Aortic stent graft system and device for reconstructing upper branch of aortic arch

Abstract

The invention discloses an aortic stent graft system and device for reconstructing an aortic arch upper branch, and relates to the technical field of medical instruments. The branch stent is arranged close to the proximal end of the main stent and is used for reconstructing a head-arm trunk artery; the net-shaped window structure is arranged at the telecentric end, close to the starting part of the branch stent, of the side wall of the main stent, and the net-shaped window structure is used for follow-up operation of reconstructing the left subclavian artery; a window structure is formed in the side wall of the main body stent, is located between the branch stent and the net-shaped window structure and is used for arranging a short stent, and the short stent is used for reconstructing the left common carotid artery. An aorta disease lesion part can be repaired through a total femoral artery approach, the near-end anchoring area is moved forwards to the brachial trunk artery, and the brachial trunk artery, the left common carotid artery and the left subclavian artery are subjected to intracavitary reconstruction which completely conforms to a physiological anatomical structure and is along the blood flow direction by being combined with the integrated single branch stent in a telescopic mode.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an aortic stent-graft system and device for reconstructing the upper branches of the aortic arch. BACKGROUND

[0002] Due to the special structure of the aortic arch, it has been regarded as a "forbidden zone" for endovascular treatment for a long time. When the patient's lesion site involves the aortic arch, traditional open surgery or hybrid surgery is usually adopted for treatment, but the surgery is traumatic, time-consuming and has a high incidence of perioperative complications.

[0003] In recent years, with the development of aortic minimally invasive intervention technology, endovascular treatment technologies and products for aortic arch lesions have emerged in an endless stream. Among them, parallel stents and fenestration technology are the most widely used, but problems such as obstruction of normal blood flow in the arch and postoperative leakage cannot be solved. The advent of single-branch stents provides the best endovascular solution for patients with lesions involving the left subclavian artery, but it cannot handle more proximal lesions in the aorta. At this time, three-branch inlaid stents appear in the clinic, but due to their complex placement technology and reversal of the normal blood flow direction of the branches, they have not been widely used in the clinic.

[0004] For patients with dissection or aneurysm lesions involving the brachiocephalic trunk artery of the aortic arch, a safe, reliable and easy-to-operate total endovascular repair device is urgently needed. SUMMARY

[0005] The purpose of the present application is to provide an aortic stent-graft system and device for reconstructing the upper branches of the aortic arch, which can achieve reconstruction of the brachiocephalic trunk artery and the left common carotid artery.

[0006] To achieve the above-mentioned purpose, the present application provides the following solutions:

[0007] The present application provides an aortic stent-graft system for reconstructing the upper branches of the aortic arch, comprising: a main body stent, a branch stent, a window structure, a short branch stent and a mesh empty window structure; the main body stent is a hollow covered stent structure for treating the lesion site of aortic disease; the branch stent is arranged near the proximal end of the main body stent, one end of the branch stent is connected to the side wall of the main body stent, and is used for reconstruction of the brachiocephalic trunk artery; the mesh empty window structure is arranged on the side wall of the main body stent near the distal end of the starting part of the branch stent, and corresponds to the position of the left subclavian artery, and is used for subsequent reconstruction of the left subclavian artery; the side wall of the main body stent is provided with the window structure, the window structure is located between the branch stent and the mesh empty window structure, the window structure is used for arranging the short branch stent, and the short branch stent is used for reconstruction of the left common carotid artery.

[0008] In some specific embodiments, the main stent is internally hollow, and the proximal end of the main stent and the distal end of the main stent are provided with openings; the main stent comprises a stent body and a covering film, and the covering film is arranged on the outer surface of the stent body.

[0009] In some specific embodiments, the proximal end of the main stent is provided with a first inner side identification structure and a first outer side identification structure, and the distal end of the main stent is provided with a second inner side identification structure and a second outer side identification structure; the first inner side identification structure and the second inner side identification structure are used to identify the inner side of the main stent, and the first outer side identification structure and the second outer side identification structure are used to identify the outer side of the main stent.

[0010] The proximal end of the main stent is also provided with two position identification structures for identifying whether the main stent is twisted and rotated, the two position identification structures are oppositely arranged, and each position identification structure is located between the first inner side identification structure and the first outer side identification structure.

[0011] In some specific embodiments, the branch stent is internally hollow, and one end of the branch stent and the other end of the branch stent are provided with openings, and one end of the branch stent is sutured to the side wall of the main stent.

[0012] In some specific embodiments, the branch stent is provided with a first proximal end identification structure, a second proximal end identification structure, a third proximal end identification structure, a fourth proximal end identification structure, a first distal end identification structure and a second distal end identification structure; the first proximal end identification structure is used to identify the side of the proximal end of the branch stent close to the proximal end of the aorta, the second proximal end identification structure is used to identify the side of the proximal end of the branch stent close to the distal end of the aorta, the third proximal end identification structure and the fourth proximal end identification structure are used to identify the proximal end of the branch stent, the first distal end identification structure is used to identify the side of the distal end of the branch stent close to the proximal end of the aorta, and the second distal end identification structure is used to identify the side of the distal end of the branch stent close to the distal end of the aorta.

