Connection assembly and valve clamping system

Abstract

The application provides a connecting assembly and a valve clamping system comprising the same. The connecting assembly comprises a first fixing member, a second fixing member, a mandrel, a locking member and an elastic member. The first fixing member is fixedly connected with a delivery sheath tube and is provided with a first axial inner cavity. The second fixing member is fixedly connected with a medical implant. The mandrel is movably arranged in the first axial inner cavity. The proximal end of the locking member is rotatably connected with the first fixing member and partially extends into the first axial inner cavity. The elastic member is arranged between the locking member and the first fixing member. The connecting assembly has a connected state and a released state. In the connected state, the mandrel abuts against the proximal end of the locking member, so that the distal end of the locking member is kept inserted into the second fixing member in the radial direction. In the released state, the mandrel has a radial gap with the proximal end of the locking member or is withdrawn from the first axial inner cavity, and the elastic member drives the corresponding locking member to rotate the proximal end of the locking member, so that the distal end of the locking member is radially separated from the second fixing member to release the connection.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a connection component for a medical implant and a valve clamping system including the connection component. Background Technology

[0002] The mitral and tricuspid valves, among others, are one-way valves in the heart. Normal, healthy atrioventricular valves control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles back to the atria. For example, the mitral valve, located between the left atrium and left ventricle, controls the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle back to the left atrium. The tricuspid valve, located between the right atrium and right ventricle, controls the flow of blood from the right atrium to the right ventricle, while preventing blood from flowing from the right ventricle back to the right atrium. The mitral valve consists of an anterior and posterior leaflets, while the tricuspid valve consists of an anterior leaflet, a posterior leaflet, and a septal leaflet. Under normal circumstances, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral or tricuspid valve completely align, preventing blood from flowing from the ventricle to the atrium. If the leaflets or related structures undergo organic or functional changes, such as partial rupture of the chordae tendineae, resulting in poor occlusion of adjacent leaflets of the mitral or tricuspid valve, the mitral or tricuspid valve cannot close completely when the left or right ventricle contracts, causing blood to flow back from the ventricle to the atrium, thus causing a series of pathophysiological changes, known as "mitral regurgitation" or "tricuspid regurgitation".

[0003] Edge-to-edge repair of the atrioventricular valves is an effective treatment for atrioventricular regurgitation. Specifically, it involves fixing the edges of the valve leaflets that cannot properly align together using sutures or clamping to reduce the leaflet gap and create a double-pore structure, thereby eliminating or reducing regurgitation. Traditional edge-to-edge repair of the atrioventricular valves is performed under direct visualization during surgery, usually requiring open-chest surgery and establishing extracorporeal circulation, which carries a high risk.

[0004] With the development of technology, minimally invasive interventional devices for treating mitral regurgitation have emerged. Based on the principle of edge-to-edge valve repair, these devices open the valve clamp to grasp the anterior and posterior leaflets, and then close the clamp to hold the leaflets. During the delivery, opening, and closing of the valve clamp, the delivery sheath should remain connected to the valve clamp. After the leaflets are clamped, the connection between the valve clamp and the delivery sheath should be released to release the valve clamp.

[0005] Figure 1This diagram illustrates a conventional connection structure between a valve clamp and a delivery sheath: a barb a at the distal end of the delivery sheath inserts from the inside out into a locking hole b located near the proximal end of the valve clamp to establish a connection; the connection is released when the barb a retracts inward. After the valve leaflets are clamped, the distal end of the delivery sheath and the valve clamp are usually not in the same direction (or on the same straight line), making the valve clamp highly susceptible to lateral forces. Therefore, when releasing the connection, the barb a is highly likely to get stuck in the locking hole b or clamp the inner wall of the proximal end of the valve clamp, making valve clamp release difficult and posing a risk of release failure. Summary of the Invention

[0006] The purpose of this application is to provide a connecting component and a valve clamping system including the connecting component. The connecting component can be used to connect the delivery sheath and valve clamp of the valve clamping system. The connecting component can easily and smoothly release medical implants such as valve clamps, eliminating the risk of release failure.

[0007] To achieve the above objectives, this application provides a connecting assembly for connecting a delivery sheath and a medical implant. The connecting assembly includes a first fixing member, a second fixing member, a mandrel, at least two locking members, and at least two elastic members. The proximal end of the first fixing member is fixedly connected to the distal end of the delivery sheath, and it has a first axial cavity. The distal end of the second fixing member is fixedly connected to the proximal end of the medical implant. The mandrel is movably inserted within the first axial cavity. The proximal end of each locking member is rotatably connected to the first fixing member and partially extends into the first axial cavity. One elastic member is correspondingly disposed between one locking member and the first fixing member. The connecting assembly has a connected state and a disengaged state; in the connected state, the mandrel abuts against the proximal end of each of the locking members, such that the distal end of each of the locking members remains radially inserted into the second fixing member; in the disengaged state, there is a radial gap between the mandrel and the proximal end of each of the locking members, or the mandrel is withdrawn from the first axial cavity, and each of the elastic members drives the corresponding locking member, such that the proximal end of each of the locking members rotates, and the distal end of each of the locking members moves radially away from the second fixing member.

[0008] On the other hand, this application also provides a valve clamping system, including a delivery sheath, a valve clamp, and the aforementioned connecting components. The proximal end of the first fixing member is fixedly connected to the distal end of the delivery sheath, and the distal end of the second fixing member is fixedly connected to the proximal end of the valve clamp. The second fixing member has a second axial cavity communicating with the first axial cavity, and the mandrel is movably disposed within the first axial cavity and the second axial cavity. The valve clamp includes a drive mechanism, and the distal end of the mandrel is detachably connected to the drive mechanism. When the mandrel moves axially within the first axial cavity and the second axial cavity, the mandrel drives the drive mechanism to open and close the valve clamp.

[0009] The connecting assembly and valve clamping system provided in this application include a first fixing member with a first axial inner cavity and a delivery sheath fixedly connected to its proximal end, a second fixing member with a medical implant fixedly connected to its distal end, a mandrel movably inserted into the first axial inner cavity, a locking member rotatably connected to the first fixing member at its proximal end and partially extending into the first axial inner cavity, and an elastic member correspondingly disposed between the locking member and the first fixing member. The overall structure of the connecting assembly is simple. By controlling the axial movement of the mandrel to abut the proximal end of the locking member, the distal end of the locking member is radially inserted into the second fixing member from the outside in, thus achieving the connection between the valve clamp and the delivery sheath, which is convenient to operate. Furthermore, when the mandrel is released from abutting the proximal end of the locking member, the elastic member applies an elastic driving force to the corresponding locking member, pushing the locking member to automatically open outward, so that the distal end of the locking member moves radially away from the second fixing member, thereby completely releasing the connection between the valve clamp and the delivery sheath. Even if the valve clamp is subjected to lateral force, it can still be easily and readily released, ensuring successful release. Attached Figure Description

[0010] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some implementation methods of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0011] Figure 1 This is a schematic diagram of the connection structure between a valve clamp and a delivery sheath in the prior art.

