Delivery device and delivery system

Abstract

The application relates to a delivery device, a catheter assembly comprising an inner core tube and an outer sheath tube, the inner core tube movably assembled in the sheath lumen of the outer sheath tube, a constriction lumen being formed between the outer wall of the inner core tube and the inner wall of the outer sheath tube, the constriction lumen being used for constraining a stent graft, and an adjusting assembly comprising an adjusting wire, the adjusting wire movably arranged in the constriction lumen between the inner core tube and the outer sheath tube and used for detachably connecting with the distal end area of the small-curved side of the stent graft. A surgeon pulls the adjusting wire outside the organism to adjust the position of the distal end area of the small-curved side of the stent graft. During the adjustment, the large-curved side of the stent graft remains unchanged, the small-curved side of the stent graft deviates by a certain angle towards the proximal end, and the surgeon can judge whether the small-curved side of the stent graft is adjusted to the expected shape under the assistance of DSA imaging and other auxiliary means, so that the distal end area of the small-curved side of the stent graft finally forms a good endosial effect and the "bird beak" phenomenon is solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a delivery device and a delivery system. BACKGROUND

[0002] Aortic dissection is caused by various reasons, which leads to the tearing of the aortic intima, the blood flows into the arterial wall, and the vascular lumen is divided into true and false lumens by the free intimal flap. The blood flow inlet on the aortic intimal flap is the primary rupture. The dissection involving the ascending aorta is the Standford A type dissection. The dissection involving the left subclavian artery and its distal thoracic descending aorta is the Standford B type dissection.

[0003] For Standford A type dissection, open surgery is the current gold standard. Compared with surgery, endovascular treatment has the characteristics of small incision, less bleeding, less pain, faster recovery, and no need to stop circulation. For high-risk patients, elderly patients, Standford A type dissection patients in emergency situations, and patients who refuse surgery, endovascular treatment of ascending aortic lesions can be considered.

[0004] The ascending aorta is more curved than the descending aorta. When the proximal end of the conventional stent graft does not adhere well to the proximal end of the ascending aorta, the "beak" phenomenon will occur, which will cause type Ia endoleak, displacement, and proximal new rupture and aneurysmal dilatation. Moreover, this position is close to the left ventricle, and it may also cause blood reflux, thereby causing aortic valve insufficiency and increased cardiac load and other adverse events. Therefore, endovascular treatment requires the stent graft to have good adhesion performance. The ascending aorta is subjected to high-speed blood flow impact from the left ventricle, and the proximal end is close to the coronary artery and the distal end is close to the head and arm trunk artery, so the precise positioning performance of the stent graft is required. SUMMARY

[0005] Therefore, it is necessary to provide a delivery device for the technical problem of the "beak" phenomenon caused by poor adhesion of the stent graft.

[0006] The present application provides a delivery device, which comprises:

[0007] A catheter assembly, which comprises an inner core tube and an outer sheath tube, the inner core tube is movably assembled in the sheath lumen of the outer sheath tube, and a constriction shaft lumen is constructed between the outer wall of the inner core tube and the inner wall of the outer sheath tube, which is used to constrict the stent graft;

[0008] An adjusting assembly, which comprises an adjusting wire body, the adjusting wire body is arranged in the constriction shaft lumen and detachably connected with the distal end region of the small curved side of the stent graft.

[0009] In one of the embodiments, the adjusting assembly further comprises:

[0010] a connecting element arranged at the distal end region of the small-curve side of the stent graft, and the distal end of the adjusting wire body is detachably connected with the connecting element.

[0011] In one of the embodiments, the adjusting assembly further comprises:

[0012] a constraint element movably arranged in the convergence shaft cavity, and the adjusting wire body is detachably connected with the connecting element through the constraint element.

[0013] In one of the embodiments, the connecting element has a first constraint hole and a second constraint hole, the adjusting wire body passes through the first constraint hole, the constraint element passes through the second constraint hole, and the distal end of the constraint element is connected with the distal end of the adjusting wire body for limiting the distal end of the adjusting wire body from being separated from the connecting element; and / or,

[0014] the distal end of the constraint element has a tapering structure gradually tapering from the proximal end to the distal end.

[0015] In one of the embodiments, the distal end of the adjusting wire body has a constraint coil, at least a part of the constraint coil passes through the first constraint hole, and the distal end of the constraint element sequentially passes through the second constraint hole and the constraint coil for limiting the distal end of the adjusting wire body from being separated from the connecting element; and / or,

[0016] the first constraint hole is a circular hole, and the hole inner diameter of the first constraint hole is at least twice greater than the wire body diameter of the adjusting wire body.

