Covered stent and conveying system
By designing a coated stent, the connection between the lateral collar and the main stent is solved, and the internal leakage problem caused by the connection between the branches and the main stent in interventional treatment is improved, and the reliability and effectiveness of the treatment are improved.
Patent Information
- Application Number
- CN202311579779.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-11-22
- Publication Date
- 2025-05-23
AI Technical Summary
Among the existing interventional treatment methods, the internal leakage problem caused by the connection between the branches and the main stent is more serious, which affects the treatment effect and reliability.
A coated bracket is designed, including a body bracket and a side branch connected thereto, which comprises at least a long or short branch, through which the connection with the body bracket is formed into an integrated structure or anchoring area to reduce the risk of internal leakage.
Through the design of the coating stent, the internal leakage between the main stent and the treatment branch is effectively prevented, the axial effect between the treatment branch and the coating stent is improved, and the probability of internal leakage is reduced.
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Figure CN120022113A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of medical devices, and in particular to a stent graft and a delivery system. Background Art
[0002] Aortic arch diseases mainly include aortic aneurysms or aortic dissections that invade the aortic arch. The biggest difficulty in endovascular treatment is that while isolating the aneurysm and dissection rupture, it is necessary to preserve the important branch arteries of the aortic arch, including the innominate trunk, left common carotid artery, left subclavian artery, variant vertebral artery and aberrant right subclavian artery. Currently, the more commonly used methods in clinical practice include: hybrid surgery, chimney or periscope technology, and extracorporeal fenestration.
[0003] Under current technology, hybrid surgery has the advantages of open-chest surgery, such as intuitiveness, easy operation and good positioning, but open-chest surgery is more traumatic. In comparison, interventional treatment has the advantages of less trauma, simplicity, safety, effectiveness, fewer complications and significantly shorter hospital stay.
[0004] The chimney or periscope technology of interventional treatment establishes a branch pathway by overlapping the branch stent with the main stent. However, there is a long-term squeezing effect between the main and branch stents, resulting in poor long-term patency rate. More importantly, the overlapping gap cannot be avoided, and the risk of internal leakage is high.
[0005] The fenestration procedures for interventional treatment are divided into in situ fenestration and in vitro pre-fenestration. Both of them use the stents produced by medical device manufacturers beyond their applicable scope, destroying the original shape of the stent. The biggest difficulty in the fenestration procedure lies in how to make the branch highly consistent with the main body. The window of the in vitro pre-fenestration is often larger, which is more conducive to positioning, and the risk of membrane rupture in in situ fenestration is also high. What is more critical is that the blood flow is blocked only by the interference contact between the membrane of the main stent and the branch, which has the problem of internal leakage and reliability is difficult to guarantee.
[0006] Although the above-mentioned interventional treatment methods can achieve the purpose of blocking the rupture of aortic disease and ensuring the patency of the branches, the risk of branch internal leakage is high and the reliability is poor. Summary of the invention
[0007] The present invention aims to solve the problem of internal leakage caused by the connection between the branch and the main stent in the existing interventional treatment methods. In view of this, the present invention provides a coated stent and a delivery system.
[0008] The present invention solves the technical problem by the following technical solutions:
[0009] The first technical solution of the present invention provides a coated stent, comprising a main stent and a side branch connected to the main stent, the side branch comprising a first end and a second end opposite to each other along its axial length, the side lumen of the side branch being connected to the main lumen of the main stent; the side branch comprises at least a long branch having a first axial length and / or a short branch having a second axial length, the first axial length being greater than the second axial length; wherein, when the side branch includes the long branch, the first end of the long branch is connected to the tube wall of the main stent, the second end of the long branch extends outside the main lumen, and the long branch is used as a treatment branch; when the side branch includes the short branch, the first end of the short branch is connected to the tube wall of the main stent, the second end of the short branch extends in the main lumen and / or outside the main lumen, and the short branch is used to connect with an external treatment branch.
[0010] In some embodiments of the present invention, when the side branch includes a short branch, the short branch at least includes an embedded short branch located in the main lumen, the first end of the embedded short branch is connected to the tube wall of the main stent, and the second end of the embedded short branch extends in the main lumen of the main stent.
[0011] In some embodiments of the present invention, the second end of the embedded short branch extends toward the central axis of the main support or the distal end of the main support, and the angle between the axis of the embedded short branch and the central axis of the main support is less than or equal to 90°.
[0012] In some embodiments of the present invention, the port at the second end of the embedded short branch is configured as an inclined port that is inclined relative to the central axis of the main support.
[0013] In some embodiments of the present invention, along the direction from the distal end of the main body stent toward the proximal end, the distance between the inclined opening and the central axis of the main body stent in the radial direction gradually decreases.
[0014] In some embodiments of the present invention, a through hole for a guide wire to pass through is provided on the tube wall of the embedded short branch close to the proximal end of the main stent.
[0015] In some embodiments of the present invention, the short branch also includes an external short branch located outside the main cavity, the first end of the external short branch is connected to the tube wall of the main support, and the second end of the external short branch extends outside the main cavity of the main support.
[0016] In some embodiments of the present invention, the external short branch is coaxially arranged with the internal short branch, and the side lumen of the coaxially arranged external short branch is communicated with the side lumen of the internal short branch.
[0017] In some embodiments of the present invention, the short branch includes an external short branch located outside the main lumen, the first end of the external short branch is connected to the tube wall of the main support, and the second end of the external short branch extends outside the main lumen of the main support.
[0018] In some embodiments of the present invention, when the side branch includes a short branch, the short branch is configured as an equal-diameter or non-equal-diameter setting along the axial direction of the short branch; wherein, when the short branch is configured as a non-equal-diameter setting, at least a portion of the short branch is in a reduced diameter shape along its own axial direction.
[0019] In some embodiments of the present invention, the diameter of the first end of the short branch is smaller than the diameter of the second end, or,
[0020] The diameter of the first end of the short branch is larger than the diameter of the second end thereof.
[0021] In some embodiments of the present invention, the long branch and / or the short branch include a plurality of wave coils arranged in sequence along their own axial length, and any of the wave coils includes a plurality of wave structures connected end to end along the circumferential direction; wherein, at least the wave height in the proximal region and / or the distal region of the wave coils close to their respective first ends is smaller than the wave height in other regions of the same wave coil.
[0022] In some embodiments of the present invention, at least the wave circle close to each first end is located in the proximal area or the distal area with a low wave, the area on the other side radially opposite thereto is a high wave, and other areas in the same wave circle are transition waves connecting the high wave and the low wave, and the waveform height of the transition wave gradually decreases from the high wave to the low wave.
[0023] In some embodiments of the present invention, the main body support includes a first wave coil and multiple second wave coils, the first wave coil is located at the distal end of the main body support relative to the second wave coil; the first end of the long branch and / or the short branch is connected to the tube wall of the main body support between the first wave coil and the second wave coil adjacent to the first wave coil; and / or the first end of the long branch and / or the short branch is connected to the tube wall of the main body support between two adjacent second wave coils located on the farthest end side.
[0024] In some embodiments of the present invention, the second axial length of the short branch is in a range of 3 mm to 7 mm.
