Reservoir Device for Intraocular Drug Delivery

Abstract

A delivery device that allows for the sustained release of an agent, particularly useful for the sustained release of a therapeutic agent to limited access regions, such as the posterior chamber of the eye and inner ear. The delivery device is minimally invasive, refillable and may be easily fixed to the treatment area. The delivery device includes a hollow body with an inlet port at its proximal end for insertion of the agent, a reservoir for holding the agent and a delivery mechanism for the sustained delivery of the agent from the reservoir to the patient.

What is claimed is: 
     
         1 . A method of delivering at least a first therapeutic agent into an interior chamber of a patient's eye having an ocular disorder, comprising:
 inserting a distal portion of an implant through a sclera of the eye and into the interior chamber, the implant comprising:
 a refillable reservoir made of one or more biocompatible materials and adapted to contain the first therapeutic agent, the reservoir comprising a proximal portion and a distal portion, the distal portion comprising a non-permeable body having multiple apertures formed through the body, such that, when implanted, the first therapeutic agent flows or diffuses through the apertures into the eye, wherein the multiple apertures are adapted to achieve a desired rate of controlled, sustained delivery of the first therapeutic agent to the eye to treat the disorder; and 
 an inlet portion coupled to the proximal portion of the reservoir and in fluid communication with the reservoir, the inlet portion being injectable and capable of self-sealing upon retraction of a needle, the inlet portion adapted, when implanted, to remain external to and adjacent the sclera; 
 wherein at least the distal portion of the reservoir extends into the eye upon insertion; and 
   treating the disorder for an initial treatment period of time through the controlled, sustained delivery of the first therapeutic agent.   
     
     
         2 . The method of  claim 1 , further comprising introducing a needle through the inlet portion to aspirate the reservoir. 
     
     
         3 . The method of  claim 1 , wherein the patient's eye comprises a vitreous cavity, wherein the distal portion of the implant is inserted into the vitreous cavity, and wherein the agent flows or diffuses into vitreous in the cavity through the apertures. 
     
     
         4 . The method of  claim 1 , further comprising removing the implant from the eye after a desired dose of agent has been delivered, and closing a scleral incision. 
     
     
         5 . The method of  claim 4 , wherein the scleral incision requires few or no sutures to close the sclera upon removal. 
     
     
         6 . The method of  claim 1 , wherein the implant is sufficiently structurally rigid to facilitate insertion into the eye. 
     
     
         7 . The method of  claim 6 , wherein the rigidity is provided to the implant by at least one of stainless steel, titanium and nitinol. 
     
     
         8 . The method of  claim 1 , wherein each of the apertures is formed in the reservoir by laser, hot wire, drilling device or similar mechanism. 
     
     
         9 . The method of  claim 1 , wherein the inlet portion comprises a scleral hub. 
     
     
         10 . The method of  claim 9 , wherein the scleral hub is circular. 
     
     
         11 . The method of  claim 9 , wherein the scleral hub conforms to a curvature of the eye. 
     
     
         12 . The method of  claim 1 , further comprising, after the initial treatment period, injecting additional therapeutic agent into the reservoir through the inlet portion, to continue to treat the patient for an additional treatment period without removing the implant from the eye. 
     
     
         13 . The method of  claim 1 , wherein each of the apertures has a length corresponding to a thickness of a wall of the body of the reservoir. 
     
     
         14 . The method of  claim 12 , wherein the additional therapeutic agent comprises a second therapeutic agent different from the first therapeutic agent. 
     
     
         15 . The method of  claim 1 , wherein the multiple apertures are adapted to achieve the desired rate of controlled, sustained delivery by varying at least one of the number and size of the apertures. 
     
     
         16 . The method of  claim 1 , wherein the distal portion of the reservoir is non-permeable to the therapeutic agent. 
     
     
         17 . The method of  claim 16 , wherein the non-permeable portion comprises at least 90% of the surface area of the reservoir. 
     
     
         18 . The method of  claim 1 , wherein the distal portion of the implant is roughly cylindrical upon insertion into the eye. 
     
     
         19 . The method of  claim 1 , wherein the desired rate of controlled, sustained delivery of the agent is determined based on an individual need of the patient. 
     
