Sheath assemblies and delivery systems for manipulating implants

Abstract

The present invention provides a sheath assembly for manipulating an implant and a delivery system comprising the same. The sheath assembly includes a handle housing, a multi-lumen tube, an actuating shaft, and an actuating shaft control mechanism. The actuating shaft control mechanism includes a control knob and an axial limiter that can release the limit. The axial limiter can be selectively coupled to a first position or a second position located proximal to the actuating shaft. When the axial limiter is coupled to the first position, the actuating shaft can move axially between a distal position and a first proximal position under the rotation of the control knob. When the actuating shaft is at the first proximal position and the axial limit of the axial limiter at the first position is released, the actuating shaft can be disengaged from the rotation of the control knob and continue to move axially toward the proximal end until the axial limiter is coupled to the second position. The present invention lays a foundation for the secondary use of the delivery system.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and in particular to a sheath assembly and a delivery system for manipulating an implant in a heart valve repair system. Background Art

[0002] Existing heart valve repair clips all use a pre-installed design, and the clips and delivery system are assembled at the factory. One delivery system is matched with one clip. When multiple clips need to be implanted during surgery or when the device malfunctions, the entire system and clips need to be replaced. It is impossible to replace the delivery system or clip separately. Therefore, several sets of instruments of different specifications and models need to be prepared as backup during surgery, which increases the product's stocking and transportation costs. In addition, related products currently on the market generally require the withdrawal of a line running through the entire delivery system during the valve clip release phase during surgery, which not only increases the operation time but also increases the risk of bleeding. Summary of the Invention

[0003] To solve the above problems, the present invention provides a sheath assembly and a delivery system for manipulating an implant.

[0004] On the one hand, a sheath assembly for manipulating an implant includes a handle housing, a multi-lumen tubing, an actuating shaft, and an actuating shaft control mechanism. The multi-lumen tubing extends distally from the handle housing, the actuating shaft extends through the multi-lumen tubing, and the actuating shaft is configured to be coupled to the implant. The actuating shaft control mechanism includes a control knob and a releasable axial stopper. The control knob is coupled to the actuating shaft and is rotatable relative to the handle housing, wherein rotation of the control knob causes the actuating shaft to move axially relative to the handle housing and the multi-lumen tubing. The axial stopper can be selectively coupled to a first position or a second position located proximal to the actuating shaft. When the axial stopper is coupled to the first position, the actuating shaft can move axially between a distal position and a first proximal position under the action of rotation of the control knob. When the actuating shaft is in the first proximal position and the axial stopper is released from the axial limit of the first position, the actuating shaft can be freed from the rotation of the control knob and continue to move axially toward the proximal end until the axial stopper is coupled to the second position. When the axial limiter is coupled to the second position, the axial limiter provides axial limitation to the actuating shaft in the second position, and the actuating shaft is located at the second proximal position. The first position is located proximal to the second position. When the actuating shaft is located at the distal position, the opening angle of the implant is maximum. When the actuating shaft is at the first proximal position, the opening angle of the implant is minimum. When the actuating shaft is at the second proximal position, the actuating shaft and the implant are disconnected, and the distal end of the actuating shaft returns to a state where it can be reconnected to the implant.

[0005] Furthermore, the actuating shaft control mechanism also includes a push screw, which is axially movably connected to the handle housing and is axially fixed relative to the axial limiter. The push screw is threadably coupled to the control knob, so that rotation of the control knob advances or retracts the push screw in the axial direction, thereby causing axial movement of the actuating shaft.

[0006] Furthermore, the actuating shaft control mechanism further includes an axially extending cylindrical body, the proximal end of the actuating shaft being fixedly coupled to the cylindrical body, the distal end of the cylindrical body extending axially into the push screw, and the cylindrical body providing a first position and a second position. When the axial limiter is coupled to the first position or the second position, the cylindrical body and the push screw are axially fixed relative to each other. When the axial limiter is decoupled from the first position or the second position, the cylindrical body is axially movable relative to the push screw.

[0007] Furthermore, the axial limiter is arranged at the proximal end of the push screw, and the proximal end of the push screw is provided with a receiving groove. The axial limiter is constructed to include a push member, a stop member and a spring member, the stop member includes an annular plate and a first end and a second end extending from the annular plate to two radially opposite sides, the first end of the stop member is connected to the push member, the second end of the stop member is connected to one end of the spring member, and the other end of the spring member is located and abuts in the receiving groove. The cylindrical body extends through the middle hole of the annular plate, and the cylindrical body is provided with a first engagement groove corresponding to the first position and a second engagement groove corresponding to the second position. When the spring member causes the annular plate to engage with the first engagement groove or the second engagement groove, the push member is in a pop-up state, and the axial limiter is coupled to the first position or the second position. When the push member is in a pressed state, the spring member is compressed, the annular plate is disengaged from the first engagement groove or the second engagement groove, and the axial limiter is decoupled from the first position or the second position. Preferably, the cross-section of the first engagement groove is constructed as a non-circular structure.

[0008] Furthermore, the actuating shaft control mechanism also includes a one-way clutch extending radially into the push screw. The one-way clutch and the push screw are axially fixed relative to each other. The inner end of the one-way clutch is configured to include asymmetric teeth, and the inner end of the one-way clutch can releasably abut the cylindrical body. A section of the cylindrical body where the one-way clutch abuts is configured as a spline, and the spline teeth of the abutting portion are configured as one-way ratchet teeth, which can engage with the inner end of the one-way clutch. When the inner end of the one-way clutch engages with the cylindrical body, the cylindrical body can rotate in a first direction to disengage the actuating shaft from the implant and inhibit the cylindrical body from rotating in a second direction. When the inner end of the one-way clutch disengages from the cylindrical body, the cylindrical body can rotate in a second direction to reconnect the actuating shaft to the implant. The first direction is opposite to the second direction.

[0009] Specifically, the one-way clutch includes a clutch sleeve, a clutch shaft, and a clutch spring. The inner end of the clutch shaft is configured to include the asymmetric teeth. The clutch spring is sleeved onto the clutch shaft, one end of the clutch spring abuts the inner wall of the push screw, and the other end of the clutch spring abuts the inner end of the clutch shaft. The clutch sleeve and the clutch shaft are relatively fixed in the axial direction of the clutch shaft, and the clutch sleeve is rotatably connected to the outer end of the clutch shaft about the axis of the clutch shaft. The outer periphery of the clutch sleeve is provided with a protrusion, and the outer periphery of the push screw is provided with a notch capable of receiving the protrusion. When the clutch sleeve rotates and moves inward until the protrusion seats in the notch of the push screw, the inner end of the clutch shaft engages with the cylindrical body under the action of the clutch spring, and the sidewall of the notch restricts the rotation of the clutch sleeve. When the clutch sleeve moves outward until the protrusion disengages the notch of the push screw, the clutch spring is compressed, the inner end of the clutch shaft disengages from the cylindrical body, and the clutch sleeve is rotated so that it abuts the outer periphery of the push screw at a position other than the notch. Preferably, the one-way clutch further includes a clutch knob that is fixedly connected to the clutch sleeve from the outside and has an anti-slip feature on its outer periphery.

[0010] More specifically, the push screw is constructed to include a small diameter section and a large diameter section arranged in the axial direction. The small diameter section provides a rotational coupling path for the control knob. Rotation of the control knob causes the push screw to move axially, thereby causing the actuating shaft to move axially relative to the handle housing and the multi-lumen tube. The large diameter section provides a mounting location for the axial limiter and the one-way clutch. The proximal end of the cylindrical body extends beyond the proximal end of the large diameter section, and the proximal end of the cylindrical body forms a radially expanded rotary handle. Preferably, the small diameter section is provided with a stroke indicator mark along the axial direction, and the stroke indicator mark is used to indicate the opening angle of the implant.

[0011] Preferably, the cylindrical body is provided with an axially extending hollow lumen, the actuating shaft extends through the hollow lumen, and the proximal end of the actuating shaft is fixed to the proximal end of the hollow lumen. The actuating shaft is provided with a reinforcement tube outer shell, the reinforcement tube being fixedly coupled to the actuating shaft, and the reinforcement tube extending from the proximal end of the hollow lumen to the proximal end of the multi-lumen tube.

[0012] On the other hand, a delivery system for delivering an implant comprises a first sheath assembly and a second sheath assembly, wherein the second sheath assembly is the sheath assembly of the aforementioned 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, and its distal end portion includes a manipulable section. The multi-lumen tube of the second sheath assembly extends coaxially through the sheath of the first sheath assembly. A relative fixing mechanism is provided between the handle of the second sheath assembly and the handle of the first sheath assembly, the relative fixing mechanism extending distally from the handle housing of the second sheath assembly, and the relative fixing mechanism is configured to keep the distance between the handle of the first sheath assembly and the handle of the second sheath assembly fixed. Preferably, the distance between the handle of the first sheath assembly and the handle of the second sheath assembly is adjustable.

