Left atrial appendage occluder, left atrial appendage occluder assembly and preparation method

Abstract

The invention relates to the field of medical instruments, and discloses a left auricle occluder, a left auricle occluder assembly and a preparation method of the left auricle occluder. The left atrial appendage occluder includes a support frame having a proximal end and a distal end and including a first support frame and a second support frame, and a collection assembly. The first supporting frame is of a closed structure and is provided with a first near end face, a first far end face and a first body. The second support frame has a second proximal face and a second body extending distally from the second proximal face. The first supporting frame and the second supporting frame are connected at the near end of the supporting frame, and the first near end face is attached to the second near end face. The first body has a first height, the second body has a second height, and the first height is greater than the second height. By arranging the first supporting frame and the second supporting frame which are connected at the near end, reliable flow choking performance and anchoring stability are achieved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a cardiovascular implantable medical device. Background Technology

[0002] Atrial fibrillation is the most common sustained arrhythmia, which can lead to complications such as thrombosis and stroke, potentially causing serious consequences. Thrombi caused by atrial fibrillation often originate from thrombi formed in the left atrium that break off. Previous studies have found that over 90% of cardiac strokes originate in the left atrial appendage. Transcatheter left atrial appendage occlusion (TALA) uses a minimally invasive technique to block blood flow between the left atrial appendage and the left atrium, preventing thrombi from breaking off from the left atrial appendage and entering the bloodstream, thus preventing stroke.

[0003] During the procedure, the left atrial appendage occluder is delivered via a long, thin catheter through the body's tortuous blood vessels to reach the implantation site. After implantation, it should remain stable in place, without displacement or dislodgement, and the left atrial appendage orifice should be immediately closed without residual shunt. Continuous improvement of the left atrial appendage occluder structure to achieve better stability and flow obstruction remains clinically significant. Summary of the Invention

[0004] This application provides a left atrial appendage occluder that achieves better anchoring stability and flow obstruction effect through an improved support frame.

[0005] This application provides a left atrial appendage occluder, including a braided support frame and an assembly, the support frame having a proximal end and a distal end, and including a first support frame and a second support frame;

[0006] The first support frame is a closed structure and has a first proximal end face, a first distal end face and a first main body, with the first main body located between the first proximal end face and the first distal end face;

[0007] The second support frame has a second proximal face and a second body, the second body extending from the second proximal face to the distal end;

[0008] The first support frame and the second support frame are connected at the proximal end, and the first proximal end face and the second proximal end face are in contact;

[0009] The first entity has a first height, and the second entity has a second height, with the first height being greater than the second height.

[0010] In some embodiments, the assembly includes a first assembly element for gathering the distal end of the first support frame and not protruding beyond the contour of the first distal end face; and also includes a second assembly element for gathering the proximal end of the support frame.

[0011] In some embodiments, the second assembly element is used to converge the proximal end of the first support frame; the assembly also includes a third assembly element that converges the proximal end of the second support frame; the second assembly element is connected to the third assembly element.

[0012] In some embodiments, the first support frame includes a first woven mesh, which includes a plurality of first woven filaments; the second support frame includes at least one layer of second woven mesh, which includes a plurality of second woven filaments.

[0013] In some embodiments, the number of first braiding filaments is at least 72, the number of second braiding filaments is at least 144, the diameter of the first braiding filament is larger than the diameter of the second braiding filament, and the diameter of the second braiding filament is 20%-60% of the diameter of the first braiding filament.

[0014] In some embodiments, the second support frame is arranged inside the first support frame; the assembly also includes a fourth assembly element for converging the distal end of the second support frame, the second height being 20%-80% of the first height.

[0015] In some implementations, the second support frame is arranged outside the first support frame, and the second height is 20%-50% of the first height.

[0016] In some embodiments, the first woven mesh further includes multiple third woven wires, which together with the first woven wires form the first woven mesh; the diameter of the third woven wires is larger than the diameter of the first woven wires, and the diameter of the first woven wires is 20%-90% of the diameter of the third woven wires.

[0017] In some embodiments, at least two microplanes are arranged on the third braided filament, and at least one anchoring structure is arranged on each microplane. Multiple anchoring structures are distributed around the outer surface of the first body and form at least two anchoring zones axially.

[0018] This application provides a left atrial appendage occluder assembly, including the left atrial appendage occluder as described above, and also including a woven cover portion, which is detachably connected to the proximal end of the left atrial appendage occluder.

