CN209107678U - Blood vessel covered stent - Google Patents

Abstract

The embodiment of the present utility model discloses a stent graft for blood vessels, comprising: a tubular support frame, which is connected as a whole and hollow to form an axial channel from the proximal end to the distal end, the tubular support frame can be bent in the axial direction telescopic; an insulating film covering at least part of the outer surface of the tubular support frame, the insulating film has a plurality of sets of connection points, and the insulating film is connected to the tubular support frame at the connection points; in a released state , the complete axial length of the insulating film between the adjacent two groups of connection points is greater than the axial length of the tubular support frame between the adjacent two groups of connection points. By adopting the utility model, the stent-graft for blood vessels has the advantages of taking into account both the radial support force and the overall flexibility.

Description

Vascular stent graft

technical field

The utility model relates to the technical field of medical devices, in particular to a blood vessel covered stent.

Background technique

Existing common vascular diseases generally include aortic aneurysm, aortic dissection and so on.

Aortic aneurysm refers to the local or diffuse abnormal expansion of the aortic wall, which compresses the surrounding organs and causes symptoms, and the aneurysm rupture is the main risk. Aortic aneurysm causes increased intravascular pressure, so it is progressively enlarged. If it develops for a long time, it will eventually rupture. The larger the aneurysm, the greater the possibility of rupture.

The human aortic blood vessel is composed of three layers: intima, media and adventitia. The three layers are closely attached and jointly carry the passage of blood flow. Aortic dissection refers to the partial tear of the intima, which is subjected to a strong blood impact, and the intima is gradually peeled off and expanded, forming a true and a false lumen in the artery. Aortic dissection is a cardiovascular disease that seriously threatens human life and health.

In order to treat vascular diseases such as aortic aneurysm or aortic dissection, micro-invasive interventional therapy technology based on the principle of endoluminal isolation is now used to treat vascular diseases. Arterial dissection. At present, the stent-graft on the market is mainly composed of a metal wire and an insulating film such as a PET (polyethylene terephthalate resin) film or an ePTFE (polytetrafluoroethylene) film covering it. A cylindrical stent skeleton is formed, the metal wires are separated from each other, and the insulating film is covered on it. Using a delivery system with a smaller diameter, the compressed stent-graft is guided along the pre-implanted guide wire into the human body. With the assistance of the imaging system, it is accurately released after reaching the position of the diseased blood vessel, covering the diseased blood vessel. Vascular segments, isolate lesions and form new blood flow channels, so as to achieve the purpose of curing vascular diseases.

At present, the insulating film of the stent-graft on the market is connected with the stent skeleton by complete heat pressing or suture. The metal wire provides radial support force, adjusts the distance between adjacent metal wires, and uses the insulating film itself. Flexibility adjusts the overall flexibility of the stent-graft. However, if the distance between adjacent wires is too small, the bending flexibility of the stent skeleton is poor because the wires are completely restricted by the insulating film; if the distance between adjacent wires is too large, The flexibility of the stent skeleton is improved, but the overall radial support force of the stent-graft will be insufficient, and the flexibility and radial support force of the existing stent-graft cannot be taken into account.

Utility model content

The technical problem to be solved by the embodiments of the present invention is to provide a stent-graft for blood vessels. The vascular stent graft can take into account both radial support force and overall flexibility.

In order to solve the above technical problems, the embodiment of the present invention provides a stent-graft for blood vessels, including:

A tubular support frame, which is connected as a whole and hollow to form an axial channel from the proximal end to the distal end, the tubular support frame can be bent and stretched in the axial direction;

an insulating film covering at least part of the outer surface of the tubular support frame, the insulating film has a plurality of groups of connection points, and the insulating film is connected to the tubular support frame at the connection points;

In the released state, the complete axial length of the insulating film between the adjacent two groups of connection points is greater than the axial length of the tubular support frame between the adjacent two groups of connection points.

In an embodiment of the present invention, the insulating film includes a connecting section and a telescopic section, the connecting section is a part of the insulating film having the connecting point, and the telescopic section is the isolation between two adjacent sets of connecting points membrane part.

In an embodiment of the present invention, the axial length of the connecting section is 2-20 mm.

In an embodiment of the present invention, the natural axial distance of the telescopic section is 10-60 mm.

In an embodiment of the present invention, the connecting section is a non-stretchable insulating film, and the telescopic section is a stretchable insulating film; or both the connecting section and the telescopic section are stretchable insulating films.

In an embodiment of the present invention, the ratio of the full axial length of the telescopic section to the natural axial distance of the telescopic section when the telescopic section is in a released state ranges from 1.01:1 to 1.5:1.

In an embodiment of the present invention, the telescopic segment forms folds in the axial direction.

