Branch artery reconstruction auxiliary device and SC branch-priority aortic reconstruction system

Abstract

Provided are a branch artery reconstruction assist device and an SC branch-preferential aortic reconstruction system, the branch artery reconstruction assist device comprising a first stent body (20a), the first stent body (20a) comprising a bare stent portion (23a), and a cardiac proximal covered stent portion (21a) and a cardiac distal covered stent portion (22a) connected to both sides of the bare stent portion (23a), and a sealing membrane (219a, 229a) and at least one sealing membrane (229a) are provided inside both the cardiac proximal covered stent portion (21a) and the cardiac distal covered stent portion (22a). Two coated stents (211a, 212a, 221a) are provided, and the sealing membranes (219a, 229a) include first openings (213, 214, 222), which are connected to corresponding first ends of the coated stents (211a, 212a, 221a), and the second ends of the coated stents (211a, 212a, 221a) are connected to corresponding branch artery coated stents (216, 217, 218) to form branch channels, and pass through the bare stent portion (23a). The SC branch-priority aortic reconstruction system includes a branch artery reconstruction assist device and a second stent body (50a), and the second stent body (50a) and the first stent body (20a) cooperate to seal and isolate the lesion. This prevents end leaks from the stent, ensures smooth access to each artery, and ensures normal blood flow to the brain and / or organs during surgery, avoids blood flow blockage, and reduces ischemic complications.

Description

[Technical Field]

[0001] The present application relates to the technical field of medical devices, and in particular to a branch artery reconstruction assist device and an SC branch-preferential aortic reconstruction system. [Background technology]

[0002] The aorta, the largest and thickest arterial vessel in the human body, is the main blood vessel carrying blood to various parts of the body. It begins in the left ventricle of the heart, arches slightly upward, to the right, and downward, then descends along the spinal column and branches into many smaller arteries within the thoracic and abdominal cavities. The aorta primarily comprises the ascending aorta, the aortic arch, and the thoracic-abdominal aorta (the aorta extends from the left subclavian artery to above the iliac arteries on both sides; the aortic portion above the diaphragm is called the descending thoracic aorta, and the aortic portion below the diaphragm is called the abdominal aorta). Serious and dangerous aortic lesions primarily include aortic aneurysms and aortic dissections. Clinically, aortic arch lesions (mainly aortic aneurysms or aortic dissections) have traditionally posed significant challenges in the treatment of vascular diseases, resulting in extremely high non-surgical mortality rates. However, current treatment methods have many problems, including occasional death, paralysis, cerebral embolism, and acute renal failure. Surgical treatment requires multiple anastomotic ports, making the anastomosis more difficult, and can lead to intraoperative bleeding, deep hypothermia, circulatory arrest, and a series of serious complications.

[0003] With the rapid development of thoracic aortic endovascular repair (TEVAR) techniques and devices, the indications for TEVAR have expanded from descending aortic lesions to aortic arch lesions. However, aortic arch disease has been considered a forbidden area for endovascular intervention due to its complex anatomical structure. The main difficulty lies in how to ensure isolation of the aortic arch lesion while maintaining patency of the branch vessels in the arch. Currently, numerous off-label devices are used for interventional treatment. Various endovascular aortic reconstruction techniques have been tried, including fenestrated stents, customized stents, chimney techniques, "skirt stents" specifically designed for chimney techniques, and modular branch artery capped stent-based endovascular reconstruction. However, issues such as intraoperative blood flow blockage and long-term patency rates of branch artery capped stents remain unsatisfactory, and there is currently no mature endovascular treatment product widely available for clinical use.

[0004] Currently, in clinical practice, the "chimney" and "fenestration" techniques are mainly used to assist in endovascular treatment of aortic arch aneurysms and aortic arch dissections. However, common challenges include endoleaks and mismatches between the main and branch artery capsular stents, which pose significant challenges to clinical treatment. Potential risks such as endoleaks and stent migration remain unresolved.

[0005] To address the issues of endoleaks and long-term patency of branch artery covered stents in the chimney technique, the inventors developed the aortic arch stent system (fenestrated type) and the CSkirt aortic arch branch artery covered stent system (fenestrated skirt stent) based on deep insight into clinical needs. The aortic arch stent is punctured through the aortic arch main body stent via the aortic arch stent membrane rupture system to create a puncture point. The puncture point is then expanded with a balloon to create a "window" for blood flow. The CSkirt aortic arch branch artery covered stent (fenestrated skirt stent) is then inserted along a guidewire, passed through the "window," and released. However, with use, it was discovered that this structure had some problems, such as complicated operation.

[0006] On the other hand, aortic diseases involving visceral artery branches (visceral artery branches mainly refer to the renal arteries, celiac artery, and superior mesenteric artery) mainly include thoracoabdominal aortic aneurysm (TAAA), aortic dissection (AD), and abdominal aortic aneurysm (AAA). A common feature of lesions such as thoracoabdominal aortic aneurysm, some aortic dissections, and abdominal aortic aneurysm is that the lesions involve visceral artery branches or may touch the area of ​​these visceral artery branches during the course of treatment.

[0007] Taking thoracic abdominal aortic aneurysm as an example, it refers to an aneurysmal dilatation disease involving both the thoracic aorta and the abdominal aorta at the same time, and the extent of the lesion is complex and widespread, generally involving important visceral blood vessels such as the intercostal arteries, celiac trunk, superior mesenteric artery, and both renal arteries.

[0008] Conventional endovascular aneurysm repair (EVAR) remains challenging for the treatment of pararenal abdominal aortic aneurysms, thoracoabdominal aortic aneurysms involving abdominal aortic branch vessels, and aortic dissections. The main obstacle is how to restore the blood supply to the visceral arteries. Aortic disease involving visceral artery branches cannot be treated with a simple covered stent due to the relationship between visceral artery perfusion and blood supply. Endovascular repair techniques restore the blood supply to visceral artery branches, reduce the large wounds required for open surgery, and play an important role in the treatment of aortic disease involving visceral artery branches. The endovascular repair techniques used mainly include the chimney technique, sandwich technique, fenestration technique, and multi-branch technique. Specifically, chimney stents were first used as a treatment for cases in which a stent-type graft unintentionally covered a branch vessel. Currently, they are primarily used in patients with pararenal abdominal aortic aneurysms whose constitutional conditions make them unsuitable for open surgery and whose anatomical conditions make them unsuitable for fenestration or multibranch techniques. Because chimney stents are positioned between the stent-type graft and the native arterial wall, the incidence of endoleaks is relatively high. Meanwhile, the sandwich technique has shown good short-term results, but its long-term stability and effectiveness remain to be verified. The fenestration technique has strict requirements for the anatomical conditions of the patient's aneurysm, and an aneurysm neck with an excessively large torsion angle can affect the accurate alignment of the fenestration and the target vessel. Similar to the fenestration technique, the multibranch technique is currently used in only a small number of patients due to its complex operation, high cost, and the need for individual customization.

[0009] Currently, the main methods for treating TAAA include open surgery and hybrid surgery. Both open surgery and hybrid surgery require laparotomy, which results in large wounds and complicated visceral artery reconstruction, and the risks of intraoperative massive bleeding, shock, cardiac arrest, and multiple organ failure remain. Summary of the Invention [Problem to be solved by the invention]

[0010] In view of the above, the object of the present application is to propose a branch artery reconstruction assist device and a branch-priority aortic reconstruction system in order to solve the problem of serious complications caused by endoleaks, arterial ischemia, etc., which cannot be avoided with conventional techniques. [Means for solving the problem]

[0011] In accordance with the above object, the present application provides a branch artery reconstruction assist device, the branch artery reconstruction assist device comprising a first stent body, the first stent body comprising a bare stent portion and a proximal- and distal-side covered stent portion connected to either side of the bare stent portion, a sealing membrane and at least one first covered stent channel provided inside each of the proximal- and distal-side covered stent portions, the sealing membrane including first openings connected to corresponding first ends of the first covered stent channels, and second ends of the first covered stent channels connected to corresponding branch artery covered stents to form branch channels, the sealing membrane passing through the bare stent, wherein the number of first openings is the same as the number of first covered stent channels. The plurality of first openings are provided in one-to-one correspondence with the plurality of first coated stent channels, respectively, thereby realizing the reconstruction of each of the blood flow channels in the corresponding branch arteries.

[0012] The first coated stent channel here may be formed by a corresponding coated embedded stent, or may be any other structure in the prior art that can individually connect the aorta and its branch arteries. Here, the coated embedded stent may include an embedded stent body having a cavity and a coating provided on the outside of the embedded stent body. That is, the first coated stent channel is formed by the cavity of the corresponding coated embedded stent. Here, the bare stent portion is a stent without a coating.

