Implant for reducing the risk of detachment, transcatheter constriction ring system and its application

Abstract

The present application discloses an implant, a transcatheter constriction ring system and their applications for reducing the risk of detachment. The implant includes a tightening wire and a plurality of anchoring components. The anchoring component includes an anchor and a threading structure rotatably sleeved on the anchor. The anchor is used for anchoring into heart tissue, and the threading structure is used for connecting the tightening wire. Among them, after a plurality of anchoring components are arranged along the circumferential direction of the heart tissue, the tightening wire is connected to the threading structure, and the tightening wire is located on the same side of the plurality of anchors that are anchored into the heart tissue. In this way, it can be ensured that after the constriction ring is completed, the anchoring components in the middle part are less stressed and the stress is more uniform, avoiding the situation where the anchoring components are stressed greatly, reducing the risk of detachment of the anchoring components, and making the implant safer; at the same time, the acting force of the anchoring components on the heart tissue is reduced, reducing the risk of damage to the heart tissue. In addition, when the tightening wire is tightened to form a constriction ring, the tightening wire moves stably and smoothly, ensuring the stability of the constriction ring and good constriction effect.

Description

[0001] This application claims the priority of a Chinese patent application with the application number 202111032580.9 and the application title "Wire-avoiding conveying device and transcatheter annuloplasty system" filed with the Chinese Patent Office on September 3, 2021, the entire content of which is incorporated herein by reference. Technical Field

[0002] This application relates to the technical field of medical devices, and in particular, to an implant, a transcatheter annuloplasty system for reducing the risk of detachment, and their applications. Background Art

[0003] Mitral regurgitation and tricuspid regurgitation are common heart valve diseases. The traditional treatment method is to perform valve repair or replacement through surgery to relieve the symptoms of patients and extend their lifespan. However, surgery has the disadvantages of large trauma, slow recovery, and high risk. In recent years, the treatment of mitral regurgitation and tricuspid regurgitation through minimally invasive interventional methods has gradually become a research hotspot. Among them, annuloplasty is a common interventional repair method. A number of anchors connected in series by sutures are implanted on the mitral valve annulus or tricuspid valve annulus, and the distance between the anchors is reduced to reduce the annulus size of the patient to achieve the purpose of reducing blood reflux. However, during the process of shrinking the annulus, there may be a large difference in the tension of the sutures on the anchors at different positions on the annulus, especially the anchors in the middle part. The anchors subjected to greater tension are prone to detachment during the surgical recovery process, leading to a series of complications. Summary of the Invention

[0004] In a first aspect, this application provides an implant for reducing the risk of detachment. The implant includes a tightening wire and a plurality of anchoring components. The anchoring component includes an anchor and a threading structure rotatably sleeved on the anchor. The anchor is used for anchoring into heart tissue, and the threading structure is used for connecting the tightening wire. After a plurality of the anchoring components are arranged along the circumferential direction of the heart tissue, the tightening wire connects the threading structure, and the tightening wire is located on the same side of the plurality of anchors anchored into the heart tissue.

[0005] In a second aspect, this application further provides a transcatheter annuloplasty system. The transcatheter annuloplasty system includes a conveying device and the implant as described above. The conveying device includes a conveying sheath, and the conveying sheath is used for conveying the anchoring component to the heart tissue. Wherein, a through groove extending from the distal end to the proximal end is formed in the wall of the conveying sheath. The through groove communicates with the inner cavity of the conveying sheath, and the distal end of the through groove has an opening. The threading structure is provided with a clamping end. When the anchor is movably inserted into the inner cavity of the conveying sheath, the clamping end can axially move and be located in the through groove.

[0006] In a third aspect, the present application also provides an application of the transcatheter annulus reduction system as described above, which is used to reduce the annulus during annuloplasty or reduce the ventricular volume during ventricular volume reduction surgery.

[0007] In the implant, transcatheter annulus reduction system and its application provided by the present application for reducing the risk of detachment, after a plurality of anchoring components are arranged along the circumferential direction of the heart tissue, the tightening wire is located on the same side of the plurality of anchors anchored into the heart tissue, which can ensure that after the annulus reduction is completed, the anchoring components in the middle part are less stressed and the stress is more uniform, avoiding the situation where the anchoring components are stressed greatly, reducing the risk of detachment of the anchoring components, and making the implantation safer; at the same time, the acting force of the anchoring components on the heart tissue is reduced, reducing the risk of damage to the heart tissue. In addition, when tightening the tightening wire to reduce the annulus, the tightening wire moves stably and smoothly, ensuring the stability of the annulus reduction and good annulus reduction effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0009] Figure 1 It is a schematic diagram of the implant implanted in the mitral valve annulus and the tightening wire tightened according to an embodiment of the present application.

[0010] Figure 2 It is a schematic diagram of the implant implanted in the tricuspid valve annulus and the tightening wire tightened according to an embodiment of the present application.

[0011] Figure 3 It is another schematic diagram of the implant implanted in the tricuspid valve annulus and the tightening wire tightened according to an embodiment of the present application.

[0012] Figure 4 It is a schematic diagram of the connection between the anchoring component and the anchoring device according to an embodiment of the present application.

[0013] Figure 5 It is a schematic diagram of the anchoring component being mounted on the distal end of the delivery sheath according to an embodiment of the present application.

[0014] Figure 6 It is Figure 2 The enlarged view of part VI in

[0015] Figure 7 It is Figure 5 A schematic diagram of the through groove of the delivery sheath in facing the mitral valve orifice.

[0016] Figure 8 It isFigure 5 Schematic diagram of the through groove of the delivery sheath in

[0017] Figure 9 the direction of the tricuspid valve orifice.

[0018] Figure 10 Schematic diagram of the structure of the anchoring component provided by an embodiment of the present application.

[0019] Figure 11 It is Figure 10 Schematic diagram of the three-dimensional exploded structure of the anchoring component in

[0020] Figure 12 Schematic diagram of the connection of the delivery member, the tightening wire and the first anchoring component provided by an embodiment of the present application.

[0021] Figure 13 It is Figure 10 Schematic diagram of the threading of the anchoring component in

[0022] Figure 14 and Figure 15 It is Figure 10 Schematic diagram of the threading of the anchoring component in

[0023] Figure 16 Schematic diagram of the structure of the anchoring component provided by another embodiment of the present application.

[0024] Figure 17 It is Figure 16 Schematic diagram of the three-dimensional exploded structure of the anchoring component in

[0025] Figure 18 It is Figure 4 Schematic diagram of the separation of the anchoring component and the anchoring device in

[0026] Figure 19 Schematic diagram of the structure of the stop provided by an embodiment of the present application.

[0027] Figure 20 Schematic diagram of the structure of the wire take-up device provided by an embodiment of the present application.

[0028] Figure 21 It is Figure 20 Axial sectional view of the connection between the wire take-up device and the adjusting device in

[0029] Figure 22 It is Figure 20 Schematic diagram of the structure of the wire take-up device with the proximal part of its housing removed in

[0030] Figure 23 It is Figure 20Schematic diagram of a partial structure of the wire reel in

[0031] Figure 24 is Figure 20 Schematic diagram of the wire reel in applied to mitral annuloplasty.

[0032] Figure 25 is Figure 20 Schematic diagram of the wire reel in applied to tricuspid annuloplasty.

[0033] Figure 26 Schematic diagram of the pusher rod pushing the spacer.

[0034] Figure 27 Schematic diagram of the path of the guiding sheath tube provided in an embodiment of the present application reaching near the mitral annulus.

[0035] Figures 28 - 31 Schematic diagram of the process of implanting the anchoring component on the annulus by the transcatheter annuloplasty system provided in an embodiment of the present application.

[0036] Figure 32 Schematic diagram of the path of the guiding sheath tube provided in an embodiment of the present application reaching near the tricuspid annulus.

[0037] The following specific embodiments will further illustrate the present application in conjunction with the above-mentioned drawings. Specific Embodiments

[0038] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, 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 application without creative efforts shall fall within the scope of protection of the present application.

[0039] In addition, the descriptions of the following embodiments refer to the attached drawings, which are used to illustrate specific embodiments in which the present application can be implemented. The directional terms mentioned in the present application, for example, "up", "down", "front", "rear", "left", "right", "inside", "outside", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer illustration and understanding of the present application, 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 thus cannot be construed as a limitation to the present application.

[0040] It should be noted that the defined terms "proximal end" and "distal end" described in the specification of this application are common terms in the field of interventional medicine. Specifically, the "distal end" refers to the end far from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation. The axial direction refers to the direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction. The central axis of the instrument or component refers to the straight line located at the center of the instrument or component and around which the instrument or component can rotate, or the straight line approximately located at the center of the instrument or component and around which the instrument or component can rotate. The instrument or component can be an axisymmetric object or a non-axisymmetric object.

