Guiding device and method of anchoring a prosthetic valve

Abstract

The application provides a valve anchoring device, a guide device and a method for anchoring a prosthetic valve, mainly comprising an anchoring structure and a positioning member, wherein the anchoring structure has a first anchoring member and a second anchoring member extending from both sides of a combination member, the positioning member is connectable to the combination member, the combination member passes through a commissure of a leaflet of a heart tissue, the positioning member is positioned at one side of a heart atrioventricular valve adjacent to an atrium, the first anchoring member and the second anchoring member are positioned at one side of the heart atrioventricular valve adjacent to a ventricle, and the first anchoring member and the second anchoring member are cooperatively matched to anchor the prosthetic valve, so that the prosthetic valve is positioned relative to a native valve of the heart tissue. Therefore, the anchoring effect of the prosthetic valve can be improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a guiding device and an artificial valve anchoring method. Background Technology

[0002] The mitral valve, also known as the left atrioventricular valve, is a barrier between the left ventricle and left atrium. Normally, the opening and closing of the mitral valve is regulated by the pressure difference between the left atrium and left ventricle. During diastole, the pressure in the left atrium is greater than that in the left ventricle, and the mitral valve opens; conversely, during systole, the pressure in the left ventricle is greater than that in the left atrium, and the mitral valve closes. The mitral valve has a complex structure, consisting of the annulus, leaflets, chordae tendineae, and papillary muscles. Organic or functional changes in any of these components can lead to mitral regurgitation, meaning that the mitral valve cannot close completely during systole, allowing blood to flow backward into the left ventricle.

[0003] Treatment options for mitral regurgitation include valve repair and replacement, with valve replacement being the ultimate and fundamental solution. Current valve replacement procedures can be performed surgically or via catheter. For patients with high-risk factors such as impaired cardiac function, multiple comorbidities, or advanced age, catheter-based intervention is typically used.

[0004] Although transcatheter aortic valve replacement is a well-established treatment for aortic valve disease, and several transcatheter aortic valve products are available on the market, transcatheter mitral valves, while having seen various structural designs and delivery methods in recent years, are mostly still in the research stage. The main limiting factors are as follows: Due to the complex structure of the mitral valve—its overall structure is D-shaped compared to the aortic valve, with a larger annulus and less calcification—it cannot provide sufficient support for the artificial valve to fix it in place at the diseased mitral valve site. Anatomically, the left ventricular outflow tract is adjacent to the anterior leaflet of the mitral valve; implantation of the artificial mitral valve may cause left ventricular outflow tract obstruction, which needs to be considered and avoided in the design of the artificial valve. Furthermore, the larger annulus of the mitral valve means that if the artificial valve is a single-layer stent, a larger diameter stent is required compared to the aortic valve, which increases the corresponding leaflet area, reduces leaflet fatigue resistance, and increases the size of the delivery system, thereby increasing the risk of vascular complications. The tricuspid valve, as the atrioventricular valve of the right heart, has a similar structure to the atrioventricular valve (mitral valve) of the left heart. The same design principle used in mitral valve replacement can be applied to tricuspid valve replacement.

[0005] In conclusion, there is an urgent need for a valve anchoring product that can effectively improve the anchoring effect of artificial valves. Summary of the Invention

[0006] In view of the above problems, this application provides a valve anchoring device, a guiding device, and an artificial valve anchoring method to overcome or at least partially solve the above problems.

[0007] This application provides a valve anchoring device, comprising: an anchoring structure having a connecting member and a first anchoring member and a second anchoring member extending from both sides of the connecting member; a positioning member connected to the connecting member; wherein the connecting member passes through the leaflet fusion point of the heart tissue, the positioning member is located on the side of the atrioventricular valve adjacent to the atrium, and the first anchoring member and the second anchoring member are located on the side of the atrioventricular valve adjacent to the ventricle; the first anchoring member and the second anchoring member can cooperate to anchor an artificial valve, thereby positioning the artificial valve relative to the native valve of the heart tissue.

[0008] Optionally, the first anchor and the second anchor extend arcuately from opposite sides of the connector to form an anchoring ring, the inner diameter of which is smaller than the outer diameter of the artificial valve; the anchoring ring circumferentially surrounds the artificial valve and applies a radially inward force to the artificial valve to anchor it, thereby positioning the artificial valve relative to the native valve of the heart tissue.

[0009] Optionally, the anchoring ring includes an open anchoring ring, wherein the first anchor and the second anchor are respectively located at two free ends away from the connecting member, and are circumferentially interference-fitted along the open anchoring ring; or, the anchoring ring includes a closed anchoring ring, wherein the first anchor and the second anchor are respectively connected to each other at two free ends away from the connecting member.

[0010] Optionally, the first anchor and the second anchor may be symmetrically distributed on opposite sides of the connector, and the first anchor and the second anchor may have different arc diameters; or the first anchor and the second anchor may be staggered on opposite sides of the connector, and the first anchor and the second anchor may have the same or different arc diameters.

[0011] Optionally, the first anchoring member and / or the second anchoring member includes a plurality of anchoring strips spaced apart; wherein the number of anchoring strips constituting the first anchoring member and the number of anchoring strips constituting the second anchoring member may be equal or unequal.

[0012] Optionally, the cross-sections of the first anchor and the second anchor include at least one of the following: circular, elliptical, triangular, rectangular, and polygonal shapes.

[0013] Optionally, at least a portion of the surfaces of the first anchor and the second anchor have a polymer coating.

[0014] Optionally, the positioning element is arc-shaped, and the arc diameter of the positioning element is greater than the arc diameters of the first anchoring element and the second anchoring element.

[0015] Optionally, the anchoring structure includes a top anchoring unit and at least one non-top anchoring unit; wherein the top anchoring unit is located at the top of the anchoring structure and has the connecting member and first anchoring members and second anchoring members extending from both sides of the connecting member; each non-top anchoring unit is stacked below the top anchoring unit and has an assembly and first anchoring members and second anchoring members extending from both sides of the assembly; wherein the assembly is used to provide a connection between the current non-top anchoring unit and any adjacent non-top anchoring unit or the top anchoring unit.

[0016] Optionally, the assembly includes: a locking portion having a locking engagement unit; and a receiving portion having a receiving engagement unit; wherein the locking portion of the upper assembly can be inserted into the receiving portion of the lower assembly, and the locking engagement unit in the locking portion of the upper assembly can engage with the receiving engagement unit in the receiving portion of the lower assembly, so that the upper assembly and the lower assembly can be connected to each other.

[0017] Optionally, the locking part includes a locking rod, and the locking engagement unit includes a hook disposed on the locking rod; the receiving part includes a receiving groove, and the receiving engagement unit includes a protruding rib disposed on the receiving groove; the cross-section of the locking rod and the receiving groove respectively includes at least one of the following: circle, triangle, ellipse, rectangle, and polygon.

