Stent graft

Abstract

The present invention discloses a stent graft, comprising a plurality of coils, wherein the plurality of coils are arranged in an axial direction; a membrane, wherein the membrane is arranged on the plurality of coils, wherein the membrane and the plurality of coils form a hollow tubular structure with openings at both ends, wherein the membrane is woven from wires; and a restraining member, wherein the restraining member is provided at the edge of at least one open end of the hollow tubular structure, wherein the end of the membrane is covered by the restraining member, thereby restraining the wires at the end of the membrane. According to the stent graft of the present application, by providing a restraining member at the opening of at least one end of the hollow tube formed by the membrane and the plurality of coils, the end of the membrane is covered by the restraining member, thereby restraining the wires at the end of the membrane, thereby effectively preventing the trimmed wires at the edge of the membrane from extending through the pores of the restraining member, preventing the burr fibers at the edge of the membrane from irritating and damaging the blood vessels at the implantation site, and reducing unnecessary damage to the patient.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical equipment, and in particular relates to a stent graft. Background Art

[0002] The coating material in existing coated stents is generally PTFE or PET. PET coating is usually woven from yarn. Due to the particularity of its structure, during the stent coating process, the PET coating needs to be cut into the required length and shape, and then the stent coil is fixedly connected to the PET coating. The cut PET coating is prone to burrs on the cut edges. After a stent with burrs is implanted in a human blood vessel, it is easy to stimulate inflammation in the human blood vessels, causing the proliferation of inflammatory cells, thereby reducing the inner lumen of the stent and affecting the blood flow in the stent. In addition, the burr structure is unstable and is easily affected by the impact of blood flow, causing the yarn fibers to fall off. The shed yarn fibers will follow the blood flow into the blood vessels of the lower limbs, posing a risk of blockage of the lower limb blood vessels. Summary of the Invention

[0003] The object of the present invention is to at least solve the problem of burrs on the edges of the coating. This object is achieved by:

[0004] The present invention provides a coated stent, comprising: a plurality of coils, wherein the plurality of coils are arranged along an axial direction; a coating, wherein the coating is arranged on the plurality of coils, and the coating and the plurality of coils form a hollow tubular structure with openings at both ends, and the coating is woven from wire; a restraining piece, wherein the restraining piece is provided on the edge of at least one open end of the hollow tubular structure, and the end of the coating is covered by the restraining piece, thereby restraining the wire at the end of the coating.

[0005] In one embodiment, the restraint includes a first section and a second section connected to the first section, the first section is connected to the inner surface of the covering, and the second section is connected to the outer surface of the covering.

[0006] In one embodiment, the width dimension of the first section is less than or equal to the width dimension of the wave coil close to the proximal end of the stent graft.

[0007] In one embodiment, the width dimension of the second segment is greater than the width dimension of the first segment.

[0008] In one embodiment, the restraining member includes a plurality of restraining units, which are spaced apart at at least one end opening of the hollow tubular structure, and the spacing between any two adjacent restraining units is smaller than the wire diameter of the coated wire.

[0009] In one embodiment, the edge of the first segment is configured to be serrated, zigzag, or wavy.

[0010] In one embodiment, the restraint comprises a ribbon, and the ribbon is sutured around at least one end opening of the hollow tubular structure to form a suture knot.

[0011] In one embodiment, the strip is provided by unilateral suturing or cross-stitching, and the suturing knot is provided on the outer surface of the covering.

[0012] In one embodiment, the stent graft further comprises a suture thread, and the suture thread is used to suture and fix the suture knot.

[0013] In one embodiment, the restraining member and the coating are an integrated structure, and the coating includes a coating body, a first section and a second section. The coating body is arranged on the plurality of wave rings and forms the hollow tube with open ends together with the plurality of wave rings. The first section, the second section and the coating body are connected in sequence, and the first section and the second section form the restraining member. The first section is arranged between the coating body and the second section.

[0014] In one embodiment, the first section is sandwiched between the outer surface of the covering body and the second section, and a width dimension of the first section is smaller than a width dimension of the second section.

