Annuloplasty implant and transcatheter valve repair system

Abstract

The invention provides an annuloplasty implant and a transcatheter valve repair system. An annuloplasty implant includes a plurality of anchors, a flexible contraction member, and a contraction limiting member. The multiple anchoring parts are configured to be implanted into the tissue and comprise the head end anchoring part, the middle anchoring part and the tail end anchoring part which are sequentially arranged in the circumferential direction of the tissue. The flexible contraction member connects the plurality of anchors and is configured to adjust a pitch of the plurality of anchors. A constriction member connects the flexible constriction member and is located between the head end anchor and the tail end anchor, the constriction member being configured to define a spacing of the head end anchor and the tail end anchor. In the application, the shrinkage limiting piece capable of limiting the distance between the head-end anchoring piece and the tail-end anchoring piece is arranged between the head-end anchoring piece and the tail-end anchoring piece, so that the distance between the left and right fiber triangles cannot be obviously changed when the valve ring is shrunk, and the treatment effect of an operation is guaranteed.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an annuloplasty implant and a transcatheter valve repair system. Background Art

[0002] Heart disease is one of the major health threats worldwide, among which heart valve disease is the most common. For heart valve disease caused by mitral or tricuspid valve lesions, treatment through transcatheter interventional surgery has become increasingly common. The current mainstream interventional surgery options include artificial chord implantation, edge-to-edge repair, and annuloplasty. Among them, annuloplasty for the dilated mitral valve annulus can reshape the annulus and / or reduce the size of the annulus, so that the leaflets can fit together during ventricular contraction, reducing or eliminating blood reflux. For example, multiple anchors slidably connected to a rope can be implanted in the annulus of the mitral valve in sequence through the femoral vein or the left atrium, and then the rope can be tightened at one end to shorten the distance between the anchors on the annulus, thereby driving the annular tissue and reducing the annular circumference. However, this method of reducing the annulus will cause the left and right fiber triangles of the annulus to move closer to each other, thereby affecting the activity of the anterior annulus of the mitral valve. In severe cases, it will even destroy the activity of the anterior annulus, which will in turn aggravate the blood reflux of the mitral valve. Summary of the invention

[0003] The embodiment of the present application provides an annuloplasty implant, comprising a plurality of anchors, a flexible contraction member, and a contraction limiting member. The plurality of anchors are configured to be implanted into tissue, and the plurality of anchors include a head end anchor, an intermediate anchor, and a terminal anchor arranged in sequence along the circumference of the tissue. The flexible contraction member connects the plurality of anchors and is configured to adjust the spacing of the plurality of anchors. The contraction limiting member is connected to the flexible contraction member and is located between the head end anchor and the terminal anchor, and the contraction limiting member is configured to limit the spacing between the head end anchor and the terminal anchor.

[0004] The embodiment of the present application also provides a transcatheter valve repair system, comprising a first conveying member, a second conveying member and the above-mentioned annuloplasty implant. The first conveying member is releasably connected to one end of the flexible contraction member, and the second conveying member is releasably connected to the other end of the flexible contraction member; the first conveying member and the second conveying member connect the flexible contraction member and the contraction member to the plurality of anchoring members to form a closed annular structure.

[0005] The annuloplasty implant and transcatheter valve repair system according to the embodiments of the present application are configured with a constricting member capable of defining the distance between the proximal anchor and the distal anchor. At this time, since the proximal anchor and the distal anchor are respectively located at the left fibrous trigone and the right fibrous trigone of the valve annulus, the setting of this constricting member can ensure that the distance between the left and right fibrous trigones does not change significantly when the valve annulus contracts, avoiding the influence on the movement of the anterior mitral valve annulus due to the abutment of the head and tail anchors in the prior art, and even reducing the risk of exacerbating blood reflux, thus ensuring the therapeutic effect of the surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the background art, the drawings required for use in the embodiments of the present application or the background art will be described below.

[0007] Figure 1 is a schematic diagram of an annuloplasty implant implanted in the mitral valve annulus according to some embodiments;

[0008] Figure 2 a-2b shows a three-dimensional structure diagram and a cross-sectional view of the constricting member of the first embodiment;

[0009] Figure 3 is Figure 2 an exploded schematic diagram of the constricting member in ;

[0010] Figure 4 shows Figure 2 the schematic structural diagram of the anchor and the flexible contraction member cooperating with the constricting member in ;

[0011] Figure 5 shows Figure 2 placing the constricting member in Figure 4 the three-dimensional schematic diagram after;

[0012] Figure 6 a-6b shows a three-dimensional structure diagram and a cross-sectional view of the constricting member of the second embodiment;

[0013] Figure 7 is Figure 6 an exploded schematic diagram of the constricting member in ;

[0014] Figure 8 a shows Figure 6 the schematic structural diagram of the limiting tube in ;

[0015] Figure 8 b-8c shows Figure 8 the schematic structural diagram of the fixing member cooperating with the limiting tube in a;

[0016] Figure 9 shows Figure 8Stereoscopic schematic diagram of an annuloplasty implant implanted in the mitral valve annulus;

[0017] Figures 10 - 11 Stereoscopic structural diagram and implantation state diagram of the constriction member of the third embodiment are shown;

[0018] Figure 12 Schematic structural diagram of a transcatheter valve repair system according to some embodiments;

[0019] Figure 13 Shows Figure 12 Schematic structural diagram of the transcatheter valve repair system in [[ ]] including a delivery sheath, an inner sheath and an outer sheath;

