CN111329622A

CN111329622A - Intervention type artificial heart valve

Info

Publication number: CN111329622A
Application number: CN202010148505.8A
Authority: CN
Inventors: 金杰
Original assignee: Hangzhou Jinhangqi Medical Technology Co ltd
Current assignee: Hangzhou Jinhangqi Medical Technology Co ltd
Priority date: 2020-03-05
Filing date: 2020-03-05
Publication date: 2020-06-26
Anticipated expiration: 2040-03-05
Also published as: CN111329622B

Abstract

The invention relates to the technical field of medical instruments, in particular to an intervention type artificial heart valve. The artificial heart valve comprises a valve support, valve leaflets, valve leaflet traction ropes and a valve leaflet anchoring support, wherein the valve leaflets are unileaflet valves; one part of the valve leaflet is connected with the lower part of the valve stent, and the other part of the valve leaflet is connected with the valve leaflet anchoring frame through the valve leaflet traction cable; the leaflet anchor frame is connected to a valve stent. The artificial heart valve can better avoid the perivalvular leakage and the obstruction of the left ventricular outflow tract by the redundant covering of the valve leaves.

Description

Intervention type artificial heart valve

Technical Field

The invention relates to the technical field of medical instruments, in particular to an intervention type artificial heart valve.

Background

The heart is one of the most important organs of the human body and provides power for the blood circulation of the human body. The human normal heart has four cavities, namely a left atrium and a right atrium and a left ventricle and a right ventricle, wherein the left atrium is communicated with the left ventricle, and the right atrium is communicated with the right ventricle. A valve is arranged between the atria and the ventricles to prevent the backflow of blood. The valve between the left atrium and the left ventricle is the mitral valve, and the valve between the right atrium and the right ventricle is the tricuspid valve.

The mitral valve is located between the left atrium and the left ventricle and acts as a one-way valve to ensure that blood flows from the left atrium into the left ventricle during diastole and does not regurgitate during systole. The tricuspid valve functions in the same way. If the mitral valve becomes diseased, mitral regurgitation, i.e., the flow of blood from the left ventricle back into the left atrium, can occur. Tricuspid regurgitation is treated in the same way. Mitral regurgitation is generally common and has serious consequences in the clinic, and the following text is mainly directed to the mitral valve. The annulus, leaflets and their associated chordae tendineae and papillary muscles of the mitral valve are closely related in function and structure and are referred to as the mitral valve complex. When the normal mitral valve is closed, the two valve leaflets are in the same plane and are tightly closed, so that the backflow of ventricular blood can be completely prevented. Abnormalities in any portion of the mitral valve complex can lead to untight closure of the mitral valve and regurgitation. And because the left ventricular pressure is extremely high, and the peak can reach a pressure of about 16 kilopascals (120mmHg), the mitral valve is slightly loose, and more regurgitation can occur.

The causes of mitral regurgitation typically include mitral valve degeneration, calcification, rheumatic heart disease, papillary muscle injury due to myocardial ischemia, infective endocarditis, and the like. Among them, the factors of mitral valve degeneration, calcification, ischemic injury caused by myocardial infarction, etc. are closely related to age factors. With the increasing aging, the proportion of patients with mitral regurgitation in the population is increasing. It is a conservative estimate that mitral regurgitation is present in about 10% of the population over the age of 75 in the united states. Degenerative mitral valve disease usually further worsens as the patient ages, requiring surgical intervention. However, the traditional surgical treatment needs to be completed by technologies such as extracorporeal circulation and cardiac arrest, and the operation trauma is large, the operation time is long, and the complications are many, so that the operation risk of many elderly patients or patients with other chronic diseases is extremely high.

In recent years, transcatheter heart valve replacement has advanced rapidly with the development of interventional techniques. The transcatheter aortic valve replacement (TAVI) is mature day by day, the operation process has no extracorporeal circulation, the heart does not stop beating, the minimally invasive incision is made, the operation time is short, the wound is small, and the postoperative recovery is fast. In the european and american countries, TAVI has become one of the preferred surgical options for high-risk patients.

