Aortic Stent Graft

Abstract

The present invention provides an aortic covered stent, which relates to the field of medical devices, including a main stent and an embedded stent; the main region of the main stent is covered on the side surface to open at least one embedded branch opening, and the embedded branch opening and the corresponding connected embedded stent meet the following requirements: the embedded stent includes a straight section and a curved section that are mutually connected in the axial direction, and the straight section and the curved section are both covered stents, and the circumferences of the two are sealed and connected, and the inner cavities are interconnected; the straight section is parallel and fixedly connected to the main stent, and there is a gap between the outer circumference of the straight section and any branch opening area of ​​the main stent; the curved section is bent toward the embedded branch opening, and the edge of the second embedded opening is connected to the edge of the embedded branch opening. Compared with the prior art, the aortic covered stent provided by the present invention reduces the difficulty of superselection of the branch guidewire, and also has the beneficial effects of avoiding the "bird's beak effect", reducing the probability of reverse tearing dissection and type I internal leakage, etc.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an aortic stent graft. Background Art

[0002] In the prior art, when a patient's aortic dissection or thoracic aortic aneurysm involves the aortic arch, the optional surgical methods include open surgery and supra-arch branch interventional surgery. Open surgery uses artificial blood vessels or a hybrid surgery of artificial blood vessels + covered stents to replace the patient's diseased blood vessels. Supra-arch branch interventional surgery is to implant covered stents in the aortic arch, descending aorta, and three branches above the aortic arch through interventional methods, thereby isolating the blood flow in the lesion site and establishing a new blood flow channel.

[0003] The defects of the prior art are as follows:

[0004] For open surgery, the patient's chest needs to be opened, which is very traumatic. In addition, extracorporeal circulation needs to be established during the operation. Deep hypothermic cerebral perfusion, circulatory arrest and other operations can cause great damage to the patient's brain and may even lead to brain death.

[0005] Although supra-arcuate branch interventional surgery can effectively reduce the risk of trauma and stroke in patients, the existing supra-arcuate branch interventional surgery still has great shortcomings:

[0006] ① Difficulty in inserting the branch guidewire. In order to ensure smooth blood flow in the left common carotid branch, the existing technology products mostly orient the left common carotid branch stent toward the proximal aorta (antegrade blood flow). Therefore, the direction of the embedded opening of the left common carotid branch of the main stent is set to be parallel to the axial direction of the main stent (the embedded proximal opening and distal opening both extend along the axial direction of the main stent). The guidewire is always perpendicular to the aortic arch during the process of entering the aorta from the left common carotid artery. In the process of inserting the guidewire into the embedded opening, the conveyor needs to add a step of bending the guidewire head end, otherwise the guidewire will not be able to be inserted into the embedded opening of the left common carotid branch of the main stent.

[0007] ② The operating space for branch guidewire selection is small. To prevent the occurrence of type I endoleak, the main stent needs to fit closely with the vascular wall of the aortic arch, which causes the guidewire and catheter to directly contact the main stent when passing through the opening of the left common carotid artery, leaving no space for angle adjustment, making it difficult to select the embedded opening.

[0008] ③ Affects the hemodynamics of the aortic arch. In order to expand the space for the left common carotid artery guidewire to be embedded, some existing products design the corresponding part of the arch of the main stent into a concave structure with a very large axial span. The defect of this structure is that it reduces the diameter of the lumen of the main stent in the aortic arch, affecting the hemodynamics of the aorta in this part. In addition, this concave design with a very large axial span causes the main stent to be unable to fit the wall of the top of the aortic arch, and there is a risk of type I endoleak.

[0009] ④ The "bird's beak effect" of the thoracic aortic stent graft. Since the aortic stent graft is straight in its natural state, when the stent graft is implanted into the aorta, the stent graft will be bent and will generate a straightening force, but it will be constrained by the aortic lumen and cannot be straightened, resulting in the stent graft generating a large force on the greater curvature of the aorta and a "bird's beak effect" on the lesser curvature (the blood vessel has a large bending angle, the stent graft is poorly attached to the blood vessel wall, and an angle is formed between the blood vessel and the proximal end of the stent graft, causing endoleak, which resembles a "bird's beak" in shape). Therefore, after the stent graft is implanted, the wall of the greater curvature side is continuously stimulated by the stent graft and is prone to reverse tearing and dissection, and the "bird's beak effect" on the lesser curvature side leads to type I endoleak.

[0010] ⑤ Reverse tear dissection of the ascending aorta. The proximal stent of the aortic covered stent in the prior art adopts a Z-shaped wire-wound stent. In order to ensure that type I endoleak does not occur in the proximal anchoring area of ​​the aorta, the proximal stent must meet two characteristics: one is sufficient support force, and the other is good wall adhesion. Therefore, the proximal stents in the prior art all adopt multi-peak Z-shaped stents to establish a balance between the two (the more peaks, the better the wall adhesion, but the support force decreases; the fewer peaks, the higher the support force, but the wall adhesion is poor). When aortic dissection or aneurysm involves the aortic arch, the vascular endothelium of the ascending aorta is often accompanied by symptoms such as edema. At this time, the intima of the ascending aorta is relatively fragile. In addition, the pulsation of the ascending aorta is larger than that of the arterial wall in other positions. Under the continuous stimulation of the tip of the Z-shaped stent, the intima is easily ruptured, resulting in reverse tear dissection. Summary of the invention

[0011] The purpose of the present application is to provide an aortic covered stent to alleviate the technical problems existing in the prior art.

