Physiologically harmonized tricuspid annuloplasty ring

Abstract

A prosthetic tricuspid remodeling annuloplasty ring having two free ends that are upturned in the inflow direction to help avoid unnecessary leaflet abrasion. The free ends are desirably separated across a gap that is large enough to reduce the risk of passing sutures through the conductive system of the heart, yet not too large that support of the septal leaflet of the tricuspid annulus is degraded. The tricuspid ring may have four sequential segments looking from the inflow side and extending in a clockwise direction from a free end located adjacent the antero septal commissure after implant. The ring may define an inflow bulge in the first segment and/or an inflow bulge in the fourth segment that help the ring conform to the natural bulges created by the adjacent aorta, thereby reducing stress and the potential for ring dehiscence. Desirably, the ring has variable flexibility, either gradual and/or between or within different segments, so as to adapt or harmonize its 3-dimensional shape to each individual patient and, therefore, to significantly reduce the constraints on the annulus and adjacent structures, particularly the leaflets and the conduction tissue.

1 . A prosthetic tricuspid annuloplasty ring, comprising:
 a ring body generally arranged in a plane and about an axis along an inflow-outflow direction, the ring body being discontinuous so as to define a first free end and a second free end separated across a gap, the two free ends being bent out of the plane in an inflow direction.   
   
   
       2 . The prosthetic tricuspid annuloplasty ring of  claim 1 , wherein the ring body defines a generally asymmetric ovoid shape and extends in a clockwise direction from a first free end located adjacent the antero-septal commissure when implanted, as seen looking at the inflow side thereof, around a first segment, a second segment, a third segment, and a fourth segment that terminates in the second free end at a septal point, and wherein the ring body has an arcuate bulge out of the plane toward the inflow side at the first segment to accommodate an anatomical bulge of the aorta into the tricuspid annulus. 
   
   
       3 . The prosthetic tricuspid annuloplasty ring of  claim 1 , wherein the ring body defines a generally asymmetric ovoid shape and extends in a clockwise direction from a first free end located adjacent the antero-septal commissure when implanted, as seen looking at the inflow side thereof, around a first segment, a second segment, a third segment, and a fourth segment that terminates in the second free end at a septal point, and wherein the ring body has an arcuate bulge out of the plane toward the inflow side at the fourth segment. 
   
   
       4 . The prosthetic tricuspid annuloplasty ring of  claim 1 , wherein the ring body defines a generally asymmetric ovoid shape and extends in a clockwise direction from a first free end located adjacent the antero-septal commissure when implanted, as seen looking at the inflow side thereof, around a first segment, a second segment, a third segment, and a fourth segment that terminates in the second free end at a septal point, and wherein the ring body has a varying flexibility and the fourth segment is relatively more flexible than the third segment. 
   
   
       5 . The prosthetic tricuspid annuloplasty ring of  claim 1 , wherein the ring body has a varying flexibility and is stiffer adjacent the first free end than adjacent the second free end. 
   
   
       6 . The prosthetic tricuspid annuloplasty ring of  claim 1 , wherein the ring body has a varying flexibility comprising at least one hinge point that is locally more flexible than adjacent segments. 
   
   
       7 . The prosthetic tricuspid annuloplasty ring of  claim 1 , wherein the ring has a long dimension in millimeters, and the free ends are separated by a distance of between about 40%-50% of the long dimension. 
   
   
       8 . The prosthetic tricuspid annuloplasty ring of  claim 1 , wherein the two free ends are each bent to have an axial height of between about 1-4 mm out of the plane. 
   
   
       9 . A prosthetic tricuspid annuloplasty ring having a long dimension in millimeters, comprising:
 an asymmetric generally ovoid ring body generally arranged in a plane and about an axis along an inflow-outflow direction and being discontinuous so as to define two free ends, the ring body having a length and shape such that if a first free end is implanted adjacent an antero septal commissure of the tricuspid annulus the ring body conforms to the tricuspid annulus and a second end is located adjacent a septal leaflet of the tricuspid annulus, and the free ends are separated across a gap having a dimension of between about 40%-50% of the long dimension.   
   
   
       10 . The prosthetic tricuspid annuloplasty ring of  claim 9 , wherein the ring body extends in a clockwise direction from the first free end, as seen looking at the inflow side thereof around a first segment, a second segment, a third segment, and a fourth segment that terminates in the second free end at a septal point, and wherein the ring body has an arcuate bulge out of the plane toward the inflow side at the first segment to accommodate an anatomical bulge of the aorta into the tricuspid annulus. 
   
   
       11 . The prosthetic tricuspid annuloplasty ring of  claim 9 , wherein the ring body extends in a clockwise direction from the first free end, as seen looking at the inflow side thereof, around a first segment, a second segment, a third segment, and a fourth segment that terminates in the second free end at a septal point, and wherein the ring body has an arcuate bulge out of the plane toward the inflow side at the fourth segment. 
   
   
       12 . The prosthetic tricuspid annuloplasty ring of  claim 9 , wherein the ring body has a varying flexibility and is stiffer adjacent the first free end than adjacent the second free end. 
   
   
       13 . The prosthetic tricuspid annuloplasty ring of  claim 9 , wherein the ring body has a varying flexibility comprising at least one hinge point that is locally more flexible than adjacent segments. 
   
   
       14 . A prosthetic tricuspid annuloplasty ring, comprising:
 an asymmetric generally ovoid ring body generally arranged in a plane and about an axis along an inflow-outflow direction with a first free end located adjacent an antero-septal commissure when implanted and a second free end located at a septal point, wherein the ring body extends in a clockwise direction as seen looking at an inflow side from the first free end around a first segment a second segment, a third segment, and a fourth segment that terminates in the second free end, and wherein the ring body has an arcuate bulge out of the plane toward the inflow side at the first segment so as to accommodate an anatomical bulge of the aorta into the tricuspid annulus.   
   
   
       15 . The prosthetic tricuspid annuloplasty ring of  claim 14 , wherein the ring body an arcuate bulge out of the plane toward the inflow side at the fourth segment. 
   
   
       16 . The prosthetic tricuspid annuloplasty ring of  claim 14 , wherein the ring body has a varying flexibility and is stiffer adjacent the first free end than adjacent the second free end. 
   
   
       17 . The prosthetic tricuspid annuloplasty ring of  claim 16 , wherein the ring body has a varying flexibility comprising at least one hinge point that is locally more flexible than adjacent segments. 
   
   
       18 . A prosthetic tricuspid annuloplasty ring, comprising:
 an asymmetric generally ovoid ring body generally arranged in a plane and about an axis along an inflow-outflow direction with a first free end located adjacent an antero-septal commissure when implanted and a second free end located at a septal point, wherein the ring body extends in a clockwise direction as seen looking at an inflow side from the first free end around a first segment, a second segment, a third segment, and a fourth segment that terminates in the second free end, and wherein the ring body has a variable flexibility comprising at least one hinge point that is locally more flexible than adjacent segments.   
   
   
       19 . The prosthetic tricuspid annuloplasty ring of  claim 18 , wherein the hinge point is located at the approximate midpoint of the ring body. 
   
   
       20 . The prosthetic tricuspid annuloplasty ring of  claim 18 , wherein there are two hinge points located approximately diametrically opposite one another so that the ring flexes generally in a plane.