Plugging device weaving mold, shaping mold, manufacturing method and plugging device

Abstract

The invention relates to a knitting mold, a shaping mold and a manufacturing method of a plugging device and the plugging device. By utilizing the knitting mold, a puncture channel can be reserved on a disc surface of the finally-formed plugging device, and in order to enhance the stability of a puncture channel structure, side holes can also be formed in the side surface of a woven mesh; the side holes can correspond to the puncture channel after the woven mesh is thermally formed into the plugging device, so that the structure of the puncture channel is better maintained, and the puncture channel is prevented from being recovered or reduced in size due to stress; and the channel forming die in the shaping die can penetrate into the puncture channel and limit the puncture channel, so that final shaping is facilitated.

Description

Technical Field

[0001] The present invention relates to the field of medical devices for interventional procedures, and in particular to an occluder weaving mold, a shaping mold, a manufacturing method and an occluder. Background Art

[0002] Atrial septal defect and patent foramen ovale are common congenital heart diseases. As these patients age, the incidence of atrial fibrillation, mitral regurgitation and other diseases will be much higher than that of ordinary people. The current clinically mature treatments for these diseases include minimally invasive interventional surgeries such as radiofrequency ablation, left atrial appendage closure and mitral valve treatment. However, the pathway from the right atrium to the left atrium is an important channel for interventional surgeries such as radiofrequency ablation, left atrial appendage closure, mitral valve replacement, and mitral valve repair. The mainstream occluders currently on the market are permanently implanted and are mainly made of densely woven nickel-titanium alloy wire mesh. Therefore, after the occlusion, the left and right atria will be isolated by 2-4 layers of densely woven metal mesh, making it difficult to re-establish the pathway from the right atrium to the left atrium. Summary of the invention

[0003] The invention discloses an occluder braiding mold, a shaping mold, a manufacturing method and an occluder, aiming to solve the technical problems existing in the prior art.

[0004] The present invention adopts the following technical solutions:

[0005] In a first aspect, an embodiment of the present invention provides an occluder braiding mold, comprising a braiding mold body, used to braid an elastic braiding frame of the occluder, wherein the braiding mold body is in the shape of an elongated cylinder, and has a circumferential side surface and a top surface and a bottom surface at both ends of the axial direction;

[0006] The circumferential side surface is provided with a plurality of longitudinally extending grooves;

[0007] The top surface is provided with a braiding column for mounting the braided wire. The braiding column is provided with several steps from the outside to the inside along the radial direction of the top surface. The braiding columns of each step are arranged along the circumferential direction. A channel forming column is also provided between the first and last braiding columns, which is used to reserve a puncture channel on the elastic braided grid.

[0008] The bottom surface is also provided with weaving columns and channel forming columns, and the distribution of the two on the bottom surface is the same as that on the top surface.

[0009] As a preferred technical solution, the braided column is provided with 1-n steps from the outside to the inside, n>2, the nth step is provided near the center of the top surface, and the channel forming column is provided between the 1st step and the nth step;

[0010] There is one channel forming column, or there are multiple channel forming columns along the circumferential direction.

[0011] As a preferred technical solution, a track limiting column is provided on the circumferential side surface to guide the braiding wire to form side holes when it is wound and braided along the circumferential side surface.

[0012] In a second aspect, an embodiment of the present invention provides an occluder shaping mold, which is used to heat-shape the elastic braided mesh woven by the above-mentioned occluder braiding mold into an occluder body, and the occluder shaping mold includes a fixing component, a molding component and a locking component;

[0013] The fixing assembly includes a mold fixing top plate and a mold fixing bottom plate, the molding assembly is arranged between the mold fixing top plate and the mold fixing bottom plate, and the fixing assembly is used to axially clamp and fix the molding assembly; a plurality of columns are arranged below the mold fixing top plate, and the columns correspond to the braided wires;

[0014] The locking assembly is used for axially locking the fixing assembly;

[0015] The molding component is used to shape the elastic woven mesh into an occluder, and the molding component includes a top mold, a bottom mold, a channel molding mold, a left disk inner mold, a right disk inner mold, a waist inner mold, and a waist outer mold; the channel molding mold is axially arranged and passes through the top mold and the bottom mold, and is used to shape the puncture channel reserved on the disk surface of the occluder; the top mold is provided with a plurality of through holes for the columns and the channel molding mold to pass through.

[0016] As a preferred technical solution, the diameter of the channel forming die is larger than the diameter of the column;

[0017] There is one channel forming die, or there are multiple channel forming dies along the circumferential direction.

