Valve Clipping System

Abstract

The present invention discloses a valve clamping system, including a valve clamping device and a clamping state monitoring device, wherein the valve clamping device includes a catheter, a valve clamping mechanism, and a clamping handle mechanism; a control rod is arranged in the catheter, and the distal end of the control rod is detachably connected to the valve clamping mechanism, and the proximal end is connected to the clamping handle mechanism; the clamping state monitoring device includes a blood pressure collection mechanism and a blood pressure analysis and judgment mechanism; the valve clamping mechanism includes a connecting component, a clamping component, a driving component, and a locking component; the clamping component includes a clamping arm and a clamping sheet; the driving component includes a clamping arm driving component and a clamping sheet driving component, the clamping arm is unfolded by the clamping arm driving component and is attached to the clamping sheet to clamp the valve leaflet, and is gathered into a bundle by the clamping arm driving component; the clamping sheet driving component gathers the freely unfolded clamping sheet into a bundle toward the center. The present invention accurately determines whether the clamping is appropriate by real-time monitoring of atrial blood pressure, improves the success rate of the operation, stabilizes the clamping locking, and easily realizes the recovery of the clamping mechanism.

Description

Technical Field

[0001] The invention belongs to the technical field of interventional medical devices and relates to a valve clamping system. Background Art

[0002] Mitral regurgitation is one of the most common valvular diseases today. The main causes include mitral ring dilatation, chordae insufficiency, mitral myxoma degeneration, leaflet prolapse, rheumatic valvular heart disease, ischemic lesions, etc. Mitral valvuloplasty and artificial valve replacement are the most effective methods for treating mitral regurgitation. However, since the operation requires extracorporeal circulation technology support, it causes great trauma to the human body. For elderly patients and patients with more comorbidities, there are relatively high complications and mortality rates. Therefore, in recent years, medical personnel and researchers in various countries have explored transcatheter mitral valve repair technology. The main interventional treatment methods include annuloplasty, negative pressure suction suture technology and mitral valve clamping, among which mitral valve clamping has the most reliable effect. The mitral valve clamp delivers an implantable clip to the vicinity of the mitral valve through atrial septal puncture, clamps and fixes the free edges of the anterior and posterior leaflets, so that the leaflets are well aligned at the end of contraction and regurgitation is reduced.

[0003] In implementing this technology, there are the following problems:

[0004] 1. Determining whether the position and degree of clamping of the mitral valve clamping device are appropriate is the key to implementing this technology. If the degree of clamping is too large, stenosis will occur. On the contrary, if the degree of clamping is too small, the clamping is insufficient and regurgitation still exists. The existing technology uses ultrasonic equipment for monitoring, but the data is not accurate enough and is difficult to use as a basis for judgment.

[0005] 2. In the existing mitral valve clamping procedure, one technical solution is that the cusp valve clamp delivers an implantable clip to the vicinity of the mitral valve through atrial septal puncture, clamps and fixes the free edges of the anterior and posterior leaflets, so that the leaflets are well aligned at the end of contraction and regurgitation is reduced. However, the mitral valve clamp cannot complete a 180° reversal to form a straight line, which makes the mitral valve clamp always at a reverse angle to the leaflets and chordae tendineae, making it easy to get caught on the chordae tendineae and unable to be recovered into the catheter. Another technical solution is that the clamp arm of the mitral valve clamp and its clamp arm connection are both formed of elastic materials with shape memory function, and the clamp arm completely relies on the elasticity of the material to provide clamping force when clamping, and this clamping locking force is poor. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a valve clamping system that can accurately determine whether the clamping is appropriate by real-time monitoring of atrial blood pressure, improve the success rate of the operation, ensure stable clamping locking, and easily realize the recovery of the clamping mechanism in view of the defects of the prior art.

[0007] The technical solution adopted by the present invention to solve its technical problem is:

[0008] A valve clamping system, comprising a valve clamping device and a clamping state monitoring device, wherein the valve clamping device comprises a catheter, a valve clamping mechanism arranged at the distal end of the catheter, and a clamping handle mechanism arranged at the proximal end of the catheter; a control rod is inserted into the catheter, the distal end of the control rod is detachably connected to the valve clamping mechanism, and the proximal end of the control rod is connected to the clamping handle mechanism, and the control rod is operated by the clamping handle mechanism to drive the valve clamping mechanism to achieve valve clamping;

[0009] The clamping state monitoring device at least includes a blood pressure collection mechanism provided on the valve clamping mechanism or at the distal end of the catheter, and a blood pressure analysis and judgment mechanism for analyzing the blood pressure information collected by the blood pressure collection mechanism;

[0010] The valve clamping mechanism comprises a connecting assembly for detachably connecting with the control rod and the distal end of the catheter, a clamping assembly for clamping the valve leaflet, a driving assembly for driving the clamping assembly to open and close, and a locking assembly for locking the action of the driving assembly;

[0011] The clamping assembly comprises a clamping arm and a clamping sheet for clamping the valve leaflet;

[0012] The driving assembly includes a clamp arm driving component connected to the control rod and a clamping plate driving component inserted into the catheter, wherein the clamp arm is unfolded by the clamp arm driving component and adheres to the clamping plate to clamp the leaflet, and is flipped and gathered into a bundle by the clamp arm driving component; the clamping plate driving component gathers the freely unfolded clamping plates into a bundle toward the center.

[0013] Furthermore, in the valve clamping system, the blood pressure collection mechanism preferably includes a pressure sensor and a connecting tube buried in the inner wall of the distal end of the catheter, and both ends of the connecting tube are respectively connected to the pressure sensor and the outside of the catheter to measure the blood pressure outside the distal end of the catheter.

[0014] Furthermore, in the valve clamping system, preferably, a connecting wire is embedded in the inner wall of the catheter, or a connecting wire is inserted into the catheter;

[0015] The distal end of the connecting line is connected to the pressure sensor, and the proximal end of the connecting line is connected to the blood pressure analysis and judgment mechanism.

[0016] Furthermore, in the valve clamping system, a monitoring channel is preferably provided in the catheter, and the blood pressure collection mechanism includes a monitoring shell arranged at the distal end of the monitoring channel, a pressure sensor arranged in the monitoring shell, and a connecting tube, wherein both ends of the connecting tube are respectively connected to the pressure sensor and the outside of the catheter to measure the blood pressure outside the distal end of the catheter.