     
         20 . The method of  claim 12 , wherein the injecting additional agent is performed if further dose of agent is required for treatment of the disorder. 
     
     
         21 . The method of  claim 1 , wherein the first therapeutic agent is injected into the reservoir after insertion of the reservoir into the eye. 
     
     
         22 . The method of  claim 1 , wherein a diameter of the reservoir is about 1 mm or less upon insertion. 
     
     
         23 . An ocular implant for delivering a first therapeutic agent to an interior of a patient's eye having an ocular disorder, comprising:
 a refillable reservoir made of one or more biocompatible materials and adapted to contain the first therapeutic agent, the reservoir comprising a proximal portion and a distal portion, the distal portion comprising a non-permeable body having multiple apertures formed through the body, such that, when implanted in the eye, the first therapeutic agent flows or diffuses through the apertures and external to the reservoir, the multiple apertures adapted to achieve a desired rate of controlled, sustained delivery of therapeutic agent to the interior of the eye to treat the disorder; and   an inlet portion coupled to the proximal portion of the reservoir and in fluid communication with the reservoir, the inlet portion being injectable and capable of self-sealing upon retraction of a needle, the inlet portion adapted to accept injection of the agent and, when implanted, to remain external to and adjacent the sclera.   
     
     
         24 . The implant of  claim 23 , wherein the reservoir is capable of being aspirated. 
     
     
         25 . The implant of  claim 23 , wherein the patient's eye comprises a vitreous cavity, wherein the distal portion of the implant is capable of being inserted into the vitreous cavity, and wherein the agent flows or diffuses into vitreous in the cavity through the apertures when the implant is implanted in the cavity. 
     
     
         26 . The implant of  claim 23 , wherein the implant is sufficiently structurally rigid to facilitate insertion into the eye. 
     
     
         27 . The implant of  claim 23 , wherein the rigidity is provided to the implant by at least one of stainless steel, titanium and nitinol. 
     
     
         28 . The implant of  claim 23 , wherein the inlet portion comprises a scleral hub. 
     
     
         29 . The implant of  claim 28 , wherein the scleral hub is circular. 
     
     
         30 . The implant of  claim 28 , wherein the scleral hub is adapted to conform to a curvature of the eye. 
     
     
         31 . The implant of  claim 23 , wherein the reservoir is capable of containing an additional therapeutic agent upon refilling that comprises the first therapeutic agent or a different therapeutic agent. 
     
     
         32 . The implant of  claim 23 , wherein each of the apertures is formed in the reservoir by laser, hot wire, drilling device or similar mechanism. 
     
     
         33 . The implant of  claim 23 , wherein the multiple apertures are adapted to achieve the desired rate of controlled, sustained delivery by varying at least one of the number and size of the apertures. 
     
     
         34 . The implant of  claim 23 , wherein the distal portion of the reservoir is non-permeable to the therapeutic agent. 
     
     
         35 . The implant of  claim 34 , wherein the non-permeable portion comprises at least 90% of the surface area of the reservoir. 
     
     
         36 . The implant of  claim 23 , wherein the reservoir is roughly cylindrical at least during insertion into the eye. 
     
     
         37 . The implant of  claim 23 , wherein the desired rate of controlled, sustained delivery of the agent is determined based on an individual need of the patient. 
     
     
         38 . The implant of  claim 23 , wherein a diameter of the reservoir is about 1 mm or less upon insertion. 
     
     
         39 . The implant of  claim 23 , wherein each of the apertures has a length corresponding to a thickness of a wall of the distal portion of the reservoir. 
     
     
         40 . A sustained release delivery device for delivering an agent to the interior of a patient's eye, comprising:
 a reservoir having a proximal end and a distal end;   an inlet port near the proximal end of the reservoir for injection of an agent into the reservoir, the inlet port fabricated of an injectable self-sealing material; and   a delivery mechanism for delivering the agent from the reservoir to the interior of a patient's eye at a desired rate, the delivery mechanism comprising a plurality of apertures located near the distal end of the device, wherein each of the apertures has a length corresponding to a thickness of a wall of the reservoir, wherein the size and number of the plurality of apertures controls the rate of delivery of the agent from the distal end of the device.