A method for delivering an artificial heart valve and a delivery device

Abstract

The present application discloses a method and a delivery device for delivering an artificial heart valve. The delivery device includes a sheath, a first catheter, and a valve connector. The sheath is provided with at least one circumferential positioning mark, and the sheath is used to accommodate the artificial heart valve, and at least one imaging mark is provided on the artificial heart valve. The first catheter is nested in the inner cavity of the sheath and is in clearance fit with the sheath. The valve connector is sleeved on the first catheter and is used to mount the artificial heart valve and can circumferentially adjust the circumferential position of the artificial heart valve so that the imaging mark of the artificial heart valve is aligned with the circumferential positioning mark of the sheath. By the above method, the present application can perform circumferential positioning of the artificial heart valve by using the sheath with circumferential positioning marks, realize circumferential positioning of the artificial heart valve, and improve the implantation accuracy.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a method and a delivery device for delivering an artificial heart valve. Background Art

[0002] Transcatheter aortic valve replacement is a minimally invasive valve replacement surgery, which refers to implanting an assembled aortic valve into the aortic root through a catheter to replace the original aortic valve and functionally complete the aortic valve replacement.

[0003] Please refer to Figure 1 and Figure 2 , Figure 1 which is a schematic structural diagram of an artificial heart valve, Figure 2 and which is a schematic diagram of the implantation position of the artificial heart valve. Currently, transcatheter implantable aortic valves generally include a valve stent and a valve fixed on the valve stent. The valve includes a circumferential skirt and a junction. The junction is a connecting structure between the valve and the valve stent in the circumferential direction. Generally, the valve is fixed on the valve stent by suture, press fit, bonding or other methods. There are generally three junctions 101 between the valve and the valve stent, and the three junctions 101 are distributed at 120° in the circumferential direction. The junction 101 is generally in the shape of a rhombic sheet. If the junction 101 blocks the coronary artery opening during implantation, it is likely to cause insufficient self-blood supply to the patient's heart and endanger life. Currently, the transcatheter aortic valve delivery method cannot achieve the circumferential positioning of the valve, so it is impossible to determine whether the junction 101 avoids the coronary artery opening, and the situation of coronary artery orifice blockage is likely to occur, which limits the application of transcatheter aortic valve replacement. Summary of the Invention

[0004] The main technical problem to be solved by this application is to provide a method and a delivery device for delivering an artificial heart valve, which can achieve the circumferential positioning of the artificial heart valve and improve the implantation accuracy.

[0005] To solve the above technical problem, one technical solution adopted by this application is: to provide a delivery device for delivering an artificial heart valve, the delivery device includes a sheath, a first catheter, and a valve connector; the sheath is provided with at least one circumferential positioning mark, and the sheath is used to accommodate the artificial heart valve, and at least one imaging mark is provided on the artificial heart valve; the first catheter is nested in the inner cavity of the sheath and is in clearance fit with the sheath; the valve connector is sleeved on the first catheter and is used to mount the artificial heart valve and can circumferentially adjust the circumferential position of the artificial heart valve so that the imaging mark of the artificial heart valve is aligned with the circumferential positioning mark of the sheath; wherein, the sheath can drive the accommodated artificial heart valve, the first catheter, and the valve connector to move circumferentially as a whole, so as to circumferentially position the artificial heart valve by using the sheath with the circumferential positioning mark, and further make the junction of the artificial heart valve avoid the coronary artery opening, and the junction is the connecting part between the valve skirt and the valve stent.

[0006] Among them, the valve connecting piece includes a fixing ring and a connecting ring. The connecting ring is used to mount the artificial heart valve, and the connecting ring is in clearance fit with the first catheter and can move circumferentially relative to the first catheter to circumferentially adjust the circumferential position of the artificial heart valve mounted on the connecting ring, so as to align the imaging mark of the artificial heart valve with the circumferential positioning mark of the sheath tube; The fixing ring is in fastening fit with the first catheter and is used to fix the connecting ring mounted with the artificial heart valve and adjusted to the circumferential position of the artificial heart valve on the first catheter.

[0007] Among them, the circumferential positioning mark is a marking line extending along the axial direction of the sheath tube.

[0008] Among them, the delivery device further includes a guiding head, which is fixedly connected to the first catheter and is in clearance fit with the sheath tube; The guiding head and the first catheter can move axially relative to the sheath tube to realize the loading / release of the artificial heart valve.