[0012] To achieve the above objectives, this application adopts the following technical solutions:

[0013] The present application provides an aortic covered stent, comprising a main stent and an embedded stent, wherein the embedded stent is a covered stent;

[0014] The main body bracket at least includes a main body area with a coating connected to the circumference, and the side coating of the main body area is provided with at least one branch opening, wherein at least one of the branch openings is internally connected to the embedded bracket to form an embedded branch opening, and the embedded branch opening and the corresponding embedded bracket meet the following conditions:

[0015] The embedded bracket includes a straight section and a curved section that are axially interconnected, and both the straight section and the curved section are coated brackets, the circumferential surfaces of the two are sealed and connected, and the inner cavities are interconnected; the end surface of the straight section away from one end of the curved section forms a first embedded opening, and the end surface of the curved section away from one end of the straight section forms a second embedded opening; the straight section is parallel to and fixedly connected to the main bracket, and there is a gap between the outer circumferential surface of the straight section and any branch opening area of ​​the main bracket; the curved section is bent toward the embedded branch opening, and the edge of the second embedded opening is connected to the edge of the embedded branch opening.

[0016] In the technical solution of the present application, optionally, in the embedded bracket, the curved section includes an elbow section and an eccentric frustum section whose circumferential surfaces are sealed and whose inner cavities are interconnected;

[0017] One end of the elbow section away from the eccentric frustum section is connected to one end of the straight tube section away from the first embedded opening, the diameter of the eccentric frustum section gradually increases from the end connected to the elbow section toward the end away from the elbow section, and the elliptical end surface of the eccentric frustum section away from the elbow section forms the second embedded opening.

[0018] In the technical solution of the present application, optionally, in the main body support, the area where the embedded branch opening is located is recessed toward the inner cavity of the main body support relative to other parts of the circumference of the main body support.

[0019] In the technical solution of the present application, optionally, the aortic covered stent also includes a pre-bent tube that is pre-bent into an arc shape and has elasticity; the pre-bent tube is fixedly connected to the main stent along the axial direction of the main stent, and the pre-bent tube can rebound when the main stent is freely released, so as to bend the main stent into a bent shape in which the branch opening is located on the large curve side and the opposite side of the branch opening is located on the small curve side.

[0020] In the technical solution of the present application, optionally, the proximal region of the main support is a corolla-type end support; the corolla-type end support includes a plurality of proximal arc units and a plurality of distal arc units, wherein a single proximal arc unit and a single distal arc unit are opposite in the axial opening direction and are arranged staggered with each other in the circumferential direction and connected end to end; the bending radius of the proximal arc unit is greater than the bending radius of the distal arc unit, and the arc region of the proximal arc unit is radially bent toward the internal region of the skeleton in an inward-curling shape.

[0021] In this optional scheme, further optionally, in the main support, the hollow area of ​​the inward-curling portion of the proximal arc-shaped unit is connected to a sealing film made of a water-absorbing material, and the sealing film is sealingly connected to the covering film of the main area of ​​the main support.

[0022] In some technical solutions of the present application, the branch openings include two, one of which is the embedded branch opening, and the other is a broken membrane branch opening with an open membrane connected inside; or, the branch openings include a first branch opening, a second branch opening, and a third branch opening arranged in sequence from the axial proximal end to the distal end, the first branch opening is a pure window-type branch opening or is connected to a branch stent extending toward the outside of the main stent, one of the second branch opening and the third branch opening is the embedded branch opening, and the other is connected to an open membrane to form a broken membrane branch opening;

[0023] in:

[0024] The coating of the main support includes a circumferential coating provided in the non-branch opening area of ​​the circumferential surface of the main support and the opening coating, and the weaving density of the opening coating is less than the weaving density of the circumferential coating; the main area of ​​the main support also includes a membrane-breaking area support ring, and the membrane-breaking area support ring includes a parabolic area passing through the membrane-breaking branch opening along the circumferential direction, and the parabolic area is supported on the inner side surface of the opening coating, or the parabolic area is fixedly connected to the opening coating.

[0025] In this optional solution, further optionally, the branch opening includes a first branch opening, a second branch opening and a third branch opening arranged in sequence from the axial proximal end to the distal end, the first branch opening is a pure window-type branch opening or is connected to a branch stent extending toward the outside of the main stent, the second branch opening is the embedded branch opening, and the third branch opening is the membrane-breaking branch opening;

[0026] The main region of the main stent also includes a first section stent ring, a second section stent ring and a third section stent ring which are located on the proximal side of the stent ring in the membrane rupture region and are arranged in sequence from the proximal end to the distal end along the axial direction. The side on which the branch opening is provided on the main stent is the large curvature side of the main stent, the opposite side of the branch opening is the small curvature side of the main stent, and the proximal direction is the upper end and the distal direction is the lower end, then:

[0027] The first branch opening is located between the first bracket ring and the second bracket ring, the wave crests of the first bracket ring are flush, the wave heights of the small curve side are consistent, and the wave heights of the large curve side are lower than the wave heights of the small curve side;

[0028] The second branch opening is located between the second bracket ring and the third bracket ring, the wave troughs of the second bracket ring are flush, the wave heights of the small curve side are consistent, and the wave heights of the large curve side are smaller than the wave heights of the small curve side;

[0029] A partial area of ​​the third branch opening is located between the third section stent ring and the membrane rupture area stent ring, the wave height of the small curve side of the third section stent ring is consistent, the wave height of the large curve side is smaller than the wave height of the small curve side, the wave peak of the large curve side is lower than the wave peak of the small curve side, and the wave trough of the large curve side is higher than the wave trough of the small curve side;

[0030] In the first section stent ring, the second section stent ring, the third section stent ring and the membrane rupture region stent ring, the troughs on the small bend sides of two adjacent stent rings are axially arranged opposite to each other.

