Lumen stent
By designing the fitting and reinforcing structures of the luminal stent, the problems of tissue coverage and blood flow deformation after the stent is released into the iliac vein were solved, thus achieving stent stability and smooth blood flow.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- LIFETECH SCI (SHENZHEN) CO LTD
- Filing Date
- 2021-12-22
- Publication Date
- 2026-07-21
AI Technical Summary
After existing stents are deployed in the iliac vein, they are prone to being covered by tissue in the inferior vena cava, increasing the probability of thrombosis. Furthermore, they can deform under the scouring of blood flow, affecting blood flow stability.
A luminal stent is designed, comprising a support segment and an extension segment. The extension segment has an inclined fitting portion and a reinforcing portion. The fitting portion is inclined toward the outer side of the blood vessel, and the reinforcing portion is arranged axially and located on the right iliac vein side. This structural design reduces obstruction to blood flow and enhances the stability of the stent within the blood vessel.
It reduces the obstruction of blood flow by the stent, lowers the risk of thrombosis, improves the stability and support of the stent in the blood vessel, and adapts to the natural deformation of the blood vessel.
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Figure CN116327462B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical devices, and in particular to a lumen stent. Background Technology
[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.
[0003] like Figures 1 to 3 As shown, iliac vein compression syndrome is a blood return obstruction disease caused by compression of the iliac vein, usually formed by long-term compression of the iliac vein by the iliac artery 3 and the lumbosacral joint 7. In the prior art, after the stent 1 is released in the left iliac vein 5, one end of the stent 1 extends axially along the left iliac vein 5 into the inferior vena cava 2. In the long term after stent 1 implantation, the tissue in the inferior vena cava 2 can easily climb over the outer wall of the stent 1 to form a tissue membrane, thereby simultaneously obstructing the blood flow on the same side (blood flow in the left iliac vein 5) and the blood flow on the opposite side (blood flow in the right iliac vein 4), increasing the probability of thrombosis. Summary of the Invention
[0004] Therefore, it is necessary to provide a lumen stent, including a tubular body, the tubular body including a support section and at least one extension section, the extension section being connected to one axial end of the support section, the extension section including a fitting portion and a reinforcing portion disposed opposite to each other, the fitting portion being inclined toward the outside of the tubular body relative to the axis of the tubular body, and the reinforcing portion being disposed along the axial direction of the tubular body.
[0005] Optionally, the stiffness of the reinforcing part is greater than the stiffness of the bonding part.
[0006] Optionally, the extension section includes a multi-turn waveform structure, in the region where the reinforcement is located, two adjacent waveform structures intersect and are fixedly connected, and in the region where the fitting is located, two adjacent waveform structures intersect and are movably connected.
[0007] Optionally, the extension further includes at least two compliant portions located between the bonding portion and the reinforcing portion, wherein the stiffness of the compliant portions is less than the stiffness of the bonding portion.
[0008] Optionally, the area of the smallest mesh on the compliant portion is smaller than the area of the largest mesh on the reinforcing portion.
[0009] Optionally, the wave angle on the waveform structure of the reinforcing portion and / or the bonding portion is greater than the wave angle on the waveform structure of the second region.
[0010] Optionally, the fitting portion has an arc-shaped structure.
[0011] Optionally, the support segment includes a plurality of first regions and second regions arranged circumferentially along the tubular body, wherein the first region is located between two adjacent second regions, and the stiffness of the first region is greater than that of the second region.
[0012] Optionally, the support segment further includes an annular waveform unit and a reinforcing structure, the reinforcing structure being connected to at least one annular waveform unit in the first region.
[0013] Optionally, the reinforcing structure is a corrugated structure, and the corrugation angle of the reinforcing structure is smaller than the corrugation angle on the annular waveform unit.
[0014] Compared with the prior art, the lumen stent of the present invention has the following advantages:
[0015] This invention utilizes a fitting portion located at the end of the extension segment furthest from the support segment. This fitting portion is axially inclined towards the outside of the stent relative to the tubular body. After the stent is released within the blood vessel, the fitting portion can adhere to the inner wall of the inferior vena cava near the left iliac vein, thereby reducing the stent's obstruction of ipsilateral and contralateral blood flow. In the long term after stent implantation, tissue within the inferior vena cava forms a tissue membrane on the fitting portion. The surface energy of this tissue membrane is lower than that of the stent, further reducing its obstruction of ipsilateral and contralateral blood flow. This tissue membrane also fixes the extension segment, preventing deformation and blood flow disturbance caused by blood flow, thus increasing the stent's stability within the blood vessel. Furthermore, because the axial end of the extension segment is prone to radial expansion due to compression from the iliac artery and sacrum, the axial inclination of the fitting portion towards the outside of the tubular body allows the expanded extension segment to better conform to the arc-shaped transition section at the junction of the left iliac vein and the inferior vena cava.
