Sheathed stent and delivery system

Abstract

The present application provides a sheathed stent (100) and a delivery system (1000). The sheathed stent (100) comprises a sheath body (10), a first wavy ring (20), and a balance structure (50). The sheath body (10) comprises an end section (11) having an open end (111). The first wavy ring (20) is connected to the end section (11). The first wavy ring (20) comprises a first wavy section (21) and a second wavy section (22). The radial support strength of the first wavy section (21) is less than that of the second wavy section (22). The region where the end section (11) on the sheathed stent (100) is located is a first region (100a). The balance structure (50) is provided in the first region (100a) and configured for increasing the radial support strength of a region in the first region (100a) coaxial to the first wavy section (21). The sheathed stent (100) and the delivery system (1000) provided in the present application allow a more uniform release of the first region (100a) and the sheathed stent (100) in the circumferential direction, thus reducing the irritation and damage to blood vessels in the release process.

Description

Stent graft and delivery system Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a stent graft and a delivery system. Background Art

[0002] Aortic aneurysm and aortic dissection are diseases that currently pose a serious threat to human life. If not actively treated, the aortic aneurysm and dissection will continue to grow and 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 surgical treatments for aortic aneurysms and aortic dissections are characterized by significant trauma, high mortality, prolonged operative times, high rates of postoperative complications, and high surgical difficulty. Endovascular surgery, however, offers minimal trauma, fewer postoperative complications, shorter operative times, and reduced surgical difficulty, making it the primary treatment for these conditions. Endovascular surgery involves implanting a covered stent graft into the aorta via a delivery device, isolating the vascular lesion and restricting blood flow to the inside of the graft, thereby protecting the vessel.

[0004] However, the end section of the stent graft in the related art is provided with a first wave coil, which includes a first waveform segment and a second waveform segment connected to the first waveform segment. The radial support strength of the first waveform segment is less than that of the second waveform segment. When the stent graft is released from the conveyor, the first wave coil will rebound under the action of its own elastic force. During the rebound process, the first wave coil will drive the end section of the stent graft to contact the inner wall of the blood vessel. However, since the radial support strength of the first waveform segment is less than that of the second waveform segment, the second waveform segment rebounds faster than the first waveform segment. The end section of the stent graft is released unevenly in the circumferential direction, resulting in uneven circumferential force exerted by the end section of the stent graft on the inner wall of the blood vessel, which easily causes the force inside the blood vessel to be more concentrated. During the release process, it is easy to cause impact or damage to the blood vessel, causing discomfort to the patient and even vascular spasm.

[0005] Summary of the Invention

[0006] In response to the deficiencies in the above-mentioned technologies, the present application provides a coated stent and a delivery system.

[0007] The present invention provides a stent graft, comprising:

[0008] a covering body including an end section having an open end;

[0009] a first wave ring connected to the end segment; the first wave ring includes a first waveform segment and a second waveform segment, the radial support strength of the first waveform segment is less than the radial support strength of the second waveform segment, and the area where the end segment on the stent graft is located is the first area;

[0010] The balancing structure is arranged in the first region and is used to increase the radial support strength of a region in the first region that is coaxial with the first corrugated segment.

[0011] In the stent graft of the embodiment of the present application, the balancing structure includes a second wave ring connected to the end segment.

[0012] In the stent graft of the embodiment of the present application, the axial region of the second wave ring at least partially overlaps with the axial region of the first wave ring.

[0013] In the coated stent of the embodiment of the present application, the second wave ring includes a third wave and a fourth wave, the radial support strength of the third wave is less than the radial support strength of the fourth wave, the fourth wave is coaxially arranged with the first waveform segment, and the third wave is coaxially arranged with the second waveform segment.

[0014] In the coated stent of an embodiment of the present application, the first waveform segment includes a first wave, the second waveform segment includes a second wave, the wave height of the first wave is greater than the wave height of the second wave, the wave angle of the first wave is equal to the wave angle of the second wave, the wave height of the third wave is equal to the wave height of the fourth wave, and the wave angle of the third wave is greater than the wave angle of the fourth wave.

[0015] In the stent graft of the embodiment of the present application, the second wave ring is used to form a closed structure, and the closed structure is arranged coaxially with the first wave segment.

[0016] In the stent graft of the embodiment of the present application, the balancing structure further includes a third wave ring connected to the end segment, and the third wave ring intersects and cooperates with the second wave ring to form the closed structure.

[0017] In the stent graft of the embodiment of the present application, the wire diameter of the third wave coil is smaller than the wire diameter of the second wave coil.

[0018] In the coated stent of the embodiment of the present application, in the first region, there is at least one first intersection in the region coaxial with the first waveform segment, wherein the first intersection is formed by the intersection of the first waveform segment and the balancing structure or by the balancing structure itself.

[0019] In the coated stent of an embodiment of the present application, in the first region, there are multiple second intersections in the region coaxial with the second waveform segment, and the number of the first intersections is greater than the number of the second intersections, wherein the second intersections are formed by the intersection of the second waveform segment and the balance structure or by the balance structure itself.

[0020] In the stent graft of the embodiment of the present application, the balancing structure is at least partially provided on the end surface of the graft body or adjacent to the end surface of the graft body for supporting the end surface of the graft body.

[0021] The present application also provides a delivery system, including:

[0022] conveyor; and

[0023] The coated stent as described in any of the above items, wherein the conveyor is used to convey the coated stent.

[0024] The coated stent and delivery system provided in the embodiment of the present application include a balancing structure connected to the end segment, and the balancing structure is used to increase the radial support strength of the area coaxial with the first waveform segment in the first region. The balancing structure can balance the radial support strength of the area coaxial with the first waveform segment in the first region and the area coaxial with the second waveform segment in the first region, reduce the difference between the release speed of the area coaxial with the first waveform segment in the first region and the area coaxial with the second waveform segment in the first region, thereby making the release of the first region and the coated stent more uniform in the circumferential direction, making the circumferential force of the first region and the coated stent on the inner wall of the blood vessel more uniform, reducing the occurrence of the phenomenon of more concentrated force on the inner wall of the blood vessel, and reducing the irritation and damage to the blood vessel during the release process.

[0025] It should be understood that the above general description and the following detailed description are merely exemplary and explanatory and do not limit the disclosure of the embodiments of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the description of the embodiments. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0027] FIG1 is a schematic structural diagram of a conveying system provided in one embodiment of the present application;

[0028] FIG2 is a schematic structural diagram of a stent graft provided in one embodiment of the present application;

[0029] FIG3 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0030] FIG4 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0031] FIG5 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0032] FIG6 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0033] FIG7 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0034] FIG8 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0035] FIG9 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0036] FIG10 is a schematic diagram of the position of a connecting portion provided in one embodiment of the present application;

[0037] FIG11 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0038] FIG12 is a schematic diagram of the position of a connecting portion provided in one embodiment of the present application;

[0039] FIG13 is a schematic diagram of the position of the connecting portion provided in one embodiment of the present application and an enlarged view of portion A thereof.

[0040] FIG14 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0041] FIG15 is a schematic diagram of a partial structure of a stent graft provided in one embodiment of the present application;

[0042] FIG16 is a schematic diagram of a partial structure of an end section after expansion according to an embodiment of the present application;

[0043] FIG17 is a schematic diagram of a partial structure of an expanded end section provided in one embodiment of the present application;

[0044] FIG18 is a schematic diagram of a partial structure of an expanded end section provided in one embodiment of the present application;

[0045] FIG19 is a schematic diagram of a partial structure of an expanded end section provided in one embodiment of the present application;

[0046] FIG20 is a schematic diagram of a partial structure of an end section after expansion according to an embodiment of the present application;

[0047] FIG21 is a schematic diagram of a partial structure of an end section after expansion according to an embodiment of the present application;

[0048] FIG22 is a schematic diagram of a partial structure of the end section after unfolding provided in one embodiment of the present application.