[0031] In some technical solutions of the present application, there are two branch openings, and both of the branch openings are the embedded branch openings, or, one branch opening is the embedded branch opening, and the other branch opening is a pure window-type branch opening or is connected to a branch bracket extending toward the outside of the main bracket.

[0032] In some technical solutions of the present application, the branch opening includes a first branch opening, a second branch opening and a third branch opening arranged in sequence from the axial proximal end to the distal end, and the first branch opening is a pure window-type branch opening or is connected to a branch stent extending toward the outside of the main stent.

[0033] And: the second branch opening and the third branch opening are both the embedded branch openings; or, one of the second branch opening and the third branch opening is the embedded branch opening, and the other is a pure window-type branch opening or is connected to a branch bracket extending toward the outside of the main bracket.

[0034] The aortic stent graft provided in this application can at least achieve the following beneficial effects:

[0035] By providing an embedded branch opening, the embedded branch opening and the corresponding embedded stent meet the following requirements: the embedded stent includes a straight section and a curved section connected to each other in the axial direction, the straight section and the curved section are both coated stents, the circumferential surfaces of the two are sealed and connected, and the inner cavities are interconnected; the end surface of the straight section away from one end of the curved section forms a first embedded opening, and the end surface of the curved section away from one end of the straight section forms a second embedded opening; the straight section is parallel to and fixedly connected to the main stent, and there is a gap between the outer circumferential surface of the straight section and any branch opening area of ​​the main stent; the curved section is bent toward the embedded branch opening, and the edge of the second embedded opening is connected to the edge of the embedded branch opening, at least alleviating the problems existing in the existing supra-aortic branch interventional surgery described in the background technology of the present application: ① difficulty in selecting a branch guidewire, ② small operating space for selecting a branch guidewire, and ③ affecting the hemodynamics of the aortic arch. In addition, the straight section of the embedded stent is parallel to and fixedly connected to the main stent, so that the part of the embedded stent inside the main stent can be positioned to prevent the embedded stent from deviating from the preset position under the hemodynamics after implantation and blocking the openings of adjacent branch vessels. When the first embedded opening of the straight section of the embedded stent is facing the proximal side, it can also ensure the smooth flow of blood and ensure the normal blood supply to the branch vessels.

[0036] Other problems existing in the existing supra-arcuate branch interventional surgery described in the background technology are solved by the above-mentioned multiple further optional technical solutions of the present application, and specific reference is made to the explanations in the specific embodiments of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0038] Figure 1 This is a simplified diagram of the structure of the branch blood vessels of the human thoracic aortic arch;

[0039] Figure 2 A schematic diagram of the "bird's beak effect" after implantation of an aortic stent graft in the prior art;

[0040] Figure 3 An axonometric diagram of the overall structural appearance of an aortic stent graft in a natural state and after being implanted in a human body, provided in an optional implementation manner of an embodiment of the present invention;

[0041] Figure 4An axonometric view of the overall structural appearance of an aortic stent graft in a delivery state provided in an optional implementation manner of an embodiment of the present invention;

[0042] Figure 5 for Figure 4 The schematic diagram of the overall structure of the pre-bent tube in the aortic stent graft is shown;

[0043] Figure 6 for Figure 4 A perspective view of the local structure of the proximal side of the aortic covered stent is shown;

[0044] Figure 7 An overall structural diagram of a coronal end stent in an aortic stent graft provided in an optional implementation manner of an embodiment of the present invention;

[0045] Figure 8 for Figure 7 Bottom view of

[0046] Fig. 9 A perspective view of the local structure of the aortic stent graft from the proximal end of the main body to the main body region in the delivery state provided by an optional implementation manner of the embodiment of the present invention;

[0047] Fig.10 for Fig. 9 A partial side view of the structure shown, wherein the branch support is not shown;

[0048] Fig.11 for Fig. 9 Axonometric diagram of the overall structure of the embedded stent in the aortic stent graft shown Figure 1 ;

[0049] Fig.12 for Fig. 9 Axonometric diagram of the overall structure of the embedded stent in the aortic stent graft shown Figure 2 .

[0050] Icons: 11- aortic arch vessels; 12- ascending aorta vessels; 13- descending aorta vessels; 14- innominate artery vessels; 15- left common carotid artery vessels; 16- left subclavian artery vessels;

[0051] 2-main body support; 21-crown end support; 211-proximal arc unit; 212-sealing membrane; 213-distal arc unit; 22-first section support ring; 23-second section support ring; 24-third section support ring; 25-broken membrane area support ring; 201-first branch opening; 202-second branch opening; 203-third branch opening;

[0052] 3-Branch bracket;

[0053] 4-embedded bracket; 401-first embedded opening; 402-second embedded opening; 41-straight section; 42-bent section; 421-elbow section; 422-eccentric cone section;

[0054] 5- Pre-bend the pipe. DETAILED DESCRIPTION

[0055] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0056] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0057] It should be noted that like reference numerals and letters denote similar items in the drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0058] In the description of the present invention, it should be noted that:

[0059] Unless otherwise clearly specified and limited, the terms "disposed", "installed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0060] The orientation or positional relationship indicated by the terms "proximal", "distal", "axial", "radial", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or is the orientation or positional relationship in which the product of the invention is usually placed when used. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0061] In the following, some embodiments of the present invention are described in detail in conjunction with the accompanying drawings. In the absence of conflict, the features of the following embodiments and the optional embodiments in the embodiments can be combined with each other.