[0018] Optionally, the end of the receiving portion is formed with a slit; wherein the locking portion inserted in the receiving portion can apply a radially outward force to the receiving groove, so as to increase the gap of the slit and increase the inner diameter of the receiving portion.

[0019] Optionally, the end of the locking part is formed with a slit; wherein the receiving part can apply a radially inward force to the locking part inserted therein, so as to reduce the gap of the slit and reduce the inner diameter of the locking part.

[0020] Optionally, the connector is provided with a plurality of through holes at intervals; wherein each first anchor or each second anchor is movably inserted into each through hole to extend outward relative to the connector.

[0021] Optionally, the root of the first anchor or the second anchor is provided with a first limiting unit; wherein the through hole can restrict the passage of the first limiting unit to limit the maximum extension length of the first anchor or the second anchor relative to the connecting member.

[0022] Optionally, the through hole further includes a second limiting unit; wherein the second limiting unit is used to restrict the passage of the first limiting unit to limit the maximum extension length of the first anchor or the second anchor relative to the coupling.

[0023] Optionally, the device further includes an adjustment unit having multiple positioning portions, wherein the two opposite sides of the coupling member have a fixed side and a movable side; wherein the movable side is movable relative to the adjustment unit and positioned on any one of the positioning portions on the adjustment unit to adjust the distance between the fixed side and the movable side of the coupling member.

[0024] Optionally, the adjusting unit is located on opposite sides of the coupling; each positioning part is distributed at intervals along the axial direction of the adjusting unit; the movable side of the coupling can move along the axial direction of the adjusting unit under stress, so that the coupling undergoes elastic deformation, the distance between the fixed side and the movable side of the coupling is shortened, and the interval between each through hole is shortened; or, the coupling can elastically recover under non-stress state, so that the movable side moves in the opposite direction along the axial direction of the adjusting unit, the distance between the fixed side and the movable side of the coupling is increased, and the interval between each through hole is increased.

[0025] Optionally, the coupling includes: two coupling units, one of which can connect to a plurality of first anchors, and the other of which can connect to a plurality of second anchors; wherein the two coupling units can be combined with each other to position each first anchor relative to each second anchor.

[0026] Another embodiment of this application provides a guiding device that can be used in conjunction with the valve anchoring device described in some of the above embodiments. It includes: a body through which the connecting member passes; and a stop member disposed at the end of the body, which can switch between a non-stopping state and a stopping state. When the stop member is in the non-stopping state, it allows the guiding device to pass through the leaflet suture of the heart tissue to reach a designated location on the heart tissue, or allows the body to detach from the connecting member positioned at the designated location. When the stop member is in the stopping state, it allows the connecting member to be positioned at a designated location on the heart tissue, preventing the connecting member from detaching from the body.

[0027] Optionally, the stop includes at least one of a ball, a folding rod, and a woven mesh.

[0028] Another embodiment of this application provides a method for artificial valve anchoring, applied to the valve anchoring device described in the above embodiments, comprising: delivering an anchoring structure of the valve anchoring device into heart tissue using a delivery system, such that the connecting member of the anchoring structure passes through the leaflet commissure of the heart tissue; releasing a first anchor and a second anchor on the anchoring structure on the side of the atrioventricular valve adjacent to the ventricle to circumferentially surround the native valve of the heart tissue; delivering a positioning member of the valve anchoring device to the side of the atrioventricular valve adjacent to the atrium using the delivery system, and connecting the positioning member to the connecting member; delivering an artificial valve into the heart tissue using the delivery system, and anchoring the artificial valve by means of the first anchor and the second anchor.

[0029] Another embodiment of this application provides an artificial valve anchoring method applied to the valve anchoring devices described in the above embodiments, comprising: delivering the valve anchoring device into heart tissue using a delivery system, and having the connecting member of the valve anchoring device pass through the leaflet commissure of the heart tissue; releasing a first anchoring member and a second anchoring member of the valve anchoring device on the side of the atrioventricular valve adjacent to the ventricle to circumferentially surround the native valve of the heart tissue; releasing a positioning member of the valve anchoring device on the side of the atrioventricular valve adjacent to the ventricle; delivering an artificial valve into the heart tissue using the delivery system, and anchoring the artificial valve by means of the first anchoring member and the second anchoring member.

[0030] Another embodiment of this application provides a method for artificial valve anchoring, applied to the valve anchoring device described in the above embodiments, comprising: using a delivery system to deliver a connecting member of the valve anchoring device into the heart tissue and through the leaflet commissure of the heart tissue; using the delivery system to deliver a first anchor and a second anchor of the valve anchoring device to the side of the atrioventricular valve adjacent to the ventricle within the heart tissue, and releasing the first anchor and the second anchor to circumferentially surround the native valve of the heart tissue; using the delivery system to deliver a positioning member of the valve anchoring device to the side of the atrioventricular valve adjacent to the atrium, and connecting the positioning member to the connecting member; using the delivery system to deliver an artificial valve into the heart tissue, and anchoring the artificial valve by means of the first anchor and the second anchor.

[0031] Another embodiment of this application provides an artificial valve anchoring method, applied to the guiding device described in the above embodiments, comprising: using a delivery system to deliver the guiding device into the heart tissue, passing through the leaflet commissure of the heart tissue, until a designated position in the heart tissue; driving the stop of the guiding device to switch from a non-stop state to a stop state to define the anchoring position within the heart tissue; using the delivery system to sequentially deliver at least one non-top anchoring unit and a top anchoring unit to the anchoring position within the heart tissue and stacking them together to form a... An anchoring structure located at the anchoring position, and releasing the first and second anchoring elements of each of the at least one non-top anchoring unit and the top anchoring unit to circumferentially surround the native valve of the heart tissue; using the delivery system, the positioning element of the valve anchoring device is delivered to the side of the atrioventricular valve adjacent to the atrium, and the positioning element is connected to the top anchoring unit; using the delivery system, the artificial valve is delivered into the heart tissue, and the artificial valve is anchored by the first and second anchoring elements of each of the at least one non-top anchoring unit and the top anchoring unit.

[0032] In summary, the valve anchoring device provided in this application provides a method to anchor the artificial valve to the original valve location in the heart tissue by inserting the connecting member through the leaflet junction. This allows the positioning member to be positioned on the side of the atrioventricular valve adjacent to the atrium, and the first and second anchoring members to be positioned on the side of the atrioventricular valve adjacent to the ventricle. The artificial valve is anchored to the original valve location in the heart tissue by the first and second anchoring members. Therefore, this application can provide a better artificial valve anchoring effect, thereby improving the success rate of valve replacement surgery. Attached Figure Description

[0033] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings.

[0034] Figure 1 This is a schematic diagram of the overall structure of the valve anchoring device of this application.

[0035] Figures 2 to 3 This is a schematic diagram illustrating an application embodiment of the valve anchoring device of this application.

[0036] Figures 4A to 12B This is a schematic diagram of different local structures of the valve anchoring device of this application.

[0037] Figures 13A to 16B These are schematic diagrams of different embodiments of the guiding device for the valve anchoring device of this application.

