Bidirectionally released heart valve delivery system

Abstract

This application discloses a bidirectionally movable and releaseable heart valve delivery system, comprising a catheter system for delivering an external heart valve to a target location. The catheter system comprises an inner tube, a middle tube, and an outer tube that are sequentially connected. The proximal end of the heart valve is configured to be snapped between the inner and middle tubes, and the distal end of the heart valve is configured to be snapped between the middle and outer tubes. The heart valve delivery system described herein can securely secure the heart valve and release the heart valve through bidirectional movement, thereby avoiding damage to human tissue.

Description

Technical Field

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

[0002] Due to the advantages of transcatheter surgery, such as minimal trauma and rapid recovery, more and more surgeries are being performed using transcatheter surgery. Aortic valve replacement has also evolved from an early surgical procedure to a transcatheter approach.

[0003] Aortic valve replacement typically requires the use of a heart valve and a heart valve delivery system. With the emergence of new heart valves, higher requirements are being placed on these systems. Specifically, the heart valve delivery system must ensure the accurate placement and angle of the heart valve into the aorta, providing adequate space for expansion while also ensuring that no tissue is lost during delivery.

[0004] Therefore, there is a continuous need in the art to develop a heart valve delivery system that is precise in positioning and easy to operate. Summary of the Invention

[0005] The present application aims to provide a heart valve delivery system that is precisely positioned and easy to operate. The heart valve delivery system described herein may include a catheter system for delivering an external heart valve to a target location, a release device for releasing the heart valve, and a positioning device for precisely positioning the heart valve. The positioning device may include a central positioning structure, a circumferential positioning structure, and an axial positioning structure, wherein the proximal end of the circumferential positioning structure and the distal end of the externally threaded sleeve of the axial positioning structure are connected by a removable first latch. Specifically, the proximal end of the circumferential positioning structure may include a latch hole, and the distal end of the axial positioning structure may include a second latch hole that cooperates with the latch hole. The latch hole and the second latch hole are aligned only at specific positions to form a through hole suitable for accommodating the latch. 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 latch 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 objectives, the present invention provides the following technical solutions.

[0007] In a first aspect, the present application provides a bidirectionally movable and released heart valve delivery system, characterized by comprising:

[0008] A catheter system is used to deliver an external heart valve to a target location. The catheter system includes an inner tube, a middle tube, and an outer tube that are sequentially connected. 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.

[0009] In one embodiment of the first aspect, the distal end of the inner tube is provided with an outward folding structure to form a circular ring, the distal end of the middle tube is provided with a first outward expansion structure, and the proximal end of the heart valve is clamped between the circular ring and the outward expansion structure.

[0010] In one embodiment of the first aspect, the distal end of the outer tube is provided with a second outward expansion structure, 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 connected between the second outward expansion structure and the fixing ring to limit its radial movement.

[0011] In one embodiment of the first aspect, the fixing ring is provided with at least one shrinkage groove in axial direction and communicated with the outside, which is engaged with the distal end of the heart valve to limit the axial movement of the heart valve.

[0012] In one embodiment of the first aspect, the necking groove includes a first opening and a second opening that are connected, wherein the second opening is closer to the proximal end of the heart valve than the first opening, and the circumferential size of the second opening is smaller than the circumferential size of the first opening.

[0013] In one embodiment of the first aspect, the bidirectionally movable and released heart valve delivery system also includes a catheter system guide structure, which includes a tubular guide member and a conical guide structure connected to each other, the proximal end of the tubular guide member is connected to the distal end of the conical guide structure, and the inner tube, middle tube and outer tube in the catheter system all pass through the tubular guide member and extend a predetermined distance through the proximal end of the conical guide structure.

[0014] In one embodiment of the first aspect, the proximal end of the tubular guide member is connected to the distal end of the conical guide structure via a connecting nut, and the proximal end of the tubular guide member is provided with an external thread that cooperates with the internal thread of the connecting nut.

[0015] In one embodiment of the first aspect, an annular connecting disk may be provided between the proximal end of the tubular guide and the distal end of the tapered guide structure. In this embodiment, the tapered guide structure comprises an insertion tube and a tapered housing, wherein the insertion tube extends through a central opening of the annular connecting disk.

[0016] In one embodiment of the first aspect, the annular connecting disk includes a wire hole suitable for the wire to pass through, and the tapered guide structure includes a wire channel suitable for the wire to pass through.

[0017] In one embodiment of the first aspect, an angle α between the wire pulling channel and the central axis of the tapered guide structure is no greater than 30°.

