Covered stent system

Abstract

Provided is a covered stent system. The covered stent system comprises: a) a covered stent, comprising: i) a positioning assembly, and ii) a first branch blood vessel fenestration assembly, wherein the first branch blood vessel fenestration assembly comprises a first sealing region and a first adjustment region; the first sealing region comprises a third opening; the first adjustment region comprises a first opening, a second opening, a first reinforcement structure, and a second reinforcement 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 fenestration assembly.

Description

A covered scaffold system Technical Field

[0001] This invention relates to a covered stent with a fenestration for the treatment of vascular diseases involving the main and branch vessels. Background Technology

[0002] This invention is suitable for the treatment of diseases involving the main and branch vessels. For ease of explanation, the following example is aortic dissection involving the aortic arch and supra-arch branches.

[0003] As shown in Figures 1A and 1B, the aortic arch region consists of the ascending aorta 31, the brachiocephalic artery 32, the left common carotid artery 33, the left subclavian artery 34, and the descending aorta 35. Aortic dissection is a disease caused by hemorrhage within the aortic wall, resulting in damage to the tunica media, leading to the separation of the vessel walls and the subsequent formation of interconnected or non-interconnected true lumens 36 and false lumens 37. In most cases, aortic dissection begins with a tear in the intima, through which blood enters the tunica media 38, eventually leading to rupture of the aorta or re-entering the true lumen through a second intima tear. Based on the location of the dissection, aortic dissection is classified into Stanford type A dissection (dissection involving the ascending aorta), Stanford type B dissection (dissection involving only the descending aorta), and non-A / non-B type dissection (dissection involving the aortic arch but not the ascending aorta).

[0004] The prevalence of aortic dissection in China is 0.07%. [1] Of the new aortic dissections each year, type A dissections account for about 60%, and non-A, non-B dissections account for about 10%.

[0005] For type A aortic dissection and non-type A / non-B aortic dissection, because the lesion involves three branches of the ascending aorta and aortic arch, and the structural relationships between the main trunk and branches in this area vary from patient to patient—including the location of branch openings, the distance between branches, and the direction of branch openings—there is currently no standardized interventional stent product suitable for lesions involving two or more branches that accommodates these differences. Therefore, open-chest surgery under cardiopulmonary bypass remains the conventional approach. However, surgical intervention presents the following challenges:

[0006] 1) The procedure is complex, time-consuming, and difficult to promote: As shown in Figure 2, the surgery needs to be performed under cardiopulmonary bypass. The surgeon dissects and removes the entire aortic arch, replaces it with an artificial blood vessel (4), and completes end-to-end sutures between the artificial and autologous blood vessels at at least five sites (ascending aorta 41, brachiocephalic artery 42, left common carotid artery 43, left subclavian artery 44, descending aorta 45). The surgery takes approximately 6-10 hours, with an average cardiopulmonary bypass time of 2-3 hours, an average aortic clamping time of 1.5-2 hours, and an average deep hypothermic circulatory arrest time of 20-30 minutes. In short, the procedure is complex, time-consuming, and requires a long learning curve for surgeons, making it difficult to promote.

[0007] 2) Deep hypothermia with prolonged circulatory arrest can easily lead to ischemia of organs and lower limbs: Deep hypothermia with an average circulatory arrest time of 20-30 minutes can easily cause ischemic and hypoxic damage to various organs, and deep hypothermia can easily lead to pathophysiological changes in various organs.

[0008] 3) The end-to-end suturing of the above-mentioned parts is difficult, the anastomosis is prone to bleeding, and there is a lot of bleeding at the junction of the free original arch serosa; all of the above make hemostasis difficult.

[0009] 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 failure 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 the disease are very rapid (the mortality rate of type A aortic dissection is 40% to 50% within 48 hours after onset), and the transfer time for patients is long. Therefore, many patients die before they receive treatment.

[0010] With the increasing number of hypertension patients worldwide, the prevalence of the aforementioned diseases is also rising annually. Due to these characteristics, many patients cannot receive timely treatment locally and thus lose their lives, making this disease a long-standing challenge for clinicians. For over a decade, doctors around the world have repeatedly attempted to use interventional endovascular repair techniques to treat the condition and alleviate the aforementioned clinical difficulties. The main methods are as follows:

