CN114681145A

CN114681145A - Implant and adjustable wire locking device

Info

Publication number: CN114681145A
Application number: CN202011624728.3A
Authority: CN
Inventors: 张庭超; 匡经旭; 郭荣辉
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2022-07-01

Abstract

The application relates to an implant and an adjustable wire locking device. The implant includes a housing assembly, a wire wrap, and a stop. The proximal end of the housing assembly is provided with an opening; the winding piece is arranged in the shell assembly, and the near end of the winding piece is movably arranged in the opening in a penetrating way; the stop piece is connected with the shell assembly, and a first limiting piece is arranged at the proximal end of the stop piece; the far end of the winding piece and the near end of the stopping piece are far away or close to each other, so that the first limiting piece and the winding piece are separated from each other or the first limiting piece and the far end of the winding piece are in plug fit. The adjustable wire locking device comprises the implant. The implant and the adjustable wire locking device can adjust the wire winding degree in real time, so that the locked degree of the suture is proper.

Description

Implant and adjustable wire locking device

Technical Field

The application belongs to the technical field of medical equipment, and particularly relates to an implant and an adjustable wire locking device.

Background

The expansion of the valve annulus, one of the most common causes of valvular heart disease, can cause the leaflets to separate from each other during ventricular systole, creating gaps that no longer effectively close or coapt, causing regurgitation of blood and reduced cardiac output.

Annuloplasty on annular dilation is an important procedure for mitral or tricuspid valve repair, and its principle is to reduce or eliminate regurgitation by contracting the annulus to reduce the area of the mitral or tricuspid valve orifice to allow the leaflets to conform to each other during ventricular contraction, in response to leaflet insufficiency caused by annular dilation. Although surgically applied annuloplasty can repair the annulus well, it has the disadvantages of great trauma, high risk, slow recovery of the patient, etc. In recent years, transcatheter minimally invasive interventional annuloplasty has been developed, which uses a corresponding annuloplasty device to annulate the mitral or tricuspid valve without beating the heart. During the surgical procedure of transcatheter minimally invasive interventional annuloplasty, it is generally necessary to repair and reduce the annulus by anchoring an anchor with sutures on the heart valve annulus in the circumferential direction of the annulus and then tightening the sutures using a wire locking device. However, in the existing wire locking device, the suture can be extruded or wound in one direction only all the time in the wire locking process, so that continuous locking is realized. When the operator realizes that the suture is locked too tightly, the suture cannot be loosened in the suture locking device, so that the tightness of the suture cannot be adjusted in real time, the operation effect is influenced, and even the operation fails.

Disclosure of Invention

The utility model provides an implant and adjustable locking wire device to solve among the prior art behind the suture of locking wire device is locked, can't adjust the technical problem of the elasticity of suture in real time.

To achieve the above object, a first aspect of the present invention provides an implant comprising:

a housing assembly having an opening at a proximal end;

the winding piece is arranged in the shell assembly, and the near end of the winding piece is movably arranged in the opening in a penetrating way;

the stop piece is connected with the shell assembly, and a first limiting piece is arranged at the proximal end of the stop piece;

the distal end of the wire winding piece and the proximal end of the stopper are far away from or close to each other, so that the first limiting piece and the wire winding piece are separated from each other or the first limiting piece and the distal end of the wire winding piece are in plug fit.

To achieve the above object, a second aspect of the present invention provides an adjustable wire locking device, including: the implant comprises a handle, an operating component and the implant, wherein the far end of the operating component is detachably connected with the near end of the implant, and the near end of the operating component is connected with the handle.

Compared with the prior art, the invention at least has the following beneficial effects:

according to the implant and the adjustable wire locking device, the tightness of the suture is adjusted in real time by controlling the whole wire locking device. In the suture locking process, if the current winding degree is observed to be too large, the length of the released suture is too short, and when the suture locking device is adjusted, the far end of the winding piece is separated from the near end of the stop piece, then the winding piece is rotated, and the current winding degree is adjusted to be small. Similarly, if the current thread-winding pass is observed to be too small, which indicates that the released suture length is too long, the adjustment direction is opposite to the above. When the current winding degree is observed to be the required winding degree in real time and the locked degree of the suture is proper, the first limiting part on the control stopping piece is in inserting fit with the far end of the winding piece, and therefore the adjusted winding degree is locked. This process can be repeated multiple times if the degree of suture winding still needs to be adjusted again. Therefore, the thread winding degree can be adjusted in real time by adopting the design of the application, so that the locked degree of the suture is proper, and the operation effect is ensured.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art to obtain other drawings without any inventive exercise.

