Delivery assembly and delivery system
By designing an external catheter with an axial bending resistance zone, it can bend flexibly in three-dimensional space, solving the problem that existing catheters cannot actively control bending, ensuring precise coaxial release of the valve stent, and improving surgical outcomes.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO LTD
- Filing Date
- 2023-04-21
- Publication Date
- 2026-06-12
Smart Images
Figure CN116370153B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to delivery components and delivery systems. Background Technology
[0002] Heart valve replacement surgery, such as aortic valve replacement, mitral valve replacement, tricuspid valve replacement, and pulmonary valve replacement, involves placing a valve through a catheter into a designated location and releasing it to replace the existing valve. This is a highly sought-after technique in the treatment of valvular heart disease. For example, transcatheter aortic valve replacement can treat aortic valve disease without open-heart surgery or stopping the heart, avoiding the significant trauma caused by open-heart surgery and cardiac arrest.
[0003] Currently, the catheters used in transcatheter aortic valve replacement (TAVR) cannot actively bend in three-dimensional space. When passing through the aortic arch, the catheter relies on the reaction force exerted by the vessel wall to passively bend, thus facilitating its passage. This process may cause some damage to the vessel wall, leading to vascular complications. Furthermore, during subsequent transcatheter aortic valve replacement procedures such as valve repositioning and coaxial alignment, the inability of the catheter to actively bend makes it difficult to ensure that the valve annulus and aortic arch are on the same plane, significantly hindering the release and fixation of the valve stent.
[0004] Therefore, how to achieve precise coaxial release of the valve stent in a three-dimensional arc shape through adjustable three-dimensional spatial bending is a technical problem that urgently needs to be solved in this field. Summary of the Invention
[0005] Therefore, it is necessary to provide a conveying component and a conveying system to address the aforementioned technical problems.
[0006] An external conduit for a delivery system, the external conduit comprising:
[0007] The main tube layer has an axial inner cavity. The main tube layer includes a curved outer tube segment and a pushing outer tube segment in the axial direction. The curved outer tube segment has a first axially extending anti-bending region for resisting bending of the curved outer tube segment along the axial plane where the first axially extending anti-bending region is located. The pushing outer tube segment has a second axially extending anti-bending region for resisting bending of the pushing outer tube segment along the axial plane where the second axially extending anti-bending region is located. An angle can be formed between the axial plane where the first axially extending anti-bending region is located and the axial plane where the second axially extending anti-bending region is located.
[0008] In one embodiment, the curved outer tube segment and the pushing outer tube segment are integrally formed, with the proximal end of the curved outer tube segment fixedly connected to the distal end of the pushing outer tube segment; or,
[0009] The curved outer tube segment and the pushing outer tube segment are separate structures. The proximal end of the curved outer tube segment is rotatably connected to the distal end of the pushing outer tube segment. Based on the fixed-axis rotation between the curved outer tube segment and the pushing outer tube segment, the plane angle between the axial plane where the first axial bending region is located and the axial plane where the second axial bending region is located can be adjusted.
[0010] In one embodiment, the proximal end of the curved outer tube segment and the distal end of the pushing outer tube segment are respectively provided with a cooperating steering adjustment hole and an angle locking component. The steering adjustment hole is opened along the circumferential direction, and the angle locking component slides along the steering adjustment hole to adjust the fixed-axis rotation angle between the curved outer tube segment and the pushing outer tube segment.
[0011] In one embodiment, the curved outer pipe segment has two first axial bending resistance regions, the two first axial bending resistance regions being symmetrical with respect to the central axis of the curved outer pipe segment; and / or,
[0012] The outer push tube segment has two second axial bending resistance regions, which are symmetrical with respect to the central axis of the outer push tube segment.
[0013] In one embodiment, the surface of the bent outer tube segment has an axially extending bendable region that does not intersect with the axial plane of the first axial bending resistance region. The bendable region is designed to allow the bent outer tube segment to bend in a direction perpendicular to the axial plane of the first axial bending resistance region.
[0014] In one embodiment, the curved outer pipe segment has two bendable regions, which are symmetrical with respect to the central axis of the curved outer pipe segment.
[0015] In one embodiment, a plurality of first hollow holes are provided in the bendable area of the outer tube. The first hollow hole includes a first arc-shaped hole and two first circular holes located at both ends of the first arc-shaped hole. The first arc-shaped hole extends circumferentially and is perpendicular to the central axis of the bendable outer tube segment. The plurality of first hollow holes are arranged along the axial direction of the bendable outer tube segment. The area between the two bendable areas of the outer tube forms the first axial bending resistance area.
[0016] In one embodiment, a plurality of second arc-shaped holes extending circumferentially are provided in the bendable region of the outer tube. These second arc-shaped holes are perpendicular to the central axis of the bent outer tube segment, and the plurality of second arc-shaped holes are arranged axially along the bent outer tube segment; and / or,
[0017] At least two axial straight holes extending along the axial direction are provided in the first axial bending region, and bending ribs for resisting bending of the bent outer pipe section are constructed between the two axial straight holes.
[0018] In one embodiment, the axial straight hole includes a plurality of unit straight holes that are axially spaced apart.
[0019] In one embodiment, a plurality of arc-shaped cut grooves extending circumferentially are provided in the bendable region of the outer tube. The arc-shaped cut grooves are perpendicular to the central axis of the bendable outer tube segment, and the plurality of arc-shaped cut grooves are arranged along the axial direction of the bendable outer tube segment. The plurality of arc-shaped cut grooves located in two bendable regions of the outer tube have partially intersecting groove segments in the circumferential direction.
[0020] In one embodiment, the proximal end of the curved outer tube segment has a diameter-reducing section, which is connected to the distal end of the pushing outer tube segment, and the diameter of the diameter-reducing section of the curved outer tube segment gradually decreases from the distal end to the proximal end; and / or,
[0021] The outer layer of the curved outer pipe section has an outer outer pipe layer, and the inner layer of the curved outer pipe section has an inner outer pipe layer.
[0022] A conveying assembly, the conveying assembly comprising:
[0023] The external catheter;
[0024] An inner catheter having a guiding lumen, the inner catheter being movably fitted within the axial lumen of the outer catheter;
[0025] A traction wire, the traction wire being connected to at least one of the outer conduit and the inner conduit;
[0026] A stent body, on which a valve is fitted, the stent body and the valve being configured for fitting between the inner catheter and the outer catheter.
[0027] In one embodiment, the conveying component includes:
[0028] A support fixture, wherein the support fixture is disposed at the distal end of the inner conduit; and / or,
[0029] The inner core tube has a core tube lumen, the proximal end of the inner core tube is connected to the distal end of the inner catheter, and at least one of the guide lumen and the core tube lumen is used to thread a guide wire.
[0030] In one embodiment, the bracket fixing member has an inner cavity that communicates with the guide cavity; and / or,
[0031] The bracket fastener has a wire fixing part; and / or,
[0032] The bracket fastener has a bracket fixing part; and / or,
[0033] The distal end of the inner core tube is provided with a distal guide.
[0034] In one embodiment, at least a portion of the axial segment of the inner conduit has an axially extending inner tube axial bending resistance region, the inner tube axial bending resistance region being used to resist bending of the inner conduit along the axial plane where the inner tube axial bending resistance region is located.