[0038] Figures 17A to 20B Schematic diagrams of different embodiments of anchoring artificial valves using the valve anchoring device of this application.

[0039] Component designation

[0040] 1: Valve anchoring devices;

[0041] 10: Anchoring structure;

[0042] 102: Connecting component;

[0043] 102a: Active side;

[0044] 102b: Fixed side;

[0045] 104: First anchoring element;

[0046] 104a: Free end;

[0047] 106: Second anchoring element;

[0048] 106a: Free end;

[0049] 108: Anchoring ring;

[0050] 108a: Open anchoring ring;

[0051] 108b: Closed anchoring ring;

[0052] 110: Anchoring strip;

[0053] 112: Top anchoring unit;

[0054] 114: Non-top anchoring unit;

[0055] 116, 116A, 116B: Assemblies;

[0056] 118, 118A: Locking part;

[0057] 119: Locking lever;

[0058] 120, 120A: Locking and engaging unit;

[0059] 1201: Locking groove;

[0060] 1202: Locking lug;

[0061] 121: Hook;

[0062] 122, 122B: Reception section;

[0063] 123: Receiving slot;

[0064] 124, 124B: Acceptor locking unit;

[0065] 125: Convex rib;

[0066] 1251: Accommodating lug;

[0067] 1252: Accommodating groove;

[0068] 126, 127: Cutting seams;

[0069] 128: Through hole;

[0070] 130: First limiting unit;

[0071] 131: Stop unit;

[0072] 132: Second limiting unit;

[0073] 134: Adjustment unit;

[0074] 136: Positioning section;

[0075] 138: Tow rope;

[0076] 140, 140A, 140B: Combined unit;

[0077] 141A: Plugin;

[0078] 141B: Slot;

[0079] 142: Guiding device;

[0080] 144: Ontology;

[0081] 146: Stop component;

[0082] 20: Positioning components;

[0083] 3: Heart tissue;

[0084] 30: Native valve

[0085] 32: The junction of the petals;

[0086] 34: Atrioventricular valves;

[0087] 4: Artificial valve;

[0088] 5: Conveying system. Detailed Implementation

[0089] To enable those skilled in the art to better understand the technical solutions in the embodiments of this application, the technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art should fall within the protection scope of the embodiments of this application.

[0090] The specific implementation of the embodiments of this application will be further described below with reference to the accompanying drawings.

[0091] Figure 1 This is a three-dimensional structural diagram of the valve anchoring device 1, which is an exemplary embodiment of this application. As shown in the figure, the valve anchoring device 1 of this embodiment mainly includes an anchoring structure 10 and a positioning element 20.

[0092] The anchoring structure 10 has a coupling 102 and a first anchoring member 104 and a second anchoring member 106 extending from both sides of the coupling 102.

[0093] Optionally, the first anchor 104 and the second anchor 106 may extend arcuately from opposite sides of the coupling 102 to form an anchoring ring 108.

[0094] Optionally, the first anchor 104 and the second anchor 106 may have the same or different arc diameters.

[0095] Optionally, the cross-sections of the first anchor 104 and the second anchor 106 may include, but are not limited to, one of the following: circular, elliptical, triangular, rectangular, or polygonal shapes.

[0096] Specifically, the first anchor 104 and the second anchor 106 may be formed of wire or tube, wherein the cross-section of the wire or tube may include, but is not limited to, circular, elliptical, rectangular, etc.

[0097] In addition, the first anchor 104 and the second anchor 106 can also be cut from pipes or plates.

[0098] Furthermore, the ends of the two free ends 104a and 106a of the first anchor 104 and the second anchor 106 away from the connecting member 102 can form a protective structure. For example, the ends of the two free ends 104a and 106a can be designed as a circular structure to avoid scratching the heart tissue 3 during the operation of the first anchor 104 and the second anchor 106 moving relative to the heart tissue 3, thereby improving the safety of the surgical operation.

[0099] Optionally, at least a portion of the surfaces of the first anchor 104 and the second anchor 106 have a polymer coating (not shown) to prevent tissue infection.

[0100] Optionally, the first anchor 104 and the second anchor 106 and the connecting member 102 can be integrally molded.

[0101] Optionally, the first anchoring member 104 and the second anchoring member 106 can be fixedly connected to the connecting member 102 by means of welding, riveting, mechanical fitting, etc.

[0102] Optionally, the first anchor 104 and the second anchor 106 are movably connected to the coupling 102 to adjust the extension length of the first anchor 104 and the second anchor 106 relative to the coupling 102.

[0103] Positioning component 20 connects to component 102.

[0104] Optionally, the positioning element 20 may be arc-shaped.

[0105] Optionally, the arc diameter of the positioning element 20 may be greater than the arc diameter of the first anchor 104 and the second anchor 106 to improve the positioning effect of the positioning element 20 within the heart tissue 3.

[0106] Combination Figure 1 and Figure 2 The connecting member 102 passes through the leaflet junction 32 of the heart tissue 3, and the positioning member 20 can be located on the side of the atrioventricular valve 34 adjacent to the atrium (e.g., Figure 2 The first anchor 104 and the second anchor 106 can be located on the side of the atrioventricular valve 34 adjacent to the ventricle (as shown above the atrioventricular valve 34), that is, at the valve annulus of the heart tissue 3. Figure 2 (The lower side of the atrioventricular valve 34 shown).

[0107] refer to Figure 3 The first anchor 104 and the second anchor 106, located on the side of the atrioventricular valve 34 adjacent to the ventricle, can cooperate to anchor the artificial valve 4, thereby positioning the artificial valve 4 relative to the original valve 30 of the heart tissue 3.

[0108] Optionally, the anchoring ring 108 formed by the first anchoring member 104 and the second anchoring member 106 can circumferentially surround the artificial valve 4 and apply a radially inward force to the artificial valve 4 to anchor the artificial valve 4, so that the artificial valve 4 is positioned at the original valve 30 of the heart tissue 3, thereby realizing the docking between the artificial valve 4 and the original valve 30.

[0109] Specifically, the anchoring ring 108 formed by the first anchoring member 104 and the second anchoring member 106 can circumferentially surround the outer periphery of the original valve 30, and the artificial valve 4 can be released into the anchoring ring 108. Since the inner diameter of the anchoring ring 108 formed by the first anchoring member 104 and the second anchoring member 106 is smaller than the outer diameter of the artificial valve 4, the anchoring ring 108 can apply a radially inward force to the artificial valve 4 to achieve anchoring of the artificial valve 4, thereby indirectly positioning the artificial valve 4 at the original valve 30 within the heart assembly 3.

[0110] Therefore, the valve anchoring device 1 provided in this application can stably anchor the artificial valve 4 at a designated position within the heart tissue 3, achieving precise docking between the artificial valve 4 and the original valve 30, thereby effectively improving the success rate of valve replacement surgery.