[0020] Figure 14 Schematic structural diagram of an anchor and a driving tool;

[0021] Figure 15 Shows Figure 13 Schematic diagram of the implantation process of implanting multiple anchors circumferentially in the mitral valve annulus in [[ ]];

[0022] Figure 16 Shows Figure 13 Schematic diagram of the completed state of implanting multiple anchors in [[ ]];

[0023] Figure 17 Shows pulling out Figure 16 The flexible contraction member in [[ ]] out of the body;

[0024] Figure 18 Shows threading Figure 17 The flexible contraction member in [[ ]] into the constriction member and establishing a connection between the second delivery member and the flexible contraction member;

[0025] Figure 19 Shows using a pusher to Figure 18 Push the constriction member in [[ ]] into the heart;

[0026] Figure 20 Shows Figure 19 The state diagram of the constriction member in [[ ]] located between the head anchor and the end anchor;

[0027] Figure 21 Shows using Figure 13 The transcatheter valve repair system in [[ ]] to push the annuloplasty implant of the second embodiment to the mitral valve annulus;

[0028] Figure 22 Shows Figure 21 The state diagram of the completed implantation of multiple anchors in [[ ]];

[0029] Figure 23 Shows using a pusher toFigure 6 Schematic diagram of pushing the constrictor into the heart

[0030] Figure 24 Shows Figure 23 Schematic diagram of the state where the constrictor in [[ ]] is pushed near the mitral annulus

[0031] Figure 25 Shows Figure 24 Schematic diagram of the state where the constrictor in [[ ]] is located between the proximal anchor and the distal anchor Detailed implementation mode

[0032] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without making creative efforts belong to the scope of protection of the present application.

[0033] The defined terms "proximal" and "distal" in the present application are common terms in the field of interventional medicine. Specifically, "distal" refers to the end far from the operator during the surgical operation, and "proximal" refers to the end close to the operator during the surgical operation. The axial direction refers to the direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction. Unless otherwise defined, all technical and scientific terms used in the present application have the same meaning as commonly understood by those skilled in the technical field to which the present application belongs. The common terms used in the present application in the specification are only for the purpose of describing specific implementation modes and should not be construed as a limitation of the present application.

[0034] In the description of the present application, it should be noted that unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a movable connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two components or the interaction relationship between two components. In the present application, the fixed connection methods include integral molding, welding, riveting, bonding, threaded connection, snap connection, and other connection methods that can achieve relative fixation of two components.

[0035] The directional terms mentioned in the embodiments of the present application, such as "upper", "lower", "left", "right", "inner", "outer", etc., are only with reference to the directions in the accompanying drawings. Therefore, the directional terms used are for better and clearer illustration and understanding of the embodiments of the present application, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the embodiments of the present application. "Plurality" means at least two.

[0036] In the embodiments of the present application, the terms "first", "second", "third" are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first", "second", "third" may explicitly or implicitly include one or more of such features.

[0037] In the embodiments of the present application, the character " / " generally indicates that the associated objects before and after are in an "or" relationship. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0038] The present disclosure provides many different embodiments or examples for implementing different structures of the present application. It can be understood that the specific embodiments described herein are only for explaining the relevant application and not for limiting the application. Additionally, it should be noted that for ease of description, only the parts related to the application are shown in the drawings. The present application will be described in detail below with reference to the drawings and in combination with the embodiments.

[0039] Please refer to Figure 1 , an annuloplasty implant 10 is provided in the embodiments of the present application, which includes a plurality of anchor members 11, a flexible contraction member 13, and a constriction member 15. Specifically, the plurality of anchor members 11 are configured to be implanted into tissue and include a head anchor member 111, an intermediate anchor member 112, and a tail anchor member 113 arranged in sequence along the circumference of the tissue. The flexible contraction member 13 is connected to the plurality of anchor members 11 and is configured to adjust the spacing between the plurality of anchor members 11. The constriction member 15 is connected to the flexible contraction member 13 and is located between the head anchor member 111 and the tail anchor member 113. The constriction member 15 is configured to limit the spacing between the head anchor member 111 and the tail anchor member 113. Among them, the constriction member 15 has an axial length and is an axially non-compressible slender member, that is, the compression amount of the constriction member 15 is basically zero when axially stressed. The plurality of anchor members 11, the flexible contraction member 13, and the constriction member 15 together construct a D-shaped closed ring structure, that is, the annuloplasty implant 10 forms a D-shaped closed ring structure.

[0040] In the annuloplasty implant 10 of the present application, the proximal anchor 111 and the distal anchor 113 are respectively located at the left fibrous trigone and the right fibrous trigone of the mitral valve annulus, and a plurality of intermediate anchors 112 are spaced and located on the posterior annulus between the proximal anchor 111 and the distal anchor 113. By arranging the constriction member 15 between the proximal anchor 111 and the distal anchor 113, the present application ensures that when the annulus contracts, the distance between the left and right fibrous trigones does not change significantly, thus ensuring the therapeutic effect of the surgery and avoiding the risk of surgical failure caused by the prior art that easily affects the movement of the anterior mitral annulus and exacerbates mitral regurgitation.

