A stent manufacturing tool and method

Abstract

The present application relates to a stent manufacturing tool and a manufacturing method. The stent manufacturing tool comprises a hollow main body structure and an adjusting unit, a wave-shaped ring is sleeved on the main body structure, and the adjusting unit is arranged on the main body structure and used for adjusting the outer diameter of the main body structure. Thus, after the inner connecting layer, the outer connecting layer and the wave-shaped ring are hot melt bonded, the diameter of the main body structure is adjusted through the adjusting unit, the diameter of the main body structure is reduced, the wave-shaped ring is automatically removed, and the stent is prevented from being deformed due to the manual pulling of the wave-shaped ring and the pulling of the inner connecting layer and the outer connecting layer.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a stent manufacturing tool and manufacturing method. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] In the manufacturing process of the laminated stent, a corrugated ring needs to be mounted on a columnar structure, and then the inner and outer connecting layers on both sides of the corrugated ring are thermo-pressed together. In the prior art, there is a certain radial pressure between the corrugated ring and the columnar structure. Therefore, during the demolding process of the corrugated ring, there is a large frictional force between the corrugated ring and the main structure, which causes the inner and outer connecting layers to be stretched, resulting in stent deformation. Summary of the Invention

[0004] Therefore, it is necessary to provide a support manufacturing tool. The support includes a corrugated ring. The support manufacturing tool includes a hollow main structure and an adjustment unit. The corrugated ring is sleeved on the main structure, and the adjustment unit is disposed on the main structure. The adjustment unit is used to adjust the outer diameter of the main structure.

[0005] Optionally, an opening is provided on the side wall of the main structure, and the opening extends through both ends of the main structure along its axial direction.

[0006] Optionally, the adjustment unit includes an adjustment mechanism connected to the opposite side walls of the opening. The adjustment mechanism is used to drive the opposite side walls of the opening to move towards each other or away from each other.

[0007] Optionally, the adjustment mechanism includes a winding post and a connecting line. The two ends of the connecting line are connected to the opposite side walls of the opening. The connecting line is fixedly connected to the winding post. The winding post is used to drive the opposite side walls of the opening to move through the connecting line.

[0008] Optionally, the adjustment mechanism also includes a stop, which is mounted on the winding post and located between the opposite side walls of the opening.

[0009] Optionally, the adjustment unit includes an engagement structure, the opening includes a first end face and a second end face disposed opposite to each other, the engagement structure includes a protrusion and a groove, the protrusion is disposed on the first end face, and the groove is opened on the second end face, when the opening is open, the protrusion is at least partially located outside the groove, and when the opening is closed, the protrusion is located inside the groove.

[0010] Optionally, the main structure includes a first joint and a second joint that are movably connected. The first joint and the second joint can move along the axial direction of the main structure. The first end face is located on the first joint and the second end face is located on the second joint.

[0011] Optionally, the bracket manufacturing tool also includes a connector, and through holes are provided at both axial ends of the main structure. The through holes are at least partially located on the first joint and the second joint, and the connector passes through the through holes to connect the first joint and the second joint.

[0012] Optionally, a receiving groove is provided on the side wall of the main structure, and the side wall of the receiving groove includes a guide surface structure, which is an inclined surface or an arc surface.

[0013] Compared with the prior art, the stent manufacturing tool of the present invention has the following advantages: After the inner connecting layer, outer connecting layer and corrugated ring are thermally bonded together, the diameter of the main structure is adjusted by the adjustment unit to reduce the diameter of the main structure, thereby causing the tubular main body to detach on its own. This avoids the need for workers to manually pull the corrugated ring off, which would cause tension on the inner and outer connecting layers and lead to deformation of the support.

[0014] The present invention also provides a method for manufacturing a support, which uses the support manufacturing tool described above to manufacture the support, including: providing at least one connecting wire, winding the connecting wire around a main structure to obtain an inner connecting layer; installing a corrugated ring on the outside of the main structure, and winding another connecting wire around the corrugated ring to obtain an outer connecting layer; heat treatment to bond the inner connecting layer, the corrugated ring, and the outer connecting layer to obtain a tubular main body; adjusting the outer diameter of the main structure to allow the tubular main body to detach.

[0015] Compared with the prior art, the stent manufacturing method of the present invention has the following advantages: This invention heat-treats the corrugated annular structure, inner connecting layer, and outer connecting layer before adjusting the diameter of the main structure. This allows the main structure to exert radial pressure on the inner and outer connecting layers, ensuring their shape is set during the heat treatment process. After the heat setting is complete, the diameter of the main structure is adjusted to reduce its size, causing the tubular main body to detach on its own. This avoids the main structure pulling on the inner connecting layer and causing deformation of the tubular main body, thus increasing the manufacturing efficiency of the support. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of the bracket in an embodiment of the present invention; Figure 2 This is a schematic diagram of the structure of the support manufacturing assembly in Embodiment 1 of the present invention; Figure 3 This is an isometric view of the main structure in Embodiment 1 of the present invention; Figure 4 This is a schematic diagram of the unfolded structure of the main body in Embodiment 1 of the present invention; Figure 5 For the present invention Figure 2Enlarged structural diagram at point A in the diagram; Figure 6 This is a schematic diagram of the structure in Embodiment 1 of the present invention, showing how the winding post drives the connecting line to move. Figure 7 For the present invention Figure 2 Enlarged schematic diagram of the structure at point B in the diagram; Figure 8 This is a schematic diagram of the structure of the support manufacturing assembly in Embodiment 2 of the present invention; Figure 9 This is a top view of the main structure in Embodiment 2 of the present invention; Figure 10 This is a schematic diagram of the structure of the first and second joints in Embodiment 2 of the present invention; Figure 11 This is another structural schematic diagram of the first and second joint portions in Embodiment 2 of the present invention; Figure 12 For the present invention Figure 8 A schematic diagram of the cross-sectional structure at point AA; Figure 13 This is a top view of the support manufacturing assembly in Embodiment 3 of the present invention; Figure 14 This is a front view of the support manufacturing assembly in Embodiment 3 of the present invention; Figure 15 For the present invention Figure 14 Enlarged schematic diagram of the structure at point C; Figure 16 This is an exploded view of the support manufacturing assembly in Embodiment 3 of the present invention; Figure 17 This is a cross-sectional structural diagram of the support manufacturing assembly in Embodiment 3 of the present invention; Figure 18 For the present invention Figure 14 A schematic diagram of the cross-sectional structure at point BB; Figure 19 This is a flowchart of the support manufacturing method in Embodiment 4 of the present invention; Figure 20 This is a flowchart of the bracket manufacturing method in Embodiment 5 of the present invention. Detailed Implementation

