CN113274167A - Edge-to-edge repair device and edge-to-edge repair system - Google Patents

Abstract

The invention provides an edge-to-edge repair device, which comprises a puncture part and a fixing part, wherein the puncture part is implanted on a valve leaflet on one side, the fixing part is implanted on a valve leaflet on the other side, the puncture part comprises at least one puncture part for puncturing the valve leaflet, the puncture part sequentially punctures the valve leaflet on one side and the valve leaflet on the other side and then is combined with the fixing part, so that the valve leaflets on the two sides are at least partially connected with the fixing part through the puncture part. The invention also relates to an edge-to-edge repair system. The edge-to-edge repair device and the system can safely, effectively and quickly realize the edge-to-edge repair of the mitral valve.

Description

Edge-to-edge repair device and edge-to-edge repair system

Technical Field

The invention relates to the technical field of valve intervention repair, in particular to an edge-to-edge repair device and an edge-to-edge repair system.

Background

The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, and a normal healthy mitral valve can control the flow of blood from the left atrium to the left ventricle while avoiding the flow of blood from the left ventricle to the left atrium. The mitral valve includes a pair of leaflets, called the anterior leaflet and the posterior leaflet. Under normal conditions, when the left ventricle of the heart contracts, the edges of the anterior leaflet and the posterior leaflet are completely involuted to avoid blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or their associated structures undergo an organic or functional change, the anterior and posterior leaflets of the mitral valve coapt poorly, and when the left ventricle of the heart contracts, blood flows back from the left ventricle to the left atrium, known as "mitral regurgitation".

The edge-to-edge repair of the mitral valve is a common method for treating mitral regurgitation, and particularly, the edges of the anterior leaflet and the posterior leaflet of the mitral valve which cannot be normally combined are fixed together by means of suturing or clamping and the like to form a diploporous structure, so that the gap between the leaflets is reduced, and the regurgitation is eliminated or reduced. The traditional bicuspid edge-to-edge repair is operated under the condition of direct vision with an opening, and needs to open a chest and establish extracorporeal circulation of blood, so the risk is high.

With the progress of the technology, various interventional instruments and minimally invasive surgeries for treating mitral regurgitation have been developed, and the prior art US20160113762a1 discloses an edge-to-edge repair device, wherein a magnetic sheet is respectively implanted in an anterior leaflet and a posterior leaflet in a suturing mode, and the leaflets on the two sides are mutually attracted and closed through the magnetic sheets so as to complete edge-to-edge repair; however, the edge-to-edge repair device needs to be implanted by opening the heart under the conditions of thoracotomy and cardiac arrest, and the mode causes great harm to patients; and the magnetic sheet is easily interfered by external magnetic metal and magnetic field, thereby causing damage to patients. The prior art US6269819B2 discloses an edge-to-edge repairing device, which comprises a straight piece with double puncture needles, a front leaf and a rear leaf of the straight piece are sequentially punctured, the straight piece is bent, and a round hole at the bottom end is matched and locked with the puncture needles, so that edge-to-edge repairing is completed; however, the edge-to-edge repair device is difficult to catch the anterior leaflet and the posterior leaflet, and under the condition that the leaflets are not fixed, the leaflets are punctured, so that the valve is easy to tear; and the straight piece needs to be matched with the puncture needle after being bent in the ventricle, so that the straight piece is difficult to realize.

Disclosure of Invention

The technical problem to be solved by the present invention is to provide a safer, more effective and faster edge-to-edge repairing device and system, aiming at the defects of the prior art.

In order to solve the technical problem, the invention provides an edge-to-edge repair device, which comprises a puncture part and a fixing part, wherein the puncture part is used for being implanted on a valve leaflet on one side, the fixing part is used for being implanted on a valve leaflet on the other side, the puncture part comprises at least one puncture part used for puncturing the valve leaflet, the puncture part sequentially punctures the valve leaflet on the one side and the valve leaflet on the other side and then is combined with the fixing part, so that the valve leaflets on the two sides are at least partially connected with the fixing part through the puncture part.

The invention also provides an edge-to-edge repairing system which comprises an edge-to-edge repairing device and a conveying device, wherein the conveying device comprises a push rod and a clamping assembly, the near end of the clamping assembly is connected to the push rod, the clamping assembly comprises two clamping arms capable of being opened and closed relatively, a puncturing part and a fixing part of the edge-to-edge repairing device are respectively preassembled on the two clamping arms, and the push rod moves towards the near end along the axial direction to drive the two clamping arms to be mutually closed, so that a puncturing part of the puncturing part punctures valve leaflets and then is combined with the fixing part.

The puncture piece and the fixing piece of the edge-to-edge repair device are respectively preassembled on the two clamping arms of the conveying device, the push rod moves towards the near end along the axial direction to drive the two clamping arms to be mutually closed, so that the puncture part on one clamping arm sequentially punctures the valve leaflets on one side and the valve leaflets on the other side and then is combined with the fixing piece on the other clamping arm, the valve leaflets on the two sides are connected in an edge-to-edge mode at the combination position between the puncture piece and the fixing piece, and the edge-to-edge repair system is simple in operation and convenient to use and can safely, effectively and quickly complete edge-to-edge repair of the mitral valve.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly described below.

