Prosthetic valve with selectively positioned bioactive agent

Abstract

A prosthetic valve includes a support frame, a leaflet attached to the support frame, and a bioactive agent associated with the leaflet. A first free edge of the leaflet permits fluid flow through a body vessel in a first direction and substantially prevents fluid flow through the body vessel in a second, opposite direction. A second free edge of the leaflet at least partially defines an opening for permitting a controlled amount of fluid flow through the body vessel.

1 . A prosthetic valve for selectively permitting fluid flow through a body vessel, said prosthetic valve comprising:
 a support frame;   a leaflet attached to the support frame and having first and second free edges, the first free edge adapted to move between first and second positions and to permit said fluid flow through said body vessel in a first direction and substantially prevent said fluid flow through said body vessel in a second, opposite direction, the second free edge at least partially defining an opening for permitting a controlled amount of said fluid flow through said body vessel; and   a bioactive agent associated with the second free edge;   wherein the first free edge is free of the bioactive agent.   
   
   
       2 . The prosthetic valve of  claim 1 , wherein the second free edge entirely defines the opening. 
   
   
       3 . The prosthetic valve of  claim 1 , wherein the second free edge and a portion of the support frame define the opening. 
   
   
       4 . The prosthetic valve of  claim 1 , wherein the leaflet defines a flap capable of substantially covering the opening. 
   
   
       5 . The prosthetic valve of  claim 1 , wherein the leaflet comprises a bioremodellable material. 
   
   
       6 . The prosthetic valve of  claim 1 , wherein the leaflet comprises an extracellular matrix material. 
   
   
       7 . The prosthetic valve of  claim 1 , wherein the leaflet comprises small intestine submucosa. 
   
   
       8 . The prosthetic valve of  claim 1 , wherein the bioactive agent is adapted to prevent cellular deposition, cellular ingrowth, or cellular proliferation. 
   
   
       9 . The prosthetic valve of  claim 1 , wherein the bioactive agent comprises an antiproliferative agent. 
   
   
       10 . The prosthetic valve of  claim 9 , wherein the bioactive agent comprises paclitaxel. 
   
   
       11 . The prosthetic valve of  claim 1 , wherein the bioactive agent comprises an anti-inflammatory agent. 
   
   
       12 . The prosthetic valve of  claim 1 , wherein the bioactive agent comprises one or more of a thrombin inhibitor, an antithrombogenic agent, a thrombolytic agent, a fibrinolytic agent, an antimicrobial agent, an antiplatelet agent, an antimitotic agent, a microtubule inhibitor, an antisecretory agent, an antimetabolite, a chemotherapeutic agent, an immunosuppressive agent, a growth factor, an anti-growth factor antibody, a growth factor antagonist, a dopamine agonist, a radiotherapeutic agent, a heavy metal functioning as a radiopaque agent, a biologic agent, a angiotensin converting enzyme (ACE) inhibitor, a free radical scavenger, an iron chelator; an antioxidant, a sex hormone, an antipolymerase, an antiviral, a photodynamic therapy agent, an antibody, a prodrug, a cell migration inhibiting agent, and a gene therapy agents. 
   
   
       13 . The prosthetic valve of  claim 1 , wherein the bioactive agent comprises one or more endothelium progenitor cell attracting, binding and/or differentiating agents. 
   
   
       14 . The prosthetic valve of  claim 13 , wherein the one or more endothelium progenitor cell attracting, binding and/or differentiating agents comprises one or more of a chemoattractive agent, a polyclonal antibody, and a monoclonal antibody. 
   
   
       15 . The prosthetic valve of  claim 1 , wherein the leaflet comprises a bioremodellable material and the bioactive agent is adapted to prevent cellular deposition, cellular ingrowth, or cellular proliferation. 
   
   
       16 . The prosthetic valve of  claim 1 , wherein the leaflet comprises a bioremodellable material and the bioactive agent comprises one or more endothelium progenitor cell attracting, binding and/or differentiating agents. 
   
   
       17 . The prosthetic valve of  claim 16 , wherein the one or more endothelium progenitor cell attracting, binding and/or differentiating agents comprises one or more of a chemoattractive agent, a polyclonal antibody, and a monoclonal antibody. 
   
   
       18 . A prosthetic valve for selectively permitting fluid flow through a body vessel, said prosthetic valve comprising:
 a support frame;   a first leaflet attached to the support frame and having first and second free edges, the second free edge at least partially defining a first opening for permitting a controlled amount of said fluid flow through said body vessel;   a second leaflet attached to the support frame and having third and fourth free edges, the fourth free edge at least partially defining a second opening for permitting a controlled amount of said fluid flow through said body vessel;   the first and third free edges cooperatively defining a valve orifice adapted to open to permit said fluid flow through said body vessel in a first direction and close to substantially prevent said fluid flow through said body vessel in a second, opposite direction;   a bioactive agent associated with at least one of the second and fourth free edges;   wherein at least one of the first and third free edges is free of the bioactive agent.   
   
   
       19 . The prosthetic valve of  claim 18 , wherein the second free edge entirely defines the first opening. 
   
   
       20 . The prosthetic valve of  claim 18 , wherein the second free edge and a portion of the support frame define the first opening. 
   
   
       21 . A prosthetic valve for selectively permitting fluid flow through a body vessel, said prosthetic valve comprising:
 a support frame having first and second portions;   a first leaflet attached to the support frame and having first and second free edges, the second free edge cooperating with the first portion of the support frame to define a first opening for permitting a controlled amount of said fluid flow through said body vessel;   a second leaflet attached to the support frame and having third and fourth free edges, the fourth free edge cooperating with the second portion of the support frame to define a second opening for permitting a controlled amount of said fluid flow through said body vessel;   the first and third free edges cooperatively defining a valve orifice adapted to open to permit fluid flow through said body vessel in a first direction and close to substantially prevent fluid flow through said body vessel in a second, opposite direction;   a bioactive agent associated with at least one of the second and fourth free edges;   wherein at least one of the first and third free edges is free of the bioactive agent.