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 the 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 - 29 . (canceled) 
   
   
       30 . An expandable tissue supporting device, comprising:
 a stent;   holes in struts of the stent; and   a release system comprising the holes and a beneficial agent contained in the holes.   
   
   
       31 . The device of  claim 30 , where the holes are configured to deliver the beneficial agent so that release is uniform and prolonged over an extended period of time. 
   
   
       32 . The device of  claim 30 , wherein release rate of the beneficial agent is linear. 
   
   
       33 . The device of  claim 30 , wherein the beneficial agent is released from the holes in three bursts. 
   
   
       34 . The device of  claim 30 , wherein the beneficial agent is released from the holes in three waves. 
   
   
       35 . The device of  claim 30 , wherein a carrier polymer comprises a biodegradable material that is a beneficial agent containing carrier, the carrier polymer being a fixed matrix polymer. 
   
   
       36 . The device of  claim 30 , wherein identical layers of the beneficial agent together form a uniform, homogeneous distribution of the beneficial agent. 
   
   
       37 . The device of  claim 30 , wherein there are at least two layers of beneficial agent in at least one of the holes, each layer having individual chemical compositions and pharmacokinetic properties. 
   
   
       38 . The device of  claim 30 , wherein the holes have layers of beneficial agent in a first biodegradable carrier material alternated with second layers of biodegradable carrier material. 
   
   
       39 . The device of  claim 34 , wherein the carrier polymer is biodegradable. 
   
   
       40 . The device of  claim 39 , wherein the carrier polymer comprises polyanhydrides or polyorthoesters. 
   
   
       41 . The device of  claim 34 , wherein the carrier polymer further comprises hydrogel. 
   
   
       42 . The device of  claim 30 , comprising a solid layer of beneficial agent or hydrogel. 
   
   
       43 . The device of  claim 30 , comprising beneficial layers that comprise the beneficial agent and a polymer carrier. 
   
   
       44 . The device of  claim 30 , wherein the beneficial layers comprise excipients. 
   
   
       45 . The device of  claim 30 , wherein the exterior surface of the stent is coated with a layer that acts as a barrier layer and prevents the beneficial agent in the holes from being released. 
   
   
       46 . The device of  claim 38 , wherein at least one of the beneficial agent containing carrier layers erodes thereby releasing the beneficial agent. 
   
   
       47 . The device of  claim 46 , further comprising a barrier layer comprising a biodegradable material that degrades at a rate over time. 
   
   
       48 . The device of  claim 45 , wherein the layer covering the exterior of the stent comprises a bioerodible matrix that comprises a polymer. 
   
   
       49 . The device of  claim 30 , wherein different beneficial agents may be disposed indifferent holes, wherein agents in different openings have different erosion rates, or one agent may be solid while another agent may be porous. 
   
   
       50 . The device of  claim 45 , wherein the barrier layer is activated by a separate, systemically applied agent to change the porosity of the barrier layer or change the rate of degradation of the barrier layer. 
   
   
       51 . The device of  claim 30 , wherein different beneficial agents are provided in different holes. 
   
   
       52 . The device of  claim 30 , wherein the beneficial agent comprises a protein, a polysaccharide, or a gene/vector construct. 
   
   
       53 . The device of  claim 30 , wherein the beneficial agent comprises an anesthetic. 
   
   
       54 . The device of  claim 30 , wherein the beneficial agent comprises an antibiotic. 
   
   
       55 . The device of  claim 30 , wherein the beneficial agent comprises an anti-inflammatory agent. 
   
   
       56 . The device of  claim 30 , wherein the beneficial agent comprises antihypertensives. 
   
   
       57 . The device of  claim 30 , wherein the beneficial agent is used for chemotherapy. 
   
   
       58 . The device of  claim 30 , wherein the beneficial agent comprises paclitaxil. 
   
   
       59 . The device of  claim 30 , wherein the beneficial agent comprises hormones. 
   
   
       60 . The device of  claim 30 , wherein the beneficial agent comprises an immunosuppressant. 
   
   
       61 . The device of  claim 30 , wherein the stent is an expandable tissue supporting medical device that is an interluminal vascular graft that is implanted within a body lumen. 
   
   
       62 . The device of  claim 30 , wherein the stent comprises metal.