[0019] This application provides a method for preparing a left atrial appendage occluder, which includes the following steps:

[0020] S1, micro-planes are forged and pressed into the third braided filament to obtain a third braided filament including multiple micro-planes, and the micro-planes have a fixed spacing between them;

[0021] S2, the multiple micro-planes of the third braided filament are engraved to obtain the engraved part, and then the engraved part is heat-treated to shape it to form an anchoring structure located on the micro-plane;

[0022] S3, weave multiple first braiding filaments and multiple third braiding filaments obtained in S2 into a net to obtain a first braided net; weave multiple second braiding filaments into a net to obtain a second braided net;

[0023] S4, Select the required length of the first woven mesh, use the first collection element to gather one end of the first woven mesh, flip the first woven mesh inside and out so that the first collection element is located inside the first woven mesh, and the anchoring structure is distributed on the outer surface of the first woven mesh;

[0024] S5, Select the required length of the second woven mesh, fold the second woven mesh in half so that the two ends of the second woven mesh overlap, and place the folded second woven mesh over or inside the first woven mesh so that the overlapping ends of the second woven mesh coincide with the untied end of the first woven mesh. Use the second gathering element to gather the overlapping ends of the first and second woven meshes; or

[0025] Select the desired length of the second braided mesh, place the second braided mesh inside the first braided mesh, use the second gathering element to gather one end of the second braided mesh together with the ungathered end of the first braided mesh, and use the fourth gathering element to gather the other end of the second braided mesh; or

[0026] Select the desired length of the second woven mesh, fold it in half so that the two ends of the second woven mesh overlap, and use the third gathering element to gather the overlapping ends of the second woven mesh. Use the second gathering element to gather the ungathered end of the first woven mesh, then slip the second woven mesh over the first woven mesh or place it inside the first woven mesh, and connect the second gathering element to the third gathering element; or

[0027] Select the desired length of the second braided net, use the third gathering element to gather one end of the second braided net, use the fourth gathering element to gather the other end of the second braided net, use the second gathering element to gather the ungathered end of the first braided net, place the second braided net inside the first braided net, and connect the second gathering element to the third gathering element;

[0028] S6, insert molds of corresponding specifications into the first and second woven nets obtained in S5, and perform heat setting treatment on the first and second woven nets to form the first support frame and the second support frame.

[0029] In some methods for preparing left atrial appendage occluders, step S1 further includes selecting the spacing between adjacent microplanes so that the spacing of the anchoring structure is adapted to different specifications of the left atrial appendage occluder.

[0030] This application achieves at least the following technical effects:

[0031] 1) By setting up a closed first support frame, the left atrial appendage occluder has a suitable radial support force, which is beneficial to the implantation stability of the left atrial appendage occluder in the left atrial appendage.

[0032] 2) The first support frame and the second support frame are connected at the proximal end, and the first proximal end face and the second proximal end face are in contact. Blood flow cannot pass through the contacted first proximal end face and the second proximal end face, so that the left atrial appendage occluder has sufficient flow resistance at the proximal end. The first support frame and the second support frame connected to each other at the proximal end further ensure that the first proximal end face and the second proximal end face are in contact with each other. Even if the left atrial appendage occluder is in a constrained form when it passes through the delivery catheter, it needs to be stretched from the proximal end to the distal end to form a slender compression state. When it is released, it passes through the delivery catheter and then returns to the preset form from the distal end to the proximal end. The first proximal end face and the second proximal end face are still reliably in contact. The reliability of the structure is not affected by the large deformation during the retrieval and release process.

[0033] 3) The second body extends from the second proximal end to the distal end, which enhances the flow resistance of the first body, that is, enhances the flow resistance of the left atrial appendage occluder. Even during implantation, due to individual differences in anatomical structure, a small part of the proximal end of the left atrial appendage occluder support frame may be exposed outside the left atrial appendage orifice. At this time, due to the enhancement of the flow resistance of the first body by the second body, the effectiveness of the left atrial appendage occluder implantation can still be guaranteed.

[0034] 4) The second body has a smaller height than the first body, which helps the left atrial appendage occluder maintain a controllable radial profile when stretched into a slender and compressed state. This makes it easier to deliver the device through a slender catheter, and the catheter size is controllable, making it more compatible with human blood vessels.

[0035] 5) The second support frame assists the first support frame in achieving a better flow obstruction effect, while also providing some support to the first support frame. The enhanced radial support force is beneficial to the stability of the left atrial appendage occluder at the implantation position, preventing displacement and detachment.

[0036] 6) The first assembly element does not protrude from the first distal surface profile, reducing the potential risk to the distal left atrial appendage during the release process of the left atrial appendage occluder and improving safety. Attached Figure Description

[0037] The following is a brief introduction to the accompanying drawings used in the description of the embodiments of this application:

[0038] Figure 1 This is a schematic diagram of the structure of a left atrial appendage occluder under constraint configuration according to an embodiment of this application;

[0039] Figure 2 This is a schematic diagram of the structure of a left atrial appendage occluder in a preset configuration according to an embodiment of this application;

[0040] Figure 3 This is a schematic diagram of the structure of a left atrial appendage occluder when the first outer surface is subjected to radial force, according to an embodiment of this application.

