Blocking stent and blocking system
By designing an axially positioned unidirectional valve component in the occlusion stent, the problem of blood backflow in the false lumen after TEVAR was solved, achieving effective occlusion and preventing the false lumen from expanding and rupturing.
Patent Information
- Application Number
- CN202311302576.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2023-10-09
- Publication Date
- 2026-01-06
- Estimated Expiration
- 2043-10-09
AI Technical Summary
The problem of blood backflow into the false cavity after TEVAR surgery, leading to continuous expansion or even rupture of the false cavity, cannot be effectively blocked by existing stents.
Design an occlusion stent comprising a covered stent and unidirectional valve components, wherein at least two unidirectional valve components are arranged axially to occlude the hollow cavity or extended cavity of the stent. The axially arranged unidirectional valve components prevent blood backflow, and the occlusion effect is achieved in conjunction with a delivery device.
It increases the reliability of occlusion, prevents backflow of blood within the false lumen, promotes embolization of the false lumen, and reduces the risk of false lumen expansion.
Smart Images

Figure CN119791902B_ABST
Abstract
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). (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 1002 to continuously expand or even rupture, as... Figure 1 As shown. Summary of the Invention
[0004] One technical problem solved by this invention is how to provide an occlusion stent with good occlusion effect to prevent blood backflow.
[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 extended 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, and at least two one-way valve components being provided axially.
[0006] One technical effect of one embodiment of the present invention is that by providing at least two one-way valve components along the axial direction, the reliability of occlusion is increased, blood flow is prevented from flowing back into the false lumen, and false lumen embolization is promoted.
[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 This is a three-dimensional structural diagram of the occlusion support provided in Embodiment 1 of the present invention;
[0010] Figure 3 This is a three-dimensional structural diagram of the occlusion stent provided in Embodiment 1 of 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 in Embodiment 1 of 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 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.
[0019] Figure 12A schematic diagram from a top view when the direction F (F') of the radial compressive force of the occlusion stent provided by the present invention is perpendicular to the direction of the connecting line L5;
[0020] Figures 13a-13g The present invention provides Figure 12 Schematic diagrams of different implementations of setting up the developing element from the same perspective (the viewing angle during release is from bottom to top in the diagram);
[0021] Figure 14a A schematic diagram of the projection shape of the first developing element and the second developing element provided by the present invention on the vertical plane of the first cross section.
[0022] Figure 14b This is a schematic diagram of another projection shape of the first developing element and the second developing element provided by the present invention on the vertical plane of the first cross section.
[0023] Figure 14c This is a schematic diagram showing another projection of the first developing element and the second developing element provided by the present invention on the vertical plane of the first cross section.
[0024] Figure 15 A schematic diagram of the position of the developing element from a top view in an embodiment where the flat surface of the developing element is parallel to the first cross section provided by the present invention.
[0025] Figure 16 This is a schematic diagram of the conveying system provided by the present invention;
[0026] Figure 17 This is a schematic diagram of the delivery system provided by the present invention releasing the sealing support into the false cavity;
[0027] Figure 18 This is a schematic diagram of the unidirectional valve component provided in Embodiment 2 of the present invention;
[0028] Figure 19 This is a schematic diagram of the two diaphragms of the unidirectional valve component provided in Embodiment 2 of the present invention laid flat on a plane when they are not sewn together.
[0029] Figure 20 This is a schematic diagram from a top view of the occlusion stent provided in Embodiment 2 of the present invention when it is placed in a false cavity (the extension direction of the straight line where the occlusion stent is subjected to the radial compressive force F or F' of the main chest stent is consistent with the direction of the connecting line L5).
[0030] Figure 21 This is a schematic diagram of another embodiment of the unidirectional valve component with a ridge provided in Embodiment 2 of the present invention;
[0031] Figure 22When the direction F (F') of the radial compressive force of the first unidirectional valve component of the occlusive stent provided in Embodiment 3 of the present invention is perpendicular to the direction of the connecting line L5, the second unidirectional valve component can be arranged within the β angle range shown in the figure from a top view.
[0032] Figure 23 This is a 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] Figure 24 for Figure 23 A schematic diagram of the position of the second one-way valve component relative to the first one-way valve component from a top-down perspective when the direction of the radial compressive force F (F') of the first one-way valve component of the occlusive stent is perpendicular to the direction of the line L5.
[0034] Figure 25 This is a three-dimensional structural diagram of the unidirectional valve component provided in Embodiment 4 of the present invention;
[0035] Figure 26 This is a schematic diagram of the two diaphragms constituting the unidirectional valve component being unfolded along a plane when they are not fixed to the covered support, as provided in Embodiment 4 of the present invention;
[0036] Figure 27 This is a schematic diagram of the weave structure of the connecting section provided in Embodiment 4 of the present invention;
[0037] Figure 28 This is a front view of the structure of the free-segment knitting provided in Embodiment 4 of the present invention;
[0038] Figure 29 This is a schematic diagram of the two diaphragms that constitute a unidirectional valve component, which are not fixed to the covered support, unfolded along the plane according to another embodiment of the present invention (4).
[0039] Figure 30 This is a three-dimensional structural diagram of another unidirectional valve component provided in Embodiment 4 of the present invention;
[0040] Figure 31 This is a side view of the reverse side of the first free diaphragm and the front side of the second free diaphragm, which are opposite to each other with their sides facing the inside of the free segment, as provided in Embodiment 4 of the present invention.
