CN114681113A

CN114681113A - Covered stent system

Info

Publication number: CN114681113A
Application number: CN202011598256.9A
Authority: CN
Inventors: 王韶霞; 舒畅; 朱清; 屠春霖; 陈伊璐
Original assignee: Shanghai Minimally Invasive Heart Pulse Medical Technology Group Co ltd
Current assignee: Shanghai Minimally Invasive Heart Pulse Medical Technology Group Co ltd
Priority date: 2020-12-29
Filing date: 2020-12-29
Publication date: 2022-07-01
Also published as: WO2022142800A1

Abstract

The invention relates to a covered stent system. The covered stent system comprises a covered stent and a beam diameter piece arranged on the covered stent; the beam diameter piece is used for restraining the covered stent and can release the covered stent; the inner diameter of the covered stent after being bound is smaller than that of the covered stent after being released, and the bound covered stent is provided with a through inner cavity. This covered stent system treats after the covered stent system guides into abdominal aortic aneurysm pathological change position because the footpath piece can tie the covered stent then, covered stent does not laminate with the blood vessel, covered stent can move between nearly, the distal end after tying through the footpath piece and until the first window of covered stent moves towards abdominal cavity trunk artery and/or mesentery arteria superior and second window orientation renal artery, still adjustable covered stent in the branch covered stent guide-in-process in order to establish the blood flow passageway, do benefit to accurate location, covered stent after the constraint has the inner chamber that link up, this inner chamber that link up can make the blood flow smoothly pass through, guarantee the blood flow of covered stent inner chamber and pour.

Description

Covered stent system

Technical Field

The invention relates to the technical field of medical appliances, in particular to a covered stent system.

Background

Abdominal Aortic Aneurysm (AAA) is a common Aortic disease in vascular surgery, and refers to a local pathological dilatation of the Abdominal aorta, exceeding 50% of the normal vessel diameter. Once the tumor body is cracked, the fatality rate can reach 78% -94%, and the life safety of the patient is seriously threatened. Because of the high difficulty and the large surgical trauma of the traditional surgical treatment, the endovascular prosthesis implemented by using the aorta abdominalis covered stent is widely used. The intraluminal repair is a repair technique for treating abdominal aortic aneurysm by delivering a covered stent to a diseased part to establish a new blood flow channel in a tumor cavity and further isolating the impact of high-pressure blood flow of abdominal aorta on the tumor wall.

In particular, for complicated abdominal aortic aneurysms involving visceral arteries, such as renal arteries and intercostal arteries, the treatment difficulty is high, a window needs to be formed in the stent graft, and a branch stent graft is mounted on the window to lead to the involved branch vessels. However, the increased implantation of the branch stent graft increases the difficulty of the surgical operation and increases the clinical risk.

Disclosure of Invention

In view of the above, there is a need to provide a stent graft system that addresses the problem of increased difficulty in surgical procedures due to implantation of a branched stent graft.

A stent graft system, comprising: the device comprises a covered stent and a beam diameter piece arranged on the covered stent;

the beam diameter piece is used for restraining the covered stent and can release the covered stent;

the inner diameter of the covered stent after being bound is smaller than the inner diameter of the covered stent after being released, and the covered stent has a through inner cavity after being bound.

In one embodiment, the ratio of the bound inner diameter to the released inner diameter of the covered stent is (1-4): 5.

in one embodiment, the beam diameter member comprises: a guide wire and a plurality of binding coils distributed at intervals along the length direction of the guide wire;

the binding coil is used for binding the covered stent, and the binding coil is detachably connected with the guide wire in a loose knot mode so as to release the covered stent when the guide wire is pulled.

In one embodiment, the material of the binding coil is at least one selected from PET, PTFE, ePTFE, and PP.

In one embodiment, the cinch coil is coupled to the guidewire in a slip knot fashion.

In one embodiment, the first end of the cinch coil rotates at least one turn around the stent graft and exits the second end of the cinch coil;

the guide wire is arranged at the first end of the restraining coil in a penetrating mode so as to fasten the restraining coil.

In one embodiment, the plurality of binder coils are formed by bending the same binder line.

In one embodiment, a plurality of fixed coils are further arranged on the covered stent, and the binding coils are circumferentially arranged in the corresponding fixed coils in a penetrating manner.

In one embodiment, the stationary coils include at least one stationary coil group disposed in an axial direction of the stent graft, each of the stationary coil groups being distributed around a circumference of the stent graft and a number of the stationary coils of each of the stationary coil groups being at least 3.

In one embodiment thereof, the stent graft comprises: the stent comprises a metal stent and a covering film covering the metal stent;

the suture between the metal stent and the cover film is pulled out to the outside of the cover film stent to form the fixed coil.