[0011] 1) In situ fenestration technique: A straight cylindrical thoracic aortic endovascular stent graft is implanted into the aortic arch region via a catheter. The endovascular stent graft is ruptured in situ at the corresponding positions of the three branch vessels on the aortic arch. The rupture site is then balloon-dilated. Through the dilated rupture site, the corresponding branch endovascular stent grafts are implanted one by one via a catheter. This technique has the following problems: a) After implantation of the thoracic aortic endovascular stent graft but before rupture and fenestration, the corresponding branch vessel openings are isolated by the thoracic aortic endovascular stent graft and are in an ischemic state. If the ischemic state is prolonged, it can cause extremely serious cerebral complications; b) The rupture and fenestration of the thoracic aortic endovascular stent graft are physical tears. After the branch endovascular stent graft is implanted, the fit between it and the rupture is often not tight, resulting in a high incidence of endoleak (blood flows out from the gap between the rupture and the branch endovascular stent graft). The false lumen continues to expand, and patients often need a second surgical intervention; c) The surgical procedure is complex, takes a long time, and is not easy to promote; d) The procedures such as rupture and branch endovascular stent graft implantation are mostly performed through arteries in the neck or right arm (such as the brachial artery) and supra-arch branches as the access (referred to as the upper access in the interventional field). The instruments move back and forth in these branch vessels, which can easily cause plaques (most of which are plaques) to detach and lead to intraoperative cerebral infarction, or cause damage to the intima of the branch vessels, forming plaques that eventually detach and lead to cerebral infarction.

[0012] 2) Embedded Tunnel, Modular Bridging Technique: A thoracic aortic stent graft with three internal tunnels is implanted via catheter into the aortic arch region. These three internal tunnels serve as interfaces for bridging the thoracic aortic stent graft with its branches. The internal tunnels corresponding to the brachiocephalic artery and the left common carotid artery extend from the root of their respective branches into the ascending aorta, while the internal tunnel corresponding to the left subclavian artery extends from the root of the left subclavian artery into the descending aorta. The catheter is used to implant the branch stent grafts corresponding to the brachiocephalic artery and the left common carotid artery one by one via the upper access route, and the branch stent graft corresponding to the left subclavian artery is implanted via the femoral artery approach (referred to as the lower access route in interventional medicine). This technique also has the following problems: the branch stent grafts for the brachiocephalic artery and the left common carotid artery are implanted through the upper access route, which not only makes the operation time longer and more difficult, but also increases the risk of plaque detachment and intraoperative stroke due to many procedures being performed within the branch vessels of the aortic arch, or damage to the intima of the branch vessels leading to plaque formation and eventual detachment and stroke.

[0013] 3) Hybrid Surgery: Hybrid surgery generally consists of two steps: First, a surgical bypass is performed in the neck between the brachiocephalic artery and the left common carotid artery and left subclavian artery using an artificial blood vessel; then, a branched interventional stent graft with a brachiocephalic artery stent is implanted via catheter into the brachiocephalic artery in the aortic arch region. This establishes blood supply between the branch vessels in this area. This technique requires two stages, is complex, and involves a long waiting time for the patient. Neck bypass surgery may lead to complications such as bleeding and infection, and this reconstruction method significantly alters the original blood flow pattern of the supra-aortic branches, potentially causing stenosis or blockage of the bypassed vessels.

[0014] The above methods have drawbacks such as long operation time, complex operation, various complications, lack of standardization of instruments and surgical methods, and inability to be promoted in most hospitals. Summary of the Invention

[0015] This invention provides a covered stent system. In one embodiment, the covered stent system includes a) a covered stent, comprising: i) a positioning component; ii) a first branch vessel fenestration component, the first branch vessel fenestration component including a first sealing region and a first adjustment region; the first sealing region including a third opening; the first adjustment region including a first opening, a second opening, a first reinforcing structure, and a second reinforcing structure; b) a first branch covered stent, the first branch covered stent being deployed within the first branch vessel fenestration component; the first reinforcing structure maintaining the first opening, and the second reinforcing structure maintaining the second opening; the first adjustment region being located between the first reinforcing structure and the second reinforcing structure; the first adjustment region enabling the second opening to move relative to the positioning component; the first sealing region extending from the second reinforcing structure to the third opening, such that after the first branch covered stent is deployed, it forms a planar sealing connection with the first sealing region; and the first branch covered stent includes a first connecting anchor section, the diameter of the first connecting anchor section after deployment being larger than the first opening of the first adjustment region, such that the first connecting anchor section remains proximal to the first opening of the first adjustment region.

[0016] The present invention further provides a method for implanting a covered stent into a blood vessel, the blood vessel including a main trunk, a positioning branch vessel, and a first branch vessel. In one embodiment, the method includes the following steps: a) providing a covered stent system according to the present invention; b) delivering the covered stent into the main trunk of the blood vessel; c) aligning the positioning component with the positioning branch vessel; d) releasing the covered stent, such that the covered stent adheres to the inner wall of the main trunk and the positioning component is aligned with the root of the positioning branch vessel; e) delivering the first branch covered stent into the first branch vessel through a first branch vessel fenestration component; f) releasing the first branch covered stent, such that a second opening is aligned with the root of the first branch vessel, such that a first sealing area is planarly sealed to the first branch covered stent, and the first connection anchoring segment remains proximal to the first opening of the first adjustment area. Attached Figure Description

[0017] Figure 1A shows a schematic diagram of a normal aorta. Figure 1B shows a schematic diagram of aortic dissection.

