Self-forming prosthetic valve annulus delivery apparatus

Abstract

The present application relates to a self-forming prosthetic valve annulus delivery apparatus. An inner delivery catheter (1100) is movably arranged through an inner cavity of an outer delivery catheter (2100). The inner delivery catheter (1100) comprises a first main tube section (1110) and a first bending adjustment tube section (1120). The distal end of the first main tube section (1110) is connected to the proximal end of the first bending adjustment tube section (1120). An inner control wire (1200) is connected to the first bending adjustment tube section (1120). A pushing inner core rod member (3000) is arranged through the inner cavity of the inner delivery catheter (1100).

Description

Self-formable prosthetic annulus delivery device

[0001] Related applications

[0002] The present application claims priority to the Chinese patent application No. 2024118527802, filed on December 16, 2024, entitled “Self-formable prosthetic annulus delivery device”, and simultaneously claims priority to the Chinese patent application No. 2024108629871, filed on June 28, 2024, entitled “Self-formable prosthetic annulus device”, the contents of which are hereby incorporated by reference in their entirety. TECHNICAL FIELD

[0003] The present application relates to the technical field of medical devices, in particular to a self-formable prosthetic annulus delivery device. BACKGROUND

[0004] Cardiovascular diseases include arteriosclerosis, myocardial infarction, stroke, arrhythmia, and valvular diseases, etc. Valvular diseases, including aortic valve, pulmonary valve, mitral valve, and tricuspid valve diseases, are one of the important causes of heart failure, stroke, and other heart attacks. Among them, mitral valve disease is the most common type of all valvular diseases.

[0005] Mitral valve disease mainly includes mitral regurgitation (MR) and mitral stenosis (MS). Mitral regurgitation refers to a phenomenon that any structure of the valve leaflet, annulus, chordae, papillary muscle, or left ventricle is abnormal or dysfunctional, causing the mitral valve orifice to not fully close and blood to flow back to the left atrium. Regurgitation leads to increased blood flow and elevated blood pressure in the left atrium, and elevated blood pressure in the pulmonary vein. Severe regurgitation can cause pulmonary edema, myocardial damage, heart failure, and even death. Mitral stenosis refers to a phenomenon that the mitral valve opening is narrowed, and blood cannot flow from the left atrium to the left ventricle. Insufficient oxygen-rich blood supply leads to fatigue and difficulty breathing. The increased blood retention in the left atrium leads to elevated left atrial pressure and left atrial enlargement, which can also cause pulmonary edema.

[0006] An aging society will bring a huge patient population, and the incidence of various valvular diseases increases with age. The incidence of mitral regurgitation is much higher than that of aortic stenosis, aortic regurgitation, and mitral stenosis. Considering that about half of the patients with mitral regurgitation have high surgical risks due to low cardiac function, multiple comorbidities, and advanced age, a large number of treatment needs have not been met. One of the reasons for the high surgical risk is that the accuracy of the delivery of the prosthetic annulus to the lesion site cannot be guaranteed. SUMMARY

[0007] According to various embodiments of the present application, a self-formable prosthetic valve annulus delivery device is provided.

[0008] A self-formable prosthetic valve annulus delivery device is provided, comprising:

[0009] An outer delivery sheath assembly comprising an outer delivery catheter;

[0010] An inner delivery sheath assembly comprising an inner delivery catheter and an inner control wire, the inner delivery catheter movably disposed in the inner lumen of the outer delivery catheter, the inner delivery catheter comprising a first main tube segment and a first bending tube segment along its axial direction, the distal end of the first main tube segment connected to the proximal end of the first bending tube segment, wherein the first bending tube segment has a bendable function, the inner control wire connected to the first bending tube segment, the inner control wire used to control the active bending of the first bending tube segment;

[0011] A push inner core rod movably disposed in the inner lumen of the inner delivery catheter, the distal end of the push inner core rod used to connect a prosthetic valve annulus, the inner lumen of the inner delivery catheter used to accommodate the prosthetic valve annulus.

[0012] In one embodiment, the first bending tube segment comprises a first unit tube segment and a second unit tube segment, the hardness of the first unit tube segment is less than the hardness of the second unit tube segment, the proximal end of the first unit tube segment connected to the distal end of the second unit tube segment, the proximal end of the second unit tube segment connected to the distal end of the first main tube segment.

[0013] In one embodiment, the inner control wire comprises a first unit wire and a second unit wire, the first unit wire connected to the distal end of the first unit tube segment, the first unit wire used to control the active bending of the first unit tube segment, the second unit wire connected to the distal end of the second unit tube segment, the second unit wire used to control the active bending of the second unit tube segment.

[0014] In one embodiment, the inner delivery catheter further comprises:

[0015] A first transition tube segment, the distal end of the first transition tube segment connected to the proximal end of the first bending tube segment, the proximal end of the first transition tube segment connected to the distal end of the first main tube segment, the distal end of the first main tube segment connected to the proximal end of the first bending tube segment through the first transition tube segment.

[0016] In one embodiment, the hardness of the first transition tube segment is greater than the hardness of the first bending tube segment, and the hardness of the first transition tube segment is less than the hardness of the first main tube segment.

[0017] In one embodiment, the inner delivery sheath assembly comprises:

[0018] a first delivery handle connected with the inner delivery catheter, and the first delivery handle is in control connection with the inner control wire for controlling axial movement of the inner control wire along the inner delivery catheter.

[0019] In one embodiment, the first delivery handle comprises:

[0020] a first guide sleeve, a distal end of the first guide sleeve is connected with a proximal end of the inner delivery catheter, and the first guide sleeve is provided with a first axial guide rail;

[0021] a first guide slide, the first guide slide is movably assembled on the first guide sleeve along the first axial guide rail, and the first guide slide is connected with the inner control wire;

[0022] a first control element, the first control element is screw assembled in the first guide sleeve, wherein the first control element is connected with the first guide slide for controlling movement of the first guide slide along the first axial guide rail relative to the first guide sleeve.

[0023] In one embodiment, the outer delivery sheath assembly further comprises an outer control wire, and the outer delivery catheter comprises a second main tube segment and a second bending tube segment along an axial direction thereof, and a distal end of the second main tube segment is connected with a proximal end of the second bending tube segment.

[0024] In one embodiment, the second bending tube segment has a bendable function, the outer control wire is connected with the second bending tube segment, and the outer control wire is used for controlling active bending of the second bending tube segment.

[0025] In one embodiment, the outer delivery catheter further comprises:

[0026] a second transition tube segment, a distal end of the second transition tube segment is connected with a proximal end of the second bending tube segment, a proximal end of the second transition tube segment is connected with a distal end of the second main tube segment, and the distal end of the second main tube segment is connected with the proximal end of the second bending tube segment through the second transition tube segment.

[0027] In one embodiment, the second transition tube segment has a hardness greater than that of the second bending tube segment, and the second transition tube segment has a hardness less than that of the second main tube segment.

