A traction device for a degradable left atrial appendage occluder

Abstract

The present invention belongs to the technical field of medical devices and relates to a traction device for a degradable left atrial appendage occluder, comprising: a main body, a display unit for displaying a traction signal is arranged on the main body, a fixed component, the fixed component is slidably connected to the main body through a conversion component, and the conversion component is used to convert the movement signal of the fixed component into a display signal that can be displayed on the display unit; a delivery cable, one end of the delivery cable is connected to the fixed component, and the other end is connected to the left atrial appendage occluder; by slidingly connecting the fixed component with the main body, the external traction force of the degradable left atrial appendage occluder can be buffered, and the pulling force of the main body will not be directly applied to the delivery cable, thereby increasing the user's operating experience; at the same time, the traction force of the fixed component is converted into a visual signal through the conversion component, which is convenient for the operator to apply the traction force more intuitively, thereby reducing the risk of displacement and detachment of the occluder due to excessive traction force.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a pulling device for a degradable left atrial appendage occluder. Background Art

[0002] Left atrial appendage occlusion is to prevent the formation of thrombus in the left atrial appendage during atrial fibrillation by blocking the left atrial appendage, thereby reducing the risk of long-term disability or death in patients with atrial fibrillation due to thromboembolism. The commonly used occluder is the nickel-titanium alloy left atrial appendage occluder. With the innovative development of current materials, degradable left atrial appendage occluders are gradually being used. As for whether the left atrial appendage occluder is firmly hung in the atrial appendage, the operating habits of clinical operators need to pull the left atrial appendage occluder in vitro, and cooperate with imaging images to collect the deformation and displacement of the occluder to comprehensively judge the fixation of the left atrial appendage occluder. However, the degradable left atrial appendage occluder cannot be directly developed under radiation, and excessive pulling will affect the shape and position of the left atrial appendage occluder, thereby affecting the implantation effect and safety and stability.

[0003] Therefore, it is necessary to design a traction device for the degradable left atrial appendage occluder to quantitatively evaluate the traction effect through in vitro visualization and conduction of fixation force to help the surgeon determine whether the left atrial appendage is implanted stably. Summary of the invention

[0004] In view of this, the present invention provides a traction device for a left atrial appendage occluder. By arranging a conversion component on the traction device, the traction force of the delivery cable on the fixing device can be transmitted and converted into other displayable signals, and displayed through a display unit to facilitate in vitro visual observation of the traction of the delivery cable on the degradable left atrial appendage occluder, thereby judging whether the occluder is fixed.

[0005] The technical solution adopted by the present invention is:

[0006] A traction device for a left atrial appendage occluder comprises: a main body, on which is provided a display unit for displaying a traction signal, a fixing component, which is slidably connected to the main body via a conversion component, and the conversion component is used to convert a movement signal of the fixing component into a display signal that can be displayed on the display unit; and a conveying cable, one end of which is connected to the fixing component, and the other end of which is connected to the left atrial appendage occluder.

[0007] Further optimization of the technical solution of the present invention, the fixing assembly includes a locking nut and a movable shaft, the locking nut is connected to one end of the movable shaft by a thread, and a first limiting hole is provided at the center of the locking nut, and the first limiting hole is used for the conveying steel cable to pass through; the end of the movable shaft corresponding to the locking nut is provided with a locking mechanism for locking the conveying steel cable.

[0008] Further optimization of the technical solution of the present invention, the locking mechanism includes a locking silicone ring and a second limiting hole arranged at the end of the movable shaft, the locking silicone ring is arranged between the locking nut and the movable shaft, and an extrusion platform is arranged on the movable shaft; the conveying steel cable passes through the first limiting hole, the locking silicone ring and the second limiting hole in sequence.

[0009] Further optimization of the technical solution of the present invention, the locking mechanism is composed of the first conical limiting hole and a fixed tube arranged at one end of the movable shaft, and at least one through groove is arranged in the length direction of the side wall of the fixed tube, and the through groove makes the inner diameter of the fixed tube variable under the action of the first limiting hole, and the initial inner diameter of the fixed tube is larger than the diameter of the conveying steel cable, and the inner diameter of the fixed tube is smaller than the diameter of the conveying steel cable under the external force compression state; the inner diameter of the first limiting gradually decreases from large to small from close to one end of the movable shaft to the other end, and the maximum diameter is not less than the outer diameter of the fixed tube in the initial state.

