Implant and adjustable locking wire device

Abstract

This application relates to an implant and an adjustable suture locking device. The implant includes a housing assembly, a suture winding member, and a stop member. The housing assembly has an opening at its proximal end; the suture winding member is installed within the housing assembly, with its proximal end movably passing through the opening; the stop member is connected to the housing assembly, and its proximal end has a first limiting member; wherein the distal end of the suture winding member and the proximal end of the stop member are either far apart or close together, such that the first limiting member is separated from the suture winding member or the first limiting member is inserted into the distal end of the suture winding member. The adjustable suture locking device includes this implant. The implant and adjustable suture locking device of this application can adjust the degree of suture winding in real time, ensuring that the suture is properly locked.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and in particular, relates to an implant and an adjustable locking wire device. Background Art

[0002] Annular dilatation is one of the most common causes of valvular heart disease. It can cause the valve leaflets to separate from each other during ventricular contraction, creating gaps and no longer close or coapt effectively, resulting in blood regurgitation and reduced blood output from the heart.

[0003] Annuloplasty for annular dilatation is an important surgical procedure for repairing the mitral or tricuspid valve. Its principle is to reduce the valve leaflet regurgitation caused by annular dilatation by shrinking the valve ring to reduce the valve orifice area of ​​the mitral or tricuspid valve so that the valve leaflets can fit together during ventricular contraction, thereby reducing or eliminating regurgitation. Although surgical annuloplasty can repair the valve ring very well, it has the disadvantages of large trauma, high risk, and slow patient recovery. In recent years, minimally invasive interventional annuloplasty via catheter has emerged. In the case of a beating heart, the mitral or tricuspid valve is annulated using a corresponding annuloplasty device. During the operation of minimally invasive interventional annuloplasty via catheter, it is usually necessary to anchor the anchor with sutures on the heart valve ring along the circumference of the annulus, and then use a locking device to tighten the sutures to achieve the purpose of repairing and shrinking the annulus. However, the existing locking device can only squeeze or wrap the sutures in one direction during the locking process to achieve continuous locking. However, when the operator realizes that the suture is locked too tightly, the suture can no longer be loosened in the suture locking device, making it impossible to adjust the tightness of the suture in real time, thus affecting the surgical effect and even causing the failure of the operation. Summary of the invention

[0004] The purpose of the present application is to provide an implant and an adjustable thread locking device to solve the technical problem in the prior art that after the suture of the thread locking device is locked, the tightness of the suture cannot be adjusted in real time.

[0005] To achieve the above object, the present invention provides an implant in a first aspect, comprising:

[0006] A housing assembly having an opening at a proximal end;

[0007] A winding member is installed in the housing assembly, and a proximal end of the winding member is movably inserted into the opening;

[0008] A stopper connected to the housing assembly, wherein a first limiting member is disposed at a proximal end of the stopper;

[0009] The distal end of the winding member and the proximal end of the stop member are moved away from or close to each other, so that the first limiting member and the winding member are separated from each other or the first limiting member and the distal end of the winding member are plugged in and matched.

[0010] To achieve the above objectives, the second aspect of the present invention provides an adjustable wire locking device, comprising: a handle, an operating assembly and the aforementioned implant, wherein the distal end of the operating assembly is detachably connected to the proximal end of the implant, and the proximal end of the operating assembly is connected to the handle.

[0011] Compared with the prior art, the present invention has at least the following beneficial effects:

[0012] The present invention provides an implant and an adjustable thread locking device, which can adjust the tightness of the suture in real time by controlling the entire thread locking device. During the suture locking process, if it is observed that the current winding is too large, it means that the length of the suture released at this time is too short. When adjusting, first separate the distal end of the winding member from the proximal end of the stopper, and then rotate the winding member to reduce the current winding degree. Similarly, if it is observed that the current winding is too small, it means that the length of the suture released at this time is too long, and the adjustment direction is opposite to the above. When it is observed in real time that the current winding degree is the required winding degree and the degree of suture locking is appropriate, the first limiter on the stopper is controlled to be plugged and matched with the distal end of the winding member, so as to lock the adjusted winding degree. If the winding degree of the suture still needs to be adjusted again, this process can be repeated many times. Therefore, the design of the present application can adjust the winding degree in real time, so that the degree of suture locking is appropriate, and the surgical effect is guaranteed. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] 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.

