CN120203865B

CN120203865B - Lumen stents and stent systems

Info

Publication number: CN120203865B
Application number: CN202311838045.1A
Authority: CN
Inventors: 林志鹏; 王婉
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2023-12-27
Filing date: 2023-12-27
Publication date: 2026-03-17
Anticipated expiration: 2043-12-27
Also published as: CN120203865A; WO2025139448A1

Abstract

This invention relates to a luminal stent, comprising a stent body, a semi-release structure, and a contrast-enhancing component. The semi-release structure includes a restraint unit and a restraint position. The luminal stent includes a first region and a second region circumferentially. In its naturally expanded state, the first region is defined as the area circumferentially traversable by the restraint unit, and the second region is defined as the area circumferentially inaccessible by the restraint unit. The restraint position is located in the second region, and the contrast-enhancing component indicates the circumferential position of the restraint position. By providing a contrast-enhancing component to indicate the circumferential position of the restraint position, this invention prevents the second region, through which the restraining rod passes, from being positioned on the lesser curvature of the vessel when the luminal stent is in a semi-released state awaiting release, thus avoiding distal endoleak.

Description

Lumen stent and stent system

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a lumen stent and a stent system.

Background

Aortic aneurysms and aortic dissection are diseases which seriously endanger the life safety of human beings at present, if the aortic aneurysms and dissection are not actively treated, the aortic aneurysms and dissection are continuously increased, and finally are ruptured to cause serious complications and death, and along with the continuous increase of patients suffering from hypertension, hyperlipidemia and hyperglycemia, the incidence of the aortic aneurysms and aortic dissection is also obviously increased at present. The traditional open surgery treatment aortic aneurysm and aortic dissection has the characteristics of large trauma, high mortality rate, long surgery time, high postoperative complication occurrence rate and high surgery difficulty, while the intracavity treatment has the characteristics of small trauma, less postoperative complication, short surgery time, low surgery difficulty and the like, so that the traditional open surgery treatment aortic aneurysm and aortic dissection gradually becomes the main mode for treating aortic aneurysm and aortic dissection at present. The covered stent is implanted in the aorta to isolate vascular lesions outside the covered stent, so that blood flow is restrained from flowing through the covered stent, and the purpose of protecting blood vessels is achieved.

In the implantation process of the covered stent, the condition that the stent is partially adhered but not completely released often occurs, and the 'wind pocket effect' is easy to occur, wherein the wind pocket effect refers to that the proximal end of the stent is adhered, the distal end is not released yet and blocks the blood passage, the heart pumps blood continuously along with the time, so that more and more blood is blocked at the position where the stent is located, and the stent is in the same pocket of swelling. The formation of the "windbag effect" is very dangerous for the operation because blocking the blood flow, the heart pumps blood continuously, causing the blood pressure to rise continuously, the blood vessel to rupture and the heart to overload, leading to serious death of the patient. The "ballooning effect" is likely to cause stent displacement, failure to release the stent to the lesion site, or insufficient anchoring area resulting in failure of the procedure.

Aiming at the problems, the 'wind pocket effect' can be avoided by arranging the semi-release structure on the aortic tectorial membrane stent to gradually release the stent, and the stent can also slightly adjust the axial position under the condition of no adherence so as to increase the accuracy of the stent released to the lesion position. However, in the process of conveying the main chest stent, as the path of the conveying guide wire is tightly attached to the large curved side 901 of the blood vessel, if the limiting rod 73 is located on the small curved side 902 of the blood vessel, as shown in fig. 1, when the stent is completely released by withdrawing the limiting rod 73, on one hand, the proximal end of the small curved side of the stent is easily displaced towards the distal end due to the withdrawing of the limiting rod, so that the proximal end of the covered stent is not adhered well after being completely released, and further, the proximal end is leaked inwards, on the other hand, particularly for the distal end of the small curved side of the stent, the distal end of the stent is pressed towards the large curved side by the limiting rod before being formed, as shown in fig. 1-2, the shape before the release of the distal end of the stent is affected, and uneven wrinkles are easily formed at the distal end of the stent (the part pressed by the limiting rod in the local position) so that a large gap is formed between the uneven wrinkles at the position and the blood vessel, as shown in fig. 3, and the distal end of the stent is seriously leaked inwards.

Disclosure of Invention

The invention solves the technical problem of how to provide a lumen stent, which prevents the inner leakage caused by poor adherence of the distal end of the lumen stent due to a semi-binding structure.

The invention provides a lumen stent which comprises a stent main body, a semi-release structure and a developing assembly, wherein the semi-release structure comprises a constraint unit and a constraint position, the lumen stent comprises a first area and a second area along the circumferential direction, the area which can be spanned by the constraint unit in the circumferential direction of the lumen stent in a natural expansion state of the lumen stent is defined as the first area, the area which cannot be spanned by the constraint unit in the circumferential direction is defined as the second area, the constraint position is arranged in the second area, and the developing assembly is used for indicating the position of the constraint position along the circumferential direction.

