A type of support

Abstract

This utility model relates to the field of medical device technology and discloses a stent, comprising: a stent body having multiple through holes; and at least one reinforcing beam assembly, each of the reinforcing beam assemblies including at least one reinforcing beam disposed within the through holes. This utility model significantly improves radial support force and structural rigidity while maintaining the same total stent material usage by embedding reinforcing beam assemblies within the through holes, rather than simply increasing wall thickness or rod width. This utility model enhances support force through structural optimization rather than material thickening; arranging reinforcing beams within the through holes does not increase the overall thickness of the stent, thereby reducing the risk of foreign body irritation. This utility model uses reinforcing beam assemblies as a localized reinforcement structure, which can improve support force while maintaining the valve opening area, reducing transvalvular pressure gradient, and reducing cardiac load.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, specifically to a stent. Background Technology

[0002] Artificial heart valve stents are core implantable devices for treating valvular heart diseases (such as aortic stenosis). Their radial support force directly affects the post-implantation support of the valve annulus and its long-term stability. If the radial support force of the stent is insufficient after implantation, the stent root cannot be effectively anchored to the root of the native valve annulus, leading to stent displacement or dislodgement. If the stent stiffness is insufficient, the valve cannot fully expand, resulting in a reduced valve opening area, decreased blood flow, and impaired cardiac function. Therefore, improving the radial support force and structural rigidity of the stent is a key research direction for this device.

[0003] Currently, improving the radial support and structural rigidity of stents is often achieved simply by increasing the stent wall thickness and strut width. However, increasing the stent wall thickness and strut width increases the total amount of stent material, leading to an increase in the amount of foreign body in the body after implantation, reducing the product's biocompatibility, and prolonging degradation time. Simultaneously, increasing the wall thickness reduces the valve's inner diameter and effective opening area, resulting in increased resistance to blood flow through the valve, a significant increase in transvalvular pressure gradient, reduced valve function, and increased cardiac workload. Utility Model Content

[0004] In view of this, the present invention provides a stent to solve the problem that current methods of increasing the radial support force and structural rigidity of stents can lead to an increase in the amount of foreign matter in the human body and an increase in the resistance of blood flow through the valve.

[0005] This utility model provides a bracket, comprising:

[0006] The bracket body has multiple through holes.

[0007] At least one set of reinforcing beams, each set of reinforcing beams including at least one reinforcing beam disposed within the through hole.

[0008] The beneficial effects of the aforementioned stent are as follows: This invention significantly improves radial support and structural rigidity while maintaining the same total material usage by embedding reinforcing beams inside the through-hole, rather than simply increasing wall thickness or rod width. This invention enhances support through structural optimization rather than material thickening; arranging reinforcing beams within the through-hole does not increase the overall stent thickness, thus reducing the risk of foreign body irritation. This invention uses reinforcing beams as a localized reinforcement structure, which can improve support while maintaining the valve opening area, reducing transvalvular pressure gradient, and decreasing cardiac workload.

[0009] Furthermore, the reinforcing beam of this invention transforms the original unidirectional force path of the through hole into a multidirectional force network, making the stress distribution more uniform, reducing the local stress peak of the support body, and significantly improving the fatigue life of the support.

[0010] In one alternative embodiment, the support body includes a plurality of grid units, each of which is connected sequentially along the circumferential and / or axial directions.

[0011] In one alternative embodiment, the grid cell includes at least one connecting rod, wherein at least one connecting rod is connected end to end to form a cell ring, and the through hole is formed within the cell ring.

[0012] In one alternative embodiment, at least one of the connecting rods is connected end to end to form the unit ring.

[0013] In one optional embodiment, the grid cell includes multiple connecting rods, and the cell ring formed by the connection and enclosure of each connecting rod is a regular polygon or an irregular polygon, and the intersection of two adjacent connecting rods forms a connection node.

[0014] In one alternative implementation, multiple connection nodes are provided, and the two ends of the reinforcing beam are respectively connected to two adjacent or non-adjacent connection nodes.

[0015] In one alternative embodiment, at least two of the connection nodes are arranged opposite to each other; the two ends of the reinforcing beam are respectively connected to the two opposite connection nodes.

[0016] The beneficial effects of the above technical solution are: by setting reinforcing beams between relative nodes to form a symmetrical support structure, the multi-directional deformation resistance of the closed ring is significantly enhanced.

