WO2011049395A2

WO2011049395A2 - Artificial leaflet and apparatus for manufacturing the same

Info

Publication number: WO2011049395A2
Application number: PCT/KR2010/007256
Authority: WO
Inventors: 송명근
Original assignee: 주식회사 사이언씨티
Priority date: 2009-10-21
Filing date: 2010-10-21
Publication date: 2011-04-28
Also published as: KR20110043361A; KR101132376B1; WO2011049395A3

Abstract

The present invention relates to an artificial leaflet used in mitral leaflet plasty for reconstructing mitral leaflet. Also, the present invention relates to an apparatus for manufacturing the artificial leaflet. According to the present invention, the artificial leaflet used in the mitral leaflet plasty can be easily manufactured according to the size of patient's mitral leaflet, thereby enabling the heart function to be recovered and maintained by reconstruction of the mitral leaflet to be close to the original form of the mitral leaflet. Therefore, the artificial leaflet can be used in mitral leaflet plasty for reconstructing mitral leaflet in the medical industry.

Description

Artificial valve leaf and its manufacturing device

The present invention relates to an artificial valve leaf used in the anterior mitral valve for use in mitral valve leaf surgery for reconstruction of the mitral valve leaf. The present invention also relates to a manufacturing apparatus for producing the artificial valve leaf.

The heart has four types of valves that guide blood flow forward through the two sides of the heart. On the left side of the heart (the whole body) is the mitral valve located between the left atrium and the left ventricle and the aortic valve located between the left ventricle and the aorta.The two valves guide the oxygenated blood from the lungs through the left side of the heart to the aorta. Distribute to the body. On the other hand, on the right side (pulmonary), there is a tricuspid valve located between the right atrium and the right ventricle and a pulmonary valve located between the right ventricle and the pulmonary artery, and these two valves distribute deoxygenated blood from the body to the pulmonary artery through the right side of the heart and distribute it there At this point, oxygen is added again to resume circulation. The four types of heart valves described above are passive structures in that they do not consume their energy and do not have any active contractile action and are designed to be able to open and close in response to differential pressures between the atria and ventricles and the ventricles and arteries. (leaflet) '.

In particular, the mitral valve and tricuspid valve, which is provided in the ventricles and guides the flow of blood forward, are located between the atria and the ventricles, which is called the atrioventricular valve. The atrioventricular valve is based on the papilla and the papilla muscle originated in the ventricles. The crop will spread out like an umbrella to serve as a valve.

Here, the mitral valve is a valve located between the left atrium and the left ventricle. The mitral valve is located between the left atrium of the muscle and the left ventricle, and at its edge is a fibrous belt-shaped annulus, and inside it there are two leaflets called anterior and posterior lobes, two in the left ventricle. Chordae protruding from the papillary muscles of the epidermis is attached to the lower part of the valve leaflet, thereby preventing the valve leaflet from being inclined toward the left atrium due to the systolic pressure in the left ventricle. However, a disease in which the mitral valve does not open completely when the heart is expanded is called mitral stenosis, and when the heart contracts, the mitral valve is not fully closed.

The mitral stenosis is congenital or congenital after suffering from rheumatoiditis. The mitral regurgitation is caused by rheumatoid inflammation, degenerative change of the valve, ischemic disease of the myocardium, bacterial or fungal infection or rupture due to trauma. The valve leaves do not close properly or develop due to degeneration of the subvalve structure. If the function of the mitral valve is incomplete due to the above reasons, the flow of the mitral valve may be impaired, causing enlargement of the left atrium and the left ventricle, reduction of the contractile force of the heart, and disturbance of blood flow.

Thus, there are currently two methods for restoring the function of the mitral valve, which are artificial valve replacement and mitral valve surgery.

Prosthetic valve replacement is widely used as a method of excision of the mitral valve lobe through surgery and insertion of a mechanical or tissue valve in place. However, mechanical valve replacement may cause thrombosis after surgery, and there is a problem of taking anticoagulant continuously. In the case of inserting the tissue valve, there is a problem in that the durability of the tissue valve has a problem that requires a reoperation after a certain period of time. In addition, prosthetic valve replacement is a surgery that destroys the mitral valve substructure, which reduces left ventricular function and destroys pectoral muscles and papillary muscles, which contribute to maintaining the function of the ventricle.

Therefore, mitral valve repair is used to restore the opening and closing function of the mitral valve, while maintaining the mitral valve leaflet and subvalve structure. Such mitral valve repair includes lifting annuloplasty, mitral commissurotomy, and percutaneous mitral valvulotomy, which lift and fix the mitral valve ring. Mitral valve leaf surgery can be used for this purpose.