[0013] Here, the cross section of the first coated stent channel is circular or elliptical, and thus the first coated stent channel matches the shape of the branch artery or branch artery coated stent, and when it is in close contact with them, there are no gaps and blood does not leak.

[0014] When there are a plurality of first coated stent channels provided inside the proximal or distal covered stent section, the first coated stent channels are arranged parallel to one another. Specifically, the number of first coated stent channels in the proximal covered stent section may be 0, 1, 2, 3, etc., and the number of first coated stent channels in the distal covered stent section may also be 0, 1, 2, 3, etc. The number of first coated stent channels is determined according to the placement location of the stent and the physician's usage habits, and the total number of first coated stents within the first stent body should also match the number of branch arterial pathways requiring reconstruction.

[0015] Preferably, the distance between the inlet end of the branch artery corresponding to the proximal covered stent portion and the inlet end of the branch artery corresponding to the distal covered stent portion is shorter than the length of the bare stent.

[0016] Preferably, the bare stent has a bendable structure.

[0017] In this case, a branch artery covered stent is provided in the branch artery, and the branch artery covered stent communicates with the first covered stent channel to form a blood flow channel, part of which is located within the bare stent portion and part of which is located outside the bare stent portion. At any one location within the first covered stent channel, there is an overlapping region nested on the proximal side of the corresponding branch artery covered stent. In this way, the first covered stent channel is nested and overlapped with the corresponding branch artery covered stent, forming a corresponding branch channel. This improves the stability of the branch artery vascular pathway, more completely reconstructs the arterial branch, and prevents blood leakage.

[0018] In the overlapping region, the branch artery covered stent and the corresponding first covered stent channel abut against each other, with no gaps between the abutting surfaces, thereby preventing blood leakage and preventing the branch artery covered stent from falling off. The length of the overlapping region is set to be greater than a predetermined size to ensure a sufficient contact surface between the first covered stent channel and the branch artery covered stent, thereby preventing blood leakage, increasing the resistance of the branch artery covered stent to blood flow impact, and improving the stability of the branch artery covered stent. For example, the predetermined size may be any length that improves the connection stability between the first covered stent channel and the corresponding branch artery covered stent. Of course, the branch artery covered stent may also be provided with barbs for fastening to the inner wall of the first covered stent channel to prevent it from falling off due to blood flow impact.

[0019] Preferably, when the connection position between the heart proximal side covered stent portion or the heart distal side covered stent portion and the sealing membrane is flush with the first end of the first covered stent channel, the sealing membrane has a flat shape, and / or when the connection position between the heart proximal side covered stent portion or the heart distal side covered stent portion and the sealing membrane is not flush with the first end of the first covered stent channel, the sealing membrane has a sloped shape.

[0020] That is, the end of the first covered stent channel away from the branch artery may or may not be flush with the end point of the proximal or distal covered stent portion away from the bare stent portion, and the sealing membrane may or may not be perpendicular to the coating direction of the first or distal covered stent portion. It should be emphasized that the beveled design contributes to blood flow entering the first covered stent channel, but the flat design does not prevent blood flow from entering the first covered stent channel.

[0021] Preferably, the sealing membrane in the proximal covered stent section is connected to the proximal end of the proximal covered stent section, and the sealing membrane in the distal covered stent section is connected to the distal end of the distal covered stent section, wherein the sealing membranes can be provided at the proximal end of the proximal covered stent section and the distal end of the distal covered stent section.

[0022] Preferably, a first positioning stent is provided at the proximal end of the proximal covered stent section and / or the distal end of the distal covered stent section. Specifically, the first positioning stent is generally provided at a position on the proximal side of the first stent body. That is, when the proximal covered stent section is located on the proximal side, the first positioning stent is provided at a first end of the proximal covered stent section, and when the distal covered stent section is located on the proximal side, the first positioning stent is provided at a second end of the distal covered stent section. When delivering the first stent body, a stent delivery device is connected to the first positioning stent, and the first stent body is delivered to the target position.

[0023] Here, the end of the cardiac proximal covered stent portion or the cardiac remote covered stent portion connected to the first positioning stent is parallel to the surface of the positioning stent. Furthermore, the first positioning stent may be a bare stent, the tip of which is designed to retract inward so as not to pierce the aortic wall, and is used primarily to release the first stent body inside the body. Here, the first positioning stent may be provided with barbs to prevent the first stent body from slipping when impacted by blood flow in the aorta. Similarly, barbs may be provided at the first end of the cardiac proximal covered stent portion or the second end of the cardiac remote covered stent portion.

[0024] Preferably, the sealing membrane further includes a second opening, and the second opening of the sealing membrane in the near-heart covered stent portion and the second opening of the sealing membrane in the far-heart covered stent portion are in communication with each other via the aortic channel.

[0025] Preferably, the first opening is provided on one side of the sealing membrane, and the second opening is provided on the other side of the sealing membrane.

[0026] Preferably, the second opening is provided at a central position of the sealing membrane, and the first openings are provided on both sides of the second opening.

[0027] Preferably, an extension stage is provided at the heart-remote end of the heart-remote covered stent portion, and two parallel second covered stent channels are provided within the extension stage, one portion of the second covered stent channel is provided within the extension stage, and the other portion extends outside the extension stage to communicate with the corresponding branch artery covered stent, and the two second covered stent channels fill the extension stage. When the present application is applied to a patient whose aortic lesion extends to the abdominal aorta region, it is necessary to simultaneously complete the connection between the first stent body and the common iliac artery. Therefore, in the present application, at least one second coated stent channel is provided within the covered stent portion proximal to the heart or the covered stent portion distal to the heart, and a portion of the second coated stent channel is provided within the covered stent portion proximal to the heart or the covered stent portion distal to the heart, and the remainder extends outside the end of the covered stent portion proximal to the heart or the covered stent portion distal to the bare stent portion, and communicates with the corresponding artery (e.g., the iliac artery).

[0028] Preferably, the cross section of the two second coated stent channels is double-D shaped.

[0029] When a branch artery channel is reconstructed using the above-described branch artery reconstruction assist device, blood can flow freely in and out of the first stent body through the second opening in addition to flowing into the branch artery through the first opening, and at this time, the aortic lesion is not isolated from the blood flow, and blood can also freely flow out of the first stent body. In other words, with the branch artery reconstruction assist device of the present application, in the case of branch artery-first aortic reconstruction, blood can flow from the upstream of the aorta through the first stent body to the downstream of the aorta, so there is no risk of the body becoming ischemic, and blood in the artery is not isolated from the lesion site.

[0030] The present application also provides an SC branch-priority aortic reconstruction system, comprising any of the branch artery reconstruction assist devices described above and a second stent body, wherein the second stent body is a covered stent for forming an aortic channel, and is disposed within the first stent body after the positioned release of the first stent body is completed and the branch artery reconstruction is completed. The second stent body is used to form the aortic channel, thereby connecting blood flow within the aorta while isolating the lesion site. During the branch artery reconstruction process, blood flows through a sealing membrane at the end of the first stent body facing the blood through a first opening, enters the first covered stent channel, and then passes through the corresponding branch artery covered stent to enter the branch artery where the branch artery covered stent is located. At the same time, blood flows in and out of the first stent body (which does not isolate the lesion site) through the second opening. It should be understood that the first coated stent channel may be inserted into the first opening, and the insertion position relative to the first opening may be any position (e.g., at either of the two ends in the extension (i.e., longitudinal) direction of the first coated stent channel, or any position between the two ends).

[0031] Preferably, both sides of the second stent body communicate with the second opening in the sealing membrane in the proximal covered stent section and the second opening in the sealing membrane in the distal covered stent section, respectively.

[0032] Preferably, a leak prevention channel is provided in the proximal covered stent portion and / or the distal covered stent portion, and one end of the leak prevention channel is connected to the second opening and the other end is connected to a corresponding end of the second stent body. Specifically, one end of the leak prevention channel is connected to the second opening and the other end of the leak prevention channel is connected to the second stent body. A nested connection is preferred for the connection between the leak prevention channel and the second stent body, i.e., the leak prevention channel and the second stent body are connected so that their connecting portions overlap. After the branch artery pathway is reconstructed using the first coated stent channel, a second stent body is placed inside the first stent body, and both sides of the second stent body are connected to the anti-leak channels. Blood flows from the anti-leak channel at one end of the first stent body to the second stent body, then to the other end of the first stent body, and finally flows out of the first stent body. At this time, the branch-preferential aortic reconstruction system of the present application successfully reconstructs the aortic pathway of the body, and at this time, blood flow is isolated from the diseased part in the branch artery region, and can flow from the upstream aorta through the first coated stent channel to the branch artery and through the second stent body to the downstream aorta.

