KR20020033646A - Device and method for treatment of mitral insufficiency - Google Patents

Abstract

The device for treating mitral annulus expansion comprises an elongated body 8 in two states. In the first of these states, the elongated body 8 is insertable into the cardiac vein 5 and has a shape conforming to the shape of the cardiac vein 5. When located in the cardiac vein 5, the elongated body 8 can be changed to a second state with a reduced radius of curvature, such that the radius of curvature of the cardiac vein 5 and the curvature of the mitral annulus 6 In addition to the radius, the circumference is reduced.

Description

Apparatus and method for treating mitral regurgitation {DEVICE AND METHOD FOR TREATMENT OF MITRAL INSUFFICIENCY}

Mitral regurgitation is due to ischemic disease, degenerative disease of the mitral valve instrument, rheumatic fever, endocarditis, congenital heart disease and cardiomyopathy. The four main components of the mitral valve are the ring, two pieces, the chodadae and the papillary muscle. One or both of the different combinations can be damaged and cause insufficiency. Ring dilation is a major component of lesions of mitral regurgitation, whatever the cause. In addition, many patients have mitral regurgitation due to, or primarily due to, posterior wheel dilation, because the anterior lateral ring is fixed to the fibrous skeleton of the heart and does not swell.

Natural history of mitral regurgitation has shown that patients without asymptomatic symptoms with severe mitral regurgitation develop into severe disability within 5 years. Currently, the therapy consists of either replacement or repair of the mitral valve, both requiring open heart surgery. Replacement can be done with mechanical or biological valves.

Mechanical valves pose a risk of thromboembolism with all the potential risks and require anticoagulants, but biological prostheses are problematic due to their limited durability. Another risk cause of replacement is the risk of endocarditis. These risks and other valve related complications can be greatly reduced by valve repair.

Repair of the mitral valve is essentially possible if there is a normal front piece. The four basic techniques of repair include the use of a ring-shaped ring, quadrant segmentation of the diseased posterior segment, shortening of the elongated coda, and dislocation to the posterior segment of the posterior coda.

Cylindrical rings are needed to achieve a continuous reduction in wheel expansion. All conventional rings are sutured along the back mitral valve piece adjacent to the mitral valve wheel in the left atrium. The Duran ring completely surrounds the valve, while the others open towards the front side. The rings may be hard, such as the original Carpentier ring, or soft but inelastic, such as the Duran ring or the Cosgrove-Edwards ring.

Currently, effective treatment of mitral regurgitation requires open heart surgery using cardiopulmonary bypass, aortic cross-clamping and cardiac arrest.

This is especially dangerous for certain groups of patients. A less invasive approach would be particularly advantageous for older patients, patients with poor left ventricular function, kidney disease, aortic calcification, past cardiac surgery or other concurrent diseases, although repair may not be complete. In addition, the current trend towards less invasive coronary surgery without PTCA as well as cardiopulmonary bypass requires the development of less invasive methods for the recovery of concurrent mitral regurgitation.

The present invention relates to an apparatus and method for the treatment of mitral regurgitation, and more particularly to the treatment of dilated mitral annulus.

1 is a cross-sectional view of a portion of the heart.

2 and 3 are schematic views of a first embodiment of the device according to the invention.

4-6 are schematic diagrams illustrating the instrument to be used when the device of FIGS. 2 and 3 is positioned in the coronary sinus.

FIG. 7 is a partially enlarged view of the first embodiment shown in FIG. 2.

8 and 9 are schematic views illustrating the placement of the device of FIGS. 2 and 3 in a coronary sinus.

10 and 11 are schematic views showing the positioning of a second embodiment of the device according to the invention in a coronary sinus.

12 and 13 are schematic diagrams showing the positioning of a third embodiment of the device according to the invention in a coronary sinus.

It is an object of the present invention to provide an apparatus and method for treating cardiopulmonary bypass and mitral regurgitation without opening the chest and heart.

A second object of the present invention is to provide a reduction of the mitral valve wheel using less invasive surgery.

These and other objects are obtained by the apparatus defined in the appended claims 1 and the method defined in the appended claims 7.

According to the present invention, an apparatus for treating mitral regurgitation includes an elongated body having two states with dimensions that can be inserted into the coronary sinus, and in a first state, the elongated body has a shape suitable for coronary sinus When the elongated body is located in the coronary sinus, it is deformed from the first state to a second state, which takes a reduced radius of curvature, which not only reduces the radius of curvature of the coronary sinus but also reduces the circumference of the mitral valve wheel.

Preferably, a means is provided for converting the elongated body into a second state by bending and / or shortening it from a larger radius of curvature to a smaller radius of curvature.

The diverting means comprises means for bending and / or shortening the elongated body by its asymmetrical contraction.

In addition, the elongated body may include a memory material to provide a transition to the second state.