[0028] In one embodiment, the outer delivery sheath assembly comprises:

[0029] a second delivery handle connected with the outer delivery catheter and controlled connection with the outer control wire for controlling axial movement of the outer control wire along the outer delivery catheter.

[0030] In one embodiment, the second delivery handle comprises:

[0031] a second guide sleeve, a distal end of the second guide sleeve connected with a proximal end of the inner delivery catheter, the second guide sleeve provided with a second axial guide rail;

[0032] a second guide slide movably assembled on the second guide sleeve along the second axial guide rail, the second guide slide connected with the inner control wire;

[0033] a second control element screw assembled in the second guide sleeve, wherein the second control element is connected with the second guide slide for controlling movement of the second guide slide along the second axial guide rail relative to the second guide sleeve.

[0034] In one embodiment, the inner delivery catheter comprises a first inner layer tube, a first middle layer tube and a first outer layer tube in the radial direction thereof, the first inner layer tube sleeved in the inner cavity of the first middle layer tube, the first middle layer tube sleeved in the inner cavity of the first outer layer tube.

[0035] In one embodiment, the material of the first inner layer tube comprises at least one of polytetrafluoroethylene and polyimide.

[0036] In one embodiment, the first middle layer tube adopts a stainless steel braided mesh tube or a hypotube.

[0037] In one embodiment, the first outer layer tube adopts a medical polymer tube.

[0038] In one embodiment, the outer delivery catheter comprises a second inner layer tube, a second middle layer tube and a second outer layer tube in the radial direction thereof, the second inner layer tube sleeved in the inner cavity of the second middle layer tube, the second middle layer tube sleeved in the inner cavity of the second outer layer tube.

[0039] In one embodiment, the material of the second inner layer tube comprises at least one of polytetrafluoroethylene and polyimide.

[0040] In one embodiment, the second middle layer tube adopts a stainless steel braided mesh tube or a hypotube.

[0041] In one embodiment, the second outer layer tube adopts a medical polymer tube.

[0042] In one of the embodiments, the artificial valve ring comprises a main core wire, a proximal release structure, a radiopaque member and a distal protection member.

[0043] The main core wire is made of a metal wire with shape memory property, and the main core wire has a helical spring-like structure as a whole, and the portion of the main core wire extending along the Archimedes spiral line outwardly is located at the distal end.

[0044] The proximal release structure is connected to the proximal end of the main core wire.

[0045] The radiopaque member is arranged at the portion of the main core wire extending along the Archimedes spiral line outwardly.

[0046] The distal protection member is arranged at the distal end of the main core wire.

[0047] In one of the embodiments, the main core wire has not less than two turns, and the portion of the main core wire extending along the Archimedes spiral line outwardly is 1 / 4 to 1 / 2 turn at the distal end.

[0048] In one of the embodiments, the main core wire comprises a main segment and a distal grinding segment at the distal end of the main segment, and the distal grinding segment is located at the portion of the main core wire extending along the Archimedes spiral line outwardly.

[0049] In one of the embodiments, the distal grinding segment has a smooth decreasing diameter along the direction towards the distal end, so that the distal grinding segment has an elongated conical shape.

[0050] In one of the embodiments, the radiopaque member comprises a radiopaque spring, and the radiopaque spring is made of a platinum-tungsten alloy, a platinum-iridium alloy or a gold wire which has radiopacity under X-ray or ultrasound.

[0051] In one of the embodiments, the radiopaque spring is welded or glued to the main core wire.

[0052] In one of the embodiments, the distal protection member is woven into a predetermined three-dimensional shape by a metal wire with shape memory property, and the metal wire used for the distal protection member is thinner than the metal wire used for the main core wire.

[0053] In one of the embodiments, the distal protection member has a spherical cage-like or water drop-like structure with a diameter of 2 to 5 mm.

[0054] In one of the embodiments, the proximal release structure is configured to be released from the matched delivery member by any one of mechanical release, electrolytic release and hydrolytic release, and the proximal release structure can be completely accommodated into the matched delivery sheath before being released.

[0055] In one of the embodiments, the proximal release structure comprises a ball, and the end of the delivery member is correspondingly provided with a clamping jaw, and an arc-shaped slot adapted to the ball is formed on the clamping jaw.

[0056] In one of the embodiments, the proximal release structure comprises a tube, and a T-shaped limiting slot is formed on the side wall of the tube, and the end of the delivery member is correspondingly provided with a clamping jaw, and a T-shaped block adapted to the limiting slot is formed on the clamping jaw.

[0057] In one of the embodiments, the proximal release structure comprises a first limiting buckle, and a limiting socket is formed on one side of the first limiting buckle, and the end of the delivery member is correspondingly provided with a second limiting buckle, and a mating socket adapted to the limiting socket is formed on the second limiting buckle.

[0058] In one of the embodiments, the proximal release structure is provided with an internal thread, and the end of the delivery member is correspondingly provided with an external thread, and the proximal release structure and the end of the delivery member are threadedly connected.

[0059] In one of the embodiments, a surface lubricating layer is further included, and the surface lubricating layer uniformly covers the outer surfaces of the main body core wire, the proximal release structure, the developing member and the distal protection member.

[0060] In one of the embodiments, the surface lubricating layer is any one of a medical-grade fluorine-containing material heat-shrinkable tube, a hydrophilic coating and a hydrophobic coating.

[0061] The details of one or more embodiments of the present application are presented in the following drawings and description, and other features, objects and advantages of the present application will become apparent from the description, drawings and claims. BRIEF DESCRIPTION OF DRAWINGS

[0062] In order to more clearly illustrate the technical solutions in the embodiments of the present application or in the prior art, the drawings needed to be used in the following embodiment or prior art description will be briefly introduced. Obviously, the drawings in the following description are only embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative effort on the basis of the disclosed drawings.

[0063] FIG. 1 is a schematic diagram of the overall structure of a self-formable artificial valve ring delivery device according to some embodiments of the present application.

[0064] FIG. 2 is a schematic diagram of the structure of an inner delivery sheath assembly and a pushing inner core rod according to some embodiments of the present application.

[0065] FIG. 3 is a schematic diagram of the structure of an outer delivery sheath assembly according to some embodiments of the present application.

[0066] FIG. 4 is a schematic diagram of the structure of an inner delivery catheter according to some embodiments of the present application.

[0067] Figure 5 is a radial cross-sectional view of an inner delivery sheath assembly according to some embodiments of the present application.

[0068] Figure 6 is an exploded view of an inner delivery sheath assembly according to some embodiments of the present application.

[0069] Figure 7 is a structural view of an outer delivery catheter according to some embodiments of the present application.

[0070] Figure 8 is a radial cross-sectional view of an outer delivery sheath assembly according to some embodiments of the present application.

[0071] Figure 9 is an exploded view of an outer delivery sheath assembly according to some embodiments of the present application.

[0072] Figure 10 is a structural view of a prosthetic annulus according to some embodiments of the present application.

[0073] Figure 11 is a structural view of the prosthetic annulus of Figure 10 from another perspective.