[0062] like Figure 1 As shown, the structure of the human thoracic aorta mainly includes the aortic arch blood vessels 11, the ascending aorta blood vessels 12, and the descending aorta blood vessels 13. The convex side of the aortic arch blood vessels 11 is its greater curvature side, and the concave side is its lesser curvature side. There are three branch blood vessels on the greater curvature side, which are the innominate artery blood vessels 14 (also known as the brachiocephalic trunk artery blood vessels), the left common carotid artery blood vessels 15 and the left subclavian artery blood vessels 16. Some dissections or aneurysm lesions may occur in the aortic arch blood vessels 11. At this time, it is necessary to implant an aortic covered stent in the aortic arch blood vessels 11 for treatment. When the lesions involve the branch blood vessels, in addition to implanting the aortic covered stent, it is also necessary to implant a branch stent into the corresponding branch blood vessels. The implanted aortic covered stent and branch stent should not block the branch blood vessels to maintain blood supply.

[0063] The present application provides an aortic stent graft, referring to Figures 3 to 12 In the implanted state, the end of the main stent 2 in the aortic covered stent facing the ascending aortic vessel 12 is its proximal end, and the end facing the descending aortic vessel 13 is its distal end. The aortic covered stent provided in the present application includes a main stent 2 and an embedded stent 4, the embedded stent 4 is a covered stent, and the main stent 2 at least includes a main body area with a covered film connected to the circumference, and at least one branch opening is opened in the film on the side of the main body area of ​​the main stent 2, wherein the embedded stent 4 is connected inside at least one branch opening to form an embedded branch opening. Specifically, the main stent 2 of the aortic covered stent has a variety of branch opening opening methods, mainly including:

[0064] In a first optional opening method, a branch opening is opened on the main stent 2, and an embedded stent 4 is connected inside the branch opening to form an embedded branch opening. The main stent 2 is implanted into the human body from the descending aorta 13, so that the embedded branch opening is aligned with the branch vessel opening where the left subclavian artery 16 is located, and the proximal end of the main stent 2 does not block the branch vessel opening where the left common carotid artery 15 is located and the branch vessel opening where the innominate artery 14 is located;

[0065] In a second optional opening method, two branch openings are opened on the main stent 2, and at least one of the two branch openings is connected to an embedded stent 4 to form an embedded branch opening. The main stent 2 is implanted into the human body from the descending aorta 13, so that the branch opening on the distal side is aligned with the branch blood vessel opening where the left subclavian artery 16 is located, and the branch opening on the proximal side is aligned with the branch blood vessel opening where the left common carotid artery 15 is located, and the proximal end of the main stent 2 does not block the branch blood vessel opening where the innominate artery 14 is located;

[0066] A third optional opening method is to open three branch openings on the main stent 2, among which at least one branch opening is internally connected with an embedded stent 4 to form an embedded branch opening, and the main stent 2 is implanted into the human body from the descending aorta 13, from the proximal side to the distal side, the first branch opening 201 is aligned with the branch vessel opening where the innominate artery 14 is located, the second branch opening 202 is aligned with the branch vessel opening where the left common carotid artery 15 is located, and the third branch opening 203 is aligned with the branch vessel opening where the left subclavian artery 16 is located.

[0067] Furthermore, the above-mentioned embedded branch opening and the corresponding embedded bracket 4 connected thereto satisfy: the embedded bracket 4 includes a straight section 41 and a curved section 42 which are mutually connected in the axial direction, the straight section 41 and the curved section 42 are both coated brackets, the circumferential surfaces of the two are sealed and connected, and the inner cavities are interconnected; the end surface of the straight section 41 away from the curved section 42 forms a first embedded opening 401, and the end surface of the curved section 42 away from the straight section 41 forms a second embedded opening 402; the straight section 41 is parallel to and fixedly connected to the main bracket 2, and there is a gap between the outer circumferential surface of the straight section 41 and any branch opening area of ​​the main bracket 2; the curved section 42 is bent toward the embedded branch opening, and the edge of the second embedded opening 402 is connected to the edge of the embedded branch opening.

[0068] After the main stent 2 is implanted into the human body from the descending aorta 13, for the embedded branch opening, a branch guidewire can be passed from the corresponding branch vessel to select the branch guidewire into the embedded stent 4, and then the branch stent is further implanted from the descending aorta 13 into the corresponding branch vessel along the branch guidewire to complete the interventional surgery. When the branch guidewire is passed from the corresponding branch vessel into the inside of the main stent 2 (i.e., into the aorta), due to the above-mentioned bent embedded stent 4, the branch guidewire can be guided by the bending section 42 of the embedded stent 4 to be naturally bent after entering the embedded branch opening, without having to separately set a component on the conveyor to control the bending of the branch guidewire head end, and avoid the branch guidewire from the corresponding branch vessel, especially from the left common carotid artery 15. When entering the main stent 2, it is prevented from directly contacting the small curved side of the main stent 2, making the superselection of the branch guidewire easier to operate. In addition, compared with the prior art in which a recessed structure with a very large axial span is directly designed on the large bend side of the main stent 2 to insert a branch guide wire, this structure can ensure that the main stent 2 fits tightly against the vascular wall of the aortic arch blood vessel 11, thereby ensuring that the main stent 2 has a larger support diameter within the lumen of the aortic arch blood vessel 11 and reducing the risk of type I endoleak.