[0018] In one embodiment of the first aspect, a first retaining ring and a second retaining ring are provided on a side of the annular connecting disk facing the conical guide structure, wherein the second retaining ring has a larger diameter than the first retaining ring. In this embodiment, the conical guide structure includes a stepped baffle disposed within the conical housing and on the outer periphery of the insertion tube. The stepped baffle extends axially along the insertion tube, and the end of each baffle facing the distal end of the insertion tube includes a first groove and a second groove recessed toward the proximal end of the insertion tube. The first groove is closer to the insertion tube and is configured to cooperate with the first retaining ring, while the second groove is closer to the conical housing and is configured to cooperate with the second retaining ring to achieve a double seal.

[0019] In one embodiment of the first aspect, the end of the insertion tube may include a recessed platform recessed toward the proximal end of the insertion tube, for cooperating with the sealing ring.

[0020] Compared with the prior art, the present invention has the following advantages:

[0021] (1) When the heart valve delivery system described herein is used 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 withdrawing the outer tube. This can avoid damage to the valve or re-moval of the positioned valve during the process of pushing the valve to the left (left ventricle side) as in competing products.

[0022] (2) The distal end of the middle tube includes a heart valve fixing ring for clamping the heart valve in the fixing ring to prevent the heart valve from losing vascular tissue;

[0023] (3) A unique clamping ring and baffle structure is provided between the tubular guide member and the conical guide structure of the catheter system guide structure, which can achieve double sealing. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] 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:

[0025] Figure 1 A schematic diagram showing a heart valve delivery system according to one embodiment of the present application;

[0026] Figure 2 show Figure 1 A partial enlarged view of point F in the middle;

[0027] Figure 3 show Figure 1A partial enlarged view of point E in the middle;

[0028] Figure 4 show Figure 1 A partial enlarged view of point G in the middle;

[0029] 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;

[0030] Figure 6 A front view of a tubular housing according to one embodiment of the present application is shown;

[0031] Figure 7 show Figure 6 Cross-sectional view of the middle DD section;

[0032] Figure 8 A schematic diagram showing the internal structure of a tubular housing according to an embodiment of the present application;

[0033] 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;

[0034] Figure 10 An exploded view showing a tubular housing according to one embodiment of the present application;

[0035] Figure 11 A schematic diagram showing an outer tube sealing structure according to an embodiment of the present application;

[0036] Figure 12 An exploded view showing a tubular guide according to one embodiment of the present application;

[0037] Figure 13 An exploded view showing a tubular guide member and a tapered guide structure according to one embodiment of the present application;

[0038] Figure 14 An exploded view showing another angle of a tubular guide member and a tapered guide structure according to an embodiment of the present application;

[0039] Figure 15 A schematic diagram showing a tapered guide structure according to an embodiment of the present application;

[0040] Figure 16 A schematic diagram showing the internal structure of a heart valve delivery system according to another embodiment of the present application;

[0041] Figure 17 show Figure 16 A partial enlarged view of point B in the middle;

[0042] Figure 18A schematic structural diagram showing a threaded pipe according to an embodiment of the present application;

[0043] Figure 19 A top view showing a heart valve delivery system according to another embodiment of the present application;

[0044] Figure 20 show Figure 19 Cross-section of the middle AA surface;

[0045] Figure 21 show Figure 20 A partial enlarged view of the middle M part;

[0046] Figure 22 show Figure 19 Schematic diagram of the mid- and distal ends;

[0047] Figure 23 A distal structure of a heart valve delivery system is shown according to one embodiment.

[0048] Figure 24 A schematic diagram shows a heart valve according to one embodiment. DETAILED DESCRIPTION

[0049] Unless otherwise defined, technical or scientific terms used in this specification and claims shall have the same general meaning as understood by persons having ordinary skills in the technical field to which the present invention belongs.

[0050] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as limiting the present invention.

[0051] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the technical features being referred to. Thus, a feature identified with "first," "second," etc., may explicitly or implicitly include one or more of such features. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0052] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to connection, detachable connection, or integral connection; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; or internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0053] As described herein, when describing a heart valve, a release tip, a tubular housing, an internally threaded sleeve, a tubular housing, a tubular guide, a bending adjustment structure, a guidewire, and a catheter system, the "proximal end" refers to the side of the catheter system or the side in the direction of the end manipulated by the user when the heart valve is in an extended state. Accordingly, the "distal end" refers to the side away from the catheter system or the side in the direction away from the end manipulated by the user when the heart valve is in an extended state. In this application, when describing the heart valve, the "proximal end" refers to the side of the heart valve that is close to the apex when the heart valve is in an extended state. Accordingly, the "distal end" refers to the side away from the apex when the heart valve is in an extended state. Because the heart valve described herein is delivered by catheter via the aorta, the distal end and the proximal end refer to the same position, and the proximal end and the distal end refer to the same position.

[0054] Example 1

[0055] This embodiment provides a heart valve delivery system 100 .