[0074] Figure 12 is a comparative structural view of three detachment forms of a prosthetic annulus using mechanical detachment according to some embodiments of the present application.

[0075] Figure 13 is a schematic view of the cooperation of a prosthetic annulus with a prosthetic valve after release according to some embodiments of the present application.

[0076] Figure 14 is a schematic view of the cooperation of a prosthetic annulus with native leaflets and chordae tendineae after release according to some embodiments of the present application. DETAILED DESCRIPTION

[0077] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of protection of the present application.

[0078] In order to more clearly describe the structure of the self-formable prosthetic annulus delivery device, the term "distal end" is defined herein to mean the end that is far away from the operator during the operation, and the term "proximal end" is defined herein to mean the end that is close to the operator during the operation. Unless otherwise defined, all the technical and scientific terms used in the present application have the same meanings as those commonly understood by those skilled in the art to which the present application belongs. The terms used in the specification of the present application are only for the purpose of describing the embodiments and are not intended to limit the present application.

[0079] Referring to FIGS. 1-3, the present application provides a self-formable artificial annulus delivery device. The self-formable artificial annulus delivery device includes an inner delivery sheath assembly 1000, an outer delivery sheath assembly 2000, and a push inner core rod 3000. As shown in FIGS. 2 and 4, the inner delivery sheath assembly 1000 includes an inner delivery catheter 1100 and an inner control wire 1200, and the outer delivery sheath assembly 2000 includes an outer delivery catheter 2100. The outer diameter of the inner delivery catheter 1100 is slightly smaller than the inner diameter of the outer delivery catheter 2100, and the inner delivery catheter 1100 is movably arranged in the inner cavity of the outer delivery catheter 2100. The inner control wire 1200 can be made of stainless steel wire.

[0080] The push inner core rod 3000 is movably arranged in the inner cavity of the inner delivery catheter 1100, and the distal end of the push inner core rod 3000 is used to connect the artificial annulus 100. The inner cavity of the inner delivery catheter 1100 is used to accommodate the artificial annulus 100. The distal end of the push inner core rod 3000 can be releasably connected to the artificial annulus 100, and the connection mode can be mechanical release, hydrolysis release, thermal release, or electrochemical release.

[0081] The artificial annulus 100 has a deformation ability and can present a contracted state under a stress state, with a reduced volume, and can present an expanded state under a non-stress state, with an increased volume. Therefore, the artificial annulus 100 can be loaded into the inner cavity of the inner delivery catheter 1100 in the contracted state, and then connected by the push inner core rod 3000. The artificial annulus 100 in the contracted state is controlled by the push inner core rod 3000 to move axially in the inner cavity of the inner delivery catheter 1100. When the artificial annulus 100 is controlled by the push inner core rod 3000 to be released from the restraint of the inner delivery catheter 1100, the artificial annulus 100 can be released from the stress and present the expanded state, and is implanted into the target position in the body, i.e., the target lesion position.

[0082] In one embodiment, the inner delivery catheter 1100 includes a first inner layer tube, a first middle layer tube, and a first outer layer tube along the radial direction thereof. The first inner layer tube is sleeved in the inner cavity of the first middle layer tube, and the first middle layer tube is sleeved in the inner cavity of the first outer layer tube. The material of the first inner layer tube includes at least one of polytetrafluoroethylene and polyimide, for example, the first inner layer tube is made of two tubes of polytetrafluoroethylene and polyimide, and is formed by heat rheological composite processing. The first middle layer tube is made of a stainless steel woven mesh tube or a hypotube. The first outer layer tube is made of a medical polymer tube.

[0083] The outer delivery catheter 2100 comprises a second inner layer tube, a second middle layer tube and a second outer layer tube along its radial direction, the second inner layer tube is sleeved in the inner cavity of the second middle layer tube, and the second middle layer tube is sleeved in the inner cavity of the second outer layer tube. The material of the second inner layer tube comprises at least one of polytetrafluoroethylene and polyimide, for example, the second inner layer tube adopts two kinds of tubes of polytetrafluoroethylene and polyimide, and is formed by heat rheological composite processing. The second middle layer tube adopts a stainless steel woven mesh tube or a hypotube. The second outer layer tube adopts a medical polymer tube.

[0084] Continuing to refer to FIG. 4, the inner delivery catheter 1100 comprises a first main tube segment 1110 and a first bending tube segment 1120 along its axial direction (the transverse direction of FIG. 4), the distal end of the first main tube segment 1110 is connected to the proximal end of the first bending tube segment 1120, wherein the first bending tube segment 1120 has a bendable function, and the bendable function of the first bending tube segment 1120 can be realized by special design of the material, hardness, etc. of the first bending tube segment 1120, so that the first bending tube segment 1120 can bend when subjected to a certain range of acting force.

[0085] Therefore, the inner control wire 1200 is connected to the first bending tube segment 1120, and when the inner control wire 1200 is pulled, the inner control wire 1200 can be used to control the active bending of the first bending tube segment 1120, and the bending degree of the first bending tube segment 1120 is adjusted according to the control force of pulling the inner control wire 1200. In one embodiment, the inner control wire 1200 can be connected to different positions of the first bending tube segment 1120 according to requirements, such as different circumferential positions or different axial positions of the first bending tube segment 1120, so that the pulling force of the inner control wire 1200 can be applied to different positions of the first bending tube segment 1120, thereby controlling the first bending tube segment 1120 to bend towards different directions.

[0086] Continuing to refer to FIG. 4, in one embodiment, the first bending tube segment 1120 can comprise a first unit tube segment 1121 and a second unit tube segment 1122, i.e. the first bending tube segment 1120 with a bendable function is further divided into two tube segments with different hardnesses, and the hardness of the first unit tube segment 1121 is limited to be less than the hardness of the second unit tube segment 1122, so that based on the different hardnesses, the first unit tube segment 1121 can bend more easily than the second unit tube segment 1122, and has more flexible bending ability. At this time, the proximal end of the first unit tube segment 1121 is connected to the distal end of the second unit tube segment 1122, and the proximal end of the second unit tube segment 1122 is connected to the distal end of the first main tube segment 1110.

[0087] At this time, the inner control wire 1200 also includes a first unit wire 1201 and a second unit wire 1202, the first unit wire 1201 is connected to the distal end of the first unit pipe segment 1121, and the first unit wire 1201 is used to control the active bending of the first unit pipe segment 1121, the second unit wire 1202 is connected to the distal end of the second unit pipe segment 1122, and the second unit wire 1202 is used to control the active bending of the second unit pipe segment 1122.

[0088] In addition, the first bending pipe segment 1120 can be divided into two or more pipe segments with different hardness according to the needs of the person skilled in the art, and two or more unit wires can be provided at the same time, and each unit wire is used to control the independent bending of a pipe segment to adapt to different bending needs. Among them, the connection position of the first unit wire 1201 or the second unit wire 1202 with the first unit pipe segment 1121 or the second unit pipe segment 1122 can be adjusted according to the needs, so that the first unit pipe segment 1121 and the second unit pipe segment 1122 can be bent towards the same direction or different directions according to the needs, to achieve more flexible bending effect and achieve the expected bending effect. The person skilled in the art can adjust according to the actual needs, which is not limited here.