[0018] In a third aspect, an embodiment of the present invention provides a method for manufacturing an occluder, comprising a weaving step and a heat setting step;

[0019] The braiding step is implemented based on the occluder braiding mold as described in any one of the above items, and includes:

[0020] The braiding wire is spirally wound upward along the circumferential side surface starting from the bottom surface of the braiding mold body, and then, after reaching the top surface, it is wound around the braiding column and spirally wound downward along the circumferential side surface in the reverse direction to complete the braiding of a single braiding wire;

[0021] Repeat the above steps until the winding of the first-order braided column is completed;

[0022] Weaving in order from outside to inside, the braided wires bypass the channel forming column to reserve a puncture channel, the size of the puncture channel is larger than the size of the braided mesh, until all the braided wires are woven to obtain a braided net, and all the braided wires in the braided net are woven with the same material;

[0023] Pre-shaping and closing the woven mesh to obtain an elastic woven mesh frame;

[0024] The heat setting step is implemented based on the occluder setting mold as described in any one of the above items, and includes:

[0025] The elastic braided mesh frame is placed into the forming component, and the channel forming mold is inserted into the puncture channel and limited;

[0026] The forming component and the elastic braided mesh frame are locked by the fixing component and the locking component, and heated to be formed, so as to obtain an occluder body having a left disk surface, a right disk surface, a waist and a puncture channel;

[0027] The blocking membrane is sewn to obtain the occluder.

[0028] As a preferred technical solution, the weaving step further includes:

[0029] Using the occluder braiding mold as described above to wrap the braided wire;

[0030] The braiding wires bypass the track limiting posts when braiding and winding along the circumferential side of the braiding mold body until all the braiding wires are braided to obtain a braided mesh with side holes;

[0031] The size of the side hole obtained by weaving is larger than the size of the puncture channel, and the side hole can correspond to the puncture channel after the step of heat setting the elastic woven mesh frame.

[0032] As a preferred technical solution, the weaving step further includes:

[0033] The braiding wires bypass the track limiting pillars when braiding and winding along the circumferential side of the braiding mold body until all the braiding wires are braided to obtain a braided mesh with side holes, and the side holes are sequentially arranged on the disk surface positions after the elastic braiding mesh frame is heat-set;

[0034] The side holes arranged on the disk surface can correspond one-to-one with the puncture channels after the elastic braided mesh frame is heat-set.

[0035] In a fourth aspect, an embodiment of the present invention provides an occluder, which is prepared based on the occluder manufacturing method as described in any one of the above items, and is characterized by comprising:

[0036] - The main body of the occluder is a heat-set elastic woven mesh frame, including a left disk, a waist and a right disk;

[0037] At least a puncture channel is provided on the right disk surface, and the size of the puncture channel is larger than the mesh size of the elastic woven mesh frame;

[0038] - Flow-blocking membrane, including left disk flow-blocking membrane, right disk flow-blocking membrane and waist flow-blocking membrane;

[0039] The left disc flow-blocking film is arranged in the left disc surface, the right disc flow-blocking film is arranged in the right disc surface, and the waist flow-blocking film is arranged at the waist.

[0040] As a preferred technical solution, puncture channels are provided on the left disk surface, the right disk surface and the waist.

[0041] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0042] (1) On one hand, the present invention provides a braiding mold and a shaping mold for an occluder, which correspond to the braiding process and the heat setting process of the occluder, respectively. A channel forming column is arranged on the top of the braiding mold. When the braiding wire is wound and braided, it bypasses the channel forming column for braiding, so that a puncture channel can be reserved on the disk of the finally formed occluder. In order to enhance the stability of the puncture channel structure, side holes can be arranged on the side of the braided mesh. After the braided mesh is heat-formed into the occluder, the side holes can correspond to the puncture channel to better maintain the structure of the puncture channel and avoid the puncture channel from recovering or shrinking in size due to stress. In order to further stabilize the structure of the puncture channel during heat setting, a channel shaping mold is also arranged in the shaping mold, which can penetrate into the puncture channel and limit it to facilitate the final shaping.

[0043] (2) On the other hand, the present invention provides a method for manufacturing an occluder and an occluder manufactured using the method. The manufacturing method is implemented based on the above-mentioned weaving mold and shaping mold. The occluder manufactured based on the method not only does not cause galvanic corrosion, but also reserves a puncture channel to provide patients with the opportunity for further interventional treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions explain the present invention and do not constitute improper limitations on the present invention. In the drawings:

[0045] Figure 1 It is a structural schematic diagram of an occluder braiding mold disclosed in a preferred implementation manner of Example 1 of the present invention;

[0046] Figure 2 It is a structural schematic diagram of an occluder shaping mold disclosed in a preferred implementation manner of Example 2 of the present invention;

[0047] Figure 3 This is a diagram showing the use status of the occluder shaping mold disclosed in a preferred implementation manner of Example 2 of the present invention;

[0048] Figure 4 A diagram showing the occluder shaping mold in use at another angle according to a preferred implementation manner of Example 2 of the present invention;

[0049] Figure 5 This is a step diagram of a method for manufacturing an occluder disclosed in a preferred implementation manner of Example 3 of the present invention;

[0050] Figure 6 A schematic diagram of the top surface of a braiding mold body disclosed in a preferred implementation manner of Example 3 of the present invention;

[0051] Figure 7 — Fig. 9 A schematic diagram of the first-order braiding step disclosed in a preferred implementation manner of Example 3 of the present invention;

[0052] Fig.10 A schematic diagram of a first-stage weaving method disclosed in a preferred implementation manner of Example 3 of the present invention;

[0053] Fig.11 A schematic diagram of a second-stage braiding method disclosed in a preferred implementation manner of Example 3 of the present invention;