[0041] Of course, in order to ensure that the D-shaped closed annular structure jointly constructed by the plurality of anchors 11, the flexible contraction member 13, and the constriction member 15 can be maintained at a suitable tension for a long time, the annuloplasty implant 10 further includes a lock 17. The lock 17 is connected to the flexible contraction member 13 and is configured to lock the length of the flexible contraction member 13 to maintain the tension of the flexible contraction member 13. Specifically, the lock 17 can lock at least one free end of the flexible contraction member 13 near the distal anchor 113 and the constriction member 15 to tighten the mitral valve annulus. At this time, the flexible contraction member 13 does not need to be cut, thereby reducing the surgical steps and improving the surgical success rate.

[0042] Please refer to Figure 2 and Figure 3 As shown, in the first embodiment of the present invention, the constriction member 15 is a flexible tubular member to avoid difficult delivery during the delivery process. Specifically, the constriction member 15 includes at least two inner tubes 151 and an elastic outer tube 152, and at least two inner tubes 151 are axially stacked and disposed in the elastic outer tube 152. In some embodiments, the at least two inner tubes 151 include a first inner tube 151a and a second inner tube 151b. One end of the elastic outer tube 152 is fixedly connected to the first inner tube 151a, and the other end of the elastic outer tube 152 is fixedly connected to the second inner tube 151b.

[0043] For some applications, the first inner tube 151a is fixed to the proximal end inside the elastic outer tube 152 by laser welding, and the second inner tube 151b is fixed to the distal end inside the elastic outer tube 152 by laser welding. The elastic outer tube 152 can be an axially incompressible spring tube. Specifically, the first inner tube 151a and the second inner tube 151b respectively have a head end with an increased outer diameter, and the head end is used to respectively abut against both ends of the spring tube 152 to strengthen the connection.

[0044] Of course, in some other embodiments, the at least two inner tubes 151 further include at least one third inner tube 151c located between the first inner tube 151a and the second inner tube 151b to form a constrictor 15 having a plurality of inner tubes. Wherein, the flexible contraction member 13 at least axially extends through one of the at least two inner tubes 151; for example, one end of the flexible contraction member 13 can axially extend through the constrictor 15 as a whole to engage with the other end of the flexible contraction member 13 to form a D-shaped closed ring structure for the locker 17 to lock.

[0045] It can be understood that each of the above inner tubes may not be fixed to each other, so that the constrictor 15 can have a certain bending performance when subjected to a radial force, ensuring its smoothness during transportation. At the same time, in view of the fact that the plurality of inner tubes are all made of rigid materials, after the flexible contraction member 13 is tightened to an appropriate tension, the plurality of inner tubes can maintain rigidity in the axial direction under the guidance of the flexible contraction member 13 without showing a bent state, thereby ensuring that the distance between the proximal anchor 111 and the distal anchor 113 does not change significantly. For some applications, the number of the third inner tubes 151c is preferably 4-6; and, the total distance between the inner tubes cannot be greater than 1 / 3 of the outer diameter of the inner tubes to ensure a small gap and no misalignment. Of course, in order to avoid installation errors during installation, in some embodiments, at least one of the first inner tube 151a and the second inner tube 151b is provided with a visible mark for distinction.

[0046] Furthermore, in order to ensure the biocompatibility of the constrictor 15 to help the constrictor 15 complete endothelialization faster, the constrictor 15 further includes a film 153 covering the elastic outer tube 152. Wherein, the film 153 is a biocompatible film, and the film can be connected to the elastic outer tube 152 by suture.

[0047] Please refer to Figure 4As shown, in some embodiments, to avoid the phenomenon that the flexible contraction member 13 slides arbitrarily on the plurality of anchoring members 11 and the constriction members 15, the flexible contraction member 13 includes a flexible line 131 and a fixing member 132. Among them, each anchoring member 11 is provided with a connection hole 110, and the connection hole 110 is configured to allow the flexible line 131 to pass through. The fixing member 132 is connected to the flexible line 131 so that the flexible line 131 forms a first section 131a and a second section 131b, and the length of the second section 131b is greater than the length of the first section 131a. The fixing member 132 is restricted outside the connection hole 110 of the anchoring member 11, especially restricted outside the connection hole 110 of the first-end anchoring member 111, thereby positioning one end of the flexible contraction member 13 outside the first-end anchoring member 111 all the time, so as to avoid that after the flexible contraction member 13 slips out of the first-end anchoring member 111, it is impossible to observe whether the flexible contraction member 13 returns to its position through medical images such as DSA and / or ultrasound.

[0048] For some applications, the flexible line 131 is folded in half to form two free ends, and the fixing member 132 is tubular and crimps the two free ends inside the fixing member 132, thereby forming a U-shaped first section 131a and a U-shaped second section 131b. Among them, the outer diameter of the fixing member 132 is greater than the inner diameter of the connection hole 110, and the axial length of the first section 131a is 2 mm - 5 mm longer than the axial length of the fixing member 132. The flexible line 131 is a flexible linear material, such as a wire, a filament, a rope, a strip, a belt, etc., and its radial cross-sectional shape can be circular, oval, rectangular, square or other shapes, etc., and the present application does not limit this. The flexible line 131 can be made of a metal material and / or a polymer material, preferably a material with biocompatibility, such as stainless steel 316L, tungsten, tantalum, nitinol, polyethylene, polyamide, polypropylene, polyurethane, etc.