[0089] In addition, in one embodiment, the inner delivery catheter 1100 further includes a first transition pipe segment 1130, the distal end of the first transition pipe segment 1130 is connected to the proximal end of the first bending pipe segment 1120, and the proximal end of the first transition pipe segment 1130 is connected to the distal end of the first main body pipe segment 1110. The distal end of the first main body pipe segment 1110 is connected to the proximal end of the first bending pipe segment 1120 through the first transition pipe segment 1130, wherein the hardness of the first transition pipe segment 1130 is greater than the hardness of the first bending pipe segment 1120, and the hardness of the first transition pipe segment 1130 is less than the hardness of the first main body pipe segment 1110.

[0090] If the first bending pipe segment 1120 includes the first unit pipe segment 1121 and the second unit pipe segment 1122, then the proximal end of the first transition pipe segment 1130 is connected to the distal end of the first main body pipe segment 1110, and the distal end of the first main body pipe segment 1110 is connected to the proximal end of the second unit pipe segment 1122 of the first bending pipe segment 1120 through the first transition pipe segment 1130. Among them, the hardness of the first unit pipe segment 1121 is less than the hardness of the second unit pipe segment 1122, the hardness of the first transition pipe segment 1130 is greater than the hardness of the second unit pipe segment 1122, and the hardness of the first transition pipe segment 1130 is less than the hardness of the first main body pipe segment 1110.

[0091] In one of the embodiments, the inner delivery sheath assembly 1000 further comprises a first delivery handle 1300, the first delivery handle 1300 is connected with the inner delivery catheter 1100, and the first delivery handle 1300 is in control connection with the inner control wire 1200 for controlling the axial movement of the inner control wire 1200 along the inner delivery catheter 1100. Therefore, the operator can control the inner control wire 1200 by using the first delivery handle 1300, and by applying force to the inner control wire 1200 to make the inner control wire 1200 move axially, and then indirectly apply force to the first bending tube segment 1120 through the inner control wire 1200 to control the active bending of the first bending tube segment 1120.

[0092] When the first bending tube segment 1120 comprises a first unit tube segment 1121 and a second unit tube segment 1122, the first delivery handle 1300 can also independently control the first unit wire 1201 or the second unit wire 1202, and then independently control the active bending of the first unit tube segment 1121 and the second unit tube segment 1122 through the first unit wire 1201 or the second unit wire 1202.

[0093] The first delivery handle 1300 can use any feasible driving mechanism to control the inner control wire 1200, for example, in one of the embodiments, the first delivery handle 1300 can comprise a first guide sleeve 1310, a first guide slide 1320 and a first control element 1330, the distal end of the first guide sleeve 1310 is connected with the proximal end of the inner delivery catheter 1100, the first guide sleeve 1310 is provided with a first axial guide rail, the first guide slide 1320 is movably assembled on the first guide sleeve 1310 along the first axial guide rail, the first guide slide 1320 is connected with the inner control wire 1200, and the first control element 1330 is screwedly assembled on the first guide sleeve 1310.

[0094] The first control element 1330 is connected with the first guide slide 1320, and the first control element 1330 moves axially relative to the first guide sleeve 1310 through screwing movement, when the operator screwingly rotates the first control element 1330 relative to the first guide sleeve 1310, the first control element 1330 can move in a small distance with high precision in the axial direction, and then can be used to control the movement of the first guide slide 1320 relative to the first guide sleeve 1310 along the first axial guide rail, and ensure the movement precision of the first guide slide 1320.

[0095] Continuing to refer to FIGS. 5 and 6, the first delivery handle 1300 can further include a tip element 1340, a first control knob 1350, a second control knob 1360, a first irrigation head 1370, a first sealing end cap 1380, a first handle housing 1390, and the like cooperating structures, all of which in the first delivery handle 1300 can be made of ABS / PC / POM or the like medical polymer injection molding. In one embodiment, two first guide slides 1320 can be provided respectively, and the two first guide slides 1320 are respectively connected to the first unit wire 1201 or the second unit wire 1202, and the two first guide slides 1320 can be arranged at different axial positions of the first guide sleeve 1310 in the axial direction.

[0096] At this time, the first control knob 1350 and the second control knob 1360 can be internally provided with a threaded structure, so that the first control knob 1350 and the second control knob 1360 can be respectively screwed with the two first control elements 1330, for controlling the axial movement of the two first control elements 1330 on the first guide sleeve 1310 by threaded driving. The axial movement of the two first control elements 1330 on the first guide sleeve 1310 can be respectively used to drive the axial movement of the two first guide slides 1320 on the first guide sleeve 1310.

[0097] Among them, the first axial guide rail can adopt a linear protruding structure, the first control knob 1350 and the second control knob 1360 can adopt a sleeve structure with a threaded structure inside, the first control element 1330 and the first guide slide 1320 can adopt a sleeve ring structure, and the first control element 1330 has a threaded structure outside. In addition, continuing to refer to FIGS. 5 and 6, the tip element 1340 can be arranged at the distal end of the first guide sleeve 1310, the first sealing end cap 1380 can be arranged at the proximal end of the first guide sleeve 1310, the first irrigation head 1370 is assembled on the first guide sleeve 1310, which can be used for external irrigation assembly, and the first delivery handle 1300 can further include all the above structures through the detachable first handle housing 1390.

[0098] In one of the embodiments, the outer delivery sheath assembly 2000 further comprises an outer control wire 2200, which can be made of stainless steel wire. The outer delivery catheter 2100 comprises a second main tube segment 2110 and a second bending tube segment 2120 along its axial direction (the transverse direction in FIG. 7), the distal end of the second main tube segment 2110 is connected to the proximal end of the second bending tube segment 2120, wherein the second bending tube segment 2120 has a bendable function, which can be achieved by special design of the material, hardness, etc. of the second bending tube segment 2120, so that the second bending tube segment 2120 can bend when subjected to a certain range of forces.

[0099] Therefore, the outer control wire 2200 is connected to the second bending tube segment 2120, when the outer control wire 2200 is pulled, the outer control wire 2200 can be used to control the active bending of the second bending tube segment 2120, and the bending degree of the second bending tube segment 2120 can be adjusted according to the control force of pulling the outer control wire 2200. In one of the embodiments, the outer control wire 2200 can be connected to different positions of the second bending tube segment 2120 according to needs, for example, connected to different positions in the circumferential direction or different positions in the axial direction of the second bending tube segment 2120, so that the pulling force of the outer control wire 2200 can be applied to different positions of the second bending tube segment 2120, thereby controlling the second bending tube segment 2120 to bend towards different directions.

[0100] In one of the embodiments, the inner control wire 1200 and the outer control wire 2200 can be connected to different positions of the first bending tube segment 1120 and the second bending tube segment 2120 according to needs, so that the first bending tube segment 1120 and the second bending tube segment 2120 can bend towards the same direction or different directions according to needs, to achieve the desired bending effect, which can be adjusted according to actual needs by those skilled in the art, and is not limited herein.