[0009] Among them, the delivery device further includes a handle and a second catheter. The sheath tube is fixedly fitted with the handle through the second catheter to drive the sheath tube to move circumferentially and axially by using the handle.

[0010] Among them, an angular positioning mark is arranged on the handle, and the angular positioning mark corresponds to the circumferential positioning mark of the sheath tube. The angular positioning mark is used to mark the angle where the circumferential positioning mark is located.

[0011] Among them, the handle includes a rotating part, and the rotating part is connected to the sheath tube through a tee joint. The rotating part can drive the sheath tube to move axially to realize the loading / release of the artificial heart valve.

[0012] To solve the above technical problems, another technical solution adopted by this application is: to provide a method for delivering an artificial heart valve, which includes providing a delivery device and an artificial heart valve. The delivery device includes a sheath tube and a valve connecting piece. At least one circumferential positioning mark is arranged on the sheath tube, and at least one imaging mark is arranged on the artificial heart valve; Mount the artificial heart valve on the valve connecting piece; Circumferentially adjust the circumferential position of the artificial heart valve so that the imaging mark of the artificial heart valve aligns with the circumferential positioning mark of the sheath tube; Drive the sheath tube to move axially to accommodate the artificial heart valve and the valve connecting piece in the inner cavity of the sheath tube; Circumferentially adjust the circumferential position of the sheath tube so that the joint part of the artificial heart valve avoids the coronary artery opening, and the joint part is the connecting part between the valve skirt and the valve stent.

[0013] Among them, the imaging mark and the joint part are not on the same straight line axially. Circumferentially adjusting the circumferential position of the sheath tube so that the joint part of the artificial heart valve avoids the coronary artery opening includes: adjusting the circumferential angle of the sheath tube until the circumferential positioning mark aligns with any coronary artery opening.

[0014] Among them, adjusting the circumferential position of the circumferential adjustment sheath tube so that the joint of the artificial heart valve avoids the coronary artery opening includes: rotating the handle of the delivery device as a whole so that the handle drives the sheath tube to move circumferentially to adjust the circumferential position of the sheath tube; driving the sheath tube to move axially includes: rotating the rotating part on the handle of the delivery device to drive the sheath tube to move axially to realize the loading / release of the artificial heart valve.

[0015] The beneficial effects of this application are as follows: Different from the prior art, this application determines the angular relationship with the delivery device during the loading process by setting circumferential positioning marks on the artificial heart valve; at the same time, circumferential positioning marks are set on the sheath tube, and the position relationship between the developed positioning marks and the coronary artery opening of the human body can be determined after interventional treatment of the human body in combination with angiography technology, so as to indirectly confirm the position relationship between the valve joint and the coronary artery opening; furthermore, the connecting piece used to connect the valve and the delivery device in this application has the function of circumferential rotation, which can align the positioning marks on the valve and the positioning marks on the sheath tube during the valve loading process, so as to accurately control the implantation angle on the circumference of the valve, that is, the joint can be avoided from the coronary artery opening. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a schematic structural diagram of an artificial heart valve;

[0017] Figure 2 is a schematic diagram of the implantation position of the artificial heart valve;

[0018] Figure 3 is a schematic structural diagram of an artificial heart valve in an embodiment of this application;

[0019] Figure 4 is a schematic structural diagram of a delivery device for delivering an artificial heart valve in an embodiment of this application;

[0020] Figure 5 is a schematic structural diagram of the handle of a delivery device for delivering an artificial heart valve in an embodiment of this application;

[0021] Figure 6 is a schematic diagram of the positional relationship between the Tip tube and the sheath tube when the handle is closed in an embodiment of this application;

[0022] Figure 7 is a schematic diagram of the positional relationship between the Tip tube and the sheath tube when the handle is released in an embodiment of this application;

[0023] Figure 8 is an enlarged view of area D of a delivery device for delivering an artificial heart valve in an embodiment of this application;

[0024] Figure 9 is a schematic diagram of the state of a delivery device for delivering an artificial heart valve after loading the valve in an embodiment of this application;

[0025] Figure 10 It is another schematic diagram of a state after a delivery device for delivering an artificial heart valve loads the valve in an embodiment of the present application;