Mitral valve repair involves the complete excision of the valve leaflet and the attachment of a new artificial leaflet to the annulus of the valve, a partial resection without partial removal of the valve leaflet, followed by the attachment of a new artificial leaflet to increase the occlusal area of the valve leaflet. There is a method of attaching a new artificial leaflet to increase the occlusal area of the leaflet without cutting the leaflet.

Conventional mitral valve repair has no limitation in effectively restoring the function of the mitral valve leaflet by restoring it to a circular shape without accurate calculation of the size and shape of the mitral valve leaf.

The present invention is to provide a synthetic valve leaflet prepared in accordance with the size of the anterior mitral valve of the patient for use in mitral valve leaf surgery, a template for producing the artificial valve leaf and a method for producing the artificial valve leaf.

The present invention has an upper surface and a corresponding lower surface and a side connecting the upper surface and the lower surface, the upper surface by a distance corresponding to 0.40 to 0.60 times the length of the long axis from the long axis and one end of the long axis An artificial axis used in the anterior lobe of the mitral valve, which comprises a short axis orthogonal at a spaced apart point, the length of the short axis is 0.55 to 0.90 times the length of the long axis, and the distance from one end of the short axis to 0.35 to 0.45 times the length of the short axis. Provide lobe.

The present invention also comprises a top plate having a lower surface corresponding to the upper surface of the artificial valve leaf; And a lower plate having an upper surface corresponding to the lower surface of the upper plate.

According to the present invention, the artificial valve leaf which can be used for mitral valve leaf arthroplasty can be accurately and easily manufactured according to the size of the mitral valve of the patient, thereby restoring the heart function by reconstructing the mitral valve leaf close to the original mitral valve. And it can be maintained and can be usefully used in mitral valve leaf surgery for the reconstruction of mitral valve lobe in the medical industry.

1 is a plan view showing the artificial valve leaf used in the anterior mitral valve according to the present invention.

Figure 2 is a plan view showing the artificial valve leaf manufacturing apparatus used for the mitral valve leaflet combined with the handle according to the present invention.

Figure 3 is a view showing the use of the artificial valve leaf manufacturing apparatus used for the mitral valve anterior lobe according to the present invention.

2: first surface / 4: second surface

10: artificial valve leaf / 20: extension

30: handle / 40: artificial valve leaf manufacturing apparatus top

50: artificial valve leaf manufacturing apparatus lower plate

a: artificial valve leaf long axis / b: artificial valve leaf short

c: distance from one end of the short axis to the long axis

The present invention is the upper surface; It has a lower surface and a side connecting the upper surface and the lower surface, wherein the upper surface is orthogonal at a point spaced from the long axis and the distance corresponding to 0.40 to 0.60 times the length of the long axis from one end of the long axis It includes a short axis, the length of the short axis is 0.55 to 0.90 times the length of the long axis, the distance from one end of the long axis to 0.35 to 0.45 times the length of the short axis to provide an artificial valve leaf used in the anterior mitral valve.

The artificial valve leaf is manufactured according to the shape of the anterior mitral valve of the mitral valve. The artificial valve leaf can be restored close to the original shape of the anterior mitral valve of the patient, which is useful for restoring the function through the reconstruction of the mitral valve leaf.

As used herein, the "top surface", "bottom surface" and "side surface" are terms used to describe the artificial valvular leaf formed in a planar shape, and the "top surface" refers to the upper surface of the artificial valvular leaf and the "bottom surface". Means the bottom of the artificial leaflet, and the "side" means the side of the artificial leaflet, that is, the thickness. The shape of the bottom surface corresponds to the shape of the top surface, and the term "corresponding" as used herein refers to a state in which the shapes of the two surfaces can be superimposed and overlapped. "Long axis" means the longest axis that forms the upper surface of the artificial valve leaf, and "short axis" is the longest axis orthogonal to the long axis and is 0.4 to 0.6 times the length of the long axis from one end of the long axis. It means the axis perpendicular to the long axis at the spaced point.

The height of the side surface of the artificial valve leaf according to the present invention is determined by the material of the artificial valve leaf as the thickness of the membrane and is not necessarily specified to implement the effects of the present invention. For example, the thickness of the membrane is based on the thickness of autologous pericardium, allocardial pericardium, small pericardium, porcine heart valve, peritoneum, pleura, or fascia, but is not limited thereto, and may be 0.05 to 1.5 mm, preferably 0.05. To 1.0 mm, more preferably 0.05 to 0.5 mm.

