Blocking stent and blocking system

Abstract

The application relates to a closure stent and a closure system, the closure stent comprising a covered stent and a one-way valve member, the one-way valve member being arranged in a hollow cavity or / and an extension cavity of the covered stent, the one-way valve member comprising a connected section and a free section, the connected section being connected to the covered stent in a circumferential direction away from one end of the free section, and the closure stent further comprising a self-recovery structure arranged on the free section, the self-recovery structure comprising a curling part away from an end part of the connected section, and the curling part having a shape memory function. The closure stent provided by the application has the design of the self-recovery curling edge, can increase the closing reliability, and can make the closure effect better without increasing the complexity of the operation and the operation time.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a stent and occlusion system for occluding aortic dissection in a false lumen. Background Technology

[0002] Aortic dissection (AD) occurs when blood from within the aortic lumen enters the aortic media (1003b) through a tear in the aortic intima (1003a), causing the media (1003b) to separate from the intima (1003a) and the outer wall (1003c). (Reference) Figure 8 Aortic dissection (as indicated by the number 1001) is a pathological change that extends along the long axis of the aorta, forming the true lumen 1001 and the false lumen 1002. Currently, thoracic endovascular aortic repair (TEVAR) has become the most commonly used surgical procedure for treating aortic dissection in clinical practice due to its low mortality and morbidity rates.

[0003] However, after TEVAR, factors such as the pressure difference between the true and false lumens, vascular morphology, and the physical properties of the implanted stent can lead to stent-induced new entry (SINE). In 20%-30% of patients after TEVAR, the false lumen will develop SINE at the distal end of the stent, and blood will flow back through the distal SINE. Figure 1 (As indicated by the arrow) Entering the false cavity 1002 causes the false cavity to continuously expand or even rupture, such as... Figure 1 As shown. Summary of the Invention

[0004] One technical problem solved by this invention is how to provide a stent with good occlusion effect to prevent blood backflow without increasing the complexity of the procedure.

[0005] The present invention provides an occlusion stent, the occlusion stent comprising a covered stent and a one-way valve component, the one-way valve component being disposed in the hollow cavity and / or its extension cavity of the covered stent, the one-way valve component comprising a connected connecting segment and a free segment, the end of the connecting segment away from the free segment being circumferentially connected to the covered stent, the occlusion stent further comprising a self-recovering structure disposed in the free segment, the end of the self-recovering structure away from the connecting segment comprising a curled portion, the curled portion having shape memory function.

[0006] One technical effect of one embodiment of the present invention is that by setting a self-recovering structure, the distal end of the one-way valve component is rolled up and sealed under the self-recovering action of the self-recovering structure. The self-recovering rolled edge design can increase the reliability of closure, and at the same time, improve the sealing effect without increasing the complexity of surgical operation and surgical time.

[0007] On the other hand, the present invention also provides an occlusion system, including a delivery device and an occlusion support as described above. The delivery device includes a sheath core assembly and a sheath tube. The distal end of the one-way valve member is open, allowing the sheath core assembly to pass through the distal end of the one-way valve member and exit from the proximal end of the one-way valve member. Attached Figure Description

[0008] Figure 1 This is a schematic diagram illustrating the impact of blood backflow on the false cavity due to the distal rupture in the background art.

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

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

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

[0012] Figure 5 This is a three-dimensional structural diagram of the unidirectional valve component provided by the present invention;

[0013] Figure 6 A schematic diagram showing the unfolding of the two diaphragms constituting the unidirectional valve component provided by the present invention when they are not fixed to the covered support;

[0014] Figure 7 This is a schematic diagram illustrating the implantation of a stent in a false lumen to prevent blood backflow within the false lumen, as provided by the present invention.

[0015] Figure 8 A top view of the occlusion stent provided by the present invention when matched with the main chest stent (with) Figure 7 (For reference from a direct perspective);

[0016] Figure 9 This is a schematic diagram showing the extension direction of line L5 when the occlusion stent provided by the present invention expands naturally from a top-down view, without being implanted in the false cavity.

