Artificial implant stent

Abstract

The utility model belongs to the technical field of medical instruments, and particularly relates to an artificial implant support which is provided with a plurality of support connecting holes used for being connected with a valve leaflet mechanism. The bracket connecting hole is a rectangular hole; the artificial implant stent comprises an outflow section, the outflow section comprises a plurality of outflow section frame units and a plurality of outflow section connecting areas, the outflow section frame units are sequentially connected end to end, and the outflow section connecting areas serve as stent connecting parts and are provided with stent connecting holes. The support connecting holes are rectangular holes, compared with a plurality of round holes, sewing of a plurality of circles of sewing lines is easier, and separation of the valve leaflet mechanism and the artificial implant support caused by fracture of the sewing lines is prevented. In addition, the design of the rectangular hole has enough space, so that the connecting piece of the valve leaflet mechanism penetrates out of the outer side of the artificial implant stent from the inner side of the artificial implant stent through the stent connecting hole.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to an artificial implant stent. Background Technology

[0002] The heart is basically divided into the left and right ventricles by the atrioventricular septum. The left ventricle carries arterial blood, which enters the aorta through the aortic valve from the left ventricle. The aorta then transports fresh arterial blood to all parts of the body to provide the body with the necessary oxygen and nutrients. However, because the aortic valve is often subjected to high pressure, various abnormalities such as stenosis and regurgitation occur. Currently, aortic valve disease has become the most common disease among structural heart valves.

[0003] For aortic stenosis, the original aortic valve has a hard calcified area that can serve as a fixation site for artificial heart valves. Currently, there are two main types of valve replacement for aortic stenosis: self-expanding valves and bulbar expansion valves. Due to the strong support of the bulbar expansion valve stent, its valve axis can be designed to be shorter, which can reduce the risk of coronary sinus coverage. The side of the valve close to the left ventricle is also less likely to touch the His bundle, which can better avoid atrioventricular block.

[0004] Chinese patent application 2021111421752 discloses an artificial heart valve. This valve includes a suture section, which is a sheet-like structure, wider in the middle and narrower at both ends, positioned along the axial direction of a stent. The suture section has at least two suture holes, through which the stent and leaflets are connected. This suture section structure is suitable for leaflet mechanisms with clip connections. However, it is not suitable for leaflet mechanisms without clips; therefore, it is necessary to improve the structure of the suture section for connection with the leaflet mechanism. Utility Model Content

[0005] This invention addresses the technical problem that the connection between existing heart valve stents and leaflet mechanisms cannot be applied to leaflet mechanisms without clips, and aims to provide an artificial implant stent.

[0006] To solve the aforementioned technical problems, one aspect of this utility model provides an artificial implant scaffold, wherein the artificial implant scaffold is provided with a plurality of scaffold connection holes for connecting with a leaflet mechanism.

[0007] The characteristic feature is that the bracket connection hole is a rectangular hole;

[0008] The artificial implant scaffold includes:

[0009] An outflow section includes multiple outflow section frame units connected end to end and multiple outflow section connection areas. The outflow section frame unit is a hollow frame unit with outflow section mesh. The outflow section connection area is the area where two adjacent outflow section frame units are connected to each other. Several outflow section connection areas are provided with support connection holes as support connection parts.

[0010] Optionally, in the artificial implant stent as described above, the width of the axial connecting rod of the stent connection portion having the stent connection hole is smaller than the width of the other outflow section connection areas.

[0011] Optionally, in the artificial implant scaffold as described above, the outflow section mesh is a hexagonal mesh.

[0012] Optionally, in the artificial implant stent as described above, the outflow section frame unit includes an upper outflow section protrusion and a lower outflow section protrusion. The upper outflow section protrudes towards the outflow end along the axial direction of the artificial implant stent, and the lower outflow section protrudes away from the outflow end along the axial direction of the artificial implant stent.

[0013] The outflow section frame unit further includes an upper support rod and a lower support rod for the outflow section. The upper support rod for the outflow section is connected between the upper protrusion of the outflow section and the connecting area of ​​the outflow section, and the lower support rod for the outflow section is connected between the lower protrusion of the outflow section and the connecting area of ​​the outflow section.

[0014] When the outflow section connection area is the bracket connection part, two adjacent upper support rods of the outflow section are connected side by side to the middle of the outflow end of the bracket connection part, and two adjacent lower support rods of the outflow section are connected side by side to the middle of the inflow end of the bracket connection part.

[0015] Optionally, in the artificial implant scaffold as described above, the artificial implant scaffold further includes:

[0016] An inflow section is located at the inflow end of the outflow section. The inflow section includes multiple inflow section frame units connected end to end and multiple inflow section connecting areas. The inflow section frame unit is a hollow frame unit with inflow section mesh. The inflow section connecting area is the area where two adjacent inflow section frame units are connected to each other.

[0017] Optionally, in the artificial implant scaffold as described above, the inflow section mesh is a gyroscope-shaped mesh.

[0018] Optionally, in the artificial implant stent as described above, the inflow section frame unit includes an upper inflow section protrusion and a lower inflow section protrusion. The upper inflow section protrudes towards the outflow end along the axial direction of the artificial implant stent, and the lower inflow section protrudes away from the outflow end along the axial direction of the artificial implant stent.

[0019] The inflow section frame unit further includes an upper support rod and a lower support rod. The upper support rod is connected between the upper protrusion of the inflow section and the connecting area of ​​the inflow section, and the lower support rod is connected between the lower protrusion of the inflow section and the connecting area of ​​the inflow section.

[0020] Optionally, in the artificial implant scaffold as described above, the artificial implant scaffold further includes:

[0021] At least one transition section is provided between the inflow section and the outflow section. The transition section includes multiple transition section frame units connected end to end and multiple transition section connection areas. The transition section frame unit is a hollow frame unit with transition section mesh. The transition section connection area is the area where two adjacent transition section frame units are connected to each other.

[0022] Optionally, in the artificial implant scaffold as described above, the radial length of the transition section mesh is smaller than the radial length of the inflow section mesh and the radial length of the outflow section mesh;

[0023] And / or, the axial length of the transition section mesh is less than the axial length of the inflow section mesh and the axial length of the outflow section mesh.