[0012] Figure 2 This is a three-dimensional structural schematic diagram of a valve clamping system provided in one embodiment of this application.

[0013] Figure 3 yes Figure 2 The side view of the valve clamping system shown.

[0014] Figure 4 yes Figure 2 The diagram shows a three-dimensional structure of the valve clamping system after the valve clamp is opened.

[0015] Figure 5 yes Figure 4 The axial cross-sectional view of the valve clamping system shown.

[0016] Figure 6 yes Figure 4 The diagram shows the structure of the connecting components in the connected state.

[0017] Figure 7 yes Figure 6 The axial sectional view of the connecting assembly shown.

[0018] Figure 8 yes Figure 7 A partial axial sectional view of the connecting assembly shown.

[0019] Figure 9 yes Figure 8 The diagram shows a partial axial sectional view of the connecting assembly in a disengaged state.

[0020] Figure 10 yes Figure 6 The diagram shows a three-dimensional structure of the first fixing member and the elastic member.

[0021] Figure 11 yes Figure 10 The side view of the first fixing member and the elastic member is shown.

[0022] Figure 12 yes Figure 11 The first fixing member and the elastic member shown are cross-sectional views along the XII-XII direction.

[0023] Figure 13 yes Figure 10 The front view of the first fixing member and the elastic member is shown.

[0024] Figure 14 yes Figure 13 The image shows a bottom view of the first fixing member and the elastic member.

[0025] Figure 15 yes Figure 6 A three-dimensional structural schematic diagram of the second fastener is shown.

[0026] Figure 16 yes Figure 15 The side view of the second fastener is shown.

[0027] Figure 17 yes Figure 16 The second fastener is shown in an axial sectional view.

[0028] Figure 18 yes Figure 6 The diagram shows the structure of the connecting assembly without the mandrel.

[0029] Figure 19 yes Figure 18 The connecting component shown is a cross-sectional view along the XIX-XIX direction.

[0030] Figure 20 yes Figure 18 The connecting component shown is a cross-sectional view along the XX-XX direction.

[0031] Figure 21 yes Figure 18 The top view of the connecting components shown.

[0032] Figure 22 yes Figure 6 A three-dimensional structural diagram of the locking component shown.

[0033] Figures 23 to 25 This is a schematic diagram illustrating the usage process of the valve clamping system provided in this application.

[0034] The following detailed description, in conjunction with the accompanying drawings, will further illustrate this application. Detailed Implementation

[0035] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0036] Furthermore, the following descriptions of the embodiments are with reference to the accompanying illustrations, which illustrate specific embodiments in which this application can be implemented. Directional terms used in this application, such as "up," "down," "front," "back," "left," "right," "inner," "outer," and "side," are merely for reference to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of this application, and are not intended to indicate or imply that the referred device or element must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting this application.

[0037] It should be noted that, in order to more clearly describe the structure of the connecting components and valve clamping system provided in this application, the limiting terms "proximal" and "distal" used in the specification are conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object such as a cylinder or tube (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction is along the diameter or radius. It is worth noting that the "end" appearing in terms such as "proximal," "distal," "one end," "the other end," "first end," "second end," "initial end," "terminal," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, end point, or end face, but also includes the portion extending axially and / or radially from the tip, end point, or end face on the element to which the tip, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The conventional terms used in this application's specification are for the purpose of describing particular embodiments only and should not be construed as limiting the scope of this application.

[0038] Please refer to the following: Figures 2 to 5 This application provides a valve clamping system 1 for edge-to-edge repair of atrioventricular valves (including but not limited to mitral and tricuspid valves) to treat regurgitation (including but not limited to mitral regurgitation and tricuspid regurgitation). Specifically, the valve clamping system 1 includes a delivery sheath 20, a valve clamp 40, and a connecting assembly 60 connecting the delivery sheath 20 and the valve clamp 40. The delivery sheath 20, after being connected to the valve clamp 40 via the connecting assembly 60, is used to deliver the valve clamp 40 to the vicinity of the atrioventricular valve. The valve clamp 40 is used to capture and clamp the atrioventricular valve, and after successful valve clamping, it is released and implanted into the patient. The connection assembly 60 is used to maintain the connection and lock between the delivery sheath 20 and the valve clamp 40 during the delivery process of the valve clamp 40 and during the process of the valve clamp 40 capturing and clamping the valve, and to release the valve clamp 40 after the valve clamp 40 successfully clamps the valve.

[0039] Please refer to the following: Figures 5 to 9 The connecting assembly 60 includes a first fixing member 61, a second fixing member 63, at least two locking members 65, a spindle 67, and at least two elastic members 69. For example... Figure 5As shown, the proximal end of the first fixation member 61 is fixedly connected to the distal end of the delivery sheath 20, and the first fixation member 61 has a first axial inner cavity 612 extending through its proximal and distal ends, which communicates with the lumen of the delivery sheath 20. The distal end of the second fixation member 63 is fixedly connected to the proximal end of the valve clamp 40. The mandrel 67 is movably inserted within the first axial inner cavity 612, and its proximal end extends out of the patient's body through the lumen of the delivery sheath 20. Figures 6 to 9 As shown, the proximal end of each locking member 65 is rotatably connected to the first fixing member 61 and partially extends into the first axial inner cavity 612. An elastic member 69 is correspondingly disposed between a locking member 65 and the first fixing member 61.