Transcatheter mitral valve replacement (TMVI/TMVR) is also under active development. However, current research is still faced with many challenges, subject to the anatomical features of the mitral valve complex. The mitral valve complex is complex in structure, firstly the mitral valve annulus is non-circular and more close to a D shape; the structures of chordae tendineae and papillary muscles below the mitral valve are complex; the mitral blood flow passage is short, without the typical tubular area; the mitral annulus size changes with systolic relaxation. Due to the above characteristics, the following difficulties are encountered when the intervention type artificial valve is placed in the mitral valve position: the bracket is difficult to fix; perivalvular leakage is easy to occur; it is easy to cause obstruction of left ventricular outflow tract. Because of the high pressure and importance of the left ventricle, any of these several problems can occur as a life-threatening complication to the patient.

At the same time, the solutions to these several problems are often contradictory. For example, to prevent paravalvular leakage, the circumference of the valve stent needs to be large enough to fit tightly against the native valve annulus to eliminate or reduce the occurrence of paravalvular leakage; however, an oversized stent can encroach on the space of the left ventricular outflow tract, which is likely to cause obstruction of the left ventricular outflow tract.

Disclosure of Invention

Technical problem to be solved

To solve the above problems of the prior art, the present invention provides an interventional prosthetic heart valve.

(II) technical scheme

In order to achieve the purpose, the invention adopts the main technical scheme that:

an interventional artificial heart valve comprises a valve bracket, valve leaflets, valve leaflet traction cables and a valve leaflet anchoring bracket; the valve leaflet is a single-leaf valve; one part of the valve leaflet is connected with the lower part of the valve stent, and the other part of the valve leaflet is connected with the valve leaflet anchoring frame through the valve leaflet traction cable; the leaflet anchor frame is connected to a valve stent.

According to the invention, the atrial surface opening area of the valve support is larger than the ventricular surface opening area, and the area of the valve leaflet is larger than the ventricular surface opening area of the valve support.

According to the invention, the valve leaflets can redundantly cover the valve stent ventricular face openings in the closed state.

According to the invention, the ventricular-surface opening of the valve support is folded outwards.

According to the invention, the leaflet traction cords are made of a soft material for limiting the hyperextension of the leaflets.

According to the invention, the leaflet anchor frame is provided with a stop lever for stopping the leaflets.

According to the invention, the leaflet anchor frame comprises an open end fixedly connected to the valve support frame and a closed end connected to a plurality of leaflet pull cords.

According to the present invention, the closed end of the leaflet anchor frame extends in the ventricular direction.

According to the invention, the valve support is provided with barbs, and the free ends of the barbs extend towards the direction of the atrium face opening of the valve support.

According to the invention, the valve stent is a net structure consisting of a plurality of diamond-shaped stent units.

According to the invention, the valve stent is approximately D-shaped in the fully deployed state.

(III) advantageous effects

The invention has the beneficial effects that: the valve leaflet of the intervention type artificial heart valve adopts the single-leaflet valve, and because the area of the single-leaflet valve is larger than the opening area of the ventricle surface of the valve support, the single-leaflet valve can redundantly cover the gap between the valve support and the native mitral valve annulus, so that the valve can be well prevented from leaking around the valve. Meanwhile, the circumference of the valve stent is not required to be too large, and the invasion to the left ventricular outflow tract is reduced.

Drawings

FIG. 1 is a top view of an interventional prosthetic heart valve of the present invention in a valve closed state;

FIG. 2 is a top view of an interventional prosthetic heart valve of the present invention in a valve open state;

fig. 3 is a perspective top view of a valve in a closed state according to example 1 of the present invention;

fig. 4 is a bottom perspective view of a closed valve provided in example 1 of the present invention;

fig. 5 is a perspective top view of the valve in an open state according to example 1 of the present invention;

fig. 6 is a bottom perspective view of the valve in an open state, provided in example 1 of the present invention;

fig. 7 is a top perspective view of a valve in a closed state according to example 2 of the present invention;

fig. 8 is a perspective top view of the valve in an open state according to example 2 of the present invention.

