Film-covered tube shaping device and shaping method, and film-covered stent preparation method

Abstract

The present invention provides a film-covered tube shaping device and shaping method, and a film-covered stent preparation method, wherein the film-covered tube shaping device comprises a main tube section, at least two bifurcated tube sections, and at least two branch tube sections; the main tube section is detachably connected to the proximal ends of at least two bifurcated tube sections; the distal end of each bifurcated tube section is detachably connected to the proximal end of one branch tube section. With such a configuration, the film-covered tube shaping device comprises three parts, namely, the main tube section, the bifurcated tube section, and the branch tube section, and the three parts can be respectively placed in the main body section, the bifurcated section, and the branch section of the bifurcated film-covered tube, and each part can be respectively adapted to each part of the bifurcated film-covered tube, thereby reducing the risk of the bifurcated film-covered tube being torn during the shaping process, improving the qualified rate of the bifurcated film-covered tube after shaping, reducing the difficulty of the shaping process, and reducing production losses and production costs.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a film-covered tube shaping device and shaping method, and a film-covered stent preparation method. Background Art

[0002] In recent years, stent grafts have become the mainstream product of artificial blood vessels, mainly used to treat diseases such as aortic dissection and aneurysm. Stent grafts mainly include metal stents and coatings. The coatings mainly play a role in blocking blood flow, and the metal stents are mainly used to support the coatings to maintain their shape. The coatings are mainly made of polytetrafluoroethylene and polyester. The coatings on traditional stent grafts are generally coated tubes formed by suturing a flat coating, which has the following defects: a large amount of water seepage at the sutures reduces the strength of the coated tubes; suturing is mainly done manually, with low production efficiency, and even suture failure leads to product scrapping. The currently developed coated tube is an integrated coated tube, which is directly woven into a coated tube through a weaving process, and no longer requires subsequent manual suturing into a tube. Obviously, this process has overcome the shortcomings of coated tubes formed by suturing a flat coating.

[0003] Since the one-piece coated tube is flat, it affects the subsequent suturing of the stent and other processes, so it is necessary to place the coated tube shaping device inside the one-piece coated tube to shape the one-piece coated tube. Conventional coated tubes are divided into straight coated tubes, tapered coated tubes and bifurcated coated tubes. Figure 1 As shown, Figure 1 It is a schematic diagram of a bifurcated coated tube. The bifurcated coated tube 10 includes: a main body section 11, a bifurcated section 12 and a branch section 13, one end of the bifurcated section 12 is connected to the main body section 11, and the other end of the bifurcated section 12 is connected to the branch section 13. However, in the process of shaping the bifurcated coated tube 10, since the structure changes when the main body section 11 transitions to two bifurcated sections 12, when the coated tube shaping device is placed from the main body section 11 into the bifurcated coated tube 10, the shape of the coated tube shaping device does not match the structure of the main body section 11 or the bifurcated section 12, causing the bifurcated coated tube 10 to tear, especially the weak points of the bifurcated coated tube 10 are easily torn. If the radial dimensions of the two bifurcated sections 12 are larger than the radial dimensions of the main body section 11, the coated tube shaping device cannot be installed therein, making the shaping process very difficult, thereby reducing the qualified rate of the coated products and causing large production losses.

[0004] Therefore, developing a film tube shaping device that can match the structure of the forked film tube, making the forked film tube not easy to tear, thereby reducing the difficulty of the shaping process and improving the qualified rate of the forked film tube has become an urgent problem to be solved by film processing manufacturers. Summary of the invention

[0005] The purpose of the present invention is to provide a film-covered tube shaping device and shaping method, and a film-covered stent preparation method, so as to solve the problems of difficulty in the shaping process of bifurcated film-covered tubes, easy tearing of bifurcated film-covered tubes, and low pass rate.

[0006] In order to solve the above technical problems, the present invention provides a film-coated tube shaping device, comprising: a main pipe section, at least two forked pipe sections and at least two branch pipe sections; the main pipe section is detachably connected to the proximal ends of at least two of the forked pipe sections; the distal end of each of the forked pipe sections is detachably connected to the proximal end of one of the branch pipe sections.

[0007] Optionally, the coated tube shaping device includes two forked pipe segments and two branch pipe segments, the radial dimension of the distal end of the forked pipe segment is the same as the radial dimension of the proximal end of the branch pipe segment, and the sum of the radial dimensions of the distal ends of the two forked pipe segments is greater than the radial dimension of the distal end of the main pipe segment.

[0008] Optionally, the two bifurcated pipe sections are symmetrically arranged along the central axis of the main pipe section.

[0009] Optionally, the bifurcated pipe segment includes a bifurcated end and a handle, the bifurcated end is used to adapt to the bifurcated segment of a bifurcated coated tube, the distal end of the bifurcated end is detachably connected to the proximal end of the branch pipe segment, the proximal end of the bifurcated end is connected to the distal end of the handle, the proximal end of the handle is detachably connected to the main pipe segment, and the main pipe segment is provided with a handle through hole matching the handle; the handle is arranged in the handle through hole.

[0010] Optionally, the coated tube shaping device includes two forked tube segments, each of which includes a forked end, the sum of the radial dimensions of the proximal ends of the two forked ends is equal to the radial dimension of the distal end of the main tube segment, and the radial dimension of the distal end of the forked end is greater than the radial dimension of the proximal end of the forked end.

[0011] Optionally, each of the forked ends has an axis, and the angle between the axes of the two forked ends is an acute angle.

[0012] Optionally, the handle is a cylindrical structure.

[0013] Optionally, the distal end of the handle protrudes out of the handle through hole, and the radial dimension of the handle through hole is larger than the radial dimension of the handle.

[0014] Optionally, the handle is a polygonal structure, and the handle is used to adjust the bifurcated end portion so that the axis of the bifurcated end portion coincides with the axis of the bifurcated segment of the bifurcated coated tube.

[0015] Optionally, the forked pipe segment also includes a positioning body, both ends of which are respectively connected to the forked end and the handle, the positioning body is arranged parallel to the axis of the handle, and the positioning body is used to adjust the forked end so that the axis of the forked end coincides with the axis of the forked segment of the forked coated tube.

