A transcatheter valve replacement device and its stent

Abstract

The present invention provides a transcatheter valve replacement device and its stent, relating to the technical field of cardiac valves. The transcatheter valve replacement stent includes a stent body and a clamping mechanism. Among them, the stent body is a cylindrically shaped frame structure that can be radially compressed and expanded; the clamping mechanism is disposed around the outer periphery of the stent body, and the clamping mechanism includes a skirt support structure and an anchoring structure respectively connected to the stent body. The skirt support structure and the anchoring structure cooperate to be suitable for clamping the autologous leaflets. The present invention can solve the problem of artificial valve displacement in the prior art. By the cooperation of the anchoring structure and the skirt support structure, the autologous leaflets are clamped, and the clamping is stable, which can ensure that the artificial valve does not displace, and avoid the occurrence of paravalvular leakage or the induction of other complications.

Description

Technical Field

[0001] The present invention relates to the technical field of heart valves, and particularly relates to a transcatheter valve replacement device and its stent. Background Art

[0002] Transcatheter mitral valve replacement (TMVR) does not require thoracotomy, cardiac arrest, or extracorporeal circulation, greatly reducing the surgical trauma and becoming another research hotspot after transcatheter aortic valve replacement (TAVR). Most of the existing transcatheter mitral valve replacement systems rely on radial support force to anchor or clamp the artificial valve. Radial support force anchoring is prone to insufficient anchoring force, resulting in displacement of the artificial valve, which may lead to paravalvular leakage or other complications. Therefore, there is a need to provide a transcatheter valve replacement device that can be stably anchored. Summary of the Invention

[0003] Therefore, the technical problem to be solved by the present invention is to overcome the defect of artificial valve displacement in the prior art, so as to provide a transcatheter valve replacement device and its stent.

[0004] To solve the above problems, on the one hand, the present invention provides a transcatheter valve replacement stent, including a stent body and a clamping mechanism. The stent body is a cylindrically-shaped frame structure that can be radially compressed and expanded, having a crimped state and an expanded state; the clamping mechanism is disposed around the outer periphery of the stent body, and the clamping mechanism includes a skirt structure and an anchoring structure respectively connected to the stent body. When the stent body is in the expanded state, the skirt structure and the anchoring structure cooperate to be suitable for clamping the autologous leaflets.

[0005] Optionally, the skirt structure is disposed at the first end of the stent body; the skirt structure surrounds the stent body in a circle and extends towards the outside of the stent body.

[0006] Optionally, the skirt structure includes a first skirt segment connected to the stent body and a second skirt segment connected to the first skirt segment. The first skirt segment is bent outward, and the second skirt segment is bent inward.

[0007] Optionally, the anchoring structure includes a plurality of anchoring members spaced around the outer periphery of the stent body, and the anchoring members cooperate with the skirt structure to clamp the autologous leaflets.

[0008] Optionally, the anchoring member includes an anchoring rod. The first end of the anchoring rod is connected to the stent body, and the second end of the anchoring rod extends towards the skirt structure and cooperates with the skirt structure to clamp the autologous leaflets.

[0009] Optionally, a protective structure is provided at the second end of the anchoring rod.

[0010] Optionally, the protective structure includes an extension block protruding from the anchoring rod, and the outer contour of the extension block is a smooth curve.

[0011] Optionally, the second end of the anchoring rod is bent towards one side to form a protective structure.

[0012] Optionally, the second end of the anchoring rod is bent close to the stent body; or, the second end of the anchoring rod is bent away from the stent body.

[0013] Optionally, the arc formed by bending the second end of the anchoring rod is a major arc to adapt to the posterior cusp of the mitral valve; or, the arc formed by bending the second end of the anchoring rod is a minor arc to adapt to the anterior cusp of the mitral valve.

[0014] Optionally, the multiple anchoring members are divided into a first clamping group and a second clamping group. The second end of the anchoring rod of the first clamping group is bent close to the stent body, and the second end of the anchoring rod of the second clamping group is bent away from the stent body.

[0015] Optionally, a strengthening structure is connected between two adjacent anchoring rods.

[0016] Optionally, the strengthening structure includes a strengthening rod. The strengthening rod is one or a combination of a V-shaped, U-shaped, and W-shaped rod, and both ends of the strengthening rod are respectively connected to two adjacent anchoring members.

[0017] Optionally, the first end of the anchoring rod is connected to the second end of the stent body. In the crimped state, the anchoring rod does not overlap with the stent body in the radial direction of the stent body.

[0018] Optionally, the first end of the stent body is provided with a delivery connection structure. The delivery connection structure includes a plurality of connecting rods arranged around the stent body. One end of the connecting rod is connected to the first end of the stent body, and the other end of the connecting rod extends axially away from the first end of the stent body and is provided with a hanging portion at the end. The hanging portion is adapted to be connected to a delivery system.

[0019] Optionally, the stent body is provided with a plurality of leaflet suture ears around the stent body.

[0020] On the other hand, the present invention provides a transcatheter valve replacement device, including the transcatheter valve replacement stent according to any one of the above technical solutions.

