Stent graft and stent graft delivery system

Abstract

The present invention discloses a coated stent and a coated stent delivery system. The coated stent of the present application includes a stent body and a guide wire, the stent body includes a main branch and a first branch and a second branch provided at the same end of the main branch, the main branch has a main lumen, the first branch and the second branch respectively have a first branch lumen and a second branch lumen, the first branch lumen and the second branch lumen are both connected to the main lumen, the connected first branch lumen, the main lumen and the second branch lumen form a preset passage, part of the guide wire is pre-placed in the preset passage, and the guide wire can move along the preset passage relative to the stent body under the action of an external force. The coated stent and the coated stent delivery system of the present invention can quickly establish a guide wire access route for extending the stent delivery device, while solving the problem of the guide wire coming out prematurely or being unable to be smoothly advanced, greatly reducing the operation time, and avoiding related complications due to excessively long operation time.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a stent graft and a stent graft delivery system. Background Art

[0002] Abdominal aortic aneurysm (ABA) is a common vascular disease that is difficult to treat and carries high surgical risks. In recent years, with advances in endovascular technology and materials, an increasing number of physicians and patients are choosing endovascular repair for ABA, with satisfactory follow-up results.

[0003] The stent devices currently on the market for treating abdominal aortic aneurysms are basically split structures, including a main bifurcated stent in the shape of a "human" and an extension stent, wherein the main bifurcated stent has a long iliac branch and a short iliac branch. When released, the main bifurcated stent is first released through the femoral artery on the side of the long iliac branch, and the short iliac branch is released into the aneurysm cavity of the abdominal aortic aneurysm, and then the short iliac branch is extended through the contralateral femoral artery. During the extension process, a guide wire must first be inserted from the contralateral femoral artery, and the guide wire is selected into the short iliac branch by controlling the guide wire, which serves as the guide wire entry route for the contralateral iliac artery extension stent delivery device, such as Figure 1 As shown in the figure, abdominal aortic aneurysms are usually large, and the short iliac branch is usually only a dozen millimeters in diameter. This, coupled with the downward impact of blood flow, makes it more difficult to insert the guidewire a into the short iliac branch b. During surgery, the surgeon often needs to spend a considerable amount of time to complete the guidewire insertion, significantly prolonging the operation and increasing the risk of complications for the patient. Summary of the Invention

[0004] Based on this, the present invention proposes a covered stent and a covered stent delivery system, which aim to reduce the difficulty of selecting a guide wire into the short branch of a bifurcated stent, shorten the operation time, and reduce complications.

[0005] To achieve this object, the present invention adopts the following technical solutions:

[0006] A coated stent comprises a stent body and a guide wire, the stent body comprising a main branch and a first branch and a second branch arranged at the same end of the main branch, the main branch having a main lumen, the first branch and the second branch respectively having a first branch lumen and a second branch lumen, the first branch lumen and the second branch lumen being both connected to the main lumen, the connected first branch lumen, the main lumen and the second branch lumen forming a preset passage, part of the guide wire being pre-placed in the preset passage, and the guide wire being movable relative to the stent body along the preset passage under the action of external force.

[0007] In one embodiment, the stent graft further includes a limiting structure provided on the preset pathway, and the limiting structure is capable of constraining a guide wire pre-placed in the preset pathway.

[0008] In one embodiment, the limiting structure includes a limiting component provided in the bracket body, the limiting component is relatively fixed to the bracket body, and a limiting channel for the guide wire to pass through is provided on the limiting component and / or between the limiting component and the bracket body.

[0009] In one embodiment, the limiting assembly includes a tubular limiting member having a lumen fixed to the stent body, and the lumen forms the limiting channel;

[0010] and / or comprising a sheet-shaped limiting member partially fixed to the bracket body, wherein a gap between the sheet-shaped limiting member and a non-fixed portion of the bracket body forms the limiting channel;

[0011] And / or, it includes an annular limiting member having a through hole fixedly connected to the bracket body, and the through hole forms the limiting channel.

[0012] In one embodiment, the first branch lumen has a first proximal wall close to the central axis of the main branch and a first distal wall away from the central axis of the main branch;

[0013] The second branch lumen has a second proximal wall close to the central axis of the main branch and a second distal wall away from the central axis of the main branch;

[0014] The limiting assembly is fixedly mounted on at least the first proximal side wall and the second proximal side wall;

[0015] Or; the limiting assembly is fixed on at least the first distal wall and the second proximal wall;

[0016] Or; the limiting assembly is fixed on at least the first proximal wall and the second distal wall;

[0017] Or; the limiting component is fixed on at least the first distal wall and the second distal wall.

[0018] In one embodiment, an anti-slip structure is provided on the outer peripheral surface of the guide wire pre-placed in the preset passage, and the anti-slip structure cooperates with the limiting structure to prevent the guide wire from detaching from the bracket body when not subjected to external force.

