CN116942370A

CN116942370A - Anti-drop anchor, implant, and transcatheter crimping system

Info

Publication number: CN116942370A
Application number: CN202310744641.7A
Authority: CN
Inventors: 郭荣辉; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2023-06-21
Filing date: 2023-06-21
Publication date: 2023-10-27

Abstract

The application provides an anti-falling anchoring piece, an implant and a transcatheter annular shrinking system, wherein the anchoring piece comprises a screw nail and a nail seat connected to the proximal end of the screw nail, the screw nail is configured to be anchored into target tissue, the screw nail spirally extends from the nail seat to the distal end, the axial length of the screw nail ranges from 4mm to 5.4mm, and the radial width of the screw nail ranges from 2.6mm to 4mm. The screw nail is arranged to be short and fat, the anchoring force is stronger, the anchoring piece can be prevented from falling off from the target tissue, and the implantation is safer.

Description

Anti-drop anchor, implant, and transcatheter crimping system

Technical Field

The application relates to the technical field of medical instruments, in particular to an anti-falling anchoring piece, an implant and a transcatheter ring shrinking system.

Background

Mitral Regurgitation (MR) is a common heart valve disorder, including primary and secondary mitral regurgitation. Primary mitral regurgitation is a malfunction of the anterior and posterior mitral valves She Wenge due to abnormal mitral valve leaflets, chordae tendineae fracture or papillary muscle dysfunction, and secondary mitral regurgitation is a malfunction of the anterior and posterior mitral valves She Wenge due to dilation of the annulus, enlargement of the left atrium and left ventricle.

Mitral valve intervention has evolved rapidly in recent years, mainly including valve repair or valve replacement. Among them, mitral valve annuloplasty is a common prosthetic procedure that reduces mitral regurgitation by reducing the size of the patient's annulus.

In the prior art, the anchors implanted in the mitral valve annulus are typically long narrow helical nails, which are typically sized long and narrow, and after the anchors are implanted in the annulus, the long narrow anchors tend to loosen or fall off the annulus of the mitral valve due to the constant beating of the heart, resulting in failure of the procedure.

Disclosure of Invention

To achieve the above object, in one aspect, the present application provides an anti-falling anchor, the anchor comprising a screw and a screw seat connected to a proximal end of the screw, the screw being configured to anchor into a target tissue, the screw extending helically from the screw seat to a distal end, an axial length of the screw ranging from 4mm to 5.4mm, and a radial width of the screw ranging from 2.6mm to 4mm.

The number of turns of the screw comprises at least three turns, the pitch of the screw comprises a first pitch and a second pitch, and the first pitch is smaller than the second pitch.

The anchor further comprises an anchor hook arranged on the screw nail, and an included angle between the anchor hook and the screw nail is 30-60 degrees.

At least one spiral turn of the spiral nail is provided with 2-6 anchor hooks, and the surfaces of the anchor hooks are rough.

The section of the spiral ring of the spiral nail is elliptical, and the ratio of the major axis size to the minor axis size of the ellipse ranges from 2 to 3.

At least one spiral ring of the spiral nail is provided with at least one through hole.

The width of the through hole is not more than one third of the thickness of each spiral turn of the spiral nail.

The screw nail comprises a bending part, a screw part and a distal tip from a proximal end to a distal end in sequence, wherein the bending part comprises a plurality of arc sections which are sequentially and smoothly connected, and the projection of the bending part from the proximal end to the distal end is an arc.

The anchor further comprises a threading structure movably sleeved on the nail seat, the threading structure is provided with a threading hole, and the threading hole is configured for the flexible slender piece to pass through.

In another aspect, the present application also provides an implant comprising: a plurality of the above-described anti-drop anchors; a flexible elongate member connecting a plurality of the anchors, the flexible elongate member configured to adjust a spacing between the plurality of anchors; and a lock connected to the flexible elongate member, the lock configured to lock a length of the flexible elongate member to maintain tension of the flexible elongate member.

The implant further comprises at least one spacer movably connected to the flexible elongate member, the spacer being disposed between at least some adjacent two of the anchors.