[0026] Figure 11 It is an enlarged view of region E of a delivery device for delivering an artificial heart valve in an embodiment of the present application;

[0027] Figure 12 It is a schematic flow diagram of a method for delivering an artificial heart valve in an embodiment of the present application;

[0028] Figure 13 It is a state diagram of delivering an artificial heart valve in an embodiment of the present application;

[0029] Figure 14 It is another state diagram of delivering an artificial heart valve in an embodiment of the present application;

[0030] Figure 15 It is a diagram of the implantation position of an artificial heart valve in an embodiment of the present application. Detailed Embodiment

[0031] To make the purpose, technical solutions and effects of the present application clearer and more definite, the following further elaborates on the present application with reference to the accompanying drawings and by way of examples.

[0032] The present application provides a delivery device for delivering an artificial heart valve. A circumferential positioning mark is provided on the sheath of the delivery device, and the valve connecting member of the delivery device can circumferentially adjust the circumferential position of the artificial heart valve. When using this delivery device to deliver an artificial heart valve, the imaging mark of the artificial heart valve can be aligned with the circumferential positioning mark of the sheath by adjusting the valve connecting member, so as to achieve the circumferential positioning of the artificial heart valve by using the sheath with the circumferential positioning mark. Specifically, the sheath can drive the accommodated artificial heart valve to perform circumferential movement to adjust the circumferential position of the artificial heart valve, which can improve the accuracy of the release and positioning of the artificial heart valve. Further, the junction of the artificial heart valve can be avoided from the coronary artery opening.

[0033] Please refer to Figure 3 , Figure 3 It is a schematic structural diagram of an artificial heart valve in an embodiment of the present application. In this embodiment, the artificial heart valve 10 includes a valve stent 110 and a valve. The valve includes valve leaflets (not shown in the figure) and a circumferential skirt 122. The skirt 122 is used to fix the valve leaflets on the valve stent 110, and generally, the valve is fixed on the valve stent 110 by suturing.

[0034] The valve stent 110 can be a self-expanding stent, a balloon-expandable stent, etc. The self-expanding stent can be made of a superelastic alloy and / or a shape memory alloy material, and the balloon-expandable stent can be made of a stainless steel material; the valve stent 110 can be prepared by laser cutting. The valve leaflets can be made of bovine pericardium and porcine pericardium. The skirt 122 can be made of a polymer material.

[0035] The valve further includes a junction 123. The junction 123 is a connecting structure between the valve and the valve stent 110 in the circumferential direction. There are generally three junctions 123, and the three junctions 123 are distributed at 120° in the circumferential direction. When implanting an artificial heart valve, the position where the junction 123 is located is approximately at the same height as the coronary artery opening. At this time, if the junction 123 blocks the coronary artery opening, it is likely to cause insufficient self-blood supply to the patient's heart and endanger life. Therefore, precise circumferential alignment of the artificial heart valve is required in the circumferential direction so that all junctions 123 avoid the coronary artery opening, thereby improving the surgical success rate, accelerating the patient's postoperative recovery, and not affecting the implantation of a coronary stent in the later stage, with high safety and increasing the patient's survival rate.

[0036] In the present application, in order to achieve the circumferential positioning of the artificial heart valve, a visualization marker 130 is provided on the artificial heart valve 10. The visualization marker 130 is discontinuous in the circumferential direction, or in other words, in the circumferential direction, the visualization marker 130 is discrete points / lines for achieving the circumferential positioning function. The visualization marker 130 can be one or more, and multiple visualization markers 130 can be set at different positions of the artificial heart valve 10. As Figure 3 shown, two visualization markers 130 are located on a straight line in the axial direction, facilitating circumferential positioning of different position points in terms of depth.

[0037] In one embodiment, the visualization marker 130 can be distributed on the angular bisector of two junctions 123. Through this setting, during implantation, the position of the artificial heart valve can be adjusted to align the visualization marker 130 with the coronary artery opening, and thus the junction 123 can be avoided from blocking the coronary artery opening. Further, visualization markers 130 can be provided on adjacent two angular bisectors respectively corresponding to the coronary artery openings on both sides, so that all junctions 123 avoid the coronary artery opening. The visualization marker 130 can be a suture with a visualization function or a precious metal material that can be visualized on the valve stent body by using winding and inlaying processes, such as platinum, tantalum, etc. In other embodiments, it can also be set such that the visualization marker 130 and the junction 123 are on a straight line in the axial direction. For example, a visualization material can be directly used for suturing, and the junction 123 can be made with a visualization mark, which is not limited herein.

