Lumen stent and stent system

Abstract

The application relates to a kind of luminal stents and stent systems, the luminal stent includes main body stent, first recess portion, first inner branch, first through hole and second through hole;The main body stent includes first side and second side in the circumference, the first recess portion is arranged at the first side and is recessed towards the inside of the main body stent, the first inner branch is arranged at the proximal side of the first recess portion;The first through hole is arranged at the proximal side of the first recess portion and is communicated with the first recess portion, the second through hole is arranged at the distal end of the first recess portion and is communicated with the first recess portion, the first through hole, the first recess portion and the second through hole form an axial channel in the main body stent close to the first side.The luminal stent provided by the application is convenient to be transported, and the sheath core can pass through, the first recess portion can be positioned at the large bending side of the arch portion by the sheath core, so that the first recess portion is driven by the sheath core and corresponds to the arch upper branch port of the large bending side.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical devices, and particularly relates to a lumen stent and a stent system. BACKGROUND

[0002] Thoracic endovascular aortic repair (TEVAR) is a method for treating aortic diseases. A covered stent is used to close a blood vessel dissection break or an aneurysm, promote thrombosis, prevent dissection or aneurysm rupture, achieve aortic reconstruction, and improve blood supply.

[0003] Current clinical research shows that the shape of the human aortic arch has multiple types, and the existing aortic arch stents cannot achieve good efficacy in the face of different arch shapes. For different torsional shapes of the aortic arch, the aortic arch is classified according to the size of the angle α formed by the intersection of the extension lines of the proximal end and the distal end of the aortic arch. The aortic arch is divided into three types, F1, F2 and F3, with 10° and 30° as the dividing lines, where Figures 1-6 The front side and the back side refer to the front side and the back side of the human body of the aortic arch. F1 represents that the aortic arch is straight or the angle is ≤10°, and the aortic arch is approximately a straight line under the perspective of a top view, as shown in Figure 1 F2 represents that the aortic arch angle is 10°<α≤30°, as shown in Figure 2 F3 represents that the aortic arch angle is α>30°, as shown in Figure 3 .

[0004] In order to provide a better construction space for the branches (901 head-arm trunk artery, 902 left common carotid artery, 903 left subclavian artery) of the aortic arch, a groove stent 001 can be used to construct a groove space on the large bending side of the aortic arch in the prior art, but for the F3 type aortic arch with a large degree of torsion, the groove space 002 part of the groove stent may be deflected to the front side due to the torsional shape of the aortic arch at the moment of release, as shown in Figures 4-5 However, the aortic arch branch openings are at the top of the aortic arch, and the part of the aortic arch that is twisted forward will cause the groove space 002 constructed by the groove part to fail to correspond to the branch blood vessel (901, 902, 903) openings at the top of the arch, as shown in Figures 5-6 , thereby causing difficulty in selecting a branch guide wire and making it difficult to reconstruct the branch, or even causing the non-groove part of the covered membrane to block the branch opening, as shown in Figures 4-6 . SUMMARY

[0005] The present application solves one technical problem of how to provide a lumen stent, the groove part of which can be better aligned with the branch opening on the aortic arch, thereby avoiding the difficulty in aligning the branch opening, the difficulty in reconstructing the branch, and the problem of the non-groove part of the stent covering the branch opening.

[0006] The present application provides a lumen stent, which comprises a main stent, a first groove part, a first inner branch, a first through hole and a second through hole; the main stent comprises a first side and a second side in the circumferential direction, the first groove part is arranged on the first side and is recessed towards the inner side of the main stent, and the first inner branch is arranged on the proximal side of the first groove part; the first through hole is arranged on the proximal side of the first groove part and communicates with the first groove part, and the second through hole is arranged on the distal end of the first groove part and communicates with the first groove part, and the first through hole, the first groove part and the second through hole form an axial channel in the main stent close to the first side.

[0007] In one embodiment, the first groove part is a distally open groove structure, the first groove part comprises a first proximal covering film arranged on the proximal side thereof, the first proximal covering film comprises a first branch opening and a second branch opening corresponding to the inner branches, and the first inner branch and the second inner branch are arranged at the first branch opening and the second branch opening respectively; the first through hole is arranged between the first inner branch and the second inner branch and close to the first side of the main stent.

