WO2023246929A1 - Vascular covered stent and manufacturing method therefor, and covered stent conveying system - Google Patents

Abstract

The present invention provides a vascular covered stent, comprising an inner membrane in a tubular shape and at least one support structure which comprises a support body and at least one connecting membrane, the support body surrounding the outer surface of the inner membrane, through holes being formed in the support body, the connecting membrane passing through the through holes and being arranged around the inner membrane, and the connecting membrane being connected to the inner membrane. The vascular covered stent provided by the present application has small diameter and can be conveniently placed in a blood vessel. Further provided in the present application are a manufacturing method for the vascular covered stent and a covered stent conveying system.

Description

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

The invention relates to the technical field of medical devices, and in particular to a vascular covered stent, a manufacturing method thereof, and a covered stent delivery system.

Background technique

With the improvement of people's living standards, great changes have taken place in diet structure, lifestyle and other styles, which has led to an increasing incidence of vascular diseases. Common vascular diseases include aneurysm, vascular perforation, vascular rupture, vascular dissection, atherosclerosis, vascular embolism, etc. In order to avoid the high intraoperative and postoperative risks caused by traditional surgeries, vascular stents have become the most widely used medical device commonly used in minimally invasive interventional surgeries. Interventional surgery has the advantages of minimally invasive therapy such as small incision, mild pain, and quick recovery. With the support of modern medical imaging technology, the vascular stent is guided by a guide wire and uses the principle of expanding itself to a certain diameter or balloon expansion molding to insert the stent into the blood vessel at the stenotic segment of the disease to support the narrowed and occluded segment of the blood vessel and reduce vascular return. The purpose of shrinkage, maintaining smooth blood flow in the blood cavity and reshaping.

A covered stent is a stent covered with a special membrane material on the surface of a metal stent. It not only has the functions of traditional vascular stents, but also has the characteristics of membrane materials, so it can be used in many fields that ordinary vascular stents cannot solve. For example, when there is an emergency such as blood vessel perforation or blood vessel rupture, bleeding can be effectively controlled by placing a covered stent; when the blood vessel elasticity at the diseased site is seriously insufficient, or severe calcification, diffuse thrombosis or even complete occlusion occurs at the diseased site, use Ordinary vascular stents may cause serious risks such as blood vessel tearing, blood vessel dissection, thrombus detachment, and thrombus displacement before remedial surgery is performed. However, if a covered stent is used for expansion, the vascular stent is used to shape the lumen, and the membranous material can block the blood flow, then the covered stent can complete the treatment of this type of disease very safely. And from the clinical effect point of view, the primary patency rate and target lesion reconstruction rate of covered stents are significantly higher than that of bare stents.

technical problem

The existing stent graft includes an inner membrane, an outer membrane, and a supporting frame connected between the inner membrane and the outer membrane. Since the outer membrane covers the outer surface of the supporting frame, the overall diameter of the covered stent is too large, which is not conducive to placing it in the blood vessel. Moreover, the manufacturing process of the existing covered stent is difficult and costly.

Technical solutions

In order to solve the above-mentioned defects in the prior art, the present invention aims to provide a vascular covered stent with a small diameter and is easy to be placed in a blood vessel.

The invention provides a vascular covered stent, which 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 a through hole is provided in the support body. hole, the connecting film passes through the through hole and is arranged around the inner layer film, and the connecting film is connected to the inner layer film.

Optionally, the support body is in a wavy curved shape; the support body includes a plurality of support units and a plurality of first curved sections, and the plurality of support units are spaced apart from each other around the axis of the inner film. Two adjacent support units are connected through one of the first curved sections, each support unit is provided with a through hole, and the connecting film passes through the through holes of multiple support units.

Optionally, each of the support units includes a second curved section and two connecting sections. Both ends of the second curved section are respectively connected to the two connecting sections, and the two connecting sections are away from the second connecting section. One end of the curved section is connected to the two first curved sections respectively, and the through hole penetrates a local section of the connecting section.

Optionally, the connection section includes a first section, a second section and a third section, the second section is connected between the first section and the third section, and the The first section is connected to the first curved section, the third section is connected to the second curved section, and the through hole is provided in the second section.

