External catheter, transport assembly, and transport system

Abstract

This application relates to an external catheter, a delivery component, and a delivery system. The main catheter body has an axial lumen and includes an external catheter bendable section and an external catheter push section along the axial direction. The external catheter bendable section has a first axial bending resistance portion extending along the axial direction. The first axial bending resistance portion is configured to resist bending of the external catheter bendable section along the axial plane in which the first axial bending resistance portion is located. The external catheter push section has a second axial bending resistance portion extending along the axial direction. The second axial bending resistance portion is configured to resist bending of the external catheter push section along the axial plane in which the second axial bending resistance portion is located. An angle may be formed between the axial planes of the first and second axial bending resistance portions. This configuration creates a circumferential angular misalignment between the first and second axial bending resistance portions of the external catheter, allowing them to bend in different planes, enabling three-dimensional bending of the external catheter and smooth passage through various vascular lumens of various shapes within the body.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly, to outer catheters, delivery components, and delivery systems.

Background Art

[0002] Heart valve replacements such as aortic valve replacement, mitral valve replacement, tricuspid valve replacement, and pulmonary valve replacement involve delivering, positioning, and releasing an artificial valve through a catheter of a delivery system to replace the native valve. In recent years, this technology has attracted wide attention in the field of heart valve disease treatment. For example, transcatheter aortic valve replacement (TAVR) can be used to treat aortic valve diseases without causing significant mental trauma to the patient and without open chest surgery and cardiac arrest.

[0003] The catheters of existing delivery systems used in the TAVR technique cannot be actively three-dimensionally maneuvered. When advancing through the aortic arch, the catheter of the delivery system utilizes passive bending due to the reaction force from the blood vessel wall, thereby advancing through the aortic arch. However, this may cause some damage to the blood vessel wall and may lead to certain vascular complications in some cases. Furthermore, during subsequent valve crossing and coaxial adjustment of TAVR, the lack of active maneuverability of the catheter of the delivery system makes it difficult to ensure that the annulus is on the same plane as the aortic arch. This makes coaxial adjustment difficult and affects valve release and fixation.

[0004] Therefore, how to achieve accurate coaxial release of the valve stent inside the three-dimensional arch through controllable 3D space bending control still remains an important technical issue in this field.

Summary of the Invention

Problems to be Solved by the Invention

[0005] In light of the above issues, it would be desirable to provide an external catheter, delivery components, and a delivery system. [Means for solving the problem]

[0006] The external catheter for use in the delivery system is The catheter comprises a main catheter body having an axial lumen, the main catheter body comprising an outer catheter bendable section and an outer catheter push section along the axial direction, the outer catheter bendable section comprising a first axial bending resistance portion extending along the axial direction, the first axial bending resistance portion configured to resist bending of the outer catheter bendable section along the axial plane on which the first axial bending resistance portion is located, the outer catheter push section comprising a second axial bending resistance portion extending along the axial direction, the second axial bending resistance portion configured to resist bending of the outer catheter push section along the axial plane on which the second axial bending resistance portion is located, and an angle is formed between the axial plane on which the first axial bending resistance portion is located and the axial plane on which the second axial bending resistance portion is located.

[0007] In one embodiment, the outer catheter bendable section and the outer catheter push section are integrally formed structures, and the proximal end of the outer catheter bendable section is fixedly joined to the distal end of the outer catheter push section.

[0008] Alternatively, the outer catheter bendable section and the outer catheter push section are separate structures, with the proximal end of the outer catheter bendable section rotatably connected to the distal end of the outer catheter push section, and the plane angle between the axial plane where the first axial bending resistance portion is located and the axial plane where the second axial bending resistance portion is located is adjustable based on the fixed axis rotation between the outer catheter bendable section and the outer catheter push section.

[0009] In one embodiment, a pivot adjustment slot and a mating pivot locking element are provided at the proximal end of the outer catheter bendable section and the distal end of the outer catheter push section, respectively. The pivot adjustment slot extends circumferentially, and the pivot locking element slides along the pivot adjustment slot to adjust the angle of fixed axis rotation between the outer catheter bendable section and the outer catheter push section.

[0010] In one embodiment, the outer catheter bendable section has two first axial bending resistance portions that are symmetrical with respect to the central axis of the outer catheter bendable section.

[0011] Alternatively or additionally, the outer catheter push section has two second axial bending resistance sections that are symmetrical with respect to the central axis of the outer catheter push section.

[0012] In one embodiment, the surface of the outer catheter bendable section may include an outer catheter bending facilitating portion extending along the axial direction, wherein the outer catheter bending facilitating portion does not overlap with the axial plane on which the first axial bending resistance portion is located, and the outer catheter bending facilitating portion is configured to at least enable the outer catheter bendable section to bend along a direction perpendicular to the axial plane on which the first axial bending resistance portion is located.

[0013] In one embodiment, the flexible outer catheter section may be provided with two symmetrical outer catheter bending-facilitating portions that are symmetrical with respect to the central axis of the flexible outer catheter section.

[0014] In one embodiment, each of the outer catheter bending-facilitating portions may be provided with a plurality of first cavities, each comprising a first arc-shaped slot and two first circular slots located at both ends of the first arc-shaped slot, the first arc-shaped slot extending circumferentially and perpendicular to the central axis of the outer catheter bending-possible portion, the plurality of first cavities arranged along the axial direction of the outer catheter bending-possible portion, and the region between the two outer catheter bending-facilitating portions constitutes a first axial bending resistance portion.

[0015] In one embodiment, the portion of the outer catheter that facilitates bending may be provided with a plurality of second arc-shaped slots that extend circumferentially and are perpendicular to the central axis of the outer catheter bendable section, and the plurality of second arc-shaped slots are arranged along the axial direction of the outer catheter bendable section.

[0016] Alternatively or additionally, the first axial bending resistance portion may be provided with at least two lines of axially linear holes extending along the axial direction, and a bending resistance spinal portion for resisting bending of the lateral catheter bendable section may be provided between the two lines of axially linear holes.

[0017] In one embodiment, each line of the axially straight hole includes a plurality of hole units spaced apart in the axial direction.

[0018] In one embodiment, each of the portions that facilitate the bending of the outer catheter may be provided with a plurality of arc-shaped cutting grooves that extend circumferentially and are perpendicular to the central axis of the bendable portion of the outer catheter, and the plurality of arc-shaped cutting grooves are arranged along the axial direction of the bendable portion of the outer catheter, and the plurality of arc-shaped cutting grooves of the two portions that facilitate the bending of the outer catheter are partially alternate along the axial direction.

[0019] In one embodiment, the proximal end of the outer catheter bendable section is provided with a diameter-changing section that is connected to the distal end of the outer catheter push section, and the diameter of the diameter-changing section of the outer catheter push section gradually decreases from the distal end to the proximal end.

[0020] Alternatively or additionally, the flexible portion of the outer catheter may comprise an outer layer and an inner layer.

[0021] The delivery component is, The external catheter specified above, An inner catheter having a guide lumen, the inner catheter being movably attached within the axial lumen of an outer catheter, A pull wire coupled to at least one of the outer catheter and the inner catheter, A stent body to which a valve is attached, the stent body and the valve being configured to be attached between the inner catheter and the outer catheter,

[0022] In one embodiment, the delivery component A stent holder provided at the distal end of the inner catheter, and / or An inner core tube having a core tube lumen, the proximal end of the inner core tube communicating with the distal end of the inner catheter, and at least one of the guide lumen and the core tube lumen being configured to pass a guide wire therethrough,

[0023] In one embodiment, the stent holder may comprise an inner hole communicating with the guide lumen.

[0024] Alternatively or additionally, the stent holder may comprise a wire fastener.

