Mitral valve annulus system

Abstract

The present application provides a mitral valve annulation system, including a delivery device and an implantation device; the implantation device includes a distal anchor, a proximal anchor, a locking structure and a locking wire; the distal anchor is used to anchor in the great cardiac vein, the proximal anchor is used to anchor in the coronary sinus, the locking structure is fixed to the proximal end of the proximal anchor, the distal end of the locking wire is fixed to the proximal end of the distal anchor, and the locking wire passes through the proximal anchor and the locking structure; the unlocking piece of the locking structure is connected to the delivery device, and the proximal end of the locking wire is connected to the delivery device, and the delivery device can implant the distal anchor, the proximal anchor, the locking structure and the locking wire into the human body; the delivery device can control the opening and closing of the locking structure through the unlocking piece; the delivery device can drive the distal anchor close to or away from the proximal anchor, so as to achieve the adjustment of the relative position of the distal anchor and the proximal anchor, and adjust the degree of annulation of the mitral valve by the proximal anchor and the distal anchor to achieve a better annulation effect; in addition, implanting the implantation device into the human body through the delivery device is beneficial to the functional repair of the mitral valve.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a mitral valve annulus contraction system. Background Art

[0002] The mitral valve is a complex structure of tissue between the left atrium (LA) and the left ventricle (LV), consisting of the mitral annulus, the anterior and posterior leaflets, the chordae tendineae, and the papillary muscles. The mitral valve acts as a gatekeeper, ensuring that blood can only flow from the left atrium to the left ventricle and not vice versa. In a healthy mitral valve, the geometry of the mitral valve ensures that the leaflets overlap to prevent the backflow of blood during left ventricular contraction. Dilated cardiomyopathy, caused by disease or certain natural defects, may impair the normal function of the mitral valve in preventing regurgitation. For example, certain diseases may dilate the mitral annulus and distort the geometry of the mitral valve, leading to mitral insufficiency during left ventricular contraction, resulting in blood leakage and regurgitation.

[0003] Surgery is an effective treatment for mitral regurgitation. However, for patients who are elderly, have a history of open-chest surgery, have poor cardiac function, or have concurrent multi-organ dysfunction, surgery can be invasive, difficult to heal, and can be associated with numerous complications and risks, which some patients may not tolerate. With the continuous advancement of medical technology, minimally invasive interventional procedures are now a more effective treatment option for most valvular heart diseases. Key interventional treatments include artificial chordae tendineae implantation, mitral annuloplasty, and mitral valve edge-to-edge repair. There are two types of annuloplasty: direct annuloplasty and indirect annuloplasty. Indirect annuloplasty primarily constricts the vascular tissue surrounding the mitral annulus, constricting the mitral valve annulus and tightening the mitral valve leaflets. The coronary sinus and great cardiac vein are vessels surrounding the mitral annulus, making them ideal candidates for indirect annuloplasty.

[0004] Currently, an indirect annuloplasty procedure has been disclosed. The device enters the body through the jugular vein and is implanted in the coronary sinus and the great cardiac vein. The device has two anchors, the distal anchor is anchored in the great cardiac vein, and the proximal anchor is anchored in the coronary sinus, connected by a connector in the middle. By tightening the device, inward pressure is applied to the mitral valve annulus, causing the mitral valve annulus to contract and basically restore its normal geometric shape, thereby closing the mitral valve leaflets tightly and improving mitral valve regurgitation.

[0005] However, in existing implant devices, the distance between the proximal and distal anchors is fixed, and after the implant device is released in the body, the distance between the proximal and distal anchors cannot be adjusted, that is, the degree of ring contraction cannot be adjusted after release. In addition, in the prior art, there is no good delivery device for implanting the implant device into the human body. Summary of the Invention

[0006] The present application provides a mitral valve annulus contraction system to solve the technical problem in the prior art that the distance between the proximal anchor and the distal anchor in the implant device cannot be adjusted.

[0007] To solve the above problems, the technical solutions provided in the embodiments of the present application are: a mitral valve annulus contraction system, comprising a delivery device and an implantation device;

[0008] The implant device includes a distal anchor, a proximal anchor, a locking structure, and a locking wire; the distal anchor is used to anchor in the great cardiac vein, the proximal anchor is used to anchor in the coronary sinus, the locking structure is fixed to the proximal end of the proximal anchor, the distal end of the locking wire is fixed to the proximal end of the distal anchor, and the locking wire is arranged through the proximal anchor and the locking structure;

[0009] The unlocking piece of the lock structure is connected to the delivery device, and the proximal end of the lock wire is connected to the delivery device. The delivery device can implant the distal anchor, the proximal anchor, the lock structure and the lock wire into the human body; and the delivery device can control the opening and closing of the lock structure through the unlocking piece to lock or release the lock wire; the delivery device can also drive the lock wire and the distal anchor to move closer to or away from the proximal anchor.

[0010] According to the mitral valve annulation system provided in the embodiment of the present application, a delivery device is provided, and the unlocking part of the locking structure is connected to the delivery device, so that the delivery device can control the opening and closing of the locking structure through the unlocking part to lock and unlock the locking wire, and at the same time, the proximal end of the locking wire is connected to the delivery device. Then, when the locking structure and the locking wire are unlocked, the locking wire can be driven by the delivery device to move the distal anchor closer to or away from the proximal anchor, thereby realizing the adjustment of the relative position between the distal anchor and the proximal anchor, and then adjusting the degree of annulation of the mitral valve by the proximal anchor and the distal anchor to achieve a better annulation effect; in addition, the distal anchor, the proximal anchor, the locking structure and the locking wire can be delivered to the human body through the delivery device, thereby facilitating the implantation and application of the implant device, and thus facilitating the functional repair of the mitral valve.

[0011] In one possible design, the delivery device includes:

[0012] Delivery handle;

[0013] a lock control member, the lock control member being mounted on the delivery handle, the proximal end of the unlocking member being connected to the lock control member, the lock control member being used to drive the unlocking member to control the opening and closing of the lock structure;

[0014] A locking wire drive assembly is installed on the conveying handle, the locking wire drive assembly at least partially extends out of the conveying handle to be connected to the locking wire, and the locking wire drive assembly is used to drive the locking wire to move.

[0015] In one possible design, the lock wire drive assembly includes a core wire and a core wire adjustment assembly, the distal end of the core wire extends outside the delivery handle to form a detachable connection with the proximal end of the lock wire, the proximal end of the core wire is connected to the core wire adjustment assembly, and the core wire adjustment assembly is installed in the delivery handle and is used to drive the core wire to move together with the lock wire.

[0016] In one possible design, the core wire adjustment assembly includes a core wire knob and a core wire fixing structure, the core wire fixing structure is fixedly connected to the proximal end of the core wire, the core wire fixing structure is slidably arranged in the delivery handle, the core wire knob is rotatably arranged in the delivery handle, and the core wire knob is threadedly sleeved on the core wire fixing structure.

[0017] In one possible design, the core wire fixing structure includes a first fixing member and a second fixing member, the first fixing member is slidably arranged in the delivery handle, the first fixing member is movably sleeved on the outside of the core wire, the second fixing member is used to fix the core wire on the first fixing member, and the core wire knob is threadedly sleeved on the first fixing member.