[0017] Figure 10 This is a schematic diagram from a top view when the direction of the radial compressive force F (F') of the occlusion stent provided by the present invention is consistent with the direction of the connecting line L5;

[0018] Figure 11 This is a three-dimensional structural diagram of the occlusion stent provided by the present invention (showing the unidirectional valve component);

[0019] Figure 12 This is a schematic diagram of the unidirectional valve component and self-recovering structure provided by the present invention;

[0020] Figure 13 This is a side view of the unidirectional valve component and self-recovering structure provided by the present invention.

[0021] Figure 14 This is a side view of the self-recovering structure provided by the present invention;

[0022] Figure 15 A side view of the unidirectional valve component of the occlusion stent provided by the present invention, through which the sheath core passes;

[0023] Figure 16 This is a schematic diagram illustrating other embodiments of the self-recovering structure and unidirectional valve component provided by the present invention in their natural state;

[0024] Figure 17 for Figure 16 An enlarged view of the self-recovering structure in its natural state;

[0025] Figure 18 Schematic diagrams illustrating other embodiments of the self-recovering structure (mesh structure) provided by the present invention in its natural state;

[0026] Figure 19 for Figure 18 A schematic diagram of the self-recovering structure and other embodiments of the unidirectional valve component in its natural state;

[0027] Figure 20 The self-recovering structure provided by the present invention includes two curled mesh structures (the first curled structure is not shown), which is a schematic diagram of the unidirectional valve component in its natural state.

[0028] Figure 21 The self-recovering structure provided by the present invention includes two curled mesh structures, and is shown in the side view of the unidirectional valve component in its natural state.

[0029] Figure 22 The diagram shows the occlusion stent provided by the present invention being loaded into a conveying device, which carries the occlusion stent (conveyor system) and transports the occlusion stent to the release point in the false cavity;

[0030] Figure 23 The self-recovering structure provided by the present invention includes two coiled mesh structures as the occlusion stent, which is retracted to the covered stent after the sheath tube is withdrawn, and the covered stent is partially released and expanded (the self-recovering structure of the one-way valve component is in an unnatural state of axial expansion due to the sheath core assembly passing through the one-way valve component).

[0031] Figure 24The self-recovering structure provided by the present invention includes two coiled mesh structures for occlusion, with the sheath retracted to the distal end of the covered stent (the self-recovering structure of the unidirectional valve component is in an unnatural state of axial expansion due to the sheath core assembly passing through the unidirectional valve component).

[0032] Figure 25 The self-recovering structure provided by the present invention includes two coiled mesh structures for occlusion stents, and a schematic diagram of the tip of the sheath core assembly being withdrawn from the one-way valve component;

[0033] Figure 26 This is a schematic diagram of the conveying system provided by the present invention;

[0034] Figure 27 This is a schematic diagram of the delivery system provided by the present invention releasing the sealing support into the false cavity. Detailed Implementation

[0035] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the invention.

[0036] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0037] "Axial" generally refers to the length direction of a medical device during delivery; "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction and passing through the center of the lumen; and "lateral" generally refers to the direction of the medical device perpendicular to its "axial" direction. Based on this principle, the "axial," "radial," and "lateral" directions of any component of a medical device are defined. Furthermore, when describing luminal stents or covered stents in a true lumen, the orientation can be defined according to the direction of blood flow in the blood vessel. In this invention, 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 rupture described in this invention is at the distal end of the main thoracic stent, the direction of blood flow from the distal rupture into the false lumen is defined as from the distal end of the occluding stent towards its proximal end. Due to the blocking effect of the occluding stent, the blood flow from the distal rupture into the false lumen impacts the distal end of the one-way valve component.

[0038] This invention provides an occlusion stent 100 and an occlusion system, such as Figure 2-27As shown, the occlusion stent 100 includes a covered stent 10 and a one-way valve component 20. It can be implanted in the false lumen caused by type B aortic dissection to prevent blood from flowing back into the false lumen due to tearing of the distal end of the false lumen, which could lead to continuous expansion or even rupture of the false lumen. It can also be used in other vascular cavities that require occlusion to prevent blood backflow.

