KR100966101B1

KR100966101B1 - Separate Aortic Artificial Valve Leaflet andTemplate for Preparation Thereof

Info

Publication number: KR100966101B1
Application number: KR1020080012355A
Authority: KR
Inventors: 송명근
Original assignee: 주식회사 사이언씨티
Priority date: 2008-02-11
Filing date: 2008-02-11
Publication date: 2010-06-28
Also published as: KR20090086857A

Abstract

The present invention consists of a plane having four sides, three sides of the plane are made of straight lines, the other side is made of curves, and from the center of the curved surface to the center of the other side opposite to the curved surface. The length of the aortic valve disease, characterized in that 0.35 to 0.70 times the length of the other side opposite to the curved surface, the length of the two sides adjacent to the curved surface is 0.20 to 0.50 times the length of the other side opposite to the curved surface It relates to an artificial valve leaf used in. The present invention also relates to a template for manufacturing the artificial valve leaf, and more particularly, to a template consisting of a top plate, a bottom plate and a handle as necessary.

Description

Individual Aortic Artificial Valve Leaflet and Template for Preparation Thereof

The present invention relates to an artificial valve leaf which reconstructs the valve leaf used for aortic valve disease. The present invention also relates to a template for manufacturing artificial valve leaf reconstructing the valve leaf used for aortic valve disease, and more particularly, to a template consisting of a top plate, a bottom plate and a handle as necessary.

The heart has four valves that guide blood flow forward. Two of them are located in the left heart where oxygenated blood flows and the other two are located in the right heart where deoxygenated blood flows. The valve on the left is the mitral valve and the aortic valve. The valve on the right is the tricuspid valve and the pulmonary valve. The double aortic valve is located between the left ventricle and the aorta and is designed to withstand the highest pressures. Aortic valves normally consist of three leaflets, but may sometimes have two or four valves. Each valve leaf is attached to the aorta wall by the aortic annulus, and there is a space called Sinus of Valsalva between the aortic wall and the valve leaf.

In the normal case of an aortic valve consisting of three valve lobes, each valve lobe is called the left coronary lobe, right coronary lobe, and coronary lobe. This is the name given because there is a left or right coronary inlet in the valsaba, and the coronary lobe is so named because there is no coronary inlet in the valsava.

The place where the leaflet and the leaflet meet is called a commissure, so in the usual case of three leaflets, three occlusal portions are present near the aortic wall. In addition, the center of each leaf leaf is called the valve leaflet. Each valve leaf is not flat but concave in the middle when viewed from Balsaba. It is similar to the shape of a rose leaf. It is called the aortic root or root (Aortic Root), including the aortic valve, the annulus, and the wall of the aorta and the foot spatula between them. Therefore, the aortic root is trapezoidal in shape and is bordered by an aortic annulus on the lower side and an sinotubular junction on the upper side and between the aortic valve lobes. Therefore, the aortic valve begins to open due to twisting and tilting of the aortic muscle and is completely opened as the blood flows forward through the contraction of the left ventricle, and when the blood flows forward due to the relaxation of the left ventricle, the valve is controlled by the aortic pressure. Create a closed phase in which the leaves are occluded.

In order for the aortic valve to be completely closed, the diameter of the ascending aortic transition must be maintained so that the leaflets can lean against each other. Thus, aortic valve disease can be divided into the presence of only the lesion of the valve leaf itself and the lesion of the aortic root, and there are mixed lesions between the two extremes. In the early stage of the disease, there may be only lesions of the valve leaf itself, but as time goes by, the structural abutment of the surrounding aortic root is also caused. In contrast, the lesion of the aortic root may not be able to occlude the valve. have.

Single aortic valve disease can be classified as having a lesion of the valve leaf itself, which can be classified into aortic valve stenosis and aortic valve insufficiency. However, in the case of aortic root disease, all of the aortic valve lobes become obstructive, and in addition, swelling, detachment, and inflammation of the aortic root and the surrounding ascending aorta are associated with the aortic valve. It is reasonable to view it as a complex disease associated with the disease.

Therefore, in order to treat aortic valve disease, it is necessary to first determine whether it is a disease of the aortic valve or combined with the surrounding ascending aorta and the aortic root disease. In the case of only aortic valve alone, replacement with an artificial valve is a standard treatment. There are two types of prosthetic valves: mechanical and tissue valves.

