vessels.

[0017] Figure 3 is a front view of a stent graft with a fenestration assembly.

[0018] Figure 4 It is a front view of the window opening assembly.

[0019] Figure 5 It is a top view of the window opening assembly.

[0020] Figure 6 It is a front view of the window opening assembly.

[0021] Figure 7 It is a cross-sectional view of the first reinforcing structure (the second reinforcing structure) and the first developing structure (the second developing structure).

[0022] Figure 8 Shown is the inserted fenestrated stent-graft aligned with the root of the left common carotid artery and the middle fenestrated component (the fenestrated stent-graft is not released and before deployment).

[0023] Fig. 9 Schematic diagram showing the fenestrated stent graft after release and deployment.

[0024] Fig.10 Schematic diagram showing the delivery of a branch stent graft loaded in a delivery system to the left common carotid artery.

[0025] Fig.11Schematic diagram showing the left common carotid artery branch covered stent after release and deployment.

[0026] Fig.12 A schematic diagram showing the delivery of a branch covered stent loaded in a delivery system to the innominate artery. At this time, the second opening is still misaligned with the root of the branch blood vessel.

[0027] Fig.13A Schematic diagram showing that the second opening is misaligned with the root of the branch vessel.

[0028] Fig. 13B A schematic diagram showing the alignment of the second opening with the root of the branch vessel.

[0029] Fig.14 A schematic diagram showing the innominate artery branch covered stent after release and deployment. At this point, the second opening is aligned with the root of the branch blood vessel.

[0030] Fig.15 A schematic diagram showing the left subclavian artery branch stent graft after release and deployment. At this point, the second opening is aligned with the root of the branch blood vessel.

[0031] Fig.16 Showing clinical CT angiography before and after surgery for clinical trial case 001-005.

[0032] Fig.17 Showing clinical CT angiography before and after surgery in clinical trial case 006-010.

[0033] Fig.18 Displays the comparison of velocity contours and streamlines between the model with sealing area and the model without sealing area in finite element analysis.

[0034] Fig.19 Comparison of velocity contours between the model with and without sealing areas in finite element analysis. DETAILED DESCRIPTION

[0035] Diseases involving trunk and branch vessels are currently the most dangerous cardiovascular diseases that seriously endanger the life safety of patients. They need to be sent to a large heart center for emergency treatment and undergo extremely invasive surgical operations. Patients often lose their lives due to the lack of timely treatment. At the same time, even if timely treatment is obtained, the mortality rate of the operation itself is as high as 10%-33%, and various postoperative complications are as high as 4%-30%. This is a pain point that has long plagued the clinical treatment of such patients. The main beneficial effects of the present invention are as follows: 1) It can replace most of the current open-view surgeries that require surgical thoracotomy or laparotomy and deep hypothermic circulatory arrest under extracorporeal circulation. It only requires catheter intervention and implantation to treat related diseases, greatly reducing trauma, the high mortality rate and complications caused by surgical operations, and creating a new treatment method for diseases involving branch vessels; 2) The above-mentioned many innovative inventions can not only all be implanted through the lower limb artery intervention, but also are simple to operate, easy to learn, and easy to promote to most intermediate hospitals, changing the current situation where such patients need to be sent to large hospitals hundreds of kilometers away for emergency surgery, so that many patients can receive timely and rapid treatment in local hospitals, greatly improving the survival rate of such patients; 3) The cost of using catheter interventional methods and instruments to treat vascular diseases involving branch vessels is much lower than that of surgical treatment and has great clinical and social significance.

[0036] For the treatment of diseases involving main and branch vessels, the present invention provides a covered stent with a window assembly, which can be combined with a branch covered stent to reconstruct diseased blood vessels; for patients with type A and non-type A and non-B dissections (including aneurysms, intramural hematomas, and multiple penetrating ulcers in this area) as mentioned above, the diseased aorta can be reconstructed by using the covered stent provided by the present invention.