[0033] Preferably, a second positioning stent is provided at the end of the second stent body, and the second stent body is connected to the end of the leak prevention channel by the second positioning stent. The provision of barbs on one or both ends of the second stent body to facilitate anchoring of the second stent body within the first stent body can be understood as a first barb being provided on the proximal side of the second stent body, thereby engaging the second stent body with the first stent body. Alternatively, a second barb may also be provided on the distal side of the second stent body, or a first barb may be provided only on the proximal side of the second stent body. This allows the second stent body to be fixed to the inner wall of the leak prevention channel of the first stent body in the blood vessel while being impacted by the high-speed, high-pressure blood flow in the aorta. Here, like the first stent body, a positioning stent is also provided at one end of the second stent body, connected to a stent delivery device, to facilitate delivery of the second stent body to a predetermined position. Here, the diameter of the second stent body after release is set to be equal to or larger than the inner diameter of the leak prevention channel in order to improve the sealing between the second stent body and the leak prevention channel.

[0034] Preferably, the device further comprises a branch artery covered stent connected to the first covered stent channel and / or the second covered stent channel.

[0035] When the first stent body and the second stent body are used in conjunction with each other, the first stent body may have a positioning mark only, or the second stent body may have a positioning mark only, or both the first stent body and the second stent body may have a positioning mark. The positioning mark is used for positioning under X-rays and helps to determine the position of the stent during surgery. The positioning mark may be provided at any position on the first stent body, for example, on the distal side of the heart. The positioning mark may be provided at all positions on the first stent body. Similarly, the positioning mark may be provided at any position on the second stent body, for example, on the distal side of the heart. The positioning mark may be provided at all positions on the second stent body.

[0036] Preferably, the diameter of the branch artery covered stent is gradually changed. Preferably, the diameter of the end of the branch artery covered stent connected to the first or second covered stent channel is smaller than the diameter of the other end, or the diameter of the end of the branch artery covered stent connected to the first or second covered stent channel is larger than the diameter of the other end. Note that the gradual change in diameter is not limited to the above cases and may be in accordance with specific clinical needs.

[0037] As can be seen from the above, the branch artery reconstruction assist device of the present application can complete the branch-first reconstruction step by placing a first stent body in the body when blood in the aorta is not blocked. On the other hand, the SC branch-first aortic reconstruction system uses a combination of a first stent body and a second stent body. First, the first stent body is placed in the aorta, and an aortic-branch blood flow channel is constructed by both the embedded stent and the branch artery-covered stent placed in the branch artery, thereby performing the branch reconstruction-first step (branch artery-first reconstruction) to treat multi-branch aortic disease. After the branch artery pathway is reconstructed, the second stent body is inserted into the leak-proof channel of the first stent body, and both of them form an aorta-aorta blood flow channel. The sealing cooperation between the second stent body and the first stent body isolates the lesion, so that the stent does not leak end-over-end, each artery remains patent, and cerebral and / or organ blood flow is normally supplied during surgery, avoiding blood flow blockage and reducing ischemic complications. [Effects of the Invention]

[0038] Compared with the prior art, the present invention has the following advantages:

[0039] 1. The present invention can be used to isolate aortic dissection or aneurysm cavities and avoid endoleaks.

[0040] 2. The intraoperative branch reconstruction and isolation of the lesion are divided into two steps: first, a first stent is used to establish blood flow in the three-branch aortic arch or four-branch visceral artery branches of the thoracoabdominal aorta, and then a second stent is implanted to isolate the lesion in the aortic arch or thoracoabdominal aorta, thereby solving the problem of maintaining blood flow and avoiding ischemia during branch vessel reconstruction surgery.

[0041] 3. The present invention establishes a branch channel in an ischemic-free, open state, avoiding the complicated steps of pre-opening a window on a coated stent or opening a window in situ after implantation in the prior art, and also avoiding organ ischemia caused by prolonged surgery. [Brief explanation of the drawings]

[0042] In order to more clearly explain the technical solutions in the present application or related art, the following briefly introduces drawings necessary for describing the embodiments or related art. However, the drawings in the following description are only embodiments of the present application, and it is obvious to those skilled in the art that other drawings can be obtained based on these drawings without any creative efforts.

[0043] [Figure 1a] FIG. 1 is a structural schematic diagram of a first stent body before use in an SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application. [Figure 1b] FIG. 2 is a structural schematic diagram of a second stent body before use in an SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application. [Figure 2] FIG. 1 is a structural schematic diagram showing the combined use of a first stent body and a second stent body in an SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application. [Figure 3] FIG. 1 is a structural schematic diagram of a first stent body in an SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application when the first stent body is placed in the aortic arch. [Figure 4a]1 is a cross-sectional schematic diagram of a first coated stent portion of a first stent body in an SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application. [Figure 4b] FIG. 2 is a partial schematic diagram of the cardiac proximal side of the first coated stent portion of the first stent body in the SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application. [Figure 5a] FIG. 2 is a cross-sectional schematic diagram of a second coated stent portion of a first stent body in an SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application. [Figure 5b] FIG. 2 is a partial schematic diagram of the distal heart side of the second coated stent portion of the first stent body in the SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application. [Figure 6] FIG. 10 is a schematic diagram of the structure of the distal side of the heart after the first stent body and the second stent body are used in combination in an SC branch-preferential aortic arch reconstruction system according to an embodiment of the present application. [Figure 7a] FIG. 1 is a structural schematic diagram of a first type of first stent body in an SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application before use. [Figure 7b] FIG. 2 is a structural schematic diagram of a second stent body before use in an SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application. [Figure 7c] FIG. 1 is a schematic diagram of the second type of first stent body before use in the SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application. [Figure 7d] FIG. 1 is a schematic diagram of the first stent body of the third type in the SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application before use. [Figure 8a] FIG. 1 is a structural schematic diagram of a first type of first stent body in an SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application when the first stent body is placed in the thoracic and abdominal aorta. [Figure 8b] FIG. 1 is a structural schematic diagram when a first stent body and a second stent body of one type are used in combination in an SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application. [Figure 8c]FIG. 1 is a structural schematic diagram of a second type of first stent body in an SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application when the first stent body is placed in the thoracic and abdominal aorta. [Figure 8d] FIG. 1 is a structural schematic diagram when two types of first and second stent bodies are used in combination in an SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application. [Figure 8e] FIG. 1 is a structural schematic diagram of a third type of first stent body in an SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application when it is placed in the thoracic and abdominal aorta. [Figure 8f] FIG. 1 is a structural schematic diagram of the SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application, when three types of first and second stent bodies are used in combination. [Figure 9a] FIG. 2 is a schematic diagram of the structure of the cardiac proximal side of a first type of first stent body in the SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application. [Figure 9b] FIG. 9b is a cross-sectional schematic diagram of FIG. 9a. [Figure 10a] FIG. 2 is a schematic diagram of the structure of the distal side of the first stent body of the first type in the SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application. [Figure 10b] FIG. 10b is a cross-sectional schematic diagram of FIG. 10a. [Figure 11a] FIG. 10 is another schematic diagram of the structure of the second coated stent portion on the distal side of the heart in the SC branch-preferential thoracic and abdominal aortic reconstruction system according to an embodiment of the present application. [Figure 11b] FIG. 11b is a cross-sectional view of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0044] To make the objectives, technical solutions and advantages of the present application clearer, the present application will be described in more detail below with reference to specific embodiments and drawings.

[0045] Unless otherwise defined, technical or scientific terms used in the examples of this application should have the ordinary meaning understood by those skilled in the art. The terms "first," "second," and similar terms used in the examples of this application do not denote any order, quantity, or importance, but are used only to distinguish different components. Similar terms such as "comprise" or "comprises" mean that the element or item appearing before the term includes the element or item listed thereafter and its equivalents, and does not exclude other elements or items. Similar terms such as "connected" or "coupled" are not limited to physical or mechanical connections, but may include direct or indirect electrical connections. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positions, and if the absolute position of the described object changes, this relative position may also change accordingly.

[0046] Furthermore, the numerical values ​​described in the examples of the present application are merely examples and do not limit the technical features of the present application.

[0047] Endovascular treatments utilize implantable covered stents (e.g., fenestrated stent implantation, branch artery covered stent implantation, chimney technique, etc.) to achieve minimally invasive repair without opening the chest or blocking blood flow. However, treatment requires isolating the lesion while keeping the vessel open, which makes the procedure extremely difficult. Therefore, the SC branch-first aortic reconstruction system of the present application can achieve isolating the lesion while keeping the vessel open. Specifically, the system includes a branch artery reconstruction assist device and a second stent body, where the branch artery reconstruction assist device includes a first stent body. It should be understood that in a "branch-first" aortic and branch artery reconstruction procedure, the branch artery pathway must first be reconstructed using the branch artery reconstruction assist device. After the branch artery pathway is reconstructed, the aortic pathway is reconstructed using a second stent body, if necessary.