[0016] Optionally, the positioning body is a polygonal rod.

[0017] Optionally, the positioning body is a cuboid.

[0018] Optionally, the sum of the lengths of the positioning body and the handle is greater than the length of the handle through hole.

[0019] Optionally, the positioning body is made of stainless steel or nylon.

[0020] Optionally, a radial dimension of the positioning body is smaller than a radial dimension of the main pipe section.

[0021] Optionally, the forked end, the handle and the positioning body are integrally formed.

[0022] Optionally, the film-coated tube shaping device further includes a first connecting portion and a second connecting portion, wherein the first connecting portion is disposed at the distal end of the bifurcated tube segment, and the second connecting portion is disposed at the proximal end of the branch tube segment; the first connecting portion is adapted to fit the second connecting portion.

[0023] Optionally, one of the first connection portion and the second connection portion includes a groove, and the other of the first connection portion and the second connection portion includes a protrusion, and the groove is matched with the protrusion.

[0024] Optionally, the film-coated tube shaping device adopts a thermal expansion coefficient greater than 60x 10 -6 Made of m / mk material.

[0025] In order to solve the above-mentioned technical problems, the present invention also provides a method for shaping a film-coated tube, which is used for shaping a bifurcated film-coated tube, wherein the bifurcated film-coated tube includes a connected main body section, at least two bifurcated sections and at least two branch sections, and is implemented by the film-coated tube shaping device as described above. The method for shaping the film-coated tube includes: inserting each of the branch tube sections from the distal end of the bifurcated film-coated tube into one of the branch sections; inserting each of the bifurcated tube sections from the proximal end of the bifurcated film-coated tube into one of the bifurcated sections; detachably connecting the distal end of each of the bifurcated tube sections to the proximal end of one of the branch tube sections; inserting the main tube section from the proximal end of the bifurcated film-coated tube into the main body section, and detachably connecting it to the proximal ends of the at least two bifurcated tube sections.

[0026] Optionally, the forked pipe segment includes a forked end, a positioning body and a handle, and both ends of the positioning body are respectively connected to the forked end and the handle; before the distal end of each branch pipe segment is detachably connected to the proximal end of one branch pipe segment, the orientation of the positioning bodies of at least two of the forked pipe segments is adjusted so that the forked end is adapted to the forked segment.

[0027] To solve the above technical problems, the present invention also provides a method for preparing a coated stent, comprising: shaping a bifurcated coated tube using the coated tube shaping device as described above; and suturing the shaped bifurcated coated tube and the stent to form the coated stent.

[0028] In a film-covered tube shaping device and shaping method, and a film-covered stent preparation method provided by the present invention, the film-covered tube shaping device includes a main tube section, at least two bifurcated tube sections, and at least two branch tube sections; the main tube section is detachably connected to the proximal ends of at least two of the bifurcated tube sections; the distal end of each of the bifurcated tube sections is detachably connected to the proximal end of one of the branch tube sections. With such a configuration, the film-covered tube shaping device includes three parts, namely, the main tube section, the bifurcated tube section, and the branch tube section. The three parts can be respectively inserted into the main body section, the bifurcated section, and the branch section of the bifurcated film-covered tube, and each part can be respectively adapted to each part of the bifurcated film-covered tube, thereby reducing the risk of the bifurcated film-covered tube being torn during the shaping process, improving the qualified rate of the bifurcated film-covered tube after shaping, reducing the difficulty of the shaping process, and reducing production losses and production costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0030] Figure 1 A schematic diagram of a bifurcated film-covered tube;

[0031] Figure 2 A schematic diagram of a film-coated tube shaping device according to an embodiment of the present invention;

[0032] Figure 3 A schematic diagram of a main pipe section according to an embodiment of the present invention;

[0033] Figure 4 for Figure 3 A left side view of the main pipe section is shown;

[0034] Figure 5 It is a front view of two bifurcated pipe sections according to an embodiment of the present invention;

[0035] Figure 6 for Figure 5 A top view of the bifurcated pipe segment is shown;

[0036] Figure 7 A schematic diagram of two branch pipe sections according to an embodiment of the present invention;

[0037] Figure 8 for Figure 7 A left side view of the branch pipe section is shown;

[0038] Fig. 9 It is a schematic diagram of a method for using a film-coated tube shaping device according to an embodiment of the present invention.

[0039] In the attached figure:

[0040] 10- bifurcated film-covered tube, 11- main body section, 12- bifurcated section, 13- branch section;

[0041] 100-main pipe section, 110-handle through hole;

[0042] 200 - bifurcated pipe section, 201 - first bifurcated pipe section, 202 - second bifurcated pipe section, 210 - bifurcated end, 220 - handle, 230 - positioning body, 231 - narrow side, 232 - wide side, 240 - first connecting portion;

[0043] 300 - branch pipe section, 301 - first bifurcated pipe section, 302 - second bifurcated pipe section, 310 - second connecting portion. DETAILED DESCRIPTION

[0044] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0045] As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise. In addition, in the following description, for ease of description, "distal end" and "proximal end" are used; "proximal end" and "distal end" represent opposite ends. In addition, in the following description, a large number of specific details are given in order to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some technical features known in the art are not described.

[0046] The embodiment of the present invention provides a film-covered tube shaping device and shaping method, and a method for preparing a film-covered stent, wherein the film-covered tube shaping device includes a main tube section, at least two bifurcated tube sections, and at least two branch tube sections; the main tube section is detachably connected to the proximal ends of at least two bifurcated tube sections; the distal end of each bifurcated tube section is detachably connected to the proximal end of one branch tube section. In this way, the film-covered tube shaping device includes three parts: the main tube section, the bifurcated tube section, and the branch tube section. The three parts can be respectively inserted into the main body section, the bifurcated section, and the branch section of the bifurcated film-covered tube, and each part can be respectively adapted to each part of the bifurcated film-covered tube, thereby reducing the risk of the bifurcated film-covered tube being torn during the shaping process, improving the qualified rate of the bifurcated film-covered tube after shaping, reducing the difficulty of the shaping process, and reducing production losses and production costs. Furthermore, the bifurcated tube section includes a bifurcated end and a handle, and the handle is used by the operator to insert the bifurcated end from the proximal end of the bifurcated film-covered tube into the bifurcated section. Furthermore, the bifurcated pipe segment also includes a positioning body, the two ends of which are respectively connected to the bifurcated end and the handle, and the positioning body is used to determine that the axis of the bifurcated end coincides with the axis of the bifurcated segment, thereby ensuring that the bifurcated end can adapt to the bifurcated segment.

