Luminal stent

Abstract

The present invention discloses a lumen stent, which comprises a tubular stent and a radiopaque marker. The tubular stent includes a main stent, and the radiopaque marker includes a first marker disposed on the main stent. Among them, the shape of the first marker disposed on the main stent is at least asymmetric along the longitudinal axis. In the present invention, a radiopaque marker with a non-axisymmetric shape is provided on the main stent. Through this radiopaque marker, the position and orientation of the lumen stent implanted in the body can be accurately and clearly displayed, facilitating the operator to observe, quickly judge and adjust in time, thereby shortening the operation time of the endovascular treatment and reducing the operation difficulty.

Description

Technical Field

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

[0002] In the past ten years or more, endovascular exclusion of aortic tubular stents has been widely used in the treatment of diseases such as aneurysms and aortic dissections of the thoracic and abdominal aorta. Its curative effect is definite, the trauma is small, the recovery is fast, and the complications are few. It has become the first-line treatment method. During the operation, under the fluoroscopic monitoring of X-rays, the tubular stent is sent to the lesion site through a corresponding delivery system. The tubular stent isolates the blood flow from the lesion site, eliminates the influence of blood pressure on the lesion site, and achieves the purpose of cure.

[0003] How to accurately position the stent in the body is one of the key conditions for the success of endovascular treatment surgery. Common lumen stents set imaging materials at the stent membrane-covered ports as positioning indicators. For endovascular treatment of arterial diseases where the lesion involves branch vessels, the lumen stent is usually designed with branches / windows. For the lumen stent with branches / windows, how to quickly and accurately position it in the cavity is even more important. The existing positioning methods for stents with branches / windows, such as the imaging markers of the t-Branch stent of COOK Company, as Figure 1 shown, it uses "·"-shaped imaging markers at the proximal and distal ends of the membrane and the ports of the four outer branches. The problems of such imaging markers are that the number of markers is large and it is not easy to distinguish different characteristic imaging markers. It is difficult to judge during the operation. And because the imaging markers are presented under the DSA digital imaging device, the "·"-shaped design of COOK Company will present the same "·"-shaped imaging form whether the stent is placed face up or face down during the imaging process. This leads to the operator being unable to distinguish the front and back positions in the circumferential direction of the stent. If the front and back positioning is found to be incorrect after the lumen stent is released during the operation, it will lead to the failure of the endovascular treatment surgery. The lumen stent placed in the wrong position will affect the normal blood supply of the patient's blood vessels, and the stent can only be removed emergently through surgery, and the patient faces serious life-threatening risks. Summary of the Invention

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

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

[0006] Provide a lumen stent, including a tubular stent and imaging markers. The tubular stent includes a main stent. The imaging markers include a first marker provided on the main stent. Among them, the shape of the first marker provided on the main stent is at least asymmetric along the longitudinal axis.

[0007] In one embodiment, the main body stent includes opposite front half and rear half portions, the first mark is provided on the front half portion or the rear half portion, and the orthographic projection of the first mark on the plane where the front half portion intersects the rear half portion is approximately the same as its own shape.

[0008] In one embodiment, the shape of the first mark is non-axisymmetric.

[0009] In one embodiment, the tubular stent further includes a branch stent, the branch stent has opposite distal openings and proximal openings, and one of the distal opening and the proximal opening is connected to the side wall of the main body stent, so that the lumen of the branch stent is communicated with the lumen of the main body stent; wherein, the first mark is located on the main body stent at the end of the distal opening of the branch stent.

[0010] In one embodiment, the developing mark further includes an annular mark provided at or near the edge of the distal opening and / or the proximal opening of the branch stent.

[0011] In one embodiment, the distal opening and / or the proximal opening of the branch stent are inclined relative to the longitudinal central axis of the branch stent, so that the annular mark is also inclined relative to the longitudinal central axis of the branch stent.

[0012] In one embodiment, the main body stent includes opposite main proximal openings and main distal openings, and the developing mark further includes a second mark provided adjacent to the main proximal opening.