[0010] Further optimization of the technical solution of the present invention is that a sliding plate is provided at one end of the movable shaft away from the locking nut, and a sliding groove corresponding to the sliding plate is provided on the main body, and a positioning display plate is provided on the sliding plate, and the positioning display plate corresponds to the display unit, and the display unit is a transparent panel marked with a prompt mark.

[0011] According to a further optimization of the technical solution of the present invention, the conversion component is a spring or a rubber band, a hook platform is provided at the free end of the sliding plate, one end of the spring or the rubber band is fixed to the hook platform, and the other end is fixed to the body.

[0012] According to a further optimization of the technical solution of the present invention, the display unit is a display screen, the conversion assembly includes a tension sensor, the tension sensor is respectively fixed on the moving shaft and the main body, and the tension sensor is electrically connected to the display screen through a controller.

[0013] In a further optimization of the technical solution of the present invention, an outer boss is provided on the outer side wall of the locking nut.

[0014] According to a further optimization of the technical solution of the present invention, the main body comprises a first shell and a second shell, and the first shell and the second shell are connected by snap-fitting or by screws.

[0015] According to a further optimization of the technical solution of the present invention, the outer walls of the first shell and the second shell are both provided with anti-slip structures.

[0016] Beneficial effects of the present invention:

[0017] By slidably connecting the fixing component with the main body, the external traction force of the degradable left atrial appendage occluder can be buffered, and the pulling force of the main body will not be directly applied to the delivery cable, thereby improving the user's operating experience; at the same time, the traction force of the fixing component is converted into a visual signal through the conversion component, which facilitates the operator to apply traction more intuitively and reduces the risk of displacement of the occluder due to excessive pulling force. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The above and other objects, features and advantages of the present invention will become more apparent through the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

[0019] Figure 1 It is a schematic diagram of the structure of the pulling device of the present invention in the application state;

[0020] Figure 2 It is a schematic diagram of the explosion structure of the pulling device of the present invention;

[0021] Figure 3 It is a structural schematic diagram of the locking nut of the present invention;

[0022] Figure 4 yes Figure 3 Schematic diagram of the cross-sectional structure along the middle line BB;

[0023] Figure 5 is a schematic diagram of the structure of a moving shaft in one embodiment of the present invention;

[0024] Figure 6 is a schematic structural diagram of the first shell of the present invention;

[0025] Figure 7 is a schematic structural diagram of the second shell of the present invention;

[0026] Figure 8 is a schematic diagram of a display unit structure in one embodiment of the present invention;

[0027] Fig. 9 It is a schematic diagram of the cross-sectional structure of a left atrial appendage occluder.

[0028] In the figure: 1. body; 2. moving shaft; 3. locking nut; 4. delivery cable; 5. left atrial appendage occluder; 6. left atrial appendage; 7. locking silicone ring; 8. spring; 9. transparent panel;

[0029] 11. First shell; 111. First slide groove; 112. First column; 113. First card slot; 12. Second shell; 121. Second slide groove; 122. Second column; 123. Second card slot; 21. Extrusion table; 22. Sliding plate; 23. Positioning display panel; 24. Hook table; 25. Second limiting hole; 31. First limiting hole; 32. Boss; 51. Inner plate; 52. Anchor hook; 53. Outer plate; 54. Locking ring; 91. Locking area; 92. Safety area; 93. Warning area. DETAILED DESCRIPTION

[0030] The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid confusing the essence of the present invention, known methods, processes, procedures, and components are not described in detail.

[0031] In addition, persons of ordinary skill in the art will appreciate that the drawings provided herein are for illustration purposes and are not necessarily drawn to scale.

