CN112891017B

CN112891017B - Lumen stent

Info

Publication number: CN112891017B
Application number: CN201911222561.5A
Authority: CN
Inventors: 肖本好; 唐春炜
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-03
Filing date: 2019-12-03
Publication date: 2023-06-02
Anticipated expiration: 2039-12-03
Also published as: CN112891017A

Abstract

The invention discloses a lumen stent, which comprises a tubular main body and a half release device, wherein the half release device comprises a limiting rod positioned in the tubular main body and a circular binding wire wound on the inner surface of the tubular main body, at least two locking parts are arranged on the binding wire, the at least two locking parts are of semicircular ring structures formed by folding one binding wire in half 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 limiting rod is separated from the tubular main body, and the binding wire circumferentially constrains the tubular main body. The invention has the beneficial effects that: this application sets up half release structure in the lumen support, makes the surface of lumen support smooth, even the lumen support touches the vascular wall when the 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, makes things convenient for the position of lumen support to adjust.

Description

Lumen stent

Technical Field

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

Background

Over ten years ago, aortic stent graft endoluminal isolation has been widely applied to lesions such as aneurysms and aortic dissection of the thoracic and abdominal aorta, has definite efficacy, small trauma, quick recovery and fewer complications, and has become a first-line treatment method. During operation, under X-ray perspective monitoring, the covered stent is sent to the lesion position through the corresponding conveying system, the covered stent isolates blood flow from the lesion position, and the influence of blood pressure on the lesion 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 key positions of the stent graft, and the axial direction and the circumferential direction of the stent graft are positioned by using the development marks. However, when the stent graft is compressed in the delivery sheath, the stent graft has compression folds in the circumferential direction and is in an elongated state in the axial direction, and if the stent graft is positioned by the development mark at this time, there is a large circumferential and axial deviation.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a lumen stent aiming at the defects in the prior art.

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

the utility model provides a lumen support, including the tubular main part, and connect half release on the tubular main part, half release is including being located the gag lever post in the tubular main part, and twine the constraint line of tubular main part internal surface, be provided with two at least locking parts on the constraint line, two at least locking parts be a semicircle ring structure that the constraint line fifty percent discount formed and with separable mode with the gag lever post is connected, when two at least locking parts with the gag lever post is connected, there is the clearance between gag lever post and the tubular main part, the constraint line sets up the part on the tubular main part is for having the ring form of two at least breach, the breach with the locking part quantity equals, and every the breach with every locking part one-to-one, the constraint line is right the tubular main part carries out the circumference constraint.

In the lumen stent of the present invention, a restraint channel is provided on the inner surface of the tubular body, the restraint wire is positioned in the restraint channel, and the locking part penetrates out of the restraint channel and is connected with the limit rod.

In the lumen stent of the present invention, a membrane is provided on the inner surface of the tubular body, the binding channel is formed between the membrane and the covering membrane, a wire hole communicating with the lumen of the binding channel is provided on the membrane, and the binding wire passes through the wire hole.

In the lumen stent of the present invention, the inner surface of the tubular main body is provided with a plurality of limit buckles, the restraint channel is composed of the plurality of limit buckles, and the restraint line is penetrated from the limit buckles.

In the lumen stent of the present invention, the tubular body comprises a multi-turn wave ring, the wave ring 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;

the number of the limiting ring buckles is multiple, in a natural state, the straight line distance between every two adjacent limiting ring buckles is e, and the vertical distance between a fixed point of each limiting ring buckle and a trough which is positioned below each limiting ring buckle and closest to each limiting ring buckle is f, wherein e and f are smaller than or equal to 2f.

In the lumen stent of the present invention, the number of the limit rods is at least two.

In the lumen stent of the present invention, the binding wire is provided with a fixing portion, and the binding wire is fixedly connected with the tubular body through the fixing portion.

In the lumen stent of the present invention, the ratio of the diameter of the circumscribed circle of the cross section of the lumen stent in the half-release state to the diameter of the circumscribed circle of the cross section of the lumen stent when fully deployed is 0.6 to 0.8.

