A prosthetic valve device

Abstract

The present application relates to the technical field of medical devices, and discloses an artificial valve device. The artificial valve device comprises a support, the support has a blood flow inflow end and a blood flow outflow end, and the blood flow inflow end and the blood flow outflow end are oppositely arranged along a preset direction. The support comprises a plurality of mesh structure layers which are distributed layer by layer along the preset direction. The mesh structure layer at the blood flow outflow end is a target mesh structure layer, and the connecting part of the target mesh structure layer protrudes towards the blood flow inflow end; and / or the mesh structure layer at the blood flow inflow end is a target mesh structure layer, and the connecting part of the target mesh structure layer protrudes towards the blood flow outflow end. The artificial valve device further comprises a valve, and the valve is connected to the support. In the above manner, the axial positioning performance of the artificial valve device can be improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an artificial valve device. Background Technology

[0002] The aortic valve is a tricuspid valve located between the left ventricular outflow tract and the ascending aorta. Its primary function is to maintain effective left ventricular ejection. The valve is affected under many pathological conditions, resulting in a variety of abnormalities. Aortic valve disease is a common condition in the clinical practice of cardiologists and cardiac surgeons, mainly due to its higher incidence in the elderly. Treatment methods for severe aortic valve disease include surgical repair or replacement of the valve. Standard surgical treatment strategies include aortic valve repair, valve preservation techniques, and aortic valve replacement.

[0003] Aortic valve diseases include aortic stenosis and aortic regurgitation, and in most cases, both coexist. Aortic stenosis accounts for the majority of aortic valve diseases, with an incidence of 1-2% in people over 65 years of age and 4% in people over 85 years of age.

[0004] The technical principle of transcatheter aortic valve replacement (TAVR) is to compress and load a fixed stent with an artificial valve into a delivery system, then deliver it along an inlet (such as an artery) to the aortic valve and release it, squeezing the diseased aortic valve next to the artificial valve, while the artificial aortic valve is fixed at the aortic valve, replacing the diseased aortic valve.

[0005] However, current artificial valve stents have poor axial positioning performance during expansion, which cannot guarantee that the artificial valve stent is accurately anchored at the lesion site. Summary of the Invention

[0006] In view of this, the main technical problem solved by the present invention is to provide an artificial valve device that can improve the axial positioning performance of the artificial valve device.

[0007] To solve the above-mentioned technical problems, one technical solution adopted by the present invention is to provide an artificial valve device. The artificial valve device includes a stent having a blood inflow end and a blood outflow end, which are arranged opposite to each other along a predetermined direction. The stent includes a plurality of mesh structure layers distributed layer by layer along the predetermined direction. Each mesh structure layer includes a connecting portion and at least two support rod portions, which are sequentially spaced along a predetermined circumferential direction, and a connecting portion is provided between any two adjacent support rod portions. The predetermined direction is perpendicular to the plane defined by the predetermined circumferential direction. The mesh structure layer at the blood outflow end is the target mesh structure layer, and the connecting portion of the target mesh structure layer protrudes towards the blood inflow end; and / or the mesh structure layer at the blood inflow end is the target mesh structure layer, and the connecting portion of the target mesh structure layer protrudes towards the blood outflow end. The artificial valve device also includes a valve connected to the stent.

[0008] In one embodiment of the present invention, the connecting portion includes a first connecting rod portion and a second connecting rod portion. The first connecting rod portion is connected to the second connecting rod portion, and the first connecting rod portion is also connected to a support rod portion on one side of the connecting portion, and the second connecting rod portion is also connected to a support rod portion on the other side of the connecting portion. In the target mesh structure layer, the length of the first connecting rod portion and the length of the second connecting rod portion are both less than the length of the support rod portion.

[0009] In one embodiment of the present invention, the support rod is provided with a fixing part, and the valve is connected to the bracket through the fixing part.

[0010] In one embodiment of the present invention, the support rod portion of the target mesh structure layer includes a main support rod; the main support rod includes a rod body portion and a fixing portion, the fixing portion being closer to the blood flow inlet end relative to the rod body portion; the connecting portion includes a main connecting portion, the first connecting rod portion of the main connecting portion being connected to the rod body portion, wherein the length of the first connecting rod portion of the main connecting portion is less than the length of the rod body portion.