[0049] Explanation of Reference Numerals: 1000, delivery system; 100, stent graft; 100a, first region; 10, graft body; 11, end segment; 111, open end; 1111, proximal open end; 1112, distal open end; 112, end surface; 1121, first portion end surface; 1122, second portion end surface; 11a, convex region; 12, main body segment; 20, first wave ring; 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, portion of the first wave ring 20 at least partially exposed axially outside the graft body 10; 30, supporting frame; 40. Connecting part; 41. Connecting line; 42. Connecting belt; 43. Connecting hole; 44. Connecting seam; 441. Open end of connecting seam; 45. Connecting membrane; 450. Insertion port; 451. Suture line; 50. Balancing structure; 51. Second wave ring; 511. Third wave; 5111. Fifth wave rod; 5112. Sixth wave rod; 5113. Third wave peak; 512. Fourth wave; 5121. Seventh wave rod; 5122. Eighth wave rod; 5123. Fourth wave peak; 52. Third wave ring; 53. Closing structure; 54. Fourth wave ring; 61. First intersection; 62. Second intersection; 200. Conveyor; 201. Sheath tube; 202. Sheath core; 203. Anchor. DETAILED DESCRIPTION

[0050] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0051] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the said features. In the description of the present application, "multiple" means two or more, unless otherwise clearly and specifically defined.

[0052] It should also be understood that the terms used in this specification are only for the purpose of describing specific embodiments and are not intended to limit the present application. 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.

[0053] It should be further understood that the term "and / or" used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

[0054] The following describes some embodiments of the present application in detail with reference to the accompanying drawings. In the absence of conflict, the following embodiments and features therein may be combined with each other.

[0055] For ease of description, the terms "proximal" and "distal" are defined here as commonly used 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 stent graft is implanted in a lumen, blood flows from the proximal end to the distal end. "Axial" refers to its length, or the direction in which an interventional device is advanced and ejected. "Radial" refers to the direction perpendicular to the "axial" direction.

[0056] Taking blood vessels as an example to illustrate lumens, the blood vessels may include, but are not limited to, at least one of the following: the ascending aorta, the aortic arch, the descending aorta, the thoracic aorta, the abdominal aorta, and veins. Those skilled in the art should understand that the use of blood vessels as an example is merely illustrative and does not limit this application. The solutions of this application are applicable to various human or animal lumens, including, for example, the lumen of the digestive tract or blood vessels. Various improvements and variations based on the teachings of this application are within the scope of protection of this application.

[0057] The "corrugated ring" in the embodiments of the present application is a closed or open wavy annular structure, also referred to as a wavy annular structure, which can be disposed on the inner and / or outer wall of the stent graft body. The corrugated ring is connected to the stent graft body by at least one of the following connection methods: suturing, bonding, hot melting, etc. For example, at least a portion of the corrugated ring can be made of a material having excellent tensile strength, resilience, and biocompatibility. For example, the material includes at least one of the following: a known material 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 corrugated ring has radial expansion capability and can achieve radial contraction under the action of an external force. After the external force is removed, it can self-expand or mechanically expand (e.g., by balloon expansion) to restore to its original shape and maintain its original shape. Thus, after implantation into the lumen, it can adhere closely to the inner wall of the lumen through its radial support force. The waveform of the wave loop is not limited and can include at least one of the following: Z-shaped wave, M-shaped wave, V-shaped wave, sine wave, etc. The wave loop includes multiple peaks (also known as proximal vertices), multiple troughs (also known as distal vertices), and wave rods connecting adjacent peaks and troughs. A vertex (proximal vertex or distal vertex) and the two wave rods connected to it form a wave.

[0058] It is understood that the "wave number" referred to in the embodiments of this application refers to the number of wave crests or troughs. "Wave height" refers to the vertical distance between a wave crest and the shortest adjacent trough. "Wave angle" refers to the angle between two adjacent wave bars connecting the same vertex.

[0059] It is understood that the radial support force (unit: N) can be measured using a radial support force tester, such as the RX550-100 radial support force tester from Machine Solution Inc. (MSI). Taking the first corrugated ring as an example, the first corrugated ring is placed in the radial crimper of the tester. During the test, the radial crimper is maintained to uniformly compress the first corrugated ring radially until it is compressed to 20% of its original diameter. The radial support force value of the first corrugated ring at this point is then measured.

[0060] The following method can be used to measure that the radial supporting force of the first wave of the first wave ring is smaller than the radial supporting force of the second wave of the first wave ring: make a first test wave ring composed of multiple first waves, and the diameter of the first test wave ring is the same as the diameter of the first wave ring; make a second test wave ring composed of multiple second waves, and the diameter of the second test wave ring is the same as the diameter of the first wave ring; test the radial supporting force of the first test wave ring and the radial supporting force of the second test wave ring respectively, and obtain that the radial supporting force of the first test wave ring is smaller than the radial supporting force of the second test wave ring. Since the first wave and the second wave are both on the first wave ring, the maximum axial length of the first wave ring is the same value, and then it can be calculated that the radial supporting force of the first wave of the first wave ring is smaller than the radial supporting force of the second wave of the first wave ring.

[0061] The radial support strength (unit: Pa) mentioned in the embodiments of this application can be calculated using the following formula: Radial Support Strength = Radial Support Force / Maximum Axial Length of the Measured Location. It is understood that when multiple axially disposed corrugated rings are disposed at the measured location, the closer the axially disposed corrugated rings are, the greater the radial support strength.

[0062] It should be noted that A equals B means that A equals B within the range of assembly and / or installation error, or that A is approximately equal to B.

[0063] Please refer to Figure 1. An embodiment of the present application provides a delivery system 1000, including a coated stent 100 and a delivery device 200. The delivery device 200 is used to deliver the coated stent 100 to deliver the coated stent 100 to the location of vascular lesions, thereby isolating the vascular lesions outside the coated stent 100, thereby achieving the purpose of protecting the blood vessels.

[0064] Referring to FIG1 , in some embodiments, a delivery device 200 includes a sheath core 201 and a sheath tube 202. The sheath core 201 passes through the sheath tube 202, which is capable of accommodating and delivering the stent graft 100. When the stent graft 100 needs to be delivered to the location of a vascular lesion, the stent graft 100 can first be connected to the anchor 203 of the delivery device 200, and the stent graft 100 can be compressed and loaded between the sheath tube 202 and the sheath core 201 to facilitate delivery of the stent graft 100.

[0065] It can be understood that the coated stent 100 can be radially compressed and loaded in the sheath 202 of the conveyor 200. After the coated stent 100 is implanted into the lesion site through the conveyor 200, the coated stent 100 can isolate the blood flow from the lesion site, eliminate the influence of blood pressure on the lesion site, and achieve the purpose of healing.

[0066] Referring to Figure 2 , in some embodiments, a stent graft 100 includes a graft body 10 and a first corrugated ring 20. The graft body 10 includes an end segment 11 having an open end 111. The first corrugated ring 20 is connected to and fixed relative to the end segment 11. It will be understood that the graft body 10 includes a hollow tubular structure, and the hollow cavity of the graft body 10 constitutes a blood flow channel.

[0067] Referring to FIG. 2 , in some embodiments, the membrane body 10 has at least a proximal open end 1111 and a distal open end 1112. The first wave ring 20 can be provided at the end segment 11 of the membrane body 10 where the proximal open end 1111 is located, or at the end segment 11 where the distal open end 1112 is located, or at both ends of the membrane body 10, depending on actual needs. For example, the first wave ring 20 is provided at the proximal open end 1111 of the membrane body 10.

[0068] Please refer to Figure 2. In some embodiments, the coating body 10 also includes a main body segment 12, and the coated stent 100 also includes a support skeleton 30. The end segment 11 is connected to the main body segment 12; the support skeleton 30 is connected to the main body segment 12, and the support skeleton 30 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 support skeleton 30 has radial expansion capability, which can achieve radial contraction under the action of external force, and self-expand to restore to the original shape and maintain the original shape after the external force is removed, so that after being implanted in the blood vessel, it can cling to the inner wall of the blood vessel through its radial support force. Exemplarily, the main body segment 12 includes a tubular main coating, and the support skeleton 30 includes at least one support wave ring.

[0069] For example, both the main body coating and the end coatings can be single-layer or multi-layer structures, without limitation. Both the main body coating and the end coatings 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 coating can be secured to the inner and / or outer surfaces of the support frame 30 by suturing, bonding, hot-melting, or the like, thereby reconstructing fluid pathways and isolating vascular lesions.

