CN113230000A

CN113230000A - Valve clip removal system

Info

Publication number: CN113230000A
Application number: CN202110587675.0A
Authority: CN
Inventors: 陈茂; 冯沅; 边英男; 郝长宁
Original assignee: Yingmai Medical Technology Shanghai Co ltd
Current assignee: Yingmai Medical Technology Shanghai Co ltd
Priority date: 2021-05-27
Filing date: 2021-05-27
Publication date: 2021-08-10
Also published as: WO2022247682A1

Abstract

The invention discloses a valve clip removal system, comprising: a capture channel configured to be placed adjacent a valve clip, a resection channel configured to be placed adjacent a valve gripped by the valve clip, a capture fixture (200) for passing through the capture channel and capturing the valve clip, and a resection device (300) for passing through the capture channel and capturing the valve clip, the resection device (300) for passing through the resection channel and placing adjacent the valve after the valve clip is captured, and resecting at least a portion of the valve to remove the valve clip. The valve clip removal system provided by the invention realizes the removal of the valve clip through the system design, is simple and convenient in operation process, and is prepared for patients to receive subsequent transcatheter valve replacement and other operations.

Description

Valve clip removal system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a valve clip removal system.

Background

The incidence of heart valves is related to the increase of age, and the incidence of heart valves is obviously increased along with the coming of aging. Among them, Mitral Regurgitation (MR) is a common valvular disease. Mitral regurgitation is the abnormal flow of blood from the left ventricle into the left atrium when the heart contracts. Severe mitral regurgitation can cause patients to have symptoms such as palpitation, shortness of breath, chest distress and the like, and the death rate of severe mental failure patients is more than 30 percent each year.

For patients with mitral valve regurgitation, surgical open-chest valve repair or valve replacement is often used. With the development of transcatheter valve technology, transcatheter mitral valve clamps have also been used to improve regurgitation. The principle of mitral valve clips is to mimic the edge-to-edge technique in surgical repair. The catheter is introduced into one or more mitral valve clips through the right femoral vein, and the coaptation area of the anterior and posterior valve leaflets is increased by respectively clamping the anterior and posterior valve leaflets through the two ends of the clips, so that the mitral valve regurgitation is reduced. Currently, the MitraClip clip is widely used.

However, this type of mitral valve clip also has significant drawbacks. In some patients, mitral regurgitation is still evident after the mitral valve clip is implanted, requiring removal of the original mitral valve clip and re-implantation of the mitral valve clip. There are also some patients who experience a relapse of mitral regurgitation after years of implantation, in which case the treatment options that may be selected include more thorough transcatheter mitral valve replacement. With transcatheter mitral valve replacement, the originally implanted mitral valve clip prevents release and deployment of the prosthetic mitral valve, requiring removal of the implanted mitral valve clip. The traditional approach to removing the mitral valve clip is to use a surgical open chest procedure, which presents a significant risk to the patient.

Valve clip removal systems also exist in the prior art, by way of intervention, to remove the mitral valve clip. These valve clip removal systems, however, suffer from one or more of the following disadvantages. For example, a capture catheter with magnetic elements and a cutting catheter in a valve clip removal system that includes a capture catheter with magnetic elements may affect electrical devices in the operating room during use or other devices in the operating room during operation, resulting in connection failures; connected by magnetic elements at the tip of the capturing catheter and the end of the cutting member, and then the catheter is manipulated to pull the cutting member past one side of the valve clip to cut the valve leaflets. There is a great risk that the magnetic element is only attracted to counteract the resistance during the traction process, for example, the operator may separate the magnetic elements by applying too much force during the traction process, and finally the cutting may fail.

Accordingly, there is a significant need in the art for a valve clip removal system that overcomes at least one of the above-described disadvantages in preparation for a patient undergoing a subsequent procedure such as a transcatheter valve replacement procedure.

Disclosure of Invention

To address one or more of the above issues, the present invention provides a valve clip removal system comprising: a capture channel, a resection channel, a capture fixture, and a resection device,

the capture channel is configured to be positioned adjacent to a valve clip, the resection channel is configured to be positioned adjacent to a leaflet that the valve clip clamps, the capture fixation device is configured to pass through the capture channel and capture the valve clip, and the resection device is configured to pass through the resection channel and be positioned adjacent to the leaflet after the valve clip is captured and resect at least a portion of the leaflet to remove the valve clip.

In another preferred embodiment, the capture fixture includes a capture fixture and a capture fixture catcher, the capture channel includes a first capture channel in which the capture fixture catcher is movable and a second capture channel in which the capture fixture is movable.

In another preferred embodiment, the capture fixture catcher includes a capture fixture catch feature, and the capture fixture includes a capture fixture lead-in through which the capture fixture catch feature and the capture fixture lead-in cooperate to effect connection of the capture fixture catcher with the capture fixture.

In another preferred embodiment, the capture fixture capture feature has a mesh structure.

In another preferred embodiment, the net structure of the capture fixture capture member is circular, oval or spindle shaped.

In another preferred embodiment, the capture fixture lead-in head has a barb-like or barb-like structure.

In another preferred embodiment, the capture fixture further comprises a capture fixture component for capturing and fixing the valve clip.

In another preferred embodiment, the capturing fixture part has a planar web structure provided with a crotch structure.