[0019] In one embodiment, the anti-slip structure includes a groove formed on the outer peripheral surface of the guide wire; and / or a rough portion formed on the outer peripheral surface of the guide wire.

[0020] In one embodiment, when the anti-slip structure includes a groove, the groove is a wedge-shaped groove, the convergent end of the wedge-shaped groove points to the proximal end of the guide wire, and the wedge-shaped groove cooperates with the limiting assembly so that the guide wire can only move toward the distal end under the action of external force.

[0021] In one embodiment, the distal end of the guide wire is provided with an anti-detachment block, and the outer diameter of the anti-detachment block is larger than the inner diameter of the limiting channel, so that the guide wire can only detach from the stent body in one direction.

[0022] On the other hand, the present invention adopts the following technical solutions:

[0023] A stent graft delivery system includes a conveyor and the above-mentioned stent graft, wherein the conveyor is used to deliver the stent graft, the conveyor includes a sheath core and a sheath tube, and the stent graft is placed between the sheath core and the sheath tube.

[0024] The coated stent and coated stent delivery system of the present invention provide a main lumen in the main branch, and provide a first branch lumen and a second branch lumen in the first branch and the second branch respectively, and make the first branch lumen and the second branch lumen connected to the main lumen to form a preset passage that penetrates the outside world. Part of the guide wire is placed in the preset passage, and can move relative to the stent body along the preset passage in the stent body under the action of external force, so as to quickly establish a guide wire entry for extending the stent delivery device, and at the same time solve the problem of premature dislocation of the guide wire or inability to advance smoothly, greatly reducing the operation time, and avoiding related complications due to excessively long operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a schematic diagram of the structure of the branch-release stent graft in the prior art;

[0026] Figure 2 is a schematic structural diagram of an exemplary stent graft of the present invention;

[0027] Figure 3 A schematic structural diagram and a partially enlarged view of a stent graft according to an embodiment of the present invention;

[0028] Figure 4 for Figure 3 Schematic diagram of the top view of the stent graft;

[0029] Figure 5 This is a structural schematic diagram and a partial enlarged view of a stent graft according to another embodiment of the present invention;

[0030] Figure 6 for Figure 5 A schematic top view and a partial enlarged view of the stent graft;

[0031] Figure 7 This is a structural schematic diagram and a partial enlarged view of a stent graft according to another embodiment of the present invention;

[0032] Figure 8 for Figure 7 Schematic diagram of the top view of the stent graft;

[0033] Figure 9 Schematic diagram of the partial structure of a guide wire according to one embodiment of the present invention;

[0034] Figure 10 for Figure 9 A schematic diagram of the structure of the cooperation between the guide wire and the limiting structure;

[0035] Figure 11 This is a schematic diagram of the partial structure of a guidewire according to another embodiment of the present invention;

[0036] Figure 12 for Figure 11 A schematic diagram of the structure of the relative coordination between the guide wire and the limiting structure;

[0037] Figure 13 Schematic diagram of the guidewire in the present invention passing through a preset pathway from the first branch lumen into the second branch lumen;

[0038] Figure 14 Schematic diagram of the guidewire entering the contralateral common iliac artery in the present invention;

[0039] Figure 15 Schematic diagram of the guidewire and the capture device cooperating to establish a contralateral guidewire approach in the present invention;

[0040] Figure 16 Schematic diagram of the stent graft delivery system of the present invention when the contralateral guidewire access is completed.

[0041] The symbols in the accompanying drawings represent the following:

[0042] 100: stent graft;

[0043] 10: stent body, 11: main branch, 11a: main lumen, 12: first branch, 12a: first branch lumen, 13: second branch, 13a: second branch lumen;

[0044] 20: guide wire, 20a: smooth section, 20b: anti-slip section, 20b1: groove, 20b2: rough part, 20c: anti-slip block;

[0045] 30a: tubular limiting member, 30a1: first channel, 30b: sheet limiting member, 30b1: second channel, 30c: annular limiting member, 30c1: third channel;

[0046] 200: Catcher. DETAILED DESCRIPTION

[0047] In order to make the objectives, technical solutions, and advantages of the present invention more clearly understood, exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although 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 described 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.

[0048] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain" and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the specific order described or illustrated, unless the order of execution is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0049] 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 otherwise, 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 example embodiments.

[0050] For ease of description, spatially 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 figures, such as "inside," "outside," "inside," "outside," "below," "beneath," "above," and the like. Such spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "below" another element or feature would then be oriented as "above" or "above" another element or feature. Thus, the example term "below" can include both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein are interpreted accordingly.

[0051] Additionally, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or the delivery system that delivers the medical device, that is closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." This principle is used to define the "proximal end" and "distal end" of any component of a medical device or delivery system. "Axial" generally refers to the length of the medical device during delivery, and "radial" generally refers to the direction perpendicular to the "axial" direction of the medical device. This principle is used to define the "axial" and "radial" directions of any component of a medical device.