[0048] In the examples of the present application, the SC branch-priority aortic reconstruction system is described in detail using examples of its use in the aortic arch and some lesions of the distal ascending aorta or thoracoabdominal aorta. However, the present application is not limited to use in the aortic arch and thoracoabdominal aorta. When used in other aortic lesions, the technical effect of preventing endoleak and ischemia can still be achieved by adjusting the positions and numbers of the first covered stent channels in the proximal-heart covered stent portion (corresponding to the first covered stent portion) and distal-heart covered stent portion (corresponding to the second covered stent portion) according to the positions and number of branch arteries. In the present application, the proximal-heart side can be understood as the end closer to the heart (e.g., the direction of blood inflow shown in Figures 2a to 2c), and the distal-heart side can be understood as the end relatively farther from the heart (e.g., the direction of blood outflow shown in Figures 2a to 2c).

[0049] In some embodiments, the SC branch-preferential aortic reconstruction system according to the present application is an SC branch-preferential aortic arch reconstruction system, in which the aorta is the aortic arch and its branch arteries are the innominate artery, the common carotid artery, and the subclavian artery. It should be understood that the first stent body 20a and the second stent body 50a are separated before reconstructing the aortic pathway, as shown in Figures 1a and 1b, whereas the first stent body 20a and the second stent body 50a are used in conjunction with each other when reconstructing the aorta, as shown in Figures 2 and 3. When implanted in the aortic arch, both the first stent body 20a and the second stent body 50a straddle the aortic arch in a saddle-like manner, and the stability of this combination is much higher than that of other branch artery covered stent systems in the arch.

[0050] First, the branch artery reconstruction assist device will be described in detail below. The branch artery reconstruction assist device includes a first stent body, which includes a bare stent section in the center and a covered stent section on the proximal side and a covered stent section on the distal side connected to both sides of the bare stent section. The branch artery reconstruction assist device is disposed at the position of the aorta and the corresponding branch artery.

[0051] As shown in FIG. 1a, in this embodiment, the branch artery reconstruction device includes a first stent body 20a, which may have a hollow cavity. The first stent body 20a includes a proximal covered stent portion 21a and a distal covered stent portion 22a, connected on both sides by a bare stent portion 23a. Before the SC branch-preferential aortic reconstruction system according to the present invention is applied, blood flows through an artery in a human body. After the first stent body 20a is released and positioned in the body, blood flows through the first stent body 20a, i.e., from the proximal side of the first stent body 20a through the bare stent portion 23a to the distal side of the first stent body 20a, i.e., from the first end of the proximal covered stent portion 21a to the second end of the distal covered stent portion 22a. The bare stent 23a here has a bendable structure so that it can accommodate various aortic structures.

[0052] The first end here may be provided at any position of the proximal covered stent portion 21 a, for example, at the distal end of the proximal covered stent portion 21 a, and the second end here may be provided at any position of the distal covered stent portion 22 a, for example, at the distal end of the distal covered stent portion 22 a, thereby preventing blood from forming a thrombus within the first stent body 20 a. The first stent body 20 a has an integral structure, i.e., the proximal covered stent portion 21 a, the bare stent portion 23 a, and the distal covered stent portion 22 a are an integral structure.

[0053] Here, the proximal-heart covered stent portion 21a and the distal-heart covered stent portion 22a are covered stents, and the bare stent portion 23a is a bare stent. When the first stent body 20a is used in the aortic arch, none of the three arch arteries are covered with a coating, and branch covered stents connecting to the first stent body 20a are implanted in the innominate artery, left common carotid artery, and left subclavian artery, respectively, in a non-ischemic state, as shown in Fig. 3. That is, the positions of the innominate artery branch covered stent 216, the common carotid artery branch covered stent 217, and the subclavian artery branch covered stent 218 relative to the bare stent portion 23a substantially coincide with the positions of the innominate artery, left common carotid artery, and left subclavian artery, respectively, at the opening of the aortic arch.

[0054] Furthermore, both the proximal and distal covered stent sections are provided with a sealing membrane and at least one first covered stent channel, the sealing membrane including at least one first opening, the first opening corresponding to a first end of the first covered stent channel, the second end of the first covered stent channel connected to a corresponding branch artery covered stent to form a branch channel and passing through the bare stent, the sealing membrane further including a second opening, the second opening of the sealing membrane in the proximal covered stent section and the second opening of the sealing membrane in the distal covered stent section communicating with each other via the aortic channel.

[0055] The first opening and the second opening may be provided in the sealing membrane as needed, but for example, in one embodiment, the first opening is provided on one side of the sealing membrane and the second opening is provided on the other side of the sealing membrane. For example, in another embodiment, the second opening is provided at the center of the sealing membrane, and the first openings are provided on both sides of the second opening.

[0056] In a specific embodiment, a total of three first covered stent channels are provided in the proximal covered stent portion 21 a and the distal covered stent portion 22 a (i.e., various numbers of first covered stent channels may be provided therein depending on the surgical practices of different physicians), and the first covered stent channels are connected to the branch artery covered stents in the innominate artery, common carotid artery, and subclavian artery, respectively, where the branch artery covered stents pass through, for example, the holes in the metal mesh of the bare stent portion 23 a. Similarly, the first covered stent channel may be configured to pass through the holes in the metal mesh of the bare stent portion 23 a and to be connected to the branch artery covered stents in the innominate artery, common carotid artery, and subclavian artery, respectively. In this embodiment, two first covered stent channels are provided in the proximal covered stent portion 21 a, and one first covered stent channel is provided in the distal covered stent portion 22 a. As known to those skilled in the art, the first coated stent channel in the distal coated stent portion 22a allows a pressure differential to induce blood flow into the channel and then into the corresponding branch artery.

[0057] The first coated stent channel may be formed by a corresponding coated inlay stent (211a, 212a, 221a). Here, the coated inlay stent may include a inlay stent body having a cavity and a coating provided on the outside of the inlay stent body. That is, the first coated stent channel is formed by the cavity of the corresponding coated inlay stent. In some embodiments, two coated inlay stents, i.e., the first coated inlay stent 211a and the second coated inlay stent 212a, may be provided in the proximal coated stent portion 21a, while one coated inlay stent, i.e., the third coated inlay stent 221a, may be provided in the distal coated stent portion 22a.

[0058] Once the first stent body 20a is placed in the aortic arch, the branch arteries (i.e., branch blood vessels) are reconstructed by the first capped stent 211a, the second capped stent 212a, and the third capped stent 221a, and then the second stent body 50a is placed within the first stent body 20 and cooperates with the first stent body 20, thereby establishing an aortic channel and isolating the lesion in the aortic arch. In this way, by realizing the branch reconstruction priority step by using the first stent body 20a and the second stent body 50a in cooperation with each other, the branch arteries remain patent during surgery, cerebral blood flow is normally supplied, blood flow blockage is avoided, and cerebral ischemia is avoided, thereby reducing the incidence of cerebral infarction.

[0059] Furthermore, the distance between the entrance end of the branch artery corresponding to the heart-proximal covered stent portion 21a and the entrance end of the branch artery corresponding to the heart-distal covered stent portion 22a is shorter than the length of the bare stent 23a, thus making it easier for the second end of the first covered stent channel to be connected to the corresponding branch artery covered stent to form a branch channel and pass through the bare stent 23a.

[0060] In some embodiments, the radial size (i.e., diameter) of the first coated stent 211a is slightly smaller than the deployed size of the innominate artery branch coated stent in the first overlap region, the second coated stent 212a is slightly smaller than the deployed size of the common carotid artery branch coated stent 217 in the second overlap region, and the third coated stent 221a is slightly smaller than the deployed size of the subclavian artery branch coated stent 218.

[0061] In some embodiments, the shape of the first coated stent 211a and the second coated stent 212a may be oval or circular, as shown in Figure 4a. The size of the first coated stent 211a and the second coated stent 212a may be adjusted to fit the branch artery in which they need to be implanted.

[0062] In some embodiments, as shown in FIG. 5a, the shape of the third coated stent 221a may be circular or oval.

[0063] In some embodiments, the lengths of the first, second, and third covered stents 211a, 212a, and 221a embedded within the bare stent section 23a must be sufficient to nest and connect to the branch artery covered stents to avoid end leaks due to short overlapping areas. These covered stents may be partially provided within the bare stent section 23a. Branch artery covered stents, such as the left subclavian artery branch artery covered stent 218 in the corresponding branch artery, such as the left subclavian artery, may be positioned closely to these covered stents without gaps, and can be sufficiently tightly attached to the inner wall of the covered stent to prevent blood leakage. Each branch artery covered stent enters the bare stent section 23a through a hole in the metal mesh of the bare stent section 23a and is connected to the covered stent.

