WO2024032743A1

WO2024032743A1 - Valve clamping system

Info

Publication number: WO2024032743A1
Application number: PCT/CN2023/112379
Authority: WO
Inventors: 张庭超; 王泽涛; 江巍; 张伟伟
Original assignee: 杭州德晋医疗科技有限公司
Priority date: 2022-08-11
Filing date: 2023-08-10
Publication date: 2024-02-15

Abstract

A valve clamping system (1), comprising a conveying apparatus (40) and a valve clamp (20). The conveying apparatus (40) is used for conveying the valve clamp (20). The conveying apparatus comprises a conveying rod and a flexible connection member (43). The conveying rod is detachably connected to the valve clamp (20); the flexible connection member (43) has a relaxed state and a tensioned state. When a reflux assessment is performed after a valve is clamped with the valve clamp (20), the flexible connection member (43) is configured to be in the relaxed state to interrupt the continuity of the structure and force between the valve clamp (20) and the conveying rod of the conveying apparatus (40).

Description

Valve clamping system

This application requests the priority of the Chinese patent application submitted to the China Patent Office on August 11, 2022, with the application number 2022109597756 and the application name "Delivery Device and Valve Clamping System". It also requires that it be submitted to the Chinese Patent Office on August 11, 2022. The Chinese Patent Office has the right of priority to the Chinese patent application with application number 2022109624429 and the application title "Valve Clamping System", the entire content of which is incorporated into this application by reference.

Technical field

The present application relates to the technical field of medical devices, and in particular to a valve clamping system.

Background technique

The mitral valve is a one-way valve located between the left atrium (labeled LA in Figures 1 to 4) and the left ventricle (labeled LV in Figures 1 to 4) of the heart. A normal and healthy mitral valve It controls the flow of blood from the left atrium to the left ventricle while preventing blood from flowing from the left ventricle to the left atrium. The mitral valve consists of a pair of leaflets, called the anterior leaflet and the posterior leaflet. When the edges of the anterior leaflet and the posterior leaflet meet, the mitral valve can be completely closed to prevent blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or its related structures undergo organic or functional changes, the anterior and posterior leaflets of the mitral valve are poorly aligned. As a result, when the left ventricle of the heart contracts, the mitral valve cannot fully The valve closes, causing blood to flow back from the left ventricle to the left atrium, causing a series of pathophysiological changes called "mitral regurgitation."

Surgery usually uses surgical methods such as edge-to-edge suturing to treat mitral valve regurgitation. However, this type of surgery has shortcomings such as complicated surgical procedures, high surgical costs, high patient trauma, high risk of complications, long hospital stays, and painful recovery processes for patients.

Referring to Figures 1 to 4, there is an existing minimally invasive treatment device, which is based on the principle of edge-to-edge surgery of the valve. The valve clamp 12 is delivered to the mitral valve in an interventional manner through the delivery device 11, and then through the valve clamp 12 The anterior and posterior leaflets of the mitral valve are held in relative opening and closing to achieve the purpose of fixing the leaflets and reducing mitral valve regurgitation. In actual use, it is usually necessary to observe and evaluate the state of mitral regurgitation after the valve leaflets are clamped by the valve clamp 12, and only after confirming that the state of mitral regurgitation has improved to the desired effect can the delivery device 11 be connected to the available valve leaflets. The valve clamp 12 connected to the distal end of the delivery device 11 is detached. Since there is structural and force coherence between the valve clamp 12 and the delivery instrument 11 during the evaluation, the movement of the valve clamp 12 will be affected by the delivery instrument 11 , thereby affecting the opening and closing activity of the two mitral valve leaflets held by the valve clamp 12 will be restricted; but after the valve clamp 12 is separated from the delivery device 11, the structural and force connection between the valve clamp 12 and the delivery device 11 is released, and the valve clamp 12 is also removed from the pull of the delivery device 11, then the valve clamp 12 clamp The degree of opening and closing activity of the two held mitral valve leaflets will increase. This will cause a big difference between the regurgitation situation when the valve clamp 12 is not separated from the delivery device 11 and the reflux situation after the valve clamp 12 is separated from the delivery device 11; even the regurgitation is improved during the evaluation, but the valve clamp 12 A situation in which mitral regurgitation worsens after separation from the delivery device 11. At the same time, in the prior art, once the valve clamp 12 is separated from the delivery instrument 11, it cannot be reconnected to the delivery instrument 11, that is, the valve clamp 12 cannot be adjusted again by manipulating the delivery instrument 11. If the separated valve clamp 12 has an unsatisfactory improvement effect on regurgitation, the surgical effect will be unsatisfactory or even fail.

Contents of the invention

The purpose of this application is to provide a valve clamping system. The valve clamping system can evaluate the improvement effect of the valve clamp on atrioventricular valve regurgitation in a state where the delivery device and the valve clamp are nearly separated, and can also be used in situations where the regurgitation improvement effect is not ideal. Next, the valve clamp is adjusted and controlled again.

In order to achieve the above object, this application provides a valve clamping system, which includes a delivery device and a valve clamper, and the delivery device is used to transport the valve clamper;

Wherein, the delivery device includes a delivery rod and a soft connector, and the delivery rod is detachably connected to the valve clamp;

The soft connector has a relaxed state and a tensioned state; when the valve clamp clamps the valve for regurgitation assessment, the soft connector is configured to be in the relaxed state to interrupt the valve clamp. The structural and force coherence between the coupling and the conveying rod of the conveying device.

In one embodiment, the conveying rod includes a first conveying rod and a second conveying rod;

The distal end of the first delivery rod is provided with a first docking portion;

The distal end of the second delivery rod is detachably connected to the valve clamp, and the proximal end of the second delivery rod is provided with a second docking portion, and the second docking portion is used to cooperate with the first docking portion. , so that the second conveying rod can be detachably connected to the first conveying rod; the distal end of the soft connecting piece is connected to the second conveying rod, and the soft connecting piece is at least partially movably threaded through the first conveying rod. Inside a conveyor rod;

Wherein, in the relaxed state of the soft connector, the first butt joint part and the second butt joint part can be disengaged, so that the first conveyor rod and the second conveyor rod can be separated; in In the tensioned state, the first conveying rod can move along the soft connector until the first docking part and the second docking part cooperate, so that the first conveying rod connects to the second docking part. Conveyor rod.

In one embodiment, the delivery rod is an integral structure and has a first docking portion at its distal end; the valve clamp includes a connecting rod, and a second docking portion is provided at the proximal end of the connecting rod. Two butt parts are used to cooperate with the first butt part so that the connecting rod can be detachably connected to the conveying rod;

Wherein, the distal end of the soft connector is connected to the connecting rod, and at least part of the soft connector is movably inserted into the delivery rod; in the relaxed state of the soft connector, the third The mating portion and the second mating portion can be disengaged to separate the conveying rod from the connecting rod; in the tensioned state, the conveying rod can move along the soft connector to the The first butt portion cooperates with the second butt portion so that the conveying rod is connected to the connecting rod.

The valve clamping system provided by the present application is provided with the soft connector that can be loosened and tightened. When the valve clamp clamps the valve for regurgitation assessment, the soft connector can be in a relaxed state to allow the first docking part and the second docking part to loosen and separate from each other. At this time, the valve clamp is close to final release (i.e., the delivery device and the valve clamp The state in which the valve clamp is completely separated) is equivalent to interrupting the structural and force connection between the valve clamp and the delivery device (specifically, the delivery rod of the delivery device). The movement of the held valve is basically not constrained by the delivery device, which is conducive to a more accurate assessment of the reflux improvement effect; if the reflux improvement effect is evaluated to be unsatisfactory, the soft connector can be re-tensioned state, the delivery rod provided with the first docking part can move under the guidance of the soft connector to make the first docking part and the second docking part cooperate, thereby allowing the delivery device to connect again. The valve clamping device allows subsequent adjustment and control of the valve clamping device, which is beneficial to improving the regurgitation improvement effect.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required to be used in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present application. For ordinary people in the art For technical personnel, other drawings can also be obtained based on these drawings without exerting creative work.

1 to 4 are schematic diagrams of the use process of a valve clamping system in the prior art.

Figure 5 is a schematic three-dimensional structural diagram of the valve clamping system provided by the first embodiment of the present application.

Figure 6 is a partial cross-sectional view of the valve clamping system shown in Figure 5.

7 is a schematic three-dimensional structural diagram of the conveying device in the first embodiment of the present application when the first conveying rod and the second conveying rod are connected.

FIG. 8 is a schematic three-dimensional structural diagram of the conveying device shown in FIG. 7 when the first conveying rod and the second conveying rod are separated.

FIG. 9 is a schematic three-dimensional structural view of the first docking portion of the first conveying rod shown in FIG. 8 .

FIG. 10 is a schematic three-dimensional structural view of the second docking portion of the second conveying rod shown in FIG. 8 .

FIG. 11 is a cross-sectional view along the XI-XI direction shown in FIG. 6 .

Figure 12 is a schematic diagram of the connection between the first conveying rod and the soft connector in another embodiment.

FIG. 13 is a cross-sectional view along the XIII-XIII direction shown in FIG. 12 .

