A covered stent

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a covered stent, which comprises a stent body and a covering arranged on the stent body, wherein the stent body comprises a keel, a wave ring assembly and a sleeve joint assembly for connecting the keel and the wave ring assembly; the wave ring assembly comprises at least one curved section connected to the keel, and the curved section comprises a plurality of curved wave rings arranged on the keel in sequence; the sleeve joint assembly comprises a plurality of curved sleeves for connecting adjacent curved wave rings; and the wave ring assembly further comprises a windowing section for puncturing the covering. According to the covered stent, puncturing can be performed on the windowing section to adapt to the branch vessels on the aortic arch, and according to the shape of the vessels, the covered stent can be arranged in a preset curved shape through the curved sleeves, so as to reduce the pressure of the covered stent on the inner wall of the vessels, reduce the stimulation of the covered stent on the vessels and prevent new vessel breaks.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a covered stent. BACKGROUND

[0002] Aortic aneurysm and aortic dissection are diseases that seriously endanger human life safety at present. If not actively treated, the aortic aneurysm and dissection will continue to enlarge, and finally rupture, causing serious complications and death. With the increasing number of patients with hypertension, hyperlipidemia and diabetes, the incidence of aortic aneurysm and aortic dissection is also significantly increasing.

[0003] Traditional open surgery for aortic aneurysm and aortic dissection has the characteristics of large trauma, high mortality, long operation time, high incidence of postoperative complications and high surgical difficulty, while endovascular treatment has the characteristics of small trauma, fewer postoperative complications, short operation time and low surgical difficulty, and gradually becomes the main way for treating aortic aneurysm and aortic dissection at present. By implanting a covered stent in the aorta, the vascular lesions are isolated outside the covered stent, and the blood flow is constrained to flow through the inside of the covered stent, thereby achieving the purpose of protecting the blood vessels.

[0004] At present, the overall structure of the aortic stent product is mostly a straight cylinder structure with a keel. However, the shape of the aorta is not a regular straight cylinder, especially the aortic arch is curved. Therefore, the covered stent implanted in the curved segment part of the aortic arch and the vicinity of the aortic arch will produce elastic straightening force and stress formed thereby after being passively bent, which is easy to cause new aortic rupture. The occurrence of new aortic rupture is the primary risk factor for aortic dissection after endovascular repair.

[0005] Therefore, there is a need for a new technical solution to solve the above problems. SUMMARY

[0006] The purpose of the present application is to at least solve the problem that the straightening force of the covered stent and the stress formed thereby easily cause new aortic rupture.

[0007] One aspect of the present application provides a covered stent, comprising a stent body and a covering film arranged on the stent body, wherein the stent body comprises a keel, a wave coil assembly and a sleeve joint assembly for connecting the keel and the wave coil assembly; the wave coil assembly comprises at least one curved segment connected to the keel, and the curved segment comprises a plurality of curved wave coils arranged on the keel in sequence; the sleeve joint assembly comprises a plurality of curved sleeves for connecting adjacent curved wave coils; and the wave coil assembly further comprises a windowed segment for puncturing the covering film.

[0008] According to the covered stent in the application, the covered stent can be adapted to the branch vessels on the aortic arch by puncturing the windowed section, and the covered stent can be set to a preset curved shape by the curved bending sleeve according to the shape of the vessels, so as to reduce the pressure of the covered stent on the inner wall of the vessels, reduce the stimulation of the covered stent on the vessels, and prevent new vessel rupture.

[0009] In addition, the covered stent according to the application can further have the following additional technical features:

[0010] In some embodiments of the application, the windowed section comprises a plurality of spaced-apart windowed turns, and the adjacent windowed turns are connected by the covering film.

[0011] In some embodiments of the application, the windowed section comprises a windowed area for puncturing and a non-windowed area, the windowed area is arranged on the side close to the keel, the non-windowed area is arranged on the side away from the keel, and the covering film in the non-windowed area is provided with a reinforcing wire.

[0012] In some embodiments of the application, the curved turn comprises a high turn and a low turn connected in a head-to-tail manner, the high turn is arranged on the side close to the keel, the low turn is arranged on the side away from the keel, and the axial height of the high turn is greater than the axial height of the low turn.

[0013] In some embodiments of the application, the axial height of the windowed turn is less than or equal to the axial height of the low turn.

[0014] In some embodiments of the application, the bending directions and / or bending amplitudes of the plurality of bending sleeves are the same or different.

[0015] In some embodiments of the application, the turn assembly further comprises a connecting section at the proximal end of the stent body, the connecting section comprises a connecting turn and a supporting turn, the distal end of the connecting turn is connected to the proximal end of the covering film, the proximal end of the connecting turn is used to connect a delivery device release device, and the supporting turn is used to support the proximal edge of the covering film.

[0016] In some embodiments of the application, the adjacent curved turns are connected by connecting rods, the curved turns are fixedly connected to the connecting rods by the bending sleeves, and a plurality of connecting rods are sequentially connected to form part of the keel; the curved turns and the connecting rods are integrally woven by weaving wires, and the adjacent curved turns are connected in a head-to-tail manner by the connecting rods.

[0017] In some embodiments of the present application, the sleeve assembly further comprises a pressing tooth groove recessed towards the inside of the bending sleeve, the pressing tooth groove being used to fix the connection between the bending section and the keel, the bending sleeve comprising a first pressing surface and a second pressing surface arranged oppositely, and the pressing tooth groove being arranged on the first pressing surface and / or the second pressing surface.

[0018] In some embodiments of the present application, the number and / or shape of the pressing tooth groove arranged on the first pressing surface of the bending sleeve is different from that of the pressing tooth groove arranged on the second pressing surface.

[0019] In some embodiments of the present application, the pressing tooth groove comprises a first pressing groove arranged on the first pressing surface and a second pressing groove arranged on the second pressing surface; the number of the first pressing groove is less than that of the second pressing groove, and the first pressing groove is arranged staggeredly with the second pressing groove.

[0020] In some embodiments of the present application, the bending sleeve is bent towards the inside of the stent body; the first pressing surface is arranged towards the inside of the stent body, and the second pressing surface is arranged towards the outside of the stent body. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 FIG. 1 is a schematic diagram of the overall structure of the covered stent in Embodiment One of the present application;

[0022] Figure 2 FIG. 2 is a schematic diagram of the overall structure of the stent body in Embodiment One of the present application;

[0023] Figure 3 FIG. 3 is a schematic diagram of the structure of the bending section in Embodiment One of the present application;

[0024] Figure 4 FIG. 4 is an enlarged view of the structure at A in Embodiment One of the present application; Figure 1

[0025] Figure 5 FIG. 5 is a schematic diagram of the structure of the bending sleeve in Embodiment One of the present application;

[0026] Figure 6 FIG. 6 is a schematic diagram of the overall structure of the covered stent in Embodiment Two of the present application;

[0027] Figure 7 FIG. 7 is a schematic diagram of the structure of the connecting section in Embodiment Two of the present application;

[0028] Figure 8 FIG. 8 is a schematic diagram of the structure of the connecting sleeve in Embodiment Two of the present application;

[0029] Figure 9 ​Structure diagram of the first embodiment of the bending sleeve in the third embodiment of the present application;

[0030] Figure 10 Structure diagram of the second embodiment of the bending sleeve in the third embodiment of the present application;

