Endoluminal stent and stent system

Abstract

An endoluminal stent and a stent system. The endoluminal stent (100) comprises a stent main body (10), a controlled-release structure (30) and a development assembly (40). The controlled-release structure (30) comprises a restraining unit (31) and a restraining point (33). The endoluminal stent (100) comprises a first region (100a) and a second region (100b) in a circumferential direction. It is defined that in a state where the endoluminal stent (100) naturally expands, a region of the endoluminal stent in the circumferential direction that can be spanned by the restraining unit (31) is the first region (100a), and a region in the circumferential direction that cannot be spanned by the restraining unit is the second region (100b). The restraining point (33) is arranged in the second region (100B), and the development assembly (40) is configured to indicate the position of the restraining point (33) in the circumferential direction. By providing the development assembly (40) to indicate the position of the restraining point (33) in the circumferential direction, the endoluminal stent (100) can be prevented from placing the second region, which is traversed by a limiting rod (73) on a lesser curvature side of a blood vessel when a controlled-release state is to be deactivated, thereby avoiding distal endoleak.

Description

Luminal stents and stent systems Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a lumen stent and a stent system. Background Art

[0002] Aortic aneurysms and aortic dissections are currently serious diseases that endanger human life. If not actively treated, the aortic aneurysm and dissection will continue to grow and eventually rupture, causing serious complications and death. With the increasing number of patients with hypertension, hyperlipidemia, and hyperglycemia, the incidence of aortic aneurysms and aortic dissections is also increasing significantly. Traditional open surgical treatment of aortic aneurysms and aortic dissections is highly invasive, has a high mortality rate, a long operation time, a high incidence of postoperative complications, and is difficult to perform. Endovascular treatment, however, has gradually become the main treatment for aortic aneurysms and aortic dissections due to its less invasive nature, fewer postoperative complications, shorter operation time, and lower surgical difficulty. By implanting a covered stent in the aorta, the vascular lesions are isolated outside the covered stent, and blood flow is restricted to flow through the covered stent, thereby achieving the purpose of protecting the blood vessels.

[0003] During stent graft implantation, it's common for the stent to partially adhere to the wall but not fully release, leading to a "wind bag effect." This occurs when the proximal end of the stent adheres to the wall but the distal end remains unreleased, blocking blood flow. As the heart continues to pump blood, more and more blood is blocked at the stent's location, causing the stent to resemble a bulging bag. This "wind bag effect" is extremely dangerous during surgery because, while blood flow is blocked, the heart continues to pump blood, leading to persistently high blood pressure, potentially rupturing blood vessels, and causing cardiac overload, which can severely lead to death. This "wind bag effect" can easily lead to stent migration, failure to release the stent to the lesion, or insufficient anchoring area, resulting in surgical failure.

[0004] To address the above issues, a semi-release structure can be set on the aortic stent graft to gradually release the stent to avoid the "wind bag effect". In addition, when the stent is not attached to the wall, the axial position can be slightly adjusted to increase the accuracy of the stent release to the lesion location. However, during the delivery of the main thoracic stent, since the path of the delivery guide wire is close to the greater curvature side 901 of the blood vessel, if the limiting rod 73 is located on the lesser curvature side 902 of the blood vessel, as shown in FIG1 , when the limiting rod 73 is withdrawn to release the semi-constraint and completely release the stent, on the one hand, the withdrawal of the limiting rod is likely to cause the proximal end of the lesser curvature side of the stent to shift toward the distal end, thereby causing the proximal end to be poorly adhered to the wall after the coated stent is completely released, thereby causing internal leakage of the proximal end; on the other hand, especially for the distal end of the lesser curvature side of the stent, it will be pressed toward the greater curvature side by the limiting rod before the withdrawal of the limiting rod is completed, as shown in FIG1-2 , affecting the shape of the distal end stent before release. After the stent is released, the distal end of the stent is likely to be incompletely unfolded (the part pressed by the limiting rod in the local position), thereby easily forming uneven wrinkles at this location, resulting in a large gap between the uneven wrinkles and the blood vessel, as shown in FIG3 , which will seriously cause internal leakage of the distal end of the stent. Summary of the Invention

[0005] A technical problem solved by the present invention is how to provide a luminal stent to prevent the semi-constrained structure from causing poor adhesion of the distal end of the luminal stent to the wall and leading to internal leakage.

[0006] The present invention provides a luminal stent, which includes a stent body, a semi-release structure and a developing component. The semi-release structure includes a restraining unit and a restraining position. The luminal stent includes a first area and a second area along the circumferential direction. It is defined that when the luminal stent is naturally expanded, the area of ​​the luminal stent that can be crossed by the restraining unit in the circumferential direction is the first area, and the area that cannot be crossed by the restraining unit in the circumferential direction is the second area; the restraining position is set in the second area, and the developing component is used to indicate the position of the restraining position in the circumferential direction.

[0007] In one embodiment, the first area includes a first sub-area that is centrally symmetrical to the second area, and the developing assembly includes a first developing member.