In an embodiment of the present invention, the telescopic section is formed by repeated arrangement or sequential arrangement of a plurality of pleated units on an axial longitudinal section. One of the C types or a combination of at least two of them.

In an embodiment of the present invention, when the tubular support frame is radially compressed to a minimum inner diameter, the insulating film is stretched in the axial direction along with the extension of the tubular support frame.

In an embodiment of the present invention, the insulating film is a nylon insulating film, a polyester insulating film or a polytetrafluoroethylene insulating film.

In an embodiment of the present invention, the insulating film is a straight stretchable film at least in the expansion and contraction section.

In an embodiment of the present invention, the tubular support frame is surrounded by a network structure.

In an embodiment of the present invention, the network structure is formed by weaving metal wires or by cutting metal pipes.

In an embodiment of the present invention, the tubular support frame is formed by cutting a metal tube, and the tubular support frame is composed of multiple open-loop units and/or multiple closed-loop units.

In an embodiment of the present invention, the stent-graft for blood vessels further includes a bare stent, and the bare stent is formed by extending from the proximal end of the tubular support frame to the proximal end direction.

In an embodiment of the present invention, the stent-graft further includes barbs, and the barbs are disposed on the outer surface of the bare stent or the outer surface of the proximal end of the tubular support frame.

In an embodiment of the present invention, a part of the outer surface of the tubular support frame is not covered with the insulating film.

In an embodiment of the present invention, the insulating film completely covers the outer surface of the tubular support frame.

In an embodiment of the present invention, the tubular support frame is a self-expandable stent or a balloon-expandable stent.

In an embodiment of the present invention, the tubular support frame is in the form of a hollow cylinder or a truncated cone.

In an embodiment of the present invention, at the connection point, the insulating film and the tubular support frame are connected by sewing, gluing or heat pressing.

In an embodiment of the present invention, a developing device is provided at the proximal end or the distal end of the stent-graft.

Implementing the embodiment of the present utility model has the following beneficial effects:

The stent-graft includes: a tubular support, which is connected as a whole and hollow to form an axial channel from the proximal end to the distal end, the tubular support can be bent and stretched in the axial direction; an insulating membrane, which is covered on On the outer surface of at least part of the tubular support frame, there are multiple sets of connection points on the isolation film, and the isolation film is connected with the tubular support frame at the connection points; in the released state, the adjacent two groups are connected The complete axial length of the insulating membrane between the points is greater than the axial length of the tubular support frame between the adjacent two sets of connection points. Therefore, when the tubular support frame is stretched, since the complete axial length of the insulating film between the adjacent two groups of connection points is greater than the axial length of the tubular support frame between the adjacent two groups of connection points, the insulating film is very It is easy to be elongated, the insulating film will not block the extension of the tubular support frame, and the vascular covered stent has better bending flexibility; and since the tubular support frame is connected as a whole, it has better radial support force. Therefore, the stent-graft of the embodiment of the present invention not only has good flexibility, but also has good radial support force.

Description of drawings

In order to more clearly illustrate the embodiments of the present utility model or the technical solutions in the prior art, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description These are just some embodiments of the present invention, and for those of ordinary skill in the art, other drawings can also be obtained from these drawings without creative effort.

1 is a schematic diagram of the first embodiment of the present utility model when the stent-graft is in a released state;

Fig. 2 is another schematic diagram of the first embodiment of the present utility model when the stent-graft is in a released state (wherein the right half of Fig. 2 has removed the insulating film for clarity);

3 is a schematic diagram of the first embodiment of the present utility model when the tubular support frame is in a released state;

4 is a schematic diagram of the first embodiment of the present invention when the insulating film is in a released state;

5 is a schematic diagram of the first embodiment of the present invention when the insulating film is stretched to the longest axial length after being subjected to axial tension;

Fig. 6 is a schematic diagram of a stent graft according to the second embodiment of the present utility model (wherein the right half of Fig. 6 has removed the insulating film for the sake of clarity);

Fig. 7 is a schematic diagram of a stent-graft of the third embodiment of the present utility model (wherein the right half of Fig. 7 has removed the insulating film for the sake of clarity);

FIG. 8 is a schematic diagram of the stent-graft of the fourth embodiment of the present invention (wherein the right half of FIG. 8 has removed the insulating film for the sake of clarity);

FIG. 9 is a schematic diagram of a stent-graft for blood vessels according to a fifth embodiment of the present utility model (wherein the right half of FIG. 9 has removed the insulating film for clarity);

Icon label:

110, 210-tubular support frame; 111, 211-closed-loop unit; 112-mesh; 113-wire; 120, 520-insulation film; 121-connection point; 122-fold unit; segment; 213 - open loop unit; 330 - bare stent; 440 - barb.

