Branch artery reconstruction assist device and SC branch priority aortic reconstruction system

Abstract

The present application provides an S-C branch-priority aorta reconstruction system, including a first stent body, a second stent body and each branch artery covered stent. The first stent body includes a bare stent portion in the middle and a covered stent portion connected to both ends of the bare stent portion, and a blocking film arranged on the covered stent portion, the covered stent portion is provided with at least one first covered stent channel, the blocking film has a second opening and at least one first opening, each first opening is connected to a covered stent channel, and any end of the first covered stent channel is connected to the corresponding branch artery covered stent to form a channel that passes through the pore gap of the bare stent portion; the second stent body is a covered stent, which is used to be implanted into the first stent body to complete the isolation of the lesion after the first stent body is positioned and released and the branch artery covered stent is implanted to complete the reconstruction of the branch artery. Compared with the prior art, the present application solves the problem of organ ischemia during branch artery reconstruction and the problem of internal leakage of the existing stent.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a branch artery reconstruction auxiliary device and an aorta and branch artery reconstruction system. Background Art

[0002] The aorta is the largest artery in the human body and the main pathway for transporting blood to all parts of the body. It originates from the left ventricle of the heart, and is slightly arched upward, rightward, and downward, and then descends along the spine. Many smaller arteries are divided into the ascending aorta, the aortic arch, and the thoracic and abdominal aorta (the thoracic and abdominal aorta refers to the aorta from below the left subclavian artery to above the iliac arteries on both sides. The aorta above the diaphragm is called the descending thoracic aorta, and the aorta below the diaphragm is called the abdominal aorta). Dangerous aortic lesions mainly include aortic aneurysms and aortic dissections. In clinical practice, aortic arch lesions (mainly aortic aneurysms or aortic dissections) have always been a major problem in the treatment of vascular diseases, and the non-surgical mortality rate is extremely high. However, there are many problems with current treatment methods, and death, paraplegia, cerebral embolism and acute renal failure all occur from time to time. If surgical treatment is used, there are many anastomoses, the anastomosis is difficult, intraoperative bleeding and deep hypothermic circulatory arrest, and a series of serious complications.

[0003] With the rapid development of thoracic endovascular aortic repair (TEVAR) technology and devices, the indications of TEVAR have been expanded from descending aortic lesions to aortic arch lesions. However, due to its complex anatomical structure, aortic arch diseases have always been a forbidden zone for endovascular interventional treatment. The main difficulty lies in how to ensure that the aortic arch lesions are isolated while maintaining the patency of the branch vessels above the arch. Although there are many off-indication equipment applications for interventional treatment, a variety of aortic endovascular reconstruction technologies have been tried, including fenestrated stents, customized stents, chimney technology, and "skirt stents" designed specifically for chimney technology, modular branch artery covered stent-type vascular endovascular reconstruction, etc. However, the problems of blood flow blockage during surgery and the long-term patency rate of branch artery covered stents are not satisfactory. At present, there are no mature endovascular treatment products that can be widely applied in clinical practice.

[0004] Currently, the "chimney" technique and "fenestration" technique are mainly used clinically to assist in the endovascular treatment of aortic dissection or aneurysm involving the aortic arch. However, common problems include "endoleakage" between the main and branch artery covered stents and the mismatch between them, which brings great challenges to clinical treatment. Potential risks such as endoleak and stent migration have not yet been resolved.

[0005] In order to solve the problems of internal leakage and long-term patency of branch artery stent grafts in chimney technology, based on in-depth insights into clinical needs, the inventors developed the aortic arch stent system (fenestrated type), the CSkirt aortic arch branch artery stent graft system (fenestrated skirt stent), which punctures the aortic arch main stent to form a puncture point through the aortic stent graft membrane rupture system, and then uses a balloon to expand the puncture point to form a "window" for blood circulation, and then sends the CSkirt aortic arch branch artery stent graft (fenestrated skirt stent) along the guide wire to pass through the "window" and release. During use, it was found that this structure has problems such as complex operation.

[0006] On the other hand, aortic diseases involving visceral artery branches (visceral artery branches mainly refer to the renal artery, celiac artery and superior mesenteric artery) mainly include thoracoabodminal aortic aneurysm (TAAA), aortic dissection (AD) and abdominal aortic aneurysm (AAA). The common feature of thoracoabodminal aortic aneurysm and some aortic dissections and abdominal aortic aneurysms is that the lesions involve visceral artery branches, or during the treatment process, the range of these visceral artery branches may be involved.

[0007] Taking thoracoabdominal aortic aneurysm as an example, thoracoabdominal aortic aneurysm refers to an aneurysmal dilatation disease that affects both the thoracic aorta and the abdominal aorta. The range of the lesion is complex and extensive, generally involving important visceral blood vessels such as the intercostal arteries, celiac trunk, superior mesenteric artery or bilateral renal arteries.

[0008] Traditional endovascular aneurysm repair (EVAR) still has difficulties in treating juxtarenal abdominal aortic aneurysms, thoracoabdominal aortic aneurysms involving abdominal aortic branch vessels, and aortic dissection. How to reconstruct the blood supply to the visceral arteries is the main obstacle. For aortic diseases involving visceral artery branches, simple covered stents cannot be used for treatment due to the perfusion and blood supply relationship of the visceral arteries. Endovascular repair technology reconstructs the blood supply of visceral artery branches and reduces the huge trauma caused by open surgery. It plays an important role in the treatment of aortic diseases involving visceral artery branches. The endovascular repair techniques used mainly include chimney, sandwich, fenestration and multi-branch techniques; specifically,

[0009] The chimney stent was first used as a remedial measure after the stent-type artificial blood vessel accidentally covered the branch blood vessel. It is currently mainly used in patients with near-renal abdominal aortic aneurysm whose physical conditions are not suitable for open surgery and whose anatomical conditions are not suitable for fenestration and multi-branch technology treatment. Because the chimney stent is located between the stent-type artificial blood vessel and the native arterial wall, the incidence of endoleak is high. Although the sandwich technology has shown good short-term effects, its long-term stability and effectiveness still need to be further verified. The fenestration technology has strict requirements on the anatomical conditions of the patient's aneurysm. The aneurysm neck that is twisted into an angle that is too large will affect the precise alignment of the fenestration and the target blood vessel. Like the fenestration technology, the multi-branch technology is complex to operate, expensive, and requires individual customization. It is currently only used in a small number of patients.

[0010] Currently, the main methods for treating TAAA include open surgery and hybrid surgery, etc. Since both open surgery and hybrid surgery cannot avoid laparotomy, they are extremely traumatic and require complex reconstruction of visceral arteries. There are still risks of perioperative massive bleeding, shock, cardiac arrest, and multiple organ failure. Summary of the invention

[0011] In view of this, the purpose of the present application is to propose a branch artery reconstruction auxiliary device and a branch-priority aorta reconstruction system to solve the problems of serious complications such as endoleak and arterial ischemia that cannot be avoided in the prior art.

[0012] Based on the above-mentioned purpose, the present application provides a branch artery reconstruction auxiliary device, including a first stent body, the first stent body including a bare stent part and a coated stent part connected to the two ends of the bare stent part, so that blood can flow from one coated stent part to the other coated stent part; at least one first coated stent channel is provided in the coated stent part, the first stent body also includes a blocking film arranged in the coated stent part, which has a second opening and at least one first opening, each of the first openings is correspondingly connected to a first coated stent channel, any end of the first coated stent channel is connected to the corresponding branch artery coated stent, and the channel formed by it passes through the gap of the bare stent part and extends to the inner and outer sides of the bare stent part respectively; blood flows through the blocking film through the first opening at the blood-facing end of the first stent body, enters the first coated stent channel, and then flows into the branch artery where it is located through the corresponding branch artery coated stent, and at the same time, blood also enters or flows out of the first stent body through the second opening (not isolated from the lesion). It should be understood that the first coated stent channel can be passed through the first opening, and the position where it is passed through the first opening can be any position, such as the two ends in the extension (ie, length) direction of the first coated stent channel, or any position between the two ends.

