Delivery System for Delivering a Valve Graft

Abstract

The present invention discloses a delivery system, comprising: an outer sheath tube, the proximal end of which is adapted to receive a valve graft in a first compressed state and is arranged to be operably moved axially to release the valve graft to a second compressed state; a translation assembly, arranged to receive and compress the distal end of the valve stent and operably translate the valve graft in the second compressed state to a desired position; a torsion assembly, arranged to operably rotate the valve graft in the second compressed state to a desired position; and a guide head assembly, arranged to receive and compress the proximal end of the valve stent, wherein the guide head assembly and the translation assembly are arranged to operably release the valve graft in the second compressed state to a released state. The delivery system of the present invention adopts a transfemoral delivery method, which can enable the valve graft to rotate and translate around the axis in vivo to align the valve clip with the bottom of the leaflet sinus, and can ensure the sequential release of the valve graft.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more specifically, to a delivery system for delivering a valve graft. Background Art

[0002] Current artificial aortic valve grafts are generally used to treat two diseases: calcification and pure leaflet regurgitation. For treating the calcification disease, the valve implant is directly released after being delivered to the leaflet position, and only the axial position needs to be concerned about during the positioning process; while for treating the pure regurgitation disease, the valve implant needs to be positioned and released in batches after being delivered to the leaflet position, that is, the positioning member outside the valve stent is released first, and finally the valve stent is released. During the positioning process, the valve clip needs to be aligned with the bottom of the leaflet sinus.

[0003] The valve implant can usually be delivered to the required position through the delivery method via the apex of the heart and the delivery method via the femoral artery. For the delivery method via the apex of the heart, the delivery path is short and the delivery system rotates directly; for the delivery method via the femoral artery, the delivery path is long, and the delivery process needs to pass through the curved aortic arch, resulting in great difficulty in rotational positioning and release.

[0004] Therefore, for the delivery method of the valve graft via the femoral artery, it is necessary to solve problems such as the long-distance axial delivery of the valve graft in the body, how the valve graft rotates around the axis in the body to align the valve clip with the bottom of the leaflet sinus, and how the valve graft is released in batches. Summary of the Invention

[0005] In view of this, the present invention provides a delivery system for delivering a valve graft that can solve the aforementioned problems. Among them, the valve graft (7) includes a valve stent (71) and a positioning member (72) connected to the outside of the valve stent. The valve graft (7) has a first compressed state in which both the valve stent (71) and the positioning member (72) are compressed, a second compressed state in which the valve stent (71) is compressed and the positioning member (72) is released, and a released state in which both the valve stent (71) and the positioning member (72) are released. The delivery system includes: an outer sheath tube (11), the proximal end of the outer sheath tube is adapted to receive and compress the valve graft so that the valve is in the first compressed state, and the outer sheath tube is arranged to be operably moved axially to release the positioning member (72) to release the valve graft to the second compressed state; a translation assembly (3), the translation assembly is arranged to receive and compress the distal end of the valve stent (71) and is operably moved axially to translate the valve graft in the second compressed state to the desired position; a torsion assembly (4), the torsion assembly is arranged to operably rotate the valve graft in the second compressed state to position the valve graft to the desired position; and a guide head assembly (5), the guide head assembly is arranged to receive and compress the proximal end of the valve stent (71), wherein the guide head assembly (5) and the translation assembly (3) are arranged to be operably moved axially to respectively release the proximal end and the distal end of the valve stent (71) to release the valve graft in the second compressed state to the released state.

