A covered stent system

Abstract

The present invention provides a covered stent system, and the covered stent system includes: a) a covered stent, including: i) a positioning component; ii) a first branch vessel fenestration component, the first branch vessel fenestration component including a first sealing area and a first adjustment area; the first sealing area 111 includes a third opening; the first adjustment area includes a first opening, a second opening, a first strengthening structure, and a second strengthening structure; b) a first branch covered stent, which is used to be released within the first branch vessel fenestration component.

Description

Technical Field

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

[0002] The present invention is suitable for the treatment of vascular diseases involving the main trunk and branch vessels. For the convenience of description below, aortic dissection with lesions involving the aortic arch and its supra-arch branches is taken as an example.

[0003] As Figure 1A and Figure 1B shown, the aortic arch region 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 medial layer of the aortic vessel wall is damaged due to hemorrhage within the aortic vessel wall, resulting in the separation of the vessel wall, and subsequently forming a true lumen 36 and a false lumen 37 that are either interconnected or not interconnected. In most cases, aortic dissection begins with an intimal tear, and blood enters the medial layer through the intimal 38 tear, ultimately leading to rupture of the aorta or re-entering the true lumen through a second intimal tear. According to the location of the dissection, aortic dissection is divided into Stanford type A dissection (the dissection involves the ascending aorta), Stanford type B dissection (the dissection only involves the descending aorta), and non-A non-B type dissection (the dissection involves the aortic arch but does not involve the ascending aorta).

[0004] Among the newly added aortic dissections each year, type A dissection accounts for about 60%, and non-A non-B type dissection accounts for about 10%.

[0005] For type A dissection and non-A non-B type dissection, since the lesions involve the ascending aorta and the three branch vessels of the aortic arch, and the structural relationship between the main trunk and branch vessels in this part of each patient, including the opening position of the branch vessels, the distance between the branch vessels, and the opening direction of the branch vessels, are all different. So far, there is no standardized interventional implantable stent product suitable for lesions involving two or more branch vessels and suitable for these differences. Therefore, currently, conventional methods still can only use surgical thoracotomy under extracorporeal circulation. However, surgical operations have the following problems:

[0006] 1) The surgical operation is complex, time-consuming, and the surgical method is not easy to promote: As Figure 2As shown in the figure, the operation needs to be carried out under extracorporeal circulation. The doctor frees the entire aortic arch vessels and then removes them, replaces them with artificial blood vessel 4, and completes end-to-end sutures between the artificial blood vessel and the autologous blood vessel at least at five sites (41 at the ascending aorta, 42 at the innominate artery, 43 at the left common carotid artery, 44 at the left subclavian artery, 45 at the descending aorta). The operation time is about 6 - 10 hours, the average extracorporeal circulation time is 2 - 3 hours, the average aortic cross-clamping time is 1.5 - 2 hours, and the average deep hypothermic circulatory arrest time is 20 - 30 minutes; in short, the operation is complex, takes a long time, has a long learning curve for doctors, and is not easy to promote.

[0007] 2) The long deep hypothermic circulatory arrest time is likely to cause ischemia of organs and lower limbs: The average deep hypothermic circulatory arrest time is 20 - 30 minutes. Circulatory arrest is likely to cause ischemic and hypoxic damage to various organs, and deep hypothermia is likely to lead to pathophysiological changes in various organs.

[0008] 3) The end-to-end suture at each of the above sites is difficult, the anastomosis is prone to bleeding, and there is a lot of bleeding from the serosa junction of the original arch part during dissection; all of the above lead to difficult hemostasis.

[0009] 4) The operation risk is high: The surgical mortality rate abroad is 10% - 33%. [3] The domestic surgical mortality rate is 3.1% - 15.5%, the incidence of acute respiratory insufficiency is 5% - 15%, the incidence of nervous system 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 disease progression are very fast (the mortality rate of type A dissection is 40% to 50% within 48 hours after onset), and the transfer time of patients is long. Therefore, many patients die before they can be treated.

