Luminal stent

Abstract

The present invention discloses a tubular stent, comprising a tubular body and a semi-release device connected to the tubular body, wherein the tubular body comprises a corrugated ring, and the semi-release device comprises a restraining unit, wherein the restraining unit comprises a plurality of restraining wire bundles. When the restraining wire bundles extend along the circumference of the tubular body and apply a radial restraining force to the corrugated ring, within the axial interval where the corrugated ring is located, the points of application of the radial restraining force of each restraining wire bundle on the corrugated ring can be connected along the extension direction of the corresponding restraining wire bundle and form a connecting line, thereby forming a plurality of connecting lines corresponding to the plurality of restraining wire bundles, with at least two connecting lines spaced apart in the axial direction of the tubular body. The beneficial effect of the present invention is that when the plurality of restraining wire bundles radially restrain the corrugated ring, the corrugated ring is subjected to a more balanced force at both ends along its axial direction, thereby improving the accuracy of the axial and circumferential positioning of the tubular stent.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a lumen stent. Background Art

[0002] Over the past decade, endovascular exclusion with aortic stent grafts has been widely used for thoracic and abdominal aortic aneurysms and dissections. Its proven efficacy, minimal invasiveness, rapid recovery, and minimal complications have made it a first-line treatment. During the procedure, under X-ray fluoroscopy, the stent graft is delivered to the lesion via a delivery system. The stent graft isolates blood flow from the lesion, eliminating the effects of blood pressure on the lesion and ultimately achieving a cure.

[0003] In order to solve the positioning problem of the stent graft in the body, development marks are usually made at key positions of the stent, and the development marks are used to position the stent graft axially and circumferentially. However, when the stent graft is compressed in the delivery sheath, it has compression wrinkles in the circumference and is in an elongated state in the axial direction. If it is positioned by development marks at this time, there will be large circumferential and axial deviations. Therefore, in the prior art, the stent graft is radially constrained by a binding harness, so that the stent graft is in a semi-released state. When the stent graft is in the semi-released state, its outer diameter is larger than the outer diameter when loaded in the conveyor, and the outer diameter is smaller than the outer diameter of the stent graft when it is fully released and anchored in the human body's lumen. Compared with positioning the position of the stent graft by a development structure when the stent graft is loaded in the conveyor, the outer diameter of the stent graft when it is in the semi-released state is closer to the outer diameter when it is fully released, and positioning by the development structure will also be more accurate. Such as Figure 1 As shown, when the constraint line 2 is located near one end of the wave circle 1 ( Figure 1 When the wave ring 1 is constrained (as shown in the figure, the wave trough is constrained), it is easy to cause the wave crest of the wave ring 1 that is not constrained by the constraint line 2 to tilt outward, causing the outer diameter of the wave crest to be equal to or close to its fully released outer diameter, which is equivalent to the tilted part of the wave ring 1 being fully released in advance, causing the tilted part to be in anchoring contact with the lumen wall (such as the blood vessel wall), thereby making it impossible to adjust the axial and circumferential positions of the coated stent. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a luminal stent in view of the above-mentioned defects of the prior art.

[0005] The technical solution adopted by the present invention to solve its technical problem is:

[0006] A tubular stent is provided, comprising a tubular body and a semi-release device connected to the tubular body, wherein the tubular body comprises a corrugated ring, the semi-release device comprises a restraining unit, and the restraining unit comprises a plurality of restraining wire bundles. When the restraining wire bundles extend along the circumference of the tubular body and apply a radial restraining force to the corrugated ring, within an axial interval where the corrugated ring is located, the points of application of the radial restraining force of each restraining wire bundle on the corrugated ring can be connected along the extension direction of the corresponding restraining wire bundle to form a connecting line, thereby forming a plurality of connecting lines corresponding to the plurality of restraining wire bundles, and at least two of the connecting lines are spaced apart in the axial direction of the tubular body.

[0007] In summary, a tubular stent implementing the present invention has the following beneficial effects: the present application sets the points of action of the radial restraint force exerted by the multi-strand restraint harness on the corrugated ring to be located on at least two connecting lines with a distance therebetween, so that the number of force points of the corrugated ring along the axial direction of the corrugated ring will increase, and thus when the multi-strand restraint harness radially restrains the corrugated ring, the corrugated ring will be subjected to more balanced force at both ends along its axial direction, thereby preventing the end of the corrugated ring from warping outward relative to the other end, and further preventing the part causing the warping from being anchored to the tubular wall, so that the tubular stent has good stability in a semi-released state and can continue to adjust its position, thereby improving the accuracy of the axial and circumferential positioning of the tubular stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:

[0009] Figure 1 This is a schematic diagram of the structure of the end of the corrugated ring in the current technology;

[0010] Figure 2 This is a schematic diagram of the structure of binding the center coil of a corrugated ring in the prior art;

[0011] Figure 3 is a schematic diagram of the endoluminal stent provided by the present invention in a semi-released state;

[0012] Figure 4 This is a schematic diagram of the local structure of the luminal stent in one embodiment when the restraining unit restrains the corrugated ring;

[0013] Figure 5 yes Figure 1 Schematic diagram of the luminal stent shown when fully deployed;

[0014] Figure 6 is a schematic diagram of another embodiment of a luminal stent when fully deployed;