[0037] The present invention provides a stent graft system. In one embodiment, the stent graft system includes a) a stent graft, including: i) a positioning assembly; ii) a first branch vessel window assembly 11, the first branch vessel window assembly 11 includes a first sealing area 111, a first adjustment area 112; the first sealing area 111 includes a third opening 1112; the first adjustment area includes a first opening 1121, a second opening 1122, a third opening 1112, a first reinforcement structure 113, and a second reinforcement structure 114; b) a first branch stent graft, the first branch stent graft is used to be released in the first branch vessel window assembly 11; the first reinforcement structure 113 maintains the first opening 1121 and the second reinforcement structure 114 The first adjustment area 112 is located between the first reinforcement structure 113 and the second reinforcement structure 114; the first adjustment area 112 enables the second opening 1122 to move relative to the positioning assembly; the first sealing area 111 extends from the second reinforcement structure 114 to the third opening 1112, so that the first branch coated stent forms a planar sealing connection with the first sealing area 111 after release and deployment; and the first branch coated stent includes a first connection anchoring segment, the diameter of the first connection anchoring segment after release is larger than the first opening 1121 of the first adjustment area, so that the first connection anchoring segment is retained at the proximal end of the first opening 1121 of the first adjustment area.

[0038] In one embodiment, the sealing area 111 extends from the second reinforcement structure to the third opening 1112 , and the extension is from the second reinforcement structure toward the adjustment area 112 .

[0039] In one embodiment, the sealing area 111 extends from the second reinforcement structure to the third opening 1112 , and the extension is extending from the second reinforcement structure to another direction of the adjustment area 112 .

[0040] In one embodiment, the sealing area 111 extends from the second reinforcement structure to the third opening 1112 , and the extension is from the second reinforcement structure to the adjustment area 112 and to another direction simultaneously.

[0041] In one embodiment, the first reinforcing structure 113 includes a first developing structure 115 ; the second reinforcing structure 114 includes a second developing structure 116 ; or the first adjusting area 112 includes a third developing structure 117 .

[0042] In one embodiment, the positioning assembly includes a positioning sealing area 111 and a positioning adjustment area 112; the positioning sealing area 111 includes a positioning third opening 1112; the positioning adjustment area 112 includes a positioning first opening 1121, a positioning second opening 1122, a positioning first reinforcement structure 113, and a positioning second reinforcement structure 114.

[0043] In one embodiment, the stent graft further includes a positioning branch stent graft, and the positioning branch stent graft is used for implanting the positioning component.

[0044] In one embodiment, the first connecting anchoring section includes a flange bracket and a flange coating.

[0045] In one embodiment, the relative sizes of the first opening 1121, the second opening 1122 and the third opening 1112 are selected from one or more of the following: a) the first opening 1121 is larger than the second opening 1122; b) the second opening 1122 is larger than the third opening 1112; c) the first opening 1121 is equal to the second opening 1122; d) the second opening 1122 is equal to the third opening 1112.

[0046] In one embodiment, the first adjustment area 112 or the first sealing area 111 is a flexible cylindrical or truncated cone-shaped film.

[0047] In one embodiment, the first opening 1121 , the second opening 1122 , or the third opening 1112 is circular or quasi-circular in shape.

[0048] In one embodiment, the first reinforcement structure 113 or the second reinforcement structure 114 is made of a superelastic material (metal, alloy, polymer, etc.).

[0049] In one embodiment, the connection between the first sealing area 111 and the first branch stent graft is a planar connection.

[0050] In one embodiment, the coated stent system further includes a second branch vessel window assembly and a second branch coated stent; the second branch vessel window assembly includes a second sealing area 111 and a second adjustment area 112; the second sealing area 111 includes a third opening 1112; the second adjustment area includes a first opening 1121, a second opening 1122, a first reinforcement structure 113, and a second reinforcement structure 114; the second branch coated stent includes a second connecting anchoring segment, and the diameter of the second connecting anchoring segment after release is larger than the first opening 1121 of the second adjustment area, so that the second connecting anchoring segment is retained at the proximal end of the first opening 1121 of the second adjustment area; the positioning assembly is used to be implanted in the left common carotid artery; the first branch vessel window assembly is used to be implanted in the innominate artery; the second branch vessel window assembly is used to be implanted in the left subclavian artery.