[0010] With the increasing number of global hypertension patients year by year, the prevalence of the above diseases has increased year by year. Due to the above characteristics, many patients cannot obtain timely treatment locally and lose their lives, making this disease a pain point that has troubled clinicians for many years. For more than a decade, doctors around the world have repeatedly tried to use endovascular repair to treat it in order to reduce the above clinical dilemmas. The main methods are as follows:

[0011] 1) In-situ fenestration technique: A straight tubular thoracic aortic covered stent is implanted into the aortic arch region through a catheter. At the corresponding positions of the three branch vessels on the aortic arch, the covering membrane of the thoracic aortic covered stent is perforated in-situ during the operation, and the perforation is dilated with a balloon. Through the dilated perforation, the corresponding branch covered stents are implanted one by one through the catheter. This technique has the following problems: a. Before the covering membrane of the thoracic aortic covered stent is perforated after implantation, the openings of the corresponding branch vessels are isolated by the thoracic aortic covered stent and are in an ischemic state. If the ischemic state lasts for too long, extremely serious brain complications will occur; b. The perforation and fenestration on the thoracic aortic covering membrane are physical tears. Most of the branch covered stents do not fit tightly with the perforation after implantation, and the incidence of endoleak is high (blood flows out from the gap between the perforation on the thoracic aortic covering membrane and the branch covered stent), and the false lumen continues to expand. Patients often need secondary surgical intervention; c. The surgical operation is complex, the operation time is long, and it is not easy to popularize; d. Most of the operations such as perforation and implantation of branch covered stents are performed through the arteries in the neck or the right arm (such as the brachial artery) and the branch vessels on the aortic arch as the access (referred to as the upper access in the interventional field). The instruments move back and forth inside these branch vessels, easily causing the shedding of plaques (mostly with plaques) in these branch vessels, resulting in cerebral infarction during the operation, or causing intimal damage to the branch vessels to form plaques and finally shedding to cause cerebral infarction.

[0012] 2) Embedded tunnel and modular bridging technique: A thoracic aortic covered stent with three internal tunnels is implanted into the aortic arch region through a catheter. These three internal tunnels are used as the interfaces for bridging the thoracic aortic covered stent and the branch covered stents. Among them, the internal 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 internal tunnel corresponding to the left subclavian artery extends from the root of the left subclavian artery to the descending aorta; the catheter is used to implant the branch covered stents corresponding to the innominate artery and the left common carotid artery one by one through the upper access, and through the femoral artery access (referred to as the lower access in the interventional field), the branch covered stent corresponding to the left subclavian artery is implanted. This type of technique also has the following problems: The branch covered stents of the innominate artery and the left common carotid artery are all implanted through the upper access. Not only is the operation time long and the difficulty is high, but many operations are carried out inside the branch vessels of the aortic arch, easily causing the shedding of the original plaques in the branch vessels, resulting in cerebral infarction during the operation, or causing the risk of intimal damage to the branch vessels to form plaques and finally shedding to cause cerebral infarction.

[0013] 3) Hybrid surgery: Hybrid surgery is generally divided into two steps: First, perform a surgical bypass using a prosthetic blood vessel between the innominate artery, the left common carotid artery, and the left subclavian artery from the neck; then, via a catheter, implant a branched interventional covered stent with an innominate artery stent into the innominate artery in the aortic arch region through a lower access. Establish the blood supply between the branched blood vessels at this site. This technique needs to be carried out in two stages, the operation is complex, the patient's waiting time is long, the surgical bypass in the neck may cause corresponding complications, such as bleeding and infection, and this reconstruction method greatly changes the blood flow pattern of the original supra-aortic branches, and the bypassed blood vessels may become stenosed or blocked.

[0014] The above-mentioned various methods have the disadvantages of long operation time, complex operation, various complications, no standards for instruments and surgical methods, and inability to be promoted in most hospitals. Summary of the Invention

[0015] The present invention provides a covered stent system. In one embodiment, the covered stent system includes a) a covered stent, comprising: i) a positioning assembly; ii) a first branched blood vessel fenestration assembly, the first branched blood vessel fenestration assembly including a first sealing zone and a first adjustment zone; the first sealing zone includes a third opening; the first adjustment zone includes a first opening, a second opening, a first reinforcing structure, and a second reinforcing structure; b) a first branched covered stent for being released within the first branched blood vessel fenestration assembly; the first reinforcing structure maintains the first opening, and the second reinforcing structure maintains the second opening; the first adjustment zone is located between the first reinforcing structure and the second reinforcing structure; the first adjustment zone enables the second opening to move relative to the positioning assembly; the first sealing zone extends from the second reinforcing structure to the third opening, such that after the first branched covered stent is released and deployed, it forms a planar sealing connection with the first sealing zone; and the first branched covered stent includes a first connection and anchoring section, the diameter of the first connection and anchoring section after release is greater than the first opening of the first adjustment zone, such that the first connection and anchoring section remains proximal to the first opening of the first adjustment zone.

