WO2021129286A1

WO2021129286A1 - Covered stent system and covered stent thereof

Info

Publication number: WO2021129286A1
Application number: PCT/CN2020/131485
Authority: WO
Inventors: 王永胜; 李安伟
Original assignee: 杭州唯强医疗科技有限公司
Priority date: 2019-12-23
Filing date: 2020-11-25
Publication date: 2021-07-01

Abstract

The present invention provides a covered stent, comprising a tubular skeleton, a covering membrane, and a connecting member, the connecting member being disposed on the tubular skeleton or the covering membrane, and the connecting member is passed through by a control guide wire to control the radial contraction or expansion of the tubular skeleton. The present invention solves the technical problem that the covered stent cannot be accurately released on an appropriate position of the inner wall of a lumen for one time.

Description

Covered stent system and covered stent

The present invention claims the priority of prior applications of the application numbers 201911341650.1 and 201922337203.0 filed on December 23, 2019 under the name "Stent graft system and its stent graft". The content of the foregoing prior application is incorporated herein by way of introduction. In this.

Technical field

The invention relates to the field of medical equipment, and in particular to a stent graft system and a stent graft.

Background technique

Intracavitary repair of the chest and abdomen is an effective treatment option that has gained tremendous popularity in the past decade. However, for some challenging anatomical structures, such as anatomical structures with many branch vessels and highly curved or tortuous structures, there is still no suitable stent system for surgeons to use. Therefore, when the surgeon manipulates and deploys the stent, it is often necessary to adjust the position of the release stent until the stent is at the optimal release point, so that the blood can flow normally and the stent can work evenly on the wall.

Most aortic aneurysms occur in the abdominal aorta, and the main cause is arteriosclerosis. In my country, according to incomplete statistics, the incidence of abdominal aortic aneurysms in 2005 was 3‰-6.6‰. In the past 30 years, the incidence has increased three times. The normal diameter of the abdominal aorta is about 1 inch. Once the diameter of the aortic aneurysm reaches 5 cm, it is generally believed that it needs to be treated to prevent rupture. The aneurysm area of the aorta can be bypassed for treatment by using a tubular exclusion device delivered by the lumen, for example, by occluding the aneurysm by a stent placed in a blood vessel that spans the aneurysm portion of the blood vessel. The specific operation is to pre-load the stent graft into the sending device, intervene into the diseased part of the abdominal aorta through the femoral artery, and accurately release the stent on the diseased part under the supervision of the X-ray fluoroscopy equipment.

The pathological feature of abdominal aortic aneurysm is that the wall of the abdominal aorta is less elastic, the diameter of the abdominal aorta gradually increases and exceeds 1.5 times the normal diameter, the blood flow is large, and the stent anchoring is unstable and it is prone to displacement. The abdominal aorta provides two lateral blood vessels leading to the kidney, the renal artery. Below the level of the renal artery, the abdominal aorta reaches approximately the level of the fourth lumbar vertebra (or umbilicus) into the ileal artery, which then supplies blood to the lower extremity and perineal area. With so many branches of the physiological structure, the stent can easily block the shunt. Therefore, in the treatment of abdominal aortic aneurysm, if the stent is not stable, it will cause the stent graft to block blood flow and even block the renal artery flowing through the abdominal aorta, causing serious consequences.

Summary of the invention

The purpose of the present invention is to provide a stent graft system and a stent graft to solve the technical problem that the stent graft cannot be accurately released at a proper position on the inner wall of the lumen at one time, which will cause the stent graft to block blood flow.

The present invention provides a stent graft, comprising: a tubular skeleton, a covering film fixed on the tubular skeleton, and a connecting piece, the connecting piece being arranged on the tubular skeleton or the covering film, the connecting piece The member is used for the control guide wire to pass through, so as to control the radial contraction or expansion of the tubular skeleton.

Wherein, the connecting member is fixedly connected to the covering film and/or the tubular skeleton by stitching, heat sealing or welding.

Wherein, the connecting member is a through-hole structure on the tubular frame or/and the covering film.

Wherein, the connecting member is arranged at least one circle around the stent graft.

