Catheter assembly and transport system

Abstract

Catheter assembly and delivery system. The catheter assembly includes an inner catheter (1000), an inner core tube (2000), and a sealing member (3000). The inner catheter (1000) has an axially extending catheter lumen, and the inner core tube (2000) has an axially extending core lumen and is positioned within the catheter lumen of the inner catheter (1000), with a gap between the outer wall of the inner core tube (2000) and the inner wall of the inner catheter (1000). The sealing member (3000) is provided on at least one of the inner catheter (1000) and the inner core tube (2000) and seals the gap between them. The sealing member (3000) plays a role in sealing the gap between the outer wall of the inner core tube (2000) and the inner wall of the inner catheter (1000) before and throughout the procedure, thereby preventing the sealed gap from communicating the in vivo environment with the outside world and fundamentally resolving the problem of blood leakage. Because the gap is sealed by the sealing member (3000), the difficult air removal procedure that surgeons have to perform before the procedure begins is no longer necessary, making the entire procedure easier and faster.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly, to catheter assemblies and delivery systems.

Background Art

[0002] Heart valve replacement involves using a delivery system to deliver, for example, a mitral valve, a tricuspid valve, a pulmonary valve or a similar valve to a target site such as the base of the aorta, and then releasing the valve at that site after accurate positioning is confirmed to replace the natural valve. This has become a very sought-after state-of-the-art technology in the field of valvular heart disease and a milestone in minimally invasive intervention therapy for aortic valve disease. This technique can be used to treat aortic valve disease without the need for thoracotomy, cardiac arrest or other highly invasive interventions that may be required in conventional surgical procedures. However, heart valve replacement procedures using a delivery system may cause blood leakage during valve delivery by the delivery system, which may interfere with the implementation of the procedure and tend to threaten the health of the patient.

Summary of the Invention

Problems to be Solved by the Invention

[0003] In view of the above, it is necessary to provide a catheter assembly and a delivery system that overcome the above problems.

Means for Solving the Problems

[0004] Therefore, this specification provides an outer sheath having a sheath lumen extending axially, an inner catheter having a catheter lumen extending axially, the inner catheter being disposed within the sheath lumen of the outer sheath, An inner core tube having a core lumen extending in the axial direction, wherein the inner core tube is positioned within the catheter lumen of an inner catheter, and a gap exists between the outer wall of the inner core tube and the inner wall of the inner catheter, A sealing member provided in at least one of the inner catheter and the inner core tube, which seals the gap between the inner core tube and the inner catheter, A control member configured to connect to an inner catheter and control the bending of the inner catheter, wherein the outer sheath bends together with the inner catheter, and the control member... A catheter assembly is provided that includes the following:

[0005] In one embodiment, the inner core tube is movably positioned within the catheter lumen of the inner catheter.

[0006] Alternatively, the inner core tube can be fixed and positioned within the catheter lumen of the inner catheter.

[0007] In one embodiment, the distal end of the inner core tube protrudes from the distal end of the inner catheter, and the sealing member has a first through bore that is open at both ends, and the sealing member is positioned in a sealing manner on the inner core tube via the first through bore, and the sealing member is sealed to the distal end of the inner catheter.

[0008] In one embodiment, the sealing member comprises a first sealing body that makes sealing contact with the outer wall of the inner core tube, and the inner core tube is movably positioned within the catheter lumen of the inner catheter.

[0009] Alternatively, the sealing member may have a second sealing body that is sealed to the outer wall of the inner core tube, thereby allowing the inner core tube to be fixedly positioned within the catheter lumen of the inner catheter.

[0010] In one embodiment, the first seal body is an annular seal collar positioned within a first through bore, the annular seal collar extending circumferentially around the inner core tube and making sealing contact with the outer wall of the inner core tube.

[0011] Alternatively, the second seal body can be a sealing adhesive that adheres to the distal end of the sealing member, and the distal end of the sealing member is sealed and fixed to the outer wall of the inner core tube.