In a preferred embodiment, the elongated body may comprise a stent. In an alternative embodiment, the device according to the invention may comprise several stent parts, and said bending and / or shortening means may comprise wires for shortening the distance between the stent parts.

According to a second aspect, a method of reducing the circumference of the mitral valve wheel includes inserting an elongated body into the coronary sinus adjacent to the rear side of the mitral valve, and bending and / or shortening the body when the elongated body is located in the coronary sinus. Reducing the radius of curvature of the coronary sinus by reducing the circumference of the mitral valve wheel.

Thus, the present invention utilizes the location of the coronary sinus sinus adjacent to the mitral valve wheel. This allows for recovery using current catheter guidance techniques.

Coronary veins drain blood from the myocardium into the right atrium. Rather, a smaller vein drains blood directly into the atrial cavity, and the larger vein, along with the main artery, proceeds substantially into the coronary sinus that surrounds the mitral valve cavity and rim. It proceeds to the posterior atrioventricular groove and is placed in the adipose tissue between the left atrium wall and the ventricular muscles before exiting between the atrial septum and the post-Eustachian cave.

In adults, the path of coronary sinus access is within 5-15 mm to the middle attachment point on the rear side of the mitral valve. Preliminary measurements made in the anatomy of the average body weight of the adult show similar results, with a distance of 5.3 ± 0.6 mm at the median attachment point and about 10 mm at the posterior side of the back side. The circumference of the coronary sinus was 18.3 ± 2.9 mm (5.8 ± 0.9 mm in diameter on the posterior side) in the hole and 9.7 ± 0.6 mm (corresponding to a diameter of 3.1 ± 0.2 mm) on the posterior side of the posterior segment.

The invention will be better understood by the following preferred embodiments with reference to the attached drawings.

1 is a cross-sectional view through the heart region of the posterior atrioventricular groove 1 filled with adipose tissue. It shows the rear piece 2 of the mitral valve and the adjacent parts 3, 4 of the atrial and ventricular muscles. A coronary sinus 5 is shown behind the attachment 7 of the rear piece 2 adjacent to the mitral ring 6. In addition, since the coronary sinus 5 substantially surrounds the mitral canal ring 6, a reduction in the radius of curvature of the curved coronary artery 5 will result in a reduction in the diameter and circumference of the mitral canal ring 6.

The device of FIG. 2 comprises an elongated body 8 made of a memory metal, for example nitinol or other similar material, having the memory of the original shape shown in FIG. 3, with the temporarily different shape shown in FIG. 2. Can be forced. This elongated body 8 may comprise one or more memory metal springs 9, one of helical or other shape, to fit together or to allow the following movement. Along the elongated body 8, several hooks 10 are fixed and extend radially therefrom. These hooks 10 are covered with the cover sheet 11 of FIG. 2.

The elongated body 8 is forced into an unfolded or extended state by the stabilization mechanism 12 shown in FIG. This mechanism 12 has two arms 13 at the far end 14 of the rod 15 and a locking means 16 at the close end of the rod 15. The distance between the ends of the rod 15 corresponds to the desired length of the elongated body 8 when inserted into the coronary sinus.

The arm 13 moves freely between the position shown in FIG. 4 and the position aligned with the rod 15 shown in FIG. 6. The locking means 16 have two locking knobs 17, which are compressed radially outwardly from the rod 15 by two spring blades 18. Thus, the elongated body 8 can be unfolded between the arm 13 and the knob 17 by being pushed onto the rod 15 of the stabilization mechanism 12, eventually leading to the arm 13 and the knob shown in FIG. 5. It can be locked in the unfolded state on the stabilization mechanism 12 between (17).

The rod 15 may be a metal wire that is relatively inflexible between the far end 14 and the locking means 16, but may be bent in accordance with the shape of the coronary sinus 5. In the vicinity of the locking means 16, the metal wire of the stabilization mechanism 11 is more flexible and can be easily bent in accordance with the bending of the vein.

The elongated body 8 is located in the coronary vein in the following manner:

An introduction sheet of synthetic material (not shown) can be used to access the venous system. Upon reaching the venous system, a long metal guide wire (not shown) advances through the venous system of the coronary sinus 5 through the introduction sheet. This guide wire is provided with an X-ray distance marker so that the position of the guide wire in the coronary sinus 5 can be observed.

The elongated body 8 is locked onto the stabilization mechanism 12 as shown in FIG. 5 and introduced into the elongated cover sheet 11 of synthetic material. This assembly is then pushed through the introduction sheet, and the venous system is pushed into the coronary sinus 5, where it lifts up the guide wire. After the elongated body 8 is correctly positioned in the coronary sinus 5, as shown in FIG. 8, in which the mitral valve 19 has a central gap 20, the lid sheet 11 is coronary sinus 5. The long body (8) in the inside is exposed and peeled. This means causes the hook 10 on the elongated body 8 to dig into the wall of the coronary sinus 5 and into the heart. The elongated body 8 remains locked on the stabilization mechanism 12 so that the hook 10 engages the walls of the coronary sinus 5 with the elongated body 8 unfolded or extended.

