Lumen stent
By employing a flared distal end structure, a contrast element design, and a keel-wound braided wire in the iliac vein stent, the problems of distal end shortening and braided wire unwinding were solved, thus improving the stability and safety of the stent.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- LIFETECH SCI (SHENZHEN) CO LTD
- Filing Date
- 2024-12-26
- Publication Date
- 2026-06-09
AI Technical Summary
Existing iliac vein stents are prone to shortening at the distal end during deployment, and the braided wire tail is highly likely to unwind, causing the stent to bounce within the blood vessel and irritate the vessel wall.
A tubular support was designed, which adopts a flared distal end structure and a developing element design. Combined with a keel structure, the braided wire tail is wrapped around the keel and fixed through the developing hole to reduce the possibility of the braided wire tail unwinding.
It effectively reduces the possibility of the braided wire tail unwinding, reduces the bouncing of the stent in the blood vessel and the stimulation of the blood vessel wall, and improves the stability and safety of the stent.
Smart Images

Figure CN224331084U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical devices, and in particular to a lumen stent. Background Technology
[0002] Iliac vein compression syndrome (IVCS) refers to the compression of the left common iliac vein by the right common iliac artery anteriorly and the lumbar spine and lumbosacral joint posteriorly before it joins the inferior vena cava. This prolonged compression of the venous wall and the formation of intravascular adhesions lead to impaired venous return in the lower extremities and pelvis. Compared to arteries, iliac veins are more tortuous, have a flatter lumen, and their size is easily affected by factors such as blood volume and respiration. Furthermore, iliac vein diseases are more difficult to measure in terms of size and degree of stenosis under single-angle DSA angiography.
[0003] Iliac vein stenting has a high technical success rate and good mid-to-long-term patency rate for intravascular coagulation (IVCS), especially for IVCS without deep vein thrombosis (DVT), making it the preferred treatment method for IVCS. For IVCS with DVT, stenting helps reduce thrombosis recurrence, improve mid-to-long-term patency rate, and reduce the incidence of post-thrombotic syndrome (PTS).
[0004] Commercially available iliac vein stents are generally divided into braided stents and laser-engraved stents. Braided stents offer better flexibility and fatigue resistance compared to laser-engraved stents, but are prone to shortening. Laser-engraved stents provide strong support and are less prone to shortening, but are more susceptible to breakage and unsuitable for long lesions. Each type has its advantages. For hook-type braided stents, while they offer good bending performance, during deployment, the proximal end of adjacent loops adheres to the vessel wall. When the distal end of the sheath is deployed, a bouncing force towards the proximal end can easily occur, leading to shortening of the distal end of the stent. Utility Model Content
[0005] At least one technical problem that this invention solves is how to reduce the possibility of the braided wire tail section of the lumen support unwinding.
[0006] This utility model provides a lumen stent, which is formed by braiding filaments. The lumen stent includes a tubular body and a first segment. The first segment is located at the distal end of the tubular body and is flared. The first segment includes a connecting end and a free end. The connecting end is connected to the tubular body. The braiding filaments include a first tail segment, which is wound around the same braiding filament or another braiding filament. The first tail segment includes an end, and the outer diameter at the end is larger than the filament diameter at other parts of the first tail segment.
[0007] In one embodiment, the tubular body includes a plurality of annular corrugated coils arranged along the axial direction, and two adjacent annular corrugated coils are connected by hooks. The lumen support includes at least one keel, which is spirally arranged around the axial direction on the lumen support.
[0008] In one embodiment, the keel and the braided wire are an integral structure, the at least one keel includes a first keel and a second keel, the lumen support includes a plurality of wave rods from the proximal end to the distal end, the second keel is spirally wound around the adjacent wave rod around the axial direction of the lumen support, thereby forming a gap with the wave rod, and the tail end of the first keel is folded back and passes through at least one of the gaps.
[0009] In one embodiment, the number of keels is one, and it is an integral structure with the braided wire, with the tail end of the keel folded back from the first section to the tubular body.
[0010] In one embodiment, the annular waveband includes a crest, a trough, and a wave rod, the wave rod extending between the crest and the trough, the keel spirally wrapping around the wave rod at least one turn and forming a gap with the wave rod, the tail end of the keel passing through the gap.
[0011] In one embodiment, the tail end of the keel includes an end segment and a sub-tail segment, wherein the radial dimension of the end segment is greater than the radial dimension of the sub-tail segment.
[0012] In one embodiment, the keel includes a first keel and a second keel spaced circumferentially, wherein the tail end of the first keel is folded back from the proximal or distal end of the lumen support and extends circumferentially across the second keel; and / or the tail end of the second keel is folded back from the proximal or distal end of the lumen support and extends circumferentially across the first keel.
[0013] In one embodiment, the first segment expands outward from the proximal end to the distal end and then extends straight. The tubular body includes a plurality of annular waverings arranged along the axial direction. The wave height of the low wave of the first segment is greater than the wave height of any of the annular waverings.
[0014] And / or the lumen stent includes a second segment located at the proximal end of the lumen stent, the second segment extending outward from the distal end to the proximal end and then straightening, the tubular body including a plurality of axially arranged annular corrugations, the wave height of the low wave of the second segment being greater than the wave height of any of the annular corrugations.
[0015] In one embodiment, the distal end of the lumen stent includes a first developing element, and the high wave on the distal end side of the lumen stent includes a first wave rod and a second wave rod. The first wave rod and the second wave rod cross at the distal end of the lumen stent and are smoothly connected to form a developing hole. The first developing element is wound around the circumference of the developing hole.
[0016] And / or, the proximal end of the lumen stent includes a second imaging element, the second segment includes a second annular end wave, the high wave of the second annular end wave includes a third wave rod and a fourth wave rod, the third wave rod and the fourth wave rod cross at the proximal end of the lumen stent and are smoothly connected to form another imaging hole, and the second imaging element is wound around the circumference of the other imaging hole.
