Lumen stent

By using a luminal stent composed of an inner and outer skeleton in the treatment of aortic dissection, the problem of laparotomy caused by friction between the main stent and the branch stents was solved, thus achieving protection of the laparotomy and reduction of endoleak.

CN116407330BActive Publication Date: 2026-06-26LIFETECH SCI (SHENZHEN) CO LTD

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
LIFETECH SCI (SHENZHEN) CO LTD
Filing Date
2021-12-30
Publication Date
2026-06-26

AI Technical Summary

Technical Problem

In the treatment of aortic dissection, the main stent and branch stents may rupture due to friction caused by blood pulsation pressure, leading to endoleak.

Method used

A lumen stent was designed, comprising an inner skeleton and an outer skeleton. The outer skeleton is located outside the membrane and forms a protective layer to prevent the main stent from rubbing against the membrane.

Benefits of technology

It effectively protects the membrane, prevents rupture caused by friction, reduces the risk of internal leakage, and improves treatment outcomes.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application relates to a kind of luminal stent.The luminal stent includes tubular body and covering film, tubular body includes inner skeleton and outer skeleton, covering film is arranged on inner skeleton, outer skeleton is sleeved on inner skeleton, and outer skeleton is used to form protective layer on the outside of covering film.Thereby, by the fact that outer skeleton is sleeved on inner skeleton, outer skeleton is located on the outside of covering film, when main support and luminal stent rub, outer skeleton can form barrier on the outside of covering film, prevent main support and covering film from rubbing, so as to realize the protection of covering film.
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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] Endovascular aortic repair (EVAR) has been widely used in clinical practice due to its advantages such as simple operation, minimal trauma, and short operation time, and has gradually become an important means of treating aortic dissection.

[0004] like Figure 1 As shown, when aortic dissection occurs in the aortic arch, in order to ensure blood flow to the aortic arch and its three branches while isolating the lesion, a combination of a main stent 700 and a branch stent 100 is usually used to achieve the above effect. However, under the repeated action of the periodic pulsating pressure of the blood, the main stent 700 and the branch stent 100 will produce slight shaking, which will cause the sidewalls of the main stent 700 and the branch stent 100 to rub against each other, causing the lining to rupture and resulting in endoleak. Summary of the Invention

[0005] Therefore, it is necessary to provide a lumen support, including a tubular body and a membrane. The tubular body includes an inner skeleton and an outer skeleton. The membrane is disposed on the inner skeleton, and the outer skeleton is sleeved on the inner bracket. The outer skeleton is used to form a protective layer on the outside of the membrane.

[0006] Optionally, the exoskeleton has a mesh structure and includes a first sidewall and a second sidewall. When the exoskeleton is in its natural state, the smallest mesh area on the first sidewall is smaller than the smallest mesh area on the second sidewall. When the exoskeleton is in a bent state, the first sidewall is the large bend side and the second sidewall is the small bend side.

[0007] Optionally, the second sidewall is connected to the internal skeleton, and at least one part of the first sidewall is suspended to form a free end.

[0008] Optionally, the outer skeleton is formed by weaving filaments, with the filaments on the first sidewall hooking together and the filaments on the second sidewall forming two adjacent crests and troughs in the axial direction that do not interfere with each other.

[0009] Optionally, the inner skeleton includes a first segment, a second segment, and a third segment connected in sequence, with the second segment located between the first and third segments, and the second segment having greater flexibility than the first and third segments, and the outer skeleton covering the second segment.

[0010] Optionally, the second segment includes multiple wave-shaped rings, which are spaced apart along the axial direction of the second segment.

[0011] Optionally, the waveform ring includes peaks and troughs, with the peaks of two axially adjacent waveform rings located on the same straight line and the troughs of two axially adjacent waveform rings located on the same straight line.

[0012] Optionally, the outer skeleton is formed by weaving filaments, and the intersection of the filaments on the outer skeleton is located between two axially adjacent wave-shaped loops on the second segment.

[0013] Optionally, the first section, the outer skeleton, and the third section are woven together as a single unit, with the outer diameters of the first and third sections being smaller than the outer diameter of the outer skeleton.

