Stent, implant, delivery device and delivery system

Abstract

The invention provides a stent, an implant, a delivery device and a delivery system. A unit ring has deformability and can be in an expanded state or a contracted state based on the deformability; the multiple unit rings are sequentially connected in the axial direction of the unit rings to form the support. At least part of the unit rings are variable-axis ring bodies, and different ring side positions of the variable-axis ring bodies in the annular circumferential direction have different axial widths, so that different axial gap widths exist between different adjacent positions of the adjacent variable-axis ring bodies in the annular circumferential direction. Based on the structural design of the stent, the stent is adaptive to the bending structure of the ascending aorta after being implanted, after the stent is subjected to extrusion force applied to the stent by the ascending aorta, the large bending side and the small bending side of the stent are axially contracted to different degrees, the contraction degrees of the large bending side and the small bending side of the stent are different, and the difference is generated; this difference adapts to the lengths of the large and small curved sides of the ascending aorta, thereby adaptively solving the occurrence of beak phenomena.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to stents, implants, delivery devices, and delivery systems. Background Art

[0002] Aortic dissection refers to the blood flowing in the aortic lumen itself, which enters the media due to the rupture of the intima, causing separation of the aortic media and gradually expanding along the direction of the aortic blood vessel to form a vascular wall, resulting in a separated state of true and false lumens in the aorta. Aortic dissection is a disease that occurs frequently in the middle-aged and elderly population. After the disease becomes severe, it may be complicated by a series of cardiovascular problems such as arrhythmia and cardiac tamponade, affecting the life safety of patients. Aortic dissection is characterized by acute onset and high mortality, and has gradually become a cardiovascular disease that endangers human health. Surgical operation is an effective method for treating aortic dissection. For surgical thoracotomy, under deep hypothermic general anesthesia, extracorporeal circulation is carried out, and the aorta is clamped for 30 to 90 minutes, restricting blood flow to the brain and spinal cord, which has problems of high risk and high mortality. In case of advanced age, the general surgical effect is poor, and patients with other complications cannot tolerate this operation, and often have a long hospital stay and a long recovery period.

[0003] Minimally invasive endovascular treatment is to implant a covered stent through a delivery system to the lesion site. The covered stent has self-expanding properties and blood-blocking properties. After release, the covered stent can fit the true and false lumen blood vessels, prevent blood from entering the false lumen, and prevent the false lumen from expanding and rupturing. Due to different degrees of lesion involvement, when there is a tear in the aortic arch, the existing covered stents currently need to perform external fenestration or in-situ fenestration, with complex surgical operations, a high incidence of endoleak, and the covered stent is prone to poor adhesion to the blood vessel during the release process, resulting in the beak phenomenon and causing a risk of new dissection. Summary of the Invention

[0004] Based on this, it is necessary to provide a stent, an implant, a delivery device, and a delivery system for at least one of the above-mentioned technical problems.

[0005] This application provides a stent, which includes:

[0006] Unit rings, the unit rings have the ability to deform and can present an expanded state or a contracted state based on the deformation ability; the number of the unit rings is set to be several, and the several unit rings are connected in sequence along their axial directions to form the stent; wherein, at least part of the unit rings are variable-axis annular bodies, and different ring-side positions in the circumferential direction of the variable-axis annular body have different axial widths, so that there are different axial gap widths between different adjacent positions in the circumferential direction between adjacent variable-axis annular bodies.

[0007] In one embodiment, the circumferential ring side of the variable-axis ring body has a first ring side reference position and a second ring side reference position. The axial width of the first ring side reference position of the variable-axis ring body is the smallest, and the axial width of the second ring side reference position of the variable-axis ring body is the largest.

[0008] In one embodiment, along the direction from the first ring side reference position to the second ring side reference position, the axial width of the ring side of the variable-axis ring body in the circumferential direction gradually increases; and / or,

[0009] The first ring side reference position and the second ring side reference position are arranged on the radially symmetric two sides of the variable-axis ring body.

