Releasable assembly for securing the push rod
By designing a releaseable assembly and a separate delivery clamping device for fastening the push rod, the problem of minimally invasive treatment of the heart structure changes is solved, and a non-invasive clamping of the leaflets is achieved, reducing the risk of postoperative pressure and complications, and improving the success rate of delivery and implantation.
Patent Information
- Application Number
- CN202011158457.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2020-10-26
- Publication Date
- 2025-08-15
- Estimated Expiration
- 2040-10-26
AI Technical Summary
Existing minimally invasive transcatheter mitral regurgitation products require changes in the heart structure, resulting in postoperative stress and discomfort, and traditional surgical procedures are highly invasive and have high complications.
A releaseable assembly for fastening the push rod is designed, including a base, a stretching unit and a fastener. The tension unit is controlled to tighten or relax in the positioning member through the control unit to achieve locking or release of the push rod, and cooperate with a separate conveying clamping device to clamp the leaflets, reducing the device length to improve the conveying capacity.
The non-invasive clamping of the heart structure of the minimally invasive treatment was achieved, reducing structural changes to the heart, reducing postoperative pressure and complication risks, and improving the success rate of device delivery and implantation.
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Figure CN113440309B_ABST
Abstract
Description
Technical Field
[0001] The embodiments of the present application relate to the technical field of medical devices, and in particular to a releasable assembly for fastening a push rod. Background Art
[0002] A common ailment of the mitral, tricuspid, aortic, and pulmonary valves is valvular insufficiency. For example, during systole, a portion of the blood in the left ventricle flows back through the insufficiency of the mitral valve into the left atrium. The left atrium receives both this regurgitated blood and blood from the pulmonary veins, significantly increasing blood volume and pressure in the left atrium, leading to left atrial hypertrophy.
[0003] During cardiac diastole, more blood flows from the left atrium to the left ventricle, causing the left ventricle to hypertrophy due to enhanced contraction. After evolving from the compensatory period to the decompensated period, both the left atrium and the left ventricle suffer from heart failure, followed by pulmonary congestion, pulmonary hypertension, right ventricular hypertrophy, right atrial hypertrophy, right heart failure, and systemic congestion.
[0004] Traditional treatment options include aggressive surgery or palliative medication to combat inevitable heart failure. Surgical options also include valve replacement and valvuloplasty. Among these surgical options, typical open-chest surgery is highly invasive, requiring extracorporeal circulation and carrying a high complication rate and infection risk. Many patients cannot tolerate the significant surgical risks and are left helplessly awaiting death.
[0005] Currently, there are few minimally invasive transcatheter treatments for mitral and tricuspid regurgitation approved in China. These products require changes to the structure of the heart during the healing process, which brings great pressure and discomfort to the heart after surgery. Summary of the Invention
[0006] In view of the above problems, the present application provides a releasable assembly for fastening a push rod to overcome the above problems or at least partially solve the above problems.
[0007] According to an embodiment of the present invention, a releasable component for fastening a push rod is provided, wherein the push rod is connected to a control unit, and the releasable component includes: a base, which is provided with a first channel suitable for the push rod to pass through, and a positioning member suitable for positioning the stretching unit; a stretching unit, which is respectively connected to the control unit and the positioning member; and a fastener, which is connected to the stretching unit, wherein the stretching unit is controlled by the control unit to be tightened or relaxed in the positioning member, so that the stretching unit drives the fastener to be in a loosened state or a locked state, thereby releasing or locking the push rod.
[0008] According to one embodiment of the present invention, the stretching unit is controlled by the control unit so that when the stretching unit is tightened in the positioning member, the stretching unit drives the fastener to a loose state and the push rod is released; when the stretching unit is relaxed in the positioning member, the fastener is in a locked state and the push rod is locked.
[0009] According to an embodiment of the present invention, the positioning member includes a first threading hole suitable for the stretching unit to pass through, and the stretching unit passes through the bottom of the base through the first threading hole.
[0010] According to one embodiment of the present invention, the fastener includes a locking plate, which is arranged in the base, and the locking plate is provided with: a locking hole, through which the push rod passes; and a second threading hole, which is used to pass through the stretching unit; the locking plate has a locked state and a loosened state, when the stretching unit is in a relaxed state, the locking hole locks the push rod; when the stretching unit is in a tensioned state, the locking hole deforms to loosen the push rod, and the push rod is movable in the locking hole.
[0011] According to one embodiment of the present invention, when the stretching unit is in a relaxed state, the vertical distance between the axis of the second threading hole and the axis of the positioning member is L; when the stretching unit is in a tensioned state, the vertical distance between the axis of the second threading hole and the axis of the positioning member is W, where W<L.
[0012] According to one embodiment of the present invention, the locking plate has a horizontal surface, the locking hole and the second threading hole are both provided on the horizontal surface and pass through the horizontal surface, and when the stretching unit is in a relaxed state, the locking hole is a square hole; when the stretching unit is in a tensioned state, the locking hole is a diamond hole.
[0013] According to one embodiment of the present invention, the locking plate has a first surface and a second surface, the second surface is connected to the first surface, and the second surface can rotate relative to the first surface, the locking hole is provided on the second surface, and the second threading hole is provided on the first surface, when the stretching unit is in a relaxed state, the second surface forms an angle θ with the first surface; when the stretching unit is in a tensioned state, the second surface rotates relative to the first surface, so that the angle θ becomes larger.
[0014] It can be seen from the above technical solution that the releasable component of the embodiment of the present application cooperates with the base, the stretching unit and the fastener to tighten or relax the stretching unit in the positioning member, so that the stretching unit drives the fastener to be in a locked state and a loosened state to lock or release the push rod.
[0015] Furthermore, the detachable delivery and clamping device of the present application can reduce the length of the detachable delivery and clamping device in the closed state, thereby improving the device's ability to navigate corners and facilitating delivery and implantation. After the detachable delivery and clamping device is implanted within the heart structure, the clamping assembly is in an expanded state, with the upper and lower clamping assemblies separated and opened. The positions of the upper and lower clamping assemblies are adjustable to facilitate their cooperation to effectively capture and clamp the valve leaflets. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.