[0013] Specifically, the coated stent portions at both ends of the bare stent portion are respectively a first coated stent portion and a second coated stent portion.

[0014] In some preferred embodiments, the occluding membrane is disposed at a first end of the first coated stent portion and a second end of the second coated stent portion.

[0015] In some preferred embodiments, the bare stent portion is a stent without a coating.

[0016] In some preferred embodiments, the number of the first openings is the same as the number of the first stent graft channels. The plurality of first openings and the plurality of first stent graft channels are respectively arranged in a one-to-one correspondence to achieve reconstruction of the blood flow channels in the corresponding branch arteries. The first opening is connected to one end of the first stent graft channel.

[0017] The occluding membrane can be arranged at any position of the first coated stent portion and / or the second coated stent portion, preferably, can be arranged at the blood-facing end thereof, that is, the first end of the first coated stent portion and / or the second end of the second coated stent portion is the blood-facing end.

[0018] In some preferred embodiments, the first stent graft channel can be formed by a corresponding coated embedded stent, or other structures in the prior art that can be used to separately connect the aorta and its branch arteries. The coated embedded stent can include an embedded stent body with a cavity and a coating disposed outside the embedded stent body. That is, the first stent graft channel is formed by the cavity of the corresponding coated embedded stent.

[0019] In some preferred embodiments, the cross-section of the first stent graft channel is circular or elliptical, so that the first stent graft channel can match the shape of the branch artery or the branch artery stent graft, and there is no gap after fitting, and no bleeding.

[0020] In some preferred embodiments, a branch artery covered stent is provided in the branch artery, and the blood flow channel formed after the branch artery covered stent is connected with the first covered stent channel is partially located inside the bare stent part and partially located outside the bare stent part. Any point in the first covered stent channel has an overlapping area nested with the proximal end of the corresponding branch artery covered stent. In this way, the corresponding branch artery channel can be formed by the nested overlapping arrangement of the first covered stent channel and the corresponding branch artery covered stent, thereby improving the stability of the branch artery vascular pathway and better completing the reconstruction of the arterial branch blood vessels without bleeding.

[0021] In some preferred embodiments, the branch artery stent graft and the corresponding first stent graft channel in the overlapping area abut against each other, and there is no gap between the abutting surfaces, thereby preventing bleeding and preventing the branch artery stent graft from falling off.

[0022] In some preferred embodiments, the length of the overlapping area is greater than a preset size to ensure that there is enough contact surface between the first stent graft channel and the branch artery stent graft, so as to prevent bleeding, improve the ability of the branch artery stent graft to resist blood flow impact, and improve the stability of the branch artery stent graft. For example, the preset size can be any length that can be used to increase the connection stability between the first stent graft channel and the corresponding branch artery stent graft. Of course, it is also possible to prevent the branch artery stent graft from falling off due to blood flow impact by presetting a barb on the branch artery stent graft for fixing the inner wall of the first stent graft channel.

[0023] In some preferred embodiments, a positioning bracket for connecting to a stent conveyor is provided at one end of the first stent body; further, the end of the first coated stent part or the second coated stent part connected to the positioning bracket is flush with the positioning bracket plane. Further, the positioning bracket can be a bare stent, which can be understood as a stent without a coating, and whose tip is designed to be inward-adducted to avoid the tip from piercing the aortic wall, and is mainly used for releasing the first stent body in vivo.

[0024] Specifically, the positioning bracket is generally arranged at the position where the first stent body is located at the proximal end, that is, when the first stent graft portion is at the proximal end, the positioning bracket is arranged at the first end of the first stent graft portion; when the second stent graft portion is at the proximal end, the positioning bracket is arranged at the second end of the second stent graft portion. When the first stent body is transported, the stent transporter is connected to the positioning bracket to transport the first stent body to the target position.

[0025] In some preferred embodiments, the positioning stent is provided with a barb to prevent the first stent body from being displaced after being impacted by blood flow in the aorta. Similarly, a barb may also be provided at the first end of the first coated stent part or the second end of the second coated stent part.

[0026] In some preferred embodiments, when the number of the first coated stent channels provided in the first coated stent portion or the second coated stent portion is plural, the multiple first coated stent channels are arranged in parallel with each other. Specifically, the number of the first coated stent channels in the first coated stent portion can be zero, one, two, three, and so on; the number of the first coated stent channels in the second coated stent portion can also be zero, one, two, three, and so on. The number of first coated stent channels is determined according to the placement position of the stent and the doctor's usage habits, and the total number of first coated stents in the first stent body is also consistent with the number of branch artery pathways that need to be reconstructed.

[0027] In some preferred embodiments, when the one end of the first coated stent channel is flush with the first end of the first coated stent portion or the second end of the second coated stent portion, the blocking film is in a planar shape and / or when the end of the first coated stent channel is located inside the first coated stent portion or the second coated stent portion, the blocking film is in a planar shape or an inclined surface shape (funnel shape). In other words, the end of the first coated stent channel away from the branch artery may be flush or not flush with the end point of the first coated stent portion or the second coated stent portion away from the bare stent portion, and the blocking film may be perpendicular or not perpendicular to the coating direction of the first or second coated stent portion. It should be emphasized that the inclined surface design is conducive to the blood flow entering the first coated stent channel, but the planar design will not hinder the blood flow entering the first coated stent channel.

[0028] In addition, when the present application is used for patients whose aortic lesions extend to the abdominal aorta area, it is also necessary to simultaneously complete the connection between the first stent body and the common iliac artery. Therefore, the present application also provides at least one second coated stent channel set in the first coated stent portion or the second coated stent portion, a portion of the second coated stent channel is set in the first coated stent portion or the second coated stent portion, and the other portion extends out of the first coated stent portion or the second coated stent portion away from the end of the bare stent portion and is connected to the corresponding artery (such as the iliac artery).

[0029] When the branch artery channel is reconstructed, in addition to flowing into the branch artery through the first opening, the blood flow can also freely flow inside and outside the first stent body through the second opening. At this time, the aortic lesion is not isolated from the blood flow, and the blood flow can also flow freely out of the first stent body. In other words, when the branch artery reconstruction auxiliary device provided by the present application is used to reconstruct the branch artery first aorta, blood can flow from the upstream of the aorta through the first stent body to the downstream of the aorta, and the human body will not fall into the risk of ischemia, and the blood in the artery is not isolated from the lesion.

[0030] The present application also provides a branch artery reconstruction auxiliary device, comprising an occluding membrane and a first stent body for blood to flow through;

[0031] The first stent body comprises a first coated stent portion, a bare stent portion and a second coated stent portion which are connected in sequence;

[0032] A plurality of blood flow channels are respectively provided in the first coated stent part and the second coated stent part, some of the blood flow channels flow in the bare stent part, and some of the blood flow channels flow outside the bare stent part;

[0033] The occluding membrane is disposed in the first stent graft portion and the second stent graft portion and is configured to close the gaps between the plurality of blood flow channels. Blood can flow into the branch artery through the blood flow channels, and can also flow from the first stent graft portion to the second stent graft portion through the bare stent portion.

[0034] The present application also provides a SC (Superior Channel) branch-priority aorta reconstruction system, comprising a branch artery reconstruction auxiliary device as described in any of the preceding ones and a second stent body; the second stent body is a coated stent body, which is used to be implanted into the first stent body to complete the isolation of the lesion after the first stent body is positioned and released and the branch artery coated stent is implanted to complete the branch artery reconstruction.

[0035] In some preferred embodiments, there is a positioning mark only on the first bracket body, or there is a positioning mark only on the second bracket body, or there are positioning marks on the first bracket body and the second bracket body respectively.

