A left atrial appendage occluder end structure and a left atrial appendage occluder
By setting staggered locking parts and a three-layer ring assembly structure at the end of the left atrial appendage occluder support rod, the problems of uneven closing and difficult conveying are solved, improving the stability and flexibility of the occluder and meeting the needs of small-diameter conveying.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- TAIZHOU INST OF BIOMEDICAL & MEDICAL DEVICES SOUTHEAST UNIV
- Filing Date
- 2023-07-24
- Publication Date
- 2026-05-29
AI Technical Summary
Existing left atrial appendage occlusion devices have difficulty ensuring uniformity during the closing process, leading to problems such as poor mechanical performance, incomplete occlusion, and blood leakage. At the same time, the size of the closing tooling limits the feasibility of delivery.
The support rod is equipped with a snap-fit part at the end, which is staggered along the axis of the support rod. Combined with the three-layer ring structure of the assembly part, the positioning and fixing of the support rod and the uniformity of the closing are achieved through the cooperation of the snap-fit groove and the assembly groove, thereby reducing the outer diameter of the closing tool.
This approach achieves a balance between uniformity of the left atrial appendage occluder's inlet and small-diameter delivery, improving the stability and flexibility of the occluder and reducing delivery resistance and the risk of injury to the patient.
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Figure CN116763387B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of left atrial appendage occlusion device technology, specifically to a left atrial appendage occlusion device end structure and a left atrial appendage occlusion device. Background Technology
[0002] After heat treatment and shaping, the left atrial appendage occluder requires welding to close the ends of the support rods for later addition of a covering layer and assembly. However, due to the complex structure and small size of the left atrial appendage occluder, and the large number of support rods, it is difficult to uniformly close the ends. Furthermore, the uniformity of the closing cannot be guaranteed. Poor closing of the left atrial appendage occluder can lead to several problems. First, poor closing may affect the mechanical properties of the occluder, such as wear resistance, tensile strength, and bending performance, potentially impacting its stability and durability. Second, poor closing may result in incomplete occlusion, causing blood leakage from the closing point, leading to complications such as bleeding and arrhythmia. Furthermore, poor closing can cause air bubbles to form inside the occluder, affecting its occlusion effect and even leading to serious complications such as thrombosis and cerebral embolism. Finally, poor closing can also lead to other complications. Therefore, the quality of the closing is particularly important for left atrial appendage occluders.
[0003] The existing left atrial appendage occluder uses a constriction fixture to tighten the end of the device. The support rod is fixed by snapping the end of the constriction fixture into the device. The fixing and arrangement of the support rod determines the size of the constriction fixture. Before the occluder is released, the support rod can retract, but the size of the constriction fixture remains unchanged. Therefore, the diameter of the delivery tube is limited by the size of the constriction fixture, which leads to the problem that the delivery cannot be smoothly carried out in actual operation because the outer diameter of the fixture is too large. Summary of the Invention
[0004] Technical objective: To address the shortcomings of existing occluders whose dimensions are affected by the size of the closing tooling, making them unable to meet the needs of some small-diameter delivery and release, this invention discloses a left atrial appendage occluder structure and occluder that can effectively reduce the outer diameter of the closing tooling after closing, while ensuring the uniformity of closing.
[0005] Technical solution: To achieve the above technical objectives, the present invention adopts the following technical solution:
[0006] A left atrial appendage occluder end structure includes a support rod. The end of the support rod is provided with a snap-fit part for positioning and fixing the support rod in conjunction with the closing structure of the occluder. The snap-fit part is arranged in a direction perpendicular to the rod body, and the snap-fit parts on adjacent support rods are staggered from each other along the axial direction of the support rod.
[0007] Preferably, the snap-fit portion of the present invention is divided into a first snap-fit portion and a second snap-fit portion according to its distribution position on the support rod. The first snap-fit portion is located at the end of the support rod and extends from the side of the end of the support rod to both sides in a direction perpendicular to the rod body. The second snap-fit portion is staggered from the first snap-fit portion and extends from the rod body to both sides in a direction perpendicular to the rod body.
[0008] Preferably, the extension portions of the first and second snap-fit portions of the present invention are symmetrically distributed relative to the corresponding support rods, so that the ends of the support rods form corresponding T-shaped and cross-shaped shapes.
[0009] The present invention also discloses a left atrial appendage occluder, using the above-mentioned end structure of a left atrial appendage occluder, including a fixing part and an assembly part for connecting with a support rod to form an occluder. One end of the support rod is fixedly connected to the fixing part, and the other end is detachably connected to the assembly part. The support rods are evenly arranged along the circumferential direction of the fixing part, and a snap-fit part is provided at one end of the support rod near the assembly part. The assembly part is provided with a snap-fit groove corresponding to the shape of the end of the support rod.
