Covered stent and delivery system

Abstract

The application provides a covered stent and a delivery system. The covered stent comprises a covered stent body, a first wave coil and a connecting part. The covered stent body comprises an end section with an open end part. The first wave coil is connected with the end section. The connecting part is formed on at least one of the end section and the first wave coil, and is used for connecting with a delivery device. An end surface of the end section comprises a first partial end surface and a second partial end surface which are connected with each other. The first partial end surface and the second partial end surface are arranged along the circumference of the covered stent body. Compared with the second partial end surface, the first partial end surface protrudes in a direction away from the covered stent. An outer protruding area is formed between the first partial end surface and the axial direction of the second partial end surface. The connecting part is at least partially arranged in the outer protruding area. The axial area of the connecting part is located in the axial area of the end section. The covered stent and the delivery system can improve the wall-adhesion and the occlusion effect of the covered stent.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a covered stent and a delivery system. BACKGROUND

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

[0003] Traditional open surgery for aortic aneurysm and aortic dissection has high trauma, high mortality, long operation time, high incidence of postoperative complications and high surgical difficulty. Endovascular treatment has the characteristics of less trauma, fewer postoperative complications, shorter operation time and lower surgical difficulty, and has gradually become the main method for treating aortic aneurysm and aortic dissection. Endovascular treatment implants a covered stent into the aorta through a delivery device, isolates the vascular lesions outside the covered stent, and restricts blood flow from the inside of the covered stent, thereby achieving the purpose of protecting the blood vessels.

[0004] However, in the related art, the exposed part of the bare coil of the covered stent is exposed outside the proximal end of the covering membrane of the covered stent, and the proximal end of the covering membrane of the covered stent is flush. The exposed part of the bare coil is used to connect with the anchor of the delivery device to relatively fix the covered stent to the delivery device. The covered stent with such a structure is prone to cause the relative position between the exposed part of the bare coil and the proximal end of the covering membrane of the covered stent to change incompletely and irreversibly when the covered stent is compressed in the delivery device, and then the relative position between the exposed part of the bare coil and the proximal end of the covering membrane of the covered stent cannot fully recover when the delivery device releases the covered stent, so that the proximal end of the covered stent is difficult to better adhere to the blood vessel wall, the adhesion is poor, the occlusion effect of the covered stent is reduced, and even the internal leakage phenomenon is prone to occur, increasing the risk of surgery. SUMMARY

[0005] The present application provides a covered stent and a delivery system, which aims to improve the adhesion and occlusion effect of the covered stent, avoid internal leakage, and at the same time be able to select a smaller diameter sheath tube matched with the covered stent.

[0006] The present application provides a covered stent, comprising:

[0007] a covering body comprising an end section having an open end and a main body section connected to the end section;

[0008] a first coil connected to and fixed relative to the end section;

[0009] A connecting portion is formed in at least one of the end section and the first wave ring, and is used to connect with a delivery device.

[0010] The end surface of the end section comprises a first partial end surface and a second partial end surface connected with each other, and the first partial end surface and the second partial end surface are arranged along the circumferential direction of the covering stent body; compared with the second partial end surface, the first partial end surface protrudes in the direction away from the main body section, and the second partial end surface or the plane where the farthest section of the second partial end surface from the main body section in the axial direction of the covering stent forms an outward convex region between the first partial end surface; at least the end of the connecting portion away from the main body section is arranged in the outward convex region, so as to position the outward convex region on the delivery device.

[0011] In the covering stent of the embodiment of the present application, the connecting portion is arranged in the outward convex region.

[0012] In the covering stent of the embodiment of the present application, the first wave ring comprises a first wave and a second wave, the wave crest of the first wave protrudes more in the direction away from the main body section than the wave crest of the second wave, and the wave crest of the first wave is arranged in the outward convex region.

[0013] In the covering stent of the embodiment of the present application, the wave crest of the second wave is adjacent to or arranged in the second partial end surface.

[0014] In the covering stent of the embodiment of the present application, the connecting portion comprises a connecting line or a connecting band, and the connecting line or the connecting band is connected to at least one of the end section and the first wave ring; or the connecting portion comprises a connecting hole or a connecting seam, and the connecting hole or the connecting seam penetrates the end section.

[0015] In the covering stent of the embodiment of the present application, the connecting portion comprises a connecting film, part of the first wave ring is arranged between the end section and the connecting film, and an insertion opening is arranged between the end section and the connecting film, the insertion opening is used to insert and connect with the delivery device.

[0016] In the covering stent of the embodiment of the present application, the connecting film and the end section are in an integral structure.

[0017] In the covering stent of the embodiment of the present application, the connecting film is made of a material with developing function.

[0018] In the covering stent of the embodiment of the present application, the connecting portion comprises a first end away from the main body section and a second end close to the main body section, and the first end is closer to the longitudinal central axis of the covering stent than the second end.

[0019] In the stent graft of the embodiment of the present application, the number of the first part end faces comprises at least two, and the first part end faces are arranged in a circumferential direction.

[0020] In the stent graft of the embodiment of the present application, when the connecting part comprises a connecting hole or a connecting seam, the stent graft further comprises a second wave, the second wave is connected with the end part, and one of the wave crests of the second wave is arranged adjacent to the connecting hole or the connecting seam.

[0021] In the stent graft of the embodiment of the present application, the first wave comprises a first wave segment and a second wave segment, the radial support strength of the first wave segment is less than that of the second wave segment, the area of the end part on the stent graft is a first area, and the stent graft further comprises:

[0022] a balance structure arranged in the first area, used for increasing the radial support strength of the area in the first area coaxial with the first wave segment.

[0023] The embodiment of the present application further provides a delivery system, comprising:

[0024] a delivery device; and

[0025] The stent graft as any one of the above describes, and the delivery device is used for delivering the stent graft.

[0026] The stent graft and the delivery system provided by the embodiment of the present application have the following advantages. The first wave ring is connected to the end section and fixed relative to the end section, so that the first wave ring and the end section form an integral whole. The connecting part is formed in at least one of the end section and the first wave ring, that is, the connecting part is connected to the integral whole of the end section and the first wave ring. At this time, the connecting part is connected to the delivery device, and the delivery device is connected to the integral whole of the end section and the first wave ring through the connecting part. The connecting part can buffer the force of the delivery device on the relative displacement between the first wave ring and the end section, so that the relative position between the first wave ring and the end section remains unchanged. Therefore, the end section and the first wave ring of the stent graft can better maintain their shapes after the stent graft is released, so that the stent graft can better adhere to the inner wall of the blood vessel, the adhesion of the stent graft is ensured, and the occlusion effect of the stent graft is improved, so that internal leakage is avoided and the risk of surgery is reduced. Meanwhile, on the basis of the above, the outer convex region is arranged, and at least one end of the connecting part away from the main section is arranged in the outer convex region. Compared with the arrangement that the end of the stent graft is flush, when the fixing part on the outer convex region is connected to the anchoring part of the delivery device, the outer convex region is positioned on the anchoring part of the delivery device, so that the outer convex region is in relatively close contact with the anchoring part. The rest of the end section can be arranged in axial misalignment with the outer convex region, so that the radial compression diameter of the part connected to the proximal end anchor of the delivery device is smaller, so that a smaller diameter sheath tube can be selected. In addition, the part positioned on or connected to the proximal end anchor of the delivery device is less, so that unnecessary interference of the stent graft during assembly and release of the anchoring part of the delivery device can be reduced.

[0027] It should be understood that the general description above and the detailed description below are only exemplary and explanatory, and cannot limit the disclosure of the embodiments of the present application. BRIEF DESCRIPTION OF DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0029] Figure 1 is a structural schematic diagram of a delivery system provided by an embodiment of the present application;

[0030] Figure 2 is a structural schematic diagram of a stent graft provided by an embodiment of the present application;

[0031] Figure 3 is a partial structural schematic diagram of a stent graft provided by an embodiment of the present application;

[0032] Figure 4 is a partial structural schematic diagram of a stent graft provided by an embodiment of the present application;

[0033] Figure 5 This is a partial structural schematic diagram of a film-coated stent provided in an embodiment of the present invention;

[0034] Figure 6 This is a partial structural schematic diagram of a film-coated stent provided in an embodiment of the present invention;

[0035] Figure 7 This is a partial structural schematic diagram of a film-coated stent provided in an embodiment of the present invention;

[0036] Figure 8 This is a partial structural schematic diagram of a film-coated stent provided in an embodiment of the present invention;

[0037] Figure 9 This is a schematic diagram showing the position of the connecting part according to an embodiment of the present invention;

[0038] Figure 10 This is a partial structural schematic diagram of a film-coated stent provided in an embodiment of the present invention;

[0039] Figure 11 This is a schematic diagram showing the position of the connecting part according to an embodiment of the present invention;

[0040] Figure 12 This is a schematic diagram of the position of the connecting part provided in an embodiment of the present invention, and an enlarged view of part A therein.