In the case of using a mechanical valve, there is a problem of taking anticoagulant for life in order to prevent thrombosis, and in the case of using a tissue valve, there is a problem in that reoperation is required due to the durability of the valve. In addition, all of the prosthetic valves reduce the actual cross-sectional area of the valves and are hemodynamically disadvantageous than autologous valves.

Despite these problems, surgery to replace the prosthetic valve has become a standard in aortic valve disease because it is technically difficult to mold autologous valves. In most cases, the aortic valve is replaced with an artificial valve and the surrounding aorta is also replaced with artificial blood vessels. Indeed, for the convenience of surgery, a replacement graft in the form of a composite graft combining artificial valve and artificial blood vessel is most often used. Recently, in some cases, even though the aorta is replaced with artificial blood vessels, only the aortic valve is used as an autologous aortic valve (David's procedure). However, this method has not been able to restore the function of the aortic root. It becomes burden on. In spite of this, some efforts have been made to mold aortic valves. For example, Duran et al. Proposed methods for reconstructing the aortic valve lobe by fixing the pericardial membrane. However, this is manufactured by connecting the three aortic valve lobes as a whole. Even if there are lesions in only one or two of the valve lobes, there is a disadvantage that all of the ablation must be removed and there is a limit applicable to only aortic valve disease.

In addition, the short-term and long-term results of the surgery are very poor because the diameter of the ascending aorta is not fixed.

Comprehensive aortic root and valve surgery developed by Professor Song of Korea in order to improve the problems of the above-mentioned artificial valve replacement of the aortic valve or artificial angioplasty of the aortic root. Surgery to restore the results are showing good results. Comprehensive aortic root and valve surgery consists of three stages of size. The first step is to prevent the expansion of the aortic valve annulus, which is the base of the aortic root, and the second, to fix the size of the ascending aorta, the upper part of the aortic root, to prevent the expansion. This is the step of occlusal valves.

So far, some attempts to shape the aortic valve have not been successful because they attempt to mold only the valve leaf without considering steps 1 and 2. Song, however, has achieved tremendous success by determining the first and second stages and using the method to correct the occlusion of the valve leaflets. In other words, assuming that the aortic root is a trapezoidal cone, when the size of the upper and lower ends is determined, the size of the valve leaf in between is determined within a predetermined range, so that the appropriate size of the valve leaf can be individually selected by applying the same. . Thus, even if the valve leaflets are not three but two, the appropriate size of the individual leaflets can be determined within the mathematical range.

The present invention has been made to solve the above-mentioned problems, a template that can be produced quickly and accurately a new valve leaf that is suitable for the size of the aortic valve of the patient using a biological material that can replace the aortic valve and is produced by There is a technical problem in providing an artificial valve leaf.

In order to solve the above problems, the invention consists of a plane having four sides, three sides of the plane are made of a straight line, the other side is made of a curve, and opposite the curved surface from the center of the curved surface. The length to the center of the other side is 0.35 to 0.70 times the length of the other side facing the curved surface, the length of the two sides adjacent to the curved surface is made of 0.20 to 0.50 times the length of the other side opposite to the curved surface Provided is an artificial valve leaf used for aortic valve disease. The present invention also relates to a template for manufacturing the artificial valve leaf, and more particularly, to provide a template consisting of a top plate, a bottom plate and a handle as necessary.

As described above, the present invention provides a simple and fast time to manufacture artificial valve leaf for aortic valve to accurately and easily produce artificial valve leaf of different size in patients with various aortic valve leaf lesions in the medical industry. It can be used for aortic valve leaf reconstruction and plastic surgery.

When the aortic valve lobe with lesions is individually restored using living tissue, one of three methods can be selected according to the type of lesion.

(1) If there is a lesion in the entire leaflet, 'complete-leaflet replacement', which completely removes the leaflet and attaches a new artificial leaflet to the leaflet.

