A highly adaptable left atrial appendage occluder

Abstract

This invention discloses a highly adaptable left atrial appendage occluder, relating to the field of medical device technology. The key technical features are: a proximal external pin with an internal cavity is provided at the center of the proximal end of the occluder; a proximal internal internal pin with an internal cavity is fixedly installed inside the proximal external pin; the inner wall of the proximal internal pin has threads for adjustment and limiting; a threaded disc is inserted into the internal thread of the proximal internal pin; a sleeve is fixedly connected to the surface of the threaded disc; a rotating sleeve is rotatably connected to the outer side of the sleeve via a bearing; and a guide is provided inside the sleeve. The snap-fit ​​structure at the top of the sheath allows for the connection of a threaded disc and a sleeve via an internal thread on the proximal inner pin. A rotating sleeve is connected to the outside of the sleeve via a bearing. Deformation strips and bending strips are used on the outside of the rotating sleeve to connect the support rod and the occluder bracket. The snap-fit ​​structure, in conjunction with the delivery system, allows the threaded disc to slide within the proximal inner pin. Under the constraint of the limiting structure, the support rod drives the occluder bracket to unfold. This allows for the limitation of the unfolding range of the occluder bracket, making it more adaptable to occlusion of left atrial appendages of different sizes.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a highly adaptable left atrial appendage occlusion device. Background Technology

[0002] Atrial fibrillation (AF) is one of the most common cardiac arrhythmias. The greatest risk of AF lies in its potential to cause embolic events, such as acute cerebral infarction and acute myocardial infarction. High-risk AF patients require aggressive anticoagulation therapy. However, drug anticoagulation carries the risk of bleeding, including cerebral hemorrhage. Left atrial appendage occlusion (LAA) is an interventional procedure that uses a domestic or imported occluder to block the left atrial appendage (LAA) and prevent thrombus formation during AF. This achieves the therapeutic effect of drug anticoagulation, reducing the risk of long-term disability or death from thromboembolism in AF patients, while significantly lowering the risk of bleeding. Therefore, LAA occlusion can eliminate patients' dependence on long-term oral anticoagulation therapy, providing a new treatment option for patients who cannot receive long-term anticoagulation therapy, are unwilling to undergo drug anticoagulation therapy, or are at high risk of bleeding.

[0003] Currently, most commercially available left atrial appendage occluders are designed in an umbrella shape and use shape-memory metal materials with a certain strength. This ensures that the occluder can contract and be inserted into the blood vessels, while also ensuring that it can expand and seal the left atrial appendage after reaching it.

[0004] However, due to differences in gender, age, and body type among patients, the internal diameter of the left atrial appendage varies. Therefore, the left atrial appendage is generally manufactured in multiple sizes. When a left atrial appendage occlusion surgery is required, multiple occluders of different sizes need to be brought to the operating room. Through procedures such as catheter sheaths inserted into the heart, angiography is performed to determine the specific size of the left atrial appendage before selecting the appropriate occluder. The practicality of left atrial appendage occluders for patients with different left atrial appendage sizes is poor. It is not possible to design the occluder to freely adjust the expansion size of the left atrial appendage according to different sizes, making it inconvenient to use. Furthermore, using shape memory metal for the entire occluder also increases the cost.

[0005] Therefore, in order to solve the above-mentioned technical problems, this application proposes a highly adaptable left atrial appendage occlusion device. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a highly adaptable left atrial appendage occlusion device.

[0007] To achieve the above objectives, the present invention provides the following technical solution: comprising an occluder body, wherein the occluder is configured as an umbrella shape with an opening on one side, the open side of the occluder being the distal end, and the closed end of the occluder being the proximal end.

[0008] The occluder has a proximal external pin with an internal cavity at its center. A proximal internal internal pin with an internal cavity is fixedly installed inside the proximal external pin. The inner sidewall of the proximal internal pin has threads for adjustment and limiting. A threaded disc is inserted into the internal thread of the proximal internal pin. A sleeve is fixedly connected to the surface of the threaded disc. A rotating sleeve is rotatably connected to the outside of the sleeve through a bearing. A snap-fit ​​structure is provided inside the sleeve for connecting to and limiting the top of the catheter sheath.

[0009] The outer perimeter of the sleeve is connected to one end of the support rod by a deformable curved strip. The other end of the support rod is connected to the inner side of the plugger bracket by a deformable strip and corresponds to the position of the barbs. The support rod is provided with limiting structures on both sides near the rotating sleeve end to limit the movement trajectory of the support rod connected to the rotating sleeve end.