[0015] Figure 7is a schematic diagram of a luminal stent in yet another embodiment when fully deployed;

[0016] Figure 8 This is a schematic diagram of a case where the first restraining channel and the second restraining channel are formed by a plurality of limiting ring buckles in a luminal stent according to an embodiment;

[0017] Figure 9 This is a schematic structural diagram of a luminal stent (the wavy ring is not shown) in a semi-released state according to an embodiment;

[0018] Figure 10 yes Figure 9 A partial enlarged view of the circled portion of the luminal stent;

[0019] Figure 11 1 is a schematic diagram of another embodiment of a luminal stent (the wavy ring is not shown) in a fully deployed state;

[0020] Figure 12 Schematic diagram of a luminal stent (without the wave-shaped ring shown) in a semi-released state according to another embodiment;

[0021] Figure 13 yes Figure 12 A partial enlarged view of the circled portion of the luminal stent;

[0022] Figure 14 1 is a schematic diagram of another embodiment of a luminal stent (the wavy ring is not shown) in a fully deployed state;

[0023] Figure 15 yes Figure 14 Schematic diagram of the luminal stent shown in a semi-released state;

[0024] Figure 16 yes Figure 14 A schematic diagram of another embodiment of the luminal stent shown is in a semi-released state;

[0025] Figure 17 This is a schematic diagram of another embodiment of a luminal stent, in which a semi-release device is provided with a first limiting rod and a second limiting rod, and the luminal stent (the wavy ring is not shown) is in a semi-released state;

[0026] Figure 18 yes Figure 17 A partial enlarged view of the circled portion of the luminal stent;

[0027] Figure 19 yes Figure 17 A schematic diagram of the luminal stent shown, in which the first limiting rod of the semi-releasing device leaves the locking portion, so that the second limiting rod cooperates with the locking portion;

[0028] Figure 20 yes Figure 17 A schematic diagram of the luminal stent is shown when it is fully deployed;

[0029] Figure 21 This is a schematic diagram of the connection between the locking parts of the paired restraining units and the limiting rods in an embodiment of the endoluminal stent;

[0030] Figure 22 yes Figure 21 A partial enlarged view of the circled portion of the luminal stent;

[0031] Figure 23 yes Figure 21 A schematic diagram of the luminal stent is shown when it is fully deployed. DETAILED DESCRIPTION

[0032] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0033] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used herein in the specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0035] It should be noted that, after release, the end of the luminal stent closest to the heart is defined as the proximal end, and the end farthest from the heart is defined as the distal end.

[0036] In order to solve the problem that when the constraint line 2 is located at one end close to the corrugation ring 1 to constrain the corrugation ring 1, the end of the corrugation ring 1 not constrained by the constraint line 2 is easily tilted outward, which further makes it impossible to adjust the axial and circumferential positions of the stent graft. The prior art proposes a stent graft that concentrates the point of action of the constraint force at the middle position of the corrugated ring, thereby avoiding the warping of the two ends of the corrugated ring. Specifically, as Figure 2 As shown, the stent graft includes a coating 102', a corrugated ring 101' disposed on the coating 102', and a binding harness 20' that can radially bind the corrugated ring 101'. The corrugated ring 101' includes a crest 101a', a trough 101b', and a wave rod 101c' located between the crest 101a' and the trough 101b'. When the binding harness 20' radially binds the stent graft, the point of application of the binding force of the binding harness 20' on the corrugated ring 101' is located on the mid-position coil of the corrugated ring 101', thereby preventing any end of the crest 101a' or the trough 101b' of the corrugated ring 101' from warping outward. It should be explained that the "mid-position coil" mentioned in this article refers to the annular coil formed by connecting the midpoints of each wave rod 101c' in the corrugated ring 101'.

[0037] Different from this, the present application provides a luminal stent, such as Figure 3 and Figure 4 As shown, the endoluminal stent includes a tubular body 10 and a semi-release device 20 connected to the tubular body 10 for radially constraining the tubular body 10. The tubular body 10 includes a corrugated ring 101, and the semi-release device 20 includes multiple restraining wires. The innovative concept of the present invention is to configure the multiple restraining wires so that when the restraining wires extend along the circumference of the tubular body 10 and apply a radial restraining force to the corrugated ring 101, the points of application of the radial restraining force of each restraining wire on the corrugated ring 101 can be connected along the extension direction of the corresponding restraining wires to form a connecting line. In this way, the multiple restraining wires can correspond to multiple connecting lines, with at least two connecting lines spaced apart in the axial direction of the tubular body 10. As a result, the number of force points of the corrugated ring 101 will increase along the axial direction of the corrugated ring 101, and when the corrugated ring 101 is radially constrained by multiple strands of binding wire harnesses, the corrugated ring 101 will be subjected to more balanced force along its axial direction, thereby preventing the end of the corrugated ring 101 from warping outward relative to the other end, and further preventing the warped portion from being anchored to the lumen wall, so that the lumen support has good stability in the semi-released state and can continue to adjust its position, thereby improving the accuracy of the axial and circumferential positioning of the lumen support.

[0038] It should be noted that each of the multiple restraining wires may include one or more restraining wires. The number of restraining wires included in the restraining unit is not limited and may be two or more, for example, three, four, five, or more, as long as at least two of the restraining wires in the restraining unit are spaced axially along the tubular body 10 when the multiple restraining wires apply radial restraining force to the corrugated annular object.