[0025] Alternatively or additionally, the stent holder may comprise a stent holding member.

[0026] Alternatively or additionally, a distal guide member may be provided at the distal end of the inner core tube.

[0027] In one embodiment, at least one axial section of the inner catheter may comprise an inner catheter axial buckling resistance portion extending axially, the inner catheter axial buckling resistance portion being configured to resist buckling of the inner catheter along the axial plane in which the inner catheter axial buckling resistance portion is located.

[0028] In one embodiment, the inner catheter may comprise two inner catheter axial buckling resistance portions that are symmetric about the central axis of the inner catheter.

[0029] In one embodiment, the internal catheter may have an internal catheter bendable section and an internal catheter push section along the axial direction, the proximal end of the internal catheter bendable section being connected to the distal end of the internal catheter push section, and the internal catheter axial bending resistance portion being provided at least within the internal catheter bendable section.

[0030] In one embodiment, the distal end of the pull wire may be connected to the distal end of the flexible section of the internal catheter.

[0031] Alternatively, the pull wire may be passed through the guide lumen of the internal catheter.

[0032] Alternatively, at least one axial section of the inner catheter may be provided with a pull channel, through which a pull wire is passed.

[0033] In one embodiment, the flexible section of the inner catheter may include an outer layer of the inner catheter, an inner layer of the inner catheter, and a reinforcing layer between the outer layer and the inner layer of the inner catheter.

[0034] In one embodiment, a tension channel may be provided between the outer layer of the inner catheter and the reinforcing layer, or a tension channel may be provided in the inner wall of the inner layer of the inner catheter.

[0035] In one embodiment, the surface of the inner catheter bendable section may include an inner catheter bending facilitating portion that extends along the axial direction, the inner catheter bending facilitating portion not overlapping with the axial plane on which the inner catheter axial bending resistance portion is located, and the inner catheter bending facilitating portion is configured to at least enable the inner catheter bendable section to bend in a direction perpendicular to the axial plane on which the inner catheter axial bending resistance portion is located.

[0036] In one embodiment, the inner catheter bendable section may be provided with two inner catheter bending-facilitating portions that are symmetrical with respect to the central axis of the inner catheter bendable section.

[0037] In one embodiment, the portion that facilitates internal catheter bending may comprise a plurality of second cavities, each including a third arc-shaped slot and two second circular slots located at both ends of the third arc-shaped slot, wherein the third arc-shaped slot extends circumferentially and is perpendicular to the central axis of the internal catheter bending portion, the plurality of second cavities are arranged along the axial direction of the internal catheter bending portion, and the region between the two internal catheter bending facilitators constitutes the internal catheter axial bending resistance portion.

[0038] In one embodiment, the bendable section of the internal catheter may comprise a plurality of joint units articulated and rotatably connected along the axial direction, with a fixed axis pivot provided between adjacent joint units, the fixed axis pivot located in the portion of the internal catheter that resists axial bending, and a rotation gap provided between adjacent joint units, the rotation gap provided in the portion of the internal catheter that facilitates bending.

[0039] In one embodiment, the fixed shaft pivot portion comprises a shaft portion and a hole provided in the adjacent joining unit.

[0040] Alternatively, the fixed shaft pivot comprises a first rotatable engagement structure and a second rotatable engagement structure provided on adjacent joint units, wherein the first rotatable engagement structure comprises a first arc-shaped sliding slot, a first arc-shaped fastening arm, and a central fastening slot, and the second rotatable engagement structure comprises a second arc-shaped sliding slot, a second arc-shaped fastening arm, and a central fastening head, wherein the first arc-shaped fastening arm is slidably mounted along the second arc-shaped sliding slot, the second arc-shaped fastening arm is slidably mounted along the first arc-shaped sliding slot, and the central fastening head is rotatably mounted within the central fastening slot.

[0041] The delivery system is It comprises an external catheter as defined above, or a delivery component as defined above.

[0042] In the external catheter, delivery component, and delivery system defined above, a circumferential angular displacement is created between the first and second axial bending resistance portions of the external catheter, allowing the external catheter bendable section and external catheter push section to bend in different planes, respectively. This enables flexible three-dimensional bending of the external catheter and smooth passage through various lumens of different shapes within the body, such as the aortic arch. Based on the active three-dimensional maneuverability of the external catheter, the valve annulus can be maintained in the same plane as the aortic arch, facilitating coaxial adjustment and discharge of the valve stent, thereby significantly improving surgical outcomes. [Brief explanation of the drawing]

[0043] [Figure 1] This figure schematically shows an external catheter in a first bent configuration according to one embodiment of the present application. [Figure 2] This figure schematically shows an external catheter in a second bent configuration according to one embodiment of the present application. [Figure 3] This figure schematically shows the bending range of an external catheter according to one embodiment of the present application. [Figure 4] This figure schematically shows an outer catheter bendable section and an outer catheter push section that are circumferentially rotatable relative to each other at a certain angle, according to one embodiment of the present application. [Figure 5] This is a schematic plan view of the outer catheter bendable section and outer catheter pushing section of Figure 4, which are pivotable circumferentially relative to each other at a certain angle. [Figure 6] This is a schematic assembly diagram of an outer catheter and an inner catheter according to one embodiment of the present application. [Figure 7] This figure schematically shows an internal catheter according to one embodiment of the present application. [Figure 8] This figure schematically shows the flexible section of the outer catheter according to one embodiment of the present application. [Figure 9] This figure schematically shows the flexible section of the outer catheter according to another embodiment of the present application. [Figure 10] This figure schematically shows an external catheter bendable section according to yet another embodiment of the present application. [Figure 11] This figure schematically shows the main catheter body, the outer layer of the outer catheter, and the inner layer of the outer catheter according to one embodiment of this application. [Figure 12] This figure schematically shows the outer layer and inner layer of the inner catheter according to one embodiment of the present application. [Figure 13] This is a schematic perspective view of the internal catheter bendable section and stent holder according to one embodiment of the present application. [Figure 14] This is a schematic plan view of the internal catheter bendable section and stent holder according to one embodiment of the present application. [Figure 15] This figure schematically shows a stent holder according to one embodiment of the present application. [Figure 16] This figure schematically shows the bendable section of the internal catheter according to one embodiment of this application. [Figure 17] This figure schematically shows the internal catheter bendable section according to another embodiment of the present application. [Figure 18] This figure schematically shows an internal catheter bendable section according to yet another embodiment of the present application. [Figure 19] This figure schematically shows a pull wire passed through a guide lumen according to yet another embodiment of the present application. [Figure 20] This figure schematically shows a pull wire passed through a tension channel according to one embodiment of the present application. [Figure 21] This figure schematically shows a pull wire passed through a tension channel according to another embodiment of the present application. [Modes for carrying out the invention]

[0044] The above-mentioned objectives, features, and advantages of this application will become clearer and easier to understand by reading the detailed description of some specific embodiments below with reference to the accompanying drawings. Numerous details are given in the following description to provide a complete understanding of this application. However, this application may be implemented in numerous other forms not described herein, and those skilled in the art can make similar improvements without departing from the spirit of the invention. Therefore, this application is not limited to the specific embodiments disclosed below.

[0045] It will be understood that terms such as “central,” “longitudinal,” “transverse,” “length,” “width,” “thickness,” “upper,” “lower,” “front,” “back,” “left,” “right,” “vertical,” “horizontal,” “upper,” “lower,” “inner,” “outer,” “clockwise,” “counterclockwise,” “axial,” “radial,” and “circumferential” may be used herein to describe directional or positional relationships based on the orientation shown in the figures. They are merely for the purpose of aiding and simplifying the description of this application and do not suggest or imply that the components or elements described have a particular orientation or must be constructed or operate in a particular orientation. Therefore, they should not be considered to limit this application.

