Plugging support and plugging system
By designing the sealing stent, the connecting segment and free segment structure of the unidirectional valve member are used to solve the problem of dilation and rupture of the false cavity caused by blood reflux after TEVAR surgery, and effective blood flow sealing and false cavity thrombization are achieved.
Patent Information
- Application Number
- CN202311302576.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-10-09
- Publication Date
- 2025-04-11
- Estimated Expiration
- 2043-10-09
AI Technical Summary
After TEVAR surgery, the false lumen caused blood reflux due to the SINE produced at the distal end of the stent, causing the false lumen to continue to expand or even rupture.
A sealing stent is provided, including a coating stent and a one-way valve member, with at least two axial arrangements, and the connecting segment and the free segment structure are designed to prevent blood flow.
By increasing the reliability of sealing, blood flow is prevented from flowing backwards in the false cavity, the false cavity is plucked, and the false cavity is effectively prevented from dilation and rupture.
Smart Images

Figure CN119791902A_ABST
Abstract
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 (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 then expanded and even ruptured. Figure 1 shown. Summary of the invention
[0004] A technical problem solved by the present invention is how to provide a blocking stent with better blocking effect to prevent blood reflux.
[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 at least two one-way valve components are arranged along the axial direction.
[0006] A technical effect of an embodiment of the present invention is that by arranging at least two one-way valve components along the axial direction, the sealing reliability is increased, the blood flow backflow in the false lumen is prevented, and the embolization of the false lumen is promoted.
[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 in Example 1 of the present invention;
[0010] Figure 3 A three-dimensional structural diagram of the occlusion stent provided in Example 1 of 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 a one-way valve component provided in Example 1 of 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 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;
[0019] Fig.12It is a schematic diagram of 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 perpendicular to the direction of the connecting line L5;
[0020] Figures 13a-13g The present invention provides Fig.12 Schematic diagram of different implementations of setting the developing member at the same viewing angle (the viewing angle when releasing is from bottom to top in the figure);
[0021] Fig.14a It is a schematic diagram of the projection form of the first developing member and the second developing member provided by the present invention on the vertical plane of the first cross section;
[0022] Fig.14b It is a schematic diagram of another projection form of the first developing member and the second developing member provided by the present invention on the vertical plane of the first cross section;
[0023] Fig.14c It is a schematic diagram of another projection form of the first developing member and the second developing member provided by the present invention on the vertical plane of the first cross section;
[0024] Fig.15 A schematic diagram of the position of the developing member in a top view in an embodiment of the present invention in which the flat surface of the developing member is arranged parallel to the first cross section;
[0025] Fig.16 A schematic diagram of the structure of the conveying system provided by the present invention;
[0026] Fig.17 A schematic diagram of the delivery system provided by the present invention releasing the occluding stent into the false lumen;
[0027] Fig.18 This is a schematic structural diagram of a one-way valve component provided in Example 2 of the present invention;
[0028] Fig.19 This is a schematic diagram of two membrane sheets of the one-way valve component provided in Example 2 of the present invention being laid flat on a plane when not sewn together;
[0029] Fig. 20 A schematic diagram of a top view of the occluding stent provided in Example 2 of the present invention when it is placed in a false lumen (the extension direction of the straight line where the radial extrusion force F or F' of the main chest stent on the occluding stent is located is consistent with the direction of the connecting line L5);
[0030] Fig.21 Schematic diagram of another embodiment of the one-way valve component provided in Example 2 of the present invention having a ridge;
[0031] Fig. 22A schematic diagram showing that when the direction F (F') of the radial extrusion force of the main chest stent on the first one-way valve component of the occluding stent provided in Example 3 of the present invention is perpendicular to the direction of the line L5, in a top view, the second one-way valve component can be arranged within the β angle range shown in the figure;
[0032] Fig.23 A schematic top view of the first one-way valve component and the second one-way valve component provided in Embodiment 3 of the present invention when the included angle β1 is 15°;
[0033] Fig.24 for Fig.23 A schematic diagram of the position of the second one-way valve component relative to the first one-way valve component in a top view when the direction F (F') of the radial extrusion force of the chest main stent on the first one-way valve component of the occluding stent is perpendicular to the direction of the connecting line L5;
[0034] Fig.25 A three-dimensional structural diagram of a one-way valve component provided in Example 4 of the present invention;
[0035] Fig.26 A schematic diagram of two membrane sheets constituting a one-way valve component provided by Embodiment 4 of the present invention being unfolded along a plane when not fixed to a stent graft;
[0036] Fig. 27 A schematic diagram of the woven structure of the connecting section provided in Example 4 of the present invention;
[0037] Fig.28 A front view schematic diagram of the free-segment knitting structure provided by Example 4 of the present invention;
[0038] Fig.29 A schematic diagram of another one-way valve component provided by Embodiment 4 of the present invention, wherein two membrane sheets are unfolded along a plane when not fixed to a stent graft;
[0039] Fig.30 A three-dimensional structural diagram of another one-way valve component provided in Example 4 of the present invention;
[0040] Fig.31 A side view of the reverse side of the first free diaphragm and the front side of the second free diaphragm facing the inner side of the free section provided in Example 4 of the present invention;
[0041] Fig.32 A side view of the front side of the first free diaphragm and the back side of the second free diaphragm facing the inner side of the free section provided by Embodiment 4 of the present invention;
[0042] Fig.33 This is a side view of the front side of the first free diaphragm and the front side of the second free diaphragm facing the inner side of the free section provided by Embodiment 4 of the present invention. DETAILED DESCRIPTION
[0043] 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.
[0044] 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.
[0045] "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; because 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 the proximal end of the occluding stent. 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.
[0046] Example 1
[0047] The present invention provides a blocking stent 100 and a blocking system, such as Figure 2-17 As 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.
[0048] like Figure 2-4As shown, the coated stent 10 is a tubular structure with openings at both ends. The coated stent 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 coated stent 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.
[0049] 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.