[0052] See Figure 2 As shown, the present invention exemplarily provides a coated stent 100, which includes a stent body 10 and a guide wire 20. The stent body 10 and the guide wire 20 each include a distal end and a proximal end. A preset passage S is formed in the stent body 10, wherein the preset passage S is connected to the outside, where the outside refers to the outside of the stent body 10. The distal end of the guide wire 20 enters the stent body 10 along the preset passage S and a portion of the guide wire 20 is pre-placed in the stent body 10, while the proximal end of the guide wire 20 is placed outside the stent body 20. The guide wire 20 can move relative to the stent body 10 along the preset passage S in the stent body 10 under the action of an external force. The coated stent 100 of the present invention, which includes a stent body 10 and a guide wire 20, is loaded in a conveyor. During use, after the coated stent 100 is released, external force can be applied to the guide wire 20, so that the guide wire 20 moves along the preset path S, thereby quickly establishing a guide wire entry path for extending the stent conveyor, reducing the difficulty of the guide wire 20 selecting the short branch of the bifurcated stent, shortening the operation time, and reducing complications.

[0053] The methods of applying external force to the guidewire 20 to move the guidewire 20 along the preset path S include, but are not limited to, pushing the guidewire 20 from the proximal end of the guidewire 20 to move the guidewire 20 along the preset path S. Alternatively, the distal end of the guidewire 20 may be captured by a catcher, and then the catcher may be pulled to move the guidewire 20 along the preset path S. Alternatively, the movement of the guidewire 20 may be achieved by combining the proximal pushing of the guidewire 20 and the capture and pulling of the distal end by a catcher. It should be understood that the above-mentioned methods of applying external force are merely exemplary and are not intended to be limiting.

[0054] It should be noted that the distal end of the guidewire 20 enters the stent body 10 along the preset path S and is partially placed in the stent body 10, including two situations: the distal end of the guidewire 20 enters the stent body 10 along the preset path and its distal end passes through the stent body 10, and the distal end of the guidewire 20 enters the stent body 10 along the preset path but its distal end does not pass through the stent body 10. The distal end of the guidewire 20 passes through the stent body 10, that is, the distal end of the guidewire 20 extends out of the stent body 10, at which time the portion between the distal end and the proximal end of the guidewire 20 is placed in the stent body 10. The distal end of the guidewire 20 does not pass through the stent body 10, that is, the distal end of the guidewire 20 does not extend out of the stent body 10, at which time the distal end of the guidewire 20 and the portion of the guidewire near the distal end are placed in the stent body 10.

[0055] like Figure 2 As shown, the stent body 10 includes a main branch 11 and a first branch 12 and a second branch 13. The main branch 11, the first branch 12 and the second branch 13 each include a distal end and a proximal end. The distal end of the first branch 12 and the distal end of the second branch 13 are simultaneously connected to the proximal end of the main branch 11. The main branch 11 has a main lumen 11a, the first branch 12 has a first branch lumen 12a, and the second branch 13 has a second branch lumen 13a. The first branch lumen 12a and the second branch lumen 13a are both connected to the main lumen 11a. For example, taking the abdominal aorta bifurcation stent as an example, the stent body 10 is a three-way structure in the shape of a "human", which includes a main branch at the proximal end and a pair of iliac branches at the distal end. The pair of iliac branches includes a right iliac branch suitable for the right iliac artery or the abdominal aorta and a left iliac branch suitable for the left iliac artery. The right iliac branch is longer than the left iliac branch, and the distal ends of the left and right iliac branches form a main bifurcation at the proximal end of the main branch. It is understandable that the structure of the bracket body 10 of this embodiment is not limited to this, and can be further expanded on this basis.

[0056] It is understandable that the proximal ends of the first branch 12 and the second branch 13 are respectively formed with a first proximal tube opening of the first branch lumen 12a and a second proximal tube opening of the second branch lumen 13a. The guide wire 20 passes through the first proximal tube opening or the second proximal tube opening and enters the stent body 10 along the preset path S and is partially placed in the stent body 10, and it can move along the preset path S under the action of an external force. Among them, the movement of the guide wire 20 along the preset path S under the action of an external force includes forward movement and reverse movement. The forward movement refers to the movement of penetrating from the first proximal tube opening, and passing through the first branch lumen 12a, the main lumen 11a, and the second branch lumen 13a in sequence, and then passing out from the second proximal tube opening. The reverse movement refers to the movement of penetrating from the second proximal tube opening, and passing through the second branch lumen 13a, the main lumen 11a, and the first branch lumen 12a in sequence, and then passing out from the first proximal tube opening. Preferably, the movement of this embodiment refers to forward movement.