[0017] Figure 1 This is a structural diagram of a separate conveying and clamping device of the present application;
[0018] Figure 2 This is a structural schematic diagram of a separate conveying and clamping device in a closed state according to the present application;
[0019] Figure 3 This is a structural schematic diagram of a separate conveying and clamping device in the present application in an expanded state;
[0020] Figure 4 This is a structural schematic diagram of a separate conveying and clamping device in the present application in an expanded state;
[0021] Figure 5 This is a schematic structural diagram of an upper clamping assembly of a separate conveying clamping device of the present application when it is retracted downward;
[0022] Figure 6 This is a structural diagram of a separate conveying and clamping device of the present application, in which the lower clamping assembly is retracted into the upper clamping assembly;
[0023] Figure 7 This is a schematic structural diagram of a separate delivery clamping device placed in a sheath assembly of the present application;
[0024] Figure 8 This is a structural schematic diagram of an angle when the occluder of a separate conveying and clamping device of the present application moves downward and connects with the base;
[0025] Figure 9 This is a structural schematic diagram of another angle of the occluder of the separate conveying and clamping device of the present application when the occluder moves downward and connects with the base;
[0026] Figure 10 yes Figure 9 Sectional view along line AA;
[0027] Figure 11-12 This is a schematic structural diagram of different angles of a lower clamping assembly of a separate conveying clamping device of the present application during the retraction process;
[0028] Figure 13 yes Figure 12 A cross-sectional view along the central axis;
[0029] Figure 14 This is a schematic structural diagram of a separate conveying and clamping device of the present application, in which the clamping assembly is retracted into the occluder;
[0030] Figure 15 is a top view of an embodiment of a releasable component of the present application;
[0031] Figure 16 yes Figure 15 Cross-sectional view along line BB;
[0032] Figure 17-18 This is a structural schematic diagram of a locking plate in a locked state according to an embodiment of a releasable assembly of the present application;
[0033] Figure 19-20 This is a structural schematic diagram of a locking plate in a relaxed state according to an embodiment of a releasable assembly of the present application;
[0034] Figure 21-Figure 27 This is a schematic diagram of the process structure of an embodiment of the use of a separate conveying and clamping device of the present application;
[0035] Figures 28-31 This is a partial process structural diagram of another embodiment of the use of a separate conveying and clamping device of the present application;
[0036] Figure 32 This is a structural schematic diagram of a base and a locking plate of a separate conveying and clamping device of the present application, wherein the locking plate is in a locked state;
[0037] Figure 33 This is a structural schematic diagram of a base and a locking piece of a separate conveying clamping device of the present application, wherein the locking piece is in a released state;
[0038] Figure 34 is a schematic diagram of another embodiment of a releasable component of the present application;
[0039] Figure 35 is a schematic diagram of a locking piece of another embodiment of a releasable assembly of the present application;
[0040] Figure 36-Figure 37This is a structural schematic diagram of another embodiment of a releasable assembly of the present application, in which the locking piece is in a locked state and a released state respectively.
[0041] Component number
[0042] 100: detachable conveying and clamping device;
[0043] 1: Occluder;
[0044] 2: Clamping assembly, 21: Upper clamping assembly, 211: Upper clamping arm, 22: Lower clamping assembly, 221: Lower clamping arm, 222: Rotating arm;
[0045] 3: push rod assembly, 31: first push rod, 32: second push rod, 33: push rod;
[0046] 41: first pull wire, 42: second pull wire;
[0047] 5: base, 51: first threading hole, 52: locking plate, 53: locking hole, 54: second threading hole;
[0048] 61: control device, 62: conveying device;
[0049] 7: Sheath assembly
[0050] 8: Heart structure, 81: Valve leaflets, 82: Left atrium, 83: Left ventricle. DETAILED DESCRIPTION
[0051] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the technical solutions 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 only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the embodiments of the present application, all other embodiments obtained by ordinary technicians in this field should fall within the scope of protection of the embodiments of the present application.
[0052] The following describes a detachable delivery and clamping device 100 according to an embodiment of the present invention with reference to the accompanying drawings. The detachable delivery and clamping device 100 can be implanted in a cardiac structure 8 to clamp valve leaflets 81 and close the regurgitant gap between the valve leaflets 81. The detachable delivery and clamping device 100 can include a clamping assembly 2.
[0053] Combine Figures 1-14 As shown, the clamping assembly 2 may include an upper clamping assembly 21 and a lower clamping assembly 22. The upper clamping assembly 21 and the lower clamping assembly 22 are correspondingly arranged, and the leaflet 81 is clamped between the upper clamping assembly 21 and the lower clamping assembly 22. The cooperation of the upper clamping assembly 21 and the lower clamping assembly 22 can effectively capture and clamp the leaflet 81.
[0054] The upper clamping component 21 and the lower clamping component 22 can be separated and matched, that is, the upper clamping component 21 and the lower clamping component 22 are independently set, that is, the upper clamping component 21 and the lower clamping component 22 can be separated and moved independently, and the positions of the upper clamping component 21 and the lower clamping component 22 are adjusted respectively so as to effectively capture the leaflet 81. When clamping the leaflet 81, the leaflet 81 can be clamped between the upper clamping component 21 and the lower clamping component 22 through the cooperation of the upper clamping component 21 and the lower clamping component 22.
[0055] The clamping assembly 2 has an expanded state and a closed state and is movable between the expanded state and the closed state, that is, the clamping assembly 2 can be switched between the expanded state and the closed state. When the clamping assembly 2 is in the closed state, Figure 6 He Ru Figure 7 As shown, one of the upper clamping assembly 21 and the lower clamping assembly 22 is retracted into the other of the upper clamping assembly 21 and the lower clamping assembly 22 to be suitable for being placed in the sheath assembly 7. When the clamping assembly 2 is in the expanded state, the upper clamping assembly 21 and the lower clamping assembly 22 are separated and expanded and can be adjusted to be suitable for clamping the leaflet 81.
[0056] Specifically, the detachable transport clamping device 100 can cooperate with the sheath tube assembly 7. For example, the sheath tube assembly 7 may include a tearable sheath, a transport sheath and an outer sheath. The detachable transport clamping device 100 can be pushed from the tearable sheath into the outer sheath through the transport sheath, the tearable sheath is torn off, and the outer sheath is left to form a passage. It moves to a designated position from the passage established by the outer sheath, and then pushes out the outer sheath through the transport sheath, while keeping the detachable transport clamping device 100 in a closed state.