[0111] Furthermore, the valve anchoring device provided in this application can be applied to mitral or tricuspid valve replacement surgery. In addition, when applied to mitral valve replacement, it can limit the maximum range of motion of the anterior leaflet by capturing the anterior and posterior leaflets within the ventricle between the first and second anchoring elements. This prevents excessive leaflet movement from obstructing normal blood flow into the left ventricular outflow tract and causing left ventricular outflow tract obstruction.

[0112] Optionally, the anchoring ring 108 formed by the first anchoring member 104 and the second anchoring member 106 may include an open anchoring ring 108a. In this case, the two free ends 104a and 106a of the first anchoring member 104 and the second anchoring member 106, respectively, away from the coupling member 102, may be interference-fitted circumferentially along the open anchoring ring 108a (see reference). Figure 1 ).

[0113] Optionally, when the artificial valve 4 is released into the open anchoring ring 108a, the artificial valve 4 can be used to open the first anchor 104 and the second anchor 106, so that the two free ends 104a and 106a of the interference fit fit together and form a closed anchoring ring 108 (see reference). Figure 4A This provides a more stable support for the artificial valve 4.

[0114] Optionally, the anchoring ring 108 formed by the first anchor 104 and the second anchor 106 may include a closed anchoring ring 108b, in which case the two free ends 104a, 106a of the first anchor 104 and the second anchor 106, respectively, away from the coupling 102, may be connected to each other.

[0115] refer to Figure 4BFor example, a locking structure (e.g., a bending structure) can be designed at the ends of the free ends 104a and 106a of the first anchor 104 and the second anchor 106, respectively, so that the ends of the free ends 104a and 106a can be locked together to form a closed anchoring ring 108b.

[0116] Optionally, the first anchoring member 104 and the second anchoring member 106 may be symmetrically distributed on opposite sides of the connecting member 102 (see reference). Figure 5 ), or staggered on opposite sides of the coupling 102 (see reference). Figure 6A ).

[0117] Optionally, when the first anchor 104 and the second anchor 106 are symmetrically distributed on opposite sides of the connecting member 102, the first anchor 104 and the second anchor 106 may have different arc diameters.

[0118] Optionally, when the first anchor 104 and the second anchor 106 are staggered on opposite sides of the connector 102, the first anchor 104 and the second anchor 106 may have the same or different arc diameters.

[0119] Optionally, the first anchor 104 and / or the second anchor 106 may include a plurality of anchor strips 110 spaced apart, thereby increasing the contact area between the first anchor 104 and / or the second anchor 106 and the artificial valve 4, thereby improving the anchoring effect of the artificial valve 4.

[0120] Those skilled in the art should know that the aforementioned anchoring strip 110 can also be presented as an anchoring band, which should be regarded as an equivalent implementation of the anchoring strip 110.

[0121] For example, the cross-section of the anchor bar 110 may include, but is not limited to, one of the following: circle, ellipse, triangle, rectangle, or polygon.

[0122] Optionally, in the same first anchor 104 or second anchor 106, the first and / or last ends of each anchor bar 110 may converge to form a single endpoint (see reference). Figure 7 ).

[0123] Optionally, the number of anchoring strips 110 constituting the first anchoring member 104 may be equal to or different from the number of anchoring strips 110 constituting the second anchoring member 106.

[0124] Optionally, a biocompatible polymer coating can be applied to the surface of each anchoring strip 110 or between two adjacent anchoring strips 110, which is beneficial for the adhesion of endothelial cells to the surface of the receiving device and accelerates the endothelialization of the device 1.

[0125] Optionally, the anchoring structure 10 may include a top anchoring unit 112 and at least one non-top anchoring unit 114 stacked together (see reference). Figure 5 , Figure 9B ).

[0126] like Figure 5 As shown, the top anchoring unit 112 is located on top of the anchoring structure 10 and has a connector 102 for connecting the positioning member 20, a first anchoring member 104 and a second anchoring member 106 extending from both sides of the connector 102. Each non-top anchoring unit 114 can be stacked sequentially below the top anchoring unit 112 and has a connector 116 and a first anchoring member 104 and a second anchoring member 106 extending from both sides of the connector 116.

[0127] Optionally, the top anchoring unit 112 and the positioning member 20 can be integrally formed, or the top anchoring unit 112 and the positioning member 20 can be fixed to each other by connection.

[0128] Optionally, the structures of the coupling 102 and the assembly 116 may be the same or different.

[0129] In this embodiment, assembly 116 is used to provide the current non-top anchoring unit 114 to connect to any adjacent non-top anchoring unit 114 or top anchoring unit 112.

[0130] Specifically, assembly 116 is used to provide connection between the current non-top anchoring unit 114 and any non-top anchoring unit 114 or top anchoring unit 112 stacked above it.

[0131] For example, an assembly 116 on the bottom non-top anchoring unit 114 of the anchoring structure 10 is used to connect to the penultimate non-top anchoring unit 114, or an assembly 116 on the second layer non-top anchoring unit 114 of the anchoring structure 10 is used to connect to the top anchoring unit 112 of the top layer, and so on.

[0132] Optionally, assembly 116 includes a locking part 118 and a receiving part 122.

[0133] refer to Figure 8A The locking part 118 has a locking engagement unit 120, and the receiving part 122 has a receiving engagement unit 124.

[0134] refer to Figure 9A and Figure 9BThe locking portion 118A of the upper assembly 116A can be inserted into the receiving portion 122B of the lower assembly 116B, and the locking engagement unit 120A in the locking portion 118A of the upper assembly 116A can engage with the receiving engagement unit 124B in the receiving portion 122B of the lower assembly 116B, so that the upper assembly 116A and the lower assembly 116B can be connected to each other, and the non-top anchoring unit 114A or the top anchoring unit 112 is stacked on top of the non-top anchoring unit 114B.

[0135] Optionally, the locking part 118 may include a locking rod 119, and the locking engagement unit 120 may include at least one hook 121 provided on the locking rod 119.

[0136] refer to Figure 8A and Figure 8B The locking rod 119 may have a circular cross-section, but is not limited to this. The cross-section of the locking rod 119 may also be designed as an ellipse, rectangle, triangle, polygon, etc.

[0137] Each hook 121 can be circumferentially arranged on the outer wall of the locking rod 119.

[0138] Optionally, the receiving portion 122 may include a receiving groove 123, and the receiving engaging unit 124 may include at least one protruding rib 125 provided on the receiving groove 123.

[0139] refer to Figure 8A and Figure 8B The cross-section of the receiving groove 123 is adapted to the cross-section of the locking rod 119, and can be designed as a circle, ellipse, rectangle, triangle, polygon, etc.

[0140] Each rib 125 can be circumferentially distributed on the inner wall of the receiving groove 123.

[0141] In this embodiment, each rib 125 may be distributed at intervals along the circumference of the receiving groove 123 on the inner wall of the receiving groove 123, or each rib 125 may be continuously distributed along the circumference of the receiving groove 123 on the inner wall of the receiving groove 123 to form a closed convex ring.