[0057] Because the guidewire is small and has a certain hardness, and the diameter of the preset passage formed by the lumen changes greatly before and after compression, the position of the prefabricated guidewire placed in the preset passage will change continuously due to this change. This change is often unpredictable and uncontrollable, often causing the distal end of the prefabricated guidewire to slip off the shorter branch or making it difficult to push the guidewire. In view of this, refer to Figure 3 As shown, the coated stent also includes a limiting structure provided on a preset passage, which can constrain the guide wire pre-placed in the preset passage. The position of the constrained prefabricated guide wire will not change with the compression of the lumen, and the limiting structure will have a certain guiding function during the pushing process, which facilitates the smooth delivery of the prefabricated guide wire. Preferably, the limiting structure is at a preset distance from the distal end of the second branch lumen of the second branch. The preset distance allows the prefabricated guide wire to have radial movement space near the tube mouth of the second branch lumen, which ensures that the guide catheter can smoothly enter the second branch lumen after passing through the prefabricated guide wire, thereby completing the implantation of the extended stent.

[0058] As an embodiment of the limiting structure, the limiting structure includes a limiting component provided in the stent body 10, the limiting component and the stent body 10 are relatively fixed, and a limiting channel for the guide wire 20 to pass through is provided on the limiting component and / or between the limiting component and the stent body 10. Among them, the limiting component can be relatively fixed to the stent body 10 by a PTFE heat treatment method or a PET suturing method. It should be noted that the fixing method is not limited to this, and it is only an exemplary description. In other embodiments, the limiting structure can be formed by the wave ring of the stent body. For example, the prefabricated guide wire can be inserted between the inner coating and the wave ring, and the inner coating and the wave ring press and constrain the prefabricated guide wire. It is also possible that the radial side of the wave ring extends out of the inner coating at intervals to form a constraint portion for the prefabricated guide wire to pass through. Of course, the constraint method defined by the limiting structure is not limited to this.

[0059] As an implementation of the limit assembly, see Figure 3 and Figure 4 As shown, the limiting assembly includes a tubular limiting member 30a having a through-hole cavity connected to the lumen wall of the stent body 10. The lumen inside the tubular limiting member 30a forms a first limiting channel 30a1 for passing the guide wire 20. Exemplarily, the tubular limiting member 30a can be fixed to the lumen wall of the stent body 10 by PTFE heat treatment or PET suturing.

[0060] Specifically, the first branch lumen 12a has a first proximal wall close to the central axis of the main branch 11 and a first distal wall away from the central axis of the main branch 11. The second branch lumen 13a has a second proximal wall close to the central axis of the main branch 11 and a second distal wall away from the central axis of the main branch 11.

[0061] Continue reading Figure 3 and Figure 4 As shown, as a setting method of the tubular limiter 30a, a tubular limiter 30a is respectively fixed on the first proximal wall of the first branch lumen 12a and the second proximal wall of the second branch lumen 13a. Specifically, the tubular limiter 30a can be connected to the first proximal wall and the second proximal wall by PTFE heat treatment or PET suturing. The tubular limiter 30a extends along the axial direction of the stent body 10, and the tubular limiter 30a in the first branch lumen 12a is substantially the same length as the first branch 12, and the two ends of the tubular limiter 30a in the first branch lumen 12a are respectively connected to the proximal end and distal end of the first branch lumen 12a. The length of the tubular limiter 30a in the second branch lumen 13a is slightly smaller than the length of the second branch 13. The upper end of the tubular limiter 30a in the second branch lumen 13a is connected to the proximal end of the second branch lumen 13a, and the lower end of the tubular limiter 30a in the second branch lumen 13a is connected to the second proximal wall of the second branch 13. The lower end of the tubular limiter 30a is at a certain distance from the distal end of the second bracket, so that the entry of the guide wire 20 in the first branch lumen 12a and the second branch lumen 13a is effectively constrained and limited through the first limiting channel 30a1 in the tubular limiter 30a. The guide wire 20 is inserted from the proximal end of the first branch lumen 12a into the first limiting channel of the tubular limiting member 30a of the first branch lumen 12a, then extends into the main lumen through the distal end of the first branch lumen 12a, bends and then enters the first limiting channel of the tubular limiting member 30a of the second branch lumen 13a through the distal end of the second branch lumen 13a, and finally extends to the outside of the stent body 10 through the proximal end of the second branch lumen 13a. The tubular limiting member 30a not only constrains the guide wire 20 circumferentially, but also establishes a narrow moving channel in the preset passage, avoiding the guide wire from moving and slipping randomly in the preset passage, and ensuring the smooth advancement of the preset guide wire 20, which is conducive to quickly establishing a guide wire entry route for extending the stent conveyor, reducing the difficulty of selecting the guide wire 20 into the short branch of the bifurcated stent, shortening the operation time, and reducing complications.

