Plugging support and plugging system

Abstract

The invention relates to a plugging stent and a plugging system.The plugging stent comprises a covered stent and a one-way valve component, the one-way valve component is arranged in a hollow cavity or / and an extension cavity of the covered stent, and the one-way valve component comprises a connecting section and a free section which are connected; one end, far away from the free section, of the connecting section is connected to the covered stent in the circumferential direction, the blocking stent further comprises a self-recovery structure arranged on the free section, the end, far away from the connecting section, of the self-recovery structure comprises a curled part, and the curled part has a shape memory function. According to the plugging support, due to the design of the self-recovery curled edge, the closing reliability can be improved, and meanwhile the plugging effect is better on the basis that the complexity of surgical operation is not increased, and the surgical time is not increased.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a closure stent and a closure system for a false lumen of aortic dissection. Background Art

[0002] Aortic dissection (AD) refers to the blood in the aorta cavity entering the aortic media 1003b from the tear of the aortic intima 1003a, causing the media 1003b to separate from the intima 1003a and the outer wall 1003c (refer to Figure 8 The aortic dissection is a pathological change in which the aortic lumen 1001 and the false lumen 1002 are formed by the expansion of the aortic lumen along the long axis of the aorta. Currently, thoracic endovascular aortic repair (TEVAR) has become a commonly used surgical method for the treatment of aortic dissection in clinic due to its low mortality and morbidity.

[0003] However, after TEVAR, due to factors such as the pressure difference between the true and false lumens, vascular morphology, and the physical properties of the implanted stent, stent-induced new entry (SINE) may occur. In 20%-30% of patients, SINE may occur in the false lumen due to the distal end of the stent after TEVAR, and blood may flow back through the distal SINE. Figure 1 The false lumen 1002 is entered into the false lumen 1002, causing the false lumen to continue to expand or even rupture. Figure 1 shown. Summary of the invention

[0004] A technical problem solved by the present invention is how to provide a blocking stent with good blocking effect to prevent blood reflux without increasing the complexity of the operation.

[0005] The present invention provides an occluding stent, which includes a coated stent and a one-way valve component, wherein the one-way valve component is arranged in the hollow cavity of the coated stent and / or its extended cavity, and the one-way valve component includes a connected connecting segment and a free segment, wherein one end of the connecting segment away from the free segment is circumferentially connected to the coated stent, and the occluding stent also includes a self-restoring structure arranged on the free segment, and the end of the self-restoring structure away from the connecting segment includes a curling portion, and the curling portion has a shape memory function.

[0006] A technical effect of an embodiment of the present invention is that by setting a self-restoring structure, the distal end of the one-way valve component is curled and sealed under the self-restoring action of the self-restoring structure. The design of the self-restoring curling edge can increase the reliability of closure, while at the same time achieving a better sealing effect without increasing the complexity of the surgical operation and the operation time.

[0007] On the other hand, the present invention also provides an occlusion system, comprising a delivery device and an occlusion stent as described above, wherein the delivery device comprises a sheath-core assembly and a sheath tube, and the distal end of the one-way valve component is in an open state, allowing the sheath-core assembly to penetrate from the distal end of the one-way valve component and pass out from the proximal end of the one-way valve component. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 It is a schematic diagram of the false lumen in the background technology being impacted by blood flow backflow due to the distal rupture;

[0009] Figure 2 A three-dimensional structural diagram of the occluding stent provided by the present invention;

[0010] Figure 3 A three-dimensional structural diagram of the occlusion stent provided by the present invention (showing a one-way valve component);

[0011] Figure 4 for Figure 3 The cross-sectional view along the AA direction;

[0012] Figure 5 A three-dimensional structural diagram of the one-way valve component provided by the present invention;

[0013] Figure 6 A schematic diagram of two membranes constituting a one-way valve component provided by the present invention being unfolded along a plane when not fixed to a stent graft;

[0014] Figure 7 This is a schematic diagram of implanting the occluding stent provided by the present invention into a false lumen to prevent blood from flowing back into the false lumen;

[0015] Figure 8 A top view of the blocking stent provided by the present invention when it matches the main chest stent (with Figure 7 For reference of normal viewing angle);

