KR101074093B1 - Artificial Valve Leaflet and Apparatus for Preparing the Same - Google Patents

Abstract

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

According to the present invention, an artificial valve leaf which can be used for mitral valve leaf arthroplasty can be easily manufactured and provided according to the size of the patient's mitral valve, thereby restoring and maintaining heart function by rebuilding the mitral valve leaf close to the original mitral valve. It can be used in mitral valve leaf surgery for the reconstruction of mitral valve leaf in the medical industry.

Mitral valve, Artificial valve lobe

Description

Artificial valve leaflet and its manufacturing apparatus {Artificial Valve Leaflet and Apparatus for Preparing the Same}

The present invention relates to an artificial valve leaf used in the mitral valve lobe used 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 valves that guide the flow of blood 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 (pulmonary), there is a tricuspid valve located between the right atrium and the right ventricle and a pulmonary artery valve located between the right ventricle and the pulmonary artery. At this point, oxygen is added again to resume circulation. The four heart valves described above are passive in that they do not consume their energy and do not have any active contraction, and are composed of movable 'leaflets' designed to open and close in response to the differential pressure of the valves. .

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 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 rheumatoid inflammation. The mitral regurgitation is caused by rheumatoid inflammation, degenerative changes of the valve, trauma such as myocardial ischemia, bacteria or fungal infections. This may occur due to poor closure or 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.

In mitral valve leaf arthroplasty, the mitral valve is completely resected and a new artificial valve lobe is attached to the annulus. The mitral valve lobe extension is performed in contrast to the mitral valve leaf replacement. A method of increasing the occlusal area of the valve leaflet by attaching a new artificial leaflet, followed by partial ablation without completely removing the original mitral leaflet, and by adding a new artificial leaflet to increase only the occlusal area of the leaflet without cutting the leaflet. There is a way to attach the valve leaf.

Conventional mitral valve prosthesis has limited limitation in effectively restoring the function of the mitral valve leaflet by making the mitral valve leaflet close to its original shape without accurate calculation of the size and shape of the mitral valve leaflet.

The present invention is to provide a synthetic valve leaflet manufactured according to the size of the mitral valve leaflet 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, wherein the upper surface is orthogonal at a distance corresponding to 0.40 to 0.60 from the long axis and one end of the long axis The length of the long axis is 1.1 to 1.3 times the mitral valve diameter, the length of the short axis is 0.2 to 0.3 times the diameter of the mitral valve, and the distance from one end of the short axis to the long axis is 0.2 to 0.4 times the length of the short axis. Provided is an artificial valve leaf used for mitral valve 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 maintain and can be usefully used in mitral valve leaf surgery for the reconstruction of mitral valve leaf in the medical industry.

The present invention has an upper surface and a corresponding lower surface and a side connecting the upper surface and the lower surface, wherein the upper surface is orthogonal at a distance corresponding to 0.40 to 0.60 from the long axis and one end of the long axis The length of the long axis is 1.1 to 1.3 times the mitral valve diameter, the length of the short axis is 0.2 to 0.3 times the diameter of the mitral valve, and the distance from one end of the short axis to the long axis is 0.2 to 0.4 times the length of the short axis. Provided is an artificial valve leaf used for mitral valve lobe.

The artificial valve lobe is manufactured according to the shape of the actual mitral valve of the mitral valve, and the distance from one end of the long axis to the long axis of the artificial valve lobe according to the length of the mitral valve diameter of the target patient to be performed. By determining the overall size and shape of the artificial valve leaf can be determined. Accordingly, by accurately preparing and applying an artificial valve leaf that fits the size and shape of the mitral valve leaf of the target patient, the function of the mitral valve can be effectively restored by restoring the original mitral valve leaflet.

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 an elliptic form. Means. At this time, the size of the mitral valve diameter is not limited thereto, but may be 20 to 44 mm.

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

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 point spaced 0.4 0.4 to 0.55 from one end of the long axis, preferably spaced 0.5 distance from one end of the long axis. It can be orthogonal to the long axis at the point, ie the center of the long axis.

According to another embodiment of the present invention, the length of the long axis may be 1.12 to 1.28 times the diameter of the mitral valve, preferably 1.14 to 1.26 times, more preferably 1.16 to 1.24 times, even more preferably 1.18 to 1.22 times.

According to another embodiment of the present invention, the length of the short axis may be 0.22 to 0.28 times the diameter of the mitral valve, preferably 0.24 to 0.26 times.

According to another embodiment of the invention, the distance from one end of the short axis to the long axis may be 0.25 to 0.35 times the length of the short axis, preferably 0.30 times.

In one embodiment of the present invention, the side surface of the artificial valve leaf may be made of one or more curved surfaces or 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 in particular, two curved surfaces having different curvature radii may be formed to contact at both ends of the long axis, or a plurality of curved surfaces and planes may be manufactured to form side surfaces.

According to a preferred embodiment of the present invention, the side surface of the artificial valve leaf is not limited thereto, the first curved surface; A second curved surface facing the first curved surface; And two planes connecting the first curved surface and the second curved surface. More specifically, the first curved surface and the first curved surface characterized in that the distance between the two ends of the first curved surface in contact with the plane is reduced to 3 to 4 mm in the length of the long axis; A second curved surface facing the first curved surface; And two planes connecting the first curved surface and the second curved surface.