[0062] In other embodiments of the present application, a tubular limiter 30a is fixedly provided on the first distal wall of the first branch lumen 12a and the second proximal wall of the second branch lumen 13a, respectively; or a tubular limiter 30a is fixedly provided on the first proximal wall of the first branch lumen 12a and the second distal wall of the second branch lumen 13a, respectively; or a tubular limiter 30a is fixedly provided on the first distal wall of the first branch lumen 12a and the second distal wall of the second branch lumen 13a, respectively. The above multiple settings can effectively limit the entry path of the guide wire 20. Of course, the specific settings can be made according to actual needs and are not limited to the above.

[0063] Preferably, the inner diameter of the first limiting channel 30a1 of the tubular limiting member 30a is larger than the outer diameter of the guide wire 20, and is less than or equal to 2 times the outer diameter of the guide wire 20, so as to avoid the guide wire 20 being bent and stacked during the advancement process after the coated stent 100 is implanted due to the diameter of the first limiting channel 30a1 of the tubular limiting member 30a being too small or too large, thereby making it difficult or impossible to advance the guide wire 20.

[0064] In other embodiments, the tubular limiter 30a can be connected to the tubular wall of the bracket body 10 at intervals. The structure of the tubular limiter 30a can refer to the above. The difference is that the axial length of the tubular limiter 30a in this embodiment is shorter than that in the above embodiment. Therefore, multiple shorter tubular limiters 30a can be arranged at intervals.

[0065] Recombination Figure 3 and Figure 4 As shown, the radius size R0 of the curved part of the guide wire 20 provided in the main cavity 11a is ≥ 2mm, which can avoid the large resistance to pushing the subsequent guide wire 20 due to the small bending radius of the guide wire 20, which makes pushing difficult, and avoids the displacement of the coated stent 100 and the failure of the operation. At the same time, the distance L0 between the apex of the curved part of the guide wire 20 provided in the main cavity 11a and the bifurcation of the stent body 10 should be greater than or equal to the diameter of the guide wire 20, and less than or equal to the coating height L1 of the main branch 11, so as to avoid the guide wire 20 occupying the compression space of the coating of the main branch 11 due to the setting position of the guide wire 20 in the main cavity 11a being too high, resulting in difficulty in assembling and releasing the coated stent 100. It should be noted that the number and arrangement of the tubular limiters 30a of this embodiment are only exemplary and are not limited thereto, and can be selected according to actual conditions. In addition, the arrangement of the guide wire 20 in the preset passage is not limited to the first distal wall of the first branch lumen 12a and the second proximal wall of the second branch lumen 13a shown in this embodiment, and can be specifically arranged according to actual needs.

[0066] As another embodiment of the limit assembly, see Figure 5 and Figure 6As shown, the limiting assembly includes a sheet-shaped limiting member 30b partially fixed to the lumen wall of the stent body 10. The gap between the sheet-shaped limiting member 30b and the non-fixed portion of the lumen wall of the stent body 10 forms a second limiting channel 30b1 for passing the guidewire 20. Exemplarily, the sheet-shaped limiting member 30b can be fixed to the lumen wall of the stent body 10 by PTFE heat treatment or PET suturing.

[0067] Specifically, see Figure 5 and Figure 6 As shown, as one arrangement of the sheet-like stopper 30b, a sheet-like stopper 30b is fixedly provided on the first distal wall of the first branch lumen 12a and the second proximal wall of the second branch lumen 13a. Only two sides of the sheet-like stopper 30b are fixedly connected to the lumen walls, and a second limiting channel 30b1 is formed between the sheet-like stopper 30b and the lumen wall at the center of the sheet-like stopper 30b where it is not fixed to the lumen wall. Simultaneously, at least one sheet-like stopper 30b is also provided within the main lumen 11a. A second limiting channel 30b1 is also formed between the sheet-like stopper 30b provided within the main lumen 11a and the lumen wall of the main lumen 11a. The curved portion of the guidewire 20 provided within the main lumen 11a passes through the sheet-like stopper 30b and forms the second limiting channel 30b1 between the lumen wall of the main lumen 11a. For example, the sheet-shaped limiting member 30b can be fixed to the lumen wall of the stent body 10 by PTFE heat treatment or PET suturing.

[0068] By connecting the sheet-like limiting member 30b to the first distal wall of the branch lumen 12a and the second proximal wall of the second branch lumen 13a, respectively, the path of the guide wire 20 in the main lumen 11a can be further extended and the bending radius of the guide wire 20 in the main lumen 11a can be increased, thereby reducing the requirements for the bending performance of the guide wire 20. At the same time, the pushing performance of the guide wire 20 after the implantation of the coated stent 100 can be improved and the pushing resistance can be reduced. At the same time, the sheet-like limiting member 30b is used to limit the guide wire entry paths in the first branch lumen 12a, the second branch lumen 13a and the main lumen 11a, which is conducive to compressing the coated stent 100 to a smaller diameter size and reducing the difficulty of assembling the coated stent 100. In addition, the sheet-like limiting member 30b distributed in the main cavity 11a is provided at the apex position of the curved portion of the guide wire 20, thereby preventing the guide wire 20 from being smoothly pushed from the second limiting channel 30b1 in the second branch cavity 13a to the outside of the stent body 10 due to uneven force during the pushing process after the stent graft 100 is implanted. It should be noted that the number and arrangement of the sheet-like limiting members 30b of this embodiment are only exemplary and are not limited thereto, and can be specifically selected according to actual conditions. In addition, the arrangement of the guide wire 20 in the preset passage is not limited to the first distal wall of the first branch cavity 12a and the second proximal wall of the second branch cavity 13a shown in this embodiment, and can be specifically arranged according to actual needs.