[0021] Optionally, a sealing skirt is connected to the skirt support structure. The sealing skirt is disposed closely on the inner side of the stent body around the stent body. The first end of the sealing skirt is connected to the skirt support structure, and the second end of the sealing skirt extends towards the second end of the stent body.

[0022] Optionally, the transcatheter valve replacement stent further includes leaflet suture ears, and the second end of the sealing skirt partially or completely covers the leaflet suture ears.

[0023] Optionally, the transcatheter replacement valve stent further includes leaflet suture ears, and an artificial valve is sutured and connected at the position of the leaflet suture ears on the inner side of the stent body; there are two artificial valves, which are suitable for replacing the mitral valve of the patient; or, there are three artificial valves, which are suitable for replacing the aortic valve of the patient; in some special medical conditions, four artificial valves can also be provided.

[0024] The present invention has the following advantages:

[0025] 1. Using the technical solution of the present invention, compared with the existing technical solution that relies on radial support force for anchoring, the present invention can cooperate with the anchoring structure and the skirt support structure to clamp the autologous leaflets, with stable clamping, which can ensure that the artificial valve does not shift, avoid paravalvular leakage or cause other complications. In addition, because the skirt support structure is located on the atrial side of the autologous leaflets, it can clamp the roots of the autologous leaflets, with better clamping effect, making the transcatheter replacement valve more stable after release.

[0026] 2. The skirt support structure expands towards the outside of the stent body, which can expand the clamping area of the skirt support structure and the anchoring structure on the autologous leaflets, making the artificial valve more stably anchored.

[0027] 3. A protective structure is arranged at the second end of the anchoring rod, which can prevent the end of the anchoring rod from piercing the myocardial tissue or the autologous leaflets, and causing unnecessary damage to the patient.

[0028] 4. The multiple anchoring members are divided into a first clamping group and a second clamping group. The bending direction of the second end of the anchoring rod in the first clamping group is opposite to the bending direction of the second end of the anchoring rod in the second clamping group. In addition, the arc formed by the bending of the second end of the anchoring rod in the first clamping group is a major arc, and the arc formed by the bending of the second end of the anchoring rod in the second clamping group is a minor arc. The first clamping group and the second clamping group are differentially arranged, which can respectively adapt to the anterior cusp and the posterior cusp of the mitral valve, making the transcatheter replacement valve stent more adaptable to the physiological characteristics of the mitral valve while ensuring that it does not pierce the myocardial tissue or the autologous leaflets.

[0029] 5. A strengthening structure is connected between two adjacent anchoring rods. The strengthening structure can improve the strength and stability of the anchoring rods, effectively prevent the deviation of the anchoring rods, avoid the displacement of the transcatheter replacement valve and affect the coaxiality with the autologous valve annulus, and avoid paravalvular leakage.

[0030] 6. In the crimped state, the anchoring rod can be folded to extend along the axial direction of the stent body, so that the transcatheter replacement valve stent has only a single layer, which can effectively reduce the delivery size of the transcatheter replacement valve stent and ensure a smoother delivery process. Description of the Drawings

[0031] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0032] Figure 1 Fig. shows a schematic structural diagram of a transcatheter replacement valve stent provided in Embodiment 1 of the present invention;

[0033] Figure 2 Fig. shows a front view of a transcatheter replacement valve stent provided in Embodiment 1 of the present invention;

[0034] Figure 3 Fig. shows a top view of a transcatheter replacement valve stent provided in Embodiment 1 of the present invention;

[0035] Figure 4 Fig. shows an axial sectional view of a transcatheter replacement valve stent provided in Embodiment 1 of the present invention;

[0036] Figure 5 Fig. shows a schematic structural diagram of a transcatheter replacement valve stent with the anchoring structure removed;

[0037] Figure 6 Fig. shows Figure 5 front view of

[0038] Figure 7 Fig. shows a schematic structural diagram of the anchoring rods of the first clamping group and the second clamping group provided in Embodiment 1 of the present invention;

[0039] Figure 8 Fig. shows a schematic structural diagram of the transcatheter replacement valve stent clamping the autologous valve leaf after release provided in Embodiment 1 of the present invention;

[0040] Figure 9 Fig. shows a schematic structural diagram of a transcatheter replacement valve stent provided in Embodiment 2 of the present invention;

[0041] Figure 10 Fig. shows Figure 9 front view of

[0042] Figure 11 Fig. shows a schematic structural diagram of a transcatheter replacement valve stent provided in Embodiment 3 of the present invention;

[0043] Figure 12 Fig. shows Figure 11 front view of

[0044] Figure 13Shows a schematic structural diagram of a transcatheter replacement valve stent provided in Embodiment 4 of the present invention;

[0045] Figure 14 Shows Figure 13 An axial sectional view in;

[0046] Figure 15 Shows Figure 13 A schematic structural diagram of the anchoring structure in;

[0047] Figure 16 Shows a schematic structural diagram of a transcatheter replacement valve stent provided in Embodiment 5 of the present invention;

