Quick-loading assembly, valve repair system, and valve clip loading method

Abstract

A quick-loading assembly, a valve repair system, and a valve clip loading method. The quick-loading assembly comprises an outer shaft, a mounting device, an actuation shaft, and an actuation wire. The mounting device is connected to a distal end of the outer shaft. The actuation shaft extends through the outer shaft and the mounting device, and is releasably connected to an implant. The actuation wire comprises an elongated main body portion and a protrusion located at a distal end of the main body portion, and is releasably connected to the implant. An engagement slot coupled to the actuation wire is formed on the mounting device. The engagement slot comprises a narrow section and enlarged sections. When the actuation shaft is positioned within the mounting device, the actuation wire extends through the two enlarged sections, and the protrusion is located in one of the two enlarged sections, the actuation shaft restricts the movement of the protrusion.

Description

Fast loading assembly, valve repair system, and method of loading a valve clip

[0001] Cross Reference to Related Applications

[0002] This application claims priority to the Chinese patent application No. 202410477400.5, filed on April 19, 2024, entitled “Fast loading assembly, valve repair system, and method of loading a valve clip”, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present application relates generally to medical devices, systems, and methods of using medical devices. In particular, the present application relates to devices and systems for endovascular, percutaneous, or minimally invasive surgical treatment of body tissue, such as tissue approximation or valve repair, and methods of using the devices. More particularly, the present application relates to valve repair of heart valves and venous valves. BACKGROUND

[0004] Generally, the heart valve repair clip adopts a pre-assembled design, and the clip and the delivery system are assembled when leaving the factory. One delivery system matches one clip, and when multiple clips or devices need to be implanted during surgery or the device fails, the entire system and clip need to be replaced, and the delivery system or clip cannot be replaced individually. Therefore, multiple sets of different specifications and models of devices need to be prepared for backup during surgery, which increases the product inventory and transportation costs. SUMMARY

[0005] To solve the above technical problems, the present disclosure provides a fast loading assembly, a valve repair system, and a method of loading a valve clip, which can quickly load an implant into the fast loading assembly during surgery, and is convenient and efficient to operate.

[0006] A first aspect of the present disclosure discloses a fast loading assembly for loading an implant, comprising an outer shaft, a hanger, and a hanger wire. The hanger is connected to the distal end of the outer shaft, and an actuation shaft extends through the outer shaft and the hanger and is releasably connected to the implant. The actuation wire comprises an elongated main body portion and a protrusion at the distal end of the main body portion, and the actuation wire is releasably connected to the implant. The hanger is provided with an engagement groove coupled with the actuation wire, the engagement groove comprises a narrow portion and at least two enlarged portions in communication with the narrow portion, the narrow portion of the engagement groove is configured to be suitable for the main body portion of the actuation wire to pass and limit the protrusion of the actuation wire to pass, and the enlarged portion of the engagement groove is configured to be suitable for the protrusion of the actuation wire to pass. When the actuation shaft is located in the hanger, the actuation wire extends through the two enlarged portions, and the protrusion is located in one of the two enlarged portions, the actuation shaft limits the movement of the protrusion.

[0007] Optionally, the narrow portion of the engagement slot has different longitudinal heights. Specifically, the enlarged portions are configured as two, one enlarged portion is arranged at each end of the narrow portion, and the narrow portion of the engagement slot is configured as a U shape in the longitudinal direction. Preferably, the two enlarged portions are distributed along the radial direction by 180°. More preferably, the mount is provided with two engagement slots, the two engagement slots are distributed along the longitudinal direction, and the narrow portions of the two engagement slots are located at opposite sides of the mount, respectively. Further, the narrow portion of each engagement slot comprises a transverse segment and two longitudinal segments located at both sides of the transverse segment, the transverse segment is located at the proximal end of the two longitudinal segments, and the two enlarged portions are located at the distal end of the two longitudinal segments, respectively.

[0008] Optionally, the protrusion of the actuation wire is configured as a cone, and the main body portion of the actuation wire is connected to the small cross-section end of the protrusion.

[0009] Optionally, the quick loading assembly further comprises a coupler, the actuation shaft extends through the coupler, and the coupler is releasably connected to the proximal end of the implant. Optionally, the proximal end of the coupler is provided with a limiting slot for limiting the passage of the protrusion of the actuation wire.

[0010] Specifically, the coupler comprises a plurality of flexible arms, the distal end of each flexible arm is provided with a connecting slot, and the inner side of each flexible arm is provided with a locking ring. When the actuation shaft extends through the locking ring, the connecting slot engages the proximal end of the implant to connect the implant to the coupler. More specifically, the flexible arms are configured as two, the two flexible arms are oppositely arranged, the locking ring is located at the distal end of the mount, and the enlarged portion of the engagement slot is aligned with the gap between the two flexible arms.

[0011] A second aspect of the present disclosure discloses a valve repair system comprising a valve clip and a delivery system. The valve clip comprises a connector located at the proximal side and a clip seat located at the distal side, a first clip piece and a second clip piece, a first buckle and a second buckle. Each clip piece is attached to the clip seat and the connector, respectively; each buckle has a fixed end and a free end, and the free end of each buckle is provided with a hole. The fixed end of the first buckle is connected to the first clip piece, and the fixed end of the second buckle is connected to the second clip piece. The delivery system comprises the quick loading assembly of the first aspect of the present disclosure.

[0012] Specifically, the delivery system further comprises an outer catheter and an intermediate catheter. The outer catheter comprises a first sheath, and the outer catheter can be configured to deflect the first sheath; the intermediate catheter comprises a second sheath, and the intermediate catheter can be configured to deflect the second sheath. The second sheath extends coaxially through the first sheath, and the outer shaft extends coaxially through the first sheath and the second sheath.