[0031] Figure 11 Structure diagram of the third embodiment of the bending sleeve in the third embodiment of the present application;

[0032] Figure 12 Structure diagram of the overall structure of the covered stent in the fourth embodiment of the present application;

[0033] Figure 13 Structure diagram of the stent body in the fourth embodiment of the present application;

[0034] Figure 14 Structure diagram of another embodiment of the covered stent in the fourth embodiment of the present application;

[0035] Figure 15 Structure diagram of the covered stent after puncture in the fourth embodiment of the present application;

[0036] Figure 16 Structure diagram of the bending section in the fourth embodiment of the present application;

[0037] Figure 17 Structure diagram of the windowed section in the fourth embodiment of the present application;

[0038] Figure 18 Structure diagram of the overall structure of the covered stent in the fifth embodiment of the present application;

[0039] Figure 19 Structure diagram of the overall structure of the covered stent in the fifth embodiment of the present application from another perspective;

[0040] Figure 20 Structure diagram of the covered stent in the natural bending state in the fifth embodiment of the present application;

[0041] Figure 21 Structure diagram of the bending section in the fifth embodiment of the present application;

[0042] Figure 22 Structure diagram of the overall structure of the covered stent with the semi-release device in the fifth embodiment of the present application;

[0043] Figure 23 Structure diagram of the fifth embodiment of the present application; Figure 22 Enlarged view of B in the fifth embodiment of the present application;

[0044] Figure 24 Structure diagram of the covered stent in the semi-release state in the fifth embodiment of the present application.

[0045] The various tags in the drawings represent the following:

[0046] 10, covered stent; 100, stent body; 110, covering film; 120, braided wire; 200, keel; 210, connecting rod; 300, wave coil assembly; 310, bending section; 311, bending wave coil; 312, high wave section; 313, low wave section; 320, connecting section; 321, connecting wave coil; 3211, fixed wave form section; 3212, active wave form section; 322, supporting wave coil; 330, main body section; 331, main body wave coil; 400, sleeve assembly; 410, bending sleeve; 420, connecting sleeve; 430, pressure tooth groove; 431, first pressure groove; 432, second pressure groove; 433, inclined surface groove; 440, first pressure surface; 450, second pressure surface; 500, windowed section; 510, windowed wave coil; 520, puncture hole; 530, windowed area; 540, non-windowed area; 550, reinforcing wire; 600, recess portion; 610, recess bottom film; 620, through hole; 630, connecting tube; 640, developing ring; 650, recess support; 700, half-releasing device; 710, binding unit; 711, limiting ring; 712, binding wire; 713, buckle ring; 720, limiting unit; 721, limiting rod. DETAILED DESCRIPTION

[0047] Exemplary embodiments of the present application will be described herein below with reference to the accompanying drawings. While exemplary embodiments of the present application are illustrated, it is to be understood that the present application is not limited to the exemplary embodiments described herein, but can be implemented in various forms. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present application to those skilled in the art.

[0048] It is to be understood that the terms used herein are merely for the purpose of describing particular embodiments and are not intended to be limiting. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0049] Although the terms first, second, third, and the like can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be merely used to distinguish one element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first," "second," and the like are used herein to distinguish one element from another, without necessarily implying an order or sequence.

[0050] For ease of description, spatial relative terms can be used herein to describe the relationship between one element or feature to another element or feature as shown in the drawings, such as "inner", "outer", "inside", "outside", "lower", "below", "upper", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the drawings.

[0051] For ease of description, the following description uses the terms "distal" and "proximal", wherein "distal" refers to the end away from the heart, "proximal" refers to the end close to the heart, and the phrase "axial direction" should be understood in this patent to mean the direction in which the interventional instrument is pushed in and pushed out, and the direction perpendicular to the "axial direction" is defined as the "radial direction".

[0052] Embodiment one, the embodiment one of the present application provides a covered stent 10, as shown in Figure 1 With Figure 2 The covered stent 10 comprises a stent body 100 and a covering 110 arranged on the stent body 100, wherein the stent body 100 comprises a keel 200, a wave coil assembly 300 and a sleeve joint assembly 400, the wave coil assembly 300 is connected to the keel 200, and the sleeve joint assembly 400 is used to connect and fix the wave coil assembly 300 and the keel 200. The wave coil assembly 300 comprises at least one curved segment 310, which is used to adapt to the curved part of the blood vessel after the covered stent 10 is implanted in the blood vessel, especially the position with large curvature in the aortic arch.

[0053] In this embodiment, the wave coil assembly 300 comprises one curved segment 310, and in other embodiments, the wave coil assembly 300 can also be provided with multiple curved segments 310 according to actual needs, and the shapes of the multiple curved segments 310 can be the same or different to adapt to the shape of different blood vessel lumens.

[0054] The curved segment 310 comprises a plurality of curved wave coils 311, and the plurality of curved wave coils 311 are sequentially connected and fixed on the keel 200. The sleeve joint assembly 400 comprises a bending sleeve 410 for fixing the curved wave coil 311 and the keel 200, and the bending sleeve 410 is curved, so that the bending sleeve 410 drives the keel 200 and the curved wave coil 311 to bend to one side to make the whole curved segment 310 curved to adapt to the curved part of the blood vessel.

[0055] As Figure 3As shown, in this embodiment, a curved sleeve 410 is provided on the curved section 310, thereby causing the entire curved section 310 to be curved. During the fabrication of the covered stent 10, the covered stent 10 can be pre-formed into a curved shape according to the shape of the blood vessel, thereby adapting to the aortic vessel. Compared with the traditional straight covered stent 10, the pre-bent covered stent 10 can better adapt to the shape of the blood vessel, reduce the pressure on the inner wall of the blood vessel caused by the rebound force of the covered stent 10 itself, reduce the stimulation of the blood vessel by the covered stent 10, and prevent new ruptures in the blood vessel.

[0056] The bending direction and / or bending amplitude of each bending sleeve 410 can be set to be the same or different. The greater the bending amplitude of the bending sleeve 410, the larger the angle between the tangents at both ends of the bending sleeve 410. In this embodiment, the bending sleeve 410 is curved, and thus the bending amplitude of the bending sleeve 410 is its curvature. In actual clinical practice, different patients have different blood vessel shapes, especially after aortic dissection, the shape of the blood vessel usually changes. Since the covered stent 10 needs to be placed in the blood vessel for a long time, if the shape of the stent body 10 differs too much from the blood vessel, the stent body 100 will compress the inner wall of the blood vessel for a long time, causing discomfort to the patient, and even leading to changes in the vascular structure or new ruptures due to vascular fatigue. Therefore, using a universally sized vascular stent cannot meet the needs of all patients; it is necessary to select covered stents 10 of different shapes according to the different blood vessel shapes of different patients to adapt to diseased blood vessels with various degrees of curvature and different shapes.

[0057] The technical solution of this application allows for different bending directions and bending amplitudes of the bending sleeve 410, enabling flexible shaping of the bending segment 310 to adapt to blood vessels of various shapes. Doctors can select different shapes of covered stents 10 based on the morphology of the patient's diseased blood vessels. Furthermore, it allows for the customization of covered stents 10 according to the patient's specific blood vessel morphology, thereby reducing the pressure of the stent body 100 on the inner wall of the blood vessel. This ensures that even with long-term placement of the covered stent 10, the aorta will not develop new ruptures due to stimulation caused by the stent body 100, effectively mitigating the risks after endovascular repair of aortic dissection.