[0008] The first developing member is disposed in the second area, and a central angle α between an axial line where the first developing member is located and an axial line where the restraining position is located satisfies the following conditions: 0°≤α≤45°;

[0009] Alternatively, the first developing member is provided in the first sub-region, and a central angle α1 between an axial line where the first developing member is located and an axial line where the restraining position is located satisfies: 135°≤α1≤180°;

[0010] Or the endoluminal support includes a second developing member, and a central angle α2 between an axial line where the second developing member is located and an axial line where the restraining position is located satisfies: 45°≤α2≤135°, and the second developing member is a non-axially symmetrical structure.

[0011] In one embodiment, the ratio of the central angle corresponding to the first area in the circumferential direction to the central angle corresponding to the second area in the circumferential direction is in the range of 1:1 to 4:1, and the central angle corresponding to the second area in the circumferential direction is defined as β, then β satisfies: 72°≤β≤180°; when β satisfies: 90°<β≤180°, the restraint position is set within the area range of ±45° of the angular mean line of the second area; when β satisfies: 72°≤β≤90°, the restraint position is set in the second area.

[0012] In one embodiment, the restraining position includes at least one limiting member, and when the endoluminal stent is radially compressed to a semi-constrained state, the restraining unit can pass through the limiting member;

[0013] At least one of the limiting members is on the same axial line as the first developing member;

[0014] Alternatively, at least one of the limiting members is closer to the middle position of the second area relative to the first developing member in the circumferential direction.

[0015] In one embodiment, there are multiple limit members, including a first limit member and a second limit member, and the circumferential deflection of the first limit member relative to the second limit member is less than or equal to 10°.

[0016] In one embodiment, the luminal stent also includes a coating covering the stent body, the developing assembly includes a first developing member, the first developing member is arranged in the second area, and the central angle between the axial line where the first developing member is located and the axial line where the restraint position is located is less than or equal to 45°; the luminal stent includes a second developing member, the second developing member is arranged on an axial line rotated 90° circumferentially from the first developing member, the first developing member is arranged at the proximal end of the stent body or the coating, and / or the second developing member is arranged at the distal end of the stent body or the coating.

[0017] In one embodiment, the first region further includes a first sub-region that is centrally symmetrical to the second region, and the endoluminal stent further includes a third developing member, and the circumferential position of the third developing member is centrally symmetrical to the position of the first developing member along the circumferential direction.

[0018] In one embodiment, the first developing member and the third developing member have different shapes, and the second developing member has an axially symmetrical structure or a non-axially symmetrical structure;

[0019] Alternatively, the first developing member and the third developing member have the same shape, and the second developing member is a non-axially symmetrical structure.

[0020] The present invention also provides a stent system, comprising a delivery device and a luminal stent as described above, characterized in that the delivery device comprises a sheath core assembly and a limiting rod, the restraining unit comprises a bundle diameter line and a locking assembly, the limiting rod can extend along the restraining position in the axial direction of the luminal stent, so that it can movably pass through the locking assembly to compress the luminal stent into the circumference formed by the bundle diameter line, so that the luminal stent is limited to a semi-constrained state.

[0021] In one embodiment, the semi-release structure further includes a limiting ring buckle, which is circumferentially arranged on the bracket body, and the restraining unit passes through the limiting ring buckle along the circumferential direction, so that the limiting ring buckle limits the axial position of the restraining unit.

[0022] A technical effect of an embodiment of the present invention is that the present invention can avoid placing the second area passed by the limiting rod on the small bend side of the blood vessel when the luminal stent is in a semi-released state to be released by setting a developing component to indicate the position of the restraint position in the circumferential direction, thereby avoiding internal leakage of the distal end. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG1 is a schematic diagram showing that the prior art cannot identify the circumferential position of the restraining position of the endoluminal stent, which may result in the restraining position being released on the lesser curvature side;

[0024] FIG2 is a cross-sectional view taken along the AA direction in FIG1 ;

[0025] FIG3 is a schematic diagram showing the adherence of the distal end of the luminal stent in the AA direction after the luminal stent in FIG1 is completely released;

[0026] FIG4 is a schematic structural diagram of the endoluminal stent provided by the present invention (natural expansion state);

[0027] FIG5 is a schematic structural diagram of the luminal stent after FIG4 is rotated 90° circumferentially (rotated 90° counterclockwise when viewed from the right to the left in FIG4 );

[0028] FIG6 is a schematic diagram of the circumferential region of the luminal stent with a restraining unit spanning the luminal stent as viewed from left to right in FIG5 (natural expansion state);

[0029] FIG7 is a schematic diagram of partitioning of the first area and the second area from the perspective of FIG6 ;

[0030] FIG8 is a schematic diagram of a ±45° region M of the angular mean line of the second region in FIG7 ;

[0031] FIG9 is a schematic diagram of the partitioning of the second area and the first sub-area from the perspective of FIG6 ;

[0032] FIG10 is a schematic structural diagram of the endoluminal stent (natural expansion state) provided by the present invention from another perspective;