[0011] In one embodiment of the present invention, the first connecting rod portion and the second connecting rod portion are connected to the first connecting end; the support rod portion of the target mesh structure layer further includes an auxiliary support rod, and the connecting portion further includes an auxiliary connecting portion, which is disposed between adjacent auxiliary support rods; wherein, the first connecting end of the auxiliary connecting portion is closer to the blood flow inlet end relative to the first connecting end of the main connecting portion.

[0012] In one embodiment of the present invention, the mesh structure layer at the blood outflow end is the target mesh structure layer; the length of the support rod portion of the target mesh structure layer is greater than the length of the support rod portion of other mesh structure layers in the stent.

[0013] In one embodiment of the present invention, the first connecting rod portion and the second connecting rod portion connected in each mesh structure layer form an included angle, which is 95° to 120°.

[0014] In one embodiment of the present invention, the mesh structure layer located at the blood outflow end is the target mesh structure layer; the included angle formed by the first connecting rod portion and the second connecting rod portion connected in the target mesh structure layer is smaller than the included angle formed by the first connecting rod portion and the second connecting rod portion connected in other mesh structure layers.

[0015] In one embodiment of the present invention, at least two connecting portions are provided between at least two adjacent support rod portions in the target mesh structure layer.

[0016] In one embodiment of the present invention, the connecting part and the support rod part are connected to the second connecting end; wherein the length of the second connecting end in the preset circumferential direction is 1mm to 1.5mm.

[0017] The beneficial effects of this invention are as follows: Unlike existing technologies, this invention provides an artificial valve device. This artificial valve device includes a stent comprising a plurality of mesh structure layers distributed layer by layer along a predetermined direction. The mesh structure layer at the blood outflow end is the target mesh structure layer, and the connecting portion of the target mesh structure layer protrudes towards the blood inflow end; and / or the mesh structure layer at the blood inflow end is the target mesh structure layer, and the connecting portion of the target mesh structure layer protrudes towards the blood outflow end. In this way, when the stent expands, the connecting portion of the target mesh structure layer does not cause a change in the length of the stent in the predetermined direction. That is, this invention can reduce the change in the axial (i.e., predetermined direction) length of the stent during expansion, which helps to ensure that the artificial valve device of this invention has good axial positioning performance and can ensure that the artificial valve device is accurately anchored at the lesion site. Therefore, this invention can improve the axial positioning performance of the artificial valve device. Attached Figure Description

[0018] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention. Furthermore, these drawings and textual descriptions are not intended to limit the scope of the inventive concept in any way, but rather to illustrate the concept of the invention to those skilled in the art by reference to specific embodiments.

[0019] Figure 1 This is a schematic diagram of the structure of an embodiment of the artificial valve device of the present invention;

[0020] Figure 2 yes Figure 1 A top view of the artificial valve device shown.

[0021] Figures 3a-3b This is a schematic diagram of the structure of the first embodiment of the bracket of the present invention;

[0022] Figure 4 yes Figure 3a A schematic diagram of the unfolded structure of the bracket shown;

[0023] Figure 5 yes Figure 4 A partial structural diagram of region D of the support shown;

[0024] Figure 6 This is a schematic diagram of the unfolded structure of the second embodiment of the bracket of the present invention;

[0025] Figure 7 This is a schematic diagram of the unfolded structure of the third embodiment of the bracket of the present invention;

[0026] Figure 8 This is a schematic diagram of the unfolded structure of the fourth embodiment of the bracket of the present invention;

[0027] Figure 9 This is a schematic diagram of the unfolded structure of the fifth embodiment of the bracket of the present invention. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions in the embodiments of this invention will be clearly and completely described below in conjunction with the embodiments of this invention. Obviously, the described embodiments are only some embodiments of this invention, not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0029] To address the technical problem of poor axial positioning performance during expansion in existing artificial valve stents, an embodiment of the present invention provides an artificial valve device. This artificial valve device includes a stent with a blood inflow end and a blood outflow end, which are arranged opposite each other along a predetermined direction. The stent includes a plurality of mesh structure layers distributed layer by layer along the predetermined direction. Each mesh structure layer includes a connecting portion and at least two support rod portions, which are sequentially spaced along a predetermined circumferential direction, with a connecting portion between any two adjacent support rod portions. The predetermined direction is perpendicular to the plane defined by the predetermined circumferential direction. The mesh structure layer at the blood outflow end is a target mesh structure layer, and the connecting portion of the target mesh structure layer protrudes towards the blood inflow end; and / or the mesh structure layer at the blood inflow end is a target mesh structure layer, and the connecting portion of the target mesh structure layer protrudes towards the blood outflow end. The artificial valve device also includes a valve connected to the stent. The following provides a detailed description.