[0050] 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 into a circular ring shape and sutured to the inner side of the proximal end of the coated stent 10, 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 21 toward the small end, the two diaphragms gradually approach each other, and the distal end of the free section 22 is 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 segment 21, and the narrow portion 204 is the free segment 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 segment 21 connects the entire one-way valve component 20 to the stent graft 10 through the large end 203a, and the free segment 22 is suspended in the stent graft 10 because it is the narrow portion 204, and 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 also extend beyond the distal end of the stent graft 10, and there is no limitation on this.
[0051] 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 along the edges 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 coated stent 10 to form a funnel-shaped one-way valve component 20, so that the proximal end of the connecting section 21 (the large end 203a) is sutured circumferentially to the proximal port of the coated stent 10, as shown in FIG. Figure 6 Combination Figure 5 The free section 22 may be in the form 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.
[0052] 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.
[0053] 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.
[0054] 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.
[0055] Taking the thoracic aorta as an example, Figure 7As shown, the distal end of the occluding stent 100 is placed flush or nearly flush with the distal end of the main thoracic stent 1010, and a developing piece can be provided at the distal end of the occluding stent 100 to be compared with the developing piece at the distal end of the main thoracic 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 main thoracic stent implanted in the aortic cavity, the occluding stent 100 is squeezed by the main thoracic stent 1010, and 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 main thoracic stent and the outer wall 1003c of the blood vessel, the main thoracic stent applies a radial squeezing force F to the occluding stent 100, and the outer wall 1003c of the blood vessel corresponding to the false cavity applies a radial squeezing force F' to the occluding stent 100 (the squeezing forces F and F' are in opposite directions, as shown in FIG. 1 ). Figure 10-13e 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:
[0056] When the occluding stent 100 is subjected to radial extrusion force from the main thoracic 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 in the non-extrusion direction (if the circular shape is elliptical after extrusion, the extrusion direction is along the short axis direction of the ellipse, and the non-extrusion direction is along the long axis direction of the ellipse). The bulge extends axially to form a tendency for the diaphragm to bulge toward the outside of the one-way valve component 20. When this tendency 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 thoracic 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, such as Fig.10 shown.
[0057] When the direction of the radial extrusion force F of the main thoracic stent is perpendicular to the direction of the line L5 formed by the above two connecting points (when the angle is 90°) or biased towards perpendicular, wherein biased towards perpendicular means that the angle between the direction of the radial extrusion force F and the direction of the line L5 formed by the above two connecting points is in the range of [45°, 90°), the two diaphragms of the one-way valve component 20 will be more inclined to squeeze each other due to the direction of the extrusion force F of the main thoracic stent being perpendicular or biased towards perpendicular, and the closed state of the transverse opening 221 of the main thoracic stent will be more reliable.
[0058] The blocking stent 100 includes a developing member 80, and the distal end 211 of the connecting section 21 is in the shape of an elongated strip. The distal end of the elongated strip includes a major axis 2111 and a minor axis 2112 (the major axis 2111 is the farthest straight line distance along the length direction of the elongated strip, and the minor axis 2112 is the farthest straight line distance along the width direction of the elongated strip). In this embodiment, the major axis 2111 is a connecting straight line formed between two connecting points of the connecting sections of the two diaphragms at the distal ends of the connecting sections, and an axial section (a section extending along the axial direction) passing through both ends of the major axis 2111 is defined as a first section 212, such as Figure 3-4 shown.
[0059] When the direction of the radial extrusion force F of the main chest support is perpendicular to the direction of the line L5 formed by the two connection points (that is, the direction of the radial extrusion force F is perpendicular to the extension direction of the transverse opening 221), Figure 11-12As shown, the two diaphragms of the one-way valve component 20 are further squeezed and brought closer to each other, so that the closed state of the transverse opening 221 of the blocking stent will be more reliable. In this embodiment, the distal end of the connecting section 21 and the proximal end of the free section 22 are long strips. At this time, the one-way valve component 20 is squeezed by the main chest stent so that the two diaphragms are further squeezed and brought closer to each other, thereby making the closed state of the transverse opening 221 more reliable. In this embodiment, the extension direction of the connecting line L5, the direction of the long axis 2111 of the long strip opening, and the extension direction of the transverse opening 221 are all the same, so the connecting line L5 and the long axis 2111 of the long strip opening are all on the first section 212, and the first section 212 includes a first plane portion 212a intersecting with the blocking stent 100. In this embodiment, the developing member 80 includes at least two, and is arranged on the first plane portion 212a. Since the first planar portion 212a passes through the lumen diameter of the coated stent 10, the developing member 80 includes a first developing member 81 and a second developing member 82, and the connecting line of the developing points passing through the first developing member 81 and the second developing member 82 is the lumen diameter of the coated stent. Therefore, when the connecting line of the developing points passing through the first developing member 81 and the second developing member 82 is parallel to the diameter in the radial section of the coated stent 10, when the occluding stent is released, the area where the projections of the first developing member 81 and the second developing member 82 on the vertical plane of the first section 212 (the plane where the connecting line of the developing points is located) are partially or completely overlapped to judge the circumferential release position of the occluding stent so that the direction of the connecting line L5 formed by the above two connecting points is perpendicular to the direction of the radial extrusion force F of the main chest stent, thereby ensuring that the closed state of the lateral opening 221 of the occluding stent is more reliable.
[0060] In other embodiments, the first developing member and the second developing member may not be disposed on the first planar portion, and it is only necessary to ensure that the connecting line of the developing points of the first developing member and the second developing member is approximately parallel to the diameter of the radial cross section of the stent graft (approximately parallel means that the angle between the connecting line of the developing points and the diameter of the radial cross section of the stent graft is within 5°). Figure 13g As shown, when the occluding stent is released, the circumferential release position of the occluding stent can be judged so that the direction of the line L5 formed by the above two connecting points is approximately perpendicular to the direction of the radial extrusion force F of the main chest stent (approximately perpendicular means that the angle error is within 5° compared to vertical), thereby ensuring that the closure state of the transverse opening of the occluding stent is more reliable.