(2) In cases where there is a lesion on only part of the leaflet or a rupture of a portion of the leaflet, partial leaflet resection without partial removal of the leaflet and a new artificial leaflet is applied. extension) "

(3) If the leaflets are not thickened and move smoothly, but do not support force at the central occlusal part and only have a phenomenon of prolapse, the new leaflet leaves are not expanded to increase the area of the central occlusion. 'Simple leaflet extension'

In all cases, complete valve replacement of (1) is difficult and time consuming, and there is a relatively high risk of ruin due to the high tension on the surgical sutures, so that (2) and (3) can be used. It is convenient to use it.

The present invention relates to a template used when separately manufacturing aortic valve leaf, and there may be a difference in the resources (dimensions) of the artificial valve leaf and the template according to the surgical methods (1), (2), and (3) above. Can be. However, when integrated first, the present invention consists of a plane having four sides, three sides of the plane are made of a straight line, and the other side is made of a curve, from the center of the curved surface to the curved surface. The length of the opposite side to the center is 0.35 to 0.70 times the length of the other side facing the curved surface, and the length of the two sides adjacent to the curved surface is 0.20 to 0.50 times the length of the other side facing the curved surface. It relates to an individual artificial leaflet used for aortic valve disease, characterized in that it is provided with a curved surface and an extension portion for suture space along the outer circumferential surface of two surfaces adjacent to the curved surface.

More preferably, the invention consists of a plane having four sides, three sides of the plane being straight, the other side being curved, and opposite the curved plane from the center of the curved plane. The length to the center of the other side is 0.65 to 0.70 times the length of the other side facing the curved surface, the length of the two sides adjacent to the curved surface is made of 0.40 to 0.50 times the length of the other side facing the curved surface, It relates to a separate artificial valve leaf used in aortic valve disease, characterized in that the expansion surface for suture is provided along the outer surface of the curved surface and the two adjacent surfaces.

In addition, the present invention is composed of a plane having four sides, three sides of the plane is made of a straight line, the other side is made of a curve, the center of the other side facing the curved surface from the center of the curved surface The length up to is reduced from 0.65 to 0.70 times the length of the other side facing the curved surface by 1 to 5 mm, and the length of the two sides adjacent to the curved surface is 0.40 to 0.50 times the length of the other side facing the curved surface. It is made from 1 to 5 mm reduced, and relates to the individual artificial valve leaf used in the aortic valve disease, characterized in that the expansion surface for suture along the outer peripheral surface of the curved surface and the two adjacent surfaces.

In addition, the present invention consists of a plane having four sides, three sides of the plane is made of a straight line, the other side is made of a curve, the center of the other side facing the curved surface from the center of the curved surface The length up to is 0.35 to 0.40 times the length of the other side facing the curved surface, the length of the two sides adjacent to the curved surface is 0.20 to 0.25 times the length of the other side facing the curved surface, the curved surface and the It relates to an artificial valve leaf used in aortic valve disease, characterized in that the expansion portion for suture is provided along the outer peripheral surface of the two surfaces adjacent to the curved surface.

At this time, the length of the expanded portion of the artificial valve leaf according to the invention is preferably 1mm to 2mm.

In addition, the present invention is composed of a flat plate having four sides, the three sides of the flat plate made of a straight line, the other side is made of a curve, the center of the other side facing the curved surface from the center of the curved surface The length up to is 0.35 to 0.70 times the length of the other side opposite to the curved surface, the length of the two sides adjacent to the curved surface is 0.20 to 0.50 times the length of the other side opposite to the curved surface, the curved surface and the The present invention relates to a template for the manufacture of individual artificial valve leaf used in aortic valve disease, characterized in that it comprises an upper plate provided with an extension along the outer circumferential surface of two surfaces adjacent to the curved surface and a lower plate having the same shape as the upper plate.

More preferably, the present invention consists of a flat plate having four sides, three sides of the flat plate are straight, the other side is curved, and is opposed to the curved surface from the center of the curved surface. The length to the center of the other side is 0.65 to 0.70 times the length of the other side facing the curved surface, the length of the two sides adjacent to the curved surface is made of 0.40 to 0.50 times the length of the other side facing the curved surface, It relates to a template for manufacturing individual artificial valve leaf used in aortic valve disease, characterized in that consisting of a curved surface and the upper plate provided with an extension along the outer peripheral surface of two surfaces adjacent to the curved surface and a lower plate having the same shape as the upper plate.