[0012] In one embodiment, the catheter assembly is The device includes a fixing member having a second through-bore open at both ends, the fixing member being positioned on top of the inner core tube via the second through-bore, the fixing member being sealed to the distal end of the inner catheter, the sealing member being indirectly sealed to the distal end of the inner catheter via the fixing member, a third sealing body being positioned between the sealing member and the fixing member, the fixing member being in sealing contact with the outer wall of the inner core tube, and the inner core tube being movably positioned within the catheter lumen of the inner catheter.

[0013] In one embodiment, an engaging head portion and an engaging recess are provided at the proximal end of the sealing member and the distal end of the fixing member, respectively, the proximal end of the sealing member is sealed and coupled to the distal end of the fixing member via the engaging head portion and the engaging recess, the third seal body is an annular seal, the annular seal extends circumferentially around the inner core tube, seals in contact with the outer wall of the inner core tube, and is located between the end of the engaging head portion and the bottom of the engaging recess.

[0014] In one embodiment, a control member is positioned at the proximal end of the inner catheter and coupled to the proximal end of the inner core tube, and the control member is connected to the inner catheter via a control wire to control the bending of the inner catheter.

[0015] In one embodiment, the catheter assembly is It features a distal guide head positioned at the distal end of the inner core tube.

[0016] Furthermore, this specification provides a delivery system comprising the catheter assembly defined above.

[0017] In the catheter assembly and delivery system described above, the sealing member can be provided on the inner catheter or on the inner core tube. The sealing member plays a role in sealing the gap between the outer wall of the inner core tube and the inner wall of the inner catheter before and throughout the procedure, thereby preventing the sealed gap from communicating the in vivo environment with the outside world and fundamentally resolving the problem of blood leakage. Because the gap is sealed by the sealing member, the difficult air removal procedure required by the surgeon before the procedure begins is no longer necessary, making the entire procedure easier and faster. [Brief explanation of the drawing]

[0018] [Figure 1] This figure schematically shows a catheter assembly according to an embodiment of the present application. [Figure 2] This figure schematically shows a catheter assembly according to another embodiment of the present application. [Figure 3] This figure schematically shows a sealing member employing the first sealing approach according to an embodiment of this application. [Figure 4] This figure schematically shows a sealing member employing a second sealing approach according to an embodiment of the present application. [Figure 5] This is a schematic enlarged view of the sealing member in Figure 4, which employs the first sealing approach. [Figure 6] This figure schematically shows a sealing member employing a third sealing approach according to an embodiment of the present application. [Figure 7] This diagram schematically shows a catheter assembly according to an embodiment of the present application, in which the outer sheath is overshooting. [Figure 8] This figure schematically shows a catheter assembly according to an embodiment of the present application, in which the outer sheath is prevented from overshooting.

Best Mode for Carrying Out the Invention

[0019] The objectives, advantages, and features of this application will become clearer by reading the following more detailed description of specific embodiments in conjunction with the accompanying drawings. In the following description, numerous details are set forth in order to provide a complete understanding of this application. However, this application can be implemented in many other forms than those described herein, and those skilled in the art can make similar improvements without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0020] It is understood that terms such as "center," "longitudinal direction," "lateral direction," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial direction," "radial direction," "circumferential direction," etc. may be used in this specification to describe directional or positional relationships based on the orientation shown in the figures. These are merely intended to facilitate and simplify the description of this application and do not suggest or imply that the described components or elements must include or be configured or operated in a specific orientation. Therefore, these should not be construed as limiting this application.

[0021] Furthermore, when used in this specification, terms such as "first," "second," etc. are only intended for description and should not be construed as indicating or implying relative importance or implicitly indicating the number of items being referred to. Therefore, defining an item as "first" or "second" does not explicitly or implicitly indicate the existence of one or at least two such items unless otherwise indicated by the context. As used in this specification, the term "plural" means "at least two," for example two or three, unless otherwise clearly defined.