[0039] That is, when the multiple-strand restraint harness applies a radial restraining force to the corrugated ring 101, within the axial interval of the corrugated ring 101, the points of application of the radial restraining force of the multiple-strand restraint harness on the corrugated ring 101 are located on at least two spaced lines. The restraint harness can extend along the circumference of the tubular body 10, or the extension direction of the restraint harness can form a certain angle with the circumference of the tubular body 10, which can be acute or obtuse. That is, the line corresponding to the restraint harness can extend along the circumference of the tubular body 10, or the line can form a certain angle with the circumference of the tubular body 10, which can be acute or obtuse.

[0040] In one embodiment, one of the at least two connecting lines is located on one side of the central coil, and the other of the at least two connecting lines is located on the other side of the central coil, thereby concentrating the restraining force on both sides of the central coil, thereby ensuring force balance on the corrugated ring 101 and preventing the ends of the corrugated ring 101 from tilting. It can also be understood that among the multiple connecting lines corresponding to the multiple binding wire bundles, some connecting lines are located on one side of the central coil and others are located on the other side of the central coil, thereby maintaining force balance on the corrugated ring 101 and preventing the ends of the corrugated ring 101 from tilting, further preventing the tilted portion from being anchored to the lumen wall and preventing the axial and circumferential position of the endoluminal stent from being adjusted.

[0041] Specifically, see Figure 3 One embodiment of the present application provides a luminal stent, comprising a tubular body 10 and a semi-release device 20 connected to the tubular body 10 for radially constraining the tubular body 10 .

[0042] The tubular body 10 includes a corrugated ring 101, which is made of a biocompatible material, such as nickel titanium, stainless steel, etc. In some embodiments, multiple coils of corrugated rings 101 are arranged in sequence along the axial direction of the tubular body 10 from the proximal end to the distal end, preferably in parallel and spaced apart arrangement.

[0043] Combine Figure 4As shown, the wavy ring 101 includes a plurality of crests 101a, a plurality of troughs 101b, and a plurality of connecting rods 101c that connect adjacent crests 101a and troughs 101b. The wavy ring 101 is a closed cylindrical structure. Multiple turns of the wavy ring 101 can have the same or similar wavy shapes. It is understood that this embodiment does not limit the specific structure of the wavy ring 101. The wavy shape of the wavy ring 101 can be set as needed, and the number of waves in each turn of the wavy ring 101 and the height of the waves can also be set as needed.

[0044] The multi-turn corrugated ring 101 is connected to a coating 102 , which is made of a polymer material with good biocompatibility, such as PTFE (Poly tetra fluoroethylene), FEP (Fluorinated ethylene propylen), and PET (Polyethylene terephthalate).

[0045] Continue reading Figure 4 As shown, the corrugated ring 101 further includes a first region A1 and a second region A2, spaced opposite each other along its axial direction and surrounding its circumference. The width D1 of the first region A1 extends axially from the crest 101a toward the trough 101b by 2 / 5 of the wave height. In other words, the two sides b1 and b2 defining the width D1 of the first region A1 respectively surround the corresponding crest 101a of the corrugated ring 101 and a position perpendicularly spaced from the crest 101a by 2 / 5 of the wave height. The width D2 of the second region A2 extends axially from the trough 101b toward the crest 101a by 2 / 5 of the wave height. In other words, the two sides b3 and b4 defining the width D2 of the second region A2 respectively surround the corresponding trough 101b of the corrugated ring 101 and a position perpendicularly spaced from the trough 101b by 2 / 5 of the wave height. It should be noted that the wave height refers to the vertical distance from the wave crest to the wave trough along the axis of the wave-shaped ring 101 .

[0046] Combine Figure 3 and Figure 4 As shown, the semi-release device 20 includes a limiting rod 21 and a plurality of restraining units 22 spaced apart along the axial direction of the tubular body 10. The restraining units 22 correspond one-to-one with the corrugated rings 101 and are used to radially restrain the tubular body 10, so that the restrained portion of the tubular body 10 is uniformly compressed.

[0047] Specifically, the restraining unit 22 includes a plurality of restraining wires, a first restraining channel, and a second restraining channel. The plurality of restraining wires include a first wire 221 and a second wire 222. The radial restraining force exerted by the plurality of restraining wires on the corrugated ring 101 is applied along at least two spaced-apart connecting lines. At least one of the at least two connecting lines is located within a first area A1, and at least another of the at least two connecting lines is located within a second area A2, thereby ensuring force balance.

[0048] Specifically, the first wire bundle 221 and the second wire bundle 222 are respectively passed through the first restraining channel and the second restraining channel. The first restraining channel is located in the first area A1, and the second restraining channel is located in the second area A2, so that the first wire bundle 221 is set in the first area A1, and the second wire bundle 222 is set in the second area A2. The first restraining channel and the second restraining channel are both arranged circumferentially along the tubular body 10, that is, the first restraining channel extends along the circumferential side of the tubular body 10, and accordingly, the second restraining channel extends along the circumferential side of the tubular body 10, so that the first restraining channel is used to have a good limiting effect on the first wire bundle 221 located therein in the axial direction of the tubular body 10, and accordingly, the second restraining channel is used to have a good limiting effect on the second wire bundle 222 located therein in the axial direction of the tubular body 10.