[0017] In one alternative embodiment, the two ends of the reinforcing beam are respectively connected to two axially arranged connection nodes.

[0018] In one alternative embodiment, one end of the reinforcing beam is connected to a connecting node, and the other end of the reinforcing beam is connected to a connecting rod that is adjacent to or not adjacent to the connecting node.

[0019] The beneficial effects of the above technical solution are: by connecting non-adjacent nodes and connecting rods, an oblique support path is formed, which disperses axial, radial and torsional loads and reduces local stress concentration.

[0020] In one optional embodiment, the two ends of the reinforcing beam are respectively connected to two adjacent connecting rods, and the reinforcing beams of the adjacent connecting rods form local rigid units to enhance the bending resistance of the structure.

[0021] In one alternative embodiment, the two ends of the reinforcing beam are respectively connected to two non-adjacent connecting rods, forming a long-distance support path through the non-adjacent connecting rods across the region, thereby dispersing multi-directional loads.

[0022] In one alternative embodiment, the reinforcing beam is adapted to divide the unit ring into two independent triangular structures, or the reinforcing beam is adapted to divide the unit ring into one independent triangular structure and one independent polygonal structure.

[0023] In one alternative implementation, the unit ring is a notched ring or a closed ring.

[0024] In one alternative embodiment, when the unit ring is a closed ring, the closed ring is rhomboid; the reinforcing beam is adapted to divide the closed ring into two independent triangular structures, or the reinforcing beam is adapted to divide the closed ring into an independent triangular structure and an independent polygonal structure.

[0025] The beneficial effects of the above technical solution are as follows: The closed ring is rhomboid in shape. This design not only increases the contact area between the connecting rods and enhances the connection strength, but also makes the shape of the through holes more regular, which helps to distribute stress evenly in the grid cells. The four vertices of the rhomboid closed ring are formed by the ends of the connecting rods, creating a stable quadrilateral structure and enhancing the overall rigidity of the support. By adding reinforcing beams to connect the nodes in each rhomboid grid, the rhomboid grid has more supporting structures when it deforms under stress, reducing the degree of bending at the head and deformation at the root, and increasing the radial support force; at the same time, the added beams can make the stress evenly distributed, avoid stress concentration, and prevent local damage.

[0026] In one alternative embodiment, the reinforcing beam group includes a plurality of reinforcing beams arranged uniformly or non-uniformly along the circumference of the support body.

[0027] The beneficial effects of the above technical solution are: the circumferentially arranged reinforcing beams form a continuous support ring, which improves the circumferential stiffness of the support.

[0028] In one alternative embodiment, at least one of the reinforcing beams is arranged within the same through hole.

[0029] The beneficial effects of the above technical solution are: one or more reinforcing beams can be arranged in the same through hole, and the strength of the support is greater when more reinforcing beams are arranged in the through hole.

[0030] In one alternative embodiment, each of the reinforcing beams is arranged in a through hole that is not adjacent in the circumferential direction; and / or, each of the reinforcing beams is arranged in a through hole that is adjacent in the circumferential direction.

[0031] In one alternative embodiment, each of the reinforcing beam groups includes at least one reinforcing beam array, the reinforcing beam array being formed by one or more reinforcing beams from the same reinforcing beam group.

[0032] In one alternative implementation, each of the reinforcing beam groups includes multiple reinforcing beam arrays, wherein the number of reinforcing beams in each reinforcing beam array may be the same or different.

[0033] In one alternative embodiment, the reinforcing beam array is formed by at least two reinforcing beams from the same reinforcing beam group, and each of the reinforcing beam arrays is arranged circumferentially on the support body.

[0034] In one optional embodiment, the reinforcing beam array is formed by three reinforcing beams in the same reinforcing beam group, namely a first reinforcing beam, a second reinforcing beam, and a third reinforcing beam; the first reinforcing beam and the second reinforcing beam are respectively arranged in two circumferentially adjacent through holes, and the third reinforcing beam is arranged in the through hole axially adjacent to the first reinforcing beam and the second reinforcing beam, and the third reinforcing beam is located between the first reinforcing beam and the second reinforcing beam in the circumferential direction.

[0035] The beneficial effects of the above technical solution are as follows: the three reinforcing beams form a stable reinforcing area in the region, and this reinforcing area is larger than the reinforcing area formed by arranging a single reinforcing beam in the through hole. This not only enhances the stability of the support in the axial direction, but also forms a more uniform support structure in the circumferential direction, thereby improving the overall mechanical performance and stability.