[0014] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0015] Figure 1 This is an overall view of the adjustable wire locking device shown in the first embodiment.

[0016] Figure 2 This is a cross-sectional view of an operating component shown in the first embodiment.

[0017] Figure 3 This is a schematic diagram of the structure of the rotating shaft shown in Example 1.

[0018] Figure 4 This is a cross-sectional view of the winding member and the stop member in the separated state shown in the first embodiment.

[0019] Figure 5 for Figure 4 A partial enlarged view of position A in the middle;

[0020] Figure 6 This is a cross-sectional view of the winding member and the stop member in the connected state shown in the first embodiment.

[0021] Figure 7 for Figure 6 A partial enlarged view of position B in the middle.

[0022] Figure 8 This is a schematic diagram of the structure of the winding component shown in Example 1.

[0023] Fig. 9 This is a schematic structural diagram of a housing assembly according to the first embodiment.

[0024] Fig.10 This is a schematic diagram of the structure of the stopper shown in the first embodiment.

[0025] Fig.11 This is a schematic diagram of the structure of the stopper and the housing in the first embodiment.

[0026] Fig.12 This is a schematic diagram of the structure of the rotating shaft shown in the second embodiment.

[0027] Fig.13 This is a schematic diagram of the structure of the elastic member shown in the second embodiment.

[0028] Fig.14 This is a schematic diagram of the structure of the elastic member and the housing in the second embodiment.

[0029] Fig.15 This is a schematic diagram of the structure of the winding component shown in the second embodiment.

[0030] Fig.16 for Fig.15 Top view of the .

[0031] Fig.17 This is a schematic diagram of the structure of the housing shown in the second embodiment.

[0032] Fig.18 for Fig.17 A partial enlarged view of the C position in the middle.

[0033] Fig.19 This is a schematic diagram of the structure of the housing and the winding component after assembly according to the second embodiment.

[0034] Fig. 20 for Fig.19A partial enlarged view of the D position in the middle.

[0035] Fig.21 This is a schematic diagram of the deformation of the second limiting member when the winding member rotates relative to the housing in the second embodiment.

[0036] Fig. 22 for Fig.21 A partial enlarged view of position E in the middle.

[0037] Fig.23 This is an exploded view of the implant shown in the second embodiment.

[0038] Fig.24 This is a cross-sectional view of the winding member and the stop member in the separated state shown in the second embodiment.

[0039] Fig.25 for Fig.24 A partial enlarged view of the F position in the middle.

[0040] Fig.26 This is a cross-sectional view of the winding member and the stop member in the connected state shown in the second embodiment.

[0041] Fig. 27 for Fig.26 A partial enlarged view of the G position in the middle.

[0042] Fig.28 Schematic diagram of an adjustable lockwire device for mitral valve annuloplasty. DETAILED DESCRIPTION

[0043] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0044] It should be understood that the directions or positional relationships indicated by “front”, “back”, “up”, “down”, “left”, “right”, “longitudinal”, “horizontal”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “head”, “tail”, etc. are based on the directions or positional relationships shown in the drawings, and are constructed and operated in specific directions. They are only for the convenience of describing the technical solution, and do not indicate that the device or element referred to must have a specific direction. Therefore, they should not be understood as limiting the present invention.

[0045] It should also be noted that, unless otherwise clearly specified and limited, the terms such as "installed", "connected", "connected", "fixed", "set" and the like should be understood in a broad sense, for example, it can be fixedly connected, detachably connected, or integrated; it can be directly connected, or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there may be one or more intermediate elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0046] In the description of the present invention, it still needs to be explained 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; the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction.

[0047] Embodiment 1

[0048] like Figure 1 As shown, the present invention exemplarily provides an adjustable locking wire device, including: an operating component 1000, a handle 2000 and an implant 3000, the distal end of the operating component 1000 is detachably connected to the proximal end of the implant 3000, and the proximal end of the operating component 1000 is connected to the handle 2000.

[0049] Specifically, Figure 2 As shown, in order to ensure a stable connection between the operating component 1000 and the implant 3000, the operating component 1000 includes: a connector 1100, the connector 1100 is detachably connected to the implant 3000, and the connector 1100 is a hollow structure, and the diameter gradually increases from the proximal end to the distal end. Further, in order to ensure that the instrument will not cause toxicity to human tissue after entering the human body, the connector 1100 is made of a biocompatible polymer material or a metal material. Preferably, medical stainless steel is used.

