Medical implant, medical system and use method of medical system

Abstract

The invention provides a medical implant, a medical system and a use method thereof, the medical implant comprises a first covered stent and a barb assembly, the first covered stent comprises a first stent body, a second stent body and a first positioning piece which are sequentially arranged in the direction from the near end to the far end; the first covered stent further comprises a first covering film, and the first covering film covers the first stent body, the second stent body and the near-end part of the first positioning piece; the first covering film is further provided with a first preset position and a second preset position, the first preset position and the second preset position are located between the first stent body and the second stent body, and the first preset position and the second preset position are staggered; the first preset position is used for forming a first window, the second preset position is used for arranging a barb assembly, and the barb assembly comprises barbs. The medical implant is applied to treatment of DeBakey II-type aortic dissection with a tearing opening appearing between a coronary artery opening and the junction of a sinus canal and / or a dissection section extending towards the coronary artery opening, and the first support body is used for providing radial force for the ascending aorta wall for anchoring; in addition, the barbs penetrate into the ascending aorta wall to provide anchoring force and resist blood flow impact, so that the first stent body is allowed to provide relatively small radial force, stimulation to the ascending aorta wall is reduced, and the occurrence rate of stent-derived new crevasses caused by the stimulation of the radial force is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a medical implant, a medical system and a method of using the same. Background Art

[0002] DeBakey type II aortic dissection occurs in the ascending aorta and its extension is limited to the ascending aorta. Traditionally, surgical procedures have involved artificial blood vessel transplantation, with Bentall and Cabrol procedures being common.

[0003] With the development of interventional technology, the application of total endovascular repair has been improved. In the existing technology, most of the composite stents used for DeBakey II type aortic dissection are of one-piece structure, and these one-piece composite stents are basically considered for cases where the dissection segment is located in the ascending aorta, and the dissection tear is located between the sinus-tubular junction and the brachiocephalic artery, without involving the coronary artery and aortic valve. However, in fact, many DeBakey II type aortic dissection tears appear between the coronary artery ostium and the sinus-tubular junction, and / or the dissection segment extends to the coronary artery ostium, resulting in involvement of the coronary artery ostium and obstruction of the coronary artery.

[0004] In addition, the existing one-piece composite stent is anchored by radial force. The problem with this type of design is that if the radial force is too large, although it has good stent anchoring performance, it will stimulate the aortic wall too much, which may easily cause new stent-induced ruptures; if the radial force is too small, it will cause the stent to fit loosely with the aortic wall, resulting in internal leakage. Summary of the Invention

[0005] The present invention aims to provide a medical implant, a medical system, and a method of use thereof for treating DeBakey type II aortic dissection in which the tear occurs between the coronary artery ostium and the sinus-tubular junction and / or the dissection segment extends toward the coronary artery ostium, thereby reducing irritation to the vessel wall and thereby lowering the incidence of new stent-induced ruptures.

[0006] To achieve the above-mentioned object, the present invention provides a medical implant comprising a first stent graft and a barb assembly; wherein:

[0007] The first stent graft comprises a first stent body, a second stent body and a first positioning member arranged in sequence from the proximal end to the distal end; the first stent graft further comprises a first coating, the first coating covering the first stent body, the second stent body and the proximal end portion of the first positioning member; the first coating has a first predetermined position and a second predetermined position, the first predetermined position and the second predetermined position are both located between the first stent body and the second stent body, and the first predetermined position and the second predetermined position are staggered with each other; the first predetermined position is used to form a first window;

[0008] The barb assembly includes a plurality of barbs, and the barb assembly is capable of being disposed at the second predetermined position.

[0009] Optionally, the first stent body includes a plurality of stent rings sequentially arranged along the axial direction of the first stent graft; each stent ring includes a crest, a trough, and a stem portion, the crests and troughs are alternately arranged in the circumferential direction of the first stent graft, and each stem portion is located between a crest and a trough and connects the corresponding crest and trough;

[0010] A plurality of folded portions are formed on a portion of the first graft located at the first stent body, each of the folded portions extending along the circumference of the first graft stent, and the plurality of folded portions are arranged in an imbricate manner along the axial direction of the first graft stent;

[0011] The first covering film is connected to at least a portion of the stem portion of each stent ring, and each folded portion is located at a crest or trough of at least one stent ring and is pressed against the crest or trough of the corresponding stent ring.

[0012] Optionally, two adjacent stent rings partially overlap in the axial direction of the first covering; the first covering forms a folded portion at the overlapping position of the two adjacent stent rings;

[0013] The wave crest of one of the two adjacent support rings and the wave trough of the other one are respectively pressed against the opposite sides of the corresponding folded portion.

[0014] Optionally, the second predetermined position is used to form a second window; the barb assembly also includes a base, on which the barbs are arranged; the base can be arranged at the second window and connected to the portion of the first coating located on the periphery of the second window.

[0015] Optionally, the medical implant also includes a second coated stent, which includes a third stent body and a second coating covered on the third stent body; the proximal end of the second coating protrudes from the proximal end of the third stent body, or the distal end of the second coating protrudes from the distal end of the third stent body; the end of the second coating protruding from the third stent body can be connected to the first coated stent, and the second coated stent is set at the first predetermined position and connected to the first coated stent through the first window.

[0016] Optionally, the medical implant further comprises a third coated stent, the outer diameter of the proximal end of the third coated stent being larger than the inner diameter of the third stent body; the proximal end of the third coated stent can be inserted into the second coated stent and have an interference fit with the third stent body.

[0017] Optionally, the medical implant also includes a valve prosthesis, which includes a main body stent, and the outer diameter of the proximal end of the main body stent is larger than the inner diameter of the second stent body; the valve prosthesis can be partially inserted into the first coated stent, and the proximal end of the main body stent is interference fit with the second stent body.

[0018] Optionally, the first positioning member includes at least three sub-positioning members sequentially connected end to end along the circumference of the first stent graft;

[0019] The valve prosthesis also includes second positioning members, and the number of the second positioning members is the same as the number of the sub-positioning members; a plurality of the second positioning members are arranged at a position near the distal end of the main body stent and are arranged along the circumference of the main body stent; when the valve prosthesis is partially inserted into the first coated stent, each second positioning member can be connected to one of the first positioning members.

