CN111035470A

CN111035470A - Tectorial membrane bracket component and lumen stent

Info

Publication number: CN111035470A
Application number: CN201811190647.XA
Authority: CN
Inventors: 肖本好; 何里明
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2018-10-12
Filing date: 2018-10-12
Publication date: 2020-04-21
Anticipated expiration: 2038-10-12
Also published as: CN111035470B

Abstract

The invention discloses a film covering bracket assembly and a lumen bracket, wherein the film covering bracket assembly comprises a bare bracket and a film covering connected to the bare bracket, the bare bracket comprises a multi-circle wavy annular object, a blocking area and an opening area are arranged on the side wall of the film covering bracket assembly, the opening area and the blocking area are oppositely arranged, and the opening area extends to the end part of the film covering bracket assembly. The invention has the beneficial effects that: the opening area extending to the end part of the covered stent assembly is arranged on the side wall of the covered stent assembly, so that the area where guide wires can be introduced can be increased, and the introduction time is shortened.

Description

Tectorial membrane bracket component and lumen stent

Technical Field

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

Background

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

When the end part of the covered stent is required to be sleeved with the extension stent, a guide wire is introduced from the opening at the end part of the covered stent, and a track of the extension stent is established through the guide wire. However, since the X-ray fluoroscopic image during the operation is a planar image, the operator cannot accurately introduce the guide wire from the opening at the end of the stent graft under the monitoring of the planar image, which not only increases the time required for introducing the guide wire and the operation time, but also causes the failure of the operation because the guide wire cannot be introduced into the stent graft. If the operation time is too long, serious complications such as branch artery ischemia and lower limb dysfunction can be caused.

Disclosure of Invention

The invention aims to solve the technical problem that a covered stent component and a lumen stent cannot be quickly introduced when a stent is sleeved and connected in the prior art.

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

the utility model provides a tectorial membrane bracket component, include naked support and connect tectorial membrane on the naked support, naked support includes many rings of wave form annulars, be provided with on tectorial membrane bracket component's the lateral wall and block district and opening district, the opening district with block the relative setting in district, the opening district extends to tectorial membrane bracket component's tip.

In the film covering bracket assembly, the end part of the film covering bracket assembly, which is provided with the opening area, is of a bell mouth structure.

In the stent module of the present invention, the corrugated annulus of the stent module near the open area has a high-low wave structure.

In the film-covered bracket assembly, the ratio of the two different wave heights of the high-low wave structure is 0.2-0.9.

In the stent module according to the present invention, the plurality of open regions and the plurality of blocking regions are circumferentially spaced apart from each other.

In the stent module of the present invention, a minimum distance between any point on an edge of the open area and any point on the wavy annular object adjacent to the open area is not less than 0.5 mm.

In the stent graft assembly of the present invention, the stent graft assembly further comprises a strut connecting two rings of the undulating ring.

In the covered stent assembly, the ratio of the wire diameter of the wavy ring to the wire diameter of the support member is 0.8-1.2.

In the film covered bracket assembly, the wave crest of one circle of the waveform ring object is abutted to the wave trough of the other circle of the waveform ring object; or the wave crest of one circle of the wavy ring-shaped object and the wave trough of the other circle of the wavy ring-shaped object are mutually hooked and wound.

The utility model provides a lumen stent, including the stent main part, still include as above-mentioned tectorial membrane bracket component, tectorial membrane bracket component connects in the stent main part.

In summary, the covered stent assembly and the lumen stent of the present invention have the following advantages: the opening area extending to the end part of the covered stent assembly is arranged on the side wall of the covered stent assembly, so that the area where guide wires can be introduced can be increased, and the introduction time is shortened. Because still be provided with on the lateral wall of tectorial membrane bracket component and block the district with the opening district relative, should block the district and not only can avoid the seal wire to wear out from the contralateral of opening district at the in-process that advances forward, when the seal wire is introduced from the opening district moreover and when pushing up on blocking the district, the seal wire can be in the same place the entering lumen under the effect of the effect that advances forward, further shortens the induction time of seal wire, reduces the risk because the operation time overlength brings.