[0016] By setting the reinforcing part opposite to the fitting part, the reinforcing part is located on the side of the extension closer to the right iliac vein. By extending the reinforcing part along the axial direction of the tubular body, the reinforcing part can extend to the central area where the left and right iliac veins intersect, thereby ensuring support for the area where the left and right iliac veins intersect, and giving the extension section good support as well as good long-term stability. Attached Figure Description
[0017] Figure 1 This is a schematic diagram of the iliac vein being compressed according to the present invention;
[0018] Figure 2 This is a schematic diagram of the stent of the present invention within the iliac vein;
[0019] Figure 3 This is a schematic cross-sectional view of the compressed iliac vein in the present invention.
[0020] Figure 4 This is a schematic diagram of the structure of the extension segment within the inferior vena cava in an embodiment of the present invention;
[0021] Figure 5 This is a schematic diagram of the structure of the extension section in an embodiment of the present invention;
[0022] Figure 6 For the present invention Figure 5 Enlarged structural diagram at point A in the diagram;
[0023] Figure 7 For the present invention Figure 5 Enlarged schematic diagram of the structure at point B in the diagram;
[0024] Figure 8 This is a schematic diagram of the structure of the support when it is not compressed in an embodiment of the present invention;
[0025] Figure 9 This is a schematic diagram of the structure of the support under compression in an embodiment of the present invention;
[0026] Figure 10 This is another structural schematic diagram of the extension section in an embodiment of the present invention;
[0027] Figure 11 For the present invention Figure 10 Enlarged schematic diagram of the structure at point C;
[0028] Figure 12 This is a schematic diagram of the unfolded structure of the extension segment in an embodiment of the present invention;
[0029] Figure 13 For the present invention Figure 12 Enlarged schematic diagram of the structure at point D;
[0030] Figure 14 This is a schematic diagram of the support segment in an embodiment of the present invention;
[0031] Figure 15 This is a schematic diagram of the unfolded structure of the support segment in an embodiment of the present invention;
[0032] Figure 16 This is a top view of the support segment in an embodiment of the present invention;
[0033] Figure 17 This is a schematic diagram of another unfolded structure of the support segment in an embodiment of the present invention;
[0034] Figure 18 For the present invention Figure 17 Enlarged schematic diagram of the structure at point E in the diagram;
[0035] Figure 19 This is a schematic diagram of another unfolded structure of the support segment in an embodiment of the present invention;
[0036] Figure 20 For the present invention Figure 19 Enlarged schematic diagram of the structure at point F;
[0037] Figure 21 This is a schematic diagram showing the unfolded tubular body in an embodiment of the present invention;
[0038] Figure 22 For the present invention Figure 21 Enlarged schematic diagram of the structure at point G in the diagram;
[0039] Figure 23 For the present invention Figure 21 A magnified schematic diagram of the structure at point H in the diagram. Detailed Implementation
[0040] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.
[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
[0042] like Figures 1 to 3 As shown, iliac vein compression syndrome usually occurs on the left iliac vein 5. After the stent 1 is released in the left iliac vein 5, the extension extends along the axis of the left iliac vein 5 into the inferior vena cava 2. On the one hand, in the long term after stent 1 is implanted, the tissue in the inferior vena cava 2 is prone to climb over the outer wall 16 of the stent 1 to form a tissue membrane, thereby simultaneously obstructing the blood flow on the same side (blood flow in the left iliac vein 5) and the blood flow on the opposite side (blood flow in the right iliac vein 4), increasing the probability of thrombosis. On the other hand, the stent extending into the inferior vena cava 2 is suspended in the inferior vena cava 2 and is prone to deformation and displacement under the flushing of blood flow, thus disturbing the blood flow.
[0043] Example 1
[0044] To address the aforementioned technical problems, this embodiment provides a lumen stent, such as... Figure 4As shown, it includes a tubular body, which includes a support section 12 and an extension section 11. The extension section 11 is connected to one axial end of the support section 12. The extension section 11 includes a fitting portion 111 and a reinforcing portion 112 disposed opposite to each other. The fitting portion 111 is inclined towards the outside of the tubular body relative to the axis of the tubular body, and the reinforcing portion 112 is disposed along the axial direction of the tubular body.
