CN115024863A

CN115024863A - Anchor assembly, implant, transcatheter retraction system and use thereof

Info

Publication number: CN115024863A
Application number: CN202210498685.1A
Authority: CN
Inventors: 匡经旭; 张庭超; 郭荣辉
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2021-09-03
Filing date: 2022-05-09
Publication date: 2022-09-09
Also published as: WO2023029725A1; CN115024862A; CN114392011A

Abstract

An anchor assembly, implant, transcatheter retraction loop system and applications thereof are disclosed. The anchor assembly includes an anchor, a connector, and a thimble. The anchor is for anchoring into a target tissue. The connecting piece is sleeved on the anchoring piece. The threading ring is movably connected with the connecting piece, the threading ring is provided with a first rotating shaft perpendicular to the central shaft of the anchoring piece, and the threading ring rotates around the first rotating shaft to be close to or far away from the anchoring piece. In the anchor assembly of the embodiments of the present application, the grommet is rotatable about a first rotational axis perpendicular to a central axis of the anchor to be adjacent to the anchor. In this way, the radial dimension of the anchor assembly can be reduced so that the anchor assembly can be quickly and smoothly delivered to the target tissue through the guide sheath; and the guiding sheath with smaller pipe diameter size can be selected to reduce the damage to the patient.

Description

Anchor assembly, implant, transcatheter retraction system and use thereof

The present application claims priority from the chinese patent application filed on 03/09.2021 by the chinese patent office under the name "anti-wind delivery device and transcatheter retraction system" under the application number 202111032580.9, the entire contents of which are incorporated herein by reference.

Technical Field

The present application relates to the field of medical device technology, and in particular, to an anchor assembly, an implant, a transcatheter retraction loop system, and applications thereof.

Background

Mitral regurgitation, tricuspid regurgitation, is a common heart valve disease that is traditionally treated by surgical valve repair or replacement to relieve symptoms and prolong the life of the patient. However, surgical procedures have the disadvantages of high trauma, slow recovery, high risk, etc. In recent years, the treatment of mitral regurgitation as well as tricuspid regurgitation by way of minimally invasive interventions has become a research hotspot. Among them, annuloplasty is a common intervention type of repair, in which a number of anchors connected in series by sutures are implanted in the mitral valve annulus or the tricuspid valve annulus, and the size of the patient's valve annulus is reduced by reducing the space between the anchors so as to achieve the purpose of reducing the regurgitation of blood. In the prior art, the rivet is sleeved with a threading structure, and the threading structure is connected with a suture. The radial size of the anchor is increased due to the existence of the threading structure, the anchor is not beneficial to being conveyed into the heart of a human body, and the guide sheath with larger pipe diameter is easy to damage a patient.

Disclosure of Invention

In a first aspect, the present application is directed to an anchor assembly. The anchor assembly includes an anchor, a connector, and a thimble. The anchor is for anchoring into a target tissue. The connecting piece is sleeved on the anchoring piece. The threading ring is movably connected with the connecting piece, the threading ring is provided with a first rotating shaft perpendicular to the central shaft of the anchoring piece, and the threading ring rotates around the first rotating shaft to be close to or far away from the anchoring piece.

In a second aspect, the present application also provides an implant. The implant includes a cinch cord and a plurality of anchor assemblies as described above. A plurality of the anchor assemblies are connected by the cinch wire. The distal end of the cinch wire is attached to the loop of the first of the anchor assemblies for anchoring into the target tissue, and the proximal end of the cinch wire is slidably threaded through the loops of the other anchor assemblies for anchoring into the target tissue.

In a third aspect, the present application also provides a transcatheter retraction system. The transcatheter retraction system includes an anchoring device, a delivery device, and an implant as described above. The delivery device comprises a delivery sheath, the anchoring assembly is detachably connected to the distal end of the anchoring device and penetrates through the delivery sheath, the delivery sheath is used for delivering the anchoring assembly and the tightening wire to the target tissue, and the anchoring device is used for driving the anchoring assembly to be anchored into the target tissue.

In a fourth aspect, the present application also provides the use of a transcatheter retraction system as described above for contracting an annulus in an annuloplasty procedure or for reducing ventricular volume in a ventricular volume reduction procedure.

In the anchor assembly, implant, transcatheter retraction system and use thereof provided herein, the grommet is rotatable about a first axis of rotation perpendicular to a central axis of the anchor to approximate the anchor. In this way, the radial dimension of the anchor assembly can be reduced so that the anchor assembly can be quickly and smoothly delivered to the target tissue through the guide sheath; and a guiding sheath with smaller diameter size can be selected to reduce the harm to the patient.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a schematic view of an implant provided in an embodiment of the present application after implantation in a mitral valve annulus and tightening of a tightening wire.

Fig. 2 is a schematic view of an implant provided in an embodiment of the present application after implantation in the tricuspid annulus and tightening of the wire.

Fig. 3 is a schematic view of an anchor assembly and an anchor device according to an embodiment of the present disclosure.

Fig. 4 is a schematic view of an anchor assembly provided in accordance with an embodiment of the present application threaded onto a distal end of a delivery sheath.

Fig. 5 is a schematic view of a delivery sheath threaded over a guiding sheath according to an embodiment of the present application.

FIG. 6 is a schematic structural view of an anchor assembly provided in accordance with an embodiment of the present application.

Fig. 7 is a schematic view of the anchor assembly of fig. 6 with the wire threaded about the first rotational axis.

FIG. 8 is a schematic illustration of the delivery member, cinch line and first anchor assembly provided in accordance with an embodiment of the present application.

FIG. 9 is a schematic view of a connection of a tensioning wire to other anchor assemblies provided in accordance with an embodiment of the present application.

Fig. 10 is a perspective exploded view of the anchor assembly of fig. 6.

Fig. 11 and 12 are schematic views of the anchor assembly of fig. 6 with the wire threaded about the second axis of rotation.

Fig. 13 is a schematic view of the connecting member of the anchor assembly of fig. 6 rotated about the central axis of the anchor.

Fig. 14 is a schematic illustration of the anchor assembly of fig. 3 separated from the anchoring device.

Fig. 15 is a schematic structural diagram of a stopper portion according to an embodiment of the present application.

Fig. 16 is a schematic structural diagram of a wire rewinding device according to an embodiment of the present application.

Figure 17 is a schematic view of the wire takeup device of figure 16 with the proximal portion of the housing removed.

Fig. 18 is a partial structure schematic view of the wire rewinding device in fig. 16.

Figure 19 is an axial cross-sectional view of the wire takeup device of figure 16 coupled with the adjustment device.

Fig. 20 is a schematic view of the pushing rod pushing the spacer.

Fig. 21-27 are schematic views of a transcatheter annuloplasty procedure provided in accordance with an embodiment of the present application.

Fig. 28-30 are schematic views of a transcatheter ring reduction system provided in accordance with an embodiment of the present application, as applied to tricuspid annuloplasty.

The following detailed description will further illustrate the present application in conjunction with the above-described figures.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments in the present application, are within the scope of protection of the present application.

In addition, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the application may be practiced. Directional phrases referred to in this application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", and the like, refer to the orientation as shown in the attached drawings only, and thus, are used for better and clearer illustration and understanding of the present application, rather than to indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present application.

It should be noted that the terms "proximal" and "distal" are used herein as terms customary in the medical field of intervention. Specifically, "distal" refers to the end of the surgical procedure that is distal from the operator, and "proximal" refers to the end of the surgical procedure that is proximal to the operator. Axial refers to a direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential refers to a direction around the axial direction. The central axis of the instrument or component refers to a straight line which is located at the center of the instrument or component and around which the instrument or component can rotate, or a straight line which is approximately located at the center of the instrument or component and around which the instrument or component can rotate, and the instrument or component may be an axisymmetric object or a non-axisymmetric object.

