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Implantable valve and method

  • US 10,492,910 B2
  • Filed: 06/30/2016
  • Issued: 12/03/2019
  • Est. Priority Date: 10/13/2015
  • Status: Active Grant
First Claim
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1. Implantable valve for treating venous insufficiency of a vein, comprising:

  • a. an expandable scaffold having a distal section for blood in-flow, a center section and a proximal section for blood out-flow;

    b. said center section comprising an enlarged, non-circular and transversely symmetrical bulbous section having distal and proximal ends, said bulbous section, at its distal end, being wider than the vein in a front view and about as wide as the vein in a side view, said bulbous section tapering from its distal end towards said proximal section;

    c. said scaffold being embedded in a biocompatible polymer forming a frame which maintains the shape of said valve during opening and closing thereof, said frame having smooth inner and outer polymer walls throughout the distal, center and proximal sections;

    d. an inner-valve surrounded by and smoothly joined to said frame comprising;

    (i) at least two biocompatible polymeric leaflets having proximal ends transverse to the side view width of said bulbous section forming a valve outlet which opens and closes in response to venous blood flow, (ii) said leaflets having distal portions molded of one continuous polymer with the inner polymer wall of said bulbous section at its distal end such that the distal portions of said leaflets are smoothly joined to the inner polymer wall of said bulbous section, and (iii) said leaflets defining a biomimetic sinus region with said bulbous section; and

    e. wherein opening and closing of the valve induces predominantly biomimetic flushing of blood from said sinus region for smooth non-traumatic blood flow through said valve.

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