[0018] In a possible design, a core wire anti-rotation groove is provided in the delivery handle, and the core wire fixing structure is at least partially slidably accommodated in the core wire anti-rotation groove.

[0019] In one possible design, the delivery device further includes a proximal anchor drive assembly, which is installed in the delivery handle; the proximal anchor drive assembly at least partially extends out of the delivery handle to connect with the proximal anchor and is used to drive the proximal anchor to move.

[0020] In one possible design, the proximal anchor drive assembly includes a push rod and a push rod adjustment assembly, the distal end of the push rod forms a detachable connection with the proximal end of the locking structure, the proximal end of the push rod is connected to the push rod adjustment assembly, and the push rod adjustment assembly is installed in the delivery handle and is used to drive the push rod, the locking structure and the proximal anchor to move together.

[0021] In one possible design, the push rod adjustment assembly includes a push rod knob and a push rod fixing piece, the push rod fixing piece is fixed to the proximal end of the push rod, the push rod fixing piece is slidably provided on the delivery handle, the push rod knob is rotatably provided on the delivery handle, and the push rod knob is threadedly sleeved on the push rod fixing piece.

[0022] In a possible design, the push rod fixing piece is sleeved on the push rod, and a sealing piece is abutted between the push rod fixing piece and the push rod.

[0023] In a possible design, a push rod anti-rotation groove is provided in the conveying handle, and the push rod fixing member is slidably accommodated in the push rod anti-rotation groove.

[0024] In one possible design, the lock structure includes:

[0025] a locking seat, fixed to the proximal end of the proximal anchor;

[0026] A locking piece is arranged in the inner cavity of the lock seat, and the locking wire is arranged through the locking piece;

[0027] An elastic member is provided in the inner cavity of the lock seat, and the locking plate is tilted under the elastic action of the elastic member to clamp the lock wire; the unlocking member is used to rotate the locking plate to a state perpendicular to the lock wire to loosen the lock wire.

[0028] In one possible design, the unlocking member is an unlocking rope, the two ends of the unlocking rope are respectively connected to the lock control member, the middle part of the unlocking rope passes through the opposite ends of the locking plate, and the lock control member is used to drive the unlocking rope to pull the locking plate to a state perpendicular to the lock wire.

[0029] In one possible design, the delivery device further includes a protective sleeve and a protective sleeve adjustment assembly;

[0030] The proximal end of the protective sleeve is connected to the protective sleeve adjustment assembly, the distal end of the protective sleeve extends out of the delivery handle, the protective sleeve is coaxially sleeved outside the push rod, and the push rod is coaxially sleeved outside the core wire; the protective sleeve adjustment assembly is installed in the delivery handle, and the protective sleeve adjustment assembly is used to drive the protective sleeve to move;

[0031] The protective cover is provided with two wire holes, and the unlocking rope is respectively passed through the two wire holes.

[0032] In a possible design, the protective cover has a center hole and two wire holes. The center hole is sleeved on the push rod. The two wire holes are symmetrically arranged relative to the center hole. The two wire holes are respectively used to allow different parts of the unlocking rope to pass through.

[0033] In one possible design, the protective cover adjustment assembly includes a protective cover knob and a protective cover fixing piece, the protective cover fixing piece is fixed to the proximal end of the protective cover, the protective cover fixing piece is slidably arranged in the delivery handle, the protective cover knob is rotatably arranged on the delivery handle, and the protective cover knob is threadedly sleeved on the protective cover fixing piece.

[0034] In one possible design, the delivery device also includes a delivery sheath and a loader, and the loader is connected between the delivery sheath and the delivery handle; the delivery sheath is used to guide insertion into the human body, and the loader is used to load the distal anchor, the proximal anchor, the locking wire and the locking structure, and the distal anchor, the proximal anchor, the locking wire and the locking structure are loaded into the delivery sheath from the loader. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0036] Figure 1 1 is a schematic structural diagram of an implantable device for a mitral valve annulation system according to an embodiment of the present application;

[0037] Figure 2 yes Figure 1 Schematic diagram of the first type of structure of the middle locking wire;

[0038] Figure 3 yes Figure 1 Schematic diagram of the second type of structure of the middle locking wire;

[0039] Figure 4 yes Figure 1 Schematic diagram of the third type of structure of the middle locking wire;

[0040] Figure 5 Schematic diagram of the structure of the delivery device of the mitral valve annulation system provided in an embodiment of the present application;

[0041] Figure 6 is an exploded schematic diagram of a delivery device of a mitral valve annulation system provided in an embodiment of the present application;

[0042] Figure 7 This is a schematic cross-sectional view of the assembly of the lock wire, core wire, push rod, lock structure and protective cover provided in an embodiment of the present application;

[0043] Figure 8 is a schematic cross-sectional view of a proximal anchor drive assembly provided in an embodiment of the present application;

[0044] Figure 9 This is a structural diagram of a lock control member controlling lock closing provided in an embodiment of the present application;

[0045] Figure 10 This is a schematic diagram of the lock control member provided in the embodiment of the present application controlling the lock to close;

[0046] Figure 11 yes Figure 5 A schematic cross-sectional view of the middle protective cover;

[0047] Figure 12 Schematic diagram of the structure of the delivery sheath provided in an embodiment of the present application;

[0048] Figure 13 is a structural diagram of a loader provided in an embodiment of the present application;

[0049] Figure 14 This is an exploded schematic diagram of the locking wire, core wire, push rod and protective cover provided in an embodiment of the present application;

[0050] Figure 15 This is a schematic diagram of the connection between the lock wire and the core wire provided in an embodiment of the present application;

[0051] Figure 16 It is a schematic diagram of the connection between the lock structure and the push rod provided in an embodiment of the present application.

[0052] Figure numerals: 10, distal anchor; 20, proximal anchor; 30, locking wire; 40, locking structure; 41, locking seat; 42, locking plate; 43, elastic member; 50, delivery handle; 51, upper shell; 52, lower shell; 53, mounting cavity; 54, core wire anti-rotation groove; 55, push rod anti-rotation groove; 56, protective cover anti-rotation groove; 60, lock control member; 70, unlocking member; 80, locking wire drive assembly; 81, core wire; 82, core wire adjustment assembly; 821, core wire knob; 822, core wire fixing structure; 8221, first fixing member; 8222, second fixing member; 8223, first limiting surface; 90, proximal anchor drive assembly; 91, Push rod; 92, push rod adjustment assembly; 921, push rod knob; 9211, first slot; 922, push rod fixing piece; 9221, connecting part; 9222, anti-rotation part; 923, sealing piece; 924, machine screw; 925, push rod locking piece; 100, protective cover; 101, center hole; 102, wire hole; 110, protective cover adjustment assembly; 111, protective cover knob; 1111, second slot; 112, protective cover fixing piece; 113, protective cover locking piece; 120, delivery sheath; 121, Y valve; 130, loader; 131, connector end; 132, threaded end; 140, loader knob. DETAILED DESCRIPTION

[0053] To make the purpose, technical solutions, and advantages of the embodiments of this application more clear, the technical solutions in the embodiments of this application will be clearly and completely described below in conjunction with the drawings in the embodiments of this application. Obviously, the described embodiments are part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0054] In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly defined. In this application, unless otherwise clearly defined and defined, the terms "installed", "connected", "connected", "fixed", etc. should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral whole; it can be directly connected or indirectly connected through an intermediate medium; it can be internal communication between two elements or an interactive relationship between two elements, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0055] In this application, unless otherwise expressly specified or limited, when a first feature is "above" or "below" a second feature, it may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Furthermore, when a first feature is "above," "above," or "above" a second feature, it may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. When a first feature is "below," "below," or "below" a second feature, it may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0056] It should also be noted that, in the embodiments of the present application, the same figure mark represents the same component or the same part. For the same parts in the embodiments of the present application, the figure may only mark one of the parts or components as an example. It should be understood that the figure mark also applies to other identical parts or components.