It is noted that the term "end" as used herein, whether in the context of "proximal end", "distal end", "one end", "another end", "first end", "second end", "initial end", "distal end", "both ends", "free end", "upper end", "lower end", and the like, is not limited to a tip, end or end surface, but also includes a portion extending an axial and/or radial distance from the tip, end or end surface over the component to which the tip, end or end surface pertains. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

Referring to fig. 1-5, the present application provides a transcatheter retraction system for implanting a plurality of anchor assemblies 12 connected in series by tightening wires 14 in a heart tissue, such as the mitral valve annulus or the tricuspid valve annulus, and for directly contracting the valve annulus by tightening the wires 14 to reduce the spacing between the plurality of anchor assemblies 12, thereby treating mitral regurgitation or tricuspid regurgitation.

In the present application, a transcatheter retraction system includes an implant 10, an anchoring device 20, and a delivery device 30. Wherein the implant 10 includes a plurality of anchor assemblies 12 and a tightening wire 14, the plurality of anchor assemblies 12 being connected by the tightening wire 14. The anchor assembly 12 is configured to anchor into target tissue, such as heart tissue, e.g., mitral valve annulus, tricuspid valve annulus, etc. The delivery device 30 includes a delivery sheath 32, the anchor assembly 12 is detachably connected to the distal end of the anchor assembly 20 and threaded through the delivery sheath 32, the delivery sheath 32 is used for delivering the anchor assembly 12 and the tensioning wire 14 to the target tissue, and the anchor assembly 20 is used for driving the anchor assembly 12 to anchor into the target tissue. The target tissue is taken as an example of the valve ring.

It will be appreciated that the transcatheter retraction system further includes at least one guiding sheath 40 for establishing an access path from outside the patient's body to the heart, the distal portion of the delivery sheath 32 being flexible, and the delivery sheath 32 being configured to deliver the anchor assembly 12 and the cinch wire 14 through the guiding sheath 40 and into the heart. In some embodiments, the number of the guiding sheaths 40 is two, which are a first guiding sheath and a second guiding sheath penetrating the first guiding sheath, and the second guiding sheath can extend from the distal end of the first guiding sheath and fit on the valve annulus. Preferably, the first guiding sheath and the second guiding sheath are both bending-adjustable sheaths, so as to adjust the bending angle and direction of the distal end thereof, thereby facilitating the adjustment of the distal end of the guiding sheath 40 (especially the second guiding sheath) to the angle fitting the valve annulus. In other embodiments, only one bendable guiding sheath 40 may be used. The bendable sheath is a commonly used guiding device for interventional operation in the prior art, and is not described herein.

Referring to fig. 6 and 7, the present application provides an anchor assembly 12 including an anchor 120, a connector 126, and a cable loop 128. The anchor 120 is used to anchor into the annulus (i.e., the target tissue). The connecting member 126 is disposed on the anchoring member 120. A cable 128 is movably connected to the connecting member 126, the cable 128 having a first rotational axis M perpendicular to the central axis X of the anchoring element 120, the cable 128 being rotatable about the first rotational axis M to move toward and away from the anchoring element 120.

It will be appreciated that the thimble 128 is rotatable about a first axis of rotation M perpendicular to the central axis X of the anchor 120 to approximate the anchor 120. In this way, the radial dimension of the anchor assembly 12 can be reduced for quick and smooth delivery of the anchor assembly 12 through the guide sheath 40 to the annulus; and a guiding sheath 40 with a smaller tube diameter size can be selected to reduce injury to the patient.

Referring to fig. 4 and 5, in some embodiments, the wall of the delivery sheath 32 is provided with a through groove 322 extending from the distal end to the proximal end, the through groove 322 is communicated with the inner cavity of the delivery sheath 32, and the distal end of the through groove 322 is provided with an opening. When anchor assembly 12 is threaded into delivery sheath 32, anchor 120 is positioned within the lumen of delivery sheath 32, connector 126 is passed through channel 322, and collar 128 is positioned outside delivery sheath 32. Since the threading ring 128 is located outside the delivery sheath 32, the threading ring 128 can rotate around the first rotation axis M to approach the anchoring element 120, and the threading ring 128 can abut against the wall of the delivery sheath 32 to reduce the radial dimension, so that the delivery sheath 32 can pass through the guiding sheath 40 quickly and smoothly when delivering the anchoring element 12. Additionally, the anchor assembly 12 is threaded such that a delivery sheath 32 of smaller tubular diameter may be used, and thus a guide sheath 40 of smaller tubular diameter may be used.

In other embodiments, the wall of the delivery sheath 32 may not be provided with through slots 322. When the anchor assembly 12 is threaded through the delivery sheath 32, the anchor assembly 12 is entirely disposed within the lumen of the delivery sheath 32. Since the threading ring 128 is rotatable about the first rotation axis M to approach the anchoring element 120, the threading ring 128 can abut against the anchoring element 120 to reduce the radial dimension, and the required diameter of the delivery sheath 32 is relatively small, so that the delivery sheath 32 can pass through the guiding sheath 40 quickly and smoothly while delivering the anchoring element 12 through the guiding sheath 40, and the guiding sheath 40 with a relatively small diameter can also be used.

Referring to fig. 8 and 9, the threading ring 128 is adapted to receive the tensioning line 14. The distal end of the cinch cord 14 is attached to the thimble 128 of the first anchor assembly 12 for anchoring to the annulus (i.e., the target tissue), and the proximal end of the cinch cord 14 is slidable through the thimble 128 of the other anchor assembly 12 for anchoring to the annulus. In this manner, the cinch cord 14 is connected to the anchors 120 by the threader loop 128 and the connecting member 126, thereby connecting the plurality of anchor assemblies 12 anchored to the annulus in series, and tightening the cinch cord 14 reduces the spacing between the plurality of anchor assemblies 12, thereby achieving cinching.

In one example, the distal end of the tensioning wire 14 is attached to the thimble 128 of the first anchor assembly 12 for anchoring to the annulus via a crimp tube 142, and specifically, the tensioning wire 14 is doubled back after passing through the thimble 128 and the two free ends of the tensioning wire 14 are secured by the crimp tube 142, attaching the distal end of the tensioning wire 14 to the thimble 128. The pressing tube 142 may be made of a metal material with good biocompatibility (such as, but not limited to, stainless steel), and is pressed by a press to fix both free ends of the tightening wire 14. Preferably, the crimp tube 142 is integrally wrapped with a covering film to reduce the risk of damage to heart tissue, such as the valve annulus, by the crimp tube 142.

Referring to fig. 10, the connecting member 126 is formed with a connecting hole 1262. The central axis Y of connecting bore 1262 is perpendicular to the central axis X of anchor 120, and the cable 128 is movably connected to connecting member 126 through connecting bore 1262. The first rotation axis M of the thimble 128 is coaxial with or parallel to the central axis Y of the connection hole 1262. Thus, the threader 128 can be rotated about the first rotational axis M to move toward or away from the anchoring element 120. The cable 128 can be rotated proximally about the first rotational axis M until contact with the anchoring element 120, and the cable 128 can also be rotated distally about the first rotational axis M until contact with the anchoring element 120. In the illustrated example, the first rotation axis M of the thimble 128 is coaxial with the central axis Y of the connection hole 1262.

The connecting member 126 also defines a mounting hole 1264, and the central axis Z of the mounting hole 1264 is coaxial with or parallel to the central axis X of the anchor 120. Anchor 120 includes an anchor portion 122 and an anchor seat 124 coupled to a proximal end of anchor portion 122, anchor seat 124 being received through mounting hole 1264. Thus, the connector 126 is positioned over the anchor 120 through the mounting hole 1264. In the illustrated example, the central axis Z of the fitting hole 1264 is coaxial with the central axis X of the anchor 120.

Referring to fig. 7, the thimble 128 has a reference plane α, which is parallel to or coincident with the plane of the mounting hole 1264 (i.e., the plane perpendicular to the central axis Z of the mounting hole 1264). The maximum angle of rotation of the grommet 128 from the reference plane α about the first rotation axis M is greater than or equal to 90 °. In this manner, the radial dimension of the anchor assembly 12 during delivery may be minimized. Preferably, the maximum angle of rotation of the thimble 128 about the first axis of rotation M from the reference plane α is greater than 90 °. It will be appreciated that the thimble 128 may be rotated clockwise from the reference plane α about the first axis of rotation M by more than 90 until contact is made with the distal end of the anchor block 124; the thimble 128 may be rotated counterclockwise from the reference plane alpha about the first axis of rotation M by an angle greater than 90 deg. until the thimble 128 contacts the proximal end of the anchor block 124.