[0017] In one embodiment, the lumen support is woven from at least one braided filament, the lumen support includes a first annular end corrugation, the keel includes a first keel segment, the first annular end corrugation is formed circumferentially by the braided filament, the first keel segment is wound around one of the corrugations of the first annular end corrugation, and the first annular end corrugation and the first keel segment are the portions adjacent to the braided filament.
[0018] In one embodiment, the lumen support includes another braided filament, the tubular body includes a first annular body corrugation from the distal end to the proximal end, the first segment is hooked and connected to the first annular end corrugation, the keel includes a second keel segment, and another braided filament is wound around a corrugation bar of the first annular body corrugation to form the second keel segment, the first annular body corrugation and the second keel segment being the adjacent portions of the other braided filament.
[0019] In one embodiment, the first segment includes a high wave and a low wave along the circumferential direction, wherein the waveform inflection point of the high wave at the free end and the waveform inflection point of the low wave at the free end are not on the same radial section.
[0020] One technical effect of one embodiment of this utility model is that it provides a tubular support such that the outer diameter at the end of the first tail section is larger than the wire diameter at other parts of the first tail section, thereby reducing the possibility of the braided wire tail section unwinding. Attached Figure Description
[0021] Figure 1 This is a schematic diagram of the structure of a lumen support provided in one embodiment of this application;
[0022] Figure 2 A schematic diagram of a lumen support provided in another embodiment of this application, cut along the axial direction and laid flat on the paper;
[0023] Figure 3A partially enlarged view of the first imaging element of the lumen stent provided in one embodiment of this application;
[0024] Figure 4 A partially enlarged view of the second imaging element of the lumen support provided in one embodiment of this application;
[0025] Figure 5 A process diagram illustrating the braiding of the first segment of a tubular support using braided wires, provided in one embodiment of this application;
[0026] Figure 6 A process diagram illustrating the process of weaving a second annular main body wavering using a braiding filament and weaving a first annular main body wavering using another braiding filament, according to one embodiment of this application.
[0027] Figure 7 for Figure 1 Enlarged view of point A in the middle;
[0028] Figure 8 for Figure 5 Enlarged view of point B in the middle;
[0029] Figure 9 A partial view of the first tail section of the lumen support provided in one embodiment of this application being inserted into the gap K;
[0030] Figure 10 A partial view of the end of the first tail section of the lumen support provided in one embodiment of this application, which is inserted into the gap formed by the hooking of the crest and trough of the adjacent wave ring.
[0031] Figure 11 for Figure 10 A partial schematic diagram of the first tail segment detached from the middle;
[0032] Figure 12 A schematic diagram showing the first and second keels of the lumen support provided in one embodiment of this application being connected at the first segment;
[0033] Figure 13 This is a partial structural schematic diagram of a support system provided in one embodiment of the present application;
[0034] Figure 14 This is a partial structural schematic diagram of a conveyor provided in one embodiment of the present application;
[0035] Figure 15 for Figure 13 Enlarged view of the distal end of the stent in the central lumen;
[0036] Figure 16 for Figure 15 The right view.
[0037] 10. Tubular support; 10a. Annular wavering; 11. First segment; 11a. First annular wavering; 111. Connecting end; 112. Free end; 113. High wave; 1131. First wave rod; 1132. Second wave rod; 114. Low wave; 115. A circular hole; 116. Climbing wave rod; 12. Tubular body; 121. First annular body wavering; 122. Second annular body wavering; 13. Second segment; 13a. Second annular wavering; 131. Third wave rod; 132. Fourth wave rod; 133. Another circular hole; K. Gap;
[0038] 14. First developed piece; 15. Second developed piece;
[0039] 16. Keel; 161. First Keel; 161a. First Keel Segment; 162. Second Keel; 162a. Second Keel Segment; 162b. Third Keel Segment; 163. First Tail Segment; 164. Second Tail Segment; 17. Transition Wave Circle; Detailed Implementation
[0040] To facilitate understanding of this utility model, a more complete description will be given below with reference to the accompanying drawings. The drawings illustrate preferred embodiments of this utility model. However, this utility model can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of the disclosure of this utility model.
[0041] 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.
[0042] To more accurately describe the structural features and application characteristics of this utility model, the terms "proximal end" and "distal end" are used as directional terms to describe the stent. "Proximal end" indicates the end of the stent closer to the heart after implantation, and "distal end" indicates the end of the stent farther from the heart after implantation. In the field of interventional medical devices, for the delivery device used to deliver the medical device when implanting it into a human or animal, the end closer to the operator is generally defined as the "proximal end," and the end farther from the operator is defined as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of the delivery device are defined.
[0043] This invention provides a tubular stent 10 in the form of a mesh tube. The tubular stent 10 can be woven from one, two, or more braided filaments. Taking two braided filaments as an example, ... Figure 1-2As shown, the lumen stent 10 is woven from two braided filaments. The lumen stent 10 includes a first segment 11, a tubular body 12, and a second segment 13 from the distal end to the proximal end. The first segment 11 is connected to the distal end of the tubular body 12 so that the first segment 11 is located on the distal end side of the lumen stent 10. The second segment 13 is connected to the proximal end of the tubular body 12 so that the second segment 13 is located on the proximal end side of the lumen stent 10.
[0044] The tubular body 12 includes a plurality of annular corrugated coils 10a arranged along the axial direction. Adjacent annular corrugated coils 10a are connected by hooks. The diameters of adjacent annular corrugated coils can be the same or different, allowing the tubular body 12 to be either cylindrical or frustoconical; no limitation is made here. Figure 1-2 As shown, the annular wave 10a has a structure that approximates a ring-shaped sine wave structure. The annular wave 10a includes multiple peaks and troughs, and the peaks and troughs are alternately arranged. The peak of the lower annular wave is hooked and intersected with the trough of the upper annular wave that is axially adjacent to it, so that two adjacent annular waves 10a are hooked and connected. In this way, multiple annular waves 10a are hooked and connected to each other, and the tubular body 12 formed by the final connection is a mesh structure.