[0036] The positioning mark is used for positioning under X-ray, so as to assist in determining the position of the stent during surgery. The positioning mark can be set at any position of the first stent body, such as the distal end. The positioning mark can also be at all positions of the first stent body. Similarly, the positioning mark can be set at any position of the second stent body, such as the distal end. The positioning mark can also be at all positions of the second stent body.

[0037] The SC branch-priority aorta reconstruction system provided in the present application also includes a branch artery covered stent connected to the first covered stent channel and / or the second covered stent channel.

[0038] In some preferred embodiments, the diameter of the branch artery stent graft is gradually changed; preferably, the diameter of one end of the branch artery stent graft connected to the first stent graft channel or the second stent graft channel is smaller than the diameter of the other end; or the diameter of one end of the branch artery stent graft connected to the first stent graft channel or the second stent graft channel is larger than the diameter of the other end. It should be noted that the gradual change of diameter is not limited to the above-mentioned situations, and it shall be based on the specific needs in clinical practice.

[0039] In some preferred embodiments, a leak-proof channel is respectively provided in the first coated stent portion and the second coated stent portion, one end of the leak-proof channel is connected to the second opening, and the other end of the leak-proof channel is connected to the second stent body. When the leak-proof channel is connected to the second stent body, it is preferably sleeved, that is, the connection between the leak-proof channel and the second stent body overlaps. After the branch artery pathway is reconstructed using the first coated stent channel, the second stent body is placed in the first stent body, and the two ends of the second stent body are connected to the leak-proof channel. The blood flows from the leak-proof channel at one end of the first stent body into the second stent body, and then into the other end of the first stent body until it flows out of the first stent body. At this time, the SC branch priority aorta reconstruction system provided in the present application successfully reconstructs the body's aortic pathway. It is worth mentioning that at this time, the blood flow is isolated from the lesion in the branch artery area, and the blood flow can flow from the upstream aorta through the first coated stent channel into the branch artery, and through the second stent body into the downstream aorta.

[0040] In some preferred embodiments, the length of the second stent body is greater than the length of the bare stent portion of the first stent body.

[0041] In order to facilitate the anchoring of the second stent body in the first stent body, a barb is provided at one or both ends of the second stent body. It can be understood that a first barb is provided at the proximal end of the second stent body so that the second stent body is buckled on the first stent body, and a second barb can also be provided at the distal end of the second stent body at the same time. Or only the first barb is provided at the proximal end of the second stent body. The second stent body can be fixed on the inner wall of the anti-leakage channel of the first stent body of the blood vessel under the impact of high-speed and high-pressure blood flow in the aorta.

[0042] Similar to the first bracket body, a positioning bracket is also provided at one end of the second bracket body for connecting with a bracket conveyor to facilitate conveying the second bracket body to a predetermined position.

[0043] In some preferred embodiments, the diameter of the second stent body after being released is equal to or greater than the inner diameter of the leakage-proof channel, so as to improve the sealing performance between the second stent body and the leakage-proof channel.

[0044] In the first stent graft portion, the first opening is arranged on one side of the occluding membrane, and the second opening is arranged on the other side of the occluding membrane.

[0045] In the second stent graft portion, the first opening is arranged at a position close to a side wall of the second stent graft portion, and the second opening is arranged at a middle position of the occluding membrane.

[0046] From the above, it can be seen that the branch artery reconstruction auxiliary device provided in the present application can insert a first stent body into the body when the blood in the aorta is unobstructed to complete the branch priority reconstruction step, and the SC branch priority aortic reconstruction system is used in combination with the first stent body. The first stent body is first set in the aorta, and the aorta-branch blood flow channel is jointly constructed by the embedded stent and the branch artery covered stent set in the branch artery to achieve the branch reconstruction priority step (by performing branch artery priority reconstruction, it can to a certain extent solve the common problems of complex structure, bleeding and low patency rate of stents used to treat multi-branch aortic diseases). After the branch artery pathway is reconstructed, the second stent body is sleeved on the leak-proof channel of the first stent body to jointly construct the aorta-aorta blood flow channel. The second stent body is sealed and cooperated with the first stent body to isolate the lesion, the stent does not leak internally, and all arteries are unobstructed. The cerebral blood flow and / or organ blood flow are normally supplied during the operation, avoiding blood flow blockage, thereby reducing complications caused by ischemia.

[0047] Compared with the prior art, the advantages of this application are:

[0048] 1. This application is used to isolate aortic dissection or aneurysm cavity to avoid endoleak;

[0049] 2. The reconstruction of branches and the isolation of lesions during surgery are divided into two steps: first, the first stent is used to establish the blood supply of the three-branch artery of the aortic arch or the four-branch artery of the visceral artery of the thoracic and abdominal aorta, and then the second stent is implanted to isolate the lesions of the aortic arch or the thoracic and abdominal aorta, which solves the problem of maintaining blood supply and avoiding ischemia during the surgery of reconstructing branch blood vessels;

[0050] 3. The present application establishes a branch channel in an open state without ischemia, avoiding the complicated steps of pre-opening windows on the coated stent or opening windows in situ after implantation in the prior art, as well as organ ischemia caused by long-term surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] In order to more clearly illustrate the technical solutions in the present application or related technologies, the drawings required for use in the embodiments or related technical descriptions are briefly introduced below. Obviously, the drawings described below are only embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0052] Figure 1a This is a schematic structural diagram of a first stent body before use in the SC branch priority aortic arch reconstruction system according to an embodiment of the present application;

[0053] Figure 1bThis is a schematic structural diagram of the second stent body before use in the SC branch priority aortic arch reconstruction system according to an embodiment of the present application;

[0054] Figure 2 A schematic structural diagram of a first stent body and a second stent body used in combination in a SC branch priority aortic arch reconstruction system according to an embodiment of the present application;

[0055] Figure 3 This is a schematic structural diagram of a first stent body being arranged in the aortic arch in the SC branch priority aortic arch reconstruction system according to an embodiment of the present application;

[0056] Figure 4a It is a cross-sectional schematic diagram of a first coated stent portion of a first stent body in the SC branch priority aortic arch reconstruction system according to an embodiment of the present application;

[0057] Figure 4b It is a schematic diagram of the proximal end portion of the first covered stent portion of the first stent body in the SC branch priority aortic arch reconstruction system according to an embodiment of the present application;

[0058] Figure 5a It is a cross-sectional schematic diagram of the second stent graft portion of the first stent body in the SC branch priority aortic arch reconstruction system according to an embodiment of the present application;

[0059] Figure 5b It is a schematic diagram of the distal end portion of the second stent graft portion of the first stent body in the SC branch priority aortic arch reconstruction system according to an embodiment of the present application;

[0060] Figure 6 It is a structural schematic diagram of the distal end of the first stent body and the second stent body after being used in combination in the SC branch priority aortic arch reconstruction system of the embodiment of the present application;

[0061] Figure 7a This is a schematic structural diagram of a first type of first stent body before use in the SC branch priority thoracic and abdominal aorta reconstruction system of an embodiment of the present application;

[0062] Figure 7b This is a schematic structural diagram of the second stent body before use in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0063] Figure 7c This is a schematic diagram of a second first stent body before use in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0064] Figure 7d This is a schematic diagram of a third first stent body before use in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0065] Figure 8a This is a schematic structural diagram of a first type of first stent body disposed in the thoracic and abdominal aorta in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0066] Figure 8b This is a structural schematic diagram of a first type of combination of a first stent body and a second stent body in a SC branch-first thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0067] Figure 8c This is a schematic structural diagram of a second type of first stent body disposed in the thoracic and abdominal aorta in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0068] Figure 8d This is a structural schematic diagram of a second type of combination of a first stent body and a second stent body in the SC branch priority thoracic and abdominal aorta reconstruction system of an embodiment of the present application;

[0069] Figure 8e This is a schematic structural diagram of a third first stent body disposed in the thoracic and abdominal aorta in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0070] Figure 8f This is a schematic structural diagram of a third type of combination of a first stent body and a second stent body used in the SC branch-first thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0071] Figure 9a This is a schematic structural diagram of the proximal end of the first stent body in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0072] Figure 9b for Figure 9a Schematic cross-sectional view of ;

[0073] Fig.10a This is a schematic structural diagram of the distal end of the first stent body in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0074] Fig.10b for Fig.10a Schematic cross-sectional view of ;

[0075] Fig.11a Another structural schematic diagram of the distal end of the second stent graft portion in the SC branch priority thoracic and abdominal aorta reconstruction system according to an embodiment of the present application;

[0076] Fig.11b for Fig.11a Schematic cross-section diagram of . DETAILED DESCRIPTION

[0077] In order to make the objectives, technical solutions and advantages of the present application more clearly understood, the present application is further described in detail below in combination with specific embodiments and with reference to the accompanying drawings.