[0041] Figure 13 This is a partial structural schematic diagram of a film-coated stent provided in an embodiment of the present invention;

[0042] Figure 14 This is a partial structural schematic diagram of a film-coated stent provided in an embodiment of the present invention;

[0043] Figure 15 This is a partial structural diagram of the end segment after it has been unfolded according to an embodiment of the present invention;

[0044] Figure 16 This is a partial structural diagram of the end segment after it has been unfolded according to an embodiment of the present invention;

[0045] Figure 17 This is a partial structural diagram of the end segment after it has been unfolded according to an embodiment of the present invention;

[0046] Figure 18 This is a partial structural diagram of the end segment after it has been unfolded according to an embodiment of the present invention;

[0047] Figure 19 This is a partial structural diagram of the end segment after it has been unfolded according to an embodiment of the present invention;

[0048] Figure 20This is a partial structural diagram of the end segment after it has been unfolded according to an embodiment of the present invention;

[0049] Figure 21 This is a partial structural diagram of the end segment after it has been unfolded, according to an embodiment of the present invention.

[0050] Explanation of reference numerals in the attached figures:

[0051] 1000. Conveying system;

[0052] 100, Covered scaffold; 100a, First region;

[0053] 10. Covered body; 11. End segment; 111. Opening end; 1111. Proximal opening end; 1112. Distal opening end; 112. End face; 1121. First part end face; 1122. Second part end face; 11a. Outwardly convex region; 12. Main body segment;

[0054] 20. First wave loop; 21. First wave segment; 21a. First wave; 211. First wave rod; 212. Second wave rod; 213. First wave crest; 22. Second wave segment; 22a. Second wave; 221. Third wave rod; 222. Fourth wave rod; 223. Second wave crest; 2011. The portion of the first wave loop 20 that is at least partially exposed outside the coating body 10 along the axial direction;

[0055] 30. Supporting framework;

[0056] 40. Connecting part; 41. Connecting line; 42. Connecting strap; 43. Connecting hole; 44. Connecting seam; 441. Open end of the connecting seam; 45. Connecting membrane; 450. Insertion port; 451. Suture thread;

[0057] 50. Balanced structure; 51. Second wave loop; 511. Third wave; 5111. Fifth wave lever; 5112. Sixth wave lever; 5113. Third wave crest; 512. Fourth wave; 5121. Seventh wave lever; 5122. Eighth wave lever; 5123. Fourth wave crest; 52. Third wave loop; 53. Closed structure; 54. Fourth wave loop;

[0058] 61. First intersection point; 62. Second intersection point;

[0059] 200. Conveyor; 201. Sheath; 202. Sheath core; 203. Anchoring component. Detailed Implementation

[0060] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0061] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of the stated features. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0062] It should also be understood that the terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the invention. As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context clearly indicates otherwise.

[0063] It should also be further understood that the term "and / or" as used in this specification and the appended claims refers to any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0064] The following detailed description of some embodiments of the present invention is provided in conjunction with the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0065] For ease of description, the terms "proximal" and "distal" are used here as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end from which blood flows out, and "proximal" refers to the end from which blood flows in. For example, after a covered stent is implanted into the lumen, blood flows from the proximal end of the covered stent toward the distal end. "Axial" refers to its length direction, or the direction in which the interventional device is advanced and de-escalated. "Radial" refers to the direction perpendicular to the "axial" direction.

[0066] Taking blood vessels as an example to illustrate the lumen, the blood vessels may include, but are not limited to, at least one of the following: ascending aorta, aortic arch, descending aorta, thoracic aorta, abdominal aorta, veins, etc. Those skilled in the art should understand that the use of blood vessels as an example is merely illustrative and not intended to limit the invention. The solutions of this invention are applicable to various human or animal lumens. Human lumens may include, for example, the digestive tract lumen or blood vessels. Various improvements and modifications based on the teachings of this invention are within the protection scope of this invention.

[0067] In this embodiment of the invention, the "wave loop" is a closed or non-closed waveform ring structure, also referred to as a waveform ring structure. It can be disposed on the inner and / or outer wall of the covered body of the covered stent. The wave loop is connected to the covered body by at least one of the following connection methods: suturing, bonding, heat fusion, etc. Exemplarily, at least a portion of the wave loop can be made of a material with good tensile and resilience properties and good biocompatibility. For example, the material includes at least one of the following: known materials used in implantable medical devices, various biocompatible materials, such as alloys of two or more single metals selected from cobalt, chromium, nickel, titanium, magnesium, and iron, stainless steel or nickel-titanium-tantalum alloys, or other biocompatible elastic materials. The wave loop has radial expansion capability, can achieve radial contraction under external force, and after the external force is removed, it self-expands or recovers to its initial shape and maintains its initial shape through mechanical expansion (e.g., balloon expansion). Thus, after implantation into the lumen, it can adhere tightly to the inner wall of the lumen through its radial support force. The waveform of a wave loop is unrestricted and may include at least one of the following: Z-shaped wave, M-shaped wave, V-shaped wave, sine wave, etc. A wave loop comprises multiple crests (also known as near-end vertices), multiple troughs (also known as far-end vertices), and wave rods connecting adjacent crests and troughs. A single vertex (near-end or far-end) and the two wave rods connected to that vertex form a wave.

[0068] Understandably, in the embodiments of the present invention, "wave number" refers to the number of wave crests or wave troughs. "Wave height" refers to the vertical distance between a wave crest and the adjacent lowest wave trough. "Wave angle" refers to the angle between two adjacent wave rods connecting the same vertex.

[0069] Understandably, radial support force (in N) can be measured using a radial support force tester, such as the Machine Solution Inc. (MSI) RX550-100 radial support force tester. Taking the first wavering as an example, the first wavering is placed inside the radial clamp of the tester. During the test, the radial clamp is kept in place to uniformly compress the first wavering radially until the first wavering is compressed to 20% of its original diameter, and the radial support force of the first wavering at this point is measured.

[0070] The radial support force of the first wave of the first test ring is less than that of the second wave of the first test ring, which can be measured by the following method: Construct a first test ring composed of multiple first waves, with the same diameter as the first test ring; construct a second test ring composed of multiple second waves, with the same diameter as the first test ring; test the radial support forces of the first and second test rings respectively, and find that the radial support force of the first test ring is less than that of the second test ring. Since both the first and second waves are on the first test ring, the maximum axial length of the first test ring is the same value, thus it can be calculated that the radial support force of the first wave of the first test ring is less than that of the second wave of the first test ring.

[0071] The radial support strength (unit: Pa) mentioned in this embodiment of the invention can be calculated by the following formula: Radial support strength = Radial support force ÷ Maximum axial length of the measured position. It is understood that when multiple corrugations are axially arranged at the measured position, the closer the corrugations are to each other axially, the greater the radial support strength.

[0072] It should be noted that A equals B means that A equals B within the range of assembly and / or installation errors, or that A is approximately equal to B.

[0073] Please refer to Figure 1 This invention provides a delivery system 1000, including a covered stent 100 and a delivery device 200. The delivery device 200 is used to deliver the covered stent 100 to the location of the vascular lesion, thereby isolating the vascular lesion outside the covered stent 100 and thus achieving the purpose of protecting the blood vessel.

[0074] Please see Figure 1 In some embodiments, the delivery device 200 includes a sheath core 201 and a sheath tube 202, with the sheath core 201 passing through the sheath tube 202, which is capable of accommodating and delivering the covered stent 100. When it is necessary to deliver the covered stent 100 to the vascular lesion site, the covered stent 100 can be first connected to the anchor 203 of the delivery device 200, and the covered stent 100 can be compressed and loaded between the sheath tube 202 and the sheath core 201 to facilitate the delivery of the covered stent 100.

[0075] Understandably, the covered stent 100 can be radially compressed and loaded into the sheath 202 of the delivery device 200. After the covered stent 100 is implanted into the lesion site through the delivery device 200, the covered stent 100 can isolate blood flow from the lesion site, eliminate the influence of blood pressure on the lesion site, and achieve the purpose of cure.

[0076] Please see Figure 2In some embodiments, the covered stent 100 includes a covered body 10 and a first wave coil 20. The covered body 10 includes an end segment 11 having an open end 111. The first wave coil 20 is connected to and fixed relative to the end segment 11. Understandably, the covered body 10 includes a hollow tubular structure, and the hollow cavity of the covered body 10 forms a channel for blood flow.

[0077] Please see Figure 2 In some embodiments, the coating body 10 has at least one proximal opening end 1111 and one distal opening end 1112. The first corrugated coil 20 may be disposed at the end segment 11 where the proximal opening end 1111 is located, or at the end segment 11 where the distal opening end 1112 is located, or simultaneously at both ends of the coating body 10, depending on actual needs. For example, the first corrugated coil 20 is disposed at the proximal opening end 1111 of the coating body 10.