[0024] Optionally, in the artificial implant scaffold as described above, the transition segment frame unit includes an upper transition segment protrusion and a lower transition segment protrusion. The upper transition segment protrudes towards the outflow end along the axial direction of the artificial implant scaffold, and the lower transition segment protrudes away from the outflow end along the axial direction of the artificial implant scaffold.

[0025] The transition section frame unit further includes an upper support rod and a lower support rod. The upper support rod connects the upper protrusion of the transition section and the connection area of ​​the transition section, and the lower support rod connects the lower support rod of the transition section and the connection area of ​​the transition section.

[0026] Optionally, in the artificial implant scaffold as described above, the transition section mesh is a gyroscope-shaped mesh.

[0027] The positive and progressive effects of this utility model are as follows:

[0028] 1. The connecting holes on the artificial implant stent that connect to the leaflet mechanism are rectangular. Compared to multiple circular holes, this significantly increases the number of suture loops during connection, making multi-loop sutures easier to perform. This results in more secure leaflet fixation and avoids stress concentration, effectively extending the leaflet's lifespan. Furthermore, the rectangular hole design provides sufficient space for the connector to pass from the inside of the stent through the connecting hole to the outside.

[0029] 2. When the support connection hole is designed as a rectangular hole, the axial frame bars on both sides of the rectangular hole become narrower. During valve expansion, the axial frame bars of the rectangular hole are prone to become stress concentration points and indent inward, thereby squeezing the artificial leaflet passing through the rectangular hole. To avoid this situation, this utility model connects the support bars at the upper and lower ends of the rectangular hole side by side at the middle of the upper and lower ends of the rectangular hole. This protects the rectangular hole during valve expansion and prevents it from indenting inward and squeezing the internal leaflet.

[0030] 3. The inflow segment and / or transition segment mesh of the artificial implant stent adopts a gyroscope-shaped mesh design. The contact area (axial constraint) between two adjacent gyroscope-shaped structures is small. After the valve expands after implantation in the human body, due to the small axial constraint, a larger expansion diameter can be achieved. The gyroscope-shaped structure is located in the inflow segment and / or transition segment of the valve. When the artificial heart valve is in the closed state, the blood flow from the aorta will have a large impact on the artificial heart valve. The gyroscope-shaped structure can have a larger contact area and friction with the root of the aorta, which can significantly improve the impact resistance of the stent.

[0031] Furthermore, the gyroscopic mesh design of the inflow segment allows the inflow stent to retract significantly towards the aorta after the artificial heart valve expands. This prevents the inflow segment of the artificial heart valve from contacting the His bundle and thus avoiding atrioventricular block. It also reduces the axial dimension of the artificial heart valve after expansion, minimizing the impact on the patient caused by implantation.

[0032] 4. The transition section has smaller mesh openings than the outflow and inflow sections on its upper and lower sides. Smaller mesh openings can provide greater strength.

[0033] In addition, the artificial heart valve is in a contracted state during delivery. When it is delivered to the aortic valve, a high-pressure balloon is used to inflate the stent. During the inflation process, the middle segment mesh has a greater resistance to opening, so the middle segment mesh expands more slowly than the inflow and outflow segments. That is, the expansion process presents a "bone-like" shape that is thick at both ends and thin in the middle. This expansion method can ensure that the artificial heart valve is relatively fixed in position before and after expansion, and there will be no axial displacement during the expansion process, which ensures the accuracy of valve release position. Attached Figure Description

[0034] The disclosure of this utility model will become more apparent with reference to the accompanying drawings. It should be understood that these drawings are for illustrative purposes only and are not intended to limit the scope of protection of this utility model. In the drawings:

[0035] Figure 1(a) is a schematic diagram of one structure of the artificial leaflet of this utility model;

[0036] Figure 1(b) is a schematic diagram of the connection between two adjacent artificial petals of this utility model;

[0037] Figure 1(c) is a partial view of the connection between the leaflet mechanism and the artificial implant scaffold of this utility model;

[0038] Figure 1(d) shows the positional relationship between the artificial petal leaflet and the reinforcing strip edge of this utility model;

[0039] Figure 1(e) is a schematic diagram of the closed state of an artificial valve leaflet without protrusions;

[0040] Figure 2(a) is a schematic diagram of one structure of this utility model;

[0041] Figure 2(b) is the front view of Figure 2(a);

[0042] Figure 2(c) is a magnified view of a portion of Figure 2(b);

[0043] Figure 2(d) is a schematic diagram of the unfolded structure of Figure 2(a);

[0044] Figure 2(e) is a schematic diagram of the stitching state of the inner skirt edge of this utility model;

[0045] Figure 3(a) is a schematic diagram of one unfolded structure of the outer skirt of this utility model;

[0046] Figure 3(b) is a magnified view of part A in Figure 3(a);

[0047] Figure 3(c) is a magnified view of part B in Figure 3(a);

[0048] Figure 4(a) is a schematic diagram of an unfolded structure of the inner skirt of this utility model;

[0049] Figure 4(b) is a schematic diagram of another unfolded structure of the inner skirt of this utility model;

[0050] Figure 5 This is a schematic diagram of the artificial heart valve provided by this utility model. Detailed Implementation

[0051] The following specific examples illustrate the implementation of this utility model. Those skilled in the art can easily understand other advantages and effects of this utility model from the content disclosed in this specification. This utility model can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of this utility model.

[0052] It should be noted that, unless otherwise specified, the following embodiments and features can be combined with each other.

[0053] In the description of this utility model, it should be noted that the directional terms such as "outer side", "middle section", "inner", "outer" indicate the orientation and positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. They should not be construed as limiting the specific protection scope of this utility model.

[0054] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features. Thus, the use of "first" and "second" to define a feature may explicitly or implicitly include one or more of that feature. In the description of this utility model, "several" or "a number" means two or more, unless otherwise explicitly specified.

[0055] In the description of this utility model, it should be noted that the terms "inflow end," "outflow end," "inflow segment," and "outflow segment" used in this utility model are directional terms commonly used in the field of interventional medical devices. "Inflow end" and "inflow segment" indicate that antegrade blood first flows into one end or segment of the interventional medical device, such as the lower end or lower segment in Figure 2(b). "Outflow end" and "outflow segment" indicate that antegrade blood flows out of one end or segment of the interventional medical device, such as the upper end or upper segment in Figure 2(b). "Axial direction" refers to the direction parallel to the line connecting the center of the "inflow end" and the center of the "outflow end," such as the axial direction of the stent in Figure 2(b), which is also the vertical direction. "Radial direction" refers to the direction perpendicular to the aforementioned "axial direction."

