Mitral valve annulus system

Abstract

The present application provides a mitral valve annulation system, including an implantation device and a delivery 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 delivery device includes a delivery handle and a protective sleeve; the proximal end of the locking wire is connected to the delivery handle, and the unlocking rope of the locking structure is connected to the delivery handle, and the unlocking rope is used to control the opening and closing of the locking structure; the protective sleeve is installed in the delivery handle, and the distal end of the protective sleeve at least partially extends out of the delivery handle and is mounted on at least part of the locking wire, a rope hole is provided on the protective sleeve, and the unlocking rope passes through the rope hole; an anti-rotation structure is provided between the protective sleeve and the locking structure to prevent the protective sleeve and the locking structure from rotating relative to each other, so that the unlocking rope will not be entangled and will not affect the unlocking effect of the unlocking rope on the locking structure.

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 is disclosed. This procedure involves accessing the body through the jugular vein and implanting a device in the coronary sinus and great cardiac vein. The device has two anchors: a distal anchor anchored in the great cardiac vein and a proximal anchor anchored in the coronary sinus, connected by a connector. By tightening the device, inward pressure is applied to the mitral annulus, causing it to contract and essentially restore its normal geometry, thereby tightly closing the mitral valve leaflets and improving mitral regurgitation. However, in existing implantable devices, the distance between the proximal and distal anchors is fixed, and after the device is released from the body, the distance between the proximal and distal anchors cannot be adjusted, meaning the degree of annular contraction cannot be adjusted after release. Summary of the Invention

[0005] 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.

[0006] To solve the above problems, the technical solutions provided in the embodiments of the present application are: a mitral valve annulus contraction system, comprising an implantation device and a delivery device;

[0007] 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;

[0008] The delivery device includes a delivery handle and a protective cover; the proximal end of the locking wire is connected to the delivery handle, and the unlocking rope of the lock structure is connected to the delivery handle, and the unlocking rope is used to control the opening and closing of the lock structure; the protective cover is installed in the delivery handle, and the distal end of the protective cover at least partially extends outside the delivery handle and is sleeved on at least a portion of the locking wire. The protective cover is provided with a rope hole, and the unlocking rope passes through the rope hole;

[0009] An anti-rotation structure is provided between the protective sleeve and the lock structure to prevent the protective sleeve and the lock structure from rotating relative to each other.

[0010] According to the mitral valve annulation system provided in an embodiment of the present application, the unlocking rope of the locking structure is connected to the delivery handle through the setting of the delivery handle, so that the locking and unlocking of the locking structure and the locking wire can be controlled by operating the unlocking rope on the delivery handle, and the proximal end of the locking wire is connected to the delivery handle at the same time. Then, when the locking structure and the locking wire are unlocked, the locking wire can be driven at the delivery handle 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; at the same time, by providing an anti-rotation structure between the protective cover and the locking structure, the anti-rotation structure is used to prevent relative rotation between the protective cover and the locking structure, so that the unlocking rope will not be entangled between the locking structure and the delivery handle, and thus will not affect the unlocking effect of the unlocking rope on the locking structure.

[0011] In a possible design, the anti-rotation structure includes a first anti-rotation portion provided on the lock structure and a second anti-rotation portion provided on the protective cover, and the first anti-rotation portion and the second anti-rotation portion form a circumferential limiting fit.

[0012] In one possible design, the anti-rotation structure includes:

[0013] a convex portion, the convex portion being convexly provided at the proximal end of the locking structure;

[0014] a recess, the recess being formed at a distal end of the protective sleeve;

[0015] The convex portion and the concave portion can form a concave-convex fit.

[0016] In a possible design, the recess is a notch that is axially recessed inward from the distal end of the protective sleeve, and the notch passes through the side wall of the protective sleeve.

[0017] In a possible design, the recess is a groove that is axially recessed inward from the distal end of the protective sleeve, and dimensions of the groove in all directions are smaller than the thickness of the side wall of the protective sleeve.

[0018] In one possible design, the anti-rotation structure includes:

[0019] a recess, the recess being formed at a proximal end of the lock structure;

[0020] a convex portion, the convex portion being convexly provided at the distal end of the protective sleeve;

[0021] The convex portion and the concave portion can form a concave-convex fit.