[0017] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0018] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0019] Example 1 This embodiment provides a bracket manufacturing tool 100, such as Figures 1 to 4 As shown, it includes a main structure 110 and an adjustment unit 130. The adjustment unit 130 is disposed on the main structure 110 and is used to adjust the outer diameter of the main structure 110.

[0020] like Figure 1 As shown, the scaffold 900 includes a tubular body 910 and a covering 920, which is sewn onto the tubular body 910. The tubular body 910 includes an inner connecting layer, corrugated annular structures, and an outer connecting layer. The inner connecting layer, corrugated annular structures, and outer connecting layer are bonded together, and the inner connecting layer and outer connecting layer are used to connect multiple corrugated annular structures. In this embodiment, the shape of the inner connecting layer and outer connecting layer is not limited; specifically, the inner connecting layer and outer connecting layer can be in the form of a mesh structure or a linear structure.

[0021] like Figure 2 , Figure 3 As shown, the main structure 110 is a tubular structure open at both ends or a hollow structure open at both ends. The main structure 110 is made of an elastic material or a shape memory metal material, specifically, it can be stainless steel or a nickel-titanium alloy. This embodiment does not limit the shape of the cross-section of the main structure 110. For example, the cross-section of the main structure 110 can be circular or elliptical. An opening 131 is provided on the main structure 110, which is arranged along the axial direction of the main structure 110 and extends through both ends of the main structure 110 along the axial direction. The ratio of the diameter d1 of the main structure 110 to the width d2 of the opening 131 is 8 to 30. Specifically, the ratio of the diameter d1 of the main structure 110 to the width d2 of the opening 131 can be 8, 13, 20, or 30. Under this ratio, the radial shrinkage of the main structure 110 is within the range of the material's ultimate elastic strain, thereby preventing the main structure 110 from exceeding its ultimate elastic strain and causing elastic deformation failure.

[0022] It is understood that opening 131 in the main structure 110 is one embodiment of the adjustment unit 130, and the diameter of the main structure 110 can be adjusted by setting the opening 131. For example, in one embodiment, such as Figure 3As shown, when it is necessary to reduce the diameter of the main structure 110, a radially inward pressure F1 is applied from the outside of the main structure 110 towards the center of the main structure 110, causing the opposite side walls of the opening 131 to move towards each other, thereby reducing the diameter of the main structure 110; when it is necessary to increase the diameter of the main structure 110, the radial pressure F1 on the outer side wall of the main structure 110 is removed or reduced, and the opposite side walls of the opening 131 are reset under the elastic force, thereby increasing the diameter of the main structure 110, thus realizing the diameter adjustment of the main structure 110.

[0023] In another embodiment, when it is necessary to increase the diameter of the main structure 110, a radially outward pressure F2 is applied from the inner wall of the main structure 110 to the outer side of the main structure 110, causing the opposite side walls of the opening 131 to move away from each other, thereby increasing the diameter of the main structure 110; when it is necessary to decrease the diameter of the main structure 110, the radial pressure F2 on the inner wall of the main structure 110 is removed or reduced, the opposite side walls of the opening 131 are reset, thereby reducing the diameter of the main structure 110, and thus realizing the diameter adjustment of the main structure 110.

[0024] Figure 4 This is a schematic diagram of the unfolded structure of the main structure 110 in this embodiment, as shown below. Figure 4 As shown, the receiving groove 160 and the winding groove 120 are formed on the circumferential sidewall of the main structure 110. The receiving groove 160 corresponds to the outline of the corrugated annular object, which is housed within the receiving groove 160. Specifically, the receiving groove 160 can have a corrugated or triangular structure. The winding groove 120 corresponds to the outline of the inner connecting layer. Specifically, the winding groove 120 can have a mesh, strip, or corrugated structure. The winding groove 120 is used to house the connecting wires, which intersect on the winding groove 120 to form the inner connecting layer.

[0025] The advantage of this design is that the main structure 110 has an installation groove 120 with a preset shape, which allows the corrugated ring to be accommodated in the receiving groove 160. After the inner connecting layer is thermally bonded to the corrugated ring, the diameter of the main structure 110 can be adjusted by the adjustment unit 130 to reduce the diameter of the main structure 110, thereby causing the corrugated ring to detach on its own. This avoids the need for workers to manually detach the tubular main body 910, which would cause tension on the inner and outer connecting layers and lead to deformation of the bracket.