[0010] Preferably, the first and second snap-fit portions of the snap-fit portion of the present invention are both located in the area where the assembly portion is located; the assembly portion is provided with a first snap-fit groove for cooperating with the first snap-fit portion and a second snap-fit groove for cooperating with the second snap-fit portion.
[0011] Preferably, the assembly part of the present invention is located inside the mesh structure formed by the support rod, and the support rod is bent from the outside of the assembly part and connected to the assembly part to form a concave sealing device structure.
[0012] Preferably, the assembly part of the present invention includes an attachment layer short connector, an embedding layer short connector, and a cover layer short connector arranged concentrically from the inside out. Assembly holes are correspondingly provided through the attachment layer short connector, the embedding layer short connector, and the cover layer short connector. A fixing rod inserted into the assembly hole secures the assembly part as a whole. A snap-fit groove is provided on the embedding layer short connector, the thickness of which is consistent with the support rod. One end of the support rod with the snap-fit part is confined within the snap-fit groove. The surface of the support rod is flush with the outer surface of the embedding layer short connector. The cover layer short connector is located on the outer ring of the embedding layer short connector, limiting the position of the snap-fitted support rod. The cover layer short connector has an assembly groove that matches the shape of the end of the support rod. The support rod enters the corresponding snap-fit groove through the assembly groove, and the snap-fit groove is switched by rotating the cover layer short connector.
[0013] Preferably, the assembly groove of the present invention has slots corresponding to the first and second snap-fit portions of the support rod. When the short connector of the cover layer rotates to the corresponding snap-fit slot position, the end of the support rod enters the snap-fit slot from the assembly groove.
[0014] Beneficial effects: The left atrial appendage occluder structure and left atrial appendage occluder provided by the present invention have the following beneficial effects:
[0015] 1. The support rod of the left atrial appendage occluder of the present invention is provided with a snap-fit part. The snap-fit parts of adjacent support rods are staggered along the axial direction of the support rod, which reduces the space occupied by the snap-fit part, thereby reducing the diameter of the assembly part. This achieves the purpose of reducing the overall size of the occluder in the contracted state, so that it can meet the size requirements of small-diameter delivery pipes and improve the application performance of the left atrial appendage occluder.
[0016] 2. The snap-fit part of the present invention consists of a first snap-fit part and a second snap-fit part, both of which extend along the support rod in a direction perpendicular to the support rod body. This ensures sufficient axial fixing strength for the support rod, while maintaining a uniform overall length for the support rod. By engaging the snap-fit part with the corresponding snap-fit groove, the uniformity of the sealing device's closing after assembly is improved, ensuring the closing quality.
[0017] 3. The assembly part of the left atrial appendage occluder of the present invention is located inside the mesh area formed by the support rod, forming an end-concave occluder structure, which can further reduce the volume of the occluder, reduce delivery resistance, and also avoid damage to the treatment subject caused by the structure of the assembly part after the occluder is released.
[0018] 4. The assembly part of the present invention uses a concentric three-layer ring structure to snap and fix the end of the support rod, accurately positioning and restricting the support rod in the snap-fit groove. By first bending the support rod inward and then snapping it in the snap-fit groove, the support rod of the plug has a certain degree of axial deformation capability, thereby improving the flexibility of the plug.
[0019] 5. The short connector of the cover layer of the present invention is provided with an assembly groove. By rotating the short connector of the cover layer, the assembly groove is aligned with the snap-fit groove. After the end of the current support rod is fixed, the end connector of the cover layer is rotated again, so that when other support rods are fixed, the position of the support rod that has been fixed and snapped remains unchanged, thereby reducing the assembly difficulty and improving the uniformity of the assembled end section. Attached Figure Description
[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below.