[0016] Fig. 9 This is a schematic diagram of the extension direction of the line L5 when the occluding stent provided by the present invention is not implanted in the false lumen and is naturally expanded in a top view;

[0017] Fig.10 This is a schematic diagram from a top view when the direction F (F') of the radial extrusion force of the main chest stent on the occluding stent provided by the present invention is consistent with the direction of the connecting line L5;

[0018] Fig.11 A three-dimensional structural diagram of the middle occluding stent provided by the present invention (showing a one-way valve component);

[0019] Fig.12 A schematic diagram of a one-way valve component and a self-restoring structure provided by the present invention;

[0020] Fig.13 A side view of the one-way valve component and the self-restoring structure provided by the present invention;

[0021] Fig.14 A side view of the self-restoring structure provided by the present invention;

[0022] Fig.15 A side view schematic diagram of a one-way valve component of the occluding stent provided by the present invention being passed through by a sheath core;

[0023] Fig.16 Schematic diagram of other embodiments of the self-restoring structure and the one-way valve component provided by the present invention in a natural state;

[0024] Fig.17 for Fig.16 A magnified image of the self-healing structure in its natural state;

[0025] Fig.18 Schematic diagram of other embodiments of the self-healing structure (network structure) provided by the present invention in a natural state;

[0026] Fig.19 for Fig.18 Schematic diagram of other embodiments of the self-restoring structure and the one-way valve component in a natural state;

[0027] Fig. 20 A schematic diagram of the self-restoring structure provided by the present invention comprising two curled mesh structures (the first curled structure is not shown) and a one-way valve component in a natural state;

[0028] Fig.21 A side view of the self-restoring structure provided by the present invention including two curled mesh structures and a one-way valve component in a natural state;

[0029] Fig. 22 A schematic diagram showing that the occluding stent provided by the present invention is loaded in a conveying device, and the conveying device is loaded with the occluding stent (conveying system) and conveys the occluding stent to a location to be released in a false cavity;

[0030] Fig.23 A schematic diagram of a state in which the self-restoring structure provided by the present invention includes two curled mesh structures and the stent graft is partially released and expanded after the sheath is withdrawn to the stent graft (the self-restoring structure of the one-way valve component is in an unnatural state of axial expansion due to the sheath core component passing through the one-way valve component);

[0031] Fig.24The self-restoring structure provided by the present invention includes two curled mesh structures when the occluding stent, the sheath tube is withdrawn to the distal side of the coated stent (the self-restoring structure of the one-way valve component is in an unnatural state of axial expansion due to the sheath core component passing through the one-way valve component);

[0032] Fig.25 A schematic diagram of the occluding stent when the self-restoring structure provided by the present invention includes two curled mesh structures, and the tip head of the sheath-core assembly is withdrawn from the one-way valve component;

[0033] Fig.26 A schematic diagram of the structure of the conveying system provided by the present invention;

[0034] Fig. 27 This is a schematic diagram of the delivery system provided by the present invention releasing the occluding stent into the false lumen. DETAILED DESCRIPTION

[0035] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thoroughly understood.

[0036] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "inside", "outside", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.

[0037] "Axial" generally refers to the length direction of the medical device when it is transported, "radial" generally refers to the direction of the medical device that is perpendicular to its "axial direction" and passes through the center of the lumen, and "transverse" generally refers to the direction of the medical device that is perpendicular to its "axial direction"; and the "axial", "radial" and "transverse" of any component of the medical device are defined based on this principle. In addition, when describing the lumen stent or covered stent in the true lumen, the orientation can be defined according to the blood flow direction in the blood vessel. In the present invention, the blood flow is defined as flowing from the proximal end to the distal end of the main thoracic stent in the true lumen; since the blood flow breach described in the present invention is at the distal end of the main thoracic stent, the blood flow direction from the distal breach into the false lumen is defined as from the distal end of the occluding stent toward its proximal end. The blood flow flowing from the distal breach into the false lumen impacts the distal end of the one-way valve component due to the occluding effect of the occluding stent.

[0038] The present invention provides a blocking stent 100 and a blocking system, such as Figure 2-27As shown, the occluding stent 100 includes a coated stent 10 and a one-way valve component 20, which can be used to be implanted in a false lumen caused by type B aortic dissection to prevent the distal end of the false lumen from tearing and causing blood to flow back into the false lumen, thereby causing the false lumen to continue to expand or even rupture. It can also be used in other blood vessel cavities that need to be blocked to prevent blood from flowing back.