Wherein, the tubular frame includes a plurality of annular support frames arranged at intervals along the axial direction, the ring support frame is a wave-shaped ring support frame formed by metal rods connected end to end, and the ring support frame includes wave crests, wave troughs, and Poles; the annular support frame includes a first-layer annular support frame, the first-layer annular support frame is provided with barbs on at least one of the troughs, and the included angle between the barbs and the trough is α, 0° ＜α＜90°.

Wherein, the first-layer ring-shaped support frame is located at the beginning section of the proximal end of the tubular skeleton, partially sutured on the inner surface of the covering film, and the barbs pass through the covering film and are exposed outside the covering film.

Wherein, the annular support frame further includes a second-layer annular support frame, and the positions of the wave crests and troughs of the second-layer annular support frame are respectively arranged in one-to-one axial correspondence with the positions of the wave crests and wave valleys of the first-layer annular support frame. , The axial distance between the wave trough of the first layer of the annular support frame and the starting section of the proximal end of the film is not more than 10 mm.

Wherein, the tubular frame further includes a plurality of branched annular support frames, and the axial distance between the troughs of the second-layer annular support frame and the first-layer annular support frame is smaller than the wave height of the second-layer annular support frame.

Wherein, the wire diameter of the second-layer ring-shaped support frame is 10 to 70% smaller than that of other ring-shaped support frames.

The present invention provides a stent graft system, including the above-mentioned stent graft.

Wherein, the stent graft system further includes a conveyor, the conveyor includes a control guide wire and a conveyor tip, the control guide wire passes through the connector to control the radial contraction or expansion of the tubular skeleton The proximal end of the conveyor tip includes a fixed portion facing the direction of the operating handle, at least one channel is provided on the fixed portion, and the fixed portion is located on a plane formed by the connecting piece facing the end of the conveyor The side or the proximal end on the plane formed by the connector.

Wherein, the control guide wire is detachably connected to the channel.

Wherein, the fixing part is provided with two channels, the two ends of the control guide wire respectively pass through the two channels, and the control guide wire is used to remove the stent graft after the release of the stent graft is completed. The channel is withdrawn.

Wherein, the fixing portion includes a fixing wire groove and a channel, the fixing wire groove is provided with a fixing wire, the fixing wire groove is provided with a fixing wire, when one end of the fixing wire is connected to the fixing wire groove When the groove walls of the abutting, one end of the control guide wire is fixed by the fixed wire, the other end of the control guide wire passes through the channel, and the control guide wire and the fixed wire are used for covering the covering After the release of the membrane stent is finished, it is withdrawn from the fixing wire groove.

In summary, when the guide wire is controlled to control the radial expansion of the tubular skeleton, the stent graft can be released in multiple steps through the control of the guide wire, so that the stent graft can be repeatedly tightened and expanded to seal the aorta. The wall is firmly fixed on the aorta. After expansion, the stent graft does not cover or occlude the key branch arteries, and the space in the expanded stent graft provides a flow channel for blood to flow through the aneurysm. When the control guide wire controls the contraction of the tubular skeleton, the stent graft can be tightened in multiple steps through the control of the control guide wire, and the tightened stent graft can smoothly enter the aortic cavity under the transport of the conveyor.

Description of the drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

Fig. 1 is a schematic diagram of the structure of the stent graft system provided by the present invention.

FIG. 2 is a schematic diagram of an enlarged structure of part A in FIG. 1.

Fig. 3 is a schematic top view of the structure of part A in Fig. 1.

Fig. 4 is a schematic diagram of the structure of the tubular skeleton in Fig. 1.

Fig. 5 is a schematic diagram of an enlarged structure of part A1 in Fig. 2.

Fig. 6 is a schematic diagram of another enlarged structure of part A in Fig. 1.

FIG. 7 is a schematic diagram of an enlarged structure of part A1 in FIG. 6.

Detailed ways

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

It should be noted that for vascular stents, the end near the heart after implantation of the blood vessel is generally called the "proximal end" of the stent, and the end far away from the heart after the implantation of the blood vessel is called the "distal end" of the stent, and according to this principle Define the "proximal" and "distal" of any component of the stent. For the conveyor, the end of the conveyor closer to the operator is generally called the "proximal end", and the end of the conveyor farther from the operator is called the "distal", and the delivery system is defined according to this principle. The "proximal" and "distal" parts of a component. "Axial" generally refers to the length direction of the stent when it is delivered, and "radial" generally refers to the direction perpendicular to the "axial direction" of the stent, and the "axial direction" of any component of the stent graft is defined according to this principle. "And "radial".

