Lumen stent and stent system

Abstract

The invention relates to a lumen stent and a stent system. The lumen stent comprises a main body stent, a first groove part, a first inner branch, a first through hole and a second through hole, the main body support comprises a first side and a second side in the circumferential direction, the first groove part is arranged on the first side and is sunken towards the inner side of the main body support, and the first inner branch is arranged on one side of the near end of the first groove part; the first through hole is formed in one side of the near end of the first groove part and communicated with the first groove part, and the second through hole is formed in the far end of the first groove part and communicated 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 body bracket close to the first side. When the lumen stent is conveyed conveniently, the sheath core can penetrate through the lumen stent, the first groove part can be positioned on the large bent side of the arch part through the sheath core, and the first groove part corresponds to an upper arch branch opening of the large bent side under driving of the sheath core.

Description

Technical Field

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

[0002] Thoracic endovascular aortic repair (TEVAR) is a method for treating aortic diseases. A covered stent is used to seal the rupture opening of the vascular dissection or the aneurysm, promote thrombosis, prevent the rupture of the dissection or aneurysm, achieve aortic remodeling, and improve blood supply to the blood vessels.

[0003] Currently, clinical studies have shown that there are multiple classifications of the morphology of the human aortic arch. The existing aortic arch stents are difficult to achieve good therapeutic effects for different arch shapes. For aortic arch types with different torsional morphologies, classification is based on the size of the included angle α formed at the intersection point by the extension lines of the proximal and distal ends of the aortic arch. Using 10° and 30° as the dividing lines, the aortic arch is divided into three types, F1 type, F2 type, and F3 type, where Figures 1-6 the front side and the rear side refer to the front side and the rear side of the human body of the aortic arch. The F1 type means that the aortic arch is straight or the included angle ≤ 10°, and the aortic arch is approximately a straight line in the top-down view, as shown in Figure 1 ; the F2 type means that the included angle of the aortic arch is 10° < α ≤ 30°, as shown in Figure 2 ; the F3 type means that the included angle of the aortic arch is α > 30°, as shown in Figure 3 .

[0004] In order to provide a better construction space for the branches (901 brachiocephalic trunk artery, 902 left common carotid artery, 903 left subclavian artery) of the aortic arch, in the prior art, a groove stent 001 can be used to construct a groove space on the large curvature side of the aortic arch. However, for the F3 type of aortic arch with a relatively large torsional degree, part of the groove space 002 of the groove stent may deflect forward at the moment of release due to the torsional morphology of the aortic arch, as shown in Figures 4-5 . However, the branch openings of the aortic arch are at the top of the aortic arch. This part of the aortic arch twists forward, resulting in the groove space 002 constructed using the groove part being unable to correspondingly cover the openings of the branch vessels (901, 902, 903) at the arch top, as shown in Figures 5-6 . As a result, it is difficult to select branch guide wires, and it is difficult to reconstruct the branches. Even the covering film on the non-groove part blocks the branch openings, as shown in Figures 4-6 . Summary of the Invention

[0005] One technical problem solved by the present invention is how to provide a lumen stent, the groove portion of which can be better aligned with the branch opening above the aortic arch without being affected by the torsional degree of the aortic arch type, so as to avoid difficulties in aligning the branch opening, difficult reconstruction of the branch, and even the problem that the film covering the non-groove portion blocks the branch opening.

[0006] The present invention provides a lumen stent, which includes a main stent, a first groove portion, a first inner branch, a first through hole, and a second through hole; the main stent includes a first side and a second side in the circumferential direction, the first groove portion is provided on the first side and recesses toward the inner side of the main stent, and the first inner branch is provided on the proximal side of the first groove portion; the first through hole is provided on the proximal side of the first groove portion and communicates with the first groove portion, the second through hole is provided at the distal end of the first groove portion and communicates with the first groove portion, and the first through hole, the first groove portion, and the second through hole form an axial channel in the main stent near the first side.

[0007] In one embodiment, the first groove portion has a groove structure with a distal opening, and the first groove portion includes a first proximal film provided on its proximal side; the lumen stent further includes a second inner branch, and the first proximal film includes a first branch opening and a second branch opening corresponding to the inner branch, and the first inner branch and the second inner branch are respectively provided at the first branch opening and the second branch opening; the first through hole is provided between the first inner branch and the second inner branch and is close to the first side of the main stent.