[0010] In one embodiment, the central position between the first ring side reference position and the second ring side reference position has a third ring side reference position. The circumferential direction of the variable-axis ring body has two radially symmetric third ring side reference positions. The axial width of the first ring side reference position is the first axial width, the axial width of the second ring side reference position is the second axial width, and the axial width of the third ring side reference position is the third axial width;

[0011] Wherein, the first axial width: the second axial width: the third axial width = 0.4 - 0.7: 1.4 - 1.6: 0.8 - 1.2.

[0012] In one embodiment, the variable-axis ring body includes a plurality of unit rods along its circumferential direction. At least some of the unit rods are inclined axially with respect to the variable-axis ring body, so that the plurality of unit rods are connected end to end in sequence along the circumferential direction of the variable-axis ring body to form the variable-axis ring body. At least some of the unit rods included in the variable-axis ring body have different rod lengths. The axial width at different ring side positions of the variable-axis ring body is the axial projection dimension of the unit rods at the different ring side positions of the variable-axis ring body; and / or,

[0013] Part of the unit rings located in the distal direction of the stent is the variable-axis ring body.

[0014] This application provides an implant, and the implant includes:

[0015] The stent;

[0016] A membrane, and the membrane is assembled on the surface of the stent body.

[0017] In one embodiment, the implant includes an adjusting wire, and the adjusting wire is connected to at least one variable-axis ring body of the stent, and the adjusting wire is connected to the ring side position with the smallest axial width of the variable-axis ring body; and / or,

[0018] The implant includes a protective film, the flexibility of the protective film being greater than that of the film, and the protective film is assembled outside the stent and the film; and / or,

[0019] The implant includes a developing element, and the developing element is disposed on the stent; and / or,

[0020] The material of the film is polyester; and / or,

[0021] The thickness of the film is between 0.05 mm and 2 mm; and / or, the film includes a main body region and a proximal covering region, the proximal covering region is used to cover the distal end of the stent, the thickness of the main body region of the film is 0.05 mm to 0.15 mm, and the thickness of the proximal covering region of the film is between 1 mm and 2 mm.

[0022] In one embodiment, the stent includes a distal stent segment, a middle stent segment, and a proximal stent segment along its axial direction, the film includes a first film segment and a second film segment, the first film segment is assembled on the distal stent segment, and the second film segment is assembled on the proximal stent segment; or,

[0023] The stent includes a distal stent segment, a middle stent segment, and a proximal stent segment along its axial direction, the film includes a first film segment, a second film segment, and a connecting film segment, the first film segment is assembled on the distal stent segment, the second film segment is assembled on the proximal stent segment, and the connecting film segment covers part of the middle stent segment.

[0024] This application provides a delivery device, and the delivery device includes:

[0025] An outer sheath tube, the inside of which has an axially penetrating sheath lumen;

[0026] An inner core tube, the inside of which has an axially penetrating core lumen, the inner core tube is movably disposed in the sheath lumen of the outer sheath tube, and the tube layer gap between the outer sheath tube and the inner core tube is used to accommodate the implant.

[0027] This application provides a delivery system, and the delivery system includes:

[0028] The implant; and the delivery device.

[0029] In the above-mentioned stent, implant, delivery device, and delivery system, based on the structural design of the stent itself, after the stent is implanted, it adapts to the bending structure of the ascending aorta. After the ascending aorta exerts a squeezing force on the stent, the large curvature side and the small curvature side of the stent itself undergo axial contractions to different degrees, and the contraction degrees of the large curvature side and the small curvature side of the stent are different, resulting in a difference. This difference adapts to the lengths of the large curvature side and the small curvature side of the ascending aorta, thereby adaptively solving the occurrence of the beak phenomenon. Description of the Drawings

[0030] Figure 1 This is a schematic structural view of an implant provided by an embodiment of the present application.

[0031] Figure 2 As shown in Figure 1 This is a schematic structural view of the stent of the implant shown.

[0032] Figure 3 As shown in Figure 2 This is a schematic structural view of the variable-axis ring body (unit ring) of the stent shown.

[0033] Figure 4 As shown in Figure 3 This is a schematic view of the first axial width, the second axial width, and the third axial width of the variable-axis ring body (unit ring) shown.

[0034] Figure 5 This is a schematic view of the state of the beak phenomenon generated after the implant provided by an embodiment of the present application is implanted.