[0039] like Figure 2-4 As shown, the covered stent 10 is a tubular structure with openings at both ends. The covered stent 10 includes a main wave coil 11 and a covering 12. The covering 12 is disposed on the main wave coil 11. Multiple main wave coils 11 are arranged axially and connected by the tubular covering 12. Two to fourteen main wave coils can be provided. The axial length of the covered stent 10 ranges from 30mm to 140mm. In this embodiment, taking the occlusion of a false lumen caused by aortic dissection caused by the implantation of the stent 100 as an example, the main wave coil 11 can be disposed on the outer side of the covering 12. During implantation, this increases the friction between the stent and the inner wall of the false lumen, which helps prevent the occlusion stent 100 from shifting or shortening relative to the inner wall of the false lumen. In other embodiments, the main wave coil 11 can also be disposed on the inner side of the covering 12, or partially disposed on the inner side and partially disposed on the outer side of the covering 12; no limitation is made 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 covered stent 10. The one-way valve component 20 is disposed in the hollow cavity of the covered stent 10 and / or its extended cavity. The extended cavity refers to the cavity formed by extending axially along the end of the covered stent 12. That is, except for the part of the one-way valve component 20 at the proximal connection position of the connecting segment 21, the other part can be disposed in the hollow cavity of the covered stent 10 or extend beyond the distal end of the covered stent 12.

[0041] like Figure 3-6 As shown, the one-way valve assembly 20 includes at least two diaphragms, with adjacent edges of the at least two diaphragms connected to each other to form a funnel-shaped structure; when not sutured to the covered stent 10, the diaphragms have a planar structure, as shown... Figure 6 As shown, the two membranes have the same shape, and the two membranes can be a single integrated structure (e.g., Figure 6The two membranes shown are connected by a connection point, or they can be separate structures (two completely separate membranes), which is not limited here. After the axial edges of the two planar membranes are sewn together, the two membranes are attached to each other. Then, the large end of the connecting segment is opened into a ring and sewn to the inner side of the proximal end of the membrane support, so that the adjacent edges of the two membranes are connected to each other to form an axisymmetric structure of a funnel shape. At this time, from the large end of the connecting segment to the small end, the two membranes gradually approach each other, and the distal ends of the free segments are almost flat and attached. The closer the two membranes are to the distal end of the free segment 22 in the axial direction, the more they tend to be flat and attached to each other, so that the transverse opening 221 at the distal end of the funnel shape is closed in the natural state without external force interference. The funnel-shaped structure includes a wide portion 203 and a narrow portion 204. The wide portion 203 is the connecting segment 21, and the narrow portion 204 is the free segment 22. The wide portion 203 includes a large opening 203a away from the narrow portion 204, and the narrow portion 204 includes a small opening 204a away from the wide portion 203. The large opening 203a is circumferentially connected to the covered stent 10. In this embodiment, the connecting segment 21 connects the entire unidirectional valve component 20 to the covered stent 10 through the large opening 203a. The free segment 22, being the narrow portion 204, is suspended within the covered stent 10. The connecting segment 21 and the free segment 22 are an integral structure. In other embodiments, the distal end of the free segment 22 may extend beyond the distal end of the covered stent 10; this is not limited.

[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 each other. The two axial edges of the first diaphragm 201 are respectively abutted against the two axial edges of the second diaphragm 202. Their adjacent axial edges can be sutured together, and the proximal and distal openings are not sutured. After the first diaphragm 201 and the second diaphragm 202 are abutted together, the wider end of the diaphragm is sutured circumferentially to the proximal inner side of the covered stent 10, forming a funnel-shaped one-way valve component 20. This allows the proximal end of the connecting segment 21 to be circumferentially sutured to the proximal port of the covered stent 10. Figure 6 Combination Figure 5 As shown. The end of the free segment 22 near the connecting segment 21 can be elongated. When the adjacent edges of the first diaphragm 201 and the second diaphragm 202 at the connecting segment 21 are connected, a first connecting line 2012 and a second connecting line 2021 are formed, as shown. 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 covered stent 10, the first connecting line 2012 and the second connecting line 2021 intersect the covered stent 10 at the first connecting point 2012a and the second connecting point 2021a, respectively. The first connecting point 2012a and the second connecting point 2021a form a line. Generally, when the connecting segment 21 and the free segment 22 are an integral structure, or in other words, a single diaphragm is integrally cut 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 segment 22 gradually come together from the proximal end to the distal end, thereby forming a transverse opening 221 at the distal end of the free segment 22. In the natural state, the two diaphragms are attached to each other and the transverse opening 221 is in a closed state. When the sheath core assembly 91 needs to pass through, the transverse opening 221 can be opened with the help of external force to allow the sheath core assembly 91 to pass through.