Detailed ways

The technical solutions in the embodiments of the present utility model will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present utility model. Obviously, the described embodiments are only a part of the embodiments of the present utility model, rather than all the implementations. example. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present invention.

The appearances of the terms "comprising" and "having" and any variations thereof in the specification, claims and drawings of this application are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device comprising a series of steps or units is not limited to the listed steps or units, but optionally also includes unlisted steps or units, or optionally also includes For other steps or units inherent to these processes, methods, products or devices. In addition, the terms "first", "second", "third", etc. are used to distinguish different objects and not to describe a specific order.

For clarity of description, the end close to the heart position is hereinafter referred to as the proximal end, and the end away from the heart position is referred to as the distal end.

first embodiment

An embodiment of the present invention provides a stent-graft for blood vessels, please refer to FIG. 1 to FIG. 5 , the stent-graft for blood vessels includes a tubular support frame 110 and an isolation membrane 120 .

Referring to FIGS. 1-3 , in this embodiment, the tubular support frame 110 is connected as a whole, that is, the tubular support frame 110 is not separated and independent, and there will be no independent parts. When the user stretches the tubular support 110 at the proximal end or the distal end of the tubular support 110 (the other end is fixed), the tubular support 110 is stretched together as a whole, that is, the tubular support 110 Each part contributes to the elongation of the tubular support frame 110. When the user compresses the tubular support frame 110 at the proximal end or the distal end of the tubular support frame 110 (the other end is fixed), the tubular support frame 110 is compressed as a whole, That is, each part of the tubular support frame 110 contributes to the shortening of the tubular support frame 110 .

In this embodiment, the tubular support frame 110 is hollow to form an axial channel (not shown in the figure) from the proximal end to the distal end, and the axial channel is similar to the blood flow channel in a human blood vessel. The axial channel is used to transport blood when the stent-graft is located in a blood vessel. The tubular support frame 110 can be bent and stretched in the axial direction.

Specifically, in this embodiment, the tubular support frame 110 is made of a shape memory alloy material, such as nickel-titanium alloy, copper-nickel alloy, copper-aluminum alloy, copper-zinc alloy, etc. When the tubular support frame 110 is placed in the blood vessel, the tubular support frame 110 can bend and expand according to the bending of the blood vessel. Specifically, when the tubular support frame 110 is bent, the inner corresponding area of the tubular support frame 110 will be squeezed and compressed, and the outer corresponding area of the tubular support frame 110 will be stretched. In addition, in other embodiments of the present invention, the tubular support frame can also be made of stainless steel, cobalt-chromium alloy or other materials with good biocompatibility, and the radial support force of the tubular support frame is better at this time. , and the tubular support frame can also bend and expand with the bending of the blood vessel.

Referring to FIGS. 1 , 2 , 4 , and 5 , in this embodiment, the insulating film 120 covers at least part of the outer surface of the tubular support frame 110 , and in this embodiment, the insulating film 120 completely covers The outer surface of the tubular support frame 110 . Of course, in other embodiments of the present invention, the insulating film may not completely cover the tubular support frame. In this embodiment, the insulating film 120 has multiple groups of connection points 121, and five groups of connection points 121 are provided from the proximal end to the distal end in the figure, and the adjacent connection points 121 in the same group may be discontinuous or intermittent. is continuous, the insulating film 120 is connected to the tubular support frame 110 at the connection point 121, and the insulating film 120 is not connected to the tubular support frame 110 at other positions, so that the connection point 121 of the insulating film 120 is connected to the tubular support frame 110. The position of the tubular support frame 110 is relatively fixed. In this embodiment, each group of the connection points 121 is located on the circumference of the same circle. However, the present invention is not limited to this. In other embodiments of the present invention, each group of the connection points may be located on the circumference of the same ellipse, or the like. In order to prevent the isolation membrane 120 from restricting the axial expansibility of the tubular support frame 110 as in the prior art, in this embodiment, in the released state of the stent graft, the isolation between the adjacent two groups of connection points 121 The complete axial length of the membrane 120 is greater than the axial length of the tubular support frame 110 between the adjacent two groups of connection points 121. Here, the stent-graft release state refers to the state of the stent-graft in its natural state, At this time, no external force is applied, and the complete axial length of the insulating film 120 refers to the longest axial length that the insulating film itself can expand after being subjected to axial tension (see FIG. 5 ). When the insulating film 120 itself has elasticity, it can When stretched, the complete axial length of the insulating film 120 includes the axial length increased by elastic elongation. When the insulating film 120 itself does not have elastic stretchability, the complete axial length of the insulating film 120 is the insulating film. Axial length after fully unfolded; the axial length of the tubular support frame 110 is the natural axial length when no force is applied in the released state, so the insulating film 120 can be stretched with the bending of the support frame without binding or restricting Bending of the support frame. Correspondingly, the natural axial distance of the isolation membrane 120 refers to the axial distance between the proximal end and the distal end when no force is applied in the released state. Therefore, when the tubular support frame 110 is stretched, the insulating film 120 will be subjected to tensile force through the connection points, because the complete axial length of the insulating film 120 between the two adjacent sets of connection points 121 is greater than that between the adjacent two groups of connection points 121 The axial length of the tubular support frame 110 between the two, so that the insulating film 120 is easily stretched, and the insulating film 120 will not block the extension of the tubular support frame 110, so that the bending flexibility of the stent-graft is better; and , since the tubular support frame 110 is connected as a whole, it has better radial support force. Therefore, the stent-graft of the embodiment of the present invention not only has good flexibility, but also has good radial support force.