[0041] Figure 32 This is a side view of the front of the first free diaphragm and the back of the second free diaphragm, which are opposite to each other on the inside of the free segment, according to Embodiment 4 of the present invention.
[0042] Figure 33 This is a side view of the front of the first free diaphragm and the front of the second free diaphragm facing the inside of the free segment, as provided in Embodiment 4 of the present invention. Detailed Implementation
[0043] 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.
[0044] 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.
[0045] "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 the proximal end of the occluding stent. 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.
[0046] Example 1
[0047] This invention provides an occlusion stent 100 and an occlusion system, such as Figure 2-17 As 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 lumens that require occlusion to prevent blood backflow.
[0048] like Figure 2-4As 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 stent 100 implantation 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 displacement or shortening of the occlusion stent 100 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.
[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 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.
[0050] 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 section is opened into a ring and sewn to the inner side of the proximal end of the membrane support 10, 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 section 21 to the small end, the two membranes gradually approach each other, and the distal ends of the free section 22 are almost flat and attached. The closer the two membranes are to the distal end of the free section 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 one-way 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.
[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 each other. The two axial edges of the first diaphragm 201 are respectively abutted against the two axial edges of the second diaphragm 202. Adjacent axial edges can be sutured together, but 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 (larger opening 203a) 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.
[0052] 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.
[0053] 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.
[0054] 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.
[0055] Taking the thoracic aorta as an example, such as Figure 7As shown, the distal end of the occlusion stent 100 is placed flush with or nearly flush with the distal end of the main thoracic 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 main thoracic 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 main thoracic stent implanted in the aortic lumen. The occlusion stent 100 is compressed by the main thoracic stent 1010. Since the connecting segment 21 of the one-way valve component 20 is connected to the covered stent 10, the free segment 22 is suspended. When the occlusion stent 100 is compressed by the main thoracic stent and the vessel wall 1003c, the main thoracic stent applies a radial compressive force F to the occlusion stent 100, and the vessel wall 1003c corresponding to the false lumen applies a radial compressive force F' to the occlusion stent 100 (the compressive forces F and F' are in opposite directions, e.g., ...). Figure 10-13e 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:
[0056] 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 forming a bulge (a circular shape becomes similar to an ellipse after compression; the compression direction is along the minor axis of the ellipse-like shape, and the non-compression direction is along the major axis of the ellipse-like shape) in the axial direction towards the outer side of the one-way valve component 20. This bulge extends axially, causing the diaphragm to tend to bulge outward towards the one-way valve component 20. When this tendency 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.
[0057] When the direction of the radial compressive force F of the main thoracic stent is perpendicular to (when the angle is 90°) or slightly perpendicular to the direction of the line L5 formed by the two connection points, where slightly perpendicular means that the angle between the direction of the radial compressive force F and the direction of the line L5 formed by the two connection points is in the range of [45°, 90°), the two diaphragms of the one-way valve component 20 will tend to compress each other more due to the direction of the compressive force F of the main thoracic stent being perpendicular to or slightly perpendicular to each other, and the closure state of the transverse opening 221 of the main thoracic stent will be more reliable.
[0058] The occlusion support 100 includes a imaging element 80. The distal port 211 of the connecting segment 21 is elongated, and the distal port of the elongated segment 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 segment, and the minor axis 2112 is the farthest straight-line distance along the width direction of the elongated segment). In this embodiment, the major axis 2111 is the connecting straight line formed between the two connection points at the distal end of the connecting segment of the two diaphragms. The axial section (the section extending along the axial direction) passing through both ends of the major axis 2111 is defined as the first section 212. Figure 3-4 As shown.
[0059] When the direction of the radial compressive force F of the main chest support is perpendicular to the direction of the line L5 formed by the two connection points mentioned above (that is, the direction of the radial compressive force F is perpendicular to the extension direction of the transverse opening 221), such as Figure 11-12As shown, the two diaphragms of the one-way valve component 20 are further compressed and brought closer together, making the closure of the transverse opening 221 of the occlusion stent more reliable. In this embodiment, the distal end of the connecting segment 21 and the proximal end of the free segment 22 are elongated. Because the one-way valve component 20 is compressed by the main thoracic stent, the two diaphragms are further compressed and brought closer together, thus making the closure 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 elongated opening, and the extension direction of the transverse opening 221 are all the same. Therefore, the connecting line L5 and the long axis 2111 of the elongated opening are both on the first cross-section 212, which includes a first planar portion 212a intersecting with the occlusion stent 100. In this embodiment, at least two imaging elements 80 are included and disposed on the first planar portion 212a. Since the first planar portion 212a passes through the lumen diameter of the covered stent 10, the developing element 80 includes a first developing element 81 and a second developing element 82, and the connecting line of the developing points of the first developing element 81 and the second developing element 82 is the lumen diameter of the covered stent, when the connecting line of the developing points of the first developing element 81 and the second developing element 82 is parallel to the diameter in the radial section of the covered stent 10, it is possible to determine the circumferential release position of the occlusive stent by partially or completely overlapping the projections of the first developing element 81 and the second developing element 82 on the vertical plane of the first section 212 (the plane where the developing point connecting line is located) when releasing the occlusive 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 compressive force F of the main chest stent, thereby ensuring a more reliable closure state of the transverse opening 221 of the occlusive stent.