[0069] In particular, when the embedded branch opening is set to align with the branch vessel opening where the left common carotid artery 15 is located, the first embedded opening 401 of the embedded stent 4 is facing the proximal side. When the embedded branch opening is set to align with the branch vessel opening where the left subclavian artery 16 is located, the first embedded opening 401 of the embedded stent 4 can be facing the proximal side or the distal side. When the first embedded opening 401 of the embedded stent 4 is facing the distal side, the branch guide wire should be selected from the femoral artery to the left subclavian artery 16.

[0070] In summary, the aortic stent graft provided by the present application can at least alleviate the problems existing in the existing supra-aortic branch interventional surgery described in the background technology of the present application by providing the above-mentioned embedded stent 4: ① difficulty in selecting the branch guidewire, ② small operating space for selecting the branch guidewire, and ③ affecting the hemodynamics of the aortic arch. In addition, the straight section 41 of the embedded stent 4 is parallel to and fixedly connected to the main stent 2, and the part of the embedded stent 4 inside the main stent 2 can be positioned to prevent the embedded stent 4 from deviating from the preset position under the hemodynamics after implantation to block the opening of the adjacent branch blood vessels. When the first embedded opening 401 of the straight section 41 of the embedded stent 4 faces the proximal side, it can also ensure the smooth flow of blood and ensure the normal blood supply to the branch blood vessels.

[0071] Based on this, the present application has several further optional technical solutions:

[0072] In the optional technical solution of this application, refer to Fig.11 and Fig.12 In the above-mentioned embedded stent 4, its curved section 42 includes an elbow section 421 and an eccentric cone section 422, the elbow section 421 and the eccentric cone section 422 are sealed and connected to each other and their inner cavities are interconnected; the end of the elbow section 421 away from the eccentric cone section 422 is connected to the end of the straight section 41 away from the first embedded opening 401, the diameter of the eccentric cone section 422 gradually increases from the end connected to the elbow section 421 toward the end away from the elbow section 421, and the elliptical end surface of the end of the eccentric cone section 422 away from the elbow section 421 forms a second embedded opening 402. With this structure, when the branch guide wire is selected from the corresponding branch blood vessel into the main stent 2 (i.e., selected into the aortic blood vessel), the second embedded opening 402 serves as the guide wire selection end, has a larger opening area, maximizes the range of the branch guide wire selection, and makes the branch guide wire selection easier.

[0073] In order to further increase the operating space for the branch guidewire to be selected from the corresponding branch blood vessel into the main stent 2 (i.e., into the aortic blood vessel), in the optional technical solution of the present application, in the main stent 2, the area where the embedded branch opening is located is recessed toward the inner cavity of the main stent 2 relative to other parts of the circumference of the main stent 2, thereby further reducing the difficulty of selecting the branch guidewire. In particular, the recessed area is limited to the area where the embedded branch opening is located, which should be distinguished from the recessed structure with a very large axial span designed directly on the large curved side of the main stent 2 in the prior art.

[0074] refer to Figure 2 , for the existing problems of the "bird's beak effect" of the thoracic aortic stent graft in the existing supra-aortic branch interventional surgery, in the optional technical solutions of this application, such as Figure 3 , Figure 5 and Fig. 9 , Fig.10 As shown, the aortic stent graft also includes a pre-bent tube 5 that is pre-bent into an arc shape and has elasticity; the pre-bent tube 5 is fixedly connected to the main stent 2 along the axial direction of the main stent 2, and the pre-bent tube 5 can rebound when the main stent 2 is freely released, so as to bend the main stent 2 into a bending shape with the branch opening located on the large curve side and the opposite side of the branch opening located on the small curve side. In this technical solution, during the implantation of the aortic stent graft into the aortic arch blood vessel 11, the pre-bent tube 5 can be controlled by passing a straight hard wire inside the pre-bent tube 5 to present a curved shape during the delivery process. Figure 4 In the straight state shown, it is loaded in the conveyor. After being transported to the right place, the aortic covered stent is released from the conveyor, and the straight hard wire is withdrawn to make the main stent 2 of the aortic covered stent bend under the rebound force of the pre-bent tube 5. Then the main stent 2 is closely fitted to the vascular wall of the aortic arch blood vessel 11, avoiding the "bird's beak effect" on the small bend side of the main stent 2 and reducing the probability of type I internal leakage.