[0006] In some embodiments, the translation assembly (3) includes a translation catheter (31) and a first sleeve (32) rotatably connected to the proximal end of the translation catheter. The translation catheter and the first sleeve are axially received in the outer sheath tube (11), and the first sleeve is adapted to receive and compress the distal end of the valve stent (71); the torsion assembly (4) includes a torsion spring (41) and a locking buckle (42) connected to the proximal end of the torsion spring. The torsion spring is axially received in the translation catheter (31), the locking buckle (42) is received in the first sleeve (32) and is movably connected to the first sleeve (32). The torsion assembly is arranged to drive the first sleeve (32) and the valve graft to rotate by rotating the torsion spring; the guide head assembly (5) includes a guide tube (51), a guide head (52) connected to the proximal end of the guide tube (51), and a second sleeve (54) rotatably connected to the distal end of the guide head (52) and sleeved outside the guide tube. The guide tube is axially received in the torsion spring, the guide head extends axially outside the outer sheath tube, and the second sleeve is adapted to receive and compress the proximal end of the valve stent (71).

[0007] In some embodiments, the delivery system further includes: an adjustable bending assembly (2), the adjustable bending assembly includes an adjustable bending catheter (21) and a steel cable (22) axially attached to one side of the adjustable bending catheter, the adjustable bending catheter is axially located between the outer sheath tube and the translation catheter, and the adjustable bending catheter is configured to be bendable to drive the bending of the outer sheath tube (11), the translation catheter (31), the torsion spring (41), and the guiding tube (51).

[0008] In some embodiments, the delivery system further includes: a first handle assembly and a second handle assembly. The first handle assembly includes: an outer sheath tube handle (12), the outer sheath tube handle is connected to the distal end of the outer sheath tube for controlling the axial movement of the outer sheath tube; and an adjustable bending handle (23), the adjustable bending handle is connected to the distal end of the adjustable bending catheter, and is used to control the bending of the adjustable bending catheter by pulling the steel cable. Wherein, the outer sheath tube handle is located at the proximal end of the adjustable bending handle, a slide rail (24) is provided outside the adjustable bending catheter, and the slide rail is located between the outer sheath tube handle and the adjustable bending handle for the outer sheath tube handle to control the axial movement of the outer sheath tube; The second handle assembly includes: a translation handle (33), the translation handle is connected to the distal end of the translation catheter for controlling the axial movement of the translation catheter; a torsion handle (43), the torsion handle is connected to the distal end of the torsion spring for controlling the rotation of the torsion spring; and a guiding head handle (53), the guiding head handle is connected to the distal end of the guiding tube for controlling the axial movement of the guiding head tube. Wherein, the translation handle (33), the torsion handle (43), and the guiding head handle (53) are sequentially connected in the axial direction from the proximal end to the distal end.

[0009] In some embodiments, the first handle assembly and the second handle assembly are detachably connected by a connection structure (6). The connection structure (6) includes a pair of connection support rods (61), the connection support rod includes a fixed end (611) and a free end (612), the fixed end (611) is fixedly connected to the adjustable bending handle (23) of the first handle assembly, and the free end (612) is configured to be detachably inserted into the translation handle (33) of the second handle assembly.

[0010] In some embodiments, the second handle assembly further includes a housing (8), the translation handle, the torsion handle, and the guiding head rotating handle are axially received in the housing, and the translation handle is axially movable operably with the housing, the torsion handle is rotatable operably with the housing, and the guiding head handle is axially movable operably with the housing.

[0011] In some embodiments, a fixing groove is provided on the slide rail (24), and a locking pin is provided on the outer sheath tube handle. The locking and unlocking between the outer sheath tube and the adjustable bending assembly are achieved through the mutual cooperation of the locking pin and the fixing groove of the slide rail.

[0012] In some embodiments, the translation handle and the torsion handle are both provided with locking pins to achieve the locking and unlocking of the translation assembly and the torsion spring assembly, and a locking clip is provided at the distal center of the guide head handle to achieve the locking and unlocking of the guide head assembly.

[0013] In some embodiments, the torsion spring is a single-strand spring, a multi-strand spring processed from a metal wire, a corrugated pipe formed by cutting a metal pipe, or a composite pipe composed of the above components and plastics.

[0014] Adopting the embodiments of the present invention has the following beneficial effects:

[0015] Through the torsion spring of the torsion assembly, the torsional movement outside the body can be synchronously transmitted to the valve graft through the curved pipe, so that the valve graft rotates to a suitable position. At the same time, the connection settings between the first sleeve of the translation assembly and the second sleeve of the guide head assembly and the torsion spring enable the valve stent to rotate freely at both the distal end and the proximal end, and can convert the torsional angle outside the body with the lowest resistance.