In yet another aspect, the present application also provides a transcatheter ring retraction system comprising an anchor device, a delivery device, and an implant as described above, the distal end of the anchor device being removably coupled to the anchor, the delivery device being configured to deliver the anchor to the target tissue, the anchor device being configured to drive the helical screw to anchor into the target tissue.

Different from the size and the structure of the anchoring piece in the prior art, the screw nail of the anchoring piece provided by the application adopts a specific anti-falling size and various anti-falling structure designs, thereby ensuring that the anchoring piece is not easy to fall off when being implanted into beating heart tissue for a long time. In the anti-falling anchoring piece, the implant and the transcatheter annular shrinking system, the axial length range of the screw nail adopted by the anchoring piece is 4mm-5.4mm, the radial width range is 2.6mm-4mm, the screw nail is arranged to be short and fat, the anchoring force is stronger, the anchoring piece can be prevented from falling off from target tissues, and the implantation is safer.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present application, and other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic structural view of a transcatheter annular system according to an embodiment of the present application.

Fig. 2 is a schematic view of an implant according to an embodiment of the present application implanted in an annulus and with the flexible elongate member locked in place.

Fig. 3 is a schematic perspective view of the anchor of fig. 1.

Fig. 4 is an exploded view of the anchor of fig. 3.

Fig. 5 is a schematic perspective view of the screw in fig. 4.

Fig. 6 is a top view of the screw of fig. 5.

Fig. 7 is a schematic view of the structure of a screw according to another embodiment of the present application.

Fig. 8 is a schematic view of the structure of the screw provided with the fluke according to the present application.

Fig. 9 is an enlarged view of a in fig. 8.

Fig. 10 is a schematic view of another screw provided with an anchor hook according to the present application.

Fig. 11 is an enlarged view of B in fig. 10.

Fig. 12 is a schematic view of the structure of a screw according to still another embodiment of the present application.

Fig. 13 is a sectional view in the direction B-B of fig. 12.

Fig. 14 is a schematic view showing the structure of a screw according to still another embodiment of the present application.

Fig. 15 is an enlarged view of C in fig. 14.

Fig. 16 is a perspective view of an anchor device in connection with an anchor according to an embodiment of the present application.

Fig. 17 is a schematic view of a screw anchored into a target tissue.

Fig. 18 is a structural perspective view of the guide device.

Fig. 19 is a cross-sectional view of the connection of the delivery sheath to the secondary introducer sheath.

Fig. 20 is a schematic view of the attachment of the flexible elongate member to the delivery member.

Fig. 21-23 are perspective views of a use procedure of a transcatheter annular system according to one embodiment of the present application.

The application will be further illustrated by the following specific examples in conjunction with the above-described figures.

Detailed Description

The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the application. All other embodiments, which can be made by a person skilled in the art based on the embodiments of the application without any inventive effort, are intended to fall within the scope of the application.

Furthermore, the following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the application may be practiced. Directional terms, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., in the present application are merely referring to directions of the attached drawings, and thus, the directional terms are used for better, more clear explanation and understanding of the present application, rather than indicating or implying that the apparatus or element being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present application.

It should be noted that, in order to more clearly describe the structure of the anti-falling anchor, implant and transcatheter annular system provided by the present application, the terms "proximal" and "distal" are defined in the specification as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end that is distal to the operator during a surgical procedure, and "proximal" refers to the end that is proximal to the operator during a surgical procedure; the direction of the rotation central axis of the column body, the tube body and other objects is defined as an axial direction; the circumferential direction is the direction (perpendicular to the axis and the radius of the section) around the axis of the cylinder, the pipe body and the like; radial is the direction along the diameter or radius.

It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a location extending an axial distance and/or a radial distance from the tip, endpoint or end face over the element to which the tip, endpoint or end face belongs. 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 application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

Referring to fig. 1-2, the present application provides a transcatheter annuloplasty system 1 configured to perform an annuloplasty on the mitral or tricuspid valve annulus to reduce regurgitation in blood. In particular, the transcatheter annular system 1 comprises an anchoring device 10, an implant 30, and a delivery device 50. Wherein the implant 30 includes a flexible elongate member 32, a plurality of anchors 34, and a lock 38. The flexible elongate member 32 is connected to a plurality of anchors 34. Each anchor 34 is removably attached to the distal end of the anchor 10. Delivery device 50 is configured to deliver anchor 34 to a target tissue. The anchoring device 10 is configured to drive each anchor 34 to anchor into target tissue. The flexible elongate member 32 is configured to adjust the spacing between the plurality of anchors 34. A lock 38 is connected to the flexible elongate member 32, the lock 38 being configured to lock the length of the flexible elongate member 32 to maintain tension in the flexible elongate member 32.

