Lumen stent and stent system

Abstract

The present application is suitable for the field of medical devices, and provides a lumen stent, which comprises a main stent, at least two legs connected to an axial end of the main stent, and a support structure connected to the axial end of the main stent, the support structure being located between two adjacent legs, and the length of the support structure being adjustable. The lumen stent provided by the present application is provided with the support structure connected to the main stent and located between two adjacent legs, and the length of the support structure is adjustable, so that when there is a gap at the intersection of the main stent and the blood vessel after the lumen stent is implanted in the blood vessel, the support structure can move away from the main stent after being lengthened, and then the support structure can extend towards the intersection of the blood vessel and abut against the intersection of the blood vessel, so that the lumen stent can obtain stable support of the human body's own blood vessel structure, offset the scouring pressure of the blood flow on the intersection of the main stent and the leg, and avoid displacement of the lumen stent or scraping of the blood vessel caused by movement of the anchor.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, and particularly relates to a lumen stent and stent system. Background Technology

[0002] like Figure 1 As shown, typically, for a stent placed at the junction of a blood vessel (W), the junction of the main stent (X) and branch stents (B1, B2) usually has a large displacement space (H). Under the scouring effect of blood flow in blood vessel X and the obstruction effect of the junction itself, the blood flow forms pressure on the stent towards the junction. On the one hand, this can easily cause stent displacement and endoleak. On the other hand, the stent usually has anchoring stents, which are also prone to displacement and scratching of the inner wall of the blood vessel due to the traction of the stent. Summary of the Invention

[0003] The purpose of this invention is to provide a luminal stent and stent system, which aims to solve the technical problem that existing stents are prone to displacement under blood flow.

[0004] The present invention is implemented as follows: a lumen stent, comprising:

[0005] The main support, at least two legs connected to one axial end of the main support, and a support structure connected to one axial end of the main support, the support structure being located between two adjacent legs, and the length of the support structure being adjustable.

[0006] Optionally, the support structure includes an elastic deformable member and a wall-mounted member. One end of the elastic deformable member is connected to one axial end of the main support, and the other end of the elastic deformable member is connected to the wall-mounted member. One end of the elastic deformable member can drive the wall-mounted member to move toward the side away from the main support.

[0007] Optionally, the elastic deformable member includes a mesh structure, with opposite side walls of the mesh structure respectively abutting against two adjacent legs. When the mesh structure is squeezed by the two adjacent legs, one end of the mesh structure connected to the wall abutting member moves toward the side away from the main support.

[0008] Optionally, the width of the mesh structure increases from the end closer to the main support to the end farther away from the main support.

[0009] Optionally, the elastic deformable member includes a strip-shaped member, which forms multiple corners along the length of the support leg. At least two adjacent corners are connected to different support legs, and the two ends of the strip-shaped member are connected to the main support and the wall-mounted member, respectively.

[0010] Optionally, the angle of the corner decreases along the length of the support leg.

[0011] Optionally, the sidewall of the leg protrudes at least partially radially outward, the protrusion being positioned corresponding to the location of the support structure, and the protrusion being located on the side of the leg away from the support structure.

[0012] Optionally, the support leg includes a plurality of annular waveform structures spaced apart along the axial direction. The annular waveform structure includes a first region and a second region. The first region is in contact with the support structure, and the stiffness of the first region is less than that of the second region.

[0013] Optionally, the diameter of the wave rod in the first region is smaller than the diameter of the wave rod in the second region, or the wave width in the first region is greater than the wave width in the second region, or the number of wave peaks in the first region is less than the number of wave peaks in the second region.

[0014] Optionally, the elastic deformable element is helical.

[0015] Optionally, the support structure includes a spiral structure, which comprises a plurality of spiral units connected end to end, the diameter of which increases from the end closer to the main support to the end farther away from the main support.

[0016] Optionally, the elastic deformable member or the spiral structure includes a first state and a second state. When the elastic deformable member or the spiral structure switches from the first state to the second state, one end of the elastic deformable member or the spiral structure moves away from the main support.

[0017] Optionally, the elastic deformable element or helical structure is controlled by its own temperature change to deform from the first state to the second state, and the deformation temperature point of the elastic deformable element or helical structure is greater than or equal to the temperature of human blood.

[0018] Optionally, the elastic deformable element or helical structure is made of a single-pass shape memory material.

[0019] The present invention also provides a support system, including a conveyor, the conveyor including a sheath, a push rod passing through the sheath, and the aforementioned lumen support, wherein a heating element is provided on the push rod and / or the sheath, the lumen support is loaded inside the sheath, and the heating element is used to heat the support structure to cause deformation of the support structure.

[0020] The luminal stent provided by this invention, by setting a main stent and at least two legs connected to the main stent, allows the luminal stent to be implanted at the vascular junction. When there is a gap between the main stent and the vascular junction, a support structure connected to the main stent and located between two adjacent legs is provided, and the length of the support structure can be increased. This allows the extended support structure to move away from the main stent, and thus extend towards the vascular junction and abut against the junction of the main and branch vessels. This provides the luminal stent with stable support from the body's own vascular structure, counteracting the scouring pressure of blood flow at the junction of the main stent and the legs, and preventing the luminal stent from shifting or causing the anchor to move and scratch the blood vessel under the scouring pressure of blood flow. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of a prior art luminal stent provided by the present invention inside a blood vessel;

[0022] Figure 2 This is a schematic diagram of the support structure of the luminal stent provided in Embodiment 1 of the present invention when it is in a blood vessel and the structure is not deformed.

