Methods and devices for improving cardiac function in hearts

Abstract

Various methods and devices are disclosed for improving cardiac function in hearts having zones of infarcted (akinetic) and aneurysmal (dyskinetic) tissue regions. The methods and devices reduce the radius of curvature in walls of the heart proximal infarcted and aneurysmal regions to reduce wall stress and improve pumping efficiency. The inventive methods and related devices include splinting of the chamber wall proximal the infarcted region and various other devices and methods including suture and patch techniques.

1 - 77 . (canceled)  
     
     
         78 . A device for treating mitral valve regurgitation, comprising: 
 a tether;    a distal anchoring member positioned adjacent to a distal end of the tether; and    a proximal anchoring member positioned adjacent to a proximal end of the tether; wherein at least one of the anchoring members includes an elastic portion that flexes when the tensioning device is positioned across a chamber of a heart.    
     
     
         79 . The device of  claim 78  wherein the elastic portion comprises a material selected from a group consisting of a titanium alloy, stainless steel, a biocompatible shape-memory material, a biocompatible superelastic material, and a combination thereof.  
     
     
         80 . The device of  claim 78  wherein the elastic portion comprises a plurality of flexible arm segments.  
     
     
         81 . The device of  claim 80  wherein the flexible arm segments of at least one of the anchoring members self-expand adjacent the surfaces of a wall of a chamber of a heart.  
     
     
         82 . The device of  claim 78  wherein the tether comprises a material selected from a group consisting of stainless steel, titanium, a nickel-titanium alloy, urethane, polytetrafluoroethylene (PTFE), a flexible and strong biocompatible material, and a combination thereof.  
     
     
         83 . The device of  claim 78  wherein at least a portion of the tether has a helical configuration.  
     
     
         84 . The device of  claim 78  further comprising: at least one sealing member.  
     
     
         85 . The device of  claim 78  wherein at least a portion of the tensioning device includes a therapeutic agent selected from a group consisting of an antithrombotic, an anticoagulant, an antibiotic, an anti-inflammatory, and a combination thereof.  
     
     
         86 . An implant system to affect a shape of a heart valve annulus comprising a first component sized and configured to engage tissue along a major axis of the annulus and a second component sized and configured, concurrent with the first component, to engage and inwardly displace tissue along a minor axis of the annulus.  
     
     
         87 . An implant system according to  claim 86 , wherein the first component is sized and configured to inwardly displace tissue along the major axis.  
     
     
         88 . An implant system according to  claim 86 , wherein the first component is sized and configured to stabilize tissue along the major axis.  
     
     
         89 . An implant system according to  claim 86 , wherein the first and second components comprise separate components.  
     
     
         90 . An implant system according to  claim 86 , wherein the first and second components comprise an integrated body.  
     
     
         91 . An implant according to  claim 86 , wherein the first component is sized and configured to engage tissue while in compression.  
     
     
         92 . An implant system according to  claim 86 , wherein the first component includes a fixation element that engages tissue at, near, or in a leaflet commissure of the annulus.  
     
     
         93 . An implant system according to  claim 86 , wherein the second component includes a fixation element that engages tissue at, near, or in the annulus.  
     
     
         94 . A device for treating tissue near a valve to modify flow through the valve, comprising: 
 an elongate body having a central region and at least two anchoring regions on opposing end portions of the central region, wherein each anchoring region is configured to be anchored to opposing areas of tissue against or adjacent to an annulus of the valve and urge the areas of tissue towards one another;    the elongate body being further configured for delivery through a catheter to the tissue whereby the elongate body has a first shape during the delivery and a second shape after the delivery.    
     
     
         95 . The device of  claim 94  wherein the valve comprises a cardiac valve.  
     
     
         96 . The device of  claim 94  wherein the central region comprises a continuous alternating length.  
     
     
         97 . The device of  claim 94  wherein each of the anchoring regions comprise a fastener.  
     
     
         98 . The device of  claim 94  the elongate body being interwoven such that a plurality of spaces are defined therebetween in the second shape.  
     
     
         99 . The device of  claim 94  further comprising a biocompatible fastener for attaching each of the anchoring regions to the tissue.  
     
     
         100 . The device of  claim 99  wherein the biocompatible fastener comprises a distal end and a proximal end, the proximal end defining a projection for securing the anchoring region, and the distal end being configured for attachment to the tissue.  
     
     
         101 . The device of  claim 94  wherein each of the anchoring regions is biased towards the central region.  
     
     
         102 . The device of  claim 94  wherein the elongate body comprises Nickel-Titanium alloy.  
     
     
         103 . The device of  claim 94  wherein the elongate body is at least partially coated with a coating layer.  
     
     
         104 . The device of  claim 94  wherein the catheter comprises an elongate tubular member having a distal end and a proximal end with a lumen therebetween, the distal end defining a delivery port configured to pass the elongate body therethrough.  
     
     
         105 . The device of  claim 104  wherein the catheter further comprises a stylet having a distal end and a proximal end with a length therebetween, the stylet being slidingly disposed in the lumen and being manipulatable from its proximal end.  
     
     
         106 . The device of  claim 105  wherein the stylet distal end is angled.  
     
     
         107 . The device of  claim 105  wherein the catheter further comprises a linear advancement mechanism connected to the proximal end of the stylet.  
     
     
         108 . A method for treating tissue near a valve to modify flow through the valve, comprising: 
 providing an elongate body having a central region, a first anchoring region, and a second anchoring region, each of the anchoring regions being attached to opposing end portions of the central region;    placing a delivery catheter near the tissue;    urging the elongate body through a distal opening defined in the catheter such that the first anchoring region exits the distal opening and attaches to a first area of the tissue against or adjacent to an annulus of the valve; and    further urging the elongate body through the distal opening such that the second anchoring region exits the distal opening and attaches to a second area of the tissue against or adjacent to the annulus of the valve such that the first area and the second area are urged towards one another by the elongate body.    
     
     
         109 . The method of  claim 108  wherein the valve comprises a cardiac valve.  
     
     
         110 . The method of  claim 108  further comprising providing a biocompatible fastener for attaching the first and the second anchoring regions to the first and the second areas of tissue.  
     
     
         111 . The method of  claim 108  wherein the elongate body is comprised of a shape memory alloy.  
     
     
         112 . The method of  claim 111  wherein the shape memory alloy comprises Nickel-Titanium alloy.  
     
     
         113 . The method of  claim 108  wherein the first anchoring region forms a shape configured for attachment to the first area of the tissue upon exiting the distal opening.  
     
     
         114 . The method of  claim 108  wherein the second anchoring region forms a shape configured for attachment to the second area of the tissue upon exiting the distal opening.  
     
     
         115 . The method of  claim 108  wherein the first area and the second area are located about 180 degrees apart.  
     
     
         116 . The method of  claim 108  wherein urging the elongate body through the distal opening defined in the catheter comprises advancing a stylet having a distal end and a proximal end with a length therebetween through the delivery catheter.  
     
     
         117 . The method of  claim 116  wherein the stylet distal end is angled.  
     
     
         118 . The method of  claim 116  wherein the stylet is advanced by a linear advancement mechanism connected at the proximal end of the stylet.