In one embodiment, the first region has a first sub-region therein that is centrally symmetric with respect to the second region, the developing assembly includes a first developing member,

The first developing part is arranged in the second area, and the central angle alpha of the axial line where the first developing part is positioned and the axial line where the binding position is positioned meets the conditions that alpha is more than or equal to 0 degree and less than or equal to 45 degrees;

or the first developing part is arranged in the first subarea, and the central angle alpha 1 of the axial line of the first developing part and the axial line of the binding position is 135 degrees or more and alpha 1 or less than 180 degrees;

Or the lumen stent comprises a second developing part, wherein the central angle alpha 2 of the axial line of the second developing part corresponding to the axial line of the binding position is more than or equal to 45 degrees and less than or equal to 135 degrees, and the second developing part is of a non-axial symmetrical structure.

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 1:1-4:1, the central angle corresponding to the second area in the circumferential direction is defined as beta, beta is 72 degrees or more and is less than or equal to 180 degrees, when beta is 90 degrees or less and is less than or equal to 180 degrees, the constraint position is arranged in the area range of +/-45 degrees of the angle average line of the second area, and when beta is 72 degrees or less and is less than or equal to 90 degrees, the constraint position is arranged in the second area.

In one embodiment, the tie down site includes at least one stop through which the tie down unit may pass when the luminal stent is radially compressed to a semi-tie down state;

at least one limiting piece and the first developing piece are on the same axial line;

Or, at least one of the spacing members is located closer to an intermediate position of the second region in the circumferential direction with respect to the first developing member.

In one embodiment, the number of the limiting members is a plurality, the plurality of limiting members comprises a first limiting member and a second limiting member, and the deflection of the first limiting member relative to the second limiting member in the circumferential direction is less than or equal to 10 degrees.

In one embodiment, the lumen stent further comprises a coating film coated on the stent main body, the developing assembly comprises a first developing part, the first developing part is arranged in the second area, the central angle between the axial line where the first developing part is positioned and the axial line where the binding position is positioned is smaller than or equal to 45 degrees, the lumen stent comprises a second developing part, the second developing part is arranged on the axial line which rotates by 90 degrees along the circumferential direction from the first developing part, the first developing part is arranged at the proximal end of the stent main body or the coating film, and/or the second developing part is arranged at the distal end of the stent main body or the coating film.

In one embodiment, the first region further includes a first sub-region that is centrally symmetric to the second region, and the lumen stent further includes a third developing member, and a circumferential position of the third developing member is centrally symmetric to a position of the first developing member in a circumferential direction.

In one embodiment, the first developing member and the third developing member are different in shape, and the second developing member is of an axially symmetrical structure or a non-axially symmetrical structure;

Or the first developing part and the third developing part are the same in shape, and the second developing part is of a non-axial symmetrical structure.

The invention also provides a stent system, which comprises a conveying device and the lumen stent, and is characterized in that the conveying device comprises a sheath core assembly and a limiting rod, the constraint unit comprises a beam diameter line and a lock catch assembly, and the limiting rod can extend along the constraint position in the axial direction of the lumen stent so as to movably penetrate through the lock catch assembly to compress the lumen stent into the circumference formed by the beam diameter line, so that the lumen stent is limited to a half constraint state.

In one embodiment, the half release structure further includes a stop collar disposed circumferentially on the bracket body, and the restraint unit passes circumferentially through the stop collar such that the stop collar defines an axial position of the restraint unit.

The technical effect of one embodiment of the invention is that the developing component is used for indicating the position of the binding position in the circumferential direction, so that the condition that the second area penetrated by the limiting rod is placed at the small-curve side of the blood vessel under the condition that the semi-release state of the lumen stent is to be released can be avoided, and the inner leakage of the distal end can be avoided.

Drawings

FIG. 1 is a schematic view of a prior art system in which failure to identify the circumferential location of a constrained position of a lumen stent may result in release of the constrained position on the side of a small curve;

FIG. 2 is a cross-sectional view taken along the direction A-A in FIG. 1;

FIG. 3 is a schematic illustration of the attachment of the distal end of the lumen stent in the A-A direction after the lumen stent of FIG. 1 has been fully released;

FIG. 4 is a schematic view of a lumen stent according to the present invention (natural expanded state);

FIG. 5 is a schematic view of the lumen stent of FIG. 4 rotated 90 circumferentially (rotated 90 counterclockwise as viewed from the right to the left in FIG. 4);

FIG. 6 is a schematic view of the tethering unit across a circumferential region of the luminal stent from the left-to-right view in FIG. 5 (natural expanded state);

FIG. 7 is a schematic view of a first region and a second region from the perspective of FIG. 6;

FIG. 8 is a schematic view of the region M of + -45 DEG of the angular average line of the second region of FIG. 7;