In one embodiment thereof, the metal bracket comprises: the support rings are arranged at intervals along the axial direction and are formed by connecting a plurality of support rods;

the fixed coil is located in the area where the length L proportion of the supporting rod is 1/3-2/3.

In one embodiment, the stent graft comprises, in order from proximal to distal: the stent graft comprises a near-end stent graft, a middle stent graft and a far-end stent graft, wherein the inner diameter of the middle stent graft is the smallest;

the junction of the near-end covered stent and the middle covered stent is provided with at least one first window, the junction of the middle covered stent and the far-end covered stent is provided with at least one second window, and the first window and the second window are both used for installing branch covered stents.

In one embodiment, a first embedded branch is disposed at the first window, a second embedded branch is disposed at the second window, and the first embedded branch and the second embedded branch are both located in the stent graft.

In one embodiment, the number of the first windows is two, the two first windows are circumferentially distributed on the same side of the stent graft, and the distance between every two adjacent first windows in the axial direction of the stent graft is 0-30 mm;

and/or the number of the second windows is two, the two second windows are circumferentially distributed on the opposite side of the covered stent, and the distance between the two adjacent second windows in the axial direction of the covered stent is 0-30 mm.

In one embodiment, a proximal edge of the proximal stent graft, and/or a distal edge of the distal stent graft, and/or the first window, and/or the second window is provided with a visualization portion.

In one embodiment, the developing part is fixed by sewing with a suture.

The covered stent system can be used for treating complex abdominal aortic aneurysm involving visceral artery, the covered stent can be bound by the diameter binding piece, after the covered stent system is guided into an abdominal aortic aneurysm lesion part, the covered stent is not attached to a blood vessel, the covered stent can be finely adjusted between a near end and a far end after being bound by the diameter binding piece until a first window of the covered stent faces towards an abdominal trunk artery and/or an superior mesenteric artery and a second window of the covered stent face towards a renal artery, meanwhile, the covered stent can be adjusted in the process of guiding the branch covered stent to establish a blood flow channel, accurate positioning is facilitated, the bound covered stent has a through inner cavity, blood can smoothly pass through the through inner cavity, blood perfusion of the inner cavity of the covered stent is guaranteed, and relevant complications caused by ischemia of an abdominal aortic main cavity are avoided.

Drawings

FIG. 1 is a schematic structural view of a stent graft according to an embodiment of the present invention after being constrained by a constraining member;

FIG. 2 is a schematic structural view of a proximal stent graft of the present invention after release of the stent graft restraining member;

FIG. 3 is a schematic structural view of a stent graft according to an embodiment of the present invention;

FIG. 4 is a schematic structural diagram of an abdominal aortic aneurysm involving the celiac trunk, superior mesenteric arteries, and renal arteries according to an embodiment of the present invention;

FIG. 5 is a schematic structural view of a stent graft with a first branch stent graft and a second branch stent graft mounted thereon according to an embodiment of the present invention;

FIG. 6 is a schematic view of the position relationship between the tethered coil and the stent graft before the tethered coil is wound around the stent graft according to one embodiment of the present invention;

FIG. 7 is a schematic structural view of a proximal stent graft according to an embodiment of the present invention after being constrained by a constraining member;

FIG. 8 is a schematic view of a tethered coil wound on a stent graft according to one embodiment of the present invention;

FIG. 9 is a schematic view illustrating a process of bending a plurality of binding loops by a binding line according to an embodiment of the present invention;

FIG. 10 is a schematic view of the position relationship between the tethered coil and the stent graft before the tethered coil is wound thereon according to another embodiment of the present invention;

FIG. 11 is a schematic structural view of a stent graft with a first branch stent graft and a second branch stent graft mounted thereon according to another embodiment of the present invention.

Wherein the reference numerals in the drawings are as follows:

100. a covered stent; 110. a metal bracket; 111. a support ring; 120. coating a film; 100a, a proximal stent graft; 100b, a middle covered stent; 100c, a distal stent graft; 130. a bare metal stent; 140. a first embedded branch; 150. a second embedded branch; 160. a developing section; 170. fixing the coil; 200. a beam diameter member; 210. a guide wire; 220. binding the coil; 300. a first branch stent graft; 400. a second branch stent graft; A. abdominal aortic aneurysm; a1, abdominal trunk; a2, superior mesenteric artery; a3, renal artery; m, binding lines.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, as those skilled in the art will recognize without departing from the spirit and scope of the present invention.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to implicitly indicate the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be interconnected within two elements or in a relationship where two elements interact with each other unless otherwise specifically limited. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "above," and "over" a second feature may be directly on or obliquely above the second feature, or simply mean that the first feature is at a higher level than the second feature. A first feature "under," "beneath," and "under" a second feature may be directly under or obliquely under the second feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