[0049] It should be noted that the first restraining channel and the second restraining channel are extended along the circumference of the tubular body 10, including a continuous extension along the tubular body 10 and an interval extension along the circumference of the tubular body 10. In fact, this is related to the structure of the first restraining channel and the second restraining channel. The first restraining channel will be used as an example for explanation below.

[0050] For example, combined with Figure 4 and Figure 5 As shown, the first restraining channel is composed of a plurality of limiting ring buckles 223 spaced apart along the circumference of the tubular body 10. The limiting ring buckles 223 can be fixed to the connecting rod 101c of the corrugated ring 101 or to the coating 102 on the corrugated ring 101. This is not limited here. As long as the first restraining channel is located in the first area A1 and the second restraining channel is located in the second area A2, the first restraining channel can position the first wire bundle 221 in the first area A1 and the second restraining channel can position the second wire bundle 222 in the second area A2. In this embodiment, the first wire bundle 221 passes through the first restraining channel formed by the limiting ring buckles 223 and is axially constrained relative to the tubular body 10. Because the plurality of limiting ring buckles 223 are spaced apart from each other, the first restraining channel is arranged at intervals along the circumference of the tubular body 10.

[0051] For example, combining Figure 6 As shown, a cover 224 is provided on the outer surface of the covering film 102 , and a first restraining channel and a second restraining channel are formed between the cover 224 and the covering film 102 .

[0052] It should be noted that, in some embodiments, only one of the first confining channel and the second confining channel is formed by the cover 224 and the film 102 , that is, formed between the cover 224 and the film 102 .

[0053] For example, one of the first restraining channel and the second restraining channel is formed by a plurality of limiting ring buckles 223 spaced apart along the circumference of the tubular body 10, and the other is formed between the covering 224 and the coating 102. Figure 7 As shown, the first restraining channel is composed of a plurality of limiting ring buckles 223 spaced apart along the circumference of the tubular body 10 , and the second restraining channel is formed between the covering 224 and the coating 102 .

[0054] The limiting rod 21 can be located outside or inside the tubular body 10, as long as the limiting rod 21 can be used to detachably restrain the restraining unit 22 to the tubular body 10. In other words, the limiting rod 21 can be used to detachably connect the multiple restraining wires of the restraining unit 22 end-to-end, thereby radially restraining the tubular body 10. Of course, in other embodiments, when radially restraining the tubular body 10, the restraining wires do not need to be connected end-to-end, as long as the restraining wires can restrain at least a portion of the tubular body 10. For example, the restraining wires can radially restrain only half of the tubular body 10 along the circumferential direction.

[0055] It should be noted that since the first and second restraining channels can respectively restrain the first and second wire bundles 221, 222 within the first and second regions A1, A2, thereby preventing the crests 101a and troughs 101b of the wave-shaped ring 101 from tilting, arranging the first and second wire bundles 221, 222 within the first and second restraining channels provides greater flexibility. For example, in some embodiments, the first wire bundle 221 can move axially along the tubular body 10 within the first restraining channel. This structural arrangement prevents the first wire bundle 221 from being too tightly contacted with the first restraining channel, thereby ensuring that when the tubular body 10 is released, as the tubular body 10 expands, the first wire bundle 221 can flexibly move along the first restraining channel, thereby allowing the tubular body 10 to expand stably.

[0056] Accordingly, in some embodiments, the second wire bundle 222 can move in the axial direction of the tubular body 10 within the second restraining channel, thereby improving the flexibility of the second wire bundle 222 in moving along the second restraining channel.

[0057] Combine Figures 5 to 7 As shown, one end of the first wire harness 221 and the second wire harness 222 is fixedly connected to the tubular body 10 , and the other end forms a locking portion 220 a , which is detachably connected to the limiting rod 21 .

[0058] It should be noted that the locking portion 220a may be formed by connecting the first wire harness 221 and the second wire harness 222 to each other, or may be formed by combining corresponding locking structures.

[0059] For example, combined with Figure 6 As shown, the locking portion 220a includes a first loop 221a and a second loop 222a, the first loop 221a is connected to the first wire harness 221, the second loop 222a is connected to the second wire harness 222, and the limiting rod 21 can be movably passed through the first loop 221a and the second loop 222a to realize the detachable connection between the limiting rod 21 and the locking portion 220a. When the limiting rod 21 is connected to the locking portion 220a, the limiting rod 21 is positioned relative to the circumference of the tubular body 10, causing the first and second wire bundles 221 and 222 to constrain the tubular body 10 circumferentially, thereby compressing the tubular body 10 circumferentially and controlling it in a semi-released state by the semi-release device 20. Thus, after the stent 100 is released from the delivery sheath, the semi-released state of the stent 100 does not adhere to the vessel wall under the constraint of the semi-release device 20. However, the operator can still adjust the axial and circumferential position of the stent 100. Once the position is accurate, the constraint of the semi-release device 20 is released, allowing the stent 100 to deploy and adhere to the vessel wall. Furthermore, along the axial direction of the corrugated ring 101, the points of application of the first and second wire bundles 221 and 222 on the corrugated ring are located on at least two spaced lines, thereby preventing warping of the ends of the corrugated ring 101 due to uneven force. In addition, the first binding channel and the second binding channel are used to confine the first wire harness 221 to the first area A1, and the second wire harness 222 to the second area A2, so as to avoid the aggregation of multiple strands of binding wire harnesses in the center coil. If the multiple strands of binding wire harnesses are aggregated in the center coil, the multiple strands of binding wires will be offset toward one end of the corrugated ring 101 under the action of external force (such as the axial direction of the conveyor on the multiple strands of binding wires) and will be tilted again.