[ description of reference ]

1: a valve stent; 2: a leaflet; 3: a leaflet extension cord; 4: a leaflet anchoring frame; 5: an atrial face opening; 6: a ventricular face opening; 7 stop lever.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiment is only one embodiment of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the scope of the present invention.

Example 1:

as shown in fig. 1-6, the present invention provides an interventional prosthetic heart valve, which is mainly applied to a transcatheter mitral valve or tricuspid valve implantation and replacement operation. Comprises a valve bracket 1, valve blades 2, valve blade traction ropes 3 and a valve blade anchoring bracket 4; the valve leaflet 2 is a single-leaf valve; one part of the valve leaflet 2 is fixed at the lower part of the valve stent 1, and the other part is connected to the valve leaflet anchoring frame 4 through the valve leaflet traction cable 3; the leaflet anchor frame 4 is fixedly connected with the valve stent 1.

As can be seen from fig. 1 and 2, the valve stent 1 of the present invention is approximately D-shaped in the fully deployed state; closer to a D-shape due to the non-circular shape of the mitral annulus; the valve stent 1 of the present invention can better conform to the native mitral annulus.

As can be seen from fig. 3 and 4, the upper opening of the valve support 1 is large, and when the artificial heart valve is placed in the heart, the opening faces the atrial surface, and is the entrance of blood flow, namely, the atrial surface opening 5 in the invention; blood flows through this opening from the atrium into the ventricle; the lower opening of the valve support 1 is smaller, and when the artificial heart valve is placed in the heart, the opening faces to the ventricular surface and is an outlet of blood flow, namely the ventricular surface opening 6. The valve support 1 is gradually reduced from the atrial face opening 5 to the ventricular face opening 6, and then is folded outwards at the ventricular face opening 6, and the structure can play a certain fixing role to help the valve support 1 to clamp the mitral valve annulus. The valve stent 1 is composed of a plurality of diamond-shaped stent units and is easily compressed and placed into a delivery system. The valve leaflet 2 is in a closed state, and the valve leaflet 2 is larger in area than the lower opening of the valve support 1, and the valve leaflet 2 completely covers the lower opening of the valve support 1 and has redundancy.

Referring to fig. 4, this view more clearly shows the leaflets 2 completely covering the lower opening of the valve stent 1; one part of the edge of the valve leaflet 2 and the straight line part of the D shape of the valve support 1 can be connected through sewing, the other part of the edge of the valve leaflet 2 is a free edge, and the free edge is not connected with the valve support 1; the free edge of the valve leaflet 2 is connected with a valve leaflet anchoring frame 4 through a valve leaflet traction cable 3; one end of the valve leaflet traction cable 3 is connected with the valve leaflet 2 through sewing, and the other end of the valve leaflet traction cable 3 is connected with the valve leaflet anchoring frame 4 through sewing. When the leaflets 2 close, the leaflet traction cords 3 are taut, limiting the leaflet 2 from over-extending. The leaflet anchor frame 4 is at an oblique angle relative to the longitudinal axis of the valve stent 1 to which one end of a leaflet traction cable 3 is attached. Still fixed being equipped with the barb on the valve support 1, the free end of barb extends to 1 atrial surface open-ended direction of valve support for fixed intervention formula artificial heart valve prevents that it from taking place to remove. The quantity of barb is a plurality of, and a plurality of barbs evenly distributed are in valve support 1's periphery. When the leaflets 2 are closed, the blood flow below the leaflets 2 cannot flow back into the space above the leaflets 2.

The valve stent 1 and the valve leaflet anchoring stent 4 are both made of nickel-titanium alloy materials; the valve leaflet 2 can be a biological material, a high molecular material or a tissue engineering material; the leaflet traction cords 3 are made of a soft material, simulating the action of natural chordae tendineae.

The leaflet anchor frame 4 has a V-shaped structure (not limited thereto, but may also have a U-shaped structure, etc.), an open end of the V-shaped structure is fixedly connected to the valve stent 1, and a closed end of the V-shaped structure extends towards the ventricle of the valve stent 1.

