CN119925038A

CN119925038A - Sheath Assemblies and Delivery Systems for Manipulating Implants

Info

Publication number: CN119925038A
Application number: CN202411650916.1A
Authority: CN
Inventors: 李培尚; 张姣姣; 朱灵珂; 秦华北; 黄广念; 方洋飞; 蔡江华; 吕守良
Original assignee: Minder Medical Technology Group Co ltd
Current assignee: Minder Medical Technology Group Co ltd
Priority date: 2024-11-19
Filing date: 2024-11-19
Publication date: 2025-05-06
Anticipated expiration: 2044-11-19
Also published as: CN119925038B

Abstract

The present invention provides a sheath assembly for manipulating an implant in a heart valve repair system and a delivery system comprising the sheath assembly. The sheath assembly includes a handle housing, a multi-lumen tube, an actuation wire, and an actuation wire control mechanism. The actuation wire includes a single row of body segments extending through the multi-lumen tube and a return segment adjacent a proximal side of the body segments. The actuation wire control mechanism includes a push-pull member axially movable relative to the handle housing, the push-pull member being coupled to the return section, axial movement of the push-pull member moving the tabs of the implant between an open configuration and a closed configuration. Wherein when the push-pull member is axially moved, the actuator wire is retracted or advanced a greater distance than the push-pull member is axially moved. The invention does not need to draw out the whole control line of the valve clamp when releasing the valve clamp, effectively shortens the operation time and lays a foundation for the secondary use of the conveying system.

Description

Sheath assembly and delivery system for manipulating implants

Technical Field

The invention relates to the field of interventional medical instruments, in particular to a sheath tube assembly and a delivery system for manipulating an implant in a heart valve repair system.

Background

The existing heart valve repair clips are all in a preassembled design, and the clips and the delivery system are assembled when leaving the factory. One set of conveying system is matched with one clamp, when a plurality of clamps or apparatuses are required to be implanted in the operation process to fail, the whole set of system and the clamps are required to be replaced, and the conveying system or the clamps cannot be independently replaced, so that a plurality of sets of apparatuses with different specifications and models are required to be prepared for standby in the operation process, and the stock and transportation cost of products is increased. In addition, related products on the market today generally require a withdrawal of a line through the entire delivery system during the valve clip release phase, which increases both the surgical time and the risk of blood leakage.

Disclosure of Invention

To address the above problems, the present invention provides a sheath assembly and delivery system for manipulating an implant.

In one aspect, a sheath assembly for manipulating an implant includes a handle housing, a multi-lumen tube, an actuation wire, and an actuation wire control mechanism. The multi-lumen tube extends distally from the handle housing, a proximal end of an actuation wire is coupled to the handle housing, a distal end of the actuation wire is coupled to the blade of the implant, and the actuation wire includes a single row of body segments extending through the multi-lumen tube and a return segment adjacent a proximal side of the body segments. The actuation wire control mechanism includes a push-pull member axially movable relative to the handle housing, the push-pull member being coupled to the return section, axial movement of the push-pull member moving the tabs of the implant between an open configuration and a closed configuration. Wherein when the push-pull member is axially moved, the actuator wire is retracted or advanced a greater distance than the push-pull member is axially moved.

Further, the proximal end of the actuation wire may be releasably secured to the handle housing, and when the proximal end of the actuation wire is released from the handle housing, the actuation wire may continue to move proximally a defined distance to separate the distal end of the actuation wire from the cleat of the implant.

Further, the actuating wire control mechanism further comprises a pushing sliding rail, and the pushing sliding rail is axially arranged in the handle shell and fixed relative to the handle shell. The actuation wires are configured as a pair, in particular a first actuation wire and a second actuation wire. The push-pull component comprises a first push seat, a second push seat, a first push button and a second push button, wherein the first push button is connected with the first push seat, the second push button is connected with the second push seat, and the first push button and the second push button are respectively attached to the push sliding rail in an axially movable manner. The first pushing seat and the second pushing seat extend along the axial direction, a first connecting part is arranged on the first pushing seat, a second connecting part is arranged on the second pushing seat, the turning-back section of the first actuating wire and the turning-back section of the second actuating wire are respectively configured to comprise one-time turning-back, the proximal end of the turning-back section of the first actuating wire is attached to the first connecting part, and the proximal end of the turning-back section of the second actuating wire is attached to the second connecting part. The first push button is configured to move axially relative to the push slide rail to drive the first push seat to move axially, and the second push button is configured to move axially relative to the push slide rail to drive the second push seat to move axially.

Specifically, the first push button is coupled to a proximal end of the first push seat, which is provided with an engagement groove. The second push button is coupled to the proximal end of the second push seat, and the proximal end of the second push seat is provided with an engagement hole in which a coupling shaft which can move relative to the axis direction of the engagement hole but cannot rotate is arranged. The second push button is provided with a driving shaft extending radially inwards of the handle housing, the driving shaft is coupled to the handle housing and rotatably penetrates the linkage shaft, and the positions of the driving shaft and the handle housing in the radial direction are relatively fixed. When the engagement groove of the first pushing seat is aligned with the engagement hole of the second pushing seat, rotating the second pushing button can drive the linkage shaft to radially translate into or out of the engagement groove. When at least a part of the linkage shaft enters the engagement groove, the first push button and the second push button can be axially moved synchronously by axially pulling either one of the first push seat and the second push seat.

Further, a first limiting part is arranged on the far side of the pushing slide rail, a second limiting part is arranged on the near side of the pushing slide rail, the first pushing button and the second pushing button are respectively provided with a first stopping position and a second stopping position, and the first limiting part and the second limiting part enable the first pushing button and/or the second pushing button to axially move between the first stopping position and the second stopping position. And a third limiting part capable of releasing limiting is arranged at the axial position between the first limiting part and the second limiting part. The third limiting part can limit the first push button or the second push button to move proximally when the first push button or the second push button is positioned at the first stop position, and limit the first push button or the second push button to move distally when the first push button or the second push button is positioned at the second stop position.

Preferably, the third limit portion is configured as a push-to-spring self-locking mechanism including a button, a dial, a chute mechanism, a spring, a telescopic rod, and a stop catch. The sliding groove mechanism is fixed relative to the handle shell and extends along the pressing direction of the button, the button and the rotary disc are arranged along the pressing direction and are both coupled to the sliding groove mechanism, and one side of the button away from the rotary disc protrudes out of the sliding groove mechanism for receiving pressing. One end of the spring is abutted to the turntable, and the other end of the spring is abutted to the pushing sliding rail. One end of the telescopic rod is connected with the turntable, and the other end of the telescopic rod is connected with the stop block. The sliding groove mechanism is provided with a long locking groove and a short locking groove, and the turntable is alternately coupled with the long locking groove and the short locking groove by pressing the button. When the button is in a pressed state, the turntable is coupled with the short locking groove to enable the telescopic rod to extend towards the pressing direction of the button, and the stop block blocks the axial movement of the push button. When the button is in a sprung state, the turntable is coupled with the long locking groove to enable the telescopic rod to retract towards the sprung direction of the button, and the stop block piece does not block the axial movement of the push button.

Further, the sheath assembly further comprises a sheath fixing seat, a first actuating wire withdrawing assembly and a second actuating wire withdrawing assembly. The sheath pipe fixing seat is arranged in the handle shell and is fixed relative to the handle shell, the distal end of the sheath pipe fixing seat is close to the distal end of the handle shell, and the proximal end of the sheath pipe fixing seat is close to the distal end of the pushing sliding rail. The sheath tube fixing seat is provided with a longitudinally extending inner cavity, and the first pushing seat and the second pushing seat can axially move and extend in the inner cavity of the sheath tube fixing seat. The first and second actuation wire retraction assemblies are releasably secured to laterally opposite sides of the handle housing and are each proximate the distal end of the sheath mount, the return sections of the first and second actuation wires each extending through the lumen of the sheath mount, the proximal end of the first actuation wire being coupled to the first actuation wire retraction assembly, and the proximal end of the second actuation wire being coupled to the second actuation wire retraction assembly. Wherein when the first or second actuation wire retraction assembly is unsecured from the handle housing, the actuation wire may continue to move proximally to disengage the distal end of the actuation wire from the blade of the implant.

Specifically, the first and second actuation wire retraction assemblies are each configured to include a retraction mount, a seal end cap, a retraction rod, and a retraction rod cap. One end of the back-out fixing seat is positioned on the inner side of the handle shell and is coupled with the sheath tube fixing seat, the other end of the back-out fixing seat is positioned on the outer side of the handle shell, the sealing end cover is coupled to the back-out fixing seat from the outer side of the handle shell, and the back-out rod cap is detachably coupled to the sealing end cover. The back-out fixing seat is provided with an inner cavity extending along the transverse direction of the handle, one end of the back-out rod extends into the inner cavity of the back-out fixing seat, the other end of the back-out rod extends to be fixedly connected with the back-out rod cap, and the proximal end of the actuating wire is fixedly connected to the back-out rod. The back-out fixing seat and the sealing end cover are fixed relative to the handle shell, and when the back-out rod cap is uncoupled from the sealing end cover, the back-out rod can be driven to be far away from the sheath tube fixing seat, so that the proximal end of the actuating wire is driven to be far away from the handle shell. Further, the pull-back rod and the sealing end cover are provided with mutually matched limiting mechanisms, and when the pull-back rod is far away from the sheath tube fixing seat, the limiting mechanisms limit the moving distance of the pull-back rod.

Further, the sheath assembly also includes an actuation shaft extending from the interior of the handle housing through the lumen of the sheath mount and through the multi-lumen tube, and a control knob, the distal end of the actuation shaft being coupled to the implant. A control knob is located at the proximal end of the push rail, the control knob coupled to the actuation shaft, the control knob rotatable relative to the handle housing, wherein rotation of the control knob axially moves the actuation shaft relative to the handle housing and the multi-lumen tube. The proximal end of the sheath tube fixing seat is provided with a first group of sealing structures which can seal the inner cavity, the actuating shaft, the first pushing seat and the second pushing seat of the sheath tube fixing seat. A second group of sealing structures are arranged between the sheath tube fixing seat and the back-out fixing seat and between the back-out fixing seat and the back-out rod.

Further, the first pushing seat and the second pushing seat each comprise a large end portion at a proximal end and an axial length portion extending from the large end portion to a distal end, the large end portion is coupled with a corresponding push button, and the large end portion is matched with a slideway of the pushing slide rail and is limited to enter the inner cavity of the sheath tube fixing seat. The shaft length is configured in a cylindrical shape, and the length of the shaft length is greater than or equal to a distance between the first rest position and the second rest position.