Optionally, the connection section includes a first surface and a second surface arranged oppositely, the first surface is close to the outer surface of the inner film, and the through hole is located between the first surface and the second surface. Between the surfaces, the height of the through hole along the direction perpendicular to the first surface and the second surface is less than or equal to 1/2 of the vertical distance between the first surface and the second surface.

Optionally, the length of the through hole along the length direction of the connecting section is 1/2 to 2/3 of the length of the connecting section.

Optionally, a plurality of the through holes are provided in the support body, and the plurality of through holes are arranged at intervals along the axial direction of the inner film. The support structure includes a plurality of the connecting films, and a plurality of the through holes are arranged at intervals along the axial direction of the inner film. Each of the connecting films respectively passes through a plurality of the through holes and is arranged around the inner layer film.

Optionally, the stent graft includes a plurality of support structures, and the plurality of support structures are spaced apart from each other along the axial direction of the inner membrane.

Optionally, the support body of the support structure is formed by a plurality of support units and a first curved section connected between two adjacent support units; the number of the support bodies of at least one of the support structures is different from that of other support units. The number of the support bodies of the support structure is different; and/or,

The spacing between at least two adjacent supporting structures is different from the spacing between other two adjacent supporting structures.

Optionally, the stent graft also includes a plurality of connectors, and two adjacent support structures are connected by at least one connector; the connectors are in a straight strip shape, a wavy shape, or a zigzag shape. , square waveform, version waveform or Ω type.

The present application also provides a method for producing the above-mentioned vascular covered stent, which method includes:

Provide the inner layer film and the connecting film, and perform surface treatment on the inner layer film and the connecting film;

Provide a core rod, and put the inner film on the core rod;

Provide the support body, insert the connection film from the through hole of the support body and surround the support body; put the support body with the connection film on the inner film the outer surface;

Provide a pressurizing device, using the pressurizing device to wrap the outer surface of the support body;

A heating box is provided, and the above combined structure is put into 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 stent graft.

This application also provides a stent graft delivery system, which is used to deliver the above-mentioned vascular stent graft into the blood vessel. The stent graft delivery system includes a connector, a guide wire tube, and a catheter tube. , balloon and developing ring, the connecting piece is provided with a guide wire cavity and a liquid-passing cavity, the guide wire tube and the catheter tube are connected to the connecting piece, and the guide wire tube is connected to the guide wire tube. The wire cavity is connected, the catheter tube is connected with the liquid catheter cavity, the wire guide tube is penetrated in the catheter tube, and the end of the wire guide tube extends from the end of the catheter tube , one end of the balloon is connected to the guide wire tube, the other end of the balloon is connected to the catheter tube, the catheter tube is connected to the balloon, and the developing ring is connected to the On the guide wire tube, the vascular covered stent is installed on the balloon.

beneficial effects

The support body of the vascular covered stent of the present application is provided with a through hole, and the connecting film can be penetrated through the through hole and surrounds the supporting body, which avoids placing the connecting film on the outer surface of the supporting body and causing the overall appearance of the vascular covered stent. Therefore, the diameter of the vascular stent graft of the present application is smaller, which is easier to place in the blood vessel, and the entire stent is more tightly integrated, making the vascular stent graft as a whole softer.

Description of the drawings

Figure 1 is a schematic structural diagram of a vascular stent graft according to the first embodiment of the present application.

Figure 2 is a schematic structural diagram of a support body according to the first embodiment of the present application.

Figure 3 is a schematic side view of the connecting section of the present application.

Figure 4 is a schematic structural diagram of a vascular stent graft according to the second embodiment of the present application.

Figure 5 is a schematic structural diagram of a support body according to the second embodiment of the present application.

Figure 6 is a schematic structural diagram of a connector according to the third embodiment of the present application.

Figure 7 is a schematic structural diagram of a connector according to the fourth embodiment of the present application.

Figure 8 is a schematic structural diagram of a connector according to the fifth embodiment of the present application.

Figure 9 is a schematic structural diagram of a connector according to the sixth embodiment of the present application.