Fig. 1 is an overall view of an adjustable wire locking device according to an embodiment.

FIG. 2 is a cross-sectional view of an operating assembly shown in accordance with an embodiment.

Fig. 3 is a schematic structural diagram of a rotating shaft according to an embodiment.

Fig. 4 is a sectional view of the wire winding member shown in the first embodiment in a state where the wire winding member is separated from the stopper.

FIG. 5 is an enlarged view of a portion of the portion A of FIG. 4;

fig. 6 is a sectional view showing a state where the wire winding member is coupled to the stopper according to the first embodiment.

Fig. 7 is a partially enlarged view of a portion B in fig. 6.

Fig. 8 is a schematic structural diagram of a winding element according to an embodiment.

Fig. 9 is a schematic structural diagram of a housing assembly according to an embodiment.

FIG. 10 is a schematic structural diagram of a stopper according to an embodiment.

FIG. 11 is a schematic view of a stopper engaged with a housing according to an embodiment.

Fig. 12 is a schematic structural view of a rotating shaft according to the second embodiment.

Fig. 13 is a schematic structural view of the elastic member according to the second embodiment.

Fig. 14 is a schematic structural view of the elastic member and the housing according to the second embodiment.

Fig. 15 is a schematic structural view of the wire winding member according to the second embodiment.

Fig. 16 is a top view of fig. 15.

Fig. 17 is a schematic structural view of the housing according to the second embodiment.

Fig. 18 is a partial enlarged view of the position C in fig. 17.

Fig. 19 is a structural schematic diagram of the second embodiment of the assembled housing and winding member.

Fig. 20 is a partial enlarged view of the position D in fig. 19.

Fig. 21 is a schematic view illustrating deformation of the second limiting member when the winding member rotates relative to the housing according to the second embodiment.

Fig. 22 is a partial enlarged view of the position E in fig. 21.

Fig. 23 is an exploded view of the implant shown in example two.

Fig. 24 is a sectional view showing the state where the wire winding member is separated from the stopper according to the second embodiment.

Fig. 25 is a partial enlarged view of the position F in fig. 24.

Fig. 26 is a sectional view showing a state where the wire winding member is connected to the stopper according to the second embodiment.

Fig. 27 is a partial enlarged view of the position G in fig. 26.

Fig. 28 is a schematic view of an adjustable wire locking device used for mitral annuloplasty.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It should be understood that the directions and positional relationships indicated by the terms "front", "back", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", etc. are constructed and operated in specific directions based on the directions and positional relationships shown in the drawings, and are only for convenience of describing the technical solution, but do not indicate that the device or element referred to must have a specific direction, and thus, cannot be construed as limiting the present invention.

It is also noted that, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally formed; they may be directly connected or indirectly connected through intervening media, or may be connected through the interconnection of two elements or through the interaction of two elements. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the description of the present invention, it is still to be noted that the proximal end refers to the end of the instrument or component close to the operator, and the distal end refers to the end of the instrument or component away from the operator; axial refers to a direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential refers to a direction around the axial direction.

Example one

As shown in fig. 1, the present invention exemplarily provides an adjustable wire locking device, including: a handle assembly 1000, a handle 2000 and an implant 3000, wherein the distal end of the handle assembly 1000 is detachably connected to the proximal end of the implant 3000, and the proximal end of the handle assembly 1000 is connected to the handle 2000.

Specifically, as shown in fig. 2, in order to ensure a stable connection between the operating assembly 1000 and the implant 3000, the operating assembly 1000 includes: the connecting member 1100, the connecting member 1100 and the implant 3000 are detachably connected, and the connecting member 1100 has a hollow structure and a diameter gradually increasing from a proximal end to a distal end. Further, in order to ensure that the instrument does not poison human tissues after entering the human body, the connection member 1100 is made of a biocompatible polymer material or a metal material. Preferably, medical stainless steel is used.