[0078] Please see Figure 2 In some embodiments, the covered body 10 further includes a main body segment 12, and the covered stent 100 further includes a supporting frame 30, with an end segment 11 connected to the main body segment 12; the supporting frame 30 is connected to the main body segment 12 and is used to support the main body segment 12. The end segment 11 is located at the proximal end of the main body segment 12, or the end segment 11 is located at the distal end of the main body segment 12. The supporting frame 30 has radial expansion capability, which can achieve radial contraction under the action of external force, and recover to its initial shape and maintain its initial shape after the external force is removed, thereby allowing it to adhere tightly to the inner wall of the blood vessel through its radial support force after implantation. Exemplarily, the main body segment 12 includes a tubular main covered body, and the supporting frame 30 includes at least one supporting coil.

[0079] Exemplarily, both the main body membrane and the end membrane can be single-layer or multi-layer structures, without limitation. Both the main body membrane and the end membrane can be made of at least one of the following materials: polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or other polymeric materials with good biocompatibility. The main body membrane can be fixed to the inner and / or outer surface of the supporting skeleton 30 by means of suturing, bonding, heat fusion, etc., to reconstruct fluid channels and isolate diseased areas of blood vessels.

[0080] For example, the axial region of end segment 11 is as follows Figure 2 As shown in A1, the axial region of the main body segment 12 is as follows: Figure 2 As shown in B in the diagram.

[0081] In some embodiments, the end segment 11 includes a tubular end cover, and the open end 111 of the end segment 11 may be formed by the edge or end face 112 of the end cover (see [reference]). Figure 3 The end segment 11 is formed by enclosure. Exemplarily, an end support assembly is provided on the end segment 11, and the end film can be fixed to the inner and / or outer surface of the end support assembly by means of sewing, bonding, heat fusion, etc. The end support assembly includes a first corrugated coil 20 connected to the end segment 11. In other embodiments, the end support assembly further includes other corrugated coils connected to the end segment 11 to further increase the radial anchoring force of the film body 10 and further improve the stability of the film support 100 during use.

[0082] In some embodiments, the end segment 11 is switchable between a first state and a second state. The radial dimension of the end segment 11 in the first state is smaller than its radial dimension in the second state. The second state can be a naturally unfolded state, i.e., a naturally extended state without external human force; or it can be a state that has been radially compressed to a certain extent and is not yet fully unfolded. In either state, its radial dimension is larger than that in the first state. Please refer to [link / reference]. Figure 3 When the end segment 11 is in the second state, the first wave ring 20 is located inside the end segment 11, and at this time the axial region A2 of the first wave ring 20 is located inside the axial region A1 where the end segment 11 is located.

[0083] Please see Figure 3 and Figure 4 In some embodiments, the coating support 100 further includes a connecting portion 40, which is formed in at least one of the end section 11 and the first corrugated coil 20, and is used to connect with the conveyor 200. The end face 112 of the end section 11 includes a first part end face 1121 and a second part end face 1122 connected to each other, the first part end face 1121 and the second part end face 1122 being arranged circumferentially along the coating body 10; compared to the second part end face 1122, the first part end face 1121 protrudes away from the main body section 12, i.e., protrudes outwards, and an outwardly protruding region 11a is formed between the surface of the second part end face 1122 and the first part end face 1121. At least one end of the connecting portion 40 away from the main body section 12 is disposed within the outwardly protruding region 11a, for driving the outwardly protruding region 11a to be positioned on the conveyor 200. In this case, the surface of the second part end face 1122 is a plane.

[0084] In this embodiment, since the first wave coil 20 is connected to and relatively fixed to the end segment 11, the first wave coil 20 and the end segment 11 form a whole. The connecting part 40 is formed in at least one of the end segment 11 and the first wave coil 20, that is, the connecting part 40 is connected to the whole of the end segment 11 and the first wave coil 20. At this time, the connecting part 40 is connected to the conveyor 200. The conveyor 200 is connected to the whole of the end segment 11 and the first wave coil 20 through the connecting part 40, which can buffer the conveying. The force exerted by the delivery device 200 on the relative displacement between the first wave coil 20 and the end segment 11 ensures that the relative position between the first wave coil 20 and the end segment 11 remains unchanged. This ensures that the end segment 11 and the first wave coil 20 of the covered stent 100 can maintain their shape well after the covered stent 100 is released, allowing the covered stent 100 to better adhere to the inner wall of the blood vessel, ensuring the wall apposition of the covered stent 100, thereby improving the occlusion effect of the covered stent 100, avoiding endoleak, and reducing surgical risks.

[0085] Meanwhile, while ensuring wall adhesion, the film-coated support 100 of this embodiment can be compressed in the loaded state and connected and fixed to the anchor 203 of the conveyor 200 through the connecting part 40. The connecting part 40 is connected to the anchor 203, and at least the end of the connecting part 40 that is away from the main body section 12 is provided in the convex region 11a, thereby driving the convex region 11a to be positioned on the anchor 203, forming a relatively tight contact. Compared to the planar end face 112 of the covered stent 100, the convex region 11a is the area axially enclosed by the second part of the end face 1122 and the first part of the end face 1121. The remaining part of the covered stent 100 can be at least partially offset from the connecting part 40 or the convex region 11a along the axial direction of the covered stent 100, thereby making the radial compression diameter of the part of the covered stent 100 connected to the anchor 203 smaller. This facilitates the installation of the covered stent 100 into the smaller diameter sheath 201, which in turn facilitates the delivery device 200 to deliver the covered stent 100 to the lesion site. In addition, the smaller portion of the covered stent 100 connected to the anchor 203 reduces unnecessary interference between the covered stent 100 and the anchor 203 of the delivery device 200 during assembly and / or release, improves assembly efficiency and / or release efficiency, and reduces damage to the covered stent 100 and / or the delivery device 200.

[0086] Please see Figure 3In some embodiments, the first corrugated ring 20 is located within the end section 11. In this case, the axial region A2 of the first corrugated ring 20 is located within the axial region A1 of the end section 11, meaning that the end section 11 can completely cover the first corrugated ring 20. The first corrugated ring 20 does not have any bare support portion exposed axially outside the coating body 10. This prevents the exposed portion of the first corrugated ring 20 from being easily pulled by the conveyor 200, causing incompletely reversible deformation when the coating support 100 is compressed. This ensures that the first corrugated ring 20 can recover and maintain its shape after release, thereby ensuring that the end section 11 and the coating support 100 can maintain their shape well after release, ensuring that the coating support 100 has good wall adhesion, improving the sealing effect of the coating support 100, and avoiding internal leakage. For example, at least a portion of the peaks of the first wave 20 are flush with the end face 112 of the end segment 11; or, the peaks of the first wave 20 are positioned adjacent to the end face 112 of the end segment 11, and the axial region A2 of the first wave 20 is located within the axial region A1 of the end segment 11, so that the open end 111 of the end segment 11 can better maintain its shape and better conform to the inner wall of the blood vessel.

[0087] In some embodiments, the surface containing the second portion end face 1122 is a plane; or, the second portion end face 1122 is a concave curved surface or a convex curved surface. For example, if the second portion end face 1122 is a plane, the surface containing the second portion end face 1122 is as follows: Figure 4 As shown by ω, the surface ω containing the second part end face 1122 and the first part end face 1121 (marked with a dashed line) enclose and form an outwardly convex region 11a. See also Figure 5 If the second end face 1122 is concave relative to the first end face 1121, that is, the second end face 1122 is a concave curved surface, then the surface ρ of the concave curved surface that is furthest from the main body segment 12 in the direction perpendicular to the axial direction of the film-coated support is selected and compared with the first end face 1121 (e.g., Figure 5 The area marked with a dashed line (in the center) encloses and forms a convex region 11a. See also... Figure 6 The second part end face 1122 is a convex curved surface. The surface ρ, located at the section furthest from the main body segment 12 in the direction perpendicular to the axial direction of the film-coated support, is selected and intersected with the first part end face 1121 (e.g., ...). Figure 6 The area marked with a dashed line in the middle encloses and forms an outwardly convex region 11a.

[0088] In some embodiments, the number of the first end face 1121 and the second end face 1122 can be designed according to actual needs, such as one, two, three, or more. See also Figure 3In some embodiments, the number of first partial end faces 1121 includes at least two, and multiple first partial end faces 1121 are arranged at intervals along the circumference of the film-coating bracket 100. Each first partial end face 1121 is provided with at least one connecting portion 40 to improve the connection reliability between the film-coating bracket 100 and the conveyor 200. It is understood that a second partial end face 1122 connects two adjacent first partial end faces 1121. Exemplarily, multiple first partial end faces 1121 are arranged at equal intervals along the circumference to make the radial support performance of the end segment 11 more uniform, thus ensuring good wall adhesion of the film-coating bracket 100.

[0089] Understandably, the connecting portion 40 is formed on at least one of the end section 11 and the first wave coil 20, including: the connecting portion 40 is formed on the end section 11 or the first wave coil 20; the connecting portion 40 is formed on the end section 11 and the first wave coil 20.

