KR20150136910A - Tissue protective device for the cerclage annuloplasty procedure in use of the coil spring, and tissue protective device making method - Google Patents

Abstract

The present invention relates to a protective device for a mitral cerclage annuloplasty procedure using coil springs and a method for manufacturing the same and, more specifically, to a method for manufacturing a tissue protective device using coil springs to protect tissues in a human body (heart) from a cerclage thread while performing a mitral cerclage annuloplasty procedure on a mitral regurgitation patient, and a tissue protective device manufactured thereby. The tissue protective device for a mitral cerclage annuloplasty procedure according to a preferred embodiment of the present invention comprises: a hollow coil spring for coronary sinus for protecting coronary sinus tissues; a hollow coil spring for a tricuspid valve for protecting tissues of the tricuspid valve and interventricular septum; and a stem part in which the hollow coil spring for coronary sinus and the hollow coil spring for a tricuspid valve are attached to each other on side surfaces. The method for manufacturing a tissue protective device for a mitral cerclage annuloplasty procedure using coil springs according to a preferred embodiment of the present invention comprises the following steps: manufacturing a coil spring for coronary sinus and a coil spring for a tricuspid valve; bending each of the coil spring for coronary sinus and the coil spring for a tricuspid valve from the lower portion in a predetermined length; and tightly coupling the upper portions of the the coil spring for coronary sinus and the coil spring for a tricuspid valve to each other.

Description

Technical Field [0001] The present invention relates to a tissue protecting device for a mitral valve closure technique using coil springs and a method for manufacturing the same,

[0001] The present invention relates to a protective device for a mitral valve circling operation using a coil spring and a method for manufacturing the same, and more particularly, to a method for manufacturing a mitral valve using a coil spring, The present invention relates to a method of manufacturing a tissue protecting mechanism for protecting a tissue using a coil spring, and a tissue protecting mechanism manufactured by the method.

The heart is an organ that acts as a blood pump. In order for this pump (heart) with muscles to work, a valve is required which allows blood flow to flow in a certain direction without backflow. The heart has four chambers, two atria and two ventricles, which are connected to four blood vessels: the aorta, the vein, the pulmonary artery, and the pulmonary vein.

The mitral valve (MV) between the left atrium and the left ventricle, the tricuspid valve (TV) between the right atrium and the right ventricle, the aortic valve between the left ventricle and the aorta, the aortic valve, The valve between the pulmonary arteries is the pulmonary valve (PV).

The valve should be fully open and closed in accordance with the beating of the heart. If it does not move completely, such as not closing completely or opening completely, liquid will flow backward or flow will be deteriorated. This is heart valve disease. Heart valve disease can be divided into two major categories: valve disease (reflux, regurgitation) and valve opening (valve stenosis).

Mitral valve regurgitation is a condition in which the mitral valve between the left atrium and the left ventricle is not closed when the valve is closed, causing the blood to flow backwards, resulting in heart failure, resulting in heart failure and eventually heart failure.

To date, treatment for mitral valve regurgitation is a standard treatment for the operation of opening the thoracic cavity of the chest and incising the heart to repair the mitral valve or substitute it with a prosthetic valve. This is a very invasive treatment that can cause up to 5% risk of death due to surgery alone, although the treatment is effective. To date, only very severe mitral regurgitation has been treated with surgery due to these limitations. Recently, there have been many studies on the development of percutaneous mitral valve repair that can repair the mitral valve by relatively simple procedure using a catheter without the need of opening the chest of the patient and requiring a heart incision. As part of such an international study, the present inventor has recently published an international paper on mitral cerclage coronary sinus annuloplasty (MVA), which involves applying a circular pressure around the mitral annulus (MA) And it is proved that the therapeutic effect is excellent. The contents of the above paper are international patent applications (International Application No. PCT / US2007 / 023836) and are now internationally published at the International Bureau (International Publication No. WO2008 / 060553).

To describe briefly the percutaneous mitral valve repair (mitral valve repair) described in the above paper and patent application, the catheter is placed in a 'coronary sinus' after approaching the right atrium via the jugular vein and the proximal septal vein ) 'To pass the thread necessary for the circle. This procedure can easily be achieved in one of the 'right ventricular outflow tract' (RVOT). This procedure is called simple mitral cerclage annuloplasty. This thread can easily be caught in the right atrium and this will result in the placement of a circular seal in tissue around the mitral annulus. If tension is applied to this thread, the mitral annulus will have the effect of incarceration, which will reduce the incomplete closure of the valve by bringing the two leaflets of the mitral valve closer together. This principle is directly related to the treatment of mitral annuloplasty, which is very similar to the surgical treatment, which is a therapeutic effect to reduce the backflow of blood through the mitral valve.