[0060] It is understandable that one of the first ring 221a and the second ring 222a can be eliminated, or the two can be combined into one to form an integral ring structure. At this time, the locking portion 220a is an annular member, and the first wire harness 221 and the second wire harness 222 are both connected to the annular member. The limiting rod 21 can be movably passed through the annular member to realize the detachable connection between the limiting rod 21 and the locking portion 220a.

[0061] Combine Figure 7 As shown, in other embodiments, the locking portion 220a may also be formed by connecting the first wire harness 221 and the second wire harness 222 to each other.

[0062] The first wire harness 221 and the second wire harness 222 are formed by folding the binding wire in half, and the folded position of the binding wire forms a locking portion 220 a . The limiting rod 21 is disposed between the first wire harness 221 and the second wire harness 222 .

[0063] It is understood that, in addition to being formed by folding the binding wire in half, the locking portion 220a can also be formed by joining the first wire bundle 221 and the second wire bundle 222. Specifically, one end of the first wire bundle 221 and the second wire bundle 222 are connected to the tubular body 10, and the other ends are connected to each other, so that the locking portion 220a is detachably connected to the limiting rod 21 at the connection position.

[0064] When the locking portion 220a is connected to the limiting rod 21, the binding unit 22 radially constrains the tubular body 10. At this time, the first binding channel and the second binding channel constrain the first wire bundle 221 and the second wire bundle 222 to be spaced apart along the axial direction of the tubular body 10 between the crest 101a and the trough 101b. Figure 8 As shown, taking the example of the first binding channel and the second binding channel respectively having a plurality of limiting ring buckles 223 arranged at intervals along the circumference of the tubular main body 10, the first wire harness 221 and the second wire harness 222 are respectively passed through the limiting ring buckles 223 constituting the first binding channel and the second binding channel. When the locking portion 220a is connected to the limiting rod 21, the first wire harness 221 and the second wire harness 222 radially constrain the tubular main body 10. At this time, the first wire harness 221 and the second wire harness 222 are spaced between the crest 101a and the trough 101b by the corresponding limiting ring buckles 223. In this way, the first wire harness 221 and the second wire harness 222 respectively uniformly constrain the side of the crest 101a and the side of the trough 101b of the corrugated ring 101, thereby improving the stability of the compression state of the corrugated ring 101, thereby making the tubular main body 10 stably in a uniformly compressed state.

[0065] Recombination Figure 3 and Figure 4 As shown, when the locking portion 220a is connected to the limiting rod 21 so that the restraining unit 22 radially constrains the tubular body 10, the vertical distance between the first wire bundle 221 and the second wire bundle 222 is L, the vertical distance from any crest 101a corresponding to the first restraining channel to the first wire bundle 221 is L1, and the vertical distance from any trough 101b corresponding to the second restraining channel to the second wire bundle 222 is L2, wherein L≥L1+L2, and / or L1=L2.

[0066] By utilizing this structural setting, the portion of the corrugated ring 101 close to the crest 101a and the portion close to the trough 101b are uniformly compressed by the first wire bundle 221 and the second wire bundle 222 respectively, and since the first wire bundle 221 and the second wire bundle 222 are respectively limited to the tubular body 10 at intervals from each other in the first restraining channel and the second restraining channel, the corrugated ring 101 can be stably in a compressed state. In this way, when the luminal stent is controlled in a semi-released state by the semi-release device 20, the overall contraction is uniform, and the luminal stent 100 does not fit the blood vessel wall. The operator can adjust the axial and circumferential position of the luminal stent 100, and after accurate positioning, release the constraint of the semi-release device 20 to allow the luminal stent 100 to unfold and adhere to the wall.

[0067] Combine Figure 8 and Figure 10 As shown, one end of the first wire bundle 221 and one end of the second wire bundle 222 are respectively connected to two fixed points 220b on the tubular body 10, and the line connecting the two fixed points 220b is parallel to the axial direction of the tubular body 10. When the locking portion 220a is connected to the limiting rod 21, the limiting rod 21 limits the locking portion 220a to the two fixed points 220b along the circumference of the tubular body 10, and along the axial direction of the limiting rod 21, the locking portion 220a is limited between the two fixed points 220b, that is, the two fixed points limit the end of the locking portion 220a along the axial direction of the tubular body 10, so that the locking portion 220a remains stable along the axial direction of the tubular body 10, so that the binding unit 22 stably compresses the position of the tubular body 10 corresponding to the corrugated ring 101, which is beneficial to improve the stability of the luminal stent in the semi-released state.

[0068] Combine Figure 11 As shown, in other embodiments, one end of the first wire bundle 221 and one end of the second wire bundle 222 are connected to the same fixing point 222t on the tubular body 10.

