Aortic endovascular structure and blood flow whole-course remodeling device

Abstract

The present disclosure relates to the technical field of medical instruments. Provided is an aortic endovascular structure and blood flow whole-course remodeling device, comprising a sealing portion and a main body. When the sealing portion is arranged in a first tube portion of the main body, the sealing portion arranged on the inner wall of the first tube portion can seal a vascular rupture or another lesion at the position thereof, thereby preventing the flow of blood. In this way, the aortic endovascular structure and blood flow whole-course remodeling device does not rely on the membrane structure of covered stents in the prior art, and thus has improved durability, and also avoids the risk of membrane structure rupture. As the mesh structure of a mesh portion, especially a braided one, allows the shape of the mesh portion to change when subjected to an external force, the aortic endovascular structure and blood flow whole-course remodeling device has good compliance, enabling shearing and damage to vascular walls to be reduced.

Description

Aortic endovascular structure and blood flow remodeling device

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to Chinese patent application number CN202311042953X, filed with the China Patent Office on August 17, 2023, entitled “Device for global remodeling of aortic intraluminal structure and blood flow,” the entire contents of which are incorporated by reference into this disclosure. Technical Field

[0003] The present disclosure relates to the technical field of medical devices, and in particular to a device for remodeling the aortic endoluminal structure and blood flow throughout the entire process. Background Art

[0004] The main function of the aorta and its branches is to transport oxygenated blood to organs and tissues throughout the body. Under normal circumstances, there is a certain range of blood flow velocity and regular blood flow status. In the case of lesions such as aortic dissection / aortic aneurysm and aortic ulcer, the blood flow velocity and status change abnormally or become disordered, which may be the cause of the disease or the disease itself, and is a key factor causing further expansion or rupture of the aorta. Currently, both surgery and interventional treatment (such as through covered stents) can only partially treat this condition. Covered stents have poor compliance and are prone to damage to the blood vessel wall. In addition, the membrane structure of the covered stent has low durability and is often at risk of rupture and expiration of its service life.

[0005] Summary of the Invention

[0006] The present disclosure provides an aortic intraluminal structure and blood flow global remodeling device, characterized in that the aortic intraluminal structure and blood flow global remodeling device comprises:

[0007] a main body, the main body comprising a first tube portion, the first tube portion comprising a first mesh portion, the first mesh portion having a first density;

[0008] a closing portion, the closing portion being disposed on an inner wall of the first tube portion, the closing portion comprising a second mesh portion having a second density;

[0009] The first density is configured to allow liquid to pass through the first mesh portion, and the second density is configured to prevent liquid from passing through the second mesh portion.

[0010] Optionally, the closing portion is provided with an opening portion, and the opening portion is configured to allow fluid to pass through the opening portion.

[0011] Optionally, the opening portion is configured such that its shape and size do not change with the external force applied to the closing portion.

[0012] Optionally, the closing portion includes a second tube portion, the second tube portion includes the second net portion, and the second net portion occupies at least a portion of the first net portion in a length direction of the first tube portion.

[0013] Optionally, the second mesh portion occupies a portion of the first mesh portion in the length direction of the first tube portion, the second mesh portion is located at one end of the first mesh portion, and a portion of the first mesh portion is configured as a fixing portion for fixing the position of the aortic intraluminal structure and the blood flow global remodeling device.

[0014] Optionally, the second mesh portion occupies a portion of the first mesh portion in the length direction of the first tube portion, the second mesh portion is located in the middle portion of the first mesh portion, and at least a portion of at least one of the two parts of the first mesh portion that are not provided with the second mesh portion is configured as a fixing portion for fixing the position of the aortic intraluminal structure and the blood flow global remodeling device.

[0015] Optionally, an end portion of the second net-shaped portion in the length direction of the first tube portion has an inclined surface inclined relative to the length direction of the first tube portion.

[0016] Optionally, an end portion of the second net-shaped portion in the length direction of the first tube portion has a notch portion extending into the second net-shaped portion.

[0017] Optionally, the closing portion includes a sheet portion, the sheet portion includes the second mesh portion, and the sheet portion is arranged on an inner side of the first mesh portion.

[0018] Optionally, the closing portion further includes at least two third tube portions arranged in the first tube portion, adjacent third tube portions are arranged side by side, and the third tube portions include a third mesh portion, and the third mesh portion has the second density.

[0019] Optionally, the main body further includes a partition extending along a length direction of the first tube portion, and the partition partition divides a portion of the first tube portion into two adjacent parts.

[0020] The present disclosure also provides an aortic intraluminal structure and blood flow remodeling device, which includes a main body, the main body including a first tube portion, the first tube portion including a first mesh portion, the first mesh portion having a first density, the main body also including a partition portion, the partition portion extending along the length direction of the first tube portion, the partition portion separating a portion of the first tube portion into two adjacent parts, and the first density being configured to enable the first mesh portion to pass through liquid. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0022] FIG1 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to one embodiment of the present disclosure;

[0023] FIG2 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0024] FIG3 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0025] FIG4 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0026] FIG5 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0027] FIG6 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0028] FIG7 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0029] FIG8 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0030] FIG9 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0031] FIG10 shows a schematic structural diagram of an exemplary aortic intraluminal structure and a blood flow global remodeling device according to another embodiment of the present disclosure;

[0032] FIG11A is a schematic diagram showing an unformed state of a stent trunk of an exemplary aortic intraluminal structure and blood flow global remodeling device provided according to an embodiment of the present disclosure;

[0033] FIG11B shows a schematic diagram of an exemplary aortic endoluminal structure and a stent trunk of a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0034] FIG12A shows a schematic diagram of a first example of a first implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0035] FIG12B shows a schematic diagram of a second example of the first implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0036] FIG12C shows a schematic diagram of a third example of the first implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0037] FIG12D shows a schematic diagram of a fourth example of the first implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0038] FIG12E shows a schematic diagram of a fifth example of the first implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0039] FIG12F shows a schematic diagram of a sixth example of the first implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0040] FIG13A shows a schematic diagram of a first example of a second implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0041] FIG13B shows a schematic diagram of a second example of a second implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0042] FIG13C shows a schematic diagram of a stent trunk of a third example of the second implementation of the exemplary aortic endoluminal structure and blood flow global remodeling device provided according to an embodiment of the present disclosure;

[0043] FIG13D shows a schematic diagram of a third example of the second implementation of the exemplary aortic endoluminal structure and the device for global blood flow remodeling according to an embodiment of the present disclosure;

[0044] FIG14A shows a schematic diagram of a first example of a third implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0045] FIG14B shows a schematic diagram of a second example of a third implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0046] FIG15 is a schematic diagram showing a fourth implementation of an exemplary aortic endoluminal structure and a device for global blood flow remodeling according to an embodiment of the present disclosure;

[0047] FIG16 is a schematic diagram showing a front view of an exemplary aortic endoluminal structure and blood flow remodeling device according to an embodiment of the present disclosure;

[0048] FIG17 is a schematic diagram showing an axonometric view of an exemplary aortic endoluminal structure and blood flow remodeling device according to an embodiment of the present disclosure;

[0049] FIG18 is a schematic diagram showing a side view of an exemplary aortic endoluminal structure and blood flow remodeling device according to an embodiment of the present disclosure.

[0050] Reference numerals: 1000 - device for remodeling the intraluminal structure and blood flow of the aorta; 1200 - main body; 1220 - first tube portion; 1222 - first mesh portion; 1224 - fixing portion 1224; 1200A-stent trunk; 1240 (1240A)-partitioning part; 1400-closing part; 1420-second tube part; 1422-second mesh part, 1440-opening part; 1450-notch part; 1460-sheet part; 1400A-stent closing area; 1224A-anchoring area; 1440A-prefabricated window; 1450A-notch; 1460A-patch 1480-third tube part; 1482-third mesh part; 1500-occluder; 1510-front cone section; 1520-cylindrical section; 1530-rear cone section; 1540-limiting section. DETAILED DESCRIPTION

[0051] The technical solutions of the present disclosure will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the embodiments described are only a portion of the embodiments of the present disclosure, not all of them. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments of the present disclosure without creative effort are within the scope of protection of the present disclosure.

[0052] In the description of this disclosure, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate the description of this disclosure and simplify the description. They do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this disclosure. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0053] In the description of this disclosure, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they may refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this disclosure based on the specific circumstances.

[0054] In addition, the technical solutions between the various implementation methods can be combined with each other, but they must be based on the fact that ordinary technicians in this field can implement them. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by this disclosure.