[0013] In some specific embodiments, the size of the window structure is smaller than the size of the origin of the left common carotid artery projecting onto the aorta; the short stent includes a short stent body and a short stent cap structure. The short stent body is hollow inside, and both one end and the other end of the short stent body have openings. The short stent cap structure is located at one end of the short stent body, and its inner side is connected to one end of the short stent body. The other end of the short stent body can pass through the window structure. The size of the short stent cap structure is larger than the size of the window structure. The short stent cap structure cooperates with the window structure to restrict the position of the short stent body.

[0014] In some specific solutions, the window structure is provided with a first starting recognition structure, a second starting recognition structure, a third starting recognition structure and a fourth starting recognition structure. The first starting recognition structure is used to identify the proximal end of the window, the second starting recognition structure is used to identify the distal end of the window, and the third starting recognition structure and the fourth starting recognition structure are arranged opposite to each other and are used to identify the horizontal boundary of the window.

[0015] The short stent body is provided with a first short stent proximal identification structure, a second short stent proximal identification structure, a third short stent proximal identification structure, a fourth short stent proximal identification structure, a first short stent distal identification structure, and a second short stent distal identification structure. The first short stent proximal identification structure is used to identify the side of the short stent proximal end that is close to the proximal end of the aorta. The second short stent proximal identification structure is used to identify the side of the short stent proximal end that is close to the distal end of the aorta. The third and fourth short stent proximal identification structures are used to identify the proximal end of the short stent. The first short stent distal identification structure is used to identify the side of the short stent distal end that is close to the proximal end of the aorta. The second short stent distal identification structure is used to identify the side of the short stent distal end that is close to the distal end of the aorta.

[0016] The short stent cap brim structure is provided with a first cap brim recognition structure, a second cap brim recognition structure, a third cap brim recognition structure and a fourth cap brim recognition structure on its outer side. The first cap brim recognition structure is used to identify the side of the cap brim that is close to the proximal end of the aorta. The second cap brim recognition structure is used to identify the side of the cap brim that is close to the distal end of the aorta. The third cap brim recognition structure and the fourth cap brim recognition structure are used to identify the edge of the short stent cap brim structure.

[0017] In some specific designs, the size of the mesh-like window structure is larger than the size of the origin of the left subclavian artery projected onto the aorta; the mesh-like window structure is made of woven mesh wires, and the mesh wires are provided with knots that are slidably connected to the mesh wires.

[0018] In some specific solutions, the edges of the mesh window structure are provided with a first edge recognition structure, a second edge recognition structure, a third edge recognition structure and a fourth edge recognition structure. The first edge recognition structure is used to identify the proximal end of the mesh window structure, the second edge recognition structure is used to identify the distal end of the mesh window structure, and the third edge recognition structure and the fourth edge recognition structure are arranged opposite to each other to identify the lateral boundary of the mesh window structure.

[0019] The present invention also provides an aortic stent graft device for reconstructing the supra-aortic branch, comprising a first stent delivery system and the aortic stent graft system for reconstructing the supra-aortic branch, wherein the first stent delivery system is used to deliver and release the aortic stent graft system for reconstructing the supra-aortic branch to a predetermined location.

[0020] The present invention achieves the following technical effects compared to the prior art:

[0021] This invention relates to a branched stent for the reconstruction of the brachiocephalic trunk. A window structure is located between the branched stent and a mesh-like window structure. The window structure is used to place short branch stents for the reconstruction of the left common carotid artery. The mesh-like window structure corresponds to the left subclavian artery and reserves space for subsequent reconstruction of the left subclavian artery. This invention can repair lesions via a femoral artery approach, moving the proximal anchoring zone anteriorly to the brachiocephalic trunk. Used in conjunction with an integrated single-branched stent in a nested configuration, it can perform endovascular reconstruction of the three branches of the aortic arch—the brachiocephalic trunk, left common carotid artery, and left subclavian artery—completely conforming to physiological anatomy and following the blood flow direction. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a front view of an aortic stent graft system for reconstructing supra-aortic branches according to some embodiments of the present invention;

[0024] Figure 2This is a top-view axonometric view of an aortic stent graft system for reconstructing supra-aortic branches according to some embodiments of the present invention.

[0025] Figure 3 This is a side view of an aortic stent graft system for reconstructing supra-aortic branches according to some embodiments of the present invention;

[0026] Figure 4 This is a schematic diagram of the mesh window structure in some embodiments of the present invention;

[0027] Figure 5 This is an isometric view of a short support in some embodiments of the present invention;

[0028] Figure 6 This is a front view of a short support bracket in some embodiments of the present invention;

[0029] Figure 7 This is a side view of a short support bracket in some embodiments of the present invention;

[0030] Figure 8 A schematic diagram of the local structure of the lesion in a patient with aortic dissection;

[0031] Figure 9 This is a schematic diagram showing the positioning of an aortic stent graft system for reconstructing supra-aortic branches within the aorta in some embodiments of the present invention.

[0032] Figure 10 This is a schematic diagram illustrating the release of an aortic stent graft system for reconstructing supra-aortic branches within the aorta, according to some embodiments of the present invention.

[0033] Figure 11 A schematic diagram of the positioning of a short-branch stent in the aorta of an aortic stent graft system for reconstructing supra-aortic branches in some embodiments of the present invention.

[0034] Figure 12 This is a schematic diagram of the release of a short-branch stent in the aorta of an aortic stent graft system for reconstructing supra-aortic branches in some embodiments of the present invention.