[0020] Optionally, each of the sub-positioning members is formed with an engagement hole, and the engagement hole is at least partially located at the distal end side of the first covering film;

[0021] When the valve prosthesis is partially disposed in the first stent graft, each of the second positioning members can at least partially pass through one of the engagement holes.

[0022] To achieve the above-mentioned object, the present invention further provides a medical system comprising a medical implant and a delivery assembly; wherein,

[0023] The medical implant comprises:

[0024] The first stent graft comprises a first stent body, a second stent body, and a first positioning member arranged in sequence from the proximal end to the distal end; the first stent graft further comprises a first coating, the first coating covering the first stent body, the second stent body, and the proximal end portion of the first positioning member; the first coating has a first predetermined position and a second predetermined position, the first predetermined position and the second predetermined position are both located between the first stent body and the second stent body, and the first predetermined position and the second predetermined position are staggered with each other; the first predetermined position is used to form a first window;

[0025] a barb assembly comprising a plurality of barbs, wherein the barb assembly is capable of being disposed at the second predetermined position;

[0026] a second stent graft, capable of being connected to the first fenestration of the first stent graft;

[0027] Valve prosthesis, including main stent;

[0028] third stent graft;

[0029] The conveying assembly comprises:

[0030] a first conveyor configured to load and convey the medical implant and the barb assembly and the second stent graft connected to the first stent graft, release the proximal end of the first stent graft, the barb assembly, and the second stent graft at a first target location, release the distal end of the first stent graft at a second target location, and allow the barbs to penetrate the wall of the first target location;

[0031] a second conveyor for loading and conveying the valve prosthesis and releasing the valve prosthesis to the second target location, so that the valve prosthesis is partially disposed in the lumen of the first stent graft and the second stent body is clamped at the proximal end of the main stent;

[0032] The third conveyor is used to load and convey the third coated stent, release the proximal end of the third coated stent into the inner cavity of the second coated stent, release the distal end of the third coated stent at a third target position, and make the second coated stent at least partially clamped on the proximal end of the third coated stent.

[0033] To achieve the above objectives, the present invention further provides a method for using the aforementioned medical system, comprising:

[0034] The proximal end of the first stent graft, the barb assembly connected to the first stent graft, and the second stent graft are conveyed and released to a first target location using the first conveyor, and the barbs are inserted into the wall of the first target location, and the distal end of the first stent graft is conveyed and released to a second target location;

[0035] Using the second conveyor to deliver and release the valve prosthesis to the second target position, so that the valve prosthesis is partially disposed in the inner cavity of the first stent graft and the second stent body is clamped at the proximal end of the main stent; and

[0036] The proximal end of the third coated stent is transported and released into the inner cavity of the second coated stent by the third transporter, and the distal end of the third coated stent is transported and released at a third target position, so that the second coated stent is at least partially clamped on the proximal end of the third coated stent.

[0037] Compared with the prior art, the medical implant and medical system of the present invention have the following advantages:

[0038] The aforementioned medical implant includes a first coated stent and a barb assembly, the first coated stent includes a first stent body, a second stent body and a first positioning member arranged in sequence from the proximal end to the distal end; the first coated stent also includes a first coating, the first coating covers the first stent body, the second stent body and the proximal part of the first positioning member; the first coating also has a first predetermined position and a second predetermined position, the first predetermined position and the second predetermined position are both between the first stent body and the second stent body, and the first predetermined position is used to form a first window, the second predetermined position is used to set the barb assembly, and the barb assembly includes barbs. The medical implant is used to treat DeBakey II type aortic dissection in which the tear occurs between the coronary artery ostium and the junction of the sinus tube, and / or the dissection segment extends toward the coronary artery ostium, and the first covered stent is used to be implanted in the ascending aorta segment and also extends to the aortic sinus. While using the first stent body to provide radial force to the ascending aorta wall for anchoring, it also provides further anchoring force and resists blood flow impact by providing the barb assembly to use the barbs to pierce the ascending aorta wall. This allows the first stent body to provide a relatively small radial force, thereby effectively reducing stimulation to the ascending aorta wall, and thereby reducing the incidence of new stent-induced ruptures caused by radial force stimulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The accompanying drawings are provided for a better understanding of the present invention and are not intended to limit the present invention.

[0040] Figure 1is a schematic diagram of the overall structure of a medical implant provided according to one embodiment of the present invention;

[0041] Figure 2 1 is a schematic structural diagram of a first stent graft of a medical implant provided according to an embodiment of the present invention, wherein two adjacent first stent rings in the figure are in the same phase;

[0042] Figure 3 1 is a schematic structural diagram of a first stent graft of a medical implant according to an embodiment of the present invention, wherein the phase difference between two adjacent first stent rings is 180°;

[0043] Figure 4 1 is a schematic structural diagram of a barb assembly of a medical implant provided according to one embodiment of the present invention;

[0044] Figure 5 1 is a schematic structural diagram of a first coating of a first coated stent of a medical implant provided according to one embodiment of the present invention;

[0045] Figure 6 1 is a schematic diagram of a first stent graft of a medical implant provided by an embodiment of the present invention being connected to a first conveyor;

[0046] Figure 7 1 is a schematic structural diagram of a second stent graft of a medical implant provided according to one embodiment of the present invention;

[0047] Figure 8 1 is a partial structural diagram of a medical implant provided according to one embodiment of the present invention, in which a first stent graft is connected to a barb assembly and a second stent graft, and the second stent graft is disposed in the inner cavity of the first stent graft;

[0048] Figure 9 1 is a partial structural diagram of a medical implant provided according to one embodiment of the present invention, in which a first stent graft is connected to a barb assembly and a second stent graft, and the second stent graft is disposed outside the first stent graft;

[0049] Figure 10 1 is a schematic structural diagram of a valve prosthesis of a medical implant provided according to one embodiment of the present invention;

[0050] Figure 11 1 is a schematic diagram of an application scenario of a medical implant provided according to an embodiment of the present invention, showing that a first stent graft, a barb assembly, and a second stent graft of the medical implant have been implanted in the body;

[0051] Figure 12is a schematic diagram of an application scenario of a medical implant provided according to an embodiment of the present invention, showing the operation of delivering and partially releasing a valve prosthesis using a second delivery device;

[0052] Figure 13 1 is a schematic diagram of an application scenario of a medical implant provided according to an embodiment of the present invention, showing that a first stent graft, a barb assembly, a second stent graft, and a valve prosthesis of the medical implant have been implanted in a body;

[0053] Figure 14 Schematic diagram of an application scenario of a medical implant provided according to an embodiment of the present invention, showing that the medical implant has been completely implanted into the body.