[0038] Please refer to Figure 4 , Figure 4It is a schematic structural diagram of a delivery device for delivering an artificial heart valve in an embodiment of the present application. In this embodiment, the delivery device 20 includes a Tip tube 210, a sheath tube 220, an inner catheter (not shown in the figure), an outer catheter 230, and a handle 240.

[0039] The handle 240 is mainly used to control the loading, positioning, and release of the valve. The main material is a polymer material, such as polycarbonate, acrylonitrile-butadiene-styrene copolymer, polyoxymethylene resin, polytetrafluoroethylene, etc. The main processing methods are injection molding or machining.

[0040] Please refer to Figure 5 , Figure 5 It is a schematic structural diagram of the handle of a delivery device for delivering an artificial heart valve in an embodiment of the present application. In one embodiment, the handle 240 includes a front-end connector, a three-way ferrule 242, a button 243, a rotating member, a screw 245, a rear-end ferrule 246, a rear-end connector 247, a stress diffusion tube 248, and a one-way valve 249, etc. Among them, the handle 240 is generally cylindrical, and its multiple components are formed by the interlocking of two symmetrical parts. For example, the front-end connector includes two interlocking front-end connecting pieces 2411 and 2412, the rotating member includes two interlocking rotating pieces 2441 and 2442, and the screw 245 includes two interlocking screw pieces (not shown in the figure), etc.

[0041] By rotating the rotating member, the sheath tube 220 connected thereto can be driven to move axially to achieve the loading / release of the valve. Specifically, the handle 240 further includes a three-way assembly and a base assembly. The three-way assembly includes a three-way part (not shown in the figure), a three-way positioning part (not shown in the figure), and a three-way ferrule 242; the three-way part is first limited in the long groove formed by the two screw pieces through the combination of the two screw pieces, and then finally assembled on the screw 245 through the interlocking of the three-way positioning part and the three-way ferrule 242. The three-way assembly can move back and forth axially on the screw 245. The base assembly includes a base (not shown in the figure), a spring (not shown in the figure), and two threaded cards (not shown in the figure); the spring is sleeved on the base, the two threaded cards are installed in the card slots of the base, the button 243 is sleeved on the base, the base is sleeved on the screw 245, and the parts are all in clearance fit; when the button 243 is opened or closed, the threaded cards form a threaded engagement or disengagement state with the screw 245 due to the lever principle. The function of the threaded cards can be understood as a clutch function to control whether the rotating member is allowed to drive the three-way assembly to move. The rotating pieces 2441 and 2442 are interlocked to wrap and fix the base assembly inside, and the three-way assembly follows the rotation of the rotating member to move linearly axially on the screw 245, thereby driving the sheath tube 220 connected to the three-way assembly to move axially to achieve the loading / release of the valve.

[0042] The outer catheter 230 (which can also be called the second catheter) is used to connect the handle 240 and the sheath 220. Specifically, the outer catheter 230 is adhered to the stress diffusion tube 248, the one-way valve 249 is adhesively combined with the stress diffusion tube 248, and the one-way valve 249 is further adhesively combined with the three-way fitting, enabling the outer catheter 230 to rotate with the rotation of the three-way fitting. An O-ring and a plug are also provided in the stress diffusion tube 248 to seal the pipeline. The front end connecting pieces 2411 and 2412 are buckled with each other to fix the stress diffusion tube 248 on the screw 245. The outer catheter 230 has a certain flexibility, can provide the effective working length of the delivery device, and ensure that the valve is positioned in the designated area. The material is a polymer pipe or a composite pipe composed of a polymer and a metal cutting pipe. The polymer material can be nylon elastomer (also known as polyether block amide), nylon, polytetrafluoroethylene, etc., and the metal material can be 304 stainless steel (SUS304), nitinol, etc. The main processing methods are extrusion or hot melt molding.

[0043] The sheath 220 is used to house the artificial heart valve. The sheath 220 can be processed by combining polymer materials, polymer and metal braided wires, or polymer and metal cutting brackets. The polymer material can be polyether block amide, nylon, polytetrafluoroethylene, etc., and the metal material can be SUS304, nitinol, etc. The main processing methods are extrusion or hot melt molding.