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

Drawings

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

FIG. 1 is a schematic illustration of a luminal stent provided by one of the embodiments of the present invention in a semi-released state;

FIG. 2 is a top view of the lumen stent of FIG. 1;

FIG. 3 is an enlarged view of portion A of the lumen stent of FIG. 1;

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

FIG. 5 is a top view of the lumen stent of FIG. 4;

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

FIG. 7 is a schematic view of the constrained channel of the lumen stent of FIG. 1 as comprised of a plurality of stop collars;

FIG. 8 is a schematic view of the lumen stent of FIG. 7 with the binding wires passing over the valleys;

FIG. 9 is a schematic illustration of the lumen stent of FIG. 7 with the binding wires not passing over the valleys;

FIG. 10 is a schematic view of the constrained 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 when fully deployed;

FIG. 12 is a schematic illustration of a lumen stent according to a second embodiment of the present invention in a semi-released state;

FIG. 13 is a schematic illustration of the luminal stent of FIG. 12 after primary constraint is released;

FIG. 14 is a schematic view of the luminal stent of FIG. 12 after secondary restraint has been released;

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

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

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

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the invention, which is therefore not limited to the specific embodiments disclosed below.

It will be understood that when an element is referred to as being "fixed" 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 are used herein for illustrative purposes only and are not meant to be the only embodiment.

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

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

Referring to fig. 1, one of the embodiments of the present application provides a luminal stent 100 comprising a bare stent and a cover 102 attached to the bare stent. The lumen stent 100 is a hollow lumen structure, and the lumen of the lumen stent 100 constitutes a channel 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 coating 102 is made of a polymer material with good biocompatibility, such as PTFE, FEP, PET. The bare stent comprises a plurality of rings of wavy rings 101 (as shown in fig. 7), each ring of wavy rings 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 rings of wavy rings 101 are sequentially distributed from the proximal end to the distal end, preferably at parallel intervals. The wavy annular objects 101 are in a closed cylindrical structure, and the wavy annular objects 101 can have the same or similar wavy shape, and it is understood that the embodiment is not limited to the specific structure of the wavy annular objects 101, the wavy annular objects 101 can be arranged according to the requirement, and the number of the wavy annular objects 101 and the height of the wavy annular objects can be arranged according to the requirement.

Referring to fig. 1, the lumen stent 100 includes a tubular body 11 and a half-release device 20 coupled to the tubular body 11 for circumferentially constraining the tubular body 11. The half-release device 20 comprises a stop bar 21 located inside the tubular body 11, and a binding wire 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 channel 110, the restraint line 22 is located in the restraint channel 110, and at least two locking portions 221 are provided on the restraint line 22. The restraint passage 110 is provided with at least two wire holes 111, and the restraint wire 22 passes through the wire holes 111 into the inside of the tubular body 11 and detachably connects the at least two locking portions 221 with the stopper rod 21. When the stopper rod 21 is connected to the locking portion 221, the tie-down line 22 circumferentially restrains the tubular body 11. Referring to fig. 4 and 5, when the stopper rod 21 is separated from the locking portion 221, the restriction of the stopper rod 21 to the locking portion 221 is released, and the restriction line 22 moves from the line hole 111 into the restriction passage 110 under the radial supporting force of the tubular body 11 until the tubular body 11 is fully unfolded.

According to the method, the semi-release device 20 is arranged on the lumen stent 100, after the lumen stent 100 is released from the delivery sheath, the lumen stent 100 is in a semi-release state under the constraint of the semi-release device 20, at this time, the lumen stent 100 is not attached to the wall of a blood vessel, an operator can still adjust the axial and circumferential positions of the lumen stent 100, after the positioning is accurate, the constraint of the semi-release device 20 is released, and the lumen stent 100 is unfolded and attached.

However, when the lumen stent 100 is in the semi-released state, the axial and circumferential positions of the lumen stent 100 are easily touched by the operator, and particularly in the case of bending of a blood vessel, the lumen stent 100 inevitably touches the blood vessel wall when the position of the lumen stent 100 is adjusted. This application sets up half release structure 20 in lumen stent 100, makes the surface of lumen stent 100 smooth, even lumen stent 100 touches the vascular wall, also can not cause the harm to the vascular wall to smooth surface can reduce the frictional resistance between lumen stent 100 and the vascular wall, makes things convenient for the position of lumen stent 100 to adjust.

