CN114681116B

CN114681116B - Lumen stent

Info

Publication number: CN114681116B
Application number: CN202011623767.1A
Authority: CN
Inventors: 刘堂杰; 肖本好; 方毅
Original assignee: Shenzhen Xianjian Changtong Medical Co ltd; Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2025-07-18
Anticipated expiration: 2040-12-30
Also published as: CN114681116A

Abstract

The present invention discloses a luminal stent, comprising a tube body and a skirt connected to the tube body, at least one anchoring portion is provided in the circumferential direction of the skirt, when a plurality of anchoring portions are provided on the skirt, the plurality of anchoring portions are arranged at intervals, and when only one anchoring portion is provided on the skirt, the anchoring portion surrounds a portion of the skirt in the circumferential direction. After the luminal stent is implanted in the main body coated stent, the skirt can be used to block the gap between the luminal stent and the window area on the main body stent, and the luminal stent is anchored by the anchoring portion; when a plurality of the luminal stents are implanted and the distance between the luminal stents is relatively close, since a single anchoring portion only surrounds a portion of the skirt in the circumferential direction, or a plurality of anchoring portions are arranged at intervals in the circumferential direction, the anchoring portions of adjacent luminal stents can be staggered to avoid the occurrence of poor blocking effects caused by overlapping or mutual extrusion and deformation between adjacent luminal stents.

Description

Lumen stent

Technical Field

The invention relates to the field of medical instruments, in particular to a lumen stent.

Background

Over ten years ago, aortic stent graft endoluminal isolation has been widely applied to lesions such as aneurysms and aortic dissection of the thoracic and abdominal aorta, has definite curative effect, small trauma, quick recovery and fewer complications, and has become the first-line treatment method. However, the use of stent-grafts for specific lesions such as aortic arch, celiac arterial trunk, bilateral renal arteries, or superior mesenteric arteries affects the blood supply to arterial branches. For this situation, the main body covered stent is usually windowed in situ by laser or mechanical means during the operation, so that the main body covered stent generates an expected hole, and then the branch stent is conveyed to the hole to be in butt joint with the main body covered stent. At present, a straight-tube type tectorial membrane bracket is basically selected as a branch bracket in the windowing operation type, but because a gap exists between a windowing area and the branch bracket, III-type internal leakage is easy to generate, and operation failure can be caused. As shown in fig. 1, blood in the aorta may flow into aortic dissection 1 through the gap between branch stent 10 and the fenestrated region of main body stent 20, creating a type III endoleak.

At present, a skirt edge tectorial membrane bracket is mainly adopted to replace a straight barrel type tectorial membrane bracket to solve the problems, namely, the skirt edge tectorial membrane bracket is additionally arranged on the basis of the straight barrel type tectorial membrane bracket, as shown in fig. 2, when the skirt edge tectorial membrane bracket is used as a branch bracket 10 to be implanted into a main body bracket 20, the skirt edges 11a and 11b are turned outwards to anchor the branch bracket 10 and block a gap between the branch bracket 10 and a windowing area on the main body bracket 20, so that III-type internal leakage is prevented. However, when a plurality of branch stents 10 are implanted and the distance between the branch stents 10 is relatively short, the flanges 11a, 11b of the adjacent branch stents 10a, 10b turned outwards may overlap each other or be deformed by extrusion, thereby resulting in poor sealing effect of the gap between the branch stents 10a, 10b and the fenestration area of the main stent 20.

Disclosure of Invention

Based on this, it is necessary to provide a lumen stent to avoid the problem of poor sealing effect caused by overlapping of the outwardly turned skirts or mutual extrusion deformation between adjacent stents.

The invention provides a lumen stent, which comprises a tube body and a skirt edge connected with the tube body, wherein at least one anchoring part is arranged on the periphery of the skirt edge, when a plurality of anchoring parts are arranged on the skirt edge, the anchoring parts are arranged at intervals, and when only one anchoring part is arranged on the skirt edge, the anchoring part circumferentially surrounds a part of the skirt edge.