[0054] [Description of reference numerals is as follows]:

[0055] 1000 - first stent graft, 1100 - first stent body, 1110 - first stent ring, 1111 - first wave crest, 1112 - first wave trough, 1113 - first rod, 1200 - second stent body, 1210 - second stent ring, 1211 - second wave crest, 1212 - second wave trough, 1213 - second rod, 1300 - first positioning member, 1310 - base, 1311 - joint Hole, 1312-stent rod, 1400-first coating, 1401-first window, 1410-folding part, 2000-barb assembly, 2100-barb, 2200-base, 3000-third coated stent, 4000-valve prosthesis, 4100-main stent, 4200-second positioning piece, 5000-second coated stent, 5100-third stent body, 5200-second coating. DETAILED DESCRIPTION

[0056] The following describes the embodiments of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner, and the drawings only show components related to the present invention rather than being drawn according to the number, shape and size of components during actual implementation. During actual implementation, the type, quantity and proportion of each component can be changed at will, and the component layout type may also be more complicated.

[0057] In addition, each embodiment described below has one or more technical features. However, this does not mean that users of the present invention must implement all technical features in any embodiment at the same time, or that they can only implement some or all technical features in different embodiments separately. In other words, as long as implementation is possible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0058] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be internal communication between two elements or an interactive relationship between two elements. Relational terms such as "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly indicate the number of technical features indicated. It should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "up," "down," "front," "back," "left," "right," "vertical," "horizontal," "top," "bottom," "inside," "outside," "axial," "radial," "circumferential," and the like, indicating positions or location relationships, are based on the positions or location relationships shown in the accompanying drawings and are intended only to facilitate description and simplify the description of the present invention. They do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be construed as limiting the present invention. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0059] The terms "proximal end" and "distal end" as used herein describe the relative positions and orientations of the various components and parts of a medical device during normal use. Although non-limiting, "proximal end" generally refers to the end of the medical device that is closest to the operator during normal operation, while "distal end" generally refers to the end of the medical device that is farther away from the operator during normal operation.

[0060] The present invention aims to provide a medical implant that is designed to effectively treat DeBakey type II aortic dissection in which the tear occurs between the coronary artery ostium and the sinus-tubular junction and / or the dissection segment extends toward the coronary artery ostium, while also reducing irritation to the ascending aorta wall by the medical implant and lowering the likelihood of stent-induced new ruptures.

[0061] To make the objects, advantages, and features of the present invention more apparent, the present invention is further described below in detail with reference to the accompanying drawings. It should be noted that the drawings are greatly simplified and not to exact scale, and are intended solely to facilitate and clearly illustrate the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0062] Figure 1 The overall structure diagram of the medical implant provided by one embodiment of the present invention is shown in FIG. Figure 1 The medical implant includes at least a first stent graft 1000 and a barb assembly 2000 .

[0063] Please continue to refer to Figure 1 and combined Figures 2 to 4 , the first coated stent 1000 includes a first stent body 1100, a second stent body 1200, a first positioning member 1300, and a first coating 1400. The first stent body 1100, the second stent body 1200 and the first positioning member 1300 are arranged in sequence from the proximal end to the distal end. The first coating 1400 extends from the proximal end of the first stent body 1100 to the middle of the first positioning member 1300, and is covered on the proximal end of the first stent body 1100, the second stent body 1200 and the first positioning member 1300, so that the distal end of the first positioning member 1300 is divided into a bare section. The first coating 1400 also has a first predetermined position (not marked in the figure) and a second predetermined position (not marked in the figure), and the first predetermined position and the second predetermined position are both located between the first stent body 1100 and the second stent body 1200, and the first predetermined position and the second predetermined position are staggered with each other. The first predetermined position is used to form a first window 1401" (such as Figure 8 As shown), the second predetermined position is used to set the barb assembly 2000, and the barb assembly 2000 includes a plurality of barbs 2100.

[0064] When the medical implant is used to treat DeBakey II type aortic dissection in which the tear appears between the coronary artery ostium and the junction of the sinus tube, and / or the dissection segment extends toward the coronary artery ostium, the proximal portion of the first coated stent 1000 is used to be implanted into the ascending aorta, and the first positioning member 1300 at its distal end is used to be inserted into the aortic sinus, and the first fenestration 1401 is arranged toward the coronary artery ostium, thereby allowing the first coating 1400 to fully isolate the dissecting blood flow, and utilizing the first fenestration 1401 to provide a path for coronary artery blood perfusion. During anchoring, the first stent body 1100 is used to provide radial anchoring force to the ascending aorta wall, and at the same time, the barb 2100 is also inserted into the ascending aorta wall to utilize the interaction between the barb 2100 and the ascending aorta wall to provide a part of the anchoring force, thereby realizing the anchoring of the first coated stent 1000. This makes the radial force provided by the first stent body 1100 relatively small, so as to reduce the stimulation to the ascending aorta wall and achieve the effect of reducing the incidence of new stent-induced ruptures.

