CN115737203A

CN115737203A - Anti-coiling anchor assembly, implant and transcatheter heart repair system

Info

Publication number: CN115737203A
Application number: CN202111368908.4A
Authority: CN
Inventors: 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: 2021-11-18
Publication date: 2023-03-07
Also published as: WO2023029726A1

Abstract

The present application provides wire-wrap resistant anchor assemblies, implants, and transcatheter cardiac repair systems. The anchor assembly includes an anchor and a flexible sheath. The anchor comprises an anchoring portion for anchoring into human tissue. Flexible sheath wraps up in the outside of anchor portion. Wherein the anchor assembly is coupled to receive a tensioning line. The application provides an anchoring assembly, at the flexible sheath of outside parcel in the anchoring portion of anchoring piece, not only can avoid the anchoring piece in transportation process scratch transport sheath pipe, can avoid the anchoring piece to take place the winding with the stringing of being connected anchoring assembly at the implantation in-process moreover, guarantees anchoring assembly's implantation smoothly to be favorable to reducing the operation risk.

Description

Anti-coiling anchor assembly, implant and transcatheter heart repair system

Technical Field

The application relates to the technical field of medical equipment, in particular to an anti-winding anchoring assembly, an implant and a transcatheter heart repair system.

Background

Mitral Regurgitation (MR) is a common disease of heart valves, including primary and secondary mitral regurgitation. Primary mitral regurgitation is caused by mitral valve leaflet abnormality, chordae tendineae rupture, or papillary muscle insufficiency, and secondary mitral valve regurgitation is caused by annular dilatation, left atrial and left ventricular enlargement, which results in mitral valve anterior-posterior leaflet malocclusion. Mitral valve intervention has progressed rapidly in recent years, mainly involving valve repair or valve replacement. Among these, mitral annuloplasty is a common repair procedure that reduces mitral regurgitation by reducing the size of the patient's annulus.

In the prior art, mitral regurgitation is reduced by sequentially implanting a plurality of anchors slidably attached to a tether through a transcatheter pathway at the annulus of the mitral valve, and then tightening the tether to shorten the distance between the anchors at the annulus to circumferentially constrict the annulus. The distal end of the anchor is typically helical or has a sharp tip so that the anchor is implanted in the annulus tissue. However, in the process of anchor delivery and implantation, because the anchor is threaded on the rope, the anchor and the rope are both delivered in the same delivery sheath, the anchor easily scratches the inner wall of the delivery sheath and is easily wound with the rope, and the surgical risk is increased.

Disclosure of Invention

In one aspect, the present application provides an anchor assembly for a wire harness including an anchor and a flexible sheath. The anchor comprises an anchoring portion for anchoring into human tissue. The flexible sheath wraps the outside of the anchoring portion. Wherein the anchor assembly is coupled to receive a tension line.

In another aspect, the present application also provides an implant comprising a cinch cord and a plurality of anti-wind anchor assemblies as described above. A plurality of the anchor assemblies are connected by the cinch wire and are each configured to anchor into cardiac tissue. One end of the tightening wire is fixedly connected to a first of the anchor assemblies anchored in the heart tissue, and the other end is slidably passed through the other anchor assembly anchored in the heart tissue.

In yet another aspect, the present application also provides a transcatheter cardiac repair system comprising an anchoring device and an implant as described above. The anchoring device comprises a driving tube and a connecting rod which is arranged in the driving tube in a penetrating mode, a first connecting portion is arranged at the near end of the anchoring piece, a second connecting portion which is detachably connected with the first connecting portion is arranged at the far end of the driving tube, the connecting rod axially penetrates through the first connecting portion and the second connecting portion which are connected in a matching mode so that the anchoring assembly is connected with the anchoring device, and the driving tube is used for driving the anchoring piece to be anchored into the heart tissue.

The application provides a prevent wire-wound anchor subassembly, implant and through pipe heart repair system, at the outside parcel flexible sheath of the anchor portion of anchor, not only can avoid the anchor to scrape in transportation process and carry the sheath pipe, can avoid the anchor to take place the winding with the tightening wire of being connected anchor subassembly in implantation process moreover, guarantee anchor subassembly's smooth implantation to be favorable to reducing the operation risk.

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 are briefly introduced 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 without creative efforts.

Fig. 1 is a schematic structural diagram of a transcatheter cardiac repair system provided in accordance with an embodiment of the present application.

Fig. 2 is a schematic view of an implant implanted in an annulus and with a cinch wire not cinched according to an embodiment of the present application.

FIG. 3 is a schematic view of the FIG. 2 wire take-up after it has been tightened.

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

Fig. 5 is a side view of the anchor assembly of fig. 4.

Fig. 6 is a perspective view of an anchor assembly provided in accordance with another embodiment of the present application.

Fig. 7 is a perspective view of an anchor assembly provided in accordance with yet another embodiment of the present application.

Fig. 8 is a schematic view of the anchor of fig. 4 separated from the flexible sheath.

Fig. 9 is a perspective view of the anchor mount of fig. 8.

Fig. 10 is a schematic view of the connection of fig. 4 rotated upward about a first radial axis.

Fig. 11 is a schematic view of the coupling of fig. 4 rotated downwardly about a first radial axis.

Fig. 12 is a schematic view of the threading of fig. 4 rotated to the right about the third radial axis.

Fig. 13 is a schematic view of the threading of fig. 4 rotated upward about a fourth radial axis.

Fig. 14 is an axial cross-sectional view of the anchor assembly of fig. 6.

Fig. 15 is a perspective view of the connector of fig. 14.

Fig. 16 is a schematic view of the anchor assembly of fig. 7 after being anchored to the annulus.

Fig. 17 is a schematic view of the anchor assembly of fig. 1 connected to an anchoring device.

Fig. 18 is a schematic illustration of the anchor assembly of fig. 17 separated from the anchoring device.

Fig. 19 is an axial cross-sectional view of the anchor assembly of fig. 17 in connection with an anchoring device.

Fig. 20 is a schematic view of the connection of the anchor assembly to the cinch cord of the first implanted valve annulus of the implant of fig. 2.

Fig. 21 is a schematic view of the pusher pushing the spacer.

FIG. 22 is a perspective view of the delivery device, anchoring device, anchor assembly, cinch line and spacer threaded into the guide device.

Figure 23 is an axial cross-sectional view of the wire take-up device attached to the distal end of the adjustment device.

Fig. 24 is a schematic view of the bobbin and the bottom case of the wire winder in fig. 23.

Fig. 25 is a perspective view of the bobbin of fig. 24.

Fig. 26 is a schematic perspective view of the bottom case in fig. 24.

Fig. 27-30 are schematic illustrations of a procedure for using a transcatheter cardiac repair system according to an embodiment of the present application.

The following specific examples will further illustrate the application in conjunction with the above figures.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

The technical solutions in the embodiments of the present application will be described clearly and completely with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without inventive step, are within the scope of the present disclosure.

In addition, the following description of the various embodiments refers to the accompanying drawings, which are included to illustrate specific embodiments that the application may make. Directional phrases used in this application, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the direction of the appended figures and, therefore, are used in order to better and more clearly illustrate and understand the present application and are not intended to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in the particular orientation, and, therefore, should not be taken to be limiting of the present application.