[0013] The present invention provides a reusable delivery system for replaceable valve clips, particularly a sheath assembly for manipulating an implant. This system reduces both equipment inventory and shipping costs, while also reducing operational costs, significantly benefiting patients. Furthermore, the delivery system features clearly defined modules, ergonomically designed operating areas, and an effectively integrated valve clip release mechanism, eliminating the need to remove the entire valve clip control cable. This effectively shortens surgical time and lays the foundation for secondary use of the delivery system. Specifically, the present invention provides the following benefits: 1) Greater surgical flexibility: The replaceable valve clip design allows for clip replacement as needed during surgery without replacing the entire delivery system, increasing surgical flexibility and adaptability. 2) Reduced costs and resource waste: By eliminating the need to prepare a complete system for every possible scenario, inventory and shipping costs can be reduced, while also minimizing resource waste. 3) Improved surgical efficiency: During surgery, if an instrument malfunctions or a clip of a different specification is required, it can be quickly replaced, minimizing the risk of interruption and prolonged surgery. 4) Reduced patient risk: Rapid clip replacement reduces surgical time, reducing the risk to patients of prolonged surgery. 5) Ease of operation and learning: The system is easy to operate and has a short learning curve. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0015] Figure 1 A schematic diagram of a valve repair system according to the present disclosure is shown;

[0016] Figure 2 shows a schematic diagram of a delivery system of the present disclosure;

[0017] Figure 3 A schematic diagram showing two sheath tube assemblies and a relative fixing mechanism therebetween in the delivery system of the present disclosure is shown;

[0018] Figure 4 A schematic diagram showing a sheath assembly for manipulating an actuating wire and an actuating shaft in a delivery system of the present disclosure and an implant connected thereto for manipulation is shown;

[0019] Figure 5A A perspective schematic diagram showing a handle of a sheath assembly for connecting and manipulating an actuating wire and an actuating shaft;

[0020] Figure 5B Shown Figure 5AAn exploded schematic diagram of the handle housing of the middle handle and the components connected thereto;

[0021] Figure 6A Shown Figure 5A A portion of a handle with portions of the handle housing and internal components removed, showing the basic arrangement of push-pull components for controlling axial movement of the actuating wire;

[0022] Figure 6B Shown Figure 6A An exploded diagram of the push-pull components, namely a pair of push seats and a pair of push buttons;

[0023] Figure 6C This is a schematic cross-sectional view of a pair of push buttons, taken transversely from the center of the push buttons and viewed toward the proximal end, when both push buttons are in the first rest position, illustrating the transverse connection between the pair of push buttons and the pair of push seats when the two actuating wires are independently controlled to move axially.

[0024] Figure 6D This is a schematic cross-sectional view of a pair of push buttons, taken transversely from the center of the push buttons and viewed toward the proximal end, when both push buttons are in the first rest position, illustrating the transverse connection between the push buttons and the pair of push seats when the two actuating wires are synchronously controlled to move axially.

[0025] Figure 7A and Figure 7B A three-dimensional schematic diagram and an exploded schematic diagram of the third limiting portion without the sliding groove mechanism are respectively shown;

[0026] Figure 8A Taking the second push button as an example, a longitudinal cross-sectional diagram is shown showing the positional relationship between the first limit portion, the pushing seat, and the stopper of the third limit portion when the push button is in the first rest position. For clarity, some components have been removed.

[0027] Figure 8B Taking the second push button as an example, a longitudinal cross-sectional view is shown showing the positional relationship between the second limit portion, the pushing seat, and the stopper of the third limit portion when the push button is in the second rest position. For clarity, some components have been removed.

[0028] Figure 8C and Figure 8D Schematic diagrams of the push rail viewed from the top and bottom are shown respectively;

[0029] Figure 9A Shown Figure 5A A portion of the handle with part of the handle housing removed shows the basic layout of the sheath holder;

[0030] Figure 9B A schematic transverse cross-sectional view of the connection between the sheath holder and the actuator wire retraction assembly looking toward the distal end is shown;

[0031] Figure 9C Shown Figure 5A A schematic transverse cross-sectional view of the middle handle's actuating wire retraction assembly looking toward the proximal end;

[0032] Figure 10A Shown Figure 5A A longitudinal cross-sectional view of the handle along the central axis after the actuating shaft is removed. Figure 10B Shown Figure 10A A local enlarged schematic diagram of M1 in FIG;

[0033] Figure 10C An exploded schematic diagram of the sheath holder and the first set of sealing structures is shown;

[0034] Figure 10D 1. A schematic top view of a handle of a sheath assembly for connecting and manipulating the actuating wire and the actuating shaft when the actuating shaft is located at a first proximal position;

[0035] Figure 11A Shown Figure 5A An exploded schematic diagram of a portion of the components connecting the proximal end of the middle handle and the axial limiter;

[0036] Figure 11B and Figure 11C Schematic transverse cross-sectional views looking toward the proximal end when the axial limiter provides axial limitation to the actuating shaft in the first position and releases the axial limitation are respectively shown;

[0037] Figure 11D and Figure 11E Schematic transverse cross-sectional views looking toward the proximal end when the axial limiter provides axial limitation to the actuating shaft in the second position and releases the axial limitation are respectively shown;

[0038] Figure 12A and Figure 12B Schematic cross-sectional views looking toward the proximal end are respectively shown of the one-way clutch restricting the one-way rotation of the cylindrical body and releasing the one-way rotation;

[0039] Figure 12C Shown Figure 5A Schematic diagram of the exploded view of some components connecting the proximal end of the middle handle to the one-way clutch. DETAILED DESCRIPTION

[0040] The following will be combined with the accompanying drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the embodiments described are only part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present disclosure.

[0041] When describing the present invention, "proximal" or "proximal end" refers to the direction toward the end of the device that is manipulated by the user outside the patient's body, and "distal" or "distal end" refers to the 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, linked, fixed, coupled, attached or otherwise interconnected, such interconnection may be a direct interconnection between the components, or may be an indirect interconnection, such as by using one or more intermediate components. Unless otherwise expressly limited, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions. The term "radial" refers to a direction perpendicular to the axis and pointing along a radius starting from the center of the object (with the axis at the center). The term "longitudinal section" refers to a section along the length or axial direction of the device, and the term "transverse section" refers to a section along the width or radial direction of the device. The term "inside" refers to a direction in the transverse / radial direction toward the central axis of the device. The term "outside" refers to a direction in the transverse / radial direction away from the central axis of the device.

[0042] Directional and other relative references (e.g., up, down) 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 examples shown, such terms are used, where applicable, to provide some clarity of description. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, the "upper" portion of an object can become the "lower" portion simply by flipping the object over. Nevertheless, it is still the same portion and the object remains unchanged.

[0043] The present invention provides an interventional device 10 (eg, a valve repair system) for grasping, approximating, and clamping tissue, such as a valve leaflet, to treat heart valve regurgitation, particularly mitral valve regurgitation, with reference to Figure 1 The interventional device 10 includes an implant 100 and a delivery system 20, wherein the delivery system 20 may include multiple sheath assemblies. The delivery system 20 is configured to facilitate moving the implant between its various configurations and / or implanting the implant into a native heart valve.

[0044] In some embodiments, as Figure 2 In the illustrated example, delivery system 20 includes sheath assembly 250, sheath assembly 260, and sheath assembly 270. However, in some embodiments, delivery system 20 may include fewer or more sheath assemblies than shown. In some embodiments, sheath assembly 270 is configured as a guide sheath assembly, sheath assembly 260 is configured as a steerable sheath assembly, and sheath assembly 250 is configured as an implant manipulation sheath assembly.

[0045] In some embodiments, sheath assembly 260 extends coaxially through sheath assembly 270, and sheath assembly 250 extends coaxially through sheath assembly 260 and sheath assembly 270. Implant 100 can be releasably coupled to a distal portion of sheath assembly 250.

[0046] like Figure 2 As shown in FIG, each of the sheath assemblies includes a sheath / shaft / sheath 59, 69, 79 extending from a handle 51, 61, 71, respectively. The handles 51, 61, 71 are located at the proximal end of each of the corresponding sheath / shaft / sheaths and include 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., an actuation shaft and an actuation wire extending through the sheath / shaft / sheath of the sheath assembly).

[0047] Sheath assembly 270 and sheath assembly 260 can be used, for example, to access an implantation site (e.g., the native mitral valve region of the heart) and / or position sheath assembly 250 at the implantation site. Thus, in some embodiments, sheath assembly 270 and sheath assembly 260 are both configured to be steerable (adjustable).

[0048] The sheath assembly 250 includes a handle 51, an actuating shaft 220, an actuating wire 230, and a sheath 59. The sheath 59 is configured as a multi-lumen tube. The actuating shaft 220 and the actuating wire 230 pass through the multi-lumen tube and are releasably coupled to the implant 100 from the distal side. The proximal ends of the actuating shaft 220 and the actuating wire 230 are coupled to a control member in the handle 51. The manipulation of the implant 100 by the actuating shaft 220 and the actuating wire 230 of the sheath assembly 250 can be operated in the same manner as shown and described in the Chinese patent application publication No. CN118161307A, the entire contents of which are incorporated herein by reference.

[0049] refer to Figure 3According to the delivery system 20 provided by the present invention, a relative fixing mechanism 544 is provided between the handle 51 of the sheath assembly 250 and the handle 61 of the sheath assembly 260. When an operator removes the delivery system 20 from its packaging and places it on the stabilizer, or when an operator removes the delivery system 20 for secondary loading and then places it on the stabilizer, the sheath 59 itself is relatively soft and can be easily damaged by the operator grasping one of the handles. The addition of the relative fixing mechanism 544 can protect the sheath 59. For example, the relative fixing mechanism 544 is constructed to include a sleeve 544a, a sleeve 544b, and a fastening bolt 544c. Sleeve 544a is relatively fixedly connected to the distal end of the handle 51, and sleeve 544b is relatively fixedly connected to the proximal end of the handle 61. The distal end of sleeve 544a and the proximal end of sleeve 544b are mutually nested, wherein a threaded hole is provided on the wall of the sleeve that is nested outside. The fastening bolt 544c is screwed into the threaded hole to fix 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. Specifically, the distance between the handle 51 and the handle 61 can be adjusted by adjusting the depth of the nesting of the two sleeves, that is, adjusting the distance between the distal end of sleeve 544a and the proximal end of sleeve 544b. When the distance between the distal end of sleeve 544a and the proximal end of sleeve 544b decreases, the distance between handles 51 and 61 increases; when the distance between the distal end of sleeve 544a and the proximal end of sleeve 544b increases, the distance between handles 51 and 61 decreases. By adjusting the distance between sleeve 544a and sleeve 544b, sheath assembly 250 can be moved axially relative to sheath assembly 260, thereby adjusting the relative position of the implant within the heart.

[0050] More specifically, sleeve 544a is configured as an outer sleeve, while sleeve 544b is configured as an inner sleeve. Sheath 59 extends from handle 51 through sleeve 544b and then coaxially through sheath assemblies 260 and 270. The proximal end of sleeve 544a is internally threaded, and sleeve 544a and the distal end of handle 51 are fixedly coupled via threads. A threaded hole is provided in the wall of the distal end of sleeve 544a, and a fastening bolt 544c passes through the threaded hole at the distal end of sleeve 544a to secure the two sleeves. A fixing plate is provided at the proximal end of handle 61, and the distal end of sleeve 544b is fixedly coupled to the fixing plate at the proximal end of handle 61 via threads. The proximal end of the sleeve 544b is provided with a flange structure, which matches the inner cavity size of the sleeve 544a, and the flange structure cooperates with the distal feature of the sleeve 544a to make the sleeve 544b and the sleeve 544a inseparable, thereby limiting the maximum relative movement distance between the handle 51 and the handle 61, preventing the operator from damaging the sheath 59 due to misoperation during use.