[0045] It should be noted that the iliac vein is located anterior to the iliac artery 3 and posterior to the lumbosacral joint 7 or lumbar vertebrae. The delivery device delivers the luminal stent 1 into the iliac vein through the femoral vein and releases the stent 1. After being released into the iliac vein, the stent 1 expands radially along the blood vessel to support the iliac vein in a position where it is compressed and deformed, thus ensuring the smooth flow of blood within the iliac vein.
[0046] The tubular body includes an extension segment 11 and a support segment 12. The extension segment 11 is connected to one axial end of the support segment 12 and extends along the axial direction of the support segment 12. After the stent is released in the blood vessel, the support segment 12 is located in the left iliac vein 5, and the extension segment 11 extends from the left iliac vein 5 into the inferior vena cava 2.
[0047] The extension segment 11 includes a fitting portion 111, which is located at the end of the extension segment 11 away from the support segment 12. The fitting portion 111 is inclined relative to the axial direction of the tubular body towards the outer side of the tubular body. It should be noted that the fitting portion 111 fits against the inner wall of the inferior vena cava 2 near the left iliac vein 5, and the fitting portion 111 is inclined relative to the axis of the stent 1 towards the side wall of the inferior vena cava 2. Figure 5 As shown, the included angle c between the fitting part 111 and the axis of the bracket 1 is 135° to 180°. Specifically, the included angle c between the fitting part 111 and the axis of the bracket 1 is 135°, 140°, 150°, 160°, 165° or 180°.
[0048] In other embodiments, the fitting portion 111 may also be an arc-shaped structure, which facilitates the fitting portion 111 to fit into the transition area connecting the left iliac vein 5 and the inferior vena cava 2 after the stent 1 is released, thereby increasing the wall adhesion of the tubular body.
[0049] The reinforcing section 112 is located on the side wall of the extension segment 11 near the right iliac vein 4. The reinforcing section 112 is disposed opposite to the fitting section 111 and is disposed along the axial direction of the tubular body. It should be noted that when the extension segment 11 extends to the inferior vena cava 2, the orientation of the mesh at the reinforcing section 112 is approximately parallel to the blood flow direction in the inferior vena cava 2.
[0050] Furthermore, in order to make it easier for the fitting portion 111 to fit the inner wall of the inferior vena cava 2, this embodiment further limits the stiffness of the reinforcing portion 112 to be greater than the stiffness of the fitting portion 111.
[0051] like Figures 5 to 7 As shown, the tubular body includes a multi-turn waveform structure. At the reinforcing part 112, two adjacent waveform structures intersect and are fixedly connected. At the fitting part 111, two adjacent waveform structures intersect and are movably connected.
[0052] In this embodiment, the tubular body is formed by braiding filaments and includes multiple turns of wavy rings, with the crests and troughs of adjacent turns intersecting, such as... Figure 6 As shown, at the reinforcing portion 112, two adjacent corrugated rings intersect and are fixedly connected, forming a constraint between them. This makes the deformation resistance of the reinforcing portion 112 greater than that of the fitting portion 111. Specifically, the fixed connection can be achieved by welding or wrapping. Figure 7 As shown, at the bonding portion 111, the intersection of two adjacent corrugated rings is movably connected, meaning that the two adjacent corrugated rings can slide relative to each other under stress, thereby making the deformation resistance of the reinforcing portion 112 greater than that of the bonding portion 111. Thus, by making the two adjacent corrugated rings at the reinforcing portion 112 fixedly connected and the two adjacent corrugated rings at the bonding portion 111 movably connected, the reinforcing portion 112 and the bonding portion 111 can have different deformation resistances while maintaining a fixed mesh ratio.
[0053] The advantage of this design is that after the stent 1 is released into the blood vessel, the abutment portion 111, located at the end of the extension segment 11 furthest from the support segment 12, is axially inclined towards the outside of the stent 1 relative to the tubular body. This allows the abutment portion 111 to adhere to the inner wall of the inferior vena cava 2 near the left iliac vein 5, thereby reducing the obstruction of ipsilateral and contralateral blood flow by the stent 1. In the long term after stent 1 implantation, tissue within the inferior vena cava 2 will coat the abutment portion 111 to form a tissue membrane. The tissue membrane has low surface energy, further reducing resistance to ipsilateral and contralateral blood flow. The tissue membrane also helps to fix the extension segment 11, preventing deformation and disruption of blood flow caused by blood flow, thus increasing the stability of the stent 1 within the blood vessel. Additionally, as... Figure 8 As shown, before being compressed, the support 1 has a cylindrical structure, such as... Figure 9 As shown, after the stent 1 is compressed by the artery and sacrum, the end of the stent 1 near the inferior vena cava 2 tends to tilt towards the outside of the stent 1. By setting the fitting portion 111 to tilt towards the outside of the tubular body relative to the axial direction of the tubular body, the extension segment 11 can better conform to the arc-shaped transition section of the connection area between the left iliac vein 5 and the inferior vena cava 2 after expansion.
