Lumen stent and stent system

Abstract

This invention relates to a lumen stent and stent system. The lumen stent includes a main stent, a first inner branch, and a first groove. The main stent 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 stent. The first inner branch extends from the first groove towards the proximal end of the main stent. The first groove includes a first proximal end cover, a bottom, and a distal opening. The first proximal end cover is located on the proximal side of the first groove, and the bottom extends from the bottom edge of the first proximal end cover towards the distal end to form the distal opening. The lumen stent also includes a first support mesh cover covering the first groove. The distal end of the first support mesh cover is connected to or radially spaced from the distal opening. The lumen stent of this invention increases anchoring reliability; facilitates the subsequent integral molding of the support member on the first groove with its circumferentially adjacent main body corrugated ring without increasing the difficulty of stitching, improving the overall performance of the stent without increasing labor costs.

Description

TECHNICAL FIELD

[0001] The present 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. The covered stent is used to close the blood vessel dissection break or hemangioma, promote thrombosis, prevent dissection or hemangioma rupture, achieve aortic reconstruction, and improve blood supply.

[0003] Current clinical studies show 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 and distal ends 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 the 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 and 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 towards the front will cause the groove space 002 constructed by the groove part to fail to cover the branch blood vessels (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 difficulty in reconstructing a branch, and even a covered film on the non-groove part blocking the branch opening, as shown in Figures 4-6 .

[0005] On the other hand, the existing groove support is designed to have a complex connection relationship or connection sequence between the groove film and the main body film and between the support of the groove part and the support of the main body support (main body wave ring) during production. Therefore, the D-shaped wave formed by the existing groove support and the adjacent main body wave ring is difficult to design as an integrated D-shaped structure, which increases the production cost. Therefore, the flat part and the arc part of the D-shaped wave are designed as a split structure, which may cause no support force at the D-shaped inflection point, resulting in the support of the groove part being concave towards the center of the lumen, reducing the cross-sectional area of the main lumen, or being convex away from the center of the lumen, blocking the branch vessel and causing ischemia of the branch vessel. SUMMARY

[0006] One of the technical problems solved by the present application is to provide a lumen stent to solve the problem that the D-shaped wave of the existing groove part is difficult to design as an integrated structure.

[0007] The present application provides a lumen stent, which comprises a main body support, a first inner branch and a first groove part. The main body support comprises a first side and a second side in the circumferential direction, the first groove part is recessed towards the inner side of the main body support and is arranged on the first side, and the first inner branch extends from the first groove part towards the proximal end of the main body support. The first groove part comprises a first proximal end film, a bottom and an open distal end. The first proximal end film is arranged on the proximal end side of the first groove part, the bottom extends from the bottom edge of the first proximal end film towards the distal end to form the open distal end. The lumen stent further comprises a first support net cover covering the first groove part, and the distal end of the first support net cover is connected to the open distal end or is arranged radially spaced apart from the open distal end.

[0008] In one embodiment, the bottom comprises a groove support and a groove film covering the groove support, and the main body support comprises main body wave rings arranged axially spaced apart, and the groove support is integrally formed with the main body wave ring adjacent in the circumferential direction.

[0009] In one embodiment, the distal end of the first support net cover comprises a free end, and the free end is arranged radially spaced apart from the open distal end.

[0010] Alternatively, the distal end of the first support net cover comprises an extension, and the extension is curved and extends towards the central axis of the lumen stent, so as to be connected to the open distal end.

[0011] In one of the embodiments, the luminal stent further comprises a first through hole and a second through hole, the first through hole is arranged at the proximal end side of the first groove portion and communicates with the first groove portion, the second through hole is arranged at the distal end of the first groove portion and communicates with the first groove portion, the first through hole, the first groove portion and the second through hole form an axial channel in the luminal stent close to the first side.

[0012] In one of the embodiments, the luminal stent further comprises a second inner branch, the first inner branch and the second inner branch are arranged at the first proximal end covering film in a spaced manner; the first through hole is arranged between the first inner branch and the second inner branch.