Figure 10 is a schematic structural diagram of a stent graft delivery system according to the eighth embodiment of the present application.

Embodiments of the invention

The following describes the implementation of the present application through specific embodiments. Those familiar with this technology can easily understand other advantages and effects of the present application from the content disclosed in this specification.

In the following description, reference is made to the accompanying drawings, which illustrate several embodiments of the application. It is to be understood that other embodiments may be utilized and mechanical, structural, electrical, as well as operational changes 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 the purpose of describing particular embodiments only and is not intended to limit the application.

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

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" and "including" indicate the presence of features, steps, operations, elements, components, items, categories, and/or groups, but do not exclude one or more other features, steps, operations, elements, The presence, occurrence, or addition of components, items, categories, and/or groups. The terms "or" and "and/or" as used herein are to be construed as inclusive or to mean any one or any combination. Therefore, "A, B or C" or "A, B and/or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C" . Exceptions to this definition occur only when the combination of elements, functions, steps, or operations is inherently mutually exclusive in some manner.

First embodiment

Figure 1 is a schematic structural diagram of a vascular stent graft according to the first embodiment of the present application. Figure 2 is a schematic structural diagram of a support body according to the first embodiment of the present application. As shown in Figures 1 and 2, the vascular stent graft 10 includes a The 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. The support body 13 is provided with a through hole 101. The connection film 14 passes through the through hole 101 and is arranged around the inner film 11 , and the connection film 14 is connected to the inner film 11 . In this embodiment, the connecting film 14 and the inner film 11 can be tightly bonded together by heating or gluing, so that the support 13 , the connecting film 14 and the inner film 11 are made into three types. A vascular covered stent 10 that can be used for vascular shaping is formed.

The support body 13 of the stent graft 10 of the present application is provided with a through hole 101, and the connecting membrane 14 can penetrate through the through hole 101 and surround the supporting body 13, thus avoiding the need to place the connecting membrane 14 on the supporting body 13. The outer surface causes an increase in the overall outer diameter of the vascular stent graft 10. Therefore, the outer diameter of the vascular stent graft 10 of the present application is smaller, which is easier to place in the blood vessel, and the entire stent is more tightly integrated, making the vascular stent graft 10 Softer overall.

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

Optionally, the support body 13 has expansion and contraction functions; the support body 13 is made of superelastic materials such as nickel-titanium through laser cutting or chemical etching or 3D printing, and can also be made of cobalt-chromium alloy, stainless steel, magnesium alloy, aluminum Alloy, PLA and other materials are made by laser cutting or chemical etching or 3D printing. In this embodiment, the stent graft 10 requires a smaller outer diameter to enter the blood vessel, and a larger outer diameter when reaching the target lesion location for work. The function of diameter change is reflected by the change of the support body 13 .

Optionally, the support body 13 is a tubular structure connected end to end, and the support body 13 is in a wavy curved shape; the support body 13 includes a plurality of support units 131 and a plurality of first curved sections 134, and the plurality of support units 131 surround the inner The axes of the film 11 are spaced apart from each other. Two adjacent support units 131 are connected through a first curved section 134. Each support unit 131 is provided with a through hole 101. The connecting film 14 passes through the through holes 101 of multiple support units 131. ; The expansion and contraction of the diameter of the support body 13 is ultimately achieved by the increase and decrease of the angle of the support unit 131. In this embodiment, the connection film 14 passes through the through holes 101 of each support unit 131 , that is, the connection film 14 connects multiple support units 131 in series, and the connection films 14 are connected end to end to form a ring.

Optionally, two adjacent support units 131 are connected to a first curved section 134 in a smooth transition. For example, the outer surface of the support unit 131 and the outer surface of the first curved section 134 are located on the same horizontal plane, and the inner surface of the support unit 131 is connected to the first curved section 134 . The inner surface of a curved section 134 is located on the same horizontal plane, or the support unit 131 and the first curved section 134 are transitionally connected through an arc structure, but it is not limited to this.

