Vascular covered stent, manufacturing method thereof and covered stent delivery system

Abstract

The application provides a blood vessel covered stent, which comprises a tubular inner layer film and at least one supporting structure, the supporting structure comprises a supporting body and at least one connecting film, the supporting body is arranged around the outer surface of the inner layer film, the supporting body is provided with a through hole, the connecting film passes through the through hole and is arranged around the inner layer film, and the connecting film is connected with the inner layer film. The blood vessel covered stent is small in diameter and is convenient to place in a blood vessel. The application further provides a manufacturing method of the blood vessel covered stent and a covered stent conveying system.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to a vascular covered stent, its manufacturing method, and a covered stent delivery system. Background Technology

[0002] With the improvement of people's living standards, significant changes have occurred in dietary structure and lifestyle, leading to an increasing incidence of vascular diseases. Common vascular diseases include aneurysms, vascular perforation, vascular rupture, aortic dissection, atherosclerosis, and vascular embolism. To avoid the high risks during and after traditional surgery, vascular stents have become the most widely used minimally invasive interventional medical device. Interventional surgery has advantages such as small incisions, less pain, and faster recovery. Supported by modern medical angiography technology, vascular stents are inserted into the narrowed segment of the blood vessel through guidewire expansion or balloon dilation, using the principle of self-expansion to a certain diameter or balloon dilation. This achieves the goals of supporting the narrowed or occluded segment of the blood vessel, reducing vascular retraction, maintaining unobstructed blood flow in the vascular cavity, and reshaping the vessel.

[0003] Covered stents are stents with a special membrane material covering the surface of a metal stent. They possess both the functions of traditional vascular stents and the properties of membrane materials, thus enabling their application in many areas where ordinary vascular stents cannot address the problem. For example, in emergencies such as vascular perforation or rupture, covered stents can effectively control bleeding. When the lesion site has severely insufficient vascular elasticity, or when there is severe calcification, diffuse thrombosis, or even complete occlusion, using ordinary vascular stents may lead to serious risks such as vascular tearing, aortic dissection, thrombus dislodgement, or thrombus migration, requiring subsequent remedial surgery. However, using covered stents for dilation, with the stent used for lumen shaping and the membrane material blocking blood flow, covered stents can safely treat these types of lesions. Furthermore, from a clinical perspective, the primary patency rate and target lesion reconstruction rate of covered stents are significantly higher than those of bare stents.

[0004] Existing covered stents consist of an inner membrane, an outer membrane, and a supporting framework connecting the inner and outer membranes. Because the outer membrane covers the outer surface of the supporting framework, the overall diameter of the covered stent is relatively large, which is not conducive to its placement in blood vessels; moreover, the existing covered stents are difficult to manufacture and costly. Summary of the Invention

[0005] To address the aforementioned deficiencies in the prior art, this application aims to provide a vascular covered stent with a small diameter, which facilitates placement in blood vessels.

[0006] This application provides a vascular covered stent, including a tubular inner membrane and at least one support structure. The support structure includes a support body and at least one connecting membrane. The support body surrounds the outer surface of the inner membrane and has a through hole. The connecting membrane passes through the through hole and surrounds the inner membrane, and is connected to the inner membrane.

[0007] Optionally, the support body is in the form of a wave-shaped bend; the support body includes multiple support units and multiple first bending segments, the multiple support units are arranged at intervals around the axis of the inner membrane, two adjacent support units are connected by a first bending segment, each support unit is provided with a through hole, and the connecting membrane passes through the through holes of the multiple support units.

[0008] Optionally, each of the support units includes a second curved section and two connecting sections. The two ends of the second curved section are respectively connected to the two connecting sections, and the ends of the two connecting sections away from the second curved section are respectively connected to the two first curved sections. The through hole penetrates a local section of the connecting section.

[0009] Optionally, the connecting segment includes a first segment, a second segment, and a third segment, the second segment being connected between the first segment and the third segment, the first segment being connected to the first curved segment, the third segment being connected to the second curved segment, and the through hole being disposed in the second segment.

[0010] Optionally, the connecting segment includes a first surface and a second surface disposed opposite to each other, the first surface being close to the outer surface of the inner membrane, the through hole being located between the first surface and the second surface, and the height of the through hole along a direction perpendicular to the first surface and the second surface being less than or equal to 1 / 2 of the perpendicular distance between the first surface and the second surface.