[0051] Figure 4A schematic diagram of the implant manipulation sheath assembly 250 is shown, and reference is made to Figure 1 The actuating wires 230 are configured as a pair. The sheath 59 (multi-lumen tube) has at least three longitudinally extending lumens, one of which is used to accommodate the actuating shaft 220, and the other two lumens are used to accommodate one actuating wire 230, respectively. Each actuating wire 230 is coupled to an actuating wire control mechanism 530 positioned on the handle 51, and the actuating shaft 220 is coupled to the actuating shaft control mechanism 520 positioned on the handle 51. The actuating shaft 220 can extend distally from the actuating shaft control mechanism 520, pass through the handle 51, pass through the sheath 59, and be coupled to the implant 100 at the distal end. The actuating shaft 220 is axially movable and / or rotationally movable relative to the sheath 59 and the handle 51. The actuating wire 230 can extend distally from the actuating wire control mechanism 530, pass through the handle 51 and the sheath 59, and be coupled to the clip 160 of the implant 100 at the distal end. The actuation wire 230 can move axially relative to the handle 51 and the sheath 59 , and can also move axially relative to the actuation shaft 220 .

[0052] According to the implant manipulation sheath assembly 250 provided by the present invention, the distal end of each actuating wire 230 is arranged at the distal side of the sheath 59, and the proximal end of each actuating wire 230 is arranged at the proximal side of the sheath 59. When the implant 100 is manipulated, each actuating wire 230 drives the buckle 160 of the implant 100 to move in a single-wire motion. After the implant 100 is implanted and the actuating shaft 220 and the actuating wire 230 are separated, the actuating shaft 220 and the actuating wire 230 can be maintained at the distal end of the sheath 59 for easy reuse, thereby completing the secondary connection to a new implant. It should be noted that the actuating wire in the prior art generally has a "U"-shaped structure, which has a first section extending distally from the proximal end of the delivery system and a second section that returns from the distal end of the delivery system to the proximal end along the axial length of the delivery system. The distal end and proximal end of the actuating wire are both located at the proximal side of the delivery system. The actuator wire 230 of the present disclosure is of a "monofilament" structure, which means that one end of the actuator wire 230 is at the proximal end of the delivery system 20 and the other end is at the distal end of the delivery system 20, and does not mean that the actuator wire 230 itself is a single strand or a single wire.

[0053] refer to Figure 5A and Figure 5B The handle 51 includes a handle housing 511, which can be constructed from an upper housing 511a and a lower housing 511b that can be interlocked. The interior of the handle housing 511 can provide space for multiple components. The handle housing 511 generally includes two sections along the longitudinal direction. The proximal end of the actuating wire 230 and the actuating wire control mechanism 530 are arranged and attached to the distal section of the handle housing 511, and the proximal end of the actuating shaft 220 and the actuating shaft control mechanism 520 are arranged and attached to the proximal section of the handle housing 511.

[0054] According to the sheath assembly 250 provided by the present invention, the actuator wire 230 of the "monofilament" structure includes a single-line main body segment and a return segment adjacent to the proximal side of the main body segment. The main body segment extends through the sheath 59 while the return segment does not pass through the sheath 59. The return segment is connected to the push-pull component (described in detail below) of the actuator wire control mechanism 530. The push-pull component of the actuator wire control mechanism 530 can move axially relative to the handle housing 511. The axial movement of the push-pull component can enable the buckle 160 of the implant 100 to move between an open configuration and a closed configuration. Specifically, the axial movement of the push-pull component can drive the actuator wire 230 to move axially, thereby driving the buckle 160 connected to the actuator wire 230 to move. It should be noted that the prerequisite for controlling the actuator wire 230 by the actuator 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 Figure 1 ).

[0055] According to one or more embodiments provided herein, when the push-pull member moves axially, the distance the actuator wire 230 retreats or advances is greater than the distance the push-pull member moves axially. For example, the return section of the actuator wire 230 includes only one return, and the distance the actuator wire 230 retreats or advances axially is twice the distance the push-pull member moves axially. While the actuator wire of a U-shaped loop must travel the entire length of the delivery system to fully release the clip, the actuator wire of the "monofilament" loop provided herein only needs to travel twice the distance from the clip to the distal end of the sheath 59 to fully release the clip, eliminating the need to travel the entire length of the delivery system. This effectively shortens the distance the actuator wire must be withdrawn, thereby reducing the time it takes to withdraw the actuator wire and, in turn, the surgical procedure. Furthermore, since the actuator wire does not need to be fully withdrawn from the delivery system, secondary implant loading can be achieved. The actuator wire control mechanism 530 can shorten the distance the actuator wire travels within the handle section, thereby reducing the overall size of the handle.

[0056] Optionally, the push-pull component in the actuator wire control mechanism 530 is configured to manipulate the two actuator wires 230 only simultaneously (in a linked manner); optionally, the push-pull component in the actuator wire control mechanism 530 is configured to manipulate the two actuator wires 230 only independently; preferably, the push-pull component in the actuator wire control mechanism 530 is configured to manipulate the two actuator wires 230 both independently and simultaneously (in a linked manner). According to one or more embodiments provided by the present invention, the push-pull component in the actuator wire control mechanism 530 is configured to manipulate at least the two actuator wires 230 independently.

[0057] In some embodiments, a push rail 512 is provided in the handle 51, and the push rail 512 is axially extended and arranged inside the handle housing 511 and fixed relative to the handle housing 511. The actuating wire control mechanism 530 is constructed to include an axially movable push-pull component, at least a portion of which is capable of axially moving along the push rail 512, the return section of the actuating wire 230 is attached to the push-pull component, and the actuating wire 230 moves with the axial movement of the push-pull component, thereby tightening or relaxing the actuating wire 230. Optionally, the push-pull component is constructed in a split type, and the push-pull component includes an active member (such as the second push button 532b described below) and a driven member (such as the second push seat 531b described below). Optionally, the push-pull component is constructed in an integrated type, and the push-pull component only includes an active member (such as the first push button 532a and the first push seat 531a described below).

[0058] In one embodiment, the push-pull component includes a push seat and a push button. The push button is connected to the push seat, and the actuating wire 230 is coupled to the push seat. The push button is configured to move axially relative to the push slide 512, thereby driving the push seat to move axially. The axial movement of the push seat thereby drives the actuating wire 230 to move axially.

[0059] refer to Figure 6A and Figure 6B The pushing seats are configured as a pair, both extending axially. One pushing seat is provided with a first connecting portion 533, and the other pushing seat is provided with a second connecting portion 534. The proximal end of one actuating wire 230 is attached to the first connecting portion 533, then folded back distally and fixed relative to the handle housing 511. The proximal end of the other actuating wire 230 is attached to the second connecting portion 534, then folded back distally and fixed relative to the handle housing 511. For example, the proximal end of the actuating wire can be fixed to the handle housing 511 by knotting, gluing, screwing, or riveting.

[0060] Specifically, the first connecting portion 533 and the second connecting portion 534 can be configured as a cavity, hole, groove, loop, ring, hook or other structure, which can prevent the actuating wire 230 from being disconnected from the push seat and can reduce the frictional resistance at the position where the push seat contacts the return section of the actuating wire 230 when the push seat moves axially. The first connecting portion 533 and the second connecting portion 534 can be respectively arranged at the distal end, proximal end or other suitable positions of the two push seats. Preferably, the first connecting portion 533 and the second connecting portion 534 can be respectively arranged at the distal end of the two push seats, and the stroke of the actuating wire must be sufficient to enable the two buckles to move and open 360°.

[0061] In some embodiments, the push button is configured as one, and one push button can be switchably connected to any one of the push seats, and one push button can control the axial movement of any one of the push seats or both of the push seats simultaneously. In other embodiments, the push buttons are configured as a pair, and the two push buttons can be connected to form a whole; when the two push buttons are not connected, each push button controls the axial movement of a push seat; when the two push buttons are connected, any one push button can control the axial movement of both push seats simultaneously.

[0062] Optionally, the push button is configured as one, and one push button can selectively operate one or both push seats. For example, the push button is provided with a first push seat coupling portion and a second push seat coupling portion arranged radially, and the first push seat coupling portion and the second push seat coupling portion can both selectively move radially outward to couple with corresponding push seats, thereby allowing the push button to operate one or both push seats. Pressing the push seat coupling portion can move radially, thereby coupling or decoupling the push seat coupling portion with the push seat.

[0063] Optionally, the push buttons are constructed as a pair, and the two push buttons are respectively connected to a push seat. Figure 6A and Figure 6B For ease of description, the pair of push buttons is defined as a first push button 532a and a second push button 532b, the pair of push seats is defined as a first push seat 531a and a second push seat 531b, and the pair of actuating wires 230 is defined as a first actuating wire 230a and a second actuating wire 230b. The first push button 532a is configured to move axially relative to the push rail 512, thereby driving the first push seat 531a to move axially. Axial movement of the first push seat 531a causes axial movement of the first actuating wire 230a connected thereto. The second push button 532b is configured to move axially relative to the push rail 512, thereby driving the second push seat 531b to move axially. Axial movement of the second push seat 531b causes axial movement of the second actuating wire 230b connected thereto. Preferably, the push button has a grip portion 538 that protrudes from the handle housing 511 for easier user operation.