[0035] Figure 6 This is a schematic view of the state of the implant provided by an embodiment of the present application without the beak phenomenon after implantation.

[0036] Figure 7 This is a schematic view of the implantation process of the implant provided by an embodiment of the present application.

[0037] Figure 8 This is a schematic view of the state of eliminating the beak phenomenon during the implantation process of the implant provided by an embodiment of the present application.

[0038] Figure 9 This is a schematic structural view of the delivery device provided by an embodiment of the present application.

[0039] Reference Numerals in the Drawings:

[0040] 100. Implant; 200. Delivery device;

[0041] 1000. Stent; 2000. Coating membrane; 3000. Adjusting wire;

[0042] 1100. Unit ring; 1200. Variable-axis ring body;

[0043] 1110. First ring-side reference position; 1120. Second ring-side reference position; 1130. Third ring-side reference position;

[0044] 1111. First axial width; 1121. Second axial width; 1131. Third axial width;

[0045] 1210, unit rod; 1211, axial width; 1212, axial clearance width;

[0046] 2100, first film segment; 2200, second film segment;

[0047] 210, outer sheath tube; 220, inner core tube; 230, traction wire. Detailed implementation manners

[0048] To make the above objects, features, and advantages of the present application more apparent and understandable, the following provides a detailed description of the specific implementation manners of the present application with reference to the accompanying drawings. Many specific details are set forth in the following description to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0049] In the description of the present application, it should be understood that if terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the accompanying drawings. These are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present application.

[0050] In addition, if terms such as "first" and "second" appear, these terms are only for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present application, if the term "plural" appears, the meaning of "plural" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0051] In the present application, unless otherwise clearly specified and limited, if terms such as "install", "connect", "couple", "fix", etc. appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0052] In this application, unless otherwise clearly specified and defined, when a first feature is described as being "on" or "under" a second feature or the like, it may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may mean that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature has a lower horizontal height than the second feature.

[0053] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or there may also be an intermediate element. If an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If so, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0054] To more clearly describe the stent, implant, delivery device and delivery system, the term "distal end" is hereby defined as the end far from the operator during the surgical operation, and the "proximal end" is defined as the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those commonly understood by those skilled in the technical field to which this application belongs. The terms used in the description of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0055] Referring to Figures 1 to 4 As shown, this application provides an implant 100, and the implant 100 includes a stent 1000 and a membrane 2000. The membrane 2000 is assembled on the surface of the frame body of the stent 1000, and thus a covered stent, that is, the above-mentioned implant 100, is jointly formed by the stent 1000 and the membrane 2000, as Figure 1 shown. Continuing to refer to Figures 1 to 4 As shown, the above-mentioned stent 1000 includes a unit ring 1100, and the unit ring 1100 has the ability to deform. For example, the unit ring 1100 can be made of a suitable memory metal, etc., and thus can have the above-mentioned deformation ability, so that the unit ring 1100 can be in an expanded state or a contracted state based on the deformation ability. Those skilled in the art can select the material, shape, size, etc. of the unit ring 1100 according to actual needs, so as to construct a suitable stent 1000 for the medical field, which is not limited herein.

[0056] Continuing to refer toFigure 1 and Figure 2 As shown in Figure 2 , the number of unit rings 1100 is set to several, and several unit rings 1100 are connected in sequence along their axial directions to form a bracket 1000. Therefore, the bracket 1000 composed of several unit rings 1100 can also be presented in an expanded state or a contracted state based on its deformation ability. Among them, several unit rings 1100 that make up the above-mentioned bracket 1000 can be unit rings 1100 of the same size and the same shape, so as to form a cylindrical bracket 1000 with the same position (same diameter) at different axial positions. Or, as Figure 1 and Figure 2 shown, in one embodiment, different unit rings 1100 of different axial frame segments that make up the bracket 1000 can also adopt different sizes, different shapes, etc., so as to form a cylindrical bracket 1000 with different structures at different axial positions or frame segments. Those skilled in the art can set the structure, shape, size, etc. of the bracket 1000 according to actual needs, which will not be limited here.

