CN115281893A - Valve presss from both sides conveyor and valve repair system - Google Patents

Abstract

The invention relates to a valve clip conveying device and a valve repair system, wherein the valve clip conveying device comprises a main body, a conveying pipe, a catheter and a clamp controller control assembly, the conveying pipe is a bendable shaping pipe, the conveying pipe is arranged at the far end of the main body, and the far end of the conveying pipe can penetrate into the left atrium through a set part of the heart; the proximal end of the catheter is connected in the main body, the part of the catheter extending out of the main body is movably arranged in the delivery pipe in a penetrating way, the catheter can rotate around an axis relative to the delivery pipe, and the distal end of the catheter extends out of the distal end of the delivery pipe so as to be connected with the valve clamping device; the clamp control assembly is mounted on the main body and is used for connecting with the valve clamp to control the valve clamp to act. The valve clamp conveying device and the valve repair system provided by the invention have the advantages of simple structure, small axial size and short conveying path, are convenient for operators to control the moving distance and direction of the valve clamp, and solve the problems of complicated conveying process and poor controllability of the valve clamp in the prior art.

Description

Valve presss from both sides conveyor and valve repair system

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a valve clamp conveying device and a valve repair system.

Background

The heart valve refers to a valve between an atrium and a ventricle or between the ventricle and an artery, wherein an atrioventricular valve comprises a mitral valve and a tricuspid valve, the mitral valve is a two-piece valve which is attached to the periphery of an atrioventricular opening of a left atrium and is connected with papillary muscles through chordae tendineae, the function of preventing blood in the left ventricle from flowing back to the left atrium is realized, mitral regurgitation is a series of pathophysiological changes caused by poor anastomosis of anterior and posterior leaflets of the mitral valve due to organic or functional changes of mitral valve leaflets and related structures, and blood flow can flow back from the left ventricle to the left atrium during the mitral valve regurgitation.

In recent years, interventional therapy of valvular heart disease is rapidly developed due to the advantages of small trauma, relative safety, good curative effect and the like, wherein a valve repair method developed according to the technical principle of edge-to-edge suture of a surgical valve is high in safety, simple in technical principle and high in feasibility, in the operation process, an operator needs to convey a valve clamping device into a patient body by using a conveying device, in the related technology, the valve clamping device is conveyed in a remote mode through femoral arteries of the patient, and due to the fact that the conveying path is too long, the structure of an instrument is complex, the problems of complexity in the conveying process and poor controllability exist, and operation risks are greatly increased.

Disclosure of Invention

The invention aims to at least solve the problems of complicated conveying process and poor controllability of a valve clamp in the prior art. The purpose is realized by the following technical scheme:

the invention provides a valve clip conveying device, which is used for conveying a valve clip, and comprises a main body, a conveying pipe, a catheter and a clip control assembly, wherein the conveying pipe is a bendable shaping pipe and is arranged at the far end of the main body, and the far end of the conveying pipe is arranged to penetrate into the left atrium through a heart setting part; the proximal end of the catheter is connected into the main body, the part of the catheter extending out of the main body is movably arranged in the delivery pipe in a penetrating way, the catheter can rotate around an axis relative to the delivery pipe, and the distal end of the catheter extends out of the distal end of the delivery pipe so as to be connected with the valve clamping device; the clamp control assembly is mounted on the main body and is used for being connected with the valve clamp to control the valve clamp to act.

The valve clip conveying device provided by the embodiment of the invention has the advantages that the main body is convenient for an operator to hold and operate, the operator can control the conveying pipe and the catheter to reach a designated position in a patient body from an established intervention channel by moving the main body, the conveying pipe can randomly change the bending direction and the bending degree according to actual conditions, and can be shaped and kept in a set bending state; because the catheter and the delivery pipe can rotate relatively, an operator can adjust the clamping direction of the valve clamping device by rotating the catheter, and then the operator can clamp the valve clamping device on the mitral valve by operating the clamping device control assembly, thereby achieving the purpose of repairing the mitral valve. The valve clamp conveying device provided by the embodiment of the invention has the advantages of simple structure, small axial size and short conveying path, is convenient for operators to control the moving distance and direction of the valve clamp, and solves the problems of complicated conveying process and poor controllability of the valve clamp in the prior art.