FIG. 14 is a cross-sectional view along the XIV-XIV direction shown in FIG. 12 .

Figure 15 is a partial structural schematic diagram of the first conveying rod, the second conveying rod and the soft connector in another embodiment.

FIG. 16 is a cross-sectional view along the XVI-XVI direction shown in FIG. 15 .

Figure 17 is a partial structural schematic diagram of the first conveying rod, the second conveying rod and the soft connector in yet another embodiment.

FIG. 18 is a cross-sectional view along the XVIII-XVIII direction shown in FIG. 17 .

Figure 19 is a schematic connection diagram of the control part and the soft connection part of the conveying device in one embodiment.

Figure 20 is a schematic diagram of the connection between the control part and the soft connection part of the conveying device in another embodiment.

21 to 24 are schematic diagrams of the use process of the valve clamping system provided by the first embodiment.

Figure 25 is a schematic three-dimensional structural diagram of the valve clamping system provided by the second embodiment of the present application when the first delivery rod and the second delivery rod are separated.

Figure 26 is a cross-sectional view along the XXVI-XXVI direction shown in Figure 25.

Figure 27 is a partial cross-sectional view of the first conveying rod, the second conveying rod and the soft connector in another embodiment.

28 to 31 are schematic diagrams of the use process of the valve clamping system provided in the second embodiment.

Figure 32 is a partial three-dimensional structural diagram of the delivery device of the valve clamping system provided by the third embodiment of the present application when the first delivery rod and the second delivery rod are separated.

Figure 33 is a partial cross-sectional view of the conveying device shown in Figure 32 when the first conveying rod and the second conveying rod are connected.

FIG. 34 is a partial cross-sectional view of the delivery device shown in FIG. 33 when the first delivery rod and the second delivery rod are separated after the first delivery rod moves toward the proximal end.

Figure 35 is a schematic three-dimensional structural diagram of the valve clamping system provided by the fourth embodiment of the present application when the delivery rod and the connecting rod are connected.

Figure 36 is a schematic three-dimensional structural diagram of the valve clamping system shown in Figure 35 when the delivery rod and connecting rod are separated.

Figure 37 is a partial cross-sectional view of the valve clamping system shown in Figure 35.

Fig. 38 is a schematic three-dimensional structural view of the second butt portion of the connecting rod shown in Fig. 36.

39 to 42 are schematic diagrams of the use process of the valve clamping system provided by the fourth embodiment.

Figure 43 is a schematic three-dimensional structural diagram of the valve clamping system provided by the fifth embodiment of the present application when the delivery rod and the connecting rod are separated.

Figure 44 is a partial cross-sectional view of the conveying rod, connecting rod and soft connector in another embodiment.

45 to 48 are schematic diagrams of the use process of the valve clamping system provided in the fifth embodiment.

Figure 49 is a partial three-dimensional structural diagram of the valve clamping system provided by the sixth embodiment of the present application when the delivery rod and the connecting rod are separated.

Fig. 50 is a partial cross-sectional view of the conveying rod and the connecting rod shown in Fig. 49 when they are connected.

FIG. 51 is a partial cross-sectional view of the delivery rod and the connecting rod separated after the delivery rod moved toward the proximal end in FIG. 50 .

Figure 52 is a partial cross-sectional view of the soft connector and the connecting rod in Figure 51 when they are disconnected.

The following specific embodiments will further describe the present application in conjunction with the above-mentioned drawings.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without any creative work fall within the scope of protection of this application.

In addition, the following description of the embodiments refers to the accompanying figures to illustrate specific embodiments in which the present application may be implemented. The directional terms mentioned in this application, such as "up", "down", "front", "back", "left", "right", "inside", "outside", "side", etc., are only Reference is made to the direction of the attached figures. Therefore, the directional terms used are for the purpose of better and clearer description and understanding of the present application, but are not intended to indicate or imply that the device or component referred to must have a specific orientation or be in a specific orientation. construction and operation, and therefore should not be construed as limitations on this application.

It should be noted that in order to more clearly describe the structure of the delivery device and valve clamping system provided by this application, this The limited terms "proximal" and "distal" mentioned in the specification of the application are commonly used terms in the field of interventional medicine. Specifically, the "distal end" refers to the end far away from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation; the direction of the central axis of rotation of objects such as cylinders and tubes is It is defined as the axial direction; the circumferential direction is the direction around the axis of objects such as cylinders and tubes (perpendicular to the axis and perpendicular to the section radius); the radial direction is the direction along the diameter or radius. It is worth noting that regardless of "near end", "far end", "one end", "other end", "first end", "second end", "initial end", "end", "both ends" , "end" appearing in words such as "free end", "upper end" and "lower end" is not limited to the end, endpoint or end face, but also includes from the end, endpoint, or end face at the end, endpoint, or The part of the element to which the end surface belongs extends an axial distance and/or a radial distance. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by a person skilled in the technical field belonging to this application. The conventional terms used in the specification of this application are only for the purpose of describing specific embodiments and shall not be construed as limitations of this application.

Please refer to Figure 5 and Figure 6 together. The present application provides a valve clamping system 1 for edge-to-edge clamping of valves, especially atrioventricular valves of the heart (not limited to mitral valves and tricuspid valves). Repair to treat regurgitation (not limited to mitral regurgitation, tricuspid regurgitation). The valve clipping system 1 includes a valve clipper 20 and a delivery device 40 . The valve clamper 20 is detachably connected to the distal end of the delivery device 40 for clamping at least two valve leaflets to perform edge-to-edge repair of the valve, and is placed in the human body after the edge-to-edge repair of the valve is completed. The delivery device 40 is used to deliver the valve clamp 20 .

As shown in Figures 5 and 6, in the first embodiment of the present application, the valve clamp 20 includes a base 23 and a pair of clamps 25. The pair of clamps 25 is preferably about the axis of the base 23. Symmetrical setup. Among them, a pair of clamps 25 is used to clamp a pair of valve leaflets (such as the anterior leaflet and the posterior leaflet of the mitral valve, or any two valve leaflets among the anterior leaflet, septal leaflet and posterior leaflet of the tricuspid valve), and The pair of valve leaflets can be pulled together to achieve edge-to-edge repair of the valve; the base 23 is used to detachably connect the distal end of the delivery device 40 to achieve detachable connection between the valve clamp 20 and the delivery device 40 . In this embodiment, each clamp 25 includes a first clamp and a corresponding second clamp. The second clamp is located on the side of the first clamp close to the axis of the valve clamp 20. The first clamp The distal end of the clip is rotatably connected to the base 23, and the distal end of the second clip is fixedly connected to the base 23. The first clip can rotate to approach or move away from the second clip, thereby realizing the capture and clamping of the leaflets. Hold or release. In other embodiments, the proximal end of the base 23 may be provided with a connecting rod for detachably connecting to the delivery device 40, and each clamp 25 may also only include a first clip whose distal end is rotatably connected to the base 23. A clip can be opened and closed relative to the connecting rod to capture, clamp or release the leaflets.

It should be noted that in the examples of Figures 5 and 6, the valve clamp 20 also includes a driving mechanism (not shown in the figure) and a self-locking mechanism (not shown in the figure) provided on the base 23. The driving mechanism It is used to drive the first clamping piece of each clamp 25 to rotate to capture, clamp or release the valve leaflets. The self-locking mechanism is used to enable the valve clamp 20 to complete the edge-to-edge repair of the valve. Self-locking. Of course, as needed, the self-locking mechanism can also be controlled to switch the valve clamp 20 from the self-locking state to the unlocking state, and then capture and clamp the valve leaflets again. Among them, it should be noted that the driving mechanism and the self-locking mechanism of the valve clamp 20 need to be connected to the valve clamp 20 before the delivery device 40 can correspondingly control the valve clamp 20 to operate. The driving mechanism and the self-locking mechanism The mechanism is similar to the driving mechanism and self-locking structure of the existing valve clamp, and the specific structure and working principle will not be described again here.

It can be understood that in other embodiments, the valve clamp 20 may also include more than two clamps 25 to clamp more than two valve leaflets, as long as it is ensured that the valve clamp 20 can clamp Alternatively, the valve leaflets can be loosened, self-locked or unlocked, which will not be described in detail.

Please refer to FIG. 7 and FIG. 8 together. In this embodiment, the conveying device 40 includes a first conveying rod 41 , a second conveying rod 42 and a soft connection 43 .