[0016] After the outer sheath tube is withdrawn, the first sleeve of the translation assembly and the second sleeve of the guide head assembly can both continue to restrain the valve stent and keep the valve graft in the second compressed state, making it more convenient to rotate the valve graft in the body. And the second sleeve is preferably made of fabric, which has the advantages of flexibility and a thinner thickness, and its shape can be cylindrical or conical.

[0017] The outer sheath tube and the adjustable bending assembly can be operably locked and unlocked, so that the outer sheath tube and the adjustable bending catheter can be fixed as a curved transportation channel during the transportation process and the release process. The axial movement of the translation catheter is not restricted, which can improve the accuracy of the axial movement of the valve graft. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a schematic diagram of a delivery system in use according to an embodiment of the present invention;

[0019] Figure 2 is Figure 1 a partial cross-sectional view of the delivery system shown;

[0020] Figure 3 is Figure 1 a three-dimensional schematic diagram of the delivery system shown;

[0021] Figure 4 is Figure 1Partial sectional view of the shown delivery system;

[0022] Figure 5A is Figure 1 Schematic diagram of the structure when the connection structure of the shown delivery system is disconnected;

[0023] Figure 5B is Figure 1 Schematic diagram of the structure when the connection structure of the shown delivery system is connected;

[0024] Figure 6 is Figure 1 Schematic diagram of the structure of the outer sheath tube, adjustable bending assembly and handle of the shown delivery system;

[0025] Figure 7 is Figure 1 Schematic diagram of the structure of the outer sheath tube and the outer sheath tube handle of the shown delivery system;

[0026] Figure 8 is Figure 1 Partial sectional view of the outer sheath tube and the outer sheath tube handle of the shown delivery system;

[0027] Figure 9 is Figure 1 Partial sectional view of the adjustable bending assembly and the adjustable bending handle of the shown delivery system;

[0028] Figure 10 is Figure 1 Schematic diagram of the structure of the translation assembly and the handle of the shown delivery system;

[0029] Figure 11 is Figure 1 Schematic diagram of the structure of the torsion assembly and the handle of the shown delivery system;

[0030] Figure 12 is Figure 1 Schematic diagram of the connection relationship between the valve graft delivered by the shown delivery system and the torsion assembly;

[0031] Figure 13 is Figure 1 Schematic diagram of the structure of the guide head assembly and the handle of the shown delivery system;

[0032] Figure 14 is Figure 1 Schematic diagram of the outer shell of the shown delivery system;

[0033] Figure 15 is Figure 1 Schematic diagram of the delivery and release of the valve graft delivered by the shown delivery system;

[0034] Figure 16 Schematic diagram of another valve graft in the human blood vessel;

[0035] Figure 17 is Figure 1 transported by the delivery system shown Figure 16 Schematic diagram of the delivery and release of the valve graft shown Detailed implementation mode

[0036] The following elaborates on various aspects of the present invention in conjunction with the accompanying drawings and specific implementation modes. Among them, the components in the drawings are not necessarily drawn to scale, and the emphasis is on exemplifying the principles of the present invention

[0037] In various implementation modes of the present invention, well-known structures, materials, or operations are not shown or described in detail. Moreover, the described features, structures, or characteristics can be combined in any manner in one or more implementation modes. In addition, those skilled in the art should understand that the following various implementation modes are only for illustration and not for limiting the protection scope of the present invention. It can also be easily understood that the elements or components in the implementation modes described herein and shown in the drawings can be arranged and designed in a variety of different configurations

[0038] Figure 1 is a schematic diagram of the delivery system in use according to an implementation mode of the present invention Figure 2 is Figure 1 a partial sectional view of the delivery system shown Figure 3 is Figure 1 a three-dimensional schematic diagram of the delivery system shown Figure 4 is Figure 1 a partial sectional view of the delivery system shown

