CN112891017A

CN112891017A - Lumen stent

Info

Publication number: CN112891017A
Application number: CN201911222561.5A
Authority: CN
Inventors: 肖本好; 唐春炜
Original assignee: Shenzhen Xianjian Changtong Medical Co ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-03
Filing date: 2019-12-03
Publication date: 2021-06-04
Anticipated expiration: 2039-12-03
Also published as: CN112891017B

Abstract

The invention discloses a lumen stent, which comprises a tubular main body and a half-releasing device connected to the tubular main body, wherein the half-releasing device comprises a limiting rod positioned in the tubular main body and a binding line wound on the inner surface of the tubular main body, at least two locking parts are arranged on the binding line, the at least two locking parts are connected with the limiting rod in a separable mode, and when the at least two locking parts are connected with the limiting rod, the binding line circumferentially restrains the tubular main body. The invention has the beneficial effects that: this application sets up half release structure in lumen support, makes lumen support's surface smooth, even lumen support touches the vascular wall when position adjustment, also can not cause the harm to the vascular wall to smooth surface can reduce the frictional resistance between lumen support and the vascular wall, and the convenience is adjusted lumen support's position.

Description

Lumen stent

Technical Field

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

Background

In more than ten years, aorta covered stent endoluminal isolation has been widely applied to lesions such as thoracic and abdominal aortic aneurysms and arterial dissections, has definite curative effect, small wound, quick recovery and few complications, and becomes a first-line treatment method. During operation, under the X-ray fluoroscopy monitoring, the covered stent is conveyed to the pathological change position through the corresponding conveying system, the covered stent isolates blood flow from the pathological change position, and the influence of blood pressure on the pathological change position is eliminated, so that the purpose of curing is achieved.

In order to solve the problem of positioning the stent graft in vivo, development marks are usually made at the key positions of the stent graft, and the development marks are used for positioning the stent graft in the axial direction and the circumferential direction. However, when the stent graft is compressed in the delivery sheath, the stent graft has compression wrinkles in the circumferential direction and is in an extended state in the axial direction, and when the stent graft is positioned by the development marker in this case, there is a large deviation in the circumferential direction and the axial direction.

Disclosure of Invention

The present invention is directed to a lumen stent, which solves the above-mentioned drawbacks of the prior art.

The technical scheme adopted by the invention for solving the technical problems is as follows:

the pipe cavity bracket comprises a tubular main body and a semi-releasing device connected to the tubular main body, wherein the semi-releasing device comprises a limiting rod positioned in the tubular main body and a binding line wound on the inner surface of the tubular main body, at least two locking parts are arranged on the binding line and are connected with the limiting rod in a separable mode, and when the at least two locking parts are connected with the limiting rod, the binding line circumferentially restrains the tubular main body.

In the lumen stent, the inner surface of the tubular main body is provided with a binding channel, the binding line is positioned in the binding channel, and the locking part penetrates out of the binding channel and is connected with the limiting rod.

In the lumen stent, the inner surface of the tubular main body is provided with a film, the binding channel is formed between the film and the covering film, the film is provided with a wire hole communicated with the inner cavity of the binding channel, and the binding wire passes through the wire hole.

In the lumen stent, the inner surface of the tubular main body is provided with a plurality of limiting ring buckles, the binding channel consists of the limiting ring buckles, and the binding line penetrates through the limiting ring buckles.

In the luminal stent of the present invention, the tubular body comprises a plurality of rings of wavy rings, the wavy rings comprise a plurality of peaks, a plurality of valleys and a plurality of connecting rods respectively connecting the adjacent peaks and valleys;

the number of the limiting buckles is multiple, in a natural state, the linear distance between the adjacent limiting buckles is e, the vertical distance between the fixed point of the limiting buckle and the trough which is located below the limiting buckle and is closest to the limiting buckle is f, and the e and the f meet the condition that the e is less than or equal to 2 f.