[0057] The coronary sinus and great cardiac vein are primarily vessels surrounding the mitral valve annulus, making them ideal candidates for indirect annuloplasty. For ease of description, the term "distal" refers to the direction of insertion into the patient's body, and the term "proximal" refers to the direction of removal from the patient's body.

[0058] An embodiment of the present application provides a mitral valve annulation system, including a delivery device and an implantation device. The delivery device is connected to the implantation device, the delivery device is used to deliver the implantation device into the human body, and the implantation device is used to be implanted in the human body to achieve an annulation effect on the mitral valve.

[0059] See also Figure 1 The implant device includes a distal anchor 10, a proximal anchor 20, a locking structure 40 and a locking wire 30.

[0060] The distal anchor 10 is used to anchor the great cardiac vein. Specifically, the distal anchor 10 is configured as a self-expanding anchor, having two states: a compressed state and an expanded state. In the compressed state, the distal anchor 10 can be inserted into the coronary sinus or other coronary vessels. In the expanded state, the distal anchor 10 expands and conforms to the wall of the great cardiac vein, expanding the vessel and thereby anchoring it within the vessel. Specifically, the distal anchor 10 can be a conventional self-expanding anchor, which can be a metal anchor cut from a shape-memory metal or a self-expanding balloon structure, and the specific choice can be based on actual needs.

[0061] The proximal anchor 20 is used to anchor the coronary sinus. Specifically, the proximal anchor 20 is also configured as a self-expanding anchor, having two states: a compressed state and an expanded state. In the compressed state, the proximal anchor 20 can be inserted into the coronary sinus via the jugular vein. In the expanded state, the proximal anchor 20 expands and adheres to the coronary sinus, thereby anchoring the proximal anchor 20 within the coronary sinus.

[0062] The lock structure 40 is fixed to the proximal end of the proximal anchor 20. Specifically, the lock structure 40 is integrally connected to the proximal anchor 20. The lock structure 40 is in a normally closed state. The lock structure 40 is provided with an unlocking member 70 for controlling the opening and closing of the lock structure 40.

[0063] The distal end of the locking wire 30 is fixed to the proximal end of the distal anchor 10. The locking wire 30 is sequentially passed through the proximal anchor 20 and the locking structure 40. The proximal end of the locking wire 30 is connected to the delivery device. When the locking structure 40 is in the closed state, the locking structure 40 locks the locking wire 30, that is, the locking structure 40 prevents relative sliding between the locking wire 30 and the locking structure 40. When the locking structure 40 is in the open state, the locking structure 40 releases the locking wire 30, allowing relative sliding between the locking wire 30 and the locking structure 40, that is, relative sliding between the proximal anchor 20 and the distal anchor 10.

[0064] The unlocking member 70 is connected to the delivery device, and the proximal end of the locking wire 30 is connected to the delivery device. The delivery device can implant the distal anchor 10, the proximal anchor 20, the locking structure 40 and the locking wire 30 into the human body, that is, the delivery device provides a guide path for the distal anchor 10, the proximal anchor 20, the locking structure 40 and the locking wire 30, so that the distal anchor 10, the proximal anchor 20, the locking structure 40 and the locking wire 30 can be directly implanted into the human lesion through the delivery device.

[0065] The delivery device can control the opening and closing of the lock structure 40 through the unlocking member 70, thereby locking or releasing the lock wire 30; the delivery device can also drive the lock wire 30 to move the distal anchor 10 closer to or away from the proximal anchor 20 to adjust the relative distance between the distal anchor 10 and the proximal anchor 20.

[0066] When the mitral valve annulation system of the present application is used, the various structures of the implant device are first assembled, and the unlocking member 70 and the proximal end of the locking wire 30 are respectively connected to the delivery device; then the distal anchor 10, the proximal anchor 20, the locking structure 40 and the locking wire 30 of the implant device are implanted into the human body through the delivery device, and at least part of the delivery device is left outside the human body for staff operation; when the relative position of the distal anchor 10 and the proximal anchor 20 needs to be adjusted, the unlocking member 70 is driven by the part of the delivery device located outside the human body to unlock the locking structure 40 and the locking wire 30, and the locking wire 30 is driven by the delivery device to move the distal anchor 10 close to or away from the proximal anchor 20, thereby achieving the adjustment of the relative position of the distal anchor 10 and the proximal anchor 20; when the position is adjusted, the unlocking member 70 is driven by the delivery device to lock the locking structure 40 and the locking wire 30 with each other, so that the position of the distal anchor 10 is fixed.

[0067] The mitral valve annulation system of the present application is provided with a delivery device, and the unlocking member 70 of the locking structure 40 is connected to the delivery device, so that the delivery device can control the switch of the locking structure 40 through the unlocking member 70 to lock and unlock the locking wire 30, and at the same time, the proximal end of the locking wire 30 is connected to the delivery device. Then, when the locking structure 40 and the locking wire 30 are unlocked, the locking wire 30 can be driven by the delivery device to drive the distal anchor 10 to move closer to or away from the proximal anchor 20, thereby adjusting the relative position between the distal anchor 10 and the proximal anchor 20, and then adjusting the degree of annulation of the mitral valve by the proximal anchor 20 and the distal anchor 10 to achieve a better annulation effect. In addition, the distal anchor 10, the proximal anchor 20, the locking structure 40 and the locking wire 30 can be delivered to the human body through the delivery device, thereby facilitating the implantation and application of the implant device, and further facilitating the functional repair of the mitral valve.

[0068] The locking wire 30 is implanted into the human body structure and is made of medical implant grade metal materials, such as 316LVM stainless steel, nickel titanium alloy, cobalt chromium alloy, etc.

[0069] The locking wire 30 can be made of a single metal wire with a diameter of 0.4-1.0 mm, and the surface is roughened, such as by adding knurling, to increase friction during locking. The locking wire 30 can also be made of multiple strands of wire, twisted and braided, with the diameter of the braided locking wire 30 being within the range of 0.4-1.0 mm.

[0070] For example Figure 2As shown, three wires with the same diameter are twisted and braided to form a 1×3 multi-strand wire to form the locking wire 30.

[0071] Another example Figure 3 As shown, three wires of the same diameter are intertwined and braided into a small strand, and then the three small strands are intertwined and braided into a 3×3 large strand to form a lock wire 30. The lock wire 30 is made of multiple strands to increase its flexibility, allowing it to conform to the curvature of the heart and blood vessels as much as possible, and avoid being too hard to damage the heart.