[0064] It should be understood that the innominate artery branch artery covered stent can be a conventional branch artery covered stent, as long as it can be implanted in the corresponding arterial branch.

[0065] In some embodiments, the distal side of the first coated stent 211a and the proximal side of the innominate artery branch coated stent are coaxially nested. The distal side of the first coated stent 211a has a first overlapping region nested with the corresponding proximal side of the innominate artery branch coated stent. The axial size of the first overlapping region (i.e., the length of the first overlapping region) is greater than a predetermined value of 30 mm, but may be greater than other predetermined values; 30 mm is merely an example. Similarly, the distal sides of the second coated stent 212a and the third coated stent 221a are also coaxially nested, and the overlapping region is set to a predetermined value so that the branch artery covered stent has a sufficient contact surface with the coated stent so that the branch artery covered stent is firmly connected to the coated stent after being released into the coated stent.

[0066] 6, the length of the heart-distant covered stent portion 22a is longer than the length of the portion overlapping with the third covered, inlaid stent 221a. Therefore, after the second stent body 50a is implanted in the aortic arch, the second stent body 50a overlaps the first stent body 20a by a sufficient amount, but does not cover the distal side of the inlaid covered stent (i.e., the third covered, inlaid stent 221a) in the distal covered portion of the first stent body 20a (i.e., the heart-distant covered stent portion 22a). Furthermore, when used in the thoracoabdominal aorta, even if it is necessary to further extend the covered stent (i.e., extend the heart-distant covered stent portion 22a) on the distal side of the first stent body 20a, the second stent body 50a does not cover the opening of the inlaid covered stent (i.e., the third covered, inlaid stent 221a).

[0067] In some embodiments, sealing membranes (219a, 229a) are provided inside the proximal covered stent section 21a and the distal covered stent section 22a, respectively. Specifically, the proximal covered stent section 21a has a proximal sealing membrane 219a (hereinafter referred to as the proximal sealing membrane 219a), and the distal covered stent section 22a has a distal sealing membrane 229a (hereinafter referred to as the distal sealing membrane 229a). The proximal sealing membrane 219a may be provided at any position inside the proximal covered stent section 21a, and the distal sealing membrane 229a may be provided at any position inside the distal covered stent section 22a. The placement position of the first stent body 20a after surgery should ensure that the lesion is located between the proximal sealing membrane 219a and the distal sealing membrane 229a, and that the blood flow in the patient's aorta does not come into contact with the lesion.

[0068] In some embodiments, the proximal sealing membrane 219a is a membrane that is sealed and sutured around the circumferential direction of the proximal covered stent portion 21a to the coating of the proximal covered stent portion 21a. The proximal sealing membrane 219a prevents blood from flowing freely through the aorta in the radial direction of the first stent body 20a. The sutured portion may be on the inner or outer wall of the proximal covered stent portion 21a.

[0069] Specifically, the cardiac-proximal sealing membrane 219a has a first opening 213, a first opening 214, and a second opening 215a. As shown in Fig. 4a, blood cannot flow into the first stent body 20a from the shaded area, but can only enter the first opening 213, the first opening 214, and the second opening 215a. The edge of the first opening 213 is sutured to one end of the first capped stent 211a, and the other end of the first capped stent 211a is fitted with the innominate artery branch capped stent 216 to form a blood flow channel for the reconstructed innominate artery branch vessel. The edge of the first opening 214 is sutured to one end of a second coated stent 212a, and the other end of the second coated stent 212a is fitted with a common carotid artery branch coated stent 217 to form a blood flow channel of the reconstructed common carotid artery branch vessel.

[0070] Furthermore, the sealing membrane in the proximal covered stent section is connected to the proximal end of the proximal covered stent section, and the sealing membrane in the distal covered stent section is connected to the distal end of the distal covered stent section.

[0071] In some embodiments, a cardiac-remote sealing membrane 229a is radially disposed within the cardiac-remote covered stent portion 22a. As shown in FIGS. 5a and 5b, the cardiac-remote sealing membrane 229a is in close contact with the inner wall of the cardiac-remote covered stent portion 22a and has a first opening 222 and a second opening 223. A third covered embedded stent 221a nested within the subclavian artery branch covered stent 218 is connected to the first opening 222, thereby forming a blood flow channel for the reconstructed subclavian artery branch vessel. A second stent body 50a is nested within the second opening 223, and will be described in detail later.

[0072] In this embodiment, considering that a sealing membrane is provided inside both the heart proximal side covered stent portion and the heart distal side covered stent portion, and the sealing membrane includes a first opening, which is connected to a corresponding first end of the first covered stent channel, if the connection position between the heart proximal side covered stent portion or the heart distal side covered stent portion and the sealing membrane is flush with the first end of the first covered stent channel, the sealing membrane has a flat shape, and / or if the connection position between the heart proximal side covered stent portion or the heart distal side covered stent portion and the sealing membrane is not flush with the first end of the first covered stent channel, the sealing membrane has a sloped shape.

[0073] Specifically, when the connection position between the heart proximal side coated stent portion 21a or the heart remote side coated stent portion 22a and the sealing membrane is flush with the first end of the first coated stent channel, the sealing membrane has a flat shape, and / or when the connection position between the heart proximal side coated stent portion 21a or the heart remote side coated stent portion 22a and the sealing membrane is not flush with the first end of the first coated stent channel, the sealing membrane has a sloped shape.

[0074] Here, the connection position between the sealing membrane and the heart-proximal side coated stent portion 21a or the heart-distal side coated stent portion 22a may be set according to the relative position between the first coated stent channel and the heart-proximal side coated stent portion 21a or the heart-distal side coated stent portion 22a, thereby enabling adjustment of the shape of the sealing membrane.

[0075] In some embodiments, for example, when the first end of the first coated stent channel is flush with the proximal edge of the proximal coated stent portion 21a, the proximal sealing membrane 219a is connected to the end of the proximal coated stent portion 21a, and thus the proximal sealing membrane 219a is planar, in other words, is arranged parallel to the radial direction of the proximal coated stent portion 21a, and the first openings (213, 214) are in the plane where the proximal end point of the proximal coated stent portion 21a exists. When the first end of the first coated stent channel is inside the cardiac proximal coated stent portion 21a, the cardiac proximal sealing membrane 219a is connected to the end of the cardiac proximal coated stent portion 21a, and thus the cardiac proximal sealing membrane 219a has a sloped shape, for example, a funnel shape, as shown in Figure 4b, and the first openings (213, 214) are within the cardiac proximal coated stent portion 21a.

[0076] Similarly, when the first end of the first covered stent channel is flush with the distal edge of the distal covered stent section 22a, the second sealing membrane 220a is connected to the end of the distal covered stent section 22a, and thus the distal sealing membrane 229a has a planar shape. When the first end of the first covered stent channel is located inside the distal covered stent section 22a, the second sealing membrane 220a is connected to the end of the distal covered stent section 22a, and thus the distal sealing membrane 229a has a funnel shape. It should be understood that the shapes of the proximal sealing membrane 219a and the distal sealing membrane 229a are determined independently and may be the same or different.

[0077] In some embodiments, the first coated stent 211 a and the second coated stent 212 a are closely and adjacently disposed within the proximal coated stent portion 21 a, with one end of the first coated stent 211 a and the second coated stent 212 a being flush with the proximal side of the proximal coated stent portion 21 a. The third coated stent 221 a is closely disposed within the distal coated stent portion 22 a.

[0078] Furthermore, a first positioning stent is provided at the proximal end of the proximal covered stent section and / or the distal end of the distal covered stent section. In the SC branch-preferential aortic arch reconstruction system according to the embodiment of the present application, the first stent body section is made up of three integrally joined sections. Among them, the proximal covered stent section 21a is a covered stent with channels of two sub-covered stents (e.g., a first covered embedded stent 211a and a second covered embedded stent 212a) embedded therein. A first positioning stent 24a is provided at the front end (i.e., the proximal end) of the proximal covered stent section 21a, and the apex of the first positioning stent 24a is designed to retract inward so as not to pierce the wall of the ascending aorta. The heart remote side covered stent portion 22a is a covered stent with the channel of one sub-covered stent (e.g., the third covered embedded stent 221a) embedded inside, and the bare stent portion 23a connected to the central portion is an arched bare stent.

[0079] In some embodiments, the first positioning stent 24a further includes barbs 241 (not shown in FIG. 1a) to better anchor the first stent body to the inner wall of the blood vessel. Similarly, the ends of the proximal or distal covered stent sections may also include barbs 241 (not shown in FIG. 1a).

