Endoluminal device for in vivo delivery of bioactive agents

Abstract

A method for making an implantable medical device for in vivo delivery of bioactive active agents to a situs in a body. The implantable structural element may be configured as an implantable prosthesis, such as an endoluminal stent, cardiac valve, osteal implant or the like, which serves a dual function of being prosthetic and a carrier for a bioactive agent. Alternatively, the implantable structural element may simply be an implantable article that serves the single function of acting as a time-release carrier for the bioactive agent.

What is claimed is: 
     
         1 . A method of making a drug-eluting implantable device comprising the steps of:
 a. Providing at least one of a plurality of tubular members, the at least one of a plurality of tubular members having a length, an outer surface, and a central lumen;   b. Forming a plurality of openings passing through the at least one of a plurality of tubular members, the plurality of openings communicating between the central lumen and the outer surface of the at least one of a plurality of tubular members;   c. Configuring the at least one of a plurality of tubular members to define undulating portions along the length of the at least one of a plurality of tubular members and forming a structure of the drug-eluting implantable device; and   d. Loading a bioactive agent through the plurality of openings and into the central lumen of the at least one of a plurality of tubular members.   
     
     
         2 . The method of  claim 1 , wherein the step of providing at least one of a plurality of tubular members further comprises the step of providing at least one of a plurality of elongate cylindrical members having a core of a sacrificial material and an outer layer of a device-forming metal. 
     
     
         3 . The method of  claim 2 , further comprising the step of removing the core of the at least one of a plurality of elongate cylindrical members, thereby forming the at least one of a plurality of tubular members having a central lumen. 
     
     
         4 . The method of  claim 3 , wherein the step of removing the core occurs after the step of forming a plurality of openings. 
     
     
         5 . The method of  claim 1 , wherein the step of forming one or more holes in the structural material comprises one of the methods of formation selected from the group consisting of microdrilling, laser cutting, etching, and EDM. 
     
     
         6 . The method of  claim 3 , wherein the step of removing the core further comprises the step of chemical etching. 
     
     
         7 . The method of  claim 1 , wherein the configuring step further comprises the step of winding the undulating form of the at least one of plurality of tubular members into a generally cylindrical shape defining a stent structure. 
     
     
         8 . The method of  claim 7 , further comprising the step of joining adjacent pairs of the undulating portions of the at least one of a plurality of tubular members. 
     
     
         9 . The method of  claim 8 , wherein the step of joining further comprises the step of welding adjacent pairs of the undulating portions of the at least one of a plurality of tubular members. 
     
     
         10 . An implantable drug-eluting device, consisting essentially of:
 a. At least one of a plurality of tubular members configured to define a plurality of undulating portions along a length of the at least one of a plurality of tubular members, the at least one of a plurality of tubular members being configured to define a structure of the implantable drug-eluting device;   b. A central lumen in the at least one of a plurality of tubular members; and   c. a plurality of openings passing through walls of the at least one of a plurality of tubular members and communicating with the central lumen; and   d. a bioactive agent disposed within the central lumen and capable of eluting through the plurality of openings.   
     
     
         11 . The implantable drug-eluting device of  claim 10 , wherein the at least one of a plurality of tubular members further comprises plural tubular members operably associated with one another in such a manner as to permit diametric expansion of the implantable drug-eluting device. 
     
     
         12 . The implantable drug-eluting device of  claim 11 , wherein the plural tubular elements are joined in a configuration selected from the group consisting of a grid configuration, a mesh configuration, and a braided configuration. 
     
     
         13 . The implantable drug-eluting device of  claim 10 , wherein the structure of the implantable drug eluting device is a stent. 
     
     
         14 . The implantable drug-eluting device of  claim 10 , wherein each of the plurality of openings are dimensioned to permit the bioactive agent to elute therefrom by diffusion, osmotic pressure or by cellular in-growth into the plurality of internal cavities. 
     
     
         15 . The implantable drug-eluting device of  claim 10 , wherein each of the plurality of tubular elements has an outer diameter between 60 and 400 μm and a wall thickness between 10 and 350 μm.