Drawings

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

FIG. 1 is a schematic diagram of a lumen stent provided in accordance with one embodiment of the present invention;

FIG. 2 is an enlarged view of section B of the luminal stent shown in FIG. 1;

FIG. 3 is a cross-sectional view taken along line A-A of the luminal stent shown in FIG. 1;

FIG. 4 is a cross-sectional view of a first stent-graft assembly of the luminal stent shown in FIG. 1 having two open areas;

FIG. 5 is a cross-sectional view of a first stent-graft assembly of the luminal stent shown in FIG. 1 having five open areas;

FIG. 6 is a schematic view of a first stent-graft assembly of the luminal stent shown in FIG. 1;

FIG. 7 is a schematic view of the struts of the luminal stent of FIG. 1 attached to two rings of undulating rings by fasteners;

FIG. 8 is a schematic view of the support member of the luminal stent of FIG. 1 wrapped around two undulating rings;

FIG. 9 is a schematic view of the two-turn undulating rings of the luminal stent of FIG. 1 with the peaks abutting the valleys;

FIG. 10 is a schematic view of the two-turn undulating ring of the luminal stent of FIG. 1 with the peaks and valleys hooked around each other;

FIG. 11 is a schematic structural diagram of a lumen stent provided in accordance with a second embodiment of the present invention;

FIG. 12 is a schematic view of the first branch of the luminal stent of FIG. 11;

FIG. 13 is a schematic structural view of a lumen stent provided in accordance with a third embodiment of the present invention;

FIG. 14 is an enlarged view of section C of the luminal stent shown in FIG. 13.

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.

Referring to fig. 1, a lumen stent 100 according to an embodiment of the present invention includes a bare stent 110 and a covering film 120 connected to the bare stent 110. 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 110 is made of a material with good biocompatibility, such as nickel titanium, stainless steel, etc. The coating 120 is made of a polymer material with good biocompatibility, such as PTFE, FEP, PET, etc. The bare stent 110 includes a plurality of undulating rings 111, the plurality of undulating rings 111 being arranged in sequence, preferably in parallel spaced apart arrangement, from the proximal end to the distal end. The wavy rings 111 are closed cylindrical structures, and the multiple circles of wavy rings 111 may have the same or similar wavy shapes therebetween, for example, the wavy rings 111 may be Z-shaped waves, M-shaped waves, V-shaped waves, sinusoidal-shaped waves, or other structures capable of being radially compressed to a small diameter. It is understood that the present embodiment is not limited to the specific structure of the wavy ring 111, the wave shape of the wavy ring 111 can be set according to the requirement, and the number of wave shapes and the height of wave shapes in each circle of the wavy ring 111 can be set according to the requirement. In actual preparation, the bare stent 110 may be formed by braiding ni-ti wires or cutting and shaping ni-ti tubes, and then the covering film 120 may be fixed on the bare stent 110 by sewing or high-temperature pressing on the surface of the bare stent 110.

In the embodiment shown in fig. 1, the luminal stent 100 is an abdominal aorta stent, which comprises a stent main body 101, and a first stent graft component 102 and a second stent graft component 103 which are respectively connected to one end of the stent main body 101. The term "covered stent assembly" as used herein refers to a structure in which a bare stent 110 is covered with a thin film 120.

Referring to fig. 2 and fig. 3, a blocking area 10 and an opening area 20 are respectively disposed on a side wall of an end of the first stent assembly 102 away from the stent main body 101, the blocking area 10 is disposed opposite to the opening area 20, and the opening area 20 extends to an end of the first stent assembly 102 and is communicated with an opening at the end of the first stent assembly 102. It should be noted that the phrase "the blocking area 10 is disposed opposite to the opening area 20" means that a plane passing through the geometric center of the blocking area 10 or the opening area 20 and passing through the longitudinal center axis of the stent assembly is defined as a first plane, and a plane passing through the longitudinal center axis of the stent assembly and perpendicular to the first plane is defined as a second plane, so that the projection of the opening area 20 and the blocking area 10 in the second plane coincides, or the projection of the opening area 20 in the second plane is located in the projection of the blocking area 10 in the second plane, or the projection of the blocking area 10 in the second plane is located in the projection of the opening area 20 in the second plane.