[0030] Please see Figure 1 and Figure 2 , Figure 1 This is a schematic diagram of the structure of an embodiment of the artificial valve device of the present invention. Figure 2 yes Figure 1 The diagram shows a top view of the artificial valve device.

[0031] In one embodiment, the artificial valve device can be applied to procedures such as transcatheter aortic valve replacement. Specifically, the artificial valve device can be compressed and loaded into a delivery system, then delivered along the access route to the aortic valve and released at the aortic valve, causing the artificial valve device to expand to squeeze the diseased aortic valve next to the artificial valve device, thereby anchoring the artificial valve device at the aortic valve and replacing the diseased aortic valve.

[0032] Specifically, the artificial valve device includes a stent 10 and a valve 20. The stent 10 is used to anchor the valve 20 at the lesion site. To accommodate transcatheter aortic valve replacement, the stent 10 in this embodiment is compressible and expandable; that is, the stent 10 can be compressed for loading into the delivery system and can be expanded at the lesion site to anchor it there. The valve 20 connects to the stent 10 and can be anchored at the lesion site along with the stent 10 to replace the diseased aortic valve.

[0033] Furthermore, the valve 20 can be connected to the stent 10 by means of suturing, welding, etc., and the suturing method will be described in detail below.

[0034] In one embodiment, the stent 10 has a blood inflow end A and a blood outflow end B, and the blood inflow end A and the blood outflow end B are aligned in a predetermined direction (e.g., Figure 1 (As indicated by the middle arrow X, the same below) are arranged opposite each other. The support 10 includes several mesh structure layers distributed layer by layer along a preset direction. The mesh structure layer includes a connecting part 11 and at least two support rod parts 12. The at least two support rod parts 12 are arranged along a preset circumferential direction (e.g., ...). Figure 1 As indicated by the middle arrow O (the same applies below), the support rods are arranged at intervals, and a connecting part 11 is provided between any two adjacent support rods 12. The preset direction is perpendicular to the plane defined by the preset circumferential direction.

[0035] In one embodiment, the mesh structure layer located at the blood outflow end B is the target mesh structure layer. The connecting portion 11 of the target mesh structure layer protrudes towards the blood inflow end A. Furthermore, this connecting portion 11 is located at the blood inflow end A.

[0036] In the above manner, when the stent 10 expands, the connecting portion 11 of the target mesh structure layer will not cause a change in the length of the stent 10 in the preset direction. That is, this embodiment can reduce the amount of change in the axial (i.e., preset direction) length of the stent 10 during the expansion process, which is beneficial to ensure that the artificial valve device of this embodiment has good axial positioning performance, can ensure that the stent 10 is accurately anchored to the lesion site, and reduce the risk of the stent 10 deviating from the lesion site. Therefore, this embodiment can improve the axial positioning performance of the artificial valve device.

[0037] Please refer to the following: Figures 3a to 5 , Figures 3a-3b This is a structural schematic diagram of the first embodiment of the bracket of the present invention. Figure 4 yes Figure 3a The diagram shows the unfolded structure of the support frame. Figure 5 yes Figure 4 A partial structural diagram of region D of the support shown. Wherein, Figure 3b The bracket of the present invention is shown in a compressed state.

[0038] Furthermore, the connecting portion 11 includes a first connecting rod portion 111 and a second connecting rod portion 112. The first connecting rod portion 111 is connected to the second connecting rod portion 112, and the first connecting rod portion 111 is also connected to a support rod portion 12 on one side of the connecting portion 11, while the second connecting rod portion 112 is also connected to a support rod portion 12 on the other side of the connecting portion 11.

[0039] In the target mesh structure layer, the lengths of the first connecting rod portion 111 and the second connecting rod portion 112 are both less than the length of the supporting rod portion 12. Therefore, after compressing the support 10, the first connecting rod portion 111 and the second connecting rod portion 112 of the target mesh structure layer will not interfere with other mesh structure layers of the support 10, reducing the risk of wear caused by structural interference and helping to ensure the overall reliability of the support 10. Figure 3b As shown.

[0040] It should be noted that the central axis of the support rod 12 is parallel to the aforementioned preset direction, and the length of the support rod 12 should be understood as the length of the support rod 12 in that preset direction.

