A stent manufacturing assembly and method

Abstract

The application relates to a stent manufacturing assembly and a manufacturing method. The stent manufacturing assembly comprises a main body structure and a pressing device, the main body structure is arranged in the pressing device, at least two convex structures are arranged on the inner wall of the pressing device, a containing groove is arranged on the circumferential side wall of the main body structure, and the containing groove is located between the two adjacent convex structures. Thus, the main body structure is arranged in the pressing device, the pressing device can press the wave-shaped ring on the main body structure, the inner wall of the pressing device is provided with the convex structures, the convex structures are located on the two sides of the containing groove, the inner connecting layer and the outer connecting layer can form the bonding points on the opposite sides of the wave-shaped ring, the wave-shaped ring can be covered after the inner connecting layer and the outer connecting layer are bonded, the probability that the wave-shaped ring is connected with the inner connecting layer and the outer connecting layer after being bonded is improved, and therefore the manufacturing efficiency of the stent is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a stent manufacturing assembly and a manufacturing method. BACKGROUND

[0002] This section provides background information only and can not necessarily be prior art.

[0003] In the process of manufacturing a covered stent, a wave-shaped ring is mounted on a main structure, and then the inner connecting layer and the outer connecting layer on both sides of the wave-shaped ring are hot-pressed and bonded. Since the mounting member is usually in a mesh shape, the inner connecting layer and the outer connecting layer are easily bonded at the same side of the wave-shaped ring by hot-pressing and bonding the inner connecting layer and the connecting layer with the heat-shrinkable film, thereby causing the inner connecting layer and the outer connecting layer to be difficult to connect with the wave-shaped ring, and further causing the stent manufacturing to fail. SUMMARY

[0004] Therefore, it is necessary to provide a stent manufacturing assembly, which comprises a main structure and a pressing device, the main structure is arranged in the pressing device, at least two protruding structures are arranged on the inner wall of the pressing device, a receiving groove is arranged on the circumferential side wall of the main structure, and the receiving groove is located between the adjacent two protruding structures.

[0005] Optionally, the pressing device comprises a first pressing member and a second pressing member arranged along the circumference of the main structure, and the protruding structure is arranged on the inner wall of the first pressing member and the second pressing member close to the main structure.

[0006] Optionally, the first pressing member and / or the second pressing member comprises a shell part, an elastic part and a pressing part, the two ends of the elastic part are connected with the pressing part and the shell part respectively, and the protruding structure is arranged on the pressing part.

[0007] Optionally, a winding groove is arranged on the main structure, the winding groove is in a first wave-shaped structure, the receiving groove is in a second wave-shaped structure, the wave shapes of the first wave-shaped structure and the second wave-shaped structure have a phase difference, and the protruding structures are arranged along the contour of the first wave-shaped structure at intervals.

[0008] Optionally, the groove depth of the winding groove is greater than the groove depth of the receiving groove.

[0009] Optionally, the side wall of the receiving groove comprises a guide surface structure, and the guide surface structure is an arc surface or an inclined surface.

[0010] Optionally, the stent manufacturing assembly comprises an adjusting unit arranged on the main structure, the main structure is a hollow structure, and the adjusting unit is used for adjusting the outer diameter of the main structure.

[0011] Optionally, an opening is arranged on the main structure, and the opening penetrates through both ends of the main structure along the axial direction of the main structure.

[0012] Optionally, the stent manufacturing assembly comprises a support, the support is arranged in the main body structure, and the support provides radial support force for the main body structure when the main body structure is subjected to the pressure of the pressing device.

[0013] Compared with the prior art, the stent manufacturing assembly has the beneficial effects that:

[0014] The main body structure is arranged in the pressing device, so that the pressing device can press the wave-shaped ring on the main body structure, the protruding structure is arranged on the inner wall of the pressing device and located on both sides of the accommodating groove, the inner connecting layer and the outer connecting layer can form bonding points on opposite sides of the wave-shaped ring, so that the inner connecting layer and the outer connecting layer can be wrapped after bonding, and the probability of connection between the inner connecting layer, the outer connecting layer and the wave-shaped ring after bonding is improved, thereby increasing the manufacturing efficiency of the stent.

[0015] The application further provides a stent manufacturing method, the stent comprising a tubular main body, the tubular main body comprising an inner connecting layer, an outer connecting layer and a wave-shaped ring, the stent is manufactured by using the above stent manufacturing assembly, and the method comprises the following steps: sequentially arranging the inner connecting layer, the wave-shaped ring and the outer connecting layer on the main body structure; sleeving the pressing device on the main body structure, so that the pressing device presses the inner connecting layer and the outer connecting layer; performing heat treatment to bond the inner connecting layer, the wave-shaped ring and the outer connecting layer to obtain the tubular main body; and dismounting the tubular main body from the main body structure. BRIEF DESCRIPTION OF DRAWINGS

[0016] Figure 1 It is a structural schematic view of the stent in the embodiment of the application;

