CN111329633B

CN111329633B - Implant and method of manufacturing the same

Info

Publication number: CN111329633B
Application number: CN201811549944.9A
Authority: CN
Inventors: 唐春炜; 肖本好
Original assignee: Shenzhen Xianjian Changtong Medical Co ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2018-12-18
Filing date: 2018-12-18
Publication date: 2022-03-08
Anticipated expiration: 2038-12-18
Also published as: CN111329633A

Abstract

The invention discloses an implant, which comprises a tubular main body and a semi-release device connected to the outer surface of the tubular main body, wherein the semi-release device comprises a limiting rod and a plurality of binding units movably connected with the limiting rod, each binding unit comprises a binding line, a locking assembly and at least one limiting buckle, the locking assembly is connected to the binding line, the limiting buckles are fixed on the tubular main body, the binding line and/or the locking assembly penetrate from one side to the other side of the limiting buckle, and when the limiting rod is sleeved in the locking buckle assembly, the binding line circumferentially restrains the tubular main body. The invention has the beneficial effects that: the limiting ring buckle is arranged on the outer surface of the tubular main body, so that the constraint line can be uniformly compressed on the tubular main body, the accuracy of the overall positioning of the stent is improved, and when the implant is compressed in the sheath of the conveyor or the constraint of the constraint line on the implant is relieved, the limiting ring buckle can also prevent the constraint line from axially moving.

Description

Implant and method of manufacturing the same

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to an implant.

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 solving the above-mentioned problems of the prior art, and providing an implant.

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

the implant comprises a tubular main body and a semi-release device connected to the outer surface of the tubular main body, wherein the semi-release device comprises a limiting rod and a plurality of binding units movably connected with the limiting rod, each binding unit comprises a binding line, a locking assembly and at least one limiting buckle, the locking assembly is connected to the binding line, the limiting buckles are fixed on the tubular main body, the binding line and/or the locking assembly penetrate from one side to the other side of the limiting buckle, and when the limiting rod is sleeved in the locking buckles, the binding line circumferentially restrains the tubular main body.

In summary, the implant of the present invention has the following advantages: through setting up half release at lumen support's surface, after lumen support releases completely from carrying the sheath pipe, under this half release's restraint, lumen support is in half release state, and lumen support and vascular wall do not laminate this moment, and the operator still can adjust lumen support's axial and circumferential position, after the accuracy of awaiting fixing a position, again with half release's restraint release, make lumen support expand the adherence. And the limiting ring buckle is arranged on the outer surface of the tubular main body, and the constraint line and/or the locking buckle assembly penetrate from one side of the limiting ring buckle to the other side, so that the constraint line can be uniformly compressed in the tubular main body, the accuracy of the integral positioning of the stent is improved, and the limiting ring buckle can also prevent the constraint line from axially moving after the implant is compressed in a sheath of a conveyor or the constraint of the constraint line on the implant is relieved.

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

FIG. 3 is a schematic view of the loop configuration of the first locking device of the luminal stent shown in FIG. 1;

FIG. 4 is a schematic view of the first locking device of the luminal stent shown in FIG. 1 in a non-circular configuration;

FIG. 5 is a schematic view of a leash line on the luminal stent of FIG. 1 crossing a trough;

FIG. 6 is a schematic view of a stop collar on the luminal stent of FIG. 1;

FIG. 7 is a schematic view of a leash line on the luminal stent of FIG. 1 without crossing a trough;

FIG. 8 is a schematic view of a positioning member disposed on a tether line of the luminal stent shown in FIG. 1;

FIG. 9 is a schematic view of the luminal stent of FIG. 1 with the primary locking device and the stop collar locked together;

FIG. 10 is a schematic view of a lumen stent provided in accordance with a second embodiment of the present invention 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 lumen stent in a semi-released state according to a third embodiment of the present invention;

FIG. 13 is a schematic view of the luminal stent of FIG. 12 fully deployed;

FIG. 14 is a rear view of the luminal stent shown in FIG. 12;

FIG. 15 is a schematic view of a lumen stent in a semi-released state according to the fourth 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 the tubular body of the luminal stent of FIG. 16;

FIG. 18 is a schematic view of the luminal stent of FIG. 16 placed within the tumor lumen;

FIG. 19 is a schematic illustration of four windows in the tapered section of the luminal stent shown in FIG. 16 being of equal area;

FIG. 20 is a schematic illustration of the area of the inner branch window being greater than the area of the outer branch window on the tapered section of the luminal stent shown in FIG. 16;

FIG. 21 is a schematic view of the undulating rings of the tapered section of the luminal stent shown in FIG. 16;

FIG. 22 is a schematic view of the closed connection of the distal outer wall of the inner branch of the luminal stent of FIG. 16 with the inner wall of the tubular body;

FIG. 23 is a schematic view of the lumen stent of FIG. 16 with struts disposed on the inner branches;

FIG. 24 is a schematic view of the support rod of FIG. 23 extending to the distal end of the inner branch;

FIG. 25 is a schematic view of the inner branch of FIG. 16 with the proximal end face obliquely disposed;

FIG. 26 is a schematic view of the luminal stent of FIG. 16 with barbs thereon;

FIG. 27 is a schematic view of the distal undulating ring of the inner branch of the luminal stent of FIG. 16 positioned over the proximal undulating ring of the outer branch;

FIG. 28 is a schematic view of the distal end of the inner branch of the luminal stent of FIG. 16 positioned above the distal end of the outer branch;

FIG. 29 is a schematic view of the distal end of the inner branch of the luminal stent of FIG. 16 positioned over the proximal end of the outer branch.

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 generally defined that the end of the implant that is proximal to the heart after release is the proximal end and the end that is distal to the heart is the distal end.