[0039] like Figure 2-4 As shown, the stent graft 10 is a tubular structure with openings at both ends. The stent graft 10 includes a main wave coil 11 and a coating 12. The coating 12 is arranged on the main wave coil 11, wherein the main wave coil 11 includes a plurality of main wave coils 11, which are arranged axially and connected by the tubular coating 12. The main wave coils 11 can be set to 2-14, and the axial length range of the stent graft 10 is 30mm-140mm. In this embodiment, taking the false cavity caused by the implantation of the occluding stent 100 in aortic dissection as an example, the main wave coil 11 can be arranged on the outside of the coating 12. When implanted, the friction between the stent and the inner wall of the false cavity can be increased, which is conducive to preventing the occluding stent 100 from shifting or shortening relative to the inner wall of the false cavity. In other embodiments, the main wave coil 11 can also be arranged on the inner side of the coating 12, or the main wave coil 11 is partially arranged on the inner side of the coating 12 and partially arranged on the outer side of the coating 12, which is not limited here.

[0040] like Figure 3-6 As shown, the one-way valve component 20 includes a connecting segment 21 and a free segment 22. The end of the connecting segment 21 away from the free segment 22 is circumferentially connected to the coated stent 10. The one-way valve component 20 is arranged in the hollow cavity of the coated stent 10 or / and its extended cavity. The extended cavity refers to a cavity formed by axial extension along the end of the coating 12, that is, except for the proximal connection position of the connecting segment 21, the other parts of the one-way valve component 20 can be arranged in the hollow cavity of the coated stent 10 or beyond the distal end of the coating 12.

[0041] like Figure 3-6 As shown, the one-way valve component 20 includes at least two membranes, and the adjacent edges of at least two membranes are connected to each other to form a funnel-shaped structure; when not sutured to the stent graft 10, the membrane is a planar structure, such as Figure 6 As shown, the two diaphragms have the same shape and can be an integral structure (such as Figure 6The two diaphragms shown are connected by a connection point), or they can be a split structure (two completely separated diaphragms), which is not limited here. After the axial edges of the two planar diaphragms are sutured in pairs, the two diaphragms are attached to each other, and then the large end of the connecting section is stretched open and sutured in a circular ring shape to the inner side of the proximal end of the coated stent, so that the adjacent edges of the two diaphragms are connected to each other to form an axially symmetrical structure of a funnel-shaped structure; at this time, from the large end of the connecting section toward the small end, the two diaphragms gradually approach each other, and the distal ends of the free sections are almost flat. The closer the two diaphragms are to the distal end of the free section 22 in the axial direction, the more they tend to form a planar membrane structure that fits each other, so as to form a lateral opening 221 at the distal end of the funnel-shaped structure that is closed in a natural state without external interference. The funnel-shaped structure includes a wide portion 203 and a narrow portion 204, wherein the wide portion 203 is the connecting section 21, and the narrow portion 204 is the free section 22. The wide portion 203 includes a large end 203a away from the narrow portion 204, and the narrow portion 204 includes a small end 204a away from the wide portion 203, and the large end 203a is circumferentially connected to the stent graft 10. In this embodiment, the connecting section 21 connects the entire one-way valve component 20 to the stent graft 10 through the large end 203a, and the free section 22 is suspended in the stent graft 10 because it is the narrow portion 204, and the connecting section 21 and the free section 22 are an integral structure. In other embodiments, the distal end of the free section 22 may also extend beyond the distal end of the stent graft 10, and there is no limitation on this.

