An occluder and a method of manufacturing the same

Abstract

The present application relates to the technical field of implantable medical devices, and discloses a closure device, which comprises a sealing part, an anchoring part and a rigid connecting part; the rigid connecting part is arranged between the sealing part and the anchoring part and connects the two; wherein the outer surface of the rigid connecting part has a gradually expanding profile from the side adjacent to the sealing part to the side adjacent to the anchoring part, so as to reduce the jamming of a sheath tube at the connecting part of the sealing part and the anchoring part when the closure device is retrieved. The present application ensures that the anchoring part can smoothly and smoothly enter the delivery sheath tube by arranging a gradually expanding profile transition guide section at the rigid connecting part, avoids the jamming phenomenon, and significantly improves the safety and success rate of surgical operation.

Description

Technical Field

[0001] This invention relates to the field of implantable medical devices, specifically to an occluder and its manufacturing method. Background Technology

[0002] In percutaneous interventional procedures, to ensure precise positioning and release of implanted occluders (such as left atrial appendage occluders), intraoperative fine-tuning based on imaging assessments is often necessary. Therefore, retrieval and repositioning of the occluder become critical operational steps. Ensuring the successful retrieval of the occluder into the delivery sheath is a crucial prerequisite for safe and effective position adjustment. Summary of the Invention

[0003] This invention aims to at least solve one of the technical problems existing in the prior art. To this end, this invention proposes a plugging device and its preparation method, which can improve the smoothness of the plugging device entering the sheath.

[0004] The occluder provided by the present invention includes: a sealing part, an anchoring part, and a rigid connecting part; The rigid connection part is disposed between the sealing part and the anchoring part, and connects the two; The outer surface of the rigid connection has a profile that gradually widens from the side adjacent to the sealing part to the side adjacent to the anchoring part, in order to reduce the sheath from getting stuck at the connection between the sealing part and the anchoring part when the plug is retrieved.

[0005] Optionally, the expanding profile is a smoothly transitioning expanding profile.

[0006] Optionally, the rigid connection includes a tubular base, the widening profile is formed at the proximal end of the tubular base, and the anchoring portion is formed or connected at the distal end of the tubular base.

[0007] Optionally, the tubular substrate has an opening at its proximal end, through which the braided filaments forming the sealing portion are gathered and fixed to the tubular substrate.

[0008] Optionally, the proximal end of the tubular substrate has an arcuate or inclined surface extending outward from the opening to form the widening profile.

[0009] Optionally, The rigid connection includes a first tubular base and a second tubular base. The gradually widening profile is formed at the proximal end of the first tubular base, and the distal end of the first tubular base is embedded in the cavity of the second tubular base. The proximal end of the first tubular base smoothly transitions to the second tubular base through the gradually widening profile. The first tubular substrate is connected to the sealing portion at its proximal end, and the second tubular substrate is connected to the anchoring portion at its distal end.

[0010] Optionally, the first tubular substrate and the second tubular substrate are fixed by circumferential welding or adhesive bonding.

[0011] Optionally, the second tubular substrate and the anchoring portion are integrally cut from a tubular material.

[0012] Optionally, both the sealing portion and the anchoring portion are constructed from braided yarns, with one end of the braided yarn forming the sealing portion being tied within the first tubular matrix and one end of the braided yarn forming the anchoring portion being tied within the second tubular matrix.

[0013] Optionally, the first tubular matrix includes a cap forming its proximal end and a column forming its distal end; The gradually expanding contour is an arc-shaped surface or a slope formed on the outer surface of the cap; the braided threads forming the sealing part are bundled and fixed inside the cap; The distal end face of the cap abuts against the proximal end face of the second tubular base; The column extends axially from the distal end of the cap and is embedded in the cavity of the second tubular base.

[0014] Optionally, the diameter of the distal end of the cap is greater than or equal to the diameter of the proximal end of the second tubular base.

[0015] This application also provides a method for preparing the above-mentioned occluder, comprising: A rigid connection is formed, the rigid connection having a profile that gradually widens from the proximal end to the distal end in the axial direction, the distal end of which is integrally formed with or connected to the anchoring part. Connect the sealing portion to the proximal end of the rigid connection portion; The gradually widening profile is used to reduce the sticking of the sheath at the connection between the sealing part and the anchoring part when the plug is retrieved.

[0016] Optionally, forming a rigid connection portion specifically includes: A tubular base is provided as the rigid connection part; The gradually widening profile is formed at the proximal end of the tubular substrate; The anchoring portion is formed at the distal end of the tubular substrate.