As shown in FIGS. 7 and 8 , the distal end of the first delivery rod 41 is provided with a first docking portion 411 , and the proximal end of the second delivery rod 42 is provided with a second docking portion 422 . The second docking portion 422 is used to cooperate with the second delivery rod 42 . The butt portion 411 allows the second conveying rod 42 to be detachably connected to the first conveying rod 41 . Optionally, the first docking part 411 and the second docking part 422 may adopt one of a threaded structure, a mortise-and-tenon structure, or a buckle structure. The two can cooperate with each other to realize the first conveying rod 41 and the second connecting part. The connection or disconnection of the conveyor rod 42. Specifically, please refer to Figures 7 to 10. In the first embodiment of the present application, the first docking portion 411 is a tenon block (see Figure 9) protruding from the distal end of the first delivery rod 41, and the second docking portion 422 is a mortise opening at the proximal end of the second delivery rod 42 (see Figure 10); as shown in Figure 7, when the first delivery rod 41 moves axially toward the distal end to the mortise block at its distal end (i.e., the first When the butt portion 411) is inserted into the mortise at the proximal end of the second conveyor rod 42 (i.e., the second butt portion 422), the first conveyor rod 41 Connected to the second delivery rod 42; as shown in Figure 8, when the first delivery rod 41 moves toward the proximal end in the axial direction until the tenon block at its distal end is detached from the mortise at the proximal end of the second delivery rod 42, the The first conveying rod 41 and the second conveying rod 42 are separated.

In other embodiments, the first docking part 411 may be a mortise opened at the distal end of the first delivery rod 41, and accordingly, the second docking part 422 may be a tenon block protruding from the proximal end of the second delivery rod 42. The connection or separation of the first conveying rod 41 and the second conveying rod 42 can also be realized by the combination of the two, which will not be described again.

In other embodiments, the first docking part 411 and the second docking part 422 may be a combination of external threads and internal threads, which connect and disconnect the first conveying rod 41 and the second conveying rod 42 through threaded connection. The first conveying rod 41 and the second conveying rod 42 can be separated by threaded connection; the first docking part 411 and the second docking part 422 can also be a combination of a clamping block and a hook, and the first connecting part 411 and the second connecting part 422 are engaged together. The first conveyor rod 41 and the second conveyor rod 42 can be separated by connecting and releasing the engagement between the conveyor rod 41 and the second conveyor rod 42, which will not be described again.

Preferably, in order to improve the accuracy and efficiency when the separated first docking part 411 and the second docking part 422 are docked and matched, the first docking part 411 may be provided with a first guide structure, and the second docking part 422 may be provided with a first guide structure corresponding to the first guide structure. A guide structure is adapted to a second guide structure. The first guide structure and the second guide structure cooperate with each other to achieve a docking guide effect, thereby making the docking of the first docking part 411 and the second docking part 422 faster and more accurate. . For example, when the first butt portion 411 and the second butt portion 422 are respectively a tenon block and a mortise eye, the tenon block can be made into a frustum-shaped tenon block with an outer diameter gradually decreasing from the proximal end to the distal end. The mortise is correspondingly made into a tapered hole-shaped mortise with an inner diameter that gradually increases from the proximal end to the distal end. In this way, the first docking part 411 can be quickly plugged into the second docking part 422, which improves the accuracy and efficiency of docking. . Those skilled in the art can understand that when the butt joint between the first butt portion 411 and the second butt portion 422 adopts a structure other than the mortise and tenon structure, the first butt portion 411 and the second butt portion 422 can also be connected through a diameter. The gradual change in size achieves the effect of docking guidance, thereby improving the accuracy and efficiency of docking, which will not be described in detail.

Further, as shown in Figures 7 and 8, the distal end of the second delivery rod 42 is also provided with a valve clamp connection end 421. The valve clamp connection end 421 is used to detachably connect the valve clamp 20, specifically the detachable connection. The proximal end of the base 23 of the valve clamp 20 allows the delivery device 40 to be detachably connected to the valve clamp 20 . The proximal end of the base 23 is provided with a connecting end (not shown in the figure) for mating with the valve clamp connecting end 421. The coupling between the valve clamp connecting end 421 and the connecting end of the base 23 can also be, but is not limited to, threaded. structure or buckle structure, etc. In the first embodiment shown in Figures 7 and 8, the valve clamp connecting end 421 is a stud protruding from the distal end of the second delivery rod 42, and the connecting end of the base 23 is a stud located at the proximal end of the base 23. Screw holes (not shown in the figure) are threadedly connected to realize the detachable connection of the delivery device 40 to the valve clamp 20 .

It should be noted that in the embodiment of the present application, both the first conveying rod 41 and the second conveying rod 42 are rod bodies, and their cross-sectional shapes may be, but are not limited to, circular, elliptical, triangular or polygonal, preferably transverse. The cross-section shape is a circular rod body, and the outer peripheral surfaces of the first delivery rod 41 and the second delivery rod 42 are smooth, which facilitates transportation and will not damage human blood vessel tissue. Furthermore, in order to adapt to the peripheral blood vessels of the human body, the axial length of the first delivery rod 41 is preferably greater than 800 mm, and in order to avoid damage to the atrium, the axial length of the second delivery rod 42 is preferably less than 10 mm. In addition, in order to ensure the safety of implantation, the first delivery rod 41, the first docking part 411, the second delivery rod 42, the second docking part 422 and the valve clamp connection end 421 are all made of biocompatible metal materials or high-quality materials. Made of molecular materials. Metal materials include but are not limited to one of 304 stainless steel, 306 stainless steel, nickel titanium and other materials or a combination of multiple materials. Polymer materials include but are not limited to polyether block polyamide and thermoplastic polyurethane. , nylon and other materials or a combination of multiple materials. In a possible implementation, the first docking part 411, the second docking part 422 and the valve clamp connection end 421 can be made by one of injection molding, laser cutting and mechanical processing, and then welded, The corresponding delivery rod can be integrated with the corresponding delivery rod by suitable means such as bonding or melting; in another possible implementation, the first docking part 411 can be integrally formed with the first delivery rod 41, and the second docking part 422 and the valve clamp The connecting end 421 can also be integrally formed with the second conveying rod 42 . Preferably, in the embodiment of the present application, in order to make the first delivery rod 41 and the second delivery rod 42 have good biocompatibility and good elasticity to adapt to blood vessels, and for easy processing, the first delivery rod The rod 41 and the first docking part 411, the second delivery rod 42 and the second docking part 422 and the valve clamp connecting end 421 are all made of polyether block polyamide material and are injection molded in a corresponding mold at one time.

Please refer to Figures 7 and 8 again. In the embodiment of the present application, the distal end of the soft connector 43 is connected to the proximal end of the second delivery rod 42, and the soft connector 43 is at least partially movably threaded through the first delivery rod 41. . It should be noted that the soft connector 43 The proximal end extends to the outside of the human body along with the proximal end of the first delivery rod 41, so that the state of the soft connector 43 can be changed by pulling or loosening the proximal end of the soft connector 43. Specifically, the soft connector 43 has a relaxed state and a tensioned state. By pulling the proximal end of the soft connector 43, the soft connector 43 can be placed in a tensioned state, and by releasing the proximal end of the soft connector 43, The soft connector 43 in the tensioned state is switched to a relaxed state.

It can be understood that when the soft connector 43 is in a relaxed state, the first butt portion 411 and the second butt portion 422 are allowed to loosen and separate from each other, so that the first conveyor rod 41 and the second conveyor rod 42 are separated. At this time, only the second delivery rod 42 with a smaller axial length in the delivery device 40 is connected to the valve clamp 20 , and the valve clamp 20 is near final release (that is, the delivery device 40 is completely separated from the valve clamp 20 ). The state is equivalent to interrupting the structural and force connection between the valve clamp 20 and the delivery device 40. The movement of the leaflets clamped by the valve clamp 20 is basically not restricted by the delivery device 40, which is conducive to more Accurately assess reflux improvement effects. If it is evaluated that the effect of improving the reflux is not ideal, the proximal end of the soft connector 43 can be pulled to reset the partially movable soft connector 43 that penetrates the first delivery rod 41 to a tensioned state. The rod 41 can move under the guidance of the soft connector 43 to make the first docking part 411 and the second docking part 422 dock and fit, so that the first delivery rod 41 can be connected to the second delivery rod 42 again, thereby allowing the delivery device 40 to connect with the valve. The clamp 20 is connected again. At this time, the valve clamp 20 can be adjusted and controlled by controlling the self-locking mechanism and the driving mechanism of the valve clamp 20, so that the valve clamp 20 can be unlocked and captured and clamped again. Holding the valve leaflets helps improve the reflux improvement effect. Of course, if it is evaluated that the effect of improving reflux is ideal, the soft connector 43 is tightened so that the first delivery rod 41 and the second delivery rod 42 are connected again through the guidance of the soft connector 43, and then the second delivery rod 42 is controlled. And the entire delivery device 40 is disconnected from the valve clamp 20, so that the valve clamp 20 is finally released and placed in the human heart.

It should be noted that in the embodiment of the present application, the soft connector 43 should be larger than the preset length, so that the distance between the separated first delivery rod 41 and the second delivery rod 42 is large enough, so that the valve When the regurgitation improvement effect is evaluated after the valve leaflet is clamped by the clamper 20, the first delivery rod 41 will not hinder the movement of the second delivery rod 42 and its connected valve clamper 20 with the valve leaflet. Among them, those skilled in the art can understand that the corresponding preset length of the soft connector 43 is related to the use occasion of the valve clamp 20 . Specifically, when the valve clamp 20 is used to perform edge-to-edge repair of the mitral valve, the preset length is the axial length of the first delivery rod 41, the axial length of the second delivery rod 42 and the valve clamp. When the valve clamp 20 is used to perform edge-to-edge repair of the tricuspid valve, the preset length is the axial length of the first delivery rod 41 , the sum of the axial length of the second delivery rod 42 and the upper and lower diameters of the right atrium of the heart where the valve clamp 20 is to be implanted. In the embodiment of the present application, it is preferred that the length of the soft connector 43 is greater than 1000 mm.