[0041] Furthermore, the aforementioned at least two support rod portions 12 include a main support rod 121, which includes a rod body portion 1211 and a fixing portion 1212. The valve 20 is connected to the stent 10 through the fixing portion 1212. The fixing portion 1212 is connected to the rod body portion 1211, and the fixing portion 1212 is closer to the blood flow inlet end A relative to the rod body portion 1211.

[0042] Furthermore, the fixing part 1212 has a fixing hole through which the valve 20 is connected to the support 10. The fixing hole can be rectangular or circular, etc., and is not limited here.

[0043] The connecting portion 11 includes a main connecting portion 113. A first connecting rod portion 111 of the main connecting portion 113 connects to a rod body portion 1211. The length of the first connecting rod portion 111 of the main connecting portion 113 is less than the length of the rod body portion 1211. In this way, after compressing the bracket 10, the first connecting rod portion 111 of the main connecting portion 113 will not interfere with the fixing portion 1212, further reducing the risk of wear on the bracket 10 due to structural interference and helping to ensure the overall reliability of the bracket 10.

[0044] The remaining support rod portion 12 among the at least two support rod portions 12 mentioned above is an auxiliary support rod 122, and the main support rod 121 and the auxiliary support rod 122 are distributed at intervals along a predetermined circumferential direction. The first connecting rod portion 111 and the second connecting rod portion 112 are connected to the first connecting end 115. The connecting portion 11 also includes an auxiliary connecting portion 114, which is disposed between adjacent auxiliary support rods 122.

[0045] like Figure 5 As shown, the length of the rod body 1211 of the main support rod 121 is L1, where L1 can be 4mm to 7mm, such as 4mm, 5mm, 6mm, 7mm, etc. The length of the auxiliary support rod 122 in the preset direction is L2, where L2 can be 5mm to 8mm, such as 5mm, 6mm, 7mm, 8mm, etc. L2 > L1, and the length difference between the two is the length of the fixing part 1212 in the preset direction. The length of the first connecting rod 111 of the main connecting part 113 is less than the length of the rod body 1211 of the main support rod 121, so that the first connecting rod 111 of the main connecting part 113 will not interfere with the fixing part 1212. The length of the connecting rod of the auxiliary connecting part 114 is less than the length of the auxiliary support rod 122, so that the connecting rod of the auxiliary connecting part 114 will not interfere with other mesh structure layers of the bracket 10.

[0046] The first connecting end 115 of the auxiliary connecting part 114 is closer to the blood flow inlet end A than the first connecting end 115 of the main connecting part 113. Since the main support rod 121 has a fixing part 1212, while the auxiliary support rod 122 does not, to avoid interference with the fixing part 1212, the connecting rod portion of the main connecting part 113 is designed to have a shorter length, so that the first connecting end 115 of the auxiliary connecting part 114 is closer to the blood flow inlet end A than the first connecting end 115 of the main connecting part 113.

[0047] The auxiliary connecting part 114 has a relatively long connecting rod portion, which means that the included angle formed by the first connecting rod portion 111 and the second connecting rod portion 112 of the auxiliary connecting part 114 is small, i.e., the auxiliary connecting part 114 has relatively low strength. When the reticular structure layer at the blood outflow end B is the target reticular structure layer, the low strength of the auxiliary connecting part 114 makes it easier for the portion of the stent 10 at the blood outflow end B to expand.

[0048] The first connecting end 115 of the auxiliary connecting part 114 is closer to the blood flow inlet end A than the first connecting end 115 of the main connecting part 113, which makes the mesh of the main connecting part 113 larger, which is beneficial for percutaneous coronary intervention (PCI), such as facilitating the passage of instruments through the mesh of the main connecting part 113.

[0049] like Figure 5 As shown, the length of the connecting rod portion of the main connecting portion 113 (including the first connecting rod portion 111 and the second connecting rod portion 112 mentioned above) is less than the length of the connecting rod portion of the auxiliary connecting portion 114, such that the first connecting end 115 of the auxiliary connecting portion 114 is closer to the blood flow inlet end A relative to the first connecting end 115 of the main connecting portion 113. Furthermore, the distance between the first connecting end 115 of the auxiliary connecting portion 114 and the first connecting end 115 of the main connecting portion 113 in a predetermined direction is d, where d can be from 1mm to 3mm, for example, 1mm, 2mm, 3mm, etc.