[0045] In one embodiment, both the first segment 11 and the second segment 13 are flared. The first segment 11 and the second segment 13 are hooked and connected to the tubular body 12. The first segment 11 includes a connecting end 111 and a free end 112. The connecting end 111 of the first segment 11 is connected to the tubular body 12. The first segment 11 includes a high-wave 113 and a low-wave 114 along its circumference. The waveform inflection point of the high-wave 113 at the free end 112 and the waveform inflection point of the low-wave 114 at the free end 112 are not on the same radial section. The waveform inflection points of the high-wave 113 and the low-wave 114 at the free end 112 are spaced apart, i.e., the high-wave 113 and the low-wave 114 are spaced apart. Figure 1As shown, the waveform inflection point of the high wave 113 at the free end 112 is closer to the distal end than the waveform inflection point of the low wave 114 at the free segment. Since the lumen support 10 has a hook-and-loop structure, it needs to be radially compressed and loaded into the sheath for easy delivery to the target location. Then, the lumen support 10 is released from the sheath. At this time, the second segment 13 at the proximal end of the lumen support 10 is released first, followed by the tubular body 12 and the first segment 11 at the distal end. Because the first segment 11 at the distal end has a flared structure, when the sheath is retracted… At the first segment 11, the stent 10 has a high-low wave structure at the distal end, with high wave 113 and low wave 114 spaced apart. This allows low wave 114 to deploy first, followed by high wave 113, during stent release. This reduces stent shortening caused by proximal bouncing due to a single deployment in the first segment 11, and further reduces radial force at the distal end, decreasing circumferential shear force and preventing excessive stimulation of the vessel wall at the distal end. This also prevents dissection or intimal hyperplasia at the first segment 11. Notably, the inflection point of high wave 113 at the free end 112 and the inflection point of low wave 114 at the free end 112 are not on the same radial section. Figure 1 Let's take an example to illustrate. Figure 1 In the diagram, the first segment 11 of the lumen support 10 is located at the bottom, and the second segment 13 of the lumen support 10 is located at the top. The inflection point of the high wave 113 at the free end 112 of the first segment 11 is the trough of the high wave 113, and the inflection point of the low wave 114 at the free end 112 is the trough of the low wave 114. Therefore, the inflection points of the high wave 113 and the low wave 114 at the free end 112 of the first segment 11 are not on the same radial section; that is, the troughs of the high wave 113 and the low wave 114 at the free end 112 of the first segment 11 are not on the same radial section. It can be understood that when... Figure 1 The lumen stent 10 is placed upside down, with the first segment 11 (distal end) of the lumen stent 10 located above the figure and the second segment 13 of the lumen stent 10 located below the figure. Then, the waveform inflection point of the high wave at the free end of the first segment is the peak of the high wave, and the waveform inflection point of the low wave at the free end of the first segment is the peak of the low wave. Therefore, the waveform inflection points of the high wave and the low wave at the free end of the first segment are not on the same radial section, that is, the peak of the high wave and the peak of the low wave at the free end of the first segment are not on the same radial section.
[0046] In one implementation, such as Figure 1-2As shown, the first segment 11 gradually moves away from the central axis of the tubular body 12 from its proximal end to its distal end, causing the first segment 11 to tilt outward relative to the central axis of the tubular body 12, thus making the circumferential surface of the first segment 11 frustum-shaped from its distal end to its proximal end. The degree of conicity of this frustum-shaped shape is represented by the angle α between the inclined plane line L1 of the first segment 11 along the axial direction and the axial line L of the tubular body 12. The larger the angle α, the greater the opening degree of the distal end of the first segment 11, given a fixed axial length. Taking the cross-section of the first segment through the central axis as a quasi-isosceles trapezoid as an example, the inclined plane line here is the straight line containing the legs of the isosceles trapezoid, such as... Figure 2 As shown, the degree of conicity α of the frustum satisfies: 0°<α≤80°. The larger the opening and the larger the angle, the better the adhesion to the wall. Improved adhesion can reduce the possibility of abnormal vascular enlargement. The second segment 13 gradually moves away from the central axis of the tubular body 12 from its distal end to its proximal end, so that the second segment 13 is inclined outward relative to the central axis of the tubular body 12, thus making the circumferential surface of the second segment 13 form an inverted frustum shape from the proximal end to the distal end. The degree of conicity of this inverted frustum shape is represented by the angle β between the inclined plane line L2 of the second segment 13 along the axial direction and the axial line L of the tubular body 12. The larger the angle β, the greater the opening degree of the proximal end of the second segment 13, given a fixed axial length. Taking the cross-section of the second segment through the central axis as an isosceles trapezoid as an example, the inclined plane line here is the straight line containing the waist of the isosceles trapezoid, such as... Figure 2 As shown, the cone-shaped degree β of the inverted cone-shaped platform satisfies: 0°<β≤80°. The second segment 13 can be set as a funnel-shaped structure symmetrical to the first segment 11. The second segment 13 is located at the proximal end of the iliac vein stent. Setting the second segment 13 as a funnel-shaped structure can match the diameter change of the opening of the blood vessel. Furthermore, setting the second segment 13 as the same high and low wave structure as the first segment 11 can reduce the interference to the blood flow of the other branch.