[0025] The first technical solution of the present invention provides a delivery system, comprising the coated stent described in the first technical solution and a delivery assembly for delivering the coated stent to a preset position, the delivery assembly comprising a delivery handle and a delivery sheath extending from the proximal end of the delivery handle, the delivery system also comprising a pre-buried guide wire, the distal end of the pre-buried guide wire extending into the main lumen of the main stent and then passing through the side lumen of the side branch, the coated stent and the pre-buried guide wire passing through the coated stent are assembled in the delivery sheath, the proximal end of the pre-buried guide wire extends from the delivery handle, and when the delivery sheath is withdrawn, the distal end of the pre-buried guide wire is configured to enter a preset branch.
[0026] According to the stent graft of the present invention, by setting a side branch connected to the main stent on the main stent, when the side branch includes a long branch, the long branch is directly used as a treatment branch, and the main stent and the long branch will not leak internally at the interface between the two due to the integrated structure. When the side branch includes a short branch, the short branch is used to connect with the external treatment branch, increasing the anchoring area, improving the effective distance and contact area of the treatment branch and the stent graft, and greatly reducing the probability of internal leakage. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:
[0028] Figure 1 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0029] Figure 2 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0030] Figure 3 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0031] Figure 4 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0032] Figure 5 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0033] Figure 6 Schematically shows Figure 5 A magnified schematic diagram of part A;
[0034] Figure 7 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0035] Figure 8The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0036] Fig. 9 Schematically shows Figure 8 A magnified schematic diagram of part B;
[0037] Fig.10 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0038] Fig.11 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0039] Fig.12 The structure diagram of the short branch of one embodiment of the present invention is schematically shown;
[0040] Fig.13 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0041] Fig.14 The structure diagram of a stent graft according to an embodiment of the present invention is schematically shown;
[0042] Fig.15 A schematic diagram of a partial structure of a stent graft according to an embodiment of the present invention is schematically shown;
[0043] Fig.16 The schematic diagram shows a delivery system according to an embodiment of the present invention implanting a covered stent into the aorta.
[0044] The symbols in the accompanying drawings are as follows:
[0045] 100. Covered stent;
[0046] 10. Main frame; 11. First wave ring; 12. Second wave ring;
[0047] 20, side branch; 201, first end; 202, second end; 203, wave ring; 2031, high wave; 2032, low wave; 2033, transition wave; 21, short branch; 211, embedded short branch; 2111, through hole; 212, external short branch; 2101, inclined mouth; 22, long branch; 213, developing ring;
[0048] 30. Bare stent; 31. Development piece;
[0049] 200. Delivery system; 2001. Treatment branch; 2002. Pre-buried guide wire. Specific embodiments
[0050] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, specific embodiments of the present invention are now described in detail with reference to the accompanying drawings.
[0051] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.
[0052] It should be understood that the terms used in the text are only for the purpose of describing specific example embodiments, and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used in the text may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described in the text are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.
[0053] Although the terms first, second, third, etc. can be used in the text 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 can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the exemplary embodiment.
[0054] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will 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 can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.
[0055] It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used terms in the field of interventional medical devices, where "distal" refers to the end away from the operator during surgery, and "proximal" refers to the end close to the operator during surgery. Axial refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; radial refers to the direction perpendicular to the above axial direction. For example, Figure 1 or Figure 2 For example, one end of the bare stent 30 is the distal end, and the other end opposite thereto is the proximal end.
[0056] like Figure 1 , Figure 2 and Figure 3 As shown, the present invention exemplarily provides a stent graft 100, the stent graft 100 includes a main stent 10 and a side branch 20, the side branch 20 is located at the side of the main stent 10, and the side branch 20 is connected to the main stent 10, the main stent 10 and the side branch 20 are both tubular structures with inner lumens, the main stent 10 has a main lumen, the side branch 20 has a side lumen, and the main lumen of the main stent 10 is connected to the side lumen of the side branch 20. The structure of the stent graft 100 of the present invention will be described in detail below.
[0057] As an embodiment, the side branch 20 in the exemplary covered stent 100 of the present invention has a longer extension length, the side branch 20 is integrally provided with or sealedly connected to the main stent 10, and the side branch 20 is directly used as a treatment branch 201 and implanted in a branch vessel of the aortic arch (see Fig.16) to quickly establish the supra-arch branch pathway. This method not only prevents internal leakage, but also the whole process is simple to operate and the operation time is short. It should be understood that in this method, multiple side branches 20 can be set as needed. As another embodiment, the side branch 20 in the exemplary coated stent 100 of the present invention has a shorter extension length. The side branch 20 is used as an anchoring branch to connect with the external treatment branch 2001, so as to complete the establishment of the supra-arch branch pathway, wherein the anchoring side branch 20 is integrally arranged with the main stent 10 or sealedly connected. This method not only solves the problem of internal leakage, but also the side branch 20 is more applicable to the treatment branch, and the requirements for conditions such as the distance between branches, the branch twisting angle, and the size of the branch opening are greatly reduced. It should be understood that in this method, multiple side branches 20 can be set as needed. As another embodiment, the side branches 20 in the exemplary covered stent 100 of the present invention include multiple side branches 20, some of which have longer extension lengths and some have shorter extension lengths. The multiple side branches 20 are integrally arranged with the main stent 10 or sealedly connected. The side branches 20 with longer extension lengths are directly used as treatment branches 2001 and implanted in the branch blood vessels of the aortic arch, thereby preventing internal leakage and simplifying the operation and shortening the operation time; while the side branches 20 with shorter extension lengths are used as anchoring branches to connect with the external treatment branches 2001, thereby completing the establishment of the branch pathway on the arch, which greatly improves the scope of application of the product while solving the problem of internal leakage and reduces the restrictions on the applicable conditions of the product. Among them, the multiple in the present invention refers to two or more, and it should be understood that in this combination, multiple long branches and short branches can be set as needed.
[0058] It should be noted that the treatment branch described in the present invention refers to a branch stent used to reconstruct the branch vessels of the aortic arch, and the branch vessels of the aortic arch include the brachiocephalic trunk, the left common carotid artery, the left subclavian artery, etc. The objects in the "integrated" and "split" described in the present invention refer to the covered stent.
[0059] The coated stent of the present invention is provided with a side branch connected to the main stent on the main stent. When the side branch includes a long branch, the long branch is directly used as a treatment branch, and the main stent and the long branch will not leak internally at the interface between the two due to the integrated structure. When the side branch includes a short branch, the short branch is used to connect with the external treatment branch, increasing the anchoring area, improving the effective distance and contact area of the treatment branch and the coated stent, improving the sealing between the main stent and the treatment branch, and greatly reducing the probability of internal leakage.
[0060] Continue to refer to Figure 1 to Figure 3Exemplarily, the side branch 20 of the stent graft 100 includes a long branch 22 having a first axial length, or the side branch 20 includes a short branch 21 having a second axial length, or the side branch 20 includes both a long branch 22 having a first axial length and a short branch 21 having a second axial length, wherein the first axial length is greater than the second axial length. Preferably, the range value of the first axial length is 20 mm to 60 mm. The range value of the second axial length is 3 mm to 7 mm. This range of values of the second axial length not only meets the anchoring length requirements, avoids internal leakage, avoids excessive length, and reduces the sheathing volume; at the same time, it avoids the side branch occupying too much internal space of the main cavity of the main stent when the side branch is embedded. It can be understood that the number and setting method of the side branch 20 can be selected and combined according to actual needs. Exemplarily, when the coated stent 100 is provided with two or more side branches, the multiple side branches 20 can all be set as long branches 22 and used as treatment branches 2001, so that the long branches 22 are directly implanted and reconstruct the branch blood vessels of the aortic arch; or, the multiple side branches 20 can all be set as short branches 21 and used as embedded / external short branches, so that the short branches 21 are used to connect with the external treatment branches 2001; or, some of the multiple side branches 20 are set as long branches 22 and used as treatment branches 2001, and the remaining parts are set as short branches 21 and used as embedded / external short branches.