Further, a section of the actuating shaft located inside the handle housing is sleeved with a first reinforcing tube, the first reinforcing tube is fixedly coupled with the actuating shaft, and the first set of sealing structures seal the actuating shaft by sealing the first reinforcing tube.

Further, a second stiffening tube is sleeved on the distal side of the first stiffening tube, the proximal end of the second stiffening tube is fixed to the first set of sealing structures, and the distal end of the second stiffening tube extends into the inner cavity of the sheath fixing seat.

In another aspect, a delivery system for delivering an implant includes a first sheath assembly and a second sheath assembly, the second sheath assembly being the sheath assembly of the above aspect. The first sheath assembly has a handle and a sheath extending from the handle in an axial direction, the sheath of the first sheath assembly having a distal end portion including a steerable section. The multi-lumen tube of the second sheath assembly extends coaxially through the sheath of the first sheath assembly. Wherein a relative fixation mechanism is provided between the handle of the second sheath assembly and the handle of the first sheath assembly, the relative fixation mechanism extending distally from the handle housing of the second sheath assembly, the relative fixation mechanism being configured to maintain a fixed distance between the handle of the first sheath assembly and the handle of the second sheath assembly.

The invention provides a delivery system with replaceable valve clamps and repeated use, in particular a sheath tube assembly for controlling an implant, which can reduce the stock and transportation cost of the instrument, reduce the use cost and bring great benefit to patients. In addition, each module of the conveying system is clearly divided, each operation part of the handle accords with ergonomics, the valve clamp release structure is effectively integrated into the handle, the whole valve clamp control line does not need to be drawn out, the operation time is effectively shortened, and a foundation is laid for secondary use of the conveying system. The invention has the advantages of 1) higher surgical flexibility, allowing the replacement of the clamps according to the needs in the surgical process, not needing to replace the whole conveying system, increasing the flexibility and adaptability of the surgery, 2) reducing cost and resource waste, reducing inventory and transportation cost and resource waste because the whole system is not required to be prepared for each possible condition, 3) improving the surgical efficiency, reducing the risks of surgical interruption and prolonging the surgical time if the clamps with different specifications are damaged or needed in the surgery, 4) reducing the risks of patients, reducing the surgical time by quickly replacing the clamps, reducing the risks of the patients facing long-term surgery, 5) being easy to operate and learn, having easy system operation and short learning curve.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings required for the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present disclosure, and other drawings may be obtained according to these drawings without inventive effort for a person of ordinary skill in the art.

FIG. 1 shows a schematic view of a valve repair system of the present disclosure;

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

FIG. 3 shows a schematic view of two of the sheath tube assemblies and the relative securing mechanism therebetween in the delivery system of the present disclosure;

FIG. 4 shows a schematic view of a sheath and tube assembly for manipulating an actuation wire and an actuation shaft and an implant coupled thereto in a delivery system of the present disclosure;

FIG. 5A shows a perspective view of a handle of a sheath assembly for coupling, manipulating an actuation wire and an actuation shaft;

FIG. 5B shows an exploded view of the handle housing of the handle of FIG. 5A and the components coupled thereto;

FIG. 6A shows a portion of the handle of FIG. 5A with portions of the handle housing and internal components removed, illustrating a basic arrangement of push-pull components for manipulating axial movement of the actuation wire;

FIG. 6B shows an exploded view of the push-pull member of FIG. 6A, i.e., a pair of push seats and a pair of push buttons;

FIG. 6C is a schematic cross-sectional view of a pair of push buttons taken transversely from the center of the push buttons looking proximally in a first rest position, illustrating a laterally coupled state of the pair of push buttons and the pair of push seats when the two actuator wires are independently controlled to move axially;

FIG. 6D is a schematic cross-sectional view of a pair of push buttons taken transversely from the center of the push buttons and looking proximally in a first rest position, showing a laterally coupled state of the pair of push buttons and the pair of push seats when the two actuation wires are simultaneously controlled to move axially;

Fig. 7A and 7B are a perspective view and an exploded view, respectively, showing a third stopper portion that does not include a chute mechanism;

FIG. 8A is a schematic longitudinal cross-sectional view of a second push button, with some components removed for clarity of illustration, illustrating the positional relationship between the stops of the first stop, push seat, and third stop when the push button is in the first resting position;

FIG. 8B is a schematic longitudinal cross-sectional view of the second push button, illustrating the positional relationship between the stops of the second stop, the push seat, and the third stop, with some components removed for clarity of illustration, when the push button is in the second resting position;

Fig. 8C and 8D show perspective views of the push rail from the top and from the bottom, respectively;

FIG. 9A shows a portion of the handle of FIG. 5A with a portion of the handle housing removed, illustrating the basic arrangement of the sheath mount;

FIG. 9B shows a schematic cross-sectional view looking distally at the junction of the sheath anchor with the actuation wire pullback assembly;

FIG. 9C shows a schematic cross-sectional view looking proximally at the actuation wire retraction assembly of the handle of FIG. 5A;

FIG. 10A shows a schematic longitudinal cross-sectional view along the central axis of the handle of FIG. 5A with the actuating shaft removed, and FIG. 10B shows an enlarged partial schematic view at M1 of FIG. 10A;

FIG. 10C shows an exploded view of the sheath anchor and the first set of sealing structures;

FIG. 10D illustrates a top view schematic of a handle of a sheath assembly for coupling, manipulating an actuation wire and an actuation shaft when the actuation shaft is in a first proximal position;

FIG. 11A shows an exploded view of a portion of the components of FIG. 5A coupling the proximal end of the handle with the axial stop;

11B and 11C illustrate schematic cross-sectional views of the axial stop at the proximal end when the axial stop is in a first position providing axial stop to the actuation shaft and releasing the axial stop, respectively;

11D and 11E illustrate schematic cross-sectional views of the axial stop at the proximal end when the axial stop is in a second position providing axial stop to the actuation shaft and releasing the axial stop, respectively;

FIGS. 12A and 12B show schematic cross-sectional views looking proximally when the one-way clutch is limiting and releasing one-way rotation, respectively, of the cylinder;

fig. 12C shows an exploded view of a portion of the components of fig. 5A where the proximal end of the handle is coupled to a one-way clutch.

Detailed Description

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, and it is apparent that the described embodiments are only some embodiments of the present disclosure, but not all embodiments. Based on the embodiments in this disclosure, all other embodiments that a person of ordinary skill in the art would obtain without making any inventive effort are within the scope of protection of this disclosure.

In describing the present invention, "proximal" or "proximal" refers to a direction toward the end of the device that is manipulated by the user outside the patient's body, and "distal" or "distal" refers to a direction toward the working end of the device that is positioned at the treatment site and away from the user. When one or more components are described as being connected, joined, fixed, coupled, attached, or otherwise interconnected, such interconnection may be direct interconnection between the components, or may be indirect interconnection, such as through the use of one or more intervening components. The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions unless specifically defined otherwise. The term "radial" refers to a direction disposed perpendicular to an axis and pointing from a radius from the center of an object (where the axis is centered). The term "longitudinal section" refers to a section taken along the length or axial direction of the device, and the term "transverse section" refers to a section taken along the width or radial direction of the device. The term "inner" refers to a direction in a lateral/radial direction towards the central axis of the device. The term "outboard" refers to a direction in a transverse/radial direction away from the central axis of the device.

Direction and other relative references (e.g., upper, lower) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. When dealing with relative relationships, particularly with respect to the illustrated examples, such terms are used where applicable to provide some clear description. However, such terms are not intended to imply absolute relationships, positions, and/or orientations. For example, the "upper" portion for an object may be changed to the "lower" portion simply by flipping the object. Nevertheless, it is still the same part and the object remains unchanged.

The present invention provides an interventional device 10 (e.g., a valve repair system) for grasping, approximating and clamping tissue, such as leaflets, for treating heart valve regurgitation, particularly mitral valve regurgitation, and referring to fig. 1, the interventional device 10 includes an implant 100 and a delivery system 20, wherein the delivery system 20 may include a plurality of sheath assemblies. Delivery system 20 is configured to facilitate movement of the implant between its various configurations and/or implantation of the implant into a native heart valve.

In some embodiments, as shown in the example shown in fig. 2, the delivery system 20 includes a sheath tube assembly 250, a sheath tube assembly 260, and a sheath tube assembly 270. However, in some embodiments, delivery system 20 may include fewer or more sheath assemblies than shown in the figures. In some embodiments, sheath assembly 270 is configured as an introducer sheath assembly, sheath assembly 260 is configured as an steerable sheath assembly, and sheath assembly 250 is configured as an implant steering sheath assembly.

In some embodiments, the sheath tube assembly 260 extends coaxially through the sheath tube assembly 270, and the sheath tube assembly 250 extends coaxially through the sheath tube assembly 260 and the sheath tube assembly 270. Implant 100 can be releasably coupled to a distal portion of sheath assembly 250.

As shown in fig. 2, each of the sheath assemblies includes a sheath/shaft/sheath 59, 69, 79 extending from handles 51, 61, 71, respectively. Handles 51, 61, 71 are located at the proximal end of each of the corresponding sheaths/shafts/sheaths and contain one or more control members to enable a user to manipulate the sheath assembly (e.g., bend or rotate the sheath/shaft/sheath of the sheath assembly) or control components coupled to the corresponding sheath assembly (e.g., actuation shaft and actuation wire extending through the sheath/shaft/sheath of the sheath assembly).

Sheath assembly 270 and sheath assembly 260 may be used, for example, to approximate an implantation site (e.g., the native mitral valve region of the heart) and/or to position sheath assembly 250 at the implantation site. Thus, in some embodiments, both sheath assembly 270 and sheath assembly 260 are configured to be steerable (bendable).

Sheath assembly 250 includes handle 51, actuation shaft 220, actuation wire 230, and sheath 59, sheath 59 being configured as a multi-lumen tube through which actuation shaft 220, actuation wire 230 are releasably coupled distally to implant 100, the proximal ends of actuation shaft 220, actuation wire 230 being coupled to a control member in handle 51. Manipulation of the implant 100 by the actuation shaft 220 and actuation wire 230 of the sheath assembly 250 may operate in the same manner as shown and described in the chinese patent application publication CN118161307a, the entire contents of which are incorporated herein by reference.