[0035] Figure 13 This is a schematic diagram illustrating the release of a single-branch stent in the aorta using an aortic stent graft system for reconstructing branches of the aortic arch in some embodiments of the present invention.

[0036] In the diagram: 100 - Aortic stent graft system for reconstructing supra-aortic branches; 101 - Main stent; 102 - Branch stent; 103 - Mesh window structure; 104 - First medial identification structure; 105 - First lateral identification structure; 106 - Second medial identification structure; 107 - Second lateral identification structure; 108 - First proximal identification structure; 109 - Second proximal identification structure; 110 - Third proximal identification structure; 111 - Fourth proximal identification structure; 112 - First distal identification structure; 113 - Second distal identification structure; 114 - Mesh wire; 115 - Knot; 116 - First edge identification structure; 117 - Second edge identification structure; 118 - Third edge identification structure; 119 - Fourth edge identification structure; 12 0 - Position recognition structure; 121 - Window structure; 122 - Short support; 123 - Short support body; 124 - Short support brim structure; 125 - First starting recognition structure; 126 - Second starting recognition structure; 127 - Third starting recognition structure; 128 - Fourth starting recognition structure; 129 - First short support proximal recognition structure; 130 - Second short support proximal recognition structure; 131 - Third short support proximal recognition structure; 132 - Fourth short support proximal recognition structure; 133 - First short support distal recognition structure; 134 - Second short support distal recognition structure; 135 - First brim recognition structure; 136 - Second brim recognition structure; 137 - Third brim recognition structure; 138 - Fourth brim recognition structure;

[0037] 601 - Ultra-hard guidewire; 602 - Branched traction guidewire; 603 - First support delivery system;

[0038] 801 - Branch segment of a single-branch stent; 802 - Main body of a single-branch stent; 803 - Partial coverage segment;

[0039] 11-Aortic arch; 12-Ascending aorta; 13-Descending aorta; 14-Bracocephalic trunk; 15-Left common carotid artery; 16-Left subclavian artery. Detailed Implementation

[0040] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] The purpose of this invention is to provide an aortic stent graft system and device for reconstructing the supra-aortic branches, which can realize the reconstruction of the brachiocephalic trunk and the left common carotid artery.

[0042] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0043] Example 1

[0044] like Figures 1 to 13As shown, this embodiment provides an aortic stent graft system 100 for reconstructing the supra-aortic branches. The left common carotid artery 15 is located between the brachiocephalic trunk 14 and the left subclavian artery 16. For patients with aortic dissection or aneurysm lesions involving the brachiocephalic trunk 14 and the left common carotid artery 15, this embodiment's aortic stent graft system 100 for reconstructing the supra-aortic branches, combined with an integrated single-branch stent, simultaneously operates on the brachiocephalic trunk 14, the left common carotid artery 15, and the left subclavian artery 16, achieving reconstruction of the three branches of the supra-aortic arch. The aortic stent graft system 100 for reconstructing the supra-aortic branches in this embodiment includes: a main stent 101, a branch stent 102, a window structure 121, a short branch stent 122, and a mesh window structure 103. The main stent 101, branch stent 102, window structure 121, and mesh window structure 103 form an integrated structure. The branch stent 102, window structure 121, and mesh window structure 103 are arranged sequentially along the axial direction of the main stent 101. The main stent 101 is a hollow covered stent structure used to treat the lesion of the aortic disease. The branch stent 102 is positioned proximally to the main stent 101 and can be used to reconstruct the brachiocephalic trunk 14. One end of the branch stent 102 is connected to the sidewall of the main stent 101, and the connection point is located on the greater curvature side of the main stent 101. The mesh window structure 103 is positioned distally to the main stent 101 and is located on the sidewall of the main stent 101 on the greater curvature side. The mesh window structure 103 corresponds to the position of the left subclavian artery 16 and has reserved space for the left subclavian artery 16. The subclavian artery 16 has a processing space for subsequent reconstruction of the left subclavian artery 16. The main stent 101 has a window structure 121 on its side wall. The window structure 121 is located between the branch stent 102 and the mesh window structure 103, that is, the distal end of the branch stent 102 on the greater curvature side of the main stent 101. The window structure 121 reserves space for the reconstruction of the left common carotid artery 15. The window structure 121 is used to set the short branch stent 122. The short branch stent 122 is an independent structure from the main stent 101. The short branch stent 122 is used for the reconstruction of the left common carotid artery 15. This invention provides a safe, reliable, and easy-to-operate endovascular repair device. The main stent 101 has a branch stent 102, a window structure 121, and a mesh window structure 103 arranged sequentially on the large curved side. It can repair the lesion site through the femoral artery approach, and move the proximal anchoring area forward to the brachiocephalic trunk 14. When used in conjunction with a single branch stent, it can operate on the brachiocephalic trunk 14, the left common carotid artery 15, and the left subclavian artery 16 to achieve endovascular reconstruction that fully conforms to the physiological anatomical structure and follows the blood flow direction.

[0045] In some specific designs, the main support 101 is cylindrical, hollow inside, and has openings at both the proximal and distal ends.

[0046] In some specific designs, the main support 101 includes a support body and a membrane, with the membrane applied to the outer surface of the support body. The support body is made of nickel-titanium alloy, and the membrane is made of a permeable polyester membrane.

