Anchoring stent and prosthetic valve device
Patent Information
- Application Number
- CN202611308190.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-08-26
- Publication Date
- 2026-10-23
AI Technical Summary
[0003]目前,在房室瓣置换术研究领域,部分产品采用瓣叶外锚定环构建方式,如单根丝线多圈环绕式构建,这种构建方式为贴合后续人工锚定支架,其直径尺寸较小,导致在初圈环绕时难以单次越过并环绕全部腱索,操作者常需反复尝试,在此过程中,丝线极易误入腱索间隙,不得不进行反向旋转退回,从而显著延长了操作时间
[0011]本发明的锚定支架采用双层导管同向逐层且分段的释放成型方式,锚定结构释放时各锚定段周向展开穿越腱索,可以提供较大的穿越范围,在支架本体自扩张完成前,多个所述锚定段沿周向依次可滑动搭接,将原生房室瓣瓣叶夹持于锚定段与支架外壁之间;支架本体自扩张后各锚定段沿切向逐渐扩张并闭锁;支架本体与锚定结构一体连接在定型时即完成对位,也避免了多段成环方式的定位问题,并进一步增加了对原生房室瓣瓣叶的夹持力。在后续人工瓣膜扩张时各锚定段进一步互相牵拉锁紧锚定原生房室瓣瓣叶。
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Figure CN122954580A_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to an anchoring stent and an artificial valve device. Background Technology
[0002] Atrioventricular valve regurgitation (AVR) encompasses mitral regurgitation (MR) and tricuspid regurgitation (TR), and is one of the most common valvular heart diseases in clinical practice. With the accelerating aging of the global population, the disease burden of AVR is becoming increasingly prominent. Transcatheter AVR interventional therapy has made significant progress and has become an important treatment option for patients who cannot tolerate surgery or are at high risk of surgery. Among these, transcatheter edge-to-edge repair is the most mature interventional technique, and its evidence-based system is continuously being improved. However, it can only alleviate, not effectively eradicate, MR and TR. Compared to edge-to-edge repair, transcatheter mitral valve replacement and tricuspid valve replacement offer the core advantage of providing a more thorough and longer-lasting elimination of valvular regurgitation, especially suitable for patients with complex anatomy. In other words, replacement surgery, with its more thorough correction of valvular function, provides a crucial alternative for patients with complex anatomy.
[0003] Currently, in the field of atrioventricular valve replacement research, some products employ external anchoring ring construction methods, such as multi-turn wrapping with a single suture. This method, designed to fit the subsequent artificial anchoring stent, has a relatively small diameter, making it difficult to pass over and wrap around all the chordae tendineae in a single turn during the initial wrapping. Operators often need to attempt repeatedly, and during this process, the suture is easily misplaced into the chordae tendineae gap, necessitating reverse rotation and retraction, significantly prolonging the operation time. Other methods, such as bidirectional wrapping anchoring ring formation, are more complex. Precise positioning in both directions within the active ventricle of the heart is difficult, resulting in a longer surgical duration. Furthermore, during subsequent artificial valve stent implantation, the anchoring ring implantation catheter remains in the coronary artery, significantly impacting overall cardiac activity. Therefore, a product that integrates the anchoring ring with the stent, has a larger wrapping range, and provides stable ring formation is needed. Summary of the Invention
[0004] Therefore, it is necessary to provide an anchoring stent to address the above problems, which can more accurately pass over the chordae tendineae when releasing them, reducing the risk of a single alloy wire accidentally entering the chordae tendineae gap due to continuous multiple turns, thereby shortening the implantation and release time.
[0005] This application provides an anchoring bracket, including a bracket body and an anchoring structure. The anchoring structure includes a plurality of anchoring segments arranged circumferentially around the bracket body, such that the anchoring structure surrounds the outer periphery of the bracket body, and each anchoring segment is connected to the bracket body. Each anchoring segment includes an anchoring portion extending circumferentially along the bracket body, the anchoring portion being connected to the bracket body. The anchoring portion includes a plurality of anchoring rods arranged axially spaced along the bracket body, at least a portion of the anchoring rods being connected to the bracket body.
[0006] Understandably, because the anchoring structure includes multiple anchoring segments that encircle the circumference of the stent body, it can grip the native atrioventricular valve leaflets by rotating these segments into a loop. This increases the gripping range of the anchoring structure and disperses the gripping stress of a single anchoring segment, thereby maintaining multiple anchoring segments more stably anchored to the native atrioventricular valve leaflets. Furthermore, during release, each anchoring segment can independently and precisely pass over the chordae tendineae until the entire anchoring structure surrounds the outer periphery of the chordae tendineae. This reduces the risk of a single alloy wire accidentally entering the chordae tendineae gap due to continuous multi-turn wrapping, thus shortening the implantation and release time. Simultaneously, compared to single-wire anchoring, by setting multiple anchoring rods spaced axially along the stent body, the clamping of the native atrioventricular valve leaflets by the anchoring part is more uniform and reliable, reducing the risk of tissue damage caused by single-point stress concentration. Moreover, the axial gap between multiple anchor rods provides space for the original atrioventricular valve leaflets. When the original atrioventricular valve leaflets are clamped, the contact surface with the original atrioventricular valve leaflets is increased, which is beneficial for long-term fixation and improves the structural stability of the anchoring part.
[0007] In some embodiments, the multiple anchoring segments can be released in the same direction.
[0008] In some embodiments, multiple anchoring segments can be released simultaneously.
[0009] In some embodiments, the support body and the anchoring structure can be released in layers.
[0010] In some embodiments, the anchoring structure is released before the support body. After the anchoring structure is released, the plurality of anchoring segments overlap sequentially in the circumferential direction; after the support body is released, the anchoring segments are locked together by the radial expansion of the support body.
[0011] The anchoring stent of this invention employs a double-layered catheter, with each layer unfolding and segmented in the same direction during release. When the anchoring structure is released, each anchoring segment expands circumferentially to traverse the chordae tendineae, providing a larger traversal range. Before the stent body completes self-expansion, multiple anchoring segments can slide and overlap sequentially circumferentially, clamping the native atrioventricular valve leaflets between the anchoring segments and the outer wall of the stent. After the stent body self-expands, each anchoring segment gradually expands tangentially and locks in place. The stent body and anchoring structure are integrally connected, achieving alignment during shaping, thus avoiding the positioning problems of multi-segment ring-forming methods and further increasing the clamping force on the native atrioventricular valve leaflets. During subsequent artificial valve dilation, each anchoring segment further pulls and locks against the native atrioventricular valve leaflets.
[0012] In some embodiments, each of the anchoring segments is integrally connected to the support body, eliminating the connection interface, which can improve the long-term stability and fatigue resistance of the anchoring structure in the body, and also eliminates the need for additional connectors, which helps to reduce the compression profile of the anchoring support, making release smoother and operation more controllable.