[0049] At the same time, please refer to Figure 5As shown, in order to prevent the fixing member 132 from interfering with the locking of the flexible contraction member 13 by the lock 17, the present application confines the fixing member 132 within the constriction member 15. Specifically, one of the first inner tube 151a and at least one third inner tube 151c is configured to prevent the fixing member 132 from passing through, the second inner tube 151b is configured to allow the fixing member 132 to pass through, and the first section 131a is configured to be able to extend out of the first inner tube 151a. For some applications, the first inner tube 151a, the second inner tube 151b, and the third inner tube 151c are all provided with coaxial hollow channels to allow the flexible contraction member 13 to pass through. Among them, the inner diameter of the hollow channel of the first inner tube 151a or the inner diameter of the hollow channel of at least one third inner tube 151c is smaller than the outer diameter of the fixing member 132 to prevent the fixing member 132 from passing through the hollow channel; while the inner diameter of the hollow channel of the second inner tube 151b is larger than the outer diameter of the fixing member 132 to ensure that the fixing member 132 can pass through smoothly. Then, when the fixing member 132 is restricted from passing through and is housed within the constriction member 15, the first section 131a of the flexible wire 131 can extend out of the hollow channel of the first inner tube 151a to engage with the free end of its second section 131b to form a D-shaped closed loop structure for the lock 17 to lock.

[0050] In the second embodiment of the present invention, please refer to Figures 6 - 7 As shown, the difference in the structure of the constriction member 15 from that of the first embodiment is that the constriction member 15 further includes a connecting ring 154 and a limiting tube 155. The connecting ring 154 is fixedly provided at one end of the first inner tube 151a away from the third inner tube 151c, and the limiting tube 155 is fixedly provided in one of the at least two inner tubes 151. Specifically, the connecting ring 154 is a U-shaped closed ring extending axially along the extension of the hollow channel of the first inner tube 151a for the free end of the second section 131b of the flexible wire 131 to pass through the connecting ring 154 to form a closed loop, thereby replacing the way in the first embodiment of extending the first section 131a of the flexible wire 131 out of the hollow channel of the first inner tube 151a to engage with its second section 131b to form a closed loop. And the limiting tube 155 is used to clamp the fixing member 132 to prevent the first section 131a of the flexible wire 131 and the fixing member 132 from detaching from the limiting tube 155. For some applications, the second inner tube 151b is a tubular member with a proximal inner diameter larger than the distal inner diameter (i.e., the head end inner diameter) for the limiting tube 155 to be inserted from the proximal opening of the second inner tube 151b and fixed, such as by laser welding, to the proximal inner diameter part. At this time, the distal end face of the limiting tube 155 will abut against the interface formed by the proximal inner diameter and the distal inner diameter of the second inner tube 151b, and the proximal end face of the limiting tube 155 does not extend beyond the proximal opening of the second inner tube 151b.

[0051] In this second embodiment, as Figure 8As shown, in order to ensure the limiting and engaging of the limiting tube 155 and the fixing member 132, the limiting tube 155 has at least two elastic pieces 1551 that deviate towards its central axis. The fixing member 132 includes a guiding section 132a near the first section 131a of the flexible wire 131 and a crimping section 132b near its second section 131b. Among them, an abutting surface 132c is formed between the guiding section 132a and the crimping section 132b. The limiting tube 155 is configured to allow the fixing member 132 to pass through, and the elastic pieces 1551 abut against the abutting surface 132c to limit the fixing member 132 from detaching from the limiting tube 155. That is, the inner diameter of the limiting tube 155 is greater than the maximum outer diameter of the guiding section 132a, and the distance between the two elastic pieces 1551 is less than the maximum outer diameter of the guiding section 132a. Thus, when the fixing member 132 is clamped to the limiting tube 155 in the manner as Figure 9 shown, the first section 131a of the flexible wire 131 will be received in the constriction member 15, for example, received in the third inner tube 151c, and will not exceed the proximal opening of the first inner tube 151a. And the free end of the second section 131b of the flexible wire 131 will pass through the connecting ring 154 on the constriction member 15 to form a D-shaped closed ring structure for the lock 17 to lock. For some applications, the limiting tube 155 is formed with elastic pieces 1551 by cutting a cylindrical pipe. The cutting method can be laser cutting or machining. The material can be a NITI tube and the elastic pieces 1551 are formed by heat setting, or it can also be a stainless steel tube and the elastic pieces 1551 are formed by physical bending.

[0052] Of course, in the third embodiment of the present invention, as Figures 10 - 11 shown, the constriction member 15 is an elongated rigid member, including a plate-like element 156 and at least two connecting rings 157 fixedly provided on the plate-like element 156. The connecting rings 157 are configured to be connected to the flexible contraction member 13. Specifically, the two connecting rings 157 extend upward from both ends of the plate-like element 156 and are spaced apart. Each connecting ring 157 is provided with an axially penetrating through hole for the flexible contraction member 13 to pass through; among them, the inner diameter of the through hole is greater than the diameter of the flexible wire 131 and the outer diameter of the fixing member 132 to allow both to pass through smoothly. And, the first section 131a of the flexible contraction member 13 can extend out of the connecting ring 157 near the end anchor 113 to engage with the free end of the second section 131b to form a D-shaped closed ring structure and be locked by the lock 17.