[0048] Figure 17 Shows Figure 16 A schematic structural diagram of the anchoring structure in;

[0049] Figure 18 Shows a schematic structural diagram of a sealing skirt in a transcatheter replacement valve provided in an embodiment of the present invention;

[0050] Figure 19 Shows a schematic structural diagram of the anchoring structure in the crimped state and the deployed state;

[0051] Figure 20 Shows another schematic structural diagram of a sealing skirt in a transcatheter replacement valve provided in an embodiment of the present invention;

[0052] Figure 21 Shows Figure 20 A schematic structural diagram of the sutured state of the sealing skirt and the stent body in;

[0053] Explanation of reference numerals:

[0054] 1. Stent body; 2. Skirt support structure; 21. First skirt support section; 22. Second skirt support section; 3. Anchoring structure; 30. Anchor; 300. Anchor rod; 31. First clamping group; 32. Second clamping group; 4. Autologous valve leaf; 41. Posterior cusp; 42. Anterior cusp; 5. Protection structure; 51. Expansion block; 6. Reinforcement structure; 61. Reinforcement rod; 7. Delivery connection structure; 71. Connecting rod; 72. Hanging portion; 8. Valve leaf suture ear; 9. Sealing skirt; 91. Triangular extension section; 10. Artificial valve; 11. Left atrium; 12. Left ventricle; 13. Myocardial tissue; 14. Interatrial septum. Detailed implementation manners

[0055] The technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0056] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0057] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installation", "connection", "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0058] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0059] For the convenience of introducing the technical solution of the present invention, the following will be described in detail in conjunction with the accompanying drawings and specific embodiments, but the embodiments should not be regarded as a limitation of the present invention.

[0060] Embodiment 1

[0061] A transcatheter replacement valve stent is made of a nickel-titanium alloy material with shape memory function, which can be radially compressed, transported through a catheter, released after reaching the position, and can be radially self-expanded into a prefabricated shape. Refer to Figures 1 - 8 , the transcatheter replacement valve stent includes a stent body 1 and a clamping mechanism. Among them, the stent body 1 is a cylindrical frame structure that can be radially compressed and expanded, and reference can be made to Figure 5 and Figure 6 ; the stent body 1 has a crimped state and an expanded state, refer to Figure 19。The clamping mechanism is arranged around the outer periphery of the stent body 1. The clamping mechanism includes a skirt support structure 2 and an anchoring structure 3 respectively connected to the stent body 1. When the stent body 1 is in the deployed state, the skirt support structure 2 and the anchoring structure 3 cooperate to be adapted to clamp the autologous leaflet 4.

[0062] Using the technical solution of the present invention, compared with the existing technical solution that relies on radial supporting force for anchoring, the present invention can clamp the autologous leaflet 4 through the cooperation of the anchoring structure 3 and the skirt support structure 2, and the clamping is stable, which can ensure that the transcatheter replacement valve 10 does not shift, and avoid generating perivalvular leakage or causing other complications. In addition, because the skirt support structure 2 is located on the atrial side of the autologous leaflet 4 and can clamp the root of the autologous leaflet 4, the clamping effect is better, making the transcatheter replacement valve more stable after release.

[0063] The transcatheter replacement valve stent provided by the present invention is applicable to aortic valve or mitral valve replacement. Here, the mitral valve replacement stent is taken as an example to illustrate the technical solution of the present invention.

[0064] Further, referring to Figures 1 - 8 , the stent body 1 has a first end and a second end which are oppositely arranged. From the Figure 2 orientation, the first end of the stent body 1 is the upper end and also the inflow end; the second end of the stent body 1 is the lower end and also the outflow end. The skirt support structure 2 is arranged at the first end of the stent body 1. The skirt support structure 2 surrounds the stent body 1 for one week and extends towards the outside of the stent body 1. The outer diameter of the skirt support structure 2 is larger than the diameter of the stent body 1. After the transcatheter replacement valve stent is released, the skirt support structure 2 is located in the left atrium 11, that is, on the upper side of the patient's autologous leaflet 4. The skirt support structure 2 extending towards the outside of the stent body 1 can increase the clamping area of the skirt support structure 2 and the anchoring structure 3 on the autologous leaflet 4, making the artificial valve 10 more stable in anchoring.

[0065] Further, referring to Figures 1 - 8 , the skirt support structure 2 includes a first skirt support section 21 connected to the stent body 1 and a second skirt support section 22 connected to the first skirt support section 21. The first skirt support section 21 is bent outward, and the second skirt support section 22 is bent inward. As a preferred implementation manner, the first skirt support section 21 is smoothly connected to the stent body 1, and the first skirt support section 21 and the second skirt support section 22 are smoothly connected. It should be noted that the first skirt support section 21 being bent outward means that the first skirt support section 21 is bent towards the side away from the center of the stent body 1. Correspondingly, the second skirt support section 22 being bent inward means that the second skirt support section 22 is bent towards the side close to the stent body 1. Therefore, the first skirt support section 21 and the second skirt support section 22 are bent in opposite directions. The skirt support structure 2 can be vividly regarded as a disc-shaped mesh stent, such as Figure 1 , Figure 5 and Figure 6As shown, the skirt support structure 2 provides support for the stitching of the flexible sealing skirt cloth 9. The sealing skirt cloth 9 will be introduced later. Refer to Figure 4 , after the second skirt support section 22 is bent, it can fit the myocardial tissue 13 or the atrial septum 14, which can improve the sealing effect. There are grid openings between the first skirt support section 21 and the second skirt support section 22, or between the second skirt support section 22 and the stent body 1.