[0044] The inner catheter 250 (which can also be called the first catheter) is nested in the inner cavity of the sheath 220 and has a clearance fit with the sheath 220. The two can move axially independently of each other. The inner catheter 250 can help provide the overall mechanical properties of the catheter part of the delivery device. The material is composed of metal or polymer pipes. The processing method is that the metal pipe is cut to form a pipe with appropriate flexibility or a pipe with appropriate flexibility is formed by hot melting polymer materials such as polyether block amide, nylon, and polytetrafluoroethylene.

[0045] The Tip tube 210 (which can also be called the guide head) is fixedly connected to the inner catheter 250, for example, it can be adhesively bonded with glue. The combined length of the Tip tube 210 and the inner catheter 250 can extend all the way to the inside of the handle and be adhesively bonded to the rear end connecting piece 247. The rear end connecting piece 247 is fixed through the groove on the screw 245. When the two screw pieces are combined, the final fixation can be achieved by buckling the rear end snap ring and the rear end socket 246 with each other. The Tip tube 210 plays a role in guiding and protecting blood vessels during the intervention of the delivery device. The material is a flexible polymer material, such as polyether block amide, nylon, etc. The main processing method is injection molding. The TIP tube 210 and the sheath 220 are assembled in a nested manner, and the TIP tube 210 and the sheath 220 have a clearance fit, and the two can move axially independently of each other.

[0046] The end of the sheath tube 220 is bonded to the tee piece. By rotating the rotating part, the tee piece and the outer catheter 230 and the sheath tube 220 connected to the tee piece can be driven to make axial movements. Figure 6 and Figure 7 , Figure 6 is a schematic diagram of the positional relationship between the Tip tube and the sheath tube when the handle is closed in the embodiment of the present application, Figure 7 Schematic diagram of the positional relationship between the tip tube and the sheath tube when the handle is released in the embodiment of the present application. When the rotating member rotates clockwise, the sheath tube 220 moves toward the distal end until it is completely closed with the tip tube 210, completing the loading of the valve or the resetting of the conveyor when withdrawing. When the rotating member rotates counterclockwise, the sheath tube 220 moves toward the proximal end until the valve can be completely exposed outside the sheath tube, completing the release of the valve.

[0047] See also Figure 8 , Figure 8 It is an enlarged schematic diagram of the D area of ​​a conveyor for conveying an artificial heart valve in an embodiment of the present application. In this embodiment, in order to achieve circumferential positioning of the artificial heart valve, a circumferential positioning mark 221 is set on the sheath 220. The circumferential positioning mark 221 is discontinuous in the circumferential direction, or in other words, the circumferential positioning mark 221 is a discrete point / line in the circumferential direction, so as to achieve the circumferential positioning function. The circumferential positioning mark 221 can be a suture with a developing function or a developable precious metal material such as platinum, tantalum, etc., which is wound and inlaid on the sheath body by a winding and inlaying process. The circumferential positioning mark 221 can be one or more, and multiple circumferential positioning marks 221 can be set at different positions of the sheath 220. As shown in FIG. Figure 8 As shown, the circumferential positioning mark 221 can be a marking line extending axially along the sheath tube 220. When the artificial heart valve is loaded on the conveyor, the artificial heart valve is contained in the sheath tube and is stationary relative to the sheath tube. The sheath tube can drive the artificial heart valve to move. Therefore, the positioning mark can be set on the sheath tube to realize the positioning of the artificial heart valve by positioning the sheath tube.

[0048] Please continue reading Figure 8 In one embodiment, the conveyor 20 also includes a valve connector 260 for mounting an artificial heart valve. The valve connector 260 is sleeved on the inner catheter 250, that is, the inner catheter 250 can provide a connection space for axial fixation of the valve connector 260.

[0049] like Figure 8As shown, the valve connector 260 includes a locking ring 261 (which can also be called a fixing ring) and a top ring 262 (which can also be called a connecting ring). The top ring 262 is used to mount the artificial heart valve, and circumferentially distributed bosses can be provided thereon for cooperating with the lugs on the artificial heart valve to mount and fix the artificial heart valve. The material of the top ring 262 is mainly metal material, which can be 304 stainless steel, and the processing method is machining. The locking ring 261 is tightly fitted with the inner catheter 250, such as forming a threaded fastening fit, for fixing the top ring 262 with the artificial heart valve 10 mounted thereon to the inner catheter 250, restricting the axial position of the top ring 262, and also providing a pulling force during valve loading. The material of the locking ring 261 is metal or polymer material, and the processing methods are mainly machining or injection molding.