[0039] As Figures 1 to 4 shown, in this implementation mode, the delivery system for delivering the valve graft includes: an outer sheath 11, an adjustable bending assembly 2, a translation assembly 3, a torsion assembly 4, a guide head assembly 5, and a handle assembly

[0040] As Figure 2 shown, the valve graft 7 includes a valve stent 71 and a positioning member 72 connected to the outside of the valve stent (in this implementation mode, the positioning member is a valve clip). Among them, the valve clip 72 is detachably connected to the outside of the valve stent 71 and has 3 clamping portions evenly distributed in the circumferential direction for clamping the human valve leaf between the valve clip and the valve stent, thereby restricting the movement of the valve graft and positioning the valve graft to the desired position. In an alternative implementation mode, the graft that the delivery system can transport is not limited to this. The valve clip can also be fixedly connected to the outside of the valve stent, the number of clamping portions can also be changed as needed, and the positioning member can also be a protrusion or a protruding rod extending outward from the valve stent that can press against the human valve leaf (such as Figures 16 to 17The three protruding members 72 evenly distributed circumferentially along the valve stent as shown (the number and position of the protruding members can also be changed according to needs), etc., as long as they can limit the movement of the valve graft and have a positioning member with two states of compression and release are acceptable.

[0041] The valve graft 7 has a first compressed state, a second compressed state, and a released state. Among them, the first compressed state is the state in which both the valve stent 71 and the valve clip 72 are compressed, the second compressed state is the state in which the valve stent 71 is compressed while the valve clip 72 is released, and the released state is the state in which both the valve stent 71 and the valve clip 72 are released.

[0042] As Figure 2 、 Figure 6 and Figure 7 shown, the proximal end of the outer sheath 11 is adapted to receive and compress the valve graft 7 to make the valve in the first compressed state, and the outer sheath 11 is arranged to be operably moved axially to release the valve clip 72 to make the valve graft released to the second compressed state. Specifically, the outer sheath 11 is moved by the control of the outer sheath handle 12 connected to the distal end of the outer sheath 11. A slider 13 is provided in the outer sheath handle 12, and the outer sheath 11 is operably moved axially by moving the outer sheath handle 12.

[0043] Combined with Figures 6 to 9As shown, the bendable component 2 includes a bendable catheter 21 and a steel cable 22 axially attached to one side of the bendable catheter 21. The bendable catheter 21 is axially received within the outer sheath 11, and the diameter of the outer sheath 11 is greater than that of the bendable catheter 21. The bendable component 2 is bent by the control of a bendable handle 23, which is connected to the distal end of the bendable catheter 21 and is connected to the steel cable 22. By pulling the steel cable 22, the bendable catheter 21 is controlled to bend, thereby driving the bending of the outer sheath 11 and other catheters received within the outer sheath 11. The bendable handle 23 is provided at the distal end of the outer sheath handle 12. A slide rail 24 is further provided outside the bendable catheter, and the slide rail 24 is located between the outer sheath handle 12 and the bendable handle 23 for the outer sheath handle 12 to control the axial movement of the outer sheath 11. The bendable component and the outer sheath component can be locked, and there is only axial movement between the bendable catheter and the outer sheath, and no rotation is allowed. Specifically, a fixing groove 241 is provided on the slide rail 24, and a locking pin 14 is provided on the outer sheath handle 12. The locking and unlocking between the outer sheath component and the bendable component are achieved through the mutual cooperation of the locking pin 14 and the fixing groove 241 of the slide rail: during transportation, the outer sheath component and the bendable component are locked and do not move axially relative to each other, and the locking pin 14 falls into the fixing groove 241; after the delivery system reaches the expected position, the locking pin 14 is pulled out, and the two are unlocked. At this time, the outer sheath can move along the slide rail 24, and the outer sheath 11 is controlled by the outer sheath handle 12 to move distally and then retreat along the slide rail 24 to release the valve clip 72 of the valve graft.