[0011] Optionally, the length of the through hole along the length direction of the connecting segment is 1 / 2 to 2 / 3 of the length of the connecting segment.

[0012] Optionally, the support body is provided with a plurality of through holes, the plurality of through holes are arranged at intervals along the axial direction of the inner membrane, and the support structure includes a plurality of connecting membranes, the plurality of connecting membranes passing through the plurality of through holes and surrounding the inner membrane.

[0013] Optionally, the vascular stent graft includes a plurality of the support structures, which are arranged at intervals along the axial direction of the inner membrane.

[0014] Optionally, the support structure is formed by a plurality of support units and a first curved section connecting two adjacent support units; the number of support units in at least one support structure differs from the number of support units in the other support structures; and / or,

[0015] The spacing between at least two adjacent support structures is different from the spacing between other adjacent support structures.

[0016] Optionally, the vascular stent graft further includes multiple connectors, with adjacent support structures connected by at least one connector; the connectors are in the form of straight strips, waves, sawtooth shapes, square waves, wavy lines, or Ω shapes.

[0017] This application also provides a method for manufacturing the above-mentioned vascular covered stent, the method comprising:

[0018] The inner membrane and the connecting membrane are provided, and the inner membrane and the connecting membrane are surface treated.

[0019] A core rod is provided, and the inner layer membrane is fitted onto the core rod;

[0020] Provide the support body, insert the connecting membrane through the through hole of the support body and surround the support body once; fit the support body with the connecting membrane onto the outer surface of the inner membrane;

[0021] A pressurizing device is provided, which is used to wrap the outer surface of the support.

[0022] A heating box is provided, and the above-mentioned combined structure is placed in the heating box for heating treatment; after heating for a set time, the combined structure is taken out, and the pressurizing device and the mandrel are removed to form the vascular covered stent.

[0023] This application also provides a covered stent delivery system for delivering the aforementioned vascular covered stent into a blood vessel. The covered stent delivery system includes a connector, a guidewire, a fluid guide, a balloon, and a contrast ring. The connector has a guidewire lumen and a fluid guide. The guidewire and the fluid guide are both connected to the connector. The guidewire communicates with the guidewire lumen, and the fluid guide communicates with the fluid guide cavity. The guidewire passes through the fluid guide, and one end of the guidewire extends from the end of the fluid guide. One end of the balloon is connected to the guidewire, and the other end of the balloon is connected to the fluid guide. The fluid guide communicates with the balloon. The contrast ring is connected to the guidewire, and the vascular covered stent is mounted on the balloon.

[0024] The vascular stent graft of this application has a through hole in its support body, through which the connecting membrane can pass and wrap around the support body. This avoids the problem of increasing the overall outer diameter of the vascular stent graft caused by placing the connecting membrane on the outer surface of the support body. Therefore, the vascular stent graft of this application has a smaller diameter, which makes it easier to place in the blood vessel. Moreover, the entire stent is more tightly integrated, making the vascular stent graft more flexible overall. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure of the vascular covered stent according to the first embodiment of this application.

[0026] Figure 2a This is a schematic diagram of the structure of the support body according to the first embodiment of this application.

[0027] Figure 2b This is a side view of the connecting segment of this application.

[0028] Figure 3 This is a schematic diagram of the structure of the vascular covered stent according to the second embodiment of this application.

[0029] Figure 4 This is a schematic diagram of the structure of the support body according to the second embodiment of this application.

[0030] Figure 5 This is a schematic diagram of the connector structure according to the third embodiment of this application.

[0031] Figure 6 This is a schematic diagram of the connector structure according to the fourth embodiment of this application.

[0032] Figure 7 This is a schematic diagram of the connector structure according to the fifth embodiment of this application.

[0033] Figure 8 This is a schematic diagram of the connector structure according to the sixth embodiment of this application.

[0034] Figure 9 This is a schematic diagram of the structure of the film-coated stent delivery system according to the eighth embodiment of this application. Detailed Implementation

[0035] The following specific embodiments illustrate the implementation of this application. Those skilled in the art can easily understand other advantages and effects of this application from the content disclosed in this specification.