In the luminal stent of the present invention, the tubular main body comprises a first zone and a second zone distributed along a circumferential direction, and the constraint line is disposed on the second zone.

In the luminal stent of the present invention, the circumferential angle covered by the second zone is 180 ° to 340 °.

In the luminal stent of the invention, the number of the limiting rods is at least two.

In the lumen stent, a fixing part is arranged on the binding line, and the binding line is fixedly connected with the tubular main body through the fixing part.

In the lumen stent, the ratio of the diameter of the circumcircle of the cross section of the lumen stent in a semi-release state to the diameter of the circumcircle of the cross section of the lumen stent in a complete expansion state is 0.6-0.8.

In summary, the lumen stent of the present invention has the following advantages: this application is through setting up half release on lumen stent, this half release can improve lumen stent's axial and the accuracy of circumference location to with half release structure setting in lumen stent, make lumen stent's surface smooth, even lumen stent touches the vascular wall when position adjustment, also can not cause the harm to the vascular wall, and smooth surface can reduce the frictional resistance between lumen stent and the vascular wall, conveniently adjusts lumen stent's position.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

FIG. 1 is a schematic view of a lumen stent provided in accordance with one embodiment of the present invention in a semi-released state;

FIG. 2 is a top view of the luminal stent shown in FIG. 1;

FIG. 3 is an enlarged view of section A of the luminal stent shown in FIG. 1;

FIG. 4 is a schematic view of the luminal stent shown in FIG. 1 fully deployed;

FIG. 5 is a top view of the luminal stent shown in FIG. 4;

FIG. 6 is a B-B cross-sectional view of the luminal stent shown in FIG. 4;

FIG. 7 is a schematic view of the constraining channel of the luminal stent of FIG. 1 comprised of a plurality of stop loops;

FIG. 8 is a schematic view of the ligature of the luminal stent of FIG. 7 crossing a trough;

FIG. 9 is a schematic view of the luminal stent shown in FIG. 7 with the leash line not crossing the trough;

FIG. 10 is a schematic view of the constraining channel of the luminal stent of FIG. 1 having a plurality of wire holes and the luminal stent in a semi-released state;

FIG. 11 is a schematic view of the luminal stent of FIG. 10 fully deployed;

FIG. 12 is a schematic view of a second embodiment of the invention providing a lumen stent in a semi-released state;

FIG. 13 is a schematic illustration of the luminal stent of FIG. 12 after a stage of constraint has been relieved;

FIG. 14 is a schematic illustration of the luminal stent of FIG. 12 after the secondary constraint is removed;

FIG. 15 is a schematic view of a lumen stent in a semi-released state according to a third embodiment of the present invention;

FIG. 16 is a schematic view of the luminal stent of FIG. 15 fully deployed;

FIG. 17 is a schematic view of a lumen stent in a semi-released state according to a fourth embodiment of the present invention.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

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

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. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In the field of interventional medicine, it is commonly defined that a luminal stent is proximal to the heart at the end proximal to the heart and distal to the heart after release.

Referring to fig. 1, in one embodiment, a lumen stent 100 is provided, which includes a bare stent and a covering membrane 102 connected to the bare stent. The luminal stent 100 is a hollow luminal structure, and the lumen of the luminal stent 100 constitutes a passage through which blood flows.

Wherein, the bare stent is made of materials with good biocompatibility, such as nickel titanium, stainless steel and the like. The covering membrane 102 is made of a polymer material with good biocompatibility, such as PTFE, FEP, PET, and the like. The bare stent comprises a plurality of circles of wavy rings 101 (as shown in fig. 7), each circle of wavy ring 101 comprises a plurality of wave crests, a plurality of wave troughs and a plurality of connecting rods respectively connecting adjacent wave crests and wave troughs, and the plurality of circles of wavy rings 101 are sequentially arranged from the proximal end to the distal end, preferably in parallel at intervals. The wavy ring 101 is a closed cylindrical structure, and the multiple circles of wavy rings 101 may have the same or similar wavy shapes, and it is understood that the present embodiment does not limit the specific structure of the wavy ring 101, the wavy ring 101 may have any wavy shape as required, and the number of wavy waves and the height of the wavy waves in each circle of the wavy ring 101 may be set as required.