[0057] For example, in one embodiment, at least some or all of the unit rings 1100 among several unit rings 1100 are set as variable-axis ring bodies 1200. For example, as Figure 1 and Figure 2 shown, the frame segments of some unit rings 1100 located in the distal direction of the bracket 1000 are set as variable-axis ring bodies 1200. The variable-axis ring body 1200 can be defined as the structure shown in Figure 3 and Figure 4 , that is, different axial widths 1211 are provided at different ring-side positions in the circumferential direction of the variable-axis ring body 1200. The ring side refers to the side part of the ring body of the unit ring 1100. When several such variable-axis ring bodies 1200 are connected in sequence along the axial direction to form a partial frame segment of the bracket 1000, in this partial frame segment of the bracket 1000 formed by the variable-axis ring bodies 1200, different axial gap widths 1212 can be provided between different adjacent positions in the circumferential direction of adjacent variable-axis ring bodies 1200.

[0058] For example, in one embodiment, as Figure 3 and Figure 4 shown, the variable-axis ring body 1200 includes several unit rods 1210 along its circumferential direction. At least some of the unit rods 1210 are inclined relative to the axis of the variable-axis ring body 1200, so that several unit rods 1210 are connected end to end in sequence along the circumferential direction of the variable-axis ring body 1200 to form the variable-axis ring body 1200. At least some of the unit rods 1210 included in the variable-axis ring body 1200 have different rod lengths. The axial width 1211 at different ring-side positions of the variable-axis ring body 1200 is: the axial projection dimension of the unit rods 1210 at different ring-side positions of the variable-axis ring body 1200, that is, the projection dimension onto the plane where the axis of the bracket 1000 is located.​​​​

[0059] It can be seen from this that in the structural design of the above-mentioned stent 1000, at least part of the stent body segment of the stent 1000 can use the variable-axis ring body 1200 mentioned above as the unit ring 1100 and be connected in sequence in the axial direction of the stent 1000. When several variable-axis ring bodies 1200 are arranged along the axial direction of the stent 1000, in the part of the stent body segment of the stent 1000 formed by the variable-axis ring bodies 1200, different axial clearance widths 1212 will be formed between different adjacent positions in the circumferential direction between adjacent variable-axis ring bodies 1200.

[0060] The above structural design of the stent 1000 can be used to solve the beak phenomenon generated after the stent 1000 is implanted into the body. Refer to Figure 5 As shown, for the ascending aorta, the length of the major curvature side of the ascending aorta, the length of the center line of the ascending aorta, and the length of the minor curvature side of the ascending aorta are not the same. The length of the major curvature side of the ascending aorta is greater than the length of the minor curvature side of the ascending aorta, and the length of the center line of the ascending aorta is between the length of the major curvature side of the ascending aorta and the length of the minor curvature side of the ascending aorta. Therefore, due to the natural curved structure of the ascending aortic arch and the uncertain opening position relationship, especially for patients with a sharp curvature of the ascending aortic arch, it is very difficult for the stent 1000 to adhere well to the inner wall of the artery.

[0061] As Figure 5 shown, in the axial stent body segment of the stent 1000 from a1 to a2, which is the part of the stent 1000 corresponding to the minor curvature side of the ascending aorta, the axial stent body segment of the stent 1000 from b1 to b2, which is the part of the stent 1000 corresponding to the major curvature side of the ascending aorta, and the axial stent body segment of the stent 1000 from c1 to c2, which is the part of the stent 1000 corresponding to the center line of the ascending aorta. When the stent 1000 is implanted, it will bend towards the minor curvature side of the ascending aorta. Then, based on its deformation recovery ability, the axial stent body segment of the stent 1000 from b1 to b2 can adhere to the major curvature side of the ascending aorta. At this time, the length of the axial stent body segment of the stent 1000 from b1 to b2 is basically the length of the major curvature side of the ascending aorta. However, as Figure 5 shown, the axial stent body segment of the stent 1000 from a1 to a2 will tend to move away from the minor curvature side of the ascending aorta, resulting in a gap between the axial stent body segment of the stent 1000 from a1 to a2 and the minor curvature side of the ascending aorta, that is, the beak as Figure 5 shown. The phenomenon that there is a wedge-shaped gap between the stent 1000 and the wall of the ascending aorta due to the incomplete attachment of the distal end of the stent 1000, as Figure 5 shown, is called the "beak" effect.