[0013] A third aspect of the present disclosure discloses a method for loading a valve clip using the quick loading assembly of the first aspect of the present disclosure, comprising the following steps: connecting the connector of the valve clip to the coupler, operating the actuating shaft to extend through the outer shaft and the coupler, and coupling the coupler with the connector; locking the distal end of the actuating shaft with the clip seat in a threaded connection manner; threading the actuating wire through the hole of the buckle, and placing a section of the main body of the actuating wire in the limiting groove of the hanger, and pulling the actuating wire to make the protrusion located in an enlarged part.

[0014] A third aspect of the present disclosure discloses a method for loading a valve clip using the quick loading assembly of the first aspect of the present disclosure, comprising the following steps: connecting the connector of the valve clip to the coupler, operating the actuating shaft to extend through the outer shaft and the coupler, and coupling the coupler with the connector; locking the distal end of the actuating shaft with the clip seat in a threaded connection manner; threading the actuating wire through the hole of the buckle, and placing a section of the main body of the actuating wire in the limiting groove of the hanger, and pulling the actuating wire to make the protrusion located in an enlarged part. BRIEF DESCRIPTION OF DRAWINGS

[0015] In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present disclosure, and other drawings can also be obtained by those skilled in the art without any creative effort based on these drawings.

[0016] FIG. 1 shows a schematic diagram of an implant of the present disclosure;

[0017] FIG. 2 shows a schematic diagram of a delivery system of the present disclosure;

[0018] FIG. 3A shows a schematic diagram of a quick loading assembly of the present disclosure, wherein the coupler is in a coupling configuration;

[0019] FIG. 3B shows a schematic diagram of a quick loading assembly of the present disclosure, wherein the coupler is in a release configuration, and the actuating wire is coupled to the hanger;

[0020] FIG. 3C shows a schematic diagram of a quick loading assembly of the present disclosure, wherein the coupler is in a release configuration, and the actuating wire is separated from the engagement groove of the hanger;

[0021] FIG. 4 shows a schematic diagram of a quick loading assembly of the present disclosure, wherein the coupler is removed;

[0022] FIG. 5 shows a schematic diagram of an embodiment of a hanger of the present disclosure;

[0023] FIG. 6 shows a schematic diagram of another embodiment of a hanger of the present disclosure;

[0024] FIG. 7A, FIG. 7B show schematic views of the mounting device of FIG. 5 in cooperation with the actuation wire, where FIG. 7A shows the actuation shaft loaded first and the actuation wire loaded second, and FIG. 7B shows the actuation wire loaded first and the actuation shaft loaded second;

[0025] FIG. 8 shows a perspective view of the delivery system of the present disclosure coupled with the implant, where the implant is in a closed state;

[0026] FIG. 9 shows a side view of the delivery system of the present disclosure coupled with the implant, where the implant is in a closed state;

[0027] FIG. 10 shows a perspective view of the delivery system of the present disclosure coupled with the implant, where the implant is in an open state and the clasp is in a closed state;

[0028] FIG. 11 shows a perspective view of the delivery system of the present disclosure coupled with the implant, where the implant is in an open state and the clasp is in an open state;

[0029] FIG. 12 shows a schematic view of the delivery system of the present disclosure loading the implant, where the actuation shaft is connected to the cradle;

[0030] FIG. 13 shows a schematic view of the delivery system of the present disclosure loading the implant, where the actuation wire extends through the slit of the coupler;

[0031] FIG. 14 shows a schematic view of the delivery system of the present disclosure loading the implant, where one actuation wire is coupled to the mounting device;

[0032] FIG. 15 shows a schematic view of the delivery system of the present disclosure loading the implant, where two actuation wires are coupled to the mounting device;

[0033] FIG. 16 shows a schematic view of the delivery system of the present disclosure releasing the implant, where the quick loading assembly is separated from the proximal and distal ends of the implant;

[0034] FIG. 17 shows a schematic view of the delivery system of the present disclosure releasing the implant, where the actuation wire is separated from the engagement slot of the mounting device;

[0035] FIG. 18 shows a schematic view of the delivery system of the present disclosure releasing the implant, where the delivery system is completely separated from the implant. DETAILED DESCRIPTION

[0036] The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure. Obviously, the described embodiments are only part of the embodiments of the present disclosure, rather than all the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of the present disclosure.

[0037] The present application provides rapid loading assemblies, delivery systems, and repair systems for tissue approximation and repair at a treatment site. The rapid loading assemblies, delivery systems, and repair systems of the present application can be used in intravascular, minimally invasive, and open surgical procedures, and can be used in a variety of anatomical regions, including the abdomen, chest, cardiovascular system, heart, intestinal tract, stomach, urethra, bladder, lungs, and other organs, vessels, and tissues. The present application is particularly useful for minimally invasive or intravascular intervention at distal tissue locations where the instruments used must pass along long, narrow, and tortuous paths to reach the treatment site. In addition, many of the devices and systems of the present application can be reversible and can be removed from the patient at any point without interfering with or damaging the internal tissues.

[0038] According to some aspects of the present application, the rapid loading assemblies, delivery systems, and repair systems can be used for tissue fixation at a treatment site. Exemplary tissue fixation applications include heart valve repair, ventricular septal defect repair, vessel ligation and clipping, laceration repair, and wound closure, although the present application can be used in a wide variety of tissue approximation and repair procedures. In one embodiment, the rapid loading assemblies, delivery systems, and repair systems of the present application can be used to repair heart valves, particularly the mitral valve, as a treatment for regurgitation. The present application can utilize "edge-to-edge" or "bow-tie" techniques to coapt two or more leaflets to reduce regurgitation without the need for open heart surgery through the chest and heart wall as in conventional methods. Using the rapid loading assemblies, delivery systems, and repair systems of the present application, the mitral valve can be accessed from a remote surgical or vascular access point, and the two leaflets can be coapted using intravascular or minimally invasive methods. In some cases, the present application can also be applied in an open surgical procedure. According to some aspects of the present application, the mitral valve can be accessed from the atrial side (an antegrade approach) or the ventricular side (a retrograde approach), and can be accessed through a vessel or through the heart wall.