[0017] Figure 2 It is a structural schematic view of the stent manufacturing assembly in the first embodiment of the application;

[0018] Figure 3 It is an axonometric view of the main body structure in the first embodiment of the application;

[0019] Figure 4 It is an unfolded structural schematic view of the main body structure in the first embodiment of the application;

[0020] Figure 5 It is an enlarged structural schematic view of A in the first embodiment of the application; Figure 2

[0021] Figure 6 It is a structural schematic view of the winding post driving the connecting line to move in the first embodiment of the application;

[0022] Figure 7 It is an enlarged structural schematic view of B in the first embodiment of the application; Figure 2

[0023] ​​Figure 8 This is a schematic diagram of the structure of the support manufacturing assembly in Embodiment 2 of the present invention;

[0024] Figure 9 This is a top view of the main structure in Embodiment 2 of the present invention;

[0025] Figure 10 This is a schematic diagram of the structure of the first and second joints in Embodiment 2 of the present invention;

[0026] Figure 11 This is another structural schematic diagram of the first and second joint portions in Embodiment 2 of the present invention;

[0027] Figure 12 For the present invention Figure 8 A schematic diagram of the cross-sectional structure at point AA;

[0028] Figure 13 This is a top view of the support manufacturing assembly in Embodiment 3 of the present invention;

[0029] Figure 14 This is a front view of the support manufacturing assembly in Embodiment 3 of the present invention;

[0030] Figure 15 For the present invention Figure 14 Enlarged schematic diagram of the structure at point C;

[0031] Figure 16 This is an exploded view of the support manufacturing assembly in Embodiment 3 of the present invention;

[0032] Figure 17 This is a cross-sectional structural diagram of the support manufacturing assembly in Embodiment 3 of the present invention;

[0033] Figure 18 For the present invention Figure 14 A schematic diagram of the cross-sectional structure at point BB;

[0034] Figure 19 This is a flowchart of the support manufacturing method in Embodiment 4 of the present invention;

[0035] Figure 20 This is a flowchart of the support manufacturing method in Embodiment 5 of the present invention. Detailed Implementation

[0036] In order to make the above objectives, features and advantages of the present application more clear and comprehensible, specific embodiments of the present application are described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in a number of different ways from those described herein without departing from the scope of the present application and it is understood that variations can be made in view of what is described and understood in the field of the technologies to which the present application pertains. Therefore, the present application is not limited to the specific embodiments described below.

[0037] 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 application belongs. The terminology used in the description herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application.

[0038] Embodiment One

[0039] The present embodiment provides a stent manufacturing tool 100, as shown in Figures 1 to 4 including a main body structure 110 and an adjusting unit 130, the adjusting unit 130 is arranged on the main body structure 110, and the adjusting unit 130 is used to adjust the outer diameter of the main body structure 110.

[0040] As shown in Figure 1 , the stent 900 includes a tubular body 910 and a covering film 920, the covering film 920 is sutured on the tubular body 910, and the tubular body 910 includes an inner connecting layer, a wave-shaped ring and an outer connecting layer. The inner connecting layer, the wave-shaped ring and the outer connecting layer are bonded, and the inner connecting layer and the outer connecting layer are used to connect a plurality of wave-shaped rings. The present embodiment does not limit the shape of the inner connecting layer and the outer connecting layer, and specifically, the inner connecting layer and the outer connecting layer can be in a mesh structure or a line structure.

[0041] As shown in Figure 2 , Figure 3 , the main body structure 110 is a tubular structure with both ends open or a hollow structure with both ends open, and the main body structure 110 is made of an elastic material or a memory metal material, and specifically, can be stainless steel or nickel-titanium alloy. The present embodiment does not limit the shape of the cross section of the main body structure 110, for example, the cross section of the main body structure 110 can be circular or elliptical.

[0042] 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.

[0043] 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 3 As 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.

[0044] 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.

[0045] 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.

[0046] The advantage of the arrangement is that the installation groove 120 is arranged on the main structure 110 in a preset shape, so that the wave-shaped ring can be accommodated in the accommodation groove 160. After the inner connecting layer and the wave-shaped ring are heat-welded, the diameter of the main structure 110 is adjusted by the adjusting unit 130, so that the diameter of the main structure 110 is reduced, thereby causing the wave-shaped ring to fall off by itself. This avoids the need for manual removal of the tubular main body 910, which can cause the inner connecting layer and the outer connecting layer to be pulled and deformed.