[0080] In some embodiments, the second stent body 50a is a covered stent, and is implanted within the first stent body 20a after the first stent body is provided in the aortic arch (or thoracoabdominal aorta) and branch artery reconstruction is completed, and is arranged parallel to the first covered stent channels in both sides thereof (i.e., the near-heart covered stent portion 21a and the far-heart covered stent portion 22a), and is configured to cooperate with the first stent body 20a to isolate the diseased portion of the aorta.

[0081] Furthermore, a leak prevention channel is provided in the near-heart side covered stent portion and / or the far-heart side covered stent portion, and one end of the leak prevention channel is connected to the second opening and the other end is connected to the corresponding end of the second stent body.

[0082] In some embodiments, second openings (215, 223) are formed in the sealing membrane, and blood flows from the second opening 215 to the bare stent portion 23a and from the bare stent portion 23a through the second opening 223. Furthermore, the proximal side of the second stent body 50a may be connected to the second opening 215, and the distal side of the second stent body 50a may be connected to the second opening 223, thereby isolating the aortic arch lesion 41 or the thoracoabdominal aorta lesion. Furthermore, to facilitate removable placement of the second stent body 50a within the first stent body 20a, anti-leak channels are provided within the proximal covered stent portion 21a and the distal covered stent portion 22a, respectively, with one end of the anti-leak channel connected to the second opening and the other end of the anti-leak channel connected to the second stent body 50a. That is, the second stent body 50a is connected to a branch artery via the first stent body 20a, and is then provided within the bare stent portion 23a, and is used to connect the blood flow within the aorta.

[0083] In some embodiments, a first leak prevention channel 71a is provided in the proximal covered stent section 21a, and a second leak prevention channel 72a is provided in the distal covered stent section 22a. In this manner, the second stent body 50a may be removably nested within the first leak prevention channel 71a and the second leak prevention channel 72a. One end (e.g., proximal side) of the first leak prevention channel 71a is connected to the second opening 215 of the proximal sealing membrane 219a, and the other end (e.g., distal side) of the first leak prevention channel 71a abuts against the outer wall of the second stent body 50a. One end (e.g., the heart remote side) of the second leak prevention channel 72a is connected to the second opening 223 of the heart remote side sealing membrane 229a, and the other end (e.g., the heart proximal side) of the second leak prevention channel 72a abuts against the outer wall of the second stent body 50a.

[0084] In some embodiments, the proximal side of the coated stent in the proximal covered stent section 21a does not extend beyond the proximal side of the second stent body 50a, and as shown in FIG. 6, the linear distance between the proximal side of the third coated stent 221a and the proximal side of the second stent body 50a does not exceed 10 mm. Similarly, the distance between the distal side of the stent in the distal covered stent section 22a and the distal side of the second stent body 50a may also be set to within 10 mm. In this way, the two stent systems are firmly attached to each other, ensuring no endoleaks.

[0085] In some embodiments, the second stent body 50a is a coated stent. The second stent body 50a includes a second stent body and a third coating disposed on the outer wall of the second stent body. That is, the third coating is sutured to the outer wall of the second stent body. The diameter of the second stent body 50a is equal to or slightly larger than the inner diameter of the first stent body 20a, thereby ensuring strong adhesion between the second stent body 50a and the first stent body 20a and preventing endoleaks.

[0086] In some embodiments, the second stent body (50a, 50b) is radially flexible, which can be achieved, for example, by polishing the outer surface of the second stent body (50a, 50b). The second stent body (50a, 50b) has a first barb 51a (or a first barb 51b in the second stent body 50b) on the proximal side of the heart, which allows the second stent body 50a (or the second stent body 50b) to engage with the first stent body 20a (or the first stent body 20b). A second barb 52a (or a second barb 52b in the second stent body 50b) may be optionally provided on the distal side of the second stent body (50a, 50b), thereby ensuring good engagement of the second stent body 50a (or the second stent body 50b) with the first stent body 20a (or the first stent body 20b). This ensures that the second stent body (50a, 50b) and the first stent body (20a, 20b) are in close contact with each other and do not slip off. This effectively seals the bare stent portion 23a of the first stent body 20a, isolating the lesion in the aortic arch. After implantation of the second stent body 50a, a compliance balloon may be used to appropriately expand the coated stent of the second stent body 50a to ensure its sealing.

[0087] Furthermore, a second positioning stent is provided at the end of the second stent body, and the second stent body is connected to the end of the leak prevention channel by the second positioning stent.

[0088] In some embodiments, the proximal side of the second stent body 50a may further include a second positioning stent 53a, and the apical end of the second positioning stent 53a may be recessed from the proximal side toward the distal side to avoid damage to the aortic wall by the second positioning stent 53a and to facilitate release of the second stent body 50a.

[0089] In some embodiments, the first leak prevention channel 71a and the second leak prevention channel 72a are connected to the second opening 215a and the second opening 223a, respectively, and the front and rear sides of the second stent body 50a are removably nested within the first leak prevention channel 71a and the second leak prevention channel 72a, respectively. The proximal side of the first leak prevention channel 71a is connected to the second opening 215a, and at the same time, within the proximal-side covered stent section 21a, the outer wall of a first portion of the first leak prevention channel 71a is in close contact with the inner wall of the proximal-side covered stent section 21a. The outer wall of a second portion of the first leak prevention channel 71a is in close contact with the outer walls of the first and second covered stents 211a and 212a. The heart remote side of the first leak prevention channel 71a is connected to the second opening 223a, and at the same time, within the heart remote side coated stent portion 22a, the outer wall of the first part of the second leak prevention channel 72a is in close contact with the inner wall of the heart remote side coated stent portion 22a, and the outer wall of the second part of the second leak prevention channel 72a is in close contact with the outer wall of the third coated embedded stent 221a.

[0090] In some embodiments, the first anti-leak channel and the second anti-leak channel may be comprised of a coating.

[0091] When using the SC branch-priority aortic and branch artery reconstruction system according to the present embodiment, the first stent body 20a and the second stent body 50a are implanted in the aortic arch, respectively. The first stent body 20a is first implanted in the aortic arch while remaining open to ensure blood supply to the brain. The reconstruction of each branch artery in the aortic arch is prioritized. After the blood supply of the three aortic arch arteries is reconstructed, the second stent body 50a is placed within the first stent body 20a. Thus, the establishment of the aortic channel is completed while isolating blood flow from the lesion site. At this point, the patency and sealing of the aorta and each branch artery are ensured, preventing blood leakage (to the lesion site) and isolating the lesion site in the aortic arch. The channels fitted within the first stent body 20a are connected to the second stent body 50a, achieving seamless sealing and connection on both the proximal and distal cardiac sides, thereby preventing endoleaks. By ensuring blood circulation during the process of reconstructing the superior aortic arch, ischemia is avoided, ensuring normal cerebral blood flow during surgery, preventing cerebral ischemia and reducing the incidence of cerebral infarction. After branch reconstruction is complete, the ascending aortic section proximal to the heart, the central aortic arch, and the descending aortic section distal to the heart are sealed with a unified second stent body 50a to isolate the lesion. Operation is simple, avoiding the complicated connection steps required for modular systems. Objectively, this system avoids end leaks between modules due to operational difficulties or imprecise operation.

[0092] In some embodiments, the SC branch-preferential aortic reconstruction system may be an SC branch-preferential thoracoabdominal aortic reconstruction system, which is similar in structure to an SC branch-preferential aortic arch reconstruction system. The aorta may include the thoracoabdominal aorta, and the branch arteries may be thoracoabdominal visceral quadrant branch arteries, including a celiac trunk branch, a superior mesenteric artery branch, a left renal artery branch, and a right renal artery branch. The branch artery covered stents include a celiac trunk branch artery covered stent 61, a superior mesenteric artery branch artery covered stent 62, a left renal artery branch artery covered stent 63, and a right renal artery branch artery covered stent 64. The SC branch-preferential thoracoabdominal aortic reconstruction system includes a first stent body 20b, a sealant membrane, and a second stent body 50b. Figures 7 to 8f are schematic diagrams illustrating the first stent body 20b and the second stent body 50b used individually and in combination, respectively. The first stent body 20b includes a bare stent portion 23b, and a proximal-heart covered stent portion 21b and a distal-heart covered stent portion 22b connected by the bare stent portion 23b. When implanted in the body, the first stent body 20b is provided to straddle both sides of the aorta at a lesion wound around a visceral artery branch region. The second stent body 50b is a covered stent body nested within the bare stent portion 23b when the first stent body 20b is provided in the visceral artery branch region of the thoracic-abdominal aorta, allowing this SC branch-priority aortic reconstruction system to isolate the lesion in the visceral artery segment.