An implant is provided that can be received within a delivery sheath in a compressed state and that automatically returns to a predetermined configuration upon release from the delivery sheath. The implant can be products such as lumen stents, valves, occluders, filters, etc.

Referring to fig. 1, one embodiment of the present application provides an implant, which is a luminal stent 100, comprising a bare stent 101 and a covering membrane 102 connected to the bare stent 101. The luminal stent 100 is a hollow luminal structure, and the lumen of the luminal stent 100 constitutes a passage through which blood flows.

The bare stent 101 is made of a material 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 101 comprises a plurality of circles of wavy rings 1011, each circle of wavy ring 1011 comprises a plurality of wave crests, a plurality of wave troughs and a plurality of connecting rods for respectively connecting the adjacent wave crests and the wave troughs, and the plurality of circles of wavy rings 1011 are sequentially arranged from the near end to the far end, preferably in parallel at intervals. The wavy rings 1011 are closed cylindrical structures, and multiple circles of the wavy rings 1011 can have the same or similar wavy shapes, and it is understood that the specific structure of the wavy rings 1011 is not limited in this embodiment, the wavy rings 1011 can have the wavy shapes set as required, and the number of the wavy shapes and the heights of the wavy shapes in each circle of the wavy rings 1011 can be set as required.

Referring to fig. 1 and 2, the luminal stent 100 comprises a tubular body 11 and a semi-releasing device 200 attached to the outer surface of the tubular body 11 to circumferentially constrain the tubular body 11. The half release device 200 includes a stopper rod 21, and a plurality of binding units 20 movably connected to the stopper rod 21. Wherein, the binding unit 20 comprises a binding line 22, a locking assembly 23 and at least one limit buckle 24, the locking assembly 23 is connected to the binding line 22, the limit buckle 24 is fixed on the tubular main body 11, and the binding line 22 and/or the locking assembly 23 pass through from one side to the other side of the limit buckle 24. When the limiting rod 21 is sleeved in the locking component 23, the constraint line 22 circumferentially constrains the lumen main body 10 nearby. Specifically, the locking assembly 23 includes a first locking catch 231 connected to the lashing line 22, and a second locking catch 232 connected to the lashing line 22 or/and the tubular body 11, and the limiting rod 21 is movably connected in the first locking catch 231 and the second locking catch 232.

This application is through setting up half release 200 at lumen support 100's surface, after lumen support 100 releases completely from carrying the sheath pipe, under this half release 200's restraint, lumen support 100 is in half release state, lumen support 100 does not laminate with the vascular wall this moment, the operator still can adjust the axial and the circumferential position of lumen support 100, after accurate to be positioned, again with half release 200's restraint release, make lumen support 100 expand the adherence. It can be understood that, when the luminal stent 100 is in a semi-released state, the circumscribed circle of the cross section of the luminal stent is too large in diameter, so that the stent is easy to adhere to the wall, which is not beneficial to the axial and circumferential adjustment of the 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 and 2, a plurality of binding units 20 are uniformly distributed on the outer surface of the tubular body 11 along the axial direction, and each binding unit 20 is distributed along the circumferential direction, so as to uniformly bind the tubular body 11. The binding unit 20 includes a plurality of limit buckles 24 uniformly distributed in a circumferential direction, and the binding line 22 is penetrated through each limit buckle 24. The first locker 231 and the second locker 232 are both ring structures, the first locker 231 is disposed at one end of the leash line 22, and the second locker 232 is disposed at the other end of the leash line 22. During assembly, the limiting rod 21 is respectively sleeved in the first lock catch 231 and the second lock catch 232, and after accurate positioning is achieved, the limiting rod 21 is pulled out of the first lock catch 231 and the second lock catch 232 so as to remove constraint. It is understood that the present embodiment does not limit the specific positions of the first and

second lockers

231 and 232 on the leash line 22, and in other embodiments, the first or

second lockers

231 and 232 may be located in other areas outside the end of the leash line 22. It will also be appreciated that the present embodiment is not limited to a specific number of secondary catches 232, for example, the secondary catches 232 may also include two secondary catches 232, one of the secondary catches 232 being attached to the leash line 22 and the other secondary catch 232 being attached to the tubular body 11.

This application is through setting up a plurality of spacing buckles 24 at tubular main part 11's surface to make constraint line 22 and/or lock catch subassembly 23 wear to establish from spacing buckle 24, can make the even compression tubular main part 11 of constraint line 22, improve the accuracy of support overall positioning. Moreover, the limiting ring 24 can prevent the binding line 22 from being axially displaced when the lumen stent 100 is compressed in the delivery sheath or the binding of the binding line 22 to the lumen stent 100 is released.

It will be appreciated that in other embodiments, the catch assembly 23 passes from one side of the stop collar 24 to the other, for example, in the embodiment shown in fig. 3, the first catch 231 is a ring-shaped structure that is attached to one end of the leash line 22, and the first catch 231 is hooked on the stop collar 24.

It should be understood that the present embodiment does not limit the specific structure of the first latch 231 and the second latch 232, as long as the limiting rod 21 can be movably connected in the first latch 231 and the second latch 232. For example, in the embodiment shown in fig. 4, the first locking fastener 231 is not a closed loop structure, and the first locking fastener 231 is hooked on the limit buckle 24, that is, the first locking fastener 231 is passed from one side of the limit buckle 24 to the other side and then folded back, and at this time, the lashing line 22 and the first locking fastener 231 are integrated into a whole structure.

It can also be understood that if the number of the position-limiting ring fasteners 24 is too small, the distance between two adjacent position-limiting ring fasteners 24 is too long, and when the half-releasing device 200 is released, the area between two position-limiting ring fasteners 24 of the luminal stent 100 is easily depressed, so that the stent in the area cannot be spread to adhere to the wall. Furthermore, as shown in fig. 5, if the distance between the two position-limiting buckles 24 is too long, when the lumen stent 100 is in a radially compressed state, the binding line 22 between the two position-limiting buckles 24 will axially shift, even go over the trough of the wavy ring 101 and hook on the trough, so that the stent cannot be normally deployed.