[0026] Furthermore, to facilitate adjusting the spacing d2 between the opening 131 and the two side walls, such as... Figure 2 As shown, the adjustment unit 130 also includes an adjustment mechanism 140, which is connected to the opposite side walls of the opening 131. The adjustment mechanism 140 is used to drive the opposite side walls of the opening 131 to move towards each other or away from each other.

[0027] In this embodiment, as Figure 2 , Figure 5 As shown, the adjusting mechanism 140 includes a winding post 141 and a connecting wire 142. Both ends of the connecting wire 142 are connected to opposite side walls of the opening 131. The connecting wire 142 is wound around the winding post 141 and fixedly connected to it. Specifically, both ends of the connecting wire 142 are welded to opposite side walls of the opening 131, and the connecting wire 142 is wound around the winding post 141. In other embodiments, connecting ears are provided on opposite side walls of the opening 131, and connecting holes are opened on the connecting ears. The connecting wire 142 is wound around the connecting ears. In other embodiments, the connecting wire 142 includes a first connecting portion and a second connecting portion. Both ends of the first connecting portion are welded to one side wall of the opening 131 and the winding post 141, respectively, and both ends of the second connecting portion are welded to the other side wall of the opening 131 and the winding post 1241, respectively.

[0028] In one implementation, such as Figure 6 As shown, when it is necessary to reduce the diameter of the main structure 110, the winding post 141 is rotated, causing the winding post 141 to pull the connecting line 142. The connecting line 142 pulls the opposite side walls of the opening 131 to move towards each other, thus reducing the diameter of the main structure 110. When it is necessary to increase the diameter of the main structure 110, the winding post 141 is rotated to release the connecting line 142 to eliminate the constraint on the opposite side walls of the opening 131. The opposite side walls of the opening 131 move away from each other under the elastic force, thereby increasing the diameter of the main structure 110 and realizing the diameter adjustment of the main structure 110.

[0029] In other embodiments, the adjusting mechanism 140 can be any one of an electric push rod, a linear motor, or a telescopic cylinder. The adjusting mechanism 140 is welded or screwed to the inner wall of the main structure 110. The driving end of the adjusting mechanism 140 abuts against the inner wall of the main structure 110, and the movement direction of the driving end of the adjusting mechanism 140 is parallel to the movement direction of the opposite side walls of the opening 131. When it is necessary to increase the diameter of the main structure 110, the driving end of the adjusting mechanism 140 pushes the inner wall of the main structure 110 to move, causing the opposite side walls of the opening 131 to move away from each other, thereby increasing the diameter of the main structure 110. When it is necessary to decrease the diameter of the main structure 110, the driving end of the adjusting mechanism 140 retracts, causing the opposite side walls of the opening 131 to move towards each other, thereby decreasing the diameter of the main structure 110, thus realizing the diameter adjustment of the main structure 110.

[0030] Therefore, when it is necessary to remove the tubular main body 910, the diameter of the main body 110 is adjusted by the adjustment mechanism 140 driving the opposite side walls of the opening 131 to move towards each other or away from each other. This allows the tubular main body 910 to detach on its own, avoiding the need for workers to press the side walls of the main body 110, which would interfere with the detachment of the tubular main body 910.

[0031] Furthermore, such as Figure 2 and Figure 7 As shown, to prevent the opening 131 from shrinking excessively, the bracket manufacturing tool also includes a stop 150, which is mounted on the winding post 141 and located between the opposite side walls of the opening 131.

[0032] In this embodiment, the stop member 150 has a connecting hole with an internal thread, and one axial end of the winding post 141 has an external thread. The winding post 141 passes through the connecting hole and is threadedly engaged with the stop member 150. In other embodiments, the stop member 150 can also be welded or snapped onto the winding post 141. Thus, during the process of the adjusting mechanism 140 driving the opposite side walls of the opening 131 to move towards each other, the stop member 150, located on the opposite side walls of the opening 131, can stop the movement of the opposite side walls of the opening 131, preventing the opening 131 from excessively contracting and causing the main structure 110 to exceed its elastic deformation limit and fail.

[0033] Example 2 This embodiment provides a support manufacturing tool 200. The difference between this embodiment and Embodiment 1 is that, as Figure 8 , Figure 9 As shown, the adjustment unit 230 includes a meshing structure 232, which is respectively disposed on the opposite side walls of the opening 231. The meshing structure 232 is used to switch the main body structure 210 between an expanded state and a contracted state.

[0034] It should be noted that when the main structure 210 is in an expanded state, the opening 231 is open; when the main structure 210 is in a contracted state, the opening 231 is closed. In this embodiment, as... Figure 10 As shown, the opening 231 includes a first end face and a second end face disposed opposite to each other. The meshing structure 232 includes a protrusion 2321 and a groove 2322. The protrusion 2321 is disposed on the first end face, and the groove 2322 is formed on the second end face. Figure 9 As shown, when the main structure 210 is in an expanded state, the protrusion 2321 is at least partially located outside the groove 2322, as... Figure 10 As shown, when the main structure 210 is in an expanded state, the protrusion fits against the inner wall of the groove 2322.

[0035] In this way, during the process of adjusting the diameter of the main structure 210, pushing the opening 231 along the axial direction relative to the two side walls can switch the main structure 210 between the expansion and contraction states, avoiding the need for workers to press the main structure 210 radially from the side walls, which would interfere with the detachment of the wave-shaped ring and the inner connecting layer.

[0036] Furthermore, such as Figures 8 to 11 As shown, in order to facilitate the relative axial movement of the first end face and the second end face, the main body structure 210 includes a first joint 211 and a second joint 212 that fit together. The first joint 211 and the second joint 212 can move along the axial direction of the main body structure 210. The first end face is located on the first joint 211 and the second end face is located on the second joint 212.

