Valve fixation device and delivery system

Abstract

The invention relates to a valve fixing device and a conveying system, a first fixing body is provided with a first shaft hole which is axially through, the first fixing body is provided with a first limiting structure, the first limiting structure comprises a plurality of first limiting unit parts, the first limiting unit parts surround the first fixing body in the circumferential direction, and the first limiting unit parts fix a support rod; the second fixing body is provided with a second axial hole which is axially through, a second limiting structure is arranged on the second fixing body, the second limiting structure comprises a plurality of second limiting unit parts, and the second limiting unit parts are used for fixing the bracket hanging parts. The first fixing body can position the stent rod in the valve stent through the first limiting structure, so that the stent rod can be kept stable in the conveying process, unexpected movement such as axial sliding, displacement and disengagement does not occur, and unexpected movement such as circumferential sliding, displacement and disengagement does not occur either; and the phenomena of unevenness, deviation, dislocation and the like after the valve stent is loaded in the conveying system are effectively limited.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a valve fixing device and a delivery system. Background Art

[0002] Transcatheter valve replacement is a minimally invasive interventional treatment. It is mainly used to treat diseases such as heart valve degeneration and has attracted much attention in the medical industry. It can effectively reduce the risk of high trauma and has been rapidly promoted in clinical applications. The self-expanding valve stent used in transcatheter valve replacement is generally delivered to the target position in the body through a delivery system. In the process of fixing the self-expanding valve stent and its matching delivery system, the conventional method is to design a connecting mechanism on the stent rod of the self-expanding valve stent, such as a connecting ear, a connecting ring, etc., and the matching delivery system is provided with a fixing mechanism, such as a fixing groove, a fixing claw, etc., and the self-expanding valve stent can be positioned and assembled in the delivery system by assembling the connecting mechanism and the fixing mechanism.

[0003] However, after the self-expanding valve stent is loaded into its sheath structure, the fixing mechanism of the delivery system only fixes a small number of stent rods with connecting mechanisms in the self-expanding valve stent. This may easily lead to circumferential offset or displacement of the stent rods on the self-expanding valve stent without connecting mechanisms when the delivery system is recovered or pushed, as they are not restricted by the connection of the fixing mechanism. This may lead to risks of misalignment or even stacking of the stent rods, resulting in unexpected forces and deformations, and the risk of movement of the self-expanding valve stent during release, which may affect the progress of the operation. Summary of the invention

[0004] Based on this, it is necessary to provide a valve fixing device, an inner core tube structure, an inner catheter structure and a delivery system to address the above-mentioned technical problems.

[0005] The present application provides a valve fixing device for fixing a valve stent, wherein the valve stent comprises a plurality of stent rods, some of the stent rods have a stent hanging portion, and the valve fixing device further comprises:

[0006] A first fixing body, wherein the first fixing body has a first axial hole extending axially therethrough, and a first limiting structure is arranged on the first fixing body, wherein the first limiting structure comprises a plurality of first limiting unit parts, at least a part of the first limiting unit parts surround the first fixing body along a circumferential direction, and the first limiting unit parts are used to fix the stent rod of the valve stent;

[0007] A second fixed body, wherein the second fixed body has a second axial hole axially extending therethrough, a second limiting structure is arranged on the second fixed body, the second limiting structure comprises a plurality of second limiting unit parts, the second limiting unit parts are used to fix the bracket hanging part, and the second fixed body is connected to the first fixed body.

[0008] In one embodiment, the distal end of the second fixing body is detachably connected to the proximal end of the first fixing body.

[0009] In one embodiment, at least one of the first fixing body and the second fixing body has a positioning connection structure, and the first fixing body and the second fixing body are positioned and connected by the positioning connection structure, and the positioning connection structure is used to limit the relative movement of the first fixing body and the second fixing body; and / or,

[0010] The first limiting unit is a first limiting groove provided on the outer wall of the first fixed body; and / or,

[0011] The second limiting unit portion is a second limiting groove formed on the outer wall of the second fixing body.