[0061] In other embodiments, the first developing member 81 and the second developing member 82 are on the same radial section of the coated stent, and the angle between the line connecting the developing points of the first developing member 81 and the second developing member 82 and the first section is in the range of [0°, 45°]. That is, when releasing the blocking stent, the circumferential release position of the blocking stent can be determined by partially or completely overlapping the area where the projections of the first developing member 81 and the second developing member 82 on the vertical plane connecting the two developing points are located, so that the direction of the connecting line L5 formed by the above two connecting points of the released blocking stent is perpendicular or offset to the direction of the radial extrusion force F of the main chest stent, such as Fig.13f As shown, the angle between the line connecting the developing points of the first developing member and the second developing member and the first cross section is 45 degrees, and the blocking bracket is released. When the area where the projections of the first developing member 81 and the second developing member 82 on the vertical plane connecting the two developing points partially overlap or completely overlap, the angle between the direction of the connecting line L5 formed by the above two connecting points and the direction of the radial extrusion force F of the main chest bracket is also 45 degrees, which is a critical value of deviating from the vertical. When the angle between the connecting line of the developing points of the first developing member and the second developing member and the first cross section is greater than 45 degrees, when the circumferential position of the blocking bracket release is judged by partially overlapping or completely overlapping the area where the projections of the two developing members on the vertical plane connecting the two developing points are located, the angle between the direction of the connecting line L5 formed by the above two connecting points and the direction of the radial extrusion force F of the main chest bracket is less than 45 degrees, which will cause the two diaphragm parts at the free section position to move away from each other and make the transverse opening in an open state.
[0062] The developing member 80 includes a first developing member 81 and a second developing member 82. When the projection shape of one of the developing members is completely under the shadow of the other developing member, the projection shape display is the same as that of only one developing member. In this embodiment, Figures 14a-14cAs shown, the axial projection length of the first developer 81 on the vertical plane of the first cross-section 212 (the vertical plane is the plane of the figure or the paper surface) is greater than the axial projection length of the second developer 82 on the vertical plane of the first cross-section 212, and the lateral projection length of the second developer 82 on the vertical plane of the first cross-section 212 is greater than the lateral projection length of the first developer 81 on the vertical plane of the first cross-section 212, so that the projected parts of the first developer 81 and the second developer 82 on the vertical plane of the first cross-section 212 overlap, and in the same viewing angle, both the projections of the first developer 81 and the second developer 82 on the vertical plane of the first cross-section 212 are reflected, which can reduce the possibility of misjudgment. The first developer 81 can be set as a vertical structure, such as "1-shaped", "8-shaped", etc., and the second developer 82 can be set as a horizontal structure, such as "∞-shaped", "-shaped", etc. In other embodiments, the first developer 81 can be a horizontal structure and the second developer 82 can be a vertical structure, which is not limited here. The first developer can also be set in a hollow structure shape, and the second developer can be completely sleeved in the hollow structure projected by the first developer. For example, the first developer is "O-shaped", and the second projection is "5", "G-shaped" or "8-shaped", and the outer dimension of the second developer is smaller than the inner dimension of the hollow first developer, so that when judging the circumferential position of the release of the occluding stent, the structure of the first developer is sleeved outside the structure of the second developer, that is, it is sufficient that both the first developer and the second developer are reflected in the projection on the vertical plane of the connection line of the two development points.
[0063] The first developer 81 and the second developer 82 are symmetrically arranged on the covered stent 10, so that the connection line of the development points passing through the first developer 81 and the second developer 82 is substantially parallel to the diameter in the radial cross-section of the covered stent, as Fig.13a 、 Fig.13e and Figure 13g shown. In other embodiments, the first developer 81 and the second developer 82 are on the same radial cross-section diameter of the covered stent, and the included angle range between the connection line of the development points passing through the first developer 81 and the second developer 82 and the first cross-section is in [0°, 45°], which can ensure that when releasing the occluding stent, it is judged whether the circumferential release position of the occluding stent is accurate according to whether the projected areas of the first developer and the second developer on the vertical plane of the connection line of the two development points partially overlap or completely overlap. This is because if the connection line of the development points is along the viewing angle, it is perpendicular to the radial extrusion force F of the thoracic aortic stent. When the included angle between the connection line of the development points and the first cross-section is 45°, it makes the radial extrusion force F of the thoracic aortic stent and the connection line L5 formed by the above two connection points deviate to the perpendicular (the included angle is 45°) critical point, which can maintain the reliability of the closed state of the transverse opening 221 of the thoracic aortic stent, as Fig.13f shown. The first developer 81 is arranged on the covered stent 10, and the second developer 82 is arranged on the one-way valve member 20, such as Figure 13b-13cAs shown, the first developing member and the second developing member are on the same radial cross-sectional diameter of the stent graft, and the angle between the connecting line of the developing points of the first developing member and the second developing member and the first cross-sectional area is 0°; the first developing member 81 and the second developing member 82 can also be symmetrically arranged on the one-way valve member 20, such as Figure 13d-13f As shown, the first developing member and the second developing member are on the same radial cross-sectional diameter of the stent graft, wherein: Fig.13f In the figure, the angle between the line connecting the developing points of the first developing member 81 and the second developing member 82 and the first cross section is 45°.
[0064] like Figure 13b-13c As shown, the distance between the first developing member 81 and the second developing member 82 can be greater than the lumen radius of the stent graft 10, or less than the lumen radius of the stent graft 10. When the distance between the two developing members 80 is greater than the lumen radius R of the stent graft 10 (such as Fig.13b ), the distance between the two developing members 80 is smaller than the lumen radius R (e.g. Fig.13c ), the distance between the two developing parts 80 is far, which can reduce the possibility of visual errors.