[0050] Specifically, in order to further realize the detachable connection between the operating component 1000 and the implant 3000, a claw 1110 is protruded from the distal end of the connector 1100, and a slot cooperating with the claw 1110 is provided on the shell component 3100 of the implant 3000. The distal end of the connector 1100 realizes a stable detachable connection with the implant 3000 through the cooperation between the claw 1110 and the slot.

[0051] Specifically, the operating assembly 1000 further includes: a sheath 1200, the distal end of which is fixedly connected to the connector 1100. Preferably, the sheath 1200 is configured as a hollow multi-layer composite tube, the inner layer of which is a PTFE inner film layer, the middle layer is a metal braided reinforcement mesh, and the outer layer is covered with Pebax material, which can transmit torque over a long distance.

[0052] Furthermore, the operation assembly 1000 further includes: a threaded shaft 1300, the proximal end of the threaded shaft 1300 is movably arranged in the sheath tube 1200, and the distal end of the threaded shaft 1300 is detachably connected to the winding portion 3210 of the implant 3000. Preferably, the threaded shaft 1300 is a flexible section with a certain length, which can bend and transmit torque, and the distal end of the threaded shaft 1300 is provided with a section of thread that can cooperate 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 tubular cavity formed after the sheath tube 1200 and the connector 1100 are assembled. Optionally, the proximal end of the connector 1100 and the inner wall of the distal end of the sheath tube 1200 can be concentrically matched and fastened by bonding, welding, clamping, screwing, etc.

[0053] Specifically, Figure 2 and Figure 3 As shown, the operating assembly 1000 also includes: a rotating shaft 1400, which is movably arranged in the threaded shaft 1300, and the distal end of which is detachably connected to the implant 3000. Furthermore, the distal end of the rotating shaft 1400 extending out of the threaded shaft 1300 is provided with a first fixing member 1410, and the implant 3000 is provided with a second fixing member 3223 that matches the first fixing member 1410. Preferably, the first fixing member 1410 and the second fixing member 3223 are configured as matching protrusions and mounting holes. In this embodiment, as shown in FIG. Figure 2-Figure 7 As shown, the first fixing member 1410 is configured as a rectangular segment, and the second fixing member 3223 is configured as a rectangular hole. Optionally, the rotating shaft 1400 can be configured as a solid rod or a hollow tube, and the distal end has a flexible segment of a certain length, so that it can bend and transmit torque.

[0054] It can be understood that when the operating component 100 cooperates with the implant 3000, the sheath 1200 is first stably connected to the housing 3130 of the implant 3000 through the cooperation of the claw 1110 and the slot, and then the detachable connection between the rotating shaft 1400 and the winding member 3200 of the implant 3000 is realized by utilizing the cooperation of the first fixing member 1410 and the second fixing member 3223. Thereafter, the threaded connection between the threaded shaft 1300 and the winding member 3200 of the implant 3000 is realized through the meshing threads, thereby controlling the rotation of the winding member 3200 of the implant 3000 by driving the rotating shaft 1400 to rotate, thereby locking or loosening the suture threaded on the winding member 3200.

[0055] In this embodiment, if Figure 1 As shown, the handle 2000 includes a shell and a first operating switch 2100, a second operating switch 2200, a third operating switch 2300 and a fourth operating switch 2400 arranged on the shell, wherein the first operating switch 2100 is used to control the relative position between the threaded shaft 1300 and the sheath 1200, the second operating switch 2200 is used to control the relative position between the rotating shaft 1400 and the sheath 1200, the third operating switch 2300 is used to drive the threaded shaft 1300 to rotate, and the fourth operating switch 2400 is used to control the rotating shaft 1400 to rotate, thereby controlling the locking and loosening 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, as well as the control structures of the first operating switch 2100 and the third operating switch 2300 for driving the threaded shaft 1300 and the control structures of the second operating switch 2200 and the fourth operating switch 2400 for the rotating shaft 1400 are all prior arts, and therefore will not be elaborated herein.

