WO2023025045A1

WO2023025045A1 - Luminal stent

Info

Publication number: WO2023025045A1
Application number: PCT/CN2022/113477
Authority: WO
Inventors: 唐春炜
Original assignee: 先健科技(深圳)有限公司
Priority date: 2021-08-24
Filing date: 2022-08-19
Publication date: 2023-03-02
Also published as: CN115869105A

Abstract

A luminal stent, comprising a tubular main body (10) and a semi-release device (20), which is connected to the tubular body (10). The semi-release device (20) comprises a binding line (22), which is arranged on the tubular body (10), and at least two limiting rods (21), wherein the binding line (22) is provided with locking portions (22a); at least two limiting rods (21) are limited on the tubular main body (10) at an interval in the circumferential direction of the tubular body (10) and are used for being detachably connected to the locking portions (22a); and when the limiting rods (21) are connected to the locking portions (22a), the locking portions (22a) are limited on the limiting rods (21) in the radial direction of the limiting rods (21) and enable the binding line (22) to bind the tubular main body (10) in the circumferential direction.

Description

Endoluminal stent

technical field

The present application relates to the technical field of interventional medical devices, in particular to a lumen stent.

Background technique

In the past ten years, endovascular exclusion of aortic stent grafts has been widely used in thoracic and abdominal aortic aneurysms and arterial dissections. treatment method. During the operation, under X-ray fluoroscopy monitoring, the covered stent is sent to the lesion through the corresponding delivery system. The covered stent isolates the blood flow from the lesion, eliminates the influence of blood pressure on the lesion, and achieves the purpose of healing.

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 axial and circumferential directions of the stent-graft are positioned using the development marks. However, when the stent-graft is compressed in the delivery sheath, it has compression folds in the circumferential direction and is in an elongated state in the axial direction. If it is positioned by the development mark at this time, there will be large circumferential and axial deviations. Therefore, in the prior art, the stent-graft is constrained radially by binding the wire harness, so that the stent-graft is in a half-release state. When the stent-graft is in a semi-released state, its outer diameter is larger than that when it is loaded in the conveyor, and is smaller than the outer diameter of the stent-graft when it is fully released and anchored in the lumen of the human body. Compared with positioning the position of the stent-graft through the development structure when the stent-graft is loaded in the conveyor, the outer diameter of the stent-graft in the semi-released state is closer to the outer diameter of the fully released state, and positioning through the development structure will also more precise.

However, during the axial and circumferential positioning of the luminal stent, the controllability is poor, the positioning accuracy encounters a bottleneck, and the stability of the luminal stent deployment process needs to be improved urgently.

Contents of the invention

Based on this, it is necessary to provide a lumen stent.

The present application provides a lumen stent, which includes a tubular body and a semi-release device connected to the tubular body, the semi-release device includes a binding wire and at least two limit rods arranged on the tubular body, the binding The wire has a locking portion, and the at least two limiting rods are limited to the tubular body at intervals along the circumferential direction of the tubular body, and are used for detachable connection with the locking portion, wherein, when the limiting rods When connected with the locking part, the locking part is limited to the limiting rod along the radial direction of the limiting rod and makes the binding wire constrain the tubular main body in a circumferential direction.

Description of drawings

The present invention will be further described below in conjunction with accompanying drawing and embodiment, in the accompanying drawing:

Fig. 1 is a schematic structural view of a lumen stent of an embodiment;

Fig. 2 is a schematic diagram of the structure of the endoluminal stent shown in Fig. 1 , when the cooperation between the first limiting rod and the locking part is released to partially release the endoluminal stent;

3 is a schematic structural view of a lumen stent in another embodiment;

Fig. 4 is an enlarged schematic view of the local structure at the circle of the lumen stent shown in Fig. 3;

Fig. 5 is a schematic structural view of another embodiment of a luminal stent;

Fig. 6 is a schematic structural view of yet another embodiment of a luminal stent;

Fig. 7 is a schematic structural view of a lumen stent in another embodiment;

Fig. 8 is a schematic structural view of a lumen stent in another embodiment;

Fig. 9 is a schematic structural view of another embodiment of a luminal stent;

Fig. 10 is a schematic structural view of another embodiment of a luminal stent;

Fig. 11 is a schematic structural view of a lumen stent in another embodiment;

Fig. 12 is a schematic structural view of a lumen stent in another embodiment;

Fig. 13 is a schematic diagram of the partial structure of the binding channel corresponding to the confinement of the wave-shaped ring in the endoluminal stent of an embodiment.

