WO2020034787A1

WO2020034787A1 - Stent graft

Info

Publication number: WO2020034787A1
Application number: PCT/CN2019/095333
Authority: WO
Inventors: 肖本好; 黄新鑫
Original assignee: 先健科技(深圳)有限公司
Priority date: 2018-08-17
Filing date: 2019-07-10
Publication date: 2020-02-20
Also published as: CN110833469B; CN110833469A

Abstract

The present invention provides a stent graft, comprising a tubular membrane and at least one first stent unit connected to an end portion of the membrane. The first stent unit comprises a first wave loop and a second wave loop. The first wave loop and the second wave loop overlap to form a plurality of intersection points. The first wave loop and the second wave loop both comprise a plurality of crests and troughs. At least one of the adjacent crests and troughs is provided with at least one suture knot, and the intersection points are provided with at least one suture knot. The first stent unit of the stent graft of the present invention is tightly sutured together with the membrane, thereby greatly enhancing the adherence of the stent and the tightness of the stent graft, and thus solving the problem of membrane curling occurring in the stent graft, ensuring the safety in use after stent implantation, and avoiding type I endoleaks.

Description

Stent graft

Technical field

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

Background technique

Aortic aneurysm and aortic dissection are extremely dangerous diseases, which are mainly divided into aortic dissection, aortic true aneurysm, and aortic pseudoaneurysm. The mortality of aortic disease is greater than 50% at 48 hours and greater than 5% at 2 weeks after the onset of aortic disease. It has seriously threatened human health. With the aging trend in China, the incidence of aortic aneurysms and aortic dissections will continue to rise.

For the aortic disease, the current main treatment is vascular graft. Therefore, a large number of artificial vascular stents are needed clinically as vascular substitutes. At present, the use of polyester (PET), polytetrafluoroethylene (PTFE), natural silk and other artificial materials to prepare stents has been used in clinical practice, and has achieved satisfactory results. Among them, polyester cloth (PET) or artificial blood vessel is used as the covering material. When combined with metal stent, the metal stent is usually sutured with polyester cloth / artificial blood vessel to form a blood vessel covered stent.

Due to the poor suture method of the existing vascular stent graft, the stent graft often has the phenomenon of flaring of the membrane, displacement of the metal stent, poor stent adherence or poor sealing. As shown in FIG. 1 and FIG. 2, the end of the pellicle 01 is turned outward toward the stent, the metal stent 02 sutured on the pellicle is displaced, and even part of the stent protrudes from the end of the pellicle or is lifted. After the stent is implanted, if the metal stent is shifted or tilted, not only the stent shape and treatment effect are not good, but also type I endoleaks are likely to occur. Secondary intervention is required to ensure the effect of the surgery. Time has increased the difficulty of surgery and the risk of trauma to the patient. In addition, the displacement of the metal stent and the lifting of the metal stent can easily cause damage to the patient's autologous blood vessels.

Based on this, it is necessary to provide a stent graft with good adherence, which solves the problem of tumbling of the stent, so that the stent is less likely to cause type I endoleak after being implanted in the human body.

Summary of the Invention

The present invention provides a stent graft, which includes a tubular stent and at least one first stent unit connected to an end of the stent, the first stent unit includes a first wave coil and a second wave coil. The first wave circle and the second wave circle overlap to form a plurality of intersection points; the first wave circle and the second wave circle each include a plurality of wave peaks and a plurality of wave valleys, and at least one of the adjacent wave peaks and wave valleys is provided There is at least one suture knot, and at least one suture knot is provided at the intersection.

In one embodiment, at least two suture knots are provided at the intersection.

In one embodiment, the crests of the first wave circle are opposite to the troughs of the second wave circle, and at least one suture knot is provided at each of the crest and the trough.

In one embodiment, the first stent unit is disposed inside or outside the cover film.

In one embodiment, a plurality of suture knots at the peaks and / or troughs are connected by a suture.

In one embodiment, the suture knots at the crests and / or troughs are connected to the at least one suture knot at the intersections by sutures.

In one embodiment, at least one of the suture knots is not connected to other suture knots.

In one embodiment, the suture knots do not overlap.

In one embodiment, the first end of the pellicle is provided with a plurality of first stent units; among two adjacent first stent units, the peak of one of the first stent units and the peak of the other first stent unit The valleys are connected.

In one embodiment, the farthest first stent unit of the plurality of first stent units is connected to the cover film by a suture.

In one embodiment, the first stent unit is provided at both the proximal end and the distal end of the pellicle.