[0035] In one embodiment, the inner catheter has two axial bending resistance regions, which are symmetrical with respect to the central axis of the inner catheter.
[0036] In one embodiment, the inner conduit includes a curved inner tube segment and a pushing inner tube segment in the axial direction, the proximal end of the curved inner tube segment being connected to the distal end of the pushing inner tube segment, and the axial bending resistance region of the inner tube being provided at least on the curved inner tube segment.
[0037] In one embodiment, the distal end of the traction wire is connected to the distal end of the curved inner tube segment; or,
[0038] The traction wire is threaded through the guiding lumen of the inner catheter; or,
[0039] At least a portion of the axial section of the inner catheter has a traction channel, and the traction wire is threaded through the traction channel of the inner catheter.
[0040] In one embodiment, the curved inner tube segment includes an outer inner tube layer, an inner inner tube layer, and a reinforcing tube layer located between the outer inner tube layer and the inner inner tube layer.
[0041] In one embodiment, a traction channel is provided between the outer layer of the inner tube and the reinforcing tube layer; or, a traction channel is provided on the inner wall of the inner layer of the inner tube.
[0042] In one embodiment, the surface of the bent inner tube segment has an axially extending bendable region that does not intersect with the axial plane of the inner tube axial resistance region. The bendable region is designed to allow the bent inner tube segment to bend in a direction perpendicular to the axial plane of the inner tube axial resistance region.
[0043] In one embodiment, the curved inner tube segment has two bendable regions, which are symmetrical with respect to the central axis of the curved inner tube segment.
[0044] In one embodiment, a plurality of second hollow holes are provided in the bendable area of the inner tube. The second hollow holes include a third arc-shaped hole and two second circular holes located at both ends of the third arc-shaped hole. The third arc-shaped hole extends circumferentially and is perpendicular to the central axis of the bendable inner tube segment. The plurality of second hollow holes are arranged along the axial direction of the bendable inner tube segment. The area between the two bendable areas of the inner tube forms the axial bending resistance area of the inner tube.
[0045] In one embodiment, the curved inner tube segment includes a plurality of rotatably connected unit joints along its axial direction, with a fixed-axis transition portion between adjacent unit joints located in the axial bending resistance region of the inner tube, and a rotational gap between adjacent unit joints located in the bending easy region of the inner tube.
[0046] In one embodiment, the fixed-axis transition portion includes a pivot and a shaft hole located on an adjacent unit joint; or,
[0047] The fixed-axis adapter includes a first rotating fastening structure and a second rotating fastening structure located on adjacent unit joints. The first rotating fastening structure includes a first arc-shaped sliding groove, a first arc-shaped fastening arm, and a central fastening groove. The second rotating fastening structure includes a second arc-shaped sliding groove, a second arc-shaped fastening arm, and a central fastening head. The first arc-shaped fastening arm is slidably assembled along the second arc-shaped sliding groove, and the second arc-shaped fastening arm is slidably assembled along the first arc-shaped sliding groove. The central fastening head and the central fastening groove are rotatably assembled.
[0048] A conveying system, the conveying system comprising:
[0049] The external conduit; or, the delivery assembly.
[0050] In the aforementioned delivery components and delivery system, the first and second axial bending regions of the external catheter are misaligned at a certain circumferential angle, allowing the bending and pushing sections of the external catheter to bend in different planes. This enables the external catheter to bend flexibly in three-dimensional space, allowing it to pass smoothly through lumens such as aortic arches of different shapes within the body. Furthermore, based on the active bending control of the external catheter in three-dimensional space, it ensures that the human valve annulus and aortic arch are on the same plane, facilitating coaxial adjustment and valve stent release, and effectively improving surgical outcomes. Attached Figure Description
[0051] Figure 1 This is a schematic diagram of the first bending state of the external conduit provided in one embodiment of this application.
[0052] Figure 2 This is a schematic diagram of the second bending state of the external conduit provided in one embodiment of this application.
[0053] Figure 3 This is a schematic diagram of the flexible range structure of the external conduit provided in one embodiment of this application.
[0054] Figure 4 This is a structural schematic diagram of the circumferential rotation angle of the curved outer pipe section and the pushed outer pipe section provided in one embodiment of this application.
[0055] Figure 5 For example Figure 4 The diagram shows a planar structure of the curved outer pipe section and the pushed outer pipe section, which can rotate circumferentially.
[0056] Figure 6 This is a schematic diagram of the assembly structure of the external and internal catheters provided in one embodiment of this application.
[0057] Figure 7 This is a schematic diagram of the internal catheter provided in one embodiment of this application.
[0058] Figure 8 This is a schematic diagram of the structure of a curved outer pipe segment provided in one embodiment of this application.
[0059] Figure 9 This is a schematic diagram of the structure of a curved outer pipe segment provided in another embodiment of this application.
[0060] Figure 10 This is a schematic diagram of the structure of a curved outer pipe segment provided in another embodiment of this application.
[0061] Figure 11 This is a schematic diagram of the structure of the main tube layer, the outer tube outer layer, and the outer tube inner layer provided in one embodiment of this application.
[0062] Figure 12 This is a schematic diagram of the structure of the outer layer and the inner layer of the inner tube provided in one embodiment of this application.
[0063] Figure 13 This is a three-dimensional assembly structure diagram of the curved inner tube segment and the bracket fixing member provided in one embodiment of this application.
[0064] Figure 14 This is a schematic diagram of the planar assembly structure of the curved inner tube segment and the bracket fixing member provided in one embodiment of this application.
[0065] Figure 15 This is a structural schematic diagram of a bracket fixing member provided in one embodiment of this application.
[0066] Figure 16 This is a schematic diagram of the structure of a curved inner pipe segment provided in one embodiment of this application.
[0067] Figure 17 This is a schematic diagram of the structure of a curved inner tube segment provided in another embodiment of this application.
[0068] Figure 18 This is a schematic diagram of the structure of a curved inner pipe segment provided in another embodiment of this application.
[0069] Figure 19 This is a schematic diagram of the structure of the traction wire passing through the guide cavity in one embodiment of this application.
[0070] Figure 20 This is a schematic diagram of the structure of the traction wire passing through the traction channel according to one embodiment of this application.
[0071] Figure 21 This is a schematic diagram of the structure of the traction wire passing through the traction channel according to another embodiment of this application.
[0072] Icon labels:
[0073] 1000, External catheter; 2000, Internal catheter; 3000, Traction wire; 4000, Support fastener; 5000, Inner core tube;
[0074] 1100, Main pipe layer; 1200, Bending outer pipe section; 1300, Pushing outer pipe section;
[0075] 1100a, Outer layer of outer tube; 1100b, Inner layer of outer tube; 1200a, Steering adjustment hole; 1200b, Corner locking component; 1200c, Sealing component; 1210, First axial bending resistance zone; 1220, Bendable zone of outer tube; 1310, Second axial bending resistance zone;
[0076] 1221. First hollow hole; 1222. Second arc-shaped hole; 1223. Arc-shaped notch;
[0077] 1221a, First arc-shaped hole; 1221b, First circular hole; 1222a, Axial straight hole;
[0078] 4100, Inner cavity; 4200, Wire fixing part; 4300, Bracket fixing part; 4400, Distal guide;
[0079] 2100, Bending inner pipe section; 2200, Pushing inner pipe section;
[0080] 2100a, outer layer of inner tube; 2100b, inner layer of inner tube; 2100c, reinforcing tube layer; 2100d, guiding inner cavity;
[0081] 2110. Axial bending resistance zone of inner tube; 2120. Easy bending zone of inner tube; 2130. Traction channel;
[0082] 2121. Second hollow hole; 2122. Unit joint component;
[0083] 2121a, Third arc-shaped hole; 2121b, Second circular hole; 2122a, Fixed-axis transition part; 2122b, Rotation clearance;
[0084] 2122a1, First arc-shaped sliding groove; 2122a2, First arc-shaped fastening arm; 2122a3, Central fastening groove; 2122a4, Second arc-shaped sliding groove; 2122a5, Second arc-shaped fastening arm; 2122a6, Central fastening head. Detailed Implementation
[0085] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.