Further, referring to fig. 1, 2, 11 and 12, the threading ring 128 further has a second rotation axis N, the second rotation axis N is perpendicular to both the central axis X of the anchor 120 and the central axis Y of the connecting hole 1262, and the threading ring 128 rotates around the second rotation axis N to incline the plane of the threading ring 128 (i.e., the plane perpendicular to the central axis of the threading ring 128) with respect to the plane of the fitting hole 1264 (i.e., the plane perpendicular to the central axis Z of the fitting hole 1264). Thus, after the anchor assembly 12 is sequentially anchored to the annulus, the anchor assembly 12 is connected to the anchor assembly 12 by the tensioning line 14, and the thimble 128 rotates around the second rotation axis N by a certain angle, so that the thimble 128 is inclined relative to the plane (i.e. the reference plane α) of the tensioning line 14, thereby reducing the friction between the thimble 128 and the tensioning line 14 and ensuring that the tensioning line 14 can smoothly move through the thimble 128 when the tensioning line 14 is tensioned.

Specifically, the maximum angle range of the rotation of the thimble 128 about the second rotation axis N from the reference plane α is 30 ° to 45 °. It will be appreciated that the maximum angle of rotation of the thimble 128 about the second axis of rotation N from the reference plane α may be 30 °, 45 ° or any number of degrees between 30 ° and 45 °. In one example, the maximum angle at which the thimble 128 can be rotated clockwise about the second rotation axis N from the reference plane α is 40 °, and the maximum angle at which the thimble 128 can be rotated counterclockwise about the second rotation axis N from the reference plane α is 40 °. The maximum angle of rotation of the thimble 128 about the second rotation axis N from the reference plane α is directly related to the size of the gap between the coupling hole 1262 and the thimble 128.

Referring to fig. 13, the anchor seat 124 is movably inserted into the mounting hole 1264, and the connecting member 126 has a rotational degree of freedom about the central axis X of the anchor 120. It will be appreciated that connecting member 126 can be rotated 360 about the central axis X of anchor 120. Thus, when the plurality of anchor assemblies 12 are anchored to the annulus, the connector 126 is rotatable about the central axis X of the anchor 120 so that the thimble 128 attached to the connector 126 can move under tension when the cinch threads 14 are cinched to a cinched configuration in which the cinch threads 14 are engaged. The threading ring 128 can rotate around the second rotation axis N to incline the threading ring 128 relative to the plane of the tightening wire 14, so that the resistance of the tightening wire 14 in the process of ring shrinkage is greatly reduced, the tightening wire 14 does not bend, and the movement is stable and smooth. In addition, because the resistance that the tightening line 14 receives in the direction of tightening up reduces greatly, the tightening force reduces and the tightening force distributes the effort on every anchor assembly 12 more evenly, and the effort that corresponding single anchor assembly 12 received also reduces greatly, has reduced the effort of anchor assembly 12 to the valve ring, has reduced the risk that the valve ring received the damage, avoids appearing the tightening force that single anchor assembly 12 received simultaneously and accounts for than great condition, has reduced the risk that anchor assembly 12 drops, implants safelyr.

Further, in some embodiments, the connecting member 126 also has translational freedom to move along the central axis X of the anchor 120. It will be appreciated that the connecting member 126 can move along the axial direction of the anchor member 120, and when the anchoring depths of the anchor members 120 of a plurality of anchor assemblies 12 are not uniform, the tightening wire 14 can pull the connecting member 126 to move up and down along the axial direction, so as to further reduce the bending of the tightening wire 14, and the tightening wires 14 can be distributed on the same plane as much as possible, thereby ensuring that the tightening wire 14 can move stably and smoothly.

Referring to fig. 10, in some embodiments, the anchor block 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 supporting portion 1246 and the supporting block 1244 form a connecting slot, the connecting element 126 is movably sleeved on the supporting portion 1246, and at least a portion of the connecting element 126 is received in the connecting slot. Specifically, the aperture of the assembly hole 1264 is larger than the radial dimension of the supporting portion 1246 and smaller than the radial dimensions of the seat body 1242 and the supporting block 1244, so that the connecting member 126 can be movably sleeved on the anchoring seat 124 and will not fall off.

Further, the anchor seat 124 further includes an insertion part 1248 connected to the distal end of the support part 1246, the support block 1244 is fixed to the proximal end of the insertion part 1248 and abuts against the distal end face of the support part 1246, and the insertion part 1248 passes through the support block 1244 and is connected to the proximal end of the anchor part 122. Specifically, the inserting portion 1248 defines an inserting hole extending along the axial direction of the anchor 120, and the proximal end of the anchoring portion 122 is inserted into the inserting hole and fixed by welding or adhesive bonding. Of course, the anchor portion 122 may also be directly fixedly connected to the distal end surface of the support block 1244 by welding or the like, and the support block 1244 is directly fixedly connected to the distal end surface of the support portion 1246, so that the insertion portion 1248 is not required.

In the illustrated example, the anchor portion 122 is a helical anchor having a pointed end that is easily anchored to cardiac tissue, such as the annulus, and is not easily dislodged after implantation of the anchor assembly 12. Of course, anchor portion 122 may be of another suitable configuration that enables anchor portion 122 to engage and substantially secure to tissue, such as, but not limited to, barbs, hooks, tines, etc., and which barbs, hooks are made at least in part of a material having a shape memory function to facilitate delivery.

In some embodiments, the thimble 128 may be a circular or elliptical ring, and the axial cross-section may also be circular or elliptical in shape. The fitting hole 1264 and the connection hole 1262 of the connector 126 may be circular holes or elliptical holes. In some examples, the thimble 128 is a circular ring and its axial cross-sectional shape is also circular; the fitting hole 1264 and the connecting hole 1262 of the connecting member 126 are circular holes. In other embodiments, the thimble 128 may be an irregular ring-shaped structure, and the fitting hole 1264 and the connecting hole 1262 of the connecting member 126 may be irregularly shaped holes.

Referring to fig. 3 and 14, the anchor assembly 12 is removably attached to the distal end of the anchor device 20. In some embodiments, the anchoring device 20 includes a drive tube 22 and a connecting rod 24 that is threaded into the drive tube 22. The distal end of the driving tube 22 is provided with a connecting portion 222 detachably connected to the seat body 1242 of the anchoring seat 124, the connecting rod 24 is axially inserted through the connecting portion 222 and the seat body 1242 in matching connection to keep the anchoring assembly 12 connected to the anchoring device 20, and the driving tube 22 is used for driving the anchoring assembly 12 (i.e., the anchor 120) to be anchored into the valve annulus.

The proximal end of the seat body 1242 is an S-shaped buckle, the connecting portion 222 is another S-shaped buckle correspondingly matched with the proximal end of the seat body 1242, and both the seat body 1242 and the connecting portion 222 have an inner cavity. As shown in fig. 14, when the connecting portion 222 and the seat body 1242 are abutted, the two S-shaped buckles are buckled, the inner cavities of the two S-shaped buckles are communicated, the distal end of the connecting rod 24 inserted into the driving tube 22 extends out of the distal end of the driving tube 22 and is inserted into the inner cavities of the connecting portion 222 and the seat body 1242, so as to limit the separation of the connecting portion 222 and the seat body 1242, so that the anchoring component 12 is connected with the driving tube 22, and the driving tube 22 is rotated to drive the anchor 120 to rotate, thereby anchoring the anchoring portion 122 in the valve annulus. It will be appreciated that when the distal end of the connecting rod 24 is withdrawn from the abutting engagement between the seat 1242 and the connector 222, the seat 1242 and the connector 222 may be separated, thereby effecting separation of the anchor assembly 12 from the drive tube 22. The anchoring device 20 may be made of a metal material or a polymer material, preferably a metal material with high hardness such as stainless steel.