[0057] In other words, when the clamping assembly 2 is in the closed state, it is suitable for cooperating with the sheath assembly 7 so as to be implanted into the cardiac structure 8 through the sheath assembly 7. At this time, one of the upper clamping assembly 21 and the lower clamping assembly 22 is retracted into the other. In this way, not only can the volume of the sheath assembly 7 and the detachable delivery clamping device 100 be reduced, but the length of the detachable delivery clamping device 100 in the closed state can also be reduced, thereby improving the cornering ability of the detachable delivery clamping device 100 and facilitating the delivery and implantation of the detachable delivery clamping device 100. After the detachable delivery clamping device 100 is implanted into the cardiac structure 8, the clamping assembly 2 is in the expanded state, the upper clamping assembly 21 and the lower clamping assembly 22 are separated and opened, and the positions of the upper clamping assembly 21 and the lower clamping assembly 22 are adjustable so that the upper clamping assembly 21 and the lower clamping assembly 22 cooperate to effectively capture and clamp the valve leaflets 81.
[0058] In some embodiments of the present invention, the upper clamping assembly 21 may include at least two upper clamping arms 211, and the lower clamping assembly 22 may include at least two lower clamping arms 221 cooperating with the upper clamping arms 211. That is, the upper clamping assembly 21 may include two or more upper clamping arms 211, and the lower clamping assembly 22 may include two or more lower clamping arms 221. The upper clamping arm 211 is arranged above the lower clamping arm 221 and corresponds one-to-one with the lower clamping arm 221. The upper clamping arm 211 and the lower clamping arm 221 are separable, and the upper clamping arm 211 and the lower clamping arm 221 can be separately controlled and adjusted, thereby facilitating the capture of the clamping leaflet 81.
[0059] like Figure 2 as well as Figure 5-Figure 7 As shown, when the clamping assembly 2 is in the closed state, the upper clamping arm 211 rotates downward and contracts, and the lower clamping arm 221 moves upward and is retracted to the outside of the upper clamping arm 211, as shown in FIG. Figure 3-Figure 4 When the clamping assembly 2 is in the expanded state, the lower clamping arm 221 is separated from the upper clamping arm 211 and expanded, while the upper clamping arm 211 is released and rotated upward to return to the expanded state.
[0060] Optionally, the upper clamping arm 211 and the lower clamping arm 221 are rotatable and movable in the up and down directions to be suitable for capturing the clamping leaflet 81. In this way, when capturing the leaflet 81, the upper clamping arm 211 and the lower clamping arm 221 can be adjusted, and the upper clamping arm 211 and the lower clamping arm 221 are rotated and moved in the up and down directions to adjust the clamping space between the upper clamping arm 211 and the lower clamping arm 221 so that the leaflet 81 can be located between the upper clamping arm 211 and the lower clamping arm 221. When the leaflet 81 is between the upper clamping arm 211 and the lower clamping arm 221, the distance between the upper clamping arm 211 and the lower clamping arm 221 and the angle relative to the horizontal direction or the vertical direction are adjusted so that the clamping assembly 2 can effectively capture the clamping leaflet 81.
[0061] Furthermore, the detachable conveying and clamping device 100 also includes a push rod assembly 3, which includes multiple push rods and has an adjustable axial length. The clamping assembly 2 is disposed on the push rod assembly 3. By adjusting the push rod assembly 3, the clamping assembly 2 can be adjusted so that the clamping assembly 2 can move in the vertical direction. The upper clamping assembly 21 and the lower clamping assembly 22 can be disposed at different positions of the push rod assembly 3. By moving different push rods of the push rod assembly 3, the upper clamping assembly 21 and the lower clamping assembly 22 can be moved relative to each other in the vertical direction.
[0062] Optionally, the detachable conveying clamping device 100 also includes a first pull wire 41, one end of the upper clamping arm 211 is rotatably connected to the push rod assembly 3, and the other end of the upper clamping arm 211 is formed as a free end. The first pull wire 41 is connected to the free end of the upper clamping arm 211 to drive the upper clamping arm 211 to rotate. Since one end of the upper clamping arm 211 is fixed, the free end of the upper clamping arm 211 can be pulled in the up and down directions by the first pull wire 41, thereby driving the upper clamping arm 211 to rotate, changing the angle between the upper clamping arm 211 and the push rod assembly 3 to adjust the position of the upper clamping arm 211.
[0063] The detachable conveying clamping device 100 also includes a rotating arm 222, which is arranged below the lower clamping arm 221 and between the push rod assembly 3 and the lower clamping arm 221 and is rotatably connected to the lower clamping arm 221 and the push rod assembly 3 respectively. The rotating arm 222 rotates to drive the lower clamping arm 221 to rotate relative to the push rod assembly 3. Specifically, there are at least two rotating arms 222, and each rotating arm 222 is connected to the lower clamping arm 221 one by one, and the two ends of each rotating arm 222 are respectively connected to the push rod assembly 3 and the corresponding lower clamping arm 221, wherein each rotating arm 222 is tilted, and the lower end of the rotating arm 222 is rotatably connected to the end of the push rod assembly 3, and the upper end of the rotating arm 222 is rotatably connected to the lower clamping arm 221. In this way, when the push rod assembly 3 is adjusted, the push rod assembly 3 drives the lower end of the rotating arm 222 to move up and down, and the inclination angle of the rotating arm 222 changes. Since the arm length of the rotating arm 222 is unchanged, the upper end of the rotating arm 222 moves to drive the lower clamping arm 221 to rotate, so that the inclination angle of the lower clamping arm 221 relative to the push rod assembly 3 can be adjusted to better capture the clamping leaflet 81.