[0037] It should be noted that, as Figure 9 As shown, the side end faces of the first joint 211 and the second joint 212 are fitted together to form the main body structure 210. The first joint 211 and the second joint 212 can move along the axial direction of the main body structure 210. The movement directions of the first joint 211 and the second joint 212 can be the same or opposite. The meshing structure 232 includes a first meshing structure 233 and a second meshing structure 234. The first meshing structure 233 is located at the first edge where the first joint 211 and the second joint 212 are fitted together, and the second meshing structure 234 is located at the second edge where the first joint 211 and the second joint 212 are fitted together.

[0038] In one implementation, such as Figure 10 As shown, when it is necessary to demold the tubular body 910, the main structure 210 is switched from an expanded state to a contracted state, pushing the first joint 211 to move along the first direction f1 and pushing the second joint 212 to move along the second direction f2. The first direction f1 and the second direction f2 are parallel and opposite, causing the protrusion 2321 to engage with the groove 2322, reducing the diameter of the main structure 210, and the tubular body 910 to detach itself, thereby achieving the demolding of the tubular body 910. Figure 10 As shown, when it is necessary to wind the connecting wire into the winding groove 220, the main structure 210 is switched from the contracted state to the expanded state, the first joint 211 is pushed along the second direction f2 along the axial direction, and the second joint 212 is pushed along the first direction f1 along the axial direction, so that the first end face and the second end face are reset, thereby causing the protrusion 2321 to abut against the second end face between the two adjacent grooves 2322.

[0039] Therefore, by including the first joint 211 and the second joint 212 in the main structure 210, the first joint 211 and the second joint 212 can move along the axial direction of the main structure 210, so that the workers can push the first joint 211 and the second joint 212 along the axial direction to switch the main structure 210 between the expansion state and the contraction state, thereby reducing the difficulty of demolding.

[0040] Furthermore, such as Figure 8 , Figure 9 As shown, in order to facilitate the installation of the first joint 211 and the second joint 212, the bracket manufacturing tool also includes a connector 240. One axial end of the main structure 210 is provided with a through hole 213, and the connector 240 passes through the through hole 213 to connect the first joint 211 and the second joint 212.

[0041] In this embodiment, the through hole 213 extends through both axial ends of the main structure 210 along its axial direction, and the through hole 213 is at least partially located on the first joint 211 and the second joint 212. The connector 240 includes a connecting shaft 241 and at least two limiting members 242. The connecting shaft 241 is inserted into the through hole 213, and external threads are provided at both axial ends of the connecting shaft 241. The limiting members 242 are provided with threaded holes, and the limiting members 242 are threadedly connected to the connecting shaft 241 to tighten the first joint 211 and the second joint 212. The limiting members 242 include a first limiting member 2421 and a second limiting member 2422. The first limiting member 2421 is connected to one end of the connecting shaft 241, and the second limiting member 2422 is connected to the other end of the connecting shaft 241.

[0042] Therefore, when the main structure 210 is in an expanded state, the axial ends of the first joint 211 and the second joint 212 are parallel, and the connector 240 tightens the first joint 211 and the second joint 212. During the process of winding the connecting wire or installing the corrugated ring, the first joint 211 and the second joint 212 can be prevented from shifting. When it is necessary to detach the tubular body 910, the connector 240 is loosened, and the first joint 211 and the second joint 212 are pushed to move relative to each other along the axial direction, so that the tubular body 910 detaches itself.

[0043] Furthermore, such as Figure 8 , Figure 12 As shown, in order to reduce the pulling effect of the main structure 210 on the inner connecting layer and the wave-shaped ring during the demolding process, at least one side wall of the receiving groove 250 and / or the winding groove 22 includes a guide surface structure 260, which is an arc-shaped surface or an inclined surface.

[0044] It should be noted that the receiving groove 250 is used to receive the corrugated annular object, and the outline of the receiving groove 250 corresponds to the outline of the corrugated annular object. The receiving groove 250 is arranged circumferentially along the main structure 210. The receiving groove 250 includes a first sidewall and a second sidewall, which are arranged opposite to each other. The guide surface structure 250 is located on the first sidewall and / or the second sidewall. The guide surface structure 260 can be an arc-shaped surface structure or an inclined surface structure. The guide surface structure 250 can also be located on the sidewall of the winding groove 220, which is used to receive the connecting wire.

[0045] In this way, during the process of the tubular main body 910 falling off, the guide surface structure 260 is provided on the side wall of the receiving groove 250 and / or the winding groove 220, so that the inner connecting layer and the wave-shaped ring can fall off along the guide surface structure 260, thereby making the falling off of the inner connecting layer smoother and avoiding the side wall of the main body structure 110 from pulling on the inner connecting layer and causing deformation of the inner connecting layer.

[0046] In other embodiments, an anti-adhesive layer is provided on the inner wall of the winding groove 220. The anti-adhesive layer can be either tin foil or aluminum foil. In this way, by providing the anti-adhesive layer, the adhesive force between the inner connecting layer and the winding groove 220 can be reduced, thereby reducing the difficulty of the inner connecting layer slipping off the winding groove 220.

[0047] Example 3 This embodiment provides a bracket manufacturing assembly, such as Figures 13 to 16 As shown, it includes a main structure 600 and a pressing device 700. The main structure 600 is inserted into the pressing device 700. At least two protruding structures 710 are provided on the inner wall of the pressing device 700. A receiving groove 610 is opened on the outer wall of the main structure 600. The receiving groove 610 is located between two adjacent protruding structures 710.

