Cardiac Annulus Support Device

Abstract

An implantable cardiac annulus support device formed from a Nitinol stent frame that expands into contact with the annulus above the native leaflets. A torus balloon activates fixation elements along the perimeter to fasten the stent frame to native tissues of the heart valve near the native annulus. The stent frame reduces in perimeter to reduce the perimeter of the annulus. A cinch ring placed under tension can reduce the perimeter of the stent frame.

1 . A device deliverable via a transcatheter delivery catheter and implanted into native tissues of a heart valve along a perimeter of a native heart valve annulus to provide support to the native heart valve annulus, said device comprising:
 A. a stent frame that is self-expandable having a stent frame perimeter, said stent frame having a plurality of fixation elements attached thereto along said stent frame perimeter, said stent frame having an activating torus balloon attached along said stent frame perimeter,   B. said stent frame being expandable from an unexpanded configuration to an expanded configuration, said expanded configuration having an expanded stent frame perimeter configured to make contact with the native tissues of the heart valve,   C. said activating torus balloon having an activating balloon inflated configuration wherein said activating torus balloon is configured to provide an outward force onto said plurality of fixation elements thereby extending at least a portion of said plurality of fixation elements into an active configuration located on an outside region of said stent frame with said stent frame in said expanded configuration, and   D. said plurality of fixation elements being configured to attach said support frame to the native tissues of the heart valve to provide the support to the native heart valve annulus.   
     
     
         2 . The device of  claim 1  wherein said stent frame has an open central region along a central axis of said stent frame with said activating torus balloon being in said activating balloon inflated configuration, said open central region configured to provide passage for blood flow through said open central region. 
     
     
         3 . The device of  claim 1  wherein said stent frame has a cinch tube attached along said stent-frame perimeter, said cinch tube containing a tensioning fiber, said tensioning fiber configured to hold tension to cause a reduction in said stent frame perimeter, whereby said reduction in stent frame perimeter is configured to reduce the perimeter of the native heart valve annulus. 
     
     
         4 . The device of  claim 1  wherein said stent frame further has said expanded configuration while said activating torus balloon is in an activating balloon uninflated configuration and with said plurality of fixation elements in an inactive configuration on an inside luminal region of said stent frame, said inactive configuration for said plurality of fixation elements allowing said stent frame perimeter to be configured to make continuous contact with the perimeter of the native heart valve annulus. 
     
     
         5 . The device of  claim 1  wherein said stent frame has an equilibrium stent frame perimeter that is smaller than said expanded stent frame perimeter, said device further comprising an expansion torus balloon attached along said stent frame perimeter, said expansion torus balloon configured to apply an outward force onto said stent frame to cause said stent frame to expand to said expanded stent frame perimeter, said expanded stent frame perimeter configured to make contact with native tissues of the heart valve, 
     
     
         6 . The device of  claim 5  wherein said expansion torus balloon has an expansion balloon uninflated configuration with said fixation elements in said active configuration wherein said stent frame is configured to return from said expanded stent frame perimeter to said equilibrium stent frame perimeter whereby said fixation elements are therein configured to transmit an inward force from said stent frame onto the native tissues of the heart valve to reduce the perimeter of the native heart valve annulus. 
     
     
         7 . The device of  claim 1  wherein said stent frame has a plurality of backing members attached to said support frame and making contact with said activating torus balloon, said plurality of backing members providing support to said activating torus balloon such that inflation of said activating torus balloon is configured to generate the outward force to extend said at least a portion of said plurality of fixation elements outwards into said active configuration. 
     
     
         8 . The device of  claim 7  wherein said backing members are backing fibers, said backing fibers being formed from a flexible fiber material with a low bending force relative to said stent frame. 
     
     
         9 . The device of  claim 1  wherein at least a portion of said stent frame has a covering attached thereto, said covering configured to prevent passage of blood from a region inside of said stent frame to a region outside of said stent frame. 
     
     
         10 . The device of  claim 1  wherein said activating torus balloon is fixedly attached to said stent frame, said activating torus balloon configured to be implantable along with said stent frame. 
     
     
         11 . The device of  claim 5  wherein said expansion torus balloon is fixedly attached to said stent frame, said expansion torus balloon configured to be implantable along with said stent frame. 
     
     
         12 . The device of  claim 1  wherein said activating torus balloon is removably attached to said stent frame, said activating torus balloon configured to be removed from said stent frame prior to implantation of said device. 
     
     
         13 . The device of  claim 5  wherein said expansion torus balloon is removably attached to said stent frame, said expansion torus balloon configured to be removed from said stent frame prior to implantation of said device. 
     
     
         14 . The device of  claim 1  wherein said activating torus balloon is configured to be inflated with an inflation fluid which is allowed to leak out of said activating torus balloon following inflation of said activating torus balloon. 
     
     
         15 . The device of  claim 5  wherein said expansion torus balloon is configured to be inflated with an inflation fluid which is allowed to leak out of said expansion torus balloon following inflation of said expansion torus balloon. 
     
     
         16 . The device of  claim 1  wherein said activating torus balloon is inflated with an inflation medium that is retained within said torus balloon, said activating torus balloon having a valve attached thereto to retain said inflation medium within said activating torus balloon. 
     
     
         17 . The device of  claim 5  wherein said expansion torus balloon is inflated with an inflation medium that is retained within said expansion torus balloon, said expansion torus balloon having a valve attached thereto to retain said inflation medium within said expansion torus balloon. 
     
     
         18 . The device of  claim 3  wherein a cinch clasp attached to said cinch tube is configured to hold the tension in said tensioning fiber, said cinch fiber being releasably attached to a cinch cable that is configured to be tensioned by an operator of said device. 
     
     
         19 . A device deliverable via a transcatheter delivery catheter to a heart valve and implanted into native tissues of the heart valve, said device comprising:
 A. a self-expandable stent frame having a stent frame perimeter, said self-expandable stent frame having a plurality of fixation elements attached thereto along said stent frame perimeter, said self-expandable stent frame having a torus balloon attached along said stent frame perimeter,   B. said plurality of fixation elements having an active configuration with said plurality of fixation elements located on an outside region of said self-expandable stent frame,   C. said torus balloon having an inflated configuration configured to extend said plurality of fixation elements into said active configuration, and   D. said plurality of fixation elements configured to attach said self-expandable stent frame to the native tissues of the heart valve.   
     
     
         20 . A device deliverable via a transcatheter delivery catheter to native tissues of a heart valve along a perimeter of a native heart valve annulus, said device comprising:
 A. a stent frame that is self-expanding having a stent frame perimeter, said stent frame having a plurality of fixation elements attached thereto along said stent frame perimeter, said stent frame having a torus balloon attached along said stent frame perimeter,   B. said torus balloon having an inflated configuration configured to provide an outward force onto said plurality of fixation elements thereby extending said plurality of fixation elements into said active configuration located on an outside region of said stent frame in an expanded configuration with an expanded stent frame perimeter,   C. said plurality of fixation elements being configured to attach said stent frame to the native tissues of the heart valve, and   D. said stent frame having a tensioning fiber attached along said stent frame perimeter, said tensioning fiber being configured to be placed under tension to reduce said expanded stent frame perimeter.