[0064] like Figure 3-Figure 7 As shown, the push rod assembly 3 may include: a first push rod 31, a second push rod 32 and a push rod 33. The upper clamping assembly 21 is arranged on the first push rod 31 and is detachably connected to the first push rod 31. The first push rod 31 moves to drive the upper clamping assembly 21 to move in the up and down directions. The second push rod 32 is installed in the first push rod 31 and is slidably connected to the first push rod 31. The push rod 33 is detachably connected to the second push rod 32, and the rotating arm 222 is movably connected to the push rod 33. In this way, the first push rod 31 moves relative to the second push rod 32, which can drive the upper clamping assembly 21 to move in the up and down directions. The movement of the push rod 33 can drive the rotating arm 222 to move to drive the lower clamping assembly 22 to expand or contract. The upper clamping assembly 21 is detachably connected to the first push rod 31, and the push rod 33 is detachably connected to the second push rod 32. In this way, after the detachable sealing clamping device 100 is dissociated, the first push rod 31 and the second push rod 32 can be withdrawn, leaving the clamping assembly 2 and the push rod 33, the rotating arm 222 equal in the heart structure 8. At this time, the clamping assembly 2 clamps the leaflet 81.
[0065] The lower clamping assembly 22 also includes a base 5 and a second pull wire 42. The push rod 33 passes through the first channel 90 on the base 5 and is detachably connected to the second push rod 32. The base 5 is provided with a first threading hole 51 suitable for the second pull wire 42 to pass through. The second pull wire 42 passes through the bottom of the base 5 from the first threading hole 51 and both ends of the second pull wire 42 are connected to the operating handle. The lower clamping arm 221 is rotatably provided on the base 5. In other words, the base 5 is mounted on the push rod 33, and both ends of the second pull wire 42 are connected to the operating handle. The base 5 is provided with at least two first threading holes 51. The second pull wire 42 passes through the bottom of the base 5 from one first threading hole 51 and then comes out from the other first threading hole 51. The lower end of the lower clamping arm 221 is rotatably connected to the base 5. In this way, the position of the base 5 can be controlled and adjusted by the second pull wire 42, thereby controlling the position of the lower clamping arm 221 relative to the push rod 33. Combined with Figure 1 、 Figures 8-10 As shown, when the position of the second pull wire 42 remains unchanged, the position of the lower clamping arm 221 remains unchanged and is in an open state. At this time, the first push rod 31 is pushed downward to drive the upper clamping assembly 21 to move toward the lower clamping assembly 22 until the upper clamping assembly 21 is connected to the base 5; when the second push rod 32 drives the push rod 33 to move toward the base 5, the push rod 33 is connected to the rotating arm 222 to drive the rotating arm 222 to move, and the upper end of the rotating arm 222 is connected to the lower clamping arm 221 to drive the lower clamping arm 221 to rotate.
[0066] like Figure 15 and Figure 16 As shown, the detachable conveying clamping device 100 also includes a locking plate 52, which is arranged in the base 5. The locking plate 52 is provided with a locking hole 53 and a second threading hole 54. The push rod 33 passes through the locking hole 53 and the base 5 and is connected to the second push rod 32. The second threading hole 54 is used to pass the second pull wire 42.
[0067] The locking piece 52 has a locking state and a loose state. When the second pull line 42 is in a loose state, the locking hole 53 is in a locking state to lock the push rod 33, and the push rod 33 cannot move in the locking hole 53. Figure 32 As shown, at this time, the vertical distance between the axis of the second threading hole 54 and the axis of the first threading hole 51 is L; when the second pull wire 42 is in a tensioned state, the locking piece 52 is in a loose state, the locking hole 53 is deformed to loosen the push rod 33, and the push rod 33 can move in the locking hole 53, as shown in FIG. Figure 33As shown, at this time, the vertical distance between the axis of the second threading hole 54 and the axis of the first threading hole 51 is W, where W<L, that is, the central axis of the second threading hole 54 does not coincide with the central axis of the first threading hole 51, and the central axis of the second threading hole 54 is arranged adjacent to the push rod 33 relative to the central axis of the first threading hole 51, so that when the second pull wire 42 is in a relaxed state, the locking hole 53 locks the push rod 33, and the push rod 33 cannot move at this time. When the second pull wire 42 is tightened, the second threading hole 54 and the first threading hole 51 are aligned, the second pull wire 42 drives the locking plate 52 to deform, and the locking hole 53 becomes larger, so that the push rod 33 can move up and down in the locking hole 53.
[0068] Moreover, the push rod 33 is inserted into the lock hole 53 and the base 5 and is detachably connected to the second push rod 32 , so that the second push rod 32 can be easily withdrawn during dissociation.
[0069] In other embodiments of the present invention, the detachable delivery and clamping device 100 may further include an occluder 1 for blocking the regurgitant gap between the leaflets 81, thereby reducing regurgitation, and a clamping assembly 2 for capturing and clamping the leaflets 81. Figures 1-14 As shown, the occluder 1 is arranged above the clamping assembly 2. In this way, after the clamping assembly 2 clamps the leaflets 81, the occluder 1 can block the regurgitant gap between the leaflets 81 and reduce regurgitation.
[0070] In some embodiments of the present invention, the upper clamping assembly 21 is disposed above the lower clamping assembly 22, and the occluder 1 is disposed above the upper clamping assembly 21. When the clamping assembly 2 is in the closed state, the upper clamping assembly 21 is retracted downward, and the lower clamping assembly 22 is retracted upward outside the upper clamping assembly 21. When the clamping assembly 2 switches to the expanded state, the lower clamping assembly 22 separates from the upper clamping assembly 21 and expands. The upper clamping assembly 21 becomes expanded after losing the constraint of the lower clamping assembly 22.
[0071] The upper clamping assembly 21 may include at least two upper clamping arms 211, and the lower clamping assembly 22 may include at least two lower clamping arms 221 cooperating with the upper clamping arms 211. That is to say, the upper clamping assembly 21 may include two or more upper clamping arms 211, and the lower clamping assembly 22 may include two or more lower clamping arms 221. The upper clamping arm 211 is arranged above the lower clamping arm 221 and is arranged one-to-one with the lower clamping arm 221. The upper clamping arm 211 and the lower clamping arm 221 are separable, and the upper clamping arm 211 and the lower clamping arm 221 can be controlled and adjusted separately, thereby facilitating the capture of the clamping leaflet 81.
[0072] like Figure 2 as well as Figure 5-Figure 7As shown, when the clamping assembly 2 is in the closed state, the upper clamping arm 211 rotates downward and contracts, and the lower clamping arm 221 moves upward and is retracted to the outside of the upper clamping arm 211, as shown in FIG. Figure 3-Figure 4 When the clamping assembly 2 is in the expanded state, the lower clamping arm 221 is separated from the upper clamping arm 211 and expanded, while the upper clamping arm 211 is released and rotated upward to return to the expanded state.