Fig. 1 is a schematic structural diagram of an edge-to-edge repair system according to an embodiment of the present invention.

FIG. 2 is an exploded view of the edge-to-edge repair device of the edge-to-edge repair system of FIG. 1.

Fig. 3 is a perspective view of the edge-to-edge repair device of fig. 2.

Fig. 4 is a side view of the piercing member of fig. 3.

Fig. 5 is a side view of the fixing member of fig. 3.

Fig. 6 is a schematic view of the puncturing element of fig. 3 in combination with a securing element.

Fig. 7 is a cross-sectional view of the edge-to-edge repair device of fig. 6.

Fig. 8 is an enlarged view of the stabilizing assembly of fig. 2.

Fig. 9 is an enlarged view of the positioning member and positioning arm of the stabilizing assembly of fig. 8.

Fig. 10 is a perspective view of a clamping assembly of the delivery device of fig. 2.

Fig. 11 is a perspective view of a first clamp arm of the clamp assembly of fig. 10.

Fig. 12 is a cross-sectional view of the first gripper arm of fig. 11.

Fig. 13 is a perspective view of a second clamp arm of the clamp assembly of fig. 10.

Fig. 14 is a cross-sectional view of the second gripper arm of fig. 13.

FIG. 15 is a perspective view of a pusher member of the clamping assembly of FIG. 10.

FIG. 16 is a perspective view of the retaining sleeve of the clamping assembly of FIG. 10.

Fig. 17 is a schematic view of one of the states of the clamping assembly of fig. 10.

Fig. 18-24 are schematic views of the use process of the edge-to-edge repair system provided by the present invention.

Fig. 25 is an exploded perspective view of another embodiment of the edge-to-edge repair device of the present invention.

FIG. 26 is a schematic view of the combined edge-to-edge repair device of FIG. 25.

Fig. 27 is a cross-sectional view of the edge-to-edge repair device of fig. 26.

Detailed Description

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

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, 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 invention 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 invention.

To more clearly describe the structure of the transcatheter suture implantation device and the transcatheter chordae tendineae implantation system, the terms "proximal" and "distal" are used herein as terms customary in the field of interventional medicine. 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. 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 invention 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 invention.

Referring to fig. 1 to 3, the present invention provides an edge-to-edge repair system 100, which includes an edge-to-edge repair device 20 and a delivery device 40, wherein the edge-to-edge repair device 20 includes a piercing element 22 for implanting on one side of a valve leaflet and a fixing element 24 for implanting on the other side of the valve leaflet, the piercing element 22 includes at least one piercing portion 220 for piercing the valve leaflet, and the piercing portion 220 is combined with the fixing element 24 after piercing the valve leaflet on the one side and the valve leaflet on the other side in sequence, so that the valve leaflets on the two sides are connected with the fixing element 24 at least partially through the piercing element 22. The conveying device 40 comprises a pushing assembly 50 and a clamping assembly 70, the pushing assembly 50 comprises a push rod 52, the proximal end of the clamping assembly 70 is connected to the push rod 52, and the clamping assembly 70 comprises two clamping arms which can be opened and closed relatively; the puncture element 22 and the fixing element 24 of the edge-to-edge repair device 20 are pre-mounted on the two holding arms, respectively, and the push rod 52 moves axially and proximally to drive the two holding arms to close each other, so that the puncture portion 220 of the puncture element 22 punctures the valve leaflet and then is combined with the fixing element 24.

The puncture element 22 and the fixing element 24 of the edge-to-edge repair device 20 provided by the invention are respectively pre-installed on two clamping arms of the conveying device 40, the push rod 52 moves towards the near end along the axial direction to drive the two clamping arms to be mutually closed, so that the puncture part 220 on one clamping arm sequentially punctures the valve leaflet on one side and the valve leaflet on the other side and then is combined with the fixing element 24 on the other clamping arm, so that the valve leaflets on the two sides are at least partially connected with the fixing element 24 through the puncture element 22, thereby realizing the repair of the valve leaflets in an edge-to-edge manner, and the edge-to-edge repair system 100 is simple in operation and convenient to use and can safely, effectively and quickly finish the edge-to-edge repair.

Referring to fig. 3 to 5, the puncturing element 22 further includes a puncturing base 222, and the puncturing portion 220 is disposed on a side of the puncturing base 222 facing the fixing element 24; the holder 24 includes a holder 241 and a receiving portion 243 provided on a side of the holder 241 facing the puncture element 22, and the puncture portion 220 is connected to the receiving portion 243 after puncturing the leaflet. Specifically, the puncturing part 220 is at least one puncturing needle fixedly connected to the puncturing base 222, and the accommodating part 243 is an accommodating sleeve fixedly connected to the fixing base 241 corresponding to the puncturing needle, and the puncturing needle can be fixedly inserted into the accommodating sleeve. The number of the puncture needles 22 and the accommodating portions 243 may be two, three, or several, as necessary, and the number of the accommodating portions 243 corresponds to the number of the puncture needles 22. In this embodiment, the puncture base 222 is provided with two puncture parts 220 (two puncture needles) spaced in parallel, and the fixing base 241 is provided with receiving parts 243 (two receiving sleeves) corresponding to the two puncture parts 220; the two puncture parts 220 are fixedly connected with the two containing parts 243 after penetrating through the valve leaflets, so that the puncture difficulty is reduced, the connection strength between the puncture piece 22 and the fixing piece 24 is improved, stress points can be dispersed, and the valve leaflets are prevented from being torn.