[0047] In other embodiments, the first segment 11 expands outward from the proximal end to the distal end and then extends straight along the axial direction, and the second segment 13 expands outward from the distal end to the proximal end and then extends straight along the axial direction. The low wave 114 of the first segment 11 has a higher wave height than any annular wave of the tubular body 12, thereby making the radial force of the first segment 11 less than the radial force of the tubular body 12, reducing the stimulation of blood vessels by the flared structure of the first segment 11. It can be understood that the low wave 114 of the second segment 13 has a higher wave height than any annular wave of the tubular body 12, thereby making the radial force of the second segment 13 less than the radial force of the tubular body 12. In one embodiment, when the multiple annular wave loops in the tubular body 12 are of equal height, the low wave 114 of the first segment 11 has a higher wave height than the annular wave loop of the tubular body 12, and the low wave 13 has a higher wave height than the annular wave loop of the tubular body 12. When the multiple annular wave loops in the tubular body 12 are of non-equal height, the low wave 114 of the first segment 11 has a higher wave height than the maximum wave height in the annular wave loop of the tubular body 12, and the low wave 114 of the second segment 13 has a higher wave height than the maximum wave height in the annular wave loop of the tubular body 12. This can make the radial support force at both ends of the luminal stent 10 less than the radial support force of the tubular body 12, thereby reducing the stimulation of the blood vessels at the ends.
[0048] like Figure 1-2 Combination Figure 3 As shown, a developing element is provided at the distal end and / or proximal end of the lumen stent 10. The distal end of the lumen stent 10 includes a first developing element 14. The first segment 11 includes a first annular end wave 11a, which is located on the distal end side of the lumen stent. The high wave 113 of the first annular end wave 11a includes a first wave rod 1131 and a second wave rod 1132. The first wave rod 1131 and the second wave rod 1132 cross at the distal end of the lumen stent 10 and are smoothly connected to form a developing hole 115. The first developing element 14 is a developing wire. The first developing element 14 is circumferentially wound around the braided wire that forms the developing hole 115, so that the end of the free end 112 of the first segment 11 is provided with a developing structure to indicate the position of the distal end of the lumen stent 10.
[0049] like Figure 1-2 Combination Figure 4As shown, the proximal end of the lumen stent 10 includes a second developing element 15, and the second segment 13 includes a second annular end wave 13a. The second annular end wave 13a is located on the proximal side of the lumen stent. The high wave of the second annular end wave 13a includes a third wave rod 131 and a fourth wave rod 132. The third wave rod 131 and the fourth wave rod 132 cross at the proximal end of the lumen stent 10 and are smoothly connected to form another developing hole 133. The second developing element 15 is configured as a developing wire. The second developing element 15 is circumferentially wound around the braided wire that forms the other developing hole 133, so that the proximal end of the second segment 13 is provided with a developing structure to indicate the position of the proximal end of the lumen stent 10. During the release of the lumen stent 10, it is easy to position and release. Furthermore, since the developing wire is circumferentially wound around the braided wire that forms the developing hole, the second developing element 15 is annular in shape, which has clearer developing properties compared to the general "V" shaped developing structure.
[0050] Furthermore, such as Figure 3-4 As shown, after the imaging wire of the first imaging element 14 is circumferentially wound around the braided wire forming the imaging hole at the distal end, the two ends of the imaging wire are tied across the intersection to fix the imaging wire, thus avoiding problems such as the imaging element falling off or shifting; after the imaging wire of the second imaging element 15 is circumferentially wound around the braided wire forming the imaging hole at the proximal end, the two ends of the imaging wire are tied across the intersection to fix the imaging wire, thus avoiding problems such as the imaging element falling off or shifting. This avoids the surgical risk caused by inaccurate positioning of the lumen stent 10 during initial release (the proximal end of the lumen stent 10 is released first) leading to displacement of the lumen stent 10.
[0051] In one embodiment, both the first developing element 14 and the second developing element 15 can be configured as developing wires. Taking the developing wire of the first developing element 14 as an example, Figure 3 As shown, the two ends of the developing wire can be tied laterally (perpendicular to the axial direction) across the intersection to secure the developing wire. In other embodiments, such as Figure 4 As shown, the two ends of the developing wire can also be knotted across the intersection along the axial direction to fix the developing wire. When the lumen support 10 is radially compressed, the intersection deforms with the compression, so the position where the developing wire crosses the intersection will not loosen relative to the wave rod, thus affecting the recovery of the wave rod at the corresponding position.
[0052] Furthermore, the ends of the imaging wire are rounded to prevent scratching or damaging blood vessels, reduce vascular stimulation, and avoid problems such as dissection or abnormal intimal hyperplasia caused by excessive stimulation.
[0053] The lumen support 10 also includes at least one keel 16, which is spirally arranged around the axial direction on the lumen support 10. The keel 16 can be a spiral metal wire, spirally arranged around the axial direction on the lumen support 10. The central axis of the keel spiral coincides with the central axis of the tubular body 12. One, two or more keels can be provided. Increasing the number of keels can improve the radial support force of the lumen support 10. In one embodiment, there are two keels, including a first keel 161 and a second keel 162. The lumen support 10 is woven from two braided wires. The first segment 11, the tubular body 12, the second segment 13, the first keel 161, and the second keel 162 of the lumen support 10 are all woven from two braided wires in one piece, so that the keel and the braided wires are an integral structure. In the process of weaving a ring-shaped wave, the keel segment is formed at the corresponding position of the ring-shaped wave. Multiple keel segments are connected along the wave rods of adjacent ring-shaped waves to form the keel. The two braided wires can be woven from the proximal end to the distal end at the same time, or from the distal end to the proximal end at the same time, or one can be woven from the proximal end to the distal end and the other from the distal end to the proximal end. There is no limitation here. In other embodiments, the number of keels can also be set to one, and the keel and the braiding yarn of the braiding body are integrated into one structure. The tail end of the keel is folded back from the first section to the tubular body, which can reduce the possibility of the braiding support unspinning due to the bounce of the distal end.
[0054] like Figure 5-9 As shown, the process of braiding the lumen support 10 requires the use of a mold 20 with a mandrel. The mandrel is inserted into the mold 20, which facilitates the braiding wires to wrap around the mandrel circumferentially to form crests, troughs, or development holes. The mold 20 is cylindrical to facilitate observation of the direction of the braiding wires. Figure 5-6 This is a schematic diagram showing the mold being cut axially and laid flat on paper. The following example illustrates how the lumen stent 10 is woven into the mold 20 using two braided wires, with both braided wires braided from the distal end to the proximal end (in other braiding methods, braiding can also be done from the proximal end to the distal end).
