CN113274171A

CN113274171A - Heart tricuspid valve posterior leaflet replacing device and size measuring method thereof

Info

Publication number: CN113274171A
Application number: CN202110588546.3A
Authority: CN
Inventors: 邹煜
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-05-28
Filing date: 2021-05-28
Publication date: 2021-08-20

Abstract

The invention relates to a heart tricuspid valve posterior leaflet replacing device and a size measuring method thereof, which comprises a suture disc (3) and artificial leaflets (1) connected with the suture disc (3), and is characterized in that the suture disc (3) is an arc-shaped disc which completely covers the posterior valve ring and partially extends and covers the anterior valve ring and the valve separating ring, and the suture disc (3) comprises a body and a cloth layer wrapped on the body; the artificial valve leaflet (1) is connected with the sewing disc (3), the circular arc bottom edge of the artificial valve leaflet is sewn on the cloth layer of the sewing disc (3), and the tip of the vertex angle of the artificial valve leaflet (1) is sewn with an artificial chordae tendineae (4). The device does not need integral replacement, does not influence the heart conduction system and the function of the right heart, and avoids long-term anticoagulation.

Description

Heart tricuspid valve posterior leaflet replacing device and size measuring method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a device for replacing a posterior valve leaflet of a tricuspid valve of a heart under direct vision.

Background

The tricuspid valve has been the valve that is "forgotten". In tricuspid insufficiency, functional tricuspid regurgitation accounts for 90%. At present, functional tricuspid insufficiency is often caused by poor coaptation of the posterior valve leaflet and other two valve leaflets due to the enlargement of the posterior valve annulus of the tricuspid valve, and the valve annulus is usually repaired after the posterior valve leaflet is folded or the annuloplasty ring is used for reduction clinically. For the incompetent tricuspid valve only the total replacement can be performed.

However, there are a number of disadvantages to total tricuspid valve replacement. Firstly, the overall replacement valve can damage the overall structure of the right heart, chordae tendineae, papillary muscles and valve leaflets and influence the function of the right heart; and the artificial valve adopts a rigid valve ring, the effective functional area is limited, the blood flow area of the natural valve cannot be reached, the postoperative relative stenosis is caused, the pressure of the right heart system is low, the blood flow is slow, the artificial valve is easy to form thrombus, the complications such as pulmonary embolism and the like are caused, and the long-term effect is poor. Secondly, the tricuspid valve is easy to damage atrioventricular node or conduction bundle during replacement, which causes conduction block, and an artificial pacemaker needs to be installed, thus affecting the life quality of patients. Thirdly, if the artificial mechanical valve is replaced, and if the pacemaker is installed in the later stage, the heart can only be installed in an epicardial type by opening the chest, and the wound is large. In summary, there is uncertainty in the efficacy of treatment and the above-mentioned risks following total replacement of the tricuspid valve.

Disclosure of Invention

In order to overcome the defects that thrombus is easy to form after the tricuspid valve is integrally replaced, conduction block is caused, right heart function is influenced, and the functional area is relatively small in the prior art, the invention provides the device for replacing the posterior valve leaflet of the heart tricuspid valve under direct vision, which has good effective functional area, does not need integral replacement, does not influence the heart conduction system and the right heart function, and avoids long-term anticoagulation.

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

the heart tricuspid valve posterior leaflet replacement device comprises a suture disc (3) and a prosthetic leaflet (1) connected with the suture disc (3), and is characterized in that the suture disc (3) is an arc disc which completely covers the posterior valve ring and partially extends to cover the anterior valve ring and the valve separating ring, and the suture disc (3) comprises a body and a cloth layer wrapped on the body; the artificial valve leaflet (1) is in a fan shape and is connected with the front valve, the separating valve and the sewing disc (3), the circular arc bottom edge of the artificial valve leaflet is sewn on the cloth layer of the sewing disc (3), and the tip of the vertex angle of the artificial valve leaflet (1) is sewn with an artificial chordae tendineae (4).

Preferably, the arc shape of the suture disc (3) is a semi-ellipse or a semi-circle in the same plane.

Preferably, the suture disc (3) is 1 mm-1.8 mm thick and 4 mm-6 mm wide.

Preferably, the suture disc (3) is 1.5mm thick and 5mm wide.

Preferably, the artificial valve leaflet adopts an artificial bovine pericardial valve.

Preferably, the cloth layer is polyester fabric.

Preferably, the suture tray 10 is semi-elliptical or semi-circular in the same plane.

Preferably, the suture disk 10 body is made of a rigid titanium alloy.