[0041] Figure 4 This is a schematic diagram of the structure of a left atrial appendage occluder provided in an embodiment of this application;

[0042] Figure 5 This is a schematic diagram of another left atrial appendage occluder provided in an embodiment of this application;

[0043] Figure 6 This is a schematic diagram of the structure of the second support frame of a left atrial appendage occluder provided in an embodiment of this application;

[0044] Figure 7 This is a schematic diagram of the structure of a left atrial appendage occluder provided in an embodiment of this application;

[0045] Figure 8 This is a schematic diagram of another left atrial appendage occluder provided in the embodiments of this application;

[0046] Figure 9 This is a schematic diagram of a composite element with a threaded hole provided in an embodiment of this application;

[0047] Figure 10 This is a partial schematic diagram of a left atrial appendage occluder support frame provided in an embodiment of this application;

[0048] Figure 11 This is a schematic diagram of the structure of a left atrial appendage occluder assembly provided in an embodiment of this application. Detailed Implementation

[0049] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the specific implementation methods of this application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without creative effort.

[0050] To keep the drawings concise, each drawing only schematically represents the parts relevant to the application; these do not represent the actual structure of the product. Furthermore, for ease of understanding, in some drawings, components with the same structure or function are shown only schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one."

[0051] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0052] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0053] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) are relative rather than absolute when describing the structure and movement of the various components, and are not intended to limit the direction of the product during actual use.

[0054] In the embodiments of this application, "proximal" and "distal" are used to describe the position or orientation of the associated (or described) object (hereinafter referred to as the associated object) relative to the operator from the perspective of the operator (e.g., a doctor or surgeon). For example, "proximal" refers to the end closer to the operator during normal operation of the medical device; "distal" refers to the end further away from the operator during normal operation of the medical device, or the end that first enters the patient's body. For example, the "proximal" of A refers to the end of A closer to the operator; the "distal" of A refers to the end of A further away from the operator. Alternatively, the "proximal" of A refers to the end of A further away from the patient (or the affected area, or the occluder implantation site); the "distal" of A refers to the end of A closer to the patient (or the affected area, or the occluder implantation site).

[0055] This application provides a left atrial appendage occluder 10, which, after implantation, fits tightly against the inner wall of the left atrial appendage and is stabilized in the implantation position with sufficient radial support, preventing displacement or even dislodgement due to heartbeats or blood flow. The left atrial appendage occluder 10 provided in this application has a preset shape and a constraint shape. (See attached...) Figure 1 As shown, the left atrial appendage occluder 10 is connected to the delivery device 32 at its proximal end. It is stretched into a slender shape from the proximal end to the distal end and enters the sheath 31. At this time, the left atrial appendage occluder 10 is constrained by the sheath 31, i.e., it is in a constrained state. When the left atrial appendage occluder 10 is delivered to the implantation site by the delivery device 32 through the sheath 31, it is pushed out of the sheath 31 by the delivery device 32 and returns to the preset shape from the distal end to the proximal end. After implantation, the delivery device 32 separates from the left atrial appendage occluder 10, and the delivery device 32 and the sheath 31 are withdrawn from the human body.

[0056] As attached Figure 2As shown, the left atrial appendage occluder 10 includes a woven support frame 11 and an assembly 12. The support frame 11 has a proximal end 113 and a distal end 114. The support frame 11 includes a first support frame 111 and a second support frame 112, both of which can be woven from elastic metal wire and are connected at the proximal end 113. Understandably, the first support frame 111 forms the main profile of the support frame 11, plays a major role in the radial support force of the support frame 11, and is set to have a certain metal coverage, i.e., a certain flow-blocking capacity; the second support frame 112 plays an auxiliary role in the performance of the support frame 11, strengthens the radial support force of the first support frame 111, and is set to have a higher metal coverage, thereby strengthening the flow-blocking capacity of the first support frame 111.

[0057] The first support frame 111 has a closed structure. In the preset configuration of the left atrial appendage occluder 10, the first support frame 111 has a first distal end face 1111 at its distal end and a first proximal end face 1112 at its proximal end, and also has a first body 1113 connected between the first distal end face 1111 and the first proximal end face 1112, the first body 1113 having a first height 1118. The first distal end face 1111, the first proximal end face 1112 and the first body 1113 are preferably integrally formed.

[0058] The first body 1113 has a first outward surface 1114. In some preferred embodiments, the first outward surface 1114 is an arc-shaped surface that curves outward toward the first support frame 111. The areas on both sides of the radial midline of the first support frame 111 form the regions with the highest curvature of the first outward surface 1114. After the left atrial appendage occluder 10 is implanted, when the left atrial appendage contracts, as shown in the attached... Figure 3 As shown, the first outward surface 1114 will deform, transmitting the deformation to the proximal and distal ends of the first support frame 111; the regions on both sides of the radial midline of the first outward surface 1114 can preferentially bear the pressure of left atrial appendage contraction, delaying the transmission of deformation to the proximal and distal ends of the first support frame 111, so that the deformation of the first support frame 111 is controllable under contraction pressure, so as to stably fit the implantation position.