[0021] Figure 1 This is a schematic diagram of the end structure of the left atrial appendage occluder of the present invention;
[0022] Figure 2 Overall structural diagram of the left atrial appendage occluder assembly of the present invention;
[0023] Figure 3 This is a structural diagram of the attachment layer short connector of the present invention;
[0024] Figure 4 This is a structural diagram of the embedded layer short connector of the present invention;
[0025] Figure 5 This is a structural diagram of the short connector for the cover layer of the present invention;
[0026] Figure 6 This is a partially enlarged view of the assembly part of the present invention;
[0027] Figure 7 This is a structural diagram of the attachment layer positioning tube of the present invention;
[0028] Figure 8 This is a structural diagram of the embedded layer positioning tube of the present invention;
[0029] Figure 9 This is a structural diagram of the cover layer positioning tube of the present invention;
[0030] Figure 10 This is a structural diagram of the positioning block of the present invention;
[0031] Among them, 1-support rod, 2-fixing part, 3-assembly part, 4-clamping part, 5-clamping groove, 6-attachment layer short connector, 7-embedded layer short connector, 8-covering layer short connector, 9-assembly hole, 10-fixing rod, 11-assembly groove, 12-core rod, 13-attachment layer positioning tube, 14-embedded layer positioning tube, 15-covering layer positioning tube, 16-proximal fixator, 17-covering layer long tube, 18-covering layer short tube, 19-covering layer mounting groove, 20-distal fixator, 21-positioning block, 22-second clamping groove, 23-positioning groove, 24-limiting rod, 25-first clamping part, 26-second clamping part, 27-first clamping groove. Implementation
[0032] The present invention will now be described more clearly and completely by way of a preferred embodiment in conjunction with the accompanying drawings, but this does not limit the invention to the scope of the described embodiment.
[0033] like Figures 1-6 As shown, the end structure of a left atrial appendage occluder disclosed in this invention includes a support rod 1. The end of the support rod 1 is provided with a snap-fit part 4 for positioning and fixing the support rod 1 in conjunction with the closing structure of the occluder. The snap-fit part 4 is arranged in a direction perpendicular to the rod body of the support rod 1, and the snap-fit parts 4 on adjacent support rods 1 are staggered from each other in the axial direction of the support rod 1.
[0034] Specifically, the snap-fit portion 4 of the present invention is divided into a first snap-fit portion 25 and a second snap-fit portion 26 according to its distribution position on the support rod 1. The first snap-fit portion 25 is located at the end of the support rod 1 and extends from the side of the end of the support rod 1 to both sides. The second snap-fit portion 26 is staggered from the first snap-fit portion 25 and extends from the rod body of the support rod 1 to both sides.
[0035] By using staggered first and second snap-fit parts, and corresponding snap-fit grooves to snap-fit and fix the end of the support rod 1, the space occupied by the snap-fit parts can be reduced while ensuring the uniformity of the position of each support rod. This allows the size of the assembly part to be reduced while ensuring sufficient structural strength, so that the left atrial appendage occluder can meet the size requirements of small-diameter delivery catheters and improve the application performance of the product.
[0036] The structural shapes of the first snap-fit part 25 and the second snap-fit part 26 can be selected according to the specifications of the actual plugging device. While ensuring sufficient connection strength, the first snap-fit part 25 is set separately on one side of the support rod 1, thereby minimizing the diameter required for the closing of the plugging device and reducing the size to meet the size requirements under different usage conditions. To ensure the uniformity of force on the support rod 1, preferably, the extension portions of the first snap-fit part 25 and the second snap-fit part 26 of the present invention are symmetrically distributed relative to the corresponding support rod 1, so that the ends of the support rod 1 form corresponding T-shaped and cross-shaped shapes.
[0037] The present invention also discloses a left atrial appendage occluder, which uses the above-mentioned end structure of the left atrial appendage occluder, including a fixing part 2 and an assembly part 3 for connecting with a support rod 1 to form an occluder. One end of the support rod 1 is fixedly connected to the fixing part 2, and the other end is detachably connected to the assembly part 3. The support rods 1 are evenly arranged along the circumferential direction of the fixing part 1. A snap-fit part 4 is provided at the end of the support rod 1 near the assembly part 3. The assembly part 3 is provided with a snap-fit groove 5 corresponding to the shape of the end of the support rod 1.
[0038] The first snap-fit portion 25 and the second snap-fit portion 26 of the snap-fit portion 4 of the present invention are both located in the area where the assembly portion 3 is located; the assembly portion 3 is provided with a first snap-fit groove 27 for cooperating with the first snap-fit portion 25 and a second snap-fit groove 22 for cooperating with the second snap-fit portion 26.
[0039] The assembly part 3 of the present invention is located inside the mesh structure formed by the support rod 1. The support rod 1 bends from the outside of the assembly part 3 and connects to the assembly part 3 to form a concave occluder structure. This can further reduce the volume of the occluder, reduce the delivery resistance, and also prevent the structure of the assembly part from causing damage to the treatment subject after the occluder is released. It can also shorten the length of the occluder and at the same time enable the occluder support rod to have a certain degree of axial deformation capability, thereby improving the flexibility of the occluder.