[0050] Please continue reading. Figure 4 and Figure 5 In one embodiment, the connecting portion 11 and the support rod portion 12 are connected to the second connecting end 14, that is, the second connecting end 14 is located at the blood outflow end B. The length w of the second connecting end 14 in the predetermined circumferential direction can be from 1 mm to 1.5 mm, for example, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, etc. In this way, the second connecting end 14 has a larger size, which can reduce the pressure of the second connecting end 14 on the blood vessel and reduce the risk of the second connecting end 14 puncturing the blood vessel.

[0051] Please continue reading. Figure 4 In one exemplary embodiment, the support 10 adopts a double-layer mesh structure design, that is, the support 10 includes two mesh structure layers. Each mesh structure layer of the support 10 is a polygonal mesh structure, and the mesh openings of the polygonal mesh structure can be quadrilateral, hexagonal, etc.

[0052] Specifically, the stent 10 includes a first mesh structure layer 15 and a second mesh structure layer 16. The first mesh structure layer 15 and the second mesh structure layer 16 are distributed sequentially in the direction from the blood outflow end B to the blood inflow end A.

[0053] The first mesh structure layer 15 includes a first connecting portion 151 and a first support rod portion 152. The first support rod portions 152 are distributed sequentially at intervals along a preset circumferential direction, and a first connecting portion 151 is provided between any two adjacent first support rod portions 152. The second mesh structure layer 16 includes a second connecting portion 161 and a second support rod portion 162. The second support rod portions 162 are distributed sequentially at intervals along a preset circumferential direction, and a second connecting portion 161 is provided between any two adjacent second support rod portions 162. The second connecting portion 161 is also connected to the first support rod portion 152. A third connecting portion 171 is also provided between any two adjacent second support rod portions 162 on the stent 10. The third connecting portion 171 is closer to the blood flow inlet end A relative to the second connecting portion 161.

[0054] For example, in the case where the mesh structure layer at the blood outflow end B is the target mesh structure layer, the first mesh structure layer 15 in this embodiment is the target mesh structure layer. The first connecting portion 151 of the first mesh structure layer 15 is the connecting portion of the target mesh structure layer, and the first supporting rod portion 152 of the first mesh structure layer 15 is the supporting rod portion of the target mesh structure layer.

[0055] like Figure 1 and Figure 2 As shown, the valve 20 includes leaflets 21 and a skirt 22. The stent 10 is arranged along a predetermined circumferential direction to form a receiving area C. The leaflets 21 are disposed in the receiving area C and are used to replace the diseased original heart valve. The skirt 22 is disposed at the blood flow inlet A of the stent 10 and covers the inner and outer sides of the blood flow inlet A of the stent 10 to prevent paravalvular leakage. The leaflets 21 are connected to the stent 10, and the connection method includes suturing, welding, adhesive bonding, etc. In one embodiment, the leaflets 21 are sutured to the stent 10.

[0056] For example, in the case where the leaflets 21 are sewn to the support 10, there are three leaflets 21. Each leaflet 21 has a protrusion that matches the fixing hole. The protrusion of each leaflet 21 is inserted into the fixing hole, and each leaflet 21 is sequentially sewn to the support 10 using sutures. In this embodiment, the fixing part 1212 has at least two fixing holes, through which the leaflets 21 are sewn to the support 10, such as... Figure 5 As shown.

[0057] Furthermore, a pad can be added during the suturing process of the leaflet 21 and the fixing hole to increase the area of ​​the suture site, which is beneficial to the suturing operation. The skirt 22 and the support 10 can be joined by one or more methods such as suturing with suture thread or welding.

[0058] The support 10 can be made of a metallic material. Optionally, the support 10 can be made of at least one of stainless steel, cobalt-chromium alloy, etc. Preferably, the support 10 can be made of MP35N alloy, which contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. This reduces the amount of material used in the support 10, which helps to reduce the volume of the support 10 after compression, and also enables the support 10 to have good pressure resistance, fatigue resistance, and corrosion resistance.

[0059] The outer diameter of the expanded stent 10 (e.g.) Figure 2 As shown in D (hereinafter the same) and height (i.e., axial length, such as Figure 3aAs shown in H (the same below), there is a certain correlation, that is, when the outer diameter of the stent 10 after expansion is determined, the height of the stent 10 after expansion has a certain value corresponding to it, so that the stent 10 can be well anchored to the lesion site when it is actually used to replace the aortic valve, and the valve 20 on the stent 10 can work well.