Since the sidewall of the first stent assembly 102 is provided with the opening area 20 extending to the end of the first stent assembly 102, when the track of the extension stent (not shown) is established by the guide wire 30, the guide wire 30 can be introduced from not only the end of the first stent assembly 102 but also the opening area 20 at the side of the first stent assembly 102, so that by providing the opening area 20 extending to the end of the first stent assembly 102, the area into which the guide wire 30 can be introduced can be increased, the accuracy of introducing the guide wire 30 into the first stent assembly 102 can be improved, thereby shortening the introduction time and reducing the risk caused by the excessively long operation time. In addition, since the sidewall of the first stent graft assembly 102 is further provided with a blocking region 10 opposite to the ostium region 20, the blocking region 10 prevents the guidewire 30 from passing out of the opposite side of the ostium region 20 during advancement of the guidewire 30 as it is introduced through the ostium region 20. Moreover, when the guide wire 30 enters the first stent graft assembly 102 from the open area 20, if the guide wire 30 abuts against the blocking area 10 during the forward advancing process, the guide wire 30 will enter the lumen along the way under the force of the forward advancing force, thereby further improving the accuracy of the guide wire 30 in the first stent graft assembly 102 and shortening the time for introducing the guide wire 30.

In the embodiment shown in fig. 2 and 3, the sidewall of the first stent assembly 102 is provided with an open area 20, the region of the covering film on the sidewall of the first stent assembly 102 opposite to the open area 20 forms the barrier area 10, and the covering film on the barrier area 10 and the covering film outside the barrier area 10 may be an integral structure.

It is understood that the number of open areas 20 is not limited in this embodiment, and in other embodiments, a plurality of open areas 20 may be provided on the sidewall of the first stent assembly 102. Referring to fig. 4, the sidewall of the first film covering support assembly 102 is respectively provided with two blocking

regions

10a, 10b and two opening

regions

20a, 20b, wherein the blocking region 10a is centrosymmetric to the opening region 20a, and the blocking region 10b is centrosymmetric to the opening region 20 b. Referring to fig. 5, the sidewall of the first stent assembly is provided with five

opening regions

20a, 20b, 20c, 20d, 20e, the sidewall of the first stent assembly is further provided with blocking

regions

10a, 10b, 10c, 10d, 10e which are respectively centrosymmetric to the

opening regions

20a, 20b, 20c, 20d, 20e, and the opening regions 20 and the blocking regions 10 are arranged at intervals along the circumferential direction.

It will also be appreciated that in other embodiments, the coating of the barrier region 10 may not be integral with the coating of the barrier region 10, such as the coating of the barrier region 10 may be fixedly connected to the coating of the barrier region 10 by sewing, heat fusing, or the like. It will also be appreciated that in other embodiments, the barrier region 10 may be other barrier structures (e.g., partial convolutions of a bare stent) attached to the inner wall of the first stent-graft assembly 102, so long as the guidewire 30 is blocked from passing through the barrier region 10. It will also be appreciated that in other embodiments, the barrier region 10 may have perforations or the edge of the barrier region 10 may have a groove recessed from a portion of the edge into the barrier region 10, so long as the perforations or the opening of the groove are sized to still prevent the guidewire from passing through the barrier region 10.