[0075] For the existing problems of supra-aortic branch intervention surgery: ⑤ ascending aortic reverse tear dissection, in the optional technical solutions of this application, such as Figure 3 , Figure 4 as well as Figures 6 to 9As shown, the proximal region of the main support 2 is designed to be a corolla-shaped end support 21; the corolla-shaped end support 21 includes a plurality of proximal arc units 211 and a plurality of distal arc units 213, wherein a single proximal arc unit 211 and a single distal arc unit 213 are opposite in axial opening direction and arranged staggered with each other in the circumferential direction and connected end to end; the bending radius of the proximal arc unit 211 is greater than the bending radius of the distal arc unit 213, and the arc region of the proximal arc unit 211 is bent radially toward the inner region of the skeleton in an inward-bending shape. In this optional scheme, further optionally, in the main support 2, the hollow region of the inward-bending portion of the proximal arc unit 211 in an inward-bending shape is connected to a sealing film 212 made of a water-absorbing material, and the sealing film 212 is sealed and connected to the coating of the main region of the main support 2. In this technical solution, by providing a corolla-shaped end bracket 21, its distal arc unit 213 and its inward-buckling shape can prevent the proximal region of the main bracket 2 from irritating the aortic vascular endothelium as the ascending aorta 12 pulsates after the aortic covered stent is implanted, thereby preventing the occurrence of ascending aortic reverse tearing dissection; further, by providing a sealing membrane 212, the sealing membrane 212 absorbs blood and expands, and the gap between the part where the distal arc unit 213 presents an inward-buckling shape and the aortic vascular endothelium can be sealed, thereby fully avoiding the occurrence of proximal type I internal leakage of the main bracket 2, wherein the sealing membrane 212 can be optionally but not limited to being made of medical gelatin or other absorbent resin materials, and the specific connection method between it and the covering film in the main area of ​​the main bracket 2 can be optionally but not limited to suturing or heat sealing connection.

[0076] In combination with the first to third optional branch opening opening methods of the aortic covered stent main body stent 2 of the present application:

[0077] (I) For the second optional opening mode, that is, when two branch openings are opened on the main support 2, at least the following situations are included:

[0078] (1) Both branch openings are embedded branch openings; (2) One branch opening is an embedded branch opening, and the other branch opening is a pure window branch opening; (3) One branch opening is an embedded branch opening, and the other branch opening is connected to a branch stent 3 extending toward the outside of the main stent 2 for positioning during implantation; (4) One branch opening is an embedded branch opening, and the other branch opening is a membrane-breaking branch opening with an opening membrane inside;

[0079] Further optionally, one of the branch openings is an embedded branch opening, and the other branch opening is a membrane-breaking branch opening with an opening covering connected thereto. Specifically: as an arrangement, the embedded branch opening is located at the proximal side, and corresponds to the branch vessel opening where the left common carotid artery 15 is located after implantation, and the first embedded opening 401 faces the proximal end, and the membrane-breaking branch opening is located at the distal side, and corresponds to the branch vessel opening where the left subclavian artery 16 is located after implantation; as another arrangement, the membrane-breaking branch opening is located at the proximal side, and corresponds to the branch vessel opening where the left common carotid artery 15 is located after implantation, and the embedded branch opening is located at the distal side, and corresponds to the branch vessel opening where the left subclavian artery 16 is located after implantation, and the first embedded opening 401 can face the proximal end or the distal end;

[0080] (II) For the third optional opening mode, that is, the branch openings on the main stent 2 include a first branch opening 201, a second branch opening 202 and a third branch opening 203 arranged in sequence from the axial proximal end to the distal end, including at least the following situations: (1) the first branch opening 201 is a pure window-type branch opening or is connected to a branch stent 3 extending toward the outside of the main stent 2 for positioning during implantation, and the second branch opening 202 and the third branch opening 203 are both embedded branch openings; (2) the first branch opening 201 is a pure window-type branch opening; The window-type branch opening or the branch bracket 3 extending toward the outside of the main bracket 2 is connected to be positioned during implantation. One of the second branch opening 202 and the third branch opening 203 is an embedded branch opening, and the other is a pure window-type branch opening; (3) The first branch opening 201 is a pure window-type branch opening or the branch bracket 3 extending toward the outside of the main bracket 2 is connected to be positioned during implantation. One of the second branch opening 202 and the third branch opening 203 is an embedded branch opening, and the other is connected to a branch bracket 3 extending toward the outside of the main bracket 2. The extended branch stent 3 is used for positioning during implantation; (4) the first branch opening 201 is a pure window-type branch opening or is connected to a branch stent 3 extending toward the outside of the main stent 2 for positioning during implantation, and one of the second branch opening 202 and the third branch opening 203 is an embedded branch opening, and the other is internally connected to an opening covering to form a membrane-breaking branch opening; when it is the case of (4), specifically: as an arrangement mode, the second branch opening 202 is an embedded branch opening, which corresponds to the left common carotid artery 15 after implantation. The branch vessel opening, the first embedded opening 401 is toward the proximal end, the third branch opening 203 is a membrane-breaking branch opening, which corresponds to the branch vessel opening where the left subclavian artery 16 is located after implantation; as another arrangement method, the second branch opening 202 is a membrane-breaking branch opening, which corresponds to the branch vessel opening where the left common carotid artery 15 is located after implantation, the third branch opening 203 is an embedded branch opening, which corresponds to the branch vessel opening where the left subclavian artery 16 is located after implantation, and the first embedded opening 401 can be toward the proximal end or toward the distal end.

[0081] The membrane-breaking branch opening structures involved in the above-mentioned opening methods are specifically described as follows:

[0082] The coating of the main support 2 includes a circumferential coating arranged in the non-branch opening area of ​​the circumferential surface of the main support 2 and an opening coating connected to the membrane-breaking branch opening area, and the weaving density of the opening coating is less than the weaving density of the circumferential coating; the main area of ​​the main support 2 also includes a membrane-breaking area support ring 25, and the membrane-breaking area support ring 25 includes a parabolic area passing through the membrane-breaking branch opening along the circumferential direction, and the parabolic area is supported on the inner side of the aforementioned opening coating, or the parabolic area is fixedly connected to the opening coating. In this structure, the membrane can be ruptured by a membrane rupture guide wire or other devices. When rupturing the membrane, the membrane rupture guide wire passes through the gap of the open membrane coating braided wire to achieve in situ windowing of the main stent 2 at the position of the left common carotid artery 15 or the left subclavian artery 16. The parabolic area of ​​the stent ring 25 in the membrane rupture area can support the membrane rupture area to the greatest extent, while increasing the radial support performance of the main stent 2 inside the aortic arch blood vessel 11, improving the wall adhesion of the main stent 2 to avoid internal leakage, and avoiding displacement of the main stent 2 during the membrane rupture process.

