Ocular therapeutic agent delivery devices and methods for making and using such devices

Abstract

Ocular implant devices ( 10, 20, 121 ) for the delivery of a therapeutic agent to an eye ( 101, 301 ) in a controlled and sustained manner. Dual mode and single mode drug delivery devices ( 10, 20, 121 ) are illustrated and described. Implants ( 10, 20 ) suitable for subconjunctival placement are described. Implants ( 121, 10, 20 ) suitable for intravitreal placement also are described. The invention also includes fabrication and implementation techniques associated with the unique ocular implant devices ( 10, 20, 121 ) that are presented herein.

1 - 52 . (canceled) 
     
     
         53 . An ocular implant prepared by a process comprising the steps:
 (i) providing a microcentrifuge tube;   (ii) introducing a silicone fluid comprising silicone into the microcentrifuge tube;   (iii) placing a hollow cylinder within the microcentrifuge tube such that a portion of the hollow cylinder is submerged in the silicone fluid;   (iv) centrifuging the microcentrifuge tube to degas the silicone fluid;   (v) curing the silicone fluid;   (vi) introducing a pellet comprising a therapeutic agent into the hollow cylinder;   (vii) pouring additional silicone fluid the cylinder to completely immerse the pellet;   (viii) centrifuging the microcentrifuge tube to degas the additional silicone fluid;   (ix) centering the pellet to give a controlled radial thickness of degassed silicone fluid around the pellet;   (x) curing the additional silicone fluid to form a silicone encapsulated pellet; and   (xi) removing the silicone encapsulated pellet from the cylinder.   
     
     
         54 . The ocular implant of  claim 53 , wherein there is a delay before the curing step (x) to load the therapeutic agent into the additional silicone fluid. 
     
     
         55 . The ocular implant of  claim 54 , wherein the delay before the curing step (x) comprises maintaining the implant between about 20° C. to about 30° C. for about 18 hours to about 30 hours. 
     
     
         56 . The ocular implant of  claim 55 , wherein the delay before the curing step (x) comprises maintaining the implant between about 20° C. to about 30° C. for about 24 hours. 
     
     
         57 . The ocular implant of  claim 53 , wherein a further therapeutic agent is dispersed in the additional silicone fluid of step (vii). 
     
     
         58 . The ocular implant of  claim 57 , wherein a further therapeutic agent dispersed in the additional silicone fluid of step (vii) is different than the therapeutic agent in the pellet. 
     
     
         59 . The ocular implant of  claim 53 , wherein there is an initial higher release rate of therapeutic agent. 
     
     
         60 . A ocular implant prepared by a process comprising the steps:
 (i) providing a one-piece mold comprising at least one impression including lateral and depth dimensions sufficient to receive a pellet comprising a therapeutic agent and an upright rigid post fixed at a side of the impression;   (ii) introducing a silicone fluid comprising silicone into the mold;   (iii) submerging a pellet comprising a therapeutic agent in the silicone fluid;   (iv) centering the pellet to give a controlled radial thickness of silicone fluid around the pellet;   (v) centrifuging the mold to degas the silicone fluid;   (vi) pushing a polyester mesh down the rigid post to submerge the mesh in the silicone fluid;   (vii) curing the silicone fluid to form a silicone encapsulated pellet; and   (viii) removing the silicone encapsulated pellet from the mold.   
     
     
         61 . The ocular implant of  claim 60 , wherein there is a delay before the curing step (vii) to load the therapeutic agent into the silicone fluid. 
     
     
         62 . The ocular implant of  claim 61 , wherein the delay before the curing step (vii) comprises maintaining the implant between about 20° C. to about 30° C. for at about 18 to about 30 hours. 
     
     
         63 . The ocular implant of  claim 62 , wherein the delay before the curing step (vii) comprises maintaining the implant between about 20° C. to about 30° C. for at about 24 hours. 
     
     
         64 . The ocular implant of  claim 60 , wherein a further therapeutic agent is dispersed in the silicone fluid of step (ii). 
     
     
         65 . The ocular implant of  claim 64 , wherein a further therapeutic agent dispersed in the silicone fluid of step (ii) is different than the therapeutic agent in the pellet. 
     
     
         66 . The ocular implant of  claim 60 , wherein there is an initial higher release rate of therapeutic agent. 
     
     
         67 . The ocular implant of  claim 60 , wherein the mold comprises a suture platform. 
     
     
         68 . The ocular implant of  claim 67 , wherein the polyester mesh is embedded in the suture platform. 
     
     
         69 . The ocular implant of  claim 60 , wherein one component of the mold is polytetrafluoroethylene.