CN107789017B

CN107789017B - Mitral valve clip

Info

Publication number: CN107789017B
Application number: CN201610788399.3A
Authority: CN
Inventors: 张瑾; 杨剑; 张健; 马彩霞; 华国峰; 程海波
Original assignee: Shanghai Jinkui Medical Devices Co ltd
Current assignee: Shanghai Jinkui Medical Devices Co ltd
Priority date: 2016-08-31
Filing date: 2016-08-31
Publication date: 2020-12-01
Anticipated expiration: 2036-08-31
Also published as: CN107789017A

Abstract

The invention discloses a mitral valve clip, which comprises: two first flaps, two second flaps and a central portion; wherein one of the two ends of each first sheet is connected to the central portion, one of the two ends of each second sheet is connected to the central portion, the two first sheets can be simultaneously opened and simultaneously closed with respect to the central portion, and the two second sheets can be simultaneously opened and simultaneously closed with respect to the central portion; when the two first sheets and the two second sheets are opened, the two first sheets are both positioned at the same side of the two second sheets, and the first sheets and the second sheets form a clamp. The mitral valve clamp can be passed through a catheter into the heart and clamp the normally unoccluded mitral valve by creating a clamp between the first flap and the second flap, thereby preventing mitral regurgitation.

Description

Mitral valve clip

Technical Field

The present invention relates to a mitral valve clip.

Background

With the advent of aging population, the incidence of valvular heart disease has increased significantly. The traditional treatment mode for mitral regurgitation is valve repair or valve replacement, but the operation damage is large, and the related complications are more, so that many elderly patients with serious valvular disease cannot receive treatment. In recent years, surgical treatment of valvular heart disease is gradually minimally invasive, treatment of interventional valvular heart disease is rapidly developed due to the advantages of small trauma, relative safety, good curative effect and the like, indications of the treatment are continuously expanded, contraindications are relatively reduced, curative effect of interventional surgery is more certain, and some new technologies become new hotspots for interventional cardiology research.

Disclosure of Invention

The technical problem to be solved by the present invention is to overcome the drawbacks of the prior art and to provide a mitral valve clamp for treating a heart with a reduced risk of mitral regurgitation.

The invention solves the technical problems through the following technical scheme:

a mitral valve clip, comprising:

two first flaps, two second flaps and a central portion;

wherein one of both ends of each of the first sheets is connected to a central portion, one of both ends of each of the second sheets is connected to a central portion, the two first sheets are simultaneously openable and closable with respect to the central portion, and the two second sheets are simultaneously openable and closable with respect to the central portion;

when the two first sheets and the two second sheets are opened, the two first sheets are positioned at the same side of the two second sheets, and the first sheets and the second sheets form a clamp.

Preferably, the surface of the first sheet facing the second sheet is provided with barbs.

Preferably, the surfaces of the mitral valve clip are each coated with a fabric or surface treated so that endothelial tissue can climb the surface of the mitral valve clip.

Preferably, the material of the first and second flaps is nitinol.

Preferably, the mitral valve clip further comprises a cylindrical portion, the central portion comprises a first central piece and a second central piece sleeved outside the first central piece, the cylindrical portion is sleeved on the second central piece, the first central piece can slide relative to the second central piece, and the second central piece can slide relative to the cylindrical portion; the first sheet-like object and the second sheet-like object are both elastic components bent into a preset angle; one end of each of the two first sheets is connected with the first central piece, and one end of each of the two second sheets is connected with the second central piece.

Preferably, the first and second flaps are both thermoformed components.

Preferably, each of the first flaps includes a first leaf-shaped portion and a first rod-shaped portion, one end of the first rod-shaped portion is connected to the first central member, the other end of the first rod-shaped portion is connected to the first leaf-shaped portion, the first rod-shaped portion is bent to the predetermined angle, and the cross-sectional shape of the first leaf-shaped portion is an arc shape;

each second flap comprises a second leaf part and a second rod-shaped part, one end of the second rod-shaped part is connected with the second central piece, the other end of the second rod-shaped part is connected with the second leaf part, the second rod-shaped part is bent to the preset angle, and the cross section of the second leaf part is arc-shaped.

Preferably, the predetermined angle is 100-120 degrees.

Preferably, the predetermined angle is 110 degrees.

Preferably, two notches are respectively opened on two opposite side surfaces of the cylindrical part, and the notches are formed to be recessed from one end of the cylindrical part to the other end.