[0036] In the following description, reference is made to the accompanying drawings, which illustrate several embodiments of the present application. It should be understood that other embodiments may also be used, and changes in mechanical composition, structure, electrical and operational aspects may be made without departing from the spirit and scope of the present application. The following detailed description should not be considered limiting, and the terminology used herein is for describing particular embodiments only and is not intended to limit the present application.

[0037] Although the terms first, second, etc., are used in some instances to describe various elements herein, these elements should not be limited by these terms. These terms are only used to distinguish one element from another.

[0038] Furthermore, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context indicates otherwise. It should be further understood that the terms “comprising,” “including,” indicate the presence of a feature, step, operation, element, component, item, kind, and / or group, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups. The terms “or” and “and / or” as used herein are interpreted as inclusive, or mean any one or any combination thereof. Thus, “A, B, or C” or “A, B, and / or C” means “any one of: A; B; C; A and B; A and C; B and C; A, B, and C.” Exceptions to this definition arise only when combinations of elements, functions, steps, or operations are inherently mutually exclusive in some way.

[0039] First Embodiment

[0040] Figure 1 This is a schematic diagram of the structure of the vascular covered stent according to the first embodiment of this application. Figure 2a This is a schematic diagram of the structure of the support body according to the first embodiment of this application, as shown below. Figure 1 and Figure 2a As shown, the vascular endothelial stent 10 includes a tubular inner membrane 11 and at least one support structure 12. The support structure 12 includes a support body 13 and at least one connecting membrane 14. The support body 13 surrounds the outer surface of the inner membrane 11 and has a through-hole 101. The connecting membrane 14 passes through the through-hole 101 and surrounds the inner membrane 11, and is connected to the inner membrane 11. In this embodiment, the connecting membrane 14 and the inner membrane 11 can be tightly bonded together by heating or adhesive bonding, thereby forming a vascular endothelial stent 10 that can be used for vascular reshaping by the support body 13, the connecting membrane 14, and the inner membrane 11.

[0041] The vascular stent graft 10 of this application has a through hole 101 in the support body 13. The connecting membrane 14 can pass through the through hole 101 and surround the support body 13. This avoids the problem of increasing the overall outer diameter of the vascular stent graft 10 caused by placing the connecting membrane 14 on the outer surface of the support body 13. Therefore, the outer diameter of the vascular stent graft 10 of this application is smaller, which makes it easier to place in the blood vessel. Moreover, the entire stent is more tightly connected, making the vascular stent graft 10 more flexible overall.

[0042] Optionally, the inner membrane 11 and / or the connecting membrane 14 are made of an elastic material, such as polytetrafluoroethylene, expanded polytetrafluoroethylene (ePTFE), polyester fiber, silicone, polyurethane, or other thermoplastic elastomer materials.

[0043] Optionally, the support 13 has expansion and contraction functions; the support 13 is made of a superelastic material such as nickel-titanium through laser cutting, chemical etching, or 3D printing, or it can be made of materials such as cobalt-chromium alloy, stainless steel, magnesium alloy, aluminum alloy, PLA, etc., through laser cutting, chemical etching, or 3D printing. In this embodiment, the vascular graft 10 requires a small outer diameter to enter the blood vessel, and a larger outer diameter to reach the target lesion site for operation; the function of diameter change is reflected by the change of the support 13.

[0044] Optionally, the support body 13 is a tubular structure with its ends connected, and the support body 13 is wavy and curved. The support body 13 includes multiple support units 131 and multiple first bending segments 134. The multiple support units 131 are arranged at intervals around the axis of the inner membrane 11. Adjacent support units 131 are connected by a first bending segment 134. Each support unit 131 has a through hole 101, and the connecting membrane 14 passes through the through holes 101 of the multiple support units 131. The expansion and contraction of the diameter of the support body 13 are ultimately achieved by increasing and decreasing the angle of the support units 131. In this embodiment, the connecting membrane 14 passes through the through holes 101 of each support unit 131, that is, the connecting membrane 14 connects multiple support units 131 in series, and the connecting membrane 14 is connected end to end to form a ring.

[0045] Optionally, two adjacent support units 131 are smoothly connected to a first curved section 134. For example, the outer surface of the support unit 131 and the outer surface of the first curved section 134 are on the same horizontal plane, and the inner surface of the support unit 131 and the inner surface of the first curved section 134 are on the same horizontal plane. Alternatively, the support unit 131 and the first curved section 134 are connected by a circular arc structure, but this is not a limitation.