[0083] In the above-mentioned multiple specific optional technical solutions of the present application, when the branch opening includes a first branch opening 201, a second branch opening 202 and a third branch opening 203 arranged in sequence from the axial proximal end to the distal end, the first branch opening 201 is a pure window-type branch opening or is connected to a branch stent 3 extending toward the outside of the main stent 2 for positioning during implantation, the second branch opening 202 is an embedded branch opening, the third branch opening 203 is a membrane-breaking branch opening, and a membrane-breaking region stent ring 25 is provided, it is further optional:

[0084] like Fig. 9 and Fig.10As shown, the main area of ​​the main stent 2 also includes a first section stent ring 22, a second section stent ring 23 and a third section stent ring 24 which are located on the proximal side of the stent ring 25 in the membrane rupture area and are arranged in sequence along the axial direction from the proximal end to the distal end in a wavy manner; wherein, the side on which the branch opening is provided on the main stent 2 is the large bend side of the main stent 2, the opposite side of the branch opening is the small bend side of the main stent 2, and the proximal direction is the upper end, and the distal direction is the lower end, then: the first branch opening 201 is located between the first section stent ring 22 and the second section stent ring 23, the wave crests of the first section stent ring 22 are flush, the wave heights on the small bend side are consistent, and the wave heights on the large bend side are lower than the wave heights on the small bend side; the second branch opening The opening 202 is located between the second-section support ring 23 and the third-section support ring 24, the troughs of the second-section support ring 23 are flush, the wave heights on the small curve side are consistent, and the wave heights on the large curve side are smaller than the wave heights on the small curve side; a partial area of ​​the third branch opening 203 is located between the third-section support ring 24 and the membrane-breaking region support ring 25, the wave heights on the small curve side of the third-section support ring 24 are consistent, the wave heights on the large curve side are smaller than the wave heights on the small curve side, the wave crests on the large curve side are lower than the wave crests on the small curve side, and the wave troughs on the large curve side are higher than the wave troughs on the small curve side; in the first-section support ring 22, the second-section support ring 23, the third-section support ring 24 and the membrane-breaking region support ring 25, the wave troughs on the small curve sides of two adjacent support rings are axially arranged relative to each other.

[0085] Through the mutual cooperation of the above-mentioned four stent rings, this technical solution ensures that the main stent 2 can be fully expanded in the aortic arch blood vessel 11, so that the main stent 2 fits well with the aortic arch blood vessel endothelium, and ensures the overall flexibility of the main stent 2, while ensuring smooth blood flow inside the main stent 2 and the stability of blood flow dynamics.

[0086] Finally, it should be noted that:

[0087] 1. The structures shown in the drawings of this embodiment only represent an optional specific implementation of this embodiment. The structure can be deformed. For the specific deformable structure, refer to the relevant description of the specific implementation of this specification;

[0088] 2. The above embodiments and optional implementation modes in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit them. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above optional implementation modes, or replace part or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that the features of the embodiments in this specification and the optional implementation modes in the embodiments can be combined with each other without conflict.

Claims

1. An aortic stent graft, characterized in that: It comprises a main support (2) and an embedded support (4), wherein the embedded support (4) is a coated support; The main body support (2) comprises at least a main body region with a coating connected to the circumferential surface, and the coating on the side of the main body region is provided with at least one branch opening, wherein the embedded support (4) is connected to the inside of at least one branch opening to form an embedded branch opening, and the embedded branch opening and the correspondingly connected embedded support (4) meet the following requirements: The embedded stent (4) comprises a straight section (41) and a curved section (42) which are connected to each other in the axial direction. The straight section (41) and the curved section (42) are both coated stents. The circumferential surfaces of the two sections are sealed and connected, and the inner cavities are interconnected. The end surface of the straight section (41) away from the curved section (42) forms a first embedded opening (401), and the end surface of the curved section (42) away from the straight section (41) forms a second embedded opening (402). The straight section (41) is parallel to and fixedly connected to the main stent (2), and there is a gap between the outer circumferential surface of the straight section (41) and any branch opening area of ​​the main stent (2). The curved section (42) is bent toward the embedded branch opening, and the edge of the second embedded opening (402) is connected to the edge of the embedded branch opening. The proximal region of the main body support (2) is a corolla-shaped end support (21); The corolla-shaped end bracket (21) comprises a plurality of proximal arc-shaped units (211) and a plurality of distal arc-shaped units (213), wherein a single proximal arc-shaped unit (211) and a single distal arc-shaped unit (213) are arranged in opposite directions along the axial opening direction and are interlaced with each other along the circumferential direction and connected end to end; the bending radius of the proximal arc-shaped unit (211) is greater than the bending radius of the distal arc-shaped unit (213), and the arc region of the proximal arc-shaped unit (211) is bent radially toward the inner region of the main bracket (2) to form an inward buckling shape; In the main support (2), a sealing film (212) made of a water-absorbing material is connected to the hollowed-out area of ​​the inwardly buckled portion of the proximal arc-shaped unit (211), and the sealing film (212) is sealingly connected to the coating of the main region of the main support (2).