[0086] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.
[0087] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.
[0088] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.
[0089] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.
[0090] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening 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 intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.
[0091] To more clearly describe the structure of the delivery assembly, the term "distal end" is defined herein as the end furthest from the operator during the surgical procedure, and "proximal end" as the end closest to the operator during the surgical procedure. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application's specification is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
[0092] See Figure 1 As shown, one embodiment of this application provides an outer conduit 1000 for a delivery system. The outer conduit 1000 includes a main tube layer 1100 with an axial inner cavity. The main tube layer 1100 includes a curved outer tube segment 1200 and a pushing outer tube segment 1300 in the axial direction. The curved outer tube segment 1200 has a first axial bending resistance region 1210 extending axially, which resists bending of the curved outer tube segment 1200 along the axial plane where the first axial bending resistance region 1210 is located. The pushing outer tube segment 1300 has a second axial bending resistance region 1310 extending axially, which resists bending of the pushing outer tube segment 1300 along the axial plane where the second axial bending resistance region 1310 is located. An angle can be formed between the axial plane where the first axial bending resistance region 1210 is located and the axial plane where the second axial bending resistance region 1310 is located.
[0093] The first axial bending resistance region 1210 and the second axial bending resistance region 1310 are mainly linear regions extending along the axial direction. The width of the linear region can be set according to actual needs and is not limited here. Among them, the bending outer pipe section 1200 and the pushing outer pipe section 1300 can be in a straight state when not in use, or refer to Figure 1 As shown, the bent outer pipe section 1200 and the pushing outer pipe section 1300 can also be in a non-straight state during use. Therefore, the axial direction of the bent outer pipe section 1200 and the pushing outer pipe section 1300 can be a straight line trajectory or a curved trajectory in the straight state and the non-straight state, respectively. Correspondingly, the first axial bending resistance region 1210 and the second axial bending resistance region 1310 extending along the axial direction also form a straight line trajectory or a curved trajectory in different states.
[0094] It should be noted that the axial plane refers to the plane containing the central axis. Therefore, the axial plane where the first axial bending resistance region 1210 is located means that the plane passes through both the central axis of the bent outer pipe section 1200 and the first axial bending resistance region 1210 on the surface of the bent outer pipe section 1200. It resists the bending of the bent outer pipe section 1200 along the axial plane where the first axial bending resistance region 1210 is located, that is, it prevents the bent outer pipe section 1200 from bending smoothly along the axial plane, or even prevents the bent outer pipe section 1200 from bending along the axial plane at all. Similarly, the axial plane where the second axial bending resistance region 1310 is located is a plane that passes through both the central axis of the outer tube segment 1300 and the surface of the outer tube segment 1300. It resists the bending of the outer tube segment 1300 along the axial plane where the second axial bending resistance region 1310 is located, which means that the outer tube segment 1300 cannot bend smoothly along the axial plane, or even that the outer tube segment 1300 cannot bend along the axial plane at all.
[0095] Therefore, since the first axial bending resistance region 1210 restricts the bending direction of the outer pipe section 1200 and the second axial bending resistance region 1310 restricts the bending direction of the inner pipe section 1300, the outer pipe section 1200 is more likely to bend in other directions not restricted by the first axial bending resistance region 1210, and the inner pipe section 1300 is also more likely to bend in other directions not restricted by the second axial bending resistance region 1310. This allows the bending directions of the outer pipe section 1200 and the inner pipe section 2200 to be limited to a certain extent.
[0096] See Figure 1 As shown, when the first axial bending resistance region 1210 extends along the axial direction of the bent outer pipe section 1200 and connects with the second axial bending resistance region 1310 extending along the axial direction of the pushing outer pipe section 1300, that is, when the first axial bending resistance region 1210 and the second axial bending resistance region 1310 are not misaligned in the circumferential direction, the first axial bending resistance region 1210 and the second axial bending resistance region 1310 restrict the bending direction of the bent outer pipe section 1200 and the pushing outer pipe section 1300 in the same way. The bent outer pipe section 1200 and the pushing outer pipe section 1300 can bend in the same direction, and are also resisted in the bend in the same direction. Specifically, the bent outer pipe section 1200 and the pushing outer pipe section 1300 can bend in a two-dimensional plane.
[0097] Continue reading Figure 2As shown, when the first axial bending resistance region 1210 and the second axial bending resistance region 1310 are misaligned at a certain circumferential angle in the circumferential direction, the first axial bending resistance region 1210 and the second axial bending resistance region 1310 restrict the bending direction of the bent outer pipe section 1200 and the pushed outer pipe section 1300 differently. The bent outer pipe section 1200 and the pushed outer pipe section 1300 cannot bend in the same direction and are resisted in bending in different directions. Therefore, when the bent outer pipe section 1200 and the pushed outer pipe section 1300 are subjected to the same tensile force and bend, the bent outer pipe section 1200 and the pushed outer pipe section 1300 can bend in different planes. Specifically, the bent outer pipe section 1200 and the pushed outer pipe section 1300 can bend in three-dimensional space. Referring again to Figure 3, the circumferential angle formed by the first axial bending region 1210 and the second axial bending region 1310 in the circumferential direction can be between 1° and 90°, for example, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, etc., which are not limited here.
[0098] The curved outer tube segment 1200 and the pushing outer tube segment 1300 can be adopted as a separate structure, so that the proximal end of the curved outer tube segment 1200 and the distal end of the pushing outer tube segment 1300 are rotatably connected. Based on the fixed-axis rotation between the curved outer tube segment 1200 and the pushing outer tube segment 1300, the plane angle between the plane where the first axial bending region 1210 is located and the plane where the second axial bending region 1310 is located can be adjusted, that is, the circumferential angle formed by the first axial bending region 1210 and the second axial bending region 1310 in the circumferential direction can be adjusted. By adjusting the circumferential angle, the curved outer tube segment 1200 and the pushing outer tube segment 1300 of the external catheter 1000 can form different bending directions in three-dimensional space, thereby meeting the structural shapes of various complex vascular lumens and improving the application range of the external catheter 1000.