In addition, the present invention is composed of a flat plate having four sides, the three sides of the flat plate made of a straight line, the other side is made of a curve, the center of the other side facing the curved surface from the center of the curved surface The length up to is reduced from 0.65 to 0.70 times the length of the other side facing the curved surface by 1 to 5 mm, and the length of two sides adjacent to the curved surface is 0.40 to 0.50 times the length of the other side facing the curved surface. It is made to reduce by 1 to 5mm, used in the aortic valve disease, characterized in that the curved surface and the upper plate with an extension along the outer peripheral surface of the two surfaces adjacent to the curved surface and the lower plate made of the same shape as the upper plate It relates to a template for producing individual artificial valve leaf.

In addition, the present invention is composed of a flat plate having four sides, the three sides of the flat plate made of a straight line, the other side is made of a curve, the center of the other side facing the curved surface from the center of the curved surface The length up to is 0.35 to 0.40 times the length of the other side facing the curved surface, the length of the two sides adjacent to the curved surface is 0.20 to 0.25 times the length of the other side facing the curved surface, the curved surface and the The present invention relates to a template for the manufacture of individual artificial valve leaf used in aortic valve disease, characterized in that it comprises an upper plate provided with an extension along the outer circumferential surface of two surfaces adjacent to the curved surface and a lower plate having the same shape as the upper plate.

At this time, the length of the extension portion of the template according to the invention is preferably 1mm to 2mm, the handle may be installed in addition to the top and bottom plate of the template.

In addition, the ratio of each length portion to the four sides of the plane is very important, especially if aortic valve replacement is performed by (1) complete valve leaf replacement, (2) partial valve leaf prolongation, and (3) simple valve. Depending on whether or not lobe extension, the ratio is as follows.

In the case of the present invention, in one embodiment, the artificial valve leaf used for complete valve leaf replacement is defined as the reference length of the length of the other side opposite to the curved plane of the plane and is opposed to the curved plane from the center of the curved plane. The length to the center of the other side is preferably 0.65 to 0.70 times of the reference length, more preferably 2/3 times, and the length of the two sides adjacent to the curved surface is 0.40 to 0.50 of the length of the other side opposite to the curved surface. It is good to consist of 2 times, more preferably 4/9 times. At this time, an extension for suture may be provided along the outer surface of the curved surface and two surfaces adjacent to the curved surface, the length of the extension is preferably 1mm to 2mm.

In another embodiment of the present invention, the artificial valve leaf used for valve leaf prolongation after partial valve leaf resection is defined as a reference length of the length of the other side opposite to the curved surface of the plane, the curved surface from the center of the curved surface. The length to the center of the other side opposite to is shortened by 1 to 5 mm at 0.65 to 0.70 times the reference length, more preferably by 3 mm at 2/3 times, and two surfaces adjacent to the curved surface. The length of is reduced from 1 to 5 mm at 0.40 to 0.50 times the length of the other side opposite to the curved surface from the center of the curved surface, and more preferably 3 to 3 mm at 4/9 times. At this time, an extension for suture may be provided along the outer surface of the curved surface and two surfaces adjacent to the curved surface, the length of the extension is preferably 1mm to 2mm.

In another embodiment of the present invention, the artificial valve leaf used for simple valve lobe extension is defined as the reference length of the length of the other side opposite to the curved plane of the plane, and the other opposite to the curved plane from the center of the curved plane. The length to the center of the side surface is preferably 0.35 to 0.40 times the reference length, more preferably 10/27 times, and the length of two surfaces adjacent to the curved surface is the length of the other side opposite to the curved surface from the center of the curved surface. Of 0.20 to 0.25 times, more preferably 2/9 times. At this time, an extension for suture may be provided along the outer circumferential surface of the curved surface and two surfaces adjacent to the curved surface, and the length of the extension is preferably 1 mm to 2 mm.

The artificial valve leaf according to the present invention can be prepared by cutting out the excess tissue out of the frame along the outer edge of the upper plate and the lower plate using a surgical scissors or knife after being disposed between the upper and lower plates of the template. The material of the artificial valve leaf according to the present invention is made of a biological material such as flat autologous pericardium fixed to glutaraldehyde, bovine pericardium, porcine aortic valve, peritoneum, pleura, or fascia.