[0016] The present invention further provides a method for implanting a covered stent into a blood vessel, where 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 the covered stent system of 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 fits against 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; f) releasing the first branch covered stent so that the second opening is aligned with the root of the first branch vessel, the first sealing area is in planar sealing connection with the first branch covered stent, and the first connection and anchoring section remains at the proximal end of the first opening in the first adjustment area. Description of the Drawings

[0017] Figure 1A Schematic diagram showing a normal aorta. Figure 1B Schematic diagram showing an aortic dissection.

[0018] Figure 2 Schematic diagram showing end-to-end suturing of five artificial blood vessels and autologous blood vessels during surgery.

[0019] Figure 3 Front view of the covered stent with a fenestration component.

[0020] Figure 4 Front view of the fenestration component.

[0021] Figure 5 Top view of the fenestration component.

[0022] Figure 6 Front view of the fenestration component.

[0023] Figure 7 Cross-sectional view of the first strengthening structure (second strengthening structure) and the first imaging structure (second imaging structure).

[0024] Figure 8 Schematic diagram showing delivering the covered stent with a fenestration and aligning it with the root of the left common carotid artery and the middle fenestration component (before the covered stent with a fenestration is released and deployed).

[0025] Figure 9 Schematic diagram showing the covered stent with a fenestration after being released and deployed.

[0026] Figure 10 Schematic diagram showing delivering the branch covered stent loaded in the delivery system to the left common carotid artery.

[0027] Figure 11Schematic diagram showing the released and deployed covered stent for the left common carotid artery branch.

[0028] Figure 12 Schematic diagram showing the delivery of the covered stent for the branch vessel loaded in the delivery system to the innominate artery. At this time, there is still a misalignment between the second opening and the root of the branch vessel.

[0029] Figure 13A Schematic diagram showing the misalignment between the second opening and the root of the branch vessel.

[0030] Figure 13B Schematic diagram showing the alignment between the second opening and the root of the branch vessel.

[0031] Figure 14 Schematic diagram showing the released and deployed covered stent for the innominate artery branch. At this time, the second opening is aligned with the root of the branch vessel.

[0032] Figure 15 Schematic diagram showing the released and deployed covered stent for the left subclavian artery branch. At this time, the second opening is aligned with the root of the branch vessel.

[0033] Figure 16 Showing the preoperative clinical CT angiography of clinical trial cases 001 - 010.

[0034] Figure 17 Showing the postoperative clinical CT angiography of clinical trial cases 001 - 010.

[0035] Figure 18 Showing the comparison of the velocity nephogram and streamline diagram between the model with a sealing area and the model without a sealing area in the finite element analysis.

[0036] Figure 19 Showing the comparison of the velocity nephogram between the model with a sealing area and the model without a sealing area in the finite element analysis. Detailed implementation manner

[0037] Diseases involving the main trunk and branch vessels are currently the most serious cardiovascular diseases that endanger the lives of patients and are extremely dangerous. Emergency treatment requires sending the patients to large cardiac centers for extremely invasive surgical operations to obtain treatment. Patients often lose their lives because they cannot receive timely treatment. At the same time, even if they receive timely treatment, the mortality rate of the surgery itself is as high as 10% - 33%, and various postoperative complications are as high as 4% - 30%. This has long been a pain point in the clinical treatment of such patients. The main beneficial effects of the present invention are as follows:

[0038] 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;

[0039] 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;

[0040] 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.

[0041] 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.