[0018] Figure 2 shows five artificial blood vessels sutured end-to-end with autologous blood vessels during surgery.

[0019] Figure 3 is a front view of the film-coated support with window opening components.

[0020] Figure 4 is a front view of the window assembly.

[0021] Figure 5 is a top view of the window opening assembly.

[0022] Figure 6 is a front view of the window assembly.

[0023] Figure 7 is a cross-sectional view of the first reinforcing structure (second reinforcing structure) and the first developing structure (second developing structure).

[0024] Figure 8 shows the fenestrated covered stent aligned with the root and middle of the left common carotid artery during insertion (before the fenestrated covered stent is released and deployed).

[0025] Figure 9 shows a schematic diagram of the covered support with windows after release and unfolding.

[0026] Figure 10 shows a schematic diagram of a branched covered stent loaded in a delivery system being delivered to the left common carotid artery.

[0027] Figure 11 shows a schematic diagram of the left common carotid artery branch covered stent after release and deployment.

[0028] Figure 12 shows a schematic diagram of delivering a branched covered stent, loaded in a delivery system, to the brachiocephalic artery. At this point, the second opening is still misaligned with the root of the branch vessel.

[0029] Figure 13A shows a schematic diagram of the misalignment between the second opening and the root of the branch vessel.

[0030] Figure 13B shows a schematic diagram of the second opening aligned with the root of the branch vessel.

[0031] Figure 14 shows a schematic diagram of the stent graft covering the branch of the innominate artery after release and deployment. At this point, the second opening is aligned with the root of the branch vessel.

[0032] Figure 15 shows a schematic diagram of the left subclavian artery branch covered stent after release and deployment. At this time, the second opening is aligned with the root of the branch vessel.

[0033] Figure 16 shows the clinical CT angiography of clinical cases 001-005 before and after the operation.

[0034] Figure 17 shows the clinical CT angiography of clinical cases 006-010 before and after the operation.

[0035] Figure 18 shows a comparison of velocity contour plots and streamline plots between models with and without sealed regions in finite element analysis.

[0036] Figure 19 shows a comparison of velocity contour plots between the model with and without a sealed region in finite element analysis. Detailed Implementation

[0037] Diseases involving both main and branch blood vessels are currently considered the most life-threatening cardiovascular diseases, requiring emergency transfer to large cardiac centers for highly invasive surgery to achieve treatment. Patients often lose their lives due to delayed treatment. Furthermore, even with timely treatment, the surgical mortality rate is as high as 10%-33%, and the incidence of various postoperative complications is as high as 4%-30%. This has long been a major challenge in the clinical treatment of such patients. The main beneficial effects of this invention are as follows:

[0038] 1) It can replace most of the open-heart or open-abdomen surgery that currently requires deep hypothermic circulatory arrest under cardiopulmonary bypass. It only requires catheter intervention to treat related diseases, greatly reducing trauma and the high surgical mortality and high complication rate caused by surgery. It has created a brand-new treatment method for diseases involving branch vessels.

[0039] 2) The above-mentioned innovative inventions can all be implanted via lower limb artery intervention. The devices of this invention are simple to operate, easy to learn, and easy to promote to most intermediate hospitals. This changes the current situation where such patients need to be sent to large hospitals hundreds of kilometers away for emergency surgery. It enables many patients to receive timely and rapid treatment in local hospitals, which greatly improves the survival rate of such patients.

[0040] 3) The use of catheter-based interventional methods and instruments to treat vascular diseases involving branch vessels is far less expensive than surgical treatment, and has great clinical and social significance.

[0041] For the treatment of diseases involving both the main and branch vessels, this invention provides a covered stent with a fenestration component. This covered stent, combined with a branch covered stent, can reconstruct the diseased vessel. For example, in patients with type A and non-type A and non-B dissections (including aneurysms, intramural hematomas, and multiple penetrating ulcers in this area), the covered stent provided by this invention can reconstruct the diseased aorta.

[0042] This invention provides a covered stent system. In one embodiment, the covered stent system includes a) a covered stent, comprising: i) a positioning component; ii) a first branch vessel fenestration component 11, the first branch vessel fenestration component 11 including a first sealing region 111 and a first adjustment region 112; the first sealing region 111 including a third opening 1112; the first adjustment region including a first opening 1121, a second opening 1122, a third opening 1112, a first reinforcing structure 113, and a second reinforcing structure 114; b) a first branch covered stent, the first branch covered stent being deployed within the first branch vessel fenestration component 11; the first reinforcing structure 113 maintaining the first opening 1121 and the second reinforcing structure 114. The second opening 1122 is held; the first adjustment area 112 is located between the first reinforcing structure 113 and the second reinforcing structure 114; the first adjustment area 112 allows the second opening 1122 to move relative to the positioning component; the first sealing area 111 extends from the second reinforcing structure 114 to the third opening 1112, so that after the first branch film-coated bracket is released and unfolded, it forms a planar sealing connection with the first sealing area 111; and the first branch film-coated bracket includes a first connecting anchor section, the diameter of the first connecting anchor section after release is larger than the first opening 1121 of the first adjustment area, so that the first connecting anchor section is retained at the proximal end of the first opening 1121 of the first adjustment area.