Preferably, the mitral valve clip further includes a control portion that is fixed to the cylindrical portion, and the control portion is connected to the first center piece and the second center piece, respectively, and controls sliding of the first center piece and the second center piece.

Preferably, the control portion includes a control tube and two control rods, the two control rods are located in the control tube, the control tube is fixedly connected to the cylindrical portion, and the two control rods are respectively connected to the first center piece and the second center piece and control sliding of the first center piece and the second center piece.

The positive progress effects of the invention are as follows: the mitral valve clamp can be passed through a catheter into the heart and clamp the normally unoccluded mitral valve by creating a clamp between the first flap and the second flap, thereby preventing mitral regurgitation.

Drawings

FIG. 1 is a front view of a mitral valve clip according to an embodiment of the present invention;

FIG. 2 is a front view of a mitral valve clip according to an embodiment of the present invention, wherein the second flap is open;

FIG. 3 is a schematic front view of a mitral valve clip according to an embodiment of the present invention, wherein the first flap and the second flap are both open;

fig. 4 is a front view of the mitral valve clip of fig. 2 with the cylindrical portion removed.

Detailed Description

The present invention is further illustrated by way of example and not by way of limitation in the scope of the described embodiments in connection with the accompanying drawings.

As shown in fig. 1-4, mitral valve clip 10 comprises: two first sheets 11, two second sheets 12, a central portion and a cylindrical portion 15.

The central part comprises a first central part 13 and a second central part 14 sleeved outside the first central part 13, a cylindrical part 15 is sleeved on the second central part 14, the first central part 13 can slide relative to the second central part 14, and the second central part 14 can slide relative to the cylindrical part 15.

Two notches 151 are opened in opposite side surfaces of the cylindrical portion 15, respectively, and the notches 151 are formed to be recessed from one end of the cylindrical portion 15 toward the other end.

The first sheet 11 and the second sheet 12 are each an elastic member bent at a predetermined angle; one end of each of the two first flaps 11 is connected to a first central piece 13 and one end of each of the two second flaps 12 is connected to a second central piece 14.

The two first flaps 11 can be simultaneously opened and simultaneously closed with respect to the first central member 13, and the two second flaps 12 can be simultaneously opened and simultaneously closed with respect to the second central member 14. When both first and

second flaps

11, 12 are open, both first flaps 11 are in the same direction as both second flaps 12 and the first flaps 11 form a grip with the second flaps 12.

The first and

second flaps

11, 12 are preferably both thermoformed members.

Each of the first sheets 11 includes a first leaf portion 111 and a first rod portion 112, one end of the first rod portion 112 is connected to the first central member 13, the other end of the first rod portion 112 is connected to the first leaf portion 111, the first rod portion is bent at a predetermined angle, and the cross-sectional shape of the first leaf portion 111 is arc-shaped. The predetermined angle is preferably 100-120 degrees, more preferably 110 degrees, to better conform to the upper surface of the mitral valve.

Each second flap 12 includes a second leaf 121 and a second rod 122, one end of the second rod 122 is connected to the second central element 14, the other end of the second rod 122 is connected to the second leaf 121, the second rod is bent at a predetermined angle, and the cross-sectional shape of the second leaf 121 is arc-shaped. As shown in fig. 4, the predetermined angle R is preferably 100 degrees and 120 degrees, and more preferably 110 degrees, to better conform to the inferior surface of the mitral valve.

The mitral valve clip 10 further includes a control portion that is fixed to the cylindrical portion 15, is connected to the first and

second centerpieces

13 and 14, respectively, and controls sliding of the first and

second centerpieces

13 and 14. The control portion comprises a control tube in which two control rods are located, the control tube being fixed to the cylindrical portion 15, and two control rods connected to the first and

second centerpieces

13 and 14, respectively, and controlling the sliding of the first and

second centerpieces

13 and 14.

The surface of the first sheet 11 facing the second sheet 12 is provided with barbs. The barb structure is beneficial to better clamping the mitral valve leaflets and can not cause necrosis of the cells of the leaflets.

The surfaces of the mitral valve clip 10 are each coated with a fabric or surface treated so that the endothelial tissue can climb the surface of the mitral valve clip 10.

The material of the first and

second flaps

11, 12 is preferably nitinol. The nickel-iron alloy is a memory metal, and the first sheet 11 and the second sheet 12 are accurately bent to a predetermined angle by using the shape memory thereof.

The manner in which the mitral valve clip 10 is used is briefly described below.