The invention also provides a device for replacing the posterior valve leaflet of the heart tricuspid valve and a size measuring method thereof, which are used for measuring the length of a semi-circumference a at the outer side of the tricuspid valve ring, the length b of the posterior valve ring from the anterior-posterior boundary of the tricuspid valve to the posterior septal boundary and the distance c from the midpoint of the posterior valve ring to the closing boundary point of the tricuspid valve; the circumferential size of the suture disc is determined according to the length of the circumferential diameter a, and the sector area and the length of each side of the artificial valve leaflet are determined according to the length b and the distance c of the posterior valve annulus.

Therefore, the invention has the following beneficial effects:

1. the device has the functions of annulus suturing and leaflet replacing when in use, thereby greatly improving the treatment effect of tricuspid valve regurgitation.

2. When the device is implemented, the device is sutured on the valve ring at the outer side of the tricuspid valve, and is far away from the dangerous triangle of the atrioventricular node and conduction bundle, so that atrioventricular conduction block cannot be caused, and the possibility of installing an artificial pacemaker is avoided.

3. After the device is implemented, the anticoagulation of mechanical valve replacement for the whole life is not needed, and the occurrence of thrombus is avoided. Because the artificial valve is only used for replacing the back valve when the device is implemented, the front valve, the septal valve and the original back valve are reserved, and the three-dimensional structures of the valve, the chordae tendineae and the papillary muscles are maintained, the function of the right heart is not influenced; when the device is implemented, the effective functional area of the blood flow is equivalent to that of a natural valve, which is far larger than that of artificial valve replacement, and the long-term curative effect is good.

Drawings

Fig. 1 is a schematic structural diagram of a device for replacing a tricuspid valve posterior leaflet of a heart according to an embodiment of the present application.

Fig. 2 is a schematic view of the heart of fig. 1 with a posterior tricuspid leaflet replacement device sutured at the annulus outside the tricuspid valve.

Fig. 3 is a coronal cross-sectional view of an implementation of a cardiac tricuspid valve posterior leaflet replacement device.

Fig. 4 is a schematic diagram of the artificial chordae tendineae and papillary muscle connection of the heart tricuspid valve posterior leaflet replacement device.

Fig. 5 shows three lengths of the model selection of the heart tricuspid valve posterior leaflet replacement device, which need to be measured.

In the figure:

1 artificial valve leaf; 2, artificial valve ring; 3, sewing a disc; 4 artificial chordae tendineae; 5 papillary muscles; 6 coronary sinus venosus.

Detailed Description

The invention is further described with reference to the following figures and detailed description.

The present application relates to the field of tricuspid valve regurgitation surgery. According to some embodiments of the present application, the devices disclosed herein replace the function of the native tricuspid valve posterior leaflet structure, thereby restoring right heart function and/or reversing the pathophysiology associated with severe tricuspid valve regurgitation.

The device is deployed under the direct vision supported by the extracorporeal circulation of a surgeon. Is suitable for patients who have tricuspid valve insufficiency caused by the expansion of tricuspid valve annulus or the contracture of the posterior valve or the rupture of chordae tendineae and can not carry out repair and shaping. Can avoid the disadvantages caused by the overall replacement of the tricuspid valve, improve the symptoms of the patient (main purpose) and obtain good long-term effect (possible concomitant benefits).

Fig. 1 and 2 respectively show a structure of a heart tricuspid valve posterior leaflet replacement device according to an embodiment of the application and a schematic view of the heart tricuspid valve posterior leaflet replacement device sutured at the annulus outside the tricuspid valve. As shown, the heart tricuspid valve posterior leaflet replacement device, which is implanted by a surgical method to replace the posterior leaflet in the tricuspid valve, includes a suture disc 3 and an artificial leaflet 1 attached to the suture disc 3.

The suture disc 3 is sized to fit the annulus of the posterior tricuspid leaflet of a human patient, i.e., an arcuate disc that completely covers the posterior annulus and extends partially over the anterior and septal annuli. In some embodiments, the suture tray 10 may be semi-elliptical or other semi-circular. The suture tray 10 is planar. The sewing disk 10 includes a body and a polyester fabric wrapped on the body. The artificial valve leaflet adopts an artificial bovine pericardial valve, is cut into a triangular shape with a proper size and connected with the sewing disc, and is then artificially sewn on the terylene cloth of the sewing disc 3.

In one embodiment, the suture disc 3 is preformed, shaped to have a body size, thickness (gauge), and material of the following specifications: the thickness is 1 mm-1.8 mm, the width is 4 mm-6 mm, the thickness is 1.2mm and the width is 5 mm.

In normal individuals, the circumference of the tricuspid annulus is, for example, about 120mm, and the average diameter of a normal individual may be 28 ± 5 mm. In individuals with tricuspid regurgitation, the circumference may be 140mm-150mm or more and the average diameter of the tricuspid annulus may be >40 mm.