[0033] FIG11 is a schematic diagram of a portion of the structure in FIG10 (showing a limit member);

[0034] FIG12 is a schematic structural diagram of the endoluminal stent provided by the present invention in a semi-constrained state;

[0035] FIG13 is a partial structural schematic diagram of FIG12 (showing the cooperation between the restraining unit and the limiting rod);

[0036] FIG14 shows the stent system provided by the present invention being transported to a predetermined position;

[0037] FIG15 shows the stent system provided by the present invention after the sheath is withdrawn, and the luminal stent is in a semi-constrained state;

[0038] FIG16 is an enlarged view of point E in FIG15 ;

[0039] FIG17 is a schematic diagram showing the endoluminal stent provided by the present invention being completely released at a predetermined position.

[0040] 100, luminal stent; 10, stent body; 111, wave-shaped ring; 111a, wave crest; 111b, wave trough; 111c, wave rod;

[0041] 20. Lamination;

[0042] 30. Semi-release structure; 31. Constraint unit; 311. Constraint line; 312. Locking buckle assembly; 3121. First locking buckle; 3122. Second locking buckle; 32. Positioning ring buckle; 33. Constraint position; 34. Middle fixing buckle;

[0043] 40. Developing member; 41. First developing member; 42. Second developing member; 43. Third developing member;

[0044] 100a, first area; 100b, second area; 100c, first sub-area;

[0045] 50. Naked wave circle;

[0046] 70. Delivery device; 71. Sheath core assembly; 72. Sheath tube; 73. Limit rod

[0047] L1, the axial line where the first developing member is located; L2, the axial line where the restraining position is located DETAILED DESCRIPTION

[0048] To facilitate understanding of the present invention, the present invention will be described more fully below with reference to the accompanying drawings. The accompanying drawings illustrate preferred embodiments of the present invention. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and comprehensive understanding of the present disclosure.

[0049] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly attached to the other element or there may be an intermediate element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.

[0050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used herein in the specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0051] "Axial" generally refers to the length of a medical device during delivery, while "radial" generally refers to the direction perpendicular to the device's "axial" direction. This principle is used to define the "axial" and "radial" directions of any medical device component. Furthermore, in interventional medicine, the proximal end of a stent, after deployment, is typically defined as the end closest to the heart, while the distal end is defined as the end farther from the heart.

[0052] The present invention provides a luminal stent 100, as shown in Figure 4-17, the luminal stent 100 includes a stent body 10, a coating 20, a semi-release structure 30, a restraining position 33, a developing part 40 and a bare wave ring 50. The stent body 10 includes a plurality of wavy rings 111 arranged at intervals along the axial direction, each wavy ring 111 includes a plurality of crests 111a and troughs 111b and a plurality of connecting rods respectively connecting adjacent crests 111a and troughs 111b. The coating 20 covers the plurality of wavy rings 111 of the stent body 10 to form a hollow tubular structure. The distal end of the bare wave ring 50 is connected to the proximal end of the coating 20, as shown in Figure 4-5; in other embodiments, the bare wave ring 50 may not be provided, and the stent may be directly semi-constrained and loaded into the loading position formed between the sheath core component 71 and the sheath tube 72, which is not limited here. It can be understood that multiple waveform rings 111 can have the same or similar waveform shapes, or can have waveform rings with different waveforms. The waveforms of the waveform rings 111 can be set as needed, and the number of waveforms and wave height in each waveform ring 111 can be set as needed.

[0053] As shown in Figures 4-5, the semi-release structure 30 includes a restraining unit 31, a limiting ring buckle 32 and a limiting member 330, and the restraining unit 31 passes through the limiting ring buckle 32 along the circumferential direction, wherein the restraining unit 31 includes a restraining line 311 and a locking assembly 312, and the locking assembly 312 is connected to the restraining line 311 and formed at both ends of the restraining line 311. In this embodiment, the binding wire 311 is a double-strand wire, and the locking assembly 312 is the folded end portion of the binding wire 311. In other embodiments, the binding wire 311 can also be two sections of double-strand wire extending from the middle axial line of the first area 100a toward the circumferential ends of the first area 100a, and an intermediate fixing buckle 34 is provided on the middle axial line of the first area 100a. The two sections of double-strand wire extend from the middle fixing buckle 34 along the circumferential direction toward the direction close to the second area 100b to the edge of the first area 100a, as shown in Figures 6-9. Providing the middle fixing buckle 34 on the middle axial line of the first area 100a can make the binding of the binding wire 311 more stable.