The operator first makes a puncture from the left chest incision and the apex of the heart of the patient, then inserts the catheter into the left ventricle along the opening, and then sends the mitral valve clip 10 from the catheter into the left ventricle via the delivery device, from where it enters the mitral valve via ultrasound and radiation guidance. The mitral valve clip 10 is in a collapsed state in the catheter, as shown in fig. 1, with both the first flap 11 and the second flap 12 collapsed in the cylindrical portion 15. After the mitral valve clip 10 enters the left ventricle, the sliding of the first and

second centerpieces

13, 14 is controlled by the control portion. First, the second core member 14 is slid upward until the bent portion of the second sheet 12 is disengaged from the cylindrical portion 15, and the second sheet 12 is opened, as shown in fig. 2. The upper surface of the second flap 12 is then caused to conform to the lower surface of the mitral valve. Then, the control unit controls the first centering element 13 to slide upward until the bending portion of the first sheet 11 is separated from the second centering element 14, the first sheet 11 is opened, and the opened first sheet 11 forms a clamp with the second sheet 12 therebelow, as shown in fig. 3, so as to clamp the two leaflets of the mitral valve, and then detects whether the mitral valve has regurgitation or has a significantly reduced regurgitation phenomenon to determine whether the mitral valve clamp 10 is clamped in the correct position. If it is judged that the mitral valve clip 10 has been clipped in the correct position, the first and

second center pieces

13 and 14 are controlled to slide downward so that the first and

second sheets

11 and 12 are re-gathered into the cylindrical portion 15 and the leaflets held by both are also firmly clipped in the mitral valve clip 10 through the notches 151 of the cylindrical portion 15.

After this, the mitral valve clip 10 is disengaged from the delivery device, which is then withdrawn from the left ventricle and the patient's apex puncture site and left chest incision are sutured.

The invention has shorter path through interventional operation, is easier to operate in the operation, can accurately find the proper clamping position of the mitral valve, has shorter operation time and higher operation success rate.

In the description of the present invention, it is to be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.

While specific embodiments of the invention have been described above, it will be appreciated by those skilled in the art that this is by way of example only, and that the scope of the invention is defined by the appended claims. Various changes and modifications to these embodiments may be made by those skilled in the art without departing from the spirit and scope of the invention, and these changes and modifications are within the scope of the invention.

Claims

1. A mitral valve clip, comprising:

two first flaps, two second flaps and a central portion;

when the two first sheets and the two second sheets are opened, the two first sheets are positioned at the same side of the two second sheets, and the first sheets and the second sheets form a clamp;

the mitral valve clamp further comprises a cylindrical part, the central part comprises a first central piece and a second central piece sleeved outside the first central piece, the cylindrical part is sleeved on the second central piece, the first central piece can slide relative to the second central piece, and the second central piece can slide relative to the cylindrical part; the first sheet-like object and the second sheet-like object are both elastic components bent into a preset angle; one end of each of the two first sheets is connected with the first central piece, and one end of each of the two second sheets is connected with the second central piece;

the first and second flaps are both thermoformed components;

two notches are respectively formed in two opposite side faces of the cylindrical portion, and the notches are formed to be recessed from one end of the cylindrical portion to the other end of the cylindrical portion.

2. The mitral valve clip of claim 1, wherein a surface of the first flap facing the second flap is provided with barbs.

3. The mitral valve clip of claim 1, wherein surfaces of the mitral valve clip are each coated with a fabric or surface treated so that endothelial tissue can climb the surface of the mitral valve clip.

4. The mitral valve clip of claim 1, wherein the material of the first and second flaps is nitinol.

5. The mitral valve clip of claim 1, wherein each of the first flaps comprises a first leaflet and a first stem, one end of the first stem being connected to the first hub and the other end of the first stem being connected to the first leaflet, the first stem being bent at the predetermined angle, the first leaflet having a cross-sectional shape that is an arc;

6. The mitral valve clip of claim 1, wherein the predetermined angle is 100 degrees and 120 degrees.

7. The mitral valve clip of claim 6, wherein the predetermined angle is 110 degrees.

8. The mitral valve clip of claim 1, further comprising a control portion secured to the cylindrical portion, the control portion being connected to and controlling sliding of the first and second centerpieces, respectively.

9. The mitral valve clamp of claim 8, wherein the control portion includes a control tube and two control rods, the two control rods being located in the control tube, the control tube being secured to the cylindrical portion, the two control rods being connected to and controlling sliding of the first and second centerpieces, respectively.