[0017] Furthermore, in the valve clamping system, the blood pressure collection mechanism preferably includes a pressure sensor, and the pressure sensor is fixedly connected to a guide wire passing through the distal end of the catheter.

[0018] Furthermore, in the valve clamping system, the clamping arms preferably include at least one group of outer clamping arms and at least one group of inner clamping arms, each group of the outer clamping arms includes two outer clamping arms symmetrically arranged, and each group of the inner clamping arms includes two inner clamping arms symmetrically arranged;

[0019] The inner clamp arm and the outer clamp arm are at least partially rigid structures, the inner end of each inner clamp arm is rotatably connected to the upper hinge support, the inner end of each outer clamp arm is rotatably connected to the lower hinge support, and the outer ends of the inner clamp arm and the outer clamp arm on the same side are rotatably connected;

[0020] Alternatively, the inner clamp arm and / or the outer clamp arm are made of elastic material, the inner end of each inner clamp arm is fixedly connected to the upper hinge support, the inner end of each outer clamp arm is fixedly connected to the lower hinge support, and the outer ends of the inner clamp arm and the outer clamp arm on the same side are fixedly connected or an integral structure.

[0021] Furthermore, in the valve clamping system, the clamping piece is preferably elastically fixed to the connecting component; in a free state, the clamping piece extends outward and cooperates with the unfolded clamping arm to clamp the valve leaflet.

[0022] Furthermore, in the valve clamping system, the clamp arm driving member is preferably a driving rod, which passes through the connecting assembly, the upper hinge support and the lower hinge support, and drives the lower hinge support to move up and down to drive the clamp arm to fold or unfold.

[0023] Furthermore, in the valve clamping system, the locking assembly is preferably fixedly connected to the connecting assembly, and the locking assembly locks the up and down movement of the driving rod, thereby locking the clamping arm.

[0024] Furthermore, in the valve clamping system, the clamping plate driving member is preferably installed in a catheter, and the distal end of the clamping plate driving member is connected to the free end of the clamping plate, and the proximal end is connected to the clamping handle mechanism, and the clamping plate driving member pulls the clamping plates to be gathered into a bundle.

[0025] Furthermore, in the valve clamping system, the clamping plate driving member is preferably a wire, a thread or a rod made of a flexible material.

[0026] Furthermore, in the valve clamping system, the locking assembly preferably includes a lock seat, a lock member, an elastic member, an unlocking member, and an unlocking control member, the lock member and the elastic member are both arranged in the lock seat, the lock seat is fixedly connected to the connecting assembly, the clamp arm driving member passes through the lock seat, the lock member and the elastic member, and the lock member and the elastic member are limited by the clamp arm driving member and the lock seat;

[0027] The elastic member pushes the locking member to clamp the clamp arm driving member, and the clamp arm driving member is locked;

[0028] The unlocking member is slidably matched with the lock seat, and pushes the locking member and the elastic member to move, the elastic member is deformed, and the locking member releases the clamping of the clamp arm driving member;

[0029] The unlocking control member is installed in the catheter, with its proximal end connected to the clamping handle mechanism and its distal end connected to the unlocking member.

[0030] Furthermore, in the valve clamping system, the connecting component preferably includes a first connecting member fixedly connected to the distal end of the catheter and a second connecting member fixed on the locking component, and the first connecting member and the second connecting member are connected together by snapping or concave-convex fitting.

[0031] Furthermore, in the valve clamping system, preferably, the first connector and the second connector are tubular structures; the distal end of the control rod is directly detachably fixedly connected to the clamping assembly, or is detachably connected to the clamping assembly via a sliding rod.

[0032] Furthermore, in the valve clamping system, the unlocking control member is preferably a wire, a thread or a rod made of a flexible material.

[0033] The present invention has the following beneficial effects:

[0034] The present invention adopts two major devices, namely, a valve clamping device and a clamping state monitoring device. The clamping state monitoring device collects atrial blood pressure through a blood pressure collection mechanism, monitors the clamping process, clamping position, and clamping degree, to avoid stenosis caused by excessive clamping degree, and to avoid the problem of reflux caused by insufficient clamping when the clamping degree is too small. At the same time, in the valve clamping device, the clamping assembly can provide a stable and reliable locking force after clamping, reducing the risk of the clamping device falling off; the clamping assembly can be flipped, and when the valve clamping device needs to be recovered, the clamping assembly can be driven to flip, and the entire clamping assembly is in a straight length state, and there will be no reverse angle to hook the chordae, so that the valve clamping device can be easily freed from the chordae plexus for recovery. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:

[0036] Figure 1 is a schematic structural diagram of an embodiment of the present invention;

[0037] Figure 2 is a schematic structural diagram of a valve clamping device according to an embodiment of the present invention;

[0038] Figure 3-5 It is a structural schematic diagram of three states of the first implementation mode of the clamping assembly according to an embodiment of the present invention;

[0039] Figure 6-7 is a structural schematic diagram of a second implementation mode of a clamping assembly according to an embodiment of the present invention;

[0040] Figure 8-9 is a structural schematic diagram of a third implementation mode of a clamping assembly according to an embodiment of the present invention;

[0041] Figure 10-12 It is a structural schematic diagram of a first implementation mode of a locking assembly according to an embodiment of the present invention;

[0042] Figure 13-15 It is a structural schematic diagram of a second implementation mode of the locking assembly according to an embodiment of the present invention;

[0043] Figure 16-18 It is a structural schematic diagram of a third implementation mode of the locking assembly according to an embodiment of the present invention;

[0044] Figure 19-21 is a schematic diagram of the structure of a connection assembly according to an embodiment of the present invention;

[0045] Fig. 22 It is a structural schematic diagram of another implementation manner of the connection component of an embodiment of the present invention;

[0046] Figure 23-24 It is a structural schematic diagram of a first implementation mode of a blood pressure collection mechanism according to an embodiment of the present invention;

[0047] Fig.25 is a structural schematic diagram of a second implementation of the blood pressure collection mechanism according to an embodiment of the present invention;

[0048] Fig.26 is a schematic structural diagram of a pressure sensor according to an embodiment of the present invention;

[0049] Fig. 27 is a structural schematic diagram of a third implementation mode of the blood pressure collection mechanism according to an embodiment of the present invention;

[0050] Figure 28-31 It is a structural schematic diagram of the implementation process of the embodiment of the present invention. DETAILED DESCRIPTION

[0051] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, specific embodiments of the present invention are now described in detail with reference to the accompanying drawings.

