Stent assembly structure, catheter assembly, and delivery system

Abstract

This application relates to a stent loading structure. The fixing member comprises a fixing bore extending axially. The fixing bore is configured to insert an inner core tube. The fixing member has a distal fixing portion configured to fix the valve stent. The guide member comprises a guide bore extending axially, which is configured to insert an inner core tube. The proximal end of the guide member is coupled to the distal end of the fixing member so that the guide bore communicates with the fixing bore. The guide member, which is sleeved over the inner core tube, is configured to support the valve stent. By being guided by the guide member, the valve stent can be loaded more easily. Furthermore, since the valve stent is supported directly by the guide member rather than by the inner core tube which is thin and has a relatively small diameter, the guide member can fill the gap between the valve stent and the inner core tube. This can support the thin inner core tube and thereby protect it from bending that may occur during delivery or valve stent loading, ensuring the smooth passage of the guide wire and the robust discharge of the valve stent.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly, to a stent loading structure, a catheter assembly, and a delivery system.

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 aortic root, and then releasing the valve there after accurate positioning is confirmed to replace the native valve. This has become a state-of-the-art technology highly demanded in the field of valvular heart disease and a milestone in minimally invasive intervention treatment of aortic valve disease. This technology can be used to treat aortic valve disease without the need for thoracotomy, cardiopulmonary arrest or other highly invasive interventions that may be required in conventional surgical procedures.

[0003] Currently, the valve stents commonly used in heart valve replacement are self-expanding, and most systems for delivering self-expanding valve stents incorporate a multi-layer catheter composed of, for example, an inner core tube, an intermediate inner catheter, and an outer sheath. The inner core tube has a guide wire lumen, and the self-expanding valve stent is pre-loaded in a crimped configuration between the outer sheath and the inner core tube before surgery. Most of such valve stents have a flower shape when expanded, that is, the tines at the distal end of the valve stent are opened in a petal pattern, and these are mainly designed to provide support after expansion. However, two of their symmetric tines are intended to engage with the inner core tube to hook the self-expanding valve stent.

[0004] However, the inner core tube portion for loading self-expanding valve stents is typically very thin and has a small outer diameter, making it prone to undesirable bending during preoperative loading and intraoperative retrieval, affecting the passage of the guidewire through it and thus hindering the robust delivery of the self-expanding valve stent. Furthermore, the tines of the self-expanding valve stent are susceptible to stacking and twisting, which can easily cause scratches or other damage to the outer sheath of the delivery system. All of these are detrimental to the success of the procedure. [Overview of the project] [Problems that the invention aims to solve]

[0005] In view of the above, it is necessary to provide a stent loading structure, catheter assembly, and delivery system that overcome at least one of the aforementioned problems. [Means for solving the problem]

[0006] Therefore, this specification includes, A fixing member having an axially extending fixing bore, wherein the fixing bore is configured to insert an inner core tube, and the fixing member has a distal fixing portion configured to fix a valve stent, A guide member comprising an axially extending guide bore, wherein the guide bore is configured to insert an inner core tube, the proximal end of the guide member is coupled to the distal end of a fixed member such that the guide bore communicates with a fixed bore, and the guide member above the inner core tube is configured to support a valve stent. A separation member provided on the guide member and configured to support multiple branch portions of the valve stent by spacing them apart, A stent loading structure is provided that includes the following:

[0007] For one reason, the stent loading structure is, A sealing element, wherein the sealing element is positioned on a guide member and configured to seal the gap between the guide bore of the guide member and the outer wall of the inner core tube, or The device comprises a projection, the sealing element of which is positioned on the inner wall of the guide bore and configured to make sealing contact with the outer wall of the inner core tube.

[0008] In one embodiment, the guide member comprises a distal guide section and a proximal guide section, each of which is a cylindrical tube, and the maximum outer diameter of the distal guide section is smaller than the minimum outer diameter of the proximal section.

