Methods and devices for capturing and fixing leaflets in valve repair

Abstract

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

What is claimed is: 
     
         1 . A device for repairing a cardiac valve, said device comprising:
 an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; and   a capture device on the interventional catheter comprising at least one distal element coupled to the catheter, wherein the distal element is protrudable radially outward and is adapted to press against a downstream surface of at least one leaflet,   wherein the capture device fixedly couples the valve leaflet to a second valve leaflet; and   a pledget adjacent the distal element, the pledget adapted to obstruct blood flow through a gap created by the device along a coaptation line between the at least one leaflet and a second leaflet.   
     
     
         2 . The device of  claim 1 , wherein the pledget is disk shaped. 
     
     
         3 . The device of  claim 1 , further comprising at least one proximal element disposed proximal to the distal element. 
     
     
         4 . The device of  claim 3 , wherein the proximal element is protrudable radially outward. 
     
     
         5 . The device of  claim 3 , wherein the pledget is positioned between the proximal and distal elements. 
     
     
         6 . The device of  claim 3 , wherein the at least one leaflet is captured between the proximal and distal elements. 
     
     
         7 . A device for repairing a cardiac valve, said device comprising:
 an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; and   a capture device on the interventional catheter comprising at least one distal element coupled to the catheter, wherein the distal element comprises a block protrudable radially outward and is adapted to engage and press against a downstream surface of at least one leaflet,   wherein the interventional catheter further comprises at least one fixation tool for fixing the valve leaflet to a second valve leaflet, and   the fixation tool comprising a penetrating device which has a suture and an anchor coupled with the suture.   
     
     
         8 . The device of  claim 7 , wherein the block is adapted to pivot about a pivot point. 
     
     
         9 . The device of  claim 7 , wherein the block is a rod shaped or bar shaped. 
     
     
         10 . The device of  claim 7 , wherein the catheter has a diameter and the distal element extends beyond the diameter. 
     
     
         11 . The device of  claim 8 , further comprising a pull wire coupled to the block, the pull wire adapted to pivot the block about the pivot point. 
     
     
         12 . The device of  claim 8 , wherein the distal element is pivotable about the pivot point to a position substantially perpendicular to the catheter. 
     
     
         13 . The device of  claim 7 , wherein the block has one or more cutouts therein and the block is surrounded by one or more wire-like loops. 
     
     
         14 . The device of  claim 13 , wherein the loops are adjustable thereby changing the engagement between the loops and downstream surface of the leaflet. 
     
     
         15 . The device of  claim 7 , further comprising a second distal element coupled to the catheter and adapted to press against a downstream surface of at least a second leaflet. 
     
     
         16 . The device of  claim 15 , wherein the first distal element is independently movable relative to the second distal element. 
     
     
         17 . The device of  claim 15 , wherein the first distal element is extendable independently of the second distal element. 
     
     
         18 . The device of  claim 15 , wherein the first distal element has a first angle of curvature and the second distal element has a second angle of curvature different than the first. 
     
     
         19 . The device of  claim 7 , further comprising a cap near a distal end of the capture device. 
     
     
         20 . The device of  claim 19 , wherein the cap has a blunt surface that facilitates atraumatic advancement of the capture device through the valve. 
     
     
         21 . The device of  claim 7 , wherein moving the cap proximally toward the distal element facilitates grasping of the valve leaflet between the distal element and a distal end of the interventional catheter. 
     
     
         22 . The device of  claim 7 , wherein the cap is positionable proximally toward the distal element thereby increasing the rigidity of the distal element. 
     
     
         23 . A device for repairing a cardiac valve, said device comprising:
 an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; and   a capture device on the interventional catheter comprising at least one distal element and one proximal element coupled to the catheter, wherein the distal element is protrudable radially outward and adapted to press against a downstream surface of at least one leaflet and the proximal element is adapted to press against an upstream surface of the at least one leaflet.   
     
     
         24 . The device of  claim 23 , wherein the proximal and distal elements are formed by a continuous structure. 
     
     
         25 . The device of  claim 23 , wherein the proximal and distal elements are formed from a wire-like filament. 
     
     
         26 . The device of  claim 23 , wherein the proximal and distal elements are expandable into loops. 
     
     
         27 . The device of  claim 23 , wherein the proximal and distal elements are collapsible into a helical shape. 
     
     
         28 . A method for repairing a cardiac valve having valve leaflets, the method comprising:
 accessing a patient's vasculature remote from the heart;   advancing a catheter having a capture device in an antegrade direction into the right atrium of the heart and to a location near the cardiac valve, wherein the capture device comprises at least one distal element adapted to independently protrude radially outward from the catheter;   capturing at least one leaflet with the capturing device by atraumatically pressing the at least one distal element against the leaflet;   repositioning the captured leaflets independently of each other by applying an upward force against a downstream surface of each leaflet; and   fixing the leaflets together.   
     
     
         29 . The method of  claim 28 , wherein advancing the catheter comprises advancing the catheter through the inferior vena cava or the superior vena cava. 
     
     
         30 . The method of  claim 28 , wherein advancing the catheter comprises advancing the catheter across an interatrial septum. 
     
     
         31 . The method of  claim 30 , wherein advancing the catheter comprises advancing the catheter into a left atrium of the patient's heart. 
     
     
         32 . The method of  claim 30 , wherein advancing the catheter across an interatrial septum comprises piercing the interatrial septum with a needle. 
     
     
         33 . The method of  claim 28 , wherein the cardiac valve is a mitral valve. 
     
     
         34 . The method of  claim 28 , further comprising advancing a second catheter in a retrograde direction adjacent to the location. 
     
     
         35 . A method for repairing a cardiac valve having valve leaflets, the method comprising:
 accessing a patient's vasculature remote from the heart;   advancing a catheter having a capture device in a retrograde direction into the left ventricle of the heart and to a location near the cardiac valve, wherein the capture device comprises at least one distal element adapted to independently protrude radially outward from the catheter;   capturing at least one leaflet with the capturing device by atraumatically pressing the at least one distal element against the leaflet;   repositioning the captured leaflets independently of each other by applying an upward force against a downstream surface of each leaflet; and   fixing the leaflets together.   
     
     
         36 . The method of  claim 35 , wherein advancing the catheter comprises advancing the catheter through an aortic arch. 
     
     
         37 . The method of  claim 35 , wherein advancing the catheter comprises advancing the catheter across an aortic valve. 
     
     
         38 . The method of  claim 35 , wherein advancing the catheter comprises advancing the catheter into a left atrium of the heart. 
     
     
         39 . The method of  claim 35 , wherein the cardiac valve is a mitral valve. 
     
     
         40 . The method of  claim 35 , further comprising advancing a second catheter in antegrade direction adjacent to the location.