Please refer to FIG. 1, the present invention provides a stent graft system, including the stent graft 100 and a conveyor 200. The conveyor 200 is used to deliver the stent graft 100 to a diseased site and can be repeatedly tightened and expanded. The stent 100 adjusts the implantation position of the stent graft 100, so that the stent graft 100 can accurately release the appropriate position in the blood vessel cavity, thereby realizing the therapeutic function of the stent graft 100 in the cavity. The stent graft 100 will be described in detail as follows.

Please refer to FIGS. 2 to 3 together. The stent graft 100 includes a tubular skeleton 10, a covering membrane 20 fixed on the tubular skeleton 10, and a connecting piece 30. The connecting piece 30 is provided on the tubular skeleton 10 or the covering membrane 20. The connecting member 30 is passed through by the control guide wire 40 to control the radial contraction or expansion of the tubular skeleton 10. In a specific embodiment, the covering film 20 is sleeved on the tubular frame 10 and fixed on the tubular frame 10, and there are a plurality of connecting members 30. Preferably, a plurality of connecting members 30 are arranged circumferentially, and the control guide wire 40 passes through each connecting member 30 sequentially in the circumferential direction. The control guide wire 40 will be described later.

In a specific embodiment, the connecting member 30 is a through-hole structure 301 on the tubular frame 10 or/and the covering film 20. The control guide wire 40 sequentially passes through the plurality of through-hole structures 301 to control the radial contraction or expansion of the tubular skeleton 10. In this embodiment, the control guide wire 40 passes through the through hole structure 301 sequentially in the circumferential direction.

In another specific embodiment, the connecting member 30 is a separate structure, the connecting member 30 is fixedly connected to the tubular frame 10 or the covering film 20, and each connecting member 30 has a through-hole structure 301. In this embodiment, the control guide wire 40 sequentially passes through the through hole structure 301 of each connecting member 30 in the circumferential direction.

In this application, when the guide wire 40 controls the radial expansion of the tubular skeleton 10, the stent graft 100 can be released in multiple steps through the control of the guide wire 40, that is, the stent graft 100 is initially released in a tightened state. In the vascular cavity, the stent graft 100 is slightly expanded by adjusting the control guide wire 40, and the proximal structure of the stent is partially expanded, but the overall radial diameter of the stent is still smaller than the diameter of the blood vessel. When the position is inappropriate, by controlling the guide wire 40 to tighten the stent 100, it is still easier to adjust the position of the stent in the blood vessel. This process can be repeated many times until the stent 100 is released to the most suitable position to ensure that the stent 100 is released accurately Go to the position required by the patient to ensure the safety after the stent is released, and at the same time to better exert the therapeutic effect of the stent. After expansion, the stent graft 100 does not cover or occlude the key branch arteries, and the space in the expanded stent graft 100 It isolates the affected area well and provides a flow channel for blood to flow through. When the control guide wire 40 controls the contraction of the tubular skeleton 10, the stent graft 100 can be tightened multiple times by the control of the control guide wire 40, so that the tightened stent graft 100 can be transported by the conveyor 200. Smoothly enter the aortic lumen.

In a specific embodiment, in order to improve the stability of the contraction and expansion of the tubular framework 10, the number of connecting members 30 can be selected to be 4, and the 4 connecting members 30 surround the tubular framework 10 or the film 20 at equal intervals. Or the number of connecting pieces 30 can be set to 8, and the 8 connecting pieces 30 surround the tubular frame 10 or the film 20 at equal intervals. Regarding the specific number of the connecting members 30 and the specific positions of the connecting members 30, this application is not limited, as long as the guide wire 40 is controlled to pass through the through-hole structure 301 to control the contraction or expansion of the stent graft 100.