[0059] In other preferred embodiments, such as Figure 4As shown, the diameter of the first main body 1113 decreases continuously from the proximal end to the distal end, and the cross-section of the first main body 1113 can be trapezoidal. With this configuration, the diameter of the support frame 11 continuously decreases from the proximal end to the distal end. When the left atrial appendage occluder 10 is implanted into the left atrial appendage, the smaller-diameter distal end is located deeper within the narrower left atrial appendage, while the larger-diameter proximal end is located near the wider opening of the left atrial appendage. The first outward surface 1114 conforms to the inner wall of the left atrial appendage with a larger surface area. When the left atrial appendage contracts, the contraction pressure is applied more continuously to different positions of the first outward surface 1114. Under the action of contraction pressure, the deformation of the first support frame 111 is small at each position from the distal end to the proximal end, stably conforming to the implantation position and optimizing the implantation effect.

[0060] Understandably, in practical applications, different preferred embodiments may be used in a single implementation or in combination of different implementation methods for different left atrial appendage anatomical structures.

[0061] In some implementations, as shown in the appendix Figure 2 As shown, the first distal surface 1111 is an arc-shaped surface connected to the first outward surface 1114; in other embodiments, as shown in the attached figure... Figure 5 As shown, the distal central portion of the first support frame 111 has a first recess 1115, and the first distal surface 1111 can be an annular surface. Similarly, the proximal central portion of the first support frame 111 has a second recess 1116, and the first proximal surface 1112 can also be an annular surface. Both the first recess 1115 and the second recess 1116 extend into the internal space 1117 of the first support frame 111. The distal end of the first recess 1115 is connected to the first distal surface 1111, and the proximal end of the second recess 1116 is connected to the first proximal surface 1112. The first recess 1115 and the second recess 1116 enhance the deformation resistance of the first distal surface 1111 and the first proximal surface 1112, further providing radial support force for the left atrial appendage occluder 10 and enhancing the stability of the left atrial appendage occluder 10 after implantation. Since the first support frame 111 forms the main profile of the support frame 11, it can be understood that the central portion of the proximal end 113 of the support frame 11 also has a recessed area extending toward the distal end 114 of the support frame 11.

[0062] The outline of the internal space 1117 of the first support frame 111 is constrained by the first outward surface 1114, the first distal surface 1111, and the first proximal surface 1112.

[0063] The second support frame 112 has a second proximal end face 1122 at its proximal end, and a second body 1123 is connected to the second proximal end face 1122 and extends toward the distal end 114. The second body 1123 has a second height 1124. The second proximal end face 1122 and the second body 1123 are preferably integrally formed.

[0064] The second proximal facet 1122 is in contact with the first proximal facet 1112, and the first support frame 111 and the second support frame 112 are fixedly connected at the proximal end 113, thereby strengthening the fit between the first proximal facet 1112 and the second proximal facet 1122. With this configuration, even if the left atrial appendage occluder 10 is repeatedly retrieved and released through the sheath 31, the first proximal facet 1112 and the second proximal facet 1122 will still reliably fit together. The large deformation caused by the stretching from the proximal end to the distal end during retrieval and the restoration of the preset shape during release will not affect the reliability of the left atrial appendage occluder 10 structure. Furthermore, it enhances the flow obstruction effect of the left atrial appendage occluder 10 at the left atrial appendage orifice, enabling immediate closure of the left atrial appendage orifice after implantation.

[0065] Furthermore, in a preferred embodiment, the outer surface of the second body 1123 is also an arc-shaped surface, curving outwards towards the second support frame 112. In other preferred embodiments, the diameter of the second body 1123 also continuously decreases from the proximal end to the distal end. Understandably, the profile of the second body 1123 is set according to the profile of the overlapping portion of the first body 1113, so that the overlapping portion of the second body 1123 and the first body 1113 fits snugly, thereby facilitating the flow-blocking performance of the support frame 11 and strengthening the radial support force of the support frame 11, ensuring that the left atrial appendage occluder 10 does not shift or fall off at the implantation position.

[0066] The collection component 12 converges at multiple points on the proximal end 113 and distal end 114 of the support frame 11, forming a closed structure of the first support frame 111. When interacting with the left atrial appendage tissue, this closed structure more easily generates a counterforce, strengthening the support capability of the left atrial appendage occluder 10. The collection component 12 can be located on the axis of the left atrial appendage occluder 10, ensuring the coaxiality of the occluder 10 and making it more stable after implantation. The collection component 12 and the end of the support frame 11 are press-fitted and can be made of stainless steel, nickel-titanium alloy, or other biocompatible metal materials, preferably stainless steel.