As shown in FIG. 1, one embodiment of the present invention provides a stent graft system, comprising: the stent graft 100 and the beam diameter piece 200 arranged on the stent graft 100; the bundle diameter member 200 is used for restraining the stent graft 100 and can release the stent graft 100 (see fig. 2); wherein, the inner diameter of the covered stent 100 after being bound is smaller than the inner diameter after being released, and the covered stent 100 after being bound has a through inner cavity. FIG. 2 is a schematic view of the stent graft 100 after release of the proximal end via the bundle 200.

As an example, as shown in FIG. 1, a stent graft 100 includes: a metal support 110 and a coating film 120 covering the metal support 110; the stent graft 120 has at least one window for mounting a branch stent graft. The metal stent 110 is used to improve the adherence of the coating 120, and the metal stent 110 is made of biocompatible metal materials such as nickel-titanium alloy and stainless steel. As shown in fig. 7, the metal bracket 110 includes a plurality of support rings 111 arranged at intervals in the axial direction; the support ring 111 may be configured as a ring, a wave, etc., and it is understood that the wave-shaped support ring 111 is formed by connecting a plurality of support rods. The coating film 120 is made of polymer materials such as PET (Polyethylene terephthalate), ePTFE (Expanded Polytetrafluoroethylene) and the like, and the coating film 120 made of the materials has the advantages of compact structure, uniform texture, good blood seepage resistance, capability of being attached to blood vessels, good flexibility and capability of keeping the shape unchanged under the impact of blood flow.

As an example, as shown in FIG. 3, the proximal end of the stent graft 100 is provided with a bare metal stent 130, anchored with the proximal end. It should be noted that proximal in the whole text refers to the end close to the heart and distal refers to the end far from the heart.

The installation process of the stent graft system is described below with reference to the abdominal aortic aneurysm a shown in fig. 4, which involves the celiac trunk a1, the superior mesenteric artery a2, and the renal artery A3, wherein the stent graft 100 shown in fig. 3 comprises, in order from the proximal end to the distal end: a proximal stent graft 100a, a middle stent graft 100b and a distal stent graft 100c, wherein the junction between the proximal stent graft 100a and the middle stent graft 100b has two windows for installing a first branch stent graft 300 (see fig. 5 and 11) to the affected celiac trunk artery a1 and the superior mesenteric artery a2, respectively, and the junction between the middle stent graft 100b and the distal stent graft 100c has two windows for installing a second branch stent graft 400 (see fig. 5 and 11) to the affected left and right renal arteries A3, respectively:

when the device is applied, the covered stent 100 is bound by the diameter binding piece 200, so that the inner diameter of the covered stent 100 is reduced; the stent graft 100 is then delivered to the lesion of the abdominal aortic aneurysm a using a delivery system. When the stent graft 100 is introduced into the lesion, the outer tube of the delivery system is withdrawn until the stent graft 100 is completely exposed, so as to release the stent graft 100 to the lesion, and then the first branch stent graft 300 is passed through the lumen of the stent graft 100 from the proximal end of the proximal stent graft 100a by the delivery system, and introduced into the abdominal trunk artery a1 and the superior mesenteric artery a 2. During introduction of the first branch stent graft 300, the stent graft 100 may shift such that the first window is circumferentially offset from the orientation of the celiac trunk a1 and/or the superior mesenteric artery a2, at which time the stent graft 100 is in a state of a constrained diameter and released after the bare metal stent 130 is present, the stent graft 100 may be finely adjusted to achieve precise positioning, and then the proximal stent graft 100a is released through the constrained diameter member 200 to engage the proximal stent graft 100a with the blood vessel, and then the first branch stent graft 300 is released. Similarly, the second branch stent graft 400 is advanced from the distal end of the distal stent graft 100c into the lumen of the stent graft 100 and into the renal artery A3 using the delivery system. During introduction of the second branch stent graft 400, the stent graft 100 may shift such that the second window circumferentially deviates from the orientation of the renal artery a3, at this time, since the stent graft 100 is in the state of the bundle diameter and the bare metal stent 130 is released, the stent graft 100 may be finely adjusted to achieve precise positioning, and then the middle stent graft 100b and the distal stent graft 100c are released through the bundle diameter member 200 to attach the middle stent graft 100b and the distal stent graft 100c to the blood vessel, and then the second branch stent graft 400 is released. Finally, the bare metal stent 130 of the stent graft 100 is released, the delivery system of the stent graft 100 is withdrawn, and the release is complete. It should be noted that, in the process of introducing the first branch stent graft 300 and the second branch stent graft 400, the lumen bounded by the stent graft 100 can always ensure that blood flows smoothly through the lumen, so as to ensure the perfusion of the blood flow in the lumen of the stent graft 100, avoid related complications caused by ischemia in the main abdominal aorta lumen, and ensure the life safety of the patient.