[0056] First reference Figure 1-4 , along the direction from the distal end to the proximal end, the heart valve delivery system 100 of this embodiment may include a release terminal 1, a tubular housing 2, an externally threaded sleeve 3, a tubular guide 4 and a tapered guide structure 10 in sequence. The proximal end of the release terminal 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 externally threaded sleeve 3 may be connected by a first pin 20. The proximal end of the externally threaded 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 connecting nut 9. The heart valve delivery system 100 may also include a bending adjustment device 5, the proximal end of which is fixedly connected to the tubular guide 4.

[0057] In addition, the heart valve delivery system 100 may also include a catheter system. This catheter system can be used to deliver an external heart valve to a target location. The catheter system includes an inner tube, a middle tube, and an outer tube that are sequentially connected. The proximal end of the heart valve is configured to be snapped between the inner and middle tubes, and the distal end of the heart valve is configured to be snapped between the middle and outer tubes. The inner, middle, and outer tubes in the catheter system all extend a predetermined distance through the proximal end of the tapered guide structure 10.

[0058] In one embodiment, the heart valve delivery system 100 includes a release device for releasing the heart valve. The release device includes a proximal release structure for controlling the axial movement of the outer tube and a distal release structure for controlling the axial movement of the inner tube. In this embodiment, the proximal release structure may be a release tip 1 for releasing the proximal end of the heart valve. Furthermore, the distal release structure may include a release plate 7 disposed within the tubular housing 2 and protruding from the exterior of the tubular housing 2 for releasing the distal end of the heart valve.

[0059] In one embodiment, a 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 about its axis so that the positioning member of the heart valve is axially aligned with the sinus floor. The axial positioning structure is used to adjust the axial position of the heart valve and includes an externally threaded sleeve and a tubular guide. The externally threaded sleeve is configured to move axially but not circumferentially relative to the tubular guide. In this embodiment, the central positioning structure may include a bending adjustment device 5 for adjusting the curvature of the distal end of the heart valve delivery system to move the heart valve to the central axis of the aorta. In this embodiment, the circumferential positioning structure may include a tubular housing 2, an anti-center tube rotation tube 213 disposed within the tubular housing, and an anti-outer tube rotation tube 215. The tubular housing 2 is configured so that when the tubular housing 2 rotates circumferentially, it drives the catheter system to rotate synchronously with the tubular housing 2. In this embodiment, the axial positioning structure may include an externally threaded sleeve 3 and a tubular guide 4, wherein the externally threaded sleeve 3 and the tubular guide 4 are connected via a drive nut 8. By rotating the drive nut 8, the externally threaded sleeve 3 can be axially moved relative to the tubular guide 4.

[0060] Compared with the prior art, the improvement of the present application lies in the connection method between the tubular housing 2 and the externally threaded sleeve 3. Specifically, the proximal end of the circumferential positioning structure and the distal end of the externally threaded sleeve of the axial positioning structure are connected by a detachable first pin. Figure 5The proximal end of the tubular shell 2 may include outer pin holes 201 spaced circumferentially. The distal end of the externally threaded sleeve 3 may include inner pin holes 301 spaced circumferentially. When the distal end of the externally threaded sleeve 3 is sleeved within the proximal end of the tubular shell 2, the outer pin holes 201 and the inner pin holes 301 are aligned only at specific positions, forming a through hole suitable for inserting the pin 20. In one specific embodiment, the number of the outer pin holes 201 and the number of the inner pin holes 301 are different. In one specific embodiment, the externally threaded sleeve 3 may further include a protrusion 303 disposed at the bottom of the inner pin hole and cooperating with the first pin to prevent the first pin 20 from falling off on its own.

[0061] In one embodiment, the outer surface of the proximal end of the tubular housing includes a scale 202, which is arranged next to and corresponds to the outer pin hole 201. In one embodiment, the scale 202 can be an angle display, a rotation degree, a rotation arrow, or a pointer from a small angle to a large angle, etc.

[0062] Those skilled in the art will appreciate that, in another embodiment, the proximal end of the tubular housing 2 may include inner pin holes spaced circumferentially, while the distal end of the externally threaded sleeve 3 may include outer pin holes 201 spaced circumferentially. When the proximal end of the tubular housing 2 is sleeved within the distal end of the externally threaded 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. Similarly, a scale corresponding to the outer pin hole may be provided on the outer surface of the distal end of the externally threaded sleeve 3 near the outer pin hole. In a specific embodiment, the scale 202 may be an angle display, a rotation degree, a rotation arrow, or a direction from a small angle to a large angle.

[0063] Those skilled in the art will appreciate that when the latch 20 is removed, the externally threaded sleeve 3 is allowed to rotate circumferentially relative to the tubular housing 2. When the latch 20 is inserted, the externally threaded sleeve 3 is not allowed to rotate circumferentially relative to the tubular housing 2.

[0064] The various parts of the heart valve delivery system 100 and the positional relationships therebetween will be described in more detail below with reference to the accompanying drawings.