[0009] In addition or alternatively, the fixing member comprises a distal fixing section and a proximal fixing section, each of which is a cylindrical tube, wherein the maximum outer diameter of the distal fixing section is smaller than the minimum outer diameter of the proximal fixing section.

[0010] In one embodiment, the separating member is provided in the proximal guide section.

[0011] In addition or alternatively, a transition guide section is connected between the distal and proximal guide sections, the transition guide section being a cylindrical tube, and the outer diameter of the transition guide section gradually increases from the distal end to the proximal end.

[0012] In one embodiment, the separation member comprises a plurality of unit separators arranged circumferentially around the outer wall of the proximal guide section, with unit separation spaces provided between adjacent unit separators to accommodate the branch portions of the valve stent.

[0013] In one embodiment, the unit separator is a separation plate, and the height of the unit separator relative to the outer wall of the proximal guide section increases from the distal end to the proximal end.

[0014] In one embodiment, a first connecting member and a second connecting member are provided at the proximal end of the guide member and the distal end of the fixing member, respectively, and the proximal end of the guide member is connected to the distal end of the fixing member by the first connecting member and the second connecting member.

[0015] Alternatively, the proximal end of the guide member is adhesively fixed to the distal end of the fixing member.

[0016] In one embodiment, the first connecting member is a socket provided at the proximal end of the guide member, and the second connecting member is a plug provided at the distal end of the fixing member, the plug being inserted into the socket.

[0017] Alternatively, the first connecting member is a threaded bore provided at the proximal end of the guide member, and the second connecting member is a threaded stem provided at the distal end of the fixing member, with the threaded stem being screw-connected to the threaded bore.

[0018] Furthermore, this specification includes, An inner core tube having an axially extending guidewire lumen, wherein the guidewire lumen is configured to allow a guidewire to pass through, An inner catheter having an axially extending catheter lumen, wherein the inner core tube is positioned within the catheter lumen, and the distal end of the inner core tube extends from the distal end of the inner catheter, A stent loading structure in which a section of an inner core tube extending from an inner catheter is inserted into a fixing bore of a fixing member and a guide bore of a guide member, An outer sheath having an axially extending see-through membrane, wherein the inner core tube, inner catheter, and stent loading structure are each disposed within the outer sheath, A catheter assembly is provided that includes the following:

[0019] Furthermore, this specification includes, A delivery system is provided that includes a stent loading structure or a catheter assembly.

[0020] In the stent loading structure, catheter assembly, and delivery system, the guide member can be disposed in a sleeve-like manner over an inner core tube that is thin and may have a smaller diameter. By being guided by the guide member, the valve stent can be more easily loaded onto the inner core tube. Further, since the valve stent is directly supported by the guide member rather than by the thin inner core tube, the guide member can fill the gap between the valve stent and the inner core tube. This supports the thin inner core tube and thereby protects it from bending that may occur during delivery or loading of the valve stent, ensuring smooth passage of the guide wire and secure release of the valve stent.

Brief Description of the Drawings

[0021] [Figure 1] FIG. schematically shows a stent loading structure in a loading configuration according to one embodiment of the present application. [Figure 2] FIG. schematically shows a stent loading structure in a loading configuration according to another embodiment of the present application. [Figure 3] FIG. schematically shows a stent loading structure in a loading configuration according to yet another embodiment of the present application. [Figure 4] FIG. schematically shows a guide member according to one embodiment of the present application. [Figure 5] FIG. schematically shows a guide member according to another embodiment of the present application. [Figure 6] [[ID=​​​​​​​The purpose, 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. Numerous details are provided in the following description to provide a complete understanding of this application. However, this application can be implemented in many other forms not 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.

[0023] Terms such as "center," "longitudinal," "lateral," "length," "width," "thickness," "top," "bottom," "front," "back," "left," "right," "vertical," "horizontal," "top," "bottom," "inside," "outside," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" may be used in this specification to describe directional or positional relationships based on the orientation shown in the figures. These are intended solely to facilitate and simplify the description of this application and do not imply or suggest that the described components or elements include a particular orientation or must be configured or operated in a particular orientation. Therefore, they should not be construed as limiting this application.