It is noted that the terms "proximal" and "distal" are used herein as terms commonly used in the interventional medical field to more clearly describe the structure of the wire-resistant anchor assembly, implant and transcatheter cardiac repair system provided herein. 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; the direction of a rotating central shaft of an object such as a column body, a pipe body and the like is defined as an axial direction; the circumferential direction is the direction around the axis of objects such as a column body, a pipe body and the like; radial is the direction along a diameter or radius.

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", "terminal end", "two 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. 1-3 together, the present application provides a transcatheter heart repair system 1 for implanting a plurality of anchor assemblies 34 connected in series by a cinch cord 32 in heart tissue, such as a mitral valve annulus, a tricuspid valve annulus, a left ventricular wall, or a right ventricular wall, wherein the cinch cord 32 is tightened to reduce the spacing between the anchor assemblies 34, thereby reducing the annulus or narrowing the ventricle to reduce blood regurgitation. Specifically, the transcatheter cardiac repair system 1 includes an anchoring device 10, an implant 30, a delivery device 50, and a guide device 70.

Referring to fig. 1, in some embodiments, the guiding device 70 includes a first guiding sheath 71 and a second guiding sheath 72 penetrating the first guiding sheath 71, wherein the second guiding sheath 72 can extend from the distal end of the first guiding sheath 71 and be attached to the cardiac tissue such as the valve annulus or the ventricular wall, so as to establish an access channel from the outside of the body to the heart.

Preferably, the first guiding sheath 71 and the second guiding sheath 72 are both adjustable bending sheaths, so that the distal end of the guiding device 70 can be adjusted to fit the angle of the valve annulus or the ventricular wall, and the two adjustable bending sheaths can better adjust the bending angle and direction of the distal end of the guiding device 70. Of course, in other embodiments, the guide device 70 may employ only one bendable guide sheath. The bendable guiding sheath is a guiding device commonly used in interventional surgery in the prior art, and is not described herein.

Referring to fig. 2 and 3, in some embodiments, implant 30 includes a cinch cord 32 and a plurality of anchor assemblies 34, each of the plurality of anchor assemblies 34 connected by cinch cord 32 for anchoring to heart tissue. The heart tissue shown in fig. 2 and 3 is an annulus. Each anchor assembly 34 is removably attachable to the distal end of the anchor assembly 10, and the anchor assembly 10 is used to implant the anchor assembly 34 into cardiac tissue. The delivery device 50 is used for delivering the implant 30 to the cardiac tissue, and the delivery device 50 includes a delivery sheath 52, the anchoring device 10 is threaded into a lumen of the delivery sheath 52, and the delivery sheath 52 is used for delivering the anchor assembly 34 connected to the distal end of the anchoring device 10 to the cardiac tissue. The distal end of the delivery sheath 52 is flexible, and the delivery sheath 52 is inserted into the lumen of the second guiding sheath 72, and the distal end of the delivery sheath 52 can be driven to bend by adjusting the bending angle of the distal end of the guiding device 70. One end of the puller wire 32 is fixedly attached to a first anchor assembly 34 anchored to the heart tissue and the other end of the puller wire 32 is slidably threaded through the other anchor assembly 34 anchored to the heart tissue.

When using the transcatheter heart repair system 1 to perform a ventricular systole or narrowing, an access channel is first established from outside the patient's body to the heart through the guiding device 70, the delivery sheath 52 with the anchoring device 10, the anchoring assembly 34, and the tightening wire 32 threaded therethrough is then moved axially distally within the lumen of the second guiding sheath 72 to abut the annulus or ventricular wall, and the anchoring device 10 drives the anchoring assembly 34 within the delivery sheath 52 to anchor the annulus or ventricular wall. The plurality of anchor assemblies 34 are sequentially anchored at different circumferential positions of the annulus or ventricular wall through the same steps as described above (as shown in fig. 2), and the plurality of anchor assemblies 34 are relatively gathered by tightening the tightening wire 32 (as shown in fig. 3), so as to contract the annulus or ventricular wall, thereby achieving the purpose of contracting the annulus or the ventricle.

Referring to fig. 4-7, the anti-wind anchor assembly 34 of the present application includes an anchor 341 and a flexible sheath 343. Anchor 341 includes an anchor portion 3412 for anchoring into human tissue. Flexible sheath 343 wraps around the exterior of anchor 3412. Wherein the anchor assembly 34 connects the tensioning wire 32.

It can be understood that, in the anchor assembly 34 provided by the present application, since the flexible sheath 343 is wrapped outside the anchoring portion 3412 of the anchor 341, the anchor 341 can be prevented from scratching the delivery sheath 52 during the delivery process, and the anchor 341 can be prevented from being wound around the tightening wire 32 during the implantation process, so as to ensure the smooth implantation of the anchor assembly 34, thereby being beneficial to reducing the surgical risk.

Furthermore, anchor portion 3412 of anchor 341 is wrapped with flexible sheath 343 to reduce the risk of interference between adjacent anchor assemblies 34 implanted in body tissue. In addition, the flexible sheath 343 can also protect the body tissue during implantation of the anchor assembly 34 into the body tissue, reducing the risk of damage to the body tissue. When the anchor assembly 34 and the tightening wire 32 are applied to shrink the annulus or constrict the ventricle, the body tissue is heart tissue, including the mitral valve annulus, the tricuspid valve annulus, the left ventricle wall, or the right ventricle wall, etc. The anchor assembly 34 described herein is primarily intended for use in a transcatheter cardiac repair system 1, and will therefore be described hereinafter in terms of human tissue as cardiac tissue.

In some embodiments, the axial length of flexible sheath 343 is greater than or equal to the axial length of anchor portions 3412, such that anchor portions 3412 may be completely encased within flexible sheath 343. As shown in fig. 4-7, the anchor portion 3412 of the anchor assembly 34 is a helical anchor having a pointed end for ease of implantation into cardiac tissue for stability of implantation. Although anchor 3412 is exemplified herein as a helical anchor, in other embodiments, anchor 3412 can be of another suitable configuration that enables anchor 3412 to engage and substantially secure to cardiac tissue, such as, but not limited to, barbs, hooks, tines, and the like.

Further, the flexible sheath 343 has a lumen, the flexible sheath 343 may be cylindrical, the lumen of the flexible sheath 343 has a radial dimension larger than an outer diameter of the anchor portion 3412, and the anchor 341 rotates relative to the flexible sheath 343 during anchoring of the anchor portion 3412 into the cardiac tissue. Thus, during implantation of the anchor assembly 34, rotation of the anchor 341 does not cause the flexible sheath 343 to follow rotation, resulting in a substantial reduction in resistance of the anchor assembly 34 during implantation into cardiac tissue.

Referring to fig. 8, in some embodiments, a through hole 3432 is formed at the proximal end of the flexible sheath 343, and the anchor portion 3412 of the anchor 341 is inserted into the inner cavity of the flexible sheath 343 through the through hole 3432, so that the flexible sheath 343 covers the anchor portion 3412. Anchor 3412 is a helical anchor that may be threaded through opening 3432 into the lumen of the flexible sheath. Optionally, the distal end of the flexible sheath 343 is open or closed. It will be appreciated that the distal end of the flexible sheath 343 is open and the anchor 3412 located within the flexible sheath 343 provides no additional resistance to anchoring into the heart tissue and is easily anchored into the heart tissue. The distal end of the flexible sheath 343 is closed, and due to the restriction of the anchor portion 3412, the flexible sheath 343 cannot be folded to expose the distal end of the anchor portion 3412 during delivery of the anchor assembly 34, further reducing damage to the inner wall of the delivery sheath 52; while the tip of the distal end of anchor 3412 may puncture the distal end of flexible sheath 343 without interfering with the implantation of anchor 3412. In the illustrated embodiment, the distal end of flexible sheath 343 is closed and has an axial length greater than the axial length of anchor portion 3412.