[0017] Optionally, forming a rigid connection portion specifically includes: A first tubular matrix and a second tubular matrix are provided respectively; The gradually widening profile is formed at the proximal end of the first tubular substrate; The distal end of the first tubular substrate is embedded and fixed within the proximal cavity of the second tubular substrate; The distal end of the second tubular substrate is configured to be integrally formed with or connected to the anchoring portion.

[0018] The beneficial effects and advantages of the present invention will be set forth in the description which follows, will become apparent from the description, or may be learned by practice of the invention. Attached Figure Description

[0020] The present invention will be further described below with reference to the accompanying drawings and embodiments, wherein: Figure 1 This is a schematic diagram of the structure of an existing split-type plugging device; Figure 2 for Figure 1 A magnified view of a portion of the image; Figure 3 This is a schematic diagram of the insertion of an existing split-type plugging device; Figure 4 This is one of the structural schematic diagrams of the plugging device in an embodiment of the present invention; Figure 5 This is one of the structural schematic diagrams of the rigid connection part in an embodiment of the present invention; Figure 6 This is a second structural schematic diagram of the rigid connection part in an embodiment of the present invention; Figure 7 This is a second schematic diagram of the structure of the plugging device in an embodiment of the present invention; Figure 8 This is one of the structural schematic diagrams of the first tubular substrate in an embodiment of the present invention; Figure 9 This is a second schematic diagram of the structure of the first tubular substrate in an embodiment of the present invention; Figure 10 This is a schematic flowchart of the blocker preparation method in an embodiment of the present invention; Figure 11 This is one of the flowcharts illustrating the method for preparing a rigid connection in an embodiment of the present invention; Figure 12 This is a second schematic flowchart of the method for preparing the rigid connection part in an embodiment of the present invention.

[0021] Figure label: 1. Sealing part; 11. Distal end of sealing part; 2. Anchoring part; 3. Constraint sleeve; 4. Proximal end of metal fitting; 5. Step; 6. Sheath; 7. Rigid connection part; 71. Gradually widening profile; 72. First tubular base; 721. Cap; 722. Post; 723. Proximal end of cap; 724. Distal end face of cap; 73. Second tubular base. Detailed Implementation

[0022] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0023] In the description of this invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0024] In the description of this invention, "several" means one or more, "multiple" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0025] In the description of this invention, unless otherwise explicitly defined, terms such as "set up," "install," and "connect" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this invention in conjunction with the specific content of the technical solution.

[0026] In the description of this invention, the terms "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0027] See Figure 1 and Figure 2 A split-type occluder typically includes a sealing part 1 and an anchoring part 2, which are spaced apart along the axial direction of the occluder. Specifically, the sealing part 1 is located at the proximal end of the occluder, and the anchoring part 2 is located at the distal end. The anchoring part 2 is primarily used to enter the cavity to be occluded and anchor itself to the inner wall of the cavity. The sealing part 1 is primarily used for occlusion to seal the cavity. The cavities to be occluded include, but are not limited to, the left atrial appendage and aneurysms.

[0028] For example, taking a left atrial appendage occluder as an example, when the left atrial appendage occluder is implanted and released from the left atrial appendage, the anchoring part 2 is fully extended, including but not limited to being columnar or umbrella-shaped, so as to fit tightly against the cavity wall of the left atrial appendage, thereby facilitating the fixation of the occluder in the left atrial appendage and ensuring that the left atrial appendage occluder is effectively implanted in the left atrial appendage for a long time; the sealing part 1 is close to the opening or inner cavity of the left atrial appendage to block the left atrial appendage, prevent the thrombus formed in the left atrial appendage from flowing into the left atrium, and prevent the blood flow of the left atrium from flowing into the left atrial appendage.

[0029] For example, the anchoring part 2 may include multiple circumferentially arranged support rods, which may be integrally cut from a metal tube, or woven into a mesh structure by braided wires, and then heat-set after being closed by a proximal sleeve or other restraint. For example, anchor spikes may be provided on the anchoring part 2 to increase friction with the tissue or embed into the tissue after implantation at the anchoring site, thereby preventing device displacement and enhancing anchoring stability.

[0030] For example, the sealing part 1 can be woven from multiple braided filaments into a mesh tube. The far end and near end of the mesh tube can be closed and fixed by a sleeve or other constraint. Then the mesh tube is heat-formed into shapes including but not limited to disc, column, flat or plug.

[0031] For example, the braided wire is fixed in the sleeve 3 or other constraint by inserting the end of the braided wire into the sleeve 3 and welding or gluing it to the inner wall of the sleeve 3.