[0039] As used herein, "proximal" refers to the side closer to the operator of the procedure, and "distal" refers to the side closer to the target location of the procedure.

[0040] The repair system 10 of the present disclosure includes an implant 100 and a delivery system 20, the implant 100 being loadable into the delivery system 20 and deliverable to a target location via the delivery system 20. The implant 100 has a closed state and an open state. The implant 100 is in the closed state when the implant 100 is not subject to an external force. The implant 100 can be in the open state when the implant 100 is subject to an external force from the delivery system 20, and is adapted to clamp a human tissue. In some embodiments, the implant 100 is a valve clip, and the repair system 10 is a valve repair system.

[0041] Referring to FIG. 1, the implant 100 of the present disclosure includes a proximal connector 110, a distal clip holder 130, and two clips 150, each of which is attached to the connector 110 and the clip holder 130, respectively, and can move between an open position and a closed position. The implant 100 further includes two clamps 160, each of which has a fixed end and a free end, and the free end of each clamp is provided with a hole, and the fixed end of each clamp is rotatably connected to one of the clips, respectively. For example, the two clips are specifically a first clip and a second clip, and the two clamps are specifically a first clamp and a second clamp, the fixed end of the first clamp is rotatably connected to the first clip, and the fixed end of the second clamp is rotatably connected to the second clip. When the implant 100 is not subjected to external force, the clips 150 are in the closed position, and the implant 100 is in a closed state, as shown in FIGS. 8 and 9; when the clip holder 130 of the implant moves distally relative to the connector 110, the clips 150 open, and the implant 100 is in an open state, as shown in FIGS. 10 and 11.

[0042] Referring to FIGS. 3A, 8, the delivery system 20 of the present disclosure includes an actuation wire 230, which extends through the hole 162 of the free end of the clamp 160, thereby being attached to the clamp 160. Referring to FIGS. 10 and 11, when the implant 100 is in an open state, the clamp 160 can be pivoted relative to the ipsilateral clip 150 by moving the actuation wire, thereby causing the ipsilateral clip 150 and the clamp 160 to open and capture the leaflets.

[0043] Specifically, with continued reference to FIG. 1, the clamp 160 is configured to have a plate-shaped body and spikes provided on both sides of the plate-shaped body. In some embodiments, the hole 162 of the free end of the clamp 160 can be formed by a hole in the plate-shaped body; in other embodiments, it can be formed by a ring provided on the plate-shaped body. The clip 150 includes a clip body 156, which is configured to be an arc-shaped plate, one end of the clip body 156 being connected to the connector 110 and the other end being connected to the clip holder 130. Referring to FIG. 10, when the clamp 160 is not subjected to external force, the plate-shaped body of the clamp 160 is in close contact with the clip body 156.

[0044] More specifically, the connector 110 includes a tubular body having a central opening 114, and the outer periphery of the tubular body is provided with a protrusion 112. The delivery system 20 includes a coupler 240, and the protrusion 112 is adapted to cooperate with the coupler 240, which will be described later. In some embodiments, the clip 150 can be directly attached to the connector 110; in other embodiments, the clip 150 can be attached to the connector 110 through other components.

[0045] Continuing to refer to FIG. 1, specifically, in some embodiments, the implant 100 further comprises a coaptation element 120 and an intermediate hub 140, the connector 110 is connected to a proximal end of the coaptation element 120, the intermediate hub 140 is connected to a distal end of the coaptation element 120, and the clips 150 are attached to the connector 110 through the intermediate hub 140 and the coaptation element 120. Specifically, the coaptation element 120 is located between the two clips 150, and one of the clasp 160 is arranged between the clip 150 and the coaptation element 120, respectively. The coaptation element 120 is configured to be positioned within a native heart valve orifice to help fill the space and form a more effective seal, thereby reducing or preventing regurgitation. The coaptation element 120 can have a structure that is impermeable to blood and allows the native leaflets to close around the coaptation element 120 during ventricular contraction to prevent blood from flowing out of the left ventricle or right ventricle, respectively, back into the left atrium or right atrium. The implant 100 can be configured to seal against two or three native valve leaflets; that is, the implant can be used for native mitral and tricuspid valves.

[0046] Specifically, in some embodiments, the clip 150 comprises a clip body 156 and a U-shaped frame 152. The U-shaped frame 152 comprises two end portions 153, each of which is connected to the clip hub 130. The clip body 156 comprises a distal end 157 and a proximal end 158, the distal end 157 of the clip body is rotatably connected to the intermediate hub 140, and the proximal end 158 of the clip body is rotatably connected to the middle portion of the U-shaped frame 152. The delivery system 20 further comprises an actuation shaft 220 (inner shaft) extending through the connector 110, the coaptation element 120 and the intermediate hub 140, and detachably connected to the clip hub 130. The actuation shaft 220 is slidable relative to the connector 110, the coaptation element 120 and the intermediate hub 140. When the actuation shaft 220 is connected to the clip hub 130, the actuation shaft 220 can be moved to move the clip hub 130 distally relative to the connector 110, and the clip body 156 is opened laterally under the drive of the U-shaped frame 152, that is, the implant 100 is in an open state. Specifically, the actuation shaft 220 and the clip hub 130 are connected by threads. For example, the clip hub 130 is provided with internal threads, and the actuation shaft 220 is provided with external threads matched with the internal threads. Alternatively, the clip hub 130 of the implant 100 further comprises a guide shaft 132 extending towards the proximal end of the implant 100. The guide shaft 132 is provided to facilitate the connection of the actuation shaft 220 into the clip hub 130.