[0065] Next, the structure of the release tip 1 and the positional relationship between the release tip 1 and the tubular housing 2 will be described.

[0066] The release tip 1 is used to release the proximal end of the heart valve by pushing the inner tube forward. Figure 6 and Figure 7The delivery tip 1 comprises a hollow central shaft 101 and a plurality of release discs 102 spaced apart and sleeved on the hollow central shaft. The central shaft includes a first hollow channel 103 and a second hollow channel 104 for passage of a guidewire. 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 delivery device than the second hollow channel 104. An inner tube is fixedly connected within the second hollow channel 104. In one embodiment, the diameter of the first hollow channel 103 is smaller than that of the second hollow channel 104 because the diameter of the guidewire is smaller than that of the inner tube. In one embodiment, the inner tube can be snapped into the second hollow channel 104, then sequentially passed through the tubular housing 2, the externally threaded sleeve 3, and the tubular guide 4, and extended to the proximal end of the heart valve delivery system. In one embodiment, the diameter of the plurality of release discs 102 can first decrease and then increase from the distal end to the proximal end, thereby increasing friction and facilitating grip.

[0067] The distal end of the release tip 1 can be connected to the proximal end of the tubular housing 2. In one embodiment, the proximal end of the release tip 1 is nested within the distal end of the tubular housing 2, and the maximum radial dimension of the proximal end of the release tip 1 is greater than the maximum dimension of the distal opening of the tubular housing, thereby limiting the maximum axial movement of the release tip 1 toward the distal end. This arrangement prevents the release tip 1 from falling out of the tubular housing 2.

[0068] In another embodiment, a locking member 6 is provided between the release tip 1 and the tubular housing 2 to fill the gap between them and prevent the release tip 1 from pushing the inner tube toward the proximal end. To release the proximal end of the heart valve, the locking member is removed and the release tip 1 is pushed toward the proximal end, causing the inner tube to move in that direction. When the inner tube is separated from the middle tube, the proximal end of the heart valve can expand.

[0069] Next, the structure of the tubular housing 2 and the positional relationship between the tubular housing 2 and the externally threaded sleeve 3 will be described.

[0070] In one embodiment, reference Figure 7-11The circumferential positioning structure of the heart valve delivery system 100 may include a tubular housing 2, an anti-center tube rotation tube 213, and an anti-outer 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 outer and inner surfaces 21 and 22. At least a portion of the catheter system passes through the hollow interior of the tubular housing 2. One end of the anti-center tube rotation tube 213 is in fluid-tight communication with the interior space of the first stepped sealing sleeve 25, while the other end abuts the tubular housing 2 and extends through the inner surface 22 of the tubular housing. The anti-center tube rotation tube 213 also serves as an evacuation tube for the center tube, used to exhaust air between the center tube and the inner tube. One end of the anti-outer tube rotation tube 215 is in fluid-tight communication with the interior space of the second stepped sealing sleeve 26, while the other end abuts the tubular housing 2 and extends through the inner surface 22 of the tubular housing. The outer tube rotation prevention tube 215 is also used as an exhaust tube for the outer tube, for exhausting the air between the outer 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 with an opening at the proximal end of the middle tube. The air between the middle tube and the inner tube can be exhausted 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 outer tube form a second cavity with an opening at the proximal end of the outer tube. The air between the outer tube and the middle tube can be exhausted 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 arranged inside the tubular shell 2 along the direction from the distal end to the proximal end.

[0071] In one embodiment, the first stepped sealing sleeve 25 includes a first sleeve 251 and a second sleeve 252 that are fixedly connected, with the first sleeve 251 being 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 the diameter of the first sleeve 251, and the distal end of the middle tube is fixedly connected to the hollow interior space of the second sleeve 252. For example, the distal end of the middle tube can be snap-fitted into the hollow interior space of the second sleeve. In one embodiment, the distal end of the first sleeve 251 includes a sealing structure.

[0072] In one specific embodiment, the second stepped sealing sleeve includes a third sleeve 261, a fourth sleeve 262, and a fifth sleeve 263 that are fixedly connected. The fourth sleeve 262 is closer to the distal end of the tubular housing than the third sleeve 261, and the fifth sleeve 263 is closer to the distal end of the tubular housing 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 interior space of the fifth sleeve 263. For example, the distal end of the outer tube can be snap-fitted into the hollow interior space of the fifth sleeve. In one embodiment, the distal end of the third sleeve 261 includes a sealing structure.

[0073] In this embodiment, the middle tube is fixedly connected to the interior of the second sleeve 252, while the middle tube rotation prevention tube 213 has one end fixedly connected to the first sleeve 251 and the other end engaged within the wall of the tubular housing 2. Therefore, the middle tube rotates synchronously with the tubular housing 2. Similarly, the outer tube is fixedly connected to the interior of the fifth sleeve 263, while the outer tube rotation prevention tube 215 has one end fixedly connected to the third sleeve 261 and the other end engaged within the wall of the tubular housing 2. Therefore, the outer tube rotates synchronously with the tubular housing 2.