[0008] In one embodiment, the first groove portion further includes a bottom and a distal opening, and the bottom extends distally from the bottom edge of the first proximal film; the lumen stent 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, and the free end and the distal opening are spaced apart in the radial direction to form the second through hole;

[0009] Or, the distal end of the first support mesh cover includes an extension portion, and the extension portion bends and extends toward the central axis direction of the lumen stent to be connected to the distal opening, and the grid gap of the extension portion forms the second through hole.

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

[0011] In one embodiment, the lumen stent further includes an extension stent, and the proximal end of the extension stent penetrates through the main stent from the distal end of the main stent.

[0012] In one embodiment, the extension stent includes a second groove portion and a third inner branch. The second groove portion includes a second proximal membrane provided on its proximal side. The second proximal membrane is provided with a third branch opening, and the third inner branch extends proximally from the third branch opening.

[0013] In one embodiment, the first groove portion further includes a bottom and a distal opening. The bottom extends distally from the bottom edge of the first proximal membrane. The bottom includes a groove support member and a groove membrane covering the groove support member. The main stent includes main wave rings arranged at intervals along the axis, and the groove support member is integrally formed with the main wave ring adjacent to it in the circumferential direction.

[0014] In one embodiment, the first through hole is provided in the first proximal membrane in a "cross" - shaped opening.

[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 includes a handle assembly, a sheath core assembly, and a tip head. The tip head is connected to the end of the sheath core assembly away from the handle assembly, and the tip head can pass through the proximal end of the main stent along the axial channel.

[0016] In one embodiment, the stent system further includes a blocking balloon for blocking the first through hole, and the blocking balloon has a dense mesh structure.

[0017] One technical effect of an embodiment of the present invention is that the present invention provides a lumen stent. By providing an axial channel passing through the first groove portion, when being delivered, it is convenient for the sheath core of the delivery device to pass through, so that the sheath core adheres to the large curvature side of the aortic arch along with the delivery guide wire. The sheath core can be cooperated with the axial channel to drive the stent to conform to the bending shape of the aortic arch, which is convenient for positioning the first groove portion on the large curvature side of the aortic arch. The first groove portion located on the first side of the main stent directly corresponds to the supra - aortic branch opening on the large curvature side under the drive of the sheath core, preventing the opening of the first groove portion from being covered by non - branch openings due to the natural expansion and torsion of the stent, which is not conducive to the selection of the branch guide wire into the inner branch opening. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a top - view schematic diagram of an F1 - type aortic arch;

[0019] Figure 2 It is a top - view schematic diagram of an F2 - type aortic arch;

[0020] Figure 3 It is a top - view schematic diagram of an F3 - type aortic arch;

[0021] Figure 4Schematic diagram of the circumferential torsion of the groove part relative to the greater curvature side of the aortic arch during the implantation and release of the groove stent system in the prior art;

[0022] Figure 5 It is Figure 4 Schematic diagram seen from the ascending aorta side looking towards the descending aorta side in

[0023] Figure 6 It is Figure 4 Top view schematic diagram of

[0024] Figure 7 Structural schematic diagram of the lumen stent provided by the present invention;

[0025] Figure 8 It is Figure 7 Structural schematic diagram without covering the first support mesh cover;

[0026] Figure 9 It is Figure 7 Structural schematic diagram of the first support mesh cover in

[0027] Figure 9a It is Figure 9 Top view of the first support mesh cover in

[0028] Figure 10 It is Figure 7 Simplified structural diagram of

[0029] Figure 11 It is Figure 7 Structural schematic diagram of the interior from the proximal end towards the distal end perspective;

[0030] Figure 12 Structural schematic diagram of the lumen stent of other embodiments provided by the present invention;

[0031] Figure 13 Structural schematic diagram of the lumen stent of other embodiments provided by the present invention;

[0032] Figure 14 Structural schematic diagram of the stent system after the lumen stent provided by the present invention is implanted and released in the aortic arch;

[0033] Figure 15 It is Figure 14 Top view of

[0034] Figure 16 It is Figure 14 Schematic diagram seen from the ascending aorta looking towards the descending aorta direction;

[0035] Figure 17 Structural schematic diagram of the extension stent provided by the present invention;

[0036] Figure 18 It is Figure 17Schematic structural diagram of the second support net cover omitted;