The stent graft system can be used for treating complex abdominal aortic aneurysm A involving visceral artery, since the diameter-restricting member 200 can restrain the stent graft 100, after the stent graft system is introduced into the lesion site of the abdominal aortic aneurysm A, the covered stent 100 is not jointed with the blood vessel, the covered stent 100 can move between the near end and the far end after being restrained by the beam diameter part 200 until the first window of the covered stent 100 faces towards the celiac trunk artery A1 and/or the superior mesenteric artery A2 and the second window faces towards the renal artery A3, meanwhile, the covered stent 100 can still be adjusted in the process of guiding the branch covered stent into the channel to be beneficial to accurate positioning, and the covered stent 100 is provided with a through inner cavity after being bound, the inner cavity that link up makes the blood flow smoothly pass through, ensures the blood flow perfusion of tectorial membrane support 100 inner cavity, avoids because of the relevant complication that the abdominal aorta main cavity lacks blood and leads to.

In some embodiments of the present invention, the ratio of the bound inner diameter to the released inner diameter of the stent graft 100 is (1-4): 5, for example, the ratio can be 1:5, 2:5, 3:5, 4:5, etc. With such an arrangement, the lumen of the constrained stent graft 100 can be ensured to allow blood to pass smoothly, and the stent graft 100 can still move up and down for adjustment if the stent graft is displaced when the channels of the first branch stent graft 300 and the second branch stent graft 400 are established.

In some embodiments of the present invention, as shown in fig. 1 and 2, the beam member 200 includes: a guide wire 210 and a plurality of binding coils 220 spaced apart along the length of the guide wire 210; a cinch coil 220 is used to cinch the stent graft 100, the cinch coil 220 being removably connected to the guide wire 210 to enable release of the stent graft 100 when the guide wire 210 is withdrawn. Of course, in other embodiments of the present invention, the diameter-restricting member 200 may also be woven by a binding thread and sleeved outside the covered stent 100 in an interference fit manner, when the covered stent 100 is released, the diameter-restricting member 200 may be removed by pulling one end of the binding thread, and the removal principle is the same as the principle of removing a sweater, so as to achieve the purpose of releasing the covered stent 100.

The material of the binding coil 220 is not particularly limited in the embodiments of the present invention, as long as it has biocompatibility, and may be made of, for example, a polymer material such as PET (Polyethylene terephthalate), PTFE (Polytetrafluoroethylene), ePTFE (Expanded Polytetrafluoroethylene), PP (Polypropylene), or the like.

The material of the guide wire 210 is not particularly limited as long as it has a certain hardness and a certain flexibility, and may be, for example, the same material as the metal stent 110, and may be a biocompatible metal material such as nitinol or stainless steel.

The attachment between the cinch coil 220 and the guidewire 210 may be by way of either an adhesive or a slip knot. The latter is preferred by embodiments of the present invention based on the weakness of the former connection.

In particular, in some embodiments of the present invention, as shown in FIG. 8, the first end of the cinch coil 220 is rotated at least one revolution around the stent graft 100 and out the second end of the cinch coil 220; the guide wire 210 is inserted through a first end of the restraining coil 220 to fasten the restraining coil 220. The area a shown in fig. 8 is used for threading the guide wire 210 and the area B is used for winding the stent graft 100. When the guide wire 210 is pulled, the guide wire 210 is pulled out of the first end of the restraining coil 220, and the restraining coil 220 is loosened under the restoring force of the stent graft 100, thereby achieving the purpose of releasing the stent graft 100. It should be noted that the restraining wire 220 does not move with the guidewire 210, but remains within the lesion of the abdominal aortic aneurysm a, abutting between the vessel wall and the wall of the stent graft 100.

Optionally, the first end of the cinch coil 220 is rotated one revolution around the stent graft 100 to facilitate release of the cinch coil 220 from the stent graft 100 after the guidewire 210 is withdrawn. The cross-section of the restraining coil 220 is flat, which reduces the damage to the restraining coil 220 during restraining and releasing of the stent graft 100.