[0055] 1 , an embodiment of the present disclosure provides an aortic intraluminal structure and blood flow global remodeling device 1000 , the aortic intraluminal structure and blood flow global remodeling device 1000 comprising:

[0056] The main body 1200 includes a first tube portion 1220 , the first tube portion 1220 includes a first mesh portion 1222 , and the first mesh portion 1222 has a first density;

[0057] A sealing portion 1400 , the sealing portion 1400 being disposed on the inner wall of the first tube portion 1220 , the sealing portion 1400 including a second mesh portion 1422 , the second mesh portion 1422 having a second density;

[0058] The first density is configured to allow liquid to pass through the first mesh portion 1222 , and the second density is configured to prevent liquid from passing through the second mesh portion 1422 .

[0059] In the above technical solutions, "density" is intended to characterize the degree of density of the corresponding mesh portion. The mesh portion can essentially be understood as having mesh holes. Here, "density" essentially characterizes the density of the mesh holes. When the density of the mesh holes within a certain area is greater, the mesh portion's ability to block liquids increases. Here, the mesh portion can be woven, for example, from a filamentous structure, a yarn-like structure, or a fiber structure. It is believed, without being bound by theory, that in the above technical solutions, the first tubular portion 1220 facilitates supporting the aortic endoluminal structure and blood flow remodeling device 1000 when inserted into the vessel. The first mesh portion 1222 included in the first tubular portion 1220 is configured to have a first density. At the first density, the first mesh portion 1222 is fluid-permeable. This allows the first mesh portion 1222 to pass through the opening of a branch vessel after being inserted into the main vessel. Due to the fluid-permeable nature of the first mesh portion 1222, blood flow from the main vessel to the branch vessel is not obstructed. In other words, in the above technical solution, the intervention of the first mesh portion 1222 does not hinder the flow of blood to the branch vessels.

[0060] It is believed, without being bound by theory, that in the above technical solution, the sealing portion 1400 includes a second mesh portion 1422. The second mesh portion 1422 can be formed in the same manner as the first mesh portion 1222, but the density of the second mesh portion 1422 is configured to be greater than the first density, thereby being able to block fluid, such as blood. When the sealing portion 1400 is disposed within the first tube portion 1220 of the main body 1200, the sealing portion 1400 disposed on the inner wall of the first tube portion 1220 can seal the vascular rupture or other lesion at its location, thereby preventing blood flow. In this way, the aortic intraluminal structure and blood flow remodeling device 1000 does not rely on the membrane structure of the coated stent in the prior art, has better durability, and does not have the risk of membrane structure rupture. The mesh structure of the mesh allows the mesh to change shape when subjected to external forces, especially for woven meshes. Therefore, the aortic intraluminal structure and blood flow remodeling device 1000 have better compliance, reducing shear and damage to the vessel wall. It will be understood that the second density herein is greater than the first density, which is a higher density.

[0061] It should be noted that the diameter and density of the mesh portion (referred to as density in the specific embodiment) are negatively correlated with the length of the mesh portion. The shorter the length of the mesh portion, the greater the diameter and density of the mesh portion. Optionally, the main body 1200 can be selected from the stent trunk 1200A. Optionally, in the above technical solution, the main body 1200 can be formed as the actual stent trunk 1200A in the aorta intraluminal structure and blood flow remodeling device 1000. Optionally, the closing portion 1400 can be selected from the stent closing area 1400A. Optionally, the closing portion 1400 can be formed as the actual stent closing area 1400A.

[0062] In the above technical solution, the first net portion 1222 can be a part of the first tube portion 1220, or the entire first tube portion 1220. Similarly, the second net portion 1422 can be an independent component included in the closing portion 1400, or a part of the closing portion 1400, or the entire closing portion 1400.

[0063] In some embodiments, referring to FIG. 2 , the sealing portion 1400 is provided with an opening 1440 , and the opening 1440 is configured to allow fluid to pass through the opening 1440 .

[0064] The above technical solution allows sealing portion 1400 to seal a vascular rupture or other lesion. If a vascular branch opening exists at the location corresponding to sealing portion 1400, the opening portion 1440 corresponding to the vascular branch can be used to direct blood flow toward the vascular branch without affecting blood flow to the vascular branch, thereby ensuring sufficient blood supply to the vascular branch. Opening portion 1440 can be prefabricated on sealing portion 1400 based on the location, shape, and size of the opening of the vascular branch to be addressed. This eliminates the tedious process of creating a fenestration during surgery, as is required with conventional stent grafts.

[0065] Optionally, the opening portion 1440 is configured such that its shape and size do not change with the external force applied to the closing portion 1400 .

[0066] In the above technical solution, although the mesh portion will change shape under the action of external forces, the opening portion 1440 is configured so that its shape and size do not change with the external forces applied to the closure portion 1400. This helps ensure that the prefabricated opening portion 1440 does not change shape and size during the process of the aortic endoluminal structure and blood flow remodeling device 1000 being inserted into the blood vessel, thereby causing poor correspondence with the opening of the vascular branch. In the above technical solution, the opening portion 1440 can be defined by a fixed structure connected to the closure portion 1400. The fixed structure can be annular or approximately annular. The fixed structure is used to limit the freedom of movement of the mesh to which the fixed structure is connected, or the fixed structure has a certain rigidity to withstand the push and pull of the mesh to which it is connected. Optionally, the opening portion 1440 can be selected from the prefabricated fenestration 1440A. Optionally, the opening portion 1440 can be formed as a substantially prefabricated fenestration 1440A.

[0067] In some embodiments, referring to FIG. 3 , the closing portion 1400 includes a second tube portion 1420 , the second tube portion 1420 includes a second mesh portion 1422 , and the second mesh portion 1422 occupies at least a portion of the first mesh portion 1222 in the length direction of the first tube portion 1220 .

[0068] In the above technical solution, the sealing portion 1400 includes a second tubular portion 1420, which includes the aforementioned second mesh portion 1422. Here, the second mesh portion 1422 can be the entire second tubular portion 1420 or a portion of the second tubular portion 1420. For example, if the second mesh portion 1422 is the entire second tubular portion 1420, the second mesh portion 1422 can be completely encased by the first mesh portion 1222. In other words, the second mesh portion 1422 is of equal length to the first mesh portion 1222 or is shorter than the first mesh portion 1222. Here, when the second mesh portion 1422 is of equal length to the first mesh portion 1222, the second mesh portion 1422 occupies the entire length of the first tubular portion 1220, that is, the entire axial direction of the aortic endoluminal structure and blood flow remodeling device 1000.

[0069] In some embodiments, referring to Figure 4, the second mesh portion 1422 occupies a portion of the first mesh portion 1222 in the length direction of the first tube portion 1220, and the second mesh portion 1422 is located at one end of the first mesh portion 1222. The portion of the first mesh portion 1222 is configured as a fixing portion 1224 for fixing the position of the aortic intraluminal structure and the blood flow global remodeling device 1000.

[0070] Alternatively, in the above technical solution, the length of the second mesh portion 1422 can be shorter than the length of the first mesh portion 1222. One end of the second mesh portion 1422 can be flush with one end of the first mesh portion 1222, while the other end of the second mesh portion 1422 can extend toward the other end of the first mesh portion 1222. This leaves a portion of the first mesh portion 1222 that is equal to the difference in length between the first and second mesh portions 1222 and that is not contained by the second mesh portion 1422. This portion still has the first density and can allow fluid, such as blood, to pass through. Here, the portion not contained by the second mesh portion 1422 can be configured as a fixing portion 1224 for fixing the aortic endoluminal structure and the position of the global blood flow remodeling device 1000. For example, the portion not accommodating the second mesh portion 1422 can fix the aortic intraluminal structure and blood flow remodeling device 1000 in the blood vessel without affecting blood flow. The portion not accommodating the second mesh portion 1422 is thus formed as a substantial anchoring area 1224A.

[0071] Optionally, the second mesh portion 1422 occupies the portion of the first mesh portion 1222 in the lengthwise direction of the first tubular portion 1220, is located in the middle of the first mesh portion 1222, and at least a portion of at least one of the two portions of the first mesh portion 1222 not provided with the second mesh portion 1422 is configured as a fixing portion 1224 for fixing the position of the aortic endoluminal structure and the global blood flow remodeling device 1000. Optionally, referring to FIG. 5 , the two portions of the first mesh portion 1222 not provided with the second mesh portion 1422 are configured as fixing portions 1224 for fixing the position of the aortic endoluminal structure and the global blood flow remodeling device 1000.

[0072] In the above technical solution, the second mesh portion 1422 is shorter than the first mesh portion 1222. Unlike the above technical solution, the ends of the second mesh portion 1422 are not flush with the first mesh portion 1222. Instead, the second mesh portion 1422 is located entirely in the middle of the first mesh portion 1222. The term "middle" here is intended to indicate that the ends of the second mesh portion 1422 are not flush with the ends of the first mesh portion 1222, and is not intended to imply that the second mesh portion 1422 is located in the exact middle of the first mesh portion 1222. Therefore, the two portions of the first mesh portion 1222 formed on either side of the second mesh portion 1422 due to the absence of the second mesh portion 1422 can be equal in length or unequal in length. One of these two portions can serve as the aforementioned fixing portion 1224 in part or in its entirety, or both portions can serve as the aforementioned fixing portion 1224 in part or in its entirety.