[0053] Please refer to Figure 12, the present invention also provides a transcatheter valve repair system 100, including the above annuloplasty implant 10, a first delivery member 20 and a second delivery member 30. The first delivery member 20 is releasably connected to one end of the flexible contraction member 13, and the second delivery member 30 is releasably connected to the other end of the flexible contraction member 13. The first delivery member 20 and the second delivery member 30 connect the flexible contraction member 13 and the constriction member 15 to a plurality of anchors 11 to form a closed annular structure. For some applications, the first delivery member 20 is connected to the flexible contraction member 13 in a U shape. Specifically, the first delivery member 20 passes through the first U-shaped section 131a of the flexible contraction member 13 and is folded in half to be connected to the first section 131a in a U shape. The second delivery member 30 is connected to the flexible contraction member 13 in a U shape. Specifically, the second delivery member 30 passes through the second U-shaped section 131b of the flexible contraction member 13 and is folded in half to be connected to the second section 131b in a U shape. Wherein, the first delivery member 20 and the second delivery member 30 can respectively extend to the outside of the body. Then, when the flexible contraction member 13 and the constriction member 15 outside the body are connected to a plurality of anchors 11 inside the body by using the first delivery member 20 and the second delivery member 30 to form a contracted closed annular structure and locked by a lock 17, one end is released outside the body and the other end is pulled to withdraw the first delivery member 20 and the second delivery member 30. In view of the fact that in the present application, the flexible contraction member 13 is indirectly pulled out of the body by the first delivery member 20 and the second delivery member 30, the axial length of the flexible contraction member 13 is relatively short. Therefore, there is no need to intervene a tangential tool to cut the flexible contraction member 13, thereby reducing the surgical steps and improving the surgical success rate.

[0054] In the present application, in order to smoothly deliver the annuloplasty implant 10 along a preset path to the interior of the heart, please refer to Figures 13 - 14As shown, the transcatheter valve repair system 100 also includes a delivery sheath 40, which is constructed to deliver multiple anchors 11 and a flexible contraction member 13 to the mitral valve annulus along a preset path. Specifically, the tube wall of the delivery sheath 40 is provided with a through groove 400 extending from the distal end to the proximal end, and the through groove 400 is connected to the inner cavity of the delivery sheath 40, and the distal end of the through groove 400 has an opening. Each anchor 11 includes an anchor 11a and a connecting structure 11b that can be rotatably sleeved on the anchor 11a, and the connecting structure 11b defines a connecting hole 110, and the connecting hole 110 is configured to be connected to the flexible contraction member 13. Furthermore, the connecting structure 11b also has a guide portion 110b, and when the anchor 11a is movably installed in the inner cavity of the delivery sheath 40, the guide portion 110b can be axially moved and located in the through groove 400. In particular, the connection hole 110 of the connection structure 11b is at least partially located outside the delivery sheath 40, so that the flexible contraction member 13 is installed in the connection hole 110 outside the delivery sheath 40 and is located outside the delivery sheath 40 as a whole. Due to the restriction of the through groove 400 on the guide portion 110b, the rotation of the connection structure 11b can be avoided. In addition, a driving tool 50 is movably installed in the delivery sheath 40 and is constructed to be detachably connected to the head 11c of the anchor 11 to drive the anchor 11 to be implanted into the tissue. Among them, the head 11c is formed by extending from the proximal end of the anchor 11a and is fixedly connected to each other, and the connection structure 11b is rotatably sleeved in the circumferential groove opened on the head 11c to realize the relative rotation of the connection structure 11b and the anchor 11a. It is understandable that the distal end of the driving tool 50 and the proximal end of the head 11c can be connected by special-shaped buckles such as S-shaped buckles, threaded connections, magnetic suction or other detachable connection methods, which are not limited here; and the anchor 11a can be made of stainless steel, titanium alloy or cobalt alloy.

[0055] Of course, the transcatheter valve repair system 100 further includes an outer sheath 60 and an inner sheath 70 movably mounted in the outer sheath 60, and the delivery sheath 40 is movably mounted in the inner sheath 70, that is, the delivery sheath 40, the inner sheath 70 and the outer sheath 60 are movably mounted in sequence from the inside to the outside. It can be understood that the outer sheath 60 and the inner sheath 70 are constructed to establish a delivery path from the patient's body to the mitral valve annulus, and the delivery sheath 40 can deliver multiple anchors 11 to the mitral valve annulus by pushing it distally in the preset delivery path. Preferably, both the outer sheath 60 and the inner sheath 70 are sheaths with a bending adjustment function, and the bending degree and direction of the distal part thereof can be adjusted so that the delivery sheath 40 can easily reach the vicinity of the mitral valve annulus.

[0056] In some embodiments, both the first delivery member 20 and the second delivery member 30 are at least partially located between the inner sheath 70 and the delivery sheath 40 (not shown in the figure). Of course, in order to avoid the problem that the first delivery member 20 and the second delivery member 30 are likely to be entangled or interfered with each other in the same space, in some other embodiments, the first delivery member 20 is at least partially located between the outer sheath 60 and the inner sheath 70, and the second delivery member 30 is at least partially located between the inner sheath 70 and the delivery sheath 40. Hereinafter, taking the first delivery member 20 and the second delivery member 30 being located in different spaces as an example, the use process and working principle of the transcatheter valve repair system 100 of the present invention will be described in detail.