[0017] In one of the embodiments, the adjusting assembly further comprises:

[0018] a first binding element arranged along the axial direction of the stent graft at the small-curve side of the stent graft, so that the adjusting wire body is arranged along the axial direction of the small-curve side of the stent graft; and / or,

[0019] a second binding element arranged along the axial direction of the stent graft at the small-curve side of the stent graft, so that the constraint element is arranged along the axial direction of the small-curve side of the stent graft.

[0020] In one of the embodiments, the number of the first binding elements is multiple, all the first binding elements are arranged along the axial direction of the stent graft at the small-curve side of the stent graft, the distance between the connecting element and the farthest first binding element is L1, and the coil length of the constraint coil is L2, wherein 2L1 is less than or equal to L2; and / or,

[0021] The number of the connecting elements and the number of the adjusting wire bodies are both plural, all the connecting elements are arranged at different circumferential positions of the distal end region of the small-curved side of the stent graft, and each adjusting wire body is detachably connected with at least one connecting element.

[0022] In one of the embodiments, the distal end of the inner core tube is detachably connected with the distal end region of the large-curved side of the stent graft.

[0023] In one of the embodiments, the catheter assembly further comprises:

[0024] a guide element arranged at the distal end of the inner core tube;

[0025] a release wire body movably arranged in the converging shaft cavity, and used for detachably connecting the distal end region of the large-curved side of the stent graft with the guide element.

[0026] In one of the embodiments, the catheter assembly further comprises:

[0027] a guide frame body having a first assembly channel and a second assembly channel, the inner core tube is arranged in the first assembly channel, and the release wire body is arranged in the second assembly channel, and the distal end of the release wire body is used for passing through the stent bare segment of the stent graft and connecting with the guide element.

[0028] The present application provides a delivery system, which comprises the delivery device and a stent graft, and the delivery device is used for delivering the stent graft.

[0029] In the delivery device, the proximal end of the adjusting wire body is pulled, the adjusting wire body can apply a pulling force to the distal end region of the small-curved side of the stent graft along the axial direction of the stent graft, and the position of the distal end region of the small-curved side of the stent graft is adjusted by the pulling force. During the adjustment process, the large-curved side of the stent graft remains unchanged, the small-curved side of the stent graft deviates a certain angle towards the proximal end, and the surgeon can determine whether the small-curved side of the stent graft is adjusted to the expected shape under the assistance of DSA imaging and other auxiliary means, so as to finally make the distal end region of the small-curved side of the stent graft form a good endosseous effect and solve the “beak” phenomenon. Moreover, during the adjustment process of the stent graft by the adjusting assembly, only the adjusting assembly needs to be controlled to realize the adjustment of the stent graft, which not only can realize a stable and controllable adjustment, but also can ensure that the stent graft is stably positioned at the target position during the release and adjustment process and does not shift. BRIEF DESCRIPTION OF DRAWINGS

[0030] Figures 1 to 6 The figure shows a schematic diagram of the use process of the delivery device provided by one of the embodiments of the present application.

[0031] Figure 7 and Figure 8 Figure 6 shows a comparison of the stent graft in the adjusted state by the delivery device according to an embodiment of the present application.

[0032] Figure 9 Figure 7 shows an assembly structure diagram of the adjustment assembly according to an embodiment of the present application.

[0033] Figure 10 Figure 8 shows an enlarged structure diagram of the adjustment assembly. Figure 9

[0034] Figure 9 shows a plan structure diagram of the adjustment assembly according to an embodiment of the present application. Figure 11

[0035] Figure 10 shows a structure diagram of the adjustment wire according to an embodiment of the present application. Figure 12

[0036] Figure 11 shows an assembly structure diagram of the adjustment assembly according to another embodiment of the present application. Figure 13

[0037] Figure 12 shows an arrangement structure diagram of the first binding element and the second binding element according to an embodiment of the present application. Figure 14

[0038] Figure 13 shows a partial structure diagram of the catheter assembly according to an embodiment of the present application. Figure 15

[0039] Figure 14 shows a cross-sectional diagram of the catheter assembly. Figure 16 Figure 15 Figure 15 shows a cross-sectional diagram of the catheter assembly.