It will be appreciated that the target tissue may be the mitral valve annulus, the tricuspid valve annulus, the left ventricular wall, the right ventricular wall, or the like. After the plurality of anchors 34 connected by the flexible elongate member 32 are anchored to the target tissue, tightening the flexible elongate member 32 can reduce the spacing between the plurality of anchors 34 and thereby reduce the annulus. The length of the flexible elongate member 32 can be locked by the lock 38 after the desired effect of narrowing the annulus is achieved to maintain tension on the flexible elongate member 32, thereby maintaining the effect of narrowing the annulus. When the anchor 34 and flexible elongate member 32 are implanted in the annulus, the annulus is contracted directly by tightening the flexible elongate member 32; when the anchor 34 and flexible elongate member 32 are implanted in the wall of the ventricle below the annulus, such as 0.5-2cm of the wall of the ventricle below the annulus, the reduction in volume of the ventricle can also be achieved by constricting the flexible elongate member 32 to constrict the ventricle. It should be noted that the volume reduction of the left ventricle can also treat ischemic heart failure.

The flexible elongate member 32 may be a wire, filament, rope, strip, ribbon, or the like having an axial length and having a flexible radial cross-sectional shape that may be circular, oblate, rectangular, square, or other shape, as the application is not limited in this regard. The flexible elongate member 32 can be made of a metallic or polymeric material, preferably a biocompatible material such as stainless steel 316L, tungsten, tantalum, nickel titanium, polyethylene, polyamide, polypropylene, polyurethane, and the like. Illustratively, the flexible elongate member 32 is an elongate wire, such as a wire, which may be braided from a plurality of wires.

Referring to fig. 3, in the present application, the anchor 34 includes a screw 341 and a holder 343 connected to a proximal end of the screw 341. The screw 341 is configured to anchor into the target tissue. The screw 341 is spirally extended distally from the screw seat 343. The axial length H0 of the screw 341 is in the range of 4mm to 5.4mm, and the radial width D0 of the screw 341 is in the range of 2.6mm to 4mm.

It will be appreciated that the axial length H0 of the screw 341 may range from 4mm to 5.4mm, such as 4mm, 4.5mm, 5mm, 5.4mm, or any other value between 4mm and 5.4 mm. The radial width D0 of the screw is in the range of 2.6mm-4mm, for example 2.6mm, 3mm, 3.5mm, 4mm or any other value between 2.6mm-4mm. The screw 341 is set to be "short-fat type", the anchoring force is stronger, the anchor 34 can be prevented from falling off from the target tissue, and implantation is safer.

The screw 341 is fixedly connected with the pin seat 343. The distal end of the anchoring device 10 is detachably connected with the nail seat 343, and the rotation of the anchoring device 10 drives the nail seat 343 and the screw 341 to rotate, so that the screw 341 is anchored in the tissue.

In some embodiments, referring to fig. 1-4, the anchor 34 further includes a threading structure 345. The threading structure 345 is movably sleeved on the nail seat 343. The threading structure 345 is provided with a threading hole 346. The threading aperture 346 is configured to allow the flexible elongate member 32 to pass therethrough. In this manner, the flexible elongate member 32 is coupled to the anchor 34 through the threaded aperture 346 of the threaded structure 345. The threading structure 345 can rotate relative to the nail seat 343, so that the threading structure 345 is prevented from rotating together when the anchor device 10 drives the nail seat 343 and the screw 341 to rotate, and the flexible elongated member 32 and the anchor 34 are prevented from being wound.