As shown in fig. 4 to 7, the puncturing part 220 and the receiving part 243 are connected by interference fit, key, snap, or screw. Specifically, the puncturing part 220 includes an extension rod 223 fixedly connected to the puncturing base 222 and a needle 226 disposed at an end of the extension rod 223 far away from the puncturing base 222, the accommodating part 243 is provided with an accommodating cavity 245, and the needle 226 is inserted into the accommodating cavity 245, so that the puncturing part 220 and the accommodating cavity 245 are in interference fit, key connection, elastic deformation connection, latch connection, buckle connection or threaded connection. In this embodiment, the needle 226 at the distal end of the puncturing portion 220 is tapered, and the receiving cavity 245 is shaped to match the shape of the distal end of the puncturing portion 220, and is generally tapered or cylindrical. The general receiving portion 243 has a cylindrical shape as a whole, and may have a cross-sectional shape parallel to the radial direction of a circle, an ellipse, a polygon, or other various shapes, and a circle and an ellipse are generally preferable.

In other embodiments, the radial dimension of the proximal end of the needle 226 and/or the extension rod 223 is slightly larger than the radial dimension of the accommodating cavity 245 of the accommodating portion 243, and when the needle 226 is inserted into the accommodating cavity 245, the needle 226 and the accommodating portion 243 are tightly fitted and plugged, so that the two form a fixed connection with an interference fit.

In other embodiments, the piercing portion 220 and the receiving portion 243 may be snap-fit, i.e., a portion or a complete circumferential cut is made at the proximal end of the needle 226 to form a tooth or flange; the sidewall of the accommodating cavity 245 of the accommodating portion 243 is provided with a groove or a hole corresponding to the convex tooth or the flange, and after the puncturing portion 220 completes puncturing, the needle 226 is inserted into the accommodating cavity 245, so that the convex tooth or the flange of the needle 226 is clamped into the groove or the hole of the accommodating portion 243, and the fixed connection between the two is realized. Preferably, the teeth or flanges of the needle 226 and/or the grooves or holes of the receiving portion 243 have a certain elasticity, and the two are elastically deformed when they are clamped together, so as to ensure smooth connection and prevent disengagement.

In other embodiments, an external thread is disposed on the outer surface of the puncturing part 220, and an internal thread corresponding to the external thread of the puncturing part 220 is disposed on the inner wall of the receiving cavity 245 of the receiving part 243, and the external thread is screwed with the internal thread.

In other embodiments, the puncturing portion 220 and the receiving portion 243 may be connected by a key or a snap connection.

Preferably, the puncturing part 220 and the puncturing base 222, and the fixing base 241 and the receiving part 243 are each formed by processing a metal material such as stainless steel or nickel titanium, and the puncturing part 220 and the puncturing base 222, and the fixing base 241 and the receiving part 243 may be integrally formed, or may be fixedly connected by welding, bonding, riveting, screwing, or the like after being separately formed.

Preferably, in order to increase the friction between the puncture base 222 and the fixation base 241 and the corresponding valve leaflets, increase the biocompatibility of the puncture base 222 and the fixation base 241, and avoid the valve leaflets from being torn, a first anti-skid gasket 225 is disposed on the side of the puncture base 222 facing the valve leaflets, and/or a second anti-skid gasket 245 is disposed on the side of the fixation base 24 facing the valve leaflets, and the first anti-skid gasket 225 and the second anti-skid gasket 245 are made of biocompatible polymer materials with high friction coefficients. Specifically, the first and second non-slip pads 225 and 245 may be selected from at least one of an elastic pad, a heart patch, a felt pad, a mesh structure, a disk structure, or a double disk structure; preferably a polyester fabric gasket. The first anti-slip gasket 225 may be fixedly attached to the puncture base 222 by means of bonding, stitching, or the like; if at least one through hole is arranged on the puncture base 222, the suture thread which is arranged on the first anti-skid pad 225 is sewed on the puncture base 222 through the through hole; the second anti-skid pad 245 can also be fixedly connected with the fixed base 241 by means of bonding, sewing and the like; if at least one through hole is formed on the fixing base 241, the suture thread passing through the second anti-slip pad 245 is sewed on the fixing base 241 through the through hole.

A through hole 2250 is formed in the first anti-skid pad 225 corresponding to the puncturing part 220, and one end of the puncturing part 220, which is far away from the puncturing base 222, passes through the corresponding through hole 2250 and then is exposed out of the first anti-skid pad 225; a through hole 2450 is formed in the second anti-slip gasket 245 corresponding to the receiving portion 243, and one end of the receiving portion 243 far away from the fixing base 241 is inserted into the corresponding through hole 2450.