[0101] In addition, in one of the embodiments, the outer delivery catheter 2100 further comprises a second transition tube segment 2130, the distal end of the second transition tube segment 2130 is connected to the proximal end of the second bending tube segment 2120, the proximal end of the second transition tube segment 2130 is connected to the distal end of the second main tube segment 2110, and the distal end of the second main tube segment 2110 is connected to the proximal end of the second bending tube segment 2120 through the second transition tube segment 2130, wherein the hardness of the second transition tube segment 2130 is greater than the hardness of the second bending tube segment 2120, and the hardness of the second transition tube segment 2130 is less than the hardness of the second main tube segment 2110.

[0102] In one of the embodiments, the outer delivery sheath assembly 2000 further comprises a second delivery handle 2300, the second delivery handle 2300 is connected with the outer delivery catheter 2100, and the second delivery handle 2300 is in control connection with the outer control wire 2200, for controlling the axial movement of the outer control wire 2200 along the outer delivery catheter 2100. Therefore, the operator can control the outer control wire 2200 by using the second delivery handle 2300, by applying force to the outer control wire 2200 to make the outer control wire 2200 move axially, and then indirectly apply force to the second bending tube segment 2120 through the outer control wire 2200, to control the active bending of the second bending tube segment 2120.

[0103] The second delivery handle 2300 can use any feasible driving mechanism to control the outer control wire 2200, for example, in one of the embodiments, the second delivery handle 2300 comprises a second guide sleeve 2310, a second guide slide 2320 and a second control element 2330, the distal end of the second guide sleeve 2310 is connected with the proximal end of the inner delivery catheter 1100, the second guide sleeve 2310 is provided with a second axial guide rail, the second guide slide 2320 is movably assembled on the second guide sleeve 2310 along the second axial guide rail, the second guide slide 2320 is connected with the inner control wire 1200, and the second control element 2330 is screwedly assembled on the second guide sleeve 2310.

[0104] Among them, the second control element 2330 is connected with the second guide slide 2320, and the second control element 2330 moves axially relative to the second guide sleeve 2310 through the threaded movement mode, when the operator threadedly rotates the second control element 2330 relative to the second guide sleeve 2310, the second control element 2330 can move in a small distance with high precision in the axial direction, and then can be used to control the movement of the second guide slide 2320 relative to the second guide sleeve 2310 along the second axial guide rail, and ensure the movement precision of the second guide slide 2320.

[0105] With reference to FIGS. 8 and 9, the second delivery handle 2300 can further include a distal end fixing nut 2340, a damping fixing knob 2350, an internally threaded knob 2360, a second handle housing 2370, a second flushing head 2380, a second sealing end cap 2390, and the like cooperating structures, all of which can be made of ABS / PC / POM or other medical polymer by injection molding. In one embodiment, the internally threaded knob 2360 can be internally threaded, so that the internally threaded knob 2360 can be threadedly engaged with the second control element 2330 to control the axial movement of the second control element 2330 on the second guide sleeve 2310 by threaded driving. The axial movement of the second control element 2330 on the second guide sleeve 2310 can drive the axial movement of the second guide slide 2320 on the second guide sleeve 2310.

[0106] In one embodiment, the second axial guide rail can be a linear protrusion, the internally threaded knob 2360 can be a sleeve structure with internal threads, the second control element 2330 and the second guide slide 2320 can be a sleeve ring structure, and the second control element 2330 can have external threads.

[0107] In addition, with reference to FIGS. 8 and 9, the distal end fixing nut 2340 can be disposed at the distal end of the second guide sleeve 2310 to assemble the damping fixing knob 2350 at the distal end of the second guide sleeve 2310, and the damping fixing knob 2350 is assembled with the internally threaded knob 2360. The distal end fixing nut 2340 can tightly engage the damping fixing knob 2350 with the second guide sleeve 2310, and the damping fixing knob 2350 can include a plurality of stainless steel elastic pins corresponding to the circumferentially distributed pin holes on the second guide sleeve 2310. Therefore, when the damping knob is fixed, the second delivery handle 2300 can be rotated to pause the outer delivery sheath assembly 2000 at any angle along the axis. The second sealing end cap 2390 can be disposed at the proximal end of the second guide sleeve 2310, and the second flushing head 2380 can be assembled on the second guide sleeve 2310 to be connected to a flushing assembly. The second delivery handle 2300 can further include all the above-mentioned structures through the detachable second handle housing 2370.

[0108] After the self-forming prosthetic valve ring delivery device is used to deliver the prosthetic valve ring 100 to the target position in the body, the prosthetic valve ring 100 is in an expanded state and positioned at the target position in the body.

[0109] Therefore, the self-forming artificial valve ring delivery device provided has good controllability and delivery performance. The multi-angle spatial control performance effectively improves the success rate of mitral valve replacement surgery, and can meet the needs of mitral valve replacement surgery through various routes such as the femoral artery, the interatrial septum (through the femoral vein), and the heart apex, so that the release path of the artificial valve ring 100 is diverse, and can meet the needs of percutaneous or transapical path, mainly through the transapical path with lower difficulty, greatly improving the operation range, and the operation method is simple and easy to learn, which can effectively reduce the operator's learning curve and operation time.

[0110] Moreover, the release action is simple and easy to operate. After the delivery device reaches the target lesion position, only a pushing or retracting action is needed to realize the winding of the artificial valve ring 100 on the chordae tendineae or valve leaflet, and more than 96% of the length of the artificial valve ring 100 can be recycled, and the number of recycling is not limited, which can effectively improve the success rate of surgery. Moreover, the threaded connection can achieve 100% recycling. (Note: The length of the chordae tendineae is uneven, the shape of the valve ring is irregular, and the space of the ventricle is narrow. Usually, mitral valve replacement surgery is complex and time-consuming, and the success rate is not high.)

[0111] The operator can accurately control the bending shape of the distal end of the inner delivery catheter 1100 or the outer delivery catheter 2100 during the operation according to the needs, which is beneficial to the first bending pipe section 1120 of the inner delivery catheter 1100 to effectively pass through the outside of the native mitral valve leaflet and chordae tendineae, thereby greatly improving the accurate implantation of the self-forming artificial valve ring 100, and greatly improving the success rate of transcatheter mitral valve repair (TMVR). During the operation process, the opening and closing of the mitral valve are not affected, which can greatly reduce the heart load and the probability of postoperative complications such as atrial fibrillation.

[0112] As shown in FIGS. 10-14, regarding the artificial valve ring 100 mentioned above, the artificial valve ring 100 can be a self-forming artificial valve ring device, and the artificial valve ring 100 can include a main body wire 110, a proximal release structure 120, a developing member 130, and a distal protection member 140.

