WO2023029726A1 - Anchor assembly having threading ring, implant, and transcatheter ring contraction system - Google Patents

Abstract

An anchor assembly (34) having a threading ring (347), an implant (30), and a transcatheter ring contraction system (1). The anchor assembly (34) comprises an anchor member (340), a connection member (345), and the threading ring (347). The anchor member (340) is used for anchoring into human tissue. The connection member (345) is movable sleeved on the anchor member (340), the connection member (345) has at least two degrees of freedom, and one degree of freedom of the connection member (345) is a rotational degree of freedom for the connection member (345) to rotate around a central axis (Z) of the anchor member (340). The threading ring (347) is movably connected to the connection member (345). The anchor assembly (34) uses the connection member (345) having at least two degrees of freedom and the threading ring (347); the threading ring (347) connected to a tightening line (32) has a large range of motion, and can reduce the resistance of the tightening line (32) during the contraction process and ensure the stability of ring contraction; and each anchor assembly (34) is subjected to uniform force, which reduces the risk of valve damage and anchor assembly (34) falling off, and makes implantation safer.

Description

Anchoring assembly with threading loop, implant and transcatheter shrinking loop system

This application claims the priority of the Chinese patent application with the application number 202111031389.2 and the application title "Anchor assembly with threading ring, implant and transcatheter ring shrinking system" submitted to the Chinese Patent Office on September 3, 2021 , the entire contents of which are incorporated in this application by reference.

technical field

The present application relates to the technical field of medical devices, in particular to an anchoring assembly with a threading ring, an implant and a transcatheter shrinking ring system.

Background technique

Mitral regurgitation (abbreviation: MR) is a common heart valve disease, including primary mitral regurgitation and secondary mitral regurgitation. Primary mitral regurgitation is due to abnormal mitral valve leaflets, chordal rupture or papillary muscle insufficiency leading to poor anastomosis of the anterior and posterior leaflets of the mitral valve, and secondary mitral regurgitation is due to annulus dilatation, left atrium And left ventricular enlargement leads to poor anastomosis of the anterior and posterior mitral valve leaflets.

In recent years, mitral valve interventional therapy has developed rapidly, mainly including valve repair or valve replacement. Among them, mitral annuloplasty is a common repair procedure, which reduces mitral regurgitation by reducing the size of the patient's valve annulus.

In the prior art, multiple anchors are sequentially implanted at different positions of the mitral valve annulus through a transcatheter route, and multiple anchors fixed at different positions of the valve annulus are connected in series by tightening wires. Tighten to tighten the annulus circumferentially, thereby relieving mitral regurgitation. The seat at the proximal end of the anchor is provided with a threading hole for the tightening wire to pass through so that the tightening wire can connect multiple anchors in series. However, when the anchors are implanted, it cannot be guaranteed that the orientation of the threading holes of each anchor is along the circumferential direction of the annulus. If the orientation of the threading holes between the anchors is not along the circumferential direction of the annulus, the When the tightening line is pulled, the tightening line will be bent and subjected to greater resistance, which is not conducive to the stability of the shrinking ring and affects the effect of the shrinking ring. In addition, since most of the resistance received by the tightening wire acts on the anchor connected to it, and the force of the anchor will act on the valve, causing the risk of damage to the valve when the wire is retracted. At the same time, because part of the anchors are subjected to a large tightening force, and because the direction of the threading holes of each anchor is uncontrollable and inconsistent with each other, the force on each anchor is uneven, and a single anchor is likely to appear. The applied tightening force is relatively large, leading to the risk of the anchor falling off.

technical problem

The purpose of this application is to provide an anchoring component with a threading ring, an implant and a transcatheter shrinking ring system to solve the problems that the tightening wire is blocked, affects the stability of the shrinking ring, and easily causes valve damage and the anchoring component falls off. .

technical solution

In a first aspect, the present application provides an anchoring assembly with a threading ring, including: an anchoring piece, the anchoring piece is used to anchor into human tissue; a connecting piece, the connecting piece is movably sleeved on the anchoring piece On the part, the connecting part has at least two degrees of freedom, one of the degrees of freedom of the connecting part is the rotational degree of freedom that the connecting part rotates around the central axis of the anchor part; and the threading ring, the The threading ring is flexibly connected with the connecting piece.

In the second aspect, the present application also provides an implant for contracting heart tissue, the implant includes a tightening wire and a plurality of the above-mentioned anchoring components with threading loops, and a plurality of the anchoring components pass through the The tightening wires are connected and respectively anchored into the heart tissue; the distal end of the tightening wire is connected to the threading ring of the first anchoring assembly for anchoring into the heart tissue, and the proximal end can slide through A threaded loop for the other of said anchoring components anchored into said cardiac tissue.

In a third aspect, the present application also provides a transcatheter ring shrinkage system, including an anchoring device and the above-mentioned implant, the anchoring device includes a driving tube and a connecting rod inserted in the driving tube, and the The proximal end of the anchor is provided with a first connecting portion, the distal end of the drive tube is provided with a second connecting portion detachably connected to the first connecting portion, and the connecting rod is axially passed through the matingly connected The first connecting portion and the second connecting portion keep the anchoring assembly connected to the anchoring device, and the driving tube is used to drive the anchoring member to be anchored into the annulus.

In the fourth aspect, the present application also provides an application of the above-mentioned transcatheter ring shrinkage system, which is used to shrink the valve ring in annuloplasty, or reduce the Ventricular volume.

Beneficial effect

In the anchoring assembly, the implant, and the transcatheter shrinking ring system provided by the present application, since the anchoring assembly adopts a connector with at least two degrees of freedom, the threading ring is movably connected to the connector, so that the threading ring The range of motion is large. When the tightening wire is connected in series with multiple threading loops of the anchoring components implanted in the heart tissue and tightened, the threading ring can move to cooperate with the tightening wire under the action of the tightening force of the tightening wire. In the tight state, the threading direction of the threading ring can follow the circumferential direction of the heart tissue, which greatly reduces the resistance of the tightening line during the contraction process. There is no bending of the tightening line and the contraction is stable and smooth, ensuring contraction The stability of the ring or narrowed ventricle works well. Furthermore, since the resistance of the tightening wire in the tightening direction is greatly reduced, the tightening force is reduced and the force of the tightening force distributed on each anchor component is more uniform, so that each anchor component suffers The tightening force is greatly reduced, which reduces the force of the anchoring component on the heart tissue and reduces the risk of damage to the heart tissue; at the same time, it avoids the situation that the tightening force of a single anchoring component accounts for a large proportion, reducing the anchoring force. The risk of detachment of components is reduced, and the implantation is safer.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the accompanying drawings used in the embodiments. Obviously, the accompanying drawings in the following description are some implementations of the present application, which are common to those skilled in the art. As far as the skilled person is concerned, other drawings can also be obtained based on these drawings on the premise of not paying creative work.

Fig. 1 is a schematic structural diagram of a transcatheter ring shrinking system provided by the first embodiment of the present application.

Fig. 2 is a schematic diagram of the implant provided in the first embodiment of the present application being implanted into the valve annulus and the tightening wire is not tightened.

Fig. 3 is a schematic diagram of the tightening line in Fig. 2 after being tightened.

Fig. 4 is a schematic perspective view of the anchor assembly in Fig. 1 .

Fig. 5 is a schematic perspective view of the three-dimensional structure of the anchor seat in Fig. 4 .

Fig. 6 is a schematic diagram of the connecting member in Fig. 4 turning upwards around the first radial axis.

FIG. 7 is a schematic view of the connecting member in FIG. 4 turning downward around the first radial axis.

FIG. 8 is a schematic view of the threading in FIG. 4 going right around the third radial axis.

FIG. 9 is a schematic view of the threading in FIG. 4 rotating upward around the third radial axis.