[0042] The one-way valve component 20 includes a first diaphragm 201 and a second diaphragm 202. The first diaphragm 201 and the second diaphragm 202 can be planar diaphragms arranged opposite to each other, and the two axial edges of the first diaphragm 201 are respectively attached to the two axial edges of the second diaphragm 202. The adjacent axial edges can be sutured with sutures, and the openings at the proximal and distal ends are not sutured. After the first diaphragm 201 and the second diaphragm 202 are attached to each other, the transversely wider end of the diaphragm is sutured circumferentially to the proximal inner side of the stent graft 10 to form a funnel-shaped one-way valve component 20, so that the proximal end of the connecting section 21 is sutured circumferentially to the proximal port of the stent graft 10, as shown in FIG. Figure 6 Combination Figure 5 The free section 22 may be in the shape of a long strip at one end close to the connecting section 21. When the adjacent edges of the first diaphragm 201 and the second diaphragm 202 at the connecting section 21 are connected, a first connecting line 2012 and a second connecting line 2021 are formed. Figure 5 Combination Figure 3-4As shown, when the proximal end of the connecting segment 21 of the one-way valve component 20 is connected to the coated stent 10, the first connecting line 2012 and the second connecting line 2021 intersect with the coated stent 10 at the first connecting point 2012a and the second connecting point 2021a respectively, and the first connecting point 2012a and the second connecting point 2021a form a connecting line. Generally, when the connecting segment 21 and the free segment 22 are an integral structure, or a single diaphragm is cut and formed as a whole from the proximal end to the distal end, the extension direction of the connecting line is consistent with the extension direction of the transverse opening 221.

[0043] The diaphragms of the free section 22 gradually come closer from the proximal end to the distal end, thereby forming a transverse opening 221 at the distal end of the free section 22. In the natural state, the two diaphragms fit each other at the transverse opening 221 at the distal end of the free section 22, and the transverse opening 221 is in a closed state. When the sheath core component 91 needs to pass through, the transverse opening 221 can be opened with the help of external force to allow the sheath core component 91 to pass through.

[0044] That is, the one-way valve component 20 blocks the inner cavity of the coated stent 10, and only leaves the transverse opening 221 at the distal end of the free segment 22 for the sheath core assembly 91 to pass through. When the liquid flows from the proximal end to the distal end of the one-way valve component 20 (the large opening 203a flows to the small opening 204a), the liquid can flow out through the transverse opening 221 at the distal end of the free segment 22, and does not completely block the blood flow; when the liquid flows from the distal end to the proximal end (the small opening 204a flows to the large opening 203a) of the one-way valve component 20, after the delivery device 90 is withdrawn, the distal port 211 of the free segment 22 gradually approaches from the proximal end to the distal end, and the diaphragm tends to be parallel and mutually fitted planes, and the reverse flow of the liquid is not smooth, thereby realizing the one-way blocking function. During the release process of using the delivery device 90 to deliver the occluding stent 100 into the false cavity, since the sheath-core assembly 91 penetrates from the distal end of the one-way valve component 20 and passes out from the proximal end of the one-way valve component 20, the distal end of the one-way valve component 20 is in an open state; after the occluding stent 100 is completely released, the sheath-core assembly 91 is withdrawn from the occluding stent 100, and when there is no external force, the transverse opening 221 will be in a closed state.

[0045] The occluding stent 100 with the one-way valve component 20 can be implanted in the false lumen to achieve one-way closure of the false lumen channel, so as to block the channel for blood flow reflux, thereby preventing blood from flowing back into the false lumen. Figure 7-8 Combination Figure 3 shown.

[0046] Taking the thoracic aorta as an example, the distal end of the occluding stent 100 is placed flush or nearly flush with the distal end of the thoracic main stent 1010. A developing piece can be set at the distal end of the occluding stent 100 to compare with the developing piece at the distal end of the thoracic main stent to achieve flush implantation of the distal ends of the two stents. When the occluding stent 100 with the one-way valve component 20 is delivered to the false cavity to achieve one-way closure of the false cavity channel, since the occluding stent 100 generally needs to cooperate with the thoracic main stent implanted in the aortic cavity, the occluding stent 100 is squeezed by the thoracic main stent 1010. Since the connecting section 21 of the one-way valve component 20 is connected to the coated stent 10, and the free section 22 is suspended, when the occluding stent 100 is squeezed by the thoracic main stent and the outer wall 1003c of the blood vessel, the thoracic main stent applies a radial squeezing force F to the occluding stent 100, and the outer wall 1003c of the blood vessel applies a radial squeezing force F' to the occluding stent 100 (the directions of the squeezing forces F and F' are opposite, such as Fig.10 As shown in FIG. 1 , the wide portion 203 of the connecting section 21 is also squeezed in this direction. When the direction of the squeezing force is consistent with the direction of the line L5 formed by the two connecting points and the extending direction of the transverse opening 221 (the angle between the two is 0) or tends to be consistent, it is easy to cause the transverse opening 221 at the distal end of the suspended free section 22 to open and leak blood in the reverse direction, such as Fig.10 As shown. The trend to be consistent means that the angle between the straight line where the radial extrusion force F on the occluding stent 100 is located and the direction of the line L5 connecting the two connection points is between (0, 45°]. The specific reasons are as follows:

[0047] When the occluding stent 100 is subjected to radial extrusion force from the main chest stent in the direction of the line L5 formed by the two connection points of the diaphragm and the occluding stent 100, the occluding stent 100 will be deformed. This is because when the suture positions where the axial edges of the two diaphragms of the one-way valve component 20 are connected to each other are squeezed, it is easy for the connecting section 21 to form a bulge in the axial direction toward the outside of the one-way valve component 20. The bulge extends axially to form a tendency to bulge toward the outside of the one-way valve component 20. When it extends to the free section 22, it will cause the two diaphragms of the free section 22 to change from a fitted state to a state of being separated from each other. That is, when the connecting section 21 is subjected to radial extrusion and deformation in the direction of the main chest stent, the two diaphragm parts at the position of the free section 22 will be separated from each other, so that the transverse opening 221 is in an open state, as shown in FIG. Fig.10 shown.

[0048] In order to prevent the occluding stent from being squeezed by the main thoracic stent, causing the lateral opening at the distal end of the free segment to be in an open state, the one-way valve component 20 also includes a self-restoring structure 30 provided on the free segment 22. The end of the self-restoring structure 30 away from the connecting segment includes a curling portion 32. The curling portion 32 has a shape memory function, so that it bends naturally in a natural state and can be straightened under the action of external force. In the embodiment, the curling portion 32 is directly provided, and there is no need to distinguish the circumferential position of the occluding stent 100 relative to the main thoracic stent, and the complexity of the operation is not increased. When the occluding stent 100 is released in the false cavity, the stability of the closed state of the lateral opening 221 at the distal end of the free segment 22 can still be maintained, and the occluding effect is better, which avoids the continuous expansion or even rupture of the false cavity.

[0049] like Figure 11-15 As shown, the self-restoring structure 30 includes an axial support portion 31, and the curling portion is connected to the end of the axial support portion away from the connecting section. In this embodiment, the self-restoring structure 30 includes an elastic wire, and the elastic wire includes an axial support portion 31 connected to a curling portion 32. The number of axial support portions is at least one, and two or more axial support portions may also be provided. In this embodiment, two elastic wires are arranged opposite to each other along the axial direction. The self-restoring structure 30 includes an axial support portion 31 and a curling portion 32, that is, the elastic wire includes an axial support portion 31 and a curling portion 32. One end of the curling portion 32 is connected to the distal end of the axial support portion 31, and the other end of the curling portion 32 is bent and then extended. The curling portion 32 includes a bent section 32a and an extended section 32b, and the bent section 32a connects the axial support portion 31 and the extended section 32b, and the self-restoring structure 30 is sutured as a whole to the diaphragm of the free section 22. In this embodiment, the free sections 22 of the two membranes are attached to each other, the self-restoring structure 30 is sewn to the outside of one of the membranes, and the curling portion 32 is curled toward the other membrane, such as Fig.13 shown.

[0050] In this embodiment, if Fig.14 As shown, the angle of the central angle γ corresponding to the bending of the curved section 32a is greater than 90°, so that the curling portion 32 of the self-restoring structure 30 can drive the corresponding diaphragm to curl, ensuring the curling effect of the curling portion 32 on the distal transverse opening 221 of the free section 22, as shown in FIG. Fig.13 shown.