[0090] In some embodiments, the connecting portion 40 is used to hook and engage with the anchor 203 of the conveyor 200, and the assembly and release of the connecting portion 40 and the anchor 203 are simple and quick. Exemplarily, one of the anchor 203 and the connecting portion 40 may include a hook, and the other includes a hollow structure or a hole structure that engages with the hook.

[0091] Please see Figure 4 or Figure 7In some embodiments, the connecting portion 40 includes a connecting line 41 or a connecting band 42, which connects to at least one of the end segment 11 and the first wave coil 20. With this structure, the force applied by the delivery device 200 to the connecting portion 40 can be more evenly distributed across the first wave coil 20 and the end segment 11 as a whole, thereby ensuring that the end segment 11 and the covered stent 100 maintain their shape well after release, allowing the covered stent 100 to better adhere to the vascular wall and ensuring the wall apposition of the covered stent 100. For example, the connecting line 41 or the connecting band 42 is at least connected to the first wave coil 20, and the force applied by the delivery device 200 to the connecting portion 40 can be more evenly distributed at various connection points between the first wave coil 20 and the end segment 11, thereby ensuring that the end segment 11 of the covered stent 100 and the covered stent 100 maintain their shape well after release, improving the wall apposition of the covered stent 100. For example, the connecting line 41 is located at the crest of the first wave 20. This ensures good adhesion of the covered stent 100 to the vessel wall while fully utilizing the space occupied by the first wave 20 and the first end face 1121, resulting in a compact structure and small footprint for the covered stent 100. The connecting line 41 or connecting strip 42 can be located on the inner wall or outer wall of the end segment 11. For example, if the connecting line 41 or connecting strip 42 is located on the inner wall of the end segment 11, it can reduce damage to the vessel wall caused by the connecting portion 40 when the delivery device 200 implants the covered stent 100 into the blood vessel, avoiding significant irritation or damage. The materials of the connecting line 41 or connecting strip 42 include, but are not limited to, metallic materials, polymeric materials, or composite materials of metal and polymer.

[0092] In this embodiment, the connecting line 41 or connecting band 42 is located within the convex region 11a. The location of the connecting line 41 or connecting band 42 within the convex region 11a ensures that after the connecting line 41 or connecting band 42 hooks onto the anchor 203, the convex region 11a can be more accurately positioned onto the anchor 203, reducing or avoiding contact between the non-convex region of the covered bracket 100 and the anchor 203, thus allowing for the selection of a sheath with a smaller inner diameter.

[0093] For example, the connecting line 41 may include any suitable linear or filamentous structure. The connecting strip 42 may include a strip structure or a band structure, such as a strip-shaped coating. One end of the connecting strip 42 is connected to the first corrugated coil 20 and / or the end segment 11, and the other end of the connecting strip 42 is connected to the first corrugated coil 20 and / or the end segment 11. The middle portion of the connecting strip 42 is used for hooking onto the anchor 203 of the conveyor 200.

[0094] Please see Figure 8In some embodiments, the connecting portion 40 includes a connecting hole 43 through which the anchor 203 of the conveyor 200 is fixed to the film-coating bracket 100. Exemplarily, the connecting hole 43 extends through the end segment 11. In this embodiment, the connecting hole 43 can be circular, square, or irregular in shape.

[0095] Understandably, the end of the connecting hole 43 that is at least away from the main body segment 12 is located within the protruding area 11a, including: Case 1, the connecting hole 43 is located within the protruding area 11a; Case 2, the end of the connecting hole 43 that is away from the main body segment 12 is located within the protruding area 11a, and the end that is close to the main body segment 12 is located in other areas of the end segment 11 besides the protruding area 11a.

[0096] Since the anchoring part 203 is hooked at the end of the connecting hole 43 that is away from the main body section 12, the end of the connecting hole 43 that is close to the main body section 12 can be set anywhere in the end section 11.

[0097] Please see Figure 2 , Figure 8 and Figure 9 In some embodiments, the connecting portion 40 includes a first end C1 away from the main body segment 12 and a second end C2 close to the main body segment 12. The first end C1 is closer to the axis m of the covering bracket 100 than the second end C2, so that the connecting portion 40 has a certain tilt angle, making it easier for the anchor 203 of the conveyor 200 to be released and disengaged from the connecting portion 40. In other embodiments, the first end C1 and the second end C2 of the connecting portion 40 may be at the same distance from the axis m of the covering bracket 100; or, the first end C1 of the connecting portion 40 may be further away from the axis m of the covering bracket 100 than the second end C2.

[0098] Please see Figure 8 and Figure 9 For example, the connecting portion 40 includes a connecting hole 43. The wall of the connecting hole 43 has a first end C1 (i.e., the proximal end of the wall of the connecting hole 43) and a second end C2 (i.e., the distal end of the wall of the connecting hole 43). The angle α between the straight line containing the first end C1 and the second end C2 of the connecting hole 43 and the axis m of the covering bracket 100 is an acute angle. The first end C1 of the wall of the connecting hole 43 is closer to the axis m of the covering bracket 100 than the second end C2 of the wall of the connecting hole 43, so that the connecting hole 43 has a certain tilt angle, making it easier for the anchor 203 of the conveyor 200 to be released and disengaged from the connecting hole 43. In other embodiments, the angle α between the straight line containing the first end C1 and the second end C2 of the connecting hole 43 and the axis m of the covering bracket 100 may not be an acute angle. For example, the straight line containing the first end C1 and the second end C2 of the connecting hole 43 may be parallel to the axis m of the covering bracket 100.

[0099] exist Figure 10 In this embodiment, for example, the connecting portion 40 includes a connecting seam 44 formed in the end section 11. Specifically, the connecting seam 44 is cut out on the end section 11 and extends through the end section 11. The anchoring member 203 of the conveyor 200 is fixed to the film-coated support 100 by passing through the connecting seam 44. In this embodiment, the shape of the connecting seam 44 can be straight (e.g., ...). Figure 10 (c) shown), U-shaped (as shown in) Figure 10 (a) shown), V-shape (as shown in) Figure 10 (b) shown), W-shaped, etc. Among them, U-shaped, V-shaped, W-shaped, etc. belong to the connecting seams 44 with an open end 441. The open end 441 of the connecting seam 44 is close to the main body section 12, so that the anchoring member 203 of the conveyor 200 can hook from the end of the connecting seam 44 away from the main body section 12. It can be understood that since the connecting seam 44 with an open end 441 can be opened to form a larger opening, the connecting seam 44 with an open end 441 makes it easier for the anchoring member 203 of the conveyor 200 to extend into the connecting seam 44 for hooking than the straight connecting seam 44.

[0100] Combination Figure 11 and Figure 12 For example, the connecting portion includes a connecting membrane 45, and a portion of the first corrugated coil 20 is disposed between the end section 11 and the connecting membrane 45. An insertion port 450 is provided between the end section 11 and the connecting membrane 45 for inserting the anchor 203 of the conveyor 200 to achieve connection. In this embodiment, the connecting membrane 45 and the end section 11 are an integral structure, meaning the connecting membrane 45 extends from the covering body 10. Specifically, the covering body 10 extends towards the open end 111, folds inward at the end face 112, and then extends away from the open end 111 to form the connecting membrane 45. The connecting membrane 45 is sewn and fixed to both sides of the end section 11 by a stitch 451, and the insertion port 450 is formed at the position of the connecting membrane 45 away from the open end 111. In another embodiment, the connecting membrane 45 and the end section 11 are not an integral structure; the connecting membrane 45 is a separate piece of membrane. The connecting membrane 45 can be connected to at least one of the end section 11 or the first corrugated coil 20 by sewing or adhesive. In one embodiment, the connecting film 45 may be made of a material with developing function, which can be used to indicate the position of the opening end of the coating support 100. Specifically, a developing element may be connected to the connecting film 45, or a developing solution may be impregnated on the connecting film 45.

[0101] Please see Figure 13In some embodiments, the coating support 100 further includes a second corrugated coil 51 connected to the end segment 11. The connecting portion 40 includes a connecting hole 43, and one crest of the second corrugated coil 51 is disposed adjacent to the connecting hole 43. Thus, during the assembly and release of the coating support 100, the second corrugated coil 51 can better support the coating body 10 around the connecting hole 43, avoiding a situation where the connecting portion 40 or the end segment 11 cannot be released from the anchor 203 of the conveyor 200 due to deformation of the connecting hole 43. It is understood that one crest of the first corrugated coil 20 may also be disposed adjacent to the connecting seam 44.