Preferably, as shown in fig. 21, the needle 226 of the puncture element 22 is provided with a puncture needle protection cover 227, and the protection cover 227 is used for preventing the puncture element 22 and the fixing element 24 from being mistakenly connected during the process of delivering the puncture part 220 and preventing the edge-to-edge repair device 20 from mistakenly injuring the valve leaf in the open state.

Referring to fig. 1-2 and 8-9, the edge-to-edge repair system 100 further includes a stabilizing assembly 60, the stabilizing assembly 60 includes an outer sheath 62 sleeved outside the push rod 52, a positioning member 64 disposed at a distal end of the outer sheath 62, and a positioning arm 66 movably inserted in the outer sheath 62. The positioning member 64 is used for supporting the valve leaflets, the distal ends of the positioning arms 66 extend out of the outer sheath 62, the positioning member 64 is arranged at the distal ends of the positioning arms 66, the positioning member 64 extends out of the outer sheath 62 along with the axial movement of the positioning arms 66 and extends obliquely towards the axial line far away from the outer sheath 62, and the included angle between the axial direction of the positioning member 64 and the axial direction of the positioning arms 66 ranges from 120 degrees to 150 degrees so as to adapt to the anatomical structure of the valve leaflets and provide supporting force at the same time. In this embodiment, the number of the positioning arms 66 is two, the two positioning arms 66 are oppositely disposed at intervals, and the distal end of each positioning arm 66 is provided with at least one positioning member 64.

The outer sheath 62 may be a single or multi-layer composite tube, and preferably, the outer sheath 62 is made of an inner PTFE inner film, a middle metal braided reinforcement layer, and an outer Pebax material, and has a hollow inner lumen.

The positioning member 64 may also be a rod-like structure formed by at least one support rod with a smooth outer surface to avoid damaging the leaflets. The positioning member 64 is made of a resilient and/or flexible material to accommodate the anatomy of the leaflets and the range of motion of the leaflets, and can be selected from a metallic material, a polymeric material, or a metal-polymer composite material to effectively avoid damage to the leaflets. Preferably, the positioning member 64 is made of a material with a shape memory function.

The positioning arm 66 is a support rod with an axial length, and the support rod may be a solid or hollow structure with a single-layer or multi-layer composite structure, and may also be formed by winding a single wire or a plurality of wires. The cross section of the supporting rod can be regular circle or ellipse, crescent, semicircle, polygon and the like, and is preferably circle. The positioning arm 66 is preferably of a stiffness or rigidity to provide support to facilitate pushing of the positioning member 64.

The retainer 64 and the retainer arm 66 may be of unitary construction or fixedly connected together by non-removable or removable attachment. That is, the positioning arm 66 and the positioning member 64 may be respectively machined and then fixedly connected together by welding, bonding, sleeving, screwing, interference fit, etc.

The width of the positioning member 64 parallel to the radial direction is greater than the radial dimension of the positioning arms 66, so that the positioning member 64 has a larger bearing area and is beneficial to bearing the valve leaflets. The width direction of the positioning member 64 is the same as the width direction of the holding arm.

The positioning member 64 may be a plate-shaped structure with or without elasticity, so that the positioning member 64 has a larger contact area with the valve leaflets, so as to better fit the valve leaflets and improve the supporting force for the valve leaflets. The positioning member 64 may also be an annular closed elastic ring, wherein the elastic ring may be a closed structure with a circular shape, a rhombic shape, an oval shape, a pear shape, a polygonal shape or other irregular shapes; preferably, at least one supporting bar may be disposed in the elastic ring to improve stability of the elastic ring. The positioning member 64 of the stabilizing assembly 60 includes a plurality of limbs that stretch open to better conform to the valve leaflets. The positioning member 64 may also be a mesh structure woven from elastic metal wires or polymer wires.

Preferably, each of the positioning members 64 is a deformable mesh cage, and in particular, the positioning members 64 are cage-like structures formed by weaving wires having certain elasticity and tension. When the cage-like structure is received in the sheath tube 62, the positioning member 64 is pressed and deformed to be in a compressed state; when the positioning element 64 extends out of the sheath, the cage-like structure is expanded, and the volume of the expanded positioning element 64 is larger than that of the positioning element when the positioning element is extruded, so that more stable support is provided for the valve leaflets. In the present application, the thread forming the cage structure may be an elastic metal thread or a polymer thread having a shape memory function. In this embodiment, the positioning member 64 is made of a nickel titanium wire having superelasticity.

The positioning member 64 in this embodiment has a cylindrical middle portion, and both the proximal and distal portions are tapered, and the taper angles of the tapers at both ends are the same. It is understood that the middle portion of the positioning member 64 may have any other shape. For example, the positioning member 64 may have a spindle-shaped structure with the same taper angle at both ends, or may have a structure with different taper angles at both ends.