In another preferred embodiment, the capture anchor further comprises a first capture anchor pull wire and a second capture anchor pull wire, the capture anchor lead-in is disposed at a distal end of the first capture anchor pull wire, and the capture anchor member is disposed between the first capture anchor pull wire and the second capture anchor pull wire.

In another preferred example, the valve clip removal system further comprises a capture fixation catheter for providing the capture channel.

In another preferred embodiment, the capture immobilization conduit comprises a first capture immobilization conduit for providing the first capture channel and a second capture immobilization conduit for providing the second capture channel.

In another preferred embodiment, the resection device comprises a resection member, a resection member capture, the resection channel comprising a first resection channel in which the resection member capture is movable and a second resection channel in which the resection member is movable.

In another preferred embodiment, the resection member capture comprises a resection member capture feature, and the resection member comprises a resection member lead-in head, the connection between the resection member and the resection member capture being achieved by cooperation of the resection member lead-in head and the resection member capture feature.

In another preferred example, the resection member capture member has a mesh structure.

In another preferred embodiment, the net structure of the resection member capture member is circular, oval or spindle shaped.

In a further preferred embodiment, the resection introduction head has a closure structure, a barb-like structure or a barb-like structure.

In another preferred example, the cutting member further includes a cutting member cutting portion for cutting at least a portion of the leaflet.

In another preferred embodiment, the cutting part of the cutting part has a saw-tooth structure or is made of a high-temperature oxidation-resistant metal material.

In another preferred embodiment, the resection member further comprises a first resection member traction wire and a second resection member traction wire, the resection member introduction head is disposed at a distal end of the first resection member traction wire, and the resection member cutting portion is disposed between the first resection member traction wire and the second resection member traction wire.

In another preferred example, the valve clip removal system further comprises a resection catheter for providing the resection channel.

In another preferred embodiment, the ablation catheter comprises a first ablation catheter for providing the first ablation channel and a second ablation catheter for providing the second ablation channel.

In another preferred example, the valve clip removal system further comprises a capture fixation catheter for providing the capture channel, a resection catheter for providing the resection channel, and a protection catheter for providing a channel for the capture fixation catheter and the resection catheter, avoiding friction between the capture fixation catheter, the resection catheter and human tissue during movement.

In another preferred example, the valve clip is a mitral valve clip for mitral valve repair or a tricuspid valve clip for tricuspid valve repair.

It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be reiterated herein, but to the extent of space.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below. It is to be understood that the drawings in the following description are merely exemplary embodiments of the invention and that one skilled in the art may, without any inventive step, derive other embodiments from these drawings.

FIG. 1 is a schematic structural view of a capture fixture of a valve clip removal system according to one embodiment of the present invention;

FIG. 2 is an enlarged detail view of the distal structure of the capture fixture of the valve clip removal system of one embodiment of the present invention;

FIG. 3 is a schematic illustration of the capture fixture of one embodiment of the present invention;

FIG. 4 is a diagram of a capture fixture and cardiac structure arrangement according to one embodiment of the present invention;

FIGS. 5(a) -5 (c) are schematic views of a process of capturing a stationary valve clip of a capture fixture according to one embodiment of the present invention;

FIG. 6 is a schematic structural view of a resection device of the valve clip removal system of one embodiment of the present invention;

FIG. 7 is an enlarged detail view of the distal structure of the removal device of one embodiment of the present invention;

FIG. 8 is a schematic view of the cut-out of a removal device according to one embodiment of the present invention;

fig. 9(a) -9 (c) are schematic views of a process of cutting a valve clip of a cutting device according to an embodiment of the present invention.

In the drawings, the designations are as follows:

100-protective catheter

200-Capture fixation device

220-Capture fixation catheter

220 a-first Capture fixation catheter

220 b-second Capture fixation catheter

210-Capture Fixture

2101-Capture Fixture lead-in

2102-Capture Fixture Components

2103 a-first Capture Fixture Pull wire

2103 b-second Capture Fixture Pull wire

2104-catch mount development point

221-catch fixture catcher

2210-capture fastener capture component

2211-Capture Mount catcher development Point

300-resection device

320-resection catheter

320 a-first ablation catheter

320 b-second ablation catheter

310-resection piece

3101-resection member introducer

3102-resection piece cutting

3103A-first resection member traction wire

3103b second resection member traction wires

3104-development site of resection

321-resection member capture device

3210-resection piece catcher catch feature

3211-development point of the cut-off catcher

400-valve leaflet

500-valve clip

Detailed Description

The present inventors, through extensive and intensive studies, have disclosed for the first time a valve clip removal system having a capturing fixture and a resection device with smart capturing fixture and resection structure, by capturing and fixing a valve clip, such as a mitral valve clip or a tricuspid valve clip, only by the capturing fixture of the capturing fixture provided in a protective catheter, withdrawing the capturing fixture, and then loading the resection device in the protective catheter so that the resection structure cuts the valve clip. Therefore, the valve clip removing system of the invention uses the same protective tube to remove the valve clip, and the operation process is simple. Furthermore, the capture fixture capture catches provided in the capture fixture of the present invention are similar in construction to the resection member capture catches of the resection device of the present invention, thereby simplifying the difficulty of manufacture.