[0044] That is, the one-way valve component 20 blocks the inner lumen of the covered stent 10, leaving only the transverse opening 221 at the distal end of the free segment 22 for the sheath core assembly 91 to pass through. When the fluid flows from the proximal end to the distal end of the one-way valve component 20 (from the large opening 203a to the small opening 204a), the fluid can flow out through the transverse opening 221 at the distal end of the free segment 22, without completely obstructing blood flow. When the fluid flows from the distal end to the proximal end of the one-way valve component 20 (from the small opening 204a to the large opening 203a), 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 attached to the plane, so the reverse flow of fluid is not smooth, thereby achieving the one-way occlusion function. During the release process of delivering the occlusion stent 100 into the false lumen using the delivery device 90, the sheath core assembly 91 enters from the distal end of the one-way valve component 20 and exits from the proximal end of the one-way valve component 20, resulting in an open distal end of the one-way valve component 20. After the occlusion stent 100 is fully released, the sheath core assembly 91 is withdrawn from the occlusion stent 100, and the transverse opening 221 will be closed under the influence of no external force.

[0045] An occlusion stent 100 with a one-way valve component 20 can be implanted into a false lumen to achieve one-way closure of the false lumen channel, thereby blocking the pathway for blood backflow and preventing blood from flowing back into the false lumen. Figure 7-8 Combination Figure 3 As shown.

[0046] Taking the thoracic aorta as an example, the distal end of the occlusion stent 100 is placed flush with or nearly flush with the distal end of the thoracic main stent 1010. A contrast-enhancing element can be placed at the distal end of the occlusion stent 100 to correspond with the contrast-enhancing element at the distal end of the thoracic main stent, achieving flush implantation of the two stents. When the occlusion stent 100 with the one-way valve component 20 is delivered into the false lumen to achieve one-way closure of the false lumen channel, the occlusion stent 100 generally needs to cooperate with the thoracic main stent implanted in the aortic lumen. The occlusion stent 100 is compressed by the thoracic main stent 1010. Because the connecting segment 21 of the one-way valve component 20 is connected to the covered stent 10, and the free segment 22 is suspended, when the occlusion stent 100 is compressed by the thoracic main stent and the vessel wall 1003c, the thoracic main stent applies a radial compressive force F to the occlusion stent 100, and the vessel wall 1003c applies a radial compressive force F' to the occlusion stent 100 (the compressive forces F and F' are in opposite directions, such as...). Figure 10 As shown), the wide portion 203 of the connecting segment 21 is also compressed in this direction. When the direction of this compressive force is consistent with or tends to be consistent with the direction of the line L5 connecting the two connection points and the extension direction of the transverse opening 221 (the angle between the two is 0), it is easy to cause the transverse opening 221 at the distal end of the suspended free segment 22 to open and leak blood in the reverse direction. Figure 10 As shown. The tendency towards consistency means that the angle between the straight line containing the direction of the radial compressive force F on the sealing bracket 100 and the line L5 connecting the two connection points is within the range of (0, 45°). The specific reasons are as follows:

[0047] When the occlusion stent 100 is subjected to radial compressive force from the main thoracic stent along the line L5 connecting the two connection points of the diaphragm and the occlusion stent 100, the occlusion stent 100 will deform. This is because when the sutures connecting the axial edges of the two diaphragms of the one-way valve component 20 are compressed, the connecting segment 21 is prone to bulging outward along the axial direction towards the outside of the one-way valve component 20. This bulge extends axially towards the outside of the one-way valve component 20. When it extends to the free segment 22, it causes the two diaphragms of the free segment 22 to change from an adhered state to a state of separation. That is, when the connecting segment 21 is deformed by radial compression in the direction of the main thoracic stent, the two diaphragm portions at the position of the free segment 22 will move away from each other, causing the transverse opening 221 to be in an open state. Figure 10 As shown.