According to one embodiment of the invention, the short axis may be orthogonal to the long axis at a distance spaced from a distance corresponding to 0.45 to 0.55 times the length of the long axis from one end of the long axis, preferably the length of the long axis from one end of the long axis. It can be orthogonal to the long axis at the center of the long axis, that is, at a distance equal to 0.5 times.

According to another embodiment of the present invention, the length of the short axis may be 0.55 to 0.85 times, 0.55 to 0.80 times, 0.55 to 0.75 times, 0.55 to 0.70 times, and 0.5 to 0.65 times the length of the long axis. It may be doubled, and may be 0.55 to 0.60 times. The artificial valve leaf according to the present invention may be used after cutting not only a part of the anterior mitral valve but also the whole part, and when cutting a part, the length of the short axis is 0.55 to 0.65 times or 0.55 to 0.60 times the length of the long axis. It is preferable.

According to another embodiment of the present invention, the length from one end of the short axis to the long axis may be 0.36 to 0.44 times the length of the short axis, preferably 0.37 to 0.43 times, more preferably 0.38 to 0.42 times More preferably 0.39 to 0.41 times.

In one embodiment of the present invention, the side surface of the artificial valve leaf may be made of at least one surface selected from the group consisting of curved surfaces and planes along the circumference of the upper surface and the lower surface. For example, the side surface of the artificial valve leaf can be made to form an oval shape of the upper surface and the lower surface of the artificial valve leaf as a whole of one curved surface along the circumference of the upper surface and the lower surface. Alternatively, the curvature radius may be formed of a plurality of curved surfaces, and a plurality of curved surfaces and planes may be connected to each other to form a side surface. According to a preferred embodiment of the present invention, the side surface of the artificial valve leaf is not limited thereto, but may be formed by two curved surfaces having different radii of curvature contacting at both ends of the long axis.

In another embodiment of the present invention, the length of the long axis may be 0.7 to 0.8 times the diameter of the mitral valve. According to the length of the mitral valve length of the target patient who wants to undergo mitral valve prolongation, the length of the long axis of the artificial valve leaf can be determined and the size and shape of the overall valve leaflet can be determined. By accurately preparing and applying artificial valve lobes that conform to the shape, the function of the mitral valve can be effectively restored by restoring the patient's original mitral valve locus.

As used herein, the term "mitral valve diameter" refers to the length of the major axis of the inner diameter of the mitral valve, that is, the length of the longest axis of the inner diameter of the mitral valve, which can be determined in the form of an ellipse. Means. At this time, the size of the mitral valve diameter is not limited thereto, but may be 20 to 44 mm.

In another embodiment of the present invention, the artificial valve leaf used in the mitral valve anterior lobe may have an extension along the outer circumferential surface of the upper and lower surfaces. The extension portion is a margin for suturing the artificial valve leaf to the mitral valve leaf, specifically, the width of the expansion portion may be 1.0 mm to 2.0 mm. The extension part provides a margin for suturing the remaining valve tissue and artificial valve leaflet of the anterior mitral valve, which is easy to suture and takes less tension in the suture.

In another embodiment of the present invention, the artificial valve leaf may be made of a biological material or biocompatible material harmless to the human body. As used herein, the term "biological substance" refers to an animal film derived from animals such as humans, cows, pigs, and the like, and the term "biocompatible substance" refers to a substance having a property that does not change its physical properties in the blood for a long time. it means. Specifically, the biological material may be, but is not limited to, autologous pericardium, allocardial pericardium, small pericardium, swine heart valve, peritoneum, pleura or fascia, and the biocompatible material is not limited thereto. Ethylene, polypropylene, nylon, silk, polyurethane, polyethylene terephthalate, polyamide, polyacrylonitrile, polyethylene (PE), polyvinylchloride (PVC), polyvinylidene fluoride (PVDF), polysiloxane (Silicone Rubber) Or it may be a synthetic material containing polyvinyl alcohol.

In another aspect, the present invention is the manufacture of artificial valve leaf used in the mitral valve leaflet having a top plate having a lower surface corresponding to the upper surface of the artificial valve leaf described above and a lower plate having an upper surface corresponding to the lower surface of the upper plate. Provide the device.

Specifically, the artificial valve leaf manufacturing apparatus, the upper surface; Corresponding lower surface; And a side surface connecting the upper surface and the lower surface, the upper surface having a long axis; And a short axis orthogonal at a point spaced from the one end of the long axis by a distance corresponding to 0.40 to 0.60 times the length of the long axis, the length of the short axis being 0.55 to 0.90 times the length of the long axis, from one end to the long axis. The distance of may include an upper plate having a lower surface corresponding to the upper surface of the artificial valve leaf used for the mitral valve leaflet, which is 0.35 to 0.45 times the length of the short axis, and a lower plate having an upper surface corresponding to the lower surface of the upper plate. Can be.