[0040] It should be noted that the connection component 60 provided in this application has a connected state and a disconnected state. Specifically, as shown in the figure... Figure 8 As shown, in the connected state, the spindle 67 abuts against the proximal end of each locking member 65, such that the distal end of each locking member 65 remains radially inserted into the second fixing member 63. Thus, the first fixing member 61 and the second fixing member 63 are connected and locked via the locking member 65, thereby also connecting and locking the delivery sheath 20 and the valve clamp 40 via the connecting assembly 60. Figure 9 As shown, in the disengaged state, there is a radial gap between the mandrel 67 and the proximal end of each locking member 65, or the mandrel 67 is withdrawn from the first axial inner cavity 612. Each elastic member 69 drives the corresponding locking member 65, causing the proximal end of each locking member 65 to rotate and the distal end of each locking member 65 to move radially away from the second fixing member 63. Thus, the first fixing member 61 and the second fixing member 63 are disconnected, thereby also disconnecting the delivery sheath 20 and the valve clamp 40. The valve clamp 40 that successfully clamps the valve and its proximal connection to the second fixing member 63 can then be detached from the delivery sheath 20 and released into the patient's body.

[0041] The operator can apply external force to each locking member 65 to rotate the proximal end of each locking member 65 and insert the distal end of each locking member 65 radially into the second fixing member 63, and then insert the mandrel 67 into the first axial inner cavity 612 to abut the proximal end of each locking member 65, so that the connecting assembly 60 is in the connected state.

[0042] It is easy to see that the connecting assembly 60 provided in this application has a simple overall structure. By controlling the axial movement of the spindle 67 to abut against the proximal end of the locking member 65 or to release the abutment against the locking member 65, the connection and locking between the valve clamp 40 and the delivery sheath 20, or the release of the valve clamp 40, can be achieved, making the operation convenient. Furthermore... The connecting assembly 60, through the distal end of the locking member 65, radially inserts into the second fixing member 63 from the outside in, thereby connecting the delivery sheath 20 and the valve clamp 40. When the mandrel 67 releases its pressure on the proximal end of the locking member 65, the elastic member 69 applies an elastic driving force to the corresponding locking member 65, thereby pushing the locking member 65 to automatically open outward, causing the distal end of the locking member 65 to radially move away from the second fixing member 63, thus completely releasing the connection between the valve clamp 40 and the delivery sheath 20. Because the elastic member 69 can radially push the locking member away from the second fixing member 63, the valve clamp 40 can still be easily and readily released even under lateral force, eliminating the risk of release failure. Furthermore, it is understood that when the valve clamp 40 is subjected to lateral force, the connection structure between the delivery sheath 20 and the valve clamp 40 will also be affected by this lateral force, but unlike... Figure 1 The delivery sheath and valve clamp are connected by an inside-out connection structure (i.e., the barb at the distal end of the delivery sheath is inserted into the locking hole at the proximal end of the valve clamp), while the connection assembly 60 is connected by an outside-in connection structure (i.e., the distal end of the locking member 65 is inserted into the second fixing member 63). In comparison, the outside-in connection structure is easier to disengage when subjected to lateral force than the inside-out connection structure, thus making it easier to release the valve clamp 40.

[0043] Optionally, in the embodiments of this application, the locking member 65 and its corresponding elastic member 69 can be symmetrically or asymmetrically arranged about the axis of the connecting assembly 60, preferably symmetrically arranged, so that the overall structure of the connecting assembly 60 is symmetrical and the force is balanced, which helps to ensure the stability of the connecting assembly 60 in connecting the delivery sheath 20 and the valve clamp 40, thereby facilitating the delivery sheath 20 to deliver the valve clamp 40 through the connecting assembly 60. The number of locking members 65 and elastic members 69 can be set to 2, 3, 4, or any other reasonable number. For ease of description, the structure of the connecting assembly 60 and the valve clamping system 1 will be further described below with an example of 2 locking members 65 and 2 elastic members 69.

[0044] Please refer to the following: Figures 9 to 12In this embodiment, the first fixing member 61 is generally a cylindrical structure, and has an axial cavity 612 for the mandrel 67 to pass through it. To ensure that the mandrel 67 can move smoothly in the first axial cavity 612 and to avoid the overall size of the first fixing member 61 being too large, the inner diameter D1 of the first axial cavity 612 (see...) Figure 12 The thickness is set to 2mm-3mm. The first fixing member 61 can be made of, but is not limited to, nickel-titanium alloy, cobalt-chromium alloy, or stainless steel, and its proximal end can be fixedly connected to the distal end of the delivery sheath 20 by either welding or adhesive bonding. In this embodiment, the first fixing member 61 is preferably made of nickel-titanium alloy, and its proximal end is fused to the distal end of the delivery sheath 20.

[0045] like Figures 9 to 12 As shown, the middle portion of the first fixing member 61 has at least two mounting holes 614 communicating with the first axial inner cavity 612. Each mounting hole 614 is used to accommodate and install the proximal end of a corresponding locking member 65 (see Figure 614). Figure 9 In this embodiment, there are two mounting holes 614, symmetrically distributed about the axis of the first fixing member 61. Specifically, each mounting hole 614 is a rectangular through hole, and a pair of sidewalls parallel to the axis of the first fixing member 61 each have a first pin hole. Each first pin hole extends in a direction perpendicular to the axial direction of the first fixing member 61 to penetrate the outer wall of the first fixing member 61. The proximal end of the locking member 65 has a second pin hole. The proximal end of the locking member 65 extends into the corresponding mounting hole 614 to connect the two first pin holes and the second pin hole. A pin or a rotating shaft is inserted from one side of the first fixing member 61 into the connected two first pin holes and the second pin hole to rotatably connect the locking member 65 to the sidewall of the corresponding mounting hole 614, thus rotatably connecting the locking member 65 to the first fixing member 61. When the proximal end of the locking member 65 rotates about the pin or the rotating shaft, the distal end of the locking member 65 moves closer to or further away from the axis of the first fixing member 61. It can be understood that, as Figure 12 As shown, the longer the axial length D2 of the mounting hole 614, the larger the angle range of the proximal end of the locking member 65 relative to the axis of the first fixing member 61 after rotating around the pin or the shaft. In this embodiment, in order to ensure that the proximal end of the locking member 65 can rotate within the angle range of 0 degrees to 90 degrees relative to the axis of the first fixing member 61, preferably 0 degrees to 45 degrees, the axial length D2 of the mounting hole 614 can be set to 2mm to 5mm.

[0046] Please refer to the following: Figure 10 and Figure 13In this embodiment, a notch 618 is formed at the distal end of the first fixing member 61 corresponding to each mounting hole 614. The notch 618 is used to accommodate an elastic member 69 corresponding to a locking member 65 within the mounting hole 614. Specifically, two notches 618 are symmetrically formed at the distal end of the first fixing member 61. Each notch 618 extends from the distal end of the first fixing member 61 to its adjacent mounting hole 614, and each notch 618 communicates with the first axial inner cavity 612. Two elastic members 69 are correspondingly disposed at the two notches 618. By forming notches 618 on the first fixing member 61, at least some of the elastic members 69 can be accommodated, thereby reducing the overall size and weight of the connecting assembly 60.