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

[0038] Figure 20 Schematic structural diagram of the extension bracket of other embodiments provided by the present invention;

[0039] Figure 21 Schematic structural diagram of the lumen stent of other embodiments provided by the present invention;

[0040] Figure 22 Schematic structural diagram of the lumen stent of other embodiments provided by the present invention;

[0041] Figure 23 For Figure 22 Schematic structural diagram of the integrally formed (with film covering) of the groove support member and the main body wave loop (half wave loop) adjacent to it in the circumferential direction in ;

[0042] Figure 24 For Figure 23 Schematic structural diagram of the groove support member and the half wave loop in ;

[0043] Figure 25 Schematic structural diagram of the integrally formed (with film covering) of the groove support member (double wave interleaved) and the half wave loop of another embodiment provided by the present invention;

[0044] Figure 26 For Figure 25 Schematic structural diagram of the groove support member and the half wave loop in ;

[0045] Figure 27 Schematic structural diagram of the integrally formed (with film covering) of the groove support member and the half wave loop of other embodiments provided by the present invention. Specific embodiments

[0046] For ease of understanding of the present invention, the present invention will be described more comprehensively below with reference to the relevant drawings. The preferred embodiments of the present invention are shown in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of the present invention more thorough and comprehensive.

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

[0048] It should be understood that the terms used herein are for the purpose of describing specific example implementations only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" as used herein may also include the plural forms. The terms "comprising", "including", "containing" and "having" are inclusive and thus specify the presence of the stated features, steps, operations, elements and / or components, but do not preclude 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 to be construed as necessarily requiring them to be performed in the particular order described or illustrated, unless the order of performance is explicitly stated. It should also be understood that additional or alternative steps may be used.

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

[0050] For ease of description, spatial relative relationship terms may be used in the text to describe the relationship of one element or feature shown in the figure relative to another element or feature. These relative relationship terms are, for example, "inner", "outer", "inner side", "outer side", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device during use or operation other than the orientations depicted in the figure. For example, if the device in the figure is flipped, an element described as "below" or "beneath" other elements or features will then be oriented as "above" or "over" other elements or features. Thus, the exemplary 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 relationship descriptors used in the text are accordingly interpreted.

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

[0052] When the lumen stent is implanted at the aortic arch position, the lumen stent is generally curved as a whole. Usually, the side of the lumen stent facing the branch vessels of the aortic arch is defined as the first side of the lumen stent; the side of the lumen stent facing away from the branch vessels of the aortic arch is defined as the second side of the covered stent.

[0053] The present invention provides a lumen stent 100, as Figures 7-27 shown. The lumen stent 100 is generally a tubular hollow structure with openings at both ends, and includes a main stent 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. Among them, the main stent 10 includes main wave rings 13 arranged at intervals along the axis and a main film covering 14 covering the main wave rings 13.

[0054] As Figures 4-6 shown, in the prior art, since the groove stent is provided with a groove portion, when the main stent is loaded and compressed in the sheath tube, since the groove portion and the sheath core assembly 71 both correspond to the large curvature side of the aortic arch, the groove portion and the sheath core assembly 71 are on the same side. However, due to the presence of the first groove portion 11, the circular shape inside the main stent 10 is damaged, and the sheath core assembly 71 and the groove bottom 0021 are more likely to relatively slide at the moment when the stent naturally expands, as Figure 5 shown.

