Syringe

Abstract

The invention provides a syringe for use in an ophthalmic injection. The syringe comprises a body, a stopper and a plunger. The body comprises an outlet at an outlet end and the stopper is arranged within the body such that a front surface of the stopper and the body define a variable volume chamber from which a fluid can be expelled though the outlet. The plunger comprises a plunger contact surface at a first end and a rod extends between the plunger contact surface and a rear portion. The plunger contact surface is arranged to contact the stopper but not couple thereto, such that the plunger can be used to force the stopper towards the outlet end of the body, reducing the volume of the variable volume chamber, but not to move the stopper away from the outlet end.

1 - 47 . (canceled) 
     
     
         48 . A packaged, small volume, terminally sterilized syringe comprising:
 a body;   a stopper;
 wherein the body comprises an outlet at an outlet end and the stopper is arranged within the body such that a front surface of the stopper and the body define a variable volume chamber from which a fluid can be expelled through the outlet; 
 wherein the stopper comprises at least a front circumferential rib and a rear circumferential rib which are separated in a direction along the longitudinal axis of the body by at least 3 mm to define a sterility zone having a length extending from the front circumferential rib to the rear circumferential rib; 
 wherein the syringe is dimensioned to have a nominal maximum fill volume between 0.25 ml and 0.75 ml; and 
 a sealed package, wherein the small volume, terminally sterilized syringe is enclosed within the sealed package. 
   
     
     
         49 . The syringe of  claim 48 , wherein the stopper further comprises one or more circumferential ribs arranged between the front circumferential rib and the rear circumferential rib. 
     
     
         50 . The syringe of  claim 49 , wherein the stopper comprises three circumferential ribs. 
     
     
         51 . The syringe of  claim 48 , wherein the stopper comprises a conical-shaped front section. 
     
     
         52 . The syringe of  claim 48 , wherein a rear surface of the stopper comprises a substantially central recess. 
     
     
         53 . The syringe of  claim 52 , wherein the central recess is substantially cylindrical in shape. 
     
     
         54 . The syringe of  claim 52 , wherein the central recess comprises an initial bore having a first diameter, the initial bore leading from the rear surface of the stopper into the stopper to an inner recess having a second diameter, wherein the second diameter is larger than the first diameter. 
     
     
         55 . The syringe of  claim 48 , wherein the stopper is substantially rotationally symmetric about the first axis. 
     
     
         56 . The syringe of  claim 48 , wherein the stopper is made from rubber, silicone, or other resiliently deformable material. 
     
     
         57 . The syringe of  claim 48 , wherein the front circumferential rib and the rear circumferential rib are separated in a direction along the first axis of by at least 3.5 mm. 
     
     
         58 . The syringe of  claim 48 , wherein the front circumferential rib and the rear circumferential rib are separated in a direction along the first axis of by at least 3.75 mm. 
     
     
         59 . The syringe of  claim 48 , further comprising a plunger. 
     
     
         60 . The syringe of  claim 59 , wherein the outlet is reversibly sealed with a sealing device. 
     
     
         61 . The syringe of  claim 59 , wherein the plunger comprises a plunger contact surface at a first end and a rod extending between the plunger contact surface and a rear portion, the plunger contact surface is arranged to contact the stopper but does not couple thereto, such that the plunger can be used to force the stopper towards the outlet end of the body, thereby reducing the volume of the variable volume chamber, but does not to move the stopper away from the outlet end. 
     
     
         62 . The syringe of  claim 61 , wherein the rod includes at least one rod shoulder and the syringe includes a backstop arranged at a rear portion of the body, the backstop including a backstop shoulder to cooperate with and contact the rod shoulder to prevent movement of the plunger away from the outlet end to a distance less than the length of the sterility zone, wherein when the plunger contact surface is in contact with the stopper the backstop shoulder and the rod shoulder are not in contact with one another. 
     
     
         63 . The syringe of  claim 48 , wherein the variable volume chamber has an internal diameter between about 3 mm and about 6 mm. 
     
     
         64 . The syringe of  claim 48 , wherein the variable volume chamber contains gas or a bubble. 
     
     
         65 . The syringe of  claim 48 , which is dimensioned to have a nominal maximum fill volume of between about 0.4 ml and about 0.6 ml. 
     
     
         66 . The syringe of  claim 65 , wherein the nominal maximum fill volume is about 0.5 ml. 
     
     
         67 . The syringe of  claim 48 , which has a body length between 45 mm and 50 mm and a fill volume between 0.1 ml and 0.3 ml. 
     
     
         68 . The syringe of  claim 48 , which has an internal diameter between about 4.5 mm and about 4.8 mm. 
     
     
         69 . The syringe of  claim 48 , which is substantially silicone free or wherein the body is made out of plastic or glass. 
     
     
         70 . The syringe of  claim 48 , which is pre-filled with a medicament comprising an active ingredient suitable for ophthalmic injection. 
     
     
         71 . The syringe of  claim 70 , wherein the medicament comprises a VEGF antagonist. 
     
     
         72 . The syringe of  claim 71 , wherein the VEGF antagonist is an anti-VEGF antibody. 
     
     
         73 . The syringe of  claim 71 , wherein the VEGF antagonist is bevacizumab. 
     
     
         74 . The syringe of  claim 71 , wherein the VEGF antagonist is ranibizumab. 
     
     
         75 . The syringe of  claim 74 , wherein ranibizumab is in a dosage volume of 0.05 or 0.03 ml of a 10 mg/ml injectable medicament solution. 
     
     
         76 . The syringe of  claim 71 , wherein the VEGF antagonist is aflibercept. 
     
     
         77 . The syringe of  claim 76 , wherein aflibercept is in a dosage volume of 0.05 ml of a 40 mg/ml injectable medicament solution.