[0023] Figure 3 yes Figure 2 An enlarged view of point A in the diagram;

[0024] Figure 4 This is a schematic diagram of a support structure provided in Embodiment 1 of the present invention;

[0025] Figure 4a This is a schematic diagram of another support structure provided in Embodiment 1 of the present invention;

[0026] Figure 5 This is a schematic diagram of the lumen stent provided in Embodiment 1 of the present invention when the support structure deforms and abuts against the junction of the blood vessel in the blood vessel.

[0027] Figure 6 yes Figure 5 An enlarged schematic diagram of part B in the diagram;

[0028] Figure 7 This is a schematic diagram showing that the diameter of the wave rod in the area where the annular waveform structure and the mesh structure of the leg are attached is smaller than the diameter of the wave rod in the non-attached area, according to Embodiment 1 of the present invention.

[0029] Figure 8 This is a schematic diagram showing that the wave width of the area where the annular waveform structure and the mesh structure of the leg are attached is greater than the wave width of the non-attached area, according to Embodiment 1 of the present invention.

[0030] Figure 9This is a schematic diagram showing that the number of peaks in the region where the annular waveform structure and the mesh structure of the leg are attached is less than the number of peaks in the non-attached region, according to Embodiment 1 of the present invention.

[0031] Figure 10 This is a schematic diagram of the luminal stent provided in Embodiment 2 of the present invention when the support structure is not deformed in the blood vessel;

[0032] Figure 11 This is a schematic diagram of the lumen stent provided in Embodiment 2 of the present invention, showing the deformation of the support structure and its contact with the blood vessel when the stent is inside the blood vessel;

[0033] Figure 12 This is a schematic diagram of the support structure provided in Embodiment 2 of the present invention;

[0034] Figure 13 This is a schematic diagram of the deformation of the support structure when the luminal stent provided in Embodiment 3 of the present invention is in a blood vessel;

[0035] Figure 14 yes Figure 13 Enlarged view of point C in the diagram;

[0036] Figure 15 This is a schematic diagram of the support structure provided in Embodiment 3 of the present invention;

[0037] Figure 16 This is a schematic diagram of the support system provided in Embodiment 4 of the present invention;

[0038] Figure 17 This is a schematic diagram of the lumen support provided in Embodiment 4 of the present invention being installed on the push rod of the conveyor;

[0039] Figure 18 This is a schematic diagram of a push rod with a heating element provided in Embodiment 4 of the present invention.

[0040] Figure label:

[0041] 100. Lumen stent; 10. Main stent; 11. Fixation structure; 20. Leg; 201. Protrusion; 22. Annular waveform structure; 22a. First region; 22b. Second region; 221a. Wave rod; 221b. Wave rod; 222a. Wave crest; 222b. Wave crest; 30. Support structure; 31. Elastic deformation element; 311. Mesh structure; 3111. Mesh unit; 312. Strip; 3121. Corner; 32. Adhesive element; 34. Helical structure; 341. Helical unit; 40. Cover; 41. Inner cover; 42. Outer cover; 50. Anchor; 600. Stent system; 60. Delivery device; 61. Sheath; 62. Push rod; 63. Heating element; X. Main trunk vessel; Y. Branch vessel; W. Vessel junction; D1. Wave width; D2. Wave width Detailed Implementation

[0042] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0043] It should be noted that when a component is referred to as "fixed to" or "set on" another component, it can be directly on the other component or may have an intervening component present. When a component is referred to as "connected to" another component, it can be directly connected to the other component or may have an intervening component present.

[0044] It should also be noted that the directional terms such as left, right, up, and down used in this embodiment are only relative concepts or references to the normal use of the product, and should not be considered restrictive. In this embodiment, the end of the stent from which blood flows in is defined as the proximal end, and the end from which blood flows out is defined as the distal end.

[0045] Example 1

[0046] like Figures 2 to 6 The diagram shown is a schematic diagram of the lumen support provided in Embodiment 1 of the present invention.

[0047] The lumen stent 100 includes a main stent 10, at least two legs 20 connected to the distal end of the main stent 10, and a support structure 30 connected to the distal end of the main stent 10. The support structure 30 is located between two adjacent legs 20, and the length of the support structure 30 is adjustable.

[0048] The main stent 10 includes a fixing structure 11 and a covering 40. The covering 40 is disposed on the inner wall and / or outer wall of the fixing structure 11 to form a lumen through which blood can flow. The fixing structure 11 may be formed by weaving or cutting shape memory alloy material. The fixing structure 11 may include a wave-shaped ring structure or a mesh structure and has a certain degree of elasticity. For example, in one embodiment, the fixing structure 11 includes multiple wave-shaped rings arranged along the axial direction of the main stent 10, and the covering 40 is connected to the multiple wave-shaped rings to form a lumen structure. The support leg 20 includes a supporting frame and a covering (not shown in the figure). The covering covers the supporting frame to form a lumen, and the support leg 20 communicates with the lumen inside the main stent 10.

[0049] When the luminal stent 100 is placed in the human body, the main stent 10 is located in the main blood vessel X, and the legs 20 are located in the branch blood vessels Y. The number of legs 20 can be set according to the number of branch blood vessels Y. For example, in this embodiment, there are two branch blood vessels Y, and correspondingly, there are two legs 20. Along the axial direction of the main stent 10, the main stent 10 has one end near the legs 20 and one end away from the legs 20. The end of the main stent 10 near the legs 20 can be connected to the end of the legs 20 near the main stent 10 through a covering 40, that is, the covering 40 of the main stent 10 and the covering 40 of the legs 20 can be directly connected. It can be understood that in other embodiments, the covering on the main stent 10 can be integrally connected with the covering on the legs 20, or they can be connected by means of adhesion, suturing, etc.