[0015] According to the coated stent of the present application, a restraint is provided at the opening of at least one end of the hollow tubular structure formed by the coating and a plurality of coils, so that the end of the coating is covered by the restraint, thereby restraining the wire at the end of the coating, thereby effectively preventing the cut edge wire of the coating from extending through the pores of the restraint, preventing the burr fibers at the edge of the coating from irritating and damaging the blood vessels at the implantation site, and reducing unnecessary damage to the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiment below. The accompanying drawings are for illustration purposes only and are not to be considered as limiting the present invention. The same reference numerals are used throughout the accompanying drawings to denote the same components.

[0017] Figure 1 is a schematic structural diagram of a first embodiment of the stent graft of the present invention, including a restraining member;

[0018] Figure 2 for Figure 1 A schematic diagram of the structure of the middle restraining member before folding;

[0019] Figure 3 for Figure 2 A schematic diagram of the structure of the restraining member after folding;

[0020] Figure 4 Schematic diagram of the structure of the second embodiment of the stent graft of the present invention;

[0021] Figure 5 for Figure 4 Schematic diagram of the structure of the middle binding unit before folding;

[0022] Figure 6 for Figure 5 A schematic structural diagram of the binding unit during the folding process shown;

[0023] Figure 7 for Figure 4 A schematic structural diagram of another example of a binding unit;

[0024] Figure 8 for Figure 7 A schematic structural diagram of the binding unit during the folding process shown;

[0025] Figure 9 Schematic diagram of the structure of a third embodiment of the stent graft of the present invention;

[0026] Figure 10 for Figure 9 Schematic diagram of the end structure of the middle covered stent;

[0027] Figure 11 for Figure 9 A schematic diagram of the end structure of another example of a stent graft;

[0028] Figure 12 for Figure 9 A schematic diagram of the end structure of another example of a stent graft;

[0029] Figure 13 Schematic diagram of the structure of a fourth embodiment of the stent graft of the present invention;

[0030] Figure 14 for Figure 13 Schematic diagram of the end structure of the middle coating;

[0031] Figure 15 for Figure 14 The schematic structural diagram of the end folding process of the coating is shown.

[0032] The symbols in the accompanying drawings represent the following:

[0033] 100: stent graft;

[0034] 10: wave circle;

[0035] 20: coating, 21: coating body, 22: first section, 23: second section;

[0036] 30: restraint, 31: first section, 32: second section, 33: fold line, 34: strap, 36: suture line;

[0037] 40: Binding unit. DETAILED DESCRIPTION

[0038] Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. Rather, these embodiments are provided to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0039] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain" and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the specific order described or illustrated, unless the order of execution is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0040] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0041] For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside," "outside," "inside," "outside," "below," "beneath," "above," and the like. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "beneath" another element or feature would then be oriented as "above" or "above" the other element or feature. Thus, the example term "below" can include both above and below orientations. The device may be oriented otherwise (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein should be interpreted accordingly.

[0042] To more clearly describe the structure of the suturing device, the terms "proximal" and "distal" are defined here as commonly used in the field of interventional medicine. Specifically, the direction of blood inflow is defined as "proximal," and the direction of blood outflow is defined as "distal." That is, blood flows into the proximal end of the stent graft, passes through the stent graft, and then outflows from the distal end of the stent graft. "Axial" refers to the longitudinal direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0043] Implementation Method 1

[0044] Combine Figures 1 to 3 As shown, the stent graft 100 of this embodiment includes multiple corrugations 10, a membrane 20, and a restraining member 30. The multiple corrugations 10 are arranged axially, forming a framework for supporting the membrane 20. The membrane 20 is disposed on the multiple corrugations 10, forming a hollow tubular structure with open ends. The restraining member 30 is provided at at least one open edge of the hollow tubular structure. The ends of the membrane 20 are covered by the restraining member 30, and the pore size of the restraining member 30 is smaller than the wire diameter of the membrane 20. The corrugations 10 are metal corrugations, providing good support and deformability. The membrane 20 is woven from wire. In this embodiment, the membrane 20 is a PET membrane woven from yarn. The restraining member 30 can be made of PET, PTFE, or other biocompatible materials. For example, a sheet woven from PET can be subjected to high-pressure densification to form a high-density, low-porosity sheet or tube. The restraint 30 can be directly put on the end of the membrane 20 and combined with the end of the membrane 20 by sewing or other means.