[0047] The following description is given with reference to the accompanying drawings.

[0048] Figure 1 A schematic diagram of a bifurcated film-covered tube; Figure 2 A schematic diagram of a film-coated tube shaping device according to an embodiment of the present invention; Figure 3 A schematic diagram of a main pipe section according to an embodiment of the present invention; Figure 4 for Figure 3 A left side view of the main pipe section is shown; Figure 5 It is a front view of two bifurcated pipe sections according to an embodiment of the present invention; Figure 6 for Figure 5 A top view of the bifurcated pipe segment is shown; Figure 7 A schematic diagram of two branch pipe sections according to an embodiment of the present invention; Figure 8 for Figure 7 A left side view of the branch pipe section is shown; Fig. 9 It is a schematic diagram of a method for using a film-coated tube shaping device according to an embodiment of the present invention.

[0049] Please refer to Figures 1 to 8 In the process of shaping the coated tube, the coated tube shaping device is placed inside the bifurcated coated tube 10. The outer shape of the coated tube shaping device is directly attached to the bifurcated coated tube 10 and the bifurcated coated tube 10 is shaped and supported. The shaped bifurcated coated tube 10 is convenient for subsequent processes such as suturing the stent, thereby improving the product quality in the subsequent production process. Please refer to Figure 1The side close to the main section 11 of the bifurcated film-covered tube 10 is the proximal end of the bifurcated film-covered tube 10; the side close to the branch section 13 of the bifurcated film-covered tube 10 is the distal end of the bifurcated film-covered tube 10. The "proximal end" and "distal end" of the bifurcated film-covered tube 10 as above will be used to represent the two ends of each part of the film-covered tube shaping device adapted thereto.

[0050] like Figure 2 As shown, the film-coated tube shaping device includes: a main tube section 100 , at least two bifurcated tube sections 200 and at least two branch tube sections 300 .

[0051] like Figure 3 As shown, the main tube section 100 is used to match the main section 11 of the bifurcated coated tube 10. For example, if the main section 11 is cylindrical, the main tube section 100 is also cylindrical, and the diameter of the main tube section 100 is matched with the inner diameter of the main section 11, so that the main tube section 100 can shape and support the main section 11. In other embodiments, the shape of the main tube section 100 is adaptively adjusted according to the change of the shape of the main section 11, such as an elliptical shape.

[0052] like Figure 2 As shown, the bifurcated pipe segment 200 is adapted to the bifurcated segment 12. For example, the shape of the bifurcated segment 12 is an oblique cylinder or an oblique conical cylinder, or when the bifurcated segment 12 is connected to the main segment 11 and its structure becomes an oblique cylinder or an oblique conical cylinder, the shape of the portion of the bifurcated pipe segment 200 that is used to fit with the bifurcated coated tube 10 is also an oblique cylinder or an oblique conical cylinder; the bifurcated coated tube 10 includes two bifurcated segments 12, and the coated tube shaping device includes two bifurcated pipe segments 200; the angle between the axes of the two bifurcated segments 12 is an acute angle, and the angle between the axes of the two bifurcated pipe segments 200 is also adaptively an acute angle, so that the bifurcated pipe segment 200 can shape and support the bifurcated segment 12. In this embodiment, as Figure 2 As shown, preferably, the two bifurcated pipe segments 200 are respectively a first bifurcated pipe segment 201 and a second bifurcated pipe segment 202, and the two bifurcated pipe segments 200 are symmetrically arranged along the central axis of the main pipe segment 100. Of course, the two bifurcated pipe segments 200 may not be symmetrically arranged, for example, the shapes of the parts of the two bifurcated pipe segments 200 that contact the bifurcated segment 12 may be two different shapes or different sizes. In other embodiments, the number and shape of the bifurcated pipe segments 200 may be arranged according to the bifurcated segment 12, for example, if the number of the bifurcated segments 12 is three, the number of the bifurcated pipe segments 200 is also three, and the angles between the bifurcated pipe segments 200 may also be adapted according to the angles between the bifurcated segments 12.

[0053] like Figure 2 and Figure 7 As shown, the branch pipe segment 300 is matched with the branch segment 13, and the shape of the branch segment 13 is cylindrical, so the shape of the branch pipe segment 300 is also cylindrical, and the diameter of the branch pipe segment 300 is matched with the inner diameter of the branch segment 13, for example, the outer surface of the branch pipe segment 300 can fit with the branch segment 13, so that the branch pipe segment 300 can shape and support the branch segment 13. In other embodiments, the shape of the branch pipe segment 300 is adaptively adjusted according to the change of the shape of the branch segment 13, for example, it is an ellipse.

[0054] like Figure 2 As shown, the main pipe section 100 is detachably connected to the proximal ends of the at least two bifurcated pipe sections 200. The distal end of each bifurcated pipe section 200 is detachably connected to the proximal end of one of the branch pipe sections 300, for example, the film-coated tube shaping device preferably includes two bifurcated pipe sections 200, then the film-coated tube shaping device also includes a corresponding number of branch pipe sections 300, that is, two branch pipe sections 300. Preferably, the two branch pipe sections 300 include a first branch pipe section 301 and a second branch pipe section 302, the first branch pipe section 301 is connected to the first bifurcated pipe section 201, and the second branch pipe section 302 is connected to the second bifurcated pipe section 202. It can be understood that the end of the bifurcated pipe section 200 facing the proximal end of the bifurcated film-coated tube 10 is connected to the main pipe section 100, and the end facing the distal end of the bifurcated film-coated tube 10 is connected to the branch pipe section 300. In other embodiments, if there are several forked pipe segments 200, the number of branch pipe segments 300 is the same, and they are connected to the forked pipe segments 200 accordingly, so that the distal end of each forked pipe segment 300 can be connected to a branch pipe segment 300. In this way, the film-coated tube shaping device includes three parts, namely, the main pipe segment 100, the forked pipe segment 200 and the branch pipe segment 300. The three parts are detachably connected, so that the three parts can be respectively placed in the forked film-coated tube 10 and assembled together, so that the film-coated tube shaping device has the following advantages:

[0055] 1) It avoids the situation that when the traditional one-piece film-coated tube shaping device is inserted as a whole from the proximal end of the forked film-coated tube 10, the structure of the one-piece film-coated tube shaping device and the forked film-coated tube 10 do not match due to the change in the structure from the main section 11 to the forked section 12. When the film-coated tube shaping device provided in this embodiment is inserted into the forked film-coated tube 10, the three parts can be respectively inserted into the branch section 13, the forked section 12 and the main section 11 of the forked film-coated tube 10, so that it is not limited by the overall size of the forked film-coated tube 10, and the forked film-coated tube 10 can be effectively shaped. The size of each part can match each other, reducing the risk of the forked film-coated tube 10 being torn and reducing the difficulty of the shaping process, thereby improving the qualified rate of the forked film-coated tube 10, reducing production losses and production costs.

[0056] 2) Since there is a slight hole left by the weaving process at the bottom center point of the forked segment 12, the one-piece coated tube shaping device needs to overcome excessive friction when it is placed in the forked coated tube 10, resulting in the tearing of the forked segment 12. The coated tube shaping device provided in this embodiment has three independent parts, namely the main tube segment 100, the forked tube segment 200 and the branch tube segment 300, and the forces they are subjected to are also independent of each other; the forces applied by the three parts to the main segment 11, the forked segment 12 and the branch segment 13 are also independent of each other; when the operator applies force to the main tube segment 100 and the branch tube segment 300, the force is not easy to act directly on the forked tube segment 300, and thus is not easy to affect the bottom center point of the forked segment 12, thereby reducing the risk of the forked segment 12 being torn.

[0057] 3) The film-coated tube shaping device provided in this embodiment places the three parts into the bifurcated film-coated tube 10 respectively for assembly, and its design is simple and easy to use.

[0058] Further, such as Figure 1 As shown, when the bifurcated segment 12 of the bifurcated coated tube 10 is of variable diameter, or the sum of the radial dimensions of the two or more branch segments 13 is greater than the radial dimension of the main segment 11, for example, the number of branch segments 13 is two, and the sum of the radial dimensions of the two branch segments 13 is greater than the diameter of the main segment 11, the conventional one-piece coated tube shaping device cannot be inserted into the bifurcated coated tube 10 during the process of being inserted from the proximal end of the bifurcated coated tube 10 and installed in the bifurcated coated tube 10. Therefore, preferably, as Figure 2As shown, the film-coated tube shaping device of this embodiment includes: two bifurcated tube segments 200 and two branch tube segments 300. The branch tube segment 300 is, for example, a cylinder, and the radial dimension of the distal end of the bifurcated tube segment 200 is the same as the radial dimension of the proximal end of the branch tube segment 300. The sum of the radial dimensions of the distal ends of the two bifurcated tube segments 200 is greater than the radial dimension of the distal end of the main tube segment 100. When the film-coated tube shaping device is installed, the branch tube segment 300, the bifurcated tube segment 200 and the main tube segment 100 are installed respectively. When the bifurcated tube segment 200 is installed to the main section 11 and transitions to the bifurcated section 12, the friction between the branch tube segment 300, the bifurcated tube segment 200 and the bifurcated film-coated tube 10 is improved to prevent the bifurcated film-coated tube 10 from tearing. Preferably, each branch tube segment 300 is connected to the distal end of the bifurcated tube segment 200 and is arranged parallel to the axis of the main tube segment 100. The size and shape of the two branch pipe segments 300 can be exactly the same, for example, the two branch pipe segments 300 are both cylindrical with the same diameter. In other embodiments, the size and shape of the two branch pipe segments 300 may not be exactly the same, for example, one branch pipe segment has a larger diameter and the other branch pipe segment has a smaller diameter. It should be noted that the length of the branch pipe segment 300 needs to be 10 to 40 mm longer than the length of the branch segment 13, specifically about 20 mm, so that a certain safety length is reserved when the branch pipe segment 300 is matched with the branch segment 13, ensuring that all branch segments 13 can be shaped and supported by the branch pipe segment 300; the length of the bifurcated pipe segment 200 can be completely consistent with the length of the bifurcated segment 12, and the axis of the bifurcated pipe segment 200 can coincide with the axis of the bifurcated pipe 12.

[0059] As a preference, Figures 5 and 6 The bifurcated tube segment 200 includes a bifurcated end portion 210 and a handle 220. The bifurcated end portion 210 is used to match the bifurcated segment 12 of a bifurcated coated tube 10. Specifically, the bifurcated end portion 210 is in direct contact with the bifurcated segment 12 to achieve a shaping effect. Figure 2 As shown, the distal end of the forked end portion 210 is detachably connected to the proximal end of the branch pipe segment 300, the proximal end of the forked end portion 210 is connected to the distal end of the handle 220, and the proximal end of the handle 220 is detachably connected to the main pipe segment 100. Since the forked segment 12 is relatively short, usually less than 15 mm, and the main body segment 11 is relatively long, with a length greater than 140 mm, when placing the forked end portion 210 into the forked segment 12, a handle 220 is required for the operator to place the forked end portion 210 from the proximal end of the forked coated tube 10 into the forked segment 12 when installing the forked pipe segment 200. After installing the forked pipe segment 200, the main pipe segment 100 needs to be installed into the main body segment 11. In order to avoid the obstruction of the handle 220, as shown in FIG. Figure 3 to Figure 4The main pipe section 100 is provided with a handle through hole 110 that matches the handle 220, and the handle 220 is arranged in the handle through hole 110. The structure of the handle through hole 110 matches the structure of the handle 220. For example, further, in order to facilitate the processing of the handle 220 and the hand feeling of the operator holding it, the handle 220 is a cylindrical structure, the handle through hole 110 is a cylindrical through hole, and the diameter of the handle through hole 110 is not less than the diameter of the handle 200. Further, since the bifurcated pipe section 200 is symmetrically arranged, the handle 220 of the bifurcated pipe section 200 is also symmetrically arranged and the handle 220 has the same size, then the handle through hole 110 of the main pipe section 100 is also symmetrically arranged and has the same size. It should be noted that the length of the main pipe section 100 needs to be about 20 mm longer than the length of the main body section 11, so that a certain safety length is reserved when the main pipe section 100 matches the main body section 11, ensuring that all the main body sections 11 can be shaped and supported by the main pipe section 100.