[0013] In one embodiment, the developing mark further includes a third mark provided adjacent to the main proximal opening, the shapes of the second mark and the third mark are different, the second mark and the third mark are arranged at intervals along the circumferential direction of the main body stent, and the radial connection line of the second mark and the third mark passes through the longitudinal central axis of the main body stent.

[0014] In one embodiment, the radial connection line of the first mark and the longitudinal central axis of the main body stent is perpendicular to the radial connection line of the second mark and the third mark.

[0015] In one embodiment, the main body stent further includes a fourth mark provided adjacent to the main distal opening.

[0016] In one embodiment, the fourth mark and the first mark are located on the same longitudinal line.

[0017] In one embodiment, the developing mark further includes a fifth mark disposed on the main body bracket and at a preset distance from the main distal opening, where the preset distance is not less than 20 mm.

[0018] In one embodiment, the fifth mark and the first mark are located on the same longitudinal straight line.

[0019] In summary, the present invention provides a developing mark with a non-axisymmetric shape on the main body bracket. Through this developing mark, the position and orientation of the lumen stent implanted in the body can be accurately and clearly displayed, facilitating the operator to observe, quickly judge, and timely adjust, thereby shortening the intracavitary treatment operation time and reducing the surgical difficulty. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention will be further described below in conjunction with the drawings and embodiments. In the drawings:

[0021] Figure 1 is the developing form presented by the developing mark of the existing lumen stent under X-ray;

[0022] Figure 2 is the front view of an exemplary lumen stent of the present invention;

[0023] Figure 3 is the rear view of an exemplary lumen stent of the present invention;

[0024] Figure 4 is the form presented by the first symbol mark after the lumen stent undergoes left torsion;

[0025] Figure 5 is the form presented by the first symbol mark after the lumen stent undergoes right torsion;

[0026] Figure 6 is the developing form presented by the annular mark on the branch stent of an exemplary lumen stent of the present invention under X-ray. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0027] In order to make the above objects, features, and advantages of the present invention more obvious and understandable, the following detailed description of the specific embodiments of the present invention will be given in conjunction with the drawings. Many specific details are set forth in the following description in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0028] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or there may also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which this invention belongs. The terms used herein in the specification of this invention are only for the purpose of describing specific embodiments and are not intended to limit this invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0030] In the field of interventional medicine, it is generally defined that the end of an implant (such as a lumen stent) closer to the heart after release is the proximal end, and the end farther from the heart is the distal end.

[0031] Please refer to Figure 2 , one embodiment of the present application provides a lumen stent 100, which includes a tubular stent and a radiopaque marker disposed on the tubular stent. The tubular stent includes a main stent 11, and the radiopaque marker includes a first marker 211 disposed on the peripheral wall of the main stent 11. Among them, the shape of the first marker 211 disposed on the main stent 11 is at least asymmetric along the longitudinal axis. The longitudinal axis here refers to a longitudinal straight line passing through the first marker 211, and this longitudinal straight line divides the first marker 211 into two halves on the left and right sides of the longitudinal straight line, and the left and right halves of the first marker 211 are asymmetric along this longitudinal straight line. When the first marker 211 that is asymmetric along the longitudinal axis in this embodiment is a planar image under fluoroscopy, if the orientation of the lumen stent is different, the different radiographic morphologies presented can not only indicate and locate axially, but also be quickly identified circumferentially, facilitating the operator to timely adjust the stent release orientation, greatly reducing the operation time and improving the operation success rate.

[0032] Preferably, in some embodiments, the first marker 211 has a non-axisymmetric shape. That is to say, the first marker 211 is a non-axisymmetric marker and does not have any axis of symmetry itself. In this embodiment, the non-axisymmetric first marker 211 is adopted. When the first marker 211 is pre-fixed on the tube wall of the main body stent 11, the shape of the first marker 211 presented to the observer's fixed field of view is unique, and the relative position and orientation relationship of this unique shape with respect to the main body stent 11 and the relative position and orientation relationship with respect to each branch / window on the main body stent 11 are all unique and fixed. Therefore, taking this as a reference, during the implantation process of the lumen stent, observe the developed shape presented by the actual development of the first marker 211, and then adjust the position of the lumen stent according to the known relative position and orientation relationship, so that the presented developed shape is the same as its preset shape, thereby accurately and quickly implanting the lumen stent into the preset position. Different from the "."-shaped identifier in the prior art, the non-axisymmetric first marker 211 in this embodiment establishes a unique position and orientation relationship with the stent through the symbol shape, and the developed marker can accurately and clearly display the position and orientation of the stent implanted in the body, facilitating the operator to observe, quickly judge and adjust in time, thereby shortening the intracavitary treatment operation time and reducing the surgical difficulty.