[0048] To prevent the occlusion stent from being compressed by the main thoracic stent, causing the transverse opening at the distal end of the free segment to become open, the one-way valve component 20 also includes a self-recovering structure 30 located on the free segment 22. The end of the self-recovering structure 30 away from the connecting segment includes a curled portion 32. The curled portion 32 has shape memory function, allowing it to bend naturally in its natural state and straighten under external force. In this embodiment, the curled portion 32 is directly provided, eliminating the need to distinguish the circumferential orientation of the occlusion stent 100 relative to the main thoracic stent, and without increasing the complexity of the surgery. It still maintains the stability of the closed state of the transverse opening 221 at the distal end of the free segment 22 when the occlusion stent 100 is released into the false lumen, resulting in better occlusion and preventing continuous expansion or even rupture of the false lumen.

[0049] like Figure 11-15 As shown, the self-recovering structure 30 includes an axial support portion 31, and a coiled portion is connected to the end of the axial support portion away from the connecting section. In this embodiment, the self-recovering structure 30 includes an elastic filament, which includes an axial support portion 31 connected to the coiled portion 32. At least one axial support portion is provided, and two or more may be provided. In this embodiment, two elastic filaments are arranged opposite each other along the axial direction. The self-recovering structure 30 includes an axial support portion 31 and a coiled portion 32, i.e., the elastic filament includes an axial support portion 31 and a coiled portion 32. One end of the coiled portion 32 is connected to the distal end of the axial support portion 31, and the other end of the coiled portion 32 extends after bending. The coiled portion 32 includes a bent section 32a and an extended section 32b. The bent section 32a connects the axial support portion 31 and the extended section 32b, and the entire self-recovering structure 30 is sewn onto the membrane of the free section 22. In this embodiment, the free segments 22 of the two membranes are attached together, the self-recovering structure 30 is sewn to the outside of one of the membranes, and the curled portion 32 is curled toward the other membrane, as shown. Figure 13 As shown.

[0050] In this embodiment, as Figure 14 As shown, the central angle γ corresponding to the bending of the curved segment 32a is greater than 90°, so that the curled portion 32 of the self-recovering structure 30 can drive the corresponding membrane to curl, ensuring the curled edge effect of the curled portion 32 on the distal transverse opening 221 of the free segment 22, as shown. Figure 13 As shown.

[0051] The extension direction of the extension segment 32b can extend along the tangent direction of the end of the bend segment 32a away from the axial support portion 31, or it can continue to bend and extend towards the axial support portion 31 along the bending direction of the bend segment 32a; there is no limitation on this. Figure 13-14 As shown, the wire diameter of the extension section 32b is smaller than that of the bending section 32a. The bending section 32a causes the self-recovering structure 30 to form a self-curling shape at the far end of the free section 22. In its natural state, the curled part 32 curls the far end of the free section 22 to block the transverse opening 221, thereby improving the blocking effect and promoting the embolization of the false cavity. Figure 15 This illustrates the self-recovering structure 30, which allows the sheath core 91a to naturally curl up as it passes through the one-way valve member 20. Figure 12-13 The natural state (curled state) unfolds to Figure 15 In the unnatural state of axial expansion, after the occlusion stent 100 is successfully released, the sheath core 91a is withdrawn from the transverse opening 221 of the one-way valve component 20. The distal end of the one-way valve component 20 is rolled up and sealed under the self-recovery action of the self-recovery structure 30. The self-recovery rolled edge design can increase the reliability of closure without increasing the complexity of the surgical operation or the operation time.