[0102] Please see Figure 13 In some embodiments, one of the crests of the first corrugated coil 20 is disposed adjacent to the connecting hole 43. Along the axial direction of the coating support 100, the connecting hole 43 is located between one of the crests of the first corrugated coil 20 and one of the crests of the second corrugated coil 51. Thus, during the assembly and release of the coating support 100, both the first corrugated coil 20 and the second corrugated coil 51 can effectively support the coating body 10 around the connecting hole 43, effectively preventing the connecting portion 40 or the end segment 11 from being unable to release from the anchor 203 of the conveyor 200 due to deformation of the connecting hole 43. For example, one crest of the first corrugated coil 20, the connecting hole 43, and one crest of the second corrugated coil 51 are sequentially arranged along the axial direction of the coating support 100, with one crest of the first corrugated coil 20 being closer to the end face 112 of the end segment 11 than one crest of the second corrugated coil 51. In other embodiments, the second wave loop 51 may intersect with or not intersect with the first wave loop 20, and the crest of the second wave loop 51 has a certain circumferential distance from the connecting hole 43.

[0103] In some embodiments, the first wave coil 20 includes a wave-shaped annular structure formed by a first support wire. The first wave coil 20 is elastically deformable and may be partially or entirely made of an elastic material. For example, the first wave coil 20 may be made of a material with good tensile and resilience properties and good biocompatibility, such as nickel-titanium or stainless steel. Because the first wave coil 20 has good tensile and resilience properties, it possesses its own elastic force to recover from deformation. The elastically deformable nature of the first wave coil 20 increases the radial anchoring force of the coating body 10 and improves the stability of the coating support 100 during use. In other embodiments, the first wave coil 20 may also be made of a non-elastic material. For example, in a first wave coil 20 made of a non-elastic material, adjacent wave rods are rotatably connected by a pivot. In this case, the first wave coil 20 itself does not possess elasticity; its deformation is driven by the self-expanding coating body 10 and / or other wave coils of the coating support 100.

[0104] Please see Figure 14In some embodiments, the first wave loop 20 includes a first waveform segment 21. In some embodiments, the first waveform segment 21 includes at least one first wave 21a. Exemplarily, the first waveform segment 21 includes a first wave rod 211 and a second wave rod 212, with adjacent first wave rods 211 and second wave rods 212 connected to the same first wave crest 213 to form the first wave 21a.

[0105] For example, the position of the first waveform segment 21 or the first wave 21a is coaxially arranged with the position of the first part end face 1121, so that the first waveform segment 21 or the first wave 21a can support the first part end face 1121.

[0106] Please see Figure 14 In some embodiments, the first wave loop 20 further includes a second wave segment 22. Exemplarily, the first wave segment 21 is connected to the second wave segment 22. In some embodiments, the second wave segment 22 includes at least one second wave 22a. Exemplarily, the first wave loop 20 includes a third wave rod 221 and a fourth wave rod 222, with adjacent third wave rods 221 and fourth wave rods 222 connected to the same second wave peak 223 to form the second wave 22a.

[0107] For example, the position of the second waveform segment 22 or the second wave 22a is coaxially arranged with the position of the second part end face 1122, so that the second waveform segment 22 or the second wave 22a can support the second part end face 1122.

[0108] For example, the first end face 1121, the crest of the first wave 21a, and at least a portion of the connecting portion 40 are arranged sequentially along the axial direction of the film-coated support 100, resulting in a compact structure and good wall adhesion of the end section 11. In other embodiments, the first wave ring 20 may also intersect with the end face 112 of the end section 11.

[0109] Please see Figure 14In some embodiments, the crest of the first wave 21a is located in the convex region 11a, so that the first wave 21a can effectively support the convex region 11a. Exemplarily, the first wave 21a is located inside the end segment 11, preventing the first wave 21a from being at least partially exposed outside the end segment 11. Furthermore, the first wave 21a is connected to the end segment 11 and relatively fixed to it, ensuring that the first wave 21a never detaches from the end segment 11. This avoids the problem of the first wave 21a being easily pulled by the conveyor 200, leading to incompletely reversible deformation when the covering support 100 is compressed. This ensures that the first wave 21a and the end segment 11 can recover after release. This design maintains its shape, ensuring good adhesion of the covered stent 100 to the vessel wall, improving its occlusion effect, and preventing internal leakage. Compared to the first wave 21a, which is at least partially exposed axially outside the end section 11, in this embodiment, the axial region of the first wave 21a is located within the axial region of the end section 11. This reduces the likelihood of collisions or friction between the first wave ring 20 and the delivery device 200, thereby reducing unnecessary interference between the covered stent 100 and the delivery device 200 during assembly and / or release. For example, the crest of the first wave 21a is adjacent to the convex apex of the first part end face 1121, or the crest of the first wave 21a is located on the first part end face 1121, effectively supporting the convex region 11a of the covered body 10 and the end of the covered stent 100, resulting in better adhesion of the covered stent 100 and reducing the risk of blood leakage after implantation into the blood vessel.

[0110] For example, the second wave 22a is located inside the end section 11, avoiding the second wave 22a being at least partially exposed outside the end section 11. This prevents the exposed part of the second wave 22a from being easily pulled by the conveyor 200, which could cause the exposed part of the second wave 22a to undergo incompletely reversible deformation when the covered support 100 is compressed. This ensures that the second wave 22a can recover and maintain its shape after release, thereby ensuring that the end section 11 and the covered support 100 can maintain their shape well after release, ensuring that the covered support 100 has good wall adhesion, improving the sealing effect of the covered support 100, and avoiding internal leakage. For example, the peak of the second wave 22a is set close to the end face 1122 of the second part, or the peak of the second wave 22a is located at the end face 1122 of the second part, so that the second wave 22a can effectively support the end face 1122 of the second part of the covered body 10 and the end of the covered stent 100, so that the covered stent 100 has better wall adhesion and is less prone to leakage after the covered stent 100 is implanted into the blood vessel.

[0111] Understandably, the wire diameter, wave height, wave number, and wave angle of the first wave 20 can all be set according to actual needs. For example, the wire diameter of the first wave 20 can range from 0.3mm to 0.45mm, such as 0.3mm, 0.4mm, 0.45mm, or any other suitable value between 0.3mm and 0.45mm. The wave height of the first wave 21a and / or the second wave 22a can range from 1mm to 15mm, such as 1mm, 5mm, 15mm, or any other suitable value between 1mm and 15mm. The number of the first wave 21a and / or the second wave 22a can range from 3 to 30, such as 3, 6, 10, 20, 30, or any other suitable value between 3 and 30. The more waves in the wave 20, the greater the radial support force on the end of the coated support 100, which can effectively improve the wall adhesion effect at the end of the coated support 100.

[0112] Please see Figure 14 In some embodiments, the first wave loop 20 includes a first wave segment 21 and a second wave segment 22, the radial support strength of the first wave segment 21 is less than the radial support strength of the second wave segment 22, and the region where the end segment 11 on the covered support 100 is located is the first region 100a. It can be understood that the first region 100a includes the end segment 11 and the wave loop disposed on the end segment 11.

[0113] Understandably, when the covered stent 100 is released from the delivery device 200, the first wave coil 20 will rebound under its own elastic force, causing the first region 100a to contact the inner wall of the blood vessel during the rebound process. However, because the radial support strength of the first wave segment 21 is less than that of the second wave segment 22, the second wave segment 22 rebounds faster than the first wave segment 21. This uneven circumferential release of the first region 100a results in uneven circumferential force exerted by the first region 100a on the inner wall of the blood vessel, easily leading to concentrated force inside the vessel. This can easily cause impact or damage to the blood vessel during release, causing patient discomfort or even vasospasm. Furthermore, the uneven circumferential release of the first region 100a also affects the shape of the covered stent 100 after compression and release, resulting in insufficient adhesion of the first region 100a to the vessel wall, thus easily causing endoleak and increasing surgical risks. For this reason, please refer to [link to relevant documentation]. Figure 15 In some embodiments, the covered support 100 further includes a balancing structure 50 disposed within the first region 100a. The balancing structure 50 is used to increase the radial support strength of the region in the first region 100a that is coaxial with the first waveform segment 21. In this embodiment, the balancing structure 50 is located on the surface of the end segment 11 or between the inner and outer surfaces.

[0114] The covered stent 100 of the above embodiment includes a balancing structure 50 connected to the end segment 11. The balancing structure 50 is used to increase the radial support strength of the region in the first region 100a that is coaxial with the first waveform segment 21. The balancing structure 50 can balance the radial support strength of the region in the first region 100a that is coaxial with the first waveform segment 21 and the region in the first region 100a that is coaxial with the second waveform segment 22, thereby reducing the difference between the release speed of the region in the first region 100a that is coaxial with the first waveform segment 21 and the region in the first region 100a that is coaxial with the second waveform segment 22. This makes the release of the first region 100a and the covered stent 100 more uniform in the circumferential direction, and makes the force exerted by the first region 100a and the covered stent 100 on the circumferential wall of the blood vessel more uniform, reducing the phenomenon of concentrated force on the inner wall of the blood vessel, and reducing the stimulation and damage to the blood vessel during the release process. In addition, the uniform release in the circumferential direction in the first region 100a allows the end segment 11 or the first region 100a to maintain its shape well after the covered stent 100 is compressed and released, resulting in good adhesion of the first region 100a and the covered stent 100 to the wall, avoiding endoleak and reducing surgical risks.