[0033] Further, for the convenience of manufacturing and clear development identification, the first marker 211 in this embodiment is a character-shaped developed marker. Preferably, referring to Figure 2 as shown, the symbol shape of the first marker 211 is in the shape of a "G". For this application, the "G" shape not only has a relatively uniform shape and strong stability, but more importantly, it has high recognition after development. Referring to Figure 2 , the development identification process of the first marker 211 in the shape of a "G" will be described in detail. The first marker 211 in the shape of a "G" is fixed in the middle of the lumen stent 100, so the distance from its proximal end port of the lumen stent 100 and the distance from the distal end port are both fixed. Therefore, during the implantation process, the axial position of the lumen stent can be identified by the distance. Further, since the first marker 211 in the shape of a "G" is directly in front of the front half A of the stent, when the lumen stent is normally implanted, the developed shape presented by the first marker 211 in the X-ray fluoroscopy as a planar image should be approximately the same as its own symbol shape. Therefore, under normal circumstances, the developed shape seen by the operator is in the shape of a "G". If the developed shape seen is not in the shape of a "G", then the lumen stent is twisted during the implantation process. If the developed shape is in the shape of an inverted "G", it means that the lumen stent has been twisted by 180°, that is, the orientations of the front half A and the rear half B of the lumen stent have been reversed; if the width of the developed shape seen is significantly narrowed, then there is a left twist or a right twist. As Figure 4 shown, if the straight line with an interruption k on the right side of the developed shape with a significantly narrowed width is closer to the central axis m, it proves that there is a left twist and the lumen stent needs to be rotated to the right. As Figure 5As shown, if the continuous straight line on the left side of the developing pattern with a significantly narrower width is closer to the central axis m, it proves that right torsion has occurred, and the lumen stent needs to be rotated to the left to identify the circumferential position of the lumen stent. Thus, the lumen stent can be quickly and accurately positioned by the above-mentioned non-axisymmetric G-shaped first marker 211 with high recognition. It should be noted that the symbolic form of the first marker 211 is not limited to the G shape, and any symbol with a non-axisymmetric and highly recognizable symbolic form is within the selectable range.

[0034] As one of the implementation manners, in combination with Figure 2 and Figure 3 shown, the main stent 11 includes two opposite halves (A, B), namely the front half A and the rear half B respectively. The first marker 211 is provided on the front half A or the rear half B, and the orthographic projection form of the first marker 211 on the plane where the front half A and the rear half B intersect is approximately the same as its own form. Preferably, for the convenience of observation and in line with the operator's observation habit, as Figure 2 shown, the first marker 211 is provided on the front half A, Figure 2 and the orthographic projection form of the G-shaped first marker 211 on the plane is the G shape. Generally, during the implantation of the lumen stent, the front half A of the main stent 11 is located above, that is, directly in front of the operator above the patient. In this way, when the first marker 211 is provided on the front half A, on the one hand, a clear developing pattern can be presented for easy observation; on the other hand, the developing pattern presented by the first marker 211 is consistent with the symbolic form of the first marker 211 observed in the normal viewing angle, without problems such as mirror image observation, and is more in line with the operator's usage habit. Of course, the first marker 211 can also be provided on the rear half B, and in this regard, it can be set according to actual needs.

