WO2016013763A1

WO2016013763A1 - Apparatus and method for fixing mitral cerclage wire

Info

Publication number: WO2016013763A1
Application number: PCT/KR2015/006041
Authority: WO
Inventors: 김준홍
Original assignee: (주)타우피엔유메디칼
Priority date: 2014-07-22
Filing date: 2015-06-16
Publication date: 2016-01-28
Also published as: KR20160011381A

Abstract

The present invention relates to fixing apparatus and method for fixing both ends of a mitral cerclage wire used in mitral cerclage coronary sinus annuloplasty, and more specifically, with respect to a mitral cerclage coronary sinus annuloplasty performed on a patient exhibiting mitral regurgitation, to mitral cerclage wire fixing apparatus and method allowing both ends of a mitral cerclage wire, which comes back out as if tracing a circle, to be fixed as well to be released of the fixed hold as needed. The fixing apparatus for fixing a mitral cerclage wire according to a preferred embodiment of the present invention comprises: a fixed body having a through-hole having an insertion hole into which the wire is inserted and two exit holes through each of which the wire exits; a bolt, inserted into the fixed body by screw-coupling thereto by means of a rotating means, for fixing 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 same from rotating when the bolt is rotated by the rotating means.

Description

Mitral Valve Circle Large Wire Fixture and Method

The present invention relates to a fixing device and a fixing method for fixing both ends of the circular large wire for mitral valve circular surgery, more specifically, in the mitral valve circular surgery for patients with mitral regurgitation The present invention relates to a fixing device and a fixing method for mitral valve circle large wires, which can fix both sides of the large circle wires coming out and release the fixing as necessary.

The heart is an organ that acts as a blood pump. To operate this muscle pump (heart) requires a valve that allows blood flow to flow in a constant direction rather than backflow. The heart has four rooms, two atriums and two ventricles, which are connected to four vessels: the aorta, veins, pulmonary arteries, and pulmonary veins.

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

The valve should open and close completely according to the heartbeat. If it does not move properly, such as not fully closed or fully open, fluid will flow back or flow badly. This is heart valve disease. Heart valve disease can be divided into two types: a disease that causes blood to leak completely (closure, regurgitation) and a disease that does not open completely when the valve needs to be closed (stenosis).

Mitral regurgitation is a disease in which the mitral valve, the valve between the left atrium and the left ventricle, does not close completely when it is closed, resulting in blood backflow, which results in a burden on the heart, which results in heart failure and eventually causes heart failure.

To date, treatment for mitral regurgitation is the standard treatment of surgery, which involves opening the sternum of the chest and opening the heart to repair the mitral valve or replace it with an artificial valve. This is a very invasive method of treatment that is effective but can occur as much as 5% of the risk of death of the patient due to surgery alone. Due to these limitations, until now only very severe mitral regurgitation has been treated with surgery. Against this backdrop, many studies have been made on the development of percutaneous mitral valve repair that can repair the mitral valve by relatively simple procedure using a catheter without opening the chest of the patient and requiring the incision of the heart. As part of this international study, we have published an international paper on Mitral cerclage coronary sinus annuloplasty (MVA), which can apply circular pressure around the mitral annulus (MA). It proved that the therapeutic effect is excellent. The contents of the paper have been filed in international patent applications (International Application No .: PCT / US2007 / 023836) and are now published internationally by the International Bureau (International Publication No. WO2008 / 060553).

Briefly describing the percutaneous mitral valve surgery (mitral circular surgery) described in the above paper and the patent application, the catheter is placed into the 'tubular sinus' after accessing the right atrium through the jugular vein and the 'proximal septal vein'. Pass the thread needed for the circle large with ')'. This thread can easily come out as one of the right ventricular outflow tracts (RVOTs). The method was named the simple mitral cerclage annuloplasty procedure. This thread can be easily grasped into the right atrium, thereby placing the circle large yarn in the tissue around the mitral annulus. Applying tension to the thread gives the effect of imprisoning the mitral valve, which reduces the incomplete closure of the valve by bringing the two valves of the mitral valve closer together. This principle has a very similar effect to the surgical treatment of direct mitral mitral valve repair, which is a therapeutic effect that reduces the backflow of blood through the mitral valve.

However, since the cerclage suture crosses the heart, there may be damage to the valve function and damage to the valve and its appendages. The present inventors devised a tissue protection mechanism of coronary sinus and three thousand valves as a technique for protecting the tissues in the body (heart), and obtained a patent application after obtaining the patent (Korea Registration No.:10-1116867. 2012.02. 08 registration)

Since the tissue protection mechanism of the Korean patent is inserted into the body (heart), it is more flexible and more elastic to minimize damage to the tissues of the body, and to ensure the superiority of the circle large procedure, and the circle large Perfection of the procedure can be achieved.