Specifically, the threading structure 345 may include a ring portion 342 and a thread loop 344 movably connected to the ring portion 342. The annular portion 342 is movably sleeved on the nail seat 343. The wire loop 344 defines a wire aperture 346. It will be appreciated that the annular portion 342 can rotate relative to the staple holder 343. The flexible elongate member 32 is connected to the anchor 34 by a wire loop 344. Each anchor 34 has a threading structure 345, and a plurality of anchors 34 are connected through flexible elongate member 32 and are driven in turn by anchor 10 into the target tissue.

As shown in fig. 2, the flexible elongate member 32 is attached at one end to the wire loop 344 of the first anchor 34 anchored to the target tissue and is slidable through the wire loops 344 of the other anchors 34 anchored to the target tissue.

In other embodiments, the threading structure 345 may include an annular portion 342 movably sleeved on a staple holder 343, the annular portion 342 defining a threading aperture 346.

In some embodiments, as shown in fig. 5, screw 341 includes a bend 3411, a helix 3413, and a distal tip 3415 in order from the proximal end to the distal end. The bent portion 3411 includes a plurality of arc-shaped segments connected in sequence in a smooth manner. As shown in fig. 6, the curved portion 3411 is projected as an arc from the proximal end to the distal end. In this way, the bent portion 3411 is smoothly transited, and no angle for concentrating the bending stress is obvious, so that the durability is improved, the probability of fracture of the screw 341 is reduced, and the anchor 34 is prevented from being partially broken and falling off.

In other embodiments, referring to fig. 8, 10 and 14, screw 341 may include only screw portion 3413 and distal tip 3415 without bend 3411.

In some embodiments, as shown in fig. 7, the number of turns of the screw 341 includes at least three turns. The screw 341 has a first pitch L1 and a second pitch L2, and the first pitch L1 is smaller than the second pitch L2. The first pitch L1 ranges from 0.6mm to 1.0mm, and the second pitch L2 ranges from 0.9mm to 1.5mm.

It will be appreciated that the first pitch L1 may range from 0.6mm to 1.0mm, for example from 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm or any other value between 0.6mm and 1.0 mm. The second pitch L2 ranges from 0.9mm to 1.5mm, for example from 0.9mm, 1mm, 1.3mm, 1.5mm or any other value between 0.9mm and 1.5mm. It will be appreciated that the screw 341 has a different pitch. The smaller first pitch L1 causes the target tissue to be more pressed, which in turn causes the target tissue to react more to the screw 341, causing more friction, thereby increasing the anchoring force of the screw 341 and preventing the screw 341 from falling off the target tissue. The larger second pitch L2 makes it easier for the screw 341 to anchor into the target tissue.

It is understood that the pitch refers to the distance between two adjacent turns of the screw 341 in the axial direction between the corresponding two points. The first pitch L1 and the second pitch L2 can be freely arranged and combined to form different pitch arrangement forms, which will not be described again.

In other embodiments, referring to fig. 5, 8, 10, 12 and 14, the screw 341 has equal pitch, i.e. the pitches between two adjacent screw turns are equal. The pitch L3 may range from 0.8mm to 1.5mm.

In some embodiments, referring to fig. 8 and 9, the anchor 34 further includes a hook 3412 provided to the screw 341. The angle alpha between the fluke 3412 and the screw 341 is in the range of 30 deg. -60 deg.. In this way, when the screw 341 is unscrewed from the target tissue, the anchor hook 3412 can hook the target tissue, and generate resistance to the unscrewing of the screw 341, thereby preventing the screw 341 from being detached from the target tissue, and enhancing the anchoring force of the anchor 34. The angle α between the fluke 3412 and the screw 341 is too small to enhance the anchoring force of the screw 341, and too large may make it difficult to screw the screw 341 into the target tissue. Accordingly, the angle α between the fluke 3412 and the screw 341 is preferably 30 ° -60 °.

At least one turn of screw 341 is provided with 2-6 flukes 3412. Specifically, one of the turns of the screw may be provided with 2-6 flukes 3412, or two or more turns of the screw may be provided with 2-6 flukes 3412. Preferably, each turn of screw 341 is provided with 2-6 flukes 3412. It will be appreciated that an excessive number of flukes 3412 tends to make it difficult to screw the screw 341 into the target tissue, and an insufficient number increases the anchoring force of the screw 341. Thus, it is preferable to provide 2-6 flukes 3412 per turn of screw 341. The axial height H1 of the fluke 3412 is preferably 0.15mm to 0.3mm. In one example, flukes 3412 are uniformly and symmetrically disposed on the proximally facing surface of screw 341.