Preferably, the positioning member 64 is at least partially made of a non-X-ray transmissive material selected from stainless steel or a nickel titanium alloy. Therefore, before the clamping assembly 70 clamps the valve leaflets, after the positioning element 64 is in contact with the valve leaflets, the flexible or elastic positioning element 64 can swing correspondingly along with the movement range of the valve leaflets, and an operator can judge the relative position between the edge-to-edge repair device 20 and the valve leaflets through X-rays, so that the clamping assembly 70 can be operated more quickly and accurately to clamp the valve leaflets, the operation time is shortened, and the operation success rate is improved. In this embodiment, the positioning element 64 is a metal ball of a three-dimensional mesh cage structure formed by weaving nickel-titanium metal wires, which not only can provide more stable support for the valve leaflets supported on the positioning arms 66, but also has more three-dimensional developing effect.

Referring to fig. 2 and 10, the two holding arms of the holding assembly 70 include a first holding arm 72 and a second holding arm 74 hinged to each other near the proximal ends, and the distal end of the first holding arm 72 and the distal end of the second holding arm 74 can be opened and closed relatively. The clamp assembly 70 further includes a push member 75 and a retaining sleeve 77 for actuating the relative opening and closing of the first and second clamp arms 72, 74. By controlling the opening and closing of the first and second clamp arms 72, 74, the puncturing element 22 of the edge-to-edge repair device 20 can be caused to puncture the leaflets and be fixedly attached to the anchors 24, and the edge-to-edge repair device 20 can be released over the leaflets. Specifically, the pusher 75 is moved axially distally to bring the distal ends of the first and second gripper arms 72, 74 away from each other; the pusher 75 is moved axially proximally to bring the distal ends of the first and second gripper arms 72, 74 toward one another to engage the lancet 22 with the anchor 24.

As shown in fig. 11, the first clamping arm 72 includes a hinge portion 721, a connecting plate 723 disposed at a proximal end of the hinge portion 721, and a clamping portion 725 disposed at a distal end of the hinge portion 721; the middle part of the hinge part 721 is provided with a hinge hole 7210 along the radial direction of the fixing sleeve 77, and the connecting plate 723 is provided with a sliding groove 7230 inclined to the axial direction. When the first gripper arm 72 is mounted in the set collar 77, the hinge hole 7210 is parallel to the radial direction of the set collar 77, the distal end of the slide groove 7230 is close to the axial line of the set collar 77, and the proximal end of the slide groove 7230 is far from the axial line of the set collar 77. The distal end of the clamping portion 725 opens into a positioning groove 7250 on the side facing the second clamping arm 74, the positioning groove 7250 having a shape corresponding to the outer shape of the lancet 22 or the holder 24, i.e., the positioning groove 7250 is used for pre-loading the lancet 22 or the holder 24. Preferably, the distal end of the first holding arm 72 is provided with spaced through holes 7252, each through hole 7252 is communicated with the positioning groove 7250, the puncturing element 22 or the fixing element 24 is provided with a threading hole, and after the puncturing element 22 or the fixing element 24 is pre-installed in the positioning groove 7250, a suture or a nickel titanium steel wire with a diameter of 0.2mm is threaded in the threading hole of the puncturing element 22 or the fixing element 24 and the through hole 7252 of the first holding arm 72, and the proximal end of the suture or the nickel titanium steel wire extends out from the proximal end of the first holding arm 72.

In other embodiments, the positioning groove 7250 at the distal end of the first holding arm 72 may be omitted, the distal end of the side of the first holding arm 72 facing the second holding arm 74 may be directly provided with spaced through holes 7252, the puncturing element 22 or the fixing element 24 may be provided with threading holes corresponding to the through holes 7252, the threading holes of the puncturing element 22 or the fixing element 24 and the corresponding through holes 7252 may be threaded with sutures or nitinol wires, and the proximal ends of the sutures or nitinol wires may extend from the proximal end of the first holding arm 72.

As shown in fig. 13 and 14, the second holding arm 74 has a structure similar to that of the first holding arm 72, and specifically, the second holding arm 74 includes a hinge portion 741, a connecting plate 743 disposed at a proximal end of the hinge portion 741, and a holding portion 745 disposed at a distal end of the hinge portion 741; the middle of the hinge 741 is opened with a hinge hole 7410 along the radial direction of the fixing sleeve 77, and the connecting plate 743 is provided with a sliding slot 7430 inclined to the axial direction. When the first and second clamp arms 72 and 74 are mounted together in the fixing sleeve 77, the hinge hole 7210 of the first clamp arm 72 corresponds to the hinge hole 7410 of the second clamp arm 74, the distal end of the slide groove 7430 of the second clamp arm 74 is close to the axial line of the fixing sleeve 77, the proximal end of the slide groove 7430 is far from the axial line of the fixing sleeve 77, and the slide grooves 7230 of the first clamp arm 72 and the slide grooves 7430 of the second clamp arm 74 are partially overlapped in a staggered manner. The distal end of the retaining portion 745 opens into a positioning slot 7450 facing the side of the first retaining arm 72, the positioning slot 7450 having a shape corresponding to the outer shape of the piercing member 22 or the fixing member 24, i.e., the positioning slot 7450 is used to pre-load the piercing member 22 or the fixing member 24. Preferably, the distal end of the second holding arm 74 is provided with spaced through holes 7452, each through hole 7452 is communicated with the positioning groove 7450, the puncturing element 22 or the fixing element 24 is provided with a threading hole, and after the puncturing element 22 or the fixing element 24 is pre-installed in the positioning groove 7450, the suture or the nickel-titanium wire is threaded through the threading hole of the puncturing element 22 or the fixing element 24 and the through hole 7452 of the second holding arm 74, and the proximal end of the suture or the nickel-titanium wire extends out of the proximal end of the second holding arm 74.