[0012] In one embodiment, the positioning connection structure includes a snap-in groove and a snap-in protrusion, the snap-in groove and the snap-in protrusion are respectively located at the proximal end of the first fixing body and the distal end of the second fixing body, and the proximal end of the first fixing body is positioned and connected to the distal end of the second fixing body through the snap-in connection of the snap-in groove and the snap-in protrusion; and / or,

[0013] The outer wall of the first fixed body is provided with a plurality of blocking protrusions, the blocking protrusions surround the first fixed body along the circumferential direction, and the intervals between adjacent blocking protrusions are used to form the first limiting groove; and / or,

[0014] The second limiting groove comprises a main groove area and a distal groove opening located at a distal position of the main groove area, the distal groove opening is connected to the main groove area, and the width of the distal groove opening is smaller than the width of the main groove area; and / or,

[0015] The second limiting groove is axially opposite to the first limiting groove.

[0016] In one embodiment, the width of the first limiting groove gradually decreases in the direction from the distal end to the proximal end; and / or,

[0017] The width of the blocking protrusion gradually increases in the direction from the distal end to the proximal end; and / or,

[0018] The height of the blocking protrusion gradually increases in the direction from the distal end to the proximal end.

[0019] In one embodiment, the first fixing body has an avoidance portion, and the avoidance portion is used to avoid the valve support; and / or,

[0020] The second fixing body has a guide portion, and the guide portion is used to guide the outer sheath tube of the conveying system to be sleeved on the outside of the second fixing body.

[0021] In one embodiment, the first fixed body comprises a first pipe segment, a transition pipe segment and a second pipe segment, the diameter of the first pipe segment is smaller than the diameter of the second pipe segment, the diameter of the transition pipe segment gradually increases from the distal end to the proximal end, the proximal end of the first pipe segment is connected to the second pipe segment through the transition pipe segment, and the transition pipe segment is used to constitute the avoidance portion; and / or,

[0022] The proximal end of the second fixing body has an annular end portion, and the diameter of the annular end portion gradually decreases in a direction from the distal end to the proximal end.

[0023] The present application provides an inner core tube structure of a conveying system, the inner core tube structure comprising:

[0024] An inner core tube, wherein the inner core tube has an axially penetrating core tube inner cavity;

[0025] The first fixing body in the valve fixing device is detachably connected to the outside of the inner core tube.

[0026] The present application provides an inner catheter structure of a delivery system, the inner catheter structure comprising:

[0027] An inner catheter, wherein the inner catheter has an axially penetrating catheter lumen;

[0028] The valve fixing device, the first fixing body and the second fixing body are detachably connected, the second fixing body is connected to the distal end of the inner catheter, and the first axial hole of the first fixing body and the second axial hole of the second fixing body are connected to the catheter lumen of the inner catheter.

[0029] The present application provides a delivery system, the delivery system comprising:

[0030] An inner core tube, wherein the inner core tube has an axially penetrating core tube inner cavity;

[0031] An inner catheter, the inner catheter having an axially penetrating catheter lumen, the inner catheter being movably sleeved on the outside of the inner core tube;

[0032] The valve fixing device, the first fixing body is detachably connected to the outside of the inner core tube, the second fixing body is connected to the distal end of the inner catheter, and the first axial hole of the first fixing body and the second axial hole of the second fixing body are in communication with the catheter lumen of the inner catheter;

[0033] The outer sheath tube has an axially penetrating sheath tube inner cavity, and the outer sheath tube is movably sleeved on the outside of the inner catheter and the valve fixing device.

[0034] In the above-mentioned valve fixing device and delivery system, the first fixing body can use the multiple first limiting unit parts in the first limiting structure to position all the stent rods in the valve stent one by one, so that the stent rods in the valve stent can remain stable during the delivery process, and no unexpected movement such as axial and circumferential sliding, displacement, and disengagement will occur. It can effectively limit the occurrence of unevenness, offset, misalignment, etc. caused by delivery, loading, release or external factors after the valve stent is loaded in the delivery system. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 A schematic plan view of the structure of a valve fixing device provided in one embodiment of the present application.

[0036] Figure 2 A schematic diagram of the three-dimensional structure of a valve fixing device provided in one embodiment of the present application.

[0037] Figure 3 A schematic assembly diagram of a valve stent and a valve fixing device provided for one embodiment of the present application.

[0038] Figure 4 A schematic diagram of the assembly of a valve stent, a valve fixing device and an outer sheath provided in one embodiment of the present application.