Referring to fig. 6 and 7, a linear distance between two adjacent limiting buckles 24 is e, and a vertical distance between a fixed point of the limiting buckle 24 and a trough located below the limiting buckle 24 and closest to the limiting buckle 24 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. In this embodiment, the limiting buckles 24 are all arranged on the wave-shaped ring 1011, which not only facilitates radial compression of the stent, but also reduces the risk of damage to the covering membrane by the constraint line 22. Preferably, the position-limiting ring 24 is located at the middle of the connecting rod of the corrugated ring 1011 to make the force applied to the corrugated ring 101 uniform.

Furthermore, an anti-falling structure is arranged between the locking assembly 23 and the limiting buckle 24 to prevent the locking assembly 23 from sliding off the limiting buckle 24 after the constraint is released, so that the constraint line 22 is axially displaced. In the embodiment shown in fig. 8, the separation preventing structure is a positioning member 25 provided at the connection of the leash line 22 and the first locker 231 or/and the second locker 232, and the outer diameter of the positioning member 25 is greater than the inner diameter of the retainer ring 24 so that the positioning member 25 cannot pass through the retainer ring 24. It will be appreciated that the present embodiment does not limit the specific location of the locating member 25 on the leash line 22, for example, in other embodiments, the locating member 25 is located between two stop buckles 24. It will also be appreciated that in other embodiments, the anti-slip structure may not be provided, and the locking assembly 23 and the spacing buckle 24 are prevented from slipping off in other ways, for example, in the embodiment shown in fig. 9, the first lock 231 is hooked with the spacing buckle 24 to prevent the locking assembly 23 from slipping off the spacing buckle 24.

It can be understood that if the size of the limit buckle 24 is too large, the range of the movement of the constraint line 22 along the axial direction is large, which affects the radial compression effect of the stent, but if the size of the limit buckle 24 is too small, the friction force between the limit buckle 24 and the constraint line 22 is increased, which affects the circumferential relative movement of the two, which is not beneficial to the smooth expansion of the stent. Therefore, in the present embodiment, the ratio of the area of the position-limiting buckle 24 to the cross-sectional area of the constraint line 22 is 1.1-2. It should be noted that, when the limit buckle 24 is annular, the "area of the limit buckle 24" refers to the inner area of the limit buckle; when the limit buckle 24 is a line segment with two ends fixed on the tubular body 11, the "area of the limit buckle 24" refers to the area enclosed by the limit buckle 24 and the tubular body 11.

Referring to fig. 2 again, the leash line 22 further includes at least one fixing portion 221, the fixing portion 221 may be fixed on the tubular body 11 by sewing or bonding, and when the leash line 22 slides down from all the position-limiting ring fasteners 24, the fixing portion 221 may prevent the leash line 22 from separating from the stent and entering the downstream blood vessel. In the embodiment shown in fig. 2, the fixing part 221 is located at the end of the constraint line 22.

In this embodiment, the constraint line 22 may be a flexible line with strong stretch resistance, such as a polyester suture. The leash line 22 may be composed of a single flexible line or may be composed of a plurality of flexible lines. The position-limiting ring fastener 24, the first fastener 231 and the second fastener 232 can be polyester suture coils or nickel-titanium metal rings and the like. The limiting rod 21 can be a metal guide wire with small surface roughness and good biocompatibility with a human body, such as a nickel-titanium wire. In order to avoid increasing the overall contour size of the bracket and avoid the stress bending of the limiting rod 21, the wire diameter of the limiting rod 21 is 0.2 mm-0.6 mm. Furthermore, in order to reduce the resistance when the limiting rod 21 is pulled away, the ratio of the area of the first lock catch 231 or the second lock catch 232 to the cross-sectional area of the limiting rod 21 is 1.5-3. It should be noted that, when the first locking device 231 or the second locking device 232 is ring-shaped, "the area of the first locking device 231 or the second locking device 232" refers to the area inside the ring of the first locking device 231 or the second locking device 232; when the first locking device 231 or the second locking device 232 is a line segment with two ends fixed on the tubular main body 11, the "area of the first locking device 231 or the second locking device 232" refers to the area enclosed by the first locking device 231 or the second locking device 232 and the tubular main body 11.

In the embodiment shown in fig. 1 and 2, when the stopper rod 21 is fitted into the locking assembly 23, the constraint line 22 constrains the entire circumference of the lumen stent 100. It is understood that in other embodiments, the constraint line 22 may only circumferentially constrain a partial region of the lumen stent 100 when the stop bar 21 is nested within the locking assembly 23. However, if the range of the constraint area where the constraint line 22 is constrained in the circumferential direction is too small, the degree of compression of the stent in the constraint area in the radial direction is large, and the stent in the constraint area is not fully expanded in the expansion process of the stent, and the stents in other areas adhere to the wall, so that a large groove is formed in the constraint area, the wall adhesion of the stent is poor, and the risk of internal leakage is increased. Therefore, in the present embodiment, when the limiting rod 21 is sleeved in the locking assembly 23, the angle of the constraint area of the constraint line 22 for circumferentially constraining the tubular main body 11 along the circumferential direction is 180 ° to 360 °.

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. 10 and 11, a lumen stent 100 according to a second preferred embodiment of the present application is substantially the same as the lumen stent of the first preferred embodiment, and the lumen stent 100 includes a tubular main body 11 and a semi-releasing device 200 attached to an outer surface of the tubular main body 11. The second embodiment differs from the first embodiment in that the tubular body 11 comprises a first zone 115 and a second zone 116 in the circumferential direction, while the semi-releasing means 200 is arranged within the second zone 116.