[0046] Optionally, the first curved section 134 is semi-circular, and the outer arc diameter of the first curved section 134 is 0.07mm to 0.7mm, for example, 0.1mm, 0.15mm, 0.2mm, 0.3mm, or 0.5mm; the inner arc diameter of the first curved section 134 is 0.05mm to 0.5mm, for example, 0.1mm, 0.15mm, 0.2mm, 0.3mm, or 0.4mm.

[0047] Optionally, each support unit 131 includes a second curved section 132 and two connecting sections 133. Both ends of the second curved section 132 are connected to the two connecting sections 133, and the ends of the two connecting sections 133 furthest from the second curved section 132 are connected to two first curved sections 134. A through hole 101 penetrates a portion of the connecting section 133. In this embodiment, the second curved section 132 and the first curved sections 134 are staggered.

[0048] In other embodiments, the support unit 131 includes a plurality of continuously connected second curved segments 132 and at least two connecting segments 133, with the two ends of the second curved segments 132 respectively connected to the two connecting segments 133.

[0049] Optionally, the two connecting segments 133 are symmetrically arranged, and the included angle between the two connecting segments 133 is greater than 0° and less than 150°.

[0050] Optionally, the second curved segment 132 is semi-circular, and the shape and structure of the second curved segment 132 are the same as those of the first curved segment 134. The outer arc diameter of the second curved segment 132 is 0.07mm to 0.7mm, for example, 0.1mm, 0.15mm, 0.2mm, 0.3mm, or 0.5mm; the inner arc diameter of the second curved segment 132 is 0.05mm to 0.5mm, for example, 0.1mm, 0.15mm, 0.2mm, 0.3mm, or 0.4mm.

[0051] Optionally, by using the software ABAQUS to perform an expansion simulation analysis on a single support 13 (finite element simulation analysis is often used as an important research method in the design and development of medical devices), it can be seen that the stress is mainly concentrated in the first bending section 134 and the second bending section 132. The stress is smaller closer to the middle of the connecting section 133. Therefore, placing the through hole 101 near the middle of the connecting section 133 can prevent the support 13 from breaking.

[0052] Optionally, Figure 2b This is a side view structural diagram of the connection segment of this application, as shown below. Figure 2a and Figure 2bAs shown, the connecting section 133 includes a first section 133a, a second section 133b, and a third section 133c. The second section 133b connects the first section 133a and the third section 133c. The first section 133a connects to the first curved section 134, and the third section 133c connects to the second curved section 132. A through hole 101 is provided in the second section 133b. In this embodiment, the first section 133a and the third section 133c do not have through holes 101, which can effectively prevent the support body 13 from breaking.

[0053] Optionally, such as Figure 2a and Figure 2b As shown, the connecting segment 133 includes a first surface 1331 and a second surface 1332 disposed opposite to each other. The first surface 1331 is close to the outer surface of the inner membrane 11, that is, the first surface 1331 is the inner surface of the support 13, and the second surface 1332 is the outer surface of the support 13. The through hole 101 is located between the first surface 1331 and the second surface 1332. The height h of the through hole 101 along the direction perpendicular to the first surface 1331 and the second surface 1332 is less than or equal to 1 / 2 of the vertical distance L1 between the first surface 1331 and the second surface 1332, which can effectively prevent the support 13 from breaking.

[0054] Optionally, the length L2 of the through hole 101 along the length direction of the connecting segment 133 is 1 / 2 to 2 / 3 of the length L3 of the connecting segment 133, which can effectively prevent the support 13 from breaking.

[0055] Optionally, the vascular stent graft 10 includes a plurality of support structures 12 and a plurality of connectors 15. The plurality of support structures 12 are arranged at intervals along the axial direction of the inner membrane 11, and adjacent support structures 12 are connected by at least one connector 15. By increasing or decreasing the number of support structures 12 in the axial direction of the inner membrane 11, vascular stent grafts 10 of different lengths can be obtained.

[0056] Optionally, the connector 15 is Ω-shaped and is connected between the first curved section 134 and the second curved section 132 of two adjacent support structures 12.