In addition, the valve clip delivery device provided by the embodiment of the invention can also have the following technical characteristics:

in some embodiments of the invention, the delivery tube is provided as a metal tube.

In other embodiments of the invention, the delivery tube is configured as a bendable sheath.

In some embodiments of the invention, the valve clip delivery device further comprises a sheath bend adjustment assembly disposed on the body and coupled to the sheath to control bending of the sheath.

In some embodiments of the invention, the valve clip delivery device further comprises an angle adjustment member connected between the body and the delivery tube to adjust an angle of the delivery tube.

In a second aspect, the present invention provides a valve repair system comprising a valve clip applier and a valve clip delivery device as set forth in any of the above embodiments, the valve clip applier being removably attachable to a catheter of the valve clip delivery device, the valve clip applier comprising a plurality of relatively openable and closable clip arms and a plurality of catch arms.

The valve repair system according to the embodiment of the invention has the same advantages as the valve repair system proposed in any of the above embodiments, and the details are not repeated herein.

In addition, the valve clip delivery device provided by the embodiment of the invention can also have the following technical characteristics:

in some embodiments of the invention, the clip controller assembly of the valve clip delivery device includes a clip arm control assembly connected to the valve clip to control the opening and closing of the clip arm, and a catch arm control assembly connected to the catch arm to control the opening and closing of the catch arm.

In some embodiments of the invention, the capture arm control assembly includes a pull wire removably connected with the capture arm, a slide member for pulling the pull wire, and a lockwire member mounted on the slide member to lock the pull wire.

In some embodiments of the invention, the handle portion of the main body is provided with at least one sliding slot along which the sliding member can slide, the sliding member is provided with a sliding button, and the sliding button and the wire locking member are at least partially located outside the sliding slot.

In some embodiments of the invention, the valve repair system further comprises a stent coupled to the body of the valve clip delivery device, the body being rotatable on the stent and movable in a set direction.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like parts are designated by like reference numerals throughout the drawings. In the drawings:

FIG. 1 is a schematic front view of a valve clip delivery device;

FIG. 2 is a top schematic view of the valve clip delivery device of FIG. 1;

FIG. 3 is a second front view of the valve clip delivery device;

FIG. 4 is a top schematic view of the valve clip delivery device of FIG. 3;

FIG. 5 is a third schematic front view of the valve clip delivery device;

FIG. 6 is a top schematic view of the valve clip delivery device of FIG. 5;

FIG. 7 is a schematic view of a valve clamping and valve repairing system;

figure 8 is a schematic view of another configuration of a valve clip repair system.

Reference numerals:

1000. a valve repair system; 100. a valve clip delivery device; 200. a valve clamp;

10. a main body; 11. a handle; 111. a chute; 20. a delivery pipe; 21. a metal tube; 22. a sheath tube; 23. a sheath bending adjusting component; 30. a conduit; 40. a binder control assembly; 41. an actuator wire control mechanism; 42. a tension line control mechanism; 421. a slide button; 422. a wire locking member; 50. an angle adjusting member.

Detailed Description

The terminology used herein, in connection with the appended drawings of embodiments of the invention, is for the purpose of describing particular example embodiments only and is not intended to be limiting of the invention, e.g., the terms "comprising", "including", "having", and the like, do not denote the presence of the stated features nor do they exclude the presence of other features; the terms "first", "second", and the like do not imply a sequence or order; the terms "inner", "outer", "above", "below" are used merely for convenience in describing the relationship of one feature to another feature shown in the drawings and do not indicate that they must have a particular orientation. In the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to a direction parallel to a line connecting the center of the distal end and the center of the proximal end of the medical device in a natural state, and in the description of the present invention, the above definition is merely for convenience of description and should not be construed as limiting the present invention.

Referring to fig. 1 to 8, an embodiment of the first aspect of the present invention provides a valve clip delivery device 100, and an embodiment of the second aspect of the present invention provides a valve repair system 1000, the valve clip delivery device 100 is applied to the valve repair system 1000, the valve clip delivery device 100 is used for delivering a valve clip 200, and the specific structure of the valve clip 200 can be referred to 202210201648.X "valve clip and valve repair system".

