A sutureless valve stent delivery device

Abstract

The application provides a kind of suture-free valve stent conveying device, including suture-free stent, conveying sleeve and bending adjusting assembly;The outflow of the suture-free stent is provided with a load bag for accommodating biological valve, and a tightening line is arranged on the load bag;The conveying sleeve includes an inner tube, a composite tube and an outer hose which are sequentially nested, the distal end of the inner tube is provided with a front sleeve, the front sleeve is sleeved on the inflow of the suture-free stent, the distal end of the outer hose is provided with a rear sleeve, and the rear sleeve is sleeved on the outflow of the suture-free stent, the bending adjusting assembly is connected to the proximal end of the inner tube and the composite tube respectively, for driving the composite tube to bend, and releasing the suture-free stent.The self-locking stent structure of the suture-free valve realizes the rapid and accurate implantation of surgical valve, and optimizes the effective opening area of the valve.

Description

Technical Field

[0001] This invention belongs to the field of medical devices and relates to the delivery of biological valves, and more particularly to a sutureless valve stent delivery device. Background Technology

[0002] Transcatheter valve replacement (TCV) has become an important treatment for aortic valve disease due to its minimal invasiveness and rapid recovery. During valve replacement, a catheter delivery device is used to deliver the new valve to the lesion site, where it is then precisely released and fixed. Currently, traditional surgical bioprosthetic valve implantation relies on manual sutures to fix the valve to the patient's valve annulus. The sutures are passed through the suture ring of the implanted new valve, and the valve is then delivered along the sutures to the target location. Finally, the sutures are tightened and knotted for fixation.

[0003] CN109789293A discloses a system for delivering intravascular devices to the mitral valve annulus, including a handle assembly, an elongated delivery component, an outer sheath, a steering catheter, a delivery catheter, and a suture catheter. The suture catheter is capable of longitudinal translation relative to the delivery catheter, enabling effective delivery, deployment, and repositioning of the device within the blood vessel. CN118252658A discloses a valve suture device including a delivery tube, a puncture needle channel, an exit needle, a puncture needle, and an auxiliary support assembly. Through the cooperation of the puncture needle and the auxiliary support assembly, the valve suture device can be stably inserted into the valve, facilitating valve suturing.

[0004] However, artificial valve suturing is time-consuming, places a heavy burden on cardiopulmonary bypass, is technically demanding, requires highly skilled operators, and carries the risk of complications. For example, loose suture knots or improper suturing can cause blood to leak through the gap between the suture and tissue, leading to paravalvular leakage; overly tight suture knots can compress and deform the valve suture ring, reducing the opening area and causing a mismatch between the valve and the patient, severely impacting surgical safety and wound healing.

[0005] Therefore, how to provide a sutureless valve stent and its delivery device to achieve stable and precise valve delivery has become an urgent technical problem to be solved. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a sutureless valve stent delivery device, which replaces traditional suture fixation with a self-locking stent structure of the sutureless valve, realizes rapid and accurate implantation of surgical valves, and significantly optimizes the effective opening area of ​​the valve.

[0007] To achieve this objective, the present invention adopts the following technical solution:

[0008] This invention provides a sutureless valve stent delivery device, comprising a sutureless stent, a delivery cannula, and a bending adjustment assembly. The sutureless stent includes an outflow channel and an inflow channel. A purse-string carrier is disposed within the outflow channel to accommodate a bioprosthetic valve, and a tightening line is threaded onto the purse-string carrier. The delivery cannula has a proximal end and a distal end, comprising an inner tube, a composite tube, and an outer flexible tube arranged in sequence. A front sleeve is disposed at the distal end of the inner tube and is fitted into the inflow channel of the sutureless stent. A rear sleeve is disposed at the distal end of the outer flexible tube and is fitted into the outflow channel of the sutureless stent, with the outflow channel facing the proximal end. The bending adjustment assembly is connected to the proximal ends of the inner tube and the composite tube, respectively, for driving the composite tube to bend and releasing the sutureless stent.

[0009] As a preferred embodiment of the present invention, the composite tube comprises an intermediate tube and an outer sheath tube that are sequentially nested together.

[0010] The distal end of the intermediate tube is fixedly connected to the distal end of the outer sheath tube. The proximal end of the intermediate tube and the proximal end of the outer sheath tube are respectively provided with a bending control fixing component and an outer sheath tube fixing component. The outer sheath tube fixing component is located at the distal end of the bending control fixing component, and the bending control fixing component and the outer sheath tube fixing component are independently connected to the bending adjustment assembly.