[0055] In this embodiment, as Figures 7-8As shown, the main body stent 10 includes a first side and a second side in the circumferential direction. Among them, the first side and the second side each account for 180° in the circumferential direction. The first groove portion 11 is provided on the first side of the lumen stent 100 and recessed toward the inner side of the main body stent 10. When the lumen stent 100 is implanted into a blood vessel, the first side of the lumen stent 100 corresponds to the large curvature side of the aortic arch portion, so that the first groove portion 11 corresponds to the supra-arch branch opening on the large curvature side. The first inner branch 101 extends from the first groove portion 11 toward the proximal end of the main body stent 10, that is, the first inner branch 101 is provided on the proximal side of the first groove portion 11. The first through hole 111 is provided on the proximal side of the first groove portion 11, and the first through hole 111 communicates the first groove portion 11 with the main cavity of the main body stent 10. The size range of the first through hole 111 in the circumferential direction is: 6 mm to 8 mm, so as to facilitate the passage of the sheath core and the tip head 72, and at the same time prevent the opening from being too large; the second through hole 112 is provided at the distal end of the first groove portion 11, and the second through hole 112 communicates the first groove portion 11 with the main cavity of the main body stent 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 stent 10 near the first side. The axial channel 1101 is provided at the position close to the first side of the main body stent 10 to facilitate the sheath core in the delivery device to pass through. On the one hand, since the sheath core is attached to the large curvature side of the arch portion along with the delivery guide wire, the sheath core can be cooperated with the axial channel 1101 to drive the stent to conform to the bending shape of the arch portion, so as to facilitate positioning the first groove portion 11 on the large curvature side of the arch portion. The first groove portion 11 located on the first side of the main body stent 10 directly corresponds to the supra-arch branch opening on the large curvature side under the drive of the sheath core, preventing the slot opening of the first groove portion 11 from being covered by non-branch openings due to the natural expansion and torsion of the stent, which is not conducive to the selection of the branch guide wire into the inner branch opening; on the other hand, since the hole shape structure of the inner branch needs to maintain its hole shape before the reconstruction of the branch stent, annular support members 101a need to be provided at both axial ends of the inner branch to maintain the hole shape. Taking the apex of the aortic arch as the boundary, the part extending from the apex toward the ascending aorta direction is defined as the upper arch portion, and the part extending from the apex (such as Figure 4 the horizontal dotted line in the figure) toward the descending aorta direction is defined as the lower arch portion. Since the proximal end of the first groove portion 11 is close to the ascending aorta direction, the sheath core located here is in the folded part (upper arch portion) of the arch shape. Since this part is in the upper arch portion of the folded part, the connection between the sheath core and the tip head 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 stent to be pulled and displaced toward the descending aorta direction, thus affecting the withdrawal of the sheath core. Therefore, the passage formed by the first inner branch 101, the second inner branch 102 extending toward the proximal end and the first groove portion 11 cannot be used as the axial channel 1101 for the sheath core to pass through.

[0056] Such as Figures 7-9 Combined with Figure 11As shown, the first groove portion 11 further includes a bottom 113 and an open distal end 114, and the bottom 113 extends from the bottom edge of the first proximal cover 110 toward the distal end to form the open distal end 114 of the first groove portion 11. The endoluminal stent 100 further includes a first support mesh cover 12 covering the first groove portion 11, and the distal end of the first support mesh cover 12 includes a free end 121, and the free end 121 is radially spaced from the open distal end 114 to form a second through hole 112. Figure 9 Combination Figure 9a As shown, in the design of the first supporting mesh cover 12, the braided wires of the middle mesh cover part (123) of the first supporting mesh cover 12 are generally staggered and overlapped to maintain the radial supporting force of the first supporting mesh cover 12, thereby ensuring the groove space; the mesh cover parts on both sides of the axial direction of the first supporting mesh cover 12 are set as hook structures 122, so that the first supporting mesh cover 12 has an anti-shortening effect in the axial direction. When the free end 121 and the open distal end 114 are radially spaced apart, the width of the second through hole 112 is the same as the radial dimension of the first groove, so that when the sheath core passes through the axial channel 1101, the sheath core mainly positions the proximal end of the first groove portion 11 through the first through hole 111, thereby positioning the proximal end of the first groove portion 11 on the large curve 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. For the case where the bow is more twisted, the inner branch of the proximal end of the first groove portion 11 can correspond to the branch opening of the bow portion in the axial direction, while ensuring that the other parts of the first groove portion 11 naturally conform to the bow portion and do not twist excessively in the circumferential direction, so that the main support 10 is more stable after being released; it can also prevent the braided wire on the first support mesh cover 12 from excessively twisting in the circumferential direction, causing the hook structure 122 of the braided wire to be misplaced and stimulate the blood vessels.