Referring to fig. 1, the luminal stent 100 comprises a tubular body 11 and a semi-releasing device 20 connected to the tubular body 11 for circumferentially constraining the tubular body 11. The half release device 20 includes a stopper rod 21 inside the tubular body 11, and a binding line 22 wound around the inner surface of the tubular body 11.

Referring to fig. 1, 2 and 3, the inner surface of the tubular body 11 is provided with a restraint passage 110, the leash line 22 is positioned in the restraint passage 110, and the leash line 22 is provided with at least two locking parts 221. The restraint passage 110 is provided with at least two line holes 111, and the restraint line 22 enters the inside of the tubular body 11 through the line holes 111 and connects the at least two locking parts 221 with the stopper rod 21 in a detachable manner. When the stopper rod 21 is connected to the lock portion 221, the trap line 22 circumferentially traps the tubular body 11. Referring to fig. 4 and 5, when the stopper rod 21 is separated from the locking part 221, the locking part 221 is released from the stopper rod 21, and the leash line 22 moves from the line hole 111 into the leash passage 110 by the radial supporting force of the tubular body 11 until the tubular body 11 is completely spread.

This application is through setting up half release 20 on lumen support 100, after lumen support 100 released from carrying the sheath pipe, under this half release 20's restraint, lumen support 100 was in half release state, and lumen support 100 did not laminate with the vascular wall this moment, and the operator still can adjust the axial and the circumferential direction position of lumen support 100, after locating accurately, again with half release 20's restraint release, make lumen support 100 expand the adherence.

However, when the luminal stent 100 is in the half-released state and the operator adjusts the axial and circumferential positions of the luminal stent 100, the luminal stent 100 is likely to touch the vessel wall, and particularly in the case where the vessel is curved, the luminal stent 100 inevitably touches the vessel wall when the position of the luminal stent 100 is adjusted. This application sets up half release structure 20 in lumen support 100, makes lumen support 100's surface smooth, even lumen support 100 touches the vascular wall, can not cause the harm to the vascular wall yet to smooth surface can reduce the frictional resistance between lumen support 100 and the vascular wall, conveniently adjusts lumen support 100's position.

Further, the gag lever post 21 of this application is located lumen support 100, can avoid gag lever post 21 to damage the blood vessel at the in-process of lumen support 100 positioning adjustment, reduces the risk that the tip of gag lever post 21 touched the angiogenesis and bent, and does not occupy the adjustment space between lumen support 100 and the vascular wall, especially to the complicated condition of intracavity structure, does benefit to lumen support 100's adjustment and positioning.

It can be understood that, if the luminal stent 100 is in a semi-released state, the circumscribed circle of the cross section of the luminal stent 100 has an excessively large diameter, and the luminal stent 100 is easy to adhere to the wall, which is not beneficial to the axial and circumferential adjustment of the luminal stent; if the diameter of the circumscribed circle of the cross section of the luminal stent 100 is too small when the luminal stent is in a half-release state, the half-release effect is not large, and a large positioning deviation in the circumferential direction and the axial direction still exists. Therefore, in the present embodiment, the ratio of the circumscribed circle diameter of the cross section of the luminal stent 100 in the semi-released state to the circumscribed circle diameter of the cross section of the luminal stent 100 in the deployed state is 0.6 to 0.8.

In the embodiment shown in fig. 1 to 6, the inner surface of the tubular main body 11 is provided with the film 12 distributed along the circumferential direction, the binding passage 110 is formed between the film 12 and the covering film 102, and the binding line 22 is movably located in the binding passage 110. At least two wire holes 111 are formed on the film 12, the wire holes 111 communicate with the inner cavity of the restraint channel 110, and the locking part 221 of the restraint line 22 enters the inside of the tubular main body 11 through the wire holes 111 and is detachably connected with the stopper rod 21. The locking part 221 is preferably a snap ring structure or a semicircular ring structure formed by folding the binding line 22 in half, and the stopper rod 21 may be inserted through the snap ring structure or the semicircular ring structure.