Referring to fig. 1 to 6 in combination with fig. 7 and 8, the valve clip delivery apparatus 100 according to the present embodiment includes a main body 10, a delivery tube 20, a catheter 30 and a clip controller 40, wherein the delivery tube 20 is a flexible shaping tube, the delivery tube is disposed at a distal end of the main body 10, and the distal end of the delivery tube 20 is configured to penetrate into the left atrium through a set portion of the heart; the proximal end of the catheter 30 is connected in the main body 10, the part of the catheter 30 extending out of the main body 10 is movably arranged in the delivery pipe 20, the catheter 30 can rotate around the axis relative to the delivery pipe 20, and the distal end of the catheter 30 extends out of the distal end of the delivery pipe 20 to be connected with the valve clamping device 200; a clip control assembly 40 is mounted on the body 10, the clip control assembly 40 being connected to the valve clip 200 to control the valve clip 200 to act.

In the valve clip delivery device 100 provided by this embodiment, the main body 10 is convenient for an operator to hold and operate, the operator can control the delivery tube 20 and the catheter 30 to reach a designated position in the patient from the established intervention channel by moving the main body 10, and the delivery tube 20 can arbitrarily change the bending direction and the bending degree according to actual conditions, and can be shaped and maintained in a set bending state, for example, in an operation of applying to a mitral valve repair valve clip, the delivery tube 20 and the catheter 30 can pass through the established intervention channel, pass through the left atrial wall or the left atrial appendage of the patient, and then deliver the valve clip 200 connected to the distal end of the catheter 30 to the vicinity of the mitral valve, the operator can adjust the clipping direction of the valve clip 200 by rotating the catheter 30, and then the operator can clip the valve clip 200 onto the mitral valve by operating the clip control assembly 40, thereby achieving the purpose of repairing the mitral valve. The valve clip conveying device 100 and the valve repair system 1000 provided by the embodiment have the advantages of simple structure, small axial size, short conveying path, convenience for an operator to control the moving distance and direction of the valve clip conveying device, and the conveying pipe 20 and the catheter 30 are both independently controllable, so that the problems of complexity and poor controllability in the valve clip conveying process in the prior art are solved.

As shown in fig. 1, in the valve clip delivery apparatus 100 provided in the present embodiment, the main body 10 includes a housing, the housing may be formed by injection molding or 3D printing, and a receiving cavity is provided inside the housing, and the receiving cavity is used for receiving part of other structures of the valve clip delivery apparatus 100, such as the proximal end of the catheter 30, the clip controller assembly 40, and the like. The proximal end of the main body 10 may be provided with a handle 11, as shown in fig. 1, 3 and 5, the handle 11 may be disposed along a vertical direction for an operator to hold and operate or for connecting to other devices, the handle 11 may be connected to the main body 10 by integral molding, in an alternative embodiment, a cavity may be disposed in the handle 11, and the cavity may communicate with the accommodating cavity of the main body 10 to accommodate part of other structures of the valve clip delivery apparatus 100, such as part of the structure in the clip control assembly 40, which will be described in detail in the embodiment of the valve repair system 1000 below.

With continued reference to fig. 1 to 6, the distal end of the main body 10 has an opening communicating with the accommodating cavity, the proximal end of the catheter 30 is located in the accommodating cavity and connected to the main body 10, the catheter 30 extends from the opening and is movably disposed through the delivery tube 20, the catheter 30 can move in the delivery tube 20 and can rotate in the delivery tube 20, that is, the main body 10 and the catheter 30 can rotate around the axis relative to the delivery tube 20. Therefore, after the delivery pipe 20 is adjusted to the set bending state, the operator can rotate the main body 10 and the catheter 30 to drive the valve clamp 200 connected to the distal end of the catheter 30 to rotate, so as to adjust the clamping direction of the valve clamp 200.