Referring to fig. 4-6 and 8, in some embodiments, anchor 341 further includes an anchor seat 3414 connected to a proximal end of anchor portion 3412, and a distal end of anchor seat 3414 is provided with a plug portion 3417. Specifically, anchor seat 3414 includes a support 3413, a first connector 3415 disposed at a proximal end of support 3413, and a plug 3417 disposed at a distal end of support 3413. The first connecting portion 3415 is used for detachable connection of the anchoring device 10. The insertion portion 3417 is fixedly connected to the proximal end of the anchoring portion 3412. In this embodiment, the aperture of the through hole 3432 at the proximal end of the flexible sheath 343 is matched with the outer diameter of the insertion part 3417, and the proximal end of the flexible sheath 343 is connected to the insertion part 3417 in a snap-fit manner, so that the flexible sheath 343 is not prone to falling. In other embodiments, the proximal end of flexible sheath 343 can snap into the proximal end of anchor 3412 without flexible sheath 343 falling off. It should be noted that the engagement of the proximal end of the flexible sheath 343 with the insertion part 3417 or the anchoring part 3412 does not affect the relative rotation of the anchor 341 and the flexible sheath 343.

In some embodiments, to ensure safety after implantation, the flexible sheath 343 is made of a flexible material with good biocompatibility, which can be, but is not limited to, one or a combination of Polyester (PET), polytetrafluoroethylene (PTFE), silicone, and urethane. As shown in fig. 2 and 3, due to the flexibility of flexible sheath 343, when anchor 3412 is anchored in the heart tissue, flexible sheath 343 is compressed between anchor 3414 and the heart tissue by compressive deformation, and flexible sheath 343 can provide a cushioning effect and reduce the risk of anchor assembly 34 falling out. Moreover, because of the good biocompatibility of flexible sheath 343, flexible sheath 343 is pressed as a gasket between anchor 3414 and the heart tissue, which is more conducive to cell migration and faster implant endothelialization.

In some embodiments, the anchor assembly further includes a threading structure 345, the threading structure 345 being disposed on the anchor 341 or on the flexible sheath 343, the threading structure 345 being configured to receive the cinch cord 32 therethrough. As shown in FIGS. 2 and 3, each anchor assembly 34 has a threading structure 345 for receiving the tightening wire 32, one end of the tightening wire 32 being fixedly attached to the threading structure 345 of the first anchor assembly 34 anchored in the heart tissue and the other end being slidably threaded through the threading structure 345 of the other anchor assembly 34 anchored in the heart tissue.

Referring to fig. 4-6, in some embodiments, a threading structure 345 is provided on the anchor 341. The threading structure 345 includes a connecting member 3452 and a threading ring 3454 movably connected to the connecting member 3452. The connecting member 3452 is movably sleeved on the anchoring member 341, and the threading ring 3454 is used for connecting the tightening wire 32. Wherein, the connecting member 3452 has at least one degree of freedom, and one of the degrees of freedom of the connecting member 3452 is a rotational degree of freedom in which the connecting member 3452 rotates about the central axis a of the anchor 341.

It can be understood that, since the connecting component 3452 can rotate around the central axis a of the anchoring component 341 and the threading ring 3454 can move relative to the connecting component 3452, after the plurality of anchoring components 34 implanted in the heart tissue are respectively connected with the tightening wires 32 by the threading ring 3454, when the tightening wires 32 are tightened, the threading ring 3454 of the anchoring components 34 can move to the state matched with the tightened tightening wires 32 under the tensioning force of the tightening wires 32, and the threading ring 3454 of each anchoring component 34 can move to enable the threading direction to be along the circumferential direction of the valve ring or the ventricular wall, thereby greatly reducing the resistance of the tightening wires 32 in the tightening process, and the tightening wires 32 are not bent and tightened stably and smoothly, thereby ensuring the stability of the tightening ring or the narrowed ventricular, and the effect of the ring or the ventricular constriction is good. Moreover, because the resistance that receives of tightening line 32 in the direction of tightening reduces greatly, the tightening force reduces and the tightening force distributes the effort on every anchor assembly 34 more evenly for the tightening force that receives of every anchor assembly 34 reduces greatly, has reduced the effort of every anchor assembly 34 to cardiac tissue, has reduced cardiac tissue and has received the risk of damage, avoids appearing the tightening force that single anchor assembly 34 received simultaneously and accounts for the great condition, has reduced the risk that anchor assembly 34 drops, implants safelyr.

Specifically, referring to fig. 9, a connecting groove 3411 is circumferentially formed on an outer wall of the supporting portion 3413, and the connecting member 3452 is movably sleeved on the supporting portion 3413 and is partially received in the connecting groove 3411. The supporting portion 3413 includes the support column and the limiting blocks arranged at the two ends of the support column, the outer diameters of the two limiting blocks are equal and are all larger than the outer diameter of the support column, the support column and the limiting blocks arranged at the two ends of the support column are roughly in an I-shaped structure, and a connecting groove 3411 surrounding the support column is formed. In order to ensure that the anchor 341 can be received in the delivery sheath 52 and have a certain connection strength, the support 3413 is generally tubular, and the outer diameter of the stopper of the support 3413 is larger than the outer diameter of the first connection 3415 and the outer diameter of the plug 3417, i.e. the outer diameter of the stopper of the support 3413 is the largest outer diameter of the anchor 3414.

Referring to fig. 4, in some embodiments, the connecting component 3452 is a connecting ring, and the threading ring 3454 is directly buckled with the connecting ring. Specifically, the connecting ring is movably sleeved on the supporting portion 3413, and the connecting ring portion is received in the connecting groove 3411 and movably connected to the threading ring 3454. It will be appreciated that the threading ring 3454 is directly engaged with the connecting ring such that the central axis of the connecting ring is offset from the central axis a of the anchor 341 and there is a gap in the radial direction between the connecting ring and the supporting post of the support 3413, the connecting ring being capable of rotating 360 degrees about the central axis a of the anchor 341, i.e., the connection 3452 includes a rotational degree of freedom about the central axis a of the anchor 341.

As shown in fig. 4, the inner diameter of connecting element 3452 (i.e., connecting ring) is larger than the largest outer diameter of anchor seat 3414 (i.e., the outer diameter of the stopper of support 3413) and smaller than the sum of the largest outer diameter of anchor seat 3414 and the smallest radial thickness of thimble 3454. Thus, the connection ring does not slip out of the connection groove 3411 and fall off the support 3413. It should be noted that the radial thickness of the threading ring 3454 may be uniform or nonuniform, the uniform thickness may improve the strength and the service life of the threading ring 3454, and the nonuniform thickness may make the threading ring 3454 have a better degree of freedom, which may be selected according to actual needs. When the radial thickness of the entire threading ring 3454 is uniform, the radial thickness of the threading ring 3454, i.e., the minimum radial thickness of the threading ring 3454, is determined by subtracting one half of the difference between the outer diameter of the threading ring 3454 and the inner diameter thereof.