Specifically, in order to further realize the detachable connection between the operation assembly 1000 and the implant 3000, the far end of the connection member 1100 is convexly provided with a claw 1110, the housing assembly 3100 of the implant 3000 is provided with a clamping groove matched with the claw 1110, and the far end of the connection member 1100 is stably detachably connected with the implant 3000 through the matching of the claw 1110 and the clamping groove.

Specifically, the operating assembly 1000 further comprises: sheath 1200, the distal end of sheath 1200 is fixedly connected with connector 1100. Preferably, the sheath 1200 is a hollow multilayer composite tube, the inner layer of the sheath is a PTFE inner membrane layer, the middle layer is a metal woven reinforcing mesh, and the outer layer is covered with a Pebax material, so that torque can be transmitted remotely.

Further, the operation assembly 1000 further comprises: the proximal end of the threaded shaft 1300 is movably inserted into the sheath 1200, and the distal end of the threaded shaft 1300 is detachably connected to the wire winding portion 3210 of the implant 3000. Preferably, the threaded shaft 1300 is a flexible segment with a certain length, and can bend and transmit torque, the distal end of the threaded shaft 1300 is provided with a thread capable of matching with the implant 3000, so as to realize the threaded connection between the threaded shaft 1300 and the implant 3000, and the threaded shaft 1300 can shuttle in the lumen formed after the sheath 1200 and the connecting piece 1100 are assembled. Alternatively, the proximal end of the connector 1100 and the inner wall of the distal end of the sheath 1200 may be concentrically fitted and fastened by gluing, welding, clipping, screwing, or the like.

Specifically, as shown in fig. 2 and 3, the operating assembly 1000 further includes: the rotating shaft 1400, the rotating shaft 1400 movably penetrates the threaded shaft 1300, and the distal end is detachably connected with the implant 3000. Further, a first fixing element 1410 is disposed at a distal end of the rotating shaft 1400 extending out of the threaded shaft 1300, and a second fixing element 3223 matching with the first fixing element 1410 is disposed in the implant 3000. Preferably, the first fixing element 1410 and the second fixing element 3223 are configured as a protrusion and a mounting hole which are matched with each other. In this embodiment, as shown in fig. 2-7, the first fixing element 1410 is configured as a rectangular segment, and the second fixing element 3223 is configured as a rectangular hole. Alternatively, the shaft 1400 may be provided as a solid rod or hollow tube with a flexible section having a length at the distal end to allow bending and torque transmission.

It can be understood that, when the operating assembly 100 cooperates with the implant 3000, first, the sheath 1200 is stably connected with the housing 3130 of the implant 3000 through the cooperation of the claws 1110 and the slots, then the detachable connection of the rotating shaft 1400 with the winding element 3200 of the implant 3000 is realized by the cooperation of the first fixing element 1410 and the second fixing element 3223, and then, the threaded connection between the threaded shaft 1300 and the winding element 3200 of the implant 3000 is realized through the threads engaged with each other, so that the rotation of the winding element 3200 of the implant 3000 is controlled by driving the rotating shaft 1400 to rotate, and the suture thread passing through the winding element 3200 is locked or loosened.

In this embodiment, as shown in fig. 1, the handle 2000 includes a housing, and a first operation switch 2100, a second operation switch 2200, a third operation switch 2300 and a fourth operation switch 2400 disposed on the housing, wherein the first operation switch 2100 is used for controlling a relative position between the threaded shaft 1300 and the sheath 1200, the second operation switch 2200 is used for controlling a relative position between the rotating shaft 1400 and the sheath 1200, the third operation switch 2300 is used for driving the threaded shaft 1300 to rotate, and the fourth operation switch 2400 is used for controlling the rotating shaft 1400 to rotate, so as to control a locking process and a releasing process of the implant 3000. Specifically, the structures of the first operating switch 2100, the second operating switch 2200, the third operating switch 2300 and the fourth operating switch 2400, the control structure of the first operating switch 2100 and the third operating switch 2300 on the driving threaded shaft 1300, and the control structure of the second operating switch 2200 and the fourth operating switch 2400 on the rotating shaft 1400 are all the prior art, and therefore, redundant description is not repeated herein.