[0035] Among them, when the lumen stent is normally implanted, it can be further defined that the developing pattern presented by the first marker 211 when the X-ray fluoroscopy is a planar image is approximately the same as its own form. That is to say, when the lumen stent is normally implanted, the orthographic projection form of the first marker 211 is approximately the same as its own form. That is, when the patient lies flat and the lumen stent is normally implanted, the first marker 211 is located directly above or directly below the wall of the lumen stent. At this time, the developing pattern presented when the X-ray fluoroscopy is a planar image is the orthographic projection form of the first marker 211 located directly above or directly below, and this form is approximately the same as its own form. It should be noted that since in the actual operation process, the judgment of sameness is made by the operator with the naked eye, therefore, in this embodiment, it is defined as approximately the same, allowing a certain error range, and this error range is subject to not affecting the normal implantation of the lumen stent.

[0036] Further, in some embodiments, the tubular stent further includes a branch stent. The branch stent has opposite distal and proximal openings, and one of the distal and proximal openings is connected to the side wall of the main stent, so that the lumen of the branch stent communicates with the lumen of the main stent. Among them, the first marker 211 is located on the peripheral wall of the main stent 11 at the end of the distal opening of the branch stent. Combining the foregoing, at this time, the first marker 211 that is asymmetric along the longitudinal axis presents different imaging morphologies in the X-ray fluoroscopy as a planar image. At the same time, the first marker 211 is located at the end of the distal opening of the branch stent. This first marker 211 can not only accurately position the lumen stent axially and circumferentially, but also identify the semi-released axial position of the stent. Combining Figure 2 and Figure 6 shown, the release of the sheath nozzle of the stent system is paused at the G-shaped first marker 211. At this time, the branch stent is just fully released. This first marker 211 further realizes the positioning of the semi-release process of the lumen stent. The first marker 211 of this embodiment not only realizes "multiple functions with one marker", but also its characteristic morphology realizes a clear and accurate positioning function.

[0037] Exemplarily, continue to refer to Figure 2 shown, the tubular stent includes two inner branches 12 and two outer branches 13 that communicate with the main stent 11. The main stent 11, the inner branches 12 and the outer branches 13 are all tubular stent structures with hollow lumens, and the hollow lumens form channels for blood flow. It should be noted that the installation position, the number of installed branch stents, and the length of the branch stents are not limited to this, and can be set according to actual needs.

[0038] Among them, as Figure 2As shown, the main body stent 11, the inner branch 12 and the outer branch 13 all include a bare stent 101 and a film 102 connected to the bare stent 101. Among them, the bare stent 101 is made of a material with good biocompatibility, such as materials like nickel-titanium and stainless steel. The film 102 is made of a polymer material with good biocompatibility, such as PTFE, FEP, PET, etc. The bare stent 101 includes multiple turns of waveform rings 1011, and the multiple turns of waveform rings 1011 are arranged in sequence from the proximal end to the distal end, preferably arranged at parallel intervals. The waveform ring 1011 is a closed cylindrical structure, and the multiple turns of waveform rings 1011 can have the same or similar waveform shapes. For example, the waveform ring 1011 can be a Z-shaped wave, an M-shaped wave, a V-shaped wave, a sine wave structure, or other structures that can be radially compressed into a very small diameter, etc. It can be understood that the specific structure of the waveform ring 1011 is not limited in this embodiment, the waveform of the waveform ring 1011 can be set as needed, and at the same time, the number of waveforms and the waveform height in each turn of the waveform ring 1011 can both be set as needed. In actual preparation, a nickel-titanium tube can be cut and shaped to form the bare stent 101, and then the bare stent 101 is sutured to the film 102.

[0039] As an implementation method, referring to Figure 2 As shown, the main body stent 11 includes a first main body segment 111, a taper segment 112 and a second main body segment 113 connected in sequence. The cross-sectional area of the first main body segment 111 is larger than that of the second main body segment 113. The two inner branches 12 and the two outer branches 13 are both connected to the taper segment 112. Among them, the distal end of the inner branch 12 is fixed on the taper segment 112, the proximal end is located inside the main body stent 11 and extends toward the side away from the second main body segment 113; the proximal end of the outer branch 13 is fixed on the taper segment 112, the distal end is located outside the main body stent 11 and extends toward the side away from the first main body segment 111.