[0041] It is worth noting that regardless of the "end" appearing in words such as "proximal end", "distal end", "one end", "the other end", "the first end", "the second end", "the initial end", "the terminal end", "both ends", "the free end", "the upper end", "the lower end", etc., it is not limited to the end head, endpoint or end face, but also includes the part that extends an axial distance and / or a radial distance on the component to which the end head, endpoint or end face belongs from the end head, endpoint or end face. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those commonly understood by those skilled in the technical field to which this application belongs. The common terms used in the specification of this application are only for the purpose of describing specific embodiments and should not be construed as a limitation of this application.

[0042] Please refer to Figures 1 - 5 , this application provides a transcatheter annuloplasty system, which can be used to implant a plurality of anchoring components 10 connected in series by a tightening wire 20 in cardiac tissues such as the mitral valve annulus or the tricuspid valve annulus. By tightening the tightening wire 20, the distance between the plurality of anchoring components 10 is reduced to directly reduce the annulus, thereby achieving the treatment of mitral regurgitation or tricuspid regurgitation.

[0043] In this application, the transcatheter annuloplasty system includes an implant 100, an anchoring device 200, and a delivery device 300. The implant 100 includes a plurality of anchoring components 10 and a tightening wire 20, and the plurality of anchoring components 10 are connected by the tightening wire 20. The anchoring component 10 includes an anchor 12 and a threading structure 14 rotatably sleeved on the anchor 12. The anchor 12 is used to anchor into cardiac tissues such as the mitral valve annulus and the tricuspid valve annulus, and the threading structure 14 is used to connect the tightening wire 20. Among them, after the plurality of anchoring components 10 are arranged along the circumferential direction of the cardiac tissue, the tightening wire 20 connects the threading structures 14 of the plurality of anchoring components 10, and the tightening wire 20 is located on the same side of the plurality of anchors 12 anchored into the cardiac tissue. Hereinafter, the cardiac tissue is taken as an example of the annulus for description.

[0044] It can be understood that to adapt to the structure of the annulus, multiple anchoring components 10 are sequentially implanted along the circumferential direction of the annulus and connected in series by a tightening wire 20, and the implant 100 is substantially C-shaped. Of course, the implant 100 can also be substantially D-shaped or circular. When all the anchoring components 10 are implanted in the annulus and the tightening wire 20 is tightened to reduce the distance between the anchoring components 10 to complete the annulus reduction, the middle anchoring components 10 (except for the two anchoring components 10 at the head and tail) are subjected to the resultant force of the tensile forces applied by the tightening wires 20 on both sides. As Figure 2 and Figure 6 shown, assuming that the tension on the tightening wire 20 after annulus reduction is the force F that keeps the annulus in a certain contracted state, and ignoring the frictional resistance, the resultant force f received by each middle anchoring component 10 is 2cos(A / 2)*F, where A is the included angle of the tensile forces applied by the tightening wires 20 on both sides received by the anchoring component 10. Since A is greater than 0° and less than 180°, when the included angle A of the tensile forces on both sides received by a certain middle anchoring component 10 is larger, the resultant force f received by the anchoring component 10 is smaller. When the tightening wire 20 is on the same side of the multiple anchors 12 anchored into the annulus, the included angle A of the tensile forces on both sides received by each middle anchoring component 10 is relatively large, and the resultant force f received is relatively small. And when there is a middle anchoring component 10, the tightening wire 20 of the adjacent anchoring component 10 is inside the anchor 12, while the tightening wire 20 of this anchoring component 10 is outside the anchor 12, the included angle A of the tensile forces on both sides received by this anchoring component 10 will be smaller, and the resultant force f received will be larger.

[0045] Therefore, after multiple anchoring components 10 are arranged along the circumferential direction of the annulus (i.e., the heart tissue), and the tightening wire 20 is on the same side of the multiple anchors 12 anchored into the annulus, it can be ensured that after the annulus reduction is completed, the middle anchoring components 10 are less stressed and the stress is more uniform, avoiding the situation where the anchoring components 10 are stressed too much, reducing the risk of the anchoring components 10 falling off, and making the implantation safer; at the same time, reducing the force of the anchoring components 10 on the valve, reducing the risk of damage to the valve. In addition, when the tightening wire 20 is tightened to perform annulus reduction, the tightening wire 20 moves stably and smoothly, ensuring the stability of the annulus reduction and good annulus reduction effect. The implant 100 of the present application reduces the risk of falling off.

[0046] In Figure 1 and Figure 2 the example, the tightening wire 20 is inside the multiple anchors 12 anchored into the annulus. In Figure 3In the example, the tightening wire 20 is located outside the plurality of anchors 12 anchored to the annulus. It should be noted that under the same annulus shrinking effect, when the tightening wire 20 is located inside the plurality of anchors 12 anchored to the annulus, that is, the tightening wire 20 is in a position closer to the valve orifice, the distance between the threading structures 14 is smaller, the implant 100 is more compact, which can accelerate the endothelialization of the whole implant 100 and reduce the risk in the later stage of the operation.

[0047] Please refer to Figure 5 , the delivery device 300 includes a delivery sheath 310 for delivering the anchor assembly 10 to the annulus (i.e., the heart tissue). Among them, a through groove 312 extending from the distal end portion towards the proximal end is formed in the tube wall of the delivery sheath 310. The through groove 312 communicates with the inner cavity of the delivery sheath 310, and the distal end of the through groove 312 has an opening. A clamping end 140 is provided on the threading structure 14 of the anchor assembly 10. When the anchor 12 is movably inserted into the inner cavity of the delivery sheath 310, the clamping end 140 can axially move and be located in the through groove 312. In this way, due to the restriction of the through groove 312 on the clamping end 140, the threading structure 14 and the delivery sheath 310 are relatively stopped from rotating, and the threading structure 14 is rotatably sleeved on the anchor 12. Rotating the delivery sheath 310 can drive the threading structure 14 to rotate 360° relative to the anchor 12. When positioning each anchor assembly 10 on the annulus, control the orientation of the through groove 312 at the distal end of the delivery sheath 310 so that the threading part of the threading structure 14 is on the same side of the plurality of anchors 12 anchored to the annulus, and then drive the anchors 12 to be anchored into the annulus, so as to control the tightening wire 20 to be on the same side of the plurality of anchors 12 anchored to the annulus. Please refer to Figure 7 and Figure 8 , rotating the delivery sheath 310 so that the through groove 312 at the distal end of the delivery sheath 310 faces the valve orifice of the annulus can make the tightening wire 20 located inside the plurality of anchors 12 anchored to the annulus; rotating the delivery sheath 310 so that the through groove 312 at the distal end of the delivery sheath 310 faces away from the valve orifice can make the tightening wire 20 located outside the plurality of anchors 12 anchored to the annulus. Preferably, the radial width of the clamping end 140 is adapted to the radial width of the through groove 312, which can prevent the threading structure 14 from shaking relative to the delivery sheath 310.

[0048] Further, a developing region is provided along the axial direction of the through groove 312 of the delivery sheath 310 or at the clamping end 140. In this way, during the operation, the developing region along the axial direction of the through groove 312 of the delivery sheath 310 or the developing region of the clamping end 140 can be observed through a digital subtraction angiography (DSA) device or other developing devices, so as to determine the orientation of the through groove 312 at the distal end of the delivery sheath 310. The delivery sheath 310 can be coated with a medical developing material on the tube wall at the axial position along the through groove 312 to form a developing region. Similarly, the clamping end 140 can be coated with a medical developing material to form a developing region, or the clamping end 140 is made of a developable material.

[0049] Please refer to Figure 4 , in some embodiments, the anchoring member 12 is detachably connected to the distal end of the anchoring device 200 and is inserted into the inner cavity of the delivery sheath 310. The anchoring device 200 is used to drive the anchoring member 12 to anchor into the valve annulus (i.e., heart tissue). When the distal end surface of the delivery sheath 310 abuts against the valve annulus, the anchoring device 200 drives the anchoring member 12 to rotate so that the anchoring member 12 extends out from the distal end of the delivery sheath 310 and anchors into the valve annulus. Due to the restriction of the through groove 312 of the delivery sheath 310 on the clamping end 140, the threading structure 14 will not rotate following the anchoring member 12, and the threading structure moves relative to the delivery sheath 310 along with the through groove 312 and the anchoring member 12. In this way, even if the anchoring member 12 anchors into the valve annulus by rotating, it can be ensured that the threading part of the threading structure 14 of each anchoring assembly 10 is located on the same side of the plurality of anchoring members 12 that anchor into the valve annulus. Therefore, the tightening wire 20 can be controlled to be on the same side of the anchoring members 12 that anchor into the valve annulus.

[0050] Please refer to Figure 9 , in some embodiments, the transcatheter annuloplasty system further includes at least one guiding sheath 400 for establishing an intervention channel from outside the patient's body to the heart. The distal part of the delivery sheath 310 is flexible, and the delivery sheath 310 can deliver the anchoring assembly 10 to the heart through the guiding sheath 400. In some embodiments, the number of guiding sheaths 400 is two, namely a first guiding sheath and a second guiding sheath inserted into the first guiding sheath. The second guiding sheath can extend out from the distal end of the first guiding sheath and fit on the valve annulus. Preferably, both the first guiding sheath and the second guiding sheath are adjustable bending sheaths, so that it is better to adjust the bending angle and direction of their distal ends, and further facilitate adjusting the distal end of the guiding sheath 400 (especially the second guiding sheath) to an angle that fits the valve annulus. In other embodiments, only one adjustable bending guiding sheath 400 can also be used. The adjustable bending sheath is a commonly used guiding device in interventional surgery in the prior art and will not be elaborated here.