[0043] In one embodiment, the sealing area 111 extends from the second reinforcing structure to the third opening 1112, the extension being from the second reinforcing structure toward the adjustment area 112.

[0044] In one embodiment, the sealing area 111 extends from the second reinforcing structure to the third opening 1112, the extension being an extension from the second reinforcing structure in another direction toward the adjustment area 112.

[0045] In one embodiment, the sealing area 111 extends from the second reinforcing structure to the third opening 1112, the extension being simultaneously from the second reinforcing structure toward the adjustment area 112 and in another direction.

[0046] 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 adjustment region 112 includes a third developing structure 117.

[0047] In one embodiment, 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 reinforcing structure 113, and a positioning second reinforcing structure 114.

[0048] In one embodiment, the covered stent further includes a positioning branch covered stent for implanting the positioning component.

[0049] In one embodiment, the first connection anchoring section includes a flange bracket and a flange liner.

[0050] 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.

[0051] In one embodiment, the first adjustment region 112 or the first sealing region 111 is a flexible cylindrical or frustum-shaped film.

[0052] In one embodiment, the first opening 1121, the second opening 1122, or the third opening 1112 is circular or similar in shape.

[0053] In one embodiment, the first reinforcing structure 113 or the second reinforcing structure 114 is made of a superelastic material (metal, alloy, polymer, etc.).

[0054] In one embodiment, the connection between the first sealing area 111 and the first branch film-coated bracket is a planar connection.

[0055] In one embodiment, the covered stent system further includes a second branch vessel fenestration assembly and a second branch covered stent; the second branch vessel fenestration assembly includes a second sealing region 111 and a second adjustment region 112; the second sealing region 111 includes a third opening 1112; the second adjustment region includes a first opening 1121, a second opening 1122, a first reinforcing structure 113, and a second reinforcing structure 114; the second branch covered stent includes a second connecting anchor segment, the diameter of which after release is larger than the first opening 1121 of the second adjustment region, so that the second connecting anchor segment remains proximal to the first opening 1121 of the second adjustment region; the positioning assembly is used for implantation into the left common carotid artery; the first branch vessel fenestration assembly is used for implantation into the brachiocephalic artery; and the second branch vessel fenestration assembly is used for implantation into the left subclavian artery.

[0056] The present invention further provides a method for implanting a covered stent into a blood vessel, the blood vessel including a main trunk, a positioning branch vessel, and a first branch vessel. In one embodiment, the method includes the following steps: a) providing a covered stent system according to the present invention; b) delivering the covered stent into the main trunk of the blood vessel; c) aligning the positioning component with the positioning branch vessel; d) releasing the covered stent so that the covered stent adheres to the inner wall of the main trunk and the positioning component is aligned with the root of the positioning branch vessel; e) delivering the first branch covered stent into the first branch vessel through the first branch vessel fenestration component 11; f) releasing the first branch covered stent so that the second opening is aligned with the root of the first branch vessel, so that the first sealing area 111 is in planar sealing connection with the first branch covered stent, and the first connection anchoring segment remains at the proximal end of the first opening 1121 of the first adjustment area.

[0057] In one embodiment, the blood vessel is the aortic arch, and the locating branch vessel or the first branch vessel is selected from one of the left common carotid artery, the brachiocephalic artery, and the left subclavian artery.

[0058] In one embodiment, the blood vessel is the abdominal aorta, and the locating branch vessel or the first branch vessel is selected from one of the celiac trunk, left renal artery, right renal artery and superior mesenteric artery.

[0059] In one embodiment, the blood vessel is the aortic root and the ascending aorta, and the locating branch vessel or the first branch vessel is selected from one of the left coronary artery and the right coronary artery.

[0060] In one embodiment, the blood vessel is any artery or vein with two or more branches, and the locating branch vessel or the first branch vessel is selected from one of the branches of the blood vessel.

[0061] In one embodiment, step (d) further includes: i) delivering a positioning branch covered stent to the positioning vessel via the positioning component; the positioning component includes a positioning sealing region 111 and a positioning adjustment region 112; the positioning sealing region 111 includes a positioning third opening 1112; the positioning adjustment region 112 includes a positioning first opening 1121, a positioning second opening 1122, a positioning first reinforcing structure 113, and a positioning second reinforcing structure 114; the positioning branch covered stent includes a positioning connection anchoring section, the diameter of which after release is larger than that of the positioning first opening 1121, so that the positioning connection anchoring section remains proximal to the first opening 1121 in the positioning adjustment region; ii) releasing the positioning branch covered stent, aligning the positioning second opening with the root of the positioning branch vessel, the positioning sealing region 111 and the positioning branch covered stent forming a planar sealed connection, and the first connection anchoring section of the positioning branch covered stent remaining proximal to the first opening 1121 in the positioning adjustment region.

