A prosthetic valve
Patent Information
- Application Number
- CN202520687362.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-11
- Publication Date
- 2026-09-25
- Estimated Expiration
- 2035-04-11
AI Technical Summary
[0003]瓣架在上述压握及扩张的过程中，可能会出现时支杆扭曲变形的风险，从而导致人工瓣膜失效
[0014]通过上述设置，将多个所述节点在周向上设置为平齐，无论所述瓣架处于自然状态或收缩状态，多个所述节点在周向上仍然保持平齐；所以在压握过程中(即瓣架从自然状态转换为收缩状态)，所述瓣架的所有节点会随着所述支杆的移动而同步地沿径向移动导致对应的网格单元均匀向内收缩，且所述瓣架的两端(即流入端与流出端)沿所述瓣架的轴向向外同步移动，即位于流出端的端部沿着“流入端-流出端”的方向移动、位于流入端的端部沿着“流出端-流入端”的方向移动，从而形成所述瓣架径向收缩、轴向扩张，以此降低所述瓣架压握装载时，所述支杆因受力不均导致扭曲变形的风险，保证瓣架可被均匀地压握装载。在扩张过程中(即瓣架从收缩状态转换为自然状态)，所述瓣架的所有节点会随着所述支杆的移动而同步地沿径向移动导致对应的网格单元均匀向外扩张，且所述瓣架的两端(即流入端与流出端)沿所述瓣架的轴向向内同步移动，即位于流出端的端部沿着“流出端-流入端”的方向移动、位于流入端的端部沿着“流入端-流出端”的方向移动，从而形成所述瓣架径向扩张、轴向收缩，以此降低所述瓣架扩张时，所述支杆因受力不均导致扭曲变形的风险，保证瓣架可被均匀地扩张。此外，使得相邻两个所述支杆与位于两者之间的所述端部形成至少4个弯曲段，从而在所述瓣架收缩或扩张的过程中利用上述弯曲段减少应力集中程度，将所述应力均匀地分散到上述4个弯曲段中，从而可以避免所述端部断裂，保持所述瓣架整体结构完整，提高所述瓣架的可靠性。
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Figure CN224792452U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and in particular to an artificial valve. Background Technology
[0002] In existing technologies, artificial valves include a valve frame and a valve, with the valve frame comprising multiple struts. During replacement surgery, because the outer diameter of the valve frame in its natural state is relatively large, it is not conducive to delivery. Therefore, it is necessary to first compress the valve frame to cause the artificial valve to contract radially, and then deliver it to the aortic, mitral, or tricuspid valve position via a catheter. Then, components such as a balloon catheter are used to dilate it and restore it to its natural state, thereby completing the valve replacement surgery.
[0003] During the aforementioned compression and expansion process, there is a risk that the strut may twist and deform, leading to the failure of the artificial valve. Utility Model Content
[0004] To solve the above-mentioned technical problems, this utility model provides an artificial valve, which includes a valve frame and leaflets; the leaflets are disposed in the valve frame; the valve frame includes multiple layers of wave rods, each layer of wave rods includes multiple interconnected support rods, and the intersecting parts of two adjacent support rods form nodes; in the natural state and the contracted state, the multiple nodes of the same level are flush with each other in the circumferential direction of the valve frame.
[0005] In some possible embodiments, the petal frame has multiple layers of mesh, each layer of which includes multiple mesh units; the petal frame has at least three mesh units evenly distributed in the circumferential direction.
[0006] In some possible embodiments, the grid cell consists of at least four of the support rods.
[0007] In some possible embodiments, in its natural state, the grid cell consists of four circumferentially arranged support rods and two axially arranged vertical support rods, with the six support rods forming a hexagonal or hexagonal-like structure.
[0008] In some possible embodiments, in its natural state, the grid cell consists of four circumferentially arranged support rods, which form a rhomboid or rhomboid structure.
[0009] In some possible embodiments, the valve frame further has an end, an outflow end, and an inflow end, the end being a node between two adjacent support rods near the outflow end or the inflow end; the end is generally U-shaped, the end including two sides, each side including a first curved segment and a second curved segment, wherein one end of the first curved segment is connected to the first support rod, the other end of the first curved segment is connected to one end of the second curved segment, and the other end of the second curved segment is connected to the other end of another second curved segment.
[0010] In some possible embodiments, the first curved segment has a central angle α, and the second curved segment has a central angle b; in the natural state, the central angle α is greater than the central angle b.
[0011] In some possible embodiments, in the natural state, the width of the grid cell in the circumferential direction is W1; in the contracted state, the width of the grid cell 21 in the circumferential direction is W2; wherein the width W1 is 3-20 times the width W2.