[0051] Please refer to Figure 10 andFigure 11 In some embodiments, the threading structure 14 includes a connecting member 142 and a threading loop 144. The connecting member 142 is provided with an assembly hole 1422 and a connecting hole 1424. The anchoring member 12 is rotatably disposed in the assembly hole 1422, and the threading loop 144 passes through the connecting hole 1424 and is movably connected to the connecting member 142. The threading loop 144 is used to connect the tightening wire 20.

[0052] It can be understood that the threading structure 14 is rotatably sleeved on the anchoring member 12 through the connecting member 142, and the connecting member 142 and the threading loop 144 can rotate relative to the anchoring member 12. The tightening wire 20 is connected to the anchoring member 12 through the threading loop 144, so as to connect a plurality of anchoring assemblies 10 anchored to the valve annulus in series. Specifically, the distal end of the tightening wire 20 is connected to the threading loop 144 of the first anchoring assembly 10 for anchoring into the valve annulus (i.e., the heart tissue), and the proximal end of the tightening wire 20 can slidably pass through the threading loops 144 of other anchoring assemblies 10 for anchoring into the valve annulus. In this embodiment, the connecting hole 1424 is disposed at the clamping end 140 of the connecting member 142. Therefore, by controlling the orientation of the through groove 312 at the distal end of the delivery sheath 310, the threading loop 144 (i.e., the threading part) can be located on the same side of the plurality of anchoring members 12 anchored to the valve annulus, that is, the tightening wire 20 can be controlled to be located on the same side of the plurality of anchoring members 12 anchored to the valve annulus.

[0053] Please refer to Figure 12 In one example, the distal end of the tightening wire 20 is connected to the threading loop 144 of the first anchoring assembly 10 for anchoring into the valve annulus through a crimp tube 22. Specifically, after the tightening wire 20 passes through the threading loop 144, it is folded in half, and the two free ends of the tightening wire 20 are fixed through the crimp tube 22, so that the distal end of the tightening wire 20 is connected to the threading loop 144. Among them, the crimp tube 22 can be made of a metal material with good biocompatibility (such as but not limited to stainless steel), and is extruded by a press to fix the two free ends of the tightening wire 20. Preferably, the entire crimp tube 22 is wrapped with a film to reduce the risk of damage to the valve annulus and other heart tissues by the crimp tube 22.

[0054] Please refer to Figure 10, the threading loop 144 has a first rotation axis M perpendicular to the central axis X of the anchor 12. The first rotation axis M is coaxial or parallel to the central axis of the connection hole 1424. The threading loop 144 rotates around the first rotation axis M to approach or move away from the anchor 12. It can be understood that when the anchoring assembly 10 is inserted into the delivery sheath 310, the anchor 12 is located in the inner cavity of the delivery sheath 310. The connecting member 142 passes through the through slot 312 so that its locking end 140 is located in the through slot 312, and the threading loop 144 is located outside the delivery sheath 310. Since the threading loop 144 is located outside the delivery sheath 310, the threading loop 144 can rotate around the first rotation axis M to approach the anchor 12, and the threading loop 144 can closely adhere to the tube wall of the delivery sheath 310 to reduce the radial dimension, so that when the delivery sheath 310 delivers the anchoring assembly 10 through the guiding sheath 400, it can pass quickly and smoothly. In addition, the installation method of the anchoring assembly 10 enables the use of a delivery sheath 310 with a smaller pipe diameter, and thus a guiding sheath 400 with a smaller pipe diameter can be used. In the illustrated example, the first rotation axis M of the threading loop 144 is coaxial with the central axis Y of the connection hole 1424.

[0055] Please refer to Figure 13 , the threading loop 144 has a reference plane α, and the reference plane α is parallel or coincident with the plane where the assembly hole 1422 is located (i.e., the plane perpendicular to the central axis Z of the assembly hole 1422). The maximum angle by which the threading loop 144 rotates around the first rotation axis M from the reference plane α is greater than or equal to 90°. In this way, the radial dimension during the delivery of the anchoring assembly 10 can be minimized to the greatest extent. Preferably, the maximum angle by which the threading loop 144 rotates around the first rotation axis M from the reference plane α is greater than 90°. It can be understood that the angle by which the threading loop 144 can rotate clockwise around the first rotation axis M from the reference plane α is greater than 90° until it contacts the anchor 12 or the delivery sheath 310; the angle by which the threading loop 144 can rotate counterclockwise around the first rotation axis M from the reference plane α is greater than 90° until the threading loop 144 contacts the anchor 12 or the delivery sheath 310.

[0056] Further, please refer to Figures 1 - 3 , Figure 14 and Figure 15, the threading loop 144 further has a second rotation axis N, and the second rotation axis N is perpendicular to both the central axis X of the anchor 12 and the central axis Y of the connection hole 1424. The threading loop 144 rotates around the second rotation axis N to tilt the plane where the threading loop 144 is located (i.e., the plane perpendicular to the central axis of the threading loop 144) relative to the plane where the fitting hole 1422 is located (i.e., the plane perpendicular to the central axis Z of the fitting hole 1422). In this way, when the anchor 12 is successively anchored into the valve annulus, the anchor assemblies 10 are connected by the tightening wire 20. At this time, the threading loop 144 will rotate a certain angle around the second rotation axis N, causing the threading loop 144 to tilt relative to the plane where the tightening wire 20 is located (i.e., the reference plane α), reducing the friction between the threading loop 144 and the tightening wire 20, and ensuring that when the tightening wire 20 is tightened, the tightening wire 20 can smoothly move through the threading loop 144.

[0057] Specifically, the maximum angle range for the threading loop 144 to rotate around the second rotation axis N from the reference plane α is 30° to 45°. It can be understood that the maximum angle for the threading loop 144 to rotate around the second rotation axis N from the reference plane α can be 30°, 45°, or any degree between 30° and 45°. In one example, the maximum angle for the threading loop 144 to rotate clockwise around the second rotation axis N from the reference plane α is 40°, and the maximum angle for the threading loop 144 to rotate counterclockwise around the second rotation axis N from the reference plane α is 40°. The maximum angle for the threading loop 144 to rotate around the second rotation axis N from the reference plane α is positively correlated with the size of the gap between the connection hole 1424 and the threading loop 144.

[0058] In some embodiments, the threading loop 144 can be a circular ring or an elliptical ring, and the shape of its axial cross-section can also be circular or elliptical. The fitting hole 1422 and the connection hole 1424 of the connector 142 can be circular holes or elliptical holes. In some examples, the threading loop 144 is a circular ring and the shape of its axial cross-section is also circular; both the fitting hole 1422 and the connection hole 1424 of the connector 142 are circular holes. In other embodiments, the threading loop 144 can be an irregular ring structure, and the fitting hole 1422 and the connection hole 1424 of the connector 142 can also be holes with irregular shapes.

[0059] Please refer to Figure 16 and Figure 17, in other embodiments, the threading structure 14 includes a connecting member 142. The connecting member 142 is provided with an assembly hole 1422 and a threading hole 1426. The anchoring member 12 is rotatably disposed in the assembly hole 1422, and the threading hole 1426 is used to connect the tightening wire 20. It can be understood that the threading structure 14 is rotatably sleeved on the anchoring member 12 through the connecting member 142, and the connecting member 142 and the anchoring member 12 can rotate relative to each other. The tightening wire 20 is connected to the anchoring member 12 through the threading hole 1426 of the connecting member 142, thereby connecting a plurality of anchoring assemblies 10 anchored to the valve annulus in series. Specifically, the distal end of the tightening wire 20 is connected to the threading hole 1426 of the connecting member 142 of the first anchoring assembly 10 for anchoring into the valve annulus (i.e., heart tissue), and the proximal end of the tightening wire 20 can slide through the threading holes 1426 of the connecting members 142 of other anchoring assemblies 10 for anchoring into the valve annulus. In this embodiment, the threading hole 1426 is disposed at the clamping end 140 of the connecting member 142. Therefore, by controlling the orientation of the through slot 312 at the distal end of the delivery sheath 310, the threading hole 1426 (i.e., the threading part) can be located on the same side of a plurality of anchoring members 12 anchored to the valve annulus, that is, the tightening wire 20 can be controlled to be on the same side of a plurality of anchoring members 12 anchored to the valve annulus.