[0032] Unless the context clearly requires otherwise, throughout the specification and claims, the words "include", "comprising" and similar words should be interpreted in an inclusive sense rather than an exclusive or exhaustive sense; that is, in the sense of "including but not limited to".

[0033] In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0034] Combined with the following Figure 1-9 The technical solution of this application is described in detail.

[0035] For the occluder provided by patent number 202210178730.5 in the prior art, it is necessary to judge its two working states when using it. One is to judge whether the anchor hook 52 is hung on the left atrial appendage 6; the other is to judge whether the inner plate and outer plate 53 structure are locked. The specific surgical operator judges whether it is fixed based on the resistance of traction. The traction force is generally 1-2N. If you are not careful, the occluder will be displaced or fall off due to excessive traction. In order to facilitate the understanding of the user of the traction device of this application, the structure of the occluder is briefly introduced as follows: Fig. 9As shown, the mesh stent is formed by weaving and shaping degradable silk material. The shaped skeleton is divided into an inner disk 51 and an outer disk 53, wherein the proximal end of the outer disk 53 is connected to a threaded rivet head, which is formed by thermoforming of degradable silk material, and the outer layer of the rivet head is a thread (connected to the delivery cable 4), and the middle is a through hole. The inner and outer disks 53 are sutured and fixed to the inner side of the skeleton by a degradable baffle body, and the inner disk is sutured with an anchor hook 52 for hanging on the left atrial appendage 6. The anchor hook 52 is formed by shaping of shape memory material. When the anchor hook 52 is connected to the left atrial appendage, the movement of the inner disk will be restricted, that is, it will not be displaced during traction. The inner and outer disks 53 are locked and fixed by a locking ring 54, wherein one end of the locking ring 54 close to the traction device is a deformable ring, which can pass through the inner hole of the threaded rivet head, and the other end of the locking ring 54 is fixed on the inner disk. After the locking ring 54 is locked, the inner disk 51 and the outer disk 53 fit together. After the outer disk 53 is pulled, if the outer disk 53 is deformed or moved, it is unlocked; if the outer disk 53 is unchanged, it is locked.

[0036] Therefore, in view of this technical problem, the technical solution of the present invention designs a pulling device for the left atrial appendage occluder 5, which reduces the difficulty of pulling through visual operation, and the use of the device is more convenient to judge whether the occluder is fixed. Specifically, the pulling device for the left atrial appendage occluder 5 includes: a body 1, a fixing component, a conversion component and a conveying cable 4, one end of the conveying cable 4 is connected to the body 1 through the fixing component and the conversion component, and the other end is connected to the rivet head of the left atrial appendage occluder 5. The operator applies external force to the body 1 to achieve the effect of pulling the conveying cable 4. The fixing component is slidably connected to the body 1 through the conversion component, and the conversion component is used to convert the movement signal of the fixing component into a display signal that can be displayed on the display unit. The display unit is arranged on the body 1 to facilitate direct display of the pulling signal.

[0037] In order to facilitate the fixation of the conveying steel cable 4, the fixing assembly includes a locking nut 3 and a movable shaft 2, the locking nut 3 is connected to one end of the movable shaft 2 by a thread, and a first limiting hole 31 is provided at the center of the locking nut 3, and the first limiting hole 31 is used for the conveying steel cable 4 to pass through; the end of the movable shaft 2 corresponding to the locking nut 3 is provided with a locking mechanism for locking the conveying steel cable 4. The locking mechanism includes a locking silicone ring 7 and a second limiting hole 25 arranged at the end of the movable shaft 2, the locking silicone ring 7 is arranged between the locking nut 3 and the movable shaft 2, and an extrusion platform 21 is arranged on the movable shaft 2; the conveying steel cable 4 passes through the first limiting hole 31, the locking silicone ring 7 and the second limiting hole 25 in sequence, and when fixing, the locking silicone ring 7 can be compressed by tightening the locking nut 3, so that the locking silicone ring 7 tightly holds the conveying steel cable 4 to achieve the purpose of fixing; in addition, by arranging an extrusion platform on the movable shaft 2, it is convenient to limit the locking silicone ring 7 to prevent the locking silicone ring 7 from entering the thread during the extrusion process.