[0045] According to the coated stent 100 of the present application, a restraint 30 is provided at the opening of at least one end of the hollow tube formed by the coating 20 and a plurality of coils 10, and the end of the coating 20 is accommodated inside the restraint 30, and the pore size of the restraint 30 is smaller than the wire diameter of the wire of the coating 20, so that the wire at the end of the coating can be restrained, and the edge wire of the cut coating 20 is effectively prevented from extending through the pore of the restraint 30, and the burr fibers at the edge of the coating 20 are prevented from irritating and damaging the blood vessels at the implantation site or even falling off and entering the blood, thereby reducing unnecessary damage to the patient and improving the patient's recovery speed.

[0046] Combine Figure 2 and Figure 3 As shown, the restraint 30 of this embodiment is a closed annular structure comprising a first section 31 and a second section 32. The first section 31 is connected to the inner surface of the stent graft 20, and the second section 32 is connected to the outer surface of the stent graft 20. Thus, the first section 31 and the second section 32 work together to enclose the end of the stent graft 20. The pore size of the restraint 30 is smaller than the diameter of the wires of the stent graft 20, effectively preventing the edge wires of the trimmed stent graft 20 from protruding through the pores of the restraint 30, thus preventing the edge fibers of the stent graft 20 from irritating and damaging blood vessels at the implant site. In this embodiment, the restraint 30 is only shown as being provided at one end of the stent graft 100. In other examples of this embodiment, the restraint 30 may be provided at the other end of the stent graft 100, or at both ends of the stent graft 100. The first section 31 and the second section 32 may be formed by folding the restraint 30 inward or outward along a fold line 33. The inner diameter of the restraint 30 before folding is roughly equal to the outer diameter of the coating 20, thereby ensuring that when the restraint 30 is assembled with the coating after folding, the restraint 30 can match the coating 20, and will not affect the size of the coating stent or only constrain the edge burrs of the coating 20 due to the radial size of the restraint 30 being too large or too small.

[0047] In this embodiment, the width dimension of the restraint 30 before folding is b1, and the folding line 33 divides the restraint 30 into a first section 31 and a second section 32. The width dimension of the second section 32 is b0, and the width dimension of the first section 31 is b0'. The width direction in this embodiment is the axial direction of the stent graft 100. The width dimension b0 of the second section 32 and the width dimension b0' of the first section 31 may be equal or unequal. Preferably, the width dimension b0 of the second section 32 is greater than the width dimension b0' of the first section 31, so as to minimize the influence of the restraint 30 on the inner diameter of the end of the stent graft 100, while increasing the contact area between the restraint 30 on the outer side of the end of the stent graft 100 and the blood vessel, thereby reducing the stress of the end wave ring 10 on the blood vessel. Furthermore, the width dimension b0 of the second section 32 should satisfy: 0<b0≤30 mm. As a result, the outer side of the stent graft 100 can have sufficient area to fully adhere to the blood vessel at the implantation site, ensuring the sealing of the stent graft 100 while reducing stress concentration on the blood vessel and lowering the probability of reverse tearing of a dissecting aneurysm. The width dimension b0' of the first segment 31 should satisfy the following: 0 < b0' ≤ the height of the corrugations 10 of the stent graft 100 near the proximal end. This ensures that the restraint 30 effectively restrains the edge burrs of the stent graft 20 while not affecting the inner diameter of the stent graft 100, ensuring smooth blood flow within the lumen of the stent graft 100.

[0048] It can be understood that in other embodiments, the width dimension of the first section of the restraint provided at the distal end of the coated stent can be greater than the width dimension of the second section. Since the second section is provided on the outer surface of the distal end of the coated stent, at this time, in order to reduce the difficulty of assembling the stent, the width dimension of the second section can be appropriately reduced. Therefore, the width dimension of the second section can also be smaller than the above-mentioned anchoring length, and of course it can also be smaller than the width dimension of the first section.