When a vascular disease such as aneurysm or arterial dissection occurs in the user's blood vessel, the doctor compresses the above-mentioned vascular stent-graft into the interventional delivery system, and the vascular stent-graft is guided along the pre-implanted guide wire into the blood vessel. Specify the location (the location of vascular lesions), then release the vascular stent-graft, after the release the vascular stent-graft expands, and bends with the human blood vessel, the vascular stent-graft covers the diseased blood vessel segment, isolating lesions and new vascular channels are formed. For an aneurysm, after the blood supply is lost, the residual blood in the aneurysm gradually forms a thrombus and muscleizes to form vascular tissue. The expanded aneurysm wall shrinks due to negative pressure and gradually returns to its original shape, thereby achieving the purpose of treating aneurysm. . For aortic dissection, the vascular stent-graft covers the aortic dissection rupture, the false lumen is gradually thrombosed, and the negative pressure is gradually reduced, so as to achieve the purpose of treating aortic dissection.

1-3, in this embodiment, the tubular support frame 110 is a hollow cylindrical shape, that is, a cylindrical shape. Of course, in other embodiments of the present invention, the tubular support frame 110 is a hollow cylindrical shape. It can also be other structures, such as truncated cone shape and the like. In this embodiment, the tubular support frame 110 is surrounded by a network structure, and the axial channel is formed in the middle. The network structure is similar to the structure of a fishing net, and the radial support force of this structure is better. Moreover, When the stent-graft is bent, the insulating membrane 120 outside the tubular support frame 110 will not protrude into the axial channel, so that the inner diameter of the axial channel will not decrease, that is, the axial direction of the stent-graft everywhere The inner diameters of the channels are almost the same, and when blood flows in the axial channel, the stent-graft will not suffer a large blood flow shock due to the insulator membrane 120 protruding into the axial channel, so that the stent-graft is not affected by the existing blood flow. In this way, the stent-graft will not be displaced due to the reduction of the inner diameter of the channel, causing the stent-graft to withstand a large blood flow shock pressure, so that the stent-graft in this embodiment is accurately placed in the blood vessel. It is not easy to be displaced, and the vascular covered stent according to the embodiment of the present invention has a better effect on the treatment of vascular diseases. In addition, in other embodiments of the present invention, the tubular support frame may also be surrounded by a frame-like structure, or a combination of a network-like structure and a frame-like structure.

Specifically, the network structure includes a plurality of closed-loop units 111. In this embodiment, the closed-loop units 111 are formed by four metal edges connected end to end to form a closed rhombus, and each closed-loop unit 111 is hollow to form a mesh. 112. In this embodiment, the line connecting a pair of opposite vertices of the diamond-shaped closed-loop unit 111 extends in the axial direction. Please refer to the upper and lower vertices of the diamond-shaped closed-loop unit 111 in FIG. 2 and FIG. 3 . When the tubular support frame 110 is stretched , the upper and lower vertices of the diamond-shaped closed-loop unit 111 are easily elongated, and the distance between the left and right vertices of the diamond-shaped closed-loop unit 111 is reduced, that is, the diamond-shaped closed-loop unit 111 is easily crushed, so that the bending flexibility of the tubular support frame 110 is relatively high. it is good. In this embodiment, the closed-loop unit 111 has a regular shape, but is not limited to a rhombus, for example, a circle, an ellipse, a convex polygon, and the like. In this embodiment, a plurality of mesh holes 112 are formed on the network structure, each closed-loop unit 111 corresponds to a hollow mesh hole 112 , and the shape of the mesh hole 112 corresponds to the shape of the closed-loop unit 111 .