[0052] The self-recovering structure 30 can be made of elastic materials such as nickel-titanium alloy or polymer fibers. In this embodiment, the self-recovering structure 30 is a shape memory material such as nickel-titanium alloy wire, and also includes a limiting part 33. The limiting part 33 is located at the proximal end of the axial support part 31 and is bent into a ring shape along the plane of the free segment 22 along the axial support part 31. The self-recovering structure 30 is generally fixed to the diaphragm by binding wire, and is fixed to the diaphragm of the free segment 22 by tying a knot at the end of the binding wire. The ring shape at the proximal end of the self-recovering structure 30 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 slip 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 near the bend section 32a to the end away from the bend section 32a. The extension section 32b can be polished and refined into a tapered shape using nickel-titanium alloy wire, which reduces the curling force exerted on the tail end of the self-recovering structure 30 when the sheath core 91a is withdrawn, making it easier to withdraw the sheath core 91a.

[0054] In other implementations, such as Figure 16-17As shown, the self-recovering structure 40 includes an axial support portion 41, a coiled portion 42, and a limiting portion 43, with at least two axial support portions 41. The self-recovering structure 40 also includes a lateral support portion 44, which comprises a coiled waveform unit connected between two adjacent axial support portions 41. The portion of the waveform unit parallel to the axial support portion 41 constitutes the lateral support portion 44 of the self-recovering structure, and the coiled portion of the waveform unit constitutes the coiled portion 42. The two ends of the waveform structure are respectively connected to the distal ends of two elastic wires, and the waveform structure exhibits the same bending trend in the axial direction as the bend 32a. This waveform structure can extend for 2-4 wave cycles in the lateral direction. The lateral support 44 can abut 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-recovering structure 40, so that when the sheath core passes through the one-way valve component 20, the distal end of the self-recovering structure 40 is straightened along the axis under the support of the sheath core; when the sheath core is removed from the occlusion support 100, the self-recovering structure 40 returns to its natural state, so that the curled part 42 of the self-recovering structure 40 can drive the corresponding diaphragm to curl, ensuring the curled part 42 has a curling effect on the lateral opening 221 at the distal end of the free segment 22.

[0055] In other implementations, such as Figure 18-19 As shown, the self-recovering structure 50 includes an axial support portion 51 and a coiling portion 52. The coiling portion 52 is connected to the distal end of the axial support portion 51. The axial support portion of the self-recovering structure 50 has a mesh structure. The self-elastic metal wire forming the mesh can be a nickel-titanium alloy wire with a wire diameter ranging from 0.08 mm to 0.25 mm. Within this range, the wire diameter can prevent the problem that if the wire diameter is too small, the self-recovering elasticity of the coiling portion will be insufficient to drive the diaphragm to coil; it can also prevent the wire diameter from being too large, resulting in too much coiling force when it comes into contact with the sheath core, which would affect the sheath core's withdrawal. Figure 18-19 As shown, in this embodiment, the wire diameter is 0.1 mm. The self-recovering structure 50 may include one curled mesh structure or two curled mesh structures. When the self-recovering structure 50 includes one curled mesh structure, the mesh structure of the self-recovering structure 50 is attached to the outer side of one of the membranes and sewn to the membrane. The distal end of the mesh structure is bent to form a curled portion 52. In its natural state, the mesh structure curls the distal end of the free segment 22, thereby achieving a curled edge effect at the distal end of the free segment 22 to seal the transverse opening 221.