[0039] Figure Number:

[0040] A, valve stent; A1, non-connected stent rod; A2, connected stent rod; A21, stent hanging part;

[0041] 1000, first fixed body; 2000, second fixed body; 3000, inner core tube; 4000, inner catheter; 5000, outer sheath tube;

[0042] 1100, first limiting structure; 1100a, first limiting unit; 1100b, blocking protrusion; 1000a, first pipe section; 1000b, transition pipe section; 1000c, second pipe section;

[0043] 2100, second limiting structure; 2100a, second limiting unit; 2100a1, main groove area; 2100a2, distal notch; 2100b, annular end;

[0044] 1200, positioning connection structure; 1200a, snap-fit ​​groove; 1200b, snap-fit ​​protrusion. DETAILED DESCRIPTION

[0045] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0046] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0047] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0048] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0049] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0050] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0051] In order to more clearly describe the structure of the valve fixing device, the term "distal end" is defined here to mean the end away from the operator during the surgical operation, and the term "proximal end" is defined here to mean the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those commonly understood by technicians in the technical field of this application. The terms used in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0052] See also Figures 1 to 4 As shown, an embodiment of the present application provides a valve fixing device for fixing a valve stent A, the valve stent A includes a plurality of stent rods, some of the stent rods have a stent hanging portion A21, the valve fixing device includes a first fixing body 1000 and a second fixing body 2000, the first fixing body 1000 has a first axial hole axially extending therethrough, a first limiting structure 1100 is arranged on the first fixing body 1000, the first limiting structure 1100 includes a plurality of first limiting unit portions 1100a, at least a portion of the first limiting unit portions 1100a surrounds the first fixed body 1000 along the circumferential direction, the first limiting unit part 1100a is used to fix the stent rod of the valve stent A, the second fixed body 2000 has a second axial hole axially passing through, the second fixed body 2000 is provided with a second limiting structure 2100, the second limiting structure 2100 includes a plurality of second limiting unit parts 2100a, the second limiting unit part 2100a is used to fix the stent hanging part A21 of the valve stent A, and the second fixed body 2000 is used to be connected with the first fixed body 1000.

[0053] The specific structure of the first limiting structure 1100 and the second limiting structure 2100 can be adjusted and set according to the number of stent rods included in the valve stent A. For example, when the valve stent A is fixed using a valve fixing device, only a part of the stent rods included in the valve stent A can be fixed, or all the stent rods included in the valve stent A can be fixed as required, which is not limited here.

[0054] When the valve fixing device only fixes a part of the stent rods included in the valve stent A, part of the first limiting unit part 1100a can be arranged circumferentially around the first fixing body 1000 according to the fixing requirements, and part of the first limiting unit part 1100a correspondingly fixes the part of the stent rod that needs to be fixed on the valve stent A, and at the same time, the second limiting unit part 2100a also correspondingly fixes part of the stent hanging part A21 of the valve stent A. When the valve fixing device fixes all the stent rods included in the valve stent A, all the first limiting unit parts 1100a can circumferentially surround the first fixing body 1000, all the first limiting unit parts 1100a are used to fix all the stent rods of the valve stent A one-to-one, all the second limiting unit parts 2100a are used to fix all the stent hanging parts A21 of the valve stent A one-to-one, and the second fixing body 2000 is used to connect with the first fixing body 1000.

[0055] The first fixing body 1000 and the second fixing body 2000 can both be in a shape suitable for assembling the valve stent A. For example, the first fixing body 1000 and the second fixing body 2000 can be in a substantially cylindrical structure so that the valve stent A can be fixed on the outside of the first fixing body 1000 and the second fixing body 2000 in a contracted state. Figure 2As shown, the first fixing body 1000 and the second fixing body 2000 are cylindrical structures. The first fixing body 1000 and the second fixing body 2000 can be fixedly connected to each other or detachably connected to each other. When the first fixing body 1000 and the second fixing body 2000 are in a connected state, the first limiting structure 1100 and the second limiting structure 2100 located on the first fixing body 1000 and the second fixing body 2000 can respectively assemble multiple stent rods on the valve stent A, wherein all the stent rods included in the valve stent A can be divided into two categories, one is a non-connected stent rod A2, that is, a stent rod not equipped with a stent hanging portion A21, and the other is a non-connected stent rod A2. It is a connecting stent rod A2, which has a stent hanging portion A21 such as a hanging ear. The inner catheter 4000 of the conveying system is connected to the connecting stent rod A2 by means of the stent hanging portion A21. Generally, the number of non-connected stent rods A2 will be greater than the number of connected stent rods A2, that is, the stent hanging portion A21 will be set on a small number of stent rods of the valve stent A. For example, the stent hanging portion A21 is set on two stent rods of the valve stent A, and the inner catheter 4000 of the conveying system is connected to the connecting stent rod A2 by means of two symmetrically set stent hanging portions A21.