[0054] As shown in Figures 4-5, the limiting ring buckle 32 is circumferentially arranged on the bracket body 10 and can be fixed on the corrugated ring 111 or the covering 20. In this embodiment, multiple limiting ring buckles 32 are fixed at intervals along the circumference in the middle of some wave rods 111c of the corrugated ring 111 (a wave peak 111a is formed at the proximal end point between two adjacent wave rods 111c, and a limiting ring buckle 32 is provided on at least one wave rod 111c between two adjacent wave rods 111c). Each beam line 311 passes through the multiple limiting ring buckles 32 on the corresponding annular corrugated object in sequence along the circumferential direction, so that the limiting ring buckle 32 limits the beam line 311 to the middle area in the axial direction of the corrugated ring 111, preventing the corrugated ring 111 from being subjected to uneven radial constraint force, thereby facilitating the circumferential constraint of the bracket body 10 by the binding unit 31. The locking buckle assembly 312 includes a first locking buckle 3121 and a second locking buckle 3122 connected at both ends of the bundle warp line. The first locking buckle 3121 and the second locking buckle 3122 are both annular ends formed by folding the bundle warp line 311. After the luminal stent 100 is radially compressed, the first locking buckle 3121 passes through the limiting piece 330 of the second area 100b, and the limiting rod 73 of the conveying device 70 passes through the first locking buckle 3121 axially, limiting the first locking buckle 3121 at the position of the limiting piece 330. The limiting rod 73 also needs to pass through the second locking buckle 3122. After the luminal stent 100 is bundled to a semi-released state, it is radially compressed in the sheath 72.

[0055] As shown in Figures 6-9 in conjunction with Figures 10-13, the semi-release structure 30 can be used to constrain the circumference of the stent body 10. In this embodiment, the semi-release structure 30 is disposed on the outer surface of the luminal stent 100, as shown in Figure 6. When the sheath 72 is withdrawn to release the luminal stent 100 compressed in the delivery device 70 from the sheath 72, the radial constraint of the semi-release structure causes the luminal stent 100 to enter a semi-released state, as shown in Figures 12-13. At this time, the outer diameter of the luminal stent 100 is smaller than the inner diameter of the blood vessel due to the radial constraint, resulting in a lack of conformity to the inner wall of the blood vessel. Therefore, even in this semi-released state, the circumferential position of the restraining point 33 can still be determined based on the position of the developing assembly, allowing fine-tuning of the axial and circumferential positions of the luminal stent 100. Once both the axial and circumferential positions are adjusted to the desired positions, the radial constraint of the semi-release structure is released, and the luminal stent 100 moves from the semi-released state to the fully deployed state, where it adheres to the inner wall of the blood vessel.

[0056] The front, back, left, and right sides of the stent shown in Figures 4-9 are in opposite directions relative to the patient's front, back, and left and right directions, and are shown for the purpose of illustrating the stent's orientation. The side visible in Figure 4 (i.e., facing the reader on the page) is the back side, corresponding to the bottom (back side) of Figure 5 , and the side not visible in Figure 4 (i.e., the back side of the page) is the front side, corresponding to the top (front side) of Figure 5 . Similarly, the side visible in Figure 5 (i.e., facing the reader on the page) is the right side, corresponding to the top (right side) of Figure 4 , and the side not visible in Figure 5 (i.e., the back side of the page) is the left side, corresponding to the bottom (left side) of Figure 4 .

[0057] As shown in Figures 6-9, the endoluminal stent 100 includes a first area 100a and a second area 100b along the circumferential direction, wherein, when the endoluminal stent 100 is in a naturally expanded state, the area of ​​the endoluminal stent 100 that can be crossed by the restraining unit 31 in the circumferential direction is the first area 100a, and the area that cannot be crossed by the restraining unit 31 in the circumferential direction is the second area 100b; the developing assembly 40 includes a first developing member 41, and the first developing member 41 is arranged in the second area 100b, and the central angle α between the axial line L1 where the first developing member 41 is located and the axial line L2 where the restraining position 33 is located satisfies: 0°≤α≤45°, as shown in Figure 7; in other embodiments, as shown in Figure 9, the first area 100a includes a first sub-area 100c that is symmetrical to the center of the second area 100b, and the first developing member The central angle α1 between the axial line L1 where 41 is located and the axial line L2 where the restraint position 33 is located satisfies: 135°≤α1≤180°; wherein, the maximum value of α1 is 180°, so Figure 9 only shows that the first developing member is located at a lower position in the first sub-region 100c, so that the angle α1 formed is within the lower semicircle of Figure 9. In other embodiments, the first developing member can also be set at an upper position in the first sub-region 100c, so that the angle α1 formed is within the upper semicircle (figure omitted); the first developing member 41 can be set in the second region 100b or the first sub-region 100c, so as to distinguish the left and right sides of the luminal support 100, and the restraint position 33 is set on the same side or the opposite side of the first developing member 41, so that the first developing member 41 can be used to indicate the circumferential position of the restraint position 33.