[0064] In some embodiments, reference Figure 6BThe first push button 532a and the first push seat 531a are constructed as an integrated structure. The grip portion 538 of the first push button 532a is formed on the outer side of the proximal end of the first push seat 531a. The proximal end of the first push seat 531a is configured to include a radially extending engagement groove 535a. The second push button 532b and the second push seat 531b are constructed as separate structures. The proximal end of the second push seat 531b is configured to include a radially extending engagement hole 535b. A linkage shaft 535c is disposed in the engagement hole 535b. The second push button 532b can be selectively coupled to the second push seat 531b and the first push seat 531a via the linkage shaft 535c. Specifically, the second push button 532b is provided with a drive shaft 535d extending radially from the grip portion 538 toward the interior of the handle housing 511. The drive shaft 535d is provided with an external thread, and the linkage shaft 535c is provided with an internal thread. The drive shaft 535d is rotatably inserted into the linkage shaft 535c. Rotating the second push button 532b drives the linkage shaft 535c to move axially along the drive shaft 535d. The drive shaft 535d of the second push button 532 is restricted in radial movement by the handle housing 511 during rotation. The engagement hole 535b is configured to radially receive the linkage shaft 535c while restricting rotation of the linkage shaft 535d relative to the second push seat 531b. When the first push button 532a and the second push button 532b are axially aligned and radially aligned, the second push button 532b can be rotated in the first direction to drive the linkage shaft 535c to translate radially, and at least a portion of the linkage shaft 535c enters the engagement groove 535a, so that the first push seat 531a and the second push seat 531b are relatively fixedly connected together to form a whole. When the first push seat 531a and the second push seat 531b are connected together to form a whole, refer to Figure 6D The axial movement of any one push button can drive the two push seats 531 to move synchronously (linked), thereby driving the two actuating wires 230 to synchronously control the opening or closing of the two buckles 160 on the implant 100. Furthermore, the second push button 532b can rotate in the second direction to drive the linkage shaft 535c to disengage the engagement groove 535a, so that the first push seat 531a and the second push seat 531b can be restored to independence, thereby allowing the two actuating wires 230 to independently control the opening or closing of the two buckles 160 on the implant 100. Figure 6C For example, the first direction is the counterclockwise direction when viewed from the second push button 532b to the first push button 532a, and the second direction is the clockwise direction when viewed from the second push button 532b to the first push button 532a.

[0065] Further, refer to Figure 5AEach push button has a first stop position and a second stop position. The first stop position corresponds to the axial movement of the actuating wire 230 causing the buckle 160 to move away from the mating element 120 to be in an open configuration. The second stop position corresponds to the axial movement of the actuating wire 230 causing the buckle 160 to move close to the mating element 120 to be in a closed configuration (e.g., Figure 1 Specifically, a first limiting portion is arranged on the distal side of the push rail 512, and the first stop position of the push knob is at least limited by the first limiting portion; a second limiting portion is arranged on the proximal side of the push rail 512, and the second stop position of the push knob is at least limited by the second limiting portion.

[0066] In some embodiments, the first limit portion and the second limit portion can be provided by design features on the handle housing 511, corresponding to the axial travel of the push button defined between the first stop position and the second stop position. Specifically, the side wall of the handle housing 511 is provided with side features suitable for the axial movement and stop of the grip portion 538, for example, Figure 5A As shown, an open slot 511c is provided on the side of the handle housing 511 to allow the push button to move axially. The push button extends through the open slot 511c to connect to the push seat. A portion of the handle housing 511 is flattened along the length of the open slot 511c to mate with the mating surface of the grip portion 538, facilitating smoother movement of the push button. The width of the open slot 511c is configured to be larger than the diameter of the coupling shaft between the grip portion 538 and the push seat, but smaller than the transverse dimension of the grip portion 538 itself. The first and second limit portions 513, 514 are provided at either end of the length of the open slot 511c.

[0067] In some embodiments, the first limit portion and the second limit portion may be provided by components within the handle housing 511, corresponding to the axial travel of the push button defined between the first rest position and the second rest position. Figure 6A The push rail 512 provided according to the present invention is generally constructed in the shape of a flat plate, and the push button and the push seat move axially along the bottom surface of the push rail 512. Optionally, a protrusion can be provided on the bottom surface of the distal end and the proximal end of the push rail 512, respectively, and the protrusion can limit the axial movement of either the push button or the push seat. The protrusions at the distal and proximal ends provide a first limiting portion and a second limiting portion. Optionally, a component similar to a baffle can be added to the distal end and the proximal end of the push rail 512, respectively, and the baffle can limit the axial movement of either the push button or the push seat. The baffles at the distal and proximal ends provide a first limiting portion and a second limiting portion.

[0068] In some embodiments, corresponding to the axial travel of the push button defined between the first and second resting positions, the first and second limit portions may be provided by both design features of the handle housing 511 itself and components within the handle housing 511; or, one of the first and second limit portions may be provided by design features of the handle housing 511 itself, while the other may be provided by components within the handle housing 511. The specific implementation is similar to the aforementioned implementation and will not be further described.

[0069] Furthermore, a third limiting portion, capable of releasing the limiting action, is disposed axially between the first limiting portion and the second limiting portion. When the push button is in the first rest position, the third limiting portion is activated to restrict proximal movement of the push button, thereby preventing accidental operation of the push button from changing the state of the clasp 160, which has been adjusted to the open configuration. When the push button is in the second rest position, the third limiting portion is activated to restrict distal movement of the push button, thereby preventing the push button from being pulled distally by the tensioned actuating wire 230 and changing the state of the clasp 160, which has been adjusted to the closed configuration. When the third limiting portion is released, the push button can move from the first rest position to the second rest position or from the second rest position to the first rest position.

[0070] In some embodiments, reference Figure 5A 、 Figure 5B 、 Figure 7A and Figure 7B The third limiting portion 515 is configured as a push-type spring self-locking structure, comprising a button 53, a rotating disk 582, a slide mechanism 581, a first spring 583a, a telescopic rod 561, and a stopper 562. The slide mechanism 581 is fixed relative to the upper housing 511a and extends in the direction in which the button 53 is pressed. Optionally, the slide mechanism 581 is integrally formed with the upper housing 511a. The button 53 and the rotating disk 582 are arranged along the pressing direction and are both coupled to the slide mechanism 581. The side of the button 53 facing away from the rotating disk 582 protrudes from the slide mechanism 581 to facilitate receiving a press. One end of the first spring 583a abuts the rotating disk 582, while the other end of the first spring 583a abuts the push rail 512. One end of the telescopic rod 561 is coupled to the rotating disk 582, while the other end of the telescopic rod 561 is coupled to the stopper 562. Optionally, the telescopic rod 561 and the stopper 562 are integrally formed.

[0071] Preferably, the third limiting portion 515 further includes a stopper 586a and a second spring 583b. A slot 586b is provided at the upper end of the telescopic rod 561. The stopper 586a is positioned within the slot 586b and abuts the upper surface of the turntable 582. The upper end of the telescopic rod 561 is coupled to the turntable 582 via the stopper 586a. The first spring 583a abuts between the lower surface of the turntable 582 and the upper surface of the push rail 512. The second spring 583b abuts between the turntable 582 and the telescopic rod 561. The second spring 583b cooperates with the stopper 586a to integrally couple the turntable 582 and the telescopic rod 561. The provision of the stopper 586a and the second spring 583b facilitates installation of the third limiting portion 515.

[0072] Button 53 is provided with a first tooth 584 for pushing rotating disk 582. Rotating disk 582 is also provided with a second tooth 585. Sliding slot mechanism 581 is provided with alternating long and short locking slots. Pressing the button causes rotating disk 582 to alternately engage with the long and short locking slots. Accordingly, when the second tooth 585 of rotating disk 582 engages with the short locking slot, button 53 is in a depressed state; when the second tooth 585 of rotating disk 582 engages with the long locking slot, button 53 is in an up state.

[0073] Pressing the button 53 causes the stopper 562 of the third limiting portion 515 to move in the pressing direction, thereby causing the stopper 562 to restrict or release the axial movement of the push-pull component. Specifically, when the button 53 is pressed, the telescopic rod 561 extends in the direction in which the button 53 is pressed. The stopper 562 is driven by the telescopic rod 561 into the path of the push-pull component (the push button and / or the push seat), thereby blocking the axial movement of the push-pull component. Pressing the button 53 again causes the button 53 to be released, and the telescopic rod 561 retracts in the direction in which the button 53 was released. The stopper 562 is driven by the telescopic rod 561 out of the path of the push-pull component (the push button and / or the push seat), thereby blocking the axial movement of the push-pull component.

[0074] Specifically, for the configuration of a pair of push seats and a pair of push buttons, the stopper 562 is constructed to include a pair of axially extending blocks 562a and 562b, which are connected by a crossbeam 562c, so that the stopper 562 as a whole forms an I-shaped member. The telescopic rod 561 is specifically connected to the crossbeam 562c of the stopper 562. The block 562a is used to define the position of the first push button 532a and / or the first push seat 531a, and the block 562b is used to define the position of the second push button 532b and / or the second push seat 531b. The axial lengths of the blocks 562a and 562b must meet the following requirements: the distal ends of the blocks 562a and 562b extend to an axial position that can stabilize the push buttons in the first rest position, and the proximal ends of the blocks 562a and 562b extend to an axial position that can stabilize the push buttons in the second rest position.

[0075] More specifically, refer to Figure 6B The push seat includes a large end portion 537a at the proximal end and an axial length portion 537b extending from the large end portion to the distal end. The large end portion 537a has a distal side surface 537c and a proximal side surface 537d that are oppositely arranged. The lateral dimension of the distal side surface 537c is larger than that of the axial length portion 537b. Figure 8A When the second push button 532b is located at the first stop position and the third limiting portion 515 is in the limiting position, at least a portion of the proximal side surface 537d is blocked by the distal end of the stopper 562b; Figure 8B When the second push button 532b is located at the second stop position and the third limiting portion 515 is limited, at least a portion of the distal surface 537c is blocked by the proximal end of the stop block 562b.