[0014] Optionally, the lumen stent also includes two imaging structures, which are respectively disposed at both ends of the second segment.

[0015] The present invention also provides a support system, including the above-described lumen support, and a main support, wherein the main support has a through hole, and the lumen support is inserted into the through hole and is at least partially located on the outside of the main support.

[0016] Compared with the prior art, the lumen stent and stent system described in this invention have the following advantages:

[0017] This invention utilizes a membrane mounted on an inner frame to form a sealed channel. An outer frame is fitted over the inner frame, positioned outside the membrane. When the main support rubs against the lumen support, especially in the gap between two adjacent corrugated annular structures, the membrane is easily damaged by friction from the main support in this area due to the lack of support. In this case, the outer frame can form a barrier on the outside of the membrane, preventing friction between the main support and the membrane, thereby protecting the membrane. Attached Figure Description

[0018] Figure 1 This is a schematic diagram illustrating the interaction between the main stent and branch stents within a blood vessel in the prior art.

[0019] Figure 2 This is a schematic diagram of the lumen support structure in Embodiment 1 of the present invention;

[0020] Figure 3 This is an exploded structural diagram of the lumen support in Embodiment 1 of the present invention;

[0021] Figure 4 This is another structural schematic diagram of the lumen support in Embodiment 1 of the present invention;

[0022] Figure 5This is an exploded view of the inner and outer skeletons forming a mesh structure in Embodiment 1 of the present invention;

[0023] Figure 6 This is a schematic diagram of the lumen support structure in Embodiment 2 of the present invention;

[0024] Figure 7 This is an exploded view of the lumen support in Embodiment 2 of the present invention;

[0025] Figure 8 This is a schematic diagram of the unfolded structure of the first segment, the outer frame, and the third segment in Embodiment 2 of the present invention;

[0026] Figure 9 This is a schematic diagram of the unfolded structure of the exoskeleton in Embodiment 2 of the present invention;

[0027] Figure 10 This is a schematic diagram of the outer frame in a bent state in Embodiment 2 of the present invention;

[0028] Figure 11 This is a schematic diagram of the mesh deformation on the second sidewall in Embodiment 2 of the present invention;

[0029] Figure 12 This is a schematic diagram of the mesh deformation on the first sidewall in Embodiment 2 of the present invention;

[0030] Figure 13 For the present invention Figure 8 Enlarged schematic diagram of the structure at point A in the diagram;

[0031] Figure 14 For the present invention Figure 9 Enlarged schematic diagram of the structure at point B in the diagram;

[0032] Figure 15 For the present invention Figure 9 Enlarged schematic diagram of the structure at point C;

[0033] Figure 16 This is a schematic diagram showing the unfolded state of the membrane and tubular body after they are connected in Embodiment 2 of the present invention;

[0034] Figure 17 This is a schematic diagram of the internal skeleton in Embodiment 3 of the present invention;

[0035] Figure 18 This is a schematic diagram of the cooperation structure between the lumen support and the main support in Embodiment 4 of the present invention. Detailed Implementation

[0036] 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.

[0037] 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.

[0038] Example 1

[0039] This embodiment provides a lumen stent, such as Figure 2 , Figure 3 As shown, the lumen support includes a tubular body and a membrane 130. The tubular body includes an inner skeleton 110 and an outer skeleton 120 sleeved on the inner skeleton 110. The membrane 130 is disposed on the inner skeleton 110, and the outer skeleton 120 is used to form a protective layer on the outside of the membrane 130.

[0040] It is worth noting that the luminal stent in this embodiment can be used for endovascular treatment of aortic arch aneurysms and for the treatment of thoracic and abdominal aortic aneurysms. Specifically, the luminal stent in this embodiment can serve as a branch stent in chimney techniques. For example, in one embodiment, the luminal stent is arranged side-by-side with the main stent within the arterial lumen, with the end of the luminal stent furthest from the arterial lumen connected to a branch vessel. In another embodiment, the luminal stent can also serve as a branch stent in in-situ fenestration techniques. In other embodiments, this luminal stent can be used in any scenario requiring the coordinated use of multiple stents.