[0065] It can be understood that the number of the first predetermined positions is two, so that a first window 1401 is formed at each first predetermined position, wherein one of the first windows 1401 is used to face the left coronary artery ostium to provide a path for blood perfusion of the left coronary artery, and the other first window 1401 is used to face the right coronary artery ostium to provide a path for blood perfusion of the right coronary artery. Moreover, when the barb assembly 2000 is set at the second predetermined position, the free end of the barb 2100 extends from the distal end to the proximal end of the first coated stent 1000, so that the barb 2000 can resist the impact force of the blood flow and increase its penetration depth into the ascending aorta wall under the action of the blood flow impact force without falling out of the blood vessel wall.

[0066] In practice, the barb assembly 2000 also includes a base 2200, on which the barbs 2100 are provided. In some embodiments, the base 2200 directly covers the portion of the first coating 1400 located at the second predetermined position, and is connected to the first coating 1400 by suturing, bonding, or any other suitable means. In other embodiments, the second predetermined position is used to form a second window, and the base 2200 is used to cover the second window, and is also connected to the portion of the first coating 1400 located at the periphery of the second window by suturing, bonding, or any other suitable means. The advantage of doing this is that when the first coating stent 1000 and the barb assembly 2100 thereon are squeezed and gripped, the outer diameter of the medical implant at the second predetermined position can be reduced, thereby reducing the resistance during its delivery. The material of the base 2200 should be flexible and stable, such as polyester or polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE), etc. The barbs 2100 can be made of nickel-titanium alloy.

[0067] It should be noted that the first predetermined position and the second predetermined position are both determined during the operation based on the patient's CT angiography results. Specifically, the patient's left coronary artery ostium, right coronary artery ostium, and the position of the ascending aorta wall without dissection are determined based on the CT angiography results, and two first predetermined positions corresponding to the left coronary artery ostium and the right coronary artery ostium are determined respectively based on the left coronary artery ostium and the right coronary artery ostium, and at least one second predetermined position is determined based on the position of the ascending aorta wall without dissection. In other words, the first stent graft 1000 and the barb assembly 2000 are split structures before the operation, and the two are connected as one during the operation.

[0068] Furthermore, the middle portion of the first positioning member 1300 refers to any suitable position between the proximal and distal ends of the first positioning member 1300. Thus, the first coating 1400 extending to the middle portion of the first positioning member 1300 means that the distal end of the first coating 1400 is between the proximal and distal ends of the first positioning member 1300. Thus, the first stent body 1100, the second stent body 1200, and the proximal portion of the first positioning member 1300 are covered by the first coating 1400 over their entire axial length, while the distal portion of the first positioning member 1300 is not covered by the first coating 1400 and remains a bare section.

[0069] Here, the first coating 1400 is covered on the first bracket body 1100, the second bracket body 1200 and part of the first positioning member 1300, which includes both the situation that the first coating 1400 is attached to the outer surface of the first bracket body 1100, the second bracket body 1200 and part of the first positioning member 1300, and the situation that the first coating 1400 is attached to both the outer surface of the first bracket body 1100, the second bracket body 1200 and part of the first positioning member 1300 and the inner surface of the first bracket body 1100, the second bracket body 1200 and part of the first positioning member 1300.

[0070] Optionally, the first stent body 1100 includes a plurality of first stent rings 1110 sequentially arranged along the axial direction of the first stent graft 1000. Each first stent ring 1110 includes a first wave crest 1111, a first wave trough 1112, and a first rod portion 1113. The first wave crests 1111 and the first wave troughs 1112 are alternately arranged in the circumferential direction of the first stent graft 1000. Each first rod portion 1113 is disposed between one of the first wave crests 1111 and one of the first wave troughs 1112, and connects the corresponding first wave crest 1111 and the first wave trough 1112.

[0071] The first covering 1400 is fixedly connected to at least a portion of the first rod portion 1113 of each first stent ring 1110 by suturing, bonding, welding or any other appropriate means. Figure 5As shown, a plurality of folding portions 1410 are formed on the portion of the first stent body 1100 of the first coating 1400 by folding, and the plurality of folding portions 1410 are arranged along the axial direction of the first coating stent 1000. Each fold formed by the folding extends continuously along the circumference of the first coating stent 1000, so that each folding portion 1410 extends continuously along the circumference of the first coating stent 1000 to form a closed annular structure in the circumferential direction of the first coating stent 1000. Two adjacent folding portions 1410 partially overlap in the axial direction of the first coating stent 1000, so that all the folding portions 1410 are arranged in a shingled manner in the axial direction of the first coating stent 1000. The reason for this arrangement is that the portion of the ascending aorta adjacent to the aortic arch is curved, with the radius of curvature of the greater curvature side being greater than the radius of curvature of the lesser curvature side. After the plurality of folding portions 1410 arranged in an imbricate manner are provided, when the first stent graft 1000 is released into the body, the region of at least one of the folding portions 1410 located on the greater curvature side can at least partially unfold under the action of the curved vascular wall of the ascending aorta and conform to the shape of the ascending aorta, and better fit to the ascending aorta wall. Here, the "greater curvature side" refers to the side of the ascending aorta close to the branch arteries such as the innominate artery when viewed from the circumference of the ascending aorta, and can also be regarded as the convex side of the ascending aorta; the "lesser curvature side" refers to the side of the ascending aorta away from the branch arteries such as the innominate artery when viewed from the circumference of the ascending aorta, and can also be regarded as the concave side of the ascending aorta.

[0072] Each of the folding portions 1410 is located at least at the first wave crest 1111 or the first wave trough 1112 of one of the first stent rings 1110 and is pressed against the first wave crest 1111 or the first wave trough 1112 of the corresponding first stent ring 1110 to prevent the folding portion 1410 from dispersing before the first coated stent 1000 is released into the body.

[0073] Preferably, two adjacent first stent rings 1110 partially overlap in the axial direction of the first stent graft 1000, and each folded portion 1410 is formed at the overlapping position of the two adjacent first stent rings 1110. That is, each folded portion 1410 is formed at the location of the first wave crest 1111 of one of the two adjacent first stent rings 1110 and the location of the first wave trough 1112 of the other. In this case, each folded portion 1410 can be pressed against by the first wave crest 1111 of one of the two corresponding adjacent first stent rings 1110 and the first wave trough 1112 of the other, thereby more effectively preventing the folded portion 1410 from dispersing before the first stent graft 000 is released into the body. It should be understood that the first wave peak 1111 of one of the two adjacent first support rings 1110 and the first wave valley 1112 of the other are respectively pressed against the inner and outer sides of the corresponding folding portion 1410, so that the folding portion 1410 is clamped by the two adjacent first support rings 1110.