[0115] In some embodiments, the radial support strength of the first wave 21a is less than the radial support strength of the second wave 22a. For example, the wave height of the first wave 21a is greater than the wave height of the second wave 22a, and the wave angle of the first wave 21a is equal to the wave angle of the second wave 22a, such that the radial support strength of the first wave 21a is less than that of the second wave 22a. For example, when the axial region of the first wave ring 20 is located within the axial region of the end segment 11, the greater wave height of the first wave 21a and the equality of the wave angle of the first wave 21a with the second wave 22a enable the first wave 21a to better support the first partial end face 1121, and result in the radial support strength of the first wave 21a being less than that of the second wave 22a. When the first wave 20 is at least partially exposed outside the axial region of the end section 11 along the axial direction, the wave height of the first wave 21a is greater than the wave height of the second wave 22a, and the wave angle of the first wave 21a is equal to the wave angle of the second wave 22a. This allows the first wave 21a to be more easily and conveniently connected to the anchor 203 of the conveyor 200, and makes the radial support strength of the first wave 21a less than the radial support strength of the second wave 22a. In other embodiments, the wave height of the first wave 21a may also be less than or equal to the wave height of the second wave 22a. The wave angle of the first wave 21a may also be greater than or less than the wave angle of the second wave 22a.

[0116] In other embodiments, the radial support strength of the first waveform segment 21 is greater than or equal to the radial support strength of the second waveform segment 22. The radial support strength of the first wave 21a is greater than or equal to the radial support strength of the second wave 22a.

[0117] Please see Figure 15 and Figure 16 In some embodiments, the balancing structure 50 includes a second wave coil 51 connected to the end segment 11. The second wave coil 51 increases the radial support strength of the region in the first region 100a coaxial with the first wave segment 21, thereby balancing the radial support strength of the regions in the first region 100a coaxial with the first wave segment 21 and the regions in the first region 100a coaxial with the second wave segment 22. This reduces the difference in release speed between the regions in the first region 100a coaxial with the first wave segment 21 and the regions in the first region 100a coaxial with the second wave segment 22, resulting in more uniform circumferential release of the first region 100a and the covered stent 100. Furthermore, the second wave coil 51 also strengthens the support of the end segment 11, ensuring that the first region 100a adheres well to the wall after release, preventing the first region 100a from developing a beak-like shape that could lead to bleeding. In other embodiments, the balancing structure 50 is not necessarily a wave coil structure; it can be a separate element, such as a mesh or block made of metal or plastic.

[0118] In some embodiments, the balancing structure 50 is located within the end section 11 so that the balancing structure 50 can effectively increase the radial support strength of the region in the first region 100a that is coaxial with the first wave segment 21. Exemplarily, the first wave coil 20 and the balancing structure 50 are spaced apart along the axial direction of the coating support 100 to avoid the balancing structure 50 interfering with the connection and release of the first wave coil 20 with the conveyor 200.

[0119] In some implementations, the second wave loop 51 may also intersect with the first wave loop 20, such as... Figure 14 As shown; and / or, the second wave loop 51 is located within the end segment 11. In some embodiments, please refer to... Figure 14 and Figure 16 The proximal end of the second wave coil 51 or the proximal end of the balancing structure 50 may be located near the end face 112 of the end segment 11, specifically near the second part of the end face 1122, so that the second wave coil 51 or at least part of the balancing structure 50 can support the end face 112 of the end segment 11 to a certain extent, so that the end face 112 of the end segment 11 can maintain a good shape after the covered stent 100 is compressed and released, thereby making the covered stent 100 have better wall adhesion and less prone to blood leakage.

[0120] Please see Figure 17In some embodiments, at least two of the end face 112 of the end segment 11, the first corrugated coil 20, and the second corrugated coil 51 are spaced apart in the axial direction. Exemplarily, the end face 112 of the end segment 11, the first corrugated coil 20, and the second corrugated coil 51 are sequentially spaced apart along the axial direction of the coating support 100, thereby facilitating the processing of the coating support 100.

[0121] In some embodiments, the axial region of the second wave 51 at least partially overlaps with the axial region of the first wave 20, reducing the axial distance between the second wave 51 and the first wave 20. This increases the radial support strength at the proximal end of the covered stent 100, thereby enhancing the radial support force of the first region 100a. This increases the anchorage of the proximal end of the covered stent 100 in the blood vessel, making it less prone to displacement at the proximal end of the covered stent 100, improving the sealing performance of the covered stent 100, and enabling the covered stent 100 to have a more compact structure.

[0122] Please see Figure 17 In some embodiments, the second wave loop 51 is connected to the end segment 11 and is located within the end segment 11. For example, at least a portion of the crests of the second wave loop 51 are flush with the end face 112 of the end segment 11; or, the crests of the second wave loop 51 are spaced apart from the end face 112 of the end segment 11 by a certain distance, and the end face 112 of the end segment 11 is located near the crest of the second wave loop 51. Exemplarily, as shown in the figure, the second wave loop 51 is located within the end segment 11, and the crest of the first wave segment 21 and one of the crests of the second wave loop 51 are spaced apart along the axial direction of the coating support 100.

[0123] Please see Figure 17 In some embodiments, the second wave 51 includes a third wave 511 and a fourth wave 512. The radial support strength of the third wave 511 is less than that of the fourth wave 512. The fourth wave 512 is coaxially arranged with the first waveform segment 21, and the third wave 511 is coaxially arranged with the second waveform segment 22. This allows the second wave 51 to balance the circumferential support strength of the first region 100a, making the circumferential release of the first region 100a more uniform, and thus making the circumferential force exerted by the first region 100a and the covered stent 100 on the vascular inner wall more uniform.

[0124] For example, at least one third wave 511 can be provided between two adjacent fourth waves 512, and at least one fourth wave 512 can be provided between two adjacent third waves 511.

[0125] In some embodiments, the wave height of the third wave 511 is equal to the wave height of the fourth wave 512, and the wave angle of the third wave 511 is smaller than the wave angle of the fourth wave 512, so that the radial support strength of the third wave 511 is less than the radial support strength of the fourth wave 512. In other embodiments, the wave height of the third wave 511 may also be less than or greater than the wave height of the fourth wave 512, and the wave angle of the third wave 511 may also be greater than or equal to the wave angle of the fourth wave 512. This is not limited, as long as the radial support strength of the third wave 511 is less than the radial support strength of the fourth wave 512.

[0126] For example, the first waveform segment 21 includes a first wave 21a, and the second waveform segment 22 includes a second wave 22a. The wave height of the first wave 21a is greater than that of the second wave 22a, and the wave angle of the first wave 21a is equal to that of the second wave 22a. The wave height of the third wave 511 is equal to that of the fourth wave 512, and the wave angle of the third wave 511 is less than that of the fourth wave 512. This allows the second wave ring 51 to effectively balance the radial support strength of the region in the first region 100a that is coaxial with the first waveform segment 21 and the region in the first region 100a that is coaxial with the second waveform segment 22, reducing the difference in release speed between the two regions in the first region 100a that are coaxial with the first waveform segment 21 and the region in the first region 100a that is coaxial with the second waveform segment 22. This results in a more uniform circumferential release of the first region 100a. In addition, both the first wave ring 20 and the second wave ring 51 can strengthen the support end segment 11, effectively ensuring that the first region 100a adheres well to the wall after release.

[0127] Please see Figure 17 For example, the third wave 511 includes a fifth wave rod 5111 and a sixth wave rod 5112, and adjacent fifth wave rods 5111 and sixth wave rods 5112 are connected to the same third wave peak 5113 to form the third wave 511. The fourth wave 512 includes a seventh wave rod 5121 and an eighth wave rod 5122, and adjacent seventh wave rods 5121 and eighth wave rods 5122 are connected to the same fourth wave peak 5123 to form the fourth wave 512.

[0128] For example, the wave bar of the third wave 511 can be a straight line, a broken line, or a curve. See, for instance, [link to relevant documentation]. Figure 17 The wave rod of wave 511 in the third wave and / or the wave rod of wave 512 in the fourth wave include straight lines. For example, please refer to... Figure 18 The wave rods of the third wave 511 and / or the fourth wave 512 include broken lines. The curved third wave 511 can extend more easily without interfering with other waves, thereby making it easier to support the end face 112 of the end segment 11 to a certain extent, and further enabling the end face 112 of the end segment 11 to maintain a good shape after the film-coated support 100 is compressed and released.

[0129] For example, the number of crests in the first wave circle 20 and the number of crests in the second wave circle 51 may be the same or different, and there is no restriction here. The number of crests in the first wave 21a and the third wave 511 may be the same or different; the number of crests in the second wave 22a and the fourth wave 512 may be the same or different.