[0067] The assembly 12 includes a first assembly element 121 that converges the distal end of the first support frame 111. In some embodiments, such as Figure 5 As shown, the first collection element 121 is completely located in the first recessed area 1115, and the distal end of the first collection element 121 is substantially flush with the first distal end surface 1111; in other embodiments, such as Figure 7 As shown, the first assembly element 121 is located in the internal space 1117 of the first support frame 111. The arrangement of the first assembly element 121, which does not protrude from the contour of the first distal surface 1111, reduces the potential risk to the distal end of the left atrial appendage during the release of the left atrial appendage occluder 10, and improves the safety of the left atrial appendage occluder 10 during the release process.

[0068] The assembly 12 also includes a second assembly element 122, which converges the proximal end of the first support frame 111 or converges the proximal end 113 of the support frame 11. When the second assembly element 122 converges the proximal end of the first support frame 111, a third assembly element 123 can also be provided to converge the proximal end of the second support frame 112, and the second assembly element 122 is connected to the third assembly element 123.

[0069] like Figure 6 , Figure 7 In the preferred embodiment shown, the second support frame 112 is adapted to be arranged within the internal space 1117 of the first support frame 111. At this time, the second collection element 122 is located proximal to the third collection element 123 and within the second recess 1116. The proximal end of the second collection element 122 is substantially flush with the first proximal end face 1112 to facilitate the endothelialization process of the left atrial appendage occluder 10. The collection assembly 12 may also include a fourth collection element 124, converging the distal end of the second support frame 112. The distal end of the second support frame 112 has a second distal end face 1121, and the second body 1123 is located between the second distal end face 1121 and the second proximal end face 1122. The second height 1124 is 20%-80% of the first height 1118, so that the second support frame 112 provides sufficient radial support and flow-blocking capacity for the left atrial appendage occluder 10. With this configuration, during implantation, even if a small portion of the proximal end 113 of the support frame 11 may protrude outside the left atrial appendage opening due to individual anatomical differences, the left atrial appendage occluder 10 still has sufficient flow-blocking performance.

[0070] In other embodiments, such as the appendix Figure 8 As shown, the second support frame 112 can be arranged outside the first support frame 111, and the third assembly element 123 is located near the proximal end of the second assembly element 122. Understandably, the proximal end of the third assembly element 123 does not protrude beyond the contour of the second proximal end face 1122. The second height 1124 is 20%-50% of the first height 1118. This arrangement ensures that the arrangement of the first outward surface 1114 and its interaction with the inner wall of the left atrial appendage are not affected by the second support frame 112 being located outside the first support frame 111, thus guaranteeing the stability of the left atrial appendage occluder 10 and avoiding potential displacement risks.

[0071] The second assembly element 122 and the third assembly element 123 can be fixedly connected by welding or threaded structure.

[0072] As attached Figure 9As shown, in some embodiments, the second assembly element 122 is provided with a threaded hole, including an inner layer element 1221 and an outer layer element 1222, both hollow and coaxially fitted. The inner wall of the inner layer element 1221 has an internal thread 12211. When the second assembly element 122 retracts the proximal end 113 of the support frame 11, the internal thread 12211 is adapted to the external thread of the delivery device 32. When the second assembly element 122 retracts the proximal end of the first support frame 111 and the third assembly element 123 retracts the proximal end of the second support frame 112, the internal thread 12211 is adapted to the external thread of the third assembly element 123 and the external thread of the delivery device 32. This can be used to connect the first support frame 111 and the second support frame 112, and to connect the left atrial appendage occluder 10 to the delivery device 32, thereby achieving efficient connection and complete separation of the left atrial appendage occluder 10 and the delivery device 32.

[0073] like Figure 10 As shown in the partial view of the support frame 11, the first support frame 111 includes a first woven mesh 1119, which is woven from multiple first woven wires 11191 and multiple third woven wires 11192. In some embodiments, the number of first woven wires 11191 is greater than the number of third woven wires 11192, with the number of first woven wires 11191 ranging from 72 to 480; and the number of third woven wires 11192 ranging from 2 to 20, preferably 6 to 16. The diameter of the third braided filament 11192 can be larger than the diameter of the first braided filament 11191. The diameter of the first braided filament 11191 ranges from 0.025 to 0.250 mm, preferably from 0.050 to 0.125 mm; the diameter of the third braided filament 11192 ranges from 0.075 to 0.750 mm, preferably from 0.100 to 0.400 mm. In some embodiments, the diameter of the first braided filament 11191 is 20% to 90% of the diameter of the third braided filament 11192. This arrangement provides the first support frame 111 with good radial support and a relatively dense braided structure, resulting in a flow-blocking effect. This arrangement also facilitates the attachment of myocardial cells to the braided mesh after implantation of the left atrial appendage occluder 10, accelerating the endothelialization process of the left atrial appendage occluder 10.

[0074] The second support frame 112 includes a second woven mesh 1125, which is woven from multiple second woven wires 11251. The number of second woven wires 11251 ranges from 144 to 960. The diameter of the second woven wires 11251 ranges from 0.010 to 0.125 mm, preferably from 0.020 to 0.090 mm. The diameter of the second woven wires 11251 is smaller than the diameter of the first woven wires 11191. In some embodiments, the diameter of the second woven wires 11251 is 20% to 60% of the diameter of the first woven wires 11191.