In other embodiments, the holder 1242 and the connecting portion 222 can be a fitting structure of a latch and a slot. The anchoring device 20 may also be composed of a driving tube 22 and a connecting tube sleeved outside the driving tube 22, wherein the distal end of the connecting tube is sleeved outside the connecting portion 222 and the seat body 1242 which are connected in a matching manner, and the connecting tube also has the function of limiting the separation of the connecting portion 222 and the seat body 1242.

Referring to fig. 4, in some embodiments, the connector 126 of the anchor assembly 12 has a retaining end 1266, and the cable loop 128 is movably connected to the retaining end 1266. The radial width of the catching end 1266 is adapted to the radial width of the through slot 322 of the delivery sheath 32, and the catching end 1266 is axially movably caught in the through slot 322. Specifically, the connecting hole 1262 is opened at the catching end 1266, and the threading ring 128 passes through the connecting hole 1262 to be movably connected with the catching end 1266 of the connecting member 126. Thus, retaining end 1266 of connector 126 is retained in channel 322, the remainder of connector 126 and anchor 120 are located in the lumen of delivery sheath 32, and collar 128 is located outside of delivery sheath 32. When the distal end face of the delivery sheath 32 is held against the annulus, the anchor 120 is rotated by the anchoring device 20 to extend the anchor 120 from the distal end of the delivery sheath 32 to anchor into the annulus, and at this time, due to the restriction of the holding end 1266 by the through groove 322, the connector 126 does not rotate relative to the delivery sheath 32, but the connector 126 moves relative to the delivery sheath 32 together with the anchor 120 in the direction of the opening of the through groove 322.

Further, gripping end 1266 is provided with a guiding ramp 1268 projecting proximally in the axial direction of anchor 120. It will be appreciated that after the anchor assembly 12 is released from the delivery sheath 32, if the anchor site is not appropriate, it may need to be withdrawn into the delivery sheath 32 to re-select the anchor site. The provision of the guide ramp 1268 facilitates the retraction of the anchor assembly 12 into the delivery sheath 32, preventing the anchor assembly 12 from jamming.

It should be noted that to ensure safety after implantation, the anchor assembly 12 is made entirely of a material having good biocompatibility, including, but not limited to, metallic materials, such as stainless steel; or a polymer material such as Polyetheretherketone (PEEK), Polyethylene terephthalate (PET).

Referring to fig. 4 again, in some embodiments, the delivering device 30 further includes a stopping portion 34, the stopping portion 34 is movably disposed at the distal end of the delivering sheath 32, and the stopping portion 34 is used for closing the opening of the through slot 322. It will be appreciated that the stop 34 is movable to open or close the opening of the channel 322 to facilitate threading of the anchor assembly 12 or attachment of the takeup wire 14. When the anchor assembly 12 is threaded into the delivery sheath 32 and receives the tensioning wire 14, at least a portion of the anchor assembly 12, such as the anchor 120, is received within the lumen of the delivery sheath 32, and the distal end of the anchor 120 is spaced from the tensioning wire 14 by the stop 34, such that the portion of the tensioning wire 14 extending distally from its connection with the loop 128 of the anchor assembly 12 is outside the delivery sheath 32, thereby preventing the tensioning wire 14 from becoming entangled with the anchor 120, avoiding the risk of coiling, and facilitating smooth implantation of the anchor assembly 12. The portion of the tensioning wire 14 extending proximally from its connection with the threading ring 128 may be located within the lumen of the delivery sheath 32 or may be located outside of the delivery sheath 32.

In the preferred embodiment of the present application, anchor 120 is positioned within the lumen of delivery sheath 32, retaining end 1266 of connector 126 is retained within channel 322, the remainder of connector 126 is positioned within the lumen of delivery sheath 32, and collar 128 is positioned outside of delivery sheath 32; the tensioning wire 14 is connected to the threading ring 128, and the tensioning wire 14 is located entirely outside the delivery sheath 32. When the anchoring assembly 12 is inserted into the sheath 32, first, the control stopper 34 opens the opening of the through slot 322; the anchor 120 is then threaded into the lumen of the delivery sheath 32, with the capturing end 1266 of the connector 126 slid from the opening into the channel 322 as the anchor 120 is moved, and the collar 128 positioned outside the delivery sheath 32 for connection of the tightening wire 14; then, the stopper 34 is controlled to close the opening of the through-slot 322 so that the stopper 34 separates the anchor 120 from the tightening wire 14.

Alternatively, the proximal end of the through slot 322 may be closed or may extend axially of the delivery sheath 32 to the proximal end of the through delivery sheath 32. Preferably, the proximal ends of the through slots 322 are closed, the through slots 322 do not penetrate through the opposite end ends of the delivery sheath 32, and the structural strength of the delivery sheath 32 is high. Referring to fig. 9, the axial length of the through slot 322 is greater than the axial distance H from the proximal end of the connecting member 126 to the distal end of the anchoring portion 122, so that the entire anchoring element 120 can be accommodated in the inner cavity of the delivery sheath 32, and the anchoring element 120 and the tightening wire 14 are completely isolated from the inner side and the outer side of the delivery sheath 32, which is further beneficial to avoiding the problem of wire winding during the delivery and implantation of the anchoring element 12.

In some embodiments, the openings of the through slots 322 are chamfered or filleted such that the openings of the through slots 322 are flared. It will be appreciated that the flared shape of the opening facilitates entry of the retention end 1266 of the connector 126 into the channel 322 during threading of the anchor assembly 12 through the delivery sheath 32, thereby facilitating assembly of the anchor assembly 12.

Referring to fig. 15, in some embodiments, the proximal end of the stopper 34 extends in the axial direction of the delivery sheath 32, and the distal end of the stopper 34 fits around the delivery sheath 32 and closes the opening of the through slot 322 when not subjected to external forces. It is understood that the stopping portion 34 is an elongated member, and at least a distal portion of the stopping portion 34 is made of a material having a shape memory function (such as, but not limited to, nickel titanium alloy, etc.), that is, the distal end of the stopping portion 34 is made of a material having a shape memory function, or the stopping portion 34 is made of a material having a shape memory function as a whole. Preferably, the distal end of the stopping portion 34 is a non-closed loop in a natural state, so that the stopping portion 34 has good guidance and is easy to retract, the moving stroke of the stopping portion 34 can be increased, the distal end of the stopping portion 34 can be ensured to pass through the through groove 322 to form a blocking effect, the opening of the through groove 322 is sealed firmly and stably, and the stopping portion 34 can be ensured to have sufficient strength and is not easy to break. Naturally, the distal end of the stop 34 may also be an arc segment that fits the circumference of the delivery sheath 32 in the natural state. It should be noted that the natural state means that the stopper portion 34 is not subjected to any external force.

In one possible embodiment, the stopper 34 may be a wire made of nitinol, and the distal end of the wire is heat-set to form a non-closed loop. The distal end of the delivery sheath 32 is circumferentially provided with a wire blocking channel 324, the distal end of the wire blocking is movably inserted into the wire blocking channel 324, and the proximal end of the wire blocking movably extends axially in the tube wall or lumen of the delivery sheath 32. It can be understood that the distal end of the wire block closes the opening of the through slot 322 when not being acted by an external force, and the connecting member 126 of the anchor assembly 12 cannot slide out of the opening of the through slot 322 due to the stopping of the wire block, so that the anchor assembly 12 can be prevented from being separated from the delivery sheath 32 during the delivery process, and the anchor 120 of the anchor assembly 12 is ensured to be always in the inner cavity of the delivery sheath 32 during the delivery process, thereby avoiding the tightening wire 14 from being wound around the anchor 120.

In the above embodiment, the distance that the wire can be pulled to move is greater than the radial width of the through slots 322 so that the openings of the through slots 322 can be fully opened so as not to prevent the connectors 126 of the anchor assembly 12 from sliding out of the through slots 322. The radial cross-sectional shape of the wire stopper may be circular, oblate, rectangular, square, or other shapes, and the like, which is not limited in this application. In some examples, the radial cross-sectional shape of the wire stopper is circular, so that the diameter of the wire stopper cannot be too small to avoid breakage of the wire stopper when pulled, and the diameter of the wire stopper can range from 0.2mm to 0.8 mm.