In this embodiment, the network structure is formed by weaving metal wires 113. In this embodiment, the metal wires 113 can be made of a shape memory alloy material, but the present invention is not limited to this, in other aspects of the present invention In an embodiment, the metal wire may also be stainless steel, cobalt-chromium alloy or other materials with good biocompatibility. A network structure is formed by weaving the metal wires 113. The metal wires 113 used for weaving can be one strand or multiple strands. When all the metal wires 113 used for weaving are one strand, the metal wires 113 are relatively thick. At this time, the radial support force of the tubular support frame 110 is relatively good, and the flexibility is slightly poor. When the metal wires 113 used for weaving include multiple strands, each metal wire 113 is relatively thin, and the braiding formed at this time. The radial support force of the tubular support frame 110 is slightly worse, but the flexibility is good. Of course, the metal wire 113 used for weaving can also be partially single-strand and partially multi-strand. At this time, both the radial support force and the flexibility can be taken into account. , which can be changed according to actual needs. In addition, in other embodiments of the present invention, the network structure can also be formed by cutting a metal pipe, specifically, digging out the metal where the mesh holes are to be formed on the metal pipe. In this embodiment, the braiding manner of the metal wires 113 may be winding, knotting, etc. to connect the two metal wires 113 together. In this embodiment, the tubular support frame 110 is made of shape memory alloy, so that the tubular support frame 110 is a self-expanding stent, that is, when the compressed stent-graft is released, the The tubular support frame 110 is automatically expanded to form the axial channel without external force intervention.

Referring to FIG. 1 , FIG. 2 , FIG. 4 and FIG. 5 , in this embodiment, the insulating film 120 includes a connecting section 123 and a telescopic section 124 . In the figure, the number of connecting sections 123 is 5, and the telescopic section 124 The number is 4, of course, the number of connecting sections and telescopic sections of the present invention is not limited to this. In this embodiment, the connecting section 123 is a part of the insulating film 120 having the connecting point. Here, the connecting section 123 is straight, and the connecting section 123 is a non-stretchable insulating film. The telescopic section 124 is a part of the insulating film 120 between the adjacent two groups of connection points, that is, between the two adjacent connection sections 123. The telescopic section 124 is not straight, and the telescopic section 124 is undulating up and down. Here, the telescopic section 124 forms folds, and the telescopic section 124 is a telescopic insulating film. Of course, in other embodiments of the present invention, the telescopic section can also undulate up and down to form an irregular shape. In addition, in other embodiments of the present invention, the connecting section may also be a retractable insulating film, in which case both the retractable section and the connecting section are retractable insulating films, and the connecting section also undulates up and down. In addition, in other embodiments of the present invention, the insulating film is a straight stretchable film at least in the telescopic section, at this time, the telescopic section can be elastically elongated, and at this time, the complete axial direction of the telescopic section The length is the axial length of the telescopic section after being elastically elongated.

In this embodiment, the axial length of the connecting section 123 is 2mm-20mm, for example, 2mm, 4mm, 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, etc. The connecting point may be located at any The axial center of the connecting segment 123 may not be located at the axial center of the connecting segment 123 . In this embodiment, the natural axial distance of the telescopic section 124 is 10mm-60mm, for example, 10mm, 20mm, 30mm, 40mm, 50mm, 60mm, and the like. In this embodiment, the ratio of the full axial length of the telescopic section 124 to the natural axial distance of the telescopic section 124 in the released state ranges from 1.01:1 to 1.5:1, for example, 1.01:1, 1.05:1, 1.1:1, 1.2:1, 1.3:1, 1.4:1, 1.5:1.

In this embodiment, the insulating film 120 is cylindrical as a whole, and the insulating film 120 completely covers the outer surface of the tubular support frame 110 . In this embodiment, the insulating film 120 is an insulating film made of a high biocompatibility material such as a nylon insulating film, a polyester insulating film, or a polytetrafluoroethylene insulating film, and the insulating film 120 itself does not have stretchability. sex. In addition, in other embodiments of the present invention, the insulating film itself can also be made of materials with elastic stretchability, in which case the telescopic section and the connecting section are both straight, and both the telescopic section and the connecting section are It is a stretchable insulating film, or, the connecting section is a straight non-stretchable insulating film, and only the telescopic section is a stretchable insulating film. In this embodiment, the isolating membrane 120 can be made by high-density weaving or other processes, and has small porosity and anti-stretching properties, which can effectively prevent blood leakage and rebuild blood flow channels. In this embodiment, the insulating film 120 may be a single layer or a multi-layer.

