Heart valve delivery system

Abstract

The present application discloses a cardiac valve delivery system with precise positioning and easy operation, which includes a catheter system for delivering an external cardiac valve to a target position, a release device for releasing the cardiac valve, and a positioning device for precisely positioning the cardiac valve. The positioning device may include a central positioning structure, a circumferential positioning structure, and an axial positioning structure, and the proximal end of the circumferential positioning structure and the distal end of the external threaded sleeve of the axial positioning structure are connected by a detachable first pin. The cardiac valve delivery system described herein has precise positioning and is easy to operate.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a heart valve delivery system. Background Art

[0002] Due to the many advantages of transcatheter surgery, such as less trauma and faster recovery, more and more surgeries are starting to use the transcatheter approach. The aortic valve replacement has also changed from the early surgical incision method to the transcatheter replacement of the aortic valve.

[0003] The replacement of the aortic valve usually needs to be completed with the help of a heart valve and a heart valve delivery system. With the continuous innovation of heart valves, higher requirements are also put forward for the heart valve delivery system. Specifically, the heart valve delivery system should not only ensure that the heart valve can be input to the accurate position and angle in the aorta, provide reasonable space for the expansion of the heart valve, but also ensure that no human tissue is damaged during the delivery process.

[0004] Therefore, there is a continuous need in this field to develop a heart valve delivery system with accurate positioning and easy operation. Summary of the Invention

[0005] The purpose of the present application is to provide a heart valve delivery system with accurate positioning and easy operation. The heart valve delivery system described herein may include a catheter system for delivering an external heart valve to a target position, a release device for releasing the heart valve, and a positioning device for accurately positioning the heart valve. The positioning device may include a central positioning structure, a circumferential positioning structure, and an axial positioning structure, and the proximal end of the circumferential positioning structure and the distal end of the external threaded sleeve of the axial positioning structure are connected by a detachable first pin. Specifically, the proximal end of the circumferential positioning structure may include a first pin hole, the distal end of the axial positioning structure may include a second pin hole that cooperates with the first pin hole, and the first pin hole and the second pin hole are aligned only at specific positions to form a through hole suitable for accommodating the pin. This can limit the circumferential rotation of the axial positioning structure relative to the circumferential positioning structure. In addition, a scale may be provided on the external pin hole to accurately display the rotation angle of the tubular housing, thereby accurately positioning the angle of the heart valve.

[0006] To achieve the above object, the present invention provides the following technical solutions.

[0007] In a first aspect, the present application provides a heart valve delivery system, which includes a catheter system for delivering an external heart valve to a target position, a release device for releasing the heart valve, and a positioning device for precisely positioning the heart valve. In this embodiment, the catheter system includes an inner tube, a middle tube, and an outer tube that are sequentially sleeved. The proximal end of the heart valve is configured to be clamped between the inner tube and the middle tube, and the distal end of the heart valve is configured to be clamped between the middle tube and the outer tube. In this embodiment, the release device includes a proximal end release structure and a distal end release structure. The proximal end release structure is used to control the axial movement of the outer tube, and the distal end release structure is used to control the axial movement of the inner tube. In this embodiment, the positioning device includes a central positioning structure, a circumferential positioning structure, and an axial positioning structure. The central positioning structure moves the heart valve to the central axis of the aorta by adjusting the curvature of the distal end of the heart valve delivery system. The circumferential positioning structure is fixedly connected to the catheter system and is configured to drive the catheter system to rotate around its axis so that the positioning member of the heart valve is axially aligned with the sinus bottom. The axial positioning structure is used to adjust the axial position of the heart valve, including an external thread sleeve and a tubular guide member, and the external thread sleeve is configured to be axially movable relative to the tubular guide member but not circumferentially movable. In this embodiment, the proximal end of the external thread sleeve and the distal end of the tubular guide member are connected by a driving nut, and the driving nut is used to control the axial movement of the external thread sleeve relative to the tubular guide member. In this embodiment, the proximal end of the circumferential positioning structure and the distal end of the external thread sleeve of the axial positioning structure are detachably connected.

[0008] In an embodiment of the first aspect, the proximal end of the circumferential positioning structure and the distal end of the external thread sleeve of the axial positioning structure are connected by a detachable first pin.

[0009] In an embodiment of the first aspect, the circumferential positioning structure includes: a tubular housing, an anti-middle-tube rotating tube, and an anti-outer-tube rotating tube. In this embodiment, the tubular housing includes a housing outer surface, a housing inner surface, and a housing wall extending between the housing outer surface and the housing inner surface, wherein at least a portion of the conduit system passes through the hollow interior of the tubular housing. In this embodiment, one end of the anti-middle-tube rotating tube is in fluid communication with the interior space of the first stepped sealing sleeve, and the other end abuts against the tubular housing and extends through the housing inner surface of the tubular housing. The anti-middle-tube rotating tube also serves as the drain tube for the middle tube to discharge the air between the middle tube and the inner tube. In this embodiment, one end of the anti-outer-tube rotating tube is in fluid communication with the interior space of the second stepped sealing sleeve, and the other end abuts against the tubular housing and extends through the housing inner surface of the tubular housing. The anti-outer-tube rotating tube also serves as the drain tube for the outer tube to discharge the air between the outer tube and the middle tube. In this embodiment, the interior space of the first stepped sealing sleeve, the outer surface of the inner tube, and the inner surface of the middle tube form a first cavity having an opening at the proximal end of the middle tube. The interior space of the second stepped sealing sleeve, the outer surface of the middle tube, and the inner surface of the outer tube form a second cavity having an opening at the proximal end of the outer tube. And the first stepped sealing sleeve and the second stepped sealing sleeve are arranged inside the tubular housing along the direction from the distal end to the proximal end. In this embodiment, the tubular housing is configured such that when the tubular housing rotates circumferentially, the conduit system rotates circumferentially synchronously with the tubular housing.

[0010] In an embodiment of the first aspect, the first stepped sealing sleeve includes a first sleeve and a second sleeve fixedly connected. The first sleeve is closer to the distal end of the tubular housing than the second sleeve, and the distal end of the first sleeve includes a sealing structure. The diameter of the second sleeve is smaller than that of the first sleeve, and the distal end of the middle tube is fixedly connected to the hollow interior space of the second sleeve.