[0076] More specifically, refer to Figure 8C The push rail 512 is constructed as a flat plate. A receiving space 557 is provided in the middle of the push rail 512 for accommodating the stopper 562. The positions corresponding to the stoppers 562a and 562b in the receiving space 557 are configured to be vertically continuous. When the telescopic rod 561 is extended in the direction of pressing the button 53, the stoppers 562a and 562b can move downward from the receiving space 557 until the lower surfaces of the stoppers 562a and 562b pass over the lower surface of the push rail 512, thereby forming an obstacle on the axial travel path of the push button and / or the push seat (refer to FIG. Figure 8A and Figure 8BWhen the telescopic rod 561 retracts in the direction in which the button 53 pops up, the stops 562a and 562b can move upward from the accommodating space 557 until the lower surfaces of the stops 562a and 562b pass over the top of the large end portion 537a, thereby eliminating any obstruction to the travel path of the push button and / or push seat. The button 53 of the third limiting portion 515 is attached to the outer wall of the upper housing 511a, and the telescopic rod 561 extends from the button 53 through the upper housing 511a into the accommodating space 557. Furthermore, the accommodating space 557 is provided with a non-button-side mating feature 559 that mates with the push-type spring self-locking structure, such as a spring mating feature or a telescopic rod mating feature.

[0077] In some embodiments, the large end portion 537a is configured as a square body, and the upper surface of the square body can smoothly move axially along the bottom surface of the flat push rail 512. In order to cooperate with the axial movement of the large end portion 537a of the square body, preferably, reference Figure 8D Corresponding to the axial stroke of the push button defined between the first stop position and the second stop position, a longitudinally extending partition 556 is provided at the bottom of the push slide 512. The partition 556 forms two slideways 558a and 558b at the bottom of the push slide 512. Figure 6C Within the sliding space of the large end portion 537a, the outer wall of the divider 556 and the inner wall of the handle housing 511 are both constructed as flat surfaces suitable for translational movement of the cube wall. Furthermore, the proximal and distal ends of the push rail 512 and the divider 556 are equipped with structural features suitable for mounting the actuating shaft 220 and the reinforcement tube.

[0078] refer to Figures 9A to 9C The handle 51 is also provided with a sheath holder 516. The sheath holder 516 extends axially within the handle housing 511 and is fixed relative to the handle housing 511. The proximal end of the sheath 59 is fixedly coupled to the distal end of the sheath holder 516. More specifically, the sheath holder 516 is located at the distal end of the push slide 512 and is fixed relative to the push slide 512. The sheath holder 516 is configured to have at least a longitudinally extending inner lumen 517. The inner lumen 517 of the sheath holder 516 provides a movable space and a receiving space for the portion of the proximal end of the actuating wire 230 that can be axially moved by the push-pull component. In other words, it provides a movable space and a receiving space for the portion of the push-pull component coupled to the actuating wire 230. In addition, the inner lumen 517 of the sheath holder 516 also provides a passage for the actuating shaft 220 to extend through.

[0079] In a specific embodiment, the inner cavity 517 of the sheath fixing seat 516 includes a first sub-cavity 517a, a second sub-cavity 517b, and a transition cavity 517c therebetween. The transition cavity 517c connects the first sub-cavity 517a with the second sub-cavity 517b from the upper side. A longitudinally extending partition 517d is provided between the first sub-cavity 517a and the second sub-cavity 517b. The partition 517d separates the first sub-cavity 517a and the second sub-cavity 517b laterally. The first sub-cavity 517a can provide a movable space and a storage space for the first push seat 521a corresponding to the stroke, and the second sub-cavity 517b can provide a movable space and a storage space for the second push seat 521b corresponding to the stroke. The actuating shaft 220 in the handle 51 extends into the sheath 59 via the transition cavity 517c. The proximal end of the first actuating wire 230a extends in the first sub-cavity 517a to be connected to the first connecting portion 533 and is bent back in the distal direction to be fixed to one lateral side of the handle housing 511. The proximal end of the second actuating wire 230b extends in the second sub-cavity 517b to be connected to the second connecting portion 534 and is bent back in the distal direction to be fixed to the other lateral side of the handle housing 511.

[0080] More specifically, when the push button is in the first stop position, Figure 8A 、 Figure 9A 、 Figure 9B and Figure 10A , the majority of the shaft length 537b (towards the distal end) is located in the inner cavity 517, and the large end 537a is located in the space defined by the push rail 512 and the lower shell 511b. Figure 8B Only the distal end of the axial length portion 537b is located in the inner cavity 517, and most of the axial length portion 537b (near the side) and the large end portion 537a are located in the space defined by the pushing slide rail 512 and the lower shell 511b.

[0081] Furthermore, according to the sheath assembly 250 provided by the present invention, the proximal end of the actuating wire 230 is releasably fixed to the handle housing 511. Corresponding to the proximal ends of the pair of actuating wires 230 being fixed at the lateral sides of the handle housing 511, the handle 51 further provides a pair of actuating wire retraction assemblies. Figure 5A 、 Figure 6A and Figure 9CA first actuating wire retraction assembly 518a is fixed to one lateral side of the handle housing 511. The proximal end (outer end of the return section) of the first actuating wire 230a is coupled to the first actuating wire retraction assembly 518a. The first actuating wire retraction assembly 518a is configured to pull the proximal end of the first actuating wire 230a outwardly away from the handle housing 511. A second actuating wire retraction assembly 518b is fixed to the other lateral side of the handle housing 511. The proximal end (outer end of the return section) of the second actuating wire 230b is coupled to the second actuating wire retraction assembly 518b. The second actuating wire retraction assembly 518b is configured to pull the proximal end of the second actuating wire 230b outwardly away from the handle housing 511. When the proximal end of the first actuating wire 230a or the proximal end of the second actuating wire 230b is pulled away from the handle housing 511, the push button coupled to the corresponding actuating wire is located in a second rest position. For example, when the two actuating wires 230 are independently manipulated to move axially, the proximal end of the first actuating wire 230a is pulled away from the handle housing 511 when the first push button 532a is in the second rest position, and the proximal end of the second actuating wire 230b is pulled away from the handle housing 511 when the second push button 532b is in the second rest position. After the implant 100 is in the closed configuration, the distal end of the actuating wire 230 can be disconnected from the clasp 160 by pulling the proximal end of the actuating wire 230 away from the handle housing 511, thereby disconnecting the implant 100 and completing the implantation procedure. Because the distal end of the actuating wire 230 is provided with a retaining feature that engages with the distal end of the sheath 59, the distance the proximal end of the actuating wire 230 can be pulled away from the handle housing 511 is limited, thereby ensuring that the distal end of the actuating wire 230 is confined to the distal side of the sheath 59 so that it can be reconnected to the clasp 160 when the implant is reloaded.

[0082] refer to Figure 9CEach actuator wire retraction assembly includes a retraction fixing seat 563, a sealing end cap 564, a retraction rod 565, and a retraction rod cap 566. The retraction fixing seat 563 extends in the transverse direction. One end of the retraction fixing seat 563 is located inside the handle housing 511 and is coupled to the sheath tube fixing seat 516. The other end of the retraction fixing seat 563 is located outside the handle housing 511. The sealing end cap 564 is connected to the retraction fixing seat 563 from the outside of the handle housing 511. The retraction rod cap 566 is detachably connected to the sealing end cap 564. Specifically, the retraction fixing seat 563 and the sheath tube fixing seat 516 can be sealed by threading, gluing, ultrasonic welding, or integral molding. The retraction mount 563 has an inner cavity extending transversely to the handle 51. One end of a retraction rod 565 extends into the inner cavity of the retraction mount 563, while the other end of the retraction rod 565 extends outside the sealing end cap 564 and is fixedly coupled to a retraction rod cap 566. For example, the retraction rod 565 and the retraction rod cap 566 are fixedly connected by means of a snap connection, adhesive bonding, or ultrasonic welding. The proximal end of the actuating wire 230 is distally folded back to the retraction mount 563, passes through the inner cavity of the retraction mount 563, and is fixedly coupled to the retraction rod 565. The retraction mount 563 and the sealing end cap 564 are fixed relative to the handle housing 511. When the retraction rod cap 566 is disconnected from the sealing end cap 564, the retraction rod 565 is driven away from the sheath mount 516, thereby driving the proximal end (the outer end of the folded section) of the actuating wire 230 away from the handle housing 511. Preferably, the inner end of the withdrawal rod 565 is configured as a flange structure, and the outer end of the withdrawal rod 565 is fixedly connected to the withdrawal rod cap 566. The outer end of the sealing end cap 564 provides a movable channel for the withdrawal rod 565 with a cross-sectional dimension smaller than the cross-sectional dimension of the flange structure of the withdrawal rod 565. When the withdrawal rod cap 566 is operated to pull away from the withdrawal rod 565 and move outward, the flange structure of the withdrawal rod 565 is restricted by the outer end of the sealing end cap 564, and the pulling stops. In other words, the withdrawal distance of the withdrawal rod 565 is limited, which can prevent accidental operation from damaging the connection between the actuating wire 230 and the distal end of the sheath tube 59.

[0083] Further, refer to Figure 10C The top of the sheath tube fixing seat 516 is provided with a Luer interface 555 connected to the inner cavity 517, and the Luer interface 555 is externally connected to the one-way Luer 519. For example, the one-way Luer 519 is directly bonded to the Luer interface 555 to achieve a one-way exhaust seal of the sheath tube fixing seat 516 and the sheath tube 59.

[0084] In the longitudinal connection direction of the sheath tube fixing seat 516, a first set of sealing structures for sealing the actuating shaft 220 and the push-pull component is provided at the proximal end of the inner cavity 517. 10A to 10CThe first set of sealing structures is arranged at the connection between the distal end of the push slide 512 and the proximal end of the sheath fixing seat 516. The first set 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 tops of the sheath fixing seat 516, the first cover plate 551, and the second cover plate 552 are basically flush, and the three are sealed and connected in the axial direction by the silicone sealing sheet 541a, the first O-ring 541b, and the second O-ring 541c. The first set of sealing structures achieves axial sealing of the entire cavity of the sheath fixing seat 516, and also achieves sealing of the actuating shaft 220 or the first reinforcing tube 223 (described later, in which the actuating shaft 220 extends) and the axial length portion 537b. Furthermore, to ensure effective axial sealing, the length of the axial length portion 537b of the push seat is configured to be greater than or equal to the distance between the first and second resting positions (the maximum axial travel of the push-pull component). In particular, the first connecting portion 533 and the second connecting portion 534 are respectively disposed at the distal ends of the two push seats, completely inserting the proximal section of the actuating wire 230 into the cavity of the sheath fixing seat 516. This can transform the sealing of the wire into a sealing of the axial length section of the push seat, thereby improving sealing performance.