[0069] Combine Figure 12 and Figure 13 As shown, the limiting rod 21 can still be constrained at the fixed point 222t by the first wire harness 221 and the second wire harness 222 and cannot move relative to the tubular body 10 in the direction opposite to the direction in which the first wire harness 221 is wound around the tubular body 10. Then, when the limiting rod 21 cooperates with the locking portion 220a, the first wire harness 221 and the second wire harness 222 both maintain radial constraint on the tubular body 10 under the constraint of the limiting rod 21, so that the tubular body 10 is evenly compressed and in a semi-released state, which facilitates subsequent adjustment of the position of the endoluminal stent.

[0070] Combine Figure 14As shown, the binding unit 22 includes a limiting buckle 103 fixedly connected to the tubular body 10. These limiting buckles 103 can be used to position the limiting rod 21 relative to the tubular body 10 in the circumferential direction, and can also be used to limit the first and second wire harnesses 221 and 222 in the axial direction of the tubular body 10.

[0071] Combine Figure 15 As shown, in some embodiments, one end of the first and second wire harnesses 221, 222, forming the locking portion 220a, respectively, passes through the first and second restraining channels and is movably mounted on the retaining buckle 103. In this embodiment, the retaining buckle 103 ensures that the unrestricted portions of the first and second wire harnesses 221, 222, respectively, after passing through the first and second restraining channels, maintain a stable axial position relative to the tubular body 10. The number of retaining buckles 103 can be configured based on actual needs and can be one, two, or more, without limitation.

[0072] It should be noted that, in some embodiments, the limiting rod 21 can be movably installed in the limiting buckle 103, and the limiting rod 21 cooperates with the locking portion 220a, so that the first wire harness 221 and the second wire harness 222 radially constrain the tubular body 10.

[0073] Continue reading Figure 15 and Figure 16 As shown, when multiple limiting buckles 103 are spaced apart along the circumference of the tubular body 10, the limiting rod 21 cooperates with the limiting buckles 103 at different positions and can be constrained at different positions on the circumference of the tubular body 10. In this way, the restraining area of the tubular body 10 by the restraining unit 22 can be adjusted. Specifically, the restraining unit 22 can constrain at every position around the circumference of the tubular body 10, so that the tubular body 10 is uniformly compressed at all circumferential positions, or it can constrain at a local position on the circumference of the tubular body 10, so that the circumference of the tubular body 10 has a constrained portion and an unconstrained portion. In other words, when the tubular body 10 is in a semi-released state, the constrained portion will be uniformly compressed circumferentially under the restraint of the restraining unit 22, while the unconstrained portion will be in a naturally expanded state due to the lack of restraint. In this way, components with high positioning requirements, such as branches, branch windows, and keels, can be placed in the unconstrained portion as needed, so that the branches, branch windows, and keels on the unconstrained portion can be accurately positioned when the tubular body 10 is in the semi-released state.

[0074] In some embodiments, the semi-releasing device 20 includes at least two limiting rods 21, and the at least two limiting rods 21 are limited to the tubular body 10 at intervals along the circumference of the tubular body 10. Figure 17The semi-release device 20 shown includes two limiting rods 21 as an example. For the convenience of description, the two limiting rods 21 are respectively referred to as "first limiting rod 21'" and "second limiting rod 21". The first limiting rod 21' and the second limiting rod 21" are respectively limited to the tubular main body 10 at intervals along the circumference of the tubular main body 10. The first limiting rod 21' and the second limiting rod 21" are both arranged between the first wire harness 221 and the second wire harness 222. When the first limiting rod 21' near the locking portion 220a is released, the tubular main body 10 will be further released and expanded until the locking portion 220a cooperates with the second limiting rod 21". At this time, the tubular main body 10 is still in a state of being partially circumferentially constrained. After the first limiting rod 21' is separated from the locking portion 220a, a part of the structure of the tubular main body 10 loses the circumferential constraint of the constraining unit 22 and unfolds, so that the unfolded part has good stability. Figure 17 As shown, the branch window 105 can be set in this part, and other components with high positioning requirements such as branches or keels can also be set in this part, that is, the part between the first limiting rod 21' and the second limiting rod 21".

[0075] Combine Figure 19 As shown, after the first limiting rod 21 ′ is separated from the locking portion 220 a, the second limiting rod 21 ″ can continue to keep the restraining unit 22 in a state of partially circumferentially restraining the tubular body 10 , so as to subsequently adjust the position of the tubular body 10 and position the branch window 105 .

[0076] Combine Figure 20 As shown, after the second limiting rod 21" is separated from the locking portion 220a, the tubular body 10 will be fully deployed and released. With this structural setting, the semi-release device 20 can perform a controllable graded release of the tubular body 10, so that the important positioning area of the first step of release and full deployment can be more accurately positioned, and then the second stage of release and adherence to the wall can be performed. This graded release is particularly beneficial for the precise positioning of the luminal stent with branches or branch fenestrations.

[0077] It should be noted that, in an embodiment in which at least two limiting rods 21 are spaced apart from each other along the circumference of the tubular body 10 and limited in the tubular body 10, the circumferential limiting method of the limiting rods 21 relative to the tubular body 10 may be to utilize a positioning structure, or to utilize the aforementioned binding unit 22 itself to limit the limiting rods 21 circumferentially relative to the tubular body 10 at the connection position between the first wire harness 221 and the second wire harness 222 and the tubular body 10.