[0051] The extension direction of the extension section 32b can extend along the tangent direction of the end of the curved section 32a away from the axial support portion 31, or can continue to bend and extend along the bending direction of the curved section 32a toward the axial support portion 31, which is not limited here. Figure 13-14 As shown, the wire diameter of the extension section 32b is smaller than the wire diameter of the bend section 32a. The bend section 32a enables the self-recovering structure 30 to form a self-curling shape at the distal end of the free section 22. The curling portion 32 naturally curls the distal end of the free section 22 to block the transverse opening 221, thereby improving the blocking effect and promoting embolization of the false cavity. Fig.15 The sheath core 91a is shown passing through the one-way valve component 20 so that the naturally curled self-restoring structure 30 is Figure 12-13 The natural state (curled state) unfolds to Fig.15 In the non-natural state of axial expansion, when the occluding stent 100 is successfully released, the sheath core 91a is withdrawn from the lateral opening 221 of the one-way valve component 20, and the distal end of the one-way valve component 20 is curled and sealed under the self-restoring action of the self-restoring structure 30. The design of the self-restoring curling can increase the reliability of the closure without increasing the complexity and time of the surgical operation.

[0052] The material of the self-restoring structure 30 can be elastic materials such as nickel-titanium alloy and polymer fiber. In the present embodiment, the self-restoring structure 30 is a shape memory material such as nickel-titanium alloy wire, and also includes a limit portion 33, which is arranged at the proximal end of the axial support portion 31, and is bent along the axial support portion 31 on the plane of the free section 22 to form a ring shape. The self-restoring structure 30 is generally fixed to the diaphragm by binding wire, and is fixed to the diaphragm of the free section 22 in the form of a knot at the tail end of the binding wire. The proximal end of the self-restoring structure 30 is in a ring shape, which can ensure the connection strength between the nickel-titanium alloy wire and the diaphragm, increase the connection stability between the nickel-titanium alloy wire and the diaphragm, and ensure that the nickel-titanium alloy wire does not slide out of the binding wire along the axial direction; it can also reduce the possibility of the nickel-titanium alloy wire puncturing the diaphragm.

[0053] In this embodiment, the wire diameter of the axial support portion 31 ranges from 0.3 mm to 0.45 mm. The wire diameter of the extension section 32b gradually decreases from one end close to the curved section 32a to the direction away from the curved section 32a. The extension section 32b can be polished and refined into a cone shape by nickel-titanium alloy wire, so that the curling force of the tail end of the self-restoring structure 30 is reduced when the sheath core 91a is withdrawn, making it easier to withdraw the sheath core 91a.

[0054] In other embodiments, Figure 16-17As shown, the self-restoring structure 40 includes an axial support portion 41, a curled portion 42 and a limit portion 43, and the number of the axial support portions 41 is at least two. The self-restoring structure 40 also includes a transverse support portion 44, and the transverse support portion 44 includes a curled waveform unit connected between two adjacent axial support portions 41. The portion of the waveform unit parallel to the axial support portion 41 is the transverse support portion 44 of the self-restoring structure, and the curled portion of the waveform unit is the curled portion 42. The two transverse ends of the waveform structure are respectively connected to the distal ends of the two elastic wires, and the waveform structure has the same bending trend as the curved section 32a in the axial direction. The waveform structure can extend 2-4 wave cycles in the transverse direction. The lateral support portion 44 can be against the sheath core when the sheath core passes through the one-way valve component 20, so that the sheath core has a supporting force on the distal end of the self-restoring structure 40, so that when the sheath core passes through the one-way valve component 20, the distal end of the self-restoring structure 40 is axially straightened under the support of the sheath core; when the sheath core is withdrawn from the occluding stent 100, the self-restoring structure 40 returns to its natural state, so that the curling portion 42 of the self-restoring structure 40 can drive the diaphragm at the corresponding position to curl, thereby ensuring the curling effect of the curling portion 42 on the lateral opening 221 at the distal end of the free section 22.

[0055] In other embodiments, Figure 18-19 As shown, the self-restoring structure 50 includes an axial support portion 51 and a curling portion 52, and the curling portion 52 is connected to the distal end of the axial support portion 51. The axial support portion of the self-restoring structure 50 is a mesh structure, and the self-elastic metal wire forming the mesh can be a nickel-titanium alloy wire, and the wire diameter range can be 0.08mm to 0.25mm. Within this range of wire diameter, it can prevent the problem that the self-restoring elasticity of the curling portion is small due to the wire diameter being too small, which is insufficient to drive the diaphragm to curl; it can also prevent the wire diameter from being too large, and when it is against the sheath core, the curling force is too large, affecting the withdrawal of the sheath core. Figure 18-19 As shown, in this embodiment, the wire diameter is 0.1 mm. The self-restoring structure 50 may include a curled mesh structure, or may include two curled mesh structures. When the self-restoring structure 50 includes a curled mesh structure, the mesh structure of the self-restoring structure 50 is attached to the outside of one of the diaphragms and is sutured and fixed to the diaphragm. The distal end of the mesh structure is bent to form a curled portion 52. In a natural state, the mesh structure curls with the distal end of the free section 22, so that the distal end of the free section 22 achieves a curling effect, so that the transverse opening 221 is sealed.

