Implantable intraocular drug delivery apparatus, system and method

Abstract

The present invention relates to an apparatus, system and method for, and for providing, intraocular delivery of an active agent. The apparatus, system and method may include an implantable scaffold and an active agent associated with the implantable scaffold. The implantable scaffold and the active agent may be configured to be completely contained within the eye upon implantation. The implantable scaffold may be a mechanical scaffold, or the implantable scaffold may be a chemical scaffold.

1 .- 29 . (canceled) 
     
     
         30 . An intraocular active agent delivery system, comprising:
 an implantable mechanical scaffold that includes an interior reservoir and is formed from a material that is suitable for intraocular implantation and takes the shape of a cylinder;   an external reservoir that is separate from the implantable mechanical scaffold, configured to be positioned outside of an eye when the implantable mechanical scaffold is implanted in the eye, and is fluidly connected to the interior reservoir via a tube, and includes an injection port;   an active agent at least physically associated with said implantable mechanical scaffold, wherein said implantable mechanical scaffold and said active agent are configured to be completely contained within the eye upon implantation; and   wherein the internal reservoir is configured to be refilled with the active agent via the injection port of the external reservoir after the implantation of the implantable mechanical scaffold in the eye.   
     
     
         31 . The system of  claim 30 , wherein the interior reservoir contains a least a portion of the active agent. 
     
     
         32 . The system of  claim 30 , wherein the reservoir releases at least a portion of the active agent in response to a condition within the eye. 
     
     
         33 . The system of  claim 30 , wherein the implantable mechanical scaffold comprises a coating comprising at least a portion of the active agent. 
     
     
         34 . The system of  claim 33 , wherein at least some of the active agent is configured to be released from the coating over time. 
     
     
         35 . The system of  claim 30 , wherein the active agent is delivered over a period of at least 6 months. 
     
     
         36 . The system of  claim 30 , wherein the active agent is delivered over a period of at least 1 year. 
     
     
         37 . The system of  claim 30 , wherein the implantable scaffold comprises a chemical scaffold. 
     
     
         38 . The system of  claim 37 , wherein the chemical scaffold comprises a polymeric gel. 
     
     
         39 . The system of  claim 38 , wherein the polymeric gel comprises a polysaccharide. 
     
     
         40 . The system of  claim 38 , wherein the active agent is released from the polymeric gel upon degradation of the polymeric gel. 
     
     
         41 . The system of  claim 30 , wherein the active agent is connected to the chemical scaffold by covalent bonding. 
     
     
         42 . The system of  claim 30 , wherein the active agent is connected to the chemical scaffold by ionic coupling. 
     
     
         43 . The system of  claim 30 , wherein the active agent is covalently bonded to the chemical scaffold by an ester linkage; an amide linkage, or a combination thereof. 
     
     
         44 . The system of  claim 30 , wherein the active agent is ionically coupled to the chemical scaffold. 
     
     
         45 . The system of  claim 39 , wherein the polysaccharide has an average molecular weight of 700 kDa or greater. 
     
     
         46 . The system of  claim 39 , wherein the polysaccharide has an average molecular weight of 1000 kDa or greater. 
     
     
         47 . The system of  claim 39 , wherein at least two polysaccharides are cross-linked through carboxylic acid groups. 
     
     
         48 . The system of  claim 39 , wherein at least two polysaccharides are cross-linked through hydroxyl groups. 
     
     
         49 . An implantable scaffold suitable for intraocular delivery of at least one active agent, the implantable scaffold comprising:
 at least one mechanical vehicle that is formed from a material that is suitable for intraocular implantation and takes the shape of a cylinder; and   at least one physical association of said at least one active agent with said at least one vehicle, wherein said at least one physical association is suitable for intraocular delivery of said at least one active agent by said at least one vehicle upon the intraocular implantation of at least said at least one vehicle, said physical association, and said at least one active agent,   wherein said at least one vehicle is configured to be connected to an external reservoir, that is separate from the mechanical vehicle and is positioned outside of an eye after implantation of the mechanical vehicle in the eye, via a tube, for refillable delivery of said at least one active agent to the mechanical vehicle via an injection port of said external reservoir after implantation of said at least one vehicle in the eye.