Detailed ways

In order to make the above objects, features and advantages of the present invention more comprehensible, specific implementations of the present invention will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present invention, so the present invention is not limited by the specific implementations disclosed below.

It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and similar expressions are used herein for purposes of illustration only and are not intended to represent the only embodiments.

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

It should be noted that the end of the endoluminal stent that is closer to the heart after release is defined as the proximal end, and the end farther from the heart is defined as the distal end.

Referring to FIG. 1 , one embodiment of the present application provides a lumen stent, which includes a tubular body 10 and a semi-releasing device 20 connected to the tubular body 10 for constraining the tubular body 10 radially.

The half release device 20 includes at least two limiting rods 21 and a binding wire 22 arranged on the tubular body 10 . Wherein, the binding wire 22 has a locking portion 22a, and at least two limiting rods 21 are limited to the tubular body 10 along the circumferential direction of the tubular body 10 at intervals. On the one hand, they are spaced apart from each other, and at the same time, each limiting rod 21 is limited to the tubular main body 10, and then cannot move relative to the tubular main body 10 along the circumferential direction of the tubular main body 10, so that the limiting rods 21 are connected to the locking portion 22a At this time, the tubular main body 10 can be constrained circumferentially by the binding wire 22, specifically, when the limiting rod 21 is connected to the locking portion 22a, the locking portion 22a is limited to the limiting rod 21 along the radial direction of the limiting rod 21 and The binding wire 22 is made to bind the tubular body 10 circumferentially. It should be noted that the limiting rod 21 and the locking portion 22a are detachably connected, so that when the limiting rod 21 is separated from the locking portion 22a, the binding of the limiting rod 21 to the binding wire by the locking portion 22a can be released. 22 exerts traction on the binding force on the tubular body 10, so that part of the tubular body 10 is released. And because the half release device 20 includes at least two limit rods 21, when releasing different limit rods 21 successively, the restrained position of the tubular body 10 can be released step by step, so as to improve the controllability of the release operation. performance and release positioning accuracy. Compared with the prior art, when the restrained position of the tubular body 10 is released step by step, one of the at least two limit rods 21 can be released first, thereby releasing the restraint of a part of the tubular body 10 by the restraining wire 22 , so that the size of the tubular body 10 is closer to the size anchored in the blood vessel, so that the positioning of the tubular body is more precise.

The binding wire 22 is connected with the tubular main body 10, and folded in half to form a first wire bundle 221 and a second wire bundle 222, the folding position of the binding wire 22 forms a locking portion 22a, and at least two limit rods 21 are passed through the first wire bundle 221 and the second wire harness 222.

