Outer clip for mitral clip

Abstract

The application discloses an outer clamp for a mitral valve clamp, which comprises an outer clamp base end located at a proximal end, two non-deformable proximal arms symmetrically and integrally extended from two sides of the outer clamp base end towards a distal end, and two deformable distal arms symmetrically and integrally extended from distal ends of the non-deformable proximal arms towards the distal end. The outer clamp arms of the outer clamp can be bent into a three-section structure under the action of a clamping shaft and first and second base plates, the outer clamp arms of the three-section structure are bent to open two large angles, and the opening of the two large angles can provide an opening basis for capturing native valve leaflets.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an external clip for a mitral valve clamp. Background Technology

[0002] In the cardiovascular system, natural heart valves (such as the aortic, pulmonary, mitral, and tricuspid valves) play a crucial role in ensuring a proper and positive flow of blood. However, these valves can be damaged by congenital malformations, inflammatory processes, infectious conditions, or diseases, thereby reducing their efficiency. These disease processes include degenerative processes (such as Barlow's disease or fibroelastosis), inflammatory processes (such as rheumatic heart disease), and infectious processes (such as endocarditis). Additionally, damage to the left or right ventricle from pre-heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (such as cardiomyopathy) can distort the geometry of natural valves, leading to their dysfunction. The vast majority of patients undergoing valve surgery, such as mitral valve surgery, have degenerative diseases that cause dysfunction of the leaflets of natural valves, such as the mitral valve, resulting in prolapse and regurgitation.

[0003] Taking the mitral valve as an example, mitral regurgitation can be caused by a variety of different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the valve cords connecting the leaflets to the papillary muscles, or the papillary muscles themselves, or the left ventricular wall, may be damaged or otherwise dysfunctional. Typically, the valve annulus may be damaged, swollen, or weakened, thus limiting the mitral valve's ability to fully close against greater pressures from the left ventricle; this damage can lead to serious cardiovascular injury or death.

[0004] For many years, the definitive treatment for such damaged valves has been surgical repair or replacement during open-heart surgery. However, due to the relatively small space within the heart compared to the outside, and the fact that most clamps rely on material elasticity for fixation, the elastic deformation process of these clamps is unstable and can potentially cause secondary injury to the patient. Specifically, most existing clamps use a double-hinged structure where the proximal end of the outer clamp arm is hinged to the proximal end of the base plate, and the distal end of the base plate is hinged to the distal end of the inner clamp. In this double-hinged structure, the clamping of the heart valve leaflets relies on the elasticity of the outer clamp during opening and closing of the base plate. Furthermore, the two side arms of the inner clamp also deform due to elastic force. Therefore, the opening and closing process of the base plate follows an uncertain and unpredictable trajectory, making it particularly unstable. Sometimes, sudden elastic abrupt changes can occur, causing the base plate to clamp rapidly and injure the patient. The entire elastic deformation process of the clamp is uncontrollable and unstable, easily causing secondary injury to the patient. Summary of the Invention

[0005] The present invention addresses the technical problem in the prior art where the double hinge structure between the proximal and distal ends of the substrate, outer clamp, and inner clamp causes unstable deformation of the clamp during opening and closing. The purpose is to provide a mitral valve clamp with stable and controllable deformation.

[0006] The mitral valve clamp of the present invention has:

[0007] An inner clamp has a first inner clamp arm and a second inner clamp arm that are symmetrically arranged along the axis and integrally connected at their distal ends;

[0008] A first substrate and a second substrate, wherein the proximal ends of the first substrate and the second substrate are respectively hinged to the proximal ends of the first inner clamping arm and the second inner clamping arm.

[0009] A first clip and a second clip have a fixed piece and a movable piece that are integrally connected at their proximal ends. The fixed pieces of the first clip and the second clip are respectively fixed to the inner sidewalls of the first substrate and the second substrate. The distal ends of the movable pieces of the first clip and the second clip can be pulled and connected to the distal ends of the first inner clamping arm and the second inner clamping arm, respectively.

[0010] An outer clamp has two outer clamp arms that are symmetrically arranged along the axis and integrally connected at their proximal ends. The inner sidewalls of the two outer clamp arms are respectively attached and fixed to the outer sidewalls of the first substrate and the second substrate.

[0011] Preferably,

[0012] The mitral valve clamp has an inner rod that passes through the distal end of the inner clamp along the axis, and the distal section of the inner rod has an engaging section.

[0013] The proximal ends of the first substrate and the second substrate are respectively engagement ends, and the engagement ends are engaged with the engagement section of the inner rod.

[0014] Preferably, a coaxial square post is integrally formed on the outer surface of the distal section of the inner rod, and the engaging section is located on the square post.

[0015] Preferably,

[0016] The meshing section of the square column has a first rack and a second rack facing away from each other. The teeth and grooves of the first rack and the second rack are perpendicular to the axial direction of the inner rod and are arranged parallel to each other along the length direction of the square column surface.

[0017] The meshing ends of the first substrate and the second substrate are gears, and the teeth and grooves of the gears are perpendicular to the axial direction of the inner rod. The gears of the first substrate and the second substrate are respectively able to reciprocate and mesh with the first rack and the second rack of the square column.

[0018] Preferably,

[0019] The first rack and the second rack are located at the far end of the square column, and the far ends of the first rack and the second rack are close to the far end of the square column. The height of the teeth of the first rack and the second rack is flush with the surface of the near end of the square column, and the bottom of the tooth grooves of the first rack and the second rack is flush with the surface of the inner rod.

[0020] Preferably,

[0021] The gear is a half gear with teeth on one half of its side surface.

[0022] Preferably,

[0023] The first and second racks have the same module as the gears at the meshing ends of the first and second substrates, respectively, and the tooth heights of the first and second racks are less than the tooth heights of the gears at the meshing ends. Preferably, the bodies of the meshing ends of the first and second substrates are cylindrical, the axial direction of the meshing end is perpendicular to the inner rod, the side surface of the meshing end has racks or grooves spaced circumferentially along the meshing end, and the axis of the meshing end has a through hinge hole.

[0024] Preferably, the first substrate and the second substrate each have the engagement end, a flat plate segment and a connecting segment, and the two ends of the connecting segment are integrally connected to the engagement end and the flat plate segment, respectively.

[0025] Preferably, the width of the meshing end is smaller than the width of the plate segment; the width of the proximal end of the connecting segment is the same as the width of the meshing end, the width of the distal end of the connecting segment is the same as the width of the plate segment, and the width of the connecting segment increases continuously and smoothly from the proximal end to the distal end.

[0026] Preferably, the proximal section of the inner rod has a delivery external thread, and the proximal end of the outer clamp has a delivery internal thread, which is connected by the delivery external thread and the delivery internal thread, and the proximal section of the inner rod passes through the proximal end of the outer clamp;

[0027] The distal end of the inner clamp has a rod hole, and the distal end of the inner rod passes through the rod hole of the inner clamp.

[0028] Preferably, the mitral valve clamp further comprises:

[0029] A first hinge shaft and a second hinge shaft are respectively inserted into the hinge holes at the meshing ends of the first substrate and the second substrate.

[0030] Two limiting members are provided, with the two ends of the first hinge shaft respectively movably passing through one end of the two limiting members, and the two ends of the second hinge shaft respectively movably passing through the other end of the two limiting members.

[0031] Preferably, the limiting member is a limiting plate.

[0032] One end of each of the two limiting plates is provided with a circular hole, and the two ends of the first hinge shaft are respectively movably inserted into the circular holes of the two limiting plates.

[0033] The other end of the two limiting plates is provided with an oblong hole, and the two ends of the second hinge shaft are respectively movably inserted into the oblong holes of the two limiting plates.

[0034] Preferably, the limiting member is a limiting plate.

[0035] One end of each of the two limiting plates is provided with an oblong hole, and the two ends of the first hinge shaft are respectively movably inserted into the oblong holes of the two limiting plates.