[0078] It should be noted that, unless otherwise defined, the technical terms or scientific terms used in the embodiments of the present application should be the usual meanings understood by people with ordinary skills in the field to which the present application belongs. The "first", "second" and similar words used in the embodiments of the present application do not represent any order, quantity or importance, but are only used to distinguish different components. "Including" or "comprising" and similar words mean that the elements or objects appearing in front of the word cover the elements or objects listed after the word and their equivalents, without excluding other elements or objects. "Connect" or "connected" and similar words are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0079] In addition, the numerical values ​​mentioned in the embodiments of the present application are only for examples and are not intended to limit the technical features of the present application.

[0080] In the present application, the proximal end may be understood as an end close to the heart, and the distal end may be understood as an end relatively far from the heart.

[0081] Intracavitary treatment utilizes implanted covered stents (fenestrated stent implantation, branch artery covered stent implantation, chimney technology) to achieve minimally invasive repair without opening the chest and blocking blood flow, but the treatment must isolate the lesions while maintaining patency of blood vessels, and the operation is very difficult. The SC branch-priority aortic reconstruction system provided in the present application can achieve both isolation of lesions and patency of blood vessels, and specifically includes a branch artery reconstruction auxiliary device (i.e., a first stent body and a closure membrane) and a second stent body. It should be understood that when performing "branch-priority" aortic and branch artery reconstruction surgery, the branch artery reconstruction auxiliary device must be used first, and after the branch artery pathway is reconstructed, the second stent body is used as needed to reconstruct the aortic pathway. Since the SC branch-priority aortic reconstruction system includes the SC branch artery reconstruction auxiliary device, the following embodiments no longer describe the branch artery reconstruction auxiliary device separately.

[0082] The embodiment of the present application describes in detail the use of the SC branch-priority aortic reconstruction system for the aortic arch and part of the distal ascending aorta lesions or thoracic and abdominal aortic lesions as an example, but the present application is not limited to use in the aortic arch and thoracic and abdominal aorta. When used for other aortic lesions, it is only necessary to adjust the position and number of the first coated stent channel in the first coated stent part and the second coated stent part according to the position and number of the branch arteries, and the technical effect of preventing endoleak and ischemia of the present application can still be achieved.

[0083] In some embodiments, the SC branch-first aortic reconstruction system provided by the present application is a SC branch-first aortic arch reconstruction system, wherein 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 before the aortic access is reconstructed, the first stent body 20a and the second stent body 50a are separated, such as Figure 1a and Figure 1b As shown, during aortic reconstruction, the first stent body 20a and the second stent body 50a are combined together, as shown in FIG. Figure 2 and Figure 3 After being implanted in the aortic arch, the first stent body 20a and the second stent body 50a both straddle the aortic arch in a saddle shape, and the stability of their combination is much higher than that of other aortic branch artery covered stent systems.

[0084] In this embodiment, the first stent body 20a may have a hollow cavity, and the first stent body 20a includes a first covered stent part 21a and a second covered stent part 22a connected to the bare stent part 23a at both ends thereof. Before using the SC branch priority aorta reconstruction system provided by the present invention, blood flows in the human artery. After the first stent body 20a is released in the body and the body positioning is completed, blood can flow in the first stent body 20a, that is, from the proximal end of the first stent body 20a through the bare stent part 23a, the blood can flow in the first stent body 20a. 3a flows to the distal end of the first stent body 20a, that is, from the first end of the first coated stent portion 21a (the first coated stent portion can be the proximal end or the distal end, and in this embodiment it is set as the proximal end, so the first coated stent portion 21a is referred to as the proximal end coated stent portion 21a in the following text) to the second end of the second coated stent portion 22a (the second coated stent portion can be the proximal end or the distal end, and in this embodiment it is set as the distal end, so the second coated stent portion 22a is referred to as the distal end coated stent portion 22a in the following text). The first end here can be set at any position of the proximal coated stent portion 21a, such as the blood-facing end of the proximal coated stent portion 21a; the second end here can be set at any position of the distal coated stent portion 22a, such as the blood-facing end of the distal coated stent portion 22a, to prevent blood from forming a thrombus in the first stent body 20a. The first stent body 20a is an integral structure, that is, the proximal coated stent portion 21a, the bare stent portion 23a and the distal coated stent portion 22a are an integral structure. The proximal coated stent portion 21a and the distal coated stent portion 22a are coated stents, and the bare stent portion 23a is a bare stent. When the first stent body 20a is used for the aortic arch, the three branch arteries of the arch are not covered with a coating, and in the absence of ischemia, branch coated stents connected to the first stent body 20a are respectively inserted into the innominate, left common carotid and left subclavian arteries, such as Figure 3 As shown, the positions of the innominate artery branch artery covered stent 216, the common carotid artery branch artery covered stent 217 and the subclavian artery branch artery covered stent 218 relative to the bare stent portion 23a are roughly consistent with the positions of the openings of the innominate artery, the left common carotid artery and the left subclavian artery among the branch arteries on the aortic arch.

[0085] In some embodiments, three first stent graft channels are provided in the proximal stent graft portion 21a and the distal stent graft portion 22a (i.e., zero to three stent graft channels can be provided thereon according to the surgical habits of different doctors), and the first stent graft channels are respectively connected to the branch artery graft stents in the innominate artery, the common carotid artery, and the subclavian artery, wherein the branch artery graft stents pass through the metal wire mesh pores of the bare stent portion 23a. Similarly, it can also be provided that the first stent graft channel passes through the metal wire mesh pores of the bare stent portion 23a and is respectively connected to the branch artery graft stents in the innominate artery, the common carotid artery, and the subclavian artery. In this embodiment, two first stent graft channels are provided in the proximal stent graft portion 21a, and one first stent graft channel is provided in the distal stent graft portion 22a; those skilled in the art will know that the first stent graft channel on the distal stent graft portion 22a causes blood to flow into the channel and flow to the corresponding branch artery through a pressure difference.

[0086] The first stent graft channel can be formed by the corresponding coated embedded stent (211a, 212a, 221a); ​​wherein the coated embedded stent can include an embedded stent body with a cavity and a coating arranged outside the embedded stent body. That is, the first stent graft channel is formed by the cavity of the corresponding coated embedded stent. In some embodiments, two coated embedded stents can be arranged in the first coated stent portion 21a, namely the first coated embedded stent 211a and the second coated embedded stent 212a, and a coated embedded stent can be arranged in the distal end coated stent portion 22a, namely the third coated embedded stent 221a. When the first stent body 20a is arranged in the aortic arch, the reconstruction of the branch artery (i.e., the branch blood vessel) is achieved through the first coated embedded stent 211a, the second coated embedded stent 212a and the third coated embedded stent 221a, and the second stent body 50a is placed in the first stent body 20 to achieve the establishment of the aortic channel and the isolation of the lesions at the aortic arch. Thus, by using the first stent body 20a and the second stent body 50a in combination, the branch reconstruction priority step is implemented, so that the branch arteries are normal during the operation and the cerebral blood flow is normally supplied, blood flow blockage is avoided, and then cerebral ischemia is avoided, thereby reducing the incidence of cerebral infarction.