[0074] In one embodiment, the sealing structure of the distal end of the first sleeve 251 is similar to the sealing structure of the distal end of the third sleeve 261. Figure 7 、 10 and Figure 11 The sealing structure at the distal end of the third sleeve 261 is described below. In summary, a sealing gasket is squeezed between two snap-fit sleeves to create a seal. The outer sleeve has a stepped hole. A perforation is located in the center of the sealing gasket. This structure, thick at the edges and thin in the middle, ensures both sealing and easy penetration.

[0075] refer to Figure 7 and Figure 10 The distal end of the first sleeve 251 may include first snap holes 253 spaced circumferentially and a first stepped hole 254 disposed therein. The proximal end of the first sealing sleeve 255 includes a first sealing protrusion 256 that can cooperate with the first snap holes 253. When the proximal end of the first sealing sleeve 255 is inserted into the distal end of the first sleeve 251, the first sealing protrusion 256 snaps into the first snap hole 253, and simultaneously squeezes the first sealing gasket 257 into the stepped hole 254 of the first sleeve 251, thereby sealing the inner tube.

[0076] Similarly, reference Figure 7 、 Figure 10 and Figure 11The distal end of the third sleeve 261 may include second snap holes 264 spaced circumferentially and a second stepped hole 265 disposed therein. The proximal end of the second sealing sleeve 266 includes a second sealing protrusion 267 that can engage with the second snap holes 264. When the proximal end of the second sealing sleeve 266 is sleeved within the distal end of the third sleeve 261, the second sealing protrusion 267 snaps into the second snap hole 265, and simultaneously squeezes the second sealing gasket 268 into the second stepped hole 265 of the third sleeve 261, thereby sealing the outer tube.

[0077] In a preferred embodiment, the first stepped hole 254 and the second stepped hole 265 are provided with chamfers, which cooperate with the thicker periphery of the gasket to enhance the sealing effect.

[0078] In one embodiment, reference Figure 6-10 as well as Figure 16 The tubular housing 2 also houses the distal end release structure of the release device, which includes a release plate 7, a driven ring 211, a radial stopper, and a drive ring 205. The release plate 7 can have a butterfly-like structure, with both ends extending through the tubular housing 2 and including spaced protrusions 210 at its ends to prevent slipping. The center of the release plate 7 is smoothly connected to the driven ring 211, with both ends extending through the tubular housing 2. The driven ring 211 is positioned around the outer periphery of the drive ring 205 and includes a groove for accommodating the drive ring 205. Driven by the drive ring 205, it drives the release plate 7 axially. In one embodiment, the radial stopper includes several guide rods 212 arranged parallel to the axial direction of the tubular housing, ensuring that the driven wheel 211 can only rotate or move along the axial direction of the tubular housing, but not radially. In a specific embodiment, the radial stopper includes three guide rods 212 arranged in an arc shape, with the arc matching the outer contour of the driven ring 211. In one embodiment, the drive ring 205 is disposed around the outer circumference of the cylindrical outer tube connection portion and cooperates with the driven ring 211 to drive the tubular housing to move axially within the tubular housing. In one specific embodiment, the drive ring is positioned proximal to the proximal end of the fourth sleeve 262. In one embodiment, the release plate and the drive ring are not in direct axial contact and are freely rotatable circumferentially, preventing rotation of the distal valve when the release plate rotates.

[0079] In one embodiment, the tubular housing 2 may include a release plate anti-misoperation structure comprising interconnected transverse through-holes 221 and longitudinal through-holes 222. The longitudinal through-holes 222 are rectangular in shape, with a width slightly greater than the thickness of the release plate 7 (e.g., the width of the longitudinal through-hole 222 is equal to the thickness of the release plate 7 = 1.1-1.3). The release plate 7 can move along the length of the longitudinal through-holes 222, serving as a guide for the release plate 7. The transverse through-holes extend a first distance along the axial direction of the rotation axis, and the longitudinal through-holes extend a second distance along the axial direction of the rotation axis. The first distance is configured to limit axial movement of the release plate along the rotation axis, while the second distance is configured to accommodate axial movement of the release plate along the rotation axis, and the first distance is smaller than the second distance. In one embodiment, the tubular housing 2 may further include a protrusion 217 disposed in the transverse through-holes 221 to limit the free movement of the release plate. To prevent misoperation of the release plate 7 during surgery, a stepped hole is provided in the tubular housing. When release is not required, 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.

[0080] Next, the structure of the tubular guide 4 will be described.

[0081] The externally threaded sleeve 3 can be connected to the tubular guide member 4 via a drive nut 8 to form an axial positioning structure for adjusting the axial position of the heart valve.