[0069] As another embodiment of the limit assembly, see Figure 7 and Figure 8 As shown, the limiting assembly includes an annular limiting member 30c having a through hole connected to the lumen wall of the stent body 10, and the through hole forms a third limiting channel 30c1 for the guide wire 20 to pass through.

[0070] Specifically, see Figure 7 and Figure 8 As shown, as a setting method of the annular limiter 30c, a plurality of annular limiters 30c are respectively connected to the first distal wall of the first branch lumen 12a and the second proximal wall of the second branch lumen 13a. The plurality of annular limiters 30c are arranged at intervals from each other, and together form a third limiting channel 30c1 for the guide wire 20 to pass through the annular through holes of the plurality of annular limiters 30c. At the same time, at least one annular limiter 30c is also provided in the main lumen 11a, and the annular limiter 30c provided in the main lumen 11a is connected to the lumen wall of the main lumen 11a. Specifically, the annular limiter 30c can be connected to the lumen wall of the stent body 10 by PTFE heat treatment or PET suturing. The curved portion of the guide wire 20 provided in the main lumen 11a passes through the third limiting channel 30c1 of the annular limiter 30c. The annular stopper 30c also constrains the guidewire circumferentially, enabling rapid establishment of a guidewire route for extending the stent delivery device, reducing the difficulty of inserting the guidewire 20 into the short branch of the bifurcated stent, shortening the surgical time, and reducing complications. It should be noted that the number and arrangement of the annular stoppers 30c of this embodiment are merely exemplary and are not limited thereto, and can be specifically selected based on actual circumstances. In addition, the arrangement of the guidewire 20 within the preset pathway is not limited to the first distal wall of the first branch lumen 12a and the second proximal wall of the second branch lumen 13a shown in this embodiment, and can be specifically arranged based on actual needs.

[0071] It should also be noted that the tubular stopper, sheet stopper, and annular stopper shown above can be used individually or in combination. For example, in one embodiment, the stopper assembly includes both the tubular stopper 30a and the sheet stopper 30b. In another embodiment, the stopper assembly includes both the tubular stopper 30a, the sheet stopper 30b, and the annular stopper 30c. Alternatively, in another embodiment, the stopper assembly includes both the sheet stopper 30b and the annular stopper 30c. Alternatively, in other embodiments, the stopper assembly includes both the tubular stopper 30a and the annular stopper 30c. The specific selection can be made according to needs.

[0072] Furthermore, in order to prevent the pre-placed guide wire 20 from falling off prematurely during the manufacturing, assembly and release of the abdominal aorta bifurcation stent 10, thereby affecting the subsequent operation of the surgery or causing the failure of the surgery, refer to Figures 9 to 12 As shown, as an example, an anti-slip structure is preferably provided on the guide wire 20. The anti-slip structure cooperates with the limiting structure to prevent the guide wire from escaping from the stent body when not subjected to external force. The anti-slip structure enhances the connection strength between the guide wire 20 and the limiting structure, preventing the guide wire 20 from escaping from the stent body 10 when not subjected to external force. Exemplarily, the anti-slip structure includes a groove 20b1 provided on the outer circumference of the guide wire 20; and / or a rough portion 20b2 provided on the outer circumference of the guide wire 20.

[0073] For example, see Figures 9 to 12 As shown, the guide wire 20 includes a smooth section 20a and an anti-slip section 20b prefabricated in the stent body, and the anti-slip structure is formed on the anti-slip section 20b. In other embodiments, the groove 20b1 and the rough portion 20b2 can be provided separately or in combination, and the specific arrangement can be selected according to actual needs.