[0060] In other embodiments, the first and second developing elements may not be located on the first planar portion, provided that the line connecting the developing points of the first and second developing elements is approximately parallel to the diameter in the radial section of the coating support (approximately parallel means that the angle between the line connecting the developing points and the diameter in the radial section of the coating support is within 5°). Figure 13g As shown, when releasing the occlusion stent, the circumferential release position of the occlusion stent can be determined so that the direction of the line L5 connecting the two connection points is approximately perpendicular to the direction of the radial compressive force F of the main chest stent (approximately perpendicular means that the angle error is within 5° compared to perpendicular), thereby ensuring a more reliable closure of the lateral opening of the occlusion stent.
[0061] In other embodiments, the first developing element 81 and the second developing element 82 are on the same radial cross-section of the coated stent, and the angle between the line connecting the developing points of the first developing element 81 and the second developing element 82 and the first cross-section is within the range of [0°, 45°]. Therefore, when releasing the occlusive stent, the circumferential release position of the occlusive stent can be determined by the partial or complete overlap of the areas where the projections of the first developing element 81 and the second developing element 82 on the vertical plane connecting the two developing points lie. This ensures that the direction of the line L5 connecting the two connection points of the released occlusive stent is perpendicular or slightly perpendicular to the direction of the radial compressive force F of the main chest stent. Figure 13f As shown, when the angle between the line connecting the development points of the first and second development elements and the first cross-section is 45°, the occlusion stent is released. When the projections of the first and second development elements 81 and 82 on the vertical plane connecting the two development points partially or completely overlap, the angle between the direction of the line L5 connecting the two connection points and the direction of the radial compressive force F of the main chest stent is also 45 degrees, which is a critical value of deviating from verticality. However, when the angle between the line connecting the development points of the first and second development elements and the first cross-section is greater than 45°, and the circumferential position of the occlusion stent is determined by the partial or complete overlap of the projections of the two development elements on the vertical plane connecting the two development points, the angle between the direction of the line L5 connecting the two connection points and the direction of the radial compressive force F of the main chest stent is less than 45°. This will cause the two membrane portions at the free segment position to move away from each other, resulting in an open transverse opening.
[0062] The developing element 80 includes a first developing element 81 and a second developing element 82. When the projected shape of one developing element is completely under the shadow of the shape of the other developing element, it is the same as the case when there is only one projected shape. In this embodiment, as shown... 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 that 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 that of the first developer 81 on the vertical plane of the first cross-section 212, so that the projection 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 as a hollow structure, and the second developer can be completely sleeved in the hollow structure of the projection of 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, as long as 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 Figure 13a 、 Figure 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 [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 projection 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 critical point of perpendicularity (the included angle is 45°), which can maintain the reliability of the closed state of the transverse opening 221 of the thoracic aortic stent, as Figure 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 Figures 13b-13cAs shown, the first developing element and the second developing element are on the same radial cross-sectional diameter of the coating support, and the angle between the line connecting the developing points of the first developing element and the second developing element and the first cross-section is 0°; alternatively, the first developing element 81 and the second developing element 82 can be symmetrically arranged on the unidirectional valve component 20, such as... Figure 13d-13f As shown, the first developing element and the second developing element are on the same radial cross-sectional diameter of the coating holder, wherein, Figure 13f In the middle, the angle between the line connecting the developing point of the first developing element 81 and the second developing element 82 and the first cross section is 45°.
[0064] like Figures 13b-13c As shown, the distance between the first developing element 81 and the second developing element 82 can be greater than or less than the lumen radius of the coating support 10. When the distance between the two developing elements 80 is greater than the lumen radius R of the coating support 10 (e.g., ...), the distance between the two developing elements 80 is greater than the lumen radius R of the coating support 10. Figure 13b When the distance between the two developing elements 80 is less than the lumen radius R (e.g., ...), Figure 13c When the distance between the two developing elements 80 is relatively large, the possibility of visual errors can be reduced.
[0065] In other implementations, such as Figure 15 As shown, the developing element 80 can be positioned at a vertical distance from the first cross-section equal to the radius of the covered stent's lumen (when the occluded stent is not compressed in its natural state). The developing element is a recognizable shape or number. The shape plane of the developing element can be sewn onto the membrane. When the occluded stent is released, the circumferentially releasable position is when the shape of the developing element is no longer visible (i.e., the right or left side of the developing element is visible). For example, taking a figure-eight shape sewn axially onto the covered stent as an example, viewing the figure-eight shape directly is the front view. When the viewing angle is to see the left or right sides of the figure-eight, the figure-eight shape is not visible. At this time, the viewing angle direction is consistent with the direction of line L5 formed by the two connection points mentioned above. The radial compressive force F of the main thoracic stent is perpendicular to the direction of line L5 formed by the two connection points mentioned above. Only one developing element 80 can be provided, or two can be provided, such as... Figure 15 As shown, two developing elements 80 are symmetrically arranged on the sealing bracket 100. Using two or more developing elements 80 can reduce the possibility of a single developing element 80 being twisted due to radial compression, affecting the direction determination. When the sealing bracket 100 is transported to the false cavity via the conveying device 90, the orientation is determined by only seeing the side of the developing element 80. The developing element 80 can be set to a recognizable shape structure such as "O", "8", or "U". The circumferential orientation is determined by the shape of the developing element 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 element 80 is visible, the direction of the compressive force F of the main chest support is perpendicular to the direction of the line L5 connecting the two connection points and the extension direction of the transverse opening 221. Figure 15As shown, the two diaphragms of the one-way valve component 20 are further compressed against each other, making the closure of the transverse opening 221 of the main thoracic stent more reliable.