[0060] Please refer to Figure 10 , Figure 11 , Figure 16 and Figure 17 , in some embodiments, the anchoring member 12 includes an anchoring portion 122 and an anchoring seat 124 connected to the proximal end of the anchoring portion 122. The anchoring portion 122 is used for anchoring into the valve annulus (i.e., heart tissue), and the anchoring seat 124 is rotatably disposed in the assembly hole 1422 of the connecting member 142. Specifically, the anchoring seat 124 includes a seat body 1242, a support block 1244, and a support portion 1246 located between the seat body 1242 and the support block 1244. The seat body 1242, the support portion 1246, and the support block 1244 form a connection groove, and the connecting member 142 is rotatably sleeved on the support portion 1246, and the connecting member 142 is at least partially received in the connection groove. It can be understood that the aperture of the assembly hole 1422 is larger than the radial dimension of the support portion 1246 and smaller than the radial dimensions of the seat body 1242 and the support block 1244, so that the connecting member 142 can be rotatably sleeved on the anchoring seat 124 and will not fall off. In this way, the connecting member 142 can rotate 360° around the central axis of the anchoring member 12.

[0061] Furthermore, the connecting member 142 can also move axially on the support portion 1246 of the anchoring member 12. When the anchoring depths of the anchoring members 12 of a plurality of anchoring assemblies 10 are inconsistent, the tightening wire 20 can pull the connecting member 142 to move axially up and down, further reducing the bending of the tightening wire 20, and the tightening wire 20 is distributed as much as possible in the same plane to ensure the stable and smooth movement of the tightening wire 20.

[0062] Please refer to Figure 11 andFigure 17 In some embodiments, the anchor seat 124 further includes a plug-in portion 1248 connected to the distal end of the support portion 1246, the support block 1244 is fixed to the proximal end of the plug-in portion 1248 and abuts against the distal end surface of the support portion 1246, and the plug-in portion 1248 passes through the support block 1244 and is connected to the proximal end of the anchor portion 122. Specifically, the plug-in portion 1248 is provided with a plug-in hole extending along the axial direction of the anchor 12, and the proximal end of the anchor portion 122 is plugged into the plug-in hole and fixed by welding or gluing. Of course, the anchor portion 122 can also be directly fixedly connected to the distal end surface of the support block 1244 by welding or other means, and the support block 1244 is directly fixedly connected to the distal end surface of the support portion 1246, so that the plug-in portion 1248 does not need to be provided.

[0063] In the illustrated example, the anchoring portion 122 is a spiral anchor with a pointed end, which is easy to anchor into the heart tissue such as the valve ring, and the anchoring assembly 10 is not easy to fall off after implantation. Of course, the anchoring portion 122 can be another suitable structure that enables the anchoring portion 122 to engage with the tissue and be substantially fixed to the tissue, such as but not limited to barbs, hooks, sharp teeth, etc., and in order to facilitate delivery, the barbs and hooks are at least partially made of a material with shape memory function.

[0064] It should be noted that, in order to ensure safety after implantation, the anchoring component 10 is made of a material with good biocompatibility, including but not limited to metal materials, such as stainless steel; or polymer materials, such as polyether ether ketone (PEEK) and polyethylene terephthalate (PET).

[0065] See also Figure 4 and Figure 18 , the anchoring member 12 of the anchoring assembly 10 is detachably connected to the distal end of the anchoring device 200. In some embodiments, the anchoring device 200 includes a driving tube 210 and a connecting rod 220 inserted into the driving tube 210. The distal end of the driving tube 210 is provided with a connecting portion 212 detachably connected to the seat body 1242 of the anchoring seat 124, and the connecting rod 220 is axially inserted into the connecting portion 212 and the seat body 1242 that are connected in a matching manner so that the anchoring assembly 10 and the anchoring device 200 remain connected, and the driving tube 210 is used to drive the anchoring member 12 to anchor into the valve ring.

[0066] The proximal end of the seat body 1242 is an S-shaped buckle, and the connecting portion 212 is another corresponding S-shaped buckle. Both the seat body 1242 and the connecting portion 212 have an inner cavity. Figure 18As shown, when the connecting portion 212 and the seat body 1242 are butted, the two S-shaped buckles are buckled, and their inner cavities are communicated. The distal end of the connecting rod 220 installed in the driving tube 210 extends out from the distal end of the driving tube 210 and is inserted into the inner cavities of the connecting portion 212 and the seat body 1242, thereby restricting the separation of the connecting portion 212 and the seat body 1242, so that the anchoring assembly 10 remains connected to the driving tube 210. By rotating the driving tube 210, the anchoring member 12 can be driven to rotate, so that the anchoring portion 122 is anchored into the valve annulus. It can be understood that when the distal end of the connecting rod 220 withdraws from the butting and buckling portion of the seat body 1242 and the connecting portion 212, the seat body 1242 and the connecting portion 212 can be separated, thereby realizing the separation of the anchoring assembly 10 and the driving tube 210. The anchoring device 200 can be made of a metal material or a polymer material, preferably a metal material with a higher hardness such as stainless steel.

[0067] In other embodiments, the seat body 1242 and the connecting portion 212 can be a matching structure of a clamping block and a clamping groove. The anchoring device 200 can also be composed of the driving tube 210 and a connecting tube sleeved outside the driving tube 210. The distal end of the connecting tube is sleeved outside the cooperatively connected connecting portion 212 and the seat body 1242, and can also play a role in restricting the separation of the connecting portion 212 and the seat body 1242.

[0068] Please refer to again Figure 5 , in some embodiments, the delivery device 300 further includes a stop portion 320. The stop portion 320 is movably disposed at the distal end of the delivery sheath 310, and the stop portion 320 is used to close the opening of the through groove 312. It can be understood that the stop portion 320 can be moved to open or close the opening of the through groove 312, which is convenient for installing the anchoring assembly 10 or connecting the tightening wire 20. When the anchoring assembly 10 is installed in the delivery sheath 310 and the tightening wire 20 is connected, the anchoring member 12 of the anchoring assembly 10 is received in the inner cavity of the delivery sheath 310, and the distal end of the anchoring member 12 is separated from the tightening wire 20 by the stop portion 320, so that the portion of the tightening wire 20 extending distally from the connection point with the wire threading structure 14 (wire threading loop 144 or wire threading hole 1426) of the anchoring assembly 10 is located outside the delivery sheath 310, thereby preventing the tightening wire 20 from being wound around the anchoring member 12, avoiding the risk of wire winding, and being beneficial to the smooth implantation of the anchoring assembly 10. The portion of the tightening wire 20 extending proximally from the connection point with the wire threading structure 14 can be located in the inner cavity of the delivery sheath 310 or outside the delivery sheath 310.

[0069] In a preferred embodiment of the present application, the anchor 12 is located in the inner cavity of the delivery sheath 310. The clamping end 140 of the connecting member 142 is axially movable and located in the through slot 312, and the other parts of the connecting member 142 are located in the inner cavity of the delivery sheath 310. The threading loop 144 or the threading hole 1426 is located outside the delivery sheath 310; the tightening wire 20 is connected to the threading loop 144 or the threading hole 1426, and the tightening wire 20 is entirely located outside the delivery sheath 310. When the anchoring assembly 10 is inserted into the delivery sheath 310, first, the stop portion 320 is controlled to open the opening of the through slot 312; then, the anchor 12 is inserted into the inner cavity of the delivery sheath 310, and the clamping end 140 of the connecting member 142 slides into the through slot 312 from the opening as the anchor 12 moves, and the threading loop 144 or the threading hole 1426 is located outside the delivery sheath 310 to connect the tightening wire 20; then, the stop portion 320 is controlled to close the opening of the through slot 312, so that the stop portion 320 can separate the anchor 12 from the tightening wire 20.

[0070] Optionally, the proximal end of the through slot 312 may be closed or may extend axially through the proximal end of the delivery sheath 310. Preferably, the proximal end of the through slot 312 is closed, and the through slot 312 does not penetrate the opposite ends of the delivery sheath 310, and the structural strength of the delivery sheath 310 is high. Please refer to Figure 15 , the axial length of the through slot 312 is greater than the axial distance H between the proximal end of the connecting member 142 and the distal end of the anchoring portion 122, so that the entire anchor 12 can be received in the inner cavity of the delivery sheath 310, and the anchor 12 and the tightening wire 20 are completely isolated on the inner and outer sides of the delivery sheath 310, which is more conducive to avoiding the problem of wire winding during the delivery and implantation of the anchoring assembly 10.

[0071] In some embodiments, a chamfer or a rounded corner is provided at the opening of the through slot 312, so that the opening of the through slot 312 is flared. It can be understood that during the process of inserting the anchoring assembly 10 into the delivery sheath 310, a flared opening is more conducive to the clamping end 140 of the connecting member 142 entering the through slot 312, thus facilitating the assembly of the anchoring assembly 10.