Alternatively, as shown in fig. 6 and 8, the plurality of binder coils 220 are formed by bending the same binder line M. Thus, the second ends of the plurality of binding coils 220 are located in the same direction, which facilitates the threading and pulling of the guide wire 210. Of course, in other embodiments of the present invention, the plurality of binding coils 220 may also be independent from each other, and the second end of the binding coil 220 may also be used to pass the guiding wire 210, that is, the first end and the second end of the binding coil 220 are both sleeved outside the guiding wire 210.

Wherein, regarding the above-mentioned binding line M can be bent to form 3 binding coils 220 as an example, the bending manner of the binding line M is described: first, the line segment between the points a and B, the line segment between the points C and D, and the line segment between the points E and F on the tether line M in fig. 9(a) are bent outward to form the structure shown in fig. 9(B), and then the points a and B, the points C and D, and the points E and F are connected in pairs to form the structure shown in fig. 9 (C). Alternatively, the attachment may be by means of gluing, stitching, and knotting. Of course, in other embodiments of the present invention, the line segment between the points a and B on the constraint line M may be bent outward and then the points a and B are connected to form one constraint coil 220, and then the remaining two constraint coils 220 are formed according to this step.

Further, as shown in FIGS. 6 and 7, in some embodiments of the present invention, a plurality of stationary coils 170 are disposed on the stent graft 100, and the constraining coils 220 are circumferentially inserted into the corresponding stationary coils 170. The stationary coil 170 may act as a stop for the cinching coil 220, which may not only enable the cinching member 200 to effectively cinch the stent graft 100, but also enable the cinching coil 220 to move along the stationary coil 170 to effectively release the stent graft 100 during the process of drawing the guide wire 210.

Alternatively, as shown in FIG. 7, the stationary coil 170 includes a plurality of stationary coil groups arranged in the axial direction of the stent graft 100, each of the stationary coil groups being distributed around the circumference of the stent graft 100 and the number of stationary coils of each of the stationary coil groups being at least 3. Thus, the number of the fixing coils 170 can be reduced, and the binding member 200 can be ensured to effectively bind the stent graft 100. It should be noted that when the cinching coil 220 is wound around the stent graft 100a plurality of turns, each turn is inserted into a corresponding stationary coil set.

Further, in some embodiments of the present invention, the stent-graft 100 includes a metal stent 110 and a stent-graft 120 covering the metal stent 110; as shown in FIG. 7, the suture between the metal stent 110 and the stent graft 120 is pulled out of the stent graft 100 to form a stationary coil 170. Thus, the binding coil 220 can bind the metal stent 110, and can effectively bind the entire stent graft 100. It is understood that the fixing coil 170 is a part of the suture thread between the metal stent 110 and the cover 120, and thus the material of the fixing coil 170 is the same as the material of the suture thread between the metal stent 110 and the cover 120.

Alternatively, as shown in fig. 2, 3 and 5, the metal bracket 110 includes: a plurality of support rings 111 arranged at intervals along the axial direction, wherein the support rings 111 are formed by connecting a plurality of support rods; the fixed coil 170 is positioned in the area where the length L of the supporting rod is 1/3-2/3 in proportion (see figure 7). Thus, the effective binding of the beam member 200 to different parts of the stent graft 100 can be ensured. Wherein, the support rod length L is the length of the support rod in the axial direction.

As shown in FIGS. 2, 3, 5, and 11, in some embodiments of the present invention, the stent graft 100 comprises, in order from the proximal end to the distal end: a proximal stent graft 100a, a middle stent graft 100b, and a proximal stent graft 100a, the middle stent graft 100b having a minimum inner diameter; at least one first window is arranged at the junction of the near-end covered stent 100a and the middle covered stent 100b, at least one second window is arranged at the junction of the middle covered stent 100b and the far-end covered stent 100c, and the first window and the second window are used for installing branch covered stents. The inner diameters of the near-end covered stent 100a and the far-end covered stent 100c are larger than that of the middle covered stent 100b, so that a space can be reserved for the branch covered stents, and the long-term patency of the branch covered stents is improved. In addition, the stent graft 100 provided with the first window and the second window can not only solve the problem of insufficient blood supply to visceral branches such as the celiac artery A1 and the superior mesenteric artery A2, but also cover the branch artery lesion, extend the proximal anchoring area, and solve the problems of too short a proximal tumor diameter and insufficient anchoring.