[0066] This embodiment also includes a blocking system, such as Figure 16-17 As shown, the device includes a delivery device 90 and an occlusion stent 100 as described above. The delivery device 90 includes a sheath core assembly 91 and a sheath tube 92. The distal end of the one-way valve member 20 is open, allowing the sheath core assembly 91 to enter from the distal end of the one-way valve member 20 and exit 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. In other embodiments, 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 achieve post-release of the proximal end of the occlusion stent 100.
[0067] Example 2
[0068] Example 2 proposes another occlusion stent and occlusion system, the occlusion stent comprising a covered stent 10 and a one-way valve component, such as Figure 18-21 As shown, the covered stent of Embodiment 2 is the same as the covered stent 10 of Embodiment 1. The unidirectional valve component of Embodiment 2 and the unidirectional valve component 20 of Embodiment 1, or any features that can be reused, will not be described again here. Figure 18-21 As shown, the main difference is that the one-way valve component of Embodiment 2 includes a ridge 23, which protrudes towards the inside of the one-way valve component 20. In this embodiment, the ridge 23 allows for the maintenance of the stability of the closure state of the distal transverse opening 221 of the free segment 22 when the occlusal stent is released into the false lumen, without needing to distinguish the orientation of the occlusal stent 100 circumferentially relative to the main thoracic stent.
[0069] In this embodiment, using the method described in Embodiment 1 Figure 3-6 As shown, because the two membranes gradually taper from the proximal end to the distal end, and when the membranes are fitted together, their edges on the same side are sewn together in pairs, the two membranes tend to fit together at the distal end. However, because their proximal ends are sewn to the membrane support 10 in the circumferential direction, the distal end of the connecting segment 21 is elongated. The elongated distal end includes a major axis 2111 and a minor axis 2112. The connecting segment 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, a plane passing through the first endpoint 2111a along the axial direction and perpendicular to the major axis 2111 is defined as the first axial surface S1, and a plane passing through the second endpoint 2111b along the axial direction and perpendicular to the major axis 2111 is defined as the second axial surface S2. The first axial surface S1 and the second axial surface S2 form four boundary lines (L1, L2, L3, L4) with the connecting segment 21, respectively. A first region 213 is formed between two boundary lines (curves) on the same side of the major axis 2111 (one first region 213 is formed on each of the two diaphragms). The first region 213 and / or the free segment 22 includes the ridge 23. The ridge 23 may only be provided in the first region 213, such as... Figure 18-20 As shown; it can also be set only in the free segment 22 (not shown); or the ridge 23 can be set in both the free segment 22 and the first region 213 (not shown).
[0070] The ridge 23 can be formed by suturing a portion of the connecting segment and / or a portion of the free segment with sutures 231. The ridge 23 can be located in the first region 213 and / or the free segment 22 and extend axially; it can also be located circumferentially at the junction of the connecting segment and the free segment to block the tendency of the connecting segment to deform and prevent the two diaphragms from moving away from each other towards the free segment. In this embodiment, the ridge 23 is only located in the first region 213. A suture 231 is provided in the first region 213 to sew a ridge 23 that protrudes towards the inner side of the one-way valve member, and the ridge 23 extends axially. Figure 18 As shown. Because the ridge 23 protrudes towards the inside of the one-way valve component 20, it already has a tendency to bulge towards the inside of the one-way valve component 20 in the axial direction before being subjected to the compressive force of the main chest stent. This makes the direction of the radial compressive force F applied by the main chest stent to the occlusion stent the same as the direction of the line connecting the two connection points L5 of the occlusion stent 100. Even if the tendency of the ridge 23 to bulge towards the inside of the one-way valve component 20 extends axially towards the free segment 22, the two diaphragm portions at the free segment 22 will tend to move closer to each other, making the closure state of the transverse opening 221 of the main chest stent more reliable. Figure 20 As shown. When the radial compressive force F of the main thoracic stent is perpendicular to the direction of the line L5 connecting the two connection points and the extension direction of the transverse opening 221, the two diaphragms of the one-way valve component 20 further compress against each other, making the closure of the transverse opening 221 of the main thoracic stent more reliable. (Refer to...) Figure 12 As shown.
[0071] Since the first region 213 corresponds to the position of the free segment 22 in the axial direction, as Figure 18-20As shown, when the ridge 23 is located in the first region 213 and extends axially, when the occlusion stent 100 is in its natural state, the ridge 23 has a tendency to bulge towards the inside of the one-way valve component 20. When the occlusion stent 100 is subjected to the radial compressive force FF' of the main thoracic stent and the extension direction of the line L5 connecting the two connection points is consistent with the extension direction (the included angle is 0), the ridge 23 located in the first region 213 that bulges towards the inside of the one-way valve component 20 will cause the two diaphragms to move closer to each other and extend towards the free segment 22, thereby causing the two diaphragm portions of the free segment 22 to tend to move closer to each other, making the closure state of the transverse opening 221 of the main thoracic stent more reliable. Since the ridge 23 is a bulge towards the inside of the one-way valve component 20, setting the ridge 23 in the connecting segment 21 can allow the free segment 22 to be set to a smaller size (to satisfy the passage and withdrawal of the sheath core assembly 91) without affecting the withdrawal of the sheath core assembly 91.