[0011] A pull block is provided at the proximal end of the outer flexible tube. The pull block is sleeved on the outer sheath tube and located at the distal end of the outer sheath tube fixing member. Pulling the pull block causes the outer flexible tube to move relative to the outer sheath tube along its axial direction.

[0012] As a preferred embodiment of the present invention, the conveying sleeve further includes an inner liner tube, which is attached to the inner wall of the intermediate tube.

[0013] As one embodiment of the present invention, the conveying device further includes a loading sleeve for binding and squeezing the stitchless support so that its outflow channel is accommodated inside the rear sleeve.

[0014] As a preferred embodiment of the present invention, a guide head is further provided at the distal end of the inner tube, and the guide head is connected to the distal end of the front sleeve.

[0015] In one embodiment of the present invention, a locking member is provided at the distal end of the composite tube, the locking member connecting the intermediate tube and the outer sheath tube; the inflow channel of the sutureless stent is provided with at least two limiting lugs, the locking member is provided with at least two lug grooves, the limiting lugs correspond one-to-one with the lug grooves and are embedded in the lug grooves.

[0016] In one embodiment of the present invention, the distal ends of the intermediate tube and the outer sheath tube are welded, bonded, or riveted.

[0017] As a preferred embodiment of the present invention, the bending assembly includes an end cap, a bending control knob, and an adjustment handle that are connected in sequence.

[0018] The end cap is sleeved on the outer periphery of the outer sheath fixing member and close to the proximal end of the pull block of the outer flexible tube. A limiting clip is provided between the end cap and the pull block, and the limiting clip engages with the outer sheath. The bending control knob is sleeved on the intermediate tube and movably connected to the intermediate tube. The adjusting handle is connected to the outer sheath fixing member and the bending control fixing member respectively. A pusher is provided inside the adjusting handle. The pusher is slidably connected to the adjusting handle and is also connected to the proximal end of the inner tube for driving the inner tube to move along its axial direction.

[0019] As a preferred embodiment of the present invention, a bending control slider is provided at the proximal end of the intermediate tube, the outer wall of the bending control slider is provided with an external thread, the inner wall of the bending control knob is provided with an internal thread, and the external thread and the internal thread mesh with each other; the bending control slider is sleeved on the outer periphery of the bending control fixing member, and is detachably connected to the bending control fixing member and the adjusting handle respectively.

[0020] As a preferred embodiment of the present invention, the pushing component includes a push button, a pushing slider, and a limiting block;

[0021] One end of the push button is connected to the push slider, and the other end extends out of the adjustment handle; the push slider is fixedly connected to the inner tube; one end of the limiting block is movably connected to the inner tube, and the other end is slotted to the adjustment handle. Pressing down on the limiting block pushes the push button, causing the push slider to drive the inner tube to move along its axial direction.

[0022] As a preferred embodiment of the present invention, the inner tube is further provided with a first fixing block and a second fixing block, the first fixing block and the second fixing block being located on opposite sides of the limiting block and the pushing slider.

[0023] As a preferred embodiment of the present invention, the adjustment handle comprises a first housing and a second housing connected in sequence.

[0024] The first housing surrounds the outside of the bending control slider and is detachably connected to the bending control slider; the second housing surrounds the outside of the pusher and is slidably connected to the pusher.

[0025] As a preferred embodiment of the present invention, the first housing includes a first inner shell and a second inner shell that are interlocked with each other. The first inner shell and the second inner shell are also connected to the bending control slider and the bending control fixing member respectively by a first pin and a second pin. The first inner shell and the second inner shell are also independently connected to the outer sheath fixing member. Limiting grooves are provided on both the first inner shell and the second inner shell. The bending control slider passes through the limiting groove and engages with the bending control knob.

[0026] The second housing includes a first outer shell and a second outer shell that are interlocked with each other. The first outer shell is provided with a first nut and a second nut, and the second outer shell is provided with a first screw and a second screw. The first screw is connected to the first nut, and the second screw is connected to the second nut.

[0027] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0028] This invention achieves self-locking of the stent by binding the sutureless stent with the anterior sleeve at the distal end of the inner tube and the posterior sleeve at the distal end of the outer tube. In conjunction with the bending adjustment component, it enables rapid and precise implantation of surgical valves without the need for manual suturing, greatly simplifying the surgical procedure, optimizing the effective opening area of ​​the valve, avoiding paravalvular leakage, reducing surgical risks, and improving the clinical outcomes of surgical valve surgery. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of the biological valve provided by the present invention.

[0030] Figure 2 A schematic diagram of the delivery device for the sutureless valve stent provided by the present invention.

[0031] Figure 3 An exploded view of the delivery device for the sutureless valve stent provided by the present invention.