Optionally, the first curved section 134 is semicircular, and the outer arc diameter of the first curved section 134 is 0.07mm~0.7mm, such as 0.1mm, 0.15mm, 0.2mm, 0.3mm, 0.5mm; The inner arc diameter of the segment 134 is 0.05mm～0.5mm, such as 0.1mm, 0.15mm, 0.2mm, 0.3mm, 0.4mm.

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 respectively connected to the two connecting sections 133, and the two connecting sections 133 are away from the second curved section 132. One end is connected to the two first curved sections 134 respectively, and the through hole 101 penetrates a partial section of the connecting section 133 . In this embodiment, the second curved section 132 and the first curved section 134 are arranged staggered from each other.

In other embodiments, the support unit 131 includes a plurality of continuously connected second bending sections 132 and at least two connecting sections 133 , and both ends of the second bending section 132 are respectively connected to the two connecting sections 133 .

Optionally, the two connecting sections 133 are arranged symmetrically, and the angle between the two connecting sections 133 is greater than 0° and less than 150°.

Optionally, the second curved section 132 is semicircular. The second curved section 132 has the same shape and structure as the first curved section 134 . The outer arc diameter of the second curved section 132 is 0.07mm˜0.7mm, for example, 0.1 mm, 0.15mm, 0.2mm, 0.3mm, 0.5mm; the inner arc diameter of the second bending section 132 is 0.05mm～0.5mm, such as 0.1mm, 0.15mm, 0.2mm, 0.3mm, 0.4mm.

Optionally, use the software ABAQUS to perform expansion simulation analysis on a single support body 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 closer to the middle of the connecting section 133, the smaller the stress. Therefore, placing the through hole 101 near the middle of the connecting section 133 can prevent the support body 13 from breaking.

Optionally, Figure 3 is a schematic side view of the connecting section of the present application. As shown in Figures 2 and 3, the connecting section 133 includes a first section 133a, a second section 133b and a third section 133c. The second section 133b is connected between the first section 133a and the third section 133c, the first section 133a is connected to the first curved section 134, the third section 133c is connected to the second curved section 132, and the through hole 101 is provided in the second section 133b. In this embodiment, the first section 133a and the third section 133c are not provided with through holes 101, which can effectively prevent the support body 13 from breaking.

Optionally, as shown in FIGS. 2 and 3 , the connecting section 133 includes a first surface 1331 and a second surface 1332 arranged oppositely. The first surface 1331 is close to the outer surface of the inner film 11 , that is, the first surface 1331 is a support. The inner surface of the body 13, the second surface 1332 is the outer surface of the support body 13, the through hole 101 is located between the first surface 1331 and the second surface 1332, the through hole 101 is in a direction perpendicular to the first surface 1331 and the second surface 1332 The height h 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 body 13 from breaking.

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

Optionally, the stent graft 10 includes multiple support structures 12 and multiple connectors 15 . The multiple support structures 12 are spaced apart from each other along the axial direction of the inner membrane 11 . Between two adjacent support structures 12 are connected through at least one connector 15. By increasing or decreasing the number of supporting structures 12 in the axial direction of the inner membrane 11, vascular stent grafts 10 of different lengths can be obtained.

Optionally, the connecting body 15 is in an Ω shape, and the connecting body 15 is connected between the first bending section 134 and the second bending section 132 of two adjacent support structures 12 .

Second embodiment

Figure 4 is a schematic structural diagram of a vascular covered stent according to the second embodiment of the present application. Figure 5 is a schematic structural diagram of a support body according to the second embodiment of the present application. As shown in Figures 4 and 5, the vascular covered stent of this embodiment The structure of the stent 10 is substantially the same as that of the vascular covered stent 10 of the first embodiment, except that the number of through holes 101 is different.

Optionally, as shown in FIGS. 4 and 5 , the support body 13 is provided with a plurality of through holes 101 , the plurality of through holes 101 are arranged at intervals along the axial direction of the inner film 11 , and the support structure 12 includes a plurality of connections. The film 14 and the plurality of connection films 14 respectively pass through the plurality of through holes 101 and are arranged around the inner film 11 . The number of through holes 101 can be freely designed according to actual needs. For example, the support body 13 is provided with two or more through holes 101 . In this embodiment, each connecting section 133 of each support unit 131 is provided with a plurality of through holes 101 , and the plurality of through holes 101 are arranged at intervals along the length direction of the connecting section 133 .