[0072] Please refer to Figure 19, in some embodiments, the proximal end of the stop portion 320 extends along the axial direction of the delivery sheath 310, and the distal end of the stop portion 320 is adapted to the circumferential direction of the delivery sheath 310 and closes the opening of the through slot 312 when not subjected to external force. It can be understood that the stop portion 320 is an elongated member, and at least the distal portion of the stop portion 320 is made of a material with shape memory function (such as but not limited to nickel-titanium, nickel-titanium alloy, etc.). That is to say, the distal end of the stop portion 320 is made of a material with shape memory function, or the whole stop portion 320 is made of a material with shape memory function. Preferably, the distal end of the stop portion 320 is a non-closed loop in the natural state, so that the stop portion 320 has good guiding property and is easy to retract, which can increase the moving stroke of the stop portion 320, ensure that the distal end of the stop portion 320 can cross the through slot 312 to form a blocking effect, the opening of the through slot 312 is firmly and stably closed, and it can ensure that the stop portion 320 has sufficient strength and is not easy to break. Of course, the distal end of the stop portion 320 can also be an arc section adapted to the circumferential direction of the delivery sheath 310 in the natural state. It should be noted that the natural state refers to that the stop portion 320 is not subjected to any external force.

[0073] In a feasible embodiment, the stop portion 320 can be a stop wire, and the stop wire can be made of nickel-titanium wire, and its distal end forms a non-closed loop through heat setting treatment. The distal end of the delivery sheath 310 is provided with a stop wire channel 314 along the circumferential direction, the distal end of the stop wire is movably inserted into the stop wire channel 314, and the proximal end of the stop wire extends axially movably in the tube wall or the inner cavity of the delivery sheath 310. It can be understood that the distal end of the stop wire closes the opening of the through slot 312 when not subjected to external force. Due to the stop of the stop wire, the connecting member 142 of the anchoring assembly 10 cannot slide out from the opening of the through slot 312, so as to prevent the anchoring assembly 10 from detaching from the delivery sheath 310 during the delivery process, so as to ensure that the anchoring member 12 of the anchoring assembly 10 is always in the inner cavity of the delivery sheath 310 during the delivery process, and avoid the tightening wire 20 from being wound around the anchoring member 12.

[0074] In the above embodiment, the distance that the stop wire can be pulled and moved needs to be greater than the radial width of the through slot 312, so that the opening of the through slot 312 can be completely opened, so as not to prevent the connecting member 142 of the anchoring assembly 10 from sliding out of the through slot 312. The radial cross-sectional shape of the stop wire can be circular, oblate, rectangular, square or other shapes, etc., and the present application does not make specific limitations in this regard. In some examples, the radial cross-sectional shape of the stop wire is circular. In order to avoid the stop wire from breaking when being pulled, the diameter of the stop wire cannot be too small, and the diameter range of the stop wire can be 0.2 mm to 0.8 mm.

[0075] Please refer to again Figures 1 - 3, in some embodiments, the implant 100 further includes at least one spacer 30. The spacer 30 is mounted on the tightening wire 20, and the spacer 30 is located between two adjacent anchoring components 10. It can be understood that the spacer 30 can prevent the tightening wire 20 from being overly tightened, resulting in too short a distance between two adjacent anchoring components 10 and damaging the annulus. At the same time, the spacer 30 can play a buffering role, dispersing the tightening force received by the anchoring components 10 and ensuring the stable implantation of the anchoring components 10. Among them, the spacer 30 is a cylindrical member with a certain length, preferably made of a biocompatible material. The spacer 30 can be wrapped with a film to reduce the risk of the annulus and other cardiac tissues being damaged by the spacer 30.

[0076] Optionally, a spacer 30 can be provided between any two adjacent anchoring components 10 among the multiple anchoring components 10 of the implant 100, or a spacer 30 can be provided every two or more than two anchoring components 10, and this is not limited.

[0077] Please refer to Figures 1 - 3 and Figures 20 - 25 , in some embodiments, the implant 100 further includes a wire winder 40. The wire winder 40 includes a housing 42 and a winding shaft 44 rotatably disposed within the housing 42. The proximal end of the tightening wire 20 movably passes through the housing 42 and the winding shaft 44. The winding shaft 44 rotates relative to the housing 42 to wind the tightening wire 20. When the winding shaft 44 stops rotating, the tightening wire 20 is fixed within the radial space between the winding shaft 44 and the housing 42.

[0078] It can be understood that by controlling the rotation of the winding shaft 44 relative to the housing 42, the tightening wire 20 can be wound, so that the tightening wire 20 is continuously tightened to reduce the distance between multiple anchoring components 10 and perform annulus reduction on the annulus. The rotation of the winding shaft 44 can be stopped until the blood reflux weakens or disappears. At this time, the tightening wire 20 is fixed within the radial space between the winding shaft 44 and the housing 42, and the tightening wire 20 maintains a certain length on the annulus. By winding and locking the tightening wire 20 with the wire winder 40, the locking effect of the tightening wire 20 is good. Moreover, if after a period of time, the patient's annulus expands again and the reflux recurs, the wire winder 40 can be directly controlled to further wind the tightening wire 20 to reduce the annulus so that the reflux weakens or disappears, avoiding causing greater harm to the patient during a second operation. The wire winder 40 can be made of a biocompatible material, such as stainless steel, and this is not limited.

[0079] It should be noted that the tightening wire 20 is wound around the winding shaft 44 for at least three turns, and the friction force between each turn of the tightening wire 20 can offset the pulling force generated by the movement of the valve leaf, ensuring that the tightening wire 20 is not pulled and the tightening wire 20 maintains a certain length on the annulus.

[0080] Specifically, the housing 42 includes a bottom case 422 and an outer shell 424. Both the proximal end and the distal end of the outer shell 424 have openings, and the bottom case 422 is fixedly connected to the distal end of the outer shell 424 to form an installation space. The wire winder 40 further includes a limit post 46, a stop wheel 48, and an elastic member 41. The limit post 46, the elastic member 41, the stop wheel 48, and the winding shaft 44 are disposed in the installation space of the housing 42.

[0081] As Figure 22 shown, the winding shaft 44 is provided with a winding hole 442 along its radial direction, and the outer shell 424 is provided with wire passing holes 426 on both sides of the winding shaft 44. Both of the two wire passing holes 426 communicate with the winding hole 442 of the winding shaft 44. When the wire winder 40 is mounted on the tightening wire 20, the tightening wire 20 first penetrates into the installation space of the housing 42 through one wire passing hole 426, then passes through the winding hole 442 of the winding shaft 44, and then penetrates out of the housing 42 through the other wire passing hole 426. Preferably, the central axes of the two wire passing holes 426 and the central axis of the winding hole 442 are in the same plane. The winding shaft 44 can be rotated to align the central axis of the winding hole 442 with the central axes of the two wire passing holes 426, which is beneficial to the smooth passing of the tightening wire 20 through the two wire passing holes 426 and the winding hole 442.

[0082] As Figure 21 and Figure 23 shown, the distal end of the limit post 46 is fixedly connected to the bottom case 422. The stop wheel 48 is axially movably sleeved on the limit post 46 and is relatively non-rotatable with respect to the limit post 46. The elastic member 41 abuts between the bottom case 422 and the stop wheel 48. The winding shaft 44 is rotatably sleeved on the limit post 46. A plurality of first helical teeth 482 are provided along the circumferential direction at the proximal end of the stop wheel 48, and a plurality of second helical teeth 444 are provided along the circumferential direction at the distal end of the winding shaft 44. The second helical teeth 444 are in one-way rotational cooperation with the first helical teeth 482.

[0083] Specifically, a limiting boss 484 is further provided at the proximal end of the stop rotating wheel 48, and a limiting groove 428 is correspondingly provided at the distal end of the outer shell 424. The stop rotating wheel 48 is sleeved on the limiting column 46, and the limiting boss 484 is clamped in the corresponding limiting groove 428, so as to limit the rotation of the stop rotating wheel 48 relative to the limiting column 46, and the stop rotating wheel 48 can axially move along the limiting column 46. A groove (not marked in the figure) matching with the proximal end of the limiting column 46 is further provided on the distal end surface of the winding shaft 44. The proximal part of the limiting column 46 is received in the groove at the distal end of the winding shaft 44, and the proximal end surface of the limiting column 46 contacts the distal end surface of the winding shaft 44, so as to jointly limit the axial displacement of the winding shaft 44 in the installation space with the proximal end of the outer shell 424, so that the winding shaft 44 can only rotate. The elastic member 41 is located between the stop rotating wheel 48 and the bottom shell 422, one end of which abuts against the bottom shell 422, and the other end abuts against the stop rotating wheel 48. The elastic member 41 is used to provide an elastic force to the stop rotating wheel 48, so that the first helical tooth 482 of the stop rotating wheel 48 fits the second helical tooth 444 of the winding shaft 44. The elastic member 41 can be but is not limited to a spring, a tubular elastic sheet, an elastic corrugated pipe, etc.