[0022] When used herein, unless otherwise clearly specified or defined, the terms “attached,” “joined,” “connected,” “fixed,” and variations thereof should be interpreted in a broad sense. For example, a connection may be a permanent connection, a removable connection or an integral connection, or a mechanical or electrical connection, or a direct or indirect connection involving one or more intervening media, or internal communication or interaction between two elements. Those skilled in the art will understand the specific meaning of the above terms herein, depending on the context.

[0023] 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 one or more intervening media. If a first feature is described as being "above," "above," or "on top" of a second feature, it may be directly above, diagonally above, above, or on top of the second feature, or simply at a higher level than the second feature. If a first feature is described as being "below," "below," or "at the bottom" of a second feature, it may be directly below, diagonally below, below, or at the bottom of the second feature, or simply at a lower level than the second feature.

[0024] When a component is said to be “fixed” or “positioned” to another component, it should be noted that it may be directly on the other component or there may be an intervening component. When a component is said to be “connected” or “joined” to another component, it may be directly connected or joined to the other component or there may be an intervening component. As used herein, terms such as “vertical,” “horizontal,” “up,” “down,” “left,” and “right” are merely illustrative and do not represent the only possible embodiments.

[0025] To more clearly describe the structure of the catheter assemblies and delivery systems proposed herein, the term “distal end” as used herein refers to the end further away 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 which this application pertains. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit this application.

[0026] Referring to Figure 1, in one embodiment described herein, a catheter assembly is provided comprising an inner catheter 1000, an inner core tube 2000, and a sealing member 3000. The inner catheter 1000 comprises an axially extending catheter lumen, and the inner core tube 2000 comprises an axially extending core lumen. The inner core tube 2000 is positioned within the catheter lumen of the inner catheter 1000, leaving a gap between the outer wall of the inner core tube 2000 and the inner wall of the inner catheter 1000. The sealing member 3000 is provided on at least one of the inner catheter 1000 and the inner core tube 2000, and seals the gap between the inner core tube 2000 and the inner catheter 1000.

[0027] A catheter assembly forms part of a delivery system used in cardiac valve replacement, such as transcatheter aortic valve replacement. Referring to Figure 2, the catheter assembly may further include an outer sheath 7000, a distal guide head 8000, and a control member 5000. In one embodiment, the outer sheath 7000 has an axially extending see-through membrane, and the inner catheter 1000 is movably positioned within the see-through membrane of the outer sheath 7000. The distal guide head 8000 is positioned at the distal end of the inner core tube 2000 and may have a tapered or similar shape to facilitate the advancement of the entire catheter assembly. The control member 5000 is positioned at the proximal end of the inner catheter 1000 and can be fixed therein by various approaches, including, but not limited to, screw connections, snap engagements, and adhesive bonds. The control member 5000 is used to steer the inner catheter 1000 by various approaches. For example, the control member 5000 is connected to a corresponding position on the inner catheter 1000 via a control wire 6000, and the connection can be formed at a location on the inner catheter 1000 that is central or peripheral to the distal end. The control member 5000 can be operated to tighten or loosen the control wire 6000 to bend the inner catheter 1000 in a desired manner. Those skilled in the art can select a suitable configuration as desired without departing from the scope of this application.

[0028] The presence of a gap between the outer wall of the inner core tube 2000 and the inner wall of the inner catheter 1000 in a catheter assembly necessitates that the surgeon remove air from the gap, for example, by filling it with a liquid such as saline or heparin solution, before the delivery system is used for valve delivery. This is because air present in the gap tends to communicate the in vivo environment (e.g., vascular lumen) with the outside world, thus causing blood leakage, which not only hinders the performance of the procedure but also tends to threaten the patient's health. Furthermore, the presence of the gap tends to trap air, which, if it enters the in vivo environment (e.g., vascular lumen), may cause certain damage to the patient.