[0073] In some embodiments, referring to FIG. 6 , an end portion of the second net-shaped portion 1422 in the length direction of the first tube portion 1220 has an inclined surface that is inclined relative to the length direction of the first tube portion 1220 .

[0074] In some embodiments, referring to FIG. 7 , an end portion of the second net portion 1422 in the length direction of the first tube portion 1220 has a notch portion 1450 extending into the second net portion 1422 .

[0075] In the above technical solution, the shape of the notch portion 1450 can be substantially U-shaped. Alternatively, the notch portion 1450 can be selected from the notch 1450A. Alternatively, the notch portion 1450 can be formed as a substantial notch 1450A.

[0076] In some embodiments, referring to FIG. 8 , the closing portion 1400 includes a sheet portion 1460 , the sheet portion 1460 includes the second mesh portion 1422 , and the sheet portion 1460 is disposed inside the first mesh portion 1222 .

[0077] Alternatively, in the above technical solution, the sealing portion 1400 may not include the above-mentioned tubular structure, but may include a sheet portion 1460, which is directly disposed on the inner side of the first mesh portion 1222. Therefore, the sheet portion 1460 here is formed as a substantial patch 1460A. Alternatively, the sheet portion 1460 may be selected from the patch 1460A.

[0078] In some embodiments, referring to FIG. 9 , the closing portion 1400 further includes at least two third tube portions 1480 disposed within the first tube portion 1220 , adjacent third tube portions 1480 are disposed side by side, and the third tube portions 1480 include a third mesh portion 1482 , and the third mesh portion 1482 has the second density.

[0079] In the above technical solution, to cope with bifurcated branch vessels, the sealing portion 1400 can include at least two third tubular portions 1480, for example, two third tubular portions 1480 arranged side by side, each of which can be used to connect the bifurcated branch vessels. The third tubular portion 1480 can also include a mesh portion, here, a third mesh portion 1482, and have a second density capable of blocking fluid. Alternatively, the sealing portion 1400 can include four third tubular portions 1480, for example, four third tubular portions 1480 arranged side by side.

[0080] In addition, it should be noted that the second density here is intended to illustrate the density range that can block the passage of fluid, rather than specifically referring to a specific density value.

[0081] In some embodiments, referring to FIG. 10 , the main body 1200 further includes a partition 1240 extending along the length of the first tube portion 1220. The partition 1240 divides the first tube portion 1220 into two adjacent portions. In the following embodiments, the specific structure of the "partition" is described with reference number 1240A.

[0082] In the above technical solution, as an alternative to the valve stem of the previous technology, this technical solution uses the partition 1240 to form a side-by-side tube structure in the main body 1200 for connecting bifurcated branch blood vessels.

[0083] In some embodiments, the present disclosure provides an aortic intraluminal structure and blood flow global remodeling device 1000, which includes a main body 1200, wherein the main body 1200 includes a first tube portion 1220, the first tube portion 1220 includes a first mesh portion 1222, and the first mesh portion 1222 has a first density. The main body 1200 also includes a separator 1240, which extends along the length direction of the first tube portion 1220. The separator 1240 separates a portion of the first tube portion 1220 into two adjacent parts, and the first density is configured to enable the first mesh portion 1222 to be liquid-permeable.

[0084] The above independent technical solution, based on its technical features, has the same technical effects as the first independent technical solution. In fact, the above independent technical solution is a variant of the previous dependent technical solution without the sealing portion 1400. In other words, the main body 1200 including the partition 1240 can also be inserted into the blood vessel as the aortic intraluminal structure and blood flow remodeling device 1000.

[0085] In order to make the above-mentioned objectives, features and advantages of the present disclosure more obvious and easy to understand, some embodiments are specifically listed below and described in detail with reference to the accompanying drawings.

[0086] According to an embodiment of the present disclosure, an aortic intraluminal structure and blood flow global remodeling device 1000 is provided. The structure and working principle of the aortic intraluminal structure and blood flow global remodeling device 1000 will be described below with reference to FIG. 11A to FIG. 18 .

[0087] In an embodiment, the aortic endoluminal structure and blood flow global remodeling device 1000 is used for insertion into the aorta to treat conditions such as aortic dissection, aortic aneurysm, and aortic ulcer. For example, the aortic endoluminal structure and blood flow global remodeling device 1000 is embodied as a stent. By insertion into the aorta, the aortic endoluminal structure and blood flow global remodeling device 1000 achieves or promotes global remodeling of blood flow within the aorta.

[0088] In an embodiment, a device 1000 for global remodeling of the aortic endoluminal structure and blood flow includes a stent trunk 1200A and a stent encapsulation region 1400A. The stent trunk 1200A has a mesh-like tubular shape. In an embodiment, the stent trunk 1200A is formed as a substantially sparse mesh portion. That is, the mesh density of the tubular stent trunk 1200A is relatively low (i.e., lower than that of the stent encapsulation region 1400A), thereby forming a relatively sparse portion.

[0089] In some embodiments, the open mesh portion may be substantially formed by weaving an elastic fiber-like material, an elastic filament-like material, or an elastic yarn-like material, etc. Alternatively, the elastic fiber-like material, the elastic filament-like material, or the elastic yarn-like material may include a polymer compound (such as a resin), a metal (such as a nickel-titanium alloy, a cobalt-chromium alloy, tungsten, tantalum, palladium), etc.

[0090] In an embodiment, the sparse mesh portion can be essentially formed into a relatively sparse mesh arterial stent woven from nickel-titanium alloy wires, thereby serving as the backbone and foundation of the aortic endoluminal structure and blood flow remodeling device 1000. In an embodiment, the sparse mesh portion is constructed to have a supporting force, thereby maximally expanding the aortic true lumen and maximally adhering the aortic intima to the adventitia, thereby eliminating the false lumen.

[0091] In terms of function, the dredging part can play a role in guiding the fluid in the cavity involved, for example, guiding the blood. Taking the cavity involved as the aorta as an example, the dredging part can keep all aortic branches (such as the brachiocephalic vessels, intercostal arteries or abdominal visceral vessels) unobstructed for a long time to ensure effective blood supply to the distal organs. This is because when the aortic intraluminal structure and blood flow remodeling device 1000 is inserted into the intervened aorta, when the aortic intraluminal structure and blood flow remodeling device 1000 spans the branches of the aorta in length, due to the sparse characteristics of the dredging part, blood can still flow from the aorta through the mesh on the dredging part to the aortic branches, that is, as mentioned above, it can keep the aortic branches unobstructed for a long time. In other words, the part of the aortic intraluminal structure and blood flow remodeling device 1000 that spans the aortic branches is the dredging position of the aortic intraluminal structure and blood flow remodeling device 1000, which can ensure the patency of important branch blood vessels.

[0092] Next, the dredge mesh section can reduce blood flow velocity for small ruptures, aneurysms, or ulcers in the aortic intima that it can cover, utilizing the vortex-laminar principle to promote thrombosis within the false lumen and aneurysm. Furthermore, the dredge mesh section can serve as the primary portion of the anchoring region 1224A or as a connecting link between different stent segments. The dredge mesh section is designed to be riveted and secure, ensuring that the stent will not fall off or shift.

[0093] The stent enclosed region 1400A is formed as a substantially dense mesh portion. The dense mesh portion is denser than the sparse mesh portion, thereby providing a barrier to fluids, such as blood flow. In some embodiments, the dense mesh portion can be substantially woven from an elastic fiber-like material, an elastic filament-like material, or an elastic yarn-like material. Alternatively, the elastic fiber-like material, the elastic filament-like material, or the elastic yarn-like material can include a polymer compound (such as a resin), a metal (such as a nickel-titanium alloy, a cobalt-chromium alloy, tungsten, tantalum, or palladium), or the like. Alternatively, the dense mesh portion can be woven from metal yarn, metal fibers, or metal wires, woven into a dense mesh tube (e.g., a dense mesh blood vessel) or patch (i.e., a sheet-like mesh structure) with a higher density (relative to the density of the sparse mesh portion). In its natural state (i.e., when not subjected to external forces) or in a somewhat extended state (i.e., when subjected to a certain amount of external tension), the density (blood permeability) of the dense mesh portion is better than or comparable to that of currently available stent grafts. Therefore, the dense mesh part has an immediate sealing and isolating effect on aortic dissection, aortic aneurysm or ulcer.

[0094] In an embodiment, the dense mesh portion can have different forms, such as straight blood vessels, special-shaped blood vessels or patches, and be added to different positions of the stent trunk 1200A (i.e., the sparse mesh portion) with a two-layer mesh structure, so as to achieve the effect of immediately sealing aortic lesions of different types, different shapes and different locations.