In mitral valve circle large surgery, the circle large thread, which rotates around the circle like a circle, needs to be fixed inside the body. It may be necessary to refit the thread after it has been repositioned.

As such, there is a need for research on a technique for easily fixing or releasing both ends of a circle large thread in a mitral valve circle large procedure, and also for simple and simple fixation or release.

The present invention is to solve the above problems, an object of the present invention is to conveniently fix both ends of the circle large wire in the mitral valve circle large procedure, at the same time, the fixing is not easily released, if necessary fixed conveniently It is to provide a fixing device and a fixing method for fixing both ends of the mitral valve circle large surgical circle large wire that can be released.

In order to achieve the above object of the present invention, in accordance with a preferred embodiment of the present invention, the fixing device for fixing the mitral valve circle large wire, the insertion hole into which the wire is inserted and the two exit holes from which the wire comes out, respectively A fixed body having a through hole formed therein, the fixed body screwed into the fixed body by the rotating means, a bolt for pressing and fixing the wire inserted into the through hole, and rotation of the fixed body when the bolt is rotated by the rotating means. And a holder fastened to the fixed body 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 tannery wrench bolt rotatable by a wrench which is a rotating means.

According to a preferred embodiment, it has a pointed shape tapered to favor pressurization of the wire of the bolt.

According to a preferred embodiment, the front surface of the holder is formed with a polygonal inner surface, the outer surface of the fixing body is formed a polygonal outer surface corresponding to the polygonal inner surface of the holder, the polygonal inner surface of the holder and the polygonal outer surface of the fixing body It is fastened to each other, and the rotation of the fixed body is prevented when the bolt is rotated by the rotating means.

According to a preferred embodiment, the holder has a through-hole formed therein, through which the fixing body and the bolt is inserted.

In accordance with a preferred embodiment of the present invention, the fixing device for fixing the mitral valve circle large wire, the fixing body is formed with a through-hole having an insertion hole into which the wire is inserted and two exit holes from which the wire comes out, and the rotating means And a bolt that is inserted into the fixed body by screwing and presses and fixes the wire inserted into the through hole. .

According to a preferred embodiment of the present invention, the method for fixing both ends of the mitral valve circle large wire i) First, the circle large wire is inserted through the insertion hole of the fixing body to the circle through the hole of the fixed body so that each exit hole Inserting the large wire, ii) rotating the bolt using the rotating means, the bolt presses and secures the circular large wires at both ends, and iii) removing the rotating means.

As described above, according to the present invention, the bolt is inserted into the fixing body, and the wire is fixed and released by the bolt, so that it can be fixed conveniently. Since it can be re-adjusted, there is an advantage that can increase the safety and success rate of the mitral valve circle large procedure.

In addition, the fixing device of the present invention is very simple and has a convenient structure, there is an advantage that the fixing and release of the wire can be convenient.

In addition, in the present invention, by providing a holder, the fixing body does not rotate during the rotation of the bolt, there is an advantage that it is possible to secure the circle large wire safely and conveniently.

1 is a perspective view of a mitral circle large wire fixing device, according to a preferred embodiment of the present invention.

2 and 3 are views illustrating a process of fixing a wire by using a mitral valve circular wire fixing device and a rotating means, according to a preferred embodiment of the present invention, and FIG. 3 is a state of FIG. Detailed view of.

Figure 4 is a flow chart for the method of fixing the mitral circular circle wire, according to a preferred embodiment of the present invention

Hereinafter, with reference to the accompanying drawings, it will be described in more detail the mitral valve circle large wire fixing device of the present invention.

Figure 1 is a perspective view of a fixing device for fixing the mitral valve circle large wire, according to a preferred embodiment of the present invention, Figure 3 shows a tissue protection mechanism and circular wire of the fixing device and mitral valve circle large procedure.

First, the mitral valve circle large procedure is a procedure for treating mitral regurgitation and / or angina pectoris. The circle large thread (circular wire) causes the heart to return as a circle, followed by a circle large thread (circle). Large wire) to treat mitral regurgitation and / or angina pectoris. To this end, a tissue protective device for protecting body tissues and a coronary artery protector for protecting a coronary artery are required.

In terms of terminology, the circle large thread (10, cerclage suture) is a thin thread of about 0.014 ”used in the mitral cerclage coronary sinus annuloplasty (MVA). (coronary sinus, CS) part, tricuspid valve (TV) part, ventricular septal part is named after coming out of the body in a circular shape, and when it came out of the body, two strands of one end and the other end Becomes That is, as shown in FIG. 3, the circle is drawn to connect one thread. The material of the circle large yarn may be made of synthetic resin such as nylon, or metal (stainless steel, nylon coated metal). It is also possible to use wires made by twisting a plurality of thin wires (also called "circle ropes"). Therefore, it is variously referred to as "circle yarn", "circle rope", "circle wire" and the like, all of which will be referred to as a kind of circle yarn of the present invention, will belong to the scope of the present invention.