In one embodiment, one end of the anchoring portion is a fixed end connected to the skirt, the other end of the anchoring portion is a free end, the free end is located at a proximal end side of the fixed end when the anchoring portion is accommodated in the conveying device, and the free end moves to a distal end side after the anchoring portion is released from the conveying device, so that the anchoring portion turns outwards.

In one embodiment, the skirt is a hollow tube with two open ends, the skirt comprises a first supporting structure and a covering film arranged on the first supporting structure, the distal end of the skirt is in sealing connection with the outer surface of the tube body, and the cross-sectional area of the skirt gradually increases along the direction from the distal end to the proximal end of the skirt.

In one embodiment, the anchoring portion includes a second support structure having shape memory properties that extends outwardly from the proximal end of the skirt when the luminal stent is in a natural deployed state.

In one embodiment, the first support structure is integrally formed with the second support structure.

In one embodiment, the anchoring portion further comprises a connector integrally formed with the second support structure, and the second support structure is connected to the first support structure by the connector.

In one embodiment, the included angle formed between the second support structure and the bus bar of the skirt is in the range of 30-90 degrees.

In one embodiment, an included angle formed between the bus bar of the skirt and the central axis of the skirt is 10-80 degrees.

In one embodiment, at least one developer is provided on each of the anchors.

In one embodiment, a coating is provided on the second support structure.

In one embodiment, the free end of the anchor portion is bent toward the first side to form an arcuate structure on the second side of the anchor portion.

In one embodiment, the sum of occupancy of the anchoring portion in the circumferential direction of the skirt is 50% or less.

In one embodiment, the tube body includes a rounded proximal opening, and the ratio between the length of the generatrix of the skirt and the diameter of the proximal opening is in the range of 0.5 to 1.2.

In one embodiment, the tube body includes a rounded proximal opening, and the ratio between the length of the anchoring portion and the diameter of the proximal opening ranges from 0.4 to 1.

After the main body tectorial membrane bracket is implanted, the clearance between the main body tectorial membrane bracket and the upper windowing area of the main body tectorial membrane bracket can be plugged by the skirt edge, and the anchoring of the main body tectorial membrane bracket is realized by the anchoring part. When a plurality of the lumen stents are implanted and the distances between the lumen stents are relatively close, because the single anchoring portion only surrounds a part of the skirt edge in the circumferential direction or the plurality of anchoring portions are arranged at intervals in the circumferential direction, gaps are reserved around the anchoring portions, and the anchoring portions of adjacent lumen stents can be staggered, so that the occurrence of poor blocking effect caused by overlapping or mutual extrusion deformation between the adjacent lumen stents is avoided.

Drawings

FIG. 1 is a schematic view of a prior art branch stent in butt joint with a main body stent;

FIG. 2 is a schematic view of another prior art branch stent after docking with a main body stent;

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

FIG. 4 is a schematic view of a lumen stent according to another embodiment of the present invention;

FIG. 5 is a top view of the lumen stent of FIG. 3;

FIG. 6 is a schematic view of the shape of a skirt according to one embodiment of the present invention;

FIG. 7 is a schematic view of the first support structure and anchor of FIG. 3 deployed in the same plane;

FIG. 8 is a schematic view of a skirt and anchor provided in accordance with one embodiment of the present invention;

FIG. 9 is a schematic view of a skirt and anchor according to another embodiment of the present invention;

FIG. 10 is a schematic view of a skirt and anchor according to yet another embodiment of the present invention;

FIG. 11 is a top view of the skirt and anchor of FIG. 10;

FIG. 12 is a top view of a skirt and anchor provided by another embodiment of the present invention;

FIG. 13 is a schematic view of a second arc structure according to an embodiment of the present invention;

FIG. 14 is a schematic view of a lumen stent according to an embodiment of the present invention after docking with a main body stent;

fig. 15 is a schematic diagram showing the positional relationship of the anchoring portions of adjacent luminal stents after the multiple luminal stents are docked with the main stent according to an embodiment of the present invention.