[0042] The present invention provides a covered stent system. In one embodiment, the covered stent system comprises a) a covered stent, including: i) a positioning assembly; ii) a first branch vessel fenestration assembly 11, the first branch vessel fenestration assembly 11 including a first sealing zone 111 and a first adjustment zone 112; the first sealing zone 111 including a third opening 1112; the first adjustment zone including a first opening 1121, a second opening 1122, a third opening 1112, a first strengthening structure 113, and a second strengthening structure 114; b) a first branch covered stent for being released within the first branch vessel fenestration assembly 11; the first strengthening structure 113 maintaining the first opening 1121, and the second strengthening structure 114 maintaining the second opening 1122; the first adjustment zone 112 being located between the first strengthening structure 113 and the second strengthening structure 114; the first adjustment zone 112 enabling the second opening 1122 to move relative to the positioning assembly; the first sealing zone 111 extending from the second strengthening structure 114 to the third opening 1112 such that, after the first branch covered stent is released and deployed, a planar sealing connection is formed with the first sealing zone 111; and the first branch covered stent including a first connection and anchoring section, the diameter of the first connection and anchoring section after release being greater than the first opening 1121 of the first adjustment zone, such that the first connection and anchoring section remains at the proximal end of the first opening 1121 of the first adjustment zone.

[0043] In one embodiment, the sealing zone extends from the second strengthening structure to the third opening 1112, and the extension is in a direction from the second strengthening structure towards the adjustment zone.

[0044] In one embodiment, the sealing zone extends from the second strengthening structure to the third opening 1112, and the extension is in another direction from the second strengthening structure towards the adjustment zone.

[0045] In one embodiment, the sealing zone extends from the second strengthening structure to the third opening 1112, and the extension is in both a direction and another direction from the second strengthening structure towards the adjustment zone simultaneously.

[0046] In one embodiment, the first strengthening structure 113 includes a first imaging structure 115; the second strengthening structure 114 includes a second imaging structure 116; or the first adjustment zone 112 includes a third imaging structure 117.

[0047] In one embodiment, the positioning assembly includes a positioning sealing zone and a positioning adjustment zone; the positioning sealing zone includes a positioning third opening; the positioning adjustment zone includes a positioning first opening, a positioning second opening, a positioning first strengthening structure, and a positioning second strengthening structure.

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

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

[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 area 112 or the first sealing area 111 is a flexible cylindrical or frustum-shaped film.

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

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

[0054] In one embodiment, the connection between the first sealing area 111 and the first branch covered stent is a planar connection.

[0055] In one embodiment, the covered stent system further includes a second branch blood vessel fenestration assembly and a second branch covered stent; the second branch blood vessel fenestration assembly includes a second sealing area and a second adjustment area; the second sealing area includes a third opening 1112; the second adjustment area includes a first opening 1121, a second opening 1122, a first strengthening structure 113, and a second strengthening structure 114; the second branch covered stent includes a second connection and anchoring section, and the diameter of the second connection and anchoring section after release is larger than the first opening 1121 of the second adjustment area, so that the second connection and anchoring section remains at the proximal end of the first opening 1121 of the second adjustment area; the positioning assembly is used for implanting into the left common carotid artery; the first branch blood vessel fenestration assembly is used for implanting into the innominate artery; the second branch blood vessel fenestration assembly is used for implanting into the left subclavian artery.

[0056] The present invention further provides a method for implanting a covered stent into a blood vessel, where 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 the covered stent system of the present invention; b) delivering the covered stent into the main trunk of the blood vessel; c) aligning the positioning assembly with the positioning branch vessel; d) releasing the covered stent so that the covered stent fits against 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 covered stent into the first branch vessel through the first branch vessel fenestration assembly 11; f) releasing the first branch covered stent so that the second opening is aligned with the root of the first branch vessel, the first sealing area 111 is in a planar sealing connection with the first branch covered stent, and the first connection anchoring section remains at the proximal end of the first opening 1121 in the first adjustment area.

[0057] In one embodiment, the blood vessel is the aortic arch, and the positioning 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.

[0058] In one embodiment, the blood vessel is the abdominal aorta, and the positioning 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.

[0059] In one embodiment, the blood vessel is the aortic root and the ascending aorta, and the positioning 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 positioning 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 into the positioning blood vessel through the positioning assembly; the positioning assembly includes a positioning sealing area and a positioning adjustment area; the positioning sealing area includes a positioning third opening; the positioning adjustment area includes a positioning first opening, a positioning second opening, a positioning first strengthening structure, and a positioning second strengthening structure; the positioning branch covered stent includes a positioning connection anchoring section, and the diameter of the positioning connection anchoring section after release is greater than the positioning first opening, so that the positioning connection anchoring section remains at the proximal end of the positioning first opening in the positioning adjustment area; ii) releasing the positioning branch covered stent so that the positioning second opening is aligned with the root of the positioning branch vessel, the positioning sealing area and the positioning branch covered stent are in a planar sealing connection, and the first connection anchoring section of the positioning branch covered stent remains at the proximal end of the positioning first opening in the positioning adjustment area.