[0032] Figure 4 This is a schematic diagram of the sutureless stent provided by the present invention.

[0033] Figure 5 This is a schematic diagram of the structure of the front sleeve provided by the present invention.

[0034] Figure 6 This is a schematic diagram of the structure of the rear sleeve provided by the present invention.

[0035] Figure 7 A schematic diagram of the delivery device for a sutureless valve stent with a loading sleeve provided by the present invention.

[0036] Figure 8 This is a schematic diagram of the structure of the lock provided by the present invention.

[0037] Figure 9 This is a structural schematic diagram of the bending control fastener provided by the present invention.

[0038] Figure 10 This is a schematic diagram of the structure of the outer sheath fixing component provided by the present invention.

[0039] Figure 11 This is a schematic diagram of the bending control slider provided by the present invention.

[0040] Figure 12 An exploded view of the delivery device for a sutureless valve stent with an inner liner provided by the present invention.

[0041] Figure 13 This is a schematic diagram of the structure of the pull block provided by the present invention.

[0042] Figure 14 This is a schematic diagram of the structure of the limiting card provided by the present invention.

[0043] Figure 15 This is a schematic diagram of the push button provided by the present invention.

[0044] Figure 16 This is a schematic diagram of the push slider provided by the present invention.

[0045] Figure 17 This is a schematic diagram of the structure of the limiting block provided by the present invention.

[0046] Figure 18 A schematic diagram of the structure of the first inner shell provided by the present invention.

[0047] Figure 19 A schematic diagram of the structure of the first outer casing provided by the present invention.

[0048] Among them, 100-guide head; 120-push button; 131-first outer shell; 132-second outer shell; 140-push slider; 150-limiting block; 160-bending control knob; 170-bending control slider; 180-bending control fixing component; 190-outer sheath fixing component; 200-front sleeve; 210-end cap; 220-outer sheath; 230-intermediate tube; 240-inner tube; 300-locking component; 310-loading sleeve; 320-bioprosthetic valve; 40 0-Seamless bracket; 401-Tightening line; 402-Carrier purse; 500-Rear sleeve; 510-Inner liner tube; 600-Outer flexible tube; 700-Pull block; 800-Limiting clip; 111-First pin; 112-Second pin; 901-First inner shell; 902-Second inner shell; 321-First nut; 322-Second nut; 411-First screw; 422-Second screw; 511-First fixing block; 512-Second fixing block. Detailed Implementation

[0049] It should be understood that in the description of this invention, the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. 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 number of indicated technical features. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0050] It should be noted that, in the description of this invention, unless otherwise explicitly specified and limited, the terms "set," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0051] The technical solution of the present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0052] Traditional bioprosthetic valves 320 mimic natural valves, with a trilobal structure, such as... Figure 1 As shown, achieving low-resistance unidirectional blood flow typically relies on manual sutures to fix the bioprosthetic valve 320 to the patient's valve annulus, which prolongs the operation time, increases the burden on cardiopulmonary bypass, and is prone to problems such as paravalvular leakage. Therefore, this invention provides a sutureless valve stent delivery device, such as... Figure 2 and Figure 3 As shown, it includes a sutureless support 400, a delivery sleeve, and a bending adjustment assembly.

[0053] like Figure 4 As shown, the sutureless stent 400 includes an outflow channel and an inflow channel. A purse-string 402 is disposed within the outflow channel to accommodate the bioprosthetic valve 320. A tightening suture 401 passes through the purse-string 402. It should be noted that the sutureless stent 400 containing the bioprosthetic valve 320 enters the patient's valve annulus from its inflow channel side.

[0054] The delivery sleeve has a proximal end and a distal end, and includes an inner tube 240, a composite tube, and an outer flexible tube 600 nested sequentially. A front sleeve 200 is provided at the distal end of the inner tube 240, and the front sleeve 200 is fitted into the inflow channel of the sutureless stent 400. A rear sleeve 500 is provided at the distal end of the outer flexible tube 600, and the rear sleeve 500 is fitted into the outflow channel of the sutureless stent 400, with the outflow channel facing the proximal end. The bending assembly is connected to the proximal ends of the inner tube 240 and the composite tube, respectively, and is used to drive the composite tube to bend and to release the sutureless stent 400. It should be noted that the proximal end refers to the end closer to the operator, and the distal end is the end farther from the operator, i.e., closer to the target location.