[0013] In one of the embodiments, 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.

[0014] In one of the embodiments, the luminal stent further comprises an extension stent, the proximal end of the extension stent is arranged in the main body stent from the distal end of the main body stent.

[0015] In one of the embodiments, the extension stent comprises a second groove portion and a third inner branch, the second groove portion comprises a second proximal end covering film, the third inner branch extends towards the proximal end from the first proximal end covering film.

[0016] The present application also provides a stent system comprising the luminal stent as described above, the stent system comprises a first delivery device, the first delivery device comprises a handle assembly, a sheath core assembly and a tip head, the tip head is connected to one end of the sheath core assembly away from the handle assembly, the sheath core assembly is arranged out of the proximal end of the main body stent along the main cavity of the main body stent.

[0017] The present application also provides another stent system comprising a luminal stent, the stent system comprises a first delivery device, the first delivery device comprises a handle assembly, a sheath core assembly and a tip head, the tip head is connected to one end of the sheath core assembly away from the handle assembly, the tip head can be arranged out of the proximal end of the main body stent along the axial channel.

[0018] One technical effect of one embodiment of the present application is that the lumen stent provided by the present application, by setting the first groove part including the open distal end, connects or radially spaces the distal end part of the first support net cover with the open distal end, on the one hand, the first groove part can extend the anchoring length of the main body stent on the ascending aorta, so that the anchoring length of the main body stent is not limited by the length of the ascending aorta, and the anchoring reliability of the main body stent is increased; on the other hand, the distal end of the first groove part is set as an open distal end, which facilitates subsequent integration of the support member on the first groove part and the main body wave coil adjacent to it in the circumferential direction without increasing the difficulty of suturing, improving the overall performance of the stent without increasing the labor cost. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 is a top view schematic diagram of F1 type aortic arch;

[0020] Figure 2 is a top view schematic diagram of F2 type aortic arch;

[0021] Figure 3 is a top view schematic diagram of F3 type aortic arch;

[0022] Figure 4 is a schematic diagram of the circumferential torsion of the groove part relative to the large bending side of the arch part when the groove stent system in the prior art is implanted in the aortic arch;

[0023] Figure 5 is Figure 4 is a schematic diagram from the ascending aorta to the descending aorta side;

[0024] Figure 6 is Figure 4 is a top view schematic diagram of F3 type aortic arch;

[0025] Figure 7 is a structural schematic diagram of the lumen stent provided by the present application;

[0026] Figure 8 is Figure 7 is a structural schematic diagram of the first support net cover of

[0027] Figure 9 is Figure 7 is a structural schematic diagram of the first support net cover of

[0028] Figure 9a is Figure 9 is a top view of the first support net cover in

[0029] Figure 10 is Figure 7 is a structural simplified diagram of

[0030] Figure 11 is Figure 7 is a structural schematic diagram of the inside from the proximal end to the distal end view.

[0031] Figure 12 This is a schematic diagram of the structure of a lumen support according to other embodiments of the present invention;

[0032] Figure 13 This is a schematic diagram of the structure of a lumen support according to other embodiments of the present invention;

[0033] 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.

[0034] Figure 15 for Figure 14 Top view;

[0035] Figure 16 for Figure 14 A diagram showing the direction from the ascendant to the describable;

[0036] Figure 17 This is a schematic diagram of the structure of the extension bracket provided by the present invention;

[0037] Figure 18 for Figure 17 The structural diagram of the second support mesh cover is omitted.

