Pulling device used for degradable left atrial appendage occluder

Abstract

The present invention relates to a pulling device used for a degradable left atrial appendage occlude. The pulling device comprises: a main body, the main body being provided with a display unit used for displaying a pulling signal; a fixing assembly, the fixing assembly being slidably connected to the main body by means of a conversion assembly, and the conversion assembly being used for converting a movement signal of the fixing assembly into a display signal that can be displayed on the display unit; and a delivery steel cable, one end of the delivery steel cable being connected to the fixing assembly, and the other end of same being connected to a left atrial appendage occluder. The fixing assembly is slidably connected to the main body, so that an external pulling force applied to the degradable left atrial appendage occluder can be buffered, and the pulling force of the main body does not directly act on the delivery steel cable, thereby improving the operation experience of users; moreover, the pulling force of the fixing assembly is converted into a visual signal by means of the conversion assembly, so that operators can apply pulling forces more visually, thereby reducing the risks of the displacement and detachment of occluders caused by excessively high pulling forces.

Description

[Amended according to Rule 26, 20.11.2025] A traction device for a biodegradable left atrial appendage occluder. Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a traction device for a biodegradable left atrial appendage occluder. Background Technology

[0002] Left atrial appendage occlusion (LAA) prevents thrombus formation in the left atrial appendage during atrial fibrillation (AF), thereby reducing the risk of long-term disability or death due to thromboembolism in AF patients. Currently, nickel-titanium alloy LAA occluders are commonly used. With advancements in materials science, biodegradable LAA occluders are increasingly being applied. Clinical practice often involves externally pulling on the occluder and using imaging to assess its deformation and displacement, thus determining its fixation. However, biodegradable LAA occluders are not directly visualized under X-ray, and excessive pulling can affect their shape and position, impacting implantation effectiveness and safety.

[0003] Therefore, it is necessary to design a traction device for a biodegradable left atrial appendage occluder, which can quantitatively assess the traction effect through in vitro visualization and the transmission of fixation force to help surgeons 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 setting a conversion component on the traction device, the traction force of the steel cable on the fixation device can be transmitted and converted into other displayable signals, which can be displayed through a display unit to facilitate in vitro visualization of the traction of the steel cable on the biodegradable left atrial appendage occluder, thereby determining whether the occluder is fixed.

[0005] The technical solution adopted in this invention is as follows:

[0006] A traction device for a left atrial appendage occluder includes: a body, on which a display unit for displaying traction signals is provided; a fixing component, which is slidably connected to the body via a conversion component, the conversion component being used to convert the movement signal of the fixing component into a display signal that can be displayed on the display unit; and a delivery 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] In a further optimization of the technical solution of the present invention, the fixing component includes a locking nut and a moving shaft. The locking nut is connected to one end of the moving shaft by a thread, and a first limiting hole is provided at the center of the locking nut for the conveying steel cable to pass through. A locking mechanism is provided at the end of the moving shaft corresponding to the locking nut for locking the conveying steel cable.

[0008] In a further optimization of the technical solution of the present invention, the locking mechanism includes a locking silicone ring and a second limiting hole disposed at the end of the moving shaft. The locking silicone ring is disposed between the locking nut and the moving shaft, and a pressing platform is disposed on the moving shaft. The conveying steel cable passes through the first limiting hole, the locking silicone ring and the second limiting hole in sequence.

[0009] In a further optimization of the technical solution of the present invention, the locking mechanism consists of a frustoconical first limiting hole and a fixed tube disposed at one end of the moving shaft. At least one through groove is provided in the length direction of the side wall of the fixed tube. The through groove allows the inner diameter of the fixed tube to be variable under the action of the first limiting hole. 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 external compression. The inner diameter of the first limiting hole gradually decreases from one end near the moving 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] In a further optimization of the technical solution of the present invention, a sliding plate is provided at the end of the moving shaft away from the locking nut, and a sliding groove corresponding to the sliding plate is provided on the body. A positioning display plate is provided on the sliding plate, and the positioning display plate corresponds to the display unit. The display unit is a transparent panel marked with prompts.