[0008] In one embodiment, the first groove part further comprises a bottom and an open distal end, the bottom extends from the bottom edge of the first proximal covering film towards the distal end; the lumen stent further comprises a first support mesh cover covering the first groove part; the distal end of the first support mesh cover comprises a free end, and the free end is arranged radially spaced apart from the open distal end to form the second through hole.

[0009] Alternatively, the distal end of the first support mesh cover comprises an extension part, the extension part is curved and extends towards the central axis direction of the lumen stent, thereby being connected with the open distal end, and the mesh gap of the extension part forms the second through hole.

[0010] In one embodiment, the distance between the first inner branch and the second inner branch gradually increases from the distal end to the proximal end.

[0011] In one embodiment, the lumen stent further comprises an extension stent, the proximal end of the extension stent is arranged in the main stent from the distal end of the main stent.

[0012] In one embodiment, the extension support includes a second recess and a third inner branch. The second recess includes a second proximal cover disposed on its proximal side. The second proximal cover has a third branch opening, and the third inner branch extends from the third branch opening toward the proximal end.

[0013] In one embodiment, the first groove portion further includes a bottom and an opening distal end, the bottom extending from the bottom edge of the first proximal end cover toward the distal end; the bottom includes a groove support and a groove cover covering the groove support; the main support includes main waverings spaced apart along the axial direction, the groove support being integrally formed with the main waverings adjacent to it in the circumferential direction.

[0014] In one embodiment, the first through hole is provided in a cross shape at the first proximal end of the coating.

[0015] The present invention also provides a stent system including the lumen stent as described above. The stent system includes a first delivery device, the first delivery device including a handle assembly, a sheath assembly and a tip, the tip being connected to the end of the sheath assembly away from the handle assembly, and the tip being able to extend through the proximal end of the main stent along the axial channel.

[0016] In one embodiment, the stent system further includes an occlusion balloon for sealing the first through-hole, the occlusion balloon having a dense mesh structure.

[0017] One technical effect of an embodiment of the present invention is that the present invention provides a lumen support, which, by setting an axial channel through the first groove, facilitates the passage of the sheath core of the conveying device during transport, so that the sheath core, along with the conveying guide wire, is attached to the large bend side of the bow. With the help of the sheath core and the axial channel, the sheath core can drive the support to conform to the bending shape of the bow, making it easier to position the first groove on the large bend side of the bow. The first groove on the first side of the main support directly corresponds to the branch opening on the large bend side of the bow under the drive of the sheath core, preventing the slot of the first groove from being covered by the non-branch opening due to the natural expansion and torsion of the support, which would be detrimental to the selection of the branch guide wire into the inner branch opening. Attached Figure Description

[0018] Figure 1 This is a top view of the F1 type aortic arch;

[0019] Figure 2 This is a top view of the F2 type aortic arch;

[0020] Figure 3 This is a top view of the F3 type aortic arch;

[0021] Figure 4A schematic diagram showing the circumferential torsion of the groove relative to the greater curvature of the aortic arch during the release of a grooved stent system implanted in the aortic arch in the prior art.

[0022] Figure 5 for Figure 4 A schematic diagram showing the view from the ascending main direction to the descending main direction;

[0023] Figure 6 for Figure 4 A top-down view;

[0024] Figure 7 This is a schematic diagram of the structure of the lumen support provided by the present invention;

[0025] Figure 8 for Figure 7 Schematic diagram of the structure without the first supporting mesh cover;

[0026] Figure 9 for Figure 7 A schematic diagram of the structure of the first supporting mesh cover;

[0027] Figure 9a for Figure 9 A top view of the first supporting mesh cover in the middle;

[0028] Figure 10 for Figure 7 Simplified structural diagram;

[0029] Figure 11 for Figure 7 A schematic diagram of the internal structure viewed from the proximal end to the distal end;

[0030] Figure 12 This is a schematic diagram of the structure of a lumen support according to other embodiments of the present invention;

[0031] Figure 13 This is a schematic diagram of the structure of a lumen support according to other embodiments of the present invention;

[0032] Figure 14 This is a schematic diagram of the stent system provided by the present invention after the luminal stent is implanted into the aortic arch and released.

[0033] Figure 15 for Figure 14 Top view;

[0034] Figure 16 for Figure 14 A diagram showing the direction from the ascendant to the describable;

[0035] Figure 17 This is a schematic diagram of the structure of the extension bracket provided by the present invention;

[0036] Figure 18 for Figure 17The structural diagram of the second support mesh cover is omitted.