[0036] In one alternative embodiment, multiple reinforcing beam groups are provided, and each reinforcing beam group is arranged at axial intervals.

[0037] The beneficial effects of the above technical solution are as follows: the axially spaced reinforcing beams can form rigid support nodes at different axial positions of the support. These rigid support nodes can effectively distribute axial loads and prevent the support from local overload or deformation when under stress.

[0038] In one alternative embodiment, the reinforcing beams arranged at axial intervals may be partially the same, partially different, all the same, or all different.

[0039] In one alternative embodiment, the support body is a ring structure.

[0040] In one alternative embodiment, the stent body is an expandable stent having a first configuration that is radially confined during transport and a second configuration that expands radially after release.

[0041] The reinforcing beam is an elastic reinforcing beam, which has a third configuration in an extended state and a fourth configuration in a contracted state; when the support body is in the first configuration, the reinforcing beam is in the third configuration; when the support body is in the second configuration, the reinforcing beam is in the fourth configuration, and the third and fourth configurations of the reinforcing beam are different.

[0042] In one alternative embodiment, the reinforcing beam is arranged in a direction different from the radial direction of the support body.

[0043] In one alternative embodiment, the reinforcing beam is straight, S-shaped, wavy, curved, arc-shaped, V-shaped, X-shaped, or spiral.

[0044] In one optional embodiment, the reinforcing beam does not protrude from the support body in the radial direction. The added reinforcing beam increases the radial support force of the support body without increasing the overall thickness of the support body, thereby reducing the risk of foreign body irritation.

[0045] In one alternative embodiment, the support body has a support root and a support head arranged axially.

[0046] The density of the reinforcing beams on the support body gradually decreases from the root of the support to the head of the support, which makes the root area of ​​the support have higher structural strength and rigidity, and can better anchor to the valve ring to prevent the support from shifting; or, the density of the reinforcing beams on the support body is constant from the root of the support to the head of the support, which is simpler to manufacture and has lower cost. Attached Figure Description

[0047] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0048] Figure 1 A schematic diagram of the structure of the bracket provided by this utility model;

[0049] Figure 2 Another structural schematic diagram of the bracket provided by this utility model;

[0050] Figure 3 A schematic diagram of the grid unit structure of the bracket provided by this utility model;

[0051] Figure 4 A schematic diagram of the first arrangement of the bracket provided by this utility model;

[0052] Figure 5 A schematic diagram of a second arrangement of the bracket provided by this utility model;

[0053] Figure 6 A schematic diagram of a third arrangement of the bracket provided by this utility model;

[0054] Figure 7 This is a schematic diagram illustrating the deformation when the root of an existing stent is pressed.

[0055] Figure 8 This is a schematic diagram illustrating the deformation of the head of an existing stent when it is pressed.

[0056] Figure 9 The figure shows the finite element simulation test results of the bracket of this utility model and the existing bracket.

[0057] Explanation of reference numerals in the attached figures:

[0058] 1. Support body; 11. Support root; 12. Support head; 2. Through hole; 3. Reinforcing beam; 31. First reinforcing beam; 32. Second reinforcing beam; 33. Third reinforcing beam; 4. Grid unit; 41. Connecting rod; 42. Connecting node. Detailed Implementation

[0059] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0060] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the term "radial" refers to the direction perpendicular to the axis of the medical implant; the term "axial" refers to the direction coaxial with the axis of the medical implant; and the term "circumferential" refers to the direction that forms a circle around the axis of the medical implant. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0061] Combination Figures 1 to 6 As shown, according to an embodiment of the present invention, a support is provided, including a support body 1 and a set of reinforcing beams. The support body 1 has a plurality of through holes 2. At least one set of reinforcing beams is provided, and each set of reinforcing beams includes at least one reinforcing beam 3, which is disposed within the through holes 2.

[0062] In this embodiment, by embedding reinforcing beams inside the through hole 2, rather than simply increasing the wall thickness or rod width, the radial support force and structural rigidity are significantly improved while keeping the total material usage of the bracket unchanged.

[0063] Traditional methods increase material usage by increasing wall thickness and rod width, which may trigger inflammation or rejection reactions. This embodiment, however, enhances support through structural optimization rather than material thickening. By arranging reinforcing beams 3 within the through-hole 2, the overall thickness of the support structure is not increased, thereby reducing the risk of foreign body irritation.