[0054] Furthermore, since the iliac artery 3 typically covers the junction 6 of the left iliac vein 5, right iliac vein 4, and inferior vena cava 2, if the reinforcing portion 112 and the adhering portion 111 are simultaneously tilted relative to the axial direction of the tubular body towards the outside of the tubular body, with the reinforcing portion 112 adhering to the right iliac vein 4 and the adhering portion 111 adhering to the inferior vena cava 2, the tubular body will fail to support the junction 6 of the left iliac vein 5 and the right iliac vein 4. However, the coverage area of the iliac artery 3 at the transition area connecting the left iliac vein 5 and the inferior vena cava 2 is small, and even if the adhering portion 111 is tilted, it will not cause the tubular body to fail to support the left iliac vein 5. By having the reinforcing part 112 and the fitting part 111 arranged opposite to each other, the reinforcing part 112 is located on the side of the extension segment 11 close to the right iliac vein 4. By extending the reinforcing part 112 along the axial direction of the tubular body, the reinforcing part 112 can extend to the central area where the left iliac vein 5 and the right iliac vein 4 intersect, thereby ensuring support for the intersection area 6 of the left iliac vein 5 and the right iliac vein 4, and giving the extension segment 11 good support as well as good long-term stability.
[0055] Example 2
[0056] The difference between this embodiment and Implementation 1 is that, as Figure 10 , Figure 11 As shown, the tubular body includes multiple waveform structures 215 and connecting structures 213. In the region where the reinforcement 212 is located, the connecting structure 113 connects two adjacent waveform structures 215.
[0057] In this embodiment, the first waveform structure includes a first peak and a first trough, and the second waveform structure includes a second peak and a second trough. The first peak and the second trough are arranged opposite to each other, and the first trough and the second peak are arranged opposite to each other. There are multiple connecting structures 213, including a first connecting structure and a second connecting structure. In the region where the reinforcing part 212 is located, the two ends of the first connecting structure connect the first peak and the second trough, and the two ends of the second connecting structure connect the second peak and the second trough. This constrains the first and second waveform structures, increasing the stiffness of the reinforcing part 112. In the region where the fitting part 111 is located, there is no connection between adjacent two-ring waveform structures to form a constraint, and there is a certain amount of movement between adjacent two-ring waveform structures, thus giving the fitting part 111 better deformation performance. Therefore, the stiffness of the reinforcing part 112 is greater than that of the fitting part 111.
[0058] In some embodiments, the number of waveform structures is between 6 and 20. Specifically, the number of waveform structures can be 6, 10, 13, 16, and 20.
[0059] The advantage of this design is that, by setting the deformation resistance of the reinforcing part 112 to be greater than that of the fitting part 111 on the extension section, when the tubular body is compressed by the sacrum and iliac artery 3, on the one hand, the reinforcing part 112 will not bend to the right iliac vein 4, thus ensuring the support performance of the extension section 11 within the inferior vena cava 2; on the other hand, the fitting part 111 has a better degree of freedom of deformation, allowing the fitting part 111 to deform towards the inferior vena cava 2 to fit against the inner wall of the inferior vena cava 2, increasing the wall-adherence of the fitting part 111.
[0060] Furthermore, such as Figure 10 , Figure 12 As shown, the extension section 21 further includes at least two compliant portions 214, which are located between the fitting portion 211 and the reinforcing portion 212, and the stiffness of the compliant portion 214 is less than the stiffness of the reinforcing portion 212.
[0061] The reinforcing portion 212, the compliant portion 214, and the fitting portion 211 are arranged circumferentially along the tubular body, with the compliant portion 214 separating the fitting portion 211 and the reinforcing portion 212. In this embodiment, as... Figure 13 As shown, the softening portion 214 includes a first softening portion 2141 and a second softening portion 2142. The reinforcing portion 212 is disposed opposite to the fitting portion 211. The first softening portion 2141 and the second softening portion 2142 are disposed opposite to each other. The first softening portion 2141, the second softening portion 2142, the reinforcing portion 212 and the fitting portion 211 are arranged in a cross-shaped symmetrical arrangement.