[0032] For anchoring frames where the anchoring part 2 is an integrally cut metal tube, the connection between the anchoring part 2 and the sealing part 1 typically involves embedding the constraint sleeve at the distal end of the sealing part 1 into the proximal end 4 of the metal tube in the anchoring part 2, and then welding or bonding the two together. For anchoring frames where the anchoring part 2 is a braided wire, the connection between the anchoring part 2 and the sealing part 1 typically involves embedding the constraint sleeve at the distal end of the sealing part 1 into the constraint sleeve at the proximal end of the anchoring part 2, and then welding or bonding the two together. The constraint sleeve at the distal end of the sealing part 1 and the proximal end of the metal tube in the anchoring part 2, and their connection, or the constraint sleeve at the distal end of the sealing part 1 and the constraint sleeve at the proximal end of the anchoring part 2, and their connection, form a rigid connection between the sealing part 1 and the anchoring part 2.

[0033] However, the aforementioned occluder has a problem: in clinical practice, for precise positioning and release, the occluder usually needs to be retrieved and repositioned. But during the sequential retrieval of the sealing part 1 and the anchoring part 2 from the sheath, jamming often occurs at the connection between the sealing part 1 and the rigid connection part. (See also...) Figure 1 and Figure 2The reason for this is that the aforementioned rigid connection is equivalent to having two layers of sleeves nested at the distal end of the sealing part 1 (the constraint sleeve at the distal end of the sealing part 1 and the constraint sleeve at the proximal end of the anchoring part 2, or the constraint sleeve 3 at the distal end of the sealing part 1 and the proximal end 4 of the metal tube of the anchoring part 2, with a thickness of h1+h2). See [link to relevant documentation]. Figure 3 A step 5 with a radial dimension abruptly changes is formed on the outer surface of the sealing part 11 to the rigid connection part. When the sheath tube 6 slides over this step 5 from the sealing part 1, especially when the sealing part 1 and the anchoring part 2 are not coaxial (due to the cavity to be sealed), the sheath tube is very likely to get stuck at this step 5, which will lead to a sharp increase in operating resistance, difficulty in positioning, and even the risk of damaging the cavity.

[0034] Therefore, the sealing device provided in this application embodiment has made structural improvements to the above-mentioned rigid connection part, aiming to eliminate the step and achieve a smooth transition.

[0035] See Figure 4 The plugging device provided in this application includes: a sealing part 1, an anchoring part 2, and a rigid connecting part 7 disposed between the sealing part 1 and the anchoring part 2 and connecting the two. The outer surface of the rigid connecting part 7 has a contour 71 that gradually widens from the side adjacent to the sealing part 1 to the side adjacent to the anchoring part 2, in order to reduce the jamming of the sheath at the connection between the sealing part 1 and the anchoring part 2 when the plugging device is retrieved.

[0036] The core concept of this application lies in improving the traditional rigid connection section, which creates a "right-angle step" due to the nesting of double-layered sheaths, into a guiding structure with a "gradually expanding profile." This gradually expanding profile forms a smooth and continuous transition area between the distal end of the sealing section 1 and the proximal end of the anchoring section 2. When the occluder is retracted into the sheath, this gradually expanding profile effectively guides the sheath to slide smoothly, avoiding jamming and improving the safety and reliability of the surgical procedure.

[0037] For example, see Figure 5 The gradually widening profile 71 is constructed as a smoothly transitioning profile. Here, "smooth transition" means that the profile has no abrupt changes or sharp angles in the axial direction, and its tangent changes are continuous, preferably achieving geometrical G2 continuity (curvature continuity). Furthermore, this profile can be a conical surface, a circular arc surface, an elliptical arc surface, or other continuous smooth curved surfaces. By employing a smoothly transitioning gradually widening profile, local stress concentration and frictional resistance during sheath sliding can be minimized, ensuring a smooth guiding process.

[0038] It should be noted that the "gradually expanding profile 71" described in the embodiments of this application refers to the macroscopic geometric feature of the outer surface of the rigid connection portion, which, when viewed axially from the side adjacent to the sealing portion 1 towards the side adjacent to the anchoring portion 2, shows a general increasing trend in profile. This "gradual expansion" characteristic is intended to achieve a smooth transition guiding function and does not require the profile to be strictly monotonically increasing. In some preferred embodiments, the "gradually expanding profile 71" is monotonically increasing, that is, the "gradual expansion" is monotonic (the profile size continuously increases along the axial direction), see [reference]. Figure 5 In other embodiments, when viewed axially from the side adjacent to the seal 1 towards the side adjacent to the anchor 2, the "widening profile 71" may have undulations, see [reference needed]. Figure 6 That is, the gradual expansion is not monotonous. From a macroscopic perspective, there may be slight undulations or changes in the local areas of the outline (the outline size may increase or decrease along the axial direction), but overall, a smooth transition from a smaller outline to a larger outline can be achieved, which falls within the protection scope of this application.