[0064] Traditional thickening designs compress the valve's inner diameter, resulting in a reduced orifice area. This embodiment uses a reinforced beam assembly as a localized reinforcement structure, which can increase support while maintaining the valve orifice area, reducing transvalvular pressure gradient and decreasing cardiac workload.

[0065] In addition, the reinforcing beam transforms the original unidirectional force path of the through hole 2 into a multidirectional force network, making the stress distribution more uniform, reducing the local stress peak of the support body, and significantly improving the fatigue life of the support.

[0066] The support body 1 can be a ring structure. The support body 1 can be made of multiple connecting rods interwoven, or made of spring coiling, or directly cut.

[0067] When the stent body 1 is of a braided configuration, in some embodiments, the stent body 1 includes multiple grid units 4. The grid units 4 serve as the smallest unit structure of the stent body. Each grid unit 4 is sequentially connected along the circumferential and / or axial directions to form a ring structure, achieving uniform stress distribution through multi-directional connection paths. The circumferential connection of the grid units ensures the radial symmetry of the ring structure, preventing stent deformation or collapse due to stress concentration in local areas. During cardiac contraction, the circumferential grid units can collectively share the radial pressure, maintaining the stability of the valve opening.

[0068] More specifically, the grid cell 4 includes at least one connecting rod 41, wherein the at least one connecting rod 41 connects and surrounds to form a cell ring, and the through hole 2 is located inside the cell ring. That is, the grid cell 4 can be formed by a single connecting rod 41 or by multiple connecting rods 41. Furthermore, one or more connecting rods 41 can be connected end to end, or they can be not connected end to end, for example, they can be staggered.

[0069] When the grid cell 4 includes a connecting rod 41, the connecting rod 41 can be connected end to end to form a circle, an ellipse or other shapes.

[0070] When the grid cell 4 includes multiple connecting rods 41, the connecting rods 41 are connected sequentially (either end-to-end or not) and the resulting cell ring is a regular polygon or an irregular polygon. The intersection of two adjacent connecting rods 41 forms a connection node 42. It should be noted that the irregular polygon may include polygons with curved corners or polygons with curved sides.

[0071] The unit ring can be a notched ring or a closed ring. When the unit ring is a notched ring, the stent body 1 has a certain degree of elasticity in the radial direction, which can better adapt to blood vessels or valve rings of different diameters. When the unit ring is a closed ring, the stent body 1 exhibits higher structural stability and strength. The closed ring design gives the stent stronger radial support, which can better resist the radial pressure generated during cardiac contraction, thereby maintaining the stability of the valve opening.

[0072] As a specific embodiment, combined with Figure 3 As shown, the closed ring is rhomboid. The reinforcing beam 3 is suitable for dividing the closed ring into two independent triangular structures, or for dividing the closed ring into one independent triangular structure and one independent polygonal structure. The rhomboid shape of the closed ring not only increases the contact area between the connecting rods and enhances the connection strength, but also makes the shape of the through-holes more regular, which helps to distribute stress evenly in the grid cells. The four vertices of the rhomboid closed ring are formed by the ends of the connecting rods 41, creating a stable quadrilateral structure and enhancing the overall rigidity of the stent. Furthermore, the design of the closed ring also considers the elasticity of the stent. During diastole, the closed ring can expand moderately with the opening of the valves to ensure smooth blood flow; during systole, the closed ring can quickly return to its original shape, providing sufficient support and preventing excessive valve closure. This design allows the stent to better adapt to the heart's movement patterns and reduces interference with cardiac function.

[0073] In some embodiments, multiple connecting nodes 42 are provided, and the two ends of the reinforcing beam 3 are respectively connected to two adjacent or non-adjacent connecting nodes 42. When the two ends of the reinforcing beam 3 are connected to two adjacent connecting nodes 42, the middle part of the reinforcing beam 3 can be bent, or the middle part of the reinforcing beam 3 can be connected to a connecting rod 41.

[0074] In some embodiments, at least two connecting nodes 42 are arranged opposite each other. The two ends of the reinforcing beam 3 are respectively connected to the two opposite connecting nodes 42. In this embodiment, by setting reinforcing beams between opposite nodes, a symmetrical support structure is formed, significantly enhancing the multidirectional deformation resistance of the closed ring. For example, in a quadrilateral closed ring, the diagonal reinforcing beam transforms the original quadrilateral structure into two triangles, greatly improving the bending resistance through the stability of the triangles. Similarly, in a hexagonal closed ring, the reinforcing beams connecting opposite nodes can disperse the force direction and avoid local deformation.