[0037] Figure 19 for Figure 17 Simplified structural diagram;

[0038] Figure 20 Schematic diagram of the structure of the extension bracket for other embodiments of the present invention;

[0039] Figure 21 This is a schematic diagram of the structure of a lumen support according to other embodiments of the present invention;

[0040] Figure 22 This is a schematic diagram of the structure of a lumen support according to other embodiments of the present invention;

[0041] Figure 23 for Figure 22 A schematic diagram of the structure of the grooved support and its adjacent circumferential main wave ring (half wave ring) integrally formed (with a coating);

[0042] Figure 24 for Figure 23 A schematic diagram of the grooved support and the half-wave ring in the middle;

[0043] Figure 25 A schematic diagram of the structure of a groove support (double wave interlaced) and a half wave ring integrally formed (with a film) according to another embodiment of the present invention;

[0044] Figure 26 for Figure 25 A schematic diagram of the grooved support and the half-wave ring in the middle;

[0045] Figure 27 This is a schematic diagram of the structure of a groove support and a half-wave ring integrally formed (with a film) for other embodiments of the present invention. Detailed Implementation

[0046] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the invention.

[0047] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0048] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0049] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0050] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0051] For ease of description, the following description uses the terms "distal" and "proximal," where "distal" refers to the end furthest from the heart and "proximal" refers to the end closest to the heart. The phrase "axial direction" should be understood in this patent as indicating the direction in which the interventional device is advanced and de-escalated. The direction perpendicular to the "axial direction" is defined as the "radial direction."

[0052] When a luminal stent is implanted at the aortic arch, the stent is generally curved. The side of the stent facing the branch vessels of the aortic arch is usually defined as the first side of the stent, and the side of the stent away from the branch vessels of the aortic arch is defined as the second side of the covered stent.

[0053] This invention provides a lumen stent 100, such as Figures 7-27 As shown, the lumen support 100 has an overall tubular hollow structure with openings at both ends, including a main support 10, a first groove portion 11, a first inner branch 101, a second inner branch 102, a first through hole 111, and a second through hole 112. The main support 10 includes a main corrugated coil 13 arranged axially at intervals and a main coating 14 covering the main corrugated coil 13.

[0054] like Figures 4-6 As shown, in the prior art, because the grooved bracket has a groove, when the main bracket is loaded and compressed inside the sheath, since both the groove and the sheath core assembly 71 should be on the side of the large bend of the bow, the groove and the sheath core assembly 71 are located on the same side. However, because the presence of the first groove 11 disrupts the circular shape inside the cavity of the main bracket 10, the sheath core assembly 71 and the groove bottom 0021 are more likely to slide relative to each other during the instant the bracket naturally expands. Figure 5 As shown.

[0055] In this embodiment, such as Figures 7-8As shown, the main stent 10 includes a first side and a second side in the circumferential direction, wherein the first side and the second side each occupy 180° in the circumferential direction. The first groove portion 11 is provided on the first side of the lumen stent 100 and is recessed towards the inner side of the main stent 10. When the lumen stent 100 is implanted into the blood vessel, the first side of the lumen stent 100 corresponds to the greater curvature side of the aortic arch, such that the first groove portion 11 corresponds to the supra-arc branch opening on the greater curvature side. The first inner branch 101 extends from the first groove portion 11 toward the proximal end of the main body support 10, that is, the first inner branch 101 is located on one side of the proximal end of the first groove portion 11, and the first through hole 111 is located on one side of the proximal end of the first groove portion 11, and the first through hole 111 connects the first groove portion 11 with the main cavity of the main body support 10. The circumferential dimension of the first through hole 111 is 6mm~8mm, so as to facilitate the passage of the sheath core and the tip 72, while not making the opening too large; the second through hole 112 is located at the distal end of the first groove portion 11, and the second through hole 112 connects the first groove portion 11 with the main cavity of the main body support 10. The first through hole 111, the first groove portion 11, and the second through hole 112 form an axial channel 1101 in the main body support 10 near the first side. An axial channel 1101 is provided at a position attached to the first side of the main stent 10 to facilitate the passage of the sheath core in the delivery device. On the one hand, since the sheath core is attached to the large bend side of the arch with the delivery guide wire, the sheath core can cooperate with the axial channel 1101 to make the sheath core drive the stent to conform to the curvature of the arch, which facilitates the positioning of the first groove 11 on the large bend side of the arch. The first groove 11 located on the first side of the main stent 10 directly corresponds to the upper branch opening of the arch on the large bend side under the drive of the sheath core, preventing the slot of the first groove 11 from being covered by the non-branch opening due to the natural expansion and torsion of the stent, which would be detrimental to the selection of the branch guide wire into the inner branch opening; on the other hand, since the hole structure of the inner branch needs to maintain its hole shape before the branch stent is reconstructed, annular support members 101a need to be provided at both ends of the axial direction of the inner branch to maintain the hole shape. Taking the arch apex of the aortic arch as the boundary, the part extending from the arch apex toward the ascending aorta is defined as the upper arch, and the part extending from the arch apex (such as the upper arch) is defined as the part extending from the arch apex toward the ascending aorta. Figure 4 The portion extending towards the descending direction (middle horizontal dashed line) is the lower bow portion. Since the proximal end of the first groove portion 11 is close to the ascending direction, the sheath core located here is in the bow-shaped folded portion (upper bow portion). Because this part is located in the upper bow portion of the folded portion, the connection between the sheath core and the tip 72 is easily hooked by the annular support members at both ends of the first inner branch 101 and the second inner branch 102, which may cause the released support to shift in the descending direction, thereby affecting the retraction of the sheath core. Therefore, the passage formed by the first inner branch 101, the second inner branch 102 extending towards the proximal end and the first groove portion 11 cannot be used as the axial channel 1101 through which the sheath core passes.