[0082] refer to Figure 4 The outer circumference of the externally threaded sleeve 3 includes external threads 302 for mating with the drive nut 8. The distal end of the externally threaded sleeve 3 may also include a guide groove 304 recessed toward the interior of the externally threaded sleeve 3, allowing the externally threaded sleeve 3 to move axially along the tubular guide member 4 without rotation. The externally threaded sleeve 3 also includes a hollow channel 305 for accommodating a guidewire and catheter.

[0083] refer to Figure 12-14 To facilitate assembly, the drive nut 8 can be used in conjunction with a snap ring 81 and a connecting ring 82. The drive nut 8 can include a drive nut assembly hole 801 disposed on the proximal end surface of the drive nut 8, and a drive nut stepped hole 802 recessed a predetermined distance from the proximal end surface of the drive nut 8 toward the distal end of the drive nut 8. Correspondingly, the snap ring 81 includes a snap ring assembly hole 811 disposed on the distal end surface of the snap ring 81, and a snap ring stepped hole 812 recessed a predetermined distance from the distal end surface of the snap ring 81 toward the proximal end of the snap ring. The drive nut assembly hole 801 and the snap ring assembly hole 811 correspond to each other and are used to secure the drive nut 8 and the snap ring 81. The connecting ring 82 can be disposed on the distal end of the tubular guide member 4 and is adapted to be accommodated in the cavity formed by the drive nut stepped hole 802 and the snap ring stepped hole 812.

[0084] The proximal end of the tubular guide member 4 can be connected to the conical guide structure 10 via a connecting nut 9. Figure 15 and 16 , the proximal end of the tubular guide member 4 may be provided with an external thread 405 that cooperates with the internal thread of the connecting nut 9. In addition, an annular connecting disk 406 may be provided between the proximal end of the tubular guide member 4 and the distal end of the conical guide structure 10, and a first snap ring 407 and a second snap ring 408 may be provided on the side of the annular connecting disk 406 facing the conical guide structure 10, wherein the diameter of the second snap ring is larger than that of the first snap ring 407. Such a structure makes the contact portion between the annular connecting disk 406 and the conical guide structure 10 gradually shorten radially from the middle, and the structure is more stable. The annular connecting disk also includes a connecting rivet 409 and a wire hole 410 suitable for the wire to pass through. In a specific embodiment, as Figure 20 As shown, the tapered guide structure 10 further includes a wire channel 1006 suitable for passing a wire through. Figure 21 The angle α between the wire pulling channel 1006 and the central axis of the tapered guide structure 10 is not greater than 30° (not shown in the figure). The tapered guide structure 10 may include an insertion tube 1001 and a tapered outer shell 1002. The insertion tube may extend through the central opening of the annular connecting disk, and the end of the insertion tube may include a concave platform 1003 that is recessed toward the proximal end of the insertion tube for mating with a sealing ring. In addition, referring to Figure 15 At least three stepped baffles 1004 may be disposed within the conical housing and around the outer circumference of the insertion tube. These baffles 1004 extend axially along the insertion tube, and each baffle, facing the distal end of the insertion tube, includes a first groove 1007 and a second groove 1008, which are recessed toward the proximal end of the insertion tube. The first groove 1007 is closer to the insertion tube and is designed to mate with the first retaining ring 407. The second groove 1008 is closer to the conical housing 10002 and is designed to mate with the second retaining ring 408, achieving a double seal. The distal end of the conical guide structure 10 may also include a mounting hole 1005 for mate with a connecting rivet 409.

[0085] Next, the structure of the bending adjusting device 5 and the positional relationship between the bending adjusting device 5 and the tubular guide 4 will be briefly described.

[0086] refer to Figure 13-15 The heart valve delivery system 100 may further include a bend adjustment device 5, which includes a hollow channel adapted to accommodate an adjustable bend tube. The curvature of the adjustable bend tube is adjustable, for example, by a rotary handle and a pull wire provided on the bend adjustment device 5. The distal end of the bend adjustment device 5 is connected to the tubular guide 4, and the hollow channel of the bend adjustment device communicates with the hollow channel within the tubular guide 4, forming a hollow channel adapted to accommodate the adjustable bend tube.

[0087] 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 follows: Figure 16-20 As shown. The bending adjustment 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 adjustment 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 end opening of the housing 51 to adjust the circumferential movement of the guide member 53, the threaded tube 54, and the bending adjustment tube 70. The double-sided threaded sleeve 55 is sleeved on the outer circumference of the threaded tube 54 and is connected to the housing 51 having an internal thread through a threaded structure. The guide member 53 is relatively fixed to the housing 51, and a limit ring 531, a first guide rail 532, and a pull wire fixed end 533 are provided on the outer circumference of the guide member 53. The pull wire fixed end 533 can move axially along the first guide rail 532. The pull wire fixed end may include a through hole for fixing the pull wire, and a pull wire hole 56 suitable for the pull wire to pass through. The limit ring defines the farthest point that the pull wire fixed end can move.