[0095] In an embodiment, in addition to the stent trunk 1200A (the sparse mesh portion) and the stent closure region 1400A (the dense mesh portion), the aortic endoluminal structure and blood flow remodeling device 1000 further includes an anchoring region 1224A and prefabricated fenestrations 1440A. Furthermore, the aortic endoluminal structure and blood flow remodeling device 1000 also includes fenestrations and a localized occlusion device after the sparse mesh trunk. This allows the aortic endoluminal structure and blood flow remodeling device 1000 to fully or partially reconstruct the aorta and its branches, or in other words, to restore the normal anatomical structure of the aorta and its branches as much as possible, thereby meeting the clinical needs of treating aortic diseases.

[0096] Based on the stent backbone 1200A described above, the stent backbone 1200A can be, for example, a stent backbone 1200A having a two-layer mesh structure formed by folding a single layer of open-mesh metal blood vessels. For example, as shown in Figures 11A and 11B , Figure 11A shows a tubular structure formed by a single-layer mesh structure. Based on Figure 11A , along the fold line in the middle of Figure 11A (this fold line is merely for the purpose of facilitating the description of the forming process of the stent backbone 1200A and is not intended to indicate the existence of this line), one side of the tubular structure is folded over the other, so that the one side of the tubular structure is nested outside the other. The ends of the two sections are then connected and fixed to form the stent backbone 1200A. As described above, the stent backbone 1200A serves as a support and connection, forming the foundation for forming the aortic intraluminal structure and blood flow remodeling device 1000. As described above, the stent sealing area 1400A may be a dense network of blood vessels or patches of different structures added to different parts of the stent trunk 1200A to achieve the purpose of instantly sealing the aortic dissection rupture or isolating the aortic aneurysm and ulcer.

[0097] In the embodiment, as described above, stent trunk 1200A is constructed from two layers of open mesh folded in half and sealed at the edges. As stent trunk 1200A, it does not seal any ruptured aorta or any part of the aorta without aneurysms or ulcers, while maintaining long-term patency of blood flow to important aortic branches. Furthermore, after dilating the true lumen of the aortic dissection, stent trunk 1200A can significantly improve the perfusion of pre-existing poorly perfused branches.

[0098] In an embodiment, anchoring region 1224A is used to secure the position of the aortic endoluminal structure and global blood flow remodeling device 1000. Anchoring region 1224A can be a separate sparse mesh portion, i.e., a sparse mesh portion, i.e., a portion of the stent backbone 1200A; or anchoring region 1224A can be a sparse mesh portion combined with a dense mesh portion, i.e., anchoring region 1224A can include a portion of tubular sparse mesh and a portion of tubular dense mesh connected to each other. In an embodiment, the portion of tubular sparse mesh included in anchoring region 1224A can be a portion of the stent backbone 1200A, or a portion of tubular sparse mesh that is independent of and connected to the stent backbone 1200A. Alternatively, anchoring region 1224A can be a separate dense mesh portion, i.e., a dense mesh portion that is independent of and connected to the stent backbone 1200A.

[0099] In an embodiment, the anchoring region 1224A is located at the end of the aortic intraluminal structure and blood flow remodeling device 1000, for example, at the head end or both ends of the aortic intraluminal structure and blood flow remodeling device 1000 (i.e., the head end of the aortic intraluminal structure and blood flow remodeling device 1000 and the tail end of the aortic intraluminal structure and blood flow remodeling device 1000), so as to fix the aortic intraluminal structure and blood flow remodeling device 1000.

[0100] In an embodiment, the prefabricated window 1440A is formed as a window pre-opened on the stent enclosing area 1400A. The role of the prefabricated window 1440A is that when there is an important aortic branch at the position corresponding to the stent enclosing area 1400A, in order to ensure the blood supply of the branch, a window of corresponding size is prefabricated on the dense mesh stent, and an artificial blood vessel can be implanted from the window to the branch to establish blood traffic and restore the blood supply of the branch. In an embodiment, the prefabricated window is constructed so that its size and shape are not changed by the traction of the stent. In actual applications, the location and size of the prefabricated window 1440A can be completed under the guidance of 3D image reconstruction.

[0101] In the embodiment, the posterior fenestration is mainly used for chronic aortic dissection, where there are important abdominal organs branching out to the false lumen of the aorta. After the stent trunk 1200A is implanted, it is difficult to make the intima and adventitia of the aorta completely adhere after the true lumen is expanded, and the corresponding intima rupture of the branch has a large blood flow into the false lumen, especially with other ruptures. Therefore, in order to achieve a better long-term effect of the aortic intraluminal structure and blood flow remodeling device 1000 and achieve the purpose of thrombosis in the false lumen of the aorta, the aortic intraluminal structure and blood flow remodeling device 1000 according to the embodiment of the present disclosure can establish blood flow communication between the intima rupture of the aorta and the branch blood vessels through the gap of the corresponding part of the balloon expandable stent trunk 1200A, and achieve the effect of closing the intima rupture and the diversion of the false lumen.

[0102] In an embodiment, a localized closure device is applied to a sparse mesh portion, particularly near the opening of a major aortic branch. When a large blood shunt opening is present in this region, the shunt opening is directly sealed using the localized closure device rather than the stent closure region 1400A (e.g., a dense mesh vessel or patch). The localized closure device may be, for example, a coil or similar structure.

[0103] Compared with the stent grafts used in the prior art, the aortic intraluminal structure and blood flow remodeling device 1000 provided according to the embodiments of the present disclosure has the following advantages:

[0104] Good compliance: For blood vessels with relatively large curvature, such as the aortic arch, or the thoracic and abdominal aorta with large curvature and deformation, the aortic intraluminal structure and blood flow remodeling device 1000 have high compliance due to the mesh stent trunk 1200A and the stent sealing area 1400A, which greatly reduces the shear force and damage to the aortic wall or aortic intima, and reduces the incidence of aortic dissection.

[0105] Furthermore, due to the meshed stent trunk 1200A and stent sealing area 1400A, the aortic intraluminal structure and blood flow remodeling device 1000 expands vertically and uniformly outward toward the intima or aortic wall during deployment within the aorta. Pressure is evenly distributed across the meshed aortic intraluminal structure and blood flow remodeling device 1000, significantly reducing localized damage to the intima or wall. Unlike stent grafts, which have a relatively fixed length and diameter, the diameter, density, and length of the aortic intraluminal structure and blood flow remodeling device 1000 provided in accordance with the present disclosure are dynamically variable, depending on the morphology of the aortic intraluminal structure and blood flow remodeling device 1000 as a result of the external forces applied to the device. In an embodiment, the diameter and density of the aortic intraluminal structure and blood flow remodeling device 1000 are negatively correlated with the length of the aortic intraluminal structure and blood flow remodeling device 1000. The shorter the length of the aortic intraluminal structure and blood flow remodeling device 1000 (i.e., the closer to its natural state), the greater the diameter and density of the aortic intraluminal structure and blood flow remodeling device 1000.

[0106] When the anchoring region 1224A includes a portion of a dredging net, the anchoring region 1224A can also ensure the patency of blood flow to important branch vessels of the aorta through the dredging net structure.

[0107] In addition, the design of the prefabricated fenestration 1440A and the rear fenestration avoids the need for complex operations such as fenestration, chimney, branching or brachiocephalic artery artificial vascular bypass after the stent graft has been inserted into the aorta, thereby greatly reducing the difficulty of the operation and alleviating the patient's pain and burden.

[0108] Since the membrane structure of the stent graft in the prior art is not adopted, the aortic intraluminal structure and blood flow overall remodeling device 1000 provided according to the embodiment of the present disclosure is more durable than the existing stent graft. In other words, the durability of the aortic intraluminal structure and blood flow overall remodeling device 1000 is long-term, and there is no service life problem of the membrane structure of the stent graft and the risk of rupture of the membrane structure.

[0109] In the device 1000 for global aortic endoluminal structure and blood flow remodeling provided in the present embodiment, the stent trunk 1200A and the stent sealing region 1400A are both woven from metal. It is well known that metal possesses physical antibacterial properties because it uses its electric field to attract pathogens and rupture their cell walls, resulting in a long-term antibacterial effect. However, existing covered stents have relatively low antibacterial capabilities, leading to life-threatening and difficult-to-remediate postoperative infections. In some embodiments, the stent enclosed region 1400A may include 230 to 2000 wires (e.g., 300 to 1800, 500 to 1500, or 800 to 1200, such as 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100, 2200, 2300, 2400, 2500, 2600, 2700, 2800, 2900, 3000, 3100, 3200, 3300, 3400, 3500, 3600, 3700, 3800, 3900, 4000, 4100, 4200, 4300, 4400, 4500, 4600, 4700, 4800, 4900, 5000, 5100, 5200, 5300, 5400, 5500, 5600, 5700, 5800, 5900, 6000, 6100, 6200, 6300, 6400 The stent enclosing region 1400A is woven from metal wires (e.g., nickel-titanium alloy wires, cobalt-chromium alloy wires, tungsten wires, tantalum wires, etc.; optionally, the metal wires from the stent enclosing region may be nickel-titanium alloy wires, the same below). The diameter of the metal wires is 0.03 mm to 0.11 mm (e.g., 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.010 mm), so that the stent enclosing region 1400A has a high density and a cloth-like structure. In an embodiment, the stent trunk 1200A can be woven from at least two wires of different diameters, such as coarse metal wires and fine metal wires, wherein the diameter of the fine metal wires is 0.1 mm to 0.15 mm (e.g., 0.11, 0.12, 0.13, 0.14 mm), and the diameter of the coarse metal wires is 0.15 mm to 0.5 mm (e.g., 0.2, 0.3, 0.4 mm).