[0046] In addition, as used herein, terms such as “first,” “second,” etc., are intended for illustrative purposes only and should not be interpreted as representing or suggesting relative importance or implicitly meaning the number of items being referred to. Therefore, designating an item as “first,” “second,” etc., is an explicit or implicit indication of the presence of one or at least two such items, unless the context clearly requires otherwise. As used herein, the word “plural” means “at least two,” such as two or three, unless otherwise clearly specified.

[0047] When used herein, unless otherwise clearly specified or defined, the words “attached,” “joined,” “connected,” “fixed,” and their variations should be interpreted in a broad sense. For example, connection may be permanent, removable, or integral connection, or mechanical or electrical connection, or direct or indirect connection using an intermediary medium, or internal communication or interaction between two elements. Those skilled in the art will be able to understand the specific meaning of the words described herein in the context of their use.

[0048] When used herein, unless otherwise clearly specified or defined, if a first feature is described as being "above" or "below" a second feature, it may be in direct contact with the second feature or indirectly in contact with it through an intervening medium. If a first feature is referred to as being "above," "above," or "above" a second feature, it may be immediately above, diagonally above, above, or above the second feature, or simply at a higher height than the second feature. If a first feature is referred to as being "below," "below," or "below" a second feature, it may be immediately below, diagonally below, below, or below the second feature, or simply at a lower height than the second feature.

[0049] When a component is referred to as being "fixed" or "positioned" to another component, it should be noted that this may be directly on top of the other component, or there may be an intervening component. When a component is referred to as being "connected" or "joined" to another component, it may be directly connected to or joined to the other component, or there may be an intervening component. As used herein, terms such as "vertical," "horizontal," "upper," "downward," "left," and "right" are for illustrative purposes only and do not represent the only possible implementation.

[0050] To more clearly describe the structure of the delivery component, as used herein, the term “distal end” refers to the end furthest from the operator during surgical procedures, and the term “proximal end” refers to the end closer to the operator. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to whom this application belongs. The terminology used herein is for the sole purpose of describing specific embodiments and is not intended to limit this application.

[0051] Referring to Figure 1, one embodiment of the present application provides an outer catheter 1000 for use in a delivery system. The outer catheter 1000 includes a main catheter body 1100 having an axial lumen. The main catheter body 1100 has an outer catheter bendable section 1200 and an outer catheter push section 1300 along its axis. The outer catheter bendable section 1200 has a first axial bending resistance portion 1210 extending along its axis. The first axial bending resistance portion 1210 is configured to resist bending of the outer catheter bendable section 1200 along the axial plane in which the first axial bending resistance portion 1210 is located. The outer catheter push section 1300 has a second axial bending resistance portion 1310 extending along its axis. The second axial bending resistance portion 1310 is configured to resist bending of the outer catheter push section 1300 along the axial plane in which the second axial bending resistance portion 1310 is located. The axial surfaces of the first and second axial bending resistance portions 1210 and 1310 may be at an angle to each other.

[0052] The first and second axial bending resistance portions 1210 and 1310 may basically be in the form of axially extending straight portions, each having a width that is not limited and can be appropriately determined according to the actual needs. Both the outer catheter bendable section 1200 and the outer catheter pushing section 1300 may be straight when not in use and may not be straight during use as shown in Figure 1. Therefore, in both axially straight and non-straight configurations, both the outer catheter bendable section 1200 and the outer catheter pushing section 1300, and thus the axially extending first and second axial bending resistance portions 1210 and 1310, may have a straight or curved trajectory.

[0053] It should be noted that the axial surfaces described above refer to surfaces passing through the corresponding central axis. In particular, the axial surface on which the first axial bending resistance portion 1210 is located is the surface passing through both the central axis and the surface of the outer catheter bendable section 1200, and "resisting bending of the outer catheter bendable section 1200 on the axial surface of the first axial bending resistance portion 1210" means that bending of the outer catheter bendable section 1200 on the axial surface is made difficult, or even impossible. Similarly, the axial surface on which the second axial bending resistance portion 1310 is located is the surface passing through both the central axis and the surface of the outer catheter push section 1300, and "resisting bending of the outer catheter push section 1300 on the axial surface of the second axial bending resistance portion 1310" means that bending of the outer catheter push section 1300 on the axial surface is made difficult, or even impossible.

[0054] By restricting the bending of the outer catheter bendable section 1200 and the outer catheter pushing section 1300 in the axial plane with the first and second axial bending resistance sections 1210 and 1310, respectively, it becomes possible to make them easier to bend in other directions where their bending is not restricted by the first and second axial bending resistance sections 1210 and 1310. Thus, a certain degree of selectivity in the bending direction is provided to the outer catheter bendable section 1200 and the inner catheter pushing section 2200.

[0055] Referring to Figure 1, a first axial bending resistance portion 1210 extending along the axis of the outer catheter bendable section 1200 is coupled to a second axial bending resistance portion 1310 extending along the axis of the outer catheter push section 1300. When there is no circumferential displacement between the first and second axial bending resistance portions 1210, 1310, the first and second axial bending resistance portions 1210, 1310 restrict the bending of the outer catheter bendable section 1200 and the outer catheter push section 1300 in the same direction. That is, the outer catheter bendable section 1200 and the outer catheter push section 1300 are allowed to bend in substantially a single direction, and their bending is substantially resisted in each of different single directions. When resisted while bending in essentially the same direction, the outer catheter bendable section 1200 and the outer catheter push section 1300 are two-dimensionally bendable within a plane.

[0056] Referring to Figure 2, when there is a circumferential angular displacement between the first and second axial bending resistance portions 1210 and 1310, the first and second axial bending resistance portions 1210 and 1310 restrict the bending of the outer catheter bendable section 1200 and the outer catheter push section 1300 in different directions. Therefore, the outer catheter bendable section 1200 and the outer catheter push section 1300 are not allowed to bend in a single direction, and their bending is resisted in different directions. Consequently, when subjected to equal tensile forces, the outer catheter bendable section 1200 and the outer catheter push section 1300 bend in different planes. As a result, the outer catheter bendable section 1200 and the outer catheter push section 1300 can bend three-dimensionally in space. Referring to Figure 3, the circumferential angle between the first and second axial bending resistance portions 1210, 1310 may be in the range of 1° to 90°, such as 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, etc., and this application is not limited to any particular such angle.

[0057] The outer catheter bendable section 1200 and the outer catheter push section 1300 may be separate structures, and the proximal end of the outer catheter bendable section 1200 may be rotatably coupled to the distal end of the outer catheter push section 1300. Based on the fixed axis rotation between the outer catheter bendable section 1200 and the outer catheter push section 1300, the plane angle between the axial planes in which the first and second axial bending resistance sections 1210, 1310 are located, i.e., the circumferential angle between the first and second axial bending resistance sections 1210, 1310, can be adjusted in the bending direction of the outer catheter bendable section 1200 and the outer catheter push section 1300 of the outer catheter 1000 in three-dimensional space. With this configuration, the outer catheter 1000 can be used for a wider range of applications for the treatment of various anatomically complex vascular lumens.