[0054] Fig.12 A schematic diagram of a third-order braiding method disclosed in a preferred implementation manner of Example 3 of the present invention;

[0055] Fig.13 A schematic diagram of a fourth-order braiding method disclosed in a preferred implementation manner of Example 3 of the present invention;

[0056] Fig.14 A schematic diagram of the top surface structure of the braided mesh disclosed in a preferred implementation manner of Example 3 of the present invention;

[0057] Fig.15 This is a schematic diagram of a woven mesh structure with side holes disclosed in a preferred implementation manner of Example 3 of the present invention;

[0058] Fig.16 This is a schematic diagram of the structure of a woven mesh with side holes disclosed in another preferred embodiment of Example 3 of the present invention;

[0059] Fig.17 It is a schematic structural diagram of a PFO occluder disclosed in a preferred implementation manner of Example 4 of the present invention;

[0060] Fig.18 A front view of a PFO occluder disclosed in a preferred embodiment of Example 4 of the present invention;

[0061] Fig.19 It is a schematic structural diagram of an ASD occluder disclosed in a preferred implementation manner of Example 4 of the present invention;

[0062] Fig. 20 This is a front view of an ASD occluder disclosed in a preferred implementation manner of Example 4 of the present invention.

[0063] Description of reference numerals:

[0064] Weaving mold body 100, groove 110, weaving column 120, channel forming column 130;

[0065] Occluder shaping mold 200, fixing assembly 210, mold fixing top plate 211, mold fixing bottom plate 212, locking assembly 220, screw 221, nut 222, forming assembly 230, top mold 231, bottom mold 232, channel forming mold 233, left plate inner mold 234, right plate inner mold 235, waist inner mold 236, waist outer mold 237;

[0066] Braided wire 300, side hole 301;

[0067] The occluder body 400 , the left disk surface 410 , the right disk surface 420 , and the waist portion 430 . DETAILED DESCRIPTION

[0068] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise.

[0069] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected or indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood in specific circumstances. The structures, proportions, sizes, etc. illustrated in the drawings attached to this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions that the present invention can be implemented, so they have no technical substantive significance. Any structural modification, change in the proportional relationship or adjustment of the size, without affecting the effects and purposes that the present invention can produce, should still fall within the scope of the technical content disclosed by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention.

[0070] Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0071] Example 1

[0072] This embodiment 1 provides an occluder weaving mold for weaving the main body of an ASD (atrial septal defect) occluder or the main body of a PFO (patent foramen ovale) occluder. It should be noted that since the occluder main body still needs to undergo pre-shaping, closing, heat setting and other steps after weaving, the occluder described in this embodiment is actually an elastic woven mesh frame formed by several braided wires after weaving, rather than the final finished product of the occluder main body.

[0073] refer to Figure 1 The occluder braiding mold includes a braiding mold body 100, which has a roughly long cylindrical structure with a circumferential side surface, a top surface, and a bottom surface; preferably, the braiding mold body 100 is a detachable structure, so that its structure is easy to disassemble, assemble and reassemble, and it is convenient to withdraw the braiding mold body 100 after the elastic braiding mesh is braided.

[0074] Specifically, the weaving mold body 100 is composed of several modular components, and the modular components can be disassembled and assembled by splicing, snap-on or threaded connection. After disassembly, the modular components can be taken out from the woven elastic weaving grid. Since the elastic weaving grid can have different sizes, the specific shape, size and connection method of the modular components are no longer specifically limited in this embodiment, and technical personnel in this field can freely adjust them according to the actual needs of the final product.

[0075] Preferably, since the weaving mold body 100 needs to be pre-shaped together with the elastic weaving grid in a high temperature environment after the weaving of the weaving wire 300 is completed, the weaving mold body 100 is preferably made of thermally stable materials to avoid deformation in a high temperature environment and affect the structure of the elastic weaving grid. Specifically, ceramic materials or metal materials may be selected.

[0076] In a preferred embodiment, the circumferential side has a plurality of grooves 110, and the grooves 110 are arranged to extend axially along the circumferential side, and the width of the grooves 110 is greater than the diameter of the braided wire 300, so that the ends of the grooves 110 can be used to fix the braided wire 300; the protrusions between adjacent grooves 110 are groove columns, which can radially support the braided wire 300 when the braided wire 300 is wound.

[0077] Preferably, the number of the grooves 110 is the same as or different from the number of the braided wires 300; specifically, the number of the grooves 110 can be set to 28, 30, 32, 34, 36, etc., which is not specifically limited here.

[0078] In a preferred embodiment, both the top surface and the bottom surface are provided with braiding columns 120 for mounting the braided wire 300. Taking the top surface as an example, the braiding columns 120 are provided with several stages from the outside to the inside along the radial direction of the top surface, and the braiding columns 120 of each stage are arranged along the circumferential direction. In an optional embodiment, the number of braiding columns 120 of each stage decreases from the outside to the inside, and at the last stage, only one or several braiding columns 120 are provided, and are located at the center of the top surface or near the center.