[0062] To adapt to the natural curved structure of the ascending aortic arch and solve the above-mentioned beak phenomenon, based on the structural design of the stent 1000 mentioned above, the position of the ring side (side part) with a smaller axial clearance width 1212 of the stent 1000 can be corresponding to the position of the major curvature side of the ascending aorta. At this time, the position of the ring side (side part) with a smaller axial clearance width 1212 of the stent 1000 can also be referred to as the major curvature side of the stent 1000. The position of the ring side (side part) with a larger axial clearance width 1212 in the stent 1000 is corresponding to the position of the minor curvature side of the ascending aorta. At this time, the position of the ring side (side part) with a larger axial clearance width 1212 of the stent 1000 can also be referred to as the minor curvature side of the stent 1000.

[0063] When the stent 1000 is implanted into the ascending aorta and bends itself to adapt to the curved structure of the ascending aorta, on the minor curvature side of the ascending aorta, after the stent 1000 is subjected to the extrusion force of the ascending aorta, due to the larger axial clearance width 1212 of the stent 1000, it can contract to a greater extent in the axial direction, thereby greatly reducing the axial length of the part of the stent body segment corresponding to the minor curvature side of the ascending aorta in the stent 1000.

[0064] For example, refer to Figure 6 As shown, the axial stent body segment from a1 to a2 of the stent 1000 can contract in axial length after being stressed. Compared with Figure 5 the axial length of the stent 1000 from a1 to a2 in Figure 6 the axial length of the stent 1000 from a1 to a2 in Figure 6 can be greatly reduced, which can reduce the tendency of the distal end of the stent 1000 to recover towards the major curvature side of the ascending aorta to a certain extent, and then can be closer to the minor curvature side of the ascending aorta as shown in

[0065] The above method of solving the beak phenomenon is achieved based on the structural design of the stent 1000 itself, that is, after the stent 1000 is implanted, it adapts to the curved structure of the ascending aorta. After being subjected to the extrusion force exerted by the ascending aorta on the stent 1000, different degrees of axial contraction occur on the major curvature side and the minor curvature side of the stent 1000 itself, and the contraction degrees of the major curvature side and the minor curvature side of the stent 1000 are different, showing a difference. This difference adapts to the lengths of the major curvature side and the minor curvature side of the ascending aorta, thereby adaptively solving the occurrence of the beak phenomenon.

[0066] Regarding the structural design of the variable-axis ring body 1200, continue to refer to Figure 3 and Figure 4As shown, in one embodiment, a first circumferential reference position 1110 and a second circumferential reference position 1120 can be defined on the circumferential side of the variable-axis annular body 1200. The axial width 1211 of the first circumferential reference position 1110 of the variable-axis annular body 1200 is the smallest, and the axial width 1211 of the second circumferential reference position 1120 of the variable-axis annular body 1200 is the largest. At this time, the first circumferential reference position 1110 of the variable-axis annular body 1200 corresponds to the position of the minor curvature side of the ascending aorta, and the second circumferential reference position 1120 of the variable-axis annular body 1200 corresponds to the position of the major curvature side of the ascending aorta. In one embodiment, along the direction from the first circumferential reference position 1110 to the second circumferential reference position 1120, the axial width 1211 of the circumferential side of the variable-axis annular body 1200 can be defined to gradually increase, or the axial width 1211 of the circumferential side of the variable-axis annular body 1200 can be defined to increase in a stepped or other special design manner, for example, which is not limited herein.

[0067] The first circumferential reference position 1110 and the second circumferential reference position 1120 can be arranged on the radially symmetric two sides of the variable-axis annular body 1200, so that it can better correspond to the major curvature side and the minor curvature side of the ascending aorta. In addition, those skilled in the art can also set the radial positions of the first circumferential reference position 1110 and the second circumferential reference position 1120 on the variable-axis annular body 1200 according to the specific bending structure of the ascending aorta, so as to better correspond to the major curvature side and the minor curvature side of the ascending aorta, which is not limited herein.