[0084] When the winding shaft 44 rotates forward relative to the housing 42 and the stop rotating wheel 48, the second helical tooth 444 slips on the first helical tooth 482 to make the stop rotating wheel 48 move distally. When the winding shaft 44 rotates through an angle of one helical tooth relative to the stop rotating wheel 48, the stop rotating wheel 48 will move proximally after receiving the elastic force given by the elastic member 41, so that the first helical tooth 482 and the second helical tooth 444 are re-fitted, and the winding shaft 44 can continue to rotate relative to the housing 42 and the stop rotating wheel 48. When the winding shaft 44 needs to rotate reversely, due to the obstruction of the first helical tooth 482, the second helical tooth 444 cannot make the stop rotating wheel 48 move distally, resulting in the inability of the winding shaft 44 to rotate reversely. Therefore, when the winding shaft 44 stops rotating, the tightening wire 20 is fixed in the radial space between the winding shaft 44 and the housing 42. It should be noted that the radial space refers to the space surrounded by the winding shaft 44 and the outer shell 424, and the radial space is a part of the installation space.

[0085] In other embodiments, after implanting a plurality of anchoring components 10 and spacers 30 in the valve annulus, when the tightening wire 20 is pulled to reduce or eliminate blood reflux by reducing the ring, locking nails can be fed along the tightening wire 20 to lock the tightened tightening wire 20, so that the tightening wire 20 maintains the tightened state, and the redundant part of the tightening wire 20 can be cut and removed.

[0086] Please refer to again Figure 12, in some embodiments, the delivery device 300 further includes a delivery member 330. The distal end of the delivery member 330 is connected to the proximal end of the tightening wire 20, and the proximal end of the delivery member 330 extends outside the body. In this way, the anchoring assembly 10, the spacer 30, the wire reel 40, etc. can be threaded onto the tightening wire 20 through the delivery of the delivery member 330, so that the tightening wire 20 can select an appropriate implantation length, thus eliminating the need to cut the tightening wire 20 in the body, avoiding the shedding of particles on the wire, and making the annuloplasty surgery safer.

[0087] It should be noted that the distal end of the tightening wire 20 is connected to the first anchoring assembly 10 for anchoring into the valve annulus, and the other anchoring assemblies 10 for anchoring into the valve annulus are transported along the delivery member 330 and threaded onto the tightening wire 20. Similarly, the spacer 30 and the wire reel 40 are also transported along the delivery member 330 and threaded onto the tightening wire 20. Among them, the tightening wire 20 has a certain axial length and is flexible. The radial cross-sectional shape of the tightening wire 20 can be circular, oval, rectangular, square or other shapes, etc.; similarly, the delivery member 330 also has a certain axial length and is flexible, and the radial cross-sectional shape of the delivery member 330 can also be circular, oval, rectangular, square or other shapes, etc.; the present application does not specifically limit the radial cross-sectional shapes of the tightening wire 20 and the delivery member 330. The tightening wire 20 can be formed by braiding wires of imaging materials such as tungsten, nitinol, tantalum, gold and their alloys, etc., so as to facilitate observing the position of the tightening wire 20 in the heart with the assistance of a digital subtraction angiography device or other imaging devices.

[0088] In some embodiments, the proximal end of the tightening wire 20 is folded in half to form a U shape, and the delivery member 330 is a delivery wire. The delivery wire passes through the folded portion of the tightening wire 20 to achieve detachable connection. Of course, the delivery wire can also be non-detachably connected to the tightening wire 20, and the delivery wire is withdrawn from the body by cutting the delivery wire outside the body. In other embodiments, the delivery member 330 can also be detachably connected to the tightening wire 20 by means of threaded connection, snap connection, etc., which will not be elaborated here.

[0089] After implanting a plurality of anchoring assemblies 10 and spacers 30 in the valve annulus, the wire reel 40 is threaded onto the tightening wire 20 along the delivery member 330, and then the wire reel 40 is used to tighten the tightening wire 20 and fix the tightening wire 20 so that the tightening wire 20 maintains a certain length on the valve annulus. Then, the delivery member 330 can be withdrawn, the tightening wire 20 is released, and the annuloplasty is completed to reduce blood reflux. It can be understood that by using the delivery member 330, the wire reel 40 can be threaded onto the tightening wire 20 and the tightening wire 20 can be successfully released, without the need to implant the wire reel 40 into the patient's body in advance, simplifying the surgical process, reducing the surgical difficulty, and shortening the surgical time.

[0090] Please refer to Figure 26, in some embodiments, the transcatheter annulus reduction system further includes a push rod 500 for pushing the spacer 30. Specifically, a guiding hole 510 for the proximal end of the delivery member 330 to movably pass through is formed at the distal end of the push rod 500. After the spacer 30 is mounted on the delivery member 330, the delivery member 330 passes through the guiding hole 510 of the push rod 500, and the push rod 500 pushes the spacer 30 along the delivery member 330 into the guiding sheath 400. Then, the delivery sheath 310 is mounted in the guiding sheath 400 to push the spacer 30 in the guiding sheath 400, so that the spacer 30 is mounted on the tightening wire 20 along the delivery member 330.

[0091] It can be understood that after the first anchoring assembly 10 is implanted in the annulus, the delivery sheath 310 and the anchoring device 200 are withdrawn. After the spacer 30 is mounted on the proximal end of the delivery member 330 and the delivery member 330 passes through the guiding hole 510 of the push rod 500 in the direction a, the push rod 500 pushes the spacer 30 along the delivery member 330 into the guiding sheath 400 in the direction b. Then, the push rod 500 is removed, and the second anchoring assembly 10 mounted on the delivery sheath 310 is mounted on the delivery member 330 through its threading loop 144 exposed outside the delivery sheath 310. The delivery sheath 310 is further mounted in the guiding sheath 400, and the spacer 30 is located on the distal side of the delivery sheath 310. Thus, when the delivery sheath 310 moves axially distally in the guiding sheath 400, the spacer 30 and the second anchoring assembly 10 can be mounted on the tightening wire 20 along the delivery member 330, and the spacer 30 is pushed to the annulus. Then, the anchoring device 200 pushes the second anchoring assembly 10 out of the delivery sheath 310 and anchors the second anchoring assembly 10 into the annulus, so that the spacer 30 is located between the two anchoring assemblies 10. By repeating the same steps, multiple anchoring assemblies 10 are sequentially implanted into the annulus, and the spacer 30 is sequentially inserted between every two or more anchoring assemblies 10. Among them, the distance between the anchoring points of two adjacent anchoring assemblies 10 needs to be greater than the axial length of the spacer 30.

[0092] Please refer to again Figure 21, in some embodiments, the transcatheter annuloplasty system further includes an adjusting device 600. The wire reel 40 is detachably connected to the distal end of the adjusting device 600. The adjusting device 600 is used to drive the wire reel 40 to tighten the tightening wire 20. Specifically, the adjusting device 600 includes a threaded rod 610, a rotating tube 620, and an outer sheath tube 630 that are sleeved from the inside to the outside. In the wire reel 40, the proximal end of the wire winding shaft 44 extends out of the proximal opening of the housing 424, and a threaded hole 446 is provided along the axial direction of the proximal end of the wire winding shaft 44. Among them, the distal end of the outer sheath tube 630 is snap-connected to the housing 42 to limit the rotation of the housing 42; the distal end of the rotating tube 620 is sleeved on the proximal end of the wire winding shaft 44, and the rotating tube 620 is relatively non-rotatable with respect to the wire winding shaft 44; the threaded rod 610 is threadedly connected to the threaded hole 446 to maintain the connection between the rotating tube 620 and the wire winding shaft 44. Therefore, by rotating the rotating tube 620, the wire winding shaft 44 can be driven to rotate to wind the tightening wire 20 to tighten the tightening wire 20.

[0093] In some embodiments, the housing 424 of the housing 42 is provided with a card slot 421, and the distal end of the outer sheath tube 630 is provided with a claw 632 corresponding to the card slot 421. Through the cooperation of the claw 632 and the card slot 421, the outer sheath tube 630 is connected to the housing 42. A first boss 622 also protrudes from the outer wall of the rotating tube 620. After the claw 632 is snap-connected to the card slot 421 and the distal end of the rotating tube 620 is sleeved on the proximal end of the wire winding shaft 44, the first boss 622 can press the claw 632 against the housing 42 to limit the proximal movement of the outer sheath tube 630, so that the outer sheath tube 630 is kept connected to the housing 42. A second boss 624 also protrudes from the inner wall of the rotating tube 620, and a third boss 612 protrudes from the outer wall of the threaded rod 610. After the distal end of the rotating tube 620 is sleeved on the proximal end of the wire winding shaft 44 and the threaded rod 610 is screwed into the threaded hole 446, the third boss 612 can press the second boss 624 against the wire winding shaft 44 to limit the proximal movement of the rotating tube 620, so that the rotating tube 620 is kept connected to the wire winding shaft 44. At this time, the outer sheath tube 630 restricts the rotation of the housing 42. By rotating the rotating tube 620, the threaded rod 610 and the wire winding shaft 44 can be driven to rotate synchronously. Thus, the wire winding shaft 44 rotates relative to the housing 42 to wind the tightening wire 20 to tighten the tightening wire 20, realizing annuloplasty.

[0094] The following will be combined with Figure 1 , Figure 7 , Figure 24 , Figure 26 and Figures 27 - 31 , taking the application of the transcatheter annuloplasty system in mitral valve annuloplasty as an example to illustrate the use process and working principle of the transcatheter annuloplasty system according to the embodiments of the present application. Among them, the surgical path is: femoral vein - inferior vena cava - right atrium (RA) - atrial septum (AS) - left atrium (LA) - mitral valve (MV) annulus.