Further, referring to fig. 10 and 11 together, the surface of fluke 3412 is roughened. Specifically, the surface of fluke 3412 is roughened serrated. The fluke 3412 having a rough serrated surface facilitates climbing of human tissue, further increases the anchoring force of the screw 341, and prevents the screw 341 from falling off from the target tissue. Of course, in other embodiments, the surface of fluke 3412 may be smooth.

In some embodiments, referring to fig. 12 and 13, the cross section of the turns of the screw 341 is elliptical. The major axis of the oval cross section is D2, the minor axis is D1, and the ratio of D2 to D1 is 2-3. It will be appreciated that the minor axis of the elliptical cross-section is parallel to the central axis of the screw 341 and the major axis is perpendicular to the central axis of the screw 341. When the screw 341 receives the axial pulling force F, since the contact area of the screw 341 with the target tissue is large, the upward pulling force F is a constant value according to the formula p=f/S, and the larger the force receiving area S, the smaller the pressure P, the smaller the force received by the target tissue, so that the risk of the anchor 34 falling off can be reduced.

In some embodiments, referring to fig. 14 and 15, at least one coil of the screw 341 is provided with at least one through hole 3414. Thus, after the screw 341 is anchored into the target tissue, the tissue can grow in the through hole 3414, and the tissue proliferated in the through hole 3414 and the external tissue form a closed loop connection, so that a pulling force can be generated on the screw 341 to prevent the screw 341 from sliding or even falling off.

Specifically, it may be that one of the turns of the screw 341 is provided with at least one through hole 3414, or that two or more turns of the screw 341 are provided with at least one through hole 3414. Preferably, each turn of screw 341 is provided with at least one through hole 3414. It will be appreciated that through holes 3414, if oversized or overdimensioned, may be prone to fracture of screw 341 after prolonged implantation. Accordingly, each turn of screw 341 is preferably uniformly and symmetrically distributed with 2-8 through holes 3414. The width D4 of the through hole 3414 is not more than one third of the thickness D5 of each coil of the screw 341. The length D3 of the through hole 3414 is 2 to 4 times the width D4 of the through hole 3414. In this embodiment, the screw 341 is integrally cut and formed, and may be formed by laser cutting, machining, or the like. The material is preferably nickel titanium pipe or stainless steel pipe. After the screw 341 is implanted into the target tissue for a long period of time, granulation tissue may grow into the through hole 3414, completely filling the through hole 3414. Accordingly, the screw 341 is pulled by the granulation tissue when the screw 341 is pulled in the axial direction, preventing the screw 341 from being pulled off, so that the risk of the anchor 34 falling off can be reduced.

It should be emphasized that, unlike the size and structure of the anchoring element in the prior art, the screw 341 of the anchoring element 34 provided by the present application adopts a specific anti-falling size and various anti-falling structural designs, so as to ensure that the anchoring element 34 is not easy to fall off when being implanted into the beating heart tissue for a long time.

To ensure post-implantation safety, the anchor 34 is integrally formed of a material having good biocompatibility, including but not limited to metallic materials (e.g., stainless steel) or polymeric materials (e.g., PEEK, PET). Among them, the screw seat 343 and the screw 341 are preferably made of stainless steel having high hardness. The threading structure 345 may be made of stainless steel material or polymer material (such as PEEK or PET).

In some embodiments, referring to fig. 16, the anchoring device 10 includes a drive tube 12 and a connecting rod 14 threaded into the drive tube 12. The proximal end of the pin seat 343 and the distal end of the drive tube 12 are respectively provided with S-shaped buckles in mating connection. The S-shaped buckle of the nail seat 343 and the S-shaped buckle of the driving tube 12 are buckled to form an inner cavity, and the connecting rod 14 penetrating into the driving tube 12 is inserted into the inner cavity to enable the anchoring piece 34 to be connected with the driving tube 12. The screw 341 is anchored into the target tissue by rotating the driving tube 12 to drive the screw seat 343 to rotate the screw 341. It will be appreciated that the anchor 34 can be separated from the drive tube 12 by withdrawing the connecting rod 14 from the two S-shaped snap-in butt-joint snap-in locations. The anchoring device 10 may be made of a metallic material or a polymeric material.