Referring again to fig. 9, the axial width p of the connecting groove 3411 in the axial direction of the anchor block 3414 is greater than the axial thickness of the connecting ring. That is, a gap is formed between the limiting blocks at the two ends of the supporting column and the connecting ring. Thereby, the connection ring is also movable in axial direction of anchor seat 3414, i.e. the degree of freedom of connection 3452 also includes a translational degree of freedom of movement along the central axis a of anchor 341 (i.e. axial direction of anchor 341). Wherein the axial thickness of the coupling ring, i.e. the thickness of the coupling ring in its axial direction.

As shown in fig. 4, the connection 3452 (i.e., connection ring) includes a first radial axis B and a second radial axis C that are perpendicular to each other, both of which are perpendicular to the central axis a of the anchor 341. A gap is formed between the limiting blocks at the two ends of the supporting column and the connecting ring, and the connecting ring can rotate around the first radial axis B, that is, the degree of freedom of the connecting piece 3452 further includes a rotational degree of freedom rotating around the first radial axis B.

Specifically, referring to fig. 10 and 11, the connecting component 3452 can rotate a certain angle in the proximal direction (upward direction shown in fig. 10) around the first radial axis B, and can also rotate a certain angle in the distal direction (downward direction shown in fig. 11) around the first radial axis B. It can be understood that the connecting ring can be limited to rotate within a reasonable angle around the first radial axis B by reasonably designing the size of the axial gap between the limiting blocks at the two ends of the supporting column and the connecting ring. Preferably, the ratio of the gap to the axial thickness of the connection ring is in the range of 1/20 to 1/8, which can limit the connection from deflecting around the first radial axis B by a small angle (for example, by 10 degrees upward and 10 degrees downward with the first radial axis B as a rotation axis), i.e., deflecting in the axial direction of the anchor 341, so as to reduce the resistance applied when the tightening wire 32 is tightened, make the ring shrinkage smoother, and avoid the risk that the connection member 3452 deflects by an excessive angle in the axial direction of the anchor 341 to cause the anchor assembly 34 to fall off.

Referring again to fig. 9, the radial depth q of the connecting groove 3411 is greater than the radial thickness of the connecting ring and less than twice the radial thickness of the connecting ring. Thereby, the connection ring can be fitted to the connection groove 3411 of the support portion 3413 and the connection ring can be moved on the connection groove 3411. Since the radial depth q of the connecting groove 3411 is greater than the radial thickness of the connecting ring, the connecting ring may be moved along the second radial axis C, i.e. the degree of freedom of the connecting part 3452 also includes the translational degree of freedom of movement along the second radial axis C. Similarly, by properly designing the difference between the radial depth q of the connecting groove 3411 and the radial thickness of the connecting ring, the connecting ring may be moved a certain distance along the second radial axis C. In addition, the ratio of the radial depth q of the connecting groove 3411 to the maximum outer diameter of the anchor seat 3414 (i.e., the outer diameter of the stopper of the supporting portion 3413) is in the range of 1/8 to 1/4, so as to prevent the connecting groove 3411 from being grooved too deeply and ensure the strength of the supporting portion 3413.

Thus, as shown in fig. 4, the connection ring, i.e., the connection member 3452 has four degrees of freedom, which are a rotational degree of freedom for rotating about the central axis a of the anchor 341, a translational degree of freedom for moving in the axial direction of the anchor 341, a rotational degree of freedom for rotating about the first radial axis B, and a translational degree of freedom for moving along the second radial axis C.

Of course, in other embodiments, the connecting component 3452 can be another ring-shaped structure with four degrees of freedom, and the connecting component 3452 is indirectly connected to the threading ring 3454. The connecting ring may also be movably sleeved at the proximal end of the anchoring portion 3412, and the anchoring portion 3412 may be designed as a helical anchor or a stopper may be designed on the anchoring portion 3412 so that the connecting ring does not fall off the anchor 341.

Referring again to fig. 4, the threading ring 3454 includes a self-center axis D, a third radial axis E parallel to the center axis a of the anchoring element 341, and a fourth radial axis F perpendicular to the third radial axis E. The string ring 3454, which is movably fastened to the connecting member 3452 (i.e., the connecting ring), also has four degrees of freedom, including a rotational degree of freedom (rotatable by 360 degrees) for rotating about its own central axis D, a rotational degree of freedom for deflecting left and right about the third radial axis E, a rotational degree of freedom for deflecting up and down about the fourth radial axis F, and a translational degree of freedom for moving along its own central axis D.

It can be understood that, as shown in fig. 12 and 13, since the threading ring 3454 is fastened to the connection ring, the threading ring 3454 is less limited by the anchor seat 3414, the movement space is larger, the rotation freedom of the threading ring 3454 about the third radial axis E for left and right deflection is larger, and the left and right relative deflection can reach 200 degrees (the third radial axis E is used as the rotation axis, the left deflection can be 100 degrees, the right deflection can be 100 degrees); the rotation freedom of the threading ring 3454 about the fourth radial axis F is also large, and the relative vertical deflection can reach 120 degrees (60 degrees can be deflected upward and 60 degrees can be deflected downward by using the fourth radial axis F as the rotation axis).

As described above, the connecting members 3452 (i.e., the connecting rings) and the threading rings 3454 of the threading structures 345 of the anchor assemblies 34 have four degrees of freedom, respectively, so that the connecting members 3452 and the threading rings 3454 can be deflected in multiple directions with a wide range of motion after a plurality of anchor assemblies 34 are implanted in the heart tissue. As shown in fig. 3, when the tightening thread 32 is tightened, the connecting component 3452 and the threading ring 3454 will stick to the anchor 3414 under the action of tightening force, the threading ring 3454 will be adjusted to the circumferential direction automatically, so that the tightening thread 32 will form a C-shape in accordance with the valve ring smoothly, the resistance of the tightening thread 32 in the tightening direction is greatly reduced, the tightening thread 32 will not bend and tighten stably and smoothly, the stability of the tightening ring is ensured, and the tightening effect is good. In addition, because the resistance of the tightening line 32 in the tightening direction is greatly reduced, the tightening force is reduced, the acting force of the tightening force distributed on each anchor component 34 is more uniform, the acting force of a corresponding single anchor component 34 is greatly reduced, the acting force of the anchor component 34 on the cardiac tissue is reduced, the risk of the cardiac tissue being damaged is reduced, meanwhile, the condition that the tightening force of the single anchor component 34 accounts for a larger proportion is avoided, the risk of the anchor component 34 falling off is reduced, and the implantation is safer.

In the anchor assembly 34, the attachment ring may be a circular ring or an elliptical ring, and the shape of its axial cross-section may be circular or elliptical; similarly, the threading ring 3454 may be a circular ring or an elliptical ring, and its axial cross section may be circular or elliptical. In the illustrated embodiment, the attachment ring and the threader 3454 are both circular rings and both have a circular cross-sectional shape.