[0011] In an embodiment of the first aspect, the second stepped sealing sleeve includes a third sleeve, a fourth sleeve, and a fifth sleeve fixedly connected. The fourth sleeve is closer to the distal end of the tubular housing than the third sleeve, and the fifth sleeve is closer to the distal end of the tubular housing than the fourth sleeve. The distal end of the third sleeve includes a sealing structure. The diameter of the fourth sleeve is smaller than that of the third sleeve, and the diameter of the fifth sleeve is smaller than that of the fourth sleeve. And the distal end of the outer tube is fixedly connected to the hollow interior space of the fifth sleeve.

[0012] In an embodiment of the first aspect, the proximal end of the tubular housing includes first pin holes circumferentially spaced apart, the distal end of the external thread sleeve includes second pin holes adapted to cooperate with the first pin holes, and the first pin holes and the second pin holes are configured to coincide only at specific positions to form a through hole adapted to receive the pins. In this embodiment, the first pin holes are external pin holes and the second pin holes are internal pin holes, or the first pin holes are internal pin holes and the second pin holes are external pin holes.

[0013] In an embodiment of the first aspect, the number of the first pin holes and the second pin holes is different.

[0014] In an embodiment of the first aspect, a scale is provided beside the external pin holes and corresponds to the external pin holes.

[0015] In an embodiment of the first aspect, the distal end release structure of the release device includes a release plate, a driven ring and a driving ring. The driven ring is arranged around the driving ring and is used to drive the release plate to move axially under the drive of the driving ring. The release plate is in a butterfly shape, and both ends of the release plate extend through the tubular housing and are smoothly connected to the driven ring at the center. In this embodiment, the driving ring is arranged around the outer periphery of the cylindrical outer tube connection part and cooperates with the driven ring to drive the tubular housing to move along the axial direction of the tubular housing.

[0016] In an embodiment of the first aspect, the release device is further provided with a radial limit structure, which includes a plurality of guide rods arranged parallel to the axial direction of the tubular housing, so that the driven ring cannot move radially.

[0017] In an embodiment of the first aspect, the tubular housing includes a release plate anti-misoperation structure, which includes a transverse through hole and a longitudinal through hole communicated with each other arranged on the tubular housing. The transverse through hole extends a first distance along the axial direction of the rotation axis, and the longitudinal through hole extends a second distance along the axial direction of the rotation axis. The first distance is configured to limit the axial movement of the release plate along the rotation axis, and the second distance is configured to be suitable for the release plate to move axially along the rotation axis, and the first distance is less than the second distance.

[0018] In an embodiment of the first aspect, the proximal end release structure of the release device includes a hollow central shaft and a plurality of release disks spaced around the hollow central shaft. The central shaft includes a first hollow channel and a second hollow channel adapted for a guide wire to pass through. The diameter of the first hollow channel is smaller than that of the second hollow channel. The first hollow channel is closer to the distal end of the release device than the second hollow channel, and the inner tube is fixedly connected within the second hollow channel.

[0019] In an embodiment of the first aspect, the proximal end of the proximal end release structure is sleeved within the distal end of the tubular housing, and the maximum radial dimension of the proximal end of the proximal end release structure is greater than the maximum dimension of the distal end opening of the tubular housing, for restricting the maximum axial movement distance of the proximal end release structure in the distal end direction.

[0020] In an embodiment of the first aspect, a detachable engaging member is provided between the proximal end sleeve of the proximal end release structure and the distal end of the tubular housing, for restricting the movement of the proximal end release structure in the axial direction.

[0021] In an embodiment of the first aspect, the distal end of the inner tube is provided with an outwardly folded structure to form a ring, and the distal end of the middle tube is provided with a first outwardly expanding structure, and the proximal end of the heart valve is clamped between the ring and the outwardly expanding structure.

[0022] In an embodiment of the first aspect, the distal end of the outer tube is provided with a second outwardly expanding structure, and the connection between the middle tube and the second outwardly expanding structure includes a fixing ring, and the proximal end of the heart valve is clamped between the second outwardly expanding structure and the fixing ring to restrict its radial movement.

[0023] In an embodiment of the first aspect, the fixing ring is axially provided with at least one constriction groove communicating with the outside, which is clamped with the distal end of the heart valve to restrict the axial movement of the heart valve.

[0024] In the second aspect, the present application provides a method for delivering a heart valve using a heart valve delivery system.

[0025] Compared with the prior art, the beneficial effects of the present application are as follows:

[0026] (1) The heart valve delivery system has accurate positioning and is easy to operate;

[0027] (2) The tubular housing is provided with a misoperation prevention structure for the release plate, which restricts the axial movement of the release plate when the release plate does not need to move;

[0028] (3) The distal end of the middle tube includes a heart valve fixing ring for clamping the heart valve within the fixing ring, which can avoid damage to blood vessel tissues by the heart valve;

[0029] (4) When using the heart valve delivery system described in this article to deliver a heart valve, the proximal end (inflow end) of the heart valve is engaged by the inner tube and the middle tube, and the distal end (outflow end) of the heart valve is engaged by the middle tube and the outer tube. When releasing the heart valve, the proximal end of the heart valve is released by pushing the inner tube to the left, and the distal end of the heart valve is released by moving the outer tube backward. This can avoid damage to the valve or re-movement of the positioned valve during the process of pushing the competing products to the left (left ventricle side). BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The technical features and advantages of the present invention may be more fully understood by referring to the following detailed description in conjunction with the accompanying drawings, in which:

[0031] Figure 1 A schematic diagram showing a heart valve delivery system according to one embodiment of the present application;

[0032] Figure 2 show Figure 1 A partial enlarged view of point F in the middle;

[0033] Figure 3 show Figure 1 A partial enlarged view of point E in the middle;

[0034] Figure 4 show Figure 1 A partial enlarged view of the G in the middle;

[0035] Figure 5 A schematic structural diagram showing the cooperation between a tubular housing and a connector having an externally threaded sleeve according to an embodiment of the present application;

[0036] Figure 6 A front view showing a tubular housing according to one embodiment of the present application;

[0037] Figure 7 show Figure 6 Cross-sectional view of the middle DD section;

[0038] Figure 8 A schematic diagram showing the internal structure of a tubular housing according to an embodiment of the present application;

[0039] Figure 9 A schematic diagram showing a structure for preventing misoperation of a release plate according to an embodiment of the present application is shown;

[0040] Figure 10 An exploded view showing a tubular housing according to one embodiment of the present application;

[0041] Figure 11 A schematic diagram showing an outer tube sealing structure according to an embodiment of the present application;