In some embodiments, referring to fig. 1 and 17, the delivery device 50 includes a delivery sheath 52. The anchor 10 is movably mounted through the delivery sheath 52. After the anchor 34 is detachably connected to the distal end of the anchor device 10, the anchor 34 is delivered to the target tissue through the delivery sheath 52, and the distal nozzle of the delivery sheath 52 abuts against the target tissue, so that the anchor device 10 drives the screw 341 to anchor into the target tissue.

In some embodiments, referring to fig. 18 and 19, the transcatheter annular system 1 further comprises a guide device 70. The introducer device 70 includes a first introducer sheath 71 and a second introducer sheath 72 movably disposed within the first introducer sheath 71. The second guide sheath 72 can be extended from the distal end of the first guide sheath 71 and adjusted to the vicinity of the heart tissue, thereby establishing an interventional channel from outside the body to the heart, i.e. establishing a delivery channel from outside the body to the heart tissue. At least the distal portion of the delivery sheath 52 is flexible and the delivery sheath 52 can be advanced along the delivery channel into the heart.

Preferably, both the first and second guide sheaths 71, 72 are adjustable bend sheaths, facilitating adjustment of the degree and direction of bending of the distal end portion thereof, so that the second guide sheath 72 is easily adjustable to the vicinity of the heart tissue. In other embodiments, the introducer device 70 may employ only one adjustable bend sheath as the introducer sheath. The guiding sheath tube with adjustable bending is a guiding device commonly used in interventional operations in the prior art, and is not described herein.

It should be noted that, referring to fig. 19, the delivery sheath 52 is inserted into the inner cavity of the second guiding sheath 72, and the distal end portion of the delivery sheath 52 can be bent by adjusting the bending angle of the distal end portion of the guiding device 70, so that the delivery sheath 52 can be accurately attached to the target tissue, and the implantation of the anchor 34 can be more stable and accurate.

As previously described, the plurality of anchors 34 may be sequentially anchored at circumferentially different locations of the annulus and the plurality of anchors 34 may be relatively gathered (as shown in FIG. 2) by tightening the flexible elongate member 32 in series with the plurality of anchors 34 to thereby effect contraction of the annulus.

In some embodiments, as shown in fig. 2, implant 30 further includes at least one spacer 36. The spacer 36 is movably coupled to the flexible elongate member 32. A spacer 36 is disposed between at least some of the adjacent anchors 34. It will be appreciated that the spacer 36 prevents excessive tightening of the flexible elongate member 32 which would result in too short a distance between adjacent anchors 34 to damage tissue, while the spacer 36 serves to cushion the anchor 34 and distribute the tightening force applied to the anchors 34 to ensure stable implantation of the anchors 34. Wherein the spacer 36 is a cylindrical member having a length, preferably made of a biocompatible material. The spacer 36 may be covered with a coating to reduce the risk of damage to the annulus or other heart tissue by the spacer 36.

Alternatively, a spacer 36 (as shown in FIGS. 2 and 3) may be provided between any adjacent two of the plurality of anchors 34 of the implant 30, i.e., the anchors 34 are staggered with respect to the spacer 36. Of course, it is also possible to provide a spacer 36 for each of two or more anchors 34, that is, a spacer 36 is provided between two anchors 34 that are partially adjacent, and no spacer 36 is provided between two anchors 34 that are partially adjacent, which is not limited in the present application.

In some embodiments, referring to fig. 20, the delivery device 50 further includes a delivery member 54. The distal end of the delivery member 54 is connected to the proximal end of the flexible elongate member 32. It will be appreciated that the distal end of the flexible elongate member 32 is connected to a first anchor 34. The flexible elongate member 32, the delivery member 54, and the delivery of the first anchor 34 into the patient, the proximal end of the delivery member 54 extending outside the body. In this way, the anchors 34, spacers 36, locks 38, etc. may be threaded onto the flexible elongate member 32 by delivery of the delivery member 54 so that the flexible elongate member 32 may be selected for an appropriate implantation length, thereby eliminating the need to trim the flexible elongate member 32 in vivo, avoiding the creation of particle fall-off on the wire, and providing safer procedures.