[0099] The rotatable connection between the bent outer tube section 1200 and the pushed outer tube section 1300 can take various forms, such as threaded connection, snap-fit connection, etc. (See reference...) Figure 4 and Figure 5As shown, in one embodiment, the proximal end of the curved outer tube section 1200 and the distal end of the pushing outer tube section 1300 are respectively provided with a cooperating steering adjustment hole 1200a and a corner locking component 1200b. The steering adjustment hole 1200a is opened circumferentially, and the corner locking component 1200b slides along the steering adjustment hole 1200a to adjust the fixed-axis rotation angle between the curved outer tube section 1200 and the pushing outer tube section 1300. For example, the steering adjustment hole 1200a is opened at the proximal end of the curved outer tube section 1200, and the distal end of the pushing outer tube section 1300 is opened at the distal end of the curved outer tube section 1200. An angle locking component 1200b is provided at the distal end of the 0. The distal end of the push outer tube section 1300 is rotatably inserted into the proximal end of the curved outer tube section 1200. The angle locking component 1200b can then extend out from the steering adjustment hole 1200a. The curved outer tube section 1200 and the push outer tube section 1300 can rotate on a fixed axis, allowing the angle locking component 1200b to slide along the steering adjustment hole 1200a. When the rotation angle is adjusted appropriately, the angle locking component 1200b can be used to lock the curved outer tube section 1200 and the push outer tube section 1300 relative to each other.
[0100] The steering adjustment hole 1200a can extend circumferentially from 1° to 90°. The corner locking component 1200b can be a snap-fit, threaded part, etc., which is not limited here. In addition, a sealing component 1200c, such as a sealing ring, can be provided between the proximal end of the curved outer tube section 1200 and the distal end of the pushing outer tube section 1300. The sealing component 1200c can prevent blood from flowing out from the gap between the curved outer tube section 1200 and the pushing outer tube section 1300 during the operation. For example, the corner locking component 1200b uses a set screw. The distal end of the push outer tube section 1300 is provided with a screw hole and a sealing ring groove, and the proximal end of the curved outer tube section 1200 is provided with a steering adjustment hole 1200a as a track. During assembly, the distal end of the push outer tube section 1300 is first fitted into the proximal end of the curved outer tube section 1200, and then the set screw is pre-screwed into the screw hole through the steering adjustment hole 1200a, but not tightened, so as to ensure that the set screw can move freely along the steering adjustment hole 1200a, so that the push outer tube section 1300 and the curved outer tube section 1200 can rotate smoothly. The position of the set screw is always consistent with the direction of the second axial bending resistance area 1310 of the push outer tube section 1300. The function of the sealing ring is to prevent blood from flowing out from the gap between the push outer tube section 1300 and the curved outer tube section 1200 during the operation.
[0101] Before surgery, doctors or technicians can freely rotate the bent outer tube 1200 to adjust the circumferential deflection angle of the first axial bending region 1210 of the bent outer tube 1200 and the second axial bending region 1310 of the pushing outer tube 1300, and tighten the set screws, based on the patient's imaging. In this case, the system can have different three-dimensional bending angles under the controlled bending state during the operation, so that the bending shape of the delivery system can better match the patient's bow shape.
[0102] In addition, in one embodiment, the curved outer tube segment 1200 and the pushing outer tube segment 1300 can also be integrally formed, with the proximal end of the curved outer tube segment 1200 and the distal end of the pushing outer tube segment 1300 fixedly connected. In this case, the bending direction of the curved outer tube segment 1200 and the pushing outer tube segment 1300 of the outer catheter 1000 in three-dimensional space is also fixed, and different regular catheters can be selected for surgical operations according to actual needs.
[0103] The outer conduit 1000 can be used in a conveying system. For example, the outer conduit 1000 and the inner conduit 2000 can be fitted together to form a conveying assembly used in a conveying system, see 6 and Figure 7 As shown, the inner catheter 2000 is movably assembled in the axial inner cavity of the outer catheter 1000. During use, the inner catheter 2000 is controlled to bend by the traction wire 3000, and the bending of the inner catheter 2000 is used to control the bending of the outer catheter 1000. Therefore, when the bending force of the inner catheter 2000 is transmitted to the outer catheter 1000, the first axial bending resistance region 1210 and the second axial bending resistance region 1310 of the outer catheter 1000 are misaligned at a certain circumferential angle, allowing the bending outer tube segment 1200 and the pushing outer tube segment 1300 of the outer catheter 1000 to bend in different planes. This enables the outer catheter 1000 to bend flexibly in three-dimensional space, allowing it to pass smoothly through lumens such as aortic arches of different shapes within the body. Moreover, the circumferential torsion angle and the active bending angle together determine the spatial orientation of the delivery targets such as valves and stents. Based on the active bending control of the outer catheter 1000 in three-dimensional space, it is possible to ensure that the human valve annulus and aortic arch are on the same plane, facilitating coaxial adjustment and the release of valve stents, and effectively improving the surgical outcome.
[0104] The bent outer pipe section 1200 may have one or more first axial bending resistance regions 1210, as long as the bending direction of the bent outer pipe section 1200 can be limited as required. For example, see [reference needed]. Figures 8 to 10 As shown, the bent outer pipe section 1200 has two first axial bending resistance regions 1210, which are symmetrical with respect to the central axis of the bent outer pipe section 1200. Therefore, the bent outer pipe section 1200 can only bend along a direction perpendicular to the plane of the axis containing the two first axial bending resistance regions 1210. Similarly, the pushing outer pipe section 1300 can have one or more second axial bending resistance regions 1310, as long as the bending direction of the pushing outer pipe section 1300 can be restricted as needed. For example, see [reference needed]. Figures 8 to 10As shown, the outer tube segment 1300 has two second axial bending resistance regions 1310. The two second axial bending resistance regions 1310 are symmetrical with respect to the central axis of the outer tube segment 1300. At this time, the outer tube segment 1300 can only bend along the direction perpendicular to the plane of the axis where the two second axial bending resistance regions 1310 are located.
[0105] Continue reading Figures 8 to 10 As shown, in one embodiment, the surface of the bent outer pipe section 1200 also has an axially extending bendable outer pipe region 1220. The bendable outer pipe region 1220 and the first axial bending resistance region 1210 can basically fill the surface of the bent outer pipe section 1200. The specific proportion on the surface of the bent outer pipe section 1200 is not limited. The outer tube's bendable region 1220 and the first axial bending resistance region 1210 have no intersection in their axial planes, so that the bending outer tube segment 1200 mainly relies on the outer tube's bendable region 1220 for bending, while being restricted by the first axial bending resistance region 1210 for bending. For example, the outer tube's bendable region 1220 is used to at least allow the bending outer tube segment 1200 to bend along a direction perpendicular to the axial plane of the first axial bending resistance region 1210. When the outer tube's bendable region 1220 and the first axial bending resistance region 1210 form different distributions on the surface of the bending outer tube segment 1200, the bending outer tube segment 1200 can be defined with a specific bendable direction. Those skilled in the art can design according to their needs, but no limitation is made here.
[0106] The bent outer pipe section 1200 may have one or more bendable regions 1220, as long as the bending direction of the bent outer pipe section 1200 can be met as required. For example, see [reference needed]. Figures 8 to 10 As shown, in one embodiment, the bent outer pipe section 1200 has two bendable outer pipe regions 1220, which are symmetrical with respect to the central axis of the bent outer pipe section 1200. In this case, the bent outer pipe section 1200 can be bent by relying on the bendable outer pipe regions 1220. The bendable outer pipe regions 1220 can be used in various ways to facilitate the bending of the bent outer pipe section 1200. For example, the bendable outer pipe regions 1220 can be made of a bendable material, or they can be implemented using a bendable structure; no limitation is made here.