[0042] Figure 12Show an exploded view of a tubular guide according to an embodiment of the present application;

[0043] Figure 13 Show an exploded view of a tubular guide and a conical guide structure according to an embodiment of the present application;

[0044] Figure 14 Show an exploded view of a tubular guide and a conical guide structure from another angle according to an embodiment of the present application;

[0045] Figure 15 Show a schematic diagram of a conical guide structure according to an embodiment of the present application;

[0046] Figure 16 Show a schematic diagram of the internal structure of a heart valve delivery system according to another embodiment of the present application;

[0047] Figure 17 Show Figure 16 A partial enlarged view at position B in

[0048] Figure 18 Show a schematic diagram of the structure of a threaded tube according to an embodiment of the present application;

[0049] Figure 19 Show a top view of a heart valve delivery system according to another embodiment of the present application;

[0050] Figure 20 Show Figure 19 A sectional view taken along the plane A-A in

[0051] Figure 21 Show Figure 20 A partial enlarged view at position M in

[0052] Figure 22 Show Figure 19 A schematic diagram of the distal end in

[0053] Figure 23 Show a schematic diagram of a heart valve according to an embodiment. Detailed embodiments

[0054] Unless otherwise defined, technical terms or scientific terms used in this specification and claims shall have the ordinary meaning as understood by those of ordinary skill in the technical field to which the present invention pertains.

[0055] In the description of the present invention, it should be understood that the orientation or positional relationships indicated by the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. are based on the orientation or positional relationships shown in the drawings. These are only for the convenience of describing the present invention and simplifying the description, and do 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 thus should not be construed as a limitation to the present invention.

[0056] In addition, the terms "first", "second", etc. are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first", "second", etc. may explicitly or implicitly include one or more of such features. In the description of the present invention, unless otherwise stated, the meaning of "a plurality" is two or more.

[0057] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "mounted", "connected", and "coupled" should be understood in a broad sense. For example, it may be a connection, a detachable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be a direct connection or an indirect connection through an intermediate medium, and it may be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood through specific circumstances.

[0058] As described herein, when describing a heart valve, a release tip, a tubular housing, an external threaded sleeve, a tubular housing, a tubular guide, a bending structure, a guide wire, and a catheter system, etc., "proximal" refers to the side of the catheter system when the heart valve is in an extended state or the side in the direction of the end manipulated by the user. Correspondingly, "distal" refers to the side away from the catheter system when the heart valve is in an extended state or the side away from the direction of the end manipulated by the user. In the present application, when describing the heart valve, "proximal end" refers to the side close to the apex of the heart when the heart valve is in an extended state. Correspondingly, "distal end" refers to the side away from the apex of the heart when the heart valve is in an extended state. Since the heart valve described herein is delivered through the aorta by catheter, the distal end and the proximal end of the heart refer to the same position, and the proximal end and the distal end refer to the same position.

[0059] Embodiment 1

[0060] This embodiment provides a heart valve delivery system 100.

[0061] First, refer to Figures 1 - 4, along the direction from the distal end to the proximal end, the heart valve delivery system 100 of this embodiment may sequentially include a release end 1, a tubular housing 2, an external thread sleeve 3, a tubular guide 4, and a tapered guide structure 10. The proximal end of the release end 1 may be sleeved within the distal end opening of the tubular housing 2. The proximal end of the tubular housing 2 and the distal end of the external thread sleeve 3 may be connected by a first pin 20. The proximal end of the external thread sleeve 3 and the distal end of the tubular guide 4 may be connected by a drive nut 8. The proximal end of the tubular guide 4 may be connected to the distal end of the tapered guide structure 10 by a connection nut 9. The heart valve delivery system 100 may further include a bending adjustment device 5, and the proximal end of the bending adjustment device 5 is fixedly connected to the tubular guide 4.

[0062] In addition, the heart valve delivery system 100 may further include a catheter system. The catheter system can be used to deliver an external heart valve to a target position. The catheter system includes an inner tube, a middle tube, and an outer tube that are sequentially sleeved. The proximal end of the heart valve is configured to be snap-fitted between the inner tube and the middle tube, and the distal end of the heart valve is configured to be snap-fitted between the middle tube and the outer tube. The inner tube, the middle tube, and the outer tube in the catheter system all extend a predetermined distance through the proximal end of the tapered guide structure 10.

[0063] In one embodiment, the heart valve delivery system 100 includes a release device for releasing the heart valve. The release device includes a proximal end release structure and a distal end release structure. The proximal end release structure is used to control the axial movement of the outer tube, and the distal end release structure is used to control the axial movement of the inner tube. In this embodiment, the proximal end release structure may be the release end 1 for releasing the proximal end of the heart valve. In addition, the distal end release structure may include a release plate 7 disposed inside the tubular housing 2 and protruding from the outside of the tubular housing 2 for releasing the distal end of the heart valve.

[0064] In one embodiment, the heart valve delivery system may include a positioning device for precisely positioning the heart valve. The positioning device includes a central positioning structure, a circumferential positioning structure, and an axial positioning structure. The circumferential positioning structure is fixedly connected to the catheter system and is configured to drive the catheter system to rotate around its axis so that the positioning member of the heart valve is axially aligned with the sinus bottom. The axial positioning structure is used to adjust the axial position of the heart valve and includes an external thread sleeve and a tubular guide member, and the external thread sleeve is configured to axially move relative to the tubular guide member but not circumferentially move. In this embodiment, the central positioning structure may include a bending adjustment device 5 for moving the heart valve to the central axis of the aorta by adjusting the curvature of the distal end of the heart valve delivery system. In this embodiment, the circumferential positioning structure may include a tubular housing 2, an anti-inner tube rotation tube 213 and an anti-outer tube rotation tube 215 disposed within the tubular housing. The tubular housing 2 is configured to drive the catheter system to rotate circumferentially synchronously with the tubular housing 2 when the tubular housing 2 rotates circumferentially. In this embodiment, the axial positioning structure may include an external thread sleeve 3 and a tubular guide member 4, and the external thread sleeve 3 and the tubular guide member 4 are connected by a driving nut 8. By rotating the driving nut 8, the external thread sleeve 3 can axially move relative to the tubular guide member 4.