[0113] The artificial valve ring 100 is entirely accommodated in a delivery sheath tube matched therewith before implantation, and is pushed or recycled by a delivery member connected to the proximal end thereof. Generally, the delivery member is a delivery wire with considerable length.

[0114] The main body core wire 110 is formed by a metal wire with shape memory characteristics, specifically, a nickel-titanium wire with shape memory function is processed by grinding and heat setting. The whole is in a spiral spring structure, and the spiral angle can be clockwise or counterclockwise. In this embodiment, the structure with counterclockwise spiral angle is described. It should be understood that, due to the saddle-shaped and asymmetric anatomical structure of the mitral valve, the spiral angle difference has little effect on the implantation of the artificial annulus device except for the adaptation of the direction habit.

[0115] The part of the main body core wire 110 close to the distal end A extends along an Archimedes spiral. It should be understood that, in this embodiment, the proximal end and the distal end are as generally understood, the proximal end closer to the operator during implantation, and the distal end reaching the predetermined landing position first. The Archimedes spiral is a trajectory generated by a point moving away from a fixed point at a constant speed while rotating around the fixed point at a fixed angular velocity, which belongs to an equal speed ratio spiral. Since it expands outward at equal distances in each rotation period, it can also be called an equal distance spiral, which is a basic geometric concept and will not be described here.

[0116] The number of spiral turns of the main body core wire 110 is not less than two turns, generally 2-8 turns, which can be selected and made according to the actual operation situation, and the part extending along the Archimedes spiral is 1 / 4-1 / 2 turn of the most distal end. The 1 / 4-1 / 2 turn of the most distal end extending along the Archimedes spiral can make the distal end of the main body core wire 110 pass along the outside of the chordae tendineae or the mitral valve leaflet as much as possible.

[0117] Specifically, the main body core wire 110 includes a main body segment 111 and a distal end grinding segment 112 located at the distal end of the main body segment 111. The distal end grinding segment 112 is located in the part of the main body core wire 110 extending along the Archimedes spiral. Preferably, the outer diameter of the distal end grinding segment 112 decreases smoothly in the direction towards the distal end, so that the distal end grinding segment 112 forms an elongated cone. The elongated cone-shaped distal end grinding structure has certain flexibility and self-adaptability, which can meet the outside passing while avoiding damage to the intraventricular wall.

[0118] The proximal end release structure 120 is connected to the proximal end of the main body core wire 110. Specifically, the proximal end release structure 120 is configured to be released from the matching delivery member (i.e. the delivery wire 200) in any one of mechanical release, electrolytic release, and hydrolytic release, and the proximal end release structure 120 can be completely accommodated in the matching delivery sheath tube driven by the delivery wire 200 before release.

[0119] This application describes three release forms using mechanical release:

[0120] The first release form: the proximal end release structure 120 includes a ball 121, and the end of the delivery wire 200 is correspondingly provided with a clamping jaw 210 which is opened outward in a natural state (i.e. a state without external ring pressure), and an arc-shaped groove 211 is formed on the clamping jaw 210 and matched with the surface of the ball 121, so that the overall matched outer diameter is not excessively increased when the clamping jaw 210 clamps the ball 121, and the clamping jaw 210 is conveniently accommodated in the delivery sheath. The release principle is that when the delivery wire 200 is pushed to make the clamping jaw 210 exposed from the distal end of the delivery sheath, the clamping jaw 210 is opened under the action of its own elastic force, and the artificial valve annulus 100 is released.

[0121] The second release form: the proximal end release structure 120 includes a tube 122, and a T-shaped limiting groove 122a is formed on the side wall of the tube 122, and the end of the delivery wire 200 is correspondingly provided with a clamping jaw 210 which is opened outward in a natural state (i.e. a state without external ring pressure), and a T-shaped block 212 is formed on the clamping jaw 210 and matched with the T-shaped limiting groove 122a of the ball, so that the overall matched outer diameter is not excessively increased when the clamping jaw 210 clamps the tube 122, and the clamping jaw 210 is conveniently accommodated in the delivery sheath, and the release principle is similar to the first release form, which is not described herein.

[0122] The third release form: the proximal end release structure 120 includes a first limiting buckle 123, one side of the first limiting buckle 123 is formed with a limiting bayonet 123a, and the end of the delivery wire 200 is correspondingly provided with a second limiting buckle 220, and a matched bayonet 221 matched with the limiting bayonet 123a is formed on the second limiting buckle 220, the connection of the first limiting buckle 123 and the second limiting buckle 220 is realized through the clamping limiting of the matched bayonet 221 and the limiting bayonet 123a, and the second limiting buckle 220 is designed to swing away from the matched bayonet 221 in a natural state (i.e. a state without external ring pressure), so that the automatic release is realized.

[0123] The fourth release form: the proximal end release structure 120 is provided with an internal thread, and the end of the delivery wire 200 is correspondingly provided with an external thread, and the connection of the proximal end release structure 120 and the delivery wire 200 is realized through the threaded connection between the internal thread and the external thread, so that the release of the two is realized through the threaded screwing. After the delivery device reaches the target lesion position, only a pushing or retracting action is needed, so that the artificial valve annulus 100 can be wound around the chordae tendineae or the valve leaflet, and 100% artificial valve annulus 100 can be recycled, and the recycling times are unlimited, which can effectively improve the success rate of surgery.

[0124] The developing member 130 is arranged on the part of the main body core wire 110 close to the distal end, wherein the developing member 130 comprises a developing spring 131, the developing spring 131 is made of platinum-tungsten alloy, platinum-iridium alloy or gold wire which has developing property under X-ray or ultrasound, the developing spring 131 is arranged without affecting the flexibility of the main body core wire 110, and the developing spring 131 can be fully developed under X-ray or ultrasound and can be accurately positioned during the implantation of the artificial valve ring 100; the artificial valve ring 100 can be used for mitral valve replacement under ultrasound alone; compared with the existing commercial products, the operation process is simpler and the operation time is obviously shortened because the DSA and ultrasound equipment need to be frequently used alternately during the operation.

[0125] Preferably, the developing spring 131 is welded or glued to the main body core wire 110.

[0126] The distal end protection member 140 is arranged on the distal end of the main body core wire 110.

[0127] The distal end protection member 130 is made of metal wire with shape memory property and is woven into a predetermined three-dimensional shape, wherein the metal wire used for the distal end protection member 130 is thinner than the metal wire used for the main body core wire 110, and specifically, in the embodiment, the distal end protection member 140 is made of extremely thin nickel-titanium wire and platinum-tungsten wire and is mixed and woven, and is heat set as a whole to be spherical cage or water drop shape with a diameter of 2-5 mm. The distal end protection member 140 with the above structure has certain elasticity and shape memory function, which is beneficial to protecting the inner wall of the ventricle from being damaged and does not affect the pushing and recovery of the artificial valve ring 100 in the delivery sheath tube matched with the artificial valve ring 100.