[0038] Figure 19 for Figure 17 Simplified structural diagram;

[0039] Figure 20 Schematic diagram of the structure of the extension bracket for other embodiments of the present invention;

[0040] Figure 21 This is a schematic diagram of the structure of a lumen support according to other embodiments of the present invention;

[0041] Figure 22 This is a schematic diagram of the structure of a lumen support according to other embodiments of the present invention;

[0042] 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);

[0043] Figure 24 for Figure 23 A schematic diagram of the grooved support and the half-wave ring in the middle;

[0044] 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;

[0045] Figure 26 forFigure 25 Structure diagram of the groove support and half-wave solenoid in the embodiment of the present application;

[0046] Figure 27 Structure diagram of the groove support and half-wave solenoid in the embodiment of the present application; DETAILED DESCRIPTION

[0047] For the purpose of promoting an understanding of the principles of the application, reference will now be made to the embodiments illustrated in the drawings. There is shown in the drawings, several embodiments of the application. It is readily appreciated that the drawings are not to scale and that actual dimensions can differ substantially from the dimensions shown in the drawings. The application disclosed herein can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and fully convey the scope of the application to those skilled in the art.

[0048] It should be noted that when an element is referred to as being "on" another element, it can be directly on the other element or intervening elements can also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements can also be present. The terms "inner," "outer," "left," "right," and similar terms are used herein only to describe the particular example embodiments and not to limit the scope of the application.

[0049] It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and "has" are inclusive and therefore specify the presence of 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 groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order in which they are described, unless specifically identified as an order dependent step. It is also to be understood that additional or alternative steps can be employed.

[0050] Although the terms first, second, third, etc. can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first", "second", and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

[0051] 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.

[0052] 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."

[0053] 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.

[0054] 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.

[0055] 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.

[0056] In this embodiment, such as Figures 7-8As shown, the main body support 10 includes a first side and a second side in the circumferential direction, wherein the first side and the second side each account for 180° in the circumferential direction, the first groove part 11 is arranged on the first side of the lumen support 100 and is recessed towards the inner side of the main body support 10, when the lumen support 100 is implanted in the blood vessel, the first side of the lumen support 100 corresponds to the large bending side of the aortic arch, so that the first groove part 11 corresponds to the ostia of the supra-aortic branches on the large bending side. The first inner branch 101 extends from the first groove part 11 towards the proximal end of the main body support 10, that is, the first inner branch 101 is arranged on the proximal end side of the first groove part 11, the first through hole 111 is arranged on the proximal end side of the first groove part 11, and the first through hole 111 communicates the first groove part 11 and the main cavity of the main body support 10, the size range of the first through hole 111 in the circumferential direction is 6mm-8mm, so as to facilitate the passage of the sheath core and the tip head 72, and at the same time not to be too large. The second through hole 112 is arranged on the distal end of the first groove part 11, and the second through hole 112 communicates the first groove part 11 and the main cavity of the main body support 10, the first through hole 111, the first groove part 11 and the second through hole 112 form an axial channel 1101 in the main body support 10 close to the first side. The axial channel 1101 is arranged at the position close to the first side of the main body support 10, which facilitates the passage of the sheath core in the delivery device, on the one hand, since the sheath core is attached to the large bending side of the arch with the delivery guide wire, the sheath core can be used in cooperation with the axial channel 1101 to make the sheath core drive the stent to conform to the bending shape of the arch, which facilitates the positioning of the first groove part 11 on the large bending side of the arch, and the first groove part 11 on the first side of the main body support 10 is directly corresponding to the ostia of the supra-aortic branches on the large bending side under the drive of the sheath core, which prevents the natural expansion of the stent from causing the slotting of the first groove part 11 to be covered by non-branch ostia, thereby affecting the selection of the branch guide wire into the inner branch ostia; on the other hand, since the hole type structure of the inner branch needs to be maintained before the branch stent is reconstructed, the axial ends of the inner branch need to be supported by the annular support 101a to maintain the hole type, taking the arch top of the aortic arch as a boundary, defining the part extending from the arch top towards the ascending aorta as the upper arch, and defining the part extending from the arch top (such as Figure 4 the middle transverse dashed line) towards the descending aorta as the lower arch, since the proximal end of the first groove part 11 is close to the ascending aorta direction, the sheath core at this position is in the inflection part (upper arch) of the arch, since the sheath core is in the inflection part of the upper arch, the connection between the sheath core and the tip head 72 is easily hooked by the annular supports at the two ends of the first inner branch 101 and the second inner branch 102, which may cause the released stent to be displaced towards the descending aorta, thereby affecting the retreat of the sheath core, therefore, the passage formed by the first inner branch 101, the second inner branch 102 and the first groove part 11 cannot be used as the axial channel 1101 for the sheath core to pass through.