[0048] like Figure 14 , Figure 15 As shown, the main structure 600 is used to house the inner connecting layer, the wave-shaped annular object, and the outer connecting layer. A receiving groove 610 is provided on the side wall of the main structure 600, the contour of which corresponds to the contour of the wave-shaped annular object, and the wave-shaped annular object is housed within the receiving groove 610. A winding groove 620 is also provided on the outer side wall of the main structure 600, used to house connecting wires. The connecting wires intersect on the inner side of the wave-shaped annular object to form the inner connecting layer, and intersect on the outer side of the wave-shaped annular object to form the outer connecting layer.

[0049] like Figure 16 As shown, the pressing device 700 includes a first pressing member 720 and a second pressing member 730 arranged circumferentially along the main structure 600. The first pressing member 720 and the second pressing member 730 are detachably connected, and the protruding structure 710 is located on the inner wall of the first pressing member 720 and the second pressing member 730.

[0050] In this embodiment, the first pressing member 720 includes a first connecting ear 722, and the second pressing member 730 includes a second connecting ear 732. The first connecting ear 722 has a first connecting hole, and the second connecting ear 732 has a second connecting hole. Fasteners pass through the first and second connecting holes to connect the first pressing member 720 and the second pressing member 730. The pressing device 700 includes a first state where the tubular body 910 is pressed against the main structure 600, and a second state where the tubular body 910 is released. Thus, the first pressing member 720 and the second pressing member 730 are detachably connected, allowing the first pressing member 720 and the second pressing member 730 to be closed in the first state, and opened in the second state, thereby realizing the opening and closing of the pressing device 700 and facilitating the assembly and disassembly of the tubular body 910.

[0051] In other embodiments, the first pressing member 720 and the second pressing member 730 are arc-shaped and coaxially arranged. One end of the first pressing member 720 and the second pressing member 730 is hinged or connected by a shaft hole, and the other end of the first pressing member 720 and the second pressing member 730 is screwed or snapped. The first pressing member 720 can be rotated to open or close relative to the second pressing member 730.

[0052] The protruding structure 710 is located on the inner sidewall of the first pressing member 720 and the second pressing member 730. There are multiple protruding structures 710, which can be arranged at equal intervals or non-equal intervals in the circumferential direction. The protruding structures 710 are located on opposite sides of the receiving groove 610. The protruding structures 710 are used to press the inner connecting layer and the outer connecting layer together when the first pressing member 720 and the second pressing member 730 are closed.

[0053] In one embodiment, during the heat treatment of the tubular body 910, the pressing device 700 is in a first state, at which time, such as Figure 13 As shown, the first pressing member 720 and the second pressing member 730 enclose the installation space of the main structure 600. The main structure 600 is inserted into the pressing device 700. The first pressing member 720 and the second pressing member 730 are closed and press the inner connecting layer and the outer connecting layer onto the main structure 600. The corrugated annular object is located between two adjacent protruding structures 710. After the tubular main body 910 is heat-treated, the pressing device 700 is in the second state. At this time, the first pressing member 720 and the second pressing member 730 are opened, and then the main structure 600 is taken out to facilitate the demolding of the tubular main body 910.

[0054] It is worth explaining that in this embodiment, the inner connecting layer and the outer connecting layer serve to connect the waveform ring. The inner connecting layer and the outer connecting layer have a mesh structure. In this case, if the bonding points of the inner connecting layer and the outer connecting layer are not on opposite sides of the waveform ring, the connection between the inner connecting layer, the outer connecting layer and the waveform ring will fail.

[0055] Therefore, by having the main structure 600 inserted into the pressing device 700, the pressing device 700 can press the corrugated annular object onto the main structure 600. The inner wall of the pressing device 700 has a protruding structure 710 located on both sides of the receiving groove 610, so that the inner connecting layer and the outer connecting layer can form adhesive points on opposite sides of the corrugated annular object. In this way, after the inner connecting layer and the outer connecting layer are bonded, they can cover the corrugated annular object, which increases the probability of the inner connecting layer and the outer connecting layer connecting to the corrugated annular object after bonding, thereby increasing the manufacturing efficiency of the bracket.

[0056] Furthermore, in order to increase the bonding tightness between the inner and outer connecting layers after heat treatment, such as... Figure 16 As shown, this embodiment further defines the first pressing member 720 and / or the second pressing member 730 as including a housing portion, an elastic portion and a pressing portion, with the two ends of the elastic portion connected to the pressing portion and the housing portion respectively, and the protruding structure 710 disposed on the pressing portion.

[0057] It should be noted that the first pressing member 720 includes a first housing portion 723, a first elastic portion 724, and a first pressing portion 725. The two ends of the first elastic portion 724 are welded to the first housing portion 723 and the first pressing portion 725, respectively. The first elastic portion 724 is elastic and has a variable length. The second pressing member 730 includes a second housing portion 733, a second pressing portion 735, and a second elastic portion 734. The two ends of the second elastic portion 734 are welded to the second housing portion 733 and the second pressing portion 735, respectively. The second elastic portion 734 is elastic and has a variable length. The first housing portion 723 and the second housing portion 733 are connected by screws, and the side end faces of the first housing portion 723 and the second housing portion 733 are attached to each other. The first elastic portion 724, the first pressing portion 725, the second elastic portion 734 and the second pressing portion 735 are located inside the first housing portion 723 and the second housing portion 733. The first pressing portion 725 and the second pressing portion 735 have an arc-shaped structure and are arranged opposite to each other. The first pressing portion 725 and the second pressing portion 735 surround to form a tube structure. The diameter of the tube structure is smaller than the diameter of the main structure 600.