Specifically, as shown in fig. 4-11, the present invention discloses an implant 3000 comprising: a housing assembly 3100 having an opening 3111 at a proximal end; a winding member 3200 mounted in the housing assembly 3100, the proximal end of the winding member 3200 movably inserted into the opening 3111; the stopping member 3300 is connected to the housing assembly 3100, and a first stopper 3310 is disposed at a proximal end of the stopping member 3300, and the first stopper 3310 is adapted to be inserted into the distal end of the winding member 3200. The proximal end of the winding member 3200 extends from the opening 3111 to separate the distal end of the winding member 3200 from the proximal end of the stopper 3300, and the proximal end of the winding member 3200 retracts into the opening 3111 to connect the first stopper 3310 of the winding member 3200 to the proximal end of the stopper 3300.

Specifically, the housing assembly 3100 includes: a first housing 3110, a housing 3130, and a second housing 3120, the housing 3130 having a hollow cylindrical structure, the first housing 3110 being mounted to a proximal end of the housing 3130, the second housing 3120 being mounted to a distal end of the housing 3130, the winding member 3200 and the stopper 3300 being mounted in the housing 3130, and the opening 3111 being opened in the first housing 3110.

Further, in order to ensure that the instrument does not poison human tissues after entering the human body, the first housing 3110, the outer housing 3130 and the second housing 3120 are made of biocompatible polymer materials or metal materials, preferably, medical stainless steel.

Specifically, the winding member 3200 includes: the thread winding device comprises a thread winding portion 3210 and a base 3220 connected to a distal end of the thread winding portion 3210, wherein a thread passing hole 3211 for passing a thread is formed in the thread winding portion 3210. Preferably, the wire holes 3211 penetrate the wire winding portion 3210, and preferably, the wire holes 3211 are perpendicular to the axial direction of the wire winding portion 3210 in at least one pair. In the threading, one end of the thread firstly passes through the thread passing hole 3211, and then the thread winding member 3200 is controlled by the rotation shaft 1400, so that the thread is wound on the outer wall surface of the thread winding part 3210, thereby reducing the length of the thread and locking the thread.

Optionally, the housing 3130 is provided with a threading hole 3135 matching with the threading hole 3211. Preferably, the threading holes 3135 are provided in two pairs of 4 threading holes arranged in parallel. Further, threading holes 3135 are opened at opposite sides of the outer circumferential surface of the housing 3130. During threading, one end of the thread firstly enters the inner cavity of the housing 3130 through the threading hole 3135, and then passes through the thread passing hole 3211 arranged on the thread winding portion 3210, the winding member 3200 is controlled by rotating the rotating shaft 1400, and the thread is wound on the outer wall surface of the thread winding portion 3210. After the winding is completed, if the current winding degree is observed to be too large, the length of the released suture is too short, and only the rotating shaft 1400 needs to be controlled to rotate the winding element 3200, so that the current winding degree is reduced, and the length of the released suture is adjusted and increased. Similarly, if the current winding degree is observed to be too small, the length of the released suture is too long, and the adjustment process is opposite to the above.

Further, in order to ensure that the winding member 3200 is stably mounted in the housing assembly 3100, a flange 3132 is further provided on an inner wall surface of the outer case 3130, and an outer wall surface of the base 3220 is in contact with the flange 3132. Further, in order to ensure that the instruments do not poison human tissues after entering the human body, the winding member 3200 is made of a biocompatible polymer material or a metal material, preferably, medical stainless steel.

Specifically, the body portion of stop 3300 is preferably provided as a piece of sheet metal in intimate contact with the distal end face of wire winding member 3200. At least two first lugs 3320 are protruded from the edge of the stop 3300, and a first groove 3131 for accommodating the first lugs 3320 is opened on the housing 3130. The stopper 3300 is stably coupled to the housing 3130 and prevents the stopper 3300 from rotating with respect to the housing 3130 by the engagement of the first lug 3320 with the first groove 3131.

Further, to ensure that the device will not poison human tissue after entering the body, the stop 3300 is made of a biocompatible polymer material or a metal material, preferably, medical stainless steel.