[0079] Preferably, the braided column 120 may be provided with 3 orders, 4 orders, 5 orders, etc., which are not specifically limited here. It should be noted that the more orders or the total number of the braided column 120, the denser the braiding of the braided wire 300 on the top surface, the corresponding radial support force of the occluder disk will increase, and the resistance to being retracted into the sheath will increase accordingly, and the pushing resistance in the sheath will also increase accordingly. Therefore, it is necessary to increase or decrease the order / total number of the braided column 120 according to actual clinical needs.

[0080] In a preferred embodiment, a channel forming column 130 is further provided between the first-order braiding column 120 and the last-order braiding column 120. Optionally, the diameter of the channel forming column 130 is larger than the diameter of the braiding column 120. The braiding wire 300 bypasses the channel forming column 130 for weaving when it is wrapped around the top surface, and a larger grid can be formed on the elastic braiding frame, which is defined as a puncture channel 440, so that the finally formed occluder disk can have the reserved puncture channel 440, which is convenient for later re-intervention treatment.

[0081] In a preferred embodiment, according to the differences in minimally invasive interventional surgeries such as radiofrequency ablation, left atrial appendage occlusion and mitral valve treatment, the models and specifications of the occluders are different, so different puncture channel 440 sizes need to be preset, so the diameter of the channel forming column 130 is preferably 4-6mm; more preferably, the relative position between the puncture channel 440 and the waist 430 is set according to the size of common atrial septal defects and the size of the patent foramen ovale channel.

[0082] Taking the 4-order braiding column 120 as an example, the braiding column 120 at the outermost order is defined as the 1st order, i.e. the first order, and the braiding column 120 at the innermost order is defined as the 4th order, i.e. the last order. The channel forming column 130 is arranged between the 1st order and the 4th order, and the 2nd order and the 3rd order are no longer arranged at the position where the channel forming column 130 exists.

[0083] When four stages of braiding columns 120 are provided, preferably, the first stage is provided with 12 braiding columns 120 , the second stage is provided with 9 braiding columns 120 , the third stage is provided with 6 braiding columns 120 , and the fourth stage is provided with 1 braiding column 120 .

[0084] Preferably, the first-order braiding columns 120 are circumferentially equidistantly arranged, and the second-order and third-order braiding columns 120 are equidistantly arranged after being separated by the channel forming columns 130, so as to make the braiding structure of the final braided mesh more regular.

[0085] Preferably, one channel forming column 130 may be provided, or multiple channel forming columns 130 may be provided circumferentially. When only one channel forming column 130 is provided, there is only one puncture channel 440 on the finally formed occluder disk, and the puncture channel 440 may not be in the expected position after implantation. When multiple channel forming columns 130 are provided, there are multiple puncture channels 440 on the finally formed occluder disk, which is more convenient for later puncture.

[0086] Preferably, two, three, four or more channel forming pillars 130 may be provided.

[0087] Preferably, the arrangement of the weaving columns 120 and the channel forming columns 130 on the bottom surface of the weaving mold body 100 is the same as that on the top surface, and therefore will not be described in detail.

[0088] In a preferred embodiment, taking into account the formed puncture channel 440, after removing the channel forming mold 233, due to the elasticity of the braiding wire 300, the puncture channel 440 may be deformed to a certain extent. Therefore, corresponding track limiting columns are set on the circumferential side of the braiding mold body 100, so that the braiding wire 300 can form a side hole 301 when it is wound and woven along the circumferential side, so that the size of the formed puncture channel 440 is more stable.

[0089] Specifically, the position of the side hole 301 is calculated according to the designed occluder disk size, the winding method of the braided wire 300 , and the length of the braided wire 300 , and the trajectory limiting column is correspondingly set on the circumferential side of the braiding mold body 100 .

[0090] In a preferred embodiment, since the elastic woven mesh needs to be axially compressed and shaped to become an occluder, a side hole 301 is provided at a position of the elastic woven mesh corresponding to the disk surface, and the side hole 301 can be deformed in the major and minor axis dimensions after heat setting, and its position and size after deformation respectively correspond to the position and size of the puncture channel 440 to enhance the structural stability of the puncture channel 440. Therefore, when a plurality of puncture channels 440 are provided circumferentially, a plurality of side holes 301 are correspondingly provided circumferentially.

[0091] Preferably, when the final occluder product is a PFO occluder, its waist 430 has a shorter axial dimension and a larger radial dimension. At this time, three groups of trajectory limit columns are set on the circumferential side of the weaving mold body 100, and they respectively correspond to the positions of the inner side of the left disk 410 and the right disk 420 of the elastic weaving frame after heat setting.

[0092] Preferably, when the final occluder product is an ASD occluder, its waist 430 has a longer axial dimension and a smaller radial dimension, and the left disk surface 410 has a larger opening. At this time, only one set of track limit columns is set on the circumferential side of the weaving mold body 100, corresponding to the position of the right disk surface 420 of the elastic weaving frame after heat setting.

[0093] Example 2

[0094] This embodiment 2 provides an occluder shaping mold, and the elastic braided mesh frame woven in the above embodiment 1 is preferably heat-shaped by the shaping mold provided in this embodiment 2 to form a stable occluder main structure. Specifically, the occluder shaping mold described in this embodiment can heat-shape the elastic braided mesh frame into an ASD occluder or a PFO occluder. Those skilled in the art should understand that for different types of occluders, at least the shapes of the shaping molds for their disks and / or waists are different.