Detailed Description

In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that 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 "outer," "inner," "end," "circumferential," "axial," "upper," "side," "proximal," "distal," and the like are used herein for illustrative purposes only.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

In order to make the technical solution of the present application better understood by those skilled in the art, the technical solution will be clearly and completely described in the following in connection with the embodiments of different types of end structures of the stent, and further, this embodiment is only a part of the embodiments of the present application, but not all the embodiments. In addition, in describing a blood vessel, the direction may be defined according to the direction of blood flow, and in the present application, blood flow is defined to flow from the proximal end to the distal end, and in describing a stent, the inflow end of the stent is defined as the proximal end and the outflow end is defined as the distal end. The specific embodiments of the lumen stent are as follows:

as shown in fig. 3, an embodiment of the present invention provides a lumen stent 30, the lumen stent 30 comprising a tube 31 and a skirt 32 connected to the tube 31.

Specifically, the tube 31 is a hollow tube with two open ends, and includes a support frame and a tube film provided on the support frame. When the lumen stent 30 is implanted in a lumen, the tube 31 may serve as a blood flow channel. The support framework has radial expansion capability, can realize radial contraction under the action of external force, and can restore to an original shape and maintain the original shape by self-expansion or mechanical expansion (such as balloon expansion) after the external force is removed, thereby being capable of being tightly attached to the inner wall of the lumen through the radial supporting force after being implanted into the lumen. For example, the support frame may be a plurality of axially arranged wave rings (not shown), a mesh structure formed by braiding, or a cut mesh structure formed by cutting. The support matrix may be made of a metallic elastic material including known materials implanted in medical devices or combinations of various biocompatible materials, such as alloys of two or more single metals of cobalt, chromium, nickel, titanium, magnesium, iron, and 316L stainless steel, nitinol, tantalum alloy, etc., or other biocompatible metallic materials. The tube body covering film can be made of high polymer materials with good biocompatibility such as polytetrafluoroethylene (Poly tetra fluoroethylene, PTFE for short), polyethylene terephthalate (Polyethylene terephthalate, PET for short) and the like, and can be covered on the inner wall and/or the outer wall of the supporting framework in a sewing or hot melting mode and the like to play roles in reconstructing a fluid channel, isolating a lesion region of a lumen and the like.

The skirt 32 is a hollow tube with two open ends, and comprises a first supporting structure 321 and a skirt covering film 322 arranged on the first supporting structure 321, wherein the distal end of the skirt 32 is one end with smaller cross-sectional area, the proximal end of the skirt 32 is one end with larger cross-sectional area, and the cross-sectional area of the skirt 32 gradually increases along the direction from the distal end to the proximal end of the skirt 32. Where cross-sectional area refers to the area of a cross-section taken in a plane perpendicular to the axis of skirt 32.

The skirt edge 32 can be sleeved on the outer wall of the tube body 31, the distal end of the skirt edge 32 is in sealing connection with the outer wall of the tube body 31, so that a proximal opening of the tube body 31 is positioned between the proximal opening and the distal opening of the skirt edge 32, a gap is formed between the outer wall of the tube body 31 and the inner wall of the skirt edge 32, after the tube body is implanted, blood flows into the lumen stent 30 from the proximal end and simultaneously flows into the gap, and the blood flowing into the gap further plays a role in sealing and filling because the distal end of the skirt edge 32 is in sealing connection with the outer wall of the tube body 31. As shown in fig. 4, the distal end of the skirt 32 may also be directly sealingly connected to the proximal edge of the tube 31 such that the proximal opening of the tube 31 is located near the distal opening of the skirt 32, and therefore, the skirt 32 covers only a very small portion of the tube 31, or covers little of the tube 31, resulting in a smaller radially compressed skirt 32 position, which reduces the difficulty of sheathing and releasing the lumen stent 30. In other embodiments, the tube 31 extends from the proximal opening of the skirt 32, i.e., the proximal opening of the skirt 32 is located distally of the proximal opening of the tube 31. The connection between the skirt 32 and the tube 31 may be achieved by heat-fusing the skirt film 322 and the tube film, or by sewing the distal end of the skirt 32 to the tube 31.