[0013] In some embodiments, each of the anchoring rods in each of the anchoring portions is connected to the support body.
[0014] In some embodiments, any two adjacent anchor rods in each anchoring section are connected along the axial direction of the support body, and at least one of the plurality of anchor rods is connected to the support body.
[0015] In some embodiments, the anchoring portion further includes a reinforcing rod connected between any two adjacent anchoring rods along the axial direction of the support body.
[0016] In some embodiments, the reinforcing rod is straight, wavy, zigzag, V-shaped, or X-shaped.
[0017] In some embodiments, the stent body has an inflow end and an outflow end that are arranged opposite to each other and spaced apart along its own axial direction, the inflow end being positioned toward the atrium and the outflow end being positioned toward the ventricle, and the anchoring rod being connected to the outflow end or to a region of the stent body near the outflow end.
[0018] In some embodiments, the end of the anchor rod is provided with a connecting rod extending axially along the support body, the connecting rod being used to connect with the support body, and the connecting rod and the support body having a gap along the support body.
[0019] In some embodiments, any two adjacent anchoring segments can be locked along the circumference of the support body.
[0020] In some embodiments, each anchoring segment further includes a locking part and a mating part. Along the circumference of the support body, one end of each anchoring segment is provided with the locking part, and the other end is provided with the mating part. Along the circumference of the support body, in any two adjacent anchoring segments, the mating part of one anchoring segment and the locking part of the other anchoring segment are locked together.
[0021] In some embodiments, the locking part and the mating part are configured to be detachably locked to each other. The locking part and the mating part are not limited to a specific mating form, as long as they can be detachably locked to each other.
[0022] In some embodiments, the mating part is configured to bidirectionally limit the locking part in the axial direction, which can improve the axial stability of the anchoring section during and after locking and prevent displacement.
[0023] In some embodiments, the locking portion is angled to the anchoring portion.
[0024] In some embodiments, the included angle between the locking part and the anchoring part is 100°-170°.
[0025] In some embodiments, the locking part and the anchoring part are rounded, and the radius of curvature of the rounded part is 1mm-3mm.
[0026] In some embodiments, the anchoring section further includes a connecting portion connected to the anchoring portion, the connecting portion being connected to the support body.
[0027] In some embodiments, at least a portion of the connecting portion forms the mating portion.
[0028] In some embodiments, the locking part includes a hook disposed at one end of the anchoring part.
[0029] In some embodiments, the claw includes a claw body and a fixed arm connected to the claw body, the fixed arm being fixed to the anchoring portion, and the claw body bending from one end of the fixed arm away from the anchoring portion toward a side away from the support body.
[0030] In some embodiments, the fixing arm is positioned close to the support body.
[0031] In some embodiments, the distance between the fixed arm near the end of the claw body and the support body is smaller than the distance between the anchoring part and the support body.
[0032] In some embodiments, the anchoring section further includes a traction portion connected to the locking portion, the traction portion being capable of driving the locking portion to move.
[0033] In some embodiments, the traction portion is configured to release later than the locking portion and the anchoring portion, and the locking portion can be driven to move toward a side closer to the support body before the traction portion is released.
[0034] In some embodiments, the traction unit includes a traction plate and a connecting arm connected to the traction plate, the connecting arm being connected to the locking unit.
[0035] In some embodiments, the anchoring support also includes a flange structure located on the atrial side.
[0036] In some embodiments, the flange structure and the support body are flexibly connected.
[0037] In some embodiments, the anchoring bracket further includes an outer skirt and a connecting skirt, the outer skirt being connected to the bracket body and the connecting skirt connecting the outer skirt and the flange structure.
[0038] This application also provides an artificial valve device, including an artificial valve and the above-mentioned anchoring bracket, wherein the bracket body of the anchoring bracket is provided with a channel, and at least a portion of the artificial valve is disposed within the channel.
[0039] In some embodiments, the artificial valve is pressed onto the stent body. Attached Figure Description
[0040] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0041] Figure 1 This is a first schematic diagram of an anchoring bracket provided in an embodiment of this application;
[0042] Figure 2 This is a second schematic diagram of an anchoring bracket provided in an embodiment of this application;
[0043] Figure 3 This is a simplified diagram showing the clockwise release of each anchoring segment in an anchoring bracket provided in an embodiment of this application;
[0044] Figure 4 A simplified diagram illustrating the counterclockwise release of each anchoring segment in an anchoring bracket provided in an embodiment of this application;
[0045] Figure 5A schematic diagram illustrating the release of the anchoring structure in an anchoring bracket provided in an embodiment of this application;
[0046] Figure 6 This is a schematic diagram of the anchoring structure in an anchoring bracket provided in an embodiment of this application after release;
[0047] Figure 7 A schematic diagram showing the support body not expanding after the anchoring structure is released, according to an embodiment of this application;
[0048] Figure 8 This is a schematic diagram showing the anchoring bracket provided in one embodiment of this application cut and laid flat.
[0049] Figure 9 A schematic diagram of an anchoring bracket provided in another embodiment of this application;
[0050] Figure 10 for Figure 9 A schematic diagram showing the anchor bracket after release;
[0051] Figure 11 A schematic diagram of an anchoring bracket provided in yet another embodiment of this application;
[0052] Figure 12 for Figure 11 A schematic diagram of the anchoring section in the provided anchoring bracket;
[0053] Figure 13 A schematic diagram of an anchoring bracket provided in another embodiment of this application;
[0054] Figure 14 This is a schematic diagram of the flange structure in an anchoring bracket provided in an embodiment of this application;
[0055] Figure 15 A schematic diagram illustrating the implantation of an artificial valve device according to an embodiment of this application;
[0056] Figure 16 for Figure 15 A magnified view of a section at point A in the middle;
[0057] Figure 17 This is a schematic diagram of an artificial valve device provided in an embodiment of this application;
[0058] Figure 18 for Figure 17 A schematic diagram of the artificial valve in the provided artificial valve device.
[0059] Figure label:
[0060] 100. Anchoring support; 110. Support body; 111. Fixing frame; 120. Anchoring structure; 121. Anchoring section; 121a. First anchoring section; 121b. Second anchoring section; 121c. Third anchoring section; 130. Outer skirt; 140. Connecting skirt; 150. Flange structure; 160. Temporary leaflet; 200. Artificial valve; 210. Inner skirt; 220. Artificial leaflet; 230. Inner support; 300. Double-layer catheter; 310. Inner layer Catheter; 320, outer catheter; 1000, artificial valve device; 1101, channel; 1102, inflow end; 1103, outflow end; 1201, anchor rod; 1202, reinforcing rod; 1203, connecting rod; 1211, connecting part; 1212, anchoring part; 1213, locking part; 1213a, claw body; 1213b, fixing arm; 1214, mating part; 1215, traction part; 2000, chordae tendineae; 3000, original atrioventricular valve leaflet. Detailed Implementation
[0061] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.