[0070] Illustratively, the axial region of the end segment 11 is shown as A1 in FIG. 2 , and the axial region of the main body segment 12 is shown as B in FIG. 2 .

[0071] In some embodiments, the end segment 11 includes a tubular end coating, and the open end 111 of the end segment 11 can be formed by enclosing the edge or end surface 112 (see Figure 3) of the end coating. Exemplarily, an end support assembly is provided on the end segment 11, and the end coating can be fixed to the inner surface and / or outer surface of the end support assembly by suturing, bonding, hot melting, etc. The end support assembly includes a first wave ring 20 connected to the end segment 11. In other embodiments, the end support assembly also includes other wave rings connected to the end segment 11 to further increase the radial anchoring force of the coating body 10 and further improve the stability of the coated stent 100 during use.

[0072] 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 that in the second state. The second state can be a naturally expanded state, i.e., a naturally extended state without any artificial force, or a state in which the end segment 11 is radially compressed to a certain extent but not yet fully expanded. In either state, the radial dimension is larger than that in the first state.

[0073] Referring to FIG3 , in some embodiments, at least a portion of the first corrugated ring 20 is axially exposed outside the end section 11. When the end section 11 is in the first state, at least a portion of the first corrugated ring 20 axially passes over the end surface 112 of the end section 11, so that the first corrugated ring 20 is at least partially exposed axially outside the graft body 10. The first corrugated ring 20 exposed outside the graft body 10 is easily connected to the conveyor 200, and the graft stent 100 can be simply, easily, and quickly loaded onto the conveyor 200. In this embodiment, the portion 2011 of the first corrugated ring 20 at least partially exposed axially outside the graft body 10 is tilted toward the central axis of the graft body 10, making it easier for the portion 2011 of the first corrugated ring 20 at least partially exposed axially outside the graft body 10 to be released from the conveyor 200.

[0074] Please refer to Figure 3. For example, the first wave coil 20 can partially extend beyond the coating body 10 in the axial direction, and the first wave coil 20 extending beyond the coating body 10 is bent toward the axial direction of the coated stent 100, so that the part of the first wave coil 20 extending beyond the coating body 10 will not contact the inner wall of the blood vessel after the coated stent 100 is implanted in the blood vessel, thereby avoiding the first wave coil 20 from causing damage or greater stimulation to the inner wall of the blood vessel.

[0075] Referring to Figures 4 and 5 , in some embodiments, the first corrugated ring 20 is located within the end section 11. The stent graft 100 further includes a connecting portion 40 formed on at least one of the end section 11 and the first corrugated ring 20. The connecting portion 40 is configured to connect to the conveyor 200. The end surface 112 of the end section 11 includes a first portion end surface 1121 and a second portion end surface 1122 that are interconnected. The first portion end surface 1121 and the second portion end surface 1122 are disposed along the circumference of the graft body 10. Compared to the second portion end surface 1122, the first portion end surface 1121 protrudes away from the main section 12, i.e., outwardly. A convex region 11a is formed between the second portion end surface 1122 and the first portion end surface 1121. At least the end of the connecting portion 40 that is distal to the main section 12 is disposed within the convex region 11a, thereby positioning the convex region 11a on the conveyor 200. At this time, the surface where the second portion end surface 1122 is located is a plane.

[0076] In this embodiment, since the first corrugated ring 20 is connected to the end section 11 and is fixed relative to the end section 11, the first corrugated ring 20 and the end section 11 form a whole, and the connecting portion 40 is formed on at least one of the end section 11 and the first corrugated ring 20, that is, the connecting portion 40 is connected to the end section 11 and the first corrugated ring 20 as a whole. At this time, it is the connecting portion 40 that is connected to the conveyor 200. The conveyor 200 is connected to the end section 11 and the first corrugated ring 20 as a whole through the connecting portion 40, which can buffer the conveyor. The force exerted by the delivery device 200 on the relative displacement between the first wave coil 20 and the end segment 11 enables the relative position between the first wave coil 20 and the end segment 11 to remain unchanged, thereby ensuring that the end segment 11 and the first wave coil 20 of the coated stent 100 can better maintain their shapes after the coated stent 100 is released, so that the coated stent 100 can better fit with the inner wall of the blood vessel, ensuring the wall adhesion of the coated stent 100, thereby improving the sealing effect of the coated stent 100, avoiding internal leakage, and reducing surgical risks.

[0077] At the same time, on the basis of ensuring wall adhesion, the coated bracket 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 away from the main section 12 is arranged in the convex area 11a, so that the convex area 11a can be driven to be positioned on the anchor 203, forming a relatively close contact. Compared with the flat end face 112 of the coated stent 100, the convex area 11a is the area axially enclosed by the surface where the second part end face 1122 is located and the first part end face 1121. The remaining part of the coated stent 100 can be at least partially offset from the connecting portion 40 or the convex area 11a along the axial direction of the coated stent 100, so that the radial compression diameter of the part of the coated stent 100 connected to the anchor 203 is smaller, which facilitates the coating stent 100 to be loaded into the sheath 201 with a smaller diameter, and thus facilitates the conveyor 200 to convey the coated stent 100 to the lesion location; in addition, there are fewer parts of the coated stent 100 connected to the anchor 203, which can reduce unnecessary interference between the coated stent 100 and the anchor 203 of the conveyor 200 during assembly and / or release, improve assembly efficiency and / or release efficiency, and reduce damage to the coated stent 100 and / or conveyor 200.

[0078] Please refer to Figure 4. In some embodiments, the first wave coil 20 is located in the end section 11. At this time, the axial area A2 of the first wave coil 20 is located in the axial area A1 of the end section 11, that is, the end section 11 can completely cover the first wave coil 20, and the first wave coil 20 does not have a bare stent part exposed axially outside the coated body 10, so as to prevent the first wave coil 20 from being exposed along the axial part of the coated stent 100, causing the exposed part of the first wave coil 20 to be easily pulled by the conveyor 200, resulting in the exposed part of the first wave coil 20 to undergo incompletely reversible deformation when the coated stent 100 is compressed, thereby ensuring that the first wave coil 20 can recover and maintain its shape after release, and further ensuring that the end section 11 and the coated stent 100 can better maintain their shape after release, ensuring that the coated stent 100 has good wall adhesion, improving the sealing effect of the coated stent 100, and avoiding internal leakage. For example, at least part of the wave crest of the first wave coil 20 is flush with the end face 112 of the end segment 11; or, the wave crest of the first wave coil 20 is arranged adjacent to the end face 112 of the end segment 11, and the axial area A2 of the first wave coil 20 is located within the axial area A1 of the end segment 11, so that the open end 111 of the end segment 11 can better maintain its shape and can better fit the inner wall of the blood vessel.

[0079] In some embodiments, the surface where the second portion end face 1122 is located is a plane; or, the second portion end face 1122 is a concave curved surface or a convex curved surface. Exemplarily, if the second portion end face 1122 is a plane, the surface where the second portion end face 1122 is located is shown as ω in FIG5 , and the surface ω where the second portion end face 1122 is located is enclosed with the first portion end face 1121 (marked with a dotted line) to form a convex area 11a. Referring to FIG6 , if the second portion end face 1122 is concave relative to the first portion end face 1121, that is, the second portion end face 1122 is a concave curved surface, then the surface ρ where the cross-section of the concave curved surface is farthest from the main body segment 12 in the axial direction perpendicular to the coated stent is selected and enclosed with the first portion end face 1121 (marked with a dotted line in FIG6 ) to form a convex area 11a. 7 , the second part end face 1122 is an outward convex curved surface, and the surface ρ of the cross section of the outward convex curved surface which is farthest from the main segment 12 in the axial direction perpendicular to the coated stent is selected to enclose the first part end face 1121 (as marked by a dotted line in FIG7 ) to form an outward convex area 11a.

[0080] In some embodiments, the number of the first portion end faces 1121 and the second portion end faces 1122 can be designed according to actual needs, such as one, two, three or more. Referring to Figure 4, in some embodiments, the number of the first portion end faces 1121 includes at least two, and the plurality of first portion end faces 1121 are arranged at intervals along the circumference of the coated stent 100, and each first portion end face 1121 is correspondingly provided with at least one connecting portion 40 to improve the connection reliability between the coated stent 100 and the conveyor 200. It can be understood that the second portion end face 1122 is connected between two adjacent first portion end faces 1121. Exemplarily, the plurality of first portion end faces 1121 are arranged at equal intervals along the circumference to make the radial support performance of the end segment 11 more uniform, thereby providing a guarantee for the coated stent 100 to have good wall adhesion.