[0041] like Figure 2 , Figure 3 As shown, the tubular body includes an inner skeleton 110 and an outer skeleton 120, with the outer skeleton 120 fitted onto the inner skeleton 110. The outer skeleton 120 and the inner skeleton 110 can be hooked, bonded, or connected by a membrane 130. The membrane 130 covers the inner skeleton 110 to form a tubular structure, allowing the inner skeleton 110 and the membrane 130 to cooperate to form a sealed channel. It is understood that in one embodiment, the membrane 130 can also cover the outer skeleton 120. It is understood that in another embodiment, in the released state, the inner diameter d1 of the outer skeleton 120 is larger than the outer diameter d2 of the inner skeleton 110. In other embodiments, the inner diameter d1 of the outer skeleton 120 can also be equal to or smaller than the outer diameter d2 of the inner skeleton 110, meaning the outer skeleton 120 has a certain degree of deformability to fit onto the inner skeleton 110.

[0042] The material of the coating 130 can be a biodegradable or non-biodegradable material. For example, the material of the coating 130 can be polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyurethane (PU), or biodegradable polylactic acid (PLA), etc.

[0043] In this embodiment, as Figure 3 As shown, the inner frame 110 includes a plurality of wave-shaped rings 111, which are spaced apart along the axial direction of the inner frame 110. The film 130 covers the wave-shaped rings 111 to achieve the connection between two adjacent wave-shaped rings 111.

[0044] In this embodiment, as Figure 2 , Figure 3 As shown, the outer skeleton 120 has a mesh structure and is woven from braided filaments. The outer skeleton 120 is located outside the inner skeleton 110. The axial ends of the outer skeleton 120 are connected to the wave-shaped rings 111 on the inner skeleton 110. For example, in one embodiment, the axial ends of the outer skeleton 120 are bonded to the covering film 130 by a connecting film 131, thereby achieving the connection between the outer skeleton 120 and the inner skeleton 110. It is understood that in another embodiment, the crests of the wave-shaped rings 111 on the axial ends of the inner skeleton 110 are exposed, and the outer skeleton 120 hooks onto the exposed crests. It is understood that in other embodiments, the covering film 130 includes an inner covering film and an outer covering film. The inner covering film is connected to the inner sidewall of the inner skeleton 110, and the outer covering film is connected to the outer sidewall of the inner skeleton 110. A notch is provided on the outer covering film, through which the outer skeleton 120 connects to the wave-shaped rings 111.

[0045] The advantage of this arrangement is that, by fitting the outer frame 120 onto the inner frame 110, the outer frame 120 is positioned outside the membrane 130. When the main support 700 rubs against the lumen support, especially in the gap between two adjacent corrugated annular structures 111, the membrane 130 is easily damaged by friction from the main support 700 in this area because it is unsupported. At this time, the outer frame 120 can form a barrier on the outside of the membrane 130, preventing the main support 700 from rubbing against the membrane 130, thereby protecting the membrane 130.

[0046] It is understood that, in another embodiment, such as Figure 4 As shown, the inner skeleton 210 can also be formed by cutting metal. The inner skeleton 210 has a spring-like spiral structure. The outer skeleton 220 is woven from braided filaments to form a mesh structure. The outer skeleton 220 is connected to the inner skeleton 210 through a connecting membrane 231. The membrane 230 covers the inner skeleton 210.

[0047] It is understood that in other embodiments, such as Figure 5 As shown, the inner skeleton 320 includes at least one braided filament, which is woven to form a mesh structure. The membrane 330 covers the inner skeleton 320. The outer skeleton 310 has a mesh structure and is fitted onto the inner skeleton 320. The outer skeleton 310 is connected to the inner skeleton 320.

[0048] Example 2

[0049] The difference between this example and Embodiment 1 is that, as Figures 6 to 9 As shown, the outer frame 420 has a mesh structure. The outer frame 420 includes a first sidewall 421 and a second sidewall 422. When the outer frame 420 is in a bent state, the first sidewall 421 is the large bend side 140 and the second sidewall 422 is the small bend side 150. When the outer frame 420 is in a natural state, the area S1 of the smallest mesh on the first sidewall 421 is smaller than the area S2 of the smallest mesh on the second sidewall 422.