[0052] When a component is referred to as being “fixed to” or “disposed on” another component, it may be directly or indirectly located on the other component. When a component is referred to as being “connected to” another component, it may be directly or indirectly connected to the other component.

[0053] The directions or positions indicated by the terms "upper", "lower", "left", "right", "front", "back", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc. are based on the directions or positions shown in the drawings and are only for the convenience of description and cannot be understood as limitations on the technical solution. The terms "first", "second", etc. are only used for the convenience of description and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. "Multiple" means two or more, unless otherwise clearly and specifically defined.

[0054] like Figure 1-27 As shown, a valve clamping system includes a valve clamping device and a clamping state monitoring device, wherein the valve clamping device includes a catheter 2, a valve clamping mechanism 1 arranged at the distal end of the catheter 2, and a clamping handle mechanism 3 arranged at the proximal end of the catheter 2; a control rod 4 is inserted into the catheter 2, and the distal end of the control rod 4 is detachably connected to the valve clamping mechanism 1, and the proximal end is connected to the clamping handle mechanism 3, and the control rod 4 is operated by the clamping handle mechanism 3 to drive the valve clamping mechanism 1 to achieve valve clamping; the clamping state monitoring device at least includes a blood pressure collecting mechanism 5 arranged on the valve clamping mechanism 1 or at the distal end of the catheter 2, and a blood pressure analysis and judgment mechanism 6 for analyzing the blood pressure information collected by the blood pressure collecting mechanism 5; the blood pressure analysis and judgment mechanism 6 converts the collected blood pressure information data into specific numerical values ​​or diagrams that are easy for medical staff to read and identify, so as to judge whether the clamping degree is appropriate. The blood pressure analysis and judgment mechanism 6 can adopt existing technology, which will not be repeated here. The valve clamping mechanism 1 includes a connecting component 10 for detachably connecting with the control rod 4 and the distal end of the catheter 2, a clamping component 20 for clamping the valve leaflets, a driving component 30 for driving the clamping component 20 to open and close, and a locking component 40 for locking the action of the driving component 30; the clamping component 20 includes a clamping arm 210 and a clamping plate 220 for cooperating in clamping the valve leaflets; the driving component 30 includes a clamping arm driving member connected to the control rod 4 and a clamping plate driving member 310 inserted into the catheter 2, wherein the clamping arm 210 is unfolded by the clamping arm driving member and is attached to the clamping plate 220 to clamp the valve leaflets, and is flipped and gathered into a bundle by the clamping arm driving member; the clamping plate driving member 310 gathers the freely unfolded clamping plate 220 into a bundle toward the center.

[0055] The main structures of the present invention include: a valve clamping device and a clamping state monitoring device.

[0056] The main structures of the valve clamping device are: a catheter 2 , a valve clamping mechanism 1 , a clamping handle mechanism 3 , and a control rod 4 . The clamping handle mechanism 3 is connected to control the valve clamping mechanism 1 through the control rod 4 .

[0057] The catheter 2 is a pipeline for transporting and communicating, wherein a plurality of lumens are provided for inserting guide wires, control rods 4 and other components. The plurality of lumens may be connected or not connected, and at least two lumens are used in this embodiment. The catheter 2 may adopt the existing technology, which will not be described in detail here.

[0058] like Figure 1-2 As shown, the valve clamping mechanism 1 includes a connecting component 10, a clamping component 20, a driving component 30, and a locking component 40. The connecting component 10 is used to be detachably connected to the control rod 4 and the distal end of the catheter 2, the clamping component 20 is used to clamp the leaflet, the driving component 30 is used to drive the clamping component 20 to open and close, and the locking component 40 is used to lock the action of the driving component 30.

[0059] The clamping assembly 20 includes a clamping arm 210 and a clamping sheet 220 for clamping the leaflet. The clamping arm 210 is a symmetrical structure, which requires left-right symmetry to facilitate the same clamping force on the left and right. The clamping arm 210 includes at least one group of outer clamping arm groups and at least one group of inner clamping arm groups. Each group of the outer clamping arm groups includes two outer clamping arms 212 that are symmetrically arranged on the left and right, and each group of the inner clamping arm groups includes two inner clamping arms 211 that are symmetrical on the left and right. In the clamping arm 210, one group of outer clamping arm groups and one group of inner clamping arm groups can be set, and two or more groups of outer clamping arm groups and inner clamping arm groups can be set in parallel. The inner clamping arm 211 has a certain width in the horizontal direction, forming a clamping plane, which is clamped with the clamping sheet 220. The function of the outer clamping arm 212 is mainly to support the inner clamping arm 211. Its specific structure is not limited. Preferably, the outer clamping arm 212 can be a rod-type structure, a strip structure, a frame structure, or a sheet with a certain width.

[0060] The clamp arm 210 structure has multiple implementations:

[0061] like Figure 2-7 As shown, the first embodiment is: the inner clamp arm 211 and the outer clamp arm 212 are at least partially rigid structures; specifically, the inner clamp arm 211 and the outer clamp arm 212 are both rigid structures, or one of the inner clamp arm 211 and the outer clamp arm 212 is a rigid structure, preferably the inner clamp arm 211 is a rigid structure, and the inner clamp arm 211 and the outer clamp arm 212 can also be a composite structure formed by a rigid structure and an elastic structure, for example, the part that cooperates with the clamping sheet is rigid, and the rest is an elastic structure, or the inner clamp arm is a rigid frame with an elastic material, etc. The upper hinge support 230 and the lower hinge support 240 are the rotation center of the clamping mechanism 20, wherein the upper hinge support 230 is fixedly connected to the locking assembly 40, and the lower hinge support 240 moves up and down as the clamp arm 210 extends or retracts. The upper hinge support 230 and the lower hinge support 240 play a connecting role, and their structures are not limited.