In this embodiment, the skirt 32 may be frustoconical (or flare-like), and the skirt 32 may be sealed circumferentially by radial support forces. When the skirt angle β of the skirt 32 (the skirt angle refers to the angle formed between the bus of the skirt 32 and the central axis of the skirt 32) is too large, the radial supporting force of the lumen will be too large after the implantation of the lumen, so that the stimulation to the inner wall of the lumen is too large, and the damage to the inner wall of the lumen may be more serious. When the skirt angle β of the skirt 32 is too small, the blocking effect of the skirt 32 is poor. Therefore, in the present embodiment, the skirt angle β is set to 10 ° to 80 °, which can avoid the excessive irritation and damage of the skirt 32 to the inner wall of the lumen, and has a better plugging effect. Further, the skirt 32 may have a circular cross-sectional shape as shown in FIG. 5, an oval cross-sectional shape as shown in FIG. 6, or any other suitable shape. When the skirt 32 has an elliptical cross-sectional shape, the skirt 32 can more closely conform to the inner wall of a blood vessel having a cross-section similar to that of an ellipse, and thus the irritation of the skirt 32 to the inner wall of the blood vessel can be reduced.

The first support structure 321 includes at least one ring of undulating rings. As shown in fig. 3 and 5, the first support structure 321 includes only one ring of wavy ring, and the wavy ring includes two wavy elements 323 circumferentially arranged, each wavy element 323 includes two proximal vertices 326, three distal vertices 325, two endpoints 327 (the two endpoints 327 are the starting points and the ending points of the wavy elements 323 respectively), and a wavy bar 328 connecting the adjacent proximal vertices 326 and the distal vertices 325, a wavy bar 328 connecting the endpoints 327 and the adjacent distal vertices 325. Wherein, the proximal apexes 326 correspond to the peaks of the waveform, the distal apexes 325 correspond to the troughs of the waveform, two proximal apexes 326 and two end points 327 are located on the plane a (not shown), and three distal apexes 325 are located on the plane b (not shown).

In other embodiments, for the number of waveform cells 323 in the waveform ring, three waveform cells 323 may be provided as shown in fig. 8, four waveform cells 323 may be provided as shown in fig. 9, and one waveform cell 323 may be provided as shown in fig. 11. The number of the proximal vertices 326 and the distal vertices 325 in the waveform unit 323 can be set according to a specific application scenario with reference to fig. 5, which is not limited by the present invention.

In this embodiment, the first support structure 321 is configured to include only one ring of wavy ring, which is favorable to reduce the size of the first support structure 321 after radial compression, so as to reduce the sheathing and release difficulty of the lumen stent 30. It will be appreciated that in other embodiments, the first support structure 321 may also comprise a plurality of undulating rings arranged axially along the skirt 32, preferably connected in a net-like configuration. Of course, the loops may be arranged at intervals in parallel, but it should be noted that when the loops are arranged at intervals in parallel and connected to each other only by the skirt cover film 322, the interval between adjacent loops should not be too large, so that any proximal vertex 326 of any one loop (hereinafter referred to as loop M) is located between the cross section of the proximal vertex 326 of the loop adjacent to M (hereinafter referred to as loop N) and the cross section of the distal vertex 325 of N (i.e. any proximal vertex 326 of M is located in loop N), so as to avoid the proximal portion of the skirt 32 from being turned over after the skirt 32 is released from the delivery device (such as a sheath tube) due to the excessive interval between adjacent loops MN. The wavy annulus may be made of a metallic elastic material, such as an alloy of two or more single metals of cobalt, chromium, nickel, titanium, magnesium, iron, and 316L stainless steel, nitinol, tantalum alloy, etc., or other biocompatible metallic materials.