[0022] In a possible design, the convex portion is cylindrical or regular polyhedron-shaped; the shape of the concave portion matches the shape of the convex portion.

[0023] In a possible design, the number of the convex portions is two, and the two convex portions are symmetrically arranged along the circumference of the protective sleeve; the number of the concave portions is also two, and the two concave portions are arranged in a one-to-one correspondence with the two convex portions.

[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 passes 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 rope 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 delivery device also includes a protective sleeve knob and a protective sleeve fixing piece, the protective sleeve fixing piece is fixed to the proximal end of the protective sleeve, the protective sleeve fixing piece is slidably arranged in the delivery handle, the protective sleeve knob is rotatably arranged on the delivery handle, and the protective sleeve knob is threadedly sleeved on the protective sleeve fixing piece.

[0029] In a possible design, the delivery device further includes a protective cover locking member, which is used to lock the protective cover knob after the position of the protective cover is adjusted.

[0030] In one possible design, the conveying device also includes a push rod, a push rod knob and a push rod fixing piece; the distal end of the push rod forms a detachable connection with the lock structure, 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 conveying handle, the push rod knob is rotatably provided on the conveying handle, and the push rod knob is threadedly sleeved on the push rod fixing piece.

[0031] In a possible design, the conveying device further includes a push rod locking member, which is used to lock the push rod knob after the position of the push rod is adjusted. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] 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.

[0033] 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;

[0034] Figure 2 Schematic diagram of the structure of the delivery device of the mitral valve annulation system provided in an embodiment of the present application;

[0035] Figure 3 is an exploded schematic diagram of a delivery device of a mitral valve annulation system provided in an embodiment of the present application;

[0036] Figure 4 Schematic diagram of the anti-rotation structure between the lock structure and the protective cover in the first embodiment of the present application;

[0037] Figure 5 This is a schematic structural diagram of another anti-rotation structure between the lock structure and the protective cover in the first embodiment of the present application;

[0038] Figure 6 This is a schematic structural diagram of the anti-rotation structure between the lock structure and the protective cover in the second embodiment of the present application;

[0039] Figure 7 This is a schematic structural diagram of the anti-rotation structure between the lock structure and the protective cover in the third embodiment of the present application;

[0040] Figure 8 This is a schematic diagram of the assembly of the lock structure, lock wire, core wire, push rod and protective sleeve in Example 1 of the present application;

[0041] Figure 91 is a schematic diagram of the assembly of the push rod, push rod knob, push rod fixing member and push rod locking member in the first embodiment of the present application;

[0042] Figure 10 yes Figure 2 Schematic diagram of the structure of the protective cover.

[0043] Reference numerals: 10, distal anchor; 20, proximal anchor; 30, locking wire; 40, locking structure; 41, lock 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 sleeve anti-rotation groove; 60, lock control member; 70, unlocking rope; 81, core wire; 821, core wire knob; 8221 , first fixing member; 8222, second fixing member; 91, push rod; 921, push rod knob; 9211, first slot; 922, push rod fixing member; 925, push rod locking member; 100, protective cover; 101, center hole; 102, wire hole; 111, protective cover knob; 112, protective cover fixing member; 113, protective cover locking member; 120, anti-rotation structure; 121, convex portion; 122, concave portion. DETAILED DESCRIPTION

[0044] 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.

[0045] 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.

[0046] 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.

[0047] In the description of this application, it should be understood that the terms "inside", "outside", "upper", "bottom", "front", "back" and the like indicate directions or positional relationships (if any) based on the attached Figure 1 The orientation or positional relationship shown is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as a limitation on this application.

[0048] 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.

[0049] like Figure 1 Due to the specific structure of cardiac tissue, the coronary sinus and great cardiac vein are primarily vessels surrounding the mitral valve annulus, making them an ideal candidate for indirect annuloplasty. For ease of explanation in the following detailed description, the term "distal" refers to the direction of insertion into the patient's body, and similarly, the term "proximal" refers to the direction of removal from the patient's body.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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 and is provided with an unlocking rope 70 for controlling the opening and closing of the lock structure 40. The distal end of the lock wire 30 is fixed to the proximal end of the distal anchor 10, and the lock wire 30 is sequentially arranged through the proximal anchor 20 and the lock structure 40. When the lock structure 40 is in the closed state, the lock structure 40 locks the lock wire 30, that is, prevents relative sliding between the lock wire 30 and the lock structure 40. When the lock structure 40 is in the open state, the lock structure 40 releases the lock wire 30, allowing relative sliding between the lock wire 30 and the lock structure 40, that is, allowing relative sliding between the proximal anchor 20 and the distal anchor 10.