[0062] The inner side end of each inner clamp arm 211 is rotatably connected to the upper hinge support 230, and the inner side end of each outer clamp arm 212 is rotatably connected to the lower hinge support 240. The outer side ends of the inner clamp arm 211 and the outer clamp arm 212 on the same side are rotatably connected; that is, the upper hinge support 230 is the connection and rotation center of the two inner clamp arms 211, and the lower hinge support 240 is the connection and rotation center of the two outer clamp arms 212. The upper hinge support 230 and the lower hinge support 240 correspond to each other up and down and are located at the symmetry center (the symmetry center is the symmetry center of the clamping assembly). Preferably, the inner clamp arm 211 and the outer clamp arm 212 are symmetrically arranged about the upper hinge support 230 and the lower hinge support 240, respectively, and the structures of the two inner clamp arms 211 and the two outer clamp arms 212 are also symmetrical to each other. Both ends of the inner clamp arm 211 and the outer clamp arm 212 are rotatably connected, that is, hinged.

[0063] like Figure 3 As shown, it is the initial state of the clamping assembly 20, that is, the state where the clamping assembly 20 is located in the catheter 2, and the inner clamping arm 211 and the outer clamping arm 212 are stacked and folded together, as shown in FIG. Figure 4 The figure shows the unfolded state of the clamping assembly 20. When unfolded, when the clamp arm 210 is at the maximum unfolding angle, the angle between the inner clamp arm 211 and the outer clamp arm 212 (the angle between the inner clamp arm 211 and the outer clamp arm 212 facing the driving rod 320) is not less than 90°. At this time, the inner clamp arm 211 facing the clamping sheet 220 will not hook the tendons at a reverse angle, which can ensure that the valve clamping device can be easily detached from the tendons; preferably, the angle between the inner clamp arm 211 and the outer clamp arm 212 is above 120°, preferably above 160°. Figure 5 The figure shows the clamping assembly 20 in a flipped and folded state. When folded, the two inner clamping arms 211 rotate toward each other and fit together at the center (upper hinge support 230), driving the two outer clamping arms 212 to fold toward the center (lower hinge support 240). The two inner clamping arms 211 and the two outer clamping arms 212 are each folded into a bundle, and the entire clamping assembly 210 is in a straight length state, and there will be no reverse angle to hook the tendon cord, which is convenient for collection into the catheter 2.

[0064] Reference Figure 2-5 The inner clamp arm 211 and the outer clamp arm 212 are both rigid structures. The inner clamp arm 211 is connected to the upper hinge support 230 through a first pin 83, and the outer clamp arm 212 is connected to the lower hinge support 240 through a second pin 82. The inner clamp arm 211 and the outer clamp arm 212 are connected through a third pin 81. The components are rotatably connected through pins, thereby realizing the free rotation of the inner clamp arm 211 and the outer clamp arm 212, thereby realizing the function of the present invention.

[0065] Reference Figure 6-7The inner clamp arm 211 is a rigid structure, the outer clamp arm 212 and the lower hinge support 240 are integrally formed by elastic material, and the inner end of the inner clamp arm 211 is connected to the upper hinge support 230 through a third pin 81; wherein the elastic material is preferably nickel-titanium alloy material.

[0066] The second implementation method is: Figure 8-9 As shown, the inner clamp arm 211 and the outer clamp arm 212 are elastic material pieces. The elastic material piece described in the present invention is a structure with a certain rigidity and can be bent, straightened and other deformations, and can be made of metal materials or polymer materials. Since it can be deformed, the inner clamp arm 211 and the outer clamp arm 212, the inner clamp arm 211 and the upper hinge support 230, and the outer clamp arm 212 and the lower hinge support 240 can be fixedly connected, an integral structure, or rotatably connected. The inner end of each inner clamp arm 211 is fixedly connected to the upper hinge support 230, and the inner end of each outer clamp arm 212 is fixedly connected to the lower hinge support 240. The outer ends of the inner clamp arm 211 and the outer clamp arm 212 on the same side are fixedly connected or an integral structure. Refer to Figure 8-9 The inner clamp arm 211, the outer clamp arm 212 and the lower hinge support 240 are an integrated structure formed by elastic material, wherein the elastic material is preferably nickel-titanium alloy material.

[0067] like Figure 2 , 4 As shown in Figures 6 and 7, the clamping sheet 220 cooperates with the inner clamping arm 211 to clamp the leaflet. The clamping sheet 220 is a sheet-like structure, and its width is substantially the same as that of the inner clamping arm 211. The fixed end of the clamping sheet 220 is fixedly connected or detachably connected to the upper hinge support 230. At least the fixed end of the clamping sheet 220 can be bent and restored. When there is no external force, the clamping sheet 220 itself will automatically unfold and cooperate with the inner clamping arm 211 to clamp the clamping sheet 220, which is preferably elastically fixed to the connecting component 10 or the locking component 40. In the free state, the clamping sheet 220 extends outward and cooperates with the unfolded clamping arm 210 to clamp the leaflet. Driven by the clamping sheet driving member 310, the upper hinge support 230 is folded, and the clamping sheet 220 is folded into a bundle, which is convenient for receiving the catheter 2. In order to clamp better, the surface of the clamping piece 220 is provided with barbs, reinforcing ribs, reinforcing sheets and other structures. In this embodiment, an inclined reinforcing sheet 221 is provided. When clamping, the reinforcing sheet 221 is compressed and deformed to form a reaction force, thereby forming a stronger clamping force.

[0068] like Figure 2 As shown, the driving assembly 30 includes a clamp arm driving member and a clamping piece driving member 310 .

[0069] The clamp arm driving member is specifically a driving rod 320, which penetrates the connecting assembly 10, the locking assembly 40, the upper hinge support 230 and the lower hinge support 240, and drives the lower hinge support 240 to move up and down to drive the clamp arm 210 to clamp or unfold. The driving rod 320 is detachably connected to the control rod 4. The driving rod 320 and the lower hinge support 240 can be fixedly connected or detachably connected. The detachable connection includes screw connection, clamping connection, etc.