[0073] Optionally, the upper clamping arm 211 and the lower clamping arm 221 are rotatable and movable in the up and down directions to be suitable for capturing the clamping leaflet 81. In this way, when capturing the leaflet 81, the upper clamping arm 211 and the lower clamping arm 221 can be adjusted, and the upper clamping arm 211 and the lower clamping arm 221 are rotated and moved in the up and down directions to adjust the clamping space between the upper clamping arm 211 and the lower clamping arm 221 so that the leaflet 81 can be located between the upper clamping arm 211 and the lower clamping arm 221. When the leaflet 81 is between the upper clamping arm 211 and the lower clamping arm 221, the distance between the upper clamping arm 211 and the lower clamping arm 221 and the angle relative to the horizontal direction or the vertical direction are adjusted so that the clamping assembly 2 can effectively capture the clamping leaflet 81.
[0074] Furthermore, the upper clamping assembly 21 can be fixedly connected to the occluder 1. The upper clamping assembly 21 is connected to the lower end of the occluder 1. The upper clamping assembly 21 includes multiple upper clamping arms 211. The multiple upper clamping arms 211 are distributed along the circumference of the occluder. When the upper clamping assembly 211 is in the expanded state, the multiple upper clamping arms 211 are expanded and the occluder 1 is located in the opening formed by the expansion of the multiple upper clamping arms 211.
[0075] Furthermore, the detachable delivery and clamping device 100 also includes a push rod assembly 3, which includes multiple push rods and has an adjustable axial length. The occluder 1 and the upper clamping assembly 21 are both provided on the push rod assembly 3. By adjusting the push rod assembly 3, the occluder 1 and the upper clamping assembly 21 can be adjusted, so that the upper clamping assembly 21 and the occluder 1 can be moved in the vertical direction. The upper clamping assembly 21 and the lower clamping assembly 22 can be provided at different positions of the push rod assembly 3. By moving different push rods of the push rod assembly 3, the upper clamping assembly 21, the lower clamping assembly 22 and the occluder 1 can be moved relative to each other in the vertical direction.
[0076] The detachable transport clamping device 100 also includes a first pull wire 41. One end of the upper clamping arm 211 is rotatably connected to the push rod assembly 3, and the other end of the upper clamping arm 211 is formed as a free end. The first pull wire 41 is connected to the free end of the upper clamping arm 211 to drive the upper clamping arm 211 to rotate. Since one end of the upper clamping arm 211 is fixed, the first pull wire 41 can pull the free end of the upper clamping arm 211 in the vertical direction, thereby driving the upper clamping arm 211 to rotate, changing the angle between the upper clamping arm 211 and the push rod assembly 3 to adjust the position of the upper clamping arm 211. For example, the first pull wire 41 can be used to pull multiple upper clamping arms 211 toward the position of the upward occluder 1 to adjust the position of the upper clamping arms 211 to facilitate clamping of the valve leaflets 81.
[0077] The detachable conveying clamping device 100 also includes a rotating arm 222, which is obliquely connected between the push rod assembly 3 and the lower clamping arm 221 and is rotatably connected to the lower clamping arm 221 and the push rod assembly 3 respectively. The rotating arm 222 rotates to drive the lower clamping arm 221 to rotate relative to the push rod assembly 3.
[0078] like Figure 3-Figure 7 As shown, the push rod assembly 3 may include: a first push rod 31, a second push rod 32 and a push rod 33. The occluder 1 and the upper clamping assembly 21 are arranged on the first push rod 31 and are detachably connected to the first push rod 31. The first push rod 31 moves to drive the occluder 1 and the first clamping assembly 2 to move in the up and down directions. The second push rod 32 is installed in the first push rod 31 and is slidably connected to the first push rod 31. The push rod 33 is detachably connected to the second push rod 32, and the rotating arm 222 is movably connected to the push rod 33. In this way, the first push rod 31 moves relative to the second push rod 32, which can drive the upper clamping assembly 21 and the occluder 1 to move in the up and down directions. The movement of the push rod 33 can drive the rotating arm 222 to move. The occluder 1 and the upper clamping assembly 21 are detachably connected to the first push rod 31, and the push rod 33 is detachably connected to the second push rod 32. In this way, after the detachable occluding clamping device 100 is dissociated, the first push rod 31 and the second push rod 32 can be withdrawn, leaving the clamping assembly 2 and the occluder 1 as well as the push rod 33 and the rotating arm 222 equal in the heart structure 8. At this time, the clamping assembly 2 clamps the leaflets 81, and the occluder 1 blocks the regurgitant gap between the leaflets 81.
[0079] The lower clamping assembly 22 also includes a base 5 and a second pull wire 42. The push rod 33 passes through the base 5 and is detachably connected to the second push rod 32. The base 5 is provided with a first threading hole 51 suitable for the second pull wire 42 to pass through. The second pull wire 42 passes through the bottom of the base 5 from the first threading hole 51 and both ends of the second pull wire 42 are connected to the operating handle. The lower clamping arm 221 is rotatably provided on the base 5. In other words, the base 5 is mounted on the push rod 33, and both ends of the second pull wire 42 are connected to the operating handle. The base 5 is provided with at least two first threading holes 51. The second pull wire 42 passes through the bottom of the base 5 from one first threading hole 51 and then comes out from another first threading hole 51. The lower end of the lower clamping arm 221 is rotatably connected to the base 5. In this way, the position of the base 5 can be controlled and adjusted by the second pull wire 42, thereby controlling the position of the lower clamping arm 221 relative to the push rod 33. Combined with Figure 1 、 Figures 8-10 As shown, when the position of the second pull wire 42 remains unchanged, the position of the lower clamping arm 221 remains unchanged and is in an open state. At this time, the first push rod 31 is pushed downward to drive the occluder 1 and the clamping assembly 2 to move toward the lower clamping assembly 22 until the occluder 1 and the upper clamping assembly 21 are connected to the base 5; when the second push rod 32 drives the push rod 33 to move toward the base 5, the push rod 33 is connected to the rotating arm 222 to drive the rotating arm 222 to move, and the upper end of the rotating arm 222 is connected to the lower clamping arm 221 to drive the lower clamping arm 221 to rotate.