[0057] Second Embodiment

[0058] Figure 3 This is a schematic diagram of the structure of the vascular covered stent according to the second embodiment of this application. Figure 4 This is a schematic diagram of the structure of the support body according to the second embodiment of this application, as shown below. Figure 3 and Figure 4 As shown, the vascular stent graft 10 of this embodiment has a structure that is largely the same as that of the vascular stent graft 10 of the first embodiment, except that the number of through holes 101 is different.

[0059] Optionally, such as Figure 3 and Figure 4 As shown, the support body 13 has multiple through holes 101, which are arranged at intervals along the axial direction of the inner membrane 11. The support structure 12 includes multiple connecting membranes 14, which pass through the multiple through holes 101 and surround the inner membrane 11. The number of through holes 101 can be freely designed according to actual needs; for example, the support body 13 may have two or more through holes 101. In this embodiment, each connecting segment 133 of each support unit 131 has multiple through holes 101, which are arranged at intervals along the length of the connecting segment 133.

[0060] Third Embodiment

[0061] Figure 5 This is a schematic diagram of the structure of the connector according to the third embodiment of this application, as shown below. Figure 5 As shown, the vascular stent graft 10 of this embodiment has a structure that is largely the same as that of the vascular stent graft 10 of the first embodiment, except that the structure of the connector 15 is different.

[0062] Optionally, such as Figure 5 As shown, the connector 15 includes a bent portion 151, a first connecting portion 152, and a second connecting portion 153. The bent portion 151 is S-shaped, with one end connected to the first connecting portion 152 and the other end connected to the second connecting portion 153. The first connecting portion 152 is connected to the first bent segment 134 of the adjacent support 13, and the second connecting portion 153 is connected to the second bent segment 132 of the adjacent support 13. In this embodiment, the first connecting portion 152 is parallel to the second connecting portion 153, and the bent portion 151 connects the first connecting portion 152 and the second connecting portion 153. Preferably, the first connecting portion 152 and the second connecting portion 153 are parallel to the axis of the vascular graft 10, or the first connecting portion 152 and the second connecting portion 153 are inclined along the axis of the vascular graft 10.

[0063] Fourth embodiment

[0064] Figure 6 This is a schematic diagram of the structure of the connector according to the fourth embodiment of this application, as shown below. Figure 6 As shown, the vascular covered stent 10 of this embodiment has a similar structure to the vascular covered stent 10 of the third embodiment, except that the orientation of the curved portion 151 is different.

[0065] Optionally, the bending portion 151 in this embodiment is positioned perpendicular to the bending portion 151 in the third embodiment.

[0066] Fifth embodiment

[0067] Figure 7 This is a schematic diagram of the structure of the connector according to the fifth embodiment of this application, as shown below. Figure 7 As shown, the vascular covered stent 10 of this embodiment has a structure that is generally the same as the vascular covered stent 10 of the above embodiment, except that the structure of the connector 15 is different.

[0068] Optionally, such as Figure 7 As shown, the connector 15 is in the shape of a straight strip, and the length direction of the connector 15 is parallel to the axis of the vascular covered stent 10.

[0069] In other embodiments, the connector 15 is wavy, sawtooth, square, or plate-shaped.

[0070] Sixth Embodiment

[0071] Figure 8 This is a schematic diagram of the structure of the connector according to the sixth embodiment of this application, as shown below. Figure 7 As shown, the vascular covered stent 10 of this embodiment has a structure that is roughly the same as the vascular covered stent 10 described above, except that no connecting body 15 is provided between two adjacent supports 13.

[0072] Optionally, the vascular endothelial stent 10 includes a plurality of support structures 12, which are arranged at intervals along the axial direction of the inner membrane 11.

[0073] Optionally, the support body 13 of the support structure 12 is formed by a plurality of support units 131 and a first curved section 134 connecting two adjacent support units 131; the number of support bodies 13 of at least one support structure 12 is different from the number of support bodies 13 of other support structures 12, so as to meet the requirements of different support forces and different expansion diameters.

[0074] Optionally, the spacing between at least two adjacent support structures 12 is different from the spacing between other two adjacent support structures 12, so as to achieve different axial flexibility and support of the vascular covered stent 10.