[0056] As shown in Figures 1-4, this invention provides an embodiment of an artificial implant stent, hereinafter referred to as stent 100. Stent 100 serves as part of a bulb-expandable artificial heart valve and is connected to its inner leaflet mechanism 200. Stent 100 is a radially contractible or expandable annular stent, which can be expanded using a balloon. A plurality of stent connection holes 140 are provided on stent 100, through which the leaflet mechanism 200 is connected to the inner side of stent 100.

[0057] Reference Figures 1(a) to 1(d) The leaflet mechanism 200 includes several connectors 210 and several artificial leaflets 220. The artificial leaflets 220 are sequentially connected to form a ring-like structure. Preferably, the number of connectors 210 is equal to the number of artificial leaflets 220. More preferably, the number of connectors 210 and artificial leaflets 220 is three each. Each artificial leaflet 220 has a leaflet body 221, two first connecting parts 222, and two second connecting parts 223.

[0058] Two first connecting portions 222 are connected to both sides of the free end of the leaflet body 221, and two second connecting portions 223 are connected above their respective first connecting portions 222, with the connection point being foldable. That is, the second connecting portion 223 can be folded forward (perpendicular to the paper surface) along the first flip axis 223a. The second connecting portion 223 is divided into a fixed portion 2231 on the left and an arc-shaped portion 2232 on the right. The connection point between the fixed portion 2231 and the arc-shaped portion 2232 is foldable, that is, the fixed portion 2231 can be folded relative to the arc-shaped portion 2232 along the second flip axis 223b. The second flip axis 223b divides the second connecting portion 223 into the fixed portion 2231 and the arc-shaped portion 2232. The side of the arc-shaped portion 2232 away from the fixed portion 2231 is an arc-shaped structure 2232a, that is, as shown in Figure 1(a), the right edge of the arc-shaped portion 2232 is an arc-shaped structure 2232a.

[0059] When several artificial leaflets 220 with the same structure are connected in sequence, referring to Figure 1(b), the two first connecting portions 222 of two adjacent artificial leaflets 220 are fixedly connected together by a connector 210. One end of the connector 210 covers the first connecting portion 222 to prevent damage to the leaflets. Several artificial leaflets 220 are connected into a ring. After being folded along the axis of symmetry of the connector, the connector 210 is passed through the corresponding bracket connecting hole 140 from the inside of the bracket 100. The connector 210 located on the outside of the bracket 100 is evenly divided into two parts on both sides of the bracket connecting hole 140 and abuts against the outer periphery of the bracket 100. As shown in Figure 1(c), the second connecting portion 223 is folded outward towards the outside of the overlapping area formed by two adjacent artificial leaflets 220. The arc-shaped portion abuts against the outer wall of the leaflet body 221, and the fixing portion 2231 is folded along the surface perpendicular to the artificial leaflet body and abuts against the connector 210 on the inside of the bracket 100. The two adjacent fixing parts 2231 are respectively connected to the two sides of the connector 210. The fixed state is shown in Figure 1(c), which realizes the fixation between the leaflet mechanism 200 and the bracket 100.

[0060] This invention uses a fixing part 2231 located inside the stent and a connector 210 located outside the stent for fixed connection. After the leaflet mechanism 200 is connected to the stent 100, the arc-shaped part 2232 folded on the side of the fixing part 2231 abuts against the outer wall of the leaflet body 221. Usually, the arc-shaped part 2232 is integrally formed with the artificial leaflet 220. The arc-shaped part 2232 has good flexibility. When the artificial leaflet 220 is open, the arc-shaped part 2232 abutting against the outer wall of the artificial leaflet 220 can provide a certain support force to prevent the artificial leaflet from opening completely. On the one hand, this avoids stress concentration at the connection between the artificial leaflet and the stent, which would reduce the service life of the artificial leaflet. On the other hand, the artificial leaflet not opening completely can prevent it from adhering to the aortic wall and blocking the coronary artery ostium when open. When the artificial valve leaflet is closed, blood from the aorta impacts it. Because the free end of the arc-shaped portion has a certain width, it protects the leaflet at the connection point with the stent, buffering the scouring force of the blood flow and better protecting the artificial valve leaflet 220. Specifically, the right side of the arc-shaped portion 2232 is designed with an arc-shaped structure 2232a, which is more in line with fluid dynamics. When the artificial valve leaflet is closed, the arc-shaped portion can block part of the blood flow impact, preventing the formation of eddies between the arc-shaped portion and the main body of the artificial valve leaflet, or at least reducing eddies. This reduces the blood flow impact on the leaflet and the stent, improving the fatigue life of the stent 100 and increasing the stability of the artificial heart valve after implantation. This is because the stability of the artificial heart valve is one of its important indicators; it is hoped that the valve will remain in its implanted position after implantation, avoiding displacement or even detachment. For artificial heart valves, especially in the pre-endothelialization stage immediately after implantation, a stable stent 100 improves product safety, preventing blood impact from causing valve displacement and surgical failure.

[0061] In some embodiments, the leaflet mechanism 200 includes three connectors 210 and three artificial leaflets 220, which are connected in sequence by the connectors 310 to form a ring structure.

[0062] In some embodiments, two adjacent fixing parts 2231 are respectively stitched together with the two sides of the connector 210. During stitching, the stitching line is fixedly connected to the fixing part 2231 and the connector 210 around the axial frame rod of the bracket connection hole.

[0063] In some embodiments, referring to FIG1(a), a horizontally oriented leaflet U-shaped groove 224 is provided at the connection between the first connecting portion 222 and the second connecting portion 223, and the opening of the leaflet U-shaped groove 224 is an open structure. When the connector 210 extends from the inside of the bracket 100 through the bracket connecting hole 140 to the outside of the bracket 100, it drives the first connecting portion 222 connected to the connector 210 to exert an outward pulling force, and the second connecting portion 223 needs to be bent so that the fixing portion 2231 is located in a position relative to the inside of the connector 210. Through the design of the leaflet U-shaped groove 224, neither the first connecting portion 222 nor the second connecting portion 223 will be damaged when the connector 210 extends or when the fixing portion 2231 bends along the leaflet U-shaped groove 224.