Further, a vent valve or the like may be provided between the delivery pipe 20 and the main body 10 and the duct 30, and this embodiment is not particularly limited thereto. The conveying pipe 20 is set to be the bendable sizing pipe in this embodiment, it should be noted that the bendable sizing pipe in this embodiment means that the conveying pipe 20 can be bent to a set shape and restored to an initial shape by external force, and the conveying pipe 20 does not restore to deformation by itself, or the amount of deformation of the conveying pipe 20 that restores to deformation by itself is extremely small and can be ignored.

Illustratively, in some embodiments of the present invention, as shown in fig. 1 to 4 in combination with fig. 7, the delivery tube 20 is provided as a metal tube 21, for example, a heat-treated stainless steel tube, it can be understood that the heat-treated stainless steel tube can be bent under the action of external force and can be maintained in a certain bent shape, and during the actual use, an operator can bend the delivery tube 20 to a specified state by directly or indirectly bending.

Illustratively, when the direct bending mode is adopted, no additional bending mechanism is needed, and when the device is applied to a mitral valve repair operation, as shown in fig. 7, an operator can combine the actual situation of a patient and an intervention site to perform bending on the delivery pipe 20 before or at any time point during the delivery pipe 20 enters the left atrium, so as to deliver the valve clip device 200 to the mitral valve. In the embodiment, the delivery tube 20 is a metal tube 21 that can be bent and shaped, so that the overall structure of the valve clip delivery device 100 is simpler and more convenient, and the operation of an operator is facilitated.

Illustratively, in other embodiments of the invention, as shown in fig. 5 and 6 in combination with fig. 8, the delivery tube 20 is configured as a bendable sheath 22, such as a polymer sheath, and the valve clip delivery device 100 further includes a sheath bending adjusting assembly 23, wherein the sheath bending adjusting assembly 23 is disposed on the main body 10 and connected to the sheath 22 to control bending of the sheath 22. For example, the distal end of the sheath tube 22 has a bending adjusting section, a bending adjusting stay wire is extended from the bending adjusting section, the bending adjusting stay wire can be extended to be connected with the sheath tube bending adjusting assembly 23, and the bending adjusting section of the sheath tube 22 is driven to bend by pulling the bending adjusting stay wire. When applied to a mitral valve repair procedure, as shown in fig. 8, the operator can bend the delivery tube 20 after the delivery tube 20 enters the left atrium, and then deliver the valve clamp 200 to the mitral valve, in accordance with the actual condition of the patient and the intervention site. In the embodiment, the operation of an operator is facilitated by arranging the bendable sheath tube 22 and the sheath tube bending adjusting assembly 23.

Further, in some embodiments of the present invention, the valve clip delivery device 100 may further include an angle adjusting member 50, the angle adjusting member 50 is connected between the main body 10 and the delivery pipe 20 for adjusting the angle of the delivery pipe 20, and the angle adjusting member 50 and the main body 10 may be configured as a fixed connection to ensure the reliability of the connection. Illustratively, the angle adjustment member 50 may be provided as a universal ball joint or a hinge joint, so that the delivery tube 20 connected thereto can be rotated relative to the main body 10 to adjust the angle, whereby an operator can adjust the delivery tube 20 according to actual conditions, and the delivery tube 20 can deliver the valve clip 200 to a designated position.

On the basis of the above embodiments, please refer to fig. 7 and 8, a valve repair system 1000 according to an embodiment of the second aspect of the present invention includes a valve clip 200 and a valve clip delivery device 100 according to any of the above embodiments, the valve clip 200 is detachably connected to a catheter 30 of the valve clip delivery device 100, the valve clip 200 includes a plurality of oppositely opening and closing clip arms and a plurality of catching arms, when the valve clip is used in a valve repair operation, the catching arms are used for catching a valve, and the clip arms are used for clipping a valve, for example, when the valve clip 200 is used in a mitral valve repair operation, the valve clip 200 may include two oppositely opening and closing clip arms and two catching arms.