[0057] As Figures 7-9 In combination with Figure 11As shown, the first recessed portion 11 further comprises a bottom 113 extending from the bottom edge of the first proximal covering film 110 towards the distal end to form an open distal end 114 of the first recessed portion 11. The tube cavity stent 100 further comprises a first support net cover 12 covering the first recessed portion 11, and the distal end of the first support net cover 12 comprises a free end 121 radially spaced from the open distal end 114 to form a second through hole 112. As shown Figure 9 In combination Figure 9a As shown, in the design of the first support net cover 12, the braided wires of the middle net cover portion (123) of the first support net cover 12 are staggered and overlapped to maintain the radial support force of the first support net cover 12 and to ensure the recessed space; the net cover portions on the two axial sides of the first support net cover 12 are designed as hooking structures 122, so that the first support net cover 12 has the function of preventing shortening in the axial direction. When the free end 121 is radially spaced from the open distal end 114, the width of the second through hole 112 is the same as the radial dimension of the first recess, so that when the sheath core passes through the axial channel 1101, the sheath core mainly positions the proximal end of the first recessed portion 11 through the first through hole 111, thereby positioning the proximal end of the first recessed portion 11 at the large bending side, and the distal end of the first recessed portion 11 is relatively free and is not limited by the sheath core and does not need to be twisted with the sheath core. For the case of relatively twisted arch, the inner branch of the proximal end of the first recessed portion 11 corresponds to the arch branch in the axial direction, while ensuring that the other parts of the first recessed portion 11 naturally conform to the arch and do not excessively twist in the circumferential direction, and the main stent 10 is more stable after being released; it can also prevent the braided wires on the first support net cover 12 from excessively twisting in the circumferential direction, causing the hooking structures 122 of the braided wires to be misaligned and stimulating the blood vessels.

[0058] In the present embodiment, the first recessed portion 11 is in the form of a distally open groove structure, and the first recessed portion 11 comprises a first proximal covering film 110 provided on the proximal side thereof, the first proximal covering film 110 comprises a first branch opening 110a and a second branch opening 110b corresponding to the inner branches, the first branch opening 110a and the second branch opening 110b are spaced apart on the first proximal covering film 110, and the first inner branch 101 and the second inner branch 102 are respectively provided in the first branch opening 110a and the second branch opening 110b. The first through hole 111 is provided between the first inner branch 101 and the second inner branch 102 and close to the first side of the main stent 10. Among them, the first through hole 111 is in the form of a “cross” opening, provided on the first proximal covering film 110 and close to the middle line of the first side (in the present embodiment, the middle line of the first side refers to the line connecting the two ends of the first side in the circumferential direction) 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] In the embodiment, the bottom 113 of the first recessed part 11 comprises a recessed support 1131 and a recessed cover film 1132 covering the recessed support 1131, and the main body stent 10 comprises main body wave loops 13 arranged at intervals in the axial direction, and the recessed support 1131 is integrally formed with the main body wave loop 13 adjacent thereto in the circumferential direction, as shown in Figures 22-23 The main body wave loop 13 comprises a half-wave loop 131 and a complete circular loop 132, wherein the half-wave loop 131 is arranged on the main body stent 10 corresponding to the first recessed part 11, and the complete circular loop 132 is arranged on the main body stent 10 not corresponding to the first recessed part 11, and the half-wave loop 131 is adjacent to the recessed support 1131 in the circumferential direction, and the half-wave loop 131 and the recessed support 1131 can be a two-part wave structure to form a D-shaped tube, or can be an integrally formed wave structure to form a D-shaped tube, as shown in Figures 22-27 .