[0062] In this embodiment, braided filaments of different diameters are provided in the compliant portion 214, the reinforcing portion 212, and the bonding portion 211 to provide different stiffnesses. For example, the braided filaments have a larger diameter in the reinforcing portion 212 and the bonding portion 211, while the braided filaments have a smaller diameter in the compliant portion 214. Thus, the larger diameter braided filaments can provide greater stiffness to the first region, giving the reinforcing portion 212 and the bonding portion 211 stronger resistance to deformation, while the smaller diameter braided filaments can provide less stiffness to the compliant portion 214, giving the compliant portion 214 stronger deformation capacity.
[0063] In other embodiments, materials with different stiffnesses can be provided at the compliant portion 214, the reinforcing portion 212, and the bonding portion 211. For example, stainless steel wire can be provided at the reinforcing portion 212 and the bonding portion 211, and nickel-titanium wire can be provided at the compliant portion 214. In this way, the reinforcing portion 212 and the bonding portion 211 have strong resistance to deformation, and the compliant portion 214 has strong deformation capacity.
[0064] The advantage of this design is that the compliant portion 214 has good deformability to increase the contact area between the stent 1 and the inner wall of the blood vessel, thereby reducing the contact pressure between the side wall of the stent 1 and the inner wall of the blood vessel; the reinforcing portion 112 and the fitting portion 111 have good anti-deformation properties, providing radial support force for the compliant portion 114, thereby ensuring that the stent 1 has sufficient support strength while having good deformation adaptability, and ensuring that the inner side of the stent 1 has sufficient flow area.
[0065] like Figure 12 As shown, the area of the smallest mesh on the reinforcing part 212 is greater than the area of the largest mesh on the compliant part 214.
[0066] The sidewalls of the tubular main body have a mesh structure. After the stent 1 is implanted into the iliac vein, the extension segment 21 extends into the inferior vena cava 2. The mesh of the reinforcing part 212 is oriented parallel to the direction of blood flow within the inferior vena cava 2, while the mesh of the compliant part 214 is oriented perpendicular to the direction of blood flow within the inferior vena cava 2. It should be noted that the mesh on the reinforcing part 212 refers to the mesh S1 formed by two adjacent wave structures 215 and two adjacent connecting structures 213 within the region where the reinforcing part is located. The mesh on the compliant part 214 refers to the mesh S2 formed by two adjacent wave structures with oppositely arranged peaks and troughs within the region where the compliant part 214 is located.
[0067] Furthermore, in order to ensure that the reinforcing part 212 and the bonding part 211 have strong radial support force, and that the area of a single mesh on the reinforcing part 212 is larger than the area of a single mesh on the compliant part 214, this embodiment further limits the wave angle of the reinforcing part 212 to be larger than the wave angle of the compliant part 114.
[0068] It should be noted that, as Figure 13 As shown, the wave angle refers to the angle between the wave rod and the wave crest or trough. θ The angle of the wave at the reinforcing part 212 is 30° to 120°. Specifically, the angle of the wave at the reinforcing part 212 can be 30°, 45°, 50°, 60°, 80°, or 120°. The angle of the wave at the compliant part 214 is 30° to 60°. Specifically, the angle of the wave at the compliant part 214 can be 30°, 45°, 50°, or 60°. The ratio of the angle of the wave at the reinforcing part 212 to the angle of the wave at the compliant part 214 is 1.1 to 4. Specifically, the ratio of the angle of the wave at the reinforcing part 212 to the angle of the wave at the compliant part 214 is 1.1, 1.5, 1.9, 2.3, 3, 3.5, or 4.