In the embodiment shown in FIG. 1, the length of the first stent assembly 102 is less than the length of the second stent assembly 103. During operation, firstly, one end of the stent main body 101 of the covered stent assembly 100, which is far away from the first covered stent assembly 102, is attached to the healthy blood vessel wall at the upstream of the tumor cavity, and meanwhile, the first covered stent assembly 102 is suspended and detained in the tumor cavity, and the second covered stent assembly 103 is positioned in one branch blood vessel at the downstream of the tumor cavity. The guidewire 30 is then introduced into the first stent graft assembly 102 through the other branch vessel to create a track, with one end of the elongate stent nested within the first stent graft assembly 102 and the other end of the elongate stent positioned within the other branch vessel. It is understood that in other embodiments, when the first stent graft assembly 102 and the second stent graft assembly 103 are both required to be sleeved with an extension stent, the ends of the first stent graft assembly 102 and the second stent graft assembly 103 away from the stent body 101 may be respectively provided with a centrally symmetric blocking area 10 and an open area 20.

It should be understood by those of ordinary skill in the art that the abdominal aorta stent of the present embodiment is only used as an example and is not limited to the present application, and the luminal stent 100 of the present application can be any covered luminal stent with a bare stent, including but not limited to an abdominal aorta stent, and can also include a thoracic aorta stent, an iliac artery stent, etc. For example, when the luminal stent 100 is a thoracic aortic stent, the thoracic aortic stent comprises a tubular stent graft assembly having a barrier zone 10 and an open zone 20 disposed on a proximal or distal sidewall of the stent graft assembly, the barrier zone 10 being disposed opposite the open zone 20. Further, the thoracic aortic stent may further include a branch stent connected to the stent graft assembly.

Referring to fig. 2 again, in order to keep the bare stent 110 within the covering range of the covering film 120, the minimum value of the distance m between any point on the edge of the opening area 20 and any point on the wavy annular object 111 close to the opening area 20 is not less than 0.5 mm. When the minimum value of the above-mentioned distance m is less than 0.5mm, the bare stent 110 is easily exposed from the edge of the open area 20, even a gap is generated between the bare stent 110 and the cover film 120. During the introduction of the guide wire 30, if the guide wire 30 passes through the gap between the bare stent 110 and the cover 120, the track of the extended stent may fail to be established, eventually leading to a failure of the surgery.

In the embodiment shown in fig. 2, the edges of the open area 20 are disposed parallel to the undulating ring 111 adjacent the open area 20. It is understood that in other embodiments, the edge of the opening area 20 may be inclined with respect to the wavy ring 111 near the opening area 20 as long as the above-mentioned minimum value of m is not less than 0.5 mm.

Further, if the overlapping length of the first stent graft 102 of the extension stent and the abdominal aorta stent (or the stent graft 102 of the thoracic aorta stent) is too short, not only the connection strength between the extension stent and the first stent graft 102 is reduced, but also the extension stent and the first stent graft 102 are easily separated under the blood flow impact, which results in the failure of the operation, and the sealing performance of the first stent graft 102 and the extension stent is weakened, so that a gap is formed between the first stent graft 102 and the extension stent which are mutually sleeved, and the blood flow continuously flows into the tumor cavity. Therefore, in order to increase the connection strength between the first stent assembly 102 and the extension stent and avoid a gap between the first stent assembly 102 and the extension stent, the overlapping length of the first stent assembly 102 and the extension stent along the axial direction needs to be ensured. Referring to FIG. 6, the height difference n between the first stent assembly 102 and the open area 20 is preferably not less than 15 mm. Because the side wall of the covered stent assembly 100 is provided with the opening area 20, when the height difference n between the first covered stent assembly 102 and the opening area 20 is not less than 15mm, the operator can be ensured to have enough operating space, the overlapping length of the covered stent assembly 100 and the extension stent along the axial minimum covering film is not less than 15mm, and the occurrence of internal leakage is avoided.

Referring to fig. 7 and 8, the stent assembly further includes a supporting member 130 connecting the two rings of the corrugated rings 111 for increasing the axial supporting force of the stent. If the axial supporting force of the covered stent assembly is poor, in the process of introducing the guide wire 30, when the guide wire 30 abuts against the covered stent assembly, the stent section near the opening area 20 is bent or swayed under the abutting action of the guide wire 30, so that the guide wire 30 cannot smoothly enter the lumen of the covered stent assembly.