[0040] During the operation, first, the first main body segment 111 is attached to the healthy blood vessel wall upstream of the aneurysm cavity, and the taper segment 112 and the second main body segment 113 are left in the aneurysm cavity. Subsequently, a guide wire (not shown) is passed through the inner branch 12 or the outer branch 13 and introduced into the branch blood vessel near the aneurysm cavity to establish a track. Then, one end of the branch stent is sleeved into the inner branch 12 or the outer branch 13, and the other end of the branch stent is located in this branch blood vessel. The blood flow passing through the main body stent 11 is introduced into this branch blood vessel through the branch stent.

[0041] In this application, two inner branches 12 and two outer branches 13 are connected to the tapered section 112. Since the tapered section 112 is closer to the first main section 111 than the second main section 113, the guiding wire has more operating space after passing through the distal end of the inner branch 12 or the outer branch 13, which facilitates the accurate introduction of the guiding wire into the branch blood vessel. Moreover, by providing two inner branches 12 and 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 branch stents are arranged out of position in the aneurysm cavity, avoiding extrusion between the branch stents.

[0042] Furthermore, since the intraoperative fluoroscopic X-ray image is a planar image, if the two outer branches 13 are too close to each other, the imaging markers of the two outer branches will interfere with each other, which is not conducive to the guiding wire being selected into the corresponding branch, affecting the surgical operation and prolonging the operation time. Therefore, the farther the two outer branches are from each other, the better. Similarly, if the adjacent inner branch 12 and outer branch 13 are too close to each other, it will cause interference to the guiding wire being selected into the outer branch 13 after the branch stent sleeved on the inner branch is connected first, and the imaging markers of the inner and outer branches will also interfere with each other. Therefore, the farther the inner and outer branches are from each other, the better. If the two inner branches and the two outer branches are symmetrically spaced, the imaging markers of the two inner branches are likely to interfere with each other in the planar fluoroscopic image. Therefore, the two inner branches 12 are located between the two outer branches 13. Therefore, it is necessary to reasonably design the positions between the inner branches 12 and the outer branches 13 to avoid interference of the imaging markers between the four branches, and to avoid the branches being too close to each other and affecting the selection of the guiding wire into the branches. In this embodiment, the two inner branches 12 are located between the two outer branches 13.

[0043] Please continue to refer to Figure 2 , four windows are provided on the main stent 11, two of which are inner branch windows connected to the inner branches 12, and the other two are outer branch windows connected to the outer branches 13. In other embodiments, the imaging marker further includes an annular marker 22 along the edge or near the edge of the distal opening and / or proximal opening of the branch stent. That is, the annular marker 22 is provided at the edge or near the edge of the four windows, and the edge or near the edge of the free ports of the two inner branches 12 and the two outer branches 13 is also provided with the annular marker 22. The annular marker 22 can image the outlet and inlet of the branch stent, facilitating the penetration and exit of the guide wire. Among them, whether to provide the annular marker 22 at the edge or near the edge of the end opening of the branch stent can be set as needed, and is not limited to the above exemplary illustration.

[0044] Furthermore, during the actual surgical process, it is particularly important to quickly and clearly identify the outlet and inlet of the branch stent so that the guide wire can penetrate in and out quickly. However, the fact is that the current X-ray fluoroscopy image during surgery is a planar image, and the planar images presented by the outlets and inlets of ordinary branch stents with horizontal cross-sectional openings are horizontal straight short lines. This results in the operator being unable to actually clearly identify the outlets and inlets of the branch stent, and also being unable to know the deployment state of the branch stent. In view of this, referring to Figure 2 and Figure 6 As shown, the distal opening and / or proximal opening of the branch stent in this embodiment are inclined with respect to the longitudinal central axis of the branch stent, so that the annular mark 22 is also inclined with respect to the longitudinal central axis of the branch stent. Generally, the inclination angle is greater than 10°. The inclined ports and the annular mark 22 in this embodiment make the entrances and exits of the branch stent appear three-dimensional after imaging. The annular structure is more convenient for the operator to clearly identify the deployment form of the branch entrances and exits, and can further judge whether the branch stent is fully deployed according to the deployment form of the entrances and exits, which is beneficial to the establishment of the branch stent channel. In addition, the inclined annular mark 22 is easy to distinguish and identify from the main body imaging mark, and is more easily radially compressed. The radial compression cross-section is smaller, so that the profile of the stent compressed in the sheath can be reduced, which is beneficial to the reduction of the sheath diameter.