However, because the cerclage suture traverses the heart, it may result in impaired valvular function and damage to the valve and its appendages. The present inventors devised a tissue protection mechanism for the coronary sinus and threonine valve as a technique for protecting the tissue in the body (heart), and applied for a patent for it and obtained registration (Registration No. 10-1116867. Enrollment)

The tissue protection device of the above patent is inserted in the body, so that it is more flexible and more elastic so as to minimize the damage to the tissue of the body, can guarantee the superiority of the circlag procedure, Can be achieved. Therefore, there is a need for continuous research on organizational protection mechanisms.

International Publication No. WO2008 / 060553, published on May 22, 2008) Korean Patent Bulletin (Registration No.: 10-1116867, registered on Mar. 2, 2012)

An object of the present invention is to provide a tissue protecting mechanism for a mitral valve circling operation using a coil spring so as to make the tissue protecting mechanism for protecting the body tissue more flexible and more stable in the mitral valve circling procedure, .

Another object of the present invention is to provide a tissue-protecting mechanism for mitral leaflet circulation surgery, which is harmless and biocompatible to the human body, reduces the pressure applied to the myocardial muscle, will be.

SUMMARY OF THE INVENTION The present invention has been made to solve the above-mentioned problems, and it is an object of the present invention to provide a tissue protecting mechanism for a mitral valve closure technique, which comprises a coil spring for a hollow sinusoidal sinus protecting a coronary sinus tissue, A coil spring for a hollow triple valve for protecting the tissue, and a stem portion in which the coil spring for the coronary sinus and the coil spring for the triple valve coil are laterally joined.

The tissue protecting mechanism for the mitral annular circulation according to the preferred embodiment of the present invention includes a coil spring for a hollow sinusoidal sinus that protects the coronary sinus tissue, a coil spring for a triple valve and a hollow valve for protecting the ventricular septum, And the coil spring for the coronary sinus and the coil spring for the triple valve coil are laterally coupled to each other to a predetermined length from the upper side, and are separated from each other at the lower side.

A method for manufacturing a tissue protecting mechanism for a mitral valve circlcr treatment using a coil spring according to a preferred embodiment of the present invention includes the steps of manufacturing a coil spring for a coronary sinus sinusoidal coil spring and a coil spring for a coronary sinus sinusoidal coil spring, Bending each of the valve coil springs by a predetermined length at the lower side and tightly coupling the upper side of the coil spring for the coronary sinus coil and the coil spring for the triple valve coil.

As described above, the tissue protecting mechanism for the mitral valve circling operation using the coil spring of the present invention is made of a coil spring, so that it is more flexible and flexible than the catheter, can move with the beating of the heart, It has the merit of good flexibility and resilience.

In addition, it is coated with a biocompatible material, thereby avoiding direct physical contact with a coil spring of a metal to reduce an allergic reaction, prevent the harmfulness of thrombosis caused by penetrating blood between the mountains and mountains of the coil spring, There is an advantage in that it can improve deliverability.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a flow chart of a method of manufacturing a tissue protecting apparatus for a mitral valve circumcircle using a coil spring according to a preferred embodiment of the present invention. FIG.
FIG. 2 is a schematic perspective view of a tissue protecting mechanism for a mitral valve circlagger using a coil spring according to a preferred embodiment of the present invention. FIG.
FIG. 3 is a sectional view of a coil spring A for a coronary sinus and a coil spring B for a triangular valve, according to a preferred embodiment of the present invention.
4 is a cross-sectional view of a coil spring end portion of a triangular valve of a tissue protecting mechanism for mitral valve closure technique using a coil spring according to a preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, with reference to the accompanying drawings, a tissue protecting mechanism for a mitral valve circumjacent operation using a coil spring of the present invention and a method of manufacturing the same will be described in detail.

FIG. 1 is a flowchart of a method of manufacturing a tissue protecting mechanism for a mitral leaflet circling using a coil spring according to a preferred embodiment of the present invention, and FIG. 2 is a schematic view of a tissue protecting mechanism for a mitral leaflet circling procedure using a coil spring It is a perspective view.