[0080] like Figure 15 and Figure 16 As shown, the detachable conveying clamping device 100 also includes a locking plate 52, which is arranged in the base 5. The locking plate 52 is provided with a locking hole 53 and a second threading hole 54. The push rod 33 passes through the locking hole 53 and the base 5 and is connected to the second push rod 32; the second threading hole 54 is used to pass the second pull wire 54. The locking plate 52 has a locked state and a loosened state. When the second pull wire 42 is in a loose state, the locking hole 53 locks the push rod 33, and the push rod 33 cannot move in the locking hole 53. Figure 32 As shown, at this time, the vertical distance between the axis of the second threading hole 54 and the axis of the first threading hole 51 is L; when the second pull wire 42 is in a tensioned state, the lock hole 53 is deformed to release the push rod 33, and the push rod 33 can move in the lock hole 53, as shown in FIG. Figure 33As shown, at this time, the vertical distance between the axis of the second threading hole 54 and the axis of the first threading hole 51 is W, where W<L, that is, the central axis of the second threading hole 54 does not coincide with the central axis of the first threading hole 51, and the central axis of the second threading hole 54 is arranged adjacent to the push rod 33 relative to the central axis of the first threading hole 51, so that when the second pull wire 42 is in a relaxed state, the locking hole 53 is in a locked state to lock the push rod 33, and the push rod 33 cannot move at this time. When the second pull wire 42 is tightened, the second threading hole 54 and the first threading hole 51 are aligned, the second pull wire 42 drives the locking plate 52 to deform, and the locking hole 53 becomes larger, so that the push rod 33 can move up and down in the locking hole 53.
[0081] Moreover, the push rod 33 is inserted into the lock hole 53 and the base 5 and is detachably connected to the second push rod 32 , so that the second push rod 32 can be easily withdrawn during dissociation.
[0082] A detachable conveying clamping device 100 according to a specific example of the present invention will be described below with reference to the accompanying drawings.
[0083] Combine Figures 1-20 As shown in the figure, the detachable conveying and clamping device 100 includes an occluder 1, a clamping assembly 2, a push rod assembly 3, a rotating arm 222, a first pull wire 41, a second pull wire 42, a base 5 and a locking piece 52, etc.
[0084] Specifically, the push rod assembly 3 may include a first push rod 31, a second push rod 32 and a push rod 33 that are coaxially arranged, wherein the first push rod 31 is slidably connected to the second push rod 32 and is installed on the second push rod 32, and the push rod 33 is arranged below the second push rod 32 and is detachably connected to the second push rod 32.
[0085] The clamping assembly 2 includes an upper clamping arm 211 and a lower clamping arm 221. The upper clamping arm 211 and the lower clamping arm 221 are arranged in a one-to-one correspondence and the upper clamping arm 211 is arranged above the lower clamping arm 221. Figures 1-13 As shown, there can be two upper clamping arms 211 and two lower clamping arms 221, respectively. The two upper clamping arms 211 are respectively arranged on both sides of the radial direction of the push rod assembly 3, wherein the two upper clamping arms 211 are respectively fixedly connected to the occluder 1 and can be shaped into an open state according to material properties.
[0086] The occluder 1 and the upper clamping arm 211 are installed on the first push rod 31 and are detachably connected to the first push rod 31. The sliding of the first push rod 31 can drive the occluder 1 and the upper clamping arm 211 to move. The first pull wire 41 is connected to the upper end of the upper clamping arm 211. The position of the upper end of the upper clamping arm 211 can be adjusted by pulling the first pull wire 41. When the first pull wire 41 is tightened, the upper end of the upper clamping arm 211 moves toward the direction of the first push rod 31. When the first pull wire 41 is released, the upper clamping arm 211 returns to its initial open state. Adjusting the length of the first pull wire 41 can adjust the opening position of the upper clamping arm 211, so that the leaflet 81 can be repeatedly captured to achieve effective capture of the leaflet 81.
[0087] like Figure 1 As shown, Figure 1 FIG. 4 shows that the upper clamping arm 211 can be pulled by the first pull wire 41 to move between being retracted to the first push rod 31 and being away from the first push rod 31 . Figure 1 The position of the first pull wire 41 and the upper clamping arm 211 when they are in the unfolded state, Figure 1 The middle first pull wire 41 ′ and the upper clamping arm 211 ′ are in a state when the first pull wire 41 is pulled and moves to another position.
[0088] The base 5 is mounted on the push rod 33, the locking plate 52 is arranged in the base 5 and is provided with a locking hole 53 suitable for the push rod 33 to pass through, wherein the locking plate 52 can be formed of an elastic material, and the shape of the locking hole 53 is variable, so that the push rod 33 can be locked and released, the base 5 is provided with a first threading hole 51, the locking plate 52 is provided with a second threading hole 54, the second pull wire 42 passes through the first threading hole 51 and the second threading hole 54 to pass through the bottom of the base 5, wherein the two ends of the second pull wire 42 are respectively connected to the operating handle, and the position of the base 5 and the lower clamping arm 221 can be controlled by the second pull wire 42.
[0089] The locking plate 52 has a horizontal surface, and the locking hole 53 and the second threading hole 54 are both provided on the horizontal surface and pass through the plane. When the second pull wire 42 is in a relaxed state, the locking hole 53 is a square hole; when the second pull wire 42 is in a tightened state, the locking hole 53 is a diamond hole.
[0090] Specifically, when the second pull wire 42 is loosened, the locking plate 52 locks the push rod. When the second pull wire 42 is tightened, the second pull wire 42 is straightened. Since there is a certain gap between the central axes of the first threading hole 51 and the second threading hole 54, when the second pull wire 42 is straightened, the second threading hole 54 moves outward, and the second pull wire 42 drives the locking plate 52 to deform, thereby the locking hole 53 is deformed and enlarged, for example, Figures 17-20As shown, when the locking plate 52 is in the locked state, the locking hole 53 can be formed into a diamond shape. When the locking plate 52 is deformed, the locking hole 53 gradually changes from a diamond shape to a nearly square shape, thereby increasing the size of the locking hole 53, allowing the locking plate 52 to change from the locked state to the loose state, thereby allowing the push rod 33 to move up and down within the locking hole 53. The locked shape and the deformed shape of the locking hole 53 are not limited to diamond and square, and can also be any other suitable shape.