[0058] The rotatable connection between the outer catheter bendable section 1200 and the outer catheter push section 1300 may be achieved in various ways, such as by screw connections or snap-fit ​​connections. Referring to Figures 4 and 5, in one embodiment, a pivot adjustment slot 1200a and a mating pivot locking element 1200b are provided at the proximal end of the outer catheter bendable section 1200 and the distal end of the outer catheter push section 1300, respectively. The pivot adjustment slot 1200a extends circumferentially, and the pivot locking element 1200b is slidable along the pivot adjustment slot 1200a to adjust the angle of fixed axis rotation between the outer catheter bendable section 1200 and the outer catheter push section 1300. For example, the pivot adjustment slot 1200a may be provided at the proximal end of the outer catheter bendable section 1200, and the pivot locking element 1200b may be provided at the distal end of the outer catheter push section 1300. The distal end of the outer catheter pushing section 1300 may be pivotably nested within the proximal end of the outer catheter flexible section 1200 such that the pivot locking element 1200b protrudes outward through the pivot adjustment slot 1200a. The outer catheter flexible section 1200 and the outer catheter pushing section 1300 may be pivotable relative to each other about a fixed axis, thereby allowing the pivot locking element 1200b to slide along the pivot adjustment slot 1200a. When a desired angle is reached, the outer catheter flexible section 1200 and the outer catheter pushing section 1300 may be locked relative to each other by the pivot locking element 1200b.

[0059] The pivot adjustment slot 1200a may extend circumferentially over an angle of 1° to 90°. Without limitation, the pivot locking element 1200b may be a snap-fit ​​element, a threaded element, etc. In addition, a sealing element 1200c, such as a sealing ring, may be provided between the proximal end of the outer catheter bendable section 1200 and the distal end of the outer catheter push section 1300 to prevent blood from flowing out through the gap between the outer catheter bendable section 1200 and the outer catheter push section 1300 during surgery. For example, the pivot locking element 1200b may include a fastening screw and screw hole provided at the distal end of the outer catheter push section 1300, and a sealing ring groove may be provided at the distal end of the outer catheter push section 1300. The pivot adjustment slot 1200a may be provided at the proximal end of the outer catheter bendable section 1200 as a guide path. To assemble them together, first insert the distal end of the outer catheter push section 1300 into the proximal end of the outer catheter flexible section 1200 to create a nested structure. Then, insert the fastening screw into the pivot adjustment slot 1200a, not tightly, but slightly pre-screwed into the screw hole, so that the fastening screw can move freely within the pivot adjustment slot 1200a, allowing for smooth pivoting of the outer catheter push section and flexible sections 1300 and 1200 relative to each other. The fastening screw may always be maintained in the same orientation as the second axial bending resistance portion 1310 of the outer catheter push section 1300. The sealing ring may serve to prevent blood from flowing out through the gap between the outer catheter flexible section 1200 and the outer catheter push section 1300 during surgery.

[0060] Before surgery, the surgeon or medical professional may, as necessary, pivot the external catheter bendable section 1200 according to the patient's image to adjust the angle of circumferential displacement between the first axial bending resistance portion 1210 of the external catheter bendable section 1200 and the second axial bending resistance portion 1310 of the external catheter push section 1300, and then tighten the fastening screws. In this way, the delivery system can be bent in three dimensions at different angles under a bent state so that the curved shape of the delivery system conforms more closely to the arch in the patient's body.

[0061] Furthermore, in one embodiment, the outer catheter bendable section 1200 and the outer catheter push section 1300 may be integrally formed structures in which the proximal end of the outer catheter bendable section 1200 is fixedly joined to the distal end of the outer catheter push section 1300. In this case, the outer catheter bendable section 1200 and the outer catheter push section 1300 of the outer catheter 1000 are bent three-dimensionally relative to each other in a fixed direction. Therefore, catheters with different specifications are selected for surgical procedures based on practical needs.

[0062] The outer catheter 1000 may be used in a delivery system. For example, the outer catheter 1000 may be sleeved and assembled together with the inner catheter 2000 to form a delivery component used in a delivery system. Referring to Figures 6 and 7, the inner catheter 2000 is movably mounted within the axial lumen of the outer catheter 1000 and can be bent by a pull wire 3000 or the like, thereby causing the outer catheter 1000 to bend. In this configuration, under the action of the bending force transmitted from the inner catheter 2000 to the outer catheter 1000, the presence of a circumferential angular displacement between the first and second axial bending resistance portions 1210 and 1310 of the outer catheter 1000 as described above causes the outer catheter bendable section 1200 and the outer catheter push section 1300 of the outer catheter 1000 to bend in different planes, enabling flexible three-dimensional bending of the outer catheter 1000 and smooth passage through various shaped lumens in the body, such as the aortic arch. Furthermore, both the circumferential displacement angle and the active maneuvering angle, based on the active three-dimensional maneuverability of the external catheter 1000, determine the spatial orientation of the target object to be delivered, such as the valve and stent body. This allows the valve annulus to be maintained in the same plane as the aortic arch, facilitating coaxial adjustment and release of the valve stent, thereby significantly improving surgical outcomes.

[0063] The outer catheter bendable section 1200 may have one or more first axial bending resistance portions 1210, as long as the bending direction of the outer catheter bendable section 1200 is constrained as desired. For example, as shown in Figures 8 to 10, the outer catheter bendable section 1200 may have two first axial bending resistance portions 1210 that are symmetrical with respect to the central axis of the outer catheter bendable section 1200. In this configuration, the outer catheter bendable section 1200 can be bent only perpendicular to the axial plane on which the two first axial bending resistance portions 1210 are located. Similarly, the outer catheter push section 1300 may have one or more second axial bending resistance portions 1310, as long as the bending direction of the outer catheter push section 1300 is constrained as desired. For example, as shown in Figures 8 to 10, the outer catheter push section 1300 may have two second axial bending resistance portions 1310 that are symmetrical with respect to the central axis of the outer catheter push section 1300. In this configuration, the outer catheter pushing section 1300 can be bent only perpendicular to the axial plane in which the two second axial bending resistance sections 1310 are located.

[0064] Continuing to refer to Figures 8 to 10, in one embodiment, the outer catheter bending facilitating portion 1220 may be provided on the surface of the outer catheter bendable section 1200 along its axis. The outer catheter bending facilitating portion 1220 and the first axial bending resistance portion 1210 substantially cover the entire surface of the outer catheter bendable section 1200, and the present application is not limited to any particular proportion of the surface of the outer catheter bendable section 1200 they occupy. The outer catheter bending facilitating portion 1220 does not need to overlap with the axial plane of the first axial bending resistance portion 1210, such that the bending of the outer catheter bendable section 1200 basically relies on the outer catheter bending facilitating portion 1220, while being constrained by the first axial bending resistance portion 1210. For example, the outer catheter bending facilitating portion 1220 may at least allow the outer catheter bendable section 1200 to bend in a direction perpendicular to the axial plane on which the first axial bending resistance portion 1210 is located. Through different arrangements of the outer catheter bend-facing portion 1220 and the first axial bending resistance portion 1210 formed on the surface of the outer catheter bendable portion 1200, the outer catheter bendable portion 1200 can be configured to have a specific bending direction. Without limitation, those skilled in the art may design according to their own needs.

[0065] The outer catheter bendable section 1200 may have one or more outer catheter bend-facilitating portions 1220, insofar as the outer catheter bendable section 1200 can be bent in a desired direction. For example, as shown in Figures 8 to 10, in one embodiment, the outer catheter bendable section 1200 may have two outer catheter bend-facilitating portions 1220 that are symmetrical with respect to the central axis of the outer catheter bendable section 1200. In this configuration, the outer catheter bendable section 1200 is bendable because of the presence of the outer catheter bend-facilitating portions 1220. The outer catheter bend-facilitating portions 1220 may facilitate the bending of the outer catheter bendable section 1200 in various different ways. For example, the outer catheter bend-facilitating portions 1220 of the outer catheter bendable section 1200 may be made of a flexible material without limitation, or may be structured to be easily bent.