[0040] Reference signs:

[0041] 100, stent graft; 200, guide wire;

[0042] 1000, catheter assembly; 2000, adjustment assembly;

[0043] 1100, inner core tube; 1200, outer sheath tube;

[0044] 1300, guide element; 1400, release wire; 1500, guide frame body;

[0045] 1500a, first assembly channel; 1500b, second assembly channel;

[0046] 2100, adjustment wire; 2200, connecting element; 2300, constraint element; 2400, first binding element; 2500, second binding element;

[0047] ​2200a, first constraint hole; 2200b, second constraint hole;

[0048] 2100a, constraint coil. DETAILED DESCRIPTION

[0049] In order to make the above objectives, features and advantages of the present application more clear and easy to understand, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the accompanying drawings can be arranged and designed in various different configurations; in order to make the structure more intuitive, some structure in the present application is not in actual proportion. In the following description, a lot of specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be implemented in many different ways than those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, therefore the present application is not limited to the specific embodiments disclosed below.

[0050] In the description of the present application, it should be understood that if these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0051] In addition, if these terms "first", "second" appear, these terms are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features limited by "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, if the term "multiple" appears, the meaning of "multiple" is at least two, for example, two, three, etc., unless otherwise specifically limited.

[0052] In the present application, unless specifically defined otherwise, if there is an appearance of the terms "mount", "connect", "connection", "fixed", and the like, these terms should be broadly understood. For example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise specifically defined. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0053] In the present application, unless specifically defined otherwise, if there is a similar description of the first feature "on" or "under" the second feature, it can mean that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature "above", "above" and "above" the second feature can be the first feature directly above or obliquely above the second feature, or only indicates that the first feature is higher than the second feature in horizontal height. The first feature "below", "below" and "below" the second feature can be the first feature directly below or obliquely below the second feature, or only indicates that the first feature is lower than the second feature in horizontal height.

[0054] It should be noted that if an element is referred to as "fixed to" or "provided to" another element, it can be directly on another element or there can be a middle element. If an element is considered to be "connected" to another element, it can be directly connected to another element or there can be a middle element. If present, the terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used in the present application are only for illustrative purposes and do not represent the only implementation.

[0055] In order to more clearly describe the structure of the delivery device, the term "distal end" herein means the end away from the operator during the operation, and the "proximal end" means the end close to the operator during the operation. Unless otherwise defined, all technical and scientific terms used in the present application have the same meaning as understood by those skilled in the art to which the present application belongs. The terms used in the specification of the present application are only for the purpose of describing the specific embodiments and are not intended to limit the present application.

[0056] Moreover, the "large bending side" of the blood vessel in the present application refers to the side with a larger radius of curvature of the blood vessel, and the "small bending side" of the blood vessel refers to the side with a smaller radius of curvature of the blood vessel. The "large bending side" and "small bending side" of the stent graft 100 represent the shape and position of the stent graft 100 after bending in the blood vessel, which is consistent with the blood vessel.

[0057] Referring to Figures 1 to 16As shown, an embodiment of the present application provides a delivery device. The delivery device can include a catheter assembly 1000 and an adjustment assembly 2000 (as shown in Figure 9 and Figure 10 ). The catheter assembly 1000 includes an inner core tube 1100 (as shown in Figure 15 ) and an outer sheath tube 1200, the inner core tube 1100 is movably fitted in the sheath lumen of the outer sheath tube 1200, and a guide wire 200 can be movably arranged in the core lumen of the inner core tube 1100. The outer wall of the inner core tube 1100 and the inner wall of the outer sheath tube 1200 form a constriction lumen, which is used to constrict the stent graft 100, so that the stent graft 100 can be sleeved outside the inner core tube 1100 and radially constricted by the outer sheath tube 1200 from an expanded state to a constricted state. Those skilled in the art can construct the catheter assembly 1000 according to actual needs and adaptively constrict the stent graft 100, which will not be described and limited here.

[0058] The adjustment assembly 2000 is an assembly structure for adjusting the shape of the stent graft 100, and the adjustment assembly 2000 can include an adjustment wire 2100 movably arranged in the constriction lumen between the inner core tube 1100 and the outer sheath tube 1200, so that the adjustment wire 2100 is detachably connected to the distal end region of the small-curved side of the stent graft 100. It can be understood that the distal end region of the small-curved side of the stent graft 100 refers to the region near the distal end of the small-curved side of the stent graft 100, and it can also be understood as the region near the small-curved side of the distal end of the stent graft 100. The detachable connection of the adjustment wire 2100 to the stent graft 100 means that the adjustment wire 2100 can be kept connected to the stent graft 100 in an intended state, and the connection of the adjustment wire 2100 to the stent graft 100 can withstand a certain degree of tension without separation. At the same time, when the operator needs to separate the adjustment wire 2100 from the stent graft 100, the operator can actively control the separation of the adjustment wire 2100 from the stent graft 100 and smoothly withdraw from the body.