[0074] Furthermore, as mentioned above, the movement direction of the guide wire 20 includes forward movement and reverse movement, wherein the forward movement is the movement from the first branch lumen 12a, through the main lumen 11a and to the second branch lumen 13a, that is, Figure 1 The direction indicated by the black tip is the positive direction of the preset path S. The reverse movement is the movement from the second branch lumen 13a, through the main lumen 11a and to the first branch lumen 12a, that is, Figure 1 The direction opposite to the direction indicated by the black tip is the opposite direction of the preset path S. In the process of use, in order to prevent the guide wire from moving in the reverse direction and escaping from the stent body 10, refer to Figure 9 and Figure 10 As shown, when the anti-slip structure includes a groove 20b1, the groove 20b1 is a wedge-shaped groove, with the converging end of the wedge-shaped groove pointing toward the proximal end of the guidewire. The wedge-shaped groove cooperates with the limiting structure to ensure that the guidewire can only move toward the distal end under the action of an external force, that is, it can only move in the forward direction. In other words, the guidewire can only move forward and not backward. This method not only prevents the guidewire from falling off prematurely, but also ensures that the guidewire can only move toward the distal end under the action of an external force, effectively preventing the doctor from withdrawing the pre-placed guidewire from the long branch due to misoperation. The maximum radial dimension of the wedge-shaped groove on the anti-slip segment 20b is equal to the diameter of the smooth segment 20a.

[0075] like Figure 10 As shown, the wedge-shaped groove cooperates with the third limiting channel 30c1 of the annular limiting member 30c, thereby enhancing the connection strength between the guide wire 20 and the annular limiting member 30c, preventing the guide wire 20 from falling off prematurely during the manufacturing, assembly and release process of the coated stent 100, affecting the subsequent operation of the operation or causing the failure of the operation.

[0076] Specifically, see Figure 10As shown, the wedge-shaped groove provided on the anti-slip section 20b of the guide wire 20 has a length dimension b0 along the axial direction of the guide wire 20, and the length dimension b1 of the annular limiter 30c along its own axial direction, wherein b1≤b0≤2b1, thereby avoiding the situation where the length dimension of the wedge-shaped groove on the anti-slip section 20b is set too small, resulting in the annular limiter 30c being unable to cooperate with the wedge-shaped groove, causing the anti-slip effect of the anti-slip section 20b of the guide wire 20 to fail; or because the length dimension of the wedge-shaped groove on the anti-slip section 20b is set too large, after the annular limiter 30c cooperates with the anti-slip section 20b, the guide wire 20 can still slide along the annular limiter 30c, thereby resulting in a reduction in the anti-slip effect, thereby reducing the risk of the guide wire 20 falling off prematurely during the production, assembly and release of the coated bracket 100. In addition, the convergent end of the wedge-shaped groove points to the proximal end of the guide wire 20, that is, the large diameter section of the wedge-shaped groove points to the proximal end of the guide wire 20. During use, the convergent end of the wedge-shaped groove can hook the annular limiter 30c, and the small diameter section of the wedge-shaped groove will not affect the normal advancement of the guide wire 20 along the preset path S, ensuring that the guide wire 20 can only advance in one direction along the positive direction of the preset path S, avoiding the guide wire 20 being pulled out in the opposite direction due to misoperation or other reasons.

[0077] See Figure 11 and Figure 12 As shown, the rough portion 20b2 cooperates with the third limiting channel 30c1 of the annular limiting member 30c, thereby strengthening the connection strength between the guidewire 20 and the annular limiting member 30c, preventing the guidewire 20 from prematurely falling off during the manufacturing, assembly, and release of the stent graft 100, which could affect subsequent surgical procedures or lead to surgical failure. The rough portion 20b2 can be obtained using a variety of processes, and the specific process is not limited thereto. The diameter of the rough portion 20b2 is equal to the diameter of the smooth segment 20a.

[0078] Further, see Figure 12 As shown, in other embodiments, the distal end of the guidewire 20 is further provided with an anti-slip block 20c, and the outer diameter of the anti-slip block 20c is larger than the inner diameter of the limiting channel, so that the guidewire 20 can only detach from the stent body in one direction. As an embodiment, the anti-slip block 20c is a partially spherical structure with a spherical surface pointing to the distal end, the maximum diameter of the anti-slip block 20c is D0, and the diameter of the third limiting channel 30c1 of the annular limiting member 30c is D1, wherein D0>D1, thereby ensuring that the guidewire 20 can only advance in one direction along the positive direction of the preset path S, avoiding the guidewire 20 from being pulled out in the opposite direction due to misoperation and other reasons, and reducing the risk of failure in establishing the guidewire access to the coated stent 100.

[0079] It should be further explained that the anti-slip section 20b of the guide wire 20 is Figure 7 and Figure 8In addition to the annular limiting member 30c shown in the figure, it can also be matched with other forms of limiting components in the present invention, such as the anti-slip section and Figure 3 and Figure 4 The tubular limiting member 30a in the middle cooperates with the anti-slip section 30a, or the anti-slip section 30a Figure 5 and Figure 6 The sheet-like limiting member 30b in the anti-slip section 20b can effectively ensure that the guide wire 20 can only move forward in one direction along the positive direction of the preset path S under the action of external force, thereby preventing the guide wire 20 from being withdrawn in the opposite direction due to misoperation and other reasons, and reducing the risk of failure in establishing the guide wire access path for the coated stent 100. It should be noted that when the groove on the anti-slip section 20b cooperates with the tubular limiting member 30a, a groove structure can be provided only at the distal end of the guide wire so that it can be hooked with the end of the tubular limiting member 30a. The guide wire 20 of the above embodiment can also be used in other stent structures.