[0075] In some embodiments, the braiding pitch of the first support frame 111 and the second support frame 112 are different. The braiding pitch of the first support frame 111 is 20-90 mm, and the braiding pitch of the second support frame 112 is 15-85 mm, wherein the braiding pitch of the first support frame 111 is larger than that of the second support frame 112. By adjusting the braiding pitch, the metal coverage of the second support frame 112 is increased, the mesh porosity of the left atrial appendage occluder 10 is reduced, the inflow of blood is reduced, and the flow obstruction effect is enhanced. The second support frame 112 may include multiple layers of second braided mesh 1125 to further increase the flow obstruction area of ​​the left atrial appendage occluder 10 and improve the flow obstruction effect.

[0076] Understandably, the second support frame 112 may include polymeric braided filaments, such as braided filaments made of polymeric materials such as polylactic acid, polyurethane, and polydioxanone (PDO).

[0077] The design of the anchoring structure 115 in the embodiment of this application is described below with reference to the accompanying drawings:

[0078] As attached Figure 4 As shown, a plurality of anchoring structures 115 protruding from the first outward surface 1114 of the first support frame 111 are distributed. The anchoring structures 115 penetrate the inner wall tissue of the left atrial appendage to assist in fixing the left atrial appendage occluder 10. Depending on the different specifications of the left atrial appendage occluder 10, the plurality of anchoring structures 115 are offset by a certain distance in both the axial and radial directions of the left atrial appendage occluder 10, and at least two anchoring regions are formed in the axial direction, increasing the anchoring range and anchoring force. In a preferred embodiment, the plurality of anchoring structures 115 are evenly distributed at two different axial heights on the first outward surface 1114, forming two annular anchoring regions. Specifically, the anchoring structures 115 are disposed on the third braided wire 11192, with at least two microplanes 11193 arranged on each third braided wire 11192, and at least one anchoring structure 115 arranged on each microplane 11193. The anchoring structure 115 utilizes the larger radial dimension of the third braided filament 11192 to provide stronger anchoring force. Simultaneously, the larger radial dimension increases the surface area of ​​contact between the braided filament and the left atrial appendage tissue, contributing to improved stability and fixation of the anchoring structure 115. The anchoring structure 115 is sheet-like, and after heat setting, its shape can be C-shaped or U-shaped, with its end pointing towards the proximal end of the left atrial appendage occluder 10. Its length is 1-4 mm, and the specific shape and length are not limited in this application.

[0079] This application provides a left atrial appendage occlusion device assembly, the structure of which is as follows: Figure 11As shown, the device includes a left atrial appendage occluder 10 and a cover portion 20, the cover portion 20 including a woven third support frame 21. The assembly 12 further includes a fifth assembly element 125, which gathers the distal end of the third support frame 21; and a sixth assembly element 126, which gathers the proximal end of the third support frame 21. The fifth assembly element 125 is detachably connected to the second assembly element 122, enabling the connection and disconnection of the left atrial appendage occluder 10 and the cover portion 20. The sixth assembly element 126 is detachably connected to the delivery device 32, enabling effective connection and complete separation of the left atrial appendage occluder assembly and the delivery device 32. In some embodiments, the second assembly element 122 has a threaded hole, and the fifth assembly element 125 has an external thread, the threaded hole of the second assembly element 122 being adapted to the external thread of the fifth assembly element 125. The radial diameter of the cover portion 20 is larger than the radial diameter of the left atrial appendage occluder 10. The left atrial appendage occluder 10 and the cover portion 20 are detachably connected, so that the left atrial appendage occluder 10 can be used not only alone, but also in combination with the cover portion 20, realizing more specifications of combination between the left atrial appendage occluder 10 and the cover portion 20. The appropriate size of the left atrial appendage occluder assembly can be selected according to the actual clinical needs, thus expanding the applicability of the left atrial appendage occluder assembly.

[0080] This application provides a method for preparing a left atrial appendage occluder 10, which is further illustrated by the following example preparation method.

[0081] Preparation Method 1

[0082] A method for preparing a left atrial appendage occluder 10 includes the following steps:

[0083] S1, a micro-plane 11193 is locally forged into the third braid filament 11192 to obtain a third braid filament 11192 including multiple micro-planes 11193, and there is a fixed spacing between adjacent micro-planes 11193.

[0084] S2, the multiple micro-planes 11193 of the third braided filament 11192 are engraved to obtain the engraved part, and the engraved part is heat-treated and shaped to form at least one anchoring structure 115 located on the micro-plane 11193.