The binding passage 110 may include a plurality of binding passages 110, the plurality of binding passages 110 are axially spaced apart from each other on the inner surface of the tubular body 11, and each binding passage 110 is annular. Each binding channel 110 encloses a binding line 22, and the binding line 22 enclosed therein is also circular. The leash line 22 may be a flexible line with strong tensile properties, such as a polyester suture, etc. The leash line 22 may be composed of a single flexible line or may be composed of a plurality of flexible lines.

It is understood that, although the binding channel 110 of the present embodiment is formed between the membrane 12 and the covering membrane 102, the present embodiment does not limit the specific forming manner of the binding channel 110, for example, in the embodiment shown in fig. 7, the inner surface of the tubular main body 11 is provided with a plurality of limiting buckles 23, the binding channel 110 is composed of a plurality of limiting buckles 23, and the binding line 22 is in a circular ring shape and penetrates through the limiting buckles 23.

Referring to fig. 7 and 8, if the distance between the two retaining ring fasteners 23 is too long, when the luminal stent 100 is in a completely radially compressed state in the sheath, the restraining line 22 is in a loose state, and the restraining line 22 between the two retaining ring fasteners 23 is axially displaced, even passing over and hooking on the trough of the wave-shaped ring 101. When the luminal stent 100 is completely released from the delivery sheath, the lashing lines 22 hook over the wavy loops 101, which may cause the luminal stent 100 to fail to deploy properly.

Referring to fig. 7 and 9, in a natural state (i.e., when the lumen stent 100 is completely released), a linear distance between two adjacent limiting buckles 23 is e, and a vertical distance between a fixing point of the limiting buckle 23 and a trough located below the limiting buckle 23 and closest to the limiting buckle 23 is f, where e and f satisfy e ≦ 2f, so as to prevent the constraint line 22 from crossing the trough of the corrugated ring 101 when the lumen stent 100 is in a radially compressed state.

Preferably, the limiting ring buckle 23 is located in the middle of the connecting rod of the wavy ring 101, which is not only beneficial to the radial compression of the lumen stent 100 by the constraint line 22, so that the stress of the wavy ring 101 is uniform, but also can reduce the damage risk of the constraint line 22 to the covering film.

Preferably, the wavy ring 101 is located on the inner surface of the covering film 102, so that the outer surface of the lumen stent 100 is smoother, and the position of the lumen stent 100 can be conveniently adjusted.

It is also understood that the present embodiment does not limit the number of the string holes 111 of the binding passage 110, for example, in the embodiment shown in fig. 10 and 11, three string holes 111 are provided on the binding passage 110, three locking parts 221 are provided on the binding string 22, and the binding string 22 enters the inside of the tubular body 11 through the string holes 111 and connects the three locking parts 221 with the stopper rod 21 in a detachable manner. By arranging the plurality of locking parts 221 and the line holes 111, when the limiting rod 21 is separated from the locking parts 221, the binding line 22 can move from the plurality of line holes 111 to the inside of the binding channel 110, so that the lumen stent 100 can be expanded and attached to the wall more quickly.

One of ordinary skill in the art should appreciate that the luminal stent of the present embodiment is only used as an example and not limiting to the present application, and the implant of the present application can be any covered luminal stent with a bare stent, including but not limited to thoracic aortic stent, abdominal aortic stent, thoraco-abdominal aortic stent, etc.

Referring to fig. 12, 13 and 14, a second embodiment of the present application provides a lumen stent 100, which is substantially the same as the lumen stent of the first embodiment, the lumen stent 100 includes a tubular main body 11 and a half-release device 20 connected with each other, the half-release device 20 includes a stopper 21 located in the tubular main body 11, and a constraint line 22 wound on an inner surface of the tubular main body 11, the inner surface of the tubular main body 11 is provided with a constraint channel 110, and the constraint line 22 is located in the constraint channel 110.