When the luminal stent 100 is released from the delivery sheath and in a semi-released state, the first region 115 of the luminal stent 100 is fully deployed, and at this time, the operator can accurately position the first region 115. Moreover, when the half-releasing device 200 is released from the constraint, the constrained portion of the luminal stent 100 is gradually expanded, and the first region 115 has no expansion motion, thereby greatly reducing the circumferential alignment error of the first region 115. Therefore, when the tubular main body 11 is provided with the parts requiring high positioning, such as branches, branch windows, keels, etc., the parts requiring high positioning can be arranged in the first region 115, and only the second region 116 of the lumen stent 100 is circumferentially constrained, thereby improving the positioning accuracy. In the embodiment shown in fig. 10 and 11, a breakout window 30 is disposed within the first region 115.

It can be understood that if the range of the constraint area of the second region 116 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 extent of the constrained region of the second region 116 in the axial direction is too large, then local constraint of the luminal stent 100 is less significant. Therefore, in the present embodiment, when the luminal stent 100 is completely deployed, the circumferential angle covered by the second zone 116 is 180 ° to 340 °.

In order to reduce circumferential and axial positioning deviation and avoid the adherence of the stent during positioning adjustment, the ratio of the diameter of the circumscribed circle of the cross section of the luminal stent 100 in a semi-release state to the diameter of the circumscribed circle of the cross section of the luminal stent 100 in an unfolded state is also 0.6-0.8.

In the embodiment shown in fig. 10 and 11, the binding unit 20 includes a plurality of limit buckles 24 uniformly distributed in a circumferential direction, and the binding line 22 is penetrated through each limit buckle 24. The first locking catch 231 and the second locking catch 232 are both ring-shaped, the first locking catch 231 is disposed at one end of the leash line 22, and the second locking catch 232 is disposed on the tubular main body 11. During assembly, the limiting rod 21 is respectively sleeved in the first lock catch 231 and the second lock catch 232, and after accurate positioning is achieved, the limiting rod 21 is pulled out of the first lock catch 231 and the second lock catch 232 so as to remove constraint.

Since the specific structure of the half release device 200 in the second embodiment is the same as that in the first embodiment, the detailed structure of the half release device 200 is not described herein.

Referring to fig. 12, 13 and 14, a lumen stent 100 according to a third preferred embodiment of the present application is substantially the same as the lumen stent of the first preferred embodiment, and the lumen stent 100 includes a tubular main body 11 and a semi-releasing device 200 attached to an outer surface of the tubular main body 11. The half-releasing device 200 comprises a limiting rod 21 and a plurality of binding units 20 movably connected with the limiting rod 21, wherein the binding units 20 comprise binding lines 22 and locking assemblies 23. The locking assembly 23 includes a first locking catch 231 connected to the leash line 22, and a second locking catch 232 connected to the leash line 22 or/and the tubular body 11, and the limiting rod 21 is movably connected in the first locking catch 231 and the second locking catch 232.

The third embodiment is different from the first embodiment in that the binding thread 22 includes a fixing portion 221 and two binding portions 222 respectively extending from both sides of the fixing portion 221, the fixing portion 221 can be fixed on the tubular body 11 by sewing or bonding, and the locking assemblies 23 are respectively connected to the two binding portions 222. When the stopper rod 21 is fitted in the locker module 23, the constraint line 22 circumferentially constrains the tubular body 11 in the vicinity thereof.

Since the two binding portions 222 of the binding line 22 extend from both sides of the fixing portion 221, respectively, when the constraint of the stopper rod 21 is released, the two binding portions 222 move circumferentially in opposite directions, respectively, i.e., the forces acting on the tubular body 11 by the two binding portions 222, respectively, can be at least partially offset, thereby ensuring smooth deployment of the tubular body 11 during the release of the constraint. Moreover, because the fixing part 221 is fixedly connected to the tubular main body 11, the fixing part 221 has no circumferential movement in the process of removing the constraint, so that the area where the fixing part 221 is located is more stable in unfolding, and the circumferential alignment error of the area is greatly reduced. Therefore, when the tubular body 11 is provided with a member having a high positioning requirement, such as a branch, a branch window, a keel, or the like, the member having a high positioning requirement can be provided in the vicinity of the fixing portion 221, thereby improving the positioning accuracy. In the embodiment shown in fig. 14, the tubular body 11 comprises, in the circumferential direction, a first zone 115 and a second zone 116, the fixing portion 221 being located in the first zone 115, the locking assembly 23 being located in the second zone 116, the first zone 115 being provided with the branch window 30. It will be appreciated that the circumferential angle covered by the first region 115 may be determined according to the specific dimensions of the positioning-critical component, so long as it is ensured that the positioning-critical component is entirely located within the first region 115.

It will be appreciated that since the fixing portion 221 is not moved circumferentially during the process of releasing the constraint, the positioning effect of the branch window 30 is best when the line connecting the geometric center of the branch window 30 and the fixing portion 221 is parallel to the longitudinal central axis of the tubular body 11. It will also be appreciated that when the lengths of the two tie-down portions 222 are equal, the forces respectively exerted by the two tie-down portions 222 on the tubular body 11 can be fully counteracted, ensuring a smooth deployment of the tubular body 11 during the unbounding process. It will also be appreciated that since the tether line 22 is provided with the holding portion 221, the holding portion 221 prevents the tether line 22 from being separated from the stent into the downstream blood vessel when the tether line 22 slides down from all the retainer buckles 24.