[0065] In other embodiments, Fig.15 As shown, the developing member 80 can be arranged at a position where the vertical distance from the first section is the lumen radius of the coated stent (when the occluding stent is in an uncompressed natural state). The developing member is a recognizable shape structure or number. The shape plane of the developing member can be sutured to the membrane. When the occluding stent is released, the shape structure of the developing member is not visible (that is, the right side or left side of the developing member is seen), which is the circumferentially releasable position. For example, taking the "8" shape sutured to the coating along the axial direction as an example, the "8" shape is the front when viewed straight on. When the viewing angle is to see the left and right sides of the "8", the "8" shape cannot be seen. At this time, the viewing direction is consistent with the direction of the line L5 formed by the above two connecting points, and the radial extrusion force F of the main chest stent is perpendicular to the direction of the line L5 formed by the above two connecting points. Only one developing member 80 can be provided, or two can be provided. Fig.15 As shown, two developing members 80 are symmetrically arranged on the blocking bracket 100. The arrangement of two or more developing members 80 can reduce the possibility that a single developing member 80 is squeezed in the radial direction, causing the developing member 80 to twist and affect the direction judgment. When the blocking bracket 100 is transported to the false cavity by the transport device 90, the orientation is determined by only seeing the side of the developing member 80. The developing member 80 can be set to a recognizable shape structure of "0", "8", or "U". The circumferential orientation is determined by the shape of the developing member 80. When the shape is not visible (the viewing angle is from bottom to top in the figure), and only the side of the developing member 80 can be seen, the direction of the squeezing force F of the main chest bracket is perpendicular to the direction of the connecting line L5 formed by the above two connection points and the extension direction of the transverse opening 221, as shown in FIG. Fig.15As shown, the two membranes of the one-way valve component 20 are further pressed against each other, so that the closed state of the transverse opening 221 of the main chest stent is more reliable.
[0066] This embodiment also includes a blocking system, such as Figure 16-17 As shown, it includes a delivery device 90 and the above-mentioned occluding stent 100, the delivery device 90 includes a sheath core component 91 and a sheath tube 92, the distal end of the one-way valve component 20 is in an open state, and the sheath core component 91 is inserted 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, and the sheath core component 91 includes a sheath core 91a and a tip head 911 provided at the proximal end of the sheath core 91a for guiding delivery. In other embodiments, the sheath core component 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 100.
[0067] Example 2
[0068] Embodiment 2 proposes another occluding stent and occluding system, wherein the occluding stent includes a stent graft 10 and a one-way valve component, such as Figure 18-21 As shown, the stent graft of Example 2 is the same as the stent graft 10 of Example 1, and the characteristic parts of the one-way valve component of Example 2 and the one-way valve component 20 in Example 1 that may be used or appropriated are not described in detail here. Figure 18-21 As shown, the main difference is that the one-way valve component of Example 2 includes a ridge 23, and the ridge 23 protrudes toward the inner side of the one-way valve component 20. In this embodiment, the ridge 23 can be provided without distinguishing the circumferential orientation of the occluding stent 100 relative to the main chest stent when the occluding stent is delivered into the false cavity, and the stability of the closed state of the distal transverse opening 221 of the free segment 22 can still be maintained when the occluding stent is released into the false cavity.
[0069] In this embodiment, by using the Figure 3-6 As shown, because the two diaphragms are gradually closed from the proximal end to the distal end, and when the diaphragms are relatively fitted, the edges on the same side are sewn together in pairs, and the two diaphragms have a tendency to fit at the distal end, but because their proximal ends are sutured to the stent graft 10 in the circumferential direction, the distal end port of the connecting section 21 is in the shape of an elongated strip, and the elongated distal end port includes a major axis 2111 and a minor axis 2112, the connecting section 21 includes a first region 213, and the major axis 2111 includes a first endpoint 2111a and a second endpoint 2111b, refer to Figure 5-6As shown, the plane passing through the first end point 2111a in the axial direction and perpendicular to the long axis 2111 is defined as the first axial plane S1, and the plane passing through the second end point 2111b in the axial direction and perpendicular to the long axis 2111 is defined as the second axial plane S2; the first axial plane S1 and the second axial plane S2 respectively form four intersection lines (L1, L2, L3, L4) with the connecting section 21, and a first area 213 is formed between the two intersection lines (curves) on the same side of the long axis 2111 (a first area 213 is formed on each of the two diaphragms), and the first area 213 and / or the free section 22 include the ridge 23. The ridge 23 can be only provided in the first area 213, as shown in FIG. Figure 18-20 As shown; it may also be provided only in the free section 22 (not shown); it may also be provided with the ridge 23 in both the free section 22 and the first region 213 (not shown).
[0070] The ridge 23 can be formed by sewing part of the connecting section and / or part of the free section with sutures 231. The ridge 23 can be arranged in the first region 213 and / or the free section 22 and extend in the axial direction; it can also be arranged circumferentially at the connection between the connecting section and the free section to block the tendency of the connecting section to deform and prevent the two membranes from moving away from each other and extending toward the free section. In this embodiment, the ridge 23 is only arranged in the first region 213. Sutures 231 are arranged in the first region 213 to sew to form the ridge 23 protruding toward the inner side of the one-way valve component, and the ridge 23 extends in the axial direction, such as Fig.18 As shown. Since the ridge 23 is convex toward the inner side of the one-way valve component 20, the ridge 23 has a tendency to convex toward the inner side of the one-way valve component 20 in the axial direction before it is subjected to the squeezing force of the main chest stent, so that the direction of the radial squeezing force F applied by the main chest stent to the occluding stent is the same as the direction of the line formed by the two connection points L5 of the occluding stent 100. Even if the tendency of the ridge 23 to convex toward the inner side of the one-way valve component 20 extends axially toward the free section 22, the two diaphragm parts at the position of the free section 22 will have a tendency to approach each other, so that the closed state of the transverse opening 221 of the main chest stent will be more reliable, as shown in FIG. Fig. 20 When the direction of the radial extrusion force F of the main chest stent is perpendicular to the direction of the line L5 formed by the two connection points and the extension direction of the transverse opening 221, the two diaphragms of the one-way valve component 20 are further squeezed against each other, so that the closed state of the transverse opening 221 of the main chest stent will be more reliable. Fig.12 shown.
[0071] Since the first region 213 corresponds to the position of the free segment 22 in the axial direction, as shown in FIG. Figure 18-20As shown, when the ridge 23 is arranged in the first area 213 and extends axially, when the blocking stent 100 is in a natural state, the ridge 23 has a tendency to bulge toward the inner side of the one-way valve component 20. When the blocking stent 100 is subjected to the radial extrusion force FF' of the chest main stent, the extension direction of the straight line is consistent with the extension direction of the connecting line L5 formed by the above two connection points (the angle is 0), the ridge 23 bulging toward the inner side of the one-way valve component 20 arranged in the first area 213 will drive the two diaphragms to approach each other and extend toward the free section 22, thereby driving the two diaphragm parts of the free section 22 to have a tendency to approach each other, so that the closed state of the transverse opening 221 of the chest main stent will be more reliable. Since the ridge 23 is a bulge toward the inner side of the one-way valve component 20, the ridge 23 is arranged in the connecting section 21. When the free section 22 is set to a smaller size (to meet the passage and withdrawal of the sheath core component 91), it does not affect the withdrawal of the sheath core component 91.