[0056] See also Figure 2 and Figure 3 The delivery device includes a delivery handle 50 and a protective sleeve 100. The proximal end of the locking wire 30 is connected to the delivery handle 50, and the unlocking cord 70 of the lock structure 40 is connected to the delivery handle 50. The protective sleeve 100 is mounted on the delivery handle 50. The distal end of the protective sleeve 100 at least partially extends outside the delivery handle 50 and is positioned over at least a portion of the locking wire 30. The protective sleeve 100 has a thread hole 102 formed in the protective sleeve 102, through which the unlocking cord 70 passes. In other words, the protective sleeve 100 protects and guides the unlocking cord 70, preventing it from becoming entangled and affecting the unlocking effect.

[0057] When the distal anchor 10, proximal anchor 20, lock structure 40, and lock wire 30 are implanted in the human body, at least a portion of the protective sheath 100 is also inserted into the human body. During delivery, the distal anchor 10 and proximal anchor 20 need to be adjusted in a nearly horizontal direction, which can easily cause relative rotation between the protective sheath 100 and the lock structure 40. This can cause the unlocking cord 70 to become entangled with the locking joint, resulting in the unlocking cord 70 losing control of unlocking the lock structure 40.

[0058] To address this issue, the present application provides an anti-rotation structure 120 between the protective cover 100 and the lock structure 40. The anti-rotation structure 120 is used to prevent relative rotation between the protective cover 100 and the lock structure 40, thereby preventing the unlocking cord 70 from becoming entangled in the lock joint. It is understood that the anti-rotation structure 120 can be provided between the protective cover 100 and the lock structure 40, or can be provided on each of the protective cover 100 and the lock structure 40.

[0059] The mitral valve annulation system of the present application connects the unlocking rope 70 of the lock structure 40 to the delivery handle 50 through the setting of the delivery handle 50, so that the locking and unlocking of the lock structure 40 and the lock wire 30 can be controlled by operating the unlocking rope 70 on the delivery handle 50. At the same time, the proximal end of the lock wire 30 is connected to the delivery handle 50. When the lock structure 40 and the lock wire 30 are unlocked, the lock wire 30 can be driven at the delivery handle 50 to drive the distal anchor 10 to move closer to or away from the proximal anchor 20, thereby achieving the distal anchor 10 and the proximal anchor 20. The relative positions of the anchors 20 are adjusted, and then the degree of contraction of the mitral valve by the proximal anchor 20 and the distal anchor 10 is adjusted to achieve a better contraction effect; at the same time, an anti-rotation structure 120 is provided between the protective cover 100 and the locking structure 40, and the anti-rotation structure 120 is used to prevent relative rotation between the protective cover 100 and the locking structure 40, so that the unlocking rope 70 will not be entangled between the locking structure 40 and the delivery handle 50, and thus will not affect the unlocking effect of the unlocking rope 70 on the locking structure 40.

[0060] In one embodiment, the anti-rotation structure 120 includes a first anti-rotation portion and a second anti-rotation portion. The first anti-rotation portion is provided on the lock structure 40, and the second anti-rotation portion is provided on the protective cover 100. The first anti-rotation portion and the second anti-rotation portion form a circumferential limit, thereby preventing relative rotation between the protective cover 100 and the lock structure 40. It is understood that in other embodiments of the present application, the anti-rotation structure 120 can also be in other situations. For example, the first anti-rotation portion is provided on the protective cover 100, and the second anti-rotation portion is provided on the lock structure 40; in another example, the anti-rotation structure 120 is provided between the lock structure 40 and the protective cover 100, and the first anti-rotation portion forms a circumferential limit with the lock structure 40, and the second anti-rotation portion forms a circumferential limit with the protective cover 100; in another example, the first anti-rotation portion and the second anti-rotation portion form not only a circumferential limit but also an axial limit, which is not particularly limited here.