[0058] Alternatively, the luminal stent 100 includes a second developing member 42, and the central angle α2 corresponding to the axial line of the second developing member 42 and the axial line L2 of the restraining position 33 satisfies the following: 45°≤α2≤135°. As shown in FIG8 , the second developing member 42 is a non-axially symmetrical structure to distinguish the front and rear orientations of the luminal stent 100, so that the restraining position 33 is located on a specific side of the second developing member 42 (e.g., the right side in FIG8 ). Thus, the second developing member 42 can be used to indicate the circumferential position of the restraining position 33. This can also prevent the luminal stent 100 from being placed in the lesser curvature of the blood vessel when the semi-released state is to be released, thereby preventing distal endoleakage. In addition, it can also avoid the problem of poor wall adhesion caused by the proximal end displacement of the stent on the lesser curvature side due to the withdrawal of the restraining rod, thereby preventing proximal endoleakage.

[0059] The first developing component 41 is arranged at the proximal end of the stent body 10 or the coating 20. Setting the developing component at the proximal end of the stent body 10 or the coating 20 can simultaneously indicate the position of the proximal end of the stent; the second developing component 42 is arranged at the proximal end or the distal end of the luminal stent 100. The second developing component 42 can be arranged on the stent body 10 or the coating 20. Only the first developing member 41 can be provided to distinguish the first side and the second side of the tubular stent 100; or only the second developing member 42 can be provided to distinguish the front and back of the tubular stent 100. When only the second developing member 42 is provided, the second developing member 42 needs to be a non-axially symmetrical structure to facilitate the distinction between the front and back of the tubular stent 100; the first developing member 41 and the second developing member 42 can also be provided at the same time. In other embodiments, the tubular stent 100 can also include a third developing member 43, the first developing member 41 is provided in the second area 100b, the third developing member 43 is symmetrical with the first developing member 41 along the circumferential direction, and / or the second developing member 42 is rotated 90° along the circumferential direction from the first developing member 41, wherein the second developing member 42 can be provided at the proximal end or distal end of the coating 20 by suturing.

[0060] When the first developing member 41 and the third developing member 43 have different shapes, they can distinguish between the left and right sides of the luminal stent 100, and the second developing member 42 can have an axially symmetrical or asymmetrical structure. When the first developing member 41 and the third developing member 43 have the same shape, the second developing member 42 needs to have an asymmetrical structure to distinguish between the front and back sides of the luminal stent 100. This also allows the second region 100b to be placed against the greater curvature of the blood vessel when the luminal stent 100 is implanted in a blood vessel to release the restraints of the semi-release structure 30 of the luminal stent 100, allowing the luminal stent 100 to be fully released. In one embodiment, the asymmetrical structure of the second developing member 42 can be a recognizable pattern with a closed asymmetrical structure, such as a "6," a "G," or a "9."

[0061] As shown in Figures 4-5 in combination with Figures 10-13, in this embodiment, the luminal stent 100 includes a first developing part 41, a second developing part 42 and a third developing part 43. The first developing part 41 and the third developing part 43 are arranged at the proximal end of the covering 20, and the second developing part 42 is arranged at the distal end of the covering 20, and each developing part can be fixed to the covering 20 by suturing. The first developing member 41 and the second developing member 42 have different shapes. The first developing member 41 is arranged in the second area 100b. The first developing member 41 can be set to an "8" shape. Multiple limiting members 330 form an axial restraining position 33 along the axial direction, and are sequentially arranged on the middle axial line of the second area 100b, thereby forming an axial line L2 where the restraining position 33 is located. In this embodiment, the first developing member is also arranged on the middle axial line of the second area 100b, so the middle axial line of the second area 100b is the axial line L1 where the first developing member 41 is located, that is, the axial line L1 where the first developing member 41 is located and the axial line L2 where the restraining position 33 is located are on the same axial line, that is, in this embodiment, α=0°, as shown in Figure 10. The first developing member 41 and the limiting member 330 are arranged on the same axial line (or the first developing member 41 is deflected by no more than 10° relative to the axial line where the limiting member 330 is located), and the first developing member 41 is sewn to the proximal end of the coating 20; the limiting member 330 is configured as a suture buckle, which is sewn to the coating 20 at the middle position of the wave rod 111c of its corresponding corrugated ring 111 or is directly sewn to the coating 20 next to the middle position of the wave rod 111c without going around the wave rod 111c, and a gap is left for the binding unit 31 to pass through. The third developing member 43 can be set to a "0" shape, and is symmetrical with the first developing member 41 along the circumferential direction. The different structures of the first developing member 41 and the second developing member 42 can distinguish the left and right directions (first side and second side) of the luminal stent 100; the second developing member 42 can be set to a "0" shape, and the second developing member 42 is set at the distal end of the coating 20 of the luminal stent 100, and the second developing member 42 is rotated 90° along the circumferential direction from the first developing member 41. Under the developing viewing angle shown in Figure 4, the second developing member 42 is located on the perpendicular midline of the line connecting the first developing member 41 and the third developing member 43, and can form a three-dimensional structure between the first developing member 41 and the third developing member 43, so as to facilitate the judgment of whether the distal end of the stent is evenly expanded in the circumferential direction after the luminal stent 100 is fully released. In other embodiments, only the first developing component 41 may be provided, or only the second developing component 42 with a non-axially symmetrical structure may be provided. It is only necessary for the developing component to indicate the circumferential position of the restraining position 33, so that the luminal stent 100 in a semi-restrained state can be circumferentially adjusted so that the restraining position 33 fits the greater curvature of the blood vessel. No limitation is imposed here.