[0070] Specifically, refer to Figure 3-5 By controlling the extension length of the driving rod 320 to push the lower hinge support 240 up and down, the expansion angle of the clamping arm 210 can be changed. Figure 3 In the embodiment, the clamping arm 210 is in a clamping state, at which time the driving rod 320 pulls the lower hinge support 240 upward to move to the highest point, and the angle between the inner clamping arm 211 and the outer clamping arm 212 approaches 0; Figure 4 In the process, the driving rod 320 pushes the lower hinge support 240 to move downward, at which time the inner clamp arm 211 and the outer clamp arm 212 are opened at a certain angle, and the inner clamp arm 211 is pulled downward to open; the lower hinge support 240 is further pushed downward, and the clamp arm 210 turns over after reaching the maximum open state and is folded together, see Figure 5 At this time, the driving rod 320 pushes the lower hinge support 240 to move downward to the lowest point, and the angle between the inner clamp arm 211 and the outer clamp arm 212 is close to 180°.

[0071] like Figure 1-2 As shown, the clamping sheet driving member 310 is installed in the catheter 2, and the distal end of the clamping sheet driving member 310 is connected to the free end of the clamping sheet 220, and the proximal end is connected to the clamping handle mechanism 3, and the clamping sheet driving member 310 pulls the clamping sheet 220 to be bundled. The clamping sheet driving member 310 is a line, wire or rod made of flexible material. The proximal end of the clamping sheet driving member 310 is connected to the clamping handle mechanism 3, and the distal end extends from the distal end of the catheter 2 after passing through the interior of the catheter 2 and is connected to the free end of the clamping sheet 220. Each of the clamping sheet driving members 310 is respectively connected to one of the clamping sheets 220, so that the clamping sheet 220 can be pulled to clamp and contract by pulling the clamping sheet driving member 310, and the clamping sheet 220 can be freely unfolded by releasing the clamping sheet driving member 310. Therefore, when clamping the leaflet, the clamping arm 210 needs to be unfolded. Since the clamping piece 220 itself is elastic and will unfold automatically, the clamping piece 220 needs to be pulled toward the center by the clamping piece driving member 310 before clamping, so that the leaflet can freely extend into the valve accommodating space between the clamping piece 220 and the inner clamping arm 211.

[0072] like Figure 10-18As shown, the locking assembly 40 is fixedly connected to the connecting assembly 10, and the locking assembly 40 locks the up and down movement of the driving rod 320, thereby locking the clamping arm 210. The locking assembly 40 includes a lock seat 41, a lock member 42, an elastic member 43, an unlocking member 44, and an unlocking control member 45. The lock member 42 and the elastic member 43 are both arranged in the lock seat 41. The lock seat 41 is fixedly connected to the second connecting member 120 in the connecting assembly 10, and the connection method is not limited to: welding, riveting, threaded connection, bonding, and laser welding is preferred here; the driving rod 320 of the clamping arm driving member passes through the lock seat 41, the lock member 42 and the elastic member 43, and the lock member 42 and the elastic member 43 are limited by the driving rod 320 of the clamping arm driving member and the lock seat 41 and do not disengage; The elastic member 43 pushes the locking member 42 to clamp the driving rod 320 of the clamp arm driving member, and the driving rod 320 of the clamp arm driving member is locked and cannot move up and down; the unlocking member 44 slides with the lock seat 41 and pushes the locking member 42 and the elastic member 43 to move, the elastic member 43 is deformed, and the locking member 42 releases the clamping of the driving rod 320 of the clamp arm driving member; the unlocking control member 45 is installed in the catheter 2, and its proximal end is connected to the clamping handle mechanism 3 and the distal end is connected to the unlocking member 44. Pulling the unlocking control member 45 drives the unlocking member 44 to move upward and unlock.

[0073] Specifically, the lock base 41 is a frame structure, wherein the lock member 42 and the elastic member 43 are arranged in the lock base 41, and the driving rod 320 that passes through the lock base 41 also passes through the lock member 42, and preferably the elastic member 43 is also passed through the driving rod 320. The lock member 42 is provided with a locking hole, and the aperture of the locking hole is larger than the diameter of the driving rod 320. When the lock member 42 is tilted, the hole wall of the locking hole abuts against the driving rod 320, locking it so that it cannot move up and down. When the lock member 42 is horizontal, the driving rod 320 can move up and down freely due to the large aperture of the locking hole. The unlocking member 44 is used to change the tilted state of the lock member 42 to the horizontal state, and the unlocking member 44 can be connected or abutted with the end of the lock member 42 that tilts downward, and pull the lock member 42 to form a horizontal state, thereby completing the unlocking.

[0074] like Figure 10-12As shown, as the first preferred embodiment of the present invention, the lock seat 41 is a square frame with a through hole in the middle, and a block 411 protruding inward is provided on one side of the inner side wall of the lock seat 41; the lock member 42 is a sheet, and one end of the lock member 42 is stuck above the block 411; the elastic member 43 is arranged above the lock member 42; in the locked state, the elastic member 43 pushes the end of the lock member 42 away from the block 411 to move downward, so that the lock member 42 remains in an inclined state and thus locks the drive rod 320; the opening and closing angle of the clamp arm 210 is locked by locking the drive rod 320. Among them, the lock member material is a hard alloy with biocompatibility, such as a cobalt-based alloy or a titanium alloy, and preferably a cobalt-chromium alloy, and the elastic member material is an elastic material with biocompatibility suitable for implantation, such as a nickel-titanium alloy or 316L stainless steel, and preferably a nickel-titanium alloy.

[0075] The unlocking member 44 is a closed-loop metal wire passing through the lock seat 41. One end of the unlocking member 44 is restricted below the block 411, and the other end is located below the side of the lock member 42 away from the block 411. When the unlocking member 44 is pulled upward by the unlocking control member 45, the end of the unlocking member 44 restricted by the block 411 does not move, and the other end of the unlocking member 44 pulls the lock member 42 and the elastic member 43 to move upward, so that the lock member 42 gradually tends to a horizontal state, thereby releasing the lock on the driving rod 320. When the lock member 42 is in an inclined state, the lock member 42 will clamp the two sides of the driving rod 320, thereby clamping the driving rod 320. When the lock member 42 is in a horizontal state, the through hole with a larger aperture in the lock member 42 cannot restrict the driving rod 320, thereby achieving unlocking.