[0085] S3, multiple first braiding filaments 11191 and multiple third braiding filaments 11192 obtained in step S2 are braided into a tubular first braided mesh 1119; multiple second braiding filaments 11251 are braided into a tubular second braided mesh 1125;

[0086] S4, select the required length of the first woven mesh 1119, use the first collection element 121 to gather one end of the first woven mesh 1119, flip the first woven mesh 1119 inside and out, so that the first collection element 121 is located inside the first woven mesh 1119, and the anchoring structure 115 is distributed on the outer surface of the first woven mesh 1119.

[0087] S5, select the required length of the second woven net 1125, fold the second woven net 1125 in half so that the two ends of the second woven net 1125 overlap, put the folded second woven net 1125 over the first woven net 1119 or place it inside the first woven net 1119 so that the overlapping ends of the second woven net 1125 overlap with the untied end of the first woven net 1119, and use the second gathering element 122 to gather the overlapping ends of the first woven net 1119 and the second woven net 1125;

[0088] S6, insert molds of corresponding specifications into the first woven mesh 1119 and the second woven mesh 1125 obtained in step S5, and perform heat setting treatment on the first woven mesh 1119 and the second woven mesh 1125 to form the first support frame 111 and the second support frame 112.

[0089] Preparation Method 2

[0090] A method for preparing a left atrial appendage occluder 10 includes the following steps:

[0091] Steps S1-S4 are the same as in preparation method one, and will not be repeated here. They also include...

[0092] S5, Select the required length of the second braided net 1125, place the second braided net 1125 inside the first braided net 1119, use the second gathering element 122 to gather one end of the second braided net 1125 together with the ungathered end of the first braided net 1119, and use the fourth gathering element 124 to gather the other end of the second braided net 1125.

[0093] S6, insert molds of corresponding specifications into the first woven mesh 1119 and the second woven mesh 1125 obtained in step S5, and perform heat setting treatment on the first woven mesh 1119 and the second woven mesh 1125 to form the first support frame 111 and the second support frame 112.

[0094] Preparation method three

[0095] A method for preparing a left atrial appendage occluder 10 includes the following steps:

[0096] Steps S1-S4 are the same as in preparation method one, and will not be repeated here. They also include...

[0097] S5, select the required length of the second woven mesh 1125, fold the second woven mesh 1125 in half so that the two ends of the second woven mesh 1125 overlap, and use the third gathering element 123 to gather the overlapping two ends of the second woven mesh 1125; use the second gathering element 122 to gather the ungathered end of the first woven mesh 1119, and then put the second woven mesh 1125 over the first woven mesh 1119 or inside the first woven mesh 1119, and connect the second gathering element 122 and the third gathering element 123 by welding or threaded structure;

[0098] S6, insert molds of corresponding specifications into the first woven mesh 1119 and the second woven mesh 1125 obtained in step S5, and perform heat setting treatment on the first woven mesh 1119 and the second woven mesh 1125 to form the first support frame 111 and the second support frame 112.

[0099] Preparation method four

[0100] A method for preparing a left atrial appendage occluder 10 includes the following steps:

[0101] Steps S1-S4 are the same as in preparation method one, and will not be repeated here. They also include...

[0102] S5, select the required length of the second braided mesh 1125, use the third gathering element 123 to gather one end, use the fourth gathering element 124 to gather the other end, use the second gathering element 122 to gather the ungathered end of the first braided mesh 1119, then place the second braided mesh 1125 inside the first braided mesh 1119, and connect the second gathering element 122 and the third gathering element 123 by welding or threaded structure;

[0103] S6, insert molds of corresponding specifications into the first woven mesh 1119 and the second woven mesh 1125 obtained in step S5, and perform heat setting treatment on the first woven mesh 1119 and the second woven mesh 1125 to form the first support frame 111 and the second support frame 112.

[0104] In the embodiments of the above preparation method, step S1 further includes selecting a fixed spacing between adjacent microplanes 11193, including selecting a spacing in the axial and / or radial direction, so that the spacing between the anchoring structures 115 can be adapted to different specifications of the left atrial appendage occluder 10.

[0105] In step S3, the braided yarn is wound around the spindle of the braiding machine to form a braided net. The ratio of the number of spindles of the braiding machine to the number of the first braided yarn 11191 or the second braided yarn 11251 is 1:1 to 1:4.

[0106] Step S3 may also include forging the first braided wire 11191 to obtain a first braided wire 11191 with a circumferential width greater than its thickness, and then weaving it with the third braided wire 11192 to form a first braided mesh 1119.

[0107] Step S5 also includes folding the second woven mesh 1125 from one end to the other multiple times or stacking multiple single-layer second woven meshes 1125 to obtain a second woven mesh 1125 with a multi-layer structure before gathering it.

[0108] The step numbers S1, S2, etc. in the above preparation method are not used to limit the order in which the steps are performed. The order in which the steps are performed can be adjusted as needed.