[0091] The lower end of the lower clamping arm 221 is rotatably connected to the base 5. For example, the lower end of the lower clamping arm 221 can be connected to the base 5 by a shaft hole and a rotating shaft. The rotating arm 222 is tilted below the lower clamping arm 221. The lower end of the rotating arm 222 is rotatably connected to the lower end of the push rod 33, and the upper end of the rotating arm 222 is rotatably connected to the lower clamping arm 221. Figures 8-14 As shown, when the lower clamping arm 221 and the upper clamping arm 211 are in a clamping state, the first push rod 31 drives the occluder 1 to move toward the base 5 to connect with the base 5, wherein the occluder 1 is adapted to be engaged with the base 5 to facilitate the connection and fixation of the occluder 1 to the base 5. When the second push rod 32 drives the push rod 33 to move toward the base 5, the lower end of the push rod 33 is connected to the lower end of the rotating arm 222 to drive the rotating arm 222 to move, and the upper end of the rotating arm 222 is connected to the lower clamping arm 221 to drive the lower clamping arm 221 to close and retract toward the occluder 1.
[0092] The following describes the use process and method of the detachable conveying and clamping device 100 according to an embodiment of the present invention with reference to the accompanying drawings.
[0093] The detachable delivery clamping device 100 can be connected to the delivery device 62 and the control device 61, wherein the control device 61 can be used to control the target direction of the instrument, the delivery device 62 is used to move the instrument to approach the target point, and the detachable delivery clamping device 100 is used to be implanted in the heart structure 8.
[0094] like Figure 21 As shown, the detachable transport clamping device 100 reaches the left atrium 82 through the control device 61 and the transport device 62. At this time, the detachable transport clamping device 100 is stabilized in the left atrium 82 by the control device 61 and the transport device 62. At this time, the detachable transport clamping device 100 is in the position shown in FIG. Figure 2 and Figure 6 As shown in the closed state. Figure 22 Shown and combined Figure 3 and Figure 4 As shown, the second pull wire 42 passes through the base 5 and the locking plate 52, and the second pull wire 42 is pulled. When the second pull wire 42 is tightened, the locking plate 52 opens, and the push rod 33 can move up and down in the locking hole 53. In this way, the base 5 moves toward the occluder 1 under the action of the second pull wire 42, and the lower clamping arm 221 connected to the base 5 opens.
[0095] like Figure 23 and combined Figure 1 As shown, the occluder 1 is connected to the clamping assembly 2 in the left atrium 82. Specifically, the clamping assembly 2 remains in an expanded state under the action of the second pull wire 42, the base 5 and the push rod 33. The occluder 1 moves toward the left ventricle 83 through the first push rod 31 until it moves to the lower end of the occluder 1 and is connected to the base 5.
[0096] like Figure 24 As shown, by adjusting the first pull line 41 to drive the upper clamping arm 211 to rotate, the upper clamping arm 211 is retracted toward the occluder 1; Figure 25 As shown, the detachable transport clamping device 100 is moved to the left ventricle 83 through the first push rod 31. At this time, the lower clamping arm 221 is in an expanded state. The occluder 1 and the clamping assembly 2 are adjusted by the transport device 62 and the first push rod 31 to be close to the edge of the lower surface of a leaflet 81.
[0097] like Figure 26 As shown, the length and tightness of the first pull line 41 are adjusted to control the capture state of an upper clamping arm 211 and a lower clamping arm 221. When the upper clamping arm 211 is adjusted to a suitable position, the first pull line 41 releases the upper clamping arm 211 to restore it to the expanded state. When the upper clamping arm 211 is restored, the upper surface edge of the leaflet 81 is pressed together. Specifically, the upper surface edge of the leaflet 81 can be better captured by operating the first pull line 41 multiple times.
[0098] like Figure 26 As shown, the tightness of the first pull wire 41 is adjusted to control the capture state of another group of upper clamping arms 211 and lower clamping arms 221. When the other first pull wire 41 is released, the upper clamping arms 211 of the other group resume pressing the upper surface edge of the other leaflet 81. The first pull wire 41 is adjusted by multiple operations to better capture the upper surface edge of the other leaflet 81.
[0099] like Figure 27 Shown and combined Figures 9-14 As shown, the first push rod 31 and the occluder 1 are stabilized by the conveying device 62, and the adjustment push rod 33 moves toward the occluder 1 and the base 5. The push rod 33 drives the rotating arm 222 to rotate to push the lower clamping arm 221 to close and retract toward the occluder 1, as shown in FIG. Figure 26 As shown, after the control device 61 and the conveying device 62 are separated, the first push rod 31 and the second push rod 32 are withdrawn, and only the clamping assembly 2, the occluder 1 and the rotating arm 222 are retained.
[0100] The following combination Figure 21-22 as well as Figures 28-31 Another use process and method of the detachable conveying clamping device 100 according to an embodiment of the present invention will be described.
[0101] The detachable delivery clamping device 100 can be connected to the delivery device 62 and the control device 61, wherein the control device 61 can be used to control the target direction of the instrument, the delivery device 62 is used to move the instrument to approach the target point, and the detachable delivery clamping device 100 is used to be implanted in the heart structure 8.
[0102] like Figure 21 As shown, the detachable transport clamping device 100 reaches the left atrium 82 through the control device 61 and the transport device 62. At this time, the detachable transport clamping device 100 is stabilized in the left atrium 82 by the control device 61 and the transport device 62. At this time, the detachable transport clamping device 100 is in the position shown in FIG. Figure 2 and Figure 6 As shown in the closed state. Figure 22 Shown and combined Figure 3 and Figure 4 As shown, the second pull wire 42 passes through the base 5 and the locking plate 52, and the second pull wire 42 is pulled. When the second pull wire 42 is tightened, the locking plate 52 opens, and the push rod 33 can move up and down in the locking hole 53. In this way, the base 5 moves toward the occluder 1 under the action of the second pull wire 42, and the lower clamping arm 221 connected to the base 5 opens.