[0057] In the present embodiment, the first groove portion 11 is a groove structure with a distal opening, and the first groove portion 11 includes a first proximal coating 110 disposed on its proximal side, and the first proximal coating 110 includes a first branch opening 110a and a second branch opening 110b corresponding to the inner branch, and the first branch opening 110a and the second branch opening 110b are arranged at intervals on the first proximal coating 110, and the first inner branch 101 and the second inner branch 102 are arranged at the first branch opening 110a and the second branch opening 110b respectively; the first through hole 111 is arranged between the first inner branch 101 and the second inner branch 102, and is close to the first side of the main support 10. Among them, the first through hole 111 is a "cross"-shaped opening, and is arranged on the first proximal coating 110 and close to the middle line of the first side (in the present embodiment, the middle line of the first side refers to Figure 11(the axial line where the highest point of the shown circle is located), the cross-shaped opening enables sufficient 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 coated at the cross-shaped opening to facilitate coagulation after the sheath core is withdrawn, without the need to block the first through hole 111; in other embodiments, a sealing balloon with a dense mesh structure can also be implanted to block the first through hole 111.

[0058] In other embodiments, such as Figure 12 shown, the distal end of the first support mesh cover 12 may not be provided with a free end but an extension 124. The extension 124 bends and extends towards the central axis direction of the lumen stent 100, so as to connect with the distal opening 114. The grid gap formed by the extension 124 forms the second through hole 112.

[0059] In other embodiments, such as Figure 13 shown, the interval distance between the first inner branch 101 and the second inner branch 102 gradually increases in the direction from the distal end to the proximal end, making the withdrawal of the sheath core smoother and preventing the sheath core from hooking onto the annular support of the first inner branch 101 or the second inner branch 102 when the sheath core is withdrawn.

[0060] The present invention also provides a stent system, such as Figures 14-16 shown, which includes the lumen stent 100 as described above, and 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 in the figure) located outside the body, a sheath core assembly 71, and a tip 72. The tip 72 is connected to the end of the sheath core assembly 71 away from the handle assembly, and the tip 72 can pass through the proximal end of the main stent 10 along the axial channel 1101. In other stent systems, the sheath core assembly 71 can also pass through the main lumen of the main stent 10 from the proximal end of the main stent 10.

[0061] The stent system provided by this embodiment further includes a second delivery device (not shown in the figure) for delivering the extension stent 20. The main stent 10 can be released at the ascending aorta and part of the aortic arch using the first delivery device 70, and then the extension stent 20 can be implanted using the second delivery device. The proximal end of the extension stent 20 passes through the distal end of the main stent 10 and is disposed within the main stent 10, such that the main stent 10 and the extension stent 20 are anchored together to cover 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 sheath core assembly of the first delivery device 70 to pass through. Since during the process of delivering the main stent 10, the sheath core assembly adheres to the convex side of the aortic arch along with the delivery guide wire, the sheath core can cooperate with this axial channel 1101 to drive the stent to conform to the curved shape of the aortic arch, and at the same time position the first groove portion 11 at the convex side of the aortic arch. The first groove portion 11 located at the first side of the main stent 10 directly corresponds to the supra-aortic branch opening at the convex side under the drive of the sheath core, as Figures 14-16 shown, preventing the slot of the first groove portion 11 from being covered by a non-branch opening due to the natural expansion and torsion of the stent.

[0062] The stent system may further include a blocking balloon for blocking the first through hole 111, and the first through hole 111 corresponds to a circumscribed circle. As Figure 11 shown, a suture line is sutured in a circle along the circumference of the circumscribed circle, and the extending direction of the suture line is along the circumference, thereby forming a protection boundary for the first through hole 111 to prevent the first through hole 111 from being reamed when the blocking balloon blocks the first through hole 111. The blocking balloon has a dense mesh structure. After the main stent 10 is completely released, the blocking balloon can be delivered to the first through hole 111 through the supra-aortic branch to block the first through hole 111, and then the supra-aortic branch stent can be implanted.

[0063] The lumen stent 100 further includes an extension stent 20. As Figures 17-20 shown, the proximal end of the extension stent 20 passes through the distal end of the main stent 10 and is disposed within the main stent 10 to be anchored and cooperate with the main stent 10, such that the main lumen of the extension stent 20 is communicated with that of the main stent 10 to form a stent body by splicing. The overlapping part of the proximal end of the extension stent that penetrates into the main stent is the anchoring part, and the axial length range of the anchoring part can be set to: 30 mm to 70 mm. In this embodiment, the extension stent 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 membrane disposed at its distal side. The second support mesh cover 23 covers the second groove portion 21 and forms a groove space between the second support mesh cover 23 and the second groove portion 21. In this embodiment, the third inner branch 22 is disposed on its distal membrane and extends towards the distal end, as Figures 17-19As shown. In other embodiments, the extension stent 20 may also include a second proximal membrane 211 disposed on the proximal side of the second groove portion 21, and a third branch opening is formed on the second proximal membrane 211. The third inner branch 22 extends toward the proximal end from the third branch opening, as Figure 20 shown. In other embodiments, the proximal outer shape of the extension stent 20 may also be provided with a shape that matches the concave main cavity shape of the distal end of the main body stent 10 due to the arrangement of the first groove portion, so as to facilitate the anchoring of the two together.