[0065] Compared with the prior art, the improvement of the present application lies first in the connection manner between the tubular housing 2 and the external thread sleeve 3. Specifically, the proximal end of the circumferential positioning structure and the distal end of the external thread sleeve of the axial positioning structure are connected by a detachable first pin. In a specific embodiment, referring to Figure 5 , the proximal end of the tubular housing 2 may include externally inserted pin holes 201 circumferentially spaced apart. The distal end of the external thread sleeve 3 may include internally inserted pin holes 301 circumferentially spaced apart. When the distal end of the external thread sleeve 3 is sleeved within the proximal end of the tubular housing 2, the externally inserted pin holes 201 and the internally inserted pin holes 301 are aligned only at specific positions to form a through hole suitable for inserting the pin 20. In a specific embodiment, the number of the externally inserted pin holes 201 and the internally inserted pin holes 301 is different. In a specific embodiment, the external thread sleeve 3 may further include a protrusion 303 disposed at the bottom of the internally inserted pin hole and cooperating with the first pin to prevent the first pin 20 from falling off by itself.

[0066] In a specific embodiment, a scale 202 is included on the outer surface of the proximal end of the tubular housing, and the scale 202 is disposed beside the externally inserted pin hole 201 and corresponds to the externally inserted pin hole 201. In a specific embodiment, the scale 202 may be an angle display, a rotation degree, a rotation arrow, or from a small angle to a large angle, etc.

[0067] Those skilled in the art can understand that in another embodiment, the proximal end of the tubular housing 2 may include circumferentially spaced inner pin holes, and the distal end of the external thread sleeve 3 may include circumferentially spaced outer pin holes 201. When the proximal end of the tubular housing 2 is sleeved within the distal end of the external thread sleeve 3, the outer pin holes and the inner pin holes are aligned at a specific position, forming a through hole suitable for inserting a pin in this case. Similarly, scales corresponding to the outer pin holes may be provided on the outer surface of the distal end of the external thread sleeve 3 near the outer pin holes. In a specific embodiment, the scale 202 may be an angle display, a rotation degree, a rotation arrow, or from a small angle to a large angle, etc.

[0068] Those skilled in the art can understand that when the pin 20 is removed, circumferential rotation of the external thread sleeve 3 relative to the tubular housing 2 is allowed. When the pin 20 is inserted, circumferential rotation of the external thread sleeve 3 relative to the tubular housing 2 is not allowed.

[0069] Next, each part of the heart valve delivery system 100 and their positional relationships will be described in more detail with reference to the accompanying drawings.

[0070] Next, the structure of the release end 1 and the positional relationship between the release end 1 and the tubular housing 2 will be described.

[0071] The release end 1 is used to release the proximal end of the heart valve by pushing the inner tube forward. In one embodiment, referring to Figure 6 and Figure 7 , the release end 1 includes a hollow central shaft 101 and a plurality of release discs 102 spaced around the hollow central shaft. The central shaft includes a first hollow channel 103 and a second hollow channel 104 suitable for a guide wire to pass through. The diameter of the first hollow channel 103 is smaller than that of the second hollow channel 104, and the first hollow channel 103 is closer to the distal end of the release device than the second hollow channel 104. The inner tube is fixedly connected within the second hollow channel 104. In a specific embodiment, since the diameter of the guide wire is smaller than that of the inner tube, the diameter of the first hollow channel 103 is smaller than that of the second hollow channel 104. In a specific embodiment, the inner tube can be snap-fitted in the second hollow channel 104, then sequentially pass through the tubular housing 2, the external thread sleeve 3, and the tubular guide 4, and extend towards the proximal end of the heart valve delivery system. In a specific embodiment, along the direction from the distal end to the proximal end, the diameters of the plurality of release discs 102 may first decrease and then increase, thereby increasing the friction and facilitating grasping.

[0072] The distal end of the release end 1 can be connected to the proximal end of the tubular housing 2. In a specific embodiment, the proximal end of the release end 1 is sleeved within the distal end of the tubular housing 2, and the maximum radial dimension of the proximal end of the release end 1 is greater than the maximum dimension of the opening at the distal end of the tubular housing, for limiting the maximum axial movement distance of the release end 1 in the direction of the distal end. This setting can prevent the release end 1 from detaching from the tubular housing 2.

[0073] In another embodiment, an engaging member 6 is provided between the release end 1 and the tubular housing 2, for filling the gap between the release end 1 and the tubular housing 2 and preventing the release end 1 from pushing the inner tube in the direction of the proximal end. When it is necessary to release the proximal end of the heart valve, the engaging member is removed, and the release end 1 is pushed in the direction of the proximal end, and the inner tube also moves in the direction of the proximal end accordingly. When the inner tube is separated from the middle tube, the proximal end of the heart valve can be inflated.

[0074] Next, the structure of the tubular housing 2 and the positional relationship between the tubular housing 2 and the external thread sleeve 3 will be described.

[0075] In one embodiment, referring to Figures 7 - 11 , the circumferential positioning structure of the heart valve delivery system 100 may include a tubular housing 2, an anti-middle tube rotation tube 213, and an anti-external tube rotation tube 215. The tubular housing 2 may include a housing outer surface 21, a housing inner surface 22, and a housing wall 23 extending between the housing outer surface 21 and the housing inner surface 22. At least a part of the catheter system passes through the hollow interior of the tubular housing 2. One end of the anti-middle tube rotation tube 213 is in fluid communication with the internal space of the first stepped sealing sleeve 25, and the other end abuts against the tubular housing 2 and extends through the housing inner surface 22 of the tubular housing. The anti-middle tube rotation tube 213 also serves as an evacuation tube for the middle tube, for discharging the air between the middle tube and the inner tube. One end of the anti-external tube rotation tube 215 is in fluid-tightly communicated with the internal space of the second stepped sealing sleeve 26, and the other end abuts against the tubular housing 2 and extends through the housing inner surface 22 of the tubular housing. The anti-external tube rotation tube 215 also serves as an evacuation tube for the external tube, for discharging the air between the external tube and the middle tube. The internal space of the first stepped sealing sleeve 25, the outer surface of the inner tube, and the inner surface of the middle tube form a first cavity having an opening at the proximal end of the middle tube. The air between the middle tube and the inner tube can be discharged by injecting physiological saline into the first cavity. Similarly, the internal space of the second stepped sealing sleeve 26, the outer surface of the middle tube, and the inner surface of the external tube form a second cavity having an opening at the proximal end of the external tube. The air between the external tube and the middle tube can be discharged by injecting physiological saline into the second cavity. In one embodiment, the first stepped sealing sleeve 25 and the second stepped sealing sleeve 26 are disposed inside the tubular housing 2 along the direction from the distal end to the proximal end.