[0074] Additionally, in some embodiments, Figure 2 As shown, all the first stent rings 1110 have the same phase, so that the first wave crests 1111 of all the first stent rings 1110 are aligned in the circumferential direction of the first stent graft 1000, and the first wave troughs 1112 of all the first stent rings 1110 are aligned in the circumferential direction of the first stent graft 1000. In other embodiments, two adjacent first stent rings 1110 have different phases, for example, Figure 3 As shown, each of the first stent rings 1110 includes an odd number of peaks and an odd number of troughs, and the phase difference between two adjacent first stent rings 1110 is 180°, so that the first peaks 1111 of two adjacent first stent rings 1110 are staggered in the circumferential direction of the first coated stent 1000, and the first troughs 1112 of two adjacent first stent rings 1110 are staggered in the circumferential direction of the first coated stent 1000.

[0075] In an embodiment of the present invention, the first stent ring 1110 can be made of nickel-titanium wire. Furthermore, the radial force provided by the first stent ring 1110 can be varied by adjusting the thickness of the nickel-titanium wire and the number and shape of the first wave crests 1111 and first wave troughs 1112 on the first stent ring 1110. The material of the first coating 1400 should have good flexibility and stability. Optional materials include, but are not limited to, polyester, polytetrafluoroethylene (PTFE), and expanded polytetrafluoroethylene (ePTFE).

[0076] Optionally, the configuration of the second bracket body 1200 may be similar to the configuration of the first bracket body 1100. Figures 1 to 3 As shown, the second stent body 1200 includes a plurality of second stent rings 1210 arranged in sequence along the axial direction of the first coated stent 1000. Each second stent ring 1210 includes a second wave crest 1211, a second wave trough 1212, and a second rod portion 1213. The second wave crests 1211 and the second wave troughs 1212 are alternately arranged in the circumferential direction of the first coated stent 1000. Each second rod portion 1213 is located between a second wave crest 1211 and a second wave trough 1212, and connects the corresponding second wave crest 1211 and second wave trough 1212. The phases of two adjacent second stent rings 1210 can be the same or different.

[0077] The second stent ring 1210 can also be made of nickel-titanium wire. Furthermore, the radial force provided by the second stent ring 1210 can be varied by adjusting the thickness of the nickel-titanium wire and the number and shape of the second wave crests 1211 and second wave troughs 1212 on the second stent ring 1210. The first coating 1400 can be fixedly connected to any position of the second stent ring 1210.

[0078] Optionally, the first positioning member 1300 includes at least three sub-positioning members 1310 connected end-to-end along the circumference of the first stent graft. Some of the sub-positioning members 1310 are used for insertion into the left aortic sinus, others are used for insertion into the right aortic sinus, and still others are used for insertion into the posterior aortic sinus. In practice, the number of sub-positioning members 1310 can be three.

[0079] During application, the first stent graft 1000 together with the barb assembly 2000 thereon is delivered through the first delivery device 10 and released into the body. Figure 6 As shown, the first positioning member 1300 is also used to connect to the first conveyor 10. In an optional embodiment, the first conveyor 10 is provided with a plurality of hooks 11, the number of the hooks 11 being equal to the number of the sub-positioning members 1310, and the plurality of hooks 1310 are arranged in the circumferential direction of the first conveyor 10. The sub-positioning members 1310 are formed with engagement holes 1311, which are partially located on the distal side of the first coating 1400. When the first coating stent 1000 is pressed and gripped on the first conveyor 10, each hook 11 can partially pass through the engagement hole 1311 and hook on the corresponding sub-positioning member 1310.

[0080] In an exemplary embodiment, each of the bases 1310 includes two V-shaped support rods 1311, and the material of each of the support rods 1311 can be nickel-titanium alloy. The two support rods 1312 of the same base 1310 are arranged relative to each other along the axial direction of the first coated stent 1000 and are connected to each other, and enclose the coupling hole 1311. Specifically, the two support rods 1311 are respectively referred to as the first support rod (not marked in the figure) and the second support rod (not marked in the figure), and the first support rod and the second support rod are arranged in the direction from the proximal end to the distal end of the first coated stent 1000. The open end of the first support rod faces the distal end of the first coated stent 1000, and the open end of the second support rod faces the proximal end of the first coated stent 1000, and the open end of the first support rod coincides with the open end of the second support rod, so that the first support rod and the second support rod enclose the diamond-shaped coupling hole 1311. It is understood that the support rod 1311 has a corner portion, and the corner portion is arranged opposite to the open end. As an example, the corner portion of the support rod 1311 is formed into a rounded corner.

[0081] The distal end of the first covering film 1400 may extend to the intersection of the first support rod and the second support rod, so that the distal end portion of the engagement hole 1311 is located on the distal side of the first covering film 1400. When connected to the first conveyor 10, each hook 11 partially passes through the corresponding engagement hole 1311 and is hooked on the corresponding second support rod.

[0082] The inner diameter of the ascending aorta of patients with DeBakey type II aortic dissection typically decreases from proximal to distal. Therefore, the outer diameter of the portion of the first stent graft 1000 located between the proximal end of the first stent body 1100 and the proximal end of the second stent body 1200 also decreases from proximal to distal to accommodate the morphology of the patient's ascending aorta. The outer diameter of the portion of the first stent graft 1000 located between the proximal end of the second stent body 1200 and the distal end of the first positioning member 1300 can remain constant.

