Tissue protection device for mitral valve membrane cerclage procedure

Abstract

The present invention relates to a tissue protection device for mitral valve cerclage annuloplasty and, more particularly to a tissue protection device for protecting tissues of the body (heart) during mitral valve cerclage annuloplasty that is performed on a mitral valve cerclage patient with mitral regurgitation. The tissue protection device for mitral valve cerclage annuloplasty of the present invention is a hollow cylindrical tube where cerclage sutures (10a, 10b) are inserted, in which a hole (22) is formed at a predetermined portion of the cylindrical tube so that a coronary sinus cerclage suture (10a) inserted in a coronary sinus comes out of the cylindrical tube, and a lower section from the hole is inserted into the tricuspid valve to protect tissues of the tricuspid valve and the ventricular septum.

Claims

1. A cerclage assembly for mitral valve annuloplasty, comprising: a hollow tube having an upper open end, a lower open end, and a side hole on a side of the tube, wherein the hollow tube has a C-shaped section located between the side hole and the lower open end; a cerclage suture having a proximal segment and a distal segment, wherein the cerclage suture travels through and around the tube in the following loop path: into the upper open end of the tube; through the tube towards the lower open end; out the lower open end of the tube; forming a loop outside the tube; into the side hole of the tube; through the tube towards the upper open end; out the upper open end of the tube; wherein both the proximal segment and the distal segment of the cerclage suture travel into or out of the upper open end; wherein both the proximal segment and distal segment of the cerclage suture are positioned outside the tube.

2. The cerclage assembly of claim 1, wherein the side hole is permanently open.

3. The cerclage assembly of claim 1, further comprising a stopper on the hollow tube located between the side hole and the lower open end.

4. The cerclage assembly of claim 3, further comprising a protrusion on the hollow tube located between the stopper and the side hole.

5. The cerclage assembly of claim 3, wherein the distance between the side hole of the tube and the stopper is about twice the distance from the stopper to the lower open end of the tube.

6. The cerclage assembly of claim 1, wherein a support section of the hollow tube spans the side hole, and wherein the hollow tube is thicker at the support section than the C-shaped section.

7. The cerclage assembly of claim 1, wherein a support section of the hollow tube spans the side hole, and wherein the support section is more rigid than the C-shaped section.

8. A method for assembling a cerclage assembly for mitral valve annuloplasty, comprising: having a hollow tube with an upper open end, a lower open end, and a side hole on a side of the tube; having a cerclage suture with a proximal segment and a distal segment; inserting the cerclage suture into the upper open end of the tube; advancing the cerclage suture through the tube towards the lower open end; advancing the cerclage suture out the lower open end of the tube; looping the cerclage suture outside the tube; inserting the cerclage suture into the side hole of the tube; advancing the cerclage suture through the tube towards the upper open end; advancing the cerclage suture out the upper open end of the tube; wherein both the proximal segment and distal segment of the cerclage suture are positioned outside the tube.

9. The method of claim 8, wherein the side hole is permanently open.

10. The method of claim 8, forming a C-shape curve at a section of the hollow tube located between the side hole and the lower open end.

11. The method of claim 8, further comprising connecting the proximal segment and distal segment of the cerclage suture together.

Description

DESCRIPTION OF DRAWINGS

(1) FIG. 1 is a schematic perspective view of the tissue protection device for mitral valve cerclage annuloplasty according to an embodiment of the present invention.

(2) FIG. 2 is a virtual partial cut view of a heart with the tissue protection device for mitral valve cerclage annuloplasty according to an embodiment of the present invention.

(3) FIG. 3 is a partial cross-sectional view of the tissue protection device for mitral valve cerclage annuloplasty according to an embodiment of the present invention.

BEST MODE

(4) Hereinafter, the tissue protection device for mitral valve cerclage annuloplasty of the present invention will be described in detail with reference to the accompanying drawings.

(5) FIG. 1 is a schematic perspective view of the tissue protection device for mitral valve cerclage annuloplasty according to an embodiment of the present invention and FIG. 2 is a virtual partial cut view of a heart with the tissue protection device for mitral valve cerclage annuloplasty according to an embodiment of the present invention.

(6) A cerclage suture 10, which is a very thin thread having a thickness of about 0.014 and used for mitral cerclage coronary sinus annuloplasty (MVA), was named in the meaning that a piece of string comes out of a body after going around a coronary sinus (CS), a tricuspid valve (TV), and a ventricular septum, and when the cerclage suture comes out of a body, it is divided into two pieces at one end and the other end. That is, a cerclage suture is divided into a coronary sinus cerclage suture 10a and a tricuspid valve cerclage suture 10b in FIG. 1, but it is one continuous string making a circle, as shown in the figure. The cerclage suture may be a string made of synthetic resin such as nylon or a metallic wire (stainless steel or metal coated with nylon). Further, a wire formed by twisting a plurality of thin wires may be used. When the cerclage suture 10 is made by twisting a plurality of strings (wires), it is also called a cerclage rope or a cerclage wire and it is also a kind of cerclage suture.