[0038] With respect to the locking mechanism, another preferred technical solution is that it can be designed to consist of the first conical limiting hole 31 and a fixed tube arranged at one end of the movable shaft 2. Specifically, at least one through groove is arranged in the length direction of the side wall of the fixed tube (not shown in the figure), and the through groove extends from one end of the fixed tube close to the locking nut 3, with a length of 0.5-3 cm. The through groove makes the inner diameter of the fixed tube variable under the action of the first limiting hole 31. The through grooves are preferably 2-3, and all the through grooves are evenly distributed on the circumference of the fixed tube, and the initial inner diameter of the fixed tube is larger than the diameter of the conveying steel cable 4, and the inner diameter of the fixed tube is smaller than the diameter of the conveying steel cable 4 under external force compression. The diameter of the conveying steel cable 4 is such that when pressure is applied to the outer wall of the fixed tube, its inner wall can be in contact with the conveying steel cable 4, and as the external force increases, the purpose of clamping is achieved; the inner diameter of the first limiting hole 31 gradually decreases from one end close to the movable shaft 2 to the other end, and the maximum diameter is not less than the outer diameter of the fixed tube in the initial state, so that in the process of threading the locking nut 3 and the movable shaft 2, the fixed tube assembly will enter the first limiting hole 31, and as the locking nut 3 is displaced toward the direction of the movable shaft 2, the pressure exerted on the fixed tube by the inner wall of the first limiting hole 31 becomes greater, thereby compressing the gap of the through groove, reducing the diameter of the fixed tube, and locking and fixing the conveying steel cable 4.

[0039] On the basis of the above-mentioned embodiment, a sliding plate 22 is provided at one end of the movable shaft 2 away from the locking nut 3, and a slide groove corresponding to the sliding plate 22 is provided on the main body 1. Specifically, the main body 1 includes a first shell 11 and a second shell 12, and the middle parts of the first shell 11 and the second shell 12 are respectively provided with a first slide groove 111 and a second slide groove 121. The sliding plate 22 can slide freely in the two slide grooves. Preferably, ribs are provided on the left and right sides of the sliding plate 22 corresponding to the slide grooves, and the thickness of the ribs matches the width of the slide groove, so as to improve the stability of the slide plate during movement. A positioning display panel 23 is provided on the sliding plate 22. The positioning display panel 23 is located on the front of the sliding plate 22 and corresponds to the display unit. The display unit is a transparent panel 9 marked with a prompt mark. Specifically, Figure 8 As shown, the display panel is marked with a warning area 93, a safety area 92 and a locking area 91 (the locking area 91 is for the degradable left atrial appendage occluder 5 with a locking function, used to determine whether the degradable left atrial appendage occluder is locked; the safety area 92 is for the left atrial appendage occluder 5 anchor hook 52 hanging function, used to determine whether the degradable left atrial appendage occluder 5 is firmly hung on the left atrial appendage 6; the warning area is to prevent the operator from using too much force, resulting in the occluder being pulled out of the left atrial appendage 6), so that the user can control the traction force according to the position of the positioning display board 23 in the display panel during the pulling process, so that the front end of the positioning display board 23 is kept in the safe area (when judging whether the left atrial appendage occluder 5 is fixed, the positioning display board 23 is pulled within the range of the safety area 92, and when judging whether the left atrial appendage occluder 5 is locked, the positioning display board 23 is pulled within the range of the locking area 91). The transparent panel 9 is fixed by the first card slot 113 and the second card slot 123 respectively arranged on the first shell 11 and the second shell 12.