Referring to fig. 3, in accordance with the delivery system 20 provided by the present invention, a relatively fixed mechanism 544 is provided between the handle 51 of the sheath assembly 250 and the handle 61 of the sheath assembly 260. During the process of taking out the delivery system 20 from the package and placing it on the stabilizer by an operator, or during the process of withdrawing the delivery system 20 for secondary loading and placing it on the stabilizer, the sheath 59 is easily damaged when the operator grabs one of the handles because the sheath 59 is soft, and the sheath 59 can be protected by adding the relative fixing mechanism 544. Illustratively, the relative securing mechanism 544 is configured to include a sleeve 544a, a sleeve 544b, and a tightening bolt 544c, the sleeve 544a being relatively fixedly coupled to the distal end of the handle 51, the sleeve 544b being relatively fixedly coupled to the proximal end of the handle 61, the distal end of the sleeve 544a and the proximal end of the sleeve 544b being nested with one another, wherein threaded holes are provided in the walls of the nested outer sleeves, and the tightening bolt 544c being screwed into the threaded holes to secure the two sleeves, thereby maintaining a fixed axial distance between the handle 51 and the handle 61. Preferably, the axial distance between the handle 51 and the handle 61 is adjustable, in particular, the distance between the handle 51 and the handle 61 can be adjusted by adjusting the depth to which the two sleeves nest with each other, i.e. the distance between the distal end of the sleeve 544a and the proximal end of the sleeve 544 b. The distance between the handle 51 and the handle 61 becomes larger as the distance between the distal end of the sleeve 544a and the proximal end of the sleeve 544b becomes smaller, and the distance between the handle 51 and the handle 61 becomes smaller as the distance between the distal end of the sleeve 544a and the proximal end of the sleeve 544b becomes larger. By adjusting the distance between the sleeve 544a and the sleeve 544b, the sheath assembly 250 may be moved axially relative to the sheath assembly 260, thereby adjusting the relative position of the implant within the heart.

More specifically, sleeve 544a is configured as an outer sleeve, sleeve 544b is configured as an inner sleeve, and sheath 59 extends coaxially through sheath assemblies 260 and 270 after extending from handle 51 through sleeve 544 b. The proximal end of the sleeve 544a is provided with internal threads, the sleeve 544a is threadably secured to the distal end of the handle 51, the wall of the distal end of the sleeve 544a is provided with threaded holes, and a fastening bolt 544c passes through the threaded holes of the distal end of the sleeve 544a to secure the two sleeves. The proximal end of the handle 61 is provided with a fixing plate, and the distal end of the sleeve 544b is fixedly coupled to the fixing plate of the proximal end of the handle 61 by means of screw threads. The proximal end of the sleeve 544b is provided with a flange structure that matches the size of the lumen of the sleeve 544a and that cooperates with the distal features of the sleeve 544a to prevent the sleeve 544b from being separated from the sleeve 544a, thereby limiting the maximum relative travel distance between the handle 51 and the handle 61 and preventing an operator from operating the sheath 59 during use.

Fig. 4 shows a schematic view of an implant handling sheath assembly 250, with reference also to fig. 1, in which the actuation wires 230 are configured in pairs, the sheath 59 (multi-lumen tube) having at least three longitudinally extending lumens, one for arranging the actuation shaft 220 and two for arranging one actuation wire 230 each. Each actuator wire 230 is coupled to an actuator wire control mechanism 530 positioned on the handle 51, and the actuator shaft 220 is coupled to an actuator shaft control mechanism 520 positioned on the handle 51. The actuation shaft 220 may extend distally from the actuation shaft control mechanism 520, through the handle 51, through the sheath 59, and distally coupled to the implant 100. The actuation shaft 220 may be axially movable and/or rotationally movable relative to the sheath 59 and the handle 51. The actuation wire 230 may extend distally from the actuation wire control mechanism 530, through the handle 51, the sheath 59, and distally coupled to the blade 160 of the implant 100. The actuation wire 230 may be axially movable relative to the handle 51 and sheath 59, and may also be axially movable relative to the actuation shaft 220.

In accordance with the implant handling sheath assembly 250 provided herein, the distal end of each actuation wire 230 is disposed proximal to the distal side of the sheath 59, the proximal end of each actuation wire 230 is disposed proximal to the sheath 59, and each actuation wire 230 moves the blade 160 of the implant 100 in a monofilament motion as the implant 100 is handled. After implant 100 has been completely implanted and disengaged from actuation shaft 220 and actuation wire 230, actuation shaft 220 and actuation wire 230 may be maintained at the distal end of sheath 59 for reuse to complete the secondary coupling to a new implant. It should be noted that the actuation wire in the prior art generally has a "U" shaped configuration having a first section extending distally from the proximal end of the delivery system and a second section folded back from the distal end of the delivery system to the proximal end along the axial length of the delivery system, with both the distal and proximal ends of the actuation wire being proximal to the delivery system. The actuation wire 230 of the present disclosure is in a "monofilament" configuration, meaning that one end of the actuation wire 230 is proximal to the delivery system 20 and the other end is distal to the delivery system 20, and not meaning that the actuation wire 230 itself is a single strand or a single wire.

Referring to fig. 5A and 5B, the handle 51 includes a handle housing 511, and the handle housing 511 may be constructed of an upper housing 511a and a lower housing 511B that can be fastened to each other, and the interior of the handle housing 511 may provide accommodation spaces for a plurality of components. The handle housing 511 generally comprises two sections in a longitudinal direction, with the proximal end of the actuation wire 230 and the actuation wire control mechanism 530 disposed and attached to the distal section of the handle housing 511 and the proximal end of the actuation shaft 220 and the actuation shaft control mechanism 520 disposed and attached to the proximal section of the handle housing 511.

In accordance with the sheath tube assembly 250 provided herein, the actuation wire 230 in a "monofilament" configuration includes a single row of body segments extending through the sheath 59 and a return segment adjacent the proximal side of the body segments that does not pass through the sheath 59, the return segment being coupled to a push-pull member (described in detail below) of the actuation wire control mechanism 530. The push-pull member of the actuation wire control mechanism 530 is axially movable relative to the handle housing 511, the axial movement of the push-pull member being capable of moving the blade 160 of the implant 100 between the open and closed configurations. Specifically, axial movement of the push-pull member can cause the actuation wire 230 to move axially, thereby causing the cleat 160 coupled to the actuation wire 230 to move. It should be noted that, a precondition for the manipulation of the actuating wire 230 by the actuating wire control mechanism 530 in the present invention is that the implant 100 is in an open state (the clip 150 is in an open state, refer to fig. 1).

According to one or more embodiments provided herein, as the push-pull member moves axially, the actuator wire 230 withdraws or advances a greater distance than the push-pull member moves axially. Illustratively, the return section of the actuation wire 230 includes only one return, the actuation wire 230 being axially retracted or advanced a distance twice as long as the axial movement of the push-pull member. The actuating wire of the U-shaped loop completely releases the button plate and the stroke of the whole conveying system is required to be completed, but the actuating wire of the 'monofilament' loop completely releases the button plate and the stroke of the button plate to the far end of the sheath 59 is only required to be completed, the stroke of the whole conveying system is not required to be completed, and the moving distance of the actuating wire withdrawing can be effectively shortened, so that the actuating wire withdrawing time is shortened, and the operation time is shortened. In addition, the actuator wire need not be completely withdrawn from the delivery system, and the secondary loading of the implant may be achieved, and the actuator wire control mechanism 530 may reduce the distance the actuator wire travels in the handle segment, thereby reducing the overall size of the handle.

Optionally, the push-pull member in the actuation wire control mechanism 530 is configured to operate only two actuation wires 230 simultaneously (in a coordinated manner), optionally, the push-pull member in the actuation wire control mechanism 530 is configured to operate only two actuation wires 230 independently, and preferably, the push-pull member in the actuation wire control mechanism 530 is configured to operate both actuation wires 230 independently, and both actuation wires 230 simultaneously (in a coordinated manner). In accordance with one or more embodiments provided herein, the push-pull components of the actuation wire control mechanism 530 are configured to at least independently manipulate two actuation wires 230, respectively.

In some embodiments, a push slide rail 512 is provided in the handle 51, the push slide rail 512 being axially extending disposed inside the handle housing 511 and fixed relative to the handle housing 511. The actuation wire control mechanism 530 is configured to include an axially movable push-pull member, at least a portion of which is axially movable along the push slide rail 512, the return section of the actuation wire 230 being attached to the push-pull member, the actuation wire 230 moving with axial movement of the push-pull member, tensioning or relaxing the actuation wire 230. Alternatively, the push-pull member is configured as a separate body, and the push-pull member includes a driving member (e.g., a second push button 532b described below) and a driven member (e.g., a second push holder 531b described below). Alternatively, the push-pull member is configured as a single body, and the push-pull member includes only the active member (for example, a single body of the first push button 532a and the first push holder 531a described below).

In one embodiment, the push-pull member includes a push seat and a push button. The push button is coupled to the push seat, and the actuation wire 230 is coupled to the push seat, the push button being configured to move axially relative to the push rail 512 to move the push seat axially, and the push seat moves axially to move the actuation wire 230 axially.

Referring to fig. 6A and 6B, the push seats are configured as a pair, both push seats extend in the axial direction, one of the push seats is provided with a first connection portion 533, the other push seat is provided with a second connection portion 534, the proximal end of one actuation wire 230 is attached to the first connection portion 533 and folded back distally and fixed with respect to the handle housing 511, and the proximal end of the other actuation wire 230 is attached to the second connection portion 534 and folded back distally and fixed with respect to the handle housing 511. Illustratively, the proximal end of the actuator wire may be secured to the handle housing 511 by knotting, adhesive, threading, or staking.

Specifically, the first and second connection portions 533 and 534 may be configured in a cavity, hole, groove, loop, ring, hook, or the like structure that enables the actuating wire 230 not to be disconnected from the push holder, and enables frictional resistance to be small at a position contacting the folded-back section of the actuating wire 230 when the push holder is axially moved. The first connection 533 and the second connection 534 may be provided at distal ends, proximal ends, or other suitable locations of the two push seats, respectively. Preferably, the first connection portion 533 and the second connection portion 534 may be provided at distal ends of the two push seats, respectively, and the stroke of the actuating wire is required to enable the two tabs to be moved open by 360 °.

In some embodiments, the push buttons are configured such that one push button is switchably coupled to either push pad, and one push button can control axial movement of either push pad or both push pads. In other embodiments, the push buttons are configured as a pair, the two push buttons can be connected to form a whole, each push button controls the axial movement of one push seat when the two push buttons are not connected, and any one push button can simultaneously control the axial movement of the two push seats when the two push buttons are connected.

Alternatively, the push buttons are configured as one, one push button selectively operable one or both push seats. The push button is provided with a first push seat coupling part and a second push seat coupling part which are arranged in the radial direction, and the first push seat coupling part and the second push seat coupling part can be selectively moved in the radial direction to be coupled with the corresponding push seats, so that the push button can operate one or two push seats. The pushing seat coupling part can be radially moved by pressing, so that the pushing seat coupling part is coupled with or decoupled from the pushing seat.