[0103] like Figure 28 As shown, the clamping assembly 2 moves across the petal to the lower surface edge of the leaflet 81. When the clamping assembly 2 is in the expanded state, the lower clamping assembly 22 is moved as a whole to the lower surface edge of the leaflet 81 by the second push rod 32. Figure 29 As shown, after the lower clamping assembly 22 remains stable under the action of the push rod 33 and the conveying device 62, the occluder 1 and the upper clamping assembly 21 are moved to fit the lower clamping assembly 22 through the first push rod 31, and at the same time, the upper clamping assembly 21 captures the upper surface edge of the leaflet 81 during the movement.
[0104] like Figure 30 As shown, the position of the captured leaflet 81 is adjusted. Specifically, the opening and closing state of the upper clamping arm 211 is controlled by the tension of the first pull line 41 and the second pull line 42. When the first pull line 41 is released, the upper clamping arm 211 returns to the expanded state and presses the upper surface edge of the leaflet 81 during the recovery. The upper surface edge of the leaflet 81 can be better captured by operating the first pull line 41 multiple times. The clamping state of other upper clamping arms 211, first pull lines 41 and leaflets 81 can be adjusted in the same way.
[0105] Combine Figure 30 and Figure 31 As shown, the first push rod 31 and the occluder 1 are stabilized by the conveying device, and the push rod 33 is adjusted to move toward the occluder 1 and the base 5. The push rod 33 drives the rotating arm 222 to rotate to push the lower clamping arm 221 to close and retract toward the occluder 1. Figure 27As shown, after the control device 61 and the conveying device 62 are separated, the first push rod 31 and the second push rod 32 are withdrawn, and only the clamping assembly 2, the occluder 1 and the rotating arm 222 are retained.
[0106] In one embodiment of the present application, the stretching unit is a second pull wire. In one embodiment of the present application, the control unit is an operating handle, but the present application is not limited to the above embodiment. In one embodiment of the present application, the positioning member is a first threading hole.
[0107] like Figures 34-37 As shown, in another embodiment of the present application, the locking plate 52 has a first surface 521 and a second surface 522. The second surface 522 is connected to the first surface 521 and can rotate relative to the first surface 521. The locking hole 53 is provided on the second surface 522, and the second threading hole 54 is provided on the first surface 521. When the second pull wire 42 is in a relaxed state, the second surface 522 forms an angle θ with the first surface 521, and the locking plate 52 locks the push rod. When the second pull wire 42 is in a tensioned state, the second surface 522 rotates relative to the first surface 521, causing the angle θ to increase, and the locking plate 52 releases the push rod, allowing the push rod to move up and down. The second threading hole 54 can be one, two, or more.
[0108] When the second pull wire 42 is in a relaxed state, the vertical distance between the axis of the second threading hole 54 and the axis of the first threading hole 51 is L; when the second pull wire 42 is in a tightened state, the vertical distance between the axis of the second threading hole 54 and the axis of the first threading hole 51 is W, where W<L.
[0109] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, and not to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. These modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present application.
Claims
1. A releasable assembly for fastening a push rod connected to a control unit, characterized in that The releasable assembly comprises a base, a stretching unit and a fastener, wherein: The push rod includes a first push rod, a second push rod slidingly matched with the first push rod, and a third push rod arranged on the base, the first push rod is provided with an upper clamping assembly, one end of the upper clamping assembly is rotatably connected to the first push rod, and the other end of the upper clamping assembly is a free end; The base is provided with a first passage suitable for the third push rod to pass through, and a positioning member suitable for positioning the stretching unit, and the base is connected to the lower clamping assembly; The stretching unit is connected to the control unit and the positioning member respectively, and the stretching unit is positioned by the positioning member and passes through the bottom of the base; The fastener is connected to the stretching unit, In the conveying state, the free end of the upper clamping assembly is close to the end of the second push rod close to the base, and at least a portion of the upper clamping assembly is retracted inside the lower clamping assembly; When the first push rod slides relative to the second push rod, the upper clamping assembly slides axially relative to the lower clamping assembly to capture and clamp the leaflet; The stretching unit is controlled by the control unit to tighten or relax in the positioning member, so that the stretching unit drives the fastener to be in a loose state or a locked state, thereby releasing or locking the third push rod.
2. The releasable assembly according to claim 1, wherein: The stretching unit is controlled by the control unit so that when the stretching unit is tightened in the positioning member, the stretching unit drives the fastener to a loose state and the third push rod is released; when the stretching unit is relaxed in the positioning member, the fastener is in a locked state and the third push rod is locked.
3. The releasable assembly according to claim 1, wherein: The fastener includes a locking plate, which is arranged in the base and has: a lock hole, through which the third push rod passes; as well as a second threading hole, which is used to pass the stretching unit; The locking plate has a locked state and a released state. When the stretching unit is in a relaxed state, the locking hole locks the third push rod; when the stretching unit is in a tensioned state, the locking hole deforms to release the third push rod, and the third push rod is movable in the locking hole.
4. The releasable assembly according to claim 3, wherein: When the stretching unit is in a relaxed state, the vertical distance between the axis of the second threading hole and the axis of the positioning member is L; when the stretching unit is in a tightened state, the vertical distance between the axis of the second threading hole and the axis of the positioning member is W, where W<L.
5. The releasable assembly according to claim 4, wherein: The lower clamping assembly also includes a second pull wire, and the base is provided with a first threading hole suitable for the second pull wire to pass through. When the stretching unit is in a relaxed state, the locking hole locks the third push rod, and at this time, the vertical distance between the axis of the second threading hole and the axis of the first threading hole is L; when the stretching unit is in a tensioned state, the locking hole deforms to loosen the third push rod, and the third push rod is movable in the locking hole. At this time, the vertical distance between the axis of the second threading hole and the axis of the first threading hole is W, where W<L.
6. The releasable assembly according to claim 4, wherein: The locking plate has a horizontal surface, the locking hole and the second threading hole are both provided on the horizontal surface and pass through the horizontal surface, when the stretching unit is in a relaxed state, the locking hole is a square hole; when the stretching unit is in a tightened state, the locking hole is a diamond hole.
7. The releasable assembly according to claim 4, wherein: The locking plate has a first surface and a second surface, the second surface is connected to the first surface and can rotate relative to the first surface, the locking hole is provided on the second surface, and the second threading hole is provided on the first surface. When the stretching unit is in a relaxed state, the second surface forms an angle θ with the first surface; when the stretching unit is in a tensioned state, the second surface rotates relative to the first surface, so that the angle θ becomes larger.
Citation Information
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