Third embodiment

Figure 6 is a schematic structural diagram of a connector according to the third embodiment of the present application. As shown in Figure 6, the structure of the vascular stent graft 10 of this embodiment is roughly the same as that of the vascular stent graft 10 of the first embodiment. The difference lies in the connection. Body 15 has a different structure.

Optionally, as shown in FIG. 6 , the connecting body 15 includes a bending part 151 , a first connecting part 152 and a second connecting part 153 . The bending part 151 is bent in an S shape, and one end of the bending part 151 is connected to the first connecting part 152 , the other end of the bending part 151 is connected to the second connecting part 153, the first connecting part 152 is connected to the first bending section 134 of the adjacent support body 13, and the second connecting part 153 is connected to the second bending section of the adjacent support body 13. Segment 132 is connected. In this embodiment, the first connecting part 152 is parallel to the second connecting part 153, and the bending part 151 is connected between the first connecting part 152 and the second connecting part 153; preferably, the first connecting part 152 and the second connecting part 153 are The portion 153 is parallel to the axis of the stent-graft 10 , or the first connecting portion 152 and the second connecting portion 153 are inclined along the axis of the stent-graft 10 .

Fourth embodiment

Figure 7 is a schematic structural diagram of a connector according to the fourth embodiment of the present application. As shown in Figure 7, the structure of the vascular stent graft 10 of this embodiment is roughly the same as that of the vascular stent graft 10 of the third embodiment. The difference lies in the bending. The installation orientation of the part 151 is different.

Optionally, the arrangement direction of the bending portion 151 of this embodiment is perpendicular to the arrangement direction of the bending portion 151 of the third embodiment.

Fifth embodiment

Figure 8 is a schematic structural diagram of a connector according to the fifth embodiment of the present application. As shown in Figure 8 , the vascular stent graft 10 of this embodiment has roughly the same structure as the vascular stent graft 10 of the above-mentioned embodiment. The difference lies in the connector. 15 has a different structure.

Optionally, as shown in FIG. 8 , 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 stent graft 10 .

In other embodiments, the connecting body 15 is in the shape of a wave, a zigzag, a square wave, or a wave shape.

Sixth embodiment

Figure 9 is a schematic structural diagram of a connector according to the sixth embodiment of the present application. As shown in Figure 9, the vascular stent graft 10 of this embodiment has roughly the same structure as the vascular stent graft 10 described above. The difference lies in the two adjacent supports. There is no connecting body 15 provided between the bodies 13 .

Optionally, the stent graft 10 includes a plurality of support structures 12 arranged at intervals along the axial direction of the inner membrane 11 .

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 connected between two adjacent support units 131; the number of the support bodies 13 of at least one support structure 12 is different from that of other supports. The number of supporting bodies 13 of the structure 12 is different to meet the requirements of different supporting forces and different expansion diameters.

Optionally, the distance between at least two adjacent support structures 12 is different from the distance between two other adjacent support structures 12, so as to realize that the stent graft 10 has different flexibility and support in the axial direction.

Seventh embodiment

The present application also relates to a method for manufacturing the above-mentioned vascular covered stent. The manufacturing method includes:

Provide the inner layer film 11 and the connecting film 14, and perform surface treatment on the inner layer film 11 and the connecting film 14;

Provide a mandrel, and put the inner film 11 on the mandrel;

Provide a support body 13, insert the connection film 14 from the through hole 101 of the support body 13 and surround the support body 13; put the support body 13 with the connection film 14 on the outer surface of the inner film 11;

Provide a pressurizing device, and use the pressurizing device to wrap the outer surface of the support body 13;

A heating box is provided, and the above combined structure is put into 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 stent graft 10 .

Optionally, the surface treatment method for the inner film 11 and/or the connecting film 14 includes any one or more of the following:

Use surface modifiers containing boron groups and amino groups;

Use sodium naphthalene etching method;

Using ArF laser processing method;

Use chemical grafting method. In this embodiment, by performing surface treatment on the inner film 11 and/or the connecting film 14, it is possible to ensure that the films have better adhesive properties. It should be noted that the above methods are only specific examples, and practical applications include but are not limited to using only the above methods for processing.