Term(s) for

As used herein, the terms "valve clip" and "clip" are used interchangeably;

as used herein, the terms "capture fixture" and "fixture" are used interchangeably;

it is noted that, in the present patent application, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, the use of the verb "comprise a" to define an element does not exclude the presence of another, same element in a process, method, article, or apparatus that comprises the element. In the present patent application, if it is mentioned that a certain action is executed according to a certain element, it means that the action is executed according to at least the element, and two cases are included: performing the action based only on the element, and performing the action based on the element and other elements. The expression of a plurality of, a plurality of and the like includes 2, 2 and more than 2, more than 2 and more than 2.

In the present invention, all the directional indications (such as up, down, left, right, front, rear, etc.) are used only to explain the relative positional relationship between the respective members, the motion situation, etc. in a certain posture (as shown in the drawing), and if the certain posture is changed, the directional indication is changed accordingly.

In the present invention, unless otherwise specified, "distal" refers to a side closer to the patient and farther from the operator, and "proximal" refers to a side closer to the operator and farther from the patient.

Valve clip removal system

The system comprises: capture channel, resection channel, capture fixation device 200, resection device 300;

the capture channel is configured to be placed adjacent to the valve clip 500, the resection channel is configured to be adjacent to the valve leaflet 400 clamped by the valve clip 500, the capture fixation device 200 is configured to pass through the capture channel and capture and fix the valve clip 500, and the resection device 300 is configured to be placed adjacent to the valve leaflet 400 through the resection channel after the valve clip 500 is captured and resect at least a portion of the valve leaflet 400 to remove the valve clip 500.

Preferably, the capture fixture 200 includes a capture fixture 210 and a capture fixture catcher 221, the capture channels including a first capture channel in which the capture fixture catcher 221 is movable and a second capture channel in which the capture fixture 210 is movable.

Preferably, the capture fixture capture 221 includes capture fixture capture features 2210 and the capture fixture 210 includes capture fixture lead-in 2101 with the capture fixture capture features 2210, capture fixture lead-in 2101 mated to effect connection of the capture fixture capture 221 with the capture fixture 210.

Preferably, the capture fixture 210 includes a capture fixture member 2102, and the capture fixture member 2102 is used for capturing and fixing the valve clip 500.

Preferably, the resection device 300 comprises a resection member 310, a resection member catch 321, the resection channel comprising a first resection channel in which the resection member catch 321 is movable and a second resection channel in which the resection member 310 is movable.

Preferably, the resection member capture 321 comprises a resection member capture feature 3210 and the resection member 310 comprises a resection member lead-in 3101, the connection between the resection member 310 and the resection member capture 321 being achieved by cooperation of the resection member lead-in 3101 with the resection member capture feature 3210.

Preferably, the resection member 310 includes a resection member cut 3102, the resection member cut 3102 being used to resect at least a portion of the leaflet 400.

Preferably, the valve clip removal system further comprises a protective catheter 100, wherein the protective catheter 100 is used for providing a channel for the capturing and fixing catheter 220 and the cutting catheter 320, and avoiding repeated friction between the capturing and fixing catheter 220 and the cutting catheter 320 and human tissues during movement.

Method of removing a valve clip

The method comprises the following steps:

(1) the capture channel is disposed adjacent to the valve clip 500;

(2) passing the capture fixation device 200 through the capture channel and capture-fixing the valve clip 500;

(3) disposing the resection channel adjacent to the leaflet 400 gripped by the valve clip 500;

(4) the resection device 300 is placed adjacent to the valve leaflet 400 through the resection channel and resected to at least a portion of the valve leaflet 400 to remove the valve clip 500.

Preferably, in step (1), the capturing channel includes a first capturing channel disposed at one side of the valve clip 500 and a second capturing channel disposed at the other side of the valve clip 500.

Preferably, in step (2), the capture fixture 200 comprises a capture fixture 210 and a capture fixture catcher 221, the capture fixture catcher 221 is driven to one side of the valve clip 500 through a first capture channel, the capture fixture 210 is driven to the other side of the valve clip 500 through a second capture channel, and the capture fixture catcher 221, the capture fixture 210 are further driven to protrude distally and to be attached above (e.g., transapical) or below (e.g., transseptal) the valve clip 500 to capture the valve clip 500.

In step (2), the capture fixture 200 comprises a capture fixture 210 and a capture fixture catcher 221, the capture fixture catcher 221 is driven through a first capture channel to one side of the valve clip 500, and the capture fixture 210 is driven through a second capture channel to the other side of the valve clip 500; the capture fixture catches 221, the capture fixture 210 are further actuated to extend distally and attach over (e.g., transapical) or under (e.g., transseptal) the valve clip 500 to capture the valve clip 500.

In the step (3), the resection channels include a first resection channel disposed at one side of the leaflet 400 and a second resection channel disposed at the other side of the leaflet 400.

In step (4), the resection device 300 comprises a resection member 310, a resection member capture 321, the resection member capture 321 is driven through a first resection channel to one side of the leaflet 400, and the resection member 310 is driven through a second resection channel to the other side of the leaflet 400; the resection member 310, resection member capture 321, is further actuated to extend distally and attach above (e.g., transapical) or below (e.g., transseptal) the leaflet 400 and resect the leaflet 400.

In the following description, numerous technical details are set forth in order to provide a better understanding of the present invention. However, it will be understood by those skilled in the art that the claimed invention may be practiced without these specific details and with various changes and modifications based on the following embodiments. In the following embodiments, a valve clip for clamping mitral valve leaflets is exemplified, but this is not intended to limit the scope of the present invention.