[0085] The proximal end of the sheath holder 516 is configured to have a recessed area 516a (see Figure 10C ), the silicone sealing sheet 541a can be seated within the recessed area 516a, and the outer shape of the silicone sealing sheet 541a is configured to substantially conform to the transverse profile of the sheath holder 516. The first cover plate 551 presses the silicone sealing sheet 541a from the proximal side and is connected to the proximal end of the sheath holder 516. The first cover plate 551 includes two side channels 551b suitable for the passage of the push seat and a central channel 551a suitable for the passage of the actuating shaft 220. The central channel 551a is preferably provided by an axially extending cylindrical body that can be received by the transition cavity 517c without interfering with the axial movement of the two push seats. The proximal ends of the two side channels 551b are respectively provided with recessed steps 551c suitable for the first O-ring 541b to be seated therein, and the proximal end of the central channel 551a is provided with a recessed step 551d suitable for the second O-ring 541c to be seated therein. The second cover plate 552 presses the two first O-rings 541b and the second O-ring 541c from the proximal side and simultaneously provides an extension channel for the push seat and the actuating shaft 220. Preferably, the first sealing assembly is connected together by tightening bolts 543 and placed in the handle housing 511 after the first sealing assembly is fully assembled.

[0086] Furthermore, in the transverse connection direction of the sheath tube fixing seat 516, a second set of sealing structures is provided for each actuating wire retraction assembly. Figure 9CA silicone sealing gasket 542a is provided at the coupling between the retraction mount 563 and the sheath mount 516. A third O-ring 542b is provided between the retraction rod 565 and the retraction mount 563 within the inner cavity of the retraction mount 563. This second set of sealing structures seals the entire cavity of the sheath mount 516 in the transverse direction, while also sealing the actuating wire.

[0087] The sheath tube holder 516 with an inner cavity structure first provides a connection / fixing position for the sheath tube 59, and secondly provides an exhaust interface for the gas in the sheath tube 59. In addition, it also provides an interface, movable space or accommodation space for the fixation / axial movement of the proximal end of the actuator wire itself, the axial movement of the push-pull component connected to the actuator wire, and the axial movement of the actuator shaft. On this basis, only basic sealing O-rings and sealing cover plates are provided at the connection between the sheath tube holder 516 and the push slide 512, and at the connection with the actuator wire retraction component, so as to achieve effective sealing of the small-diameter actuator shaft (or its outer reinforced tube) and the actuator wire. At the same time, it is convenient to install and simple to operate, and the overall structure of the handle 51 is simplified.

[0088] refer to Figure 6A and Figure 10A The actuating shaft 220 in the handle 51 is sheathed with a first reinforcing tube 223. A second reinforcing tube 225 is also sheathed within a section located within the lumen 517 of the sheath holder 516. Specifically, the second reinforcing tube 225 is sheathed within the distal section of the first reinforcing tube 223. More specifically, the second reinforcing tube 225 is disposed within the lumen of the sheath holder 516. The first reinforcing tube 223 is axially movable within the second reinforcing tube 225. Both reinforcing tubes simultaneously support and reinforce the actuating shaft 220. Alternatively, the reinforcing tubes may be omitted, and the strength of the section of the actuating shaft 220 located within the handle 51 may be adjusted to be greater than that of the other section of the actuating shaft extending within the sheath 59. Specifically, the material of both reinforcing tubes may be medical-grade stainless steel. The proximal end of the first reinforcing tube 223 is riveted, bonded, or welded to the actuating shaft 220 at the proximal end of the handle 51. The proximal end of the first reinforcing tube 223 and the actuating shaft 220 at the proximal end of the handle 51 are bonded or integrally injection-molded together and fixed within the hollow, narrow cavity 582 (described below) of the cylindrical body 524. The second reinforcing tube 225 is bonded or integrally injection-molded to the cavity extending from the first cover plate 551.

[0089] Extending the first reinforcement tube 223 into the cylindrical body 524 and into the handle 584 facilitates sealing of the first reinforcement tube. Specifically, in the first sealing assembly, the second O-ring 541c seals the first reinforcement tube 223, thereby sealing the actuating shaft 220. Because the diameter of the actuating shaft 220 is smaller than that of the first reinforcement tube 223 and the actuating shaft 220 requires axial movement, the first reinforcement tube 223 increases the sealing dimension at this point, achieving a better sealing effect.

[0090] refer to Figure 5A and Figure 5B The actuation shaft control mechanism 520 provided herein generally comprises a manipulation component, assembly, or mechanism capable of longitudinally moving the actuation shaft 220, thereby enabling movement of the clip 150 of the implant 100 between an open position and a closed position. Specifically, the actuation shaft control mechanism 520 comprises a control knob 521 coupled to the actuation shaft 220. The control knob 521 is rotatable relative to the handle housing 511, wherein rotation of the control knob 521 causes the actuation shaft 220 to axially move relative to the handle housing 511 and the sheath 59.

[0091] Furthermore, a control knob 521 is rotatably coupled to the handle housing 511, and the control knob 521 is selectively coupled to the actuation shaft 220. When the control knob 521 is coupled to the actuation shaft 220, rotating the control knob 521 can cause the actuation shaft 220 to move axially 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 can be independently operated, for example, by manually pulling the actuation shaft 220 to continue moving proximally.

[0092] Furthermore, the actuating shaft control mechanism 520 also includes an axial limiter 522 that can release the limit. During the process of manipulating the opening and closing of the clip of the implant 100 by the actuating shaft 220 until the actuating shaft 220 and the implant 100 are completely separated after implantation, the axial limiter 522 provides axial limit for the actuating shaft 220 in a first position and a second position. The first position and the second position are arranged proximal to the actuating shaft 220, and the first position and the second position are axially spaced, with the first position being proximal to the second position. When the axial limiter 522 provides axial limit for the actuating shaft 220 in the first position, the actuating shaft 220 can move axially between the distal position and the first proximal position under the rotation of the control knob 521. When the axial limiter 522 provides axial limit for the actuating shaft 220 in the second position, the position of the actuating shaft 220 is fixed at the second proximal position. Among them, when the actuating shaft 220 is located at the distal position, the clip 150 of the implant 100 is in a fully open state (the opening angle is maximum, 360°); when the actuating shaft 220 is located at the first proximal position, the clip 150 of the implant 100 is in a closed state; when the actuating shaft 220 is located at the second proximal position, the actuating shaft 220 and the implant 100 are in a disconnected state, and the distal end of the actuating shaft 220 is restored to a state where it can be reconnected to the implant.

[0093] When the implant 100 is manipulated by the actuating shaft 220, after the actuating shaft 220 reaches the first proximal position, the axial stopper 522 needs to be manipulated to release the limit on the actuating shaft 220 at the first position. When the axial stopper 522 releases the limit on the actuating shaft 220 at the first position, the actuating shaft 220 is decoupled from the control knob 521. At this time, the actuating shaft 220 can be directly pulled to move axially, more specifically, to move axially proximally to the second proximal position.

[0094] To prevent the actuating shaft 220 from further proximally moving after reaching the second proximal position, a second position is provided corresponding to the axial stopper 522 in the extending direction of the actuating shaft 220, so that the axial stopper 522 provides axial restraint for the actuating shaft 220 at the second position. In other words, when the actuating shaft 220 moves to the second proximal position, the axial stopper 522 provides axial restraint for the actuating shaft 220 at the second position, preventing the actuating shaft 220 from further proximally moving.

[0095] In other words, the axial stopper 522 can be selectively coupled to a first position or a second position proximal to the actuating shaft 220. When the axial stopper 522 is coupled to the first position, the actuating shaft 220 can move axially between the distal position and the first proximal position under the rotation of the control knob 521. When the actuating shaft 220 is in the first proximal position and the axial restriction of the axial stopper 522 in the first position is released, the actuating shaft 220 can be freed from the rotation of the control knob 521 and continue to move axially proximally until the axial stopper 522 is coupled to the second position, so that the axial stopper 522 provides axial restriction for the actuating shaft 220 in the second position. When the axial stopper 522 provides axial restriction for the actuating shaft 220 in the second position, the actuating shaft 220 is in the second proximal position.

[0096] Furthermore, the actuating shaft control mechanism 520 further includes a handle 584 whose rotation direction can be selectively limited. Rotation of the handle 584 effectively rotates the actuating shaft 220 relative to the implant 100, thereby separating the implant 100 from the actuating shaft 220. Furthermore, a one-way rotation control mechanism is provided for the rotation of the handle 584, which rotates the actuating shaft 220 in a single direction, thereby preventing or inhibiting the actuating shaft 220 from rotating in a more secure direction, thereby preventing the actuating shaft 220 from being locked in its connection with the implant 100 and unable to be separated.

[0097] refer to Figure 5A 、 Figure 5B 、 Figure 10A and Figure 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 externally coupled to the proximal section of the handle housing 511. The push screw 523 is coupled to both the control knob 521 and the cylindrical body 524. The proximal end of the actuation shaft 220 is fixedly coupled to the cylindrical body 524. The proximal end of the cylindrical body 524 forms the proximal end of the handle 51 and forms a knob 584. The distal end of the cylindrical body 524 extends axially into the hollow push screw 523. The actuation shaft 220 originates from 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 before entering the sheath 59. The proximal section of the handle housing 511 is configured with a longitudinally extending internal cavity to accommodate and accommodate the push screw 523 during axial movement. The push screw 523 cannot rotate relative to the handle housing 511. Specifically, the inner cavity of the proximal section of the handle housing 511 is provided with an axially extending groove, and the distal end of the push screw 523 is provided with a protruding tooth. The groove and teeth cooperate to enable the push screw 523 to only move axially relative to the handle housing 511 but not to rotate relative to the handle housing 511.

[0098] 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 actuating shaft 220 are relatively fixed, so that the actuating shaft 220 moves in response to the axial movement of the push screw 523. Specifically, the control knob 521 is externally coupled to the proximal section of the handle housing 511, 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 that can cooperate with the internal thread of the proximal end of the control knob 521. Rotating the control knob 521 advances or retracts the push screw 523 in the axial direction, causing the push screw 523 to axially enter or exit the inner cavity of the proximal section of the handle housing 511, thereby causing axial movement of the actuating shaft 220. That is, when the control knob 521 rotates about the axis of the handle 51, the rotation is converted into axial movement of the actuation shaft 220 and effectively axially advances or retracts the actuation shaft 220 to open or close the clips 150 of the implant (valve repair device).