[0080] Take the abdominal aorta bifurcation stent as an example to illustrate, combined with Figures 13 to 16 As shown, the guidewire 20 in the coated stent 100 is pre-placed in the stent body 10, and the specific release process is as follows: first release the main branch 11 and the second branch 13, and then push the pre-placed guidewire 20 forward along the preset path S until the pre-placed guidewire 20 is pushed out of the stent body 10 and enters the contralateral common iliac artery, or after the guidewire 20 is pushed out of the second branch 13, it enters the capturer 200 from the contralateral femoral artery, and is captured and pulled out of the contralateral femoral artery incision by the capturer 200, thereby completing the establishment of the guidewire access for the contralateral iliac artery extension stent.

[0081] Another aspect of the present invention further provides a stent graft delivery system, comprising a conveyor and a stent graft 100 according to any of the aforementioned embodiments. The conveyor is used to deliver the stent graft 100, and comprises a sheath core and a sheath tube, with the stent graft 100 positioned between the sheath core and the sheath tube. Because the stent graft delivery system is provided with the stent graft 100 according to any of the aforementioned embodiments, it also has the beneficial effects of the stent graft 100 according to any of the aforementioned embodiments, which will not be further elaborated here.

[0082] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned 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.

[0083] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A stent graft, characterized in that: The invention comprises a stent body and a guide wire, wherein the stent body comprises a main branch and a first branch and a second branch arranged at the same end of the main branch, the main branch has a main lumen, the first branch and the second branch respectively have a first branch lumen and a second branch lumen, the first branch lumen and the second branch lumen are both connected to the main lumen, and the connected first branch lumen, the main lumen and the second branch lumen form a preset passage, part of the guide wire is pre-placed in the preset passage, and the guide wire can move along the preset passage relative to the stent body under the action of external force; the coated stent also comprises a limiting structure arranged on the preset passage, and the limiting structure can restrain the guide wire pre-placed in the preset passage; an anti-slip structure is provided on the outer peripheral surface of the guide wire pre-placed in the preset passage, and the anti-slip structure cooperates with the limiting structure to prevent the guide wire from detaching from the stent body when not subject to external force.

2. The stent graft according to claim 1, wherein: The limiting structure includes a limiting component provided in the bracket body, the limiting component and the bracket body are relatively fixed, and a limiting channel for the guide wire to pass through is provided on the limiting component and / or between the limiting component and the bracket body.

3. The stent graft according to claim 2, wherein: The limiting assembly includes a tubular limiting member having a lumen fixed to the stent body, wherein the lumen forms the limiting channel; and / or comprising a sheet-shaped limiting member partially fixed to the bracket body, wherein a gap between the sheet-shaped limiting member and a non-fixed portion of the bracket body forms the limiting channel; And / or, it includes an annular limiting member having a through hole fixedly connected to the bracket body, and the through hole forms the limiting channel.

4. The stent graft according to claim 3, wherein: The first branch lumen has a first proximal wall close to the central axis of the main branch and a first distal wall away from the central axis of the main branch; The second branch lumen has a second proximal wall close to the central axis of the main branch and a second distal wall away from the central axis of the main branch; The limiting assembly is fixedly mounted on at least the first proximal side wall and the second proximal side wall; Or; the limiting assembly is fixed on at least the first distal wall and the second proximal wall; Or; the limiting assembly is fixed on at least the first proximal wall and the second distal wall; Or; the limiting component is fixed on at least the first distal wall and the second distal wall.

5. The stent graft according to any one of claims 1 to 4, characterized in that: The anti-slip structure includes a groove formed on the outer peripheral surface of the guide wire; and / or a rough portion formed on the outer peripheral surface of the guide wire.

6. The stent graft according to claim 5, characterized in that: When the anti-slip structure includes a groove, the groove is a wedge-shaped groove, the convergent end of the wedge-shaped groove points to the proximal end of the guide wire, and the wedge-shaped groove cooperates with the limiting assembly so that the guide wire can only move toward the distal end under the action of external force.

7. The stent graft according to any one of claims 1 to 4, characterized in that: The distal end of the guide wire is provided with an anti-detachment block, the outer diameter of the anti-detachment block is larger than the inner diameter of the limiting channel, so that the guide wire can only detach from the bracket body in one direction.

8. A stent graft delivery system, characterized in that: It comprises a conveyor and a coated stent as described in any one of claims 1 to 7, wherein the conveyor is used to convey the coated stent, the conveyor comprises a sheath core and a sheath tube, and the coated stent is placed between the sheath core and the sheath tube.

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