[0051] The present invention further provides a method for implanting a stent graft into a blood vessel, wherein the blood vessel includes a main trunk, a positioning branch vessel, and a first branch vessel. In one embodiment, the method includes the following steps: a) providing a stent graft system according to the present invention; b) delivering the stent graft into the main trunk of the blood vessel; c) aligning the positioning assembly with the positioning branch vessel; d) releasing the stent graft so that the stent graft fits the inner wall of the main trunk and the positioning assembly is aligned with the root of the positioning branch vessel; e) delivering the first branch stent graft into the first branch vessel through the first branch vessel window assembly 11; f) releasing the first branch stent graft so that the second opening is aligned with the root of the first branch vessel, so that the first sealing area 111 is connected to the first branch stent graft in a planar sealing manner, and the first connection anchoring section is retained at the proximal end of the first opening 1121 of the first adjustment area.

[0052] In one embodiment, the blood vessel is the aortic arch, and the located branch vessel or the first branch vessel is selected from one of the left common carotid artery, the innominate artery and the left subclavian artery.

[0053] In one embodiment, the blood vessel is the abdominal aorta, and the located branch vessel or the first branch vessel is selected from one of the celiac trunk, the left renal artery, the right renal artery, and the superior mesenteric artery.

[0054] In one embodiment, the blood vessels are the aortic root and the ascending aorta, and the located branch vessel or the first branch vessel is selected from one of the left coronary artery and the right coronary artery.

[0055] In one embodiment, the blood vessel is any artery or vein with two or more branches, and the located branch vessel or the first branch vessel is selected from one of the branches of the blood vessel.

[0056] In one embodiment, the step (d) further includes: i) delivering a positioning branch coated stent into the positioning blood vessel through the positioning component; the positioning component includes a positioning sealing area 111 and a positioning adjustment area 112; the positioning sealing area 111 includes a positioning third opening 1112; the positioning adjustment area 112 includes a positioning first opening 1121, a positioning second opening 1122, a positioning first reinforcement structure 113, and a positioning second reinforcement structure 114; the positioning branch coated stent includes a positioning connection anchoring segment, and the diameter of the positioning connection anchoring segment after release is larger than the positioning first opening 1121, so that the positioning connection anchoring segment is retained at the proximal end of the first opening 1121 of the positioning adjustment area; ii) releasing the positioning branch coated stent so that the positioning second opening is aligned with the root of the positioning branch blood vessel, the positioning sealing area 111 and the positioning branch coated stent are connected in a planar sealing manner, and the first connection anchoring segment of the positioning branch coated stent is retained at the proximal end of the first opening 1121 of the positioning adjustment area.

[0057] The technical problems mainly solved by the present invention are: 1) The sealing area 111 of the fenestration assembly of the present invention is a cylindrical or truncated cone-shaped flexible membrane structure, which can ensure the sealing between the fenestration assembly and the branch stent graft, effectively prevent internal leakage, and solve the problem of internal leakage that may occur after the branch stent graft is implanted in various fenestration design principles; 2) The adjustment area 112 of the fenestration assembly of the present invention allows the position and angle of the second opening 1122 of the fenestration assembly to be movable and adjustable within a certain range to accommodate the anatomical differences existing in most trunk and branch blood vessels; 3) The structure of the fenestration assembly of the present invention does not limit the entry position of the branch stent graft system, and the branch stent graft can be implanted entirely through the femoral artery (lower access), avoiding the problem of postoperative cerebral complications caused by the detachment of plaques on the inner wall of the branch blood vessels caused by the embedded tunnel, modular bridging and other technologies when entering from the upper access, thereby shortening the operation time, facilitating the doctor's operation and promoting the promotion of the operation; 4) The fenestration of the present invention has a reinforced structure. After the covered stent is implanted in the blood vessel, it can isolate the blood vessel wall and the lesion site (false lumen, hematoma, etc.). Even when the blood vessel is compressed, the shape of the fenestration can be maintained, and the blood flow in the branch blood vessels can be maintained, thereby solving the problem of brain blood supply that may occur when other technologies only have a concave structure. At the same time, it facilitates the superselection of the guide wire during the operation (superselection refers to the catheter or guide wire selectively entering the target branch blood vessel).