[0110] In practice, the ascending aorta has a large inner diameter, but a relatively short straight section, with the distal end forming the aortic arch, which curves nearly 180 degrees. This makes stent deployment in the ascending aorta more difficult. The stent trunk 1200A and stent sealing area 1400A of this embodiment possess a sufficient braid density and radial support force in their naturally deployed state. Therefore, only minimal axial compression is required to achieve the desired effective closure of the aortic intimal tear.

[0111] The ends of the stent trunk 1200A and the stent enclosing area 1400A (especially the proximal ends, where the radial support force of the stent is the largest) can be formed in a back-braiding manner. For the other end, if there is a burr that cannot be back-braided again, the burr can be located on the inner side of the bare stent by selecting a suitable arrangement of each layer; or if there are two layers of burrs, one layer of burrs can be back-braided a short distance and the other burr can be wrapped in the back-braided section, or when multiple stents are used in combination, a single layer or two layers of burrs can be overlapped and placed in another dense mesh stent. The stent trunk 1200A and the stent enclosing area 1400A of this embodiment have smooth ends, thereby avoiding mechanical damage to the inner wall of the blood vessel by the exposed wire ends (burrs).

[0112] As used herein, the "natural release state" of the stent referred to herein refers to a state in which the stent is not axially compressed and released when fixed in a 37±2°C water bath.

[0113] As used herein, the terms "dense mesh" and "sparse mesh" refer to a woven mesh structure. The mesh size of a sparse mesh, unless otherwise specified, refers to the length of the mesh at its widest point. For example, using a diamond-shaped mesh, the mesh size refers to the length of the longest diagonal of the diamond.

[0114] According to the embodiment of the present disclosure, the device 1000 for completely remodeling the aortic intraluminal structure and blood flow, through the coordination of components such as the stent trunk 1200A and the stent closure area 1400A, can perform a one-stage, complete treatment of most aortic dissections and complex aortic aneurysms or ulcers, and can even achieve the effect of curing the reconstruction of the aorta and its branches.

[0115] Based on the above description of the aortic intraluminal structure and blood flow global remodeling device 1000 provided according to an embodiment of the present disclosure, a specific example of the aortic intraluminal structure and blood flow global remodeling device 1000 will be further described below.

[0116] As shown in Figures 12A to 12F, Figures 12A to 12F illustrate various examples of a first implementation of an aortic intraluminal structure and blood flow remodeling device 1000 according to an embodiment of the present disclosure. Based on a stent trunk 1200A, stent closure regions 1400A of varying shapes and configurations (e.g., straight or shaped blood vessels or patches, etc.) are attached to different locations on the stent trunk 1200A to precisely seal dissection ruptures, aneurysms, or ulcers. It should be noted that the aortic intraluminal structure and blood flow remodeling device 1000 shown in Figures 12A to 12F have varying lengths and differ somewhat from the other figures. However, this is not intended to imply that the aortic intraluminal structure and blood flow remodeling device 1000 in the various implementations shown in the figures of the present disclosure actually exhibit such differences. In fact, unless the aortic intraluminal structure and the device for global blood flow remodeling 1000 in two figures are explicitly cited in the above and below descriptions, and the lengths of the aortic intraluminal structure and the device for global blood flow remodeling 1000 in the two figures are compared, the difference in the length of the aortic intraluminal structure and the device for global blood flow remodeling 1000 shown in each figure is only for reference.

[0117] As shown in FIG12A , FIG12A illustrates a first example of a first implementation of a device for global aortic endoluminal structure and blood flow remodeling 1000 according to an embodiment of the present disclosure. In this example, based on a stent trunk 1200A, a tubular stent enclosed region 1400A is provided within the stent trunk 1200A of the device for global aortic endoluminal structure and blood flow remodeling 1000. Specifically, this straight tubular stent enclosed region 1400A comprises a dense mesh portion. Stent enclosed region 1400A extends from one end of the stent trunk 1200A toward the middle of the stent trunk 1200A, thereby occupying a portion of the stent trunk 1200A from one end toward the middle. In this example, the anchoring region 1224A of the device for global aortic endoluminal structure and blood flow remodeling 1000 can be provided by a portion of the sparse mesh portion on the left side of the stent trunk 1200A in the figure.

[0118] As shown in FIG12B , FIG12B illustrates a second example of the first implementation of the aortic endoluminal structure and blood flow remodeling device 1000 according to an embodiment of the present disclosure. In this example, the difference from the example in FIG12A lies in the location of the stent encapsulation region 1400A. The stent encapsulation region 1400A extends from one end of the stent trunk 1200A proximal to the other end of the stent trunk 1200A, occupying a section of the middle portion of the stent trunk 1200A. The stent trunk 1200A also includes two dredging portions located on either side of the stent encapsulation region 1400A. For example, these two dredging portions can have different lengths, with the shorter dredging portion serving as the anchoring region 1224A of the aortic endoluminal structure and blood flow remodeling device 1000.

[0119] As shown in FIG12C , FIG12C illustrates a second example of the first implementation of the device for global aortic endoluminal structure and blood flow remodeling 1000 according to an embodiment of the present disclosure. In this example, the difference from the example in FIG12B lies in the difference in the proportion of the stent body occupied by the stent encapsulation area 1400A. In FIG12C , the proportion of the stent body occupied by the stent encapsulation area 1400A is larger than that in the example in FIG12B , allowing both of the two sparse mesh portions at both ends of the stent body to serve as anchoring regions 1224A. For example, the two sparse mesh portions can be of the same length.

[0120] FIG12D illustrates a fourth example of a first implementation of the aortic intraluminal structure and blood flow remodeling device 1000 according to an embodiment of the present disclosure. Unlike the examples shown in FIG12A through FIG12C , FIG12D illustrates a different structure of the stent enclosing region 1400A. Referring to FIG12D , the stent enclosing region 1400A can still be tubular, and the tubular stent enclosing region 1400A can have an axially inclined end. In an embodiment, the distal end of the inclined surface (i.e., the rightmost end in FIG12D ) can be flush with the end of the stent trunk 1200A. Thus, after the stent enclosing region 1400A is installed within the stent trunk 1200A, the stent trunk 1200A is divided into a sparse mesh portion with inclined extending sides and a straight sparse mesh portion. The straight sparse mesh portion can serve as the anchoring region 1224A of the aortic intraluminal structure and blood flow remodeling device 1000.

[0121] Alternatively, as shown in FIG12E , FIG12E illustrates a fifth example of the first implementation of the aortic intraluminal structure and blood flow remodeling device 1000 according to an embodiment of the present disclosure. In this example, unlike the example in FIG12D , the structure of the stent enclosing region 1400A is different. In this example, the stent enclosing region 1400A has a notch 1450A at one end extending toward the center of the stent enclosing region 1400A. Similarly, after the stent enclosing region 1400A is installed within the stent trunk 1200A, the stent trunk 1200A is divided into a sparse mesh portion having a structure compatible with the notch 1450A and a straight sparse mesh portion. The straight sparse mesh portion can serve as the anchoring region 1224A of the aortic intraluminal structure and blood flow remodeling device 1000.

[0122] As shown in FIG12F , FIG12F illustrates a sixth example of the first implementation of the aortic endoluminal structure and blood flow remodeling device 1000 according to an embodiment of the present disclosure. In this example, unlike the examples shown in FIG12A through FIG12E , the structure of the stent encapsulation region 1400A is different. In this example, the stent encapsulation region 1400A can be sheet-shaped, i.e., a patch as described above. This patch can be positioned inside the stent trunk 1200A, while the remaining areas not covered by the patch are a sparse mesh portion. The portion of this sparse mesh portion located at the end of the aortic endoluminal structure and blood flow remodeling device 1000 can serve as the anchoring region 1224A of the aortic endoluminal structure and blood flow remodeling device 1000.