[0069] Since the recessed cover film 1132 is a secondary cut film relative to the main body cover film 14, the secondary cut recessed cover film 1132 needs to be sewn to the main body cover film 14 of the main body stent 10, the half-wave loop 131 can be arranged outside the main body cover film 14, and the recessed support 1131 is sewn to the inside of the recessed cover film 1132, so that the side of the recessed cover film 1132 close to the first side is a smooth surface, which can avoid the branch guide wire being hooked on the recessed support 1131 when the branch guide wire passes through the first recessed part 11 to select the internal branch; since the distal end of the recess has a certain length of the main body stent part, it is extremely difficult to integrally form the recessed support 1131 and the main body wave loop 13 adjacent thereto in the circumferential direction and then sew the wave part of the recessed support 1131 to the inside of the recessed cover film 1132, therefore, the recessed support 1131 and the half-wave loop 131 are both separate structures in the prior art, and in the prior art, the recessed support 1131 is sewn to the recessed cover film 1132, and then the recessed cover film 1132 with the recessed support 1131 is sewn to the main body cover film 14. In the embodiment, the distal end of the first recessed part is arranged as an open distal end, which facilitates the subsequent integrally forming of the recessed support 1131 on the first recessed part and the main body wave loop 13 adjacent thereto in the circumferential direction without increasing the difficulty of sewing, improving the overall performance of the stent without increasing the labor cost; in addition, as shown in Figure 10As shown, the axial length L1 of the main support 10 satisfies: 70mm≤L1≤90mm; the axial length L11 of the first groove part 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 the first support net cover 12 is connected with the open distal end 114 or is arranged radially spaced apart, the first groove part 11 prolongs the anchoring length of the main support 10 on the ascending aorta, so that the anchoring length of the main support 10 is not limited by the length of the ascending aorta, the anchoring reliability of the main support 10 is increased, and the main support 10 will not span the entire arch. For the case that the arch is relatively twisted, the possibility that the transition twisting of the braided wire on the first support net cover 12 in the circumferential direction causes the dislocation of the hooking part of the braided wire to stimulate the blood vessel can also be reduced.

[0070] Since the size of the lumen stent 100 is generally 10%-20% larger than the size of the blood vessel in which it is implanted, the lumen stent 100 is generally extruded by the blood vessel after being implanted in the blood vessel, and the half-wave coil 131 and the groove support 1131 form a D-shaped wave, which is integrally formed to enable sufficient support force at the D-shaped inflection point. As shown, Figures 22-27 so that the wave-shaped support of the groove support 1131 itself extends along the wave shape in the direction of the wave shape (such as Figure 23When the main body stent 10 is compressed in the opposite direction of the arrow (as shown in the arrow direction), the space form of the first groove part 11 in the groove height direction can be maintained, and the recess support 1131 cannot be recessed toward the lumen center to cause the main cavity cross-sectional area to become smaller, or protrude away from the lumen center to block the inner branch opening and cause the branch blood vessel to be ischemic. In other embodiments, the wave structure formed at the connection between the recess support 1131 and the half-wave coil 131 is a first connection wave 1320, the middle wave unit of the recess support 1131 except the two ends is a 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 a wave rod at one end of the half-wave coil 131, and the second wave rod 11311 is a wave rod at one end of the recess 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, and the third wave rod 11312 and the fourth wave rod 11313 are both wave rods of the recess 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, so as to ensure that when the main body stent 10 is radially compressed, the supportability of the first connection wave 1320 is greater than that of the second connection wave 1131a, that is, there is greater support force at the inflection point of the D-shaped wave relative to the wave extension direction of the recess support 1131, so that the second connection wave 1131a of the recess support 1131 itself is slightly compressed on the D-shaped plane, rather than the position of the recess support 1131 relative to the first connection wave 1320 being recessed toward the lumen center or protruding away from the lumen center, so as to maintain the space form of the first groove part 11 in the groove height direction, prevent the recess support 1131 from being recessed toward the lumen center to cause the main cavity cross-sectional area of the main body stent 10 to become smaller, or protruding away from the lumen center to block the inner branch opening and cause the branch blood vessel to be ischemic; and can also make the bottom 113 of the first groove part 11 conform to the shape of the proximal end of the extension stent 20 when the extension stent 20 is arranged inside the distal end of the main body stent 10 to be anchored with the main body stent 10, so that the two better match.