Further, the limiting rod 21 is located in the lumen stent 100, so that the limiting rod 21 can be prevented from damaging blood vessels in the positioning and adjusting process of the lumen stent 100, the risk that the end part of the limiting rod 21 touches the blood vessels to bend is reduced, the adjusting space between the lumen stent 100 and the blood vessel wall is not occupied, and the adjusting and positioning of the lumen stent 100 is facilitated especially for the condition of complex structure in the lumen.

It can be appreciated that if the lumen stent 100 is in the semi-released state, the diameter of the circumcircle of the cross section is too large, the lumen stent 100 is easy to adhere, and the axial and circumferential adjustment is not facilitated; if the cross-sectional circumcircle diameter of the luminal stent 100 is too small when in the semi-released state, the semi-release effect is not large and there is still a large circumferential and axial positioning bias. Therefore, in the present embodiment, the ratio of the circumscribed circle diameter of the cross section of the lumen stent 100 in the semi-released state to the circumscribed circle diameter of the cross section of the lumen stent 100 when deployed is 0.6 to 0.8.

In the embodiment shown in fig. 1 to 6, the inner surface of the tubular body 11 is provided with membranes 12 distributed in the circumferential direction, and a tie-down passage 110 is formed between the membranes 12 and the cover film 102, and the tie-down wire 22 is movably located in the tie-down passage 110. At least two wire holes 111 are provided in the membrane 12, the wire holes 111 are in communication with the lumen of the restraint channel 110, and the locking portions 221 of the restraint wires 22 enter the interior of the tubular body 11 through the wire holes 111 and are detachably connected to the stopper rod 21. The locking portion 221 is preferably a ring structure or a semicircular ring structure formed by folding a binding wire 22 in half, and the limit rod 21 can be penetrated from the ring structure or the semicircular ring structure.

The constraining passages 110 may include a plurality of constraining passages 110 axially spaced apart on the inner surface of the tubular body 11, and each constraining passage 110 has a circular ring shape. Each binding channel 110 is internally wrapped with a binding thread 22, and the binding thread 22 wrapped therein is also circular. The tie-down line 22 may be a flexible line with high stretch resistance, such as a polyester suture or the like. The binder thread 22 may be composed of a single flexible thread or may be composed of a plurality of flexible threads.

It should be understood that, although the restraint channel 110 of the present embodiment is formed between the membrane 12 and the covering membrane 102, the present embodiment is not limited to a specific forming manner of the restraint 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 stop collars 23, the restraint channel 110 is composed of a plurality of stop collars 23, and the restraint line 22 is in a ring shape and penetrates through the stop collars 23.

Referring to fig. 7 and 8, if the spacing between the two retaining tabs 23 is too long, when the lumen stent 100 is in a completely radially compressed state in the sheath, the binding wire 22 is in a loose state, and the binding wire 22 between the two retaining tabs 23 is axially displaced, even passes over the trough of the wavy ring 101 and hooks on the trough. When the luminal stent 100 is fully released from the delivery sheath, the binding wire 22 hooks onto the wavy loop 101, resulting in an inability of the luminal stent 100 to properly deploy.

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

Preferably, the limiting ring 23 is located at the middle of the connecting rod of the waveform ring 101, which is not only beneficial to radial compression of the binding wire 22 to the tube cavity bracket 100, so that the waveform ring 101 is uniformly stressed, but also can reduce the risk of damage of the binding wire 22 to the coating.

Preferably, the wavy annulus 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 is convenient to adjust.

It will also be appreciated that the present embodiment does not limit the number of wire holes 111 in the restraint channel 110, for example, in the embodiment shown in fig. 10 and 11, three wire holes 111 are provided in the restraint channel 110, three locking portions 221 are provided in the restraint wire 22, and the restraint wire 22 enters the inside of the tubular body 11 through the wire holes 111 and detachably connects the three locking portions 221 with the stopper rod 21. By providing a plurality of locking portions 221 and wire holes 111, when the stop rod 21 is separated from the locking portions 221, the restraint wire 22 can move from the plurality of wire holes 111 into the restraint channel 110, so that the lumen stent 100 can be deployed and attached more quickly.