[0049] It can be understood that in other embodiments, the edge of the first section 31 in contact with the inner surface of the coating 20 can also be set to a serrated, Z-shaped or wavy shape consistent with the wave ring, but its width should be smaller than the height of the wave ring 10, so as to prevent the first section 31 from overlapping with the wave ring 32, thereby avoiding causing the inner cavity size of the coated stent 100 to decrease and affecting the blood flow.

[0050] The restraint 30 provided on the stent graft 100 not only restrains the edge burrs of the stent graft 100's coating 20, preventing burr fibers from irritating and damaging the blood vessels at the implant site, but also increases the edge thickness of the stent graft 100's coating 20, particularly the outer thickness of the coating 20. Because the edges of the stent graft 100's coating 20 are located at the proximal and distal ends of the stent graft 100, these areas must closely align with the implanted blood vessels to ensure the sealing of the stent graft 100. Therefore, the increased thickness of the coating 20 allows the proximal and / or distal ends of the stent graft 100 to more closely align with the implanted blood vessels, effectively reducing the probability of endoleaks. Furthermore, when the stent graft 100 is used to treat a dissecting aneurysm, the increased outer thickness of the stent graft 100 allows the second section 32 of the restraint 30 to act as a buffer, reducing the stress exerted by the proximal end of the implanted stent graft 100 on the blood vessels and reducing the probability of reverse tearing due to stress concentration at the ends of the stent graft 100.

[0051] It can be understood that the design in this embodiment in which the width of the restraint located on the outside of the membrane is larger than the width on the inside of the membrane is also applicable to the coated stent whose membrane is made of polymer material. At this time, the function of the restraint is to reduce the stress on the blood vessel from the outside of the end of the coated stent.

[0052] Implementation Method 2

[0053] Combine Figures 4 to 6 As shown, the stent graft 100 of this embodiment comprises multiple corrugations 10, a membrane 20, and a restraining member 30. The corrugations 10 are arranged axially, forming a framework for supporting the membrane 20. The membrane 20 is mounted on the corrugations 10, forming a hollow tubular structure with open ends. The restraining member 30 is located at the edge of at least one open end of the hollow tubular structure. The end of the membrane 20 is enclosed by the restraining member 30, and the pore size of the restraining member 30 is smaller than the diameter of the wire of the membrane 20. The restraining member 30 of this embodiment comprises multiple restraining units 40, spaced apart at at least one open end of the hollow tubular structure. The spacing b2 between any two adjacent restraining units 40 is smaller than the diameter of the wire of the membrane 20. The corrugations 10 are metal, providing good support and deformability. The membrane 20 is woven from wire; in this embodiment, the membrane 20 is a PET membrane woven from yarn. The restraining unit 40 can be made of PET, PTFE, or other biocompatible materials. For example, a sheet woven from PET can be subjected to high-pressure densification to form a high-density, low-porosity sheet. The restraining unit 40 can be directly placed over the end of the membrane 20 and joined to the membrane 20 by suturing or other means.

[0054] Therefore, it should be understood that when the present application describes the restraint covering the end of the coating, it does not mean that the restraint completely covers without gaps. There may be gaps on the restraint, but the gaps meet the above requirements as long as they can restrain the ends of the coated wire.

[0055] According to the coated stent 100 of the present application, a plurality of binding units 40 are arranged at the opening of at least one end of the hollow tube formed by the coating 20 and a plurality of wave coils 10, the pore size of the binding unit 40 is smaller than the wire diameter of the coating 20, and the plurality of binding units 40 are arranged in a ring at the opening of at least one end of the hollow tubular structure, and the spacing size between any two adjacent binding units 40 is smaller than the wire diameter of the coating 20, so that the end of the coating 20 is accommodated in the space surrounded by the plurality of binding units 40, so that the wire at the end of the coating can be bound, effectively avoiding the edge wire of the cut coating 20 from extending through the pores of the binding unit 40 or between two adjacent binding units 40, preventing the edge burr fibers of the coating 20 from irritating and damaging the blood vessels at the implantation site or even falling off and entering the blood, thereby reducing unnecessary damage to the patient and improving the patient's recovery speed.

