KR20160011381A - apparatus and method for fixing the cerclage wire in Mitral cerclage coronary sinus annuloplasty - Google Patents

Abstract

The present invention relates to an apparatus and a method for fixing both ends of a mitral cerclage wire used in mitral cerclage coronary sinus annuloplasty and, more specifically, to an apparatus and a method for fixing both ends of a mitral cerclage wire, which comes back out of the heart as if tracing a circle and, at the same time, releasing the fixed hold according to necessity, with respect to a mitral cerclage coronary sinus annuloplasty performed on a patient exhibiting mitral regurgitation. The apparatus for fixing a mitral cerclage wire according to a preferred embodiment of the present invention comprises: a fixed body including a through-hole having an insertion hole into which the wire is inserted and two exit holes through which the wire exits; a bolt which is inserted into the fixed body by being screw-coupled thereto by means of a rotating means, and fixes the wire inserted into the through-hole by pressing down on the wire; and a holder fastened to the fixed body so as to prevent the same from rotating when the bolt is rotated by the rotating means.

Description

[0001] The present invention relates to mitral annular coronary sinus annuloplasty,

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a fixing device and a fixing method for fixing both ends of a circumferential wire for a mitral valve circling procedure. More particularly, the present invention relates to a fixing device and a fixing method for fixing both ends of a circumferential wire To a fixing device and a fixing method for a mitral annulus of a mitral valve which can secure both sides of a circumferential wire coming out from the mitral annulus and release the fixation if necessary.

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 this international study, the present inventor has published an international paper on mitral cerclage coronary sinus annuloplasty (MVA), which can be used to apply a circular pressure around the mitral annulus (MA) Therefore, it is proved that the treatment 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 inventor devised a tissue protection mechanism for the coronary sinus and threonine valve as a technique for protecting the tissues in the body (heart), and applied for a patent before obtaining the registration (Korean Registration No. 10-1116867, 2012.02. 08 Registration)

The above-mentioned Korean patented tissue protection device is inserted in the body (heart), so that it is more flexible and more elastic so as to minimize the damage to the tissue of the body, can secure the superiority of the circlag procedure, The perfection of the procedure can be achieved.

The mitral annular circulation procedure requires that the circlip thread rotate around the heart as if it is a circle, and that the circlip thread coming out of the body needs to be fixed in the body, and, if necessary, It is necessary to readjust the position of the thread and fix it again.

As described above, there is a need for research on a technique which can easily fix both sides of the circulatory chamber in the mitral valve closure procedure, and which can be easily fixed and released.

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

SUMMARY OF THE INVENTION It is an object of the present invention to solve the above problems, and it is an object of the present invention to provide a method and apparatus for conveniently fixing both ends of a circumferential wire in a mitral valve circlip procedure, The present invention also provides a fixation device and a fixation method for fixing both ends of a circumferential wire for mitral valve surgery.

According to another aspect of the present invention, there is provided a fixation device for fixing a mitral annulus of a mitral annulus, comprising: an insertion hole into which the wire is inserted; A bolt for screwing the wire inserted into the through hole and screwing the wire into the through hole by the rotating means, and a rotating body for rotating the fixing body when the bolt is rotated by the rotating means. And a holder which is fastened to the fixed body so as to prevent it.

According to a preferred embodiment, the through hole having the insertion hole and the two exit holes has a V shape.

According to a preferred embodiment, the bolt is a toothed wrench bolt which is rotatable by means of a wrench which is a rotating means.

According to a preferred embodiment of the present invention, the bolt has a tapered shape so as to facilitate the pressing of the wire.

According to a preferred embodiment of the present invention, a polygonal inner surface is formed on the front surface of the holder, and a polygonal outer surface corresponding to the polygonal inner surface of the holder is formed on the outer surface of the fixed body. And the rotation of the fixing body is prevented when the bolt is rotated by the rotating means.

According to a preferred embodiment, a hole is formed in the holder, and the fixing body and the bolt are inserted through the hole.