[0142] Optionally, the locking part 118 may be cylindrical, spherical, or the like.

[0143] In some embodiments, reference Figure 8C The receiving engagement unit 124 can be provided only on the inner wall of the receiving part 122. When the locking part 118 is inserted into the receiving part 122, the receiving engagement unit 124 of the receiving part 122 can abut against the outer wall of the locking part 118, so that the receiving part 122 and the locking part 118 are positioned relative to each other.

[0144] In other embodiments, reference is made to... Figure 8D The receiving engagement unit 124 includes receiving lugs 1251 circumferentially distributed on the inner wall of the receiving portion 122, and the locking engagement unit 120 includes locking grooves 1201 circumferentially distributed on the outer wall of the locking portion 118. The receiving lugs 1251 and the locking grooves 1201 are structurally compatible. When the locking portion 118 is inserted into the receiving portion 122, the receiving lugs 1251 and the locking grooves 1201 can engage with each other, so that the receiving portion 122 and the locking portion 118 are positioned relative to each other.

[0145] In other embodiments, reference is made to Figure 8E The receiving and engaging unit 124 includes receiving grooves 1252 circumferentially distributed on the inner wall of the receiving portion 122, and the locking and engaging unit 120 includes locking lugs 1202 circumferentially distributed on the outer wall of the locking portion 118. The receiving grooves 1252 and locking lugs 1202 are structurally compatible. When the locking portion 118 is inserted into the receiving portion 122, the receiving grooves 1252 and locking lugs 1202 can engage with each other, so that the receiving portion 122 and the locking portion 118 are positioned relative to each other.

[0146] Optionally, the end of the receiving portion 122 away from the locking portion 118 is formed with at least one slit 126.

[0147] refer to Figure 8B , Figure 10A , Figure 10B The slit 126 can be formed at the end of the receiving portion 122 along the axial direction of the receiving portion 122.

[0148] refer to Figure 10A and Figure 10B The locking part 118 inserted in the receiving part 122 can apply a radially outward force to the receiving part 122, so as to increase the gap of the slit 126 and increase the inner diameter of the receiving groove 123, thereby providing the locking part 118 to be positioned and inserted in the receiving part 122.

[0149] Optionally, a slit 127 is formed at the end of the locking portion 118 away from the receiving portion 122.

[0150] refer to Figure 10C and Figure 10D The slit 127 can be formed at the end of the locking part 118 along the axial direction of the locking part 118.

[0151] In this embodiment, the receiving portion 122 can apply a radially inward force to the locking portion 118 inserted therein, so as to reduce the gap of the slit 127 and reduce the outer diameter of the locking portion 118, thereby providing a positioning of the locking portion 118 in the receiving portion 122.

[0152] Optionally, the mating member 102 may be provided with a plurality of through holes 128 at intervals (see reference). Figure 5 ).

[0153] Each of the first anchoring members 104 or each of the second anchoring members 106 is movably inserted into each through hole 128 to extend outward relative to the connecting member 102.

[0154] Optionally, the root of the first anchor 104 or the second anchor 106 is provided with a first limiting unit 130, and the through hole 128 can restrict the passage of the first limiting unit 130 to limit the maximum extension length of the first anchor 104 or the second anchor 106 relative to the connecting member 102 (see reference). Figure 11B ).

[0155] For example, the cross-sectional area of ​​the first limiting unit 130 may be larger than the cross-sectional area of ​​the through hole 128 to restrict the first limiting unit 130 from passing through the through hole 128.

[0156] Optionally, the through hole 128 further includes a second limiting unit 132, wherein the second limiting unit 132 can restrict the passage of the first limiting unit 130 to limit the maximum extension length of the first anchor 104 or the second anchor 106 relative to the coupling 102 (see reference). Figure 11C ).

[0157] For example, the first limiting unit 130 and the second limiting unit 132 may be designed as wedge-shaped structures to restrict the first limiting unit 130 from passing through the second limiting unit 132.

[0158] Optionally, the first anchor 104 or the second anchor 106 is further provided with a stop unit 131, wherein the stop unit 131 can cooperate with the first limiting unit 130 to restrict the first anchor 104 or the second anchor 106 from moving along its axial direction relative to the through hole 128.

[0159] refer to Figure 11C and Figure 11D The first limiting unit 130 and the second limiting unit 132 cooperate to restrict the movement of the first anchor 104 or the second anchor 106 relative to the through hole 128 along the first direction F1. At the same time, the stop unit 131 can abut against the outer wall of the connector 102 to restrict the movement of the first anchor 104 or the second anchor 106 relative to the through hole 128 along the second direction F2 opposite to the first direction F1, thereby providing the first anchor 104 or the second anchor 106 to move relative to the connector 102.

[0160] Optionally, the valve positioning device 1 also includes an adjustment unit 134 having a plurality of positioning parts 136, and the opposite sides of the coupling 102 include a movable side 102a and a fixed side 102b.

[0161] The movable side 102a of the connector 102 can move relative to the adjustment unit 134 and be positioned on any one of the positioning parts 136 of the adjustment unit to adjust the distance between the fixed side 102b and the movable side 102a of the connector 102.

[0162] refer to Figure 11A , Figure 12A , Figure 12B The adjustment unit 134 may include two traction ropes 138 located on opposite sides of the coupling member 102, and the positioning part 136 may be distributed at intervals along the axial direction of the adjustment unit 134 (traction rope 138) on the adjustment unit 134 (traction rope 138).

[0163] For example, the positioning part 136 is a spring piece disposed on the adjustment unit 134 (traction rope 138) (see reference). Figure 12B ).

[0164] In one embodiment, the movable side 102a of the connector 102 can move along the axial direction of the adjustment unit 134 under stress, so that the connector 102 undergoes elastic deformation. In this case, the distance between the fixed side 102b and the movable side 102a of the connector 102 gradually shortens, and the spacing between the through holes 128 axially distributed on the connector 102 also gradually shortens.

[0165] In another embodiment, the coupling 102 can elastically recover in a non-stressed state, so that the movable side 102a moves in the opposite direction along the axis of the adjustment unit 134. In this case, the distance between the fixed side 102b and the movable side 102a of the coupling 102 gradually increases, and the spacing between the through holes 128 axially distributed on the coupling 102 also gradually increases.

[0166] Specifically, during the process of positioning the anchoring structure 10 onto the heart tissue 3, the connector 102 can be kept in an elastically open state under non-stress conditions to facilitate the installation of each first anchor 104 and each second anchor 106. After the installation of each first anchor 104 and each second anchor 106 is completed, a force is applied to the movable side 102a of the connector 102, causing the connector 102 to be elastically compressed, thereby shortening the distance between each first anchor 104 and each second anchor 106, thereby increasing the support force of the first anchor 104 and the second anchor 106 on the artificial valve 4.

[0167] Optionally, the coupling 102 includes two coupling units 140A and 140B.