[0058] 5) The fenestration assembly of the present invention has a developing structure, which can clearly display the position of the fenestration assembly under X-rays during the transportation process and the superselection process, thereby facilitating the intraoperative positioning of the coated stent, the superselection of the guide wire, and the intraoperative positioning of the branch coated stent.

[0059] The above features of the present invention are suitable for the repair and reconstruction of most trunk and branch blood vessels with anatomical differences (including dissecting aneurysms, true aneurysms, intramural hematomas, and multiple penetrating ulcers), such as the aortic arch and the three branch blood vessels above the arch as examples, as well as between the abdominal aorta and the left and right renal arteries, the superior mesenteric artery, and the celiac artery.

[0060] In one embodiment of the present invention, the cooperation between different components in the stent graft system can effectively prevent the problem of internal leakage that may occur after the implantation of the branch stent graft. In one embodiment, the diameter of the connecting anchoring section of the branch stent graft after release is larger than the first opening 1121 of the adjustment zone and is anchored at the proximal end of 1121, which is used as the main means of fixing the branch stent graft. The connecting anchoring section of the branch stent graft bears most of the force for fixing the branch stent graft, which can prevent the branch stent graft from detaching from the window assembly, thereby preventing the occurrence of type III internal leakage. When the branch vessel structure is different and the window assembly is misaligned, the first reinforcement structure 113 and the second reinforcement structure 114 can maintain the shape of the first opening 1121 and the second opening 1122, which is convenient for the superselection of the guide wire; at the same time, the second opening 1122 of the adjustment zone can automatically adjust its position when the branch stent graft is released, so that the second opening 1122 is automatically aligned with the root of the branch vessel, thereby correcting the misalignment and preventing the branch stent graft from kinking. After the branch stent graft is released and deployed, the sealing area 111 is a cylindrical or truncated cone-shaped flexible membrane structure, and a surface-to-surface seal is formed between the flexible membrane structure and the branch stent graft, thereby effectively preventing internal leakage.

[0061] The present invention is a stent graft with a window assembly for treating vascular diseases involving trunk and branch vessels. The device of the present invention is a stent graft with a window assembly, which comprises a window assembly 11, a columnar coating 12, and a stent ring assembly 13 (such as Figure 3 The window assembly 11 is composed of a sealing area 111, an adjustment area 112, a first opening 1121, a second opening 1122, a third opening 1112, a first reinforcement structure 113, a second reinforcement structure 114, a first developing structure 115, a second developing structure 116, and a third developing structure 117 (as shown). Figure 4 , Figure 5 Wherein, the third developing structure 117 is an optional component.

[0062] The covered stent 1 with a fenestration assembly is used to treat vascular diseases involving trunk and branch vessels. It is an assembly composed of multiple components combined through a certain process, and it includes at least one fenestration assembly 11.

[0063] The window assembly 11 is a connection structure between the stent graft with a window 1 and the branch stent graft, and is an assembly formed by combining multiple components through a certain process.

[0064] The columnar coating 12 is a layer of flexible cylindrical or truncated cone-shaped film attached to the stent ring 13 by suturing or hot melting, and its material is a biocompatible material.