[0128] Preferably, the artificial valve ring 100 comprises a surface lubricating layer which is uniformly covered on the outer surface of the main body core wire 110, the proximal end release structure 120, the developing member 130 and the distal end protection member 140. The surface lubricating layer is any one of medical grade fluorine-containing material heat shrink tube, hydrophilic coating and hydrophobic coating, and the surface lubricating layer can greatly reduce the resistance to the inner wall of the ventricle during the delivery process.

[0129] The artificial valve ring 100 provided in the application is released through the delivery system matched with the artificial valve ring 100, and the cooperation relationship between the artificial valve ring 100 and the artificial valve 300 is shown in FIG. 13, and the cooperation relationship between the artificial valve ring 100 and the native valve leaflet / tendon 400 is shown in FIG. 14, the native valve leaflet / tendon 400 is clamped between the artificial valve ring 100 and the artificial valve 300, and preferably, in actual operation, the inner diameter of the artificial valve ring 100 is slightly smaller than the outer diameter of the artificial valve 300, so that the artificial valve ring 100 can tightly clamp the artificial valve 300, and the risk of paravalvular leakage and left ventricular outflow tract obstruction can be effectively prevented.

[0130] It can be understood that the artificial annulus 100 provided by the application can also be implanted using the ring shrinking mechanism in mitral valve repair, which will not be repeated here.

[0131] According to the above description, the self-forming artificial annulus device provided by the embodiments of the application has at least the following advantages:

[0132] 1. The artificial annulus structure for mitral valve replacement is designed innovatively, which enhances its stability without causing outflow tract obstruction risk.

[0133] 2. The unique Archimedes spiral outward expansion structure design at the distal end can greatly improve the probability of winding the chordae tendineae or valve leaflets, effectively improving the success rate of mitral valve replacement surgery.

[0134] 3. The distal end protection with flexibility and support can adapt to various narrow and uneven inner surface of the left ventricular space, and does not damage the internal tissues of the ventricle during the bypass process, which can greatly reduce the risk of postoperative complications.

[0135] 4. The release action of the artificial annulus device in the application is simple and easy to operate. After the matching delivery system is in place, only the push or withdrawal of the delivery wire action is needed to achieve the winding of the chordae tendineae or valve leaflets and to meet the 96% or more length of the artificial ring recycling. The recycling times are unlimited, which can effectively improve the success rate of surgery.

[0136] 5. The artificial annulus device in the embodiment can be fully visualized under X-ray or ultrasound, and can be accurately positioned. It can realize the mitral valve replacement under ultrasound alone. The few commercial products need to frequently alternate the use of DSA and ultrasound equipment during the operation, and the operation process is complex and the operation time is longer.

[0137] 6. The artificial annulus device has multiple release paths, which can meet the percutaneous and transapical paths at the same time. The percutaneous path can be released through the femoral artery or femoral vein. It breaks through the technical barrier of the current commercial products which mainly use the transapical path.

[0138] 7. The artificial annulus device has low manufacturing and processing cost and high realization rate, which can greatly reduce the product cost.

[0139] 8. The artificial annulus device does not affect the opening and closing of the mitral valve during the release process, which can greatly reduce the heart load and the probability of postoperative complications such as atrial fibrillation.

[0140] 9. The artificial annulus device can tightly clamp the chordae tendineae or valve leaflets with the artificial valve, and the cooperation is tight, firm and reliable, which can effectively reduce the risk of paravalvular leakage and outflow tract obstruction.

[0141] Any combination of the technical features in the above-described embodiments can be made, and for the sake of brevity, not all possible combinations are described, however, it is to be understood that the application embraces all such possible combinations.

[0142] The above-described embodiments only express several implementation manners of the application, and the description is relatively detailed, but it should not be understood as a limitation on the patent scope of the application. It should be pointed out that, for ordinary skilled persons in the art, some modifications and improvements can be made without departing from the concept of the application, and these all belong to the protection scope of the application. Therefore, the patent protection scope of the application should be subject to the appended claims.

Claims

1. A self-forming artificial valve annulus delivery device, characterized in that, The self-forming artificial valve delivery device includes: An external delivery sheath assembly, the external delivery sheath assembly including an external delivery catheter; An inner delivery sheath assembly includes an inner delivery conduit and an inner control wire. The inner delivery conduit is movably inserted into the inner lumen of the outer delivery conduit. The inner delivery conduit includes a first main tube segment and a first bending tube segment along its axial direction. The distal end of the first main tube segment is connected to the proximal end of the first bending tube segment. The first bending tube segment is flexible. The inner control wire is connected to the first bending tube segment and is used to control the active bending of the first bending tube segment. An inner core rod is pushed through the inner cavity of the inner delivery catheter. The distal end of the inner core rod is used to connect to the artificial valve annulus, and the inner cavity of the inner delivery catheter is used to receive the artificial valve annulus.

2. The self-forming artificial valve annulus delivery device according to claim 1, characterized in that, The first bending pipe section includes a first unit pipe section and a second unit pipe section. The hardness of the first unit pipe section is less than that of the second unit pipe section. The proximal end of the first unit pipe section is connected to the distal end of the second unit pipe section, and the proximal end of the second unit pipe section is connected to the distal end of the first main pipe section.

3. The self-forming artificial valve annulus delivery device according to claim 2, characterized in that, The internal control wire includes a first unit wire and a second unit wire. The first unit wire is connected to the distal end of the first unit pipe segment and is used to control the active bending of the first unit pipe segment. The second unit wire is connected to the distal end of the second unit pipe segment and is used to control the active bending of the second unit pipe segment.

4. The self-forming artificial valve annulus delivery device according to claim 1, characterized in that, The internal delivery conduit also includes: The first transition pipe section has its distal end connected to the proximal end of the first bending pipe section, and its proximal end connected to the distal end of the first main pipe section. The distal end of the first main pipe section is connected to the proximal end of the first bending pipe section through the first transition pipe section.

5. The self-forming artificial valve annulus delivery device according to claim 4, characterized in that, The hardness of the first transition pipe section is greater than that of the first bending pipe section, and the hardness of the first transition pipe section is less than that of the first main pipe section.

6. The self-forming artificial valve annulus delivery device according to claim 1, characterized in that, The internal delivery sheath assembly includes: A first delivery handle is connected to the inner delivery conduit and is also connected to the inner control wire for controlling the movement of the inner control wire along the axial direction of the inner delivery conduit.

7. The self-forming artificial valve annulus delivery device according to claim 6, characterized in that, The first delivery handle includes: A first guide sleeve, the distal end of which is connected to the proximal end of the inner delivery conduit, and a first axial guide rail is provided on the first guide sleeve. The first guide slide is movably mounted on the first guide sleeve along the first axis guide rail, and the first guide slide is connected to the inner control wire. A first control element is threadedly mounted on the first guide sleeve, wherein the first control element is connected to the first guide slide and is used to control the first guide slide to move relative to the first guide sleeve along the first axis guide rail.

8. The self-forming artificial valve annulus delivery device according to claim 1, characterized in that, The external delivery sheath assembly also includes an external control wire, and the external delivery conduit includes a second main tube section and a second bending tube section along its axial direction, with the distal end of the second main tube section connected to the proximal end of the second bending tube section.