[0055] like Figure 5 and Figure 8 Combination Figure 1-2As shown, a braided filament M first leaves a small section and starts weaving from a mold rod Q (one of the second layer mold rods) at the distal end as the starting point. At the starting point, a low wave 114 of the first segment 11 is finally formed, and it extends obliquely to the upper left to another mold rod T in the third layer to form the peak of the low wave 114. When the braided filament extends obliquely between the two mold rods, it forms a climbing wave rod 116. Then, it weaves one or two or more times in the circumferential direction back to the mold rod Q at the starting point to form a first annular end wave loop 11a (first segment 11) with high and low waves. When it weaves to the mold rod S at the trough of the high wave 113 of the first segment 11, it wraps around the mold rod in the opposite direction to form a developing hole 115, thereby forming the weaving position of the first developing element 14, which makes it easy for the first developing element 14 to be wound and fixed around the braided filament that forms the developing hole in the circumferential direction.
[0056] Then, when the braided filament weaves around the mold circumference once or twice or more and returns to the starting point at the mold rod Q, it continues to wind along the climbing wave rod 116 from the starting point to form the first keel segment 161a of the first keel 161. Then, it continues to extend obliquely upwards between the fourth and fifth mold rods counting from the distal end to the proximal end, thus forming the second annular main body wave 122 of the tubular main body 12 from the distal end. This process is repeated, and at the points where the braided filament repeatedly travels in the helical direction around the axial direction, a continuous but discontinuous first keel 161 is formed. When the braided filament passes through a second time, it winds around the climbing wave rod formed the first time, thus forming the keel segment of the first keel 161. Figure 5-6 As shown, when the first annular end wave 11a is formed, the keel segment is formed by the same braiding filament passing through the same path twice and winding around it. The braiding filament forms a climbing wave bar of another braiding filament at the position of the first annular main wave 121. When the other braiding filament weaves the first main annular wave 121 in the circumferential direction, it winds around the climbing wave bar formed by the previous braiding filament, forming the keel segment of the first keel 161 in the first annular main wave 121.
[0057] Another braided yarn N is reserved for a small section. Starting from the trough of another low wave in the first annular end wave 11a, the mold rod P is wound around the corresponding low wave rod (the climbing wave rod formed by the previous braided yarn in the first annular end wave 11a) to form a keel segment of the second keel 162. Then, weaving begins between the third and fourth mold rods, thereby forming the first annular body wave 121 of the tubular body 12 from the distal end. The trough of the distal end of the first annular body wave 121 of the tubular body 12 is proximal to the first annular end wave 11a. The crests of the ends are hooked one by one, and the crests of the proximal end of the first annular body wave 121 of the tubular body 12 are hooked one by one with the troughs of the distal end of the second annular body wave 122 of the tubular body 12. And so on. When the same or different braided wires repeatedly pass through the same path at the interval position of the other braided wire N in the same spiral direction as the first keel 161, a continuous but discontinuous second keel 162 can be formed. When the braided wire passes through for the second time, it wraps around the climbing wave rod formed in the first time, thus forming a keel segment of the second keel 162.
[0058] When the keel segments of the first keel 161 and the second keel 162 are wound around the corresponding climbing wave rods, the braided wires are wound around the climbing wave rods at least once in the circumferential direction. When the braided wires forming the keel segments of the first keel 161 and the second keel 162 are wound around the climbing wave rods, the keel segments and the climbing wave rods are twisted into a spiral shape, which can restrict the relative sliding between the keel segments and the wound climbing wave rods along the axial direction, increase the integrity of the keel segments and the annular wave rings at their corresponding positions, thereby increasing the keel's ability to prevent axial shortening and further reducing the lumen size. The axial shortening of the stent 10 refers not only to the axial support force brought about by the axial extension of the keel, which can reduce the shortening caused by the relative axial displacement caused by the bouncing force released by the stent between the interlocking annular corrugations, but also, most importantly, the instantaneous bouncing force. Due to the keel segment wrapping around and clinging to the corrugation rod, the keel segment and the corresponding annular corrugation at the same position are integrated, so that the keel segment can unload the bouncing force brought by the bouncing annular corrugation, thereby reducing the axial shortening caused by the bouncing force when the lumen stent 10 releases the distal end.