Mitral circular circle tissue protection mechanism 20 is to protect the tissue of the heart from the circle large wire, a synthetic resin material such as a rubber material, a soft plastic material, or a metal material such as a coil spring can be used. That is, a rubber tube, a synthetic resin flexible tube, a metal coil spring, or the like can be used. Preferably, a coil spring is used that is soft and flexible, can move with the beating of the heart, is excellent in resilience with flexibility according to shape deformation, and has excellent deliverability during circular operations. Coil spring tissue protection devices are coated with biocompatible materials (e.g. ePTFE) to prevent direct physical contact with metal coil springs, reduce allergic reactions, and reduce blood allergies between acids and acids in the coil springs. Harmfulness can be prevented.

The arcuate coronary artery protector 30 is arcuate to protect the coronary artery. In the mitral valve circle large procedure, the circle large rope enters the coronary sinus, and when the circular large wire is confined to block the mitral annulus of the patient with mitral regurgitation, the circle large rope in the coronary venous sinus passing over the coronary artery Pressing results in problems that block the flow of blood in the coronary arteries and damage the coronary arteries. Therefore, in the above-mentioned International Publication (WO2008 / 060553, published May 22, 2008), a technique for protecting a coronary artery by inserting an arch in the coronary artery to protect the coronary artery is disclosed. The arcuate coronary artery protector 30 is also called a "coronary sinus protector" in the sense of being inserted into the coronary sinus or "coronary artery protector" in the sense of protecting the coronary artery. "Archial coronary artery protector" is a name given in the sense of being arched to be inserted into the coronary sinus and to protect the coronary artery.

The fixing device for fixing the mitral valve circle large wire includes a fixing body 40, a bolt 50, and a holder 60.

The fixing body 40 is a portion corresponding to the outer shape of the fixing device, the through-hole 43 having an insertion hole 41 into which the circle large wire 10 is inserted and two exit holes 42 each of which the wire comes out. Is formed. That is, two exit holes through which a wire comes out are formed, and both wires are comprised, respectively. This is to prevent the wires from being twisted with each other and at the same time to facilitate the pressurization by the bolts 50 so as to be more firmly fixed, thereby preventing the wires from being easily removed from the fixing device by the beating of the heart. Therefore, as shown, it is preferable that the through hole 43 having the insertion hole 41 and the two exit holes 42 has a V shape.

The bolt 50 is threaded on the outer surface is screwed into the fixed body 40 by the rotation means 70 is inserted, and fixed by pressing the wire 10 inserted into the through hole 43 of the fixed body 40 It plays a role. That is, the groove 50 is formed in the bolt 50, the rotary means 70 is inserted into the groove 51, and the rotating means rotates the bolt forward and backward to tighten the circle large wire 10 or Used for solving.

Preferably the bolt has a pointed shape tapered to favor the pressurization of the wire. This is to widen the contact surface with the wire inserted into the fixed body in which the V-shaped through hole is formed so that a tighter coupling is achieved.

Wrench bolts, boltless wrench bolts, cross bolts, straight bolts, etc. may be used, but most preferably, the boltless wrench bolts will be used since the bolt is inserted into the fixing body.

Rotating means 70 is a tool for tightening or loosening the bolt to insert the bolt 50 into the fixed body 40 to press the wire to securely fix or release the wire. The rotating means 70 may be a wrench or a driver corresponding thereto according to the groove of the bolt. Preferably, the bolt is a tannery wrench bolt is used, the rotation means is used a wrench corresponding thereto. This is because, in the case of the wrench bolt, the fastening by the rotation means is easier, and in the case of the wrenchless bolt, it can be inserted into the fixing body, thereby reducing damage to body tissues. Wrenches will generally be used with 6-head wrenches, but of course, various wrenches can be used.

The holder 60 is a part which is fastened to the fixing body to prevent the fixing body from rotating when the bolt is rotated by the rotating means. In other words, the holder is inserted into the body to prevent rotation of the stationary body. As shown, the holder has a through-hole 62 formed therein, the fixing body and the bolt is 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 fixing body. That is, the polygonal inner surface 64 of the holder and the polygonal outer surface 44 of the fixing body are fastened to each other to prevent rotation of the fixing body when the bolt is rotated by the rotating means.

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

Figure 2 illustrates the process of fixing the wire, using the mitral valve circle large wire fixing device and the rotating means, according to a preferred embodiment of the present invention, Figure 4 is a mitral valve circle, according to a preferred embodiment of the present invention It is a flow chart about the fixing method of a large wire.