[0056] The first limiting structure 1100 of the first fixed body 1000 includes a plurality of first limiting unit portions 1100a circumferentially arranged around the first fixed body 1000, and a plurality of stent rods in the valve stent A in the contracted state are also circumferentially arranged. Therefore, the first fixed body 1000 can use the plurality of first limiting unit portions 1100a in the first limiting structure 1100 to correspondingly position part of the stent rods or all of the stent rods in the valve stent A, so that the stent rods in the valve stent A can remain stable during the transportation process, without unexpected movements such as axial sliding, displacement, and disengagement, and without unexpected movements such as circumferential sliding, displacement, and disengagement. This can effectively limit the occurrence of unevenness, offset, misalignment, and the like caused by transportation, loading, release, or external factors after the valve stent A is loaded in the transportation system.

[0057] A second limiting structure 2100 is arranged on the second fixed body 2000, and the second limiting structure 2100 includes a plurality of second limiting unit parts 2100a. The second fixed body 2000 is connected to the first fixed body 1000, and can be used to simultaneously mount the valve stent A. The second limiting unit part 2100a is used to correspondingly position part of the stent hanging part A21 or all of the stent hanging part A21 of the valve stent A, to ensure that the valve stent A will not produce unexpected movement, so as to provide external force transmission when the conveying system loads and releases the valve stent A, so that the stent rod with the stent hanging part A21 in the valve stent A can not only be connected with the inner catheter 4000, but also can further maintain stability during the conveying process, without axial sliding, displacement, fall-out and other unexpected movements, and circumferential sliding, displacement, fall-out and other unexpected movements, which can effectively limit the occurrence of unevenness, offset, dislocation and the like caused by conveying, loading, release or external factors after the valve stent A is loaded in the conveying system.

[0058] The first fixing body 1000 and the second fixing body 2000 can be connected in a variety of ways, for example, the first fixing body 1000 and the second fixing body 2000 are connected by any means such as riveting, bonding, and threading, and are used to cover the valve stent A at the same time. Figure 2 As shown, in one embodiment, at least one of the first fixed body 1000 and the second fixed body 2000 may have a positioning connection structure 1200, and the first fixed body 1000 and the second fixed body 2000 are positioned and connected by the positioning connection structure 1200. The positioning connection structure 1200 is used to limit the relative movement of the first fixed body 1000 and the second fixed body 2000. The positioning connection structure 1200 may include a snap-in groove 1200a and a snap-in protrusion 1200b. The snap-in groove 1200a and the snap-in protrusion 1200b are respectively located at the proximal end of the first fixed body 1000 and the distal end of the second fixed body 2000. The proximal end of the first fixed body 1000 is positioned and connected to the distal end of the second fixed body 2000 by snapping the snap-in groove 1200a and the snap-in protrusion 1200b, so that the first fixed body 1000 and the second fixed body 2000 can be mutually interlocked.

[0059] The first limiting unit portion 1100a can be in various structures, for example, the first limiting unit portion 1100a can be in various structures such as a groove, a buckle, etc. Figure 2 As shown, the first limiting unit portion 1100a may be a first limiting groove opened on the outer wall of the first fixed body 1000. The first limiting groove may be formed by directly opening a groove on the outer wall of the first fixed body 1000, or by referring to Figure 2As shown, the outer wall of the first fixed body 1000 may be provided with a plurality of blocking protrusions 1100b, and the plurality of blocking protrusions 1100b surround the first fixed body 1000 along the circumferential direction. Since spaces are formed between adjacent blocking protrusions 1100b, the spaces formed by the blocking protrusions 1100b can constitute a first limiting groove. Those skilled in the art may select a suitable construction method according to requirements, which is not limited here.

[0060] Continue reading Figure 2 As shown, the width of the first limiting groove gradually decreases in the direction from the distal end to the proximal end, so that the distal opening of the first limiting groove is a relatively wide opening, and the proximal opening of the first limiting groove is a relatively narrow narrow opening. When the valve stent A is loaded from the distal end to the proximal end, the wide opening at the distal end of the first limiting groove can guide the stent rod of the valve stent A to gradually narrow while moving axially until it reaches the narrow opening at the proximal end of the first limiting groove to form a stable fixation, which has the function of limiting the valve stent A from performing unexpected circumferential movement. The gradual change of the width of the first limiting groove can be achieved through a variety of structures, such as directly constructing a gradual change in the width of the groove when grooving.