[0065] The support ring 13 is a wavy or grid-shaped metal wire frame.

[0066] The sealing area 111 is a flexible cylindrical or truncated cone-shaped film that is attached to the second opening 1122 of the adjustment area 112 by suturing or hot melting, and extends upward. The material of the film is a biocompatible material. Optionally, the sealing area 111 extends upward and downward from the second opening 1122 at the same time. Figure 6 shown.

[0067] The adjustment area 112 is a flexible cylindrical or truncated cone-shaped film attached to the columnar covering 12 by suturing or hot melting, with a first opening 1121 and a second opening 1122 at both ends thereof, and is made of a biocompatible material.

[0068] The first opening 1121 is an opening of the adjustment region 112 on a side close to the columnar film 12 , and has a circular or quasi-circular shape.

[0069] The second opening 1122 is an opening on the side of the adjustment region 112 away from the columnar film 12 , and has a circular or quasi-circular shape, and a diameter or circumference smaller than that of the first opening 1121 .

[0070] The third opening 1112 is an opening on the side of the sealing area 111 away from the adjustment area 112 , and has a circular or circular-like shape, and a diameter or circumference less than or equal to the diameter or circumference of the second opening 1122 .

[0071] The first reinforcing structure 113 is a ring-shaped metal attached to the first opening 1121 by suturing or hot melting. The material thereof has superelasticity, such as nickel-titanium alloy, and has a certain degree of development effect.

[0072] The second reinforcement structure 114 is a ring-shaped metal attached to the second opening 1122 by suturing or hot melting. The material thereof has superelasticity, such as nickel-titanium alloy, and has a certain degree of development effect.

[0073] The first developing structure 115 is a spiral metal attached to the first reinforcing structure 113 by winding, and its material has a good developing effect under X-ray, such as platinum alloy and gold. Optionally, the first developing structure 115 is located at the center of the cross section of the first reinforcing structure 113, such as Figure 7 shown.

[0074] The second developing structure 116 is a spiral metal attached to the second reinforcing structure 114 by winding, and its material has a good developing effect under X-ray, such as platinum alloy and gold. Optionally, the second developing structure 116 is located at the center of the cross section of the second reinforcing structure 114, such as Figure 7 shown.

[0075] The third developing structure 117 is a ring or disc-shaped metal attached to the adjustment area 112 by sewing or hot melting, and its material has a good developing effect under X-ray, such as platinum alloy and gold.

[0076] The functions of each component in this embodiment are described as follows: The covered stent 1 with a fenestration assembly is used to treat vascular diseases involving branch vessels, reconstruct the branch vessels while reconstructing the main vessels, and maintain the patency of the branch vessels.

[0077] The fenestration assembly 11, as a structure connected to the branch stent graft, can be combined with the branch stent graft to adapt to different vascular anatomical structures when the columnar coating 12 and the stent ring 13 are fixed in the main blood vessel.

[0078] The columnar coating 12 ensures that blood does not extravasate to the outside of the coated stent, and can play a role in plugging the rupture of the blood vessel intima or plugging the aneurysm cavity together with the stent ring 13.

[0079] The stent ring 13 provides radial support force to firmly support the columnar coating 12 in the main blood vessel and supports the function of expanding the true lumen of the blood vessel and shrinking the false lumen.

[0080] The sealing area 111 can ensure the sealing between the branch coating stent and the window assembly 11 and reduce internal leakage.

[0081] The adjustment area 112 enables the second opening 1122 to move and rotate within a certain range to adapt to different branch blood vessel anatomical structures.

[0082] The first opening 1121 , through which blood flows into the regulating area 112 .

[0083] The second opening 1122 is used for blood to flow into the sealing area 111 .

[0084] The third opening 1112 is used for blood to flow out of the sealing area 111 .

[0085] The first reinforcing structure 113 maintains the shape of the first opening 1121, keeps the blood flow of the branch blood vessels smooth during and after the operation, and facilitates superselection during the operation.