The connecting member 30 may be a flexible pull ring fixed on the covering film 20 or/and the tubular skeleton 10; or the connecting member 30 may be a piece of string fixed on the covering film 20 or/and the tubular skeleton 10 at a circumferential interval, and A gap for the control guide wire 40 to pass through is formed between the fixedly spaced cord and the covering film 20 or/and the tubular skeleton 10; or the connecting member 30 is a connecting ring provided on the covering film 20 with a through-hole structure 301 .

In a specific embodiment, the connecting member 30 is circumferentially arranged at least one circle around the stent graft 10. In other words, there are a plurality of connecting members 30, the plurality of connecting members 30 is at least one circle, and at least one circle of connecting members 30 circumferentially surrounds the stent graft 100. Specifically, the connecting member 30 may be a flexible connecting buckle with a limiting groove in at least one circle in the circumferential direction.

In a specific embodiment, the plurality of connecting members 30 has at least two turns, at least two turns of connecting members 30 circumferentially surround the stent graft 100, and there is a gap between the connecting members 30 of two adjacent turns. Specifically, the connecting member 30 may be at least two rounds of flexible connecting buckles with limiting grooves in the circumferential direction, and the openings of the limiting grooves in different rows are arranged facing away. The gap between the two adjacent loops of the connecting member 30 can make the control guide wire 40 of the two loops not interfere with each other when the control guide wire 40 passes through the connecting member 30, so that the control guide wire 40 can control the stent graft 20 in an orderly manner. Contraction and expansion. In other implementations, the plurality of connecting members 30 may also be half-circle, 3/4-circle or other forms in the circumferential direction.

In a specific embodiment, the connecting member 30 and the tubular stent or/and the covering film 20 are an integral structure. The connecting member 30 in this manner is an integrated structure extending from the covering film 20 or/and the tubular skeleton 10, and the connecting member 30 does not need to be manufactured separately, which saves time and labor costs.

In a specific embodiment, the connecting member 30 is a connecting ring. The connecting loop is a closed loop structure. The inner annular space of the closed loop structure can be the connecting member 30 with a through hole structure 301 through which the control guide wire 40 passes, or the connecting member 30 and the covering film 20 cooperate to form a through hole structure 301 through which the control guide wire 40 passes. Or gap. The connecting member 30 of the closed-loop structure makes the control guide wire 40 difficult to detach from the connecting member 30, the force controlled by the control guide wire 40 on the stent graft 100 is more stable, and the contraction and expansion of the stent graft 100 is more stable.

Alternatively, the connecting ring has an open ring structure. The open-loop structure may be that the connecting member 30 has a limiting groove with an opening on one side for the control guide wire 40 to pass through. The connecting member 30 with an open loop structure makes it easier to detach the control guide wire 40 from the connecting member 30.

In a specific embodiment, the connecting member 30 can be made of biocompatible materials, such as high molecular polymer materials such as PET and PTFE, or metal materials such as nickel-titanium alloy wires. The membrane 20 and/or the tubular skeleton 10 are fixedly connected.

In this application, as long as the stent graft 100 is provided with a through-hole structure 301, and the control guide wire 40 passes through the through-hole structure 301 to control the shrinkage or expansion of the stent graft 100, the specific position of the through-hole structure 301 is not limited. The material of the connecting member 30, the shape of the connecting ring, and the forming method of the connecting member 30 are not limited by this application.

4, the tubular frame 10 includes a plurality of annular support frames 110 spaced apart in the axial direction, the annular support frame 110 is formed by the metal rods 105 connected end to end formed by the equal height wave shape or high and low wave shape of the ring support frame 110. The ring support frame 110 includes the first layer ring support frame 101.

In this application, the metal rod 105 includes a first metal rod 101a and a second metal rod 101b. As shown in FIG. 2, the first metal rod 101a and the second metal rod 101b are connected at an angle, and the first metal rod 101a and the second metal rod 101a are connected at an angle. The two metal rods 101b are smoothly connected. The first metal rod 101a and the first metal rod 101a are relatively close to shrink the tubular frame 10, and the first metal rod 101a and the second metal rod 101b are relatively opened to expand the tubular frame 10. The plurality of annular support frames 110 extend with equal diameters or non-equal diameters. The metal rod 105 is made of an elastic metal material.