[0056] In other embodiments, Figure 20-25As shown, when the self-restoring structure 60 includes two curled mesh structures, the self-restoring structure 60 includes a first curling structure 601 and a second curling structure 602. The first curling structure 601 includes a connected axial support portion 61 and a curling portion 62. The first curling structure 601 extends along the free section 22. The first curling structure 601 is integrally attached to the outside of one of the diaphragms and is sutured and fixed to the diaphragm. The curling direction of the curling portion 62 of the first curling structure 601 is toward the direction of the other diaphragm, thereby driving the distal end of the free section 22 of the diaphragm to curl toward the direction. The second curling structure 602 includes a connected support section 6021 and a curling covering section 6022; the proximal end of the support section 6021 is connected to the other diaphragm on the other side of the free section 22, and the proximal end of the second curling structure 602 is flush or nearly flush with the proximal end of the first curling structure 601 (almost flush means that the length of one side axially exceeding the other side does not exceed 2mm). The distal end of the support segment 6021 is connected to the end of the curled covering segment 6022 close to the connecting segment. Except for the proximal end of the support segment 6021 connected to the free segment 22, the support segment 6021 is suspended in the stent graft; the curled covering segment 6022 is curled in a natural state and covers the outer side (distal end) of the curled portion 62, such as Figure 20-21 As shown, the curling direction of the curled covering segment 6022 is opposite to the curling direction of the curled portion 62, so that when the self-restoring structure 60 is in a natural state (when the self-restoring structure 60 is not subjected to external force, in the present invention, the sheath core is withdrawn from the occluding stent 100, and the free segment 22 of the one-way valve component is not resisted by the sheath core), as shown in FIG. Figure 20-21 As shown, the curled covering section 6022 is wrapped around the distal side of the curled portion 62 .

[0057] like Figure 22-25 As shown, it shows the process of the delivery device delivering the occluding stent 100 to the false cavity 1002 and releasing the occluding stent 100 in the false cavity 1002. Fig. 22 As shown, at this time, the occluding stent 100 is loaded in the conveying device, and the conveying device loaded with the occluding stent 100 (conveying system) conveys the occluding stent 100 to the place to be released in the false cavity 1002; Figure 23-24 As shown, the self-restoring structure 60 of the one-way valve component is in an unnatural state of axial expansion due to the sheath core component passing through the one-way valve component. In this unnatural state, the distal end of the curled cover section 6022 along the axial expansion exceeds the distal end of the curled portion 62 along the axial expansion, so that when the sheath core component passes through the one-way valve component, the distal end of the second curled structure 602 exceeds the distal end of the first curled structure 601. The occluding stent 100 is gradually released as the sheath tube is withdrawn. Fig.23 The middle is a schematic diagram of the state in which the sheath tube 92 is withdrawn until the stent graft 10 is expanded and released; Fig.24 The sheath tube 92 is retracted to the distal end of the stent graft 10 so that the coating of the stent graft is completely released, but the sheath core has not yet been released.

[0058] After the sheath is withdrawn to release the coated distal end of the stent, the stent has been released from the wall. If a rear release structure is set at the proximal end of the stent, the sheath core assembly is controlled to complete the rear release of the proximal bare wave ring (not shown). If no rear release structure is set, the sheath core can be further withdrawn to allow the sheath core to withdraw from the one-way valve component.

[0059] like Fig.25 As shown in FIG. 2 , during the process of the sheath core 91a being withdrawn from the one-way valve component along the axial direction, the tip head 911 first loses the abutting relationship with the first curled structure 601, and the curled portion 62 of the first curled structure 601 first drives the distal end of the free section 22 to curl, thereby blocking the transverse opening 221; the sheath core is further withdrawn, and the abutting relationship between the distal end of the second curled structure 602 and the tip head 911 disappears, and the curled covering section 6022 of the second curled structure 602 naturally returns to the curled state, thereby covering the outer side of the curled curled portion 62, as shown in FIG. Fig.21 As shown (the natural curling state of the self-healing structure 60 ), the blocking effect can be improved and the embolization of the false cavity 1002 can be promoted.