The stent graft provided by the present invention is provided with a plurality of suture knots on the first stent unit located at the end of the stent, specifically, at least one suture knot is arranged at the crest and trough of the wave circle, and at least two are arranged at the intersection of the wave circle. Suture knots, so that the loop and the suturing are more closely stitched, the morphological structure between the loop and the stent is maintained, the adherence of the stent is enhanced, and the problem of stent flanging is solved. Ⅰ-type internal leakage is generated to ensure the safe use of the stent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a film-covered cuff occurring in a conventional film-covered stent; FIG.

FIG. 2 is a schematic diagram of metal stent displacement in the prior art stent graft;

3 is a schematic structural diagram of a stent graft according to a first embodiment of the present invention, including a first stent unit;

4 is a schematic structural diagram of a portion of a first bracket unit in FIG. 3;

FIG. 5a is a schematic diagram of a suture manner of a first stent unit and a cover film in Embodiment 1; FIG.

5b to 5e are schematic diagrams of a suture manner of a first stent unit and a covering film according to another embodiment of the present invention;

FIG. 6a to FIG. 6c are schematic diagrams of the steps of specific needle insertion and knotting in the suture method of FIG. 5;

7 is a schematic structural diagram of a stent graft according to a second embodiment of the present invention, including a plurality of first stent units;

FIG. 8 is a schematic diagram of a plurality of first bracket units in FIG. 7 in an expanded structure; FIG.

FIG. 9 is a schematic diagram of a stent graft implanted into the thoracic aorta according to the second embodiment of the present invention.

detailed description

In order to better understand the present invention, specific embodiments of the technical solution of the present invention are described in detail below with reference to the accompanying drawings. In the field of implantable medical devices, the end near the heart is defined as "proximal" and the end far from the heart is defined as "distal". "Proximal" and "distal" are collectively referred to as "ends".

The stent graft of the present invention can be used for a thoracic aorta stent graft or an abdominal aorta stent graft. Of course, those skilled in the art can also use other stent according to actual needs. In the following specific embodiments, a thoracic aorta stent graft will be used as an example for illustration.

Example one

As shown in FIG. 3, the stent graft 10 of this embodiment is a hollow elongated columnar structure with openings at both ends, and includes a tubular stent 11, a plurality of main body stent units 12 spaced apart along the length direction of the stent 11, and Two first stent units 13 at the proximal end and the distal end of the pellicle 11. Wherein, the main body stent units 12 are all disposed outside the cover film 11, and the first stent units 13 are all disposed inside the cover film 11. Both the main body stent unit 12 and the first stent unit 13 are connected to the cover film 11 by a suture. The suture may be made of a biocompatible material, and may be a PET suture or a PTFE suture. The covering film 11 may be a vascular prosthesis, a tubular polyester cloth, or other conventional covering materials used for manufacturing a covered stent.

The main body stent unit 12 has a substantially repeated W shape and is made of a material having a certain elasticity and supporting strength. The main body stent unit 12 is used to support the stent 11 and keep the stent 10 in a certain shape after being implanted in a human body, so that it is not easy to collapse.

As shown in FIG. 4, the first bracket unit 13 has a double wave coil structure, that is, the first bracket unit 13 includes a first wave coil 131 and a second wave coil 132 interwoven with each other. The first wave circle 131 and the second wave circle 132 intersect to form a plurality of intersection points 135, and each of the first wave circle 131 and the second wave circle 132 has a plurality of links 136. The plurality of links 136 are connected end to end to form a plurality of wave peaks 133 and a plurality of wave valleys 134. The wave peak 133 of the first wave circle 131 is opposite to the wave valley 134 of the second wave circle 132. It can be understood that, in other embodiments, the peaks of the first wave circle and the troughs of the second wave circle may also be set out of position. The first wave loop 131 and the second wave loop 132 in this embodiment are woven from the same braided wire. It can be understood that, in other embodiments, the first wave loop and the second wave loop may also be woven by separate braided wires.

Referring to FIG. 5a at the same time, the first bracket unit 13 of this embodiment is connected to the cover film 11 by a suture 137 (including 137a and 137b). By providing a plurality of suture knots 138 (including 138a, 138b, 138c, and 138d) on the suture 137, the first stent unit 13 and the cover film 11 can be closely stitched together. Specifically, one suture knot 138a and 138b is provided at each of the crest 133 and the trough 134, and two

suture knots

138c and 138d are provided at the intersection 135. The

suture knots

138c and 138d do not overlap, and 138c is closer to the

peak

133 and 138d is closer to the trough 134. Among them, the suture knot 138a at the peak 133 and one of the suture knots 138c at the intersection 135 are on the same suture 137a; the suture knot 138b at the valley 134 and one suture knot 138d at the intersection 135 are on the same suture 137b.