[0168] like Figure 6A , Figure 6BAs shown, one of the two connecting units (e.g., connecting unit 140A) can connect to a plurality of first anchors 104, and the other of the two connecting units (e.g., connecting unit 140B) can connect to a plurality of second anchors 106.

[0169] The two connecting units 140A and 140B can be combined with each other to position each first anchor 104 relative to each second anchor 106.

[0170] For example, the end of the connecting unit 140A may be provided with a plug 141A, and the end of the connecting unit 140B may be provided with a slot 141B, wherein the plug 141A can be fixedly inserted into the slot 141B so that the connecting units 140A and 140B can be fixedly combined.

[0171] Optionally, the valve anchoring device 1 also includes a guide device 142 for guiding the anchoring structure 10 to a designated location within the cardiac tissue 3.

[0172] refer to Figure 9A The guiding device 142 may include a body 144 and a stop 146.

[0173] The guiding device 142 of this embodiment is applicable to anchoring structures 10 consisting of multiple anchoring units (e.g., non-top anchoring units and top anchoring units) arranged in a stacked manner.

[0174] The body 144 can be used to insert the connecting member 102 of the anchoring structure 10, and the stop member 146 is provided at the end of the body 144 and can switch between the non-stop state and the stop state.

[0175] In one embodiment, when the stop member 146 is in a non-stopping state (see reference) Figure 9A , Figure 13A , Figure 14A , Figure 15A , Figure 16A The guide device 142 may be provided to pass through the leaflet junction 32 of the heart tissue 3 to reach a designated location in the heart tissue 3 (e.g., the side of the atrioventricular valve 34 adjacent to the ventricle), or the body 144 may be provided to disengage from the junction 102 after the coupling 102 of the anchoring structure 10 is positioned in a designated location within the heart tissue 3 (e.g., the coupling 102 passes through the leaflet junction 32 of the heart tissue 3).

[0176] In another embodiment, when the stop member 146 is in the stop state (see reference) Figure 13B , Figure 14B , Figure 15B , Figure 16B The connector 102 can be positioned at a designated location in the heart tissue 3 to prevent the connector 102 from detaching from the body 144.

[0177] Optionally, the stop member 146 in the stop state may have a rectangular cross-section or a circular cross-section, etc.

[0178] Optionally, the stop 146 may include, but is not limited to, a balloon structure ( Figure 14A , Figure 14B L-shaped folding bar ( Figure 13A , Figure 13B ), V-shaped folding bar ( Figure 16A , Figure 16B ), woven mesh ( Figure 15A , Figure 15B )one of the.

[0179] This embodiment also provides a variety of artificial valve positioning methods, which can be implemented in conjunction with the valve anchoring device 1 described in the above embodiments.

[0180] Example 1

[0181] The artificial valve localization method in this embodiment mainly includes the following steps:

[0182] The valve anchoring device 1's anchoring structure 10 is delivered into the heart tissue 3 using the delivery system 5, such that the connector 102 of the anchoring structure 10 passes through the leaflet junction 32 of the heart tissue 3 (see reference). Figure 2 ).

[0183] On the side of the atrioventricular valve 34 adjacent to the ventricle, the first anchor 104 and the second anchor 106 on the anchoring structure 10 are released until the first anchor 104 and the second anchor 106 circumferentially surround the native valve 30 of the heart tissue 3 (reference). Figure 17A , Figure 17B , Figure 18 ).

[0184] refer to Figure 19 The first anchor 104 or the second anchor 106 is further provided with a control member 105, which can control the elastic deformation of the first anchor 104 and the second anchor 106 under the force of the control member 105, forming an opening structure similar to a fish mouth clamp, so as to capture the original valve 30 (e.g., anterior and posterior leaflets) of the heart tissue 3 between the first anchor 104 and the second anchor 106. Then, the control member 105 can be released, so that the first anchor 104 and the second anchor 106 elastically recover in a non-stressed state, so as to form an anchoring ring 108 circumferentially surrounding the original valve 30 (see reference). Figure 2 ).

[0185] The positioning element 20 of the valve anchoring device 1 is delivered to the side of the atrioventricular valve 34 adjacent to the atrium using the delivery system 5, and the positioning element 20 is connected to the coupling element 102 (reference). Figure 2 ).

[0186] Specifically, the positioning element 20 of the valve anchoring device 1 can be delivered to the side of the atrioventricular valve 34 adjacent to the atrium using the delivery system 5, and the positioning element 20 can be released so that it connects to the coupling 102 and is located on the side of the atrioventricular valve 34 adjacent to the atrium.

[0187] The artificial valve 4 is delivered into the heart tissue 3 using the delivery system 5, and the artificial valve 4 is anchored by the first anchor 104 and the second anchor 106.

[0188] Specifically, the artificial valve 4 can be delivered into the heart tissue 3 and released into the anchoring ring 108 formed by the first anchoring member 104 and the second anchoring member 106. The radially inward compressive force applied to the artificial valve 4 by the anchoring ring 108 anchors the artificial valve 4 within the anchoring ring 108, thus achieving the mutual docking of the artificial valve 4 and the native valve 30 (see reference). Figure 3 ).

[0189] Optionally, the artificial valve positioning method of Embodiment 1 described above can be applied to, for example... Figure 1 , Figure 2 , Figure 7 , Figure 17A , Figure 17B , Figure 18 The illustrated embodiment.

[0190] Example 2

[0191] The artificial valve localization method in this embodiment mainly includes the following steps:

[0192] The valve anchoring device 1 is delivered into the heart tissue 3 using the delivery system 5, and the connector 102 of the valve anchoring device 1 passes through the leaflet junction 32 of the heart tissue 3 (see reference). Figure 2 ).

[0193] On the side of the atrioventricular valve 34 adjacent to the ventricle, the first anchor 104 and the second anchor 106 of the valve anchoring device 1 are released until the first anchor 104 and the second anchor 106 circumferentially surround the native valve 30 of the heart tissue 3 (reference). Figure 17A , Figure 17B , Figure 18 ).

[0194] On the side of the atrioventricular valve 34 adjacent to the atrium, the positioning element 20 of the valve anchoring device 1 is released to position the valve anchoring device 1 as a whole relative to the heart tissue 3 (see reference). Figure 2 ).

[0195] The artificial valve 4 is delivered into the heart tissue 3 using the delivery system 5, and anchored by the first anchor 104 and the second anchor 106 (see reference). Figure 3 ).

[0196] Optionally, the artificial valve positioning method of Embodiment 2 described above can be applied to, for example... Figure 1 , Figure 2 , Figure 7 , Figure 17A , Figure 17B , Figure 18 The illustrated embodiment.

[0197] Example 3

[0198] The artificial valve localization method in this embodiment mainly includes the following steps:

[0199] The valve anchoring device 1's connector 102 is delivered into the heart tissue 3 using the delivery system 5, passing through the leaflet suture 32 of the heart tissue 3 (see reference). Figure 20A ).