Wherein the conveying member 54 may be a wire, a filament, a rope, a strip, a belt, etc. having a certain axial length and having flexibility, and its radial cross-sectional shape may be circular, oblate, rectangular, square, or other shape, etc., which is not limited thereto by the present application. The delivery member 54 can be made of a metallic material and/or a polymeric material, preferably a biocompatible material such as stainless steel 316L, tungsten, tantalum, nitinol, polyethylene, polyamide, polypropylene, polyurethane, etc. Illustratively, the transport member 54 is an elongate wire, such as a polymer wire.

In some embodiments, the proximal end of the flexible elongate member 32 is connected to the distal end of the delivery member 54 in a U-shape, and pulling the delivery member 54 out of the body allows the delivery member 54 to be separated from the flexible elongate member 32, allowing for easy operation. In other embodiments, the delivery member 54 may be removably coupled to the flexible elongate member 32 by a threaded connection, a snap-fit connection, or the like, which will not be described in detail.

It will be appreciated that in other embodiments, the delivery device 50 may omit the delivery member 54, and the flexible elongate member 32 may be long enough so that the proximal end of the flexible elongate member 32 can extend outside the patient's body after the flexible elongate member 32 has been advanced into the heart with the first anchor. Thus, after implantation of the plurality of anchors 34, the flexible elongate member 32 is tightened to constrict the annulus. After the annulus is contracted to achieve the preferred effect of reducing regurgitation in blood, the flexible elongate member 32 may be locked by the lock 38 to maintain tension on the flexible elongate member 32, thereby maintaining the effect of contracting the annulus. The excess portion of the flexible elongate member 32 may be trimmed away by a wire cutter.

The use and operation of the transcatheter annular system 1 will be described below with reference to figures 1, 17 and 21 to 23, taking the application of the transcatheter annular system 1 to mitral valve annuloplasty as an example. Wherein, the operation route is: transfemoral vein-inferior vena cava-Right Atrium (RA) -interatrial septum (AS) -Left Atrium (LA) -Mitral Valve Annulus (MVA). The wire loop 344 of the first anchor 34 is connected to the distal end of the flexible elongate member 32 and the proximal end of the flexible elongate member 32 is connected to the delivery member 54U-shaped. The anchor 10 is threaded into the delivery sheath 52 and the first anchor 34 is preassembled with the anchor 10.

In a first step, a delivery path from the outside of the body to the mitral valve annulus is constructed using a first introducer sheath 71 and a second introducer sheath 72.

Second, first, the delivery sheath 52 is advanced distally in the delivery channel until its distal end abuts the annulus; then, operating the anchoring device 10 threaded into the delivery sheath 52 anchors the screw 341 of the first anchor 34 into the annulus of the mitral valve; next, proximally retracting delivery sheath 52 completely disengages first anchor 34 from delivery sheath 52, releasing anchor 10 from engagement with first anchor 34; finally, the anchoring device 10 and delivery sheath 52 are withdrawn.

Third, first, the spacer 36 is passed through the conveyor 54 and introduced into the conveyor tunnel; delivery sheath 52 carrying second anchor 34 is then advanced distally in the delivery channel, and spacer 36 is advanced along delivery member 54 to flexible elongate member 32 by forward advancement of delivery sheath 52, spacer 36 being interposed between first anchor 34 and second anchor 34; next, the position of the second anchor 34 is adjusted according to the size of the annulus, and the second anchor 34 is implanted. The distance between the second anchor 34 and the first anchor 34 needs to be greater than the axial length of the spacer 36.

Fourth, the third step is repeated, sequentially implanting the anchors 34 and the spacers 36 sequentially from the anterior trigone of the mitral valve to the posterior trigone or vice versa, so that the anchors 34 and the spacers 36 are evenly distributed over the annulus (as shown in fig. 2), and after a sufficient number of anchors 34 have been implanted, the anchor device 10 and delivery sheath 52 are withdrawn.