[0039] Based on the above core concept, this application also provides a corresponding method for preparing the occluder. See [link to relevant documentation]. Figure 10 The method includes: Step 1: Form a rigid connection portion having a profile 71 that gradually widens axially from its proximal end to its distal end, and its distal end is configured to be integrally formed with or connected to the anchoring portion 2.

[0040] Step 2: Connect the sealing portion 1 to the proximal end of the rigid connection portion. In the final manufactured plug, the expanding profile 71 is configured to reduce sheath jamming at the connection between the sealing portion 1 and the anchoring portion 2 during retrieval operations.

[0041] It should be noted that the above method steps (steps 1 and 2) mainly describe the key technological processes involved in realizing the plugging device structure of this application. In actual production practice, the execution order of each step is not fixed, and it depends on the selected structural form of the rigid connection part and the corresponding manufacturing process path. It is understood that there can be many structural forms of the rigid connection part. For example, two different structural forms of the rigid connection part are introduced in Embodiments 1 and 2 below. This application does not limit the specific execution order between the two key technological steps of "forming the rigid connection part" and "connecting the sealing part 1". Any reasonable process sequence that can produce the plugging device as described in the embodiments of this application should be included within the protection scope of the method claims of this application.

[0042] Example 1

[0043] See Figure 5The rigid connection includes a tubular base with a gradually widening profile 71 formed at its proximal end. The distal end of the tubular base is integrally formed or fixedly connected to the anchoring portion 2. Exemplarily, the anchoring portion 2 can be formed by laser cutting and shaping the distal end of the tubular base to create a support frame, thereby forming an anchoring portion 2 integral with the rigid connection. Exemplarily, the anchoring portion 2 can also be a frame structure composed of an independent braided structure or a combination of support rods, with its proximal end fixed to the distal end of the tubular base by welding or other means.

[0044] Furthermore, the proximal end of the tubular substrate has an opening. The braided filaments forming the sealing portion 1 are bundled through the opening and extend into the inner cavity of the tubular substrate. The ends of the braided filaments can be fixed to the tubular substrate by welding, gluing, or other methods, thereby achieving a reliable connection between the sealing portion 1 and the rigid connection portion. It is understood that the opening is axial, that is, at least the portion of the tubular substrate at the proximal end used to connect the braided filaments of the sealing portion is hollow.

[0045] Furthermore, to achieve the gradually widening profile 71, the proximal end of the tubular substrate is machined into a specific shape extending outward from the opening. Specifically, its proximal outer surface is constructed as an arcuate surface or a slope. The outer diameter of this arcuate surface or slope gradually increases axially towards the distal end from a dimension smaller than the outer diameter of the main body of the tubular substrate, eventually smoothly transitioning to the outer diameter of the main body of the tubular substrate. This structure creates a smooth, stepless transition zone between the braided yarn convergence point of the sealing portion 1 and the outer surface of the rigid connection portion.

[0046] The integrated design of this embodiment simplifies the number of components and results in a compact structure. By directly machining a gradually widening arc-shaped surface or bevel near the proximal end of the tubular base of the anchoring part 2, the radial dimension abrupt change caused by the nested double-layer sleeve in the traditional structure is eliminated, effectively reducing the risk of retrieval jamming.

[0047] Based on the rigid connection portion of this embodiment, see [link / reference]. Figure 11 Step 1 in the above embodiment further includes the following steps: Step 11a: Provide a tubular substrate as the rigid connection part.

[0048] Step 12a: The gradually widening profile 71 is formed at the proximal end of the tubular substrate.

[0049] Step 13a: The anchoring portion is formed at the distal end of the tubular substrate.

[0050] There is no restriction on the order of steps 12a and 13a.

[0051] Specifically, during preparation, a metal tube can be provided as a tubular base. Then, the proximal end of the tubular base is machined (e.g., precision turning, grinding) or plastic forming to form the gradually expanding profile described in the previous embodiment. That is, the outer diameter of the proximal end of the tubular base gradually increases axially from the proximal end to the distal end, eventually smoothly transitioning to the outer diameter of the main body of the tubular base. The braided wires of the sealing part 1 are bundled and fixed within the inner cavity of the proximal end of the tubular base, creating a smooth, stepless transition zone between the bundled end of the braided wires of the sealing part 1 and the outer surface of the rigid connection part.