It will be appreciated by those of ordinary skill in the art that the luminal stent of the present embodiment is provided by way of example only and not by way of limitation, and the implant of the present application may be any stent graft lumen with a bare stent, including but not limited to a thoracic aortic stent, an abdominal aortic stent, a thoracic abdominal aortic stent, etc.

Referring to fig. 12, 13 and 14, a lumen stent 100 is provided in a second embodiment of the present application, which is substantially the same as the lumen stent of the first embodiment, and the lumen stent 100 includes a tubular body 11 and a half release device 20 connected to each other, wherein the half release device 20 includes a stopper rod 21 disposed in the tubular body 11, and a binding wire 22 wound around an inner surface of the tubular body 11, the inner surface of the tubular body 11 is provided with a binding channel 110, and the binding wire 22 is disposed in the binding channel 110.

The second embodiment is different from the first embodiment in that the stopper rod 21 includes two, a first stopper rod 21a and a second stopper rod 21b, respectively. Four wire holes 111 are provided in the restraint passage 110, four locking portions 221 are provided in the restraint wire 22, two locking portions 221 of the four locking portions 221 are detachably connected to the first stopper rod 21a, and the other two locking portions 221 of the four locking portions 221 are detachably connected to the second stopper rod 21b.

In this embodiment, by providing at least two limiting rods 21, the semi-release function of the lumen stent 100 can be adjusted in a grading manner, and after the primary positioning is accurate, the primary constraint is released, and then the secondary positioning is performed, so that the secondary constraint is released. Fig. 12 is a schematic view of the lumen stent 100 in a half-released state after being released from the delivery sheath, in which two stop rods 21 are respectively connected to four locking portions 221. Fig. 13 is a schematic view of the lumen stent 100 after the primary constraint is released, in which only one stop bar 21 is connected to two locking portions 221. Fig. 14 is a schematic view of the lumen stent 100 after the secondary constraint is released, in which the two stopper rods 21 are separated from the four locking portions 221, and the lumen stent 100 is fully deployed.

Referring to fig. 15 and 16, a third embodiment of the present application provides a lumen stent 100, which is substantially the same as the lumen stent of the first embodiment, wherein the lumen stent 100 comprises a tubular body 11 and a half release device 20 connected to each other, the half release device 20 comprises a stop rod 21 located in the tubular body 11, and a binding wire 22 wound around an inner surface of the tubular body 11, the inner surface of the tubular body 11 is provided with a binding channel 110, and the binding wire 22 is located in the binding channel 110.

The third embodiment differs from one of the embodiments in that the binding line 22 locally binds the tubular body 11, the tubular body 11 comprising a first region 11a and a second region 11b distributed in the circumferential direction, the binding line 22 being arranged on the second region 11 b.

In the embodiment shown in fig. 15 and 16, the tether line 22 is positioned in the second region 11b with two fixing portions 24 provided on the tether line 22, and the tether line 22 is fixed in the tether line 110 by the fixing portions 221, so that the tether line 22 is prevented from being separated from the tether line 110 and entering the downstream blood vessel. The restraint passage 110 is provided with at least two wire holes 111, the restraint wire 22 is provided with at least two locking portions 221, and the restraint wire 22 enters the inside of the tubular body 11 through the wire holes 111 and connects the at least two locking portions 221 with the stopper rod 21 in a separable manner.

When the luminal stent 100 is released from the delivery sheath and in the semi-released state, the first region 11a of the luminal stent 100 has been fully deployed, at which time the operator can accurately position the first region 11 a. In addition, after the restraint of the restraint line 22 is released, in the process that the restraint part (the second region 11 b) of the lumen stent 100 is gradually unfolded, the first region 11a does not have unfolding motion, so that the circumferential alignment error of the first region 11a is greatly reduced. Therefore, when the tubular body 11 is provided with components having high positioning requirements, such as branches, branch windows, keels, etc., these components having high positioning requirements can be provided in the first region 11a, and only the second region 11b of the tubular stent 100 can be circumferentially restrained, thereby improving positioning accuracy.