In a specific embodiment, when the connecting member 30 is a separate structure, the plurality of connecting members 30 are fixed on the first metal rod 101a or the second metal rod 101b of the first-layer annular support frame 101. The multiple connecting members 30 may be all fixed on the first metal rod 101a of the first-layer annular support frame 101, or all fixed on the second metal rod 101b of the first-layer annular support frame 101, or partly fixed on the first-layer annular support frame The first metal rod 101a of 101 is partially fixed to the second metal rod 101b of the ring support frame 101 of the first layer. As shown in FIGS. 2 to 3, there are eight connecting pieces 30, and the eight connecting pieces 30 are all fixed on the first metal rod 101a of the first-layer annular support frame.

Optionally, the connecting member 30 is fixed at 1/4-3/4 of the first metal rod 101a of the first-layer annular support frame 101 or the second metal rod 101b of the first-layer annular support frame 101. Preferably, the connecting member 30 is fixed at 1/2 of the first metal rod 101a or the second metal rod 101b of the first-layer annular support frame 101. When the connecting piece 30 is fixed at 1/2 of the first metal rod 101a or the second metal rod 101b of the first-layer annular support frame 101, the control guide wire 40 controls the first-layer annular support frame 101 to tighten or expand through the connecting piece 30 At this time, the force of the first-layer annular support frame 101 will be more uniform, the contraction and expansion of the first-layer annular support frame 101 will be more stable, and the contraction and expansion of the tubular frame 10 will be more stable.

In other implementations, the connecting member 30 may be at least one circle provided in the proximal end, the middle part and the distal end of the covering membrane 20. Alternatively, the connecting member 30 can also be fixed in at least one circle of the middle, the distal end, or the proximal end of the tubular skeleton 10. Of course, the connecting member 30 can also be arranged at other positions of the covering film 20 and/or the tubular skeleton 10.

In the present application, the annular support frame 101 includes a wave crest 101c, a wave trough 101d, and a wave rod 101e. Specifically, a first metal rod 101a and two second metal rods 101b are smoothly connected to form a wave trough 101d, a wave crest 101c, and a wave rod 101e, and the wave rod 101e is located between the wave trough 101d and the wave crest 101c. The height of the wave peak 101c is equal or unequal, and the height of the wave trough 101d is equal or unequal.

The first-layer annular support frame 101 is located at the beginning section of the proximal end of the tubular skeleton 10, and is a cut-type bare stent, with 1/2 part sutured in the covering film 20.

In other words, part of the first metal rod 101a and part of the second metal rod 101b of the first-layer annular support frame 101 at the proximal end of the tubular skeleton 10 are exposed outside the covering film 20. When part of the first metal rod 101a and the second metal rod 101b of the first-layer annular support frame 101 are exposed outside the membrane 20, and the tubular skeleton 10 is released, the barbs 90 on the wave trough 101d will be inserted into the aortic wall, and then The trough 101d of the first-layer annular support frame 101 can be stably connected to the aortic wall, and the stent graft 100 is firmly fixed on the aortic wall, which improves the stability of the connection between the stent graft 100 and the aortic wall. In a specific embodiment, 1/3-1/2 of the first metal rod 101a and the second metal rod 101b are covered in the covering film 20.

Please refer to FIG. 4, the diameter of the first-layer annular support frame 101 at the proximal end of the tubular frame 10 is larger than the diameter of the remaining annular support frames 110. Specifically, the inner space of the first-layer annular support frame 101 is the entrance for blood flow. The larger diameter of the first-layer annular support frame 101 increases its radial support force on the tube wall, so that the stent is fixed and stable and reduces the interference of blood flow. This makes the blood flow in the lumen of the stent graft smoother.

The hardness of the first annular support frame 101 at the proximal end of the tubular skeleton 10 is greater than the hardness of the other annular support frames 110. Specifically, the first-layer annular support frame 101 is a cutting-type stent, which has greater width and friction than a braided stent, and the remaining annular support frames 110 are used to adhere to the aortic wall and have a greater hardness of the first-layer annular support The frame 101 is beneficial for stabilizing on the arterial wall, while the remaining ring-shaped support frame 110 with less rigidity can reduce damage to the aortic wall.