[0064] In this application, "bending" and "folding" both refer to a component flipping along a certain axis.

[0065] In some embodiments, referring to FIG1(a), the outer contour of the fixed end of the leaflet body 221 has a leaflet bottom arc 2211 and two leaflet side arcs 2212. The lower end of the leaflet bottom arc 2211 is an arc-shaped structure. The two leaflet side arcs 2212 are located on both sides of the leaflet bottom arc 2211, and the lower end of the leaflet side arcs 2212 is also an arc-shaped structure. The slopes of the leaflet bottom arc 2211 and the two leaflet side arcs 2212 are equal and smoothly connected to form the fixed end of the artificial leaflet 220.

[0066] When the inner side of the stent 100 is provided with an inner skirt, the lower end of the leaflet body 221 usually needs to be connected to the inner skirt, such as by stitching. After designing the lower end of the leaflet body 221 with the above structure, the leaflet mechanism 200 is used in artificial heart valves and has better performance, which can effectively avoid regurgitation.

[0067] In some embodiments, referring to FIG1(d), when the lower end of the leaflet body 221 is connected to the inner skirt 400 as a leaflet fixing part, in order to avoid damage to the leaflet, a reinforcing strip 225 is provided on the leaflet fixing part, and the leaflet body 221 is connected to the inner skirt 400 together through the leaflet fixing part and the reinforcing strip 225.

[0068] In some embodiments, referring to FIG1(a), the leaflet bottom arc 2211 is an arc formed by a first radius R1, and the two leaflet side arcs 2212 are an arc formed by a second radius R2, then R2:R1=(2-5):1.

[0069] In some embodiments, referring to Figure 1(a), the arc length of the leaflet side arc 2212 is L2, and the arc length of the leaflet bottom arc 2211 is L1. Then L2:L1 = (1.2-2):1, such as 1.3:1, 1.5:1, 1.8:1, etc.

[0070] In some embodiments, referring to FIG1(a), the upper end profile of the leaflet body 221 has an upward protrusion, forming a protrusion 2213.

[0071] As shown in Figure 1(a), the free end of the leaflet body 221 protrudes upward as a free edge, forming a protrusion 2213. The design of the protrusion 2213 increases the contact area between the artificial leaflets 220 when the artificial heart valve is in the closed state, and the protrusion can fill the gap formed in the middle when the artificial leaflets 220 are closed, ensuring better fit between the artificial leaflets 220 and effectively avoiding regurgitation. This is because, especially for bulbar valve stents, due to their strong support, when the artificial leaflets 220 are in the closed state, their outflow ends still adhere to the aortic wall, or only move slightly radially towards the aortic central axis. The middle of the fit of multiple artificial leaflets 220 will form a triangular gap 229 as shown in Figure 1(e). The presence of the triangular gap 229 can cause regurgitation in the artificial heart valve. The design of the protrusion 2213 can increase the fit of the artificial leaflets 220 in the closed state and avoid regurgitation.

[0072] In some embodiments, referring to FIG1(a), two clearance cuts 226 are provided on the leaflet body 221, and the clearance cuts 226 are located at the connection between the leaflet body 221 and the first connecting portion 222.

[0073] As shown in Figure 1(a), the avoidance cut 226 has a triangular structure, which makes the leaf body 221 and the first connecting part 222 have an included angle.

[0074] Since the connector 210 needs to extend from the inside of the bracket 100 through the bracket connection hole 140 to the outside of the bracket 100, if there is no avoidance cut 226 during extension, the connection between the leaflet body 221 and the first connecting part 222 will wrinkle and may accumulate inside or on the side of the bracket connection hole 140, affecting the extension of the connector 210 and its connection with the fixing part 2231. Therefore, this embodiment designs an avoidance cut 226 at the connection between the leaflet body 221 and the first connecting part 222 to avoid the above-mentioned problem.

[0075] In some embodiments, referring to FIG1(a), the included angle α of the avoidance cut 226 is no greater than 90°, such as 85°, 80°, 75°, 70°, etc., which can ensure the fit between the leaflet body 221 and the inner side of the support 100, and also provide sufficient suturing space between the first connecting part 222 and the connector 210.

[0076] In some embodiments, the hole shape of the bracket 100, especially the bracket connection hole 140, has been improved. Referring to FIG2(c), the bracket connection hole 140 in this embodiment is a rectangular hole.

[0077] The bracket connection hole 140 is rectangular, which, compared to multiple circular holes, greatly increases the number of suture loops during connection, making it easier to sew multiple loops. This not only ensures more secure fixation of the leaflets but also avoids stress concentration, effectively extending the lifespan of the leaflets. Furthermore, the rectangular hole design provides sufficient space for the connector 210 to pass from the inside of the bracket 100 through the bracket connection hole 140 to the outside of the bracket 100.

[0078] In some embodiments, the rectangular hole is preferably an oblong hole, so that the inner walls of the upper and lower ends of the rectangular hole are arc-shaped surfaces to avoid wear on the connector 210.

[0079] In some embodiments, refer to Figures 2(a) to 2(d) The support 100 is in the shape of a hollow straight cylinder and includes an inflow section 110 and an outflow section 120 that are connected to each other.

[0080] The inflow section 110 includes multiple inflow section frame units 111 connected end to end and multiple inflow section connecting regions 112. The inflow section frame unit 111 is a hollow frame unit with inflow section mesh 113, and the inflow section connecting region 112 is the region where two adjacent inflow section frame units 111 are connected to each other.

[0081] The outflow section 120 includes multiple outflow section frame units 121 connected end to end and multiple outflow section connection areas 122. The outflow section frame unit 121 is a hollow frame unit with outflow section mesh 123. The outflow section connection area 122 is the area where two adjacent outflow section frame units 121 are connected to each other. Part of the outflow section connection area 122 is provided with a support connection hole 140 as a support connection part 122a.