[0047] FIG. 2 illustrates components of a delivery system 20, which includes a rapid loading assembly 200, an intermediate catheter 300, and an outer catheter 400. The intermediate catheter 300 extends coaxially through the outer catheter 400, and the rapid loading assembly 200 extends coaxially through the outer catheter 400 and the intermediate catheter 300. Among other things, the outer catheter 400 and the intermediate catheter 300 can be used to access an implantation site (e.g., a native mitral valve region of a heart) and / or position the rapid loading assembly 200 at the implantation site. Specifically, the outer catheter 400 includes a first sheath 402, which can be configured to steer; the intermediate catheter 300 includes a second sheath 302, which can be configured to steer; and the rapid loading assembly 200 includes an outer shaft 202. The second sheath 302 extends coaxially through the first sheath 402, and the outer shaft 202 extends coaxially through the first sheath 402 and the second sheath 302. The rapid loading assembly 200 can be used to deliver, manipulate, position, and / or deploy an implant 100 at the implantation site. Alternatively, in some embodiments, the delivery system 20 can include only the rapid loading assembly 200 and the first sheath 402.

[0048] Referring to FIGS. 2, 3A, 3B, and 3C, specifically, the rapid loading assembly 200 includes an outer shaft 202, a handle 204 (shown schematically), a hanger 210, an actuation shaft 220, and an actuation wire 230. A proximal end portion of the outer shaft 202 is coupled to the handle 204, and a distal end portion of the outer shaft 202 is coupled to the hanger 210. A proximal end portion of the actuation shaft 220 can be coupled to the handle 204, e.g., to an actuation knob of the handle. The actuation shaft 220 can extend distally from the actuation knob, in turn through the handle 204, the outer shaft 202, and a coupler 240. The actuation shaft 220 can be movable (e.g., axially and / or rotationally) relative to the outer shaft 202 and the handle 204. A proximal end portion of the actuation wire 230 can be coupled to the handle 204, and the actuation wire 230 can extend through the handle 204 and the outer shaft 202 and be axially movable relative to the handle 204 and the outer shaft 202. In addition, the actuation wire 230 can also be axially movable relative to the actuation shaft 220. A distal end portion of the actuation wire 230 can be coupled to the hanger 210. The coupling of the actuation wire 230 to the hanger 210 via the distal end portion enables the actuation wire 230 to releasably connect to the implant 100.

[0049] In particular, referring to FIG. 3C, the actuation wire 230 includes an elongated body portion 232 and a protrusion 234 at a distal end of the body portion 232. The body portion 232 can take a variety of forms, such as a suture, a wire, a rod, a tube, etc. The protrusion 234 can be any structure that has a larger cross-section than the body portion 232, and is preferably a three-dimensional structure with a smooth outer wall, such as a water droplet, a sphere, a cone, etc. In some embodiments, the body portion 232 and the protrusion 234 can be fixedly connected by adhesion, welding, knotting, etc. In other embodiments, the body portion 232 and the protrusion 234 can be integrally formed. Alternatively, a wire can be used as the body portion 232, and the protrusion 234 can be formed by shaping the wire with a tool, such as by adding additional meltable material to the tool or by melting the wire directly. Alternatively, the actuation wire 230 can be initially shaped, and then ground or polished to the desired shape. Preferably, the protrusion 234 is shaped as a cone, and the body portion 232 of the actuation wire 230 is connected to the smaller end of the protrusion 234.

[0050] Referring to FIGS. 4-6, the mount 210 is provided with an engagement slot 212 that couples with the actuation wire 230. In particular, the mount 210 includes a tubular body portion, and the engagement slot 212 is provided in the body portion of the mount 210, with the actuation shaft 220 extending through the body portion of the mount 210. The engagement slot 212 includes a narrow portion 212a and at least two enlarged portions 212b, with the narrow portion 212a in communication with each of the enlarged portions 212b. The narrow portion 212a is configured to allow the body portion 232 of the actuation wire 230 to pass therethrough while restricting the passage of the protrusion 234, and the enlarged portions 212b are configured to allow the protrusion 234 of the actuation wire 230 to pass therethrough. When the actuation wire 230 extends through the two enlarged portions 212b, with the protrusion 234 in one of the two enlarged portions 212b, and the actuation shaft 220 is positioned within the mount 210, the actuation shaft 220 can restrict the movement of the protrusion 234, thereby preventing the protrusion 234 from entering the mount 210. In particular, the body portion 232 of the actuation wire 230 can be passed through the engagement slot 212 to extend through the two enlarged portions 212b.

[0051] In some embodiments, the engagement slot 212 includes two enlarged portions 212b, with the two enlarged portions 212b provided at opposite ends of the narrow portion 212a. In some embodiments, the engagement slot 212 includes three or more enlarged portions 212b. For example, the engagement slot 212 can include three enlarged portions 212b, with an enlarged portion 212b provided at each of the two ends and the middle of the narrow portion 212a, so that the two most appropriate enlarged portions 212b can be selected to couple with the actuation wire 230 when the rapid loading assembly 200 is loaded with the implant 100, such as by considering the forces, by facilitating the arrangement of the actuation wire 230, etc.