[0072] In other embodiments, the ridge 23 may also be arranged in a non-first region 213 of the connecting segment 21, or may not be arranged along the axial direction, as long as the ridge 23 protrudes toward the inner side of the one-way valve component 20. For example, when arranged in the transverse direction, the tendency of the diaphragm parts of the free segment 22 to move away from each other caused by the radial compression of the connecting segment 21 by the main chest stent may also be blocked. When the ridge 23 is arranged in the transverse direction or obliquely, the ridge 23 may pass through the first region 213, or be arranged circumferentially at the connecting position of the connecting segment 21 and the free segment 22, and the blocking effect is better than that when it does not pass through the first region 213.
[0073] In other embodiments, the connecting section 21 of the one-way valve component 20 is arc-shaped, and the arc is convex toward the inner side of the one-way valve component 20, such as Fig.21 shown.
[0074] This embodiment also provides a blocking system, including a delivery device 90 and a blocking stent as described above, wherein the delivery device 90 includes a sheath core assembly 91 and a sheath tube 92, wherein the distal end of the one-way valve component 20 is in an open state, so that the sheath core assembly 91 can penetrate from the distal end of the one-way valve component 20 and pass out from the proximal end of the one-way valve component 20, and 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 can also include a rear release structure, and a bare wave ring is correspondingly provided at the proximal end of the blocking stent 100, which cooperates with the rear release structure to realize the rear release of the proximal end of the blocking stent 100. The schematic diagram of the blocking system can be referred to Figure 16-17 .
[0075] Example 3
[0076] Embodiment 3 proposes another occluding stent and occluding system, wherein the occluding stent includes a coated stent and a one-way valve component. The coated stent of Embodiment 3 is the same as the coated stent 10 of Embodiment 1. The one-way valve component of Embodiment 3 and the one-way valve component 20 of Embodiment 1 that may be used or adapted are not described in detail here. Figure 22-24 As shown, the main difference is that in Example 3, at least two one-way valve components are arranged along the axial direction. The arrangement of two one-way valve components can increase the sealing reliability, prevent the backflow of blood in the false lumen, and promote the embolization of the false lumen.
[0077] In this embodiment, reference Figure 3-Figure 6 As shown, on this basis, two one-way valve components 20 are arranged axially, and the end port of the free section 22 close to the connecting section 21 is in the shape of a long strip. When the adjacent edges of the first diaphragm 201 and the second diaphragm 202 at the connecting section 21 are connected in pairs, a first connecting line 2012 and a second connecting line 2021 are formed, and the first connecting line 2012 and the second connecting line 2021 are symmetrically arranged in the axial direction. When the proximal end of the connecting section 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. Since the first diaphragm 201 and the second diaphragm 202 are both cut and formed as one piece, the extension direction of the connecting line is consistent with the extension direction of the transverse opening 221. The long strip-shaped opening includes a long axis 2111 and a short axis 2112, the one-way valve component 20 includes a first one-way valve component 20a and a second one-way valve component 20b, the first one-way valve component 20a includes a first long axis 2111c and a first short axis 2112c, the second one-way valve component 20b includes a second long axis 2111d and a second short axis 2112d, and the angle β between the first long axis 2111c and the second long axis 2111d satisfies: 0≤β≤45°. The first one-way valve component 20a includes a first connecting segment and a first free segment, and the first free segment is in a long strip shape at one end (proximal end) close to the first connecting segment; the second one-way valve component 20b includes a second connecting segment and a second free segment, and the second free segment is in a long strip shape at one end (proximal end) close to the second connecting segment.
[0078] In this embodiment, the blocking stent includes a developing part (81, 82), and the distal end 211 of the connecting section 21 of the first one-way valve component 20a is in the shape of an elongated strip, which includes a first major axis 2111c and a first minor axis 2112c. The axial section defined by the two ends of the first major axis 2111c is the first section 212, and reference can be made to the number indications in Example 1.
[0079] The first cross section 212 includes a first plane portion 212a intersecting with the occluding stent, and the developing parts include at least two, and the two developing parts correspond to the positions of the first one-way valve component 20a. The specific arrangement of the developing parts in this embodiment relative to the first one-way valve component 20a can refer to the arrangement of the developing parts in Example 1, which will not be repeated here; the difference from the arrangement of the developing parts in Example 1 is that, in this embodiment, the developing parts can be arranged corresponding to the first one-way valve component 20a, or corresponding to the second one-way valve component 20b, or corresponding to both the first one-way valve component 20a and the second one-way valve component 20b, and there is no limitation here. In this embodiment, the first developing part 81 and the second developing part 82 are arranged on the first plane portion, and the two developing points are respectively at the two ends of the lumen diameter of the coated stent, such as Fig.24 shown.
[0080] The setting of the developing member (81, 82) can be used as a basis for adjusting the circumferential position of the blocking stent 100 during the process of releasing the blocking stent 100, so that the direction of the line L5 formed by the two connection points of the first one-way valve component 20a and the blocking stent 100 is as perpendicular as possible to the direction of the radial extrusion force F of the main chest stent. In this case, the angle β between the first long axis 2111c and the second long axis 2111d is set to meet the following conditions: 0≤β≤45°, such as Fig. 22 The area corresponding to the middle β angle can be the area where the long axis 2111 of the second one-way valve component 20b is located, which can ensure that the angle between the direction of the line formed by the two connection points when the second one-way valve component 20b is circumferentially connected to the occluding stent 100 and the direction of the radial extrusion force F of the main thoracic stent is between 45° and 90°, thereby reducing the influence of the radial extrusion force of the main thoracic stent on the reliability of the closed state of the transverse opening 221 of the free section 22 of the first one-way valve component 20a and the second one-way valve component 20b.