[0062] The main technical problems to be solved by the present invention are as follows:

[0063] 1) The sealing area of the fenestration component of the present invention is a flexible film structure in the shape of a cylinder or a frustum of a cone. This flexible film structure can ensure the sealing between the fenestration component and the branched covered stent, effectively prevent endoleakage, and solve the problem of endoleakage that may occur after the implantation of the branched covered stent in various fenestration design principles;

[0064] 2) The adjustment area of the fenestration component of the present invention can make the position and angle of the second opening 1122 of the fenestration component movable and adjustable within a certain range to adapt to the anatomical structure differences existing in most main and branch blood vessels;

[0065] 3) The structure of the fenestration component of the present invention does not limit the access position of the branched covered stent system. The branched covered stent can be implanted entirely through the femoral artery (lower access), avoiding the problem of postoperative brain complications caused by the shedding of plaque on the inner wall of the branch blood vessel when entering from the upper access by technologies such as embedded tunnels and modular bridging. It can shorten the operation time, facilitate the operation of doctors and the popularization of the operation;

[0066] 4) The fenestration of the present invention has a strengthening structure. After the covered stent is implanted into the blood vessel, it can isolate the blood vessel wall and the lesion site (false lumen, hematoma, etc.). Even when being compressed in the blood vessel, it can maintain the shape of the fenestration, maintain the blood flow of the branch blood vessel, and solve the problem of cerebral blood supply that may occur in other technologies with only a concave structure; at the same time, it is convenient for the superselection of the guide wire during the operation (superselection means that the catheter or guide wire selectively enters the target branch blood vessel).

[0067] 5) The fenestration component of the present invention has a radiopaque structure. During the delivery process and the superselection process, the position of the fenestration component can be clearly displayed under X-ray, which is convenient for the positioning of the covered stent of the present invention during the operation, the superselection of the guide wire, and the positioning of the branched covered stent during the operation.

[0068] The above characteristics of the present invention are suitable for the repair and reconstruction of anatomical structure differences and lesions (including dissecting aneurysm, true aneurysm, intramural hematoma, multiple penetrating ulcers) existing in most main and branch blood vessels, such as between the aortic arch and the three supra-aortic branch blood vessels as an example above, and between the abdominal aorta and the left and right renal arteries, the superior mesenteric artery, and the celiac trunk artery, etc.

[0069] In an embodiment of the present invention, the cooperation between different components within the covered stent system can effectively prevent the endoleak problem that may occur after the implantation of the branched covered stent. In one embodiment, the connecting and anchoring section of the branched covered stent has a diameter greater than the first opening 1121 of the adjustment region after release and is anchored at the proximal end, which serves as the main means for fixing the branched covered stent. The connecting and anchoring section of the branched covered stent bears most of the force for fixing the branched covered stent, preventing the detachment between the branched covered stent and the fenestration component, thereby preventing the occurrence of type III endoleak. When there is a misalignment between the branched blood vessel structure and the fenestration component, the first reinforcement structure 113 and the second reinforcement structure 114 can maintain the shapes of the first opening 1121 and the second opening 1122, facilitating the superselection of the guide wire; at the same time, the second opening 1122 of the adjustment region can automatically adjust its position when the branched covered stent is released, aligning the second opening 1122 automatically with the root of the branched blood vessel, thereby correcting the misalignment and preventing the kinking of the branched covered stent. After the branched covered stent is released and deployed, the sealing region is a flexible film structure in the shape of a cylinder or a frustum of a cone, and a surface-to-surface seal is formed between this flexible film structure and the branched covered stent, effectively preventing endoleak.

[0070] The present invention relates to a covered stent with a fenestration component for treating vascular diseases involving the main trunk and branched blood vessels. The device described in the present invention is a covered stent with a fenestration component, which is composed of a fenestration component, a columnar covering film 12, and a stent ring 13 (as Figure 3 shown). The fenestration component is composed of a sealing region, an adjustment region, a first opening 1121, a second opening 1122, a third opening 1112, a first reinforcement structure 113, a second reinforcement structure 114, a first radiopaque structure 115, a second radiopaque structure 116, and a third radiopaque structure 117 (as Figure 4 , Figure 5 shown). Among them, the third radiopaque structure 117 is an optional component.