[0036] The other end of the two limiting plates is provided with a circular hole, and the two ends of the second hinge shaft are respectively movably inserted into the circular holes of the two limiting plates.

[0037] Preferably, the distal ends of the first substrate and the second substrate have a U-shaped bend.

[0038] Preferably, the distal ends of the first substrate and the second substrate have a protrusion facing inward.

[0039] Preferably, the outer clip has:

[0040] One external clamping end, located at the proximal end;

[0041] The two outer clamping arms extend symmetrically from both sides of the outer clamping seat end toward the distal end as a single unit.

[0042] Preferably, the outer clamping arm has:

[0043] A non-deformable proximal arm extends integrally from one side of the outer clamp end toward the distal end;

[0044] A deformable distal arm extends integrally from the distal end of the non-deformable proximal arm toward the distal end.

[0045] Preferably, the deformable distal arm has the following characteristics from proximal to distal end:

[0046] A bendable proximal segment extends integrally from the distal end of the non-deformable proximal arm;

[0047] A bendable middle section extends integrally from the distal end of the bendable near section;

[0048] A bendable distal section extends integrally from the distal end of the bendable middle section;

[0049] The angle θ formed by the bendable near segment and the bendable far segment is between 60° and 200°. Preferably, the angle θ formed by the bendable near segment and the bendable far segment is between 90° and 190°.

[0050] In one example, the widths of the bendable proximal section, the bendable middle section, and the bendable distal section are consistent with the width of the non-deformable proximal arm.

[0051] Preferably,

[0052] The width of the bendable proximal section is the same as the width of the non-deformable proximal arm;

[0053] The width of the proximal end of the bendable middle section is the same as the width of the bendable proximal section, and the width of the bendable middle section gradually narrows from the proximal end to the distal end.

[0054] The width of the far end of the bendable section is the same as the width of the far end of the bendable middle section.

[0055] Preferably,

[0056] The distal portions of the first substrate and the second substrate each have at least one substrate fixing hole;

[0057] The first clip and the second clip each have at least one corresponding clip fixing hole on their fixing plates;

[0058] The distal sections of the two outer clamping arms each have at least one corresponding clamping arm fixing hole;

[0059] By sequentially passing a fixing rod through the corresponding clamp fixing hole, the substrate fixing hole, and the clamp arm fixing hole, the fixing pieces of the first clamp and the second clamp, the distal sections of the first substrate and the second substrate, and the distal sections of the two outer clamp arms are respectively fixedly connected together.

[0060] Preferably, the non-deformable proximal arm has a mounting base extending from the side wall of the non-deformable proximal arm. Preferably, the mounting base extends from the inner side wall of the non-deformable proximal arm.

[0061] Preferably, the mounting base has at least one mounting hole.

[0062] Preferably, the outer clip further includes a retracting assembly, the retracting assembly having:

[0063] Two pairs of clamping shafts are respectively clamped on the inner and outer side walls of the deformable distal arm of the two outer clamping arms;

[0064] A pair of parallel seat cover plates are respectively installed on both sides of the non-deformable proximal arm of the two outer clamping arms. Each side of the seat cover plate has a sliding hole at its far end corner. The inner diameter of the sliding hole gradually increases from the outer side to the inner side. The two ends of each pair of clamping shafts are slidably installed in the sliding hole in a manner that tends to slide inward, thereby clamping and retracting the outer clamp.

[0065] Preferably, the sliding hole is L-shaped and has the following characteristics:

[0066] A proximal end hole, wherein the proximal end of the proximal end hole is located on the inner side and the distal end of the proximal end hole is located on the outer side;

[0067] A distal hole, wherein the proximal end of the distal hole is connected to the distal end of the proximal hole, the proximal end of the distal hole is located on the outer side, and the distal end of the distal hole is located on the inner side.

[0068] Preferably,

[0069] The distance between the proximal holes gradually increases from the inside to the outside;

[0070] The distance between the distal holes gradually increases from the outside to the inside, and the maximum distance between the distal holes on the inside is equal to the diameter of the clamping shaft; such that the clamping shaft tends to slide inward, thereby clamping and retracting the outer clamp.

[0071] Preferably,

[0072] The included angle β formed by the two sides of the proximal hole is 3° to 10°;

[0073] The included angle α formed by the two sides of the distal hole is 1° to 5°.

[0074] Preferably,

[0075] The angle γ formed by the centerline of the proximal orifice and the axis of the mitral valve clamp is 15° to 25°.

[0076] The angle δ formed by the centerline of the distal orifice and the axis of the mitral valve clamp is 60° to 70°.

[0077] Preferably, both ends of the clamping shaft have anti-dislodgement caps.

[0078] Preferably, the proximal corners on both sides of the seat cover plate each have at least one fixing hole for mounting the seat cover plate onto the two outer clamping arms.

[0079] Preferably, the seat cover is trapezoidal in shape, with the proximal side of the seat cover being smaller than the distal side.

[0080] Preferably, the distal side of the seat cover is concave arc-shaped.

[0081] Preferably, the seat cover plate has at least one fixing hole on each of its proximal corners;

[0082] The side wall of the non-deformable proximal arm has a mounting base, and the mounting base has at least one mounting hole corresponding to the position of the fixing hole;

[0083] The mounting plate is installed on both sides of the mounting base by means of a mounting rod passing through the fixing hole and the mounting hole.

[0084] Preferably, the deformable distal arm has, from proximal end to distal end, a bendable proximal section, a bendable middle section, and a bendable distal section.

[0085] The clamping shafts abut against the inner and outer walls of the bendable middle section, respectively. The clamping shafts provide a fulcrum to support the bending deformation of the deformable distal arm, so that the included angle θ formed by the bending of the deformable distal arm is between 60° and 200°, preferably between 90° and 190°.

[0086] Preferably, the mitral valve clamp further comprises:

[0087] Two petal-shaped outer frames are located on the outer sides of the outer clamping arm, and the proximal ends of the petal-shaped outer frames are two opposing mounting rods. The mounting rods are sequentially inserted into the fixing holes on the seat cover plate and the mounting holes of the mounting base of the non-deformable proximal arm.

[0088] Preferably, the mitral valve clamp further comprises:

[0089] Two films are used to cover the outer frame of the petals and the corresponding outer clamping arms together.

[0090] Preferably, the inner clip has:

[0091] The inner clamping end is located at the distal end;

[0092] The first inner clamping arm and the second inner clamping arm extend integrally from both sides of the inner clamping seat end toward the proximal end, respectively;

[0093] The two first hinge ends and the two second hinge ends are cylindrical and integrally formed on both sides of the proximal end of the first inner clamping arm and the second inner clamping arm body, respectively hinged to the meshing ends of the first substrate and the second substrate.

[0094] Preferably,

[0095] The two first hinge ends and the two second hinge ends each have a hinge hole at their axis, and the meshing ends of the first substrate and the second substrate also have hinge holes.

[0096] A first hinge shaft passes through the hinge holes of the two first hinge ends and the hinge hole of the meshing end of the first substrate. The meshing end of the first substrate is located in the middle of the two first hinge ends, and the proximal end of the first substrate and the proximal end of the first inner clamping arm are hinged together.

[0097] A second hinge shaft passes through the hinge holes of the two second hinge ends and the hinge hole of the meshing end of the second substrate. The meshing end of the second substrate is located in the middle of the two second hinge ends, and the proximal end of the second substrate and the proximal end of the second inner clamping arm are hinged together.

[0098] Preferably, the inner clamping end is U-shaped and has an axial rod hole, and the distal end of the inner rod passes through the rod hole of the inner clamping end.

[0099] Preferably, the distal end of the inner clamping seat is integrally connected to a block end, and the rod hole extends through the block end.