[0081] like Fig. 22 As shown, the area formed by the two dotted lines G1 and G2 at an angle of 45° to the first long axis 2111c of the first one-way valve component 20a satisfies the two areas on the left and right sides of the above-mentioned angle β (two areas corresponding to the two β angles), and the second long axis 2111d is arranged along this area. Figure 23-24As shown, the angle β1 between the second long axis 2111d and the first long axis 2111c is 15°, and the first one-way valve component 20a can be symmetrically arranged on both sides of the coated stent 10 according to the first developing member 81 and the second developing member 82. In the process of releasing the occluding stent, the direction of the first long axis 2111c of the first one-way valve component 20a (the direction of the connecting line L5 formed by the connecting points on the two connecting lines connecting the first one-way valve component 20a and the coated stent) is perpendicular to the radial supporting force direction of the main chest stent, and the second one-way valve component The angle between the direction of the second long axis 2111d of 20b (the direction of the line formed by the connecting points on the two connecting lines connecting the second one-way valve component 20b and the coated stent) and the radial supporting force direction of the thoracic main stent is 75° (angle > 45°), which can make the direction of the radial extrusion force exerted on the two one-way valve components 20 and the direction of the line L5 between the two connecting points on their respective corresponding one-way valve components 20 inconsistent as much as possible, thereby further ensuring the closing reliability of the transverse opening 221, thereby ensuring the blocking effect and promoting false lumen embolization.
[0082] In other embodiments, the developing member 80 may be disposed at a position whose vertical distance from the first cross section is the lumen radius of the coated stent (when the occluding stent is in an uncompressed natural state), and the specific configuration may refer to Example 1.
[0083] The present embodiment also includes a blocking system, including a delivery device 90 and a blocking stent as described above, wherein the delivery device 90 includes a sheath core assembly 91 and a sheath tube 92, wherein the distal ends of the two one-way valve components 20 are in an open state, so that the sheath core assembly 91 can penetrate from the distal end of the one-way valve component 20 and pass out from the proximal end of the one-way valve component 20, and 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 can also include a rear release structure (not shown in the figure), and a bare wave ring (not shown in the figure) is correspondingly provided at the proximal end of the blocking stent, which cooperates with the rear release structure to realize the rear release of the proximal end of the blocking stent. The schematic diagram of the blocking system can be referred to. Figure 16-17 .
[0084] Example 4
[0085] Embodiment 4 proposes another occluding stent and occluding system, wherein the occluding stent includes a stent graft and a one-way valve component, such as Figure 25-33 As shown, the stent graft of Example 4 is the same as the stent graft 10 of Example 1, and the characteristic parts of the one-way valve component of Example 4 and the one-way valve component 20 in Example 1 that may be used or borrowed are not repeated here, wherein the distal end of the connecting segment 21 is connected to the proximal end of the free segment 22, as shown in FIG. Figure 25-33As shown, the main difference is that the connecting segment 21 and the free segment 22 in the one-way valve component provided in Example 4 are connected by a connecting element 50, and the connecting element 50 can be a suture or glue, so that the connecting segment 21 and the free segment 22 are sutured and connected by sutures, or connected by glue. The connecting segment 21 and the free segment 22 can be overlapped and then sutured by sutures at the overlapped position or connected by glue at the overlapped position.
[0086] The one-way valve component includes a first connecting diaphragm 203, a second connecting diaphragm 204, a first free diaphragm 205 and a second free diaphragm 206. The diaphragm of the connecting segment and the diaphragm of the free segment on the same side are not the same diaphragm and can be sutured and connected by sutures. The first free diaphragm 205 and the second free diaphragm 206 are gradually close to each other from the proximal end to the distal end, so as to form a transverse opening 221 at the distal end of the free segment; the first connecting diaphragm 203 is opposite to the second connecting diaphragm 204, and is connected in pairs at adjacent edges in the axial direction to form a connecting segment 21; the first connecting diaphragm 203 includes a first long side 2031 at the proximal end and a first short side 2032 at the distal end, and the second connecting diaphragm 204 includes a second long side 2041 at the proximal end and a second short side 2042 at the distal end; the first free diaphragm 205 includes a first corner point 2051 and a second corner point 2052 arranged at the proximal end, the first corner point 2051 and the second corner point 2052 form the proximal side of the first free diaphragm 205, the second free diaphragm 206 includes a third corner point 2061 and a fourth corner point 2062 arranged at the proximal end, the third corner point 2061 and the fourth corner point 2062 form the proximal side of the second free diaphragm 206; the first free diaphragm 205 is opposite to the second free diaphragm 206, and is connected in pairs at adjacent edges in the axial direction to form a free segment 22, and the first corner point 2051 is connected to the fourth corner point 2062, and the second corner point 2052 is connected to the third corner point 2061. Among them, when the direction of the line L5 formed by the two connecting points as described in Example 1 is subjected to an extrusion force perpendicular to or inclined to be perpendicular to it, since the connecting section 21 and the free section 22 are connected by a connecting element 50, the connecting element 50 can block the tendency of the two diaphragms extending axially toward the distal end to the free section to move away from each other, which may be caused by the first connecting diaphragm 203 and the second connecting diaphragm 204. The mutual distance between the two diaphragms extends axially toward the distal end to move away from each other, thereby avoiding the fitting state between the first free diaphragm 205 and the second free diaphragm 206 from being affected by external extrusion pressure, so as to ensure the stability of the closed state of the lateral opening at the distal end of the free section.
[0087] In one of the embodiments, the first connecting diaphragm 203 and the first free diaphragm 205 can be an integral structure, and then a connecting element is set at the connection, or the two disconnected diaphragms can be connected together by a connecting element 50; similarly, the second connecting diaphragm 204 and the second free diaphragm 206 can be an integral structure, and then a connecting element is set at the connection, or the two disconnected diaphragms can be connected together by a connecting element 50; as long as a connecting element is set between one of the connecting diaphragms and the free diaphragm on the same side, the tendency of the first connecting diaphragm and the second connecting diaphragm to move away from each other caused by the extrusion pressure of the connecting section can be blocked at the connection, thereby avoiding the fitting state between the first free diaphragm 205 and the second free diaphragm 206 from being affected by the external extrusion pressure, so as to ensure the stability of the closed state of the far end lateral opening 221 of the free section 22.