[0047] In some specific designs, the proximal end of the main support 101 is provided with a first inner identification structure 104 and a first outer identification structure 105, and the distal end of the main support 101 is provided with a second inner identification structure 106 and a second outer identification structure 107. Both the first inner identification structure 104 and the second inner identification structure 106 are used to identify the inner side of the main support 101, and both the first outer identification structure 105 and the second outer identification structure 107 are used to identify the outer side of the main support 101. The first inner identification structure 104, the first outer identification structure 105, the second inner identification structure 106, and the second outer identification structure 107 are all made of metal. The first inner identification structure 104, the first outer identification structure 105, the second inner identification structure 106, and the second outer identification structure 107 can be configured with different shapes, or the first inner identification structure 104 and the second inner identification structure 106 can be configured with the same shape, and the first outer identification structure 105 and the second outer identification structure 107 can be configured with the same shape. For example, the first inner identification structure 104 and the second inner identification structure 106 can be rectangles, and the first outer identification structure 105 and the second outer identification structure 107 can be figure-eight shapes.

[0048] In some specific designs, two position identification structures 120 are also provided at the proximal end of the main support 101. The two position identification structures 120 are arranged opposite each other, and each position identification structure 120 is located between the first inner identification structure 104 and the first outer identification structure 105. That is, the first inner identification structure 104, one position identification structure 120, the first outer identification structure 105, and the other position identification structure 120 are evenly arranged circumferentially at the proximal end of the main support 101. In addition to marking, the first inner identification structure 104, one position identification structure 120, the first outer identification structure 105, and the other position identification structure 120 can achieve better intraoperative positioning and better observation of phenomena such as inversion and torsion.

[0049] In some specific designs, the branch support 102 is cylindrical and hollow inside. Both ends of the branch support 102 have openings. The connection between one end of the branch support 102 and the side wall of the main support 101 is a high-precision stitch. When not under pressure, the branch support 102 and the main support 101 are vertically aligned. Under pressure, the end of the branch support 102 connected to the main support 101 is fixed, while the position of the free end of the branch support 102 can change. When not under stress, the angle between the branch support 102 and the main support 101 is 90°. Under stress, the free end of the branch support 102 can have a lateral range of motion of 150° in all directions.

[0050] In some specific designs, the branch stent 102 is provided with a first proximal identification structure 108, a second proximal identification structure 109, a third proximal identification structure 110, a fourth proximal identification structure 111, a first distal identification structure 112, and a second distal identification structure 113. The first proximal identification structure 108 is used to identify the side of the proximal end of the branch stent 102 that is close to the proximal end of the aorta. The second proximal identification structure 109 is used to identify the side of the proximal end of the branch stent 102 that is close to the distal end of the aorta. The third proximal identification structure 110 and the fourth proximal identification structure 111 are used to identify the proximal end of the branch stent 102. The first proximal identification structure 108, the second proximal identification structure 109, the third proximal identification structure 110, and the fourth proximal identification structure 111 are used in endovascular aortic repair surgery for precise alignment and angular and directional identification of the proximal end of the branch stent 102 and the opening of the left common carotid artery. The first distal identification structure 112 is used to identify the side of the distal end of the branch stent 102 closest to the proximal end of the aorta, and the second distal identification structure 113 is used to identify the side of the distal end of the branch stent 102 closest to the distal end of the aorta. The first proximal identification structure 108, the second proximal identification structure 109, the third proximal identification structure 110, the fourth proximal identification structure 111, the first distal identification structure 112, and the second distal identification structure 113 are all made of metallic materials. The first proximal recognition structure 108, the second proximal recognition structure 109, the third proximal recognition structure 110, the fourth proximal recognition structure 111, the first distal recognition structure 112, and the second distal recognition structure can be configured with different shapes. Alternatively, the first proximal recognition structure 108 and the second proximal recognition structure 109 can be configured with the same shape, the third proximal recognition structure 110 and the fourth proximal recognition structure 111 can be configured with the same shape, and the first distal recognition structure 112 and the second distal recognition structure 113 can be configured with the same shape. For example, the first proximal recognition structure 108, the second proximal recognition structure 109, the third proximal recognition structure 110, the fourth proximal recognition structure 111, the first distal recognition structure 112, and the second distal recognition structure 113 can all be of the "O" shape.

[0051] In some specific designs, the window structure 121 is configured in several specific models, each with different placement and dimensions. These models are designed based on the geometric morphology of the aortic structure in the patient population. By using different models of the window structure 121, the needs of 80% of patients can be covered. The size of the window structure 121 is slightly smaller than the size of the origin of the left common carotid artery projected onto the aorta. The short stent 122 has a top-hat structure, comprising a short stent body 123 and a short stent cap structure 124. The short stent body 123 is hollow internally, with openings at both ends. The short stent cap structure 124 is located at one end of the short stent body 123 and is annular in shape. The inner side of the short support body 123 is connected to one end of the short support body 123. The other end of the short support body 123 can pass through the window structure 121. The inner edge dimension of the short support cap structure 124 is slightly larger than the dimension of the window structure 121. The cap structure is adjacent to the window structure 121. The short support cap structure 124 cooperates with the window structure 121 to limit the position of the short support body 123. The short support cap structure 124 is used to increase the support, fixation and sealing of the short support 122, and reduce the risk of branch restenosis, support displacement and internal leakage. When the short support 122 is set at the window structure 121, the edge of the short support cap structure 124 near the proximal end is located between the branch support 102 and the window structure 121, and overlaps with the main support 101 between the branch support 102 and the window structure 121; the edge of the short support cap structure 124 near the distal end is located between the window structure 121 and the mesh window structure 103, and overlaps with the main support 101 between the window structure 121 and the mesh window structure 103.