[0056] In other implementations, such as Figure 20-25As shown, when the self-recovering structure 60 includes two coiled mesh structures, the self-recovering structure 60 includes a first coiled structure 601 and a second coiled structure 602. The first coiled structure 601 includes a connected axial support portion 61 and a coiled portion 62. The first coiled structure 601 extends along the free segment 22 and is integrally fitted to the outer side of one of the membranes and sewn to the membrane. The coiled portion 62 of the first coiled structure 601 is coiled in the direction of the other membrane, thereby causing the distal end of the free segment 22 of the membrane to coil in that direction. The second coiled structure 602 includes a connected support segment 6021 and a coiled covering segment 6022. The proximal end of the support segment 6021 is connected to another membrane on the other side of the free segment 22, and the proximal end of the second coiled structure 602 is flush with or nearly flush with the proximal end of the first coiled structure 601 (nearly flush means that the axial length of one side exceeds the other side by no more than 2 mm). The distal end of the support segment 6021 is connected to the end of the curled covering segment 6022 near the connecting segment. Except for its proximal end, which is connected to the free segment 22, the support segment 6021 is suspended within the covering support structure. The curled covering segment 6022, in its natural state, curls up and covers the outer (distal) side of the curled portion 62, as shown below. Figure 20-21 As shown, the curling direction of the curled covering section 6022 is opposite to the curling direction of the curled portion 62, so that the self-recovering structure 60, in its natural state (when the self-recovering structure 60 is not subjected to external force, in this invention, it means that the sheath core is withdrawn from the occlusion support 100 and the free segment 22 of the one-way valve component is not supported by the sheath core), such as Figure 20-21 As shown, the curled covering section 6022 covers the distal side of the curled portion 62.

[0057] like Figure 22-25 The diagram illustrates the process by which the conveying device delivers the occlusion support 100 into the dummy cavity 1002 and releases the occlusion support 100 within the dummy cavity 1002. Figure 22 As shown, at this time, the occlusion bracket 100 is loaded in the conveying device, and the conveying device (conveyor system) carries the occlusion bracket 100 to the release point in the false cavity 1002; as Figure 23-24 As shown, the self-recovering structure 60 of the one-way valve component is in an unnatural state of axial expansion due to the sheath core assembly passing through the one-way valve component. In this unnatural state, the distal end of the axially expanded coiled covering section 6022 extends beyond the distal end of the axially expanded coiled portion 62, causing the distal end of the second coiled structure 602 to extend beyond the distal end of the first coiled structure 601 when the sheath core assembly passes through the one-way valve component. The occlusion stent 100 is gradually released as the sheath is withdrawn. Figure 23 The middle part is a schematic diagram showing the state of the sheath 92 being retracted to the expanded and released portion of the covered stent 10; Figure 24 The sheath 92 is retracted to the distal end of the covered stent 10 so that the covered stent is fully released, but the sheath core has not yet been released.

[0058] After the sheath is retracted to release the distal end of the covered stent, the covered stent has achieved wall-mounted release. If a post-release structure is provided at the proximal end of the covered stent, the sheath core assembly is controlled to complete the post-release of the proximal bare wave coil (not shown in the figure). If no post-release structure is provided, the sheath core can be further retracted to allow the sheath core to withdraw from the one-way valve component.

[0059] like Figure 25 As shown, during the axial withdrawal of the sheath core 91a from the one-way valve component, the tip 911 first loses its abutment against the first coiled structure 601. The coiled portion 62 of the first coiled structure 601 first causes the distal end of the free segment 22 to coil, thereby blocking the transverse opening 221. Further withdrawal of the sheath core causes the distal end of the second coiled structure 602 to lose its abutment against the tip 911, and the coiled covering segment 6022 of the second coiled structure 602 naturally returns to its coiled state, thus covering the outside of the coiled portion 62, as shown. Figure 21 As shown (the natural state of the self-recovering structure 60 naturally curled), it can improve the sealing effect and promote the embolization of the false cavity 1002.

[0060] This embodiment also includes a blocking system, such as Figure 26-27 As shown, it includes a delivery device 90 and a blocking support 100 as described in this embodiment. The delivery device 90 includes a sheath core assembly 91 and a sheath tube 92. The distal end of the one-way valve component 20 is open (in conjunction with...). Figure 11-20 and Figure 23-24 As shown, the sheath-core assembly 91 enters from the distal end of the one-way valve member 20 and exits from the proximal end of the one-way valve member 20. The sheath-core assembly 91 includes a sheath core 91a and a tip head 911 located proximal to the sheath core 91a for guiding delivery. The sheath-core assembly 91 may also include a post-release structure, with a bare wave coil correspondingly provided at the proximal end of the occlusion stent 100, which cooperates with the post-release structure to realize the post-release of the proximal end of the occlusion stent.