[0061] In a specific embodiment, see Figure 4 The anti-rotation structure 120 includes a convex portion 121 and a concave portion 122. The convex portion 121 is convexly provided at the proximal end of the lock structure 40, and the concave portion 122 is opened at the distal end of the protective cover 100. The convex portion 121 and the concave portion 122 can form a concave-convex fit. Through the concave-convex plug-in fit, a circumferential limit is formed between the lock structure 40 and the protective cover 100, thereby preventing relative rotation between the lock structure 40 and the protective cover 100. The anti-rotation structure 120 is simple, easy to manufacture, and has a good anti-rotation effect.

[0062] Preferably, the recess 122 is a notch that is axially recessed inward from the distal end of the protective cover 100 and extends through the sidewall of the protective cover 100. In other words, the radial thickness of the notch is the same as the radial thickness of the protective cover 100. This design facilitates the processing and forming of the recess 122, that is, the notch can be processed from the side of the protective cover 100.

[0063] The convex portion 121 may be cylindrical or in the shape of a regular polyhedron, wherein the regular polyhedron may be in the shape of a cuboid, a cube, or the like.

[0064] For example Figure 4 In the embodiment, the convex portion 121 is in the shape of a rectangular parallelepiped, and the inner wall of the convex portion 121 is arc-shaped and matches the inner wall of the protective cover 100 , and the shape of the concave portion 122 matches the shape of the convex portion 121 . During installation, the convex portion 121 can be inserted into the concave portion 122 .

[0065] Another example Figure 5 In the embodiment, the convex portion 121 is cylindrical, and the diameter of the convex portion 121 is adapted to the wall thickness of the protective cover 100, and the width of the concave portion 122 along the circumferential direction is adapted to the diameter of the convex portion 121. When the convex portion 121 is inserted into the concave portion 122, the two inner walls of the concave portion 122 along the circumferential direction respectively abut against the outer periphery of the convex portion 121, thereby forming a circumferential limit for the protective cover 100 and the lock structure 40.

[0066] The number of protrusions 121 can be one or more. For example, when there are two protrusions 121, the two protrusions 121 are symmetrically arranged along the circumference of the protective cover 100. Similarly, the number of recesses 122 is also two, and the two recesses 122 are arranged in a one-to-one correspondence with the two protrusions 121. The two protrusions 121 and the two recesses 122 form a plug-in fit, thereby making the connection between the protective cover 100 and the lock structure 40 more stable and secure along the circumference, and facilitating the prevention of relative rotation between the protective cover 100 and the lock structure 40. It is understood that when there is only one protrusion 121, the protrusion 121 can be located at any position along the circumference of the protective cover 100. When there are three or more protrusions 121, the protrusions 121 are evenly distributed along the circumference of the protective cover 100.

[0067] In one embodiment, see Figure 1 The lock structure 40 includes a lock base 41, a locking plate 42, and an elastic member 43. The lock base 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 base 41. The lock wire 30 is disposed through the lock base 41 and the locking plate 42. The elastic member 43 is disposed within the inner cavity of the lock base 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 rope 70 is used to rotate the locking plate 42 to a position perpendicular to the lock wire 30 to release the lock wire 30.

[0068] See also Figure 2 and Figure 3 The transport handle 50 is provided with a lock control member 60. The two ends of an unlocking cord 70 are connected to the lock control member 60. The middle portion of the unlocking cord 70 passes through the opposite ends of the locking plate 42. The lock control member 60 is used to drive the unlocking cord 70 to pull the locking plate 42 to a position perpendicular to the locking wire 30. In actual operation, the lock control member 60 can be pulled on the transport handle 50 to tighten the middle portion of the unlocking cord 70, thereby pulling the locking plate 42 to a position perpendicular to the locking wire 30. After the locking wire 30 is properly positioned, the lock control member 60 is loosened. The middle portion of the unlocking cord 70 no longer exerts force on the locking plate 42, and the locking plate 42 tilts under the action of the elastic member 43 to engage the locking wire 30.