As can be seen from fig. 5 and 6, the leaflet 2 assumes an open state. At the beginning of diastole, the atria are filled with blood, the pressure in the ventricles is very low, even 0mmHg, the pressure in the atria is higher than the pressure in the ventricles, the valve leaflets 2 open towards the ventricles under the pressure difference, and the blood enters the ventricles from the atria, thus the valve leaflets in the state of opening in fig. 5 and fig. 6 are shown; when the blood volume in the heart chamber is continuously increased and the pressure is continuously increased, particularly when the systole begins, the pressure in the heart chamber is rapidly increased, at this time, the pressure in the heart chamber exceeds the pressure in the heart chamber, the valve leaf 2 moves towards the direction of the heart chamber, when the free edge of the valve leaf 2 is attached to the lower edge of the valve support 1, the valve leaf 2 is closed, and the state of closing the valve leaf in fig. 1 to 4 is presented. This movement allows the leaflets 2 to act as one-way valves, i.e. blood flow only from the atria into the ventricles and not back from the ventricles into the atria.

Example 2:

as shown in fig. 7 and 8, in order to prevent the leaflet 2 from passing through the leaflet anchor frame 4 when the leaflet 2 is in the open state, two stoppers 7 for stopping the leaflet 2 are provided on the leaflet anchor frame 4; one end of the stop lever 7 is connected with the closed end of the valve leaflet anchoring frame 4, the other end of the stop lever 7 is connected with the valve stent 1, and the extending direction of the stop lever 7 is the same as the direction of the valve leaflet anchoring frame 4, so that the stop lever is convenient to compress and put into a conveying system. The other structure is the same as that of embodiment 1.

It should be understood that the above description of specific embodiments of the present invention is only for the purpose of illustrating the technical lines and features of the present invention, and is intended to enable those skilled in the art to understand the contents of the present invention and to implement the present invention, but the present invention is not limited to the above specific embodiments. All changes or modifications (for example, the shape of the leaflet anchoring frame may be V-shaped/U-shaped, etc.) made within the scope of the claims of the present invention should be covered within the scope of the present invention.

Claims

1. An interventional artificial heart valve is characterized by comprising a valve bracket (1), valve leaflets (2), valve leaflet traction cables (3) and a valve leaflet anchoring bracket (4); the valve leaflet (2) is a single valve leaflet; one part of the valve leaflet (2) is connected with the lower part of the valve stent (1), and the other part of the valve leaflet (2) is connected with the valve leaflet anchoring frame (4) through the valve leaflet traction rope (3); the leaflet anchor frame (4) is connected with the valve support (1).

2. The interventional prosthetic heart valve of claim 1, wherein the valve holder (1) has an atrial face opening (5) area larger than a ventricular face opening (6) area and the valve leaflet (2) has an area larger than the ventricular face opening (6) area of the valve holder (1).

3. The interventional prosthetic heart valve according to claim 2, wherein the leaflets (2) in the closed state redundantly cover the ventricular face openings (6) of the valve holder (1).

4. The interventional prosthetic heart valve according to claim 2, wherein the valve holder (1) is folded outwards at the ventricular face opening (6).

5. The interventional prosthetic heart valve of claim 1, characterized in that the leaflet tractive lines (3) are made of soft material for limiting the hyperextension of the leaflets (2).

6. The interventional prosthetic heart valve according to claim 1, characterized in that the leaflet anchoring frame (4) is provided with a stop lever (7) for blocking the leaflets (2).

7. The interventional prosthetic heart valve according to claim 1, characterized in that the leaflet anchoring frame (4) comprises an open end fixedly connected with the valve stent (1) and a closed end connected with a number of leaflet tractive lines (3).

8. The interventional prosthetic heart valve according to claim 7, characterized in that the closed end of the leaflet anchoring frame (4) extends towards the ventricle.

9. Interventional prosthetic heart valve according to claim 1, wherein the valve holder (1) is provided with barbs, the free ends of which extend in the direction of the atrial face opening (5) of the valve holder (1).

10. The interventional prosthetic heart valve according to claim 1, wherein the valve stent (1) is a mesh structure of a plurality of diamond-shaped stent units.