[0069] In the waveform structure, the region with a large wave angle has greater stiffness than the region with a small wave angle, requiring greater stress to deform. Therefore, when the tubular body is under stress, the region with a small wave angle has lower stiffness and is more prone to deformation to adapt to compression, while the region with a large wave angle has higher stiffness and thus stronger resistance to deformation, ensuring sufficient radial support capacity of the support. Furthermore, the area of a single mesh opening is larger in the region with a large wave angle and smaller in the region with a small wave angle, thus achieving a setting where the area of a single mesh opening on the reinforcing part 212 is larger than the area of a single mesh opening on the compliant part 214. In this embodiment, the deformation resistance of the support is obtained by pressing the support with a flat plate. Specifically, in an environment of 30°C to 37°C, the support is pressed with a flat plate, and the compression pressure when the support is compressed by 50% is measured sequentially at the reinforcing part 212, the fitting part 211, and the compliant part 214, thereby obtaining the radial deformation resistance of the support region 121 and the compliant region 122. In other embodiments, the deformation resistance test can also be achieved by any one of the following methods in Appendix D of the "Pharmaceutical Industry Standard of the People's Republic of China - YY / T0063.2-2016 - Cardiovascular Implants - Endovascular Devices - Part 2: Vascular Stents": radial compression resistance test, parallel plate compression resistance test, or local compression test.
[0070] The advantage of this design is that when the extension segment 21 extends into the inferior vena cava 2, the mesh orientation on the reinforcing portion 212 is parallel to the blood flow direction within the inferior vena cava 2. By setting the mesh ratio of the reinforcing portion 212 to be greater than that of the compliant portion 214, the blood flow passage area on the reinforcing region 212 is increased. On the one hand, this can reduce the obstruction of blood flow by the stent 1 and reduce the possibility of contralateral venous thrombosis. On the other hand, it can increase the difficulty for tissue within the blood vessel to climb over the reinforcing portion 212 to form a membrane, reducing the probability of the stent s obstructing blood flow in the long term.
[0071] Example 3
[0072] The difference between this embodiment and Embodiment 1 is that, as Figure 14 , Figure 15 As shown, the support section 12 includes a plurality of first regions 121 and second regions 122 arranged along the circumference of the tubular body. The first region 121 is located between two adjacent second regions 122, and the stiffness of the first region 121 is greater than that of the second region 122.
[0073] Before implantation into the blood vessel, the stent 1 is not compressed and has a circular cross-section. After implantation, the stent 1 is compressed and its cross-section becomes elliptical. In some embodiments, the stent 1 can be elliptical before release to accommodate the deformed blood vessel contour caused by compression.
[0074] In this embodiment, multiple first regions 121 and second regions 122 are sequentially connected end-to-end along the circumference of the stent 1 to form a tubular main body. The multiple first regions 121 and second regions 122 are sequentially connected end-to-end. The second region 122 has good deformability to increase the contact area between the stent 1 and the inner wall of the blood vessel, thereby reducing the contact pressure between the sidewall of the stent 1 and the inner wall of the blood vessel. The first region 121 has good resistance to deformation, providing radial support for the second region 122, thus ensuring that the stent 1 has sufficient support strength while having good deformation adaptability, ensuring sufficient flow area for blood flow within the stent 1.
[0075] The advantage of this arrangement is that by arranging the first region 121 and the second region 122 along the circumference of the tubular body, the second region 122 can respectively conform to the sidewalls of the blood vessel near the iliac artery 3 and the lumbosacral joint 7. The relatively low stiffness of the second region 122 allows it to have strong deformation capacity, thus increasing the contact area between the stent 1 and the inner wall of the blood vessel. This prevents excessive pressure between the stent 1 and the inner wall of the blood vessel from causing rupture. Furthermore, the first region 121 is located between two adjacent second regions 121. Between 22, the stiffness of the first region 121 is greater than that of the second region 122, which gives the first region 121 strong resistance to deformation. This allows the first region 121 to provide sufficient radial support for the second region 122, preventing excessive deformation of the second region 122 and long-term failure of support for the blood vessel. On the other hand, since the iliac vein is prone to forming adhesions at the compressed location, the lower mesh ratio of the second region 122 allows the stent 1 to press the adhesions tightly against the inner wall of the blood vessel, preventing the formation of thrombi in the blood vessel after the adhesions tear.
[0076] Furthermore, such as Figure 16 As shown, this embodiment further defines the following: the first region 121 includes a third region 1211 and a fourth region 1212 disposed opposite to each other; the second region 122 includes a fifth region 1221 and a sixth region 1222 disposed opposite to each other; the fifth region 1221 is attached to the inner wall of the blood vessel near the artery; the sixth region 1222 is attached to the inner wall of the blood vessel near the lumbosacral joint 7. The central angle d of the third region 1211 and the fourth region 1212 is 60° to 150°. Specifically, the central angle d of the third region 1211 and the fourth region 1212 is 60°, 90°, 120°, or 150°.