[0071] The covered stent 1 with a fenestration component is used to treat vascular diseases involving the main trunk and branched blood vessels. It is an assembly formed by combining multiple components through a certain process and at least includes one fenestration component.

[0072] The fenestration component is the connection structure between the covered stent 1 with a fenestration and the branched covered stent, and it is an assembly formed by combining multiple components through a certain process.

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

[0074] The stent ring 13 is a wavy or grid-shaped metal wire frame.

[0075] The sealing area is a flexible cylindrical or frustum-shaped film that extends upward and is attached to the second opening 1122 of the adjustment area by means such as stitching or heat melting. The material thereof is a biocompatible material. Optionally, the sealing area extends upward and downward simultaneously from the second opening 1122, as Figure 6 shown.

[0076] The adjustment area is a flexible cylindrical or frustum-shaped film that is attached to the columnar film covering 12 by means such as stitching or heat melting. Its two ends are the first opening 1121 and the second opening 1122, and the material thereof is a biocompatible material.

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

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

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

[0080] The first strengthening structure 113 is a ring-shaped metal attached to the first opening 1121 by means such as stitching or heat melting. The material thereof has superelasticity, such as nickel-titanium alloy, and has a certain degree of imaging effect.

[0081] The second strengthening structure 114 is a ring-shaped metal attached to the second opening 1122 by means such as stitching or heat melting. The material thereof has superelasticity, such as nickel-titanium alloy, and has a certain degree of imaging effect.

[0082] The first imaging structure 115 is a spiral-shaped metal attached to the first strengthening structure 113 by a winding method. The material thereof has a good imaging effect under X-ray, such as platinum alloy, gold. Optionally, the first imaging structure 115 is located at the cross-section center of the first strengthening structure 113, as Figure 7 shown.

[0083] The second imaging structure 116 is a spiral-shaped metal attached to the second strengthening structure 114 by a winding method. The material thereof has a good imaging effect under X-ray, such as platinum alloy, gold. Optionally, the second imaging structure 116 is located at the cross-section center of the second strengthening structure 114, as Figure 7 shown.

[0084] The third imaging structure 117 is a circular or disc-shaped metal attached to the adjustment area by stitching or heat melting. Its material has good imaging effect under X-ray, such as platinum alloy and gold.

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

[0086] The covered stent 1 with a fenestration component is used to treat vascular diseases involving branch vessels, reconstruct the branch vessels while reconstructing the main vessel, and keep the branch vessels unobstructed.

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

[0088] The columnar covering film 12 ensures that blood does not leak out to the outside of the covered stent, and together with the stent ring 13, can play a role in blocking the intimal tear of the blood vessel or blocking the aneurysm cavity.

[0089] The stent ring 13 provides radial support force, enables the columnar covering film 12 to be firmly supported in the main vessel, and supports the expansion of the true lumen of the blood vessel and the reduction of the false lumen.

[0090] The sealing area can ensure the sealing performance between the branch covered stent and the fenestration component, reducing endoleakage.

[0091] The adjustment area enables the second opening 1122 to move and rotate within a certain range to adapt to different branch vessel anatomical structures.

[0092] The first opening 1121, through which blood flows into the adjustment area.

[0093] The second opening 1122, through which blood flows into the sealing area.

[0094] The third opening 1112, through which blood flows out of the sealing area.

[0095] The first strengthening structure 113 maintains the shape of the first opening 1121, keeps the blood flow in the branch vessels unobstructed during and after the operation, and is convenient for superselective catheterization during the operation.

[0096] The second strengthening structure 114 maintains the shape of the second opening 1122, keeps the blood flow in the branch vessels unobstructed during and after the operation, and is convenient for superselective catheterization during the operation.

[0097] The first imaging structure 115 makes the shape of the first opening 1121 more obvious under intraoperative X-ray, thus facilitating the intraoperative positioning of the covered stent 1 with a fenestration component, the superselective catheterization of the branch, 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-rays, thus facilitating the intraoperative positioning of the covered stent 1 with a fenestrated component, the super-selective catheterization of branches, and the positioning of the branched covered stent.