[0068] Moreover, continuing to refer to Figure 3 As shown, in one embodiment, there is a third circumferential reference position 1130 at the central position between the first circumferential reference position 1110 and the second circumferential reference position 1120. There are two radially symmetric third circumferential reference positions 1130 on the circumferential direction of the variable-axis annular body 1200. The axial width 1211 of the first circumferential reference position 1110 is the first axial width 1111, the axial width 1211 of the second circumferential reference position 1120 is the second axial width 1121, and the axial width 1211 of the third circumferential reference position 1130 is the third axial width 1131.

[0069] The first axial width 1111: the second axial width 1121: the third axial width 1131 = 0.4 - 0.7: 1.4 - 1.6: 0.8 - 1.2. For example, the first axial width 1111: the second axial width 1121: the third axial width 1131 = 0.4: 1.4: 0.8, or the first axial width 1111: the second axial width 1121: the third axial width 1131 = 0.5: 1.5: 0.9, or the first axial width 1111: the second axial width 1121: the third axial width 1131 = 0.5: 1.5: 1, etc., which is not limited herein.

[0070] In addition, in one of the embodiments, the implant 100 may further include an adjusting wire 3000. The adjusting wire 3000 is connected to at least one variable-axis annular body 1200 of the stent 1000, and the adjusting wire 3000 is connected to the annular side position where the axial width 1211 of the variable-axis annular body 1200 is the smallest. Therefore, after the stent 1000 is implanted into the ascending aorta, if the beak phenomenon has not been completely eliminated based on the above structural design of the stent 1000, the adjusting wire 3000 can be pulled externally, so that the adjusting wire 3000 applies a pulling force to the distal end of the stent 1000 to pull it back, and the distal end of the stent 1000 is pressed against the small curvature side of the ascending aorta by using external force intervention, changing the shape of the stent 1000 and improving the poor wall attachment of the stent 1000, manually solving the beak phenomenon. The above manual adjustment method can be carried out after the beak phenomenon is solved by the structural design of the stent 1000, which belongs to secondary auxiliary adjustment, that is, assisting in manually solving the beak phenomenon, which can further eliminate the beak phenomenon and form a dual adjustment method of adaptive adjustment and manual adjustment.

[0071] Since the outer surface of the existing implant 100 (covered stent) is sharp, it is easy to damage the dissected intima during a relatively long life cycle. The implant 100 may also be provided with a protective film. The flexibility of the protective film is greater than that of the covering film 2000. The protective film is assembled outside the stent 1000 and the covering film 2000. The protective film can be made of a flexible polymer material. By adding a flexible polymer material to the outer surface of the implant 100 (covered stent), the flexible polymer material is made to fit the dissected intima, reducing the damage to the dissected intima at positions such as the metal and suture knots of the implant 100 (covered stent), and reducing the risk of new dissection or dissection rupture. Adding a flexible polymer material to the distal end of the implant 100 (covered stent) can have characteristics such as small pores and no blood leakage, which is beneficial to the long-term anastomosis of the covered stent and the blood vessel.

[0072] The implant may further include a developing element. The developing element is arranged on the stent. For example, the developing element can be arranged as one or more, and the developing element can be arranged at a suitable position such as the arch of the stent according to requirements, so that during the implantation process of the stent, the positioning of the stent is facilitated by the developing function of the developing element. Those skilled in the art can set the developing element at any suitable position on the stent according to actual needs, and no limitation is made here.

[0073] At least a part of the material of the film 2000 can be polyester, and the thickness of the film can be between 0.05 mm and 2 mm. For example, the thickness of the film is 0.1 mm, 0.2 mm, 0.3 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm. Among them, the film 2000 can be defined as including a connected main body area and a proximal covering area, and the main body area and the proximal covering area together constitute the whole of the film 2000.