[0024] Furthermore, as used herein, terms such as “first,” “second,” etc., are intended solely for descriptive purposes and should not be interpreted as indicating or implying relative importance, or implicitly indicating the number of items being referenced. Therefore, defining an item as “first” or “second” explicitly or implicitly indicates the existence of at least one such item. As used herein, the term “plural” means “at least two,” for example, two or three, unless otherwise explicitly defined.

[0025] 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 with an intervening medium, or internal communication or interaction between two elements. Those skilled in the art will be able to understand the specific meaning of the above terms herein, depending on the context.

[0026] 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 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.

[0027] 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” to another component, it may be directly connected 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.

[0028] Referring to Figure 1, one embodiment disclosed herein provides a stent loading structure comprising a fixing member 1000 and a guide member 2000. The fixing member 1000 extends axially and comprises a fixing bore configured for the insertion of an inner core tube 3000. The fixing member 1000 has a distal fixing portion 1100 configured for fixing a valve stent 5000. The guide member 2000 extends axially and comprises a guide bore configured for the insertion of an inner core tube 3000. The proximal end of the guide member 2000 is coupled to the distal end of the fixing member 1000 so that the guide bore communicates with the fixing bore. The guide member 2000 above the inner core tube 3000 is configured to support the valve stent 5000.

[0029] The fixing member 1000 can be any of a variety of suitable structures. For example, as shown in Figure 1, the fixing member 1000 can be a stepped structure. For example, the fixing member 1000 may include a distal fixing section 1000a and a proximal fixing section 1000b, both of which are cylindrical tubes. The maximum outer diameter of the distal fixing section 1000a is smaller than the minimum outer diameter of the proximal section. Alternatively, the distal fixing section 1000a and the proximal fixing section 1000b can be other structures, depending on what is required for fixing the valve stent 5000. Each of them can have any suitable regular or irregular external shape, such as prismatic or hemispherical, as long as the distal fixing section 1000a and the proximal fixing section 1000b of the fixing member 1000 constitute a stepped structure. Those skilled in the art can select any suitable structure without departing from the scope of this application.

[0030] The distal fixing portion 1100 of the fixing member 1000 may have any suitable structure, such as a notch or slot, that can secure the valve stent 5000, and these structures are shaped complementary to the lugs or other fitting structures of the valve stent 5000. By fitting such a structure, a robust loading of the valve stent 5000 is possible. Once the valve stent 5000 with a valve is fixed, the distal fixing portion 1100 can restrict its movement, for example, in the circumferential and axial directions. Those skilled in the art may, if necessary, achieve loading of the valve stent 5000 using similar or known approaches without departing from the scope of this application.

[0031] Continuing to refer to Figure 1, the guide member 2000 can be positioned in a sleeve-like manner on the inner core tube 3000. The inner core tube 3000 into which the valve stent 5000 is loaded can be thin and have a relatively small diameter. The guide member 2000 can guide and facilitate the loading of the valve stent 5000. Furthermore, with this arrangement, the valve stent 5000 is supported directly by the guide member 2000 rather than by the thin inner core tube 3000, and the guide member 2000 fills the gap between the valve stent 5000 and the inner core tube 3000. This supports the thin inner core tube 3000 and thereby protects it from bending that may occur during delivery or loading of the valve stent 5000.

[0032] The inner core tube 3000 is equipped with a guidewire lumen configured to allow a guidewire to pass through, and the guidewire lumen is used to guide the delivery system to advance along it during delivery. Specifically, the guidewire can be brought into contact with the wall of the blood vessel, and the delivery system advances along the path and direction guided by the guidewire. Furthermore, during catheter steering, the guidewire passively bends in response to bending of the inner core tube 3000. By preventing undesirable bending of the inner core tube 3000, it is ensured that its guidewire lumen remains open, which advantageously ensures the smooth advancement and passage of the guidewire. Otherwise, bending of the inner core tube 3000 may lead to local occlusion and closure of the guidewire lumen, which may no longer allow the guidewire to pass through it. Preventing bending of the inner core tube 3000 also facilitates the robust release of the valve stent.