Alternatively, the push buttons are configured as a pair, with two push buttons each coupled to one push pad. Referring to fig. 6A and 6B, for convenience of description, a pair of push buttons are defined as a first push button 532a and a second push button 532B, a pair of push seats are defined as a first push seat 531a and a second push seat 531B, and a pair of actuating wires 230 are defined as a first actuating wire 230a and a second actuating wire 230B. The first push button 532a is configured to be axially movable with respect to the push rail 512 to thereby axially move the first push holder 531a, and the axial movement of the first push holder 531a axially moves the first actuating wire 230a connected thereto. The second push button 532b is configured to be axially movable with respect to the push rail 512 to thereby axially move the second push holder 531b, and the axial movement of the second push holder 531b axially moves the second actuating wire 230b connected thereto. Preferably, the push button has a grip portion 538, and the grip portion 538 protrudes out of the handle housing 511 for user operation.

In some embodiments, referring to fig. 6B, the first push button 532a and the first push seat 531a are configured as a unitary structure, the grip portion 538 of the first push button 532a is formed outside of the proximal end of the first push seat 531a, and the proximal end of the first push seat 531a is configured to include radially extending engagement slots 535a. The second push button 532b and the second push holder 531b are configured as a split structure, the proximal end of the second push holder 531b is configured to include a radially extending engagement hole 535b, a coupling shaft 535c is provided in the engagement hole 535b, and the second push button 532b is selectively coupled with the second push holder 531b and the first push holder 531a via the coupling shaft 535 c. Specifically, the second push button 532b is provided with a driving shaft 535d extending radially inward of the handle housing 511 from the grip portion 538, the driving shaft 535d is provided with external threads, the coupling shaft 535c is provided with internal threads, the driving shaft 535d is rotatably inserted into the coupling shaft 535c, and the second push button 532b is rotated to drive the coupling shaft 535c to move in the axial direction of the driving shaft 535 d. Wherein the driving shaft 535d of the second push button 532 is restrained from radial movement by the handle housing 511 upon rotation, the engagement hole 535b is configured to restrict rotation of the coupling shaft 535d relative to the second push seat 531b while radially receiving the coupling shaft 535 c. When the first and second push buttons 532a, 532b are axially flush, radially aligned, rotation of the second push button 532b in a first direction drives the linkage shaft 535c to translate radially, at least a portion of the linkage shaft 535c into the engagement slot 535a such that the first and second push seats 531a, 531b are relatively fixedly coupled together to form a unitary body. When the first pushing seat 531a and the second pushing seat 531b are coupled together to form a whole, referring to fig. 6D, the axial movement of any one push button can drive the two pushing seats 531 to move (link) synchronously, so as to drive the two actuating wires 230 to control the opening or closing of the two tabs 160 on the implant 100 synchronously. Further, the second push button 532b can rotate in a second direction to drive the linkage shaft 535C out of engagement with the grooves 535a, allowing the first and second push seats 531a and 531b to resume independent movement, thereby allowing the two actuation wires 230 to independently control the opening or closing of the two flaps 160 on the implant 100, respectively, as seen in fig. 6C. Illustratively, the first direction is a counterclockwise direction as viewed from the second push button 532b toward the first push button 532a, and the second direction is a clockwise direction as viewed from the second push button 532b toward the first push button 532 a.

Further, referring to fig. 5A, each push button has a first resting position corresponding to axial movement of actuation wire 230 to move cleat 160 to a position in an open configuration away from coaptation element 120, and a second resting position corresponding to axial movement of actuation wire 230 to move cleat 160 to a position in a closed configuration proximate to coaptation element 120 (as shown in fig. 1). Specifically, a first limiting portion is disposed on the distal side of the push slide rail 512, a first stop position of the push button is at least limited by the first limiting portion, and a second limiting portion is disposed on the proximal side of the push slide rail 512, and a second stop position of the push button is at least limited by the second limiting portion.

In some embodiments, the first and second stops may be provided by design features on the handle housing 511 corresponding to an axial travel of the push button defined between the first and second rest positions. Specifically, the side wall of the handle housing 511 is provided with a side feature adapted to the axial movement and rest of the grip portion 538, for example, as shown in fig. 5A, an open slot 511c is provided in the side of the handle housing 511 for the axial movement of a push button, which extends through the open slot 511c to be coupled to a push seat, and a part of the handle housing 511 is configured as a flat surface along the length direction of the open slot 511c so as to be adapted to the abutment surface of the grip portion 538, so that the movement of the push button is smoother. The width of the open groove 511c is configured to be larger than the diameter of the coupling shaft between the grip portion 538 and the push holder but smaller than the lateral dimension of the grip portion 538 itself, and both ends in the length direction of the open groove 511c provide the first and second stopper portions 513 and 514.

In some embodiments, the first and second stops may be provided by components within the handle housing 511 corresponding to an axial travel of the push button defined between the first and second rest positions. For example, referring to fig. 6A, according to the push rail 512 provided by the present invention, the whole structure is flat, and the push button and the push seat axially move along the bottom surface of the push rail 512. Alternatively, protruding portions may be disposed on the bottom surfaces of the distal end and the proximal end of the push rail 512 in a downward extending manner, where the protruding portions can limit the axial movement of either the push button or the push seat, and the protruding portions on the distal end and the proximal end provide the first limiting portion and the second limiting portion. Optionally, a member similar to a baffle may be added to the distal end and the proximal end of the pushing rail 512, where the baffle can limit the axial movement of either the push button or the pushing seat, and the baffles at the distal end and the proximal end provide a first limit portion and a second limit portion.

In some embodiments, the first and second stops may also be provided by a combination of design features of the handle housing 511 itself and components internal to the handle housing 511, or one of the first and second stops may be provided by a combination of design features of the handle housing 511 itself and components internal to the handle housing 511, corresponding to an axial travel of the push button defined between the first and second stop positions. The specific implementation is similar to the previous implementation, and will not be repeated.

Further, a third limiting part capable of releasing the limiting effect is arranged at the axial position between the first limiting part and the second limiting part. When the push button is located at the first rest position, the third limiting portion performs a limiting function to limit the push button to move proximally, so that the push button can be prevented from being erroneously operated to change the state of the button piece 160 that has been adjusted to the open configuration. When the push button is in the second resting position, the third limiting portion is configured to limit the distal movement of the push button, thereby preventing the push button from being moved distally by the tensioned actuator wire 230 to change the state of the tab 160 that has been adjusted to the closed configuration. The push button is movable from the first rest position to the second rest position or from the second rest position to the first rest position with the third limit portion released from the limit.

In some embodiments, referring to fig. 5A, 5B, 7A, and 7B, the third limit portion 515 is configured as a push-spring self-locking structure, including a button 53, a dial 582, a chute mechanism 581, a first spring 583a, a telescoping lever 561, and a stop 562. The slide groove mechanism 581 is fixed with respect to the upper case 511a and extends in the pressing direction of the push button 53. Optionally, the chute mechanism 581 is integrally formed with the upper housing 511 a. The button 53 and the dial 582 are arranged in the pressing direction and are both coupled to the chute mechanism 581, and a side of the button 53 remote from the dial 582 protrudes from the chute mechanism 581 so as to receive the pressing. One end of the first spring 583a abuts against the rotary plate 582, and the other end of the first spring 583a abuts against the push slide rail 512. One end of the telescopic link 561 is coupled to the rotary table 582, and the other end of the telescopic link 561 is coupled to the stopper 562. Optionally, the telescoping lever 561 and stop 562 are integrally formed.

Preferably, the third limiting portion 515 further includes a blocking piece 586a and a second spring 583b, the upper end of the telescopic rod 561 is provided with a clamping groove 586b, and the blocking piece 586a is placed in the clamping groove 586b and is abutted against the upper surface of the rotary plate 582. The upper end of the telescopic link 561 is coupled to the rotary plate 582 by a flap 586 a. The first spring 583a abuts between the lower surface of the rotating plate 582 and the upper surface of the push rail 512. The second spring 583b abuts against the rotary plate 582 and the telescopic rod 561, and the second spring 583b cooperates with the flap 586a to integrally couple the rotary plate 582 and the telescopic rod 561. Providing the blocking piece 586a and the second spring 583b may facilitate the installation of the third limiting part 515.

The button 53 is provided with a first tooth 584 for pushing the rotary plate 582, the rotary plate 582 is provided with a second tooth 585, the chute mechanism 581 is provided with long locking grooves and short locking grooves which are alternately arranged in the circumferential direction, and the rotary plate 582 and the long locking grooves and the short locking grooves can be alternately coupled by pressing the button. Correspondingly, the button 53 is in a depressed state when the second tooth 585 of the dial 582 is engaged in the short locking groove, and the button 53 is in a sprung state when the second tooth 585 of the dial 582 is engaged in the long locking groove.

Pressing the button 53 moves the stopper 562 of the third stopper 515 in the pressing direction, so that the stopper 562 restricts or releases the restriction of the push-pull member from moving axially. Specifically, when the push button 53 is in the pressed state, the telescopic rod 561 protrudes in the pressing direction of the push button 53, and the stopper 562 is driven by the telescopic rod 561 onto the travel route of the push-pull member (push button and/or push seat), and the stopper 562 blocks the axial movement of the push-pull member. The push button 53 is pressed again to bring the push button 53 into a sprung state, the telescopic rod 561 is retracted in the sprung direction of the push button 53, and the stopper 562 is driven by the telescopic rod 561 to a travel path away from the push-pull member (push button and/or push seat), the stopper 562 not blocking the axial movement of the push-pull member.

Specifically, for the manner of construction of the pair of push seats and the pair of push buttons, the stopper 562 is constructed to include a pair of axially extending stoppers 562a, 562b, with the stoppers 562a and 562b coupled by a cross member 562c, such that the stopper 562 as a whole forms an i-shaped member. The telescopic rod 561 is coupled in particular to the cross beam 562c of the stop block 562, the stop block 562a being adapted to define the position of the first push button 532a and/or of the first push seat 531a, and the stop block 562b being adapted to define the position of the second push button 532b and/or of the second push seat 531 b. The axial length of the stops 562a, 562b is such that the distal ends of the stops 562a, 562b extend to an axial position capable of defining the stabilization of the push button in the first rest position and the proximal ends of the stops 562a, 562b extend to an axial position capable of defining the stabilization of the push button in the second rest position.

More specifically, referring to fig. 6B, the push seat includes a proximal large end 537a and an axial length 537B extending distally from the large end. The large end 537a has oppositely disposed distal and proximal faces 537c, 537d, the lateral dimension of the distal face 537c being greater than the lateral dimension of the shaft length 537b. Taking the second pushing seat 531B and the second push button 532B as an example, referring to fig. 8A, when the second push button 532B is located at the first rest position and the third limiting portion 515 performs the limiting action, at least a portion of the proximal surface 537d is blocked by the distal end of the stopper 562B, and referring to fig. 8B, when the second push button 532B is located at the second rest position and the third limiting portion 515 performs the limiting action, at least a portion of the distal surface 537c is blocked by the proximal end of the stopper 562B.