[0076] In a specific embodiment, the first stepped sealing sleeve 25 includes a first sleeve 251 and a second sleeve 252 fixedly connected thereto. The first sleeve 251 is closer to the distal end of the tubular housing 2 than the second sleeve 252. In one embodiment, the diameter of the second sleeve 252 is smaller than that of the first sleeve 251, and the distal end of the middle tube is fixedly connected to the hollow inner space of the second sleeve 252. For example, the distal end of the middle tube can be snap-fitted into the hollow inner space of the second sleeve. In one embodiment, the distal end of the first sleeve 251 includes a sealing structure.

[0077] In a specific embodiment, the second stepped sealing sleeve includes a third sleeve 261, a fourth sleeve 262, and a fifth sleeve 263 fixedly connected thereto. The fourth sleeve 262 is closer to the distal end of the tubular housing 2 than the third sleeve 261, and the fifth sleeve 263 is closer to the distal end of the tubular housing 2 than the fourth sleeve 262. The diameter of the fourth sleeve 262 is smaller than that of the third sleeve 261, and the diameter of the fifth sleeve 263 is smaller than that of the fourth sleeve 262. The distal end of the outer tube is fixedly connected to the hollow inner space of the fifth sleeve 263. For example, the distal end of the outer tube can be snap-fitted into the hollow inner space of the fifth sleeve. In one embodiment, the distal end of the third sleeve 261 includes a sealing structure.

[0078] In this embodiment, the middle tube is fixedly connected to the inner space of the second sleeve 252, and one end of the middle tube anti-rotation tube 213 is fixedly connected to the first sleeve 251, and the other end is stuck in the housing wall of the tubular housing 2. Therefore, the middle tube will rotate circumferentially synchronously with the tubular housing 2. Similarly, the outer tube is fixedly connected to the inner space of the fifth sleeve 263, and one end of the outer tube anti-rotation tube 215 is fixedly connected to the third sleeve 261, and the other end is stuck in the housing wall of the tubular housing 2. Therefore, the outer tube will rotate circumferentially synchronously with the tubular housing 2.

[0079] In one embodiment, the sealing structures at the distal ends of the first sleeve 251 and the third sleeve 261 are similar. The following will refer to Figure 7 、 10 and Figure 11 to describe the sealing structure at the distal end of the third sleeve 261. Generally speaking, a sealing gasket is squeezed between two snap-fit sleeves for sealing, and a stepped hole is provided in the outer sleeve. A perforation is provided in the middle of the sealing gasket. It has a structure with a thick edge and a thin middle, meeting both sealing performance and easy penetrability.

[0080] Refer to Figure 7 and Figure 10, the distal end of the first sleeve 251 may include first snap holes 253 arranged at circumferential intervals and a first stepped hole 254 provided inside thereof. The proximal end of the first sealing sleeve 255 includes a first sealing protrusion 256 capable of cooperating with the first snap holes 253. When the proximal end of the first sealing sleeve 255 is sleeved inside the distal end of the first sleeve 251, the first sealing protrusion 256 snaps into the first snap holes 253, and at the same time, the first sealing gasket 257 is squeezed into the stepped hole 254 of the first sleeve 251 to achieve the sealing of the inner tube.

[0081] Similarly, referring to Figure 7 , Figure 10 and Figure 11 , the distal end of the third sleeve 261 may include second snap holes 264 arranged at circumferential intervals and a second stepped hole 265 provided inside thereof. The proximal end of the second sealing sleeve 266 includes a second sealing protrusion 267 capable of cooperating with the second snap holes 264. When the proximal end of the second sealing sleeve 266 is sleeved inside the distal end of the third sleeve 261, the second sealing protrusion 267 snaps into the second snap holes 264, and at the same time, the second sealing gasket 268 is squeezed into the second stepped hole 265 of the third sleeve 261 to achieve the sealing of the outer tube.

[0082] In a preferred embodiment, the first stepped hole 254 and the second stepped hole 265 are provided with chamfers, which cooperate with the thicker outer periphery of the gasket to enhance the sealing effect.

[0083] In one embodiment, referring to Figures 6 - 10 and Figure 16, the inner part of the tubular housing 2 is also provided with the remote center end release structure of the release device, which includes a release plate 7, a driven ring 211, a radial limiting structure, and a driving ring 205. The release plate 7 may have a structure similar to a butterfly. Both ends of the release plate 7 may extend through the tubular housing 2, and the ends thereof may include protruding structures 210 arranged at intervals, which have an anti-slip effect. The center of the release plate 7 is smoothly connected to the driven ring 211, and both ends extend through the tubular housing 2. The driven ring 211 is arranged on the outer periphery of the driving ring 205, includes a groove for accommodating the driving ring 205, and drives the release plate 7 to move axially under the drive of the driving ring 205. In one embodiment, the radial limiting structure includes a plurality of guide rods 212 arranged parallel to the axis of the tubular housing, so that the driven ring 211 can only rotate or move along the axial direction of the tubular housing, but cannot move along the radial direction. In a specific embodiment, the radial limiting structure may include three guide rods 212 with an arc-shaped end point, and the arc can cooperate with the outer contour of the driven ring 211. In one embodiment, the driving ring 205 is wound around the outer periphery of the cylindrical outer tube connection part and cooperates with the driven ring 211 to drive the tubular housing to move along the axial direction of the tubular housing. In a specific embodiment, the driving ring is arranged near the proximal end of the fourth sleeve 262. In one embodiment, the release plate and the driving ring are not in direct axial contact and can rotate freely in the circumferential direction respectively, preventing the valve at the distal end from rotating when the release plate rotates.

[0084] In one embodiment, the tubular housing 2 may include a release plate anti-misoperation structure, which includes a transverse through hole 221 and a longitudinal through hole 222 that communicate with each other. The longitudinal through hole 222 is a rectangular structure, and the width is slightly larger than the thickness of the release plate 7. For example, the width of the longitudinal through hole 222: the thickness of the release plate 7 = 1.1 - 1.3. The release plate 7 can move along the length direction of the longitudinal through hole 222, playing a role in guiding the release plate 7. The transverse through hole extends a first distance along the axis of the rotation axis, and the longitudinal through hole extends a second distance along the axis of the rotation axis. The first distance is configured to limit the axial movement of the release plate along the rotation axis, and the second distance is configured to be suitable for the release plate to move along the axial direction of the rotation axis, and the first distance is less than the second distance. In one embodiment, the tubular housing 2 may further include a raised point 217, which is arranged in the transverse through hole 221 and is used to limit the free movement of the release plate. In order to avoid misoperation of the release plate 7 during the operation, a stepped hole is provided on the tubular housing. When not released, the release plate is located at the lower part of the stepped hole, that is, in the transverse through hole 221, and the release plate is restricted from axial movement.