First, the cerclage suture (10) is a thin thread with a thickness of about 0.014 "or less, which is used in the mitral cerclage coronary sinus annuloplasty (MVA), and a single strand of coronary sinus sinus, CS), tricuspid valve (TV), and ventricular septum in the form of a circle, and when it comes out of the body, it becomes a thread of two strands of one side and the other side . That is, as shown in FIG. 2, a circle is drawn and connected to one another. The material of the circular yarn may be synthetic resin such as nylon or metal (stainless steel, metal nylon coating, etc.) wire. Also, wires made by twisting a plurality of fine wires can be used. If the circle yarn 10 is formed by twisting a plurality of yarns (wires), it may be referred to as "circle yarn rope" or "circle large wire", which is also a kind of circle yarn yarn, Will belong to the scope.

The tissue protection mechanism 20 of the present invention includes a coil spring 22 for a hollow sinusoidal sinus that protects the coronary sinus tissue, a coil spring 24 for a triple valve membrane and a hollow triple valve membrane for protecting the ventricular septal tissue, And a stem portion 26 in which a coil spring for a coronary sinus and a coil spring for a triple valve coil are laterally joined to each other. That is, in other words, the tissue protection mechanism of the present invention is composed of a coil spring for a hollow sinusoidal sinus that protects the coronary sinus tissue, a triple valve membrane and a coil spring for a hollow triple valve membrane for protecting the tissue of the ventricular septum, The coil spring for the coronary sinus and the coil spring for the triple valve coil are coupled to each other to a predetermined length and have a structure separated from each other at the lower side. The wire thickness of the coil spring is about 0.5 mm, and the outer diameter of the coil spring is about 2 mm.

The most significant feature of the present invention is that a coil spring is used as a tissue protecting mechanism for protecting tissues. The coil spring is manufactured by winding a wire made of a metal in the form of a coil. The coil spring is flexible, flexible, movable along with the heartbeat, and flexible in shape and resilience. Using this flexibility and stability, it is possible to make a desired shape through tension in the case of circlag procedure. Preferably, the coil spring is made of stainless steel, but is not limited thereto.

The coil spring 22 for the coronary sinus is inserted into the coronary sinus to protect the coronary sinus tissue applied by the circular seal, and the coil spring 24 for the triple valve is inserted into the third valve plate, It plays a role in protecting the tissues of the 3,000 valve and ventricular septum.

Next, the manufacturing process will be described. First, a coil spring is manufactured (S10). The coil spring 22 for the coronary sinus and the coil spring 24 for the triple valve coil may be the same kind of coil spring, but preferably different kinds are used.

Preferably, in a circle procedure, the coil spring inserted into the coronary sinus needs to be relatively more flexible in terms of protection of the heart tissue. That is, the coil spring 22 for the coronary sinus needs to be relatively more flexible than the coil spring 24 for the triple valve coil having a high tensile stength.

3 is a cross-sectional view of a coil spring A for a coronary sinus and a coil spring B for a triple valve coil of a tissue protecting mechanism for mitral valve circular ring manipulation using a coil spring according to a preferred embodiment of the present invention.

Referring to FIG. 3, the coil spring 22 for a coronary sinus is a rectangular cross-section in which the narrow sides of the wire are rounded, and the narrow sides thereof are wound against each other (A) 24) has a circular cross section of the wire (B). That is, the coil spring 22 for the coronary sinus is a flat wire coil, and the coil spring 24 for a Samcheon leaf spring is a round wire coil. Accordingly, the coil 22 for the coronary sinus is relatively more flexible than the coil spring 24 for the triple valve having a high tensile stength.

The lower end portions of the coil spring 22 for the coronary sinus and the coil spring 24 for the triple valve coil are bent to form a curve (S20).

Each of the coil spring 22 for the coronary sinus and the coil spring 24 for the triple valve is inserted into the coronary sinus and the triple valve and is bent at a predetermined angle and a predetermined length so as to protect the heart tissue.

Next, the upper end portions of the coil spring 22 for the coronary sinus and the coil spring 24 for the triangular valve coil are laterally coupled to each other (S30). The stem portion 26 is formed by joining the upper end portions of the coil spring 22 for the coronary sinus and the coil spring 24 for the triangular valve membrane side by side.

The coil spring for the coronary sinus and the coil spring for the triple valve coil are engaged by pressing the press. More specifically, the coil spring for the coronary sinus and the coil spring for the triple valve coil are inserted together in a separate rubber tube, and then the rubber tube is pressed by a press.