FIG. 9 is a schematic view of a partition of the second region and the first sub-region from the perspective of FIG. 6;

FIG. 10 is a schematic view of another view of a lumen stent (natural expanded state) according to the present invention;

FIG. 11 is a schematic view of a portion of the structure of FIG. 10 (showing the stop member);

FIG. 12 is a schematic view of a lumen stent according to the present invention in a semi-constrained state;

FIG. 13 is a schematic view of a portion of the structure of FIG. 12 (showing the engagement of the binding unit with the stop lever);

FIG. 14 is a schematic view of a stent system of the present invention being delivered to a predetermined location;

FIG. 15 shows a lumen stent in a semi-constrained state after sheath withdrawal in the stent system provided by the present invention;

fig. 16 is an enlarged view at E in fig. 15;

fig. 17 is a schematic view of a lumen stent provided by the present invention fully released at a predetermined position.

100. Lumen stent 10, stent body 111, wave ring, 111a, wave crest, 111b, wave trough, 111c, wave pole;

20. coating a film;

30. Semi-release structure, 31, binding unit, 311, binding wire, 312, lock catch assembly, 3121, first lock catch, 3122, second lock catch, 32, limit ring buckle, 33, binding position, 34, middle fixing buckle;

40. Developing member 41, first developing member 42, second developing member 43, third developing member;

100a, a first region, 100b, a second region, 100c, a first sub-region;

50. A bare wave ring;

70. Conveying device, 71 sheath core assembly, 72 sheath tube, 73 limit rod

L1, the axial line of the first developing part, L2, the axial line of the binding position

Detailed Description

In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. The drawings illustrate preferred embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "fixed to" 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 "inner", "outer", "left", "right" and the like are used herein for illustrative purposes only and do not represent the only embodiment.

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

"Axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle. In addition, in the field of interventional medicine, it is generally defined that the end of the lumen stent that is proximal to the heart after release is the proximal end and the end distal to the heart is the distal end.

The invention provides a lumen stent 100, as shown in fig. 4-17, the lumen stent 100 comprises a stent main body 10, a covering film 20, a half release structure 30, a binding position 33, a developing part 40 and a bare wave ring 50, wherein the stent main body 10 comprises a plurality of wavy annular objects 111 which are arranged at intervals along the axial direction, each wavy annular object 111 comprises a plurality of wave crests 111a and wave troughs 111b and a plurality of connecting rods which respectively connect adjacent wave crests 111a and wave troughs 111b, the covering film 20 is covered on the wavy annular objects 111 of the stent main body 10 to form a hollow lumen structure, the distal end of the bare wave ring 50 is connected with the proximal end of the covering film 20, as shown in fig. 4-5, in other embodiments, the bare wave ring 50 can be directly and half bound and then be loaded at a loading position formed between a sheath core assembly 71 and a sheath tube 72, and the invention is not limited. It is understood that the waveform rings 111 may have the same or similar waveform shape, or may have different waveforms, the waveform of the waveform ring 111 may be set according to the requirement, and the number of waveforms, wave heights, etc. in each waveform ring 111 may be set according to the requirement.

As shown in fig. 4-5, the semi-release structure 30 includes a restraint unit 31, a stop collar 32 and a stop member 330, wherein the restraint unit 31 passes through the stop collar 32 along the circumferential direction, the restraint unit 31 includes a wire harness 311 and a latch assembly 312, and the latch assembly 312 is connected with the wire harness 311 and formed at two ends of the wire harness 311. In this embodiment, the harness 311 is a double-stranded wire, the latch assembly 312 is a folded end of the harness 311, and in other embodiments, the harness 311 may be two double-stranded wires extending from a middle axial line of the first region 100a toward two circumferential ends of the first region 100a, the middle fixing buckle 34 is disposed on the middle axial line of the first region 100a, and the two double-stranded wires extend from the middle fixing buckle 34 to an edge of the first region 100a in a direction approaching to the second region 100b in the circumferential direction, as shown in fig. 6-9, and the middle fixing buckle 34 is disposed on the middle axial line of the first region 100a, so that the restraint of the harness 311 is more stable.

As shown in fig. 4 to 5, the retaining ring 32 is circumferentially disposed on the bracket body 10 and may be fixed on the wavy annular object 111 or on the covering film 20, in this embodiment, the plurality of retaining rings 32 are circumferentially fixed at intervals in the middle of a portion of the wavy annular object 111c (a peak 111a is formed at a proximal end point between two adjacent wavy rods 111c, and the retaining ring 32 is disposed on at least one wavy rod 111c between two adjacent wavy rods 111 c), and each wire harness 311 sequentially passes through the plurality of retaining ring 32 on the corresponding wavy annular object along the circumferential direction, so that the retaining ring 32 limits the wire harness 311 in an intermediate region in the axial direction of the wavy annular object 111, preventing uneven radial constraint stress of the wavy annular object 111, thereby facilitating circumferential constraint of the bracket body 10 by the constraint unit 31. The latch assembly 312 includes a first latch 3121 and a second latch 3122 connected at two ends of the binding thread, the first latch 3121 and the second latch 3122 are annular ends formed by folding the binding thread 311, after the lumen stent 100 is radially compressed, the first latch 3121 passes through the limiting member 330 of the second region 100b, the limiting rod 73 of the conveying device 70 passes through the first latch 3121 axially, the first latch 3121 is limited at the position of the limiting member 330, the limiting rod 73 also passes through the second latch 3122, and after the lumen stent 100 is bound to the semi-release state, the lumen stent is radially compressed in the sheath 72.