[0047] Furthermore, such as Figure 10 As shown, in this embodiment, after two notches 618 are symmetrically opened at the distal end of the first fixing member 61, two oppositely spaced lugs are formed at the distal end of the first fixing member 61, and the spacing direction of the two lugs is perpendicular to the spacing direction of the two notches 618. It should be noted that in this embodiment, when the connecting assembly 60 is in the connected state, the proximal end of the second fixing member 63 is at least partially inserted into the distal end of the first axial inner cavity 612, specifically inserted into the space between the two lugs of the first fixing member 61. The proximal end of the second fixing member 63 and the distal end of the first fixing member 61 are engaged through a shaft hole, so that the second fixing member 63 and the first fixing member 61 are coaxially opposite each other. Preferably, at least one set of mutually adapted anti-rotation structures is provided between the proximal end of the second fixing member 63 and the distal end of the first axial inner cavity 612. The anti-rotation structure can prevent the second fixing member 63 and its connected valve clamp 40 from rotating or tilting relative to the first fixing member 61, thereby helping to increase the connection stability of the connecting assembly 60.

[0048] Specifically, please refer to the following: Figure 10 , Figures 14 to 17 At least one of the two lugs located at the distal end of the first axial cavity 612 has at least one first anti-rotation part 616 on its inner wall (see Figure 10 and Figure 14 The proximal end of the second fixing member 63 is provided with a second anti-rotation part 636 corresponding to each first anti-rotation part 616 (see...). Figures 15 to 17At least one first anti-rotation part 616 and its corresponding second anti-rotation part 636 constitute the above-mentioned at least one set of anti-rotation structures. Optionally, one of the first anti-rotation part 616 and the second anti-rotation part 636 is an anti-rotation groove and the other is an anti-rotation block. When the proximal portion of the second fixing member 63 is inserted into the distal end of the first axial inner cavity 612, the anti-rotation block is inserted into the corresponding anti-rotation groove to achieve the anti-rotation effect. In this embodiment, the inner walls of the two lugs are respectively provided with an anti-rotation groove, and the proximal end of the second fixing member 63 is symmetrically provided with two anti-rotation blocks corresponding to the two anti-rotation grooves. The two anti-rotation grooves and the two anti-rotation blocks constitute two sets of anti-rotation structures, which have a better anti-rotation effect.

[0049] It should be noted that, in this embodiment, the inner diameter D1 at the distal end of the first axial inner cavity 612 (see...) Figure 12 The outer diameter D3 of the proximal end of the second fastener 63 (see) Figure 16 The fit tolerance between the two parts is in the range of 0.02mm-0.05mm. Furthermore, the radial dimension D4 between the two groove walls corresponding to the two first anti-rotation parts 616 (i.e., the two anti-rotation grooves) is (see...). Figure 12 The diameter is set to 3.2mm-4.2mm, and the radial dimension D5 between the two outer walls of the two corresponding second anti-rotation parts 636 (i.e., the two anti-rotation blocks) is (see...). Figure 17 The radial dimension D5 is equal to or less than the radial dimension D4, preferably less than the radial dimension D4, so that the anti-rotation block can be easily inserted into the corresponding anti-rotation groove. In this way, by reasonably designing the inner diameter D1 of the first fixing member 61, the outer diameter D3 of the proximal end of the second fixing member 63, and the aforementioned radial dimensions D4 and D5, it can be ensured that the proximal end of the second fixing member 63 can be smoothly inserted into the distal end of the first axial inner cavity 612, and the first fixing member 61 and the second fixing member 63 can maintain a high degree of concentricity, thereby avoiding the second fixing member 63 from tilting and / or being too tight with the first fixing member 61.

[0050] Please refer to it again. Figures 15 to 17 In this embodiment, the second fixing member 63 is generally a stepped shaft structure, comprising a proximal cylindrical segment, a middle cylindrical segment, and a distal cylindrical segment connected in sequence with decreasing diameters. The proximal cylindrical segment is used to connect to the first fixing member 61, and its proximal portion is inserted into the distal end of the first axial cavity 612 (see...). Figure 5 The proximal cylindrical section has a second anti-rotation part 636 (i.e., anti-rotation block) on its proximal peripheral wall; the distal cylindrical section is used to connect to the proximal end of the valve clamp 40. The second fixing member 63 can be made of materials such as, but not limited to, nickel-titanium alloy, cobalt-chromium alloy, or stainless steel, preferably stainless steel. The distal end of the second fixing member 63 can be connected to the proximal end of the valve clamp 40 by welding or gluing.

[0051] like Figure 5As shown, in this embodiment, the second fixing member 63 has a second axial inner cavity 632 that extends through its proximal and distal ends. The second axial inner cavity 632 is connected to the first axial inner cavity 612. The mandrel 67 can be movably inserted into the connected first axial inner cavity 612 and second axial inner cavity 632, and its proximal end extends to the patient's body through the lumen of the delivery sheath 20.

[0052] Furthermore, such as Figures 15 to 17 As shown, at least two slots 634 are provided on the peripheral wall of the proximal end of the second fixation member 63 (i.e., the peripheral wall of the proximal end of the cylindrical segment). Each slot 634 extends radially along the second fixation member 63 to allow the distal end of the corresponding locking member 65 to be inserted, thereby restricting the degree of freedom of the second fixation member 63 and preventing the second fixation member 63 and its connected valve clamp 40 from moving. Optionally, the slot 634 may extend radially to communicate with the second axial cavity 632 or may not communicate with the second axial cavity 632. In this embodiment, two slots 634 are symmetrically provided on the peripheral wall of the proximal end of the second fixation member 63, and each slot 634 extends radially to communicate with the second axial cavity 632. This helps to reduce the weight of the second fixation member 63, thereby reducing the traction effect on the valve after the second fixation member 63 and its connected valve clamp 40 are implanted into the patient's body, and avoiding valve tearing and damage.