[0062] It should be noted that when a component is referred to as being "fixed to," "set on," or "located on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.
[0063] 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 indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.
[0064] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "over," and "on top" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.
[0065] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.
[0066] Please see Figure 1 , Figure 15 and Figure 16 One embodiment of this application provides an anchoring support 100, including a support body 110 and an anchoring structure 120, the anchoring structure 120 surrounding the outer periphery of the support body 110. The support body 110 forms a channel extending along its own axial direction, and a temporary leaflet can be provided in the channel. The anchoring structure 120 is mainly used to anchor the native atrioventricular valve leaflets, specifically the native mitral valve leaflets. Of course, the anchoring structure 120 can also be used to anchor the native tricuspid valve leaflets, depending on actual needs; this is only an example.
[0067] In related technologies, when anchoring chordae tendineae using an external anchoring ring on the leaflet, a single alloy wire is often used to wrap around the chordae tendineae multiple times for anchoring. This makes it difficult for the alloy wire to pass over and wrap around the entire chordae tendineae in one go during the initial wrapping. There is a risk of the alloy wire accidentally entering the gaps between the chordae tendineae during the entire wrapping process, requiring multiple reverse rotations to return it, thus resulting in an excessively long operation time.
[0068] Based on this, please refer to Figures 1 to 8 The anchoring structure 120 in the anchoring bracket 100 provided in this application includes a plurality of anchoring sections 121 arranged around the bracket body 110 in the circumferential direction. The plurality of anchoring sections 121 surround the outer periphery of the bracket body 110, and each anchoring section 121 is connected to the bracket body 110.
[0069] It should be noted that the multiple anchoring segments 121 are arranged around the circumference of the support body 110, meaning that each anchoring segment 121 can be arranged in an arc shape extending around the circumference of the support body 110 and is arranged around the outer periphery of the support body 110. This causes the anchoring structure 120 to be arranged around the outer periphery of the support body 110 as a whole, fixing the original atrioventricular valve leaflet 3000 between the anchoring structure 120 and the support body 110.
[0070] In actual use, the support body 110 and the anchoring structure 120 in the anchoring bracket 100 can be released in layers; that is, they are not released simultaneously, but separately. For details, refer to... Figures 5 to 6 The anchoring stent 100 can be released in layers via a double-layer conduit 300. The double-layer conduit 300 includes an inner conduit 310 and an outer conduit 320 sleeved outside the inner conduit 310. The outer conduit 320 is used to release the anchoring structure 120, and the inner conduit 310 is used to release the stent body 110, thereby reducing interference between the anchoring structure 120 and the stent body 110 during release and facilitating the capture of the original atrioventricular valve leaflets 3000. The anchoring structure 120 is released before the stent body 110. Specifically, when the outer conduit 320 is withdrawn, each anchoring segment 121 in the anchoring structure 120 first expands circumferentially before the stent body 110 and passes through the chordae tendineae 2000. After the anchoring structure 120 is released, the entire anchoring structure 120 is moved to the side closer to the native atrioventricular valve leaflet 3000. Then, the inner conduit 310 is withdrawn to release the stent body 110. During the gradual expansion process after the stent body 110 is released, it can cooperate with the anchoring structure 120 to clamp the native atrioventricular valve leaflet 3000. In this process, because the anchoring structure 120 includes multiple anchoring segments 121 arranged circumferentially around the stent body 110, the native atrioventricular valve leaflet 3000 can be clamped by the multiple anchoring segments 121 being wound into a ring, thereby increasing the clamping range of the anchoring structure 120 and dispersing the clamping stress of a single anchoring segment 121, thus maintaining multiple anchoring segments 121 more stably anchored to the native atrioventricular valve leaflet 3000. Furthermore, by setting multiple independent anchoring segments 121, this application facilitates each anchoring segment 121 to independently and accurately pass through the tendon cord 2000, reducing the risk of a single alloy wire accidentally entering the gap of the tendon cord 2000 due to continuous multi-turn wrapping, thereby reducing the duration.
[0071] Moreover, each anchoring segment 121 is first precisely positioned and fully expanded to capture the native atrioventricular valve leaflets 3000. After confirming that the native atrioventricular valve leaflets 3000 have been effectively clamped, the stent body 110 is released. Finally, the stent body 110 is further radially expanded through post-expansion, thereby tightly clamping the native atrioventricular valve leaflets 3000 between the anchoring structure 120 and the outer wall of the stent body 110. This step-by-step operation not only changes passive adhesion to active clamping, but also provides an opportunity to verify the clamping effect and fine-tune the position before the stent is fully released. At the same time, the clamping tightness can be further strengthened through the post-expansion step, which significantly improves the success rate of capturing the native atrioventricular valve leaflets 3000 and reduces the risk of perivalvular leakage due to incomplete clamping or loose adhesion.
[0072] When the anchoring structure 120 is released, multiple anchoring segments 121 can be released in the same direction and coiled into a ring shape. For example, each anchoring segment 121 can be released clockwise or counterclockwise. Taking an anchoring structure 120 comprising three anchoring segments 121 as an example, the three anchoring segments 121 can be arranged around the circumference of the support body 110 after release. The three anchoring segments 121 can be a first anchoring segment 121a, a second anchoring segment 121b, and a third anchoring segment 121c. The three anchoring segments 121 are arranged in the same direction from end to end along the circumference of the support body 110, that is: the first end of the first anchoring segment 121a faces the tail end of the third anchoring segment 121c, the first end of the third anchoring segment 121c faces the tail end of the second anchoring segment 121b, and the first end of the second anchoring segment 121b faces the tail end of the first anchoring segment 121a. In this design, the first anchoring section 121a has an initial end of A1 and an initial end of B1; the second anchoring section 121b has an initial end of A2 and an initial end of B2; and the third anchoring section 121c has an initial end of A3 and an initial end of B3. Figure 2 As shown, the three anchoring segments 121 are arranged in a clockwise direction with their ends in the same direction. Figure 3 As shown, the three anchoring segments 121 are arranged counterclockwise with their ends in the same direction. During release, when the anchoring structure 120 is released through the outer conduit 320, the first anchoring segment 121a, the second anchoring segment 121b, and the third anchoring segment 121c are all released independently from the first end to the last end, and each passes over the chordae tendineae 2000, and then coils into a ring around the outer periphery of the chordae tendineae 2000, in preparation for subsequent cooperation with the stent body 110 to clamp the original atrioventricular valve leaflets 3000.