[0095] First step: Puncture the femoral vein, and establish a track from the femoral vein to the inferior vena cava, right atrium, atrial septum, left atrium, and mitral annulus through a guide wire (the guide wire and devices such as the atrial septum puncture device are not shown in the figure).

[0096] Second step: As Figure 27 shown, insert the guiding sheath 400 along the guide wire until its distal end passes through the foramen ovale to reach the left atrium and is sent near the mitral annulus, and then withdraw the guide wire.

[0097] Third step: As Figure 28 shown, the threading loop 144 of the first anchoring assembly 10 is connected to the distal end of the tightening wire 20, and the proximal end of the tightening wire 20 is detachably connected to the distal end of the delivery member 330. First, detachably connect the first anchoring assembly 10 to the anchoring device 200 and assemble it at the distal end of the delivery sheath 310, where the threading loop 144, tightening wire 20, and delivery member 330 of the first anchoring assembly 10 are located outside the delivery sheath 310; then, move the delivery sheath 310 axially distally in the guiding sheath 400 until its distal end abuts against the predetermined anchoring site on the mitral annulus. Among them, during the process of assembling the anchoring assembly 10 at the distal end of the delivery sheath 310, it is necessary to pull the stop wire (i.e., the stop portion 320) proximally to open the opening of the through slot 312, so that the connecting member 142 of the anchoring assembly 10 enters the through slot 312 and then release the stop wire, and the stop wire resets to close the opening of the through slot 312.

[0098] Fourth step: As Figure 29 and Figure 30 shown, under the ultrasound and digital subtraction angiography equipment, observe whether the through slot 312 of the delivery sheath 310 faces the valve orifice and whether the tightening wire 20 winds around the delivery sheath 310. If the through slot 312 of the delivery sheath 310 faces the valve orifice and the tightening wire 20 does not wind around the delivery sheath 310, at this time, use the anchoring device 200 installed in the inner cavity of the delivery sheath 310 to implant the first anchoring assembly 10 on the mitral annulus; then pull the stop wire to make the stop wire move proximally to open the opening of the through slot 312, and then withdraw the delivery sheath 310 proximally to completely separate the first anchoring assembly 10 from the delivery sheath 310, and release the connection between the anchoring device 200 and the first anchoring assembly 10.

[0099] Fifth step: As Figure 26As shown, after implanting the first anchoring component 10, the anchoring device 200 and the delivery sheath 310 are withdrawn, and the spacer 30 is introduced into the guiding sheath 400 through the delivery member 330. Then, the proximal end of the delivery member 330 passes through the threading loop 144 of the second anchoring component 10 (the second anchoring component 10 has been connected to the distal end of the anchoring device 200 and is threaded through the delivery sheath 310), and the delivery sheath 310 is pushed in the guiding sheath 400. By pushing the delivery sheath 310 forward, the first spacer 30 and the second anchoring component 10 are delivered along the delivery member 330 to be threaded onto the tightening wire 20 and delivered near the mitral valve annulus. The spacer 30 is located between the first anchoring component 10 and the second anchoring component 10. As Figure 31 shown, under the ultrasound and digital subtraction angiography equipment, according to the size of the diseased mitral valve annulus, the guiding sheath 400 and the delivery sheath 310 are controlled to adjust the position of the second anchoring component 10. After controlling the through slot 312 of the delivery sheath 310 to face the valve orifice, the second anchoring component 10 is implanted.

[0100] In the sixth step, repeat the fifth step. Sequentially implant the anchoring components 10 and the spacers 30 from the anterior trigone area of the mitral valve along the posterior valve annulus to the posterior trigone area or vice versa, so that the anchoring components 10 and the spacers 30 are evenly distributed on the mitral valve annulus (as Figure 7 shown). After implanting a sufficient number of anchoring components 10, the anchoring device 200 and the delivery sheath 310 are withdrawn.

[0101] In the seventh step, first pass the proximal end of the delivery member 330 through the wire take-up device 40 at the distal end of the adjusting device 600, and send the wire take-up device 40 along the delivery member 330 to the tightening wire 20 (as Figure 24 shown). Then, rotate the rotating tube 620 of the adjusting device 600 forward to make the winding shaft 44 of the wire take-up device 40 rotate to wind the tightening wire 20, thereby adjusting the length of the tightening wire 20 on the mitral valve annulus to reduce the distance between the multiple anchoring components 10, and further driving the contraction of the mitral valve annulus. After achieving a good annulus reduction effect, the rotating tube 620 stops rotating, the wire take-up device 40 locks the tightening wire 20, and then reverse the threaded rod 610 to disengage the wire take-up device 40 from the adjusting device 600 to facilitate the withdrawal of the adjusting device 600. The implant 100 remains on the mitral valve annulus (as Figure 1 shown, the tightening wire 20 is located inside the multiple anchor members 12 anchored to the mitral valve annulus), and the annulus reduction surgery is completed. Among them, when the winding shaft 44 of the wire take-up device 40 winds the tightening wire 20, it is necessary to avoid winding the connection between the delivery member 330 and the tightening wire 20 onto the winding shaft 44 to prevent the smooth withdrawal of the delivery member 330.

[0102] It can be understood that the transcatheter annulus reduction system provided in this application can also be applied to tricuspid valve annuloplasty. The following will be combined with Figure 2 、 Figure 8, Figure 25 , Figure 26 and Figures 28 - 32 , taking the application of the transcatheter annuloplasty system in tricuspid annuloplasty as an example to illustrate the usage process and working principle of the transcatheter annuloplasty system of the embodiment of the present application. Among them, the surgical path is: femoral vein - inferior vena cava - right atrium (RA) - annulus of tricuspid valve (TV).

[0103] The first step is to puncture the femoral vein, and establish an orbit of femoral vein - inferior vena cava - right atrium - annulus of tricuspid valve through a guide wire (the guide wire is not shown in the figure).

[0104] The second step is to, as Figure 32 shown, send the guiding sheath 400 along the guide wire until its distal end reaches the left atrium and is sent near the annulus of tricuspid valve, and then withdraw the guide wire.

[0105] The third step is to, as Figure 28 shown, connect the threading loop 144 of the first anchoring assembly 10 to the distal end of the tightening wire 20, and the proximal end of the tightening wire 20 is detachably connected to the distal end of the delivery member 330. First, detachably connect the first anchoring assembly 10 to the anchoring device 200 and assemble it at the distal end of the delivery sheath 310, wherein the threading loop 144, the tightening wire 20 and the delivery member 330 of the first anchoring assembly 10 are located outside the delivery sheath 310; then, move the delivery sheath 310 axially distally in the guiding sheath 400 until its distal end abuts against the predetermined anchoring point on the annulus of tricuspid valve. Among them, during the process of assembling the anchoring assembly 10 at the distal end of the delivery sheath 310, it is necessary to pull the stop wire (i.e., the stop portion 320) proximally to open the opening of the through slot 312, so that the connecting member 142 of the anchoring assembly 10 enters the through slot 312 and then release the stop wire, and the stop wire resets to close the opening of the through slot 312.

[0106] The fourth step is to, as Figure 29 and Figure 30 shown, under the ultrasonic and digital subtraction angiography equipment, observe whether the through slot 312 of the delivery sheath 310 faces the valve orifice and whether the tightening wire 20 winds around the delivery sheath 310. If the through slot 312 of the delivery sheath 310 faces the valve orifice and the tightening wire 20 does not wind around the delivery sheath 310, at this time, use the anchoring device 200 installed in the inner cavity of the delivery sheath 310 to implant the first anchoring assembly 10 on the annulus of tricuspid valve; then pull the stop wire, so that the stop wire moves proximally to open the opening of the through slot 312, and then withdraw the delivery sheath 310 proximally, so that the first anchoring assembly 10 is completely separated from the delivery sheath 310, and the connection between the anchoring device 200 and the first anchoring assembly 10 is released.

[0107] The fifth step is to, as Figure 26As shown, after implanting the first anchoring component 10, the anchoring device 200 and the delivery sheath 310 are withdrawn, and the spacer 30 is introduced into the guiding sheath 400 through the delivery member 330; then the proximal end of the delivery member 330 passes through the threading loop 144 of the second anchoring component 10 (the second anchoring component 10 has been connected to the distal end of the anchoring device 200 and is mounted on the delivery sheath 310), and the delivery sheath 310 is pushed in the guiding sheath 400. By pushing the delivery sheath 310 forward, the first spacer 30 and the second anchoring component 10 are conveyed along the delivery member 330 to be mounted on the tightening wire 20 and conveyed to near the tricuspid annulus. The spacer 30 is located between the first anchoring component 10 and the second anchoring component 10. As Figure 31 shown, under the ultrasound and digital subtraction angiography equipment, according to the size of the diseased tricuspid annulus, the guiding sheath 400 and the delivery sheath 310 are controlled to adjust the position of the second anchoring component 10. After controlling the through groove 312 of the delivery sheath 310 to face the valve orifice, the second anchoring component 10 is implanted.