According to a preferred embodiment of the present invention, a fixation device for fixing a mitral annulus of a mitral annulus comprises a fixation body having a through hole into which the wire is inserted and a through hole having two exit holes from which the wire is respectively passed, And a bolt that is screwed into the fixing body and presses and fixes the wire inserted into the through hole. .

According to a preferred embodiment of the present invention, a method of fixing both ends of a mitral annulus of a mitral annulus is performed by i) first inserting a circle large wire through an inserting hole of a fixing body, Inserting the large wire, ii) rotating the bolt using the rotating means, and pressing the circular large wire at both ends of the bolt tightly to fix the bolt, and iii) removing the rotating means.

As described above, according to the present invention, a bolt is inserted into a fixed body and the wire is fixed and released by a bolt, so that it can be conveniently fixed, and if necessary, This can improve the safety and success rate of the mitral valve closure technique.

Further, since the fixing device of the present invention has a very simple and convenient structure, there is an advantage that the fixing and releasing of the wire can be made convenient.

In addition, according to the present invention, since the holder is provided, the fixing body can be prevented from rotating during rotation of the bolt, and the circular wire can be securely and conveniently fixed.

1 is a perspective view of a mitral annular large-diameter wire fixation device according to a preferred embodiment of the present invention;
2 and 3 are views for explaining a process of fixing a wire using a mitral annular large wire fixing device and a rotating means according to a preferred embodiment of the present invention, Detailed view of.
4 is a flowchart of a method for fixing a mitral annulus of a mitral valve according to a preferred embodiment of the present invention

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a mitral annular circumferential wire fixing device of the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 is a perspective view of a fixation device for fixing a mitral annulus of a mitral annulus according to a preferred embodiment of the present invention, and FIG. 3 shows a tissue protecting mechanism and a circumferential wire of a fixation device and a mitral valve seal ring technique.

First, mitral valve closure procedure is a treatment for mitral valve regurgitation and / or angina pectoris. After the circulation wire (circle wire) turns the heart into a circle, Raji wire) to treat mitral regurgitation and / or angina. To this end, tissue protective devices to protect the body tissues and coronary artery protectors to protect the coronary arteries are needed.

The term "cerclage suture" refers to a thin thread about 0.014 "thick, which is used in mitral cerclage coronary sinus annuloplasty (MVA) (CS), tricuspid valve (TV), and ventricular septum in a circle, and when it comes out of the body, the two strands of one side and the other side . That is, as shown in Fig. 3, a circular shape 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. A wire made by twisting a plurality of thin wires (also referred to as a " circle rope ") can also be used. Therefore, it is called various types such as "circle circle", "circle circle rope", "circle circle wire" and the like, all of which are a kind of circle circle of the present invention and belong to the scope of the present invention.

The mitral annular ring tissue protecting mechanism 20 is for protecting the heart tissue from the circular wire, and may be made of a synthetic resin material such as a rubber material, a soft plastic material, or a metal material such as a coil spring. That is, a rubber material tube, a synthetic resin refractory tube, a metal coil spring, or the like can be used. Preferably, coil springs are used which are flexible, flexible, move with the heartbeat, have flexibility due to shape deformation, excellent resilience, and excellent deliverability in circulation procedures. Coil spring tissue protection devices are coated with biocompatible materials (eg ePTFE) to prevent direct physical contact with metal coil springs, to reduce allergic reactions, and to prevent blood clots, such as blood, Harmfulness can be prevented.

The arcuate coronary artery protector 30 is an arcuate portion that protects the coronary artery. In the mitral valve closure procedure, the clavicle enters the coronary sinus, which, in turn, blocks the mitral annulus in patients with mitral valve regurgitation. When the clavicle is corroded, the clavicle within the coronary sinus passes over the coronary artery, The pressure of the blood in the coronary artery is blocked and the coronary artery is damaged. Accordingly, a technique for protecting the coronary artery by inserting an arch into the coronary artery to protect the coronary artery is disclosed in the above-mentioned International Publication (WO2008 / 060553, published on May 22, 2008). The arcuate coronary artery protector 30 is also referred to as a " coronary artery protector "in the sense of protecting the coronary artery or" coronary sinus guard " in the sense of being inserted into the coronary sinus. The "arcuate coronary arteriosclerosis" is the name given in the sense that it has an arch shape inserted into the coronary sinus to protect the coronary arteries.