[0066] Furthermore, the anchoring structure 3 includes a plurality of anchor members 30 arranged at intervals around the outer periphery of the stent body 1. The anchor members 30 cooperate with the skirt support structure 2 to clamp the autologous valve leaf 4.

[0067] Furthermore, in this embodiment, refer to Figures 1 - 8 , the anchor member 30 includes an anchor rod 300. The first end of the anchor rod 300 is connected to the stent body 1, and the second end of the anchor rod 300 extends towards the skirt support structure 2 and cooperates with the skirt support structure 2 to clamp the autologous valve leaf 4 during ventricular contraction, preventing the transcatheter replacement valve from shifting and preventing paravalvular leakage.

[0068] From the Figure 2 orientation, the first end of the anchor rod 300 is the Figure 2 lower end in Figure 2 , and correspondingly, the second end of the anchor rod 300 is the Figure 8 upper end in . The skirt support structure 2 expands towards the outside of the stent body 1, and the anchor rod 300 is also arranged on the outside of the stent body 1. The skirt support structure 2 and the second end of the anchor rod 300 form a clamping mechanism. As mentioned above, refer to Figure 8 , after the transcatheter replacement valve stent is released, the skirt support structure 2 is located in the left atrium 11, that is, above the autologous valve leaf 4, and the anchor rod 300 is located in the left ventricle 12, that is, below the autologous valve leaf 4. The skirt support structure 2 and the anchor rod 300 clamp the autologous valve leaf 4 therein.

[0069] The skirt support structure 2 is an annular frame structure, and a plurality of anchor rods 30 are arranged at intervals around the stent body 1. Therefore, a plurality of clamping points are formed around the stent body 1 between the skirt support structure 2 and the anchor rod 300. As a preferred implementation manner, the anchor rods 30 are evenly arranged at intervals around the stent body 1, so that both the anterior cusp 42 and the posterior cusp 41 of the mitral valve can be subjected to uniform clamping force to ensure stable clamping. Refer to Figures 1 - 8, in this embodiment, 12 anchoring rods 300 are provided. Specifically, the second end of the anchoring rod 300 can extend to the grid opening of the skirt support structure 2. At least two skirt support rods at the grid opening of the skirt support structure 2 can clamp the autologous leaflet 4. Compared with the scheme in which the anchoring rod 300 cooperates with a single skirt support rod of the skirt support structure 2 to clamp the autologous leaflet 4, when the second end of the anchoring rod 300 extends to the grid opening of the skirt support structure 2, at least two skirt support rods cooperate with the anchoring rod 300 to clamp the autologous leaflet 4, with a large clamping area and more stable clamping. In addition, since the skirt support structure 2 is provided at the first end of the stent body 1, that is, Figure 2 the upper end in

[0070] and the second end of the anchoring rod 300 extends towards the skirt support structure 2, therefore, the skirt support structure 2 and the anchoring rod 300 can clamp the root of the autologous leaflet 4. Compared with the way of radially supporting and anchoring by relying on the anchoring rod 300, clamping the root of the autologous leaflet 4 in this embodiment can be more stable, ensuring that the transcatheter replacement valve is not prone to radial and axial displacement along the stent body 1.

[0071] Specifically, referring to Figures 1 - 8 , the protection structure 5 includes an extension block 51 protruding from the anchoring rod 300, and the outer contour of the extension block 51 is a smooth curve. In order to reduce the delivery size after the stent is compressed, as a preferred embodiment, referring to Figure 7 , the outer contour of the extension block 51 is circular, and the extension block 51 is in the shape of a flat round handle. The extension blocks 51 of the 12 anchoring rods 300 around the stent body 1 are all arranged facing the center side of the stent body 1. In this way, when the stent body 1 is deployed, the second end of the anchoring rod 300 will not pierce the myocardial tissue 13 or the autologous leaflet 4, and when the stent body 1 is compressed and held, the overall transcatheter replacement valve stent has a smaller delivery size.