To ensure safety after implantation, the anchor assembly 34 is generally made of a material having good biocompatibility, including but not limited to a metallic material (e.g., stainless steel) or a polymeric material (e.g., PEEK, PET). Among them, anchor 3414 and anchor 3412 are preferably made of stainless steel having high hardness. The connection ring and the threading ring 3454 may be made of stainless steel or polymer (e.g., PEEK or PET). For example, a stainless steel wire may be looped around the supporting portion 3413 of the anchor 3414, both ends of the stainless steel wire are fixed by spot welding or both ends of the stainless steel wire are fixed by crimping through a sleeve to form a connecting ring, and then another stainless steel wire is threaded through the connecting ring, both ends of the stainless steel wire are fixed by spot welding or both ends of the stainless steel wire are fixed by crimping through a sleeve to form the threading ring 3454. Preferably, the connection ring and/or the threading ring 3454 may be made of a flexible polymer material, which can be twisted to facilitate the rotation thereof.

Referring to fig. 6, 14 and 15, in some embodiments, the connecting component 3452 includes a mounting portion 3451 and a connecting portion 3453 connected to the mounting portion 3451, the mounting portion 3451 is movably sleeved on the supporting portion 3413 of the anchor block 3414, and the threading ring 3454 is movably connected to the connecting portion 3453. Specifically, the fitting portion 3451 is opened with a fitting hole 3457, and the connecting portion 3453 is opened with a connecting hole 3459. The fitting portion 3451 is movably fitted over the supporting portion 3413 of the anchor block 3414 through the fitting hole 3457, and the threading ring 3454 is movably coupled to the coupling hole 3459 of the coupling portion 3453. Here, the fitting portion 3451 is clearance-fitted with the support post of the support portion 3413, so that the connection member 3452 is rotatable about the central axis a of the anchor 341 by 360 degrees, i.e., the connection member 3452 includes a rotational degree of freedom about the central axis a of the anchor 341. The cable tie 3454 may have two degrees of freedom, including rotational freedom to rotate about its central axis D and rotational freedom to yaw left and right about a third radial axis E parallel to the central axis A of the anchor 341. The threading ring 3454 can deflect left and right around the third radial axis E, and the relative left and right deflection can reach 180 degrees (the third radial axis E is used as a rotation axis, and can deflect 90 degrees left and 90 degrees right).

Further, connecting groove 3411 of support portion 3413 has an axial width greater than the axial thickness of fitting portion 3451, preferably 2 to 3 times the axial thickness of fitting portion 3451, so that connecting member 3452 is movable in the axial direction of anchor member 341, i.e., has a translational degree of freedom of movement in the axial direction of anchor member 341.

It can be understood that the connecting member 3452 can rotate around the central axis a of the anchoring member 341, the threading ring 3454 can move to the state after the tightening wire 32 is tightened under the action of the tightening force when the tightening wire 32 is tightened, the threading direction of the threading ring 3454 can be along the circumferential direction of the valve ring or ventricular wall, so that the resistance of the tightening process of the tightening wire 32 is greatly reduced, the tightening wire 32 does not have the bending condition, and the tightening is stable and smooth. Connecting member 3452 is movable in the axial direction of anchor 341, and when the anchoring depth of anchoring portions 3412 of multiple anchor assemblies 34 is not uniform, tightening wire 32 can be pulled to move connecting member 3452 up and down in the axial direction, so that the bending of tightening wire 32 is further reduced, and tightening wire 32 can be distributed on the same plane as much as possible, and can be tightened stably and smoothly. The threading ring 3454 is movable, and the direction adjustment by the connecting component 3452 can reduce the tightening resistance of the tightening thread 32. Thus, the anchoring assembly 34 may also provide stability to the constricted or constricted ventricle, which is effective.

Referring to fig. 7 and 16, in some embodiments, the threading structure 345 of the anchor assembly 34 includes a threading ring attached to the proximal end of the flexible sheath 343 for receiving the tensioning wire 32. Thus, threading structure 345 is not provided on anchor element 341, anchor element 341 can omit anchor seat 3414 or anchor seat 3414 can be designed to be smaller in volume, reducing the overall volume of anchor assembly 34. Wherein the threading ring may be sutured to the proximal end of the flexible sheath 343 by a suture.

It can be understood that, since the flexible sheath 343 is rotatable with respect to the anchor 341 and the flexible sheath 343 has flexibility, after a plurality of anchor assemblies 34 implanted in heart tissue such as the annulus or the ventricular wall are respectively connected to receive the tightening wire 32 through the thimble, when the tightening wire 32 is tightened, the thimble of the anchor assembly 34 can move under the tension of the tightening wire 32 to a state in which the tightening wire 32 is tightened, the thimble of each anchor assembly 34 can move so that the threading direction thereof is along the circumferential direction of the annulus or the ventricular wall, so that the tightening wire 32 forms a C-shape smoothly, the resistance of the tightening wire 32 in the tightening direction is greatly reduced, and the tightening wire 32 is tightened stably and smoothly. Moreover, because the thimble is connected at the near end of the flexible sheath 343, the distance between the thimble and the heart tissue is closer, can reduce because tighten up the too far contraction stroke loss that brings of dirty tissue of line 32 centrifugation, has improved the tightening effect of tighten up line 32.

It should be noted that, in the present application, the threading structure 345 of the anchor assembly 34 may further include a threading aperture formed in the anchor 341 for receiving the tensioning wire 32. For example, a threading hole may be provided in anchor seat 3414 of anchor 341. In other embodiments, the anchor assembly 34 can omit the threading structure 345 and the tightening wire 32 can be coupled to the anchor assembly 34 directly through the flexible sheath 343.

Referring also to fig. 17-19, the distal end of the anchor assembly 10 is removably attached to the anchor assembly 34. In some embodiments, anchoring device 10 includes a drive tube 12 and a connecting rod 14 inserted into drive tube 12, the distal end of drive tube 12 is provided with a second connecting portion 122 detachably connected to first connecting portion 3415 of anchor block 3414, connecting rod 14 is axially inserted into first connecting portion 3415 and second connecting portion 122 in mating connection to hold anchor assembly 34 connected to drive tube 12, and drive tube 12 is used to deliver and drive anchor 341 (i.e., anchor 3412) to be anchored to heart tissue.

The first connecting portion 3415 and the second connecting portion 122 are respectively a connecting portion with an S-shaped buckling curved surface disposed at the proximal end of the anchoring portion 3414 and the distal end of the driving tube 12, and each of the connecting portions has an inner cavity. As shown in fig. 17, when the first connecting portion 3415 and the second connecting portion 122 are connected, the connecting seats of the anchor seat 3414 and the driving tube 12 are engaged, the inner cavities of the two connecting seats are connected, the distal end of the connecting rod 14 inserted into the driving tube 12 extends from the distal end of the driving tube 12 and is inserted into the inner cavities of the two connecting seats, so as to limit the separation of the first connecting portion 3415 and the second connecting portion 122, so that the anchor assembly 34 is connected to the driving tube 12, and the driving tube 12 is rotated to rotate the anchor 341, so that the anchor portion 3412 is anchored in the heart tissue. It will be appreciated that as the distal ends of connecting rods 14 are withdrawn from the abutting engagement of first connecting portions 3415 and second connecting portions 122, first connecting portions 3415 and second connecting portions 122 may be separated, thereby effecting separation of anchor assembly 34 from drive tube 12. The anchoring device 10 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 first connecting portion 3415 and the second connecting portion 122 may be connecting portions with other structures, such as a mating structure of a latch and a slot, which is not limited herein. The anchoring device 10 may also be composed of the driving tube 12 and a connecting tube sleeved outside the driving tube 12, and the distal end of the connecting tube is sleeved outside the first connecting portion 3415 and the second connecting portion 122 which are connected in a matching manner, and may also function to limit the separation of the first connecting portion 3415 and the second connecting portion 122.