[0075] In traditional closed-loop structures without reinforcing beams, stress concentration can easily occur at the nodes due to the intersection of connecting rods, leading to premature failure. In this embodiment, the introduction of reinforcing beams distributes the stress originally concentrated at the nodes to the entire closed-loop structure, reducing the risk of fatigue fracture at the nodes.

[0076] More specifically, the two ends of the reinforcing beam 3 are respectively connected to two axially arranged connection nodes 42, which enhances the axial stability of the support.

[0077] As an alternative embodiment, one end of the reinforcing beam 3 is connected to the connecting node 42, and the other end of the reinforcing beam 3 is connected to the connecting rod 41, which may or may not be adjacent to the connecting node 42. In this embodiment, by connecting non-adjacent nodes and connecting rods, an oblique support path is formed, dispersing axial, radial, and torsional loads and reducing local stress concentration. For example, in a vascular stent, when the stent is subjected to blood flow impact or cardiac pulsation, the reinforcing beam can transfer axial or radial stress to the distal connecting rod, avoiding node breakage caused by stress concentration in one direction.

[0078] As an alternative embodiment, the two ends of the reinforcing beam 3 are respectively connected to two adjacent connecting rods 41, and the reinforcing beams of the adjacent connecting rods form local rigid units to enhance the bending resistance of the structure.

[0079] As an alternative embodiment, the two ends of the reinforcing beam 3 are respectively connected to two non-adjacent connecting rods 41. A long-range support path is formed by the non-adjacent connecting rods across the region, distributing multi-directional loads.

[0080] As an alternative embodiment, within the same through hole 2, reinforcing beams connecting two adjacent connecting rods 41 and reinforcing beams connecting two non-adjacent connecting rods 41 are respectively arranged.

[0081] In some embodiments, the reinforcing beam assembly includes multiple reinforcing beams 3 arranged uniformly or non-uniformly along the circumference of the support body 1, that is, the circumferentially arranged reinforcing beams form a continuous support ring, thereby improving the circumferential stiffness of the support. More specifically, the reinforcing beam assembly includes multiple reinforcing beams arranged uniformly or non-uniformly along the circumference of the support, and the specific arrangement can be set according to the actual situation.

[0082] Combination Figure 4 As shown, each reinforcing beam 3 is arranged within a non-adjacent through hole 2 along the circumferential direction; or, in combination with... Figure 5 As shown, each reinforcing beam 3 is arranged within a circumferentially adjacent through hole 2. That is, in the circumferential direction, one or more reinforcing beams can be arranged every other closed ring, or one or more reinforcing beams can be arranged within each closed ring; alternatively, some reinforcing beams 3 can be arranged within non-adjacent circumferential through holes 2, and some reinforcing beams 3 can be arranged within adjacent circumferential through holes 2. The specific arrangement method and number of reinforcing beams 3 can be selected based on the target radial support strength of the support.

[0083] As an alternative embodiment, each reinforcing beam group includes at least one reinforcing beam array, which is formed by one or more reinforcing beams 3 from the same reinforcing beam group. When each reinforcing beam group includes multiple reinforcing beam arrays, the number of reinforcing beams 3 in each reinforcing beam array may be the same or different.

[0084] When a reinforcing beam array is formed by at least two reinforcing beams 3 from the same reinforcing beam group, each reinforcing beam array is arranged circumferentially on the support body 1, and the reinforcing beam arrays can be spaced apart or closely arranged, depending on the required support effect. The design of the reinforcing beam array, compared with arranging a single reinforcing beam in a through hole, can further improve the load-bearing capacity and stability of the support.