[0060] Specifically, after the stent 10 is expanded externally (not inserted into the human body), its outer diameter can be from 12mm to 36mm, such as 12mm, 18mm, 20mm, 23mm, 26mm, 29mm, 32mm, 36mm, etc., preferably 18mm to 32mm; its height can be from 15mm to 28mm, such as 15mm, 15.5mm, 18mm, 20mm, 22.5mm, 25mm, 28mm, etc. The following examples illustrate some of the specifications of the outer diameter and height of the stent 10 after expansion.

[0061]

[0062] like Figure 2 As shown, the wall thickness W of the stent 10 can be from 0.2 mm to 0.6 mm, such as 0.2 mm, 0.3 mm, 0.46 mm, 0.5 mm, 0.55 mm, 0.6 mm, etc., preferably from 0.3 mm to 0.55 mm. This ensures that the stent 10 has sufficient anchoring force and sufficient strength, guaranteeing good pressure resistance and fatigue resistance. Simultaneously, it ensures sufficient internal space for a sufficiently large leaflet 21, which is beneficial for improving the success rate of aortic valve replacement. Furthermore, the wall thickness of the stent 10 at the blood inflow end and the stent 10 at the blood outflow end can be the same or have a certain difference.

[0063] Furthermore, the stent 10 can be integrally formed or welded from a metal tube using laser technology. For example, excess portions of a metal tube of the appropriate specifications can be removed by laser cutting, leaving the metal stent 10. After removing residues through processes such as grinding and acid pickling, it undergoes heat treatment to improve the mechanical properties of the stent 10 material. Of course, the stent 10 can also be electrochemically polished to achieve better surface finish and biocompatibility, which is beneficial for improving the success rate of aortic valve replacement.

[0064] Please see Figure 6 and Figure 7 , Figure 6 This is a schematic diagram of the unfolded structure of the second embodiment of the bracket of the present invention. Figure 7 This is a schematic diagram of the unfolded structure of the third embodiment of the bracket of the present invention.

[0065] In another exemplary embodiment, the support 10 may also adopt a three-layer mesh structure design, that is, the support 10 includes three mesh structure layers.

[0066] Specifically, the stent 10 includes a first mesh structure layer 15, a second mesh structure layer 16, and a third mesh structure layer 17. The first mesh structure layer 15, the second mesh structure layer 16, and the third mesh structure layer 17 are distributed sequentially from the blood outflow end B towards the blood inflow end A.

[0067] The first mesh structure layer 15 includes a first connecting portion 151 and a first support rod portion 152. The first support rod portions 152 are distributed sequentially at intervals along a preset circumferential direction, and a first connecting portion 151 is provided between any two adjacent first support rod portions 152. The second mesh structure layer 16 includes a second connecting portion 161 and a second support rod portion 162. The second support rod portions 162 are distributed sequentially at intervals along a preset circumferential direction, and a second connecting portion 161 is provided between any two adjacent second support rod portions 162, connecting the first support rod portion 152. The third mesh structure layer 17 includes a third connecting portion 171 and a third support rod portion 172. The third support rod portions 172 are distributed sequentially at intervals along a preset circumferential direction, and a third connecting portion 171 is provided between any two adjacent third support rod portions 172, connecting the second support rod portion 162.

[0068] Furthermore, a fourth connecting part 181 is provided between any two adjacent third support rod parts 172 on the stent 10, and the fourth connecting part 181 is closer to the blood flow inlet end A relative to the third connecting part 171.

[0069] Please continue reading. Figure 6 In one embodiment, the first support rod 152 primarily serves to support the valve 20 after the artificial valve device is anchored at the lesion site. The second support rod 162 primarily serves an anchoring function, that is, the second support rod 162 mainly provides the anchoring force to anchor the artificial valve device at the lesion site. The collapse action of the stent 10 specifically involves the second support rod 162 and the third support rod 172 moving towards the blood outflow end B during the expansion of the stent 10. The second support rod 162 and the third support rod 172 also cooperate to prevent paravalvular leakage.

[0070] The length S2 of the second support rod portion 162 in the preset direction is less than the length S3 of the third support rod portion 172 in the preset direction, while the dimensions of the second connecting portion 161 and the third connecting portion 171 are not significantly different. This means that the mesh area of ​​the second mesh structure layer 16 is smaller than the mesh area of ​​the third mesh structure layer 17. In other words, the second mesh structure layer 16 can provide a greater anchoring force to ensure that the artificial valve device is reliably anchored to the lesion site.