[0050] The support structure 30 is connected to the end of the main support 10 near the support leg 20 (i.e., the distal end). After each support leg 20 is connected to the main support 10, there is a certain gap between each support leg 20, and the support structure 30 is located between two adjacent support legs 20. The length of the support structure 30 can be adjusted. It can be understood that the end of the support structure 30 away from the support (i.e., the distal end) can extend and lengthen towards the side away from the main support 10. For example, the support structure 30 can be a helical spring structure, and the helical spring structure is made of shape memory material. Utilizing the characteristics of shape memory material, the helical spring structure can extend towards both ends of the axial direction after reaching a certain temperature point.

[0051] In this way, by setting up the main stent 10 and at least two legs 20 connected to the main stent 10, the lumen stent 100 can be implanted at the vascular junction W. When there is a gap between the main stent 10 and the vascular junction W, the support structure 30 connected to the main stent 10 and located between two adjacent legs 20 is set up, and the length of the support structure 30 can be adjusted to increase. After the support structure 30 is lengthened, it can move towards the distal end, thereby allowing the support structure 30 to extend towards the vascular junction W and abut against the junction of the main trunk vessel X and the branch vessel Y. Thus, the lumen stent 100 can obtain stable support from the human body's own vascular structure, counteract the scouring pressure of blood flow on the junction of the main stent 10 and the legs 20, and prevent the lumen stent 100 from shifting or causing the anchor 50 to move and scratch the blood vessel under the scouring pressure of blood flow. Its beneficial effect is that by placing the support structure 30 at the position of the main stent 10 close to the leg 20, the intersection of the main stent 10 and the leg 20 can quickly abut against the blood vessel intersection W to obtain support after the support structure 30 is deformed.

[0052] See also Figures 4 to 6The support structure 30 includes an elastic deformable member 31 and a wall-adhering member 32. One end of the elastic deformable member 31 is connected to one axial end of the main support 10, and the other end of the elastic deformable member 31 is connected to the wall-adhering member 32. One end of the elastic deformable member 31 can drive the wall-adhering member 32 to move toward the side away from the main support 10.

[0053] One end of the elastic deformable member 31 is connected to the end of the main support 10 near the leg 20, and the other end away from the main support 10 is connected to the wall-adhesive member 32. The elastic deformable member 31 has an axial elastic force and its length can be adjusted. The length of the support structure 30 is adjusted by adjusting the length of the elastic deformable member 31. The wall-adhesive member 32 is used to abut against the blood vessel junction W. The wall-adhesive member 32 is an arc-shaped structure and can be made of biocompatible medical materials (for example, it can be an arc-shaped structure formed by nickel-titanium mesh). When the support structure 30 abuts against the blood vessel junction W, the arc surface of the wall-adhesive member 32 abuts against the blood vessel junction W.

[0054] It is understood that in this embodiment, the elastic deformation member 31 includes a mesh structure 311. The opposite side walls of the mesh structure 311 are respectively attached to two adjacent legs 20. When the mesh structure 311 is squeezed by the two adjacent legs 20, the end of the mesh structure 311 connected to the wall-attaching member 32 moves toward the side away from the main support 10.

[0055] The mesh structure 311 can be woven from braided yarns, which are fixedly connected at their intersections. The mesh structure 311 includes multiple mesh units 3111, which can be rhomboid, shuttle-shaped, or similar shapes. Each mesh unit 3111 can expand and elongate towards both ends, allowing the length of the elastic deformable member 31 to be adjusted. The mesh structure 311 has an undeformed natural state and a deformed form. When the mesh structure 311 deforms from its natural state to its deformed form, the two ends of each mesh unit 3111 extend and elongate in opposite directions, increasing the axial distance between the two ends of each mesh unit 3111.

[0056] It is understood that in one embodiment, when the mesh structure 311 is squeezed by two adjacent legs 20, both the left and right sides of the mesh structure 311 are squeezed. At this time, the mesh structure 311 will deform, and the two ends of the mesh unit 3111 will extend in opposite directions. The distance between the two ends of the mesh unit 3111 is stretched, the overall length of the mesh structure 311 becomes longer, and the end of the mesh structure 311 connected to the wall-mounted member 32 moves toward the side away from the main support 10.

[0057] The mesh structure 311 allows the elastic deformable member 31 to adjust the distance between its two ends along the axis. After the lumen stent 100 is implanted into the human body, the elastic deformable member 31 deforms under pressure, allowing the support structure 30 to extend toward the side closer to the leg 20 until the wall-mounted member 32 abuts against the junction W of the blood vessel. This ensures that the lumen stent 100 will not easily shift even if it is subjected to blood flow.

[0058] See Figure 4 , Figure 5 In its natural state, the width of the mesh structure 311 increases from the end closer to the main support 10 to the end farther away from the main support 10.

[0059] The width of the mesh structure 311 refers to the length x1 between the intersection point of the leftmost braided wire of the leftmost mesh unit 3111 and the intersection point of the rightmost braided wire in the radial direction of the support leg 20. In this embodiment, the mesh structure 311 can be formed by connecting multiple mesh units 3111 end to end along the axial direction of the main support 10. Each mesh unit 3111 has its own width, and the width of the mesh unit 3111 farther away from the main support 10 is wider than the width of the mesh unit 3111 closer to the main support 10, such as... Figure 4 As shown, Figure 4 The mesh structure 311 shown in the embodiment has three grid cells whose widths increase progressively from the end furthest from the wall-mounted member 32 to the end closest to the wall-mounted member 32. It is worth noting that the increasing width of the mesh structure 311 from the end closest to the main support 10 towards the end furthest from the main support 10 can refer to a gradual increase, or it could mean that the width of the grid cells first increases, then the width of the middle grid cells remains constant, and finally increases again. As long as there is a tendency for the width of the mesh structure 311 to increase from the end closest to the main support 10 towards the end furthest from the main support 10, it is acceptable. It should be noted that the natural state refers to the state where the mesh structure 311 is not compressed, or the first state described later.