[0087] In some embodiments, in the radial direction, the size (i.e., diameter) of the first coated embedded stent 211a is slightly smaller than the deployed size of the innominate artery branch artery covered stent in the first overlapping region. The size of the second coated embedded stent 212a is slightly smaller than the deployed size of the common carotid artery branch artery covered stent 217 in the second overlapping region. The size of the third coated embedded stent 221a is slightly smaller than the deployed size of the subclavian artery branch artery covered stent 218.

[0088] In some embodiments, the first stent-graft embedded and the second stent-graft embedded may be elliptical or circular in shape, such as Figure 4a The sizes of the first covered embedded stent and the second covered embedded stent are adapted to the branch artery to be implanted.

[0089] In some embodiments, the shape of the third stent embedded in the coating 221a can be circular or elliptical, such as Figure 5a shown.

[0090] In some embodiments, the length of the embedded first coated embedded stent 211a, the second coated embedded stent 212a, and the third coated embedded stent 221a needs to be long enough to be nested and connected with the branch artery coated stent to avoid internal leakage due to too short overlapping area. These coated embedded stents can be partially arranged in the bare stent part 23a, and the corresponding left subclavian artery branch artery coated stent 218 and other branch artery coated stents in the branch arteries such as the left subclavian artery can be well placed in these coated embedded stents without gaps, and can fully fit with the inner wall of the coated embedded stent to ensure no bleeding, and each branch artery coated stent enters the bare stent part 23a from the metal mesh pores of the bare stent part 23a and is connected to the coated embedded stent.

[0091] It should be understood that the innominate artery branch artery covered stent may adopt an existing branch artery covered stent as long as it can be implanted in the corresponding artery branch.

[0092] In some embodiments, the distal end of the first coated embedded stent 211a is coaxially nested with the proximal end of the innominate artery branch artery covered stent; the distal end of the first coated embedded stent 211a has a first overlapping area that is nested with the proximal end of the corresponding innominate artery branch artery covered stent. The dimension of the first overlapping area in the axial direction (that is, the length of the first overlapping area) is greater than a preset 30 mm, and may also be greater than other preset values, 30 mm is only used as an example. Similarly, the distal ends of the second coated embedded stent 212a and the third coated embedded stent 221a are also coaxially nested accordingly, and a preset value is set in the overlapping area so that after the branch artery covered stent is released in the coated embedded stent, there is enough contact surface with the coated embedded stent to firmly connect with each other.

[0093] In some embodiments, Figure 6As shown, the length of the distal end coated stent portion 22a is greater than the overlapping portion of the third coated embedded stent 221a therewith, which ensures that the second stent body 50a has sufficient overlap with the first stent body 20a after being implanted into the first stent body 20a in the aortic arch, and will not cover the distal end of the embedded coated small stent (that is, the third coated embedded stent 221a) in the end coated portion of the first stent body 20a (that is, the distal end coated stent portion 22a). At the same time, when used in the thoracic and abdominal aorta, when the distal end of the first stent body 20a needs to extend the coated stent (that is, extend the distal end coated stent portion 22a), it will not cover the opening of the embedded small coated stent (that is, the third coated embedded stent 221a).

[0094] In some embodiments, the occluding membrane (219a, 229a) is arranged at the ends of the proximal coated stent portion 21a and the distal coated stent portion 22a. Specifically, a first occluding membrane 219a (hereinafter referred to as the proximal occluding membrane) is arranged at the end of the proximal coated stent portion 21a, and a second occluding membrane 229a (hereinafter referred to as the distal occluding membrane) is arranged at the end of the distal coated stent portion 22a; the proximal occluding membrane 219a can be arranged at any position of the proximal coated stent portion 21a, and the distal occluding membrane 229a can be arranged at any position of the distal coated stent portion 22a. It is only necessary to ensure that the placement position of the first stent body 20a after the operation can make the lesion part located between the proximal occluding membrane 219a and the distal occluding membrane 229a, and the blood flow in the patient's aorta will not contact the lesion part.

[0095] In some embodiments, the proximal end occluding membrane 219a is a membrane formed by sealing and suturing a circle along the circumferential direction of the proximal end coated stent part 21a on the coating of the proximal end coated stent part 21a. The proximal end occluding membrane 219a prevents the blood flow in the aorta from freely flowing into the first stent body 20a from the radial direction of the first stent body 20a. The suturing part can be on the inner wall or outer wall of the proximal end coated stent part 21a. Further, the first occluding membrane 219a is provided with a first opening 213, a first opening 214 and a second opening 215a, such as Figure 4a As shown, blood flow cannot flow into the first stent body 20a from the shaded area, and 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 with one end of the first coated embedded stent 211a, and the other end of the first coated embedded stent 211a is embedded with the innominate artery branch artery coated stent 216 to form a reconstructed blood flow channel of the innominate artery branch blood vessel. The edge of the first opening 214 is sutured with one end of the second coated embedded stent 212a, and the other end of the second coated embedded stent 212a is embedded with the common carotid artery branch artery coated stent 217 to form a reconstructed blood flow channel of the common carotid artery branch blood vessel.

[0096] In some embodiments, a second blocking film 229a is disposed in the radial direction within the distal end stent graft portion 22a. The second blocking film 229a is attached to the inner wall of the distal end stent graft portion 22a and has a first opening 222 and a second opening 223. Figure 5a and Figure 5b The first opening 222 is connected to a third coated embedded stent 221a nested with the subclavian artery branch artery coated stent 218 to form a blood flow channel for the reconstructed subclavian artery branch blood vessel. The second opening 223 is nested with a second stent body 50a, which will be described in detail later.

[0097] In some embodiments, when one end of the first stent graft channel is flush with the proximal edge of the proximal stent graft portion 21a, the first occluding film 219a is in a planar shape, or it can be said that it is arranged parallel to the radial direction of the proximal stent graft portion 21a, and the first opening (213, 214) is in the plane where the proximal end point of the proximal stent graft portion 21a is located; when one end of the first stent graft channel is located inside the proximal stent graft portion 21a, the first occluding film 219a is in an inclined shape, such as Figure 4b As shown, for example, it is in the shape of a funnel, and the first opening (213, 214) is inside the proximal end stent graft portion 21a. Similarly, when one end of the first stent graft channel is flush with the distal end edge of the distal end stent graft portion 22a, the second blocking film 229a is in a planar shape; when one end of the first stent graft channel is located inside the distal end stent graft portion 22a, the second blocking film 229a is in the shape of a funnel. It should be understood that the shapes of the first blocking film 219a and the second blocking film 229a are independently set, and may be the same or different.

[0098] In some embodiments, the first coated embedded stent 211a and the second coated embedded stent 212a are respectively arranged in the proximal coated stent portion 21a and adjacent to each other, and one end of the first coated embedded stent 211a and the second coated embedded stent 212a are arranged flush with the proximal end of the proximal coated stent portion 21a.

[0099] The third coated embedded stent 221a is disposed in close contact with the distal end coated stent portion 22a.

[0100] In the SC branch priority aortic arch reconstruction system provided in the embodiment of the present application, the first stent body portion is composed of three parts combined into a whole. Among them, the proximal end coated stent portion 21a is a coated stent and has a channel embedded with two sub-coated stents (such as the first coated embedded stent 211a and the second coated embedded stent 212a), and the front end (that is, the proximal end) of the proximal end coated stent portion 21a is provided with a positioning stent 24a, and the tip of the positioning stent 24a is designed to be inward-adducted to avoid the tip from piercing the ascending aorta wall. The distal end coated stent portion 22a is a coated stent and has a channel embedded with a sub-coated stent (such as the third coated embedded stent 221a), and the bare stent portion 23a connected in the middle is an arch-shaped bare stent.