[0123] As shown in Figures 13A to 13D, various examples of a second implementation of the aortic endoluminal structure and blood flow remodeling device 1000 according to an embodiment of the present disclosure are shown. The aortic endoluminal structure and blood flow remodeling device 1000 in these examples can be applied to a scenario where the abdominal aorta is connected to the bifurcated iliac arteries.

[0124] As shown in FIG13A , FIG13A illustrates a first example of a second implementation of an aortic intraluminal structure and blood flow remodeling device 1000 according to an embodiment of the present disclosure. In this example, the aortic intraluminal structure and blood flow remodeling device 1000 includes two stent-enclosed regions 1400A disposed side by side within a stent trunk 1200A. Both stent-enclosed regions 1400A may have a straight tubular mesh structure. In this example, the area occupied by the two stent-enclosed regions 1400A is flanked by two sparse mesh sections, one of which is longer than the other. The shorter sparse mesh section serves as the anchoring region 1224A of the aortic intraluminal structure and blood flow remodeling device 1000.

[0125] As shown in FIG13B , FIG13B illustrates a second example of a second implementation of the aortic endoluminal structure and blood flow remodeling device 1000 according to an embodiment of the present disclosure. In this example, the aortic endoluminal structure and blood flow remodeling device 1000 still includes two stent-enclosed areas 1400A disposed side by side within the stent trunk 1200A. Both stent-enclosed areas 1400A may also have straight tubular mesh structures. In this example, the area occupied by the two stent-enclosed areas 1400A is flanked by two sparse mesh portions, one of which is longer than the other. Furthermore, a further stent-enclosed area 1400A may be disposed between the longer sparse mesh portion and the two stent-enclosed areas 1400A. This stent-enclosed area 1400A has a straight tubular mesh structure, and the shorter sparse mesh portion serves as the anchoring region 1224A of the aortic endoluminal structure and blood flow remodeling device 1000.

[0126] As shown in conjunction with Figures 13C and 13D, Figure 13C shows an example of the structure of a stent trunk 1200A. In this example, a section at the end of the stent trunk 1200A is divided into two parts by a partition 1240A extending axially. The partition 1240A can be formed by connecting the inner walls of a section at the end of the stent trunk 1200A. Thus, the example shown in Figure 13C, as a stent trunk 1200A, has a bifurcated structure similar to that formed in Figures 13A and 13B. On this basis, Figure 13D shows a third example of the second implementation of the aortic intraluminal structure and blood flow remodeling device 1000 provided in accordance with an embodiment of the present disclosure. Based on the stent trunk 1200A of Figure 13C, the example in Figure 13D includes a stent closure area 1400A provided axially inside the sparse mesh portion that has been divided into two parts. The anchoring region 1224A of the device for global remodeling of aortic endoluminal structure and blood flow 1000 may be a portion of the open mesh portion of the stent sealing region 1400A that is away from the open mesh portion divided into two parts (ie, the left side in FIG. 13D ).

[0127] Furthermore, although not shown in the figures, for all of the examples of the aortic intraluminal structure and blood flow global remodeling device 1000 in Figures 13A through 13D , a stent enclosed region 1400A, conforming to the inner wall of the stent trunk 1200A, can be provided throughout the entire span of the stent trunk 1200A. Specifically, for the examples in Figures 13A and 13B , except for the side-by-side tubular stent enclosed regions 1400A, the remaining open mesh portion of the stent trunk 1200A can be entirely provided with the stent enclosed region 1400A located in the middle as shown in Figure 13B , and similarly for Figure 13D .

[0128] As shown in Figures 14A and 14B , the aortic intraluminal structure and blood flow remodeling device 1000 provided according to embodiments of the present disclosure includes examples of pre-fabricated fenestrations 1440A in the dense mesh portion. When the stent trunk 1200A of the aortic intraluminal structure and blood flow remodeling device 1000 is positioned to seal and isolate an aortic aneurysm or ulcer, it may obstruct the main aortic branches. To ensure blood flow to the branches, appropriately sized windows are pre-deposited in appropriate locations within the dense mesh portion to establish blood flow communication with the branches. In essence, the aortic intraluminal structure and blood flow remodeling device 1000 with pre-fabricated fenestrations 1440A provided according to embodiments of the present disclosure can be formed into a fenestrated stent that substantially encompasses the aortic arch and celiac artery branches.

[0129] In the two examples of Figures 14A and 14B , a stent enclosed region 1400A, or dense mesh portion, is provided in the central portion of the stent trunk 1200A. The portion of the stent trunk 1200A not occupied by the stent enclosed region 1400A is thus formed into two portions located on either side of the stent enclosed region 1400A. Both portions are sparse mesh portions, which can serve as anchoring regions 1224A for the aortic endoluminal structure and blood flow remodeling device 1000. The difference between the two examples in Figures 14A and 14B lies in the form of the prefabricated fenestrations 1440A in the stent enclosed region 1400A. The stent enclosed region 1400A of the aortic endoluminal structure and blood flow remodeling device 1000 in Figure 14A has three prefabricated fenestrations 1440A, arranged substantially along the axial direction of the aortic endoluminal structure and blood flow remodeling device 1000. In FIG14B , the stent sealing region 1400A of the device for global aortic intraluminal structure and blood flow remodeling 1000 is provided with four prefabricated windows 1440A. Two of the prefabricated windows 1440A are substantially arranged along the axial direction of the device for global aortic intraluminal structure and blood flow remodeling 1000, and the other two prefabricated windows 1440A are substantially arranged along the circumference of the stent trunk 1200A of the device for global aortic intraluminal structure and blood flow remodeling 1000.

[0130] In addition, the aortic intraluminal structure and blood flow remodeling device 1000 according to the embodiment of the present disclosure can also be used for branched blood vessels, for example, for intraluminal implantation or bridging connection of aortic branches, such as the iliofemoral artery, brachiocephalic vessels (innominate artery, left common carotid artery and left subclavian artery), and abdominal visceral vessels (celiac artery, superior mesenteric artery and left and right renal arteries). The aortic intraluminal structure and blood flow remodeling device 1000 in this example can be used in combination with the above-mentioned aortic intraluminal structure and blood flow remodeling device 1000, or can be used alone. In an embodiment, as shown in FIG15 , the aortic intraluminal structure and blood flow remodeling device 1000 can be used for branched blood vessels by using the stent closure area 1400A to completely occupy the stent trunk 1200A on the basis of the stent trunk 1200A. In other examples, the example in FIG12A can also be used for branched blood vessels.

[0131] In embodiments, the various examples of the aforementioned aortic endoluminal structure and blood flow remodeling device 1000 can be used in combination. Specifically, aortic diseases primarily include aortic dissection, aortic aneurysm (true and false), aortic ulcers, and aortic branch lesions (dissection, aneurysmal dilatation, ulcers, or stenosis, etc.). Depending on clinical requirements such as the nature of the lesion, anatomical features, and therapeutic objectives, combining various examples of the aortic endoluminal structure and blood flow remodeling device 1000 can facilitate the achievement of a primary treatment or cure.

[0132] The goal of aortic dissection is first to eliminate the primary rupture, then to dilate the true lumen, improve blood supply to distal organs, and finally to close or thrombose the false lumen, achieving clinical treatment or cure. Aortic dissections include residual dissection, type B dissection, and type A dissection.

[0133] Residual dissection refers to residual dissection distal to the stent after Sun's surgery for type A dissection, interventional treatment for type B dissection, or intraoperative stent placement. Patients face the risk of distal aortic dilatation, re-operative intervention, inadequate blood supply to distal organs, and difficulty controlling blood pressure. For most residual dissections, especially those within one year of onset without major secondary ruptures, a fully ventilated stent can achieve excellent clinical efficacy, such as by using a combination of the stent trunk 1200A in Figure 11B, one of the aortic endoluminal structure and blood flow remodeling device 1000 in Figures 13A, 13B, and 13D, and the aortic endoluminal structure and blood flow remodeling device 1000 in Figure 15.

[0134] If there is a large secondary rupture in the intima of the thoracic and abdominal aorta, a dense mesh (i.e., the stent sealing area 1400A) can be added to the corresponding location to achieve better therapeutic effects, such as one of the aortic intraluminal structure and blood flow remodeling device 1000 in Figures 12A to 12F + one of the aortic intraluminal structure and blood flow remodeling device 1000 in Figures 13A, 13B, and 13D + the combination of the aortic intraluminal structure and blood flow remodeling device 1000 in Figure 15.

[0135] If the residual dissection only involves the thoracic and abdominal aorta without involving the bilateral iliac arteries, a simple stent trunk 1200A or a straight stent with a dense mesh (i.e., the aortic intraluminal structure and blood flow remodeling device 1000 in Figure 12A or Figure 15) can be used.