[0072] The mitral valve has an anterior cusp 42 and a posterior cusp 41. Referring to Figure 8 , the anterior cusp 42 is close to the interatrial septum 14, the posterior cusp 41 is far from the interatrial septum 14, and the posterior cusp 41 is connected to the myocardial tissue 13. Therefore, the anchoring rods 300 near the anterior cusp 42 do not need to consider the problem of piercing the myocardial tissue 13, while the anchoring rods 300 in the posterior cusp 41 part need to consider the problems of piercing the myocardial tissue 13 and puncturing the autologous leaflet 4. In order to adapt to this physiological characteristic, as a preferred embodiment, the anchoring rods 300 in this embodiment are differentially arranged. Referring toFigures 1 - 8 In this embodiment, the 12 anchoring rods 300 evenly spaced around the stent body 1 are divided into two groups, namely the first clamping group 31 and the second clamping group 32. The first clamping group 31 is composed of 6 anchoring rods 300 close to the anterior leaflet 42, and the second clamping group 32 is composed of 6 anchoring rods 300 close to the posterior leaflet 41. The first clamping group 31 is used to clamp the anterior leaflet 42 of the mitral valve, and the second clamping group 32 is used to clamp the posterior leaflet 41 of the mitral valve. Since there is no need to consider the problem of puncturing the myocardial tissue 13 for the anterior leaflet 42, an expansion block 51 is provided at the second end of the anchoring rod 300 in the first clamping group 31, and the expansion block 51 is in the shape of a round handle. The second end of the anchoring rod 300 in the second clamping group 32 is bent toward the side of the stent body 1 to avoid puncturing the myocardial tissue 13 and the autologous leaflet 4. In order to reduce the overall weight of the transcatheter heart valve replacement stent, a weight-reducing hole can be opened in the middle of the expansion block 51.

[0073] Furthermore, a strengthening structure 6 is connected between two adjacent anchoring rods 300. The strengthening structure 6 can improve the strength of the anchoring rod 300 and the stability of anchoring, effectively prevent the anchoring rod 300 from shifting circumferentially along the stent body 1, avoid the displacement of the transcatheter heart valve replacement and affect the coaxiality with the autologous valve annulus, ensure the uniform distribution and lateral stability of each anchoring rod 300, so Figure 2 in terms of orientation, it can also be said to be horizontal stability, and avoid the displacement of the stent body 1 and the occurrence of paravalvular leakage.

[0074] Furthermore, the strengthening structure 6 includes a strengthening rod 61, and the strengthening rod 61 is a combination of one or more of V-shaped, U-shaped, and W-shaped. The two ends of the strengthening rod 61 are respectively connected to two adjacent anchoring members 30. In this embodiment, the strengthening rod 61 is V-shaped.

[0075] Furthermore, during the process of releasing the transcatheter heart valve replacement stent as a whole from the sheath tube, if the release position is not accurately positioned, it can be retrieved, that is, the transcatheter heart valve replacement stent as a whole is retrieved into the sheath tube, and after adjusting the position, it is released again. In order to ensure that the transcatheter heart valve replacement stent as a whole can be successfully retrieved, in the compressed state, the tip of the V-shaped strengthening rod 61 faces the same direction as the release direction of the transcatheter heart valve replacement stent. During the release process, the second end of the stent body 1 is released before the first end, that is, Figure 2 the lower end of the stent body 1 in the middle is released before the upper end. In the crimped state, the tip of the V-shaped strengthening rod 61 faces downward, that is, when the positioning is inaccurate and the transcatheter heart valve replacement stent needs to be retrieved into the sheath tube, the tip of the V-shaped strengthening rod 61 faces downward.

[0076] Furthermore, the transcatheter heart valve replacement stent as a whole is radially compressed and stored in the sheath tube. In order to reduce the delivery size, the first end of the anchoring rod 300 is connected to the second end of the stent body 1 and integrally formed by tooling heat treatment. Refer toFigure 19 In the pressed state, the second end of the single anchor rod 300 is folded around the first end of the anchor rod 300, so that the anchor rod 300 extends along the axial direction of the stent body 1, that is, the anchor rod 300 is in a straightened state, and there is no overlap with the stent body 1 in the radial direction; in the unfolded state, the second end of the anchor rod 300 is folded around the first end of the anchor rod 300 in the opposite direction, so that the anchor rod 300 overlaps with the stent body 1 in the radial direction of the stent body 1. Figure 2 From the perspective of the orientation, in the gripping state, the tip of the V-shaped reinforcing rod 61 faces downward, and after being unfolded, the anchor rod 300 is folded outward around its first end to present a Figure 2 The state shown is the unfolded state, in which the tip of the V-shaped reinforcing rod 61 faces upward.

[0077] Existing replacement valves rely on radial support force for anchoring. In order to provide greater anchoring force, the overall radial size of the stent has to be increased, which will cause conduction block; in addition, the stent is larger in size after being pressed and gripped, which will increase the transport resistance and make the device difficult to transport. In the present invention, when in the pressed and gripped state, the anchor rod 300 can be folded to extend along the axial direction of the stent body 1, so that the transcatheter replacement valve stent has only a single layer in the pressed and gripped state. The stent body 1, the skirt structure 2, the anchor rod 300, the leaflet suture ear 8 and the transport connection structure 7 are connected as a whole, which can effectively reduce the transport size of the transcatheter replacement valve stent, ensure a smoother transport process, and at the same time ensure the recyclability of the transcatheter replacement valve stent. It should be noted that "recycling" here refers to retracting the released part into the sheath.