[0076] In addition to the above embodiments, the locking assembly 40 may also be of the following structure:

[0077] The second implementation method: refer to Figure 13-15 The lock seat 41 is a square frame with a through middle, and a lock hinge support 412 extending inward is provided on one side of the lock seat 41; the lock 42 is a sheet, and the middle part of the lock 42 is hinged to the lock hinge support 412; the elastic member 43 is provided on the upper side of the lock 42; in the locked state, the elastic member 43 pushes one end of the lock 42 to move downward, so that the lock 42 maintains an inclined state and thus locks the driving rod 320; specifically, the lock hinge support 412 is located on one side of the driving rod 320, and only one side of the lock 42 is connected to the lock hinge support 412 through a hinge;

[0078] The unlocking member 44 is a closed-loop metal wire passing through the lock seat 41, one end of the unlocking member 44 is restricted below the lock hinge support 412, and the other end is located below the side of the lock 42 away from the lock hinge support 412. Then, when the unlocking member 44 is pulled upward by the unlocking control member 45, the unlocking member 44 will pull the lock 42 and one end of the elastic member 43 to move upward, so that the lock 42 tends to a horizontal state, thereby releasing the lock on the drive rod 320.

[0079] The third implementation method: Figure 16-18 The lock seat 41 is a square frame with a through middle; the lock member 42 includes two columns, which are respectively arranged on both sides of the driving rod 320, and the elastic member 43 is arranged above the two columns; in the locked state (the elastic member is in a free state), the elastic member 43 pushes the two columns to move closer to the center, so that the two columns clamp and lock the driving rod 320;

[0080] The unlocking member 44 is a closed-loop metal wire passing through the lock seat 41, and the two ends of the unlocking member 44 are respectively restricted under the two columnar bodies. Then, when the unlocking member 44 is pulled upward by the unlocking control member 45, the two columnar bodies move upward and separate from each other at the same time, thereby releasing the lock on the driving rod 320.

[0081] The unlocking control member 45 is a member for controlling the action of the unlocking member 44. When in the locked state, the unlocking control member 45 drives the unlocking member 44 to move and release the lock. The unlocking control member 45 is a wire, thread or rod made of a flexible material. The unlocking control member 45 is installed in the catheter 2, and the proximal end is connected to the clamping handle mechanism 3, and the distal end is connected to the unlocking member 44. The clamping handle mechanism 3 is operated to pull the unlocking control member 45 to pull the unlocking member 44 to release the lock of the locking member 42. Under the action of the elastic member 43, the locking member 42 releases the clamping lock of the driving rod 320.

[0082] like Figure 19-22 As shown, the connection assembly 10 is used to connect the clamp assembly 10 with the control rod 4 and the catheter 2. The connection assembly 10 includes a first connection member 110 fixedly connected to the distal end of the catheter 2 and a second connection member 120 fixed to the locking assembly 40. The first connection member 110 and the second connection member 120 are connected together by buckling or concave-convex matching. Fig.19 As shown, the first connecting member 110 and the second connecting member 120 are buckled together, which means that a lock buckle 121 and a lock head 111 are respectively provided at the ends of the two members, and the two members are plugged and fixedly connected together. Figure 20-21As shown, the concave-convex fit is that the two are respectively provided with a groove 114 and a boss 113, and the two are matched and connected to form a whole. The concave-convex fit requires a connecting sleeve 130 to limit the two so that they do not separate. The connecting sleeve 130 of the present invention can be a limiting cylinder sleeved on the outside of the two, or a limiting piece on both sides of the two. The connecting sleeve 130 is set on the distal end of the catheter 2 or the connecting component, and its movement is controlled by a guide wire or other connecting components set in the catheter.

[0083] The first connecting member 110 and the second connecting member 120 are tubular structures, and the concave and convex structures are respectively arranged at the ends of the tubular structures; the distal end of the control rod 4 is directly and detachably fixedly connected to the clamping assembly 20, or is detachably connected to the clamping assembly 20 through the sliding rod 150. Specifically, the distal end of the control rod 4 is directly and detachably fixedly connected to the driving rod 320 in the clamping assembly 20, or is detachably connected through the sliding rod 150.

[0084] The first connector 110 is fixed to the end of the catheter 2, and its center coincides with the center of the catheter 2. The control rod 4 is set at the center of the catheter 2. The control rod 4, the guide wire and other structures set in the catheter 2 can pass through the first connector 110. There are many ways to fix the first connector 110 and the catheter 2, one is an integrated structure of the two, and the second is that the two are fixedly connected together through a fixing head 201.

[0085] The control rod 4 has an internal thread or an external thread at its distal end, and the drive rod 320 has an external thread or an internal thread at its proximal end, and the two are threadedly connected. In other embodiments, the two can be connected in other detachable ways such as snap-on connection.

[0086] In addition, if Fig. 22 As shown, in other embodiments, the control rod 4 can be detachably fixedly connected to the driving rod 320 through the sliding rod 150. The sliding rod 150 is provided with an external thread, and the distal end of the control rod is provided with an internal thread, and the two are screwed and fixed.

[0087] In other embodiments, a connecting sleeve 130 is provided at the proximal end of the slide bar 150, and the inner diameter of the connecting sleeve 130 is larger than the outer diameter of the first connecting member 110 and the second connecting member 120, and the first connecting member 110 and the second connecting member 120 can be inserted therein to prevent the two from being separated, and the length of the connecting sleeve 130 satisfies that during the up and down movement driven by the control rod 4, the first connecting member 110 and the second connecting member 120 are always set and limited. The inner wall of the slide bar 150 at the distal end of the connecting sleeve 130 is provided with a thread, which is screwed to the control rod 4; in addition, the slide bar 150 and the control rod 4 can be connected by a snap-fit ​​connection.

[0088] like Figure 1As shown, the clamping handle mechanism 7 includes a housing 710 and a telescopic rotation adjustment knob 720. The telescopic rotation adjustment knob 720 is installed at the proximal end of the housing 710 and is respectively connected to the proximal end of the control rod 4 for controlling telescopic movement and rotation.