[0059] The lumen stent 10 is made of at least one braided filament, and may be made of one, two, or more braided filaments. In one embodiment, the lumen stent is made of two braided filaments. Figure 5-6 Combination Figure 1 and Figure 7As shown, the lumen stent 10 includes a first annular end corrugation 11a, and a keel including a first keel segment 161a. The first annular end corrugation 11a is formed circumferentially by braided wires. The first keel segment 161a is wound around one of the corrugations of the first annular end corrugation 11a. The first annular end corrugation 11a and the first keel segment 161a are adjacent to each other by braided wires. Alternatively, the lumen stent 10 includes another braided wire. The tubular body 12 includes a first annular body corrugation 121 at the distal end. The first annular body corrugation 121 is hooked and connected to the first annular end corrugation 11a. The second keel 162 includes a second keel segment 162a and a third keel segment 162b, and another braided wire is wound around it. A wave rod of the first annular main wave ring 121 (the keel segment 162a and the first annular main wave ring 121 are made of the same braided yarn) forms the second keel segment 162a. The first annular main wave ring 121 and the second keel segment 162a are adjacent parts of another braided yarn. Another braided yarn N wraps around a wave rod of the second annular main wave ring 122 (the keel segment 162b and the second annular main wave ring 122 are made of different braided yarns) to form the third keel segment 162b. When the third keel segment 162b wraps around the climbing wave rod at the corresponding position on the second annular main wave ring 122, it wraps around the climbing wave rod at least once in the circumferential direction, thereby forming a gap at the wave rod for the end of the first tail segment 163 to pass through. Since the keel segment and its corresponding wave ring or adjacent wave ring are adjacent parts, when the keel segment unwinds, it may cause local deformation of the wave ring itself of the lumen support 10. In one embodiment, when the keel segments of the first keel 161 and the second keel 162 are wound around the corresponding climbing wave bar, they are wound at least one turn in the circumferential direction, thereby forming a gap at the wave bar. The tail of the braided filament extends to the gap, which can be used for the ends of the first tail segment 163 and the second tail segment 164 to pass through. A small section of a braided filament M is reserved at its distal end to form the first tail segment 163 of the first keel 161. The first tail segment 163 extends and winds along the wave bar at the corresponding position on the mold rod toward the second keel 162, and extends to the first keel segment of the second keel 162. The end of the first tail segment 163 passes through the gap K formed by the first keel segment of the second keel 162 and its corresponding climbing wave bar 116a, as shown. Figure 7 Combination Figure 9 As shown. When the braided yarn wraps around the climbing bar 116a at least once in the circumferential direction, the formation position of the gap K can be made to avoid the crest or trough of the wave. Since the gap is a gap that is neither a crest nor a trough, when the gap shortens in the axial direction of the support, the gap will not widen because the crests and troughs between adjacent waves are hooked together. This is in contrast to the case where the end of the first tail passes through the hole at the crest or trough position (such as...). Figure 10-11As shown, this can further increase the integration of the first tail section 163 with the lumen support 10, preventing the risk of unwinding at the end of the support braided wire. In other embodiments, the lumen support can also be woven from a single braided wire. When the first keel is wrapped around the corresponding position of the climbing wave rod, it is wrapped at least once in the circumferential direction, thereby forming a gap at the wave rod, and the end of the first tail section of the braided wire passes into the gap.
[0060] like Figure 1-2 Combination Figure 9As shown, the lumen stent 10 includes, from the distal end to the proximal end, a first annular end corrugation 11a, a first annular main body corrugation 121, and a second annular main body corrugation 122. The first annular end corrugation 11a is the corrugation of the first segment 11, and the first annular main body corrugation 121 and the second annular main body corrugation 122 are the corrugations of the tubular main body 12. The braided wire of the lumen stent also includes a first keel 161, a second keel 162, and a first tail segment 163. The first keel 161 and the second keel 162 are spirally wound in the same direction at intervals on the lumen stent 10. The first tail segment 163 is spiraled from one end of the first keel 161 in a direction opposite to the spiral direction of the first keel 161 and extends to the keel segment of the second keel 162 located at the position of the tubular main body 12. A first annular main corrugation and a second annular main corrugation 122 are hooked together to form multiple hooking points. After the second keel 162 passes through one of the hooking points from its distal end to its proximal end, the keel segment formed at the second annular main corrugation 122 wraps around the corresponding climbing corrugation 116a at least once, thus forming a gap K for the first tail segment 163 to pass through. When the first tail segment 163 extends along the corrugation 116a to near the second keel 162, its end is folded back into the gap (the folding back here means that the end of the braided yarn does not continue to spiral in the original spiral direction, but is folded in a direction deviating from its spiral direction). It can be understood that when the first tail segment 163 passes through the gap K, it can pass from the outside to the inside of the braided lumen support, so that the end of the first tail segment protrudes from the inside of the lumen support to maintain the flatness of the outer surface of the lumen support. Understandably, the lumen stent 10 also includes a second tail section 164, which is connected to the end of the second keel 162. The second tail section 164 passes through the gap formed when the keel section of the first keel 161 wraps around the climbing wave rod at the second annular main body wave ring 122. Similarly, the braided wire tail section of the lumen stent 10 at the proximal end can also be treated in the same way as the ends of the first tail section 163 and the second tail section 164, so that the end of each braided wire passes through the gap formed between the keel section and the climbing wave rod, further preventing the braided wire from unwinding. In one embodiment, the first segment 11 further includes a transition wave loop 17. The proximal end of the transition wave loop 17 is connected to the first annular main body wave loop 121, and the distal end of the transition wave loop 17 is connected to the first annular end wave loop 11a. The transition wave loop 17 is used to transition the partial inclination between the first segment 11 and the tubular main body 12. In this case, after the first tail segment 163 is wound around the transition wave loop 17, the end of the first tail segment 163 can be folded back and passed through the gap formed by the second keel 162 at the keel section on the first annular main body wave loop 121. Figure 2As shown; in other embodiments, the transition wavering 17 may not be included, and the end of the first tail section 163 may be folded back and passed through the gap formed at the keel section on the first annular main wavering 121 or the second annular main wavering 122 by the second keel 162. Whether the end of the first tail segment 163 extends to the first annular main body wavering 121 or to the second annular main body wavering 122 is not limited here. It is sufficient that the end of the first tail segment 163 extends to the tubular main body 12 so that it can be folded back into the gap formed by the second keel 162 at the keel section on the annular wavering of the tubular main body 12. The extension of the end of the first tail segment 163 into the gap formed by the second keel 162 at the keel section on the annular wavering of the tubular main body 12 can, on the one hand, allow the first tail segment 163 to avoid bouncing at the first segment 11 and reduce the possibility of unwinding; on the other hand, the first tail segment 163 connects to and supports the gap between the first keel 161 and the second keel 162, which helps to buffer the bouncing of the first tail segment 163 at the distal end of the tubular main body 12 and further prevent the first tail segment 163 from unwinding.
[0061] In other embodiments, the first tail segment 163 includes an end with an outer diameter larger than the diameter of the filaments at other parts of the first tail segment. This makes the end of the braided filament spherical, preventing the end from slipping out of the gap and further preventing the braided filaments from unwinding. This avoids local deformation of the lumen support 10 and prevents unwinding due to axial shortening, which could affect the basic performance of the lumen support 10. It is understood that as long as the outer diameter at the end is larger than the diameter of the filaments at other parts of the first tail segment, even if the end of the first tail segment does not penetrate the gap, if the first tail segment is wound around any thread of the braided filament, the larger diameter of the filament at the end limits the end of the braided filament to the thread of the braided filament, reducing the possibility of reverse unwinding and preventing the braided filaments from unwinding.