[0073] Furthermore, multiple anchoring segments 121 can be released simultaneously. That is, multiple anchoring segments 121 can be released simultaneously and in the same direction, ensuring that each anchoring segment 121 can unfold synchronously to uniformly and stably surround the outer periphery of the chordae tendineae 2000 at the moment of release. This reduces the risk of tilting or twisting of the anchoring structure 120 due to uneven force on one side, and even tilting or twisting of the support body 110 during expansion. Simultaneously, this arrangement ensures that the force of each anchoring segment 121 is evenly distributed to the original atrioventricular valve leaflets 3000, thereby improving anchoring stability and support stability.
[0074] The anchoring structure 120 and the support body 110 are made of materials with self-expanding properties, such as shape memory alloys like nickel-titanium alloys.
[0075] It should be added that the anchoring structure 120 may also include four anchoring segments 121, five anchoring segments 121, etc., which are only examples here.
[0076] In some specific embodiments, the anchoring structure 120 can be made by integrally weaving a single nickel-titanium wire and then heat-setting it, or it can be made by integrally cutting a nickel-titanium tube. This is only an example.
[0077] Please see Figure 1 , Figure 2 , Figure 7 and Figure 8 In some embodiments, each anchoring segment 121 includes an anchoring portion 1212 extending circumferentially along the support body 110, the anchoring portion 1212 being connected to the support body 110. The anchoring portion 1212 is the part mainly surrounding and anchoring the original atrioventricular valve leaflets. After release, the anchoring portion 1212 is arc-shaped extending circumferentially along the support body 110 to maintain stable circumferential anchorage to the original atrioventricular valve leaflets.
[0078] Furthermore, the anchoring portion 1212 includes a plurality of anchoring rods 1201 arranged at intervals along the axial direction of the support body 110, with at least some of the anchoring rods 1201 connected to the support body 110. That is, by using a plurality of anchoring rods 1201, the anchoring range of each anchoring portion 1212 along the axial direction of the support body 110 can be increased, thereby improving anchoring reliability; and, since at least some of the anchoring rods 1201 can be connected to the support body 110, the connection reliability between the anchoring segment 121 and the support body 110 is increased. Each anchoring rod 1201 in each anchoring portion 1212 can also be connected to the support body 110. For example, each anchoring segment 121 includes two anchoring rods 1201 arranged at intervals along the axial direction of the support body 110. The support body 110 has a plurality of connection points arranged at intervals along its circumference, and each anchoring rod 1201 can be connected to a corresponding connection point. Of course, the anchoring section 121 may also include three anchor rods 1201, four anchor rods 1201, or even more anchor rods 1201; this is just an example.
[0079] In summary, compared to anchoring with a single metal wire, this embodiment, by setting multiple anchoring rods 1201 spaced axially along the support body 110, can ensure that the anchoring part 1212 clamps the original atrioventricular valve leaflets more evenly and reliably, reducing the risk of tissue damage caused by single-point stress concentration. Furthermore, the axial gaps between the multiple anchoring rods 1201 also provide accommodating space for the original atrioventricular valve leaflets, increasing the contact surface between the anchoring part 1212 and the original atrioventricular valve leaflets when they are clamped, which is beneficial for long-term fixation and improves the structural stability of the anchoring part 1212.
[0080] It should be added that the axial direction of the aforementioned support body 110 is the Z-axis direction, and the circumferential direction of the support body 110 is the S-axis direction.
[0081] In other embodiments, in each anchoring part 1212, any two adjacent anchor rods 1201 are connected along the axial direction of the support body 110, and at least one of the multiple anchor rods 1201 is connected to the support body 110. That is, the overall structural stability of the anchoring part 1212 can be improved by connecting any two adjacent anchor rods 1201, avoiding deformation or displacement of a single anchor rod 1201 due to external forces; and, when at least one anchor rod 1201 is connected to the support body 110, the number of connection points between the anchoring part 1212 and the support body 110 is reduced while ensuring the structural stability of the anchoring part 1212 itself, thereby reducing the processing difficulty. Of course, each anchor rod 1201 can be connected to the support body 110, or two adjacent anchor rods 1201 can be grouped together, with one anchor rod 1201 in the group connected to the support body 110. The key is to improve the connection reliability with the support body 110 while ensuring the structural stability of the anchoring part 1212 itself, thereby improving the overall structural stability of the anchoring support 100. This is merely an example.
[0082] like Figure 2 As shown, in some embodiments, the anchoring part 1212 further includes a reinforcing rod 1202 connecting any two adjacent anchor rods 1201 along the axial direction of the support body 110. That is, the reinforcing rod 1202 enhances the structural stability between any two adjacent anchor rods 1201, preventing deformation or displacement of the anchor rods 1201 under external forces, thereby improving the overall structural strength of the anchoring part 1212. If the arc length of the anchor rod 1201 along the circumference of the support body 110 is large, multiple reinforcing rods 1202 can be spaced apart along the circumference of the support body 110 to improve structural stability. If the arc length of the anchor rod 1201 along the circumference of the support body 110 is small, reinforcing rods 1202 may not be provided, or only one reinforcing rod 1202 may be provided in the middle. This is merely an example.
[0083] The reinforcing rod 1202 can be arranged in a V-shape with a 90-degree rotation, and when multiple reinforcing rods 1202 are provided, the openings of the V-shapes in the multiple reinforcing rods 1202 face the same direction. This arrangement can decompose the shear force and convert it into axial tensile and compressive forces, thereby enabling the anchoring section 121 to better withstand the shear force and improve the torsional resistance of the anchoring section 121. The reinforcing rod 1202 has a rounded corner at the included angle of the V-shape to reduce stress concentration. Alternatively, the reinforcing rod 1202 can also be straight, with its length extending along the axial direction of the bracket body 110; or, the reinforcing rod 1202 can be set in a wavy, zigzag, or X-shaped form, as long as it can improve the structural strength of the anchoring part 1212. This is only an example.
[0084] Please continue reading. Figure 1, Figure 2 , Figure 7 and Figure 8 In some specific embodiments, the stent body 110 has an inflow end 1102 and an outflow end 1103 arranged opposite to each other along its own axial direction and spaced apart. The inflow end 1102 is positioned toward the atrium, and the outflow end 1103 is positioned toward the ventricle. The anchoring rods 1201 in the aforementioned anchoring portions 1212 can be connected to the outflow end 1103 of the stent body 110, or to a region of the stent body 110 near the outflow end 1103.