[0107] See Figure 8As shown, in one embodiment, a plurality of first hollow holes 1221 are provided in the bendable region 1220 of the outer tube. The first hollow hole 1221 includes a first arc-shaped hole 1221a and two first circular holes 1221b located at both ends of the first arc-shaped hole 1221a. The first arc-shaped hole 1221a extends circumferentially and is perpendicular to the central axis of the bent outer tube segment 1200. The plurality of first hollow holes 1221 are arranged along the axial direction of the bent outer tube segment 1200. The region between the two bendable regions 1220 of the outer tube forms a first axial bending resistance region 1210.
[0108] The first perforated hole 1221 can be formed by cutting nickel-titanium alloy. The first perforated holes 1221 in the two bendable areas 1220 of the outer tube can adopt the same cut shape and be symmetrically arranged and extended along the axial direction. The area between the two bendable areas 1220 of the outer tube forms the first axial bending resistance area 1210. At this time, the first axial bending resistance area 1210 mainly manifests as the uncut area on the surface of the bent outer tube section 1200. The remaining area forms a symmetrical double rib, that is, the symmetrical first axial bending resistance area 1210. The double rib direction has good compressive strength and the direction perpendicular to the double rib plane has excellent bending performance.
[0109] Among them, the two first circular holes 1221b at both ends of the first arc-shaped hole 1221a enable the outer pipe section 1200 to expand and compress a larger stroke when the pipe is bent, weakening the influence of the double ribs on the bending, making the bending angle larger and the bending less strenuous. At the same time, due to the reinforcement and support of the double ribs on both sides, the outer pipe section 1200 will not kink or overlap even when it is stretched and compressed by axial force, and the stability of the outer pipe section 1200 is better.
[0110] Continue reading Figure 9 As shown, in one embodiment, a plurality of second arc-shaped holes 1222 extending circumferentially are provided in the bendable region 1220 of the outer tube. The second arc-shaped holes 1222 are perpendicular to the central axis of the bent outer tube segment 1200, and the plurality of second arc-shaped holes 1222 are arranged along the axial direction of the bent outer tube segment 1200. At least two axial straight holes 1222a extending axially are provided in the first axial bending resistance region 1210. The two axial straight holes 1222a form a bending resistance rib to resist the bending of the bent outer tube segment 1200.
[0111] The second arc-shaped hole 1222 and the axial straight hole 1222a can be cut using nickel-titanium alloy. The second arc-shaped holes 1222 in the two bendable areas 1220 of the outer tube can adopt the same cut shape and be symmetrically arranged and extended along the axial direction. The area between the two bendable areas 1220 of the outer tube forms the first axial bending resistance area 1210. At this time, the first axial bending resistance area 1210 mainly manifests as the uncut area on the surface of the bent outer tube section 1200, forming a symmetrical double rib, i.e., the symmetrical first axial bending resistance area 1210. At least two axial straight holes 1222a extending along the axial direction are also opened in the area. The axial straight holes 1222a can include multiple unit straight holes distributed axially.
[0112] Continue reading Figure 10 As shown, in one embodiment, a plurality of arc-shaped notches 1223 extending circumferentially are formed within the bendable region 1220 of the outer pipe. The arc-shaped notches 1223 are perpendicular to the central axis of the bent outer pipe section 1200, and the plurality of arc-shaped notches 1223 are arranged along the axial direction of the bent outer pipe section 1200. The plurality of arc-shaped notches 1223 located within two bendable regions 1220 of the outer pipe have partially intersecting groove segments in the circumferential direction, particularly referring to... Figure 10 As shown, the arc-shaped cut grooves 1223 in different bendable areas 1220 of the outer tube are staggered one-to-one in the axial direction. That is, two axially adjacent arc-shaped cut grooves 1223 in the same bendable area 1220 of the outer tube are staggered with arc-shaped cut grooves 1223 in another bendable area 1220 of the outer tube.
[0113] The diameter of the bent outer pipe section 1200 can be larger than that of the pushing outer pipe section 1300. When the bent outer pipe section 1200 is actively bent using methods such as the traction wire 3000, because its diameter is larger than that of the pushing outer pipe section 1300, the larger diameter of the bent outer pipe section 1200 can generate a larger moment perpendicular to its cross-section, thus achieving a good bending control effect. In other words, by increasing the outer diameter of the bent outer pipe section 1200 relative to the pushing outer pipe section 1300, a larger bending angle can be generated in the outer conduit 1000. (See reference...) Figure 6 As shown, in one embodiment, the proximal end of the curved outer pipe section 1200 has a variable diameter section, which is connected to the distal end of the pushing outer pipe section 1300. The diameter of the variable diameter section of the curved outer pipe section 1200 gradually decreases from the distal end to the proximal end, thus forming a transitional connection between the curved outer pipe section 1200 and the pushing outer pipe section 1300 with different pipe diameters.
[0114] See Figure 11 and Figure 12As shown, the outer layer of the bent outer pipe section 1200 has an outer outer pipe layer 1100a, and the inner layer of the bent outer pipe section 1200 has an inner outer pipe layer 1100b. The main pipe layer 1100 can be made of metal-cut reinforced pipe, such as stainless steel 316, 304, or nickel-titanium alloy, etc. The outer outer pipe layer 1100a can be coated with a polymer material, such as Pebax, polyamide, TSPU, etc., and the inner outer pipe layer 1100b can also be coated with a polymer material, such as PTFE, high-density polyethylene, etc. Those skilled in the art can choose appropriate materials according to their needs, and no limitation is made here.
[0115] Continue reading Figure 6 and Figure 7 As shown, this application also provides a delivery assembly, which includes an outer catheter 1000, an inner catheter 2000, a traction wire 3000, and a stent body. The inner catheter 2000 has a guiding lumen 2100d and is movably mounted in the axial lumen of the outer catheter 1000. The traction wire 3000 is connected to at least one of the outer catheter 1000 and the inner catheter 2000. A valve is mounted on the stent body, and the stent body and the valve are configured for mounting between the inner catheter 2000 and the outer catheter 1000. In one embodiment, the inner catheter 2000 may also include a curved inner tube segment 2100 and a pushing inner tube segment 2200 in the axial direction. The proximal end of the curved inner tube segment 2100 is connected to the distal end of the pushing inner tube segment 2200, and an axial bending resistance region 2110 of the inner tube may be provided on the curved inner tube segment 2100.
[0116] The inner catheter 2000 is movably fitted within the axial lumen of the outer catheter 1000. This is primarily manifested in the fact that the inner catheter 2000 can move axially relative to the outer catheter 1000 within its axial lumen. A stent with a valve can be directly or indirectly fitted between the inner catheter 2000 and the outer catheter 1000. It should be noted that the axial direction mentioned above refers to the direction of the central axis of either the outer catheter 1000 or the inner catheter 2000. Figure 6 and Figure 7 The left and right directions shown refer to the circumferential direction, which is the direction around the central axis of the external catheter 1000 or the internal catheter 2000.