[0072] In other embodiments, the ridge 23 may also be disposed in a non-first region 213 of the connecting segment 21, or it may not be disposed along the axial direction, as long as the ridge 23 protrudes towards the inner side of the one-way valve member 20. For example, when disposed laterally, it can also block the tendency of the diaphragm portions of the free segment 22 to move away from each other due to radial compression of the connecting segment 21 by the main thoracic stent. When the ridge 23 is disposed laterally or obliquely, the ridge 23 may pass through the first region 213, or be disposed circumferentially at the connection position between the connecting segment 21 and the free segment 22, which provides a better blocking effect compared to the case where it does not pass through the first region 213.
[0073] In other embodiments, the connecting segment 21 of the one-way valve component 20 is arc-shaped, and the arc protrudes towards the inner side of the one-way valve component 20, such as... Figure 21 As shown.
[0074] This embodiment also provides an occlusion system, including a delivery device 90 and an occlusion stent as described above. The delivery device 90 includes a sheath core assembly 91 and a sheath tube 92. The distal end of the one-way valve member 20 is open, allowing the sheath core assembly 91 to enter from the distal end of the one-way valve member 20 and exit 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. A bare wave coil is 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 100. A schematic diagram of the occlusion system can be found here. Figure 16-17 .
[0075] Example 3
[0076] Example 3 proposes another occlusion stent and occlusion system. The occlusion stent includes a covered stent and a one-way valve component. The covered stent in Example 3 is the same as the covered stent 10 in Example 1. The one-way valve component in Example 3 is similar to the one-way valve component 20 in Example 1, and any reusable features will not be described here. Figure 22-24 As shown, the main difference is that in Example 3, at least two one-way valve components are provided along the axial direction. Providing two one-way valve components can increase the reliability of occlusion, prevent blood flow back into the false lumen, and promote false lumen embolization.
[0077] In this embodiment, reference Figures 3-6 As shown, two one-way valve components 20 are arranged axially on this basis. The free segment 22 is elongated at one end near the connecting segment 21. When the adjacent edges of the first diaphragm 201 and the second diaphragm 202 at the connecting segment 21 are connected in pairs, a first connecting line 2012 and a second connecting line 2021 are formed. The first connecting line 2012 and the second connecting line 2021 are symmetrically arranged axially. 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. Since the first diaphragm 201 and the second diaphragm 202 are both integrally cut, the extension direction of this line is consistent with the extension direction of the transverse opening 221. The elongated orifice includes a major axis 2111 and a minor 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 major axis 2111c and a first minor axis 2112c. The second one-way valve component 20b includes a second major axis 2111d and a second minor axis 2112d. The included angle β between the first major axis 2111c and the second major axis 2111d satisfies: 0 ≤ β ≤ 45°. Furthermore, the first one-way valve component 20a includes a first connecting segment and a first free segment, with the proximal end of the first free segment near the first connecting segment being elongated. The second one-way valve component 20b includes a second connecting segment and a second free segment, with the proximal end of the second free segment near the second connecting segment being elongated.
[0078] In this embodiment, the occlusion stent includes imaging elements (81, 82), and the distal port 211 of the connecting segment 21 of the first one-way valve component 20a is elongated, which includes a first major axis 2111c and a first minor axis 2112c. The axial section passing through both ends of the first major axis 2111c is defined as the first section 212, which can be referred to in the reference numerals in Embodiment 1.
[0079] The first section 212 includes a first planar portion 212a intersecting with the occlusion stent. The developing element includes at least two components, each corresponding to the position of the first one-way valve component 20a. The specific arrangement of the developing element relative to the first one-way valve component 20a in this embodiment can be referenced from the arrangement of the developing element in Embodiment 1, and will not be repeated here. The difference from the developing element arrangement in Embodiment 1 is that in this embodiment, the developing element can be arranged corresponding to the first one-way valve component 20a, or corresponding to the second one-way valve component 20b, or both corresponding to the first one-way valve component 20a and the second one-way valve component 20b; no limitation is made here. In this embodiment, the first developing element 81 and the second developing element 82 are disposed on the first planar portion, and the two developing points are respectively located at both ends of the lumen diameter of the covered stent. Figure 24 As shown.
[0080] The placement of the imaging elements (81, 82) can serve as a basis for adjusting the circumferential position of the occlusion stent 100 during the release of the occlusion stent 100, ensuring that the line L5 connecting the two connection points of the first one-way valve component 20a and the occlusion stent 100 is as perpendicular as possible to the direction of the radial compressive force F of the main thoracic stent. In this case, the angle β between the first major axis 2111c and the second major axis 2111d is set to satisfy: 0≤β≤45°, as shown below. Figure 22 The region corresponding to the mid-β angle can be the region where the long axis 2111 of the second one-way valve component 20b is located. This can ensure that the angle between the direction of the line connecting the two connection points when the second one-way valve component 20b and the occlusion stent 100 are circumferentially connected and the direction of the radial compressive force F of the main chest stent is between 45° and 90°, thereby reducing the impact of the radial compressive force of the main chest stent on the reliability of the closure state of the transverse opening 221 of the free segment 22 of the first one-way valve component 20a and the second one-way valve component 20b.