Further, the restraint unit 20 further includes at least one limit buckle 24, the limit buckle 24 is fixed to the tubular body 11, and the restraining wire 22 and/or the locking assembly 23 pass through from one side to the other side of the limit buckle 24. In the embodiment shown in fig. 11, a plurality of binding units 20 are uniformly distributed on the outer surface of the tubular body 11, each binding unit 20 being distributed along the circumferential direction. The binding unit 20 includes a plurality of limit buckles 24 uniformly distributed in a circumferential direction, and the binding line 22 is penetrated through each limit buckle 24. The locking assembly 23 includes a first locking device 231 connected to an end of one of the binding portions 222, and two second locking devices 232 respectively connected to an end of the other binding portion 222 and the tubular body 11, wherein the first locking device 231 and the second locking device 232 are both ring-shaped. During assembly, the limiting rod 21 is respectively sleeved in the first lock catch 231 and the two second lock catches 232, and after accurate positioning is achieved, the limiting rod 21 is pulled out of the first lock catch 231 and the second lock catches 232 so as to remove constraint. It is understood that the present embodiment does not limit the specific positions of the first and

second lockers

231 and 232 on the leash line 22, and in other embodiments, the first or

second lockers

231 and 232 may be located in other areas outside the end of the leash line 22.

The present application provides a plurality of position-limiting buckles 24 on the outer surface of the tubular body 11, and allows the lashing line 22 and/or the locking assembly 23 to penetrate through the position-limiting buckles 24. Moreover, the limiting ring 24 can prevent the binding line 22 from being axially displaced when the lumen stent 100 is compressed in the delivery sheath or the binding of the binding line 22 to the lumen stent 100 is released.

The locking clip assembly 23 may also be threaded from one side of the retainer buckle 24 to the other, for example, in the embodiment shown in fig. 3, the first locking clip 231 is a ring structure connected to one end of the lashing line 22, and the first locking clip 231 is sleeved in the retainer buckle 24.

Like the embodiment, the specific structures of the first latch 231 and the second latch 232 are not limited in this embodiment, as long as the limiting rod 21 can be movably connected in the first latch 231 and the second latch 232. For example, in the embodiment shown in fig. 4, the first locking catches 231 are not in a ring structure, and the first locking catches 231 are hooked on the position-limiting ring buckle 24, that is, the first locking catches 231 are passed from one side of the position-limiting ring buckle 24 to the other side and then folded back, and at this time, the leash line 22 and the first locking catches 231 are in an integral structure.

Since the structure, number and fixing position of the position-limiting ring 24, the relationship among the position-limiting ring 24, the binding line 22 and the locking assembly 23, and the relationship among the position-limiting rod 21 and the locking assembly 23 are the same as those in the first embodiment, they are not described again.

In the embodiment shown in fig. 12, 13 and 14, when the stopper rod 21 is fitted into the locking assembly 23, the constraint line 22 constrains the entire circumference of the lumen stent 100. It is understood that in other embodiments, the constraint line 22 may only circumferentially constrain a partial region of the lumen stent 100 when the stop bar 21 is nested within the locking assembly 23. However, if the range of the constraint area of the constraint line 22 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 the stent in the constraint area is not fully expanded in the expansion process of the stent, and the stents in other areas adhere to the wall, so that a large groove is formed in the constraint area, the wall of the stent is not adhered well, and the risk of inner leakage is increased. Therefore, in the present embodiment, when the limiting rod 21 is sleeved in the locking assembly 23, the angle of the constraint area of the constraint line 22 for circumferentially constraining the tubular main body 11 along the circumferential direction is 180 ° to 360 °.

Referring to fig. 15 and 16, a lumen stent 100 according to the fourth embodiment of the present application is substantially the same as the lumen stent of the first embodiment, and the lumen stent 100 includes a tubular main body 11 and a half-releasing device 200 attached to an outer surface of the tubular main body 11. The fourth embodiment differs from the first embodiment in that the luminal stent 100 further comprises two inner branches 12 and two outer branches 13 communicating with the tubular body 11. Referring to fig. 17, the tubular body 11, the inner branch 12 and the outer branch 13 are each a stent graft having a hollow lumen constituting a passage through which blood flows. The stent graft comprises a bare stent 101 and a stent graft 102 connected to the bare stent 101.

Since the structure of the half release device 200 of the fourth embodiment is the same as that of the first embodiment, the detailed structure thereof will not be described herein.

The tubular main body 11 comprises a first main body section 111, a taper section 112 and a second main body section 113 which are connected in sequence, the cross-sectional area of the first main body section 111 is larger than that of the second main body section 113, and the two inner branches 12 and the two outer branches 13 are connected to the taper section 112. Wherein the distal end of the inner branch 12 is fixed on the taper section 112, and the proximal end is located inside the tubular main body 11 and extends towards the side far away from the second main body section 113; the proximal end of the outer branch 13 is fixed to the tapered section 112 and the distal end is located outside the tubular body 11 and extends towards the side remote from the first body section 111.

Referring to fig. 17 and 18, in operation, the first main body section 111 is first attached to the healthy blood vessel wall upstream of the tumor cavity, and the tapered section 112 and the second main body section 113 are retained in the tumor cavity. Subsequently, a guide wire (not shown) is passed from within the inner branch 12 or the outer branch 13 and introduced into the branch vessel near the tumor lumen to establish a trajectory. Then, one end of the extension stent 14 is fitted into the inner branch 12 or the outer branch 13, the other end of the extension stent 14 is positioned in the branch vessel, and the blood flow passing through the tubular body 11 is introduced into the branch vessel through the extension stent 14.

According to the present application, the two inner branches 12 and the two outer branches 13 are connected to the taper section 112, and since the taper section 112 is closer to the first main body section 111 than the second main body section 113, the guiding guidewire has more operating space after penetrating out from the distal end of the inner branch 12 or the outer branch 13, so that the guiding guidewire can be conveniently and accurately introduced into the branch vessel. Moreover, by arranging the two inner branches 12 and the two outer branches 13 on the tapered section 112, the distal ends of the inner branches 12 and the outer branches 13 can be located in different planes, so that the extension stents 14 are arranged in a staggered manner in the tumor cavity, and the extrusion between the extension stents 14 is avoided.