[0082] Referring to Figure 2(a), when the leaflet mechanism 200 has three artificial leaflets 220, three of the outlet section connection areas 122 are provided with support connection holes 140 as support connection parts 122a, and the three support connection parts 122a are evenly arranged in the circumferential direction.

[0083] In some embodiments, two radially adjacent inflow section frame units 111 share a frame unit and a connection area, and two radially adjacent outflow section frame units 121 share a frame unit and a connection area.

[0084] In some embodiments, when the outflow end of the inflow section 110 is axially adjacent to the inflow end of the outflow section 120, that is, when the support 100 has only the inflow section 110 and the outflow section 120, the inflow section frame unit 111 and its axially adjacent outflow section frame unit 121 share adjacent frame units and connection areas.

[0085] In some embodiments, the inflow section mesh 113 is a gyroscope-shaped mesh.

[0086] The gyroscopic mesh design minimizes the contact area (axial constraint) between adjacent gyroscopic structures. After the valve expands following implantation, the reduced axial constraint allows for a larger expansion diameter. Located in the inflow segment of the valve, the gyroscopic structure provides greater contact area and friction with the aortic root, significantly improving the stent's impact resistance. Furthermore, the gyroscopic mesh design in the inflow segment allows for greater expansion after valve expansion, enabling the inflow stent to retract more towards the aorta, preventing the inflow segment from contacting the His bundle and thus avoiding atrioventricular block. This also reduces the axial dimension of the expanded valve, minimizing the impact on the patient.

[0087] In some embodiments, the outflow section mesh 123 is a hexagonal mesh.

[0088] In some embodiments, referring to FIG2(b), the outflow section frame unit 121 includes an upper outflow section protrusion 1211 and a lower outflow section protrusion 1212. The upper outflow section protrusion 1211 protrudes toward the outflow end along the axial direction of the support 100, and the lower outflow section protrudes away from the outflow end along the axial direction of the support 100.

[0089] The outflow section frame unit 121 also includes an upper support rod 1213 and a lower support rod 1214. The upper support rod 1213 is connected between the upper protrusion 1211 of the outflow section and the connecting area 122 of the outflow section, and the lower support rod 1214 is connected between the lower protrusion 1212 of the outflow section and the connecting area 122 of the outflow section.

[0090] Referring to Figure 2(c), when the outflow section connection area 122 is the support connection part 122a, the upper support rods 1213 of two adjacent outflow sections are connected side by side to the middle of the outflow end of the support connection part 122a, and the lower support rods 1214 of two adjacent outflow sections are connected side by side to the middle of the inflow end of the support connection part 122a.

[0091] In this embodiment, the outflow section frame unit 121 consists of an outflow section upper protrusion 1211, an outflow section upper support rod 1213, an outflow section connecting region 122, an outflow section lower support rod 1214, an outflow section lower protrusion 1212, another outflow section lower support rod 1214, another outflow section connecting region 122, and another outflow section upper support rod 1213, forming a hollow frame unit with an inflow section mesh 113. Two radially adjacent outflow section frame units 121 share the outflow section upper support rod 1213, the outflow section connecting region 122, and the outflow section lower support rod 1214.

[0092] After the stent connection hole 140 is designed as a rectangular hole, the axial frame rods on both sides of the rectangular hole on the stent connection portion 122a become narrower. During valve expansion, the axial frame rods of the rectangular hole are prone to become stress concentration points and indent inward, thereby squeezing the artificial leaflet 220 passing through the rectangular hole. To avoid this situation, in this embodiment, when the support rods at the upper and lower ends of the rectangular hole are connected, they are arranged side by side and connected at the middle of the upper and lower ends of the rectangular hole. During valve expansion, the rectangular hole as a whole acts as a stress support point to protect the rectangular hole and prevent the axial rods of the rectangular hole from indenting inward and squeezing the leaflet passing through the rectangular hole. In some embodiments, referring to FIG2(c), the width of the axial connecting rod 122a1 of the stent connection portion 122a is smaller than the width of the other outflow section connection areas 122. The rectangular structure of the stent connector 122a is equivalent to the combined action of two axial connecting rods 122a1 to provide support. Reducing the width of the axial connecting rods 122a1 in the stent connector 122a can minimize the contraction diameter of the valve under contraction conditions. On the other hand, it can maintain approximately equal support strength between the stent connector 122a and the other outflow segment connection area 122.

[0093] In some embodiments, referring to FIG2(b), the inflow section frame unit 111 includes an upper inflow section protrusion 1111 and a lower inflow section protrusion 1112. The upper inflow section protrudes in the direction of the outflow end along the axial direction of the support 100, and the lower inflow section protrudes in the direction away from the outflow end along the axial direction of the support 100.

[0094] The inflow section frame unit 111 also includes an upper support rod 1113 and a lower support rod 1114. The upper support rod 1113 is connected between the upper protrusion 1111 of the inflow section and the connecting area 112 of the inflow section, and the lower support rod 1114 is connected between the lower protrusion 1112 of the inflow section and the connecting area 112 of the inflow section.

[0095] In this embodiment, the inflow section frame unit 111 consists of an upper inflow section protrusion 1111, an upper inflow section support rod 1113, an inflow section connecting region 112, a lower inflow section support rod 1114, a lower inflow section protrusion 1112, another lower inflow section support rod 1114, another inflow section connecting region 112, and another upper inflow section support rod 1113, forming a hollow frame unit with inflow section mesh 113. The upper inflow section support rod 1113, the inflow section connecting region 112, and the lower inflow section support rod 1114 are located between two radially adjacent inflow section frame units 111.

[0096] In some embodiments, when the outflow end of the inflow section 110 is axially adjacent to the inflow end of the outflow section 120, i.e., when the support 100 has only the inflow section 110 and the outflow section 120, the upper support rod 1113 of the inflow section of the inflow section frame unit 111 is shared with the lower support rod 1214 of the outflow section of the axially adjacent outflow section frame unit 121. The inflow section connection area 112 is shared with the lower protrusion 1212 of the outflow section of the axially adjacent outflow section frame unit 121.

[0097] In some embodiments, the top inner side of the upper protrusion 1111 of the inflow section, the top inner side of the lower protrusion 1112 of the inflow section, and / or the top outer side of the lower protrusion 1112 of the inflow section are arc-shaped or elliptical arc-shaped.