[0056] Combine Figure 5 and Figure 6 As shown, the restraint 30 of this embodiment includes a plurality of restraint units 40 that are spaced apart from each other and arranged in a ring around at least one end as shown. Any restraint unit 40 includes a first section 31 and a second section 32. The first section 31 is connected to the inner surface of the coating 20, and the second section 32 is connected to the outer surface of the coating 20, so that the end of the coating 20 is wrapped by the joint action of the first section 31 and the second section 32, and the pore size of the restraint unit 40 is smaller than the wire diameter of the coating 20, and the spacing dimension b2 between any two adjacent restraint units 40 is smaller than the wire diameter of the coating 20, so that the edge wire of the cut coating 20 can be effectively prevented from extending through the pores of the restraint unit 40 or between two adjacent restraint units 40, thereby preventing the edge burr fibers of the coating 20 from irritating and damaging the blood vessels at the implantation site. In this embodiment, the arrangement of multiple restraining units 40 at one end of the stent graft 100 is merely illustrative. In other examples of this embodiment, multiple restraining units 40 may be arranged at the other end of the stent graft 100, or multiple restraining units 40 may be arranged at both ends of the stent graft 100. The first section 31 and the second section 32 may be formed by folding the restraining units 40 inwardly or outwardly along the folding line 33.

[0057] In this embodiment, the fold line 33 divides the restraining unit 40 into a first section 31 and a second section 32. The width of the second section 32 may or may not be equal to that of the first section 31. Preferably, the width of the second section 32 is greater than that of the first section 31. This minimizes the effect of the restraining unit 40 on the inner diameter of the end of the stent graft 100, increases the contact area between the restraining unit 40 and the blood vessel at the outer end of the stent graft 100, and reduces the stress exerted on the blood vessel by the end corrugation 10.

[0058] Furthermore, the width of the second segment 32 should be less than or equal to the anchoring length of the stent graft 100 (typically 10-30 mm), and the width of the first segment 31 should be less than or equal to the height of the corrugation 10 of the stent graft 100. This ensures that the restraining unit 40 effectively restrains the edge burrs of the stent graft 100 while not affecting the inner diameter of the stent graft 100, thereby ensuring smooth blood flow within the lumen of the stent graft 100. This allows sufficient area on the outside of the stent graft 100 to fully conform to the blood vessel at the implantation site, ensuring a tight seal and minimizing stress concentration on the vessel, thereby reducing the probability of reverse tearing of a dissecting aneurysm. Furthermore, the spacing of the multiple restraining units prevents the formation of minor wrinkles caused by the difference in inner and outer diameters when the closed annular structure is folded.

[0059] In other examples of this embodiment, a plurality of restraining units 40 may be continuously fitted together to form a restraining member 30 and effectively restrain the edge burrs of the coating 20 of the stent graft 100 .

[0060] Recombination Figure 7 and Figure 8 As shown, in other examples of this embodiment, the first section 31 in contact with the inner surface of the coating 20 can also be set to a serrated, Z-shaped or wavy shape consistent with the wave ring, but its width should be smaller than the height of the wave ring 10, so as to prevent the first section 31 from overlapping with the wave ring 32, thereby avoiding causing the inner cavity size of the coated stent 100 to be reduced and affecting the passage of blood flow.

[0061] Implementation Method 3

[0062] Combine Figure 9 and Figure 10 As shown, the stent graft 100 of this embodiment includes a plurality of corrugations 10, a coating 20, and a restraining member 30. The plurality of corrugations 10 are arranged in the axial direction to form a skeleton for supporting the coating 20. The coating 20 is arranged on the plurality of corrugations 10, and the coating 20 and the plurality of corrugations 10 form a hollow tubular structure with both ends open. The restraining member 30 is provided at the edge of at least one end of the opening of the hollow tubular structure. The end of the coating 20 is covered by the restraining member 30, and the pore size of the restraining member 30 is smaller than the wire diameter of the coating 20.

[0063] According to the coated stent 100 of the present application, a strip 34 is provided at the opening of at least one end of the hollow tubular structure formed by the coating 20 and a plurality of coils 10. The strip 34 is sutured around the edge of the opening of the end of the coating to form a suture knot, thereby binding the wire at the end of the coating. This can effectively prevent the edge wire of the cut coating 20 from extending out, prevent the edge burr fibers of the coating 20 from irritating and damaging the blood vessels at the implantation site, reduce unnecessary damage to the patient, and improve the patient's recovery speed.