Fig. 10 is a schematic diagram of the connection between the anchoring assembly and the anchoring device in Fig. 1 .

Fig. 11 is a schematic diagram of separation of the anchoring assembly and the anchoring device in Fig. 10 .

Fig. 12 is an axial cross-sectional view of the anchor assembly in Fig. 10 when it is connected to the anchor device.

Fig. 13 is a schematic diagram of the connection between the anchoring assembly and the tightening wire of the first implanted annulus in the implant in Fig. 2 .

Fig. 14 is a schematic diagram of the pusher pushing the spacer.

Figure 15 is a perspective view of the delivery device, anchoring device, anchor assembly, tightening wire and spacer threaded within the introducer.

Fig. 16 is an axial sectional view of the connection between the wire take-up and the distal end of the adjustment device.

FIG. 17 is a perspective view of the three-dimensional structure of the winding shaft and bottom case of the wire take-up in FIG. 16 .

FIG. 18 is a schematic perspective view of the three-dimensional structure of the winding shaft in FIG. 17 .

FIG. 19 is a schematic perspective view of the bottom case in FIG. 17 .

20 to 22 are perspective views of the use process of the transcatheter ring shrinking system provided by the first embodiment of the present application.

Fig. 23 is a schematic perspective view of the anchoring assembly provided by the second embodiment of the present application.

24 is an axial cross-sectional view of the anchor assembly of FIG. 23 .

FIG. 25 is a schematic perspective view of the connecting piece in FIG. 23 .

Fig. 26 is a schematic three-dimensional structure diagram of the anchor assembly provided by the third embodiment of the present application.

Fig. 27 is a schematic view of the anchor assembly in Fig. 26 after being anchored into the valve annulus.

Embodiments of the present invention

The following will clearly and completely describe the technical solutions in the embodiments of the present application with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of them. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

In addition, the following descriptions of the various embodiments refer to the attached drawings to illustrate specific embodiments that the application can be used to implement. The directional terms mentioned in this application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., only is to refer to the direction of the attached drawings. Therefore, the direction terms used are for better and clearer description and understanding of the application, rather than indicating or implying that the device or element referred to must have a specific orientation, and must have a specific orientation. construction and operation, therefore should not be construed as limiting the application.

It should be noted that, in order to more clearly describe the structure of the anchor assembly with threading ring, the implant and the transcatheter retraction system provided by the present application, the limited terms "proximal" and "proximal end" described in the specification of the present application Distal" is a commonly used term in the field of interventional medicine. Specifically, "distal end" means the end far away from the operator during the surgical operation, and "near end" means the end close to the operator during the surgical operation; Defined as the axial direction; the circumferential direction is the direction around the axis of objects such as cylinders and tubes (perpendicular to the axis and perpendicular to the section radius); the radial direction is the direction along the diameter or radius. It is worth noting that regardless of "near end", "distal end", "one end", "another end", "first end", "second end", "initial end", "end end", "both ends" , "free end", "upper end", "lower end" and other words, "end" is not limited to the end, end point or end face, but also includes from the end, end point, or end face at the end, end point, or The portion of the element to which the end face belongs extends an axial distance and/or a radial distance. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the technical field to which this application belongs. The conventional terms used in the description of the present application are only for the purpose of describing specific embodiments, and should not be construed as limiting the present application.

Please refer to FIG. 1 to FIG. 3 together. The present application provides a transcatheter ring shrinkage system 1 for shrinking heart tissue such as mitral valve ring or tricuspid valve ring to reduce blood regurgitation. Specifically, the transcatheter ring shrinkage system 1 includes an anchoring device 10 , an implant 30 , a delivery device 50 and a guiding device 70 . Wherein, the implant 30 includes a tightening wire 32 and a plurality of anchoring components 34, each anchoring component 34 has a threading ring 347 for connecting the tightening wire 32, and the multiple anchoring components 34 pass through the tightening wire 32. Connect and anchor into the valve annulus through the anchoring device 10 in turn. It should be noted that, as shown in FIGS. 2 and 3 , the distal end of the tightening wire 32 is connected to the threading ring 347 of the first anchoring component 34 for anchoring into the annulus, and the proximal end can slide through for anchoring. The threading ring 347 of the other anchoring assembly 34 of the annulus.

As shown in FIG. 1 , the delivery device 50 includes a delivery sheath 52 and a delivery wire 54, the delivery wire 54 is connected to the tightening wire 32, and each anchoring component 34 is detachably connected to the distal end of the anchoring device 10 and passed through the delivery wire. 51 is connected with the tightening wire 32, the anchoring device 10, the anchoring assembly 34, the tightening wire 32 and the delivery line 54 are put through the delivery sheath 52 together, and the anchoring device 10, the anchoring assembly 34, The delivery sheath 52 of the tightening wire 32 and the delivery wire 54 is passed through the introducer 70 . When using the transcatheter ring shrinkage system 1 to shrink the ring, first establish an intervention channel from the outside of the patient's body to the valve annulus through the guide device 70, and then put the anchor device 10, anchor assembly 34, tightening wire 32 and The delivery sheath 52 of the delivery wire 54 is moved axially and distally in the guide device 70 to abut against the valve annulus, and then the anchor assembly 34 is anchored into the valve annulus in the delivery sheath 52 through the anchor device 10 , a plurality of anchoring assemblies 34 are sequentially anchored into different positions along the circumference of the annulus through the same steps described above (as shown in FIG. 2 ), and finally the tightening wire 32 is tightened so that the plurality of anchoring assemblies 34 are relatively gathered together. To reduce the distance between multiple anchoring components 34 (as shown in FIG. 3 ), thereby driving the annulus to shrink and achieve the purpose of shrinking the annulus.

Among them, it needs to be emphasized that, unlike the anchor member in the prior art that connects the tightening wire through a threading hole, the anchor assembly 34 provided by the present application uses a freely movable threading ring 347 to connect the tightening wire 32, thereby ensuring the tightening The stability of the ring, to achieve a good ring shrinkage effect.

Specifically, please refer to FIG. 4 and FIG. 5 , the anchoring component 34 includes an anchoring part 340 , a connecting part 345 and a threading ring 347 . Wherein, the anchor 340 is used for anchoring into human tissue such as valve annulus. The connecting piece 345 is movably sleeved on the anchoring piece 340 . The connecting piece 345 has at least two degrees of freedom, one of which is a rotational degree of freedom for the connecting piece 345 to rotate around the central axis A of the anchoring piece 340 . The threading ring 347 is movably connected with the connecting piece 345 .

It can be understood that in the anchor assembly 34 provided by the present application, since the connecting member 345 has at least two degrees of freedom, the threading ring 347 is movably connected with the connecting member 345, so that the moving range of the threading ring 347 is large, and multiple implanted valves The anchor assembly 34 of the ring is respectively connected to the tightening wire 32 through the threading ring 347. When the tightening wire 32 is tightened, the threading ring 347 of the anchoring assembly 34 can move to the mating tightening under the effect of the tension force of the tightening wire 32. In the state after the tightening wire 32 is tightened, the threading ring 347 of each anchoring component 34 can be moved so that the threading direction is along the circumferential direction of the annulus, thereby greatly reducing the resistance of the tightening wire 32 during the contraction process, The tightening wire 32 does not have any bending and shrinks stably and smoothly, thereby ensuring the stability of the shrinking ring, and the ring shrinking effect is good. Furthermore, since the resistance of the tightening wire 32 in the tightening direction is greatly reduced, the tightening force is reduced and the force of the tightening force distributed on each anchor component 34 is more uniform, so that each anchor component 34 greatly reduces the tightening force, reduces the force of each anchoring component 34 on the valve, reduces the risk of valve damage, and avoids the phenomenon that the tightening force of a single anchoring component 34 accounts for a large proportion situation, the risk of anchoring component 34 falling off is reduced, and the implantation is safer. Preferably, the threading loop 347 has at least two degrees of freedom.