[0085] Next, the structure of the tubular guide 4 will be described.

[0086] The external thread sleeve 3 can be connected to the tubular guide 4 through the driving nut 8 to jointly form an axial positioning structure for adjusting the axial position of the heart valve.

[0087] Reference Figure 4 , the outer periphery of the external thread sleeve 3 includes an external thread 302 for cooperating with the driving nut 8. At this time, the distal end of the external thread sleeve 3 may further include a guide groove 304 recessed towards the inside of the external thread sleeve 3, so that the external thread sleeve 3 axially moves non-rotationally along the tubular guide 4. The external thread sleeve 3 further includes an external thread sleeve hollow channel 305 for accommodating guide wires and catheters.

[0088] Reference Figures 12 - 14 , for convenient assembly, the driving nut 8 can be used in cooperation with the snap ring 81 and the connecting ring 82. The driving nut 8 may include a driving nut assembly hole 801 provided on the proximal end face of the driving nut 8 and a driving nut stepped hole 802 recessed a predetermined distance from the proximal end face of the driving nut 8 towards the distal end of the driving nut 8. Correspondingly, the snap ring 81 includes a snap ring assembly hole 811 provided on the distal end face of the snap ring 81 and a snap ring stepped hole 812 recessed a predetermined distance from the distal end face of the snap ring 81 towards the proximal end of the snap ring. The driving nut assembly hole 801 and the snap ring assembly hole 811 correspond to each other for fixing the driving nut 8 and the snap ring 81. The connecting ring 82 can be provided at the distal end of the tubular guide 4 and is adapted to be accommodated in the cavity formed by the driving nut stepped hole 802 and the snap ring stepped hole 812.

[0089] The proximal end of the tubular guide 4 can be connected to the conical guide structure 10 through the connecting nut 9. Reference Figure 15 and 16 , the proximal end of the tubular guide 4 can be provided with an external thread 405 for cooperating with the internal thread of the connecting nut 9. In addition, an annular connecting disc 406 can be provided between the proximal end of the tubular guide 4 and the distal end of the conical guide structure 10. A first snap ring 407 and a second snap ring 408 can be provided on the side of the annular connecting disc 406 facing the conical guide structure 10, and the diameter of the second snap ring 408 is greater than that of the first snap ring 407. Such a structure makes the contact part between the annular connecting disc 406 and the conical guide structure 10 gradually shorter in the radial direction from the middle, and the structure is more stable. The annular connecting disc further includes a connecting rivet 409 and a wire-drawing hole 410 suitable for a wire to pass through. In a specific embodiment, as Figure 20 shown, the conical guide structure 10 further includes a wire-drawing channel 1006 suitable for a wire to pass through. Reference Figure 21, the included angle α between the wire-drawing channel 1006 and the central axis of the conical guiding structure 10 is not greater than 30° (not shown in the figure). The conical guiding structure 10 may include an inserting tube 1001 and a conical outer shell 1002. The inserting tube may extend through the central opening of the annular connecting plate, and the end of the inserting tube may include a concave platform 1003 recessed towards the proximal end of the inserting tube for cooperating with the sealing ring. In addition, referring to Figure 15 , at least three stepped baffles 1004 may be arranged inside the conical outer shell and on the outer periphery of the inserting tube.

[0090] The stepped baffle 1004 extends along the axial direction of the inserting tube, and the end of each baffle towards the distal end of the inserting tube includes a first groove 1007 and a second groove 1008 recessed towards the proximal end of the inserting tube. The first groove 1007 is closer to the inserting tube and is used for cooperating with the first snap ring 407. The second groove 1008 is closer to the conical outer shell 1002 and is used for cooperating with the second snap ring 408 to achieve double sealing. The distal end of the conical guiding structure 10 may further include a mounting hole 1005 for cooperating with the connecting rivet 409.

[0091] Next, the structure of the bending adjustment device 5 and the positional relationship between the bending adjustment device 5 and the tubular guide 4 will be briefly described.

[0092] Referring to Figures 13 - 15 , the heart valve delivery system 100 may further include a bending adjustment device 5. The bending adjustment device 5 includes a hollow channel of the bending adjustment device adapted to accommodate the adjustable bending tube. The bending degree of the adjustable bending tube is adjustable. For example, it can be adjusted by setting a rotating handle and a wire on the bending adjustment device 5. The distal end of the bending adjustment device 5 is connected to the tubular guide 4, and the hollow channel of the bending adjustment device is communicated with the hollow channel inside the tubular guide 4 to form a hollow channel adapted to accommodate the adjustable bending tube.

[0093] It should be noted that any bending adjustment structure can be applied to the heart valve delivery system described herein. However, in one embodiment, the bending adjustment device 5 is as Figures 16 - 20As shown. The bending device 5 may include a housing 51, a rotating handle 52, a guide member 53, a threaded tube 54, and a double-sided threaded sleeve 55. The housing 51 of the bending device 5 may be fixedly connected to the outer surface of the tubular guide member 4. The rotating handle 52 may be sleeved within the distal opening of the housing 51 for adjusting the circumferential movement of the guide member 53, the threaded tube 54, and the bending tube 70. The double-sided threaded sleeve 55 is sleeved on the outer periphery of the threaded tube 54 and is connected to the housing 51 with internal threads through a threaded structure. The guide member 53 is relatively fixed to the housing 51, and a limiting ring 531, a first guide rail 532, and a wire fixing end 533 are provided on the outer periphery of the guide member 53. The wire fixing end 533 can axially move along the first guide rail 532. The wire fixing end may include a through hole for fixing the wire and a wire hole 56 suitable for the wire to pass through. The limiting ring defines the farthest point where the wire fixing end can move.