[0033] Referring to Figures 1 to 3, in one embodiment, the stent loading structure may include a sealing element 2100, a projection 2200, or a similar component. Referring to Figure 1, the sealing element 2100 may be provided on the guide member 2000, for example, at its distal end. The sealing element 2100 can be made from any suitable material having sealing properties and is used to seal any gap that may remain between the guide bore of the guide member 2000 and the outer wall of the inner core tube 3000, for example, at the distal end of the guide member 2000, as shown in Figure 1. For example, the sealing element 2100 may be made from an adhesive material such as an adhesive. In this case, in addition to sealing any gap between the guide bore and the outer wall of the inner core tube 3000 at the distal end, the adhesive material may also attach the guide member 2000 to the inner core tube 3000, preventing undesirable relative rotation between them.

[0034] Continuing to refer to Figure 2, the stent loading structure may alternatively include a projection 2200. The projection 2200 may protrude from the inner wall of the guide bore and be configured to make sealing contact with the outer wall of the inner core tube 3000. Thus, the projection 2200 is, in effect, a circumferentially extending annular collar capable of completely sealing any circumferential gap between the inner wall of the guide bore and the outer wall of the inner core tube 3000. In this case, the projection 2200 may simply be in sealing contact with the outer wall of the inner core tube 3000 without completely preventing relative movement, for example, the axial relative movement between the guide member 2000 and the inner core tube 3000.

[0035] Continuing to refer to Figure 3, the sealing element 2100 can alternatively be positioned at the proximal end of the guide member 2000, for example, between the fixing member 1000 and the guide member 2000. In this case, the sealing element 2100 can be provided as a sealing ring or the like, made of rubber or another material having sealing properties, and used to seal the gap between the guide bore of the guide member 2000 and the outer wall of the inner core tube 3000. Those skilled in the art will know, without departing from the scope of this application, that such a gap between the guide bore of the guide member 2000 and the outer wall of the inner core tube 3000 can be sealed using different approaches, with or without selectively restricting their relative rotation.

[0036] The proximal end of the guide member 2000 can be coupled to the distal end of the fixing member 1000 by various approaches. For example, as shown in Figures 1 and 2, the proximal end of the guide member 2000 can be adhesively bonded to the distal end of the fixing member 1000. In an alternative embodiment, as shown in Figure 3, a first connecting member 1200 and a second connecting member 1300 are provided at the proximal end of the guide member 2000 and the distal end of the fixing member 1000, respectively. In this case, the proximal end of the guide member 2000 can be coupled to the distal end of the fixing member 1000 by the first connecting member 1200 and the second connecting member 1300. Specifically, the first connecting member 1200 can be a socket provided at the proximal end of the guide member 2000, and the second connecting member 1300 can be a plug provided at the distal end of the fixing member 1000. The plug can be fitted and coupled by being inserted into the socket. Alternatively, the first connecting member 1200 can be a threaded bore provided at the proximal end of the guide member 2000, and the second connecting member 1300 can be a threaded stem provided at the distal end of the fixing member 1000. The threaded stem can be screw-connected to the threaded bore.

[0037] The guide member 2000 can be formed by injection molding of a polymer material such as Pebax or silicone. The guide member 2000 can be any of a variety of suitable structures. For example, as shown in Figure 4, the guide member 2000 can be a stepped structure. For example, the guide member 2000 may include a distal guide section 2000a and a proximal guide section 2000b, both of which are cylindrical tubes. The maximum outer diameter of the distal guide section 2000a is smaller than the minimum outer diameter of the proximal section. Alternatively, the distal guide section 2000a and the proximal guide section 2000b can be other structures as required for supporting the valve stent 5000. Each of them can have any suitable regular or irregular external shape, such as prismatic or hemispherical, as long as the distal guide section 2000a and the proximal guide section 2000b of the guide member 2000 constitute a stepped structure. Those skilled in the art can select any suitable structure without departing from the scope of this application. Furthermore, referring to Figure 4, the transition guide section 2000c can be connected between the distal guide section 2000a and the proximal guide section 2000b. The transition guide section 2000c can be a cylindrical tube, and the outer diameter of the transition guide section gradually increases from the distal end to the proximal end.