Preferably, the support 130 is located near the ostium 20 for connecting two rings of undulating rings 111 near the ostium 20 to increase the axial support of the stent segment near the ostium 20 to prevent the stent graft assembly from bending or wobbling under the interference of the guidewire 30.

Among them, the supporting member 130 may be made of a material having good biocompatibility, such as a nickel titanium wire, a stainless steel wire, etc. The supporting member 130 may be formed by a single connecting wire or by winding a plurality of connecting wires, and the ratio of the wire diameter of the wavy ring 111 to the wire diameter of the supporting member 130 is 0.8-1.2. When the ratio is less than 0.8, namely the wire diameter of the wavy ring 111 is relatively small, the radial supporting force of the wavy ring 111 is reduced, and the anchoring performance of the end part of the covered stent assembly is reduced; when the ratio is greater than 1.2, i.e., the wire diameter of the supporting member 130 is relatively small, the axial supporting force of the supporting member 130 is weak, and the supporting member does not function as an axial support.

It is understood that the present embodiment does not limit the specific connection manner between the supporting member 130 and the wavy ring 111. For example, in the embodiment shown in fig. 7, the wave crest of one ring of the wavy ring 111 is opposite to the wave trough of the other ring of the wavy ring 111, and both ends of the supporting member 130 are fixed to the two rings of the wavy ring 111 by the fixing members 131. In the embodiment shown in fig. 8, the wave crest of one turn of the wavy ring 111 is disposed opposite to the wave trough of the other turn of the wavy ring 111, and the supporting member 130 is wound around the two turns of the wavy ring 111.

It will also be appreciated that in other embodiments, the stent graft assembly may also have other means for increasing the axial support of the stent segment adjacent the ostium area 20. For example, in the embodiment shown in FIG. 9, the peaks on one ring of the undulating rings 111 abut against the valleys on the other ring of the undulating rings 111 to prevent axial shortening. In the embodiment shown in fig. 10, the peaks of one ring of the corrugated rings 111 are hooked with the valleys of another ring of the corrugated rings 111, and when the stent-graft component 100 is axially stretched, the hooked peaks and valleys are fastened together, so as to ensure the structural stability of the stent.

Referring to fig. 11, a lumen stent 100 according to a second embodiment of the present invention is substantially the same as the lumen stent of the first embodiment, and the lumen stent 100 is an abdominal aorta stent and includes a stent main body 101, and a first stent graft assembly 102 and a second stent graft assembly 103 respectively connected to one end of the stent main body 101. The second embodiment is different from the first embodiment in that one end of the first stent graft assembly 102 away from the stent body 101 is in a bell-mouth structure, that is, the end of the first stent graft assembly 102 at which the open region 20 is arranged is in a bell-mouth structure, so as to increase the open area of the end of the stent graft assembly at which the open region 20 is arranged, thereby increasing the area into which the guide wire 30 can be introduced and improving the accuracy of introducing the guide wire 30 into the stent graft assembly.

In the embodiment shown in FIG. 11, the first stent assembly 102 has petal-shaped end portions, the blocking region 10 is disposed opposite to the open region 20, and the plurality of open regions 20 and the plurality of blocking regions 10 are circumferentially spaced apart.

Specifically, referring to fig. 12, the first stent assembly 102 includes a branch main body 1021 and a flare 1022 connected thereto, wherein a ratio of a minimum diameter D1 of the branch main body 1021 to a maximum diameter D2 of the flare 1022 is 0.4-0.95. If the ratio D1/D2 is less than 0.4, the maximum diameter of the flare 1022 is relatively too large, which may affect the deployment of the stent in the body and thus the telescoping of the stent. If the ratio is greater than 0.95, i.e., the maximum diameter of the flare 1022 is relatively too small, the increase of the opening area of the end of the first stent assembly 102 where the open region 20 is located is relatively small, and the accuracy of introducing the guide wire 30 into the first stent assembly 102 cannot be effectively improved.