[0088] In one embodiment, the materials of the connecting section 21 and the free section 22 are both polyethylene terephthalate (PET), the connecting section 21 is a woven structure, and the free section 22 is a knitted structure. Knitted fabrics have extensibility and resilience, wherein extensibility refers to the performance of the knitted fabric to extend in size under external force, and resilience refers to the ability of the knitted fabric to return to its original size after the external force is removed. Fig. 27 shows the woven structure, Fig.28 A knitted structure is shown.
[0089] like Fig. 27 As shown, since the woven structure is formed by overlapping and interlacing the warp yarns and the weft yarns one above the other, the warp yarns and the weft yarns do not bend in the fabric structure, and there is no lateral or longitudinal deformation, so the woven extensibility and resilience are small; Fig.28 As shown, the knitted yarn is formed by connecting the coil structure with each other, and the coil structure is easy to deform, so the knitted structure has greater extensibility and resilience. The free segment adopts a knitted structure, so that the free segment has extensibility and resilience. On the one hand, when the blocking stent is subjected to the extrusion force from the main chest stent, because the knitted structure is softer than the woven structure, and the woven structure of the connecting segment 21 and the knitted structure of the free segment 22 are separate membranes connected together by a connecting element, the free segment can be unaffected by the tendency of the two membranes of the connecting segment to move away from each other (first, the tendency of the two membranes of the free segment to move away from each other is not easy to be transmitted toward the free segment; second, the connecting element has the function of blocking the transmission of the tendency), thereby ensuring the stability of the closed state of the lateral opening at the far end of the free segment; on the other hand, the lateral dimension of the far end of the free segment can be made smaller, so that the opening of the lateral opening at the far end of the free segment is smaller, and at the same time, the sheath core can be smoothly withdrawn.
[0090] The first free membrane 205 and the second free membrane 206 of the free section 22 can be formed by weft knitting, so that the free section has extensibility and resilience in the transverse direction. Weft knitting uses one or more yarns to form coils (continuous coils) in sequence along the transverse direction (weft) of the fabric surface, such as Fig.28 When the weft knitting method is adopted, when the membrane of the free section 22 is connected to the connecting section 21, the coil structure in the weft knitting structure is arranged in the transverse direction to ensure that the transverse extensibility of the free section is greater than the axial extensibility.
[0091] In other embodiments, the membrane of the free section 22 may be knitted by other knitting methods other than weft knitting, as long as the free section has transverse extensibility and resilience. The transverse extensibility of the free section may also be greater than the axial extensibility, and the free section has transverse resilience.
[0092] In other embodiments, Fig.29 As shown, the free section may also include a connecting portion 22a and a constricted portion 22b, wherein the proximal end of the connecting portion 22a is connected to the distal end of the connecting portion 21, and the transverse width of the constricted portion 22b is smaller than the transverse width of the connecting portion 22a. Since the free section 22 has extensibility and resilience in the transverse direction, the circumferential dimension of the distal end portion (constricted portion 22b) of the free section 22 may be set to be smaller than the circumference at the maximum transverse dimension of the tip head, that is, a constricted structure is set at the distal end of the free section to make the transverse opening degree of the distal end of the free section smaller, and at the same time, the sheath core can be smoothly withdrawn. Among them, the circumference of the constricted portion 22b can be set to 50% to 70% of the circumference at the maximum transverse dimension of the tip head, which can ensure the constriction effect and facilitate the withdrawal of the sheath core. Among them, if the constricted portion 22b is too small, it is not conducive to the withdrawal of the sheath core, or the transverse deformation of the constricted portion 22b is too large and it is not conducive to rebounding to the original size; if the constricted portion 22b is too large, the constriction effect may not be obvious.
[0093] In other embodiments, the connecting section 21 and the free section 22 are sutured and connected in the circumferential direction by means of suture lines, so that the connecting section and the free section are interconnected in the axial direction.
[0094] Since the free section 22 is a knitted structure, the knitted fabric itself also has curling properties; curling properties refer to the property that the edge of the knitted fabric appears to be curled up in a natural state; this is because the yarn is bent during the looping process, and its elastic force tries to straighten it again. The bent yarn in the edge loop tries to straighten and cause curling.
[0095] In this embodiment, the first free diaphragm 205 and the second free diaphragm 206 are opposite to each other and are completely connected to each other at adjacent edges in the axial direction to form a connection section. Figure 25-26As shown, the axial sewing of the distal ends of the first free diaphragm 205 and the second free diaphragm 206 together can inhibit the curling of the edge of the knitted fabric to a certain extent, prevent the distal edges of the two free diaphragms (the reverse sides of the two free diaphragms are opposite) from curling outward, and avoid the situation where the closed state of the distal lateral opening of the free section cannot be guaranteed.