[0099] refer to Figure 10A and Figure 10D The push screw 523 is constructed to include a small-diameter section 523a and a large-diameter section 523b. The small-diameter section 523a provides a rotational coupling path for the control knob 521. Rotation of the control knob 521 causes axial movement of the push screw 523, thereby causing axial movement of the actuating shaft 220 relative to the handle housing 511 and the sheath 59. The large-diameter section 523b provides a mounting location for the axial limiter 522 and the one-way rotation control mechanism. The proximal end of the cylindrical body 524 extends beyond the proximal end of the large-diameter section 523b, forming a radially enlarged rotary handle 584. Furthermore, the outer wall of the small-diameter section 523a is provided with travel indicator marks 523c along the axial direction. The travel indicator marks 523c reflect the opening angle of the distal implant 100 (the opening angle of the clip 150) under the action of axial movement of the actuating shaft 220. Generally, in the process of manipulating the opening and closing of the clip of the implant by the actuating shaft 220, the actuating shaft 220 corresponding to the initial state and the end state is located at the first proximal position. For example, the actuating shaft 220 moves from the first proximal position to the distal end to gradually open the clip. When the actuating shaft 220 moves to the distal position, the opening angle of the clip of the implant is the largest (360°); after capturing the leaflet, the actuating shaft 220 moves proximally back to the first proximal position. At this time, the opening angle of the clip 150 is the smallest (engaged with the matching element 120). More specifically, referring to Figure 10AThe cylindrical body 524 is provided with an axially extending hollow lumen 582. The actuating shaft 220 extends through the hollow lumen 582 and the proximal end of the actuating shaft 220 is fixed to the proximal end of the hollow lumen 582. The reinforcing section or first reinforcing tube 223 of the actuating shaft 220 extends from the proximal end of the hollow lumen 582 to the proximal end of the sheath tube 59. The provision of the hollow lumen 582 in the cylindrical body 524 increases the connection length between the first reinforcing tube 233 and the proximal end of the actuating shaft 220, thereby increasing the bonding area between the two and strengthening the fixed connection strength at the proximal end.

[0100] refer to Figure 10A and Figure 11A The first position 524a and the second position 524b of the axial stopper 522 are both provided by the cylindrical body 524. When the axial stopper 522 provides axial limitation in the first position 524a or the second position 524b (refer to Figure 11B and Figure 11D ), the cylindrical body 524 and the pushing screw 523 are relatively fixed in the axial direction. When the axial limiter 522 is released from the axial limit at the first position 524a or the second position 524b (refer to Figure 11C and Figure 11E ), the cylindrical body 524 can move axially relative to the pushing screw 523. Specifically, the cylindrical body 524 can move axially by pulling or pushing the handle 584.

[0101] refer to Figure 5A 、 Figure 10A 、 Figures 11A to 11EThe axial limiter 522 is a releasable limit mechanism, arranged on the large-diameter section 523b of the push screw. The axial limiter 522 includes a push member 528, a stop member 525, and a spring member 529. The stop member 525 includes an annular plate 525a and a first end 525b and a second end 525c extending from the annular plate 525a to opposite radial sides. The first end 525b of the stop member 525 is connected to the push member 528, and the second end 525c of the stop member 525 is connected to the spring member 529. The spring member 529 is supported by the inner wall of the large-diameter section 523b of the push screw. The cylindrical body 524 extends through the central hole of the annular plate 525a. The cylindrical body 524 is provided with a first engaging portion 571a corresponding to the first position 524a and a second engaging portion 571b corresponding to the second position 524b. Specifically, the first engaging portion 571a and the second engaging portion 571b are each configured as a circumferentially extending groove. The push member 528, serving as the operating end of the axial limiter 522, is arranged at the top of the large-diameter section 523b, with a portion of the push member 528 exposed above the large-diameter section 523b. More specifically, the bottom of the large-diameter section 523b is provided with a receiving groove 578, in which the spring member 529 is seated, providing support for the spring member 529. When the axial limiter 522 provides axial restraint in the first position 524a or the second position 524b, the push member 528 is in a popped-up state, and the spring member 529 causes the annular plate 525a to engage with the first engaging portion 571a or the second engaging portion 571b, thereby limiting the axial movement of the cylindrical body 524. When the axial limiter 522 is released from the axial restraint in the first position 524a or the second position 524b (the axial limiter is released from the coupling with the actuating shaft in the first position or the second position), the push member 528 is in a pressed-down state, and the annular plate 525a moves toward the spring member 529, compressing the spring member 529. The annular plate 525a is released from the first engaging portion 571a or the second engaging portion 571b, thereby releasing the axial movement restriction on the cylindrical body 524; at this point, the cylindrical body 524 can directly move axially. For example, when the annular plate 525a is disengaged from the first engagement portion 571a, the cylindrical body 524 is pulled proximally. Under the elastic force of the spring member 529, the inner wall of the annular plate 525a can contact the outer wall of the cylindrical body 524. When the cylindrical body 524 moves until its second engagement portion 571b is aligned with the annular plate 525a, the annular plate 525a engages with the second engagement portion 571b under the elastic force of the elastic member 529, thereby automatically limiting the axial position of the actuating shaft 220. More specifically, the first position 524a is located proximal to the second position 524b, and the distance between the first position 524a and the second position 524b defines the distance between the first proximal position and the second proximal position of the actuating shaft 220.

[0102] Preferably, the first engaging portion 571a is configured as a groove having a non-circular cross-section. When the annular plate 525a is engaged with the first engaging portion 571a, the cylindrical body 524 cannot rotate, thereby preventing the actuating shaft 220 from rotating. When the annular plate 525a is disengaged from the first engaging portion 571a, the cylindrical body 524 can rotate in a selectable direction.

[0103] When the control knob 521 is operated to position the actuating shaft 220 at the first proximal position, i.e., when the travel indicator mark 523c is aligned with the minimum scale, the axial limiter 522 can be operated to release the engagement between the annular plate 525a and the first engagement portion 571a, thereby decoupling the control knob 521 from the cylindrical body 524 (actuating shaft 220). Subsequently, rotating the handle 584 in a first direction (e.g., counterclockwise) can disconnect the actuating shaft 220 from the implant 100. By providing a one-way rotation control mechanism to limit the rotation direction of the cylindrical body 524, it is possible to prevent the actuating shaft 220 from rotating in a second direction (e.g., clockwise) when connected to the implant 100, thereby entering a thread dead zone and becoming unable to separate.

[0104] refer to Figure 5A 、 Figure 10A 、 12A to 12C The one-way rotation control mechanism is specifically configured as a one-way clutch 526. The one-way clutch 526 is arranged at a position on the large diameter section 523b that is different from the axial limiter 522. More specifically, the one-way clutch 526 and the axial limiter 522 are axially staggered, and their operating ends are radially opposed. For example, the axial limiter 522 is arranged proximally and at the upper portion of the large diameter section 523b, while the one-way clutch 526 is arranged distally and at the lower portion of the large diameter section 523b. The one-way clutch 526 extends radially as a whole and is axially fixed relative to the push screw 523. The inner end of the one-way clutch 526 is configured to include asymmetric teeth, which releasably abut the side wall of the cylindrical body 524. The section of the cylindrical body 524 that contacts the one-way clutch 526 is splined, and the spline teeth of this contacting section are configured as one-way ratchets that can engage with the inner end of the one-way clutch 526. More specifically, the length of the spline of the cylindrical body 524 with the one-way ratchets must be sufficient to allow the distal end of the actuating shaft 220 to be unthreaded from the threaded section at the distal end of the implant 100 (valve clamp). When the inner end of the one-way clutch 526 is engaged with the cylindrical body 524, the cylindrical body 524 can be rotated in a first direction (e.g., counterclockwise) to decouple the actuating shaft 220 from the implant 100, while inhibiting rotation of the cylindrical body 524 in a second direction (e.g., clockwise). When the inner end of the one-way clutch 526 is disengaged from the cylindrical body 524, the cylindrical body 524 can be rotated in the second direction to reconnect the actuating shaft 220 to the implant.

[0105] Continue to refer Figure 12A and Figure 12B Specifically, the 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. The clutch spring 576 is sleeved onto the clutch shaft 527, with one end of the clutch spring 576 abutting the inner wall of the large-diameter section 523b, and the other end of the clutch spring 576 abutting the inner end of the clutch shaft 527. The clutch sleeve 546 and the clutch shaft 527 are relatively fixed in the axial direction of the clutch shaft 527. The clutch sleeve 546 is rotatably connected to the outer end of the clutch shaft 527 about the axis of the clutch shaft 527. The clutch knob 549 is fixedly connected to the clutch sleeve 546 from the outside, and the outer periphery of the clutch knob 549 is provided with anti-slip features. The clutch knob 549 is configured as an operating end of the one-way clutch 526 . Operating the clutch knob 549 can cause the clutch sleeve 546 to move radially and rotate relative to the large diameter portion 523 b of the push screw 523 .

[0106] Further, refer to Figure 12C The clutch sleeve 546 has a protrusion 547, such as a rib, on its outer circumference. A notch 548, which engages with the protrusion 547, is provided on the circumference of the large-diameter portion 523b of the push screw 523. When the clutch sleeve 546 rotates and moves inward until the protrusion 547 seats in the notch 548 outside the large-diameter portion 523b, the sidewalls of the notch 548 restrict the rotation of the clutch sleeve 546. The inner end of the clutch shaft 527, under the action of the clutch spring 576, engages with the cylindrical body 524, restricting the cylindrical body 524 to unidirectional rotation, thereby restricting the rotation of the actuating shaft 220. When the clutch sleeve 546 moves outward to disengage the protrusion 547 from the slot 548 on the outside of the large diameter portion 523b, the clutch spring 576 is compressed, the inner end of the clutch shaft 527 disengages from the cylindrical body 524, and the clutch sleeve 546 can be rotated to a position where the clutch sleeve 546 abuts against the non-slot portion on the outer periphery of the large diameter portion 523b of the push screw.