[0085] One end of the anchoring part 1212 is connected to a connecting part 1211. The anchoring part 1212 is connected to the support body 110 through the connecting part 1211. The anchoring part 1212, the connecting part 1211, and the support body 110 can all be integrally connected, thereby making each anchoring segment 121 integrally connected to the support body 110, that is, the anchoring structure 120 is integrally connected to the support body 110. This integral connection can be integrally formed. This configuration, on the one hand, eliminates the connection interface between each anchoring segment 121 and the support body 110, improving the long-term stability and fatigue resistance of the anchoring structure 120 within the body; on the other hand, eliminating the need for additional connecting structures helps reduce the compression profile of the anchoring support 100, making the release process smoother and the release operation more controllable.
[0086] In some specific embodiments, the connecting part 1211 includes a connecting rod 1203. Each anchor rod 1201 may have a connecting rod 1203 extending axially along the support body 110 at its end. The connecting rod 1203 is used to connect with the support body 110. The connecting rod 1203 and the support body 110 are provided with a gap along the radial direction of the support body 110 to avoid affecting the expansion of the support body 110 due to their close proximity, and to avoid damage to the original atrioventricular valve leaflets due to excessive force caused by the close proximity of the anchoring structure 120 and the support body 110.
[0087] When the anchoring part 1212 includes two anchoring rods 1201 arranged axially at intervals along the support body 110, the two anchoring rods 1201 are respectively the first anchoring rod and the second anchoring rod. The first anchoring rod is closer to the inflow end 1102, and the second anchoring rod is closer to the outflow end 1103. Then, the length of the connecting rod 1203 corresponding to the first anchoring rod is greater than the length of the connecting rod 1203 corresponding to the second anchoring rod. Of course, the connecting rod 1203 can also be provided in the middle of the anchoring rod 1201, as long as it can meet the connection between each anchoring rod 1201 and the support body 110. This is only an example for illustration.
[0088] The connecting rod 1203 can be arranged in a U-shape, that is, it includes two vertical sides extending along the axial direction of the support body 110 and a horizontal side connecting the two vertical sides. One vertical side is connected to the support body 110, and the other vertical side is connected to the anchor rod 1201.
[0089] Alternatively, the connecting part 1211 can also be a sheet-like structure composed of multiple X-shaped connections, which is only an example here.
[0090] In actual use, the outlet end 1103 of the support body 110 is also provided with a fixing frame 111, which is used to fix the artificial leaflet, for example, for installing a temporary leaflet.
[0091] Please see Figure 1 and Figure 2 In some embodiments, any two adjacent anchoring segments 121 are spaced apart along the circumference of the stent body 110, that is, after each anchoring segment 121 is released, any two adjacent anchoring segments 121 are spaced apart. This arrangement can reduce the size of each anchoring segment 121 along the circumference of the stent body 110, further reducing interference when each anchoring segment 121 is released, and making it more convenient for each anchoring segment 121 to cross the chordae tendineae 2000. At this time, the arc length of the anchoring rod 1201 in each anchoring segment 121 along the circumference of the stent body 110 is small, and the cross-section is large, so as to ensure that it has high structural stability. In this embodiment, after each anchoring segment 121 is released, it can expand synchronously with the outward expansion of the stent body 110 along the radial direction of the stent body 110, so as to cooperate with the stent body 110 to clamp the original atrioventricular valve leaflets.
[0092] When multiple anchoring segments 121 are released simultaneously and in the same direction, any two adjacent anchoring segments 121 may have an overlapping area along the circumference of the support body 110 for a certain period of time. After the support body 110 expands, the anchoring segments 121 remain spaced apart along the circumference of the support body 110. This is just an example.
[0093] In some specific embodiments, each anchoring segment 121 includes a connecting portion 1211 and an anchoring portion 1212. The connecting portion 1211 may be located at one end of the anchoring portion 1212, for example, at the tail end of the anchoring portion 1212.
[0094] In summary, the anchoring stent 100 provided in this embodiment adopts a double-layered catheter release molding method with sequential and segmented release. When the anchoring structure 120 is released, each anchoring segment 121 expands circumferentially to pass through the chordae tendineae, providing a larger crossing range. Before the stent body 110 completes self-expansion, multiple anchoring segments 121 cooperate circumferentially to clamp the original atrioventricular valve leaflets between the anchoring segments 121 and the outer wall of the stent body 110. Furthermore, after the stent body 110 self-expands, it exerts an outward squeezing force on the anchoring structure 120, thereby increasing the clamping force on the original atrioventricular valve leaflets through the cooperation of the stent body 110 and each anchoring segment 121.
[0095] Please see Figures 9 to 11 In some embodiments, any two adjacent anchoring segments 121 can be locked along the circumference of the support body 110. That is, when multiple anchoring segments 121 are released simultaneously and in the same direction, any two adjacent anchoring segments 121 have an overlapping area along the circumference of the support body 110, and then overlap sequentially along the circumference to form a closed loop; then, after the support body 110 is released and expands outward, any two adjacent anchoring segments 121 gradually expand tangentially and lock, thereby achieving anchoring by the joint action of the anchoring structure 120 and the support body 110 to clamp the original atrioventricular valve leaflets. In other words, by overlapping and locking any two adjacent anchoring segments 121 along the circumference of the support body 110 after the anchoring segments 121 are released, continuous force is formed on the circumference of the original atrioventricular valve leaflets, which not only improves the structural strength of the anchoring structure 120 itself, but also improves the anchoring strength.
[0096] In summary, after the anchoring stent 100 provided in this embodiment is released layer by layer and segment by segment through the aforementioned double-layer catheter, before the stent body 110 completes self-expansion, multiple anchoring segments 121 can be slidably overlapped in the circumferential direction to clamp the original atrioventricular valve leaflets between the anchoring segments 121 and the outer wall of the stent body 110. After the stent body 110 self-expands, each anchoring segment 121 gradually expands tangentially and forms a closure. At the same time, during subsequent artificial valve expansion, each anchoring segment 121 can further pull and lock against each other to anchor the original atrioventricular valve leaflets.
[0097] In this configuration, any two adjacent anchoring segments 121 may have an overlapping area along the circumference of the support body 110 after the support body 110 expands, and lock together within this overlapping area. Alternatively, any two adjacent anchoring segments 121 may be precisely aligned end-to-end along the circumference of the support body 110 after the support body 110 expands to lock together. The connection of two anchoring segments 121 can be achieved through snap-fit, overlap, or plug-in joints, as long as it satisfies the connection requirement for any two adjacent anchoring segments 121. This is merely an example.
[0098] Please continue reading. Figures 9 to 11In some embodiments, each anchoring segment 121 further includes a locking part 1213 and a mating part 1214. Along the circumference of the support body 110, each anchoring segment 1212 has a locking part 1213 at one end and a mating part 1214 at the other end. Along the circumference of the support body 110, in any two adjacent anchoring segments 121, the mating part 1214 of one anchoring segment 121 and the locking part 1213 of the other anchoring segment 121 are locked together.