It can be understood that, in other embodiments, other continuous sutures can also be used for suture. For example, the suture can be sutured along a single wave circle, that is, the suture 137c is used to sew in the order of crest-intersection-wave trough-intersection. After completing the stitching of the first wave circle, the stitching of the second wave circle is completed in the same order, and then the knotting is completed. The structure is shown in FIG. 5b. This suture method uses one suture to complete the suture, and there is no need to restart the needle in the middle, which can reduce the risk of loose sutures caused by too many knots. Alternatively, when stitching the first loop, the stitches 137e are stitched in the order of crest-intersection-intersection-trough-intersection, that is, the intersection is tightly wound with sutures and two suture knots are set, and the second loop is stitched. The line 137f is stitched in the order of crest-valley-wave crest, and the structure is shown in FIG. 5c. This stitching method can fasten the first wave loop and the second wave loop of the double wave loop by sutures to ensure that the position of the intersection point after the double wave stitch is not shifted. Alternatively, use four different sutures (137g, 137h, 137i, 137j), first use the 137g suture to complete the peak-to-peak suture, then use the sutures 137h and 137i to complete the two sutures at the intersection-intersection, and finally use The suture 137j completes the trough-trough suture, and the structure is shown in Fig. 5d. The double-layered coil 13 of the first unit of the stent is sewn along the circumferential direction according to the crests, intersections, and valleys of the sub-regions to ensure the circumferential stability of the wave circle while preventing the suture points in some regions from being loose and spreading to other suture regions. Or alternatively, each suture knot 138e is an independent structure, that is, one suture knot 138e is completed, that is, the suture is cut, and then the suture knot is stitched at the next position. The structure is shown in FIG. 5e, which can reduce the use of sutures. , The compression diameter of the bracket is smaller during assembly. Or the above-mentioned continuous suture method is alternately arranged with independent suture knots.

The first stent unit 13 of this embodiment is sutured on the pellicle 11 by continuous suture. The specific process of suturing the first stent unit 13 on the pellicle 11 by using a suture 137 can be seen in FIGS. 6a to 6c. The first stent unit 13 in this embodiment is sutured on the inside of the pellicle, but for the convenience of description and viewing, FIGS. 6a to 6c show the perspectives of the stent suture on the outside of the pellicle. The specific suture steps are described below. First, the needle 14 starts from the inside of the cover 11 and passes from the inside of the cover to the outside of the cover next to the first stent unit 13; here is the first puncture point; The other position on the same side of a stent unit 13 serves as a second puncture point. It passes from the outside of the stent 11 to the inside of the stent 11 and then passes under the first stent unit 13 and then approaches the first stent. The position on the other side of the unit 13 and opposite to the second puncture point passes from the inside of the pellicle 11 to the outside of the pellicle 11; then, the needle 14 with the suture 137 is passed over the first stent unit 13 and Pass under the suture 137 between the first puncture point and the second puncture point; finally tighten the suture 137 to complete a suture knot. Follow the above steps to sew and tie knots at crests 133, troughs 134, and intersections 135 until you return to the stitching point, kill the knots, and burn off the extra sutures 137 to complete the stitching. Referring to FIG. 5a again, the first stent unit 13 of this embodiment is sutured by two sutures 137. When sutures are first used, the plurality of wave crests 133 and 135 of the first wave circle 131 and the second wave circle 132 are sutured by using the suture 137a. On the cover film 11, a plurality of troughs 134 and intersections 135 are stitched on the cover film 11 by using the suture 137 b in the same method. Separating the crest and trough separately can ensure the stability between the first stent unit and the mulch. For example, when the crest is stressed alone, the trough will not be affected, and vice versa. It can be understood that the needle can be started from the inside of the film, or it can be started from the outside of the film. Similarly, the suture knot can be tied on the side of the stent where the first stent unit is located, or on the opposite side of the stent where the first stent unit is located, that is, whether the first stent unit is located inside or outside the stent, the suture is sutured. The knots can be hit on the inside of the membrane, or on the outside of the membrane, as long as the suture is convenient. When the suture knot hits the inside of the stent, the stent at the proximal end of the stent is easier to be compressed on the blood vessel by the double-layer wave ring of the first unit of the expandable stent, and the stent has good adherence and sealing performance; When the knot is on the outside of the stent, it can increase the friction between the stent and the blood vessel, and increase the anti-displacement performance of the stent.

It can be understood that, in other embodiments, multiple suture knots may be provided at the peak and trough positions, and more than two suture knots may be provided at the intersection point, as long as the suture knots do not overlap. Overlap will increase the delivery size of the stent graft, and a larger diameter delivery sheath is required to complete the delivery. Furthermore, a suture knot or a suture point can also be provided on the connecting rod. The suture point refers to that the suture passes through the membrane from this point and continues to be sutured forward. At this point, no suture knot is performed.