[0060] Further, such as Figure 5 and Figure 6 As shown, the film-coated tube shaping device includes two bifurcated tube sections 200, and each bifurcated tube section 200 includes a bifurcated end 210. The sum of the radial dimensions of the proximal ends of the two bifurcated ends 210 is equal to the radial dimension of the distal end of the main tube section 100. For example, the diameters of the proximal ends of the two bifurcated ends 210 are equal, thereby ensuring that the connection parts between the bifurcated ends 200 and the main tube section 100 have the same dimensions. The radial dimension of the distal end of the bifurcated end 210 is greater than the radial dimension of the proximal end of the bifurcated end 210. For example, the bifurcated end 210 is an oblique conical cylinder, and the diameter of the distal end of the bifurcated end 210 is greater than the diameter of the proximal end of the bifurcated end 210, thereby making the radial dimensions of the distal ends of the two bifurcated ends 200 greater than the dimensions of the distal end of the main tube section 100.

[0061] Further, each of the forked ends 210 has an axis, and the angle between the axes of the two forked ends 210 is an acute angle, for example, 10 to 45°, preferably 15°. Among them, the angle between the axes of the two forked ends 210 can be set according to actual conditions, and this embodiment does not limit it. In other embodiments, the diameter of the distal end of the forked end 210 can be equal to the diameter of the proximal end of the forked end 210, and the diameter of the distal end of each forked end 210 is the same as the diameter of the corresponding branch pipe section 300. When there is a certain angle between the axes of the two forked ends 210, the maximum radial dimension of the distal ends of the two forked ends 210 (i.e., the sum of the distance between the distal ends of the two forked ends 210 and the diameter of the two forked ends 210) is greater than the maximum radial dimension of the proximal ends of the two forked ends 210 (i.e., the sum of the distance between the proximal ends of the two forked ends 210 and the diameter of the two forked ends 210). In this way, the film tube shaping device can match the film whose size gradually increases at the position of the forked segment 12, so that when the film tube shaping device is installed, the branch pipe segment 300 of the film tube shaping device is inserted from the branch segment 13, thereby avoiding friction between the branch pipe segment 300 and the forked film tube 10 when the branch pipe segment 300 is installed from the main segment 11, thereby avoiding damage to the forked film tube 10.

[0062] Usually, if Figure 2 As shown, after the main pipe section 100 is installed, the operator will also adjust the angle of the forked end 210 to match the angle of the forked section 12. Therefore, a certain length of the handle 220 can be reserved outside the main pipe section 100 to facilitate the operator to adjust the angle of the handle 220. Preferably, the distal end of the handle 220 protrudes outside the handle through hole 110. For example, after the forked pipe section 200 and the main pipe section 100 are installed, the axial length of the handle 220 is 40 to 50 mm longer than the axial length of the handle through hole 210. At the same time, the radial dimension of the handle through hole 110 is larger than the radial dimension of the handle 200, which facilitates the rotation of the handle 200.

[0063] like Figure 5As shown, when the forked end portion 210 is installed, the forked end portion 210 has an angle limitation. For example, if the axis of the forked end portion 210 deviates from the axis of the forked segment 12, it will affect the shaping of the forked coated tube 10. Therefore, during installation, it is necessary to adjust the angle of the forked end portion 210. In a preferred embodiment, the structure of the handle 220 can also be a polygon. The handle 220 is fixedly connected to the forked end portion 210. The handle 220 is used to adjust the forked end portion 210 so that the axis of the forked end portion 210 coincides with the axis of the forked segment 12 of the forked coated tube 10. For example, the handle 220 is a rectangular parallelepiped. When one face of the rectangular parallelepiped faces a predetermined direction (for example Figure 5 In the figure, the direction perpendicular to the outside of the figure is the predetermined direction), it can be said that the axis of the forked end 210 coincides with the axis of the forked section 12. Of course, the polygon can also be a cube, a triangular prism or a hexahedron. It should be noted that when installing the forked end 210, since the forked coated tube 10 is transparent, the operator can visually judge whether the forked section 12, the forked end 210 or the rectangular handle is skewed.

[0064] For further information, please continue to refer to Figure 5 Preferably, the bifurcated tube segment 200 further includes a positioning body 230, and the two ends of the positioning body 230 are respectively connected to the bifurcated end 210 and the handle 220. Preferably, the connection method is a fixed connection. The positioning body 230 is arranged parallel to the axis of the handle 220, and the positioning body 230 is used to adjust the bifurcated end 210 so that the axis of the bifurcated end 210 coincides with the axis of the bifurcated segment 12 of the bifurcated coated tube 10. It can be understood that when installing the bifurcated pipe segment 200, the operator holds the handle 220, inserts the bifurcated end 210 from the proximal end of the bifurcated coated tube 10, and places it into the bifurcated segment 12. When determining whether the bifurcated end 210 is consistent with the position of the bifurcated segment 12, the operator can observe the position of the positioning body 230 from the outside of the bifurcated coated tube 10, judge the relative position of the bifurcated segment 12 and the bifurcated end 210, and adjust the orientation of the positioning body 230 to ensure that the angle of the bifurcated end 210 is consistent with the angle of the bifurcated segment 12.