The second embodiment is different from the first embodiment in that the two limiting rods 21 include a first limiting rod 21a and a second limiting rod 21 b. The leash line 22 is provided with four locking parts 221, two locking parts 221 of the four locking parts 221 are detachably connected with the first stopper rod 21a, and the other two locking parts 221 of the four locking parts 221 are detachably connected with the second stopper rod 21 b.

This embodiment is through setting up two at least gag lever posts 21, can carry out hierarchical regulation to the half release function of lumen support 100, once fix a position accurate back, removes the primary restraint, carries out the secondary and fixes a position again, removes the secondary restraint. Fig. 12 is a schematic view of the luminal stent 100 in a half-released state after being released from the delivery sheath, in which the two stop bars 21 are respectively connected to the four locking portions 221. Fig. 13 is a schematic view after the lumen stent 100 is released from the first order, in which only one stopper rod 21 is connected to two locking parts 221. Fig. 14 is a schematic view after the second-stage constraint of the lumen stent 100 is released, in which the two stopper rods 21 are separated from the four locking parts 221, and the lumen stent 100 is completely deployed.

Referring to fig. 15 and 16, a third embodiment of the present invention provides a lumen stent 100, which is substantially the same as the lumen stent of the first embodiment, the lumen stent 100 includes a tubular main body 11 and a half-release device 20 connected with each other, the half-release device 20 includes a stopper rod 21 disposed in the tubular main body 11, and a constraint line 22 wound on an inner surface of the tubular main body 11, the inner surface of the tubular main body 11 is provided with a constraint channel 110, and the constraint line 22 is disposed in the constraint channel 110.

The third embodiment is different from the first embodiment in that the tether line 22 partially tethers the tubular body 11, the tubular body 11 includes a first region 11a and a second region 11b distributed in a circumferential direction, and the tether line 22 is provided on the second region 11 b.

In the embodiment shown in fig. 15 and 16, the tethering channel 110 is located on the second region 11b, and the leash line 22 is provided with two fastening parts 24, and the leash line 22 is fastened in the tethering channel 110 by the fastening parts 221, so that the leash line 22 is prevented from escaping from the tethering channel 110 into the downstream blood vessel. The restraint channel 110 is provided with at least two line holes 111, the restraint line 22 is provided with at least two locking parts 221, and the restraint line 22 enters the interior of the tubular main body 11 through the line holes 111 and enables the at least two locking parts 221 to be detachably connected with the stop rod 21.

When the luminal stent 100 is released from the delivery sheath and in a semi-released state, the first region 11a of the luminal stent 100 is fully deployed, and at this time, the operator can accurately position the first region 11 a. After the constraint of the constraint line 22 is released, in the process of gradually expanding the constrained portion (the second region 11b) of the luminal stent 100, the first region 11a has no expansion motion, and the circumferential alignment error of the first region 11a is greatly reduced. Therefore, when the tubular main body 11 is provided with a component having a high positioning requirement, such as a branch, a branch window, a keel, etc., the component having a high positioning requirement may be provided in the first region 11a, and only the second region 11b of the lumen stent 100 may be circumferentially constrained, thereby improving the positioning accuracy.

It can be understood that if the range of the constraint area of the second region 11b along the circumferential direction is too small, the degree of compression of the stent in the constraint area along the radial direction is large, and during the expansion process of the stent, the stent in the constraint area is not fully expanded, and the stents in other areas adhere to the wall, so that a large groove is formed in the constraint area, the stent is not adhered to the wall as a whole, and the risk of internal leakage is increased. However, if the range of the constrained region of the second region 11b in the axial direction is too large, the local constraint of the lumen stent 100 is of little significance. Therefore, in the present embodiment, when the luminal stent 100 is completely deployed, the circumferential angle covered by the second zone 11b is 180 ° to 340 °.