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

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

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

[0014] In a further optimization of the technical solution of the present invention, the main body includes a first housing and a second housing, wherein the first housing and the second housing are engaged or connected by screws.

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

[0016] The beneficial effects of this invention are:

[0017] By sliding the fixing component to the main body, the external traction force of the biodegradable left atrial appendage occluder can be buffered, preventing the tension of the main body from being directly applied to the delivery cable, thus improving the user's operating experience. At the same time, the conversion component transforms the traction force of the fixing component into a visual signal, making it easier for the operator to apply traction force more intuitively and reducing the risk of the occluder dislodging due to excessive traction force. Attached Figure Description

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

[0019] Figure 1 is a structural schematic diagram of the traction device of the present invention in application state;

[0020] Figure 2 is an exploded structural diagram of the traction device of the present invention;

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

[0022] Figure 4 is a schematic diagram of the cross-sectional structure along BB in Figure 3;

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

[0024] Figure 6 is a schematic diagram of the structure of the first housing of the present invention;

[0025] Figure 7 is a schematic diagram of the structure of the second housing of the present invention;

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

[0027] Figure 9 is a schematic cross-sectional view of the left atrial appendage occluder.

[0028] In the diagram: 1. Main body; 2. Moving shaft; 3. Locking nut; 4. Conveyor cable; 5. Left atrial appendage occluder; 6. Left atrial appendage; 7. Locking silicone ring; 8. Spring; 9. Transparent panel;

[0029] 11. First housing; 111. First slide groove; 112. First column; 113. First slot; 12. Second housing; 121. Second slide groove; 122. Second column; 123. Second slot; 21. Pressing table; 22. Sliding plate; 23. Positioning display plate; 24. Hook platform; 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 Implementation

[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, but well-known methods, processes, procedures, and elements are not described in detail in order to avoid obscuring the essence of the present invention.

[0031] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0032] Unless the context explicitly requires it, the words "comprising," "including," and similar terms throughout the specification and claims should be interpreted as encompassing rather than being exclusive or exhaustive; that is, meaning "including but not limited to."

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

[0034] The technical solution of this application will be described in detail below with reference to Figures 1-7.

[0035] Atrial fibrillation is a relatively common heart disease that causes blood to pool in the left atrial appendage (left atrial appendage 6), increasing the risk of blood clot formation. A left atrial appendage occluder (left atrial appendage occluder 5) can prevent blood clot formation and reduce the incidence of stroke by closing the left atrial appendage 6. It can also reduce blood flow velocity and pressure within the left atrial appendage 6, thereby reducing the burden on the heart and protecting heart health. Therefore, the left atrial appendage occluder 5 is widely used due to its good therapeutic effect. Furthermore, with technological advancements, biodegradable occluders have entered clinical practice and are gradually replacing traditional left atrial appendage occluders (left atrial appendage occluders 5). However, when using the biodegradable left atrial appendage occluder 5 in medical applications, due to its soft texture and inability to be visualized under X-ray, the surgeon typically uses a guidewire to pull the occluder 5 and judges its fixation based on the resistance. This operation requires a high level of skill from the surgeon, as the traction force is generally 1-2N. Slight carelessness can lead to displacement or dislodgement of the occluder due to excessive traction force. In particular, for the occluder provided by the existing patent number 202210178730.5, it is necessary to determine two working states during use: first, whether the rivet hook 52 is hooked on the left atrial appendage 6; and second, whether the inner and outer disc structures are locked. To facilitate understanding of the intended use of the traction device in this application, the structure of the occluder is described as follows: Its mesh support is made of biodegradable filaments woven and shaped (preferably PDO, PLA, or other biodegradable materials). The shaped skeleton consists of an inner disc 51 and an outer disc 53. The outer disc has a threaded rivet head near its proximal end, formed from biodegradable filaments using thermoforming. The outer layer of the rivet head is threaded (for connection to the conveying steel cable), and the center has a through hole. The inner and outer discs are fixed to the inner side of the skeleton by biodegradable fluid-resistant stitching. The inner disc is also stitched with an anchoring hook for attaching to the left atrial appendage 6. The anchoring hook 52 is made of shape memory material and, when connected to the left atrial appendage, restricts the movement of the inner disc, preventing displacement during traction. The inner and outer discs are locked together by a locking ring 54. One end of the locking ring 54 near the traction device is a deformable ring that can pass through the inner hole of the threaded rivet head. The other end of the locking ring 54 is fixed to the inner disc. After locking ring 52 is locked, inner disc 51 and outer disc 53 are in contact. If the outer disc deforms or moves after being pulled, it is not locked; if the outer disc does not change, it is locked.