[0059] The adjustment wire 2100 can be made of a high molecular material and can have a certain flexibility. For example, the adjustment wire 2100 can use polyester fiber or ultra-high molecular polyethylene material. The adjustment wire 2100 can be detachably connected to the stent graft 100 in various ways such as clamping, clamping, winding, and locking, and those skilled in the art can select appropriate materials or structures according to needs, which will not be limited here.

[0060] Continuing to refer to Figures 1 to 6As shown, the delivery device can first pass the stent-graft 100 through the catheter assembly 1000 to build a sheathed shaft lumen between the outer wall of the inner core tube 1100 and the inner wall of the outer sheath tube 1200, so that the stent-graft 100 is kept in a sheathed state. Under the guidance of the guide wire 200, the delivery device can be advanced along the corresponding blood vessel in the living body until reaching the target position. For example, for the treatment of aortic dissection, the delivery device can be advanced along the ascending aorta. When the delivery device reaches the target position, the outer sheath tube 1200 of the delivery device is withdrawn. After the outer sheath tube 1200 releases the stent-graft 100, the stent-graft 100 can be deployed, so that the stent-graft 100 changes from the sheathed state to the expanded state.

[0061] Before the operator adjusts the stent-graft 100 through the adjustment assembly 2000, the distal end region of the small-curved side of the stent-graft 100 can have a poor apposition phenomenon on the inner wall of the artery, which can be referred to as a "beak" phenomenon, as indicated by arrow ①. In order to solve the "beak" phenomenon caused by the poor apposition of the stent-graft 100, the delivery device is also provided with an adjustment assembly 2000 (as shown in Figure 9 and Figure 10 ), as shown in Figure 2 The distal end of the adjustment wire body 2100 is connected to the distal end region of the small-curved side of the stent-graft 100, so that the operator pulls the proximal end of the adjustment wire body 2100 outside the living body, so that the adjustment wire body 2100 can apply a pulling force to the distal end region of the small-curved side of the stent-graft 100 along the axial direction of the stent-graft 100, and adjust the position of the distal end region of the small-curved side of the stent-graft 100 by using the pulling force. During the adjustment process, since the adjustment wire body 2100 is only detachably connected to the distal end region of the small-curved side of the stent-graft 100, when pulled, only the shape of the small-curved side of the stent-graft 100 can be changed, and the large-curved side of the stent-graft 100 remains unchanged. The small-curved side of the stent-graft 100 will deviate from the proximal end by a certain angle, for example Figure 7 and Figure 8 As shown in the comparison of Figure 3 , the operator can judge whether the small-curved side of the stent-graft 100 is adjusted to the expected shape under the DSA imaging and other means, so that the distal end region of the small-curved side of the stent-graft 100 can have a good apposition effect, as shown in

[0062] With the detachable connection of the adjustment wire body 2100 and the stent-graft 100, after the "beak" phenomenon is adjusted, the operator can actively separate the adjustment wire body 2100 from the stent-graft 100, and then the adjustment wire body 2100 is withdrawn from the living body towards the proximal end, for example along Figure 2 or Figure 3The direction indicated by the middle arrow ② is to withdraw the adjustment wire 2100 from the living body. In this process, the adjustment wire 2100 in the adjustment assembly 2000 moves in the constricted shaft cavity between the inner core tube 1100 and the outer sheath tube 1200, and the surgeon can independently control the axial movement of the adjustment wire 2100 to exert a pulling force on the distal end region of the small-curved side of the stent-graft 100, without the need to move any other components of the delivery device during the exertion of the pulling force, which can adjust the "beak" phenomenon of the stent-graft 100 caused by poor wall adhesion, while keeping the positions of other components in the delivery device and the overall position of the stent-graft 100 from moving unexpectedly.