[0078] Furthermore, the first end of the stent body 1 is provided with a conveying connection structure 7, and the conveying connection structure 7 includes a plurality of connecting rods 71 arranged around the stent body 1, one end of the connecting rod 71 is connected to the first end of the stent body 1, and the other end of the connecting rod 71 extends away from the first end of the stent body 1 along the axial direction of the stent body 1, and a hanging portion 72 is provided at the end, and the hanging portion 72 is suitable for connecting with the conveying system. The hanging portion 72 is arranged protruding from the connecting rod 71, which is conducive to providing a fulcrum for connecting with the conveying system. At the same time, it can prevent the skirt structure 2 from generating impact force during the release process, causing the anchor 30 to shift or even cause heart damage. In this embodiment, six connecting rods 71 are arranged, and are evenly spaced around the stent body 1, and the hanging portion 72 is a crossbar arranged perpendicular to the connecting rod 71. Of course, the hanging portion 72 can also be a ring or other structure protruding from the connecting rod 71.

[0079] Furthermore, the stent body 1 is provided with a plurality of leaflet suture ears 8 around the stent body 1. Figure 1 , Figure 5 , Figure 6 and Figure 8, the leaflet suture ear 8 is a suture hole provided on the stent body 1, which provides support for the suture of the artificial valve 10 made of biological or non-biological flexible materials.

[0080] Embodiment 2

[0081] This embodiment provides a deformed implementation manner, which is different from Embodiment 1 in that the second end of the anchoring rod 300 is bent toward one side to form a protective structure 5. Bending the second end of the anchoring rod 300 toward one side makes the part of the anchoring rod 300 cooperating with the skirt support structure 2 a bent portion, rather than the end of the anchoring rod 300. That is, the bent portion of the anchoring rod 300 is in direct contact with the autologous leaflet 4 or the myocardial tissue 13. Since the bent portion is a smooth curve, it will not pierce the autologous leaflet 4 or the myocardial tissue 13, thus playing a protective role.

[0082] In addition, when the second end of the anchoring rod 300 is bent toward one side and cooperates with the skirt support structure 2, because the anchoring rod 300 has the ability of elastic deformation, the bent portion can provide a clamping force toward the inside of the stent body 1, and the first skirt support section 21 is bent toward the outside of the stent body 1. The two are arranged oppositely and cooperate with each other, thereby enhancing the clamping effect between the anchoring rod 300 and the skirt support structure 2 and making the clamping more stable.

[0083] Specifically, referring to Figures 9 - 17 , the second end of the anchoring rod 300 is bent inward, that is, bent close to the stent body 1; or, the second end of the anchoring rod 300 is bent outward, that is, bent away from the stent body 1.

[0084] Referring to Figure 9 and Figure 10 , in this embodiment, the second ends of the 12 anchoring rods 300 are all bent toward the inside of the stent body 1, and the bent arc is a major arc.

[0085] Embodiment 3

[0086] This embodiment provides a deformed implementation manner. Referring to Figure 11 and 12 , it is different from Embodiment 2 in that the second ends of the 12 anchoring rods 300 are bent outward, and the bent arc of the second end of the anchoring rod 300 is a major arc. Compared with the scheme in Embodiment 2 where the anchoring rod 300 is bent inward, the second end of the anchoring rod 300 in this embodiment is bent outward, which is easier to form during the heat treatment process, has higher production efficiency, and is more convenient for loading and releasing when cooperating with the delivery system.

[0087] Embodiment 4

[0088] This embodiment provides a deformed implementation manner. Referring to Figures 13 - 15, different from Embodiment 2, there are 12 anchoring rods 300, among which 6 adjacent anchoring rods 300 are the first clamping group 31 for clamping the anterior cusp 42, and the other 6 anchoring rods 300 are the second clamping group 32 for clamping the posterior cusp 41. In order to adapt to the physiological differences between the anterior cusp 42 and the posterior cusp 41 of the mitral valve, the second ends of the anchoring rods 300 in the first clamping group 31 are bent inward, and the bent arc is a minor arc. The second ends of the anchoring rods 300 in the second clamping group 32 are bent inward, and the bent arc is a major arc.

[0089] Of course, while the second ends of the anchoring rods 300 are bent, extension blocks 51 can also be provided, such as Figures 1 - 8 shown.

[0090] Embodiment 5

[0091] This embodiment provides a modified implementation manner. Refer to Figure 16 and Figure 17 , different from Embodiment 3, there are 12 anchoring rods 300, among which 6 adjacent anchoring rods 300 are the first clamping group 31 for clamping the anterior cusp 42, and the other 6 anchoring rods 300 are the second clamping group 32 for clamping the posterior cusp 41. In order to adapt to the physiological differences between the anterior cusp 42 and the posterior cusp 41 of the mitral valve, the second ends of the anchoring rods 300 in the first clamping group 31 are bent inward, and the bent arc is a minor arc. The second ends of the anchoring rods 300 in the second clamping group 32 are bent outward, and the bent arc is a major arc.

[0092] Of course, the anchoring structure 3 is not limited to the structures of the above 5 embodiments.

[0093] Embodiment 6

[0094] This embodiment provides a transcatheter valve replacement device, including the transcatheter valve replacement stent described in any one of Embodiments 1 - 5.