In another embodiment of the present invention, the template for producing the artificial valve leaf used for complete valve leaf replacement is defined as the reference length of the length of the other side opposite to the curved surface of the plate, from the center of the curved surface The length to the center of the other side opposite to the curved surface is preferably 0.65 to 0.70 times the reference length, more preferably 2/3 times, and the length of the two sides adjacent to the curved surface is opposite to the curved surface. 0.40 to 0.50 times the length of, more preferably 4/9 times. At this time, an extension for suture may be provided along the outer surface of the curved surface and two surfaces adjacent to the curved surface, the length of the extension is preferably 1mm to 2mm. The lower plate according to the present invention has the same shape as the upper plate.

In another embodiment of the present invention, the template for producing the artificial valve leaf used for valve leaf prolongation after partial valve leaf resection is defined as the reference length, the length of the other side opposite to the curved surface of the plate, The length from the center of the face to the center of the other side facing the curved surface is shortened by 1 to 5 mm at 0.65 to 0.70 times the reference length, more preferably by 3 mm at 2/3 times The length of the two surfaces adjacent to the curved surface may be reduced by 1 to 5 mm from 0.40 to 0.50 times the length of the other side opposite the curved surface from the center of the curved surface, more preferably by 3 mm at 4/9 times Good to reduce At this time, an extension for suture may be provided along the outer surface of the curved surface and two surfaces adjacent to the curved surface, the length of the extension is preferably 1mm to 2mm. The lower plate according to the present invention has the same shape as the upper plate.

In another embodiment of the present invention, the template for producing the artificial valve leaf for use in simple valve leaf extension is defined as the length of the other side opposite to the curved surface of the plate as a reference length, from the center of the curved surface The length to the center of the other side opposite to the curved surface is 0.35 to 0.40 times of the reference length, more preferably 10/27 times, and the length of two surfaces adjacent to the curved surface is from the center of the curved surface to the curved surface. It is good that it consists of 0.20 to 0.25 times the length of the other side surface which opposes, More preferably, it is 2/9 times. At this time, an extension for suture may be provided along the outer surface of the curved surface and two surfaces adjacent to the curved surface, the length of the extension is preferably 1mm to 2mm. The lower plate according to the present invention has the same shape as the upper plate.

The lower plate 4 of the template according to the present invention is made of the same shape as the upper plate 2, the material of the upper plate 2 and the lower plate 4 may be used as long as it is harmless to the human body, but preferably It is preferable to use polycarbonate. In addition, the handle may be additionally installed on the upper and lower plates of the template according to the present invention.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings. However, the following description is only for explaining the present invention specifically, and is not limited to the scope of the present invention by the following description.

1 is a plan view showing a top plate and a bottom plate of the template according to the invention, Figure 2 is a plan view of a template coupled to the handle according to the invention.

As shown in Figure 1, the template for producing the artificial valve leaf according to the present invention is composed of the upper plate (2) and the lower plate (4) in a macroscopic view.

Accordingly, the present invention will be described in more detail according to the type of aortic valve leaf surgery.

(1) In the complete valve leaf replacement procedure of the first embodiment of the present invention, the upper plate 2 of the template according to the present invention consists of a flat plate 6 having four sides, and the length of each side of the flat plate 6. Is defined based on the length (a) of the other side opposite the curved surface, and the length (b) from the center of the curved surface to the center of the other side opposite the curved surface is 0.65 to 0.70 of the reference length (a). The length c of the two surfaces adjacent to the curved surface is (about 2/3) times and is 0.40 to 0.50 (about 4/9) times the length b of the other side opposite to the curved surface.

Here, the extension part 8 is formed to have a clearance length for the sealing space of the valve leaf produced during valve leaf forming along the curved surface of the plate 6 and the outer circumferential surface of two surfaces adjacent to the curved surface. 8 is formed to extend 1 mm to 2 mm along the curved surface of the flat plate 6 and the outer circumferential surface of two surfaces adjacent to the curved surface.