[0088] The distal end of the threaded tube 54 and the fixed end 533 of the wire are independent entities for the convenience of assembly. The wire is in a tensioned state throughout the entire process. When moving toward the proximal end, the threaded tube 54 drives the fixed end of the wire to move. At this time, the tension of the wire gradually increases until it moves to the limit ring. When moving toward the distal end, the resistance of the threaded tube to the fixed end of the wire is removed due to the movement of the threaded tube toward the distal end. The fixed end of the wire moves toward the distal end with the threaded tube under the action of the restoring force. Notches are provided on both ends of the threaded tube to facilitate the passage of the wire and reduce the restriction of the threaded tube on the wire on both sides.

[0089] The bending adjustment device 5 further includes an anti-axial movement member 57 disposed at the distal end of the threaded tube 54, which engages with the housing 51 to prevent axial movement of the guide member 53. The bending adjustment device 5 may further include an anti-rotation member 58 disposed at the distal end of the anti-axial movement member 56, which engages with the housing 51 to prevent circumferential movement of the guide member 53.

[0090] Next, the catheter system, the structure of the proximal end of 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.

[0091] In one embodiment, reference Figure 3 as well as Figure 16-23, the distal end of the inner tube 40 is provided with an outward folding structure 401 to form a circular ring, the distal end of the middle tube 50 is provided with a first outward expansion structure 502, and the proximal end of the heart valve is clamped between the circular ring and the first outward expansion structure. In a preferred embodiment, the distal end of the outer tube 60 is provided with a second outward expansion structure 601, and the clamping point between the middle tube and the second outward expansion structure includes a fixing ring 501. The middle tube 50 is clamped with the second outward expansion structure 601 of the outer tube 60 through the fixing ring 501 to limit the radial displacement of the middle tube 50, thereby indirectly ensuring the stability of the clamping of the proximal end of the heart valve. In a preferred embodiment, the fixing ring 501 is provided with at least one shrinkage groove 506 connected to the outside along the axial direction, which is clamped with the distal end of the heart valve to limit the axial movement of the heart valve. Figure 3 In the illustrated embodiment, the constriction groove 506 may include a first opening 507 and a second opening 508 that are in communication, wherein the second opening 508 is closer to the proximal end of the heart valve than the first opening 507, and the circumferential dimension of the second opening 508 is smaller than the circumferential dimension of the first opening 507. Figure 24 After the outer tube 60 is placed over the retaining ring 501, the artificial valve's connecting block 2001 snaps into place within the first opening 507, while the connecting web 2003 passes through the second opening 508 and out of the constricted groove 506. Because the connecting block 2001 matches the shape of the first opening 507, it is confined within the first opening 507, preventing axial movement of the artificial valve. This, in turn, limits the axial movement of the artificial valve. However, the connecting block 2001 can expand radially outward due to its self-expansion force. After the outer tube 60 is removed from the retaining ring 501, the connecting block 2001 self-expands, releasing the distal end of the artificial valve.

[0092] The outer tube 60 extends through the end of the adjustable elbow and is secured to the outer circumference of the middle tube via a retaining ring. The inner tube 40 is secured to the outer circumference of the middle tube 50 and includes a guidewire hole at its end. When using this delivery device to deliver an aortic valve, the distal end of the valve is clamped between the middle and outer tubes, and the proximal end is clamped between the inner and middle tubes. In actual operation, an introducer is also attached to the outer surface of the valve to further secure it within the introducer's tube (the document does not show the introducer's structure).

[0093] Furthermore, as an example, Figure 24 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 diamond-shaped squares. An artificial heart valve 2100 may be sutured to the heart valve 2000.

[0094] Example 2

[0095] This embodiment provides a method for delivering a heart valve using a heart valve delivery system, comprising the following steps:

[0096] S1: A small hole is made in the left femoral artery. A guidewire is passed from the small hole through the femoral artery, the ascending aorta, across the aortic arch, and into the descending aorta. The dilator and outer sheath on the outside of the descending aorta are then introduced into the aorta along the guidewire. The dilator is removed, and the outer sheath forms a passage for the delivery system to enter and exit.

[0097] S2: The heart valve is pre-loaded into the delivery system using the introducer and passed through the outer sheath to the initially set position.