[0071] Optionally, the ratio of the length S2 of the second support rod 162 in the preset direction to the length S3 of the third support rod 172 in the preset direction is 1:2-3. Preferably, the ratio of the length S2 of the second support rod 162 in the preset direction to the length S3 of the third support rod 172 in the preset direction is 1:3. This ensures that the second support rod 162 can provide sufficient anchoring force, further ensuring that the artificial valve device is reliably anchored to the lesion site.

[0072] For example, such as Figure 6 As shown, the length S1 of the first support rod 152 in the preset direction can be 5mm to 7mm, such as 5mm, 6mm, 7mm, etc. The length S2 of the second support rod 162 in the preset direction can be 1mm to 2mm, such as 1mm, 1.5mm, 2mm, etc. The length S3 of the third support rod 172 in the preset direction can be 3mm to 4mm, such as 3mm, 3.5mm, 4mm, etc., but the ratio of the length S2 of the second support rod 162 in the preset direction to the length S3 of the third support rod 172 in the preset direction must be 1:3.

[0073] Please continue reading. Figure 7 In an alternative embodiment, the length S2 of the second support rod 162 in the preset direction is greater than the length S3 of the third support rod 172 in the preset direction. As a result, during the expansion of the stent 10, because the second support rod 162 is larger, its movement in the preset direction is smaller. This helps ensure the positioning effect of the stent 10 during expansion, ensuring that the stent 10 is accurately anchored to the lesion site and reducing the risk of deviation from the lesion site due to the large movement of the second support rod 162.

[0074] Optionally, the ratio of the length S2 of the second support rod 162 in the preset direction to the length S3 of the third support rod 172 in the preset direction is 2-3:1. In this way, during the expansion of the bracket 10, the movement range of the second support rod 162 in the preset direction can be further controlled, and the positioning effect of the bracket 10 during expansion can be further guaranteed.

[0075] Please continue reading. Figure 6 In one embodiment, for the case where the support 10 of the above embodiment includes a first mesh structure layer 15, a second mesh structure layer 16, and a third mesh structure layer 17, the first connecting rod portion and the second connecting rod portion of the first connecting portion 151 form a first included angle θ1, the first connecting rod portion and the second connecting rod portion of the second connecting portion 161 form a second included angle θ2, and the first connecting rod portion and the second connecting rod portion of the third connecting portion 171 form a third included angle θ3. Wherein, the first included angle θ1, the second included angle θ2, and the third included angle θ3 are all between 95° and 120°.

[0076] The first included angle θ1, the second included angle θ2, and the third included angle θ3 are the opening angles of the first connecting part 151, the second connecting part 161, and the third connecting part 171 after the stent 10 is expanded. Through the above method, the first included angle θ1, the second included angle θ2, and the third included angle θ3 are reasonably set, ensuring that the stent 10 has sufficient anchoring force to reliably anchor itself to the lesion site, and also ensuring that the stent 10 has sufficient supporting force to reliably support the valve 20 at the lesion site.

[0077] Furthermore, both the second included angle θ2 and the third included angle θ3 are greater than the first included angle θ1. As mentioned above, when the artificial valve device is delivered using a balloon dilation catheter, the position of the first support rod 152 expands before the positions of the second support rod 162 and the third support rod 172. Therefore, the position of the first support rod 152 does not need to have high rigidity. The smaller first included angle θ1 means that the opening degree of the first connecting part 151 is smaller, which helps to weaken the rigidity of the position of the first support rod 152 and facilitates guiding the expansion action of the stent 10 part where the first support rod 152 is located.

[0078] It should be noted that the angle formed by the first connecting rod and the second connecting rod can be understood as the angle formed by the extension direction of the first connecting rod and the length extension direction of the second connecting rod.

[0079] Please see Figure 8 , Figure 8 This is a schematic diagram of the unfolded structure of the fourth embodiment of the bracket of the present invention.

[0080] In one embodiment, at least two connecting portions are provided between at least two adjacent support rod portions in the first mesh structure layer 15. In other words, with... Figure 4 Compared to the stent 10 shown, in this embodiment, part of the first support rod portion 152 of the first mesh structure layer 15 is omitted. This increases the area of ​​individual mesh openings in the first mesh structure layer 15, which is beneficial for percutaneous coronary intervention, such as facilitating the passage of instruments through the mesh openings in the first mesh structure layer 15.