As shown in fig. 6-9 in combination with fig. 10-13, the semi-release structure 30 may 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 fig. 6. When the sheath 72 is withdrawn to release the luminal stent 100 compressed in the delivery device 70 from the sheath 72, the luminal stent 100 is in a semi-released state due to the radial constraint of the semi-released structure, as shown in fig. 12-13, in which the outer diameter of the luminal stent 100 is less than the inner diameter of the vessel due to the radial constraint, and thus does not conform to the inner wall of the vessel. Therefore, in the half-released state of the lumen stent 100, the circumferential position of the binding site 33 can still be determined according to the position of the developing assembly, so that the axial and circumferential positions of the lumen stent 100 can be finely adjusted, and after the axial and circumferential positions are adjusted to the desired positions, the radial constraint of the half-binding structure is released, and the lumen stent 100 is from the half-released state to the fully-deployed state and is attached to the inner wall of the blood vessel.

Wherein the anterior, posterior, left, and right sides of the stent are shown in opposite orientations from the anterior, posterior, left, and right sides of the patient, the illustrations are for convenience only in describing the orientation of the stent. The side that is visible in fig. 4 (i.e., on the page facing the reader) is the rear side, corresponding to the lower side (rear side) of fig. 5, and the side that is not visible in fig. 4 (i.e., on the back of the page) is the front side, corresponding to the upper side (front side) of fig. 5. Similarly, the side that is visible in fig. 5 (i.e., the upper side of the paper facing the reader) is the right side, which corresponds to the upper side (right side) of fig. 4, and the side that is not visible in fig. 5 (i.e., the back side of the paper) is the left side, which corresponds to the lower side (left side) of fig. 4.

As shown in fig. 6 to 9, the lumen stent 100 includes a first region 100a and a second region 100b in the circumferential direction, wherein it is defined that when the lumen stent 100 is in a natural expanded state, a region of the lumen stent 100 that can be spanned by the binding unit 31 in the circumferential direction is the first region 100a, and a region of the lumen stent that cannot be spanned by the binding unit 31 in the circumferential direction is the second region 100b; the developing assembly 40 includes a first developing member 41, the first developing member 41 is disposed in the second area 100b, the central angle α of the axial line L1 of the first developing member 41 and the axial line L2 of the binding position 33 is smaller than or equal to 0 ° and smaller than or equal to 45 °, as shown in fig. 7, in other embodiments, as shown in fig. 9, the first area 100a includes a first sub-area 100c that is centrally symmetrical to the second area 100b, the central angle α 1 of the axial line L1 of the first developing member 41 and the axial line L2 of the binding position 33 is smaller than or equal to 135 ° and smaller than or equal to 180 °, where the maximum value of α1 is 180 °, so fig. 9 only shows that the first developing member is located at a position in the lower part of the first sub-area 100c, so that the formed α1 angle is within the lower semicircle of fig. 9, in other embodiments, the first developing member may also be disposed at a position in the upper part of the first sub-area 100c, so that the formed α1 angle is within the upper semicircle (fig. 9), the first developing member 41 is omitted, and the first developing member 100b may be disposed at the position of the opposite side of the first sub-area 100c or the first sub-area 33 is located at the upper part of the left side of the first developing member 33, so that the developing member is located at the right side of the first sub-area 41, and the upper part 41 is indicated by the position 41.

Or the lumen stent 100 comprises a second developing member 42, the central angle alpha 2 of the axial line of the second developing member 42 corresponding to the axial line L2 of the binding position 33 is more than or equal to 45 degrees and less than or equal to 135 degrees, as shown in fig. 8, the second developing member 42 is in a non-axial symmetrical structure to distinguish the front and back directions of the lumen stent 100, so that the binding position 33 is arranged on a specific side (for example, the right side in fig. 8) of the second developing member 42, and the position of the binding position 33 in the circumferential direction can be indicated by the second developing member 42, so that the second region 100b penetrated by the limiting rod 73 can be prevented from being arranged on the small-bent side of the blood vessel under the condition that the lumen stent 100 is to be released in the half-release state, and thus the inner leakage of the distal end can be avoided. In addition, the problem of poor adhesion caused by displacement of the proximal end of the small bending side of the bracket due to the back-out limiting rod can be avoided, so that leakage at the proximal end is avoided.