[0072] Another example Figure 4 As shown, three wires with the same diameter are twisted together to form a small strand, and then nine wires are twisted around the outside of the small strand to tightly wrap the three strands to form a large strand, thereby forming a lock wire 30.

[0073] In one embodiment, see Figure 5 The conveying device includes a conveying handle 50, a lock control component 60 and a lock wire driving assembly 80.

[0074] The delivery handle 50 is always located outside the human body during delivery and adjustment of the implant device. The delivery handle 50 is a handle for hand-held operation. A lock control member 60 is mounted on the delivery handle 50. The proximal end of the unlocking member 70 is movably connected to the lock control member 60. The lock control member 60 is used to drive the unlocking member 70 to control the opening and closing of the lock structure 40, thereby locking or unlocking the lock wire 30. The lock wire drive assembly 80 is mounted on the delivery handle 50. The lock wire drive assembly 80 at least partially extends out of the delivery handle 50 to connect with the lock wire 30. The lock wire drive assembly 80 is used to drive the lock wire 30 to move with the distal anchor 10. The delivery device of the present application, through the arrangement of the delivery handle 50, the lock control member 60, and the lock wire drive assembly 80, allows the delivery device to be operated by holding the delivery handle 50 during delivery of the implant device. At the same time, the lock control member 60 and the lock wire drive assembly 80 are both integrated into the delivery handle 50, making it convenient for the operator to operate the unlocking member 70 and the lock wire 30 on the delivery handle 50. It can be understood that in other embodiments of the present application, according to actual design conditions and specific requirements, the above-mentioned conveying device can also be of other types. For example, the lock control member 60 and the lock wire drive assembly 80 can be set separately instead of being concentrated on one conveying handle 50; for example, the control member, the lock wire drive assembly 80 and the conveying handle 50 are set separately, which is not particularly limited here.

[0075] In one embodiment, see Figures 5 to 7The lock wire drive assembly 80 includes a core wire 81 and a core wire adjustment assembly 82. The distal end of the core wire 81 can extend out of the delivery handle 50 to form a detachable connection with the proximal end of the lock wire 30. The proximal end of the core wire 81 is connected to the core wire adjustment assembly 82. The core wire adjustment assembly 82 is installed in the delivery handle 50 and is used to drive the core wire 81 and the lock wire 30 to move together. In actual application, when the implant device is implanted in the human body and the implant device is adjusted by the delivery device, the distal anchor 10, the proximal anchor 20, the locking structure 40 and the lock wire 30 in the implant device need to remain in the human body. Therefore, the space occupied by the lock wire 30 in the human body should be as small as possible. In this embodiment, by setting the core wire 81 and the core wire adjustment assembly 82, the length of the core wire 81 can be set longer. Then, during implantation, the core wire 81 can be inserted into the human body along with the lock wire 30. After the position of the lock wire 30 is adjusted, the core wire 81 can be withdrawn from the human body, thereby making the lock wire 30 implanted in the human body as short as possible.

[0076] Core wire 81 is a structure that intervenes in the human body and is made of medical-grade metal materials, such as 304V stainless steel, 316LVM stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc. Core wire 81 can be made of a single metal wire or a braided structure of multiple metal wires, similar to the manufacturing process of lock wire 30, and the description thereof will not be repeated here.

[0077] See also Figure 14 and Figure 15 The proximal end of the lock wire 30 is provided with a lock wire connector 31, and the distal end of the core wire 81 is provided with a core wire connector 811, and the core wire connector 811 and the lock wire connector 31 are radially buckled with each other; the push rod 91 is sleeved outside the core wire connector 811 and the lock wire connector 31, and the push rod 91 limits the core wire connector 811 and the lock wire connector 31 to keep the core wire connector 811 and the lock wire connector 31 buckled with each other, and the core wire connector 811 and the lock wire connector 31 can be separated from each other under the elastic action of the core wire 81 after the push rod 91 is withdrawn.

[0078] Specifically, the locking wire connector 31 and the core wire connector 811 are both solid structures with an S-shaped axial cross-section. After the locking wire connector 31 and the core wire connector 811 are radially buckled together, the overall outer surface is cylindrical.

[0079] It should be noted that the axial cross section refers to the cross section parallel to the central axis of the core wire 81. The lock wire connector 31 and the core wire connector 811 are matched in radial concave and convex manner, so that the whole is cylindrical after being fastened. The lock wire connector 31 and the core wire connector 811 can slide in the push rod 91 after being fastened to each other. The present application sets the lock wire connector 31 and the core wire connector 811 into an S-shaped buckle structure, so that after the lock wire connector 31 and the core wire connector 811 are fastened, the connection stability in the push rod 91 is good, which is beneficial to the conveying handle 50 to drive the core wire 81 and the lock wire 30 to move.

[0080] In one embodiment, the core wire adjustment assembly 82 includes a core wire knob 821 and a core wire fixing structure 822. The core wire fixing structure 822 is fixedly connected to the proximal end of the core wire 81. The core wire fixing structure 822 is slidably disposed in the delivery handle 50. The core wire knob 821 is rotatably disposed in the delivery handle 50 and is threadedly sleeved on the core wire fixing structure 822. When the position of the distal anchor 10 needs to be adjusted, the core wire knob 821 is rotated on the delivery handle 50. Since the core wire knob 821 and the core wire fixing structure 822 are threadedly connected, the rotation of the core wire knob 821 is converted into the sliding of the core wire fixing structure 822 on the delivery handle 50, thereby driving the locking wire 30 and the distal anchor 10 to move relative to the proximal anchor 20 via the core wire 81, thereby adjusting the relative distance between the distal anchor 10 and the proximal anchor 20. The present application adjusts the position of the distal anchor 10 by rotating the core wire knob 821. This allows for simple adjustment, smooth transmission, and high adjustment precision, making it suitable for adjusting devices implanted in the human body. It is understood that in other embodiments of the present application, depending on actual design conditions and specific requirements, the core wire adjustment assembly 82 may also be of other types, such as a ball screw structure or a rack and pinion structure, without particular limitation herein.

[0081] In a specific embodiment, the core wire fixing structure 822 includes a first fixing member 8221 and a second fixing member 8222. The first fixing member 8221 is slidably disposed in the delivery handle 50, the first fixing member 8221 is movably sleeved on the outside of the core wire 81, the second fixing member 8222 is used to fix the core wire 81 on the first fixing member 8221, and the core wire knob 821 is threadedly sleeved on the first fixing member 8221. Specifically, the inner diameter of the first fixing member 8221 is approximately 0.5 mm larger than the outer diameter of the core wire 81, thereby ensuring that the core wire 81 and the first fixing member 8221 can slide relative to each other. The second fixing member 8222 is fixed to the proximal end of the first fixing member 8221 by glue, and the inner diameter of the second fixing member 8222 is interference fit with the outer diameter of the core wire 81, so that the core wire 81 can be fixed to the first fixing member 8221 by the second fixing member 8222. When the position of the core wire 81 needs to be adjusted, the core wire knob 821 is rotated to move the first fixing member 8221, thereby moving the second fixing member 8222 and the core wire 81, and thus displacing the lock core and the distal anchor 10. During installation, before the second fixing member 8222 and the first fixing member 8221 are fixed to each other, the initial position of the core wire 81, the lock wire 30, and the distal anchor 10 can be adjusted by pulling the second fixing member 8222.