[0099] like Figure 9 and Figure 10 As shown, the locking part 1213 can be provided at the first end of the anchoring part 1212 along the circumference of the bracket body 110, and the mating part 1214 is provided at the last end of the anchoring part 1212 along the circumference of the bracket body 110. Of course, the mating part 1214 can also be provided in the area near the last end of the anchoring part 1212, and the locking part 1213 is provided in the area near the first end of the anchoring part 1212. Taking three anchoring sections 121 as an example, the three anchoring sections 121 are arranged as first anchoring section 121a, second anchoring section 121b and third anchoring section 121c. The first anchoring section 121a, the second anchoring section 121b and the third anchoring section 121c are all released independently from the head end to the tail end and form a ring. The locking part 1213 of the first anchoring section 121a overlaps with the anchoring part 1212 of the second anchoring section 121b. The locking part 1213 of the second anchoring section 121b overlaps with the anchoring part 1212 of the third anchoring section 121c. The locking part 1213 of the third anchoring section 121c overlaps with the anchoring part 1212 of the first anchoring section 121a. Subsequently, during the expansion of the stent body 110, the locking part 1213 of the first anchoring section 121a locks with the mating part 1214 of the second anchoring section 121b, the locking part 1213 of the second anchoring section 121b locks with the mating part 1214 of the third anchoring section 121c, and the locking part 1213 of the third anchoring section 121c locks with the mating part 1214 of the first anchoring section 121a. Through the layered release of the stent body 110 and the anchoring structure 120, the stent body 110 and the anchoring structure 120 are aligned during the shaping process, which improves the docking stability of the ring-forming process, avoids the positioning problems of multi-segment ring-forming methods, and also facilitates the anchoring of the original atrioventricular valve leaflets.
[0100] Furthermore, the anchoring section 121 also includes a connecting portion 1211 connected to the anchoring portion 1212. The connecting portion 1211 is connected to the support body 110, and at least a portion of the connecting portion 1211 can form a mating portion 1214. The connecting portion 1211 is formed via the aforementioned connecting rod 1203. When the anchoring portion 1212 includes multiple anchoring rods 1201, the connecting portion 1211 can include multiple connecting rods 1203, and the multiple connecting rods 1203 and the multiple anchoring rods 1201 correspond one-to-one and are connected, and can be integrally formed; the connecting portion 1211 can also include a single connecting rod 1203, through which multiple anchoring rods 1201 can be connected to the support body 110; this is only an example.
[0101] For example, when the anchoring part 1212 includes two anchoring rods 1201 spaced apart along the axial direction of the support body 110, the connecting part 1211 includes two connecting rods 1203 spaced apart circumferentially along the support body 110, with each connecting rod 1203 corresponding to one of the two anchoring rods 1201. Each connecting rod 1203 is U-shaped. Specifically, the connecting rod 1203 includes two vertical sides extending along the axial direction of the support body 110 and a horizontal side connecting the two vertical sides and extending radially along the support body 110. The locking part 1213 can be locked to one of the vertical sides of the connecting rod 1203 that is away from the support body 110, at which time the vertical side of the connecting rod 1203 forms a mating part 1214. Of course, the locking part 1213 can also be locked to both connecting rods 1203, as long as a locking mechanism can be formed; this is only an example. Therefore, when each anchoring segment 121 is connected by the aforementioned end-to-end connection to form a lock, the connecting force along the circumference of the support body 110 can be evenly distributed to each anchoring segment 121, which is beneficial for the anchoring structure 120 to cooperate with the support body 110 to anchor to the original atrioventricular valve leaflet and improve the stability of each anchoring segment 121 after ring formation; and, precisely because at least part of the connecting part 1211 serves as the mating part 1214 at this time, it is equivalent to setting the locking position of any two adjacent anchoring segments 121 at the connection between the anchoring segment 121 and the support body 110, thereby improving the structural strength and stability of the locking position of any two adjacent anchoring segments 121.
[0102] In this embodiment, each anchor rod 1201 can be made of a relatively long alloy wire with a small cross-section. Therefore, the stability of the anchor structure 120 after forming a ring can be improved by the above-described connection method. Of course, it is not limited to alloy wires with a relatively long length and a small cross-section; this is just an example.
[0103] Furthermore, the locking part 1213 and the mating part 1214 are configured to be detachably locked to each other, such as by snap-fit or plug-in. Of course, the locking of the locking part 1213 and the mating part 1214 is not limited to this method; it is sufficient as long as they can be detachably locked to each other. Furthermore, the mating part 1214 is configured to bidirectionally limit the locking part 1213 along the axial direction of the bracket body 110, thereby improving the axial stability when any two adjacent anchoring sections 121 are locked and reducing the risk of displacement. Specifically, as shown... Figure 9 As shown, the connecting rod 1203 is U-shaped. One of the connecting rods 1203 of the connecting part 1211 forms a mating part 1214 away from the vertical side of the bracket body 110. The anchoring rod 1201 connected to the connecting rod 1203 serves as a locking part 1213 that limits the movement of the bracket body 110 axially toward the inflow end 1102. The horizontal side of the connecting rod 1203 also serves as a locking part 1213 that limits the movement of the bracket body 110 axially toward the outflow end 1103.
[0104] like Figure 9 and Figure 10 As shown, in some embodiments, the locking part 1213 is angled to the anchoring part 1212. Furthermore, the locking part 1213 can extend from the anchoring part 1212 toward the side closer to the bracket body 110, i.e., the locking part 1213 is hook-shaped relative to the anchoring part 1212 to form a claw. After the multiple anchoring segments 121 are released simultaneously and in the same direction, each anchoring segment 121 rotates into a ring, and any two adjacent anchoring segments 121 have an overlapping area along the circumference of the bracket body 110. The locking part 1213 of the latter anchoring segment 121 is located in the gap of the former anchoring segment 121, and then expands outward together with the expansion of the bracket body 110, causing the locking part 1213 to hook onto the corresponding mating part 1214 and lock.
[0105] It should be noted that the gap of the anchoring section 121 mentioned above refers to the gap between any two adjacent anchoring rods 1201 in the corresponding anchoring part 1212.
[0106] In practical use, the end of the anchor rod 1201 in the anchoring part 1212 that is away from the connecting rod 1203 can form a locking part 1213. Taking the anchoring part 1212 as an example that includes two anchor rods 1201, the two anchor rods 1201 extend at the end away from the corresponding connecting rod 1203 and are connected to each other to form the locking part 1213.