[0099] The third imaging structure 117 makes the position of the fenestrated component more obvious under intraoperative X-rays, thus facilitating the intraoperative positioning of the covered stent 1 with a fenestrated component, the super-selective catheterization of branches, and the positioning of the branched covered stent.

[0100] Description of the surgical steps:

[0101] In the present invention, the surgery for treating vascular diseases where the lesions involve the main trunk and branch vessels can be simplified into the following five steps. Here, for the convenience of description, the aortic arch region is selected as the region to be reconstructed:

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

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

[0104] iii. As Figure 10 shown, the branched covered stent 2 is loaded in the delivery system. By aligning the imaging structure (the first imaging structure 115) in the middle fenestrated component with the imaging structure (the first stent at the end close to the heart) on the branched covered stent, the delivery system is delivered to the designated position.

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

[0106] v. As Figure 12 shown, the branched covered stent is loaded in the delivery system. By aligning the imaging structure (the first imaging structure 115) in the leftmost fenestrated component in the figure with the imaging structure (the first stent at the end close to the heart) on the branched covered stent, the delivery system is delivered to the designated position. As Figure 13A and Figure 13BAs shown, when there is a misalignment between the second opening 1122 in the windowing component on the far left in the figure and the root of the innominate artery 321, since the adjustment area in the windowing component allows the second opening 1122 to move and rotate within a certain range, when operating the guide wire for super-selective access, pushing the branched covered stent system, and releasing the branched covered stent, the second opening 1122 can adjust its position and angle to align with the root of the innominate artery 321.

[0107] vi. As Figure 14 As shown, release the branched covered stent of the innominate artery. At this time, one end of the branched covered stent close to the heart fits against the sealing area of the windowing component of the covered stent 1 with a window, and the end far from the heart fits against the inner wall of the branched blood vessel.

[0108] vii. As Figure 15 As shown, repeat step v and step vi to implant the branched covered stent of the left subclavian artery and complete the vascular reconstruction in the aortic arch region.

[0109] For the endovascular treatment of vascular diseases involving the main trunk and branched blood vessels, techniques such as in-situ windowing technique, embedded tunnel, and modular bridging technique face the biggest problems such as differences in the anatomical structure of branched blood vessels, endoleak, the need to implant the branched covered stent from the distal end of the branch, complex operation, long operation time, etc. In view of the above problems, this case has the following innovative points:

[0110] 1) The sealing area of the windowing component can ensure the sealing between the windowing component and the branched covered stent, effectively preventing endoleak. The sealing area belongs to surface leak prevention, and its leak prevention effect is far better than that of linear leak prevention. In one embodiment, the sealing area is a cylindrical or frustum-shaped flexible membrane structure.

[0111] 2) The opening position and angle of the windowing component of the present invention can be adjusted within a certain range, which can adapt to the anatomical structure differences of most branched blood vessels due to individual differences. In addition, the specifications of the covered stent 1 with a windowing component can be greatly reduced, thereby reducing the difficulty of its design and production and reducing the stock quantity. In one embodiment, the adjustment area of the windowing component can adjust the position and angle of the second opening 1122 within a certain range, which can adapt to the anatomical structure differences of most branched blood vessels.

[0112] 3) The structure of the windowing component does not limit the access position of the branched covered stent system, and the access position of the branched covered stent system can be selected according to the actual situation of the patient's blood vessels, that is, the branched covered stent system can all enter from the femoral artery (lower access). The branched covered stent system entering entirely from the lower access is the first choice, which is not only much more convenient to operate than the upper access, can reduce the postoperative brain complications caused by the shedding of plaque on the inner wall of the branched blood vessel that may be caused by entering through the upper access, and can also greatly reduce the operation time;

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

[0114] 5) The fenestration component has a first imaging structure 115, a second imaging structure 116, and a third imaging structure 117. During the delivery process and the superselection process, the position of the fenestration can be clearly shown under X-ray, which is convenient for the positioning of the covered stent 1 with fenestration, the superselection of the guide wire, and the positioning of the branch covered stent during the operation; thus improving the success rate of the operation.