[0083] Those skilled in the art will understand that Figure 1As shown, the first stent graft 1000 should be used in combination with the third stent graft 3000 and the valve prosthesis 4000 to treat DeBakey type II aortic dissection. The third stent graft 3000 is used to pass through the first fenestration and be partially implanted in the coronary artery to serve as a blood perfusion channel for the coronary artery. The valve prosthesis 4000 is used to cooperate with the distal end of the first stent graft 1000 and be anchored on the second stent body 1200 to replace the native aortic valve and prevent blood from impacting the dissection at the native aortic valve. In an optional embodiment, the medical implant may include the third stent graft 3000 and the valve prosthesis 4000. The first stent graft 1000, the third stent graft 3000 and the valve prosthesis 4000 are separate structures before surgery, and the three are combined together after implantation in the body.

[0084] Furthermore, if Figure 1 and Figures 7 to 9 As shown, the medical implant further includes a second stent graft 5000, which can be connected at the first predetermined position and communicates with the inner lumen of the first stent graft 1000 through the first fenestration 1401. The third stent graft 3000 is partially implanted in the coronary artery via the second stent graft 5000 and the first fenestration.

[0085] As mentioned above, the first predetermined position is determined during the operation, that is, the second coated stent 5000 and the first coated stent 1000 are separate structures before the operation, and the two are combined into one during the operation.

[0086] Optionally, the second stent graft 5000 includes a third stent body 5100 and a second graft 5200, wherein the second graft 5200 is coated on the third stent body 5100. The second graft 5200 may be attached to the outer surface of the third stent body 5100, or the second graft 5200 may be attached to both the inner surface and the outer surface of the third stent body 5100.

[0087] The second stent graft 5000 can be disposed in the inner cavity of the first stent graft 1000 or outside the first stent graft 1000. Regardless of the relative position and orientation of the second stent graft 5000 and the first stent graft 1000, the second stent graft 5000 should be flexibly connected to the first stent graft 1000, so that the second stent graft 5000 has a certain degree of freedom of movement relative to the first stent graft 1000.

[0088] In some embodiments, the distal end of the second stent graft 5200 protrudes from the distal end of the third stent body 5100, and the distal end of the second stent graft 5200 is used to be connected to the first stent graft 1000 by bonding, suturing, or any other suitable means, and the second stent graft 5000 is disposed in the inner lumen of the first stent graft 1000. In this case, by adjusting the orientation of the second stent graft 5000 so that the axis of the second stent graft 5000 is not perpendicular to the axis of the first stent graft 1000, blood can be ensured to be perfused into the coronary arteries, thereby avoiding poor perfusion of the coronary arteries during surgery, while also facilitating the implantation of the third stent graft 3000. In other embodiments, the proximal end of the second stent graft 5200 protrudes from the proximal end of the third stent body 5100, and the proximal end of the second stent graft 5200 is used to be connected to the first stent graft 1000 by bonding, suturing, or any other suitable means, and the second stent graft 5000 is disposed outside the first stent graft 1000. In this way, before the third stent graft 300 is implanted, a certain space is provided between the outer wall of the second stent graft 5000 and the blood vessel wall, which does not block the coronary artery ostium and thus prevents the problem of poor coronary perfusion during surgery.

[0089] It should be understood that the second stent graft 5000 is connected to the first stent graft 1000 when outside the body. The second stent graft 5000, the first stent graft 1000 and the barb assembly 2000 are delivered and released into the body via the first delivery device 10.

[0090] It should be noted that the third stent body 5100 includes at least one third stent ring (not marked in the figure), and the configuration of the third stent ring may be similar to that of the first stent ring 1110 and the second stent ring 1210, and specifically includes a third wave crest, a third wave trough and a third rod portion (not marked in the figure), the third wave crest and the third wave trough are alternately arranged along the circumference of the second coated stent 5000, and each of the third rod portions is located between a third wave crest and a third wave trough, and connects the corresponding third wave crest and the third wave trough. The third stent ring can be obtained by bending nickel-titanium wire. The second coating 5200 can be made of polyester or polytetrafluoroethylene or expanded polytetrafluoroethylene, and the second coating 5200 can be fixedly connected to any position of the third stent ring.

[0091] After the first stent graft 1000 and the barb assembly 2000 thereon, and the second stent graft 5000 are implanted into the body using the first conveyor 10, a conveyor different from the first conveyor 10 (i.e., the third conveyor described later) is used to convey the third stent graft 3000 and partially release it into the coronary artery. Moreover, when the third stent graft 3000 is partially implanted into the coronary artery, the distal end of the third stent graft 5000 is inserted into the second stent graft 5000. Preferably, the outer diameter of the proximal end of the third stent graft 3000 is greater than the inner diameter of the third stent body 5100. Thus, when the proximal end of the third stent graft 3000 is inserted into the second stent graft 5000 and at least partially overlaps with the third stent body 5100, the third stent graft 3000 and the third stent body 5100 have an interference fit. That is, the third stent body 5100 can clamp the proximal end of the third stent graft 3000 so that the third stent graft 3000 is anchored in the body.

[0092] The present embodiment does not specifically limit the structure of the third stent graft 3000. The third stent graft 3000 may be any conventional stent graft suitable for coronary artery implantation, including but not limited to the Gore-Viabvahn VBX stent and the Bard-Fluency stent. The third stent graft 3000 generally has an outer diameter of 5 mm to 7 mm and an axial length of 15 mm to 70 mm.

[0093] Please refer to Figure 10 The valve prosthesis 4000 includes a main stent 4100 and a plurality of second positioning members 4200. When the valve prosthesis 4000 is implanted in the body and blood flows through the valve prosthesis 4000, the blood flows from the distal end to the proximal end of the main stent 4100 (that is, the distal end of the main stent 4100 constitutes the inflow end of the main stent 4100, and the proximal end of the main stent 4100 constitutes the outflow end of the main stent 4100). The plurality of second positioning members 4200 are disposed near the distal end of the main stent 4100, and the plurality of second positioning members 4200 are arranged along the circumference of the main stent 4100.