[0055] like Figure 5 and Figure 6 As shown, the front sleeve 200 and the rear sleeve 500 have hollow interiors, and are movable relative to the sutureless stent 400, temporarily housing the sutureless stent 400 within their internal spaces. In application, the front sleeve 200 and the rear sleeve 500 are used together to bind the sutureless stent 400 to the distal end of the delivery cannula. After delivery to the target location, the outflow channel of the sutureless stent 400 within the rear sleeve 500 is first released, and then the inflow channel of the sutureless stent 400 within the front sleeve 200 is released using the bending assembly. The bioprosthetic valve 320 is then inserted from the outflow channel side of the sutureless stent 400, the tightening line 401 is tightened and knotted, completing the sutureless implantation process of the sutureless stent 400 and the bioprosthetic valve 320.

[0056] The sutureless stent 400 described in this invention has a mesh-like structure, with the diameter of its outflow channel larger than that of its inflow channel. It can be a flexible metal stent or a shape-memory metal stent. The inflow channel of the sutureless stent 400 is provided with at least two limiting lugs, which restrict it to the distal end of the composite tube. During delivery, it is compressed and bound to the distal end of the delivery sleeve, so that the outflow channel containing the bioprosthetic valve 320 faces the proximal end. The tightening line 401 is threaded circumferentially along the purse-string 402. Pulling the tightening line 401 and knotting it tightens the purse-string 402 and fixes the bioprosthetic valve 320. When the tightening line 401 is released, the purse-string 402 changes from a tightened state to an expanded state, releasing the bioprosthetic valve 320.

[0057] Furthermore, such as Figure 7 As shown, the sutureless valve stent delivery device is also equipped with a loading sleeve 310 for binding and compressing the sutureless stent 400, ensuring that the outflow channel of the sutureless stent 400 is accurately accommodated inside the rear sleeve 500 during assembly. The structure of the loading sleeve 310 matches the contour of the sutureless stent 400 and can have a gradually expanding diameter structure.

[0058] In some embodiments, the front sleeve 200 and the distal end of the inner tube 240 are fixed by welding, bonding or riveting.

[0059] like Figure 3 As shown, a guide head 100 is also provided at the distal end of the inner tube 240. The guide head 100 is connected to the distal end of the front sleeve 200 and plays a guiding and protective role to avoid damage to surrounding tissues.

[0060] In some implementations, such as Figure 3 As shown, the composite tube of this invention includes a middle tube 230 and an outer sheath tube 220 sequentially sleeved together, with the distal end of the middle tube 230 fixedly connected to the distal end of the outer sheath tube 220. Specifically, the distal end of the middle tube 230 and the distal end of the outer sheath tube 220 are welded, bonded, or riveted together.

[0061] Furthermore, the distal end of the composite tube is provided with, as shown in the image below. Figure 8 The locking member 300 shown is connected to the locking member 300 after the intermediate tube 230 is fixedly connected to the distal end of the outer sheath tube 220. Furthermore, the inflow channel of the sutureless support 400 is provided with at least two limiting lugs, and the locking member 300 is provided with at least two lug slots. The limiting lugs correspond one-to-one with the lug slots and are embedded within them.

[0062] The proximal end of the intermediate tube 230 is fixedly provided with, as shown in the example Figure 9 The bending fixing member 180 shown has a proximal end fixed with a... Figure 10 The outer sheath fixing member 190 is shown. Axially, the outer sheath fixing member 190 is located at the distal end of the bending control fixing member 180. The bending control fixing member 180 and the outer sheath fixing member 190 are also independently connected to the bending adjustment assembly.

[0063] As one embodiment, the proximal end of the inner tube 240 is further provided with, for example... Figure 11 The bending control slider 170 shown has an external thread on its outer wall for threaded connection to the bending adjustment component. The bending adjustment component and the bending control slider 170 cooperate to drive the inner tube 240 to move along its axial direction, so as to release the sutureless stent 400 and the bioprosthetic valve 320.

[0064] Specifically, the bending control slider 170 is sleeved on the outer periphery of the bending control fixing member 180, and the bending control fixing member 180 is detachable. During application, after the bending control slider 170 is combined with the bending control fixing member 180, the bending adjustment component drives the bending control slider 170 to move axially along the middle tube 230 towards the proximal end, causing the outer sheath tube 220 to bend and deform under force, so as to transport the front sleeve 200 and the rear sleeve 500 carrying the sutureless support 400 to the target position.

[0065] As one implementation method, such as Figure 12 As shown, the conveying sleeve also includes an inner liner 510, which is attached to the inner wall of the intermediate tube 230 to reduce frictional resistance. The inner liner 510 is made of polytetrafluoroethylene (PTFE).