[0062] The main technical problem solved by this invention is:

[0063] 1) The sealing area 111 of the window opening component of the present invention is a cylindrical or frustum-shaped flexible membrane structure. This flexible membrane structure can ensure the sealing between the window opening component and the branch covered stent, effectively prevent internal leakage, and solve the problem of internal leakage that may occur after the branch covered stent is implanted in various window opening design principles.

[0064] 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 move and adjust within a certain range, so as to adapt to the anatomical differences in most main trunk and branch blood vessels.

[0065] 3) The structure of the fenestration component of this invention does not restrict the access position of the branch covered stent system. All branch covered stents can be implanted through the femoral artery (lower access). This avoids the problem of postoperative brain complications caused by plaque detachment from the inner wall of the branch vessel when the technology such as embedded tunnel and modular bridging enters from the upper access. It can shorten the operation time, facilitate the operation of doctors and promote the promotion of the surgery.

[0066] 4) The fenestration of the present invention has a reinforced structure, which can isolate the blood vessel wall and lesion site (false lumen, hematoma, etc.) after the covered stent is implanted into the blood vessel. Even when the blood vessel is compressed, the shape of the fenestration can be maintained to maintain the blood flow of the branch blood vessel and solve the problem of cerebral blood supply that may occur when other technologies only have a concave structure. At the same time, it facilitates the superselection of the guidewire during the operation (superselection refers to the selective entry of the catheter or guidewire into the target branch blood vessel).

[0067] 5) The fenestration component of the present invention has a imaging structure, which can clearly display the position of the fenestration component under X-ray during the transport and superselection processes, facilitating the intraoperative positioning of the covered stent, the superselection of the guidewire, and the intraoperative positioning of the branched covered stent.

[0068] The above features of the present invention are suitable for the repair and reconstruction of most lesions with anatomical differences in the main trunk and branch vessels (including dissecting aneurysms, true aneurysms, intramural hematomas, and multiple penetrating ulcers), such as the aortic arch and the three branches above the arch, as well as the abdominal aorta and the left and right renal arteries, superior mesenteric artery, and celiac trunk artery, etc.

[0069] In one embodiment of the invention, the cooperation between different components within the covered stent system effectively prevents endoleak problems that may occur after the branch covered stent is implanted. In one embodiment, the connecting anchoring segment of the branch covered stent, after release, has a diameter larger than the first opening 1121 of the adjustment zone and is anchored proximal to 1121, thus serving as the primary means of fixing the branch covered stent. The connecting anchoring segment of the branch covered stent bears most of the force fixing the branch covered stent, preventing the branch covered stent from detaching from the fenestration assembly, thereby preventing type III endoleak. When the branch vessel structure differs and the fenestration assembly is misaligned, the first reinforcing structure 113 and the second reinforcing structure 114 can maintain the shape of the first opening 1121 and the second opening 1122, facilitating guidewire overselection; simultaneously, the second opening 1122 of the adjustment zone can automatically adjust its position when the branch covered stent is released, so that the second opening 1122 automatically aligns with the root of the branch vessel, thereby correcting misalignment and preventing the branch covered stent from twisting. After the branch-covered support is released and deployed, the sealing area 111 is a cylindrical or frustum-shaped flexible membrane structure. This flexible membrane structure forms a surface-to-surface seal with the branch-covered support, effectively preventing internal leakage.

[0070] This invention describes a covered stent with a fenestration assembly for treating vascular diseases involving both main and branch vessels. The device is a covered stent with a fenestration assembly, comprising a fenestration assembly 11, a columnar covering 12, and a stent ring 13 (as shown in Figure 3). The fenestration assembly 11 consists of a sealing area 111, an adjustment area 112, a first opening 1121, a second opening 1122, a third opening 1112, a first reinforcing structure 113, a second reinforcing structure 114, a first imaging structure 115, a second imaging structure 116, and a third imaging structure 117 (as shown in Figures 4 and 5). The third imaging structure 117 is an optional component.

[0071] A covered stent 1 with a fenestration assembly is used to treat vascular diseases involving the main and branch vessels. It is an assembly composed of multiple components through a certain process, and includes at least one fenestration assembly 11.

[0072] The window opening assembly 11 is a connection structure between the windowed film-coated bracket 1 and the branch film-coated bracket. It is an assembly composed of multiple components combined through a certain process.

[0073] The columnar coating 12 is a flexible cylindrical or frustum-shaped thin film attached to the scaffold ring 13 by means of sewing or heat fusion, and its material is a biocompatible material.