[0081] It can be understood that the connection portion 40 is formed on at least one of the end section 11 and the first wave ring 20 , including: the connection portion 40 is formed on the end section 11 or the first wave ring 20 ; the connection portion 40 is formed on the end section 11 and the first wave ring 20 .

[0082] In some embodiments, the connecting portion 40 is configured to hook and engage with the anchor 203 of the conveyor 200, making assembly and release of the connecting portion 40 and the anchor 203 simple and quick. For example, one of the anchor 203 and the connecting portion 40 may include a hook, and the other may include a hollow structure or a hole structure that engages with the hook.

[0083] Referring to FIG. 5 or FIG. 8 , in some embodiments, the connection portion 40 includes a connecting wire 41 or a connecting band 42 connected to at least one of the end segment 11 and the first corrugation 20. With this structure of the connection portion 40, the force applied by the conveyor 200 to the connection portion 40 can be relatively evenly distributed across the entire first corrugation 20 and the end segment 11, thereby ensuring that the end segment 11 and the stent graft 100 maintain their shape after release, allowing the stent graft 100 to better adhere to the inner wall of the blood vessel and ensuring the wall adhesion of the stent graft 100. For example, the connecting wire 41 or the connecting band 42 is connected to at least the first corrugation 20, allowing the force applied by the conveyor 200 to the connection portion 40 to be relatively evenly distributed across the connection points between the first corrugation 20 and the end segment 11, thereby ensuring that the end segment 11 and the stent graft 100 maintain their shape after release, thereby improving the wall adhesion of the stent graft 100. For example, the connecting line 41 is arranged at the crest of the first wave ring 20. On the basis of ensuring that the coated stent 100 has good wall adhesion, it can also make full use of the space occupied by the first wave ring 20 and the first part end face 1121, so that the coated stent 100 has a compact structure and occupies a small space. The connecting line 41 or the connecting belt 42 can be arranged on the inner wall of the end section 11, or on the outer wall of the end section 11. Exemplarily, the connecting line 41 or the connecting belt 42 is arranged on the inner wall of the end section 11. When the conveyor 200 implants the coated stent 100 into the blood vessel, it can reduce the damage caused by the connecting portion 40 to the inner wall of the blood vessel, and avoid the connecting portion 40 causing greater stimulation or damage to the inner wall of the blood vessel. Among them, the material of the connecting line 41 or the connecting belt 42 includes but is not limited to metal materials, polymer materials or metal and polymer composite materials.

[0084] In this embodiment, the connecting wire 41 or the connecting belt 42 is located within the convex region 11a. This ensures that after the connecting wire 41 or the connecting belt 42 is hooked with the anchor 203, the convex region 11a can be more accurately positioned on the anchor 203, reducing or preventing contact between the non-convex region of the stent graft 100 and the anchor 203, thereby enabling the selection of a sheath with a smaller inner diameter.

[0085] For example, the connecting line 41 may include any suitable linear or filamentary structure. The connecting belt 42 may include a strip or ribbon structure, such as a strip of film. One end of the connecting belt 42 is connected to the first corrugated ring 20 and / or the end section 11, and the other end of the connecting belt 42 is connected to the first corrugated ring 20 and / or the end section 11. The middle portion of the connecting belt 42 is used for hooking the anchor 203 of the conveyor 200.

[0086] Referring to Figure 9, in some embodiments, the connecting portion 40 includes a connecting hole 43, through which the anchor 203 of the conveyor 200 passes to secure the stent graft 100. Exemplarily, the connecting hole 43 extends through the end section 11. In this embodiment, the shape of the connecting hole 43 can be circular, square, or irregular.

[0087] It can be understood that at least the end of the connecting hole 43 away from the main section 12 is arranged in the convex area 11a, including: case 1, the connecting hole 43 is arranged in the convex area 11a; case 2, the end of the connecting hole 43 away from the main section 12 is arranged in the convex area 11a, and the end close to the main section 12 is arranged in other areas of the end section 11 except the convex area 11a.

[0088] Since the position where the anchor 203 is hooked is the end of the connecting hole 43 away from the main section 12 , the end of the connecting hole 43 close to the main section 12 can be set anywhere in the end section 11 .

[0089] Referring to Figures 2, 9, and 10, in some embodiments, the connecting portion 40 includes a first end C1 distal from the main body segment 12 and a second end C2 proximal to the main body segment 12. The first end C1 is closer to the axis m of the stent graft 100 than the second end C2, so that the connecting portion 40 has a certain inclination angle, making it easier for the anchor 203 of the conveyor 200 to be released 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 stent graft 100; or the first end C1 of the connecting portion 40 may be further away from the axis m of the stent graft 100 than the second end C2.

[0090] Referring to Figures 9 and 10, illustratively, the connecting portion 40 includes a connecting hole 43, the hole wall of the connecting hole 43 having a first end C1 (i.e., the proximal end of the hole wall of the connecting hole 43) and a second end C2 (i.e., the distal end of the hole wall of the connecting hole 43), wherein the angle α between the straight line on which the first end C1 and the second end C2 of the connecting hole 43 lie and the axis m of the stent graft 100 is an acute angle, and the first end C1 of the hole wall of the connecting hole 43 is closer to the axis m of the stent graft 100 than the second end C2 of the hole wall of the connecting hole 43, so that the connecting hole 43 has a certain inclination angle, making it easier for the anchor 203 of the conveyor 200 to be released from the connecting hole 43. In other embodiments, the angle α between the straight line on which the first end C1 and the second end C2 of the connecting hole 43 lie and the axis m of the stent graft 100 may not be an acute angle, for example, the straight line on which the first end C1 and the second end C2 of the connecting hole 43 lie is parallel to the axis m of the stent graft 100.

[0091] In FIG11 , illustratively, the connection portion 40 includes a connection seam 44, which is formed on the end section 11. Specifically, the connection seam 44 is drawn on the end section 11, and the connection seam 44 runs through the end section 11. The anchor 203 of the conveyor 200 fixes the stent graft 100 by passing through the connection seam 44. In this embodiment, the shape of the connection seam 44 can be a straight line, a U-shape, a V-shape, a W-shape, etc. Among them, the U-shape, the V-shape, the W-shape, etc. are the connection seams 44 with an open end 441. The open end 441 of the connection seam 44 is close to the main section 12, so as to facilitate the anchor 203 of the conveyor 200 to be hooked from the end of the connection seam 44 away from the main section 12. It can be understood that since the connecting seam 44 with the open end 441 shape can be opened to form a larger opening, the connecting seam 44 with the open end 441 shape is easier for the anchor 203 of the conveyor 200 to extend into the connecting seam 44 for hooking than the straight connecting seam 44.

[0092] 12 and 13 , the connection portion exemplarily includes a connecting membrane 45 , with a portion of the first corrugated ring 20 disposed between the end segment 11 and the connecting membrane 45 . An insertion port 450 is provided between the end segment 11 and the connecting membrane 45 . The insertion port 450 is used to insert the anchor 203 of the conveyor 200 to achieve connection. In this embodiment, the connecting membrane 45 and the end segment 11 are integrally structured, that is, the connecting membrane 45 extends from the membrane body 10 . Specifically, the membrane body 10 extends toward the open end 111 , folds inward at the end surface 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 segment 11 by sutures 451 , and the insertion port 450 is formed at a position of the connecting membrane 45 away from the open end 111 . In another embodiment, the connecting film 45 and the end section 11 are not integrally formed, but are formed as a separate piece of film. The connecting film 45 can be connected to at least one of the end section 11 or the first corrugated ring 20 by suturing or gluing. In one embodiment, the connecting film 45 can be made of a material having a developing function, which can be used to indicate the position of the open end 111 of the stent graft 100. Specifically, a developing element can be connected to the connecting film 45, or the connecting film 45 can be immersed in a developing solution.