[0053] It should be noted that, as Figure 15 As shown, in this embodiment, the spacing direction of the two slots 634 near the end of the second fixing member 63 is perpendicular to the spacing direction of the two anti-rotation blocks (i.e., the second anti-rotation portion 636). Please refer to the following: Figures 18 to 21 When the proximal portion of the second fixing member 63 is inserted into the distal end of the first axial inner cavity 612, each anti-rotation block is inserted into a corresponding anti-rotation groove (i.e., the first anti-rotation part 616), and each slot 634 is located on the same straight line as a mounting hole 614 on the first fixing member 61, so that the distal end of the locking member 65 in the mounting hole 614 can be inserted into the slot 634 of the second fixing member 63, so that the first fixing member 61 and the second fixing member 63 are connected and locked through the locking member 65, and then the delivery sheath 20 and the valve clamp 40 are connected and locked through the connecting assembly 60.

[0054] Each slot 634 can be, but is not limited to, a circular slot or a square slot, as long as the structure of the distal end of the corresponding locking member 65 is compatible with the structure of the slot 634. In this embodiment, each slot 634 is a square slot.

[0055] Please refer to the following: Figure 8 , Figure 9 and Figure 22In this embodiment, the locking member 65 is generally L-shaped, including an insertion section 652 at its distal end, a connecting section 654 at its proximal end, and an intermediate section 656 connecting the insertion section 652 and the connecting section 654. The insertion section 652 is perpendicular or substantially perpendicular to the intermediate section 656. The connecting section 654 is inclined inward relative to the intermediate section 656 (i.e., inclined towards the axis closer to the first fixing member 61), and the end of the connecting section 654 away from the intermediate section 656 has the aforementioned second pin hole, which is used for a pin or shaft to pass through. Figure 9 As shown, the connecting segment 654 of each locking member 65 extends into a mounting hole 614 on the first fixing member 61, and is rotatably connected to the side wall of the mounting hole 614 by a pin or a rotating shaft, so that the locking member 65 can rotate after being connected to the first fixing member 61. Figure 8 As shown, when the connecting assembly 60 is in the connected state, the insertion segment 652 of each locking member 65 is radially inserted into the corresponding slot 634. The middle segment 656 of each locking member 65 is parallel or substantially parallel to the axis of the spindle 67. The connecting segment 654 of each locking member 65 abuts against the surface of the spindle 67 (specifically, the end face of the connecting segment 654 away from the middle segment 656) and is inclined outward relative to the axis of the spindle 67 towards the proximal end of the first fixing member 61. In other words, when the distal end of the locking member 65 is inserted into the second fixing member 63, there is a certain angle between the opposing surfaces of the connecting segments 654 of the two locking members 65. The angle can be any reasonable angle between 9 degrees and 15 degrees, but is preferably 10 degrees.

[0056] As mentioned above, the structure of the distal end of the locking member 65 (i.e., the insertion segment 652) is adapted to the structure of the corresponding slot 634. The structure of the insertion segment 652 can be, but is not limited to, a cylindrical structure or a square structure. In this embodiment, the structure of the insertion segment 652 is a square structure adapted to the square slot 634.

[0057] The locking component 65 can be made of materials such as, but not limited to, nickel-titanium alloy, cobalt-chromium alloy, and stainless steel, and is preferably made of stainless steel.

[0058] Please refer to the following: Figure 5 , Figures 7 to 9 In this embodiment, the mandrel 67 is movably inserted into the communicating first axial cavity 612 and second axial cavity 632, and its proximal end extends to the patient's body through the lumen of the delivery sheath 20. Specifically, as Figures 7 to 9As shown, the mandrel 67 includes a conical segment 672, a cylindrical segment 674 connected to the proximal end of the conical segment 672, and a threaded segment 676 connected to the distal end of the conical segment 672. The diameter of the conical segment 672 gradually decreases from its proximal end to its distal end, the diameter of the cylindrical segment 674 is equal to the diameter of the proximal end of the conical segment 672, and the diameter of the threaded segment 676 is equal to the diameter of the distal end of the conical segment 672. It should be noted that the conical segment 672, cylindrical segment 674, and threaded segment 676 of the mandrel 67 can all be made of materials such as, but not limited to, nickel-titanium alloy, cobalt-chromium alloy, or stainless steel. The three parts of the mandrel 67 can be formed separately and then connected together by welding or gluing, or they can be formed as a single piece. In this embodiment, the mandrel 67 is preferably made of high-hardness stainless steel in one piece.

[0059] like Figure 7 and Figure 8 As shown, when the connecting assembly 60 is in the connected state, the cylindrical section 674 of the spindle 67 abuts against the proximal end of each locking member 65 (i.e., the end face of the connecting section 654 of each locking member 65 away from the middle section 656). The wall surface of the cylindrical section 674 and the end face of the connecting section 654 extending into the first axial inner cavity 612 form point contact. The proximal end of the locking member 65 is restricted and its distal end cannot open outward and remains inserted into the corresponding slot 634, so that the locking member 65 and the second fixing member 63 always remain connected and locked. In turn, the delivery sheath 20 and the valve clamp 40 through the connecting assembly 60 also always remain connected and locked, which can prevent the valve clamp 40 from disengaging during delivery and during the capture and clamping of the valve.

[0060] like Figure 9As shown, when the connecting assembly 60 is in the disengaged state, there is a radial gap between the conical segment 672 of the mandrel 67 and the proximal end of each locking member 65, or the conical segment 672 is withdrawn from the first axial inner cavity 612. The wall surface of the cylindrical segment 674 no longer abuts against the proximal end of each locking member 65, thereby releasing the restriction on the proximal end of the locking member 65. Driven by the corresponding elastic member 69, the proximal end of each locking member 65 rotates and its distal end moves radially away from the second fixing member 63, thus disengaging the locking member 65 from the second fixing member 63. This allows the second fixing member 63 and its connected valve clamp 40 to be released from the delivery sheath 20 and implanted into the patient's body. It should be noted that by controlling the mandrel 67 to retract axially proximally within the first axial inner cavity 612 and the second axial inner cavity 632, a radial gap can be formed between the conical segment 672 and the proximal end of each locking member 65, or the conical segment 672 can be withdrawn from the first axial inner cavity 612, thereby achieving the disengagement of the connecting assembly 60. In this embodiment, by designing the diameter of the cone segment 672 to gradually decrease from the proximal end to the distal end, it can be ensured that there is a smooth process of sliding contact and separation between the locking member 65 and the cone segment 672 during the process of the mandrel 67 retracting to the proximal end. The locking member 65 can be opened relatively uniformly under the drive of the corresponding elastic member 69 until it is completely separated from the second fixing member 63, so that the locking member 65 is disconnected from the second fixing member 63, thereby releasing the connection between the delivery sheath 20 and the valve clamp 40 and releasing the valve clamp 40.