[0062] Generally, the two ends of the restraining unit 31 are releasably restrained to the restraining position 33, thereby achieving semi-releasable restraint of the stent body 10 by the semi-release structure 30 in the circumferential direction. When a limiting rod 73 is provided in the delivery device 70 to restrain the restraining unit 31, the limiting rod 73 is generally axially disposed at the restraining position 33 within the second region 100b, so that the two ends of the binding line 311 are restrained within the second region 100b, thereby compressing the radial direction of the luminal stent 100. In this embodiment, the locking components 312 at both ends of the binding line 311 are close to each other at the middle position of the second region 100b, and the limiting rod 73 passes through the locking components 312 at both ends to compress the corrugated ring 111 of the luminal stent 100. The limiting rod 73 sequentially passes through the locking components 312 at both ends of the binding line 311 corresponding to each corrugated ring, thereby compressing the radius of the luminal stent 100 as a whole to a semi-constrained state. The luminal stent 100 further includes a first side and a second side along the circumferential direction, the first side and the second side each occupy 180° in the circumferential direction, and the second region 100b is located within the range of the ±45° region M of the angular mean line of the first side, wherein the first side of the luminal stent is located on the greater curvature side of the aortic arch when implanted in the blood vessel, and the second side is located on the lesser curvature side of the aortic arch when implanted in the blood vessel, and the setting of the developing component can be used to indicate the position of the restraint position 33 in the circumferential direction, so that the first side and the second side of the luminal stent 100 can be distinguished during the implantation process of the luminal stent 100, and when adjusting the circumference of the luminal stent 100 in the semi-released state, the restraint position 33 of the second region 100b can be made to correspond to the greater curvature side of the blood vessel, so that the luminal stent 100 can be released when the semi-released state is released. During the process, the second area 100b thereof is attached to the greater curvature side of the blood vessel, so that the limiting rod 73 is attached to the greater curvature side and withdrawn, preventing the proximal end of the second side of the stent from shifting toward the distal end when the withdrawn limiting rod 73 is released from the semi-released state, thereby causing the proximal end of the coated stent 20 to be poorly adhered to the wall after the stent is fully released, thereby causing internal leakage of the proximal end; on the other hand, it can also prevent the distal end of the second side of the luminal stent 100 from being pressed toward the greater curvature side by the limiting rod 73 before the limiting rod 73 is completely withdrawn, so as to ensure that the distal end of the luminal stent 100 has a good shape in the semi-released state, and avoid the distal end of the second side of the luminal stent 100 from being easily unfolded after the stent is released, thereby avoiding the formation of uneven wrinkles and thus avoiding internal leakage of the distal end of the stent.

[0063] It is understood that if the circumscribed diameter of the cross-section of the luminal stent 100 is too large when in the semi-released state, the luminal stent 100 will easily stick to the inner wall of the blood vessel in the semi-released state, making it difficult to adjust the axial and circumferential positions. If the circumscribed diameter of the cross-section of the luminal stent 100 is too small when in the semi-released state, even if the circumferential or axial position is adjusted, after the semi-released state is released, due to the large radial change of the stent, there may still be large circumferential and axial positioning deviations, making the semi-release structure 30 less effective. In this embodiment, the ratio of the circumscribed diameter of the cross-section of the luminal stent 100 in the semi-released state to the circumscribed diameter of the cross-section of the luminal stent 100 when naturally expanded is 0.5 to 0.8.

[0064] Since the circumference of the cross-section in the semi-released state is the circumferential length of the beam line 311, the ratio of the circumscribed diameter of the cross-section of the luminal stent 100 in the semi-released state to the circumscribed diameter of the cross-section of the luminal stent 100 when it is naturally expanded is equal to the ratio of the central angle corresponding to the first area 100a in the circumferential direction to the 360-degree angle of the circumference. When the ratio of the circumscribed diameter of the cross-section of the luminal stent in the semi-released state to the circumscribed diameter of the cross-section of the luminal stent when it is naturally expanded is 0.5, the central angle corresponding to the first area in the circumferential direction is 180°; when the ratio of the circumscribed diameter of the cross-section of the luminal stent in the semi-released state to the circumscribed diameter of the cross-section of the luminal stent when it is naturally expanded is 0.8, the central angle corresponding to the first area in the circumferential direction is 288°, and the central angle corresponding to the second area in the circumferential direction is 72°. The central angle spanned by the second region 100b is defined as β, as shown in FIG7 , and the central angle corresponding to the circumferential direction of the first region 100a is equal to 360°-β, wherein β satisfies: 72°≤β≤180°; when β satisfies: 90°<β≤180°, the first developing member 41 is arranged within the range of the ±45° region M of the angular mean line of the second region 100b or the first subregion 100c; when α satisfies: 72°≤β≤90°, the first developing member 41 is arranged in the second region 100b or the first subregion 100c to distinguish the first side and the second side of the luminal stent 100, and the limiting rod 73 in the second region 100b is closer to the middle position of the first side, so that when the luminal stent 100 is in a semi-released state, with the help of the indication of the developing assembly 40, the limiting rod 73 located at the restraining position 33 is closer to the greater curvature side of the blood vessel.