Taking the half-release device 20 shown in FIG. 1 as an example including three limit rods 21, for the convenience of description, the three limit rods 21 are respectively referred to as "the first limit rod 21'" and "the second limit rod 21'". The rod 21"" and the "third limiting rod 21"'", the first limiting rod 21', the second limiting rod 21" and the third limiting rod 21"' are spaced apart from each other along the circumferential direction of the tubular body 10 The ground is limited to the tubular body 10 . The first limit rod 21', the second limit rod 21" and the third limit rod 21"' are all passed between the first strand bundle 221 and the second strand bundle 222, so as to release the first strand close to the locking part 22a. When a stop bar 21', the part of the tubular main body 10 loses the restraint of the binding line 22 and expands, that is, the part of the tubular main body 10 is released until the locking part 22a is matched with the second stop bar 21" (see Fig. 2 shown), at this time, the binding wire 22 is kept in a relaxed state by the tubular body 10 under the constraint of the second limit rod 21", and at the same time, the tubular body 10 no longer continues to expand under the constraint of the binding line 22, that is, the tubular body 10 is still in a partially circumscribed state. After the first limiting rod 21 ′ is separated from the locking portion 22a, a part of the tubular body 10 loses the circumferential restraint of the binding wire 22 and unfolds, so that the unfolded part has good stability. Correspondingly, when the third limiting rod 21"' matched with the locking part 22a is released, the tubular body 10 will expand to make the locking part 22a cooperate with the third limiting rod 21"'. At this time, the binding wire 22 Under the constraint of the third limit rod 21"', the tubular body 10 is kept in a relaxed state. At the same time, the tubular body 10 no longer continues to expand under the constraint of the binding line 22, that is, the tubular body 10 is still partially bound in the circumferential direction. status.

In the above-mentioned embodiment, by gradually releasing the limit rods 2122 (such as the first limit rod 21', the second limit rod 21" and the third limit rod 21"') that cooperate with the locking part 22a, the After the first limiting rod 21 ′, the second limiting rod 21 ″ and the third limiting rod 21 ″’ cooperate with the locking portion 22 a, the tubular body 10 will be fully unfolded and released. The endoluminal stent of the present invention can meet the requirement of step-by-step release of the tubular body 10, so that the controllability of the release operation is good, and the positioning accuracy can be improved when the tubular body 10 is moved to the position to be implanted.

In addition, in some embodiments, as shown in FIG. 3 , the branch window 105 is provided with a part between the first limit rod 21 ′ and the second limit rod 21 ″. Since this part can pass through the first limit rod 21 ′ The cooperation with the locking part 22a is released, that is, it is no longer bound by the binding wire 22 and is in a relaxed state, which has good stability. To be exact, after the first limiting rod 21' is separated from the locking part 22a, the second The two limit rods 21" can continue to keep the binding wire 22 in the state of partially circumferentially restraining the tubular body 10, so as to adjust the position of the tubular body 10 and position the branch window 105, thereby improving the positioning accuracy of the branch window 105 .

It should be noted that, in other embodiments, the components that need to be positioned are not limited to the branch window 105, and may also be other components that require high positioning, such as branches or keels, and these components are provided with the tubular body 10 corresponding to the two limit rods 21, you can improve the accuracy of the release position through the aforementioned step-by-step release method.

In the embodiment where at least two limiting rods 21 are spaced apart from each other along the circumferential direction of the tubular body 10 and are limited to the tubular body 10 , for the circumferential limiting of the limiting rods 21 relative to the tubular body 10 , a positioning structure may be used, It is also possible to use the above-mentioned binding wire 22 itself to restrict the limiting rod 21 relative to the tubular body 10 at the connection position of the first strand bundle 221 and the second strand bundle 222 with the tubular body 10 .

For example, as shown in FIG. 3 and FIG. 4 , a locking buckle 104 is fixedly connected to the tubular body 10 , and the locking buckle 104 is used for allowing any one of at least two limiting rods 21 to pass through.

The tubular body 10 is fixedly connected with a plurality of locks 104, the number of the locks 104 is equal to the number of the limit rods 21, and the plurality of locks 104 correspondingly limit the limit rods 21 to the tubular body 10 along the circumferential direction of the tubular body 10. Subject 10.

In some embodiments, a plurality of locking buckles 104 are fixedly connected to the tubular body 10 , and at least two limiting rods 21 are respectively movably threaded through the plurality of locking buckles 104 along their own axial directions.

In some other embodiments, one of the at least two limiting rods 21 is bound by the binding line 22 between the binding line 22 and the At the connection position of the tubular body 10 , a plurality of locking buckles 104 correspondingly limit the other limiting rods 21 to the tubular body 10 along the circumferential direction of the tubular body 10 .