[0052] The following describes the case of providing two enlarged portions 212b in the engagement groove 212. Specifically, in some embodiments, the two enlarged portions 212b of the engagement groove 212 are distributed at an angle along the radial direction, for example, 90°, 120°, 150°, 180°, 210°, etc. Preferably, the two enlarged portions 212b of the engagement groove 212 are distributed at 180° along the radial direction. In this arrangement, it is beneficial for the protrusion 234 of the actuating wire 230 to pass through the two enlarged portions 212b after the actuating shaft 220 is withdrawn from the mount 210. In some embodiments, in order to avoid the main body portion 232 of the actuating wire 230 from disengaging from the engagement groove 212, the narrow portion 212a of the engagement groove 212 has different longitudinal heights. For example, the narrow portion 212a is configured as a wavy line, a zigzag line, or the like extending along the circumferential direction. In particular, referring to FIGS. 4-6, the narrow portion 212a is configured as a U-shape, which includes a transverse segment and longitudinal segments on both sides of the transverse segment. The transverse segment extends along the circumferential direction of the main body portion of the mount. More particularly, referring to FIG. 5, the narrow portion 212a of the engagement groove 212 is connected to one side of the enlarged portion 212b (rather than the narrow portion 212a being aligned with the center of the enlarged portion 212b), and the portion of the main body portion of the mount 210 that limits the enlarged portion 212b forms a step 214. Preferably, the step 214 is located on the inner side of the U-shaped narrow portion 212a. When the protrusion 234 is located in the enlarged portion 212b where the step 214 is provided, the contact between the actuating wire 230 and the step 214 can increase the friction, which is beneficial for limiting the movement of the actuating wire 230 so as to prevent the main body portion 232 from disengaging from the narrow portion 212a.

[0053] Continuing to refer to FIG. 3A, FIG. 8, the quick loading assembly 200 is provided with two actuating wires 230, each of which is coupled to one of the clasp halves 160, so that each of the clasp halves 160 can be independently manipulated. Referring to FIG. 4 to FIG. 6, the hanger 210 is provided with two engagement slots 212, which are longitudinally distributed. In particular, in some embodiments, the narrow sections 212a of the two engagement slots 212 are located at opposite sides of the hanger 210, respectively. Continuing to refer to FIG. 5, preferably, the enlarged sections 212b are located at distal ends of the longitudinal sections of the narrow sections, and the transverse sections are located at proximal ends of the longitudinal sections of the narrow sections. When the actuating wires 230 are coupled to the clasp halves 160, the main body portions 232 and the protrusions 234 thereof are subjected to pulling force towards the distal ends. By locating the enlarged sections 212b at the distal ends of the longitudinal sections, the protrusions 234 are abutted against the side walls defining the enlarged sections 212b under the pulling force, and the protrusions 234 are reliably clamped by the cooperation of the actuating shaft 220, so that the actuating wires 230 are not easily slipped out of the enlarged sections 212b. In addition, when the actuating shaft 220 is withdrawn, the enlarged sections 212b located at the distal ends of the longitudinal sections are more conducive to the protrusions 234 to sequentially pass through the two enlarged sections 212b under the pulling force, and then to be detached from the hanger 210. Referring to FIG. 6, alternatively, the enlarged sections 212b can also be located at the proximal ends of the longitudinal sections of the narrow sections, and the transverse sections are located at the distal ends of the longitudinal sections of the narrow sections.

[0054] Continuing to refer to FIG. 8, FIG. 9, the clasp halves 160 of the implant 100 are provided with holes, through which the main body portions 232 and the protrusions 234 of the actuating wires 230 can pass. The proximal ends of the actuating wires 230 are located at the handle 204, and the distal ends pass through the holes 162 of the clasp halves and are coupled to the hanger 210 through the protrusions 234. Under the action of no external force, the clasp halves 160 are close to the clip bodies 156. Referring to FIG. 10, FIG. 11, when the implant 100 is in an open state, the clip bodies 156 are opened outwardly, and the clasp halves can be pivoted inwardly relative to the clip halves 150 on the same side by pulling the actuating wires 230, so that the clasp halves 150 and the clasp halves 160 on the same side are opened. When the quick loading assembly 200 is manipulated to be separated from the implant 100, the actuating shaft 220 is withdrawn from the hanger 210, and the protrusions 234 pass through the two enlarged sections 212b of the engagement slots 212, so that the actuating wires 230 are separated from the hanger 210, and then the actuating wires 230 are separated from the clasp halves 160.

[0055] Alternatively, the actuation wire 230 includes a body portion 232 and an expandable portion at the distal end of the body portion 232, the expandable portion having a contracted configuration and an expanded configuration. When the actuation wire 230 needs to be coupled with the hanger 210, the expandable portion is in the expanded configuration, and the actuation shaft 220 restricts the expandable portion from passing through the limiting slot. When the rapid loading assembly 200 is separated from the implant 100, the actuation shaft 220 is withdrawn from the hanger 210, the expandable portion switches to the contracted configuration, and the expandable portion can pass through the engagement slot 212 of the hanger 210 smoothly, thereby achieving the separation of the actuation wire 230 from the hanger 210. Specifically, the expandable portion of the actuation wire 230 is configured to form the expanded configuration under the action of an external force and to form the contracted configuration when not subjected to the external force. More specifically, in some embodiments, the expandable portion is configured to have a structure similar to a hollow balloon.

[0056] Referring to FIGS. 7A and 7B, details of the cooperation between the actuation wire 230 and the actuation shaft 220 are shown. In FIG. 7A, the actuation shaft 220 is first extended through the hanger 210, and then the body portion 232 of the actuation wire is clamped into the narrow portion 212a of the engagement slot 212, and then the actuation wire 230 is pulled back slightly so that the protrusion 234 is located in an enlarged portion 212b. The actuation shaft 220 is loaded first and then the actuation wire 230 is loaded, so that the body portion 232 of the actuation wire is located on the lateral side of the actuation shaft 220 and close to the narrow portion of the engagement slot 212 that cooperates with the actuation wire. When the actuation shaft 220 moves distally relative to the hanger 210, the actuation wire 230 is kept stationary by the side wall of the enlarged portion 212b. When the actuation shaft 220 moves proximally relative to the hanger 210 again, the portion of the actuation wire 230 in contact with the actuation shaft 220 has a tendency to move proximally, but the actuation wire 230 is limited by the step 214, and the body portion 232 of the actuation wire is prevented from sliding into the narrow portion 212a of the engagement slot, so that the actuation wire 230 continues to be clamped.