[0058] In this embodiment, as Figure 3 As shown, adjacent curved wave coils 311 are connected by connecting rods 210. The connecting rods 210 can be integrally woven with the curved wave coils 311, or they can be welded between two adjacent curved wave coils 311 to achieve the connection of the curved wave coils 311.

[0059] The curved wave coil 311 is fixedly connected to the connecting rod 210 by the bending sleeve 410. That is, the connecting rod 210 and a part of the curved wave coil 311 are connected and fixed by the bending sleeve 410, so that the connection between the curved wave coil 311 and the connecting rod 210 is more firm and stable.

[0060] In this embodiment, the keel 200 adopts a segmented design, with multiple connecting rods 210 sequentially connected to form a part of the keel 200. That is, the keel 200 is formed by sequentially connecting multiple connecting rods 210, and the connecting rods 210 and the curved wave coil 311 are integrally woven together. By adopting the above structural configuration, the keel 200 can be formed at the same radial height as the curved wave coil 311 during the weaving process. The keel 200 will not protrude relative to the curved section 310, thereby the pressure of the keel 200 on the inner wall of the blood vessel is smaller than that of a protruding keel 200, further reducing the stimulation of the covered stent 10 on the inner wall of the blood vessel.

[0061] In other embodiments, such as Figure 2 As shown, the keel 200 can also adopt an integrated design, in which the curved coils 311 are woven into shape separately, and then all the curved coils 311 are fixed in sequence by a strip keel 200. The keel 200 with the integrated design has higher strength, better flexibility, and a simpler manufacturing process and lower cost.

[0062] In this embodiment, the wave coil assembly 300 is formed by braiding filaments 120, which are nickel-titanium wires or other shape-memory metal wires. The curved wave coils 311 and connecting rods 210 are integrally woven together using the braiding filaments 120, with adjacent curved wave coils 311 connected end-to-end to the connecting rods 210 positioned between them. That is, the entire curved section 310 is integrally woven together by sequentially connecting curved wave coils 311 and connecting rods 210.

[0063] During the weaving process of the wave coil assembly 300, the sleeve assembly 400 is first placed on the braiding wire 120, and then woven into shape. The sleeve assembly 400 can be bent and shaped before or after being placed on the braiding wire 120. In order to facilitate the overall weaving of the bracket body 100, this embodiment adopts the method of placing the sleeve assembly 400 on the braiding wire 120 and then shaping it.

[0064] like Figure 4 As shown, the sleeve assembly 400 also includes a pressure groove 430, which is recessed towards the inside of the bending sleeve 410 and closely abuts against the braided wire 120 and the keel 200 of the wave coil assembly 300, thereby connecting and fixing the wave coil assembly 300 and the keel 200.

[0065] like Figure 5As shown, the socket assembly 400 includes two opposing first pressing surfaces 440 and second pressing surfaces 450, with at least one pressing surface having a pressing groove 430. That is, both the first pressing surface 440 and the second pressing surface 450 have pressing grooves 430, or one of the first pressing surface 440 and the second pressing surface 450 has a pressing groove 430.

[0066] By providing the pressure groove 430 only on the first pressing surface 440 or the second pressing surface 450, it is possible to achieve the purpose of pressing and fixing the wave coil assembly 300 and the keel 200 by the pressure groove 430, and the bending sleeve 410 bends toward the side with the pressure groove 430.

[0067] When both the first pressing surface 440 and the second pressing surface 450 are provided with pressing grooves 430, the bending sleeve 410 has pressing grooves 430 on both sides, so that the bending sleeve 410 can more firmly fix the wave coil assembly 300 and the keel 200.

[0068] In this embodiment, the shape of the bending sleeve 410 can be controlled by setting the number and position of the pressure grooves 430 on the bending sleeve 410. Specifically, the number of pressure grooves 430 on the first pressing surface 440 of the sleeve assembly 400 is the same as the number of pressure grooves 430 on the second pressing surface, or the number of pressure grooves 430 on the first pressing surface 440 of the sleeve assembly 400 is different from the number of pressure grooves 430 on the second pressing surface.

[0069] Specifically, a first pressing groove 431 is provided on the first pressing surface 440 of the bending sleeve 410, and a second pressing groove 432 is provided on the second pressing surface 450 of the bending sleeve 410. In this embodiment, the first pressing groove 431 and the second pressing groove 432 are staggered, and the number of the first pressing groove 431 is set to be less than the number of the second pressing groove 432.

[0070] Since the first pressure groove 431 and the second pressure groove 432 are misaligned, and the number of the first pressure groove 431 is less than the number of the second pressure groove 432, after the tooth pressure is tightened, the bending sleeve 410 will bend toward the first pressing surface 440 with fewer tooth grooves 430, forming a bent bending sleeve 410.

[0071] In this embodiment, the bending sleeve 410 of the sleeve assembly 400 is made of steel or other metal materials with good plastic deformation properties. Because the bending sleeve 410 has good plastic deformation properties, it exhibits good deformation capacity and stability after bending. Specifically, the bending sleeve 410 is formed by cutting a stainless steel tube.

[0072] Because the second pressure groove 432 facing the blood vessel increases the surface roughness of the bending sleeve 410, it increases the overall friction between the covered stent 10 and the inner wall of the blood vessel, thus making the covered stent 10 less prone to displacement after placement in the blood vessel. Furthermore, because the second pressure groove 432 is recessed towards the inside of the bending sleeve 410, and the bending sleeve 410 is curved, the side of the bending sleeve 410 can better conform to the inner wall of the curved blood vessel, thereby accelerating endothelial adhesion and further preventing the covered stent 10 from shifting under the flushing of blood. The axial width of the wave coil assembly 300 is 1.2 to 2 times the length of the sleeve assembly 400. That is, the axial width of the wave coil assembly 300 is greater than the length of the sleeve assembly 400, preferably 1.5 times.

[0073] In this embodiment, the bending sleeve 410 has four first pressing grooves 431 and five second pressing grooves 432. The multiple second pressing grooves 432 are evenly distributed on the second pressing surface 450. The first pressing grooves 431 are located in the middle of the first pressing surface 440, and the first pressing grooves 431 and second pressing grooves 432 are staggered. Specifically, the widths of the first pressing grooves 431 and second pressing grooves 432 are equal, and the ratio of the width of the first pressing groove 431 to the width of the second pressing groove 432 to the length of the sleeve assembly 400 is 5%-15%, preferably 8%. Therefore, the pressing grooves 430 will not affect the overall continuity of the end face of the sleeve assembly 400 due to excessive width, nor will they cause difficulties in bending due to excessive width.

[0074] In other embodiments, the number of first pressing grooves 431 and second pressing grooves 432 can be more or less. When the number of first pressing grooves 431 and second pressing grooves 432 provided on the bending sleeve 410 is more, for example, the number of first pressing grooves 431 is 6 and the number of second pressing grooves 432 is 7, the overall transition of the end face of the bending sleeve 410 is smoother, but the bending amplitude is smaller. When the number of first pressing grooves 431 and second pressing grooves 432 provided on the bending sleeve 410 is less, for example, the number of first pressing grooves 431 is 2 and the number of second pressing grooves 432 is 3, the crease at the bend on the end face of the bending sleeve 410 is larger, but the bending amplitude is greater.