[0047] Further, in order to facilitate adjustment of the interval distance d2 between the opposite side walls of the opening 131, the adjusting unit 130 further comprises an adjusting mechanism 140 connected to the opposite side walls of the opening 131, and the adjusting mechanism 140 is configured to drive the opposite side walls of the opening 131 to move towards or away from each other. Figure 2

[0048] In this embodiment, as shown in Figure 2 , Figure 5 The adjusting mechanism 140 comprises a winding column 141 and a connecting wire 142. The two ends of the connecting wire 142 are connected to the opposite side walls of the opening 131, and the connecting wire 142 is wound on the winding column 141 and fixedly connected to the winding column 141. Specifically, the two ends of the connecting wire 142 are welded to the opposite side walls of the opening 131, and the connecting wire 142 is wound on the winding column 141. In other embodiments, a connecting lug is arranged on the opposite side walls of the opening 131, a connecting hole is arranged on the connecting lug, and the connecting wire 142 is wound on the connecting lug. In other embodiments, the connecting wire 142 comprises a first connecting portion and a second connecting portion. The two ends of the first connecting portion are respectively welded to one side wall of the opening 131 and the winding column 141, and the two ends of the second connecting portion are respectively welded to the other side wall of the opening 131 and the winding column 141.

[0049] In one embodiment, as shown in Figure 6 When it is necessary to reduce the diameter of the main structure 110, the winding column 141 is rotated to pull the connecting wire 142, which drives 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 winding column 141 is rotated to loosen the connecting wire 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 achieving adjustment of the diameter of the main structure 110.

[0050] ​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 body structure 110, the driving end of the adjusting mechanism 140 abuts against the inner wall of the main body structure 110, and the movement direction of the driving end of the adjusting mechanism 140 is parallel to the movement direction of the opposite two side walls of the opening 131. When it is needed to increase the diameter of the main body structure 110, the driving end of the adjusting mechanism 140 pushes the inner wall of the main body structure 110 to move, so that the opposite two side walls of the opening 131 move away from each other, thereby increasing the diameter of the main body structure 110; when it is needed to decrease the diameter of the main body structure 110, the driving end of the adjusting mechanism 140 is retracted, so that the opposite two side walls of the opening 131 move towards each other, thereby decreasing the diameter of the main body structure 110, and the diameter adjustment of the main body structure 110 is realized.

[0051] Therefore, when it is needed to remove the tubular main body 910, the opposite two side walls of the opening 131 are moved towards or away from each other by the adjusting mechanism 140, the diameter adjustment of the main body structure 110 is realized, and the tubular main body 910 can be automatically removed, thereby avoiding the interference of the staff pressing the side wall of the main body structure 110 to the removal of the tubular main body 910.

[0052] Further, as shown in Figure 2 and Figure 7 , in order to avoid the excessive contraction of the opening 131, the bracket manufacturing tool further comprises a stopper 150, which is installed on the winding column 141 and located between the opposite two side walls of the opening 131.

[0053] In the embodiment, a connecting hole is formed in the stopper 150, an internal thread is formed in the connecting hole, an external thread is formed in the axial one end of the winding column 141, and the winding column 141 is threadedly matched with the stopper 150. In other embodiments, the stopper 150 can also be welded or clamped with the winding column 141. Therefore, in the process of moving the opposite two side walls of the opening 131 towards each other by the adjusting mechanism 140, the stopper 150 is located between the opposite two side walls of the opening 131, so that the stopper 150 can stop the movement of the opposite two side walls of the opening 131, thereby avoiding the excessive contraction of the opening 131 and the failure of the main body structure 110 exceeding the elastic deformation limit.

[0054] Embodiment Two

[0055] The embodiment provides a bracket manufacturing tool 200, and the difference between the embodiment and the embodiment one is that, as shown in Figure 8 , Figure 9 , the adjusting unit 230 comprises engagement structures 232, which are respectively arranged on the opposite two side walls of the opening 231, and the engagement structures 232 are used for switching the main body structure 210 between the expanded state and the contracted state.

[0056] It should be noted that the opening 231 is open when the main body structure 210 is in the expanded state, and the opening 231 is closed when the main body structure 210 is in the contracted state. In the embodiment, as shown in the figure, the opening 231 comprises a first end surface and a second end surface arranged oppositely, and the engagement structure 232 comprises a protrusion 2321 and a groove 2322, the protrusion 2321 is arranged on the first end surface, and the groove 2322 is arranged on the second end surface. Figure 10 As shown in the figure, when the main body structure 210 is in the expanded state, the protrusion 2321 is at least partially located outside the groove 2322. Figure 9 As shown in the figure, when the main body structure 210 is in the expanded state, the protrusion 2321 is at least partially located outside the groove 2322. Figure 10 As shown in the figure, when the main body structure 210 is in the expanded state, the protrusion 2321 is at least partially located outside the groove 2322.

[0057] In this way, during the adjustment of the diameter of the main body structure 210, the relative axial movement of the opening 231 and the two side walls can switch the main body structure 210 between the expanded state and the contracted state, avoiding the need for the staff to press the main body structure 210 from the side wall of the main body structure 210 in the radial direction, which interferes with the shedding of the wave-shaped ring and the inner connecting layer.