The first developing member 41 is disposed at the proximal end of the stent body 10 or the stent 20, the developing assembly is disposed at the proximal end of the stent body 10 or the stent 20 to simultaneously indicate the position of the proximal end of the stent, the second developing member 42 is disposed at the proximal end or the distal end of the lumen stent 100, and the second developing member 42 can be disposed on the stent body 10 or the stent 20. The first developing member 41 may be disposed only to distinguish between the first side and the second side of the lumen stent 100, the second developing member 42 may be disposed only to distinguish between the front and the rear of the lumen stent 100, the second developing member 42 may be of a non-axially symmetrical structure when the second developing member 42 is disposed only to distinguish between the front and the rear of the lumen stent 100, the first developing member 41 and the second developing member 42 may be disposed simultaneously, and in other embodiments, the lumen stent 100 may further include a third developing member 43, the first developing member 41 is disposed in the second region 100b, the third developing member 43 is circumferentially symmetrical with the first developing member 41, and/or the second developing member 42 is rotated by 90 ° from the first developing member 41 in the circumferential direction, wherein the second developing member 42 may be disposed at the proximal or distal end of the coating film 20 by sewing.

When the shapes of the first developing member 41 and the third developing member 43 are different, the left and right sides of the lumen stent 100 can be distinguished, the second developing member 42 can be in an axially symmetrical structure or in a non-axially symmetrical structure, the first developing member 41 and the third developing member 43 are in the same shape, the second developing member 42 needs to be in a non-axially symmetrical structure to distinguish the front and back sides of the lumen stent 100, and the second area 100b can be attached to the side of the great curve of the blood vessel to release the constraint of the half release structure 30 of the lumen stent 100 when the lumen stent 100 is implanted in the blood vessel, so that the lumen stent 100 is completely released. In one embodiment, the non-axially symmetric structure of the second developer 42 may be a recognizable pattern of non-axially symmetric shape including a closed structure of "6" type, "G" type, "9" type, etc.

As shown in fig. 4 to 5 in combination with fig. 10 to 13, in the present embodiment, the lumen stent 100 includes a first developing member 41, a second developing member 42 and a third developing member 43, the first developing member 41 and the third developing member 43 are disposed at the proximal end of the coating film 20, the second developing member 42 is disposed at the distal end of the coating film 20, and each developing member can be fixed to the coating film 20 by sewing. The first developing member 41 and the second developing member 42 are different shapes, the first developing member 41 is disposed in the second area 100b, and the first developing member 41 may be disposed in an "8" shape, and the plurality of limiting members 330 may form a binding position 33 along the axial direction, and sequentially disposed on the middle axial line of the second area 100b, so as to form an axial line L2 where the binding position 33 is located, in this embodiment, the first developing member is also disposed on the middle axial line of the second area 100b, so the middle axial line of the second area 100b is an 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 binding position 33 is located are on the same axial line, that is, α=0° in this embodiment, as shown in fig. 10. The first developing member 41 and the limiting member 330 are arranged on the same axial line (or the axial line of the first developing member 41 relative to the limiting member 330 deflects by no more than 10 degrees), the first developing member 41 is sewed on the near-center end of the covering film 20, the limiting member 330 is arranged as a sewing thread buckle, the middle position of the wave rod 111c surrounding the corresponding wave ring 111 is sewed on the covering film 20 or the covering film 20 beside the middle position of the wave rod 111c is directly sewed without surrounding the wave rod 111c, and a gap is reserved for the binding unit 31 to pass through. The third developing member 43 may be configured as a "0" type, and is symmetrical to the first developing member 41 along the circumferential center, the different structures of the first developing member 41 and the second developing member 42 may distinguish the left-right direction (the first side and the second side) of the lumen stent 100, the second developing member 42 may be configured as a "0" type, and the second developing member 42 is disposed at the distal end of the coating film 20 of the lumen stent 100, and the second developing member 42 is rotated by 90 ° from the first developing member 41 along the circumferential direction, and under the developing angle shown in fig. 4, the second developing member 42 is disposed on the middle vertical line connecting the first developing member 41 and the third developing member 43, so that a three-dimensional structure may be formed between the second developing member 41 and the third developing member 43, so as to determine whether the distal end of the stent is uniformly spread in the circumferential direction after the lumen stent 100 is completely released. In other embodiments, only the first developing device 41 may be provided, or only the second developing device 42 having a non-axially symmetrical structure may be provided, and only the developing device may indicate the circumferential position of the binding site 33, so that the lumen stent 100 in the half-bound state may be adjusted in the circumferential direction to attach the binding site 33 to the great vessel curvature side, which is not limited herein.