[0052] In some specific designs, the window structure 121 is provided with a first starting recognition structure 125, a second starting recognition structure 126, a third starting recognition structure 127, and a fourth starting recognition structure 128. The first starting recognition structure 125 is used to recognize the proximal end of the window, the second starting recognition structure 126 is used to recognize the distal end of the window, and the third and fourth starting recognition structures 127 and 128 are arranged opposite to each other and are used to recognize the horizontal boundary of the window. The first starting recognition structure 125, the second starting recognition structure 126, the third starting recognition structure 127, and the fourth starting recognition structure 128 are all made of metal. The first starting recognition structure 125, the second starting recognition structure 126, the third starting recognition structure 127, and the fourth starting recognition structure 128 can be set to the same shape or different shapes.

[0053] In some specific designs, the short stent body 123 is provided with a first short stent proximal identification structure 129, a second short stent proximal identification structure 130, a third short stent proximal identification structure 131, a fourth short stent proximal identification structure 132, a first short stent distal identification structure 133, and a second short stent distal identification structure 134. The first short stent proximal identification structure 129 is used to identify the side of the short stent 122 proximal to the proximal end of the aorta; the second short stent proximal identification structure 130 is used to identify the side of the short stent 122 proximal to the distal end of the aorta; the third short stent proximal identification structure 131 and the fourth short stent proximal identification structure 132 are used to identify the proximal end of the short stent 122; and the first short stent distal identification structure 133 is used to identify the side of the short stent 122 distal to the aorta. On the side proximal to the aorta, the distal end identification structure 134 of the second short stent is used to identify the side of the distal end of the short stent 122 that is close to the distal end of the aorta. The proximal end identification structures 129, 130, 131, 132, 133, and 134 of the first and second short stents are all made of metal. The proximal end identification structures 129, 130, 131, 132, 133, and 134 of the first and second short stents can be made of the same shape or different shapes.

[0054] In some specific designs, the outer side of the short stent cap structure 124 is provided with a first cap structure 135, a second cap structure 136, a third cap structure 137, and a fourth cap structure 138. The first cap structure 135 is used to identify the side of the cap structure near the proximal end of the aorta, the second cap structure 136 is used to identify the side of the cap structure near the distal end of the aorta, and the third cap structure 137 and the fourth cap structure 138 are used to identify the edge of the short stent cap structure 124. The first cap structure 135, the second cap structure 136, the third cap structure 137, and the fourth cap structure 138 are all made of metal. The first cap structure 135, the second cap structure 136, the third cap structure 137, and the fourth cap structure 138 can be set to the same shape or to different shapes.

[0055] In some specific designs, the mesh window structure 103 is located at the distal end of the window structure 121 on the large bend side of the main support. The mesh window structure 103 is elliptical in shape, and its shape matches the projection of the origin of the left subclavian artery 16 onto the aorta. The size (area) of the mesh window structure 103 is larger than the size (area) of the projection of the origin of the left subclavian artery 16 onto the aorta.

[0056] In some specific designs, the edge of the mesh window structure 103 is connected to the main support 101 by high-precision suturing. The mesh window structure 103 is woven from mesh wire 114, preferably fine metal wire. The mesh wire 114 is woven to form several quadrilateral holes. The mesh wire 114 is made of nickel-titanium alloy. Knots 115 are provided on the mesh wire 114 to connect with the mesh wire 114. The knots 115 are preferably sliding fisherman's knots. The knots 115 are set at the connection of adjacent holes. The sliding knots 115 allow the holes to be enlarged or reduced within a certain range, which is beneficial for subsequent interventional operations when reconstructing the left subclavian artery 16.

[0057] In some specific designs, the edges of the mesh window structure 103 are provided with a first edge recognition structure 116, a second edge recognition structure 117, a third edge recognition structure 118, and a fourth edge recognition structure 119. The first edge recognition structure 116 is used to identify the proximal end of the mesh window structure 103, the second edge recognition structure 117 is used to identify the distal end of the mesh window structure 103, and the third edge recognition structure 118 and the fourth edge recognition structure 119 are arranged opposite to each other. The first edge recognition structure 116 and the second edge recognition structure 117 are located at the two ends of the major axis of the ellipse, and the third edge recognition structure 118 and the fourth edge recognition structure 119 are located at the two ends of the minor axis of the ellipse. The third edge recognition structure 118 and the fourth edge recognition structure 119 are used to identify the lateral boundary of the mesh window structure 103. The first edge recognition structure 116, the second edge recognition structure 117, the third edge recognition structure 118, and the fourth edge recognition structure 119 can identify the position and orientation when the mesh window structure 103 is sewn to the support body. The first edge recognition structure 116, the second edge recognition structure 117, the third edge recognition structure 118, and the fourth edge recognition structure 119 are all made of metal. The first edge recognition structure 116, the second edge recognition structure 117, the third edge recognition structure 118, and the fourth edge recognition structure 119 are shaped like an "O". These structures can also be used to locate the edges of the mesh-like window structure 103 during intraoperative angiography, when subsequently reconstructing the left subclavian artery 16 using a single-branch stent (e.g.) Figure 13As shown), the first edge recognition structure 116 at the proximal end of the mesh window structure 103 should be covered by the proximal end covered stent of the single-branch stent, that is, the part of the covered segment 803 of the main body 802 of the single-branch stent overlaps with the main stent 101, which can realize the physiological reconstruction of the brachiocephalic trunk 14, the left common carotid artery 15 and the left subclavian artery 16 above the aortic arch 11.