[0061] Combination Figure 1 to Figure 3 As shown, along the axial length direction of the side branch 20, the side branch 20 includes a first end 201 and a second end 202 opposite to each other. When the side branch 20 is configured as a long branch 22, the first end 201 of the long branch 22 is connected to the tube wall of the main stent 10, and the second end 202 of the long branch 22 extends outside the main lumen of the main stent 10. When the side branch 20 is configured as a short branch 21, the two ends of the short branch 21 in the axial length direction are respectively the first end 201 and the second end 202, the first end 201 is connected to the tube wall of the main stent 10, and the second end 202 extends inside or outside the lumen of the main lumen.
[0062] Furthermore, if Figure 2 When the side branch 20 includes a short branch 21, the short branch 21 at least includes an embedded short branch 211 located in the main lumen, the first end 201 of the embedded short branch 211 is connected to the wall of the main stent 10, and the second end 202 of the embedded short branch 211 extends in the main lumen of the main stent 10. Or, Figure 3 The short branch 21 includes an external short branch 212 located outside the main body lumen, the first end 201 of the external short branch 212 is connected to the wall of the main body stent 10, and the second end 202 of the external short branch 212 extends outside the main lumen of the main body stent 10. It is also possible that Figure 4 , Fig.13 and Fig.14 As shown, when the side branch 20 includes a short branch 21, the short branch 21 includes both an embedded short branch 211 located in the main lumen and an external short branch 212 located outside the main lumen. The first end 201 of the embedded short branch 211 is connected to the tube wall of the main stent 10, and the second end 202 of the embedded short branch 211 extends in the main lumen of the main stent 10. The first end 201 of the external short branch 212 is connected to the tube wall of the main stent 10, and the second end 202 of the external short branch 212 extends outside the main lumen of the main stent 10. The embedded short branch 211 can be set coaxially or non-coaxially with the external short branch 212. When the external short branch and the embedded short branch are coaxially arranged, the side lumen of the coaxially arranged external short branch is connected to the side lumen of the embedded short branch. For example, as Figure 4 As shown, when the embedded short branch 211 and the external short branch 212 are coaxially arranged, the embedded short branch 211 is inclined and the port is facing the distal end, and the external short branch 212 is also inclined, and the two are inclined in opposite directions. At the same time, the proximal side of the external short branch 212 is low wave, and the external short branch 212 is folded and sheathed along the S1 direction, and the distal side of the embedded short branch 212 is low wave, and the embedded short branch 212 is folded and sheathed along the S2 direction. In this way, on the one hand, the anchoring length of the short branch can avoid the embedded length from being too long to occupy the internal space of the main stent through the embedded and external methods, which is more in line with the hemodynamics. On the other hand, the staggered folding sheath avoids increasing the sheathing volume. When the through hole 2111 is set on it, the guide wire is further prevented from bending "over the mountain". It should be understood that the number, combination and arrangement position of the long branch 22, the embedded short branch 211 and the external short branch 212 can be selectively set according to actual needs.
[0063] Exemplary, combined Figure 2 and Figure 4 As shown, the second end 202 of the embedded short branch 211 extends toward the central axis X1 of the main support 10 or the distal end of the main support 10, and the angle between the axis X2 of the embedded short branch 211 and the central axis X1 of the main support 10 is less than or equal to 90°, that is, the angle α in the figure is less than or equal to 90°. In this embodiment, the extension direction of the second end 202 is limited so that the embedded branch port is more compliant with hemodynamics, increases brain perfusion and reduces thrombosis, and avoids or reduces blood flow back to the branch.
[0064] For further information, please refer to Figures 4 to 9 As shown, the port of the second end 202 of the embedded short branch 211 is configured as an inclined opening that is inclined relative to the central axis X1 of the main stent 10. The setting of the oblique cut can effectively reduce the volume of the short branch, and can better fold with the inner wall of the main stent 10 to sheath, reduce the sheath volume, and reduce the excessive internal volume occupied by the embedded short branch. In order to further comply with the hemodynamics, such as Figures 4 to 6 As shown, along the direction from the distal end of the main support 10 to the proximal end, the radial distance between the inclined mouth and the central axis X1 of the main support 10 gradually decreases. This method allows the blood flow to enter the branch more dynamically, increase brain perfusion, reduce thrombosis, and reduce blood flow back to the branch.
[0065] See also Figure 4 and Figure 7 As shown, in one embodiment, a through hole 2111 is provided on the tube wall of the embedded short branch 211 near the proximal side of the main stent 10, through which the guide wire 2002 can pass. The provision of the through hole 2111 allows the guide wire 2002 to enter the side lumen of the embedded short branch 211 and pass out without bending around the port of the second end 202 of the embedded short branch 211, but can directly pass through the through hole 2111 on the side wall of the embedded short branch 211 and directly enter its lumen and pass through, thereby avoiding the problem of the guide wire 2002 bending and "climbing over the mountain", and facilitating assembly and pushing. The effect brought by the through hole 2111 is particularly prominent when the radial distance between the inclined port and the central axis X1 of the main stent 10 is gradually reduced from the distal end to the proximal end in order to reduce the branch volume and comply with the hemodynamics, which can achieve the purpose of reducing the branch volume, facilitating sheathing and complying with the dynamics, while avoiding the problem of the guide wire 2002 bending and "climbing over the mountain". Furthermore, the through hole 2111 is arranged close to the first end, so that after the anastomosis and anchoring, the treatment branch can cover the through hole.