In the first embodiment of the present application, as shown in FIG. 4 , the connecting member 345 includes a first radial axis B and a second radial axis C perpendicular to each other, and both the first radial axis B and the second radial axis C are perpendicular to the central axis A of the anchor 340 . The connecting part 345 has four degrees of freedom, which are the rotational degree of freedom of rotating around the central axis A of the anchoring part 340, the translational degree of freedom of moving axially along the anchoring part 340, and the rotational degree of rotating around the first radial axis B. degrees of freedom, translational degrees of freedom for movement along the second radial axis C.

In this embodiment, the anchoring member 340 includes an anchoring portion 341 and an anchoring seat 343 connected to a proximal end of the anchoring portion 341 . The anchoring portion 341 is used for anchoring into human tissue. The anchor seat 343 is used for detachably connecting the anchor device 10 . When the anchoring component 34 and the tightening wire 32 are applied to shrink the valve annulus, the human tissue is heart tissue, including mitral valve ring, tricuspid valve ring and the like. The anchoring assembly 34 introduced in this application is mainly used in the transcatheter ring shrinkage system 1 , so the following description mainly takes human tissue as the valve ring.

Furthermore, the outer wall of the anchor seat 343 defines a connecting groove 3435 along the circumference, and the connecting piece 345 is movably sleeved on the anchor seat 343 and partially accommodated in the connecting groove 3435 . Specifically, the anchoring base 343 includes a support portion 3433 , a first connecting portion 3431 disposed at a proximal end of the support portion 3433 , and an insertion portion 3437 disposed at a distal end of the support portion 3433 . The first connecting portion 3431 can be detachably connected to the anchoring device 10 . The inserting portion 3437 is connected to the proximal end of the anchoring portion 341 . In order to ensure that the anchor 340 can be received in the delivery sheath 52 and has a certain connection strength, the support part 3433 is usually a tubular structure, and the outer diameter of the support part 3433 is larger than the outer diameter of the first connecting part 3431 and the insertion part. The outer diameter of 3437 , that is, the outer diameter of the support part 3433 is the maximum outer diameter of the anchoring seat 343 . The connecting member 345 is a connecting ring movably sleeved on the supporting portion 3433 of the anchoring seat 343 , and the connecting ring is partially accommodated in the connecting groove 3435 and directly buckled and connected with the threading ring 347 .

Certainly, in other embodiments, the connecting member 345 may be another annular structure with four degrees of freedom, and the connecting member 345 is indirectly connected with the threading ring 347 . The connecting part 345 can also be movably sleeved on the proximal end of the anchoring part 341, and the anchoring part 341 is designed as a helical anchor or a stopper is designed on the anchoring part 341 so that the connecting part 345 does not fall off from the anchoring part 340 just drop.

As shown in FIG. 5 , the supporting portion 3433 of the anchoring seat 343 is roughly in the shape of an “I” shape, and a connecting groove 3435 is formed around the outer wall of the supporting portion 3433 . The first connecting portion 3431 is used for detachable connection with the distal end of the anchoring device 10 . The insertion part 3437 is provided with an insertion hole extending in the axial direction of the anchoring part 340, and the proximal end of the anchoring part 341 is inserted into the insertion hole and fixed by welding or gluing. In other embodiments, the anchoring portion 341 can be directly fixedly connected to the insertion portion 3437 by welding or the like, and the insertion portion 3437 does not need to have an insertion hole. The anchoring part 341 can also be fixedly connected to the distal end of the supporting part 3433 directly by means of welding or the like, so that the insertion part 3437 does not need to be provided.

As shown in FIG. 4 , the anchoring part 341 of the anchoring assembly 34 is a helical anchor, and the helical anchor has a tip, which is easy to be implanted into the annulus or other tissues, and the implantation is stable. Although the anchoring portion 341 herein is exemplified as a helical anchor, in other embodiments, the anchoring portion 341 may be another suitable shape that enables the anchoring portion 341 to engage with and substantially fix to human tissue. constructions such as but not limited to barbs, hooks, tines, etc.

Please refer to Fig. 4 again, the inner diameter of the connecting ring is larger than the maximum outer diameter of the anchor seat 343 (ie the outer diameter of the support part 3433), and smaller than the maximum outer diameter of the anchor seat 343 (ie the outer diameter of the support part 3433) and the threading The sum of the minimum radial thicknesses of ring 347. Thus, the connecting ring will not slip out of the connecting groove 3435 and fall off from the supporting portion 3433 of the anchoring seat 343 . It should be noted that the radial thickness of the threading ring 347 can be consistent or inconsistent, and the uniform thickness can improve the strength and service life of the threading ring 347, while the inconsistent thickness makes the threading ring 347 have better degrees of freedom, which can be selected according to actual needs. That's it. When the radial thickness of the whole threading ring 347 is consistent, the outer diameter of the threading ring 347 minus 1/2 of the difference of its inner diameter is the radial thickness of the threading ring 347, that is, the minimum radial thickness of the threading ring 347.

Along the axial direction of the anchor seat 343 , the axial width p of the connecting groove 3435 is greater than the axial thickness of the connecting ring. That is to say, there is a gap between the connecting groove 3435 and the connecting ring. Thus, the connecting ring can also move along the axial direction of the anchor seat 343 , that is, the degree of freedom of the connecting ring includes the translational degree of freedom of moving along the central axis A of the anchor 340 (ie, the axial direction of the anchor 340 ). The axial thickness of the connecting ring, that is, the thickness of the connecting ring along its axial direction.

It can be understood that the threading ring 347 is directly interlocked with the connecting ring so that the central axis of the connecting ring is offset from the central axis A of the anchor 340, and there is a gap in the radial direction between the connecting ring and the anchor seat 343. The ring can rotate 360 degrees around the central axis A of the anchor 340 , that is, the degree of freedom of the connecting ring includes the rotational degree of freedom of rotation around the central axis A of the anchor 340 . Furthermore, since there is a gap between the connecting groove 3435 and the connecting ring along the axial direction of the anchor member 340, the connecting ring can rotate around the first radial axis B, that is, the degree of freedom of the connecting ring includes rotating around the first radial axis B. Rotational degrees of freedom for axis B rotation. Specifically, please refer to FIG. 6 and FIG. 7 together. The connecting ring can rotate around the first radial axis B toward the proximal direction (the upward direction shown in FIG. 6 ) at a certain angle, or around the first radial axis B toward the The distal direction (the downward direction shown in Figure 7) is rotated by a certain angle. Wherein, by reasonably designing the size of the axial gap between the connecting groove 3435 and the connecting ring, the connection can be limited to rotate around the first radial axis B within a reasonable angle. Preferably, the ratio of the gap to the axial thickness of the connecting ring is in the range of 1/20-1/8, which can limit the small-angle deflection of the connection around the first radial axis B (for example, it can be deflected upward by 10 degrees and downward by 10 degrees). degree), that is, to deflect in the axial direction of the anchor piece 340, which is beneficial to reduce the resistance suffered by the tightening wire 32 when it is tightened, so that the shrinking ring is smoother, and at the same time, it avoids the connection ring in the axial direction of the anchor piece 340. The upper deflection angle is too large to cause the risk of the anchor assembly 34 falling off.

Further, the radial depth q of the connecting groove 3435 is greater than the radial thickness of the connecting ring and less than twice the radial thickness of the connecting ring. Thus, the connecting ring can be assembled on the connecting groove 3435 of the anchor seat 343 and the connecting ring can move on the connecting groove 3435 . The radial thickness of the connecting ring, that is, the thickness of the connecting ring along its radial direction. Since the radial depth q of the connecting groove 3435 is greater than the radial thickness of the connecting ring, the connecting ring can move along the second radial axis C, that is, the degree of freedom of the connecting ring includes the freedom of translation along the second radial axis C Spend. Similarly, by reasonably designing the difference between the radial depth q of the connecting groove 3435 and the radial thickness of the connecting ring, the connecting ring can move a certain distance along the second radial axis C. In addition, the ratio of the radial depth q of the connection groove 3435 to the maximum outer diameter of the anchor seat 343 (that is, the outer diameter of the support part 3433) is in the range of 1/8-1/4, so as to avoid the connection groove 3435 from being too deep and ensure The strength of the support part 3433.