Optionally, as shown in fig. 6 and 10, the number of the first windows is two, two first windows are circumferentially distributed on the same side of the stent graft 100, and a distance between two adjacent first windows in the axial direction of the stent graft 100 is 0-30 mm (for example, 0mm, 5mm, 10mm, 15mm, 20mm, 25mm, 30mm, etc.); and/or, as shown in fig. 6 and 10, the number of the second windows is two, two second windows are circumferentially distributed on opposite sides of the stent graft 100, and the distance between two adjacent second windows in the axial direction of the stent graft 100 is 0-30 mm (for example, 0mm, 5mm, 10mm, 15mm, 20mm, 25mm, 30mm, etc.). In this way, the positional relationship between the two first windows can be made the same as the positional relationship between the celiac trunk a1 and the superior mesenteric artery a2, and the positional relationship between the two second windows can be made the same as the positional relationship between the two renal arteries A3, facilitating the branch stent graft to access the celiac trunk a1, the superior mesenteric artery a2, or the renal artery A3. In addition, the number of the branch covered stents introduced into the abdominal trunk artery a1, the superior mesenteric artery a2 and the two renal arteries A3 is 1, and in this case, the number of the first windows is at most two, and the number of the second windows is at most two.

Further, in some embodiments of the present invention, as shown in FIGS. 3 and 6, a first inset branch 140 is disposed at the first window, a second inset branch 150 is disposed at the second window, and both the first inset branch 140 and the second inset branch 150 are disposed within the stent graft 100. The first and

second branches

140, 150 have the same structure as the stent graft 100. The branch covered stent can be inserted into the first embedded branch 140 through the first window or inserted into the second embedded branch 150 through the second window, so that the occurrence of type III internal leakage can be effectively prevented.

Further, as shown in FIG. 3, in some embodiments of the present invention, the proximal edge of the proximal stent graft 100a, and/or the distal edge of the distal stent graft 100c, and/or the first window, and/or the second window are provided with a visualization portion 160. The development section 160 may precisely position the stent graft 100.

Optionally, the developing part 160 is made of at least one of tantalum, platinum-iridium alloy, and gold.

Alternatively, the developing part 160 may be fixed by sewing with a suture. The developing part 160 may have a ring shape, an "O" shape, or an "8" shape. The "8" -shaped developing unit 160 may be regarded as being formed by joining two "O" -shaped developing units 160, but two or more "O" -shaped developing units 160 may be joined to each other when applied. In addition, 1 ring-shaped development portion 160 may be provided at each of the proximal edge of the proximal stent graft 100a, the distal edge of the distal stent graft 100c, the first window, and the second window, or at least one "O" or "8" development portion 160 may be provided.

Example 1

The present example provides a stent-graft system for treating an abdominal aortic aneurysm a (see fig. 4) affecting the celiac trunk a1, the superior mesenteric artery a2, and the renal artery A3. As shown in FIGS. 3 and 5, the stent graft 100 comprises a proximal stent graft 100a, an intermediate stent graft 100b and a distal stent graft 100c which are connected in sequence, wherein the inner diameter of the intermediate stent graft 100b is the smallest; two first windows at the junction of the proximal stent graft 100a and the middle stent graft 100b are respectively provided with a first embedded branch 140 in the axial direction, two second windows at the junction of the middle stent graft 100b and the distal stent graft 100c are respectively provided with a second embedded branch 150, the two first windows are circumferentially distributed on the same side of the stent graft 100 in parallel, the axial distance is zero, the two second windows are circumferentially distributed on the opposite side of the stent graft 100 in parallel, and the axial distance is zero. Wherein, the material of the covering film 120 of the covered stent 100 is selected from polyester fabric (PET), polytetrafluoroethylene or other high polymer materials, and the penetration amount meets 0-500 mL/cm²The requirement of/min; the metal stent 110 of the covered stent 100 is made of nickel-titanium alloy wires or stainless steel materials and comprises a plurality of support rings arranged at intervals, the support rings are formed by connecting a plurality of V-shaped units, a bare metal stent 130 is arranged at the near end of the covered stent 100 and is beneficial to anchoring the near end。

The tethering coils 220 in FIG. 6 are ligated to the stationary coils 170 on the stent graft 100 via the guide wires 210, i.e., the tethering coils 220 are circumferentially inserted into the corresponding stationary coils 170, and the stent graft 100 bundle diameter, i.e., the guide wires 210, are inserted through the tethering coils 220 in the axial direction of the stent graft 100 with a bundle diameter ratio of 60% (i.e., the ratio of the inner diameter of the stent graft 100 after tethering to the inner diameter after release is 3: 5). The fixed coil 170 is located at the middle positions of the proximal stent graft 100a, the middle stent graft 100b and the distal stent graft 100c, and the proximal stent graft 100a, the middle stent graft 100b and the distal stent graft 100c are all provided with 4 coils.