[0066] For further information, see Figure 10 to Figure 12 On the basis of any of the above embodiments, in order to improve the anchoring effect, when the side branch 20 includes a short branch 21, the short branch 21 is configured to be equal-diameter or non-equal-diameter along the axial direction of the short branch 21; wherein, when the short branch 21 is configured to be non-equal-diameter, at least part of the short branch 21 is in a reduced diameter shape along its own axial direction. For example, Fig.10 As shown, the diameter of the first end 201 of the short branch 21 is greater than the diameter of the second end 202 thereof, and the embedded short branch 211 is in a funnel shape; or as shown in FIG. Fig.11 and Fig.12 As shown, the diameter of the first end 201 of the short branch 21 is smaller than the diameter of the second end 202, and the embedded short branch 211 is trapezoidal. Fig.12 As shown, a developing member 213 is provided on the first end 201 and the second end 202 of the short branch 21. In other embodiments, as Fig.12As shown, the short branch 21 includes a plurality of coils spaced apart along its axial length direction, and a connecting rod 214 is provided between two adjacent coils. Preferably, the connecting rod 214 is tilted relative to the central axis of the short branch 21, and one end of the connecting rod 214 is connected to the trough of the previous coil, and the other end is staggeredly connected to the crest of the adjacent coil. Preferably, the connecting rod 214 is compressible and self-expandable along the axial direction of the short branch 21, for example, the connecting rod 214 is S-shaped or inverted S-shaped, and the two protruding ends of the S-shaped are respectively facing the proximal end and the distal end, so that it can be compressed and self-expandable. An S-shaped or inverted S-shaped connecting rod 214 is added between the coils of the short branch 21, and the S-shaped structure retains the scalability in the longitudinal direction, which increases the flexibility during assembly; at the same time, due to the memory of the nickel-titanium wire, it can be naturally expanded after being released in the blood vessel to ensure the effective anchoring area of the embedded short branch, and ensure sufficient anchoring with the external treatment branch stent. For example, if the normal short branch is 3 mm to 7 mm, the wave circle may be shortened or overlapped without a connecting rod, resulting in insufficient effective anchoring area, reducing the anchoring area with the external treatment branch and increasing the risk of internal leakage. However, the connecting rod 214 can ensure that after release, the short branch 21 is expanded due to the self-expansion of the connecting rod 214, effectively ensuring the anchoring length and avoiding the internal leakage problem caused by insufficient anchoring. Figure 1 and Figures 4 to 9 As shown, the long branch 22 and / or the short branch 21 each include a plurality of wave coils sequentially arranged along their own axial length, and any wave coil includes a plurality of wave structures connected end to end along the circumferential direction; wherein, at least the wave coils close to their respective first ends 201, in the proximal region and / or the distal region, have a wave height that is smaller than the wave height in other regions of the same wave coil. The arrangement of high and low waves ensures that during assembly, the bending side will not form a strong support, which facilitates assembly, and at the same time, the connection has good flexibility, and the adaptability of the passage establishment is higher. Preferably, at least the wave coils close to their respective first ends 201, in the proximal region or the distal region, have low waves, and the region on the other side radially opposite thereto has high waves, and other regions in the same wave coil have transition waves connecting high waves and low waves, and the wave height of the transition wave gradually decreases from high waves to low waves. As shown Figure 1 As shown, the "integrated" branch stent takes into account the anatomical structure of the aortic arch, where the left subclavian artery (LSA) originates from the posterior position. The integrated branch is designed to conform to its shape and to be a structure originating from the posterior position. Due to the inclined root of the LSA, the waveform is also improved to a low wave in the proximal region and a high wave in the distal region, thereby reducing the pulling of the distal end of the main stent by the curvature of the blood vessel after the branch is implanted in the LSA, thereby avoiding internal leakage of the distal end of the main stent.
[0067] like Figure 1 and Figure 2As shown, the main support 10 includes a first wave ring 11 and a plurality of second wave rings 12, the first wave ring 11 is located at the distal end of the main support 10 relative to the second wave ring 12; the first end 201 of the long branch and / or the short branch 21 is connected to the tube wall of the main support 10 located between the first wave ring 11 and the second wave ring 12 adjacent to the first wave ring 11; and / or, the first end 201 of the long branch and / or the short branch 21 is connected to the tube wall of the main support 10 between two adjacent second wave rings 12 located at the most distal side. The long branch and / or the short branch 21 is arranged at the proximal end of the first wave ring 11 or the proximal end of the most distal second wave ring 12, which can avoid blocking the entrance of other branches located at the distal side when only a local arch passage is established.
[0068] The present invention also exemplarily provides a delivery system, including any of the above-mentioned coated stents and a delivery assembly for delivering the coated stent to a preset position, the delivery assembly including a delivery handle and a delivery sheath extending from the proximal end of the delivery handle, the delivery system also including a pre-buried guide wire 2002, the distal end of the pre-buried guide wire 2002 extends into the main lumen of the main stent 10 and then passes out from the side lumen of the side branch 20, the coated stent and the pre-buried guide wire 2002 passing through the coated stent are assembled in the delivery sheath, the proximal end of the pre-buried guide wire 2002 extends from the delivery handle, and when the delivery sheath is withdrawn, the distal end of the pre-buried guide wire 2002 is configured to enter the preset branch. Wherein, when a through hole 2111 is provided on the embedded short branch 211 of the coated stent, the pre-buried guide wire 2002 can enter the side lumen of the embedded short branch 211 through the through hole 2111 and pass out.
[0069] With the delivery system of the present invention, in operation, the coated stent is implanted into the descending main segment, the pre-buried guide wire is pushed until the pre-buried guide wire is positioned in the arch, and then the catcher is used to grab and pull it into the LSA lower positioning branch port, and then the main stent is positioned at the lesion, the main stent is released, and the branch is synchronously pulled by the pre-buried guide wire and implanted into the LSA. The secondary positioning and release of the branch stent are reduced, and the operation is simpler.
[0070] The technical solution of the present invention will be further described in detail below in conjunction with specific embodiments.
[0071] Embodiment 1
[0072] In this embodiment, Figure 2As shown, the stent graft 100 includes a main stent 10 and a side branch 20, the side branch 20 is configured as an embedded short branch 211, the first end 201 of the embedded short branch 211 is connected to the tube wall of the main stent 10, the second end 202 of the embedded short branch 211 extends in the main cavity, the extension direction of the second end 202 of the embedded short branch 211 in the main cavity points to the central axis X1 of the main stent 10, and the angle between the central axis X2 of the embedded short branch 211 and the central axis X1 of the main stent 10 is equal to 90°. In this embodiment, the embedded short branch 211 is used to connect with the external treatment branch 2001. By setting the embedded short branch 211, the anchoring area is increased, the connection distance and contact area between the stent graft 100 and the external treatment branch 2001 are increased, so that the sealing between the stent graft 100 and the external treatment branch 2001 is better, and the probability of internal leakage is reduced.
[0073] Reference Figures 4 to 9 Furthermore, the port of the second end 202 of the embedded short branch 211 is configured as an inclined opening 2101 inclined relative to the central axis X1 of the main stent 10. Exemplarily, along the direction from the distal end of the main stent 10 toward the proximal end, the radial spacing between the inclined opening 2101 and the central axis X1 of the main stent 10 gradually increases, so as to facilitate the guide wire to pass from the inclined opening 2101 into the embedded short branch 211, reduce the degree of bending of the guide wire when passing through the embedded short branch 211, and make the guide wire more compliant. It should also be noted that the inclined opening 2101 reduces the volume of the embedded short branch 211, which can better fold and sheath with the inner wall of the main stent 10, reduce the sheathing volume of the coated stent 100, and at the same time reduce the volume occupied by the embedded short branch 211 inside the main cavity.
[0074] Furthermore, in some embodiments, a through hole 2111 (not shown in the figure) for the guide wire to pass through is provided on the tube wall of the embedded short branch 211 close to the proximal side of the main support 10, so as to facilitate the guide wire to pass into the embedded short branch 211 from the through hole 2111, reduce the degree of bending of the guide wire when passing through the embedded short branch 211, and make the guide wire more compliant.
[0075] In some embodiments, the distance between the through hole 2111 and the first end 201 of the embedded short branch 211 is smaller than the distance between the through hole 2111 and the second end 202 of the embedded short branch 211, so that the through hole 2111 is arranged closer to the first end 201. On the one hand, the bending degree of the guide wire when it is passed through the embedded short branch 211 is further reduced. On the other hand, after the external treatment branch 2001 is connected to the embedded short branch 211, the external treatment branch 2001 can better block the through hole 2111 to avoid the problem of blood flowing into the embedded short branch 211 leaking through the through hole 2111, so as to increase blood perfusion to the branch blood vessels of the aortic arch.