9. The self-forming artificial valve annulus delivery device according to claim 8, characterized in that, The second bending pipe section has a bendable function, and the external control wire is connected to the second bending pipe section. The external control wire is used to control the active bending of the second bending pipe section.

10. The self-forming artificial valve annulus delivery device according to claim 8, characterized in that, The external delivery conduit also includes: The second transition pipe section has its distal end connected to the proximal end of the second bending pipe section, and its proximal end connected to the distal end of the second main pipe section. The distal end of the second main pipe section is connected to the proximal end of the second bending pipe section through the second transition pipe section.

11. The self-forming artificial valve annulus delivery device according to claim 10, characterized in that, The hardness of the second transition pipe section is greater than that of the second bending pipe section, and the hardness of the second transition pipe section is less than that of the second main pipe section.

12. The self-forming artificial valve annulus delivery device according to claim 8, characterized in that, The external delivery sheath assembly includes: The second delivery handle is connected to the outer delivery conduit and is also connected to the outer control wire for controlling the movement of the outer control wire along the axial direction of the outer delivery conduit.

13. The self-forming artificial valve annulus delivery device according to claim 12, characterized in that, The second conveying handle includes: The second guide sleeve has its distal end connected to the proximal end of the inner delivery conduit, and a second axial guide rail is provided on the second guide sleeve. The second guide slide is movably mounted on the second guide sleeve along the second axis guide rail, and the second guide slide is connected to the inner control wire. The second control element is threadedly mounted on the second guide sleeve, wherein the second control element is connected to the second guide slide and is used to control the movement of the second guide slide relative to the second guide sleeve along the second axis guide rail.

14. The self-forming artificial valve annulus delivery device according to claim 1, characterized in that, The inner delivery conduit includes a first inner tube, a first middle tube, and a first outer tube along its radial direction. The first inner tube is sleeved in the inner cavity of the first middle tube, and the first middle tube is sleeved in the inner cavity of the first outer tube.

15. The self-forming artificial valve annulus delivery device according to claim 14, characterized in that, The material of the first inner tube includes at least one of polytetrafluoroethylene and polyimide.

16. The self-forming artificial valve annulus delivery device according to claim 14, characterized in that, The first middle layer tube is made of stainless steel braided mesh or hyaluronic acid tube.

17. The self-forming artificial valve annulus delivery device according to claim 14, characterized in that, The first outer tube is made of medical polymer tubing.

18. The self-forming artificial valve annulus delivery device according to claim 1, characterized in that, The external delivery conduit includes a second inner tube, a second middle tube, and a second outer tube along its radial direction. The second inner tube is sleeved in the inner cavity of the second middle tube, and the second middle tube is sleeved in the inner cavity of the second outer tube.

19. The self-forming artificial valve annulus delivery device according to claim 18, characterized in that, The material of the second inner tube includes at least one of polytetrafluoroethylene and polyimide.

20. The self-forming artificial valve annulus delivery device according to claim 18, characterized in that, The second middle layer tube is made of stainless steel braided mesh or hyaluronic acid tube.

21. The self-forming artificial valve annulus delivery device according to claim 18, characterized in that, The second outer tube is made of medical polymer tubing.

22. The self-forming artificial valve annulus delivery device according to claim 1, characterized in that, The artificial valve annulus includes a main core wire, a proximal release structure, a radiopaque element, and a distal protective element; The main core wire is formed by processing metal wire with shape memory properties. The main core wire has a spiral spring-like structure. The part of the main core wire near the far end extends outward along the Archimedean spiral. The proximal release structure is connected to the proximal end of the main core wire; The developing element is disposed on the portion of the main core wire near the distal end; The distal protective element is disposed at the distal end of the main core wire.

23. The self-forming artificial valve annulus delivery device according to claim 22, characterized in that, The main core wire has no less than two spiral turns, and the portion extending outward along the Archimedean spiral is 1 / 4 to 1 / 2 of the furthest turn.

24. The self-forming artificial valve annulus delivery device according to claim 22, characterized in that, The main core wire includes a main body segment and a distal grinding segment located within the main body segment. The distal grinding segment is entirely located in the portion of the main core wire that extends outward along the Archimedean spiral.

25. The self-forming artificial valve annulus delivery device according to claim 24, characterized in that, The outer diameter of the distal grinding section decreases smoothly in the direction toward the distal end, making the distal grinding section a slender cone shape.

26. The self-forming artificial valve annulus delivery device according to any one of claims 22 to 25, characterized in that, The developing element includes a developing spring, which is made of platinum-tungsten alloy, platinum-iridium alloy or gold wire that is radiopaque under X-ray or ultrasound.

27. The self-forming artificial valve annulus delivery device according to claim 25, characterized in that, The developing spring is attached to the main core wire by welding or gluing.

28. The self-forming artificial valve annulus delivery device according to any one of claims 22 to 25, characterized in that, The remote protective component is woven from metal wires with shape memory properties into a predetermined three-dimensional shape, and the metal wires used in the remote protective component are thinner than the metal wires used in the main core wire.

29. The self-forming artificial valve annulus delivery device according to claim 28, characterized in that, The distal protective component is a spherical or teardrop-shaped structure with a diameter of 2 to 5 mm.

30. The self-forming artificial valve annulus delivery device according to any one of claims 22 to 25, characterized in that, The proximal release structure is configured to release itself from the compatible conveyor via any one of mechanical release, electrical release, or water release, and the proximal release structure can be completely contained into the matching conveyor sheath by the conveyor before it is released.

31. The self-forming artificial valve annulus delivery device according to claim 30, characterized in that, The proximal release structure includes a sphere, and the end of the conveyor is provided with a gripper, on which an arc-shaped groove adapted to the sphere is formed.

32. The self-forming artificial valve annulus delivery device according to claim 30, characterized in that, The proximal release structure includes a tube body, the sidewall of which is formed with a T-shaped limiting groove, and the end of the conveying component is provided with a gripper, on which a T-shaped block adapted to the limiting groove is formed.

33. The self-forming artificial valve annulus delivery device according to claim 30, characterized in that, The proximal release structure includes a first limiting buckle, one side of which forms a limiting slot, and a second limiting buckle is correspondingly provided at the end of the conveying member, the second limiting buckle having a mating slot adapted to the limiting slot.

34. The self-forming artificial valve annulus delivery device according to claim 30, characterized in that, The proximal release structure is provided with an internal thread, and the end of the conveying component is provided with an external thread. The proximal release structure and the end of the conveying component are threadedly connected.

35. The self-forming artificial valve annulus delivery device according to claim 22, characterized in that, It also includes a surface lubricating layer, which uniformly covers the outer surfaces of the main core wire, the proximal release structure, the developing element, and the distal protection element.

36. The self-forming artificial valve annulus delivery device according to claim 35, characterized in that, The surface lubricating layer is any one of medical-grade fluorine-containing heat shrink tubing, hydrophilic coating, or hydrophobic coating.

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