Methods and apparatus for cardiac valve repair

Abstract

The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.

1 . A method of repairing a valve in a patient's body, the valve having a plurality of movable leaflets, the leaflets having a superior surface on a first side and an inferior surface on an opposing side, the method comprising:
 positioning a coapting device near the valve, the coapting device having a pair of movable arms and a pair of superior elements adapted to engage the superior surface of the leaflets,   engaging the inferior surfaces of the leaflets with the arms;   capturing the leaflets between the movable arms and the superior elements;   manipulating the arms to hold the leaflets in a coapted position in which at least portions of the superior surfaces face each other;   removing the superior elements from the leaflets prior to permanently implanting the coapting device; and   implanting the coapting device permanently in engagement with the leaflets so as to maintain the leaflets in the coapted position.   
     
     
         2 . The method of  claim 1 , further comprising engaging the superior surfaces of the leaflets with the superior elements before moving the arms to a closed position. 
     
     
         3 . The method of  claim 1 , wherein the arms are disposed in a delivery position during positioning of the coapting device near the valve, and further comprising spreading the arms from the delivery position to the open position after the positioning step. 
     
     
         4 . The method of  claim 1 , wherein the coapting device is releasably coupled to a flexible shaft adapted for positioning through a blood vessel, and wherein the coapting device is implanted by releasing the coapting device from the flexible shaft. 
     
     
         5 . The method of  claim 4 , wherein the flexible shaft is slidably positioned through a sheath disposed in the blood vessel. 
     
     
         6 . The method of  claim 1 , wherein the leaflets are not penetrated by the arms. 
     
     
         7 . The method of  claim 1 , wherein the valve is in the patient's heart. 
     
     
         8 . The method of  claim 7 , wherein the valve is the mitral valve. 
     
     
         9 . The method of  claim 8 , wherein the positioning the coapting device comprises introducing the coapting device through the interatrial septum into the left atrium. 
     
     
         10 . A method of repairing a valve in a patient's body, the valve having a plurality of movable leaflets, the method comprising:
 positioning a coapting device near the valve, the coapting device having a grasping element and a pair of superior elements;   atraumatically grasping the leaflets with the grasping element to at least partially immobilize the leaflets relative to each other;   atraumatically engaging superior surfaces of the leaflets with the superior elements;   removing the superior elements from the leaflets prior to permanently implanting the coapting device; and   implanting the coapting device permanently in the patient's body, wherein the leaflets are not penetrated by the coapting device.   
     
     
         11 . The method of  claim 10 , wherein the grasping element has a pair of opposing non-penetrating surfaces for pinching the leaflets therebetween. 
     
     
         12 . The method of  claim 11 , wherein the grasping element has a pair of movable jaws, the non-penetrating surfaces being disposed on the movable jaws. 
     
     
         13 . The method of  claim 10 , wherein the leaflets have a superior surface on a first side thereof and an inferior surface on an opposing side thereof, and wherein the grasping element atraumatically engages the inferior surfaces of the leaflets. 
     
     
         14 . The method of  claim 13 , wherein the coapting device is implanted with at least portions of the superior surfaces of the leaflets generally facing each other. 
     
     
         15 . The method of  claim 13 , wherein the grasping element comprises a pair of movable arms, wherein the leaflets are immobilized by engaging the inferior surfaces and pinching the leaflets together with the movable arms. 
     
     
         16 . The method of  claim 10 , further comprising applying energy to the leaflets before implanting the coapting device. 
     
     
         17 . The method of  claim 16 , wherein the energy is applied to fuse at least portions of the leaflets together. 
     
     
         18 . The method of  claim 10 , wherein the valve is in the heart. 
     
     
         19 . The method of  claim 18 , wherein the valve is the mitral valve. 
     
     
         20 . The method of  claim 19 , wherein positioning the coapting device comprises introducing the coapting device through interatrial septum into the left atrium. 
     
     
         21 . The method of  claim 18 , wherein positioning the coapting device comprises endovascularly positioning the coapting device through a blood vessel into the heart. 
     
     
         22 . A method of repairing a valve in a patient's body, the valve having a plurality of movable leaflets, the method comprising:
 atraumatically grasping the leaflets with a coapting device, the coapting device having a grasping element and a pair of superior elements;   immobilizing at least a portion of the leaflets between the grasping element and the superior elements so that the leaflets are immobilized relative to each other;   fastening the leaflets together without penetrating the leaflets; and   removing the superior elements from the leaflets.   
     
     
         23 . The method of  claim 22 , wherein fastening the leaflets comprises applying a clip to the leaflets. 
     
     
         24 . The method of  claim 22 , wherein fastening the leaflets comprises delivering energy to the leaflets. 
     
     
         25 . The method of  claim 24 , wherein the energy is selected from radiofrequency, laser, microwave, or ultrasonic energy. 
     
     
         26 . The method of  claim 22 , wherein the grasping, immobilizing and fastening of the leaflets is performed using endovascular devices. 
     
     
         27 . The method of  claim 22 , wherein grasping, immobilizing and fastening of the leaflets is performed using the same device. 
     
     
         28 . The method of  claim 27 , wherein the device is implantable. 
     
     
         29 . The method of  claim 22 , wherein the valve is in the heart. 
     
     
         30 . The method of  claim 29 , wherein the valve is the mitral valve.