[0052] For example, the expanding profile can be an arc-shaped surface or an inclined surface. Specifically, it can be a conical surface formed by rotating a straight line around a fixed axis that intersects it, or an arc-shaped conical surface formed by rotating an arc around a fixed axis that intersects it. For example, the curvature of the arc can change in a certain regular pattern. For instance, the curvature can be designed along the axial direction as a "gradual-rapid-gradual" change pattern: in the initial part (i.e., at the connecting sealing part 1), a larger radius of curvature (i.e., a smaller curvature) is used to reduce the cutting resistance when the sheath opening initially contacts the guide structure; in the middle part, the radius of curvature decreases (curvature increases) to guide the movement of the sheath quickly and effectively within a limited axial length; in the final section, the radius of curvature increases again to make its profile transition smoothly.

[0053] The distal end of the tubular substrate can be processed into an anchoring part 2 structure by cutting (such as laser cutting) or engraving, according to the design, or connected to an independent anchoring part 2 component.

[0054] For example, "the braided filaments of the sealing part 1 are bundled and fixed in the inner cavity of the proximal end of the tubular base" can specifically mean that the end of the braided filaments is bundled and fixed in a sleeve, the sleeve is embedded in the inner cavity of the proximal end of the tubular base, and extends a certain distance into the inner cavity to separate it from the section where the gradually expanding contour is located, so as to avoid affecting the forming of the gradually expanding contour. In this case, it is necessary to first connect the bundled sleeve to the proximal end of the tubular base, that is, to perform step 2 first, and then perform step 12a. It can be understood that the size of the braided filaments after bundling is smaller than the contour size of the tubular base. In order to avoid creating a step from the braided filament bundling point to the transition position of the tubular base, the gradually expanding contour of the proximal end of the tubular base plays the role of eliminating the step and smoothly guiding the transition.

[0055] For example, "the braided filaments of the sealing part 1 are bundled and fixed in the inner cavity of the proximal end of the tubular base." Specifically, step 12a can be performed first to process the gradually expanding contour 71 at the proximal end of the tubular base, with the radial dimension of the narrow end being close to the radial dimension of the bundled end of the braided filaments of the sealing part 1. Then, the bundled end of the braided filaments is directly inserted into the narrow end and fixed to the narrow end by welding or gluing. That is, a sleeve for bundling the end of the braided filaments of the sealing part is no longer provided separately; instead, the end of the braided filaments of the sealing part is directly bundled and fixed to the narrow end of the tubular base. It can be understood that the tubular base has a relatively small narrow end and a relatively large wide end in the axial direction of the gradually expanding contour section, which can also be referred to as the proximal end and distal end of the gradually expanding contour, respectively.

[0056] Example 2

[0057] like Figure 7 As shown, the rigid connection portion 7 includes a first tubular base 72 and a second tubular base 73. A gradually widening profile 71 is formed on the proximal outer surface of the first tubular base 72. The distal end of the first tubular base 72 is embedded in the proximal cavity of the second tubular base 73 and is fixedly connected to the second tubular base 73 by means of, for example, circumferential welding or adhesive application, so that the proximal end of the first tubular base 72 smoothly transitions to the outer surface of the second tubular base 73 through the gradually widening profile of its outer surface. The first tubular base 72 is connected to a sealing portion 1 on its proximal side, and the distal end of the second tubular base 73 is connected to an anchoring portion 2.

[0058] The connection relationship between the second tubular base 73 and the anchoring part 2 can be selected according to design requirements. In some embodiments, the second tubular base 73 and the anchoring part 2 can be integrally cut from the same section of metal tubing using processes such as laser cutting. In this way, the distal end of the second tubular base 73 naturally extends and forms the proximal connection base of the anchoring part 2, without the need for additional connection steps, and with strong integrity. In other embodiments, the anchoring part 2 can also be constructed by braiding wires, with one end of the braided wires forming the anchoring part 2 being gathered and fixed to the distal end of the second tubular base 73.

[0059] The sealing part 1 can typically be made of braided filaments, with one end of the braided filaments forming the sealing part 1 being bundled and fixed to the proximal end of the first tubular base 72.

[0060] In some specific embodiments, the first tubular substrate 72 and the second tubular substrate 73 may be circumferentially welded or glued at their joint after assembly to ensure a firm and reliable connection with good sealing performance.

[0061] For details, see Figure 8The first tubular base 72 includes a cap 721 and a post 722. The radial dimension of the cap 721 is larger than that of the post 722. The cap 721 forms the proximal end of the first tubular base, and its outer surface forms a gradually widening profile 71, which can be an arc-shaped surface or a slope. The braided filaments forming the sealing portion are bundled and fixed inside the cap 721, for example, by welding or gluing, into the opening of the proximal end 723 of the cap. The post 722 extends axially from the distal end of the cap 721 and is embedded as a connecting portion into the proximal cavity of the second tubular base 73. The distal end face 724 of the cap abuts against the proximal end face of the second tubular base 73, that is, the cap 721 and the post 722 form a stepped shape, and the stepped surface abuts against the proximal end face of the second tubular base 73.