[0012] In some possible embodiments, in the contracted state, after the valve frame is compressed, the grid unit is flat and elongated; the valve frame has an end, the end being a node between two adjacent supports near the outflow end or the inflow end, the radius of the arc segment of the end being r, and the distance between two nodes adjacent to the end being W2, where W2 is greater than 2×r.
[0013] In some possible embodiments, the valve frame also has an outflow end and an inflow end, the end being provided with a groove extending from the arc segment toward the outflow end or the inflow end.
[0014] With the above settings, multiple nodes are aligned circumferentially. Regardless of whether the petal frame is in its natural or contracted state, the multiple nodes remain aligned circumferentially. Therefore, during the compression process (i.e., when the petal frame changes from its natural to its contracted state), all nodes of the petal frame move radially synchronously with the movement of the support rod, causing the corresponding grid cells to contract uniformly inward. Furthermore, both ends of the petal frame (i.e., the inflow end and the outflow end) move outward synchronously along the axial direction of the petal frame. That is, the end located at the outflow end moves along the "inflow end - outflow end" direction, and the end located at the inflow end moves along the "outflow end - inflow end" direction. This results in the petal frame contracting radially and expanding axially, thereby reducing the risk of the support rod twisting and deforming due to uneven force during the compression loading of the petal frame, and ensuring that the petal frame can be uniformly compressed and loaded. During the expansion process (i.e., the petiole frame transitions from a contracted state to a natural state), all nodes of the petiole frame move radially synchronously along with the movement of the support rods, causing the corresponding grid cells to expand uniformly outward. Simultaneously, the two ends of the petiole frame (i.e., the inflow end and the outflow end) move inward synchronously along the axial direction of the petiole frame. Specifically, the end located at the outflow end moves along the "outflow-inflow" direction, and the end located at the inflow end moves along the "inflow-outflow" direction. This results in radial expansion and axial contraction of the petiole frame, reducing the risk of twisting deformation of the support rods due to uneven stress during expansion and ensuring uniform expansion. Furthermore, at least four bending segments are formed between adjacent support rods and the ends located between them. These bending segments reduce stress concentration during the contraction or expansion of the petiole frame, distributing the stress evenly across these four bending segments. This prevents end breakage, maintains the overall structural integrity of the petiole frame, and improves its reliability. Attached Figure Description
[0015] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the present invention and, together with the description, serve to explain the principles of the present invention.
[0016] To more clearly illustrate the technical solutions in the embodiments of this utility model, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0017] Figure 1 This is a schematic diagram of the structure of the artificial valve of this utility model;
[0018] Figure 2 for Figure 1 A schematic diagram of the valve arch in its natural state;
[0019] Figure 3 for Figure 2 A schematic diagram of the unfolded petiole structure;
[0020] Figure 4 for Figure 1 A schematic diagram of the valve arch in a contracted state;
[0021] Figure 5 for Figure 4 A schematic diagram of the unfolded petiole structure;
[0022] Figure 6 for Figure 1 A schematic diagram of an artificial valve implanted into the native aortic valve;
[0023] Figure 7 A schematic diagram of the end portion of another embodiment;
[0024] Figure 8 A schematic diagram of a valve frame according to another embodiment;
[0025] Figure 9 A schematic diagram of a valve frame according to yet another embodiment;
[0026] Figure 10 This is a schematic diagram of a valve frame according to another embodiment. Detailed Implementation
[0027] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.
[0028] In the field of medical devices, "proximal" refers to the end closer to the operator, while "distal" refers to the end farther from the operator. "Axial" refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device; "radial" refers to the direction along the diameter or radius; and "circumferential" refers to the circumferential direction. Those skilled in the art can understand the specific meaning of these terms in this utility model based on the actual situation.
[0029] This invention provides an artificial valve, which includes a valve frame and valve leaflets; the valve leaflets are disposed in the valve frame; the valve frame includes multiple layers of wave rods, each layer of wave rods includes multiple interconnected support rods, and the intersecting portions of two adjacent support rods form nodes; in the natural state and the contracted state, the multiple nodes of the same layer are flush with each other in the circumferential direction of the valve frame.