[0081] like Figure 22 As shown, the regions formed by the axial sections of the two dashed lines G1 and G2, which form an angle of 45° with the first major axis 2111c of the first one-way valve component 20a, satisfy the two regions on the left and right sides of the aforementioned β angles (two regions corresponding to the two β angles), and the second major axis 2111d is set along this region. Figure 23-24As shown, the angle β1 between the second major axis 2111d and the first major axis 2111c is 15°, and the first one-way valve component 20a can be symmetrically arranged on both sides of the covered stent 10 according to the first imaging element 81 and the second imaging element 82. During the release of the occlusion stent, the direction of the first major axis 2111c of the first one-way valve component 20a (the direction of the line L5 formed by the connection point of the two connecting lines connecting the first one-way valve component 20a and the covered stent) is perpendicular to the radial support force direction of the main chest stent. The second one-way valve component... The direction of the second major axis 2111d of 20b (the direction of the line connecting the two connecting points on the connecting lines of the second one-way valve component 20b and the covered stent) forms an angle of 75° (angle > 45°) with the radial support force direction of the main thoracic stent. This can make the radial compressive force direction of the two one-way valve components 20 as far as possible not to be consistent with the direction of the line L5 connecting the two connecting points on their respective one-way valve components 20. This can further ensure the closure reliability of the transverse orifice 221, thereby ensuring the occlusion effect and promoting pseudo-lumen embolization.
[0082] In other embodiments, the developing element 80 may be located at a position where the vertical distance from the first cross section is the radius of the lumen of the coating support (when the sealing support is not compressed in its natural state), as can be specifically set in Embodiment 1.
[0083] This embodiment also includes an occlusion system, comprising a delivery device 90 and an occlusion stent as described above. The delivery device 90 includes a sheath core assembly 91 and a sheath tube 92. The distal ends of the two one-way valve components 20 are open, allowing the sheath core assembly 91 to enter from the distal end of the one-way valve component 20 and exit from the proximal end of the one-way valve component 20. The sheath core assembly 91 includes a sheath core 91a and a tip head 911 located proximal to the sheath core 91a for guiding delivery. The sheath core assembly 91 may also include a post-release structure (not shown). A bare wave coil (not shown) is correspondingly provided at the proximal end of the occlusion stent, cooperating with the post-release structure to achieve post-release of the proximal end of the occlusion stent. A schematic diagram of the occlusion system can be found in the figure. Figure 16-17 .
[0084] Example 4
[0085] Example 4 proposes another occlusion stent and occlusion system, the occlusion stent comprising a covered stent and a one-way valve component, such as... Figure 25-33 As shown, the covered stent of Example 4 is the same as the covered stent 10 of Example 1. The unidirectional valve component of Example 4 is similar to or can be reused from the unidirectional valve component 20 of Example 1, and its features will not be described again here. Specifically, the distal end of the connecting segment 21 is connected to the proximal end of the free segment 22, as shown... 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 Embodiment 4 are connected by a connecting element 50. The connecting element 50 can be a suture or an adhesive, so that the connecting segment 21 and the free segment 22 are connected by suture or by adhesive. The connecting segment 21 and the free segment 22 can be overlapped and then sutured at the overlap or glued at the overlap.
[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 diaphragms of the connecting segment and the free segment on the same side are not the same diaphragm and can be connected by sutures. The first free diaphragm 205 and the second free diaphragm 206 gradually approach each other from the proximal end to the distal end, thereby forming a transverse opening 221 at the distal end of the free segment. The first connecting diaphragm 203 and the second connecting diaphragm 204 are opposite each other and are 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. The first free diaphragm 205 includes a first corner point 2051 and a second corner point 2052 located at the proximal end, forming the proximal edge of the first free diaphragm 205. The second free diaphragm 206 includes a third corner point 2061 and a fourth corner point 2062 located at the proximal end, forming the proximal edge of the second free diaphragm 206. The first free diaphragm 205 and the second free diaphragm 206 are opposite each other and are connected in pairs at adjacent edges in the axial direction to form a free segment 22. 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. When the line L5 formed by the two connection points described in Embodiment 1 is subjected to a compressive force perpendicular to or inclined to be perpendicular to it, since the connecting segment 21 and the free segment 22 are connected by a connecting element 50, the connecting element 50 can interrupt the tendency of the two diaphragms, which may be separated from each other by the first connecting diaphragm 203 and the second connecting diaphragm 204, to move away from each other along the axial direction to the far end of the free segment. This avoids the adhesion state between the first free diaphragm 205 and the second free diaphragm 206 being affected by the external compressive force, so as to ensure the stability of the lateral opening closure state at the far end of the free segment.
[0087] In one embodiment, the first connecting diaphragm 203 and the first free diaphragm 205 can be an integral structure, with a connecting element provided at the connection point. Alternatively, the two diaphragms can be connected together by the connecting element 50. Similarly, the second connecting diaphragm 204 and the second free diaphragm 206 can be an integral structure, with a connecting element provided at the connection point. Alternatively, the two diaphragms can be connected together by the connecting element 50. By providing a connecting element between one of the connecting diaphragms and the free diaphragm on the same side, the tendency for the first connecting diaphragm and the second connecting diaphragm to move away from each other due to the compressive force on the connecting section can be blocked at the connection point. This prevents the adhesion state between the first free diaphragm 205 and the second free diaphragm 206 from being affected by external compressive force, thus ensuring the stability of the closed state of the transverse opening 221 at the distal end of the free section 22.
[0088] In one embodiment, both the connecting segment 21 and the free segment 22 are made of polyethylene terephthalate (PET), with the connecting segment 21 being a woven structure and the free segment 22 being a knitted structure. Knitted fabrics inherently possess extensibility and resilience. Extensibility refers to the ability of a knitted fabric to elongate under external stretching; resilience refers to the ability of a knitted fabric to return to its original size after the external force is removed. Figure 27 The structure of the woven fabric is shown. Figure 28 This illustrates a knitted fabric structure.