[0065] As a preference, Figures 5 and 6As shown, the cross section of the positioning body 230 along the axial direction of the main pipe section is a polygonal rod. In this embodiment, the positioning body 230 is preferably a cuboid, one end of the cuboid is connected to the forked end 210, and the other end is connected to the handle 220. The cross section of the cuboid is, for example, a rectangle, so that the cuboid has two mutually parallel narrow sides 231 and two mutually parallel wide sides 232. In specific implementation, the operator observes whether a certain face of the rectangular positioning body is facing the preset direction, for example, the operator observes whether the narrow side 231 of the rectangle is facing the operator, so that the operator can only see one narrow side 231, but not the other three faces. If not, adjust the direction of the handle 220 to ensure that one face of the positioning body 230 faces the predetermined direction, that is, ensure that the operator can only see one narrow edge 231, and the other three faces are invisible, which indicates that the orientation of the bifurcated end 210 is correct. The positioning body 230 plays a positioning role in the process of placing the bifurcated end 210 into the bifurcated film 12, so that the angle of the bifurcated tube section 200 is more accurate. In actual use, the length of the positioning body 230 is greater than 50 mm.

[0066] Preferably, the positioning body 230 is a wave shaft rod or a broken line shaft rod. The operator determines whether the bifurcated pipe segment 200 is at a predetermined angle by pointing the surface where the axis of the wave shaft rod or the broken line shaft rod is facing a predetermined direction. In this way, the positioning body 230 is provided for positioning, and the handle 220 can be set to a cylindrical shape to prevent the edge of the polygon from strangling the operator's hand when the operator holds the handle 220 of the polygon. Preferably, the sum of the lengths of the positioning body 230 and the handle 220 is greater than the length of the handle through hole 220, for example, the length of the positioning body 230 and the handle 220 is 40 to 50 mm longer than the length of the handle through hole 220, which has the same meaning as the length of the handle 220 being greater than the handle through hole 310 as described above, and can facilitate the operator to adjust the angle of the bifurcated pipe segment 200.

[0067] Furthermore, the material of the positioning body 230 is stainless steel or nylon. Stainless steel has greater rigidity, greater support force, and higher bending and compressive strength. For example, when the rectangular positioning body is thinner (<12mm), the stainless steel material can resist the bending force when the size is thinner, thereby avoiding the positioning body 230 being too small and possibly causing bending or breaking. Preferably, when the radial dimension of the positioning body 230 is not less than 12mm, that is, when the size of the positioning body is thicker (≥12mm), due to the large radial dimension of the positioning body 230, the nylon material can resist the compression force. The positioning body is made of nylon, which facilitates the integral processing of the positioning body with the forked end and the handle, thereby saving processing costs.

[0068] Preferably, the radial dimension of the positioning body 230 is smaller than the radial dimension of the main pipe section 100 , so that the positioning body 230 can be disposed in the handle through hole 110 in the main pipe section 100 .

[0069] Furthermore, the film-coated tube shaping device adopts a thermal expansion coefficient greater than 60*10 -6 m / mk material. Specifically, the main pipe section 100, the branch pipe section 300, the forked end 210 of the forked pipe section 200, or the handle 220 of the forked pipe section 200 has a thermal expansion coefficient greater than 60 x 10 -6 m / mk, for example, the material is preferably nylon, so that when the coated tube shaping device is shaping the bifurcated coated tube 10, it can undergo thermal expansion according to the temperature increase. Compared with materials with lower thermal expansion coefficients, it can further support the bifurcated coated tube 10 to prevent the bifurcated coated tube 10 from remaining flat and unable to be formed. Compared with the traditional one-piece coated tube shaping device, the material used has a high thermal expansion coefficient, which avoids material breakage and deformation, thereby avoiding deformation of the bifurcated coated tube 10 and improving the yield of the bifurcated coated tube 10. More preferably, the material is nylon 66. Nylon 66 and stainless steel materials do not have any loss or damage during the shaping process of the bifurcated coated tube 10, and the coated tube shaping device can be reused to reduce the cost of shaping the bifurcated coated tube 10.

[0070] Further, such as Figures 5 to 8, the bifurcated pipe segment 200 is connected to the branch pipe segment 300 through a group of connecting parts. Specifically, the film-coated tube shaping device also includes a first connecting part 240 and a second connecting part 310. The first connecting part 240 is arranged at the distal end of the bifurcated pipe segment 200, and the second connecting part 310 is arranged at the proximal end of the branch pipe segment 300; the first connecting part 240 and the second connecting part 310 are adapted. Preferably, one of the first connecting part 240 and the second connecting part 310 includes a groove, and the other of the first connecting part 240 and the second connecting part 310 includes a protrusion, and the groove is adapted to the protrusion. For example, preferably, the first connecting part 240 includes a groove, and the second connecting part 310 includes a protrusion, and the groove is adapted to the protrusion. More specifically, the protrusion is a cylindrical protrusion structure, and the groove is a cylindrical concave groove. The cylindrical diameter and height of the cylindrical protrusion structure are consistent with the size of the cylindrical concave groove, so that the connection parts of the bifurcated pipe section 200 and the branch pipe section 300 can be matched and combined with each other. In other embodiments, those skilled in the art can adaptively adjust the structure of the protrusion and the groove according to actual conditions. The protrusion and the groove can also be a square structure, a rectangular structure, an elliptical structure or a polygonal structure, etc. The number of the groove and the protrusion is not limited, and can be one or more. The first connecting part 240 and the second connecting part 310 can also be a magnet assembly, one of the magnet assemblies is arranged in the first connecting part 240, and the other of the magnet assembly is arranged in the second connecting part 310. The first connecting part 240 and the second connecting part 310 can also be a combination of a groove protrusion structure and a magnet assembly. For example, one end of the groove is provided with a magnetic piece in a magnet assembly, and one end of the protrusion is provided with another magnetic piece in a magnet assembly, so that the connection part is connected more tightly.

[0071] This embodiment also provides a film-coated tube shaping method for shaping a bifurcated film-coated tube 10, wherein the bifurcated film-coated tube 10 includes a connected main body section 11, at least two bifurcated sections 12, and at least two branch sections 13. Figures 1 to 9 As shown, the shaping method of the film-coated tube is implemented by using the film-coated tube shaping device as described above, and the shaping method of the film-coated tube includes:

[0072] S1: Each branch pipe segment 300 is respectively placed into one of the branch segments 13 from the distal end of the bifurcated coated tube 10. Specifically, the branch pipe segment 300 preferably includes a first branch pipe segment 301 and a second branch pipe segment 302. The first branch pipe segment 301 and the second branch pipe segment 302 are preferably placed from the distal ends of different branch segments 13 of the bifurcated coated tube 10. The branch pipe segment 300 preferably includes a second connecting portion 310, and the second connecting portion 310 is directed toward the proximal end of the bifurcated coated tube 10.