[0045] Referring to Figure 2 , in order to more accurately position the proximal end of the lumen stent axially, the main body stent 11 includes opposite main proximal openings and main distal openings, and the imaging mark further includes a second mark 212 disposed adjacent to the main proximal opening. The circumferential orientation of the second mark 212 can be fixed as needed. In order to improve the accuracy of axial positioning, the second mark 212 is arranged as close to the port as possible.

[0046] Furthermore, since the proximal port of the lumen stent is the primary positioning position during the implantation of the lumen stent, the accuracy of the proximal port positioning is particularly important. In other embodiments, in order to further improve the accuracy of circumferential positioning while accurately positioning axially, the imaging mark further includes a third mark 213 disposed adjacent to the main proximal opening. Among them, the symbol forms of the second mark 212 and the third mark 213 are different, and the second mark 212 and the third mark 213 are arranged at intervals along the circumference of the main body stent. Positioning can be performed through two marks with different symbols in different orientations. Preferably, in order to further improve the recognition rate during circumferential positioning, the radial connection line n of the second mark 212 and the third mark 213 passes through the central axis m of the main body stent 11. That is to say, the radial connection line m of the second mark 212 and the third mark 213 is located on the half-section of the front and rear parts of the main body stent 11, that is, as Figure 2As shown, the second marker 212 and the third marker 213 are respectively located on the left and right sides of the lumen stent. At this time, the radial connection line between the first marker 211 and the central axis m of the main body stent 11 is perpendicular to the semi-section plane. That is, the second marker 212 and the third marker 213 are in a T shape with the first marker 211 in space. In this way, when implanted normally, the developed forms presented by the second marker 212 and the third marker 213 are two vertical short lines. If torsion occurs, the developed forms of the second marker 212 and the third marker 213 will change, so that based on the first marker 211, it can be further judged whether the orientation of the lumen stent is accurate, improving the recognition and accuracy.

[0047] Referring to Figure 2 , in order to more accurately position the axial distal end of the lumen stent, the main body stent 11 further includes a fourth marker 214 disposed adjacent to the main distal opening. Among them, the circumferential orientation setting of the fourth marker 214 can be fixed as required. And in order to improve the accuracy of axial positioning, the fourth marker 214 is arranged as close as possible to the far end port. Preferably, the first marker 211 and the fourth marker 214 are located on the same longitudinal line, and the radial connection lines between the first marker 211 and the fourth marker 214 and the central axis m of the main body stent 11 are both perpendicular to the radial connection line of the second marker 212 and the third marker 213. In this way, it can also ensure that the symbol form of the fourth marker 214 can be clearly seen during the normal implantation process.

[0048] Exemplarily, referring to Figure 2 As shown, the second marker 212, and / or the third marker 213, and / or the fourth marker 214 are character-shaped developed markers, and their symbol forms are in the shape of 0 or 8. The selection of 0 or 8, on the one hand, the symbol is smooth and closed as a whole, without any spiky protrusions, and will not cause any impact on the blood vessel wall during the contact between the proximal end of the lumen stent and the blood vessel wall. On the other hand, the symbol form is uniform and has good fixing stability.

[0049] It can be understood that, in order to facilitate identification, the symbol forms of the second marker 212 and the third marker 213 are different. Therefore, when the symbol form of the second marker 212 is in the shape of 0, the symbol form of the third marker 213 can be selected to be in the shape of 8. For the convenience of suture fixation, the symbol form of the fourth marker 214 is in the shape of 0. It should be noted that the selection of the symbols of the second marker 212, the third marker 213, and the fourth marker 214 is not limited to this, and can be continued to be selected according to actual needs.