The two ends of the binding unit 31 are generally releasably bound to the binding positions 33, so that the half-release structure 30 performs half-binding on the circumferential direction of the stent body 10. When the limiting rod 73 is disposed in the conveying device 70 to define the binding unit 31, the limiting rod 73 is generally disposed at the binding position 33 in the second area 100b along the axial direction, so that two ends of the wire harness 311 are defined in the second area 100b to compress the radial direction of the lumen stent 100, in this embodiment, the latch assemblies 312 at two ends of the wire harness 311 are close to each other in the middle position of the second area 100b, and the limiting rod 73 passes through the latch assemblies 312 at two ends to compress the wavy rings 111 of the lumen stent 100, and the limiting rod 73 sequentially passes through the latch assemblies 312 at two ends of the wire harness 311 corresponding to each wavy ring, so as to compress the radius of the lumen stent 100 as a whole to a half-bound state. The lumen stent 100 further comprises a first side and a second side in the circumferential direction, wherein the first side and the second side respectively occupy 180 degrees in the circumferential direction, the second region 100b is located in a range of a region M of an angle average line of the first side, the first side of the lumen stent is located on a large curved side of an aortic arch part when being implanted in a blood vessel, the second side is located on a small curved side of the aortic arch part when being implanted in the blood vessel, the setting of the developing assembly can be used for indicating the position of the constraint position 33 in the circumferential direction so as to be convenient for distinguishing the first side and the second side of the lumen stent 100 in the implantation process of the lumen stent 100, the constraint position 33 of the second region 100b can be corresponding to the large curved side of the blood vessel when being adjusted in a half release state, so that the second region 100b is attached to the large curved side of the blood vessel when being implanted in the blood vessel, thereby preventing the stop lever 73 from being retracted in the half release state, the proximal end of the second side of the stent is caused to be retracted, thereby preventing the proximal end of the stent from being retracted towards the distal end of the stent from being fully released towards the distal end of the stent 20, and preventing the distal end of the lumen stent from being fully released from being fully expanding towards the distal end of the stent 100, and preventing the distal end from being fully released towards the distal end of the stent from being fully expanding towards the distal end of the stent 100, and preventing the distal end from being fully released towards the distal end.

It will be appreciated that if the lumen stent 100 is in the semi-release state, the circumcircle diameter of the cross section is too large, the lumen stent 100 is easy to be attached to the inner wall of a blood vessel in the semi-release state, which is not beneficial to axial and circumferential adjustment, and if the circumcircle diameter of the cross section is too small when the lumen stent 100 is in the semi-release state, even if the circumferential or axial position is adjusted, after the semi-release state is released, due to the large radial change of the stent, larger circumferential and axial positioning deviation may still exist, so that the function of the semi-release structure 30 is not good. 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 naturally expanding is 0.5 to 0.8.

Since the circumcircle circumference of the cross section in the semi-release state is the circumferential length of the wire harness 311, the ratio of the circumcircle diameter of the cross section when the lumen stent 100 is in the semi-release state to the circumcircle diameter of the cross section when the lumen stent 100 is naturally expanded is equal to the ratio of the central angle corresponding to the first region 100a in the circumferential direction to the 360-degree angle of the circumference, when the ratio of the circumcircle diameter of the cross section in the semi-release state of the lumen stent to the circumcircle diameter of the cross section when the lumen stent is naturally expanded is 0.5, the central angle corresponding to the first region in the circumferential direction is 180 degrees, and when the ratio of the circumcircle diameter of the cross section in the semi-release state of the lumen stent to the circumcircle diameter of the cross section when the lumen stent is naturally expanded is 0.8, the central angle corresponding to the first region in the circumferential direction is 288 degrees, and the central angle corresponding to the second region in the circumferential direction is 72 degrees. Defining the central angle spanned by the second region 100b as beta, as shown in fig. 7, the central angle corresponding to the first region 100a in the circumferential direction is equal to 360 deg. -beta, wherein beta satisfies 72 deg. beta.180 deg. or less, when the beta satisfies 90 deg. < beta.180 deg., the first developing member 41 is arranged in the range of + -45 deg. region M of the angle average line of the second region 100b or the first sub-region 100c, and when the alpha satisfies 72 deg. < beta.90 deg., the first developing member 41 is arranged in the second region 100b or the first sub-region 100c to distinguish the first side and the second side of the lumen stent 100, and the stop bar 73 in the second region 100b is closer to the middle position of the first side, so that the stop bar 73 in the binding position is further attached to the large curved side of the blood vessel by means of the indication of the developing assembly 40 when the lumen stent 100 is in the half-release state.