[0095] Furthermore, in this embodiment, the transcatheter valve replacement further includes a sealing skirt 9, and the structure of the sealing skirt 9 is as Figure 18 shown. Refer to Figure 8 , the sealing skirt 9 is connected to the skirt support structure 2, the sealing skirt 9 is disposed around the stent body 1 in a fitting manner on the inner side of the stent body 1, the first end of the sealing skirt 9 is connected to the skirt support structure 2, and the second end of the sealing skirt 9 extends toward the second end of the stent body 1.

[0096] Furthermore, as a modified implementation manner, as Figure 20 shown, the sealing skirt 9 can also be provided with a triangular extension section 91 at the distal end to give a higher sealing effect. The position where the sealing skirt 9 is sutured to the stent body 1 is as Figure 21 shown, and the triangular extension section 91 of the sealing skirt 9 is adapted to the triangular window exposed by the diamond grid of the stent body 1.

[0097] Furthermore, the transcatheter valve replacement stent also includes a leaflet suture ear 8, and the second end of the sealing skirt 9 partially or completely covers the leaflet suture ear 8, which can effectively enhance the sealing effect and prevent paravalvular leakage.

[0098] Furthermore, an artificial valve 10 is sutured and connected to the inner side of the stent body 1 through leaflet suture ears 8; the artificial valve 10 has two leaves, which is suitable for replacing the patient's mitral valve; or, the artificial valve 10 has three leaves, which is suitable for replacing the patient's aortic valve; or, the artificial valve has four leaves, which is suitable for the heart valves of special patients.

[0099] A percutaneous catheter is a catheter that is inserted through the skin with a needle. All catheters are hollow tubes that allow fluid to enter the body or allow excess body fluid to drain out of the body through the catheter into a suitable disposal container.

[0100] A method for using a transcatheter valve replacement device for a mitral valve comprises the following steps:

[0101] Step S1: Puncture one femoral vein of the patient, insert the guide wire and the puncture sheath into the right atrium, puncture the atrial septum 14, and enter the left ventricle 12 through the mitral valve;

[0102] Step S2: loading the transcatheter valve replacement device into a corresponding delivery system, and delivering the delivery system into the left ventricle 12 along the guidewire track;

[0103] Step S3: Adjust the direction of the delivery system according to the mark on the delivery system, so that the second clamping group 32 of the anchoring rod 300 turns to the posterior leaflet surface, release the anchoring rod 300, adjust the position so that the anchoring rod 300 of the second clamping group 32 is pushed to the root of the posterior leaflet, and the anchoring rod 300 of the first clamping group 31 is pushed to the root of the anterior leaflet, continue to release the leaflet suture ear 8 and the skirt support structure 2 at the atrial end, so that the skirt support structure 2 is supported at the bottom of the atrium, and finally release the delivery connection structure 7;

[0104] Step S4: withdraw the delivery system for the mitral valve intervention to the right atrium 11, insert the atrial septum occluder, occlude the atrial septum 14, and complete the operation.

[0105] In the above steps, the three steps of positioning, fixation and release are completed by unidirectional withdrawal of the sheath, which effectively reduces the radial dimension of the delivery system and reduces the compression and damage of the head end of the delivery system to the ventricular septum.

[0106] Operation process: Puncture the femoral vein through the atrial septum 14 approach, puncture the ventricular septum, establish a guidewire track from the left ventricle 12 to the right ventricle, insert the interventional transcatheter valve replacement device along the guidewire, release the anchor rod 300, withdraw the sheath, and release the artificial valve 10. Block the atrial septum 14, and the operation is completed.

[0107] According to the above description, the present patent application has the following advantages:

[0108] 1. The skirt support structure 2 and the anchoring structure 3 cooperate to form a clamping mechanism, which can clamp the autologous leaflet 4, prevent the displacement of the transcatheter replacement valve stent, and prevent paravalvular leakage;

[0109] 2. A protective structure 5 is provided at the end of the anchoring rod 300, which can effectively prevent the autologous leaflet 4 from being punctured or the myocardial tissue 13 from being stabbed;

[0110] 3. The multiple anchoring members 30 are divided into a first clamping group 31 and a second clamping group 32, which respectively adapt to the anterior cusp 42 and the posterior cusp 41 of the mitral valve. The differential setting is more suitable for the physiological characteristics of the mitral valve;

[0111] 4. The anchoring rod 300 is integrally connected with the stent body 1. When compressed and held, the stent body 1 and the anchoring rod 300 are of a single-layer structure, effectively reducing the delivery size and facilitating release and recovery.

[0112] Obviously, the above embodiments are only examples for clear illustration and not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation manners here. And the obvious changes or modifications derived therefrom are still within the protection scope of the present invention.