[0074] The support ring 13 is a wavy or mesh-like wire frame.

[0075] The sealing area 111 is a flexible cylindrical or frustum-shaped film that extends upwards and is attached to the second opening 1122 of the adjustment area 112 by means of sewing or heat fusion. The material is a biocompatible material. Optionally, the sealing area 111 extends upwards and downwards simultaneously from the second opening 1122, as shown in Figure 6.

[0076] The adjustment zone 112 is a flexible cylindrical or frustum-shaped thin film attached to the columnar coating 12 by means of sewing or heat fusion, with a first opening 1121 and a second opening 1122 at both ends, and its material is a biocompatible material.

[0077] The first opening 1121 is the opening of the adjustment area 112 on the side near the columnar covering film 12, and its shape is circular or similar to a circle.

[0078] The second opening 1122 is an opening on the side of the adjustment area 112 away from the columnar covering film 12. Its shape is circular or similar to a circle, and its diameter or circumference is smaller than that of the first opening 1121.

[0079] The third opening 1112 is the opening on the side of the sealing area 111 away from the adjustment area 112. Its shape is circular or similar to a circle, and its diameter or circumference is less than or equal to the diameter or circumference of the second opening 1122.

[0080] The first reinforcing structure 113 is a ring-shaped metal attached to the first opening 1121 by means of sewing or hot melting. Its material is superelastic, such as nickel-titanium alloy, and has a certain degree of imaging effect.

[0081] The second reinforcing structure 114 is a ring-shaped metal attached to the second opening 1122 by means of sewing or hot melting. Its material is superelastic, such as nickel-titanium alloy, and has a certain degree of imaging effect.

[0082] The first imaging structure 115 is a spiral metal attached to the first reinforcing structure 113 by winding. The material has good imaging properties under X-rays, such as platinum alloy or gold. Optionally, the first imaging structure 115 is located at the center of the cross-section of the first reinforcing structure 113, as shown in Figure 7.

[0083] The second imaging structure 116 is a spiral metal attached to the second reinforcing structure 114 by winding. The material has good imaging properties under X-rays, such as platinum alloy or gold. Optionally, the second imaging structure 116 is located at the center of the cross-section of the second reinforcing structure 114, as shown in Figure 7.

[0084] The third imaging structure 117 is a ring or disc-shaped metal attached to the adjustment area 112 by means of sewing or hot melting. The material has good imaging effect under X-ray, such as platinum alloy or gold.

[0085] The functions of each component in this embodiment are described below:

[0086] The covered stent 1 with fenestration component is used to treat vascular diseases involving branch vessels, reconstructing branch vessels while reconstructing the main trunk vessels, and maintaining the patency of the branch vessels.

[0087] The fenestration component 11, as a structure connected to the branch covered stent, can be combined with the branch covered stent when the columnar covered stent 12 and the stent ring 13 are fixed in the main blood vessel, adapting to different vascular anatomy structures.

[0088] The columnar covering 12 ensures that blood flow does not leak to the outside of the covered stent, and together with the stent ring 13, it can seal the vascular intima rupture or the aneurysm cavity.

[0089] The stent ring 13 provides radial support, which allows the columnar cladding 12 to be stably supported in the main blood vessel and supports the function of expanding the true lumen and narrowing the false lumen.

[0090] The sealing area 111 ensures the sealing between the branch film support and the window assembly 11, reducing internal leakage.

[0091] The adjustment zone 112 allows the second opening 1122 to move and rotate within a certain range to adapt to different branch vascular anatomy structures.

[0092] The first opening 1121 allows blood to flow into the regulation zone 112.

[0093] The second opening 1122 allows blood to flow into the sealed area 111.

[0094] The third opening 1112 allows blood to flow out of the sealed area 111.

[0095] The first reinforcing structure 113 maintains the shape of the first opening 1121, ensures unobstructed blood flow to the branch vessels during and after the operation, and facilitates superselection during the operation.

[0096] The second reinforcing structure 114 maintains the shape of the second opening 1122, ensures unobstructed blood flow to the branch vessels during and after the operation, and facilitates superselection during the operation.

[0097] The first imaging structure 115 makes the shape of the first opening 1121 more obvious under intraoperative X-ray, thereby facilitating the intraoperative positioning of the covered stent 1 with fenestration assembly, the superselection of branches, and the positioning of the branch covered stent.

[0098] The second imaging structure 116 makes the shape of the second opening 1122 more obvious under intraoperative X-ray, thereby facilitating the intraoperative positioning of the covered stent 1 with fenestration assembly, the superselection of branches, and the positioning of the branch covered stent.

[0099] The third imaging structure 117 makes the position of the fenestration component 11 more obvious under intraoperative X-ray, thereby facilitating the intraoperative positioning of the covered stent 1 with the fenestration component, the superselection of branches, and the positioning of the branch covered stent.