[0064] When three branches are provided, the third inner branch 22 is arranged on the extension stent 20 such that the extension direction of the third inner branch 22 is not restricted, so that the three inner branches of the aortic stent can all extend toward the proximal end, while not overly occupying the cross-sectional area of the blood flow in the same radial direction, nor increasing the radial cross-sectional ratio, and not affecting the assembly of the stent and the sheath; compared with the existing groove stent with three inner branches, if the three branches are all extended toward the proximal opening, it will occupy too much main cavity space and affect the blood flow velocity in the main cavity (when the heart pumps out the same amount of blood, when the blood flow cross-sectional area becomes smaller, it will cause an increase in blood pressure and increase the burden on the heart; at the same time, it will cause an increase in the penetration amount of the membrane, which is likely to lead to a poor isolation effect of the aneurysm; it will also cause the blood flow velocity to be too fast, which is also likely to cause thrombosis). In addition, it will also increase the radial cross-sectional ratio and affect the assembly of the stent and the sheath.

[0065] In other embodiments, the extension stent 20 may not be provided with the second groove portion 21 and the inner branch. The first inner branch 101 and the second inner branch 102 are provided on the first groove portion 11 of the main body stent 10. The main body stent 10 and the extension stent 20 together form an aortic arch stent system having two inner branches extending toward the proximal end.

[0066] In other embodiments, as Figure 21 shown, if the lumen stent 100 does not include the extension stent, the main body stent 10 itself extends toward the distal end and includes the first inner branch 101 and the second inner branch 102 extending toward the proximal end, and the 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 straddles three supra-aortic branches, its third inner branch is located at the lower arch portion, where the bending of the sheath core is relatively small compared to the upper arch portion and is not in the folded portion of the upper arch portion. When the sheath core is retracted, it will not hook the annular support of the third inner branch 103. Therefore, the third inner branch in this embodiment can be used as a part of the axial channel 1101.

[0067] In this embodiment, the bottom 113 of the first groove portion 11 includes a groove support member 1131 and a groove coating film 1132 covering the groove support member 1131. The main body bracket 10 includes main body corrugated rings 13 arranged at intervals along the axial direction. The groove support member 1131 and the main body corrugated ring 13 adjacent to it in the circumferential direction are integrally formed, as Figures 22-23 shown. The main body corrugated ring 13 includes a non-circular half corrugated ring 131 and a complete circular corrugated ring 132. Among them, the half corrugated ring 131 is arranged on the main body bracket 10 corresponding to the first groove portion 11, and the complete circular corrugated ring 132 is arranged on the main body bracket 10 not corresponding to the first groove portion 11. The half corrugated ring 131 is adjacent to the groove support member 1131 in the circumferential direction. The half corrugated ring 131 and the groove support member 1131 can be two separate waveform structures to form a D-shaped tube, or can be a D-shaped tube formed by an integrally formed waveform structure, as Figures 22-27 shown.