[0057] As Figure 15 shown, during installation, first, the proximal anchor 111 is loaded at the distal end of the delivery sheath 40, and then the flexible contraction member 13 is further threaded through the connection hole 110 to be slidably connected to the connection hole 110. Specifically, the second section 131b of the flexible wire 131 is threaded through the connection hole 110, and the first section 131a thereof is continuously restricted to one side of the connection hole 110 by the fixing member 132 to prevent the flexible contraction member 13 from slipping out of the proximal anchor 111. In view of the short axial length of the flexible contraction member 13 and its inability to extend out of the patient's body, at this time, the first delivery member 20 and the second delivery member 30 respectively releasably connect their distal ends to both ends of the flexible contraction member 13, and the delivery sheath 40, the first delivery member 20 and the second delivery member 30 are pre-sleeved in the inner sheath 70. At this time, the first delivery member 20 can extend proximally from the outside of the inner sheath 70, while the second delivery member 30 can extend proximally through the internal space defined between the inner sheath 70 and the delivery sheath 40 until it exits the inner sheath 70.

[0058] Once the installation is completed, the delivery path is started to be constructed. Specifically, the outer sheath 60 inserts its distal end into the femoral vein at the patient's groin and is advanced to reach the inferior vena cava and then enters the right atrium inside the heart. When a suitable puncture tool is used to puncture the atrial septum inside the heart, the distal end of the outer sheath 60 will further enter the left atrium through the atrial septum to position its distal opening inside the left atrium, thereby establishing a delivery path from outside the patient's body to the mitral valve annulus. Then, the installed inner sheath 70 and the delivery sheath 40 are synchronously advanced distally along the delivery path established by the outer sheath 60 into the heart until the distal end of the inner sheath 70 exceeds the distal opening of the outer sheath 60, and the implantation operation is started.

[0059] Specifically, first, the delivery sheath 40 is advanced distally so that its distal end extends beyond the distal opening of the inner sheath 70 and abuts against the left fibrous trigone. Then, the driving tool 50 is advanced spirally distally to push the anchor 11a of the proximal end anchor 111 out of the distal end of the delivery sheath 40 and anchor it into the left fibrous trigone; at this time, the guiding portion 110b is driven to axially move from the proximal end of the through groove 400 to its distal end. Once the proximal end anchor 111 is successfully anchored, the driving tool 50 is manipulated to disengage the proximal end anchor 111 from the distal end of the driving tool 50. Finally, the driving tool 50 and the delivery sheath 40 are retracted, leaving the flexible contraction member 13. At this time, both ends of the flexible contraction member 13 extend to the outside of the body through the first delivery member 20 and the second delivery member 30 respectively, facilitating the threading of the intermediate anchor 112, the distal end anchor 113, the lock 17, etc.

[0060] Repeat the above operations to thread the second delivery member 30 into the delivery sheath 40 loaded with the intermediate anchor 112 or the distal end anchor 113, and continue to use the delivery sheath 40 to deliver and implant the intermediate anchor 112 until the distal end anchor 113 is implanted into the right fibrous trigone. After a plurality of intermediate anchors 112 and distal end anchors 113 are sequentially implanted circumferentially along the annulus, the plurality of anchors 11 will be connected by the second segment 131b of the flexible wire 131, and the first segment 131a of the flexible wire 131 will be restricted by the fixing member 132 and always be on the other side of the connection hole 110 of the proximal end anchor 111. In some embodiments, in order to ensure that the implantation area of the anchor 11 on the mitral annulus is large enough to achieve the desired effect of reducing the annulus, the angle between the proximal end anchor 111 and the distal end anchor 113 implanted on the mitral annulus is between 180° and 260°.

[0061] After all the above anchors 11 are implanted, the driving tool 50, the delivery sheath 40, and the inner sheath 70 are withdrawn. At this time, the flexible contraction member 13, the first delivery member 20, and the second delivery member 30 will present a state as shown in Figure 16 shown, the first delivery member 20 and the second delivery member 30 will be in the same space and simultaneously extend proximally through the outer sheath 60 to the outside of the body. Specifically, the second segment 131b of the flexible wire 131 connects the plurality of anchors 11, passes through the distal end anchor 113 and then connects to the second delivery member 30. However, the fixing member 132 is restricted by the connection hole 110 of the proximal end anchor 111 and cannot pass through the connection hole 110, thereby restricting the first segment 131a and the second segment 131b of the flexible wire 131 on both sides of the proximal end anchor 111 respectively.

[0062] Next, the linear distance between the proximal anchor 111 and the distal anchor 113 is measured by DSA and / or ultrasound to select a properly sized constrictor 15. Preferably, the length of the constrictor 15 is determined by the positions of the proximal anchor 111 and the distal anchor 113. A gap is formed between the constrictor 15 and the proximal anchor 111, and a gap is formed between the constrictor 15 and the distal anchor 113. The preferred ranges of these two gaps are 0 - 5 mm respectively, based on which a suitable constrictor 15 is selected. Then, when pulling the first delivery member 20 in vitro in the manner as shown in Figure 17 to pull the first section 131a of the flexible contraction member 13 out of the body, the flexible contraction member 13 will be detached from the connection with the plurality of anchors 11, and the second delivery member 30 will be connected to the plurality of anchors 11. Further in the manner as shown in Figure 18 , the free end of the first delivery member 20 is inserted into the second inner tube 151b of the constrictor 15 and passes out through the first inner tube 151a in vitro. The first delivery member 20 is pulled in vitro to connect the flexible contraction member 13 with the constrictor 15 until its first section 131a is exposed outside the constrictor 15. Then, the second delivery member 30 is passed through the first section 131a in vitro to form an adjustable closed loop. At this time, the fixing member 132 is restricted within the constrictor 15 by the first inner tube 151a, and the axial length of the first section 131a of the flexible contraction member 13 is greater than the axial length of the first inner tube 151a of the constrictor 15 to allow its first section 131a to be exposed outside the constrictor 15.