[0062] Understandably, the opening of the near end 723 of the cap is axial, meaning that at least the portion of the first tubular base 72 used to connect the braided threads of the sealing part is hollow.

[0063] For example, such as Figure 5 The diameter of the distal end of the cap 721 can be equal to the diameter of the proximal end of the second tubular base 73. In this case, the expanding profile of the outer surface of the cap 721 transitions continuously and steplessly from its smaller radial dimension at its proximal end (where it connects to the sealing part 1) to its distal end, achieving geometric continuity between the expanding profile of the cap 721 and the outer circumferential surface of the second tubular base 73 at the joint. During the retrieval operation, the sheath opening moves along this path without encountering any abrupt changes in radial dimension, thus achieving smooth movement guidance from the sealing part 1 to the anchoring part 2 and eliminating the risk of jamming.

[0064] For example, such as Figure 6 The diameter of the distal end of the cap 721 can also be larger than the diameter of the proximal end of the second tubular base 73. During the retraction of the plug into the sheath, the sheath moves from the anchoring part 2 toward the sealing part 1. In this direction of movement, as long as the radial dimension of the profile does not suddenly increase, there is no risk of jamming due to abrupt changes in the profile; and a decrease in the radial dimension of the profile will not hinder the smooth passage of the sheath. Based on this, it is not necessary to require that the radial dimensions of the distal end of the cap 721 and the proximal end of the second tubular base 73 be strictly consistent. Designing the radial dimension of the distal end face of the cap 721 to be larger than the radial dimension of the proximal end face of the second tubular base 73, while ensuring the guiding function, provides a larger tolerance range for the machining of the cap 721 structure, which can reduce the machining accuracy requirements and manufacturing costs to a certain extent.

[0065] Based on the rigid connection portion of this embodiment, see [link / reference]. Figure 12 Step 1 in the above embodiment further includes the following steps: Step 11b: Provide a first tubular substrate 72 and a second tubular substrate 73 respectively.

[0066] Step 12b: The widening profile 71 is formed at the proximal end of the first tubular substrate 72.

[0067] Step 13b: Embed and fix the distal end of the first tubular base 72 into the proximal cavity of the second tubular base 73; wherein the distal end of the second tubular base 73 is configured to be integrally formed with or connected to the anchoring part 2.

[0068] Specifically, the widening profile 71 is formed on the proximal outer surface of the first tubular substrate 72. In actual manufacturing, an arc-shaped surface or a bevel can be machined at the proximal end of the first tubular substrate 72 through precision turning, grinding, or forming processes to form the widening profile.

[0069] For example, the arcuate surface or inclined surface, specifically, can be a conical surface formed by rotating a straight line about a fixed axis that intersects it, see [reference needed]. Figure 9 Or, an arc-shaped conical surface formed by rotating an arc about a fixed axis that intersects it, see... Figure 8 For example, the curvature of the arc can change in a certain regular pattern. For instance, the curvature can be designed along the axial direction as a "gradual-rapid-gradual" change pattern: at the beginning (i.e., at the connecting sealing part 1), a larger radius of curvature (i.e., a smaller curvature) is used to reduce the cutting resistance when the sheath opening initially contacts the guide structure; in the middle part, the radius of curvature decreases (curvature increases) to guide the sheath movement quickly and effectively within a limited axial length; at the end, the radius of curvature increases again to make its contour transition smoothly.

[0070] Furthermore, the first tubular substrate 72 can be fabricated as a structure including a cap portion 721 and a pillar portion 722. The radial dimension of the cap portion 721 is larger than that of the pillar portion 722. The cap portion 721 forms the proximal end of the first tubular substrate 72, and its outer surface has a gradually widening profile. The proximal end of the cap portion 721 has an opening, allowing the braided filaments forming the sealing portion 1 to be bundled and fixed within the cap portion 721, for example, by welding or gluing, into the proximal cavity of the cap portion 721. The pillar portion 722 extends axially from the distal end of the cap portion 721.

[0071] Exemplarily, in some embodiments, the first tubular substrate 72 can be prepared using a powder injection molding process. Specifically, fine metal powder is mixed with a binder to form a feedstock, which is then injected into a precision mold cavity using an injection molding machine to obtain a green body with a complex shape. After the green body is degreased to remove the binder, it is sintered at a high temperature to finally form the first tubular substrate. In other embodiments, the first tubular substrate can also be formed using precision machining methods such as computer numerical control based on metal (e.g., nickel-titanium alloy, stainless steel, cobalt-chromium alloy, or platinum-chromium alloy) rods or tubes. First, the metal rod or tube is fixed on a CNC machine tool, and according to a preset digital three-dimensional model, excess material is gradually removed under program control using precision turning, milling, or grinding processes to integrally mold the connector with high precision. The embodiments of this application do not limit the preparation process of the first tubular substrate, as long as the desired structure can be obtained.