Specifically, the first position-limiting members 3310 are disposed at the proximal end of the stopping member 3300, the distal end of the winding member 3200 is correspondingly disposed with the first position-limiting members 3310, the first position-limiting members 3310 are in one-to-one correspondence with the first position-limiting grooves 3221, and the first position-limiting members 3310 and the first position-limiting grooves 3221 are adapted to form a position-limiting structure. Preferably, the number of the first position-limiting members 3310 is two, the two first position-limiting members 3310 are respectively disposed at two ends of the stop member 3300, the number of the first position-limiting grooves 3221 is multiple, and the multiple first position-limiting grooves 3221 are distributed on the base 3220 at intervals, so as to ensure that the wire winding member 3200 can be stably connected to the stop member 3300 through the insertion and connection between the first position-limiting grooves 3221 and the first position-limiting members 3310, thereby locking the current wire winding degree.

Further, the depth of the first groove 3131 disposed on the housing 3130 is greater than the thickness of the first lug 3320 disposed at the edge of the stopper 3300, which ensures that the stopper 3300 can only move along the axis relative to the housing 3130 and cannot rotate relative to the housing 3130, thereby ensuring the stable plugging and matching between the first position-limiting member 3310 disposed on the stopper 3300 and the first position-limiting groove 3221 disposed on the winding member 3200.

It can be understood that, after the locking of the current winding degree is realized, if the current winding degree is observed to be too large, which indicates that the length of the released suture is too short, the winding member 3200 moves toward the opening 3111 extending out of the housing assembly 3100, so as to drive the distal end of the winding member 3200 to separate from the proximal end of the stopper 3300, that is, the first position-limiting member 3310 is pulled out from the first position-limiting groove 3221, and then the winding member 3200 is rotated by controlling the rotating shaft 1400, so as to reduce the current winding degree. Then, the winding member 3200 is pushed to move in the direction of the retraction opening 3111 to drive the distal end of the winding member 3200 to be inserted into the proximal end of the stopper 3300, that is, the first position-limiting member 3310 is inserted into the first position-limiting groove 3221 again, so that the winding degree after real-time adjustment can be locked. Similarly, if the current winding degree is observed to be too small, which indicates that the length of the released suture is too long, the adjustment process is opposite to the above. Therefore, the scheme of the example can realize real-time adjustment of the winding degree after the suture is locked, thereby ensuring the operation effect.

The specific working process is as follows:

as shown in fig. 4 and 5, in the initial state, the winding member 3200 is separated from the stopper 3300. Therefore, when the sheath 1200 and the housing 3130 are assembled by the engagement between the jaws 1110 and the slots, the threaded shaft 1300 is first rotated to screw-couple the threaded shaft 1300 and the winding portion 3210. For convenience of understanding, the clockwise rotation of the threaded shaft 1300 relative to the wire reel 3200 is exemplarily defined as an unscrewed state; conversely, the threaded shaft 1300 is defined as being screwed up counterclockwise relative to the winding element 3200, it is understood that the threaded shaft 1300 can be also screwed up clockwise relative to the winding element 3200, the threaded shaft 1300 is defined as being unscrewed counterclockwise relative to the winding element 3200, and the direction is not to be construed as limiting the present embodiment. Then, the driving rotation shaft 1400 is extended from the distal end of the threaded shaft 1300 until the first fixing element 1410 disposed on the rotation shaft 1400 is inserted into the second fixing element 3223 disposed on the winding element 3200, so as to achieve stable connection between the rotation shaft 1400 and the winding element 3200. Then, one end of the thread enters the inner cavity of the outer shell 3130 through the thread passing hole 3135 and passes through the thread passing hole 3211 arranged on the thread winding portion 3210 and the thread passing hole 3135 on the opposite side of the outer shell 3130. At this time, the rotating shaft 1400 is rotated to drive the winding member 3200 to rotate synchronously, so that the thread is wound on the outer wall surface of the winding portion 3210, and at this time, the current winding degree can be locked. If the current thread winding degree is too large, it is indicated that the length of the released suture is too short, and the first limiting member 3310 is separated from the first limiting groove 3221 only by retracting the threaded shaft 1300, and then the winding member 3200 is rotated reversely by the rotating shaft 1400, so that the current thread winding degree is reduced. Similarly, if the current winding degree is observed to be too small, the length of the released suture is too long, and the adjusting direction is opposite to the adjusting direction. The above operations are repeated until the current winding degree is observed in real time as the required winding degree, and the rotation of the rotating shaft 1400 is stopped. At this time, the wire winding member 3200 is pushed by the screw shaft 1300 to move the wire winding member 3200 in the direction of the retraction opening 3111, so that the first position-limiting member 3310 is inserted into the first position-limiting groove 3221 again, thereby locking the current winding degree. After the real-time adjustment of the tightness of the suture is completed, the rotating shaft 1400 is pulled proximally until the first fixing element 1410 is separated from the second fixing element 3223; then, the threaded shaft 1300 is driven to release the threaded shaft 1300 and the winding element 3200; finally, the sheath 1200 is withdrawn proximally, which causes the claws 1110 to separate from the slots, thereby releasing the sheath from the housing assembly 3100, and leaving the implant 3000 in the patient.