(2) In the postoperative procedure after partial valve leaf excision of the second embodiment, the upper plate 2 of the template according to the present invention consists of a flat plate 6 having four sides, and the length of each side of the flat plate 6 is The length (b) from the center of the curved surface to the center of the other surface opposite to the curved surface is determined based on the length (a) of the other side facing the curved surface, and is 0.65 to 0.70 times the reference length (a). Is reduced by 1 to 5 mm (about 2/3 to 1 to 5 mm), and the length (c) of two faces adjacent to the curved surface is the length of the other side opposite the curved surface from the center of the curved surface. (b) by 1 to 5 mm at 0.40 to 0.50 times (about 4/9 times to 1 to 5 mm).

(3) In the simple valve lobe extension of the third embodiment, the upper plate 2 of the template according to the present invention consists of a flat plate 6 having four sides, and the length of each side of the flat plate 6 is a curved surface. The length (b) from the center of the curved surface to the center of the other surface opposite to the curved surface is determined based on the length (a) of the other side facing the surface, and is 0.35 to 0.40 times (about) the reference length (a). 10/27 times), and the length c of the two surfaces adjacent to the curved surface is 0.20 to 0.25 times (about 2/9 times) of the length b of the other side opposite to the curved surface from the center of the curved surface.

The template according to the present invention may further include a handle 10 as necessary, the handle 10 is connected to one side of the upper plate (2) and the lower plate (4) of the template to manufacture the pericardium It serves to fix the upper plate (2) and the lower plate (4) of the template to facilitate the cutting of the piece and the plate, if the purpose can be performed, the shape may be formed in any shape, the material is It is preferable to use the same material as the upper plate 2 and the lower plate 4 of the template.

Looking at the use of the artificial valve leaf and the template according to the present invention having the above-described configuration according to the embodiment of aortic valve replacement surgery is as follows.

(1) For example, the case used for complete valve replacement is as follows.

First, before using the template according to the present invention, the size of the patient's aortic root and individual valve leaflets are determined. In adults, the shape of the normal aortic root is in the ratio of the Aortic Annulus to the diameter of the Sinotubular Junction between 1.0 and 1.2, and from the center of the Ascending Aortic Transition to the diameter of the Ascending Aortic Transition. The ratio of the distance to the center of the aortic valve annulus is a trapezoidal cone with a range of 0.8 to 1.0. Thus, in a normal adult, three valve lobes can be assumed to be evenly located within the trapezoidal cone.

For example, the individual artificial valve leaf and the method of selecting the template for manufacturing the same, when the diameter of the ascending aortic transition portion is determined to be 26mm, the length (a) of the other side opposite to the curved surface of the plate 6 26 mm, the length (b) from the center of the curved surface to the length of the other side facing the curved surface is 17.3 mm, the length of the two surfaces adjacent to the curved surface is 11.5 mm, and thus the extension 8 faces the curved surface. Except for the other side is provided along the outer peripheral surface of the other three sides are provided to extend about 1.5mm.

The template according to the present invention is preferably used in conjunction with the ascending aortic transitional molding apparatus used in the Republic of Korea Patent No. 0466839 "Aortic valve forming apparatus set and a treatment method using the same" that the present inventors have already applied for, the ascending Using a template of the same size as the size of the aortic transition can determine the size of the template without measuring the size of the patient's valve leaflets separately.

Once the size of the template has been determined, biological materials such as flat autologous pericardium, bovine pericardium, porcine aortic valve, peritoneum, pleura or fascia, fixed to glutaraldehyde, are placed between the upper and lower plates (4). After arranging, the upper plate 2 and the lower plate 4 are joined to coincide.

At this time, the combined upper plate (2) and lower plate (4) is fixed so as not to shake using the handle 10, using the scissors or knife for surgery to expand the outer edge of the upper plate (2) and lower plate (4) As a result, one individual valve leaf can be produced by cutting out excess tissue out of the frame.

In addition, depending on the person, the size of each valve leaf may be different, and in some cases innately composed of two valves, even in this case, by using a template of the appropriate size to determine the size can be an effective procedure.

The outer edge extended by the expansion part 8 provides a margin for suture at the time of the procedure, and at the time of the procedure, the aortic valve ring is located at the lowest center of the curved portion of the artificial valve leaf, which is 1/3 of the height. The ratio of the length of the closure gap of the part to the length of the closure of the artificial valve leaf is 1: 1.5, and in the straight part that is the middle 1/3 of the height, the ratio is 1: 1.2, and the top 1/3 of the height In the straight portion of the suture in a ratio of 1: 1 can change the planar pericardium into a container that can hold the volume, such as spheres can perform the function of the valve leaf without abnormality.