[0109] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of this application. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principles of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A left atrial appendage occlusion device, comprising a woven support frame and an assembly, characterized in that, The support frame has a proximal end and a distal end, and includes a first support frame and a second support frame; the first support frame is a closed structure and has a first proximal end face, a first distal end face and a first main body, the first main body being located between the first proximal end face and the first distal end face; The second support frame has a second proximal face and a second body, the second body extending from the second proximal face to the distal end; The first support frame and the second support frame are connected at the proximal end, and the first proximal end surface is in contact with the second proximal end surface; The first body has a first height, the second body has a second height, and the first height is greater than the second height.

2. The left atrial appendage occlusion device according to claim 1, characterized in that, The assembly includes a first assembly element for gathering the distal end of the first support frame without protruding beyond the contour of the first distal end surface. It also includes a second assembly element for converging the proximal end of the support frame; or, The second assembly element converges the proximal end of the first support frame, and the assembly further includes a third assembly element that converges the proximal end of the second support frame, with the second assembly element connected to the third assembly element.

3. The left atrial appendage occlusion device according to claim 2, characterized in that, The first support frame includes a first woven mesh, and the first woven mesh includes a plurality of first woven filaments; The second support frame includes at least one layer of second woven mesh, and the second woven mesh includes multiple second woven wires.

4. The left atrial appendage occlusion device according to claim 3, characterized in that, The number of the first braiding filaments is at least 72, the number of the second braiding filaments is at least 144, and the diameter of the second braiding filaments is 20%-60% of the diameter of the first braiding filaments.

5. The left atrial appendage occlusion device according to claim 3, characterized in that, The second support frame is disposed inside the first support frame, and the assembly further includes a fourth assembly element for converging the distal end of the second support frame; The second height is 20%-80% of the first height.

6. The left atrial appendage occlusion device according to claim 3, characterized in that, The second support frame is arranged outside the first support frame, and the second height is 20%-50% of the first height.

7. The left atrial appendage occlusion device according to any one of claims 3-6, characterized in that, The first woven mesh also includes multiple third braided wires, which together with the first braided wires form the first woven mesh; The diameter of the first braided filament is 20%-90% of the diameter of the third braided filament.

8. The left atrial appendage occlusion device according to claim 7, characterized in that, At least two microplanes are arranged on the third braided filament, and at least one anchoring structure is arranged on each microplane; a plurality of anchoring structures are distributed around the outer surface of the first body, and at least two anchoring zones are formed axially.

9. A left atrial appendage occlusion device assembly, characterized in that, Including the left atrial appendage occluder as described in any one of claims 1-8; It also includes a woven cover suitable for detachable connection to the proximal end of the left atrial appendage occluder.

10. A method for preparing a left atrial appendage occluder, characterized in that, Includes the following steps: S1, forging micro-planes on the third braiding filament to obtain the third braiding filament including multiple micro-planes, and the micro-planes having a fixed spacing between them; S2, the multiple micro-planes of the third braided filament are engraved to obtain the engraved part, and then the engraved part is heat-treated to shape it to form an anchoring structure located on the micro-plane; S3, weave multiple first braiding filaments with multiple third braiding filaments obtained in S2 to obtain a first braided web; weave multiple second braiding filaments to obtain a second braided web; S4, select the required length of the first woven mesh, use the first collection element to gather one end of the first woven mesh, flip the first woven mesh inside and out so that the first collection element is located inside the first woven mesh, and the anchoring structure is distributed on the outer surface of the first woven mesh; S5, select the required length of the second woven mesh, fold the second woven mesh in half so that the two ends of the second woven mesh overlap, and place the folded second woven mesh over or inside the first woven mesh so that the overlapping ends of the second woven mesh overlap with the untied end of the first woven mesh. Use the second gathering element to gather the overlapping ends of the first and second woven meshes; or Select the desired length of the second woven mesh, place the second woven mesh inside the first woven mesh, use the second gathering element to gather together the ungathered end of the first woven mesh and one end of the second woven mesh, and use the fourth gathering element to gather the other end of the second woven mesh; or Select the desired length of the second woven mesh, fold the second woven mesh in half so that its two ends overlap, use the third gathering element to gather the overlapping ends of the second woven mesh, use the second gathering element to gather the ungathered end of the first woven mesh, then slip the second woven mesh over the first woven mesh or place it inside the first woven mesh, and connect the second gathering element to the third gathering element; or Select the desired length of the second woven mesh, use the third gathering element to gather one end of the second woven mesh, use the fourth gathering element to gather the other end of the second woven mesh, use the second gathering element to gather the ungathered end of the first woven mesh, place the second woven mesh inside the first woven mesh, and connect the second gathering element to the third gathering element; S6, insert molds of corresponding specifications into the first woven mesh and the second woven mesh obtained in S5, and perform heat setting treatment on the first woven mesh and the second woven mesh to form a first support frame and a second support frame.

11. The method for preparing the left atrial appendage occluder according to claim 10, characterized in that, Step S1 also includes selecting the spacing between adjacent microplanes so that the spacing of the anchoring structure can be adapted to the different specifications of the left atrial appendage occluder.

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