[0076] Furthermore, if Figures 4 to 9 As shown, the embedded short branch 211 includes a plurality of corrugations 203 arranged in sequence along its axial length, and each corrugation 203 includes a plurality of wave structures connected end to end along the circumference of the embedded short branch 211 . The waveform height of the wave circle 203 located in the proximal side area / distal side area of the main stent 10 is smaller than the waveform height of other areas in the same wave circle, so that the connection between the embedded short branch 211 and the external treatment branch 2001 has better flexibility, so that the embedded short branch 211 is easier to bend to better conform to the access angle of the external treatment branch 2001, improve the fit between the embedded short branch 211 and the external treatment branch 2001, reduce the risk of internal leakage, and also make the embedded short branch 211 When the branch is bent toward the proximal side, the inner bending side of the embedded short branch 211 has better flexibility, so that the embedded short branch 211 can better fit the inner wall of the main stent 10 after bending, so that the overall compressed outer diameter of the coated stent 100 is smaller, the coated stent 100 is easier to sheath, and the passability of the coated stent 100 in the blood vessel during the intervention process is improved.
[0077] Furthermore, if Figure 8 and Fig. 9 As shown, among all the wave circles 203 of the embedded short branch 211, the waveform height in the area on the proximal side of the main stent 10 in each wave circle 203 is smaller than the waveform height in other areas of the same wave circle, so that the flexibility of the proximal side of the embedded short branch 211 is better, the flexibility of the connection between the embedded short branch 211 and the external treatment branch 2001 is further improved, and the overall compressed outer diameter size of the coated stent 100 is further reduced.
[0078] In other embodiments, Figures 4 to 6 As shown, at least the wave coil 203 of the first end 201 close to the embedded short branch 211 has a waveform height in the area on the distal side of the main support 10 that is smaller than the waveform height in other areas of the same wave coil, or the waveform height of the wave coil in the distal area or the proximal area is smaller than the waveform height in other areas of the same wave coil (not shown in the figure), so that the connection between the embedded short branch 211 and the external treatment branch 2001 has better flexibility, and also when the embedded short branch 211 is bent toward the distal side, the inner bending side of the embedded short branch 211 has better flexibility, so that the embedded short branch 211 can better fit the inner wall of the main support 10 after bending, so that the overall compressed outer diameter of the coated stent 100 is smaller, the coated stent 100 is easier to assemble, and the passability of the coated stent 100 in the blood vessel during the intervention process is improved.
[0079] In this embodiment, if Figures 4 to 9As shown, at least the wave circle 203 of the first end 201 close to the embedded short branch 211 is located in the proximal region or the distal region with low waves 2032, and the region on the other side radially opposite thereto is high waves 2031, and the other regions of the same wave circle 203 are transition waves 2033 connecting the high waves 2031 and the low waves 2032, and the waveform height of the transition wave 2033 gradually decreases from the high waves 2031 to the low waves 2032. By setting the structural form of the high waves 2031, the transition waves 2033 and the low waves 2032, the waveform height in the wave circle 203 gradually changes, and under the premise of satisfying the flexibility of the proximal region or the distal region of the embedded short branch 211, the support of the overall structure is taken into account, thereby improving the overall structural strength of the embedded short branch 211.
[0080] In this embodiment, the second axial length of the embedded short branch 211 is in the range of 3 mm to 7 mm. This length range can ensure the anchoring effect when connecting with the external branch, while avoiding the influence of occupying the internal space of the main cavity on the blood flow, and at the same time, reduce the overall compression diameter of the stent graft 100 as much as possible to facilitate assembly.
[0081] By setting the embedded short branch 211 in the main stent 10, then pulling the pre-buried guide wire 2002 to locate the branch opening, and finally implanting the external treatment branch 2001, that is, the branch stent and the embedded short branch 211 are anchored by interference fit, the embedded short branch 211 can conform to the vascular morphology without damaging the blood vessel and completely seal the branch opening of the branch stent. At the same time, it can also reduce the risk of displacement of the branch stent due to blood flow erosion.
[0082] Embodiment 2
[0083] In this embodiment, combined with Figure 5 As shown, the coated stent 100 includes a main stent 10 and a side branch 20, and the side branch 20 is configured as an embedded short branch 211. The first end 201 of the embedded short branch 211 is connected to the tube wall of the main stent 10, and the second end 202 of the embedded short branch 211 extends in the main cavity. The embedded short branch 211 is used to connect with the external treatment branch 2001. By setting the embedded short branch 211, the connection distance and contact area between the coated stent 100 and the external treatment branch 2001 are increased, so that the sealing between the coated stent 100 and the external treatment branch 2001 is better, and the probability of internal leakage is reduced.
[0084] In this embodiment, Figure 5 and Figure 6As shown, the second end 202 of the embedded short branch 211 points to the distal end of the main support 10 in the extension direction in the main cavity, and the angle between the central axis X1 of the embedded short branch 211 and the central axis X1 of the main support 10 is less than 90°. The embedded short branch 211 is tilted toward the distal end of the main support 10, so that the embedded short branch 211 is more in line with the direction of blood flow in the aorta from the ascending aorta to the descending aorta, so that the blood transported from the heart to the aorta can flow into the embedded short branch 211 through the port in a positive direction, thereby increasing the perfusion of the branch blood vessels of the aortic arch and reducing the probability of thrombosis, and avoiding the blood flow in the existing device from flowing into the branch support in a reverse manner.
[0085] Specifically, the port of the second end 202 of the embedded short branch 211 is configured as an inclined port 2101 inclined relative to the central axis X1 of the main support 10. Along the direction from the distal end of the main support 10 toward the proximal end, the radial spacing between the inclined port 2101 and the central axis X1 of the main support 10 gradually decreases, ensuring that the port of the embedded short branch 211 is facing the distal direction, making the port of the embedded short branch 211 more compliant with the hemodynamic direction, reducing the reverse blood flow pressure, and reducing the heart load.
[0086] Furthermore, if Figure 7 As shown, in some embodiments, a through hole 2111 for a guide wire to pass through is provided on the tube wall of the embedded short branch 211 near the proximal side of the main stent 10, so as to facilitate the guide wire to pass into the embedded short branch 211 from the through hole 2111, reduce the bending degree of the guide wire when passing through the embedded short branch 211, reduce the risk of excessive folding of the pre-embedded guide wire 2002 and damage to the stent and blood vessel, make the guide wire more compliant, and reduce the difficulty of establishing a pre-embedded guide wire 2002 passage for the pre-embedded guide wire 2002, which is beneficial to improve the probability of successful surgery.
[0087] In some embodiments, the distance between the through hole 2111 and the first end 201 of the embedded short branch 211 is smaller than the distance between the through hole 2111 and the second end 202 of the embedded short branch 211, so that the through hole 2111 is arranged closer to the first end 201. On the one hand, the bending degree of the guide wire when it is passed through the embedded short branch 211 is further reduced. On the other hand, after the external treatment branch 2001 is connected to the embedded short branch 211, the external treatment branch 2001 can better block the through hole 2111 to avoid the problem of blood flowing into the embedded short branch 211 leaking through the through hole 2111, so as to increase blood perfusion to the branch blood vessels of the aortic arch.
[0088] Furthermore, if Figure 6As shown, the embedded short branch 211 includes a plurality of wave circles arranged in sequence with an extended axial length, and each wave circle includes a plurality of wave structures connected end to end along the circumference of the embedded short branch 211 . At least the waveform height of the wave circle of the first end 201 close to the embedded short branch 211 in the area on the distal side of the main stent 10 is smaller than the waveform height of other areas in the same wave circle, so that the connection between the embedded short branch 211 and the external treatment branch 2001 has better flexibility, so that the embedded short branch 211 is easier to bend to better conform to the access angle of the external treatment branch 2001, improve the fit between the embedded short branch 211 and the external treatment branch 2001, reduce the risk of internal leakage, and also make the embedded short branch 211 When the branch is bent toward the distal side, the inner bending side of the embedded short branch 211 has better flexibility, so that the embedded short branch 211 can better fit the inner wall of the main stent 10 after bending toward the distal end, so that the overall compressed outer diameter of the coated stent 100 is smaller, the coated stent 100 is easier to assemble, and the passability of the coated stent 100 in the blood vessel during the intervention process is improved.