[0078] For example, combined with Figure 17 and Figure 18 As shown, a lock buckle 104 is fixedly connected to the tubular body 10 , and the lock buckle 104 is used for allowing any one of the at least two limiting rods 21 to pass through.

[0079] A plurality of lock buckles 104 are fixedly connected to the tubular body 10 . The number of the lock buckles 104 is equal to the number of the limiting rods 21 . The plurality of lock buckles 104 respectively and correspondingly limit the limiting rods 21 in the tubular body 10 along the circumference of the tubular body 10 .

[0080] In some embodiments, a plurality of lock buckles 104 are fixedly connected to the tubular body 10, and the number of lock buckles 104 is one less than the number of limiting rods 21. At least one of the two limiting rods 21 is constrained by the constraining unit 22 at the connection position between the constraining unit 22 and the tubular body 10 in a direction opposite to the extension direction of the constraining unit 22 along the circumferential side of the tubular body 10. The plurality of lock buckles 104 correspondingly limit the other limiting rods 21 to the tubular body 10 along the circumference of the tubular body 10.

[0081] For example, combined with Figure 17 As shown, the tubular body 10 is provided with a lock buckle 104. Accordingly, there are two limiting rods 21, one of which is bound by the binding unit 22 at the connection position between the first wire harness 221 and the second wire harness 222 of the binding unit 22 and the tubular body 10 in the opposite direction to the extension direction of the binding unit 22 along the circumferential side of the tubular body 10. The lock buckle 104 correspondingly limits the other limiting rod 21 to the tubular body 10 along the circumference of the tubular body 10.

[0082] Combine Figures 21 to 23 As shown, the semi-release device 20 includes at least one group of paired binding units 22, and along the circumference of the tubular body 10, the paired binding units 22 extend in opposite directions along the circumference of the tubular body 10. That is, after one end of the first wire harness 221 and the second wire harness 222 of the paired binding units 22 is fixedly connected to the tubular body 10, the other ends extend in opposite directions along the circumference of the tubular body 10 and form a locking portion 220a.

[0083] In this embodiment, the paired restraining units 22 are configured so that when the limiting rods 21 are separated from the locking portions 220a of the paired restraining units 22, the paired restraining units 22 can simultaneously release the restraints on a localized area of the tubular body 10, allowing the stent to deploy more quickly and adhere to the wall. Furthermore, because the fixed ends 22a of the paired restraining units 22 are located on either side of the limiting buckles 103, when the paired restraining units 22 release their restraints on the tubular body 10, the restrained portions of the stent deploy circumferentially in opposite directions, thereby offsetting the circumferential force generated during the stent deployment process. This improves the stability of the stent deployment and allows for more precise positioning.

[0084] The paired restraining units 22 are of equal length. More precisely, the first wire strands 221 of each restraining unit 22 are of equal length, and the second wire strands 222 of each restraining unit 22 are of equal length. Therefore, when the limiting rods 21 separate from the locking portions 220a of the paired restraining units 22, the paired restraining units 22 simultaneously release their radial constraints on the tubular body 10. The circumferential forces exerted on the tubular body 10 in two opposite directions are substantially equal in magnitude and thus effectively offset, resulting in more stable stent deployment and more precise positioning.

[0085] Combine Figure 21 As shown, the first wire bundles 221 of the paired restraining units 22 are connected to the tubular body 10 at the same fixed point 220d on the tubular body 10, and the second wire bundles 222 of the paired restraining units 22 are connected to the same fixed point 220e on the tubular body 10. With this structural arrangement, the arrangement of the first restraining channels and the second restraining channels in the paired restraining units 22 is relatively simple, and no major structural changes are required.

[0086] It is understood that the present application does not limit the number of groups of the binding units 22 arranged in pairs. Figure 21 As shown, the semi-release device 20 includes three groups of paired restraining units 22. In other embodiments, the semi-release device 20 may also include two or more groups of restraining units 22. Alternatively, in addition to the paired restraining units 22, the semi-release device 20 may also include unpaired restraining units 22, so that some restraining units 22 are arranged in pairs and others are arranged unpaired, thereby increasing the flexibility of the axial restraint process of the restraining area 111.

[0087] The limiting rod 21 can be made of a metal guide wire with good elastic memory and low surface roughness, such as a nickel-titanium wire. This wire meets the required physical properties and has good biocompatibility with the human body. The diameter of the limiting rod 21 can be selected to be 0.2 mm to 0.6 mm, ensuring an appropriate diameter. Avoid excessively large diameters of the limiting rod 21, which would increase the overall profile (i.e., the pass-through area) of the luminal stent. Excessively large diameters of the limiting rod 21 can result in insufficient support force, affecting the restraining effect on the locking portion 220a.

[0088] In some embodiments, the surface roughness of the limiting rod 21 is less than or equal to 0.2 μm, so that the limiting rod 21 can be smoothly withdrawn from the locking portion 220 a , thereby releasing the constraint on the locking portion 220 a .