[0058] Further, as shown in the figure, in order to facilitate the axial relative movement of the first side wall and the second side wall, the main body structure 210 comprises a first joint part 211 and a second joint part 212 which are attached to each other, the first joint part 211 and the second joint part 212 can move along the axial direction of the main body structure 210, the first side wall is located on the first joint part 211, and the second side wall is located on the second joint part 212. Figures 8 to 11 It should be noted that, as shown in the figure, the side end surfaces of the first joint part 211 and the second joint part 212 are attached to each other to form the main body structure 210, the first joint part 211 and the second joint part 212 can move along the axial direction of the main body structure 210, the moving direction of the first joint part 211 and the second joint part 212 can be the same or opposite, the engagement structure 232 comprises a first engagement structure 233 and a second engagement structure 234, the first engagement structure 233 is located on the first edge of the first joint part 211 and the second joint part 212 which are attached to each other, and the second engagement structure 234 is located on the second edge of the first joint part 211 and the second joint part 212 which are attached to each other.

[0059] Figure 9 In an embodiment, as shown in the figure, the first joint part 211 and the second joint part 212 can move along the axial direction of the main body structure 210 in the same direction.

[0060] In an embodiment, as shown in the figure, the first joint part 211 and the second joint part 212 can move along the axial direction of the main body structure 210 in the same direction. Figure 10 ​As shown in FIG. 1, when the tubular body 910 needs to be demolded, the body structure 210 is switched from the expanded state to the contracted state, the first joint 211 is pushed to move in the first direction f1, the second joint 212 is pushed to move in the second direction f2, the first direction f1 and the second direction f2 are parallel and opposite, the protrusion 2321 engages with the groove 2322, the diameter of the body structure 210 is reduced, and the tubular body 910 is demolded, thereby achieving the demolding of the tubular body 910. Figure 10 As shown in FIG. 1, when the tubular body 910 needs to be demolded, the body structure 210 is switched from the expanded state to the contracted state, the first joint 211 is pushed to move in the first direction f1, the second joint 212 is pushed to move in the second direction f2, the first direction f1 and the second direction f2 are parallel and opposite, the protrusion 2321 engages with the groove 2322, the diameter of the body structure 210 is reduced, and the tubular body 910 is demolded, thereby achieving the demolding of the tubular body 910.

[0061] Thus, by comprising the first joint 211 and the second joint 212, the first joint 211 and the second joint 212 can move in the axial direction of the body structure 210, so that the worker can push the first joint 211 and the second joint 212 in the axial direction to switch the body structure 210 between the expanded state and the contracted state, thereby reducing the operation difficulty of demolding.

[0062] Further, as shown in FIG. 1, in order to facilitate the installation of the first joint 211 and the second joint 212, the support manufacturing tool further comprises a connecting piece 240, and an axial end of the body structure 210 is provided with a through hole 213, and the connecting piece 240 is arranged in the through hole 213 to connect the first joint 211 and the second joint 212. Figure 8 、 Figure 9 As shown in FIG. 1, in order to facilitate the installation of the first joint 211 and the second joint 212, the support manufacturing tool further comprises a connecting piece 240, and an axial end of the body structure 210 is provided with a through hole 213, and the connecting piece 240 is arranged in the through hole 213 to connect the first joint 211 and the second joint 212.

[0063] In this embodiment, the through hole 213 penetrates through both axial ends of the body structure 210 in the axial direction of the body structure 210, and the through hole 213 is at least partially located on the first joint 211 and the second joint 212. The connecting piece 240 comprises a connecting shaft 241 and at least two limit pieces 242, the connecting shaft 241 is inserted into the through hole 213, the axial ends of the connecting shaft 241 are provided with external threads, the limit pieces 242 are provided with threaded holes, and the limit pieces 242 are threadedly connected with the connecting shaft 241 to tighten the first joint 211 and the second joint 212. The limit pieces 242 comprise a first limit piece 2421 and a second limit piece 2422, the first limit piece 2421 is connected with one end of the connecting shaft 241, and the second limit piece 2422 is connected with the other end of the connecting shaft 241.

[0064] Thus, when the main body 210 is in the expanded state, the axial ends of the first and second connecting portions 211 and 212 are parallel, and the connecting member 240 is tightened to prevent the first and second connecting portions 211 and 212 from being displaced during the winding of the connecting wire or the installation of the wave-shaped ring. When it is necessary to remove the tubular main body 910, the connecting member 240 is loosened, and the first and second connecting portions 211 and 212 are pushed to move axially relative to each other, so that the tubular main body 910 is removed by itself.

[0065] Further, as shown in Figure 8 , Figure 12 In order to reduce the pulling effect of the main body 210 on the inner connecting layer and the wave-shaped ring during the removal process, at least one side wall of the accommodating groove 250 and / or the winding groove 220 includes a guide surface structure 260, which is an arc surface or an inclined surface.