Since the tubular main body 11 is provided with the developing marks (not shown) respectively positioning the inner branch 12 and the outer branch 13, if the inner branch 12 and the outer branch 13 are too close to each other, the developing marks of the inner branch and the outer branch interfere with each other, which is not favorable for guiding the guide wire to select the corresponding branch, thereby affecting the operation and prolonging the operation time. In addition, since the X-ray fluoroscopic image during the operation is a planar image, if the inner branch 12 and the outer branch 13 are spaced too far apart, the outer branch 13 is located at the opposite side of the inner branch 12, and the visualization markers of the inner branch and the outer branch still interfere with each other under the monitoring of the planar image, thereby affecting the operation. Therefore, it is necessary to design the position between the inner branch 12 and the outer branch 13 properly to avoid the interference of the development marks between the four branches and to avoid the defect that the branches are spaced too close to each other to cause the extrusion between the extension brackets 14. In the present application, the two inner branches 12 are located between the two outer branches 13, an included angle a between the adjacent inner branches 12 and the outer branches 13 along the circumferential direction is 60 ° to 80 °, and an included angle b between the two outer branches 13 along the circumferential direction is 170 ° to 180 °.

Referring to fig. 19, the tubular body 11 is provided with four windows 110, two of which are inner branch windows 110a connected to the inner branch 12 and two of which are outer branch windows 110b connected to the outer branch 13, and development marks (not shown) are provided at or near the edges of the four windows 110. It should be noted that a plane passing through the geometric center of the inner branch window 110a and passing through the longitudinal center axis of the tapered section 112 is defined as a first plane m, a plane passing through the geometric center of the outer branch window 110b and passing through the longitudinal center axis of the tapered section 112 is defined as a second plane n, where "an angle a in the circumferential direction between the inner branch 12 and the adjacent outer branch 13" refers to an included angle a between the first plane m and the adjacent second plane n, and "an angle b in the circumferential direction between the two outer branches 13" refers to an included angle b between the two second planes n. It is understood that the present embodiment does not limit the specific structure and the connection position of the developing structure, as long as the positioning of the window 110 can be achieved, for example, the developing structure is an elastic metal ring having a developing function and connected to the circumferential outer edge of the window 110.

In the embodiment shown in fig. 19, the four windows 110 are the same area. It will be appreciated that the area of the four windows 110 may also be different in other embodiments. For example, in the embodiment shown in fig. 20, the area of the inner branch window 110a is larger than the area of the outer branch window 110 b. After the inner branch 12 and the outer branch 13 of the lumen stent are released, because the distal end of the outer branch 13 is a free end, under the impact of blood flow, the distal end of the outer branch 13 will tilt up, even touch the inner wall of the tumor cavity, and stimulate the blood vessel. Because the area of the inner branch window 110a is larger than that of the outer branch window 110b, most blood can rapidly pass through the inner branch 12, so that the blood pressure of the outer branch 13 is reduced, and the far end of the outer branch 13 is prevented from tilting and touching the inner wall of the tumor cavity.

It will be appreciated that it is also possible to fix the middle part of the outer branch 13 to the tubular body 11 in a point-connected manner, in order to avoid the distal end of the outer branch 13 from tilting up and touching the inner wall of the tumor cavity, and at the same time to avoid too little space available for the guide wire to be guided out of the distal end of the outer branch 13.

Referring to fig. 21, a circle of wavy rings 1011 is disposed on the tapered section, and includes a plurality of peaks 1012, a plurality of valleys 1013, and a plurality of connecting rods 1014 connecting adjacent peaks 1012 and valleys 1013, respectively. The wavy ring 1011 supports the surrounding structure, if the proximal end of the outer branch 13 is connected above the trough 1013, the trough 1013 will have an upward supporting force on the proximal end of the outer branch 13, and since the distal end of the outer branch 13 is a free end, the supporting force will make the distal end of the outer branch 13 tilt upward, even touch the inner wall of the tumor cavity; if the proximal end of the outer branch 13 is connected below the peak 1012, the peak 1012 provides a downward supporting force to the lower end of the outer branch 13, so that the longitudinal central axis of the outer branch 13 is substantially parallel to the longitudinal central axis of the tubular body 11, thereby preventing the distal end of the outer branch 13 from tilting outward and touching the inner wall of the tumor cavity. Thus, in this embodiment, the proximal end of outer branch 13 is connected below peak 1012. Also, due to the supporting effect of the wave-shaped ring 1011, if the distal end of the inner branch 12 is connected below the peak 1012, the peak 1012 will limit the upward bending angle of the extension bracket 14 received in the inner branch 12, and when the upward bending angle of the extension bracket 14 is too large, the extension bracket 14 will be folded. Thus, in this embodiment, the distal end of the inner branch 12 is attached above the trough 1013 to facilitate the attachment of the elongate stent 14.

Further, at least one peak 1012 and one valley 1013 are provided between adjacent inner branch windows 110a and outer branch windows 110b to ensure that the proximal end of the outer branch 13 is connected below the peak 1012 and the distal end of the inner branch 12 is connected above the valley 1013. Preferably, only one peak 1012 and one trough 1013 are disposed between adjacent inner branch windows 110a and outer branch windows 110b to reduce the overall sheath-mounting volume of the luminal stent.