Next, the outer surface of the coil spring for the coronary sinus and the coil spring for the triangular valve is coated with a biocompatible material (S40). The reason for coating with biocompatible materials is to protect the heart and arteries from damage by metal. In other words, by avoiding direct physical contact with the metal coil spring, it is possible to reduce the allergic reaction, prevent the harmfulness such as blood clotting into blood and the like between the mountains and mountains of the coil spring, Can be improved.

As a biocompatible material, for example, expanded polytetrafluoroethylene (ePTFE) is used.

Various methods can be used for coating the coil spring with Teflon. For example, after a taped Teflon sheet (ePTFE sheet) is wound around a coil spring, the Teflon sheet can be pressed (coated) onto the coil spring by thermocompression bonding. Alternatively, Teflon in a liquid phase may be applied to a coil spring, or Teflon in a liquid phase may be first applied to a coil spring, the coil spring may be wound again with a Teflon sheet (ePTFE sheet) . The thickness of the coating is about 0.1 mm. In addition, various coating methods can be used, and this also falls within the scope of the present invention.

On the other hand, a stopper (RVOT exit stopper) 25 having an outer diameter larger than the outer diameter of the coil spring for the triple valve coil is formed at the end of the coil spring for the triple valve coil. The stopper 25 prevents the coil spring 24 for the triple valve coil from further digging into the heart muscle. The material of the stopper 25 is biocompatible material, for example, Teflon.

4 is a cross-sectional view of a coil spring end portion of a triple valve valve of a tissue protecting mechanism for mitral leaflet circling using a coil spring according to a preferred embodiment of the present invention. (S denotes a coil spring, and C denotes a coating portion)

2 and 4, the upper portion of the stopper 25 has an umbrella shape rounded. The reason why the upper part is rounded is to prevent further digging into the myocardium. A stopper of an umbrella shape rounded on the upper side is formed by using Teflon, and then the stopper is bonded to the coil spring end portion of the valve stem by thermal fusion.

The stopper 25 has a function of preventing the end of the coil spring 24 for the triple valve coil from being caught by the cardiac muscle so that it is no longer inserted and the coil spring 24 for the triple valve coil has a reverse C ' It can act as a part supporting one side when forming. The hinge portion 27, which is a portion where the coronary sinus coil spring 22 and the triple valve coil spring 24 are separated from each other, is caught at the edge of the CS inlet. In this case, the hinge portion 27 and the stopper (RVOT exit stopper) 25 of the three-valve coil spring 24 which are caught on the myocardium are fixed, so that the coil spring 24 for the three- It maintains a reverse 'C' shape and floats around the TV (TV). This action acts to prevent erosion of the three-valve valve by the circulation chamber 10 and also to less restrict the movement of the valve leaflets.

While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. It will be understood by those skilled in the art that various changes, substitutions and alterations can be made herein without departing from the spirit or scope of the invention as defined by the appended claims.

10: Circle thread (Circle rope)
20: Coil spring tissue protection mechanism
22: Coronary sinus coil spring
24: coil spring for three thousand valve
25: Stopper (RVOT exit stopper)
26: Line donation
27: Hinge section
40: Coronary sinus protection

Claims (29)