[0050] In this embodiment, as Figure 7 As shown, the inner skeleton 410 includes a first section 411, a second section 412, and a third section 413; wherein, the first section 411, the third section 413, and the outer skeleton 420 are woven together by braiding filaments to form a mesh structure, and the second section 412 includes a plurality of wave-shaped rings 4121 spaced apart along the axial direction of the inner skeleton 410.

[0051] In this embodiment, as Figure 7 As shown, the outer frame 420 is woven from braided filaments to form a mesh structure. The filaments can hook together or simply intersect and overlap. The mesh openings on the outer frame 420 refer to the openings formed by the intersection of multiple filaments. The outer frame 420 includes a bent state and a natural state. In its natural state, the outer frame 420 is a vertical tubular structure. The first sidewall 421 and the second sidewall 422 are arranged opposite each other. The first sidewall 421 and the second sidewall 422 can be spaced apart along the circumference of the outer frame 420 or continuous in the circumference, such as... Figure 8 , Figure 9 As shown in the unfolded diagram of the exoskeleton 420, the smallest mesh size (i.e., mesh area S1) on the first sidewall 421 is smaller than the smallest mesh size (i.e., mesh area S2) on the second sidewall 422. Specifically, the ratio of the mesh area S1 on the first sidewall 421 to the mesh area S2 on the second sidewall 422 is 1.5 to 4, specifically, this ratio can be 1.5, 2, 3, or 4. Figure 10 As shown, in the bent state, the outer frame 420 has an arc-shaped tubular structure. At this time, the outer frame 420 includes a large bending side 140 and a small bending side 150. The first sidewall 421 is located on the large bending side 140, and the second sidewall 422 is located on the small bending side 150.

[0052] It is worth explaining that you should refer to this again. Figure 1 and Figure 10 One end of the branch stent 100 is inserted into the main stent 700, and the other end of the branch stent 100 is inserted into the branch vessel. The middle section of the branch stent 100 exhibits a large bending angle. At this point, if... Figure 11 As shown (the solid line portion in the figure is a schematic diagram of the mesh of the second sidewall 422 in the vertical state, and the dashed line portion is a schematic diagram of the mesh state of the second sidewall 422 after deformation), on the small bend side 150 of the tube support, the braided wires on the outer skeleton 120 move towards each other and overlap, reducing the mesh area and thus making the braided wires at the small bend side 150 more dense; on the large bend side 140 of the branch support 100, as Figure 12 As shown in the figure (the solid line part is a schematic diagram of the mesh of the first sidewall 421 in the vertical state, and the dashed line part is a schematic diagram of the mesh state of the first sidewall 421 after deformation), the braided wires on the outer frame 120 move in opposite directions, making the braided wires at the large bending side 140 relatively sparse. At this time, a large area of ​​mesh is formed at the large bending side 140. At the same time, when bending, the film 130 is easy to adhere to the mesh of the large bending side 140 under its own elastic force, which makes the film 130 of the large bending side 140 easy to be damaged by the friction of the main support 700.

[0053] The advantage of this arrangement is that, in the bent state, the first sidewall 421 is located on the large bend side 140. The braided filaments on the first sidewall 421 move in opposite directions under the pull of both ends of the inner skeleton 410, increasing the mesh area on the first sidewall 421. By setting the mesh area on the first sidewall 421 to be smaller than the mesh area on the second sidewall 422 in the natural state, the mesh area on the first sidewall 421 still has sufficient braided filament density to form a barrier on the outside of the coating 430, ensuring the protection of the coating 430 at the large bend side 140. The second sidewall 422 is located on the small bend side 150. The braided filaments on the second sidewall 422 move towards each other under the compression of both ends of the inner skeleton 410, decreasing the mesh area on the second sidewall 422. At this time, even if the mesh area on the second sidewall 422 is larger than the mesh area on the first sidewall 421 in the natural state, the outer skeleton 420 can still maintain sufficient braided filament density to achieve protection of the coating 430 at the small bend side 150.