[0050] In this embodiment, to achieve the circumferential positioning of the artificial heart valve, the top ring 262 is arranged to be able to move circumferentially relative to the inner catheter 250, and the circumferential position of the artificial heart valve mounted on the top ring 262 can be adjusted circumferentially. Specifically, the top ring 262 is in clearance fit with the inner catheter 250 and can rotate freely around the inner catheter 250 to preset the angular position when the valve is loaded into the sheath. In other embodiments, the top ring can also rotate around the inner catheter in ways such as damped rotation and locking after rotation.

[0051] In one embodiment, the top ring 262 can be made to move circumferentially around the inner catheter 250, and the circumferential adjustment aligns the imaging mark of the artificial heart valve with the circumferential positioning mark of the sheath. In this way, the position of the valve relative to the sheath can be determined, and double marking can be carried out to improve the positioning accuracy.

[0052] Please refer to Figure 9 and Figure 10 , Figure 9 which are schematic diagrams of the state of a delivery device for delivering an artificial heart valve after loading the valve in an embodiment of the present application, Figure 10 and Figure 10 Figure 9 which are another schematic diagrams of the state of a delivery device for delivering an artificial heart valve after loading the valve in an embodiment of the present application. Mount the lugs of the artificial heart valve on the bosses of the top ring. All 3 lugs need to be mounted on the 3 bosses of the top ring. During loading, the positioning marks on the valve and the positioning marks on the sheath may not be completely aligned (as shown in Figure 9 Figure 9 ), and the circumferential position of the top ring can be manually rotated and adjusted until the valve positioning mark is aligned with the sheath positioning mark. Of course, the valve positioning mark and the sheath positioning mark can also be aligned at the beginning of loading.

[0053] Please refer to Figure 11 , Figure 11It is an enlarged schematic view of region E of a delivery device for delivering an artificial heart valve in an embodiment of the present application. In this embodiment, an angular orientation mark 2410 is provided on the handle 240. The angular orientation mark 2410 corresponds to the circumferential orientation mark 221 of the sheath 220, and the angular orientation mark 2410 is used to identify the angle at which the circumferential orientation mark 221 is located. As Figure 11 shown, the angular orientation mark 2410 can be an arrow identifier. When assembling the sheath 220 and the handle 240, the marking line (circumferential orientation mark) on the sheath can be made to correspond to the angular identifier, that is, making the two in the same straight line axially. In this way, when rotating and adjusting the handle, the angular change of the sheath can be known by observing the angular change of the angular orientation mark 2410, which is convenient for surgical operation.

[0054] In the present application, by providing a circumferential orientation mark on the artificial heart valve, the angular relationship with the delivery device can be determined during the loading process; at the same time, a radiopaque circumferential orientation mark is provided on the sheath, and the positional relationship between the radiopaque orientation mark and the coronary artery opening of the human body can be determined by combining with angiography technology after entering the human body, thereby indirectly confirming the positional relationship between the valve junction and the coronary artery opening; furthermore, the top ring for connecting the valve and the delivery device has a function of circumferential rotation, which can align the positioning mark on the valve with the radiopaque circumferential orientation mark on the sheath during the valve loading process. In summary, the delivery device provided in the present application can accurately control the implantation angle on the circumference of the valve, that is, it can ensure that the junction perfectly avoids the coronary artery opening. Based on this, the present application also provides a method for delivering an artificial heart valve. Please refer to Figure 12 , Figure 12 It is a schematic flow chart of the method for delivering an artificial heart valve in an embodiment of the present application.

[0055] S310: Provide an artificial heart valve and a delivery device.

[0056] Among them, a circumferential orientation mark is provided on the sheath of the delivery device, and the valve connecting member of the delivery device can circumferentially adjust the circumferential position of the artificial heart valve. A radiopaque mark is provided on the artificial heart valve. Under aseptic conditions, ice water below 10 °C can be prepared, and the artificial heart valve can be placed in the ice water until its stent changes from the austenite state to the martensite state for loading.