[0058] The mesh window structure 103 of this embodiment reserves processing space for the left subclavian artery 16, which can be used to increase the radial support force applied to the outer lumen of the main stent 101, and has a certain supporting effect on the local blood vessel wall, ensuring the integrity of the stent and reducing the risk of distal stent displacement caused by the blood flow "storm effect" during stent deployment.

[0059] The aortic stent graft system 100 for reconstructing the upper branches of the aortic arch in this embodiment is suitable for the anatomical structure of the aortic arch 11. Its implantation in the aortic arch 11 can be used to close the primary rupture and reconstruct the left common carotid artery 15. The aortic stent graft system 100 for reconstructing the upper branches of the aortic arch in this embodiment can be combined with an integrated single-branch stent implanted in the aorta to simultaneously treat the brachiocephalic trunk 14, the left common carotid artery 15 and the left subclavian artery 16, thereby achieving the reconstruction of the three branches of the aortic arch 11. When used in conjunction with a single-branch stent, the aortic stent graft system 100 for reconstructing the superior branch of the aortic arch is deployed first, followed by the deployment of the single-branch stent. From a three-dimensional perspective, the deployment of the aortic stent graft system 100 for reconstructing the superior branch of the aortic arch and the single-branch stent is nested. From a two-dimensional perspective, the docking method between the aortic stent graft system 100 for reconstructing the superior branch of the aortic arch and the single-branch stent is partial coverage. The proximal end of the single-branch stent is located on the main stent 101 between the window structure 121 and the mesh window structure 103, that is, the proximal end of the single-branch stent overlaps with the main stent 101 between the window structure 121 and the mesh window structure 103.

[0060] The aortic stent graft system 100 for reconstructing supra-aortic branches in this embodiment allows the proximal anchoring zone of the stent to be moved anteriorly to the brachiocephalic trunk 14, broadening the indications for endovascular treatment of the aortic arch. The integrated structure of the main stent 101 and the branch stent 102 increases the anchoring force of the stent, avoiding stent displacement caused by the "storm effect" of aortic blood flow. The short branch stent 122 enhances the radial expansion force in the left common carotid artery 15, avoiding stenosis or occlusion of branch vessels. In this embodiment, the main stent 101 is a complete hollow structure, and the branch stent 102 is externally positioned, which will not cause iatrogenic occlusion of the aortic arch 11 lumen or changes in hemodynamics. The aortic dissection or aneurysm involving the brachiocephalic trunk 14 is repaired endovascularly using a total femoral artery approach. For the reconstruction of the supra-aortic three branches, no carotid artery puncture, incision, or bypass surgery is required. It can be used in conjunction with existing integrated single-branch stents to reconstruct the supra-aortic three branches, namely the brachiocephalic trunk 14 and the left common carotid artery. Artery 15 and the left subclavian artery 16 are reconstructed, ensuring that all reconstructed branches fully conform to the anatomical and physiological structure and hemodynamic pattern. The window structure 121 on the greater curvature side of the main stent 101 can be personalized to match the existing stent according to the patient's anatomical characteristics, reducing the complexity of intraoperative procedures and the risk of neurological complications compared with in situ fenestration. Compared with pre-fenestration, it increases the accuracy of window alignment and ensures the integrity of the stent. The short branch stent cap structure 124 of the short branch stent 122 is adjacent to the window structure 121, increasing the support, fixation and sealing of the short branch stent 122, reducing the risk of branch stenosis, stent displacement and endoleak. The mesh window structure 103 reserved on the greater curvature side of the main stent 101 is made of nickel-titanium alloy wire and is fixed by a sliding knot 115. The window size of the mesh window structure 103 can be freely adjusted to facilitate subsequent reconstruction of the left subclavian artery 16, while reducing the risk of postoperative stenosis or occlusion of the left subclavian artery 16.

[0061] Example 2

[0062] like Figures 1 to 8As shown, this embodiment provides an aortic stent graft device for reconstructing the supra-aortic branch, including a first stent delivery system 603 and an aortic stent graft system 100 for reconstructing the supra-aortic branch according to Embodiment 1. The first stent delivery system 603 is used to deliver and release the aortic stent graft system 100 for reconstructing the supra-aortic branch to a predetermined location. The aortic stent graft system 100 for reconstructing the supra-aortic branch can be used in conjunction with a single-branch stent. The first stent delivery system 603 closes the primary rupture and reconstructs the brachiocephalic trunk 14, the left common carotid artery 15, and the left subclavian artery 16 via a full femoral artery approach. When deploying the stent, the aortic stent graft system 100 for reconstructing the supra-aortic branch is deployed first, followed by the single-branch stent. From a three-dimensional perspective, the deployment method between the aortic stent graft system 100 for reconstructing the supra-aortic branch and the single-branch stent is nested; from a two-dimensional perspective, the docking method between the aortic stent graft system 100 for reconstructing the supra-aortic branch and the single-branch stent is partial coverage.