[0098] In some embodiments, the inner top of the upper protrusion 1211 of the outflow section, the outer top of the upper protrusion 1211 of the outflow section, and / or the inner top of the lower protrusion 1212 of the outflow section are arc-shaped or elliptical. When the artificial heart valve is in a contracted state, due to the presence of the arc-shaped or elliptical shape, the adjacent upper support rod 1113 or the adjacent lower support rod 1114 of the inflow section will not be tightly attached together. The upper support rod 1113 or the lower support rod 1114 forms a certain angle with the valve central axis, providing a lever arm for subsequent radial balloon expansion and avoiding the problem of the artificial heart valve being unable to expand or inflate during surgery.

[0099] In some embodiments, there is an arc connection between two adjacent upper support rods 1213 of the outflow section, between two adjacent lower support rods 1214 of the outflow section, between the upper support rod 1213 of the outflow section and the adjacent outflow end connection area, and / or between the lower support rod 1214 of the outflow section and the adjacent outflow end connection area.

[0100] The bracket 100 is improved with rounded corners at each connection and end point. This makes the bracket 100 less prone to damage during radial contraction or expansion, and the radial diameter after contraction is smaller.

[0101] In some embodiments, refer to Figures 2(a) to 2(d)The support 100 also includes at least one transition section 130 disposed between the inflow section 110 and the outflow section 120. The transition section 130 includes a plurality of interconnected transition section frame units 131 and a plurality of transition section connection areas 132. The transition section frame unit 131 is a hollow frame unit with transition section mesh 133, and the transition section connection area 132 is the area where two adjacent transition section frame units 131 are interconnected.

[0102] In some embodiments, two radially adjacent transition segment frame units 131 share a frame unit and a connection area.

[0103] In some embodiments, the transition section frame unit 131 shares adjacent frame units and connection areas with its axially adjacent outflow section frame unit 121. The transition section frame unit 131 also shares adjacent frame units and connection areas with its axially adjacent inflow section frame unit 111.

[0104] In some embodiments, the axial length of the inflow section mesh 113 and the axial length of the outflow section mesh 123 are greater than the axial length of the transition section mesh 133. This design, with a larger axial length in the inflow section, firstly increases the contact area between the inflow section mesh 113 and the aortic root. Secondly, during the expansion of the artificial heart valve, the mesh size after expansion can be conformally selected according to the structure of the patient's aortic root, resulting in greater universality. Furthermore, for patients with more flexible aortic roots, this inflow end mesh structure can allow for greater retraction. Thirdly, the increased axial length of the inflow end mesh 113 also results in a larger coverage area of ​​the outer skirt, providing a larger sealing skirt and better prevention of paravalvular leakage.

[0105] In addition, the artificial heart valve is in a contracted state during delivery. When it is delivered to the aortic valve, a high-pressure balloon is needed to inflate the stent. During the inflation process, the transition segment mesh 133 has a greater resistance to opening. Therefore, compared with the outflow segment mesh 123 of the outflow segment and the inflow segment mesh 113 of the inflow segment, the transition segment mesh 133 expands more slowly. That is, the expansion process presents a "bone-like" shape that is thick at both ends and thin in the middle. This expansion method can ensure that the artificial heart valve is relatively fixed in position before and after expansion, and there will be no axial displacement during the expansion process, which ensures the accuracy of valve release position.

[0106] In some embodiments, referring to FIG2(b), the transition section frame unit 131 includes an upper transition section protrusion 1311 and a lower transition section protrusion 1312. The upper transition section protrusion 1311 protrudes in the direction of the outflow end along the axial direction of the support 100, and the lower transition section protrudes in the direction away from the outflow end along the axial direction of the support 100.

[0107] The transition section frame unit 131 also includes an upper support rod 1313 and a lower support rod 1314. The upper support rod 1313 is connected between the upper protrusion 1311 and the transition section connection area 132, and the lower support rod 1314 is connected between the lower support rod 1314 and the transition section connection area 132.

[0108] In this embodiment, the transition segment frame unit 131 consists of a transition segment upper protrusion 1311, a transition segment upper support rod 1313, a transition segment connecting area 132, a transition segment lower support rod 1314, a transition segment lower protrusion 1312, another transition segment lower support rod 1314, another transition segment connecting area 132, and another transition segment upper support rod 1313, forming a hollow frame unit with transition segment mesh 133. Two radially adjacent transition segment frame units 131 share the transition segment upper support rod 1313, the transition segment connecting area 132, and the transition segment lower support rod 1314.

[0109] In some embodiments, the transition section mesh 133 is a gyroscope-shaped mesh.

[0110] In some embodiments, when a transition section 130 is provided between the inflow section 110 and the outflow section 120, the upper support rod 1313 of the transition section frame unit 131 is shared with the lower support rod 1214 of the outflow section of the axially adjacent outflow section frame unit 121. The lower support rod 1314 of the transition section frame unit 131 is shared with the upper support rod 1113 of the inflow section of the axially adjacent inflow section frame unit 111. The transition section connecting region 132 is shared with the lower protrusion 1212 of the outflow section of the axially adjacent outflow section frame unit 121 and the upper protrusion 1111 of the inflow section of the axially adjacent inflow section frame unit 111.

[0111] In some embodiments, referring to FIG2(b), two transition sections 130 are provided between the inflow section 110 and the outflow section 120, and the two axially adjacent transition sections 130 share a transition section frame unit 131 and a transition section connection area 132.

[0112] The transition section 130 on the outflow end side shares the upper support rod 1313 of the transition section frame unit 131 with the lower support rod 1214 of the outflow section of the axially adjacent outflow section frame unit 121. The transition section connection area 132 shares the lower protrusion 1212 of the outflow section of the axially adjacent outflow section frame unit 121.

[0113] The transition section 130 on the inflow end side shares the lower support rod 1314 of the transition section frame unit 131 with the upper support rod 1113 of the inflow section of the axially adjacent inflow section frame unit 111. The transition section connection area 132 shares the upper protrusion 1111 of the inflow section of the axially adjacent inflow section frame unit 111.