[0040] The following is a specific assembly part 3 structure provided by the present invention, including an attachment layer short connector 6, an embedding layer short connector 7, and a cover layer short connector 8 arranged concentrically from the inside out. The attachment layer short connector 6, the embedding layer short connector 7, and the cover layer short connector 8 are respectively provided with assembly holes 9. The assembly part 3 is fixed as a whole by a fixing rod 10 passing through the assembly hole 9. A snap-fit groove 5 is provided on the embedding layer short connector 7. The thickness of the embedding layer short connector 7 is the same as that of the support rod 1. One end of the support rod 1 with a snap-fit part 4 is restricted in the snap-fit groove 5. The surface of the support rod 1 is flush with the outer surface of the embedding layer short connector 7. The cover layer short connector 8 is located on the outer ring of the embedding layer short connector 7 and limits the position of the support rod 1 after snap-fit. The cover layer short connector 8 is provided with an assembly groove 11 that matches the shape of the end of the support rod 1. The support rod 1 enters the corresponding snap-fit groove 5 through the assembly groove 11. The snap-fit groove 5 is switched by rotating the cover layer short connector 8.
[0041] To facilitate switching of the connected snap-fit slot positions and ensure the positioning and fixation of the already snap-fit support rod, thus guaranteeing the final closing quality, the assembly slot 11 of the present invention has slots corresponding to the first snap-fit portion and the second snap-fit portion of the support rod 1. When the cover layer short connector 8 rotates to the corresponding snap-fit slot 5 position, the end of the support rod 1 enters the snap-fit slot 5 from the assembly slot 11.
[0042] like Figures 7-10 As shown, the present invention also provides a left atrial appendage occluder closing device for closing the aforementioned left atrial appendage occluder. The device includes a mandrel 12 and an attachment layer positioning tube 13, an embedding layer positioning tube 14, and a covering layer positioning tube 15 sequentially arranged around the mandrel 12. All are made of medical-grade 316L material. The attachment layer positioning tube 13, the embedding layer positioning tube 14, and the covering layer positioning tube 15 each have a two-section structure. The attachment layer positioning tube 13 and the embedding layer positioning tube 14 are axially fixed to their corresponding short connectors via a concave-convex positioning structure. The fixing part 2 of the left atrial appendage occluder is sleeved around the outer periphery of the covering layer positioning tube 15. The common end of the core rod 12, the attachment layer positioning tube 13, the embedded layer positioning tube 14, and the cover layer positioning tube 15 is positioned and fixed by the proximal end retainer 16. One end of the cover layer positioning tube 15 near the proximal end retainer 16 is the cover layer long tube 17, and the other end is the cover layer short tube 18. The cover layer long tube 17 and the cover layer short connector 8 are axially positioned and fixed by a concave-convex positioning structure. The cover layer short tube 18 has a cover layer mounting groove 19 at one end near the cover layer short connector 8, which corresponds to the snap-fit groove 5 on the embedded layer short connector 7. The cover layer mounting groove 19 provides installation space for the bent part of the support rod 1.
[0043] In this invention, the attachment layer positioning tube 13, the embedded layer positioning tube 14, and the cover layer short tube 18 are positioned and fixed at their ends away from the proximal fixator 16 by the distal fixator 20. The distal fixator 20 includes a positioning block 21 and a positioning bolt. The core rod 12 passes through the positioning block 21. The positioning block 21 is provided with a positioning groove 23 at its end near the cover layer short tube 18. The positioning groove 23 includes a central hole located in the center and rectangular positioning holes around the central hole. The width of the rectangular positioning holes is between the diameter of the embedded layer positioning tube 14 and the diameter of the cover layer positioning tube 15. The ends of the attachment layer positioning tube 13 and the embedded layer positioning tube 14 are provided with limiting rods 24. The limiting rods 24 pass through the positioning groove 23 to restrict the rotation of the two positioning tubes. The positioning block 21 and the core rod 12 are fixed together by the positioning bolt.
[0044] When using the occluder closing fixture of the present invention, the mandrel 12, the attachment layer positioning tube 13, the embedding layer positioning tube 14, the cover layer positioning tube 15, and the corresponding short connectors are assembled in sequence. The ends of each positioning tube are positioned by the proximal fixator 16. Then, the fixing part of the left atrial appendage occluder is sleeved on the cover layer long tube 17. The positioning block 21 is inserted from the end of the mandrel 12 to limit the ends of each positioning tube. The cover layer long tube 17 drives the embedding layer short connector 7 to rotate, so that the assembly groove 11 corresponds to the snap-fit groove 5. Then, the end of the corresponding support rod is inserted into the snap-fit groove 5 along the assembly groove 11. The bent part of the support rod is located in the cover layer mounting groove 19. Then continue to rotate the cover layer tube 17 to rotate the assembly slot 11 to the position of the next snap-fit slot 15, while restricting the already snapped support rod 1 within the embedded short connector 7. In order to avoid the assembly slot 11 repeatedly passing through the already snapped snap-fit slot, when actually assembling the left atrial appendage occluder, take the corresponding position of each assembly hole as the starting point and rotate the cover layer tube 17 in a single direction to snap and fix the end of the support rod 1 in sequence until the assembly holes overlap again. Insert the fixing rod to complete the fixation between the short connectors. Finally, remove the fixing device and positioning tube and other components in sequence according to the assembly order to obtain the finished left atrial appendage occluder product.