[0089] The clamping handle mechanism 7 includes a first pull rod 730 , and the first pull rod 730 is respectively connected to two clamping plate driving members 710 . The clamping plate driving members 310 can be pulled by pulling the first pull rod 730 .

[0090] The clamping handle mechanism 7 includes a second pull rod 740 , and the second pull rod 740 is connected to the unlocking control member 45 . The unlocking control member 45 can be pulled by pulling the second pull rod 740 .

[0091] like Figure 1 As shown, another important structure in the valve clamping system is: a clamping state monitoring device, which monitors the clamping position and clamping degree of the valve leaflets to see whether they are appropriate, so as to avoid stenosis caused by excessive clamping degree. On the contrary, if the clamping degree is too small, the clamping is insufficient and there is still the problem of regurgitation. In the mitral valve clamping technology, there is an indicator, namely, the transvalvular pressure difference, which can be used to determine whether the clamping position and degree of the mitral valve clamping device are appropriate. Then, the blood pressure collection mechanism 5 uses atrial blood pressure to determine whether the clamping position and clamping degree are appropriate. In clinical applications, when the transvalvular pressure (blood pressure near the mitral valve orifice) is about 4 mg / hg, the clamping is appropriate. When the transvalvular pressure is less than 4 mg / hg, it is determined that there is regurgitation, that is, the clamping is incomplete. The smaller the value, the smaller the clamping degree. On the contrary, when the transvalvular pressure is greater than 4 mg / hg, it is determined that stenosis, that is, excessive clamping, and the larger the value, the greater the clamping degree.

[0092] The structure and position of the blood pressure collection mechanism 5 can be implemented in a variety of ways:

[0093] The first implementation method is: Figure 23-24 As shown, the blood pressure collection mechanism 5 includes a pressure sensor 51 and a connecting tube 53 buried in the inner wall of the distal end of the catheter 2. The two ends of the connecting tube 53 are respectively connected to the pressure sensor 51 and the outside of the catheter 2 to measure the blood pressure outside the distal end of the catheter 2. A monitoring hole 202 is opened at the distal end of the catheter 2, and the distal end of the connecting tube 53 is connected through the monitoring hole 202. Here, the outside of the catheter refers to the atrial space of the heart. The communication connection between the pressure sensor 51 and the blood pressure analysis and judgment mechanism 6 can be wireless and wired. Among them, the wired method is: a connecting wire is buried in the inner wall of the catheter 2, and the distal end of the connecting wire is connected to the pressure sensor 51, and the proximal end of the connecting wire is connected to the blood pressure analysis and judgment mechanism 6. Or a monitoring channel 52 that passes through the pressure sensor 51 and the blood pressure analysis and judgment mechanism 6 is provided in the catheter 2, and the connecting wire is arranged in the monitoring channel 52. The wireless transmission method can adopt the existing technology, which will not be repeated here.

[0094] like Figure 25-26 The second embodiment is as follows: a monitoring channel 52 is provided in the catheter 2, and a blood pressure collection mechanism 5 is provided in the monitoring channel 52. The blood pressure collection mechanism 5 includes a monitoring protective sleeve 521 provided at the distal end of the monitoring channel 52, a pressure sensor 51 provided in the monitoring protective sleeve 521, and a connecting tube 53. The two ends of the connecting tube 53 are respectively connected to the pressure sensor 51 and the outside of the catheter 2 to measure the external blood pressure at the distal end of the catheter 2. The monitoring channel 52 can pass through the distal end and the proximal end of the catheter 2, or only the monitoring channel 52 can be provided at the distal end of the catheter 2 for placing the pressure sensor 51 and the connecting tube 53. The monitoring channel 52 closes the pressure sensor 51 and is only connected to the atrium through the connecting tube 53. This solution can be connected to the blood pressure analysis and judgment mechanism 6 by wireless transmission.

[0095] like Fig.26 As shown, the pressure sensor includes a housing 522 and an upper cover 526 snapped with the housing 522 . A PCB board 523 is arranged in the housing 522 . The PCB board 523 is provided with a sensing module 525 . The housing 522 is provided with a connecting hole 524 connected to the connecting pipe 53 .

[0096] like Fig. 27 As shown, the third embodiment of the blood pressure collection mechanism is: the blood pressure collection mechanism 5 includes a pressure sensor 51, and the guide wire 8 passes through the guide wire hole 205 at the distal end of the catheter 2 through the guide wire channel 203, and the pressure sensor 51 is fixedly connected to the passing part of the guide wire 8. In this method, the pressure sensor 51 is directly located in the atrium to directly measure the blood pressure. The pressure sensor 51 is covered with a protective cover, leaving only the collection hole to prevent the blood pressure from entering other parts of the pressure sensor 51. It is preferred that wireless transmission is used in this method.

[0097] Implementation process: refer to Figure 28-31 ,exist Fig.28 In order to reach the initial position of the atrium, the valve clipping system is pushed out of the delivery device. Fig.29 In the process, the valve clamping system is transported through the left atrium LA and vertically delivered to the middle position of the mitral valve MV by the transport device. At this time, the control rod 4 is manipulated to control the expansion angle of the clamping piece 220 and the clamping arm 210 so that the leaflets extend into the valve accommodating space. The leaflets are clamped by the clamping piece 220 and the clamping arm 210, and the opening and closing angle of the clamping arm 210 is adjusted to make the mitral valve reach the optimal closed state.

[0098] When the valve clip system needs to be removed, refer to Fig.30, the lower hinge support 240 is pushed downward by the driving rod 320, so that the clamp arm 210 is turned over, and the inner clamp arm and the outer clamp arm are contracted into a bundle along the length (the inner clamp arm and the outer clamp arm are contracted together separately). At this time, the width of the entire valve clamping device reaches the minimum value, and there is no angle between the clamp arm 210 and the leaflet and the tendon cord, so that it can easily get rid of the tendon cord plexus. Fig.31 As shown, the valve clipping system is recovered by a delivery device and pulled upward freely, thereby achieving the retrievability of the valve clipping device.