[0066] Referring to Figure 8, in one embodiment, the external catheter bending facilitating portion 1220 may include a plurality of first cavities 1221, each cavity including a first arc-shaped slot 1221a and two first circular slots 1221b located at both ends of the first arc-shaped slot 1221a. The first arc-shaped slot 1221a may extend circumferentially and be perpendicular to the central axis of the external catheter bending portion 1200, and the first cavities 1221 may be positioned along the axis of the external catheter bending portion 1200. A first axial bending resistance portion 1210 may be located between the two external catheter bending facilitating portions 1220.

[0067] The first cavity 1221 may be formed by machining a nickel-titanium alloy. The first cavities 1221 of the two external catheter flexibility-facilitating portions 1220 may use cutouts of the same shape, be symmetrically arranged with respect to each other, and extend along their axes. In this case, the region between the two external catheter flexibility-facilitating portions 1220 constitutes the first axial flexion-resistant portion 1210, which is the remaining uncut area of ​​the surface of the external catheter flexible section 1200, resulting in a symmetrical spine (symmetrical external catheter flexibility-facilitating portion 1220). The two spine provides both good compressive resistance in the direction in which they extend and excellent flexibility in the direction perpendicular to them.

[0068] Two first circular slots 1221b are provided at both ends of the first arc-shaped slot 1221a, which allow for greater elongation and compression of the lateral catheter bendable section 1200 during bending, and reduce the influence of the two vertebral sections on bending. As a result, this section can be bent more easily at a larger angle. Meanwhile, the two opposing vertebral sections provide reinforcement and support, giving the lateral catheter bendable section 1200 improved stability by preventing it from twisting or wrinkling when it is elongated or compressed axially.

[0069] Continuing to refer to Figure 9, in one embodiment, each external catheter bending-facilitating portion 1220 may include a plurality of second arc-shaped slots 1222, which extend circumferentially perpendicular to the central axis of the external catheter bending section 1200 and may be arranged along the axis of the external catheter bending section 1200. In addition, the first bending-resistance portion 1210 may include at least two lines of axial straight holes 1222a extending along the axis. A bending-resistance spine portion may be provided between adjacent lines of the axial straight holes 1222a to resist bending of the external catheter bending section 1200.

[0070] The second arc-shaped slot 1222 and the axial straight hole 1222a may be formed by machining a nickel-titanium alloy. The second arc-shaped slot 1222 of the two external catheter bending-facilitating portions 1220 may use cutouts of the same shape, be symmetrically arranged with respect to each other, and extend along their axes. The region between the two external catheter bending-facilitating portions 1220 constitutes the first axial bending-resistance portion 1210, which is the remaining uncut area of ​​the surface of the external catheter bending-flexible portion 1200, resulting in a symmetrical spine (symmetrical external catheter bending-facilitating portion 1220). At least two lines of the axial straight hole 1222a extending along the axis may be provided in this remaining region, and one line of the axial straight hole 1222a may consist of multiple axially spaced hole units.

[0071] Continuing to refer to Figure 10, in one embodiment, the outer catheter bending facilitating portion 1220 may include a plurality of arc-shaped cutting grooves 1223, which extend circumferentially, are perpendicular to the central axis of the outer catheter bending section 1200, and are arranged along the axis of the outer catheter bending section 1200. The plurality of arc-shaped cutting grooves 1223 of two outer catheter bending facilitating portions 1220 may be partially alternating along the axial direction. Referring particularly to Figure 10, the arc-shaped cutting grooves 1223 in one outer catheter bending facilitating portion 1220 may be axially alternating with the arc-shaped cutting grooves in the other outer catheter bending facilitating portion 1220. That is, the arc-shaped cutting grooves 1223 of the other outer catheter bending facilitating portion 1220 may be provided between axially adjacent arc-shaped cutting grooves 1223 in the same outer catheter bending facilitating portion 1220.

[0072] The outer catheter bendable section 1200 may have a larger diameter than the outer catheter push section 1300. In this configuration, when the outer catheter bendable section 1200 is actively bent by the pull wire 3000 or by other means, the outer catheter bendable section 1200, which has a larger diameter than the outer catheter push section 1300, can generate a torque perpendicular to the cross-section of the outer catheter bendable section 1200, thereby achieving good maneuvering control. That is, increasing the outer diameter of the outer catheter push section 1300 relative to the outer catheter bendable section 1200 makes it possible to maneuver the outer catheter 1000 at a larger angle. Referring to Figure 6, in one embodiment, the proximal end of the outer catheter bendable section 1200 may have a diameter change section that is connected to the distal end of the outer catheter push section 1300. The diameter of the diameter change section of the outer catheter bendable section 1200 may gradually decrease from distal to proximal. Therefore, a transitional connection is formed between the outer catheter bendable section 1200 and the outer catheter push section 1300, which have different diameters.

[0073] Referring to Figures 11 and 12, the flexible section 1200 of the outer catheter may include an outer layer 1100a and an inner layer 1100b. The main catheter body 1100 may be a reinforced metal tube obtained from a cutting process, and may be made from, for example, stainless steel 316 or 304, or a nickel-titanium alloy. The outer layer 1100a of the outer catheter may be provided with a polymer coating layer such as Pebax, polyamide (PA), or thermoplastic silicone polyether polyurethane (TSPU). The inner layer 1100b of the outer catheter may also be provided with a polymer coating layer such as polytetrafluoroethylene (PTFE) or high-density polyethylene (HDPE). Those skilled in the art can select the materials of these layers without limitation as suitable for practical needs.

[0074] Continuing with reference to Figures 6 and 7, a delivery component including the outer catheter 1000, inner catheter 2000, pull wire 3000, and stent body as defined above is also provided herein. The inner catheter 2000 has a guide lumen 2100d and is movably sleeved into the axial lumen of the outer catheter 1000. The pull wire 3000 is coupled to at least one of the outer catheter 1000 and the inner catheter 2000. A valve is attached to the stent body, and the stent body and valve are configured to be mounted between the inner catheter 2000 and the outer catheter 1000. In one embodiment, the inner catheter 2000 may similarly include an inner catheter bendable section 2100 and an inner catheter push section 2200 along its axis. The proximal end of the inner catheter bendable section 2100 is coupled to the distal end of the inner catheter push section 2200. The inner catheter bendable section 2100 may include an inner catheter axial bending resistance section 2110.

[0075] The inner catheter 2000 is sleeved to be movable within the axial lumen of the outer catheter 1000, and the inner catheter 2000 is movable axially relative to the outer catheter 1000 within the axial lumen of the outer catheter 1000. The stent body and the valve thereon may be attached directly or indirectly between the inner catheter 2000 and the outer catheter 1000. It should be noted that the terms “axial” and “in the axial direction” used above refer to the direction along the central axis of the outer catheter 1000 or inner catheter 2000, i.e., the left-right direction shown in Figures 6 and 7, while the terms “circumferential” and “circumferential direction” refer to the direction around the central axis of the outer catheter 1000 or inner catheter 2000.

[0076] The pull wire 3000 may be coupled to any desired location on the outer catheter 1000 or the inner catheter 2000. For example, in one embodiment, the distal end of the pull wire 3000 may be coupled to the distal end of the inner catheter 2000, for example, to the distal end of the inner catheter bendable section 2100. Those skilled in the art may couple the pull wire 3000 to a location on the inner catheter bendable section 2100 required for desired maneuverability of the inner catheter 2000, or, if desired, to the outer catheter 1000, for example, to the outer catheter bendable section 1200 of the outer catheter 1000. This application is not particularly limited in this regard.