[0054] Furthermore, in the bent state, to ensure a certain gap between the large bending side 140 of the outer frame 420 and the membrane 430, such as... Figures 11 to 13 As shown, the second sidewall 422 is connected to the inner frame 410, and at least one part of the first sidewall 421 is suspended to form a free end.

[0055] In this embodiment, please continue to refer to Figure 11 as well as Figure 13The two ends of the outer skeleton 420 are connected to the first segment 411 and the third segment 413 respectively. The two ends of the first sidewall 421 are spaced apart from the membrane 430. The outer skeleton 420 is suspended outside the inner skeleton 410 to form a free end. This free end means that the two ends of the first sidewall 421 are not constrained by the inner skeleton 410 or the membrane 430. For example, in this embodiment, the two ends of the first sidewall 421 are not connected to the first segment 411 and the third segment 413. Thus, at the two ends of the first sidewall 421, the force transmission effect between the first sidewall 421 and the inner skeleton 410 is interrupted or weakened.

[0056] It is worth explaining that at the first sidewall 421, the mesh area is smaller and the braided filaments are denser, thus making the deformation resistance of the first sidewall 421 greater than that of the second sidewall 422. When the middle section of the inner skeleton 410 bends, the first sidewall 421 will pull on the inner skeleton 410, increasing the difficulty of bending the inner skeleton 410 and reducing its deformation resistance. Here, deformation resistance refers to the ease with which the inner skeleton 410 bends; the better the deformation resistance, the easier the inner skeleton 410 is to bend, and the worse the deformation resistance, the more difficult the inner skeleton 410 is to bend.

[0057] Thus, the connection between the outer frame 420 and the inner frame 410 is achieved through the connection of the second sidewall 422 and the inner frame 410. By suspending at least one end of the first sidewall 421 to form a free end, the force transmission between the first sidewall 421 and the inner frame 410 is interrupted or weakened at both ends of the first sidewall 421. On the one hand, the interference of the first sidewall 421 on the bending deformation of the inner frame 410 is reduced, increasing the flexibility of the inner frame 410. On the other hand, when the inner frame 410 bends and deforms, the first sidewall 421 is subjected to a weaker pulling force from the inner frame 410, making the bending degree of the first sidewall 421 less than that of the inner frame 410. This creates a certain gap between the first sidewall 421 and the membrane 430, allowing space for the first sidewall 421 to be deformed under pressure, and reducing the probability of the main support 700 contacting the membrane 430.

[0058] Furthermore, to avoid excessive tension on the first sidewall 421 caused by the inner skeleton 410, resulting in an excessively large mesh area, such as... Figure 9 , Figure 14 and Figure 15 As shown, the outer frame 420 is formed by braiding filaments. The braiding filaments on the first sidewall 421 are interlocked with each other, and the axially adjacent crests and troughs formed by the braiding filaments on the second sidewall 422 do not interfere with each other.

[0059] In this embodiment, the outer skeleton 420 includes a first braided yarn and a second braided yarn. The first braided yarn is woven and then heat-set to form a first waveform structure 423. The second braided yarn is woven and then heat-set to form a second waveform structure 424. The first waveform structure 423 includes a first trough 4231, and the second waveform structure 424 includes a second peak 4241. Figure 14 As shown, in the region where the first sidewall 421 is located, the braided threads at the second crest 4241 pass through the inside of the first trough 4231 and then fold towards the outside of the second crest 4241 to achieve interlocking of the braided threads; as Figure 15 As shown, in the region where the second sidewall 422 is located, the second peak 4241 is located inside or outside the first valley 4231. The second peak 4241 is in contact with the first valley 4231, and the second peak 4241 and the first valley 4231 do not interfere with each other.

[0060] In another embodiment, in the region where the first sidewall 421 is located, when the second peak 4241 crosses the first trough 4231, it is wound multiple times around the first trough 4231 to increase the connection stability between the first trough 4231 and the second peak 4241. In other embodiments, in the region where the first sidewall 421 is located, the highest point of the second peak 4241 is welded to the lowest point of the first trough 4231.