[0030] With the above settings, multiple nodes are aligned circumferentially. Regardless of whether the petal frame is in its natural or contracted state, the multiple nodes remain aligned circumferentially. Therefore, during the compression process (i.e., when the petal frame changes from its natural to its contracted state), all nodes of the petal frame move radially synchronously with the movement of the support rod, causing the corresponding grid cells to contract uniformly inward. Furthermore, both ends of the petal frame (i.e., the inflow end and the outflow end) move outward synchronously along the axial direction of the petal frame. That is, the end located at the outflow end moves along the "inflow end - outflow end" direction, and the end located at the inflow end moves along the "outflow end - inflow end" direction. This results in the petal frame contracting radially and expanding axially, thereby reducing the risk of the support rod twisting and deforming due to uneven force during the compression loading of the petal frame, and ensuring that the petal frame can be uniformly compressed and loaded.
[0031] During the expansion process (i.e., the petiole frame transitions from a contracted state to a natural state), all nodes of the petiole frame move radially synchronously along with the movement of the support rod, causing the corresponding grid cells to expand outwards uniformly. Simultaneously, both ends of the petiole frame (i.e., the inflow end and the outflow end) move inwards along the axial direction of the petiole frame. Specifically, the end located at the outflow end moves along the "outflow end-inflow end" direction, and the end located at the inflow end moves along the "inflow end-outflow end" direction. This results in radial expansion and axial contraction of the petiole frame, thereby reducing the risk of the support rod twisting and deforming due to uneven force during expansion and ensuring that the petiole frame can expand uniformly.
[0032] Specifically, such as Figure 1-5 As shown, the artificial valve 1 includes a valve frame 2 ( Figure 2 With the valgus frame 2 in its natural state, Figure 4 (With the petiole frame 2 in a contracted state), the petiole frame 2 includes multiple first support rods 211 and second support rods 213. Multiple first support rods 211 in the same layer form a wave bar. The vertically arranged second support rods 213 connect adjacent two layers of wave bars, as well as an inflow end 216 and an outflow end 217. From the outflow end 217 toward the inflow end 216, the adjacent connected portions of the multiple first support rods 211 and the multiple second support rods 213 form a node AH. Multiple nodes H in the same layer are flush with each other in the circumferential direction of the petiole frame 2. Similarly, multiple nodes AG are also flush with each other in the circumferential direction of the petiole frame 2.
[0033] The first support rod 211 is a support rod arranged in the radial direction, while the second support rod 213 is a support rod arranged in the axial direction. The first support rod 211 and the second support rod 213 are alternately arranged on the petal frame 2.
[0034] Therefore, during the compression process of the valve frame 2, all nodes AH of the valve frame 2 move radially synchronously with the movement of the first support rod 211 and the second support rod 213, causing the corresponding grid units to shrink inward uniformly, and the two ends of the valve frame 2 expand axially along the valve frame 2; during the expansion process of the valve frame 2, all nodes AH of the valve frame 2 expand radially synchronously, and the two ends of the valve frame 2 (i.e., the inflow end and the outflow end) shrink axially along the valve frame 2, the end located at the outflow end moves along the "outflow end-inflow end" direction, and the end located at the inflow end moves along the "inflow end-outflow end" direction, thereby forming the radial shrinkage and axial expansion of the valve frame 2; thus, it can be ensured that the support rod 211 is subjected to uniform force during the above shrinkage or expansion process, shrinking or expanding in a predetermined manner, without twisting or deformation causing the artificial valve 1 to fail.
[0035] Furthermore, regardless of whether it is during contraction or expansion, since the node AH is aligned with the circumferential direction of the petal frame 2, the second support rod 213 is always parallel to the axial direction of the petal frame 2. Therefore, during the compression or expansion of the petal frame 2, the second support rod 213 will not deform, thereby providing support for the first support rod 211 during the compression or expansion process, ensuring that the compression or expansion process can be carried out smoothly.
[0036] Please refer to the following: Figure 3 From the outflow end 217 toward the inflow end 216, the petal frame 2 has a first grid unit 21, a second grid unit 22, a third grid unit 23 and a fourth grid unit 24, and multiple grid units in the same layer form a grid; the petal frame 2 has at least 3 grid units evenly distributed in the circumferential direction.
[0037] The first grid unit 21 and the fourth grid unit 24 are each composed of four first support rods 211 and two second support rods 213, and their overall shape is hexagonal or hexagonal-like; the second grid unit 22 and the third grid unit 23 are each composed of four first support rods 211, and their overall shape is quadrilateral or quadrilateral-like.
[0038] With the above settings, the first grid unit 21, the second grid unit 22, the third grid unit 23 and the fourth grid unit 24 can freely switch between the natural state and the contracted state, thereby facilitating the switching of the petal frame 2 between the natural state and the contracted state.