[0060] Since there is a certain gap between adjacent legs 20 after the stent 100 is implanted in the human body, and the gap gradually increases from the end closer to the main stent 10 to the end farther away from the main stent 10, by making the width of the mesh structure 311 increase from the end closer to the main stent 10 to the end farther away from the main stent 10, the mesh structure 311 can better adapt to the change in the gap between the legs 20, so that the side end of the mesh structure 311 always keeps in close contact with the legs 20, and ensures that the mesh structure 311 can always be squeezed by the legs 20.

[0061] Therefore, by connecting one end of the elastic deformable member 31 to the main support 10 and the other end to the wall-adhesive member 32, the wall-adhesive member 32 can move together when the length of the elastic deformable member 31 changes, so as to adjust the overall length of the support structure 30. By setting the wall-adhesive member 32 to abut against the blood vessel wall, the contact area at the junction W of the support structure 30 and the blood vessel can be increased, thereby enhancing the stability of the support structure 30 after it is attached to the blood vessel wall. Furthermore, by setting the wall-adhesive member 32 to be an arc-shaped structure, it can not only fit more tightly against the blood vessel wall, but also allow the support structure 30 to abut against the blood vessel wall with a relatively smooth contact surface, avoiding direct contact with the blood vessel wall with a sharp end and puncturing the blood vessel wall.

[0062] In other embodiments, as Figure 4 Alternative embodiments of the elastic deformable element 31, such as Figure 4a As shown, the elastic deformable member 31 may include a strip 312, which forms multiple corners 3121 along the length of the support leg 20. At least two adjacent corners 3121 are connected to different support legs 20 respectively, and the end of the strip 312 away from the main support 10 is connected to the wall-mounted member 32.

[0063] The number of strips 312 is not limited, and its minimum number can be as follows: Figure 4a Only one is shown. One end of the strip 312 is connected to the main support 10, and the other end is connected to the wall-mounted component 32. The strip 312 is formed by multiple rod-like structures connected end-to-end at an angle. Adjacent rod-like structures intersect to form corners 3121. The strip 312 has multiple corners 3121 along the length of the support leg 20. Two adjacent corners 3121 are connected to different support legs 20, as shown... Figure 4a As shown in the figure, the left corner 3121 and the right corner 3121 are alternately arranged. The left corner 3121 can be connected to one leg 20, and the right corner 3121 in the figure is connected to the other leg 20. When there are two strips 312, the two strips 312 can be arranged parallel or intersecting. When the two strips 312 are intersecting, they can form a shape like... Figure 4 The mesh structure 311 in the illustrated embodiment. It can be understood that the corner 3121 in this embodiment is not necessarily an angled structure. In some other embodiments, the corner 3121 can also be an arc-shaped structure, with the inflection point of the arc-shaped structure forming the vertex of the corner, and the convex surface of the arc-shaped structure connected to the support leg 20.

[0064] By configuring the elastic deformable member 31 to include a strip 312, the strip 312 forms multiple corners 3121 along the length direction of the support leg 20, and two adjacent corners 3121 are connected to different supports 20 respectively. Similarly, the elastic deformable member 31 can be deformed when the opposite sides are squeezed by two adjacent supports 20, so as to achieve the purpose of adjusting the length of the elastic deformable member 31. In this way, the elastic deformable member 31 can extend and lengthen towards the side away from the main stent 10, and the wall-adhesive member 32 connected to the elastic deformable member 31 can abut against the blood vessel wall.

[0065] The angle of corner 3121 decreases along the length of the outrigger 20.

[0066] Along the length of the support leg 20, the angle of the corner 3121 is larger the closer it is to the main stent 10, and the angle of the corner 3121 is smaller the farther it is from the main stent 10. The arrangement of the corners 3121 is also relatively denser. Correspondingly, the bar-shaped structure of the strip 312 is relatively denser the farther it is from the main stent 10, and its elastic force is relatively greater, so that the wall-mounted member 32 can be stably abutted against the junction of the blood vessel W.

[0067] See Figure 3 , Figure 6 The sidewall of the outrigger 20 has at least a portion of a protrusion 201 that faces radially outward. The protrusion 201 is positioned corresponding to the support structure 30 and is located on the side of the outrigger 20 away from the support structure 30.

[0068] The inner side of the support leg 20 is in contact with the support structure 30. The sidewall of the support leg 20 protrudes radially outward to form a protrusion 201. This protrusion 201 may be formed at a local location on the radially outer side of the support leg 20, or the support leg 20 may protrude radially outward throughout its entire outer side. When the support leg 20 protrudes radially outward in a localized area, the protrusion 201 formed by this protrusion is positioned opposite to the support structure 30, and the protrusion 201 is located on the side of the support leg 20 away from the support structure 30 in the radial direction. It can be understood that, in one embodiment, the protrusion 201 can be formed by providing a filling material between the inner and outer layers of the coating, or it can be formed by bending the fixing structure 11 near this location radially outward.

[0069] By providing a protrusion 201 at a certain position on the side wall of the outrigger 20, and the protrusion 201 being provided corresponding to the position of the support structure 30, the outrigger 20 can effectively compress the support structure 30 located inside the outrigger 20 through the protrusion 201 after the lumen stent 100 is released after being implanted into the human body, causing the support structure 30 to deform.