[0038] Referring again to Figures 5 and 6, in one embodiment, in order to better support the valve stent 5000 without overlapping or twisting of its branch portions 5100, a separating member may be provided in the proximal guide section 2000b, and the valve stent 5000 may be switchable between an expanded configuration and a crimped configuration. Figure 6 shows the valve stent 5000 in a crimped configuration. The branch portions 5100 of the valve stent 5000 may be tines branching from one end of the valve stent 5000. The valve stent 5000 can be loaded in a crimped configuration on the fixing member 1000 and the guide member 2000 of the stent loading structure, with some of the branch portions 5100 fixed by the fixing member 1000 and the rest of the branch portions 5100 separated by the separating member. Therefore, the branch portions 5100 of the valve stent 5000 can be separated by the separating member while being supported thereon, preventing the branch portions 5100 from stacking and twisting.

[0039] The separation member can be any of a variety of suitable structures. For example, it can be a single, integrated member provided on the proximal guide section 2000b, or it can include a plurality of unit structures, all provided on the proximal guide section 2000b. Referring to Figure 5, the separation member can include a plurality of unit separators 2300 arranged circumferentially around the outer wall of the proximal guide section 2000b, so that a unit separation space 2300a is provided between adjacent unit separators 2300. The branch portions 5100 of the valve stent 5000 can be received in the unit separation space 2300a, thereby separating each from any other branch portions 5100. This provides guidance to the valve stent 5000 while preventing twisting, crossing, and stacking of the branch portions 5100 of the valve stent 5000, enabling more robust discharge and recovery of the valve stent 5000.

[0040] The unit separator 2300 can be any suitable structure, and the unit separation space 2300a can be any suitable shape, as long as the branch portion 5100 is held in a stable manner. Referring to Figure 5, in one embodiment, the unit separator 2300 can be formed in the shape of a plate with a height that increases from the distal end to the proximal end relative to the outer wall of the proximal guide section 2000b. The unit separator 2300 can also be any other structure as appropriate, for example, a mesh, a projection, etc. Those skilled in the art can make an appropriate selection according to the actual situation without departing from the scope of this application.

[0041] Furthermore, this specification provides a catheter assembly comprising an inner core tube 3000, an inner catheter 6000, a stent loading structure, and an outer sheath. The inner core tube 3000 has an axially extending guidewire lumen, which is configured to allow a guidewire to pass through. The inner catheter 6000 has an axially extending catheter lumen, and the inner core tube 3000 is positioned within the catheter lumen. The outer sheath has an axially extending see-through lumen, and the inner core tube 3000, the inner catheter 6000, and the stent loading structure are all housed within the see-through lumen. The distal end of the inner core tube 3000 extends from the distal end of the inner catheter 6000, and the portion of the inner core tube 3000 extending from the distal end of the inner catheter 6000 is referred to as a loading section into which the valve stent 5000 can be loaded, i.e., the guide member 2000 indirectly loads the valve stent 5000 so that the valve stent 5000 is positioned between the inner core tube 3000 and the outer sheath. Continuing to refer to Figure 1, the inner core tube 3000 can be inserted into both the guide bore of the guide member 2000 and the fixed bore of the fixed member 1000. The inner core tube 3000 may be provided with a distal guide head 4000 on its distal side, which may have a tapered or similar shape to facilitate the advancement of the entire catheter assembly.

[0042] Furthermore, this specification provides delivery systems incorporating stent-loading structures or catheter assemblies. The structural details, functional principles, and technical advantages of the stent-loading structures and catheter assemblies have been described above and will not be repeated for brevity. For further details, please refer to the above description.

[0043] 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.