[0062] It is understandable that the first annular end corrugation 11a of the first segment 11 can be a single-layer corrugation where the corrugation bar does not overlap with each other in the circumferential direction. In this case, the braiding wire only needs to weave one revolution in the circumferential direction; or it can be a corrugation bar that weaves across crests / troughs in the circumferential direction, resulting in multiple corrugations that overlap and intersect in the circumferential direction. In this case, the braiding wire needs to weave at least two revolutions in the circumferential direction. Figure 1-2 As shown. Since the first annular end waveband 11a is configured as a multi-layered waveband with alternating high and low waves and overlapping wave rods, in order to form the structure of the first annular end waveband 11a with alternating high and low waves, the mold rod forming the first annular end waveband 11a is divided into three layers: upper, middle, and lower, as shown. Figure 5-6As shown, the upper layer mold rod (the third layer mold rod counting from the distal end to the proximal end) is used to form the crest of the first annular end corrugation 11a, the middle layer mold rod (the second layer mold rod counting from the distal end to the proximal end) is used to form the trough of the low wave 114 of the first annular end corrugation 11a, and the lower layer mold rod (the first layer mold rod counting from the distal end to the proximal end) is used to form the trough of the high wave 113 of the first annular end corrugation 11a. To form a structure where the wave rods of the first annular end corrugation 11a overlap, during the weaving process, when the braiding filament crosses from the middle layer mold rod to the upper layer mold rod, it skips at least one nearest upper layer mold rod. The number of mold rods in a layer, the circumferential spacing, and the axial spacing between adjacent layers of mold rods can be set according to the specifications of the required braided lumen support 10, and will not be elaborated further here.
[0063] The tubular support 10 woven by the above method can have the first keel 161 and the second keel 162 spiraled in the same direction or in opposite directions. When the first keel 161 and the second keel 162 spiral in the same direction, they are radially opposite each other in the circumferential direction. When the annular corrugations of the tubular body 12 are set to be uniform and of equal height, the first keel 161 and the second keel 162 can also be spirally parallel. When the first keel 161 and the second keel 162 spiral in opposite directions, they can form an intersection on the tubular body 12, which will not be elaborated here.
[0064] In other embodiments, the keel includes a first keel 161 and a second keel 162 spaced apart circumferentially, wherein the tail end of the first keel 161 is folded back from the proximal or distal end of the lumen support 10 and extends circumferentially across the second keel 162; and / or the tail end of the second keel 162 is folded back from the proximal or distal end of the lumen support 10 and extends circumferentially across the first keel 161.
[0065] Furthermore, such as Figure 12As shown, the first keel 161 and the second keel 162 are spirally wound in the same direction along the circumferential interval on the lumen support 10. A braided filament forming some keel segments of the first keel 161 spirals from one end of the first keel 161 in a direction opposite to the spiral direction of the first keel 161 onto the lumen support 10, extending to the keel segment of the second keel 162 located at the position of the tubular body 12. It can be understood that another braided filament forming some keel segments of the second keel 162 is also spiraled in the lumen support 10 near the circumferential end. The tail section at the proximal and / or distal end spirals from one end of the second keel 162 in a direction opposite to the spiral direction of the second keel 162 onto the lumen support 10, and extends to the keel section of the first keel 161 located at the position of the tubular body 12. This allows the first keel 161 and the second keel 162 to be circumferentially connected at the proximal and / or distal ends, simultaneously increasing the radial support force of the first segment 11 and / or the second segment 13 of the lumen support 10. Furthermore, the circumferential connection of the keel at the first segment 11 further prevents axial shortening. Figure 12 As shown, taking the first segment 11 as an example, the first tail segment 163 spirals from one end of the first keel 161 in a direction opposite to the spiral direction of the first keel 161 (i.e., the tail end of the first keel 161 folds back from the distal end of the tubular support 10) and extends to the keel segment of the second keel 162 located at the position of the tubular body 12, so that the first tail segment 163 extends circumferentially across the second keel 162; the second tail segment 164 spirals from one end of the second keel 162 in a direction opposite to the spiral direction of the second keel 162. The second tail segment 164 extends in a directional spiral (i.e., the tail end of the second keel 162 folds back from the distal end of the lumen support 10) and extends to the keel segment of the first keel 161 located at the position of the tubular body 12. This allows the second tail segment 164 to extend circumferentially across the first keel 161, thus connecting the first keel 161 and the second keel 162 circumferentially at the distal end. This slightly increases the radial support force of the first segment 11 of the lumen support 10. Simultaneously, the circumferential connection of the keels at the first segment 11 further prevents axial shortening. It is understood that the tail segments of the first keel 161 and the second keel 162 at the second segment 13 (proximal end) can also be configured in the same way as at the distal end, allowing the first keel 161 and the second keel 162 to connect circumferentially at the proximal end. This slightly increases the radial support force of the second segment 13 of the lumen support 10. Simultaneously, the circumferential connection of the keels at the second segment 13 further prevents axial shortening. Further details are omitted here. In other embodiments, the lumen support 10 may also include three keels, with any one keel extending across to its adjacent keel, so that the three keels are connected in the circumferential direction, which may also slightly increase the radial support force of the first segment 11 and the second segment 13 of the lumen support 10.