[0070] See Figure 5 , Figure 7The outrigger 20 includes a plurality of annular wave structures 22 spaced apart along the axial direction. The annular wave structure 22 includes a first region 22a and a second region 22b. The first region 22a is in contact with the support structure 30, and the stiffness of the first region 22a is less than that of the second region 22b.

[0071] The first region 22a is the area where the annular waveform structure 22 is in contact with the supporting structure 30, and the second region 22b is the area where the annular waveform structure 22 is not in contact with the supporting structure 30. The stiffness of the first region 22a is less than that of the second region 22b. It can be understood that stiffness refers to the ability of a material or structure to resist elastic deformation when subjected to force. The greater the stiffness, the more difficult it is for the material or structure to deform. That is, in this embodiment, the deformation resistance of the first region 22a is less than that of the second region 22b. In other words, when the first region 22a and the second region 22b are simultaneously compressed, the supporting structure 30 on the first region 22a is more likely to deform. This purpose can be achieved by weakening the structure at the position where the annular waveform structure 22 is in contact with the supporting structure 30. In this embodiment, the deformation resistance of the stent is obtained by flat plate compression. Specifically, in an environment of 30℃~37℃, the stent is compressed with a flat plate, and the compression pressure when the stent is compressed by 50% is measured sequentially at the first region 22a and the second region 22b. It can be found that the pressure at the first region 22a is less than the pressure at the second region 22b, thus the deformation resistance of the first region 22a is less than that of the second region 22b. In other embodiments, the deformation resistance can also be tested by any one of the following methods from 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. It is understood that, in another embodiment, the pressure at the first region 22a can be obtained by pressing the annular waveform structure 22a on the first region 22a with a force gauge until the annular waveform structure 22a is compressed by 50%; the pressure at the second region 22b can also be obtained by pressing the annular waveform structure 22a on the second region 22b with a force gauge until the annular waveform structure 22a is compressed by 50%.

[0072] By setting the stiffness of the first region 22a to be less than that of the second region 22b, the first region 22a is more likely to deform to adapt to the setting of the support structure 30 after the lumen support 100 is loaded. This can reduce the stress of the lumen support 100 after loading and improve the stability of the lumen support 100 when it is released.

[0073] See Figures 7 to 9The diameter of the wave rod 221a at the first region 22a is smaller than the diameter of the wave rod 221b at the second region 22b, or the wave width D1 at the first region 22a is greater than the wave width D2 at the second region 22b, or the number of wave crests 222a at the first region 22a is less than the number of wave crests 222b at the second region 22b.

[0074] like Figure 7 As shown, the annular waveform structure 22 is a ring structure formed by the intersection of multiple wave rods, creating multiple peaks and troughs. Its structure is similar to a ring-shaped sine wave. The diameter of the wave rod 221a in the first region 22a is smaller than the diameter of the wave rod 221b in the second region 22b. This means that the wave rod 221a in the first region 22a is thinner than the wave rod 221b in the second region 22b, and the wave rod in the second region 22b is relatively thicker. Therefore, when manufactured using the same material, the stiffness of the wave rod 221a in the first region 22a is weaker than that of the wave rod 221b in the second region 22b. It can also be understood that the diameter of the wave rod 221a can refer to the width of the wave rod.

[0075] like Figure 8 As shown, the fact that the wave width D1 at the first region 22a is greater than the wave width D2 at the second region 22b means that on the same radial plane, the distance D1 between two adjacent wave troughs at the first region 22a is greater than the distance D2 between two adjacent wave troughs at the second region 22b. It can be understood that the distance D1 between two adjacent wave crests at the first region 22a is greater than the distance D2 between two adjacent wave crests at the second region 22b. That is, correspondingly, the density of wave rods 221a in the first region 22a is relatively sparse, so the overall structural stiffness of the first region 22a is weaker than that of the second region 22b.

[0076] like Figure 9 As shown, the crests and troughs of the annular waveform structure 22 are alternately arranged. The number of crests 222a in the first region 22a is less than the number of crests 222b in the second region 22b. This means that the number of crests 222a in the first region 22a is less than the number of crests 222a in the second region 22b. Since the number of crests in the first region 22a is relatively small, the radial distance between adjacent wave rods is larger. Therefore, the overall structural stiffness of the first region 22a is weaker than that of the second region 22b. Of course, other technical means can also be used to weaken the structural stiffness of the first region 22a, as long as the stiffness of the first region 22a is less than that of the second region 22b.

[0077] By making the diameter of the wave rod 221a at the first region 22a smaller than the diameter of the wave rod 221b at the second region 22b, or the wave width D1 at the first region 22a greater than the wave width D2 at the second region 22b, or the number of wave peaks 222a at the first region 22a less than the number of wave peaks 222b at the second region 22b, the overall structural stiffness at the first region 22a can be made weaker than the structural stiffness at the second region 22b. This achieves the effect of structurally weakening the first region 22a where the annular waveform structure 22 and the supporting structure 30 are attached, thereby making the stiffness of the first region 22a less than the stiffness of the second region 22b.