[0093] As shown in Figure 8b, the relative positions of the celiac trunk branch artery covered stent 61, the superior mesenteric artery branch artery covered stent 62, the left renal artery branch artery covered stent 63, and the right renal artery branch artery covered stent 64 within the visceral artery branch region approximately coincide with the positions of the openings in the thoracic and abdominal artery branch region of the celiac trunk branch, the superior mesenteric artery branch, the left renal artery branch, and the right renal artery branch, among the branch arteries in the thoracic and abdominal artery branch region, respectively.

[0094] In some embodiments, one coated stent may be provided in the near-heart coated stent portion 21b, while three coated stents may be provided in the far-heart coated stent portion 22b, and in this manner, a superior mesenteric artery branch channel may be constructed by blood circulation within the coated stents in the far-heart coated stent portion 22b.

[0095] In some embodiments, two coated stents may be provided inside each of the proximal and distal covered stent sections 21 b and 22 b. As shown in FIG. 7 a, the first coated stent 211 b and the second coated stent 212 b in the proximal covered stent section 21 b are adjacently attached to each other and are located on one side of the first leak prevention channel 71 b. Meanwhile, the third coated stent 221 b and the fourth coated stent 226 in the distal covered stent section 22 b are attached to opposite sides of the second leak prevention channel 72 b in the distal covered stent section 22 b.

[0096] 9a, within the proximal cardiac covered stent portion 21b, a proximal cardiac sealing membrane 219b is radially disposed, and the proximal cardiac sealing membrane 219b is attached to the inner wall of the proximal cardiac covered stent portion 21b. The proximal cardiac sealing membrane 219b has a first opening 213b, a first opening 214b, and a second opening 215b, thereby forming a plurality of blood flow channels. The first opening 213b is sutured to a fourth covered embedded stent 211b, which passes through the bare stent portion 23b and is nested within the celiac trunk branch artery covered stent 61 to form a reconstructed celiac trunk pathway. The first opening 214b is sutured to a fifth coated stent 212b, which is nested within the superior mesenteric artery branch coated stent 62 to form a blood flow channel for the reconstructed superior mesenteric artery branch vessel. A first leak prevention channel 71b is connected to the second opening 215b and extends to the bare stent portion 23b, allowing blood to flow from the second opening 215b to the bare stent portion 23b.

[0097] 9b, a distal sealing membrane 229b is radially disposed within the distal covered stent portion 22b, and is attached to the inner wall of the distal covered stent portion 22b. The distal sealing membrane 229b has a first opening 222b, a first opening 25b, and a second opening 223b. Correspondingly, the first opening 222b is sutured to the sixth covered stent 221b, and blood flows through the first opening 222b into the sixth covered stent 221b, and then flows to the left renal artery branch via the left renal artery branch covered stent 63 nested within the sixth covered stent 221b. The first opening 25 is connected to a seventh coated stent 226, which is placed over the outer wall of the right renal artery branch coated stent 64, thereby forming a blood flow channel for the reconstructed right renal artery branch vessel. In some embodiments, a second leak prevention channel 72b is connected to the second opening 223b and extends to the bare stent portion 23b, allowing blood to flow from the second opening 223b to the bare stent portion 23b. A second stent body 50b is nested within the first and second leak prevention membranes, i.e., both sides of the second stent body 50b are detachably connected to the first and second leak prevention membranes, thereby communicating the proximal and distal sides of the first stent body 20b.

[0098] As described above, under an ischemia-free condition, the blood flow channels of the celiac trunk branch, the superior mesenteric artery branch, and the renal artery branch can be reconstructed, respectively, thereby achieving the reconstruction of the blood supply of the thoracic and abdominal visceral quadrant arteries.

[0099] In some embodiments, in the proximal covered stent section 21b, a portion of the outer wall of the first leak prevention membrane is attached to the inner wall of the proximal covered stent section 21b, and another portion of the outer wall of the first leak prevention membrane is attached to the outer walls of the fifth covered stent 212b and the fourth covered stent 211b. In the distal covered stent section 22b, a portion of the outer wall of the second leak prevention membrane is attached to the inner wall of the distal covered stent section 22b, and another portion of the outer wall of the second leak prevention membrane is attached to the outer walls of the sixth covered stent 221b and the seventh covered stent 226.

[0100] 10a and 10b, the sixth coated stent 221b and the seventh coated stent 226 are distributed at symmetrical positions on both sides of the heart-remote coated stent portion 22b. That is, the sixth coated stent 221b and the seventh coated stent 226 are attached to opposite radial sides of the heart-remote coated stent portion 22b. The sixth coated stent 221b and the seventh coated stent 226 may each independently be circular or elliptical. The sixth coated stent 221b and the seventh coated stent 226 may each slightly protrude from the proximal covered stent portion 21b and may extend into the area of ​​the bare stent portion 23b (for example, the length extending into the area of ​​the bare stent portion 23b may be approximately 5 mm), thereby allowing them to be nested well within the left renal artery branch coated stent 63 and the right renal artery branch coated stent 64. Of course, the above is merely an example, and not only the sixth coated stent 221b and the seventh coated stent 226 may protrude slightly from the proximal covered stent portion 21b.

[0101] Specifically, the material of the coating of each coated stent may be polytetrafluoroethylene, etc. Meanwhile, the material of each sealing membrane and leak prevention channel may be the same as the material of the coating. Each coating may be sutured to the stent. The shape of each leak prevention channel may be the same or different. For example, all may be annular leak prevention membranes, sewn like a sleeve to the adjacent coating and to the surface of the stent adjacent to the coating.

[0102] The distal end of the distal covered stent portion further includes an extension stage, and two parallel second covered stent channels are provided within the extension stage, one of which is within the extension stage and the other of which extends outside the extension stage to communicate with the corresponding branch artery covered stent, and the two second covered stent channels fill the extension stage. In one embodiment, the cross sections of the two second covered stent channels are double-D shaped.

[0103] 7c and 7d, the first stent body 20b further includes a distal covered stent extension section 67 on the distal side thereof, and second covered stent channels (224, 225) are connected to the distal end of the distal covered stent extension section 67. The second covered stent channels (224, 225) communicate with the external iliac artery branch covered stent 65 and the internal iliac artery branch covered stent 66, respectively. The second covered stent channels (224, 225) are respectively attached to the distal covered stent extension section 67 and are arranged adjacent to each other in parallel, the distal side of the second covered stent channel 224 and the proximal side of the external iliac artery branch covered stent 65 being coaxially nested, and the distal side of the second covered stent channel 225 and the proximal side of the external iliac artery branch covered stent 65 being coaxially nested. In this way, reconstruction of the aorta and branch arteries when the aortic disease extends to the abdominal aorta can be achieved.

[0104] In some embodiments, as shown in Figures 11a and 11b, adjacent sidewalls of the proximal side of the second coated stent channel 224 and the proximal side of the second coated stent channel 225 are attached to each other, and non-adjacent sidewalls of the proximal side of the second coated stent channel 224 and the proximal side of the second coated stent channel 225 are attached to the inner wall of the extended section of the second coated stent section 67. It can be seen that the proximal side of the second coated stent channel 224 and the proximal side of the second coated stent channel 225 (facing the blood flow) are kiss-sewn together to form a double "D" shape, thereby ensuring a leak-free seal, and gradually naturally extending to an oval or circular shape at the distal end. In this way, the second coated stent channel 224, the second coated stent channel 225, and the extended section of the distal stent section are tightly sewn together by the coating, thereby ensuring no blood leaks.

[0105] In some embodiments, the size of the second coated stent channel 224 on the distal side of the heart and the size of the branch artery coated stent of the external iliac artery branch artery 65 on the proximal side of the heart are the same, and the size of the second coated stent channel 225 on the distal side of the heart and the size of the branch artery coated stent of the internal iliac artery branch artery 66 on the proximal side of the heart are the same.

[0106] In some embodiments, as shown in Figures 8c and 8d, the proximal side of the external iliac artery branch covered stent 65 is nested within the distal side of the second covered stent channel 224, and the proximal side of the internal iliac artery branch covered stent 66 is nested within the distal side of the second covered stent channel 225.

[0107] In some embodiments, as shown in Figure 7d, the size of the second covered stent channel 224 is smaller in the axial direction than the size of the second covered stent channel 225. Thus, as shown in Figures 8e and 8f, the proximal side of the external iliac artery branch covered stent 65 is nested within the distal side of the second covered stent channel 224, and the proximal side of the internal iliac artery branch covered stent 66 is nested within the distal side of the second covered stent channel 225.

[0108] An embodiment of the present application also provides an SC branch-priority aortic reconstruction system that includes a branch artery reconstruction assist device according to any of the embodiments and a second stent body, wherein the second stent body is a covered stent for forming an aortic channel, and is disposed within the first stent body after the first stent body is positioned and released and branch artery reconstruction is completed, and is used to form the aortic channel, thereby connecting blood flow within the aorta while isolating the lesion site.