[0130] Please see Figure 18 In some embodiments, the balancing structure 50 further includes a third wavering 52 connected to the end segment 11. The third wavering 52 increases the radial support strength of the region in the first region 100a coaxial with the first wavering segment 21, thereby balancing the radial support strength of the regions in the first region 100a coaxial with the first wavering segment 21 and the regions in the first region 100a coaxial with the second wavering segment 22. This reduces the difference in release speed between the regions in the first region 100a coaxial with the first wavering segment 21 and the regions in the first region 100a coaxial with the second wavering segment 22, resulting in more uniform circumferential release of the first region 100a and the covered stent 100. Furthermore, the third wavering 52 also strengthens the support of the end segment 11, ensuring that the first region 100a adheres well to the wall after release, preventing the first region 100a from developing a beak-like shape that could lead to bleeding. In this embodiment, the third wavering 52 is also an annular wavering, with a partially overlapping area with the second wavering 51.

[0131] Please see Figure 18 In some embodiments, the second wave loop 51 is used to form a closed structure 53, which is coaxially arranged with the first wave segment 21. It is understood that since the second wave loop 51 and the third wave loop 52 are both fixed to the coating body 10, the closed structure 53 is also fixed to the coating body 10. In particular, the apexes of the closed structure 53 are fixed. When the coating support 100 is radially compressed, the proximal apex of the closed structure 53 moves proximally, and the distal apex of the closed structure 53 moves distally. At this time, the coating portion surrounded by the closed structure 53 is simultaneously stretched axially towards the proximal end and axially towards the distal end. When the coating portion in the closed structure 53 is stretched to its limit, the closed structure 53 is difficult to be radially compressed further. Therefore, the coating portion surrounded by the closed structure 53 hinders the radial compression of the closed structure 53, making it difficult for the closed structure 53 to be radially compressed. Thus, the radial support strength of the closed structure 53 is greater than that of the non-closed structure.

[0132] Please see Figure 18 In some embodiments, the third wave loop 52 intersects and cooperates with the second wave loop 51 to form a closed structure 53, thereby further increasing the radial support strength of the region in the first region 100a that is coaxial with the first wave segment 21, so as to make the first region 100a release more evenly in the circumferential direction.

[0133] Please see Figure 18 In some embodiments, one of the troughs of the third wave ring 52 and one of the peaks of the second wave ring 51 are spaced apart along the axial direction of the film-coated support 100, and the third wave ring 52 intersects with the second wave ring 51 so that the second wave ring 51 and the third wave ring 52 cooperate to form a closed structure 53.

[0134] Please see Figure 18 In some embodiments, the axial region of the third wave ring 52 at least partially overlaps with the axial region of the second wave ring 51 to improve the support performance of the balancing structure 50, so that the balancing structure 50 can better balance the circumferential radial support strength of the first region 100a and the covered support 100, and further improve the circumferential release uniformity of the first region 100a and the covered support 100.

[0135] For example, the heights of the waves in the third wave loop 52 may be the same, different, or partially the same, without limitation.

[0136] Please see Figure 18 In some embodiments, the wave height of the third wave loop 52 is lower than that of the second wave loop 51, and the axial region of the third wave loop 52 is located within the axial region of the second wave loop 51. Thus, the balancing structure 50 can balance the circumferential radial support strength of the covered stent 100, and also facilitates a more compact structure for the covered stent 100. Furthermore, the reduced axial distance between the third wave loop 52 and the second wave loop 51 increases the radial support strength at the proximal end of the covered stent 100, thereby increasing the anchorage of the proximal end of the covered stent 100 in the blood vessel, making it less prone to displacement within the blood vessel. Exemplarily, the distal end (at least part of the trough) of the third wave loop 52 is flush with the distal end (at least part of the trough) of the second wave loop 51.

[0137] In some embodiments, the number of peaks in the third wavering 52 is greater than or equal to the number of peaks in the second wavering 51 to improve the radial support performance of the balancing structure 50, enabling the balancing structure 50 to better balance the circumferential radial support strength of the first region 100a and the covered support 100. For example, the number of peaks in the third wavering 52 is twice the number of peaks in the second wavering 51. In other embodiments, the number of peaks in the third wavering 52 may also be less than the number of peaks in the second wavering 51.

[0138] For example, the crest of the third wave loop 52 is further away from the end face 112 of the end segment 11 than the crest of the second wave loop 51, so that the connection between the second wave loop 51 and the third wave loop 52 and the end segment 11 is convenient, simple and easy.

[0139] Understandably, at least some of the crests of the third wave loop 52 can be located at any suitable position. For example, at least some of the crests of the third wave loop 52 can be located on at least one of the fifth wave lever 5111, the sixth wave lever 5112, the seventh wave lever 5121, and the eighth wave lever 5122. Alternatively, the crests of the third wave loop 52 can be located at at least one of the following: between the fifth wave lever 5111 and the sixth wave lever 5112; between the sixth wave lever 5112 and the seventh wave lever 5121; between the seventh wave lever 5121 and the eighth wave lever 5122; or between the eighth wave lever 5122 and the fifth wave lever 5111.

[0140] For example, the axial region of the third wave loop 52 is located within the axial region of the end segment 11, and the axial region of the third wave loop 52 is located within the axial region of the second wave loop 51. This is to better increase the radial support strength of the region in the first region 100a that is coaxial with the first wave segment 21, so that the force exerted by the first region 100a on the circumferential wall of the blood vessel is more uniform, reducing or avoiding the phenomenon of force concentration on the inner wall of the blood vessel, thereby reducing or avoiding damage to the blood vessel. In addition, it can also make the end segment 11 more uniformly released, ensuring that the end segment 11 can maintain its shape better after release, so that the end segment 11 can better fit the inner wall of the blood vessel, improving the wall adhesion of the end segment 11 of the covered stent 100, thereby avoiding endoleak.

[0141] The shape of the closed structure 53 can be set according to actual needs, and may include at least one of the following: quadrilateral, pentagon, hexagon, other polygons, other irregular closed shapes, etc. For example, please refer to... Figure 18 The shape of the closed structure 53 includes quadrilaterals or rhombuses. For example, please refer to... Figure 19 The closed structure 53 has a hexagonal shape.

[0142] In one embodiment, the balancing structure 50 includes at least one of the following: a second wave coil 51, a third wave coil 52, a fourth wave coil 54, and other wave coils. See also... Figure 20For example, the balancing structure 50 includes a second wave ring 51, a third wave ring 52, and a fourth wave ring 54. The second wave ring 51, the third wave ring 52, and the fourth wave ring 54 are respectively connected to the end segment 11. The fourth wave ring 54 may intersect with the second wave ring 51 and / or the third wave ring 52. The balancing structure 50 including multiple wave rings can effectively increase the radial support strength of the region in the first region 100a that is coaxial with the first wave segment 21. When the radial support strength between the wave segments in the circumferential direction of the first wave ring 20 is too different, or the radial support strength of the proximal end of the covered stent 100 is too small, a balancing structure 50 including multiple wave rings can be set at the corresponding position to make the radial support strength of the proximal end (or the first region 100a) of the covered stent 100 as appropriate as possible and the circumferential release of the proximal end of the covered stent 100 more uniform. Furthermore, each wave loop of the balancing structure 50 can also support the end segment 11, ensuring that the first region 100a can adhere well to the wall after release, avoiding the bird's beak shape at the end of the covered stent 100 that could lead to blood leakage. For example, the second wave loop 51, the third wave loop 52, and the fourth wave loop 54 are all continuous waveform structures.

[0143] Understandably, the wire diameter, wave height, wave number and / or wave angle of the second wave 51, the third wave 52 and the fourth wave 54 can be set according to actual needs, and there are no restrictions here.

[0144] In some implementations, the diameter of the third wave loop 52 is smaller than that of the second wave loop 51. The function of the third wave loop 52 is to supplement the radial support of the second wave loop 52. However, the radial support strength of the third wave loop 52 should not be too great, otherwise it may easily cause the first region 100a to irritate blood vessels or even rupture blood vessels.

[0145] Please see Figure 21 In some embodiments, within the first region 100a, there is at least one first intersection point 61 within a region coaxial with the first waveform segment 21. The first intersection point 61 is formed by the intersection of the first waveform segment 21 and the balancing structure 50, or by the balancing structure 50 itself. This increases the radial support strength of the first region 100a, resulting in a more uniform upward release of the first region 100 along the axial direction. Please refer to [link to relevant documentation]. Figure 21In some embodiments, the first intersection point 61 is formed by the intersection of at least two of the second wave loop 51, the third wave loop 52, and the fourth wave loop 54 of the balancing structure 50. For example, the number of first intersection points 61 includes six, denoted as intersection point D1, intersection point D2, intersection point D3, intersection point D4, intersection point D5, and intersection point D6, respectively. The third wave loop 52 and the fourth wave loop 54 intersect in a region coaxial with the first waveform segment 21 to form intersection points D1 and D2, and the second wave loop 51, the third wave loop 52, and the fourth wave loop 54 intersect in a region coaxial with the first waveform segment 21 to form intersection points D3 and D4. The second wave loop 51 and the third wave loop 52 intersect in a region coaxial with the first waveform segment 21 to form intersection points D3 and D4. Intersection points D5 and D6 are formed in the region coaxial with the first waveform segment 21. Thus, the combination of the third wave loop 52 and the fourth wave loop 54, the combination of the second wave loop 51, the third wave loop 52 and the fourth wave loop 54, and the combination of the second wave loop 51 and the third wave loop 52 can each act as a whole to resist radial extrusion force, thereby further improving radial support force, improving the wall adhesion of the first region 100a and the proximal end of the covered stent 100, and avoiding the problem of blood leakage.