[0040] In the embodiment of the display unit made by the transparent panel 9, the conversion component is a spring 8 or a rubber band, and the free end of the sliding plate 22 is provided with a hook platform 24, one end of the spring 8 or the rubber band is fixed on the hook platform 24, and the other end is fixed on the body 1. Specifically, a fixing column is provided on the body 1, and the fixing column includes a first column 112 and a second column 122 respectively provided on the first shell 11 and the second shell 12. When in use, one end of the spring 8 or the rubber band is first set on one of the columns. When the first shell 11 and the second shell 12 are assembled together, the first column 112 and the second column 122 are docked to form a fixing column, and the spring 8 and the rubber band will not fall off. In this embodiment, the distal end of the delivery cable 4 is fixed to the rivet head of the degradable left atrial appendage occluder 5, and the proximal end is inserted into the first limiting hole 31 and the locking silicone ring of the locking nut 3, or inserted into the fixing tube of the locking nut 3 and the moving shaft 2, and the proximal end of the delivery cable 4 is fixed by screwing the locking nut and the screwing shaft of the moving shaft 2. By fixing one end of the spring 8 or rubber band of the conversion assembly on the hook platform 24 of the moving shaft 2 and the other end on the fixed column of the housing, the moving shaft 2 can move forward and backward in the slide groove of the first housing 11 and the second housing 12 under the connection of the sliding plate 22. When the body 1 is pulled outside the body, the moving shaft 2 will move relative to the opposite direction. Since the two are connected by the spring 8 or rubber band, the generated force will be transmitted to the left atrial appendage occluder 5 in the body through the delivery cable 4, and the left atrial appendage occluder 5 is hung on the atrial appendage wall. Therefore, the holding force of the left atrial appendage occluder 5 = the pulling force of the delivery cable 4 = the pulling force of the spring 8 = the pulling force of the hand outside the body. When judging whether the left atrial appendage occluder 5 is fixed, the pulling force range is generally 1-2N, and when judging whether the left atrial appendage occluder 5 is locked, the pulling force range is generally 0.3-1N. The main body 1 moves under the action of the pulling force, driving the display unit to move; the movement of the moving shaft 2 drives the movement of the positioning display board 23, so that the display panel of the display unit and the positioning display board 23 move in the opposite direction; thereby judging whether the relative displacement is in the safe zone 92, and then calculating the magnitude of the pulling force through the displacement and the spring 8 coefficient. Whether the occluder is firmly fixed can be judged by the conductivity of the force + the exceptional visualization area. Therefore, this method can control the pulling force used by the operator, and can accurately judge whether the anchor hook 52 of the left atrial appendage occluder 5 is firmly hung. The specific judgment method is to apply a traction force to the main body 1, and under the action of the spring, the moving shaft 2 is displaced. When the positioning display board 23 is used within the range of the safe zone 92, the inner disk 51 of the left atrial appendage occluder 5 is observed by pulling and angiography to see whether it is displaced. If there is no position change, it is judged to be fixed, and if there is a position change, it is not fixed.At the same time, when the left atrial appendage occluder 5 is locked, it can also be judged by the self-pulling force, and the pulling force of the main body 1 is controlled to make the positioning display panel 23 located within the range of the locking area 91. While pulling, it is observed with angiography whether the outer disk 53 of the left atrial appendage occluder 5 changes. If there is no position change, it means that the locking ring 54 has locked the left atrial appendage occluder 5. If there is a position change, it is not locked.

[0041] With respect to the display unit, an alternative technical solution is provided, in which the display unit is a display screen, and the conversion component includes a tension sensor, which can convert the collected tension into an electrical signal and display it on the display screen through a controller. The tension sensor is respectively fixed on the movable shaft 2 and the main body 1, and the tension sensor is electrically connected to the display screen through the controller. In this way, the digital display is more intuitive than that in the above-mentioned embodiment.

[0042] On the basis of the above embodiment, in order to facilitate the threaded connection between the locking nut 3 and the movable shaft 2, an outer boss 32 is provided on the outer wall of the locking nut 3, which is convenient for the user to directly screw it by hand, and is easy to use. Of course, the outer side of the locking nut 3 can also be provided with a frosted side or small bumps and other surfaces that can increase friction.

[0043] Preferably, the first shell 11 and the second shell 12 are connected by snap-fitting or by screws. When screws are used, the fixing column in the above embodiment can be used as a screw connection point, thereby achieving fixation between the first shell 11 and the second shell 12 and improving the integrity of the fixing column.

[0044] Preferably, the outer walls of the first shell 11 and the second shell 12 are both provided with anti-slip structures.