[0089] like Figure 27 As shown, because the woven structure is formed by the warp and weft yarns overlapping and interlacing one above the other, the warp and weft yarns do not bend within the fabric structure, and there is no deformation in the transverse or longitudinal direction. Therefore, the woven fabric has relatively low elongation and resilience. Figure 28 As shown, the knitted yarns are formed by interlocking loops, and since loops are easily deformed, the knitted structure has greater extensibility and resilience. The free segment uses a knitted structure, giving it extensibility and resilience. On one hand, when the occlusion stent is subjected to pressure from the main chest stent, the knitted structure is softer than the woven structure, and the woven structure of connecting segment 21 and the knitted structure of free segment 22 are separate membranes connected by connecting elements. This prevents the free segment from being affected by the tendency of the two membranes of the connecting segment to move away from each other (firstly, the tendency of the two membranes of the free segment to move away from each other is not easily transmitted towards the free segment; secondly, the connecting elements have the function of blocking the transmission of this tendency), thus ensuring the stability of the lateral opening closure state at the distal end of the free segment. On the other hand, the lateral dimension of the distal part of the free segment can be made smaller, resulting in a smaller opening when the lateral opening at the distal end of the free segment is open, while also ensuring smooth retraction of the sheath core.
[0090] The first free diaphragm 205 and the second free diaphragm 206 of the free segment 22 can be formed by weft knitting, giving the free segment stretch and resilience in the transverse direction. Weft knitting uses one or more yarns to form loops (continuous loops) sequentially along the transverse direction (weft) of the fabric surface, such as... Figure 28 As shown. When using weft knitting, when the membrane of the free section 22 is connected to the connecting section 21, the coil structure in the weft knitting structure is set in the transverse direction to ensure that the transverse extension of the free section is greater than the axial extension.
[0091] In other embodiments, the diaphragm of the free segment 22 can also be woven using knitting methods other than weft knitting, as long as the free segment has stretch and resilience in the lateral direction. Alternatively, the lateral stretch of the free segment can be greater than its axial stretch, and it can also have lateral resilience.
[0092] In other implementations, such as Figure 29 As shown, the free segment may further include a connecting portion 22a and a constricted portion 22b. The proximal end of the connecting portion 22a is connected to the distal end of the connecting segment 21. The lateral width of the constricted portion 22b is smaller than the lateral width of the connecting portion 22a. Since the free segment 22 has extensibility and resilience in the lateral direction, the circumferential dimension of the distal portion of the free segment 22 (the constricted portion 22b) can be set to be smaller than the circumference at the maximum lateral dimension of the tip head. That is, a constricted structure is set at the distal end of the free segment to make the lateral opening at the distal end of the free segment smaller, while also ensuring that the sheath core can be smoothly retracted. The circumference of the constricted portion 22b can be set to 50% to 70% of the circumference at the maximum lateral dimension of the tip head, which can ensure the constriction effect while facilitating the retraction of the sheath core. If the constricted portion 22b is too small, it will be difficult for the sheath core to retract, or it will cause excessive lateral deformation of the constricted portion 22b, which will be difficult to rebound to the original size; if the constricted portion 22b is too large, the constriction effect may be insignificant.
[0093] In other embodiments, the connecting segment 21 and the free segment 22 are sutured together circumferentially by a suture line, so that the connecting segment and the free segment are interconnected axially.
[0094] Since the free section 22 is a knitted structure, the knitted fabric itself also has curling properties; curling property refers to the property of the edge of the knitted fabric to curl in its natural state; this is because the yarn is bent during the looping process, and its elasticity tries to straighten it again, and the bending yarn in the edge loop will 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 connecting segment, such as... Figure 25-26As shown, the axial stitching of the distal ends of the first free membrane 205 and the second free membrane 206 together can suppress the curling of the knitted fabric edge to a certain extent, prevent the distal edges of the two free membranes (with their reverse sides facing each other) from curling outwards, and avoid the situation where the closure of the lateral opening at the distal end 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 their adjacent edges in the axial direction. In other embodiments, such as... Figure 30 As shown, the first and second free membranes are opposite each other and are not completely connected at their adjacent edges in the axial direction to form a connecting segment 220 (partial stitching). The axial edges of the proximal portions 220a of the first and second free membranes are connected, while the distal portions 220b are not connected along the axial direction to form a free roll. In its natural state, the edges of weft-knitted plain knit fabrics have obvious curling phenomena. The curling directions of the weft-knitted plain knit fabric structure are different in the transverse and longitudinal (axial) directions. Along the longitudinal (axial) direction of the loop, its edges (such as...) Figure 28 The left and right edges of the loop curl toward the reverse side (back side) of the fabric; along the transverse direction of the loop, its edges ( Figure 28 The top and bottom edges of the fabric curl towards the front side. Taking a weft-knitted plain weave as an example, such as... Figure 30 As shown, both the first and second free diaphragms include a front and a back side; in one embodiment, the continuous coil of the first and second free diaphragms ( Figure 28 The transverse portion of the occlusion support extends along the axial direction of the vertical occlusion support. The front surfaces of the first free diaphragm 205 and the second free diaphragm 206 face the same direction and are sewn together to form a free segment that connects the proximal and distal ends. Figure 31 As shown, the reverse side of the first free diaphragm 205 and the front side of the second free diaphragm 206 both face the inner side of the free segment. Due to the transverse direction of the coil extension, their edge coils curl towards the front side of the fabric. That is, the distal ends of the first free diaphragm 205 and the second free diaphragm 206 both have a curled edge in the same direction. Figure 31 As shown, the first free membrane 205 and the second free membrane 206, Figure 31 Each of these membranes has its left side as the front and its right side as the back. The front sides of both the first free diaphragm 205 and the second free diaphragm 206 face to the left in the diagram. Adjacent edges are not fully connected to form a connecting segment 220, meaning the back of the first free diaphragm 205 faces the front of the second free diaphragm 206. In this case, the free roll portions of both the first and second free diaphragms 205 and 206 face the left-hand roll edge. In other embodiments, such as... Figure 32As shown, the front side of the first free diaphragm 205 and the back side of the second free diaphragm 206 both face the inside of the free section. Therefore, the free rolled portions of the first free diaphragm 205 and the second free diaphragm 206 both face the right-side rolled edge.