Referring again to fig. 18, since there are more extension brackets 14, in order to avoid interference between the extension brackets 14, the adjacent inner branch 12 and the extension bracket 14 on the outer branch 13 are usually bent toward one side, and the other two adjacent inner branches 12 and the extension brackets 14 on the outer branch 13 are bent toward the other side. That is, the adjacent inner branch 12 and the extension bracket 14 fitted to the outer branch 13 easily interfere with each other, and the angle a in the circumferential direction of the adjacent inner and outer branches needs to be increased. It will be appreciated that if the angle of adjacent inner and outer branches in the circumferential direction is to be increased, the angle between the two inner branches 12 in the circumferential direction is to be decreased, provided that the arrangement of the inner and outer branches meets the above-mentioned angular requirements.

In the embodiment shown in fig. 21, a peak 1012 is disposed between the two inner branch windows 110 a. The peaks 1012 not only support the inner branch windows 110a to avoid distal depression of the inner branch, but also ensure that both inner branch windows 110a are located above the valleys 1013. Further, in order to avoid the two inner branch windows 110a being too far apart, the included angle α of the wave of the peak 1012 is 0 to 10 °. It should be noted that the "wave angle α" herein refers to an angle between the connecting rods 1014 connected to both sides of the wave peak 1012, and when the wave angle is 0, the connecting rods 1014 on both sides of the wave peak 1012 are arranged in parallel. If the fillet radius r at the peak 1012 or the trough 1013 is too large, the stent is not easily compressed, and the overall sheath-mounting volume of the stent is affected, but the fillet radius r is too small, and the stimulation of the peak 1012 or the trough 1013 to the blood vessel becomes large. Therefore, the fillet radius r of the wave-shaped ring 1011 on the taper section 112 at the wave crest 1012 or/and the wave trough 1013 is 0.5 mm-1.5 mm.

Referring to fig. 22, the distal end of each inner branch 12 is fixed to the inner branch window 110a, and the proximal end extends to a side away from the second body segment 113, so that in order to avoid the inner branch 12 swinging under the impact of blood flow, the inner branch 12 can be fixed to the tubular body 11, so as to facilitate the guide wire to be inserted into the corresponding inner branch 12.

Due to the distance between the two inner branch windows 110a, a gap is formed between the outer wall of the two inner branches 12 and the inner wall of the tubular body 11, which is liable to cause thrombus formation. Therefore, in order to avoid thrombus to move to the downstream blood vessel along the gap, the outer walls of the distal ends of the two inner branches 12 are connected with the inner wall of the tubular main body 11 in a closed manner, i.e. there is no gap between the outer walls of the distal ends of the two inner branches 12 and the inner wall of the tubular main body 11. Specifically, the distal ends of the two inner branches 12 may be fixed together by means of suturing, and then the distal ends of the two inner branches 12 are fixed to the inner wall of the tubular body 11. Further, to avoid thrombosis, the entire outer wall of the two inner branches 12 is hermetically connected to the tubular body 11.

In the embodiment shown in fig. 23, the two inner branches 12 have different heights, and the corrugated loops 1011 on the two inner branches 12 are offset to reduce the overall sheath volume of the first body section 111. And, at least one support rod 1015 is provided on the inner branch 12 to increase an axial support force of the inner branch 12. The two ends of the support rod 1015 may be connected to two adjacent rings 1011, respectively, and the support rod 1015 may be parallel to the longitudinal central axis of the inner branch 12 or may be disposed obliquely to the longitudinal central axis of the inner branch 12. Preferably, the support rod 1015, the longitudinal central axis of the inner branch 12 and the longitudinal central axis of the first body section 111 are coplanar, and the support rod 1015 has the best axial support effect. In the embodiment shown in fig. 24, the support rod 1015 extends to the distal end of the inner branch 12 to prevent collapse of the coating region at the distal end of the inner branch 12, thereby facilitating the insertion of a guide wire into the inner branch 12 and the extension of the stent connection.

Referring to fig. 25, for the convenience of guiding the guide wire into the inner branch 12, the proximal end surface of the inner branch 12 is disposed obliquely to the longitudinal central axis of the inner branch 12. It will be appreciated that the smaller the angle β between the proximal end face of the inner branch 12 and its longitudinal central axis, the more advantageous the guide wire can be selected into the inner branch 12, but too small an angle β will affect the strength of the connection of the elongate stent to the inner branch 12. Therefore, in the present embodiment, the angle β between the proximal end surface of the inner branch 12 and the longitudinal central axis of the inner branch 12 is 30 ° to 60 °. Preferably, the lowest point of the proximal end surface of the inner branch 12 is located in the plane formed by the longitudinal central axis of the inner branch 12 and the longitudinal central axis of the first body segment 111, where the guide wire is most advantageously selected.

Referring to fig. 26, the vertical distance j between the highest point of the proximal end surface of the inner branch 12 and the proximal end of the first body section 111 is not less than 20 mm. At this time, when the proximal end of the first body segment 111 needs to be sleeved with another stent (not shown), the distance between the highest point of the proximal end surface of the inner branch 12 and the proximal end of the first body segment 111 can provide a sufficient anchoring area for the sleeved other stent to avoid the interference between the sleeved other stent and the inner branch 12.

Further, the outer wall of the first body segment 111 is provided with a barb structure 1016 to enhance the overall anchoring performance of the tubular stent. When another stent is externally sleeved on the proximal end of the first body segment 111, if the barb structure 1016 is too close to the proximal end of the first body segment 111, the barb structure 1016 may easily pierce the sleeved other stent to form an inner leak, but if the barb structure 1016 is too close to the inner branch 12, the flexibility of the lumen stent as a whole may be affected. Thus, barb structure 1016 is fixed to the outer wall of first body segment 111 and is located between the proximal end of inner branch 12 and the proximal end of first body segment 111. In the embodiment shown in fig. 10, barb structures 1016 are disposed on undulating ring 1011 of first body section 111 such that the highest point of the proximal end surface of inner branch 12 is located a vertical distance k of 5mm to 15mm from barb structures 1016.