[0117] The traction wire 3000 can be connected to any position of the outer conduit 1000 or the inner conduit 2000. For example, in one embodiment, the distal end of the traction wire 3000 is connected to the distal end of the inner conduit 2000, such as the distal end of the traction wire 3000 being connected to the distal end of the curved inner tube segment 2100. Those skilled in the art can adjust the connection position of the traction wire 3000 and the curved inner tube segment 2100 according to the bending control requirements of the inner conduit 2000. Alternatively, those skilled in the art can also choose to connect the traction wire 3000 to the outer conduit 1000 as needed, such as connecting it to the curved outer tube segment 1200 of the outer conduit 1000. This is not limited here.
[0118] Once the connection position between the traction wire 3000 and the inner catheter 2000 is determined, pulling the traction wire 3000 will pull on the corresponding position of the inner catheter 2000, causing it to bend. The traction wire 3000 can be directly or indirectly connected to the inner catheter 2000, for example, by binding, wrapping, or welding, or refer to [reference needed]. Figure 6 And see Figures 13 to 15 As shown, a support fixing member 4000 is provided on the inner conduit 2000. The support fixing member 4000 can be located at the distal end of the inner conduit 2000, such as at the distal end of the curved inner tube section 2100. The traction wire 3000 can be indirectly connected to the inner conduit 2000 through the support fixing member 4000. The position of the support fixing member 4000 on the inner conduit 2000 is the position where the traction wire 3000 is connected on the inner conduit 2000. The support fixing member 4000 has a wire fixing part 4200, which is used to specifically connect the traction wire 3000. The support fixing member 4000 may also have an inner cavity 4100, which communicates with the guide inner cavity 2100d. A guide wire can be passed through the inner cavity 4100 and the guide inner cavity 2100d. The guide wire is used to guide the forward direction of the delivery component.
[0119] When the inner catheter 2000 bends, for example, when the inner catheter 2000 bends in the bent inner segment 2100, the inner catheter 2000 transmits a bending force to the outer catheter 1000. Because the first axial bending resistance region 1210 and the second axial bending resistance region 1310 of the outer catheter 1000 are misaligned at a certain circumferential angle, the bent outer segment 1200 and the pushing outer segment 1300 of the outer catheter 1000 can bend in different planes, thereby realizing the flexible bending of the outer catheter 1000 in three-dimensional space. It can smoothly pass through lumens such as aortic arches of different shapes in the body. Moreover, based on the active bending control of the outer catheter 1000 in three-dimensional space, it can also ensure that the human valve annulus and aortic arch are in the same plane, which facilitates coaxial adjustment and release of valve stents, effectively improving the surgical outcome.
[0120] Continue reading Figure 6 As shown, the inner catheter 2000 can be connected to the inner core tube 5000. The inner core tube 5000 has a core tube lumen, and its proximal end can communicate with the distal end of the inner catheter 2000. Guide wires can be threaded through the guide lumen 2100d and the core tube lumen. These guide wires guide the direction of the delivery assembly. At this time, the stent body can be fitted onto the inner core tube 5000, thus assembling it between the inner catheter 2000 and the outer catheter 1000. (See reference...) Figure 15 As shown, the support fixing component 4000 has a support fixing part 4300. The support fixing part 4300 can adopt various structural forms such as a groove structure or a through hole structure, as long as the support fixing part 4300 can fix the support body. Moreover, the shape of the groove structure and the through hole structure can be matched with the connecting structure such as the lugs on the support body to facilitate the stable assembly of the support body. When the support body with the valve is fixed, the support fixing part 4300 can restrict the movement of the support body, such as restricting the movement of the support body in the circumferential and axial directions. The distal end of the inner core tube 5000 can be provided with a distal guide 4400. The distal guide 4400 can have a conical head or other structure to facilitate the advancement of the entire delivery assembly.
[0121] The inner conduit 2000 can be bent in all directions or its bending direction can be predetermined as needed. For example, in one embodiment, the axial segment of the inner conduit 2000 can also have an axially extending axially resisting region 2110. The axially resisting region 2110 can occupy at least a portion or all of the axial segment of the inner conduit 2000. The axially resisting region 2110 is mainly manifested as a linear region extending along the axial direction, and the width of the linear region can be set according to actual needs, so that the axially resisting region 2110 can resist the bending of the inner conduit 2000 along the axial plane where the axially resisting region 2110 is located. The inner conduit 2000 can be straight in the non-use state and non-straight in the use state. Therefore, the axial direction of the inner conduit 2000 can be a straight trajectory or a curved trajectory in the straight state and non-straight state, respectively. Correspondingly, the axially extending axially resisting region 2110 also forms a straight trajectory or a curved trajectory in different states.
[0122] It should be noted that the axial plane refers to the plane containing the central axis. Therefore, the axial plane where the inner tube axial bending resistance region 2110 is located means that the plane passes through both the central axis of the inner tube 2000 and the inner tube axial bending resistance region 2110 on the surface of the inner tube 2000. It resists the bending of the inner tube 2000 along the axial plane where the inner tube axial bending resistance region 2110 is located, that is, it means that the inner tube 2000 cannot bend smoothly along the axial plane, or even that the inner tube 2000 cannot bend along the axial plane at all.
[0123] The inner catheter 2000 may have one or more axial bending resistance regions 2110, as long as the bending direction of the inner catheter 2000 can be restricted as needed. For example, see [reference needed]. Figures 16 to 18 As shown, in one embodiment, the inner conduit 2000 has two inner tube axial bending resistance regions 2110, such as mainly in the curved inner tube section 2100 of the inner conduit 2000, the two inner tube axial bending resistance regions 2110 are symmetrical with respect to the central axis of the inner conduit 2000, in which case the inner conduit 2000 can only be bent along the direction perpendicular to the plane of the axis where the two inner tube axial bending resistance regions 2110 are located.
[0124] The traction wire 3000 can pull the inner catheter 2000 in various ways, for example, in one embodiment, see [reference]. Figure 19 As shown, the traction wire 3000 is inserted into the guide cavity 2100d of the inner conduit 2000. When the traction wire 3000 is pulled, its free arrangement allows it to adhere closely to the inner wall surface of the controlled bend side of the guide cavity 2100d under stress. Alternatively, refer to... Figure 20 and Figure 21 As shown, at least a portion of the axial section of the inner catheter 2000 has a traction channel 2130, and the traction wire 3000 is inserted in the traction channel 2130 of the inner catheter 2000. The vertical distance between the traction channel 2130 and the central axis of the inner catheter 2000 is greater than the radius of the inner catheter 2000.
[0125] Continue reading Figure 20 and Figure 21As shown, the bent inner tube segment 2100 may include an outer inner tube layer 2100a, an inner inner tube layer 2100b, and a reinforcing tube layer 2100c located between the outer inner tube layer 2100a and the inner inner tube layer 2100b. The reinforcing tube layer 2100c may be made of medical-grade stainless steel braided metal or a reinforced metal tube material that is tensile and easily bent; the reinforced metal tube material may be nickel-titanium tubing or stainless steel. The inner inner tube layer 2100b may be made of a low-friction material, such as PTFE or HDPE, while the outer inner tube layer 2100a may be made of a medical-grade polymer material, such as Pebax or PA. A traction channel 2130 may be provided between the outer inner tube layer 2100a and the reinforcing tube layer 2100c, and a traction wire 3000 may be arranged between the outer inner tube layer 2100a and the reinforcing tube layer 2100c; bending can be achieved by applying force to the distal end of the traction wire 3000. Alternatively, a traction channel 2130 may be provided on the inner wall of the inner tube inner layer 2100b.