Claims

1. A transcatheter replacement valve stent, characterized in that, Comprising: A stent body (1), which is a cylindrically shaped frame structure that can be radially compressed and expanded, having a crimped state and an expanded state; A clamping mechanism disposed around the outer periphery of the stent body (1). The clamping mechanism includes a skirt support structure (2) and an anchoring structure (3) respectively connected to the stent body (1). When the stent body (1) is in the expanded state, the skirt support structure (2) and the anchoring structure (3) cooperate to be adapted to clamp the autologous valve leaflet (4); The anchoring structure (3) includes a plurality of anchor members (30) spaced around the outer periphery of the stent body (1). The anchor members (30) cooperate with the skirt support structure (2) to be used for clamping the autologous valve leaflet (4); The anchor member (30) includes an anchor rod (300). The first end of the anchor rod (300) is connected to the stent body (1). The second end of the anchor rod (300) extends towards the skirt support structure (2) and cooperates with the skirt support structure (2) to be used for clamping the autologous valve leaflet (4). A protective structure (5) is provided at the second end of the anchor rod (300); The second end of the anchor rod (300) is bent towards one side to form the protective structure (5); The arc formed by the bending of the second end of the anchor rod (300) is a major arc to adapt to the posterior cusp of the mitral valve; Or, the arc formed by the bending of the second end of the anchor rod (300) is a minor arc to adapt to the anterior cusp of the mitral valve; The plurality of anchor members (30) are divided into a first clamping group (31) and a second clamping group (32). The second ends of the anchor rods (300) of the first clamping group (31) are bent close to the stent body (1), and the second ends of the anchor rods (300) of the second clamping group (32) are bent away from the stent body (1).

2. The transcatheter replacement valve stent according to claim 1, characterized in that, The skirt support structure (2) is provided at the first end of the stent body (1). The skirt support structure (2) surrounds the stent body (1) for one week and expands towards the outside of the stent body (1).

3. The transcatheter replacement valve stent according to claim 2, wherein The skirt support structure (2) includes a first skirt support section (21) connected to the stent body (1) and a second skirt support section (22) connected to the first skirt support section (21). The first skirt support section (21) is bent outwards, and the second skirt support section (22) is bent inwards.

4. The transcatheter replacement valve stent according to any one of claims 1-3, characterized in that, The protective structure (5) includes an extension block (51) protruding from the anchor rod (300). The outer contour of the extension block (51) is a smooth curve.

5. The transcatheter replacement valve stent according to any one of claims 1-3, characterized in that, The second end of the anchor rod (300) is bent close to the stent body (1); or, the second end of the anchor rod (300) is bent away from the stent body (1).

6. The transcatheter replacement valve stent according to claim 1, wherein, A strengthening structure (6) is connected between two adjacent anchor rods (300).

7. The transcatheter replacement valve stent according to claim 6, wherein, The strengthening structure (6) includes a strengthening rod (61). The strengthening rod (61) is a combination of one or more of V-shaped, U-shaped, and W-shaped. The two ends of the strengthening rod (61) are respectively connected to two adjacent anchor members (30).

8. The transcatheter replacement valve stent according to claim 1, characterized in that, The first end of the anchor rod (300) is connected to the second end of the stent body (1). When the stent body (1) is in the compressed state, the anchor rod (300) does not overlap with the stent body (1) in the radial direction of the stent body (1).

9. The transcatheter replacement valve stent according to any one of claims 1-3, characterized in that, The first end of the stent body (1) is provided with a conveying connection structure (7). The conveying connection structure (7) includes a plurality of connecting rods (71) arranged around the stent body (1). One end of the connecting rod (71) is connected to the first end of the stent body (1). The other end of the connecting rod (71) extends axially away from the first end of the stent body (1) along the stent body (1), and a hanging portion (72) is arranged at the end. The hanging portion (72) is adapted to be connected to a conveying system.

10. The transcatheter replacement valve stent according to any one of claims 1-3, characterized in that, The stent body (1) is provided with a plurality of leaflet suture ears (8) around the stent body (1).

11. A transcatheter valve replacement device, characterized in that, Comprising the transcatheter replacement valve stent according to any one of claims 1-10.

12. The transcatheter replacement valve device according to claim 11, characterized in that, A sealing skirt cloth (9) is connected to the skirt support structure (2). The sealing skirt cloth (9) is disposed on the inner side of the stent body (1) in a fitting manner around the stent body (1). The first end of the sealing skirt cloth (9) is connected to the skirt support structure (2), and the second end of the sealing skirt cloth (9) extends towards the second end of the stent body (1).

13. The transcatheter valve replacement device according to claim 12, characterized in that, The transcatheter replacement valve stent further includes leaflet suture ears (8), and the second end of the sealing skirt cloth (9) partially or completely covers the leaflet suture ears (8).

14. The transcatheter valve replacement device according to any one of claims 11-13, characterized in that, The transcatheter replacement valve stent further includes leaflet suture ears (8). An artificial valve (10) is sutured and connected at the position of the leaflet suture ears (8) on the inner side of the stent body (1). Two pieces of the artificial valve (10) are provided and are adapted to replace the mitral valve of a patient; or, three pieces of the artificial valve (10) are provided and are adapted to replace the aortic valve of a patient; or, four pieces of the artificial valve (10) are provided and are adapted to the heart valve of a special patient.

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