It should also be noted that in the embodiment of the present application, the soft connector 43 should have good flexibility, which can weaken the relationship between the first conveying rod 41 and the second conveying rod 42 after being separated from the second conveying rod 42. The influence of the valve clamp 20 on the relative opening and closing movements and amplitudes of the at least two valve leaflets clamped by the valve clamp 20 can be reduced or even eliminated. Preferably, in the embodiment of the present application, the bending force required when the soft connector 43 is bent to 90 degrees or close to 90 degrees is less than 0.1N, and further preferably, the bending force is less than 0.05N. Wherein, close to 90 degrees refers to an angle slightly smaller or larger than 90 degrees, such as any angle between 60 degrees and 120 degrees. Furthermore, in the embodiment of the present application, the soft connector 43 should also have good tensile strength to avoid the failure of the first conveyor rod 41 and the second conveyor rod 42 to be docked again due to the breakage of the soft connector 43. Preferably The tensile strength of the soft connector 43 is greater than 50N, and further preferably, the tensile strength of the soft connector 43 is greater than 60N.

Among them, in order to ensure the safety of implantation, the soft connector 43 can be made of, but is not limited to, silk, nylon, polyethylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, stainless steel, nickel titanium, etc., which have better softness and better Made of one or more metal materials, polymer materials or composite materials with high tensile strength and good biocompatibility. Specifically, in the embodiment of the present application, the soft connector 43 is preferably made of expanded polytetrafluoroethylene compounded with barium sulfate with developing function.

Further preferably, in the embodiment of the present application, a development mark can be provided on the soft connector 43, so that the soft connector 43 has a developing effect, so that the position of the soft connector 43 can be easily observed during surgery, thereby improving surgical efficiency. The development mark may be made of X-ray opaque gold, tantalum, barium sulfate, etc. added to the material of the soft connector 43, or may be X-ray opaque gold, tantalum, barium sulfate, etc. The developing wire, developing piece or developing tube made of material is fixed on the soft connector 43 by adhesion, crimping, etc., which is not limited.

As mentioned above, in the embodiment of the present application, the soft connector 43 is at least partially movably inserted through the first conveying rod 41 , so that after the first conveying rod 41 and the second conveying rod 42 are separated, the first conveying rod 41 can be along the soft connector 43 that is, in the soft The connecting piece 43 moves under the guidance to be connected to the second conveying rod 42 again.

Specifically, please refer to Figures 6, 8 and 11 together. In one possible implementation, the first delivery rod 41 is provided with a lumen 412 extending in the axial direction and penetrating both ends of the first delivery rod 41. The cavity 412 is used to slide the soft connector 43 through. As shown in Figures 6 and 8, in this embodiment, the soft connector 43 has a linear structure, and its distal end passes through the distal end of the lumen 412 and is fixedly connected to the second delivery rod 42, while the proximal end of the soft connector 43 The end passes out of the proximal end of the lumen 412 for the operator to pull or loosen.

Please refer to FIGS. 12 to 14 together. In another possible implementation, the first delivery rod 41 may also be provided with a lumen 412 extending obliquely relative to its axial direction. The lumen 412 penetrates the first delivery rod 41 . The distal surface and peripheral wall, the lumen 412 are used to slide the soft connector 43 through. As shown in Figures 12 to 14, in this embodiment, the soft connector 43 is also a linear structure, and its distal end passes through the distal end of the lumen 412 and is fixedly connected to the second delivery rod 42. The proximal end of the soft connector 43 The end passes through the proximal end of the lumen 412 and extends along the outer peripheral wall of the first delivery rod 41 to outside the proximal end of the first delivery rod 41 for the operator to pull or loosen.

In the above embodiment, the distal end of the soft connector 43 can be fixedly connected to the proximal end of the second delivery rod 42 by at least one of hinged, welded, knotted, sutured, bonded or fixed means. This is not a limitation. In addition, in order to reduce the resistance of the soft connector 43 when moving in the lumen 412, the minimum inner diameter of the lumen 412 is preferably greater than the maximum outer diameter of the soft connector 43, and the inner wall of the lumen 412 should be smooth, so that the soft connector 43 can move smoothly within the lumen 412.

In the above embodiment, the number of soft connectors 43 may be one or more, and the first delivery rod 41 has a lumen 412 corresponding to each soft connector 43 . Preferably, in the embodiments shown in Figures 6, 8 and 11 to 18, the number of soft connectors 43 is multiple, the first delivery rod 41 is provided with multiple lumens 412, and the multiple tubes are The lumen 412 is symmetrically distributed with respect to the axis of the first delivery rod 41. In this way, the plurality of soft connectors 43 movable through the plurality of lumens 412 in one-to-one correspondence are also arranged with respect to the axis of the first delivery rod 41. Symmetrically distributed, the distal ends of the plurality of soft connectors 43 are symmetrically distributed with respect to the axis of the second delivery rod 42 . It can be understood that when the first conveying rod 41 moves along the plurality of symmetrically distributed soft connectors 43, the first conveying rod 41 is less likely to shake, which improves the smoothness of movement of the first conveying rod 41, and the first conveying rod 41 The first butt portion 411 at the distal end of the rod 41 is more easily aligned with the second butt portion 422 at the proximal end of the second delivery rod 42 . More preferably, in an embodiment shown in FIGS. 15 and 16 , the soft connectors 43 are provided in multiple pairs, and each pair of soft connectors 43 is symmetrically distributed about the axis of the first delivery rod 41 . This can further improve the smoothness of movement of the first conveying rod 41 . It should be noted that the plurality of lumens 412 distributed symmetrically about the axis of the first delivery rod 41 are preferably distributed on opposite sides of the first docking part 411 .

As shown in Figures 6, 8 and 11 to 16, in one embodiment of the present application, the soft connector 43 can be made of at least one flexible wire, and the flexible wire is a single strand or multiple strands. wire, correspondingly, the lumen 412 opened by the first delivery rod 41 is a circular lumen. As shown in FIGS. 17 and 18 , in another embodiment of the present application, the soft connector 43 can also be made of at least one flexible belt. The flexible belt is not limited to a woven mesh with a porous structure. Strip, the lumen 412 opened by the first delivery rod 41 is a flat lumen.

It can also be understood that in other embodiments of the present application, the first delivery rod 41 may not have a lumen, but a tube body extending along the axial direction of the first delivery rod 41 may be provided on its outer peripheral wall. The distal end is close to the distal end of the first delivery rod 41 and extends at least part of the length toward the proximal end. The lumen of the tube body is used to slide the soft connector 43 through; the soft connector 43 is a linear structure, and its distal end passes through The distal end of the tube body is fixedly connected to the second delivery rod 42, and the proximal end of the soft connector 43 passes through the proximal end of the tube body and extends along the outer peripheral wall of the first delivery rod 41 to the proximal end of the first delivery rod 41. outside for the operator to pull or loosen.

Further, please refer to FIGS. 19 and 20 . In the embodiment of the present application, in order to facilitate the operator to pull or loosen the proximal end of the soft connector 43 , the delivery device 40 also includes a control member 44 . The proximal end is connected to a control part 44, which is used to control the soft connection part 43 to be in a relaxed state or a tensioned state.

Specifically, as shown in FIG. 19 , in one possible implementation, the control member 44 includes a support member 441 fixedly provided at the proximal end of the first delivery rod 41 and a rotation shaft rotatably penetrated in the support member 441 442, wherein the axial direction of the rotating shaft 442 is perpendicular to the axial direction of the first delivery rod 41, and the proximal end of the soft connector 43 is fixedly connected to the rotating shaft 442 by winding or bonding. In this way, when the rotating shaft 442 rotates forward, the rotating shaft 442 drives the soft connector 43 to wrap around the outer peripheral surface of the rotating shaft 442, so that the soft connector 43 is in a tensioned state; when the rotating shaft 442 rotates reversely, The rotating shaft 442 drives the roll The soft connector 43 around the outer circumferential surface of the rotation axis 442 is released, so that the soft connector 43 is in a relaxed state. The support member 441 can serve as a bearing for the rotating shaft 442 .

As shown in FIG. 20 , in another possible implementation, the control member 44 may include a rotating cylinder 443 and a sliding block 444 inserted in the rotating cylinder 443 , wherein the rotating cylinder 443 can rotate around its own axis and relative to the third A conveying rod 41 is fixedly arranged in the axial direction, the sliding block 444 is threadedly connected to the rotating cylinder 443, and the proximal end of the soft connecting piece 43 is fixedly connected to the sliding block 444 by adhesion or other means. It is easy to understand that when the rotating drum 443 is rotated, the sliding block 444 can move axially relative to the first conveying rod 41 . In this way, when the rotating drum 443 rotates in the forward direction, the rotating drum 443 can drive the sliding block 444 to move proximally along the axial direction relative to the first conveying rod 41, and then pull the soft connecting piece 43 so that the soft connecting piece 43 is in tension. When the rotating drum 443 rotates reversely, the rotating drum 443 drives the sliding block 444 to move axially distally relative to the first conveying rod 41, thereby loosening the soft connector 43 so that the soft connector 43 is in a relaxed state.