[0100] Preferably, the first clip and the second clip are each a long sheet body;

[0101] The movable piece of the first clip and the second clip is a long frame body with a small piece cut out from the middle of the large piece;

[0102] The fixing piece of the first clip and the second clip is the small piece that has been hollowed out;

[0103] The near end of the hollowed-out portion of the long frame is connected to the near end of the small piece.

[0104] Preferably,

[0105] The long sheet has a double-layer structure, and the long frame and the small sheet also have a double-layer structure.

[0106] The long frame has several barbs cut out in the same direction on one layer facing the first substrate and the second substrate.

[0107] Preferably,

[0108] The distal ends of the first substrate and the second substrate have a first operating hole for the first pull wire to pass through;

[0109] The distal ends of the first inner clamping arm and the second inner clamping arm have a second operating hole for the second pull wire to pass through;

[0110] The distal ends of the movable pieces of the first and second clamping pieces have clamping operation holes for the passage of the second pull line. The distal ends of the first inner clamping arm and the second inner clamping arm can be pulled and connected to the distal ends of the movable pieces of the first and second clamping pieces respectively by passing the second pull line through them.

[0111] In view of the mitral valve clamp of the present invention, another object of the present invention is to provide an outer clamp for the mitral valve clamp. The outer clamp arm of the present invention can be bent into a three-section structure under the action of the clamping shaft and the first and second base plates. The three-section structure of the outer clamp arm is bent into two large angles, which can provide an opening basis for capturing the original leaflet.

[0112] An external clamp for a mitral valve clamp, characterized by having:

[0113] One external clamping end, located at the proximal end;

[0114] Two non-deformable proximal arms extend symmetrically from both sides of the outer clamp end toward the distal end in one piece;

[0115] Two deformable distal arms extend symmetrically from the distal end of the non-deformable proximal arm towards the distal end.

[0116] Preferably, the deformable distal arm has the following characteristics from proximal to distal end:

[0117] A bendable proximal segment extends integrally from the distal end of the non-deformable proximal arm;

[0118] A bendable middle section extends integrally from the distal end of the bendable near section;

[0119] A bendable distal section extends integrally from the distal end of the bendable middle section;

[0120] The angle θ formed by the bendable near section and the bendable far section is between 60° and 200°, preferably between 90° and 190°.

[0121] Preferably, the widths of the bendable proximal section, the bendable middle section, and the bendable distal section are consistent with the width of the non-deformable proximal arm.

[0122] Preferably,

[0123] The width of the bendable proximal section is the same as the width of the non-deformable proximal arm;

[0124] The width of the proximal end of the bendable middle section is the same as the width of the bendable proximal section, and the width of the bendable middle section gradually narrows from the proximal end to the distal end.

[0125] The width of the far end of the bendable section is the same as the width of the far end of the bendable middle section.

[0126] Preferably, the bendable distal section has a plurality of clamping arm fixing holes.

[0127] Preferably, the non-deformable proximal arm has:

[0128] A mounting base extends from the side wall of the non-deformable proximal arm.

[0129] Preferably, the non-deformable proximal arm has:

[0130] The mounting base extends from the inner sidewall of the non-deformable proximal arm.

[0131] Preferably, the mounting base has at least one mounting hole.

[0132] Preferably, the outer clip further includes a retracting assembly, the retracting assembly having:

[0133] Two pairs of clamping shafts are respectively clamped on the inner and outer side walls of the deformable distal arm;

[0134] A pair of parallel seat cover plates, each with a sliding hole at its far corner, the inner diameter of the sliding hole gradually increasing from the outside to the inside, the two ends of each pair of clamping shafts sliding inward in a manner that tends to slide inward, thereby clamping and retracting the outer clamp.

[0135] Preferably, the sliding hole is L-shaped and has the following characteristics:

[0136] A proximal end hole, wherein the proximal end of the proximal end hole is located on the inner side and the distal end of the proximal end hole is located on the outer side;

[0137] A distal hole, wherein the proximal end of the distal hole is connected to the distal end of the proximal hole, the proximal end of the distal hole is located on the outer side, and the distal end of the distal hole is located on the inner side.

[0138] Preferably,

[0139] The distance between the proximal holes gradually increases from the inside to the outside;

[0140] The distance between the distal holes gradually increases from the outside to the inside, such that the clamping shaft tends to slide inward, thereby clamping and retracting the outer clamp.

[0141] Preferably,

[0142] The included angle β formed by the two sides of the proximal hole is 3° to 10°;

[0143] The included angle α formed by the two sides of the distal hole is 1° to 5°.

[0144] Preferably,

[0145] The angle γ formed by the centerline of the proximal orifice and the axis of the mitral valve clamp is 15° to 25°.

[0146] The angle δ formed by the centerline of the distal orifice and the axis of the mitral valve clamp is 60° to 70°.

[0147] Preferably, both ends of the clamping shaft have anti-dislodgement caps.

[0148] Preferably, the proximal corners on both sides of the seat cover plate each have at least one fixing hole for mounting the seat cover plate to the outer clamp of the mitral valve clamp.

[0149] Preferably, the seat cover is trapezoidal in shape, with the proximal side of the seat cover being smaller than the distal side.

[0150] Preferably, the distal side of the seat cover is concave arc-shaped.

[0151] Preferably,

[0152] The seat cover plate has at least one fixing hole on each of its two proximal corners;

[0153] The side wall of the non-deformable proximal arm has a mounting base, and the mounting base has at least one mounting hole corresponding to the position of the fixing hole;

[0154] The mounting plate is installed on both sides of the mounting base by means of a mounting rod passing through the fixing hole and the mounting hole.

[0155] Preferably,

[0156] The deformable distal arm has, from proximal end to distal end, a bendable proximal section, a bendable middle section, and a bendable distal section.

[0157] The clamping shafts abut against the inner and outer walls of the bendable middle section, respectively. The clamping shafts provide a fulcrum to support the bending deformation of the deformable distal arm, so that the included angle θ formed by the bending of the deformable distal arm is between 60° and 200°.

[0158] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0159] 1) By directly fixing the fixing plates of the first and second clamping plates and the distal ends of the two outer clamping arms to the inner and outer sidewalls of the first and second substrates respectively, the present invention provides a fixed connection rather than a hinged connection, which allows the outer clamping arms to move with the movement of the first and second substrates, and will not deform significantly due to the elastic material.

[0160] 2) The proximal ends of the first and second base plates of this invention are hinged to the proximal end of the inner clamp, and at this time, the proximal ends of the first and second base plates that are hinged are also the meshing ends, which mesh on the meshing section of the distal section of the inner rod. Even if they are hinged, they need to follow the direction of the meshing section of the distal section of the inner rod to move. That is, the opening and closing of the first and second base plates are restricted by the meshing and will not move freely up and down. The meshing design restricts the degree of freedom of the first and second base plates, increases stability, and the opening and closing process of the entire clamp is completely autonomous and controllable, and is less likely to cause secondary injury to the patient.