[0036] Therefore, to address this technical problem, the present invention provides a traction device for a left atrial appendage occluder 5. This device reduces the difficulty of traction through visual operation and makes it easier to determine whether the occluder is fixed. Specifically, the traction device for the left atrial appendage occluder 5 includes: a body 1, a fixing component, a conversion component, and a transport cable 4. One end of the transport cable 4 is connected to the body 1 via 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 traction of the transport cable 4. The fixing component is slidably connected to the body 1 via the conversion component. The conversion component converts the movement signal of the fixing component into a display signal that can be displayed on a display unit. The display unit is located on the body 1 for easy direct display of the traction signal.

[0037] To facilitate the fixing of the conveying steel cable 4, the fixing assembly includes a locking nut 3 and a moving shaft 2. The locking nut 3 is connected to one end of the moving shaft 2 by a thread, and the locking nut 3 has a first limiting hole 31 at its center for the conveying steel cable 4 to pass through. The end of the moving 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 disposed at the end of the moving shaft 2. The locking silicone ring 7 is disposed between the locking nut 3 and the moving shaft 2, and a compression platform 21 is disposed on the moving 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. When fixing, tightening the locking nut 3 can compress the locking silicone ring 7, thereby making the locking silicone ring 7 tightly hold the conveying steel cable 4 to achieve the purpose of fixing. In addition, by providing a compression body on the moving shaft 2, it is convenient to limit the locking silicone ring 7 and prevent the locking silicone ring 7 from entering the thread during the compression process.

[0038] For the locking mechanism, another preferred technical solution is to design it as consisting of a frustoconical first limiting hole 31 and a fixed tube disposed at one end of the moving shaft 2. Specifically, at least one through groove (not shown in the figure) is provided along the length of the side wall of the fixed tube. The through groove extends from the end of the fixed tube near the locking nut 3 and has a length of 0.5-3 cm. The through groove allows the inner diameter of the fixed tube to be variable under the action of the first limiting hole 31. Preferably, there are 2-3 through grooves, and all through grooves are evenly distributed on the circumference of the fixed tube. 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 under external 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 contact the conveying steel cable 4, and with the increase of external force, the purpose of clamping is achieved; the inner diameter of the first limit gradually decreases from one end near the moving 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. In this way, during the process of screwing the locking nut 3 and the moving shaft 2, the fixed tube assembly will enter the first limit hole 31, and as the locking nut 3 moves towards the moving shaft 2, the pressure applied to the fixed tube by the inner wall of the first limit hole 31 will be greater, which will compress the gap of the through groove, reduce the diameter of the fixed tube, and clamp the conveying steel cable 4.