[0093] Referring to Figure 14 , in some embodiments, the stent graft 100 further includes a second wave ring 51, which is connected to the end segment 11. The connecting portion 40 includes a connecting hole 43, and one of the wave crests of the second wave ring 51 is positioned adjacent to the connecting hole 43. Thus, during the assembly and release of the stent graft 100, the second wave ring 51 can better support the graft body 10 around the connecting hole 43, preventing deformation of the connecting hole 43 that could prevent the connecting portion 40 or the end segment 11 from being released from the anchor 203 of the conveyor 200. It is understood that one of the wave crests of the first wave ring 20 can also be positioned adjacent to the connecting seam 44.

[0094] Referring to FIG. 14 , in some embodiments, one of the wave crests of the first wave coil 20 is positioned adjacent to the connection hole 43. Along the axial direction of the stent graft 100, the connection hole 43 is positioned between one of the wave crests of the first wave coil 20 and one of the wave crests of the second wave coil 51. Thus, during assembly and release of the stent graft 100, both the first wave coil 20 and the second wave coil 51 can effectively support the graft body 10 around the connection hole 43, effectively preventing the connection portion 40 or the end segment 11 from being released from the anchor 203 of the conveyor 200 due to deformation of the connection hole 43. Exemplarily, one of the wave crests of the first wave coil 20, the connection hole 43, and one of the wave crests of the second wave coil 51 are positioned sequentially along the axial direction of the stent graft 100, with one of the wave crests of the first wave coil 20 being closer to the end surface 112 of the end segment 11 than one of the wave crests of the second wave coil 51. In other embodiments, the second wave ring 51 may intersect with or not intersect with the first wave ring 20 , and the wave crest of the second wave ring 51 has a certain circumferential distance from the connecting hole 43 .

[0095] In some embodiments, the first corrugation 20 comprises a wavy ring-shaped structure formed by a first support wire. The first corrugation 20 is elastically deformable and may be partially or entirely made of an elastic material. For example, the first corrugation 20 may be made of a material with excellent tensile and resilient properties and good biocompatibility, such as nickel-titanium or stainless steel. Because the first corrugation 20 has excellent tensile and resilient properties, it possesses an inherent elastic force to restore its deformation. The elastic deformability of the first corrugation 20 increases the radial anchoring force of the graft body 10 and improves the stability of the stent graft 100 during use. In other embodiments, the first corrugation 20 may be made of a non-elastic material. For example, adjacent corrugated rods in a first corrugation 20 made of a non-elastic material may be rotatably connected by a pivot member. In this case, the first corrugation 20 does not possess its own elastic force, and its deformation is driven by the self-expanding graft body 10 and / or other corrugations of the stent graft 100.

[0096] Referring to FIG. 15 , in some embodiments, the first wave loop 20 includes a first wave segment 21. In some implementations, the first wave segment 21 includes at least one first wave 21a. For example, the first wave segment 21 includes a first wave bar 211 and a second wave bar 212. Adjacent first wave bars 211 and second wave bars 212 are connected to a common first wave crest 213 to form the first wave 21a.

[0097] Exemplarily, the position of the first waveform segment 21 or the first wave 21 a is coaxially arranged with the position of the first partial end surface 1121 , so that the first waveform segment 21 or the first wave 21 a can support the first partial end surface 1121 .

[0098] Referring to Figure 15 , 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 bar 221 and a fourth wave bar 222, with adjacent third wave bars 221 and fourth wave bars 222 connected to the same second wave crest 223 to form the second wave 22a.

[0099] Exemplarily, the position of the second waveform segment 22 or the second wave 22 a is coaxially arranged with the position of the second portion end surface 1122 , so that the second waveform segment 22 or the second wave 22 a can support the second portion end surface 1122 .

[0100] For example, the first partial end surface 1121, the crest of the first wave 21a, and at least a portion of the connecting portion 40 are sequentially arranged along the axial direction of the stent graft 100, resulting in a compact structure of the stent graft 100 and good wall adhesion of the end segment 11. In other embodiments, the first wave ring 20 may also intersect with the end surface 112 of the end segment 11.

[0101] Please refer to Figure 15. In some embodiments, the crest of the first wave 21a is located in the convex area 11a, so that the first wave 21a can effectively support the convex area 11a. For example, the first wave 21a is located in the end section 11 to prevent the first wave 21a from being at least partially exposed outside the end section 11, and the first wave 21a is connected to the end section 11 and relatively fixed to the end section 11, so that the first wave 21a is always not separated from the end section 11, avoiding the problem that the first wave 21a is easily pulled by the conveyor 200 and the first wave 21a undergoes incomplete reversible deformation when the coated support 100 is compressed, thereby ensuring that the first wave 21a and the end section 11 can recover after release. And maintain its shape, thereby ensuring that the stent graft 100 has good wall adhesion, improving the sealing effect of the stent graft 100, and avoiding internal leakage; compared with the first wave 21a at least partially exposed axially outside the end section 11, the axial area of ​​the first wave 21a of this embodiment is located in the axial area of ​​the end section 11, which can reduce the collision or friction between the first wave ring 20 and the conveyor 200, thereby reducing the situation where the stent graft 100 is prone to unnecessary interference with the conveyor 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, so as to effectively support the convex area 11a of the coating body 10 and the end of the stent graft 100, so that the stent graft 100 has better wall adhesion and is not prone to bleeding after the stent graft 100 is implanted in the blood vessel.

[0102] Exemplarily, the second wave 22a is located inside the end section 11, preventing the second wave 22a from being at least partially exposed outside the end section 11, causing the exposed part of the second wave 22a to be easily pulled by the conveyor 200, resulting in the exposed part of the second wave 22a undergoing incompletely reversible deformation when the coated support 100 is compressed, thereby ensuring that the second wave 22a can recover and maintain its shape after release, and further ensuring that the end section 11 and the coated support 100 can better maintain their shape after release, ensuring that the coated support 100 has good wall adhesion, improving the sealing effect of the coated support 100, and avoiding internal leakage. For example, the crest of the second wave 22a is arranged adjacent to the second part end face 1122, or the crest of the second wave 22a is located at the second part end face 1122, so that the second wave 22a can effectively support the second part end face 1122 of the coating body 10 and the end of the coating stent 100, so that the coating stent 100 has better wall adhesion and is not easy to leak blood after the coating stent 100 is implanted in the blood vessel.

[0103] It can be understood that the wire diameter, wave height, wave number and wave angle of the first wave coil 20 can be set according to actual needs. For example, the wire diameter of the first wave coil 20 ranges 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 ranges 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 ranges from 3 to 30, such as 3, 6, 10, 20, 30 or any other suitable value between 3 and 30. The more the wave number of the wave coil, the greater the radial support force on the end of the coated stent 100, which can effectively improve the wall adhesion effect of the end of the coated stent 100.

[0104] Referring to FIG. 15 , in some embodiments, the first corrugated ring 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. The region where the end segment 11 of the stent graft 100 is located is the first region 100a. It is understood that the first region 100a includes the end segment 11 and the corrugated ring provided on the end segment 11.

[0105] Understandably, after the stent graft 100 is released from the delivery device 200, the first wave coil 20 rebounds under its own elastic force, driving the first region 100a into contact with the inner wall of the blood vessel. 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 causes uneven circumferential release of the first region 100a, resulting in uneven circumferential force exerted by the first region 100a on the inner wall of the blood vessel. This can easily lead to concentrated force within the vessel, potentially impacting or damaging the vessel during release, causing discomfort to the patient or even vasospasm. Furthermore, this uneven circumferential release of the first region 100a can affect the post-compression morphology of the stent graft 100, resulting in insufficient wall adhesion of the first region 100a, which can easily cause endoleaks and increase surgical risks. To this end, referring to FIG16 , in some embodiments, the stent graft 100 further includes a balancing structure 50 disposed within the first region 100a. The balancing structure 50 is configured to increase the radial support strength of a region of the first region 100a coaxial with the first corrugated 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.