Please refer to FIG. 4 again, the threading ring 347 includes its own central axis D, a third radial axis E parallel to the central axis A of the anchor 340, and a fourth radial axis F perpendicular to the third radial axis E. . The threading ring 347 that is movably fastened to the connecting ring also has four degrees of freedom, including the degree of freedom of rotation around its own central axis D (rotatable 360 degrees), and the freedom of rotation around the third radial axis E. degree, the rotational degree of freedom for up and down deflection around the fourth radial axis F, and the translational degree of freedom for moving along its central axis D. Among them, it can be understood that, as shown in Figures 8 and 9, since the threading ring 347 is fastened to the connecting ring, the threading ring 347 is less restricted by the anchor seat 343, and the space for movement is larger. The rotational degree of freedom of radial axis E left and right deflection is large, can reach 100 degrees (can deflect 100 degrees to the left, deflect 100 degrees to the right); Large, can reach 60 degrees (can be deflected up to 60 degrees, down to 60 degrees).

As mentioned above, in the first embodiment, the connecting member 345 (that is, the connecting ring) and the threading ring 347 of the anchoring assembly 34 have four degrees of freedom respectively. Therefore, after multiple anchoring assemblies 34 are implanted in the annulus, the connecting ring Both the connecting ring and the threading ring 347 can deflect in multiple directions, and the range of motion is large; as shown in Figure 3, when the tightening line 32 is tightened, the connecting ring and the threading ring 347 will be close to the anchor seat under the action of the tightening force 343, the threading ring 347 will be automatically adjusted to the circumferential direction, so that the tightening line 32 can smoothly form a C shape consistent with the annulus, the resistance of the tightening line 32 in the tightening direction is greatly reduced, and the tightening line 32 does not exist The bending condition and the shrinkage are stable and smooth, ensuring the stability of the shrinking ring, and the shrinking ring effect is good. In addition, since the resistance of the tightening wire 32 in the tightening direction is greatly reduced, the tightening force is reduced and the force of the tightening force distributed on each anchor component 34 is more uniform, and the corresponding single anchor component 34 The acting force is greatly reduced, which reduces the force of the anchoring component 34 on the valve, reduces the risk of valve damage, and avoids the situation that the tightening force of a single anchoring component 34 takes a large proportion, reducing the The risk of the anchor component 34 falling off, the implantation is safer.

In the anchor assembly 34, the connecting ring can be a circular ring or an elliptical ring, and the shape of its axial section can be circular or elliptical; similarly, the threading ring 347 can also be a circular ring or an elliptical ring, and its axial section can be circular or elliptical. The shape can also be circular or oval. In the first embodiment, both the connecting ring and the threading ring 347 are circular rings, and the cross-sectional shapes of both are circular.

In order to ensure safety after implantation, the anchoring component 34 is entirely made of materials with good biocompatibility, including but not limited to metal materials (such as stainless steel) or polymer materials (such as PEEK, PET). Wherein, the anchor seat 343 and the anchor portion 341 are preferably made of stainless steel with high hardness. Both the connecting ring and the threading ring 347 can be made of stainless steel material or polymer material (such as PEEK or PET). For example, the stainless steel wire can be wrapped around the support portion 3433 of the anchor seat 343, and the two ends can be fixed by spot welding or the two ends can be crimped and fixed by a sleeve to form a connecting ring, and then another stainless steel wire can be passed through. Through the connecting ring, the two ends are fixed by spot welding or the two ends are crimped and fixed by a sleeve to form a threading ring 347 . Preferably, the connecting ring and/or threading ring 347 can be made of flexible polymer material, which can be twisted and deformed, so as to facilitate its rotation.

Please refer to FIGS. 10 to 12 together. The distal end of the anchoring device 10 is detachably connected to the anchoring component 34 . Specifically, the anchoring device 10 includes a driving tube 12 and a connecting rod 14 mounted in the driving tube 12, and the distal end of the driving tube 12 is provided with a second connection that is detachably connected to the first connecting portion 3431 of the anchor base 343. part 122, the connecting rod 14 is axially passed through the first connecting part 3431 and the second connecting part 122 that are mated and connected, so that the anchoring assembly 34 is kept connected with the driving tube 12 of the anchoring device 10, and the driving tube 12 is used for Delivery and drive anchor 340 (ie, anchor portion 341 ) is anchored into the annulus.

Wherein, the first connecting part 3431 and the second connecting part 122 are connecting seats with S-shaped snap-fit curved surfaces arranged on the proximal end of the anchoring seat 343 and the distal end of the driving tube 12 respectively, and each of the connecting seats has an inner cavity . As shown in Figure 12, when the first connecting part 3431 is docked with the second connecting part 122, the respective connecting seats of the anchor seat 343 and the driving tube 12 are snapped together, and the inner cavities of the two are communicated, and the inner cavity of the two is connected to each other. The distal end of the connecting rod 14 protrudes from the distal end of the driving tube 12 and is inserted into the inner cavities of the two connecting seats, thereby limiting the separation of the first connecting part 3431 and the second connecting part 122, so that the anchor assembly 34 and the driving tube 12 remains connected, and the anchoring part 341 can be driven to rotate by rotating the driving tube 12, so that the anchoring part 341 is anchored into the valve annulus. It can be understood that when the distal end of the connecting rod 14 is withdrawn from the butt joint between the first connecting part 3431 and the second connecting part 122, the first connecting part 3431 and the second connecting part 122 can be separated, thereby realizing anchoring Separation of assembly 34 from drive tube 12 . The anchoring device 10 can be made of metal material or polymer material, preferably made of metal material with high hardness such as stainless steel.

In other embodiments, the first connecting portion 3431 and the second connecting portion 122 may be connecting portions of other structures, such as a matching structure of a locking block and a locking slot, which is not limited thereto.

In other embodiments, the anchoring device 10 can also be composed of a driving tube 12 and a connecting tube sheathed on the outside of the driving tube 12. The outside of the connection part 122 can also play a role in limiting the separation of the first connection part 3431 and the second connection part 122 .

Please refer to FIG. 1 again, the delivery device 50 includes a delivery sheath 52, the anchoring assembly 34 is detachably connected to the anchoring device 10 and the tightening wire 32 passes through the threading ring 347 of the anchoring assembly 34 and is integrally worn on the delivery sheath 52 In the present invention, the plurality of anchor components 34 of the implant 30 can be delivered to the annulus in sequence through the delivery device 50 . Wherein, as mentioned above, the threading ring 347 of the first anchoring component 34 is connected to the distal end of the tightening wire 32 .

Specifically, referring to FIG. 13 , after the tightening wire 32 passes through the threading ring 347 of the first anchor assembly 34 , the distal end of the tightening wire 32 is fixed through the crimping tube 33 , and the crimping tube 33 cannot pass through the threading ring 347 . Wherein, the pressing tube 33 can be made of a metal material with good biocompatibility (such as stainless steel) and pressed through a press, so as to fix the distal end of the tightening wire 32 . Preferably, the compression tube 33 is entirely covered by a film, so as to reduce the risk of damage to the annulus or other cardiac tissues by the compression tube 33 .

Please refer to Fig. 1 again, in the first embodiment, the introducing device 70 includes a first guiding sheath 71 and a second guiding sheath 72 worn in the first guiding sheath 71, the second guiding sheath The tube 72 can protrude from the distal end of the first guiding sheath 71 and fit on the valve annulus, so as to establish an intervention channel from the outside of the body to the valve annulus.