The skirt cover film 322 may be made of a polymer material with good biocompatibility, such as polytetrafluoroethylene (Poly tetra fluoroethylene, abbreviated as PTFE), polyethylene terephthalate (Polyethylene terephthalate, abbreviated as PET), and the skirt cover film 322 may be covered on the inner wall and/or the outer wall of the first support structure 321 by stitching or hot melting, so as to play a role in blocking. As shown in fig. 3, in the present embodiment, the skirt cover film 322 completely covers the first support structure 321. It should be appreciated that the skirt cover film 322 may also partially cover the first support structure 321. Compared with the skirt cover film 322 partially covering the first supporting structure 321, the skirt cover film 322 completely covering the first supporting structure 321 can achieve better blocking effect.

At least one anchor portion 33 is provided in the peripheral direction of the skirt 32. When the skirt 32 is provided with a plurality of anchor portions 33, the anchor portions 33 are arranged at intervals. Specifically, as shown in fig. 3, two anchoring portions 33 are provided on the skirt 32 in a spaced apart manner, as shown in fig. 8, three anchoring portions 33 are provided on the skirt 32 in a spaced apart manner, and as shown in fig. 9, four anchoring portions 33 are provided on the skirt 32 in a spaced apart manner. The greater the number of anchoring portions 33, the more anchoring, but too many anchoring portions 33 may result in closer spacing between the anchoring portions 33, and when multiple luminal stents 30 are desired, the space available for placement of the anchoring portions 33 by adjacent luminal stents 30 is reduced. In addition, the plurality of anchoring portions 33 shown in fig. 3, 8 and 9 are circumferentially uniformly spaced and equally sized and shaped, which advantageously provides a relatively uniform anchoring force to the luminal stent 30. It will be appreciated that in some embodiments, the plurality of anchors 33 may also be unevenly spaced, and that the shape and size of the plurality of anchors 33 on the same luminal stent 30 may also be different. As shown in fig. 12, when only one anchor portion 33 is provided on the skirt 32, the anchor portion 33 circumferentially surrounds a portion of the skirt 32.

Referring to fig. 3, one end of the anchor portion 33 is a fixed end 33a connected to the skirt 32, the other end of the anchor portion 33 is a free end 33b, and when the anchor portion 33 is accommodated in the delivery device, the free end 33b is located on the proximal side of the fixed end 33a (i.e., on the side of the fixed end 33a near the proximal end of the lumen stent 30), and after the anchor portion 33 is released from the delivery device, the free end 33b is moved toward the distal side (i.e., on the side of the fixed end 33a near the distal end of the lumen stent 30) to turn the anchor portion 33 outward.

The anchor 33 includes a second support structure 331. In one embodiment, the second support structure 331 is made of a shape memory metal material (e.g., nickel titanium alloy), and may be a metal frame or foil in one or more of a zigzag, finger, and fan shape, or any other suitable shape. The second support structure 331 includes a first end and a second end connected to the skirt 32, where the second support structure 331 is pre-shaped, so that when the lumen stent 30 is in a natural unfolded state (the natural unfolded state refers to a natural unfolded state without being acted by an artificial external force), the second support structure 331 extends outwards from the skirt 32, and in the process of accommodating the second support structure 331 in the conveying device, the conveying device drives the first end of the second support structure 331 to move proximally and in a direction close to the central axis of the lumen stent 30, so that the first end of the second support structure 331 is located at the proximal side of the second end, and after the second support structure 331 is released from the conveying device, the first end of the second support structure 331 moves distally, so that the second support structure 331 is turned outwards to restore the pre-shaped form of the second support structure 331, at this time, an included angle α is formed between the second support structure 331 and the bus of the skirt 32 (i.e., an included angle α formed between the plane in which the second support structure 331 is located and the bus of the skirt 32).