[0075] In this embodiment, the bending sleeve 410 bends inward toward the stent body 100. The first pressing surface 440 is disposed inward toward the stent body 100, and the second pressing surface 450 is disposed inward toward the stent body 100. The number of first pressing grooves 431 on the first pressing surface 440 is less than the number of second pressing grooves 432 on the second pressing surface 450. By bending the aforementioned bending segment 310 in a direction away from the keel 200, it adapts to the shape of blood vessels, for example, at the aortic arch.

[0076] In other embodiments, the angle and degree of bending of the bending sleeve 410 can be adjusted to accommodate other blood vessels with curved sections, such as S-shapes or other irregular shapes.

[0077] It should be noted that the above examples in this embodiment are merely for the convenience of those skilled in the art to understand, and are not intended to limit this application.

[0078] Furthermore, such as Figure 2 and Figure 3 As shown, the curved waveband 311 includes a high-waveband 312 and a low-waveband 313 connected end to end. The high-waveband 312 is located on the side closer to the keel 200, and the low-waveband 313 is located on the other side away from the keel 200. The axial height of the high-waveband 312 is greater than the axial height of the low-waveband 313.

[0079] Specifically, when the covered stent 10 is implanted at the aortic arch, the covered stent 10 is generally curved. The side of the covered stent 10 facing the branch vessels of the aortic arch is typically defined as the greater curvature side of the covered stent 10, and the side of the covered stent 10 away from the branch vessels of the aortic arch is defined as the lesser curvature side of the covered stent 10. In this application, the high-band 312 and the keel 200 are positioned on the greater curvature side of the covered stent 10, and the low-band 313 is positioned on the lesser curvature side of the covered stent 10.

[0080] Since the waveband corresponding to the small bend side is the low waveband 313, there is a larger displacement margin between adjacent wavebands. When the covered stent 10 is implanted in the blood vessel and is set in a curved shape, the small bend side has better compliance.

[0081] In summary, the above-described technical solution of this application enables the covered stent to be configured into a preset curved shape according to the shape of the blood vessel, thereby adapting to the aortic vessel, reducing the pressure of the covered stent on the inner wall of the blood vessel, reducing the stimulation of the covered stent on the blood vessel, and preventing new ruptures in the blood vessel.

[0082] Embodiment 2: Embodiment 2 of this application provides a covered stent 10, such as... Figure 6 As shown, the similarities between Embodiment 2 and Embodiment 1 will not be repeated. The difference between Embodiment 2 and Embodiment 1 is that the support body 100 further includes a connecting section 320 disposed near the proximal end of the curved section 310 and a main body section 330 disposed at the distal end of the curved section 310. Specifically, the main body section 330 is generally cylindrical. The connecting section 320 includes a connecting wave coil 321 and a supporting wave coil 322. The connecting wave coil 321 is used to connect the delivery device and the release device, and the supporting wave coil 322 is used to support the proximal edge of the membrane 110.

[0083] In this embodiment, the stent body 100 includes not only a curved segment 310 but also a cylindrical main body segment 330, which is disposed at the distal end of the curved segment 310. In other embodiments, the cylindrical main body segment 330 may also be disposed at the proximal end of the curved segment 310, or both the proximal and distal ends of the curved segment 310 may have the main body segment 330, depending on the patient's blood vessel shape, thereby adapting to the needs of different patients.

[0084] like Figure 7 As shown, the support wave 322 is disposed between the membrane 110 and the connecting wave 321. The support wave 322 is disposed on the inner side of the membrane 110 and is fixed to the membrane 110 by stitching to enhance the support strength of the proximal end of the membrane 110 and prevent internal leakage.

[0085] Among them, the wire diameter of the supporting wave coil 322 is smaller than that of the connecting wave coil 321. Since the covered stent 10 is implanted into the blood vessel, the supporting wave coil 322 supports the covered stent 110 so that the covered stent 110 adheres to the inner wall of the blood vessel. Therefore, the radial support force of the supporting wave coil 322 will directly affect the pressure of the covered stent 10 on the inner wall of the blood vessel.

[0086] In this embodiment, by setting the wire diameter of the support wave coil 322 to be smaller than that of the connecting wave coil 321, the radial support force of the support wave coil 322 is reduced, making the contact surface between the support wave coil 322 and the inner wall of the blood vessel softer and causing less stimulation to the inner wall of the blood vessel.

[0087] Furthermore, in this embodiment, the wavenumber of the supporting wavering coil 322 is set to be greater than that of the connecting wavering coil 321. Since the supporting wavering coil 322 is positioned between the covering stent 110 and the connecting wavering coil 321, and the radial support force of the connecting wavering coil 321 is greater than that of the supporting wavering coil 322, the connecting wavering coil 321 supports the supporting wavering coil 322 from the inside after the covered stent 10 is fully released. The supporting wavering coil 322 can disperse the radial support force provided by the connecting wavering coil 321, resulting in a more uniform pressure on the vascular wall.

[0088] The connecting waveform 321 is partially connected to the covering film 110. Specifically, the proximal end of the connecting waveform 321 is recessed inside the covering film 110. The connecting waveform 321 includes several fixed waveform segments 3211 that are fixedly connected to the covering film 110 and at least one movable waveform segment 3212 that is movably connected to the covering film 110.

[0089] In this embodiment, the connecting coil 321 includes at least three movable waveform segments 3212 that are movably connected to the covering film 110. The at least three movable waveform segments 3212 are evenly arranged along the circumferential direction of the covering film 110. The three movable waveform segments 3212 are used to connect to the post-release device of the conveyor and are released after the covering film support 10 is positioned.

[0090] Before the rear release device of the conveyor releases the connecting coil 321, the movable waveform segment 3212 is restrained by the rear release device and thus restrained at the middle position of the support body 100. Since the movable waveform segment 3212 is movably connected to the film 110, the film 110 is displaced towards the inward direction of the film support 10 under the pull of the movable waveform segment 3212. The fixed waveform segment 3211 is fixedly connected to the film 110, and under the action of its own elastic force, the fixed waveform segment 3211 generates an outward radial supporting force on the film 110, thereby expanding the film 110 body.

[0091] Therefore, before the post-release device releases the connecting coil 321, the fixed waveform segment 3211 expands the covering 110 outward, while the movable waveform segment 3212 pulls the covering 110 inward, causing the front end of the covered stent 10 to be in a semi-released state. In the semi-released state, the covered stent 10 is partially deployed, thus the instantaneous force on the vascular wall is small upon full release, protecting the patient's blood vessels and preventing vascular spasm or even new vascular rupture.

[0092] Furthermore, the main body segment 330 includes a plurality of main body wave coils 331 connected sequentially to the keel 200, and the socket assembly 400 also includes a connecting sleeve 420 for connecting adjacent main body wave coils 331.

[0093] like Figure 8 As shown, the connecting sleeve 420 also includes a first pressing surface 440 and a second pressing surface 450. A first pressing groove 431 is provided on the first pressing surface 440, and a second pressing groove 432 is provided on the second pressing surface 450. The connecting sleeve 420 differs from the bending sleeve 410 in that the connecting sleeve 420 has the same number of first pressing grooves 431 and second pressing grooves 432, and the first pressing grooves 431 and second pressing grooves 432 are arranged opposite to each other. After being formed by tooth pressing, the connecting sleeve 420 is generally flat and cylindrical. Therefore, the main body section 330 is also generally cylindrical.