More specifically, referring to fig. 8C, the push rail 512 is integrally configured in a flat plate shape, a receiving space 557 adapted to receive the stopper 562 is provided in the middle of the push rail 512, and positions corresponding to the stoppers 562a and 562b in the receiving space 557 are configured to be vertically penetrated. When the telescopic lever 561 is extended in the pressing direction of the push button 53, the stoppers 562a, 562B can be moved downward from the accommodating space 557 to cause the lower surfaces of the stoppers 562a, 562B to pass over the lower surface of the push rail 512, thereby constituting an obstacle on the axial travel path of the push button and/or the push seat (refer to fig. 8A and 8B). When the telescopic link 561 is retracted toward the pop-up direction of the push button 53, the stoppers 562a, 562b can be moved upward from the accommodation space 557 to cause the lower surfaces of the stoppers 562a, 562b to pass over the top of the large end 537a, so as not to constitute an obstacle in the travel path of the push button and/or the push seat. The button 53 of the third stopper 515 is attached to the outer wall of the upper case 511a, and the telescopic rod 561 extends from the button 53 into the accommodating space 557 through the upper case 511 a. Further, a non-button side mating feature 559, e.g., a spring mating feature, a telescoping rod mating feature, etc., that mates with the push-button self-locking feature is also provided in the receiving space 557.

In some embodiments, the large end 537a is configured Fang Xingti, and the upper surface of the square body can smoothly move axially along the bottom surface of the flat plate-shaped push rail 512. To accommodate the axial movement of the large end 537a of the square body, preferably, referring to fig. 8D, the bottom of the push rail 512 is provided with a longitudinally extending partition 556, the partition 556 forming two slides 558a, 558b in the bottom of the push rail 512, corresponding to the axial travel of the push button defined between the first and second rest positions. Referring also to fig. 6C, in the sliding space of the large end 537a, both the outer side wall of the partition 556 and the inner side wall of the handle case 511 are constructed in a planar structure suitable for the planar translation of the square body wall. In addition, the proximal and distal ends of the push rail 512, the partition 556 are each provided with structural features adapted to mount the deployment actuation shaft 220 and the stiffening tube.

Referring to fig. 9A to 9C, a sheath holder 516 is further provided in the handle 51, the sheath holder 516 being axially extending provided inside the handle housing 511 and fixed with respect to the handle housing 511, the proximal end of the sheath 59 being fixedly coupled to the distal end of the sheath holder 516. More specifically, the sheath mount 516 is located at a distal end of the push rail 512, and the sheath mount 516 is fixed relative to the push rail 512. The sheath holder 516 is configured with at least a longitudinally extending lumen 517, the lumen 517 of the sheath holder 516 providing a corresponding travel of the active space and receiving space for a segment of the proximal end of the actuation wire 230 that is axially movable by the push-pull member, i.e., the portion of the push-pull member coupled with the actuation wire 230. In addition, the lumen 517 of the sheath mount 516 also provides a passageway for the actuation shaft 220 to extend through.

In a specific embodiment, the lumen 517 of the sheath anchor 516 includes a first subchamber 517a, a second subchamber 517b, and a transition chamber 517c therebetween, the transition chamber 517c communicating the first subchamber 517a with the second subchamber 517b from an upper side. A longitudinally extending spacer 517d is provided between the first and second subchambers 517a, 517b, the spacer 517d laterally separating the first and second subchambers 517a, 517 b. The first sub-chamber 517a may provide the active space and accommodation space of the respective stroke for the first pushing seat 521a and the second sub-chamber 517b may provide the active space and accommodation space of the respective stroke for the second pushing seat 521b, the actuation shaft 220 in the handle 51 extending into the sheath 59 via the transition chamber 517 c. The proximal end of the first actuating wire 230a is connected to the first connection portion 533 in the first sub-chamber 517a in an extending manner and is fixed to one lateral side of the handle housing 511 in a folded-back manner in the distal direction, and the proximal end of the second actuating wire 230b is connected to the second connection portion 534 in the second sub-chamber 517b in an extending manner and is fixed to the other lateral side of the handle housing 511 in a folded-back manner in the distal direction.

More specifically, when the push button is in the first rest position, referring to fig. 8A, 9B and 10A together, a majority (distal) of the shaft length 537B is located in the inner cavity 517, and the large end 537a is located in the space defined by the push slide rail 512 and the lower housing 511B. When the push button is in the second rest position, referring to fig. 8B, only the distal end of the shaft length 537B is located in the inner chamber 517, and the majority (near side) of the shaft length 537B and the large end 537a are both located in the space defined by the push slide rail 512 and the lower housing 511B.

Further, in accordance with the sheath tube assembly 250 provided herein, the proximal end of the actuation wire 230 is releasably secured to the handle housing 511. The handle 51 also provides a pair of actuation wire retraction assemblies corresponding to the securement of the proximal ends of the pair of actuation wires 230 on either lateral side of the handle housing 511. Referring to fig. 5A, 6A and 9C, a first actuation wire retraction assembly 518a is secured to a lateral side of the handle housing 511, a proximal end of the first actuation wire 230a (an outboard end of the return section) is coupled to the first actuation wire retraction assembly 518a, the first actuation wire retraction assembly 518a being configured to pull the proximal end of the first actuation wire 230a outboard from the handle housing 511. A second actuation wire retraction assembly 518b is secured to the lateral other side of the handle housing 511, a proximal end of the second actuation wire 230b (the outboard end of the return segment) being coupled to the second actuation wire retraction assembly 518b, the second actuation wire retraction assembly 518b being configured to pull the proximal end of the second actuation wire 230b outboard away from the handle housing 511. Wherein when the proximal end of the first actuation wire 230a or the proximal end of the second actuation wire 230b is pulled away from the handle housing 511, the push button coupled to the corresponding actuation wire is in the second resting position. Illustratively, when the two actuation wires 230 are each independently manipulated to move axially, pulling the proximal end of the first actuation wire 230a away from the handle housing 511 occurs with the first push button 532a in the second resting position and pulling the proximal end of the second actuation wire 230b away from the handle housing 511 occurs with the second push button 532b in the second resting position. After the implant 100 is in the closed configuration, the distal end of the actuation wire 230 may be disconnected from the blade 160 by pulling the proximal end of the actuation wire 230 away from the handle housing 511, thereby disengaging the implant 100 and completing the implantation procedure. Because the distal end of the actuation wire 230 is provided with a stop feature that mates with the distal end of the sheath 59, the distance that the proximal end of the actuation wire 230 is pulled away from the handle housing 511 is limited, thereby ensuring that the distal end of the actuation wire 230 is defined distally of the sheath 59 for reattachment to the blade 160 upon secondary loading of the implant.

Referring to fig. 9C, each of the actuating wire pullback assemblies includes a pullback holder 563, a seal cap 564, a pullback rod 565, and a pullback rod cap 566. The withdrawal fixing seat 563 extends in a lateral direction, one end of the withdrawal fixing seat 563 is located at the inner side of the handle housing 511 and coupled with the sheath fixing seat 516, the other end of the withdrawal fixing seat 563 is located at the outer side of the handle housing 511, the seal end cap 564 is coupled to the withdrawal fixing seat 563 from the outer side of the handle housing 511, and the withdrawal lever cap 566 is detachably coupled to the seal end cap 564. Specifically, the pullback fixing base 563 and the sheath fixing base 516 may be hermetically connected by a threaded connection, a glue bonding, an ultrasonic welding, or an integrated molding. The back-out fixing seat 563 is provided with an inner cavity extending along a transverse direction of the handle 51, one end of the back-out lever 565 extends into the inner cavity of the back-out fixing seat 563, and the other end of the back-out lever 565 extends to the outer side of the seal end cap 564 and is fixedly coupled with the back-out lever cap 566, for example, the back-out lever 565 and the back-out lever cap 566 are fixedly coupled by means of clamping, glue bonding, ultrasonic welding or the like. The proximal end of the actuation wire 230 is folded back distally to the retraction mount 563 and passed through the lumen of the retraction mount 563 and fixedly coupled to the retraction rod 565. The pullback holder 563 and the seal cap 564 are fixed relative to the handle housing 511, and the pullback lever cap 566, when uncoupled from the seal cap 564, can drive the pullback lever 565 away from the sheath holder 516 and thereby drive the proximal end (the outer end of the turn-back section) of the actuation wire 230 away from the handle housing 511. Preferably, the inner end of the pullback lever 565 is configured as a flange structure, the outer end of the pullback lever 565 is fixedly connected to the pullback lever cap 566, and the outer end of the seal cap 564 provides a movable passage for the pullback lever 565 with a smaller cross-sectional dimension than the flange structure of the pullback lever 565. When the pull back lever cap 566 is operated to pull the pull back lever 565 outward, the flange structure of the pull back lever 565 stops pulling when it is restrained by the outer end of the seal end cap 564, i.e., the withdrawal distance of the pull back lever 565 is restrained, preventing the erroneous operation from breaking the coupled relationship of the actuating wire 230 and the distal end of the sheath 59.

Further, referring to fig. 10C, a luer 555 communicated with the inner cavity 517 is arranged at the top of the sheath tube fixing seat 516, the luer 555 is externally connected with a unidirectional luer 519, for example, the unidirectional luer 519 is directly adhered to the luer 555, so as to realize unidirectional exhaust sealing of the sheath tube fixing seat 516 and the sheath tube 59.

A first set of sealing structures sealing the actuation shaft 220 and push-pull member is provided at the proximal end of its lumen 517 in the longitudinal coupling direction of the sheath anchor 516. In particular, referring to fig. 10A-10C, a first set of sealing structures is provided at the junction of the distal end of the push rail 512 and the proximal end of the sheath mount 516. The first group of sealing structures includes a silicone sealing sheet 541a, two first O-rings 541b, a second O-ring 541c, a first cover plate 551, and a second cover plate 552. The top of the sheath tube fixing seat 516, the top of the first cover plate 551 and the top of the second cover plate 552 are basically flush, and the three are in sealing connection with each other in the axial direction through the silica gel sealing piece 541a, the first O-ring 541b and the second O-ring 541 c. The first set of sealing structures provides for sealing the entire lumen of the sheath anchor 516 in the axial direction while also providing for sealing the actuation shaft 220 or the first stiffening tube 223 (described below, with the actuation shaft 220 extending therethrough) and the shaft length 537 b. Further, in order to ensure the sealing effectiveness in the axial direction, the length of the shaft long portion 537b of the push holder is configured to be greater than or equal to the distance between the first and second rest positions (the axial maximum stroke of the push-pull member). In particular, the first connection portion 533 and the second connection portion 534 are respectively disposed at distal ends of the two pushing seats, and the proximal section of the actuation wire 230 is completely placed into the cavity of the sheath fixing seat 516, so that the sealing of the wire can be converted into the sealing of the axial length section of the pushing seat, and the sealing performance is improved.

