Shape memory devices and methods for reshaping heart anatomy

Abstract

Systems, methods and devices are provided for treating heart failure patients suffering from various levels of heart dilation. Such heart dilation is treated by reshaping the heart anatomy with the use of shape memory elements. Such reshaping changes the geometry of portions of the heart, particularly the right or left ventricles, to increase contractibility of the ventricles thereby increasing the stroke volume which in turn increases the cardiac output of the heart. The shape memory elements have an original shape and at least one memory shape. The elements are implanted within the heart tissue or attached externally and/or internally to a surface of the heart when in the original shape. The elements are then activated to transition from the original shape to one of the at least one memory shapes. Transitioning of the elements cause the associated heart tissue areas to readjust position, such as to decrease the width of the ventricles. Such repositioning is maintained over time by the elements, allowing the damaging effects of heart dilation to slow in progression or reverse.

1 . A device for reshaping heart anatomy comprising:
 a shape memory element which is transitionable between an original shape and at least one memory shape, wherein the original shape is configured for at least partial implantation within a tissue area of the heart anatomy and the at least one memory shape is configured to apply force to the tissue area in a manner which reshapes the heart anatomy.   
   
   
       2 . A device as in  claim 1 , wherein the shape memory element undergoes a deformation of at least 50% in the transition. 
   
   
       3 . A device as in  claim 1 , wherein the transition substantially occurs within up to approximately 5-120 seconds. 
   
   
       4 . A device as in  claim 1 , wherein the at least one memory shape has a more curved configuration than the original shape. 
   
   
       5 . A device as in  claim 1 , wherein the tissue area is located within a wall of a ventricle and wherein the at least one memory shape is configured to apply force to the tissue area in a manner which reduces a width of the ventricle. 
   
   
       6 . A device as in  claim 1 , wherein the tissue area is located within the left atrium wall and wherein the at least one memory shape is configured to apply force to the tissue area in a manner which reshapes an annulus of a mitral valve. 
   
   
       7 . A device as in  claim 1 , wherein the shape memory element comprises at least one shape memory metal or metal alloy. 
   
   
       8 . A device as in  claim 7 , wherein the at least one shape memory metal or metal alloy exhibits a paramagnetic or ferromagnetic transition. 
   
   
       9 . A device as in  claim 8 , wherein the at least one shape memory metal alloy comprises Fe—C, Fe—Pd, Fe—Mn—Si, Co—Mn, Fe—Co—Ni—Ti, Ni 2 MnGa, Co—Ni—Al, Ni—Mn—Ga, or a combination of these. 
   
   
       10 . A device as in  claim 1 , wherein the shape memory element includes at least one coating or covering. 
   
   
       11 . A device as in  claim 10 , wherein the coating or covering comprises a biocompatible material. 
   
   
       12 . A method of reshaping heart anatomy comprising:
 providing a shape memory element which is transitionable between an original shape and at least one memory shape;   implanting the shape memory element having its original shape at least partially within a tissue area of the heart anatomy; and   activating the shape memory element causing transition from its original shape to one of the at least one memory shapes while the element is at least partially implanted, wherein the transition causes the tissue area to move in a manner which reshapes the heart anatomy.   
   
   
       13 . A method as in  claim 12 , wherein the tissue area is located within a wall of a ventricle and reshaping the heart anatomy comprises reducing a width of the ventricle. 
   
   
       14 . A method as in  claim 12 , wherein the shape memory element comprises at least one shape memory metal or metal alloy capable of exhibiting a paramagnetic or ferromagnetic transition and wherein activating comprises applying a magnetic field to the metal or metal alloy. 
   
   
       15 . A method as in  claim 12 , wherein implanting comprises positioning the shape memory element at least partially on a surface of the heart anatomy. 
   
   
       16 . A method as in  claim 15 , wherein implanting comprises stitching the shape memory element through the tissue area.