[0061] The advantage of this design is that when the outer frame 420 bends and deforms along with the inner frame 410, the first sidewall 421 is located on the large bend side 140. The braided wires on the first sidewall 421 move in opposite directions under the pull of both ends of the inner frame 410. When the braided wires move in opposite directions to a certain distance, the braided wires on the first sidewall 421 hook each other to limit the displacement of the braided wires moving in opposite directions. This constrains the maximum mesh area of ​​the first sidewall 421 in the bending state, and prevents the mesh area of ​​the first sidewall 421 in the bending state from being too large, which would expose the film 430 and weaken the protective effect of the outer frame 420 on the film 430.

[0062] Furthermore, such as Figure 6 , Figure 7 As shown, the inner skeleton 410 includes a first segment 411, a second segment 412 and a third segment 413. The second segment 412 is more flexible than the first segment 411 and the third segment 413. The outer skeleton 420 is located at least outside the second segment 412.

[0063] like Figure 7As shown, the second segment 412 includes multiple wave-shaped rings 4121, which are spaced apart along the axial direction of the second segment 412. In its natural state, the axes of all the wave-shaped rings 4121 are on the same straight line as the axes of the first segment 411 and the third segment 413. Two adjacent waveform rings 4121 are spaced apart. Exemplarily, the waveform rings 4121 include a first waveform ring 4121a and a second waveform ring 4121b. The first waveform ring 4121a includes a first end face located at the end of the first waveform ring 4121a near the second waveform ring 4121b. The second waveform ring 4121b includes a second end face located at the end of the second waveform ring 4121b near the first waveform ring 4121a. A spaced distance d3 exists between the first and second end faces, which is -3 to 5 mm; specifically, the spaced distance d3 can be -3, -1, 0, 2, or 5 mm.

[0064] In this embodiment, as Figure 11 As shown, the first segment 411, the third segment 413, and the outer skeleton 420 are woven together from braided yarns. The first segment 411, the third segment 413, and the outer skeleton 420 form a mesh structure. The first segment 411 and the third segment 413 are located at the two ends of the axial direction of the outer skeleton 420, respectively. The inner diameter of the first segment 411 and the third segment 413 is smaller than the inner diameter of the outer skeleton 420. The mesh area on the first segment 411 and the third segment 413 can be the same or different. In the natural state, the axes of the first segment 411, the third segment 413, and the outer skeleton 420 are on the same straight line.

[0065] like Figure 16 As shown, the membrane 430 includes an inner membrane 431 and an outer membrane 432. The inner membrane 430 is located inside the first segment 411, the second segment 412, and the third segment 413, and covers the inner walls of the first segment 411, the second segment 412, and the third segment 413, so that the inner skeleton 410 forms a sealed channel. The outer membrane 432 includes a first outer membrane 4321, a second outer membrane 4322, and a third outer membrane 4323. The first outer membrane 4321 covers the outer wall of the first segment 411, the second outer membrane 4322 covers the outer wall of the second segment 412, and the third outer membrane 4323 covers the outer wall of the third segment 413. After the outer membrane 430 covers the first segment 411, the second segment 412, and the third segment 413, the outer skeleton 420 is located on the outer wall of the second outer membrane 4322, thereby achieving protection for the second outer membrane 4322.

[0066] Therefore, when the inner skeleton 410 is bent, the second segment 412 includes multiple wave-shaped rings 4121. The multiple wave-shaped rings 4121 are spaced apart so that they do not interfere with each other, making the second segment 412 easier to bend. As a result, it has better flexibility and can still maintain a good circular lumen in the bent state, ensuring the smooth flow of blood.

[0067] It is worth explaining that the compliance test method for the inner skeleton 410 can be performed according to the bending / folding section D.5.3.6 in Appendix D of YY / T0663.2-2016 "Cardiovascular Implants - Endovascular Devices - Part 2: Vascular Stents". For example, in one embodiment, the luminal stent is placed in a straight tube, and the straight tube with the stent is placed on a cylindrical diameter gauge to test the stent orientation under the worst-case scenario; the catheter with the stent is wound around the gauge so that the entire length of the stent can be detached from the gauge, or bent up to 180°; the radius is recorded, and whether severe stenosis is observed; the force applied to the stent is removed, and whether the stent can return to its initial geometry is recorded; the radius of the gauge is gradually reduced, and the radius and the occurrence of severe folding are repeatedly recorded until folding occurs or the stent diameter is reduced by 50%.