[0072] It should be noted that, regardless of the processing method used, the first tubular substrate usually needs to undergo subsequent finishing processes, such as electropolishing, mechanical polishing, or vibratory polishing, to remove surface burrs and microscopic defects, obtain a smooth surface that meets the requirements of implantable devices, further reduce frictional resistance with the delivery sheath, and improve its corrosion resistance and biocompatibility.

[0073] The second tubular base 73 is mainly used for connection with the anchoring part 2. In some embodiments, the second tubular base 73 and the anchoring part 2 can be integrally cut from the same section of metal tubing using processes such as laser cutting. In this way, while the second tubular base 73 is being prepared, its distal end naturally extends and forms the proximal connection base of the anchoring part 2, achieving integral molding. In other embodiments, the anchoring part 2 can also be an independent braided structure or support frame, in which case the distal end of the second tubular base 73 is connected to the anchoring part 2 by welding or other methods.

[0074] The key assembly step involves embedding the distal end (i.e., the column portion 722) of the first tubular base 72 into the proximal cavity of the second tubular base 73, with the distal end face of the cap portion 721 abutting against the proximal end face of the second tubular base 73. Specifically, the stepped surface formed by the cap portion 721 and the column portion 722 abuts against the proximal end face of the second tubular base 73. Then, the distal end (i.e., the column portion 722) of the first tubular base 72 is fixedly connected to the proximal inner wall of the second tubular base 73 by means such as circumferential welding or adhesive application. This step allows the proximal end of the first tubular base 72 to smoothly transition to the outer surface of the second tubular base 73 through its gradually expanding outer contour. Subsequently, the sealing portion 1 is connected to the proximal end of the first tubular base 72 (cap portion 721), thereby completing the overall assembly of the occluder.

[0075] Example 1 involves two distinct precision machining processes performed sequentially or alternately on the same tubular substrate: turning or grinding to form a gradually expanding profile at the near end, and laser engraving to cut and form the anchoring part 2 frame at the far end. These two processes have different requirements for clamping, heat input, and cutting forces, making them highly susceptible to interference. For example, the heat effect of the laser cutting at the far end may alter the dimensional accuracy or material properties of the already formed gradually expanding profile at the near end; conversely, protecting the completed gradually expanding profile may limit the parameter selection for the far-end cutting process, affecting the forming efficiency of the anchoring part 2. Example 2 completely avoids these process conflicts. The task of forming the gradually expanding profile is independently assigned to the first tubular substrate 72, allowing for focused machining without considering the influence of the far-end process. Simultaneously, the task of connecting or forming the anchoring part 2 is assigned to the second tubular substrate 73, allowing for independent cutting, engraving, or connection with other components. This process separation allows each component to be manufactured under its most suitable processing conditions, resulting in easier, more precise, and more controllable processing yields. It also reduces reliance on single, complex composite processing equipment, thereby significantly improving manufacturing feasibility and economy while ensuring consistent product performance. Therefore, Example 2 is a more preferred embodiment of this application.

[0076] Exemplarily, in all the above embodiments, after the braided filaments forming the sealing portion 1 are bundled, their bundled ends occupy a certain radial space, which can be defined as the braided filament bundled size. To achieve a smooth transition from the sealing portion 1 to the rigid connection portion, the radial dimension of the expanding profile at its starting point (i.e., the position adjacent to the bundled end of the sealing portion 1) is designed to match the braided filament bundled size. Specifically, the wall thickness of the tubular substrate at this starting point can be designed to be relatively thin so that its outer contour is as close as possible to the internal braided filament bundle. Exemplarily, the wall thickness here can be between 0.2 mm and 0.5 mm, thereby minimizing the radial dimension jump from the braided filament bundled end to the starting point of the expanding profile, while allowing for structural strength, further optimizing the smoothness of the transition.

[0077] It should be noted that, in the embodiments of this application, the term "bundling" is used to describe the processing state of the braided filaments forming the sealing or anchoring portion at their ends. Specifically, after the braided filaments are gathered, their ends exhibit a physical state where the filament bundles are tightly aggregated and the radial dimensions are constrained. It can be understood that the outer contour of the braided filament ends in this "bundling" state has a defined dimension in the radial direction.