Further, as shown in fig. 1 to 8, the clip controller 40 of the valve clip delivery device 100 includes a clip arm controller and a catching arm controller, and illustratively, the clip arm controller includes an actuator wire (not shown) and an actuator wire controller 41, the actuator wire is axially movably disposed in the main body 10, and a distal end of the actuator wire is in threaded connection with the valve clip 200 via the catheter 30; an actuator wire control mechanism 41 is coupled to the actuator wire and is capable of controlling the movement of the actuator wire. In the actual use process of the valve repair system 1000, an operator controls the actuator wire control mechanism 41 to drive the actuator wire to move, so as to drive the clamping arms to open, and when the clamping arms reach the valve setting position, the operator controls the actuator wire control mechanism 41 to drive the actuator wire to move, so as to drive the clamping arms to close, so as to clamp the valve.

Further, the actuator wire control mechanism 41 can also drive the actuator wire to rotate, so that the actuator wire is separated from the valve clamp 200, and in the actual use process of the valve repair system 1000, after the valve clamp 200 is clamped on the valve, an operator controls the actuator wire control mechanism 41 to drive the actuator wire to rotate, so that the actuator wire is in threaded connection with the valve clamp 200, the valve clamp 200 is left on the valve, and valve repair is realized. The control knob of the wire control mechanism 41 in this embodiment is located outside the body 10 and may be disposed above the handle 11 for easy operation by the operator.

Further, as shown in fig. 1-8, the capturing arm control assembly of the clip control assembly 40 comprises a pulling wire (not shown) connected to the capturing arm of the valve clip 200 via the catheter 30 and a pulling wire control mechanism 42 connected to the pulling wire, wherein the pulling wire control mechanism 42 can lock the pulling wire and can pull the pulling wire to open and close the capturing arm. On this basis, the pull wire control mechanism 42 includes a slide member connected to the pull wire and capable of pulling the pull wire, and a wire locking member 422 mounted on the slide member and capable of locking the pull wire.

For example, taking the capturing arm with a preloaded elastic force and being in a closed state in an initial state as an example for description, during actual use of the valve repair system 1000, an operator may open the wire locking member 422, loosen the pulling wire, then push the sliding member, further pull the pulling wire, further drive the capturing arm to open, and after the capturing arm captures the valve, the operator may release the sliding member, so that the capturing arm automatically rebounds and cooperates with the clamping arm to further clamp the valve, thereby achieving valve repair.

Based on the above embodiment, the clip control assembly 40 is mounted on the main body 10 and partially disposed in the receiving cavity of the main body 10. As shown in FIGS. 3-6, the pull wire control mechanism 42 is at least partially disposed outside the main body 10 and can be disposed above the handle 11 for easy operation by the operator. In another alternative embodiment, as shown in fig. 1, 2 and 7, the pull wire control mechanism 42 can be disposed in the handle 11. Illustratively, at least one slide slot 111 is disposed on the handle 11 of the body 10, a slide member can slide along the slide slot 111, a slide button 421 is disposed on the slide member, and the slide button 421 and the wire locking member 422 are at least partially disposed outside the slide slot 111 for operation by an operator.

It is understood that, taking the valve clip 200 as an example with two catching arms, the pulling wire may be provided as one or two, in some embodiments of the present invention, the number of the pulling wires is two, and the two pulling wires are respectively connected to one catching arm, accordingly, as shown in fig. 1, 2 and 7, the pulling wire control mechanism 42 is provided as two, the number of the sliding slots 111 on the handle 11 is two, and the two sliding slots 111 are respectively provided on two opposite sides of the handle 11, so that the sliding buttons 421 and the locking wire members 422 of the two pulling wire control mechanisms 42 respectively extend from the two sliding slots 111, thereby facilitating the operator to operate and control the pulling wires.

Further, in some embodiments of the invention, the valve repair system 1000 further comprises a stent (not shown) that is coupled to the body 10 of the valve clip delivery device 100, such as may be coupled to a handle 11 on the body 10. The main body 10 can rotate on the support and move along a set direction, and for example, the support can be provided with a support part, and the support part can slide on the support along the axial direction and can also rotate on the support, so as to drive the main body 10 to rotate and move along the axial direction; alternatively, the stent may be provided with a sliding slot, and the main body 10 can slide along the sliding slot, which is not limited in this embodiment, and the stent in this embodiment is provided to facilitate an operator to adjust the positions and angles of the main body 10, the catheter 20, and the delivery tube 30 in the valve clip delivery apparatus 100, so as to adjust the position and angle of the valve clip device 200.