[0094] In this embodiment, the main body coil 331 located at the distal end of the stent body 100 has a smaller radial dimension than the main body coil 331 located at the proximal end of the stent body 100. This allows for better adaptation to the vascular diameter of the aortic arch or other vascular locations.

[0095] In other embodiments, the different main wave loops 331 can also be configured to have the same size, or the main wave loop 331 located at the far end of the support body 100 can have a larger radial dimension than the main wave loop 331 located at the near end of the support body 100. The specific selection is based on actual needs.

[0096] In summary, the stent body 100 of this embodiment includes not only the curved section 310 but also the main body section 330. Since the main body section 330 is cylindrical, the length and number of the curved section 310 and the main support section can be matched to make it more adaptable to patients with different blood vessel shapes through flexible configuration, thereby making the covered stent 10 more adaptable and reducing the pressure of the covered stent 10 on the inner wall of the patient's blood vessel.

[0097] Embodiment 3: Embodiment 3 of this application provides a covered stent 10, such as... Figure 9 to Figure 11 As shown, the similarities between Embodiment 3 and Embodiment 1 will not be repeated. The difference between Embodiment 3 and Embodiment 1 is that the number of pressure grooves 430 on the first pressing surface 440 of the sleeve assembly 400 is the same as the number of pressure grooves 430 on the second pressing surface 450.

[0098] In this embodiment, the bending sleeve 410 can be bent toward the inside of the stent body 100 or toward the outside of the stent body 100, so that the formed covered stent 10 can be adapted to the shape of the patient's blood vessels, and the specific setting is based on the shape of the patient's blood vessels.

[0099] Furthermore, the number of first pressure grooves 431 on the bending sleeve 410 is the same as the number of second pressure grooves 432, but their shapes are different.

[0100] like Figure 9 As shown, when the same number of first pressure grooves 431 and second pressure grooves 432 are provided on the bending sleeve 410, in order for the bending sleeve 410 to bend according to the preset bending degree, the groove depth of the first pressure groove 431 on the bending sleeve 410 is different from the groove depth of the second pressure groove 432. The groove depth of the first pressure groove 431 is greater than the groove depth of the second pressure groove 432. The bending sleeve 410 bends toward the side with a larger groove depth of the pressure groove 430, that is, it bends toward the direction of the first pressure groove 431.

[0101] In other implementations, such as Figure 10 As shown, the tooth height of the first pressing groove 431 on the bending sleeve 410 is different from the groove width of the second pressing groove 432. The groove width of the first pressing groove 431 is smaller than the groove width of the second pressing groove 432. The bending sleeve 410 bends toward the side with the smaller groove width of the pressing groove 430, that is, it bends toward the direction of the first pressing groove 431.

[0102] In other implementations, such as Figure 11 As shown, the pressure grooves 430 at both ends of the bending sleeve 410 are inclined grooves 433, and the inclination of the inclined grooves 433 is set according to the actual bending degree required by the bending sleeve 410.

[0103] It should be noted that the shape of the bending sleeve 410 described above in this application is merely an example and does not constitute a limitation. Any bending sleeve 410 obtained by adjusting the shape, number, and position of the pressure groove 430 is within the protection scope of this application.

[0104] Embodiment 4: Embodiment 4 of this application provides a covered stent 10, such as... Figure 12 to Figure 13 As shown, the similarities between Embodiment 4 and Embodiment 1 will not be repeated. The difference between Embodiment 4 and Embodiment 1 is that the stent body 100 includes a connecting segment 320, a fenestrated segment 500, and a curved segment 310. The connecting segment 320 and the curved segment 310 are respectively disposed at the proximal and distal ends of the fenestrated segment 500. The curved segment 310 is used to adapt the covered stent 10 to locations with a large degree of curvature near the aortic arch after implantation into the blood vessel.

[0105] The covered stent 10 of this embodiment is used for the treatment of vascular lesions across and near the aortic arch. After the covered stent 10 is placed in the blood vessel, it penetrates the ascending aorta and the descending aorta. The connecting segment 320, the fenestrated segment 500, and the tortuous segment 310 are located at the ascending aorta, the aortic arch, and the descending aorta, respectively, after the covered stent 10 is placed in the blood vessel. Thus, the covered stent 10 can be used to isolate vascular lesions across the aorta, such as aortic aneurysms and aortic dissections.

[0106] In other embodiments, such as Figure 14 As shown, the connecting segment 320 and the fenestrated segment 500 can also be respectively set at the proximal and distal ends of the curved segment 310, so that the curved segment 310 can isolate vascular lesions in the ascending aorta and better deal with vascular lesions mainly located in the ascending aorta.

[0107] The windowed section 500 includes multiple windowed corrugations 510, which are spaced apart and connected by a covering film 110. The distance between adjacent windowed corrugations 510 is greater than the distance between adjacent curved corrugations 311, and a gap is reserved between adjacent windowed corrugations 510 to puncture the covering film 110 for window opening. Figure 15 As shown, the fenestrated segment 500 forms a puncture hole 520 after the puncture covering 110 is opened. The puncture hole 520 is used for the implantation of a branch stent (not shown in the figure), which corresponds to a branch vessel on the aortic arch. On the other hand, since the fenestrated segment 500 is positioned at the aortic arch, the spaced fenestrated coils 510 are connected by the covering 110, which ensures the flexibility of the fenestrated segment 500 and reduces the stimulation of the stent body 100 on the inner wall of the blood vessel.

[0108] In this embodiment, the fenestration segment 500 includes at least four fenestration wavebands 510. During fenestration, the puncture instrument punctures between adjacent fenestration segment wavebands to form three puncture holes 520, which are used to adapt to three branch vessels corresponding to the aortic arch.

[0109] Because the covered stent 10 needs to cover lesions such as aortic dissection after being placed in a blood vessel, when the lesion is located at the aortic arch or across a tortuous section of the aortic arch, the straight-shaped covered stent 10 will generate elastic recoil force and stress after being passively bent, which can easily lead to new aortic ruptures. In addition, to ensure that the covered stent 10 can completely cover the lesion, a keel 200 is required to prevent stent shortening and avoid the stent failing to cover the lesion due to shortening.

[0110] The curved section 310 includes multiple curved coils 311 and a keel 200. The multiple curved coils 311 are sequentially connected and fixed on the keel 200. A bending sleeve 410 is fitted on the keel 200 between adjacent curved coils 311. The bending sleeve 410 is curved so that the keel 200 bends with the bending sleeve 410, thereby causing the curved section 310 to bend, thus adapting to the curved part inside the blood vessel.

[0111] This embodiment incorporates a curved section 310 on the stent body 100 to conform to the shape of the blood vessel, reducing damage to the blood vessel caused by the stent's straightening force. Furthermore, it reduces the compressive force between the outer side of the stent body 100 and the blood vessel, preventing structural changes or rupture of the blood vessel due to fatigue.

[0112] Combination Figure 15 As shown, the open-window wave coil 510 is formed by braiding wire 120, with the ends of the braided wire 120 connected, and the connection of the braided wire 120 is fixedly connected by connecting sleeve 420.