[0115] 1) Clinical CTA:

[0116] Using the covered stent system manufactured by the technology of the present invention, 10 cases of clinical trials were carried out. The postoperative CTA showed that there was no endoleak between the branch covered stent and the fenestration component, the branch covered stent was in good alignment. The shortest operation time was only 61 minutes, and the average was only 112 minutes. The preoperative and postoperative CTAs are respectively as Figure 16 、 Figure 17 shown.

[0117] 2) Finite element analysis:

[0118] Through finite element analysis, for the model without a sealing area, there is endoleak between the fenestration component and the branch covered stent. For the model with a sealing area, there is no endoleak in the same place. Specifically as Figure 18 、 Figure 19 shown. Figure 18 The velocity contour and streamline diagram are shown. The left figure is the model without a sealing area, and the streamline between the fenestration component and the branch covered stent is regular and there is endoleak. The right figure is the model with a sealing area, and the flow between the fenestration component and the branch covered stent is a vortex and there is no endoleak. Figure 19 The velocity contour is shown. The left figure is the model without a sealing area, and the flow velocity between the fenestration component and the branch covered stent is greater than 0.05 m / s and there is endoleak. The right figure is the model with a sealing area, and the flow velocity between the fenestration component and the branch covered stent is 0 and there is no endoleak.

Claims

1. A covered stent system, comprising: 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 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 strengthening structure, and a second strengthening structure; b. A first branch covered stent for being released within the first branch vessel fenestration component; Characterized in that: The first strengthening structure maintains the shape of the first opening, and the second strengthening structure maintains the shape of the second opening; The first adjustment area is located between the first strengthening structure and the second strengthening structure; The first adjustment area is a flexible cylindrical or frustum-shaped film, and allows the second opening to move and rotate relative to the positioning component within a certain range to adapt to the anatomical structure differences of the branch vessels; The first sealing area extends from the second strengthening structure to the third opening to form a flexible cylindrical or frustum-shaped film, so that the connection between the first branch covered stent during release and the first sealing area is a planar connection to form a planar sealing connection; and The first branch covered stent includes a first connection and anchoring section, the first connection and anchoring section includes a flange stent and a flange covering film, and the diameter of the first connection and anchoring section after release is greater than the first opening of the first adjustment area so that the first connection and anchoring section remains at the proximal end of the first opening of the first adjustment area.

2. The covered stent system according to claim 1, wherein: The sealing area extends from the second strengthening structure to the third opening, and the extension is from the second strengthening structure towards the adjustment area.

3. The covered stent system according to claim 1, wherein: The sealing area extends from the second strengthening structure to the third opening, and the extension is from the second strengthening structure towards the other direction of the adjustment area.

4. The covered stent system according to claim 1, wherein: The sealing area extends from the second strengthening structure to the third opening, and the extension is from the second strengthening structure towards the direction and the other direction of the adjustment area simultaneously.

5. The covered stent system according to claim 1, characterized in that: The first strengthening structure includes a first radiopaque structure; The second strengthening structure includes a second radiopaque structure; or The first adjustment area includes a third radiopaque structure.

6. The covered stent system according to claim 1, wherein: The positioning component includes a positioning sealing area and a positioning adjustment area; the positioning sealing area includes a positioning third opening; the positioning adjustment area includes a positioning first opening, a positioning second opening, a positioning first strengthening structure, and a positioning second strengthening structure.

7. The covered stent system according to claim 6, wherein: The covered stent further includes a positioning branch covered stent for being implanted into the positioning component.

8. The covered stent system according to claim 1, wherein: The relative sizes of the first opening, the second opening, and the third opening are selected from one or more of the following: a. The first opening is greater than or equal to the second opening; b. The second opening is greater than or equal to the third opening.

9. The covered stent system according to claim 1, characterized in that: The shape of the first opening, the second opening, or the third opening is circular or similar to circular.

10. The covered stent system according to claim 1, wherein: The first strengthening structure or the second strengthening structure is made of a superelastic material.

11. 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 region and a second adjustment region; the second sealing region includes a third opening; the second adjustment region includes a first opening, a second opening, a first strengthening structure, and a second strengthening structure; The second branch covered stent includes a second connecting and anchoring section, and the diameter of the second connecting and anchoring section after release is greater than that of the first opening of the second adjustment region so that the second connecting and anchoring section remains outside 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 innominate artery; the second branch vessel fenestration assembly is used for implantation into the left subclavian artery.

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