[0106] The coated stent 100 of the above embodiment includes a balancing structure 50 connected to the end segment 11, and the balancing structure 50 is used to increase the radial support strength of the area 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 area in the first region 100a that is coaxial with the first waveform segment 21 and the area in the first region 100a that is coaxial with the second waveform segment 22, thereby reducing the difference between the release speeds of the area in the first region 100a that is coaxial with the first waveform segment 21 and the area in the first region 100a that is coaxial with the second waveform segment 22, thereby making the circumferential release of the first region 100a and the coated stent 100 more uniform, making the circumferential force of the first region 100a and the coated stent 100 on the inner wall of the blood vessel more uniform, reducing the occurrence of the phenomenon of more concentrated force on the inner wall of the blood vessel, and reducing the irritation and damage to the blood vessel during the release process. In addition, the first region 100a is released uniformly in the circumferential direction, so that the end segment 11 or the first region 100a can better maintain its shape after the coated stent 100 is compressed and released, so that the first region 100a and the coated stent 100 have good wall adhesion, avoiding internal leakage and reducing surgical risks.

[0107] In some embodiments, the radial support strength of the first wave 21a is less than the radial support strength of the second wave 22a. Exemplarily, 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, so that the radial support strength of the first wave 21a is less than the radial support strength of the second wave 22a. Exemplarily, when the axial region of the first wave ring 20 is located within the axial region of the end section 11, 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 enables the first wave 21a to better support the first portion end surface 1121 and makes the radial support strength of the first wave 21a less than the radial support strength of the second wave 22a. When the first wave ring 20 is at least partially exposed axially outside the axial region of the end section 11, 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 makes it easier and more convenient for the first wave 21a to connect to the anchor 203 of the conveyor 200, and the radial support strength of the first wave 21a is less than that of the second wave 22a. In other embodiments, the wave height of the first wave 21a can be less than or equal to the wave height of the second wave 22a. The wave angle of the first wave 21a can also be greater than or less than the wave angle of the second wave 22a.

[0108] In other embodiments, the radial support strength of the first wave segment 21 is greater than or equal to the radial support strength of the second wave 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.

[0109] Referring to Figures 16 and 17, in some embodiments, the balancing structure 50 includes a second wave ring 51, which is connected to the end segment 11. The second wave ring 51 is used to increase the radial support strength of the area in the first region 100a coaxial with the first wave segment 21, thereby balancing the radial support strength of the area in the first region 100a coaxial with the first wave segment 21 and the area in the first region 100a coaxial with the second wave segment 22, reducing the difference between the release speeds of the area in the first region 100a coaxial with the first wave segment 21 and the area in the first region 100a coaxial with the second wave segment 22, thereby making the first region 100a and the coated stent 100 more uniform in the circumferential direction. In addition, the second wave ring 51 can also play a role in strengthening the support of the end segment 11, ensuring that the first region 100a can adhere well to the wall after release, avoiding the problem of the first region 100a forming a bird's beak shape and causing bleeding. In other embodiments, the balancing structure 50 is not necessarily a corrugated coil structure, but may be a separate component, such as a mesh or a block made of metal or plastic.

[0110] 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 first region 100a coaxially with the first corrugated section 21. For example, the first corrugated ring 20 and the balancing structure 50 are spaced apart along the axial direction of the stent graft 100 to avoid the balancing structure 50 interfering with the connection and release of the first corrugated ring 20 and the conveyor 200.

[0111] In some embodiments, the second wave coil 51 may intersect with the first wave coil 20, as shown in FIG15 ; and / or the wave crest of the second wave coil 51 may intersect with the end surface 112 of the open end portion 111, as shown in FIG3 ; and / or the second wave coil 51 is located within the end segment 11. In some embodiments, referring to FIG15 and FIG17 , the proximal end of the second wave coil 51 or the proximal end of the balancing structure 50 may be disposed adjacent to the end surface 112 of the end segment 11, specifically adjacent to the second portion end surface 1122, so that the second wave coil 51 or at least a portion of the balancing structure 50 can support the end surface 112 of the end segment 11 to a certain extent, so that the end surface 112 of the end segment 11 can maintain a good shape after the stent graft 100 is compressed and released, thereby making the stent graft 100 more adherent and less prone to bleeding.

[0112] Referring to FIG. 18 , in some embodiments, at least two of the end surface 112 of the end segment 11, the first wave ring 20, and the second wave ring 51 are spaced apart in the axial direction. For example, the end surface 112 of the end segment 11, the first wave ring 20, and the second wave ring 51 are spaced apart in the axial direction of the stent graft 100, thereby facilitating the processing of the stent graft 100.

[0113] In some embodiments, the axial region of the second wave ring 51 at least partially overlaps with the axial region of the first wave ring 20, so that the axial distance between the second wave ring 51 and the first wave ring 20 is reduced, which can increase the radial support strength at the proximal end of the coated stent 100, and enhance the radial support force of the first region 100a, thereby increasing the anchoring of the proximal end of the coated stent 100 in the blood vessel, thereby making the proximal end of the coated stent 100 less likely to shift, improving the sealing performance of the coated stent 100, and making the structure of the coated stent 100 more compact.

[0114] Referring to FIG. 18 , in some embodiments, the second wave coil 51 is connected to the end section 11 and is located within the end section 11. For example, at least a portion of the wave crests of the second wave coil 51 are flush with the end surface 112 of the end section 11; alternatively, the wave crests of the second wave coil 51 are spaced a certain distance from the end surface 112 of the end section 11, with the end surface 112 of the end section 11 being located proximal to the wave crests of the second wave coil 51. Exemplarily, as shown in the figure, the second wave coil 51 is located within the end section 11, and the wave crests of the first wave section 21 and one of the wave crests of the second wave coil 51 are spaced apart along the axial direction of the stent graft 100.

[0115] Please refer to Figure 18. In some embodiments, the second wave ring 51 includes a third wave 511 and a fourth wave 512. The radial support strength of the third wave 511 is less than the radial support strength 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, so that the second wave ring 51 can balance the circumferential support strength of the first area 100a, so that the first area 100a is released more evenly in the circumferential direction, and thereby the circumferential force exerted by the first area 100a and the coated stent 100 on the inner wall of the blood vessel is more uniform.

[0116] Exemplarily, at least one third wave 511 may be disposed between two adjacent fourth waves 512 , and at least one fourth wave 512 may be disposed between two adjacent third waves 511 .

[0117] 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 smaller than the radial support strength of the fourth wave 512. In other embodiments, the wave height of the third wave 511 may be smaller than or greater than the wave height of the fourth wave 512, and the wave angle of the third wave 511 may be greater than or equal to the wave angle of the fourth wave 512. This is not a limitation herein, as long as the radial support strength of the third wave 511 is smaller than the radial support strength of the fourth wave 512.

[0118] For example, the first waveform segment 21 includes a first wave 21a, and the second waveform segment 22 includes a second wave 22a. The first wave 21a has a greater height than the second wave 22a, and the angle of the first wave 21a is equal to the angle of the second wave 22a. The third wave 511 has a height equal to the fourth wave 512, and the angle of the third wave 511 is less than the angle of the fourth wave 512. This allows the second wave ring 51 to effectively balance the radial support strength of the area of ​​the first region 100a coaxial with the first waveform segment 21 and the area of ​​the first region 100a coaxial with the second waveform segment 22, thereby reducing the difference in release speed between the area of ​​the first region 100a coaxial with the first waveform segment 21 and the area of ​​the first region 100a coaxial with the second waveform segment 22, thereby achieving more uniform release in the circumferential direction of the first region 100a. Furthermore, both the first wave ring 20 and the second wave ring 51 can reinforce the support of the end segment 11, effectively ensuring that the first region 100a adheres well to the wall after release.

[0119] 18 , illustratively, the third wave 511 includes a fifth wave bar 5111 and a sixth wave bar 5112, where adjacent fifth wave bars 5111 and sixth wave bars 5112 are connected to a same third wave peak 5113 to form the third wave 511. The fourth wave 512 includes a seventh wave bar 5121 and an eighth wave bar 5122, where adjacent seventh wave bars 5121 and eighth wave bars 5122 are connected to a same fourth wave peak 5123 to form the fourth wave 512.

[0120] Exemplarily, the third wave 511 includes a straight line, a broken line, or a curved line. For example, referring to FIG18 , the third wave 511 and / or the fourth wave 512 include a straight line. For another example, referring to FIG19 , the third wave 511 and / or the fourth wave 512 include a broken line. The third wave 511, with its curved wave bars, can be extended more easily without interfering with other waves, thereby making it easier to support the end surface 112 of the end segment 11 to a certain extent, thereby further enabling the end surface 112 of the end segment 11 to maintain a good shape after the stent graft 100 is compressed and released.