[0075] Seventh Embodiment

[0076] This application also relates to a method for fabricating the above-mentioned vascular covered stent, the method comprising:

[0077] An inner membrane 11 and a connecting membrane 14 are provided, and the inner membrane 11 and the connecting membrane 14 are surface treated.

[0078] Provide a core rod, and fit the inner membrane 11 onto the core rod;

[0079] A support body 13 is provided, and a connecting membrane 14 is inserted through the through hole 101 of the support body 13 and surrounds the support body 13; the support body 13 with the connecting membrane 14 is fitted onto the outer surface of the inner membrane 11.

[0080] A pressurizing device is provided, which is used to wrap the outer surface of the support 13;

[0081] A heating box is provided, and the above-mentioned combined structure is placed in the heating box for heating treatment; after heating for a set time, the combined structure is taken out, and the pressure device and mandrel are removed to form a vascular covered stent 10.

[0082] Optionally, the surface treatment methods for the inner membrane 11 and / or the connecting membrane 14 include any one or more of the following:

[0083] Use surface modifiers containing boron groups and amino groups;

[0084] Sodium naphthalene etching method was used;

[0085] ArF laser treatment method;

[0086] Chemical grafting is used. In this embodiment, surface treatment of the inner membrane 11 and / or the connecting membrane 14 ensures better adhesion performance. It should be noted that the above methods are only specific examples, and in practical applications, this includes, but is not limited to, using only the above methods for processing.

[0087] Optionally, the combined structure is placed in a heating chamber and the temperature is controlled within the range of 300℃ to 375℃, for example, 320℃, 330℃, 340℃, or 350℃; the sintering time is controlled within the range of 5 to 20 minutes, for example, 7, 10, 12, 15, or 18 minutes.

[0088] Eighth embodiment

[0089] Figure 9 This is a schematic diagram of the structure of the covered stent delivery system according to the eighth embodiment of this application, as shown below. Figure 9 As shown, the covered stent delivery system 30 is used to deliver the aforementioned vascular covered stent 10 into a blood vessel. The covered stent delivery system 30 includes a connector 31, a guidewire 32, a fluid guide tube 33, a balloon 34, and a contrast ring (not shown). The connector 31 has a guidewire lumen and a fluid passage lumen. The guidewire 32 and the fluid guide tube 33 are both connected to the connector 31. The guidewire 32 communicates with the guidewire lumen, and the fluid guide tube 33 communicates with the fluid guide lumen. The guidewire 32 passes through the fluid guide tube 33, and the end of the guidewire 32 extends from the end of the fluid guide tube 33. One end of the balloon 34 is connected to the guidewire 32, and the other end of the balloon 34 is connected to the fluid guide tube 33. The fluid guide tube 33 communicates with the balloon 34. The contrast ring is connected to the guidewire 32, and the vascular covered stent 10 is mounted on the balloon 34. In this embodiment, the guidewire tube 32 is used to pass through the guidewire, which can pass through the guidewire cavity of the connector 31 and the guidewire tube 32; the liquid tube 33 is used to pass through the liquid, which can enter the balloon 34 from the liquid cavity of the connector 31 and the liquid tube 33, forcing the balloon 34 to inflate.

[0090] Optionally, the balloon 34 is located at the end of the guidewire 32 and the fluid guide tube 33 away from the connector 31. One end of the balloon 34 is connected to the fluid guide tube 33 by laser welding, thermal welding or adhesive bonding, and the other end of the balloon 34 is connected to the guidewire 32 by laser welding, thermal welding or adhesive bonding.

[0091] Optionally, the balloon 34 is made of materials such as PET, PEBAX, PU, ​​PA, etc., and is blow-molded by a balloon 34 molding machine.

[0092] Optionally, the diameter of the balloon 34 is 2 to 15 mm, for example, 4, 6, 8, or 12 mm; and the length of the balloon 34 is 10 to 200 mm, for example, 20, 40, 60, 120, or 150 mm.

[0093] Optionally, the guide wire tube 32 and / or the liquid guide tube 33 are made of materials such as PET, PEBAX, PU, ​​PA, etc., through extrusion molding.

[0094] Optionally, the imaging ring is a platinum-iridium alloy ring for in vivo imaging.

[0095] The steps of the covered stent delivery system 30 of this application in delivering the covered stent 10 into a blood vessel include:

[0096] Step 1: Establish the access route using conventional interventional procedures, including vascular sheath, guide sheath, guidewire, etc., and determine the lesion location where the vascular stent graft 10 will be placed.