The fixation device for fixing the mitral annular large wire includes a fixed body (40), a bolt (50), and a holder (60).

The fixed body 40 corresponds to the outer shape of the fixing device and includes a through hole 41 into which the circular wire 10 is inserted and a through hole 43 with two outlets 42 through which the wire is respectively passed. . In other words, two outlet holes through which the wires exit are formed so that both wires come out. This is to prevent the wires from being twisted together and to be pressed more tightly by the bolts 50 so that the wires can not easily get out of the fixing device due to the beating of the heart. Therefore, preferably, as shown in the drawing, the through hole 41 and the through-hole 43 having the two exit holes 42 preferably have a V-shape.

The bolt 50 is threaded on the outer surface and is screwed into the fixed body 40 by the rotating means 70. The wire 10 inserted in the through hole 43 of the fixed body 40 is pressed . That is, the bolt 50 is provided with the groove 51, the rotating means 70 is inserted into the groove 51, the bolt is moved back and forth by rotating the rotating means, and the circular wire 10 is tightened It is used for washing.

Preferably, the bolt is tapered so as to be advantageous in pressing the wire. This is to make the contact surface with the wire inserted in the fixed body formed with the V-shaped through hole wider so as to achieve a more rigid coupling.

The bolt may be a wrench bolt, a toothed wrench bolt, a cross bolt, a flat bolt or the like, but most preferably, the bolt is inserted into the fixing body so that the wrench bolt will be used.

The rotating means 70 is a tool for tightening or unscrewing the bolt 50 in order to insert the bolt 50 into the fixed body 40 so as to press the wire firmly to fix or unfasten the wire. The rotating means 70 may be a wrench or a screwdriver corresponding to the groove of the bolt. Preferably, the bolt is a tundra wrench bolt, and the rotating means uses a corresponding wrench. This is because, in the case of a wrench bolt, the fastening by the rotating means is easier, and when the wrench is a wrench bolt, it can be inserted into the fixed body, thereby reducing damage to the body tissue. The wrench will generally be a six-point wrench, but it is also possible to use a wide variety of wrenches.

The holder 60 is a portion which is fastened to the fixed body so as to prevent rotation of the fixed body when the bolt is rotated by the rotating means. That is, the holder is inserted into the body to prevent rotation of the fixed body. As shown in the figure, the holder has a through hole 62 formed therein, and the fixing body and the bolt are inserted through the through hole.

A polygonal inner surface 64 is formed on the front surface of the holder and a polygonal outer surface 44 corresponding to the polygonal inner surface 64 of the holder is formed on the outer surface of the fixed body. That is, the polygonal inner surface 64 of the holder and the polygonal outer surface 44 of the fixed body are fastened to each other to prevent rotation of the fixed body when the bolt is rotated by the rotating means.

Next, a method for fixing the wire using the fixing device of the present invention will be described in detail.

FIG. 2 illustrates a process of fixing a wire using a mitral annular large wire fixing device and a rotating means, according to a preferred embodiment of the present invention. FIG. 4 is a cross- And a method of fixing the large wire.

2 and 4, i) First, the two large-diameter circular large wires coming out of the body are inserted through the insertion holes of the fixed body, (S10).

The bolts are inserted into the fixed body, but not fully deeply engaged, so that the large wire can be moved sufficiently through the through hole.