Claims

1. A valve clamping system, characterized in that: It comprises a valve clamping device and a clamping state monitoring device, wherein the valve clamping device comprises a catheter, a valve clamping mechanism arranged at the distal end of the catheter, and a clamping handle mechanism arranged at the proximal end of the catheter; a control rod is inserted into the catheter, the distal end of the control rod is detachably connected to the valve clamping mechanism, and the proximal end is connected to the clamping handle mechanism, and the control rod is operated by the clamping handle mechanism to drive the valve clamping mechanism to achieve valve clamping; The clamping state monitoring device at least includes a blood pressure collection mechanism provided on the valve clamping mechanism or at the distal end of the catheter, and a blood pressure analysis and judgment mechanism for analyzing the blood pressure information collected by the blood pressure collection mechanism; The valve clamping mechanism comprises a connecting assembly for detachably connecting with the control rod and the distal end of the catheter, a clamping assembly for clamping the valve leaflet, a driving assembly for driving the clamping assembly to open and close, and a locking assembly for locking the action of the driving assembly; The clamping assembly comprises a clamping arm and a clamping sheet for clamping the valve leaflet; The locking assembly is fixedly connected to the connecting assembly; The driving assembly comprises a clamp arm driving member connected to the control rod and a clamp sheet driving member inserted into the catheter, wherein the clamp arm is unfolded by the clamp arm driving member and is attached to the clamp sheet to clamp the leaflet, and is turned over and gathered into a bundle by the clamp arm driving member; the clamp sheet driving member gathers the freely unfolded clamp sheet toward the center into a bundle; The clamping arm comprises an inner clamping arm that cooperates with the clamping sheet for clamping and an outer clamping arm that supports the inner clamping arm; The clamping arms include at least one group of outer clamping arms and at least one group of inner clamping arms, each group of the outer clamping arms includes two outer clamping arms symmetrically arranged on the left and right, and each group of the inner clamping arms includes two inner clamping arms symmetrically arranged on the left and right; The inner clamp arm and the outer clamp arm are at least partially rigid structures, the inner end of each inner clamp arm is rotatably connected to the upper hinge support, the inner end of each outer clamp arm is rotatably connected to the lower hinge support, and the outer ends of the inner clamp arm and the outer clamp arm on the same side are rotatably connected; Alternatively, the inner clamp arm and / or the outer clamp arm are made of elastic material, the inner end of each inner clamp arm is fixedly connected to the upper hinge support, the inner end of each outer clamp arm is fixedly connected to the lower hinge support, and the outer ends of the inner clamp arm and the outer clamp arm on the same side are fixedly connected or an integral structure.

2. The valve clamping system according to claim 1, characterized in that: The blood pressure collection mechanism includes a pressure sensor and a connecting tube buried in the inner wall of the distal end of the catheter. The two ends of the connecting tube are respectively connected to the pressure sensor and the outside of the catheter to measure the blood pressure outside the distal end of the catheter.

3. The valve clamping system according to claim 1, characterized in that: A monitoring channel is provided in the catheter, and the blood pressure collection mechanism includes a monitoring shell arranged at the far end of the monitoring channel, a pressure sensor arranged in the monitoring shell, and a connecting tube. The two ends of the connecting tube are respectively connected to the pressure sensor and the outside of the catheter to measure the blood pressure outside the far end of the catheter.

4. The valve clamping system according to claim 1, characterized in that: The blood pressure collection mechanism comprises a pressure sensor, and the pressure sensor is fixedly connected to a guide wire passing through the distal end of the catheter.

5. The valve clamping system according to any one of claims 2 to 4, characterized in that: A connecting wire is buried in the inner wall of the conduit, or a connecting wire is passed through the conduit; The distal end of the connecting line is connected to the pressure sensor, and the proximal end of the connecting line is connected to the blood pressure analysis and judgment mechanism.

6. The valve clipping system according to claim 1, characterized in that: The clamping piece is elastically fixed on the connecting assembly; in a free state, the clamping piece stretches outwards and cooperates with the unfolded clamping arm to clamp the leaflet.

7. The valve clipping system according to claim 1, characterized in that: The clamp arm driving member is a driving rod, which passes through the connecting assembly, the upper hinge support and the lower hinge support, and drives the lower hinge support to move up and down to drive the clamp arm to be retracted or unfolded.

8. The valve clipping system according to claim 7, characterized in that: The locking assembly is fixedly connected to the connecting assembly, and the locking assembly locks the up and down movement of the driving rod, thereby locking the clamping arm.

9. The valve clipping system according to claim 1, characterized in that: The clamping piece driving member is installed in the catheter, and the distal end of the clamping piece driving member is connected to the free end of the clamping piece, and the proximal end is connected to the clamping handle mechanism. The clamping piece driving member pulls the clamping piece to be gathered into a bundle.

10. The valve clipping system according to claim 9, characterized in that: The clamping piece driving member is a wire, a thread or a rod made of a flexible material.

11. The valve clipping system according to claim 1, characterized in that: The locking assembly includes a lock seat, a lock element, an elastic element, an unlocking element, and an unlocking control element; The locking member and the elastic member are both arranged in the locking seat, the locking seat is fixedly connected to the connecting assembly, the clamp arm driving member passes through the locking seat, the locking member and the elastic member, and the locking member and the elastic member are limited by the clamp arm driving member and the locking seat; The elastic member pushes the locking member to clamp the clamp arm driving member, and the clamp arm driving member is locked; The unlocking member is slidably matched with the lock seat, and pushes the locking member and the elastic member to move, the elastic member is deformed, and the locking member releases the clamping of the clamp arm driving member; The unlocking control member is installed in the catheter, with its proximal end connected to the clamping handle mechanism and its distal end connected to the unlocking member. The unlocking control member controls the unlocking member to release the clamping of the clamp arm driving member.

12. The valve clipping system according to claim 11, characterized in that: The unlocking control member is a wire, a thread or a rod made of a flexible material.

13. The valve clipping system according to claim 1, characterized in that: The connecting assembly comprises a first connecting piece fixedly connected to the distal end of the catheter and a second connecting piece fixed on the locking assembly. The first connecting piece and the second connecting piece are connected together by snapping or concave-convex fitting.

14. The valve clipping system according to claim 13, characterized in that: The first connecting member and the second connecting member are tubular structures; the far end of the control rod is directly detachably fixedly connected to the clamping assembly, or is detachably connected to the clamping assembly via a sliding rod.

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