The proximal end of the sheath holder 516 is configured with a recessed area 516a (see fig. 10C), a silicone seal 541a is seated within the recessed area 516a, and the exterior of the silicone seal 541a is configured to substantially conform to the lateral profile of the sheath holder 516, and a first cover 551 is press-fit the silicone seal 541a proximally and coupled to the proximal end of the sheath holder 516. The first cover plate 551 comprises two lateral channels 551b adapted to pass the pushing seats and a central channel 551a adapted to pass the actuation shaft 220, the preferred central channel 551a being provided by an axially extending cylindrical body receivable by the transition chamber 517c and not interfering with the axial movement of the two pushing seats. The proximal ends of the two side channels 551b are each provided with a recessed step 551c adapted to seat a first O-ring 541b therein, and the proximal end of the central channel 551a is provided with a recessed step 551d adapted to seat a second O-ring 541c therein. The second cover plate 552 presses on the two first O-rings 541b, 541c from the proximal side and at the same time provides an extension channel for the push seat and the actuation shaft 220. The first seal assemblies are preferably coupled together by fastening bolts 543 and placed in handle housing 511 after the first seal assemblies are fully assembled.

Further, in the lateral coupling direction of the sheath anchor 516, a second set of sealing structures is provided for each actuation wire pullback assembly. Specifically, with continued reference to fig. 9C, a silica gel sealing gasket 542a is provided at the coupling of the pullback fixing base 563 and the sheath fixing base 516, and a third O-ring 542b is provided between the lumen of the pullback fixing base 563 and the pullback fixing base 563. The second set of sealing structures provides for sealing the entire lumen of the sheath anchor 516 in the lateral direction while also providing for sealing the actuation wires.

The sheath anchor 516, having an internal lumen structure, firstly provides a coupling/securing location for the sheath 59, secondly provides a vent interface for gases within the sheath 59, and furthermore provides an interface, a free space or accommodation for the securing/axial movement of the proximal portion of the actuation wire itself, the axial movement of the push-pull member coupled to the actuation wire, and the axial movement of the actuation shaft. On the basis, the effective sealing of the small-diameter actuating shaft (or the reinforcing tube sleeved outside the actuating shaft) and the actuating wire is achieved by only arranging the basic sealing O ring and the sealing cover plate at the joint of the sheath tube fixing seat 516 and the pushing sliding rail 512 and the joint of the actuating wire withdrawing component, and meanwhile, the handle 51 is convenient to install and simple to operate, and the overall structure of the handle 51 is simplified.

Referring to fig. 6A and 10A, the actuating shaft 220 in the handle 51 is sleeved with a first stiffening tube 223, and a second stiffening tube 225 is further sleeved in a section of the lumen 517 located in the sheath holder 516, i.e., the second stiffening tube 225 is sleeved in a distal section of the first stiffening tube 223, more specifically, the second stiffening tube 225 is disposed in the lumen of the sheath holder 516. The first reinforcement tube 223 is axially movable within the second reinforcement tube 225, both reinforcement tubes simultaneously serving as support reinforcements for the actuation shaft 220. Alternatively, the stiffening tube may be omitted and the strength of one section of the actuation shaft 220 located in the handle 51 may be adjusted to be greater than the strength of another section of the actuation shaft extending in the sheath 59. Specifically, the material of the two-section reinforcing tube may be selected to be medical stainless steel. The proximal end of the first stiffening tube 223 is riveted, bonded or welded to the actuation shaft 220 at the proximal end of the handle 51, and the proximal end of the first stiffening tube 223 and the actuation shaft 220 at the proximal end of the handle 51 are bonded or integrally injection molded together and secured to the hollow lumen 582 (described below) of the cylinder 524. The second reinforcing tube 225 is fixed in the cavity extending from the first cover plate 551 by bonding or integral injection molding.

Extending the first reinforcement tube 223 into the cylindrical body 524 into the knob 584 may facilitate sealing of the first reinforcement tube. Specifically, in the first sealing assembly, the second O-ring 541c serves the purpose of sealing the actuating shaft 220 by sealing the first reinforcement pipe 223. Since the diameter of the actuating shaft 220 is smaller than that of the first reinforcement pipe 223 and the actuating shaft 220 needs to be moved axially, a better sealing effect can be achieved by enlarging the sealing size thereof by the first reinforcement pipe 223.

Referring to fig. 5A and 5B, the present invention provides an actuation shaft control mechanism 520 generally comprising a manipulation member, assembly or mechanism that enables longitudinal movement of the actuation shaft 220, thereby enabling movement of the jaws 150 of the implant 100 between an open position and a closed position. Specifically, the actuation shaft control mechanism 520 includes a control knob 521, the control knob 521 coupled to the actuation shaft 220, the control knob 521 rotatable relative to the handle housing 511, wherein rotation of the control knob 521 axially moves the actuation shaft 220 relative to the handle housing 511 and the sheath 59.

Further, a control knob 521 is rotatably coupled to the handle housing 511, the control knob 521 being selectively coupleable with the actuation shaft 220. When the control knob 521 is coupled with the actuation shaft 220, turning the control knob 521 may axially move the actuation shaft 220 relative to the handle housing 511 and the sheath 59. When the control knob 521 is decoupled from the actuation shaft 220, the actuation shaft 220 may be independently operated, such as by manually pulling the actuation shaft 220 to continue to move proximally.

Further, the actuating shaft control mechanism 520 further includes an axial limiter 522 that can release the limit, and the axial limiter 522 provides axial limit to the actuating shaft 220 in a first position and a second position in sequence during the process of operating the clip opening and closing of the implant 100 through the actuating shaft 220 until the actuating shaft 220 is completely separated from the implant 100 after implantation is completed. Wherein a first position and a second position are disposed proximal to the actuation shaft 220, the first position and the second position having an axial spacing, the first position being proximal to the second position. When the axial stop 522 provides an axial stop to the actuation shaft 220 in the first position, the actuation shaft 220 is axially movable between a distal position and a first proximal position under the rotation of the control knob 521. When the axial stop 522 provides axial stop to the actuation shaft 220 in the second position, the position of the actuation shaft 220 is fixed in the second proximal position. Wherein the jaws 150 of the implant 100 are in a fully open state (maximum opening angle, 360 °) when the actuation shaft 220 is in the distal position, the jaws 150 of the implant 100 are in a closed state when the actuation shaft 220 is in the first proximal position, the actuation shaft 220 is in a decoupled state from the implant 100 when the actuation shaft 220 is in the second proximal position, and the distal end of the actuation shaft 220 is restored to the secondarily attachable implant.

When the implant 100 is maneuvered through the actuation shaft 220, the axial stop 522 is maneuvered to release the stop of the actuation shaft 220 at the first position after the actuation shaft 220 reaches the first proximal position. When the axial stop 522 is in the first position to stop the actuation shaft 220, the actuation shaft 220 is decoupled from the control knob 521, at which point the actuation shaft 220 may be directly pulled to move axially, and more particularly proximally to a second proximal position.

In order that the actuation shaft 220 may not continue to move proximally after reaching the second proximal position, a second position is provided in the extension direction of the actuation shaft 220 corresponding to the axial stop 522, such that the axial stop 522 provides an axial stop to the actuation shaft 220 in the second position. In other words, when the actuation shaft 220 is moved to the second proximal position, the axial stop 522 provides an axial stop to the actuation shaft 220 in the second position such that the actuation shaft 220 may not continue to move proximally.

In other words, the axial stop 522 is selectively coupled to either a first position or a second position proximal to the actuation shaft 220. When the axial stop 522 is coupled to the first position, the actuation shaft 220 is axially movable between a distal position and a first proximal position under the rotation of the control knob 521. When the actuation shaft 220 is in the first proximal position and the axial stop 522 is released from the axial stop in the first position, the actuation shaft 220 can continue to move axially proximally out of the rotational action of the control knob 521 to couple the axial stop 522 to the second position such that the axial stop 522 provides an axial stop to the actuation shaft 220 in the second position. When the axial stop 522 provides axial stop to the actuation shaft 220 in the second position, the actuation shaft 220 is in the second proximal position.

Further, the actuation shaft control mechanism 520 also includes a rotation knob 584 with a rotation direction that is selectively limited, the rotation of the knob 584 effectively rotating the actuation shaft 220 relative to the implant 100, thereby allowing the implant 100 to be decoupled from the actuation shaft 220. Further, by providing a unidirectional rotation control mechanism for rotation of the knob 584, and rotating the actuation shaft 220 in a single direction, rotation of the actuation shaft 220 in a more secure direction can be prevented or inhibited, avoiding the actuation shaft 220 from locking up from coupling with the implant 100 and becoming unseparated.

Referring to fig. 5A, 5B, 10A and 10D, the actuation shaft control mechanism 520 includes a control knob 521, a push screw 523, and an axially extending cylindrical body 524. The control knob 521 is coupled to the proximal section of the handle housing 511 from the outside, the push screw 523 is coupled to the control knob 521 and the cylindrical body 524, respectively, and the proximal end of the actuation shaft 220 is fixedly coupled to the cylindrical body 524. The proximal end of cylinder 524 forms the proximal end of handle 51 and forms a knob 584, and the distal end of cylinder 524 extends axially into hollow push screw 523. The actuation shaft 220 begins at the cylindrical body 524 and then extends sequentially through the push screw 523, the control knob 521, the push rail 512, and the sheath mount 516 into the sheath 59. The proximal section of the handle housing 511 is configured with a longitudinally extending lumen for providing accommodation and clearance for the push screw 523 upon axial movement. The push screw 523 is not rotatable relative to the handle housing 511. In particular, the inner cavity of the proximal section of the handle housing 511 is provided with axially extending grooves, the distal end of the push screw 523 being provided with teeth, the groove teeth cooperating such that the push screw 523 is only axially movable relative to the handle housing 511 and not rotationally movable relative to the handle housing 511.

When the axial limiter 522 is coupled to the first position, the axial positions of the push screw 523 and the cylindrical body 524 are relatively fixed, and thus the axial positions of the push screw 523 and the actuation shaft 220 are relatively fixed, so that the actuation shaft 220 moves with the axial movement of the push screw 523. Specifically, the control knob 521 is coupled to the proximal section of the handle housing 511 from the outside and the proximal end of the control knob 521 is provided with an internal thread, and the push screw 523 is provided with an external thread capable of mating with the internal thread of the proximal end of the control knob 521. Rotation of the control knob 521 advances or retracts the push screw 523 in an axial direction, causing the push screw 523 to axially move into or out of the lumen of the proximal section of the handle housing 511, thereby causing axial movement of the actuation shaft 220. That is, when the control knob 521 is rotated about the axis of the handle 51, the rotation is translated into an axial movement of the actuation shaft 220 and effectively advances or retracts the actuation shaft 220 axially to open or close the jaws 150 of the implant (valve repair device).