[0010] In this solution, the limiting structure includes storage grooves formed around the surface of the proximal inner pin for folding and storing the support rod. Multiple sets of storage grooves are provided for each support rod. A through groove is formed at the bottom of the storage groove, which connects to a cavity formed inside the proximal inner pin, for sliding displacement of the bent strip within the through groove. Limiting grooves are formed on both sides of the storage groove for sliding connection of the sliding rod. The sliding rod is fixedly installed on both sides of the end of the support rod connected to the bent strip, so as to realize the sliding of the sliding rod within the limiting groove and the sliding of the bent strip within the through groove, thereby limiting the positioning and movement trajectory of one end of the support rod.

[0011] In this embodiment, the snap-fit ​​structure includes multiple sets of slots for opening on the inner sidewall of the sleeve. The bottom ends of the slots are provided with locking grooves for limiting the position. Multiple sets of locking blocks installed at the tip of the catheter sheath are slidably inserted into the slots and locking grooves. This is used to insert the catheter sheath into the sleeve and insert the locking blocks into the slots and locking grooves, thereby rotating the sleeve and the threaded disc. This, in conjunction with the limiting structure, drives the contraction and expansion of the occluder support.

[0012] The design incorporates a threaded disc and a sleeve connected by an internal thread at the proximal end of the inner pin. A rotating sleeve is connected to the outside of the sleeve via a bearing. Deformation strips and bending strips are used to connect the support rod and the occluder bracket on the outside of the rotating sleeve. Through a snap-fit ​​structure and a conveying system, the threaded disc drives the sleeve to slide within the proximal inner pin. Under the constraint of the limiting structure, the support rod drives the occluder bracket to unfold. This allows for better control over the unfolding range of the occluder bracket, making it more adaptable to occlusion of left atrial appendages of different sizes.

[0013] The occluder stent features a gradually varying stiffness design from proximal to distal, balancing support and flexibility to adapt to various atrial appendage shapes while reducing distal atrial appendage damage.

[0014] It should be noted that the occluder support has a gradual decrease in stiffness from the proximal end to the distal end, which achieves both support and a certain degree of flexibility.

[0015] Furthermore, the proximal end of the occluder body is flat, while the distal end is hooked inward, which facilitates endothelialization of the proximal end while reducing damage to the atrial wall at the distal end.

[0016] Preferably, a flat proximal structure facilitates rapid endothelialization after occluder implantation, reducing the risk of device surface thrombosis (DRT).

[0017] The blocker body has a flow-blocking membrane sleeved on its outer side.

[0018] Preferably, the barbs use a forward barb structure to ensure a safe, stable, and non-deformable implantation process.

[0019] Preferably, the hook-shaped distal structure avoids puncturing the atrial appendage wall during implantation. The opening design makes the occlusion more stable and helps to increase the conformity of the occluder to the shape of the left atrial appendage. The barbed structure is safe, stable, easy to retrieve, and not easy to fall off during implantation. It can be repeatedly retrieved and unfolded, and the barbs do not deform. The porosity and thickness are moderate, which effectively prevents thrombus leakage.

[0020] The method of connecting the choke membrane and the occluder via a looping connection promotes endothelial cell proliferation and accelerates the endothelialization process. This method also reduces the risk of entanglement during implantation and significantly improves production efficiency.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. The threaded disc and sleeve are connected by the internal thread of the proximal inner pin, and the rotating sleeve is connected by the bearing on the outside of the sleeve. The support rod and the occluder bracket are connected by deformation strips and bending strips on the outside of the rotating sleeve. The threaded disc drives the sleeve to slide in the proximal inner pin through the snap-fit ​​structure and the conveying system. Under the restriction of the limiting structure, the support rod drives the occluder bracket to unfold. This makes it easier to limit the unfolding range of the occluder bracket to adapt to the occlusion of left atrial appendages of different sizes, and has greater adaptability.

[0023] 2. The occluder support features a gradually increasing stiffness design from proximal to distal, balancing support and flexibility to adapt to various atrial appendage shapes while reducing distal atrial appendage damage.

[0024] 3. The smooth proximal structure facilitates rapid endothelialization after occluder implantation, reducing the risk of device surface thrombosis (DRT);

[0025] 4. The hook-shaped distal structure avoids puncturing the atrial appendage wall during implantation, and the opening design makes the occlusion more stable and helps to increase the compliance of the occluder with the shape of the left atrial appendage;

[0026] 5. The use of a barbed structure ensures safety, stability, easy retrieval, and resistance to detachment during implantation. It can be repeatedly retrieved and unfolded, and the barbs do not deform. Furthermore, the porosity and thickness are moderate, effectively preventing thrombus leakage.