[0063] The usage process of this embodiment:

[0064] For patients with aortic dissection or aneurysm involving the brachiocephalic trunk 14, the Aortic Stent Graft System 100 for reconstructing the supra-aortic branches, combined with an integrated single-branch stent for reconstructing the supra-aortic three branches, was used. The bilateral brachial and femoral arteries were punctured using the Seldinger technique, and catheter sheaths were inserted. Two Proglide linear staplers were pre-embedded in one femoral artery for later use. A pigtail catheter was inserted through the other femoral artery into the ascending aorta 12 for angiography and pressure measurement for later use. A gold-marked pigtail catheter was inserted through one femoral artery approach, ascending via segmental angiography into the ascending aorta 12, marking the supra-aortic branch sites. The Landerquist ultra-rigid guidewire 601 was replaced. A 5F single-curved catheter was placed in the brachiocephalic trunk 14 via the femoral artery. The traction guidewire of the branch segment was advanced along the 5F single-curved catheter to the brachiocephalic trunk 14 and pulled out through the right brachial artery, then the 5F single-curved catheter was withdrawn. The aortic stent graft system 100 for reconstructing the supra-aortic branches is advanced to the predetermined site on the aortic arch 11, and the window structure 121 is aligned with the opening of the left common carotid artery (e.g., Figure 9 The branch segment was pulled into the left common carotid artery 15 by pulling the branch traction guide wire 602, and then intraoperative angiography was performed to determine the location of the aortic stent graft system 100 used to reconstruct the supra-aortic branch. Finally, the main stent 101 and the branch stent 102 were completely released (e.g., Figure 10The pigtail catheter was used to deliver the stent to the ascending aorta segment 12. Re-angiography confirmed stent placement and good morphology, with unobstructed blood flow in the branches of the brachiocephalic trunk 14 and no significant endoleak. Subsequently, a short-branch stent 122 was delivered to the left common carotid artery 15 via the femoral artery. The identification structures at the initiation of the stent (proximal identification structures 129, 130, 131, and 132) overlapped with the edge identification structures of the window structure 121 (first initiation identification structure 125, 126, 127, and 128). The short-branch stent 122 was then released to reconstruct the left common carotid artery, embedding it within the window structure 121 and ensuring its cap structure 124 was tightly abutted against the inner wall of the main stent. Re-angiography using the pigtail catheter confirmed stent placement and good morphology, with unobstructed blood flow in the branches of the left common carotid artery and no significant endoleak.

[0065] After confirming that the aortic stent graft system 100 for reconstructing the supra-aortic branches is well-positioned, the first stent delivery system 603 is withdrawn. Then, the second stent delivery system with a single-branch stent is introduced into the descending aorta 13 along the ultra-rigid guidewire 601 and pushed to the predetermined site in the aorta. The branch segment 801 of the single-branch stent is introduced into the left subclavian artery 16 through the mesh window structure 103. The single-branch stent is released, so that the proximal end of the single-branch stent partially overlaps with the aortic stent graft system 100 for reconstructing the supra-aortic branches. Finally, the reconstruction of the three supra-aortic branches of aortic dissection or aneurysm—the brachiocephalic trunk 14, the left common carotid artery 15, and the left subclavian artery 16—is achieved via a total femoral artery approach using the aortic stent graft system 100 and the integrated single-branch stent for reconstructing the supra-aortic branches.

[0066] In this embodiment, the terms "proximal end" and "distal end" refer to the relative position and direction of the components relative to each other when viewed from the perspective of the heart after the main stent is implanted in the human body. Generally, the proximal end refers to the end closer to the heart, and the distal end refers to the end farther away from the heart.

[0067] In the description of this invention, it should be understood that the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0068] In the description of this invention, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0069] In addition, unless otherwise stated, the terms used in any of the technical solutions disclosed in this invention to indicate positional relationships or shapes include states or shapes that are similar to, close to, or approximate with those states or shapes.

[0070] Any component provided by this invention can be assembled from multiple individual components or can be a single component manufactured by a one-piece molding process.

[0071] It should be noted that the structures, proportions, sizes, etc., depicted in the accompanying drawings of this specification are only used to complement the content disclosed in the specification, so as to enable those skilled in the art to understand and read them, and are not intended to limit the conditions under which the present invention can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportions, or adjustments to the size, without affecting the effects and objectives that the present invention can produce, should still fall within the scope of the technical content disclosed in the present invention.

[0072] It should also be noted that in the embodiments of this application, the same reference numerals are used to denote the same component or the same part.

[0073] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0074] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. An aortic stent graft system for reconstructing supra-aortic branches, characterized in that: include: The system comprises a main stent, branch stents, a window structure, short branch stents, and a mesh-like vent structure. The main stent is a hollow, covered stent structure used to treat lesions in the aorta. The branch stents are positioned proximally to the main stent, with one end connected to the sidewall of the main stent, for reconstruction of the brachiocephalic trunk. The mesh-like vent structure is located distally to the sidewall of the main stent near the initiation of the branch stent, corresponding to the left subclavian artery, for subsequent reconstruction of the left subclavian artery. The window structure is located between the branch stents and the mesh-like vent structure, and is used to house the short branch stents for reconstruction of the left common carotid artery.