[0074] The proximal covering area is used to cover the proximal end of the stent 1000. Therefore, the proportion of the area of the proximal covering area in the film 2000 can be designed according to the actual needs of covering the proximal end of the stent 1000, and no limitation is made here. At this time, the thickness of the proximal covering area of the film 2000 can be defined between 1 mm and 2 mm. The thickness of 1 mm to 2 mm can make the film 2000 easier to suture, and the thickness range of this proximal covering area will not cause blood leakage at the needle hole when threading the film 2000. In contrast, the thickness of the main body area of the film 2000 can be defined as 0.05 mm to 0.15 mm.

[0075] Refer to Figure 6 As shown, in one embodiment, the stent 1000 includes a distal stent segment, a middle stent segment, and a proximal stent segment along its axial direction, and the middle stent segment is located between the distal stent segment and the proximal stent segment. At this time, the film 2000 includes a first film segment 2100 and a second film segment 2200. The first film segment 2100 is assembled on the distal stent segment, and the second film segment 2200 is assembled on the proximal stent segment. The middle stent segment in the middle is not covered by the film 2000, thereby making the implant 100 form a structure with half film and half bare segment. The half film formed by the first film segment 2100 and the second film segment 2200 can be used to block the aortic arch dissection, and the half bare segment (that is, the bare middle stent segment not covered by the film 2000) between the first film segment 2100 and the second film segment 2200 can ensure the smooth blood flow of the aortic arch branches.

[0076] The film 2000 can also include a connecting film segment connecting the first film segment 2100 and the second film segment 2200, and the connecting film segment covers a part of the middle stent segment. That is, on the basis that the first film segment 2100 is assembled on the distal stent segment and the second film segment 2200 is assembled on the proximal stent segment, the middle stent segment of the stent 1000 can also be covered by the connecting film segment of the film 2000 on a part of the surface.

[0077] For example, the small curvature side of the middle frame segment is covered with the film 2000, while the large curvature side of the middle frame segment remains exposed without being covered by the film 2000. This is a partial circumferential film covering design for the middle frame segment of the stent 1000. At this time, the small curvature side of the middle frame segment of the stent 1000 is covered by the film 2000, which can effectively block the rupture or ulcer on the small curvature side of the aortic arch and prevent the rupture of the false lumen. The large curvature side of the middle frame segment of the stent 1000 remains exposed without being covered by the film 2000, so it does not affect the blood supply of the three branches of the aortic arch.

[0078] Those skilled in the art can design the surface area covered by the film 2000 and the surface area not covered by the film 2000 for the middle frame segment of the stent 1000 according to actual needs, so as to meet the technical problems such as the blood supply of the three branches and the blocking of the rupture or ulcer on the small curvature side, which will not be limited here.

[0079] Refer to Figures 7 to 9 As shown, the present application provides a delivery device 200. The delivery device 200 includes an outer sheath 210, an inner core tube 220, a guiding wire and a traction wire 230. The inside of the outer sheath 210 has an axially penetrating sheath lumen, and the inside of the inner core tube 220 has an axially penetrating core lumen. The inner core tube 220 is movably inserted into the sheath lumen of the outer sheath 210. The tube layer gap between the outer sheath 210 and the inner core tube 220 is used to accommodate the implant 100. The guiding wire is movably inserted into the core lumen of the inner core tube 220. The guiding wire can form a guiding trajectory for the inner core tube 220 to be implanted into the target position in the body, so that the inner core tube 220 and the entire delivery device 200 are accurately implanted into the target position in the body along the guiding wire.

[0080] The traction wire 230 can apply a retraction force to the implant 100 by retracting, which is used to pull the distal end of the implant 100 in the proximal direction. By using external force intervention, the distal end of the stent 1000 is pressed against the small curvature side of the ascending aorta, changing the shape of the stent 1000 and improving the poor apposition of the stent 1000, and manually solving the beak phenomenon.

[0081] The present application provides a delivery system, which includes the above-mentioned implant 100 and the delivery device 200. Since the specific structures, functional principles and technical effects of the above-mentioned implant 100 and the delivery device 200 have been described in detail above, they will not be elaborated here. Any technical content regarding the above-mentioned implant 100 and the delivery device 200 can refer to the previous records.