[0027] 6. The hanging method of connecting the choke membrane and the occluder is conducive to endothelial cell proliferation and accelerates the endothelialization process. The hanging method of connecting the choke membrane and the occluder reduces the risk of entanglement during implantation and also greatly improves production efficiency. Attached Figure Description

[0028] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, illustrate exemplary embodiments of the invention and, together with their description, serve to explain the invention and do not constitute an undue limitation thereof. In the drawings:

[0029] Figure 1 This is a schematic diagram of the front view structure of a highly adaptable left atrial appendage occlusion device according to the present invention;

[0030] Figure 2 This is a top view of a highly adaptable left atrial appendage occlusion device according to the present invention;

[0031] Figure 3 This is a bottom view of a highly adaptable left atrial appendage occlusion device according to the present invention;

[0032] Figure 4 This is a half-sectional view of a highly adaptable left atrial appendage occlusion device according to the present invention;

[0033] Figure 5 This is a schematic diagram of the overall structure of a highly adaptable left atrial appendage occlusion device according to the present invention;

[0034] Figure 6 This is a schematic diagram of the proximal internal pin in a highly adaptable left atrial appendage occluder according to the present invention;

[0035] Figure 7 This is a schematic diagram of the strut structure in a highly adaptable left atrial appendage occlusion device of the present invention;

[0036] Figure 8 This is a schematic diagram of the rotating sleeve in a highly adaptable left atrial appendage occlusion device of the present invention;

[0037] Figure 9 This is a schematic diagram of the threaded disc in a highly adaptable left atrial appendage occlusion device of the present invention.

[0038] 1-Barb; 2-Proximal external pin; 3-Blocking membrane; 4-Occluder support; 5-Proximal internal pin; 6-Support rod; 7-Deformation strip; 8-Limiting groove; 9-Through groove; 10-Receiving groove; 11-Sliding rod; 12-Bent strip; 13-Sleeve; 14-Threaded disc; 15-Catheter sheath tip; 16-Clamping block; 17-Slot; 18-Clamping groove; 19-Rotating sleeve; 20-Bearing; 21-Occluder body. Detailed Implementation

[0039] like Figure 1-9 As shown, the present invention provides a highly adaptable left atrial appendage occlusion device, including an occlusion device body 21. The occlusion device is configured as an umbrella shape with an opening on one side, the open side of the occlusion device being the distal end, and the closed end of the occlusion device being the proximal end.

[0040] The snap-fit ​​structure includes multiple sets of slots 17 for opening on the inner side wall of the sleeve 13. The bottom end of the slot 17 is provided with locking grooves 18 for limiting. Multiple sets of locking blocks 16 installed on the tip 15 of the catheter sheath are slidably inserted into the slots 17 and the locking grooves 18. This is used to insert the catheter sheath into the sleeve 13 and insert the locking blocks 16 into the slots 17 and the locking grooves 18, thereby rotating the sleeve 13 and the threaded disc 14. This, in conjunction with the limiting structure, drives the contraction and expansion of the occluder bracket 4.

[0041] like Figure 4-9 As shown, a proximal external pin 2 with an internal cavity is provided at the center of the proximal end of the occluder. A proximal internal internal pin 5 with an internal cavity is fixedly installed inside the proximal external pin 2. The inner side wall of the proximal internal pin 5 is provided with threads for adjustment and limiting. A threaded disc 14 is inserted into the internal thread of the proximal internal pin 5. A sleeve 13 is fixedly connected to the surface of the threaded disc 14. The outer side of the sleeve 13 is rotatably connected to the rotating sleeve 19 through the bearing 20. A snap-fit ​​structure for connecting and limiting the top of the catheter sheath is provided inside the sleeve 13.

[0042] like Figure 7 As shown, the outer periphery of the sleeve 13 is connected to one end of the support rod 6 by a bend 12 with deformable capability. The other end of the support rod 6 is connected to the inner side of the plugger bracket 4 by a deformable strip 7 and corresponds to the position of the barb 1. The support rod 6 is provided with limiting structures on both sides near the end of the rotating sleeve 19 to limit the movement trajectory of the support rod 6 connected to the end of the rotating sleeve 19.