[0161] 3) The proximal section of the outer clamping arm of the present invention is provided with a mounting base, and a retracting component for retracting the outer clamping arm is provided on the mounting base, thereby effectively realizing the retracting function of the clamp. Attached Figure Description

[0162] Figure 1 This is a schematic diagram of the delivery device for the mitral valve clamp of the present invention;

[0163] Figures 2A-2D This is a schematic diagram of the mitral valve clamp of the present invention;

[0164] Figures 3A-3B This is a schematic diagram of the side structure of the mitral valve clamp of the present invention after it has been opened;

[0165] Figures 4A-4B This is a schematic diagram of the inner clip 20 of the present invention;

[0166] Figures 5A-5B This is a schematic diagram of the structure of the inner rod 10 of the present invention;

[0167] Figures 6A-6B This is a schematic diagram of the structure of the first and second substrates 30a and 30b of the present invention;

[0168] Figure 7 This is a schematic diagram of the structure of the first and second clips 40a and 40b of the present invention;

[0169] Figures 8A-8B This is a schematic diagram of the structure of the outer clip 50 of the present invention;

[0170] Figures 9A-9B This is a schematic diagram of the structure of the gathering component of the present invention;

[0171] Figure 10 This is a schematic diagram of the structure of the petal outer frame 60 of the present invention;

[0172] Figures 11A-11B This is a schematic diagram of the structure of the mitral valve clamp capturing the native leaflet 80 of the present invention. Detailed Implementation

[0173] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0174] During cardiac arrest, the left atrium receives oxygenated blood from the lungs. During diastole, blood previously collected in the left atrium moves through the mitral valve and into the left ventricle during systole, via the expansion of the left ventricle. During systole, the left ventricle contracts to force blood through the aortic valve and ascending aorta into the body. During systole, the leaflets of the mitral valve close to prevent blood from flowing back from the left ventricle into the left atrium, and blood is collected in the left atrium from the pulmonary veins. In one exemplary embodiment, the mitral valve clamp of the present invention is used to restore the function of a defective mitral valve. That is, the mitral valve clamp is configured to facilitate the closure of the mitral valve leaflets to prevent blood from flowing back from the left ventricle into the left atrium.

[0175] In the field of interventional medical devices, when describing the mitral valve clamp of the present invention, "proximal" or "proximal segment" refers to the side of the mitral valve clamp of the present invention located in the direction of the delivery device or the end operated by the user when the mitral valve clamp of the present invention is in the closed state. Correspondingly, "distal" or "distal segment" refers to the side of the mitral valve clamp of the present invention located away from the delivery device or the end operated by the user when the mitral valve clamp of the present invention is in the closed state.

[0176] In this invention, the spatial term "outer side" refers to the reference direction of the internal central axis of the mitral valve clamp of this invention, with the axis of the clamp in its fully closed state as the reference direction. The direction away from this central axis is the outer side, and the direction closer to the central axis is the inner side. The same applies to "outer side wall" and "inner side wall".

[0177] In this invention, when one or more elements or components are described as being connected, joined, fixed, axially connected, hinged, coupled, attached, or otherwise interconnected, such interconnection may be direct between components or may be indirect, such as by using one or more intermediary components. Furthermore, as described herein, references to “assembly,” “part,” “component,” or “section” should not be limited to a single structural component, member, or element, but may include assemblies of components, parts, or elements. Moreover, as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0178] In this invention, the term "hinge structure" refers to a structure that connects two components by means of a hinge. In specific applications, the hinge structure can be a shaft hole structure that fits a rotating shaft, a rotating shaft that fits a shaft hole, or a pivot structure. The hinge structure can be formed by folding or rolling sheets.

[0179] In this invention, the terms "integral", "integral connection" and "integral molding" refer to a structure formed in one step through processing techniques such as stamping, cutting, casting, and casting. The structure is a single, indivisible component.

[0180] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0181] In this invention, "axial direction" and "axis line" refer to the axisymmetric line in the clamped state. Of course, sometimes it also refers to the axisymmetric line of a certain axisymmetric component or element itself. The specific interpretation can be made appropriately based on the description and the accompanying drawings.

[0182] The mitral valve clamp of the present invention is implanted via a delivery catheter / delivery sheath of a delivery device. The delivery device extends the mitral valve clamp from the delivery catheter / delivery sheath into the left ventricle, and controls the opening of the mitral valve clamp via a control cable. Figures 11A-11B As shown, by controlling the first and second clips to open and capture the native leaflet, the mitral valve clamp is then closed by the outer clip, the first and second base plates together, capturing the native leaflet. After capturing the native leaflet, the mitral valve clamp is completely closed to clamp it onto the natural mitral valve. The traction wire is then pulled out from the traction hole of the clip assembly, and then the drive shaft of the delivery device is operated to disengage it from the mitral valve clamp. That is, the mitral valve clamp is separated from the distal end of the delivery catheter / delivery sheath by operating the delivery device, thus holding the mitral valve clamp on the natural valve, thereby completing the partial clamping of the natural valve. It should be noted that this mitral valve clamp needs to capture the native leaflet in the left ventricle. The mitral valve clamp can be delivered to the left ventricle via a transfemoral route or a transapical route. This mitral valve clamp can also be used for clamping the tricuspid valve, etc.

[0183] Reference Figure 1Taking a strand conveyor as an example, the following is a schematic diagram of the conveying device in one embodiment of the present invention, as shown below. Figure 1 As shown, in this embodiment, the delivery device 9, from proximal to distal end, sequentially includes a release mechanism 91, a delivery mechanism 92, an adjustable bend mechanism 93, a loader mechanism 94, and an outer sheath mechanism 95. The delivery mechanism 92 is detachably connected to the mitral valve clamp and is used to deliver the mitral valve clamp to the target position. The delivery mechanism 92 includes a delivery tube 920 and a delivery handle 921. The delivery tube 920 passes through and extends out of the adjustable bend 930. The delivery handle 921 includes a delivery housing and a pull-wire control assembly 922. The distal end of the delivery housing is connected to the proximal end of the delivery tube 920, and a delivery seal is detachably provided at the distal end of the delivery housing. The pull-wire control assembly 922 can slide axially along the delivery tube on the delivery housing. The pull-wire control assembly 922 connects the first and second clamping plates and the first and second base plates of the mitral valve clamp. When the pull-wire control assembly 922 slides axially, it controls the opening and closing of the first and second clamping plates and the opening of the first and second base plates. The number of knobs on the pull-wire control assembly 922 is at least equal to the sum of the number of the first and second clamping plates and the number of the first and second base plates, so that one knob controls the opening and closing of one first and second base plate clamping plate and the opening of one first and second base plate. In this embodiment, the delivery device 9 works in conjunction with the mitral valve clamp. During use, the delivery pull wire of the delivery structure 92 is detachably connected to the movable plates in the first and second clamping plates of the mitral valve clamp and passes through the second operating hole at the distal end of the first and second base plates. The second operating hole provides support for the pull wire. The remaining delivery pull wire of the delivery structure 92 passes through the operating hole at the distal end of the first and second base plates, thereby opening the two outer clamping arms and detachably connecting the drive shaft 90 of the release structure 91 (i.e., the inner rod of the present invention) to the mitral valve clamp. In some embodiments, the mitral valve clamp may also be referred to as a valve repair clamp.

[0184] like Figures 2A-2D As shown in 3A to 3B, one example of the mitral valve clamp of the present invention is an inner rod 10, an inner clamp 20, first and second substrates 30a and 30b, first and second clamping pieces 40a and 40b, and an outer clamp 50.

[0185] In another example of the mitral valve clamp of the present invention, there is an inner rod 10, an inner clamp 20, first and second substrates 30a and 30b, first and second clamping pieces 40a and 40b, an outer clamp 50, a petal frame 60, and a covering (not shown).