Further, please refer to Figures 7 and 8 again. In the embodiment of the present application, the delivery device 40 also includes a handle 45 connected to the proximal end of the first delivery rod 41. The handle 45 is used to facilitate the operator to hold and control the third delivery rod. The movement of one conveying rod 41 relative to the second conveying rod 42 . Alternatively, the aforementioned control member 44 may be provided inside the handle or outside the handle 45. Preferably, the control member 44 is provided inside the handle 45. It should be noted that the proximal end of the soft connector 43 penetrates into the handle 45 and is connected to the control member 44. The handle 45 is provided with an opening, and at least part of the control member 44 (such as the aforementioned rotating shaft 442 or rotating cylinder 443) passes through the opening. Exposed to facilitate the operator to perform corresponding operations (such as rotating the rotating shaft 442 or the rotating drum 443), thereby controlling the tension or relaxation of the soft connector 43.

It can be understood that in order to prevent the connection between the soft connector 43 and the second conveying rod 42 from falling off, or the connection between the soft connector 43 and the control member 44 from falling off, in the embodiment of the present application, the soft connector 43 and the second transport rod 42 are connected to each other. The connection strength of the connection between the two conveying rods 42 or the connection between the soft connection 43 and the control part 44 should be large enough, and preferably the connection can withstand a tensile force greater than 60N.

The following will describe the use process of the valve clamping system 1 provided by the first embodiment of the present application by taking the treatment of mitral valve regurgitation as an example with reference to FIGS. 21 to 24 .

Step 1: As shown in Figure 21, control the soft connector 43 to be in a tensioned state through the control member 44 on the handle 45, keep the first docking part 411 and the second docking part 422 in docking, and clamp the valve through the delivery device 40 The clamp 20 is delivered to the mitral valve, and then the two clamps 25 of the valve clamp 20 are controlled to open and close relatively to clamp the anterior leaflet and the posterior leaflet of the mitral valve.

Step 2: As shown in Figure 22, control the pulled soft connector 43 to switch from the tensioned state to the relaxed state through the control member 44, and control the first delivery rod 41 to move toward the proximal end, so that the first docking part 411 The first conveyor rod 41 and the second conveyor rod 42 can be separated by uncooperating with the second butt portion 422. During this process, the soft connector 43 should be fully relaxed to ensure that the soft connector 43 in the relaxed state is located at the first conveyor rod 41. The length of the portion between the distal end and the proximal end of the second delivery rod 42 is greater than or equal to the separation distance between the first docking part 411 and the second docking part 422 . At this time, the soft connector 43 is still connected to the control member 44 and the second delivery rod 42, and the second delivery rod 42 is still connected to the valve clamp 20 that holds the mitral valve leaflets. The operator can use equipment such as an ultrasound machine to To evaluate the effectiveness of mitral regurgitation improvement. During the evaluation process, the valve clamp 20 is in a state close to final release (that is, the delivery device 40 is completely separated from the valve clamp 20 ), and the movement of the valve clamped by the valve clamp 20 is basically not affected by the delivery device 40 of containment, which is conducive to more accurate assessment of the reflux improvement effect.

Step 3: As shown in Figure 23, if the effect of the valve clamp 20 on improving mitral regurgitation is not satisfactory, the operator can re-control the tension of the soft connector 43 through the control part 44, and then control the first delivery The rod 41 moves toward the distal end along the guidance of the soft connector 43 until the first docking part 411 and the second docking part 422 are docked and matched again, and then the valve clamping device 20 can be adjusted and controlled (such as first controlling the valve clamping). Open the device 20 to release the valve leaflets, adjust the direction and position of the valve clamper 20, and then re-control the valve clamper 20 to capture and clamp the valve leaflets again), and then repeat the second step until the desired regurgitation improvement effect is achieved.

Step 4: As shown in Figure 24, when the effect of the valve clamp 20 on improving mitral regurgitation is ideal, the soft connecting member 43 is tightened through the control member 44, and then the first delivery rod 41 is controlled to move along the The guidance of the soft connector 43 moves toward the distal end until the first docking part 411 and the second docking part 422 are re-butted and matched, so that the first delivery rod 41 and the second delivery rod 42 are docked again through the guidance of the soft connector 43, and then control The second delivery rod 42 is disconnected from the valve clamp 20, and then withdraws the delivery device 40 to the outside of the body. The valve clamp 20 clamps the mitral valve leaflets in a self-locking state and remains in the human body.

It can be understood that after the second step, if the valve clamp 20 has a satisfactory effect on improving mitral valve regurgitation, it can be directly Continue to step 4.

It should be noted that after the third step, if the effect of the valve clamp 20 on improving the mitral regurgitation still fails to achieve the desired effect, the operator can control the first delivery rod 41 and the second delivery rod 41 . After the rod 42 is docked again under the guidance of the soft connector 43, the connection between the second delivery rod 42 and the valve clamp 20 is maintained, and then the valve clamp 20 is controlled to release the leaflets, and the valve clamp 20 is adjusted to the closed position automatically. lock state, and finally the valve clamp 20 and the delivery device 40 are withdrawn from the body together.

Please refer to Figures 25 and 26 together. The structure of the valve clamping system provided by the second embodiment of the present application is basically similar to that of the valve clamping system 1 provided by the first embodiment. The difference is that in the second embodiment , the number of the soft connector 43 is one, and the first delivery rod 41 has a corresponding lumen 412 along the axis line, and the soft connector 43 slides through the lumen 412 at the axis center line of the first delivery rod 41 . The first delivery rod 41 can not only push toward the distal end or retract toward the proximal end along the axial direction, but also rotate. However, since the soft connector 43 slides through the lumen 412 at the axis of the first delivery rod 41 Therefore, the rotation of the first conveying rod 41 will not cause the soft connector 43 to be entangled, and the soft connector 43 will not hinder the first docking part 411 and the second docking part 422 from being docked.

In addition, the difference from the first embodiment is that in the second embodiment of the present application, the cooperation between the first docking part 411 and the second docking part 422 adopts a threaded structure. Specifically, as shown in FIG. 25 As shown, the first docking part 411 is a stud with external threads protruding from the distal end of the first delivery rod 41, and the second docking part 422 is an internally threaded hole opened at the proximal end of the second delivery rod 42. The first part 411 and the second butt part 422 are detachably connected through threaded connection. It can be understood that when realizing the connection or separation of the first docking part 411 and the second docking part 422, it is necessary to rotate the first conveying rod 41, but as mentioned above, the rotation of the first conveying rod 41 will not cause The winding of the soft connector 43 can prevent the soft connector 43 from hindering the butt-fitting of the first docking portion 411 and the second docking portion 422 .

Preferably, please refer to Figure 27. In another embodiment, the first docking part 411 is provided with a first guide structure 4112, and the second docking part 422 is provided with a second guide structure adapted to the first guide structure 4112. 4222, the first guide structure 4112 and the second guide structure 4222 cooperate with each other to achieve a docking guide effect, thereby making the docking of the first docking part 411 and the second docking part 422 faster and more accurate. Specifically, in this embodiment, the first docking part 411 is a tapered stud with an outer diameter that gradually decreases from the proximal end to the distal end and has an external thread, and its tapered outline constitutes the first guide structure 4112. The portion 422 is an inverse-tapered internal threaded hole with an inner diameter gradually increasing from the proximal end to the distal end, and its inverted-tapered internal contour correspondingly constitutes the second guide structure 4222. In this way, the first guide structure 4112 and the second guide structure 4222 cooperate. , the first docking part 411 can be quickly aligned with the second docking part 422, and then the first docking part 411 and the second docking part 422 are threaded by rotating the first conveying rod 41, thereby improving the accuracy and efficiency of docking.

Figures 28 to 31 illustrate the use process of the valve clamping system provided by the second embodiment of the present application for the treatment of mitral valve regurgitation, and the use of the valve clamping system 1 provided by the first embodiment of the present application for the treatment of mitral valve. The usage process of reflux is basically the same. The difference is that the connection or separation of the first docking part 411 and the second docking part 422 needs to be achieved by rotating the first delivery rod 41. In addition, the specific content of each step is The contents of each step in the first embodiment are similar and will not be described again.

Please refer to Figures 32 to 34 together. The structure of the valve clamping system provided by the third embodiment of the present application is basically similar to that of the valve clamping system 1 provided by the first embodiment. The difference is that in the third embodiment of the present application In the embodiment, the first delivery rod 41 is provided with a pair of lumens 412 corresponding to each soft connector 43, and the second delivery rod 42 is provided with a U-shaped penetration cavity 423 corresponding to each soft connector 43. The two openings of the cavity 423 penetrate through the proximal end surface of the second delivery rod 42 .