Referring to fig. 3, the second support structure 331 may be integrally formed with the first support structure 321, when the lumen stent 30 is in the natural unfolded state, the second support structure 331 extends outward from the proximal end of the skirt 32, and the second support structure 331 is pre-formed (e.g. by heat treatment) such that an included angle is formed between the plane of the second support structure 331 and the bus bar of the skirt 32. Specifically, the first support structure 321 and the second support structures 331 may be cut from a metal tube or may be wound from a metal wire, where the metal tube or the metal wire has shape memory characteristics (e.g., the metal tube or the metal wire may be a shape memory alloy such as nitinol). As shown in fig. 5, the two second support structures 331 are disposed opposite each other, and each includes two support rods 334. One support bar 334 of the second support structure 331 is connected to an end point 327 of one wave unit 323, and the other support bar 334 is connected to an end point 327 of the other wave unit 323.

Referring to fig. 10, in another embodiment, the first support structure 321 and the second support structure 331 are not integrally formed, and the two second support structures 331 are disposed opposite to each other, each including two support rods 334, and are formed by winding a metal wire with shape memory property. The anchor portion 33 further comprises a connecting member 333, wherein one end of the connecting member 333 is connected to the second support structure 331, and the other end is connected to the first support structure 321. Specifically, the connecting member 333 includes two connecting wires integrally formed with the second support structure 331, and the two connecting wires are respectively wound around the two waverods 328 of the first support structure 321. When the lumen stent 30 is in the natural deployed state, the second support structure 331 extends outwardly from the proximal end of the skirt 32, and the second support structure 331 is pre-shaped such that an included angle is formed between the second support structure 331 and a bus bar of the skirt 32. It should be noted that the connection manner of the connecting member 333 and the first support structure 321 is not limited to the manner shown in fig. 10, and the connecting member 333 and the first support structure 321 may be fixedly connected by braiding, stitching, welding, or the like.

In this embodiment, referring to FIG. 7, in order to ensure that the anchoring portion 33 has a sufficient anchoring force, the length L1 of the anchoring portion 33 should satisfy 0.4D1≤L1≤D1, where D1 (not shown) is the diameter of the proximal opening of the tubular body 31 in a circular shape. Referring to FIG. 3, in order to ensure a good sealing effect of the skirt 32 and to reduce the difficulty of sheathing, the length L2 of the skirt 32 (i.e., the length of the bus bar of the skirt 32, not shown) should satisfy 0.5D1≤L2≤ 1.2D1.

Referring to FIG. 5, in the present embodiment, the sum of the occupation ratios M of the anchor portion 33 in the circumferential direction of the skirt 32 is 50% or less, and the calculation method of the occupation ratio of the anchor portion 33 in the circumferential direction of the skirt 32 is to calculate the length L3 of a circular arc where the anchor portion 33 intersects the skirt 32, and calculate the circumference L4 of the cross section of the skirt 32 on the plane in which the circular arc is located, and calculate the occupation ratio M of the anchor portion 33 in the circumferential direction of the skirt 32 by the following formula:

M=L3÷L4X100%

The sum of the occupancy M of all the anchor portions 33 in the lumen stent 30 is obtained by summing the occupancy of the anchor portions 33 in the circumferential direction of the skirt 32.

It will be appreciated that the length units of L3 and L4 need to be unified before calculating the occupancy M of the anchoring portion 33 in the circumferential direction of the skirt 32.

It should be noted that, in calculating the arc length L3 of the intersection of the anchoring portion 33 and the skirt 32, if the second support structure 331 of the anchoring portion 33 includes two support rods 334 and the gap between the two support rods 334 is not covered, the anchoring portion 33 should be regarded as a whole (i.e. including the gap between the two support rods 334 on the plane of the anchoring portion 33) to intersect the skirt 32, instead of intersecting the skirt 32 with the two support rods 334.

The length L2 of the anchor portion 33 may be suitably reduced in the range 0.4D1≤L2≤D1 as the circumferential occupancy M of the skirt 32 is higher.