[0089] In this embodiment, the second axial length of the embedded short branch 211 is in the range of 3 mm to 7 mm. This length range can ensure the anchoring effect when connecting with the external branch, while avoiding the influence of occupying the internal space of the main cavity on the blood flow, and at the same time, reduce the overall compression diameter of the stent graft 100 as much as possible to facilitate assembly.
[0090] In this embodiment, if Figure 6 As shown, at least the wave circle of the first end 201 close to the embedded short branch 211 is located in the distal region with low waves 2032, the region on the other side radially opposite thereto is high waves 2031, and the other regions in the same wave circle are transition waves 2033 connecting the high waves 2031 and the low waves 2032, and the waveform height of the transition wave 2033 gradually decreases from the high wave 2031 to the low wave 2032. By setting the structural form of the high wave 2031, the transition wave 2033 and the low wave 2032, the waveform height in the wave circle is gradually changed, and the support of the overall structure is taken into account while satisfying the flexibility of the proximal region or the distal region of the embedded short branch 211, thereby improving the overall structural strength of the embedded short branch 211.
[0091] Embodiment 3
[0092] The differences between the third embodiment and the first and second embodiments will be described below, and the same or similar aspects between the third embodiment and the first and second embodiments will not be described in detail here.
[0093] In some embodiments, Figure 3As shown, the short branch 21 includes an external short branch 212 located outside the main cavity, the first end 201 of the external short branch 212 is connected to the tube wall of the main stent 10, and the second end 202 of the external short branch 212 extends outside the main cavity of the main stent 10. The external short branch 212 is used to connect with the external treatment branch 2001. By providing the external short branch 212, the connection distance and contact area between the stent graft 100 and the external treatment branch 2001 are increased, so that the sealing between the stent graft 100 and the external treatment branch 2001 is better, and the probability of internal leakage is reduced.
[0094] In some embodiments, the stent graft 100 includes an embedded short branch 211 and an external short branch 212. Exemplarily, the embedded short branch 211 and the external short branch 212 in the stent graft 100 are spaced apart along the axial direction of the main stent 10 (not shown in the figure), so that the embedded short branch 211 and the external short branch 212 are respectively connected to different external treatment branches 2001 to respectively reconstruct the branch vessels of two different aortic arches. For example, in some exemplary embodiments, the embedded short branch 211 is located at the distal side relative to the external short branch 212, then the embedded short branch 211 can be used to reconstruct the brachiocephalic trunk, while the external short branch 212 is used to reconstruct the left common carotid artery, or the embedded short branch 211 can be used to reconstruct the left common carotid artery, while the external short branch 212 is used to reconstruct the left subclavian artery. In other exemplary embodiments, the internal short branch 211 is located proximal to the external short branch 212, and the internal short branch 211 can be used to reconstruct the left common carotid artery, while the external short branch 212 is used to reconstruct the brachiocephalic trunk, or the internal short branch 211 can be used to reconstruct the left subclavian artery, while the external short branch 212 is used to reconstruct the left common carotid artery.
[0095] In some embodiments, Figure 4 As shown, the stent graft 100 includes an embedded short branch 211 and an external short branch 212, the external short branch 212 is coaxially arranged with the embedded short branch 211, and the side lumen of the coaxially arranged external short branch 212 is connected with the side lumen of the embedded short branch 211. By coaxially arranging the embedded short branch 211 and the external short branch 212 and respectively arranging them inside and outside the main lumen of the main stent 10, the overall structure formed by connecting the external short branch 212 and the embedded short branch 211 can prevent the branch opening from leaking in the direction outside the main lumen, and can also prevent the branch opening from leaking in the direction inside the main lumen. At the same time, the overall structure formed by connecting the external short branch 212 and the embedded short branch 211 has a longer branch anchoring area, which increases the anchoring force.
[0096] It should also be noted that in certain cases, such as when the dissection is near the branch but does not tear the branch blood vessels (such as the brachiocephalic trunk, the left common carotid artery, and the left subclavian artery), it is not necessary to reconstruct the branch blood vessels, and the external treatment branch 2001 is not required, and the operation can be completed using only the Chinese stent graft 100 of the present invention. The branch opening of the external short branch 212 establishes a branch blood vessel access pathway, and the branch opening of the internal short branch 211 ensures that the branch opening will not be occluded in the long term after being expanded.
[0097] Embodiment 4
[0098] The differences between the fourth embodiment and the first embodiment, the second embodiment and the third embodiment will be described below, and the same or similar aspects of the fourth embodiment to the first embodiment, the second embodiment and the third embodiment will not be described in detail here.
[0099] In some embodiments, please combine Figure 2 , Fig.10 , Fig.11 As shown, the short branch 21 includes an embedded short branch 211. Along the axial direction of the embedded short branch 211, the embedded short branch 211 is configured as an equal diameter or a non-equal diameter setting, wherein, when the embedded short branch 211 is configured as a non-equal diameter setting, at least a portion of the embedded short branch 211 in the axial direction is in a reduced diameter shape, and when the external treatment branch 2001 is connected to the embedded short branch 211, the reduced diameter area has a strong anchoring strength, thereby reducing the risk of the external treatment branch 2001 being displaced from the embedded short branch 211 due to blood flow flushing or other external force factors.
[0100] In some exemplary embodiments, Figure 2 and Fig.13 As shown, when the embedded short branch 211 and the external short branch 212 are configured to have equal diameters, the diameters of the first end 201 of the embedded short branch 211 and the first end 201 of the external short branch 212 are 10 mm, the diameters of the second end 202 of the embedded short branch 211 and the second end 202 of the external short branch 212 are 10 mm, and the lengths of the embedded short branch 211 and the external short branch 212 are 7 mm.
[0101] In some embodiments, Fig.10 , Fig.11 and Fig.14 As shown, the short branch 21 includes an external short branch 212. Along the axial direction of the external short branch 212, the external short branch 212 is configured as a non-equal diameter setting, and at least part of the axial direction of the external short branch 212 is in a reduced diameter shape. When the external treatment branch 2001 is connected to the external short branch 212, the reduced diameter area has a strong anchoring strength, which reduces the probability of the external treatment branch 2001 escaping from the external short branch 212 due to blood flow flushing or other external force factors.
[0102] Specifically, the specific shape structure of the embedded short branch 211 or the external short branch 212 can be set in various forms. For example, when the diameter reduction area is located at the first end 201 of the embedded short branch 211 or the first end 201 of the external short branch 212, or when the diameter reduction area is located at the second end 202 of the embedded short branch 211 or the second end 202 of the external short branch 212, the embedded short branch 211 or the external short branch 212 has a trumpet-shaped structure, a trapezoidal structure, etc. When the diameter reduction area is located in the middle area of the embedded short branch 211 along its own axial length direction, the embedded short branch 211 has a shape that is thin in the middle and thick at both ends, and when the diameter reduction area is located in the middle area of the external short branch 212 along its own axial length direction, the external short branch 212 has a shape that is thin in the middle and thick at both ends.