[0061] like Figure 5 As shown, after the delivery sheath 20 is connected to the valve clamp 40 via the connecting assembly 60, the distal end of the threaded section 676 of the mandrel 67 is detachably connected to the drive mechanism 41 of the valve clamp 40. When the mandrel 67 moves axially within the first axial cavity 612 and the second axial cavity 632, the mandrel 67 drives the drive mechanism 41 to open and close the valve clamp 40 to capture and clamp the valve. It can be understood that after the valve clamp 40 successfully clamps the valve, the mandrel 67 is first controlled to move axially to drive the drive mechanism 41 to close the valve clamp 40. Then, the connection between the threaded section 676 and the drive mechanism 41 is released, and then the connecting assembly 60 is released, thus realizing the release and implantation of the valve clamp 40 and its proximal connection to the second fixation member 63. It is also understandable that, as mentioned above, the cylindrical section 674 of the mandrel 67 and the connecting section 654 of the locking member 65, which extends into the first axial inner cavity 612, form a point contact. This helps to reduce the frictional resistance between the mandrel 67 and the proximal end of the locking member 65 during axial movement. At the same time, it ensures that the locking member 65 can remain inserted into the slot 634 of the second fixing member 63 to maintain the connection and locking between the delivery sheath 20 and the valve clamp 40, and to prevent the valve clamp 40 from disengaging before it can successfully clamp the valve.

[0062] Please refer to it again. Figures 8 to 10 and Figure 13 In this embodiment, an elastic element 69 is provided on each locking element 65 on opposite sides of the first fixing member 61. The elastic element 69 is used to drive the corresponding locking member 65, so that the proximal end of the locking member 65 rotates and its distal end pops out from a slot 634 corresponding to the second fixing member 63, so as to release the connection and locking between the locking member 65 and the second fixing member 63, thereby separating the valve clamp 40 from the delivery sheath 20 to release the valve clamp 40.

[0063] Specifically, such as Figure 10 As shown, in this embodiment, each elastic element 69 includes an elastic arm made of elastic material. The proximal end of the elastic arm is connected to the first fixing element 61 (specifically, the portion connected to the proximal end of the first fixing element 61 adjacent to the notch 618), and the distal end of the elastic arm extends outward relative to the first fixing element 61. Each elastic element 69 is correspondingly disposed at a notch 618. Figure 8 As shown, when the connecting assembly 60 is in the connected state, each elastic arm is compressed. Figure 9 As shown, when the connecting assembly 60 is in the disengaged state, the distal end of each elastic arm springs outward to drive the corresponding locking member 65, causing the proximal end of the locking member 65 to rotate and its distal end to radially disengage from the corresponding slot 634, thereby releasing the connection and locking between the locking member 65 and the second fixing member 63. It can be understood that, in order for the elastic member 69 to drive the distal end of the corresponding locking member 65 completely away from the corresponding slot 634, as... Figure 13 As shown, in this embodiment, the maximum distance D7 between the distal end of the elastic arm of each elastic member 69 and the axis of the first fixing member 61 is greater than the sum of the length of the insertion section 652 of the locking member 65 and the radius of the second fixing member 63, and the distance by which the distal end of the elastic arm springs outward is greater than the depth of the slot 634. In this embodiment, the maximum distance D7 between the distal end of the elastic arm and the axis of the first fixing member 61 ranges from 4mm to 5mm.

[0064] The elastic element 69 can be made of, but is not limited to, nickel-titanium alloy, nickel alloy, or titanium alloy. In this embodiment, the elastic element 69 is preferably made of nickel-titanium alloy with shape memory function. The elastic element 69 and the first fixing element 61 are integrally formed and the elastic element 69 is shaped under high temperature conditions. Of course, in other embodiments, the elastic element 69 can also be a separate part and fixed to the first fixing element 61 by welding. It is understood that in order to ensure that the elastic arm of each elastic element 69 has sufficient elastic force to open the corresponding locking element 65, the elastic arm of each elastic element 69 should have a certain wall thickness. Specifically, in this embodiment, the wall thickness of the elastic arm of each elastic element 69 is set to 0.4mm-1.0mm, so that the elastic arm can provide an elastic force of 3N-5N, ensuring that the locking element 65 can be separated from the second fixing element 63 under the drive of this elastic force.

[0065] It should be noted that in other embodiments, the elastic element 69 can also be a spring or a bellows or other types of elastic element, with one end connected to the first fixing member 61 and the other end used to push against the corresponding locking member 65. When the connecting assembly 60 is in the connected state, the elastic element 69, such as the spring, is compressed between the first fixing member 61 and the locking member 65; when the connecting assembly 60 is in the disengaged state, the elastic element 69, such as the spring, springs outward to drive the locking member 65.

[0066] Please refer to it again. Figure 4 and Figure 5 The proximal end of the valve clamp 40 is fixedly connected to the distal end of the second fixing member 63, and its drive mechanism 41 is detachably connected to the distal end of the mandrel 67, so that the valve clamp 40 can be connected, locked or disengaged from the delivery sheath 20 through the connecting assembly 60. When the valve clamp 40 is connected and locked to the delivery sheath 20, the axial movement of the mandrel 67 can drive the drive mechanism 41 to drive the valve clamp 40 to open and close.

[0067] Specifically, such as Figure 4 and Figure 5 As shown, in this embodiment, the valve clamp 40 includes a base 43, a drive mechanism 41, and two clamping portions 45 connected to the base 43 and symmetrically distributed about the axis of the base 43. The drive mechanism 41 connects to each clamping portion 45 to drive the two clamping portions 45 to open and close relative to each other under the drive of the spindle 67, thereby capturing and clamping the valve.