[0063] Furthermore, as shown in Figure 19 , the transcatheter valve repair system 100 further includes a pusher 80, which is used to push the constrictor 15 between the proximal anchor 111 and the distal anchor 113. Specifically, once an adjustable closed loop structure is formed, the first delivery member 20 is inserted into the hollow channel of the pusher 80 and extends proximally out of the pusher 80. The first delivery member 20 and the second delivery member 30 are tightened in vitro, and the pusher 80 is pushed distally along the delivery path of the outer sheath 60 to push the constrictor 15 out of the distal end of the outer sheath 60. Thus, under the pulling effect in vitro, the plurality of anchors 11 will be switched from being connected to the second delivery member 30 as shown in Figure 17 to being connected to the second section 131b of the flexible contraction member 13 as shown in Figure 20 , and the constrictor 15 is pushed to a suitable position between the proximal anchor 111 and the distal anchor 113. Then, the pusher 80 and the first delivery member 20 are withdrawn, leaving the second delivery member 30 for connection with the lock 17 in vitro.

[0064] Finally, pass the proximal end of the second delivery member 30 through the locker 17, and the locker 17 will push along the second delivery member 30 through the free end of the second section 131b of the flexible contraction member 13. At this time, after using a locking tool to drive the locker 17 to pre-tighten the flexible contraction member 13, withdraw the second delivery member 30. Further drive the locker 17 to tighten the flexible contraction member 13 until the best valve function is presented by the annulus, and then lock the free end of the second section 131b, so as to maintain the tension of the flexible contraction member 13 to keep the effect of reducing the annulus. Among them, the distal end of the locking tool is detachably connected to the locker 17 and extends proximally until it passes through the outer sheath 60. Once the locking is completed, release the locker 17 from the distal end of the locking tool, and withdraw the locking tool, the second delivery member 30 and the outer sheath 60, so as to complete the mitral annuloplasty.

[0065] Certainly, in some embodiments, the transcatheter valve repair system 100 further includes handles respectively disposed at the proximal ends of the outer sheath 60, the inner sheath 70 and the delivery sheath 40, and the three handles are respectively carried on the surgical auxiliary bracket for use during the operation.

[0066] Figures 21 - 25 Shows the use process schematic diagram of the transcatheter valve repair system 100 when the annuloplasty implant 10 is the annuloplasty implant as Figures 6 - 9 shown. Specifically, as Figure 21 shown, the transcatheter valve repair system 100 uses the delivery sheath 40 and the inner sheath 70 to implant a plurality of anchors 11 into the annulus along the delivery path of the outer sheath 60. In view of the implantation process of anchoring a plurality of anchors 11 into the annulus in sequence along the circumference of the annulus in this embodiment being the same as Figure 15 that, it will not be repeated here.

[0067] Then, when all the above-mentioned anchors 11 are implanted and the driving tool 50, the delivery sheath 40 and the inner sheath 70 are withdrawn, the flexible contraction member 13, the first delivery member 20 and the second delivery member 30 will present the state as Figure 22 shown, and the first delivery member 20 and the second delivery member 30 will be in the same space and simultaneously pass through the outer sheath 60 and extend proximally to the outside of the body. Specifically, the second section 131b of the flexible wire 131 is connected to a plurality of anchors 11, passes through the end anchor 113 and is connected to the second delivery member 30. However, the fixing member 132 is restricted by the connection hole 110 of the head anchor 111 and cannot pass through the connection hole 110, so that the first section 131a and the second section 131b of the flexible wire 131 are respectively restricted on both sides of the head anchor 111.

[0068] Next, a sizing member 15 with a suitable size is selected, and the free end of the first delivery member 20 is passed through the second inner tube 151b of the sizing member 15 and out of the first inner tube 151a outside the body to thread the sizing member 15. Further, the free end of the second delivery member 30 is passed through the connection ring 154 outside the body to form an adjustable closed loop structure. At this time, the first section 131a of the flexible contraction member 13 is not connected to the sizing member 15.

[0069] Once the adjustable closed loop structure is formed, the present application will push the sizing member 15 into the heart using a pusher 80 in the manner as Figure 23 shown. Specifically, the free ends of the first delivery member 20 and the second delivery member 30 are both inserted into the hollow channel of the pusher 80 and extend proximally out of the pusher 80. The first delivery member 20 and the second delivery member 30 are tightened outside the body, and the pusher 80 is pushed distally along the delivery path of the outer sheath tube 60 to push the sizing member 15 out of the distal end of the outer sheath tube 60.

[0070] Then, as Figure 24 shown, under the pulling force outside the body, the first section 131a of the flexible contraction member 13 is pulled by the first delivery member 20 and connected to the sizing member 15 until the guiding section 132a of the fixing member 132 is pulled out of the limiting tube 155. At this time, the guiding section 132a will be restricted within the sizing member 15 by the limiting tube 155 and the third inner tube 151c. For example, it is abutted by the elastic piece 1551 of the limiting tube 155 to prevent it from detaching from the limiting tube 155, and is restricted from passing through by the hollow channel of the third inner tube 151c to prevent it from being pulled out of the sizing member 15 by the first delivery member 20. And the sizing member 15 will be further driven by the pusher 80 and delivered to a suitable position between the proximal anchor 111 and the distal anchor 113 in the manner as Figure 25 shown. Then, the pusher 80 and the first delivery member 20 are withdrawn, leaving the second delivery member 30 for connection to the lock 17 outside the body. The lock 17 is used to tighten the flexible contraction member 13 and lock it to the free end of the second section 131b, so as to maintain the tension of the flexible contraction member 13 to keep the effect of reducing the mitral annulus. At this time, the fixing member 132 will be restricted within the sizing member 15 by the limiting tube 155, and the first section 131a of the flexible contraction member 13 is positioned and received within the hollow channel of the third inner tube 151c. Once the locking is completed, the second delivery member 30 and the outer sheath tube 60 are withdrawn to complete the mitral annuloplasty.