In other embodiments, the positioning slot 7450 at the distal end of the second holding arm 74 may be omitted, the distal end of the side of the second holding arm 74 facing the first holding arm 72 may be directly provided with spaced through holes 7452, the puncturing element 22 or the fixing element 24 may be provided with threading holes corresponding to the through holes 7452, the threading holes of the puncturing element 22 or the fixing element 24 and the corresponding through holes 7452 are threaded with sutures or nitinol wires, and the proximal ends of the sutures or nitinol wires extend from the proximal end of the second holding arm 74.

As shown in fig. 15, the pushing member 75 includes a hollow cylindrical tube 752 at the proximal end and a connecting piece 754 of a flat structure at the distal end, and the shape of the hollow cylindrical tube 752 is adapted to the shape of the inner cavity of the retaining sleeve 77 so that the pushing member 75 can be clearance-fitted and axially slide in the inner cavity of the retaining sleeve 77. The interior of the hollow cylindrical tube 752 is adapted to fixedly attach to the distal end of the drive rod 522 of the push rod 52. The connecting piece 754 is used for adapting the connecting plate 723 of the first clamping arm 72 and the connecting plate 743 of the second clamping arm 74 so as to reduce the outer diameter of the assembly of the first clamping arm 72, the second clamping arm 74 and the pushing piece 75 after assembly. Two protruding driving pins 7540 are radially provided on opposite sides of the distal end of the connecting plate 723, and the two driving pins 7540 are used to connect the sliding grooves 7230 of the first and second clamp arms 72 and 7430 of the second clamp arm 74, respectively.

As shown in fig. 16, the retaining sleeve 77 includes a connecting ring 772 and two branches 774 axially disposed at opposite intervals at the distal end of the connecting ring 772, and the retaining sleeve 77 is sleeved outside the pushing member 75; specifically, the pusher member 75 is movably received in the inner cavity of the retaining sleeve 77. The two branches 774 define a receiving groove 775 therebetween, and the receiving groove 775 is used for receiving the pushing member 75, the proximal ends of the first clamping arm 72 and the second clamping arm 74. A through hole 7740 is radially formed in each of the two branches 744, and the through hole 7740 is used to connect the first clamping arm 72 and the second clamping arm 74 via the connecting shaft 78.

The edge-to-edge repairing system 100 further comprises a control handle 54 disposed at the proximal end of the push rod 52, the push rod 52 comprises a push tube 520 and a driving rod 522 movably inserted in the push tube 520, and the proximal ends of the push tube 520 and the driving rod 522 are connected to the clamping assembly 70; the handle 54 is used to transport the edge-to-edge repair device 20 and drives the two clamp arms of the clamp assembly 70 to open or close each other by driving the driving rod 522 to move axially relative to the push tube 520.

Referring to fig. 10 to 17, when the clamping assembly 70 is assembled, the connecting plate 723 of the first clamping arm 72 and the connecting plate 743 of the second clamping arm 74 are used to clamp the connecting plate 754 of the pushing member 75, so that the positioning groove 7250 of the first clamping arm 72 faces the positioning groove 7450 of the second clamping arm 74, the hinge hole 7210 of the first clamping arm 72 faces the hinge hole 7410 of the second clamping arm 74, and the two driving pins 7540 of the pushing member 75 are inserted into the positioning groove 7250 of the first clamping arm 72 and the positioning groove 7450 of the second clamping arm 74, respectively; inserting the proximal end of the pushing member 75 into the inner cavity of the retaining sleeve 77 from the distal end of the retaining sleeve 77 until the hinge holes 7210 and 7410 of the first and second clamping arms 72 and 74 face the corresponding through holes 7740; the coupling shaft 78 is inserted into the through hole 7740 of the fixing sleeve 77, the hinge hole 7210 of the first holding arm 72, and the hinge hole 7410 of the second holding arm 74, so that the first holding arm 72 and the second holding arm 74 can swing about the coupling shaft 78. The proximal end of the retaining sleeve 77 is fixedly connected to the distal end of the push tube 520, the proximal end of the pusher member 75 is connected to a drive rod 522 (shown in fig. 2) having a length, and the proximal end of the drive rod 522 extends outside the patient and is connected to the manipulation handle 54, such that the drive rod 522 can be moved axially relative to the push tube 520 to advance the pusher member 75 distally or retract it proximally, causing the drive pin 7540 to slide within the corresponding slide groove 7230, 7430 to cause relative rotation between the first and second grasping arms 72, 74, i.e., the distal end of the first grasping arm 72 and the distal end of the second grasping arm 74 open and close with respect to each other, thereby effecting opening or closing of the grasping assembly 70 to grasp or release the valve leaflet.