The constraining position 33 of the lumen stent includes at least one limiting member 330, where the limiting member 330 may be used to limit the limiting rod 73 at the constraining position, in this embodiment, the constraining position 33 of the lumen stent 100 includes a plurality of limiting members, the limiting members are axially disposed in the second region 100b, the limiting members are generally disposed in a range of ±45° regions M of an angular average line of the second region 100b, and distances between the limiting members 312 at two ends of the wire harness 311 in a circumferential direction are equal or approximately equal, so that in a half-release state of the lumen stent 100, the limiting rod 73 in the second region 100b is closer to a middle position of a great vessel bend side, and when the lumen stent 100 is radially compressed to a half-constraining state, one end of the constraining unit 31 may pass through the limiting members, and then sequentially pass the limiting rod 73 through the limiting members 312 at two ends of the constraining unit 31. The number of the limiting members can be specifically determined according to the number of the bracket wavy rings 111 and the extent to which the bracket wavy rings are axially and semi-limited and want to extend, the limiting members are axially spaced to form the limiting position 33, the central angle between the axial line of the limiting member and the axial line L1 of the first developing member 41 is alpha, the limiting members are circumferentially closer to the middle position of the second region 100b than the first developing member 41, when the lumen stent 100 is radially compressed and contracted to the semi-release state, the locking component 312 at one end of the beam line 311 passes through the limiting member at the corresponding position in the circumferential direction, and then the limiting rod 73 passes through the locking component 312, so that the limiting member limits the limiting rod 73 at the circumferential position, and the limiting rod 73 is limited at the limiting member position, as shown in fig. 13. When α=0°, the limiting member and the first developing member 41 are on the same axial line L1, as shown in fig. 10-11 in combination with fig. 12-13, and the limiting members are axially disposed within 10 ° of each of the left and right sides of the middle axial line L1 of the second region 100b, in one embodiment, the limiting members and the first developing member 41 are both located on the middle axial line of the second region 100b, so that the distances between the limiting members and the latch assemblies 312 at two ends of the beam diameter line 311 in the circumferential direction are approximately equal, so that when the lumen stent 100 is in the half-release state, the compression state of the lumen stent 100 is uniform, and the half-constraint state is more stable.

The plurality of limiting members may be sequentially arranged on each wavy annular object 111 or the coating film 20 corresponding to the middle position of the wavy rod 111c along the same axial line, or may deflect slightly, so long as the semi-binding is not affected, the limiting members are not limited herein, the limiting members include a first limiting member and a second limiting member, only the central angle between the axial line of any limiting member (binding position 33) and the axial line L1 of the first developing member 41 is required to meet the alpha, and the deflection of the first limiting member in the circumferential direction relative to the second limiting member is less than or equal to 10 degrees, so that the limiting rod 73 is substantially required along the axial direction.

The present invention also provides a stent system comprising a delivery device 70 and a lumen stent 100 as described above, the delivery device 70 comprising a sheath-core assembly 71, a sheath 72 and a stop bar 73, the stop bar 73 extending axially along the second region 100b and being movably connected to a catch assembly 312, the lumen stent 100 being radially compressed in a loading zone formed between the sheath 72 and the sheath-core assembly 71.

Taking implantation of the main thoracic support system as an example, as shown in fig. 14-17, when the support system is delivered to a predetermined position, the sheath 72 is withdrawn, the lumen support 100 is incompletely released to a half-release state due to the effect of the half-constraint structure, so as to prevent the air pocket effect, as shown in fig. 15, the axial position of the lumen support 100 can be finely adjusted, so that the release position of the lumen support 100 is more accurate, meanwhile, according to the position of the first developing member 41, the circumferential position of the lumen support 100 is adjusted, so that the side of the limiting rod 73 of the support system is attached to the large curved side of the blood vessel, as shown in fig. 15-16, the proximal end of the small curved side of the support is prevented from being shifted towards the telecentric end due to the release of the half-constraint limiting rod 73, so as to prevent the proximal end of the small curved side of the lumen support 100 from being attached to the defective, and on the other hand, the telecentric end of the small curved side of the lumen support 100 is prevented from being in a state of being recessed towards the large curved side until the release of the support is completed, so that the telecentric end of the small curved side of the lumen support is prevented from being completely unfurled. After the stop lever 73 is retracted, the half-bound state is released, and the lumen stent 100 is completely released, and as shown in fig. 17, in this embodiment, when the lumen stent 100 is completely released, the perpendicular bisectors L3 (i.e., the center line of the blood vessel) of the first developing device 41 and the third developing device 43 are defined, and whether the distal end of the lumen stent 100 is uniformly spread or not can be determined according to the position of the second developing device 42 with respect to the perpendicular bisectors L3 of the first developing device 41 and the third developing device 43.

In other embodiments, the limiting rod 73 may also pass through the limiting member, so that the limiting member limits the limiting rod 73 on an axial line (i.e. a binding position) where the limiting member is located, the limiting rod 73 also passes through the first lock 3121 and the second lock 3122, and simultaneously, the first lock 3121 and the second lock 3122 are limited on the axial line where the limiting member is located, and the retraction of the semi-binding structure may also be achieved, which is not limited herein, and the setting position of the limiting member, that is, the binding position 33, can be achieved only by at least one of the lock component 312 or the limiting rod 73 passing through the limiting member.