[0064] Combine Figure 9 and Figure 10 As shown, the restraint 30 of this embodiment includes a strip 34, which is formed by suturing and winding around the end of the stent graft 20. The material of the strip 34 can be PET, PTFE or other materials with good biocompatibility. For example, a sheet woven from PET is subjected to high-pressure densification treatment to form a high-density, low-porosity sheet or wire. In this embodiment, only the restraint 30 is exemplarily provided at one end of the stent graft 100. In other examples of this embodiment, the restraint 30 can be provided at the other end of the stent graft 100, or the restraint 30 can be provided at both ends of the stent graft 100.

[0065] In this embodiment, the strip 34 is attached to the outer surface of the graft 20 using a single-sided knotting method (i.e., a suture knot is tied on the outside of the graft 20 for each stitch). This minimizes the effect of the restraint 30 on the inner diameter of the end of the stent graft 100, while increasing the contact area between the restraint 30 and the blood vessel at the outer end of the stent graft 100, thereby reducing the stress exerted by the end corrugation 10 on the blood vessel. Furthermore, the spacing between any two adjacent suture knots is b3, which is smaller than the wire diameter of the graft 20. This prevents the edge wire of the graft 20 from protruding between adjacent suture knots after trimming.

[0066] like Figure 11 As shown, in other examples of this embodiment, the strip 34 can also be cross-stitched to the outer surface of the coating 20 (that is, the strip is sutured in one direction and then sutured in the opposite direction to form a cross-stitch knot), thereby further increasing the contact area between the restraint 30 and the blood vessel and reducing the stress of the end wave ring 10 on the blood vessel.

[0067] like Figure 12As shown, in another example of this embodiment, to more tightly couple the strip 34 to the edge of the stent graft 20, the strip 34 can be sutured near the port, with suture thread 36 securing the intersection of the strip 34 (i.e., the suture knot). Since the sutured strip 34 is constrained by the suture thread 36, the strip 34 will not shift due to circumferential forces during the assembly and release of the stent graft 100, ensuring the effective placement of the strip 34.

[0068] The restraining member 30 in this embodiment is disposed at the proximal and / or distal ends of the stent graft 100. The proximal and distal ends of the stent graft typically adhere to a human blood vessel, forming an anchoring zone. Because the restraining member 30 in this embodiment has a relatively rough surface, when adhered to a human blood vessel, it increases friction between the stent graft 100 and the vessel, making the stent graft 100 less susceptible to displacement due to blood flow impact, thereby improving the stent graft 100's anti-displacement performance.

[0069] Implementation Method 4

[0070] Combine Figures 13 to 15 As shown, the stent graft 100 of this embodiment includes a plurality of coils 10, a coating 20 and a restraining member 30. The plurality of coils 10 are arranged in the axial direction to form a skeleton for supporting the coating 20. The coating 20 is arranged on the plurality of coils 10, and the coating 20 and the plurality of coils 10 form a hollow tubular structure with both ends open. The edge of at least one end of the hollow tubular structure is provided with a restraining member 30. The end of the coating 20 is covered by the restraining member 30, and the pore size of the restraining member 30 is smaller than the wire diameter of the coating 20. The restraining member 30 of this embodiment is an integral structure with the coating 20. The coating 20 includes a coating body 21, a first section 22 and a second section 23. The coating body 21 is arranged on the plurality of coils 10 and is arranged on the inner side of the plurality of coils, forming a hollow tubular structure with both ends open with the plurality of coils 10. The first section 22 , the second section 23 and the covering body 21 are sequentially connected. The first section 22 and the second section 23 form a restraining member 30 . The first section 22 is sandwiched between the covering body 21 and the second section 23 .