In this embodiment, the insulating film 120 is connected to the tubular support frame 110 at the connection point 121 by a sewing process. The sutures are, for example, polyester sutures, polypropylene sutures, polytetrafluoroethylene sutures or other sutures with good biocompatibility. The connection is relatively stable and not easy to detach. In this embodiment, the same group of connection points 121 are sutured by the same suture thread, which is beneficial to improve the connection efficiency. In addition, in other embodiments of the present invention, the insulating film may also be adhered to the corresponding position of the tubular support frame through an adhesive at the connection point. In addition, in other embodiments of the present invention, the insulating film can also be connected together by thermocompression at the connection point.

In this embodiment, the part of the insulating film 121 where the same set of connection points 121 is located forms a circle of straight rings, that is, the connecting section 123 is annular and straight, which is beneficial for the insulating film 120 to better support the tubular shape Stable connection of rack 110. In this embodiment, the telescopic section 124 is wavy in the axial longitudinal section. Specifically, the telescopic section 124 is formed by a plurality of pleated units 122 arranged repeatedly or sequentially in the axial longitudinal section, so The pleated unit 122 is one of an inverted V shape, an inverted U shape, an Ω shape, an S shape, and a C shape, or a combination of at least two of them. Of course, in other embodiments of the present invention, the telescopic segment may also have other shapes. The pleat unit 122 can be unfolded when subjected to axial tension, and elongated in the axial direction until it is in a straight state. Axial length (see Figure 5). In other embodiments of the present invention, there may be a straight portion between two adjacent pleated units, which is beneficial to the connection of the two. In addition, in other embodiments of the present invention, the telescopic section may have only one wrinkle unit on the axial longitudinal section.

In this embodiment, when the tubular support frame 110 is radially compressed, the tubular support frame 110 is elongated in the axial direction at this time, and the tubular support frame 110 pulls the insulating film through the connection with the insulating film 120 . 120 is elongated in the axial direction. When the tubular support frame 110 is radially compressed to the minimum, the insulating film 120 is stretched in the axial direction along with the extension of the tubular support frame 110. The length is the full axial length. At this time, the diameter of the vascular stent-graft is small, which is convenient for the vascular stent-graft to be placed in the interventional delivery system, and the diameter of the sheath tube of the interventional delivery system can also be designed to be relatively small, which is convenient for the interventional delivery system to enter the blood vessel. middle.

After the stent-graft is placed into the blood vessel through the interventional delivery system, in order to timely know whether the placement of the stent-graft is accurate, a developing device is provided at the proximal end or the distal end of the stent-graft. In this embodiment, the developing device is a developing ring (not shown in the figure), the developing ring is sleeved on the proximal end or the distal end of the tubular support frame 110, and the developing ring is, for example, a tantalum wire ring, Platinum rings, gold rings, etc., when irradiated by X-rays, the developing ring can be identified, so that it can be accurately identified whether the position of the developing device in the blood vessel is accurate. Moreover, the developing ring in this embodiment can It is better connected to the vascular stent graft. In addition, in other embodiments of the present invention, the developing ring can also be sewed on the tubular support frame or the isolation film by a sewing process. In addition, in other embodiments of the present invention, the developing device is not limited to the developing ring, but may also have other structures. In addition, in other embodiments of the present invention, the material of the developing device is not limited to tantalum, platinum and gold, and may also be other materials known to those of ordinary skill in the art that can be identified by X-rays.

Second Embodiment

Fig. 6 is a schematic diagram of a stent graft according to the second embodiment of the present invention. The structure of Fig. 6 is similar to the structure of Fig. 2, so the same component symbols represent the same components. The difference is the tubular support frame.

Referring to FIG. 6 , in this embodiment, the tubular support frame 210 is formed by cutting a metal tube, specifically, formed by a laser cutting process. In this embodiment, the tubular support frame 210 is connected as a whole, and the tubular support frame 210 is composed of a plurality of open-loop units 213 and a plurality of closed-loop units 211 connected together, and the open-loop units 213 can be connected with the open-loop units 213 are connected to each other, and the open-loop unit 213 can also be connected to the closed-loop unit 211. Similarly, the closed-loop unit 211 and the closed-loop unit 211 can be connected to each other, and the closed-loop unit 211 can also be connected to the open-loop unit 213. Both the open-loop unit 213 and the closed-loop unit 211 are hollow to form mesh holes 112 . In this embodiment, the open-loop unit 213 refers to a ring structure that is not completely closed. The open-loop unit 213 is opposite to the closed-loop unit 211, and the two open-loop units 213 can be combined to form one The closed-loop unit 211 refers to a completely closed annular structure, that is, the edges of the closed-loop unit 211 are connected end to end to form a closed structure, and the closed-loop unit 211 is in the shape of a circle, an ellipse, a convex polygon, and the like. Referring to FIG. 6 , in FIG. 6 , the open-loop unit 213 refers to a structure not enclosed by four sides, and the closed-loop unit 211 refers to a structure enclosed by four sides. In addition, in other embodiments of the present invention, the tubular support frame may also be composed of only a plurality of open-loop units, and in this case, the tubular support frame has better flexibility. In addition, in other embodiments of the present invention, the tubular support frame may be composed of only a plurality of closed-loop units, and in this case, the radial support of the tubular support frame is better.