In this embodiment, in order to reduce the probability that the second support structure 331 damages the inner wall of the main body support 20 and is corroded and decomposed by body fluid and tissues, the anchoring portion 33 further includes an anchoring section coating 332 provided on the second support structure 331. As shown in fig. 5, the anchor section coating film 332 completely covers the two support rods 334 of the second support structure 331 and the gap between the two support rods 334, the double-layer anchor section coating film 332 may be used to completely cover the gap between the two support rods 334 and the two support rods 334 between the anchor section coating film 332, or a single-layer anchor section coating film 332 may be used to cover the side of the second support structure 331 contacting the inner wall of the main body support 20. In other embodiments, the anchor segment coating 332 may also cover only the support bars 334 of the second support structure 331, without covering the gaps between the support bars 334, by which is meant that the support bars 334 are completely covered and wrapped. The anchor segment cover 332 may also cover only a portion of the support rods 334 and the gaps between the support rods 334.

In this embodiment, the first end of the second support structure 331 has a rounded outer contour, as shown in fig. 5, and the first end of the second support structure 331 has a first arc-shaped structure 335 connecting two support rods 334, which can prevent the second support structure 331 from damaging the inner wall of the main body support 20 during the releasing process of the lumen support 30.

In this embodiment, at least one developing member (not shown) is provided on each anchor 33 to enable positioning of the anchor 33 during release of the luminal stent 30. In order to more precisely position the edge of the anchor portion 33, a plurality of developing members may be provided at the edge position of the anchor portion 33, for example, on each support bar 334. The developing member may be provided by coating, plating, or winding a developing material on the anchor portion 33.

When a plurality of the above-mentioned lumen stents 30 are combined for use in the fenestration, the size and positional relationship of the blood vessel related to the patient are measured before the operation, a plurality of lumen stents 30 of appropriate size and structure are selected, one of the lumen stents 30 is accommodated in a delivery device, and the lumen stent 30 is delivered to a predetermined position (lumen of the main body stent 20) by the delivery device. The lumen stent 30 is then gradually released from the proximal end to the distal end by the delivery means, and when the anchoring portion 33 is fully released, the anchoring portion 33 forms an angle α with the generatrix of the skirt 32. The delivery device is pulled in the opposite direction to the feeding direction so that the lumen stent 30 moves synchronously with the delivery device, the anchoring portion 33 is hooked with the inner wall near the windowed region of the main body stent 20, and the delivery device is pulled further so that the anchoring portion 33 turns proximally until the anchoring portion 33 is attached to the inner wall of the main body stent 20. The releasing position of each anchoring portion 33 can be determined by the developing member on the anchoring portion 33, and when the releasing position of the anchoring portion 33 is not in line with the expectation, the lumen stent 30 can be rotated by rotating the conveying device to adjust the position of the anchoring portion 33. Then, the delivery device is pulled appropriately to make the anchor portion 33 more closely fit the inner wall of the main body stent 20 (refer to fig. 14), and then the rest of the lumen stent 30 is gradually released to complete the implantation of the lumen stent 30. With reference to the above method, implantation of the remaining luminal stent 30 continues. The anchoring portions 33 between adjacent luminal stents 30 may be in a parallel or mirror image positional relationship, and fig. 15 illustrates various positional relationships of the anchoring portions 33 of adjacent luminal stents 30, with reference to which the luminal stent 30 can be released. It will be appreciated that, since the single anchoring portion 33 circumferentially surrounds only a portion of the skirt 32, or a plurality of anchoring portions 33 are circumferentially spaced apart, gaps are provided around the anchoring portions 33, whereby the occurrence of poor sealing effects due to overlapping or mutual compression deformation between adjacent ones of the lumen stent 30 can be avoided by staggering the anchoring portions 33 of adjacent ones of the lumen stent 30.

It will be appreciated that when no visualization element is provided on the anchoring portion 33, the anchoring portion 33 may be adjusted to a predetermined position in vitro according to the size and positional relationship of the relevant blood vessel of the patient, and the anchoring portion 33 may be loaded into the delivery device according to the predetermined position, thereby releasing the anchoring portion 33 at the predetermined position.