[0094] The valve prosthesis 4000 is used to be delivered and released into the body using a conveyor different from the first conveyor 10 (i.e., the second conveyor described below) after the first stent graft 1000, the barb assembly 2000 thereon, and the second stent graft 5000 are implanted in the body. The outer diameter of the proximal end of the main stent body 4100 is greater than the inner diameter of the second stent body 1200. When the valve prosthesis 4000 is implanted in the body, a part of the second positioning member 4200 is inserted into the left aortic sinus, another part of the second positioning member 4200 is inserted into the right aortic sinus, and another part of the second positioning member 4300 is inserted into the posterior aortic sinus to achieve the positioning of the valve prosthesis 4000. At the same time, the valve prosthesis 4100 is partially penetrated into the first coated stent 1000, and the proximal end of the main stent 4100 is at least partially overlapped with the second stent body 1200, and the proximal end of the main stent 4100 is interference fit with the second stent body 1200, so that the second stent body 1200 is used to clamp the main stent 4100, thereby improving the anchoring performance of the valve prosthesis 4000.

[0095] Further preferably, a plurality of the second positioning members 4200 are also connected to the first positioning member 1300 to further improve the anchoring performance of the valve prosthesis 4000 .

[0096] In detail, the number of the second positioning members 4200 is equal to the number of the sub-positioning members 1310, and when the valve prosthesis 4000 is implanted in the body, each of the second positioning members 4200 is at least partially inserted into the coupling hole 1311 of one of the sub-positioning members 1310 to achieve the connection between the second positioning member 4200 and the first positioning member 1300.

[0097] The embodiment of the present invention does not specifically limit the detailed structure of the valve prosthesis 4000, as long as it includes the main frame 4100 and the positioning member 4200. Optional valve prostheses 4000 include, but are not limited to, the JenaValve valve prosthesis known in the art. Furthermore, the outer diameter of the valve prosthesis 4000 is generally 23 mm to 30 mm.

[0098] The use process of the medical implant provided by the embodiment of the present invention includes:

[0099] Step S10: First, the first stent graft 1000, the barb assembly 2000 and the second stent graft 5000 are connected as one.

[0100] Step S20, use the first conveyor 10 to load and convey the first coated stent 1000 and the barb assembly 2000 and the second coated stent 5000 thereon, and release the proximal end of the first coated stent 1000, the barb assembly 2000, and the second coated stent 5000 into the first target position, and release the distal end of the first coated stent 1000 into the second target position, and allow the barb 2100 to penetrate the wall of the first target position.

[0101] Step S30: Use a second conveyor (not shown in the figure) to load and convey the valve prosthesis 4000, release the valve prosthesis 4000 into the second target position, and clamp the second stent body 1200 of the first coated stent 1000 on the proximal end of the main stent 4100 of the valve prosthesis 4000.

[0102] Step S40: Use a third conveyor to load and convey the third coated stent 3000, release the proximal end of the third coated stent 3000 into the second coated stent 5000, release the distal end of the third coated stent 3000 into a third target position, and make the second coated stent 5000 at least partially clamped on the proximal end of the third coated stent 3000.

[0103] In a real surgical scenario, the first target location is the ascending aorta, the second target location is the aortic sinus (including the left aortic sinus, the right aortic sinus, and the posterior aortic sinus), and the third target location is the coronary artery (including the left and right coronary arteries). In a simulated surgical procedure, the first target location is the ascending aorta model in the human tissue model, the second target location is the aortic sinus model (including the left aortic sinus model, the right aortic sinus model, and the posterior aortic sinus model), and the third target location is the coronary artery model (including the left and right coronary artery models).

[0104] Figures 11 to 14 The diagram shows the implantation process of the medical implant after the first stent graft 1000, the barb assembly 2000 and the second stent graft 5000 are connected as one.

[0105] Taking a real surgical scenario as an example, and combining Figures 11 to 14, step S20 specifically includes: using the first conveyor 10 to convey the first stent graft 1000 and the barb assembly 2000 thereon, and the second stent graft 5000 into the body. Then, first ensure the relative position of the first positioning member 1300 and the left aortic sinus, the right aortic sinus and the posterior aortic sinus, then partially release the first stent graft 1000, and then pull the first conveyor 10 so that the barb 2100 penetrates the ascending aorta wall, and finally release the other parts of the first stent graft 1000, and release the connection between the first conveyor 10 and the first stent graft 1000. After this step is completed, the state of the medical implant in the body is as follows: Figure 11 As shown, Figure 11 The second stent graft 5000 is arranged in the inner cavity of the first stent graft 1000.

[0106] Step S30 specifically includes using the second delivery device to deliver the valve prosthesis 4000 into the body, then releasing all the second positioning members 4200, and inserting each of the second positioning members 4200 into the corresponding engaging hole 1311, so that the second positioning member 4200 is partially located between the first positioning member 1300 and the native aortic valve leaflet (not shown in the figure), and then adjusting the height of all the second positioning members 4200 so that each of the second positioning members 4200 is inserted into the sinus floor (such as the left aortic sinus, the right aortic sinus, and the posterior aortic sinus) of the corresponding aortic sinus. Figure 12 Finally, the rest of the valve prosthesis 4000 is released. After this step is completed, the state of the medical implant in the body is as follows. Figure 13 shown.

[0107] Step S40 specifically includes using the third conveyor to transport the third coated stent 3000 into the body via the first coated stent 1000, the second coated stent 5000 and the first window, and making a part of the third coated stent 5000 located in the coronary artery and the other part located in the second coated stent 5000, and then releasing the third coated stent 3000.

[0108] It should be understood that, in practice, step S30 is performed once for the left coronary artery to partially implant one third stent graft 3000 into the left coronary artery, and step S30 is performed once for the right coronary artery to partially implant another third stent graft 3000 into the right coronary artery. After performing step S30 twice, the state of the medical implant in the body is as follows: Figure 14 shown.

[0109] Furthermore, embodiments of the present invention provide a medical system comprising the first stent graft 1000, the barb assembly 2000, the second stent graft 5000, the third stent graft 3000, the valve prosthesis 4000, the first conveyor 10, the second conveyor, and the third conveyor. The specific structures and coordination of the various components of the medical system are described above and will not be repeated here.

[0110] While the present invention is disclosed above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to encompass such modifications and variations as long as they fall within the scope of the claims and their equivalents.