[0113] Among them, such as Figure 16 As shown, the keel 200 of the curved waveguide 311 is correspondingly positioned on the large bend side of the membrane support 10. The curved waveguide 311 includes a high-band 312 and a low-band 313 connected end to end. The high-band 312 is located on the side closer to the keel 200, and the low-band 313 is located on the other side away from the keel 200, that is, the low-band 313 is correspondingly positioned on the small bend side of the membrane support 10. The axial height of the high-band 312 is greater than the axial height of the low-band 313, and the axial height of the windowed waveguide 510 is less than or equal to the axial height of the low-band 313.

[0114] This application, by placing the low-profile band 313 on the side of the minor bend, allows for a larger displacement margin between adjacent curved bands 311. When the covered stent 10 is implanted into the blood vessel and positioned in a curved manner, the side of the minor bend exhibits better compliance. Furthermore, since the curvature of the aortic arch is greater than that of the ascending and descending aorta, setting the axial height of the fenestrated band 510 to be less than or equal to the axial height of the low-profile band 313 can avoid adjacent bands colliding and thus limiting curvature. This allows the fenestrated segment 500 to achieve a greater degree of curvature and better conform to the inner wall of the blood vessel at the aortic arch.

[0115] In addition, the axial height of the fenestrated waveband 510 is less than or equal to the axial height of the low-band 313, so that the gap between adjacent fenestrated wavebands 510 is larger, which can reserve a larger position for the puncture instrument to open the window, making it easier for the doctor to adjust the puncture position during the operation; at the same time, it can reduce the release accuracy of the covered stent 10, thereby reducing the difficulty of the operation.

[0116] like Figure 17 As shown, the fenestration coil 510 includes a fenestration area 530 and a non-fenestration area 540 for puncture and fenestration. The fenestration area 530 is located on the greater curvature side of the covered stent 10, and during implantation, the fenestration area 530 is positioned at the branch vessel opening of the aortic arch. A reinforcing wire 550 is disposed on the covered stent 110 within the non-fenestration area 540, and the reinforcing wire 550 is arranged radially around the covered stent 110. In this embodiment, multiple reinforcing wires 550 are disposed on the covered stent 110, and the multiple reinforcing wires 550 are axially spaced.

[0117] Because the curved section 310 is bent under the action of the bending sleeve 410, the stress on the curved section 310 increases when the covered stent 10 is inserted into the sheath, making it difficult to insert the curved section 310 into the sheath. Since the friction between the covered stent 10 with the curved section 310 and the sheath is greater, the covered stent 10 is prone to displacement during release. This application provides multiple reinforcing wires 550 on the covering 110 to balance the forces on the curved section 310 and other non-curved sections of the covered stent 10, making the assembly and release of the covered stent 10 more stable and smooth.

[0118] Furthermore, because the covered stent 10 has a bending sleeve 410, the endothelial adhesion of the covered stent 10 with the bending sleeve 410 is faster than that of a traditional stent. However, the bending sleeve 410 is located on one side of the keel 200. On the other side of the covered stent 10 where the keel 200 is not located, especially in the vascular area covered by the non-fenestrated area 540, the anchoring force between the covered stent 10 and the blood vessel is relatively weak. After the covered stent 10 has been placed in the blood vessel for a long time, there is a risk of displacement, shortening, or other adverse events in the non-fenestrated area 540. This application adds multiple axially spaced reinforcing wires 550 within the non-fenestrated area 540, which can increase the overall support strength of the non-fenestrated area 540 and the fenestrated area 530 after puncture, and prevent displacement, shortening, or even leakage of some segments of the covered stent 10.

[0119] Since the strength of the endovascular graft 110 is affected after fenestration, for vascular lesions spanning the aortic arch and near the aortic arch, it is necessary to consider both the blood flow of the branches above the aortic arch and the supporting strength of the endovascular graft 10. Therefore, in this embodiment, reinforcing wires 550 are provided on the endovascular graft 110 in the non-fenestration area 540 to increase the overall strength of the endovascular graft 110 after fenestration, preventing the endovascular graft 110 from tearing due to insufficient strength under long-term blood flow after puncture, and ensuring the strength of the endovascular graft 110 in the fenestration segment 500 after long-term implantation of the endovascular graft 10. In this embodiment, the bending direction and / or bending amplitude of each bending sleeve 410 can be the same or different. Since the vascular shapes of different patients are different, especially when the vascular lesion is located near the aortic arch, the vessels near the aortic arch are usually deformed due to the lesion. The above-described technical solution of this application allows for the individual setting of the shape of each bending sleeve 410, so that after the stent body 100 is formed, it adapts to the shape of the patient's vascular lumen, further reducing the stimulation of the stent body 100 on the blood vessel and reducing the probability of secondary damage to the patient's blood vessel.

[0120] like Figure 12 As shown, the connecting section 320 includes a connecting wave ring 321 and a supporting wave ring 322. The connecting wave ring 321 is a bare wave ring. The distal end of the connecting wave ring 321 is connected to the proximal end of the covering film 110. The proximal end of the connecting wave ring 321 is used to connect the delivery device after the conveyor. The supporting wave ring 322 is used to support the proximal edge of the covering film 110.

[0121] In this embodiment, the stent body 100 is provided with a fenestrated section 500 and a curved section 310. A puncture cover 110 position is reserved on the fenestrated section 500, and an implantation position for the branch stent is reserved. By using the branch stent to correspond to the branch vessels on the aortic arch, the blood flow of the branch vessels on the aortic arch is not obstructed after the covered stent 10 is implanted into the vessel, thereby adapting to vascular lesions across and near the aortic arch.

[0122] Furthermore, the curved section 310 can set the covered stent 10 into a preset curved shape according to the shape of the blood vessel, thereby adapting it to the blood vessels near the aortic arch, reducing the pressure of the covered stent 10 on the inner wall of the blood vessel, reducing the stimulation of the covered stent 10 on the blood vessel, and preventing new ruptures in the blood vessel.

[0123] Example 5: Example 5 of this application provides a covered stent 10, such as... Figure 18 to Figure 19 As shown, the similarities between Embodiment 5 and Embodiment 1 will not be repeated. The difference between Embodiment 5 and Embodiment 1 is that a groove 600 is provided on the curved section 310, and the groove 600 is recessed towards the inner side of the stent body 100. The covered stent 10 of this embodiment is used for vascular treatment around the aortic arch. After the covered stent 10 is inserted into the blood vessel, the groove 600 is correspondingly positioned at the aortic arch. The groove 600 is formed on the covered 110, and the groove 600 forms a roughly rectangular shape on the covered 110, that is, when the covered 110 is unfolded, it has a rectangular window.

[0124] The recessed portion 600 includes a recessed base membrane 610 connected to the cover membrane 110, a through hole 620 disposed between the recessed base membrane 610 and the cover membrane 110, and a connecting tube 630 communicating with the through hole 620. After the curved section 310 is implanted into the blood vessel, the recessed portion 600 is correspondingly positioned at the aortic arch, and the connecting tube 630 is used to connect to the branch stent corresponding to the branch blood vessel on the aortic arch.