[0096] The first free diaphragm 205 and the second free diaphragm 206 are partially or completely sewn together along the adjacent edges in the axial direction. In other embodiments, Fig.30 As shown, the first free membrane sheet and the second free membrane sheet are opposite to each other, and the adjacent edges in the axial direction are not completely connected to form a connection section 220 (partial sewing), the axial edges of the proximal portions 220a of the first free membrane sheet and the second free membrane sheet are connected, and the distal portions 220b are not connected in the axial direction to form a free curling portion. In a natural state, the edge of the weft-knitted plain fabric has an obvious curling phenomenon, and the curling directions of the weft-knitted plain fabric are different in the transverse and longitudinal (axial) directions. Along the longitudinal (axial) direction of the coil, its edge (such as Fig.28 The left and right edges in the loop are curled toward the reverse side (back side) of the fabric; along the transverse direction of the loop, its edge ( Fig.28 The upper and lower edges of the fabric are curled toward the front of the fabric. Taking the weft knitting plain needle structure as an example, Fig.30 As shown, the first free diaphragm and the second free diaphragm each include a front side and a back side; in one embodiment, the continuous coils ( Fig.28 The first free membrane 205 and the second free membrane 206 face the same direction and are sewn together to form a free segment that passes through the proximal and distal ends. Fig.31 As shown, that is, the reverse side of the first free diaphragm 205 and the front side of the second free diaphragm 206 are both facing the inner side of the free section. Due to the lateral direction along which the coils extend, the edge coils are curled toward the front side of the fabric. That is, the distal ends of the first free diaphragm 205 and the second free diaphragm 206 are both curled in the same direction. Fig.31 As shown, the first free diaphragm 205 and the second free diaphragm 206, Fig.31 In the figure, the left side of each of them is the front side, and the right side of each of them is the back side, and the front side of the first free film 205 and the front side of the second free film 206 are both facing the left side of the figure, and the adjacent edges are not completely connected to form a connecting section 220, that is, the back side of the first free film 205 is opposite to the front side of the second free film 206, and at this time, the free rolled portions of the first free film 205 and the second free film 206 are both curled toward the left side. In other embodiments, such as Fig.32As shown, the front side of the first free diaphragm 205 and the back side of the second free diaphragm 206 are both facing the inner side of the free section, and the free rolled portions of the first free diaphragm 205 and the second free diaphragm 206 are both curled toward the right side.
[0097] In other embodiments, Fig.33 As shown, the continuous coils (transverse direction) of the first free membrane 205 and the second free membrane 206 are arranged to extend along the axial direction of the vertical occlusion stent, and the front of the first free membrane 205 and the front of the second free membrane 206 are attached to each other and the edges are sewn in pairs to form a free segment with the proximal end and the distal end connected, that is, the front of the first free membrane 205 and the front of the second free membrane 206 are both facing the inner side of the free segment 220. Fig.28 In the horizontal direction shown, the edge coils are curled toward the front side of the fabric, and the free curling portions of the distal edges of the first free membrane sheet 205 and the second free membrane sheet 206 are both curled toward the inner side of the free section 220. Fig.33 As shown, the first free diaphragm 205 is located on the left side of the second free diaphragm 206. Fig.33 The right side of the first free diaphragm 205 is the front side, and the left side is the back side; the second free diaphragm 206 is located on the right side of the first free diaphragm 205, and its left side is the front side, and the right side is the back side. Since the axial edges of the proximal parts of the first free diaphragm 205 and the second free diaphragm 206 are connected, and the distal parts are not connected along the axial direction to form a free roll, that is, the distal part of the free section is not sewn and will not inhibit the curling of the knitted fabric, the free rolls at the distal ends of the first free diaphragm 205 and the second free diaphragm 206 are both curled toward their respective front sides, so that the closed state of the distal transverse opening of the free section is better. In other embodiments, the front side of the first free diaphragm and the front side of the second free diaphragm are both facing the inner side of the free section, and the distal end of the first free diaphragm can also exceed the distal end of the second free diaphragm (not shown), so that the free roll of the first free diaphragm has a tendency to wrap around the free roll of the second free diaphragm, so that the closed state of the distal transverse opening of the free section is better.
[0098] The present invention also provides a blocking system, including a delivery device and a blocking stent as described above, wherein the delivery device includes a sheath core assembly and a sheath tube, wherein the distal end of the one-way valve component is in an open state, and the sheath core assembly is provided for the one-way valve component to penetrate from the distal end and pass out from the proximal end of the one-way valve component, and the sheath core assembly includes a sheath core and a tip head provided at the proximal end of the sheath core for guiding the delivery. The sheath core assembly may also include a rear release structure, and a bare wave ring is correspondingly provided at the proximal end of the blocking stent, and cooperates with the rear release structure to realize the rear release of the proximal end of the blocking stent.
[0099] 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.
[0100] 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 connecting segment is circumferentially connected to the coated stent at one end away from the free segment, and at least two one-way valve components are arranged along the axial direction.
2. The occluding stent according to claim 1, characterized in that: The free section has an elliptical or long-mouth shape at one end close to the connecting section, and the elliptical or long-mouth shape includes a major axis and a minor axis. The one-way valve component includes a first one-way valve component and a second one-way valve component. The first one-way valve component includes a first major axis and a first minor axis, and the second one-way valve component includes a second major axis and a second minor axis. The angle β between the first major axis and the second major axis satisfies: 0≤β≤45°.
3. The occluding stent according to claim 1, characterized in that: The one-way valve component comprises at least two membrane sheets, and adjacent edges of at least two membrane sheets are connected to each other in pairs to form an axisymmetric structure of a funnel-shaped structure.
4. The occluding stent according to claim 1, characterized in that: The occluding stent includes a developing member, the one-way valve component includes a first one-way valve component and a second one-way valve component, the distal end of the connecting section of the first one-way valve component is in a long strip shape, the long strip shape includes a first major axis and a first minor axis, and an axial section passing through two ends of the first major axis is defined as a first section; The developing member comprises a first developing member and a second developing member, and a connecting line through developing points of the first developing member and the second developing member is substantially parallel to a diameter in a radial cross section of the stent graft; Or, the developing member includes a first developing member and a second developing member, the first developing member and the second developing member are on the same radial cross-sectional diameter of the stent graft, and the angle between a line connecting the developing points of the first developing member and the second developing member and the first cross-sectional area is in the range of [0°, 45°]; Alternatively, the vertical distance between the developing component and the first cross section is the lumen radius of the stent graft.
5. The occluding stent according to claim 4, characterized in that: The axial projection length of the first developing member on the vertical plane of the first section is greater than the axial projection length of the second developing member on the vertical plane of the first section, and the lateral projection length of the second developing member is greater than the lateral projection length of the first developing member.
6. The occluding stent according to claim 4, characterized in that: The first developing member and the second developing member are symmetrically arranged on the blocking bracket member.
7. The occluding stent according to claim 4, characterized in that: The first developing member is disposed on the stent graft, and the second developing member is disposed on the one-way valve component.
8. The occluding stent according to claim 4, characterized in that: The first developing member and the second developing member are symmetrically arranged on the blocking stent, and the vertical distances between the first developing member and the second developing member and the first cross section are both equal to the lumen radius of the coated stent.
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 9, 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.
Citation Information
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