[0066] It should be noted that the accommodating groove 250 is used to accommodate the wave-shaped ring, and the profile of the accommodating groove 250 corresponds to the profile of the wave-shaped ring. The accommodating groove 250 is arranged along the circumference of the main body 210. The accommodating groove 250 includes a first side wall and a second side wall, which are arranged opposite to each other, and the guide surface structure 260 is arranged on the first side wall and / or the second side wall. The guide surface structure 260 can be an arc surface structure or an inclined surface structure. The guide surface structure 260 can also be arranged on the side wall of the winding groove 220, which is used to accommodate the connecting wire.

[0067] In this way, during the removal of the tubular main body 910, the guide surface structure 260 arranged on the side wall of the accommodating groove 250 and / or the winding groove 220 allows the inner connecting layer and the wave-shaped ring to be removed along the guide surface structure 260, so that the removal of the inner connecting layer is smoother, and the deformation of the inner connecting layer caused by the pulling of the side wall of the main body 110 is avoided.

[0068] In other embodiments, an anti-adhesion layer is arranged on the inner wall of the winding groove 220. The anti-adhesion layer can be any one of a tin foil or an aluminum foil. In this way, the arrangement of the anti-adhesion layer can reduce the adhesion between the inner connecting layer and the winding groove 220, thereby reducing the difficulty of the inner connecting layer sliding out of the winding groove 220.

[0069] Embodiment Three

[0070] This embodiment provides a stent manufacturing assembly, as shown in Figures 13 to 16 which includes a main body 600 and a pressing device 700. The main body 600 is arranged in the pressing device 700. The inner wall of the pressing device 700 is provided with at least two protruding structures 710. The outer side wall of the main body 600 is provided with an accommodating groove 610, which is located between the adjacent two protruding structures 710.

[0071] As shown in Figure 14 , Figure 15 , the main structure 600 is used for loading the inner connection layer, the wave-shaped ring and the outer connection layer. The side wall of the main structure 600 is provided with a receiving groove 610, the profile of the receiving groove 610 corresponds to the profile of the wave-shaped ring, and the wave-shaped ring is received in the receiving groove 610. The outer side wall of the main structure 600 is also provided with a winding groove 620, the winding groove 620 is used for receiving the connecting wire, the connecting wire intersects on the inner side of the wave-shaped ring to form the inner connection layer, and the connecting wire intersects on the outer side of the wave-shaped ring to form the outer connection layer.

[0072] As shown in Figure 16 , the pressing device 700 includes a first pressing member 720 and a second pressing member 730 which are arranged circumferentially along the main structure 600, the first pressing member 720 and the second pressing member 730 are detachably connected, and the convex structure 710 is located on the inner wall of the first pressing member 720 and the second pressing member 730.

[0073] In this embodiment, the first pressing member 720 includes a first connecting lug 722, the second pressing member 730 includes a second connecting lug 732, a first connecting hole is formed on the first connecting lug 722, a second connecting hole is formed on the second connecting lug 732, and a fastener is arranged on the first connecting hole and the second connecting hole to realize the connection of the first pressing member 720 and the second pressing member 730. The pressing device 700 includes a first state in which the tubular main body 910 is pressed on the main structure 600 and a second state in which the tubular main body 910 is loosened. Thus, the first pressing member 720 and the second pressing member 730 are detachably connected, the first pressing member 720 and the second pressing member 730 can be closed to make the pressing member in the first state, and the first pressing member 720 and the second pressing member 730 are opened to make the pressing member in the second state, so as to realize the opening and closing of the pressing device 700 and facilitate the disassembly and assembly of the tubular main body 910.

[0074] In other embodiments, the first pressing member 720 and the second pressing member 730 are in arc-shaped structure and coaxially arranged, one end of the first pressing member 720 and the second pressing member 730 is hinged or shaft hole connected, and the other end of the first pressing member 720 and the second pressing member 730 is screw connected or clamped, and the first pressing member 720 can be rotated to open or close relative to the second pressing member 730.

[0075] The convex structure 710 is located on the inner wall of the first pressing member 720 and the second pressing member 730, the convex structure 710 is multiple, the multiple convex structures 710 can be circumferentially arranged at equal intervals or non-equal intervals, the convex structure 710 is located on the opposite sides of the receiving groove 610, and the convex structure 710 is used for pressing the inner connection layer and the outer connection layer when the first pressing member 720 and the second pressing member 730 are closed.

[0076] In one embodiment, during the heat treatment of the tubular body 910, the pressing device 700 is in the first state, at this time, as shown in FIG. 7A, the first pressing member 720 and the second pressing member 730 enclose the mounting space of the body structure 600, the body structure 600 is arranged in 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 on the body structure 600, and the wave-shaped ring is located between two adjacent protruding structures 710; after the heat treatment of the tubular body 910 is completed, 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 body structure 600 is taken out, so as to demold the tubular body 910. Figure 13

[0077] It is worth explaining that in the embodiment, the inner connecting layer and the outer connecting layer play a role in connecting the wave-shaped ring, the inner connecting layer and the outer connecting layer are in a mesh structure, at this time, if the bonding points of the inner connecting layer and the outer connecting layer are not on the opposite sides of the wave-shaped ring, the connection between the inner connecting layer, the outer connecting layer and the wave-shaped ring will fail.