In addition, referring to fig. 3, an included angle α formed between the anchoring portion 33 and the bus bar of the skirt 32 may not be too large, and an excessive included angle α may cause an insufficient anchoring force of the anchoring portion 33, resulting in displacement of the lumen stent 30, and an included angle α formed between the anchoring portion 33 and the bus bar of the skirt 32 may not be too small, and an excessively small included angle α may cause the anchoring portion 33 to be able to turn over proximally when an operator pulls the delivery device in a direction opposite to the feeding direction after the anchoring portion 33 is completely released, so that the anchoring portion 33 cannot be attached to the inner wall of the main stent 20. Therefore, the angle α formed between the anchor portion 33 and the bus bar of the skirt 32 is preferably set to 30 ° to 90 °.

Further, referring to fig. 13, the free end 33b of the anchoring portion 33 is bent toward the first side to form a second circular arc structure 336 on the second side of the anchoring portion 33, wherein the first side of the anchoring portion 33 is a side of the anchoring portion 33 facing the proximal end when the lumen stent 30 is in the natural deployment state, and the second side of the anchoring portion 33 is a side of the anchoring portion 33 facing the distal end when the lumen stent 30 is in the natural deployment state. The second rounded structure 336 facilitates smooth proximal eversion of the anchor 33 when the operator pulls the delivery device in a direction opposite the delivery direction after the anchor 33 is fully released.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. A luminal stent, comprising a tube body and a skirt connected to the tube body, characterized in that at least one anchoring portion is provided on the skirt in the circumferential direction, when a plurality of anchoring portions are provided on the skirt, the plurality of anchoring portions are arranged at intervals, and when only one anchoring portion is provided on the skirt, the anchoring portion surrounds a portion of the skirt in the circumferential direction;

One end of the anchoring portion is a fixed end connected to the skirt, and the other end of the anchoring portion is a free end. When the anchoring portion is accommodated in the delivery device, the free end is located at the proximal side of the fixed end. After the anchoring portion is released from the delivery device, the free end moves toward the distal side to make the anchoring portion flip outward.

The anchoring portion includes a second supporting structure with shape memory characteristics, and the angle formed between the second supporting structure and the generatrix of the skirt is 30° to 90°.

2. The luminal stent according to claim 1 is characterized in that the skirt is a hollow tube with openings at both ends, the skirt includes a first supporting structure and a coating provided on the first supporting structure, the distal end of the skirt is sealed and connected to the outer surface of the tube body, and the cross-sectional area of the skirt gradually increases from the distal end to the proximal end of the skirt.

3 . The luminal stent according to claim 2 , wherein when the luminal stent is in a naturally expanded state, the second supporting structure extends outward from the proximal end of the skirt.

4 . The endoluminal stent according to claim 3 , wherein the first supporting structure and the second supporting structure are integrally formed.

5 . The endoluminal stent according to claim 3 , wherein the anchoring portion further comprises a connecting piece, the connecting piece and the second supporting structure are integrally formed, and the second supporting structure is connected to the first supporting structure via the connecting piece.

6 . The endoluminal stent according to claim 1 , wherein the angle formed between the generatrix of the skirt and the central axis of the skirt is 10° to 80°.

7 . The endoluminal stent according to claim 1 , wherein the free end of the anchoring portion is bent toward the first side to form an arc-shaped structure on the second side of the anchoring portion.

8 . The endoluminal stent according to claim 1 , wherein the total occupancy rate of the anchoring portion in the circumferential direction of the skirt is less than or equal to 50%.

9 . The endoluminal stent according to claim 2 , wherein the tube body comprises a circular proximal opening, and a ratio between a generatrix length of the skirt and a diameter of the proximal opening is in a range of 0.5 to 1.2.

10 . The endoluminal stent according to claim 1 , wherein the tube body comprises a circular proximal opening, and a ratio between a length of the anchoring portion and a diameter of the proximal opening is in a range of 0.4 to 1.