[0077] Once the connection position between the pull wire 3000 and the inner catheter 2000 is determined, pulling the pull wire 3000 applies force to the aforementioned position on the inner catheter 2000, causing the inner catheter 2000 to bend. The pull wire 3000 may be directly or indirectly connected to the inner catheter 2000. For example, connecting the pull wire 3000 to the inner catheter 2000 may be achieved by tying, entanglement, welding, etc. Alternatively, referring to Figures 6 and 13 to 15, a stent holder 4000 may be provided on the inner catheter 2000, optionally at the distal end of the inner catheter 2000, for example, at the distal end of the inner catheter bendable section 2100. The pull wire 3000 can be indirectly connected to the inner catheter 2000 through the stent holder 4000. In this case, the position of the stent holder 4000 on the inner catheter 2000 is the connection position of the pull wire 3000 on the inner catheter 2000. The stent holder 4000 may have a wire fastener 4200 configured to connect the pull wire 3000 thereto. The stent holder 4000 may have an inner hole 4100 communicating with the guide lumen 2100d. A guide wire for guiding the advance of the delivery component in a certain direction may be passed through the inner hole 4100 and the guide lumen 2100d.

[0078] When the inner catheter 2000 is bent, for example, in the inner catheter bendable section 2100, it transmits force to the outer catheter 1000, which in turn causes the outer catheter 1000 to bend. Because there is a circumferential angular displacement between the first and second axial bending resistance sections 1210 and 1310 of the outer catheter 1000, the outer catheter bendable section 1200 and the outer catheter push section 1300 of the outer catheter 1000 bend in different planes, enabling flexible three-dimensional bending of the outer catheter 1000 and smooth passage through lumens of various shapes in the body, such as the aortic arch. Based on the active three-dimensional maneuverability of the outer catheter 1000, it is possible to maintain the valve annulus in the same plane as the aortic arch, facilitating coaxial adjustment and release of the valve stent, thereby significantly improving surgical outcomes.

[0079] Referring to Figure 6, the inner catheter 2000 may be coupled to an inner core tube 5000 having a core tube lumen, with the proximal end of the inner catheter 2000 communicating with the distal end of the inner catheter 2000. A guidewire for guiding the advancement of the delivery component in a certain direction may be passed through the guide lumen 2100d and the core tube lumen. In this case, the stent body may be sleeved on the inner core tube 5000, thereby between the inner catheter 2000 and the outer catheter 1000. Referring to Figure 15, the stent holder 4000 may include a stent retaining member 4300, which may have various different structures such as recesses or through-holes, insofar as they allow for the fixation of the stent body. In addition, to enable stable retention of the stent body, the recesses or through-holes may engage with connecting structures of the stent body, such as projections. Once the stent body and the valve on it are held, the stent retaining member 4300 can restrict the stent body from moving, for example, circumferentially, axially, or in other directions. A distal guide member 4400 may be provided at the distal end of the inner core tube 5000, which may be tapered or otherwise constructed to facilitate the advancement of the entire delivery component.

[0080] The internal catheter 2000 may be bendable in any desired direction, or only in a predetermined designated direction as needed. For example, in one embodiment, the internal catheter 2000 may also include an internal catheter axial bending resistance portion 2110, which may extend along the axis of the internal catheter 2000 for its entire axial length or at least a portion thereof. The internal catheter axial bending resistance portion 2110 may be in the form of a linear portion extending axially, which may have a width, which is determined as required by practical needs so that the internal catheter axial bending resistance portion 2110 can resist bending of the internal catheter 2000 along the axial plane in which the internal catheter axial bending resistance portion 2110 is located. The internal catheter 2000 may be straight when not in use and may not be straight when in use. Thus, in axially straight and non-straight configurations, the internal catheter 2000, and therefore the axially extending internal catheter axial bending resistance portion 2110, may have a linear or curved trajectory.

[0081] It should be noted that the axial plane mentioned above refers to the plane passing through the corresponding central axis. In particular, the axial plane on which the inner catheter axial bending resistance portion 2110 is located passes through both the central axis and the surface of the inner catheter 2000, and "resisting bending of the inner catheter 2000 along the axial plane on which the inner catheter axial bending resistance portion 2110 is located" means that bending of the inner catheter 2000 in the axial plane is made difficult, or even impossible.

[0082] The inner catheter 2000 may have one or more inner catheter axial bending resistance portions 2110, as required, insofar as they restrict the bending direction of the inner catheter 2000. For example, as shown in Figures 16 to 18, in one embodiment the inner catheter 2000 may have two inner catheter axial bending resistance portions 2110, which are symmetrical with respect to the central axis of the inner catheter 2000, and for example, both are essentially within the inner catheter bendable section 2100. In this configuration, the inner catheter 2000 can be bent only in directions perpendicular to the axial planes of the two inner catheter axial bending resistance portions 2110.

[0083] Pulling the inner catheter 2000 by the pull wire 3000 may be achieved in a variety of different ways. For example, in one embodiment, as shown in Figure 19, the pull wire 3000 may be passed through the guide lumen 2100d of the inner catheter 2000. In this case, the pull wire 3000 is positioned unfixed within the guide lumen 2100d, and when pulled, the tensed pull wire 3000 approaches the inner wall surface of the guide lumen 2100d on the manipulated side. Alternatively, as shown in Figures 20 and 21, at least one axial portion of the inner catheter 2000 may be provided with a pull channel 2130, and the pull wire 3000 may be passed through the pull channel 2130 of the inner catheter 2000. The vertical distance between the central axis of the pull channel 2130 and the central axis of the inner catheter 2000 may be greater than the radius of the inner catheter 2000.

[0084] Referring to Figures 20 and 21, the inner catheter bendable section 2100 may include an inner catheter outer layer 2100a, an inner catheter inner layer 2100b, and a reinforcing layer 2100c between the inner catheter outer layer 2100a and the inner layer 2100b. The reinforcing layer 2100c may be a braided stainless steel tube for medical use, or a reinforcing tube made from a metallic material with tensile strength and easy flexibility, such as nickel-titanium alloy or stainless steel. The inner catheter inner layer 2100b may be made from a low-friction material, such as PTFE or HDPE. The inner catheter outer layer 2100a may be made from a polymer material for medical use, such as Pebax or PA. A tension channel 2130, and therefore a pull wire 3000, may be positioned between the inner catheter outer layer 2100a and the reinforcing layer 2100c. In this configuration, maneuverability may be provided by applying force to the distal end of the pull wire 3000. Alternatively, the tension channel 2130 may be provided on the inner wall of the inner catheter inner layer 2100b.

[0085] In one embodiment, the inner catheter bendable section 2100 may include an axially extending inner catheter bending facilitating portion 2120, which does not necessarily have to overlap at all with the axial plane on which the inner catheter axial bending resistance portion 2110 is located, and allows the bending of the inner catheter bendable section 2100 to rely basically on the inner catheter bending facilitating portion 2120, while being constrained by the inner catheter axial bending resistance portion 2110. For example, the inner catheter bending facilitating portion 2120 may at least allow the inner catheter bendable section 2100 to bend in a direction perpendicular to the axial plane on which the inner catheter axial bending resistance portion 2110 is located. By forming different distributions of the inner catheter bending facilitating portion 2120 and the inner catheter axial bending resistance portion 2110 on the surface of the inner catheter bendable section 2100, the inner catheter bendable section 2100 can have a specific bending direction. Those skilled in the art may design according to their own needs without limitation.

[0086] The outer catheter bendable section 1200 may have one or more outer catheter bend-facilitating portions 1220, insofar as the outer catheter bendable section 1200 can be bent in a desired direction. For example, as shown in Figures 16 to 18, in one embodiment, the inner catheter bendable section 2100 may have two inner catheter bend-facilitating portions 2120 that are symmetrical with respect to the central axis of the inner catheter bendable section 2100. In this configuration, the inner catheter bendable section 2100 is bendable because of the presence of the inner catheter bend-facilitating portions 2120. The inner catheter bend-facilitating portions 2120 may facilitate the bending of the inner catheter bendable section 2100 in a variety of different ways. For example, the inner catheter bend-facilitating portions 2120 of the inner catheter bendable section 2100 may be made of a flexible material without limitation, or may be structured to be easily bent.