[0066] In some embodiments, the proximal end of the external flexible tube 600 of the present invention is provided with, as shown in the figure Figure 13 The pull block 700 shown is sleeved on the outer sheath tube 220 and located at the distal end of the outer sheath tube fixing member 190. Pulling the pull block 700 causes the outer flexible tube 600 to move relative to the outer sheath tube 220 along its axial direction.

[0067] In one embodiment, a space is provided between the pull block 700 and the outer sheath fixing member 190 as shown in the figure. Figure 14 The limiting clip 800 shown engages with the outer sheath 220. When the limiting clip 800 is engaged with the outer sheath 220, it restricts the pull block 700, thereby restricting the movement of the outer flexible tube 600. When the limiting clip 800 is removed, pulling the pull block 700 causes the outer flexible tube 600 to move axially along the outer sheath 220. To facilitate removal of the limiting clip 800 by the operator, one end of the limiting clip 800 has a groove whose size matches the outer diameter of the outer sheath 220, and the other end of the limiting clip 800 has a handle.

[0068] In some embodiments, the bending assembly includes an end cap 210, a bending control knob 160, and an adjustment handle that are sequentially connected.

[0069] The end cap 210 is sleeved on the outer periphery of the outer sheath fixing member 190 and close to the proximal end of the pull block 700 of the outer hose 600, so that the limiting clip 800 is located between the end cap 210 and the pull block 700.

[0070] The bending control knob 160 is sleeved on the intermediate tube 230 and movably connected to the bending control slider 170 on the intermediate tube 230. Specifically, the bending control knob 160 has an internal thread, which meshes with the external thread of the bending control slider 170. Rotating the bending control knob 160 drives the bending control slider 170 to move the intermediate tube 230 along its axial direction, thereby causing the outer sheath tube 220 to bend under force.

[0071] The adjusting handle is connected to the outer sheath fixing member 190 of the outer sheath tube 220 and the bending fixing member 180 of the intermediate tube 230, thereby connecting and fixing the adjusting handle to the delivery sleeve. Furthermore, a pusher is provided inside the adjusting handle, which is slidably connected to the adjusting handle and also connected to the proximal end of the inner tube 240. This pusher drives the inner tube 240 to move axially, thereby moving the front sleeve 200 and releasing the inflow channel of the sutureless stent 400.

[0072] Specifically, the push device includes, for example, Figure 15 The push button 120 shown is as follows: Figure 16 The push slider 140 shown is as follows Figure 17 The limiting block 150 is shown. One end of the push button 120 is connected to the push slider 140, and the other end extends out of the adjusting handle. The push slider 140 is fixedly connected to the inner tube 240; one end of the limiting block 150 is movably connected to the inner tube 240, and the other end is slotted to the adjusting handle. Pressing down on the limiting block 150 and then pushing the push button 120 causes the push slider 140 to drive the inner tube 240 to move along its axial direction.

[0073] Specifically, the adjusting handle has a first slot and a second slot. The end of the limiting block 150 away from the inner tube 240 extends out of the first slot, restricting the movement of the push button 120; while the push button 120 extends out of the second slot. The end of the push button 120 near the push slider 140 has a rectangular protrusion with a deep groove. The push slider 140 has a rectangular boss, the outer contour of which matches the inner cavity of the deep groove. When the limiting block 150 is pressed down, the end of the limiting block 150 extending out of the adjusting handle retracts into the adjusting handle. At the same time, the deep groove of the rectangular protrusion engages with the rectangular boss, pushing the push button 120, which in turn moves the push slider 140.

[0074] Furthermore, the inner tube 240 is also provided with, for example, Figure 12 The first fixing block 511 and the second fixing block 512 shown are located on opposite sides of the limiting block 150 and the push slider 140, respectively.

[0075] In one embodiment, the adjustment handle includes a first housing and a second housing that are sequentially connected.

[0076] The first housing surrounds the outside of the bending control slider 170 and is detachably connected to the bending control slider 170; the second housing surrounds the outside of the pusher and is slidably connected to the pusher.

[0077] Furthermore, the first housing includes a first inner shell 901 and a second inner shell 902 that are interlocked, such as... Figure 3 As shown, the first inner shell 901 and the second inner shell 902 are also connected to the bending control slider 170 and the bending control fixing member 180 respectively via the first pin 111 and the second pin 112. The first inner shell 901 and the second inner shell 902 are also independently and fixedly connected to the outer sheath tube fixing member 190, realizing the connection between the adjusting handle and the intermediate tube 230 and the outer sheath tube 220 respectively.

[0078] Specifically, such as Figure 18 As shown, both the first inner shell 901 and the second inner shell 902 have limiting grooves. The bending control slider 170 passes through the limiting groove and engages with the bending control knob 160. The first inner shell 901 and the second inner shell 902 enclose the bending control knob 160 and the end cap 210.