[0146] In some embodiments, intersection points D1 and D2 are symmetrically arranged about a first preset straight line, intersection points D3 and D4 are symmetrically arranged about a first preset straight line, and intersection points D5 and D6 are symmetrically arranged about a first preset straight line. This makes the radial support performance of the first region 100a more uniform and improves the adhesion between the first region 100a and the film-coated support 100. For example, the first preset straight line passes through the crest of the first wave 21a, and the first preset straight line passes through the crest of the region in the second wave loop 51 that is coaxial with the first wave 21a. For example, the first preset straight line is as follows... Figure 21 The dashed line n1 is shown in the figure.

[0147] Please see Figure 21In some embodiments, in the first region 100a, there are multiple second intersection points 62 in the region coaxial with the second waveform segment 22, the number of first intersection points 61 is greater than the number of second intersection points 62, wherein the second intersection point 50a is formed by the intersection of the second waveform segment 22 and the balancing structure 50 or by the balancing structure 50 itself. The number of first intersection points 61 is greater than the number of second intersection points 62, which helps the balancing structure 50 to better balance the radial support strength of the regions in the first region 100a that are coaxial with the first waveform segment 21 and the regions in the first region 100a that are coaxial with the second waveform segment 22. This effectively reduces the difference in release speed between the regions in the first region 100a that are coaxial with the first waveform segment 21 and the regions in the first region 100a that are coaxial with the second waveform segment 22. As a result, the first region 100a and the covered stent 100 are released more evenly in the circumferential direction, and the force exerted by the first region 100a and the covered stent 100 on the circumferential wall of the blood vessel is more even. This reduces the phenomenon of concentrated force on the inner wall of the blood vessel, reduces the stimulation and damage to the blood vessel during the release process, and also helps the end segment 11 or the first region 100a to maintain its shape better after the covered stent 100 is compressed and released, so that the first region 100a and the covered stent 100 have good wall adhesion.

[0148] Please see Figure 21 In some embodiments, the second intersection point 62 is formed by the intersection of at least two of the second wave coil 51, the third wave coil 52, and the fourth wave coil 54 of the balancing structure 50. For example, the number of second intersection points 62 includes two, denoted as intersection point H1 and intersection point H2, respectively. The second wave coil 51, the third wave coil 52, and the fourth wave coil 54 intersect in a region coaxial with the second waveform segment 22 to form intersection points H1 and H2. The combination of the second wave coil 51, the third wave coil 52, and the fourth wave coil 54 can resist radial extrusion force as a whole, thereby further improving the radial support force, improving the wall adhesion of the first region 100a and the proximal end of the covered stent 100, and avoiding the problem of blood leakage.

[0149] In some embodiments, intersection points H1 and H2 are symmetrically arranged about a second preset straight line, making the radial support performance of the first region 100a more uniform and improving the wall adhesion of the first region 100a and the film-coated support 100. Exemplarily, the second preset straight line passes through the crest of the second wave 22a, and the second preset straight line passes through the crest of the region in the second wave loop 51 that is coaxial with the second wave 22a. Exemplarily, the second preset straight line is as follows... Figure 21 The dashed line n2 is shown in the figure.

[0150] For example, the membrane-coated support 100 can be prepared by weaving metal wires into the desired waveform. The metal wires can be nickel-titanium alloy wires with a diameter of, for example, 0.35 mm. After heat setting, a steel sleeve is used to connect the two ends of the metal wire, and the connection is secured by mechanical compression, thus forming a metal ring. After the waveform ring structure is fabricated, a membrane is coated onto the surface of the sequentially arranged multi-turn waveform ring structure. For example, an e-PTFE membrane can be integrally coated onto the inner and outer surfaces of the multi-turn waveform ring structure, with the multi-turn waveform ring structure located between the two membrane layers. The inner and outer e-PTFE membrane layers are bonded together by high temperature and pressure, thereby fixing the multi-turn waveform ring structure between the two membrane layers. Of course, when the waveform ring structure is formed by integrally cutting a metal tube, it is not necessary to use a steel sleeve for fixation. Alternatively, an e-PTFE membrane can be integrally coated onto either the inner or outer surface of the multi-turn waveform ring structure.

[0151] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," "mechanical coupling," and "coupling" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection. They can refer to a mechanical connection or an electrical connection. They can refer to a direct connection or an indirect connection through an intermediate medium, and can refer to the internal communication of two components or the interaction between two components. Mechanical coupling or coupling of two components includes direct coupling and indirect coupling, such as a direct fixed connection or a connection through a transmission mechanism. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0152] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0153] The foregoing disclosure provides many different embodiments or examples for implementing various structures of the invention. To simplify the disclosure, specific examples of components and arrangements are described above. These are merely examples and are not intended to limit the invention. Furthermore, reference numerals and / or letters may be repeated in different examples; such repetition is for simplification and clarity and does not in itself indicate a relationship between the various embodiments and / or arrangements discussed. In addition, examples of various specific processes and materials are provided in this invention, but those skilled in the art will recognize the application of other processes and / or the use of other materials.

[0154] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific method step, feature, structure, material, or characteristic described in connection with an embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific method steps, features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0155] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in the present invention, and these modifications or substitutions should all be covered 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, characterized in that, include: The film-coated body includes an end segment having an open end and a main body segment connected to the end segment; The first wave loop is connected to the end segment and fixed relative to the end segment; A connecting portion, formed in at least one of the end section and the first wave coil, is used for connection with the conveyor; The end face of the end segment includes a first part end face and a second part end face that are connected to each other. The first part end face and the second part end face are arranged circumferentially along the film-coating body. Compared with the second part end face, the first part end face protrudes in a direction away from the main body segment. An outwardly convex region is formed between the surface where the second part end face is located or the surface where the cross section of the second part end face is furthest from the main body segment in a direction perpendicular to the axial direction of the film-coating support and the first part end face. At least one end of the connecting portion that is furthest from the main body segment is located in the outwardly convex region and is used to drive the outwardly convex region to be positioned on the conveyor.

2. The covered stent according to claim 1, characterized in that, The connecting portion is located within the convex region.

3. The covered stent according to claim 1, characterized in that, The first wave includes a first wave and a second wave. The peak of the first wave protrudes further away from the main body than the peak of the second wave, and the peak of the first wave is located in the outwardly convex region.

4. The covered stent according to claim 3, characterized in that, The crest of the second wave is adjacent to or located on the end face of the second part.

5. The covered stent according to claim 1, characterized in that, The connecting portion includes a connecting line or a connecting strip, which connects to at least one of the end segment and the first wave coil; or, the connecting portion includes a connecting hole or a connecting seam, which penetrates the end segment.

6. The covered stent according to claim 1, characterized in that, The connecting part includes a connecting membrane, a portion of the first wave coil is disposed between the end section and the connecting membrane, and an insertion port is provided between the end section and the connecting membrane for inserting the conveyor and connecting to the conveyor.

7. The covered stent according to claim 6, characterized in that, The connecting membrane and the end segment are an integral structure.

8. The covered stent according to claim 6, characterized in that, The connecting membrane is made of a material with developing function.

9. The covered stent according to claim 1, characterized in that, The connecting portion includes a first end away from the main body segment and a second end close to the main body segment, wherein the first end is closer to the longitudinal central axis of the covered stent than the second end.

10. The covered stent according to claim 1, characterized in that, The number of the first part end faces includes at least two, and multiple first part end faces are arranged at circumferential intervals.

11. The covered stent according to claim 5, characterized in that, When the connecting portion includes a connecting hole or a connecting seam, the film-coated bracket also includes a second wave ring, which is connected to the end segment, and one of the wave crests of the second wave ring is disposed adjacent to the connecting hole or connecting seam.

12. The covered stent according to any one of claims 1-11, characterized in that, The first wave loop includes a first wave segment and a second wave segment. The radial support strength of the first wave segment is less than the radial support strength of the second wave segment. The region where the end segment of the covered support is located is the first region. The covered support also includes: A balancing structure is disposed within the first region to increase the radial support strength of the region within the first region that is coaxial with the first waveform segment.

13. A conveying system, characterized in that, include: Conveyor; as well as The covered stent as described in any one of claims 1-12, wherein the conveyor is used to convey the covered stent.

Images