2. The aortic stent graft system for reconstructing supra-aortic branches according to claim 1, characterized in that: The main support is hollow inside, and both the proximal and distal ends of the main support are provided with openings; the main support includes a support body and a covering film, and the covering film is provided on the outer surface of the support body.

3. The aortic stent graft system for reconstructing supra-aortic branches according to claim 1, characterized in that: The main support has a first inner identification structure and a first outer identification structure at its proximal end, and a second inner identification structure and a second outer identification structure at its distal end. The first inner identification structure and the second inner identification structure are both used to identify the inner side of the main support, and the first outer identification structure and the second outer identification structure are both used to identify the outer side of the main support. The main support is further provided with two position recognition structures at its proximal end for identifying whether the main support is twisted or rotated. The two position recognition structures are arranged opposite to each other, and each position recognition structure is located between the first inner recognition structure and the first outer recognition structure.

4. The aortic stent graft system for reconstructing supra-aortic branches according to claim 1, characterized in that: The branch bracket is hollow inside, and both one end and the other end of the branch bracket are provided with openings. One end of the branch bracket is sewn to the side wall of the main bracket.

5. The aortic stent graft system for reconstructing supra-aortic branches according to claim 1, characterized in that: The branch stent is provided with a first proximal identification structure, a second proximal identification structure, a third proximal identification structure, a fourth proximal identification structure, a first distal identification structure, and a second distal identification structure. The first proximal identification structure is used to identify the side of the proximal end of the branch stent that is close to the proximal end of the aorta. The second proximal identification structure is used to identify the side of the proximal end of the branch stent that is close to the distal end of the aorta. The third and fourth proximal identification structures are used to identify the proximal end of the branch stent. The first distal identification structure is used to identify the side of the distal end of the branch stent that is close to the proximal end of the aorta. The second distal identification structure is used to identify the side of the distal end of the branch stent that is close to the distal end of the aorta.

6. The aortic stent graft system for reconstructing supra-aortic branches according to claim 1, characterized in that: The size of the window structure is smaller than the size of the origin of the left common carotid artery projecting onto the aorta; the short stent includes a short stent body and a short stent cap structure. The short stent body is hollow inside, and both one end and the other end of the short stent body have openings. The short stent cap structure is located at one end of the short stent body, and the inner side of the short stent cap structure is connected to one end of the short stent body. The other end of the short stent body can pass through the window structure. The size of the short stent cap structure is larger than the size of the window structure. The short stent cap structure cooperates with the window structure to restrict the position of the short stent body.

7. The aortic stent graft system for reconstructing supra-aortic branches according to claim 6, characterized in that: The window structure is provided with a first starting recognition structure, a second starting recognition structure, a third starting recognition structure and a fourth starting recognition structure. The first starting recognition structure is used to recognize the proximal end of the window, the second starting recognition structure is used to recognize the distal end of the window, and the third starting recognition structure and the fourth starting recognition structure are arranged opposite to each other and are used to recognize the horizontal boundary of the window. The short stent body is provided with a first short stent proximal identification structure, a second short stent proximal identification structure, a third short stent proximal identification structure, a fourth short stent proximal identification structure, a first short stent distal identification structure, and a second short stent distal identification structure. The first short stent proximal identification structure is used to identify the side of the short stent proximal end that is close to the proximal end of the aorta. The second short stent proximal identification structure is used to identify the side of the short stent proximal end that is close to the distal end of the aorta. The third and fourth short stent proximal identification structures are used to identify the proximal end of the short stent. The first short stent distal identification structure is used to identify the side of the short stent distal end that is close to the proximal end of the aorta. The second short stent distal identification structure is used to identify the side of the short stent distal end that is close to the distal end of the aorta. The short stent cap brim structure is provided with a first cap brim recognition structure, a second cap brim recognition structure, a third cap brim recognition structure and a fourth cap brim recognition structure on its outer side. The first cap brim recognition structure is used to identify the side of the cap brim that is close to the proximal end of the aorta. The second cap brim recognition structure is used to identify the side of the cap brim that is close to the distal end of the aorta. The third cap brim recognition structure and the fourth cap brim recognition structure are used to identify the edge of the short stent cap brim structure.

8. The aortic stent graft system for reconstructing supra-aortic branches according to claim 1, characterized in that: The size of the mesh window structure is larger than the size of the origin of the left subclavian artery projected onto the aorta; the mesh window structure is made of woven mesh wires, and the mesh wires are provided with knots that are slidably connected to the mesh wires.

9. The aortic stent graft system for reconstructing supra-aortic branches according to claim 1, characterized in that: The edges of the mesh window structure are provided with a first edge recognition structure, a second edge recognition structure, a third edge recognition structure and a fourth edge recognition structure. The first edge recognition structure is used to identify the proximal end of the mesh window structure, the second edge recognition structure is used to identify the distal end of the mesh window structure, and the third edge recognition structure and the fourth edge recognition structure are arranged opposite to each other to identify the lateral boundary of the mesh window structure.

10. An aortic stent graft device for reconstructing supra-aortic branches, characterized in that: Includes a first stent delivery system and the aortic stent graft system for reconstructing the supra-aortic branch as described in any one of claims 1-9, wherein the first stent delivery system is used to deliver and release the aortic stent graft system for reconstructing the supra-aortic branch to a predetermined location.

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