[0085] The reinforcing beam 3 in the reinforcing beam array can be two, three, four or more, as described below. Figure 6 Taking a reinforced beam array comprising three reinforced beams 3 as an example, the specific explanation is as follows: The three reinforced beams 3 are a first reinforced beam 31, a second reinforced beam 32, and a third reinforced beam 33. The first reinforced beam 31 and the second reinforced beam 32 are respectively arranged in two circumferentially adjacent through holes 2, and the third reinforced beam 33 is arranged in a through hole 2 that is axially adjacent to the first reinforced beam 31 and the second reinforced beam 32, and the third reinforced beam 33 is located between the first reinforced beam 31 and the second reinforced beam 32 in the circumferential direction. The three reinforced beams 3 form a stable reinforced area in this region, and this reinforced area is larger than the reinforced area formed by arranging a single reinforced beam in the through hole. This not only enhances the stability of the support in the axial direction, but also forms a more uniform support structure in the circumferential direction, improving the overall mechanical performance and stability.

[0086] In some embodiments, at least one reinforcing beam 3 is arranged within the same through hole 2, meaning that one or more reinforcing beams 3 can be arranged within the same through hole 2. The more reinforcing beams 3 arranged within the through hole 2, the greater the strength of the support. The reinforcing beams within a single through hole can directly support the through hole structure, preventing it from deforming or collapsing under load.

[0087] In some embodiments, the thickness of the reinforcing beam 3 is less than or equal to the thickness of the support body 1. When the reinforcing beam 3 is arranged in the through hole 2, the reinforcing beam 3 does not protrude from the support body 1 in the radial direction. The added reinforcing beam 3 increases the radial support force of the support body 1 without increasing the overall thickness of the support body 1, which can reduce the risk of foreign body irritation.

[0088] In some embodiments, multiple reinforcing beam assemblies are provided, and each reinforcing beam assembly is arranged at axial intervals. The axially spaced reinforcing beam assemblies can form rigid support nodes at different axial positions of the support, and these rigid support nodes can effectively distribute axial loads and prevent local overload or deformation of the support when under stress.

[0089] The reinforcing beam groups arranged at intervals along the axial direction may be partially the same, partially different, all the same, or all different.

[0090] In some embodiments, the stent body 1 is an expandable stent, which can expand on its own after being delivered to the target location, or the stent body 1 can be expanded by ball expansion.

[0091] The stent body 1 has a first configuration that is radially restricted during delivery and a second configuration that expands radially after release, thereby enabling the stent body 1 of this embodiment to serve as an artificial heart valve stent for the treatment of heart valve disease.

[0092] When the stent body 1 is in the first configuration, it is constrained within the delivery catheter and is in a radially compressed state. The grid cells 4 are compressed, and the through-hole 2 is flattened, facilitating delivery to the target site of the heart valve via the vascular pathway. After the stent body 1 is released from the catheter constraint, it automatically expands into the second configuration. Based on its expandable characteristics, the stent body 1 expands radially to the designed diameter, the grid cells 4 unfold into a preset geometric shape (such as a rhombus), and the through-hole 2 returns to its full size, achieving anchoring support for the valve annulus.

[0093] The reinforcing beam 3 is an elastic reinforcing beam, possessing a third configuration in an elongated state and a fourth configuration in a contracted state. When the support is in the first configuration, the reinforcing beam 3 is forcibly stretched by the grid cells 4, storing elastic potential energy internally; at this time, the reinforcing beam 3 is straight or has a low curvature. When the support expands to the second configuration, the reinforcing beam 3 elastically retracts to its designed length, increasing its curvature, and the released elastic potential energy is converted into radial preload, enhancing the rigidity of the support.

[0094] The stent body 1 has a stent root 11 and a stent head 12 arranged axially. The stent root 11 refers to the end of the stent closest to the heart chamber (ventricle or atrium), which is the starting point for blood to flow into the stent. It usually corresponds to the stent's anchoring area and needs to be tightly fitted to the original valve annulus or surrounding tissue to prevent displacement. The stent head 12 refers to the end of the stent furthest from the heart chamber, which is the ending point for blood to flow out of the stent.

[0095] In some embodiments, the density of the reinforcing beams 3 on the stent body 1 gradually decreases from the stent root 11 towards the stent head 12. From the stent root to the stent head, the density of the reinforcing beams decreases linearly or non-linearly, forming a continuous support gradient. This arrangement gives the stent root 11 region higher structural strength and rigidity, enabling better anchoring to the valve annulus and preventing stent displacement. Meanwhile, the stent head 12 region, due to the lower density of the reinforcing beams 3, exhibits better flexibility and adaptability, reducing irritation and damage to surrounding tissues while facilitating smooth blood flow.