[0045] It should be understood that the above-mentioned embodiments are merely illustrative and not restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions that can be made by those skilled in the art to the above-mentioned details will all be included in the scope of the claims of the present invention.

Claims

1. A traction device for a degradable left atrial appendage occluder, characterized in that: include: A body, wherein a display unit for displaying a traction signal is provided on the body, wherein the display unit includes a warning area, a safety area, and a locking area. The locking area has a locking function for the left atrial appendage occluder and is used to determine whether the left atrial appendage occluder is locked; the safety area has a hanging function for the anchor hook of the left atrial appendage occluder and is used to determine whether the left atrial appendage occluder is firmly hung on the left atrial appendage; The warning area is to prevent the operator from using too much force, which may cause the left atrial appendage occluder to be pulled out of the left atrial appendage; A fixed component, the fixed component is slidably connected to the body through a conversion component, and the conversion component is used to convert a movement signal of the fixed component into a display signal that can be displayed on the display unit; The fixing assembly comprises a locking nut and a movable shaft, and one end of the movable shaft corresponding to the locking nut is provided with a locking mechanism for locking the conveying steel cable, and the locking mechanism comprises a locking silicone ring and a second limiting hole arranged at the end of the movable shaft, and the locking silicone ring is arranged between the locking nut and the movable shaft; a first limiting hole is arranged at the center of the locking nut, and the first limiting hole is used for the conveying steel cable to pass through; the conveying steel cable passes through the first limiting hole, the locking silicone ring and the second limiting hole in sequence; an extrusion platform is arranged on the movable shaft, and the extrusion platform is used to limit the locking silicone ring; One end of the delivery cable is connected to the movable shaft, and the other end is connected to the degradable left atrial appendage occluder.

2. The traction device for the degradable left atrial appendage occluder according to claim 1, characterized in that: The locking nut is connected to one end of the moving shaft via a thread.

3. The traction device for the degradable left atrial appendage occluder according to claim 2, characterized in that: The locking mechanism is composed of the first conical limiting hole and a fixed tube arranged at one end of the movable shaft, and at least one through groove is arranged in the length direction of the side wall of the fixed tube. The through groove makes the inner diameter of the fixed tube variable under the action of the first limiting hole, and the initial inner diameter of the fixed tube is larger than the diameter of the conveying steel cable, and the inner diameter of the fixed tube is smaller than the diameter of the conveying steel cable under the external force compression state; the inner diameter of the first limiting tube gradually decreases from one end close to the movable shaft to the other end, and the maximum diameter is not less than the outer diameter of the fixed tube in the initial state.

4. The traction device for the degradable left atrial appendage occluder according to any one of claims 2 to 3, characterized in that: A sliding plate is arranged at one end of the movable shaft away from the locking nut, and a sliding groove corresponding to the sliding plate is arranged on the main body, a positioning display plate is arranged on the sliding plate, and the positioning display plate corresponds to the display unit, and the display unit is a transparent panel.

5. The pulling device for the degradable left atrial appendage occluder according to claim 4, characterized in that: The conversion component is a spring or a rubber band, a hook platform is provided at the free end of the sliding plate, one end of the spring or the rubber band is fixed on the hook platform, and the other end is fixed on the body.

6. The traction device for the degradable left atrial appendage occluder according to any one of claims 2 to 3, characterized in that: The display unit is a display screen, and the conversion component includes a tension sensor, which is respectively fixed on the moving shaft and the body, and the tension sensor is electrically connected to the display screen through a controller.

7. The pulling device for the degradable left atrial appendage occluder according to claim 6, characterized in that: An outer boss is arranged on the outer side wall of the locking nut.

8. The traction device for the degradable left atrial appendage occluder according to any one of claims 1 to 3, characterized in that: The main body includes a first shell and a second shell, and the first shell and the second shell are connected by snap-fitting or by screws.

9. The pulling device for the degradable left atrial appendage occluder according to claim 8, characterized in that: The outer walls of the first shell and the second shell are both provided with anti-slip structures.

Images