[0029] However, limited by the small overall diameter of the delivery system, the inner catheter 1000 and inner core tube 2000 in the catheter assembly, particularly the inner core tube 2000, must be manufactured to very small sizes. As a result, the gap between the outer wall of the inner core tube 2000 and the inner wall of the inner catheter 1000 is actually very small, making it very difficult to remove air from the gap. To overcome this, the proposed catheter assembly additionally includes a sealing member 3000, which can be provided on the inner catheter 1000 or on the inner core tube 2000, to seal the gap between the outer wall of the inner core tube 2000 and the inner wall of the inner catheter 1000 before and throughout the procedure. The sealed gap prevents the in vivo environment from communicating with the outside world, thereby fundamentally solving the problem of blood leakage. With the gap sealed by the sealing member 3000, the difficult air removal operation for the surgeon before the procedure begins is no longer required, making the entire procedure easier and faster.

[0030] The distal end of the inner core tube 2000 extends from the distal end of the inner catheter 1000, and this portion is referred to as the loading section used for loading a valve stent, thereby positioning the valve stent between the inner core tube 2000 and the outer sheath 7000. After being delivered to the target site by the catheter assembly, the valve stent can be released simply by pulling back the outer sheath 7000, after which it switches from a crimped configuration to an expanded configuration at the target site. Due to the small diameter of the inner core tube 2000, if a sealing member 3000 is provided on the inner core tube 2000, the valve stent can be crimped onto the sealing member 3000 and thus indirectly loaded onto the inner core tube 2000. This facilitates the loading of the valve stent on the one hand and provides support and protection to the inner core tube 2000 on the other hand. This is because the valve stent is directly supported on the sealing member 3000 rather than on the inner core tube 2000, and the sealing member 3000 is interposed between the valve stent and the inner core tube 2000, thus preventing the inner core tube 2000 from undesiring bending during, for example, delivery, loading, passage through the aortic arch, discharge, or retrieval of the valve stent.

[0031] In particular, the guidewire can be inserted into the core lumen of the inner core tube 2000 and used to guide the catheter assembly forward during delivery. Specifically, the guidewire can be in contact with the wall of the blood vessel, and the catheter assembly can follow the path of the guidewire. Furthermore, during catheter maneuvering, the guidewire passively bends in response to bending of the inner catheter 1000 and the inner core tube 2000, preventing undesirable bending of the inner core tube 2000. Thus, the core lumen of the inner core tube 2000 remains open at all times, advantageously ensuring the smooth advancement and passage of the guidewire through it. Otherwise, bending of the inner core tube 2000 may lead to occlusion and closure of the core lumen, preventing the guidewire from passing through it. Preventing bending of the inner core tube 2000 also facilitates the robust discharge of the valve stent.

[0032] The gap between the inner core tube 2000 and the inner catheter 1000 is sealed by the sealing member 3000, so that, referring to Figures 3 to 6, the inner core tube 2000 can be movably positioned within the catheter lumen of the inner catheter 1000. Here, "movably positioned within the catheter lumen of the inner catheter 1000" means that the inner core tube 2000 is at least axially movable relative to the catheter lumen of the inner catheter 1000. In this case, the inner core tube 2000 can be coupled to the control member 5000 at its proximal end. Therefore, the mobility of the inner core tube 2000 relative to the inner catheter 1000 means that the proximal end of the inner core tube remains stationary, while the distal end and adjacent portions of the inner core tube are movable relative to the inner catheter 1000. Alternatively, the inner core tube 2000 can be positioned in a manner fixed within the catheter lumen of the inner catheter 1000; that is, the inner core tube 2000 can be fixedly positioned within the catheter lumen of the inner catheter 1000. In this case, the inner core tube 2000 may not be axially movable, at least relative to the catheter lumen of the inner catheter 1000.

[0033] The inner catheter 1000 is typically made from a polymer material, which imparts a certain degree of axial contraction to the inner catheter 1000. Specifically, in a catheter assembly where the inner catheter 1000 is actively steered, the application of steering tensile force causes the inner catheter 1000 to experience a certain degree of axial contraction. On the other hand, the bending of the outer sheath 7000 is primarily a passive response and is induced by compressive stress from the bent distal end of the inner catheter 1000. In contrast, the outer sheath 7000 itself does not undergo actual axial contraction. Referring to Figure 7, in some cases, active steering of the catheter assembly may be necessary for the catheter assembly to pass smoothly through the aortic arch. Such active steering of the inner catheter 1000 can be achieved by operating the control member 5000 to pull the control wire 6000, and thus pulling a portion of the inner catheter 1000, which is located, for example, at the distal end or periphery of the inner catheter 1000. More specifically, as a result of the control wire 6000 being pulled by the operation of the control member 5000, the inner catheter 1000 is bent distally and actively steered in the desired direction.