[0136] In chronic residual dissection, the false lumen is significantly expanded, with branches of important abdominal organs opening into the false lumen. After implantation of the Aortic Intraluminal Structure and Blood Flow Remodeling Device 1000, significant blood flow enters the false lumen through the intimal rupture, particularly with communication with other ruptures. Posterior fenestration can be used to create an artificial vascular bridge between the intimal rupture and the organ branches, sealing the shunt between the intimal rupture and the false lumen and promoting thrombosis of the false lumen.

[0137] For type B dissection, since there is a primary rupture near or distal to the left subclavian artery opening, the first segment of the aortic endoluminal structure and blood flow remodeling device 1000 uses one of the aortic endoluminal structures and blood flow remodeling devices 1000 shown in Figures 12A to 12F to immediately and tightly seal the rupture. The remaining dissection treatment options are similar to those described above for residual dissection.

[0138] For type A dissection, the aortic root or ascending aorta has been previously replaced. The aortic endoluminal structure and blood flow remodeling device 1000 in the proximal ascending aorta is connected to a graft using the stent trunk 1200A shown in FIG11B . The remaining treatment is similar to the aforementioned combination treatment for residual dissection. For example, a combination of the stent trunk 1200A shown in FIG11B + the stent trunk 1200A shown in FIG11B + one of the aortic endoluminal structure and blood flow remodeling device 1000 shown in FIG13A , FIG13B , and FIG13D + one of the aortic endoluminal structure and blood flow remodeling device 1000 shown in FIG14A and FIG14B can be selected.

[0139] For type A1 dissections, where the rupture is in the ascending aorta, the proximal densified mesh of the aortic endoluminal structure and blood flow remodeling device 1000 (i.e., one of the aortic endoluminal structure and blood flow remodeling devices 1000 in Figures 12A to 12F ) is selected to immediately and tightly seal the primary rupture in the ascending aorta. The opening of the brachiocephalic vessels is ensured to be located in a decongested area to ensure blood flow to the brain. The remaining treatment is similar to the treatment combination for residual dissection.

[0140] For type A1 dissections, where the rupture is located in the descending aortic arch (distal to the left subclavian artery), a proximal-end densified aortic endostructure and blood flow remodeling device 1000 (i.e., one of the aortic endostructures and blood flow remodeling devices 1000 in Figures 12A to 12F ) is selected. The proximal end is positioned distal to the opening of the left subclavian artery, instantly and tightly sealing the primary rupture. The stent trunk 1200A in Figure 11B is then placed between the ascending aorta and aortic arch, with the proximal end positioned at the sinotubular junction and the distal end connected to the first aortic endostructure and blood flow remodeling device 1000. The remaining treatment is the same as for residual dissection.

[0141] Aortic aneurysms are divided into two categories: those involving or not involving important aortic branches. For aneurysms or ulcers that do not involve aortic branches, located in the descending thoracic or abdominal aorta, one of the appropriate aortic endoluminal structures and blood flow remodeling devices 1000 in Figures 12A to 12F is used according to the extent and diameter of the aortic aneurysm. For aortic arch aneurysms that involve the brachiocephalic vessels, the aortic endoluminal structure and blood flow remodeling device 1000 in Figure 14A of the aortic arch with a prefabricated fenestration and densification mesh is selected, and the aortic endoluminal structure and blood flow remodeling device 1000 in Figure 15 of the three brachiocephalic artery branches is used to complete the isolation of the arch aneurysm.

[0142] For thoracic and abdominal aortic aneurysms involving the celiac artery, if there are normally anchored aortas at both the upper and lower ends, the prefabricated dense mesh fenestrated thoracic and abdominal aorta with the aortic intraluminal structure and blood flow remodeling device 1000 shown in Figure 14B is selected, and the aortic intraluminal structure and blood flow remodeling device 1000 shown in Figure 15 for the celiac artery (celiac trunk, inferior mesenteric and bilateral renal arteries) is added to isolate the aneurysm.

[0143] For extensive thoracic and abdominal aortic aneurysms involving the celiac artery and iliac arteries, a combination of the dense mesh fenestrated aortic intraluminal structure and blood flow remodeling device 1000 in Figure 14B + the bifurcated aortic intraluminal structure and blood flow remodeling device 1000 (one of the aortic intraluminal structure and blood flow remodeling device 1000 in Figures 13A, 13B, and 13D) + bilateral dense mesh iliac artery branch stents (the aortic intraluminal structure and blood flow remodeling device 1000 in Figure 15) is used, depending on the scope and length of the aneurysm involvement.

[0144] In addition, for aortic branch vessel lesions (dissection, tumor-like dilatation, ulcer or stenosis, etc.), a branch aortic intraluminal structure and blood flow remodeling device 1000 (the aortic intraluminal structure and blood flow remodeling device 1000 in Figure 15) can be prefabricated or customized and used alone or in combination with other above-mentioned aortic intraluminal structures and blood flow remodeling devices 1000 to solve branch lesions and maintain vascular patency.

[0145] Furthermore, for the aortic endoluminal structure and blood flow remodeling device 1000 provided according to the embodiments of the present disclosure, to maximize expansion of the aortic true lumen diameter, maximize adhesion of the intima and adventitia of the dissecting layer, and eliminate false lumen and endoleaks, when releasing the aortic endoluminal structure and blood flow remodeling device 1000, both ends of the device should be pushed up and pulled down as much as possible. This process should be repeated to minimize the length of the device 1000 and ensure optimal results. Depending on the intraoperative situation, the procedure of pushing up first and then pulling down, or pulling down first and then pushing up, can be selected based on which portion of the true lumen is to be expanded first and which end of the aortic endoluminal structure and blood flow remodeling device 1000 is to be secured first. Typically, the upper end is released first, followed by the lower end. When releasing the upper end, pull down to release it, and when releasing the lower end, push firmly to release it, to ensure the maximum diameter of the stent after release.

[0146] Furthermore, if the distal end of the superior aorta endoluminal structure and blood flow remodeling device 1000 is not fully expanded or is not expanded to its ideal state after release, this can be improved by performing certain operations during the release of the inferior aorta endoluminal structure and blood flow remodeling device 1000. After the inferior aorta endoluminal structure and blood flow remodeling device 1000 enters and partially intersects the superior aorta endoluminal structure and blood flow remodeling device 1000, the inferior aorta endoluminal structure and blood flow remodeling device 1000 is first pushed upward to expand the upper end of the device 1000 and intersect with the distal end of the superior aorta endoluminal structure and blood flow remodeling device 1000. The inferior aorta endoluminal structure and blood flow remodeling device 1000 is then pushed upward as a whole to move the distal end of the superior aorta endoluminal structure and blood flow remodeling device 1000 upward, shortening its length and achieving the purpose of expanding the diameter. In addition, when releasing the end of the iliac artery branch stent, it can be pulled down appropriately to release it, so as to avoid excessive upward push after release, which may cause the inner layer of the aortic intraluminal structure and blood flow remodeling device 1000 to fold and deform, resulting in stenosis within the stent.

[0147] Furthermore, the edges of the aortic intraluminal structure and blood flow remodeling device 1000 are configured to be smooth. After processing, such as sewing, the ends of the aortic intraluminal structure and blood flow remodeling device 1000 form a "flare" shape upon release. Each segment of the aortic intraluminal structure and blood flow remodeling device 1000 can be released independently, without damaging the aortic intima. Furthermore, key locations of the aortic intraluminal structure and blood flow remodeling device 1000 should be clearly marked to ensure accurate positioning of the stent during release. These markings can be made of tantalum wire.

[0148] In addition, as shown in Figures 16 to 18, the aortic endoluminal structure and blood flow remodeling device 1000 provided in accordance with an embodiment of the present disclosure may further include an occluder 1500. The occluder 1500 has an axial direction and may include a front cone section 1510, a cylindrical section 1520, a rear cone section 1530, and a stopper section 1540 sequentially connected along the axial direction. Both the front cone section 1510 and the rear cone section 1530 are truncated cone-shaped and may be coaxially arranged with the cylindrical section 1520. The front cone section 1510 facilitates guiding the occluder 1500 into the area to be occluded, while the rear cone section 1530 facilitates guiding the area to be occluded toward the stopper section. In an embodiment, the stopper section 1540 has the same diameter as the smaller diameter side of the rear cone section 1530 and includes a truncated cone-shaped portion. Together, the stopper section 1540 and the rear cone section 1530 form a groove-shaped structure that serves to limit the area to be occluded.

[0149] As an example, the outer diameters of the cylindrical section 1520, the large-diameter side of the front cone section 1510, and the large-diameter side of the rear cone section 1530 can be 10 mm. The front cone section 1510 has an opening with an inner diameter of 2 mm. Both the front cone section 1510 and the rear cone section 1530 are 2 mm long. The truncated cone portion of the retaining section 1540 is 1 mm long, and the small cylindrical portion adjacent to it is 1 mm long and has a diameter (i.e., the diameter of the small-diameter side of the truncated cone portion is 2 mm). The diameter of the large-diameter side of the truncated cone portion is 5 mm. The total length of the occluder can be 17 mm.