[0073] S2: Each of the bifurcated tube segments 200 is respectively placed into one of the bifurcated segments 12 from the proximal end of the bifurcated coated tube 10. In this embodiment, the bifurcated tube segment 200 preferably includes a first bifurcated tube segment 201 and a second bifurcated tube segment 202. Preferably, the first bifurcated tube segment 201 and the second bifurcated tube segment 202 are respectively placed into different bifurcated segments 12 from the proximal end of the bifurcated coated tube 10, so that the first bifurcated tube segment 201 can be connected to the first branch tube segment 301, and the second bifurcated tube segment 202 can be connected to the second branch tube segment 301.

[0074] In this embodiment, the bifurcated pipe segment 200 preferably includes a bifurcated end 210, a handle 220, and a positioning body 230, and both ends of the positioning body 230 are respectively connected to the bifurcated end 210 and the handle 220. Preferably, before the step of "the distal end of each bifurcated pipe segment 200 is detachably connected to the proximal end of one branch pipe segment 300 in S3", the orientations of the positioning bodies 230 of at least two bifurcated pipe segments 200 are adjusted so that the bifurcated end 210 is matched with the bifurcated segment 12. Specifically, when installing the bifurcated pipe segment 200, the operator first holds the handle 220 of the first bifurcated pipe segment 201, and puts the bifurcated end portion 210 into the position of the bifurcated segment 12 (wherein the position of the bifurcated segment 12 indicates that the bifurcated pipe segment 201 and the bifurcated segment 12 are close to overlapping and not completely overlapping), and keeps the position and direction of the first bifurcated pipe segment 201 unchanged; then holds the handle 220 of the second bifurcated pipe segment 202, and similarly puts the bifurcated end portion 210 into the position of another bifurcated segment 12 (wherein the position of the bifurcated segment 12 indicates that the bifurcated pipe segment 201 and the bifurcated segment 12 are close to overlapping and not completely overlapping); then observes the direction of the positioning body 230 to determine whether the two bifurcated pipe segments 201 and the bifurcated segment 12 are close to overlapping and not completely overlapping. The position and angle of the forked end 210 are checked to see whether they can completely overlap with the forked segment 12, including whether they are skewed or flush, symmetrical, etc., and the positioning body 230 is adjusted to face a predetermined direction so that the forked end 210 is compatible with the forked segment 12. The specific adjustment method can refer to the adjustment method of the positioning cuboid 230 as described above, which will not be repeated here; finally, the first forked pipe segment 201 and the second forked pipe segment 202 are pushed into the forked segment 12 at the same time, and the first connecting part 240 of the forked pipe segment 201 is connected and fit with the second connecting part 310 of the branch pipe segment 300, so that the junction between the forked pipe segment 201 and the branch pipe segment 300 is smooth and seamless. In other embodiments, the bifurcated pipe segment 200 includes a bifurcated end 210 and a handle 220, and the handle 220 is used to locate the position of the bifurcated end 210. The operator needs to adjust the orientation of the handles 220 of at least two of the bifurcated pipe segments 200 so that the bifurcated end 210 of the bifurcated pipe segment 200 connected to the handle 220 is compatible with the bifurcated segment 12 of the bifurcated coated tube 10.

[0075] S3: Removably connect the distal end of each bifurcated pipe segment 200 to the proximal end of one branch pipe segment 300. Specifically, the branch pipe segment 300 preferably includes a second connecting portion 310. The operator removably connects the first connecting portion 240 and the second connecting portion 310 of the bifurcated pipe segment 200.

[0076] S4: insert the main tube section 100 from the proximal end of the bifurcated film-covered tube 10 into the main body section 11, and detachably connect it with the proximal ends of the at least two bifurcated tube sections 200. After the bifurcated tube section 200 is installed, the handle 220 stays at the position of the main body section 11, which affects the installation of the main tube section 100. Therefore, the main tube section 100 is preferably provided with a handle through hole 110. After the branch tube section 300 and the bifurcated tube section 200 are installed, the main tube section 100 is passed through the handle 220 to complete the installation of the main tube section 100.

[0077] Afterwards, the operator can preferably clamp and fix the branch pipe section 300, the bifurcated pipe section 200 and the main pipe section 100. Specifically, the operator can first stand up the film-coated tube shaping device, that is, the main pipe section 100 faces the bottom surface or the tabletop, and the branch pipe section 300 faces the opposite direction, so that the operator can apply force conveniently; then apply a thrust to the branch pipe section 300 toward the bifurcated pipe section 200 to ensure that the connection between the branch pipe section 300 and the bifurcated pipe section 200 is seamless and tight; then hold the handle 220 extending out of the main pipe section 100 with one hand, and apply a thrust to the proximal end of the main pipe section 100 with the other hand, so that there is a certain squeezing force between the main pipe section 100 and the bifurcated pipe section 200, so as to ensure that the connection between the main pipe section 100 and the bifurcated pipe section 200 is seamless and tight. At this time, the film-coated tube shaping device can open the inside of the bifurcated film-coated tube 10, and the film-coated tube shaping device is installed. It should be understood that the operator can complete the tightening by manual operation, or can use auxiliary tightening tools such as pliers to tighten.

[0078] This embodiment also provides a method for preparing a stent graft, comprising: shaping a bifurcated coated tube 10 using the coated tube shaping device as described above; and suturing the shaped bifurcated coated tube 10 and the stent to form a coated stent graft. The method for preparing the stent graft has the beneficial effects brought by the coated tube shaping device, which will not be described in detail here. The suturing technical scheme and principle adopted by the method for preparing the stent graft can refer to the prior art and will not be described in detail here.