[0039] The petal frame 2 also has an end portion 212, which is formed by the intersecting portions of two adjacent first support rods 211 near the outflow end or the inflow end (forming the node A and the node H). The end portion 212 is generally U-shaped and includes two symmetrically arranged sides, each side including a first curved segment 2121 and a second curved segment 2122. One end of the first curved segment 2121 is connected to the first support rod 211, the other end of the first curved segment 2121 is connected to one end of the second curved segment 2122, and the other end of the second curved segment 2122 is connected to the other end of the other second curved segment 2122.
[0040] With the above arrangement, at least four bending segments are formed between two adjacent first support rods 211 and the end 212 located between them. In this way, the bending segments are used to reduce the stress concentration during the contraction or expansion of the petal frame 2, and the stress is evenly distributed to the four bending segments. This can prevent the end 212 from breaking, maintain the integrity of the overall structure of the petal frame 2, and improve the reliability of the petal frame 2.
[0041] Furthermore, in some possible embodiments, the first curved segment 2121 has a central angle α, and the second curved segment 2122 has a central angle β; in the natural state, the central angle α is greater than the central angle β.
[0042] With the above settings, the central angle a is greater than the central angle b, which can improve the overall stability of the end 212. During the expansion process, the second bending section 2122 can limit the expansion stroke of the two adjacent first support rods 211, thereby avoiding the first grid unit 21 and the second grid unit 24 from being twisted and deformed due to excessive expansion of the two adjacent first support rods 211, which would cause the artificial valve 1 to fail.
[0043] Please see Figure 3 , Figure 5 In its natural state, the width of the first grid cell 21 in the circumferential direction is W1 (i.e., the distance between two adjacent first support rods 211 or the distance between two adjacent second support rods 213); in its contracted state, the width of the first grid cell 21 in the circumferential direction is W2 (i.e., the distance between two nodes B or G adjacent to the end); wherein, generally, the width W1 is 3-20 times the width W2; preferably, the width W1 is 4-15 times the width W2; more preferably, the width W1 is 5-10 times the width W2.
[0044] With the above settings, the width W1 in the natural state is much larger than the width W2 in the contracted state; the larger width W1 can ensure that the valve frame 2 has sufficient radial support force after it is fully expanded, while the smaller width W2 can ensure that the valve frame 2 is easy to deliver through the catheter after it is contracted.
[0045] In some possible embodiments, when the petal frame 2 is compressed in the contracted state, the first grid unit 21 and the fourth grid unit 24 are flat and elongated, wherein the radius of the arc segment 214 of the end 212 is r, and the distance between two adjacent nodes G is W2, where W2 is greater than 2×r.
[0046] With the above settings, in the contracted state, the distance W2 between two adjacent nodes G is greater than twice r, making the fourth grid unit 24 a flat and elongated structure; similarly, the first grid unit 21 with the above settings is also a flat and elongated structure. This allows the first grid unit 21 and the fourth grid unit 24 to be expanded by a smaller external force, so the initial inflation pressure of the balloon used to expand the valve frame 2 can be smaller, thereby reducing the expansion time of the valve frame 2 and facilitating its smooth expansion; in addition, it can also prevent the balloon from rupturing due to excessive inflation pressure during the expansion of the valve frame 2, avoiding device failure and improving device reliability.
[0047] like Figure 6 As shown, in some possible embodiments, the artificial valve 1 can be implanted into the aortic annulus via the aorta 5 to replace the aortic valve. Of course, the artificial valve 1 can also be implanted into the mitral or tricuspid annulus to replace the mitral or tricuspid valve, depending on the actual situation.
[0048] like Figure 7 As shown, in some possible embodiments, the sidewall of the end 212a is provided with a groove 215, which extends from the arc segment 214 toward the outflow end 217 or the inflow end 216.
[0049] With the above configuration, the end portion 212a can better absorb the force from the two adjacent first support rods 211 during contraction or expansion. At the same time, by utilizing the first curved section 2121, the second curved section 2122, and the arc 214, the stress during contraction or expansion is distributed more evenly, ensuring that the end portion 212a will not be damaged due to stress concentration, and ensuring the reliability of the artificial valve 1.
[0050] like Figure 8As shown, in some possible embodiments, the petal frame 2a has four layers of mesh, wherein the first mesh unit 21 near the outflow end 217 is composed of four first support rods 211 and two second support rods 213, and the overall shape is hexagonal or quasi-hexagonal; the mesh units 22a of the remaining three layers of mesh are all composed of four first support rods 211, and the overall shape is quadrilateral or quasi-quadrilateral.
[0051] like Figure 9 As shown, in some possible embodiments, the petal frame 2b has four layers of mesh, wherein the first mesh unit 21 near the inflow end 216 is composed of four first support rods 211 and two second support rods 213, and the overall shape is hexagonal or quasi-hexagonal; the mesh units 22a of the remaining three layers of mesh are all composed of four first support rods 211, and the overall shape is quadrilateral or quasi-quadrilateral.