[0057] Alternatively, the body portion 232 of the actuation wire can be first snapped into the narrow portion 212a of the engagement slot 212, and then the actuation shaft 220 is extended through the mount 210 to secure the actuation wire. In particular, referring to FIG. 7B, the actuation wire 230 is loaded first and the actuation shaft 220 is loaded second, such that the body portion 232 of the actuation wire is positioned on the lateral side of the actuation shaft 220 and away from the narrow portion of the engagement slot 212 that mates with the actuation wire. At this point, the body portion 232 proximal to the protrusion 234 is completely isolated from the lateral segment of the narrow portion 212a of the engagement slot 212 that mates with the actuation wire, such that the actuation wire 230 is completely and securely locked. When the actuation shaft 220 is moved distally relative to the mount 210, the actuation wire 230 is held in place by the sidewall of the enlarged portion 212b. When the actuation shaft 220 is moved proximally relative to the mount 210 again, the portion of the actuation wire 230 in contact with the actuation shaft 220 has a tendency to move proximally, and the actuation wire 230 can slide out of the enlarged portion 212b into the longitudinal segment of the narrow portion under the actuation shaft 220. However, the body portion 232 proximal to the protrusion 234 is isolated from the lateral segment of the narrow portion 212a of the engagement slot 212 that mates with the actuation wire, such that the actuation wire 230 continues to be securely locked.

[0058] With continued reference to FIGS. 3A, 3B, and 3C, in particular, the rapid loading assembly 200 further includes a coupler 240 coupled to a distal portion of the outer shaft 202, with the mount 210 disposed on an inner side of the coupler 240, and the coupler 240 releasably connectable to the implant 100. In particular, the coupler 240 can be releasably coupled to the proximal connector 110 of the implant 100. For example, in some embodiments, the coupler 240 can include a plurality of flexible arms 244, such as two flexible arms 244. The flexible arms 244 include a flexible arm body, a connection slot 246 disposed on the flexible arm body, and a locking ring 248 disposed on an inner side of the flexible arm body. The flexible arms 244 can be configured to pivot between a release configuration and a coupled configuration. In the release configuration, the flexible arms 244 extend radially outward, as shown in FIGS. 3B and 3C. In the coupled configuration, the flexible arms 244 extend axially parallel to an axis of the coupler 240, and the two locking rings 248 radially overlap (coaxially disposed), as shown in FIG. 3A. The connection slot 246 is configured to engage with the protrusion 112 disposed on the connector 110, and the rapid loading assembly 200 is coupled to the proximal end of the implant 100 via the connection slot 246 when the actuation shaft 220 is extended through the locking rings 248 to place the flexible arms 244 in the coupled configuration. When the actuation shaft 220 is withdrawn from within the coupler 240, the flexible arms 244 pivot to the release configuration, and the connection slot 246 is disengaged from the protrusion 112 of the connector 110, thereby enabling the rapid loading assembly 200 to be decoupled from the proximal end of the implant 100.

[0059] Alternatively, in some embodiments, the coupler 240 is configured as a tab with a tendency to contract inwards, and the connecting member 110 is provided with a coupling groove that cooperates with the tab. When the actuating shaft 220 is extended through the coupler 240 to couple the tab with the coupling groove of the connecting member 110, the rapid loading assembly 200 is coupled to the proximal end of the implant 100; when the actuating shaft 220 is withdrawn from the coupler 240, the tab of the coupler 240 contracts inwards, and the tab is separated from the coupling groove of the connecting member 110, thereby achieving the separation of the rapid loading assembly 200 from the proximal end of the implant 100.

[0060] The following will continue to be exemplarily described by taking the flexible arms 244 of the coupler 240 as an example. Referring to FIGS. 3A, 8, and 9, the hanger 210 is coaxially arranged with the coupler 240, and the hanger 210 is located inwards of the proximal end of the coupler 240. The actuating shaft 220 is sequentially extended through the hanger 210, the locking ring 248 of the coupler 240, and the connecting member 110, i.e., the locking ring 248 is located at the distal end of the hanger. When the flexible arms 244 are in the coupled configuration, there is a gap between the two flexible arms 244 in the circumferential direction. Preferably, the gap between the enlarged portion 212b of the engagement groove 212 on the hanger 210 and the flexible arms 244 is aligned, which facilitates the connection of the actuating wire 230 to the hanger 210, and in addition, when the flexible arms 244 are opened outwards in the expanded configuration, the actuating wire 230 can be prevented from interfering with or interfering with the flexible arms 244. More preferably, the central axis of the enlarged portion 212b is perpendicular to the expansion direction of the flexible arms 244, so that the actuating wire 230 is maximally kept away from the flexible arms 244.

[0061] In some embodiments, referring to FIG. 9, the proximal end of the coupler 240 is provided with a limiting groove 242, and the limiting groove 242 cooperates with the distal end of the outer shaft 202 to form a limiting hole. The main body portion 232 of the actuating wire can extend through the limiting hole into the outer shaft 202, and the limiting hole can limit the retraction of the protrusion 234 of the actuating wire into the outer shaft 202. In particular, the gap between the limiting groove 242 and the flexible arms 244 is aligned. Alternatively, the limiting hole can be directly formed at the proximal end of the coupler 240, or the limiting hole can be directly formed at the distal end of the outer shaft 202.