[0079] Additionally, the second housing includes a first outer shell 131 and a second outer shell 132 that are interlocked, such as... Figure 12 and Figure 19 As shown, the first housing 131 is provided with a first nut 321 and a second nut 322, and the second housing 132 is provided with a first screw 411 and a second screw 422. The first screw 411 is connected to the first nut 321, and the second screw 422 is connected to the second nut 322.

[0080] Specifically, both the first outer shell 131 and the second outer shell 132 are provided with a slot one and a slot two. After the first outer shell 131 and the second outer shell 132 are fastened together, the slot one of the first outer shell 131 and the second outer shell 132 is combined to form a first slot, and the end of the limiting block 150 away from the inner tube 240 extends out from the slot. The slot two of the first outer shell 131 and the second outer shell 132 is combined to form a second slot, and the end of the push button 120 away from the push slider 140 extends out from the slot.

[0081] Example 1

[0082] This embodiment provides a sutureless valve stent delivery device, which includes a sutureless stent 400, a delivery cannula, a bending adjustment assembly, and a loading sleeve 310. The sutureless stent 400 includes an outflow channel and an inflow channel. A loading purse 402 is disposed in the outflow channel to accommodate a bioprosthetic valve 320. A tightening line 401 is threaded through the loading purse 402. Three limiting lugs are provided at the distal end of the inflow channel. The delivery cannula has a proximal end and a distal end, and includes an inner tube 240, a middle tube 230, an outer sheath 220, and an outer flexible tube 600 arranged in sequence. A front sleeve 200 is provided at the distal end of the inner tube 240, and the front sleeve 200 is fitted into the inflow channel of the sutureless stent 400. A rear sleeve 500 is provided at the distal end of the outer flexible tube 600, and the rear sleeve 500 is fitted into the outflow channel of the sutureless stent 400, with the outflow channel facing the proximal end. The inner tube 240 is further provided with a guide head 100 at its distal end, which connects to the distal end of the front sleeve 200. A first fixing block 511 and a second fixing block 512 are also provided on one side of the proximal end of the inner tube 240. The distal end of the intermediate tube 230 is fixedly connected to the distal end of the outer sheath tube 220 and is also fixed to the locking member 300. The outer surface of the locking member 300 is provided with three lug grooves. The proximal end of the intermediate tube 230 is provided with a detachably connected bending control fixing member 180 and a bending control slider 170, the outer wall of which is provided with external threads. The proximal end of the outer sheath tube 220 is provided with an outer sheath tube fixing member 190, which is located distal to the bending control fixing member 180 in the axial direction of the delivery sleeve. The proximal end of the outer flexible tube 600 is provided with a pull block 700, which is sleeved on the outer sheath tube 220 and located distal to the outer sheath tube fixing member 190. The bending assembly includes an end cap 210, a bending control knob 160, and an adjusting handle that are sequentially connected. The end cap 210 is fitted around the outer periphery of the outer sheath fixing member 190 and is located near the proximal end of the pull block 700 of the outer flexible tube 600, with a limiting clip 800 between the end cap 210 and the pull block 700. The bending control knob 160 is fitted onto the intermediate tube 230, and the inner wall of the bending control knob 160 is provided with internal threads. The adjusting handle includes a first housing and a second housing that are sequentially connected, and a pusher located within the second housing. The first housing includes a first inner housing 901 and a second inner housing 902 that are interlocked with each other. The first inner housing 901 and the second inner housing 902 are also connected to the bending control slider 170 and the bending control fixing member 180 respectively via a first pin 111 and a second pin 112, and the first inner housing 901 and the second inner housing 902 are also connected to the outer sheath fixing member 190. Both the first inner shell 901 and the second inner shell 902 have limit grooves, the positions of which correspond to the external threads of the bending control slider 170. The second shell includes a first outer shell 131 and a second outer shell 132 that are interlocked. The first outer shell 131 is provided with a first nut 321 and a second nut 322, and the second outer shell 132 is provided with a first screw 411 and a second screw 422. The first screw 411 is connected to the first nut 321, and the second screw 422 is connected to the second nut 322.The first outer shell 131 and the second outer shell 132 each have slots, which, when fastened together, form a rectangular slot. The pushing component includes a push button 120, a push slider 140, and a limiting block 150. One end of the push button 120 engages with the push slider 140, and the other end extends out of the second shell through the slot. The push slider 140 is fixedly connected to the area between the first fixing block 511 and the second fixing block 512 of the inner tube 240. One end of the limiting block 150 is movably connected to the inner tube 240, and the other end is slotted into the second shell.