[0078] Elastic deformation component 31 is made of one-pass shape memory material. One-pass shape memory alloys possess the ability to recover their shape after appropriate heat treatment. Metals deform under external force, and this deformation is classified as elastic deformation and plastic deformation. Elastic deformation occurs when the external force is small, with only a slight change in interatomic spacing, and the metal can recover its original shape after the force is removed. Plastic deformation occurs when the external force exceeds a certain critical value, causing severe crystal deformation that cannot be recovered. There are two types of plastic deformation: one is shearing caused by crystal dislocation slip, and the other is twinning deformation or stress-induced martensitic phase transformation. Shape memory alloys belong to the thermoelastic martensitic phase transformation category. When a shape memory alloy deforms in the martensitic state, it can recover its original shape without external force after heating, and the shape remains unchanged upon cooling again. This shape memory phenomenon is called the one-pass shape memory effect. One-pass shape memory materials include one-pass nickel-titanium based shape memory alloys, copper-based shape memory alloys, or iron-based shape memory alloys. This embodiment uses a nickel-titanium-based shape memory alloy for single-pass shape memory processing as an example: the NiTi alloy material is fully annealed at a high temperature above 800°C, then shaped and processed at room temperature, and then held at 200-300°C for several minutes to tens of minutes. In other embodiments, single-pass shape memory alloys can also be obtained through processes such as medium-temperature treatment and aging treatment.

[0079] After the lumen stent 100 is installed in the human body and the elastic deformable member 31 is deformed and extended to a suitable length, the length of the support structure 30 has been adjusted to the required length in the body. It is necessary to maintain this extension effect to ensure that the support structure 30 will not be affected by the temperature of the blood and will return to its original state. The support structure 30 is made of a single-pass shape memory material, which can meet the requirement that the support structure 30 will not return to its original state after deformation and extension due to the influence of blood.

[0080] The elastic deformable member 31 includes a first state and a second state. When the elastic deformable member 31 switches from the first state to the second state, the distal end of the elastic deformable member 31 moves away from the main support 10.

[0081] The first state is the natural state of the elastic deformable member 31 before deformation, which is the parent state. In the first state, the elastic deformable member 31 is not triggered and therefore will not deform. Figure 2 The diagram shows a space between the support structure 30 and the blood vessel junction W when the elastic deformable member 31 is not deformed. When the elastic deformable member 31 is triggered to deform, it forms a second state, which is a deformed state. During the deformation from the first state to the second state, the end of the elastic deformable member 31 near the support leg 20 moves away from the main support 10, that is, the overall axial length of the support structure 30 increases. The elastic deformable member 31 drives the wall-adhesive member 32 to move towards the side closer to the support leg 20 until the wall-adhesive member 32 abuts against the blood vessel junction W. Figure 5 The diagram shows the support structure 30 abutting against the junction W of the blood vessel after the elastic deformable member 31 deforms. That is, the purpose of the deformation of the elastic deformable member 31 is to adjust the length of the support structure 30. The length adjustment of the support structure 30 is achieved by the elastic deformable member 31 being able to deform, so as to facilitate the adjustment of the lumen stent 100 in the blood vessel.

[0082] The elastic deformable element 31 is controlled by its own temperature change to deform from the first state to the second state. The deformation temperature of the elastic deformable element 31 is greater than or equal to the temperature of human blood.

[0083] The elastic deformable component 31 is made of a single-pass shape memory alloy material. Its deformation can be triggered by temperature changes, and it can be heated to trigger deformation. Since it is implanted inside the blood vessels of the human body, its lowest deformation temperature is higher than the normal human body temperature, which is typically 36-37℃. Of course, the human body temperature may rise and change due to external stimuli or internal diseases and infections, or there may be slight differences in temperature between different individuals. Therefore, the deformation temperature of the elastic deformable component 31 can also be higher than the normal human body temperature range.

[0084] The deformation temperature of the elastic deformable element 31 is greater than or equal to the human body temperature. This allows the elastic deformable element 31 to be heated externally to trigger its deformation, making the deformation controllable according to treatment needs and allowing for length adjustment based on individual circumstances. If the deformation temperature of the elastic deformable element 31 is lower than the human body temperature, the human body will spontaneously transfer its own heat to the elastic deformable element 31 due to the heat transfer effect, potentially causing uncontrolled deformation. In such cases, the deformation amount of the elastic deformable element 31 and the length of the supporting structure 30 cannot be adjusted according to actual clinical needs. Therefore, the deformation temperature of the elastic deformable element 31 must be greater than or equal to the human body temperature.

[0085] See Figure 2 The lining 40 includes an inner lining 41, which is located inside the main support 10 and the legs 20. Figure 2 In some embodiments, only an outer liner may be provided, which is located on the outside of the main support 10 and the legs 20. The lumen stent 100 may be provided with only an inner liner 41 or an outer liner, or both an inner liner 41 and an outer liner may be provided on the inside and outside of the main support 10 and the legs 20.

[0086] Both the inner and outer cladding films can be made of materials such as polytetrafluoroethylene, polyester, polyester fiber, and polyurethane, and are flexible. They can be fixed to the fixing structure 11 by means of heat pressing, sewing, etc. After the inner and outer cladding films are fixed to the fixing structure 11, the inner wall surface of the inner cladding film 41 forms the inner wall of the main support 10, and the outer wall surface of the outer cladding film forms the outer wall surface of the main support 10. At this time, the main support 10 has a double-layer cladding structure. After the inner cladding film 41 is fixed to the inner wall of the main support 10, and the outer cladding film covers the outer wall of the main support 10, the inner and outer cladding films are fixed relative to the fixing structure 11, and the outer wall of the inner cladding film 41 and the inner wall of the outer cladding film are adhered and fixed. When only the inner membrane 41 is provided, the fixing structure 11 is located outside the inner membrane 41, and the main support 10 is a single-layer membrane structure. When only the outer membrane is provided, the fixing structure 11 is located inside the outer membrane, and the lumen support 100 is also a single-layer membrane structure.

