Minnimally invasive device for treating chronic heart failure

Abstract

A device for treating chronic heart failure made of a construct composed of cardiac tissue and a frame supporting the construct. The frame has a plurality of elongated members and the cardiac tissue is attached to the elongated members. The elongated members extend outwardly from a converging region and diverge to provide a distal opening and a space proximal of the distal opening between the elongated members, the space dimensioned to fit over a heart of the patient to treat chronic heart failure.

1 . A device for treating chronic heart failure comprising a three dimensional construct forming a scaffold composed of cardiac tissue and a frame supporting the construct, the frame comprising a plurality of elongated members and the construct attached to the elongated members, wherein the frame is movable from a first non-expanded position for delivery in a space between a vertebrae of a patient and a second expanded position for placement around a heart of the patient when exposed from an insertion sheath, the elongated members extending parallel to a longitudinal axis of the device in the non-expanded position, wherein the device automatically moves to the second expanded position when exposed from the insertion sheath, the elongated members extending outwardly from a converging region and diverging to provide a distal opening and a space between the elongated members proximal of the distal opening, the space dimensioned to fit over a heart of the patient to treat chronic heart failure, the elongated members extending distally from the converging region to the distal opening and attached to a delivery element at the converging region, the elongated members being flexible to conform to the shape of the heart. 
     
     
         2 . The device of  claim 1 , wherein the frame is composed of shape memory metal. 
     
     
         3 . The device of  claim 1 , wherein the frame has a plurality of tines which engage cardiac tissue to retain the frame around the heart. 
     
     
         4 . The device of  claim 1 , wherein the elongated members of the frame are composed of a plurality of wires. 
     
     
         5 . The device of  claim 1 , wherein the elongated members of the frame are composed of a plurality of struts. 
     
     
         6 . The device of  claim 1 , wherein the converging region includes a connection structure for releasable connection to the delivery element. 
     
     
         7 . The device of  claim 6 , wherein the connection structure comprises a threaded engagement with the delivery element. 
     
     
         8 . The device of  claim 1 , wherein the frame is movable from a first non-expanded position for delivery in a space between a vertebrae of the patient and a second expanded position for placement around the heart. 
     
     
         9 . (canceled) 
     
     
         10 . The device of  claim 1 , wherein the elongated members terminate in blunt atraumatic ends. 
     
     
         11 . A system for treating chronic heart failure of a patient comprising a delivery system and a device having a longitudinal axis and configured for positioning circumferentially around a heart of the patient, the device composed of a frame having a plurality of longitudinally extending elongated members and a three dimensional construct forming a scaffold made of cardiac tissue connected to the frame, the frame movable between a first position within a delivery member of the delivery system and a second expanded position when exposed from the delivery member, wherein the frame automatically moves to the expanded position when exposed from the insertion sheath, wherein in the first position the elongated members extend in a longitudinal direction, the delivery system further including an elongated delivery element carrying the device and detachably connected to a proximal region of the frame and positioned within the delivery member, wherein the frame has a plurality of penetrating members having sharp penetrating tips extending from the elongated members which engage cardiac tissue to retain the frame around the heart, the plurality of penetrating members spaced apart longitudinally along a length of the elongated members. 
     
     
         12 . The system of  claim 11 , wherein the delivery member is configured and dimensioned for positioning in an intercostal space for minimally invasive insertion of the device. 
     
     
         13 . The system of  claim 11 , wherein the plurality of elongated members diverge from a proximal region to provide an open space dimensioned to fit over the heart of the patient. 
     
     
         14 . The system of  claim 11 , wherein the elongated members are attached at proximal ends via threaded engagement to the delivery element, and the delivery element is rotatable to detach the delivery element from the frame. 
     
     
         15 . (canceled) 
     
     
         16 . The system of  claim 1 , wherein the construct is in the form of a patch, fabric or mesh. 
     
     
         17 . The system of  claim 1 , wherein the plurality of elongated members have an outer surface configured to directly contact tissue. 
     
     
         18 . The system of  claim 1 , wherein the elongated members diverge outwardly along a length and transition to regions extending parallel to a longitudinal axis of the frame. 
     
     
         19 . The system of  claim 11 , wherein the construct is in the form of a patch, fabric or mesh. 
     
     
         20 . The system of  claim 11 , wherein the plurality of elongated members have an outer surface configured to directly contact tissue. 
     
     
         21 . The system of  claim 11 , wherein the elongated members diverge outwardly along a length and transition to regions extending parallel to a longitudinal axis of the frame.