[0107] The angle between the locking part 1213 and the anchoring part 1212 can be 100°-170°. Understandably, if the bending angle of the locking part 1213 relative to the anchoring part 1212 is too small, it will cause the locking part 1213 of the subsequent anchoring segment 121 to abut against the connecting part 1211 of the previous anchoring segment 121 when the anchoring segment 121 is released, resulting in deformation of the subsequent anchoring segment 121 or obstruction of release. It may also prevent the anchoring segment 121 from smoothly passing through the tendineae 2000. Conversely, if the bending angle of the locking part 1213 relative to the anchoring part 1212 is too large, it will cause slippage when the subsequent anchoring segment 121 connects to the connecting part 1211 of the previous anchoring segment 121 via the locking part 1213, leading to unstable connection and affecting anchoring strength. Therefore, the bending angle of the locking part 1213 relative to the anchoring part 1212 is limited so that, while ensuring a reliable connection with the connecting part 1211, it can not only better pass over the connecting part 1211 to make a limiting connection with the connecting part 1211, but also smoothly pass through the tendon cable 2000.
[0108] In some specific embodiments, the included angle between the locking part 1213 and the anchoring part 1212 is any value between 100° and 170°, such as 100°, 106°, 110°, 115°, 120°, 122°, 128°, 130°, 134°, 140°, 146°, 150°, 153°, 157°, 160°, 164°, 168°, and 170°.
[0109] Furthermore, the locking part 1213 and the anchoring part 1212 are rounded at the corners, with a radius of curvature of 1mm-3mm. Understandably, this rounded transition prevents stress concentration at the bend from causing the anchoring structure 120 to break. Simultaneously, by limiting the radius of curvature of the rounded corners, it ensures that the connection between the locking part 1213 and the anchoring part 1212 does not occupy excessive radial space, and also facilitates smoother passage of the anchoring section 121 through the tendon cable 2000 at its initial end. If the radius of curvature of the rounded corner is too large, it will result in excessive space occupation and potential interference; conversely, if the radius of curvature of the rounded corner is too small, it will easily cause stress concentration and localized cracking.
[0110] In some specific embodiments, the radius of curvature of the fillet is any value between 1mm and 3mm, such as 1mm, 1.25mm, 1.33mm, 1.78mm, 2mm, 2.35mm, 2.5mm, 2.75mm, 2.89mm, 3mm.
[0111] Please see Figure 11 and Figure 12In some other embodiments, the locking part 1213 is located at the tail end of the anchoring part 1212, and the mating part 1214 is located at the head end of the anchoring part 1212. The locking part 1213 includes a hook at one end of the anchoring part 1212, for example, the hook may be bent outward from the anchoring part 1212. In this case, the mating part 1214 may be an arc shape adapted to the arc length direction of the anchoring part 1212, or it may be bent inward from the anchoring part 1212. When the anchoring structure 120 expands outward together with the bracket body 110, the mating part 1214 hooks the hook and locks it. The claw includes a claw body 1213a and a fixing arm 1213b connected to the claw body 1213a. The fixing arm 1213b is fixed to the anchoring part 1212. The claw body 1213a bends from the end of the fixing arm 1213b away from the anchoring part 1212, towards the side away from the support body 110. The fixing arm 1213b ensures a stable connection between the claw and the anchoring part 1212. The fixing arm 1213b is located in the gap of the anchoring part 1212, and the claw body 1213a extends outward from the gap for locking with the locking part 1213. The claw is U-shaped.
[0112] The angle between the fixed arm 1213b and the claw body 1213a can be greater than 90°, equal to 90°, or even any value between 100° and 170° as mentioned above. The short and long sides of the L-shape are rounded, and the radius of curvature of the rounded corners can be any value between 1mm and 3mm; this is just an example.
[0113] Furthermore, relative to the anchoring portion 1212, the fixing arm 1213b is positioned closer to the support body 110, so that the radial dimension of the fixing arm 1213b near the claw body 1213a along the support body 110 is smaller. Even further, the distance between the fixing arm 1213b near the claw body 1213a and the support body 110 is smaller than the distance between the anchoring portion 1212 and the support body 110. In other words, the fixing arm 1213b is positioned closer to the support body 110 than the anchoring portion 1212, ensuring that in its natural state, the fixing arm 1213b and the claw body 1213a do not protrude or protrude excessively relative to the anchoring portion 1212 along the radial direction of the support body 110, thereby reducing release interference.
[0114] In some specific embodiments, the locking part 1213 is connected to the end of the anchoring part 1212 facing the connecting part 1211, and the corresponding anchoring part 1212 and connecting part 1211 do not protrude in the radial direction of the bracket body 110, so as to reduce the risk of interference with the tendon cord and also reduce the space occupied by the anchoring section 121 in the radial direction.
[0115] Please continue reading. Figure 11 and Figure 12Furthermore, the anchoring section 121 also includes a traction section 1215 connected to the locking section 1213. The traction section 1215 is configured to release later than the locking section 1213 and the anchoring section 1212 to drive the locking section 1213 to move toward the side closer to the support body 110, which facilitates the corresponding mating section 1214 to pass over the connecting section 1211 and the anchoring section 1212 and lock. Of course, it can also only pass over the connecting section 1211 and lock. That is to say, the setting of the traction section 1215 can cause the locking section 1213 to have a tendency to move toward the side of the support body 110 during the release of the anchoring section 121, which makes it easier for the first end of the subsequent anchoring section 121 to pass over the tendineae 2000 more smoothly and lock through the locking section 1213 of the previous anchoring section 121 and the mating section 1214 of the subsequent anchoring section 121. When the first end of the next anchoring segment 121 passes over the tendon cable 2000 so that the corresponding anchoring part 1212 and mating part 1214 are located on the outer periphery of the tendon cable 2000 and the outer periphery of the locking part 1213 of the previous anchoring segment 121, the traction part 1215 can release the pulling force on the locking part 1213, causing the locking part 1213 to move toward the side away from the support body 110 to hook the mating part 1214 to achieve locking.
[0116] When the anchoring structure 120 is released, the mating part 1214, the anchoring part 1212, and the locking part 1213 of the previous anchoring section 121 can be gradually released first. The corresponding traction part 1215 remains in the outer conduit 320, thereby generating a pulling force on the locking part 1213 towards the side of the stent body 110, so that the locking part 1213 is pulled inward to avoid the locking part 1213 hooking onto the chordae tendineae below the native atrioventricular valve leaflet when the anchoring structure 120 is released. After the anchoring stent 100 is adjusted to the position of clamping the native atrioventricular valve leaflet, the traction part 1215 is released, and the locking part 1213 can be inserted into the gap of the mating part 1214 of the previous anchoring section 121 and overlapped, locking with the mating part 1214 when the stent body 110 expands outward in the future.