[0061] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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 embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An occlusion stent, characterized by, The occlusion stent comprises a covered stent and a one-way valve member, the one-way valve member is arranged in a hollow cavity of the covered stent, the one-way valve member comprises a connected segment and a free segment, the connected segment is connected to the covered stent in a circumferential direction away from one end of the free segment, the occlusion stent further comprises a self-recovery structure arranged at the free segment, the self-recovery structure comprises a curling portion away from an end of the connected segment, and the curling portion has a shape memory function; The one-way valve member comprises at least two leaflets, adjacent edges of the at least two leaflets are connected to each other to form a funnel-shaped structure, the funnel-shaped structure comprises a wide part and a narrow part, the wide part is the connected segment, and the narrow part is the free segment; The leaflets at the free segment gradually approach from a proximal end to a distal end, thereby forming a transverse opening at the distal end of the free segment, the curling portion is naturally curved in a natural state, thereby driving the distal end of the free segment to curl and achieve a curling effect, so as to occlude the transverse opening, and the curling portion can be stretched straight under an external force to make the transverse opening in an open state.

2. The occlusion stent of claim 1, wherein, The self-recovery structure comprises an axial support portion, and the curling portion is connected to an end of the axial support portion away from the connected segment.

3. The occlusion stent of claim 2, wherein, The axial support portion and the curling portion are elastic wires, the curling portion comprises a bending segment and an extension segment, the bending segment connects the axial support portion and the extension segment, and a wire diameter of the extension segment is smaller than a wire diameter of the bending segment.

4. The occlusion stent of claim 3, wherein, The wire diameter of the extension segment gradually decreases from one end close to the bending segment to an end away from the bending segment.

5. The occlusion stent of claim 2, wherein, The number of the axial support portions is at least two, the self-recovery structure further comprises a curled wave unit connected between adjacent two axial support portions, a portion of the wave unit parallel to the axial support portions is a transverse support portion of the self-recovery structure, and a curled portion of the wave unit is the curling portion.

6. The occlusion stent of claim 2, wherein, The axial support portions of the self-recovery structure are in a net structure.

7. The occlusion stent of claim 2, wherein, The self-recovery structure comprises a second curling structure, the axial support portion and the curling portion extend along the free segment and are arranged at one side of one leaflet at the free segment, and curl towards another leaflet; the second curling structure comprises a support segment and a curling covering segment connected to each other, a proximal end of the support segment is connected to the another leaflet at the free segment, a distal end of the support segment is connected to an end of the curling covering segment close to the connected segment, a curling direction of the curling covering segment is opposite to a curling direction of the curling portion, so that the curling covering segment covers the distal end side of the curling portion when the self-recovery structure is in a natural state.

8. The occlusion stent of claim 7, wherein, When the sheath core assembly passes through the one-way valve member, a distal end of the curling covering segment unfolded in an axial direction exceeds a distal end of the curling portion unfolded in an axial direction.

9. The occlusion stent of claim 1, wherein, The wide part comprises a large opening end away from the narrow part, and the large opening end is connected to the covered stent in a circumferential direction.

10. An occlusion system, characterized by The occlusion stent comprises a one-way valve member, a stent body and a connecting member, the one-way valve member is connected to the stent body through the connecting member, the one-way valve member is provided with a plurality of valve leaflets, the valve leaflets are arranged in a plurality of valve leaflet groups, each valve leaflet group is provided with a plurality of valve leaflets, the valve leaflets in each valve leaflet group are arranged in a plurality of valve leaflet rows, the valve leaflets in each valve leaflet row are arranged in a plurality of valve leaflet columns, the valve leaflets in each valve leaflet column are arranged in a plurality of valve leaflet rows, the valve leaflets in each valve leaflet row are arranged in a plurality of valve leaflet columns, the valve leaflets in each valve leaflet column are arranged in a plurality of valve leaflet rows, the valve leaflets in each valve leaflet row are arranged in a plurality of valve leaf

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