Claims

1. A medical implant, characterized in that It comprises a first stent graft and a barb assembly; wherein: The first stent graft comprises a first stent body, a second stent body and a first positioning member arranged in sequence from the proximal end to the distal end; the first stent graft further comprises a first coating, the first coating covering the first stent body, the second stent body and the proximal end portion of the first positioning member; the first coating has a first predetermined position and a second predetermined position, the first predetermined position and the second predetermined position are both located between the first stent body and the second stent body, and the first predetermined position and the second predetermined position are staggered with each other; the first predetermined position is used to form a first window; The barb assembly includes a plurality of barbs, and the barb assembly is capable of being disposed at the second predetermined position.

2. The medical implant according to claim 1, wherein The first stent body includes a plurality of stent rings arranged in sequence along the axial direction of the first stent graft; each stent ring includes a crest, a trough, and a stem portion, the crests and troughs being alternately arranged in the circumferential direction of the first stent graft, and each stem portion is located between a crest and a trough and connects the corresponding crest and trough; A plurality of folded portions are formed on a portion of the first graft located at the first stent body, each of the folded portions extending along the circumference of the first graft stent, and the plurality of folded portions are arranged in an imbricate manner along the axial direction of the first graft stent; The first covering film is connected to at least a portion of the stem portion of each stent ring, and each folded portion is located at a crest or trough of at least one stent ring and is pressed against the crest or trough of the corresponding stent ring.

3. The medical implant according to claim 2, characterized in that The two adjacent stent rings partially overlap in the axial direction of the first covering; the first covering forms a folded portion at the overlapping position of the two adjacent stent rings; The wave crest of one of the two adjacent support rings and the wave trough of the other one are respectively pressed against the opposite sides of the corresponding folded portion.

4. The medical implant according to claim 1, wherein The second predetermined position is used to form a second window; the barb assembly also includes a base, on which the barbs are arranged; the base can be arranged at the second window and connected to the portion of the first coating located at the periphery of the second window.

5. The medical implant according to claim 1, wherein The medical implant also includes a second coated stent, which includes a third stent body and a second coating covered on the third stent body; the proximal end of the second coating protrudes from the proximal end of the third stent body, or the distal end of the second coating protrudes from the distal end of the third stent body; the end of the second coating protruding from the third stent body can be connected to the first coated stent, and the second coated stent is set at the first predetermined position and connected to the first coated stent through the first window.

6. The medical implant according to claim 5, characterized in that The medical implant further includes a third stent graft, the outer diameter of the proximal end of the third stent graft is larger than the inner diameter of the third stent body; the proximal end of the third stent graft can be inserted into the second stent graft and has an interference fit with the third stent body.

7. The medical implant according to claim 1, wherein The medical implant also includes a valve prosthesis, which includes a main body stent, and the outer diameter of the proximal end of the main body stent is larger than the inner diameter of the second stent body; the valve prosthesis can be partially inserted into the first coated stent, and the proximal end of the main body stent is interference fit with the second stent body.

8. The medical implant according to claim 7, characterized in that The first positioning member includes at least three sub-positioning members connected end to end in sequence along the circumference of the first stent graft; The valve prosthesis also includes second positioning members, and the number of the second positioning members is the same as the number of the sub-positioning members; a plurality of the second positioning members are arranged at a position near the distal end of the main body stent and are arranged along the circumference of the main body stent; when the valve prosthesis is partially inserted into the first coated stent, each second positioning member can be connected to one of the first positioning members.

9. The medical implant according to claim 8, characterized in that An engagement hole is formed on each of the sub-positioning members, and the engagement hole is at least partially located on the distal end side of the first covering film; When the valve prosthesis is partially disposed in the first stent graft, each of the second positioning members can at least partially pass through one of the engagement holes.

10. A medical system, characterized in that: Comprising medical implants and delivery assemblies; wherein, The medical implant comprises: The first stent graft comprises a first stent body, a second stent body, and a first positioning member arranged in sequence from the proximal end to the distal end; the first stent graft further comprises a first coating, the first coating covering the first stent body, the second stent body, and the proximal end portion of the first positioning member; the first coating has a first predetermined position and a second predetermined position, the first predetermined position and the second predetermined position are both located between the first stent body and the second stent body, and the first predetermined position and the second predetermined position are staggered with each other; the first predetermined position is used to form a first window; a barb assembly comprising a plurality of barbs, wherein the barb assembly is capable of being disposed at the second predetermined position; a second stent graft, capable of being connected to the first fenestration of the first stent graft; Valve prosthesis, including main stent; third stent graft; The conveying assembly comprises: a first conveyor configured to load and convey the medical implant and the barb assembly and the second stent graft connected to the first stent graft, release the proximal end of the first stent graft, the barb assembly, and the second stent graft at a first target location, release the distal end of the first stent graft at a second target location, and allow the barbs to penetrate the wall of the first target location; a second conveyor for loading and conveying the valve prosthesis and releasing the valve prosthesis to the second target location, so that the valve prosthesis is partially disposed in the lumen of the first stent graft and the second stent body is clamped at the proximal end of the main stent; The third conveyor is used to load and convey the third coated stent, release the proximal end of the third coated stent into the inner cavity of the second coated stent, release the distal end of the third coated stent at a third target position, and make the second coated stent at least partially clamped at the proximal end of the third coated stent.

11. The method for using the medical system according to claim 10, wherein: include: The proximal end of the first stent graft, the barb assembly connected to the first stent graft, and the second stent graft are conveyed and released to a first target location using the first conveyor, and the barbs are inserted into the wall of the first target location, and the distal end of the first stent graft is conveyed and released to a second target location; Using the second conveyor to deliver and release the valve prosthesis to the second target position, so that the valve prosthesis is partially disposed in the inner cavity of the first stent graft and the second stent body is clamped at the proximal end of the main stent; and The proximal end of the third coated stent is transported and released into the inner cavity of the second coated stent by the third transporter, and the distal end of the third coated stent is transported and released at a third target position, so that the second coated stent is at least partially clamped on the proximal end of the third coated stent.

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