[0126] In one embodiment, the surface of the bent inner tube segment 2100 has an axially extending bendable region 2120. The bendable region 2120 does not intersect with the axial plane of the inner tube axial resistance region 2110, so that the bent inner tube segment 2100 mainly relies on the bendable region 2120 for bending, while the bending is restricted by the axial resistance region 2110. For example, the bendable region 2120 is used to at least allow the bent inner tube segment 2100 to bend in a direction perpendicular to the axial plane of the inner tube axial resistance region 2110. When the bendable region 2120 and the axial resistance region 2110 are distributed differently on the surface of the bent inner tube segment 2100, the bent inner tube segment 2100 can be defined with a specific bendable direction. Those skilled in the art can design according to their needs, but no limitation is made here.
[0127] The bent outer pipe section 1200 may have one or more bendable regions 1220, as long as the bending direction of the bent outer pipe section 1200 can be met as required. For example, see [reference needed]. Figures 16 to 18 As shown, in one embodiment, the bent inner tube segment 2100 has two bendable inner tube regions 2120, which are symmetrical with respect to the central axis of the bent inner tube segment 2100. In this case, the bent inner tube segment 2100 can be bent by relying on the bendable inner tube regions 2120. The bendable inner tube regions 2120 can be used in various ways to facilitate the bending of the bent inner tube segment 2100. For example, the bendable inner tube regions 2120 of the bent inner tube segment 2100 can be made of a bendable material, or the bendable inner tube regions 2120 of the bent inner tube segment 2100 can be implemented using a bendable structure; no limitation is made here.
[0128] See Figure 16As shown, multiple second hollow holes 2121 are provided in the bendable area 2120 of the inner tube. The second hollow holes 2121 include a third arc-shaped hole 2121a and two second circular holes 2121b located at both ends of the third arc-shaped hole 2121a. The third arc-shaped hole 2121a extends circumferentially and is perpendicular to the central axis of the bent inner tube section 2100. The multiple second hollow holes 2121 are arranged along the axial direction of the bent inner tube section 2100. The area between the two bendable areas 2120 of the inner tube forms the axial bending resistance area 2110 of the inner tube.
[0129] The second hollow hole 2121 can be formed by cutting nickel-titanium alloy. The second hollow holes 2121 in the two bendable areas 2120 of the inner tube can adopt the same cut shape and be symmetrically arranged and extended along the axial direction. The area between the two bendable areas 2120 of the inner tube forms the axial bending resistance area 2110 of the inner tube. At this time, the axial bending resistance area 2110 of the inner tube mainly manifests as the uncut area on the surface of the bent inner tube section 2100. The remaining area forms a symmetrical double rib, that is, the symmetrical axial bending resistance area 2110 of the inner tube. The double rib direction has good compressive strength and the direction perpendicular to the double rib plane has excellent bending performance.
[0130] Among them, the two second circular holes 2121b at both ends of the third arc-shaped hole 2121a enable the curved inner pipe section 2100 to expand and compress a larger stroke when the pipe bends, weakening the influence of the double ribs on the bending, making the bending angle larger and the bending less strenuous. At the same time, due to the reinforcement and support of the double ribs on both sides, the curved inner pipe section 2100 will not kink or overlap when subjected to axial force for stretching and compression, and the stability of the curved inner pipe section 2100 is better.
[0131] See Figure 17 and Figure 18 As shown, the curved inner tube segment 2100 includes multiple rotatably connected unit joints 2122 along its axial direction. There is a fixed axis transition portion 2122a between adjacent unit joints 2122. The fixed axis transition portion 2122a is located in the axial bending resistance region 2110 of the inner tube. The axial arrangement of the fixed axis transition portion 2122a resists the bending of the curved inner tube segment 2100. Moreover, there is a rotation gap 2122b between adjacent unit joints 2122. The rotation gap 2122b is located in the bending region 2120 of the inner tube. Due to the existence of the rotation gap 2122b, the bending of the curved inner tube segment 2100 can be satisfied. Furthermore, the adjacent unit joints 2122 can overlap each other at the rotation gap 2122b.
[0132] Continue reading Figure 17As shown, in one embodiment, the fixed-axis adapter 2122a includes a rotating shaft and a shaft hole located on adjacent unit joint members 2122, allowing the adjacent unit joint members 2122 to rotate in a fixed-axis configuration via the rotating shaft and shaft hole. Alternatively, refer to... Figure 18 As shown, the fixed-axis transition part 2122a includes a first rotating fastening structure and a second rotating fastening structure located on the adjacent unit joint 2122. The first rotating fastening structure includes a first arc-shaped sliding groove 2122a1, a first arc-shaped fastening arm 2122a2, and a central fastening groove 2122a3. The second rotating fastening structure includes a second arc-shaped sliding groove 2122a4, a second arc-shaped fastening arm 2122a5, and a central fastening head 2122a6. The first arc-shaped fastening arm 2122a2 is slidably assembled along the second arc-shaped sliding groove 2122a4, and the second arc-shaped fastening arm 2122a5 is slidably assembled along the first arc-shaped sliding groove 2122a1. The central fastening head 2122a6 and the central fastening groove 2122a3 are rotatably assembled. The central fastening head 2122a6 and the central fastening groove 2122a3 can be interlocked when subjected to force, making them less likely to break.
[0133] A conveying system includes an outer conduit 1000; or, the conveying system includes a conveying assembly. Since the specific structure, functional principles, and technical effects of the outer conduit 1000 and the conveying assembly have been detailed above, they will not be repeated here. Any technical information regarding the outer conduit 1000 and the conveying assembly can be found in the preceding description.
[0134] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0135] The above embodiments merely illustrate several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.
Claims
1. A delivery assembly characterized by, The conveying assembly includes: An external conduit includes a main tube layer with an axial inner cavity. The main tube layer includes a curved outer tube segment and a pushing outer tube segment in the axial direction. The curved outer tube segment has a first axially extending anti-bending region for resisting bending of the curved outer tube segment along the axial plane where the first axially extending anti-bending region is located. The pushing outer tube segment has a second axially extending anti-bending region for resisting bending of the pushing outer tube segment along the axial plane where the second axially extending anti-bending region is located. An angle can be formed between the axial plane where the first axially extending anti-bending region is located and the axial plane where the second axially extending anti-bending region is located. An inner catheter having a guiding lumen, the inner catheter being movably fitted within the axial lumen of an outer catheter, at least a portion of the axial segment of the inner catheter having an axially extending axial bending-resistant region, the axial bending-resistant region being used to resist bending of the inner catheter along the axial plane where the axial bending-resistant region is located. A traction wire, which is connected to at least one of the outer conduit and the inner conduit.
2. The conveying assembly according to claim 1, characterized in that, The curved outer tube section and the pushing outer tube section are integrally formed, with the proximal end of the curved outer tube section fixedly connected to the distal end of the pushing outer tube section; or, The curved outer tube segment and the pushing outer tube segment are separate structures. The proximal end of the curved outer tube segment is rotatably connected to the distal end of the pushing outer tube segment. Based on the fixed-axis rotation between the curved outer tube segment and the pushing outer tube segment, the plane angle between the axial plane where the first axial bending region is located and the axial plane where the second axial bending region is located can be adjusted.