Optionally, put the combined structure into a heating box, control the temperature range from 300°C to 375°C, such as 320°C, 330°C, 340°C, 350°C; control the sintering time to 5 to 20 minutes, such as 7, 10, 12, 15, 18 minutes.

Eighth embodiment

Figure 10 is a schematic structural diagram of a stent graft delivery system according to the eighth embodiment of the present application. As shown in Figure 10, the stent graft delivery system 30 is used to deliver the above-mentioned vascular stent graft 10 into the blood vessel. The stent graft delivery system 30 includes a connecting piece 31, a guidewire tube 32, a catheter tube 33, a balloon 34 and a developing ring (not shown). The connector 31 is provided with a guidewire cavity and a liquid-passing cavity. The guidewire tube 32 and the catheter tube are 33 are connected to the connector 31, the guide wire tube 32 is connected to the guide wire cavity, the catheter tube 33 is connected to the liquid catheter cavity, the guide wire tube 32 is penetrated in the catheter tube 33, and the end of the guide wire tube 32 is connected to the guide wire cavity. The end of the liquid tube 33 extends out, one end of the balloon 34 is connected to the guide wire tube 32, the other end of the balloon 34 is connected to the catheter tube 33, the catheter tube 33 is connected with the balloon 34, and the developing ring is connected to the guide wire On the tube 32, the vascular stent graft 10 is installed on the balloon 34. In this embodiment, the guidewire tube 32 is used to pass a guidewire, and the guidewire can pass through the guidewire cavity of the connector 31 and the guidewire tube 32; the catheter tube 33 is used to pass liquid, and the liquid can pass through the connector 31. The catheter lumen of 31 and the catheter 33 enter the balloon 34, forcing the balloon 34 to expand.

Optionally, the balloon 34 is located at the end of the guide wire tube 32 and the catheter tube 33 away from the connector 31. One end of the balloon 34 is connected to the catheter tube 33 through laser welding, heat welding or glue. The other end is connected to the wire guide tube 32 through laser welding, heat welding or adhesive bonding.

Optionally, the balloon 34 is made of PET, PEBAX, PU, PA and other materials and is blown by a balloon 34 molding machine.

Optionally, the diameter of the balloon 34 is 2 to 15 mm, such as 4, 6, 8, and 12 mm; the length of the balloon 34 is 10 to 200 mm, such as 20, 40, 60, 120, and 150 mm.

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

Optionally, the development ring is a platinum-iridium alloy ring, which is used for development in the body.

The steps of the stent graft delivery system 30 of the present application to deliver the stent graft 10 into the blood vessel include:

Step 1: Use conventional interventional surgical operations to establish operating channels, such as vascular sheaths, guide sheaths, guide wires, etc., and determine the location of the lesion where the vascular covered stent 10 is to be placed.

Step 2: Use a balloon 34 folding machine to fold the balloon 34 to a small diameter and make it have shape memory.

Step 3: The vascular covered stent 10 is pressed onto the balloon 34 using a stent pressing machine.

Step 4: Use the stent graft delivery system 30 to push the stent graft forward along the placed guide wire to the target position, and then fill the interior of the balloon 34 with liquid through the catheter chamber and catheter 33 to expand the balloon 34. Thereby, the stent graft 10 is driven to expand until it fits the blood vessel wall.

Step 5: Suck out the liquid inside the balloon 34 through the catheter cavity and catheter 33, causing the inflated balloon 34 to retract, and finally withdraw the stent graft delivery system 30. At this time, the vascular stent graft 10 has been placed at the target position. Treatment tasks completed.

The above embodiments only illustrate the principles and effects of the present application, but are not used to limit the present application. Anyone familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present application. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed in this application shall still be covered by the claims of this application.