[0079] In a film-covered tube shaping device and shaping method, and a film-covered stent preparation method provided by the present invention, the film-covered tube shaping device includes a main tube section, at least two bifurcated tube sections, and at least two branch tube sections; the main tube section is detachably connected to the proximal ends of at least two bifurcated tube sections; the distal end of each bifurcated tube section is detachably connected to the proximal end of one branch tube section. With such a configuration, the film-covered tube shaping device includes three parts, namely, the main tube section, the bifurcated tube section, and the branch tube section. The three parts can be respectively inserted into the main body section, the bifurcated section, and the branch section of the bifurcated film-covered tube, and each part can be respectively adapted to each part of the bifurcated film-covered tube, thereby reducing the risk of the bifurcated film-covered tube being torn during the shaping process, improving the qualified rate of the bifurcated film-covered tube after shaping, reducing the difficulty of the shaping process, and reducing production losses and production costs.

[0080] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A film-coated tube shaping device, characterized in that: include: A main pipe section, at least two bifurcated pipe sections and at least two branch pipe sections; The main pipe section is detachably connected to the proximal ends of at least two of the bifurcated pipe sections; The distal end of each bifurcated pipe segment is detachably connected to the proximal end of one branch pipe segment; The film-coated tube shaping device adopts a thermal expansion coefficient greater than 60x10 -6 Made of m / mk material.

2. The film-coated tube shaping device according to claim 1, characterized in that: The coated tube shaping device includes two bifurcated tube segments and two branch tube segments, the radial dimension of the distal end of the bifurcated tube segment is the same as the radial dimension of the proximal end of the branch tube segment, and the sum of the radial dimensions of the distal ends of the two bifurcated tube segments is greater than the radial dimension of the distal end of the main tube segment.

3. The film-coated tube shaping device according to claim 2, characterized in that: The two bifurcated pipe sections are symmetrically arranged along the central axis of the main pipe section.

4. The film-coated tube shaping device according to claim 1, characterized in that: The bifurcated pipe segment includes a bifurcated end and a handle, the bifurcated end is used to adapt to the bifurcated segment of a bifurcated coated tube, the distal end of the bifurcated end is detachably connected to the proximal end of the branch pipe segment, the proximal end of the bifurcated end is connected to the distal end of the handle, the proximal end of the handle is detachably connected to the main pipe segment, the main pipe segment is provided with a handle through hole matching the handle; the handle is arranged in the handle through hole.

5. The film-coated tube shaping device according to claim 4, characterized in that: The film-coated tube shaping device includes two forked tube segments, each of which includes a forked end portion, the sum of the radial dimensions of the proximal ends of the two forked ends is equal to the radial dimension of the distal end of the main tube segment, and the radial dimension of the distal end of the forked end portion is greater than the radial dimension of the proximal end of the forked end portion.

6. The film-coated tube shaping device according to claim 5, characterized in that: Each of the forked ends has an axis, and the angle between the axes of the two forked ends is an acute angle.

7. The film-coated tube shaping device according to claim 4, characterized in that: The handle is a cylindrical structure.

8. The film-coated tube shaping device according to claim 4, characterized in that: The distal end of the handle protrudes out of the handle through hole, and the radial dimension of the handle through hole is larger than the radial dimension of the handle.

9. The film-coated tube shaping device according to claim 4, characterized in that: The handle is a polygonal structure, and the handle is used to adjust the bifurcated end portion so that the axis of the bifurcated end portion coincides with the axis of the bifurcated segment of the bifurcated coated tube.

10. The film-coated tube shaping device according to claim 4, characterized in that: The bifurcated pipe segment also includes a positioning body, the two ends of which are respectively connected to the bifurcated end and the handle, the positioning body is arranged parallel to the axis of the handle, and the positioning body is used to adjust the bifurcated end so that the axis of the bifurcated end coincides with the axis of the bifurcated segment of the bifurcated coated tube.

11. The film-coated tube shaping device according to claim 10, characterized in that: The positioning body is a polygonal rod.

12. The film-coated tube shaping device according to claim 10, characterized in that: The positioning body is a cuboid.

13. The film-coated tube shaping device according to claim 10, characterized in that: The sum of the lengths of the positioning body and the handle is greater than the length of the handle through hole.

14. The film-coated tube shaping device according to claim 10, characterized in that: The material of the positioning body is stainless steel or nylon.

15. The film-coated tube shaping device according to claim 10, characterized in that: The radial dimension of the positioning body is smaller than the radial dimension of the main pipe section.

16. The film-coated tube shaping device according to claim 10, characterized in that: The forked end, the handle and the positioning body are integrally formed.

17. The film-coated tube shaping device according to claim 1, characterized in that: The film-coated tube shaping device also includes a first connecting part and a second connecting part, wherein the first connecting part is arranged at the distal end of the bifurcated tube segment, and the second connecting part is arranged at the proximal end of the branched tube segment; the first connecting part is adapted to the second connecting part.

18. The film-coated tube shaping device according to claim 17, characterized in that: One of the first connection portion and the second connection portion includes a groove, and the other of the first connection portion and the second connection portion includes a protrusion, and the groove is matched with the protrusion.

19. A method for shaping a film-coated tube, used for shaping a bifurcated film-coated tube, wherein the bifurcated film-coated tube comprises a connected main body section, at least two bifurcated sections and at least two branch sections, characterized in that: The film-coated tube shaping device according to any one of claims 1 to 18 is used, and the film-coated tube shaping method comprises: Inserting each branch tube segment into one of the branch segments from the distal end of the bifurcated coated tube; Place each of the bifurcated tube segments into one of the bifurcated segments from the proximal end of the bifurcated coated tube; Removably connecting the distal end of each bifurcated pipe segment to the proximal end of one branch pipe segment; The main tube segment is placed into the main body segment from the proximal end of the bifurcated film-covered tube, and is detachably connected to the proximal ends of the at least two bifurcated tube segments.

20. The method for shaping a film-coated tube according to claim 19, characterized in that: The forked pipe segment includes a forked end, a positioning body and a handle, and the two ends of the positioning body are respectively connected to the forked end and the handle; before the distal end of each branch pipe segment is detachably connected to the proximal end of a branch pipe segment, the orientation of the positioning bodies of at least two of the forked pipe segments is adjusted so that the forked end is adapted to the forked segment.

21. A method for preparing a stent graft, characterized in that: include: The bifurcated film-coated tube is shaped using the film-coated tube shaping device described in any one of claims 1 to 18; The shaped bifurcated coated tube and the stent are sutured to form a coated stent.

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