[0096] As an alternative embodiment, the arrangement density of the reinforcing beams 3 on the support body 1 is constant from the support root 11 to the support head 12. That is, the arrangement density of the reinforcing beams 3 is consistent throughout the entire support body 1. Although it may be slightly inferior to the aforementioned gradient arrangement in terms of flexibility and adaptability, it is simpler to manufacture and has a lower cost.

[0097] In some embodiments, the reinforcing beam 3 is straight, S-shaped, wavy, curved, arc-shaped, V-shaped, X-shaped, or spiral.

[0098] The following explanation uses a rhombus grid as an example, where the closed loop is rhomboid, to illustrate the above-mentioned support structure.

[0099] The aforementioned support structure increases radial support and structural rigidity by adding reinforcing beams 3 to the rhomboid grid within the support structure, and by varying the distribution and number of these reinforcing beams 3. Specifically, the structural performance is enhanced by dividing the rhomboid grid into more stable triangular structures or other deformations through the addition of reinforcing beams 3. By adding reinforcing beams to connect the nodes within each rhomboid grid, the rhomboid grid receives more support structure when subjected to stress and deformation, reducing the degree of bending at the support head and deformation at the support root, and improving radial support. Simultaneously, the added reinforcing beams ensure even stress distribution, preventing stress concentration and localized damage. Specifically, vertically distributed reinforcing beams are added to the support head, with various designs available for their number and distribution.

[0100] This embodiment improves radial support and structural rigidity without compromising biocompatibility or valve function. Combined with... Figure 9The before-and-after deformation comparison diagram shows that the test results indicate a significant improvement in radial support force and structural rigidity, with minimal deformation of the support diameter, demonstrating excellent resistance to radial compression and structural strength.

[0101] The strength of the above-mentioned support structure is then verified using finite element simulation software.

[0102] Experimental design: Two gripping tests were conducted on the model. Based on the magnitude of the deformation after gripping, it was determined whether the stiffness of the support design was optimized.

[0103] Experimental conditions:

[0104] 1) Simulated gripping tests were conducted on the radial direction of the bottom and top of the support for the two scenarios.

[0105] 2) Apply a force of 10N to the test sites at the root and head of the stent and observe the change in the diameter collapse of the stent. The initial diameter of the stent is 30mm.

[0106] A schematic diagram of pressing and gripping the root of an existing stent can be found here. Figure 7 A schematic diagram illustrating the clamping of the existing stent head can be found here. Figure 8 The test results are as follows: Figure 9 As shown in the test results, the diameter collapse of the support under pressure before the design is greater than that after the design. Therefore, the stiffness of the support after the design is higher, and the effectiveness of the design is verified.

[0107] Since other parallel schemes share the same design principle and have similar support stiffness optimization effects, this verification does not verify each parallel scheme individually.

[0108] Although embodiments of the present invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A stent, characterized by, include: The bracket body (1) has multiple through holes (2). At least one set of reinforcing beams, each set of reinforcing beams including at least one reinforcing beam (3), the reinforcing beam (3) being arranged in the through hole (2).

2. The stent of claim 1, wherein The support body (1) includes multiple grid units (4), and each grid unit (4) is connected sequentially along the circumferential and / or axial directions.

3. The stent of claim 2, wherein, The grid unit (4) includes at least one connecting rod (41), wherein at least one connecting rod (41) is connected to form a unit ring, and the through hole (2) is formed in the unit ring.

4. The stent of claim 3, wherein, At least one of the connecting rods (41) is connected end to end to form the unit ring.

5. The stent defined in claims 3 or 4, wherein, The grid unit (4) includes multiple connecting rods (41). The unit ring formed by the connection of each connecting rod (41) is a regular polygon or an irregular polygon. The junction of two adjacent connecting rods (41) forms a connecting node (42).

6. The stent defined in Claim 5, wherein, Multiple connection nodes (42) are provided, and the two ends of the reinforcing beam (3) are respectively connected to two adjacent or non-adjacent connection nodes (42).

7. The stent defined in Claim 6, wherein, At least two of the connection nodes (42) are arranged opposite to each other; the two ends of the reinforcing beam (3) are respectively connected to the two opposite connection nodes (42).

8. The stent defined in Claim 7, wherein, The two ends of the reinforcing beam (3) are respectively connected to two axially arranged connection nodes (42).

9. The stent of claim 5, wherein, One end of the reinforcing beam (3) is connected to the connecting node (42), and the other end of the reinforcing beam (3) is connected to the connecting rod (41) which is adjacent to or not adjacent to the connecting node (42).