[0034] However, when the inner catheter 1000 is pulled and contracted axially, a relative displacement occurs between the inner catheter 1000 and the outer sheath 7000, particularly axially. As a result, the outer sheath 7000 moves distally axially relative to the inner catheter 1000 by a distance equal to the amount of axial contraction, ultimately leading to the distal end of the outer sheath 7000 "overshooting" the distal end of the inner catheter 1000, as shown in Figure 7, and interfering with the distal guide head 8000. This prevents the smooth retraction of the outer sheath 7000 along with the delivery system.

[0035] Continuing to refer to Figure 7, if the inner core tube 2000 is fixed within the catheter lumen of the inner catheter 1000, when the inner catheter 1000 is pulled by the control wire 6000, the inner core tube 2000 contracts together with the inner catheter 1000, leading to interference contact between the distal end of the outer sheath 7000 and the distal guide head 8000 located at the distal end of the inner core tube 2000 (resulting in "overshoot").

[0036] Referring to Figure 8, if the inner core tube 2000 is movably positioned within the catheter lumen of the inner catheter 1000, it becomes axially movable relative to the catheter lumen of the inner catheter 1000. Therefore, when the inner catheter 1000 is pulled by the control wire 6000, the inner core tube 2000 may not necessarily contract together with the inner catheter 1000. For example, in response to the axial contraction of the inner catheter 1000, the inner core tube 2000 may move axially relative to it but not axially contract together with it. Therefore, the inner core tube 2000 may remain axially stationary relative to the outer sheath 7000, thereby mitigating or eliminating the overshoot of the outer sheath 7000. In particular, if the distal end of the inner core tube 2000 is coupled to the control member 5000, the control member 5000 resists the axial contraction of the inner core tube 2000, maintaining it axially stable and unaffected by the axial contraction of the inner catheter 1000.

[0037] The sealing member 3000 can be manufactured from a polymer material having relatively low hardness, such as Pebax or silicone, by a single injection molding process. The sealing member 3000 can be any of a variety of suitable structures as desired. For example, the sealing member 3000 can be cylindrical, tapered, stepped, or other shapes without departing from the scope of this application.

[0038] In one embodiment, the sealing member 3000 may have a first through bore that is open at both ends, thereby allowing the sealing member 3000 to be positioned in a sealing manner on the inner core tube 2000. Alternatively, the sealing member 3000 can be sealed to the distal end of the inner catheter 1000. Referring to Figure 3, for example, the sealing member 3000 may have a first sealing body 3100, which seals in contact with the outer wall of the inner core tube 2000 while not restricting its axial movement. This ensures the mobility of the inner core tube 2000 within the catheter lumen of the inner catheter 1000. The first sealing body 3100 can be any of a variety of suitable structures. For example, the first sealing body 3100 can be implemented as an annular sealing collar provided within the first through bore. Specifically, the annular sealing collar may extend circumferentially around the inner core tube 2000 and seal in contact with its outer wall. Notably, the sealing contact of the annular seal collar with the outer wall of the inner core tube 2000 does not restrict the axial movement of the inner core tube 2000.

[0039] The annular seal collar is also made from a polymer material. The annular seal collar can seal the gap without restricting the axial movement of the inner core tube 2000, so that during active steering of the inner catheter 1000, the inner core tube 2000 does not contract axially in response to the axial contraction of the inner catheter 1000. Therefore, the inner core tube 2000 can remain axially stationary relative to the outer sheath 7000 and does not cause overshoot of the outer sheath 7000.