(7) A tissue protection device 20 is a hollow cylindrical tube where the cerclage sutures 10a and 10b are inserted. The tissue protection device 20 is a hollow cylindrical tube, that is, it has an empty inside and is manufactured as thick as a 4Fr catheter. The material is a soft and flexible rubber or synthetic resin. Alternatively, a metal spring coated with biological synthetic resin may be used.

(8) As for each part of the tissue protection device 20, the device is composed of a stem section 23 that is the upper part, a support section 26 that is the middle part, and a tricuspid valve insert 24 that is the lower part. The parts collectively make one hollow thin cylindrical tube.

(9) The tissue protection device of the present invention has a hole 22 at a predetermined position and the hole 22 is a part through which the coronary sinus cerclage suture 10a inserted in a coronary sinus comes out of the cylindrical tube. The support section 26 is defined to predetermined positions over and under the hole 22, the step section 23 is defined over the support section, and the tricuspid valve insert 24 for protecting a tricuspid valve and a ventricular septum is defined under the support section.

(10) The coronary sinus cerclage suture 10a and the tricuspid valve cerclage suture 10b are connected to each other. The cerclage suture 10a that is supposed to be inserted into a coronary sinus is not covered with the tube in the coronary sinus, so it may be formed to be more rigid than the tricuspid valve cerclage suture 10b in order to protect the coronary sinus tissues. The coronary sinus cerclage suture 10a is formed thicker than the tricuspid valve cerclage suture 10b and thus damage to the coronary sinus tissues due to the coronary sinus cerclage suture is prevented.

(11) The support section 26 where the hole 22 for the coronary sinus cerclage suture 10a to come out of the tissue protection device 20 is connected to the stem section 23 and positioned under the stem section 23.

(12) The support section 26 is formed to be more rigid than the stem section 23 or the tricuspid valve insert 24. This is for more stably supporting the coronary sinus cerclage suture 10a when the coronary sinus cerclage suture 10a comes out of the hole.

(13) FIG. 3 is a partial cross-sectional view of a tissue protection device for mitral valve cerclage annuloplasty according to an embodiment of the present invention.

(14) As shown in FIG. 3, the support section 26 is thicker than the tricuspid valve insert 24. That is, since it is preferable that the support section 26 is more rigid than the tricuspid valve insert 24, the tube is formed thicker at the support section 26 than at the tricuspid valve insert 24. In order to make the support section rigid, the outer diameter of the support section may be increased or the support section may be made of a different material.

(15) The tricuspid valve insert 24 connected to the support section 26 is a part that protects the tricuspid valve and the ventricular septum from the cerclage suture 10b that is inserted in the tricuspid valve.

(16) A stopper 24a is formed at a lower end portion of the cylindrical tube (that is, a lower end portion of the tricuspid valve insert) to prevent the tissue protection device from going deep inside the myocardium. The stopper 24a may be a circular protrusion, as shown in the figure. Further, as shown in the figure, the lower end portion of the cylindrical tube (that is, the lower end portion of the tricuspid valve insert) may become narrower as it goes to the end in order to cover the cerclage suture 10b in a ventricular septum.

(17) The distance between an RVOT stopper 24a and the hole 22a is selected in advance such that the tricuspid valve insert 24 is around two times longer than the distance between an RVOT exit and the coronary sinus hole that is measured from a scanning image of a patient obtained in advance. That is, the distance between the hole 22 and the stopper 24a is designed around two times longer than the distance from the stopper to the end. To this end, it may be possible to change the position of the stopper at the tricuspid valve insert 24, but various tissue protection devices having different distances between the hole 22 and the stopper 24a may be provided.

(18) When the coronary sinus cerclage suture 10a coming out of the tissue protection device 20 is inserted into the coronary sinus, the hole 22 is locked to the edge of a CS inlet. Accordingly, the stopper 24a of the tricuspid valve insert 24 (RVOT exit stopper) and the hole 22 are fixed, so the tricuspid valve insert 24 is curved into a reverse C-shape as long as the length without being in contact with the wall of the tricuspid valve (TV). Accordingly, erosion of the tricuspid valve due to the cerclage suture 10 is prevented and movement of lobes of the mitral valve is less limited.

(19) On the other hand, a protrusion 27 may be formed on the outer side of the tissue protection device 20, as shown in the figure. The protrusion 27 prevents the tissue protection device from being excessively inserting into the body by locking to a tissue inside the body and supports a side when the tricuspid valve insert 24 is curved in a reverse C-shape.

(20) The embodiments described above are just examples of the present invention and the scope of the present invention is not limited to the embodiments. The present invention may be changed, replaced, and modified in various ways by those skilled in the art without departing from the scope of the present invention described in claims.

INDUSTRIAL APPLICABILITY

(21) The present invention can be used for a tissue protection device for mitral valve cerclage annuloplasty and, more particularly to a tissue protection device for protecting tissues of the body (heart) during mitral valve cerclage annuloplasty that is performed on a mitral valve cerclage patient with mitral regurgitation.