[0114] When two transition sections 130 are provided, the support 100 is shown in Figure 2(b). The support 100 has four layers of mesh from the inflow end to the outflow end, namely one inflow section mesh 113, two transition section meshes 133, and one outflow section mesh 123. Optionally, the aperture of the two middle transition section meshes 133 is smaller than that of the upper and lower meshes.

[0115] In some embodiments, refer to Figures 3(a) to 4(b) The artificial heart valve in this embodiment also includes an outer skirt 300 and an inner skirt 400.

[0116] The outer skirt 300 is located outside the bracket 100, and the upper end of the outer skirt 300 is connected to the support rod 1113 on the inflow section of the inflow section frame unit 111. For example, as shown in Figure 2(b), it is on the second layer of support rods counting from the bottom.

[0117] The inner skirt 400 is located inside the stent 100. The upper end of the inner skirt 400 is connected to the lower support rod 1214 of the outflow section of the outflow section frame unit 121, for example, on the fourth support rod from the bottom up as shown in Figure 2(b). The inner skirt 400 wraps around the inner side of the stent 100 to the outer edge of the upper end face 1214a of the fourth support rod, as shown in Figures 2(a) and 2(e). With this design, after the artificial heart valve expands, the upper edge of the inner skirt contacts the aortic wall, which can achieve faster endothelialization and improve the fixation speed of the artificial heart valve.

[0118] The lower end of the inner skirt 400 is connected to the lower end of the outer skirt 300, and the inner skirt 400 and the outer skirt 300 form an annular cavity in the circumferential direction, which encloses the inflow section of the support 100.

[0119] When the stent 100 has a transition section 130, the outer periphery of the transition section 130 is not covered with a membrane. This design serves two purposes: First, after the artificial heart valve is implanted, endothelialization begins from the lower support rod 1214 and outer skirt 300 of the outflow section. Since the transition section 130 and its surrounding areas are not covered by the inner and outer skirts, any small amount of blood entering this area will form a thrombus due to the reduced flow velocity, resulting in a better sealing effect. Second, not covering the transition section 130 with a membrane reduces the diameter of the transition section in the closed state, facilitating delivery.

[0120] In some embodiments, the outer skirt 300 wraps from the inflow end of the bracket 100 to the upper end face 1113a of the upper support rod 1113 at the upper edge, such as... Figure 5 As shown. The inner side of the support rod 1113 on the inflow section is not wrapped by the outer skirt 300, which can minimize the diameter of the bracket 100 in the folded state.

[0121] In some embodiments, the upper edge of the inner skirt 400 wraps around the upper side of the lower support rod 1214 of the outflow section. The outer side of the lower support rod 1214 of the outflow section is not wrapped by the inner skirt 400, which can minimize the diameter of the bracket 100 in the folded state.

[0122] In some embodiments, referring to Figures 3(a) and 3(b), the upper end of the outer skirt 300 is integrally provided with a plurality of skirt protrusions 310, and a skirt U-shaped groove 320 is provided between two adjacent skirt protrusions 310.

[0123] Referring to Figures 4(a) and 4(b), the upper end of the inner skirt 400 is integrally provided with a plurality of skirt protrusions 410, and a skirt U-shaped groove 420 is provided between two adjacent skirt protrusions 410.

[0124] In this embodiment, both the outer skirt 300 and the inner skirt 400 are provided with skirt U-shaped grooves to ensure that no wrinkles occur after the inner and outer skirts wrap around the support rod.

[0125] In some embodiments, the skirt protrusion is a trapezoidal protrusion that is narrower at the top and wider at the bottom. This is to better cover the upper surface of the support rod without causing wrinkles after covering.

[0126] In some embodiments, referring to FIG3(b), taking the outer skirt 300 as an example, the distance between two adjacent skirt U-shaped grooves 320 is L3, and the width of the skirt U-shaped groove 320 is L4, then L3:L4 = (50-100):1, preferably (60-90):1.

[0127] The inner skirt 400 has the same structure as described above.

[0128] In some embodiments, referring to FIG3(b), the outer skirt 300 is provided with a plurality of skirt cuts 330, and the skirt cuts 330 are evenly distributed below the skirt U-shaped grooves 320 at intervals. When the outer skirt 300 is provided on the outside of the bracket 100, the skirt cuts 330 are located below the inflow section connection area 112.

[0129] The skirt incision 330 is a long and narrow incision. This design allows a small amount of blood to enter the annular cavity formed by the inner and outer skirts. Because the annular cavity is a relatively static environment, blood is more prone to thrombosis within it. This fills any gaps where the outer skirt 300 does not seal tightly against the aortic wall, further improving the seal of the artificial heart valve. Until the outer skirt 300 becomes endothelialized, the long and narrow incision is covered by the proliferating tissue, and the artificial heart valve is stably fixed at the aortic root, better preventing paravalvular leakage. Using a long and narrow incision instead of a groove allows blood to enter and exit the annular cavity while avoiding the danger of thrombus leakage. Furthermore, since the artificial heart valve is soaked in glutaraldehyde solution before use, a certain amount of glutaraldehyde solution accumulates in the annular cavity. The long and narrow incision ensures that the glutaraldehyde is completely drained during the cleaning process before pressing and squeezing the artificial heart valve.

[0130] In some embodiments, referring to FIG3(b), a skirt U-shaped groove 320 is provided between two adjacent skirt cutouts 330.

[0131] In some embodiments, the skirt cutout 330 is located directly below the corresponding skirt U-shaped groove 320.

[0132] In some embodiments, the upper end of the skirt hem cut 330 is connected to the skirt hem U-shaped groove 320. After suturing, this area is more likely to bulge outwards. By placing the skirt hem cut 330 here, the skirt hem cut 330 is less likely to be covered, making it easier for blood to enter the annular cavity from the skirt hem cut 330.

[0133] In some embodiments, referring to FIG3(c), a plurality of sewing grooves 340 are provided at the lower end of the outer skirt 300. A plurality of sewing grooves 340 are uniformly provided at the lower end of the inner skirt 400. When sewing the inner and outer skirts, the sewing grooves 340 can serve as positioning elements to relatively determine the positions of the inner and outer skirts, thereby improving the efficiency of the sewing operation of the inner and outer skirts.