[0063] The delivery device of the present application can adjust the distal end region of the small-curved side of the stent-graft 100 delivered to the target position (such as the ascending aorta) to the desired shape during the delivery of the stent-graft 100, through the cooperation of the catheter assembly 1000 and the adjustment assembly 2000, thereby achieving good wall adhesion performance of the stent-graft 100. Moreover, during the adjustment of the stent-graft 100 by the adjustment assembly 2000, only the adjustment assembly 2000 needs to be controlled to achieve the adjustment of the stent-graft 100. By adjusting the stent-graft 100 by the adjustment assembly 2000, not only is it stable and controllable, but it also ensures that the stent-graft 100 is stably positioned at the target position during the release and adjustment shape, without displacement.

[0064] Referring to Figure 9 and Figure 10 In one embodiment, the adjustment assembly 2000 can further include a connecting element 2200, which can be of various structures. The surgeon can previously fix the connecting element 2200 to the distal end region of the small-curved side of the stent-graft 100 in various ways such as bonding, winding, clamping, etc., so that the distal end of the adjustment wire 2100 is detachably connected to the connecting element 2200, and then the distal end of the adjustment wire 2100 is detachably connected to the distal end region of the small-curved side of the stent-graft 100.

[0065] The connecting element 2200 can be constructed in a structure convenient for connection, such as a connecting ring, a connecting coil, a connecting rope, etc., according to the adjustment wire 2100. In one embodiment, the connecting element 2200 can be provided as an integral 8-shaped coil structure. Such a coil structure occupies a small volume and can be connected to the inner side of the stent-graft 100 without affecting other functions of the stent-graft 100. In addition, those skilled in the art can construct other specific forms of the connecting element 2200 according to actual needs, which are not limited herein.

[0066] In addition, referring to Figure 2 and Figure 10As shown, in one embodiment, the adjustment assembly 2000 can further comprise a restraining element 2300, which can be in the form of an elongated structure such as a rod, so that the restraining element 2300 can be moved in the constricted shaft lumen between the inner core tube 1100 and the outer sheath tube 1200 and extend to the distal end of the stent-graft 100. For example, the restraining element 2300 can be in the form of a control wire made of metal, so that the restraining element 2300 itself has a certain supporting force. As shown, Figure 10 As shown, the distal end of the restraining element 2300 can be formed in a tapered structure. If the distal end of the restraining element 2300 is tapered, the distal end of the restraining element 2300 can not only avoid the blood vessel as much as possible, but even if the distal end of the restraining element 2300 contacts the blood vessel, the damage to the blood vessel caused by the thinner structure of the distal end of the restraining element 2300 will be reduced.

[0067] The restraining element 2300 can be used to keep the distal end of the adjustment wire 2100 and the connecting element 2200 together. By restraining the restraining element 2300, the adjustment wire 2100 can always be connected to the connecting element 2200, so when the operator needs to separate the adjustment wire 2100 and the connecting element 2200, he only needs to withdraw the restraining element 2300, for example, Figure 3 and Figure 4 As shown, the restraining element 2300 is withdrawn proximally from the body, i.e. in the direction indicated by arrow ②. As can be seen, the adjustment wire 2100 can be detachably connected to the connecting element 2200 in this way by the restraining element 2300.

[0068] As can be seen, the adjustment assembly 2000 composed of the adjustment wire 2100, the restraining element 2300 and the connecting element 2200 can be formed in a modular structure, which has no coupling effect with other parts of the delivery system, so it will not affect the functions of other parts of the delivery system, and the entire delivery system does not need to be moved as a whole to realize the adjustment function, which can effectively reduce the damage to the blood vessel and the valve caused by the overall movement of the delivery system. Moreover, after the adjustment wire 2100 of the adjustment assembly 2000 is emitted from the inner core tube 1100 and the outer sheath tube 1200, it extends to the distal side of the small bend of the stent-graft 100, and the position where the adjustment wire 2100 is emitted is far away from the distal end of the small bend of the stent-graft 100 in the axial direction, so when the small bend of the stent-graft 100 is adjusted, the resulting force is mainly the axial force, and the radial force is small, i.e. the force towards the large bend of the stent-graft 100 is small, which is suitable for patients with a large curvature of the blood vessel.

[0069] Referring to Figure 10 and Figure 11As shown, in one embodiment, the connecting element 2200 can have at least two constraint holes, a first constraint hole 2200a and a second constraint hole 2200b. The distal end of the adjustment wire 2100 can pass through the first constraint hole 2200a, and the distal end of the constraint element 2300 can pass through the second constraint hole 2200b. Then, the distal end of the constraint element 2300 is connected with the distal end of the adjustment wire 2100, and the movement of the adjustment wire 2100 is constrained by the constraint element 2300, so that the adjustment wire 2100 cannot be separated from the second constraint hole 2200b, thereby limiting the separation of the distal end of the adjustment wire 2100 from the connecting element 2200 in this way.