[0052] like Figure 10 As shown, in some possible embodiments, the petal frame 2c has four layers of mesh, wherein each layer of mesh unit 22a is composed of four first support rods 211, and the overall shape is quadrilateral or quadrilateral.
[0053] Please refer to the following: Figure 1 The artificial valve also includes a cover 4, which is sutured to the inner and / or outer surface of the valve frame. The cover 4 can be made of materials such as polytetrafluoroethylene (PTFE), polypropylene (PP), polyethylene (PE), and polyethylene terephthalate (PET).
[0054] The leaflet 3 is sutured to the covering membrane 4 and is sutured into the central channel inside the valve frame 2. The leaflet 4 acts as a one-way valve, allowing blood to flow in only one direction. The leaflet 3 can be made of animal-derived materials, such as bovine or porcine pericardium; it can also be made of polymer materials.
[0055] To ensure that the petiole frame 2 has good support and deformation plasticity, its material can be stainless steel, cobalt-chromium alloy, etc.
[0056] It should be noted that the terms "one embodiment," "embodiment," "exemplary embodiment," "some embodiments," etc., mentioned in the specification indicate that the described embodiment may include a specific feature, structure, or characteristic, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, implementing such a feature, structure, or characteristic in conjunction with other embodiments, whether explicitly described or not, is within the knowledge scope of those skilled in the art.
[0057] It should be readily understood that the terms “on,” “above,” and “on top of” in this disclosure should be interpreted in the broadest possible sense, such that “on” means not only “directly on something” but also “on something” with an intermediate feature or layer therebetween, and that “above” or “on top of” means not only “on top of something” but also “on top of something” without an intermediate feature or layer therebetween (i.e., directly on something).
[0058] Furthermore, for ease of explanation, spatially relative terms such as "below," "below," "under," "above," and "above" may be used to describe the relationship of one element or feature relative to other elements or features as shown in the figures. Spatially relative terms are intended to encompass different orientations of the device in use or operation other than those shown in the figures. The device may have other orientations (rotated 90 degrees or in other orientations), and the spatially relative descriptive terms used herein may be interpreted accordingly.
[0059] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.
[0060] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model 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 therein. Such 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 this utility model.
Claims
1. An artificial valve, characterized in that, The artificial valve includes a valve frame and leaflets; the leaflets are disposed within the valve frame; the valve frame includes multiple layers of wave rods, each layer of wave rods including multiple interconnected support rods, the intersection of two adjacent support rods forming a node; in the natural and contracted states, multiple nodes of the same level are flush with each other in the circumferential direction of the valve frame; the valve frame also has an end, an outflow end, and an inflow end, the end being the node between two adjacent support rods near the outflow end or the inflow end; the end is generally U-shaped, the end including two sides, each side including a first curved segment and a second curved segment, wherein one end of the first curved segment is connected to a support rod, the other end of the first curved segment is connected to one end of the second curved segment, and the other end of the second curved segment is connected to the other end of another second curved segment; the first curved segment has a central angle α, and the second curved segment has a central angle b; in the natural state, the central angle α is greater than the central angle b.
2. The artificial valve according to claim 1, characterized in that, The petal frame has multiple layers of mesh, each layer of which includes multiple mesh units; the petal frame has at least three mesh units evenly distributed in the circumferential direction.
3. The artificial valve according to claim 2, characterized in that, The grid cell consists of at least four of the aforementioned support rods.
4. The artificial valve according to claim 3, characterized in that, In its natural state, the grid unit consists of four circumferentially arranged support rods and two axially arranged vertical support rods, with the six support rods forming a hexagonal or near-hexagonal structure.
5. The artificial valve according to claim 3, characterized in that, In its natural state, the grid unit consists of four circumferentially arranged support rods, which form a rhomboid or rhomboid structure.
6. The artificial valve according to claim 2, characterized in that, In its natural state, the width of the grid cell in the circumferential direction is W1; in its contracted state, the width of the grid cell in the circumferential direction is W2; wherein the width W1 is 3-20 times the width W2.
7. The artificial valve according to claim 6, characterized in that, In the contracted state, after the petal frame is compressed, the grid unit is flat and elongated; the radius of the arc segment at the end is r, and the distance between two nodes adjacent to the end is W2, where W2 is greater than 2×r.
8. The artificial valve according to claim 7, characterized in that, The end is provided with a groove, which extends from the arc segment toward the outflow end or the inflow end.