In treatment, the stent graft 100 is first delivered to the lesion site of the abdominal aortic aneurysm a by using a delivery system. When the stent graft 100 is judged to be introduced to the lesion site based on the identification positioning of the visualization portion 160, the outer tube of the delivery system is first withdrawn until the stent graft 100 is completely exposed, so as to release the stent graft 100 to the lesion site. The first branch stent graft 300 is guided into the first embedded branch 140 from the proximal end of the proximal stent graft 100a by using a delivery system, and at this time, the bare metal stent graft 130 is released in a state of a beam diameter, and the stent graft 100 can be finely adjusted according to actual conditions, that is, at this time, if the first branch stent graft 300 is inaccurately positioned, the stent graft 100 can be finely adjusted between the proximal end and the distal end until the first branch stent graft 300 is accurately positioned, and then the guide wire 210 is pulled to release the proximal stent graft 100a (as shown in fig. 2), so that the proximal stent graft 100a is attached to a blood vessel, and then the first branch stent graft 300 is released. Repeating the above steps, namely, guiding the second branch stent graft 400 into the second embedded branch 150 from the distal end of the distal stent graft 100c by using a conveying system, at this time, releasing after the bare metal stent 130 is in a bundle diameter state, and the stent graft 100 can be finely adjusted according to actual conditions, namely, at this time, if the second branch stent graft 400 is not accurately positioned, finely adjusting the stent graft 100 between the proximal end and the distal end until the second branch stent graft 400 is accurately positioned, then pulling the guide wire 210 to release the middle-end stent graft 100b and the distal-end stent graft 100c, so that the middle-end stent graft 100b and the distal-end stent graft 100c are attached to the blood vessel, and then releasing the second branch stent graft 400. Finally, the bare metal stent 130 of the stent graft 100 is released, the delivery system of the stent graft 100 is withdrawn, and the release is complete.

Example 2

The present example provides a stent-graft system for treating an abdominal aortic aneurysm a (see fig. 4) affecting the celiac trunk a1, the superior mesenteric artery a2, and the renal artery A3. As shown in FIG. 11, the stent graft 100 comprises a proximal stent graft 100a, a middle stent graft 100b and a distal stent graft 100c in sequence from the proximal end to the distal end, wherein the middle stent graft 100b has the smallest inner diameter; as shown in fig. 10, two first windows at the boundary between the proximal stent graft 100a and the middle stent graft 100b are respectively provided with a first embedded branch 140 in the axial direction, two second windows at the boundary between the middle stent graft 100b and the distal stent graft 100c are respectively provided with a second embedded branch 150, the two first windows are spaced by 8mm in the axial direction of the stent graft 100 and circumferentially distributed on the same side of the stent graft 100, and the two second windows are spaced by 6mm in the axial direction of the stent graft 100 and circumferentially distributed on the opposite side of the stent graft 100. The tethering coils 220 in FIG. 10 are ligated to the stationary coils 170 on the stent graft 100 via the guide wires 210, i.e., the tethering coils 220 are circumferentially inserted into the corresponding stationary coils 170, and the stent graft 100 is bundled such that the guide wires 210 extend through the tethering coils 220 in the axial direction of the stent graft 100 at a bundle diameter ratio of 50% (i.e., the ratio of the inner diameter of the stent graft 100 after tethering to the inner diameter after release is 1: 2). In treatment, the stent graft 100 is first delivered to the lesion site of the abdominal aortic aneurysm A by using a delivery system. When the stent graft 100 is judged to be introduced to the lesion site based on the identified location of the visualization portion 160, the outer tube of the delivery system is first withdrawn until the stent graft 100 is completely exposed, so as to place the stent graft 100 on the lesion site. The first branch stent graft 300 is introduced from the carotid artery puncture, is penetrated from the proximal end of the proximal stent graft 100a and is introduced into the abdominal trunk A1 and the superior mesenteric artery A2 through the first embedded branch 140, and at the moment, whether the positioning of the first branch stent graft 300 is accurate is observed, if the positioning is not accurate, the first branch stent graft 100 can be finely adjusted between the proximal end and the distal end because the first branch stent graft 300 is released after the bare metal stent 130 is in the state of bundle diameter, and the positioning of the first branch stent graft 300 is accurate. The guide wire 210 is then pulled to release the proximal stent graft 100a, so that the proximal stent graft 100a is attached to the blood vessel, and then the first branch stent graft 300 is released. The above steps are repeated, i.e., the second branch stent graft 400 is guided into the second embedded branch 150 from the distal end of the distal stent graft 100c by using the delivery system, at this time, because the bare metal stent graft 130 is released in the state of the bundle diameter, the stent graft 100 can be finely adjusted according to actual conditions, i.e., if the second branch stent graft 400 is inaccurately positioned, the stent graft 100 can be finely adjusted between the proximal end and the distal end until the second branch stent graft 400 is accurately positioned, and then the guide wire 210 is firstly pulled to release the middle-end stent graft 100b and the distal stent graft 100c, so that the middle-end stent graft 100b and the distal stent graft 100c are attached to the blood vessel, and then the second branch stent graft 400 is released. Finally, the bare metal stent 130 of the stent graft 100 is released, the delivery system of the stent graft 100 is withdrawn, and the release is complete.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A stent graft system, comprising: a covered stent (100) and a beam diameter piece (200) arranged on the covered stent (100);