In this embodiment, the tubular support frame 210 is made of a shape memory alloy material. When the stent-graft comes out of the interventional delivery pipeline, the stent-graft can expand by itself, that is, the stent-graft The tubular stent 210 is a self-expanding stent. However, the present invention is not limited thereto. In other embodiments of the present invention, the tubular support frame may also be made of materials other than shape memory alloys. After the stent-graft is compressed into the interventional delivery system, After the release, the stent-graft will not expand by itself. At this time, by inflating the balloon placed inside the stent-graft, the stent-graft is stretched through balloon expansion, and then the balloon is taken out and expanded. The opened stent-graft utilizes the plastic deformation of the metal stent, and the stent-graft maintains its expanded shape to ensure smooth blood flow, that is, the stent-graft is a balloon-expandable stent. The tubular stent is composed of a plurality of open-loop units and a plurality of closed-loop units. Although the stent-graft is a balloon-expandable stent, it has a certain expansion and contraction ability in the axial direction.

Third Embodiment

Fig. 7 is a schematic diagram of a stent graft according to the third embodiment of the present invention. The structure of Fig. 7 is similar to that of Fig. 2, so the same component symbols represent the same components. The difference is that the stent-graft also includes a bare stent.

Referring to FIG. 7 , in this embodiment, the stent-graft further includes a bare stent 330 , the bare stent 330 is formed by extending from the proximal end of the tubular support frame 110 to the proximal direction, the bare stent 330 Bell-shaped. In this embodiment, the outer side of the bare stent 330 is not covered with the insulating film 120 . By including the bare stent 330, the stent-graft of this embodiment can increase the anchoring area at the proximal end of the stent-graft, especially for the case where the proximal end of the aortic lesion is close to or invades branch arteries, resulting in insufficient anchoring area. A ring of bare stent 330 is added at the end to provide more anchoring areas, and at the same time, the bare stent 330 will not block the patency of the blood flow of the branch blood vessels.

In other embodiments of the present invention, barbs are provided on the outer surface of the bare stent, and the number of the barbs is multiple. When the stent-graft is placed in the blood vessel, the barbs are By piercing into the blood vessel wall, the position of the blood vessel covered stent in the blood vessel can be stabilized, and the blood vessel covered stent is not easy to move. Here, the barbs are towards the distal end, and the lengths of the barbs are in the range of 0.5mm-4mm, such as 0.5mm, 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 4mm, and the like.

Fourth Embodiment

Fig. 8 is a schematic diagram of a stent graft according to the fourth embodiment of the present invention. The structure of Fig. 8 is similar to that of Fig. 2, so the same component symbols represent the same components. The difference is that the stent-graft further includes barbs.

Referring to FIG. 8 , in this embodiment, the outer surface of the proximal end of the tubular support frame 110 is provided with barbs 440 , the number of the barbs 440 is multiple, and the plurality of the barbs 440 are located in a circle On the circumference of , the barbs 440 are made of the same material as the tubular support frame 110 , the barbs 440 pass through the insulating film 120 on the outer side of the tubular support frame 110 , and the barbs 440 face the distal end. When the stent-graft is placed in the blood vessel, the barbs 440 penetrate into the blood vessel wall, so that the position of the stent-graft in the blood vessel can be stabilized, and the stent-graft is not easy to move.

Fifth Embodiment

Fig. 9 is a schematic diagram of a stent graft according to the fifth embodiment of the present invention. The structure of Fig. 9 is similar to the structure of Fig. 7, so the same component symbols represent the same components. The difference is that the insulating film does not completely cover the tubular scaffold. In addition, the braiding methods of the two support frames 110 are also different. In FIG. 9 , the support frame is formed by hand weaving, and in FIG. 7 , a braiding machine can be used.

Referring to FIG. 9 , in this embodiment, the insulating film 520 does not completely cover the tubular support frame 110 , that is, a part of the outer surface of the tubular support frame 110 does not have the insulating film 520 . When the stent-graft is located in the blood vessel, it can cross the branch blood vessels. At this time, the stent-graft covered with the insulating film 520 can play the role of reconstructing the blood flow channel. The part of the stent-graft not covered with the insulating film 520 faces the For the branch blood vessel, the blood in the stent-graft can flow into the branch blood vessel without affecting the blood supply of the branch blood vessel.