[0056] Specifically, Figure 4-Figure 11 As shown, the present invention discloses an implant 3000, comprising: a housing assembly 3100, the proximal end of which is provided with an opening 3111; a winding member 3200, which is installed in the housing assembly 3100, and the proximal end of the winding member 3200 is movably arranged in the opening 3111; a stopper 3300, which is connected to the housing assembly 3100, and the proximal end of the stopper 3300 is provided with a first stopper 3310, and the first stopper 3310 can be plugged and matched with the distal end of the winding member 3200. The proximal end of the winding member 3200 extends out from the opening 3111 to drive the distal end of the winding member 3200 to separate from the proximal end of the stopper 3300, and the proximal end of the winding member 3200 retracts into the opening 3111 to drive the first stopper 3310 on the winding member 3200 to connect with the proximal end of the stopper 3300.

[0057] Specifically, the shell assembly 3100 includes: a first shell 3110, an outer shell 3130 and a second shell 3120. The outer shell 3130 is a hollow cylindrical structure. The first shell 3110 is installed at the proximal end of the outer shell 3130, and the second shell 3120 is installed at the distal end of the outer shell 3130. The winding member 3200 and the stop member 3300 are both installed in the outer shell 3130, and the opening 3111 is opened on the first shell 3110.

[0058] Furthermore, in order to ensure that the device does not cause toxicity to human tissue after entering the human body, the first shell 3110, the outer shell 3130 and the second shell 3120 are all made of biocompatible polymer materials or metal materials, preferably medical stainless steel.

[0059] Specifically, the winding member 3200 includes: a winding portion 3210 and a base 3220 connected to the distal end of the winding portion 3210, and a thread hole 3211 for threading the suture is provided on the winding portion 3210. Preferably, the thread hole 3211 passes through the winding portion 3210, and preferably, the axial direction of the thread hole 3211 is perpendicular to the axial direction of the winding portion 3210, and the number is at least one pair. When threading, one end of the suture first passes through the thread hole 3211, and then the winding member 3200 is controlled by the rotating shaft 1400 to achieve winding the suture on the outer wall surface of the winding portion 3210, thereby reducing the length of the suture and locking the suture.

[0060] Optionally, a threading hole 3135 matching the threading hole 3211 is provided on the shell 3130. Preferably, the threading holes 3135 are arranged as two pairs of four threading holes arranged in parallel. Further, the threading holes 3135 are arranged on opposite sides of the outer circumference of the shell 3130. When threading, one end of the suture first enters the inner cavity of the shell 3130 through the threading hole 3135, and then passes through the threading hole 3211 provided on the winding part 3210. The suture is wound on the outer wall surface of the winding part 3210 by rotating the rotating shaft 1400 to control the winding member 3200. After the winding is completed, if it is observed that the current winding is too large, it means that the length of the suture released at this time is too short. It is only necessary to control the rotating shaft 1400 to rotate the winding member 3200, so as to reduce the current winding degree and adjust and increase the length of the suture released. Similarly, if it is observed that the current winding thread length is too small, it means that the length of the suture released at this time is too long, and the adjustment process can be the opposite of the above.

[0061] Furthermore, in order to ensure that the winding member 3200 is stably installed in the housing assembly 3100, the inner wall surface of the housing 3130 is further provided with a flange 3132, and the outer wall surface of the base 3220 abuts against the flange 3132. Furthermore, in order to ensure that the device does not cause toxicity to human tissue after entering the human body, the winding member 3200 is made of a biocompatible polymer material or a metal material, preferably, medical stainless steel.

[0062] Specifically, the main body of the stopper 3300 is preferably configured as a metal sheet that is in close contact with the distal end surface of the winding member 3200. At least two first ears 3320 are convexly provided at the edge of the stopper 3300, and a first groove 3131 for accommodating the first ears 3320 is provided on the housing 3130. The stopper 3300 achieves a stable connection with the housing 3130 and prevents the stopper 3300 from rotating relative to the housing 3130 through the cooperation between the first ears 3320 and the first groove 3131.

[0063] Furthermore, in order to ensure that the device does not cause toxicity to human tissue after entering the human body, the stopper 3300 is made of biocompatible polymer material or metal material, preferably, medical stainless steel.