[0077] In other embodiments, the first region 121 and the second region 122 are arranged in a cross-shaped symmetrical configuration. The line connecting the midpoints of the third region 1211 and the fourth region 1222 is perpendicular to the line connecting the midpoints of the fifth region 1221 and the sixth region 1222.
[0078] In this way, when the second region 122 is compressed, the second region 122 transmits the first stress to the first region 121 (as shown by arrow F1 in the figure). The first region 121 can always provide support reaction force in the radial direction (as shown by arrow F2 in the figure). By setting the first region 121 and the second region 122 in a cross-symmetric manner, the first region 122 can maintain the maximum radial support height, ensuring the smooth flow of blood.
[0079] In some embodiments, the ratio of the circumferential lengths of the first region 121 and the second region 122 is 1 to 1.5.
[0080] It should be noted that when the circumferential length of the second region 122 is too long, the central region of the second region 122 is easily compressed and excessively deformed towards the center of the stent 1, affecting blood flow. When the circumferential length of the second region 122 is too long and the second region 122 is deformed under force, the first region 121 is located on the surface where the tubular structure fits against the inner wall of the blood vessel, and the connection between the first region 121 and the second region 122 is prone to forming an acute angle that could puncture the side wall of the blood vessel. Specifically, the ratio of the circumferential lengths of the first region 121 and the second region 122 is 1, 1.1, 1.3, or 1.5.
[0081] Therefore, by setting the ratio of the circumferential length of the first region 121 and the second region 122 to between 1 and 1.5, the ratio of the circumferential length of the first region 121 and the second region 122 is within a suitable range, thereby ensuring that the stent 1 has sufficient deformation performance at the compression point to buffer the compression pressure, and sufficient radial support at the non-compression point to ensure blood flow.
[0082] Example 4
[0083] like Figure 17 , Figure 18 As shown, the difference between this embodiment and Embodiment 3 is that the support segment 22 further includes an annular waveform unit 223 and a reinforcing structure 224. At the first region 221, the reinforcing structure 224 is connected to at least one annular waveform unit 123 on the first region 221.
[0084] In this embodiment, the annular waveform unit 223 includes a first annular waveform unit 2231 and a second annular waveform unit 2232. The first annular waveform unit 2231 includes a first trough, and the second annular waveform unit 2232 includes a second peak. The first trough and the second peak intersect to form a connecting unit 225. The reinforcing structure 224 is a corrugated structure, which is connected to the connecting unit 225 on the first region 221. The opening of the reinforcing structure 224 is opposite to the opening of the connecting unit 225. In other embodiments, the reinforcing structure 224 may also be a V-shaped structure or a rod-shaped structure.
[0085] In other embodiments, the reinforcing structure 224 is a corrugated structure with a corrugation angle h, and the connecting unit 225 is a V-shaped structure with an included angle g. The corrugation angle h of the corrugated structure is smaller than the included angle g of the V-shaped structure. The included angle g of the connecting unit 225 is 120° to 150°, specifically 120°, 130°, 135°, 140°, or 150°. When the support is subjected to axial tension, by setting the included angle h of the reinforcing structure 224 to be smaller than the wave angle g on the annular wave unit 223, on the one hand, the reinforcing structure 224 can pull the two adjacent annular wave units 223, thereby increasing the axial displacement resistance of the support. On the other hand, it can reduce the stress of the reinforcing structure 224 on the support under compression. If the wave angle h is greater than the included angle g, the reinforcing structure 224 will be straightened first when the support is compressed, thereby limiting the axial tension of the connecting unit 225 and increasing the stress of the support under compression.
[0086] The advantage of this configuration is that by connecting the reinforcing structure 224 with the annular waveform unit 223, the reinforcing structure 224 can form radial support at the first region 221, increasing the radial support force of the first region 221, thereby increasing the support effect on the inner wall of the blood vessel.
[0087] In other embodiments, such as Figure 19 , Figure 20 As shown, the reinforcing structure 324 includes an arc-shaped structure and a reinforcing rod 3242. The arc-shaped structure includes a first arc-shaped structure 3241 and a second arc-shaped structure 3243. The two ends of the reinforcing rod 3242 are respectively connected to the first arc-shaped structure 3241 and the second arc-shaped structure 3243. The first arc-shaped structure 3241 is connected to the first wave crest, and the second arc-shaped structure 3243 is connected to the second wave trough.
[0088] In this embodiment, the first annular waveform unit 3241 includes a first trough and a first peak, and the second annular waveform unit 3242 includes a second peak and a second trough. The first trough and the second peak are arranged opposite to each other, and the first peak and the second trough are arranged opposite to each other. In the first region 321, the first arc-shaped structure 3241 is connected to the first peak, and the second arc-shaped structure 3243 is connected to the second trough.