[0071] 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.

[0072] 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.

[0073] 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 by, The tubular stent comprises a main stent, a first inner branch and a first groove portion; the main stent comprises a first side and a second side in the circumferential direction, the first groove portion is arranged on the first side and recessed towards the inner side of the main stent, and the first inner branch extends from the first groove portion towards the proximal end of the main stent; the first groove portion comprises a first proximal end covering film, a bottom portion and an open distal end, the first proximal end covering film is arranged on the proximal end side of the first groove portion, the first proximal end covering film comprises a first branch opening, the first branch is arranged in the first branch opening, the bottom portion extends from the bottom edge of the first proximal end covering film towards the distal end to form the open distal end, so that the first groove portion has a distal end opening groove structure; the tubular stent further comprises a first support net cover arranged on the first groove portion, and the distal end portion of the first support net cover is connected with the open distal end or arranged radially spaced apart.

2. The intraluminal stent of claim 1, wherein, The bottom portion comprises a groove support and a groove covering film arranged on the groove support; the main stent comprises main wave coils arranged axially spaced apart, and the groove support is integrally formed with the circumferentially adjacent main wave coil.

3. The intraluminal stent of claim 1, wherein, The distal end of the first support net cover comprises a free end, and the free end is arranged radially spaced apart from the open distal end; Or, the distal end of the first support net cover comprises an extension portion, and the extension portion is bent and extended towards the central axis direction of the tubular stent, so as to be connected with the open distal end.

4. The intraluminal stent of claim 1, wherein, The tubular stent further comprises a first through hole and a second through hole, the first through hole is arranged on the proximal end side of the first groove portion and communicates with the first groove portion, the second through hole is arranged on 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 tubular stent close to the first side.

5. The intraluminal stent of claim 4, wherein, The tubular stent further comprises a second inner branch, and the first inner branch and the second inner branch are arranged spaced apart on the first proximal end covering film; the first through hole is arranged between the first inner branch and the second inner branch.

6. The intraluminal stent of claim 5, wherein, The distance between the first inner branch and the second inner branch gradually increases in the direction from the distal end to the proximal end.

7. The intraluminal stent of claim 1, wherein, The tubular stent further comprises an extension stent, and the proximal end of the extension stent is arranged in the main stent from the distal end of the main stent.

8. The intraluminal stent of claim 7, wherein, The extension stent comprises a second groove portion and a third inner branch, the second groove portion comprises a second proximal end covering film, and the third inner branch extends from the first proximal end covering film towards the proximal end or the distal end.

9. The intraluminal stent of claim 2, wherein, The groove support and the circumferentially adjacent main wave coil form a D-shaped wave structure.

10. The intraluminal stent of claim 1, wherein, The axial length L1 of the main stent satisfies: 70mm≤L1≤90mm.

11. The intraluminal stent of claim 10, wherein, The axial length L11 of the first groove portion satisfies: 30mm≤L11≤40mm.

12. A stent system comprising the luminal stent of any one of claims 1-11, wherein, The stent system comprises a first delivery device, the first delivery device comprises a handle assembly, a sheath core assembly and a tip head, the tip head is connected to one end of the sheath core assembly away from the handle assembly, and the sheath core assembly is arranged in the main cavity of the main stent and passes out from the proximal end of the main stent.

13. A stent system comprising the luminal stent of any one of claims 4-6, wherein, The stent system includes a first delivery device including a handle assembly, a sheath core assembly, and a tip head connected to an end of the sheath core assembly distal from the handle assembly, the tip head being passable along the axial passage out of the proximal end of the main body stent.

Images