Referring again to fig. 1 and 2, in some embodiments, implant 10 further includes at least one spacer 16, wherein spacer 16 is threaded onto tightening wire 14, and spacer 16 is positioned between two adjacent anchor assemblies 12. It will be appreciated that spacer 16 prevents the tightening wire 14 from being tightened too much, which may cause the distance between two adjacent anchor assemblies 12 to be too short and damage the annulus, while spacer 16 may provide cushioning, distribute the tightening force to which the anchor assemblies 12 are subjected, and ensure stable implantation of the anchor assemblies 12. The spacer 16 is a cylinder with a certain length, and is preferably made of a biocompatible material. The spacer 16 may be wrapped with a covering membrane to reduce the risk of target tissue, such as the annulus, being damaged by the spacer 16.

Optionally, a spacer 16 may be disposed between any two adjacent anchor assemblies 12 of the plurality of anchor assemblies 12 of the implant 10, or a spacer 16 may be disposed at two or more intervals between two or more anchor assemblies 12, which is not limited in this respect.

Referring to fig. 1, 2, 16-19, in some embodiments, the implant 10 further includes a wire retractor 18. The wire-rewinding device 18 includes a housing 182 and a spool 184 rotatably disposed in the housing 182. The proximal end of the cinch cord 14 is movably threaded through the housing 182 and the spool 184. The spool 184 rotates relative to the housing 182 to wind the takeup wire 14, and when the spool 184 stops rotating, the takeup wire 14 is fixed in the radial space between the spool 184 and the housing 182.

It will be appreciated that by controlling the rotation of the spool 184 relative to the housing 182 to wind the cinch cord 14, such that the cinch cord 14 is continuously tightened to reduce the spacing between the plurality of anchor assemblies 12 to constrict the annulus, the rotation of the spool 184 is stopped until the flow of regurgitation is reduced or eliminated, at which time the cinch cord 14 is secured in the radial space between the spool 184 and the housing 182, and the cinch cord 14 remains at a length on the annulus. The take-up device 18 is used for winding and locking the tightening wire 14, so that the tightening wire 14 has good locking effect. Furthermore, if the regurgitation recurs after a period of time, which is caused by the enlargement of the valve ring, the wire-rewinding device 18 can be controlled directly to further wind the wire 14 to shrink the valve ring so as to reduce or eliminate the regurgitation, thereby avoiding the secondary operation from causing great harm to the patient. The wire take-up device 18 may be made of a biocompatible material, such as stainless steel, but is not limited thereto.

It should be noted that the tightening wire 14 is wound on the bobbin 184 for at least three turns, and the friction between each turn of the tightening wire 14 can counteract the pulling force generated by the leaflet motion, so as to ensure that the tightening wire 14 is not pulled and the tightening wire 14 maintains a certain length on the valve annulus.

Specifically, the housing 182 includes a bottom case 1822 and a shell 1824. The housing 1824 has openings at both proximal and distal ends thereof, and the bottom case 1822 is fixedly coupled to the distal end of the housing 1824 to form an installation space. The wire rewinding device 18 further comprises a limiting post 186, a stopping wheel 188 and an elastic member 181. The limiting column 186, the elastic member 181, the rotation stopping wheel 188 and the winding shaft 184 are disposed in the installation space of the housing 182.

As shown in fig. 17, the bobbin 184 is provided with a winding hole 1844 along a radial direction thereof, and the housing 1824 is provided with a threading hole 1826 at both sides of the bobbin 184, and both the threading holes 1826 communicate with the winding hole 1844 of the bobbin 184. When the thread take-up device 18 is threaded on the tension thread 14, the tension thread 14 is first threaded into the installation space of the housing 182 through one thread hole 1826, then threaded through the thread hole 1844 of the bobbin 184, and then threaded out of the housing 182 through the other thread hole 1826. Preferably, the central axes of the two threading holes 1826 are coplanar with the central axis of the winding hole 1844, and the winding shaft 184 is rotated such that the central axis of the winding hole 1844 is collinear with the central axes of the two threading holes 1826, which facilitates smooth passage of the cinch line 14 through the two threading

holes

1826 and 1844.

As shown in fig. 18 and 19, the distal end of the restraining post 186 is fixedly attached to the bottom housing 1822. The rotation stopping wheel 188 is axially movably sleeved on the limiting column 186 and is stopped to rotate relative to the limiting column 186, the elastic element 181 abuts between the bottom shell 1822 and the rotation stopping wheel 188, and the winding shaft 184 is rotatably sleeved on the limiting column 186. The proximal end of the stop wheel 188 is circumferentially provided with a plurality of first helical teeth 1882, the distal end of the spool 184 is circumferentially provided with a plurality of second helical teeth 1846, and the second helical teeth 1846 are in one-way rotation fit with the first helical teeth 1882.

Specifically, the proximal end of the rotation stopping wheel 188 is further provided with a limiting boss 1884, the distal end of the housing 1824 is correspondingly provided with a limiting groove 1828, the rotation stopping wheel 188 is sleeved on the limiting column 186, and the limiting boss 1884 is clamped in the corresponding limiting groove 1828, so that the rotation of the rotation stopping wheel 188 relative to the limiting column 186 can be limited, and the rotation stopping wheel 188 can axially move along the limiting column 186. The distal end surface of the bobbin 184 is further provided with a groove (not shown) matching with the proximal end of the limiting post 186, the proximal end portion of the limiting post 186 is received in the groove at the distal end of the bobbin 184, and the proximal end surface of the limiting post 186 contacts with the distal end surface of the bobbin 184, so as to limit the axial displacement of the bobbin 184 in the installation space together with the proximal end of the housing 1824, so that the bobbin 184 can only rotate. The elastic member 181 is disposed between the rotation stop wheel 188 and the bottom housing 1822, one end of the elastic member 181 abuts against the bottom housing 1822, the other end abuts against the rotation stop wheel 188, and the elastic member 181 is used for providing an elastic force to the rotation stop wheel 188, so that the first inclined teeth 1882 of the rotation stop wheel 188 abut against the second inclined teeth 1846 of the winding shaft 184. The elastic member 181 may be, but is not limited to, a spring, a tubular elastic sheet, an elastic bellows, etc.

When the spool 184 rotates forward relative to the housing 182 and the rotation stop wheel 188, the second helical tooth 1846 slips on the first helical tooth 1882 to move the rotation stop wheel 188 distally, and when the spool 184 rotates relative to the rotation stop wheel 188 by an angle of one helical tooth, the rotation stop wheel 188 is moved proximally by the elastic force of the elastic member 181, so that the first helical tooth 1882 and the second helical tooth 1846 are attached again, and the spool 184 can continue to rotate relative to the housing 182 and the rotation stop wheel 188. When the spool 184 is to be rotated in the reverse direction, the second helical teeth 1846 will not move the stop wheel 188 distally due to the interference of the first helical teeth 1882, resulting in the spool 184 not being able to be reversed. Therefore, when the spool 184 stops rotating, the takeup wire 14 is fixed in the radial space between the spool 184 and the housing 182. The radial space is a space defined by the bobbin 184 and the housing 1824, and is a part of the installation space.

In other embodiments, after the plurality of anchor assemblies 12 and spacers 16 are implanted into the annulus and the tightening line 14 is pulled to constrict the annulus to reduce or eliminate the regurgitation of blood, a staple may be fed along the tightening line 14 to lock the tightened tightening line 14 so that the tightening line 14 remains in the tightened state and the excess portion of the tightening line 14 may be trimmed.