[0062] The application also discloses a method for loading the implant using the quick loading assembly 200. Referring to FIG. 12, the connector 110 of the implant 100 is connected with the coupler 240 of the quick loading assembly 200, and an external force is applied to the flexible arm to make the convex part 112 of the connector 110 located in the connecting groove 246 of the coupler 240. Then the actuating shaft 220 is controlled to move distally, and the actuating shaft 220 extends out of the outer shaft 202, sequentially extends through the hanger 210, the locking ring 248 of the coupler 240, the connector 110 of the implant 100, the opposing element 120, the intermediate seat 140, and enters the clamping seat 130. Then the actuating shaft 220 is controlled to rotate in the first direction to make the external thread located at the distal side of the actuating shaft 220 combined with the internal thread of the clamping seat 130. At this time, the quick loading assembly 200 is coupled with the connector 110 and the clamping seat 130 of the implant 100, that is, the quick loading assembly 200 is connected with the proximal end and the distal end of the implant 100. Alternatively, the actuating shaft is controlled to move distally to make the clamping body 156 of the implant 100 rotate outward to open, which is convenient for subsequent loading arrangement.

[0063] Referring to FIG. 13, the distal end of the actuating wire 230 is inserted through the hole 162 of the buckle 160, and then the actuating wire extends through the gap of the coupler. Referring to FIG. 14, the body part 232 of one actuating wire 230 is clamped into the narrow part 212a of the engaging groove 212, and then the actuating wire 230 is pulled back to make the protrusion 234 located in the enlarged part 212b. At this time, the actuating wire 230 is coupled with the hanger 210, the distal end of the body part 232 of the actuating wire 230 extends into the hanger 210 from the other enlarged part 212b, and the protrusion 234 is limited by the actuating shaft 220 and cannot enter the hanger 210. Referring to FIG. 15, another actuating wire 230 is connected to the engaging groove 212 according to the foregoing method. Referring to FIG. 7A, the actuating wire 230 is located on one side of the actuating shaft 220, and the side is close to the engaging groove 212 matched with the actuating wire 230. The actuating wire 230 is in contact with the step 214 to increase the friction, so that the actuating wire 230 is firmly locked and avoids moving away from the narrow part 212a. The actuating shaft is controlled to move proximally to make the clamp closed and adjusted to the sheathing state. When the actuating wire is connected to the hanger 210, the actuating wire 230 can be held by tweezers for operation.

[0064] Alternatively, in some embodiments, when loading the implant using the rapid loading assembly 200, the actuation wire 230 can be coupled to the hanger 210 first, and then the actuation shaft 220 is manipulated to extend through the hanger 210, the locking ring 248 of the coupler 240, the connector 110 of the implant 100, the opposing element 120, the intermediate seat 140, and finally into the clamping seat 130 and lock with it. When the actuation shaft 220 extends through the hanger 210, the actuation wire 230 is then pulled tight so that the protrusion 234 contacts the engagement groove 212, for example, so that the protrusion 234 is located in an enlarged portion. The actuation wire 230 can be located on one side of the actuation shaft 220, which is the side close to the engagement groove 212 that cooperates with the actuation wire 230; see FIG. 7B, the actuation wire 230 can also be located on the other side of the actuation shaft 220, which is the side away from the engagement groove 212 that cooperates with the actuation wire 230. In particular, in some embodiments, the actuation wire 230 is located on the other side of the actuation shaft 220, and the main body portion 232 of the actuation wire 230 is completely isolated from the transverse section of the narrow portion 212a of the cooperating engagement groove 212, so that the actuation wire 230 is completely locked. During loading, a tooling device or the like can be used to position the actuation wire 230 on the target side of the actuation shaft 220.

[0065] Through the above steps or operations, the implant can be rapidly loaded into the rapid loading assembly 200. When it is necessary to separate the implant and the rapid loading assembly 200, the actuation shaft 220 is manipulated to rotate in the second direction so that the external thread distal to the actuation shaft 220 is separated from the internal thread of the clamping seat 130, and the rapid loading assembly 200 is separated from the distal end of the implant. Then the actuation shaft 220 is manipulated to move proximally, so that the actuation shaft 220 is withdrawn from the locking ring 248. The flexible arm 244 opens outward, and the connecting groove 246 of the coupler is separated from the convex portion 112 of the implant, and the rapid loading assembly 200 is separated from the proximal end of the implant, as shown in FIG. 16. Continue to manipulate the actuation shaft 220 to move proximally, so that the actuation shaft 220 is withdrawn from the hanger 210. Pull the actuation wire 230 to move proximally, and the protrusion 234 enters the hanger 210 from the enlarged portion 212b where it is located, and exits the hanger 210 through another enlarged portion 212b, and the actuation wire 230 is separated from the hanger 210, as shown in FIG. 17. Continue to pull the actuation wire 230 to move proximally, and the actuation wire 230 is separated from the buckle 160, i.e., the rapid loading assembly 200 is separated from the buckle of the implant. At this time, the rapid loading assembly 200 is completely separated from the implant, as shown in FIG. 18. The protrusion 234 of the actuation wire is limited by the limiting groove 242 of the coupler and cannot move proximally, facilitating the loading of a new implant again.

[0066] In use, the implant can be loaded into the rapid loading assembly 200 after packaging for surgical treatment; or the implant can be packaged and stored separately from the rapid loading assembly 200, and when surgery is needed, the implant is loaded into the rapid loading assembly 200. Using the rapid loading assembly 200 and the delivery system comprising the same of the present disclosure, multiple implants can be repeatedly loaded according to the needs of surgery. For example, when two implants need to be placed in the target position of the human body, the first implant can be delivered to the target position of the human body by using the rapid loading assembly 200 to load the first implant, and then the rapid loading assembly 200 is reused to load the second implant for delivery to the human body. Alternatively, when the implant loaded into the rapid loading assembly 200 is damaged or not suitable in size, the implant can be removed from the rapid loading assembly 200 and a new implant can be quickly replaced. In addition, when the rapid loading assembly 200 is damaged, the implant can be used with a new rapid loading assembly 200.