[0083] The assembly process of this embodiment includes: connecting the guide head 100 to the distal end of the front sleeve 200; fixing the distal ends of the front sleeve 200 and the inner tube 240 by welding; and connecting and fixing the proximal end of the inner tube 240 to the push slider 140. After the distal ends of the intermediate tube 230 and the outer sheath 220 are connected and fixed by welding, they are then connected and fixed to the locking member 300. The proximal end of the intermediate tube 230 is connected and fixed to the bending control fixing member 180, and then the bending control fixing member 180 and the bending control slider 170 are combined by the first pin 111 and the second pin 112. The proximal end of the outer sheath 220 is connected and fixed to the outer sheath fixing member 190, and then connected and fixed to the first inner shell 901 and the second inner shell 902 respectively, so that the external thread portion of the bending control slider 170 passes through the limiting grooves of the first inner shell 901 and the second inner shell 902 respectively. The end cap 210 is connected and fixed by fitting the distal ends of the first inner shell 901 and the second inner shell 902. The bending control knob 160, with its internal thread, engages with the external thread of the bending control slider 170. The limiting block 150 is connected to the first outer shell 131 and the second outer shell 132 through slots. The push button 120 engages with the rectangular feature at the upper end of the push slider 140 and is enclosed in the cavity after being assembled by the first outer shell 131 and the second outer shell 132. The first outer shell 131 and the second outer shell 132 are locked and closed by the first nut 321, the second nut 322, the first screw 411, and the second screw 422, respectively. The rear sleeve 500 is fixed to the distal end of the outer hose 600, the pull block 700 is fixed to the proximal end of the outer hose 600, and the limiting clip 800 engages with the surface of the outer sheath 220 and is close to the distal end of the end cap 210. The inflow channel of the sutureless bracket 400 has three limiting lugs, which can be connected to the three lug slots on the surface of the lock 300 respectively. The inflow channel of the sutureless bracket 400 is accommodated inside the front sleeve 200, and the outflow channel is accommodated inside the rear sleeve 500 after being constrained and squeezed by the loading sleeve 310.

[0084] Example 2

[0085] This embodiment provides a sutureless valve stent delivery device, which differs from Embodiment 1 in that it also includes an inner liner tube 510, and the inner liner tube 510 is attached to the inner wall of the intermediate tube 230 to reduce frictional resistance. The rest of the structure is the same as that of Embodiment 1.

[0086] Application examples

[0087] This application example utilizes the sutureless valve stent delivery device of Example 1 for the implantation of a bioprosthetic valve. The specific process includes: rotating the bending control knob 160 clockwise, driving the bending control slider 170 connected to the intermediate tube 230 to move axially towards the proximal end, causing the outer sheath tube 220 to bend and deform under force, delivering the front sleeve 200 and the rear sleeve 500 carrying the sutureless stent 400 to the target position, then removing the limiting clip 800, pulling the pull block 700, causing the rear sleeve 500 to move axially towards the proximal end under force, so that the outflow tract side of the sutureless stent 400 is released and opened. Continue advancing the delivery device until the outflow tract side of the sutureless stent 400 reaches the aortic valve annulus. Press the limiting block 150 and push the push button 120 forward. The front sleeve 200 is driven to move axially towards the distal end, allowing the inflow tract of the sutureless stent 400 to be released. Withdraw the delivery device; the sutureless stent 400 is successfully released and fixed in the target position. The tightening suture 401 of the sutureless stent 400 passes through the interior of the purse-string 402. Insert the bioprosthetic valve 320 from the outflow tract side of the sutureless stent 400, tighten the tightening suture 401 and tie a knot, completing the implantation of the sutureless stent and valve.

[0088] The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention, and various simple modifications can be made to the technical solution of the present invention within the scope of the technical concept of the present invention, all of which fall within the scope of protection of the present invention.

Claims

1. A sutureless valve stent delivery device, characterized in that, Includes sutureless support, delivery sleeve, and bending adjustment assembly; The sutureless stent includes an outflow channel and an inflow channel. The outflow channel is provided with a purse-string to accommodate a bioprosthetic valve. A tightening suture is threaded onto the purse-string. The delivery sleeve has a proximal end and a distal end. The delivery sleeve includes an inner tube, a composite tube, and an outer flexible tube nested in sequence. A front sleeve is provided at the distal end of the inner tube. The front sleeve is fitted into the inflow channel of the sutureless stent. A rear sleeve is provided at the distal end of the outer flexible tube. The rear sleeve is fitted into the outflow channel of the sutureless stent. The outflow channel faces the proximal end. The bending assembly is connected to the proximal ends of the inner tube and the composite tube, respectively, and is used to drive the composite tube to bend and release the sutureless stent.