[0070] The distal end of the constraint element 2300 and the distal end of the adjustment wire 2100 can be connected in various ways to have a constraint effect, for example, referring to Figure 12 As shown, in one embodiment, the distal end of the adjustment wire 2100 also has a constraint loop 2100a, and at least a part of the constraint loop 2100a can pass through the first constraint hole 2200a. For example Figure 10 and Figure 11 The distal end of the constraint element 2300 passes through the second constraint hole 2200b and the constraint loop 2100a at the same time. As long as the constraint loop 2100a of the distal end of the adjustment wire 2100 does not separate from the constraint element 2300, the constraint element 2300 can limit the constraint loop 2100a from separating from the first constraint hole 2200a, thereby limiting the separation of the distal end of the adjustment wire 2100 from the connecting element 2200. In addition, those skilled in the art can also use other ways such as bonding, clamping, clamping, etc. to realize the connection of the distal end of the constraint element 2300 and the distal end of the adjustment wire 2100, which is not limited here.

[0071] Referring to Figure 13 As shown, the number of connecting elements 2200 and adjustment wires 2100 can be selected to be multiple, and multiple connecting elements 2200 can be arranged at different circumferential positions in the distal end region of the small-curved side of the stent graft 100, and each adjustment wire 2100 is detachably connected with at least one connecting element 2200. Referring to Figure 13As shown, the line connecting the adjacent connecting element 2200 and the center of the stent graft 100 can form an angle β, such as β = 30°, β = 45°, β = 60°, etc. When the small-curved side of the stent graft 100 and the small-curved side of the ascending aorta and other blood vessels deviate, the operator can adjust the different adjustment line bodies 2100 according to the actual deviation, and when pulling the adjustment line body 2100 from the proximal end of the different adjustment line body 2100, the connecting element 2200 connected with the corresponding adjustment line body 2100 will pull the different positions in the distal end region of the small-curved side of the stent graft 100, so that the operator can apply pulling force to different positions for targeted control of the stent graft 100 and the ascending aorta to form a state of abutment. Under the DSA imaging and other means, this adjustment mode can accurately adjust the distal end region of the small-curved side of the stent graft 100 to the blood vessel wall, and finally adjust the stent graft 100 to the desired shape.

[0072] Continuing to refer to Figure 14 As shown, in one embodiment, the adjustment assembly 2000 further comprises a first binding element 2400 or a second binding element 2500, which can be made of a high molecular material, such as polyester fiber or ultra-high molecular polyethylene. The first binding element 2400 and the second binding element 2500 can be used to define the extension shape of the adjustment line body 2100 and the constraint element 2300 on the stent graft 100, respectively.

[0073] For example, one or more first binding elements 2400 can be provided, and when the first binding elements 2400 are multiple, the first binding elements 2400 can be arranged on the small-curved side of the stent graft 100 along the axial direction of the stent graft 100, and the adjustment line body 2100 can be connected to the multiple first binding elements 2400, so that the adjustment line body 2100 can also be arranged along the axial direction of the small-curved side of the stent graft 100. One or more second binding elements 2500 can also be provided, and when the second binding elements 2500 are multiple, the second binding elements 2500 can be arranged on the small-curved side of the stent graft 100 along the axial direction of the stent graft 100, and the constraint element 2300 can be connected to the multiple second binding elements 2500, so that the constraint element 2300 can also be arranged along the axial direction of the small-curved side of the stent graft 100. Among them, the first binding element 2400 or the second binding element 2500 can adopt a structure such as a coil, a clasp, etc. that can pass through the adjustment line body 2100 or the constraint element 2300, which is not limited here.

[0074] When the distal end of the adjustment line body 2100 has a constraint coil 2100a, the constraint coil 2100a can be controlled to form a connection with the first binding element 2400, for example, the first binding element 2400 is also a coil structure, and the operator can pull the adjustment line body 2100 from the proximal end of the adjustment line body 2100, so that the constraint coil 2100a connected with the adjustment line body 2100 can be pulled to the first binding element 2400, and the constraint coil 2100a can be connected to the first binding element 2400. Figure 14The constraint coil 2100a of the two-wire body is threaded through the first binding element 2400, and does not present as shown Figure 14 The adjustment wire 2100 of the single-wire body is threaded through the first binding element 2400. In one embodiment, the number of the first binding elements 2400 is plural, and the plural first binding elements 2400 are arranged along the axial direction of the stent-graft 100 at the small-curve side of the stent-graft 100. The distance between the connection element 2200 and the most distant first binding element 2400 is L1, and the length of the constraint coil 2100a is L2. It is defined that 2L1 is less than or equal to L2. Thus, when the constraint coil 2100a is withdrawn from the body, the node of the adjustment wire 2100 will not hook on the first binding element 2400 of the stent-graft 100, thereby avoiding the displacement of the stent-graft 100.