[0056] like Figures 7-9 Combination Figure 11As shown, the first recessed portion 11 also includes a bottom 113 and an opening distal end 114. The bottom 113 extends from the bottom edge of the first proximal end covering 110 toward the distal end to form the opening distal end 114 of the first recessed portion 11. The lumen support 100 also includes a first support mesh cover 12 covering the first recessed portion 11. The distal end of the first support mesh cover 12 includes a free end 121, which is radially spaced from the opening distal end 114 to form a second through hole 112. Figure 9 Combination Figure 9a As shown, in the design of the first support mesh cover 12, the braided wires of the middle mesh cover part (123) of the first support mesh cover 12 are generally interlaced and overlapped to maintain the radial support force of the first support mesh cover 12, thereby ensuring the groove space; the mesh cover parts on both sides of the first support mesh cover 12 are set as hook structures 122, so that the first support mesh cover 12 has the function of preventing shortening in the axial direction at the same time. When the free end 121 and the distal end 114 of the opening are radially spaced, the width of the second through hole 112 is the same as the radial dimension of the first groove. This allows the sheath core to primarily position the proximal end of the first groove portion 11 through the first through hole 111 when passing through the axial channel 1101. This positions the proximal end of the first groove portion 11 on the large bend side, while the distal end of the first groove portion 11 is relatively free, not restricted by the sheath core, and does not need to twist with the sheath core. In cases where the bow shape is more twisted, the inner branch of the proximal end of the first groove portion 11 can correspond to the branch of the bow in the axial direction. At the same time, it ensures that the other parts of the first groove portion 11 naturally conform to the bow and do not twist excessively in the circumferential direction, making the main support 10 more stable after release. It can also prevent the braided wires on the first support mesh cover 12 from twisting excessively in the circumferential direction, causing the hook structure 122 of the braided wires to misalign and irritate blood vessels.

[0057] In this embodiment, the first groove portion 11 has a groove structure with a distal opening. The first groove portion 11 includes a first proximal end covering 110 disposed on its proximal side. The first proximal end covering 110 includes a first branch opening 110a and a second branch opening 110b corresponding to the inner branch. The first branch opening 110a and the second branch opening 110b are spaced apart on the first proximal end covering 110. A first inner branch 101 and a second inner branch 102 are respectively disposed on the first branch opening 110a and the second branch opening 110b. A first through hole 111 is disposed between the first inner branch 101 and the second inner branch 102, and is close to the first side of the main support 10. The first through hole 111 has a cross-shaped opening and is disposed on the first proximal end covering 110 and close to the center line of the first side (in this embodiment, the center line of the first side refers to...). Figure 11The axial line where the highest point of the circle is located (the cross-shaped opening provides enough space for the sheath core to be withdrawn, while ensuring that the opening of the first through hole 111 is not too large. Coagulation material can also be applied to the cross-shaped opening to facilitate coagulation after the sheath core is removed, without the need to seal the first through hole 111. In other embodiments, a occlusion balloon with a dense mesh structure can also be implanted to seal the first through hole 111.