[0044] A tension slider 25 is further provided within the bendable handle 23. There is a threaded fit between the bendable handle 23 and the tension slider 25. By rotating the bendable handle 23, the slider 25 moves left and right (axially), thereby stretching the steel cable 22 and bending the bendable catheter 21.

[0045] Combined Figure 10 As shown, the translation component 3 is configured to receive and compress the distal end of the valve stent 71. Specifically, the translation component 3 includes a translation catheter 31 and a first sleeve 32 rotatably connected to the proximal end of the translation catheter. The translation catheter and the first sleeve are axially received within the bendable catheter 21 and extend out of the bendable catheter 21 into the outer sheath 11. The first sleeve 32 is adapted to receive and compress the distal end of the valve stent 71 to hold the valve graft in the second compressed state. Moreover, the translation component is configured to be operably moved axially to translate the valve graft in the second compressed state to the expected position. Specifically, the translation component is operably moved axially by a translation handle 33, and the translation handle 33 is connected to the distal end of the translation catheter 31 for controlling the axial movement of the translation catheter 31. A locking pin is provided on the translation handle 33, that is, the translation handle 33 is a locking handle, and normal operation can be carried out only after the pin is unscrewed to prevent misoperation.

[0046] As shown in combination with Figures 11 to 12 shown, the torsion assembly 4 is arranged to operably rotate the valve graft 7 in the second compressed state to position the valve graft to the desired position. Specifically, the torsion assembly 4 includes a torsion spring 41 and a locking buckle 42 connected to the proximal end of the torsion spring 41. The torsion spring 41 is axially received in the translation catheter 31, and the locking buckle 42 is received in the first sleeve 32 and is movably connected to the first sleeve. Among them, the torsion spring 41 and the locking buckle 42 are fixedly connected, and the locking buckle 42 can rotate and slide relative to the first sleeve 32. The cooperation between the two can completely fix the distal end of the valve stent 71. When the torsion assembly is rotated, the rotational torque is transmitted to the locking buckle 42 through the torsion spring 41, causing the torsion spring 41 and the locking buckle 42 to rotate, so as to drive the first sleeve 32 and the valve graft 7 to rotate. The torsion assembly 4 is rotated by a torsion handle 43 connected to the distal end of the torsion spring 41. The torsion spring 41 and the torsion handle 43 are fixedly connected. When the torsion handle 43 is rotated, the torsion spring 41 can be driven to rotate. A locking pin is also provided on the torsion handle 43, that is, the torsion handle 43 is a locking handle, and normal operation can only be carried out after the pin is removed to prevent misoperation. In the present invention, the torsion spring is a general term for torque-transmitting members, which can specifically be a single-strand spring, a multi-strand spring processed from metal wire, a bellows formed by cutting a metal tube, or a composite tube composed of the above components and plastics.

[0047] As shown in combination with Figure 13 shown, the guide head assembly 5 includes a guide tube 51, a guide head 52 connected to the proximal end of the guide tube 51, and a second sleeve 54 rotatably connected to the distal end of the guide head 52 and sleeved outside the guide tube 51. The guide tube 51 is axially received in the torsion spring 41, passes through the torsion spring 41, the translation catheter 31 axially, and extends into the outer sheath tube 11, so that the guide head 52 extends axially outside the outer sheath tube 11. The second sleeve 54 is adapted to receive and compress the proximal end of the valve stent 71.

[0048] The guide head assembly 5 can be operably moved axially through a guide head handle 53 connected to the distal end of the guide tube 51 to release the proximal end of the valve stent 71. Specifically, a guide head moving seat 55 connected to the guide tube 51 is provided inside the guide head handle 53. The guide head moving seat 55 and the guide head handle 53 are in threaded cooperation. By rotating the guide head handle 53, the guide head moving seat 55 moves axially to drive the axial movement of the guide tube 51. A locking clip 56 is also provided at the distal end of the guide head handle 53. The locking clip clamps the guide tube 51 in a threaded manner to lock the guide tube 51 from moving, thereby preventing misoperation.

