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Thrombus management and structural compliance features for prosthetic heart valves

  • US 9,597,181 B2
  • Filed: 12/21/2015
  • Issued: 03/21/2017
  • Est. Priority Date: 06/25/2013
  • Status: Active Grant
First Claim
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1. A prosthetic heart valve comprising:

  • an outer frame assembly having an atrium portion configured to be disposed in an atrium of a heart, an opposite, ventricle portion, and an annulus portion between the atrium portion and the ventricle portion,the atrium portion having a maximum perimeter larger than a maximum perimeter of the annulus portion,the ventricle portion having a minimum perimeter smaller than a minimum perimeter of the annulus portion,the annulus portion having an hourglass shape with a minimum perimeter disposed between a larger perimeter near the atrium portion and a larger perimeter near the ventricle portion;

    an inner valve assembly, the inner valve assembly including an inner frame having an atrium end and a ventricle end, the inner valve assembly disposed within and coupled to the outer frame assembly by a connection between the ventricle end of the inner frame and the ventricle portion of the outer frame assembly,the inner frame assembly extending from the connection towards the atrium portion of the outer frame assembly, the inner frame assembly and the outer frame assembly diverging from the connection towards the atrium portion of the outer frame assembly,the inner valve assembly and the outer frame assembly defining therebetween an annular region, the inner valve assembly and the outer frame assembly configured to substantially prevent blood flow therebetween through the annular region,the annulus portion of the outer frame assembly being spaced radially from the inner valve assembly and radially inwardly deflectable towards the inner valve assembly to accommodate in the annulus portion a natural valve annulus having a perimeter smaller than the minimum perimeter of the annulus portion; and

    a pocket closure coupled between the outer frame assembly and the inner valve assembly and enclosing therewith a portion of the annular space, forming a thrombus retaining pocket, at least a portion of the pocket closure formed of a material having a porosity that is sufficiently large to allow red blood cells to pass through the pocket closure into the pocket and that is sufficiently small to prevent thrombus formed from the red blood cells to pass through the pocket closure from the thrombus retaining pocket.

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