[0058] In one embodiment, when the pressing device 700 is in the first state, the first pressing part 725 presses the outer connecting layer onto the inner connecting layer under the elastic action of the first elastic part 724, and the second pressing part 735 presses the outer connecting layer onto the inner connecting layer under the elastic action of the second elastic part 734; when the pressing device 700 is in the second state, the pressing device 700 is opened, and the first pressing part 725 and the second pressing part 735 loosen the main structure 600.

[0059] It is worth explaining that in order for the tubular structure formed by the first pressing part 725 and the second pressing part 735 to accommodate the main structure 600, the inner diameter of the tubular structure must be larger than the diameter of the main structure 600. In this case, there must be a gap between the main structure 600 and the first pressing part 725 and the second pressing part 735. During the heat treatment process, the lack of pressure between the inner connecting layer and the outer connecting layer can easily generate gaps or bubbles, thereby reducing the stability of the inner connecting layer and the outer connecting layer after bonding.

[0060] Thus, by connecting the two ends of the elastic part to the pressing part and the shell part respectively, the elastic part can provide radial pressure to the pressing part, so that the pressing part can press the inner connecting layer and the outer connecting layer together, and the inner connecting layer and the outer connecting layer can be tightly bonded after heat treatment.

[0061] Furthermore, to facilitate the winding and forming of the inner and outer connecting layers, such as Figure 14 , Figure 15 and Figure 17 As shown, the winding groove 620 has a first waveform structure, the receiving groove 610 has a second waveform structure, the waveforms of the first waveform structure and the second waveform structure have a phase difference, and the protrusion structure 710 is arranged at intervals along the contour of the winding groove 620.

[0062] It should be noted that the winding groove 620 is formed on the circumferential sidewall of the main structure 600, the connecting wire is wound on the winding groove 620, and the waveform annular object is installed in the receiving groove 610. The phase difference between the waveforms of the receiving groove 610 and the winding groove 620 means that the winding groove 620 includes a first peak and a first trough, and the receiving groove 610 includes a second peak and a second trough. The interval distance refers to the distance d between the vertical lines at the first peak and the second peak. In other embodiments, the first peak and the second trough are arranged opposite each other, and the first trough and the second peak are arranged opposite each other.

[0063] like Figure 17 As shown, the protruding structure 710 is arranged along the contour of the winding groove 620. Figure 17The dashed lines represent the outlines of the winding groove 620 and the receiving groove 610, with a spacing between adjacent protrusions 710. For example, in one embodiment, the protrusions 710 are located on opposite sides of the intersection point p where the winding groove 620 and the receiving groove 610 intersect.

[0064] The advantage of this design is that, by providing a winding groove 620 on the main structure 600, the connecting wire can be wound around the winding groove 620 to form an inner connecting layer and an outer connecting layer. By setting the waveform phases of the first waveform structure and the second waveform structure to be opposite, the contours of the inner connecting layer and the waveform ring will not completely overlap. By having the protruding structures 710 spaced along the contour of the winding groove 620, the bonding points of the inner connecting layer and the outer connecting layer can be located on both sides of the waveform ring, thereby making the connection between the inner connecting layer, the outer connecting layer and the waveform ring more stable and reducing the possibility of the inner connecting layer and the outer connecting layer falling off the waveform ring.

[0065] Furthermore, to facilitate the winding of the outer layer connecting wires, this embodiment also limits the depth of the winding groove 620 to be greater than the depth of the receiving groove 610. It should be noted that the depth of the winding groove 620 refers to its depth in the radial direction of the main structure 600, and the depth of the receiving groove 610 refers to its depth in the radial direction of the main structure 600. It is worth explaining that after the corrugated annulus is installed on the receiving groove 610, the outer surface of the corrugated annulus is easily located outside the winding groove 620, obstructing the winding of the outer layer connecting wires and causing the winding of the outer layer connecting wires to fail. Thus, when the corrugated annulus is installed on the receiving groove 610, by setting the depth of the winding groove 620 to be greater than the depth of the receiving groove 610, the outer surface of the corrugated annulus is located inside the winding groove 620, thereby avoiding interference with the winding of the outer layer connecting wires after the corrugated annulus is installed.

[0066] Furthermore, during the demolding process, in order to reduce the pulling effect of the winding groove 620 on the inner connecting layer, such as... Figure 18 As shown, at least one sidewall of the receiving groove 610 and / or the winding groove 620 includes a guide surface structure 611. It should be noted that the guide surface structure 611 is an arc-shaped surface or an inclined surface. Therefore, during the demolding process of the tubular body 910, the inclusion of the guide surface structure 611 on at least one sidewall of the winding groove 620 and / or the receiving groove 610 along the axial direction of the main body structure 600 allows the inner connecting layer and the corrugated annular object to detach along the guide surface structure 611. This prevents the right-angled opening of the winding groove 620 from pulling on the inner connecting layer or the corrugated annular object, thus avoiding deformation of the inner connecting layer and reducing the pulling effect of the main body structure 600 on the inner connecting layer during demolding.

[0067] In other embodiments, an anti-adhesive layer is provided on the inner wall of the winding groove 620. The anti-adhesive layer can be either tin foil or aluminum foil. Thus, by providing the anti-adhesive layer, the adhesive force between the inner connecting layer and the winding groove can be reduced, thereby reducing the difficulty of the winding groove slipping off to a certain extent.

[0068] Furthermore, during the demolding process, in order to reduce the pulling force of the main structure 600 on the tubular main body 910 during demolding, such as... Figure 14 As shown, the bracket manufacturing tool includes an adjustment unit 630, which is disposed on the main structure 610 and is used to adjust the diameter of the main structure 600.

