Expandable medical device for delivery of beneficial agent

Abstract

An expandable medical device has a plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of said strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. Alternatively, the beneficial agent is loaded in a shape which is configured to achieve the desired agent delivery profile. A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

1 . An expandable medical device comprising: 
 a plurality of elongated struts, said plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, said plurality of struts each having a strut width in a circumferential direction and a strut thickness in a radial direction;    at least one opening in at least one of the plurality of struts; and    at least one beneficial agent provided in the at least one opening in a plurality of layers, wherein the at least one opening comprises a plurality of openings containing the beneficial agent and a plurality of openings extending through the struts and remaining open.    
     
     
         2 . An expandable medical device comprising: 
 a substantially cylindrical, expandable medical device formed of a plurality of struts;    a plurality of openings in the plurality of struts, the openings extending through the struts with the openings having a substantially constant cross section from a radially outermost surface of the strut to a radially innermost surface of the strut;    a beneficial agent provided in the plurality of openings; and    a barrier layer provided in the plurality of openings and configured to substantially prevent delivery of the beneficial agent to a first side of the medical device while allowing delivery of the beneficial agent to a second side of the medical device.    
     
     
         3 . The expandable medical device according to  claim 2 , wherein the barrier layer is positioned adjacent an inner surface of the substantially cylindrical medical device.  
     
     
         4 . The expandable medical device according to  claim 2 , wherein the barrier layer is coated on the device.  
     
     
         5 . The expandable medical device according to  claim 2 , wherein the barrier layer is loaded in the openings.  
     
     
         6 . The expandable medical device according to  claim 2 , wherein the expandable medical device is a stent.  
     
     
         7 . An expandable medical device comprising: 
 an expandable cylindrical device having a plurality of struts; 
 a plurality of through openings in the plurality of struts, each opening having a radial innermost end and a radial outermost end; and  
 a beneficial agent provided in the plurality of through openings in a plurality of degradable beneficial agent layers; and  
 a barrier layer provided at the radial innermost end of the plurality of through openings, the barrier layer degrading more slowly than the beneficial agent layers, and the barrier layer substantially preventing fluid passage there through.  
   
     
     
         8 . The expandable medical device according to  claim 7 , wherein the barrier layer is loaded in the plurality of through openings.  
     
     
         9 . The expandable medical device according to  claim 7 , wherein the beneficial agent is paclitaxel.  
     
     
         10 . The expandable medical device according to  claim 7 , wherein the beneficial agent is rapamycin.  
     
     
         11 . The expandable medical device according to  claim 7 , wherein the beneficial agent is a protein drug.  
     
     
         12 . The expandable medical device according to  claim 2 , wherein the beneficial agent is paclitaxel.  
     
     
         13 . The expandable medical device according to  claim 2 , wherein the beneficial agent is rapamycin, or an analogue or derivative thereof.  
     
     
         14 . The expandable medical device according to  claim 2 , wherein the beneficial agent is a protein drug.  
     
     
         15 . The expandable medical device according to  claim 2 , wherein the beneficial agent and barrier layers are arranged on top of one another in the radial direction.  
     
     
         16 . The expandable medical device according to  claim 7 , wherein the plurality of degradable beneficial agent layers are arranged on top of one another in the radial direction.  
     
     
         17 . The expandable medical device according to  claim 2 , wherein the beneficial agent and barrier layers are arranged on top of one another in the radial direction.  
     
     
         18 . The expandable medical device according to  claim 7 , wherein the plurality of degradable beneficial agent layers are arranged on top of one another in the radial direction.  
     
     
         19 . The expandable medical device according to  claim 2 , wherein the beneficial agent is an anti-thrombotic agent.  
     
     
         20 . The expandable medical device according to  claim 7 , wherein the beneficial agent is an anti-thrombotic agent.  
     
     
         21 . The expandable medical device according to  claim 2 , wherein the beneficial agent is an anti-inflammatory agent.  
     
     
         22 . The expandable medical device according to  claim 7 , wherein the beneficial agent is an anti-inflammatory agent.  
     
     
         23 . The expandable medical device according to  claim 2 , wherein the beneficial agent is an antimitotic agent.  
     
     
         24 . The expandable medical device according to  claim 7 , wherein the beneficial agent is an antimitotic agent.  
     
     
         25 . The expandable medical device according to  claim 2 , wherein the beneficial agent is an anti-platelet agent.  
     
     
         26 . The expandable medical device according to  claim 7 , wherein the beneficial agent is an anti-platelet agent.