[0078] Therefore, by arranging the body structure 600 in the pressing device 700, the pressing device 700 can press the wave-shaped ring on the body structure 600, by arranging the protruding structure 710 on the inner wall of the pressing device 700, the protruding structure 710 is located on the two sides of the accommodating groove 610, so that the inner connecting layer and the outer connecting layer can form bonding points on the opposite sides of the wave-shaped ring, so that the inner connecting layer and the outer connecting layer can wrap the wave-shaped ring after being bonded, thereby improving the connection probability of the inner connecting layer, the outer connecting layer and the wave-shaped ring after being bonded, thereby increasing the manufacturing efficiency of the stent.

[0079] Further, in order to increase the connection tightness of the inner connecting layer and the outer connecting layer after heat treatment, as shown in FIG. 7B, the first pressing member 720 and / or the second pressing member 730 of the embodiment further comprises a shell part, an elastic part and a pressing part, the two ends of the elastic part are connected with the pressing part and the shell part respectively, and the protruding structure 710 is arranged on the pressing part. Figure 16

[0080] ​​It should be noted that the first pressing member 720 comprises a first housing portion 723, a first elastic portion 724 and a first pressing portion 725, both ends of the first elastic portion 724 are welded with the first housing portion 723 and the first pressing portion 725 respectively, the first elastic portion 724 has elasticity and variable length; the second pressing member 730 comprises a second housing portion 733, a second pressing portion 735 and a second elastic portion 734, both ends of the second elastic portion 734 are welded with the second housing portion 733 and the second pressing portion 735 respectively, the second elastic portion 734 has elasticity and variable length; wherein the first housing portion 723 and the second housing portion 733 are screw connected, the side end faces of the first housing portion 723 and the second housing portion 733 are attached, the first elastic portion 724, the first pressing portion 725, the second elastic portion 734 and the second pressing portion 735 are located at the inner side of the first housing portion 723 and the second housing portion 733, the first pressing portion 725 and the second pressing portion 735 are arc-shaped structures and oppositely arranged, the first pressing portion 725 and the second pressing portion 735 enclose a tubular structure, and the diameter of the tubular structure is smaller than the diameter of the main body structure 600.

[0081] In one embodiment, when the pressing device 700 is in the first state, the first pressing portion 725 presses the outer connecting layer to the inner connecting layer under the elastic action of the first elastic portion 724, and the second pressing portion 735 presses the outer connecting layer to the inner connecting layer under the elastic action of the second elastic portion 734; when the pressing device 700 is in the second state, the pressing device 700 is opened, and the first pressing portion 725 and the second pressing portion 735 loosen the main body structure 600.

[0082] It is worth explaining that, in order to make the tubular structure formed by the first pressing portion 725 and the second pressing portion 735 can accommodate the main body structure 600, the inner diameter of the tubular structure must be greater than the diameter of the main body structure 600, in this case, there must be a gap between the main body structure 600 and the first pressing portion 725 and the second pressing portion 735, during the heat treatment process, the inner connecting layer and the outer connecting layer lack a certain pressure, which is easy to produce gap or bubble and reduce the stability of the inner connecting layer and the outer connecting layer after bonding.

[0083] Therefore, by connecting both ends of the elastic portion with the pressing portion and the housing portion respectively, the elastic portion can provide radial pressure for the pressing portion, so that the pressing portion can press the inner connecting layer and the outer connecting layer tightly, and the inner connecting layer and the outer connecting layer can be tightly bonded after heat treatment.

[0084] Further, in order to facilitate the winding forming of the inner connecting layer and the outer connecting layer, such as Figure 14 、 Figure 15 and Figure 17As 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.

[0085] 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.

[0086] like Figure 17 As shown, the protruding structure 710 is arranged along the contour of the winding groove 620. Figure 17 The dashed line represents the outline of the winding groove 620 and the receiving groove 610, and there is a gap between two 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.

[0087] 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.

[0088] Further, in order to facilitate the winding of the outer connection line, the embodiment also limits the groove depth of the winding groove 620 to be greater than the groove depth of the accommodating groove 610. It should be noted that the groove depth of the winding groove 620 refers to the groove depth of the winding groove 620 in the radial direction of the main body structure 600, and the groove depth of the accommodating groove 610 refers to the groove depth of the accommodating groove 610 in the radial direction of the main body structure 600. It is worth explaining that after the wave-shaped ring is installed on the accommodating groove 610, the outer surface of the wave-shaped ring is easy to be located outside the winding groove 620, which forms an obstruction to the winding of the outer connection line, resulting in the failure of the winding of the outer connection line. In this way, after the wave-shaped ring is installed on the accommodating groove 610, by setting the groove depth of the winding groove 620 to be greater than the groove depth of the accommodating groove 610, the outer surface of the wave-shaped ring is located inside the winding groove 620, thereby avoiding the interference of the wave-shaped ring after installation with the winding of the outer connection line.