[0050] Referring to Figure 2As shown, when the distal end of the lumen stent needs to be connected to an extension stent, the imaging marker further includes a fifth marker 215 provided on the main body stent and at a preset distance from the main distal opening, where the preset distance is not less than 20 mm. Through the fifth marker 215, the proximal end of the extension stent membrane can be axially positioned, and the preset distance of not less than 20 mm effectively ensures the length of the overlapping segment and prevents the extension stent from falling off. Preferably, the symbol shape of the fifth marker is U-shaped. Preferably, the first marker 211 and the fifth marker 215 are located on the same longitudinal line, and the radial connections of the first marker 211 and the fifth marker 215 to the central axis m of the main body stent 11 are perpendicular to the radial connections of the second marker 212 and the third marker 213. In this way, the symbol shape of the fifth marker 215 can also be clearly seen during normal implantation.

[0051] Furthermore, when the first marker 211, the fourth marker 214, and the fifth marker 215 are provided simultaneously, the first marker 211, the fourth marker 214, and the fifth marker 215 are located on the same straight line, and the radial connections of the first marker 211, the fourth marker 214, and the fifth marker 215 to the central axis m of the main body stent 11 are perpendicular to the radial connections of the second marker 212 and the third marker 213. That is, the second marker 212 and the third marker 213 are in a T-shaped spatial relationship with the straight line where the first marker 211, the fourth marker 214, and the fifth marker 215 are located. In this way, during normal implantation, the imaging forms presented by the second marker 212 and the third marker 213 are two vertical short lines, while the first marker 211, the fourth marker 214, and the fifth marker 215 present a complete and clear symbol shape, positioning the lumen stent in all directions and at multiple angles, thus facilitating quick and accurate positioning. Refer to Figure 2 , in this embodiment, by setting imaging markers with two different symbols (the second marker 212 and the third marker 213 respectively) for accurately positioning the proximal position on both sides of the proximal port, a second marker 212 for accurately positioning the distal position directly in front of the distal port, a first marker 211 for realizing axial, circumferential, and whether it is fully released asymmetrically directly in front of the middle position, and a fifth marker 215 for axially positioning the proximal end of the extension stent membrane between the first marker 211 and the fifth marker 212, the forms and functions of each marker do not overlap, and for the operator, they can be clearly and quickly recognized without confusion.

[0052] Among them, the first marker 211, the second marker 212, the third marker 213, the fourth marker 214 and the fifth marker 215 of this embodiment are rigid developing markers. On the one hand, the rigid developing markers are small in volume and will not cause an increase in the radial dimension after the lumen stent is squeezed, so that it is easy to be loaded into the sheath. On the other hand, the morphology of the rigid developing markers will not change due to the lumen stent being loaded into the sheath tube. The developing markers present the same morphology before and after release. In this way, before releasing the lumen stent, the operator can see the markers on the lumen stent in the sheath tube through the DSA digital imaging device, so as to timely adjust the orientation of the sheath tube to change the orientation of the lumen stent before release, and further ensure the accurate positioning of the lumen stent during release. And the annular marker 22 of this embodiment is a flexible developing marker. The flexible annular marker 22 is easy to be squeezed on the one hand and will not cause an increase in the radial dimension after the lumen stent is squeezed, which is convenient for loading into the sheath. On the other hand, the flexible annular marker 22 is easy to unfold after release, and the unfolding morphology of the annular marker 22 can be used to further judge whether the branch stent is well unfolded.

[0053] Further, barbed structures (not shown) are provided on the outer wall of the first main body segment 111 to enhance the overall anchoring performance of the tubular stent. When other stents are sleeved on the proximal end of the first main body segment 111, if the barbed structure is too close to the proximal end of the first main body segment 111, the barbed structure is likely to pierce the sleeved other stents to form internal leakage. However, if the barbed structure is too close to the inner branch 12, it will affect the overall flexibility of the lumen stent. Therefore, the barbed structure is fixed on the outer wall of the first main body segment 111 and is located between the proximal end of the inner branch 12 and the proximal end of the first main body segment 111.

[0054] Further, a semi-release device (not shown) is provided on the outer surface of the lumen stent 100 to accurately position the lumen stent 100.