[0082] Among them, since the second fixing member 8222 is sleeved on the proximal end of the core wire 81, and the second fixing member 8222 and the core wire 81 are interference fit, the second fixing member 8222 and the core wire 81 are sealed and no blood will flow between the second fixing member 8222 and the core wire 81.

[0083] In addition, for ease of operation, the core wire knob 821 is located at the proximal end of the delivery handle 50 , and the second fixing member 8222 is located on the proximal outer side of the delivery handle 50 , so that the staff can adjust the position of the distal anchor 10 on the outer side of the delivery handle 50 .

[0084] See also Figure 5 and Figure 6 In order to prevent the core wire fixing structure 822 from rotating when the core wire knob 821 rotates, a core wire anti-rotation groove 54 is provided in the delivery handle 50, and the core wire fixing structure 822 is at least partially slidably accommodated in the core wire anti-rotation groove 54, thereby ensuring that during the movement of the core wire 81, the core wire 81, the locking wire 30 and the distal anchor 10 can only move and not rotate, thereby ensuring the movement safety of the core wire 81, the locking wire 30 and the distal anchor 10.

[0085] Specifically, the distal end portion of the first fixing member 8221 is slidably accommodated in the core wire anti-rotation groove 54 , and the proximal end of the first fixing member 8221 and the second fixing member 8222 are both located outside the delivery handle 50 .

[0086] The outer surface of the first fixing member 8221 is threaded, and two first limiting surfaces 8223 are formed on the outer periphery of the first fixing member 8221, which are arranged opposite each other in the circumferential direction. The two first limiting surfaces 8223 extend axially along the first fixing member 8221. Correspondingly, the inner wall of the core wire anti-rotation groove 54 is adapted to the outer wall of the first fixing member 8221. The core wire anti-rotation groove 54 has two second limiting surfaces (not shown) arranged opposite each other. The two first limiting surfaces 8223 abut against the two second limiting surfaces in a one-to-one correspondence, thereby preventing the first fixing member 8221 from rotating within the core wire anti-rotation groove 54. It is understood that in other embodiments of the present application, the core wire anti-rotation groove 54 can also be of other types according to actual design conditions and specific requirements. For example, the outer surface of the first fixing member 8221 is provided with a protrusion, and the core wire anti-rotation groove 54 is provided with a sliding groove for securing the protrusion in the corresponding position of the protrusion, which can also prevent the core wire 81 from rotating.

[0087] In one embodiment, see Figure 5 The delivery device further includes a proximal anchor drive assembly 90, which is mounted within the delivery handle 50. The proximal anchor drive assembly 90 at least partially extends out of the delivery handle 50 to connect with the proximal anchor 20. The proximal anchor drive assembly 90 is configured to drive the proximal anchor 20 to move. The present application utilizes the provision of the proximal anchor drive assembly 90, so that when the locking wire 30 and the locking structure 40 are unlocked, the proximal anchor 20 can be driven to move by operating the proximal anchor drive assembly 90 on the delivery handle 50, thereby adjusting the position of the proximal anchor 20. In other words, in this embodiment, when the locking wire 30 and the locking structure 40 are unlocked, the position of the distal anchor 10 can be adjusted using the locking wire drive assembly 80, and the position of the proximal anchor 20 can also be adjusted using the proximal anchor drive assembly 90. This facilitates adjusting the degree of annulation of the mitral valve by the proximal and distal anchors 20, thereby achieving a better annulation effect.

[0088] For details, please refer to Figures 5 to 7 The proximal anchor drive assembly 90 includes a push rod 91 and a push rod adjustment assembly 92. The distal end of the push rod 91 is detachably connected to the proximal end of the lock structure 40. The proximal end of the push rod 91 is connected to the push rod adjustment assembly 92. The push rod adjustment assembly 92 is installed in the delivery handle 50 and is used to drive the push rod 91, the lock structure 40, and the proximal anchor 20 to move together. In actual application, the proximal anchor 20 and the lock structure 40 need to be implanted in the human body. In order to facilitate the adjustment of the position of the proximal anchor 20 at the delivery handle 50, a long, flexible rod-shaped structure is required to extend into the human body to connect the proximal anchor 20 to the delivery handle 50. The present application provides the push rod 91 and the push rod adjustment assembly 92, inserts the push rod 91 into the human body to connect the lock structure 40 to the push rod adjustment assembly 92, and then installs the push rod adjustment assembly 92 in the delivery handle 50. Therefore, the position of the proximal anchor 20 can be adjusted from the delivery handle 50.

[0089] The push rod 91 is made of medical intervention-grade metal materials, such as 304V stainless steel, 316LVM stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc.

[0090] The distal end of the push rod 91 is made of a processed metal tube with good flexibility, such as a spring tube or a snake tube, so as to facilitate the insertion of the push rod 91 into the human body. The proximal end of the push rod 91 is made of a non-specially processed metal tube with good pushing performance, such as a stainless steel tube or a hypotube, so as to facilitate the pushing of the front end of the push rod 91.

[0091] See also Figures 14 to 16 The push rod 91 is provided with a push rod connector 911 at its distal end, and the proximal anchor 20 is provided with a proximal anchor connector 21 at its proximal end. The push rod connector 911 and the proximal anchor connector 21 are interlocked. The protective cover 100 is flexible, and its proximal end is connected to the delivery handle 50. The protective cover 100 is sleeved over the connection between the push rod connector 911 and the proximal anchor connector 21. The protective cover 100 limits the push rod connector 911 and the proximal anchor connector 21 to prevent the push rod connector 911 and the proximal anchor connector 21 from loosening. After the protective cover 100 is removed, the push rod connector 911 can be disengaged from the proximal anchor connector 21 due to the elastic action of the push rod 91.

[0092] Specifically, the push rod connector 911 and the proximal anchor connector 21 are both hollow structures with an S-shaped axial cross-section. After the push rod connector 911 and the proximal anchor connector 21 are radially buckled together, the overall outer surface is cylindrical.

[0093] It should be noted that the axial cross section refers to a cross section parallel to the central axis of the push rod. The push rod connector 911 and the proximal anchor connector 21 are matched in radial concave and convex configurations, so that the entire structure is cylindrical after being fastened. The push rod connector 911 and the proximal anchor connector 21 can slide in the protective sleeve 100 after being fastened to each other. In the present application, the push rod connector 911 and the proximal anchor connector 21 are configured as an S-shaped buckle structure, so that after the push rod connector 911 and the proximal anchor connector 21 are fastened, the connection stability within the protective sleeve 100 is good, which is conducive to the delivery handle 50 to drive the push rod 91 and the proximal anchor 20 to move.