[0095] refer to Figure 2-Figure 4 Taking the shaping mold of the ASD occluder as an example, the shaping mold 200 of the occluder includes a fixing component 210, a molding component 230 and a locking component 220, wherein the molding component 230 is used to shape the elastic braided mesh frame into the occluder, the fixing component 210 is used to axially clamp and fix the molding component 230, and the locking component 220 is used to axially lock the fixing component 210. Those skilled in the art should understand that due to the difference in structure between the ASD occluder and the PFO occluder, when the occluder shaping mold 200 in this embodiment is used to shape the PFO occluder, the size of the waist inner mold 236 thereof is correspondingly reduced, and the specific size can be adjusted according to the shape requirements of the final product, and the specific specifications are not limited here.

[0096] In a preferred embodiment, the fixing assembly 210 includes a mold fixing top plate 211 and a mold fixing bottom plate 212, and the molding assembly 230 is arranged between the mold fixing top plate 211 and the mold fixing bottom plate 212; more preferably, a plurality of columns are arranged below the mold fixing top plate 211, and the columns correspond to the braided wires 300 of each order on the top surface, such as Figure 10-12 , to ensure that the braided mesh and the occluder shaping mold 200 are tightly and correctly matched.

[0097] In a preferred embodiment, the locking assembly 220 includes a screw 221 and a nut 222 , which cooperate to lock the mold fixing top plate 211 and the mold fixing bottom plate 212 .

[0098] In a preferred embodiment, the molding assembly 230 includes a top mold 231 , a bottom mold 232 , a left disk inner mold 234 , a right disk inner mold 235 , a waist inner mold 236 , a waist outer mold 237 , and a channel molding mold 233 .

[0099] Preferably, the specific shapes of the left disc inner mold 234, the right disc inner mold 235, the waist inner mold 236 and the waist outer mold 237 are related to the specific type of the finished occluder. When the occluder is an ASD occluder, the shapes of the above four can limit the elastic braided mesh frame to be heat-formed into the shape of the ASD occluder; when the occluder is a PFO occluder, the shapes of the above four can limit the elastic braided mesh frame to be heat-formed into the shape of the PFO occluder.

[0100] Preferably, the channel forming mold 233 is axially arranged and passes through the top mold 231 and the bottom mold 232. Its size is larger than that of the column, and is used to make the reserved puncture channel 440 a channel with more stable dimensions. The shape memory property of the braided wire 300 is utilized to make its structure more stable through heat setting.

[0101] In a preferred embodiment, a through hole for the channel forming mold 233 to pass through is provided on the mold fixed top plate 211 and the mold fixed bottom plate 212; specifically, an external thread is provided on the top of the channel forming mold 233, and an internal thread is provided in the through hole of the mold fixed top plate 211, and the two are connected by threads; the channel forming mold 233 is passed through the through hole of the mold fixed bottom plate 212, and the two are not connected, so as to facilitate the withdrawal of the channel forming mold 233 from the mold fixed top plate 211 after heat setting is completed.

[0102] Specifically, the number of channel forming molds 233 is consistent with the number of puncture channels 440, and one or more can be provided according to actual conditions.

[0103] Preferably, the top mold 231 is provided with a plurality of through holes having different shapes and sizes, through which the pillars and the channel forming mold 233 can pass respectively.

[0104] In a preferred embodiment, the occluder shaping mold 200 is made of thermally stable materials to avoid deformation in a high temperature environment and affect the structure of the occluder body 400 after thermal shaping. Specifically, ceramic materials or metal materials can be selected.

[0105] Example 3

[0106] This embodiment 3 provides a method for manufacturing an occluder, which requires the use of the occluder braiding mold of the above embodiment 1 and the occluder shaping mold of the above embodiment 2. The features already included in the above embodiments are naturally inherited in this embodiment and will not be repeated. It should be noted that the occluder in this embodiment can be an ASD occluder or a PFO occluder.

[0107] refer to Figure 5 Preferably, the occluder manufacturing method in this embodiment includes a weaving step and a heat setting step in sequence.

[0108] The weaving steps specifically include:

[0109] S310. The braiding wire is braided starting from the bottom surface of the braiding mold body, and is spirally wound upward along the circumferential side surface. After reaching the top surface, the braiding wire is bypassed by the braiding column and is spirally wound downward along the circumferential side surface in the reverse direction to complete the braiding of a single braiding wire.

[0110] Preferably, the braided wire 300 is made of a polymer material or an alloy material, such as a nickel-titanium alloy wire, and the phase transition temperature As of the nickel-titanium alloy wire is stable at -15°C±15°C.

[0111] like Figure 6 Preferably, taking the 4-stage weaving mold body 100 as an example, the 1st stage is provided with 12 weaving columns 120, the 2nd stage is provided with 9 weaving columns 120, the 3rd stage is provided with 6 weaving columns 120, and the 4th stage is provided with 1 weaving column 120; each stage is numbered counterclockwise with Arabic numerals 1, 2, 3, 4..., for example, 1-1 is column No. 1 of the 1st stage, and at the same time, a channel forming column 130 is provided on the top surface, and 36 grooves 110 are set on the circumferential side, and are numbered counterclockwise as grooves 1-36, and the number of the weaving wires 300 is the same as the grooves 110, which is also 36.

