Prosthetic Tricuspid Valve Replacement Design

Abstract

A prosthetic heart valve may include a stent, a valve assembly disposed within the stent, a flange, and a plurality of anchor arms coupled to the stent. The stent may have collapsed and expanded conditions and inflow and outflow ends. The flange may include a plurality of braided wires and may be coupled to the stent and may be positioned adjacent the inflow end of the stent in the expanded condition of the stent. Each anchor arm may have a first end coupled to the stent adjacent the outflow end of the stent, a second end coupled to the stent adjacent the outflow end of the stent, and center portions extending from the first and second ends toward the inflow end of the stent. The center portions may be joined together to form a tip pointing toward the inflow end of the stent in the expanded condition of the stent.

1 . A prosthetic tricuspid heart valve, comprising:
 a stent having a collapsed condition, an expanded condition, an inflow end, and an outflow end;   a valve assembly disposed within the stent;   a flange comprising a plurality of braided wires, the flange being coupled to the stent and positioned adjacent the inflow end of the stent in the expanded condition of the stent; and   a plurality of anchor arms coupled to the prosthetic tricuspid heart valve, each anchor arm having a first end coupled to the prosthetic tricuspid heart valve adjacent to the inflow end of the stent, a second end coupled to the prosthetic tricuspid heart valve adjacent to the inflow end of the stent, and elongated center portions extending from the first and second ends toward the outflow end of the stent, the elongated center portions being joined together and hooking backward to form a tip pointing toward the inflow end of the stent in the expanded condition of the stent.   
     
     
         2 . The prosthetic tricuspid heart valve of  claim 1 , wherein the stent includes a first plurality of cells arranged in a first circumferential row adjacent the inflow end of the stent, and a second plurality of cells arranged in a second circumferential row adjacent the outflow end of the stent. 
     
     
         3 . The prosthetic tricuspid heart valve of  claim 2 , wherein the first and second ends of each of the plurality of anchor arms are coupled to the stent. 
     
     
         4 . The prosthetic tricuspid heart valve of  claim 3 , wherein the first end of each of the plurality of anchor arms is coupled to a respective first cell in the first circumferential row, the second end of each of the plurality of anchor arms is coupled to a respective second cell in the first circumferential row, and for each of the plurality of anchor arms the first cell is circumferentially adjacent to the second cell. 
     
     
         5 . The prosthetic tricuspid heart valve of  claim 4 , wherein the first end of each of the plurality of anchor arms is coupled to an apex of the respective first cell, and the second end of each of the plurality of anchor arms is coupled to an apex of the respective second cell in the first circumferential row. 
     
     
         6 . The prosthetic tricuspid heart valve of  claim 1 , wherein the tip of each of the plurality of anchor arms is blunted. 
     
     
         7 . The prosthetic tricuspid heart valve of  claim 1 , wherein each of the plurality of anchor arms forms a gap between the tip and adjacent portions of the elongated center portions, the gap sized and shaped to receive a portion of a native tricuspid valve leaflet therein. 
     
     
         8 . The prosthetic tricuspid heart valve of  claim 1 , wherein the stent is formed integrally with the plurality of anchor arms. 
     
     
         9 . The prosthetic tricuspid heart valve of  claim 1 , wherein the plurality of anchor arms includes three anchor arms spaced at substantially equal intervals around a perimeter of the stent. 
     
     
         10 . The prosthetic tricuspid heart valve of  claim 1 , wherein each of the anchor arms is at least partially covered by a first layer of material. 
     
     
         11 . The prosthetic tricuspid heart valve of  claim 1 , wherein the first and second ends of each of the plurality of anchor arms are coupled to the flange. 
     
     
         12 . The prosthetic tricuspid heart valve of  claim 1 , wherein the flange is coupled to the stent by coupling tubes positioned adjacent the inflow end of the stent. 
     
     
         13 . The prosthetic tricuspid heart valve of  claim 12 , wherein the coupling tubes include barbs having tips that extend radially away from a center longitudinal axis of the stent, and the barbs curve away from the outflow end of the stent. 
     
     
         14 . The prosthetic tricuspid heart valve of  claim 1 , wherein the flange includes a first surface adapted to contact a portion of a native valve annulus of a patient when the prosthetic tricuspid heart valve is in an implanted condition, and a second surface opposite the first surface. 
     
     
         15 . The prosthetic tricuspid heart valve of  claim 14 , further comprising a strip of material coupled to the prosthetic tricuspid heart valve, the strip of material extending around a perimeter of the stent adjacent to the inflow end of the stent. 
     
     
         16 . The prosthetic tricuspid heart valve of  claim 15 , wherein the strip of material includes a first edge coupled to the first surface of the flange, and a second edge opposite the first edge, the second edge being positioned nearer a center longitudinal axis of the stent than is the first edge in the expanded condition of the stent, the second edge being coupled to the first surface of the flange at intermittent locations spaced apart from each other. 
     
     
         17 . The prosthetic tricuspid heart valve of  claim 16 , wherein the first edge is substantially continuously coupled to the first surface of the flange so that at least one pocket is formed between the first strip of material and the first surface of the flange, the at least one pocket including a plurality of openings to the at least one pocket between the intermittent locations of attachment of the second edge to the first surface of the flange. 
     
     
         18 . The prosthetic tricuspid heart valve of  claim 17 , further comprising an intervening layer of material positioned between the strip of material and the first surface of the flange. 
     
     
         19 . The prosthetic tricuspid heart valve of  claim 15 , wherein the strip of material includes a first edge coupled to the first surface of the flange, and a second edge opposite the first edge, the second edge being positioned nearer a center longitudinal axis of the stent than is the first edge in the expanded condition of the stent, the second edge being coupled to the stent at intermittent locations spaced apart from each other. 
     
     
         20 . The prosthetic tricuspid heart valve of  claim 19 , wherein the first edge is substantially continuously coupled to the first surface of the flange so that at least one pocket is formed between the first strip of material and the first surface of the flange, the at least one pocket including a plurality of openings to the at least one pocket between the intermittent locations of attachment of the second edge to the stent.