[0094] At the distal end of the wire fixing end 533 of the threaded tube 54, for the convenience of assembly, the two are independent individuals. The wire is in a tensioned state throughout the process. When moving proximally, the threaded tube 54 drives the wire fixing end to move, and at this time, the tension of the wire gradually increases until it reaches the limiting ring. When moving distally, since the threaded tube moves distally, the resistance to the wire fixing end is removed, and the wire fixing end moves distally with the threaded tube under the action of the restoring force. Notches are provided at both the left and right ends of the threaded tube for the convenience of wire passing and reducing the restriction of the two sides of the threaded tube on the wire.

[0095] The bending device 5 further includes an anti-axial movement member 57 provided at the distal end of the threaded tube 54, which is engaged with the housing 51 to prevent the guide member 53 from axially moving. The bending device 5 may further include an anti-rotation member 58 provided at the distal end of the anti-axial movement member 57, which can be engaged with the housing 51 to prevent the guide member 53 from circumferentially moving.

[0096] Next, the structure of the proximal end of the catheter system, the heart valve delivery system, and the positional relationship between the structure of the proximal end of the heart valve delivery system and the heart valve will be described.

[0097] In one embodiment, referring to FIGS. 16-21, an everted structure 401 is provided at the distal end of the inner tube 40 to form a ring, and a first outward expansion structure 502 is provided at the distal end of the middle tube 50. The proximal end of the heart valve is clamped between the ring and the outward expansion structure. In a preferred embodiment, a second outward expansion structure 601 is provided at the distal end of the outer tube 60. The connection between the middle tube and the second outward expansion structure includes a fixing ring, and the proximal end of the heart valve is clamped between the second outward expansion structure and the fixing ring to limit its radial movement. In a preferred embodiment, at least one constriction groove communicating with the outside is provided axially on the fixing ring and is clamped with the distal end of the heart valve to limit the axial movement of the heart valve.

[0098] The outer tube 60 can extend through the end of the adjustable bend tube and is sleeved on the outer periphery of the middle tube through a snap ring. The inner tube 40 is sleeved on the outer periphery of the middle tube 50, and a guide wire hole 41 is included at the end of the inner tube. When using this delivery device to deliver an aortic valve, the distal end of the valve is clamped between the middle tube and the outer tube, and the proximal end is clamped between the inner tube and the middle tube. In actual operation, an introducer is also sleeved outside the valve, and the valve is further constricted in the introducer tube of the introducer (the structure of the introducer is not shown in this document).

[0099] In a preferred embodiment, as Figure 3 shown, a valve fixing ring 501 is provided at the distal end of the middle tube for clamping with the distal end of the valve.

[0100] In addition, as an example, Figure 22 a heart valve 2000 is shown. The heart valve 2000 may include a connection block 2001 for connecting to the catheter system described herein. The distal end 2002 of the heart valve 2000 may include a diamond grid. The artificial heart valve 2100 may be sutured to the heart valve 2000.

[0101] Example 2

[0102] This embodiment provides a method for delivering a heart valve using a heart valve delivery system, which includes the following steps:

[0103] S1: Make a small hole at the left femoral artery, insert a guide wire through the small hole, through the femoral artery, ascending aorta, across the aortic arch, and after entering the descending aorta, reach the outside of the descending aorta. The dilator and the outer sheath tube together enter the aorta along the guide wire, withdraw the dilator, and the outer sheath tube forms a passage for the delivery system to enter and exit;

[0104] S2: Pre-load the heart valve in the delivery system using an introducer, reach the preliminary set position through the outer sheath tube,

[0105] withdraw the introducer, and release the positioner of the heart valve;

[0106] Rotate the bending adjustment device 5 to adjust the heart valve to the central axis of the aorta;

[0107] Pull out the first pin 20, separate the external thread sleeve 3 and the tubular housing 2, rotate the tubular housing 2, drive the circumferential rotation of the distal heart valve, so that the positioner of the heart valve is axially aligned with the sinus bottom of the aortic valve leaflet, and insert the pin;

[0108] Rotate the drive nut 8 to drive the rear tubular guide 4 to move distally, and steadily deliver the positioner of the heart valve to the sinus bottom position of the aortic valve;

[0109] Release the heart valve, pull out the engaging part 6, push the release end 1 distally to drive the inner tube 40 to move distally, release the proximal end of the heart valve, and the bottom abuts against the aortic annulus. The outer wall of the heart valve and the locator clamp the aortic valve leaflets together;

[0110] Rotate the release plate 7, pull the release plate proximally to drive the outer tube 60 to move proximally, release the distal end of the heart valve, and it automatically expands to a predetermined size, and the middle tube 50 is released;

[0111] After confirming that the heart valve is clamped properly, pull the delivery system proximally to withdraw it from the body, and complete the implantation of the aortic valve.

[0112] For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and without departing from the spirit or basic characteristics of the present invention, the present invention can be implemented in other specific forms. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present invention. Any reference signs in the claims should not be regarded as limiting the claims involved.

Claims

1. A heart valve delivery system, characterized in that, Comprising: A catheter system for delivering an external heart valve to a target position, the catheter system including an inner tube, a middle tube, and an outer tube sleeved in sequence. The proximal end of the heart valve is configured to be clamped between the inner tube and the middle tube, and the distal end of the heart valve is configured to be clamped between the middle tube and the outer tube; A release device for releasing the heart valve, the release device including a proximal end release structure and a distal end release structure. The proximal end release structure is used to control the axial movement of the outer tube, and the distal end release structure is used to control the axial movement of the inner tube; A positioning device for precisely positioning the heart valve, the positioning device including a central positioning structure, a circumferential positioning structure, and an axial positioning structure. The central positioning structure moves the heart valve to the central axis of the aorta by adjusting the curvature of the distal end of the heart valve delivery system. The circumferential positioning structure is fixedly connected to the catheter system and is configured to drive the catheter system to rotate around its axis so that the positioning member of the heart valve is axially aligned with the sinus bottom. The axial positioning structure is used to adjust the axial position of the heart valve, including an external thread sleeve and a tubular guide member, and the external thread sleeve is configured to be axially movable relative to the tubular guide member but not circumferentially movable; Wherein, the proximal end of the external thread sleeve and the distal end of the tubular guide member are connected by a driving nut, and the driving nut is used to control the axial movement of the external thread sleeve relative to the tubular guide member; Wherein, the proximal end of the circumferential positioning structure and the distal end of the external thread sleeve of the axial positioning structure are detachably connected; Wherein, the circumferential positioning structure includes: A tubular housing, the tubular housing including a housing outer surface, a housing inner surface, and a housing wall extending between the housing outer surface and the housing inner surface, wherein at least a part of the catheter system passes through the hollow interior of the tubular housing; An anti-middle tube rotation tube, one end of the anti-middle tube rotation tube is in fluid communication with the internal space of the first stepped sealing sleeve, the other end abuts against the tubular housing and extends through the housing inner surface of the tubular housing. The anti-middle tube rotation tube also serves as an exhaust tube for the middle tube to discharge the air between the middle tube and the inner tube; An anti-outer tube rotation tube, one end of the anti-outer tube rotation tube is in fluid communication with the internal space of the second stepped sealing sleeve, the other end abuts against the tubular housing and extends through the housing inner surface of the tubular housing. The anti-outer tube rotation tube also serves as an exhaust tube for the outer tube to discharge the air between the outer tube and the middle tube; Wherein, the internal space of the first stepped sealing sleeve, the outer surface of the inner tube, and the inner surface of the middle tube form a first cavity having an opening at the proximal end of the middle tube. The internal space of the second stepped sealing sleeve, the outer surface of the middle tube, and the inner surface of the outer tube form a second cavity having an opening at the proximal end of the outer tube, and the first stepped sealing sleeve and the second stepped sealing sleeve are arranged inside the tubular housing along the direction from the distal end to the proximal end; Wherein, the tubular housing is configured such that when the tubular housing rotates circumferentially, the catheter system rotates circumferentially synchronously with the tubular housing.