It will be appreciated that if the extent of the constraint area of the second region 11b in the circumferential direction is too small, the extent of compression of the stent in the radial direction in the constraint area will be relatively large, and in the expansion process of the stent, the stent in the constraint area will not be fully expanded, and the defects that the stent in other regions is adhered to the wall will occur, so that a relatively large groove exists in the constraint area, and the overall adhesion of the stent is poor, thereby increasing the risk of internal leakage. However, if the extent of the restriction area of the second region 11b in the axial direction is too large, the meaning of locally restricting the lumen stent 100 is not great. Thus, in this embodiment, the second region 11b covers a circumferential angle of 180 ° to 340 ° after the luminal stent 100 is fully deployed.

Referring to fig. 17, a fourth embodiment of the present application provides a lumen stent 100, which is substantially the same as the lumen stent of one of the embodiments, wherein the lumen stent 100 comprises a tubular body 11 and a half-releasing device 20 connected together, the half-releasing device 20 comprises a stop rod 21 located in the tubular body 11, and a binding wire 22 wound around an inner surface of the tubular body 11, the inner surface of the tubular body 11 is provided with a binding channel 110, and the binding wire 22 is located in the binding channel 110.

The fourth embodiment differs from one of the embodiments in that the restraining channels are spirally 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 binding channel, and the binding line 22 is penetrated from the limit buckles 23. Two locking portions 221 are provided at both ends of the binding wire 22, and the two locking portions 221 are detachably connected to the stopper rod 21.

Since the binding wires 22 are spirally wound around the inner surface of the tubular body 11, the present embodiment can achieve uniform compression of the entire lumen stent 100 by one binding wire 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 binding wire 22, so that the binding wire 22 can be better compressed uniformly on the spiral of the tubular support 100.

The binding wire 22 further comprises at least one fixing portion 24, the binding wire 22 is fixed on the tubular main body 11 through the fixing portion 221, and when the binding wire 22 slides from all the limiting buckles 24, the fixing portion 221 can prevent the binding wire 22 from being separated from the lumen stent 100 and entering the downstream blood vessel.

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

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

Claims

1. The lumen stent comprises a tubular main body and a half release device connected to the tubular main body, and is characterized in that the half release device comprises a limiting rod positioned in the tubular main body and a binding wire wound on the inner surface of the tubular main body, wherein at least two locking parts are arranged on the binding wire, and the at least two locking parts are of a semicircular ring structure formed by folding one binding wire in half and are connected with the limiting rod in a separable manner; when the at least two locking parts are connected with the limiting rod, a gap exists between the limiting rod and the tubular main body, the part of the binding line arranged on the tubular main body is in a ring shape with at least two notches, the number of the notches is equal to that of the locking parts, each notch corresponds to each locking part one by one, and the binding line is circumferentially constrained on the tubular main body.

2. The lumen stent of claim 1, wherein the inner surface of the tubular body is provided with a restraining channel, the restraining wire being located within the restraining channel, the locking portion passing out of the restraining channel for connection with the stop bar.

3. The lumen stent of claim 2, wherein the inner surface of the tubular body is provided with a membrane, the constraining channel is formed between the membrane and the covering membrane, a wire hole is provided on the membrane in communication with the lumen of the constraining channel, and the constraining wire passes through the wire hole.

4. The lumen stent of claim 2, wherein the inner surface of the tubular body is provided with a plurality of retainer tabs, the tie down channel is comprised of the plurality of retainer tabs, and the tie down wire is threaded from the retainer tabs.

5. The luminal stent of claim 4, wherein the tubular body comprises a multi-turn wavy annulus comprising a plurality of peaks, a plurality of valleys and a plurality of connecting bars connecting adjacent ones of the peaks and valleys, respectively;

6. The luminal stent of claim 1, wherein the number of stop bars is at least two.

7. The lumen stent of claim 1, wherein the binding wire is provided with a fixing portion, and the binding wire is fixedly connected with the tubular body through the fixing portion.

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