[0040] Referring to Figures 4 and 5, in one embodiment, the sealing member 3000 may have a second sealing body 3200 that is sealed to the outer wall of the inner core tube 2000, sealing the gap while restricting the axial movement of the inner core tube 2000 relative to the inner catheter 1000, thereby fixing the inner core tube 2000 within the catheter lumen of the inner catheter 1000. The second sealing body 3200 can be any of a variety of suitable structures. For example, the second sealing body 3200 may be a sealing adhesive, which is bonded to the distal end of the sealing member 3000 to provide both a sealing and fixing effect. The sealing adhesive can seal the distal end of the sealing member 3000 to the outer wall of the inner core tube 2000, thereby fixing the inner core tube 2000 to the inner catheter 1000.

[0041] In one embodiment, the catheter assembly may additionally include a fixing member 4000 that hooks the valve stent by engaging with the lug or similar structure of the valve stent. The fixing member 4000 may have a groove or similar structure for arranging a control wire 6000. The control wire 6000 is positioned in the groove or similar feature of the fixing member 4000 and connected to a proximal control member 5000, thereby being operated. The surgeon can operate the control wire 6000 through the control member 5000 to actively steer the inner catheter 1000. As shown in Figure 6, the fixing member 4000 may have a second through bore that is open at both ends, thereby allowing the fixing member 4000 to be positioned on the inner core tube 2000. At the same time, the fixing member 4000 can be sealed and fixed to the distal end of the inner catheter 1000. For example, the proximal end of the fixing member 4000 can be adhesively bonded to the distal end of the inner catheter 1000, thereby connecting the second through-bore of the fixing member 4000 to the catheter lumen of the inner catheter 1000. Thus, the sealing member 3000 is indirectly sealed to the distal end of the inner catheter 1000 via the fixing member 4000.

[0042] The third seal body 3300 can be positioned between the seal member 3000 and the fixing member 4000, and the third seal body 3300 makes sealing contact with the outer wall of the inner core tube 2000 while not restricting the axial movement of the inner core tube 2000. This ensures the mobility of the inner core tube 2000 within the catheter lumen of the inner catheter 1000. The third seal body 3300 can be any of a variety of suitable structures. For example, the seal member 3000 may have an engaging recess 3000a at its proximal end, and the fixing member 4000 may have an engaging head portion 4000a at its distal end. In this case, the proximal end of the seal member 3000 can be sealed and coupled to the distal end of the fixing member 4000 by engaging the engaging head portion 4000a with the engaging recess 3000a. The third seal body 3300 can be an annular seal, which extends circumferentially around the inner core tube 2000, making sealing contact with its outer wall, and is located between the end of the engaging head portion 4000a and the bottom of the engaging recess 3000a.

[0043] The engaging head portion 4000a can be a plug head portion or a threaded head portion, and the engaging recess 3000a can be a socket or a threaded recess. For example, the fixing member 4000 can be screw-connected to the sealing member 3000 by the threaded head portion and the threaded recess. The threaded recess may further comprise an annular sealing groove, and the annular seal can be implemented as a seal ring made from a polymer material such as medical-grade silicone or fluororubber. The seal ring can be positioned on the inner core tube 2000 before the inner core tube 2000 is inserted into the first through bore of the sealing member 3000. The threaded head portion of the fixing member 4000 can then be screwed into the threaded recess of the sealing member 3000, thus finally enclosing the seal ring within the annular sealing groove of the sealing member 3000. The continuous compression of the seal ring by the sealing member 3000 and the fixing member 4000 causes it to deform radially, thereby achieving sealing of the gap between the inner catheter 1000 and the inner core tube 2000, while allowing the inner core tube 2000 to move axially within the catheter lumen of the inner catheter 1000 to prevent overshoot of the outer sheath 7000.

[0044] Furthermore, this specification provides a delivery system incorporating a catheter assembly. The structural details, functional principles, and technical advantages of the catheter assembly have been described above and will not be repeated for brevity. For further details on this matter, please refer to the above description.