[0065] The restraining position 33 of the luminal stent includes at least one limiter 330, which can be used to limit the limiter rod 73 to the restraining position. In this embodiment, the restraining position 33 of the luminal stent 100 includes multiple limiters, which are axially arranged in the second area 100b. The limiters are generally arranged in the range of ±45° area M of the angular mean line of the second area 100b. The circumferential distances of the locking components 312 at both ends of the bundle diameter line 311 are equal or approximately equal, so that when the luminal stent 100 is in a semi-released state, the limiter rod 73 in the second area 100b is closer to the middle position of the greater bend of the blood vessel. When the luminal stent 100 is radially compressed to a semi-constrained state, one end of the restraining unit 31 can pass through the limiter, and then the limiter rod 73 is passed through the locking components 312 at both ends of the restraining unit 31 in turn. The number of limiters can be specifically determined based on the number of the wavy rings 111 of the stent and the degree to which the semi-constraint is desired to be extended in the axial direction. Multiple limiters are spaced axially to form the constraint position 33. The central angle between the axial line where the limiter is located and the axial line L1 where the first developing member 41 is located is α, and the limiter is circumferentially closer to the middle position of the second area 100b relative to the first developing member 41. When the luminal stent 100 is radially compressed and converged to a semi-released state, the locking assembly 312 at one end of the bundle line 311 passes through the limiter at its corresponding position circumferentially, and then the limiter rod 73 passes through the locking assembly 312, so that the limiter limits the circumferential position of the limiter rod 73, thereby limiting the limiter rod 73 at the position of the limiter, as shown in Figure 13. When α=0°, the limiter and the first developing member 41 are on the same axial line L1, as shown in Figure 10-11 combined with Figure 12-13, and multiple limiters are axially arranged on the left and right sides of the middle axial line L1 of the second area 100b within a range of 10° on each side. In one embodiment, the limiter and the first developing member 41 are both located on the middle axial line of the second area 100b, so that the circumferential distance between the limiter and the locking assembly 312 at both ends of the bundle diameter line 311 is approximately equal, so that when the luminal support 100 is in a semi-released state, the compression state of the luminal support 100 is uniform and the semi-constrained state is more stable.

[0066] Multiple limit members can be arranged in sequence along the same axial line on each corrugated ring 111 or on the coating 20 corresponding to the middle position of its wave rod 111c, and can also be slightly deflected relatively, as long as it does not affect the uniform compression and release of the semi-constraint. No limitation is made here. The limit members include a first limit member and a second limit member. It is only necessary that the central angle of the axial line where any limit member (constraint position 33) is located and the axial line L1 where the first developing member 41 is located satisfies the said α, and the circumferential deflection of the first limit member relative to the second limit member is less than or equal to 10°, so that the limit rod 73 is roughly along the axial direction.

[0067] The present invention also provides a stent system, including a delivery device 70 and a luminal stent 100 as described above, wherein the delivery device 70 includes a sheath core assembly 71, a sheath tube 72 and a limiting rod 73, wherein the limiting rod 73 extends axially along the second region 100b and is movably connected to the locking assembly 312, and the luminal stent 100 is radially compressed in the loading interval formed between the sheath tube 72 and the sheath core assembly 71.

[0068] Taking the implantation of the main thoracic stent system as an example, as shown in Figures 14-17, when the stent system is delivered to the predetermined position, the sheath 72 is withdrawn, and the luminal stent 100 is not completely released to a semi-released state due to the effect of the semi-constrained structure, which can prevent the wind bag effect. As shown in Figure 15, the axial position of the luminal stent 100 can also be fine-tuned to make the release position of the luminal stent 100 more accurate. At the same time, according to the position of the first developing member 41, the circumferential position of the luminal stent 100 is adjusted so that the side where the limiting rod 73 of the stent system is located is close to the greater curvature side of the blood vessel. As shown in Figures 15-16, the proximal end of the small curve side of the stent is prevented from shifting toward the distal end due to the release of the semi-constraint by withdrawing the limit rod 73, thereby preventing internal leakage caused by poor adhesion of the proximal end of the luminal stent 100 to the wall; on the other hand, it can also prevent the limit rod 73 from pressing against the distal end of the small curve side of the luminal stent 100 on the small curve side, thereby preventing the distal end of the small curve side of the luminal stent 100 from being in a state of being recessed toward the large curve side before the stent is released, thereby preventing the distal end of the stent from expanding unevenly after the stent is completely released, and further preventing internal leakage of the distal end of the stent. After the limit rod 73 is retracted, the semi-constrained state is released and the luminal stent 100 is fully released, as shown in Figure 17. In this embodiment, when the luminal stent 100 is fully released, the midline L3 (i.e., the center line of the blood vessel) of the first developing component 41 and the third developing component 43 is defined, and it is also possible to judge whether the distal end of the luminal stent 100 is evenly unfolded based on the position of the second developing component 42 relative to the midline L3 of the first developing component 41 and the third developing component 43.