Examples

Referring to fig. 1-8, the present embodiment provides a valve clip 500 removal system comprising: capture channel, resection channel, capture fixation device 200, resection device 300. The capture channel is configured to be placed adjacent to a valve clip 500, the resection channel is configured to be placed adjacent to a leaflet 400 of a mitral valve that is clamped by the valve clip 500, the capture fixation device 200 is configured to pass through the capture channel and capture the fixation valve clip 500, and the resection device 300 is configured to be placed adjacent to the leaflet 400 of the mitral valve through the resection channel after the valve clip 500 is captured, and resect at least a portion of the leaflet 400 of the mitral valve to remove the valve clip 500.

As shown in fig. 1, the capture fixture 200 includes a capture fixture 210, a capture fixture catcher 221. Accordingly, the capture channels include a first capture channel and a second capture channel. The first capture channel is for receiving capture fixture catch 221 and the second capture channel is for receiving capture fixture 210. Capture fixture 210 is free to move within the second capture channel and at least partially extends beyond the distal end of the second capture channel. The capture fixture capture 221 is free to move within the first capture channel and may extend at least partially beyond the distal end of the first capture channel. When the capture channel is located adjacent to the valve clip 500, for example, the first capture channel is on one side of the valve clip 500 and the second capture channel is on the other side of the mitral valve clip 500, the capture fixture 210 extends from the second capture channel, and the capture fixture catcher 221 extends from the first capture channel and is attached to the capture fixture 210 over the valve clip 500 to capture and secure the valve clip 500.

The capture fixture capture 221 includes capture fixture capture features 2210 for coupling with the capture fixture 210. As shown in fig. 2, the capture fixture capture component 2210 has a mesh structure. The net structure can be made of shape memory metal or polymer material. The net structure can be a plane net structure or a three-dimensional net structure. The network may be spindle-shaped. In other embodiments, the mesh structure of the capture fixture capture component 2210 may also be designed to be circular or elliptical. Illustratively, the capturing fixture capture features 2210 are fusiform dense mesh made of PET material, or a spherical mesh woven and cut from nitinol wire. Further, a capture fixture pull wire is provided proximal to the capture fixture capture component 2210 for driving movement of the capture fixture capture component 2210. The capture fixture pull wire may be a metal material, such as stainless steel wire, nickel titanium wire.

Capture anchor 210 includes capture anchor lead 2101, capture anchor member 2102. The capture fixture lead-in 2101 is used to connect with the capture fixture capture feature 2210 to effect a connection between the capture fixture capture 221 and the capture fixture 210. The capture fastener component 2102 is used to capture and secure the valve clip 500. As shown in FIG. 3, the capture fixture lead 2101 has a barbed, barb-like configuration that makes it more easily captured by the capture fixture capture feature 2210. Capture fastener component 2102 is a planar mesh structure. Preferably, the planar mesh structure is further provided with a crotch structure to further wrap around the valve clip 500, increasing the probability of capture and fixation. Further, the capture fixture 210 also includes a first capture fixture pull wire 2103a and a second capture pull wire 2103 b. The capture anchor lead 2101 is disposed distal to a first capture anchor pull wire 2103a, and capture anchor member 2102 is disposed between first capture anchor pull wire 2103a and second capture anchor pull wire 2103 b. Further, for ease of handling, the second capture pull wires 2103b may be made of a different material, e.g., the portion proximal to the capture anchor member 2102 may be made of a more rigid material, while the portion distal to the capture anchor member 2102 may be made of a more flexible material.

To better show the location of the capture fixture capture catches 221 and the capture fixtures 210, the capture fixture capture catches 221 are provided with capture fixture capture catch development points 2211, such as capture fixture capture development points 2211 at one or both ends of the capture fixture capture features 2210; capture fixture 210 is also provided with capture fixture development points 2104, for example, two capture fixture development points 2104 are provided at each end of capture fixture assembly 2102.

Further, the valve clip removal system includes a capture fixation catheter 220, and the capture channel is located on the capture fixation catheter 220. In the present embodiment, as shown in fig. 1, the capturing immobilization catheter 220 includes a first capturing immobilization catheter 220a, a second capturing immobilization catheter 220 b. The first capture channel is located in the first capture immobilization conduit 220a and the second capture channel is located in the second capture immobilization conduit 220 b. In other embodiments, the first capture channel and the second capture channel may be disposed in the capture fixation catheter 220, i.e., both channels are disposed in the same catheter.

When the valve clip 500 is captively fixed by the capturing and fixing device 200, the capturing and fixing catheter 220 is disposed near the valve clip 500, for example, a first capturing and fixing catheter 220a is disposed on one side of the valve clip 500, and a second capturing and fixing catheter 220b is disposed on the other side of the valve clip 500. The capture fixation catcher 221 is deployed on one side of the valve clip 500 by a first capture fixation catheter 220a, and the capture fixture 210 is deployed on the other side of the valve clip 500 by a second capture fixation catheter 220 b. The capture fixation catch 221 is driven at least partially out of the distal end of the first capture fixation catheter 220a and the capture fixture 210 is driven at least partially out of the distal end of the second capture fixation catheter 220b until the capture fixation catch 2210 of the capture fixation catch 221 catches the capture fixture lead-in 2101 of the capture fixture 210 above the valve clip 500, thereby capturing the fixation catch 221 and the capture fixture 210 as a unit. Further, pulling on the proximal end of the capture fastener catch 221 causes the capture fastener catch 221 to move proximally, and the corresponding capture fastener 210 continues to extend distally from the second capture fastener catheter 220b until the capture fastener introducer 2101 extends out of the proximal end of the first capture fastener catheter 220a and the capture fastener member 2102 captures the valve clip 500. After removal of the capture fixture capture catches 221, the first and second

capture fixation catheters

220a, 220b are removed. The first and second capture

fixture pull wires

2103a, 2103b are then knotted to effect fixation of the valve clip 500. The capture fixture capture catches 221 are removed from the protective catheter 100. The manner in which the first capture fastener pull wire 2103a and the second capture fastener pull wire 2103b are tied is not particularly limited in this embodiment and may be done manually or by a knotter.