[0058] In other implementations, such as Figure 12 As shown, the distal end of the first support mesh cover 12 may not have a free end but has an extension 124. The extension 124 bends and extends toward the central axis of the tube support 100, thereby connecting with the distal end 114 of the opening. The mesh gap formed by the extension 124 forms the second through hole 112.

[0059] In other implementations, such as Figure 13 As shown, the distance between the first inner branch 101 and the second inner branch 102 gradually increases from the far end to the near end, making the sheath core retraction smoother and preventing the sheath core from getting caught on the annular support of the first inner branch 101 or the second inner branch 102 when retracting.

[0060] The present invention also provides a support system, such as Figures 14-16 As shown, the stent 100, as described above, also includes a first delivery device 70. The first delivery device 70 is used to deliver the main stent 10 and includes a handle assembly (not shown), a sheath assembly 71, and a tip 72 located outside the body. The tip 72 is connected to the end of the sheath assembly 71 away from the handle assembly and can extend through the axial channel 1101 from the proximal end of the main stent 10. In other stent systems, the sheath assembly 71 can also extend through the main lumen of the main stent 10 from the proximal end of the main stent 10.

[0061] The stent system provided in this embodiment also includes a second delivery device (not shown) for delivering an extension stent 20. The first delivery device 70 can be used to release the main stent 10 at the ascending aorta and part of the aortic arch, and then the second delivery device can be used to implant the extension stent 20. The proximal end of the extension stent 20 passes through the main stent 10 from the distal end, anchoring the main stent 10 and the extension stent 20 together, covering the entire aortic arch. The distal end of the extension stent 20 can extend to the descending aorta. An axial channel 1101 is provided at a position adjacent to the first side of the main stent 10 to facilitate the passage of the sheath core assembly of the first delivery device 70. During the delivery of the main stent 10, the sheath core assembly, along with the delivery guidewire, adheres to the large bend side of the aortic arch. The sheath core, in conjunction with the axial channel 1101, allows the sheath core to guide the stent to conform to the curvature of the aorta. Simultaneously, the first groove 11 is positioned on the large bend side of the aorta. The first groove 11 on the first side of the main stent 10, driven by the sheath core, directly corresponds to the branch opening on the large bend side of the aorta. Figures 14-16 As shown, this is to prevent the slot of the first groove 11 from being covered by the non-branched opening due to the natural expansion and torsion of the bracket.

[0062] The stent system may also include an occlusion balloon for sealing the first through-hole 111, and the first through-hole 111 corresponds to a circumscribed circle, such as Figure 11 As shown, a suture is stitched around the circumference of the circumference of the circumference circle, with the suture extending circumferentially to form a protective boundary for the first through-hole 111. This prevents the first through-hole 111 from being enlarged when the occlusion balloon is used to block it. The occlusion balloon has a dense mesh structure and can be delivered to the first through-hole 111 via the supra-arc branch after the main stent 10 has been fully deployed to block the first through-hole 111. The supra-arc branch stent is then implanted afterward.

[0063] The lumen stent 100 also includes an extension stent 20, such as Figures 17-20 As shown, the proximal end of the extension bracket 20 passes through the distal end of the main bracket 10 and is anchored to it, so that the extension bracket 20 and the main cavity of the main bracket 10 are connected and spliced ​​into a bracket body. The part of the proximal end of the extension bracket that overlaps with the main bracket is the anchoring part, and the axial length of the anchoring part can be set to a range of 30mm to 70mm. In this embodiment, the extension bracket 20 includes a second groove portion 21, a third inner branch 22, and a second support mesh cover 23. The second groove portion 21 includes a distal end covering film disposed on its distal end side, and the second support mesh cover 23 covers the second groove portion 21 and forms a groove space between it and the second groove portion 21. In this embodiment, the third inner branch 22 is disposed on its distal end covering film and extends toward the distal end, such as Figures 17-19As shown. In other embodiments, the extension bracket 20 may also include a second proximal cover 211 disposed on the proximal side of the second groove portion 21, and the second proximal cover 211 has a third branch opening, with a third inner branch 22 extending from the third branch opening toward the proximal end, as shown. Figure 20 As shown. In other embodiments, the proximal shape of the extension bracket 20 may also be provided with a shape that matches the shape of the main cavity of the distal end of the main bracket 10, which is concave due to the provision of the first groove, so that the two can be anchored together.