[0064] Specifically, the first limiter 3310 is arranged at the proximal end of the stopper 3300, and the first limiter 3310 is arranged at the distal end of the winding member 3200 accordingly. The shapes of the first limiter 3310 and the first limiter groove 3221 correspond one to one, and the first limiter 3310 and the first limiter groove 3221 are adapted to form a limiter structure. Preferably, two first limiters 3310 are arranged, and the two first limiters 3310 are arranged at the two ends of the stopper 3300, respectively, and a plurality of first limiter grooves 3221 are arranged, and the plurality of first limiter grooves 3221 are distributed at intervals on the base 3220, so as to ensure that the winding member 3200 can be stably connected with the stopper 3300 through the plug-in cooperation between the first limiter groove 3221 and the first limiter 3310, so as to lock the current winding degree.

[0065] Furthermore, the depth of the first groove 3131 arranged on the outer shell 3130 is greater than the thickness of the first ear 3320 arranged at the edge of the stop member 3300. This design can ensure that the stop member 3300 can only move along the axis relative to the outer shell 3130, and will not rotate relative to the outer shell 3130, thereby ensuring the stable plug-in fit between the first limit member 3310 arranged on the stop member 3300 and the first limit groove 3221 arranged on the winding member 3200.

[0066] It is understandable that after the current winding degree is locked, if it is observed that the current winding is too large, indicating that the length of the suture released at this time is too short, the winding member 3200 is pulled to move in the direction of the opening 3111 extending out of the housing assembly 3100 to drive the distal end of the winding member 3200 to separate from the proximal end of the stop member 3300, that is, the first limit member 3310 is pulled out from the first limit groove 3221, and then the winding member 3200 is rotated by controlling the rotating shaft 1400 to reduce the current winding degree. After that, it is only necessary to push the winding member 3200 to move in the direction of the retracted opening 3111 to drive the distal end of the winding member 3200 to be plugged and connected with the proximal end of the stop member 3300, that is, the first limit member 3310 is inserted into the first limit groove 3221 again, so as to achieve the locking of the winding degree adjusted in real time. Similarly, if the current winding degree is observed to be too small, it means that the length of the suture released at this time is too long, and the adjustment process can be the opposite of the above. Therefore, the scheme of this example can achieve real-time adjustment of the winding degree after the suture is locked, thereby ensuring the surgical effect.

[0067] The specific working process is as follows:

[0068] like Figure 4 and Figure 5As shown, in the initial state, the winding member 3200 and the stopper 3300 are in a separated state. Therefore, after the sheath tube 1200 and the housing 3130 are assembled through the cooperation between the claw 1110 and the slot, the threaded shaft 1300 is first rotated to make the threaded connection between the threaded shaft 1300 and the winding portion 3210. For the convenience of understanding, for example, the clockwise rotation of the threaded shaft 1300 relative to the winding member 3200 is defined as a loosening state; conversely, the counterclockwise rotation of the threaded shaft 1300 relative to the winding member 3200 is defined as a tightening state. It can be understood that the clockwise rotation of the threaded shaft 1300 relative to the winding member 3200 can also be defined as a tightening state, and the counterclockwise rotation of the threaded shaft 1300 relative to the winding member 3200 can be defined as a loosening state. The direction is not understood as a limitation to this solution. Then, the driving shaft 1400 is extended from the distal end of the threaded shaft 1300 until the first fixing member 1410 disposed on the shaft 1400 is inserted into the second fixing member 3223 disposed on the winding member 3200, so as to realize the stable connection between the shaft 1400 and the winding member 3200. Then, one end of the suture is passed through the threading hole 3135 into the inner cavity of the housing 3130, and passes through the threading hole 3211 disposed on the winding part 3210 and the threading hole 3135 on the opposite side of the housing 3130. At this time, by rotating the shaft 1400, the winding member 3200 is driven to rotate synchronously, so that the suture is wound on the outer wall surface of the winding part 3210, and at this time, the current winding degree can be locked. If it is observed that the current winding degree is too large, it means that the length of the suture released at this time is too short. It is only necessary to withdraw the threaded shaft 1300 to separate the first limit member 3310 from the first limit groove 3221, and then reversely rotate the winding member 3200 through the rotating shaft 1400 to reduce the current winding degree. Similarly, if it is observed that the current winding degree is too small, it means that the length of the suture released at this time is too long, and the adjustment direction can be opposite to the above adjustment direction. Repeat the above operation until it is observed in real time that the current winding degree is the required winding degree, then stop driving the rotating shaft 1400 to rotate. At this time, the threaded shaft 1300 is used to push the winding member 3200 toward the distal end so that the thread member 3200 moves in the direction of the retracted opening 3111, so as to insert the first limit member 3310 into the first limit groove 3221 again, thereby locking the current winding degree. After completing the real-time adjustment of the tightness of the suture, pull the rotating shaft 1400 proximally until the first fixing member 1410 is separated from the second fixing member 3223; then drive the threaded shaft 1300 to disengage the threaded shaft 1300 and the winding member 3200; finally, withdraw the sheath 1200 proximally to separate the claw 1110 from the slot to disengage the sheath and the shell assembly 3100, leaving only the implant 3000 in the patient's body.