[0087] See Figure 2 Anchor spikes 50 are provided on the outer side of the main support 10. Multiple anchor spikes 50 can be provided, and multiple anchor spikes 50 can be arranged in a ring at intervals around the main support 10.

[0088] The anchor 50 can be made of the same material as the fixing structure 11. The anchor 50 can be set independently and fixed to the fixing structure 11 of the main stent 10 by welding, crimping, or other methods. Alternatively, it can be formed by leaving a short free end at the end of the fixing structure 11. The anchor 50 can penetrate the blood vessel wall. By setting the anchor 50 on the outside of the main stent 10, the anchoring effect of the lumen stent 100 can be increased, making the lumen stent 100 more stable and less prone to displacement after implantation.

[0089] Example 2

[0090] See Figures 10 to 12 The difference between this embodiment and Embodiment 1 is that the structure of the elastic deformation member 31 is different. In this embodiment, the elastic deformation member 31 is spiral-shaped.

[0091] The spiral-shaped elastic deformable member 31 has an elastic force in the length direction of the support leg 20. One end of the spiral-shaped elastic deformable member 31 is connected to the main support 10, and the other end is connected to the wall-mounted member 32. When the spiral-shaped elastic deformable member 31 is squeezed by the support leg 20 on both sides, the end connected to the wall-mounted member 32 can extend and elongate toward the side away from the main support 10. Figure 10The diagram shows an example of the spiral elastic deformable member 31 without deformation within the luminal stent 100. When no deformation occurs, the support structure 30 has a certain distance from the junction W of the blood vessel. Figure 11 The diagram shows an example of the spiral elastic deformable member 31 deforming within the lumen stent 100. After deformation, the elastic deformable member 31 moves toward the side away from the main stent 10 and moves the wall-adhering member 32 together. After moving, the wall-adhering member 32 abuts against the junction W of the blood vessels, providing support to the support structure 30 through the blood vessel structure of the human body, and also providing support for the lumen stent 100. Thus, when the lumen stent 100 is subjected to blood flow scouring, it can offset the scouring pressure of the blood flow at the junction of the main stent 10 and the leg 20, preventing the lumen stent 100 from shifting under the scouring pressure of the blood flow or moving the anchor 50 and scratching the blood vessels.

[0092] By making the elastic deformable member 31 spiral, the same purpose of adjusting the length of the support structure 30 can be achieved by extending it along the length direction of the leg 20. Of course, the elastic deformable member 31 can also be in other shapes, as long as it can achieve the purpose of changing the length of the support structure 30.

[0093] Example 3

[0094] See Figures 13 to 15 The difference between this embodiment and Embodiment 1 lies in the structure of the support structure 30. The support structure 30 includes a spiral structure 34, which includes multiple spiral units 341 connected end to end. The diameter of the spiral units 341 increases from the end closer to the main support 10 to the end farther away from the main support 10.

[0095] The spiral structure 34 is made of a single-pass shape memory alloy and is connected to the end of the main support 10 near the leg 20. Spiral units 341 are connected end-to-end along the length of the leg 20 to form the spiral structure 34. The connected spiral units 341 form a strip. The number of spiral units 341 is not limited, nor is the number of turns in each spiral unit 341; these can be set according to actual clinical needs. The diameter of the spiral unit 341 refers to the distance between opposite sides along the radial direction of the leg 20. Figure 13 , Figure 14 The diagram shows a schematic of the spiral structure 34 extending towards the side away from the main stent 10, with the end of the spiral structure 34 abutting against the junction W of the blood vessel. Figure 15 The diagram shows an example of a support structure 30 including three spiral units 341. Figure 15The diameter of the spiral unit 341 closest to the main support 10 is D3, the diameter of the spiral unit 341 farthest from the main support 10 is D5, and the diameter of the spiral unit 341 in the middle is D4. The relationship between the diameters of these three spiral units 341 is D5>D4>D3, that is, the diameter of the spiral unit 341 increases from the end closest to the main support 10 to the end furthest from the main support 10.

[0096] By including the spiral structure 34 in the support structure 30, the axial length of the support structure 30 can be adjusted. This allows the support structure 30 to extend further away from the main stent 10, extending towards the vascular junction W and abutting against the junction of the main vessel X and the branch vessel Y. This provides the luminal stent 100 with stable support from the body's own vascular structure, counteracting the scouring pressure of blood flow at the junction of the main stent 10 and the leg 20, and preventing the luminal stent 100 from shifting under the scouring pressure of blood flow. By increasing the diameter of the spiral unit 341 from the end closer to the main stent 10 to the end farther away from the main stent 10, the diameter of the end of the spiral unit 341 farther away from the main stent 10 is larger, increasing the contact area between the spiral unit 341 and the vascular junction, thereby increasing the support effect of the spiral unit 341.

[0097] In this embodiment, the spiral structure 34 also includes a first state when it is not deformed and a second state after deformation. When the spiral structure 34 switches from the first state to the second state, one end of the spiral structure 34 moves away from the main support 10.

[0098] The spiral structure 34 deforms from a first state to a second state under its own temperature change. When it is heated and triggered to deform, it deforms from the first state to the second state. During the deformation process, the end of the spiral structure 34 near the support leg 20 moves away from the main support 10, and the end of the spiral structure 34 abuts against the junction W of the blood vessel. Similarly, in this embodiment, the deformation temperature of the spiral structure 34 is greater than or equal to the temperature of human blood.