As shown in Figures 33 and 34, in the third embodiment of the present application, each soft connector 43 has two free ends and a folded end located between the two free ends, and the two free ends are soft connections. The proximal end of the component 43 passes through the proximal end of a corresponding pair of lumens 412. The folded end is the distal end of the soft connector 43 and penetrates into a corresponding U-shaped penetration cavity 423. The soft connector 43 The distal end is movably connected to the second delivery rod 42. Preferably, in the third embodiment, the diameter of the U-shaped through cavity 423 is the same as the diameter of the lumen 412 in the first delivery rod 41 to keep the soft connector 43 between the first delivery rod 41 and the first delivery rod 41 . The coordination of sliding in the cavity of the second delivery rod 42; furthermore, the two openings of the U-shaped penetration cavity 423 are provided on the proximal end surface of the second delivery rod 42, preferably with the corresponding one on the first delivery rod 41. The opening of the lumen 412 is aligned to improve the tightness when the first butt joint part 411 and the second butt joint part 422 are butt together.

It can be understood that the use of the valve clamping system provided in the third embodiment of the present application for treating regurgitation is different from that in the third embodiment. The process of using the valve clamping system 1 provided in one embodiment for treating regurgitation is basically the same and will not be described again.

Please refer to FIGS. 35 to 37 . The structure of the valve clamping system provided by the fourth embodiment of the present application is basically similar to that of the valve clamping system 1 provided by the first embodiment. The difference lies in that: in the fourth embodiment of the present application, , the valve clamp 20 includes a connecting rod 21 fixedly arranged on the base 23, the delivery device 40 only includes one delivery rod 41, the distal end of the delivery rod 41 is provided with a first docking portion 411, and the proximal end of the connecting rod 21 is provided with a first docking portion 411. In the two butt parts 212 , the distal end of the soft connector 43 is connected to the proximal end of the connecting rod 21 , and the soft connector 43 is at least partially movably inserted through the delivery rod 41 . That is to say, in the fourth embodiment of the present application, the conveying rod 41 is equivalent to the first conveying rod 41 in the first embodiment, and the connecting rod 21 is equivalent to the second conveying rod 42 in the first embodiment. By controlling the soft connector 43 to switch between the relaxed state and the tensioned state, the separation and connection between the conveying rod 41 and the connecting rod 21 can be realized.

It can be understood that when the soft connector 43 is in a relaxed state, the first docking part 411 and the second docking part 212 are allowed to loosen and separate from each other, so that the conveying rod 41 and the connecting rod 21 are separated. At this time, only the loose soft connector 43 in the delivery device 40 is connected to the valve clamp 20, and the valve clamp 20 is in a state close to final release (that is, the delivery device 40 and the valve clamp 20 are completely separated), which is equivalent to The structural and force connection between the valve clamp 20 and the delivery device 40 is interrupted, and the movement of the valve leaflets clamped by the valve clamp 20 is basically not restricted by the delivery device 40, thereby facilitating a more accurate assessment of regurgitation. Improve results. If it is evaluated that the reflux improvement effect is not ideal, the proximal end of the soft connector 43 can be pulled to re-make the partially movable soft connector 43 that penetrates the delivery rod 41 into a tensioned state, so that the delivery rod 41 can be in a tensioned state. The soft connector 43 moves under the guidance of the first docking part 411 and the second docking part 212 so that the delivery rod 41 is reconnected to the connecting rod 21, thereby reconnecting the delivery device 40 to the valve clamp 20. At this time, the valve clamp 20 can be adjusted and controlled by controlling the self-locking mechanism and the driving mechanism of the valve clamp 20, so that the valve clamp 20 can unlock and re-capture and clamp the valve leaflets, which helps to improve Reflux improvement effect. If it is evaluated that the effect of improving regurgitation is ideal, it is only necessary to release the connection between the soft connector 43 and the connecting rod 21 of the valve clamp 20 in the relaxed state of the soft connector 43 (such as connecting the soft connector 43 with the connecting rod 21 of the valve clamp 20 The connecting end of the connecting rod 21 is cut off), and then the entire delivery device 40 is controlled to be withdrawn from the patient's body, so that the valve clamp 20 is finally released and placed in the patient's heart.

It should be noted that in this embodiment, the soft connector 43 should be larger than the preset length, so that the distance between the separated delivery rod 41 and the connecting rod 21 is large enough, so that when the valve clamp 20 clamps When the regurgitation improvement effect is evaluated behind the valve leaflets, the delivery rod 41 will not hinder the connecting rod 21 and the valve clamp 20 in which it is located from moving with the valve leaflets. Among them, those skilled in the art can understand that the corresponding preset length of the soft connector 43 is related to the use occasion of the valve clamp 20 . Specifically, when the valve clamp 20 is used to perform edge-to-edge repair of the mitral valve, the preset length is the axial length of the delivery rod 41, the axial length of the connecting rod 21 and the desired length of the valve clamp 20. The sum of the upper and lower diameters of the left atrium of the implanted heart; when the valve clamp 20 is used to perform edge-to-edge repair of the tricuspid valve, the preset length is the axial length of the delivery rod 41 and the axis of the connecting rod 21 The length is the sum of the upper and lower diameters of the right atrium of the heart into which the valve clamp 20 is to be implanted. In the embodiment of the present invention, the length of the soft connector 43 is preferably greater than 1000 mm.

Please refer to Figures 8, 9, and 35 to 38. In the fourth embodiment of the present application, the first docking portion 411 is a tenon block protruding from the distal end of the delivery rod 41 (see Figures 8 and 9). The second docking part 212 is a mortise and tenon opened at the proximal end of the connecting rod 21 (see Figure 38); as shown in Figures 35 and 37, when the delivery rod 41 moves axially toward the distal end of the tenon block ( That is, when the first butt portion 411) is inserted into the mortise at the proximal end of the connecting rod 21 (that is, the second butt portion 212), the conveying rod 41 is connected to the connecting rod 21; as shown in Figure 36, when the conveying rod 41 moves along the axis When the tenon block that moves toward the proximal end to its distal end is disengaged from the mortise hole at the proximal end of the connecting rod 21, the delivery rod 41 and the connecting rod 21 are separated. In other embodiments, the first docking part 411 may be a mortise and tenon opened at the distal end of the delivery rod 41 , and accordingly, the second docking part 212 may be a tenon block protruding from the proximal end of the connecting rod 21 , and the two may also cooperate. The connection or separation between the conveying rod 41 and the connecting rod 21 is realized, which will not be described in detail. In other embodiments, the first docking part 411 and the second docking part 212 may also adopt a matching structure other than the mortise and tenon structure, such as a threaded structure or a snap structure, and the two may also cooperate with each other. The connection or separation of the conveying rod 41 and the connecting rod 21 is realized.

Among them, the first docking part 411 and the second docking part 212 respectively have the same structure and function as the first docking part 411 and the second docking part 422 in the first embodiment. For a more detailed description, please refer to the above related content, here No longer.

Similarly, the conveying rod 41, the connecting rod 21 and the soft connecting piece 43 respectively have the same structures and features as the first conveying rod 41, the second conveying rod 42 and the soft connecting piece 43 in the first embodiment. A more detailed description can be See the related content above, in This will not be described again.

For detailed descriptions of the handle 45, the control member 44 connected to the proximal end of the soft connector 43, etc., please refer to the above-mentioned relevant content, and will not be described again here.

As shown in FIGS. 35 to 37 , in the fourth embodiment of the present application, the valve clamp 20 further includes a pair of first clamping arms 22 that can be opened and closed relative to the connecting rod 21 . The holding arm 22 is preferably arranged symmetrically with respect to the axis of the connecting rod 21 . The distal end of each first clamping arm 22 is rotatably connected to the base 23 . The first clamping arm 22 can rotate to be close to or away from the connecting rod 21 . A pair of first clamping arms 22 are used to oppose the connecting rod 21 Open and close to hold a pair of valve leaflets, such as the anterior leaflet and posterior leaflet of the mitral valve, or any two of the anterior leaflet, septal leaflet and posterior leaflet of the tricuspid valve, and the pair of valve leaflets can be Pull together to achieve edge-to-edge repair of the valve. Preferably, in this embodiment, the valve clamp 20 further includes a second clamping arm 24. A second clamping arm 24 is disposed correspondingly between a first clamping arm 22 and the connecting rod 21. The distal end of the arm 24 is fixedly connected to the base 23. The first clamping arm 22 can rotate to be close to or away from the corresponding second clamping arm 24. The first clamping arm 22 and the second clamping arm 24 cooperate with each other to achieve alignment. Capturing, clamping or releasing the leaflets can improve the success rate and reliability of clamping the leaflets. Further preferably, in this embodiment, the valve clamp 20 also includes an elastic adjustment member (not shown in the figure), which is fixedly sleeved on the connecting rod 21 along the axial direction of the connecting rod 21, or the elastic adjusting member The proximal end or/and the distal end are sleeved on the connecting rod 21 along the axial movement of the connecting rod 21. In this way, when the valve clamp 20 successfully clamps the valve leaflets and is in a self-locking state, a pair of second clamping devices The arm 24 squeezes the elastic adjustment member, and the elastic adjustment member is subsequently squeezed by the second clamping arms 24 to deform and fill and seal the space between the inner sides of the second clamping arms 24, so that the second The spaces between the clamping arms 24 are no longer hollow, and the open gaps between the leaflets corresponding to the second clamping arms 24 are also blocked by the elastic adjustment members, which can avoid central regurgitation in the center of the valve clamp 20 phenomenon to improve the treatment effect on reflux; furthermore, the elastic adjustment member can also push against each second clamping arm 24, thereby adjusting the degree of pulling of the valve leaflets by the valve clamper 20 to adapt to different valve leaflets. spacing. The elastic adjustment member may adopt a mesh structure woven from shape memory alloy wires, or may adopt a solid structure made of elastic materials such as silicone, which is not limited. In other embodiments, the valve clamp 20 may also include more than two first clamping arms 22 and corresponding more than two second clamping arms 24, thereby realizing clamping of more than two valve leaflets, As long as it is ensured that the valve clamp 20 can clamp or release the valve leaflets, and self-lock or unlock, no further details will be given.