Please continue to refer to FIG. 2, the ring support frame 101 on the first floor is provided with barbs 90, which are arranged along the axial direction of the ring support frame 101 on the first floor; between the barbs 90 and the ring support frame 101 on the first floor The included angle is α, 0°＜α＜90°. The barbs 90 pierce the covering film 20 and are exposed outside the covering film 20.

Specifically, the barb 90 is used to be inserted into the aortic wall to improve the stability of the connection between the stent graft 100 and the aortic wall. When the barb 90 extends out of the graft 20, the barb 90 can be directly inserted into the aortic wall Inside, it is fixed directly with the wall of the aorta. Therefore, in the present application, the barbs 90 fixed on the trough 101d inside the membrane 20 through the first-layer annular support frame 101 are inserted into the aortic wall to be directly inserted and fixed with the aortic wall. Compared with general stents, it reduces The contact area between the metal and the human body reduces the damage of the metal to the human body. At the same time, the included angle between the barb 90 and the annular support frame 101 is less than 90°, which can improve the radial support force of the barb area.

Since the first-layer annular support frame 101 at the proximal end of the tubular skeleton 10 is harder, the multiple barbs 90 are fixedly connected to the first-layer annular support frame 101 with greater hardness to improve the connection stability of the barbs 90, thereby increasing the barbs 90 insertion into the aortic wall for stability. At the same time, the stability of the connection of the stent graft 100 is improved. At the same time, the barb 90 is set at the valley 101d to leave enough space above the barb 90 to connect with other stent graft systems, thereby increasing adhesion and sealing.

The annular support frame 110 also includes a second-layer annular support frame 103, and the positions of the wave crests and wave troughs of the second-layer annular support frame 103 are arranged in one-to-one axial correspondence with the positions of the wave crests 101c and wave valleys 101d of the first-layer annular support frame 101, respectively. , The first layer of the ring support frame 101 partly stitched into the film 20, the part sewn into the film accounts for 1/2 to 2/3 of the first layer of the ring support frame 101, the wave trough 101d of the first layer ring support frame 101 is close to the film 20 The axial distance of the starting section of the end is between 5-10mm, and the axial distance between the trough of the second-layer annular support frame and the trough of the first-layer annular support frame is smaller than the wave height of the second-layer annular support frame, at 1 ～9mm. The second-layer annular support frame 103 is all stitched into the covering film 20, and the wave crests and troughs are embedded in the distal ends of the wave crest 101c and the wave valley 101d of the first-layer annular support frame 101, as shown in FIG. 4. The wire diameter of the second layer of annular support frame is 0.15~0.3mm, which is smaller than the wire diameter of other annular support frames 110, which is convenient for compression assembly in the sheath. Specifically, the wire diameter of the second layer of annular support frame is higher than that of other annular support frames. The wire diameter is 10 to 70% smaller, and more preferably, the wire diameter of the second-layer ring support frame is 20 to 50% smaller than the wire diameter of other ring support frames. In the present application, the second layer of annular support frame 103 is used to adhere to the aortic wall, and the second layer of annular support frame 103 with a smaller wire diameter and better flexibility is close to the distal end of the first layer of annular support frame 101, which is beneficial to The area near the supporting barbs 90 stably adheres to the arterial wall, improves the adhesion of the proximal end of the stent graft 100 to enhance the overall sealing of the stent graft 100, and prevents blood from flowing away from the gap between the stent and the blood vessel wall.

The ring support frame 110 also includes a plurality of high and low wave ring support frames that are semi-sutured outside the covering film 20 and arranged axially at the distal end of the second layer of the ring support frame 103, which improves the radial support force and bending flexibility of the main stent .

Referring to FIG. 4, the tubular skeleton 10 further includes a plurality of branched annular stents 102, the plurality of branched annular stents 102 are located on one side of the main body annular stent 101, and the plurality of branched annular stents 102 are arranged side by side. In this embodiment, there are two branch ring stents 102, the two branch ring stents 102 and the main ring stent 101 are integrally formed, the distal end of the stent graft 100 extends out of two branch stents, and the long branch proximal ring stent adopts a smaller The wire diameter improves the flexibility. The distal ring stent adopts a larger wire diameter to increase the radial support force to ensure that the distal end adheres to the wall and prevent type I internal leakage. The most important thing in abdominal aortic stent transplantation is the accurate anchoring position of the stent graft 100 during implantation, so that the stent graft 100 can seal the aortic wall and stabilize it on the aorta. It is critical that the stent graft 100 does not cover or occlude after expansion. The space in the expanded stent graft 100 provides a flow channel for blood to flow through the aneurysm.