The rotating means and the holder are inserted into the groove of the bolt and fitted to the polygonal outer face of the fixed body so that the inner face of the holder is in contact with the inner face of the holder, into the inside of the sheath. That is, the fixed body is inserted into the wire along the wire.

ii) Next, the bolt is rotated by using the rotating means in a state where it is inserted into a proper position of the body, and the bolts are pressed and fixed firmly at both ends (S20). That is, the rotating means is rotated to advance the bolt, so that the front end surface of the bolt presses the wire inserted into the through hole and fixes the wire firmly. At this time, the fixed body is fixed by the holder, that is, the multi-angle inner surface of the holder is in contact with the multi-angle outer surface of the fixing body, so that the fixing body can be engaged with the bolt without rotating.

iii) Finally, when the fixing by the bolt is completed, the holder and the rotating means are removed (S30). That is, the holder and the rotating means are taken out into the body. The holder and the rotating means can be removed very easily since the end of the holder and the handle of the rotating means are both rotated out of the body. Thereafter, the wire is removed from the proper position by the cutting means, thereby completing the mitral valve curcail procedure.

After fixation of the wire by the fixation device, it may be necessary to re-adjust the length, spacing, tightness, etc. of the circle wire by continuous action of the heart. If such a necessity arises, in the present invention, it is possible to cope with the necessity by loosening the bolt by means of the rotating means, adjusting the wire appropriately after tightening it again, and thus further securing the safety of the mitral valve closure technique .

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the invention may be embodied otherwise without departing from the spirit and scope of the invention. Therefore, the embodiments disclosed in the present invention are not intended to limit the scope of the present invention, but are intended to be illustrative, and the scope of the present invention is not limited by these embodiments. The scope of protection of the present invention should be construed according to the following claims, and all technical ideas within the scope of the claims should be construed as being included in the scope of the present invention.

10: Circle yarn (Circle rope, Circle wire)
20: tissue protective device 22: coronary sinus tube
24: Three valve tube 26:
27: hinge part 28:
30: Arch Coronary Artery Pouch
40: fixed body 41: insertion hole
42: exit hole 43: through hole
44:
50: bolt 51: groove
52:
60: holder 62: through hole
64:
70: rotating means

Claims (12)

A fixing device for fixing a mitral annular large wire,
A fixing body having a through hole into which the wire is inserted and a through hole having two outlet holes through which the wire is respectively ejected;
A bolt threadedly inserted into the fixing body by the rotating means and pressing and fixing the wire inserted into the through hole; And
And a holder coupled to the fixed body to prevent rotation of the fixed body when the bolt is rotated by the rotating unit. The method according to claim 1,
Wherein the through hole having the insertion hole and the two exit holes has a V-shape. The method according to claim 1,
Wherein the bolt is a tundish wrench bolt which is rotatable by a wrench which is a rotating means. The method according to claim 1,
Wherein the bolt has a tapered shape so as to be advantageous in pressing the wire of the bolt. The method according to claim 1,
Wherein the holder has a polygonal inner surface formed on a front surface thereof and a polygonal outer surface corresponding to a polygonal inner surface of the holder is formed on an outer surface of the fixed body,
And the polygonal inner surface of the holder and the polygonal outer surface of the fixed body are engaged with each other to prevent rotation of the fixed body when the bolt is rotated by the rotating means. The method according to claim 1,
Wherein the holder has a through hole formed therein, and the fixing body and the bolt are inserted through the through hole. A fixing device for fixing a mitral annular large wire,
A fixing body having a through hole into which the wire is inserted and a through hole having two outlet holes through which the wire is respectively ejected; And
And a bolt threadedly engaged with the fixing body by the rotating unit and pressing and fixing the wire inserted into the through hole. 8. The method of claim 7,
Wherein the through hole having the insertion hole and the two exit holes has a V-shape. 8. The method of claim 7,
Wherein the bolt is a tundish wrench bolt which is rotatable by a wrench which is a rotating means. 8. The method of claim 7,
Characterized in that the front portion of the bolt has a tapered shape so as to be advantageous for pressing the wire. A method of fixing both ends of a mitral annular loop wire,
i) inserting the large wire into the through hole of the fixed body so as to insert the large wire through the inserting hole of the fixed body and to exit to the other outlet hole (S10);
ii) rotating the bolt using the rotating means so that the bolt presses and secures the large wire (S20); And
iii) removing the rotating means (S30). 12. The method of claim 11,
In the step ii), rotation of the fixing body is prevented by the holder when the bolt is rotated,
And the holder is removed in step iii).

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