[0061] See also Figure 2 As shown, the first limiting groove is composed of the spacing space formed by the blocking protrusion 1100b, and the width of the blocking protrusion 1100b can be limited to gradually increase in the direction from the distal end to the proximal end. Because the area of ​​the outer wall of the first fixed body 1000 is fixed, when the width of the blocking protrusion 1100b gradually increases in the direction from the distal end to the proximal end, the spacing space between adjacent blocks will gradually decrease in the direction from the distal end to the proximal end, thereby making the width of the first limiting groove gradually decrease in the direction from the distal end to the proximal end. At the same time, the height of the blocking protrusion 1100b can also gradually increase in the direction from the distal end to the proximal end. For example, the distal end of the blocking protrusion 1100b is basically flush with the outer wall of the first fixed body 1000, or slightly higher than the outer wall of the first fixed body 1000 by 0.1 mm. After gradually rising, the highest point of the proximal end of the blocking protrusion 1100b is slightly smaller than the inner diameter of the inner catheter 4000, that is, there is a certain slight gap between the inner wall of the inner catheter 4000. The highest point of the proximal end of the blocking protrusion 1100b can be slightly higher than the bracket hanging part A21 such as the hanging ear, which plays a role of gradual guidance.

[0062] The second limiting unit portion 2100a can be in various structures, for example, the second limiting unit portion 2100a can be in various structures such as a groove, a buckle, etc. Figure 2 As shown, the second limiting unit portion 2100a can be a second limiting groove opened on the outer wall of the second fixed body 2000, and the first limiting groove can be directly formed by slotting the outer wall of the first fixed body 1000 or by blocking in a manner similar to the first limiting groove, see Figure 2As shown, the second limiting groove includes a main groove area 2100a1 and a distal groove 2100a2 located at the distal position of the main groove area 2100a1, and the distal groove 2100a2 is connected to the main groove area 2100a1. The width of the distal groove 2100a2 is smaller than the width of the main groove area 2100a1, so that the entire second limiting groove can adapt to the shape and size of the bracket hanging part A21 such as the hanging ear.

[0063] Each second limiting groove is axially opposite to one of the first limiting grooves, so that the stent rod with the stent hanging part A21 in the valve stent A can be assembled on the first limiting groove and the second limiting groove accordingly. The specific corresponding position and size between the first limiting groove and the second limiting groove can be determined according to the specific form of the stent rod and the stent hanging part A21 on the valve stent A, and no limitation is made here.

[0064] See also Figure 2 As shown, in one embodiment, the first fixing body 1000 has an avoidance portion, and the avoidance portion is used to avoid the valve support A. Therefore, when the template support is assembled on the first fixing body 1000, based on the avoidance portion on the first fixing body 1000, the area where the avoidance portion exists can be prevented from contacting the valve support A and touching the leaflets, thereby avoiding damage to the leaflets. The avoidance portion can be formed by a structure such as a depression or a groove, see Figure 2 As shown, in one embodiment, the first fixed body 1000 includes a first tube segment 1000a, a transition tube segment 1000b and a second tube segment 1000c. The diameter of the first tube segment 1000a is smaller than the diameter of the second tube segment 1000c. The diameter of the transition tube segment 1000b gradually increases from the distal end to the proximal end. The proximal end of the first tube segment 1000a is connected to the second tube segment 1000c through the transition tube segment 1000b. The transition tube segment 1000b has a gradual diameter and can therefore be used to form an avoidance portion to avoid damaging the leaflets.

[0065] See also Figure 2 As shown, the second fixed body 2000 has a guide portion, which is used to guide the outer sheath tube 5000 of the delivery system to be sleeved on the outside of the second fixed body 2000. When the outer sheath tube 5000 is sleeved on the first fixed body 1000, the second fixed body 2000 and the valve stent A from the proximal end to the distal end, the guide portion can guide the axial movement of the outer sheath tube 5000, so that the outer sheath tube 5000 can be sleeved more smoothly. The guide portion can be a guide slope, a guide groove, a guide protrusion and other structures, for example, see Figure 2As shown, the proximal end of the second fixing body 2000 has an annular end 2100b, the diameter of which gradually decreases in the direction from the distal end to the proximal end, and the inclined surface formed by the outer wall of the annular end 2100b constitutes a guide portion. The end of the outer sheath tube 5000 can also be constructed with a slope, so that the end of the outer sheath tube 5000 can form a guiding fit with the guide portion.