It should also be noted that the difference from the first embodiment is that in the fourth embodiment of the present application, the valve clamping system 1 also includes a shearing instrument. When the distal end of the soft connector 43 is fixedly connected, When the proximal end of the rod 21 is removed, if the delivery device 40 needs to be withdrawn from the patient's body, the distal end of the soft connector 43 can be cut with a shearing instrument, so that the delivery device 40 can be withdrawn smoothly.

The following will describe the use process of the valve clamping system 1 provided by the fourth embodiment of the present application, taking the treatment of mitral valve regurgitation as an example with reference to FIGS. 39 to 42 .

Step 1: As shown in Figure 39, control the soft connector 43 to be in a tensioned state through the control member 44 on the handle 45, keep the first docking part 411 and the second docking part 212 in docking, and clamp the valve through the delivery device 40 The clamp 20 is delivered to the mitral valve, and then the two first clamping arms 22 of the valve clamp 20 are controlled to open and close relative to the connecting rod 21 to clamp the anterior leaflet and the posterior leaflet of the mitral valve.

Step 2: As shown in Figure 40, control the pulled soft connector 43 to switch from the tensioned state to the relaxed state through the control member 44, and control the delivery rod 41 to move toward the proximal end, so that the first docking part 411 and the second When the two butt parts 212 are released from mating, the conveying rod 41 and the connecting rod 21 can be separated. During this process, the soft connecting piece 43 should be fully relaxed to ensure that the soft connecting piece 43 in the relaxed state is located at the far end of the conveying rod 41 and the connecting rod 21 The length of the portion between the proximal ends is greater than or equal to the separation distance between the first butt portion 411 and the second butt portion 212 . At this time, the soft connector 43 is still connected to the control member 44 and the connecting rod 21. The valve clamp 20 where the connecting rod 21 is located clamps the mitral valve leaflets. The operator can use ultrasound equipment and other equipment to detect mitral valve reaction. Evaluate the effect of flow improvement. During the evaluation process, the valve clamp 20 is in a state close to final release (that is, the delivery device 40 is completely separated from the valve clamp 20 ), and the movement of the valve clamped by the valve clamp 20 is basically not affected by the delivery device 40 of containment, which is conducive to more accurate assessment of the reflux improvement effect.

Step 3: As shown in Figure 41, if the effect of the valve clamp 20 on improving mitral regurgitation is not satisfactory, the operator can re-control the tension of the soft connector 43 through the control part 44, and then control the delivery rod 41 Move toward the distal end along the guidance of the soft connector 43 until the first docking part 411 and the second docking part 212 are docked and matched again, and then the valve clamp 20 can be adjusted. Control (for example, first control the valve clamp 20 to open and release the valve leaflets, adjust the direction and position of the valve clamp 20, and then re-control the valve clamp 20 to capture and clamp the valve leaflets again), and then repeat the second step until the Ideal for reflux improvement.

Step 4: As shown in Figure 42, when the effect of the valve clamp 20 on improving mitral regurgitation is ideal, use the shearing instrument 60 (such as interventional scissors) to cut the distal end of the soft connector 43. Cut the soft connector 43 at its connection end with the connecting rod 21, and the valve clamp 20 is completely released, and then the delivery device 40 is withdrawn outside the patient's body. The valve clamp 20 clamps the mitral valve leaflets and is in a It remains in the patient's body in a self-locking state.

It can be understood that after the second step, if the valve clamp 20 has a satisfactory effect on improving mitral valve regurgitation, the fourth step can be directly performed.

It should be noted that after the third step, if the effect of the valve clamp 20 on improving mitral regurgitation still fails to achieve the desired effect, the operator can control the delivery rod 41 and the connecting rod 21 through the soft After the connector 43 is guided and docked again, maintain the connection between the delivery rod 41 and the connecting rod 21, then control the valve clamp 20 to release the leaflets, adjust the valve clamp 20 to a closed self-locking state, and finally clamp the valve The device 20 and the delivery device 40 are removed from the body together.

Please refer to Figures 26 and 43 together. The structure of the valve clamping system provided by the fifth embodiment of the present application is basically similar to that of the valve clamping system 1 provided by the fourth embodiment. The difference is that in the fifth embodiment , the number of the soft connector 43 is one, and the delivery rod 41 has a corresponding lumen 412 along the axis line, and the soft connector 43 slides through the lumen 412 at the axis center line of the delivery rod 41 . The delivery rod 41 can not only push toward the distal end or retract toward the proximal end along the axial direction, but also rotate. However, since the soft connector 43 slides through the lumen 412 at the axis of the delivery rod 41, the delivery The rotation of the rod 41 will not cause the soft connector 43 to be entangled, thus preventing the soft connector 43 from hindering the butt-fitting of the first docking portion 411 and the second docking portion 212 .

In addition, the difference from the fourth embodiment is that in the fifth embodiment of the present application, the cooperation between the first docking part 411 and the second docking part 212 adopts a threaded structure. Specifically, as shown in FIG. 43 As shown, the first docking part 411 is a stud with external threads protruding from the distal end of the delivery rod 41, and the second docking part 212 is an internally threaded hole opened at the proximal end of the connecting rod 21. The first docking part 411 and the The two butt parts 212 are detachably connected through threaded connection. It can be understood that when realizing the connection or separation of the first docking part 411 and the second docking part 212, it is necessary to rotate the conveying rod 41, but as mentioned above, the rotation of the conveying rod 41 will not cause the soft connector 43 to Therefore, it is possible to avoid the soft connector 43 from hindering the first docking part 411 and the second docking part 212 from being docked.

Preferably, please refer to Figure 44. In another embodiment, the first docking part 411 is provided with a first guide structure 4112, and the second docking part 212 is provided with a second guide structure adapted to the first guide structure 4112. 2122, the first guide structure 4112 and the second guide structure 2122 cooperate with each other to achieve a docking guide effect, thereby making the docking of the first docking part 411 and the second docking part 212 faster and more accurate. Specifically, in this embodiment, the first docking part 411 is a tapered stud with an outer diameter that gradually decreases from the proximal end to the distal end and has an external thread, and its tapered outline constitutes the first guide structure 4112. The portion 212 is an inverse-tapered internal threaded hole with an inner diameter gradually increasing from the proximal end to the distal end, and its inverted-tapered internal profile accordingly constitutes the second guide structure 2122. In this way, the first guide structure 4112 and the second guide structure 2122 cooperate. , the first docking part 411 can be quickly aligned with the second docking part 212, and then the threaded connection between the first docking part 411 and the second docking part 212 is achieved by rotating the conveying rod 41, thereby improving the accuracy and efficiency of docking.

Figures 45 to 48 illustrate the use process of the valve clamping system provided by the fifth embodiment of the present application for the treatment of mitral valve regurgitation, and the use of the valve clamping system 1 provided by the fourth embodiment of the present application for the treatment of mitral valve. The process of using the reflux is basically the same. The difference is that the connection or separation of the first docking part 411 and the second docking part 212 needs to be realized by rotating the delivery rod 41. In addition, the specific content of each step is the same as that in the second step. The contents of each step in the four embodiments are similar and will not be described again.

Please refer to Figures 49 to 52 together. The structure of the valve clamping system provided by the sixth embodiment of the present application is basically similar to that of the valve clamping system 1 provided by the fourth embodiment. The difference is that in the sixth embodiment of the present application In the embodiment, the delivery rod 41 is provided with a pair of lumens 412 corresponding to each soft connector 43, and the connecting rod 21 is provided with a U-shaped penetration cavity 213 corresponding to each soft connector 43. The U-shaped penetration cavity 213 is Two openings penetrate the proximal end surface of the connecting rod 21 .