[0068] Since the groove coating film 1132 is a film that is secondarily cut with respect to the main body coating film 14, the secondarily cut groove coating film 1132 needs to be sutured to the main body coating film 14 of the main body bracket 10. The half corrugated ring 131 can be arranged on the outer side of the main body coating film 14, and the groove support member 1131 is sutured to the inner side of the groove coating film 1132, so that the surface of the groove coating film 1132 close to the first side is a smooth surface, which can prevent the branch guide wire from being hooked on the groove support member 1131 when the branch guide wire passes through the first groove portion 11 to select the inner branch; in the existing groove bracket, since the distal end of the groove has a certain length of the main body bracket portion, it is extremely difficult to integrally form the groove support member 1131 and the main body corrugated ring 13 adjacent to it in the circumferential direction and then suture the corrugated ring portion of the groove support member 1131 to the inner side of the groove coating film 1132. Therefore, the existing groove support member 1131 and the half corrugated ring 131 are both split structures. In the prior art, generally, after the groove support member 1131 is sutured to the groove coating film 1132, the groove coating film 1132 with the groove support member 1131 is sutured to the main body coating film 14. In this embodiment, the distal end of the first groove portion is set as an open distal end, which is convenient for integrally forming the groove support member 1131 on the first groove portion and the main body corrugated ring 13 adjacent to it in the circumferential direction without increasing the suturing difficulty, improving the overall performance of the stent without increasing the labor cost; in addition, as Figure 10As shown, the axial length L1 of the main body stent 10 satisfies: 70 mm ≤ L1 ≤ 90 mm; the axial length L11 of the first groove portion 11 satisfies: 30 mm ≤ L11 ≤ 40 mm; the axial length L12 of the first inner branch 101 or the second inner branch 102 satisfies: 20 mm ≤ L12 ≤ 30 mm; the distal end portion of its first support mesh cover 12 is connected to or radially spaced from the distal opening 114. The first groove portion 11 extends the overall anchoring length of the main body stent 10, so that the anchoring length of the main body stent 10 is not limited by the length of the ascending aorta, increasing the anchoring reliability of the main body stent 10, and the main body stent 10 does not span the entire aortic arch. For the case where the aortic arch is relatively tortuous, it can also reduce the possibility that the braided wires on the first support mesh cover 12 are misaligned at the hooked portions due to excessive circumferential torsion during circumferential transition, thus irritating the blood vessel.

[0069] Since the size of the lumen stent 100 is generally 10% - 20% larger than the size of the blood vessel into which it is implanted, the lumen stent 100 is generally squeezed by the blood vessel after being implanted into the blood vessel. The half-wave loops 131 and the groove support member 1131 form a D-shaped wave. The integral molding of the D-shaped wave can provide sufficient supporting force at the D-shaped inflection point, as Figures 22-27 shown, enabling the waveform support member of the groove support member 1131 to extend along its waveform extension direction (as Figure 23Compressed in the opposite direction of the arrow shown in the figure, the spatial shape of the groove in its groove height can be maintained, preventing the groove support 1131 from sagging towards the lumen center, resulting in a smaller cross-sectional area of the main lumen, or bulging away from the lumen center to block the inner branch opening, causing ischemia of the branch vessels. In other embodiments, the waveform structure formed at the connection between the groove support 1131 and the half-wave loop 131 is the first connection wave 1320. The middle waveform unit of the groove support 1131 excluding both ends is the second connection wave 1131a. The first connection wave 1320 includes a first wave rod 1321, a second wave rod 11311, and a first connection 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 connection wave 1131a includes a third wave rod 11312, a fourth wave rod 11313, and a second connection 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 1131. The wave angle of the first connection wave 1320 is greater than the wave angle of the second connection wave 1131a, that is, the included angle formed by the first connection arc 1322 is greater than the included angle formed by the second connection arc 11315, or the rod width of the first connection arc 1322 is greater than the rod width of the second connection arc 11315. To ensure that when the main stent 10 is radially compressed, it can be ensured that the first connection wave 1320 has greater support than the second connection wave 1131a, that is, at the inflection point of the D-shaped wave, there is greater support force in the waveform extension direction of the groove support 1131, so that the second connection wave 1131a of the groove support 1131 itself is slightly compressed on the D-shaped plane, rather than the position of the groove support 1131 relative to the first connection wave 1320 sagging towards the lumen center or bulging away from the lumen center, so as to maintain the spatial shape of the first groove portion 11 in its groove height direction, preventing the groove support 1131 from sagging towards the lumen center, resulting in a smaller cross-sectional area of the main lumen of the main stent 10, or bulging away from the lumen center to block the inner branch opening, causing ischemia of the branch vessels. It can also make the extension stent 20 pass through the inner side of the distal end of the main stent 10 and anchor with the main stent 10, so that the bottom 113 of the first groove portion 11 can conform to the shape of the proximal end of the extension stent 20, making the two fit better (where the implantation of the extension stent 20 is completed after the construction of the branch stent on the arch, so it does not affect the selection of the guide wire for the branch stent).