[0089] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0090] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A luminal stent, comprising a tubular body and a semi-release device connected to the tubular body, characterized in that: The tubular body includes a wave-shaped ring, and the semi-releasing device includes a restraining unit, which includes a plurality of restraining wire bundles. When the restraining wire bundles extend along the circumference of the tubular body and apply radial restraining force to the wave-shaped ring, within the axial interval where the wave-shaped ring is located, the points of application of the radial restraining force of each restraining wire bundle on the wave-shaped ring can be connected along the extension direction of the corresponding restraining wire bundles to form a connecting line, so as to form a plurality of connecting lines corresponding to the plurality of restraining wire bundles, and at least two of the connecting lines are spaced apart in the axial direction of the tubular body; the restraining unit includes a first restraining channel and a second restraining channel. The restraint channel, the multiple restraint wire bundles include a first wire bundle and a second wire bundle, the first wire bundle and the second wire bundle are respectively passed through the first restraint channel and the second restraint channel, the luminal stent includes a plurality of the wavy rings and a coating connected to the plurality of the wavy rings, the outer surface of the coating is provided with a covering, the first restraint channel and / or the second restraint channel is formed between the covering and the coating, or one of the first restraint channel and the second restraint channel is formed between the covering and the coating, and the other is composed of a plurality of limiting ring buckles arranged at intervals along the circumference of the tubular body.

2. The endoluminal stent according to claim 1, characterized in that: The waveform ring can form a median coil, at least one of the two connecting lines is located on one side of the median coil, and the other of at least two of the connecting lines is located on the other side of the median coil. The median coil is a ring coil formed by connecting the midpoints of each wave rod in the waveform ring.

3. The endoluminal stent according to claim 1 or 2, characterized in that: The waveform ring includes multiple peaks, multiple troughs and multiple connecting rods respectively connecting adjacent peaks and troughs. The waveform ring also includes a first area and a second area that are spaced apart from each other along the axial direction and surround the circumference. The width of the first area is 2 / 5 times the wave height extending axially from the peak to the trough. The width of the second area is 2 / 5 times the wave height extending axially from the trough to the peak. At least one of the two connecting lines is located in the first area, and the other of the at least two connecting lines is located in the second area.

4. The endoluminal stent according to claim 3, characterized in that: The semi-release device also includes a limiting rod, one end of the first wire harness and the second wire harness is fixedly connected to the tubular body, and the other end is formed with a locking portion, and the locking portion is detachably connected to the limiting rod. When the locking portion is connected to the limiting rod, the restraining unit radially constrains the tubular body, and the first restraining channel and the second restraining channel are both arranged along the circumference of the tubular body, and limit the first wire harness and the second wire harness to be spaced apart along the axial direction of the tubular body between the wave crest and the wave trough.

5. The endoluminal stent according to claim 4, characterized in that: The first confinement channel is located in the first area, and the second confinement channel is located in the second area.

6. The endoluminal stent according to claim 4, characterized in that: When the locking portion is connected to the limiting rod so that the restraining unit radially constrains the tubular body, the vertical distance between the first wire bundle and the second wire bundle is L, the vertical distance from any one of the crests corresponding to the first restraining channel to the first wire bundle is L1, and the vertical distance from any one of the troughs corresponding to the second restraining channel to the second wire bundle is L2, wherein L≥L1+L2, and / or L1=L2.

7. The endoluminal stent according to claim 4, characterized in that: The first wire harness and the second wire harness are formed by folding a binding line in half, the folded position of the binding line forms the locking portion, and the limiting rod is provided between the first wire harness and the second wire harness; Alternatively, the locking portion is formed by joining the other end of the first wire harness and the other end of the second wire harness, and the limiting rod is provided between the first wire harness and the second wire harness.

8. The endoluminal stent according to claim 7, characterized in that: The semi-releasing device includes at least two limiting rods, and the at least two limiting rods are limited to the tubular body at intervals along the circumference of the tubular body.

9. The endoluminal stent according to claim 8, characterized in that: A lock buckle is fixedly connected to the tubular body, and the lock buckle is used for allowing any one of the at least two limiting rods to pass through; Alternatively, the tubular body is fixedly connected to a plurality of lock buckles, the number of the lock buckles being equal to the number of the limiting rods, and the plurality of lock buckles respectively and correspondingly limit the limiting rods to be positioned in the tubular body along the circumference of the tubular body; Alternatively, a locking buckle is fixedly connected to the tubular body, and the number of the locking buckles is one less than the number of the limiting rods. One of the at least two limiting rods is constrained by the constraining unit at the connection position between the constraining unit and the tubular body in a direction opposite to the extension direction of the constraining unit along the circumferential side of the tubular body. The multiple locking buckles correspondingly limit the other limiting rods to the tubular body along the circumference of the tubular body.

10. The endoluminal stent according to claim 4, characterized in that: The binding unit includes a limiting buckle fixedly connected to the tubular body, and the limiting buckle is used for allowing the limiting rod to be movably passed through; and / or, the binding unit includes a limiting buckle fixedly connected to the tubular body, and one end of the first wire harness and the second wire harness that form the locking part respectively passes through the first binding channel and the second binding channel, and can be movably passed through the limiting buckle.

11. The endoluminal stent according to claim 4, characterized in that: The first wire bundle is movable in the first binding channel along the axial direction of the tubular body, and / or the second wire bundle is movable in the second binding channel along the axial direction of the tubular body.

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