It can also be understood that, in other embodiments, only one suture knot may be provided in adjacent peaks and troughs, and only one suture knot may be provided at the intersection. This can reduce the number of suture knots, thereby reducing the diameter of the stent after compression, and the use of a sheath tube with a smaller diameter can complete the loading and delivery of the stent.

It can also be understood that, in other embodiments, the stent graft can also be provided with the first stent unit only at the proximal end or the distal end, that is, by setting the first stent unit at any end of the stent according to the method of the present invention, Effects of the present invention.

In addition, in other embodiments, the main body stent unit and the first stent unit may all be arranged inside or outside the pellicle, or partly inside the pellicle, and partly outside the pellicle. Those skilled in the art may according to actual requirements Make adjustments accordingly.

The stent graft of this embodiment is provided with a first stent unit at the proximal end, and a suture knot is provided at both the peak and trough of the first stent unit when sutured, and is provided at the intersection of the first wave circle and the second wave circle. The two suture knots make the first stent unit and the stent tightly sutured, which greatly enhances the adherence of the stent and the tightness of the stent itself, thereby solving the problem of tumbling of the stent and ensuring the stent grafting. After use, it is safe to use without type I endoleak.

Example two

As shown in FIG. 7, the structure of the stent graft 20 of this embodiment is substantially the same as the structure of the stent graft 10 of the first embodiment, except that the proximal end of the stent graft 20 of this embodiment is provided with a plurality of first One bracket unit 23. As shown in FIG. 8, the peak of the farthest first bracket unit 23a is connected to the valley of the adjacent first bracket unit 23b, and the peak of the first bracket unit 23b is then connected to another first bracket unit adjacent thereto. The valleys are connected, and multiple first bracket units are combined together in such a manner that the peaks and valleys are connected to each other. The number of the first stent unit sutured with the stent 21 is preferably not more than three. Too many will cause insufficient support at the proximal end of the stent 20. The stent 20 of this embodiment has only the most distal first stent unit. 23a is sewn to the cover film 21. Referring to FIG. 9 at the same time, after the stent graft 20 of this embodiment is implanted into the human thoracic aorta, the first stent unit that is not sutured with the stent 21 directly contacts the wall of the thoracic aorta, increasing the stent graft 20 End of the anchoring area. Therefore, after the stent graft 20 is implanted into the human body, it will not be displaced under the impact of blood flow because the anchoring area is too narrow.

Compared with the first embodiment, a plurality of first stent units 23 are provided at the proximal end of the stent graft 20 in this embodiment, so that the proximal anchoring area of the stent is larger and the flexibility is better, and the blood flow impact resistance is stronger, and Providing multiple first stent units can adapt the stent graft to more types of aortic aneurysms and aortic dissections.

The above specific embodiments merely explain the technical solutions of the present invention, make the present invention easy to understand, and do not limit the present invention. The above-mentioned embodiments are merely examples of implementation forms of the technical solutions of the present invention, and some technical features of the embodiments may be appropriately combined, and the present invention does not list them one by one. Those skilled in the art can simply replace and combine the parts according to the actual situation under the teaching of the present invention. The protection scope of the present invention is subject to the claims.

Claims

A stent graft includes a tubular stent and at least one first stent unit connected to an end of the stent, the first stent unit includes a first wave circle and a second wave circle, and the first wave circle And the second wave circle overlaps to form a plurality of intersection points; the first wave circle and the second wave circle each include a plurality of wave peaks and a plurality of wave valleys, wherein at least one of the adjacent wave peaks and wave valleys is provided There is at least one suture knot, and at least one suture knot is provided at the intersection.
The stent graft according to claim 1, wherein at least two suture knots are provided at the intersection.
The stent graft according to claim 2, wherein a peak of the first wave circle is opposite to a valley of the second wave circle, and at least one suture knot is provided at each of the wave peak and the wave valley.
The stent graft according to claim 1, wherein the first stent unit is disposed inside or outside the stent.
The stent graft according to claim 4, wherein a plurality of suture knots at the crests and / or troughs are connected by a suture.
The stent graft according to claim 5, wherein the suture knots at the crests and / or troughs are connected to at least one suture knot at the intersections by sutures.
The stent graft according to claim 4, wherein at least one of the suture knots is not connected to other suture knots.
The stent graft according to claim 1, wherein the suture knots do not overlap.
The stent graft according to claim 1, wherein a plurality of first stent units are provided at the proximal end of the stent; among the two adjacent first stent units, the peak of one of the first stent units It is connected to the trough of another first bracket unit.
The stent graft according to claim 9, wherein the most distal first stent unit of the plurality of first stent units and the stent graft are connected by a suture.
The stent graft according to any one of claims 1 to 9, characterized in that both the proximal end and the distal end of the stent are provided with the first stent unit.