[0112] Taking the braided wire 300 winding 360° as an example, the braided wire 300 extending from the 36th slot is mounted on the first-stage braided column 120, and the winding method is as follows: Figure 7-9 shown.

[0113] Preferably, the braiding wire 300 is fixed to the groove columns between No. 36 and No. 35 on the bottom surface of the braiding mold body 100, extending from the bottom surface of groove No. 36, and circling 360° along the circumferential side of the braiding mold body 100 to the top surface of groove No. 36, passing through the first-stage braiding columns 1-2 and the top surface of groove No. 8, and circling 360° along the circumferential side to the bottom surface of groove No. 8, and fixed. At this point, the braiding of one braiding wire 300 is completed.

[0114] S320. Repeat the above steps until the winding of the first-order braiding column is completed.

[0115] Preferably, according to the preferred implementation in the above step S310, and so on, the winding and braiding of all first-order braiding columns 120 are completed in sequence.

[0116] S330. Weaving in steps from outside to inside, the braided wires bypass the channel forming column to reserve a puncture channel, the size of the puncture channel is larger than the size of the braided mesh, until all the braided wires are woven to obtain a braided mesh, and all the braided wires in the braided mesh are woven with the same material.

[0117] refer to Figure 10-13Preferably, the weaving starts from the first order, the second order is woven on the basis of the first order, the third order is woven on the basis of the second order, and the fourth order is woven on the basis of the third order; the first order to the fourth order are woven in sequence to ensure the stability of the disk surface, and the fourth order is the braided wire 300 that spans the disk surface to further provide radial support for the disk surface. The final top surface pattern is as follows Fig.14 shown.

[0118] Preferably, according to the preferred implementation of the above step S310 and step S320, and so on, the 2nd to 4th order weaving is completed.

[0119] In a preferred embodiment, it also includes: Step S331. The braiding wire bypasses the track limiting column when braiding and winding along the circumferential side of the braiding mold body until all the braiding wires are braided to obtain a braided mesh with side holes.

[0120] Preferably, a trajectory limiting column is arranged on the circumferential side of the braiding mold body 100. When the braiding wire 300 is wound around the circumferential side of the braiding mold body 100, it bypasses the trajectory limiting column to form a braided mesh with side holes 301, so as to be more conducive to the shaping of the occluder with a preset puncture channel 440; specifically, the specific position of the side hole 301 is set according to the different specifications of the occluder.

[0121] S332. The size of the side hole obtained by weaving is larger than the size of the puncture channel, and the side hole can correspond to the puncture channel after the elastic woven mesh frame is heat-set.

[0122] In a preferred embodiment, the position of the side hole 301 is determined by calculating the deformation of the side hole 301 when the woven mesh is heat-set; specifically, the side hole 301 can be set to an elliptical shape, and the long axis size is shortened by 2 times and the short axis size is expanded by 2 times after heat-setting.

[0123] In another preferred embodiment, the position of the side hole 301 is calculated according to the designed occluder disk size, the winding method of the braided wire 300, and the length of the braided wire 300, such as Fig.15 , Fig.16 Take the method shown as an example for marking.

[0124] like Fig.15 In a preferred embodiment, taking the PFO occluder as an example, the side holes 301 are sequentially arranged on the inner side of the left disk surface 410 and the right disk surface 420 after the braided mesh is heat-set, and the side holes 301 arranged on the left disk surface 410 and the right disk surface 420 can correspond one-to-one with the puncture channels 440 after the braided mesh is heat-set.

[0125] like Fig.16In another preferred embodiment, taking the ASD occluder as an example, the side hole 301 is only arranged on the right disk surface 420 after the woven mesh is heat-formed, and the side hole 301 arranged on the right disk surface 420 can correspond to the preset puncture channel 440 after the elastic woven mesh frame is heat-formed.

[0126] S340. Pre-shape and close the woven mesh to obtain an elastic woven mesh frame.

[0127] Preferably, the pre-forming step specifically includes: placing the braided mesh together with the braiding mold body 100 into a specific environment for pre-forming. The specific environmental conditions vary according to the braided wire 300. The common material nickel-titanium alloy material is in an inert gas environment, such as argon, and the pre-forming temperature is 530°C.

[0128] Preferably, the braided mesh is welded into a spherical shape by a metal welding process such as plasma welding to obtain an elastic braided mesh frame; the closing position of the braided mesh needs to correspond to the specifications of the occluder. Different occluders require different braided mesh lengths for molding, and examples are not listed one by one here.

[0129] Preferably, in this embodiment, the braided mesh and its plug head are made of the same material to reduce local galvanic corrosion caused by the polarity difference between different types of metals and improve the stability of the occluder.

[0130] S350. Place the elastic woven mesh frame into the forming component, and the channel forming mold penetrates into the puncture channel and limits it.

[0131] Preferably, in order to make the puncture channel 440 a channel with more stable dimensions, a channel forming component is specially provided, and the shape memory property of the braided wire 300 is utilized to stabilize the dimensions of the puncture channel 440 by heat setting.