The resection device 300 includes a resection member 310, a resection member catch 321. Accordingly, the resection channel includes a first resection channel and a second resection channel. The first resection channel is for receiving the resection member capture 321 and the second resection channel is for receiving the resection member 310. The resection member 310 is free to move within the second resection channel and may extend at least partially beyond the distal end of the second resection channel. The resection member catch 321 is freely movable within the first resection channel and at least partially extendable beyond the distal end of the first resection channel. When the resection channel is configured to be positioned adjacent to the leaflets 400 of the mitral valve, e.g. the first resection channel is positioned on one side of the leaflets 400 of the mitral valve and the second resection channel is positioned on the other side of the leaflets of the mitral valve, the resection member 310 extends from the distal end of the second resection channel, the resection member catch 321 extends from the distal end of the first resection channel, is connected to the resection member 310 over the leaflets 400 of the mitral valve, and resects at least part of the leaflets 400 of the mitral valve, e.g. the leaflet edges, to remove the valve clip 500.

The resection member catch 321 comprises a resection member catch member 3210. As shown in fig. 7, the resection member catch member 3210 has a mesh-like structure. Similar to the structure of the capture fixture catcher 221, the mesh structure may be made of a shape memory metal or a polymer material. The net structure can be a plane net structure or a three-dimensional net structure. The network may be spindle-shaped. In other embodiments, the resection member catch member 3210 is designed to be circular or oval. Illustratively, the resection member capture member 3210 is a fusiform dense mesh made of PET material, or a spherical mesh woven and cut from nitinol wire. Further, a resection member pull wire is provided proximal to the resection member capture member 3210 for driving movement of the resection member capture member 3210. The resection member traction wire may be a metal material, such as a stainless steel wire, a nickel titanium wire.

The resection member 310 includes a resection member lead-in head 3101, a resection member cutting portion 3102. The resection member lead-in head 3101 is used to connect with the resection member capture feature 3210 to effect a connection between the resection member 310 and the resection member capture 321. The resection member cut 3102 is used to resect at least a portion of the leaflet 400, such as the leaflet edge. Further, the cutting of the resection member 310 may be mechanical or electrical, such as the resection member 310 having a saw-tooth structure to saw the valve 400 of the mitral valve from the clamped portion and the remaining unclamped portion of the valve clip 500 in a saw-like manner (like a wire cut), or the resection member 310 being made of a high temperature, oxidation resistant metallic material, by energizing the resection member 310 such that high temperature is generated at the resection member cutting portion 3102 to resect a portion of the mitral valve leaflets 400 to remove the valve clip 500 (like a thermal ablation or a high frequency surgical knife). As shown in fig. 8, the resection lead 3101 has a closed configuration, such as a loop, so that it is more easily captured by the resection member capture member 3210. In other embodiments, the structure of the resection lead 3101 can also be similar to the structure of the capture fixture lead 2101. The resection member cutting portion 3102 is linear with a saw tooth structure to facilitate cutting of the mitral valve 400. The resection device 310 further includes a first resection device pull wire 3103a and a second resection device pull wire 3103b, the resection device lead-in 3101 is disposed at the distal end of the first resection device pull wire 3103a, and the resection device cut 3102 is disposed between the first resection device pull wire 3103a and the second resection device pull wire 3103 b.

To better show the position of the resection member capture device 321 and the resection member 310, a resection member capture device development point 3211 is provided on the resection member capture device 321, for example at one or both ends of a resection member capture member 3210; the cut piece 310 is provided with a cut piece development point 3104, and for example, two cut piece development points 3104 are provided at both ends of the cut piece portion 3102, respectively.

Further, the valve clip removal system includes a resection catheter 320, the resection channel being located at the resection catheter 320. In this embodiment, the ablation catheter 320 includes a first ablation catheter 320a and a second ablation catheter 320b, the first ablation channel being disposed in the first ablation catheter 320a, and the second ablation channel being disposed in the second ablation catheter 320 b. In other embodiments, the first ablation channel and the second ablation channel may be disposed in ablation catheter 320, i.e., both channels are disposed in the same catheter.

