Mitral valve cerclage annuloplasty appratus and method thereof

Abstract

A mitral cerclage annuloplasty apparatus comprises a tissue protective device and a knot delivery device. The tissue protective device comprises a first protective tube and a second protective tube. The knot delivery device comprises a tube wherein a loose knot is looped around its distal end through a hole and wherein tight knot is formed when the distal end of the tube is cut open. Alternatively, the knot delivery device comprises an inner tube and outer tube. The inner tube is insertable and rotatable inside the outer tube. When the tubes are in a closed position by rotating either the outer tube or the inner tube, a hole is created near its distal end. When the tubes are in open position by rotating either the outer tube or the inner tube, the hole joins the opening of the outer tube and lengthens.

What I claim is: 
     
         1 . A method of treating mitral valve regurgitation in a patient, comprising:
 positioning a cerclage suture to wrap around the mitral valve annulus;   positioning a tube containing the cerclage suture to wrap around a tricuspid valve leaflet;   having the loose ends of the cerclage suture meet in the right atrium; and   pulling the loose ends of the cerclage suture to apply tension until mitral regurgitation is reduced.   
     
     
         2 . The method of  claim 1 , wherein the tube containing the cerclage suture is pushed out through a catheter. 
     
     
         3 . The method of  claim 1 , wherein the tube containing the cerclage suture takes a C-shape as it wraps around a tricuspid valve leaflet. 
     
     
         4 . The method of  claim 3 , wherein the “C”-shape portion of the tube is suspended freely without being directly attached to heart tissue. 
     
     
         5 . The method of  claim 1 , wherein the cerclage suture is wrapped around the mitral valve annulus by passing the cerclage suture into the proximal septal vein. 
     
     
         6 . The method of  claim 1 , further comprising feeding the cerclage suture into the tube prior to positioning to wrap around the tricuspid valve leaflet. 
     
     
         7 . The method of  claim 1 , wherein the tube has a stopper at a distal portion of the tube. 
     
     
         8 . The method of  claim 7 , further comprising selecting the distance of the stopper from the distal end of the tube by preintervention imaging analysis. 
     
     
         9 . The method of  claim 1 , further comprising embedding the distal end of the tube into heart muscle. 
     
     
         10 . The method of  claim 9 , wherein the tube has a stopper at a distal portion of the tube and the stopper prevents further advancement of the tube into the heart muscle. 
     
     
         11 . The method of  claim 1 , where the tube has a tapered shape at its the distal end. 
     
     
         12 . The method of  claim 1 , where the tube is approximately 4 French size. 
     
     
         13 . The method of  claim 1 , wherein the cerclage suture inside the tube does not make direct contact with the surrounding tissue. 
     
     
         14 . The method of  claim 1 , further comprising selecting the length of the tube by reviewing prior imaging studies of the patient. 
     
     
         15 . The method of  claim 1 , wherein the tube is a first tube and wherein the cerclage suture encircling the mitral valve annulus is contained in a second tube that is separate from the first tube. 
     
     
         16 . The method of  claim 15 , wherein the proximal end of the first tube and the proximal end of the second tube meet at a hinge portion formed by the conjunction of the two tubes. 
     
     
         17 . The method of  claim 15 , wherein the hinge portion of the two tubes is placed at or near the coronary sinus orifice of the heart and serves to prevent further advancement of the tubes into the coronary sinus orifice. 
     
     
         18 . The method of  claim 16 , wherein the distance from the hinge portion to the stopper is longer than actual endocardial surface length. 
     
     
         19 . The method of  claim 1 , further comprising:
 inserting the proximal end of the cerclage suture into a knot delivery catheter;   knotting the cerclage suture at the distal end of the knot delivery catheter;   advancing the knot delivery catheter to advance the knot towards the tube; and   tightening the cerclage suture knot.   
     
     
         20 . The method of  claim 19 , wherein the step of knotting the cerclage suture comprises inserting the suture through a hole at the distal end of the knot delivery catheter. 
     
     
         21 . The method of  claim 19 , further comprising cutting the cerclage suture at a position proximal to the knot. 
     
     
         22 . The method of  claim 1 , wherein the cerclage suture is advanced into the coronary sinus, into the proximal septal vein, around the mitral valve annulus, around a tricuspid valve leaflet, through the heart muscle, and out into the right atrium. 
     