[0117] Please see Figure 13 and Figure 14 In some embodiments, the anchoring stent 100 further includes an outer skirt 130, which is connected to the stent body 110 and covers the inner and outer walls of the stent body 110. The anchoring stent 100 also includes a flange structure 150, which consists of two alternating rings of nickel-titanium wire corrugated rings near the atrium. The flange structure conforms to the original atrioventricular valve annulus and can deform with cardiac contraction and relaxation, without a rigid connection to the stent body 110. The anchoring stent 100 also includes a connecting skirt 140, which can be sutured to the outer skirt 130. The connecting skirt 140 flexibly connects the flange structure 150 to the stent body 110, preventing hemodynamic instability due to deformation of the stent body 110.
[0118] The flange structure 150 can work in conjunction with the anchoring structure 120 to form a bidirectional axial positioning of the support body 110, thereby improving the installation stability of the anchoring support 100. To cover the original atrioventricular valve orifice, the outer edge width of the flange structure 150 is approximately 38mm-50mm, such as any value between 38mm, 40mm, 42mm, 45.6mm, 48.33mm, 49.86mm, and 50mm.
[0119] Furthermore, the anchoring stent 100 may also include a temporary leaflet 160 disposed inside the stent body 110, temporarily assuming the function of controlling unidirectional blood flow by the atrioventricular valve; the temporary leaflet 160 may be made of polymer materials such as polyethylene terephthalate, bovine pericardial tissue, polytetrafluoroethylene, and polyurethane, and the thickness of the temporary leaflet 160 is 0.03mm-0.1mm, such as 0.03mm, 0.05mm, 0.077mm, 0.089mm, 0.1mm, etc., any value between 0.03mm and 0.1mm.
[0120] Please see Figures 15 to 18 This application also provides an artificial valve device 1000, including an artificial valve 200 and the aforementioned anchoring stent 100. The anchoring stent 100 may have a stent body 110 with a channel 1101, and at least a portion of the artificial valve 200 is disposed within the channel 1101. Specifically, after the artificial valve device 1000 is implanted, the artificial valve 200 is pressed against the stent body 110. The aforementioned artificial valve 200 can be... Figures 15 to 18 The structure, or other common support structure, skirt arrangement and leaflet configuration in this field, this application does not impose any special limitations on artificial valves.
[0121] For example, the artificial valve 200 includes an inner stent 230 and artificial leaflets 220 fixed inside the inner stent 230. The artificial valve 200 also includes an inner skirt 210, which covers the outer and inner peripheral surfaces of the inner stent 230. Multiple artificial leaflets 220 are sutured to the inner side of the inner skirt 210, and a closed suture ring is formed on the outer side of the inner skirt 210. When the artificial valve 200 is inserted, the suture ring fits more closely to the anchoring stent 100 on the outer peripheral side. The inner stent 230 is generally cylindrical and has a ventricular end hole. The wall of the ventricular end hole is bonded to or sutured to the artificial leaflets 220, and the multiple artificial leaflets 220 are symmetrically connected. Artificial leaflet 220 can be made of bovine pericardium material with a thickness of 0.2mm-0.5mm, such as any value between 0.2mm, 0.22mm, 0.25mm, 0.278mm, 0.3mm, 0.33mm, 0.375mm, 0.4mm, 0.415mm, 0.445mm, 0.48mm, and 0.5mm.
[0122] During the implantation of the artificial valve device 1000, the anchoring stent 100 is first implanted through a catheter. After the anchoring stent 100 is anchored and stabilized by the anchoring structure 120, the artificial valve 200 is then implanted through the channel 1101 of the anchoring stent 100 via a catheter, and its axial relative position is finely adjusted to ensure that the artificial valve 200 is in a relatively centered position within the anchoring stent 100, and then released. The artificial valve 200 expands through balloon inflation and compresses the stent body 110, thereby causing the inner skirt 210 and the outer skirt 130 to fit tightly together to form a seal. Furthermore, when the artificial valve 200 compresses the stent body 110, it can cooperate with the anchoring structure 120 to press the original atrioventricular valve leaflets together tightly, further reducing paravalvular leakage.
[0123] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0124] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.
Claims
1. An anchoring bracket, characterized in that, The system includes a support body (110) and an anchoring structure (120). The anchoring structure (120) includes a plurality of anchoring segments (121) arranged circumferentially around the support body (110) so that the anchoring structure (120) surrounds the outer periphery of the support body (110). Each anchoring segment (121) is connected to the support body (110). Each of the anchoring segments (121) includes an anchoring portion (1212) extending circumferentially along the support body (110), the anchoring portion (1212) being connected to the support body (110), the anchoring portion (1212) including a plurality of anchoring rods (1201) arranged axially spaced along the support body (110), at least a portion of the anchoring rods (1201) being connected to the support body (110).
2. The anchoring bracket according to claim 1, characterized in that, The anchoring part (1212) also includes a reinforcing rod (1202) connected between any two adjacent anchoring rods (1201) along the axial direction of the support body (110).
3. The anchoring bracket according to claim 1, characterized in that, The support body (110) and the anchoring structure (120) can be released in layers.
4. The anchoring bracket according to claim 1 or 3, characterized in that, Each of the anchoring sections (121) is integrally connected to the support body (110).
5. The anchoring bracket according to claim 1, characterized in that, Each of the anchoring sections (121) further includes a locking part (1213) and a mating part (1214). Along the circumference of the support body (110), each of the anchoring sections (1212) has the locking part (1213) at one end and the mating part (1214) at the other end. Along the circumference of the support body (110), in any two adjacent anchoring sections (121), the mating part (1214) of one anchoring section (121) and the locking part (1213) of the other anchoring section (121) are locked together.
6. The anchoring bracket according to claim 5, characterized in that, At least a portion of the locking part (1213) is angled relative to the anchoring part (1212); and / or, The locking part (1213) includes a hook provided at one end of the anchoring part (1212).
7. The anchoring bracket according to claim 5, characterized in that, The anchoring section (121) further includes a connecting part (1211) connected to the anchoring part (1212), and the connecting part (1211) is connected to the support body (110).
8. The anchoring bracket according to claim 7, characterized in that, At least a portion of the connecting portion (1211) forms the mating portion (1214).
9. The anchoring bracket according to claim 6, characterized in that, The anchoring section (121) also includes a traction section (1215) connected to the locking section (1213), the traction section (1215) being configured to release later than the locking section (1213) and the anchoring section (1212) to drive the locking section (1213) to move toward the side closer to the support body (110).
10. An artificial valve device, characterized in that, The device includes an artificial valve (200) and an anchoring stent (100) according to any one of claims 1 to 9, wherein the stent body (110) of the anchoring stent (100) is provided with a channel (1101), and at least a portion of the artificial valve (200) is disposed within the channel (1101).