After completing the tying of the first capture fastener pull wire 2103a and the second capture fastener pull wire 2103b, the resection catheter 320 is disposed proximate the leaflets 400 of the mitral valve, e.g., the first resection catheter 320a is disposed on one side of the leaflets 400 of the mitral valve and the second resection catheter 320b is disposed on the other side of the leaflets 400 of the mitral valve. Through the first resection catheter 320a, the resection piece grabber 321 is deployed at one side of the valve 400 of the mitral valve; the resection member 310 is deployed on the other side of the valve 400 of the mitral valve by means of a second resection catheter 320 b. The resection member capture feature 3210 is driven out of the distal end of the first resection catheter 320a and the resection member lead-in 3101 is driven out of the second resection catheter 320b until the resection member capture feature 3210 captures the resection member lead-in 3101 over the leaflets 400 of the mitral valve, whereby the resection member 310, the resection member capture 321 form one piece. In turn, the resection member capture 321 is driven proximally and the resection member 310 continues to move distally such that the resection member introducer head 3101 of the resection member 310 extends out of the proximal end of the first resection catheter 320 a. After removal of the resection member capture 321, the first and

second resection catheters

320a, 320b are removed. The resection member 310 is operated to cut the leaflets 400 of the mitral valve. After cutting the leaflets 400 on both sides of the mitral valve, the valve clip 500 can be removed.

Further, the distal ends of the capture fixation catheter 220 (e.g., the first capture fixation catheter 220a and the second capture fixation catheter 220b) and the ablation catheter 320 (e.g., the first ablation catheter 320a and the second ablation catheter 320b) are configured to be steerable. Illustratively, the distal end of the capture fixation catheter 220 includes a serpentine bone structure and a control wire to control rotation of the serpentine bone structure. Steering control of the capture fixation catheter 220 is achieved by control wires and serpentine structures. As another example, the distal end of the ablation catheter 320 includes a flexible, resilient portion. Steering control of the ablation catheter 320 is achieved by a flexible, resilient portion. In this manner, by controlling the capture fixation catheter 220, the resection catheter 320, the capture fixation 210 and capture fixation capture catch 221 are more easily controlled and accessible, and the capture fixation capture 2210 more easily captures and secures the capture fixation introduction head 2101.

The valve clip removal system also includes a protective catheter 100. The protective catheter 100 is used for providing a channel for the capturing and fixing catheter 220 and the cutting catheter 320, and avoiding repeated friction between the capturing and fixing catheter 220 and the cutting catheter 320 and human tissues during movement. In this embodiment, the protective catheter 100 is placed at the apex of the heart near the left ventricle so that the capture and fixation catheter 220, the resection catheter 320 can reach the mitral valve leaflets 400, near the valve clip 500, transapically. In other embodiments, the protective catheter 100 can also be positioned at the interatrial septum so that the capture fixation catheter 220, the resection catheter 320 can reach through the interatrial septum to the vicinity of the leaflets 400, the valve clips 500 of the mitral valve.

4-5, 9, the manner in which the valve clip 500 removal system of the present embodiment is used is further described in a transapical manner for ease of understanding. FIG. 4 shows a capture fixture 200 in accordance with the present invention in a view with a cardiac structure; fig. 5(a) -5 (c) are schematic process views of a capture fixation valve clip 500 of the capture fixation device 200 according to one embodiment of the present invention; fig. 9(a) -9 (c) are schematic views of a process of cutting a valve clip 500 of a cutting device 300, according to one embodiment of the present invention.

Brief description of the operation of a valve clip removal system according to one embodiment of the present invention includes: (1) the capture channel is disposed adjacent to the valve clip 500; (2) passing a capture fixture 200 through the capture channel and capturing the valve clip 500; (3) disposing the resection channel adjacent to the leaflet 400 gripped by the valve clip 500; (4) the resection device 300 is placed adjacent to the valve leaflet 400 through the resection channel and resected to at least a portion of the valve leaflet 400 to remove the valve clip 500.

In step (1), the capture channel includes a first capture channel disposed on one side of the valve clip 500 and a second capture channel disposed on the other side of the valve clip 500.

Further, after the first capture channel is disposed on one side of the valve clip 500 and the second capture channel is disposed on the other side of the valve clip 500, a first distance between a distal end of the first capture channel and a distal end of the second capture channel is controlled to be smaller than a second distance between a proximal end of the first capture channel and a proximal end of the second capture channel, so that the capture and fixation device 200 can capture and fix the valve clip 500 more easily. Illustratively, the valve clip removal system includes a first capture fixation catheter 220a and a second capture fixation catheter 220 b. The first capture channel, the second capture channel are disposed in the first capture immobilization conduit 220a and the second capture immobilization conduit 220b, respectively. The distal ends of the first and second

capturing fixation catheters

220a, 220b are configured for steerable bending. Controlling the first distance between the distal end of the first capture channel and the distal end of the second capture channel to be less than the second distance between the proximal end of the first capture channel and the proximal end of the second capture channel is accomplished by controlling the degree of curvature of the distal ends of the first and second

capture fixation catheters

220a, 220 b.

Further, the valve clip removal system also includes a protective catheter 100. Before step (1), the protection catheter 100 is inserted into the heart wall (e.g., apex) or heart space (e.g., interatrial septum) to provide a passage for the capturing and fixing catheter 220 and the cutting catheter 320, so as to avoid repeated friction between the capturing and fixing catheter 220 and the cutting catheter 320 and human tissues during movement.

Further, after the valve clip 500 is captured, the capture fixture 200 is operated such that both ends of the capture fixture 210 are placed outside the body and the capture fixture part 2102 captures the valve clip 500, and then the capture fixture 210 is knotted to fix the valve clip 500.