[0064] When three branches are configured, the third inner branch 22 is placed in the extended stent 20 so that the extension direction of the third inner branch 22 is unrestricted. This allows all three inner branches of the aortic stent to extend proximally without excessively occupying the cross-sectional area of ​​blood flow in the same radial direction, nor increasing the radial cross-sectional area ratio, and without affecting the assembly of the stent and sheath. Compared to the existing grooved stent with three inner branches, if all three branches extend proximally, it will occupy too much main lumen space, affecting the main lumen blood flow velocity (when the heart pumps the same amount of blood, a smaller blood flow cross-sectional area will lead to increased blood pressure and increased cardiac workload; it will also lead to increased membrane permeability, which may result in poor aneurysm isolation; and it may also lead to excessively fast blood flow, which may cause thrombosis). In addition, it will also increase the radial cross-sectional area ratio, which will affect the assembly of the stent and sheath.

[0065] In other embodiments, the extension stent 20 may not have the second groove portion 21 and the inner branch. The first groove portion 11 of the main stent 10 is provided with the first inner branch 101 and the second inner branch 102. The main stent 10 and the extension stent 20 together constitute an aortic arch stent system with two inner branches extending towards the proximal end.

[0066] In other implementations, such as Figure 21 As shown, if the lumen support 100 does not include the extension support, the main support 10 itself extends toward the distal end and includes a first inner branch 101 and a second inner branch 102 extending toward the proximal end, and a third inner branch 103 disposed on the distal side of the first groove portion 11 and extending toward the distal end. Since the first groove portion 11 spans three upper bow branches, its third inner branch is located at the lower bow portion. Here, the bending of the sheath core is smaller than that of the upper bow portion and is not in the folded portion of the upper bow portion. When the sheath core is retracted, it will not hook the annular support of the third inner branch 103. Therefore, in this embodiment, the third inner branch can be used as part of the axial channel 1101.

[0067] In this embodiment, the bottom 113 of the first groove portion 11 includes a groove support 1131 and a groove covering film 1132 covering the groove support 1131. The main support 10 includes main corrugated rings 13 spaced apart along the axial direction. The groove support 1131 and its circumferentially adjacent main corrugated rings 13 are integrally formed, such as... Figures 22-23 As shown. The main wave coil 13 includes a non-circular half-wave coil 131 and a complete circular wave coil 132. The half-wave coil 131 is disposed on the main support 10 corresponding to the first groove portion 11, and the complete circular wave coil 132 is disposed on the main support 10 not corresponding to the first groove portion 11. The half-wave coil 131 is adjacent to the groove support member 1131 in the circumferential direction. The half-wave coil 131 and the groove support member 1131 can be two separate waveform structures to form a D-shaped tubular shape, or they can be a D-shaped tubular shape composed of an integrally formed waveform structure, such as... Figures 22-27 As shown.

[0068] Since the grooved membrane 1132 is a double-cut membrane relative to the main membrane 14, it needs to be sewn onto the main membrane 14 of the main support 10. The half-wave loop 131 can be placed on the outside of the main membrane 14, and the groove support 1131 can be sewn onto the inside of the grooved membrane 1132, making the side of the grooved membrane 1132 closest to the first side a smooth surface. This prevents the branch guide wire from getting caught on the groove support 1131 when selecting an inner branch through the first groove portion 11. The existing grooved support is composed of... The main support portion with a certain length at the distal end of the groove is extremely difficult to integrally form the groove support 1131 with the adjacent main corrugated coil 13 in the circumferential direction, and then sew the corrugated portion of the groove support 1131 to the inner side of the groove cover film 1132. Therefore, the existing groove support 1131 and the half corrugated coil 131 are both separate structures. In the prior art, the groove support 1131 is generally sewn to the groove cover film 1132, and then the groove cover film 1132 with the groove support 1131 is sewn to the main cover film 14. In this embodiment, the distal end of the first groove portion is set as an open distal end, which facilitates the subsequent integral forming of the groove support 1131 on the first groove portion with the adjacent main corrugated coil 13 in the circumferential direction without increasing the sewing difficulty, improving the overall performance of the support without increasing labor costs; in addition, if Figure 10As shown, the axial length L1 of the main stent 10 satisfies: 70mm≤L1≤90mm; the axial length L11 of the first groove portion 11 satisfies: 30mm≤L11≤40mm; the axial length L12 of the first inner branch 101 or the second inner branch 102 satisfies: 20mm≤L12≤30mm; the distal end of its first support mesh cover 12 is connected to or radially spaced from the distal end of the opening 114. The first groove portion 11 extends the overall anchoring length of the main stent 10, so that the anchoring length of the main stent 10 is not limited by the length of the ascending main blood vessel, which increases the anchoring reliability of the main stent 10. Moreover, the main stent 10 will not span the entire arch. In the case of a more tortuous arch shape, it can also reduce the possibility of the braided wires on the first support mesh cover 12 being misaligned and irritating the blood vessel due to excessive twisting of the braided wires in the circumferential direction.