In addition, in this embodiment, the tubular support frame 110 is surrounded by a network structure, and the network structure is formed by braiding the metal wires 113 . Specifically, in this embodiment, the braiding method of the metal wires 113 is as follows: The two wires 113 are connected together by knotting.

It should be noted that, each embodiment in this specification is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. For the same and similar parts of each embodiment, refer to each other. Can. As for the apparatus embodiment, since it is basically similar to the method embodiment, the description is relatively simple, and reference may be made to the partial description of the method embodiment for related parts.

The above disclosures are only the preferred embodiments of the present invention, and of course, the scope of the rights of the present invention cannot be limited by this. Therefore, the equivalent changes made according to the claims of the present invention still belong to the scope covered by the present invention.

Claims (22)

1. a stent-graft, characterized in that, comprising: A tubular support frame, which is connected as a whole and hollow to form an axial channel from the proximal end to the distal end, the tubular support frame can be bent and stretched in the axial direction; an insulating film covering at least part of the outer surface of the tubular support frame, the insulating film has a plurality of groups of connection points, and the insulating film is connected to the tubular support frame at the connection points; In the released state, the complete axial length of the insulating film between the adjacent two groups of connection points is greater than the axial length of the tubular support frame between the adjacent two groups of connection points. 2 . The stent-graft according to claim 1 , wherein the insulating membrane comprises a connecting section and a telescopic section, the connecting section is a part of the insulating membrane having the connecting point, and the expanding section is a phase with the connecting point. 3 . The part of the insulating film between adjacent two sets of connection points. 3 . The stent-graft according to claim 2 , wherein the axial length of the connecting section is 2-20 mm. 4 . 4 . The stent graft according to claim 2 , wherein the natural axial distance of the telescopic segment is 10-60 mm. 5 . 5. The stent-graft of claim 2, wherein the connecting section is a non-stretchable insulating membrane, and the telescopic section is a stretchable insulating membrane; Alternatively, both the connecting section and the telescopic section are stretchable insulating films. 6 . The stent graft according to claim 2 , wherein the ratio of the full axial length of the telescopic segment to its natural axial distance when the telescopic segment is in a released state is in the range of 1.01:1- 1.5:1. 7 . The stent graft according to claim 2 , wherein the telescopic segment forms folds in the axial direction. 8 . 8 . The stent graft according to claim 7 , wherein the telescopic section is formed by repeated arrangement or sequential arrangement of a plurality of pleated units in an axial longitudinal section, and the pleated units are in an inverted V shape, an inverted V shape, and an inverted V shape. One of U-type, Ω-type, S-type and C-type or a combination of at least two of them. 9 . The stent graft of claim 1 , wherein when the tubular support is radially compressed to a minimum inner diameter, the insulating membrane is straightened in the axial direction along with the extension of the tubular support. 10 . 10 . The stent-graft of claim 1 , wherein the insulating film is a nylon insulating film, a polyester insulating film or a polytetrafluoroethylene insulating film. 11 . 11 . The stent graft according to claim 2 , wherein the insulating membrane is a straight stretchable membrane at least in the expansion and contraction section. 12 . 12 . The stent-graft of claim 1 , wherein the tubular support frame is surrounded by a network structure. 13 . 13 . The stent graft according to claim 12 , wherein the network structure is formed by weaving a metal wire or by cutting a metal tube. 14 . 14. The stent graft according to claim 1, wherein the tubular support frame is formed by cutting a metal tube, and the tubular support frame is composed of a plurality of open-loop units and/or a plurality of closed-loop units. 15. The stent-graft according to any one of claims 1-14, wherein the stent-graft further comprises a bare stent, and the bare stent extends from the proximal end of the tubular support frame to the proximal end direction extension. 16. The stent-graft of claim 15, wherein the stent-graft further comprises barbs, and the barbs are disposed on the outer surface of the bare stent or the outer surface of the proximal end of the tubular support frame . 17. The stent-graft according to any one of claims 1-14, wherein a part of the outer surface of the tubular support frame is not covered with the insulating membrane. 18. The stent-graft according to any one of claims 1-14, wherein the insulating film completely covers the outer surface of the tubular support. 19. The stent-graft according to any one of claims 1-14, wherein the tubular support is a self-expanding stent or a balloon-expanding stent. 20. The stent-graft according to any one of claims 1-14, wherein the tubular support is in the form of a hollow cylindrical shape or a truncated cone shape. 21. The stent-graft according to any one of claims 1-14, characterized in that, at the connection point, the insulating film and the tubular support frame are sutured, glued or heat-pressed to connect the two parts together. to connect. 22. The stent-graft according to any one of claims 1-14, wherein a developing device is provided at the proximal end or the distal end of the stent-graft.