Further, the capture fixture capture 221 includes capture fixture capture features 2210, and the capture fixture 210 includes capture fixture lead-in 2101, with the capture fixture capture features 2210, capture fixture lead-in 2101 being actuated to mate to effect connection of the capture fixture capture 221 with the capture fixture 210. Further, after the capture fixture catcher 221 is coupled to the capture fixture 210, the capture fixture catcher 221 and the capture fixture 210 are continuously driven to move, so that the capture fixture part 2102 covers the valve clip 500 to capture the valve clip 500 while both ends of the capture fixture 210 are placed outside the body.

Further, after the first resection channel is disposed on one side of the leaflet 400 and the second resection channel is disposed on the other side of the leaflet 400, a first distance between a distal end of the first resection channel and a distal end of the second resection channel is controlled to be smaller than a second distance between a proximal end of the first resection channel and a proximal end of the second resection channel to make it easier for the resection device 300 to resect the leaflet 400.

Further, the resection member capture 321 comprises a resection member capture feature 3210 and the resection member 310 comprises a resection member lead-in 3101, the resection member lead-in 3101 being urged into engagement with the resection member capture feature 3210 to effect a connection between the resection member 310 and the resection member capture 321. Further, the cut-off 310 further includes a cut-off cutting portion 3102, and after the connection between the cut-off 310 and the cut-off catcher 321 is achieved, the cut-off 310 and the cut-off catcher 321 are continuously driven to move so that both ends of the cut-off 310 are placed outside the body, and the cut-off cutting portion 3102 is driven to act on the leaflet 400 to perform the cutting. The term "action" here is, for example, mechanical, for example sawing, thermal, for example ablation. After the resection of one leaflet is completed, the remaining leaflet resection may be completed in a similar manner as described above.

Taking the valve clip 500 holding the mitral valve leaflets 400 as an example, a specific description is made of the method of removing the valve clip:

(a) the protection catheter 100 is arranged at the apex of the heart of a human body in a penetrating way;

(b) deploying the first capturing fixation catheter 220a at one side of the valve clip 500 and the second capturing fixation catheter 220b at the other side of the valve clip 500 through the protection catheter 100, and controlling the distal ends of the first capturing fixation catheter 220a and the second capturing fixation catheter 220b to be bent to approach each other, as shown in fig. 5 (a);

(c) operating the capture fixture 200 so that the capture fixture capture 221 passes through the first capture fixture conduit 220a and extends distally and the capture fixture 210 passes through the second capture fixture conduit 220b and extends distally until the capture fixture capture feature of the capture fixture capture 221 mates with the capture fixture lead-in 2101 of the capture fixture 210 to effect connection of the capture fixture capture 221 and capture fixture 210, as shown in FIG. 5 (b);

(d) operating the capture fixture 200 such that the capture fixture catches 221 extend proximally, the capture fixture 210 extends distally, until both ends of the fixture 210 are outside the body, and the capture fixture part 2102 captures the valve clip 500;

(e) withdrawing the capture fixture catcher 221, the first capture fixture catheter 220a and the second capture fixture catheter 220b, and then knotting the first capture fixture pull wire 2103a and the second capture pull wire 2103b of the capture fixture 210 to secure the valve clip 500, as shown in fig. 5 (c);

(f) deploying the first ablation catheter 320a at one side of the leaflets 400 of the mitral valve, deploying the second ablation catheter 320b at the other side of the leaflets 400 of the mitral valve, and controlling the distal ends of the first and

second ablation catheters

320a, 320b to bend to approach each other through the protection catheter 100, as shown in fig. 9 (a);

(g) operating the resection device 300 such that the resection member capture device 321 passes through the first resection catheter 320a and extends distally, and the resection member 310 passes through the second resection catheter 320b and extends distally, until the resection member capture feature 3210 of the resection member capture device 321 and the resection member lead-in head 3101 of the resection member 310 cooperate to effect connection of the resection member capture device 321 and the resection member 310, as shown in fig. 9 (b);

(h) operating the resection device 300 such that the resection member capture device 321 extends proximally and the resection member 310 extends distally until both ends of the resection member 310 are outside the body, and then withdrawing the resection member capture device 321, the first resection catheter 320a, and the second resection catheter 320b, as shown in figure 9 (c);

(i) operating the cut portion 3102 to cut the leaflet 400, for example, controlling the cut portion 3102 to move repeatedly to cut the leaflet 400, or energizing the cut portion 3102 to ablate the leaflet 400;

(j) repeating steps (f) - (i) to process the remaining leaflets 400, and finally effecting removal of the valve clip 500.

Advantages of the invention include one or more of the following:

(a) the valve clip removing system provided by the invention has ingenious capturing and fixing structures and cutting structures, and the valve clip is captured and fixed only by the capturing and fixing structures of the capturing and fixing device arranged in the protective catheter, the capturing and fixing device is withdrawn, and then the cutting structures of the cutting device are arranged in the protective catheter and used for cutting the valve clip;

(b) the valve clip removing system disclosed by the invention has the advantages that the valve clip is removed by using the same protective tube, so that the operation process is simple and convenient;

(c) the capture fixture catcher provided in the capture fixture of the valve clip removal system of the present invention is similar in structure to the resection member catcher of the resection device of the present invention, so that the manufacture is simple and the operation of the worker is simple;

(d) only one person is needed in each step of operation, however, 2-3 persons are needed to perform the operation of the valve clip removing system in the prior art synchronously, which increases the operation difficulty.