Fifth, first, the proximal end of the transport member 54 is passed through the lock 38, and the lock 38 is fed along the transport member 54 to the flexible elongate member 32; the control lockout 38 then adjusts the length of the flexible elongate member 32 over the annulus to reduce the spacing between the plurality of anchors 34, thereby causing the annulus to contract. After good crimping results are achieved, the lock 38 locks the length of the flexible elongate member 32 to maintain tension in the flexible elongate member 32. It should be noted that the delivery member 54 can be withdrawn after the flexible elongate member 32 is stably coupled to the lock 38.

It should be noted that during the implantation of the anchor 34, there is a low probability of a crimping event, at which time the DSA and ultrasonic devices may be combined, the drive tube 12 of the anchor 10 may be rotated in opposite directions, the anchor 34 may be unscrewed, the flexible elongate member 32 may be removed, and the anchor 34 may be re-screwed for implantation.

It will be appreciated that the transcatheter annular system 1 provided by the present application may also be applied to annuloplasty of the tricuspid valve, and will not be described in detail.

It should be noted that, without conflict, the embodiments of the present application and features of the embodiments may be combined with each other, and any combination of features of different embodiments is also within the scope of the present application, that is, the above-described embodiments may be further combined according to actual needs.

It should be noted that all the foregoing drawings are exemplary illustrations of the present application, and do not represent actual sizes of products. And the dimensional relationships among the components in the drawings are not intended to limit the actual products of the application.

The foregoing is a description of embodiments of the present application, and it should be noted that, for those skilled in the art, modifications and variations can be made without departing from the principles of the embodiments of the present application, and such modifications and variations are also considered to be within the scope of the present application.

Claims

1. An anti-drop anchor comprising a screw configured to anchor into a target tissue and a seat attached to a proximal end of the screw, the screw extending helically from the seat distally, the screw having an axial length in the range of 4mm to 5.4mm and a radial width in the range of 2.6mm to 4mm.

2. The anti-drop anchor of claim 1, wherein the number of turns of the screw comprises at least three turns, and wherein the pitch of the screw comprises a first pitch and a second pitch, the first pitch being less than the second pitch.

3. The drop-resistant anchor of claim 1, further comprising an anchor hook disposed on the screw, wherein the anchor hook is disposed at an angle in the range of 30 ° to 60 ° to the screw.

4. A drop-resistant anchor as claimed in claim 3, wherein at least one turn of the screw is provided with 2-6 of the flukes, the surface of the flukes being roughened.

5. The anti-drop anchor of claim 1, wherein the cross-section of the turns of the screw is elliptical, and the ratio of the major axis dimension to the minor axis dimension of the ellipse ranges from 2 to 3.

6. The anti-drop anchor of claim 1, wherein at least one coil of the screw is provided with at least one through hole.

7. The drop-resistant anchor of claim 6, wherein the through-hole has a width no greater than one third of the thickness of each turn of the screw.

8. The anti-drop anchor of claim 1, wherein the screw comprises a bend, a screw, and a distal tip in order from the proximal end to the distal end, the bend comprising a plurality of arcuate segments connected in order in a smooth manner, the bend being circular in projection from the proximal end to the distal end.

9. The anti-drop anchor of claim 1, further comprising a threading structure movably sleeved on the nail seat, the threading structure having a threading aperture configured for passage of a flexible elongate member.

10. An implant, the implant comprising:

a plurality of the fall off prevention anchors of any one of claims 1 to 9;

a flexible elongate member connecting a plurality of the anchors, the flexible elongate member configured to adjust a spacing between the plurality of anchors; and

a lock connected to the flexible elongate member, the lock configured to lock a length of the flexible elongate member to maintain tension of the flexible elongate member.

11. The implant of claim 10, further comprising at least one spacer movably coupled to the flexible elongate member, the spacer being disposed between at least a portion of adjacent ones of the anchors.

12. A transcatheter crimping system comprising an anchor device having a distal end detachably connected to the anchor seat, a delivery device configured to deliver the anchor to the target tissue, and the implant of claim 10 or 11, the anchor device configured to drive the helical screw to anchor into the target tissue.