Referring to fig. 27, the proximal end of the outer branch 13 is fixed to the outer branch window, and the other end extends away from the first body segment 111. Since the inner and outer branches are disposed on the tapered section 112, in order to reduce the sheath volume of the tapered section 112, in the present embodiment, the distal end wavy ring 1011b of the inner branch 12 is located above the proximal end wavy ring 1011a of the outer branch 13, that is, the vertical distance h between the peak of the proximal end wavy ring 1011a of the outer branch 13 and the valley of the distal end wavy ring 1011b of the inner branch 12 is greater than or equal to 0. However, when the value of h is too large, the distance between the distal end corrugated loop 1011b and the distal end of the inner branch 12 is too far, or the distance between the proximal end corrugated loop 1011a and the proximal end of the outer branch 13 is too far, which may easily cause the distal end of the inner branch 12 or the proximal end of the outer branch 13 to collapse. Therefore, the h value is not more than 15 mm.

In the embodiment shown in fig. 28, the distal end of the inner branch 12 is located above the distal end of the outer branch 13, i.e. the vertical distance c between the highest point on the distal end surface of the outer branch 13 and the lowest point on the distal end surface of the inner branch 12 is larger than 0, to ensure that the outer branch 13 is still inside the delivery sheath when the distal end of the inner branch 12 has just been released from the delivery sheath. Because the in-process of releasing the support, the blood flow pressure that the support received is great, is unfavorable for pinpointing the support, just releases from carrying the sheath pipe when the distal end of interior branch 12, and outer branch 13 still is in when carrying the sheath pipe, and the blood flow can pass through in interior branch 12 fast to reduce the blood flow and to the impact of support system, not only be convenient for fix a position interior branch 12, can also make subsequent release process more stable. It will be appreciated that if the value of c is too small, the inner branch 12 and the outer branch 13 are easily released simultaneously during the operation, which is not favorable for positioning the stent. In addition, if the value c is too large, the length of the outer branch 13 is too long, which may cause the insufficient operation space after the guide wire passes through the distal end of the outer branch 13, and the guide wire may not be accurately introduced into the branch vessel, thereby increasing the operation time. Therefore, the above c value is not less than 5mm and not more than 12 mm.

Further, the distal end surface of the outer branch 13 is disposed obliquely to the longitudinal center axis of the outer branch 13. It can be understood that the smaller the angle between the distal end surface of the outer branch 13 and the longitudinal central axis thereof, the more the guiding wire has to be deployed from the distal end of the outer branch 13 to facilitate the accurate introduction of the guiding wire into the branch vessel, but the smaller the angle is, the more the connection strength of the stent and the outer branch 13 is affected. Therefore, in the present embodiment, the included angle between the distal end surface of the outer branch 13 and the longitudinal central axis of the outer branch 13 is 30 ° to 60 °.

In the embodiment shown in fig. 29, the distal end of the inner branch 12 is located above the proximal end of the outer branch 13, i.e. the vertical distance d between the highest point on the proximal end surface of the outer branch 13 and the lowest point on the distal end surface of the inner branch 12 is larger than 0, to ensure that the outer branch 13 is still inside the delivery sheath when the distal end of the inner branch 12 has just been released from the delivery sheath. Because the in-process of releasing the support, the blood flow pressure that the support received is great, is unfavorable for pinpointing the support, just releases from carrying the sheath pipe when the distal end of interior branch 12, and outer branch 13 still is in when carrying the sheath pipe, and the blood flow can pass through in interior branch 12 fast to reduce the blood flow and to the impact of support system, not only be convenient for fix a position interior branch 12, can also make subsequent release process more stable. However, if the value d is too large, the length of the outer branch 13 is too long, and the guide wire may not be accurately introduced into the branch vessel due to insufficient operation space after the guide wire passes through the distal end of the outer branch 13, thereby increasing the operation time. Therefore, the above d value is not more than 10 mm.

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. An implant, comprising a tubular main body and a semi-releasing device connected to the outer surface of the tubular main body, wherein the semi-releasing device comprises a limiting rod and a binding unit movably connected with the limiting rod, the binding unit comprises a binding line, a locking assembly and at least one limiting buckle, the locking assembly is connected to the binding line, the limiting buckle is fixed on the tubular main body, the binding line and/or the locking assembly are/is threaded from one side to the other side of the limiting buckle, when the limiting rod is threaded in the locking assembly, the binding line circumferentially restrains the tubular main body, the tubular main body comprises a first area and a second area along the circumferential direction, the semi-releasing device is positioned in the second area, and a branch window is arranged in the first area;

the lock catch assembly comprises a first lock catch connected to the constraint line and a second lock catch connected to the tubular main body, and the limiting rod is movably connected to the first lock catch and the second lock catch.

2. The implant of claim 1, wherein the tubular body comprises a plurality of turns of a wave ring, and a covering membrane connected to the wave ring, the wave 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;

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

3. The implant of claim 2, wherein the fixation points of the stop collar are disposed on the wave ring.

4. The implant of claim 3, wherein the fixation point of the stop collar is located in the middle of the connecting rod.

5. The implant of claim 1, wherein the constraint zone circumferentially constraining the tubular body by the constraint line is circumferentially angled 180 ° -360 °.

6. The implant of claim 1, wherein the ratio of the circumscribed circle diameter of the cross-section of the tubular body in the semi-released state to the circumscribed circle diameter of the cross-section of the tubular body when fully deployed is 0.6 to 0.8.

7. The implant of claim 1, wherein an anti-slip feature is provided between the locking assembly and the stop collar.

8. The implant of claim 7, wherein the anti-slip structure is a retainer provided on the leash line, the retainer having an outer diameter greater than an inner diameter of the stop buckle.

9. The implant of claim 1, wherein the number of the stop buckles is plural, and the plural stop buckles are distributed along a circumferential direction.