[0094] In one embodiment, see Figure 5 and Figure 6The push rod adjustment assembly 92 includes a push rod knob 921 and a push rod fixing member 922. The push rod fixing member 922 is fixed to the proximal end of the push rod 91. The push rod fixing member 922 is slidably mounted on the delivery handle 50. The push rod knob 921 is rotatably mounted on the delivery handle 50 and is threadedly sleeved on the push rod fixing member 922. When the position of the proximal anchor 20 needs to be adjusted, the push rod knob 921 is rotated on the delivery handle 50. Since the push rod knob 921 and the push rod fixing member 922 are connected by a threaded transmission, the rotation of the push rod knob 921 is converted into the sliding of the push rod fixing member 922 on the delivery handle 50, thereby driving the proximal anchor 20 to move via the push rod 91 to adjust the position of the proximal anchor 20. The present application can adjust the position of the proximal anchor 20 by rotating the push rod knob 921. The adjustment is simple, the transmission is smooth, and the adjustment accuracy is high, which is suitable for adjusting devices implanted in the human body. It is understandable that in other embodiments of the present application, according to actual design conditions and specific requirements, the above-mentioned push rod adjustment assembly 92 can also be of other types, such as a ball screw structure, a gear rack structure, etc., which is not particularly limited here.

[0095] See also Figure 7 The inner diameter of the push rod fixing member 922 matches the outer diameter of the push rod 91. The push rod fixing member 922 is sleeved on the push rod 91 and is fixed to the push rod 91 by glue. A seal 923 is provided between the push rod fixing member 922 and the push rod 91. The seal 923 prevents blood from flowing through the gap between the push rod 91 and the push rod fixing member 922, thereby preventing bleeding.

[0096] Specifically, a sealing groove (not shown) is provided at the proximal center of the push rod fixing member 922. The sealing groove is connected to the inner hole of the push rod fixing member 922. The sealing member 923 is a silicone ring and is accommodated in the sealing groove. The sealing member 923 is sleeved on the outside of the push rod 91 and is locked between the push rod fixing member 922 and the push rod 91 by a machine screw 924, thereby achieving a sealing effect. It is understandable that in other embodiments of the present application, an annular sealing groove can be provided on the inner wall of the push rod fixing member 922, and then the sealing member 923 can be embedded in the sealing groove. The sealing member 923 abuts between the push rod 91 and the push rod fixing member 922, which can also achieve a sealing effect.

[0097] See also Figure 5 and Figure 8 In order to prevent the push rod fixing part 922 from rotating when the push rod knob 921 rotates, a push rod anti-rotation groove 55 is provided in the delivery handle 50, and the push rod fixing part 922 is slidably accommodated in the push rod anti-rotation groove 55, thereby ensuring that during the movement of the push rod 91, the push rod 91 and the proximal anchor 20 can only move without rotating, thereby ensuring the movement safety of the push rod 91 and the proximal anchor 20.

[0098] For details, please refer to Figure 8 The push rod fixing part 922 is T-shaped, and the push rod fixing part 922 includes a connecting part 9221 and an anti-rotation part 9222. The connecting part 9221 is vertically connected to the anti-rotation part 9222. The connecting part 9221 is threadedly connected to the push rod knob 921. The anti-rotation part 9222 is arranged at the proximal end of the connecting part 9221. The shape of the push rod anti-rotation groove 55 is adapted to the shape of the connecting part 9221, so that the push rod fixing part 922 can only move but not rotate.

[0099] See also Figure 5 and Figure 6 The push rod adjustment assembly 92 also includes a push rod locking member 925, which is used to lock the push rod knob 921 after the position of the push rod 91 is adjusted to prevent the push rod knob 921 from rotating incorrectly and causing the push rod 91 to move incorrectly.

[0100] Specifically, a plurality of first slots 9211 are provided on the outer periphery of the distal end of the push rod knob 921, and the plurality of first slots 9211 are evenly distributed along the outer periphery of the push rod knob 921. The push rod locking piece 925 is a locking screw, and the locking screw is threadedly mounted on the delivery handle 50. One end of the locking screw extends from the outside of the delivery handle 50 into the delivery handle 50 and is inserted into one of the first slots 9211, thereby preventing the push rod knob 921 from rotating.

[0101] In one embodiment, see Figure 1 The lock structure 40 includes a lock seat 41, a locking plate 42, and an elastic member 43. The lock seat 41 is fixed to the proximal end of the proximal anchor 20. The locking plate 42 is disposed within the inner cavity of the lock seat 41. The lock wire 30 is disposed through the lock seat 41 and the locking plate 42. The elastic member 43 is disposed within the inner cavity of the lock seat 41. Under normal conditions, the elastic member 43 is elastic, and the locking plate 42 is tilted under the elastic action of the elastic member 43 to retain the lock wire 30. The unlocking member 70 is used to rotate the locking plate 42 to a position perpendicular to the lock wire 30 to release the lock wire 30.

[0102] For details, please refer to Figure 1 When the lock wire 30 is in the correct position, the unlocking member 70 is released, and the lock piece 42 is tilted again and pressed against the lock wire 30 under the elastic force of the elastic member 43.

[0103] In a specific embodiment, the unlocking member 70 is an unlocking rope, the two ends of which are respectively connected to the lock control member 60, and the middle of the unlocking rope passes through the opposite ends of the lock plate 42. The lock control member 60 is used to drive the unlocking rope to pull the lock plate 42 to a perpendicular position with the lock wire 30. In actual operation, please refer to Figure 9 and Figure 10 The lock control member 60 can be pulled on the delivery handle 50 to tighten the middle portion of the unlocking cord, thereby pulling the locking plate 42 to a position perpendicular to the locking wire 30. After the locking wire 30 is positioned properly, the lock control member 60 is loosened. The middle portion of the unlocking cord no longer exerts force on the locking plate 42, and the locking plate 42 tilts under the action of the elastic member 43 to lock the locking wire 30.

[0104] The lock control member 60 controls the unlocking cord by mechanically securing both ends of the unlocking cord to the lock control member 60, and then rotating the lock control member 60 on the delivery handle 50 via a screw thread, thereby tightening or loosening the unlocking cord. It is understood that in other embodiments of the present application, the lock control member 60 may also control the unlocking cord by other means, such as simply pulling.

[0105] In one embodiment, see Figures 5 to 7 The delivery device further includes a protective sleeve 100 and a protective sleeve adjustment assembly 110. The proximal end of the protective sleeve 100 is connected to the protective sleeve adjustment assembly 110, and the distal end of the protective sleeve 100 extends outside the delivery handle 50. The protective sleeve 100 is coaxially sleeved outside the push rod 91, and the push rod 91 is coaxially sleeved outside the core wire 81. The protective sleeve adjustment assembly 110 is installed in the delivery handle 50 and is used to drive the protective sleeve 100 to move. The provision of the protective sleeve 100 can protect the push rod 91, the core wire 81, and the locking wire 30, facilitating the implantation of the push rod 91, the core wire 81, and the locking wire 30 into the human body. In addition, by coaxially arranging the protective sleeve 100, the push rod 91 and the core wire 81, the protective sleeve 100, the push rod 91 and the core wire 81 are all driven along the center, thereby ensuring the stability of the driving of the protective sleeve 100, the push rod 91 and the core wire 81. In addition, the protective sleeve 100, the push rod 91 and the core wire 81 occupy a small space, which is conducive to the human body implantation operation.

[0106] The protective cover 100 is made of a medical intervention polymer material, such as polyethylene (PE).