[0055] Since the lumen stent 100 is mainly axially and circumferentially positioned by the developing markers thereon, when the lumen stent 100 is compressed in the delivery sheath tube, it has circumferential compression wrinkles and is in an extended state axially. If positioned by the developing markers at this time, there will be large circumferential and axial deviations. In this application, a semi-release device is provided on the outer surface of the lumen stent 100. When the lumen stent 100 is completely released from the delivery sheath tube, under the constraint of this semi-release device, the lumen stent 100 is in a semi-release state. At this time, the lumen stent 100 does not fit the blood vessel wall, and the operator can still adjust the axial and circumferential positions of the lumen stent 100. After accurate positioning, the constraint of the semi-release device is then released to make the lumen stent 100 unfold and adhere to the wall.

[0056] It can be understood that when the lumen stent 100 is in a semi-released state, if the diameter of the circumscribed circle of its cross-section is too large, the stent is likely to adhere to the wall, which is not conducive to axial and circumferential adjustment; if the diameter of the circumscribed circle of its cross-section is too small when the lumen stent 100 is in a semi-released state, the effect of semi-release is not significant, and there are still large circumferential and axial positioning deviations. Therefore, in this embodiment, the ratio of the diameter of the circumscribed circle of the cross-section of the lumen stent 100 in the semi-released state to the diameter of the circumscribed circle of the cross-section of the lumen stent 100 when it is deployed is 0.6 to 0.8.

[0057] In the present invention, a non-axisymmetric imaging marker is provided on the main body stent. Through this imaging marker, the position and orientation of the lumen stent implanted in the body can be accurately and clearly displayed, facilitating the operator to observe, quickly judge and timely adjust, thereby shortening the operation time of endovascular treatment and reducing the operation difficulty.

[0058] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.

[0059] The above-described embodiments only represent several implementation manners of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limitations on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent should be subject to the appended claims.

Claims

1. A luminal stent, characterized in that: It includes a tubular support and a development mark, the tubular support includes a main support, the development mark includes a first mark provided on the main support, wherein the shape of the first mark provided on the main support is asymmetric at least along the longitudinal axis; the main support includes a main proximal opening and a main distal opening relative to each other, the development mark also includes a second mark and a third mark provided adjacent to the main proximal opening, the second mark and the third mark have different shapes, the second mark and the third mark are arranged at intervals along the circumference of the main support, and the radial line connecting the second mark and the third mark passes through the longitudinal center axis of the main support, and the radial line connecting the first mark and the longitudinal center axis of the main support is perpendicular to the radial line connecting the second mark and the third mark.

2. The endoluminal stent according to claim 1, characterized in that: The main body bracket includes a relative front half and a rear half, the first mark is set on the front half or the rear half, and the orthographic projection shape of the first mark on the plane where the front half and the rear half intersect is approximately the same as its own shape.

3. The endoluminal stent according to claim 1, characterized in that: The first mark has a non-axisymmetric shape.

4. The endoluminal stent according to claim 1, characterized in that: The tubular stent also includes a branch stent, which has a relative distal opening and a proximal opening, one of the distal opening and the proximal opening is connected to the side wall of the main stent, so that the lumen of the branch stent is connected to the lumen of the main stent; wherein the first mark is located on the main stent at the end of the distal opening of the branch stent.

5. The endoluminal stent according to claim 4, characterized in that: The visualization mark further includes an annular mark provided on or near the edge of the distal opening and / or the proximal opening of the branch stent.

6. The endoluminal stent according to claim 5, characterized in that: The distal opening and / or the proximal opening of the branch stent are arranged to be tilted relative to the longitudinal center axis of the branch stent, so that the annular mark is also tilted relative to the longitudinal center axis of the branch stent.

7. The endoluminal stent according to claim 1, characterized in that: The main support also includes a fourth marking disposed adjacent to the main distal opening.

8. The endoluminal stent according to claim 7, characterized in that: The fourth mark and the first mark are located on the same longitudinal straight line.

9. The endoluminal stent according to claim 1, characterized in that: The development mark further includes a fifth mark provided on the main body support and at a preset distance from the main distal end opening, wherein the preset distance is not less than 20 mm.

10. The endoluminal stent according to claim 9, characterized in that: The fifth mark and the first mark are located on the same longitudinal straight line.

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