Taking the lumen stent shown in Figure 3 and Figure 4 as an example, the number of limit rods 21 is two, which are respectively the first limit rod 21' and the second limit rod 21", and the first limit rod 21' In the direction opposite to the extension direction of the tubular main body 10 along the peripheral side of the tubular main body 10 with the binding line 22 , the connection position of the first strand bundle 221 and the second strand bundle 222 bound by the binding wire 22 to the tubular main body 10 , the locking buckle 104 correspondingly constrains the second limiting rod 21 ″ on the tubular main body 10 along the circumferential direction of the tubular main body 10 .

5 and 6, the binding wire 22 has a fixed part 22b and at least two locking parts 22a, the fixed part 22b is fixedly connected with the tubular main body 10, and at least two limit rods 21 are correspondingly installed in at least two locking part 22a, so that after releasing the cooperation between the corresponding stop rod 21 and the lock part 22a, the binding wire 22 correspondingly releases the local restraint on the tubular main body 10, so that the stop rods 21 at different positions are successively pulled away, which can realize The effect of the stepwise release of the tubular body 10 .

It should be noted that, in the embodiment where the binding wire 22 has at least two locking portions 22a, these locking portions 22a may be located on the same side or different sides relative to the fixing portion 22b. For example, taking the binding wire 22 including two locking portions 22a as an example, as shown in FIG. They are located on different sides of the fixing portion 22b at intervals from each other.

In some embodiments, as shown in FIG. 7 , the binding wire 22 has a fixed portion 22b and a wire loop 22c, the fixed portion 22b is fixedly connected to the tubular body 10, and the end position of the wire loop 22c away from the fixed portion 22b forms a locking portion 22a Two or more limit rods 21 are passed through the wire loop 22c, so that after the limit rod 21 matched with the locking part 22a is pulled out, the tubular main body 10 expands so that the lock part 22a of the wire ring 22c and the Adjacent limit rods 21 are matched, and so on, and the limit rods 21 matched with the locking portion 22a are sequentially pulled out, so that the tubular body 10 can be released step by step, thereby improving the controllability of the release operation and the release accuracy. sex.

Further, as shown in FIG. 8 and FIG. 9, the binding wire 22 has at least 2 wire loops 22c, and at least 2 wire loops 22c are located at different sides of the fixing part 22b (see FIG. 8 ) or on the same side ( See Figure 9).

As shown in FIG. 10 , the tubular body 10 is provided with a binding channel 24 , the central angle corresponding to the binding channel 24 is less than 360°, and the position of the binding channel 24 corresponding to the limit rod 21 is formed with an opening 24 a , and the opening 24 a is connected to the inside of the binding channel 24 . The cavities are connected, the restraint wire 22 passes through the restraint passage 24, and the locking portion 22a is used to connect with the corresponding limit rod 21 at the opening 24a.

It should be noted that the structure of the binding channel 24 has many possibilities. For example, as shown in FIG. 10 and FIG. , the binding channel 24 is formed between the cover 103 and the covering film 102; or, as shown in FIGS. A buckle 223 is formed, and the binding wire 22 passes through the buckle 223 of the limiting ring.

As shown in FIG. 12 and FIG. 13 , the tubular body 10 includes a wave-shaped ring 101 , and the wave-shaped ring 101 is made of materials with good biocompatibility, such as nickel-titanium, stainless steel and other materials. In some embodiments, the multi-turn wave-shaped rings 101 are arranged sequentially along the axial direction of the tubular body 10 from the proximal end to the distal end, preferably in parallel and at intervals.

The wave-shaped ring 101 includes a plurality of crests 101a, a plurality of troughs 101b, and a plurality of connecting rods 101c respectively connecting adjacent crests 101a and troughs 101b. The wave-shaped ring 101 is a closed cylindrical structure, and the multi-turn wave-shaped rings 101 may have the same or similar wave shapes. It can be understood that this embodiment does not limit the specific structure of the wave-shaped ring 101. The wave-shaped ring The waveform of the shape 101 can be set as required, and the number of waveforms and the height of the waveform in each wave ring 101 can be set as required.