[0132] Preferably, the channel forming component is the channel forming mold 233 in the above-mentioned embodiment 2. Correspondingly, a channel for the channel forming mold 233 to pass through is axially provided in the molding component 230. The channel forming mold 233 can transform the reserved puncture channel 440 into a channel with more stable dimensions, and utilizes the shape memory characteristics of the braided wire 300 to make its structure more stable through heat setting.

[0133] Preferably, the mold fixing top plate 211 and the mold fixing bottom plate 212 are provided with through holes for the channel forming mold 233 to pass through, the top of the channel forming mold 233 is provided with external threads, and the through hole of the mold fixing top plate 211 is provided with internal threads. After the channel forming mold 233 is inserted into the forming component 230, its top is connected to the mold fixing top plate 211 through threads. S360. The forming component and the braided mesh are locked by the fixing component and the locking component, and heat-shaped to obtain an occluder body having a left disk surface, a right disk surface, a waist and a puncture channel.

[0134] Preferably, after the occluder shaping mold 200 is locked as a whole by the locking assembly 220, it is placed in a specific environment for pre-shaping. The specific environmental conditions vary according to the braided wire 300. Common nickel-titanium alloy materials are around 530°C in an inert gas environment.

[0135] S370. Sew the flow-blocking membrane to obtain the occluder.

[0136] In a preferred embodiment, the baffle film is cut according to different occluder specifications to ensure that the baffle film can be evenly spread at the suture site; taking the ASD occluder as an example, the baffle film is first sewn at the waist 430, then the left disk surface 410, and finally the right disk surface 420.

[0137] Preferably, the sewing and knotting of the flow-blocking membrane may be carried out in any manner disclosed in the prior art, which will not be limited here.

[0138] Example 4

[0139] This embodiment 4 provides an occluder, which can be manufactured using the molds in the above embodiments 1 and 2, or using the method in the above embodiment 3. The features already included in the above embodiments 1-3 are naturally inherited in this embodiment and will not be repeated. It should be noted that the occluder in this embodiment can be an ASD occluder or a PFO occluder.

[0140] refer to Figure 17-20 In a preferred embodiment, the occluder includes an occluder body 400 and a flow-blocking membrane. The occluder body 400 is formed by heat-setting an elastic woven mesh frame, and includes a left disk surface 410, a right disk surface 420 and a waist 430; the flow-blocking membrane is sewn to the left disk surface 410, the right disk surface 420 and the waist 430 respectively.

[0141] Preferably, the occluder body 400 is woven from braided wires 300 of nickel-titanium alloy. After being implanted in the human body and deployed, the left disk surface 410 is positioned in the left atrium, and the right disk surface 420 is positioned in the right atrium. The two together clamp the atrial septal defect or the foramen ovale, and the waist 430 connecting the left disk surface 410 and the right disk surface 420 is positioned in the atrial septal defect or the foramen ovale.

[0142] Preferably, since patients have different physiological or pathological conditions, in order to adapt the occluder to different patients and function better, the size or shape of the left disk 410, the right disk 420 and the waist 430 can be adaptively adjusted or selected, which will not be repeated here.

[0143] In a preferred embodiment, the thickness of the flow-blocking membrane is 0.05-0.08 mm. Depending on the size of the occluder, the optional material includes any one of polymer materials such as polyester coating, polyurethane coating, polytetrafluoroethylene coating, etc.

[0144] Preferably, the flow-blocking membrane is sewn onto the occluder body 400 by non-absorbable sutures, and optional materials include nylon (polyamide 6) fiber, polyethylene fiber, polytetrafluoroethylene fiber, etc.

[0145] like Fig.17 , Fig.18 In a preferred embodiment, the occluder is a PFO occluder, and puncture channels 440 are provided on the inner side of the left disk surface 410 and the right disk surface 420 thereof, and the axially adjacent puncture channels 440 correspond to each other and are connected. Optionally, the number of puncture channels 440 on the left disk surface 410, the right disk surface 420 and the waist 430 is 1 to 4, preferably 3, and arranged circumferentially;

[0146] like Fig.19 , Fig. 20 In another preferred embodiment, the occluder is an ASD occluder, and a puncture channel 440 is provided on its right disk surface 420. The puncture channel 440 axially penetrates the entire ASD occluder. Optionally, the number of puncture channels 440 on the right disk surface 420 is 1 to 4, preferably 3 circumferentially distributed.

[0147] In this embodiment, the braided wire 300 of the occluder is connected and fixed with the plug head using the same material, thereby preventing the galvanic corrosion that may occur after the occluder is implanted in the heart. In addition, a puncture channel 440 is reserved on the occluder to provide the patient with an opportunity for further interventional treatment.

[0148] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. An occluder braiding mold, characterized in that: It includes a braiding mold body, which is used to braid an elastic braiding grid of the occluder, and the braiding mold body is in the shape of a long cylinder, and has a circumferential side surface and a top surface and a bottom surface at both ends of the axial direction; The circumferential side surface is provided with a plurality of longitudinally extending grooves; The top surface is provided with a braiding column for mounting the braided wire, and the braiding column is provided with several steps from the outside to the inside along the radial direction of the top surface, and the braiding columns of each step are arranged along the circumferential direction. A channel forming column is also provided between the braiding columns of the first step and the last step, which is used to reserve a puncture channel on the elastic braided mesh frame; The bottom surface is also provided with the braiding columns and the channel forming columns, and the distribution of the braiding columns on the bottom surface is the same as that on the top surface.