[0099] Example 4

[0100] See Figures 16 to 18 This embodiment provides a support system 600, including a conveyor 60. The conveyor 60 includes a sheath 61 and a push rod 62 passing through the sheath 61. The support system 600 also includes the aforementioned lumen support 100. A heating element 63 is provided on the push rod 62. The lumen support 100 is loaded inside the sheath 61. The heating element 63 is used to heat the support structure 30 to cause deformation of the support structure 30. Of course, the heating element 63 can be provided on the push rod 62 or the sheath 61 at the same time, or only on the sheath 61.

[0101] The push rod 62 is movably inserted into the lumen of the sheath 61, and the lumen stent 100 is detachably connected to the push rod 62. Both the lumen stent 100 and the push rod 62 are located within the sheath 61. During the delivery of the lumen stent 100, by controlling the push rod 62 of the delivery device 60, the push rod 62 can slide relative to the sheath 61, thereby delivering the lumen stent 100 fixed on the push rod 62 into the diseased blood vessel. The heating element 63 can be a commercially available heating structure, such as heating by energizing electrodes. The heating element 63 can be located on the push rod 62, on the sheath 61, or simultaneously on both the push rod 62 and the sheath 61, as long as it can raise the temperature of the support structure 30 to trigger its deformation. In this embodiment, Figure 18 The diagram shows a heating element 63 mounted on a push rod 62.

[0102] Heating by the heating element 63 gradually increases the temperature of the elastic deformable element 31 of the support structure 30. When the temperature of the elastic deformable element 31 reaches its deformation temperature point, it deforms. The elastic deformable element 31 drives the wall-adhering element 32 connected to it to extend axially away from the main stent 10 until the wall-adhering element 32 abuts against the junction W of the blood vessel. In this way, the luminal stent 100 is stably fixed in the blood vessel by the structure of the human blood vessel itself, and will not easily shift even if it is subjected to blood flow. It is understandable that the deformed shape of the elastic deformable element 31 may vary for different individuals.

[0103] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A lumen stent, characterized in that: include: The stent comprises a main stent, at least two legs connected to the distal end of the main stent, and a support structure connected to the distal end of the main stent. The support structure is located between two adjacent legs and its length is adjustable. The support structure can extend toward the junction of blood vessels and abut against the junction of the main blood vessel and the branch blood vessel, thereby enabling the luminal stent to obtain stable support from the human body's own vascular structure and counteract the scouring pressure of blood flow at the junction of the main stent and the legs. The support structure includes an elastic deformable element and a wall-adhesive element for conforming to the junction of blood vessels. One end of the elastic deformable element is connected to the distal end of the main stent, and the other end of the elastic deformable element is connected to the wall-adhesive element.

2. The lumen stent as described in claim 1, characterized in that: The elastic deformable member can drive the wall-mounted member to move away from the main support.

3. The lumen stent as described in claim 2, characterized in that: The elastic deformable member includes a mesh structure, and the opposite side walls of the mesh structure are respectively attached to two adjacent legs. When the mesh structure is squeezed by the two adjacent legs, the end of the mesh structure connected to the wall-attaching member moves toward the side away from the main support.

4. The lumen stent as described in claim 3, characterized in that: In its natural state, the width of the mesh structure increases from the end closer to the main support to the end farther away from the main support.

5. The lumen stent as described in claim 2, characterized in that: The elastic deformable member includes a strip-shaped member, which forms multiple corners along the length of the support leg. At least two adjacent corners are connected to different support legs. The two ends of the strip-shaped member are connected to the main support and the wall-mounted member, respectively.

6. The lumen stent as described in claim 5, characterized in that, The angle of the corner decreases along the length of the outrigger.

7. The lumen stent as described in claim 1, characterized in that: The sidewall of the outrigger has at least a portion of a protrusion facing radially outward, the protrusion being positioned corresponding to the support structure and located on the side of the outrigger away from the support structure.

8. The lumen stent as described in claim 1, characterized in that: The outrigger includes multiple annular waveform structures spaced apart along the axial direction. Each annular waveform structure includes a first region and a second region. The first region is in contact with the support structure, and the stiffness of the first region is less than that of the second region.

9. The lumen stent as described in claim 8, characterized in that: The diameter of the wave rod in the first region is smaller than the diameter of the wave rod in the second region, or the wave width in the first region is greater than the wave width in the second region, or the number of wave peaks in the first region is less than the number of wave peaks in the second region.

10. A lumen stent, characterized in that: include: The stent comprises a main stent, at least two legs connected to the distal end of the main stent, and a support structure connected to the distal end of the main stent. The support structure is located between two adjacent legs and its length is adjustable. The support structure can extend toward the junction of blood vessels and abut against the junction of the main blood vessel and the branch blood vessel, thereby enabling the luminal stent to obtain stable support from the human body's own vascular structure and counteract the scouring pressure of blood flow at the junction of the main stent and the legs. The support structure includes a spiral structure, which comprises multiple spiral units connected end to end, and the diameter of the spiral units increases from the end closer to the main support to the end farther away from the main support.

11. The lumen stent as described in claim 1 or 10, characterized in that: Both the elastic deformable element and the spiral structure include a first state and a second state. When the elastic deformable element or the spiral structure switches from the first state to the second state, one end of the elastic deformable element or the spiral structure moves away from the main support.

12. The lumen stent as described in claim 11, characterized in that: The elastic deformable element or helical structure is controlled by its own temperature change to deform from the first state to the second state, and the deformation temperature point of the elastic deformable element or helical structure is greater than or equal to the temperature of human blood.

13. The lumen stent as described in claim 1 or 10, characterized in that: The elastic deformable element or helical structure is made of a single-pass shape memory material.

14. A support system, comprising a conveyor, characterized in that: It also includes a lumen support as described in any one of claims 1 to 13, the lumen support being loaded within the delivery device.

Images