[0200] The first anchor 104 and the second anchor 106 of the valve anchoring device 1 are delivered to the side of the atrioventricular valve 34 adjacent to the ventricle within the heart tissue 3 using the delivery system 5, and the first anchor 104 and the second anchor 106 are released until the first anchor 104 and the second anchor 106 circumferentially surround the native valve 30 of the heart tissue 3.

[0201] Specifically, the first anchor 104 and the second anchor 106 of the valve anchoring device 1 can be delivered to the coupling 102 located at the leaflet fusion joint 32, and the first anchor 104 and the second anchor 106 can be released on the side of the atrioventricular valve 34 adjacent to the ventricle through the various through holes 128 on the coupling 102, until the first anchor 104 and the second anchor 106 circumferentially surround the original valve 30 of the heart tissue 3 (see reference). Figure 20B ).

[0202] The positioning element 20 of the valve anchoring device 1 is delivered to the side of the atrioventricular valve 34 adjacent to the atrium using the delivery system 5, and the positioning element 20 is connected to the coupling element 102 (reference). Figure 2 ).

[0203] The artificial valve 4 is delivered into the heart tissue 3 using the delivery system 5, and anchored by the first anchor 104 and the second anchor 106 (see reference). Figure 3 ).

[0204] Optionally, the artificial valve positioning method of Embodiment 3 described above can be applied to, for example, Figure 1 , Figure 2 , Figure 5 , Figure 6A , Figure 7 , Figure 17A , Figure 17B , Figure 18 The illustrated embodiment.

[0205] Alternatively, when the coupling 102 is composed of coupling units 140A and 140B (see reference) Figure 6A First, the conveying system 5 can be used to transport the connecting unit 140B and connecting unit 140A to appropriate positions in the heart tissue 3. Then, the first anchor 104, the second anchor 106, and the positioning element 20 can be transported into the heart tissue 3 and assembled sequentially. After assembly, the conveying system 5 can be used to control the movement of connecting unit 140B relative to connecting unit 140A so that connecting units 140B and connecting unit 140A engage with each other to form connecting unit 102 (see reference). Figure 6B The free ends 104a and 106a of the first anchoring unit 104 and the second anchoring unit 106 are brought into contact with or locked together to increase the clamping force of the anchoring structure 10.

[0206] Example 4

[0207] The artificial valve anchoring method of this embodiment can be implemented in conjunction with the guidance device described in the above embodiments, and mainly includes the following steps:

[0208] The guide device 142 is delivered into the heart tissue 3 using the delivery system 5, and passes through the leaflet junction 32 of the heart tissue 3 until it reaches the designated location in the heart tissue 3.

[0209] The stop member 146 of the drive guide device 142 switches from the non-stop state to the stop state (reference). Figure 9A ), to define the anchoring location within the heart tissue 3;

[0210] Using the delivery system 5, at least one non-top anchoring unit 114 and a top anchoring unit 112 are sequentially delivered to the anchoring position within the heart tissue 3 and stacked together to form an anchoring structure 10 located at the anchoring position. At least one first anchoring element 104 and a second anchoring element 106 of each of the non-top anchoring unit 114 and the top anchoring unit 112 are released to circumferentially surround the native valve 30 of the heart tissue 3.

[0211] The positioning element 20 of the valve anchoring device 1 is delivered to the side of the atrioventricular valve 34 adjacent to the atrium using the delivery system 5, and the positioning element 20 is connected to the top anchoring unit 112.

[0212] The artificial valve 4 is delivered into the heart tissue 3 using the delivery system 5, and anchored by the first anchor 104 and the second anchor 106 of at least one non-apex anchoring unit 114 and the apex anchoring unit 112, respectively.

[0213] Optionally, the artificial valve positioning method of Embodiment 4 described above can be applied to, for example... Figure 5 , Figure 9A , Figure 9B The example shown.

[0214] Optionally, when the positioning element 20 and the top anchoring unit 112 are integrally connected, the top anchoring unit 112 and the positioning element 20 can be transported together into the heart tissue 3 using the delivery system 5, and the top anchoring unit 112 can be transported to the side of the atrioventricular valve 34 adjacent to the ventricle to combine with the non-top anchoring unit 114, and the positioning element 20 can be transported to the side of the atrioventricular valve 34 adjacent to the atrium, and the first anchoring element 104 and the second anchoring element 106 of the top anchoring unit 112 and the positioning element 20 can be released together in the heart tissue 3, so that the valve anchoring device 1 is positioned relative to the heart tissue 3.

[0215] In summary, the valve anchoring device of this application, by inserting the connecting member into the leaflet fusion site of the heart tissue, allows the positioning member connecting the connecting member to be positioned on opposite sides of the atrioventricular valve, and the first anchoring member and the second anchoring member to anchor the artificial valve to the native valve of the heart tissue. In this way, the present application can improve the anchoring effect of the artificial valve, which is conducive to the precise docking between the artificial valve and the native valve, thereby improving the success rate of valve replacement surgery.

[0216] The valve anchoring device of this application, through the design of the first anchor and the second anchor surrounding the native valve of the heart tissue, limits the maximum swing amplitude of the native valve, thereby effectively avoiding the obstruction of the normal flow of blood into the left ventricular outflow tract and causing left ventricular outflow tract obstruction due to the swing of the anterior leaflet toward the left ventricular outflow tract.

[0217] The valve anchoring device of this application, through the structural design of a first anchoring member and a second anchoring member having the same or different arc diameters to form an open anchoring ring or a closed anchoring ring, can not only improve the anchoring effect of artificial valves, but also flexibly meet the application needs of different scenarios.

[0218] The valve anchoring device of this application increases the contact area between the first anchor and / or the second anchor and the artificial valve by arranging multiple anchoring strips at intervals in the first anchor and / or the second anchor, thereby further improving the anchoring effect of the artificial valve.

[0219] The valve anchoring device of this application, through its structural design that the arc diameter of the positioning element is larger than that of the first anchoring element and the second anchoring element, allows the positioning element to be stably positioned relative to the heart tissue, which is beneficial to improving the positioning effect of the artificial valve relative to the heart tissue.

[0220] The valve anchoring device of this application can effectively increase the support force of the anchoring structure for the artificial valve by stacking multiple anchoring units (including top anchoring units and non-top anchoring units).

[0221] The valve anchoring device of this application uses an adjustment unit to adjust the spacing between each first anchor or each second anchor, which can flexibly meet the installation and application requirements of the anchoring structure.

[0222] The valve anchoring device of this application, by providing a guide device, can facilitate the positioning of the anchoring structure within the heart tissue.