10. The stent defined in Claim 5, wherein, The two ends of the reinforcing beam (3) are respectively connected to two adjacent connecting rods (41); or, the two ends of the reinforcing beam (3) are respectively connected to two non-adjacent connecting rods (41).

11. The stent defined in Claim 5, wherein, The reinforcing beam (3) is adapted to divide the unit ring into two independent triangular structures, or the reinforcing beam (3) is adapted to divide the unit ring into an independent triangular structure and an independent polygonal structure.

12. The stent defined in Claim 3, wherein, The unit ring is a notched ring or a closed ring.

13. The stent defined in Claim 12, wherein, When the unit ring is a closed ring, the closed ring is rhomboid.

14. The stent defined in Claim 1, wherein, The reinforcing beam group includes multiple reinforcing beams (3) arranged uniformly or unevenly along the circumference of the support body (1).

15. The stent defined in Claim 14, wherein, At least one of the reinforcing beams (3) is arranged within the same through hole (2).

16. The stent defined in Claim 14, wherein, Each of the reinforcing beams (3) is arranged in a through hole (2) that is not adjacent in the circumferential direction; and / or, each of the reinforcing beams (3) is arranged in a through hole (2) that is adjacent in the circumferential direction.

17. The stent defined in Claim 14, wherein, Each of the reinforcing beam groups includes at least one reinforcing beam array, which is formed by one or more reinforcing beams (3) in the same reinforcing beam group.

18. The stent defined in Claim 17, wherein, Each of the aforementioned reinforcing beam groups includes multiple reinforcing beam arrays, and the number of reinforcing beams (3) in each reinforcing beam array may be the same or different.

19. The stent defined in Claim 18, wherein, The strong beam array is formed by at least two reinforcing beams (3) in the same reinforcing beam group, and each of the reinforcing beam arrays is arranged circumferentially on the support body (1).

20. The stent defined in Claim 18, wherein, The strong beam array is formed by three reinforcing beams (3) in the same reinforcing beam group, namely the first reinforcing beam (31), the second reinforcing beam (32) and the third reinforcing beam (33); the first reinforcing beam (31) and the second reinforcing beam (32) are respectively arranged in two circumferentially adjacent through holes (2), and the third reinforcing beam (33) is arranged in the through hole (2) that is axially adjacent to the first reinforcing beam (31) and the second reinforcing beam (32), and the third reinforcing beam (33) is located between the first reinforcing beam (31) and the second reinforcing beam (32) in the circumferential direction.

21. The stent of claim 1, wherein, Multiple reinforcing beam groups are provided, and each reinforcing beam group is arranged at intervals along the axial direction.

22. The stent defined in Claim 21, wherein, The reinforcing beam groups arranged at intervals along the axial direction may be partially the same, partially different, all the same, or all different.

23. The stent defined in Claim 1, wherein, The support body (1) has a ring structure.

24. The stent of any of claims 1-4, 6-23, wherein, The support body (1) is an expandable support, having a first configuration that is radially confined during transport and a second configuration that expands radially after release; The reinforcing beam (3) is an elastic reinforcing beam, and the reinforcing beam (3) has a third configuration in an elongated state and a fourth configuration in a contracted state; When the support body (1) is in the first configuration, the reinforcing beam (3) is in the third configuration; when the support body (1) is in the second configuration, the reinforcing beam (3) is in the fourth configuration, and the third configuration and the fourth configuration of the reinforcing beam (3) are different.

25. The stent defined in Claim 24, wherein, The arrangement direction of the reinforcing beam (3) is different from the radial direction of the support body (1).

26. The stent defined in any one of Claims 1-4, 6-23, wherein, The reinforcing beam (3) is straight, S-shaped, wavy, curved, arc-shaped, V-shaped, X-shaped, or spiral.

27. The stent according to any one of claims 1-4 and 6-23, characterized in that, The reinforcing beam (3) does not protrude from the support body (1) in the radial direction.

28. The stent defined in any one of Claims 1-4, 6-23, wherein, The support body (1) has a support root (11) and a support head (12) arranged along the axial direction; The density of the reinforcing beams (3) on the support body (1) gradually decreases from the root (11) of the support to the head (12) of the support; or, the density of the reinforcing beams (3) on the support body (1) remains constant from the root (11) of the support to the head (12) of the support.

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