the bundle diameter piece (200) is used for binding the covered stent (100) and releasing the covered stent (100);

wherein the inner diameter of the covered stent (100) after being bound is smaller than the inner diameter after being released, and the covered stent (100) after being bound is provided with a through inner cavity.

2. The stent graft system of claim 1, wherein the ratio of the constrained inner diameter to the released inner diameter of the stent graft (100) is (1-4): 5.

3. the stent graft system of claim 1, wherein the bundle (200) comprises: a guide wire (210) and a plurality of binding coils (220) distributed at intervals along the length direction of the guide wire (210);

the restraining coil (220) is used for restraining the covered stent (100), and the restraining coil (220) is detachably connected with the guide wire (210) so that the covered stent (100) can be released when the guide wire (210) is pulled.

4. The stent-graft system according to claim 3, wherein the material of the restraint coil (220) is at least one selected from PET, PTFE, ePTFE, PP.

5. The stent graft system of claim 3, wherein the cinch coil (220) is connected to the guide wire (210) in a slip-knot manner.

6. The stent graft system of claim 5, wherein the first end of the cinch coil (220) rotates at least one turn around the stent graft (100) and exits the second end of the cinch coil (220);

the guide wire (210) is threaded through a first end of the cinching coil (220) to cinch the cinching coil (220).

7. The stent-graft system according to claim 6, wherein the plurality of binder coils (220) are bent by the same binder line (M).

8. The stent graft system of claim 3, wherein the stent graft (100) is further provided with a plurality of stationary coils (170), and the tie coils (220) are circumferentially arranged in the corresponding stationary coils (170).

9. The stent graft system of claim 8, wherein the stationary coil (170) comprises a plurality of stationary coil sets arranged in an axial direction of the stent graft (100), each of the stationary coil sets being distributed around a circumference of the stent graft (100) and a number of stationary coils of each of the stationary coil sets being at least 3.

10. The stent graft system of claim 8, wherein the stent graft (100) comprises: the metal bracket (110) and a coating film (120) covering the metal bracket (110);

the suture between the metal stent (110) and the stent graft (120) is pulled out to the outside of the stent graft (100) to form the fixed coil (170).

11. The stent-graft system of claim 10, wherein the metal stent (110) comprises: the support ring comprises a plurality of support rings (111) which are arranged at intervals along the axial direction, wherein the support rings (111) are formed by connecting a plurality of support rods;

the fixed coil (170) is located in the region where the length L proportion of the supporting rod is 1/3-2/3.

12. The stent graft system according to any one of claims 1 to 11, wherein the stent graft (100) comprises, in order from the proximal end to the distal end: a proximal stent graft (100a), an intermediate stent graft (100b), and a distal stent graft (100c), the intermediate stent graft (100b) having a minimum inner diameter;

the junction of the near-end covered stent (100a) and the middle covered stent (100b) is provided with at least one first window, the junction of the middle covered stent (100b) and the far-end covered stent (100c) is provided with at least one second window, and the first window and the second window are used for installing branch covered stents.

13. The stent graft system of claim 12, wherein the first window is provided with a first in-line branch (140), the second window is provided with a second in-line branch (150), and the first in-line branch (140) and the second in-line branch (150) are both located within the stent graft (100).

14. The stent graft system according to claim 12, wherein the number of the first windows is two, two of the first windows are circumferentially distributed on the same side of the stent graft (100), and the distance between two adjacent first windows in the axial direction of the stent graft (100) is 0-30 mm;

and/or the number of the second windows is two, the two second windows are circumferentially distributed on the opposite sides of the covered stent (100), and the distance between the two adjacent second windows in the axial direction of the covered stent (100) is 0-30 mm.

15. The stent graft system of claim 12, wherein the proximal edge of the proximal stent graft (100a), and/or the distal edge of the distal stent graft (100c), and/or the first window, and/or the second window are provided with a visualization portion (160).

16. The stent graft system of claim 15, wherein the visualization portion (160) is secured by suture stitching.