[0045] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.
Claims
1. A left atrial appendage occlusion device end structure, characterized in that, Includes a support rod (1), the end of which is provided with a snap-fit part (4) for positioning and fixing the support rod (1) in conjunction with the closing structure of the plug. The snap-fit part (4) is arranged in a direction perpendicular to the rod body of the support rod (1), and the snap-fit parts (4) on adjacent support rods (1) are staggered from each other in the axial direction of the support rod (1). The latching part (4) is divided into a first latching part (25) and a second latching part (26) according to its distribution position on the support rod (1). The first latching part (25) is located at the end of the support rod (1) and extends from the side of the end of the support rod (1) to both sides along the direction perpendicular to the rod body of the support rod (1). The second latching part (26) is staggered from the first latching part (25) and extends from the rod body of the support rod (1) to both sides along the direction perpendicular to the rod body of the support rod (1). The extension portions of the first snap-fit part (25) and the second snap-fit part (26) are symmetrically distributed relative to the corresponding support rod (1), so that the ends of the support rod (1) form corresponding T-shaped and cross-shaped shapes; The support rod (1) bends from the outside of the assembly part of the plug and connects to the assembly part to form a concave structure.
2. A left atrial appendage occlusion device, using the end structure of the left atrial appendage occlusion device according to claim 1, characterized in that, It includes a fixing part (2) and an assembly part (3) for connecting with the support rod (1) to form a left atrial appendage occluder. One end of the support rod (1) is fixedly connected to the fixing part (2), and the other end is detachably connected to the assembly part (3). The support rod (1) is evenly arranged along the circumferential direction of the fixing part (2). The snap-fit part (4) is provided at the end of the support rod (1) near the assembly part (3). The assembly part (3) is provided with a snap-fit groove (5) corresponding to the shape of the end of the support rod (1).
3. A left atrial appendage occlusion device according to claim 2, characterized in that, The first snap-fit portion (25) and the second snap-fit portion (26) of the snap-fit portion (4) are both located in the area of the assembly portion (3); the assembly portion (3) is provided with a first snap-fit groove (27) for cooperating with the first snap-fit portion (25) and a second snap-fit groove (22) for cooperating with the second snap-fit portion (26).
4. A left atrial appendage occlusion device according to claim 3, characterized in that, The assembly part (3) is located inside the mesh structure formed by the support rod (1). The support rod (1) bends from the outside of the assembly part (3) and connects to the assembly part (3) to form a concave plug structure.
5. A left atrial appendage occlusion device according to claim 3, characterized in that, The assembly part (3) includes a short connector for the attachment layer (6), a short connector for the embedding layer (7), and a short connector for the cover layer (8) arranged concentrically from the inside out. Assembly holes (9) are provided through the short connectors for the attachment layer (6), the embedding layer (7), and the cover layer (8). The assembly part (3) is fixed as a whole by a fixing rod (10) inserted into the assembly hole (9). A snap-fit groove (5) is provided on the short connector for the embedding layer (7). The thickness of the short connector for the embedding layer (7) is consistent with that of the support rod (1). The support rod (1) is provided with... One end of the snap-fit part (4) is restricted in the snap-fit groove (5). The surface of the support rod (1) is flush with the outer surface of the embedded layer short connector (7). The cover layer short connector (8) is located on the outer ring of the embedded layer short connector (7) to limit the support rod (1) after snap-fit. The cover layer short connector (8) is provided with an assembly groove (11) that matches the shape of the end of the support rod (1). The support rod (1) enters the corresponding snap-fit groove (5) through the assembly groove (11). The snap-fit groove (5) is switched by rotating the cover layer short connector (8).
6. A left atrial appendage occlusion device according to claim 5, characterized in that, The assembly groove (11) has slots corresponding to the first snap-fit portion (25) and the second snap-fit portion (26) of the support rod (1). When the cover short connector (8) rotates to the corresponding snap-fit groove (5) position, the end of the support rod (1) enters the snap-fit groove (5) from the assembly groove (11).