[0066] This utility model also provides a support system 100, such as Figure 13-16 As shown, the support system 100 includes a conveyor 30 and a lumen support 10. The conveyor 30 includes a sheath core 31, a guide head 32, a support rod 33, a sheath tube 34, an anchor 35, and a handle assembly. The guide head 32 is located at the distal end of the sheath core 31. The sheath tube 34 is arranged around the support rod 33 and the sheath core 31. The support rod 33 is arranged around the sheath core 31. The sheath core 31, the support rod 33, and the sheath tube 34 are sequentially sleeved from the inside to the outside. The sheath tube 34 can move axially... As the sheath core 31 moves, the support rod 33 is sleeved on the outside of the sheath core 31, and the guide head 22 is located at the distal end of the sheath core 31. The distal end of the support rod 33 and the proximal end of the guide head 22 are spaced apart to form a loading space for the lumen support 10. The anchor 35 is located on the sheath core and at the distal end of the loading space so that when the lumen support is radially compressed and loaded into the sheath, the high wave of the first segment of the distal end of the lumen support can be hooked onto the anchor 35.
[0067] Combination Figure 15-16 As shown, because the first annular end wavering at the distal end of the stent has a structure with alternating high and low waves, when the stent is radially compressed into the sheath, the high wave of the first annular end wavering hooks onto the anchor 35. This wavering, being at the same height as the distal end of the stent, reduces the number of single waves at the hook point, thus lowering the steric hindrance when the stent is circumferentially compressed at the distal end. It also reduces the loading force at the distal end and maintains the stability of the stent during loading. Furthermore, when the stent is released, the low wave unfolds first, followed by the high wave, reducing the excessive radial force required for the first annular end wavering to shorten the stent's length. Additionally, the height difference between the high and low waves reduces the contact point between the wave bend at the first free end of the stent and the same circumferential vessel, thus reducing stimulation to the vessel wall.
[0068] 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.
[0069] The embodiments described above are merely illustrative of several implementations of this utility model, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the utility model patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this utility model, and these all fall within the protection scope of this utility model. Therefore, the protection scope of this utility model patent should be determined by the appended claims.
Claims
1. A lumen stent, characterized in that, The lumen support is woven from braided yarns and includes a tubular body and a first segment. The first segment is located at the distal end of the tubular body and is flared. The first segment includes a connecting end and a free end. The connecting end is connected to the tubular body. The braided yarn includes a first tail segment, which is wound around the same braided yarn or another braided yarn spool. The first tail segment includes an end, and the outer diameter at the end is larger than the yarn diameter at other parts of the first tail segment.
2. The lumen stent according to claim 1, characterized in that, The tubular body includes a plurality of annular corrugated coils arranged along the axial direction, and two adjacent annular corrugated coils are connected by hooks. The lumen support includes at least one keel, which is spirally arranged around the axial direction on the lumen support.
3. The lumen stent according to claim 2, characterized in that, The keel and the braided wire are an integral structure. The at least one keel includes a first keel and a second keel. The lumen support includes multiple wave rods from the proximal end to the distal end. The second keel is spirally wound around the adjacent wave rod around the axial direction of the lumen support, thereby forming a gap with the wave rod. The tail end of the first keel is folded back and passes through at least one of the gaps.
4. The lumen stent according to claim 2, characterized in that, The number of keels is one, and it is an integral structure with the braided wire. The tail end of the keel is folded back from the first section to the tubular body.
5. The lumen stent according to claim 2, characterized in that, The annular wave ring includes a crest, a trough, and a wave rod. The wave rod extends between the crest and the trough. The keel spirals around the wave rod at least once and forms a gap with the wave rod. The tail end of the keel passes through the gap.
6. The lumen stent according to any one of claims 2-5, characterized in that, The tail end of the keel includes an end section and a sub-tail section, wherein the radial dimension of the end section is greater than the radial dimension of the sub-tail section.
7. The lumen stent according to claim 2, characterized in that, The keel includes a first keel and a second keel spaced circumferentially apart. The tail end of the first keel is folded back from the proximal or distal end of the lumen support and extends circumferentially across the second keel; and / or the tail end of the second keel is folded back from the proximal or distal end of the lumen support and extends circumferentially across the first keel.
8. The lumen stent according to claim 1, characterized in that, The first segment expands outward from the proximal end to the distal end and then extends straight. The tubular body includes multiple annular waverings arranged along the axial direction. The wave height of the low wave in the first segment is greater than the wave height of any of the annular waverings. And / or the lumen stent includes a second segment located at the proximal end of the lumen stent, the second segment extending outward from the distal end to the proximal end and then straightening, the tubular body including a plurality of axially arranged annular corrugations, the wave height of the low wave of the second segment being greater than the wave height of any of the annular corrugations.
9. The lumen stent according to claim 8, characterized in that, The distal end of the lumen support includes a first developing element, and the high wave on the distal end side of the lumen support includes a first wave rod and a second wave rod. The first wave rod and the second wave rod cross at the distal end of the lumen support and are smoothly connected to form a developing hole. The first developing element is wound around the circumference of the developing hole. And / or, the proximal end of the lumen stent includes a second imaging element, the second segment includes a second annular end wave, the high wave of the second annular end wave includes a third wave rod and a fourth wave rod, the third wave rod and the fourth wave rod cross at the proximal end of the lumen stent and are smoothly connected to form another imaging hole, and the second imaging element is wound around the circumference of the other imaging hole.
10. The lumen stent according to claim 2, characterized in that, The lumen support is woven from at least one braided wire. The lumen support includes a first annular end corrugation. The keel includes a first keel segment. The first annular end corrugation is formed circumferentially by the braided wire. The first keel segment is wound around one of the corrugations of the first annular end corrugation. The first annular end corrugation and the first keel segment are the portions adjacent to the braided wire.
11. The lumen stent according to claim 10, characterized in that, The lumen support includes another braided wire, the tubular body includes a first annular body wavering from the distal end to the proximal end, the first segment is hooked and connected to the first annular end wavering, the keel includes a second keel segment, the other braided wire is wound around a wave rod of the first annular body wavering to form the second keel segment, the first annular body wavering and the second keel segment are the parts adjacent to the other braided wire.
12. The lumen stent according to claim 1, characterized in that, The first segment includes a high wave and a low wave along the circumferential direction. The waveform inflection point of the high wave at the free end and the waveform inflection point of the low wave at the free end are not on the same radial section.