Example two

As shown in fig. 12 and fig. 25 to 28, compared with the adjustable wire locking device of the first embodiment, the adjustable wire locking device of the present embodiment has the following differences:

the distal end of the first fixing element 1410 is further protruded with a limiting portion 1420. The stopper 1420 is formed as a cylindrical section having a diameter smaller than the width of the rectangular hole. Specifically, during operation, the rotating shaft 1400 is connected to the winding element 3200 through the engagement of the first fixing element 1410 and the second fixing element 3223, and then is in contact with the stop 3300 through the limiting portion 1420 of the rotating shaft 1400, so that the stop 3300 is controlled to move toward the second housing 3120 under the action of the rotating shaft 1400.

As shown in fig. 14-28, this embodiment provides an implant 3000 that differs from the implant 3000 of the first embodiment by:

specifically, the proximal end of the wire winding portion 3210 is spaced apart and sleeved with a first annular plate 3230 and a second annular plate 3240, a distal end of the first annular plate 3230 abuts against a proximal end of the first housing 3110, and a proximal end of the second annular plate 3240 abuts against a distal end of the first housing 3110. With the design of this embodiment, the proximal end of wire winding member 3200 can be confined within opening 3111 of first housing 3110 such that during transport or handling, when the entire implant 3000 is flipped upside down, wire winding member 3200 does not move axially relative to housing 3130, but rather freely rotates in a spatial trajectory between first annular plate 3230 and second annular plate 3240. Preferably, the first and second

annular plates

3230 and 3240 are concentrically and fixedly coupled to the proximal end of the wire winding portion 3210 by laser welding, respectively. Further, in order to ensure that the device will not poison human tissues after entering the human body, the first annular plate 3230 and the second annular plate 3240 are made of biocompatible polymer material or metal material, preferably, medical stainless steel.

Specifically, the implant 3000 further includes: a resilient member 3400, the resilient member 3400 being mounted within the housing assembly 3100 with a proximal end abutting a distal end of the stop 3300. Furthermore, at least two second support lugs 3410 are protruded from the edge of the elastic element 3400, and a second groove 3134 for accommodating the second support lugs 3410 is opened on the housing 3130. Preferably, the elastic member 3400 is integrally a thin nitinol sheet, and the elastic member 3400 and the housing 3130 are stably connected by the second support 3410 cooperating with the second groove 3134. After the heat treatment, the elastic element 3400 is in a natural state (i.e., an unstressed state) as shown in fig. 13, specifically, the elastic element 3400 includes an annular main body and a plurality of elastic sheets arranged on the annular main body at intervals along the circumferential direction, each elastic sheet extends from the annular main body to the proximal end and simultaneously to a direction close to the central axis of the annular main body, and a gap is formed between two adjacent elastic sheets; when the elastic sheet is pressed towards the far end, the near end of the elastic sheet is collapsed towards the annular main body. Further, in order to ensure that the device does not poison human tissues after entering the human body, the elastic element 3400 is made of a biocompatible polymer material or a metal material, preferably, medical stainless steel is used.