[0101] In some embodiments, the positioning bracket 24a is further provided with a barb 241 ( Figure 1a (not shown) to better anchor the first stent body on the inner wall of the blood vessel. Similarly, a barb 241 ( Figure 1a not shown).

[0102] In some embodiments, the second stent body 50a is a coated stent, which is configured to be implanted in the first stent body 20a and placed parallel to the first coated stent channels in its two ends (i.e., the proximal coated stent portion 21a and the distal coated stent portion 22a) after the first stent body is set in the aortic arch (or thoracic and abdominal aorta) and completes the reconstruction of the branch artery, so as to cooperate with the first stent body 20a to isolate the lesion of the aorta.

[0103] In some embodiments, the occluding membrane is provided with a second opening (215, 223) for allowing blood to flow from the second opening 215 to the bare stent portion 23a, and to flow out of the second opening 223 from the bare stent portion 23a. Further, the proximal end of the second stent body 50a can be connected to the second opening 215, and the distal end of the second stent body 50a can be connected to the second opening 223, so that the first stent body 20a isolates the lesion 41 of the aortic arch or the lesion of the thoracic and abdominal aorta. Further, in order to facilitate the detachable placement of the first stent body 20a in the second stent body 50a, leak-proof channels are respectively provided in the proximal end coated stent portion 21a and the distal end coated stent portion 22a, one end of the leak-proof channel is connected to the second opening, and the other end of the leak-proof channel is connected to the second stent body 50a. That is, the second stent body 50a is used to be arranged in the bare stent portion 23a to connect the blood flow in the aorta after the branch artery is connected through the first stent body 20a.

[0104] In some embodiments, a first leak-proof channel 71a is provided in the proximal end coated stent portion 21a, and a second leak-proof channel 72a is provided in the distal end coated stent portion 22a. In this way, the second stent body 50a is detachably nested in the first leak-proof channel 71a and the second leak-proof channel 72a. One end (e.g., the proximal end) of the first leak-proof channel 71a is connected to the second opening 215 on the first blocking film 219a, and the other end (e.g., the distal end) of the first leak-proof channel 71a is abutted against the outer wall of the second stent body 50a. One end (e.g., the distal end) of the second leak-proof channel 72a is connected to the second opening 223 on the second blocking film 229a, and the other end (e.g., the proximal end) of the second leak-proof channel 72a is abutted against the outer wall of the second stent body 50a.

[0105] In some embodiments, the proximal end of the coated embedded stent in the proximal end coated stent portion 21a does not exceed the proximal end of the second stent body 50a. Figure 6 As shown, the linear distance between the proximal end of the third coated embedded stent 221a and the proximal end of the second stent body 50a does not exceed 10 mm; similarly, the distance between the distal end of the embedded stent in the distal end coated stent part 22a and the distal end of the second stent body 50a can also be set to be within 10 mm. In this way, it can be ensured that the two stent systems are firmly attached and no internal leakage occurs.

[0106] 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 on 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 so that the second stent body 50a fits firmly with the first stent body 20 without internal leakage.

[0107] In some embodiments, the radial direction of the second bracket body (50a, 50b) is relatively flexible, for example, it can be obtained by grinding the outer surface of the second bracket body (50a, 50b). The proximal end of the second bracket body (50a, 50b) is provided with a first barb 51a (corresponding to the first barb 51b on the second bracket body 50b) so that the second bracket body 50a (or the second bracket body 50b) is buckled on the first bracket body 20a (or the first bracket body 20b). The distal end of the second bracket body (50a, 50b) can be selectively provided with a second barb 52a (corresponding to the second barb 52b on the second bracket body 50b) so that the second bracket body 50a (or the second bracket body 50b) is better buckled on the first bracket body 20a (or the first bracket body 20b). In this way, the second bracket body (50a, 50b) and the first bracket body (20a, 20b) can be fully fitted and not shifted. This can better seal the bare stent portion 23a of the first stent body 20a and isolate the lesions of the aortic arch. After the second stent body 50a is implanted, a compliant balloon can be used to appropriately expand the second stent body 50a covered stent to ensure its sealing.

[0108] In some embodiments, the proximal end of the second stent body 50a may also have a positioning stent 53a, and the tip of the positioning stent 53a converges from the proximal end to the distal end to prevent the positioning stent 53a from damaging the aortic wall and facilitate the release of the second stent body 50a.

[0109] In some embodiments, the second opening 215a and the second opening 223a are respectively connected with the first leak-proof channel 71a and the second leak-proof channel 72a, and the front and rear ends of the second bracket body 50a are respectively detachably nested in the first leak-proof channel 71a and the second leak-proof channel 72a. The proximal end of the first leak-proof channel 71a is connected to the second opening 215a, and at the same time, in the proximal end coated bracket part 21a, the first part of the outer wall of the first leak-proof channel 71a is attached to the inner wall of the proximal end coated bracket part 21a; the second part of the outer wall of the first leak-proof channel 71a is attached to the outer wall of the first coated embedded bracket 211a and the second coated embedded bracket 212a. The distal end of the first anti-leakage channel 71a is connected to the second opening 223a. At the same time, in the distal end coated bracket part 22a, the first part of the outer wall of the second anti-leakage channel 72a is attached to the inner wall of the distal end coated bracket part 22a; the second part of the outer wall of the second anti-leakage channel 72a is attached to the outer wall of the third coated embedded bracket 221a.

[0110] In some embodiments, the first leakage-proof channel and the second leakage-proof channel may be formed by a covering film.

[0111] The SC branch priority aorta and branch artery reconstruction system provided in the embodiment of the present application, when in use, the first stent body 20a and the second stent body 50a are respectively implanted in the aortic arch. Among them, the first stent body 20a is first implanted in the aortic arch under the condition of opening to ensure cerebral circulation and blood supply, and the reconstruction of each blood vessel of each branch artery of the aortic arch is completed first, so that the blood supply of the three branch arteries of the aortic arch is reconstructed intact, and then the second stent body 50a is inserted into the first stent body 20a, so that the aortic channel can be established under the premise of blood flow isolation from the lesion site. At this point, the patency and sealing of the aorta and each branch artery are achieved, no blood leakage (to the lesion site), and the lesions at the aortic arch are isolated. Through the cooperation of the embedded channel of the first stent body 20a and the second stent body 50a, seamless sealing can be achieved at the proximal end and the distal end to avoid internal leakage. By maintaining blood circulation and avoiding ischemia during the reconstruction of the branches on the arch, the normal supply of cerebral blood flow during surgery is ensured, and cerebral ischemia is avoided, thereby reducing the incidence of cerebral infarction. After completing the branch reconstruction, the second stent body 50a is used to block and isolate the lesions in the proximal ascending main part, the middle arch part, and the distal descending main part; the operation is simple and avoids the complex modular connection steps; objectively avoids the difficulty of operation and the internal leakage between modules caused by inaccurate operation.

[0112] In some embodiments, the SC branch-prioritized aorta reconstruction system can be a SC branch-prioritized thoracoabdominal aorta reconstruction system, which is similar in structure to the SC branch-prioritized aortic arch reconstruction system. The aorta can include the thoracoabdominal aorta, and the branch arteries can be four-branch arteries of the thoracic and abdominal viscera, including the celiac trunk artery branch, the superior mesenteric artery branch, the left renal artery branch, and the right renal artery branch. The branch artery covered stent includes a celiac trunk artery 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-prioritized thoracoabdominal aorta reconstruction system includes a first stent body 20b, an occluding membrane, and a second stent body 50b. As shown in Figure 7~ Figure 8f As shown, they are schematic diagrams of the first stent body 20b and the second stent body 50b used separately and in combination. The first stent body 20b includes a bare stent portion 23b and a proximal coated stent portion 21b and a distal coated stent portion 22b connected by the bare stent portion 23b. After the first stent body 20b is implanted in the body, it crosses the two ends of the aorta involved in the lesion in the visceral artery branch area. The second stent body 50b is a coated stent body, which is configured to be nested in the bare stent portion 23b when the first stent body 20b is set in the visceral branch area of ​​the thoracic and abdominal aorta, so that the SC branch is preferentially isolated from the lesion in the visceral artery area by the aortic reconstruction system.