[0186] like Figures 4A-4BAs shown, in this example, the inner clamp 20 is a long U-shaped clamp. The distal end of the inner clamp 20 is the inner clamp seat end 21, which is the closed bottom of the long U-shaped clamp. The inner clamp seat end 21 is also U-shaped, but shorter in length. The inner clamp seat end 21 has an axial rod hole 211, and the distal end of the inner rod 10 passes through the rod hole 211 of the inner clamp seat end 21. In another example, the distal end of the inner clamp seat end 21 is integrally connected to a block end 212, and the rod hole 211 extends through the block end 212, so the inner rod 10 also passes through the rod hole 211 of the block end 212. The two sides of the inner clamp seat end 21 extend symmetrically towards the proximal end, forming the bodies of a long, flat, flat first inner clamp arm 22a and a second inner clamp arm 22b. The first and second inner clamp arms 22a and 22b are symmetrically arranged along the axis and their distal ends are integrally connected through the inner clamp base 21. The thickness of the first inner clamping arm 22a and the second inner clamping arm 22b is less than the thickness of the inner clamping seat end 21; the width of the first inner clamping arm 22a and the second inner clamping arm 22b is equal to the width of the inner clamping seat end 21. The distal ends of the first inner clamping arm 22a and the second inner clamping arm 22b are provided with second operating holes 221 through which the second pull wire 923 (conveyor pull wire) of the conveying structure 92 passes, providing a fulcrum for the second pull wire 923. In a preferred example, under natural conditions without external force, the distance between the proximal ends of the first inner clamping arm 22a and the second inner clamping arm 22b is less than the distance between their distal ends. At this point, the extension of the first inner clamping arm 22a and the second inner clamping arm 22b ends. However, the two side corners of the first inner clamping arm 22a continue to extend proximally and outwards integrally to form two first hinge ends 23a; the two side corners of the second inner clamping arm 22b continue to extend proximally and outwards integrally to form two second hinge ends 23b. The first hinge end 23a and the second hinge end 23b are the proximal ends of the first inner clamping arm 22a and the second inner clamping arm 22b, respectively, and are cylindrical in shape. The first and second hinge ends 23a and 23b are integrally formed with the proximal ends of the bodies of the first and second inner clamping arms 22a and 22b on the side surfaces of the cylinders. The axis of the first and second hinge ends 23a and 23b (here, the axis refers to the axis of the cylindrical hinge end) has hinge holes 231a and 231b, respectively. The proximal ends of the first and second substrates 30a and 30b are engagement ends, and the axis of the engagement end also has a hinge hole. The first hinge shaft 24a passes through the hinge holes of the two first hinge ends 23a and the hinge hole of the engagement end of the first substrate 30a. The engagement end of the first substrate 30a is located in the middle of the two first hinge ends 23a, and the proximal ends of the first substrate 30a and the first inner clamping arm 22a are hinged together. Similarly, the second hinge shaft 24b passes through the hinge holes of the two second hinge ends 23b and the hinge hole of the engagement end of the second substrate 30b. The engagement end of the first substrate 30b is located in the middle of the two second hinge ends 23b, and the proximal end of the second substrate 30b and the proximal end of the second inner clamping arm 22b are hinged together.The two ends of the first hinge shaft 24a are respectively movably inserted through one end of the two limiting members, and the two ends of the second hinge shaft 24b are respectively movably inserted through the other end of the two limiting members. The limiting members prevent the first and second inner clamping arms 22a and 22b from opening to both sides and deforming, thereby limiting the lateral displacement of the proximal ends of the first and second substrates during the opening / closing process, thus increasing the stability of the opening and closing process of the first and second substrates 30a and 30b. In one example, the limiting member 25 is a limiting plate 25 with an oblong hole. One end of the two limiting plates 25 is provided with a circular hole, and the two ends of the first hinge shaft 24a are respectively movably inserted through the circular hole of the two limiting plates 25; the other end of the two limiting plates 25 is provided with an oblong hole, and the two ends of the second hinge shaft 24b are respectively movably inserted through the oblong hole of the two limiting plates 25. In another example, one end of each of the two limiting plates 25 has an oblong hole, and the two ends of the first hinge shaft 24a are respectively movably inserted into the oblong holes of the two limiting plates 25; the other end of each of the two limiting plates 25 has a circular hole, and the two ends of the second hinge shaft 24b are respectively movably inserted into the circular holes of the two limiting plates. The oblong holes allow the ends of the first and second hinge shafts 24a and 24b passing through the proximal ends of the inner clamp to slide along the oblong holes, allowing for minor deformation of the proximal end of the inner clamp 20. This prevents the proximal end of the inner clamp 20 from losing flexibility and causing misalignment and jamming of the gears and racks at the proximal ends of the first and second base plates 30a and 30b, effectively reducing the machining accuracy of the clamp. The limiting element is not limited to the limiting plate 25 with the oblong hole; it can also be a flexible connecting rod connecting the proximal ends of the first inner clamp arm 22a and the second inner clamp arm 22b, such as a curved rod, a spring, or even a flexible wire.

[0187] like Figures 5A-5BAs shown, in this example, the inner rod 10 is a long, circular rod, which serves as the drive shaft 90 of the release structure 91 of the conveying device 9, used to convey the entire clamp. The proximal end of the inner rod 10 protrudes beyond the proximal end of the conveying device 9 for ease of operation, and the distal end of the inner rod 10 passes through the rod hole 211 of the inner clamp seat end 21 at the distal end of the inner clamp 20. A coaxial square post 11 is integrally formed on the outer surface of the distal section of the inner rod 10. The side length of the cross-section of the square post 11 is greater than the diameter of the inner rod 10, so that, in cross-section, the square post 11 protrudes beyond the outer surface of the inner rod 10. A meshing section is also provided at the distal section of the square post 11. This meshing section can reciprocally engage with the gears at the proximal meshing ends of the first and second substrates 30a and 30b. Specifically, the meshing section of the square pillar 11 has a first rack 12a and a second rack 12b. The teeth and grooves of the first and second racks 12a and 12b are perpendicular to the axial direction of the inner rod 10 and are arranged parallel to each other along the length direction of the surface of the square pillar 11, that is, the spacing between two adjacent teeth or grooves is the same. At the same time, the first rack 12a and the second rack 12b face away from each other, so that they can perfectly mesh with the gears at the meshing ends of the symmetrically arranged first and second substrates 30a and 30b near their proximal ends. In a preferred example, the first and second racks 12a and 12b are located at the distal end of the square pillar 11 and the distal ends of the first and second racks 12a and 12b are close to the distal end of the square pillar 11. The height of the teeth of the first and second racks 12a and 12b is flush with the proximal surface of the square pillar 11, and the bottom of the grooves of the first and second racks 12a and 12b is flush with the surface of the inner rod 10. This design, with the toothless distal end of the meshing section, allows for quick adjustment when the first and second substrates are opened and adjusted again, or when the first and second substrates are slightly opened and closed. The non-meshing portion and surface height of the proximal end of the square pillar 11 are flush with the tooth height of its first and second racks 12a and 12b. This is because when the first and second substrates 30a and 30b are opened, the gears move relative to each other along the proximal ends of the racks 12a and 12b. When the gears rotate to the proximal ends of the toothless gaps in the racks 12a and 12b, they cannot move further downwards, thus limiting the opening angle of the first and second substrates 30a and 30b. Generally, the relative opening angle of the first and second substrates 30a and 30b does not exceed 160°. Furthermore, the inner rod 10 surface outside the distal end of the first and second racks 12a and 12b is toothless, ensuring that the first and second substrates 30a and 30b, after clamping the leaflets, can... Figure 10As shown, the clamping force will not be affected by the interference of the first and second racks 12a and 12b, because when the first and second substrates 30a and 30b are closed, the gears will rotate relative to each other beyond the far ends of the first and second racks 12a and 12b, which also facilitates the smooth removal of the inner rod. In a preferred example, the modules of the first and second racks 12a and 12b are the same as the modules of the gears at the meshing ends of the first and second substrates 30a and 30b, respectively, and the tooth height of the first and second racks 12a and 12b is less than the tooth height of the gears at the meshing ends, or in other words, the meshing section uses a negative displacement rack. This design improves the tolerance during the meshing process of the meshing end and the meshing segment. When the distance between the center of the meshing end and the pitch line of the meshing segment is constant, even if there is a slight deviation between the meshing end and the meshing segment, the meshing end can still engage with the first and second racks 12a and 12b of the meshing segment. A second reason for this design is to facilitate the removal of the inner rod 10. Because the meshing segment is located on the square post 11, when the inner rod 10 is removed, the square post 11 must pass through the threaded hole near the end of the outer clamp 50. The maximum distance between any two points on the outline of the cross-section of the meshing segment is less than the inner diameter of the threaded hole, allowing it to pass smoothly through the threaded hole. The meshing segment uses a negative displacement design, effectively reducing the difficulty for the square post to pass through the threaded hole. The near section of the inner rod 10 (here, "near section" refers to the section closer to the far section compared to the meshing segment, but from the perspective of the entire inner rod 10, it is still considered the far section) has a feed external thread 13. The proximal end of the outer clamp 50 has a conveying internal thread, which is connected to the conveying internal thread through the conveying external thread 13. The proximal section of the inner rod 10 (the same applies here) passes through the proximal end of the outer clamp 50.