Referring to Figures 2 and 4, i) first, the two large circular wires coming out of the body through the insertion hole of the fixed body through the insertion hole of the fixed body, each of the circular large wire in the through hole of the fixed body Insert (S10).

Although the bolt is inserted into the fixed body, but not completely fastened, the circle large wire is sufficiently movable through the through hole.

Sheath which inserts the rotating means into the groove of the bolt, and fits the inner surface of the holder to the outer surface of the fixing body, and then the fixed body, the bolt, the rotating means, and the holder are previously formed and installed as a passage in the circular treatment. Insert into the inside of the sheath. That is, the fixed body is inserted into the inside along the wire.

ii) Next, by rotating the bolt using a rotating means in a state of being inserted into a suitable position of the body, the bolt is to press the circular large wires at both ends to securely fix (S20). That is, the rotating means is rotated to advance the bolt, and the shear surface of the bolt presses the wire inserted into the through hole, thereby to fix it firmly. At this time, since the fixed body is fixed by the holder, that is, the polygonal inner surface of the holder is in contact with the polygonal outer surface of the fixed body, the fixed body is not rotated, the bolt can be coupled.

iii) Finally, after the fixing by the bolt, the holder, the step of removing the rotating means (S30). That is, the step of removing the holder and the rotating means into the body. Since both ends of the holder and the handle portion of the rotating means are rotated in a state that the outside of the body comes out of the body, the holder and the rotating means can be easily removed. Thereafter, the wire is removed at an appropriate position by the cutting means to complete the mitral valve circle large procedure.

After the wire is secured by the fasteners, it may be necessary to readjust the length, spacing, tightness, etc. of the circle large wires with continued cardiac activity. If such a need arises, the present invention can cope with the necessity by loosening by bolts by the rotation means, adjusting and re-tightening the wire properly, thereby further securing the safety of the mitral valve circle large procedure Will be.

The above description is merely illustrative of the technical idea of the present invention, and those skilled in the art to which the present invention pertains may make various modifications and changes without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed in the present invention are not intended to limit the technical spirit of the present invention, but are intended to explain, and the scope of the technical spirit of the present invention is not limited by these embodiments. The protection scope of the present invention should be interpreted by the claims below, and all technical ideas within the equivalent scope should be interpreted as being included in the scope of the present invention.

The present invention relates to a fixing device and a fixing method for fixing both ends of the circular large wire for mitral valve circular surgery, more specifically, in the mitral valve circular surgery for patients with mitral regurgitation It can be used in the field of fixing device and fixing method of mitral valve circular wire, which can fix both sides of the outgoing circular wire and at the same time release the fixing as necessary.

Claims

In the fixing device for fixing the mitral circle large wire,

A fixing body having a through hole having an insertion hole into which the wire is inserted and two exit holes from which the wire comes out;

A bolt which is inserted into the fixing body by screwing the rotating means and presses and fixes the wire inserted into the through hole; And

And a holder fastened to the fixed body to prevent rotation of the fixed body when the bolt is rotated by the rotating means.
The method of claim 1,

The through hole having the insertion hole and the two exit holes is characterized in that the V-shaped.
The method of claim 1,

And the bolt is a tannery wrench bolt rotatable by a wrench which is a rotating means.
The method of claim 1,

And a pointed shape tapered to favor pressurization of the wire of the bolt.
The method of claim 1,

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 fixing body.

The polygonal inner surface of the holder and the polygonal outer surface of the fixing body is fastened to each other, so that the rotation of the fixing body during rotation of the bolt by the rotating means is prevented.
The method of claim 1,

The holder has a through-hole formed therein, characterized in that the fixing body and the bolt is inserted through the through hole.
In the fixing device for fixing the mitral circle large wire,

A fixing body having a through hole having an insertion hole into which the wire is inserted and two exit holes from which the wire comes out; And

And a bolt which is inserted into the fixing body by screwing the rotating means and presses and fixes the wire inserted into the through hole.
The method of claim 7, wherein

The through hole having the insertion hole and the two exit holes is characterized in that the V-shaped.
The method of claim 7, wherein

And the bolt is a tannery wrench bolt rotatable by a wrench which is a rotating means.
The method of claim 7, wherein

And the front portion of the bolt has a pointed shape tapered to favor pressurization of the wire.
In the method of fixing both ends of the mitral valve circular wire,

i) first, inserting the circle large wire through the insertion hole of the fixed body through the insertion hole of the fixed body so that the circular large wire into the through hole of the fixed body (S10);

ii) rotating the bolt using the rotating means, and the bolt presses the circle large wire to fix it firmly (S20); And

iii) removing the rotating means (S30).
The method of claim 11,

In the step ii), the rotation of the fixed body is prevented by the holder when the bolt is rotated,

And the holder is removed in step iii).