In some embodiments, the suture disc 3 body may have different length half-arcs for different sizes of tricuspid rings. In some embodiments, the suture disk 3 may have a circumference of 30mm to 88mm, a semi-circular arc having a central angle of 100 degrees to 190 degrees, and a preferred embodiment employs a 185 degree suture disk.

The suture disc 3 is made of a rigid titanium alloy.

Referring to fig. 4, in the embodiment, the artificial leaflet 1 has a triangular shape, the base of which is sewn on the sewing disc 3, the tip of the artificial leaflet 1 needs to be sewn with the artificial chordae tendineae 4 after the integrated device is fixed on the valve annulus, the other end of the artificial chordae tendineae is sewn on the papillary muscle 5 suitable for the right ventricle of the heart, and the chordae tendineae length is repeatedly adjusted until the two leaflets are well jointed.

Before surgery, cardiovascular imaging (e.g., Computed Tomography (CT), cardiac Magnetic Resonance Imaging (MRI), and ultrasound examination) may be performed to determine the suitability of the patient's cardiac anatomy and to understand the tricuspid annulus, posterior leaflet size, and shape.

The size of the artificial valve leaflet and the circumferential dimension of the suture disc need to be matched with the data of a patient, so that in the extracorporeal circulation surgery, the length of a half circumferential diameter a of the outer side of the tricuspid annulus of the patient is measured visually, the length b of the posterior valve annulus of the anterior-posterior junction of the tricuspid valve to the posterior septum junction of the tricuspid valve and the distance c from the midpoint of the posterior valve annulus to the junction of the three-valve-closed junction of the tricuspid valve are measured visually as shown in fig. 5. The circumferential size of the suture disc is determined according to the length of the circumferential diameter a, and the sector area and the length of each side of the artificial valve leaflet are determined according to the length b and the distance c of the posterior valve annulus.

Then the suture disc 3 of the device is sutured with the annulus at the outer side of the tricuspid valve by intermittent mattress suture, the artificial chordae tendineae are sutured at the appropriate papillary muscle of the right ventricle in a shape like a Chinese character '8', and the other end of the artificial chordae tendineae 4 is fixed at the tip of the artificial valve leaflet 1. Then, the closing conditions of the artificial valve leaflets and the self anterior valve and the septal valve are checked through a right chamber water injection test, the length of the artificial chordae tendineae is continuously adjusted until the closure is good, and the artificial chordae tendineae are knotted and fixed.

Claims

1. A heart tricuspid valve posterior leaflet replacement device comprises a suture disc (3) and a prosthetic leaflet (1) connected with the suture disc (3), and is characterized in that the suture disc (3) is an arc disc which completely covers the posterior valve ring and partially extends to cover the anterior valve ring and the septal valve ring, and the suture disc (3) comprises a body and a cloth layer wrapped on the body; the artificial valve leaflet (1) is connected with the sewing disc (3), the circular arc bottom edge of the artificial valve leaflet is sewn on the cloth layer of the sewing disc (3), and the tip of the vertex angle of the artificial valve leaflet (1) is sewn with an artificial chordae tendineae (4).

2. The device for replacing the tricuspid valve posterior leaflet of the heart according to claim 1, wherein the arc shape of the suture disc (3) is a semi-ellipse or a semi-circle in the same plane.

3. The device for replacing the tricuspid valve posterior leaflet of the heart according to claim 2, wherein the suture disc (3) has a thickness of 1mm to 1.8mm and a width of 4mm to 6 mm.

4. A device according to claim 3, characterized in that said suture disc (3) has a thickness of 1.5mm and a width of 5 mm.

5. The heart tricuspid valve posterior leaflet replacement device according to claim 2, wherein the circumference of the semi-elliptical or semicircular suture disc (3) ranges from 30mm to 88mm, and the central angle of the circular arc ranges from 100 degrees to 190 degrees.

6. The heart tricuspid valve posterior leaflet replacement device according to claim 1, characterized in that the suture disc (3) body is made of a rigid titanium alloy material.

7. The device for replacing the tricuspid valve posterior leaflet of the heart as claimed in claim 1, wherein the artificial leaflet is a bovine pericardial artificial valve.

8. The device according to claim 1, wherein the cloth layer is polyester cloth.

9. The method of any one of claims 1-9, wherein the method comprises measuring the length of a circumferential radius (a) outside the tricuspid annulus, the length of the posterior valve annulus from the anterior-posterior junction to the posterior septal junction of the tricuspid valve, and the distance (c) from the midpoint of the posterior valve annulus to the junction of the tricuspid valve and the valve closure; the circumferential size of the suture disc is determined according to the length of the circumferential diameter (a), and the sector area and the length of each side of the artificial valve leaflet are determined according to the length (b) and the distance (c) of the posterior valve annulus.