[0039] Based on the above implementation scheme, a sliding plate 22 is provided at the end of the moving shaft 2 away from the locking nut 3, and a sliding groove corresponding to the sliding plate 22 is provided on the body 1. Specifically, the body 1 includes a first housing 11 and a second housing 12, and the middle parts of the first housing 11 and the second housing 12 are respectively provided with a first sliding groove 111 and a second sliding groove 121. The sliding plate 22 can slide freely in the two sliding grooves. Preferably, the left and right sides of the sliding plate 22 corresponding to the sliding grooves are provided with protruding ribs, and the thickness of the protruding ribs matches the width of the sliding grooves, which can 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 prompts. Specifically, the display panel is marked with a warning zone 93, a safety zone 92, and a locking zone 91 (the locking zone 91 is for the biodegradable left atrial appendage occluder 5, which has a locking function and is used to determine whether the biodegradable occluder is locked; the safety zone 92 is for the anchor hook 52 of the left atrial appendage occluder 5, which is used to determine whether the biodegradable left atrial appendage occluder is locked). Whether the occluder 5 is securely attached to the left atrial appendage 6; the warning zone is to prevent the operator from using excessive force, causing the occluder to be 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 plate 23 in the display panel during the traction process, so that the front end of the positioning display plate 23 is kept in the safe area (when judging whether the left atrial appendage occluder 5 is fixed, the positioning display plate 23 is pulled within the safe area 92; when judging whether the left atrial appendage occluder 5 is locked, the positioning display plate 23 is pulled within the locking area 91). The transparent panel 9 is fixed by the first slot 113 and the second slot 123 respectively provided on the first housing 11 and the second housing 12.

[0040] In an embodiment where a display unit is made in conjunction with a transparent panel 9, the conversion component is a spring 8 or a rubber band. A hook platform 24 is provided at the free end of the sliding plate 22. One end of the spring 8 or the rubber band is fixed to the hook platform 24, and the other end is fixed to the body 1. Specifically, a fixing post is provided on the body 1. The fixing post includes a first post 112 and a second post 122 respectively provided on the first housing 11 and the second housing 12. In use, one end of the spring 8 or the rubber band is first placed on one of the posts. When the first housing 11 and the second housing 12 are assembled together, the first post 112 and the second post 122 are joined together to form a fixing post, preventing the spring 8 and the rubber band from falling off. In this embodiment, the distal end of the delivery cable 4 is fixed with the rivet head of the biodegradable 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 into the fixing tube of the locking nut 3 and the moving shaft 2. The proximal end of the delivery cable 4 is fixed by tightening the locking nut and the tightening shaft of the moving shaft 2. By fixing one end of the spring 8 or rubber band of the conversion component to the hook platform 24 of the moving shaft 2 and the other end to the fixed post of the housing, the moving shaft 2 can move back and forth in the sliding 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 externally, the moving shaft 2 will move in the opposite direction. Since the two are connected by the spring 8 or rubber band, the force generated will be transmitted to the left atrial appendage occluder 5 in the body through the delivery steel cable 4. The left atrial appendage occluder 5 is hung on the wall of the atrial appendage. Therefore, the holding force of the left atrial appendage occluder 5 = the tension of the delivery steel cable 4 = the pulling force of the spring 8 = the pulling force of the external hand. When judging whether the left atrial appendage occluder 5 is fixed, the pulling force range is generally 1-2N. 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 tension, causing the display unit to move; the movement of the moving shaft 2 causes the positioning display plate 23 to move, resulting in the display panel of the display unit and the positioning display plate 23 moving in opposite directions; thus, it is determined whether the relative displacement is within the safe zone 92, and the magnitude of the traction force is calculated by the displacement and the spring coefficient 8. The occluder's fixation can be determined by the force transmission and the exceptional visualization area. Therefore, this method allows control of the pulling force used by the operator and accurate determination of whether the anchor hook 52 of the left atrial appendage occluder 5 is securely attached. Specifically, a traction force is applied to the main body; under the action of the spring, the moving shaft displaces. When the positioning display plate 23 is within the safe zone 92, traction is combined with angiography to observe whether the inner disc 51 of the left atrial appendage occluder 5 has displaced. If no position change occurs, it is determined to be fixed; if a position change occurs, it is not fixed.Meanwhile, once the left atrial appendage occluder 5 is locked, it can also be judged by its own traction force, and the traction force of the main body 1 can be controlled to make the positioning display plate 23 located within the locking area 91. While traction is being performed, angiography can be used to observe whether there is any change in the outer disk 53 of the left atrial appendage occluder 5. If there is no change in position, it means that the locking ring 54 has locked the left atrial appendage occluder 5. If there is a change in position, it means that it is not locked.