Referring to fig. 13 and 14, a luminal stent 100 is provided in a third embodiment of the present invention, which is substantially the same as the luminal stent in the first embodiment, the luminal stent 100 is an abdominal aorta stent, and comprises a stent main body 101, and a first stent assembly 102 and a second stent assembly 103 respectively connected to one end of the stent main body 101. The third embodiment differs from the first embodiment in that the corrugated annulus 111 near the open area 20 of the first stent assembly 102 is of a high-low wave configuration to increase the open area of the end of the stent assembly where the open area 20 is located, thereby increasing the area into which the guidewire 30 can be introduced.

Specifically, the ratio h1/h2 of two different wave heights of the wavy ring 111 is 0.2 to 0.9, preferably 0.3 to 0.7. When the ratio of h1/h2 is less than 0.2, the height difference between two different wave heights is large, so that the waveform structure of the waveform ring 111 is unstable; when the ratio of h1/h2 is greater than 0.9, the height difference of two different wave heights is difficult to represent, and the guide wire is not favorable for being introduced from a low wave position.

In the embodiment shown in FIG. 13, the first stent assembly 102 has petal-shaped end portions, the blocking region 10 is disposed opposite to the open region 20, and the plurality of open regions 20 and the plurality of blocking regions 10 are circumferentially spaced apart. A plane passing through the geometric center of the blocking area 10 or the open area 20 and passing through the longitudinal center axis of the stent graft assembly is defined as a first plane, and a plane passing through the longitudinal center axis of the stent graft assembly and perpendicular to the first plane is defined as a second plane, wherein the projection of a portion of the open area 20 in the second plane is located within the projection of the blocking area 10 in the second plane, and the projection of a portion of the blocking area 10 in the second plane is located within the projection of the open area 20 in the second plane.

Preferably, the height of the waveform ring 111 gradually decreases in a direction from a side facing the second stent assembly 103 to a side facing away from the second stent assembly 103, so as to facilitate the entry of the guidewire 30 into the first stent assembly 102 from the side facing away from the second stent assembly 103. It should be noted that the side facing toward or away from the second stent graft assembly 103 means the side of the first stent graft assembly 102 facing toward or away from the second stent graft assembly 103 after the luminal stent 100 is completely sleeved with the extension stent.

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. The utility model provides a tectorial membrane bracket component, includes naked support and connects tectorial membrane on the naked support, naked support includes many rings of wave form annulars, its characterized in that, be provided with on tectorial membrane bracket component's the lateral wall and block district and opening district, the opening district with block the relative setting in district, the opening district extends to tectorial membrane bracket component's tip.

2. The stent assembly of claim 1, wherein the end of the stent assembly at which the open area is located is of a flared configuration.

3. The stent assembly of claim 1, wherein the undulating annulus of the stent assembly proximate the open area is a high-low wave structure.

4. The stent assembly of claim 3, wherein the ratio of the two different wave heights of the high-low wave structure is 0.2-0.9.

5. The stent assembly of claim 1, wherein a plurality of the open areas are circumferentially spaced from a plurality of the barrier areas.

6. The stent assembly of claim 1, wherein the minimum distance between any point on the edge of the open area and any point on the undulating ring proximate the open area is no less than 0.5 mm.

7. The stent assembly of claim 1, further comprising a strut connecting two rings of the undulating rings.

8. The stent assembly of claim 7, wherein the ratio of the wire diameter of the undulating ring to the wire diameter of the struts is 0.8 to 1.2.

9. The stent assembly of claim 1, wherein a peak of one of the wave rings abuts a valley of another of the wave rings; or the wave crest of one circle of the wavy ring-shaped object and the wave trough of the other circle of the wavy ring-shaped object are mutually hooked and wound.

10. A lumen stent comprising a stent body and further comprising the stent graft assembly of any one of claims 1-9, wherein the stent graft assembly is attached to the stent body.