[0044] 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]

[0045] 1000 Fixing member 2000 Guide Member 3000 Inner core tube 4000 Distal Guide Head 5000 valve stent 6000 Internal Catheter 1000a distal fixation section 1000b Proximal fixation section 1100 Distal fixation part 1200 First connecting member 1300 Second connecting member 2000a Distal Guide Section 2000b Proximal Guide Section 2000c Transition Guide Section 2100 seal elements 2200 protrusion 2300 Unit Separator 2300a Unit separation space 5100 Branch section

Claims

1. A fixing member having an axially extending fixing bore, wherein the fixing bore is configured to insert an inner core tube, and the fixing member has a distal fixing portion configured to fix a valve stent, A guide member comprising an axially extending guide bore, wherein the guide bore is configured to insert the inner core tube, the proximal end of the guide member is coupled to the distal end of the fixing member such that the guide bore communicates with the fixing bore, and the guide member above the inner core tube is configured to support the valve stent, A separation member provided on the guide member and configured to support the multiple branch portions of the valve stent by separating them, A stent loading structure equipped with the following features.

2. A sealing element, wherein the sealing element is positioned on the guide member and configured to seal the gap between the guide bore of the guide member and the outer wall of the inner core tube, or The stent loading structure according to claim 1, comprising a projection, the projection being positioned on the inner wall of the guide bore and configured to make sealing contact with the outer wall of the inner core tube.

3. The guide member comprises a distal guide section and a proximal guide section, each of which is a cylindrical tube, the maximum outer diameter of the distal guide section is smaller than the minimum outer diameter of the proximal guide section, and / or The stent loading structure according to claim 1, wherein the fixing member comprises a distal fixing section and a proximal fixing section, each of the distal fixing section and the proximal fixing section being a cylindrical tube, and the maximum outer diameter of the distal fixing section is smaller than the minimum outer diameter of the proximal fixing section.

4. The separation member is provided in the proximal guide section and / or The stent loading structure according to claim 3, wherein a transition guide section is connected between the distal guide section and the proximal guide section, the transition guide section is a cylindrical tube, and the outer diameter of the transition guide section gradually increases from the distal end to the proximal end.

5. The stent loading structure according to claim 4, wherein the separating member comprises a plurality of unit separators arranged circumferentially around the outer wall of the proximal guide section, with unit separation spaces provided between adjacent unit separators, and configured to receive the branch portion of the valve stent.

6. The stent loading structure according to claim 5, wherein the unit separator is a separation plate, and the height of the unit separator relative to the outer wall of the proximal guide section increases from the distal end to the proximal end.

7. A first connecting member and a second connecting member are provided at the proximal end of the guide member and the distal end of the fixing member, respectively, and the proximal end of the guide member is connected to the distal end of the fixing member by the first connecting member and the second connecting member, or The stent loading structure according to claim 1, wherein the proximal end of the guide member is adhesively fixed to the distal end of the fixing member.

8. The first connecting member is a socket provided at the proximal end of the guide member, and the second connecting member is a plug provided at the distal end of the fixing member, the plug being inserted into the socket, or The stent loading structure according to claim 7, wherein the first connecting member is a threaded bore provided at the proximal end of the guide member, and the second connecting member is a threaded stem provided at the distal end of the fixing member, the threaded stem being screw-connected to the threaded bore.

9. An inner core tube having an axially extending guidewire lumen, wherein the guidewire lumen is configured to allow a guidewire to pass through, An inner catheter having an axially extending catheter lumen, wherein the inner core tube is positioned within the catheter lumen, and the distal end of the inner core tube extends from the distal end of the inner catheter, A stent loading structure according to any one of claims 1 to 8, wherein a section of the inner core tube extending from the inner catheter is inserted into the fixing bore of the fixing member and the guide bore of the guide member, An outer sheath having an axially extending see-through membrane, wherein the inner core tube, the inner catheter, and the stent loading structure are each disposed within the outer sheath, A catheter assembly comprising the above features.

10. A stent loading structure according to any one of claims 1 to 8, The catheter assembly according to claim 9, A delivery system equipped with the following features.

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