[0060] This embodiment also includes a blocking system, such as Figure 26-27 As shown, the embodiment includes a delivery device 90 and the above-mentioned occluding stent 100 in this embodiment, the delivery device 90 includes a sheath core component 91 and a sheath tube 92, and the distal end of the one-way valve component 20 is in an open state (combined with Figure 11-20 and Figure 23-24 As shown in the figure, the sheath core assembly 91 is inserted into the distal end of the one-way valve component 20 and passes out from the proximal end of the one-way valve component 20. The sheath core assembly 91 includes a sheath core 91a and a tip head 911 provided at the proximal end of the sheath core 91a for guiding the delivery. The sheath core assembly 91 may also include a rear release structure, and a bare wave ring is correspondingly provided at the proximal end of the occluding stent 100, which cooperates with the rear release structure to realize the rear release of the proximal end of the occluding stent.

[0061] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0062] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A blocking stent, characterized in that: The occluding stent includes a coated stent and a one-way valve component, the one-way valve component is arranged in the hollow cavity of the coated stent and / or its extended cavity, the one-way valve component includes a connected connecting segment and a free segment, the end of the connecting segment away from the free segment is circumferentially connected to the coated stent, the occluding stent also includes a self-restoring structure arranged on the free segment, the end of the self-restoring structure away from the connecting segment includes a curled portion, and the curled portion has a shape memory function.

2. The occluding stent according to claim 1, characterized in that: The self-restoring structure includes an axial support portion, and the curled portion is connected to an end of the axial support portion away from the connecting section.

3. The occluding stent according to claim 2, characterized in that: The self-restoring structure includes an elastic wire, which includes an axial support portion connected to the curled portion, the curled portion includes a bent section and an extended section, the bent section connects the axial support portion and the extended section, and the wire diameter of the extended section is smaller than the wire diameter of the bent section.

4. The occluding stent according to claim 2, characterized in that: The wire diameter of the extension section gradually decreases from one end close to the bend section to a direction away from the bend section.

5. The occluding stent according to claim 2, characterized in that: The number of the axial support parts is at least one, and the self-restoring structure also includes a curled corrugated unit connected to the axial support part, the part of the corrugated unit parallel to the axial support part is the lateral support part of the self-restoring structure, and the curled part of the corrugated unit is the curled part.

6. The occluding stent according to claim 2, characterized in that: The axial support portion of the self-restoring structure is a mesh structure.

7. The occluding stent according to claim 2, characterized in that: The self-restoring structure includes a first curling structure and a second curling structure, the first curling structure includes a connected axial support portion and a curling portion, the first curling structure extends along the free section and is arranged on one side of the free section; the second curling structure includes a connected support section and the curling covering section, the proximal end of the support section is connected to the other side of the free section, the distal end of the support section is connected to the end of the curling covering section close to the connecting section, the curling direction of the curling covering section is opposite to the curling direction of the curling portion, so that when the self-restoring structure is in a natural state, the curling covering section is covered on the distal side of the curling portion.

8. The occluding stent according to claim 7, characterized in that: The distal end of the curled cover section along the axial direction is beyond the distal end of the curled portion along the axial direction.

9. The occluding stent according to claim 1, characterized in that: The one-way valve component includes at least two membrane sheets, and the adjacent edges of at least two of the membrane sheets are connected to each other to form a funnel-shaped structure; the funnel-shaped structure includes a wide portion and a narrow portion, the wide portion is a connecting section, and the narrow portion is a free section, the wide portion includes a large mouth end away from the narrow portion, and the large mouth end is circumferentially connected to the coated stent.

10. A blocking system, characterized in that: It comprises a delivery device and an occluding stent as described in any one of claims 1 to 10, wherein the delivery device comprises a sheath-core assembly and a sheath tube, and the distal end of the one-way valve component is in an open state, allowing the sheath-core assembly to penetrate from the distal end of the one-way valve component and pass out from the proximal end of the one-way valve component.

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