(2) For example, when used for extension after partial valve lobectomy, it is as follows. The marginal valve leaf is partially excised from the aortic valve ring, leaving a width of about 1-5 mm, preferably about 3 mm. Then, when manufacturing artificial valve lobe, the length (c) of the two adjacent faces of the curved surface is reduced by about 1-5 mm, preferably 3 mm, and the length of the other side facing the curved surface and the curved surface (a) is the complete valve replacement. Just like when. For example, if the diameter of the ascending aorta is determined to be 26 mm, the reference length (a) of the other side of the individual artificial valve lobe opposite to the curved surface is also 26 mm, and the template is selected to be 26. In this case, the template is modified as follows. Select a template. That is, the reference length (a) of the other side facing the curved surface is 26 mm, and the length (b) of the other side facing the curved surface is reduced by 3 mm to 14.3 mm, and the two sides adjacent to the curved surface are The length is also reduced by 3mm to 8.5mm, and thus the expansion part 8 is configured to extend about 1.5mm along the outer circumferential surface of the remaining three surfaces except for the other side facing the curved surface.

When the template size is determined, biological materials such as flat autologous pericardium, small pericardium, porcine aortic valve, peritoneum, pleura, or fascia, which are fixed to glutaraldehyde, are placed between the upper and lower plates. After placing, the upper plate (2) and the lower plate (4) are combined to match. At this time, the combined upper plate 2 and lower plate 4 are fixed so as not to shake using the handle 10 and along the outer edges of the upper plate 2 and the lower plate 4 using surgical scissors or a knife. Surplus tissue out of the frame can be cut to produce a single valve leaflet.

The outer edge extended by the dilator (8) provides a margin for suture during the procedure, which is more susceptible to suture and less susceptible to the suture due to the remaining 3 mm of remaining vasculature than complete valve lobectomy. There is an advantage.

(3) An example used in simple valve prolongation is as follows. If the valve leaves prolapse without force (Prolapse), it is sufficient to extend and reinforce the existing valve leaf without cutting the valve leaf. When manufacturing the artificial valve leaf for this purpose, the height of the curved surface only (b-c) is reduced by about 2/3, and the length (c) of the two surfaces adjacent to the curved surface is reduced to 1/2.

For example, if the diameter of the ascending aorta is determined to be 26 mm, the reference length (a) of the other side of the individual Indian valve leaf opposite to the curved surface is also 26 mm, and template 26 is selected. In this case, the template is modified as follows. Select. That is, the reference length (a) of the other side facing the curved surface is 26 mm, and the height (bc) of only the curved surface decreases by 2/3 from the center of the curved surface to the length (b) of the other side facing the curved surface, The length (c) of the two faces adjacent to the curved surface is reduced to half to 9.6 mm, and the length (c) of the two faces adjacent to the curved surface is 5.7 mm so that the extension (8) faces the curved surface. Except for the other side, it is configured to extend about 1.5mm along the outer circumferential surface of the remaining three surfaces. When the template size is determined, biological materials such as flat autopericardial pericardium, small pericardial pericardium, porcine aortic valve, peritoneum, pleura or fascia, which are fixed to glutaraldehyde, are placed between the upper plate (2) and the lower plate (4). Then combine the upper plate (2) and lower plate (4) to match. At this time, the combined upper plate 2 and lower plate 4 are fixed so as not to shake using the handle 10 and along the outer edges of the upper plate 2 and lower plate 4 using surgical scissors or a knife. Individual single leaflets can be made by cutting off excess tissue out of the frame. The outer edge extended by the extension part 8 provides a margin for suture at the time of the procedure and is thus easier to suture because the valve leaf is not excised.

As described above, those skilled in the art will understand that the present invention can be implemented in other specific forms without changing the technical spirit or essential features. Therefore, the above-described embodiments are to be understood in all respects as illustrative and not restrictive. The scope of the present invention is shown by the following claims rather than the detailed description, and all changes or modifications derived from the meaning and scope of the claims and their equivalents should be construed as being included in the scope of the present invention. do.