2. The occluder braiding mold according to claim 1, characterized in that: The braided column is provided with 1-n steps from the outside to the inside, n>2, the nth step is provided at a position close to the center of the top surface, and the channel forming column is provided between the 1st step and the nth step; The channel forming column is provided with one, or a plurality of channel forming columns are provided along the circumferential direction.

3. The occluder braiding mold according to claim 1, characterized in that: The circumferential side surface is provided with a track limiting column for guiding the braiding wire to form a side hole when it is wound and braided along the circumferential side surface.

4. An occluder shaping mold, used for heat-setting the elastic braided mesh woven by the occluder braiding mold according to claim 1 into an occluder body, characterized in that: It includes a fixing component, a molding component and a locking component; The fixing assembly comprises a mold fixing top plate and a mold fixing bottom plate, the molding assembly is arranged between the mold fixing top plate and the mold fixing bottom plate, and the fixing assembly is used to axially clamp and fix the molding assembly; a plurality of columns are arranged below the mold fixing top plate, and the columns correspond to the braided wires; The locking assembly is used to axially lock the fixing assembly; The molding assembly is used to shape the elastic woven mesh frame into an occluder, and the molding assembly includes a top mold, a bottom mold, a channel molding mold, a left disk inner mold, a right disk inner mold, a waist inner mold, and a waist outer mold; the channel molding mold is axially arranged and passes through the top mold and the bottom mold, and is used to shape the puncture channel reserved on the disk surface of the occluder; the top mold is provided with a plurality of through holes, and the through holes are for the columns and the channel molding mold to pass through.

5. The occluder shaping mold according to claim 4, characterized in that: The diameter of the channel forming die is larger than the diameter of the column; The channel forming die is provided with one, or a plurality of channel forming dies are provided along the circumferential direction.

6. A method for manufacturing an occluder, characterized in that: It includes a weaving step and a heat setting step; The braiding step is implemented based on the occluder braiding mold according to any one of claims 1 to 3, and includes: The braiding wire is spirally wound upward along the circumferential side surface starting from the bottom surface of the braiding mold body, and then, after reaching the top surface, it is wound around the braiding column and spirally wound downward along the circumferential side surface in the reverse direction to complete the braiding of a single braiding wire; Repeat the above steps until the winding of the first-order braided column is completed; Weaving in order from outside to inside, the braided wires bypass the channel forming column to reserve a puncture channel, the size of the puncture channel is larger than the size of the braided mesh, until all the braided wires are woven to obtain a braided net, and all the braided wires in the braided net are woven with the same material; Pre-shaping and closing the woven mesh to obtain an elastic woven mesh frame; The heat setting step is implemented based on the occluder shaping mold according to claim 4 or 5, comprising: The elastic braided mesh frame is placed into the forming component, and the channel forming mold is inserted into the puncture channel and limited; The forming component and the elastic braided mesh frame are locked by the fixing component and the locking component, and heated to be formed, so as to obtain an occluder body having a left disk surface, a right disk surface, a waist and a puncture channel; The blocking membrane is sewn to obtain the occluder.

7. The method for manufacturing an occluder according to claim 6, characterized in that: In the weaving step, it also includes: Using the occluder braiding mold as claimed in claim 3 to wrap the braided wire; The braiding wires bypass the track limiting posts when braiding and winding along the circumferential side of the braiding mold body until all the braiding wires are braided to obtain a braided mesh with side holes; The size of the side hole obtained by weaving is larger than the size of the puncture channel, and the side hole can correspond to the puncture channel after the step of heat setting the elastic woven mesh frame.

8. The method for manufacturing an occluder according to claim 7, characterized in that: In the weaving step, it also includes: The braiding wires bypass the track limiting pillars when braiding and winding along the circumferential side of the braiding mold body until all the braiding wires are braided to obtain a braided mesh with side holes, and the side holes are sequentially arranged on the disk surface positions after the elastic braiding mesh frame is heat-set; The side holes arranged on the disk surface can correspond one-to-one with the puncture channels after the elastic braided mesh frame is heat-set.

9. An occluder, the occluder being manufactured based on the occluder manufacturing method according to any one of claims 6 to 8, characterized in that: include: - The occluder body is a heat-set elastic woven mesh frame, including a left disk, a waist and a right disk; At least a puncture channel is provided on the right disk surface, and the size of the puncture channel is larger than the mesh size of the elastic woven mesh frame; - a flow-blocking film, the flow-blocking film comprising a left disk flow-blocking film, a right disk flow-blocking film, and a waist flow-blocking film; The left disc flow-blocking film is arranged in the left disc surface, the right disc flow-blocking film is arranged in the right disc surface, and the waist flow-blocking film is arranged in the waist.

10. The occluder according to claim 9, characterized in that: The puncture channel is arranged on the left disk surface, the right disk surface and the waist.

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