In another embodiment of the present invention, the artificial valve leaf used for the mitral valve lobe may have an extension along the outer peripheral surface of the side surface. 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 an extra width for suturing the remaining mitral valve of the mitral valve and artificial valve lobe, 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 an animal such as human, cow, or pig, and the term "biocompatible substance" refers to a substance having a property that does not change its physical property in blood for a long time. it means. Specifically, the biological material may be, but is not limited to, autologous pericardium, allocardial pericardium, small pericardium, porcine 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 and a lower plate having an upper surface corresponding to the lower surface of the upper plate Provide a device.

Specifically, the artificial valve leaf manufacturing apparatus has an upper surface and a corresponding lower surface and a side connecting the upper surface and the lower surface, the upper surface corresponding to 0.40 to 0.60 from the long axis and one end of the long axis A short axis orthogonal at points spaced apart by a distance, the length of the long axis is 1.1 to 1.3 times the diameter of the mitral valve, the length of the short axis is 0.2 to 0.3 times the diameter of the mitral valve, and the distance from one end of the short axis to the long axis is It may be provided with an upper plate having a lower surface corresponding to the upper surface of the artificial valve leaf used in the mitral valve lobe consisting of 0.2 to 0.4 times the length and a lower plate having an upper surface corresponding to the lower surface of the upper plate.

At this time, the side surface may be formed of one or more curved surfaces or planes along the circumference of the upper surface and the lower surface, more specifically, the side surface is a first curved surface; A second curved surface facing the first curved surface; And two planes connecting the first curved surface and the second curved surface. More specifically, the first curved surface and the first curved surface characterized in that the distance between both ends of the first curved surface in contact with the plane is reduced by 3 to 4 mm in the length of the long axis; A second curved surface facing the first curved surface; And two planes connecting the first curved surface and the second curved surface.

In addition, an extension part may be provided along the outer circumferential surface of the side surface, and the extension part is a margin part for suturing the artificial valve leaf to the mitral valve leaf, and specifically, the width of the extension 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. According to one embodiment of the present invention, the lower surface of the upper plate and the upper surface of the lower plate correspond to each other. It may be made in a shape. 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 posterior lobe of the 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 for the posterior lobe of the mitral valve can be prepared.

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 the purpose of specifically describing the present invention, and the scope of the present invention is not limited by the following description.

1 is a plan view showing the artificial valve leaf used in the mitral valve lobe of the present invention.

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 (a) of the long axis being 1.1 to 1.3 times the diameter of the mitral valve, and the length (b) of the short axis being 0.2 to 0.3 times the diameter of the mitral valve. The distance (c) from one end of the short axis to the long axis is 0.2 to 0.4 times the length (b) of the short axis, and the side surface has a first curved surface; A second curved surface facing the first curved surface; And two planes connecting the first curved surface and the second curved surface, wherein a distance (b) between both ends of the first curved surface and the first curved surface is reduced to 3 to 4 mm in the length of the long axis. . 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 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 posterior lobe of the mitral valve is partially excised, leaving a width of about 1 to 3 mm in the mitral annulus. And biological materials such as autologous pericardium, allocardial pericardium, small pericardium, swine 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 suitable size according to the diameter size of the posterior 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. It is therefore to be understood that the above-described embodiments are to be considered 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.

1 is a plan view showing the artificial valve leaf used in the mitral valve lobe of the present invention.

Figure 2 is a plan view showing the artificial valve leaf manufacturing apparatus used in the mitral valve rear lobe 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 lobe according to the present invention.

<Description of the symbols for the main parts of the drawings>

2: first surface 4: second surface

6: first plane 8: second plane

10: artificial valve leaf 20: expansion

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

50: bottom plate of artificial valve leaf manufacturing apparatus

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

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

d: distance between both ends of the first curved surface and the first curved surface

Claims (12)

Upper surface; Corresponding lower surface; And it has a side connecting the upper surface and the lower surface, The upper surface includes a major axis and a minor axis orthogonal at a point spaced apart by a distance corresponding to 0.40 to 0.60 from one end of the major axis, The length of the long axis is 1.1 to 1.3 times the diameter of the mitral valve, The length of the short axis is 0.2 to 0.3 times the diameter of the mitral valve, The artificial valve lobe used for the posterior lobe of the mitral valve, which has a distance from one end of the short axis to 0.2 to 0.4 times the length of the short axis. The method of claim 1, Side is artificial valve leaf, characterized in that consisting of one or more curved surfaces or planes along the circumference of the upper and lower surfaces. The method of claim 2, The side surface is a first curved surface; A second curved surface facing the first curved surface; And two planar surfaces connecting the first curved surface and the second curved surface. The method of claim 3, The artificial valve leaf, characterized in that the distance between the first curved surface and both ends of the first curved surface is reduced by 3 to 4 mm in the length of the long axis. The method of claim 1, Artificial valve leaf characterized in that it comprises an extension along the outer peripheral surface of the side. 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 (PET), polyamide, polyacrylonitrile, polyethylene (PE), polyvinyl chloride (PVC), poly Artificial valve leaf, characterized in that the synthetic material containing vinylidene fluoride (PVDF), polysiloxane (Silicone Rubber) or 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 of claim 10, 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.

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