[0071] The restraining member 30 of this embodiment is formed by folding the end of the coating 20 outward twice continuously. Figure 14 and Figure 15As shown, the restraint 30 of this embodiment is made from a blank covering reserved when the covering 20 on the stent graft 100 is manufactured. First, the reserved blank covering needs to be divided into a first section 22 and a second section 23 by a folding line 33. The first section 22 is formed by a first outward folding, and then the first section 22 formed by the first folding is wrapped around the second outward folding to form the second section 23. Finally, the second section 23 is fixed to the covering 20 of the stent graft 100 by sutures or other connection methods. The width of the first section 22 is L0, and the width of the second section 23 is L1. The width L0 of the first section 22 is smaller than the width L1 of the second section 23, so that the edge of the first section 22 is wrapped between the second section 23 and the outer surface of the covering 20, which can restrain the wire at the end of the covering, effectively preventing the edge wire of the cut covering 20 from protruding through the pores of the second section 23, and preventing the edge fibers of the covering 20 from irritating and damaging the blood vessels at the implantation site. In this embodiment, the restraint 30 is only exemplarily provided at one end of the coated stent 100. In other examples of this embodiment, the restraint 30 may be provided at the other end of the coated stent 100, or the restraint 30 may be provided at both ends of the coated stent 100.

[0072] The restraining member 30 of this embodiment is integrally formed with the stent graft 20 on the stent graft 100. Furthermore, the outward-flapping design does not reduce the inner diameter of the stent graft 100, thereby ensuring smooth blood flow within the inner cavity of the stent graft 100. Furthermore, the outward-flapping design improves the wall adhesion of the anchoring region of the stent graft 100. The soft coating material can adapt to more complex vascular anatomy and increases the contact area between the outer surface of the stent graft 100 and the blood vessel, thereby reducing the probability of endoleakage within the stent graft 100.

[0073] In other examples of this embodiment, the restraint 30 can also be set on the inner surface of the coating 20, and the coating body is set on the outside of the wave ring. Similarly, when the coating 20 on the coated stent 100 is made, a blank coating is reserved, and then the reserved blank coating is divided into a first section 22 and a second section 23 through a folding line 33. The first section 22 is formed by the first inward folding, and the first section 22 formed for the first time is wrapped by the second inward folding to form the second section 23. Finally, the second section 23 is fixed to the inner surface of the coating 20 of the coated stent 100 by sutures or other connection methods. It can also effectively constrain the end of the coating 20, avoid the edge wire of the cut coating 20 from extending through the pores of the second section 23, and prevent the edge burr fibers of the coating 20 from irritating and damaging the blood vessels at the implantation site.

[0074] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes, substitutions, or combinations that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A stent graft, characterized in that: include: A plurality of corrugations, wherein the plurality of corrugations are arranged along an axial direction; A covering film, the covering film being arranged on the plurality of the corrugated rings, the covering film and the plurality of the corrugated rings forming a hollow tubular structure with both ends open, the covering film being a PET covering film woven from wires; A restraining piece, wherein the restraining piece and the coating are split structures and connected, the restraining piece is provided on the opening edge of at least one end of the hollow tubular structure, and the end of the coating is covered by the restraining piece, thereby restraining the wire at the end of the coating, wherein the pore size of the restraining piece is smaller than the wire diameter size of the wire of the coating.

2. The stent graft according to claim 1, wherein: The restraint includes a first section and a second section connected to the first section, the first section is connected to the inner surface of the covering membrane, and the second section is connected to the outer surface of the covering membrane.

3. The stent graft according to claim 2, wherein: The width of the first section is smaller than or equal to the width of the wave coil close to the proximal end of the stent graft.

4. The stent graft according to claim 2, wherein: The width dimension of the second segment is greater than the width dimension of the first segment.

5. The stent graft according to claim 1, wherein: The restraining member includes a plurality of restraining units, which are spaced apart at at least one end opening of the hollow tubular structure, and the spacing between any two adjacent restraining units is smaller than the wire diameter of the coated wire.

6. The stent graft according to any one of claims 2 to 5, characterized in that: The edge of the first section is configured to be serrated, Z-shaped or wavy.

7. The stent graft according to claim 1, wherein: The binding member includes a belt-shaped body, and the belt-shaped body is sutured around at least one end opening of the hollow tubular structure to form a suture knot.

8. The stent graft according to claim 7, wherein: The strip-shaped body is arranged by unilateral suturing or cross-stitching, and the suturing knot is arranged on the outer surface of the covering membrane.

9. The stent graft according to claim 7, characterized in that: The stent graft further includes a suture thread, which is used to suture and fix the suture knot.

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