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

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

Claims

1. A lumen stent is characterized by comprising a stent main body, a semi-release structure and a developing assembly, wherein the semi-release structure comprises a constraint unit and a constraint position, the lumen stent comprises a first area and a second area along the circumferential direction, the area which can be spanned by the constraint unit in the circumferential direction of the lumen stent is defined as a first area when the lumen stent is in a natural expansion state, the area which can not be spanned by the constraint unit in the circumferential direction is defined as a second area, the constraint position is arranged in the second area, the constraint position comprises at least one limiting piece, the developing assembly is used for indicating the position of the constraint position in the circumferential direction, a first subarea which is symmetrical to the center of the second area is arranged in the first area, the developing assembly comprises a first developing piece,

2. The lumen stent of claim 1, wherein a ratio of a central angle corresponding to the first region in the circumferential direction to a central angle corresponding to the second region in the circumferential direction is 1:1-4:1, and a central angle corresponding to the second region in the circumferential direction is defined as β, and β satisfies 72 ° or more and 180 ° or less, wherein the binding position is located within a region of ±45° of an angular average line of the second region when the β satisfies 90 ° < β and 180 °, and wherein the binding position is located within the second region when the β satisfies 72 ° < β and 90 °.

3. The lumen stent of claim 1, wherein the constraining unit is passable through the limiter when the lumen stent is radially compressed to a semi-constrained state;

4. The luminal stent of claim 3, wherein the number of stop members is a plurality, wherein the plurality of stop members comprises a first stop member and a second stop member, and wherein the first stop member has a circumferential deflection of less than or equal to 10 ° relative to the second stop member.

5. A stent system comprising a delivery device and a lumen stent as claimed in any one of claims 1 to 4, wherein the delivery device comprises a sheath-core assembly and a stop bar, the constraining unit comprising a wire harness and a catch assembly, the stop bar being extendable along the constraining position in an axial direction of the lumen stent so as to movably pass through the catch assembly to compress the lumen stent into a circumference defined by the wire harness to constrain the lumen stent in a semi-constrained state.

6. The stent system of claim 5, wherein the semi-release structure further comprises a stop collar disposed circumferentially about the stent body, the binding unit passing circumferentially through the stop collar such that the stop collar defines an axial position of the binding unit.

7. The lumen stent is characterized by comprising a stent main body, a semi-release structure and a developing assembly, wherein the semi-release structure comprises a constraint unit and a constraint position, the lumen stent comprises a first area and a second area along the circumferential direction, the area which can be spanned by the constraint unit in the circumferential direction of the lumen stent is defined as the first area in a state of natural expansion of the lumen stent, the area which cannot be spanned by the constraint unit in the circumferential direction is defined as the second area, the constraint position is arranged in the second area, the constraint position comprises at least one limiting piece, the developing assembly is used for indicating the position of the constraint position in the circumferential direction, the lumen stent further comprises a covering film covered on the stent main body, the developing assembly comprises a first developing piece, the first developing piece is arranged in the second area, the center angle of an axial line where the first developing piece is positioned and the axial line where the constraint position is positioned is smaller than or equal to 45 degrees, the lumen stent comprises a second developing piece, and the second developing piece is arranged on the circumferential direction of the first developing piece, the first developing piece and the second developing piece is arranged on the stent along the axial line or the axial direction of the stent or near the axial end of the stent or the main body.

8. The lumen stent of claim 7, wherein the constraining unit is passable through the limiter when the lumen stent is radially compressed to a semi-constrained state;

9. The luminal stent of claim 8, wherein the number of stop members is a plurality, wherein the plurality of stop members comprises a first stop member and a second stop member, and wherein the first stop member has a circumferential deflection of less than or equal to 10 ° relative to the second stop member.

10. The lumen stent of claim 7, further comprising a first sub-region within the first region that is centrally symmetric with the second region, the lumen stent further comprising a third visualization member, a circumferential location of the third visualization member being centrally symmetric with a location of the first visualization member in a circumferential direction.

11. The lumen stent of claim 10, wherein the first developing member is shaped differently than the third developing member, and the second developing member is of axially symmetric or non-axially symmetric construction;

12. A stent system comprising a delivery device and a lumen stent as claimed in any one of claims 7 to 11, wherein the delivery device comprises a sheath-core assembly and a stop bar, the constraining unit comprising a wire harness and a catch assembly, the stop bar being extendable along the constraining position in an axial direction of the lumen stent so as to movably pass through the catch assembly to compress the lumen stent into a circumference defined by the wire harness to constrain the lumen stent in a semi-constrained state.

13. The stent system of claim 12, wherein the semi-release structure further comprises a stop collar disposed circumferentially about the stent body, the binding unit passing circumferentially through the stop collar such that the stop collar defines an axial position of the binding unit.