[0087] Referring to Figure 16, the internal catheter bending facilitating portion 2120 may include a plurality of second cavities 2121, each cavity including a third arc-shaped slot 2121a and two second circular slots 2121b located at both ends of the third arc-shaped slot 2121a. The third arc-shaped slot 2121a may extend circumferentially and be perpendicular to the central axis of the internal catheter bending portion 2100, and the plurality of second cavities 2121 may be arranged along the axis of the internal catheter bending portion 2100. The region between the two internal catheter bending facilitating portions 2120 constitutes the internal catheter axial bending resistance portion 2110.

[0088] The second cavity 2121 may be formed by machining a nickel-titanium alloy. The second cavities 2121 of the two internal catheter flexibility-facilitating portions 2120 may use cutouts of the same shape, be symmetrically arranged with respect to each other, and extend along their axes. In this case, the region between the two internal catheter flexibility-facilitating portions 2120 constitutes the internal catheter axial flexion resistance portion 2110, which is the remaining uncut area of ​​the surface of the internal catheter bendable portion 2100, resulting in a symmetrical spine (symmetrical internal catheter axial flexion resistance portion 2110). The two spines provide both good compressive resistance in the direction in which they extend and excellent flexibility in the direction perpendicular to them.

[0089] The ends of the third arc-shaped slot 2121a are provided with two second circular slots 2121b, which allow for greater elongation and compression of the internal catheter bendable section 2100 during flexion and reduce the influence of the two vertebral sections on flexion. As a result, this section becomes more easily bendable at larger angles. Meanwhile, the two opposing vertebral sections provide reinforcement and support, giving the internal catheter bendable section 2100 improved stability by preventing it from twisting or wrinkling when it is elongated or compressed axially.

[0090] Referring to Figures 17 and 18, the internal catheter bendable section 2100 may include a plurality of joint units 2122 that are articulated to be rotatably connected along its axis, and a fixed axis pivot 2122a between adjacent joint units 2122. The fixed axis pivot 2122a may be located in the internal catheter axial bending resistance section 2110, and the axial arrangement of the fixed axis pivot 2122a can be used to provide resistance to bending of the internal catheter bendable section 2100. In addition, there may be a rotation gap 2122b between adjacent joint units 2122, and the rotation gap 2122b may be located in the internal catheter bending facilitation section 2120. The presence of the rotation gap 2122b, along with the optional overlap of adjacent joint units 2122 in the rotation gap 2122b, allows for bending of the internal catheter bendable section 2100.

[0091] Continuing to refer to Figure 17, in one embodiment, the fixed shaft pivot 2122a may include a shaft and a hole in an adjacent joining unit 2122, and the joining unit 2122 may be articulated to be rotatable about a fixed shaft passing through this shaft and hole. Alternatively, continuing to refer to Figure 18, the fixed shaft pivot 2122a may include first and second rotatable engagement structures provided in each corresponding adjacent joining unit 2122. The first rotatable engagement structure may include a first arc-shaped sliding slot 2122a1, a first arc-shaped fastening arm 2122a2, and a central fastening slot 2122a3, and the second rotatable engagement structure may include a second arc-shaped sliding slot 2122a4, a second arc-shaped fastening arm 2122a5, and a central fastening head 2122a6. The first arc-shaped fastening arm 2122a2 may be slidably mounted along the second arc-shaped sliding slot 2122a4, the second arc-shaped fastening arm 2122a5 may be slidably mounted along the first arc-shaped sliding slot 2122a1, and the central fastening head 2122a6 is rotatably mounted within the central fastening slot 2122a3. The central fastening head 2122a6 and the central fastening slot 2122a3 engage with each other when pressure is applied to prevent the fixed shaft pivot from opening.

[0092] This specification also provides a delivery system comprising the external catheter 1000 or delivery component as defined above. The structural details, functional principles, and technical effects of the external catheter 1000 and delivery component have been described in detail above and will not be repeated here. For further details of the external catheter 1000 and delivery component, please refer to the description above.

[0093] The various technical features of the embodiments described above may be combined in any way. For the sake of brevity, not all such combinations are described above, but any of them are considered to fall within the scope of this specification, provided that there is no conflict between the technical features.

[0094] Several embodiments of this application are presented above. While these embodiments are described with some specificity and in some detail, they should not be construed as limiting the scope of this application in any sense. It should be noted that various modifications and alterations can be made by those skilled in the art without departing from the concepts of this application. Accordingly, all such modifications and alterations are intended to be included within the scope of this application as defined in the appended claims. [Explanation of Symbols]

[0095] 1000 External catheter 2000 Internal Catheter 3000 pull wire 4000 Stent Holder 5000 Inner core tube 1100 Main catheter body 1200 External catheter flexible section 1300 External catheter pushing section 1100a Outer catheter outer layer 1100b Outer catheter inner layer 1200a Pivot adjustment slot 1200b Pivotal locking element 1200c sealing element 1210 First axial bending resistance portion 1220 External catheter bending facilitator 1310 Second axial bending resistance portion 1221 The first cavity 1222 Second arc-shaped slot 1223 Arc-shaped cutting groove 1221a First arc-shaped slot 1221b First circular slot 1222a Axial straight hole 4100 Inner hole 4200 Wire fastener 4300 Stent Retaining Member 4400 Distal guide member 2100 Internal catheter flexible section 2200 Internal catheter pushing section 2100a Inner catheter outer layer 2100b Inner catheter inner layer 2100c reinforcement layer 2100d Guide Lumen 2110 Inner catheter axial bending resistance portion 2120 Internal catheter bending facilitator 2130 Pull Channel 2121 Second cavity 2122 Joining Unit 2121a Third arc-shaped slot 2121b Second circular slot 2122a Fixed axis pivot 2122b Rotation gap 2122a1 First arc-shaped sliding slot 2122a2 First arc-shaped fastening arm 2122a3 Central fastening slot 2122a4 Second arc-shaped sliding slot 2122a5 Second arc-shaped fastening arm 2122a6 Central fastening head

Claims

1. An external catheter for use in a delivery system, An outer catheter comprising a main catheter body having an axial lumen, wherein the main catheter body comprises an outer catheter bendable section and an outer catheter push section along the axial direction, the outer catheter bendable section comprises a first axial bending resistance portion extending along the axial direction, the first axial bending resistance portion configured to resist bending of the outer catheter bendable section along the axial plane on which the first axial bending resistance portion is located, the outer catheter push section comprises a second axial bending resistance portion extending along the axial direction, the second axial bending resistance portion configured to resist bending of the outer catheter push section along the axial plane on which the second axial bending resistance portion is located, and an angle is formed between the axial plane on which the first axial bending resistance portion is located and the axial plane on which the second axial bending resistance portion is located.

2. The outer catheter bendable section and the outer catheter pressing section are integrally formed structures, and the proximal end of the outer catheter bendable section is fixedly joined to the distal end of the outer catheter pressing section, or The outer catheter according to claim 1, wherein the outer catheter bendable section and the outer catheter push section are separate structures, the proximal end of the outer catheter bendable section is rotatably coupled to the distal end of the outer catheter push section, and the plane angle between the axial planes on which the first and second axial bending resistance portions are located is adjustable based on fixed axis rotation between the outer catheter bendable section and the outer catheter push section.