[0150] Based on the structure of the stent described above, the stent delivery system will be further described below. Those skilled in the art will understand that the stent according to the embodiments of the present disclosure may have more openings, and thus the stent delivery system according to the embodiments of the present disclosure may have multiple sets of first guidewire openings, second guidewire openings, and slits corresponding to the openings, as well as multiple guidewire tubes.

[0151] The stent delivery system includes a delivery catheter and the aforementioned stent. The delivery catheter includes an outer catheter and a push rod coaxially arranged along the catheter axis. The outer catheter has a proximal end and a distal end, and a hollow cavity extending therebetween. The hollow cavity has a proximal end and a distal end. The push rod extends axially and is coaxially arranged with the outer catheter.

[0152] The stent is releasably retained in the proximal end of the hollow body of the outer catheter in a delivery configuration.

[0153] As an example, a mechanism (not shown) for preventing the stent from moving, such as a bump or other structure, may be provided on the inner wall of the proximal end of the outer catheter or at an appropriate position of the pushing rod, but is not limited thereto.

[0154] The bracket can be a bracket having any of the aforementioned structures. In this embodiment, the bracket can have an opening.

[0155] In addition, a first guidewire opening is provided on the proximal end of the outer catheter in this embodiment, opposite to the opening of the stent, through which a guidewire of a delivery system for a branch stent can be passed to locate the branch vessel according to the stent placement method described in detail below.

[0156] The outer catheter can be moved axially relative to the push rod by manipulating the push rod, thereby releasing the stent. In this embodiment, after the delivery system is guided to the treatment site via a first guidewire and the opening of the stent is roughly aligned with the branch vessel via a second guidewire, the push rod is manipulated to move the proximal end of the delivery catheter toward the proximal end, separating the proximal end from the distal end of the outer catheter, thereby releasing the stent from its distal end.

[0157] In this embodiment, a slit is provided on the outer catheter wall on one side of the first guide wire opening in the direction of movement of the outer catheter when releasing the stent, so that when the outer catheter is moved to release the stent, the second guide wire that has been positioned in the branch vessel can remain in the branch vessel as the stent is released.

[0158] During stent release, the outer catheter moves along the aforementioned axial direction. A first guidewire opening is defined in the outer catheter wall. A slit is provided parallel to the aforementioned axial direction on the side of the first guidewire opening opposite to the outer catheter's movement direction (i.e., the side closer to the distal end). The slit is wide enough to allow at least the second guidewire to move within the slit.

[0159] According to another example of this embodiment, when releasing the stent, the outer catheter moves toward the distal end, wherein the proximal end and the head of the delivery system move away from each other (i.e., the entire outer catheter moves toward the distal end relative to the head), thereby releasing the stent from its proximal end. In this example, the slit can be provided on the side of the first guidewire opening near the distal end.

[0160] The stent release method applicable to the present invention may be any existing suitable method. Those skilled in the art may reasonably set the position of the slit according to specific circumstances to complete the stent placement process described in detail below.

[0161] The guide wire tube can be a flexible tube made of any suitable material, with an outer diameter of 2 to 6 mm and an inner diameter of 1.7 to 5.8 mm. Examples of usable materials include, but are not limited to, stainless steel, pebax (nylon elastomer), PTFE, and PU.

[0162] According to other examples, the delivery catheter may further include an inner catheter (not shown) coaxially arranged with the outer catheter, so that the stent can be maintained in the space between the outer catheter and the inner catheter. The guide wire tube is then correspondingly arranged in the hollow cavity of the inner catheter. When the delivery system has the inner catheter, the inner catheter is also provided with an opening corresponding to the outer catheter that is convenient for the guide wire tube to pass through. Optionally, the inner catheter may also have a slit that is convenient for the guide wire tube to maintain its position during the release of the stent. In addition, the delivery catheter (such as outer catheter) of the stent delivery system in the embodiment of the present disclosure generally has an outer diameter of approximately 4 to 10 mm (i.e., 12 to 30 Fr), and a length of approximately 500 to 1000 mm.

[0163] The foregoing is merely a preferred embodiment of the present disclosure, and the foregoing description is provided to enable others skilled in the art to best utilize the various aspects of the exemplary embodiments disclosed herein. This exemplary description is not intended to be exhaustive or limited to any precise form disclosed. Many modifications and variations are possible without departing from the spirit and scope of the present disclosure. The embodiments of the present disclosure should be considered in all respects as illustrative and not restrictive. Reference should be made to the appended claims and their equivalents when determining the scope of the present disclosure. Industrial Applicability

[0164] The aortic intraluminal structure and blood flow full-range remodeling device provided by the present disclosure can not only seal the blood vessel rupture or other lesions at the location and prevent blood flow, but also does not rely on the membrane structure of the covered stent in the prior art, has better durability, and does not have the risk of membrane structure rupture. In addition, it has good compliance and can reduce shearing and damage to the blood vessel wall. Therefore, the aortic intraluminal structure and blood flow full-range remodeling device provided by the present disclosure can be widely used in the field of medical device technology and has excellent industrial applicability.

Claims

1. A device for remodeling the aortic endoluminal structure and blood flow, characterized in that: The aortic intraluminal structure and blood flow full-process remodeling device comprises: A main body, the main body comprising a first tube portion, the first tube portion comprising a first mesh portion, the first mesh portion having a first density; A closing portion, the closing portion being disposed on an inner wall of the first tube portion, the closing portion comprising a second mesh portion, the second mesh portion having a second density; The first density is configured to allow liquid to pass through the first mesh portion, and the second density is configured to allow the second mesh portion to block liquid from passing through.

2. The aortic intraluminal structure and blood flow global remodeling device according to claim 1, characterized in that: The closing portion is provided with an opening portion configured to allow a fluid to pass through the opening portion.

3. The aortic intraluminal structure and blood flow global remodeling device according to claim 2, characterized in that: The opening portion is configured such that its shape and size do not change with the external force applied to the closing portion.

4. The device for global remodeling of the aortic endoluminal structure and blood flow according to any one of claims 1 to 3, characterized in that: The closing portion includes a second tube portion, the second tube portion includes the second net portion, and the second net portion occupies at least a portion of the first net portion in a length direction of the first tube portion.

5. The device for overall remodeling of aortic endoluminal structure and blood flow according to claim 4, characterized in that: The second mesh portion occupies a portion of the first mesh portion in the length direction of the first tube portion, the second mesh portion is located at one end of the first mesh portion, and a portion of the first mesh portion is configured as a fixing portion for fixing the position of the aortic intraluminal structure and the blood flow global remodeling device.

6. The device for global remodeling of aortic endoluminal structure and blood flow according to claim 4 or 5, characterized in that: The second mesh portion occupies a portion of the first mesh portion in the length direction of the first tube portion, the second mesh portion is located in the middle portion of the first mesh portion, and at least a portion of at least one of the two portions of the first mesh portion that are not provided with the second mesh portion is configured as a fixing portion for fixing the position of the aortic intraluminal structure and the global blood flow remodeling device.

7. The device for global remodeling of the aortic endoluminal structure and blood flow according to any one of claims 4 to 6, characterized in that: An end portion of the second net-like portion in the length direction of the first tube portion has a slope that is inclined with respect to the length direction of the first tube portion.

8. The device for global remodeling of the aortic endoluminal structure and blood flow according to any one of claims 4 to 7, characterized in that: An end portion of the second net-shaped portion in the length direction of the first tube portion has a notch portion extending into the second net-shaped portion.

9. The device for global remodeling of the aortic endoluminal structure and blood flow according to any one of claims 1 to 10, characterized in that: The closing portion includes a sheet portion, the sheet portion includes the second net-shaped portion, and the sheet portion is disposed inside the first net-shaped portion.

10. The device for global remodeling of the aortic endoluminal structure and blood flow according to any one of claims 1 to 9, characterized in that: The sealing portion further includes at least two third tube portions disposed in the first tube portion, the adjacent third tube portions are disposed side by side, the third tube portions include a third mesh portion, and the third mesh portion has the second density.

11. The device for global remodeling of the aortic endoluminal structure and blood flow according to any one of claims 1 to 10, characterized in that: The main body further includes a partition extending along a length direction of the first tube portion, and the partition partition divides a portion of the first tube portion into two portions adjacent to each other.

12. A device for remodeling the aortic endoluminal structure and blood flow, characterized in that: The aortic intraluminal structure and blood flow global remodeling device includes a main body, the main body includes a first tube portion, the first tube portion includes a first mesh portion, the first mesh portion has a first density, the main body also includes a partition portion, the partition portion extends along the length direction of the first tube portion, the partition portion separates a portion of the first tube portion into two adjacent parts, and the first density is configured to enable the first mesh portion to pass liquid.

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