Preferably, both the first guiding sheath 71 and the second guiding sheath 72 are adjustable curved sheaths, so that the distal end of the guiding device 70 can be adjusted to fit the valve annulus, and the two adjustable curved The guiding sheath can better adjust the bending angle and direction of the distal end of the guiding device 70 . Of course, in other embodiments, the guiding device 70 may also only use an adjustable and curved guiding sheath. Wherein, the adjustable guiding sheath is a commonly used guiding device in interventional surgery in the prior art, and will not be described in detail here.

It should be noted that the distal end of the delivery sheath 51 is flexible, and the delivery sheath 51 is installed in the lumen of the second guiding sheath 72, and the delivery sheath can be adjusted by adjusting the bending angle of the distal end of the guiding device 70. The distal end of the tube 51 is bent so that the delivery sheath 51 fits the valve annulus accurately, so that the implantation of the anchor assembly 34 is more stable and accurate.

As mentioned above, multiple anchoring components 34 are anchored into different positions along the circumference of the annulus in turn, and by tightening the tightening wire 32 connecting multiple anchoring components 34 in series, multiple anchoring components 34 can be made relatively Gathering and narrowing the distance (as shown in Figure 3) will drive the annulus to contract and achieve the purpose of shrinking the annulus. Preferably, as shown in FIGS. 2 and 3 , the implant 30 further includes at least one spacer 36 , the spacer 36 is worn on the tightening wire 32 , and at least one spacer 36 is located between the two anchor components 34 between. The spacer 36 can prevent the excessive tightening of the tightening wire 32 from causing the distance between two adjacent anchor assemblies 34 to be too short and damage the valve annulus. The tightening force ensures that the anchoring component 34 is implanted stably. Wherein, the spacer 36 is a cylindrical member with a certain length, preferably made of a biocompatible material. The spacer 36 may be coated to reduce the risk of damage to the annulus or other cardiac tissue by the spacer 36 .

Optionally, a spacer 36 (as shown in FIGS. A spacer 36 is provided between two or more anchor components 34 , which is not limited thereto.

Please refer to FIG. 14 and FIG. 15 together, the transcatheter ring shrinkage system 1 further includes a pusher 90 for pushing the spacer 36 . Specifically, as shown in FIGS. 14 and 15 , the distal end of the pushing member 90 is provided with a threading hole 92 for the proximal end of the tightening wire 32 to move through, and the pushing member 90 pushes the spacer 36 along the tightening wire 32 to enter. In the second guiding sheath 72 , the delivery sheath 52 is passed through the second guiding sheath 72 to push the septum 36 through the second guiding sheath 72 .

It can be understood that after the first anchoring assembly 34 is implanted in the annulus, the delivery sheath 52 and the anchoring device 10 are withdrawn, the spacer 36 is inserted at the proximal end of the tightening wire 32 and the tightening wire 32 is threaded along the After the direction a passes through the threading hole 92 of the pusher 90 , the pusher 90 pushes the spacer 36 into the second guiding sheath 72 of the guiding device 70 along the tightening wire 32 along the pushing direction b. Then, the second anchoring assembly 34 is assembled with the anchoring device 10 and the tightening wire 32 passes through the threading ring 347 of the second anchoring assembly 34, and then is integrally worn in the delivery sheath 52, and the delivery sheath 52 Further threaded in the second introducing sheath 72 , the spacer 36 is located on the distal side of the delivery sheath 52 . Thus, the delivery sheath 52 moves axially and distally in the second guiding sheath 72, and the spacer 36 can be pushed to the annulus, and then the anchoring device 10 pushes the second anchoring assembly 34 out. The sheath 52 is delivered and the second anchor assembly 34 is anchored into the annulus such that the spacer 36 is positioned between the two anchor assemblies 34 . The same steps are repeated, and multiple anchor assemblies 34 are sequentially implanted into the annulus, and at the same time, the spacer 36 is inserted between every two or more anchor assemblies 34 in sequence. Wherein, the distance between two adjacent anchor assemblies 34 needs to be greater than the axial length of the spacer 36 .

Preferably, please refer to FIG. 1 to FIG. 3 again, the delivery device 50 further includes a delivery wire 54 connected to the proximal end of the tightening wire 32, and the implant 30 also includes a take-up wire for adjusting and locking the tightening wire 32 The retractor 38 through the catheter system 1 also includes an adjustment device 80 for conveying and controlling the retractor 38 . It can be understood that the distal end of the delivery wire 54 is connected to the proximal end of the tightening wire 32, and the proximal end of the delivery wire 54 extends outside the body, and the tightening wire 32 is connected to the anchor assembly 34 and the spacer 36 through the delivery wire 54 extending outside the body. , The length of the tightening line 32 can be designed to be shorter, and the length can be adjusted and locked by the wire take-up device 38, without cutting the tightening line 32. Specifically, as shown in FIG. 2 and FIG. 3 , the proximal end of the tightening wire 32 is folded in half to form a U shape, and the delivery wire 54 passes through the double fold of the tightening wire 32 to realize a detachable connection. The proximal end of the tightening wire 32 can slide through the threading ring 347 and the wire retractor 38 of other anchoring components 34 anchored into the annulus, and the tightening wire 32 is tightened and locked by the wire retractor 38 , that is, the delivery line 54 can be withdrawn, the tightening line 32 can be released, and the shrinking ring can be completed to reduce blood reflux. When the delivery line 54 is not detachably connected to the tightening line 32 , the delivery line 54 can be withdrawn from the body by cutting the delivery line 54 .

Please refer to FIGS. 16 to 19 together. The wire take-up 38 includes a housing 381 and a winding shaft 383 rotatably disposed in the housing 381 . Because the delivery line 54 is connected with the tightening line 32, the wire take-up device 38 is worn on the delivery line 54 and moves to the far end of the delivery line 54 so that the proximal end of the tightening line 32 can pass through the housing 381 and the winding shaft movably. 383 , the winding shaft 383 rotates relative to the casing 381 to wind the tightening wire 32 , when the winding shaft 383 stops rotating, the tightening wire 32 is locked in the radial space between the winding shaft 383 and the casing 381 .

The adjusting device 80 includes a threaded rod 82 , a rotating shaft 84 and an outer sheath 86 arranged from inside to outside. The threaded rod 82 is used to thread the winding shaft 383, the rotating shaft 84 is used to engage the rotating shaft 84 and drive the winding shaft 383 to rotate relative to the housing 381, and the outer sheath 86 is engaged with the housing 381 to fix the housing 381 , to prevent the casing 381 from rotating together with the winding shaft 383 .

Specifically, as shown in FIG. 16 , the housing 381 includes a hollow shell 3812 with an open distal end, a bottom shell 3814 connected and encapsulated in the open distal end of the shell 3812 , and engaging teeth 3816 protruding from the proximal end of the shell 3812 , The outer shell 3812 and the bottom shell 3814 surround and form an accommodating cavity for placing the winding shaft 383, wherein a through hole communicating with the accommodating cavity is opened at the proximal end of the outer shell 3812, and the engaging teeth 3816 are arranged at intervals along the circumference of the through hole. The sidewall of the housing 3812 is provided with a pair of first threading holes therethrough. As shown in Figures 17 and 18, the bobbin 383 includes a main body 3832 in the shape of an "I", the main body 3832 is provided with a winding groove 3834, and the part of the main body 3832 surrounded by the winding groove 3834 is provided with a second threading hole , the proximal end of the main body 3832 is protruded with a protruding rafter 3836 , and the protruding rafter 3836 is provided with an internally threaded hole extending in the axial direction, and the internally threaded hole is adapted to the external thread at the distal end of the threaded rod 82 .