[0107] The working methods of the axial limiter 522 and the one-way clutch 526 are described below.

[0108] When the actuating shaft 220 is threadedly connected to the implant 100, the axial stopper 522 provides axial restraint in the first position 524a. The protrusion 547 on the clutch sleeve 546 is aligned with the notch 548 on the large diameter portion 523b of the push screw 523. The protrusion 547 is seated in the notch 548. The sidewall of the notch 548 restricts the rotation of the clutch sleeve 546. The inner end of the clutch shaft 527 is engaged with the cylindrical body 524, and the rotary handle 584 can only rotate in the first direction (counterclockwise).

[0109] Operating the control knob 521 advances or retracts the actuating shaft 220, thereby opening (opening the clip 150) or closing (closing the clip 150) the implant 100. After capturing the leaflets, when the actuating shaft 220 moves proximally to the first proximal position, the implant 100 is in a closed state. The control knob 521 rotates relative to the push screw 523, causing the actuating shaft 220 to reach its proximal travel limit, and the control knob 521 cannot further move the actuating shaft 220 proximally.

[0110] Furthermore, pressing the push member 528 releases the axial limiter 522 from being limited in the first position 524 a . Rotating the knob 584 in a first direction (counterclockwise) releases the threaded connection between the actuating shaft 220 and the implant 100 .

[0111] Furthermore, the handle 584 is pulled proximally to drive the axial movement of the actuating shaft 220. When the cylindrical body 524 moves proximally to the second position 524b and aligns with the axial stopper 522, the actuating shaft 220 moves to the second proximal position, and the spring member 529 resets, causing the annular plate 545 to automatically move upward to the annular groove corresponding to the second position 524b, thereby allowing the axial stopper 522 to resume axial restriction of the cylindrical body 524.

[0112] Furthermore, the clutch knob 549 is pulled outward (downward) and rotated, causing the protrusion 547 on the clutch sleeve 546 to leave the notch 548 and rotate away from the notch 548, thereby releasing the engagement between the inner end of the clutch shaft 527 and the cylindrical body 524. Then, rotating the knob 584 in a second direction (clockwise) connects the actuating shaft 220 to the implant a second time.

[0113] The above are only several embodiments of the present disclosure. Those skilled in the art may make various changes or modifications to the embodiments of the present disclosure based on the contents disclosed in the application documents without departing from the spirit and scope of the present disclosure.

Claims

1. A sheath assembly for manipulating an implant, the sheath assembly comprising: handle housing; a multi-lumen tube extending distally from the handle housing; an actuation shaft extending through the multi-lumen tubing, the actuation shaft being configured to couple to the implant; as well as An actuating shaft control mechanism, the actuating shaft control mechanism comprising: a control knob coupled to the actuation shaft, the control knob being rotatable relative to the handle housing, wherein rotation of the control knob causes the actuation shaft to move axially relative to the handle housing and the multi-lumen tubing; and a releasable axial stopper, the axial stopper being selectively coupled to a first position or a second position proximal to the actuation shaft; Wherein, when the axial limiter is coupled to the first position, the actuating shaft can move axially between the distal position and the first proximal position under the rotation of the control knob; when the actuating shaft is at the first proximal position and the axial limit of the axial limiter at the first position is released, the actuating shaft can be freed from the rotation of the control knob and continue to move axially toward the proximal end until the axial limiter is coupled to the second position; when the axial limiter is coupled to the second position, the axial limiter provides axial limit to the actuating shaft at the second position, and the actuating shaft is at the second proximal position; Among them, the first position is located proximal to the second position; when the actuating shaft is located at the distal position, the opening angle of the implant is the largest; when the actuating shaft is at the first proximal position, the opening angle of the implant is the smallest; when the actuating shaft is at the second proximal position, the actuating shaft and the implant are in a disconnected state, and the distal end of the actuating shaft is restored to a state where it can be reconnected to the implant.

2. The sheath assembly according to claim 1, wherein The actuating shaft control mechanism also includes a push screw, which is axially movably connected to the handle housing and is axially fixed relative to the axial limiter. The push screw is threadably coupled to the control knob, so that rotation of the control knob advances or retracts the push screw in the axial direction, thereby causing axial movement of the actuating shaft.

3. The sheath assembly according to claim 2, wherein: The actuating shaft control mechanism further includes an axially extending cylindrical body, the proximal end of the actuating shaft is fixedly connected to the cylindrical body, the distal end of the cylindrical body extends axially into the pushing screw, and the cylindrical body provides the first position and the second position; When the axial limiter is coupled to the first position or the second position, the cylindrical body and the push screw are relatively fixed in the axial direction; when the axial limiter is uncoupled from the first position or the second position, the cylindrical body can move axially relative to the push screw.

4. The sheath assembly according to claim 3, wherein: The axial limiter is arranged at the proximal end of the pushing screw, and the proximal end of the pushing screw is provided with a receiving groove; The axial limiter is constructed to include a push member, a stop member, and a spring member. The stop member includes an annular plate and a first end and a second end extending from the annular plate toward two radially opposite sides. The first end of the stop member is connected to the push member, the second end of the stop member is connected to one end of the spring member, and the other end of the spring member is located in and abuts against the accommodating groove. The cylindrical body extends through the middle hole of the annular plate. The cylindrical body is provided with a first engagement groove corresponding to the first position and a second engagement groove corresponding to the second position. When the spring member causes the annular plate to engage with the first engagement groove or the second engagement groove, the push member is in a spring-up state, and the axial limiter is coupled to the first position or the second position. When the push member is in the pressed state, the spring member is compressed, the annular plate is released from the first engagement groove or the second engagement groove, and the axial limiter is released from the first position or the second position.

5. The sheath assembly according to claim 4, characterized in that The cross section of the first engaging groove is configured as a non-circular structure.

6. The sheath assembly according to claim 5, characterized in that The actuating shaft control mechanism further includes a one-way clutch radially extending into the push screw, the one-way clutch and the push screw being relatively fixed in the axial direction, the inner end of the one-way clutch being configured to include asymmetric teeth, and the inner end of the one-way clutch being releasably abutted against the cylindrical body; A section of the cylindrical body that contacts the one-way clutch is configured as a spline, and the spline teeth of the contacting section are configured as one-way ratchets that can mesh with the inner end of the one-way clutch. When the inner end of the one-way clutch is engaged with the cylindrical body, the cylindrical body can rotate in a first direction to disengage the actuating shaft from the implant and inhibit the cylindrical body from rotating in a second direction; when the inner end of the one-way clutch is disengaged from the cylindrical body, the cylindrical body can rotate in a second direction to reconnect the actuating shaft to the implant; wherein the first direction is opposite to the second direction.

7. The sheath assembly according to claim 6, wherein: The one-way clutch includes a clutch sleeve, a clutch shaft, and a clutch spring. The inner end of the clutch shaft is configured to include the asymmetric teeth. The clutch spring is sleeved on the clutch shaft. One end of the clutch spring abuts against the inner wall of the push screw, and the other end of the clutch spring abuts against the inner end of the clutch shaft. The clutch sleeve and the clutch shaft are relatively fixed in the axial direction of the clutch shaft, and the clutch sleeve is rotatably connected to the outer end of the clutch shaft around the axis of the clutch shaft. The outer periphery of the clutch sleeve is provided with a protrusion, and the outer periphery of the push screw is provided with a notch capable of receiving the protrusion; When the clutch sleeve rotates and moves inwardly so that the protrusion sits in the notch of the push screw, the inner end of the clutch shaft engages with the cylindrical body under the action of the clutch spring, and the side wall of the notch limits the rotation of the clutch sleeve; when the clutch sleeve moves outward so that the protrusion disengages from the notch of the push screw, the clutch spring is compressed, the inner end of the clutch shaft disengages from the cylindrical body, and the clutch sleeve is rotated so that the clutch sleeve abuts against the non-notch portion of the outer periphery of the push screw.

8. The sheath assembly according to claim 7, wherein: The one-way clutch further comprises a clutch knob which is fixedly connected to the clutch sleeve from the outside, and an anti-slip feature is provided on the outer periphery of the clutch knob.

9. The sheath assembly according to claim 6, wherein: The pushing screw is configured to include a small diameter section and a large diameter section arranged in the axial direction; The small diameter section provides a rotational coupling path for the control knob, and rotation of the control knob causes the push screw to move axially, thereby causing the actuating shaft to move axially relative to the handle housing and the multi-lumen tube; The large diameter section provides an installation position for the axial limiter and the one-way clutch. The proximal end of the cylindrical body extends beyond the proximal end of the large diameter section, and the proximal end of the cylindrical body forms a radially enlarged rotary handle.

10. The sheath assembly according to claim 9, wherein: The small diameter section is provided with a travel indicator mark along the axial direction, and the travel indicator mark is used to indicate the opening angle of the implant.

11. The sheath assembly according to claim 3, wherein: The cylindrical body is provided with an axially extending hollow cavity, the actuating shaft extends through the hollow cavity and the proximal end of the actuating shaft is fixed to the proximal end of the hollow cavity; A reinforcement tube is provided on the outer sleeve of the actuating shaft. The reinforcement tube is fixedly connected to the actuating shaft and extends from the proximal end of the hollow cavity to the proximal end of the multi-cavity tube.

12. A delivery system for delivering an implant, characterized in that: The delivery system comprises: a first sheath assembly having a handle and a sheath extending in an axial direction from the handle, the sheath of the first sheath assembly having a distal end portion including a steerable section; and a second sheath assembly, wherein the second sheath assembly is the sheath assembly according to any one of claims 1 to 11, and the multi-lumen tube of the second sheath assembly coaxially extends through the sheath of the first sheath assembly; In which, a relative fixing mechanism is provided between the handle of the second sheath assembly and the handle of the first sheath assembly, and the relative fixing mechanism extends distally from the handle shell of the second sheath assembly, and the relative fixing mechanism is configured to keep the distance between the handle of the first sheath assembly and the handle of the second sheath assembly fixed.

13. The conveying system according to claim 12, characterized in that The distance between the handle of the first sheath assembly and the handle of the second sheath assembly is adjustable.

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