[0049] In the present invention, the shape of the second sleeve 54 can be cylindrical, conical, or a combination of cylindrical and conical shapes. It can be made of metal, plastic, or fabric. The second sleeve 54 is sleeved on the outside of the distal end of the guide head 52 and is rotatably connected to the distal end of the guide head 52.

[0050] In this embodiment, if Figures 5A to 5B As shown, the outer sheath handle 12 and the adjustable bend handle 23 constitute a first handle assembly, and the translation handle 33, the twist handle 43, and the guide head rotation handle 53 are sequentially connected along the axial direction from the proximal end to the distal end to constitute a second handle assembly. The adjustable bend handle 23 of the first handle assembly and the translation handle 33 of the second handle assembly are detachably connected via a connecting structure 6. During the delivery of the valve graft, the connecting structure 6 connects the adjustable bend handle 23 of the first handle assembly and the translation handle 33 of the second handle assembly; during the positioning and release of the valve graft, the connecting structure 6 disconnects the adjustable bend handle 23 of the first handle assembly and the translation handle 33 of the second handle assembly, so that the translation assembly and the twist assembly can move and rotate in the body, thereby facilitating the positioning of the valve graft in the body.

[0051] Specifically, the connecting structure 6 includes a connecting support rod 61, a fixed cylinder 62 and a locking pin 63 arranged in pairs. The fixed cylinder 62 is arranged on the translation handle 33 and connected to the translation handle 33. The locking pin 63 is arranged on the fixed cylinder 62. The connecting support rod 61 includes a fixed end 611 and a free end 612. The fixed end 611 is fixedly connected to the adjustable bending handle 23. The free end 612 is configured to be detachably inserted into the fixed cylinder 62. The locking pin 63 is inserted to clamp the fixed cylinder 62 and the free end 612 to achieve the connection between the translation handle 33 and the adjustable bending handle 23. The locking pin 63 is pulled out to make the free end detach from the fixed cylinder 62 to disconnect the connection between the translation handle 33 and the adjustable bending handle 23.

[0052] During the delivery of the transplant, the locking pin 63 is always inserted into the groove of the fixed sleeve 62 to lock the fixed sleeve 62 and the free end 612 of the support rod, thereby maintaining the connection between the translation handle 33 and the adjustable bending handle 23; during the positioning and release of the transplant, the locking pin 63 is pulled up (rotated) to move it upward to disengage from the groove in the fixed sleeve 62, thereby unlocking the connecting support rod and the fixed sleeve 62 and allowing the fixed sleeve to move horizontally. The connecting support rod 61 can thus be rotated to disengage the free end 612 from the fixed sleeve 62 to disconnect the connection between the translation handle 33 and the adjustable bending handle 23, so that the second handle assembly can be moved, rotated, etc. accordingly, which facilitates the positioning of the transplant in the body.

[0053] In an embodiment of the present invention, Figure 14As shown, the second handle assembly further includes a housing 8. The translation handle 33, the torsion handle 43, and the seeker rotation handle 53 are axially received in the housing 8. The translation handle is operably axially movable with respect to the housing and has only axial movement freedom. The torsion handle is operably rotatable with respect to the housing and has only rotational freedom. The seeker handle is operably axially movable with respect to the housing and has only movement freedom.

[0054] In the present invention, the delivery system is configured such that:

[0055] The valve graft in the first compressed state is received in the outer sheath tube. During delivery, the outer sheath tube and the steerable assembly are locked. Rotate the steerable handle to pull the steel cable so that the steerable catheter bends to drive the outer sheath tube and other catheters (translation catheter, torsion spring, and guide catheter) inside it to bend. When the valve graft in the first compressed state is delivered to the position of the ascending aortic root, unlock the outer sheath tube and the steerable assembly. Control the outer sheath tube to move axially distally through the outer sheath tube handle to release the positioning member of the valve graft to make it in the second compressed state. At this time, the positioning member is released, and the proximal and distal ends of the valve stent are still compressed by the translation assembly and the seeker assembly. Then lock the position of the outer sheath tube and the steerable assembly in the body. Then control the translation assembly (translation catheter and first sleeve) to move axially along the outer sheath tube to deliver the valve graft to the aortic valve position. When the valve graft is delivered to the aortic valve position, rotate the torsion handle to rotate the torsion assembly (torsion spring and locking buckle) to drive the first sleeve and the valve graft to rotate. When the first sleeve and the valve graft rotate, the second sleeve rotates around the seeker accordingly. By repeatedly operating the translation catheter assembly and the torsion assembly, the valve graft reaches the desired posture. Then move the seeker assembly axially proximally to remove the second sleeve and release the proximal end of the valve stent. When the proximal end of the valve stent is released, control the translation assembly (translation catheter and first sleeve) to move axially distally to remove the first sleeve and release the distal end of the valve stent, so that the valve graft is completely released and in the released state.

[0056] As Figure 15 and Figure 17 shown, the delivery system according to an embodiment of the present invention is delivered to the desired position through the peripheral blood vessel, and its delivery and release include the following steps:

[0057] (a), Bend the steerable catheter so that the delivery system passes through the curved aortic arch and finally reaches the position of the ascending aortic root;

[0058] (b), Unlock the outer sheath tube and the steerable assembly, and retract the outer sheath tube to release the valve graft. At this time, the valve positioning member (for exampleFigure 15 the valve clip 72 in Figure 17 or the protruding member 72) in

[0059] (c) Rotate and move the valve implant in the axial direction through the torsion assembly and the translation assembly so that the valve clip accurately enters the sinus bottom;

[0060] (d) When the position and angle of the valve graft reach the expectation, move the seeker assembly proximally to remove the second sleeve that presses and holds the proximal end of the valve stent, so that the proximal end of the valve stent is completely released;

[0061] (e) Move the translation assembly distally to remove the first sleeve that presses and holds the distal end of the valve stent, so that the distal end of the valve stent is completely released, thereby completely releasing the valve graft into the released state.

[0062] The terms and phrases used in the specification of the present invention are for illustrative purposes only and do not constitute a limitation. Those skilled in the art should understand that various changes can be made to the details of the above embodiments without departing from the basic principles of the disclosed embodiments. Therefore, the protection scope of the present invention is only determined by the claims, and in the claims, unless otherwise specified, all terms should be understood in the broadest reasonable sense.

Claims

1. A delivery system for delivering a valve graft, wherein, The valve graft (7) includes a valve stent (71) and a positioning member (72) connected to the outside of the valve stent. The valve graft (7) has a first compressed state in which both the valve stent (71) and the positioning member (72) are compressed, a second compressed state in which the valve stent (71) is compressed and the positioning member (72) is released, and a released state in which both the valve stent (71) and the positioning member (72) are released. It is characterized in that the delivery system includes: An outer sheath tube (11), the proximal end of the outer sheath tube is adapted to receive and compress the valve graft so that the valve graft is in the first compressed state, and the outer sheath tube is arranged to be operably moved axially to release the positioning member (72) so that the valve graft is released to the second compressed state; A translation assembly (3), the translation assembly is arranged to receive and compress the distal end of the valve stent (71) and is operably moved axially to translate the valve graft in the second compressed state to the desired position; A torsion assembly (4), the torsion assembly is arranged to operably rotate the valve graft in the second compressed state so that the valve graft is positioned to the desired position; and A guide head assembly (5), the guide head assembly is arranged to receive and compress the proximal end of the valve stent (71), wherein the guide head assembly (5) and the translation assembly (3) are arranged to be operably moved axially to respectively release the proximal end and the distal end of the valve stent (71) to release the valve graft in the second compressed state to the released state; wherein the translation assembly (3) includes a translation catheter (31) and a first sleeve (32) rotatably connected to the proximal end of the translation catheter. The translation catheter and the first sleeve are axially received in the outer sheath tube (11), and the first sleeve is adapted to receive and compress the distal end of the valve stent (71); wherein the torsion assembly (4) includes a torsion spring (41) and a locking buckle (42) connected to the proximal end of the torsion spring. The torsion spring is axially received in the translation catheter (31), the locking buckle (42) is received in the first sleeve (32) and is movably connected to the first sleeve (32), and the torsion assembly is arranged to drive the first sleeve (32) and the valve graft to rotate by rotating the torsion spring; wherein the guide head assembly (5) includes a guide tube (51), a guide head (52) connected to the proximal end of the guide tube (51), and a second sleeve (54) rotatably connected to the distal end of the guide head (52) and sleeved outside the guide tube. The guide tube is axially received in the torsion spring, the guide head extends axially outside the outer sheath tube, and the second sleeve is adapted to receive and compress the proximal end of the valve stent (71); wherein the delivery system further includes: Adjustable bending assembly (2), the adjustable bending assembly includes an adjustable bending catheter (21) and a steel cable (22) axially attached to one side of the adjustable bending catheter. The adjustable bending catheter is axially located between the outer sheath tube and the translation catheter, and the adjustable bending catheter is configured to be bendable to drive the bending of the outer sheath tube (11), translation catheter (31), torsion spring (41) and guiding tube (51).