[0069] See also Figure 2 、 Figure 3 and Figure 8 The delivery device also includes a core wire 81, a core wire knob 821, a first fixing member 8221 and a second fixing member 8222. The distal end of the core wire 81 is detachably connected to the proximal end of the lock wire 30. The first fixing member 8221 is movably sleeved on the proximal end 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 about 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 locking wire 30 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 locking wire 30 and the distal anchor 10 can be adjusted by pulling the second fixing member 8222.

[0070] See also Figure 5 and Figure 6 In order to prevent the core wire knob 821 from rotating and causing the first fixing member 8221 to rotate, a core wire anti-rotation groove 54 is provided in the delivery handle 50, and the first fixing member 8221 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.

[0071] See also Figure 2 、 Figure 3 、 Figure 8 and Figure 9 The delivery device further includes a push rod 91, a push rod knob 921, and a push rod fixing member 922. The distal end of the push rod 91 is detachably connected to the proximal end of the lock structure 40. 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 threadedly connected, 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. In the present application, the position of the proximal anchor 20 can be adjusted 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 the adjustment of human implant devices.

[0072] See also Figure 3 and Figure 9 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.

[0073] 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.

[0074] See also Figure 2In 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.

[0075] See also Figure 2 and Figure 3 The delivery device also 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 stable, 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.

[0076] For details, please refer to Figure 10 The protective sleeve 100 has a central hole 101 and two thread holes 102, each of which axially extends through opposite ends of the protective sleeve 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 through different parts of the unlocking cord 70, specifically the two oppositely arranged sections between the ends and the middle of the unlocking cord 70. The two symmetrical thread holes 102 allow the two oppositely arranged sections of the unlocking cord 70 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.

[0077] See also Figure 2In 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.

[0078] See also Figure 2 and Figure 3 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.

[0079] 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.

[0080] See also Figure 3 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.

[0081] Example 2:

[0082] The technical features of the mitral valve annulus system in this embodiment are basically the same as those of the mitral valve annulus system in the embodiment, the difference being that: Figure 6 The recess 122 is a groove axially inwardly recessed from the distal end of the protective sleeve 100, and the dimensions of the groove in all directions are smaller than the thickness of the side wall of the protective sleeve 100, that is, the groove is formed on the side wall of the protective sleeve 100, and the groove needs to be processed axially from the distal end of the protective sleeve 100 during processing.

[0083] The convex portion 121 is cylindrical, and the concave portion 122 is a cylindrical hole. In other embodiments, the convex portion 121 may also be in the shape of a regular polyhedron, wherein the regular polyhedron may be a rectangular parallelepiped, a cube, or the like.

[0084] The number of protrusions 121 can be one or more. For example, when there are two protrusions 121, the two protrusions 121 are symmetrically arranged along the circumference of the protective cover 100. Similarly, the number of recesses 122 is also two, and the two recesses 122 are arranged in a one-to-one correspondence with the two protrusions 121. The two protrusions 121 and the two recesses 122 form a plug-in fit, thereby making the connection between the protective cover 100 and the lock structure 40 more stable and secure along the circumference, and facilitating the prevention of relative rotation between the protective cover 100 and the lock structure 40. It is understood that when there is only one protrusion 121, the protrusion 121 can be located at any position along the circumference of the protective cover 100. When there are three or more protrusions 121, the protrusions 121 are evenly distributed along the circumference of the protective cover 100.

[0085] Example 3:

[0086] The technical features of the mitral valve annulus system in this embodiment are basically the same as those of the mitral valve annulus system in the embodiment, the difference being that: Figure 7 The anti-rotation structure 120 also includes a convex portion 121 and a concave portion 122. The difference is that the convex portion 121 is protruding from the distal end of the protective sleeve 100, and the concave portion 122 is opened at the proximal end of the lock structure 40. The convex portion 121 and the concave portion 122 can form a concave-convex fit to form a circumferential limit between the lock structure 40 and the protective sleeve 100, thereby preventing relative rotation between the lock structure 40 and the protective sleeve 100.

[0087] The convex portion 121 may be cylindrical or in the shape of a regular polyhedron, wherein the regular polyhedron may be in the shape of a cuboid, a cube, or the like.