[0113] like Figure 8bAs shown, the relative positions of the celiac trunk artery 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 in the visceral artery branch area are respectively roughly consistent with the positions of the openings of the celiac trunk artery branch, the superior mesenteric artery branch, the left renal artery branch and the right renal artery branch in the branch arteries on the thoracic and abdominal artery branch area.

[0114] In some embodiments, a coated embedded stent can be provided in the proximal coated stent portion 21b, and three coated embedded stents can be provided in the distal coated stent portion 22b, so that a superior mesenteric artery branch channel can be constructed through blood reflux in the coated embedded stent in the distal coated stent portion 22b.

[0115] In some embodiments, two coated embedded stents may be respectively disposed in the proximal coated stent portion 21b and the distal coated stent portion 22b, such as Figure 7a As shown, the first coated embedded stent 211b and the second coated embedded stent 212b in the proximal coated stent portion 21b are adjacently arranged and located on one side of the first anti-leakage channel 71b. The third coated embedded stent 221b and the fourth coated embedded stent 226 in the distal coated stent portion 22b are respectively arranged on opposite sides of the second anti-leakage channel 72b in the distal coated stent portion 22b.

[0116] In some embodiments, a proximal end occluding film 219b is disposed in the radial direction within the proximal end coated stent portion 21b, the proximal end occluding film 219b is attached to the inner wall of the proximal end coated stent portion 21b, and a first opening 213b, a first opening 214b, and a second opening 215b are provided on the proximal end occluding film 219b to form a plurality of blood flow channels, such as Figure 9a As shown; the first opening 213b is sutured with the fourth coated embedded stent 211b, and the fourth coated embedded stent 211b can pass through the bare stent portion 23b, and is nested with the celiac artery branch artery coated stent 61 to form a reconstructed celiac artery pathway; the first opening 214b is sutured with the fifth coated embedded stent 212b, and the fifth coated embedded stent 212b and the superior mesenteric artery branch artery coated stent 62 are nested to form a reconstructed blood flow channel of the superior mesenteric artery branch blood vessel; the second opening 215b is connected with the first leak-proof channel 71b, and the first leak-proof channel 71b extends to the bare stent portion 23b, and blood can flow from the second opening 215b to the bare stent portion 23b.

[0117] In some embodiments, a distal end blocking film 229b is provided in the distal end stent graft portion 22b in the radial direction, and the distal end blocking film 229b is attached to the inner wall of the distal end stent graft portion 22b, and the distal end blocking film 229b is provided with a first opening 222b, a first opening 25, and a second opening 223b. Figure 9b As shown; accordingly, the first opening 222b is sutured with the sixth coated embedded stent 221b, and the blood flows into the sixth coated embedded stent 221b through the first opening 222b, and then flows into the left renal artery branch artery coated stent 63 nested with the sixth coated embedded stent 221b; the first opening 25 is connected to the seventh coated embedded stent 226, and the seventh coated embedded stent 226 is sleeved on the outer wall of the right renal artery branch artery coated stent 64 to form a blood flow channel for the reconstructed right renal artery branch blood vessel; in some embodiments, the second opening 223b is connected with a second leak-proof channel 72b, and the second leak-proof channel 72b extends to the bare stent portion 23b, and blood can flow from the second opening 223b to the bare stent portion 23b. The second bracket body 50b is nested inside the first and second leakproof membranes, that is, both ends of the second bracket body 50b are detachably connected to the first and second leakproof membranes to connect the proximal and distal ends of the first bracket body 20b.

[0118] In this way, the blood flow channels of the celiac trunk artery branches, the superior mesenteric artery branches and the bilateral renal artery branches can be reconstructed in a non-ischemic state, thus completing the blood supply reconstruction of the four-branch arteries of the thoracic and abdominal viscera.

[0119] In some embodiments, within the proximal coated stent portion 21b, a portion of the outer wall of the first anti-leakage membrane is in contact with the inner wall of the proximal coated stent portion 21b; and another portion of the outer wall of the first anti-leakage membrane is in contact with the outer walls of the fifth coated embedded stent 212b and the fourth coated embedded stent 211b. Within the distal coated stent portion 22b, a portion of the outer wall of the second anti-leakage membrane is in contact with the inner wall of the distal coated stent portion 22b; and a portion of the outer wall of the second anti-leakage membrane is in contact with the outer walls of the sixth coated embedded stent 221b and the seventh coated embedded stent 226.

[0120] In some embodiments, Fig.10a and Fig.10bAs shown, the sixth coated embedded stent 221b and the seventh coated embedded stent 226 are distributed in the positions of the two symmetrical sides of the distal end coated stent part 22b. That is, the sixth coated embedded stent 221b and the seventh coated embedded stent 226 are respectively fitted and arranged on the two opposite sides of the radial direction in the distal end coated stent part 22b. The sixth coated embedded stent 221b and the seventh coated embedded stent 226 can be independently circular or elliptical. The sixth coated embedded stent 221b and the seventh coated embedded stent 226 can respectively protrude slightly from the proximal end coated stent part 21b and enter the bare stent part 23b area (for example, the length entering the bare stent part 23b area can be about 5mm) to better nest with the left renal artery branch artery coated stent 63 and the right renal artery branch artery coated stent 64. Of course, this is only an example, and does not mean that only the sixth coated embedded stent 221b and the seventh coated embedded stent 226 can slightly protrude from the proximal coated stent portion 21b.

[0121] Specifically, the material of the coating in each coated stent may be polytetrafluoroethylene, etc. The material of each blocking membrane and leak-proof channel may be the same as that of the coating. Each coating may be sutured on the stent. The shapes of each leak-proof channel may be the same or different, for example, they may all be annular leak-proof membranes, sutured to the surface of adjacent coatings and coatings and adjacent stents in a sleeve-like manner.

[0122] In some embodiments, Figure 7c and Figure 7d As shown, the distal end of the first stent body 20b is also provided with a distal end stent graft extension section 67, and the distal end of the distal end stent graft extension section 67 is connected to a second stent graft channel (224, 225); the second stent graft channel (224, 225) is connected to the external iliac artery branch artery graft stent 65 and the internal iliac artery branch artery graft stent 66 respectively. The second stent graft channels (224, 225) are respectively fitted in the distal end stent graft extension section 67 and arranged adjacently and in parallel, the distal end of the second stent graft channel 224 is coaxially nested with the proximal end of the external iliac artery branch artery graft stent 65; the distal end of the second stent graft channel 225 is coaxially nested with the proximal end of the external iliac artery branch artery graft stent 65. In this way, reconstruction of the aorta and branch arteries extending from the aortic lesions to the abdominal aorta region can be achieved.

[0123] In some embodiments, Fig.11a and Fig.11bAs shown, the proximal end of the second coated stent channel 224 and the adjacent side walls of the proximal end of the second coated stent channel 225 are fitted together; the proximal end of the second coated stent channel 224 and the non-adjacent side walls of the proximal end of the second coated stent channel 225 are fitted together with the inner wall of the second coated stent extension section 67. It can be understood that the proximal end of the second coated stent channel 224 and the proximal end of the second coated stent channel 225 (facing the blood flow direction) are kissed and sutured together to form a double "D" shape to ensure a leak-free seal and gradually and naturally transition to an elliptical or circular shape at the distal end. In this way, the second coated stent channel 224 and the second coated stent channel 225 and the distal end stent extension section are sutured with the film without a gap to ensure that no bleeding occurs.

[0124] In some embodiments, in the radial direction, the distal end size of the second coated stent channel 224 is the same as the proximal end size of the branch artery coated stent of the external iliac artery 65; the distal end size of the second coated stent channel 225 is the same as the proximal end size of the branch artery coated stent of the internal iliac artery 66.