[0057] S320: Mount the artificial heart valve on the valve connecting member.

[0058] Specifically, the valve lugs of the artificial heart valve are mounted on the top ring bosses of the valve connecting member. All 3 lugs need to be mounted on the 3 bosses of the top ring. At this time, the radiopaque marks on the valve and the circumferential orientation marks on the sheath are not necessarily completely aligned, as Figure 9 shown.

[0059] S330 Circumferentially adjust the circumferential position of the artificial heart valve to align the imaging mark of the artificial heart valve with the circumferential positioning mark of the sheath tube.

[0060] Since the top ring can be rotated circumferentially, the top ring loaded with the valve can be adjusted circumferentially by hand until the positioning mark of the artificial heart valve is completely aligned with the imaging positioning mark of the sheath tube, as Figure 10 shown.

[0061] S340: Drive the sheath tube to move axially to accommodate the artificial heart valve and the valve connector in the inner cavity of the sheath tube.

[0062] Operate the conveyor handle and rotate the rotating part of the handle clockwise to move the sheath tube towards the distal end of the conveyor until the sheath tube is completely closed with the TIP tube. At this time, the artificial heart valve has been completely loaded according to the adjusted angle.

[0063] S350: Circumferentially adjust the circumferential position of the sheath tube to avoid the junction of the artificial heart valve from the coronary artery opening.

[0064] Specifically, after puncture, insert the conveyor through the femoral artery, combine with the angiography technique, and deliver the sheath tube to the designated area; through angiography, observe the angular relationship θ between the imaging positioning mark of the sheath tube and the coronary artery opening, and adjust the circumferential angle of the sheath tube until the circumferential positioning mark is aligned with any coronary artery opening. Among them, the handle can be rotated as a whole to make the entire conveyor handle move circumferentially as a whole, driving the sheath tube to move circumferentially to adjust the circumferential position. As Figure 13 and Figure 14 shown, Figure 13 is the state diagram of delivering the artificial heart valve in the embodiment of the present application, Figure 14 is another state diagram of delivering the artificial heart valve in the embodiment of the present application.

[0065] S360: Keep the circumferential angle of the sheath tube and drive the sheath tube to move axially to release the artificial heart valve.

[0066] Keep the circumferential angle of the sheath tube, operate the handle to rotate counterclockwise to release the valve, complete the precise implantation of the artificial valve, and then withdraw the conveyor to complete the implantation. As Figure 15 shown, Figure 15 is the implantation position diagram of the artificial heart valve in the embodiment of the present application. In this embodiment, through this method, the junction of the artificial heart valve can be completely avoided from the coronary artery opening. The short-term benefit is to improve the surgical success rate and accelerate the postoperative recovery of the patient; the long-term benefit is not to affect the implantation of the coronary stent in the later stage, and the safety is higher.

[0067] In other embodiments, for different patients, the appropriate angle can be adjusted during the valve loading stage to load the delivery device. Then, through the angular markings on the delivery device combined with angiography technology, precise implantation can be achieved to ensure that after the valve is implanted, the junction of the valve can completely avoid the coronary artery opening.

[0068] As described above, by setting circumferential positioning markings on the artificial heart valve, the angular relationship with the delivery device can be determined during the loading process. At the same time, by setting imaging circumferential positioning markings on the sheath, the positional relationship between the imaging positioning markings and the coronary artery opening of the human body can be determined after interventional operation in combination with angiography technology, thereby indirectly confirming the positional relationship between the valve junction and the coronary artery opening. Moreover, the top ring used to connect the valve and the delivery device in this application has the function of circumferential rotation, which can align the positioning markings on the valve with the imaging positioning markings on the sheath during the valve loading process. The implantation angle on the circumference of the valve can be precisely controlled, that is, it can ensure that the junction of the valve perfectly avoids the coronary artery opening. The short-term benefit is to improve the success rate of the operation and accelerate the postoperative recovery of the patient; the long-term benefit is that it does not affect the implantation of coronary stents in the later stage and has higher safety.

[0069] The above are only the embodiments of the present application, and do not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made by using the content of the specification and drawings of the present application, or directly or indirectly applied in other related technical fields, shall be equally included in the patent protection scope of the present application.