[0188] like Figures 6A-6BAs shown, in this example, the first substrate 30a and the second substrate 30b serve as bases for fixing the fixing plates of the first and second clamping pieces 40a and 40b, as well as the outer clamping arm of the outer clamp 50. The first and second substrates 30a and 30b, from proximal to distal, sequentially have an engaging end 31, a connecting section 32, and a flat plate section 33. The two ends of the connecting section 33 are integrally connected to the engaging end 31 and the flat plate section 33, respectively. The width of the engaging end 31 is smaller than the width of the flat plate section 33; the width of the proximal end of the connecting section 32 is the same as the width of the engaging end 31, and the width of the distal end of the connecting section 32 is the same as the width of the flat plate section 33. The width of the connecting section 32 itself increases continuously and smoothly from proximal to distal. The flat plate segments 33 of the first and second substrates 30a and 30b each have at least one substrate fixing hole 331, for example, two substrate fixing holes 331; the fixing plates of the first and second clamping pieces 40a and 40b each have at least one corresponding clamping piece fixing hole 421, for example, also two clamping piece fixing holes; the distal sections of the two outer clamping arms of the outer clamp 50 each have at least one corresponding clamping arm fixing hole 5224, for example, also two clamping arm fixing holes. The fixing plates of the first and second clamping pieces 40a and 40b, the distal sections of the first and second substrates 30a and 30b, and the distal sections of the two outer clamping arms of the outer clamp 50 are respectively fixedly connected together by a fixing rod sequentially passing through the corresponding clamping piece fixing holes 421, substrate fixing holes 331, and clamping arm fixing holes 5224. The distal ends of the flat plate segments 33 of the distal sections of the first and second substrates 30a and 30b also have a first operating hole 332 through which the first pull wire 924 (conveyor pull wire) of the conveying structure 92 passes. The first and second substrates 30a and 30b can be opened by pulling the first pull wire 924. The engagement end 31 of the first and second substrates 30a and 30b is cylindrical in shape. The axis of the cylindrical engagement end 31 has a through hinge hole. Therefore, the first and second hinge shafts 24a and 24b are inserted into the hinge holes of the two first and second hinge ends 23a and 23b and the hinge hole of the engagement end 31 of the first and second substrates 30a and 30b, respectively, with the engagement end 31 of the first and second substrates 30a and 30b located in the middle of the two first and second hinge ends 23a and 23b, respectively, and the proximal ends of the first and second substrates 30a and 30b are correspondingly hinged to the proximal ends of the first and second inner clamping arms 22a and 22b. The cylindrical meshing end 31 is perpendicular to the inner rod 10 in axial direction. The meshing end 31 is a gear, for example, a half gear with teeth and grooves on one half of its side surface. The half side surface has a plurality of teeth 311 and grooves spaced circumferentially along the meshing end 31. That is, the teeth and grooves of the meshing end 31 are also perpendicular to the axial direction of the inner rod 10. The spacing between two adjacent teeth 311 is equal, and the module is equal to that of the first and second racks 12a and 12b. With this configuration, the gears of the first and second base plates 30a and 30b can be reciprocally meshed with the first and second racks 12a and 12b of the inner rod 10.Therefore, when the distal ends of the first and second substrates 30a and 30b are opened by the first pull wire 924, even though the engaging ends 31 of the first and second substrates 30a and 30b and the first and second hinged ends 23a and 23b near the first and second inner clamping arms 22a and 22b are hinged, the movement of the engaging ends 31 of the first and second substrates 30a and 30b is restricted by the engaging section of the inner rod 10. Instead, the movement is controlled and rolls along the first and second racks on the engaging section of the inner rod 10, unlike a simple hinged structure which would move arbitrarily due to many uncontrollable factors (such as hinged ends and elasticity of the outer clamping arms). Therefore, in the clamping device of this application, the movement of the first and second substrates 30a and 30b is very easy to control during operation. Furthermore, the outer clamp arm of the outer clamp 50 is fixed to the outer side wall of the distal flat plate segment 33 of the first and second substrates 30a and 30b; the fixing pieces of the first and second clamping pieces 40a and 40b are fixed to the inner side wall of the distal flat plate segment 33 of the first and second substrates 30a and 30b. During the process of the first and second substrates 30a and 30b being pulled open in a controllable and stable manner by the first pull wire 924, the opening of the first and second clamping pieces 40a and 40b and the outer clamp arm of the outer clamp 50 is also a process of controllable and stable opening. The distal ends of the first and second substrates 30a and 30b have U-shaped bends 34, which wrap around the distal ends of the outer clamp arms, increasing the stability of the clamp. The outer clamp arm of the outer clamp 50 is not easily detached from the first and second substrates, and it also prevents the distal ends of the outer clamp arms from moving freely and scratching tissues such as heart valve leaflets. The distal ends of the first and second substrates 30a and 30b have protrusions 35 facing inward, which provide a bending passage for the original leaflets after the clamping process.

[0189] like Figure 7As shown, in this example, the first and second clips 40a and 40b are large elongated pieces with a double-layer structure. A small piece is cut out from the middle of the large elongated piece, leaving a hollow long frame. This long frame is the movable piece 41, and the cut-out small piece is the fixed piece 42. Therefore, the long frame and the small piece also have a double-layer structure. The proximal end of the cut-out portion of the long frame is connected to the proximal end of the small piece, that is, the proximal ends of the movable piece 41 and the fixed piece 42 are connected as a whole. The fixed piece 42 has clip fixing holes 421. The fixing rods are sequentially passed through the corresponding clip fixing holes 421, substrate fixing holes 331, and clamping arm fixing holes 5224 of the fixed piece 42, thereby fixing the fixed pieces 42 of the first and second clips 40a and 40b, the distal sections of the first and second substrates 30a and 30b, and the distal sections of the two outer clamping arms together. The outer walls of the fixing plates 42 of the first and second clamping plates 40a and 40b are respectively attached and fixed to the inner walls of the first and second substrates 30a and 30b. The movable plate 41, i.e., the long frame facing the first and second substrates 30a and 30b, has several barbs 43 cut in the same direction at its edge. The distal end of the movable plate 41 has a clamping plate operation hole 411 through which the second pull wire 923 (conveyor pull wire) of the conveying structure 92 passes. During operation, the distal ends of the first and second inner clamping arms 22a and 22b can be pulled and connected to the distal ends of the movable plate 41 of the first and second clamping plates 40a and 40b respectively by the common passage of the second pull wire 923. When the second pull wire 923 is pulled, the second pull wire 923 can be supported by the second operation hole 221 of the first and second inner clamping arms 22a and 22b, and the movable plate 41 and the fixing plate 42 are pulled open. When approaching the original leaflet, as... Figures 11A-11B As shown, the first and second clips 40a and 40b, which are opened, can capture the native leaflets.