2. The sutureless valve stent delivery device according to claim 1, characterized in that, The composite tube includes an intermediate tube and an outer sheath tube that are sequentially nested together; The distal end of the intermediate tube is fixedly connected to the distal end of the outer sheath tube. The proximal end of the intermediate tube and the proximal end of the outer sheath tube are respectively provided with a bending control fixing component and an outer sheath tube fixing component. The outer sheath tube fixing component is located at the distal end of the bending control fixing component, and the bending control fixing component and the outer sheath tube fixing component are independently connected to the bending adjustment assembly. A pull block is provided at the proximal end of the outer flexible tube. The pull block is sleeved on the outer sheath tube and located at the distal end of the outer sheath tube fixing member. Pulling the pull block causes the outer flexible tube to move relative to the outer sheath tube along its axial direction.

3. The sutureless valve stent delivery device according to claim 2, characterized in that, The conveying sleeve also includes an inner liner, which is attached to the inner wall of the intermediate tube. And / or, the delivery device further includes a loading sleeve for restraining and compressing the sutureless support so that its outlet is received inside the rear sleeve.

4. The sutureless valve stent delivery device according to claim 2, characterized in that, The inner tube is further provided with a guide head at its distal end, and the guide head is connected to the distal end of the front sleeve; And / or, the distal end of the composite tube is provided with a locking member, the locking member connects the intermediate tube and the outer sheath tube, and the inflow channel of the sutureless stent is provided with at least two limiting lugs, the locking member is provided with at least two lug slots, the limiting lugs correspond one-to-one with the lug slots and are embedded in the lug slots; And / or, the intermediate tube is welded, bonded or riveted to the distal end of the outer sheath tube.

5. The delivery device for the sutureless valve stent according to any one of claims 2-4, characterized in that, The bending assembly includes an end cap, a bending control knob, and an adjustment handle that are connected in sequence. The end cap is sleeved on the outer periphery of the outer sheath tube fixing member and close to the proximal end of the pull block of the outer flexible tube, and a limiting clip is provided between the end cap and the pull block, the limiting clip engaging the outer sheath tube; The bending control knob is sleeved on the intermediate tube and is movably connected to the intermediate tube; The adjusting handle is connected to the outer sheath fixing member and the bending control fixing member respectively, and a pusher is provided inside the adjusting handle. The pusher is slidably connected to the adjusting handle and is also connected to the proximal end of the inner tube for driving the inner tube to move along its axial direction.

6. The sutureless valve stent delivery device according to claim 5, characterized in that, The intermediate tube is provided with a bending control slider at its proximal end. The outer wall of the bending control slider is provided with an external thread, and the inner wall of the bending control knob is provided with an internal thread. The external thread and the internal thread mesh with each other. The bending control slider is sleeved on the outer periphery of the bending control fixing member and is detachably connected to the bending control fixing member and the adjusting handle, respectively.

7. The sutureless valve stent delivery device according to claim 6, characterized in that, The pusher includes a push button, a push slider, and a limit block; One end of the push button is connected to the push slider, and the other end extends out of the adjustment handle; The push slider sleeve is fixedly connected to the inner tube; One end of the limiting block is movably connected to the inner tube, and the other end is slotted to the adjusting handle. Pressing down on the limiting block pushes the push button, causing the push slider to move the inner tube along its axial direction.

8. The sutureless valve stent delivery device according to claim 7, characterized in that, The inner tube is also provided with a first fixing block and a second fixing block, which are located on opposite sides of the limiting block and the pushing slider, respectively.

9. The delivery device for the sutureless valve stent according to any one of claims 6-8, characterized in that, The adjustment handle comprises a first housing and a second housing connected in sequence; The first housing surrounds the outside of the bending control slider and is detachably connected to the bending control slider; The second housing surrounds the outside of the pusher and is slidably connected to the pusher.

10. The sutureless valve stent delivery device according to claim 9, characterized in that, The first housing includes a first inner shell and a second inner shell that are interlocked with each other. The first inner shell and the second inner shell are also connected to the bending control slider and the bending control fixing member respectively through a first pin and a second pin. The first inner shell and the second inner shell are also independently connected to the outer sheath fixing member. Both the first inner shell and the second inner shell have limit grooves, and the bending control slider passes through the limit grooves and engages with the bending control knob. The second housing includes a first outer shell and a second outer shell that are interlocked with each other. The first outer shell is provided with a first nut and a second nut, and the second outer shell is provided with a first screw and a second screw. The first screw is connected to the first nut, and the second screw is connected to the second nut.

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