All documents referred to in this application are to be considered as being incorporated in their entirety into the disclosure of the present invention for the purpose of making available modifications as necessary. Further, it is understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the above disclosure of the present invention, and such equivalents also fall within the scope of the claimed invention.

Claims

1. A valve clip removal system, comprising: a capture channel, a resection channel, a capture fixture (200), and a resection device (300),

the capture channel is configured to be placed adjacent to a valve clip (500), the resection channel is configured to be placed adjacent to a valve leaflet (400) clamped by the valve clip (500), the capture fixation device (200) is configured to pass through the capture channel and capture the valve clip (500), and the resection device (300) is configured to be placed adjacent to the valve leaflet (400) through the resection channel after the valve clip (500) is captured, and resect at least a portion of the valve leaflet (400) to remove the valve clip (500).

2. The valve clip removal system of claim 1, wherein the capture fixture (200) comprises a capture fixture (210) and a capture fixture catcher (221), the capture channel comprising a first capture channel in which the capture fixture catcher (221) is movable and a second capture channel in which the capture fixture (210) is movable.

3. The valve clip removal system of claim 2, wherein the capture fixture catcher (221) comprises capture fixture catch features (2210), and the capture fixture (210) comprises capture fixture lead-in heads (2101), the capture fixture catcher (221) and the capture fixture (210) being connected by the capture fixture catch features (2210) and the capture fixture lead-in heads (2101) cooperating to effect the connection of the capture fixture catcher (221) to the capture fixture (210).

4. The valve clip removal system of claim 3, wherein the capture fixture capture component (2210) has a mesh structure.

5. The valve clip removal system of claim 4, wherein the mesh structure of the capture fixture capture component (2210) is circular, oval, or spindle shaped.

6. The valve clip removal system of claim 3, wherein the capture fastener introducer (2101) has a barb-like or barb-like structure.

7. The valve clip removal system of claim 3, wherein the capture fixture (210) further comprises a capture fixture component (2102), the capture fixture component (2102) being configured to capture and secure the valve clip (500).

8. The valve clip removal system of claim 7, wherein the capture fixture member (2102) has a planar web structure provided with a crotch structure.

9. The valve clip removal system of claim 7, wherein the capture anchor (210) further comprises a first capture anchor pull wire (2103a) and a second capture pull wire (2103b), the capture anchor lead-in (2101) disposed distal to the first capture anchor pull wire (2103a), the capture anchor member (2102) disposed between the first capture anchor pull wire (2103a) and the second capture anchor pull wire (2103 b).

10. The valve clip removal system of claim 2, further comprising a capture fixation catheter (220), the capture fixation catheter (220) for providing the capture channel.

11. The valve clip removal system of claim 10, wherein the capture fixation catheter comprises a first capture fixation catheter (220a) and a second capture fixation catheter (220b), the first capture fixation catheter (220a) for providing the first capture channel and the second capture fixation catheter (220b) for providing the second capture channel.

12. The valve clip removal system of claim 1, wherein the resection device (300) comprises a resection member (310), a resection member catch (321), the resection channel comprising a first resection channel in which the resection member catch (321) is movable and a second resection channel in which the resection member (310) is movable.

13. The valve clip removal system of claim 12, wherein the resection member capture (321) comprises a resection member capture feature (3210), and wherein the resection member (310) comprises a resection member lead-in (3101), the connection between the resection member (310) and the resection member capture (321) being achieved by engagement of the resection member lead-in (3101) with the resection member capture feature (3210).

14. The valve clip removal system of claim 13, wherein the resection member capture member (3210) has a mesh-like structure.

15. The valve clip removal system of claim 14, wherein the mesh structure of the resection member capture member (3210) is circular, oval, or spindle-shaped.

16. The valve clip removal system of claim 14, wherein the resection introducer (3101) has a closed, barbed, or barbed configuration.

17. The valve clip removal system of claim 13, wherein the resection member (310) further comprises a resection member cut (3102), the resection member cut (3102) being for resecting at least a portion of the valve leaflets (400).

18. The valve clip removal system of claim 17, wherein the resection member cuts (3102) have a saw tooth structure or are made of a high temperature oxidation resistant metal material.

19. The valve clip removal system of claim 17, wherein the resection member (310) further comprises a first resection member pull wire (3103a) and a second resection member pull wire (3103b), the resection member lead-in (3101) being disposed at a distal end of the first resection member pull wire (3103a), the resection member cut (3102) being disposed between the first resection member pull wire (3103a) and the second resection member pull wire (3103 b).

20. The valve clip removal system of claim 2, further comprising a resection catheter (320), the resection catheter (320) for providing the resection channel.

21. The valve clip removal system of claim 20, wherein the ablation catheter (320) comprises a first ablation catheter (320a) and a second ablation catheter (320b), the first ablation catheter (320a) for providing the first ablation channel and the second ablation catheter (320b) for providing the second ablation channel.

22. The valve clip removal system of claim 1, further comprising a capture fixation catheter (220), a resection catheter (320), and a protection catheter (100), the capture fixation catheter (220) for providing the capture channel, the resection catheter (320) for providing the resection channel, the protection catheter (100) for providing a channel for the capture fixation catheter (220) and the resection catheter (320) to avoid friction between the capture fixation catheter (220), the resection catheter (320) and human tissue during movement.

23. The valve clip removal system of any one of claims 1-22, wherein the valve clip is a mitral valve clip for mitral valve repair or a tricuspid valve clip for tricuspid valve repair.