The specific operation of the elastic element 3400, as shown in fig. 24 and 25, if the current winding degree is observed to be too large, which indicates that the length of the released suture is too short, the rotating shaft 1400 is operated to move axially and distally until the limiting portion 1420 arranged at the distal end of the rotating shaft 1400 passes through the second fixing element 3223 and abuts against the stopping element 3300. Then, the force is applied to the shaft 1400, and the stop 3300 is driven by the force to move in a direction to compress the elastic member 3400, thereby gradually compressing the elastic member 3400 from the initial state shown in fig. 13 to a nearly flat thin nitinol sheet. At this time, the winding member 3200 and the stopper 3300 are separated from each other, and the winding member 3200 is controlled to rotate synchronously only by operating the rotating shaft 1400, so that the current winding degree is reduced, and the length of the released suture is increased. Similarly, if the current winding degree is observed to be too small, the released suture length is too long, and the adjustment process is opposite to the above process. After the real-time adjustment of the thread winding degree is completed, as shown in fig. 26 and 27, the rotating shaft 1400 is operated to move axially and proximally, so as to separate the stopping member 1420 disposed at the distal end of the rotating shaft 1400 from the stopping member 3300, at this time, the elastic member 3400 will rebound from the flat thin plate shape to the initial state shown in fig. 13 under the action of its own resilience, and in this process, the elastic member 3400 will drive the stopping member 3300 to move towards the thread winding member 3200 until the first stopping member 3310 disposed on the stopping member 3300 is inserted into the first stopping groove 3221 disposed on the base 3220, so that the stopping member 3300 is connected with the thread winding member 3200 in a plugging manner, thereby better achieving the locking of the current thread winding degree.

Further, in order to facilitate the operator to operate more accurately, as shown in fig. 15-23, a second position-limiting member 3222 is further disposed on the outer wall surface of the first position-limiting groove 3221, and as shown in fig. 17, a second position-limiting groove 3133 matched with the second position-limiting member 3222 is disposed on the flange 3132. Preferably, the outer wall surface of the first stopper groove 3221 is configured to have a half-open structure. Specifically, as shown in fig. 21 and 22, when the base 3220 of the winding element 3200 rotates relative to the flange 3132 under the action of the rotating shaft 1400, the second limiting member 3222 will firstly slide into the second limiting groove 3133, and then under the action of the rotating force, the edge of the second limiting groove 3133 will apply pressure to the second limiting member 3222, so as to force the second limiting member 3222 to change its shape and move in the direction inside the first limiting groove 3221, so as to realize that the second limiting member 3222 slides out of the second limiting groove 3133. In the above operation process, the damping of the second position-limiting member 3222 and the second position-limiting groove 3133 may change during a series of processes from sliding in to sliding out of the second position-limiting member 3222 due to deformation, and the damping change during the adjustment process may be fed back to the operator through the transmission of the rotating shaft 1400, so that the operator may more accurately complete the real-time adjustment of the suture winding degree.

As shown in fig. 28, the adjustable wire locking device of the present invention may be used for transcatheter mitral annuloplasty. Firstly, a plurality of anchoring nails which are sequentially connected through a suture are implanted on the mitral valve annulus in sequence, the suture reaches the outside of the body along a guiding device, and the free ends of the suture sequentially pass through a threading hole 3135 arranged on the outer casing 3130, a threading hole 3211 arranged on the thread winding element 3200 and a threading hole 3135 arranged on the other side of the outer casing 3130. Then, the adjustable suture locking device is delivered along the suture until the implant 3000 reaches the valve annulus position, then the rotating shaft 1400 is operated to control the rotation of the suture member 3200, the winding degree of the suture is adjusted in real time, in the process of real-time adjustment, the opening 3111 of the mitral valve annulus changes along with the continuous beating of the heart, at the same time, the regurgitation condition of the mitral valve is observed through ultrasound, when the regurgitation disappears or reaches the slightest state, the rotating shaft 1400 stops rotating, the first limiting member 3310 on the stopping member 3300 is inserted into the first limiting groove 3221 of the suture member 3200 again, and the current winding degree is locked, so as to maintain the shape of the mitral valve annulus. Finally, the rotating shaft 1400, the threaded shaft 1300 and the sheath 1200 are operated to be disengaged from the implant 3000, thereby completing the mitral valve annuloplasty.