[0088] The number of protrusions 121 can be one or more. For example, when there are two protrusions 121, the two protrusions 121 are symmetrically arranged along the circumference of the protective cover 100. Similarly, the number of recesses 122 is also two, and the two recesses 122 are arranged in a one-to-one correspondence with the two protrusions 121. The two protrusions 121 and the two recesses 122 form a plug-in fit, thereby making the connection between the protective cover 100 and the lock structure 40 more stable and secure along the circumference, and facilitating the prevention of relative rotation between the protective cover 100 and the lock structure 40. It is understood that when there is only one protrusion 121, the protrusion 121 can be located at any position along the circumference of the protective cover 100. When there are three or more protrusions 121, the protrusions 121 are evenly distributed along the circumference of the protective cover 100.

[0089] 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 implant devices and delivery 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 delivery device includes a delivery handle and a protective cover; the proximal end of the locking wire is connected to the delivery handle, and the unlocking rope of the lock structure is connected to the delivery handle, and the unlocking rope is used to control the opening and closing of the lock structure to lock or unlock the locking wire; the protective cover is installed in the delivery handle, and the distal end of the protective cover at least partially extends out of the delivery handle and is sleeved on at least a portion of the locking wire, and a rope hole is opened on the protective cover, and the unlocking rope passes through the rope hole. When the lock structure and the locking wire are unlocked, the locking rope is driven at the delivery handle to move the distal anchor closer to or away from the proximal anchor; An anti-rotation structure is provided between the protective sleeve and the lock structure to prevent the protective sleeve and the lock structure from rotating relative to each other; 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 is arranged 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 rope 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 anti-rotation structure includes a first anti-rotation portion provided on the lock structure and a second anti-rotation portion provided on the protective cover, and the first anti-rotation portion and the second anti-rotation portion form a circumferential limiting fit.

3. The mitral valve annulation system according to claim 1, wherein: The anti-rotation structure comprises: a convex portion, the convex portion being convexly provided at the proximal end of the locking structure; a recess, the recess being formed at a distal end of the protective sleeve; The convex portion and the concave portion can form a concave-convex fit.

4. The mitral valve annulation system according to claim 3, wherein: The recess is a notch that is axially recessed inward from the distal end of the protective sleeve, and the notch passes through the side wall of the protective sleeve.

5. The mitral valve annulation system according to claim 3, wherein: The recess is a groove that is axially recessed inward from the distal end of the protective sleeve, and dimensions of the groove in all directions are smaller than the thickness of the side wall of the protective sleeve.

6. The mitral valve annulation system according to claim 1, wherein: The anti-rotation structure comprises: a recess, the recess being formed at a proximal end of the lock structure; a convex portion, the convex portion being convexly provided at the distal end of the protective sleeve; The convex portion and the concave portion can form a concave-convex fit.

7. The mitral valve annulation system according to any one of claims 4 to 6, characterized in that: The convex portion is cylindrical or regular polyhedron-shaped; the shape of the concave portion is adapted to the shape of the convex portion.

8. The mitral valve annulation system according to claim 7, wherein: There are two convex portions, and the two convex portions are symmetrically arranged along the circumference of the protective sleeve; there are also two concave portions, and the two concave portions are arranged in a one-to-one correspondence with the two convex portions.

9. The mitral valve annulation system according to claim 1, wherein: The delivery device also includes a protective sleeve knob and a protective sleeve fixing piece, the protective sleeve fixing piece is fixed to the proximal end of the protective sleeve, the protective sleeve fixing piece is slidably arranged in the delivery handle, the protective sleeve knob is rotatably arranged on the delivery handle, and the protective sleeve knob is threadedly sleeved on the protective sleeve fixing piece.

10. The mitral valve annulation system according to claim 9, characterized in that: The delivery device further comprises a protective cover locking member, which is used to lock the protective cover knob after the position of the protective cover is adjusted.

11. The mitral valve annulation system according to claim 1, wherein: The conveying device also includes a push rod, a push rod knob and a push rod fixing piece; the distal end of the push rod forms a detachable connection with the lock structure, 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 conveying handle, the push rod knob is rotatably arranged on the conveying handle, and the push rod knob is threadedly sleeved on the push rod fixing piece.

12. The mitral valve annulation system according to claim 11, wherein: The conveying device further comprises a push rod locking member, which is used to lock the push rod knob after the position of the push rod is adjusted.

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