3. The outer catheter according to claim 2, wherein a pivot adjustment slot and a mating pivot locking element are provided at the proximal end of the outer catheter bendable section and the distal end of the outer catheter push section, respectively, the pivot adjustment slot extends in the circumferential direction, and the pivot locking element slides along the pivot adjustment slot to adjust the angle of fixed axis rotation between the outer catheter bendable section and the outer catheter push section.

4. The outer catheter bendable section has two first axial bending resistance portions that are symmetrical with respect to the central axis of the outer catheter bendable section, and / or The outer catheter according to claim 1, wherein the outer catheter pressing section has two second axial bending resistance portions that are symmetrical with respect to the central axis of the outer catheter pressing section.

5. The outer catheter according to claim 1, wherein the surface of the outer catheter bendable section comprises an outer catheter bending facilitating portion extending along the axial direction, the outer catheter bending facilitating portion does not overlap with the axial plane on which the first axial bending resistance portion is located, and the outer catheter bending facilitating portion is configured to at least enable the outer catheter bendable section to bend in a direction perpendicular to the axial plane on which the first axial bending resistance portion is located.

6. The outer catheter according to claim 5, wherein the outer catheter bendable section comprises two outer catheter bending-facilitating portions that are symmetrical with respect to the central axis of the outer catheter bendable section.

7. The outer catheter according to claim 6, wherein a plurality of first cavities are provided in the outer catheter bending facilitating portion, the first cavity comprises a first arc-shaped slot and two first circular slots located at both ends of the first arc-shaped slot, the first arc-shaped slot extends circumferentially and is perpendicular to the central axis of the outer catheter bending portion, the plurality of first cavities are arranged along the axial direction of the outer catheter bending portion, and the region between the two outer catheter bending facilitating portions constitutes the first axial bending resistance portion.

8. The outer catheter bending facilitating portion is provided with a plurality of second arc-shaped slots extending circumferentially and perpendicular to the central axis of the outer catheter bending section, and the plurality of second arc-shaped slots are arranged along the axial direction of the outer catheter bending section, and / or The first axial bending resistance portion is provided with at least two lines of axial straight holes extending along the axial direction, and a bending resistance spine portion for resisting bending of the outer catheter bendable section is provided between the two lines of axial straight holes. The external catheter according to claim 6.

9. The external catheter according to claim 8, wherein each axially linear hole comprises a plurality of hole units spaced apart in the axial direction.

10. The outer catheter according to claim 6, wherein the outer catheter bending-facilitating portion is provided with a plurality of arc-shaped cutting grooves extending in the circumferential direction and perpendicular to the central axis of the outer catheter bending section, the plurality of arc-shaped cutting grooves are arranged along the axial direction of the outer catheter bending section, and the plurality of arc-shaped cutting grooves of the two outer catheter bending-facilitating portions are partially alternate along the axial direction.

11. The proximal end of the outer catheter bendable section is provided with a diameter-changing section connected to the distal end of the outer catheter pressing section, and the diameter of the diameter-changing section of the outer catheter pressing section gradually decreases from the distal end to the proximal end, and / or The flexible section of the outer catheter comprises an outer layer and an inner layer. The external catheter according to claim 1.

12. An external catheter according to any one of claims 1 to 11, An inner catheter having a guide lumen, the inner catheter being movably attached within the axial lumen of the outer catheter, A pull wire connected to at least one of the outer catheter and the inner catheter, A stent body with a valve attached, wherein the stent body and the valve are configured to be installed between the inner catheter and the outer catheter. A delivery component equipped with the following features.

13. A stent holder provided at the distal end of the internal catheter, and / or An inner core tube having a core tube lumen, wherein the proximal end of the inner core tube communicates with the distal end of the inner catheter, and at least one of the guide lumen and the core tube lumen is configured for a guide wire to pass through therein. The delivery component according to claim 12, comprising:

14. The stent holder has an inner hole that communicates with the guide lumen, and / or The stent holder comprises a wire fastener, and / or The stent holder comprises a stent holding member, and / or A distal guide member is provided at the distal end of the inner core tube. The delivery component according to claim 13.

15. The delivery component according to claim 12, wherein at least one axial section of the inner catheter comprises an inner catheter axial bending resistance portion extending along the axial direction, and the inner catheter axial bending resistance portion is configured to resist bending of the inner catheter along the axial plane in which the inner catheter axial bending resistance portion is located.

16. The delivery component according to claim 15, wherein the inner catheter comprises two inner catheter axial bending resistance portions that are symmetrical with respect to the central axis of the inner catheter.

17. The delivery component according to claim 15, wherein the inner catheter comprises an inner catheter bendable section and an inner catheter push section along the axial direction, the proximal end of the inner catheter bendable section is coupled to the distal end of the inner catheter push section, and the inner catheter axial bending resistance portion is provided at least within the inner catheter bendable section.

18. The distal end of the pull wire is connected to the distal end of the flexible section of the inner catheter, or The pull wire is passed through the guide lumen of the inner catheter, or At least a portion of the inner catheter is provided with a pull channel, and the pull wire is passed through the pull channel of the inner catheter. The delivery component according to claim 17.

19. The delivery component according to claim 17, wherein the flexible portion of the inner catheter comprises an outer layer of the inner catheter, an inner layer of the inner catheter, and a reinforcing layer between the outer layer of the inner catheter and the inner layer of the inner catheter.

20. The delivery component according to claim 19, wherein a tension channel is provided between the outer layer of the inner catheter and the reinforcing layer, or a tension channel is provided in the inner wall of the inner layer of the inner catheter.

21. The delivery component according to claim 17, wherein the surface of the inner catheter bendable section comprises an inner catheter bending facilitating portion extending along the axial direction, the inner catheter bending facilitating portion does not overlap with the axial plane on which the inner catheter axial bending resistance portion is located, and the inner catheter bending facilitating portion is configured to at least enable the inner catheter bendable section to bend in a direction perpendicular to the axial plane on which the inner catheter axial bending resistance portion is located.

22. The delivery component according to claim 21, wherein the inner catheter bendable section is provided with two inner catheter bending-facilitating portions that are symmetrical with respect to the central axis of the inner catheter bendable section.

23. The delivery component according to claim 22, wherein the internal catheter bending facilitating portion comprises a plurality of second cavities including a third arc-shaped slot and two second circular slots located at both ends of the third arc-shaped slot, the third arc-shaped slot extending circumferentially and perpendicular to the central axis of the internal catheter bending portion, the plurality of second cavities arranged along the axial direction of the internal catheter bending portion, and the region between the two internal catheter bending facilitating portions constitutes the internal catheter axial bending resistance portion.

24. The delivery component according to claim 22, wherein the internal catheter bendable section comprises a plurality of joint units articulated and rotatably connected along the axial direction, a fixed axis pivot is provided between adjacent joint units, the fixed axis pivot is located in the portion of the internal catheter that resists axial bending, a rotation gap is provided between adjacent joint units, and the rotation gap is provided in the portion of the internal catheter that facilitates bending.

25. The fixed shaft pivot portion comprises a shaft portion and a hole provided in an adjacent joint unit, or The delivery component according to claim 24, wherein the fixed shaft pivot comprises a first rotatable engagement structure and a second rotatable engagement structure provided on an adjacent joining unit, the first rotatable engagement structure comprises a first arc-shaped sliding slot, a first arc-shaped fastening arm, and a central fastening slot, the second rotatable engagement structure comprises a second arc-shaped sliding slot, a second arc-shaped fastening arm, and a central fastening head, the first arc-shaped fastening arm is slidably mounted along the second arc-shaped sliding slot, the second arc-shaped fastening arm is slidably mounted along the first arc-shaped sliding slot, and the central fastening head is rotatably mounted within the central fastening slot.

26. An external catheter according to any one of claims 1 to 11, or Delivery component according to any one of claims 12 to 25 A delivery system equipped with the following features.

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