Referring again to FIG. 8, in some embodiments, delivery device 30 further includes a delivery element 36, a distal end of delivery element 36 being coupled to a proximal end of the cinch line 14, and a proximal end of delivery element 36 extending outside of the body. In this way, the anchor assembly 12, the spacer 16, the wire retractor 18, etc. can be threaded onto the cinch wire 14 by the delivery of the delivery member 36, such that the cinch wire 14 can be selected to an appropriate implantation length, thereby eliminating the need to cut the cinch wire 14 in vivo, avoiding the shedding of particles from the wire, and providing a safer cinch ring procedure.

It should be noted that the distal end of the cinch cord 14 is connected to the first anchor assembly 12 for anchoring to the annulus, and the other anchor assemblies 12 for anchoring to the annulus are delivered along the delivery member 36 and threaded onto the cinch cord 14. Likewise, the spacer 16 and the take-up device 18 are also fed along the feed member 36 and threaded onto the takeup wire 14. The tightening wire 14 has a certain axial length and is flexible, and the radial section of the tightening wire 14 can be round, oblate, rectangular, square or other shapes; similarly, the conveying member 36 has a certain axial length and flexibility, and the radial cross-sectional shape of the conveying member 36 may also be a circle, an oblate, a rectangle, a square, or other shapes; the radial cross-sectional shape of the takeup wire 14 and the conveying member 36 is not particularly limited in this application.

In some embodiments, the proximal end of the cinch line 14 is doubled back to form a U-shape and the transport element 36 is a transport line that passes through the doubled back portion of the cinch line 14 to provide a detachable connection. Of course, the delivery wire may also be non-removably attached to the puller wire 14 by shearing the delivery wire in vitro to withdraw the delivery wire out of the body. In other embodiments, the conveying element 36 may be detachably connected to the tightening wire 14 by a screw connection, a snap connection, or the like, which will not be described in detail.

After implanting the plurality of anchor assemblies 12 and the spacer 16 in the annulus, the delivery member 36 is withdrawn by threading the take-up device 18 along the delivery member 36 on the cinch line 14, then tightening the cinch line 14 using the take-up device 18 and securing the cinch line 14 to maintain the cinch line 14 at the annulus for a length to release the cinch line 14 to complete the cinch to alleviate blood reflux. It can be appreciated that the delivery member 36 allows the wire rewinding device 18 to be threaded onto the tightening wire 14 and smoothly releases the tightening wire 14 without implanting the wire rewinding device 18 into the patient in advance, thereby simplifying the surgical procedure, reducing the surgical difficulty and shortening the surgical time.

Referring to FIG. 20, in some embodiments, the transcatheter retraction system further includes a push rod 50 for pushing the spacer 16. Specifically, the distal end of the pushing rod 50 is opened with a guiding hole 52 for the proximal end of the conveying element 36 to movably pass through. After the spacer 16 is threaded onto the delivery member 36, the delivery member 36 is threaded through the guide hole 52 of the pushing rod 50, the pushing rod 50 pushes the spacer 16 along the delivery member 36 into the guide sheath 40, and then the delivery sheath 32 is threaded into the guide sheath 40 to push the spacer 16 in the guide sheath 40, so that the spacer 16 is threaded onto the takeup wire 14 along the delivery member 36.

It will be appreciated that after implantation of the first anchoring assembly 12 in the valve annulus, the delivery sheath 32 and anchoring device 20 are withdrawn, and the pusher rod 50 pushes the spacer 16 in direction b along the delivery member 36 into the guiding sheath 40 after threading the proximal end of the delivery member 36 through the spacer 16 and passing the delivery member 36 through the guiding hole 52 of the pusher rod 50 in direction a. The pushing rod 50 is then removed, and the second anchoring assembly 12 threaded through the delivery sheath 32 is threaded onto the delivery member 36 via the threading ring 128 exposed outside the delivery sheath 32, and the delivery sheath 32 is further threaded into the guiding sheath 40, with the spacer 16 on the distal side of the delivery sheath 32. Thus, the delivery sheath 32 is moved axially distally within the guide sheath 40 to thread the spacer 16 and second anchor assembly 12 along the delivery element 36 onto the puller wire 14 and to advance the spacer 16 to the annulus, and then the anchoring device 20 pushes the second anchor assembly 12 out of the delivery sheath 32 and anchors the second anchor assembly 12 to the annulus so that the spacer 16 is positioned between the two anchor assemblies 12. The same procedure is repeated, sequentially implanting a plurality of anchor assemblies 12 into the annulus, with spacers 16 sequentially inserted between each two or more anchor assemblies 12. Wherein the distance between the anchor points of two adjacent anchor assemblies 12 needs to be greater than the axial length of the spacer 16.

Referring to FIG. 19, in some embodiments, the transcatheter retraction system further comprises an adjustment device 60, wherein the wire drawer 18 is removably coupled to a distal end of the adjustment device 60, and wherein the adjustment device 60 is configured to actuate the wire drawer 18 to retract the tensioning wire 14. Specifically, the adjusting device 60 includes a threaded rod 62, a rotating tube 64 and an outer sheath tube 66, which are sleeved from inside to outside. In the wire takeup device 18, the proximal end of the spool 184 projects from the proximal opening of the housing 1824 and the proximal end of the spool 184 is provided with a threaded hole 1842 along the axial direction thereof. Wherein the distal end of the outer sheath 66 is snapped to the housing 182 to restrict the rotation of the housing 182; the far end of the rotating tube 64 is sleeved on the near end of the winding shaft 184, and the rotating tube 64 and the winding shaft 184 are relatively prevented from rotating; threaded rod 62 is threadably coupled to threaded hole 1842 to maintain the connection of rotary tube 64 to spool 184. Therefore, the winding shaft 184 is rotated by rotating the rotary tube 64 to wind the takeup wire 14 to take up the takeup wire 14.

In some embodiments, the housing 1824 of the housing 182 is provided with a detent 1821, the distal end of the outer sheath 66 is provided with a detent 662 corresponding to the detent 1821, and the outer sheath 66 is coupled to the housing 182 by the engagement of the detent 662 with the detent 1821. The outer wall of the rotating tube 64 is further provided with a first boss 642 in a protruding manner, the claw 662 is clamped with the clamping groove 1821, and after the distal end of the rotating tube 64 is sleeved on the proximal end of the winding shaft 184, the first boss 642 can press the claw 662 against the housing 182 to limit the proximal movement of the outer sheath tube 66, so that the outer sheath tube 66 and the housing 182 are kept connected. The inner wall of the rotary tube 64 is further convexly provided with a second boss 644, the outer wall of the threaded rod 62 is convexly provided with a third boss 622, the far end of the rotary tube 64 is sleeved on the near end of the winding shaft 184, and after the threaded rod 62 is screwed with the threaded hole 1842, the third boss 622 can press the second boss 644 on the winding shaft 184 to limit the rotary tube 64 to move towards the near end, so that the rotary tube 64 is kept connected with the winding shaft 184. At this time, the outer sheath 66 restricts the rotation of the housing 182, and the rotation of the rotary tube 64 drives the threaded rod 62 and the spool 184 to rotate synchronously, so that the spool 184 rotates relative to the housing 182 to wind the tightening wire 14 and tighten the tightening wire 14, thereby realizing the loop shrinkage.

The following will describe the operation and working principle of the transcatheter ring reduction system according to the embodiment of the present application in mitral valve annuloplasty by way of example with reference to fig. 1, 20, and 21-27. Wherein, the operation path is as follows: transfemoral-inferior vena cava-Right Atrium (RA) -interatrial septum (AS) -Left Atrium (LA) -annulus of Mitral Valve (MV).

In the first step, transforaminal vein puncture is performed, and a guide wire (instruments such as a guide wire and an interatrial puncture device are not shown in the figure) is used for establishing a track of the femoral vein-inferior vena cava-right atrium-interatrial-left atrium-mitral valve annulus.

In a second step, as shown in fig. 21, the guiding sheath 40 is advanced over the guide wire until its distal end passes through the foramen ovale to the left atrium and is advanced to the vicinity of the mitral annulus, and the guide wire is withdrawn.