[0075] Thus, for example, referring to Figure 14 When the constraint coil 2100a is contracted to be linear, presenting as shown Figure 14 the two-wire body, the actual length of the constraint coil 2100a of the two-wire body is 1 / 2L2, which is greater than the distance L1 between the connection element 2200 and the most distant first binding element 2400. Thus, the length of the constraint coil 2100a when stretched can exceed the distance between the connection element 2200 and the most distant first binding element 2400, thereby avoiding the adjustment wire 2100 of the single-wire body threaded through the first binding element 2400.

[0076] The first constraint hole 2200a is a circular hole, and the inner diameter of the first constraint hole 2200a is at least twice greater than the wire diameter of the adjustment wire 2100. The larger hole diameter difference can ensure that the adjustment wire 2100 is smoothly detached from the first constraint hole 2200a when withdrawn and detached from the stent-graft 100, and will not cause the stent-graft 100 to move unexpectedly due to friction, interference, etc. with the connection element 2200. Similarly, the second constraint hole 2200b is a circular hole, and the inner diameter of the second constraint hole 2200b can also be appropriately greater than the maximum diameter of the constraint element 2300, which is not limited here.

[0077] The distal end of the inner core tube 1100 is used to detachably connect with the distal end region of the large-curve side of the stent-graft 100. Continuing to refer to Figure 5 and Figure 6 Before the stent-graft 100 is adjusted, the distal end of the inner core tube 1100 can remain connected with the stent-graft 100, so that the stent-graft 100 is in place and does not move unexpectedly during the adjustment process. When the stent-graft 100 is adjusted, the distal end of the inner core tube 1100 can be separated from the stent-graft 100, at which time the inner core tube 1100 is withdrawn, and the stent-graft 100 can be released in the blood vessel.

[0078] Referring to Figure 15 and Figure 16 In one embodiment, the catheter assembly 1000 further includes a guide element 1300 and a release wire 1400. The guide element 1300 is disposed at the distal end of the inner core tube 1100. The guide element 1300 can have a rounded conical head structure for guiding the advancement of the delivery device in the blood vessel. The release wire 1400 is movably disposed in the constricted lumen between the inner core tube 1100 and the outer sheath tube 1200. The release wire 1400 can be used by the operator to detachably connect the distal end region of the large curved side of the stent graft 100 to the guide element 1300. The detachable connection of the release wire 1400 to the stent graft 100 means that the release wire 1400 can be kept connected to the stent graft 100 in the intended state. When the operator needs to separate the release wire 1400 from the stent graft 100, the operator can actively control the release wire 1400 to separate from the stent graft 100 and be smoothly withdrawn from the body.

[0079] The release wire 1400 can be detachably connected to the stent graft 100 in various ways such as clamping, clamping, winding, locking, etc. The skilled person can choose appropriate materials or structures according to the needs, which are not limited herein. In one embodiment, the stent graft 100 is generally formed by a stent body and a covering film on the stent body. The distal end or proximal end of the stent body is usually not covered by the covering film, and the exposed end portion can be referred to as a stent bare segment. The distal end of the release wire 1400 can be connected to the stent graft 100 by passing through the stent bare segment as shown in Figure 15

[0080] Referring to Figure 15 In one embodiment, the catheter assembly 1000 further includes a guide frame 1500. The guide frame 1500 has a first assembly channel 1500a and a second assembly channel 1500b. The inner core tube 1100 is disposed in the first assembly channel 1500a, and the release wire 1400 is disposed in the second assembly channel 1500b. The guide frame 1500 can be used to support the inner core tube 1100 and the release wire 1400, so that the inner core tube 1100 and the release wire 1400 are kept together. The distal end of the release wire 1400 passes through the stent bare segment of the stent graft 100 and is connected to the guide element 1300, so as to realize the connection with the stent graft 100. The release wire 1400 or the guide frame 1500 can be made of a metal material.