2. The aortic stent graft according to claim 1, characterized in that: In the embedded bracket (4), the curved section (42) comprises an elbow section (421) and an eccentric frustum section (422) whose circumferential surfaces are sealed and whose inner cavities are interconnected; One end of the elbow section (421) away from the eccentric frustum section (422) is connected to one end of the straight tube section (41) away from the first embedded opening (401); the diameter of the eccentric frustum section (422) gradually increases from the end connected to the elbow section (421) toward the end away from the elbow section (421); and the elliptical end surface of the end of the eccentric frustum section (422) away from the elbow section (421) forms the second embedded opening (402).

3. The aortic stent graft according to claim 1, characterized in that: In the main body support (2), the area where the embedded branch opening is located is recessed towards the inner cavity of the main body support (2) relative to other parts of the circumference of the main body support (2).

4. The aortic stent graft according to claim 1, characterized in that: The aortic stent graft also includes a pre-bent tube (5) that is pre-bent into an arc shape and has elasticity; The pre-bent tube (5) is fixedly connected to the main body support (2) along the axial direction of the main body support (2), and the pre-bent tube (5) is capable of rebounding when the main body support (2) is in a freely released state, so as to bend the main body support (2) into a bent state in which the branch opening is located on the large bend side and the opposite side of the branch opening is located on the small bend side.

5. The aortic stent graft according to claim 1, characterized in that: The branch openings include two, one of which is the embedded branch opening, and the other is a membrane-breaking branch opening with an opening coating connected to the inside; or, the branch openings include a first branch opening (201), a second branch opening (202), and a third branch opening (203) arranged in sequence from the axial proximal end to the distal end, the first branch opening (201) being a pure window-type branch opening or being connected to a branch stent (3) extending toward the outside of the main stent (2), and one of the second branch opening (202) and the third branch opening (203) being the embedded branch opening, and the other being connected to an opening coating to form a membrane-breaking branch opening; in: The coating of the main stent (2) comprises a circumferential coating provided in a non-branch opening area of ​​the circumferential surface of the main stent (2) and the opening coating, wherein the weaving density of the opening coating is less than the weaving density of the circumferential coating; the main area of ​​the main stent (2) further comprises a membrane-breaking area stent ring (25), wherein the membrane-breaking area stent ring (25) comprises a parabolic area passing through the membrane-breaking branch opening along the circumferential direction, wherein the parabolic area is supported on the inner side surface of the opening coating, or the parabolic area is fixedly connected to the opening coating.

6. The aortic stent graft according to claim 5, characterized in that: The branch openings include a first branch opening (201), a second branch opening (202), and a third branch opening (203) arranged in sequence along the axial proximal to distal direction, the first branch opening (201) being a pure window-type branch opening or being connected to a branch stent (3) extending toward the outside of the main stent (2), the second branch opening (202) being the embedded branch opening, and the third branch opening (203) being the membrane-breaking branch opening; The main region of the main stent (2) further comprises a first section stent ring (22), a second section stent ring (23) and a third section stent ring (24) which are located on the proximal side of the membrane rupture region stent ring (25) and are arranged in sequence along the axial direction from the proximal end to the distal end; wherein the side of the main stent (2) on which the branch opening is provided is the large curvature side of the main stent (2), the opposite side of the branch opening is the small curvature side of the main stent (2), and the proximal direction is the upper end and the distal direction is the lower end, then: The first branch opening (201) is located between the first bracket ring (22) and the second bracket ring (23); the wave crests of the first bracket ring (22) are flush, the wave heights of the small bend side are consistent, and the wave height of the large bend side is lower than that of the small bend side; The second branch opening (202) is located between the second bracket ring (23) and the third bracket ring (24); the wave troughs of the second bracket ring (23) are flush, the wave heights on the small bend side are consistent, and the wave heights on the large bend side are smaller than the wave heights on the small bend side; A partial area of ​​the third branch opening (203) is located between the third section stent ring (24) and the membrane rupture area stent ring (25), the wave height of the small curve side of the third section stent ring (24) is consistent, the wave height of the large curve side is smaller than the wave height of the small curve side, the wave crest of the large curve side is lower than the wave crest of the small curve side, and the wave trough of the large curve side is higher than the wave trough of the small curve side; In the first-section stent ring (22), the second-section stent ring (23), the third-section stent ring (24) and the membrane-breaking region stent ring (25), the troughs on the small-bend sides of two adjacent stent rings are axially arranged opposite to each other.

7. The aortic stent graft according to any one of claims 1 to 4, characterized in that: There are two branch openings, and both of the branch openings are the embedded branch openings, or one of the branch openings is the embedded branch opening, and the other branch opening is a pure window-type branch opening or is connected to a branch bracket (3) extending toward the outside of the main bracket (2).

8. The aortic stent graft according to any one of claims 1 to 4, characterized in that: The branch openings comprise a first branch opening (201), a second branch opening (202) and a third branch opening (203) arranged in sequence along the axial proximal to distal direction, wherein the first branch opening (201) is a pure window-type branch opening or is connected to a branch stent (3) extending toward the outside of the main stent (2); as well as: The second branch opening (202) and the third branch opening (203) are both embedded branch openings; Alternatively, one of the second branch opening (202) and the third branch opening (203) is the embedded branch opening, and the other is a pure window-type branch opening or is connected to a branch bracket (3) extending toward the outside of the main bracket (2).

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