[0100] Surgical procedure description:

[0101] In this invention, the surgical treatment of vascular diseases involving both the main and branch vessels can be simplified to the following five steps. Here, for ease of explanation, the aortic arch region is selected as the area requiring reconstruction:

[0102] i. As shown in Figure 8, the fenestrated covered stent 1 is loaded into the delivery system. The fenestrated covered stent 1 has three fenestrated components 11, corresponding from left to right to the brachiocephalic artery, the left common carotid artery, and the left subclavian artery, respectively. The delivery system is delivered to the designated location by aligning the imaging structures (first imaging structure 115, second imaging structure 116, or third imaging structure 117) in the fenestrated component 11 at the root of the left common carotid artery and in the middle.

[0103] ii. As shown in Figure 9, the fenestrated covered stent 1 is released into the aorta. At this time, the fenestrated covered stent 1 adheres to the inner wall of the aorta, and the fenestrated component 11 in the middle is aligned with the root of the left common carotid artery.

[0104] iii. As shown in Figure 10, the branched covered stent 2 is loaded into the delivery system, and the delivery system is delivered to the designated location by aligning the imaging structure (first imaging structure 115) in the intermediate fenestration assembly 11 with the imaging structure (the first stent near the heart end) on the branched covered stent.

[0105] iv. As shown in Figure 11, the branch stent graft 2 of the left common carotid artery is released. At this time, the end of the branch stent graft closer to the heart is abutted against the sealing area 111 of the fenestrated component 11 of the stent graft 1 with fenestration, and the end away from the heart is abutted against the inner wall of the branch vessel.

[0106] v. As shown in Figure 12, the branched covered stent is loaded into the delivery system. By aligning the imaging structure (first imaging structure 115) in the leftmost fenestration assembly 11 with the imaging structure on the branched covered stent (the first stent near the heart end), the delivery system is delivered to the designated location. As shown in Figures 13A and 13B, when the second opening 1122 in the leftmost fenestration assembly 11 is misaligned with the root of the brachiocephalic artery 321, the adjustment area 112 in the fenestration assembly 11 allows the second opening 1122 to move and rotate within a certain range. When the guidewire is overselected, the branched covered stent system is pushed, and the branched covered stent is released, the second opening 1122 can adjust its position and angle to align with the root of the brachiocephalic artery 321.

[0107] vi. As shown in Figure 14, the branch stent graft of the brachiocephalic artery is released. At this time, the end of the branch stent graft closer to the heart is abutted against the sealing area 111 of the fenestrated component 11 of the stent graft 1 with fenestration, and the end away from the heart is abutted against the inner wall of the branch vessel.

[0108] vii. As shown in Figure 15, repeat steps v and vi to implant a endovascular stent graft covering the left subclavian artery branch, completing vascular reconstruction in the aortic arch region.

[0109] For endovascular treatment of vascular diseases involving both main and branch vessels, techniques such as in-situ fenestration, embedded tunneling, and modular bridging face significant challenges, including differences in branch vessel anatomy, endoleaks, the need for branch-covered stents to be implanted distal to the branch, complex procedures, and long operation times. This case offers the following innovations to address these issues:

[0110] 1) The sealing area 111 of the window opening assembly 11 ensures the seal between the window opening assembly 11 and the branch membrane support, effectively preventing internal leakage. The sealing area 111 is a planar leak-proof structure, and its leak-proof effect is far superior to that of a linear leak-proof structure. In one embodiment, the sealing area 111 is a cylindrical or frustum-shaped flexible membrane structure.

[0111] 2) The opening position and angle of the fenestration component 11 of the present invention can be adjusted within a certain range, which can adapt to the anatomical differences in most branch vessels due to individual variations. Furthermore, it can significantly reduce the size of the covered stent 1 with the fenestration component, thereby reducing its design and manufacturing difficulty and decreasing inventory. In one embodiment, the adjustment area 112 of the fenestration component 11 allows the position and angle of the second opening 1122 to be adjusted within a certain range, adapting to the anatomical differences in most branch vessels.

[0112] 3) The structure of the fenestration component 11 does not restrict the access position of the branched covered stent system. The access position of the branched covered stent system can be selected according to the actual condition of the patient's blood vessels. That is, the branched covered stent system can be fully entered through the femoral artery (lower access). Entering the branched covered stent system entirely through the lower access is the first choice. It is not only much more convenient to operate than the upper access, but it can also reduce postoperative cerebral complications caused by plaque dislodgement from the inner wall of the branch vessels that may occur with the upper access, and at the same time, it greatly reduces the operation time.

[0113] 4) The fenestration assembly 11 has a first reinforcing structure 113 and a second reinforcing structure 114, which can maintain the shape of the fenestration even when it is compressed in the blood vessel, maintain blood flow in the branch vessel, and facilitate the superselection of the guidewire during the operation; it can reduce the risk of stroke during and after the operation.