As shown in Figures 50 and 51, in the sixth embodiment of the present application, each soft connector 43 has two free ends and a folded end located between the two free ends. The two free ends are soft connections. The proximal end of the member 43 passes through the proximal end of a corresponding pair of lumens 412. The folded end is the distal end of the soft connecting member 43 and passes through a corresponding U-shaped passing cavity 213. The soft connection The distal end of the member 43 is movably connected to the connecting rod 21. Preferably, in the third embodiment, the diameter of the U-shaped through cavity 213 is the same as the diameter of the lumen 412 in the delivery rod 41 to keep the soft connector 43 between the delivery rod 41 and the connecting rod 21 The coordination of sliding in the cavity; furthermore, the two openings of the U-shaped penetration cavity 213 are provided on the proximal end surface of the connecting rod 21, and are preferably aligned with the openings of the corresponding pair of lumens 412 on the delivery rod 41 to improve The tightness when the first docking part 411 and the second docking part 212 are docked.

It can be understood that the use process of the valve clamping system provided by the sixth embodiment of the present application for treating regurgitation is basically the same as the use process of the valve clamping system 1 provided by the fourth embodiment for treating regurgitation. This will not be described in detail.

However, it should be noted that in the sixth embodiment of the present application, the soft connector 43 is movably connected to the connecting rod 21. Therefore, when the connection between the soft connector 43 and the connecting rod 21 is released, as shown in Figure 52, It is only necessary to extract the soft connector 43 from the U-shaped penetration cavity 213, and there is no need to transport additional shearing instruments to cut the soft connector 43, making the operation simpler.

The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the technical field, several improvements and modifications can be made without departing from the principles of the embodiments of the present application. These improvements and modifications can also be made. regarded as the protection scope of this application.

Claims

A valve clamping system, characterized in that it includes a delivery device and a valve clamper, and the delivery device is used to transport the valve clamper;

Wherein, the delivery device includes a delivery rod and a soft connector, and the delivery rod is detachably connected to the valve clamp;

The soft connector has a relaxed state and a tensioned state; when the valve clamp clamps the valve for regurgitation assessment, the soft connector is configured to be in the relaxed state to interrupt the valve clamp. The structural and force coherence between the coupling and the conveying rod of the conveying device.
The valve clamping system of claim 1, wherein the delivery rod includes a first delivery rod and a second delivery rod;

The distal end of the first delivery rod is provided with a first docking portion;

The distal end of the second delivery rod is detachably connected to the valve clamp, and the proximal end of the second delivery rod is provided with a second docking portion, and the second docking portion is used to cooperate with the first docking portion. , so that the second conveying rod can be detachably connected to the first conveying rod; the distal end of the soft connecting piece is connected to the second conveying rod, and the soft connecting piece is at least partially movably threaded through the first conveying rod. Inside a conveyor rod;

Wherein, in the relaxed state of the soft connector, the first butt joint part and the second butt joint part can be disengaged, so that the first conveyor rod and the second conveyor rod can be separated; in In the tensioned state, the first conveying rod can move along the soft connector until the first docking part and the second docking part cooperate, so that the first conveying rod connects to the second docking part. Conveyor rod.
The valve clamping system of claim 1, wherein the delivery rod is an integral structure with a first docking portion provided at its distal end; the valve clamping device includes a connecting rod, and the proximal portion of the connecting rod is The end is provided with a second docking part, the second docking part is used to cooperate with the first docking part so that the connecting rod can be detachably connected to the conveying rod;

Wherein, the distal end of the soft connector is connected to the connecting rod, and at least part of the soft connector is movably inserted into the delivery rod; in the relaxed state of the soft connector, the third The mating portion and the second mating portion can be disengaged to separate the conveying rod from the connecting rod; in the tensioned state, the conveying rod can move along the soft connector to the The first butt portion cooperates with the second butt portion so that the conveying rod is connected to the connecting rod.
The valve clamping system according to claim 2 or 3, characterized in that the first butt joint part and the second butt joint part adopt one of a thread structure, a mortise and tenon structure, or a buckle structure.
The valve clamping system of claim 2, wherein the first delivery rod is provided with a lumen extending in the axial direction and penetrating both ends of the first delivery rod, and the lumen is used to slide through The soft connector;

The distal end of the soft connector passes through the distal end of the lumen and is connected to the second delivery rod, and the proximal end of the soft connector passes out of the proximal end of the lumen.
The valve clamping system of claim 2, wherein the first delivery rod is provided with a lumen extending obliquely relative to its axial direction, and the lumen penetrates the distal surface of the first delivery rod and Peripheral wall, the lumen is used to slide through the soft connector;

The distal end of the soft connector passes through the distal end of the lumen and is connected to the second delivery rod, and the proximal end of the soft connector passes through the proximal end of the lumen and is along the first The outer peripheral wall of the delivery rod extends beyond the proximal end of the first delivery rod.
The valve clamping system according to claim 5 or 6, characterized in that the number of the soft connectors is one or more, and the first delivery rod is provided with a soft connector corresponding to each of the soft connectors. lumen;

Each of the soft connectors has a linear structure, and the distal end of the soft connector is fixedly connected to the second delivery rod.
The valve clamping system of claim 5 or 6, wherein the number of the soft connectors is one or more, and the first delivery rod is provided with a pair of corresponding soft connectors corresponding to each of the soft connectors. The lumen, and the second delivery rod is provided with a U-shaped penetration cavity corresponding to each of the soft connectors, and the two openings of the U-shaped penetration cavity penetrate the proximal end surface of the second delivery rod;

Each of the soft connectors has two free ends and a folded end located between the two free ends. The two free ends are the proximal ends of the soft connectors and pass through the corresponding pair of lumens. The proximal end, the folded end is the distal end of the soft connector And is inserted into a corresponding U-shaped insertion cavity, and the distal end of the soft connector is movably connected to the second delivery rod.
The valve clamping system of claim 2 or 3, wherein the first docking part is provided with a first guide structure, and the second docking part is provided with a third guide structure adapted to the first guide structure. 2. Guidance structure.
The valve clamping system according to any one of claims 1 to 3, wherein the delivery device further includes a control member, the proximal end of the soft connector is connected to the control member, and the control member is used to The soft connecting piece is controlled to be in the relaxed state or the tensioned state; the conveying device further includes a handle, and the control member is arranged inside the handle or outside the handle.
The valve clamping system of claim 2, wherein the length of the soft connector is greater than the preset length;

The preset length is the sum of the axial length of the first delivery rod, the axial length of the second delivery rod and the upper and lower diameters of the left atrium of the heart where the valve clamp is to be implanted; or the The preset length is the sum of the axial length of the first delivery rod, the axial length of the second delivery rod and the upper and lower diameters of the right atrium of the heart into which the valve clamp is to be implanted.
The valve clamping system according to any one of claims 1 to 3, characterized in that the soft connector is made of at least one flexible wire or flexible band, and the flexible wire is a single-strand wire or a multi-strand wire.
The valve clamping system of claim 12, wherein the bending force required when the soft connector is bent to 90 degrees or close to 90 degrees is less than 0.1N.
The valve clamping system of claim 13, wherein the soft connector is made of biocompatible metal materials, polymer materials or composite materials.
The valve clamping system according to any one of claims 1 to 3, wherein the soft connector is provided with a development mark.
The valve clamping system of claim 3, wherein the delivery rod is provided with a lumen extending in the axial direction and penetrating both ends of the delivery rod, and the lumen is used to slide through the soft connection. piece; the distal end of the soft connector goes out of the distal end of the lumen and is connected to the connecting rod, and the proximal end of the soft connector goes out of the proximal end of the lumen.
The valve clamping system of claim 3, wherein the delivery rod is provided with a lumen that extends obliquely relative to its axial direction, and the lumen penetrates the distal surface and peripheral wall of the delivery rod, so The lumen is used to slide through the soft connector; the distal end of the soft connector passes through the distal end of the lumen and is connected to the connecting rod, and the proximal end of the soft connector passes through the The proximal end of the lumen extends beyond the proximal end of the delivery rod along the peripheral wall of the delivery rod.
The valve clamping system according to claim 16 or 17, wherein the number of the soft connectors is one or more, and the delivery rod is provided with a lumen corresponding to each of the soft connectors. ; Each of the soft connectors has a linear structure, and the distal end of the soft connector is fixedly connected to the connecting rod;

The valve clamping system further includes a shearing instrument for shearing the distal end of the soft connector.
The valve clamping system of claim 16 or 17, wherein the number of the soft connectors is one or more, and the delivery rod is provided with a pair of tubes corresponding to each of the soft connectors. cavity, and the connecting rod is provided with a U-shaped penetration cavity corresponding to each of the soft connectors, and the two openings of the U-shaped penetration cavity penetrate the proximal end surface of the connecting rod;

Each of the soft connectors has two free ends and a folded end located between the two free ends. The two free ends are the proximal ends of the soft connectors and pass through the corresponding pair of lumens. In addition to the proximal end, the folded end is the distal end of the soft connector and is inserted into a corresponding U-shaped penetration cavity. The distal end of the soft connector is movably connected to the connecting rod.
The valve clamping system of claim 3, wherein the axial length of the soft connector is greater than the preset length;

The preset length is the sum of the axial length of the delivery rod, the axial length of the connecting rod and the upper and lower diameters of the left atrium of the heart where the valve clamp is to be implanted; or the preset length is The sum of the axial length of the delivery rod, the axial length of the connecting rod and the upper and lower diameters of the right atrium of the heart where the valve clamp is to be implanted.