3. The conveying assembly according to claim 2, characterized in that, The proximal end of the curved outer tube section and the distal end of the pushing outer tube section are respectively provided with a cooperating steering adjustment hole and a corner locking component. The steering adjustment hole is opened along the circumferential direction, and the corner locking component slides along the steering adjustment hole to adjust the fixed axis rotation angle between the curved outer tube section and the pushing outer tube section.
4. The conveying assembly according to claim 1, characterized in that, The curved outer pipe section has two first axial bending resistance regions, and the two first axial bending resistance regions are symmetrical with respect to the central axis of the curved outer pipe section; and / or The outer push tube segment has two second axial bending resistance regions, which are symmetrical with respect to the central axis of the outer push tube segment.
5. The conveying assembly according to claim 1, characterized in that, The surface of the curved outer pipe section has an axially extending bendable region, which does not intersect with the axial plane where the first axial bending resistance region is located. The bendable region is designed to allow the curved outer pipe section to bend in a direction perpendicular to the axial plane where the first axial bending resistance region is located.
6. The conveying assembly according to claim 5, characterized in that, The curved outer pipe section has two bendable regions, which are symmetrical with respect to the central axis of the curved outer pipe section.
7. The conveying assembly according to claim 6, characterized in that, Multiple first hollow holes are provided in the bendable area of the outer tube. Each first hollow hole includes a first arc-shaped hole and two first circular holes located at both ends of the first arc-shaped hole. The first arc-shaped hole extends circumferentially and is perpendicular to the central axis of the bendable outer tube segment. The multiple first hollow holes are arranged along the axial direction of the bendable outer tube segment. The area between the two bendable areas of the outer tube forms the first axial bending resistance area.
8. The conveying assembly according to claim 6, characterized in that, The outer tube has multiple second arc-shaped holes extending circumferentially within its bendable region. These second arc-shaped holes are perpendicular to the central axis of the bent outer tube segment, and are arranged axially along the bent outer tube segment; and / or, At least two axial straight holes extending along the axial direction are provided in the first axial bending region, and bending ribs for resisting bending of the bent outer pipe section are constructed between the two axial straight holes.
9. The conveying assembly according to claim 8, characterized in that, The axial straight hole includes multiple unit straight holes that are axially spaced apart.
10. The conveying assembly according to claim 6, characterized in that, Multiple arc-shaped notches extending circumferentially are provided in the bendable area of the outer pipe. The arc-shaped notches are perpendicular to the central axis of the bendable outer pipe segment, and the multiple arc-shaped notches are arranged along the axial direction of the bendable outer pipe segment. Among them, the multiple arc-shaped notches located in two bendable areas of the outer pipe have partially intersecting groove segments in the circumferential direction.
11. The conveying assembly according to claim 1, characterized in that, The proximal end of the curved outer tube section has a diameter-changing section, which is connected to the distal end of the pushing outer tube section. The diameter of the diameter-changing section of the curved outer tube section gradually decreases from the distal end to the proximal end; and / or, The outer layer of the curved outer pipe section has an outer outer pipe layer, and the inner layer of the curved outer pipe section has an inner outer pipe layer.
12. The conveying assembly according to claim 1, characterized in that, The conveying assembly includes: A stent body, on which a valve is fitted, the stent body and the valve being configured for fitting between the inner catheter and the outer catheter.
13. The conveying assembly according to claim 12, characterized in that, The conveying assembly includes: A support fixture, wherein the support fixture is disposed at the distal end of the inner conduit; and / or, The inner core tube has a core tube lumen, the proximal end of the inner core tube is connected to the distal end of the inner catheter, and at least one of the guide lumen and the core tube lumen is used to thread a guide wire.
14. The conveying assembly according to claim 13, characterized in that, The bracket fixing member has an inner cavity hole, which communicates with the guide cavity; and / or The bracket fastener has a wire fixing part; and / or, The bracket fastener has a bracket fixing part.
15. The conveying assembly according to claim 13, characterized in that, The distal end of the inner core tube is provided with a distal guide.
16. The conveying assembly according to claim 1, characterized in that, The inner tube has two axial bending resistance regions, which are symmetrical with respect to the central axis of the inner tube.
17. The conveying assembly according to claim 1, characterized in that, The inner conduit includes a curved inner tube segment and a pushing inner tube segment in the axial direction. The proximal end of the curved inner tube segment is connected to the distal end of the pushing inner tube segment. The axial bending resistance region of the inner tube is provided at least on the curved inner tube segment.
18. The conveying assembly according to claim 17, characterized in that, The distal end of the traction wire is connected to the distal end of the curved inner tube section; or, The traction wire is threaded through the guiding lumen of the inner catheter; or, At least a portion of the axial section of the inner catheter has a traction channel, and the traction wire is threaded through the traction channel of the inner catheter.
19. The conveying assembly according to claim 17, characterized in that, The curved inner tube section includes an outer inner tube layer, an inner inner tube layer, and a reinforcing tube layer located between the outer inner tube layer and the inner inner tube layer.
20. The conveying assembly according to claim 19, characterized in that, A traction channel is provided between the outer layer of the inner tube and the reinforcing tube layer; or, a traction channel is provided on the inner wall of the inner layer of the inner tube.
21. The conveying assembly according to claim 17, characterized in that, The surface of the curved inner tube segment has an axially extending bendable region, which does not intersect with the axial plane of the inner tube axial resistance region. The bendable region is designed to allow the curved inner tube segment to bend in a direction perpendicular to the axial plane of the inner tube axial resistance region.
22. The conveying assembly according to claim 21, characterized in that, The curved inner pipe section has two bendable regions, which are symmetrical with respect to the central axis of the curved inner pipe section.
23. The conveying assembly according to claim 22, characterized in that, Multiple second hollow holes are provided in the bendable area of the inner tube. The second hollow holes include a third arc-shaped hole and two second circular holes located at both ends of the third arc-shaped hole. The third arc-shaped hole extends circumferentially and is perpendicular to the central axis of the bendable inner tube segment. The multiple second hollow holes are arranged along the axial direction of the bendable inner tube segment. The area between the two bendable areas of the inner tube forms the axial bending resistance area of the inner tube.
24. The conveying assembly according to claim 22, characterized in that, The curved inner tube segment includes multiple rotatably connected unit joints along its axial direction. There is a fixed-axis transition part between adjacent unit joints. The fixed-axis transition part is located in the axial bending resistance region of the inner tube. There is a rotation gap between adjacent unit joints. The rotation gap is located in the bending easy region of the inner tube.
25. The conveying assembly according to claim 24, characterized in that, The fixed-axis transition part includes a rotating shaft and a shaft hole located on the adjacent unit joint; or... The fixed-axis adapter includes a first rotating fastening structure and a second rotating fastening structure located on adjacent unit joints. The first rotating fastening structure includes a first arc-shaped sliding groove, a first arc-shaped fastening arm, and a central fastening groove. The second rotating fastening structure includes a second arc-shaped sliding groove, a second arc-shaped fastening arm, and a central fastening head. The first arc-shaped fastening arm is slidably assembled along the second arc-shaped sliding groove, and the second arc-shaped fastening arm is slidably assembled along the first arc-shaped sliding groove. The central fastening head and the central fastening groove are rotatably assembled.
26. A conveying system, characterized in that, The conveying system includes the conveying component as described in any one of claims 1-25.