[0086] The second reinforcing structure 114 maintains the shape of the second opening 1122, keeps the blood flow of the branch blood vessels smooth during and after the operation, and facilitates superselection during the operation.

[0087] The first developing structure 115 makes the shape of the first opening 1121 more obvious under intraoperative X-ray, thereby facilitating intraoperative positioning of the stent graft with a fenestration assembly 1, superselection of branches, and positioning of branch stent grafts.

[0088] The second developing structure 116 makes the shape of the second opening 1122 more obvious under intraoperative X-ray, thereby facilitating the intraoperative positioning of the stent graft with a fenestration assembly 1, the superselection of branches, and the positioning of the branch stent graft.

[0089] The third developing structure 117 makes the position of the fenestration assembly 11 more obvious under intraoperative X-ray, thereby facilitating the intraoperative positioning of the stent graft 1 with the fenestration assembly, the superselection of branches, and the positioning of the branch stent graft.

[0090] Description of surgical steps: In the present invention, the surgery for treating vascular diseases involving the main and branch vessels can be simplified into the following five steps. Here, for the convenience of explanation, the aortic arch area is selected as the area to be reconstructed: i. Such as Figure 8 As shown, the covered stent 1 with fenestrations is loaded in the conveying system, and the covered stent 1 with fenestrations has three fenestration components 11, which correspond to the innominate artery, the left common carotid artery and the left subclavian artery from left to right. The conveying system is conveyed to the designated position by aligning the root of the left common carotid artery and the developing structure (the first developing structure 115, the second developing structure 116 or the third developing structure 117) in the middle fenestration component 11.

[0091] ii. Fig. 9 As shown, the covered stent 1 with fenestrations is released into the aorta. At this time, the covered stent 1 with fenestrations adheres to the inner wall of the aorta, and the middle fenestration component 11 is aligned with the root of the left common carotid vessel.

[0092] iii. Fig.10 As shown, the branch coated stent 2 is loaded in the conveying system, and the conveying system is delivered to the designated position by aligning the developing structure (first developing structure 115) in the middle window assembly 11 with the developing structure on the branch coated stent (the first stent near one end of the heart).

[0093] iv. Fig.11 As shown, the branch stent graft 2 of the left common carotid artery is released. At this time, the end of the branch stent graft close to the heart is in contact with the sealing area 111 of the window assembly 11 of the stent graft with a window 1, and the end away from the heart is in contact with the inner wall of the branch blood vessel.

[0094] v. as Fig.12 As shown, the branch stent graft is loaded in the delivery system, and the delivery system is delivered to the designated position by aligning the imaging structure (first imaging structure 115) in the leftmost window assembly 11 in the figure with the imaging structure on the branch stent graft (the first stent near one end of the heart). Fig.13A and Fig. 13B As shown, when the second opening 1122 in the window assembly 11 on the far left in the figure is misaligned with the root 321 of the innominate artery, since the adjustment area 112 in the window assembly 11 allows the second opening 1122 to move and rotate within a certain range, when operating the guidewire superselection, pushing the branch coated stent system and releasing the branch coated stent, the second opening 1122 can adjust the position and angle to align with the root 321 of the innominate artery.

[0095] vi. Fig.14 As shown, the branch stent graft of the innominate artery is released, at which point the end of the branch stent graft close to the heart fits with the sealing area 111 of the fenestration assembly 11 of the stent graft with fenestration 1, and the end away from the heart fits with the inner wall of the branch blood vessel.

[0096] vii. Fig.15 As shown, steps v and vi are repeated to implant the left subclavian artery branch covered stent to complete vascular reconstruction in the aortic arch area.