[0068] More specifically, such as Figure 4 and Figure 5As shown, in this embodiment, the distal end of the second fixing member 63 is at least partially inserted into the base 43 and fixedly connected to the base 43 by any of the following methods: welding, gluing, or threaded connection. The drive mechanism 41 includes a drive shaft 412 and two connecting rods 414. The drive shaft 412 axially moves through the base 43 and its proximal end extends into the second axial inner cavity 632. The proximal end of the drive shaft 412 is detachably connected to the threaded section 676 of the spindle 67 by a threaded connection. One end of each connecting rod 414 is connected to the distal end of the drive shaft 412, and the other end is rotatably connected to a corresponding clamping part 45. Each clamping part 45 includes a proximal clamping piece 452, one end of which is fixedly connected to the base 43 and the other end of which can be relatively close to or away from the second fixing member 63, and a distal clamping piece 454, one end of which is rotatably connected to the base 43 and the other end of which is a free end. The proximal clamping piece 452 is located between the second fixing member 63 and the corresponding distal clamping piece 454. Each link 414 can be rotatably connected to a connecting seat (not shown) located at the far end of the drive shaft 412, or it can be directly rotatably connected to the far end of the drive shaft 412; there is no limitation on this.

[0069] In this embodiment, when the mandrel 67 moves axially towards the distal end, the mandrel 67 drives the drive shaft 412 to move towards the distal end, and then drives the two corresponding distal clamps 454 to unfold relative to each other through the two connecting rods 414 so that a valve receiving space is formed between each distal clamp 454 and its corresponding proximal clamp 452 (at this time, the proximal clamp 452 is close to the second fixing member 63). After the valve enters the valve receiving space, the proximal clamp 452 presses against the distal clamp 454 to capture the valve. When the mandrel 67 moves axially towards the proximal end, the mandrel 67 drives the drive shaft 412 to move towards the proximal end, and then drives the two corresponding distal clamps 454 to close relative to each other through the two connecting rods 414 to clamp the captured valve. It should be noted that during the process of the mandrel 67 moving axially to drive the two distal clips 454 of the valve clamp 40 to open and close relative to each other, the proximal end of the locking member 65 always maintains sliding contact with the cylindrical section 674 of the mandrel 67, thereby ensuring that the mandrel 67 does not affect the connection and locking of the locking member 65 to the second fixing member 63 and the valve clamp 40 connected thereto during the movement. In addition, the axial length of the cylindrical section 674 should be greater than the distance that the mandrel 67 needs to move axially to drive the two distal clips 454 of the valve clamp 40 to open and close relative to each other.

[0070] Furthermore, such as Figure 4 As shown, in this embodiment, the two locking members 65 and the two clamping parts 45 of the valve clamp 40 are staggered in the circumferential direction. Preferably, the directions in which the two locking members 65 are arranged opposite each other are perpendicular to the directions in which the two clamping parts 45 are arranged opposite each other. In this way, the clamped valve can be prevented from interfering with the two elastic members 69 driving the corresponding locking members 65 to separate from the second fixing member 63, ensuring that the valve clamp 40 can be successfully released from the delivery sheath 20 after clamping the valve.

[0071] It is understood that the valve clamp 40 in the above embodiments includes two clamping portions 45 for capturing and clamping two valves. In other embodiments, the number of clamping portions 45 may be set to three or more reasonable numbers to capture and clamp more than two valves, and there is no limitation thereto. It is also understood that the description of the above embodiments only describes part of the structure of the valve clamp 40, but the valve clamp 40 also includes some other components, such as barbs disposed on at least one proximal clamp 452, and a locking component disposed in the inner cavity of the base 43. The barbs are used to anchor into the valve to enhance the reliability of the clamping portion 45 clamping the valve, and the locking component is used to lock the position of the drive shaft 412 after the valve clamp 40 successfully clamps the valve to prevent the clamped valve from loosening. The specific structure of the valve clamp 40 is basically similar to the structure of the valve clamp in the prior art, and will not be described in detail here.

[0072] In addition, it should be noted that the delivery sheath 20 can be an adjustable bend sheath commonly used in the prior art. The valve clamping system 1 also includes a control handle connected to the proximal end of the delivery sheath 20. The proximal end of the spindle 67 is connected to the control handle. The control handle is used to control the axial movement and bending of the delivery sheath 20, as well as the axial movement and rotation of the spindle 67. The specific structure of the delivery sheath 20 and the control handle is basically similar to the structure of the sheath and control handle in the prior art, and will not be described in detail here.

[0073] Please refer to the following: Figure 3 , Figures 23 to 25 The following will use the mitral valve repair process as an example to illustrate the operation method of the valve clipping system 1 provided in this application, which mainly includes the following steps:

[0074] Step 1: The second fixing member 63 is engaged with the first fixing member 61 through a shaft hole, that is, the proximal part of the second fixing member 63 is inserted into the distal end of the first axial inner cavity 612, so that the second anti-rotation part 636 engages with the first anti-rotation part 616, and an external force is applied to each locking member 65 to make the proximal end of each locking member 65 move and its distal end is inserted into a corresponding slot 634.

[0075] Step 2: Push the mandrel 67 axially towards the distal end using the control handle, allowing its distal end to sequentially move through the lumen of the delivery sheath 20, the first axial inner cavity 612, and the second axial inner cavity 632. Then rotate the mandrel 67 so that its distal end is threadedly connected to the drive shaft 412 of the valve clamp 40. At this time, the cylindrical section 674 of the mandrel 67 abuts against the proximal end of the locking member 65, thus restricting the locking member 65. Figure 3 As shown, the valve clamp 40 is connected and locked to the delivery sheath 20 via the connecting assembly 60.

[0076] Step 3: Using a transcatheter intervention, the delivery sheath 20 is pushed distally along the axial direction by the control handle to deliver the valve clamp 40 to the mitral valve accessory. Then, the mandrel 67 is moved axially by the control handle to drive the valve clamp 40 to open and close, thereby capturing and clamping the anterior and posterior leaflets of the mitral valve. During this process, the proximal end of the locking member 65 maintains sliding contact with the cylindrical section 674 of the mandrel 67 to keep the valve clamp 40 connected to the delivery sheath 20.

[0077] Step 4: After confirming that the valve clamp 40 has successfully clamped the valve and that the clamping position is correct, disconnect the mandrel 67 from the drive shaft 412. Using the control handle, retract the mandrel 67 axially proximally to remove it from the first axial inner cavity 612. At this time, as... Figure 23 As shown, the proximal end of the locking member 65 is no longer restricted by the spindle 67, and the elastic arm of each elastic member 69 drives the proximal end of the corresponding locking member 65 to rotate. The distal end of the locking member 65 moves radially away from the slot 634 of the second fixing member 63 until the locking member 65 separates from the second fixing member 63 (as shown). Figure 24 As shown), the connection between the valve clamp 40 and the delivery sheath 20 is released, and the valve clamp 40 and its proximal connection to the second fixation member 63 are released and implanted into the patient's body (as shown). Figure 25 (As shown).