[0081] ​The application also provides a delivery system, which comprises a delivery device and the stent-graft 100, wherein the delivery device is used for delivering the stent-graft 100. Since the specific structure, functional principle and technical effects of the delivery device have been described in the foregoing, no further description is given here. Any technical content related to the delivery device can refer to the foregoing description.

[0082] Any combination of the technical features of the above-mentioned embodiments can be made. In order to make the description simple, all possible combinations of the technical features in the above-mentioned embodiments are not described, however, as long as the combination of the technical features does not exist contradictory, it should be considered as the scope of the description.

[0083] The above-mentioned embodiments only express several implementation manners of the application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the patent application scope. It should be pointed out that, for ordinary skilled in the art, several modifications and improvements can be made without departing from the concept of the application, and these all belong to the protection scope of the application. Therefore, the patent protection scope of the application should be subject to the appended claims.

Claims

1. A delivery device characterized by, The delivery device comprises: a catheter assembly comprising an inner core tube and an outer sheath tube, the inner core tube movably fitted in a sheath lumen of the outer sheath tube, a constriction shaft lumen being formed between an outer wall of the inner core tube and an inner wall of the outer sheath tube, the constriction shaft lumen being used for constriction of a stent graft; an adjustment assembly comprising an adjustment wire, a connecting element and a constraint element, the adjustment wire being threaded in the constriction shaft lumen and detachably connected with a distal end region of a small-curved side of the stent graft; the connecting element being arranged at the distal end region of the small-curved side of the stent graft, a distal end of the adjustment wire being detachably connected with the connecting element; the constraint element being movably threaded in the constriction shaft lumen, the adjustment wire being detachably connected with the connecting element through the constraint element; the connecting element has a first constraint hole and a second constraint hole, the adjustment wire is threaded through the first constraint hole, the constraint element is threaded through the second constraint hole, a distal end of the constraint element is connected with a distal end of the adjustment wire, for limiting the distal end of the adjustment wire from being separated from the connecting element; the distal end of the adjustment wire has a constraint coil, at least a part of the constraint coil is threaded through the first constraint hole, the distal end of the constraint element is sequentially threaded through the second constraint hole and the constraint coil, for limiting the distal end of the adjustment wire from being separated from the connecting element.

2. The delivery device of claim 1, wherein, the distal end of the constraint element has a variable diameter structure gradually tapered from a proximal end to a distal end.

3. The delivery device of claim 2, wherein, the first constraint hole is a circular hole, an inner diameter of the first constraint hole is at least twice greater than a wire diameter of the adjustment wire.

4. The delivery device of any of claims 1-3, wherein, the adjustment assembly further comprises: a first binding element for being arranged along an axial direction of the stent graft at the small-curved side of the stent graft, so that the adjustment wire is arranged along the axial direction of the small-curved side of the stent graft; and / or, a second binding element for being arranged along the axial direction of the stent graft at the small-curved side of the stent graft, so that the constraint element is arranged along the axial direction of the small-curved side of the stent graft.

5. The delivery device of claim 4, wherein, the number of the first binding elements is multiple, all the first binding elements are arranged along the axial direction of the stent graft at the small-curved side of the stent graft, a distance between the connecting element and the most distant first binding element is L1, a coil length of the constraint coil is L2, wherein 2L1 is less than or equal to L2.

6. The delivery device of claim 4, wherein, the number of the connecting elements and the number of the adjustment wires are both multiple, all the connecting elements are arranged at different circumferential positions of the distal end region of the small-curved side of the stent graft, each of the adjustment wires is detachably connected with at least one of the connecting elements.

7. The delivery device of claim 1, wherein, a distal end of the inner core tube is used for being detachably connected with a distal end region of a large-curved side of the stent graft.

8. The delivery device of claim 7, wherein, the catheter assembly further comprises: a guide element arranged at the distal end of the inner core tube; a release wire movably threaded in the constriction shaft lumen, for detachably connecting the distal end region of the large-curved side of the stent graft with the guide element.

9. The delivery device of claim 8, wherein, the catheter assembly further comprises: A guide frame body having a first assembly passage and a second assembly passage, the inner core tube is threaded in the first assembly passage, the release wire body is threaded in the second assembly passage, the distal end of the release wire body is used to pass through the stent bare segment of the stent graft and is connected with the guide element.

10. A delivery system characterized by, The delivery device of any one of claims 1 to 9 for delivering the stent graft.

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