[0043] When a left atrial appendage occlusion device is needed, the occluder body 21 is initially fully retracted and tubular, installed at the tip 15 of the puncture catheter sheath. The delivery system, consisting of a delivery cable and a guide sheath, transports the occluder body 21 to the required occlusion location in the left atrial appendage. The delivery system comprises a delivery device and accessories. The delivery device consists of a push cable and a delivery sheath, while the accessories consist of a dilator and a guide sheath. After the occluder body 21 is inserted into the opening of the left atrial appendage to be occluded through the puncture catheter, multiple sets of locking blocks 16 located on the outer side of the catheter sheath tip 15 are inserted into slots 17. The catheter sheath is then rotated to release the locking blocks. Block 16 is inserted into the corresponding slot 18 on the side, so that the rotation of the catheter sheath drives the sleeve 13 to rotate by the block 16 and the slot 18. The sleeve 13 drives the threaded disc 14 to rotate in the proximal inner pin 5. The threaded disc 14 rotates clockwise in the proximal inner pin 5, and slides the threaded disc 14 in the proximal inner pin 5 towards the inner side of the occluder body 21. At the same time, since the rotating sleeve 19 connected to the outside of the sleeve by the bearing 20 can remain fixed while the sleeve rotates and slides with the sliding of the threaded disc 14 and the sleeve in the proximal inner pin 5, the rotating sleeve 19 slides in the proximal inner pin 5.

[0044] like Figure 6 As shown, the limiting structure includes a storage groove 10 formed around the surface of the proximal inner pin 5 for storing and folding the support rod 6. Multiple sets of storage grooves 10 are provided for the support rod 6. A through groove 9 is formed at the bottom of the storage groove 10, which connects to the cavity formed inside the proximal inner pin 5, for sliding displacement of the bent strip 12 in the through groove 9. Limiting grooves 8 are formed on both sides of the storage groove 10 for sliding connection of the slide rod 11. The slide rod 11 is fixedly installed on both sides of the end of the support rod 6 connected to the bent strip 12, so that the sliding of the slide rod 11 in the limiting groove 8 cooperates with the sliding of the bent strip 12 in the through groove 9, thereby limiting the positioning and movement trajectory of one end of the support rod 6.

[0045] Simultaneously, the support rod 6 and the bent bar 12 slide within the through groove 9 opened in the proximal inner pin 5. The through groove 9 limits the displacement of the bent bar 12, and under the deformation capacity of the bent bar 12, the support rod 6 unfolds outward from the receiving groove 10. At this time, the sliding rods 11 set on both sides of the support rod 6 near the bent bar 12 slide within the limiting grooves 8 opened on the side walls of the receiving groove 10, thus limiting the displacement of the end of the support rod 6 connected to the rotating sleeve 19. By unfolding multiple sets of support rods 6 outward, the other end of the support rod 6 is pushed outward through the plugging device bracket 4 connected by the deformation strip 7, thereby unfolding the plugging device. The extent of the occluder bracket 4 is limited by the degree and distance of displacement of the threaded disc 14 within the proximal inner pin 5, and the expansion range of the occluder bracket 4 is limited by the strut 6, thereby adapting the occluder to occlude left atrial appendages of different sizes, making it more adaptable. The support range of the strut 6 is limited by the limiting between the threaded disc 14 and the thread on the inner side wall of the proximal inner pin 5. At the same time, deformation strips 7 and bending strips 12 are provided at the connection positions between the strut 6 and the occluder and between the strut 6 and the rotating sleeve 19, which can facilitate the strut 6 to rotate to a certain extent, achieving the effect of folding and unfolding.

[0046] The occluder support 4 has a gradual decrease in hardness from the proximal end to the distal end, which achieves both support and a certain degree of flexibility.

[0047] The design features a gradually increasing stiffness from proximal to distal, balancing support and flexibility to adapt to various atrial appendage shapes while reducing distal atrial appendage damage.

[0048] The proximal end of the occluder body 21 is flat, while the distal end is hooked inward, which facilitates endothelialization of the proximal end while reducing damage to the atrial wall of the distal end.

[0049] The smooth proximal structure facilitates rapid endothelialization after occluder implantation, reducing the risk of DRT thrombosis on the device surface;

[0050] The hook-shaped distal structure avoids puncturing the atrial appendage wall during implantation, and the opening design makes the occlusion more stable and helps to increase the conformity of the occluder to the shape of the left atrial appendage.

[0051] A flow-blocking membrane 3 is attached to the outside of the plug body 21 in a through-hole manner;

[0052] The barbs 1 are safe, stable, easy to retrieve, and not easy to fall off during the implantation process; they can be repeatedly retrieved and unfolded, and the barbs 1 do not deform. They also have moderate porosity and thickness, which effectively prevents thrombus leakage. The weaving method is conducive to endothelial cell proliferation and accelerates the endothelialization process. The hanging method connects the flow-blocking membrane 3 and the occluder, which reduces the risk of entanglement during the implantation process and greatly improves production efficiency.