It will be appreciated that the adjustable wire locking device of the present invention may also be used for transcatheter tricuspid annuloplasty, as long as the appropriate access path is selected.

The adjustable locking thread device can also be used for implantation of artificial chordae tendineae of a mitral valve or a tricuspid valve, and after a suture which is implanted on a valve leaflet as the artificial chordae tendineae passes through an anchor which is anchored on a ventricular wall or a papillary muscle, the adjustable locking thread device can be used for adjusting the thread winding degree and locking the suture, and the details are not repeated.

Claims

1. An implant, comprising:

a housing assembly having an opening at a proximal end;

the far end of the winding piece and the near end of the stopping piece are far away or close to each other, so that the first limiting piece and the winding piece are separated from each other or the first limiting piece and the far end of the winding piece are in plug fit.

2. The implant of claim 1, wherein the distal end of the wire winding element is provided with a first limiting groove corresponding to the first limiting member, and the first limiting member is inserted into and engaged with the first limiting groove.

3. The implant of claim 1, wherein the housing assembly comprises: first shell, shell and second shell, the shell is cavity tubular structure, first shell install in the near-end of shell, the second shell install in the distal end of shell, stopper and winding part all install in the shell, the opening is seted up in on the first shell.

4. The implant of claim 3, wherein at least two first lugs are protruded from an edge of the retainer, and the housing defines a first groove for receiving the first lugs.

5. The implant of claim 3, wherein the wire winding member comprises: the wire winding part and with the base that the wire winding part distal end is connected, it is a plurality of first spacing groove interval distribution in on the base.

6. The implant of claim 5, wherein the inner wall surface of the housing is provided with a flange, and the outer wall surface of the seat abuts the flange.

7. The implant of claim 6, wherein a second retaining member is further disposed on the outer wall surface of the first retaining groove, and a second retaining groove is disposed on the flange and matches with the second retaining member.

8. The implant of claim 7, wherein the outer wall surface of the first retaining groove is configured to be a half-open structure.

9. The implant of claim 3, wherein the implant further comprises: the elastic piece is arranged in the shell assembly, and the proximal end of the elastic piece is abutted to the distal end of the stopper.

10. The implant of claim 9, wherein at least two second lugs are further protruded from edges of the elastic member, and a second groove for receiving the second lugs is formed in the housing.

11. The implant of claim 5, wherein the proximal spacer sleeve of the wire wrap portion has a first annular plate and a second annular plate, a distal end of the first annular plate abutting the proximal end of the first shell, and a proximal end of the second annular plate abutting the distal end of the first shell.

12. The implant of claim 5, wherein the wire wrapping portion is provided with a wire passing hole for passing a suture; and the shell is provided with a threading hole matched with the threading hole.

13. An adjustable wire locking device, characterized by comprising: a handle, a manipulating assembly, and the implant of any of claims 1-12, wherein a distal end of the manipulating assembly is removably coupled to a proximal end of the implant, and a proximal end of the manipulating assembly is coupled to the handle.

14. The adjustable wire locking device according to claim 13, wherein the operation assembly comprises a connecting member detachably connected to the implant, the connecting member is a hollow structure and gradually increases in diameter from a proximal end to a distal end.

15. The adjustable wire locking device according to claim 14, wherein a claw is protruded from a distal end of the connecting member, and a locking groove engaged with the claw is formed on the housing assembly of the implant.

16. The adjustable wire locking device according to claim 14, wherein the operating assembly comprises:

the distal end of the sheath tube is fixedly connected with the connecting piece;

the proximal end of the threaded shaft is movably arranged in the sheath, and the distal end of the threaded shaft is detachably connected with the winding part of the implant.

17. The adjustable wire locking device of claim 16, wherein the operating assembly further comprises: the rotating shaft is movably arranged in the threaded shaft in a penetrating mode, and the far end of the rotating shaft is detachably connected with the base of the implant.

18. The adjustable wire locking device according to claim 17, wherein a first fixing member is provided at a distal end of the rotating shaft extending out of the threaded shaft, and a second fixing member is provided on the base to be engaged with the first fixing member.

19. The adjustable wire locking device according to claim 18, wherein a limiting portion is further protruded from a distal end of the first fixing member.