[0190] like Figures 8A-8BAs shown, in this example, the outer clamp 50 has an outer clamp seat end 51 located at the proximal end; the outer clamp seat end 51 has a threaded hole with a delivery internal thread 511 inside, which is connected to the delivery internal thread 511 through the delivery external thread 13 of the proximal section of the inner rod 10. The proximal section of the inner rod 10 (this proximal section is relative to the engagement section; here, from the perspective of the entire inner rod 10, it is still the distal section) passes through the proximal end of the outer clamp 50. Two outer clamp arms 52 extend symmetrically from both sides of the outer clamp seat end 51 toward the distal end integrally. That is, the two outer clamp arms 52 are symmetrically arranged along the axis and their proximal ends are integrally connected through the outer clamp seat end 51. Specifically, the outer clamp arms 52 have a non-deformable proximal arm 521 and a deformable distal arm 522. The non-deformable proximal arm 521 extends integrally from one side of the outer clamp seat end 51 toward the distal end; the deformable distal arm 522 continues to extend integrally from the distal end of the non-deformable proximal arm 521 toward the distal end. The deformable distal arm 522 has a bendable proximal section 5221, a bendable middle section 5222, and a bendable distal section 5223 sequentially from its proximal end to its distal end. The bendable proximal section 5221 extends integrally from the distal end of the non-deformable proximal arm 521; the bendable middle section 5222 extends integrally from the distal end of the bendable proximal section 5221; and the bendable distal section 5223 extends integrally from the distal end of the bendable middle section 5222. The bendable distal section 5223 of the outer clamping arm 52 has a clamping arm fixing hole 5224. By sequentially passing through the corresponding clamping plate fixing holes 421, substrate fixing holes 331, and clamping arm fixing holes 5224 with fixing rods, the fixing plates of the first and second clamping plates 40a and 40b, the distal sections of the first and second substrates 30a and 30b, and the distal sections of the two outer clamping arms 52 are respectively fixedly connected together. That is, the inner wall of the bendable distal section 5223 of the outer clamping arm 52 is attached and fixed to the distal outer wall of the first and second substrates 30a and 30b. Thus, the outer clamping arm 52 provides elasticity to the first and second substrates 30a and 30b. Under the pull of the first pull line 924 of the conveying structure 92, the distal ends of the first and second substrates 30a and 30b are opened, and the engaging ends 31 of the first and second substrates 30a and 30b move steadily and controllably towards the proximal end along the engaging section of the inner rod 10. The bendable distal section 5223 of the outer clamping arm 52 is also opened steadily and controllably because it is fixedly connected to the outer wall of the first and second substrates 30a and 30b. At this time, the bendable proximal section 5221 and the bendable distal section 5223 of the outer clamping arm 52 are bent with the bendable middle section 5222 as the transition to form an included angle θ, which is approximately 90° to 150°. Of course, due to the elasticity of the material of the outer clamping arm 52, the included angle θ can be further increased, for example, θ can be 60°. When the tension of the first pull wire 924 is removed, the bendable near-bendable section 5221 and the bendable far-bendable section 5223 of the outer clamping arm 52 return to the natural state of the material itself, i.e., almost straight, that is, the angle θ is approximately 180°. Furthermore, under the retraction of the retraction component 53, assuming that there are no other components inside the outer frame 50 at this time, only... Figure 9AAs shown, only the retracting assembly 53 and the outer frame 50 are present. Under the action of the retracting assembly 53, the bendable proximal section 5221 and bendable distal section 5223 of the outer clamping arm 52 can be further bent inward, forming an angle θ of approximately 190° or even 200°. Therefore, the outer frame 50 can provide greater clamping force for the first and second substrates 30a, 30b and the first and second clamping plates 40a, 40b, promoting more stable clamping of the original leaflet by the mitral valve clamp. In one example, the widths of the bendable proximal section 5221, the bendable middle section 5222, and the bendable distal section 5223 are consistent with the width of the non-deformable proximal arm 521. In another example, the width of the bendable proximal segment 5221 is the same as the width of the non-deformable proximal arm 521; the width of the proximal end of the bendable middle segment 5222 is the same as the width of the bendable proximal segment 5221, and the width of the bendable middle segment 5222 gradually narrows from the proximal end to the distal end; the width of the bendable distal segment 5223 is the same as the width of the distal end of the bendable middle segment 5222, and the width of the bendable distal segment 5223 is one-third to two-thirds of the width of the bendable proximal segment 5221.

[0191] In this example, the outer clamping arm 52 has a mounting base 523 extending from the side wall of the non-deformable proximal arm 521. A preferred example is that the mounting base 523 extends from the inner side wall of the non-deformable proximal arm 521. The mounting base 523 has at least one mounting hole 5231. For example, two mounting holes at different locations, for different native leaflets, are provided on the base, with mounting holes 5231b closer to the distal end of the middle of the outer clamp 50 than mounting holes 5231a. Correspondingly, mounting holes 5311a and 5311b are provided at corresponding positions on the corresponding seat cover plate. With this design, for example, if the patient has a thicker native leaflet, the petal frame 60 can be adjusted and installed into mounting hole 5231a, while if the patient's native leaflet is thinner, the position of the petal frame 60 can be adjusted and installed into mounting hole 5231b, allowing the petal frame 60 to better assist the first and second substrates in clamping the leaflet.

[0192] like Figures 9A-9B As shown, in this example, the outer clamp 50 also has a retracting assembly 53. The retracting assembly 53 has a pair of parallel seat cover plates 531 and two pairs of clamping shafts 532. The two pairs of clamping shafts 532 are respectively clamped on the inner and outer walls of the bendable middle section 5222 of the deformable distal arm 522 of the two outer clamping arms 52. The clamping shafts 532 abut against the inner and outer walls of the bendable middle section 5222, providing a fulcrum to support the bending deformation of the deformable distal arm 522, so that the bending angle θ of the deformable distal arm 522 in its natural state reaches 200° or even larger. Each end of the clamping shaft 532 has an anti-disengagement cap, which is a ring or plate with a diameter larger than the sliding hole, fixed to both ends of the clamping shaft 532, so that the clamping shaft 532 cannot slide out of the sliding hole.

[0193] In this example, the seat cover 531 is trapezoidal in shape to accommodate the state of the mitral valve clamp after clamping the original leaflet. The proximal side of the seat cover 531 is smaller than the distal side, and the distal side of the seat cover 531 is concave arc-shaped to avoid the limiting plate 25. The seat cover 531 is respectively installed on both sides of the non-deformable proximal arm 521 of the two outer clamping arms 52. The proximal corners on both sides of the seat cover 531 each have at least one fixing hole 5311, which corresponds to the position of the mounting hole 5231 of the mounting seat 523. The seat cover 531 is installed on both sides of the mounting seat 523 by passing the mounting rod through the fixing hole 5311 and the mounting hole 5231 of the mounting seat 523 of the non-deformable proximal arm 521. Each of the distal corners of the cover plate 531 has a sliding hole, the inner diameter of which gradually increases from the outer to the inner side. Both ends of each pair of clamping shafts 532 are slidably positioned within the sliding hole in a manner that tends to slide inwards, thereby clamping and retracting the outer clamp. Simultaneously, clamping shafts 532 are provided on both sides of the outer clamp, and these shafts correspond to areas of greater deformation of the outer clamp, preventing twisting during the outward flipping process. Specifically, the sliding hole is L-shaped, with a proximal hole 5312 and a distal hole 5313. The proximal end of the proximal hole 5312 is on the inner side, and the distal end is on the outer side. The proximal end of the distal hole 5313 is connected to the distal end of the proximal hole 5312, with the proximal end of the distal hole 5313 on the outer side and the distal end on the inner side. The distance between the proximal holes 5312 from the inside to the outside (equal to the diameter of the clamping shaft that can be accommodated between the sliding holes) gradually increases; the distance between the distal holes 5313 from the outside to the inside gradually increases, and the distance between the inner sides of the distal holes 5313 is equal to the diameter of the clamping shaft 532; so that the clamping shaft 532 tends to slide inward under the action of the elastic force of the sliding holes, thereby clamping the outer clamp. Under the limitation of the anti-dislodgement cap (not shown) of the clamping shaft 532, the clamping shaft 532 will not slip out of the sliding holes. Because the hole spacing gradually increases from the proximal end to the distal end, the included angle β formed by the two sides of the proximal hole 5312 is 3° to 10°. This setting makes the hole spacing of the proximal hole 5312 change greatly and the hole spacing decreases sharply, making it impossible for the clamping shaft 532 to fall into the proximal hole 5312 of the L-shaped sliding hole. However, the narrow side of the outer side of the proximal hole 5312 is retained. The narrow side is relatively elastic and can form an L-shaped narrow side with the narrow side of the outer side of the distal hole 5312. The elastic force of the deformation is used to provide force for the clamping shaft 532. The included angle α formed by the two sides of the distal hole 5313 is 1° to 5°, forming a sliding hole with a gradually decreasing hole spacing, which is conducive to the sliding of the clamping shaft 532 in the sliding hole.The angle γ formed by the centerline of the proximal orifice 5312 and the axis of the mitral valve clamp is 15° to 25°; the angle δ formed by the centerline of the distal orifice 5313 and the axis of the mitral valve clamp is 60° to 70°. By controlling the angles γ and δ, the shape and angle setting of the L-shaped sliding orifice are controlled. According to the actual maximum bending point and maximum deformation trajectory during the opening and closing of the external clamp of different sizes of mitral valve clamps, the specific values ​​of the angles γ and δ can be flexibly adjusted to make the sliding orifice more adaptable to the opening and closing of the external clamp. The specific values ​​can be obtained by those skilled in the art through simple experiments. As the hole spacing of the distal hole 5313 gradually increases inward, after the tension of the first pull line is removed, the deformable distal arm 522 springs back, and the clamping shaft 532 on its outer side loses the outward pushing pressure of the deformable distal arm 522. Therefore, under the elastic force of the sliding hole, the clamping shaft 532 moves in the direction of the larger hole spacing, that is, moves inward to the distal end. The clamping shaft 532 located on the outer side of the deformable distal arm 522 further pushes the deformable distal arm 522 inward, thereby completing the folding of the outer clamping arm 52 of the entire outer clamp 50.