Please continue to refer to Figures 1-2, the conveyor 200 includes a control guide wire 40 and a conveyor tip 50. The control guide wire 40 passes through the connector 30 to control the radial contraction or expansion of the tubular skeleton 10; the conveyor tip 50 It includes a fixing part 60 facing the direction of the operating handle, at least one channel 601 is provided on the fixing part 60, and the fixing part 60 is located at the proximal end of the connecting member 30.

Referring to FIG. 5, in a specific embodiment, two channels 601 are provided on the fixing portion 60, and the two ends of the control guide wire 40 respectively pass through the two channels 601. After the stent graft 100 is released, the control guide wire 40 is withdrawn from the channel 601 and finally withdrawn from the body. In this application, the channel 601 is an open structure or a closed structure. After the two ends of the control guide wire 40 pass through the channel 601, the stent graft 100 is tightened and released by controlling the axial movement of the two ends of the guide wire 40.

Optionally, the fixing part 60 of the conveyor tip 50 is located on the central axis of the stent graft 100, the two channels 601 are also symmetrically arranged on both sides of the central axis, and the two ends of the control guide wire 40 pass through the two channels 601. Later, the stent graft 100 can be controlled to be folded from the outside to the center, or the stent graft 100 can be controlled to be released from the center to the outside.

Please refer to FIGS. 6-7. In another specific embodiment, the fixing portion 60 includes a fixing wire groove 603 and a channel 601, the fixing wire groove 603 and the control guide wire 40 are detachably connected, and the fixing wire groove 603 is provided There is a fixed wire 80, one end of the control guide wire 40 is sleeved on the fixed wire 80, and the other end of the control guide wire 40 passes through the channel 601. By withdrawing the fixed wire 80, the control guide wire 40 is separated from the fixed wire groove 603 and finally withdrawn in vitro. In this manner, the fixing wire 80 is made of a rigid material for detachably connecting and fixing the distal end of the control guide wire 40. The distal end of the control guide wire 40 can be bent to form a guide wire ring 401, and the fixing wire 80 passes through the guide wire.丝环401。 Silk ring 401. After the stent graft 100 is released, the fixed wire 80 is first withdrawn to release the ring guide wire at the distal end of the control guide wire 40 from the fixation, and then the proximal end of the control guide wire 40 is pulled backwards, and the control guide wire 40 is completely withdrawn. In this way, the stroke of withdrawing the control guide wire 40 is halved, the distal end of the guide control guide wire 40 and the stent are more efficiently released, and the operation risk is reduced. The control guide wire 40 in this manner is preferably a single-strand flexible rope, a ring structure is left at the distal end as a guide wire loop at the proximal end of the control guide wire 40, and one end (proximal end) of the control guide wire 40 passes through the conveyor tip 50 The channel 601 and the inner cavity of the conveyor 200 reach the handle control member, the ring-mounted structure at the other end (distal) of the control guide wire 40 is sleeved on the control fixing wire 80, the fixing wire 80 passes through the fixing wire groove 603, and the control guide The proximal end of the wire 40 is fixed on the handle control assembly of the conveyor 200.

Please continue to refer to Figures 2 to 3, the conveyor 200 also includes a guide wire tube 70 connected to the fixing part 60 of the end of the conveyor. The guide wire tube 70 penetrates the inner space of the stent graft 100 to control both ends of the guide wire 40 After passing through the two channels 601 respectively, they are housed in the guide wire tube 70. In this embodiment, the guide wire tube 70 is provided with two through slots 701, and one through slot 701 is used to receive one end of the control guide wire 40 to pass through.

The handle assembly is connected to the distal end of the guide wire tube 70. After the two ends of the control guide wire 40 pass through the guide wire tube 70, they are fixed on the handle assembly, and the control guide wire 40 is pulled by the handle assembly.