[0125] In this embodiment, the connecting tube 630 is fixedly connected to the through hole 620 by suturing. The groove portion 600 includes three connecting tubes 630, with two connecting tubes 630 disposed at the proximal end of the groove portion 600 and one connecting tube 630 disposed at the distal end of the groove portion 600. The three connecting tubes 630 correspond to the three branch vessels on the aortic arch, respectively. A contrast ring 640 is sutured to the edge of the through hole 620 to visualize the position of the connecting tubes 630, facilitating the connection between the branch stent and the covered stent 10 and the placement of the branch vessels.

[0126] The edge of the grooved bottom membrane 610 is connected to the covering membrane 110 by stitching, and a grooved support member 650 is provided on the grooved bottom membrane 610. The grooved support member 650 is a support rod connected to the curved section bracket, and the grooved bottom membrane 610 is stitched to the support rod. Alternatively, the grooved support member 650 is a stitch sewn onto the grooved bottom membrane 610, which is used to increase the supporting strength of the bottom membrane.

[0127] like Figure 20 and Figure 21As shown, the stent body 100 includes a keel 200, and the curved section 310 includes multiple curved coils 311. The multiple curved coils 311 are sequentially connected and fixed on the keel 200. Adjacent curved coils 311 are connected by a bending sleeve 410, which is fitted onto the keel 200. The bending sleeve 410 is curved, thereby causing the keel 200 and the curved coils 311 to bend the entire curved section 310 to adapt to the shape of the aortic arch.

[0128] The groove 600 is located on the side near the keel 200. Because the keel 200... Since the covered stent 10 of this embodiment is implanted at the aortic arch, and the blood vessels at the aortic arch have a large degree of curvature, by setting the keel 200 towards the large curvature side of the aortic arch, the overall support of the covered stent 10 for the aortic arch can be enhanced, preventing displacement of the covered stent 10. However, after long-term implantation of the covered stent 10 into the blood vessel, the rebound force of the keel 200 can irritate the inner wall of the blood vessel, easily leading to new aortic ruptures. This application uses a bending sleeve 410 to drive the keel 200, causing the entire curved section 310 to bend, to better conform to the shape of the blood vessel. Not only does the setting of the keel 200 ensure the overall support of the covered stent 10 to protect the blood vessel, but the use of the bending sleeve 410 also reduces the elastic recoil force of the keel 200 and the curved section 310, as well as the resulting stress, preventing new aortic ruptures.

[0129] The curved wave loop 311 includes a high-wave band 312 and a low-wave band 313 connected end to end. The high-wave band 312 is located on the side closer to the keel 200, and the low-wave band 313 is located on the side farther from the keel 200. The axial height of the high-wave band 312 is greater than the axial height of the low-wave band 313. In other embodiments, the axial height of the high-wave band 312 is greater than or equal to the axial height of the main wave loop 331, and the distance between adjacent high-wave bands 312 is larger, so that the branch stent can pass through the adjacent curved wave loop 311 more easily, thereby facilitating the implantation of the branch stent, saving surgical time, and improving the success rate of the surgery.

[0130] Compared to the existing covered stent 10, this embodiment features a groove 600 on the curved section 310, which corresponds to the aortic arch after the covered stent 10 is implanted into the blood vessel. A connecting tube 630 is provided within the groove 600, which is used to adapt to a branch stent, connecting the covered stent 10 and the branch blood vessels on the aortic arch. Furthermore, the curved coil 311, supported by the keel 200, provides better support to the inner wall of the blood vessel at the aortic arch. The curved section 310 also features a curved bend sleeve 410, making the entire curved section 310 curved to fit the shape of the aortic arch, reducing the pressure exerted by the covered stent 10 on the inner wall of the blood vessel, minimizing stimulation of the blood vessel, and preventing new ruptures.

[0131] Around the aortic arch, the vascular lesion can be isolated and treated by using the non-grooved portion 600 of the covered stent 10, thus providing good adaptation to the vascular lesions around the aortic arch. This balances blood flow to the branches above the aortic arch with the treatment of vascular lesions around the aortic arch.

[0132] In this embodiment, the stent body may also include multiple curved segments 310, and the groove portion 600 is disposed on one of the curved segments 310, thereby adapting to vascular lesions in different parts of the aortic arch, such as the ascending aorta.

[0133] like Figure 20 As shown, the support body 100 also includes a main body segment 330, which includes a plurality of spaced-apart main body corrugated coils 331. The sleeve assembly 400 includes a connecting sleeve 420 for fixing the main body corrugated coils 331 to the keel 200. The covering film 110 is sewn and fixed to the main body corrugated coils 331 by sutures. Figure 8 As shown, the connecting sleeve 420 is provided with a pressure groove 430. When the covering film 110 is fixed on the main body wave ring 331, the suture is bound in the pressure groove 430 on the connecting sleeve 420. The suture stuck in the pressure groove 430 can increase its fixing strength and prevent relative movement between the covering film 110 and the main body wave ring 331 due to the pulling force.

[0134] In this embodiment, the stent body 100 also includes a connecting section 320, which is connected to the keel 200 via a connecting sleeve 420. Since the curved coil 311 at the groove 600 is separately disposed from the covering 110, this embodiment connects the curved section 310 and the connecting section 320 via the keel 200, making the transition of the curved coil 311 on the groove 600 smoother. This avoids the curved coil 311 from tilting outwards when the covered stent 10 is bent, which would cause excessive stimulation of the vascular wall by the curved coil 311, thereby avoiding other adverse consequences such as new ruptures in the blood vessel.

[0135] like Figure 22 to Figure 24 As shown, a semi-release device 700 is provided on the support body 100. The semi-release device 700 includes a restraint unit 710 for restraining the support body 100 and a limiting unit 720 movably connected to the restraint unit 710. The limiting unit 720 controls the release of the restraint unit 710.

[0136] The restraint unit 710 includes a limiting ring 711 disposed on the wave coil assembly 300 and a restraint line 712 passing through the limiting ring 711. The restraint unit 720 includes a limiting rod 721. At least two limiting rings 711 are disposed on the wave coil assembly 300. The two ends of the restraint line 712 pass through the limiting rings 711 respectively. The restraint line 712 and the limiting rod 721 are adapted to each other and are used to circumferentially restrain the film-coated support 10.

[0137] In this embodiment, the restraint unit 710 includes a plurality of limiting rings 711 arranged circumferentially along the film-coated support 10 to make the restraint line 712 more securely fixed to the film-coated support 10. The limiting rings 711 are sleeved on the wave coil assembly 300 and sewn and fixed to the film 120.

[0138] Both ends of the binding line 712 are provided with buckles 713. The limiting rod 721 is used to simultaneously pass through the buckles 713 at both ends of the binding line 712. At the same time, the length of the binding line 712 is less than the perimeter of the cross-section of the support body 100.

[0139] In other embodiments, the limiting unit 720 may also include a limiting wire for simultaneously threading the buckles 713 at both ends of the binding line 712.

[0140] In this embodiment, a semi-release device 700 is provided on the surface of the film-coated support 10. After the film-coated support 10 is fully released from the conveyor, it is in a semi-released state under the constraint of the semi-release device 700. In the semi-released state, the film-coated support 10 is under the circumferential constraint of the binding line 712. At this time, the binding line 712 binds the film-coated support 10 in the circumferential direction, and the limiting rod 721 passes through the buckles 713 at both ends of the binding line 712.