[0069] It should be noted that the main structure 600 has an opening 631, which extends through both ends of the main structure 600 along its axial direction. The opening 631 is arranged along the axial direction of the main structure 600. It can be understood that the opening 631 in the main structure 600 is one embodiment of the adjustment unit 630. The main structure 600 is a tubular structure with openings at both ends and is elastic. When the main structure 600 is subjected to a radial force, it can radially contract or expand at the opening 631. For example, in one embodiment, when it is necessary to reduce the diameter of the main structure 600, a radially inward pressure is applied from the outer wall of the main structure 600 toward the center of the main structure 600, and the opposite side walls of the opening 631 move toward each other, thereby reducing the diameter of the main structure 600; when it is necessary to increase the diameter of the main structure 600, the radially inward pressure on the outer wall of the main structure 600 is removed or reduced, and the opposite side walls of the opening 631 are reset under elastic force, thereby increasing the diameter of the main structure 600, and thus realizing the diameter adjustment of the main structure 600.

[0070] Therefore, by adjusting the diameter of the main structure 600 through the adjustment unit 630, the diameter of the main structure 600 can be reduced, and the inner connecting layer can follow the wave-shaped ring to detach, thus avoiding the winding groove 620 pulling the inner connecting layer when the wave-shaped ring comes off the main structure 600, which would cause the inner connecting layer to deform and thus cause the bracket to deform.

[0071] Furthermore, such as Figure 14 As shown, in order to prevent the main structure 600 from radially shrinking due to the pressure of the pressing device 700, the main structure 600 also includes a support member 800, which is inserted inside the main structure 600.

[0072] It should be noted that the main structure 600 is a tubular structure with openings 631 at both ends, and the support member 800 is a rod-shaped structure. The support member 800 includes a first end 810, the cross-sectional area of ​​which gradually increases from the axial end face of the support rod to the center of the support rod, thereby facilitating the insertion of the support member 800 into the main structure 600 or facilitating the extraction of the support member 800 from the main structure 600. In this way, during the heat treatment of the tubular main body 910, the support member 800, inserted into the main structure 600, can provide radial support to the main structure 600, preventing the main structure 600 from shrinking due to the pressure of the pressing component, which would cause deformation of the inner connecting layer and thus deformation of the support.

[0073] Example 4 This embodiment provides a method for manufacturing a support, such as... Figure 19 As shown, the process of manufacturing a stent using the stent manufacturing tool described above includes the following steps: S1, providing at least one connecting wire, and winding the connecting wire around the winding groove 220 to obtain an inner connecting layer; S2, the wave-shaped ring is fitted onto the main structure 210, and another connecting line is wound around the wave-shaped ring to obtain the outer connecting layer; S3, heat treatment binds the inner connecting layer, the outer connecting layer and the corrugated ring to obtain the tubular body 910; S4, adjust the diameter of the main structure 210 to make the tubular main body 910 detach.

[0074] In S1, the main structure 210 is in an expanded state. Tin foil is laid on the inner wall of the winding groove 220. The connecting wire is wound around the winding groove 220 along the contour of the winding groove 220. The connecting wire can be any one of PTFE wire, PP wire or PET wire. The connecting wires intersect to form an inner connecting layer.

[0075] In S2, the main structure 210 is in an expanded state. The wave-shaped ring is fitted onto the main structure 210, and then the wave-shaped ring is moved along the axial direction of the main structure 210, so that the wave-shaped ring is located within the receiving groove 250. The connecting wire is wound along the contour of the winding groove 220, so that the connecting wire forms an outer connecting layer on the outside of the wave-shaped ring.

[0076] In S3, a heat shrink tubing is fitted over the outer side of the outer connecting layer. The heat shrink tubing can be at least one of FEP heat shrink tubing, PTFE heat shrink tubing, and PFA heat shrink tubing. The main body structure 210 is heated to shrink the heat shrink tubing and bond the inner connecting layer and the outer connecting layer together, thereby bonding the inner connecting layer, the outer connecting layer, and the corrugated ring to form a tubular main body 910.

[0077] In step S4, after the main structure 210 cools, the sidewalls of the main structure 210 are pressed radially to shrink the opening of the main structure 210. At this point, the main structure 210 is in a contracted state, and its diameter is smaller, causing the tubular main body 910 to detach automatically for demolding. A film 920 is then placed circumferentially on the outer or inner sidewall of the tubular main body 910. The film 920 is then sewn to the tubular main body 910 at both axial ends using sutures to obtain a support. In other embodiments, the film 920 can also be sewn to the tubular main body 910 axially.

[0078] In this way, before adjusting the diameter of the main structure 210, heat treatment is performed on the corrugated annulus, the inner connecting layer, and the outer connecting layer. This allows the main structure 210 to exert radial pressure on the inner and outer connecting layers, ensuring the shaping of the inner and outer connecting layers during the heat treatment process. After the heat shaping process is completed, the diameter of the main structure 210 is adjusted to reduce its size, thereby causing the tubular main body 910 to detach on its own. This avoids the main structure 210 pulling on the inner connecting layer and causing deformation of the tubular main body 910, thus increasing the manufacturing efficiency of the bracket.

[0079] Example 5 This embodiment provides a method for manufacturing a stent, using a stent manufacturing assembly as described in any of the preceding embodiments to manufacture the stent, such as... Figure 20 As shown, it includes the following steps: S1, a tubular body 910 is provided, and the tubular body 910 is inserted into the main body structure 600; S2, the tubular body 910 is pressed onto the main structure 600 using the pressing device 700; S3, heat treatment to bond the inner and outer connecting layers on the tubular body 910; S4, remove the tubular main body 910 and sew the membrane material onto the main structure 600 to obtain the support.