[0121] For example, the number of wave peaks of the first wave coil 20 and the number of wave peaks of the second wave coil 51 can be the same or different, and this is not limited here. The number of first waves 21a and third waves 511 can be the same or different; the number of second waves 22a and fourth waves 512 can be the same or different.

[0122] Referring to FIG. 19 , in some embodiments, the balancing structure 50 further includes a third wave ring 52 connected to the end segment 11. The third wave ring 52 is configured to increase the radial support strength of the region of the first region 100a coaxial with the first wave segment 21, thereby balancing the radial support strength of the region of the first region 100a coaxial with the first wave segment 21 and the region of the first region 100a coaxial with the second wave segment 22. This reduces the difference in release rate between the region of the first region 100a coaxial with the first wave segment 21 and the region of the first region 100a coaxial with the second wave segment 22, thereby achieving more uniform circumferential release of the first region 100a and the stent graft 100. Furthermore, the third wave ring 52 reinforces the support of the end segment 11, ensuring that the first region 100a adheres well to the wall after release, thus preventing the first region 100a from forming a bird's beak shape and causing bleeding. In this embodiment, the third wave ring 52 is also annular and partially overlaps with the second wave ring 51.

[0123] Referring to Figure 19 , in some embodiments, the second wave coil 51 is used to form a closed structure 53, which is coaxially arranged with the first wave segment 21. It is understandable that since the second and third wave coils 51, 52 are both fixed to the graft body 10, the closed structure 53 is also fixed to the graft body 10. In particular, the apex of the closed structure 53 is fixed. When the stent graft 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 graft portion enclosed by the closed structure 53 is simultaneously pulled axially proximally and distally. When the graft portion in the closed structure 53 is pulled to its limit, the closed structure 53 is difficult to be further radially compressed. Therefore, the graft portion enclosed by the closed structure 53 hinders the radial compression of the closed structure 53, making the closed structure 53 less susceptible to radial compression. Therefore, the radial support strength of the closed structure 53 is greater than that of a non-enclosed structure.

[0124] Please refer to Figure 19. In some embodiments, the third wave ring 52 intersects and cooperates with the second wave ring 51 to form a closed structure 53, thereby further increasing the radial support strength of the area in the first region 100a that is coaxial with the first waveform segment 21, and making the first region 100a release more uniformly in the circumferential direction as much as possible.

[0125] Please refer to Figure 19. 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 arranged at intervals along the axial direction of the coated stent 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.

[0126] Please refer to Figure 19. 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 supporting 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 coated stent 100, and further improve the circumferential release uniformity of the first region 100a and the coated stent 100.

[0127] For example, the heights of the waves in the third wave loop 52 may be the same, different, or partially the same, which is not limited here.

[0128] Referring to FIG. 19 , in some embodiments, the wave height of the third wave coil 52 is less than the wave height of the second wave coil 51 , and the axial region of the third wave coil 52 is located within the axial region of the second wave coil 51 . Thus, the balancing structure 50 can not only balance the circumferential radial support strength of the stent graft 100, but also facilitate achieving a more compact structure of the stent graft 100 . Furthermore, the axial distance between the third wave coil 52 and the second wave coil 51 is reduced, which can increase the radial support strength at the proximal end of the stent graft 100 , thereby increasing the anchoring of the proximal end of the stent graft 100 in the blood vessel, making the stent graft 100 less likely to shift within the blood vessel. For example, the distal end (at least a portion of the trough) of the third wave coil 52 is flush with the distal end (at least a portion of the trough) of the second wave coil 51 .

[0129] In some embodiments, the number of wave peaks in the third wave ring 52 is greater than or equal to the number of wave peaks in the second wave ring 51, so as to improve the radial 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 stent graft 100. For example, the number of wave peaks in the third wave ring 52 is equal to twice the number of wave peaks in the second wave ring 51. In other embodiments, the number of wave peaks in the third wave ring 52 can also be less than the number of wave peaks in the second wave ring 51.

[0130] Illustratively, the crest of the third wave coil 52 is farther away from the end surface 112 of the end section 11 than the crest of the second wave coil 51 , so that the connection between the second wave coil 51 and the third wave coil 52 and the end section 11 is convenient, simple and easy.

[0131] It can be understood that at least part of the wave crest of the third wave coil 52 can be set at any appropriate position. For example, at least part of the wave crest of the third wave coil 52 is located on at least one of the fifth wave rod 5111, the sixth wave rod 5112, the seventh wave rod 5121, and the eighth wave rod 5122. For another example, the wave crest of the third wave coil 52 can be located at at least one of the following positions: between the fifth wave rod 5111 and the sixth wave rod 5112; between the sixth wave rod 5112 and the seventh wave rod 5121; between the seventh wave rod 5121 and the eighth wave rod 5122; and between the eighth wave rod 5122 and the fifth wave rod 5111.

[0132] Exemplarily, the axial region of the third wave ring 52 is located within the axial region of the end segment 11, and the axial region of the third wave ring 52 is located within the axial region of the second wave ring 51, so as to better increase the radial support strength of the region in the first region 100a that is coaxial with the first waveform segment 21, so that the circumferential force of the first region 100a on the inner wall of the blood vessel is more uniform, reducing or avoiding the phenomenon of concentrated force on the inner wall of the blood vessel, thereby reducing or avoiding damage to the blood vessel; in addition, it can also enable the end segment 11 to be released more evenly, ensuring that the end segment 11 can better maintain its shape after release, so that the end segment 11 can better fit with the inner wall of the blood vessel, improve the wall adhesion of the end segment 11 of the coated stent 100, and thus avoid internal leakage.

[0133] The shape of the closed structure 53 can be set according to actual needs, for example, including at least one of the following: a quadrilateral, a pentagon, a hexagon, other polygons, other irregular closed shapes, etc. For example, referring to FIG19 , the shape of the closed structure 53 includes a quadrilateral or a rhombus. For another example, referring to FIG20 , the shape of the closed structure 53 includes a hexagon.

[0134] In one embodiment, the balancing structure 50 includes at least one of the following: a second wave ring 51, a third wave ring 52, a fourth wave ring 54, and other wave rings. Referring to FIG. 21 , illustratively, the balancing structure 50 includes the second wave ring 51, the third wave ring 52, and the fourth wave ring 54, which 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 coaxial with the first wave segment 21 in the first region 100a. When the radial support strength of the circumferentially different wave segments of the first wave ring 20 is too large, or the overall radial support strength of the proximal end of the stent graft 100 is too low, a balancing structure 50 including multiple wave rings can be provided at the corresponding location to maximize the radial support strength of the proximal end of the stent graft 100 (or the first region 100a) and achieve more uniform circumferential release of the proximal end of the stent graft 100. Furthermore, each wave coil of the balancing structure 50 can also provide support for the end section 11, ensuring that the first region 100a can adhere well to the wall after release, thereby preventing the end of the stent graft 100 from forming a bird's beak shape and causing bleeding. For example, the second wave coil 51, the third wave coil 52, and the fourth wave coil 54 are all continuous wave structures.

[0135] It can be understood that the wire diameter, wave height, wave number and / or wave angle of the second wave coil 51, the third wave coil 52 and the fourth wave coil 54 can be set according to actual needs and are not limited here.

[0136] In some embodiments, the wire diameter of the third wave coil 52 is smaller than the wire diameter of the second wave coil 51. The function of the third wave coil 52 is to supplement the radial support of the second wave coil 52. However, the radial support strength of the third wave coil 52 should not be too large, otherwise it will easily cause the first area 100a to stimulate the blood vessels or even rupture the blood vessels.