As shown in Figure 16, when the bobbin 383 is accommodated in the accommodating cavity of the housing 381, a pair of first threading holes of the casing 3812 are aligned with the second threading holes of the bobbin 383 for the delivery wire 54 and tightening. The wire 32 passes through, and the inner wall of the casing 3812 and the wire winding groove 3834 of the main body 3832 form a receiving space for receiving the tightening wire 32 wound by the winding shaft 383 . The yoke 3836 at the proximal end of the winding shaft 383 passes through the through hole at the proximal end of the casing 3812 to be threadedly connected with the threaded rod 82 and clamped with the rotating shaft 84 . Wherein, it should be noted that the distal end of the outer sheath tube 86 of the adjustment device 80 is provided with engaging teeth corresponding to the engaging teeth 3816 at the proximal end of the housing 3812, and the engaging teeth at the distal end of the outer sheath tube 86 are engaged with the proximal end of the housing 3812. The teeth 3816 mesh with each other to fix the housing 381. By rotating the rotating shaft 84 engaged with the winding shaft 383, the winding shaft 383 can be driven to rotate relative to the housing 381, and the tightening wire 32 passing through the wire take-up device 38 can be wound. , so as to achieve ring shrinkage.

Further, as shown in FIGS. 16 to 19 , a stop mechanism is provided between the distal end of the bobbin 383 and the bottom case 3814 of the casing 381 , which allows the bobbin 383 to rotate forward relative to the casing 381 to Wind up the tightening wire 32 passed through the wire take-up 38 , and restrict the reverse rotation of the winding shaft 383 relative to the housing 381 . When the rotation of the winding shaft 383 stops, the tightening wire 32 can be locked.

As shown in Figures 17 to 19, the proximal end of the bottom shell 3814 is provided with a first stopper 3818, and the distal end of the bobbin 383 is provided with a second stopper 3838 corresponding to the first stopper 3818, and the first stopper 3838 3818 cooperates with the second stopper 3838 to realize the unidirectional rotation of the bobbin 383 relative to the housing 381 . Specifically, the first stopper part 3818 and the second stopper part 3838 are several helical tooth structures distributed along the circumferential direction of the proximal end surface of the bottom shell 3814 and the circumferential direction of the distal end surface of the winding shaft 383 respectively. Cooperate so that the bobbin 383 can only rotate in one direction.

Since the helical tooth structure is used to stop, when the winding shaft 383 rotates relative to the casing 381 , the winding shaft 383 floats along the axial direction of the casing 381 inside the casing 381 . An elastic member 385 is also provided between the proximal end of the bobbin 383 and the shell of the housing 381 to ensure the smooth movement of the bobbin 383 relative to the housing 381 . Wherein, the elastic member 385 may be a spring, a tubular shrapnel, an elastic bellows, etc., preferably a spring.

In other embodiments, the first stopper 3818 and the second stopper 3838 may also be other structural combinations capable of one-way rotation, such as elastic pieces and slots, which are not limited.

It can be understood that, in other embodiments, the delivery device 50 can also omit the delivery wire 54, and the length of the tightening wire 32 is long enough to extend outside the body of the patient. After shrinking the thread 32 to achieve the best effect of reducing blood reflux, the tightening thread 32 can be locked and cut by a locker in the prior art, such as thread knot locking or locking nail locking, which will not be repeated here.

It should be noted that the anchoring device 10, the delivery device 50, the guiding device 70, and the adjusting device 80 included in the transcatheter ring shrinkage system 1 also have corresponding control handles, and their structures are basically similar to those in the prior art. , which will not be repeated here.

The process of using the transcatheter ring shrinking system 1 in the first embodiment for mitral annuloplasty will be described below with reference to FIG. 2 , FIG. 3 , and FIG. 20 to FIG. 22 . Among them, the surgical route is: transfemoral vein - inferior vena cava - right atrium (RA) - atrial septum (AS) - left atrium (LA) - mitral valve (MV) annulus.

The first step is to puncture through the femoral vein, and establish the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-two through the guide wire and atrial septal puncture device (the guide wire and atrial septal puncture device are not shown in the figure). Orbit of the cusp annulus.

In the second step, as shown in FIG. 20 , the guiding device 70 is advanced along the guide wire until its distal end passes through the foramen ovale to reach the left atrium and near the annulus, and the guide wire is withdrawn.

In the third step, as shown in FIG. 21 , the threading ring 347 of the first anchor assembly 34 is connected to the distal end of the tightening wire 32, and the proximal end of the tightening wire 32 is detachably connected to the distal end of the delivery wire 54, and the After the first anchoring assembly 34 is assembled with the anchoring device 10, together with the tightening wire 32 and the delivery wire 54, it is put through the delivery sheath 52, and the delivery sheath 52 is axially distal in the guide device 70. Move to its distal end against the annulus. As shown in FIG. 22 , the first anchor assembly 34 is then implanted on the annulus of the mitral valve using the anchor device 10 passed through the delivery sheath 52 .

In the fourth step, after the first anchoring component 34 is implanted, the anchoring device 10 and the delivery sheath 52 are withdrawn, and then the spacer 36 is introduced into the guide device 70 through the delivery line 54 and the pusher 90, and the assembled The anchoring device 10 of the second anchoring assembly 34 is worn in the delivery sheath 52 and pushed into the left atrium along the guide device 70, and at the same time, the advancement of the spacer 36 is pushed forward by the delivery sheath 52, Reaching the vicinity of the annulus, the spacer 36 is advanced from the introducer 70 between the first anchor assembly 34 and the second anchor assembly 34 . Under ultrasound and digital subtraction angiography (DSA), according to the size of the diseased valve annulus, control the guide device 70 and the anchor device 10 to adjust the position of the second anchor component 34, and implant the second anchor component 34. The distance between the second anchor component 34 and the first anchor component 34 needs to be greater than the axial length of the spacer 36 .

The fifth step, repeating the fourth step, sequentially implant the anchoring assembly 34 and the spacer 36 from the anterior triangle of the mitral valve along the posterior annulus to the posterior triangle or reversely, so that the anchoring assembly 34 and the spacer The components 36 are evenly distributed on the valve annulus (as shown in FIG. 2 ). After a sufficient number of anchoring components 34 are implanted, the anchoring device 10 and the delivery sheath 52 are withdrawn.

In the sixth step, first connect the wire retractor 38 to the distal end of the adjustment device 80, then pass the proximal end of the delivery wire 54 through the wire retractor 38, and send the wire retractor 38 to the mitral valve through the guide device 70 Then rotate the rotating shaft 84 of the adjustment device 80 forward, so that the winding shaft 383 of the wire take-up device 38 can adjust the length of the tightening wire 32, thereby driving the annulus to shrink. After a good ring shrinking effect is achieved, lock and tighten Thread 32, and then reverse the threaded rod 82, so that the wire retractor 38 is separated from the adjustment device 80 so as to withdraw the adjustment device 80, so that the implant 30 is left on the annulus (as shown in Figure 3), and the ring reduction operation is completed .

It should be noted that during the implantation of the anchoring assembly 34, there is a low probability of thread pressure. At this time, the driving tube 12 of the anchoring device 10 can be reversely rotated in combination with DSA and ultrasonic equipment, and the anchor can be loosened. Fix the anchor assembly 34 so that the tightening wire 32 is disengaged, and then re-tighten the anchor assembly 34 to perform implantation.