In summary, referring to fig. 1, fig. 2 and fig. 7, when the valve repair system 1000 provided in this embodiment is applied to a mitral valve repair operation, an intervention channel is pre-established in the left atrial appendage or the left atrial wall, under the guidance of esophageal ultrasound images, an operator can drive the valve clip delivery device 100 to move by operating a stent, or can hold the handle 11 of the valve clip delivery device 100 to move, so that the valve clip delivery device 100 drives the valve clip 200 to enter the left atrium through the intervention channel, and in this process, the delivery tube 20 can be bent to ensure that the valve clip 200 at the distal end of the delivery tube is close to the mitral valve; after the valve clamping device 200 reaches the designated position, an operator can rotate the main body 10 together with the catheter 20 to drive the valve clamping device 200 to rotate, so that the clamping direction of the valve clamping device is consistent with the mitral valve closing direction; then, an operator can operate the actuator wire control mechanism 41 to drive the actuator wire to move, so as to drive the clamping arms of the valve clamp 200 to open, then operate the sliding button 421 of the traction wire control mechanism 42 to drive the traction wire to move, so that the capturing arm of the valve clamp 200 is opened, then the traction wire is locked by the wire locking member 422 to stay at the position where the valve can be captured, after the position of the valve clamp 200 is finely adjusted, the traction wire is released, so that the capturing arm captures the valve, then the operator can operate the actuator wire control mechanism 41 again to drive the actuator wire to move, so as to drive the clamping arms to clamp the valve, and finally the traction wire and the actuator wire are withdrawn, so that the valve clamp 200 is clamped on the valve, and mitral valve repair is completed.

The above description is only a preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are also within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims (10)

1. A valve clamp delivery device is used for delivering a valve clamp and is characterized by comprising a main body, a delivery pipe, a catheter and a clamp control assembly, wherein the delivery pipe is set to be a bendable shaping pipe and is arranged at the far end of the main body, and the far end of the delivery pipe is set to be capable of penetrating into the left atrium through a heart setting part; the proximal end of the catheter is connected into the main body, the part of the catheter extending out of the main body is movably arranged in the delivery pipe in a penetrating way, the catheter can rotate around an axis relative to the delivery pipe, and the distal end of the catheter extends out of the distal end of the delivery pipe so as to be connected with the valve clamping device; the clamp control assembly is mounted on the main body and is adapted to connect with the valve clamp to control actuation of the valve clamp.

2. The valve clip delivery device of claim 1, wherein the delivery tube is provided as a metal tube.

3. The valve clip delivery device of claim 1, wherein the delivery tube is configured as a bendable sheath.

4. The valve clip delivery device of claim 3, further comprising a sheath bend adjustment assembly disposed on the body and coupled to the sheath to control bending of the sheath.

5. The valve clip delivery device of claim 1, further comprising an angle adjustment member connected between the body and the delivery tube to adjust an angle of the delivery tube.

6. A valve repair system comprising a valve clip delivery device according to any one of claims 1 to 5 and a valve clip holder, the valve clip holder being releasably connectable to a catheter of the valve clip delivery device, the valve clip holder comprising a plurality of relatively open and closed clip arms and a plurality of catch arms.

7. The valve repair system of claim 6, wherein the clip controller assembly of the valve clip delivery device includes a clip arm control assembly connected to the valve clip to control opening and closing of the clip arm, and a catch arm control assembly connected to the catch arm to control opening and closing of the catch arm.

8. The valve repair system of claim 7, wherein the capture arm control assembly includes a pull wire detachably connected with the capture arm, a slide member for pulling the pull wire, and a locking wire member mounted on the slide member to lock the pull wire.

9. The valve repair system of claim 8, wherein the body has at least one slide slot disposed thereon, the sliding member being slidable along the slide slot, the sliding member having a slide button disposed thereon, the slide button and the wire locking member being at least partially positioned outside of the slide slot.

10. The valve repair system of claim 6, further comprising a stent coupled to the body of the valve clip delivery device, the body being rotatable on the stent and movable in a set direction.

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