[0107] See also Figure 11 The protective cover 100 is provided with two wire holes 102, and the unlocking ropes respectively pass through the two wire holes 102. The unlocking rope is guided and carried by the protective cover 100, thereby preventing the unlocking rope from being entangled and the control force from being unstable due to its long length.

[0108] Specifically, the protective cover 100 has a central hole 101 and two thread holes 102, each of which axially extends through opposite ends of the protective cover 100. The central hole 101 is mounted on the push rod 91, and the two thread holes 102 are symmetrically arranged relative to the central hole 101. The two thread holes 102 are respectively used to pass different portions of the unlocking cord, specifically two oppositely arranged sections between the ends and the middle of the unlocking cord. The two symmetrical thread holes 102 allow the two oppositely arranged unlocking cord sections to pass through the opposite ends of the locking plate 42, respectively, and be used to pull and control the opposite ends of the locking plate 42, thereby improving the accuracy of the unlocking cord's control over the locking plate 42.

[0109] In one embodiment, see Figure 5 and Figure 6 The protective sleeve adjustment assembly 110 includes a protective sleeve knob 111 and a protective sleeve fixing member 112. The protective sleeve fixing member 112 is fixed to the proximal end of the protective sleeve 100. The protective sleeve fixing member 112 is slidably arranged in the delivery handle 50. The protective sleeve knob 111 is rotatably arranged on the delivery handle 50, and the protective sleeve knob 111 is threadedly sleeved on the protective sleeve fixing member 112. When the protective sleeve 100 needs to be moved, the protective sleeve knob 111 is rotated on the delivery handle 50. Since the protective sleeve knob 111 and the protective sleeve fixing member 112 are threadedly connected, the rotation of the protective sleeve knob 111 is converted into the sliding of the protective sleeve fixing member 112 on the delivery handle 50, thereby driving the protective sleeve 100 to move. For example, after the implant device is adjusted, the protective sleeve 100 is withdrawn from the human body. The present application can move the protective sleeve 100 by rotating the protective sleeve knob 111. The adjustment is simple, the transmission is smooth, and the adjustment accuracy is high, which is suitable for the operation of the human implant device. It is understandable that in other embodiments of the present application, according to actual design conditions and specific requirements, the protective cover adjustment assembly 110 may also be of other types, such as a ball screw structure, a gear rack structure, etc., which is not particularly limited here.

[0110] The inner diameter of the protective cover fixing member 112 is matched with the outer diameter of the protective cover 100 . The protective cover fixing member 112 is sleeved on the protective cover 100 . The protective cover fixing member 112 and the protective cover 100 are fixedly connected by glue.

[0111] See also Figure 5 In order to prevent the protective cover fixing part 112 from rotating when the protective cover knob 111 rotates, a protective cover anti-rotation groove 56 is provided in the delivery handle 50, and the protective cover fixing part 112 is slidably accommodated in the protective cover anti-rotation groove 56, thereby ensuring that during the movement of the protective cover 100, the protective cover 100 only moves and does not rotate, thereby ensuring the movement safety of the protective cover 100.

[0112] Specifically, the structure and shape of the protective cover fixing member 112 are similar to the shape of the push rod fixing member 922, and the protective cover fixing member 112 is also T-shaped. Similarly, the shape of the protective cover anti-rotation groove 56 is also adapted to the shape of the push rod anti-rotation groove 55, and a repeated description is not given here.

[0113] See also Figure 5 and Figure 6 The protective cover adjustment assembly 110 further includes a protective cover locking member 113 , which is used to lock the protective cover knob 111 after the position of the protective cover 100 is adjusted to prevent the protective cover knob 111 from rotating incorrectly and causing the protective cover 100 to move incorrectly.

[0114] Specifically, a plurality of second slots 1111 are provided on the outer periphery of the distal end of the protective cover knob 111, and the plurality of second slots 1111 are evenly distributed along the outer periphery of the protective cover knob 111. The protective cover locking piece 113 is a locking screw, and the locking screw is threadedly mounted on the delivery handle 50. One end of the locking screw extends from the outside of the delivery handle 50 into the delivery handle 50 and is inserted into one of the second slots 1111, thereby preventing the protective cover knob 111 from rotating.

[0115] See also Figure 6 The delivery handle 50 includes an upper shell 51 and a lower shell 52. The upper shell 51 and the lower shell 52 are both semicircular. The upper shell 51 and the lower shell 52 cover each other and enclose a mounting cavity 53. The push rod knob 921, the push rod fixing piece 922, the protective cover knob 111, the protective cover fixing piece 112 and the core wire knob 821 are all installed in the mounting cavity 53. The protective cover knob 111, the push rod knob 921 and the core wire knob 821 are arranged in sequence along the axial direction of the delivery handle 50. The core wire knob 821 is arranged at the proximal end of the delivery handle 50, and the protective cover knob 111 and the push rod knob 921 are at least partially exposed to the outside of the delivery handle 50 for manual operation.

[0116] In one embodiment, see Figure 12 and Figure 13The delivery device further includes a delivery sheath 120 and a loader 130. The loader 130 is connected between the delivery sheath 120 and the delivery handle 50. The delivery sheath 120 is used to be guided and inserted into the human body. The loader 130 is placed outside the human body. The loader 130 is used to load implantable devices such as the distal anchor 10, the proximal anchor 20, the locking wire 30, and the locking structure 40. The implantable devices such as the distal anchor 10, the proximal anchor 20, the locking wire 30, and the locking structure 40 are loaded into the delivery sheath 120 from the loader 130 and introduced into the human body through the delivery sheath 120. During actual operation, the delivery sheath 120, the loader 130 and the delivery handle 50 are first connected in sequence, and the implant devices such as the distal anchor 10, the proximal anchor 20, the locking wire 30 and the locking structure 40 are loaded into the loader 130. Then the delivery sheath 120 is guided and inserted into the human body, and the distal anchor 10, the proximal anchor 20, the locking wire 30 and the locking structure 40 are implanted into the human body through the delivery sheath 120 through the various driving components on the delivery handle 50. After adjusting the positions of the distal anchor 10, the proximal anchor 20, the locking wire 30 and the locking structure 40, the core wire 81, the push rod 91 and the protective cover 100 are withdrawn through the loader 130 through the various driving components on the delivery handle 50, and finally the delivery sheath 120 is withdrawn from the human body.

[0117] Specifically, the distal end of the delivery sheath 120 is used for introduction into the human body, and the proximal end of the delivery sheath 120 is connected to a Y-valve 121. Both connection ports of the Y-valve 121 are male Luer connectors, one of which is used to deliver auxiliary fluids during implantation surgery. The inner diameter of the loader 130 is adapted to the inner diameter of the delivery sheath 120. The loader 130 has a connector end 131 and a threaded end 132. The connector end 131 is a female Luer connector and is connected to the other male Luer connector of the delivery sheath 120. The threaded end 132 of the loader 130 is provided with an external thread. The distal end of the delivery handle 50 is internally provided with a loader knob 140, and the threaded end 132 of the loader 130 is threadedly connected to the loader knob 140. The loader 130 can be moved by rotating the loader knob 140 , thereby adjusting the relative position of the loader 130 and the delivery handle 50 , so as to facilitate loading the distal anchor 10 , the proximal anchor 20 , the locking wire 30 and the locking structure 40 at appropriate positions in the loader 130 .