Third, as shown in FIG. 22, the cable loop 128 of the first anchor assembly 12 is attached to the distal end of the cinch line 14 and the proximal end of the cinch line 14 is removably attached to the distal end of the delivery member 36. First, the first anchor assembly 12 is detachably connected to the anchoring device 20 and mounted to the distal end of the delivery sheath 32, wherein the threading ring 128, the tensioning wire 14 and the delivery member 36 of the first anchor assembly 12 are positioned outside the delivery sheath 32; the delivery sheath 32 is then moved axially distally in the guide sheath 40 to a predetermined anchoring point with its distal end against the mitral annulus. During assembly of the anchor assembly 12 to the distal end of the delivery sheath 32, the retaining wire (i.e., the stopper 34) is pulled and moved proximally to open the opening of the through-channel 322, so that the connector 126 of the anchor assembly 12 enters the through-channel 322 and then releases the retaining wire, which is reset to close the opening of the through-channel 322.

A fourth step of implanting the first anchor assembly 12 at the mitral annulus using the anchor device 20 threaded through the lumen of the delivery sheath 32, as shown in fig. 23 and 24; the wire is then pulled so that it moves proximally to open the opening of channel 322, and the delivery sheath 32 is withdrawn proximally to completely disengage the first anchor assembly 12 from the delivery sheath 32, releasing the anchoring device 20 from the first anchor assembly 12.

Fifth, as shown in fig. 20, after implantation of the first anchor assembly 12, the anchoring device 20 and delivery sheath 32 are withdrawn, and the spacer 16 is introduced into the guiding sheath 40 through the delivery member 36; the delivery member 36 is then passed proximally through the threading ring 128 of the second anchor assembly 12 (the second anchor assembly 12 having been attached to the distal end of the anchoring device 20 and threaded through the delivery sheath 32) and the delivery sheath 32 is advanced within the guide sheath 40, and the first spacer 16 and the second anchor assembly 12 are delivered along the delivery member 36 by advancing the delivery sheath 32 to be threaded over the cinch line 14 and delivered adjacent the mitral valve annulus, with the spacer 16 interposed between the first anchor assembly 12 and the second anchor assembly 12. As shown in fig. 25, the second anchor assembly 12 is implanted under ultrasound and Digital Subtraction Angiography (DSA) by controlling the guiding sheath 40 and the delivery sheath 32 to adjust the position of the second anchor assembly 12 according to the size of the diseased mitral valve annulus.

Sixth, the fifth step is repeated, sequentially implanting the anchor assemblies 12 and spacers 16 from anterior to posterior trigones of the mitral valve, sequentially from posterior annulus to posterior trigones, or vice versa, such that the anchor assemblies 12 and spacers 16 are evenly distributed over the annulus of the mitral valve (as shown in fig. 26), and after a sufficient number of anchor assemblies 12 have been implanted, withdrawing the anchor devices 20 and delivery sheath 32.

Seventh, the proximal end of delivery member 36 is first passed through wire collector 18 at the distal end of adjustment device 60, and wire collector 18 is fed along delivery member 36 onto takeup wire 14 (as shown in FIG. 27); then, the rotating tube 64 of the adjusting device 60 is rotated forward to rotate the spool 184 of the wire collector 18 to wind the tightening wire 14, so as to adjust the length of the tightening wire 14 on the mitral valve annulus to reduce the spacing between the plurality of anchor assemblies 12, thereby contracting the mitral valve annulus. After a good ring-contracting effect is achieved, the rotating tube 64 stops rotating, the wire-rewinding device 18 locks the wire 14, the threaded rod 62 is reversed, the wire-rewinding device 18 is disengaged from the adjustment device 60 to withdraw the adjustment device 60, and the implant 10 is left on the mitral valve annulus (as shown in fig. 1), completing the ring-contracting operation. When the winding shaft 184 of the winding device 18 winds the takeup wire 14, it is necessary to avoid winding the connection between the feeding member 36 and the takeup wire 14 on the winding shaft 184, so as to avoid the feeding member 36 being unable to withdraw smoothly.

It will be appreciated that the transcatheter ring reduction system provided herein may also be applied to tricuspid annuloplasty. The use and operation of the transcatheter retraction system according to the embodiments of the present application will be described with reference to fig. 2, 20, 22-25 and 28-30, by way of example, as applied to tricuspid annuloplasty. Wherein, the operation path is as follows: transfemoral-inferior vena cava-Right Atrium (RA) -annulus of Tricuspid Valve (TV).

In a first step, transfemoral puncture is performed to establish the orbit of the femoral vein-inferior vena cava-right atrium-tricuspid annulus via a guide wire (not shown).

In a second step, as shown in fig. 28, the guiding sheath 40 is advanced over the guide wire until its distal end reaches the left atrium and reaches the vicinity of the tricuspid annulus, and the guide wire is withdrawn.

Third, as shown in FIG. 22, the thimble 128 of the first anchor assembly 12 is coupled to the distal end of the tensioning line 14 and the proximal end of the tensioning line 14 is removably coupled to the distal end of the delivery member 36. First, the first anchor assembly 12 is detachably connected to the anchoring device 20 and mounted to the distal end of the delivery sheath 32, wherein the threading ring 128, the tensioning wire 14 and the delivery member 36 of the first anchor assembly 12 are positioned outside the delivery sheath 32; the delivery sheath 32 is then moved axially distally in the guide sheath 40 to a predetermined anchoring point with its distal end against the tricuspid annulus. During assembly of the anchor assembly 12 to the distal end of the delivery sheath 32, the retaining wire (i.e., the stopper 34) is pulled and moved proximally to open the opening of the through-channel 322, so that the connector 126 of the anchor assembly 12 enters the through-channel 322 and then releases the retaining wire, which is reset to close the opening of the through-channel 322.

A fourth step of implanting the first anchor assembly 12 at the tricuspid annulus using the anchor device 20 threaded through the lumen of the delivery sheath 32, as shown in fig. 23 and 24; the wire is then pulled so that it moves proximally to open the opening of the channel 322 and then the delivery sheath 32 is withdrawn proximally to completely disengage the first anchor assembly 12 from the delivery sheath 32 and disconnect the anchoring device 20 from the first anchor assembly 12.

Fifth, as shown in fig. 20, after implantation of the first anchor assembly 12, the anchoring device 20 and delivery sheath 32 are withdrawn, and the spacer 16 is introduced into the guiding sheath 40 through the delivery member 36; the delivery member 36 is then passed proximally through the threading ring 128 of the second anchor assembly 12 (the second anchor assembly 12 having been attached to the distal end of the anchoring device 20 and threaded through the delivery sheath 32) and the delivery sheath 32 is advanced within the guide sheath 40, and the first spacer 16 and the second anchor assembly 12 are delivered along the delivery member 36 by advancing the delivery sheath 32 to be threaded over the cinch line 14 and delivered adjacent the tricuspid annulus, with the spacer 16 interposed between the first anchor assembly 12 and the second anchor assembly 12. As shown in fig. 25, the second anchor assembly 12 is implanted under ultrasound and digital subtraction angiography equipment with the guiding sheath 40 and the delivery sheath 32 controlled to adjust the position of the second anchor assembly 12 according to the size of the diseased tricuspid annulus.

In a sixth step, the fifth step is repeated, and the anchor assembly 12 and spacer 16 are sequentially implanted from the anterior septal junction of the tricuspid valve along the anterior valve annulus, posterior valve annulus to posterior septal junction, or vice versa, such that the anchor assembly 12 and spacer 16 are uniformly distributed over the tricuspid valve annulus (as shown in fig. 29), and after a sufficient number of anchor assemblies 12 have been implanted, the anchor device 20 and delivery sheath 32 are withdrawn.

Seventh, the proximal end of delivery member 36 is first passed through wire takeup 18 at the distal end of adjustment device 60, and wire takeup 18 is fed along delivery member 36 onto takeup wire 14 (as shown in FIG. 30); then, the rotating tube 64 of the adjusting device 60 is rotated forward to rotate the spool 184 of the wire collector 18 to wind the tightening wire 14, thereby adjusting the length of the tightening wire 14 on the tricuspid annulus to decrease the spacing between the plurality of anchor assemblies 12, which in turn causes the tricuspid annulus to contract. After a good ring-contracting effect is achieved, the rotating tube 64 stops rotating, the wire drawer 18 locks the tightening wire 14, and the threaded rod 62 is reversed to disengage the wire drawer 18 from the adjustment device 60 to facilitate withdrawal of the adjustment device 60, leaving the implant 10 in place on the tricuspid annulus (as shown in fig. 2), completing the ring-contracting operation.