[0081] Please see Figure 9 , Figure 9 This is a schematic diagram of the unfolded structure of the fifth embodiment of the bracket of the present invention.

[0082] In one embodiment, the mesh structure layer located at the blood inflow end A is the target mesh structure layer. The connecting portion 11 of the target mesh structure layer protrudes towards the blood outflow end B.

[0083] In the above manner, when the stent 10 expands, the connecting portion 11 of the target mesh structure layer will not cause a change in the length of the stent 10 in the preset direction. That is, this embodiment can reduce the amount of change in the axial (i.e., preset direction) length of the stent 10 during the expansion process, which is beneficial to ensure that the artificial valve device of this embodiment has good axial positioning performance, can ensure that the stent 10 is accurately anchored to the lesion site, and reduce the risk of the stent 10 deviating from the lesion site. Therefore, this embodiment can improve the axial positioning performance of the artificial valve device.

[0084] For example, in the case where the support 10 includes a first mesh structure layer 15, a second mesh structure layer 16 and a third mesh structure layer 17, the fourth connecting part 181 is the connecting part 11 of the target mesh structure layer, and the third support rod part 172 of the third mesh structure layer 17 is the support rod part 12 of the target mesh structure layer.

[0085] Furthermore, in this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," "stacked," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0086] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An artificial valve device, said artificial valve device being anchored at the aortic valve to replace a diseased aortic valve, characterized in that, include: The stent has a blood inflow end and a blood outflow end, wherein the blood inflow end and the blood outflow end are arranged opposite to each other along a preset direction; The support includes several mesh structure layers distributed layer by layer along the preset direction. Each mesh structure layer includes a connecting portion and at least two support rod portions. The at least two support rod portions are distributed at intervals along a preset circumferential direction, and the connecting portion is provided between any two adjacent support rod portions. The preset direction is perpendicular to the plane defined by the preset circumferential direction, and the support rod portion is provided with a fixing portion. A valve, wherein the valve is connected to the support via the fixing part; The connecting part includes a first connecting rod part and a second connecting rod part, the first connecting rod part and the second connecting rod part are connected to a first connecting end, and the connecting part and the support rod part are connected to the second connecting end; The mesh structure layer located at the blood outflow end is the target mesh structure layer, and the connecting portion of the target mesh structure layer protrudes towards the blood inflow end; The support rod portion of the target mesh structure layer includes a main support rod and an auxiliary support rod. The main support rod includes a rod body portion and a fixing portion. The fixing portion is closer to the blood flow inlet end relative to the rod body portion. The fixing portion is not provided at the auxiliary support rod. The connecting portion of the target mesh structure layer includes a main connecting portion and an auxiliary connecting portion. The first connecting rod portion of the main connecting portion is connected to the rod body portion, and the auxiliary connecting portion is disposed between adjacent auxiliary support rods. The lengths of the main connecting part and the auxiliary connecting part in the preset direction are both less than the length of the rod part in the preset direction, so as to avoid interference with the fixing part; The length of the main connecting part in the preset direction is less than the length of the auxiliary connecting part in the preset direction, so that the first connecting end of the auxiliary connecting part is closer to the blood flow inlet end relative to the first connecting end of the main connecting part. The included angle formed by the first connecting rod part and the second connecting rod part of the auxiliary connecting part is less than the included angle formed by the first connecting rod part and the second connecting rod part of the main connecting part. That is, the auxiliary connecting part has lower strength, so that the part of the stent at the blood flow outlet end can easily expand.

2. The artificial valve device according to claim 1, characterized in that, The length of the support rod portion of the target mesh structure layer is greater than the length of the support rod portions of the other mesh structure layers besides the target mesh structure layer.

3. The artificial valve device according to claim 1 or 2, characterized in that, The first connecting rod portion and the second connecting rod portion connected in each of the plurality of mesh structure layers form an included angle, the included angle being 95° to 120°.

4. The artificial valve device according to claim 3, characterized in that, The included angle formed by the first connecting rod and the second connecting rod in the target mesh structure layer is smaller than the included angle formed by the first connecting rod and the second connecting rod in other mesh structure layers besides the target mesh structure layer.

5. The artificial valve device according to claim 1 or 2, characterized in that, The target mesh structure layer has at least two connecting parts between at least two adjacent support rods.

6. The artificial valve device according to claim 1 or 2, characterized in that, The length of the second connecting end in the preset circumferential direction is 1mm to 1.5mm.

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