[0066] The present application provides an inner core tube 3000 structure of a delivery system, the inner core tube 3000 structure includes an inner core tube 3000 and a first fixing body 1000 in a valve fixing device, the inner core tube 3000 has an axially through-core tube inner cavity, and the first fixing body 1000 is detachably connected to the outside of the inner core tube 3000, for example, by sleeve connection, bonding, clamping, welding, etc. The first fixing body 1000 can be made of a polymer material, and the first fixing body 1000 can be detachably assembled to the inner core tube 3000, for example, by bonding, threaded connection, riveting, etc., and connected to the inner core tube 3000.

[0067] The present application provides an inner catheter 4000 structure of a delivery system, which includes an inner catheter 4000 and a valve fixing device. The inner catheter 4000 has an axially through-going catheter lumen, a first fixing body 1000 and a second fixing body 2000 are detachably connected, the second fixing body 2000 is connected to the distal end of the inner catheter 4000, and a first axial hole of the first fixing body 1000 and a second axial hole of the second fixing body 2000 are connected to the catheter lumen of the inner catheter 4000.

[0068] See also Figure 3 and Figure 4 As shown, the present application provides a delivery system, which includes an inner core tube 3000, an inner catheter 4000, a valve fixing device and an outer sheath tube 5000, the inner core tube 3000 has an axially through core tube lumen, the inner catheter 4000 has an axially through catheter lumen, the inner catheter 4000 is movably sleeved on the outside of the inner core tube 3000, the first fixed body 1000 is detachably connected to the outside of the inner core tube 3000, for example, by sleeve connection, bonding, clamping, welding and other optional methods, the second fixed body 2000 is connected to the distal end of the inner catheter 4000, the first axial hole of the first fixed body 1000 and the second axial hole of the second fixed body 2000 are connected to the catheter lumen of the inner catheter 4000, the outer sheath tube 5000 has an axially through sheath tube lumen, and the outer sheath tube 5000 is movably sleeved on the outside of the inner catheter 4000 and the valve fixing device.

[0069] The operator may first withdraw the outer sheath tube 5000 to expose the first fixed body 1000 and the second fixed body 2000 in sequence, so that the exposure of the first fixed body 1000 and the second fixed body 2000 can meet the assembly of the valve stent A. Among them, when the valve stent A is assembled relative to the first fixed body 1000 and the second fixed body 2000, the operator may choose to use an adapted stent loading tool to narrow the valve stent A, so that the valve stent A can be easily assembled on the first fixed body 1000 and the second fixed body 2000 after narrowing, for example, the valve stent A is narrowed to be slightly larger than or roughly equal to the overall outer diameter of the second fixed body 2000. At this time, the ear on the valve stent A is first installed and embedded in the second limiting unit part 2100a of the second fixed body 2000, and then the outer sheath tube 5000 is pushed axially, and the outer sheath tube 5000 is used to first wrap the second fixed body 2000 embedded in the ear. Continue to push the outer sheath tube 5000, the stent rod of the valve stent A will be guided and stored in the first limiting unit 1100a, and as the outer sheath tube 5000 continues to be pushed, the outer sheath tube 5000 will also immediately wrap around the first fixed body 1000, so that the first fixed body 1000 is also loaded and wrapped into the outer sheath tube 5000 after the second fixed body 2000.

[0070] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0071] The above embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A valve fixing device for fixing a valve stent, wherein the valve stent comprises a plurality of stent rods, some of the stent rods have a stent hanging portion, characterized in that: The valve fixing device further comprises: A first fixing body, wherein the first fixing body has a first axial hole extending axially therethrough, and a first limiting structure is arranged on the first fixing body, wherein the first limiting structure comprises a plurality of first limiting unit parts, at least a part of the first limiting unit parts surround the first fixing body along a circumferential direction, and the first limiting unit parts are used to fix the stent rod of the valve stent; A second fixed body, wherein the second fixed body has a second axial hole axially extending therethrough, a second limiting structure is arranged on the second fixed body, the second limiting structure comprises a plurality of second limiting unit parts, the second limiting unit parts are used to fix the bracket hanging part, and the second fixed body is connected to the first fixed body.