[0078] Step 5: Remove the delivery sheath 20 and connecting components 60 except for the second fixing member 63, and complete the edge-to-edge clamping repair of the anterior and posterior leaflets of the mitral valve, thereby treating mitral regurgitation.

[0079] It should be noted that in the above embodiments, the description of the connecting component 60 is based on the example of the connecting component 60 being used to connect the delivery sheath 20 and the valve clamp 40. In other embodiments, the connecting component 60 provided in this application can also be used to connect the delivery sheath 20 and other medical implants other than the valve clamp 40 that need to be delivered through the delivery sheath 20, such as, but not limited to, left atrial appendage occluders, vascular plugs, and heart defect occluders. Any of the aforementioned medical implants can be connected, locked, and released from the delivery sheath 20 through the connecting component 60.

[0080] It is understood that when the spindle 67 in the connecting assembly 60 is only used to restrict the proximal end of the locking member 65, the spindle 67 may only include a cylindrical section 674 and a conical section 672 connected to the distal end of the cylindrical section 674, making the structure of the spindle 67 simpler. Correspondingly, the second fixing member 63 may or may not have a second axial inner cavity 632, and there is no limitation on this.

[0081] The above are the implementation methods of the embodiments of this application. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the embodiments of this application, and these improvements and modifications are also considered to be within the protection scope of this application.

Claims

1. A connecting assembly for connecting a delivery sheath and a medical implant, characterized in that, include: The first fixing member has its proximal end fixedly connected to the distal end of the delivery sheath, and it has a first axial inner cavity; The second fastener has its distal end fixedly connected to the proximal end of the medical implant; At least two locking members, the proximal end of each locking member being rotatably connected to the first fixing member and partially extending into the first axial cavity; The mandrel is movably inserted into the first axial inner cavity; and At least two elastic elements, one of which is disposed between the locking element and the first fixing element; The connecting assembly has a connected state and a disengaged state; in the connected state, the mandrel abuts against the proximal end of each of the locking members, such that the distal end of each of the locking members remains radially inserted into the second fixing member; in the disengaged state, there is a radial gap between the mandrel and the proximal end of each of the locking members, or the mandrel is withdrawn from the first axial cavity, and each of the elastic members drives the corresponding locking member, such that the proximal end of each of the locking members rotates, and the distal end of each of the locking members moves radially away from the second fixing member.

2. The connection component as claimed in claim 1, characterized in that, The at least two locking elements and the at least two elastic elements are symmetrically arranged about the axis of the connecting assembly.

3. The connection component as claimed in claim 1, characterized in that, The mandrel includes a conical segment and a cylindrical segment connected to the proximal end of the conical segment. The diameter of the conical segment gradually decreases from its proximal end to its distal end, and the diameter of the cylindrical segment is equal to the diameter of the proximal end of the conical segment. In the engaged state, the cylindrical segment abuts against the proximal end of each of the locking elements. In the disengaged state, there is a radial gap between the conical segment and the proximal end of each of the locking elements, or the conical segment is withdrawn from the first axial cavity.

4. The connection component as claimed in claim 1, characterized in that, At least two slots are provided on the peripheral wall of the proximal end of the second fastener, each slot extending radially along the second fastener; each locking member has an insertion segment at its distal end; in the connected state, one of the insertion segments remains radially inserted into a corresponding slot.

5. The connection component as claimed in claim 4, characterized in that, Each of the locking elements further includes a connecting segment located at its proximal end, and an intermediate segment connecting the insertion segment and the connecting segment; the connecting segment is inclined inward relative to the intermediate segment, and the insertion segment is perpendicular or substantially perpendicular to the intermediate segment; In the connected state: the surface of the connecting section abutting the mandrel is inclined outward relative to the axis of the mandrel and towards the proximal end of the first fixing member; the middle section is parallel to or substantially parallel to the axis of the mandrel.

6. The connection component as claimed in claim 5, characterized in that, In the connected state, the elastic element is compressed; in the released state, the elastic element springs outward, the maximum distance between the axis of the elastic element and the first fixing element is greater than the sum of the length of the insertion segment and the radius of the second fixing element, and the distance the elastic element springs outward is greater than the depth of the slot.

7. The connection component as claimed in claim 5, characterized in that, The elastic element includes an elastic arm, the proximal end of which is connected to the first fixing element, and the distal end of which extends outward relative to the first fixing element. In the connected state, the elastic arm is compressed; In the released state, the distal end of the elastic arm springs outward, and the maximum distance between the distal end of the elastic arm and the axis of the first fixing member is greater than the sum of the length of the insertion segment and the radius of the second fixing member. The distance by which the distal end of the elastic arm springs outward is greater than the depth of the slot.

8. The connection component as claimed in claim 1, characterized in that, The middle portion of the first fixing member has at least two mounting holes that communicate with the first axial inner cavity, and one of the mounting holes is used to accommodate and install the proximal end of the corresponding locking member; The locking member is rotatably connected to the side wall of the corresponding mounting hole via a pivot or pin, and the axial direction of the pivot or pin is perpendicular to the axial direction of the first fixing member.

9. The connection component as claimed in claim 1, characterized in that, In the connected state, the proximal end of the second fixing member is at least partially inserted into the distal end of the first axial inner cavity, and at least one set of mutually adapted anti-rotation structures are provided between the proximal end of the second fixing member and the distal end of the first axial inner cavity.

10. The connection component as claimed in claim 9, characterized in that, The fit tolerance between the distal inner diameter of the first axial cavity and the proximal outer diameter of the second fastener ranges from 0.02mm to 0.05mm.

11. A valve clamping system, characterized in that, Includes a delivery sheath, a valve clamp, and a connection assembly as described in any one of claims 1 to 10; The proximal end of the first fixing member is fixedly connected to the distal end of the delivery sheath, and the distal end of the second fixing member is fixedly connected to the proximal end of the valve clamp. The second fixing member has a second axial cavity that communicates with the first axial cavity. The mandrel can be movably inserted into the first axial cavity and the second axial cavity. The valve clamp includes a drive mechanism, and the distal end of the mandrel is detachably connected to the drive mechanism; When the mandrel moves axially within the first and second axial inner cavities, the mandrel drives the drive mechanism to open and close the valve clamp.

12. The valve clamping system as described in claim 11, characterized in that, The valve clamp includes at least two clamping portions connected to the drive mechanism, and the at least two clamping portions and the at least two locking members are staggered in the circumferential direction.

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