[0069] Embodiment 2

[0070] like Fig.12 as well as Figure 25-28 As shown, compared with the adjustable wire locking device of the first embodiment, the adjustable wire locking device provided in this embodiment is different in that:

[0071] A limiting portion 1420 is also provided at the distal end of the first fixing member 1410. The limiting portion 1420 is set as a cylindrical section with a diameter smaller than the width of the rectangular hole. Specifically, during operation, the rotating shaft 1400 will be connected to the winding member 3200 through the cooperation of the first fixing member 1410 and the second fixing member 3223, and then the limiting portion 1420 of the rotating shaft 1400 will abut against the stopper 3300, so that the stopper 3300 is controlled to move in a direction close to the second shell 3120 under the action of the rotating shaft 1400.

[0072] like Figure 14-28 As shown, compared with the implant 3000 of the first embodiment, the implant 3000 provided in this embodiment has the following differences:

[0073] Specifically, the proximal end of the winding part 3210 is provided with a first annular plate 3230 and a second annular plate 3240, the distal end of the first annular plate 3230 abuts against the proximal end of the first shell 3110, and the proximal end of the second annular plate 3240 abuts against the distal end of the first shell 3110. With the design of this embodiment, the proximal end of the winding member 3200 can be limited in the opening 3111 of the first shell 3110, so that during transportation or operation, when the entire implant 3000 is turned upside down, the winding member 3200 will not move axially relative to the shell 3130, and can only rotate freely along the spatial track between the first annular plate 3230 and the second annular plate 3240. Preferably, the first annular plate 3230 and the second annular plate 3240 are respectively connected to the proximal end of the winding part 3210 by laser welding. Furthermore, in order to ensure that the device does not cause toxicity to human tissue after entering the human body, the first annular plate 3230 and the second annular plate 3240 are both made of biocompatible polymer materials or metal materials, preferably medical stainless steel.

[0074] Specifically, the implant 3000 also includes: an elastic member 3400, which is installed in the shell assembly 3100, and the proximal end of the elastic member 3400 is abutted against the distal end of the stop member 3300. Furthermore, at least two second ears 3410 are protruding from the edge of the elastic member 3400, and a second groove 3134 for accommodating the second ears 3410 is opened on the shell 3130. Preferably, the elastic member 3400 is a thin plate of nickel-titanium alloy as a whole, and the second ears 3410 cooperate with the second grooves 3134 to achieve a stable connection between the elastic member 3400 and the shell 3130. After heat treatment, the elastic member 3400 appears as follows in a natural state (i.e., a state without force). Fig.13 In the form shown, specifically, the elastic member 3400 includes an annular body and a plurality of spring pieces arranged at intervals along the circumferential direction on the annular body, each spring piece extends from the annular body to the proximal end and toward the direction close to the central axis of the annular body, and there is a gap between two adjacent spring pieces; when the spring piece is subjected to a pressure toward the distal end, its proximal end will collapse toward the annular body. Furthermore, in order to ensure that the device will not cause toxicity to human tissue after entering the human body, the elastic member 3400 is made of biocompatible polymer material or metal material, preferably, medical stainless steel.