Referring again to fig. 1, the anchor assembly 34 is removably connected to the anchor assembly 10 and the tensioning wire 32 is integrally threaded into the delivery sheath 52 after being connected to the anchor assembly 34. Thus, the multiple anchor assemblies 34 of the implant 30 can be sequentially delivered to the heart tissue, such as the annulus or ventricular wall, through the delivery sheath 52.

As previously discussed, the tightening wire 32 can be coupled to the anchor assembly 34 via a threading structure 345 provided on the anchor 341 or on the flexible sheath 343, or the tightening wire 32 can be coupled to the anchor assembly 34 directly through the flexible sheath 343. When the cinch line 32 is coupled to the anchor assemblies 34 by a threading structure 345 provided on the anchors 341 or flexible sheath 343, the threading structure 345 may include a threading ring 3454, and the threading ring 3454 of the first anchor assembly 34 anchored to the heart tissue is fixedly coupled to one end of the cinch line 32. Specifically, referring to FIG. 20, after the cinch line 32 is threaded through the loop 3454 of the first anchor assembly 34, one end of the cinch line 32 is secured by the crimp tube 33, and the crimp tube 33 cannot pass through the loop 3454. The pressure tube 33 may be made of a metallic material (e.g., stainless steel) having good biocompatibility, and is pressed by a press machine to fix one end of the tightening wire 32. Preferably, the pressure tube 33 is entirely surrounded by a covering film to reduce the risk of damage to heart tissue, such as the annulus or ventricular wall, by the pressure tube 33.

Referring to fig. 2 and 3, in some embodiments, implant 30 further includes at least one spacer 36, where spacer 36 is threaded onto tightening wire 32, and where spacer 36 is positioned between two anchor assemblies 34. The spacer 36 prevents the tightening wire 32 from being tightened too much, which may cause the distance between two adjacent anchor assemblies 34 to be too short and damage the annulus or ventricular wall, and the spacer 36 can serve as a cushion to distribute the tightening force applied to the anchor assemblies 34 and ensure stable implantation of the anchor assemblies 34. The spacer 36 is a cylinder with a certain length, and is preferably made of a biocompatible material. The spacer 36 may be wrapped with a covering membrane to reduce the risk of heart tissue, such as the annulus or ventricular wall, being damaged by the spacer 36.

Optionally, a spacer 36 (as shown in fig. 2 and 3) may be disposed between any two adjacent anchor assemblies 34 of the plurality of anchor assemblies 34 of the implant 30, or a spacer 36 may be disposed every two or more anchor assemblies 34, which is not limited thereto.

Referring to fig. 21 and 22 together, in some embodiments, the transcatheter cardiac repair system 1 further includes a pusher 90 for pushing the spacer 36. Specifically, 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 movably pass through, the pushing member 90 pushes the spacer 36 along the tightening wire 32 into the second guiding sheath 72 of the guiding device 70, and the delivery sheath 52 is threaded in the second guiding sheath 72 to push the spacer 36 in the second guiding sheath 72.

It will be appreciated that after implanting the first anchor assembly 34 in the heart tissue, such as the annulus or ventricular wall, the delivery sheath 52 and the anchoring device 10 are withdrawn, and after threading the proximal end of the tensioning wire 32 through the spacer 36 and threading the tensioning wire 32 through the threading hole 92 of the pusher 90 in the threading direction a, the pusher 90 pushes the spacer 36 along the tensioning wire 32 in the pushing direction b into the second guiding sheath 72 of the guiding device 70. The second anchor assembly 34 is then assembled with the anchoring device 10 and the tensioning wire 32 is threaded through the second anchor assembly 34 through the loop 3454 and into the delivery sheath 52, the delivery sheath 52 is further threaded into the second guide sheath 72, and the spacer 36 is positioned on the distal side of the delivery sheath 52. Thus, the delivery sheath 52 is moved axially distally within the second guide sheath 72 to advance the spacer 36 to the heart tissue, such as the annulus or ventricular wall, and the anchoring device 10 then advances the second anchor assembly 34 out of the delivery sheath 52 and anchors the second anchor assembly 34 into the annulus or ventricular wall so that the spacer 36 is positioned between the two anchor assemblies 34. The same procedure is repeated, with multiple anchor assemblies 34 being sequentially implanted into cardiac tissue, such as the annulus or ventricular wall, with spacers 36 being sequentially inserted between each two or more anchor assemblies 34. Wherein the distance between two adjacent anchor assemblies 34 needs to be greater than the axial length of the spacer 36.

Referring again to fig. 1-3, in some embodiments, the delivery device 50 further includes a delivery wire 54, one end of the cinch wire 32 is fixedly coupled to the first anchor assembly 34 that is anchored to the heart tissue, the delivery wire 54 is coupled to the other end of the cinch wire 32, and the delivery wire 54 extends out of the body. The anchor assembly 34 is threaded onto the puller wire 32 prior to implantation of the anchor assembly 34 by delivery through the delivery wire 54.

Referring to fig. 2 and 3, in some embodiments, the implant 30 further includes a wire retractor 38, the wire retractor 38 being configured to adjust and lock the cinch wire 32. Referring to fig. 1, the transcatheter cardiac repair system 1 further includes an adjustment device 80 for delivering and controlling the take-up reel 38. It will be appreciated that the transfer wire 54 is connected to the tightening wire 32, and the tightening wire 32 is connected to the anchor assembly 34 and the spacer 36 via the transfer wire 54 extending outside the body, and the length of the tightening wire 32 can be designed to be short, and the adjustment device 80 controls the wire drawer 38 to adjust the length of the tightening wire 32 and lock the tightening wire 32 without cutting the tightening wire 32.

Specifically, the other end of the tightening wire 32 is folded in half to form a U-shape, and the conveying wire 54 passes through the folded portion of the tightening wire 32 to be detachably connected. After implanting the plurality of anchor assemblies 34 and spacers 36 in the heart tissue, the take-up device 38 is threaded over the puller wire 32 along the delivery wire 54, and the puller wire 32 is then tightened and tightened against the puller wire 32 using the take-up device 38, the delivery wire 54 is withdrawn, the puller wire 32 is released, and the constriction is completed or the ventricle is narrowed to relieve the regurgitation of blood. When the delivery wire 54 is non-removably attached to the tightening wire 32, the delivery wire 54 may be removed from the body by shearing the delivery wire 54.

Referring to fig. 23 to 26, in some embodiments, the wire winding device 38 includes a housing 381 and a winding shaft 383 rotatably disposed in the housing 381. Since the wire 54 is connected to the wire 32, the wire rewinding device 38 is threaded on the wire 54 and moves toward the distal end of the wire 54 to movably pass the other end of the wire 32 through the housing 381 and the spool 383, the spool 383 rotates relative to the housing 381 to wind the wire 32, and the wire 32 is locked in the radial space between the spool 383 and the housing 381 when the spool 383 stops rotating.

The adjusting device 80 includes a threaded rod 82, a rotating shaft 84 and an outer sheath 86. The threaded rod 82 is used for being in threaded connection with the spool 383, the rotating shaft 84 is used for being clamped with the spool 383 and driving the spool 383 to rotate relative to the shell 381, and the outer sheath tube 86 is clamped with the shell 381 and used for fixing the shell 381 to prevent the shell 381 from rotating along with the spool 383.

