Intraocular implant delivery apparatus and methods of use thereof

Abstract

Apparatus and methods for introducing a solid or semi-solid intraocular drug-containing implant into the anterior chamber of an eye are described. The drug-containing implant can be a rod-shaped biodegradable implant that may provide for the extended release of the drug and may be effective for treating a medical condition of the eye. The apparatus is ergonomically designed in the shape or style of a pen with tactile surfaces for easy gripping, a needle-rotation knob to permit orientation of the needle bevel in relation to the eye, and a spring-actuated mechanism for consistent deployment of the implant.

1 . An apparatus for injecting an intraocular implant into the anterior chamber of a patient's eye, the apparatus comprising:
 (a) an elongate housing having a longitudinal axis and having a proximal end and a distal end;   (b) an ejector button extending through an opening in the housing and moveable from a first position to a second position in a direction normal to the longitudinal axis of the housing;   (c) a needle having a proximal end and a distal beveled end, the needle extending longitudinally from the distal end of the housing, the needle having a lumen extending through the length of the needle such that an intraocular implant can be received within and translated through the lumen of the needle, the needle rotatable in clockwise and counter-clockwise directions about its long axis; and   (d) an implant holder having a proximal and a distal end and a lumen capable of receiving and holding an intraocular implant prior to activation of the apparatus, the implant holder located inside the housing, the implant holder further being capable of movement, upon activation of the apparatus, from a first position to a second position within the housing along the longitudinal axis of the housing and in a direction toward the distal end of the apparatus, the lumen of the implant holder aligned with the lumen of the needle such that an implant can slidably translate from the lumen of the implant holder into the lumen of the needle upon activation of the device, the implant holder capped at its distal end with a cross-slit membrane,
 wherein depression of the ejector button results in activation of the apparatus and ejection of the implant from the apparatus. 
   
     
     
         2 . The apparatus of  claim 1 , further comprising an intraocular implant, the implant located entirely within the implant holder, wherein the intraocular implant is a solid, rod-shaped, biodegradable, intraocular implant comprising a biodegradable polymer matrix and a pharmaceutically active agent associated with the biodegradable polymer matrix, wherein the pharmaceutically active agent is effective for treating a medical condition of the eye, and wherein the implant is 150 μm to 300 μm in diameter or width, 0.50 mm to 2.5 mm in length, and 20 μg to 120 μg in total weight. 
     
     
         3 . The apparatus of  claim 2 , wherein the length of the needle extending from the distal end of the housing is 4 mm to 8 mm. 
     
     
         4 . The apparatus of  claim 1 , further comprising a push rod having a proximal and a distal end, wherein prior to activation of the apparatus the distal end of the push rod is disposed in the lumen of the implant holder at the proximal end of the implant holder, and wherein the push rod is slidably receivable within the lumen of the implant holder and the lumen of the needle, and wherein the push rod is moveable along the longitudinal axis of the housing. 
     
     
         5 . The apparatus of  claim 4 , further comprising a spring-driven assembly engageable with the push rod for forcing the push rod through the implant holder and the lumen of the needle following activation of the apparatus. 
     
     
         6 . The apparatus of  claim 1  further comprising a needle-rotation knob located at the proximal end of the housing, whereby manual rotation of said knob in a clockwise or counter-clockwise direction relative to the longitudinal axis of the housing results in a corresponding clockwise or counter-clockwise rotation of the needle. 
     
     
         7 . The apparatus of  claim 1  further comprising implant inspection windows located on the distal end of the housing, wherein said implant inspection windows are configured to permit visual observation of an implant inside the housing prior to activation of the apparatus. 
     
     
         8 . The apparatus of  claim 1 , further comprising an implant delivery feedback window located on the housing, wherein said feedback window is configured to allow observation of a visible signal that indicates activation of the apparatus. 
     
     
         9 . The apparatus of  claim 1 , wherein said needle is a 28 gauge needle with a wall that is 0.0015 inches to 0.00225 inches thick. 
     
     
         10 . The apparatus of  claim 2 , wherein the pharmaceutically active agent is a steroid, a non-steroidal anti-inflammatory agent, an alpha 2 adrenergic receptor agonist, a prostamide, or a protein. 
     
     
         11 . A method of introducing an intraocular implant into the anterior chamber of a patient's eye, the method comprising:
 (a) penetrating the cornea of a patient's eye with a distal beveled end of a needle extending along a longitudinal axis from a distal end of an elongate housing of an intraocular implant delivery apparatus, the needle rotatable in a clockwise direction and a counter-clockwise direction about the longitudinal axis;   (c) inserting the needle into the anterior chamber of the patient's eye;   (d) ejecting the intraocular implant from the apparatus using an ejector button extending through an opening in the elongate housing into the anterior chamber of the patient's eye; and   (e) removing the needle from the patient's eye.   
     
     
         12 . The method of  claim 11 , wherein the penetrating step comprises inserting the needle into the cornea with a bevel of the needle oriented 180° away from a corneal surface of the eye. 
     
     
         13 . The method of  claim 12 , wherein the needle is inserted into the anterior chamber by inserting the needle through the cornea at a point just anterior to the limbus. 
     
     
         14 . The method of  claim 11 , wherein needle is inserted into the anterior chamber to a depth of about 4 mm to about 7.5 mm, as measured from a tip of the needle to the corneal surface where the needle first penetrates the eye, and wherein the needle is pointed toward the inferior anterior chamber angle before ejecting the implant. 
     
     
         15 . The method of  claim 11 , wherein the patient has glaucoma or ocular hypertension. 
     
     
         16 . An apparatus for injecting an intraocular implant into the anterior chamber of a patient's eye, the apparatus comprising:
 (a) an elongate housing having a longitudinal axis, a distal end of the elongate housing comprising implant inspection windows configured to permit visual observation of an implant within the elongate housing prior to activation of the apparatus;   (b) a needle extending longitudinally from the distal end of the housing, the needle having a distal beveled end and a lumen extending through the length of the needle such that an intraocular implant can be received within and translated through the lumen of the needle toward the distal beveled end;   (c) an implant holder located inside the elongate housing and having a lumen capable of receiving and holding the intraocular implant prior to activation of the apparatus; and   (d) an ejector button extending through an opening in the elongate housing and moveable from a first position to a second position to activate the apparatus to deliver the intraocular implant through the lumen of the needle.   
     
     
         17 . The apparatus of  claim 16 , wherein the implant holder is made of a transparent material such that the intraocular implant can be visualized through the implant inspection windows and the implant holder prior to activation of the apparatus. 
     
     
         18 . The apparatus of  claim 16 , wherein the implant holder comprises implant inspection windows, wherein alignment of the implant inspection windows of the implant holder with the implant inspection windows of the elongate housing permits visual observation of the intraocular implant within the apparatus prior to activation of the apparatus. 
     
     
         19 . The apparatus of  claim 18 , wherein the implant inspection windows of the elongate housing comprises two windows on a nose cone of the elongate housing separated from one another by about 180 degrees, and wherein the implant inspection windows of the implant holder comprises two windows on a needle hub of the implant holder located inside the nose cone and separated from one another by about 180 degrees. 
     
     
         20 . The apparatus of  claim 16 , wherein at least one of the inspection windows of the elongate housing is a magnifying element that magnifies a view of the implant inside the implant holder.