[0194] like Figure 10 As shown, in this example, the two petal frames 60 are located on the outer sides of the outer clamping arm. Each petal frame 60 has a short rod 61 located at the distal end; two long rods 62 extending from the sides of the short rod 61 towards the proximal end; and two mounting rods 63, linearly symmetrical with a certain distance between them, vertically connected to the proximal ends of the long rods 62. The long rods 62 are slightly curved, resembling lotus petals. The two mounting rods 63 are sequentially inserted into the fixing holes 5311 on the cover plate 531 and the mounting holes 5231 of the mounting base 523 of the non-deformable proximal arm 521. The mounting rods 63 of the petal frame 60, inserted into the mounting holes 5231, can rotate relative to each other without requiring the petal frame 60 to provide elasticity; instead, they assist the first and second substrates in further clamping the original petals. Of course, the mounting rods 63 of the petal frame 60 can also be fixed within the mounting holes 5231 to achieve the purpose of this invention. The coating (not shown) covers the petal frame 60 and the corresponding outer clamping arm 52 together, including the first and second substrates 30a and 30b, as well as the fixing pieces of the first and second clamping pieces 40a and 40b fixed to the first and second substrates 30a and 30b. The coated clamp can reduce secondary damage to the heart and promote the endothelialization of the mitral valve clamp and the heart valve leaflets.

[0195] The specific embodiments described herein are merely illustrative of the spirit of the invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to substitute them, without departing from the spirit of the invention or exceeding the scope defined by the appended claims.

Claims

1. An external clamp for a mitral valve clamp, characterized in that... have: One external clamping end, located at the proximal end; Two non-deformable proximal arms extend symmetrically from both sides of the outer clamp end toward the distal end in one piece; Two deformable distal arms extend symmetrically from the distal end of the non-deformable proximal arm toward the distal end in an integral manner; A gathering component, the gathering component having: Two pairs of clamping shafts are respectively clamped on the inner and outer side walls of the deformable distal arm; A pair of parallel seat cover plates, each with a sliding hole at the far corner of each side of the seat cover plate, the inner diameter of the sliding hole gradually increasing from the outer side to the inner side, and the two ends of each pair of clamping shafts sliding inward in a manner that tends to slide inward, thereby clamping and retracting the outer clamp. The sliding hole is L-shaped and has the following characteristics: A proximal end hole, wherein the proximal end of the proximal end hole is located on the inner side and the distal end of the proximal end hole is located on the outer side; A distal hole, wherein the proximal end of the distal hole is connected to the distal end of the proximal hole, the proximal end of the distal hole is located on the outer side, and the distal end of the distal hole is located on the inner side.

2. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The deformable distal arm has the following features from proximal to distal end: A bendable proximal segment extends integrally from the distal end of the non-deformable proximal arm; A bendable middle section extends integrally from the distal end of the bendable near section; A bendable distal section extends integrally from the distal end of the bendable middle section; The angle θ formed by the bendable near segment and the bendable far segment is between 60° and 200°.

3. The external clamp for the mitral valve clamp as described in claim 2, characterized in that... The angle θ formed by the bendable near segment and the bendable far segment is between 90° and 190°.

4. The external clamp for the mitral valve clamp as described in claim 2 or 3, characterized in that... The widths of the bendable proximal section, the bendable middle section, and the bendable distal section are consistent with the width of the non-deformable proximal arm.

5. The external clamp for the mitral valve clamp as described in claim 2 or 3, characterized in that... The width of the bendable proximal section is the same as the width of the non-deformable proximal arm; The width of the proximal end of the bendable middle section is the same as the width of the bendable proximal section, and the width of the bendable middle section gradually narrows from the proximal end to the distal end. The width of the far end of the bendable section is the same as the width of the far end of the bendable middle section.

6. The external clamp for the mitral valve clamp as described in claim 2, characterized in that... The bendable distal section has several clamping arm fixing holes.

7. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The non-deformable proximal arm has: A mounting base extends from the side wall of the non-deformable proximal arm.

8. The external clamp for the mitral valve clamp as described in claim 7, characterized in that... The non-deformable proximal arm has: The mounting base extends from the inner sidewall of the non-deformable proximal arm.

9. The external clamp for the mitral valve clamp as described in claim 8, characterized in that... The mounting base has at least one mounting hole.

10. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The distance between the proximal holes gradually increases from the inside to the outside; The distance between the distal holes gradually increases from the outside to the inside, such that the clamping shaft tends to slide inward, thereby clamping and retracting the outer clamp.

11. The external clamp for the mitral valve clamp as described in claim 10, characterized in that... The included angle β formed by the two sides of the proximal hole is 3°~10°; The included angle α formed by the two sides of the distal hole is 1°~5°.

12. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The angle γ formed by the centerline of the proximal orifice and the axis of the mitral valve clamp is 15°~25°. The angle δ formed by the centerline of the distal orifice and the axis of the mitral valve clamp is 60°~70°.

13. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The clamping shaft has anti-detachment caps at both ends.

14. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The proximal corners on both sides of the seat cover plate each have at least one fixing hole for mounting the seat cover plate onto the outer clamp of the mitral valve clamp.

15. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The seat cover is trapezoidal in shape, with the proximal side being smaller than the distal side.

16. The external clamp for the mitral valve clamp as described in claim 1 or 15, characterized in that... The far side of the seat cover is concave arc-shaped.

17. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The seat cover plate has at least one fixing hole on each of its two proximal corners; The side wall of the non-deformable proximal arm has a mounting base, and the mounting base has at least one mounting hole corresponding to the position of the fixing hole; The mounting plate is installed on both sides of the mounting base by means of a mounting rod passing through the fixing hole and the mounting hole.

18. The external clamp for the mitral valve clamp as described in claim 1, characterized in that... The deformable distal arm has, from proximal end to distal end, a bendable proximal section, a bendable middle section, and a bendable distal section. The clamping shafts abut against the inner and outer walls of the bendable middle section, respectively. The clamping shafts provide a fulcrum to support the bending deformation of the deformable distal arm, so that the included angle θ formed by the bending of the deformable distal arm is between 60° and 200°.

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