It should be noted that there is a lower probability of crimping during implantation of the anchor assembly 12, and that the drive tube 22 of the anchor assembly 20 may be rotated in the opposite direction to unscrew the anchor assembly 12, which allows the cinch line 14 to be removed, in conjunction with the ultrasound and DSA instruments, and then the anchor assembly 12 may be retightened for implantation.

In addition, the transcatheter ring contracting system provided by the application can also be used for implanting a plurality of anchoring assemblies 12 which are connected in series through the tightening lines 14 into heart tissues such as the left ventricle wall or the right ventricle wall, and the like, and the spacing between the plurality of anchoring assemblies 12 is reduced through tightening the tightening lines 14, so that the heart chambers are reduced through narrowing the heart chambers to achieve the purpose of reducing the mitral valve annulus or the tricuspid valve annulus, and the treatment of mitral regurgitation or tricuspid regurgitation is realized. That is, the implant 10 may be implanted under the annulus, i.e., the implant 10 may also be implanted under the left ventricular wall under the mitral annulus or the right ventricular wall under the tricuspid annulus, in addition to being implanted directly on the annulus on the atrial side. Among other things, implantation of implant 10 on the left ventricular wall is particularly useful in treating heart failure due to left ventricular dysfunction and functional mitral regurgitation. Specifically, the guiding sheath 40 can be punctured from the femoral artery, retrograde passed through the aortic valve into the left ventricle, the implant 10 is implanted on the left ventricle wall through the delivery device 30 and the anchoring device 20, the tightening wire 14 is tightened to directly inhibit the left ventricle from expanding and achieve the purpose of reducing the mitral valve annulus, and this annuloplasty can retain the natural structure of the mitral valve. That is, the transcatheter ring-contracting system of the present application may be used to reduce the ventricular volume in ventricular volume reduction in addition to contracting the valve annulus in annuloplasty, and the specific process of using the transcatheter ring-contracting system is substantially similar to that of mitral valve annuloplasty or tricuspid valve annuloplasty, which will not be described herein again.

In summary, the transcatheter retraction loop system of the present application can be used to anchor a plurality of anchor assemblies 12 connected in series by tightening wires 14 to heart tissue such as mitral valve annulus, tricuspid valve annulus, left ventricular wall, right ventricular wall, etc., and the tightening wires 14 can be used to reduce the distance between the plurality of anchor assemblies 12, thereby achieving treatment of heart failure caused by mitral regurgitation, tricuspid valve regurgitation or left ventricular dysfunction.

In the description herein, reference to the description of the terms "some embodiments," "exemplary embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

While embodiments of the present application have been shown and described, it will be understood by those of ordinary skill in the art that: numerous changes, modifications, substitutions and alterations can be made to the embodiments without departing from the principles and spirit of the application, the scope of which is defined by the claims and their equivalents.

Claims

1. An anchor assembly, comprising:

an anchor for anchoring into a target tissue;

the connecting piece is sleeved on the anchoring piece; and

the threading ring is movably connected with the connecting piece and provided with a first rotating shaft perpendicular to the central shaft of the anchor, and the threading ring rotates around the first rotating shaft to be close to or far away from the anchor.

2. The anchor assembly of claim 1, wherein the connecting member defines a connecting aperture having a central axis perpendicular to a central axis of the anchor, the thimble is movably coupled to the connecting member through the connecting aperture, and the first rotational axis is coaxial with or parallel to the central axis of the connecting aperture.

3. The anchor assembly of claim 2, wherein the connector further defines a mounting hole having a central axis that is coaxial with or parallel to a central axis of the anchor, the anchor including an anchor portion and an anchor seat connected to a proximal end of the anchor portion, the anchor seat being received in the mounting hole.

4. An anchor assembly as defined in claim 3, wherein the thimble has a reference plane parallel to or coincident with the plane of the mounting aperture, the maximum angle of rotation of the thimble from the reference plane about the first axis of rotation being greater than or equal to 90 °.

5. The anchor assembly of claim 3 wherein the grommet further includes a second axis of rotation, the second axis of rotation being perpendicular to both the central axis of the anchor and the central axis of the attachment aperture, the cable being rotatable about the second axis of rotation to incline the plane of the grommet relative to the plane of the attachment aperture.

6. The anchor assembly of claim 5 wherein the thimble has a reference plane parallel to or coincident with the plane of the mounting hole, the thimble being rotatable from the reference plane about the second axis of rotation through a maximum angle in the range of 30 ° to 45 °.

7. An anchor assembly as defined in any one of claims 3 to 6, wherein said anchor block is movably received in said mounting hole, and said connector has rotational freedom to rotate about a central axis of said anchor.

8. The anchor assembly of claim 7, wherein the anchor base includes a base body, a support block, and a support portion disposed between the base body and the support block, the base body, the support portion, and the support block forming a connecting slot, the connecting member being movably sleeved on the support portion, the connecting member being at least partially received in the connecting slot.

9. An implant, wherein the implant comprises a cinch cord and a plurality of anchor assemblies as claimed in any one of claims 1 to 8, the plurality of anchor assemblies being connected by the cinch cord;

the distal end of the cinch wire is attached to the loop of the first of the anchor assemblies for anchoring into the target tissue, and the proximal end of the cinch wire is slidably threaded through the loops of the other anchor assemblies for anchoring into the target tissue.

10. The implant of claim 9, further comprising at least one spacer threaded onto the cinch wire, the spacer positioned between the two anchor assemblies.

11. The implant of claim 9 or 10, further comprising a wire retractor, the wire retractor comprising a housing and a spool rotatably disposed within the housing, a proximal end of the takeup wire movably passing through the housing and the spool, the spool rotating relative to the housing to wind the takeup wire, the takeup wire being fixed in a radial space between the spool and the housing when the spool stops rotating.

12. A transcatheter retraction system comprising an anchoring device, a delivery device and an implant according to any one of claims 9 to 11, the delivery device comprising a delivery sheath, the anchoring element being removably attached to a distal end of the anchoring device and threaded therethrough, the delivery sheath being adapted to deliver the anchoring element and the cinch wire to the target tissue, the anchoring device being adapted to drive the anchoring element into the target tissue.

13. The transcatheter retraction ring system according to claim 12, wherein the wall of the delivery sheath defines a channel extending proximally from the distal end, the channel communicating with the lumen of the delivery sheath, the channel having an opening at a distal end thereof.

14. The transcatheter retraction ring system according to claim 13, wherein the connector is provided with a retaining end, the thimble is movably connected to the retaining end, the retaining end has a radial width adapted to a radial width of the through slot, and the retaining end is axially movably retained in the through slot.

15. The transcatheter retraction system according to claim 14, wherein the capture end is provided with a guiding bevel projecting proximally in an axial direction of the anchor.

16. The transcatheter retraction system according to any one of claims 13-15, wherein the delivery device further comprises a stop movably arranged at a distal end of the delivery sheath, the stop being adapted to close the opening.

17. The transcatheter retraction ring system according to claim 16, wherein a proximal end of the stopper extends in an axial direction of the delivery sheath, and a distal end of the stopper fits a circumference of the delivery sheath and closes the opening when not subjected to an external force.

18. The transcatheter retraction system according to claim 12, wherein the delivery device further comprises a delivery member, a distal end of the delivery member being connected to a proximal end of the cinch wire.

19. The transcatheter ring reduction system of claim 12, wherein the target tissue includes a mitral valve annulus, a tricuspid valve annulus, a left ventricular wall, and a right ventricular wall.

20. Use of the transcatheter retraction system according to any one of claims 12-19 for contracting an annulus in an annuloplasty procedure or for reducing a ventricular volume in a ventricular volume reduction procedure.