[0108] Step 6: Repeat Step 5. Sequentially implant the anchoring components 10 and the spacers 30 from the anterior-septal commissure of the tricuspid valve along the anterior annulus, posterior annulus to the posterior-septal commissure or vice versa, so that the anchoring components 10 and the spacers 30 are evenly distributed on the tricuspid annulus (as Figure 8 shown). After implanting a sufficient number of anchoring components 10, the anchoring device 200 and the delivery sheath 310 are withdrawn.

[0109] Step 7: First, pass the proximal end of the delivery member 330 through the wire winder 40 at the distal end of the adjusting device 600, and send the wire winder 40 along the delivery member 330 to the tightening wire 20 (as Figure 25 shown); then, rotate the rotating tube 620 of the adjusting device 600 forward to make the winding shaft 44 of the wire winder 40 rotate to wind the tightening wire 20, thereby adjusting the length of the tightening wire 20 on the tricuspid annulus to reduce the distance between multiple anchoring components 10, and further driving the contraction of the tricuspid annulus. After achieving a good annulus contraction effect, the rotating tube 620 stops rotating, the wire winder 40 locks the tightening wire 20, and then the threaded rod 610 is rotated in the reverse direction to disengage the wire winder 40 from the adjusting device 600 so as to facilitate the withdrawal of the adjusting device 600, and the implant 100 is left on the tricuspid annulus (as Figure 2 shown, the tightening wire 20 is located inside the multiple anchoring components 10 anchored to the tricuspid annulus), and the annulus contraction surgery is completed.

[0110] It should be noted that during the implantation process of the anchoring component 10, there is a relatively low probability of wire pressing. At this time, the ultrasound and DSA equipment can be combined to reversely rotate the drive tube 210 of the anchoring device 200 to loosen the anchoring component 10, so that the tightening wire 20 can be disengaged, and then the anchoring component 10 is tightened again for implantation.

[0111] In addition, the transcatheter annuloplasty system provided by the present application can also be used to implant a plurality of anchoring components 10 connected in series by a tightening wire 20 into cardiac tissues such as the left ventricular wall or the right ventricular wall. By tightening the tightening wire 20, the distance between the plurality of anchoring components 10 is reduced, so as to reduce the volume of the ventricle by narrowing the ventricle to achieve the purpose of reducing the mitral annulus or the tricuspid annulus, thereby realizing the treatment of mitral regurgitation or tricuspid regurgitation. That is to say, in addition to being directly implanted on the annulus on the atrial side, the implant 100 can also be implanted under the annulus, that is, the implant 100 can also be implanted on the left ventricular wall under the mitral annulus or the right ventricular wall under the tricuspid annulus. Among them, implanting the implant 100 on the left ventricular wall is particularly suitable for treating heart failure caused by abnormal left ventricular function and functional mitral regurgitation. Specifically, the guiding sheath 400 can be punctured from the femoral artery and retrogradely enter the left ventricle through the aortic valve. The implant 100 is implanted on the left ventricular wall through the delivery device 300 and the anchoring device 200. After the tightening wire 20 is tightened, it directly inhibits the dilation of the left ventricle to achieve the purpose of reducing the mitral annulus. This subannular plasty can preserve the natural structure of the mitral valve. That is to say, the transcatheter annuloplasty system of the present application can be used not only to contract the annulus in annuloplasty, but also to reduce the ventricular volume in ventricular volume reduction surgery. The specific use process is basically similar to the use process of the above-mentioned mitral annuloplasty or tricuspid annuloplasty, and will not be elaborated here.

[0112] In summary, the transcatheter annuloplasty system of the present application can be used to anchor a plurality of anchoring components 10 connected in series by a tightening wire 20 on cardiac tissues such as the mitral annulus, the tricuspid annulus, the left ventricular wall, and the right ventricular wall. By tightening the tightening wire 20, the distance between the plurality of anchoring components 10 is reduced, thereby realizing the treatment of mitral regurgitation, tricuspid regurgitation, or heart failure caused by abnormal left ventricular function.

[0113] In the description of this specification, the descriptions with reference to terms such as "some embodiments", "schematic embodiments", "examples", "specific examples", or "some examples" mean that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples.

[0114] Although the embodiments of the present application have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and purposes of the present application. The scope of the present application is defined by the claims and their equivalents.

Claims

1. An implant for reducing the risk of detachment, characterized in that, The invention comprises a tightening line and a plurality of anchoring components, wherein the anchoring component comprises an anchor and a threading structure rotatably sleeved on the anchor, the anchor is used to be anchored into the heart tissue, and the threading structure is used to connect the tightening line; wherein after the plurality of anchoring components are arranged along the circumference direction of the heart tissue, the tightening line is connected to the threading structure, and the tightening line is located on the same side of the plurality of anchors anchored into the heart tissue; The threading structure comprises: A connecting piece, through which the threading structure is rotatably sleeved on the anchoring piece, and the connecting piece is provided with a connecting hole; and A threading ring passes through the connecting hole and is movably connected to the connecting member. The threading ring has a first rotation axis that is perpendicular to the central axis of the anchor member. The threading ring rotates around the first rotation axis to approach or move away from the anchor member.

2. The implant according to claim 1, characterized in that, The tightening wire is located inside the plurality of anchors anchored into the heart tissue.

3. The implant according to claim 1, characterized in that, The connecting piece is provided with an assembly hole, and the anchoring piece is rotatably inserted into the assembly hole.

4. The implant according to claim 3, characterized in that, The first rotation axis is coaxial with or parallel to the central axis of the connecting hole.

5. The implant according to claim 3 or 4, characterized in that, The threading ring also has a second rotation axis, which is perpendicular to the central axis of the anchor and the central axis of the connecting hole. The threading rotates around the second rotation axis to tilt the plane where the threading ring is located relative to the plane where the assembly hole is located.

6. The implant according to claim 3, characterized in that, The anchoring member comprises an anchoring portion and an anchoring seat connected to the proximal end of the anchoring portion, the anchoring portion is used to be anchored into the heart tissue, and the anchoring seat is rotatably inserted into the assembly hole.

7. The implant according to claim 6, characterized in that, The anchor seat includes a seat body, a support block and a support portion located between the seat body and the support block. The seat body, the support portion and the support block form a connecting groove. The connecting member is rotatably mounted on the support portion, and the connecting member is at least partially accommodated in the connecting groove.

8. The implant according to claim 1, wherein, The implant further comprises at least one spacer, which is threaded on the tightening wire and located between the two anchor components.

9. The implant according to claim 1 or 8, characterized in that, The implant also includes a wire reel, which includes a shell and a winding shaft rotatably disposed in the shell. The proximal end of the tightening wire movably passes through the shell and the winding shaft. The winding shaft rotates relative to the shell to wind the tightening wire. When the winding shaft stops rotating, the tightening wire is fixed in the radial space between the winding shaft and the shell.

10. The implant according to claim 1, wherein, The heart tissues include the mitral valve annulus, the tricuspid valve annulus, the left ventricular wall, and the right ventricular wall.

11. A transcatheter ring constriction system, characterized in that, A delivery device and the implant according to any one of claims 1 to 10, wherein the delivery device comprises a delivery sheath, and the delivery sheath is used to deliver the anchor assembly to the cardiac tissue; Among them, the tube wall of the delivery sheath is provided with a through groove extending from the distal end to the proximal end, the through groove is connected to the inner cavity of the delivery sheath, the distal end of the through groove has an opening, the threading structure is provided with a clamping end, and when the anchor is movably installed in the inner cavity of the delivery sheath, the clamping end can be axially moved in the through groove.

12. The transcatheter annuloplasty system according to claim 11, wherein, The radial width of the clamping end is adapted to the radial width of the through slot.

13. The transcatheter annuloplasty system according to claim 11 or 12, wherein The delivery sheath tube is provided with a radiopaque region along the axial direction of the through groove.

14. The transcatheter constricting ring system according to claim 11 or 12, wherein The clamping end is provided with a radiopaque region.

15. The transcatheter constricting ring system according to claim 11, wherein The delivery device further includes a stop portion, the stop portion is movably disposed at the distal end of the delivery sheath tube, and the stop portion is used to close the opening.

16. The transcatheter constricting ring system according to claim 15, wherein, The proximal end of the stop portion extends along the axial direction of the delivery sheath tube, and the distal end of the stop portion is configured to be circumferential to the delivery sheath tube and close the opening when not under external force.

17. The transcatheter constricting ring system according to claim 11, wherein The transcatheter annuloplasty system further includes an anchoring device, the anchor is detachably connected to the distal end of the anchoring device and is inserted into the inner cavity of the delivery sheath tube, and the anchoring device is used to drive the anchor to anchor into the heart tissue.

18. The transcatheter constricting ring system according to claim 11, wherein The delivery device further includes a delivery member, and the distal end of the delivery member is connected to the proximal end of the tightening wire.

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