[0082] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0083] The above-described embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all fall within the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A bracket, characterized in that, The stent includes: Unit rings, which have the ability to deform and can present an expanded state or a contracted state based on the deformation ability; the number of the unit rings is set to be several, and the several unit rings are connected in sequence along their axial directions to form the stent; wherein, at least part of the unit rings are variable-axis ring bodies, and different ring-side positions in the circumferential direction of the variable-axis ring body have different axial widths, so that there are different axial clearance widths between different adjacent positions in the circumferential direction between adjacent variable-axis ring bodies.

2. The bracket according to claim 1, wherein, The circumferential direction of the ring side of the variable-axis ring body has a first ring-side reference position and a second ring-side reference position, the axial width of the first ring-side reference position of the variable-axis ring body is the smallest, and the axial width of the second ring-side reference position of the variable-axis ring body is the largest.

3. The bracket according to claim 2, characterized in that, Along the direction from the first ring-side reference position to the second ring-side reference position, the axial width of the ring side in the circumferential direction of the variable-axis ring body gradually increases; and / or, The first ring-side reference position and the second ring-side reference position are arranged on the radially symmetric two sides of the variable-axis ring body.

4. The bracket according to claim 3, characterized in that, There is a third ring-side reference position at the central position between the first ring-side reference position and the second ring-side reference position. The circumferential direction of the variable-axis ring body has two radially symmetric third ring-side reference positions. The axial width of the first ring-side reference position is the first axial width, the axial width of the second ring-side reference position is the second axial width, and the axial width of the third ring-side reference position is the third axial width; wherein, the first axial width: the second axial width: the third axial width = 0.4 - 0.7:1.4 - 1.6:0.8 - 1.

2.

5. The bracket according to claim 1, characterized in that, The variable-axis ring body includes several unit rods along its circumferential direction. At least part of the unit rods are inclined relative to the axial direction of the variable-axis ring body, so that the several unit rods are connected end to end in sequence along the circumferential direction of the variable-axis ring body to form the variable-axis ring body. At least part of the unit rods included in the variable-axis ring body have different rod lengths, and the axial width of different ring-side positions of the variable-axis ring body is the axial projection dimension of the unit rods at different ring-side positions of the variable-axis ring body; and / or, part of the unit rings in the distal direction of the stent are the variable-axis ring bodies.

6. An implant, characterized in that, The implant includes: The stent according to any one of claims 1 - 5; A film, which is assembled on the surface of the frame body of the stent.

7. The implant according to claim 6, wherein, The implant includes an adjusting wire, the adjusting wire is connected to at least one variable-axis ring body of the stent, and the adjusting wire is connected to the ring-side position with the smallest axial width of the variable-axis ring body; and / or, The implant includes a protective film, the flexibility of the protective film is greater than that of the film, and the protective film is assembled outside the stent and the film; and / or, The implant includes a developing element, and the developing element is arranged on the stent; and / or, The material of the film is polyester; and / or, The thickness of the film is between 0.05 mm and 2 mm; and / or, The film covering includes a main body region and a proximal covering region. The proximal covering region is used to cover the distal end of the stent. The thickness of the main body region of the film covering is 0.05 mm to 0.15 mm, and the thickness of the proximal covering region of the film covering is between 1 mm and 2 mm.

8. The implant according to claim 6, wherein The stent includes a distal stent segment, a middle stent segment, and a proximal stent segment along its axis. The film covering includes a first film segment and a second film segment. The first film segment is assembled on the distal stent segment, and the second film segment is assembled on the proximal stent segment; or The stent includes a distal stent segment, a middle stent segment, and a proximal stent segment along its axis. The film covering includes a first film segment, a second film segment, and a connecting film segment. The first film segment is assembled on the distal stent segment, the second film segment is assembled on the proximal stent segment, and the connecting film segment covers a part of the middle stent segment.

9. A conveying device, characterized in that, The delivery device includes: An outer sheath tube having an axially through sheath lumen inside; An inner core tube having an axially through core lumen inside. The inner core tube is movably inserted into the sheath lumen of the outer sheath tube. The tube layer gap between the outer sheath tube and the inner core tube is used to accommodate the implant as described in any one of claims 6 to 8.

10. A conveying system, characterized in that, The delivery system includes: The implant as described in any one of claims 6 to 8; and The delivery device as described in claim 9.

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