[0098] Remove the introducer and release the heart valve positioner;

[0099] Rotate the bending adjustment device 5 to adjust the heart valve to the central axis of the aorta;

[0100] Pull out the first latch 20, separate the externally threaded sleeve 3 and the tubular housing 2, rotate the tubular housing 2, drive the distal heart valve to rotate circumferentially, align the locator of the heart valve axially with the sinus floor of the aortic valve leaflet, and insert the latch;

[0101] The driving nut 8 is rotated to drive the tubular guide member 4 at the rear to move distally, and the heart valve positioner is steadily delivered to the sinus bottom of the aortic valve;

[0102] To release the heart valve, pull out the locking member 6 and push the release end 1 distally, driving the inner tube 40 to move distally. The proximal end of the heart valve is released, and the bottom rests on the aortic annulus. The outer wall of the heart valve and the positioner together clamp the aortic valve leaflets.

[0103] Rotate the release plate 7 and pull it back toward the proximal end, driving the outer tube 60 to move toward the proximal end, releasing the distal end of the heart valve and automatically expanding it to a predetermined size, and releasing the middle tube 50;

[0104] After confirming that the heart valve is clamped intact, the delivery system is pulled proximally out of the body to complete the implantation of the aortic valve.

[0105] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above and that the invention can be embodied in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as illustrative and non-restrictive, and the scope of the invention is defined by the appended claims, not the foregoing description, and all variations within the meaning and range of equivalents of the claims are intended to be included therein. Any reference sign in a claim should not be construed as limiting the claim to which it relates.

Claims

1. A bidirectionally movable and released heart valve delivery system, characterized in that: include: A catheter system for delivering an external heart valve to a target location, the catheter system comprising an inner tube, a middle tube, and an outer tube that are sequentially connected, the distal end of the inner tube being provided with a circular ring formed by an outward folding structure, the distal end of the middle tube being provided with a first outward expansion structure, and the proximal end of the heart valve being clamped between the circular ring and the first outward expansion structure; The distal end of the outer tube is provided with a second outward expansion structure, and the middle tube and the second outward expansion structure are connected at a clamping point including a fixing ring, the fixing ring is provided with at least one shrinkage groove in axial direction and connected to the outside, the shrinkage groove includes a first opening and a second opening in communication, wherein the second opening is closer to the proximal end of the heart valve than the first opening, and the circumferential size of the second opening is smaller than the circumferential size of the first opening, and the distal end of the heart valve is clamped in the shrinkage groove to limit its axial movement; The middle tube is clamped with the second outward expansion structure through the fixing ring to limit the radial displacement of the middle tube, thereby indirectly ensuring the stability of the clamping of the proximal end of the heart valve; The inner tube can be pushed forward axially to release the proximal end of the heart valve, and the outer tube can be withdrawn axially backward to release the distal end of the heart valve. The step-by-step release of the heart valve is achieved through the bidirectional independent movement of the inner tube and the outer tube.

2. The bidirectionally movable and released heart valve delivery system according to any one of claims 1, wherein: It also includes a catheter system guide structure, which includes a tubular guide member and a conical guide structure connected to each other, the proximal end of the tubular guide member is connected to the distal end of the conical guide structure, and the inner tube, middle tube and outer tube in the catheter system all pass through the tubular guide member and extend a predetermined distance through the proximal end of the conical guide structure.

3. The bidirectionally movable and released heart valve delivery system according to claim 2, wherein: The proximal end of the tubular guide piece is connected to the distal end of the tapered guide structure through a connecting nut. The proximal end of the tubular guide piece is provided with an external thread that matches the internal thread of the connecting nut.

4. The bidirectionally movable and released heart valve delivery system according to claim 3, wherein: An annular connecting disk is provided between the proximal end of the tubular guide member and the distal end of the conical guide structure; The conical guide structure includes an insertion tube and a conical outer shell, and the insertion tube extends through the central opening of the annular connecting disk.

5. The bidirectionally movable and released heart valve delivery system according to claim 4, wherein: The annular connecting disk includes a wire hole suitable for the wire to pass through, and the tapered guide structure includes a wire channel suitable for the wire to pass through.

6. The bidirectionally movable and released heart valve delivery system according to claim 5, wherein: An included angle α between the wire pulling channel and the central axis of the tapered guide structure is no greater than 30°.

7. The bidirectionally movable and released heart valve delivery system according to claim 4, wherein: A first clamping ring and a second clamping ring are provided on the side of the annular connecting disk facing the conical guide structure, wherein the diameter of the second clamping ring is larger than that of the first clamping ring; The conical guide structure includes a stepped baffle arranged inside the conical outer shell and on the outer periphery of the insertion tube. The stepped baffle extends along the axial direction of the insertion tube, and the end of each baffle facing the distal end of the insertion tube includes a first groove and a second groove recessed toward the proximal end of the insertion tube. The first groove is closer to the insertion tube and is used to cooperate with the first retaining ring. The second groove is closer to the conical outer shell and is used to cooperate with the second retaining ring to achieve double sealing.

8. The bidirectionally movable and released heart valve delivery system according to claim 4, wherein: The end of the insertion tube comprises a recessed platform which is recessed toward the proximal end of the insertion tube and is used for cooperating with the sealing ring.

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