[0223] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of this application, and are not intended to limit them; although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A guide device, which is used in combination with a valve anchoring apparatus, wherein: the valve anchoring apparatus comprises: an anchoring structure having a coupling member and a first anchoring member and a second anchoring member extending from two sides of the coupling member; a positioning member connected to the coupling member; wherein: the coupling member passes through a commissure of leaflets of a heart tissue, the positioning member is located on a side of a heart atrioventricular valve adjacent to an atrium, and the first anchoring member and the second anchoring member are located on a side of the heart atrioventricular valve adjacent to a ventricle; the first anchoring member and the second anchoring member are cooperatively configured to anchor a prosthetic valve so that the prosthetic valve is positioned relative to a native valve of the heart tissue; the anchoring structure comprises a top anchoring unit and at least one non-top anchoring unit; wherein: the top anchoring unit is located at a top of the anchoring structure and has the coupling member and the first anchoring member and the second anchoring member extending from two sides of the coupling member; each non-top anchoring unit is sequentially stacked below the top anchoring unit and has a combination member and the first anchoring member and the second anchoring member extending from two sides of the combination member; wherein the combination member is configured to provide a current non-top anchoring unit to be connected to any one of the non-top anchoring units or the top anchoring unit which is arranged adjacent to the current non-top anchoring unit; the guide device comprises: a body which is arranged through the coupling member; a stopper which is arranged at an end of the body and is switchable between a non-stop state and a stop state; when the stopper is in the non-stop state, the guide device is provided to pass through the commissure of leaflets of the heart tissue to reach a designated position or to provide the body to be separated from the coupling member which is positioned at the designated position; when the stopper is in the stop state, the coupling member is provided to be positioned at the designated position of the heart tissue to prevent the coupling member from being separated from the body. 2.The guide device according to claim 1, wherein: the first anchoring member and the second anchoring member extend in an arc shape from opposite sides of the coupling member to form an anchoring ring, an inner diameter of the anchoring ring is smaller than an outer diameter of the prosthetic valve; the anchoring ring circumferentially surrounds the prosthetic valve and applies a radially inward force to the prosthetic valve to anchor the prosthetic valve so that the prosthetic valve is positioned relative to the native valve of the heart tissue. 3.The guide device according to claim 2, wherein: the anchoring ring comprises an open anchoring ring, two free ends of the first anchoring member and the second anchoring member which are away from the coupling member are circumferentially interference-fitted along the open anchoring ring; or the anchoring ring comprises a closed anchoring ring, the two free ends of the first anchoring member and the second anchoring member which are away from the coupling member are connected to each other. 4.The guide device according to claim 2, wherein: the first anchoring member and the second anchoring member are symmetrically distributed on opposite sides of the coupling member, and the first anchoring member and the second anchoring member have different arc diameters; or The first and second anchors can be staggered on opposite sides of the coupling member, and the first and second anchors can have the same or different arc diameters.

5. The guide device of claim 1, wherein, The first anchor and / or the second anchor comprises at least one anchor strip arranged at intervals. The number of anchor strips constituting the first anchor can be equal to or different from the number of anchor strips constituting the second anchor.

6. The guide device according to any one of claims 1 to 5, characterized in that The cross section of the first anchor and the second anchor comprises at least one of a circle, an ellipse, a triangle, a rectangle, and a polygon.

7. The guide device according to any one of claims 1 to 5, characterized in that At least part of the surface of the first anchor and the second anchor has a polymer coating.

8. The guide device of claim 2, wherein, The positioning member is arc-shaped, and the arc diameter of the positioning member is greater than the arc diameter of the first anchor and the second anchor.

9. The guide device of claim 1, wherein, The anchoring structure comprises a top anchor unit and at least one non-top anchor unit. The top anchor unit is located at the top of the anchoring structure and comprises the coupling member and the first and second anchors extending from both sides of the coupling member. Each non-top anchor unit is sequentially stacked below the top anchor unit and comprises the coupling member and the first and second anchors extending from both sides of the coupling member. The coupling member is used to connect the current non-top anchor unit with any one of the non-top anchor units or the top anchor unit arranged adjacent thereto.

10. The guide device of claim 9, wherein, The coupling member comprises: a locking portion having a locking engagement unit; a receiving portion having a receiving engagement unit; The locking portion of the upper coupling member can be inserted into the receiving portion of the lower coupling member, and the locking engagement unit in the locking portion of the upper coupling member can be engaged with the receiving engagement unit in the receiving portion of the lower coupling member to connect the upper coupling member with the lower coupling member.

11. The guide device of claim 10, wherein, The locking portion comprises a locking rod, and the locking engagement unit comprises a hook provided on the locking rod. The receiving portion comprises a receiving slot, and the receiving engagement unit comprises a protruding rib provided on the receiving slot. The cross section of the locking rod and the receiving slot comprises at least one of a circle, a triangle, an ellipse, a rectangle, and a polygon.

12. The guide device of claim 11, wherein, The end of the receiving portion is formed with a slit; wherein the locking portion inserted into the receiving portion can exert a radially outward force on the receiving slot to increase the gap of the slit and increase the inner diameter of the receiving portion; or The end of the locking portion is formed with a slit; wherein the receiving portion can exert a radially inward force on the locking portion inserted therein to reduce the gap of the slit and reduce the outer diameter of the locking portion.

13. The guide device of claim 1, wherein, A plurality of through holes are arranged at intervals on the coupling member; Each first anchor or each second anchor is movably arranged in each through hole to extend outward relative to the coupling member.

14. The guiding device of claim 13, wherein, a root of the first anchor or the second anchor is provided with a first limiting unit; wherein the through hole is configured to limit the first limiting unit to pass through, so as to limit the maximum extension length of the first anchor or the second anchor relative to the coupling member.

15. The guide device of claim 14, wherein, the through hole further comprises a second limiting unit; wherein the second limiting unit is configured to limit the first limiting unit to pass through, so as to limit the maximum extension length of the first anchor or the second anchor relative to the coupling member.

16. The guide device of claim 13, wherein, the device further comprises an adjusting unit provided with a plurality of positioning portions, and opposite sides of the coupling member comprise a movable side and a fixed side; wherein the movable side is movable relative to the adjusting unit and is positioned on any one of the positioning portions of the adjusting unit, so as to adjust the distance between the fixed side and the movable side of the coupling member.

17. The guiding device of claim 16, wherein, the adjusting unit is located on the opposite sides of the coupling member; each positioning portion is spaced apart along the axial direction of the adjusting unit and is distributed on the adjusting unit; the movable side of the coupling member is movable along the axial direction of the adjusting unit under a force state, so as to cause the coupling member to be elastically deformed, the distance between the fixed side and the movable side of the coupling member is shortened, and the interval distance of each through hole is shortened; alternatively, the coupling member is elastically restored under a non-force state, so as to cause the movable side to move reversely along the axial direction of the adjusting unit, the distance between the fixed side and the movable side of the coupling member is increased, and the interval distance of each through hole is increased.

18. The guide device of claim 1 or 13, wherein, the coupling member comprises: two coupling units, one of the two coupling units is connectable to a plurality of first anchors, and the other of the two coupling units is connectable to a plurality of second anchors; wherein the two coupling units are combined with each other, so as to position each first anchor relative to each second anchor.

19. The guide device of claim 1, wherein, the stopper comprises at least one of a balloon, a folding rod, and a woven mesh.

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