[0075] The specific working process of the elastic member 3400 is as follows: Fig.24 and Fig.25 As shown in FIG. 1 , if the current winding length is too large, it means that the length of the suture released at this time is too short. At this time, the rotating shaft 1400 is operated to move axially to the distal end until the limiting portion 1420 set at the distal end of the rotating shaft 1400 passes through the second fixing member 3223 and conflicts with the stopper 3300. Then, the force is continuously applied to the rotating shaft 1400, and the stopper 3300 will move in the direction of compressing the elastic member 3400 under the driving force of the above force, gradually moving the elastic member 3400 from the position shown in FIG. Fig.13 The initial state shown is compressed into a nearly flat nickel-titanium alloy sheet. At this time, the winding member 3200 and the stop member 3300 will be in a separated state. It is only necessary to operate the rotating shaft 1400 to control the synchronous rotation of the winding member 3200, so as to reduce the current winding degree and increase the length of the released suture. Similarly, if it is observed that the current winding degree is too small, it means that the length of the suture released at this time is too long, and the adjustment process can be the opposite of the above process. After completing the real-time adjustment of the suture winding degree, as shown in FIG. Fig.26 and 27 As shown, the rotating shaft 1400 only needs to be moved toward the axial proximal end to separate the limiting portion 1420 disposed at the distal end of the rotating shaft 1400 from the stopper 3300. At this time, the elastic member 3400 will rebound from the flat thin plate shape to the shape of the elastic member 3400 under the action of its own rebound force. Fig.13 In the initial state shown, during this process, the elastic member 3400 drives the stop member 3300 to move in the direction of the winding member 3200 until the first limiting member 3310 arranged on the stop member 3300 is inserted into the first limiting groove 3221 arranged on the base 3220, so that the stop member 3300 is plugged and connected with the winding member 3200, thereby better realizing the locking of the current winding degree.

[0076] Furthermore, in order to facilitate the operator to operate more accurately, such as Figure 15-23 As shown, a second limiting member 3222 is further provided on the outer wall of the first limiting groove 3221. Fig.17As shown, the flange 3132 is provided with a second limiting groove 3133 that matches the second limiting member 3222. Preferably, the outer wall surface of the first limiting groove 3221 is set to a semi-open structure. Fig.21 and Fig. 22 As shown, when the base 3220 of the winding member 3200 rotates relative to the flange 3132 under the action of the rotating shaft 1400, the second stopper 3222 will first slide into the second stopper groove 3133, and then under the action of the rotation force, the edge of the second stopper groove 3133 will give pressure to the second stopper 3222, forcing the second stopper 3222 to deform and move toward the inside of the first stopper groove 3221, so as to achieve the second stopper 3222 sliding out of the second stopper groove 3133. In the above operation process, since the damping of the second stopper 3222 and the second stopper groove 3133 from sliding in to the deformation of the second stopper 3222 and the sliding apart will change, the damping change of the adjustment process can be fed back to the operator through the transmission of the rotating shaft 1400, so that the operator can more accurately complete the real-time adjustment of the suture winding degree.

[0077] like Fig.28 As shown, the adjustable locking wire device of the present invention can be used for transcatheter mitral annuloplasty. First, multiple anchors connected in sequence by sutures are implanted in the mitral valve ring in sequence, and the sutures are passed through the threading hole 3135 set in the housing 3130, the threading hole 3211 set in the winding member 3200, and the threading hole 3135 set on the other side of the housing 3130 in sequence. Then the adjustable thread locking device is conveyed along the suture until the implant 3000 reaches the valve ring position, and then the rotating shaft 1400 is operated to control the winding member 3200 to rotate, and the winding degree of the suture is adjusted in real time. During the real-time adjustment process, the opening 3111 of the mitral valve ring will change with the continuous beating of the heart. At this time, the regurgitation of the mitral valve is observed by ultrasound. When the regurgitation disappears or reaches the mildest state, the rotating shaft 1400 is stopped, and the first limiting member 3310 on the stop member 3300 is inserted into the first limiting groove 3221 of the winding member 3200 again to lock the current winding degree to maintain the shape of the mitral valve ring. Finally, the rotating shaft 1400, the threaded shaft 1300 and the sheath 1200 are all released from the implant 3000 to complete the mitral valve annuloplasty.

[0078] It is understandable that the adjustable lock-wire device of the present invention can also be used for transcatheter tricuspid annuloplasty as long as a suitable interventional pathway is selected.