[0089] The advantage of this design is that the first arc-shaped structure 3241 is connected to the first peak, allowing it to support the peak. The second arc-shaped structure 3243 is connected to the second trough, allowing it to support the trough. The reinforcing rod 3242 is connected to the first and second arc-shaped structures 3241 and 3243 at both ends. This design increases the radial deformation resistance of the support section 32. It also increases the metal coverage of the first region 321, reduces the mesh area of the first region 321, and prevents proliferating tissue from passing through the first region 321 into the tubular body, thereby reducing the probability of restenosis within the stent.
[0090] Example 5
[0091] like Figures 21 to 23 As shown, the waveforms on the extension segment 41 have opposite phases, while the waveforms on the support segment 42 have the same phase.
[0092] In this embodiment, the extension segment 41 includes a first waveform ring 411 and a second waveform ring 412, and the main body segment 42 includes a third waveform ring 421 and a fourth waveform ring 422. The first waveform ring 411 includes a first peak 4111 and a first trough 4112, and the second waveform ring 412 includes a second peak 4121 and a second trough 4122. The first peak 4111 and the second trough 4122 are arranged opposite to each other, and the first trough 4112 and the second peak 4122 are arranged opposite to each other, so that the waveforms on the extension segment 41 are out of phase. The third waveform ring 421 includes a third peak 4211 and a third trough 4212, and the fourth waveform ring 422 includes a fourth peak 4221 and a fourth trough 4222. The third peak 4211 and the fourth peak 4221 are located on the same vertical line, and the third trough 4212 and the fourth trough 4222 are located on the same vertical line, so that the waveforms on the main body segment 42 are in phase.
[0093] Therefore, when the extension segment 41 is located within the inferior vena cava 2, the waveform phases on the extension segment 41 are set to be opposite, allowing adjacent two-ring waveform structures to interfere with each other, reducing the probability of the extension segment 41 being displaced by blood flow, thereby reducing the possibility of the extension segment 41 moving and disturbing blood flow; the waveform phases on the support segment 42 are set to be the same, allowing the waveform structures on the support segment 42 to have a large degree of freedom of movement, thus giving the support segment 42 better axial flexibility and making the support segment 42 more adaptable.
[0094] 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.
[0095] 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. A lumen stent, characterized in that, The device includes a tubular body, which includes a support section and at least one extension section. The extension section is connected to one axial end of the support section. The extension section includes a fitting portion and a reinforcing portion disposed opposite to each other. The fitting portion and the reinforcing portion are disposed circumferentially along the tubular body. The deformation resistance of the reinforcing portion is greater than that of the fitting portion. The fitting portion is inclined toward the outside of the tubular body relative to the axis of the tubular body. The reinforcing portion is disposed axially along the tubular body.
2. The lumen stent according to claim 1, characterized in that, The stiffness of the reinforcing part is greater than that of the bonding part.
3. The lumen stent according to claim 2, characterized in that, The extension section includes a multi-turn waveform structure. In the region where the reinforcement is located, two adjacent waveform structures intersect and are fixedly connected. In the region where the fitting is located, two adjacent waveform structures intersect and are movably connected.
4. The lumen stent according to any one of claims 1-3, characterized in that, The extension section further includes at least two compliant portions located between the bonding portion and the reinforcing portion, wherein the stiffness of the compliant portions is less than that of the bonding portion.
5. The lumen stent according to claim 4, characterized in that, The area of the smallest mesh on the compliant part is smaller than the area of the largest mesh on the reinforcing part.
6. The lumen stent according to claim 5, characterized in that, The wave angle of the reinforcing part is greater than that of the compliant part.
7. The lumen stent according to claim 1, characterized in that, The bonding part has an arc-shaped structure.
8. The lumen stent according to claim 1, characterized in that, The support segment includes a plurality of first regions and second regions arranged circumferentially along the tubular body. The first region is located between two adjacent second regions, and the stiffness of the first region is greater than that of the second region.
9. The lumen stent according to claim 8, characterized in that, The support segment further includes an annular waveform unit and a reinforcing structure, wherein the reinforcing structure is connected to at least one annular waveform unit in the first region.
10. The lumen stent according to claim 9, characterized in that, The reinforcement structure is a corrugated structure, and the wave angle of the reinforcement structure is smaller than the wave angle of the annular waveform unit.