2. The valve fixing device according to claim 1, characterized in that: The distal end of the second fixing body is detachably connected to the proximal end of the first fixing body.

3. The valve fixing device according to claim 1, characterized in that: At least one of the first fixing body and the second fixing body has a positioning connection structure, the first fixing body and the second fixing body are positioned and connected by the positioning connection structure, and the positioning connection structure is used to limit the relative movement of the first fixing body and the second fixing body; and / or, The first limiting unit is a first limiting groove formed on the outer wall of the first fixed body; and / or, The second limiting unit portion is a second limiting groove formed on the outer wall of the second fixing body.

4. The valve fixing device according to claim 3, characterized in that: The positioning connection structure comprises a snap-in groove and a snap-in protrusion, wherein the snap-in groove and the snap-in protrusion are respectively located at the proximal end of the first fixing body and the distal end of the second fixing body, and the proximal end of the first fixing body is positioned and connected with the distal end of the second fixing body through the snap-in connection between the snap-in groove and the snap-in protrusion; and / or, The outer wall of the first fixed body is provided with a plurality of blocking protrusions, the blocking protrusions surround the first fixed body along the circumferential direction, and the intervals between adjacent blocking protrusions are used to form the first limiting groove; and / or, The second limiting groove comprises a main groove area and a distal groove opening located at a distal position of the main groove area, the distal groove opening is connected to the main groove area, and the width of the distal groove opening is smaller than the width of the main groove area; and / or, The second limiting groove is axially opposite to the first limiting groove.

5. The valve fixing device according to claim 4, characterized in that: The width of the first limiting groove gradually decreases in the direction from the distal end to the proximal end; and / or, The width of the blocking protrusion gradually increases in the direction from the distal end to the proximal end; and / or, The height of the blocking protrusion gradually increases in the direction from the distal end to the proximal end.

6. The valve fixing device according to claim 1, characterized in that: The first fixing body has an avoidance portion, and the avoidance portion is used to avoid the valve support; and / or, The second fixing body has a guide portion, and the guide portion is used to guide the outer sheath tube of the conveying system to be sleeved onto the outside of the second fixing body.

7. The valve fixing device according to claim 6, characterized in that: The first fixed body comprises a first pipe segment, a transition pipe segment and a second pipe segment, the diameter of the first pipe segment is smaller than the diameter of the second pipe segment, the diameter of the transition pipe segment gradually increases from the distal end to the proximal end, the proximal end of the first pipe segment is connected to the second pipe segment through the transition pipe segment, and the transition pipe segment is used to constitute the avoidance portion; and / or, The proximal end of the second fixing body has an annular end portion, and the diameter of the annular end portion gradually decreases in a direction from the distal end to the proximal end.

8. An inner core tube structure of a conveying system, characterized in that: The inner core tube structure comprises: An inner core tube, wherein the inner core tube has an axially penetrating core tube inner cavity; The first fixing body in the valve fixing device according to any one of claims 1 to 7 is detachably connected to the outside of the inner core tube.

9. An inner catheter structure of a delivery system, characterized in that: The inner catheter structure comprises: An inner catheter, wherein the inner catheter has an axially penetrating catheter lumen; According to the valve fixing device as described in any one of claims 1-7, the first fixing body is detachably connected to the second fixing body, the second fixing body is connected to the distal end of the inner catheter, and the first axial hole of the first fixing body and the second axial hole of the second fixing body are connected to the catheter lumen of the inner catheter.

10. A conveying system, characterized in that: The delivery system comprises: An inner core tube, wherein the inner core tube has an axially penetrating core tube inner cavity; An inner catheter, the inner catheter having an axially penetrating catheter lumen, the inner catheter being movably sleeved on the outside of the inner core tube; The valve fixing device according to any one of claims 1 to 7, wherein the first fixing body is detachably connected to the outside of the inner core tube, the second fixing body is connected to the distal end of the inner catheter, and the first axial hole of the first fixing body and the second axial hole of the second fixing body are in communication with the catheter lumen of the inner catheter; The outer sheath tube has an axially penetrating sheath tube inner cavity, and the outer sheath tube is movably sleeved on the outside of the inner catheter and the valve fixing device.

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