[0080] In S1, the tubular body 910 includes an inner connecting layer, a corrugated ring, and an outer connecting layer. The connecting wire is wound around the winding groove 620 to obtain the inner connecting layer. The corrugated ring is sleeved on the main body structure 600, and the connecting wire is wound around the winding groove 620 with the connecting wire located outside the corrugated ring to obtain the outer connecting layer.

[0081] In S2, the first pressing member 720 and the second pressing member 730 are opened, the main structure 600 is installed in the first pressing member 720, and the second pressing member 730 is closed with the first pressing member 720, so that the outer connecting layer and the inner connecting layer are attached, and the corrugated ring is attached to the main structure 600.

[0082] In S3, the main structure 600, the first pressing member 720 and the second pressing member 730 are heated, so that the inner connecting layer and the outer connecting layer form connection points on opposite sides of the corrugated ring under the pressure of the pressing device 700, thereby bonding the inner connecting layer, the outer connecting layer and the corrugated ring to form a tubular main body 910.

[0083] In step S4, the diameter of the main structure 600 is adjusted by the adjustment unit 630 to remove the tubular main body 910. Then, the covering film 920 is disposed circumferentially on the outer or inner wall of the tubular main body 910. The covering film 920 is then sewn onto the tubular main body 910 at both axial ends using sutures to obtain a support. In other embodiments, the covering film 920 can also be sewn onto the tubular main body 910 axially.

[0084] The advantage of this setup is that by using a pressing device to compress the tubular body 910 during the heat treatment process, the inner connecting layer and the outer connecting layer can form adhesive points on opposite sides of the corrugated ring, thereby reducing the probability of the bracket manufacturing failure due to the inner connecting layer and the outer connecting layer not being connected to the corrugated ring.

[0085] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0086] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A tool for manufacturing a support, the support comprising a corrugated annulus, characterized in that, The support manufacturing tool includes a hollow main structure and an adjustment unit. The wave-shaped annular object is sleeved on the main structure, and the adjustment unit is disposed on the main structure. The adjustment unit is used to adjust the outer diameter of the main structure. The main structure is made of elastic material or shape memory metal material. Under the action of external force, the main structure can switch from an expanded state to a contracted state. When the external force is removed or a reverse external force is applied, the main structure elastically recovers and switches from the contracted state to the expanded state. The radial dimension of the main structure in the expanded state is greater than the radial dimension of the main structure in the contracted state. An opening is provided on the side wall of the main structure, and the opening extends through both ends of the main structure along its axial direction. The adjustment unit includes an adjustment mechanism, which is connected to the opposite side walls of the opening. The adjustment mechanism is used to drive the opposite side walls of the opening to move towards each other or away from each other. The adjustment mechanism includes a winding post and a connecting line. The two ends of the connecting line are connected to the opposite side walls of the opening. The connecting line is fixedly connected to the winding post. The winding post is used to drive the opposite side walls of the opening to move through the connecting line.

2. The bracket manufacturing tool according to claim 1, characterized in that, The adjustment mechanism also includes a stop, which is mounted on the winding post and located between the opposite side walls of the opening.

3. The bracket manufacturing tool according to claim 1, characterized in that, The main structure has a receiving groove on its side wall, and the side wall of the receiving groove includes a guide surface structure, which is an inclined surface or an arc surface.

4. A tool for manufacturing a support, the support comprising a corrugated annulus, characterized in that, The support manufacturing tool includes a hollow main structure and an adjustment unit. The wave-shaped annular object is sleeved on the main structure, and the adjustment unit is disposed on the main structure. The adjustment unit is used to adjust the outer diameter of the main structure. The main structure is made of elastic material or shape memory metal material. Under the action of external force, the main structure can switch from an expanded state to a contracted state. When the external force is removed or a reverse external force is applied, the main structure elastically recovers and switches from the contracted state to the expanded state. The radial dimension of the main structure in the expanded state is greater than the radial dimension of the main structure in the contracted state. An opening is provided on the side wall of the main structure, and the opening extends through both ends of the main structure along its axial direction. The adjustment unit includes a meshing structure. The opening includes a first end face and a second end face disposed opposite to each other. The meshing structure includes a protrusion and a groove. The protrusion is disposed on the first end face, and the groove is opened on the second end face. When the opening is open, the protrusion is at least partially located outside the groove. When the opening is closed, the protrusion is located inside the groove. The main structure includes a first joint and a second joint that are movably connected. The first joint and the second joint can move along the axial direction of the main structure. The first end face is located on the first joint and the second end face is located on the second joint.

5. The bracket manufacturing tool according to claim 4, characterized in that, The bracket manufacturing tool also includes a connector. The main structure has through holes at both axial ends. The through holes are at least partially located on the first joint and the second joint. The connector passes through the through holes to connect the first joint and the second joint.

6. The bracket manufacturing tool according to claim 4, characterized in that, The main structure has a receiving groove on its side wall, and the side wall of the receiving groove includes a guide surface structure, which is an inclined surface or an arc surface.

7. A method for manufacturing a stent, characterized in that, Manufacturing a stent using the stent manufacturing tool as described in any one of claims 1-6, comprising: Provide at least one connecting wire, and wrap the connecting wire around the main structure to obtain an inner connecting layer; A wave-shaped ring is installed on the outside of the main structure, and another connecting wire is wound around the wave-shaped ring to obtain an outer connecting layer; Heat treatment bonds the inner connecting layer, the corrugated annulus, and the outer connecting layer to form a tubular body; Adjust the outer diameter of the main structure to cause the tubular main body to detach.

Images