[0097] Step 2: Use the balloon 34 folding machine to fold the balloon 34 to a small diameter and give it shape memory.

[0098] Step 3: Press the vascular covered stent 10 onto the balloon 34 using a stent clamping machine.

[0099] Step four: Using the covered stent delivery system 30, push the stent forward along the pre-placed guidewire to the target position, and then fill the balloon 34 with liquid through the fluid inlet and the fluid inlet tube 33, causing the balloon 34 to expand, thereby causing the vascular covered stent 10 to expand until it adheres to the blood vessel wall.

[0100] Step 5: The fluid inside the balloon 34 is aspirated through the fluid inlet and the fluid inlet tube 33, causing the inflated balloon 34 to retract. Finally, the covered stent delivery system 30 is withdrawn. At this point, the vascular covered stent 10 has been placed in the target position and the treatment task has been completed.

[0101] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in this application should still be covered by the claims of this application.

Claims

1. A vascular covered stent, characterized in that, The device includes a tubular inner membrane and at least one support structure. The support structure includes a support body and at least one connecting membrane. The support body surrounds the outer surface of the inner membrane and has a through hole. The connecting membrane passes through the through hole and surrounds the inner membrane, and is connected to the inner membrane. The support body is wavy and curved. The support body includes multiple support units and multiple first curved sections. The multiple support units are spaced apart from each other around the axis of the inner membrane. Adjacent support units are connected by a first curved section. Each support unit has the through hole. The connecting membrane passes through the through holes of the multiple support units and surrounds the support unit. The support body includes an inner surface and an outer surface that are disposed opposite each other. The through hole is located between the inner surface and the outer surface of the support body. The height of the through hole in the direction perpendicular to the inner surface and the outer surface is less than or equal to 1 / 2 of the vertical distance between the inner surface and the outer surface.

2. The vascular covered stent as described in claim 1, characterized in that, Each of the support units includes a second curved section and two connecting sections. The two ends of the second curved section are respectively connected to the two connecting sections, and the ends of the two connecting sections away from the second curved section are respectively connected to the two first curved sections. The through hole penetrates a local section of the connecting section.

3. The vascular covered stent as described in claim 2, characterized in that, The connecting segment includes a first segment, a second segment, and a third segment. The second segment connects the first segment and the third segment. The first segment connects to the first curved segment. The third segment connects to the second curved segment. The through hole is provided in the second segment.

4. The vascular covered stent as described in claim 3, characterized in that, The length of the through hole along the length of the connecting segment is 1 / 2 to 2 / 3 of the length of the connecting segment.

5. The vascular covered stent as described in claim 1, characterized in that, The support unit is provided with a plurality of through holes, which are arranged at intervals along the axial direction of the inner membrane. The support structure includes a plurality of connecting membranes, which pass through the plurality of through holes and surround the inner membrane.

6. The vascular covered stent as described in claim 1, characterized in that, The vascular covered stent includes a plurality of support structures, which are arranged at intervals along the axial direction of the inner membrane.

7. The vascular covered stent as described in claim 6, characterized in that, The support structure is formed by a plurality of support units and a first curved section connecting two adjacent support units; the number of supports in at least one support structure is different from the number of supports in the other support structures.

8. The vascular covered stent as described in claim 6, characterized in that, The vascular covered stent also includes multiple connectors, and two adjacent support structures are connected by at least one connector; the connectors are in the form of straight strips, waves, serrations, square waves, or Ω shapes.

9. A method for manufacturing a vascular stent graft as described in any one of claims 1 to 8, characterized in that, The manufacturing method includes: The inner membrane and the connecting membrane are provided, and the inner membrane and the connecting membrane are surface treated. A core rod is provided, and the inner layer membrane is fitted onto the core rod; The support body is provided, the connecting membrane is inserted through the through hole of the support unit and surrounds the support unit once; the support body with the connecting membrane is fitted onto the outer surface of the inner membrane; A pressurizing device is provided, which is used to wrap the outer surface of the support. The stent is placed in a heating chamber for heating treatment; after heating for a set time, it is removed and the pressurizing device and the mandrel are removed to form the vascular covered stent.

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