Pulsatile Peri-Corneal Drug Delivery Device

Abstract

The present invention is directed to a pulsatile ophthalmic peri-corneal drug delivery device. The device includes an annular body and a mechanism for releasing multiple separate and distinct doses of a therapeutic composition over an extended period of time.

We claim: 
     
         1 . An ophthalmic peri-corneal drug delivery device, comprising;
 an annular body sized and shaped to reside upon a conjunctiva of a human eye and extend substantially entirely about a cornea of the human eye when the annular body is disposed upon the human eye;   a therapeutic composition associated with the annular body; and   at least one opening for releasing the therapeutic composition wherein the therapeutic composition is released through the at least one opening topically to the eye as multiple separate doses through repeated release of one or more of a plurality of separate and distinct units.   
     
     
         2 . A device as in  claim 1  wherein the therapeutic composition is divided into the plurality of separate and distinct units within the annular body. 
     
     
         3 . A device as in  claim 1  wherein the device, the annular body or both include a contact surface that is shaped and sized to correspond to and contact the conjunctiva of the human eye upon application of the device to the eye. 
     
     
         4 . A device as in  claim 3  wherein the contact surface of the device including all portions that contact the conjunctiva has a surface area that is at least 77 mm 2  and is typically no greater than 220 mm 2 . 
     
     
         5 . A device as in  claim 1  wherein the device has a volume that is at least at least 14 mm 3  and is no greater than 100 mm 3 . 
     
     
         6 . An ophthalmic pericorneal drug delivery device, comprising;
 an annular body sized and shaped to reside upon a conjunctiva of a human eye and extend substantially entirely about a cornea of the human eye when the annular body is disposed upon the human eye;   a therapeutic composition associated with the annular body wherein the therapeutic composition is divided into a plurality of separate and distinct units;   a plurality of separate reservoirs, each of the plurality of reservoirs containing a separate and distinct unit of the plurality of units; and   a plurality of openings separately and respectively associated with the plurality of separate reservoirs for providing fluid communication to the plurality of reservoirs; and   a plurality of doors for separately and respectively covering the plurality of openings wherein each door of the plurality of doors is opened at a separate and distinct point in time to provide for separate release of the separate and distinct units over an extended period of time.   
     
     
         7 . A device as in  claim 6  wherein the plurality of doors are formed of an erodible material that is configured to erode is a manner that allows the distinct units to exit the annular body at separate and distinct periods of time. 
     
     
         8 . A device as in  claim 7  further comprising an electrical energy source associated with the annular body and an anode and a cathode associated with each of the plurality of openings wherein electrical energy sources provide energy to the anode and cathode to aid in eroding the erodible material of the doors. 
     
     
         9 . A device as in  claim 6  wherein the therapeutic composition includes a prostaglandin. 
     
     
         10 . A device as in  claim 6  wherein the device, the annular body or both include a contact surface that is shaped and sized to correspond to and contact the conjunctiva of the human eye upon application of the device to the eye. 
     
     
         11 . A device as in  claim 10  wherein the contact surface of the device including all portions that contact the conjunctiva has a surface area that is at least 77 mm 2  and is typically no greater than 220 mm 2 . 
     
     
         12 . A device as in  claim 11  wherein the device has a volume that is at least at least 14 mm 3  and is no greater than 100 mm 3 . 
     
     
         13 . An ophthalmic pericorneal drug delivery device, comprising;
 an annular body sized and shaped to reside upon a conjunctiva of a human eye and extend substantially entirely about a cornea of the human eye when the annular body is disposed upon the human eye;   a therapeutic composition associated with the annular body wherein the therapeutic composition is disposed as multiple separate distinct units in a single reservoir within the annular body;   an electromechanical device connected to the annular body; and   at least one opening for providing fluid communication between the single reservoir and an environment external of the device wherein the electromechanical device moves each unit to the at least one opening at a separate point in time over an extended time period.   
     
     
         14 . A device as in  claim 13  wherein each of the separate and distinct units comprises a polymeric shell defining at least one reservoir wherein the therapeutic composition is disposed in the at least one reservoir of the polymeric shell of each of the separate and distinct units. 
     
     
         15 . A device as in  claim 13  wherein the separate and distinct units comprise a body with a therapeutic composition coated thereon. 
     
     
         16 . A device as in  claim 13  wherein the separate and distinct units comprise a is polymeric matrix with therapeutic composition dispersed throughout the matrix. 
     
     
         17 . A device and in any of  claims 13  through  16  wherein the reservoir is annular and the separate and distinct units are distributed about the reservoir. 
     
     
         18 . A device and in  claim 13  wherein the therapeutic composition includes a prostaglandin. 
     
     
         19 . A device and in  claim 13  wherein the device, the annular body or both include a contact surface that is shaped and sized to correspond to and contact the conjunctiva of the human eye upon application of the device to the eye. 
     
     
         20 . A device as in  claim 19  wherein the contact surface of the device including all portions that contact the conjunctiva has a surface area that is at least 77 mm 2  and is typically no greater than 220 mm 2 . 
     
     
         21 . A device as in  claim 20  wherein the device has a volume that is at least at least 14 mm 3  and is no greater than 100 mm 3 . 
     
     
         22 . A method of treating an ophthalmic disease comprising:
 disposing a device as in  claim 1  on the conjunctiva of the eye.   
     
     
         23 . A method as in  claim 22  wherein the device is disposed and maintained upon the eye without the use of any mechanical fastening elements that extend into the eyeball. 
     
     
         24 . A method as in  claim 23  wherein the device is maintained upon the eye for an extended period of time that is at least 24 hours. 
     
     
         25 . A method of treating an ophthalmic disease comprising:
 disposing a device as in  claim 6  on the conjunctiva of the eye.   
     
     
         26 . A method of treating an ophthalmic disease comprising:
 disposing a device as in  claim 13  on the conjunctiva of the eye.