[0141] When the covered stent 10 is in a partially released state, it is not adhering to the vessel wall. The operator can adjust the axial and circumferential positions of the covered stent 10 according to the actual situation. After accurate positioning, the constraint of the partially released device 700 is released, allowing the covered stent 10 to unfold and adhere to the vessel wall. When releasing the constraint of the partially released device 700, the limiting rod 721 is pulled out from the loops at both ends of the binding line 712. The unconstrained covered stent 10 expands under its own elastic force, thus adhering completely to the vessel wall.

[0142] In this embodiment, each wave coil assembly 300 is provided with a restraint unit 710 so that the film-coated support 10 is subjected to uniform force when it is in a semi-released state.

[0143] Because the groove portion 600 of the covered stent 10 in this embodiment needs to correspond with the branch vessels of the aortic arch when it is implanted into a blood vessel, and it is difficult to ensure that the groove portion 600 is aligned with the branch vessels of the aortic arch when the covered stent 10 is released, this embodiment provides a semi-release device 700 on the covered stent 10 to adjust the position of the covered stent 10.

[0144] Because the curved section 310 of this application is provided with a groove 600, and the groove 600 is provided on the covering 110 and recessed into the stent body 100, the keel 200 located in the groove 600 is in direct contact with the inner wall of the blood vessel. After the covered stent 10 is unfolded and attached to the wall, the stent body 100 with the bending sleeve 410 has a stronger anchoring force, which can prevent the covered stent 10 from shifting under long-term blood flow.

[0145] However, due to the curved section 310 of the covered stent 10, compared to traditional straight stents, if the covered stent 10 is not positioned accurately during release, the curved section 310 will prematurely adhere to the vessel wall, making it difficult to adjust the position of the covered stent 10. This application incorporates a semi-release device 700 on the covered stent 10. After being released from the delivery system, the covered stent 10 is in a semi-released state, at which point the curved section 310 is restrained and not yet adhered to the vessel wall. Therefore, the covered stent 10 can move without scraping the vessel wall. The operator can adjust the axial and circumferential positions of the covered stent 10 as needed, ensuring that the groove 600 is aligned with the branch vessels above the aortic arch.

[0146] Furthermore, this application uses the bending sleeve 410 to bend the entire bending section 310, making the bending of the bending section 310 more uniform and facilitating a smoother transition of the limiting rod 721 of the restraining unit 710 as it passes through the limiting ring 711. Simultaneously, the restraining line 712 can be hooked into the pressure groove 430 on the bending sleeve 410, preventing the restraining line 712 from shifting during the movement of the limiting rod 711.

[0147] In this embodiment, when the covered stent 10 is in a semi-released state, the buckles 713 at both ends of the restraint line 712 are located in the middle of the groove 600, making the force on the groove 600 more uniform. At the same time, the keel 200 is axially arranged along the middle of the groove 600. When the restraint line 712 is in a semi-released state, it can hook into the pressure groove 430 on the bending sleeve 410. The limiting rod 721 passes through the buckles 713 of the limiting unit 720 in sequence. At this time, the limiting rod 721 is bent in the same shape as the keel 200 under the restraint of multiple sets of buckles 713, thereby preventing the limiting rod 721 from scratching the blood vessel wall when the covered stent 10 is adjusted in the semi-released state, ensuring the safety of the operation.

[0148] Through the above-described technical solution of this embodiment, by providing a groove 600 corresponding to the aortic arch on the curved segment 310, the covered stent 10 can effectively address vascular lesions around the aortic arch. Furthermore, the curved segment 310 can well adapt to the shape of the aortic arch, reducing the irritation of the covered stent 10 to the vascular wall. This balances blood flow to the branches of the aortic arch with the treatment of vascular lesions around the aortic arch.

[0149] In summary, the covered stent prepared by the above-described preparation method of this application has good physical properties. The stent can be made in a targeted manner according to the shape of the specific diseased blood vessel, so that the stent fits the shape of the blood vessel itself better. It can reduce the elastic recoil force generated by the passive bending of existing stents in bending parts such as the aortic arch, and the stress generated therefrom, thereby reducing and preventing new aortic ruptures caused by stents.

[0150] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A covered stent, comprising a stent body and a covering film disposed on the stent body, characterized in that, The support body includes a keel, a corrugated coil assembly, and a sleeve assembly for connecting the keel and the corrugated coil assembly; the corrugated coil assembly includes at least one curved section connected to the keel, the curved section including a plurality of curved corrugated coils sequentially arranged on the keel; the sleeve assembly includes a plurality of curved sleeves for connecting the curved corrugated coils and the keel; the corrugated coil assembly also includes a fenestration section for the membrane puncture. The sleeve assembly further includes a toothed groove recessed towards the inside of the bending sleeve, the toothed groove being used to connect and fix the bending section and the keel. The bending sleeve includes a first pressing surface and a second pressing surface disposed opposite to each other, and the toothed groove is disposed on the first pressing surface and / or the second pressing surface.

2. The covered stent according to claim 1, characterized in that, The window segment includes multiple windowed wave rings spaced apart, and adjacent windowed wave rings are connected by the covering film.

3. The covered stent according to claim 2, characterized in that, The fenestration section includes a fenestration area for puncture and a non-fenestration area. The fenestration area is located on the side close to the keel, and the non-fenestration area is located on the side away from the keel. Reinforcing wires are provided on the film in the non-fenestration area.

4. The covered stent according to claim 2, characterized in that, The curved waveband includes a high-wave band and a low-wave band connected end to end. The high-wave band is located on the side closer to the keel, and the low-wave band is located on the side farther from the keel. The axial height of the high-wave band is greater than the axial height of the low-wave band.

5. The covered stent according to claim 4, characterized in that, The axial height of the windowed waveband is less than or equal to the axial height of the low-band waveband.

6. The covered stent according to claim 1, characterized in that, The bending directions and / or bending amplitudes of the multiple bending sleeves may be the same or different.

7. The covered stent according to claim 1, characterized in that, The wave coil assembly also includes a connecting section located near the proximal end of the support body. The connecting section includes a connecting wave coil and a supporting wave coil. The distal end of the connecting wave coil is connected to the proximal end of the covering film. The proximal end of the connecting wave coil is used to connect to the delivery device and the supporting wave coil is used to support the proximal edge of the covering film.

8. The covered stent according to claim 1, characterized in that, Adjacent curved coils are connected by connecting rods, and the curved coils are fixedly connected to the connecting rods by the bending sleeves. Multiple connecting rods are connected in sequence to form part of the keel. The curved coils and the connecting rods are woven together by braided yarn, and adjacent curved coils are connected end to end by the connecting rods.

9. The covered stent according to claim 1, characterized in that, The number and / or shape of the pressure grooves on the first pressing surface of the bending sleeve are different from those on the second pressing surface.

10. The covered stent according to claim 9, characterized in that, The pressure groove includes a first pressure groove disposed on the first pressing surface and a second pressure groove disposed on the second pressing surface; the number of the first pressure grooves is less than the number of the second pressure grooves, and the first pressure grooves and the second pressure grooves are offset.

11. The covered stent according to claim 10, characterized in that, The bending sleeve is bent toward the inside of the bracket body; the first pressing surface is disposed toward the inside of the bracket body, and the second pressing surface is disposed toward the outside of the bracket body.

Images