Referring to fig. 10A and 10D, the push screw 523 is configured to include a small diameter section 523a and a large diameter section 523b, the small diameter section 523a providing a rotational coupling path for the control knob 521, rotation of the control knob 521 axially moving the push screw 523, thereby axially moving the actuation shaft 220 relative to the handle housing 511 and sheath 59. Large diameter section 523b provides a mounting location for axial stop 522 and the unidirectional rotation control mechanism, and the proximal end of cylinder 524 extends beyond the proximal end of large diameter section 523b, with the proximal end of cylinder 524 forming a radially enlarged knob 584. Further, the outer wall of the minor diameter section 523a is provided with a travel indicator 523c in the axial direction, the travel indicator 523c reflecting the opening angle of the distal implant 100 (opening angle of the clip 150) under the axial movement of the actuation shaft 220. Generally, in the process of controlling the opening and closing of the clamping piece of the implant through the actuating shaft 220, the actuating shafts 220 corresponding to the initial state and the end state are both located at the first proximal position. Illustratively, distal movement of the actuation shaft 220 from the first proximal position causes the jaws to progressively open, with the opening angle of the jaws of the implant being greatest (360 °) when the actuation shaft 220 is moved to the distal position, and proximal movement of the actuation shaft 220 back to the first proximal position after the leaflets are captured, with the opening angle of the jaws 150 being smallest (clasping with the coaptation element 120). More specifically, referring to fig. 10A, cylindrical body 524 is provided with an axially extending hollow lumen 582, actuation shaft 220 extends through hollow lumen 582 and the proximal end of actuation shaft 220 is secured to the proximal end of hollow lumen 582, and a stiffening section or primary stiffening tube 223 of actuation shaft 220 extends from the proximal end of hollow lumen 582 to the proximal end of sheath 59. By providing a hollow lumen 582 in cylindrical body 524, the length of the connection of first stiffening tube 233 and the proximal end of actuation shaft 220 is increased, thereby increasing the bonding area of the two and enhancing the secure connection strength of the two at the proximal end.

Referring to fig. 10A and 11A, a first position 524a and a second position 524b, when the axial stop 522 provides a stop, are provided by the cylinder 524. When the axial limiter 522 provides axial limitation in the first position 524a or the second position 524B (refer to fig. 11B and 11D), the cylindrical body 524 and the push screw 523 are relatively fixed in the axial direction. When the axial limiter 522 is released from the axial limit in the first position 524a or the second position 524b (refer to fig. 11C and 11E), the cylindrical body 524 may be axially moved relative to the push screw 523, specifically, the cylindrical body 524 may be axially moved by pulling or pushing the knob 584.

Referring to fig. 5A, 10A, and 11A to 11E, the axial stopper 522 is a stopper mechanism that can release the stopper, and is disposed on the large diameter section 523b of the push screw. The axial limiter 522 includes a push member 528, a retaining member 525 and a spring member 529, the retaining member 525 including an annular plate 525a and first and second ends 525b and 525c extending radially opposite sides from the annular plate 525a, the first end 525b of the retaining member 525 being coupled to the push member 528, the second end 525c of the retaining member 525 being coupled to the spring member 529, the spring member 529 being supported by the inner wall of the large diameter section 523b of the push screw. The cylindrical body 524 extends through the intermediate hole of the annular plate 525a, the cylindrical body 524 being provided with a first engagement portion 571a corresponding to the first position 524a and a second engagement portion 571b corresponding to the second position 524b, in particular, the first engagement portion 571a and the second engagement portion 571b each being configured as a circumferentially extending groove. The push piece 528 is disposed as an operation end of the axial stopper 522 at the top of the large diameter section 523b, and a portion of the push piece 528 is exposed above the large diameter section 523 b. More specifically, the bottom of the large diameter section 523b is provided with a receiving slot 578, and the spring member 529 sits within the receiving slot 578, with the receiving slot 578 providing support for the spring member 529. When the axial limiter 522 is in the first position 524a or the second position 524b to provide axial limitation, the pressing member 528 is in a sprung state, and the spring member 529 engages the annular plate 525a with the first engagement portion 571a or the second engagement portion 571b to limit the axial movement of the cylindrical body 524. When the axial limiter 522 is released from the axial limit at the first position 524a or the second position 524b (the axial limiter is released from the coupling with the actuation shaft from the first position or the second position), the pressing member 528 is in the pressed state, the annular plate 525a moves to one side of the spring member 529 to compress the spring member 529, and the annular plate 525a is released from the engagement with the first engagement portion 571a or the second engagement portion 571b to release the axial movement restriction of the cylinder 524, and at this time, the cylinder 524 can be directly moved axially. For example, when the annular plate 525a is released from the engagement with the first engagement portion 571a, the cylindrical body 524 is pulled proximally, the inner wall of the annular plate 525a may contact the outer wall of the cylindrical body 524 under the elastic force of the spring member 529, and when the cylindrical body 524 moves to the alignment of the second engagement portion 571b with the annular plate 525a, the annular plate 525a is engaged with the second engagement portion 571b under the elastic force of the elastic member 529, thereby achieving automatic axial limitation of the actuation shaft 220. More specifically, first position 524a is proximal to second position 524b, and the distance between first position 524a and second position 524b defines the distance between the first proximal position and the second proximal position of actuation shaft 220.

Preferably, the first engagement portion 571a is configured as a groove having a non-circular cross section. When the annular plate 525a is snapped to the first engagement portion 571a, the cylinder 524 cannot rotate, so that the actuation shaft 220 cannot rotate. When the annular plate 525a is disengaged from the first engagement portion 571a, the cylindrical body 524 is selectively rotatable in the direction.

When the control knob 521 is operated to bring the actuation shaft 220 to the first proximal position, i.e., the travel indicator 523c is aligned to the minimum scale, the axial limiter 522 is operated to disengage the annular plate 525a from the first engagement portion 571a, thereby decoupling the control knob 521 from the cylindrical body 524 (actuation shaft 220). Rotation of the knob 584 in a first direction (e.g., counter-clockwise) may then disengage the actuation shaft 220 from the implant 100. By providing a unidirectional rotation control mechanism to limit the direction of rotation of cylinder 524, it is possible to avoid the possibility of rotation in a second direction (e.g., clockwise) into a thread dead zone from disengaging when actuating shaft 220 is in a coupled state with implant 100.

Referring to fig. 5A, 10A, 12A to 12C, the one-way rotation control mechanism is specifically configured as a one-way clutch 526, the one-way clutch 526 being arranged at a position different from the axial limiter 522 on the large diameter section 523b, more specifically, the one-way clutch 526 being arranged offset in the axial direction from the axial limiter 522 with the operation ends of the two being disposed opposite to each other in the radial direction. Illustratively, the axial stop 522 is disposed proximal and upper of the large diameter section 523b and the one-way clutch 526 is disposed distal and lower of the large diameter section 523 b. The one-way clutch 526 extends radially as a whole and is axially fixed relative to the push screw 523, and an inner end of the one-way clutch 526 is configured to include asymmetric teeth, which inner end releasably abuts against a side wall of the cylindrical body 524. The section of the cylindrical body 524 where the one-way clutch 526 is abutted is configured as a spline, and spline teeth of the abutted section are configured as one-way ratchet teeth capable of engaging with the inner side end of the one-way clutch 526. More specifically, the length of the spline of cylindrical body 524 with the unidirectional ratchet is sufficient that the distal end of actuation shaft 220 is capable of unscrewing the threaded section of the distal end of implant 100 (the valve clip). When the inboard end of one-way clutch 526 is engaged to cylindrical body 524, cylindrical body 524 can be rotated in a first direction (e.g., counter-clockwise) to decouple actuating shaft 220 from implant 100 and inhibit cylindrical body 524 from rotating in a second direction (e.g., clockwise). When the inboard end of one-way clutch 526 is disengaged from cylindrical body 524, cylindrical body 524 can be rotated in a second direction to cause actuation shaft 220 to reuse the coupled implant.

With continued reference to fig. 12A and 12B, in particular, one-way clutch 526 includes a clutch knob 549, a clutch sleeve 546, a clutch shaft 527, and a clutch spring 576. The inner end of the clutch shaft 527 is configured to include asymmetric teeth, a clutch spring 576 is sleeved to the clutch shaft 527, one end of the clutch spring 576 abuts against the inner wall of the large diameter section 523b, and the other end of the clutch spring 576 abuts against the inner end of the clutch shaft 527. The clutch sleeve 546 is relatively fixed to the clutch shaft 527 in the axial direction of the clutch shaft 527, and the clutch sleeve 546 is rotatably connected to an outer end of the clutch shaft 527 about the axis of the clutch shaft 527. Clutch knob 549 is fixedly attached to clutch sleeve 546 from the outside, with the outer circumference of clutch knob 549 being provided with anti-slip features. The clutch knob 549 is configured as an operation end of the one-way clutch 526, and the clutch knob 549 is operated to radially move and rotate the clutch sleeve 546 with respect to the large diameter portion 523b of the push screw 523.

Further, referring to fig. 12C, the clutch sleeve 546 has a protrusion 547 such as a rib on the outer periphery thereof, and a notch 548 capable of engaging the protrusion 547 is provided on the peripheral side of the large diameter portion 523b of the push screw 523. When the clutch sleeve 546 rotates and moves inward into the notch 548, which seats the boss 547 outside the large diameter portion 523b, the sidewall of the notch 548 restricts the rotation of the clutch sleeve 546, and the inner end of the clutch shaft 527 engages with the cylindrical body 524 by the clutch spring 576 to allow the cylindrical body 524 to rotate only in one direction, thereby allowing the actuating shaft 220 to rotate only in one direction. When the clutch sleeve 546 is moved to the outside to the notch 548 that disengages the boss 547 from the outside of the large diameter portion 523b, the clutch spring 576 is compressed, the inner end of the clutch shaft 527 is disengaged from the cylindrical body 524, and the clutch sleeve 546 can be rotated to a non-notch that makes the clutch sleeve 546 abut against the outer periphery of the large diameter portion 523b of the push screw.

The operation of the axial limiter 522 and the one-way clutch 526 will be described.