Industrial applicability

The support body of the vascular covered stent of the present application is provided with a through hole, and the connecting film can be penetrated through the through hole and surrounds the supporting body, which avoids placing the connecting film on the outer surface of the supporting body and causing the overall appearance of the vascular covered stent. Therefore, the diameter of the vascular stent graft of the present application is smaller, which is easier to place in the blood vessel, and the entire stent is more tightly integrated, making the vascular stent graft as a whole softer.

Claims (12)

A vascular stent graft, characterized in that it 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 membrane of the inner membrane. surface, the support 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 to the inner layer film. The stent graft of claim 1, wherein the support body is in a wavy curved shape; the support body includes a plurality of support units and a plurality of first curved sections, and the plurality of support units surround The axes of the inner membranes are spaced apart from each other, two adjacent support units are connected through one of the first curved sections, each support unit is provided with the through hole, and the connecting membrane passes through a plurality of first bending sections. the through hole of the support unit. The stent graft of claim 2, wherein each support unit includes a second curved section and two connecting sections, and two ends of the second curved section are respectively connected to the two connecting sections. , one end of the two connecting sections away from the second bending section is connected to the two first bending sections respectively, and the through hole penetrates a local section of the connecting section. The stent graft of claim 3, wherein the connection section includes a first section, a second section and a third section, and the second section is connected to the first section. and the third section, the first section is connected to the first curved section, the third section is connected to the second curved section, and the through hole is provided in the second section . The stent graft of claim 4, wherein the connection section includes a first surface and a second surface that are oppositely arranged, the first surface is close to the outer surface of the inner membrane, and the through-section The hole is located between the first surface and the second surface, and the height of the through hole along the direction perpendicular to the first surface and the second surface is less than or equal to the first surface and the second surface. 1/2 the vertical spacing of the surface. The stent graft of claim 5, wherein the length of the through hole along the length direction of the connecting section is 1/2 to 2/3 of the length of the connecting section. The stent graft of claim 1, wherein a plurality of through holes are provided in the support body, and the plurality of through holes are arranged at intervals along the axial direction of the inner membrane, so The support structure includes a plurality of connection films, each of which passes through a plurality of through holes and is arranged around the inner layer film. The vascular stent graft according to any one of claims 1 to 7, wherein the vascular stent graft includes a plurality of support structures, and the plurality of support structures are along the axis of the inner membrane. spaced apart from each other in the direction. The stent graft of claim 8, wherein the support body of the support structure is formed by a plurality of support units and a first curved section connected between two adjacent support units; at least one The number of supporting bodies of the supporting structure is different from the number of supporting bodies of other supporting structures; and/or, The spacing between at least two adjacent supporting structures is different from the spacing between other two adjacent supporting structures. The vascular stent graft according to claim 8, wherein the vascular stent graft further includes a plurality of connectors, and two adjacent support structures are connected by at least one connector; The connectors are straight, wavy, zigzag, square wave, waveform or Ω-shaped. A method for manufacturing the vascular stent graft according to any one of claims 1 to 10, characterized in that the manufacturing method includes: Provide the inner layer film and the connecting film, and perform surface treatment on the inner layer film and the connecting film; Provide a core rod, and put the inner film on the core rod; Provide the support body, insert the connection film from the through hole of the support body and surround the support body; put the support body with the connection film on the inner film the outer surface; Provide a pressurizing device, using the pressurizing device to wrap the outer surface of the support body; A heating box is provided, and the above combined structure is put into 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 stent graft. A stent graft delivery system, characterized in that the stent graft delivery system is used to deliver the vascular stent graft described in any one of 1 to 10 into the blood vessel, and the stent graft delivery system includes a connector , guidewire tube, catheter, balloon and developing ring, the connecting piece is provided with a guidewire cavity and a liquid-passing cavity, the guidewire tube and the catheter are connected to the connecting piece, so The guide wire tube is connected to the guide wire cavity, the liquid catheter tube is connected to the liquid conduction cavity, the guide wire tube is penetrated in the liquid catheter tube, and the end of the guide wire tube is connected to the liquid catheter cavity. The end of the catheter extends out, one end of the balloon is connected to the guidewire tube, the other end of the balloon is connected to the catheter, and the catheter is connected to the balloon, The developing ring is connected to the guidewire tube, and the vascular stent graft is installed on the balloon.