At this time, the side surface may be formed of at least one surface selected from the group consisting of a curved surface and a plane along the circumference of the upper surface and the lower surface, more specifically, the two surfaces having a different radius of curvature are It may be made to contact at both ends.

The length of the long axis may be 0.7 to 0.8 times the diameter of the mitral valve. By manufacturing an artificial valve leaf manufacturing apparatus of various sizes according to the length of the mitral valve diameter, it is possible to quickly and accurately provide the artificial valve leaf that fits the size of the mitral valve of the patient.

In addition, an extension may be provided along the outer circumferential surfaces of the upper and lower surfaces, and the extension may be a margin for suturing the artificial valve leaf to the mitral valve leaf, specifically, the width of the expansion part may be 1.0 mm to 2.0 mm. .

In the apparatus for manufacturing artificial valve leaf according to the present invention, the upper surface of the upper plate or the lower surface of the lower plate may be formed in any shape, but according to one embodiment of the present invention, a shape corresponding to the lower surface of the upper plate and the upper surface of the lower plate Can be made. In addition, the material of the upper plate and the lower plate may be used as long as it is harmless to the human body, but preferably polycarbonate may be used.

According to one embodiment of the artificial leaflet manufacturing apparatus, after placing a biological material or a biocompatible material between the upper plate and the lower plate of the artificial leaflet manufacturing apparatus, using a cutting tool such as surgical scissors or knife upper and lower plates By cutting out the excess tissue out of the frame along the outer circumferential surface of the artificial valve leaf used in the anterior mitral valve can be prepared.

In one embodiment of the present invention, the artificial valve leaf manufacturing apparatus further comprises a first cutting portion along the outer peripheral surface of the lower surface of the upper plate and further a second cutting portion corresponding to the first cutting portion along the outer peripheral surface of the upper surface of the lower plate It can be provided. The first cutting portion and the second cutting portion may be, for example, a blade portion, but are not limited thereto, and include all of the sharp protrusions enough to cut the biological material or the biocompatible material. The first cutting part and the second cutting part are respectively formed along the periphery of the outer circumferential surface of the lower surface of the upper plate and the upper surface of the lower plate of the artificial valve leaf manufacturing apparatus. By completely bonding the two cutting portions, the artificial valve leaf having the same shape as the upper surface of the artificial valve leaf according to the present invention can be taken along the first cutting portion and the second cutting portion.

According to one embodiment of the artificial leaflet manufacturing apparatus, after placing a biological material or a biocompatible material between the upper plate and the lower plate of the artificial leaflet manufacturing apparatus, by joining the first cutting portion of the upper plate and the second cutting portion of the lower plate By cutting the biological material or biocompatible material along the cutting part, an artificial valve leaf used in the anterior mitral valve can be manufactured.

In another embodiment of the present invention, the artificial valve leaf manufacturing apparatus is connected to one side of the upper plate and the lower plate, the handle for fixing the upper plate and the lower plate may be additionally installed.

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

Artificial valve leaf 10 according to the present invention has an upper surface and a corresponding lower surface and a side connecting the upper and lower surfaces as shown in Figure 1, the upper surface has a long axis (a) and a short axis ( b), the long axis and the short axis perpendicularly intersect at the center of the long axis, the length b of the short axis is 0.55 to 0.65 times the length of the long axis a, and the distance c from one end of the short axis to the short axis is short. 0.3b to 0.45 times the length of (b), and the side surface is characterized in that the first curved surface 2 and the second curved surface 4 having different curvature radii are in contact with both ends of the long axis a. At this time, along the outer circumferential surface of the side to form an extension portion 20 to have a margin for suturing the mitral valve leaf and artificial valve leaf, the expansion portion is extended by 1.0 mm to 2.0 mm length from the outer peripheral surface of the artificial valve leaf Form.

Figure 2 is a plan view of the artificial valve leaf manufacturing apparatus coupled to the handle according to the present invention. The artificial valve leaf manufacturing apparatus according to the present invention is composed of an upper plate 40 and a lower plate 50 having an upper surface and a lower surface corresponding to the upper surface of the artificial valve leaf as shown in FIG. In this case, the handle 30 may be further provided to be connected to one side of the upper plate 40 and the lower plate 50 to couple and fix the upper plate and the lower plate.