[0103] In some exemplary embodiments, Fig.10 As shown, the embedded short branch 211 has a funnel-shaped structure, the diameter of the first end 201 of the embedded short branch 211 is 8 mm, the diameter of the second end 202 of the embedded branch is 12 mm, the axial length of the embedded short branch 211 is 3 mm to 7 mm, and the taper of the embedded branch is set to 1 taper to 4 tapers.
[0104] In other exemplary embodiments, Fig.11 As shown, the embedded short branch 211 has a trapezoidal structure, the diameter of the first end 201 of the embedded short branch 211 is 12 mm, the diameter of the second end 202 of the embedded branch is 8 mm, the axial length of the embedded short branch 211 is 3 mm to 7 mm, and the taper of the embedded branch is set to 1 taper to 4 tapers.
[0105] In some embodiments, Fig.14As shown, the short branch 21 includes an embedded short branch 211 and an external short branch 212, the external short branch 212 is coaxially arranged with the embedded short branch 211, and the side lumen of the coaxially arranged external short branch 212 is connected to the side lumen of the embedded short branch 211, and the first end 201 of the embedded short branch 211 and the first end 201 of the external short branch 212 are in a reduced diameter shape, so that the whole formed by the embedded short branch 211 and the external short branch 212 has a smaller diameter size in the middle along the axial direction of itself than the diameter size of the two ends, on the one hand, the first end 201 of the embedded short branch 211 and the external short branch 212 are improved. The anchoring strength at the first end 201 of the branch 212, on the other hand, the second end 202 of the embedded short branch 211 and the second end 202 of the external short branch 212 are flared, which reduces the anchoring force at the non-contracted part (i.e., the second end 202 of the embedded short branch 211 and the second end 202 of the external short branch 212), which is beneficial to improving the torsional flexibility of the external treatment branch 2001 at the connection between the second end 202 of the embedded short branch 211 and the second end 202 of the external short branch 212, so that the external treatment branch 2001 can more easily conform to the structural morphology of the branch blood vessels of the aortic arch.
[0106] In some embodiments, Fig.12 As shown, at least one of the first end 201 and the second end 202 of the embedded short branch 211 is fixed with a developing ring 213 to facilitate positioning of the indication operation during surgery. At the same time, the radial force of the developing ring 213 maintains the shape of the embedded branch opening, thereby achieving a good supporting effect.
[0107] In some embodiments, at least one of the first end 201 and the second end 202 of the external short branch 212 is fixed with a developing ring 213 to facilitate positioning of indication operations during surgery. At the same time, the radial force of the developing ring 213 maintains the shape of the embedded branch opening, thereby achieving a good supporting effect.
[0108] Embodiment 5
[0109] The differences between the fifth embodiment and the first to fourth embodiments will be described below, and the same or similar aspects between the fifth embodiment and the first to fourth embodiments will not be described in detail here.
[0110] like Figure 1 As shown, the side branch 20 includes a long branch 22, a first end 201 of the long branch 22 is connected to the tube wall of the main stent 10, and a second end 202 of the long branch 22 extends outside the main cavity of the main stent 10. The long branch 22 serves as a treatment branch 2001, so that the long branch 22 can be directly implanted and reconstruct the branch blood vessels of the aortic arch. The integrated structure of the long branch 22 and the main stent 10 can effectively avoid the problem of internal leakage at the connection between the long branch 22 and the main stent 10.
[0111] In some embodiments, the side branch 20 includes a short branch 21 and a long branch 22 (not shown in the figure), and the long branch 22 and the short branch 21 in the stent graft 100 are arranged at intervals along the axial direction of the main stent 10, so that the long branch 22 and the short branch 21 are respectively connected to different external treatment branches 2001 to reconstruct the branch vessels of two different aortic arches. For example, in some exemplary embodiments, the long branch 22 is located at the distal side relative to the short branch 21, and the long branch 22 can be used to reconstruct the brachiocephalic trunk, while the short branch 21 is used to reconstruct the left common carotid artery, or the long branch 22 can be used to reconstruct the left common carotid artery, and the short branch 21 is used to reconstruct the left subclavian artery. In other exemplary embodiments, the long branch 22 is located at the proximal side relative to the short branch 21, and the long branch 22 can be used to reconstruct the left common carotid artery, while the short branch 21 is used to reconstruct the brachiocephalic trunk, or the long branch 22 can be used to reconstruct the left subclavian artery, while the short branch 21 is used to reconstruct the left common carotid artery.
[0112] In some embodiments, the side branch 20 includes two short branches 21 and one long branch 22, and the two short branches 21 and one long branch 22 are respectively arranged at intervals along the axial direction of the main stent 10. The two short branches 21 and one long branch 22 are respectively used to reconstruct the three branch blood vessels of the aortic arch. The arrangement order of the two short branches 21 and one long branch 22 along the axial direction of the main stent 10 can be arbitrarily combined and is not specifically limited here.
[0113] In this embodiment, if Figure 1 , Figure 2 and Fig.10 As shown, the main stent 10 includes a first wave ring 11 and a plurality of second wave rings 12, and the first wave ring 11 is located at the distal end of the main stent 10 relative to the second wave ring 12. The first end 201 of the side branch 20 is connected to the tube wall of the main stent 10 located between the first wave ring 11 and the second wave ring 12 adjacent to the first wave ring 11, or the first end 201 of the side branch 20 is connected to the tube wall of the main stent 10 located between two adjacent second wave rings 12 on the most distal side. When the side branch 20 is used to reconstruct the left subclavian artery without reconstructing the left common carotid artery and the brachiocephalic trunk, the above setting method allows the side branch 20 to be set as close to the distal end of the main stent 10 as possible, reducing the distance of the main stent 10 extending from the side branch 20 to the distal side, thereby reducing the probability of the main stent 10 blocking the entrance of the left common carotid artery after reconstructing the left subclavian artery.
[0114] Furthermore, the waveform height of the first wave circle 11 is smaller than the waveform height of the second wave circle 12, so that the radial supporting force of the first wave circle 11 is greater than the radial supporting force of the second wave circle 12. When implanting a branch blood vessel with a larger torsion angle, such as the left subclavian artery, the torsion angle between the externally connected treatment branch 2001 or the long branch 22 and the main stent 10 is larger. By increasing the radial supporting force of the first wave circle 11, the degree of deformation of the distal opening of the main stent 10 under the influence of the torsion angle between the treatment branch 2001 or the long branch 22 and the main stent 10 is reduced, so that the distal opening of the main stent 10 is more fully matched with the morphology of the aortic blood vessel, thereby reducing the probability of proximal internal leakage.
[0115] It should be noted that the side branch 20 may include only the long branch 22 or the short branch 21, or the side branch 20 may include the long branch 22 and the short branch 21. Specifically, when the side branch 20 includes the long branch 22 or the short branch 21, the first end 201 of the long branch 22 or the first end 201 of the short branch 21 is connected to the tube wall of the main support 10 located between the first wave circle 11 and the second wave circle 12 adjacent to the first wave circle 11. Alternatively, the first end 201 of the long branch 22 or the first end 201 of the short branch 21 is connected to the tube wall of the main support 10 located between the two adjacent second wave circles 12 on the farthest side.