When the proximal end of the stent graft 100 is released, moving the rear handle assembly of the conveyor 200 can relax the control guide wire 40, expand the proximal end of the stent graft 100, and control the movement of the handle assembly to control the first body ring shape at the proximal end of the skeleton The expansion amount of the stent 101, when the stent graft 100 is completely released, the stent graft 100 adheres to the blood vessel; when the stent graft 100 is not completely adhered to the blood vessel, the proximal end of the skeleton can be tightened by controlling the guide wire 40 The main body ring stent 101, the stent graft 100 is tightened, and the transporter 200 is moved to perform stent positioning again, and re-attach to the blood vessel until the stent graft 100 is completely attached to the blood vessel.

The above-disclosed are only the preferred embodiments of the present invention. Of course, the scope of rights of the present invention cannot be limited by this. Those of ordinary skill in the art can understand all or part of the procedures for implementing the above-mentioned embodiments and make them in accordance with the claims of the present invention. The equivalent changes of is still within the scope of the invention.

Claims

A stent graft, which is characterized by comprising: a tubular skeleton, a membrane fixed on the tubular skeleton, and a connector, the connector being arranged on the tubular skeleton or the membrane, the The connecting piece is passed through by the control guide wire to control the radial contraction or expansion of the tubular skeleton.
The stent graft according to claim 1, wherein the connecting member is fixedly connected to the graft film and/or the tubular skeleton by stitching, heat sealing or welding.
The stent graft according to claim 1, wherein the connecting member is the tubular skeleton or/and the through-hole structure on the graft.
The stent graft according to claim 1, wherein the connecting member is arranged at least one circle around the stent graft.
The stent graft according to claim 1, wherein the tubular frame comprises a plurality of annular support frames arranged at intervals along the axial direction, and the annular support frame is a wavy ring formed by metal rods connected end to end. Shaped support frame, said ring-shaped support frame includes wave crests, wave troughs and poles; said ring-shaped support frame includes a first-layer ring-shaped support frame, at least one of said first-layer ring-shaped support frame is provided with barbs, and said inverted The included angle α between the thorn and the wave trough is 0°<α<90°.
The stent graft according to claim 5, wherein the first-layer annular support frame is located at the beginning section of the proximal end of the tubular skeleton, partially sutured on the inner surface of the graft, and the barbs pass through the The covering film is exposed outside the covering film.
The stent graft according to claim 5, wherein the ring-shaped support frame further comprises a second-layer ring-shaped support frame, and the positions of the wave crests and the wave troughs of the second-layer ring-shaped support frame are respectively the same as those of the first-layer ring-shaped support frame. The wave crests and wave troughs of the frame are arranged in one-to-one axial correspondence, and the axial distance between the wave troughs of the first-layer annular support frame and the starting section of the proximal end of the film is not more than 10 mm.
The stent graft according to claim 7, wherein the axial distance between the wave trough of the second-layer annular support frame and the wave trough of the first-layer annular support frame is smaller than the wave height of the second-layer annular support frame.
The stent graft according to claim 7, wherein the wire diameter of the second-layer annular support frame is 10 to 70% smaller than that of other annular support frames.
A stent graft system, characterized by comprising the stent graft according to any one of claims 1-9, the stent graft system further comprising a conveyor, the conveyor comprising a control guide wire and a conveyor The tip, the control guide wire passes through the connecting piece to control the radial contraction or expansion of the tubular skeleton; the proximal end of the conveyor tip includes a fixing part, and the fixing part is provided with at least one channel, and The fixing portion is located on the side of the plane formed by the connecting piece facing the end of the conveyor or on the plane formed by the connecting piece.
The stent graft system of claim 10, wherein the control guide wire is detachably connected to the channel.
The stent graft system according to claim 11, wherein the fixing part is provided with two channels, two ends of the control guide wire respectively pass through the two channels, and the control guide The wire is used to withdraw from the channel after the stent graft is released.
The stent graft system according to claim 11, wherein the fixing part comprises a fixing wire groove and a channel, and a fixing wire is provided in the fixing wire groove. When one end of the fixing wire is connected to the When the walls of the fixed wire groove abut, one end of the control guide wire is fixed by the fixed wire, the other end of the control guide wire passes through the channel, and the control guide wire and the fixed wire are used to After the release of the stent graft, the stent graft is removed from the fixing wire groove.