Claims

1. A delivery device for delivering an artificial heart valve, characterized in that, Comprising: A sheath tube provided with at least one circumferential positioning mark, the circumferential positioning mark being a marking line extending along the axial direction of the sheath tube, the sheath tube being used for accommodating an artificial heart valve, and at least one developing mark being provided on the artificial heart valve, the developing mark being discontinuous in the circumferential direction; A first catheter nested in the inner cavity of the sheath tube and in clearance fit with the sheath tube; A valve connecting member sleeved on the first catheter and used for mounting the artificial heart valve, the valve connecting member including a connecting ring for mounting the artificial heart valve, and the connecting ring being in clearance fit with the first catheter and capable of circumferentially moving relative to the first catheter to circumferentially adjust the circumferential position of the artificial heart valve mounted on the connecting ring, so that the developing mark of the artificial heart valve aligns with the circumferential positioning mark of the sheath tube; the transporter further includes a handle, and an angular mark is provided on the handle, the angular mark corresponding to the circumferential positioning mark of the sheath tube, and the angular mark being used for marking the angle where the circumferential positioning mark is located; Wherein, the sheath tube can drive the accommodated artificial heart valve, the first catheter and the valve connecting member to move circumferentially as a whole, so as to circumferentially position the artificial heart valve by using the sheath tube with the circumferential positioning mark, and further avoid the coronary artery opening from the joint part of the artificial heart valve, the joint part being the connecting part between the valve skirt and the valve stent, and the developing marks being distributed on the angular bisectors of the two joint parts.

2. The transporter for transporting an artificial heart valve according to claim 1, wherein: The valve connecting member includes a fixing ring which is in fastening fit with the first catheter and is used for fixing the connecting ring which has mounted the artificial heart valve and adjusted the circumferential position of the artificial heart valve on the first catheter.

3. The delivery device for delivering an artificial heart valve according to claim 1, wherein The transporter further includes: A guiding head fixedly connected to the first catheter and in clearance fit with the sheath tube; the guiding head and the first catheter can move axially relative to the sheath tube to realize the loading / release of the artificial heart valve.

4. The delivery device for delivering an artificial heart valve according to claim 3, wherein, The transporter further includes: A second catheter, the sheath tube being fixedly fitted with the handle through the second catheter to drive the sheath tube to move circumferentially and axially by using the handle.

5. The transporter for transporting an artificial heart valve according to claim 4, wherein: The handle includes a rotating member which is connected to the sheath tube through a tee joint, and the rotating member can drive the sheath tube to move axially to realize the loading / release of the artificial heart valve.

6. The delivery device for delivering an artificial heart valve according to claim 1, wherein, The transporter is used for a method of transporting an artificial heart valve, including: Providing the transporter and the artificial heart valve, the transporter including the sheath tube and the valve connecting member, at least one circumferential positioning mark being provided on the sheath tube, and at least one of the developing marks being provided on the artificial heart valve; Mounting the artificial heart valve on the valve connecting member; Circumferentially adjust the circumferential position of the artificial heart valve so that the imaging marker of the artificial heart valve aligns with the circumferential positioning marker of the sheath tube; Drive the sheath tube to move axially to accommodate the artificial heart valve and the valve connecting member in the inner cavity of the sheath tube; Circumferentially adjust the circumferential position of the sheath tube so that the joint part of the artificial heart valve avoids the coronary artery opening, and the joint part is the connecting part of the valve skirt and the valve stent.

7. The delivery device for delivering an artificial heart valve according to claim 6, characterized in that, Axially, the imaging marker and the joint part are not on the same straight line. The circumferentially adjusting the circumferential position of the sheath tube so that the joint part of the artificial heart valve avoids the coronary artery opening includes: Adjust the circumferential angle of the sheath tube until the circumferential positioning marker aligns with any coronary artery opening.

8. The delivery device for delivering an artificial heart valve according to claim 6, wherein The circumferentially adjusting the circumferential position of the sheath tube so that the joint part of the artificial heart valve avoids the coronary artery opening includes: Rotating the handle of the delivery device as a whole so that the handle drives the sheath tube to move circumferentially to adjust the circumferential position of the sheath tube; The driving the sheath tube to move axially includes: Rotating the rotating member on the delivery device handle to drive the sheath tube to move axially to achieve loading / release of the artificial heart valve.

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