[0069] Since the size of the stent 100 is generally 10% to 20% larger than the size of the blood vessel into which it is implanted, the stent 100 is generally compressed by the blood vessel after implantation. The half-wave coil 131 and the grooved support 1131 form a D-shaped wave. The integral molding of this D-shaped wave can provide sufficient support at the D-shaped inflection point. Figures 22-27 As shown, the wave-shaped support of the groove support 1131 extends along its wave-shaped extension direction (e.g., Figure 23Compression in the opposite direction (as indicated by the middle arrow) can maintain the spatial shape of the groove at its groove height, preventing the groove support 1131 from concave towards the center of the lumen, causing a decrease in the cross-sectional area of ​​the main lumen, or from bulging away from the center of the lumen, obstructing the inner branch opening and causing branch vessel ischemia. In other embodiments, the waveform structure formed at the connection between the groove support 1131 and the half-wave loop 131 is the first connecting wave 1320, and the middle waveform unit of the groove support 1131 excluding both ends is the second connecting wave 1131a. The first connecting wave 1320 includes a first wave rod 1321, a second wave rod 11311, and a first connecting arc 1322 connecting the first wave rod 1321 and the second wave rod 11311; the first wave rod 1321 is the wave rod at one end of the half-wave loop 131, and the second wave rod 11311 is the wave rod at one end of the groove support 1131; the second connecting arc 1322 connecting the first wave rod 1321 and the second wave rod 11311; the second connecting arc 1322 connecting the first wave rod 1321 and the second wave rod 11311 are connected by a first connecting arc 1322. Wave 1131a includes a third wave rod 11312, a fourth wave rod 11313, and a second connecting arc 11315 connecting the third wave rod 11312 and the fourth wave rod 11313. Both the third wave rod 11312 and the fourth wave rod 11313 are wave rods of the groove support member 1131. The wave angle of the first connecting wave 1320 is greater than the wave angle of the second connecting wave 1131a, that is, the included angle formed by the first connecting arc 1322 is greater than the included angle formed by the second connecting arc 11315, or the rod width of the first connecting arc 1322 is greater than the rod width of the second connecting arc 11315, to ensure... When the main support 10 is subjected to radial compression, the first connecting wave 1320 can be guaranteed to have greater support than the second connecting wave 1131a. That is, the inflection point of the D-shaped wave has a greater supporting force relative to the waveform extension direction of the groove support 1131. This causes the second connecting wave 1131a of the groove support 1131 itself to be slightly compressed on the D-shaped plane, rather than the groove support 1131 being concave towards the center of the cavity or convex away from the center of the cavity relative to the first connecting wave 1320. This maintains the space of the first groove portion 11 in its groove height direction. The shape prevents the groove support 1131 from being recessed towards the center of the lumen, which would reduce the cross-sectional area of ​​the main lumen of the main stent 10, or from protruding away from the center of the lumen and obstructing the inner branch opening, thus causing branch vessel ischemia. It also allows the extension stent 20 to be inserted into the distal inner side of the main stent 10 so that when it is anchored with the main stent 10, the bottom 113 of the first groove portion 11 can conform to the shape of the proximal end of the extension stent 20, so that the two can fit better (wherein the extension stent 20 is implanted after the supra-arc branch stent is constructed, so it does not affect the selection of the guidewire for the branch stent).