Specifically, as shown in fig. 23, the casing 381 includes a hollow casing 3812 with a distal end opening, a bottom casing 3814 connected to and packaged in the distal end opening of the casing 3812, and a meshing tooth 3816 convexly disposed at a proximal end of the casing 3812, the casing 3812 and the bottom casing 3814 are enclosed to form an accommodating cavity for accommodating the winding shaft 383, wherein a through hole communicating with the accommodating cavity is opened at the proximal end of the casing 3812, and the meshing tooth 3816 is circumferentially disposed at intervals along the through hole. A pair of first threading holes is formed in the side wall of the housing 3812. As shown in fig. 24 and 25, the winding shaft 383 includes a main body 3832 which is substantially "i" shaped, the main body 3832 is provided with a winding groove 3834, a second threading hole is formed in a portion of the main body 3832 surrounded by the winding groove 3834, a protrusion 3836 is convexly provided at a proximal end of the main body 3832, and an internal thread hole extending along an axial direction is formed in the protrusion 3836 and is adapted to an external thread at a distal end of the threaded rod 82.

When the winding shaft 383 is accommodated in the accommodating cavity of the casing 381, the pair of first threading holes of the casing 3812 is aligned with the second threading holes of the winding shaft 383 so as to allow the conveying wire 54 and the tightening wire 32 to pass through, and an accommodating space is formed by the inner wall of the casing 3812 and the winding groove 3834 of the main body 3832 to accommodate the tightening wire 32 wound by the winding shaft 383. A boss 3836 at the proximal end of the spool 383 extends through a through hole in the proximal end of the housing 3812 for threaded engagement with the threaded rod 82 and for snap engagement with the rotating shaft 84. It should be noted that, the distal end of the outer sheath tube 86 of the adjusting device 80 is provided with a meshing tooth corresponding to the meshing tooth 3816 at the proximal end of the outer sheath 3812, the meshing tooth at the distal end of the outer sheath tube 86 and the meshing tooth 3816 at the proximal end of the outer sheath 3812 are meshed with each other to fix the housing 381, and the rotation shaft 84 clamped with the winding shaft 383 is rotated to drive the winding shaft 383 to rotate relative to the housing 381, so that the winding wire 32 passing through the winding machine 38 can be wound, thereby realizing ring shrinkage.

Further, a stopper mechanism is provided between the distal end of the spool 383 and the bottom case 3814 of the housing 381, and allows the spool 383 to rotate in the forward direction with respect to the housing 381 to wind the takeup wire 32 passing through the takeup reel 38, and restricts the spool 383 from rotating in the reverse direction with respect to the housing 381, so that the takeup wire 32 is locked when the rotation of the spool 383 is stopped.

The proximal end of the bottom housing 3814 is provided with a first stopper 3818, the distal end of the spool 383 is provided with a second stopper 3838 corresponding to the first stopper 3818, and the first stopper 3818 and the second stopper 3838 cooperate to realize unidirectional rotation of the spool 383 relative to the housing 381. Specifically, the first stopper portion 3818 and the second stopper portion 3838 are a plurality of helical tooth structures distributed along the circumferential direction of the proximal end surface of the bottom case 3814 and the circumferential direction of the distal end surface of the winding shaft 383, and the helical teeth are engaged to enable the winding shaft 383 to rotate only in one direction.

Due to the helical tooth structure for stopping, when the spool 383 rotates relative to the housing 381, the spool 383 floats in the housing 381 along the axial direction of the housing 381 together. An elastic member 385 is further disposed between the proximal end of the spool 383 and the outer shell of the housing 381 to ensure smooth movement of the spool 383 relative to the housing 381. The elastic member 385 may be a spring, a tubular elastic sheet, an elastic bellows, etc., and is preferably a spring.

In other embodiments, the first stopper portion 3818 and the second stopper portion 3838 may also be a combination of structures that can realize unidirectional rotation, such as a spring and a slot, which is not limited to this.

It is understood that in other embodiments, the delivery device 50 may omit the delivery wire 54, the length of the tightening wire 32 is long enough to extend to the outside of the patient, and after implanting a plurality of anchor assemblies 34, the tightening wire 32 is contracted to achieve the preferred effect of reducing blood reflux, and then the tightening wire 32 can be trimmed by a knot locking device of the prior art, such as knot locking or nail locking, which will not be described in detail herein.

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 heart repair system 1 further have corresponding control handles, and the structure thereof is substantially similar to the structure of the handle in the prior art, and the details thereof are not described herein.

The use of the transcatheter cardiac repair system 1 for mitral valve annuloplasty will now be described with reference to fig. 2, 3 and 27-30. Wherein, the operation path is as follows: transfemoral-inferior vena cava-Right Atrium (RA) -interatrial septum (AS) -Left Atrium (LA) -Mitral Valve (MV) annulus.

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

Second, as shown in fig. 27, the guide device 70 is advanced over the guide wire until its distal end passes through the foramen ovale to the left atrium and to the vicinity of the valve annulus, and the guide wire is withdrawn.

Third, as shown in fig. 28, the threading ring 3454 of the first anchor assembly 34 is fixedly connected to one end of the tightening wire 32, the other end of the tightening wire 32 is detachably connected to the transmission wire 54, the first anchor assembly 34 and the anchor device 10 are assembled and then threaded into the delivery sheath 52 together with the tightening wire 32 and the transmission wire 54, and the delivery sheath 52 is moved axially and distally in the guiding device 70 until the distal end abuts against the valve annulus. As shown in fig. 29, the first anchor assembly 34 is then implanted in the annulus of the mitral valve using the anchor device 10 threaded into the delivery sheath 52. The flexible sheath 343 covers the anchoring portion 3412, so that the anchoring element 341 can be prevented from scratching the delivery sheath 52 during delivery, and the anchoring element 341 can be prevented from being wound with the tightening wire 32 and the delivery wire 54 during implantation, thereby improving the safety of the operation. As shown in fig. 30, after anchor 3412 is anchored to the annulus, flexible sheath 343 is compressively deformed to compress between the anchor seat and the mitral annulus.

Fourth, after implanting the first anchor assembly 34, the anchoring device 10 and delivery sheath 52 are withdrawn, the spacer 36 is introduced into the guide device 70 via delivery wire 54 and pusher 90, the anchoring device 10 with the second anchor assembly 34 assembled is threaded into the delivery sheath 52 and advanced along the guide device 70 into the left atrium, while the spacer 36 is advanced by advancing the delivery sheath 52 to the vicinity of the valve annulus, and the spacer 36 is advanced out of the guide device 70 between the first anchor assembly 34 and the second anchor assembly 34. Under ultrasound and Digital Subtraction Angiography (DSA) images, the control guide 70 and the anchoring device 10 adjust the position of the second anchor assembly 34 according to the size of the diseased annulus, and the second anchor assembly 34 is implanted. The distance between the second anchor assembly 34 and the first anchor assembly 34 needs to be greater than the axial length of the spacer 36.

In a fifth step, the fourth step is repeated, sequentially implanting the anchor assemblies 34 and spacers 36 from anterior to posterior trigones of the mitral valve, sequentially from posterior to posterior trigones, or vice versa, such that the anchor assemblies 34 and spacers 36 are evenly distributed over the annulus (as shown in fig. 2), and after a sufficient number of anchor assemblies 34 have been implanted, withdrawing the anchoring device 10 and delivery sheath 52.