[0045] The various technical features of the embodiments described above can be combined in any way. For the sake of brevity, not all such combinations are described above, but any of them are considered to be within the scope of this specification, as long as there is no contradiction between the technical features.

[0046] The embodiments described above are merely some of the embodiments of this application. While these embodiments are described in some detail and have some specific characteristics, they should not be construed as limiting the scope of this application in any way. 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]

[0047] A section without overshoot B. Section with overshoot 1000 Internal Catheter 2000 Inner core tube 3000 sealing member 4000 Fixing member 5000 Control component 6000 control wires 7000 Outer sheath 8000 Distal Guide Head 3100 First seal body 3200 Second seal body 3300 Third Seal Body 3000a Engaging recess 4000a Engagement head portion

Claims

1. An outer sheath with a see-through membrane extending in the axial direction, An inner catheter having an axially extending catheter lumen, wherein the inner catheter is disposed within the sheath lumen of the outer sheath, An inner core tube having a core lumen extending in the axial direction, wherein the inner core tube is positioned within the catheter lumen of the inner catheter, and a gap exists between the outer wall of the inner core tube and the inner wall of the inner catheter, A sealing member provided in at least one of the inner catheter and the inner core tube, which seals the gap between the inner core tube and the inner catheter, A control member configured to connect to the inner catheter and control the bending of the inner catheter, wherein the outer sheath bends together with the inner catheter, and the control member A catheter assembly comprising the above features.

2. The inner core tube is movably positioned within the catheter lumen of the inner catheter, or The catheter assembly according to claim 1, wherein the inner core tube is fixedly positioned within the catheter lumen of the inner catheter.

3. The catheter assembly according to claim 1, wherein the distal end of the inner core tube protrudes from the distal end of the inner catheter, the sealing member comprises a first through bore with both ends open, the sealing member is positioned in a sealing manner on the inner core tube via the first through bore, and the sealing member is sealed to the distal end of the inner catheter.

4. The sealing member comprises a first sealing body that makes sealing contact with the outer wall of the inner core tube, and the inner core tube is movably arranged within the catheter lumen of the inner catheter, or The catheter assembly according to claim 3, wherein the sealing member has a second sealing body that is sealed and fixed to the outer wall of the inner core tube, thereby fixing and positioning the inner core tube within the catheter lumen of the inner catheter.

5. The first seal body is an annular seal collar disposed within the first through bore, the annular seal collar extending circumferentially around the inner core tube, and sealing contact with the outer wall of the inner core tube, or The catheter assembly according to claim 4, wherein the second seal body is a sealing adhesive that adheres to the distal end of the sealing member, and the distal end of the sealing member is sealed and fixed to the outer wall of the inner core tube via the sealing adhesive.

6. A catheter assembly according to claim 3, comprising a fixing member having a second through bore open at both ends, the fixing member being positioned on the inner core tube via the second through bore, the fixing member being sealed to the distal end of the inner catheter, the sealing member being indirectly sealed to the distal end of the inner catheter via the fixing member, a third sealing body being positioned between the sealing member and the fixing member, the fixing member being in sealing contact with the outer wall of the inner core tube, and the inner core tube being movably positioned within the catheter lumen of the inner catheter.

7. The catheter assembly according to claim 6, wherein an engaging head portion and an engaging recess are provided at the proximal end of the sealing member and the distal end of the fixing member, respectively, the proximal end of the sealing member is sealed to the distal end of the fixing member via the engaging head portion and the engaging recess, the third seal body is an annular seal, the annular seal extends circumferentially around the inner core tube, seals in contact with the outer wall of the inner core tube, and is located between the end of the engaging head portion and the bottom of the engaging recess.

8. The catheter assembly according to claim 1, wherein the control member is positioned at the proximal end of the inner catheter and coupled to the proximal end of the inner core tube, and the control member is connected to the inner catheter via a control wire to control the bending of the inner catheter.

9. The catheter assembly according to claim 1, further comprising a distal guide head positioned at the distal end of the inner core tube.

10. A delivery system comprising a catheter assembly according to any one of claims 1 to 9.

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