[0118] The delivery sheath 120 is a 12F sheath with an inner diameter of approximately 3.4 mm. Its inner layer is made of a low-friction polymer material, such as PTFE membrane. The middle layer is a medical intervention-grade braided metal mesh, such as 304V stainless steel. The outer layer is made of a high-flexure polymer material, such as PEBAX.

[0119] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in this application should be included in the scope of protection of this application. Therefore, the scope of protection of this application should be based on the scope of protection of the claims.

Claims

1. A mitral valve annulation system, characterized in that: including delivery devices and implantation devices; The implant device includes a distal anchor, a proximal anchor, a locking structure, and a locking wire; the distal anchor is used to anchor in the great cardiac vein, the proximal anchor is used to anchor in the coronary sinus, the locking structure is fixed to the proximal end of the proximal anchor, the distal end of the locking wire is fixed to the proximal end of the distal anchor, and the locking wire is arranged through the proximal anchor and the locking structure; The unlocking member of the lock structure is connected to the delivery device, and the proximal end of the lock wire is connected to the delivery device. The delivery device is capable of implanting the distal anchor, the proximal anchor, the lock structure, and the lock wire into a human body; and the delivery device is capable of controlling the opening and closing of the lock structure through the unlocking member to lock or release the lock wire; the delivery device is also capable of driving the lock wire and the distal anchor toward or away from the proximal anchor, thereby adjusting the degree of annulation of the mitral valve by the proximal and distal anchors; The lock structure comprises: a locking seat, fixed to the proximal end of the proximal anchor; A locking piece is arranged in the inner cavity of the lock seat, and the locking wire passes through the locking piece; An elastic member is provided in the inner cavity of the lock seat, and the locking plate is tilted under the elastic action of the elastic member to clamp the lock wire; the unlocking member is used to rotate the locking plate to a state perpendicular to the lock wire to loosen the lock wire.

2. The mitral valve annulation system according to claim 1, wherein: The conveying device comprises: Delivery handle; a lock control member, the lock control member being mounted on the delivery handle, the proximal end of the unlocking member being connected to the lock control member, the lock control member being used to drive the unlocking member to control the opening and closing of the lock structure; A locking wire drive assembly is installed on the conveying handle, the locking wire drive assembly at least partially extends out of the conveying handle to be connected to the locking wire, and the locking wire drive assembly is used to drive the locking wire to move.

3. The mitral valve annulation system according to claim 2, wherein: The lock wire drive assembly includes a core wire and a core wire adjustment assembly. The distal end of the core wire extends outside the delivery handle to form a detachable connection with the proximal end of the lock wire. The proximal end of the core wire is connected to the core wire adjustment assembly. The core wire adjustment assembly is installed in the delivery handle and is used to drive the core wire to move together with the lock wire.

4. The mitral valve annulation system according to claim 3, wherein: The core wire adjustment assembly includes a core wire knob and a core wire fixing structure. The core wire fixing structure is fixedly connected to the proximal end of the core wire. The core wire fixing structure is slidably arranged in the delivery handle. The core wire knob is rotatably arranged in the delivery handle. The core wire knob is threadedly sleeved on the core wire fixing structure.

5. The mitral valve annulation system according to claim 4, characterized in that: The core wire fixing structure includes a first fixing part and a second fixing part. The first fixing part is slidably arranged in the delivery handle, the first fixing part is movably sleeved on the outside of the core wire, the second fixing part is used to fix the core wire on the first fixing part, and the core wire knob is threadedly sleeved on the first fixing part.

6. The mitral valve annulation system according to claim 4, characterized in that: A core wire anti-rotation groove is provided in the delivery handle, and the core wire fixing structure is at least partially slidably accommodated in the core wire anti-rotation groove.

7. The mitral valve annulation system according to claim 3, wherein: The delivery device further comprises a proximal anchor drive assembly installed in the delivery handle; the proximal anchor drive assembly at least partially extends out of the delivery handle to connect with the proximal anchor and is used to drive the proximal anchor to move.

8. The mitral valve annulation system according to claim 7, characterized in that: The proximal anchor drive assembly includes a push rod and a push rod adjustment assembly. The distal end of the push rod forms a detachable connection with the proximal end of the lock structure, and the proximal end of the push rod is connected to the push rod adjustment assembly. The push rod adjustment assembly is installed in the delivery handle and is used to drive the push rod, the lock structure and the proximal anchor to move together.

9. The mitral valve annulation system according to claim 8, characterized in that: The push rod adjustment assembly includes a push rod knob and a push rod fixing piece, the push rod fixing piece is fixed to the proximal end of the push rod, the push rod fixing piece is slidably arranged on the delivery handle, the push rod knob is rotatably arranged on the delivery handle, and the push rod knob is threadedly sleeved on the push rod fixing piece.

10. The mitral valve annulation system according to claim 9, characterized in that: The push rod fixing piece is sleeved on the push rod, and a sealing piece is abutted between the push rod fixing piece and the push rod.

11. The mitral valve annulation system according to claim 9, wherein: A push rod anti-rotation groove is provided in the conveying handle, and the push rod fixing piece is slidably accommodated in the push rod anti-rotation groove.

12. The mitral valve annulation system according to claim 8, wherein: The unlocking member is an unlocking rope, the two ends of which are respectively connected to the lock control member, and the middle part of the unlocking rope passes through the opposite ends of the locking plate respectively. The lock control member is used to drive the unlocking rope to pull the locking plate to a state perpendicular to the lock wire.

13. The mitral valve annulation system according to claim 12, wherein: The conveying device also includes a protective sleeve and a protective sleeve adjustment component; The proximal end of the protective sleeve is connected to the protective sleeve adjustment assembly, the distal end of the protective sleeve extends out of the delivery handle, the protective sleeve is coaxially sleeved outside the push rod, and the push rod is coaxially sleeved outside the core wire; the protective sleeve adjustment assembly is installed in the delivery handle, and the protective sleeve adjustment assembly is used to drive the protective sleeve to move; The protective cover is provided with two wire holes, and the unlocking rope is respectively passed through the two wire holes.

14. The mitral valve annulation system according to claim 13, wherein: The protective cover has a central hole and two wire holes. The central hole is sleeved on the push rod. The two wire holes are symmetrically arranged relative to the central hole. The two wire holes are respectively used for different parts of the unlocking rope to pass through.

15. The mitral valve annulation system according to claim 13, wherein: The protective cover adjustment assembly includes a protective cover knob and a protective cover fixing piece, the protective cover fixing piece is fixed to the proximal end of the protective cover, the protective cover fixing piece is slidably arranged in the delivery handle, the protective cover knob is rotatably arranged on the delivery handle, and the protective cover knob is threadedly sleeved on the protective cover fixing piece.

16. The mitral valve annulation system according to any one of claims 2 to 15, characterized in that: The delivery device also includes a delivery sheath and a loader, and the loader is connected between the delivery sheath and the delivery handle; the delivery sheath is used to guide insertion into the human body, and the loader is used to load the distal anchor, the proximal anchor, the locking wire and the locking structure, and the distal anchor, the proximal anchor, the locking wire and the locking structure are loaded into the delivery sheath from the loader.

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