[0137] Referring to Figure 22 , in some embodiments, at least one first intersection 61 is present in the first region 100a within a region coaxial with the first wave segment 21. This first intersection 61 is formed by the intersection of the first wave segment 21 and the balancing structure 50, or by the balancing structure 50 itself. This can increase the radial support strength of the first region 100a and provide more uniform axial release in the first region 100. Referring to Figure 22 , in some implementations, the first intersection 61 is formed by the intersection of at least two of the second, third, and fourth wave loops 51, 52, and 54 of the balancing structure 50. For example, the number of the first intersection points 61 includes six, which are respectively recorded as intersection point D1, intersection point D2, intersection point D3, intersection point D4, intersection point D5, and intersection point D6. The third wave loop 52 and the fourth wave loop 54 intersect in the area coaxial with the first waveform segment 21 to form intersection point D1 and intersection point D2. The second wave loop 51, the third wave loop 52 and the fourth wave loop 54 intersect in the area coaxial with the first waveform segment 21 to form intersection point D3 and intersection point D4. The second wave loop 51 and the third wave loop 52 intersect in the area coaxial with the first waveform segment 21 to form intersection point D3 and intersection point D4. The intersection D5 and the intersection D6 are formed in the area coaxial with the first waveform segment 21. In this way, the combination of the third wave ring 52 and the fourth wave ring 54, the combination of the second wave ring 51, the third wave ring 52 and the fourth wave ring 54, and the combination of the second wave ring 51 and the third wave ring 52 can respectively resist the radial extrusion force as a whole, thereby further improving the radial support force, improving the wall adhesion of the first area 100a and the proximal end of the coated stent 100, and avoiding the problem of bleeding.

[0138] In some embodiments, intersections D1 and D2 are symmetrically arranged about a first predetermined straight line, intersections D3 and D4 are symmetrically arranged about the first predetermined straight line, and intersections D5 and D6 are symmetrically arranged about the first predetermined straight line. This provides more uniform radial support performance in first region 100a, thereby improving the wall adherence of first region 100a and stent graft 100. For example, the first predetermined straight line passes through the crest of first wave 21a and the crest of the region of second wave loop 51 that is coaxial with first wave 21a. For example, the first predetermined straight line is represented by dashed line n1 in FIG. 22 .

[0139] Please refer to Figure 22. In some embodiments, in the first area 100a, there are multiple second intersections 62 in the area coaxial with the second waveform segment 22, and the number of first intersections 61 is greater than the number of second intersections 62, wherein the second intersection 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 intersections 61 is greater than the number of second intersections 62, which is beneficial for the balancing structure 50 to better balance the radial support strength of the area in the first region 100a that is coaxial with the first waveform segment 21 and the area in the first region 100a that is coaxial with the second waveform segment 22, effectively reducing the difference between the release speeds of the area in the first region 100a that is coaxial with the first waveform segment 21 and the area in the first region 100a that is coaxial with the second waveform segment 22, thereby making the first region 100a and the coated stent 100 release more uniformly in the circumferential direction, making the circumferential force of the first region 100a and the coated stent 100 on the inner wall of the blood vessel more uniform, reducing the occurrence of more concentrated force on the inner wall of the blood vessel, reducing stimulation and damage to the blood vessel during the release process, and also helping the end segment 11 or the first region 100a to better maintain its shape after the coated stent 100 is compressed and released, so that the first region 100a and the coated stent 100 have good wall adhesion.

[0140] Referring to FIG. 22 , in some embodiments, the second intersection 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 intersections 62 includes two, respectively denoted as intersection H1 and intersection H2. 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 H1 and intersection 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 enhancing radial support force, improving the wall adhesion of the first region 100a and the proximal end of the coated stent 100, and avoiding bleeding problems.

[0141] In some embodiments, intersection H1 and intersection H2 are symmetrically arranged about a second predetermined straight line, thereby providing more uniform radial support performance in first region 100a and improving the wall adherence of first region 100a and stent graft 100. For example, the second predetermined straight line passes through the crest of second wave 22a and the crest of the region coaxial with second wave 22a within second wave loop 51. For example, the second predetermined straight line is shown as dashed line n2 in FIG. 22 .

[0142] Exemplarily, the stent graft 100 can be prepared by weaving a metal wire into the desired waveform. The metal wire can be a nickel-titanium alloy wire with a wire 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 secure them by mechanical compression, thereby fastening the metal wire and the steel sleeve to form a metal ring. After the waveform ring structure is completed, the surface of the multiple-turn waveform ring structure arranged in sequence is coated with a film. For example, the inner and outer surfaces of the multiple-turn waveform ring structure can be entirely coated with an e□PTFE film, with the multiple-turn waveform ring structure located between the two layers of film. The inner and outer layers of the e□PTFE film are bonded together by high temperature and pressure, thereby securing the multiple-turn waveform ring structure between the two layers of film. Of course, when the waveform ring structure is formed by cutting a metal tube as a whole, it does not need to be fixed with a steel sleeve. Alternatively, the inner or outer surface of the multiple-turn waveform ring structure can be entirely coated with an e□PTFE film.

[0143] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "mechanically coupled", and "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium. It can be the internal connection of two elements or the interaction relationship between two elements. The mechanical coupling or coupling of two components includes direct coupling and indirect coupling, for example, direct fixed connection, connection through a transmission mechanism, etc. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0144] In this application, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0145] The disclosure above provides many different embodiments or examples for realizing the different structures of the present application. In order to simplify the disclosure of the present application, the components and settings of specific examples are described above. Of course, they are merely examples and are not intended to limit the present application. In addition, the present application may repeat reference numerals and / or reference letters in different examples, and such repetition is for the purpose of simplicity and clarity, and does not itself indicate the relationship between the various embodiments and / or settings discussed. In addition, the present application provides examples of various specific processes and materials, but those of ordinary skill in the art will appreciate the application of other processes and / or the use of other materials.

[0146] Throughout this specification, reference to terms such as "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples" means that the specific method steps, features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representations 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 any one or more embodiments or examples.

[0147] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application 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 application, and such modifications or substitutions should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

Claims

1. A stent graft, characterized in that: include: A covering body including an end section having an open end; A first wave ring is connected to the end section; the first wave ring includes a first waveform section and a second waveform section, the radial support strength of the first waveform section is less than the radial support strength of the second waveform section, and the region where the end section on the stent graft is located is the first region; The balancing structure is arranged in the first region and is used to increase the radial support strength of a region in the first region that is coaxial with the first waveform segment.

2. The stent graft according to claim 1, characterized in that: The balancing structure includes a second convolution connected to the end segment.

3. The stent graft according to claim 2, characterized in that: An axial region of the second wave ring at least partially overlaps an axial region of the first wave ring.

4. The stent graft according to claim 2, characterized in that: The second wave ring includes a third wave and a fourth wave, the radial support strength of the third wave is smaller than the radial support strength of the fourth wave, the fourth wave is coaxially arranged with the first waveform segment, and the third wave is coaxially arranged with the second waveform segment.

5. The stent graft according to claim 4, characterized in that: The first waveform segment includes a first wave, the second waveform segment includes a second wave, the wave height of the first wave is greater than the wave height of the second wave, the wave angle of the first wave is equal to the wave angle of the second wave, the wave height of the third wave is equal to the wave height of the fourth wave, and the wave angle of the third wave is greater than the wave angle of the fourth wave.

6. The stent graft according to claim 2, characterized in that: The second wave ring is used to form a closed structure, and the closed structure is coaxially arranged with the first wave segment.

7. The stent graft according to claim 6, characterized in that: The balancing structure further includes a third wave ring connected to the end section, wherein the third wave ring intersects and cooperates with the second wave ring to form the closed structure.

8. The stent graft according to claim 7, characterized in that: The wire diameter of the third wave coil is smaller than the wire diameter of the second wave coil.

9. The stent graft according to claim 1, characterized in that: In the first region, there is at least one first intersection point in a region coaxial with the first wave segment, wherein the first intersection point is formed by the intersection of the first wave segment and the balancing structure or by the balancing structure itself.

10. The stent graft according to claim 9, characterized in that: In the first region, there are multiple second intersections in the region coaxial with the second waveform segment, and the number of the first intersections is greater than the number of the second intersections, wherein the second intersections are formed by the intersection of the second waveform segment and the balancing structure or by the balancing structure itself.

11. The stent graft according to any one of claims 1 to 10, characterized in that: The balancing structure is at least partially disposed on the end surface of the coating body or adjacent to the end surface of the coating body, and is used to support the end surface of the coating body.

12. A conveying system, characterized in that: include: conveyor; as well as The coated stent as described in any one of claims 1-11, wherein the conveyor is used to convey the coated stent.

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