[0041] For the display unit, an alternative technical solution is that 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 fixed on the moving shaft 2 and the body 1 respectively, and the tension sensor is electrically connected to the display screen through the controller. In this way, the digital display is more intuitive than the above embodiment.

[0042] Based on the above embodiments, in order to facilitate the threaded connection between the locking nut 3 and the moving shaft 2, an outer boss 32 is provided on the outer side wall of the locking nut 3, which makes it convenient for the user to directly handle 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 protrusions or other surfaces that can increase friction.

[0043] Preferably, the first housing 11 and the second housing 12 are engaged or connected by screws. When screws are used, the fixing post in the above embodiment can serve as a screw connection point, thus achieving fixation between the first housing 11 and the second housing 12 and improving the integrity of the fixing post.

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

[0045] It should be understood that the above embodiments are merely exemplary and not restrictive. Various obvious or equivalent modifications or substitutions that can be made by those skilled in the art regarding the above details without departing from the basic principles of the present invention will be included within the scope of the claims of the present invention.

Claims

1. A traction device for a biodegradable left atrial appendage occluder, characterized in that, include: The main body, on which a display unit is provided for displaying traction signals, A fixed component is slidably connected to the body via a conversion component, the conversion component being 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 which is connected to the fixing component, and the other end of which is connected to a biodegradable left atrial appendage occluder.

2. The traction device for the biodegradable left atrial appendage occluder according to claim 1, characterized in that, The fixing component 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 in the center of the locking nut 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.

3. The traction device for the biodegradable left atrial appendage occluder according to claim 2, characterized in that, The locking mechanism includes a locking silicone ring and a second limiting hole disposed at the end of the moving shaft. The locking silicone ring is disposed between the locking nut and the moving shaft. The conveying steel cable passes through the first limiting hole, the locking silicone ring and the second limiting hole in sequence.

4. The traction device of the biodegradable left atrial appendage occluder according to claim 2, characterized in that, The locking mechanism consists of a frustoconical first limiting hole and a fixed tube disposed at one end of the moving shaft. At least one through groove is provided along the length of the side wall of the fixed tube. The through groove allows the inner diameter of the fixed tube to be variable under the action of the first limiting hole. 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 external compression. The inner diameter of the first limiting hole gradually decreases from one end near the moving shaft to the other end, and the maximum diameter is not less than the outer diameter of the fixed tube in its initial state.

5. The traction device for the biodegradable left atrial appendage occluder according to any one of claims 2-4, characterized in that, A sliding plate is provided at the 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. A positioning display plate is provided on the sliding plate, and the positioning display plate corresponds to the display unit, which is a transparent panel.

6. The traction device for the biodegradable left atrial appendage occluder according to claim 5, characterized in that, The conversion component is a spring or a rubber band. The free end of the sliding plate is provided with a hook platform. One end of the spring or the rubber band is fixed on the hook platform, and the other end is fixed on the main body.

7. The traction device for the biodegradable left atrial appendage occluder according to any one of claims 2-4, characterized in that, The display unit is a display screen, and the conversion component includes a tension sensor. The tension sensor is fixed on the moving shaft and the main body respectively, and the tension sensor is electrically connected to the display screen through a controller.

8. The traction device for the biodegradable left atrial appendage occluder according to claim 7, characterized in that, An external boss is provided on the outer side wall of the locking nut.

9. The traction device of the left atrial appendage occlusion device according to claims 1-4, 6 or 8, characterized in that, The main body includes a first housing and a second housing, which are engaged or connected by screws.

10. The traction device for the biodegradable left atrial appendage occluder according to claim 6, characterized in that, The outer walls of both the first and second housings are provided with anti-slip structures, and the display unit includes a warning zone, a safety zone, and a locking zone.

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