[0097] For endovascular treatment of vascular diseases involving trunk and branch vessels, in situ fenestration technology, embedded tunnel, modular bridging technology, etc., the biggest problems are differences in the anatomical structure of branch vessels, internal leakage, branch covered stents need to be implanted from the distal end of the branch, complex operations, and long operation time. To address the above problems, this case has the following innovations: 1) The sealing area 111 of the window assembly 11 can ensure the sealing between the window assembly 11 and the branch membrane stent, and effectively prevent internal leakage. The sealing area 111 is a surface leakproof, and its leakproof effect is much better than that of a linear leakproof. In one embodiment, the sealing area 111 is a cylindrical or truncated cone flexible membrane structure.

[0098] 2) The opening position and angle of the window assembly 11 of the present invention can be adjusted within a certain range, which can adapt to the anatomical differences of most branch blood vessels due to individual differences. In addition, the specifications of the stent graft 1 with a window assembly can be greatly reduced, thereby reducing the difficulty of its design and production and reducing the inventory. In one embodiment, the adjustment area 112 of the window assembly 11 can adjust the position and angle of the second opening 1122 within a certain range, which can adapt to the anatomical differences of most branch blood vessels.

[0099] 3) The structure of the window assembly 11 will not limit the entry position of the branch stent graft system, and the entry position of the branch stent graft system can be selected according to the actual situation of the patient's blood vessels, that is, the branch stent graft system can enter entirely from the femoral artery (lower access). The first choice is that the branch stent graft system enters entirely from the lower access, which is not only much more convenient to operate than the upper access, but also can reduce postoperative brain complications caused by the detachment of plaques on the inner wall of the branch blood vessels caused by the upper access, and greatly reduce the operation time; 4) The fenestration assembly 11 has a first reinforcement structure 113 and a second reinforcement structure 114, which can maintain the shape of the fenestration even when the blood vessel is compressed, maintain the blood flow of the branch blood vessels, and facilitate the superselection of the guide wire during the operation; the risk of stroke during and after the operation can be reduced; 5) The window assembly 11 has a first developing structure 115, a second developing structure 116, and a third developing structure 117. During the transportation process and the superselection process, the position of the window can be clearly displayed under X-rays, which facilitates the positioning of the windowed stent 1, the superselection of the guide wire, and the positioning of the branch stent during the operation, thereby improving the success rate of the operation.

[0100] 1) Clinical CTA: Ten clinical cases were performed using the stent graft system made by the technology of the present invention. Postoperative CTA showed that there was no endoleak between the branch stent graft and the fenestration component, and the branch stent graft was well aligned. The shortest operation time was only 61 minutes, and the average was only 112 minutes. The preoperative and postoperative CTA showed that Fig.16 , Fig.17 shown.

[0101] 2) Finite element analysis: Finite element analysis showed that for the model without sealing area, there was internal leakage between the fenestration assembly and the branch stent graft. For the model with sealing area, there was no internal leakage in the same place. Fig.18 , Fig.19 shown. Fig.18 The velocity cloud map and streamline map are displayed. The left picture is a model without a sealing area. The streamlines between the window assembly and the branch coated stent are regular, and there is internal leakage. The right picture is a model with a sealing area. There is a vortex between the window assembly and the branch coated stent, and there is no internal leakage. Fig.19 The velocity cloud map is displayed. The left picture is a model without a sealing area. The flow velocity between the window assembly and the branch coated stent is greater than 0.05m / s, and there is internal leakage. The right picture is a model with a sealing area. The flow velocity between the window assembly and the branch coated stent is 0, and there is no internal leakage.