[0068] Furthermore, please refer to... Figure 16 The first outer film 4321, the second outer film 4322 and the third outer film 4323 are arranged at intervals.

[0069] It should be noted that the first outer film 4321 covers the outer wall of the first segment 411. There is a gap between the first outer film 4321 and the second outer film 4322, separating the outer film 432 at the junction of the first segment 411 and the second segment 412. Similarly, there is a gap between the second outer film 4322 and the third outer film 4323, separating the outer film at the junction of the third segment 413 and the second segment 412. Thus, by spaced apart the first and second outer films 4321 and 4322, and by spaced apart the second and third outer films 4322, gaps are created between them. This prevents the outer film 432 from covering the outer frame 420, thereby increasing the flexibility of the outer frame 420.

[0070] Furthermore, to facilitate the compression of the tubular support into the conveying device, such as... Figure 16 As shown, the intersection point p of the braided threads on the outer frame 420 is located between two adjacent wave-shaped loops 4121. For example, in one embodiment, a plurality of wave-shaped loops 4121 are spaced apart, and a space for accommodating the intersection point p of the braided threads is formed between two adjacent wave-shaped loops 4121.

[0071] Therefore, when the stent needs to be compressed into the delivery device for delivery to the target location via the blood vessel, the intersection point p of the braided wires on the outer skeleton 420 is located between two adjacent wave-shaped rings 4121, so that a space for the braided wire intersection point p can be formed between the two adjacent wave-shaped rings 4121. This allows for maximum utilization of the space on the second segment 4121 and reduces the difficulty of compressing the stent into the delivery device.

[0072] Furthermore, to help staff identify the location of the curved section, please refer to... Figure 6 , Figure 7 The lumen stent also includes multiple developing structures 440, which are respectively disposed at both ends of the second segment 412. It should be noted that the developing structures 440 are made of developing material, such as tantalum, platinum, or gold, which have good developing effects. Each developing structure 440 includes a developing wire wound around a wave-shaped ring 4121 at both ends of the second segment 412. In other embodiments, developing material is welded onto the wave-shaped ring 4121 at both ends of the second segment 412. Therefore, by providing developing structures 440 at both ends of the second segment 412, the position of the outer skeleton 420 can be identified during stent release, making it easier for operators to identify which position is more suitable for use with other stents.

[0073] Thus, when the lumen stent is used in conjunction with the main stent 700, bending usually occurs at the second section 412, and the area that usually rubs against the main stent 700 also occurs at the second section 412. The greater flexibility of the second section 412 allows it to maintain a good circular lumen even when bent, ensuring smooth blood flow. The outer skeleton 420 only covers the middle section 412, so the outer skeleton 420 does not need to completely cover the inner skeleton 410, thereby reducing the coverage area of ​​the outer skeleton 420 and reducing the difficulty of compressing and loading the lumen stent into the delivery device.

[0074] In other embodiments, such as Figure 17As shown, the first segment 511, the second segment 512, and the third segment 513 each include multiple spaced-apart waveform loops. The waveform phases of adjacent waveform loops on the first segment 511 and the third segment 513 are opposite, while the waveform phases of adjacent waveform loops on the second segment 512 are the same. For example, in one embodiment, the second segment 512 includes a first waveform loop and a second waveform loop. The first waveform loop includes a first peak 5121 and a first trough 5122, and the second waveform loop includes a second peak 5123 and a second trough 5124. The first peak 5121 and the second peak 5123 are located on the same vertical line, and the first trough 5122 and the second trough 5124 are located on the same vertical line, thereby making the waveform phases of adjacent waveform loops on the second segment 512 the same. The first segment 511 includes a third waveform loop and a fourth waveform loop. The third waveform loop includes a third peak 5111 and a third trough 5112, and the fourth waveform loop includes a fourth peak 5113 and a fourth trough 5114. The third peak 5111 and the fourth trough 5114 are positioned opposite each other, and the third trough 5112 and the fourth peak 5113 are positioned opposite each other, thus making the waveform phases of two adjacent waveform loops on the first segment 511 opposite. The third segment 513 includes a fifth waveform loop and a sixth waveform loop. The fifth waveform loop includes a fifth peak 5131 and a fifth trough 5132, and the sixth waveform loop includes a sixth peak 5133 and a sixth trough 5134. The fifth peak 5131 and the sixth trough 5134 are positioned opposite each other, and the fifth trough 5132 and the sixth peak 5133 are positioned opposite each other, thus making the waveform phases of two adjacent waveform loops on the third segment 513 opposite. Therefore, by having the same waveform phase on the wave-shaped rings on the second segment 512, a larger gap is created between the two adjacent wave-shaped rings, providing a certain displacement space for the two adjacent wave-shaped rings, thus giving the second segment 512 better flexibility. By setting the waveform phases of the two adjacent wave-shaped rings on the first segment 511 and the third segment 513 to be opposite, when the inner frame 510 bends, the two adjacent wave-shaped rings interfere with each other, thus giving the first segment 511 and the third segment 513 better bending resistance.