[0114] 5) The fenestration assembly 11 has a first imaging structure 115, a second imaging structure 116, and a third imaging structure 117. During the transport and superselection processes, the position of the fenestration can be clearly displayed under X-rays, which facilitates the intraoperative positioning of the fenestrated covered stent 1, the superselection of the guidewire, and the intraoperative positioning of the branched covered stent, thereby improving the success rate of the operation.

[0115] 1) Clinical CTA:

[0116] The covered stent system fabricated using the technology of this invention was used in 10 clinical cases. Postoperative CTA showed that there was no endoleak between the branch covered stent and the fenestration component, and the branch covered stent was well aligned. The shortest operation time was only 61 minutes, and the average was only 112 minutes. The preoperative and postoperative CTA are shown in Figure 16 and Figure 17, respectively.

[0117] 2) Finite element analysis:

[0118] Finite element analysis revealed internal leakage between the window assembly and the branch membrane support in the model without a sealing zone. However, no internal leakage was observed in the same area in the model with a sealing zone. This is illustrated in Figures 18 and 19. Figure 18 shows the velocity contour plot and streamline diagram. The left figure shows the model without a sealing zone, where the streamlines between the window assembly and the branch membrane support are regular, indicating internal leakage. The right figure shows the model with a sealing zone, where the flow between the window assembly and the branch membrane support is vortex-like, indicating no internal leakage. Figure 19 shows the velocity contour plot. The left figure shows the model without a sealing zone, where the flow velocity between the window assembly and the branch membrane support is greater than 0.05 m / s, indicating internal leakage. The right figure shows the model with a sealing zone, where the flow velocity between the window assembly and the branch membrane support is 0, indicating no internal leakage.

Claims

1. A covered scaffold system, comprising: a. A covered scaffold, comprising: i. A positioning component; ii. A first branch vessel fenestration assembly (11), the first branch vessel fenestration assembly (11) including a first sealing region (111) and a first adjustment region (112); the first sealing region (111) includes a third opening (1112); The first adjustment area (112) includes a first opening (1121), a second opening (1122), a first reinforcing structure (113), and a second reinforcing structure (114); b. A first branch covered stent for deployment within the first branch vessel fenestration assembly (11); Its features are: The first reinforcing structure (113) maintains the first opening (1121), and the second reinforcing structure (114) maintains the second opening (1122); The first adjustment region (112) is located between the first reinforcing structure (113) and the second reinforcing structure (114); The first adjustment area (112) allows the second opening (1122) to move relative to the positioning component; The first sealing area (111) extends from the second reinforcing structure (114) to the third opening (1112), so that the first branch covered stent and the first sealing area (111) form a sealed connection when the first branch covered stent is released; and The first branch covered stent includes a first connecting anchor section, the diameter of which after release is larger than the first opening (1121) of the first adjustment area, so that the first connecting anchor section remains at the proximal end of the first opening (1121) of the first adjustment area.

2. The covered scaffold system according to claim 1, characterized in that: The sealing area (111) extends from the second reinforcing structure to the third opening (1112), and the extension extends from the second reinforcing structure toward the adjustment area (112).

3. The covered stent system according to claim 1, characterized in that: The sealing area (111) extends from the second reinforcing structure to the third opening (1112), the extension being from the second reinforcing structure in another direction toward the adjustment area (112).

4. The covered scaffold system according to claim 1, characterized in that: The sealing area (111) extends from the second reinforcing structure to the third opening (1112), and the extension extends simultaneously from the second reinforcing structure toward the adjustment area (112) and in another direction.

5. The covered stent system according to claim 1, characterized in that: 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 adjustment region (112) includes a third developing structure (117).

6. The covered scaffold system according to claim 1, characterized in that: 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 reinforcing structure (113), and a positioning second reinforcing structure (114).

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

8. The covered stent system according to claim 1, characterized in that: The first connection anchoring section includes a flange bracket and a flange cover.

9. The covered stent 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 greater than or equal to the second opening (1122); b. The second opening (1122) is greater than or equal to the third opening (1112).

10. The covered stent system according to claim 1, characterized in that: The first adjustment area (112) or the first sealing area (111) includes a flexible cylindrical or frustum-shaped film.

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

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

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

14. The covered stent system according to claim 1, characterized in that: The covered stent system further includes a second branch vessel fenestration assembly and a second branch covered stent; The second branch vessel fenestration 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 reinforcing structure (113), and a second reinforcing structure (114); The second branch covered stent includes a second connecting anchor section, the diameter of which after release is larger than the first opening (1121) of the second adjustment area, so that the second connecting anchor section remains outside the second adjustment area (112); The positioning component is used for implantation into the left common carotid artery; the first branch vessel fenestration component is used for implantation into the brachiocephalic artery; and the second branch vessel fenestration component is used for implantation into the left subclavian artery.

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