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Devices, systems and methods for repairing lumenal systems

  • US 10,449,046 B2
  • Filed: 08/06/2014
  • Issued: 10/22/2019
  • Est. Priority Date: 09/22/2011
  • Status: Active Grant
First Claim
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1. A valvular prosthesis that is implantable over a native valve annulus, comprising:

  • a) a main circumferential frame, substantially covered by a curved membrane, having a supra annular frame portion and a sub annular frame portion, wherein, upon deployment into a native valve location, the supra annular frame portion rests above a valve annulus over a native valve leaflet and the sub annular frame portion extends downwardly;

    b) at least one deployable spring-loaded anchor attached to the main circumferential frame, wherein the at least one deployable anchor includes;

    an elongate body formed from a nickel-titanium alloy shape memory wire material formed into an elongate loop having a first end and a second free end, the free end having a rounded tip, and being configured to rest against native cardiac tissue; and

    at least one coil-shaped stress relief loop formed from said nickel-titanium alloy shape memory wire connecting the main circumferential frame to the first end of the elongate body, said at least one coil-shaped stress relief loop being configured and arranged to urge said elongate body to swing outwardly along an arcuate path about said at least one coil-shaped stress relief loop toward native cardiac tissue, wherein said at least one coil-shaped stress relief loop is configured to deflect and absorb bending stress along its length when said elongate body is forced inwardly to permit said elongate body of said at least one deployable anchor to be fully collapsed without fracturing said nickel-titanium alloy shape memory wire;

    c) at least one guiding tether, wherein said at least one coil-shaped stress relief loop is configured and arranged to serve as a guide eyelet configured and arranged to receive the at least one guiding tether, and wherein said at least one guiding tether is configured and arranged such that when received by the at least one coil-shaped stress relief loop, said at least one guiding tether can hold the at least one deployable anchor in an undeployed position;

    d) a plurality of counter fixation retainers disposed on the supra annular frame portion of the prosthesis, wherein at least two of the counter fixation retainers are configured and arranged to engage a native tissue wall proximate opposing native commissures,wherein the prosthesis is configured and arranged to expand outwardly toward the commissures of the valve during implantation and is configured and arranged to self-align in the valve opening.

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