Sixthly, the wire winder 38 is connected to the distal end of the adjusting device 80, the proximal end of the transmission wire 54 is passed through the wire winder 38, the wire winder 38 is fed to the mitral valve annulus through the guiding device 70, the rotating shaft 84 of the adjusting device 80 is rotated forward, the winding shaft 383 of the wire winder 38 is wound around the tightening wire 32 to shorten the length of the tightening wire 32, so as to shrink the valve annulus, after a good ring shrinking effect is achieved, the tightening wire 32 is locked, the threaded rod 82 is rotated backward, the wire winder 38 is disengaged from the adjusting device 80 so as to withdraw the adjusting device 80, so that the implant 30 is left on the valve annulus (as shown in fig. 3), and the ring shrinking operation is completed.

It should be noted that there is a lower probability of crimping during implantation of the anchor assembly 34, and that the DSA and ultrasound images may be combined by rotating the drive tube 12 of the anchor device 10 in the opposite direction to unscrew the anchor assembly 34, and thereby free the cinch line 32, and then retightening the anchor assembly 34 for implantation.

It is understood that, in other embodiments, the transcatheter heart repair system 1 provided by the present application may also be applied to tricuspid valve annuloplasty, and may also be applied to implant a plurality of anchor assemblies 34 connected in series by tightening the strings 32 in the left ventricular wall or the right ventricular wall, and the tightening of the strings 32 is used to achieve a procedure of narrowing the ventricle, which will not be described in detail herein.

The foregoing is an implementation of the embodiments of the present application, and it should be noted that, for those skilled in the art, several modifications and decorations can be made without departing from the principle of the embodiments of the present application, and these modifications and decorations are also regarded as the protection scope of the present application.

Claims

1. An anchor assembly for a wire wrap, comprising:

an anchor comprising an anchoring portion for anchoring into human tissue; and

a flexible sheath wrapped around an exterior of the anchor portion;

wherein the anchor assembly is coupled to receive a tension line.

2. The wire-wrap anchor assembly of claim 1, wherein an axial length of the flexible sheath is greater than or equal to an axial length of the anchoring portion.

3. The wire-wrap resistant anchor assembly of claim 2 wherein said flexible sheath has an inner lumen having a radial dimension greater than an outer diameter of said anchoring portion, said anchor rotating relative to said flexible sheath during anchoring of said anchoring portion into said body tissue.

4. The anti-wind anchor assembly of claim 3, wherein the proximal end of the flexible sheath defines a through hole, the anchor portion being received in the lumen of the flexible sheath through the through hole, the distal end of the flexible sheath being open or closed.

5. The anti-wind anchor assembly as in claim 4, wherein said anchor further comprises an anchor seat connected to a proximal end of said anchor portion, a distal end of said anchor seat having a socket portion fixedly connected to said proximal end of said anchor portion;

the aperture of the through hole is matched with the outer diameter of the insertion part, and the near end of the flexible sheath is clamped with the insertion part.

6. The wire-wrap resistant anchor assembly of claim 5 wherein said flexible sheath is formed of a biocompatible flexible material;

when the anchoring part is anchored into the human tissue, the flexible sheath is compressed and deformed to be extruded between the anchoring seat and the human tissue.

7. The wire-wrap resistant anchor assembly of any one of claims 1-6, wherein the anchor assembly further comprises a threading structure disposed on the anchor or on the flexible sheath, the threading structure for connecting the cinch wire.

8. The anti-wind anchor assembly as in claim 7, wherein said threading structure comprises a threading ring attached to a proximal end of said flexible sheath, said threading ring for attaching said cinch line; alternatively, the first and second electrodes may be,

the threading structure comprises a threading hole arranged on the anchoring piece, and the threading hole is used for connecting the tightening line.

9. The anchor assembly of claim 7, wherein the threading structure includes a connector and a collar movably coupled to the connector, the connector being movably sleeved on the anchor, the collar being configured to couple to the cinch line;

wherein the connecting member has at least one degree of freedom, one of the degrees of freedom of the connecting member being a rotational degree of freedom of rotation of the connecting member about a central axis of the anchor.

10. The wire-wrap anchor assembly of claim 9, wherein the connector has at least two degrees of freedom, the degrees of freedom of the connector further including translational degrees of freedom for axial movement along the anchor.

11. The wire-defense anchor assembly of claim 10 wherein the connector includes first and second radial axes that are perpendicular to each other, the degrees of freedom of the connector further including rotational degrees of freedom about the first radial axis and translational degrees of freedom to move along the second radial axis.

12. The wire-wrap resistant anchor assembly of claim 9 wherein the grommet includes a third radial axis parallel to the anchor central axis, the grommet having degrees of freedom including rotational degrees of freedom about its central axis and rotational degrees of freedom about the third radial axis.

13. An implant, wherein the implant comprises a cinch cord and a plurality of anti-wind anchor assemblies as claimed in any one of claims 1 to 12, the plurality of anchor assemblies being connected by the cinch cord and each for anchoring into cardiac tissue;

one end of the cinch cord is fixedly coupled to a first of the anchor assemblies anchored to the heart tissue and the other end is slidably threaded through the other anchor assemblies anchored to the heart tissue.

14. The implant of claim 13, further comprising at least one spacer threaded onto the cinch wire, the spacer positioned between the two anchor assemblies.

15. The implant of claim 13 or 14, further comprising a take-up including a housing and a spool rotatably disposed within the housing, the other 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 locked in a radial space between the spool and the housing when the spool stops rotating.

16. A transcatheter cardiac repair system comprising an anchoring device and an implant according to claim 13, wherein the anchoring device comprises a driving tube and a connecting rod inserted into the driving tube, the anchoring device has a first connecting portion at a proximal end thereof, the driving tube has a second connecting portion at a distal end thereof for detachable connection to the first connecting portion, the connecting rod is axially inserted into the first connecting portion and the second connecting portion for mating connection to connect the anchoring assembly to the anchoring device, and the driving tube is configured to drive the anchoring device to anchor into the cardiac tissue.

17. The transcatheter cardiac repair system of claim 16, further comprising a delivery device for delivering the implant to the cardiac tissue, the delivery device including a delivery sheath, the anchor assembly removably coupled to the anchor device and the cinch wire integrally threaded through the delivery sheath after being coupled to the anchor assembly.

18. The transcatheter cardiac repair system of claim 17, further comprising an introducer device and a pusher, the introducer device comprising at least one introducer sheath, the implant further comprising at least one spacer;

the far end of the pushing element is provided with a threading hole for the near end of the tightening wire to movably pass through, the pushing element pushes the spacer into the guiding sheath along the tightening wire, and the conveying sheath is arranged in the guiding sheath in a penetrating mode so as to push the spacer in the guiding sheath.

19. The transcatheter cardiac repair system of claim 17, wherein the delivery device further comprises a delivery wire connected to the other end of the cinch wire.

20. The transcatheter cardiac repair system of claim 19, wherein the implant further comprises a take-up including a housing and a spool rotatably disposed within the housing, the take-up moving toward the distal end of the delivery wire to movably pass the other end of the cinch wire through the housing and the spool, the spool rotating relative to the housing to wind the cinch wire, the cinch wire being locked within a radial space between the spool and the housing when the spool stops rotating.