[0079] The adjustable wire locking device of the present invention can also be used for artificial chord implantation of the mitral valve or tricuspid valve. After the sutures implanted as artificial chords on the valve leaflets pass through anchors anchored on the ventricular wall or papillary muscles, the adjustable wire locking device of the present invention can be used to adjust the winding degree and lock the sutures, which will not be repeated here.

Claims

1. An adjustable wire locking device, characterized in that: The implant comprises a handle, an operating assembly and an implant. The distal end of the operating assembly is detachably connected to the proximal end of the implant, and the proximal end of the operating assembly is connected to the handle. The operating assembly comprises a connecting piece, a rotating shaft, a sheath tube and a threaded shaft. The connecting piece is detachably connected to the implant. The connecting piece is a hollow structure. The distal end of the sheath tube is fixedly connected to the connecting piece. The proximal end of the threaded shaft is movably inserted into the sheath tube, and the distal end is detachably connected to the winding part of the implant. The rotating shaft is movably inserted into the threaded shaft. The implant comprises: A housing assembly having an opening at a proximal end; A winding member is installed in the housing assembly, and a proximal end of the winding member is movably inserted into the opening; A stopper connected to the housing assembly, wherein a first limiting member is disposed at a proximal end of the stopper; The distal end of the winding member and the proximal end of the stop member are moved away from or close to each other, so that the first limiting member and the winding member are separated from each other or the first limiting member and the distal end of the winding member are plugged in and matched.

2. The adjustable wire locking device according to claim 1, characterized in that: A first limiting groove is arranged at the distal end of the winding member corresponding to the first limiting member, and the first limiting member is plug-fitted into the first limiting groove.

3. The adjustable wire locking device according to claim 1, characterized in that: The shell assembly includes: a first shell, an outer shell and a second shell. The outer shell is a hollow cylindrical structure. The first shell is installed at the proximal end of the outer shell, and the second shell is installed at the distal end of the outer shell. The stopper and the winding member are both installed in the outer shell, and the opening is opened on the first shell.

4. The adjustable wire locking device according to claim 3, characterized in that: At least two first ears are protruding from the edge of the stopper, and a first groove for accommodating the first ears is formed on the shell.

5. The adjustable wire locking device according to claim 3, characterized in that: The winding member comprises: a winding portion and a base connected to the distal end of the winding portion, and a plurality of the first limiting grooves are distributed on the base at intervals.

6. The adjustable wire locking device according to claim 5, characterized in that: The inner wall surface of the shell is provided with a flange, and the outer wall surface of the base abuts against the flange.

7. The adjustable wire locking device according to claim 6, characterized in that: A second limiting member is also provided on the outer wall surface of the first limiting groove, and a second limiting groove matching with the second limiting member is provided on the flange.

8. The adjustable wire locking device according to claim 7, characterized in that: The outer wall surface of the first limiting groove is configured as a semi-open structure.

9. The adjustable wire locking device according to claim 3, characterized in that: The implant also includes an elastic member installed in the housing assembly, and a proximal end of the elastic member abuts against a distal end of the stop member.

10. The adjustable wire locking device according to claim 9, characterized in that: At least two second ears are protruding from the edge of the elastic member, and a second groove for accommodating the second ears is formed on the shell.

11. The adjustable wire locking device according to claim 5, characterized in that: The proximal end of the winding portion is spaced apart by a first annular plate and a second annular plate, the distal end of the first annular plate abuts against the proximal end of the first shell, and the proximal end of the second annular plate abuts against the distal end of the first shell.

12. The adjustable wire locking device according to claim 5, characterized in that: The winding part is provided with a thread hole for threading the suture; the shell is provided with a threading hole matched with the thread hole.

13. The adjustable wire locking device according to claim 1, characterized in that: A claw is protruding from the distal end of the connector, and a slot cooperating with the claw is provided on the housing component of the implant.

14. The adjustable wire locking device according to claim 1, characterized in that: The operating assembly also includes: the distal end of the rotating shaft is detachably connected to the base of the implant.

15. The adjustable wire locking device according to claim 14, characterized in that: A first fixing piece is arranged at the distal end of the rotating shaft extending out of the threaded shaft, and a second fixing piece matching with the first fixing piece is arranged on the base.

16. The adjustable wire locking device according to claim 15, characterized in that: A limiting portion is also protruded from the distal end of the first fixing member.

Images