[0053] The barb 1 uses a forward barb 1 structure to ensure a safe, stable, and non-deformable implantation process;

[0054] The barbs 1 are safe, stable, easy to retrieve, and not easy to fall off during the implantation process; they can be repeatedly retrieved and unfolded, and the barbs 1 do not deform.

[0055] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Those skilled in the art can readily implement the present invention based on the accompanying drawings and the above description. However, any modifications, alterations, or variations made by those skilled in the art without departing from the scope of the present invention, utilizing the disclosed technical content, are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, or variations made to the above embodiments based on the essential technology of the present invention are still within the protection scope of the present invention.

Claims

1. A highly adaptable left atrial appendage occlusion device, comprising an occlusion device body (21), wherein the occlusion device is configured as an umbrella shape with an opening on one side, the opening side of the occlusion device being the distal end, and the closed end of the occlusion device being the proximal end, characterized in that: The occluder has a proximal external pin (2) with an internal cavity at its center. A proximal internal pin (5) with an internal cavity is fixedly installed inside the proximal external pin (2). The inner wall of the proximal internal pin (5) is provided with threads for adjustment and limiting. A threaded disc (14) is inserted into the internal thread of the proximal internal pin (5). A sleeve (13) is fixedly connected to the surface of the threaded disc (14). The outer side of the sleeve (13) is rotatably connected to a rotating sleeve (19) through a bearing (20). A snap-fit ​​structure for connecting and limiting the top of the catheter sheath is provided inside the sleeve (13). The sleeve (13) is connected to one end of the support rod (6) by a deformable bent strip (12) around its outer perimeter. The other end of the support rod (6) is connected to the inside of the plugger bracket (4) by a deformable strip (7) and corresponds to the position of the barb (1). The support rod (6) is provided with limiting structures on both sides near the rotating sleeve (19) to limit the movement trajectory of the support rod (6) connected to the rotating sleeve (19).

2. The highly adaptable left atrial appendage occlusion device according to claim 1, characterized in that: The limiting structure includes a storage groove (10) formed around the surface of the proximal inner pin (5) for storing and folding the support rod (6). The storage groove (10) is provided in multiple sets corresponding to the support rod (6). The bottom of the storage groove (10) is provided with a through groove (9) that connects to the cavity inside the proximal inner pin (5) for sliding displacement of the bent strip (12) within the through groove (9). The two side walls of the storage groove (10) are provided with limiting grooves (8) for sliding connection of the slide rod (11). The slide rod (11) is fixedly installed on both sides of the end of the support rod (6) connecting the bent strip (12), so that the sliding of the slide rod (11) within the limiting groove (8) cooperates with the sliding of the bent strip (12) within the through groove (9), thereby limiting the movement trajectory of one end of the support rod (6).

3. The highly adaptable left atrial appendage occlusion device according to claim 2, characterized in that: The buckle structure includes multiple sets of slots (17) for opening on the inner side wall of the sleeve (13). The bottom end of the slot (17) is provided with a retaining groove (18) for limiting. Multiple sets of retaining blocks (16) installed on the tip (15) of the catheter sheath are slidably inserted into the slot (17) and the retaining groove (18) for inserting the catheter sheath into the sleeve (13) and inserting the retaining blocks (16) into the slot (17) and the retaining groove (18), thereby rotating the sleeve (13) and the threaded disc (14), and cooperating with the limiting structure to drive the contraction and expansion of the occluder support (4).

4. The highly adaptable left atrial appendage occlusion device according to claim 3, characterized in that: The occluder support (4) has a gradually decreasing hardness from the proximal end to the distal end, which achieves both support and a certain degree of flexibility.

5. A highly adaptable left atrial appendage occlusion device according to claim 4, characterized in that: The occluder body (21) has a flat surface at the proximal end and an inward hook shape at the distal end, which can achieve easy endothelialization of the proximal end while reducing damage to the atrial wall at the distal end.

6. A highly adaptable left atrial appendage occlusion device according to claim 5, characterized in that: The plug body (21) is fitted with a flow-blocking membrane (3) on the outside.

7. A highly adaptable left atrial appendage occlusion device according to claim 6, characterized in that: The barb (1) uses a forward barb (1) structure to ensure a safe, stable and non-deformable implantation process.

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