Claims

1. A stent graft system, comprising: a. A stent graft, comprising: i. a positioning component; ii. a first branch vessel window assembly (11), the first branch vessel window assembly (11) comprising a first sealing area (111) and a first adjustment area (112); the first sealing area (111) comprising a third opening (1112); The first adjustment area (112) comprises a first opening (1121), a second opening (1122), a first reinforcement structure (113), and a second reinforcement structure (114); b. a first branch stent graft, the first branch stent graft being used for being released in the first branch blood vessel fenestration assembly (11); Features: The first reinforcing structure (113) maintains the first opening (1121), and the second reinforcing structure (114) maintains the second opening (1122); The first adjustment area (112) is located between the first reinforcement structure (113) and the second reinforcement structure (114); The first adjustment area (112) enables the second opening (1122) to move relative to the positioning assembly; The first sealing area (111) extends from the second reinforcing structure (114) to the third opening (1112), so that the first branch stent graft is sealed and connected to the first sealing area (111) when released; and The first branch coated stent includes a first connection anchoring segment, and the diameter of the first connection anchoring segment after release is larger than the first opening (1121) of the first adjustment zone, so that the first connection anchoring segment is retained at the proximal end of the first opening (1121) of the first adjustment zone.

2. The stent graft system according to claim 1, characterized in that: The sealing area (111) extends from the second reinforcement structure to the third opening (1112), and the extension is from the second reinforcement structure towards the adjustment area (112).

3. The stent graft system according to claim 1, characterized in that: The sealing area (111) extends from the second reinforcement structure to the third opening (1112), and the extension is extending from the second reinforcement structure to another direction of the adjustment area (112).

4. The stent graft system according to claim 1, characterized in that: The sealing area (111) extends from the second reinforcement structure to the third opening (1112), and the extension is simultaneously extended in a direction from the second reinforcement structure to the adjustment area (112) and in another direction.

5. The stent graft system according to claim 1, characterized in that: The first reinforcing structure (113) comprises a first developing structure (115); The second reinforcing structure (114) comprises a second developing structure (116); or The first adjustment area (112) comprises a third developing structure (117).

6. The stent graft system according to claim 1, characterized in that: The positioning assembly comprises a positioning sealing area (111) and a positioning adjustment area (112); the positioning sealing area (111) comprises a positioning third opening (1112); the positioning adjustment area (112) comprises a positioning first opening (1121), a positioning second opening (1122), a positioning first reinforcement structure (113), and a positioning second reinforcement structure (114).

7. The stent graft system according to claim 6, characterized in that: The stent graft further includes a positioning branch stent graft, and the positioning branch stent graft is used for implanting the positioning component.

8. The stent graft system according to claim 1, characterized in that: The first connecting anchoring section includes a flange bracket and a flange covering.

9. The stent graft system according to claim 1, characterized in that: The relative sizes of the first opening (1121), the second opening (1122) and the third opening (1112) are selected from one or more of the following: a. The first opening (1121) is larger than or equal to the second opening (1122); b. The second opening (1122) is larger than or equal to the third opening (1112).

10. The stent graft system according to claim 1, characterized in that: The first adjustment area (112) or the first sealing area (111) comprises a layer of flexible cylindrical or truncated cone-shaped film.

11. The stent graft system according to claim 1, characterized in that: The shape of the first opening (1121), the second opening (1122) or the third opening (1112) is circular or quasi-circular.

12. The stent graft system according to claim 1, characterized in that: The first reinforcement structure (113) or the second reinforcement structure (114) is made of a superelastic material.

13. The stent graft system according to claim 1, characterized in that: The connection between the first sealing area (111) and the first branch stent graft is a planar connection.

14. The stent graft system according to claim 1, characterized in that: The stent graft system further comprises a second branch vessel fenestration assembly and a second branch stent graft; The second branch blood vessel window assembly comprises a second sealing area (111) and a second adjustment area (112); the second sealing area (111) comprises a third opening (1112); the second adjustment area comprises a first opening (1121), a second opening (1122), a first reinforcement structure (113), and a second reinforcement structure (114); The second branch stent graft comprises a second connection anchoring section, and the diameter of the second connection anchoring section after release is larger than the first opening (1121) of the second adjustment zone, so that the second connection anchoring section is retained outside the second adjustment zone (112); The positioning component is used for implantation in the left common carotid artery; the first branch vessel window component is used for implantation in the innominate artery; and the second branch vessel window component is used for implantation in the left subclavian artery.

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