[0125] In some embodiments, Figure 8c and Figure 8d As shown, the proximal end of the external iliac artery branch artery covered stent 65 is nested in the distal end of the second covered stent channel 224 ; the proximal end of the internal iliac artery branch artery covered stent 66 is nested in the distal end of the second covered stent channel 225 .

[0126] In some embodiments, Figure 7d As shown, in the axial direction, the size of the second stent graft channel 224 is smaller than the size of the second stent graft channel 225. Figure 8e and Figure 8f As shown, the proximal end of the external iliac artery branch artery covered stent 65 is nested in the distal end of the second covered stent channel 224 ; the proximal end of the internal iliac artery branch artery covered stent 66 is nested in the distal end of the second covered stent channel 225 .

[0127] The SC branch priority thoracic and abdominal aorta reconstruction system provided in the embodiment of the present application is divided into two sets and implanted separately. The first stent body preferentially completes the reconstruction of the branch blood vessels while opening to ensure the circulation and blood supply of the internal organs; the second stent body cooperates with the first stent body to complete the establishment of the aortic channel and isolate the lesions in the branch artery area. The first stent body is divided into three parts combined into a whole. The proximal end coated stent part 21b is a coated stent and is embedded with two adjacent coated stents (i.e., the first coated embedded stent 211b and the second coated embedded stent 212b). The tip of the positioning stent 53a of the proximal end coated stent part 21b is designed to be inward-adducted to avoid the tip from stabbing the ascending aorta wall, and the front end coated outer edge of the proximal end coated stent part 21b is sewn with a hook to prevent displacement. The distal end coated stent part 22b is embedded with two symmetrical coated stents (i.e., the third coated embedded stent 221b and the fourth coated embedded stent 226), and the middle connecting part (i.e., the bare stent part 23b) is a sparse mesh bare stent. In the coated stent part of the first stent body (including the proximal coated stent part 21b and the distal coated stent part 22b), its embedded branch channel is sutured with the main coated stent to ensure a gap-free seal, and its inner-facing part maintains a regular elliptical shape with the main coated stent, thereby forming a seamless match with the implanted second stent body coated stent to achieve the purpose of proximal sealing. The second stent body is used to seal and isolate lesions, and is radially flexible, and has barbs at both proximal and distal ends to prevent displacement, ensuring seamless attachment and firm combination with the first stent body coated stent with the embedded channel at the proximal end.

[0128] The SC branch priority thoracic and abdominal aorta reconstruction system provided in the embodiment of the present application, when in use, is conceptually to implant the first stent body 20b and the second stent body 50b successively into the visceral branch area of ​​the thoracic and abdominal aorta with lesions. Among them, the first stent body 20b is first implanted into the aortic visceral artery under the condition of opening to ensure normal blood supply to the visceral organs, and then the covered stents of each branch artery are implanted respectively, so as to preferentially complete the reconstruction of each blood vessel of each branch artery of the aortic visceral artery; then the second stent body 50b is implanted into the first stent body 20b, overlapping and covering with the first stent body 20b, and isolating the lesions of the thoracic and abdominal aorta. Through the cooperation of the first stent body 20b and the second stent body 50b, seamless sealing can be achieved at the proximal end and the distal end to avoid internal leakage. During the reconstruction of the aortic visceral artery branches, the entrances of the visceral artery branches are all in the bare stent part 23b without the covering film. In the non-ischemic state, the covered embedded stents are respectively connected with the celiac artery, the superior mesenteric artery, and the left and right renal arteries and the branch covered stents are implanted. After completing the blood supply reconstruction of the four thoracic and abdominal visceral arteries, the blood circulation is maintained to avoid ischemia, and the normal cerebral blood flow supply during the operation is ensured to avoid ischemia. Then, the softer second stent body 50b is inserted to overlap with the first stent body 20b to achieve the sealing of the lesions in the visceral artery area and ensure the patency of each branch, thereby reducing the incidence of complications. After the reconstruction of the branches is completed, the second stent body 50b is used to block and isolate the lesions in the proximal ascending main part, the middle arch part, and the distal descending main part; the operation is simple, avoiding the complex modular connection steps; objectively avoiding the difficulty of operation and the connection leakage between modules caused by imprecise operation.

[0129] Those skilled in the art should understand that the discussion of any of the above embodiments is merely illustrative and is not intended to imply that the scope of the present disclosure (including the claims) is limited to these examples. Based on the concept of the present disclosure, the technical features in the above embodiments or different embodiments may be combined, the steps may be implemented in any order, and there are many other variations of the different aspects of the embodiments of the present disclosure as described above, which are not provided in detail for the sake of simplicity.

[0130] While the disclosure has been described in conjunction with specific embodiments thereof, many alternatives, modifications and variations of these embodiments will be apparent to those skilled in the art in light of the foregoing description.

[0131] The embodiments of the present disclosure are intended to cover all such substitutions, modifications and variations that fall within the broad scope of the appended claims. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the embodiments of the present disclosure should be included in the scope of protection of the present disclosure.

Claims

1. A SC branch-first aortic reconstruction system, characterized in that: It comprises a branch artery reconstruction auxiliary device and a second stent body; the branch artery reconstruction auxiliary device comprises a first stent body, the first stent body comprises a bare stent portion in the middle and a coated stent portion connected to both ends of the bare stent portion, and a blocking film arranged on the coated stent portion, at least one first coated stent channel is arranged in the coated stent portion, the blocking film has a second opening and at least one first opening, each of the first openings is correspondingly connected to a coated stent channel, and a channel formed by connecting any one end of the first coated stent channel with the corresponding branch artery coated stent passes through the pore gap of the bare stent portion; the first coated stent channel is formed by a corresponding coated embedded stent, the coated embedded stent comprises an embedded stent body with a cavity and a coating arranged outside the embedded stent body; the second opening of the blocking film is connected to the second stent body; the second stent body is a coated stent, which is used to be implanted into the first stent body to complete the isolation of the lesion after the first stent body is positioned and released and the branch artery coated stent is implanted to complete the reconstruction of the branch artery.

2. The SC branch-first aortic reconstruction system according to claim 1, characterized in that: The first opening is connected to one end of the first stent graft channel.

3. The SC branch-first aortic reconstruction system according to claim 2, characterized in that: When the one end of the first coated stent channel is located at the end surface of the coated stent portion, the blocking film is planar; and / or when the one end of the first coated stent channel is located inside the coated stent portion, the blocking film is planar or inclined.

4. The SC branch-first aorta reconstruction system according to claim 1, characterized in that: The occluding membrane is arranged at the blood-facing end of the coated stent portion.

5. The SC branch-first aortic reconstruction system according to claim 1, characterized in that: At least one second stent graft channel is disposed in the stent graft portion, a portion of the second stent graft channel is disposed in the stent graft portion, and another portion extends out of the stent graft portion and communicates with a corresponding branch artery.

6. The SC branch-first aorta reconstruction system according to claim 5, characterized in that: It also includes a branch artery covered stent connected to the first covered stent channel and / or the second covered stent channel.

7. The SC branch-first aorta reconstruction system according to claim 6, characterized in that: The diameter of the branch artery covered stent changes gradually.

8. The SC branch-first aorta reconstruction system according to claim 5, characterized in that: In the stent graft portion, the first opening is disposed at a position close to a side wall of the second stent graft channel, and the second opening is disposed at a middle position of the occluding membrane.

9. The SC branch-first aorta reconstruction system according to claim 1, characterized in that: A leak-proof channel is provided in the coated stent portion, one end of the leak-proof channel is connected to the second opening, and the other end of the leak-proof channel is connected to the second stent body in an overlapping manner.

10. The SC branch-first aorta reconstruction system according to claim 1, characterized in that: In the stent graft portion, the first opening is arranged on one side of the occluding membrane, and the second opening is arranged on the other side of the occluding membrane.

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