[0134] In some embodiments, referring to Figure 3(a), the perimeter of the outer skirt 300 is L5, and referring to Figure 4(a), the perimeter of the inner skirt 400 is L6, then L5:L6 = (1.1-1.3):1.

[0135] The outer skirt 300 has a circumference greater than that of the inner skirt 400, which allows the inner skirt 400 to fit tightly against the inner side of the support 100, thus relatively restricting the movement space of the inner skirt 400. This provides a stable environment for the leaflet, allowing the artificial leaflet to reduce external interference in the closed state and form a closed surface according to the designed closed curvature, thereby reducing the occurrence of backflow.

[0136] In some embodiments, both the outer skirt 300 and the inner skirt 400 are made of woven structural material.

[0137] In some embodiments, referring to FIG4(b), the weave texture of the inner skirt 400 is consistent with the length direction of the upper support rod 1113 of the inflow section and the length direction of the lower support rod 1114 of the inflow section.

[0138] During the retraction process, the support 100 will stretch along the axial direction of the support 100. The texture of the inner skirt 400 is arranged in the same direction as the two support rods of the inflow section frame unit 111, so that the inner skirt 400 has greater extensibility during the axial stretching of the support 100, reducing the constraint on the axial direction of the support.

[0139] Since the outer skirt 300 has sufficient axial dimensions, it does not restrict the axial extension of the support, so there are no requirements for the weaving direction. In order to facilitate sewing and increase the strength of the outer skirt 300, the weaving direction can be selected to extend in the axial and / or radial directions.

[0140] In some embodiments, after the inner skirt 400 is sewn into a cylindrical shape at both ends, it is sewn to the inside of the bracket 100, and the lower end of the leaflet body 221 is sewn onto the inner skirt 400 as a leaflet fixing part.

[0141] This application mainly uses the balloon-expandable valve stent as an example for illustration. However, the shapes of the artificial valve leaflets and stents disclosed in this application are not limited to the use of balloon-expandable artificial heart valves. Self-expanding artificial heart valves made of nickel-titanium alloy are also applicable.

[0142] The present invention has been described in detail above with reference to the accompanying drawings and embodiments. Those skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention, and the scope of protection of the present invention shall be defined by the appended claims.

Claims

1. An artificial implant scaffold, wherein the artificial implant scaffold is provided with a plurality of scaffold connection holes for connecting with a leaflet mechanism; Its features are, The bracket connection hole is a rectangular hole; The artificial implant scaffold includes: An outflow section includes multiple outflow section frame units connected end to end and multiple outflow section connection areas. The outflow section frame unit is a hollow frame unit with outflow section mesh. The outflow section connection area is the area where two adjacent outflow section frame units are connected to each other. Several outflow section connection areas are provided with support connection holes as support connection parts.

2. The artificial implant scaffold as described in claim 1, characterized in that, The width of the axial connecting rod of the bracket connection part with the bracket connection hole is smaller than the width of the other outflow section connection areas.

3. The artificial implant scaffold as described in claim 1, characterized in that, The outflow section frame unit includes an upper outflow section protrusion and a lower outflow section protrusion. The upper outflow section protrudes towards the outflow end along the axial direction of the artificial implant stent, and the lower outflow section protrudes away from the outflow end along the axial direction of the artificial implant stent. The outflow section frame unit further includes an upper support rod and a lower support rod for the outflow section. The upper support rod for the outflow section is connected between the upper protrusion of the outflow section and the connecting area of ​​the outflow section, and the lower support rod for the outflow section is connected between the lower protrusion of the outflow section and the connecting area of ​​the outflow section. When the outflow section connection area is the bracket connection part, the upper support rods of two adjacent outflow sections are connected side by side to the middle of the outflow end of the bracket connection part, and the lower support rods of two adjacent outflow sections are connected side by side to the middle of the inflow end of the bracket connection part.

4. The artificial implant scaffold as described in claim 1, 2, or 3, characterized in that, The artificial implant scaffold also includes: An inflow section is located at the inflow end of the outflow section. The inflow section includes multiple inflow section frame units connected end to end and multiple inflow section connecting areas. The inflow section frame unit is a hollow frame unit with inflow section mesh. The inflow section connecting area is the area where two adjacent inflow section frame units are connected to each other.

5. The artificial implant scaffold as described in claim 4, characterized in that, The inflow section mesh is a gyroscope-shaped mesh; And / or, the outflow section mesh is a hexagonal mesh.

6. The artificial implant scaffold as described in claim 4, characterized in that, The inflow section frame unit includes an upper inflow section protrusion and a lower inflow section protrusion. The upper inflow section protrudes towards the outflow end along the axial direction of the artificial implant stent, and the lower inflow section protrudes away from the outflow end along the axial direction of the artificial implant stent. The inflow section frame unit further includes an upper support rod and a lower support rod. The upper support rod is connected between the upper protrusion of the inflow section and the connecting area of ​​the inflow section, and the lower support rod is connected between the lower protrusion of the inflow section and the connecting area of ​​the inflow section.

7. The artificial implant scaffold as described in claim 4, characterized in that, The artificial implant scaffold also includes: At least one transition section is provided between the inflow section and the outflow section. The transition section includes multiple transition section frame units connected end to end and multiple transition section connection areas. The transition section frame unit is a hollow frame unit with transition section mesh. The transition section connection area is the area where two adjacent transition section frame units are connected to each other.

8. The artificial implant scaffold as described in claim 7, characterized in that, The radial length of the transition section mesh is less than the radial length of the inflow section mesh and the radial length of the outflow section mesh. And / or, the axial length of the transition section mesh is less than the axial length of the inflow section mesh and the axial length of the outflow section mesh.

9. The artificial implant scaffold as described in claim 7, characterized in that, The transition section frame unit includes an upper transition section protrusion and a lower transition section protrusion. The upper transition section protrudes towards the outflow end along the axial direction of the artificial implant stent, and the lower transition section protrudes away from the outflow end along the axial direction of the artificial implant stent. The transition section frame unit further includes an upper support rod and a lower support rod. The upper support rod connects the upper protrusion of the transition section and the connection area of ​​the transition section, and the lower support rod connects the lower support rod of the transition section and the connection area of ​​the transition section.

10. The artificial implant scaffold as described in claim 7, characterized in that, The transition section has a gyroscope-shaped mesh.

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