[0070] In addition, the groove support 1131 and the half-wave wave ring 131 are set to be an integrated D-type wave (at this time, in the manufacturing process of the main support 10, the integrated D-type wave can only be sewn to the main body coating 14 first, and then the middle part of the groove coating 1132 is sewn to the groove support 1131, and the edge part of the groove coating 1132 is sewn to the groove edge of the main body coating 14). This can ensure that the difficulty of suturing the groove support 1131 and the groove coating 1132 is not increased too much, and at the same time, better support force can be provided to the first connecting wave 1320. However, when the axial edge of the groove coating 1132 is sewn to the axial edge of the main body coating 14, its first connecting arc 1322 needs to pass through the stitching, which may easily lead to loose stitching of the groove coating 1132 and the main body coating 14, thereby causing internal leakage at the position where the first connecting arc 1322 passes. Figure 27 As shown, the entire first wave bar 1321 can be brought close to the plane where the groove support 1131 is located, and the first wave bar 1321 includes a first section 1321a close to the first connecting arc 1322, and the first section 1321a is parallel to the bottom 113 of the first groove portion 11 or the angle β between the first section 1321a and the bottom 113 is less than 10°. The edges of the main body coating 14 and the groove coating 1132 at the corresponding part of the first section 1321a can be sutured separately and then sutured together, so as to facilitate the suture of the above-mentioned perforation with the help of the first section 1321a to prevent internal leakage caused by the lax suture of the perforation. In the 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-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0072] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A lumen stent, characterized in that, The lumen stent includes a main stent, a first groove portion, a first inner branch, a first through hole, and a second through hole; the main stent includes a first side and a second side in the circumferential direction, the first groove portion is provided on the first side and recessed toward the inner side of the main stent, and the first inner branch is provided on the proximal side of the first groove portion; the first through hole is provided on the proximal side of the first groove portion and communicates with the first groove portion, the second through hole is provided at the distal end of the first groove portion and communicates with the first groove portion, and the first through hole, the first groove portion, and the second through hole form an axial channel within the main stent near the first side.

2. The lumen stent according to claim 1, wherein, The first groove portion has a groove structure with a distal opening, and the first groove portion includes a first proximal film provided on its proximal side; the lumen stent further includes a second inner branch, the first proximal film includes a first branch opening and a second branch opening corresponding to the inner branch, and the first inner branch and the second inner branch are respectively provided at the first branch opening and the second branch opening; the first through hole is provided between the first inner branch and the second inner branch and is close to the first side of the main stent.

3. The luminal stent according to claim 2, characterized in that, The first groove portion further includes a bottom and a distal opening, and the bottom extends distally from the bottom edge of the first proximal film; the lumen stent 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, and the free end and the distal opening are spaced apart radially to form the second through hole. Or, the distal end of the first support mesh cover includes an extension portion that bends and extends toward the central axis direction of the lumen stent to connect with the distal opening, and the mesh gap of the extension portion forms the second through hole.

4. The luminal stent according to claim 2, wherein The spacing distance between the first inner branch and the second inner branch gradually increases in the direction from the distal end to the proximal end.

5. The luminal stent according to claim 2, characterized in that, The lumen stent further includes an extension stent, and the proximal end of the extension stent penetrates through the main stent from the distal end of the main stent.

6. The luminal stent according to claim 5, wherein The extension stent includes a second groove portion and a third inner branch, the second groove portion includes a second proximal film provided on its proximal side, and the second proximal film is provided with a third branch opening, and the third inner branch extends proximally from the third branch opening.

7. The lumen stent according to claim 2, characterized in that, The first groove portion further includes a bottom and a distal opening, and the bottom extends distally from the bottom edge of the first proximal film; the bottom includes a groove support member and a groove film covering the groove support member; the main stent includes main wave rings arranged at axial intervals, and the groove support member is integrally formed with the adjacent main wave ring in the circumferential direction.

8. The lumen stent according to claim 2, wherein The first through hole is provided in a "cross" shape on the first proximal film.

9. A stent system, comprising the lumen stent according to any one of claims 1-7, characterized in that, The stent system includes a first delivery device, the first delivery device includes a handle assembly, a sheath core assembly, and a tip, the tip is connected to the end of the sheath core assembly away from the handle assembly, and the tip can pass through the proximal end of the main stent along the axial channel.

10. The stent system according to claim 9, wherein The stent system further includes a blocking balloon for blocking the first through hole, and the blocking balloon has a dense mesh structure.

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