[0116] When the side branch 20 includes a long branch 22 and a short branch 21, the first end 201 of the long branch 22 and the first end 201 of the short branch 21 are connected to the tube wall of the main stent 10 located between the first wave circle 11 and the second wave circle 12 adjacent to the first wave circle 11. Alternatively, the first end 201 of the long branch 22 and the first end 201 of the short branch 21 are connected to the tube wall of the main stent 10 located between two adjacent second wave circles 12 on the most distal side.
[0117] Embodiment 6
[0118] In this embodiment, if Figure 2 and Fig.15 As shown, the coated stent 100 also includes a bare stent 30, which is connected to the distal end of the main stent 10. The bare stent 30 includes at least one bare wave ring, and the maximum radial dimension of the bare wave ring is greater than the maximum radial dimension of the distal end of the main stent 10. The bare stent 30 is used to increase the anchoring strength between the coated stent 100 and the aorta at the distal side, thereby reducing the risk of displacement of the coated stent 100 in the aorta under blood flow flushing.
[0119] Furthermore, if Fig.15As shown, at least part of the bare stent 30 is coated, and a developing member 31 is arranged on the coating, and the developing member 31 includes but is not limited to a developing 8-shaped member, a developing ring 213, a developing wire, etc. By coating the bare stent 30, the developing member 31 is moved distally from between the first wave ring 11 and the second wave ring 12 to the coated area where the bare stent 30 is located, so that the side branch 20 is arranged between the first wave ring 11 and the second wave ring 12, so that a small distance can be maintained between the first wave ring 11 and the second wave ring 12, so that the main stent 10 maintains better anchoring.
[0120] It should be noted that this embodiment can be combined with any one of Embodiments 1 to 5, and the technical solutions of combining this embodiment with any one of Embodiments 1 to 5 are all covered by the protection scope of the present invention.
[0121] According to the second technical solution of the present invention, Fig.16 As shown, a delivery system 200 is provided, the delivery system 200 includes the coated stent 100 in the technical solution of the first aspect, the delivery system 200 also includes a delivery component for delivering the coated stent 100 to a preset position, the delivery component includes a delivery handle and a delivery sheath extending from the proximal end of the delivery handle, the delivery system 200 also includes a pre-buried guide wire 2002, the distal end of the pre-buried guide wire 2002 extends into the main lumen of the main stent 10 and then passes through the side lumen of the side branch 20, the coated stent 100 and the pre-buried guide wire 2002 passing through the coated stent 100 are assembled in the delivery sheath, the proximal end of the pre-buried guide wire 2002 extends from the delivery handle, and when the delivery sheath is withdrawn, the distal end of the pre-buried guide wire 2002 is configured to enter the preset branch.
[0122] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.
Claims
1. A stent graft, It is characterized in that The invention comprises a main stent and a side branch connected to the main stent, wherein the side branch comprises a first end and a second end opposite to each other along its axial length, and the side lumen of the side branch is connected to the main lumen of the main stent; the side branch comprises at least a long branch having a first axial length and / or a short branch having a second axial length, and the first axial length is greater than the second axial length; wherein, When the side branch includes the long branch, the first end of the long branch is connected to the tube wall of the main stent, the second end of the long branch extends outside the main lumen, and the long branch is used as a treatment branch; When the side branch includes the short branch, the first end of the short branch is connected to the tube wall of the main stent, the second end of the short branch extends in the main lumen and / or outside the main lumen, and the short branch is used to connect with the external treatment branch.
2. The stent graft according to claim 1, It is characterized in that When the side branch includes a short branch, the short branch at least includes an embedded short branch located in the main cavity, a first end of the embedded short branch is connected to the tube wall of the main support, and a second end of the embedded short branch extends in the main cavity of the main support.
3. The stent graft according to claim 2, It is characterized in that The second end of the embedded short branch extends toward the central axis of the main support or the distal end of the main support, and the angle between the axis of the embedded short branch and the central axis of the main support is less than or equal to 90°.
4. The stent graft according to claim 3, It is characterized in that The port at the second end of the embedded short branch is configured as an inclined port inclined relative to the central axis of the main support.
5. The stent graft according to claim 4, It is characterized in that Along the direction from the distal end of the main body support toward the proximal end, the distance between the inclined opening and the central axis of the main body support in the radial direction gradually decreases.
6. The stent graft according to claim 2, It is characterized in that A through hole for the guide wire to pass through is provided on the tube wall of the embedded short branch close to the proximal end of the main support.
7. The stent graft according to claim 2, It is characterized in that The short branch also includes an external short branch located outside the main lumen, a first end of the external short branch is connected to the tube wall of the main support, and a second end of the external short branch extends outside the main lumen of the main support.
8. The stent graft according to claim 7, It is characterized in that The external short branch is coaxially arranged with the internal short branch, and the side lumen of the coaxially arranged external short branch is communicated with the side lumen of the internal short branch.
9. The stent graft according to claim 1, It is characterized in that The short branch comprises an external short branch located outside the main lumen, a first end of the external short branch is connected to the tube wall of the main support, and a second end of the external short branch extends outside the main lumen of the main support.
10. The stent graft according to any one of claims 1 to 9, It is characterized in that When the side branch includes a short branch, the short branch is configured as an equal-diameter or non-equal-diameter setting along the axial direction of the short branch; wherein, when the short branch is configured as a non-equal-diameter setting, at least a portion of the short branch is in a reduced diameter shape along its own axial direction.
11. The stent graft according to claim 10, It is characterized in that The diameter of the first end of the short branch is smaller than the diameter of the second end, or, The diameter of the first end of the short branch is larger than the diameter of the second end thereof.
12. The stent graft according to any one of claims 1 to 9, It is characterized in that The long branch and / or the short branch include a plurality of wave coils arranged in sequence along their own axial length, and any of the wave coils include a plurality of wave structures connected end to end along the circumferential direction; wherein, at least the wave coils close to their respective first ends, the wave height in the proximal region and / or the distal region is smaller than the wave height in other regions of the same wave coil.
13. The stent graft according to claim 12, It is characterized in that At least the wave circle close to each first end is located in the proximal area or the distal area is a low wave, the area on the other side radially opposite is a high wave, and the other areas in the same wave circle are transition waves connecting the high wave and the low wave, and the waveform height of the transition wave gradually decreases from the high wave to the low wave.
14. The stent graft according to any one of claims 1 to 9, It is characterized in that The main body support comprises a first wave ring and a plurality of second wave rings, wherein the first wave ring is located at the distal end of the main body support relative to the second wave ring; The first end of the long branch and / or the short branch is connected to the tube wall of the main support between the first wave circle and the second wave circle adjacent to the first wave circle; and / or, The first end of the long branch and / or the short branch is connected to the tube wall of the main support between two adjacent second wave coils located at the farthest end side.
15. The stent graft according to any one of claims 1 to 9, It is characterized in that The second axial length of the short branch is in a range of 3 mm to 7 mm.
16. A conveying system, It is characterized in that It comprises a coated stent as described in any one of claims 1 to 15 and a delivery assembly for delivering the coated stent to a preset position, the delivery assembly comprising a delivery handle and a delivery sheath extending from the proximal end of the delivery handle, the delivery system further comprising a pre-buried guide wire, the distal end of the pre-buried guide wire extends into the main lumen of the main stent and then passes through the side lumen of the side branch, the coated stent and the pre-buried guide wire passing through the coated stent are assembled in the delivery sheath, the proximal end of the pre-buried guide wire extends from the delivery handle, and when the delivery sheath is withdrawn, the distal end of the pre-buried guide wire is configured to enter a preset branch.