The catheter 21 shown in FIG. 6 compresses the spring blade 18 towards the rod 15 and forwards on the guide wire and rod 15 to release the elongated body 8 from the locking means 16. Pushed back. This movement releases the arm 13 as well as the knob 17 from the engagement with the retracted elongated body 8 as shown in FIG. 9, eventually bending towards the mitral valve valve wheel 6 to displace its rear portion. Move forward (as shown by the arrow in FIG. 9). This movement reduces the circumference of the mitral valve valve wheel 6 to close the center gap 20.

7 shows the hook 10 along the aligned portion of the wire 9 and the peripheral portion of the elongated body 8, whereby the connecting portion 22 of some or all of the hook 10 is shortened to its original shape. The elongated body 8 asymmetrically contracts and shows its bending.

10 and 11 show an alternative embodiment of an elongated body 8 ′, which is a rigid wire of an open U-shaped ring, which is mitral valve wheel 6 when it is inserted into the coronary sinus 5. It will mesh with the wall of the coronary vein (5) closest to it. The elongated body 8 'is made of a storage metal material that bends as shown in Figure 11 when it returns to its original shape. Recovery of the open ring 8 'to its original shape can be initiated in a number of ways that will be apparent to those skilled in the art.

The elongated body 8 "of the third embodiment shown in FIGS. 12 and 13 has three stent portions 23-25 respectively positioned at one end, the middle and the other end of the elongated body 8". It includes. This stent portion 23-25 will be located in the coronary sinus 5 as shown by conventional means, and thus its position is fixed. They are connected by wires 26, 27, and the wires are moved from outside the venous system such that the distance between adjacent stent portions 23, 24 and 24, 25 is reduced. More specifically, these distances decrease asymmetrically, i.e. on the side of the coronary sinus (5) closest to the rear part of the mitral valve wheel (6). Thus, the elongated body 8 " bends as shown in FIG. 13 and compresses the coronary sinus 5 with respect to the mitral valve wheel 6 to close the gap 20.

As a result, the present invention provides a device that is located in the coronary sinus and is designed to slow the expansion of the mitral valve wheel. The device is located at a distance from the attachment point of the posterior segment that does not exceed the distance at which the annular ring is located for open heart surgery, and the coronary sinus is large enough to secure the device along its entire path. The device may be positioned by catheter technique or any suitable technique, presenting a safer alternative to current open heart surgery. The device is designed to be heparin coated to avoid thrombosis in the coronary sinus, thereby reducing the need for aspirin, tislopedine and anticoagulant therapy.

It is to be understood that variations of the apparatus and methods may be made by those skilled in the art without departing from the spirit and scope of the invention.

Claims (10)

It has dimensions that can be inserted into the coronary sinus 5, the elongated body 8, 8 ', 8 "in the first state has a shape that can adapt to the shape of the coronary sinus 5, the elongated body 8, 8 ', 8 ") is positioned in the coronary sinus 5, the elongated body 8, 8', 8" may deform from the first state to a second state with a reduced radius of curvature, and thus coronary sinus For treating mitral wheel expansion including an elongated body (8, 8 ', 8 ") in two states, in which the radius of curvature of (5) is reduced and the circumference of the mitral valve valve wheel (6) is decelerated. Device. The device of claim 1, further comprising means 9, 22, 26, 27 for switching the elongated body to the second state by bending and shortening the elongated bodies 8, 8 "from a larger radius of curvature to a smaller radius of curvature. Device comprising a. Device according to claim 2, characterized in that the switching means (9, 22, 26, 27) comprise means for bending and shortening the elongated body (8) by its contraction. 2. Device according to claim 1, characterized in that the elongated body (8, 8 ') comprises a memory material which provides a transition to the second state. Device according to claim 1 or 2, characterized in that the elongated body (8) comprises a stent. 3. The wire 26, 27 according to claim 2, wherein the elongated body 8 "comprises several stent portions 23-25, and the bending means 9, 22, 26, 27 shorten the distance between the stent portions. Device). Inserting the elongated body (8, 8 ', 8 ") into the coronary sinus (5) proximal to the rear side of the mitral valve; and when the elongated body (8, 8' 8") is located in the coronary sinus (5) Reducing the circumference of the mitral valve valve wheel 6 by reducing the curvature of the coronary sinus 5 by bending and shortening the elongated body 8, 8 ′, 8 ″. . 8. Method according to claim 7, characterized in that the step of bending and shortening the elongated body (8, 8 ") is provided by its contraction. 9. Method according to claim 7 or 8, characterized in that the memory material is used in the elongated body (8 ') to provide a transition to the second state. The elongated body 8 "is made from several stent portions 23-25, and the wires 26, 27 are elongated by reducing the distance between the stent portions 23-25. A method characterized by bending the body (8 ").