CLAIMS 1. A tissue protective device for mitral valve closure technique,
Coil springs for hollow coronary sinus to protect the coronary sinus tissue;
A coil spring for a three thousand valve and a hollow valve for protecting the tissue of the ventricular septum;
Wherein the coil spring for the coronary sinus and the coil spring for the triple valve coil are coupled to each other laterally. 2. The tissue protecting apparatus for a mitral annulus according to claim 1, wherein the coil spring for the coronary sinus is relatively more flexible than the coil spring for the triple valve coil. The method according to claim 1,
The coil spring for a coronary sinus is a structure in which a wire cross section is formed in a rectangular shape in which both narrow sides are rounded,
Wherein the coil spring for the triple valve coil is circular in cross section. The method according to claim 1,
Wherein the coil spring for the coronary sinus and the coil spring for the triple valve coil are bent at a predetermined angle and a predetermined length. The method according to claim 1,
Wherein the tissue protection mechanism is coated with a biocompatible material. ≪ RTI ID = 0.0 > 8. < / RTI > The method according to claim 1,
Wherein the tissue protection mechanism is coated with Teflon. 2. The tissue protecting apparatus of claim 1, wherein the tissue protection mechanism is coated with Teflon. The method according to claim 6,
Wherein the Teflon is coated with a tissue protecting mechanism by thermocompression after winding a tissue protecting mechanism with a Teflon sheet, and then applying a wire coil spring to the tissue protecting mechanism. The method according to claim 6,
Wherein the Teflon is formed by spraying liquid teflon onto the outer surface of the tissue protection mechanism. The method according to claim 6,
The Teflon is coated on the tissue protection mechanism by applying a liquid Teflone to the tissue protection mechanism first, then wrapping the tissue protection mechanism with a Teflon sheet (PTFE sheet) again, Tissue protective device for membrane occlusion. The method according to claim 1,
Wherein a coil spring of the triple valve coil spring has a stopper having an outer diameter larger than an outer diameter of the coil spring for the triple valve coil. 11. The method of claim 10,
Wherein the stopper is made of a Teflon material. ≪ RTI ID = 0.0 > 15. < / RTI > 11. The method of claim 10,
Wherein the stopper has an umbrella shape rounded on the upper side thereof. CLAIMS 1. A tissue protective device for mitral valve closure technique,
Coil springs for hollow coronary sinus to protect the coronary sinus tissue;
And a hollow coil spring for protecting the tissue of the ventricular septum,
Wherein a coil spring for a coronary sinus and a coil spring for a triple valve coil are coupled to each other laterally from the upper side to a predetermined length and separated from each other at a lower side thereof. 14. The tissue protecting apparatus for a mitral annulus using the wire coil spring according to claim 13, wherein the coil spring for the coronary sinus is relatively more flexible than the coil spring for the triple valve coil. 14. The method of claim 13,
The coil spring for a coronary sinus is a structure in which a wire cross section is formed in a rectangular shape in which both narrow sides are rounded,
Wherein the coil spring for the triple valve coil is circular in cross section. 14. The method of claim 13,
Wherein the lower end of each of the coil spring for the coronary sinus and the coil spring for the triple valve is bent at a predetermined angle and a predetermined length. 14. The method of claim 13,
Wherein the tissue protection mechanism is coated with a biocompatible material. ≪ RTI ID = 0.0 > 8. < / RTI > 14. The method of claim 13,
Wherein the tissue protection mechanism is coated with Teflon. 2. The tissue protecting apparatus of claim 1, wherein the tissue protection mechanism is coated with Teflon. 14. The method of claim 13,
Wherein a coil spring of the triple valve coil spring has a stopper having an outer diameter larger than an outer diameter of the coil spring for the triple valve coil. 20. The method of claim 19,
Wherein the stopper is a Teflon material, and the stopper has an umbrella shape rounded on the upper side thereof. A method for manufacturing a tissue protecting mechanism for a mitral valve closure technique using a coil spring,
Preparing a coil spring for a coronary sinus and a coil spring for a triple valve;
Bending the coil spring for the coronary sinus and the coil spring for the triple valve by a predetermined length at the lower side;
And tightly coupling the upper side of the coil spring for the coronary sinus sinusoidal coil spring and the coil spring for the triangular valve coil to each other. 22. The method of claim 21,
The coil spring for a coronary sinus is a structure in which a wire cross section is formed in a rectangular shape in which both narrow sides are rounded,
Wherein the coil spring for a triple valve coil has a circular cross section of a wire. 22. The method of claim 21,
Wherein the coupling between the coil spring for the coronary sinus sinusoidal coil spring and the coil spring for the trivalent valve is performed by pressurization. 22. The method of claim 21,
Wherein the coupling of the coil spring for the coronary sinus sinusoidal coil spring and the coil spring for the coronary sinus sinusoidal coil spring is performed by inserting the coil spring for the coronary sinus coil spring and the coil spring for the tri- A method for manufacturing a tissue protective device for operation. 22. The method of claim 21,
Further comprising the step of coating the outer surface of the coil spring for coronary sinus sinusoidal coil spring with the biocompatible material on the outer surface of the coil spring for coronary sinus sinusoidal coil spring. 26. The method of claim 25,
Wherein the coating is made of Teflon material. ≪ Desc / Clms Page number 20 > 27. The method of claim 26,
Wherein the coating of the Teflon is performed on a coil spring by thermocompression after being wound on a coil spring with a Teflon sheet. 27. The method of claim 26,
Wherein the Teflon is formed by spraying liquid teflon onto the outer surface of the tissue protecting mechanism. 27. The method of claim 26,
The method for coating the Teflon is characterized in that Teflon in a liquid phase is applied to a coil spring, the coil spring is wound again with a Teflon sheet (PTFE sheet), and then the coil spring is coded by thermocompression. Method of manufacturing tissue protective device.

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