[0078] This embodiment of the application, by setting the gradually expanding profile, constructs an effective transition zone between the sealing part 1 and the second tubular base 73 (or the tube body of the anchoring part 2). Therefore, when designing the product, the radial dimension of the second tubular base 73 is mainly selected based on practical factors such as its structural strength, connection requirements with the anchoring part 2, and the overall device profile, without having to deliberately limit its size to avoid the risk of jamming, as is the case with traditional structures. This provides greater flexibility and optimization space for the structural design of the second tubular base 73 and even the entire anchoring part 2.

[0079] This embodiment of the application ensures that the anchoring part can smoothly and easily enter the delivery sheath by setting a gradually expanding contour transition guide section at the rigid connection, avoiding jamming and significantly improving the safety and success rate of the surgical operation.

[0080] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments, and various changes can be made within the scope of knowledge possessed by those skilled in the art without departing from the spirit of the present invention. Furthermore, the embodiments of the present invention and the features thereof can be combined with each other unless otherwise specified.

Claims

1. A sealing device, characterized in that, include: Sealing part, anchoring part, and rigid connection part; The rigid connection part is disposed between the sealing part and the anchoring part, and connects the two; The outer surface of the rigid connection has a profile that gradually widens from the side adjacent to the sealing part to the side adjacent to the anchoring part, in order to reduce the sheath from getting stuck at the connection between the sealing part and the anchoring part when the plug is retrieved.

2. The occluder according to claim 1, characterized in that, The expanding contour is a smoothly transitioning expanding contour.

3. The occluder according to claim 1 or 2, characterized in that, The rigid connection includes a tubular base, the widening profile being formed at the proximal end of the tubular base, and the anchoring portion being formed or connected at the distal end of the tubular base.

4. The occluder according to claim 3, characterized in that, The tubular substrate has an opening at its proximal end, through which the braided filaments forming the sealing portion are gathered and fixed to the tubular substrate.

5. The plugging device according to claim 4, characterized in that, The proximal end of the tubular substrate has an arcuate or inclined surface extending outward from the opening, forming the gradually widening profile.

6. The plugging device according to claim 1 or 2, characterized in that, The rigid connection includes a first tubular base and a second tubular base. The gradually widening profile is formed at the proximal end of the first tubular base, and the distal end of the first tubular base is embedded in the cavity of the second tubular base. The proximal end of the first tubular base smoothly transitions to the second tubular base through the gradually widening profile. The first tubular substrate is connected to the sealing portion at its proximal end, and the second tubular substrate is connected to the anchoring portion at its distal end.

7. The occluder according to claim 6, characterized in that, The first tubular substrate and the second tubular substrate are fixed by circumferential welding or adhesive bonding.

8. The occluder according to claim 6, characterized in that, The second tubular base and the anchoring part are integrally cut from the tubing.

9. The occluder according to claim 6, characterized in that, Both the sealing part and the anchoring part are made of braided yarn, and one end of the braided yarn forming the sealing part is tied into the first tubular matrix, and one end of the braided yarn forming the anchoring part is tied into the second tubular matrix.

10. The occluder according to claim 6, characterized in that, The first tubular matrix includes a cap forming its proximal end and a column forming its distal end; The gradually expanding contour is an arc-shaped surface or a slope formed on the outer surface of the cap; the braided threads forming the sealing part are bundled and fixed inside the cap; The distal end face of the cap abuts against the proximal end face of the second tubular base; The column extends axially from the distal end of the cap and is embedded in the cavity of the second tubular base.

11. The occluder according to claim 10, characterized in that, The diameter of the distal end of the cap is greater than or equal to the diameter of the proximal end of the second tubular base.

12. A method for preparing a plugging device according to any one of claims 1-11, characterized in that, include: A rigid connection is formed, the rigid connection having a profile that gradually widens from the proximal end to the distal end in the axial direction, the distal end of which is integrally formed with or connected to the anchoring part. Connect the sealing portion to the proximal end of the rigid connection portion; The gradually widening profile is used to reduce the sticking of the sheath at the connection between the sealing part and the anchoring part when the plug is retrieved.

13. The method for preparing the occluder according to claim 12, characterized in that, The formation of a rigid connection specifically includes: A tubular base is provided as the rigid connection part; The gradually widening profile is formed at the proximal end of the tubular substrate; The anchoring portion is formed at the distal end of the tubular substrate.

14. The method for preparing the plugging device according to claim 12, characterized in that, The formation of a rigid connection specifically includes: A first tubular matrix and a second tubular matrix are provided respectively; The gradually widening profile is formed at the proximal end of the first tubular substrate; The distal end of the first tubular substrate is embedded and fixed within the proximal cavity of the second tubular substrate; The distal end of the second tubular substrate is configured to be integrally formed with or connected to the anchoring portion.

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