[0070] Additionally, by making the groove support 1131 and the half-wave ring 131 into a single D-shaped wave (in the manufacturing process of the main body bracket 10, the single D-shaped wave can only be sewn onto the main body film 14 first, and then the middle part of the groove film 1132 is sewn onto the groove support 1131, and the edge part of the groove film 1132 is sewn onto the groove edge of the main body film 14), it is possible to ensure that the sewing difficulty of the groove support 1131 and the groove film 1132 is not excessively increased, while providing better support for the first connecting wave 1320. However, when the axial edge of the groove film 1132 is sewn onto the axial edge of the main body film 14, the first connecting arc 1322 needs to pass through this sewing point, which can easily lead to a loose sewing between the groove film 1132 and the main body film 14, resulting in internal leakage at the point where the first connecting arc 1322 passes through. Figure 27 As shown, the entire first wave rod 1321 can be placed close to the plane where the groove support 1131 is located. The first wave rod 1321 includes a first segment 1321a near the first connecting arc 1322. The first segment 1321a is parallel to the bottom 113 of the first groove portion 11, or the angle β between the first segment 1321a and the bottom 113 is less than 10°. The edges of the main body film 14 and the groove film 1132 at the corresponding position of the first segment 1321a can be sewn separately and then sewn together, which facilitates the tight sewing of the perforation with the help of the first segment 1321a, preventing internal leakage caused by poor sewing at the perforation. In its corresponding embodiment, the first conveying device 70 can pass through the proximal end of the main body support 10 along the main cavity of the main body support 10.

[0071] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.

[0072] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A lumen stent, characterized in that, The lumen support includes a main support, a first groove, a first inner branch, a first through hole, and a second through hole. The main support includes a first side and a second side in the circumferential direction. The first groove is located on the first side and recessed towards the inner side of the main support. The first inner branch is located on the proximal side of the first groove. The first through hole is located on the proximal side of the first groove and communicates with the first groove. The second through hole is located at the distal end of the first groove and communicates with the first groove. The first through hole, the first groove, and the second through hole form an axial channel in the main support near the first side. The axial channel is used for the sheath core to pass through, so as to drive the lumen support to conform to the curved shape of the bow. The first groove has a groove structure with a distal opening. The first groove includes a first proximal membrane located on its proximal side. The lumen support also includes a second inner branch. The first proximal membrane includes a first branch opening and a second branch opening corresponding to the inner branch. The first inner branch and the second inner branch are respectively located at the first branch opening and the second branch opening. The first through hole is located between the first inner branch and the second inner branch and is close to the first side of the main support.

2. The lumen stent according to claim 1, characterized in that, The first groove portion further includes a bottom and an opening distal end, the bottom extending from the bottom edge of the first proximal end covering towards the distal end; the lumen support further includes a first support mesh cover covering the first groove portion; the distal end of the first support mesh cover includes a free end, the free end and the opening distal end being radially spaced apart to form the second through hole; Alternatively, the distal end of the first support mesh cover includes an extension that bends and extends toward the central axis of the lumen support, thereby connecting with the distal end of the opening, and the mesh gaps of the extension form the second through hole.

3. The lumen stent according to claim 1, characterized in that, The distance between the first inner branch and the second inner branch gradually increases from the far end to the near end.

4. The lumen stent according to claim 1, characterized in that, The lumen stent also includes an extension stent, the proximal end of which extends through the distal end of the main stent into the main stent.

5. The lumen stent according to claim 4, characterized in that, The extension support includes a second groove and a third inner branch. The second groove includes a second proximal cover located on its proximal side. The second proximal cover has a third branch opening. The third inner branch extends from the third branch opening toward the proximal end.

6. The lumen stent according to claim 1, characterized in that, The first groove portion further includes a bottom and an opening distal end, the bottom extending from the bottom edge of the first proximal end covering towards the distal end; the bottom includes a groove support and a groove covering covering the groove support; the main support includes main waverings spaced apart along the axial direction, the groove support and the main waverings adjacent to it in the circumferential direction are integrally formed.

7. The lumen stent according to claim 1, characterized in that, The first through hole is a cross-shaped opening located on the first proximal end of the coating.

8. A stent system comprising a lumen stent as described in any one of claims 1-6, characterized in that, The support system includes a first delivery device, which includes a handle assembly, a sheath assembly, and a tip. The tip is connected to the end of the sheath assembly away from the handle assembly and can extend through the proximal end of the main support along the axial channel.

9. The support system according to claim 8, characterized in that, The stent system also includes a sealing balloon for sealing the first through hole, the sealing balloon having a dense mesh structure.

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