The multi-circle corrugated ring 101 is connected with a coating 102, and the coating 102 is made of a polymer material with good biocompatibility, such as PTFE (Poly tetrafluoroethylene, polytetrafluoroethylene), FEP (Fluorinated ethylene propylene, Perfluoroethylene propylene copolymer) and PET (Polyethylene terephthalate, polyethylene terephthalate), etc.

In some embodiments, as shown in FIG. 12 and FIG. 13 , in the axial section where the wave-shaped ring 101 is located, there are at least two confinement channels 24 arranged at intervals on the tubular body 10 corresponding to the wave-shaped ring 101 . Correspondingly, the binding wires 22 in at least two binding channels 24 are respectively used to apply radial binding force to one side and the other side of the neutral coil of the wave-shaped ring 101 . Wherein, the neutral coil refers to the ring coil formed by sequentially connecting the midpoints of the connecting rods 101c in the wave-shaped ring 101 along the peripheral side of the tubular body 10 . Through this structural arrangement, the crests 101a and troughs 101b of the wave-shaped ring 101 are uniformly restrained, thereby avoiding the uneven force on the crests 101a and troughs 101b and causing them to be biased to one side, which in turn will cause the crests 101a or troughs 101b to warp and align with the blood vessels. Wall anchoring or contact friction is relatively large, which affects the adjustment of the axial and circumferential positions of the luminal stent.

Continuing to refer to FIG. 12 and FIG. 13 , the wave-shaped ring 101 also includes a first area A1 and a second area A2 that are opposite to each other along its axial direction and surround its circumference. The width D1 of the first area A1 is represented by the peak 101a is the starting point and extends axially toward the trough 101b for 2/5 times the wave height, that is to say, the two sides b1 and b2 defining the width D1 of the first region A1 surround the corresponding peak 101a of the wave-shaped ring 101 respectively. position, and the vertical distance to the peak 101a is 2/5 times the wave height. The width D2 of the second area A2 is 2/5 times the wave height starting from the wave trough 101b and extending axially toward the wave peak 101a, that is to say, the two sides b3 and b4 defining the width D2 of the second area A2 surround The position of the wave-shaped ring 101 corresponds to the trough 101b, and the vertical distance to the trough 101b is 2/5 times the wave height. It should be noted that the wave height refers to the vertical distance from the wave crest 101 a to the wave trough 101 b along the axis direction of the wave-shaped ring 101 .

At least one of the at least two confinement channels 24 is located in the first area A1, and at least one of the at least two confinement channels 24 is located in the second area A2. Therefore, the binding wires 22 located in the binding channel 24 respectively constrain the positions corresponding to the first area A1 and the second area A2 of the wave-shaped ring 101, so that the positions of the peaks 101a and the valleys 101b of the wave-shaped ring 101 are restricted. The force is uniform to improve the stability of the tubular body 10 and avoid the crests 101a or troughs 101b from warping.