2. The heart valve delivery system according to claim 1, wherein The proximal end of the circumferential positioning structure and the distal end of the outer threaded sleeve of the axial positioning structure are connected by a detachable first pin.

3. The heart valve delivery system according to claim 1, wherein, The first stepped sealing sleeve includes a first sleeve and a second sleeve fixedly connected. The first sleeve is closer to the distal end of the tubular housing than the second sleeve, and the distal end of the first sleeve includes a sealing structure. The diameter of the second sleeve is smaller than that of the first sleeve, and the distal end of the middle tube is fixedly connected to the hollow inner space of the second sleeve.

4. The heart valve delivery system according to claim 1, wherein, The second stepped sealing sleeve includes a third sleeve, a fourth sleeve, and a fifth sleeve fixedly connected. The fourth sleeve is closer to the distal end of the tubular housing than the third sleeve, and the fifth sleeve is closer to the distal end of the tubular housing than the fourth sleeve. The distal end of the third sleeve includes a sealing structure. The diameter of the fourth sleeve is smaller than that of the third sleeve, the diameter of the fifth sleeve is smaller than that of the fourth sleeve, and the distal end of the outer tube is fixedly connected to the hollow inner space of the fifth sleeve.

5. The heart valve delivery system according to any one of claims 1-4, characterized in that, The proximal end of the tubular housing includes circumferentially spaced first pin holes, and the distal end of the outer threaded sleeve includes second pin holes that cooperate with the first pin holes. The first pin holes and the second pin holes are configured to coincide only at specific positions to form through holes suitable for accommodating the pins. Wherein, the first pin holes are outer pin holes and the second pin holes are inner pin holes, or the first pin holes are inner pin holes and the second pin holes are outer pin holes.

6. The heart valve delivery system according to claim 5, characterized in that, The number of the first pin holes and the second pin holes is different.

7. The heart valve delivery system according to claim 5, characterized in that, The first pin holes are outer pin holes, and scales are provided beside the outer pin holes and correspond to the outer pin holes.

8. The heart valve delivery system according to any one of claims 1-4, characterized in that, The distal end release structure of the release device includes a release plate, a driven ring, and a driving ring. The driven ring is arranged around the driving ring and is used to drive the release plate to move axially under the drive of the driving ring. The release plate is in a butterfly shape, and both ends of the release plate extend through the tubular housing and are smoothly connected to the driven ring at the center. The driving ring is arranged around the outer circumference of the cylindrical outer tube connection part and cooperates with the driven ring to drive the tubular housing to move along the axial direction of the tubular housing.

9. The heart valve delivery system according to claim 8, wherein The release device is also provided with a radial limiting structure, which includes a plurality of guide rods arranged parallel to the axial direction of the tubular housing, so that the driven ring cannot move radially.

10. The heart valve delivery system according to claim 8, wherein The tubular housing includes a release plate anti-misoperation structure, which includes a transverse through hole and a longitudinal through hole that communicate with each other on the tubular housing. The transverse through hole extends axially along the rotation axis for a first distance, and the longitudinal through hole extends axially along the rotation axis for a second distance. The first distance is configured to limit the axial movement of the release plate along the rotation axis, and the second distance is configured to be suitable for the axial movement of the release plate along the rotation axis, and the first distance is less than the second distance.

11. The heart valve delivery system according to any one of claims 1-4, characterized in that, The proximal release structure of the release device includes a hollow central shaft and a plurality of release discs spaced around the hollow central shaft. The central shaft includes a first hollow channel and a second hollow channel adapted for a guide wire to pass through. The diameter of the first hollow channel is smaller than that of the second hollow channel. The first hollow channel is closer to the distal end of the release device than the second hollow channel, and the inner tube is fixedly connected within the second hollow channel.

12. The heart valve delivery system according to claim 11, wherein The proximal end of the proximal release structure is sleeved within the distal end of the tubular housing, and the maximum radial dimension of the proximal end of the proximal release structure is greater than the maximum dimension of the distal opening of the tubular housing, for limiting the maximum axial movement distance of the proximal release structure in the distal direction.

13. The heart valve delivery system according to claim 11, wherein A detachable engaging member is provided between the proximal end sleeve of the proximal release structure and the distal end of the tubular housing, for limiting the axial movement of the proximal release structure.

14. The heart valve delivery system according to any one of claims 1-4, characterized in that, The distal end of the inner tube is provided with an outwardly folded structure to form a ring, and the distal end of the middle tube is provided with a first outwardly expanding structure. The proximal end of the heart valve is clamped between the ring and the outwardly expanding structure.

15. The heart valve delivery system according to claim 14, wherein, The distal end of the outer tube is provided with a second outwardly expanding structure. The connection between the middle tube and the second outwardly expanding structure includes a fixing ring. The proximal end of the heart valve is clamped between the second outwardly expanding structure and the fixing ring to limit its radial movement.

16. The heart valve delivery system according to claim 15, characterized in that, The fixing ring is provided with at least one constriction groove communicating with the outside along the axis, which is clamped with the distal end of the heart valve to limit the axial movement of the heart valve.

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