[0071] It should be noted that, without conflict, the embodiments and features in the embodiments of the present application can be combined with each other, and any combination of features in different embodiments is also within the protection scope of the present application. That is to say, the above-described multiple embodiments can also be arbitrarily combined according to actual needs.

[0072] It should be noted that all the above-mentioned drawings are exemplary illustrations of the present application and do not represent the actual size of the product. Moreover, the dimensional proportional relationships between components in the drawings are not used as limitations on the actual products of the present application either.

[0073] The above are only some embodiments and implementation manners of the present application. The protection scope of the present application is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present application, and all of them should be covered within the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. An annuloplasty implant, characterized in that, Comprising: A plurality of anchoring members configured to be implanted into tissue, the plurality of anchoring members including a first-end anchoring member, an intermediate anchoring member, and a last-end anchoring member arranged in sequence along the circumference of the tissue; A flexible contraction member connecting the plurality of anchoring members and configured to adjust the spacing between the plurality of anchoring members; A limiting member connecting the flexible contraction member and located between the first-end anchoring member and the last-end anchoring member, the limiting member being configured to define the spacing between the first-end anchoring member and the last-end anchoring member.

2. The annuloplasty implant according to claim 1, wherein The annuloplasty implant further includes a lock connecting the flexible contraction member, the lock being configured to lock the length of the flexible contraction member to maintain the tension of the flexible contraction member.

3. The annuloplasty implant according to claim 1, characterized in that, The limiting member has an axial length and is axially incompressible.

4. The annuloplasty implant according to claim 3, characterized in that, The limiting member includes an elastic outer tube and at least two inner tubes axially stacked in the elastic outer tube, the at least two inner tubes including a first inner tube and a second inner tube, one end of the elastic outer tube being fixedly connected to the first inner tube, and the other end of the elastic outer tube being fixedly connected to the second inner tube.

5. The annuloplasty implant according to claim 4, characterized in that, The at least two inner tubes further include at least one third inner tube located between the first inner tube and the second inner tube.

6. The annuloplasty implant according to claim 5, wherein Each of the anchoring members is provided with a connection hole, the flexible contraction member including a flexible wire and a fixing member connected to the flexible wire to form a first section and a second section of the flexible wire, the length of the second section being greater than the length of the first section, the connection hole being configured to allow the flexible wire to pass through, and the fixing member being restricted outside the connection hole of the first-end anchoring member.

7. The annuloplasty implant according to claim 6, characterized in that, One of the first inner tube and the at least one third inner tube is configured to restrict the passage of the fixing member, the second inner tube is configured to allow the passage of the fixing member, and the first section is configured to be able to extend out of the first inner tube.

8. The annuloplasty implant according to claim 5, wherein, The limiting member further includes a connection ring and a limiting tube, the connection ring being fixedly provided at one end of the first inner tube away from the third inner tube, and the limiting tube being fixedly provided in one of the at least two inner tubes.

9. The annuloplasty implant according to claim 4, wherein The limiting member further includes a film covering the elastic outer tube.

10. The annuloplasty implant according to claim 3, wherein The limiting member includes a plate-shaped element and at least two connection rings fixedly provided on the plate-shaped element, the connection rings being configured to be connected to the flexible contraction member.

11. The annuloplasty implant according to any one of claims 1 to 10, characterized in that, The plurality of anchoring members, the flexible contraction member, and the limiting member form a D-shaped closed ring structure.

12. A transcatheter valve repair system, characterized in that, Including a first delivery member, a second delivery member, and the annuloplasty implant according to any one of claims 1-11, the first delivery member being releasably connected to one end of the flexible contraction member, the second delivery member being releasably connected to the other end of the flexible contraction member, the first delivery member and the second delivery member connecting the flexible contraction member and the limiting member to the plurality of anchoring members to form a closed ring structure.

13. The transcatheter valve repair system according to claim 12, wherein The first delivery member is U-shaped connected to the flexible contraction member, the second delivery member is U-shaped connected to the flexible contraction member, and the first delivery member and the second delivery member respectively extend to the outside of the body.

14. The transcatheter valve repair system according to claim 13, wherein The flexible contraction member includes a flexible line and a fixing member. The fixing member is connected to the flexible line so that the flexible line forms a first section and a second section, and the length of the second section is greater than that of the first section. The first conveying member is U-shapedly connected to the first section, and the second conveying member is U-shapedly connected to the second section.

15. The transcatheter valve repair system according to claim 12, wherein The transcatheter valve repair system further includes a delivery sheath, an inner sheath, and an outer sheath that are movably sleeved on each other from inside to outside in sequence; At least a part of the first conveying member is located between the outer sheath and the inner sheath, and at least a part of the second conveying member is located between the inner sheath and the delivery sheath; Alternatively, both the first conveying member and the second conveying member are at least partially located between the inner sheath and the delivery sheath.

Images