Figure 3 is a view showing the use of the artificial valve leaf manufacturing apparatus used for the mitral valve anterior lobe according to the present invention. According to Figure 3 after placing the biological material or biocompatible material between the upper plate 40 and the lower plate 50 of the artificial valve leaf manufacturing apparatus, using the cutting tool such as surgical scissors or knife upper plate 40 and lower plate By cutting out the excess tissue out of the frame along the outer circumferential surface of (50), the artificial valve leaf used for the entire mitral valve lobe can be produced.

Looking at the use of the artificial valve leaf and artificial valve leaf production apparatus according to the present invention having the above configuration in performing the mitral valve prolongation as follows.

First, the diseased anterior mitral valve is partially excised from the annulus with a width of about 1 to 3 mm. And biological materials such as autologous pericardium, allocardial pericardium, small pericardium, porcine heart valve, peritoneum, pleura, fascia, or polytetrafluoroethylene, polypropylene, nylon, silk, polyurethane, polyethylene fixed to glutaraldehyde Biocompatibility, such as synthetic materials including terephthalate, polyamide, polyacrylonitrile, polyethylene (PE), polyvinylchloride (PVC), polyvinylidene fluoride (PVDF), polysiloxane (Silicone Rubber) or polyvinyl alcohol The material is placed between the upper and lower plates of the artificial valve leaf making apparatus of a suitable size according to the size of the anterior lobe of the mitral valve of the patient, and then the upper and lower plates are combined to match. At this time, the combined upper and lower plates are fixed so as not to shake by using a handle, and the artificial tissue leaf is produced by cutting out the excess tissue out of the frame along the outer peripheral surface of the upper and lower plates using a surgical scissors or a knife. Alternatively, when using an artificial valve leaf manufacturing apparatus provided with a cut portion, by manufacturing the artificial valve leaf by cutting the biological material or biocompatible material by bonding the cut portion of the upper plate and the lower plate. The remaining valve tissue of the previous partial mitral valve and the dilated portion of the artificial valve lobe are sealed with thread.

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 above description, and all changes or modifications derived from the already and scope of the claims and their equivalents should be construed as being included in the scope of the present invention. do.

Claims

Upper surface; Corresponding lower surface; And it has a side connecting the upper surface and the lower surface,

The upper surface has a long axis; And a short axis orthogonal at a point spaced apart from one end of the long axis by a distance corresponding to 0.40 to 0.60 times the length of the long axis,

The length of the short axis is 0.55 to 0.90 times the length of the long axis,

The artificial valve leaf used for the mitral valve anterior lobe consisting of 0.35 to 0.45 times the length of the short axis from one end of the short axis.
The method of claim 1,

Side is artificial valve leaf, characterized in that consisting of at least one surface selected from the group consisting of a curved surface and a plane along the circumference of the upper surface and the lower surface.
The method of claim 2,

Side is artificial valve leaf, characterized in that the two curved surfaces with different curvature radii are in contact at both ends of the long axis.
The method of claim 1,

The length of the long axis is artificial valve leaf, characterized in that 0.7 to 0.8 times the diameter of the mitral valve.
The method of claim 1,

An artificial valve leaf further comprising an extension along the outer circumferential surface of the upper and lower surfaces.
The method of claim 5,

An artificial valve leaf, characterized in that the width of the extension is 1.0 mm to 2.0 mm.
The method of claim 1,

Artificial valve leaf is an artificial valve leaf, characterized in that consisting of a biological material or biocompatible material.
The method of claim 7, wherein

Biological substances include autologous pericardium, allocardial pericardium, small pericardium, swine heart valve, peritoneum, pleura or fascia.
The method of claim 7, wherein

Biocompatible materials include polytetrafluoroethylene, polypropylene, nylon, silk, polyurethane, polyethylene terephthalate, polyamide, polyacrylonitrile, polyethylene (PE), polyvinylchloride (PVC), polyvinylidene fluoride ( PVDF), polysiloxane (Silicone Rubber) or artificial valve leaf, characterized in that the synthetic material containing polyvinyl alcohol.
An upper plate having a lower surface corresponding to the upper surface of the artificial valve leaf according to any one of claims 1 to 9; And a lower plate having an upper surface corresponding to the lower surface of the upper plate.
The method of claim 10,

The apparatus for manufacturing artificial valve leaf further comprising a second cutting portion corresponding to the first cutting portion further comprising a first cutting portion along an outer circumferential surface of the lower surface of the upper plate.
The method according to claim 10 or 11, wherein

Connected to one side of the upper plate and the lower plate artificial valve leaf manufacturing apparatus characterized in that the handle is further provided to combine and secure the upper plate and the lower plate.