| CPC A61F 2/2466 (2013.01) [A61F 2/2448 (2013.01)] | 22 Claims |
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1. A method of aligning an annuloplasty ring with at least one natural fiducial in an annular target, implementable in a system comprising:
an annuloplasty ring having an outer hollow tube, or a toroidal portion thereof with a plurality of segments, operable to change the outer hollow tube from an insertion configuration to an operable configuration;
an alignment member, releasably coupled to the outer hollow tube via at least one coupling assembly, the at least one coupling assembly configured to be aligned with the at least one natural fiducial; and
a delivery catheter adapted, sized, and configured to accommodate: the alignment member and the annuloplasty ring in the insertion configuration, wherein the delivery catheter is operable, once the annuloplasty ring is inserted, to alter the outer hollow tube from the insertion configuration to the operable configuration, the method comprising:
using the delivery catheter, introducing the annuloplasty ring or the toroidal portion to the annular target;
using the delivery catheter, altering the insertion configuration of the annuloplasty ring or the toroidal portion to the operable configuration; and
using the alignment member, aligning the at least one coupling assembly with the at least one natural fiducial, thereby aligning the annuloplasty ring or the toroidal portion with the at least one natural fiducial in the annular target,
wherein the at least one natural fiducial is a right fibrous trigon, a left fibrous trigon, a interleaflet triangle, a tricuspid posterior-anterior hinge, or a combination comprising one or more of the foregoing,
wherein the alignment member comprises a pair of stylets, each stylet having a distal eyelet, releasably coupled to the outer hollow tube via the at least one coupling assembly, wherein the at least coupling assembly is coupled to the alignment member in the distal eyelet,
wherein using the aligning member comprises aligning at least one of the coupling assemblies with at least one of the at least one natural fiducials,
wherein each coupling assembly comprises:
a fin defining a longitudinal axis, transversely coupled to the outer hollow tube, having an arcuate apical surface abutting the outer hollow tube, and a fin body extending basally from the arcuate apical surface, defining a pair of drill holes, each drill hole sized and configured to accommodate a release cord; and
a brace, having an apical end defining a pair of flanged protrusions extending apically, wherein the flanges extend laterally from each flanged protrusion, with a gap between the flanged protrusions, the gap having a width sized and configured to accommodate a width of the fin body, and a basal end defining an aperture in parallel with the longitudinal axis of the fin, sized and configured to receive and accommodate the distal eyelet portion of each stylet, and
wherein the fin is sandwiched between the pair of flanged protrusions, engaged via a pair of release cords included in the delivery catheter and looped through a corresponding drill hole of the pair of drill holes defined in the fin body, below the laterally extending flange of the flanged protrusions, the pair of release cords configured to releasably couple the brace to the fin.
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