It can be understood that the transcatheter ring shrinkage system 1 provided in the present application can also be applied to the annuloplasty of the tricuspid valve, which will not be repeated here. In addition, it should be noted that the transcatheter ring retraction system 1 provided in the present application can also be used to implant a plurality of anchor assemblies 34 connected in series through tightening wires 32 in heart tissues such as left ventricle wall or right ventricle wall. Tighten the tightening wire 32 to reduce the distance between multiple anchor components 34, so as to reduce the volume of the ventricle by narrowing the ventricle to achieve the purpose of reducing the valve annulus, thereby achieving the treatment of mitral regurgitation or tricuspid regurgitation . In addition to being directly implanted on the annulus of the atrium in the illustrated embodiment, the implant 30 can also be implanted under the annulus, that is, the implant 30 can also be implanted in the left ventricle under the mitral valve annulus. wall or right ventricular wall below the tricuspid annulus. Wherein, implanting the implant 30 on the wall of the left ventricle is especially suitable for treating heart failure and functional mitral valve regurgitation caused by abnormal left ventricle function. For example, the guide device 70 can be punctured from the femoral artery, retrogradely enters the left ventricle through the aortic valve, and implants the implant 30 on the wall of the left ventricle through the delivery device 50 and the anchoring device 10. After the tightening wire 32 is tightened Direct inhibition of left ventricular expansion to achieve the purpose of narrowing the mitral valve annulus, the annulus can preserve the natural structure of the mitral valve. That is to say, the transcatheter ring shrinkage system 1 of the present application is not only used for shrinking the valve ring during annuloplasty, but also can be used for reducing the volume of the ventricle during ventricular volume reduction. The use process of valve annuloplasty is basically similar and will not be repeated here.

The implant 30 is implanted on the wall of the left ventricle or the wall of the right ventricle. When the tightening wire 32 is tightened, the threading rings 347 of the plurality of anchoring components 34 can also move under the tension force of the tightening wire 32 To the state after the tightening line 32 is tightened, the threading direction of the threading ring 347 is along the circumferential direction of the ventricle wall, which greatly reduces the resistance of the tightening line 32 during contraction, and there is no bending of the tightening line 32 The situation and the contraction is stable and smooth, ensuring the stability of the narrowed ventricle, and the effect is good. At the same time, since the resistance of the tightening wire 32 in the tightening direction is greatly reduced, the tightening force is reduced and the force distributed on each anchor component 34 is more uniform, so that each anchor component 34 The tightening force received is greatly reduced, which reduces the force of each anchoring component 34 on the ventricular wall, reduces the risk of damage to the ventricular wall, and avoids the occurrence of a large proportion of the tightening force of a single anchoring component 34 Therefore, the risk of the anchor component 34 falling off is reduced, and the implantation is safer.

To sum up, the transcatheter ring retraction system 1 of the present application can be used to anchor multiple rings connected in series through the tightening wire 32 on cardiac tissues such as the mitral valve ring, tricuspid valve ring, left ventricle wall, and right ventricle wall. The anchor component 34 narrows the distance between multiple anchor components 34 by tightening the wire 32, so as to realize the treatment of heart failure caused by mitral valve regurgitation, tricuspid valve regurgitation or left ventricular dysfunction.

Please refer to FIG. 23 to FIG. 25 together. The structure of the transcatheter ring shrinkage system provided by the second embodiment of the present application is similar to the structure of the transcatheter ring shrinkage system 1 of the first embodiment. The difference is that in the second embodiment In the example, the structure of the connecting piece 345b of the anchor assembly 34b is different, and the connecting piece 345b has two degrees of freedom, including the rotational degree of freedom that the connecting piece 345b rotates around the central axis Z of the anchoring piece 340 and the rotation degree along the central axis Z of the anchoring piece 340. The translational freedom of Z movement; the threading ring 347 has two degrees of freedom, including the rotational degree of freedom of rotation around its own central axis X and the left and right deflection around the third radial axis Y parallel to the central axis Z of the anchor 340 rotational degrees of freedom. The connector 345b includes an assembly portion 3451 and a connection portion 3453 connected to the assembly portion 3451 , and the threading ring 347 is movably connected to the connection portion 3453 . The assembly part 3451 is movably sleeved on the anchor seat 343 , specifically, the assembly part 3451 is movably sleeved on the support part 3433 of the anchor seat 343 .

Specifically, as shown in FIG. 23 to FIG. 25 , the assembling portion 3451 is provided with an assembling hole 3452 , and the connecting portion 3453 is provided with a connecting hole 3454 . The assembling part 3451 is movably sleeved on the supporting part 3433 of the anchor base 343 through the assembling hole 3452 , and the threading ring 347 is movably connected with the connecting hole 3454 of the connecting part 3453 . Wherein, the axial width of the connecting groove 3435 of the anchor seat 343 is greater than the axial thickness of the fitting part 3451, preferably 2-3 times the axial thickness of the fitting part 3451, so that the connecting part 345b can move along the axial direction of the anchoring part 340. Move, that is, have a translational degree of freedom to move along the central axis Z of the anchoring piece 340, and at the same time, the connecting piece 345b can also rotate 360 degrees around the central axis Z of the anchoring piece 340, that is, have a central axis Z around the anchoring piece 340 Rotational degrees of freedom for rotation. In this embodiment, the left-right deflection angle of the threading ring 347 around the third radial axis Y can reach 90 degrees (90 degrees to the left and 90 degrees to the right).

It can be understood that, in the second embodiment, the connecting member 345b can rotate around the central axis Z of the anchoring member 340, and the threading ring 347 can move to match the tightening wire under the action of the tensioning force when the tightening wire 32 is tightened. In the state after 32 is tightened, the threading direction of the threading ring 347 can be along the circumferential direction of the annulus, so that the resistance of the contraction process of the tightening line 32 is greatly reduced, and the tightening line 32 does not have a bending situation and the contraction is stable and smooth. The connecting piece 345b can move along the axial direction of the anchoring piece 340. When the anchoring depths of the anchoring parts 341 of multiple anchoring components 34 are inconsistent, the tightening wire 32 can be pulled to move the connecting piece 345b up and down in the axial direction. Furthermore, the bending of the tightening wire 32 is reduced, and the tightening wire 32 is distributed on the same plane as far as possible and shrinks stably and smoothly. While the threading ring 347 itself is movable, it is better to cooperate with the connecting piece 345b to adjust the direction to reduce the contraction resistance of the tightening wire 32 . Therefore, the anchor component 34b can also ensure the stability of the shrink ring, and the ring shrink effect is good.

The application of the transcatheter ring shrinkage system in the second embodiment is consistent with the application of the transcatheter ring shrinkage system 1 in the first embodiment, and can also be used in the mitral valve ring, tricuspid valve ring, left ventricular wall, A plurality of anchoring components 34b connected in series through the tightening wire 32 are anchored into cardiac tissues such as the right ventricle wall, and the distance between the multiple anchoring components 34b is reduced by tightening the wire 32, thereby realizing mitral valve regurgitation, Treatment of heart failure due to tricuspid regurgitation or abnormal left ventricular function.

Please refer to Fig. 26 and Fig. 27 together. The structure of the transcatheter ring shrinkage system provided by the third embodiment of the present application is similar to the structure of the transcatheter ring shrinkage system 1 of the first embodiment, the difference is that in the third embodiment In one example, the anchoring assembly 34c also includes a flexible sheath 349, which wraps the anchoring portion 341 of the anchoring assembly 34c, and the flexible sheathing 349 can be used to prevent tightening of the wire 32, the delivery wire 54 and the anchoring portion 341. Winding occurs.

Wherein, the axial length of the flexible sheath 349 is greater than or equal to the axial length of the anchoring portion 341 . It can be understood that since the anchoring portion 341 of the anchoring assembly 34c is wrapped by the flexible sheath 349, the delivery sheath 52 will not be scratched during the delivery of the anchoring assembly 34c, and the implantation of the anchoring assembly 34c It also protects the annulus during the process, reducing the risk of damage to the annulus. As shown in FIG. 27 , after the anchoring component 34c is implanted in the valve annulus, the flexible sheath 349 is compressed between the anchoring seat and the valve annulus, which acts as a buffer and reduces the risk of the anchoring component 34c falling off. At the same time, the risk of mutual interference between the anchor components 34c is reduced during implantation. The flexible sheath 349 can be made of polyester material with good biocompatibility, such as PET.