[0097] In other implementations, such as Figure 33 As shown, the continuous coil (transverse) of the first free diaphragm 205 and the second free diaphragm 206 extends along the axial direction of the vertical sealing support. The front surfaces of the first free diaphragm 205 and the second free diaphragm 206 are fitted together, and their edges are sewn together to form a free segment that extends from the proximal end to the distal end. That is, the front surfaces of the first free diaphragm 205 and the second free diaphragm 206 face each other towards the inside of the free segment 220. Figure 28 As shown laterally, its edge loops curl towards the front of the fabric, so the free rolled portions at the distal edges of the first free diaphragm 205 and the second free diaphragm 206 both have a curled edge property facing inward towards the free segment 220. For example... Figure 33 As shown, the first free membrane 205 is located to the left of the second free membrane 206. Figure 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 to the right of the first free diaphragm 205, with its left side being the front side and its right side being the back side. Since the axial edges of the proximal portions of the first free diaphragm 205 and the second free diaphragm 206 are connected, while the distal portions are not connected axially to form free rolls, meaning the distal portions of the free segment are not sewn together and do not inhibit the curling of the knitted fabric, the distal free rolls of the first free diaphragm 205 and the second free diaphragm 206 both face their respective front edges, thus improving the closure of the lateral opening at the distal end of the free segment. In other embodiments, the front sides of the first free diaphragm and the second free diaphragm both face the inside of the free segment. The distal end of the first free diaphragm can also extend beyond the distal end of the second free diaphragm (not shown), causing the free rolls of the first free diaphragm to tend to wrap around the free rolls of the second free diaphragm, further improving the closure of the lateral opening at the distal end of the free segment.
[0098] The present invention also provides an occlusion system, including a delivery device and an occlusion stent 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 enter from the distal end of the one-way valve member and exit from the proximal end. The sheath core assembly includes a sheath core and a tip head disposed proximal to the sheath core for guiding delivery. The sheath core assembly may further include a post-release structure, with a bare wave coil correspondingly disposed proximal to the occlusion stent, cooperating with the post-release structure to achieve post-release of the proximal end of the occlusion stent.
[0099] 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.
[0100] 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 connected with each other, the connected segment is connected to the covered stent in a circumferential direction away from one end of the free segment, and the one-way valve member is arranged in an axial direction at least two times; The occlusion stent comprises a developing member, the one-way valve member comprises a first one-way valve member and a second one-way valve member, a distal end of the connected segment of the first one-way valve member is in a strip shape, the strip shape comprises a first long axis and a first short axis, and an axial cross section defined by the two ends of the first long axis is a first cross section; The developing member comprises a first developing member and a second developing member, the first developing member and the second developing member are on the same radial cross section diameter of the covered stent, and an included angle between a connecting line of developing points of the first developing member and the second developing member and the first cross section is in a range of [0°, 45°], so that a direction of a connecting line L5 of the released occlusion stent is perpendicular to or deviates from a direction of a radial extrusion force of a thoracic main stent, and an extension direction of the connecting line L5 is the same as an extension direction of a long axis of a distal end of the strip shape.
2. The occlusion stent of claim 1, wherein, The free segment is in a shape of an ellipse or a strip shape at one end close to the connected segment.
3. The occlusion stent of claim 1, wherein, The one-way valve member comprises at least two membrane pieces, adjacent edges of the at least two membrane pieces are connected with each other to form an axisymmetric structure of a funnel type structure.
4. The occlusion stent of claim 1, wherein, An axial projection length of the first developing member on a vertical plane of the first cross section is greater than an axial projection length of the second developing member on the vertical plane of the first cross section, and a transverse projection length of the second developing member is greater than a transverse projection length of the first developing member.
5. The occlusion stent of claim 1, wherein, The first developing member and the second developing member are symmetrically arranged on the occlusion stent.
6. The occlusion stent of claim 1, wherein, The first developing member is arranged on the covered stent, and the second developing member is arranged on the one-way valve member.
7. The occlusion stent of claim 1, wherein, The one-way valve member comprises at least two membrane pieces, adjacent edges of the at least two membrane pieces are connected with each other to form a funnel type structure, the funnel type structure comprises a wide part and a narrow part, the wide part is a connected segment, the narrow part is a free segment, 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.
8. An occlusion system, 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 connected with each other, the connected segment is connected to the covered stent in a circumferential direction away from one end of the free segment, and the one-way valve member is arranged in an axial direction at least two times;
Citation Information
Patent Citations
Plugging support and plugging system
CN119791901A