[0069] In other embodiments, the limiting rod 73 can also pass through the limiting member, so that the limiting member limits the limiting rod 73 on the axial line where the limiting member is located (i.e., the restraining position), and the limiting rod 73 also passes through the first lock buckle 3121 and the second lock buckle 3122. At the same time, the first lock buckle 3121 and the second lock buckle 3122 are limited on the axial line where the limiting member is located, and the contraction of the semi-restrained structure can also be achieved. No limitation is made here. It is only necessary for at least one of the lock buckle assembly 312 or the limiting rod 73 to pass through the limiting member to realize that the setting position of the limiting member is the restraining position 33.

[0070] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0071] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A lumen stent, characterized in that, The lumen stent includes a stent body, a semi-release structure, and a developing component. The semi-release structure includes a binding unit and a binding position. The lumen stent includes a first region and a second region in the circumferential direction. It is defined that in the state of natural expansion of the lumen stent, the region that can be spanned by the binding unit in the circumferential direction of the lumen stent is the first region, and the region that cannot be spanned by the binding unit in the circumferential direction is the second region; the binding position is arranged in the second region, and the developing component is used to indicate the position of the binding position in the circumferential direction.

2. The lumen stent according to claim 1, characterized in that, There is a first sub-region in the first region that is centrosymmetric with the center of the second region. The developing component includes a first developing element. The first developing element is arranged in the second region. The central angle α between the axial line where the first developing element is located and the axial line where the binding position is located satisfies: 0°≤α≤45°. Or, the first developing element is arranged in the first sub-region. The central angle α1 between the axial line where the first developing element is located and the axial line where the binding position is located satisfies: 135°≤α1≤180°. Or the lumen stent includes a second developing element. The central angle α2 between the axial line where the second developing element is located and the axial line corresponding to the binding position satisfies: 45°≤α2≤135°. The second developing element is a non-axially symmetric structure.

3. The luminal stent according to claim 2, wherein The ratio range of the central angle corresponding to the first region in the circumferential direction to the central angle corresponding to the second region in the circumferential direction is 1:1 to 4:

1. Define the central angle corresponding to the second region in the circumferential direction as β, then β satisfies: 72°≤β≤180°; when β satisfies: 90°<β≤180°, the binding position is arranged within the range of ±45° of the angular bisector of the second region; when β satisfies: 72°≤β≤90°, the binding position is arranged in the second region.

4. The luminal stent according to claim 2, wherein The binding position includes at least one limiting element. When the lumen stent is radially compressed to a semi-bound state, the binding unit can pass through the limiting element. At least one of the limiting elements is on the same axial line as the first developing element. Or, at least one of the limiting elements is closer to the middle position of the second region than the first developing element in the circumferential direction.

5. The lumen stent according to claim 4, characterized in that, The number of the limiting elements is multiple. The multiple limiting elements include a first limiting element and a second limiting element, and the circumferential deflection of the first limiting element relative to the second limiting element is less than or equal to 10°.

6. The lumen stent according to claim 1, wherein The lumen stent further includes a film covering the stent body. The developing component includes a first developing element. The first developing element is arranged in the second region. The central angle between the axial line where the first developing element is located and the axial line where the binding position is located is less than or equal to 45°; the lumen stent includes a second developing element. The second developing element is arranged on the axial line rotated 90° in the circumferential direction from the first developing element. The first developing element is arranged at the proximal end of the stent body or the film, and / or the second developing element is arranged at the distal end of the stent body or the film.

7. The lumen stent according to claim 6, characterized in that, The first region further includes a first sub-region that is centrosymmetric with the center of the second region, and the lumen stent further includes a third developer. The circumferential position of the third developer is circumferentially centrosymmetric with the position of the first developer.

8. The lumen stent according to claim 7, wherein, The first developer and the third developer have different shapes, and the second developer is an axially symmetric structure or a non-axially symmetric structure; Or, the first developer and the third developer have the same shape, and the second developer is a non-axially symmetric structure.

9. A stent system, comprising a delivery device and a luminal stent according to any one of claims 1-8, characterized in that, The delivery device includes a sheath-core assembly and a limiting rod, and the binding unit includes a diameter-binding wire and a locking component. The limiting rod can extend axially along the binding position on the lumen stent, so as to movably pass through the locking component to compress the lumen stent within the circumference formed by the diameter-binding wire, so that the lumen stent is restricted to a semi-bound state.

10. The stent system according to claim 9, wherein, The semi-release structure further includes a limiting loop buckle. The limiting loop buckle is circumferentially arranged on the stent body, and the binding unit passes through the limiting loop buckle circumferentially, so that the limiting loop buckle defines the axial position of the binding unit.

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