As shown in fig. 17, in the present embodiment, the expandable angle between the first and second gripping arms 72 and 74 is in the range of 0 to 90 ° to facilitate the catching of the leaflet. The first holding arm 72 and the second holding arm 74 are each a sheet, a plate, a petal, or an arc surface having a certain width, and are not particularly limited. The opposing surfaces of the first and second gripping arms 72, 74 are gripping surfaces that contact the leaflets and on which friction enhancing elements may be provided, e.g., raised teeth, waves, bumps, friction pads, barbs, etc.

Referring to fig. 18-24, the following description will be directed to the use of the edge-to-edge repair system 100 of the present invention in connection with the mitral valve repair procedure.

First, before use, the edge-to-edge repairing device 20 is pre-assembled in the holder assembly 70, i.e., the piercing member 22 and the fixing member 24 are pre-assembled in the positioning groove 7250 of the first holder arm 72 and the positioning groove 7450 of the second holder arm 74, respectively; puncture from the apex location and deliver a guidewire (not shown) to the mitral valve orifice; as shown in fig. 18, the sheath 62 is delivered over the guide wire by a guiding device (not shown) such as an adjustable bending catheter to below the valve margin, the stabilizing assembly 60 is released (as shown in fig. 19), and the free ends of the anterior leaflet 401 and the posterior leaflet 403 are confined between two positioning members 64, thereby restricting the movement of the leaflets to slow the pulsation of the leaflets; at this point, the two positioning members 64 of the stabilizing assembly 60 may exhibit significant rocking under ultrasound to demonstrate that the leaflets are confined.

Secondly, as shown in fig. 20, the sheath tube 62 is fixed, the push tube 520 is conveyed through the inner cavity of the sheath tube 62, and after reaching the position below the valve leaf edge, the driving rod 522 is pushed to the far end to open the first clamping arm 72 and the second clamping arm 74, and then the clamping assembly 70 is slowly pushed to the far end;

third, as shown in fig. 21, after the first and second grasping arms 72 and 74 reach under the leaflet, the driving rod 522 is moved proximally to close the first and second grasping arms 72 and 74, and the anterior and posterior leaflets 401 and 403 abut against the puncture element 22 and the fixing element 24, respectively; at this time, if the swing of the two positioning members 64 is found to be weaker than before, it indicates that the front leaf 401 and the rear leaf 403 are effectively clamped; if the anterior leaflet 401 and the posterior leaflet 403 are not grasped, the first grasping arm 72 and the second grasping arm 74 are retracted proximally of the leaflet, the grasping assembly 70 is again advanced and the drive rod 522 is moved proximally to re-close the first grasping arm 72 and the second grasping arm 74 until the first grasping arm 72 and the second grasping arm 74 grasp the leaflet.

Fourthly, as shown in fig. 22 and 23, the puncture needle protective sleeve 227 is pulled and withdrawn by the steel wire, and then the first clamping arm 72 and the second clamping arm 74 are closed, so that the puncture needle 22 is matched with the fixing piece 24; as shown in fig. 24, the nitinol wires threaded through the through holes 7252 and 7452 of the first and second clamping arms 72 and 74 are withdrawn to release the edge-to-edge repair device 20, and then the clamping and stabilizing assemblies 70 and 60 are sequentially withdrawn to complete the edge-to-edge repair of the mitral valve.

Fig. 25 and 27 illustrate another embodiment of an edge-to-edge device 20a of the present invention, the edge-to-edge device 20a being similar to the edge-to-edge device 20 except that: only one puncture part 220 is arranged in the middle of the side surface of the puncture piece 22a facing the fixing piece 24a of the edge-to-edge recovery device 20a, one accommodating part 243 corresponding to the puncture part 220 is arranged on the side surface of the fixing piece 24 facing the puncture piece 22a, the first anti-skid gasket 225a is provided with one through hole corresponding to the puncture part 220, and the second anti-skid gasket 245a is provided with a through hole corresponding to the accommodating part 243. The piercing part 220 of the piercing member 22a passes through the through hole of the first anti-slip gasket 225a to expose the first anti-slip gasket 225 a; the receiving portion 243 of the fastener 24a is inserted into the second anti-slip pad 245 a. When the puncturing element 22a is engaged with the fixing element 24a, the puncturing part 220 of the puncturing element 22a punctures the valve leaflet and then is combined with the fixing element 24a, and the edge-to-edge connection can be effectively and quickly completed.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims (20)

1. An edge-to-edge repair device, which is characterized by comprising a puncture component and a fixing component, wherein the puncture component is used for being implanted on a valve leaflet on one side, the fixing component is used for being implanted on a valve leaflet on the other side, the puncture component comprises at least one puncture part used for puncturing the valve leaflet on one side, the puncture part is combined with the fixing component after sequentially puncturing the valve leaflet on the one side and the valve leaflet on the other side, and the valve leaflets on two sides are connected with the fixing component at least partially through the puncture component.