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

The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims

A lumen stent, comprising a tubular body and a semi-releasing device connected to the tubular body, characterized in that the semi-releasing device comprises a binding wire and at least two limit rods arranged on the tubular body, The binding wire has a locking part, and the at least two limiting rods are limited to the tubular body at intervals along the circumferential direction of the tubular body, and are used for detachable connection with the locking part, wherein, when the When the limiting rod is connected to the locking part, the locking part is limited to the limiting rod along the radial direction of the limiting rod and makes the binding wire bind the tubular main body in a circumferential direction.
The endoluminal stent according to claim 1, wherein the binding wire is connected to the tubular body and folded in half to form a first strand bundle and a second strand bundle, and the folding position of the binding wire forms the locking part, the at least 2 limit rods are passed between the first wire bundle and the second wire bundle.
The endoluminal stent according to claim 2, wherein one of the at least two limiting rods is held in a direction opposite to the direction in which the binding wire encircles the tubular body. The tethering wire is bound at a connection location of the tethering wire to the tubular body.
The endoluminal stent according to claim 1, wherein the binding wire has a fixing part and at least two locking parts, the fixing part is fixedly connected with the tubular body, and the at least two limiting wires The rods are correspondingly passed through the at least two locking parts.
The endoluminal stent according to claim 4, wherein the at least two locking parts are located on the same side of the fixing part at intervals from each other.
The endoluminal stent according to claim 4, wherein the at least two locking parts are located on different sides of the fixing part at intervals from each other.
The endoluminal stent according to claim 1, wherein the binding wire has a fixing part and a wire loop, the fixing part is fixedly connected to the tubular body, and the end of the wire ring far away from the fixing part The locking part is formed at the upper part, and two or more limiting rods are passed through the wire loop.
The endoluminal stent according to claim 7, wherein the binding wire has at least two wire loops, and the at least two wire loops are located on the same side of the fixing part at intervals from each other.
The endoluminal stent according to claim 7, wherein the binding wire has at least two wire loops, and the at least two wire loops are located on different sides of the fixing part at intervals.
The endoluminal stent according to any one of claims 1-9, wherein a plurality of locking buckles are fixedly connected to the tubular body, and the at least two limit rods are respectively movable along their own axial directions. Piercing through a plurality of said lock buckles.
The endoluminal stent according to any one of claims 1-9, wherein the tubular body is fixedly connected with a plurality of locking buckles, the number of the locking buckles is equal to the number of the limit rods, more Each of the locking buckles correspondingly restricts the limiting rod to the tubular main body along the circumferential direction of the tubular main body.
The endoluminal stent according to claim 1, wherein a binding channel is provided on the tubular body, the central angle corresponding to the binding channel is less than 360°, and the binding channel is formed corresponding to the position of the limiting rod There is an opening, the opening communicates with the inner cavity of the restraint channel, the restraint wire is passed through the restraint channel, and the locking part is used to connect with the corresponding limit rod at the opening .
The endoluminal stent according to claim 12, wherein the tubular body comprises a wave-shaped ring, and in the axial section where the wave-shaped ring is located, the tubular body has at least 2 holes arranged at intervals. One of the binding channels corresponds to the wave-shaped ring, and the binding wires in the at least two binding channels are respectively used to apply a radial direction to one side and the other side of the median coil of the wave-shaped ring. binding.
The endoluminal stent according to claim 13, wherein the wave-shaped ring comprises a plurality of crests, a plurality of troughs, and a plurality of connecting rods respectively connecting the adjacent crests and the troughs, the The wave-shaped ring also includes a first region and a second region that are spaced apart from each other along its axial direction and surround its peripheral side. The width of the first region is from the peak to the trough in the axial direction Extending 2/5 times the wave height, the width of the second region is to extend 2/5 times the wave height from the trough in the axial direction to the wave peak direction, at least one of the at least 2 confinement channels is located at the In the first area, at least one of the at least two confinement channels is located in the second area.
The endoluminal stent according to claim 13 or 14, wherein the tubular body comprises multiple turns of the wave-shaped ring, and the wave-shaped ring of multiple turns extends from the proximal end along the axial direction of the tubular body Arranged sequentially to the far end.
The endoluminal stent according to claim 15, wherein multiple turns of the wave-shaped rings are arranged in parallel and at intervals.
The endoluminal stent according to claim 15, characterized in that, multiple turns of the wave-shaped ring are connected with a covering film, and the material of the covering film is polytetrafluoroethylene, perfluoroethylene propylene copolymer or polyparaffin. Ethylene glycol phthalate.
The endoluminal stent according to claim 15, characterized in that, multiple turns of the wave-shaped ring are connected with a coating, the outer surface of the coating is provided with a covering, and the binding channel is formed on the covering. between the object and the covering film.
The endoluminal stent according to claim 12, wherein the tubular body is provided with a plurality of limiting rings, and the plurality of limiting rings form the binding channel.
The endoluminal stent according to claim 1, characterized in that it comprises a branch window, and the branch window is arranged at a part of the tubular body between the corresponding two limiting rods.