1 is a plan view showing an upper plate and a lower plate according to the present invention

2 is a plan view of a template coupled to the handle according to the invention,

3 is a view showing an embodiment of use of the template according to the present invention.

Claims

A plane having four sides, three sides of the plane being straight, the other side being curved, and the length from the center of the curved surface to the center of the other side opposite the curved surface 0.35 to 0.70 times the length of the other side opposite to the curved surface, the length of the two sides adjacent to the curved surface is used for aortic valve disease, characterized in that consisting of 0.20 to 0.50 times the length of the other side opposite to the curved surface Artificial valve lobe.

The method of claim 1, wherein the length from the center of the curved surface of the plane to the center of the other side opposite to the curved surface is 0.65 to 0.70 times the length of the other side opposite to the curved surface and is adjacent to the curved surface. The length of the two faces artificial valve leaf used in aortic valve disease, characterized in that 0.40 to 0.50 times the length of the other side opposite to the curved surface.

The method of claim 1, wherein the length from the center of the curved surface of the plane to the center of the other side opposite to the curved surface is reduced by 1 to 5 mm at 0.65 to 0.70 times the length of the other side opposite to the curved surface. , The length of the two surfaces adjacent to the curved surface is artificial valve leaf used in aortic valve disease, characterized in that by reducing from 0.40 to 0.50 times the length of the other side opposite to the curved surface by 1 to 5 mm.

According to claim 1, wherein the length from the center of the curved surface of the plane to the center of the other side opposite to the curved surface is 0.35 to 0.40 times the length of the other side opposite to the curved surface, two surfaces adjacent to the curved surface The length of the artificial valve leaf used in aortic valve disease, characterized in that consisting of 0.20 to 0.25 times the length of the other side opposite to the curved surface.

The artificial valve leaf according to any one of claims 1 to 4, wherein an enlarged portion is provided along a curved surface and an outer circumferential surface of two surfaces adjacent to the curved surface.

6. The artificial valve leaf used in aortic valve disease according to claim 5, wherein the length of the extension part is 1 mm to 2 mm.

A flat plate having four sides, three sides of the plate are straight, the other side is curved, and the length from the center of the curved surface to the center of the other side opposite to the curved surface is 0.35 to 0.70 times the length of the other side opposite to the curved surface, the length of the two sides adjacent to the curved surface made of the same shape as the top plate and 0.20 to 0.50 times the length of the other side opposite to the curved surface Template for manufacturing artificial valve leaf, characterized in that consisting of a lower plate.

The curved surface of claim 7, wherein the length from the center of the curved surface of the upper plate and the lower plate to the center of the other side opposite to the curved plane is 0.65 to 0.70 times the length of the other side opposite to the curved plane. And the length of the two adjacent surfaces is 0.40 to 0.50 times the length of the other side opposite to the curved surface, the template for manufacturing artificial valve leaf.

According to claim 7, wherein the length from the center of the curved surface of the upper plate and the lower plate to the center of the other side opposite to the curved surface is 1 to 5mm at 0.65 to 0.70 times the length of the other side opposite to the curved surface By reducing, the length of the two surfaces adjacent to the curved surface is a template for manufacturing artificial valve leaf, characterized in that by reducing from 0.40 to 0.50 times the length of the other side opposite to the curved surface by 1 to 5 mm.

The method of claim 7, wherein the length from the center of the curved surface of the upper plate and the lower plate to the center of the other side facing the curved surface is 0.35 to 0.40 times the length of the other side facing the curved surface, The length of the adjacent two sides is a template for manufacturing artificial valve leaf, characterized in that consisting of 0.20 to 0.25 times the length of the other side opposite to the curved surface.

The template for manufacturing artificial valve leaf according to any one of claims 7 to 10, wherein an extension part is provided along a curved surface and outer peripheral surfaces of two surfaces adjacent to the curved surface.

12. The template for manufacturing artificial valve leaf according to claim 11, wherein the length of the extension part of the upper plate and the lower plate is 1 mm to 2 mm.

12. The template for manufacturing artificial valve leaf according to claim 11, further comprising a handle which is connected to one side of the upper plate and the lower plate to hold and fix the upper plate and the lower plate.