Referring to fig. 17, a lumen stent 100 is provided according to the fourth embodiment of the present application, which is substantially the same as the lumen stent of the first embodiment, the lumen stent 100 includes a tubular main body 11 and a half-release device 20 connected to each other, the half-release device 20 includes a limiting rod 21 disposed in the tubular main body 11, and a constraint line 22 wound on an inner surface of the tubular main body 11, the inner surface of the tubular main body 11 is provided with a constraint channel 110, and the constraint line 22 is disposed in the constraint channel 110.

The fourth embodiment differs from the first embodiment in that the binding channels are helically distributed on the inner surface of the tubular body 11.

Specifically, the inner surface of the tubular main body 11 is provided with a plurality of spirally distributed limit buckles 23, the plurality of spirally distributed limit buckles 23 form the bound passage, and the bound line 22 penetrates through the limit buckles 23. Two locking parts 221 are provided at both ends of the leash line 22, and the two locking parts 221 are detachably connected with the stopper rod 21.

Since the tether line 22 is spirally wound around the inner surface of the tubular body 11, the present embodiment can achieve uniform compression of the entire luminal stent 100 by one tether line 22.

The plurality of limiting buckles 23 are spirally distributed on the inner surface of the tubular main body 11, and the limiting buckles 23 can limit the axial position of the constraint line 22, so that the constraint line 22 can be better compressed uniformly in a spiral mode on the lumen stent 100.

The leash line 22 further comprises at least one fixing portion 24, and the leash line 22 is fixed on the tubular body 11 through the fixing portion 221, when the leash line 22 slides down from all the position-limiting ring buckles 24, the fixing portion 221 can prevent the leash line 22 from separating from the lumen stent 100 and entering into the downstream blood vessel.

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

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

Claims

1. A lumen stent comprises a tubular main body and a semi-releasing device connected to the tubular main body, and is characterized in that the semi-releasing device comprises a limiting rod positioned in the tubular main body and a binding line wound on the inner surface of the tubular main body, at least two locking parts are arranged on the binding line, the at least two locking parts are detachably connected with the limiting rod, and when the at least two locking parts are connected with the limiting rod, the binding line circumferentially restrains the tubular main body.

2. The luminal stent as defined in claim 1, wherein the inner surface of the tubular body is provided with a binding channel, the binding line is positioned in the binding channel, and the locking part passes through the binding channel and is connected with the stop bar.

3. The luminal stent as claimed in claim 2, wherein the inner surface of the tubular main body is provided with a membrane, the binding channel is formed between the membrane and the covering membrane, the membrane is provided with a thread hole communicated with the inner cavity of the binding channel, and the binding thread passes through the thread hole.

4. The luminal stent as defined in claim 2, wherein the inner surface of the tubular body is provided with a plurality of stop buckles, the restraint channel is composed of the plurality of stop buckles, and the restraining line is penetrated through the stop buckles.

5. The luminal stent of claim 4 wherein the tubular body comprises a plurality of turns of a wavy ring, the wavy ring comprising a plurality of peaks, a plurality of valleys and a plurality of connecting rods connecting adjacent ones of the peaks and valleys, respectively;

6. The luminal stent of claim 1, wherein the tubular body comprises a first zone and a second zone distributed along a circumferential direction, the leash line being disposed on the second zone.

7. The luminal stent of claim 6 wherein the circumferential angle covered by the second zone is between 180 ° and 340 °.

8. The luminal stent of claim 1 wherein the number of stop rods is at least two.

9. The luminal stent as defined in claim 1, wherein the tethering line is provided with a securing portion, and the tethering line is fixedly connected with the tubular body through the securing portion.

10. The luminal stent as claimed in claim 1 wherein the ratio of the circumscribed circle diameter of the cross section of the luminal stent in the semi-released state to the circumscribed circle diameter of the cross section of the luminal stent when fully deployed is 0.6 to 0.8.