2. The edge-to-edge repair device according to claim 1, wherein the piercing member further comprises a piercing base, the piercing portion being provided on a side of the piercing base facing the fixing member; the fixing piece comprises a fixing base and a containing part arranged on one side of the fixing base facing the puncture piece, and the puncture part punctures the valve leaf and then is connected with the containing part.

3. The edge-to-edge repair device according to claim 2, wherein the piercing portion and the receiving portion are connected by interference fit, key, elastic deformation, snap, or thread.

4. The edge-to-edge repair device according to claim 3, wherein the piercing portion comprises a tapered needle, and the receiving portion is provided with a receiving cavity into which the needle is inserted.

5. The device according to claim 4, wherein the needle has a protrusion or a flange at a proximal end thereof, and a groove or a hole corresponding to the protrusion or the flange is formed in a sidewall of the receiving cavity, and the needle is inserted into the receiving cavity such that the protrusion or the flange is engaged with the groove or the hole.

6. The edge-to-edge repair device according to claim 2, wherein the side of the puncture base facing the leaflet is provided with a first anti-slip gasket and/or the side of the fixation base facing the leaflet is provided with a second anti-slip gasket, and the first anti-slip gasket and the second anti-slip gasket are made of biocompatible polymer material with higher friction coefficient.

7. The edge-to-edge repair device according to claim 1, wherein the distal end of the piercing portion is provided with a protective sheath.

8. An edge-to-edge repair system comprising the edge-to-edge repair device and delivery device according to any one of claims 1 to 7, wherein the delivery device comprises a push rod and a clamping assembly, the proximal end of the clamping assembly is connected to the push rod, the clamping assembly comprises two clamping arms capable of being opened and closed relatively, the puncture element and the fixing element of the edge-to-edge repair device are respectively pre-assembled on the two clamping arms, and the push rod moves axially and proximally to drive the two clamping arms to close each other, so that the puncture part of the puncture element is combined with the fixing element after puncturing the valve leaflet.

9. The rim-to-rim repair system of claim 8, further comprising a stabilizing assembly including an outer sheath sleeved over the push rod and a positioning member disposed at a distal end of the outer sheath for supporting the leaflets.

10. The edge-to-edge repair system according to claim 9, wherein the stabilizing assembly further comprises a positioning arm movably inserted into the sheath, a distal end of the positioning arm extends out of the sheath, and the positioning member is disposed at a distal end of the positioning arm.

11. The edge-to-edge repair system according to claim 10, wherein the positioning member extends out of the sheath tube along with the axial movement of the positioning arm and extends obliquely toward the axis away from the sheath tube, and the included angle between the axial direction of the positioning member and the axial direction of the positioning arm ranges from 120 degrees to 150 degrees.

12. The edge-to-edge repair system according to claim 10, wherein the number of the positioning arms is two, the two positioning arms are oppositely disposed at intervals, the distal end of each positioning arm is provided with at least one positioning element, and each positioning element extends from the distal end of the positioning arm connected thereto to be away from the axial line and to be inclined toward the distal end.

13. The edge-to-edge repair system of claim 10, wherein the width of the positioning member parallel to the radial direction is greater than the radial dimension of the positioning arm.

14. The edge-to-edge repair system of claim 13, wherein the positioning element is a deformable mesh cage; the middle part of the cylinder mould is columnar, and the proximal end part and the distal end part are both cones.

15. The edge-to-edge repair system of claim 10, wherein the positioning member is at least partially made of an X-ray opaque material.

16. The edge-to-edge repair system of claim 8, wherein the adjacent proximal ends of the two clamping arms are hinged to each other, the clamping assembly further comprising a pusher that moves axially distally to bring the distal ends of the two clamping arms away from each other; the pushing piece moves towards the near end along the axial direction to drive the far ends of the two clamping arms to approach each other, so that the fixing piece is combined with the puncture piece.

17. The edge-to-edge repair system according to claim 16, wherein the proximal ends of the two clamping arms are respectively provided with a sliding groove inclined to the axial direction, and the pushing member comprises a driving pin slidably inserted in the sliding groove, and the driving pin slides in the sliding groove to drive the two clamping arms to rotate relatively.

18. The edge-to-edge repair system of claim 16, wherein the clamping assembly further comprises a retaining sleeve sleeved over the pusher member, a distal end of the retaining sleeve being axially disposed with two legs spaced apart from each other, and proximal ends of the two clamping arms being received between the two legs and connected thereto by a connecting shaft.

19. The edge-to-edge repair system according to claim 12, wherein the distal end of the side of each clamping arm facing the other clamping arm is provided with spaced through holes, the piercing member and the fixing member are respectively provided with threading holes, the piercing member and the fixing member are respectively disposed between the two clamping arms, at least one thread is threaded through the threading hole of the piercing member and the through hole of the corresponding clamping arm, at least one thread is threaded through the threading hole of the fixing member and the through hole of the corresponding clamping arm, and the proximal end of each thread extends from the proximal end of the clamping arm.

20. The edge-to-edge repair system according to claim 12, wherein the distal end of the side of each gripper arm facing the other gripper arm is provided with a positioning slot, and the piercing member and the fixing member are pre-mounted in the positioning slots of the two gripper arms, respectively.

Images