The axial stop 522 provides an axial stop in the first position 524a with the actuation shaft 220 in threaded engagement with the implant 100. The boss 547 on the clutch collar 546 is aligned with the notch 548 on the large diameter portion 523b of the push screw 523, the boss 547 being seated in the notch 548, the sidewall of the notch 548 restricting rotation of the clutch collar 546, the inner end of the clutch collar 527 engaging the cylindrical body 524, the knob 584 being rotatable only in a first direction (counterclockwise).

Operation of the control knob 521 may advance or retract the actuation shaft 220, thereby opening (clip 150 open) or closing (clip 150 closed) the implant 100. When the actuation shaft 220 is moved proximally to the first proximal position after the leaflets are captured, the implant 100 is in the closed state and the control knob 521 is rotated relative to the push screw 523 such that the stroke of the actuation shaft to move proximally reaches a boundary and the control knob 521 is unable to move the actuation shaft 220 further proximally.

Further, depressing the pusher 528 releases the axial stop 522 from its first position 524 a. Rotating the knob 584 in a first direction (counter-clockwise) unthreads the actuation shaft 220 from the implant 100.

Further, the knob 584 is pulled proximally to move the actuation shaft 220 axially. When cylinder 524 is moved proximally to second position 524b aligned with axial stop 522, actuating shaft 220 is moved to the second proximal position and spring elements 529 return to automatically move annular plate 545 upwardly into the corresponding annular groove in second position 524b, thereby restoring axial stop 522 to axial stop of cylinder 524.

Further, the clutch knob 549 is pulled outward (downward) and rotated, so that the boss 547 on the clutch sleeve 546 is separated from the notch 548 and is displaced from the notch 548 in the rotational direction, and the engagement of the inner end of the clutch shaft 527 with the cylindrical body 524 is released. On the basis, rotating the knob 584 in a second direction (clockwise) may secondarily connect the actuating shaft 220 with the implant.

The foregoing is merely a few embodiments of the present disclosure, and those skilled in the art, based on the disclosure herein, may make various changes or modifications to the disclosed embodiments without departing from the spirit and scope of the disclosure.

Claims

1. A sheath assembly for manipulating an implant, the sheath assembly comprising:

a handle housing;

a multi-lumen tube extending distally from the handle housing;

an actuation wire having a proximal end coupled to the handle housing and a distal end coupled to the blade of the implant, the actuation wire comprising a single row of body segments extending through the multi-lumen tube and a return segment adjacent a proximal side of the body segments, and

An actuation wire control mechanism, wherein the actuation wire control mechanism includes a push-pull member axially movable relative to the handle housing, the push-pull member coupled with the reentrant section, axial movement of the push-pull member moving a clasp of the implant between an open configuration and a closed configuration;

wherein when the push-pull member moves axially, the distance by which the actuation wire is retracted or advanced is greater than the distance by which the push-pull member moves axially.

2. The sheath assembly of claim 1, wherein the proximal end of the actuation wire is releasably secured to the handle housing, the actuation wire continuing to move proximally a defined distance to disengage the distal end of the actuation wire from the blade of the implant when the proximal end of the actuation wire is unsecured from the handle housing.

3. The sheath assembly of claim 2, wherein the actuation wire control mechanism further comprises a push slide axially disposed within and fixed relative to the handle housing;

the actuating wires are configured into a pair, and the pair of actuating wires is specifically a first actuating wire and a second actuating wire;

the push-pull component comprises a first push seat, a second push seat, a first push button and a second push button, wherein the first push button is connected with the first push seat, the second push button is connected with the second push seat, and the first push button and the second push button are respectively attached to the push sliding rail in an axially movable manner;

The first pushing seat and the second pushing seat extend along the axial direction, a first connecting part is arranged on the first pushing seat, a second connecting part is arranged on the second pushing seat, the turning-back section of the first actuating wire and the turning-back section of the second actuating wire are respectively configured to comprise one-time turning-back, the proximal end of the turning-back section of the first actuating wire is attached to the first connecting part, and the proximal end of the turning-back section of the second actuating wire is attached to the second connecting part;

the first push button is configured to move axially relative to the push slide rail to drive the first push seat to move axially, and the second push button is configured to move axially relative to the push slide rail to drive the second push seat to move axially.

4. The sheath assembly of claim 3, wherein the first push button is coupled to a proximal end of the first push mount, the proximal end of the first push mount being provided with an engagement slot;

The second push button is provided with a driving shaft which radially extends towards the inside of the handle shell, the driving shaft is connected to the handle shell and rotatably penetrates through the driving shaft, and the positions of the driving shaft and the handle shell in the radial direction are relatively fixed;

when at least a part of the linkage shaft enters the joint groove, either one of the first push button and the second push button is axially shifted to enable the first push seat and the second push seat to synchronously axially move.

5. The sheath assembly of claim 4, wherein a first stop is disposed distally of the push slide and a second stop is disposed proximally of the push slide, the first and second push buttons each having a first rest position and a second rest position, the first and second stops axially moving the first and/or second push buttons between the first and second rest positions;

The axial position between the first limiting part and the second limiting part is provided with a third limiting part which can release the limiting, when the first push button or the second push button is positioned at the first stop position, the third limiting part can limit the first push button or the second push button to move proximally, and when the first push button or the second push button is positioned at the second stop position, the third limiting part can limit the first push button or the second push button to move distally.

6. The sheath assembly of claim 5, wherein the third limit is configured as a push-type spring self-locking mechanism comprising a button, a dial, a chute mechanism, a spring, a telescopic rod and a stop catch, wherein the chute mechanism is fixed relative to the handle housing and extends in a push direction of the button, the button and the dial are arranged in the push direction and are both coupled to the chute mechanism, and one side of the button away from the dial protrudes from the chute mechanism for receiving the push;

the sliding groove mechanism is provided with a long locking groove and a short locking groove, the turntable and the long locking groove can be alternatively coupled by pressing the button, when the button is in a pressed state, the turntable and the short locking groove are coupled to enable the telescopic rod to extend towards the pressing direction of the button, the stop block blocks axial movement of the push button, when the button is in a sprung state, the turntable and the long locking groove are coupled to enable the telescopic rod to retract towards the bouncing direction of the button, and the stop block does not block the axial movement of the push button.

7. The sheath assembly of claim 3, further comprising a sheath anchor, a first actuation wire retraction assembly, and a second actuation wire retraction assembly;

The sheath tube fixing seat is arranged in the handle shell and is fixed relative to the handle shell, the far end of the sheath tube fixing seat is close to the far end of the handle shell, the near end of the sheath tube fixing seat is close to the far end of the pushing slide rail, the sheath tube fixing seat is provided with a longitudinally extending inner cavity, and the first pushing seat and the second pushing seat can axially move and extend in the inner cavity of the sheath tube fixing seat;

the first actuation wire retraction assembly and the second actuation wire retraction assembly are releasably secured to laterally opposite sides of the handle housing and are both proximate the distal end of the sheath mount, the return sections of the first actuation wire and the second actuation wire both extend through the lumen of the sheath mount, the proximal end of the first actuation wire is coupled to the first actuation wire retraction assembly, and the proximal end of the second actuation wire is coupled to the second actuation wire retraction assembly;

Wherein when the first or second actuation wire retraction assembly is unsecured from the handle housing, the actuation wire may continue to move proximally to disengage the distal end of the actuation wire from the blade of the implant.

8. The sheath assembly of claim 7, wherein the first and second actuation wire retraction assemblies are each configured to include a retraction mount, a seal end cap, a retraction rod, and a retraction rod cap;

one end of the back-out fixing seat is positioned at the inner side of the handle shell and is coupled with the sheath tube fixing seat, the other end of the back-out fixing seat is positioned at the outer side of the handle shell, the sealing end cover is coupled to the back-out fixing seat from the outer side of the handle shell, and the back-out rod cap is detachably coupled to the sealing end cover;

the pull-back fixing seat is provided with an inner cavity extending along the transverse direction of the handle, one end of the pull-back rod extends into the inner cavity of the pull-back fixing seat, and the other end of the pull-back rod extends to be fixedly connected with the pull-back rod cap;

The back-out fixing seat and the sealing end cover are fixed relative to the handle shell, and when the back-out rod cap is uncoupled from the sealing end cover, the back-out rod can be driven to be far away from the sheath tube fixing seat, so that the proximal end of the actuating wire is driven to be far away from the handle shell.

9. The sheath assembly of claim 8, wherein the pullback rod and the seal cap are provided with cooperating limiting mechanisms that limit the travel distance of the pullback rod when the pullback rod is away from the sheath mount.

10. The sheath assembly of claim 9, further comprising an actuation shaft and a control knob,

The actuation shaft extends from the interior of the handle housing through the lumen of the sheath mount and then through the multi-lumen tube, the distal end of the actuation shaft being coupled to the implant;

The control knob is located at a proximal end of the push rail, the control knob is coupled to the actuation shaft, the control knob is rotatable relative to the handle housing, wherein rotation of the control knob axially moves the actuation shaft relative to the handle housing and the multi-lumen tube;

The proximal end of the sheath tube fixing seat is provided with a first group of sealing structures capable of sealing the inner cavity, the actuating shaft, the first pushing seat and the second pushing seat of the sheath tube fixing seat;

A second group of sealing structures are arranged between the sheath tube fixing seat and the back-out fixing seat and between the back-out fixing seat and the back-out rod.

11. The sheath assembly of claim 10, wherein the first and second push seats each comprise a proximal large end coupled to a corresponding push button and a distal shaft length extending distally from the large end, the large end being mated to a slide of the push rail and constrained into the lumen of the sheath holder;

The shaft length is configured in a cylindrical shape, and the length of the shaft length is greater than or equal to a distance between the first rest position and the second rest position.

12. The sheath assembly of claim 10, wherein a section of the actuation shaft within the handle housing is sleeved with a first stiffening tube fixedly coupled to the actuation shaft, the first set of sealing structures sealing the actuation shaft by sealing the first stiffening tube.

13. The sheath assembly of claim 12, wherein the distal end of the first stiffening tube is sleeved with a second stiffening tube, the proximal end of the second stiffening tube being secured to the first set of sealing structures, the distal end of the second stiffening tube extending within the lumen of the sheath mount.

14. A delivery system for delivering an implant, the delivery system comprising:

A first sheath assembly having a handle and a sheath extending from the handle in an axial direction, the sheath of the first sheath assembly having a distal end portion including a steerable section, and

A second sheath assembly according to any one of claims 1 to 13, the multi-lumen tube of the second sheath assembly extending coaxially through the sheath of the first sheath assembly;

Wherein a relative fixation mechanism is provided between the handle of the second sheath assembly and the handle of the first sheath assembly, the relative fixation mechanism extending distally from the handle housing of the second sheath assembly, the relative fixation mechanism being configured to maintain a fixed distance between the handle of the first sheath assembly and the handle of the second sheath assembly.