2. The conveying system according to claim 1, wherein The delivery system further includes: A first handle assembly, the first handle assembly includes: An outer sheath tube handle (12), the outer sheath tube handle is connected to the distal end of the outer sheath tube for controlling the axial movement of the outer sheath tube; An adjustable bending handle (23), the adjustable bending handle is connected to the distal end of the adjustable bending catheter, and is used to control the bending of the adjustable bending catheter by pulling the steel cable; Wherein, the outer sheath tube handle is located at the proximal end of the adjustable bending handle, and a slide rail (24) is provided outside the adjustable bending catheter. The slide rail is located between the outer sheath tube handle and the adjustable bending handle for the outer sheath tube handle to control the axial movement of the outer sheath tube; A second handle assembly, the second handle assembly includes: A translation handle (33), the translation handle is connected to the distal end of the translation catheter for controlling the axial movement of the translation catheter; A torsion handle (43), the torsion handle is connected to the distal end of the torsion spring for controlling the rotation of the torsion spring; and A guiding head handle (53), the guiding head handle is connected to the distal end of the guiding tube for controlling the axial movement of the guiding tube, Wherein, the translation handle (33), torsion handle (43) and guiding head handle (53) are sequentially connected axially from the proximal end to the distal end.

3. The conveying system according to claim 2, wherein, The first handle assembly and the second handle assembly are detachably connected by a connection structure (6).

4. The conveying system according to claim 3, characterized in that, The connection structure (6) includes a pair of connection support rods (61), the connection support rod includes a fixed end (611) and a free end (612). The fixed end (611) is fixedly connected to the adjustable bending handle (23) of the first handle assembly, and the free end (612) is configured to be detachably inserted into the translation handle (33) of the second handle assembly.

5. The conveying system according to claim 2, wherein The second handle assembly further includes a housing (8), the translation handle, torsion handle and guiding head rotating handle are axially received in the housing, and the translation handle is operably axially movable relative to the housing, the torsion handle is operably rotatable relative to the housing, and the guiding head handle is operably axially movable relative to the housing.

6. The conveying system according to claim 2, wherein The slide rail (24) is provided with a fixing groove, and the outer sheath tube handle is provided with a locking pin. The locking and unlocking between the outer sheath tube and the adjustable bending assembly are achieved through the mutual cooperation of the locking pin and the fixing groove of the slide rail.

7. The conveying system according to claim 2, wherein The translation handle and the torsion handle are both provided with locking pins to achieve the locking and unlocking of the translation assembly and the torsion assembly, and a locking clip is provided at the distal end of the guiding head handle to achieve the locking and unlocking of the guiding head assembly.

8. The conveying system according to claim 2, wherein, The torsion spring is a single-strand spring, multi-strand spring, bellows formed by cutting a metal tube, or a composite tube composed of the above components and plastic, which is processed from a metal wire.

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