[0089] Further, in the demolding process, in order to reduce the pulling of the inner connection layer by the winding groove 620, as shown in Figure 18 At least one side wall of the accommodating 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 surface or an inclined surface. Thus, in the demolding process of the tubular main body 910, by setting the at least one side wall of the winding groove 620 and / or the accommodating groove 610 in the axial direction of the main body structure 600 to include the guide surface structure 611, the inner connection layer and the wave-shaped ring can be dropped along the guide surface structure 611, avoiding the pulling of the inner connection layer or the wave-shaped ring by the right-angled opening of the winding groove 620 to cause the deformation of the inner connection layer, and reducing the pulling effect of the main body structure 600 on the inner connection layer in the demolding process.

[0090] In other embodiments, a release layer is provided on the inner wall of the winding groove 620. The release layer can be any one of a tin foil or an aluminum foil. In this way, by setting the release layer, the adhesion between the inner connection layer and the winding groove can be reduced, thereby to a certain extent reducing the difficulty of the sliding of the winding groove.

[0091] Further, in the demolding process, in order to reduce the pulling of the tubular main body 910 by the main body structure 600 in the demolding process of the tubular main body 910, as shown in Figure 14 The support manufacturing tool includes an adjusting unit 630, which is provided on the main body structure 610 and is used to adjust the diameter of the main body structure 600.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] Example 4

[0097] 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:

[0098] S1, providing at least one connecting line, winding the connecting line on the winding groove 220 to obtain an inner connecting layer;

[0099] S2, sleeving a wave-shaped ring on the main structure 210, winding another connecting line on the wave-shaped ring to obtain an outer connecting layer;

[0100] S3, heat treatment to bond the inner connecting layer, the outer connecting layer and the wave-shaped ring to obtain a tubular main body 910;

[0101] S4, adjusting the diameter of the main structure 210 to make the tubular main body 910 fall off.

[0102] In S1, the main structure 210 is in an expanded state, the tin foil is laid on the inner wall of the winding groove 220, the connecting line is wound in the winding groove 220 along the contour of the winding groove 220, the connecting line can be any one of PTFE line, PP line or PET line, and the connecting lines intersect to obtain an inner connecting layer.

[0103] In S2, the main structure 210 is in an expanded state, the wave-shaped ring is sleeved on the main structure 210, and then the wave-shaped ring is moved along the axial direction of the main structure 210 to be located in the accommodating groove 250. The connecting line is wound along the contour of the winding groove 220 to form an outer connecting layer outside the wave-shaped ring.

[0104] In S3, a heat shrink tube is sleeved outside the outer connecting layer, the heat shrink tube can be at least one of FEP heat shrink tube, PTFE heat shrink tube and PFA heat shrink tube, the main structure 210 is heated to make the heat shrink tube shrink to bond the inner connecting layer and the outer connecting layer with each other, so that the inner connecting layer, the outer connecting layer and the wave-shaped ring are bonded to form a tubular main body 910.

[0105] In S4, after the main structure 210 is cooled, the side wall of the main structure 210 is pressed in the radial direction, and the opening of the main structure 210 is contracted. At this time, the main structure 210 is in a contracted state, the diameter of the main structure 210 is smaller, and the tubular main body 910 is automatically separated to realize demolding. The film 920 is arranged on the outer side wall or the inner side wall of the tubular main body 910 along the circumferential direction of the tubular main body 910, and the film 920 is sewn on the tubular main body 910 at both axial ends of the tubular main body 910 by using a suture line to obtain a stent. In other embodiments, the film 920 can also be sewn on the tubular main body 910 along the axial direction of the tubular main body.

[0106] Thus, before adjusting the diameter of the main body structure 210, the wave-shaped ring, the inner connecting layer and the outer connecting layer are heat-treated, so that the main body structure 210 forms radial pressure on the inner connecting layer and the outer connecting layer, ensuring the setting of the inner connecting layer and the outer connecting layer during the heat treatment, and after the heat setting treatment, the diameter of the main body structure 210 is adjusted to be reduced, so that the tubular body 910 is automatically separated from the main body structure 210, avoiding the deformation of the tubular body 910 caused by the pulling of the main body structure 210 on the inner connecting layer, and increasing the manufacturing efficiency of the stent.

[0107] Embodiment Five

[0108] The embodiment provides a stent manufacturing method for manufacturing the stent by using the stent manufacturing assembly according to any one of the above embodiments, such as Figure 20 as shown, comprising the following steps:

[0109] S1, providing a tubular body 910, and arranging the tubular body 910 on the main body structure 600;

[0110] S2, using the pressing device 700 to press the tubular body 910 on the main body structure 600;

[0111] S3, heat-treating to bond the inner connecting layer and the outer connecting layer on the tubular body 910;

[0112] S4, removing the tubular body 910, and sewing the film material on the main body structure 600 to obtain the stent.