[0075] Example 4

[0076] This embodiment provides a support system, such as Figure 18 As shown, the stent system includes a luminal stent 600 and a main stent 800 as described above. The main stent 600 and the luminal stent 800 are arranged side by side. One end of the luminal stent 600 is bent towards the branch vessel. The exoskeleton is at least partially attached to the outer wall of the main stent. Therefore, the exoskeleton can reduce or eliminate the friction between the main stent and the endovascular membrane, thereby protecting the endovascular membrane and preventing it from rupturing under the friction of the main stent, which could cause endoleak.

[0077] In another embodiment, the main support 800 has a through hole, and the lumen support 600 is inserted into the through hole and at least partially located on the outside of the main support 800. The outer frame of the lumen support 600 is fitted against the sidewall of the through hole. Because the lumen support includes an inner frame and an outer frame, and the outer frame is located on the outside of the membrane, the outer frame can protect the membrane and prevent it from cracking under friction from the main support, thus preventing internal leakage.

[0078] 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.

[0079] 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, It includes a tubular body and a membrane. The tubular body includes an inner skeleton and an outer skeleton. The membrane is disposed on the inner skeleton, and the outer skeleton is sleeved on the inner skeleton. The outer skeleton is connected to the inner skeleton and is used to form a protective layer on the outside of the membrane. The outer frame has a mesh structure and includes a first sidewall and a second sidewall. When the outer frame is in its natural state, the area of ​​the smallest mesh hole on the first sidewall is smaller than the area of ​​the smallest mesh hole on the second sidewall. When the outer frame is in a bent state, the first sidewall is the large bend side and the second sidewall is the small bend side.

2. The lumen stent according to claim 1, characterized in that, The second sidewall is connected to the inner skeleton, and at least one part of the first sidewall is suspended to form a free end.

3. The lumen stent according to claim 1, characterized in that, The outer skeleton is woven from braided wires, with the braided wires on the first sidewall hooking together, and the two adjacent peaks and troughs formed by the braided wires on the second sidewall not interfering with each other in the axial direction.

4. The lumen stent according to claim 1, characterized in that, The inner skeleton includes a first segment, a second segment, and a third segment, with the second segment located between the first and third segments, and the second segment having better flexibility than the first and third segments. The outer skeleton covers the second segment.

5. The lumen stent according to claim 4, characterized in that, The second segment includes multiple wave-shaped rings, which are spaced apart along the axial direction of the second segment.

6. The lumen stent according to claim 5, characterized in that, The waveform ring includes peaks and troughs, with the peaks of two axially adjacent waveform rings located on the same straight line, and the troughs of two axially adjacent waveform rings located on the same straight line.

7. The lumen stent according to claim 5, characterized in that, The intersection of the braided wires on the outer skeleton is located between two axially adjacent wave-shaped loops in the second segment.

8. The lumen stent according to claim 4, characterized in that, The first segment, the outer skeleton, and the third segment are integrally woven together, and the outer diameters of the first segment and the third segment are smaller than the outer diameter of the outer skeleton.

9. The lumen stent according to claim 4, characterized in that, The lumen support also includes two imaging structures, which are respectively disposed at both ends of the second segment.