It can be understood that the outside of the anchoring portion 341 of the anchoring assembly 34b in the second embodiment can also wrap the flexible sheath 349 . The application of the transcatheter ring shrinkage system in the third embodiment is consistent with the application of the transcatheter ring shrinkage system 1 in the first embodiment, and can also be used in the mitral valve ring, tricuspid valve ring, left ventricular wall, A plurality of anchoring components 34c connected in series through the tightening wire 32 are anchored into the heart tissue such as the right ventricle wall, and the distance between the multiple anchoring components 34c is reduced by tightening the wire 32, thereby realizing mitral valve regurgitation, Treatment of heart failure due to tricuspid regurgitation or abnormal left ventricular function.

The above is the implementation of the embodiment of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the embodiment of the present application, some improvements and modifications can also be made. These improvements and modifications are also It is regarded as the scope of protection of this application.

Claims (26)

1. An anchor assembly with a threading ring, characterized in that it comprises:

   An anchor for anchoring into human tissue;

   A connector, the connector is movably sleeved on the anchor, the connector has at least two degrees of freedom, one of the degrees of freedom of the connector is the connector around the anchor Rotational degrees of freedom for rotation of the central axis of the part; and

   The threading ring is movably connected with the connecting piece.
2. The anchor assembly with a threading ring according to claim 1, wherein the degree of freedom of the connecting member further includes a degree of freedom of translational movement along the axial direction of the anchor member.
3. The anchoring assembly with a threading ring according to claim 2, wherein the anchoring member comprises an anchoring part and an anchoring seat connected to the proximal end of the anchoring part, and the anchoring part is used for Anchored into the human tissue, the outer wall of the anchor seat is provided with a connecting groove along the circumference; the connecting piece is movably sleeved on the anchor seat and partially accommodated in the connecting groove.
4. The anchoring assembly with a threading ring according to claim 3, wherein the connecting member comprises a fitting part and a connecting part connected with the fitting part, and the threading ring is movably connected with the connecting part.
5. The anchor assembly with threading ring according to claim 4, wherein the assembly part is movably sleeved on the anchor seat.
6. The anchor assembly with a threading ring as claimed in claim 3, wherein said connector includes a first radial axis and a second radial axis perpendicular to each other, and the degree of freedom of said connector further includes A rotational degree of freedom for rotation along the first radial axis and a translational degree of freedom for movement along the second radial axis.
7. The anchor assembly with a threading ring according to claim 6, wherein the connecting member is a connecting ring, and the threading ring is directly interlocked with the connecting ring.
8. The anchor assembly with a threading ring according to claim 7, wherein the inner diameter of the connecting ring is larger than the maximum outer diameter of the anchor seat, and smaller than the maximum outer diameter of the anchor seat and the maximum outer diameter of the anchor seat. The sum of the minimum radial thicknesses of threaded rings.
9. The anchor assembly with a threading ring according to claim 7, wherein the radial depth of the connecting groove is greater than the radial thickness of the connecting ring and less than twice the radial thickness of the connecting ring.
10. The anchor assembly with threading ring according to claim 7, characterized in that, along the axial direction of the anchor seat, there is a gap between the connecting groove and the connecting ring, and the gap is connected to the connecting ring. The ratio of the axial thickness of the ring is in the range of 1/20-1/8.
11. The anchor assembly with a threading ring according to claim 7, wherein the ratio of the radial depth of the connecting groove to the maximum outer diameter of the anchor seat is in the range of 1/8-1/4.
12. The anchor assembly with a threading ring according to any one of claims 7-11, wherein the connecting ring is a circular ring or an elliptical ring, and the axial cross-sectional shape of the connecting ring is circular or elliptical ;and / or

    The threading ring is a circular ring or an elliptical ring, and the axial cross-sectional shape of the threading ring is circular or elliptical.
13. 2. The anchor assembly with threading loop of claim 1, wherein said threading loop has at least two degrees of freedom.
14. The anchor assembly having a threading ring as recited in claim 13, wherein the threading ring includes a third radial axis parallel to the central axis of the anchor, the degrees of freedom of the threading ring include A rotational degree of freedom for the rotation of the central axis and a rotational degree of freedom for rotation about the third radial axis.
15. The anchor assembly with a threading loop as claimed in claim 3, further comprising a flexible sheath enclosing the anchor portion.
16. The anchor assembly with a threading ring according to claim 1, wherein the connecting member and/or the threading ring are flexible.
17. An implant for contracting heart tissue, characterized in that the implant comprises tightening wires and a plurality of anchoring components with threading loops according to any one of claims 1-16, and the plurality of The anchoring components are connected by the tightening wire and respectively anchored into the heart tissue;

    The distal end of the tightening wire is connected to the threading loop of the first anchor assembly for anchoring into the heart tissue, and the proximal end is slidable through the other anchors for anchoring into the heart tissue. Threading loop for components.
18. The implant according to claim 17, wherein said implant further comprises at least one spacer, said spacer is threaded on said tightening wire, and at least one of said spacers is located between two between the anchor components.
19. The implant according to claim 17 or 18, wherein the implant further comprises a wire take-up, the wire take-up includes a casing and a winding shaft rotatably arranged in the casing, The proximal end of the tightening wire moves through the housing and the winding shaft, and the winding shaft rotates relative to the housing to wind the tightening wire. When the winding shaft stops rotating, The tightening wire is locked in the radial space between the winding shaft and the casing.
20. A transcatheter ring retraction system, characterized in that it includes an anchoring device and the implant according to claim 17, the anchoring device includes a driving tube and a connecting rod worn in the driving tube, the The proximal end of the anchor member is provided with a first connecting portion, the distal end of the driving tube is provided with a second connecting portion detachably connected with the first connecting portion, and the connecting rod is axially passed through the mating connection The first connecting portion and the second connecting portion of the anchoring assembly are kept connected with the anchoring device, and the driving tube is used to drive the anchoring member to be anchored into the valve annulus.
21. The transcatheter ring shrinkage system according to claim 20, wherein the transcatheter ring shrinkage system further comprises a delivery device, the delivery device is used to deliver the implant to the heart tissue, so The delivery device includes a delivery sheath, the anchor assembly is connected to the anchor device, and the tightening wire passes through the threading loop of the anchor assembly and is entirely worn in the delivery sheath.
22. The transcatheter ring shrinkage system according to claim 21, characterized in that, the transcatheter ring shrinkage system further comprises a guiding device and a pusher, the guiding device comprises at least one guiding sheath, and the implanted The object also includes at least one spacer;

    The distal end of the pushing member is provided with a threading hole for the proximal end of the tightening wire to move through, and the pushing member pushes the spacer along the tightening wire into the guiding sheath, The delivery sheath is threaded within the introducer sheath to advance the septum within the introducer sheath.
23. The transcatheter ring shrinkage system of claim 21, wherein the delivery device further comprises a delivery wire connected to a proximal end of the tightening wire.
24. The transcatheter ring retraction system according to claim 23, wherein the implant further comprises a wire take-up, the wire take-up includes a housing and a winding shaft rotatably disposed in the housing, The wire retractor moves to the far end of the delivery wire so that the proximal end of the tightening wire can move through the housing and the winding shaft, and the winding shaft rotates relative to the housing to The tightening wire is wound, and when the winding shaft stops rotating, the tightening wire is locked in the radial space between the winding shaft and the housing.
25. The transcatheter ring shrinkage system according to any one of claims 20-24, wherein the heart tissue includes a mitral valve ring, a tricuspid valve ring, a left ventricular wall, and a right ventricular wall.
26. The application of the transcatheter ring shrinkage system according to any one of claims 20-24, characterized in that the transcatheter ring shrinkage system is used to shrink the valve ring in annuloplasty, or to reduce the volume of the heart in ventricular volume reduction. Be careful with chamber volume.