[0067] Using the rapid loading assembly, system and method of the present disclosure, the implant can be quickly loaded into the rapid loading assembly during surgery, which is convenient to operate and efficient. In addition, only 1-2 sets of delivery systems and multiple implants need to be prepared during surgery, which can greatly reduce the number of products needed during surgery, and reduce the cost of inventory and products.

[0068] The above only describes several embodiments of the present disclosure, and those skilled in the art can make various modifications or changes to the embodiments of the present disclosure according to the content disclosed in the application file without departing from the spirit and scope of the present disclosure.

Claims

1. A rapid loading assembly for loading an implant, the rapid loading assembly comprising: an outer shaft; a hanger connected to a distal end of the outer shaft; an actuation shaft extending through the outer shaft and the hanger, releasably connected to the implant; and an actuation wire comprising an elongated body portion and a protrusion at a distal end of the body portion, the actuation wire releasably connected to the implant; wherein the hanger is provided with an engagement slot coupled with the actuation wire, the engagement slot comprising a narrow portion and at least two enlarged portions in communication with the narrow portion, the narrow portion of the engagement slot configured to allow the body portion of the actuation wire to pass therethrough while restricting the protrusion of the actuation wire to pass therethrough, the enlarged portions of the engagement slot configured to allow the protrusion of the actuation wire to pass therethrough; wherein the actuation shaft restricts the protrusion from moving when the actuation shaft is located within the hanger, the actuation wire extends through the two enlarged portions, and the protrusion is located in one of the two enlarged portions. The narrow portion of the engagement slot has different longitudinal heights.

2. The quick load assembly of claim 1, wherein, The enlarged portions are configured to be two, one enlarged portion is arranged at each end of the narrow portion, and the narrow portion of the engagement slot is configured to be U-shaped in the longitudinal direction.

3. The quick load assembly of claim 2, wherein, The two enlarged portions are distributed along a radial direction by 180°.

4. The quick load assembly of claim 3, wherein, The hanger is provided with two engagement slots, the two engagement slots are distributed along the longitudinal direction, and the narrow portions of the two engagement slots are located at opposite sides of the hanger, respectively.

5. The quick load assembly of claim 4, wherein, The narrow portion of each engagement slot comprises a transverse segment and longitudinal segments at both ends of the transverse segment, the transverse segment is located at a proximal end of the two longitudinal segments, and the two enlarged portions are located at distal ends of the two longitudinal segments, respectively.

6. The quick load assembly of claim 5, wherein, The protrusion of the actuation wire is configured to be a cone, and the body portion of the actuation wire is connected to a small cross-section end of the protrusion.

7. The quick load assembly of claim 1, wherein, The rapid loading assembly further comprises a coupler connected to a distal end of the outer shaft, the hanger is arranged inside a proximal end of the coupler, the actuation shaft can extend through the coupler, and the coupler is releasably connected to a proximal end of the implant.

8. The quick load assembly of any one of claims 1-7, wherein, A limiting slot is arranged at a proximal end of the coupler to restrict the protrusion of the actuation wire from passing therethrough.

9. The quick load assembly of claim 8, wherein, The coupler comprises a plurality of flexible arms, a connecting slot is arranged at a distal end of each flexible arm, a locking ring is arranged at an inner side of each flexible arm, and the connecting slot engages the proximal end of the implant to connect the implant to the coupler when the actuation shaft extends through the locking ring.

10. The quick load assembly of claim 9, wherein, The flexible arms are configured to be two, the two flexible arms are arranged oppositely, the locking ring is located at a distal end of the hanger, and the enlarged portions of the engagement slot are aligned with gaps between the two flexible arms.

11. The quick load assembly of claim 10, wherein, 12. A valve repair system comprising a valve clip and a delivery system; the valve clip comprising: a proximal connector and a distal clip holder; a first clip piece and a second clip piece, each clip piece attached to the clip holder and the connector, respectively; a first clasp and a second clasp, each clasp having a fixed end and a free end, the free end of each clasp being provided with a hole, the fixed end of the first clasp being connected to the first clip piece, and the fixed end of the second clasp being connected to the second clip piece; the delivery system comprising the rapid loading assembly of any one of claims 1-11. the delivery system further comprising an outer catheter and an intermediate catheter; 13. The valve repair system of claim 12, wherein, ​ The outer catheter includes a first sheath, the outer catheter can be configured to deflect the first sheath; The intermediate catheter includes a second sheath, the intermediate catheter can be configured to deflect the second sheath; Wherein the second sheath extends coaxially through the first sheath, and the outer shaft extends coaxially through the first sheath and the second sheath.

14. A method of loading a valve clip using the quick loading assembly of any one of claims 8-11, the method comprising the steps of: connecting a connector of the valve clip to the coupler, operating the actuating shaft to extend through the outer shaft and the coupler, and coupling the coupler to the connector; threadably locking the distal end of the actuating shaft to the clip holder; and threading the actuating wire through the aperture of the catch and placing a portion of the body of the actuating wire in the retaining slot of the hanger, and tensioning the actuating wire such that the protrusion is positioned in the enlarged portion.

15. A method of loading a valve clip using the quick loading assembly of any one of claims 8-11, the method comprising the steps of: threading the actuating wire through the aperture of the catch and placing a portion of the body of the actuating wire in the retaining slot of the hanger; connecting a connector of the valve clip to the coupler, operating the actuating shaft to extend through the outer shaft, the hanger, and the coupler, and coupling the coupler to the connector; and the distal end of the actuation shaft is threadably locked with the clamp holder, wherein the actuating wire is positioned on the lateral side of the actuating shaft and distal to the narrow portion of the engagement slot that cooperates with the actuating wire.

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