[0109] In the SC branch-preferential aortic reconstruction system, both sides of the second stent body communicate with the second opening in the sealing membrane in the near-heart covered stent portion and the second opening in the sealing membrane in the far-heart covered stent portion, respectively.

[0110] In the SC branch-preferential thoracic and abdominal aortic reconstruction system according to the present embodiment, the system is implanted in two parts. The first stent body prioritizes the reconstruction of the branch vessel while remaining open to ensure blood circulation to the internal organs. The second stent body cooperates with the first stent body to complete the establishment of the aortic channel and isolate the lesion in the branch artery area. The first stent body is divided into three integrally joined sections. The proximal covered stent section 21b is a covered stent with two adjacent covered stents (i.e., a first covered embedded stent 211b and a second covered embedded stent 212b) embedded inside. The apex of the second positioning stent 53a of the proximal covered stent section 21b is designed to fit inside the ascending aortic wall so as not to puncture it. A barb is sewn to the outer edge of the cover at the front end of the proximal covered stent section 21b to prevent it from shifting position. The distal covered stent portion 22b has two symmetrical covered stents (i.e., the third and fourth covered stents 221b and 226) embedded therein, and the central connecting portion (i.e., the bare stent portion 23b) is a loose-mesh bare stent. The covered stent portions of the first stent body (including the proximal covered stent portion 21b and the distal covered stent portion 22b) ensure a tight seal when the embedded branch channels are sutured to the main covered stent, and the inward-facing portions of the embedded branch channels and the main covered stent maintain a regular elliptical shape, thereby forming a seamless fit with the implanted second stent body covered stent, thereby achieving the goal of proximal-end sealing. The second stent body is used to seal and isolate the lesion, is radially flexible, and has barbs at both the proximal and distal ends to prevent displacement, thereby ensuring that the coated stent of the first stent body with the channel fitted inside is seamlessly attached and firmly bonded at the proximal end.

[0111] In use, the SC branch-prioritized thoracic abdominal aortic reconstruction system according to the present embodiment involves sequentially placing the first stent body 20b and the second stent body 50b in the affected visceral branch region of the thoracic abdominal aorta. The first stent body 20b is first implanted in the aortovisceral artery, while the system is left open to ensure blood supply to the visceral organs. Then, the branch artery-covered stents are implanted. This allows for the preferential reconstruction of each branch artery of the aortovisceral artery. The second stent body 50b is then implanted within the first stent body 20b, overlapping and covering the first stent body 20b, to isolate the affected area of ​​the thoracic abdominal aorta. The connection between the first stent body 20b and the second stent body 50b provides a seamless seal and connection on both the proximal and distal sides of the heart, preventing endoleaks. During the aortovisceral artery branch reconstruction, the entrances of the visceral artery branches are all located in the bare stent portion 23b, which is not covered by a capsular membrane. Therefore, under an ischemic condition, the branched covered stents are implanted, connecting them to the celiac trunk, superior mesenteric artery, and left and right renal arteries via respective capsular embedded stents. This completes the reconstruction of the blood supply to the thoracic-abdominal visceral arteries, maintaining circulation and preventing ischemia. This ensures normal cerebral blood flow during surgery and avoids ischemia. Furthermore, by placing a flexible second stent body 50b overlapping the first stent body 20b, the patency of each branch is ensured while sealing the lesions in the visceral artery region, thereby reducing the incidence of complications. After the branch reconstruction is complete, the ascending aorta, the middle arch, and the descending aorta distal to the heart are uniformly sealed with the second stent body 50b to isolate the lesions. The operation is simple, and the complicated connection steps required for modular systems are avoided. Objectively, the difficulty of operation and the risk of end leaks between modules caused by inaccurate operation are avoided.

[0112] As will be understood by those skilled in the art, the discussion of any of the above embodiments is merely illustrative and should not be construed as meaning that the scope of the present disclosure (including the claims) is limited to these examples. Under the concept of the present disclosure, combinations of technical features in the above embodiments or different embodiments are also possible, steps may be implemented in any order, and there are many other variations of various aspects of the embodiments of the present disclosure as described above, which are not provided in detail for the sake of clarity.

[0113] While the present disclosure has been described with reference to specific embodiments, many permutations, modifications, and variations of these embodiments will become apparent to those skilled in the art in light of the foregoing description.

[0114] The embodiments of the present disclosure are intended to encompass all such replacements, modifications, and variations that fall within the broad scope of the appended claims. Therefore, any omissions, modifications, equivalent replacements, improvements, etc. made without departing from the spirit and principles of the embodiments of the present disclosure should also fall within the scope of protection of the present disclosure.

Claims

1. A branch artery reconstruction assist device, a first stent body including a bare stent portion, a proximal-side covered stent portion and a distal-side covered stent portion connected to both sides of the bare stent portion, a sealing membrane and at least one first covered stent channel provided inside each of the proximal-side covered stent portion and the distal-side covered stent portion, the sealing membrane including a first opening, the first opening being connected to a corresponding first end of the first covered stent channel, and a second end of the first covered stent channel being connected to a corresponding branch artery covered stent to form a branch channel, the sealing membrane passing through the bare stent.

2. 2. The branch artery reconstruction assist device according to claim 1, wherein the distance between the inlet end of the branch artery corresponding to the covered stent portion on the proximal side of the heart and the inlet end of the branch artery corresponding to the covered stent portion on the distal side of the heart is shorter than the length of the bare stent.

3. 2. The branch artery reconstruction assist device according to claim 1, wherein the bare stent has a bendable structure.

4. 2. The branch artery reconstruction assist device according to claim 1, wherein when the connection position between the covered stent portion near the heart or the covered stent portion far from the heart and the sealing membrane is flush with the first end of the first covered stent channel, the sealing membrane has a flat shape, and / or when the connection position between the covered stent portion near the heart or the covered stent portion far from the heart and the sealing membrane is not flush with the first end of the first covered stent channel, the sealing membrane has a sloped shape.

5. 5. The branch artery reconstruction assist device according to claim 4, wherein the sealing membrane in the proximal-heart side covered stent section is connected to the proximal-heart end of the proximal-heart side covered stent section, and the sealing membrane in the distal-heart side covered stent section is connected to the distal-heart end of the distal-heart side covered stent section.

6. 2. The branch artery reconstruction assist device according to claim 1, wherein a first positioning stent is provided at the proximal end of the proximal covered stent portion and / or at the distal end of the distal covered stent portion.

7. 7. The branch artery reconstruction assist device according to claim 1, wherein the sealing membrane further includes a second opening, and the second opening of the sealing membrane in the covered stent section proximal to the heart and the second opening of the sealing membrane in the covered stent section distal to the heart communicate with each other via an aortic channel.

8. The branch artery reconstruction assist device according to claim 7, wherein the first opening is provided on one side of the sealing membrane, and the second opening is provided on the other side of the sealing membrane.

9. The branch artery reconstruction assist device according to claim 7, wherein the second opening is provided at a central position of the sealing membrane, and the first openings are provided on both sides of the second opening.

10. 8. The branch artery reconstruction assist device according to claim 7, wherein an extension stage is provided at the heart remote end of the heart remote side covered stent portion, and two parallel second covered stent channels are provided within the extension stage, a portion of the second covered stent channel is provided within the extension stage, and another portion extends outside the extension stage to communicate with a corresponding branch artery covered stent, and the two second covered stent channels fill the extension stage.

11. The branch artery reconstruction assist device according to claim 10, wherein the cross sections of the two second coated stent channels are double D-shaped.

12. An SC branch-preferential aortic reconstruction system, comprising:

12. An S-C branch-prioritizing aortic reconstruction system comprising: a branch artery reconstruction assist device according to any one of claims 7 to 11; and a second stent body, wherein the second stent body is a covered stent for forming an aortic channel, and is disposed within the first stent body after the positioned release of the first stent body is completed and branch artery reconstruction is completed, and is used to form the aortic channel, thereby realizing the connection of blood flow within the aorta while isolating the lesion site.

13. 13. The S-C branch-priority aortic reconstruction system according to claim 12, wherein both sides of the second stent body are in communication with the second opening in the sealing membrane in the covered stent portion proximal to the heart and the second opening in the sealing membrane in the covered stent portion distal to the heart, respectively.

14. 13. The S-C branch-priority aortic reconstruction system according to claim 12, characterized in that a leak prevention channel is provided in the heart-proximal side covered stent portion and / or the heart-distal side covered stent portion, and one end of the leak prevention channel is connected to the second opening and the other end is connected to a corresponding end of the second stent body.

15. The SC branch-priority aortic reconstruction system of claim 14, characterized in that a second positioning stent is provided at the end of the second stent body, and the second stent body is connected to the end of the leak prevention channel by the second positioning stent.

Images