[0113] In S1, the tubular body 910 includes the inner connecting layer, the wave-shaped ring and the outer connecting layer, the connecting wire is wound in the winding groove 620 to obtain the inner connecting layer, the wave-shaped ring is sleeved on the main body structure 600, and the connecting wire is wound on the winding groove 620 and located outside the wave-shaped ring to obtain the outer connecting layer.

[0114] In S2, the first pressing part 720 and the second pressing part 730 are opened, the main body structure 600 is arranged in the first pressing part 720, and the second pressing part 730 is closed to the first pressing part 720, so that the outer connecting layer is attached to the inner connecting layer, and the wave-shaped ring is attached to the main body structure 600.

[0115] In S3, the main body structure 600, the first pressing part 720 and the second pressing part 730 are heated to form connecting points on the opposite sides of the wave-shaped ring under the pressure of the pressing device 700, so that the inner connecting layer, the outer connecting layer and the wave-shaped ring are bonded to form the tubular body 910.

[0116] In S4, the diameter of the main body structure 600 is adjusted by the adjusting unit 630, the tubular main body 910 is unloaded, and then the covering film 920 is arranged on the outer sidewall or the inner sidewall of the tubular main body 910 in the circumferential direction of the tubular main body 910. The covering film 920 is sewn on the tubular main body 910 at both axial ends of the tubular main body 910 by using a sewing thread to obtain a stent. In other embodiments, the covering film 920 can also be sewn on the tubular main body 910 in the axial direction of the tubular main body 910.

[0117] The advantage of such an arrangement is that, by pressing the tubular main body 910 by using the pressing device during the heat treatment, the inner connecting layer and the outer connecting layer can form adhesive points on the opposite sides of the wave-shaped ring, thereby reducing the probability of failure of the stent manufacturing caused by the fact that the inner connecting layer and the outer connecting layer are not connected to the wave-shaped ring.

[0118] The technical features of the above-described embodiments can be combined in any manner. For the sake of brevity, not all possible combinations of the technical features in the above-described embodiments are described, however, as long as the combinations of the technical features do not contradict each other, they should be considered as falling within the scope of the present disclosure.

[0119] The above-described embodiments only express several embodiments of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be noted that, for those skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are all within the scope of the present application. Therefore, the scope of protection of the present application should be subject to the appended claims.

Claims

1. A stent manufacturing assembly, comprising: The stent manufacturing assembly comprises a main body structure and a pressing device, the main body structure is arranged in the pressing device, at least two protruding structures are arranged on the inner wall of the pressing device, and a receiving groove is arranged on the circumferential side wall of the main body structure and located between two adjacent protruding structures; A winding groove is arranged on the main body structure, the winding groove is a first wave structure, the receiving groove is a second wave structure, the wave structures of the first wave structure and the second wave structure have a phase difference, and the protruding structures are arranged along the contour of the first wave structure.

2. The stent manufacturing assembly of claim 1, wherein, The pressing device comprises a first pressing member and a second pressing member arranged circumferentially on the main body structure, and the protruding structures are arranged on the inner wall of the first pressing member and the second pressing member close to the main body structure.

3. The stent manufacturing assembly of claim 2, wherein, The first pressing member and / or the second pressing member comprises a shell part, an elastic part and a pressing part, the two ends of the elastic part are connected with the pressing part and the shell part respectively, and the protruding structures are arranged on the pressing part.

4. The stent manufacturing assembly of claim 1, wherein, The depth of the winding groove is greater than the depth of the receiving groove.

5. The stent manufacturing assembly of claim 1, wherein, The side wall of the receiving groove comprises a guide surface structure, which is an arc surface or an inclined surface.

6. The stent manufacturing assembly of claim 1, wherein, The stent manufacturing assembly comprises an adjusting unit arranged on the main body structure, the main body structure is a hollow structure, and the adjusting unit is used for adjusting the outer diameter of the main body structure.

7. The stent manufacturing assembly of claim 6, wherein, An opening is arranged on the main body structure, and the opening penetrates through both ends of the main body structure along the axial direction of the main body structure.

8. The stent manufacturing assembly of claim 6, wherein, The stent manufacturing assembly comprises a support arranged in the main body structure, and the support provides radial support for the main body structure when the main body structure is subjected to the pressure of the pressing device.

9. A stent manufacturing method, the stent comprising a tubular body comprising an inner connecting layer, an outer connecting layer and a wave-like ring, characterized in that, The stent is manufactured by using the stent manufacturing assembly according to any one of claims 1-8, comprising: The inner connecting layer, the wave-shaped ring and the outer connecting layer are sequentially arranged on the main body structure; The pressing device is arranged on the main body structure, and the pressing device presses the inner connecting layer and the outer connecting layer; Heat treatment is performed to bond the inner connecting layer, the wave-shaped ring and the outer connecting layer to obtain a tubular main body; The tubular main body is removed from the main body structure.

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