     
         23 . A device for reducing mitral valve regurgitation, adapted to use a cerclage suture inserted therein comprising:
 a first protective tube having a proximal end, a distal end, a first orifice at the distal end, and an opening extending therebetween to receive a first portion of the cerclage suture therein;   a separate second tube having a proximal end, a distal end, a second orifice at the distal end, and an opening extending therebetween to receive a second portion of the cerclage suture therein, the proximal end of the first protective tube and the proximal end of the second protective tube contacting one another side by side substantially longitudinally along at least a portion of a length of the respective proximal ends, the distal ends being spaced from one another, with the first and second orifices generally facing one another;   a hinge portion defined at a position where the proximal ends of the first protective tube and the second protective tube cease contacting one another;   a generally U-shaped protective tube positioned between the distal end of the first protective tube and the distal end of the second protective tube, configured to receive one of the first cerclage suture and the second cerclage suture therein; and   an annular stopping element disposed on a portion of the second protective tube proximate the second orifice, the second protective tube being connected to the hinge portion and the annular stopping element;   wherein the second protective tube is suspended between the hinge portion and the annular stopping element without attachment to the heart tissue.   
     
     
         24 . The device according to  claim 23 , wherein the distal portion of the second protective tube is tapered. 
     
     
         25 . The device according to  claim 23 , the first protective tube and the second protective tube are made of a flexible material. 
     
     
         26 . The device according to  claim 23 , wherein the first protective tube and the second protective tube have a diameter approximately equivalent to a 4 Fr diagnostic catheter. 
     
     
         27 . The device according to  claim 23 , wherein the proximal portions of the first protective tube and the second protective tube are in close proximity to one another and form an engagement area for the cerclage suture. 
     
     
         28 . The device according to  claim 23 , wherein the proximal portions of the first and second longitudinally in contact protective tubes are attached along the at least a portion of the length of the proximal portions. 
     
     
         29 . The device according to  claim 23 , wherein a position of the stopping element on the distal portion of the second protective tube is variable. 
     
     
         30 . The device according to  claim 23 , wherein the hinge portion is adapted to stabilize the first and second protective tubes with respect to the heart tissue. 
     
     
         31 . The device according to  claim 23 , wherein the hinge portion is adapted to resist advancement of the heart tissue protective device with respect to the heart tissue. 
     
     
         32 . The device according to  claim 23 , wherein the distal portion of the first protective tube has an arched configuration so that the distal portion can be positioned to encircle a coronary sinus. 
     
     
         33 . The device according to  claim 23 , wherein the distal portion of the second protective tube is flexible enough to form an arch that encircles a tricuspid valve. 
     
     
         34 . The device according to  claim 23 , wherein the distal portion of the second protective tube is rigid enough to resist being bent inward as tension is applied. 
     
     
         35 . The device according to  claim 23 , wherein a portion of the second protective tube from the hinge portion to the stopper element forms an arch so that the arch is suspended freely without being directly attached to the heart tissue. 
     
     
         36 . The device according to  claim 23 , wherein the generally U-shaped protective tube is adapted to protect a coronary portion of the heart from the one of the first cerclage suture and the second cerclage suture. 
     
     
         37 . The device according to  claim 23 , wherein the generally U-shaped protective tube is configured to protect a coronary portion of the heart. 
     
     
         38 . A device for reducing mitral valve regurgitation, comprising:
 an elongated body comprising a proximal portion and a distal portion, the distal portion separating into a first arm and a second arm to create a hinge portion, the first arm configured to wrap around the mitral valve annulus, the first arm adapted to be delivered into a coronary sinus, the first arm configured to be positioned within the coronary sinus of the heart adjacent the mitral valve annulus within the heart, the second arm configured to wrap around the tricuspid leaflet, the hinge portion configured to be so positioned at or near the coronary sinus orifice of the hart that the first arm is prevented from further advancement, the second arm having a stopper element thereon.   
     
     
         39 . The device according to  claim 38 , wherein a distal portion of the second arm is tapered. 
     
     
         40 . The device according to  claim 38 , the first arm and the second arm are made of a flexible material. 
     
     
         41 . The device according to  claim 38 , wherein the first arm and the second arm have a diameter approximately equivalent to a 4 Fr diagnostic catheter. 
     
     
         42 . The device according to  claim 38 , wherein the hinge portion is adapted to stabilize the first and second arms with respect to the heart tissue. 
     
     
         43 . The device according to  claim 38 , wherein a distal portion of the first arm has an arched configuration so that the distal portion can be positioned to encircle a coronary sinus. 
     
     
         44 . The device according to  claim 38 , wherein a distal portion of the second arm is rigid enough to resist being bent inward as tension is applied. 
     
     
         45 . The device according to  claim 38 , wherein a portion of the second arm from the hinge portion to the stopper element forms an arch so that the arch is suspended freely without being directly attached to the heart tissue.