Abstract:
A kit for the administration of a drug, especially to the posterior segment of the eye, is disclosed. The kit may include a plastic tray having a specially designed plastic window that functions as a tamper-evident seal. The kit may also minimize potential damage to components of the kit that are specially designed for posterior segment ophthalmic administration.

Description:
[0001]     This application claims the priority of U.S. Provisional Application No. 60/519,133 filed Nov. 12, 2003. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention generally pertains to a kit for the administration of a drug, especially an ophthalmic drug. More particularly, but not by way of limitation, the present invention pertains to a kit for the administration of a drug to the posterior segment of the eye.  
       DESCRIPTION OF THE RELATED ART  
       [0003]     Several diseases and conditions of the posterior segment of the eye threaten vision. Age related macular degeneration (ARMD), choroidal neovascularization (CNV), retinopathies (e.g., diabetic retinopathy, vitreoretinopathy), retinitis (e.g., cytomegalovirus (CMV) retinitis), uveitis, macular edema, glaucoma, and neuropathies are several examples.  
         [0004]     ARMD is the leading cause of blindness in the elderly of developed countries. ARMD attacks the center of vision and blurs it, making reading, driving, and other detailed tasks difficult or impossible. About 200,000 new cases of ARMD occur each year in the United States alone. Current estimates reveal that approximately forty percent of the population over age 75, and approximately twenty percent of the population over age 60, suffer from some degree of macular degeneration. “Wet” ARMD is the type of ARMD that most often causes blindness. In wet ARMD, newly formed choroidal blood vessels (CNV) leak fluid and cause progressive damage to the retina.  
         [0005]     In the particular case of CNV in ARMD, three main methods of treatment are currently being developed, (a) photocoagulation, (b) photodynamic therapy, and (c) the use of angiogenesis inhibitors. Photocoagulation is the most common treatment modality for CNV. However, photocoagulation can be harmful to the retina and is impractical when the CNV is near the fovea. Furthermore, over time, photocoagulation often results in recurrent CNV. Photodynamic therapy is a relatively new technology. The long-term efficacy of photodynamic therapy to treat ARMD is still largely unknown. Oral or parenteral (non-ocular) administration of anti-angiogenic compounds is also being tested as a systemic treatment for ARMD. However, due to drug-specific metabolic restrictions, systemic administration usually provides sub-therapeutic drug levels to the eye. Therefore, to achieve effective intraocular drug concentrations, either an unacceptably high dose or repetitive conventional doses are required.  
         [0006]     Various needles and cannulae have been used to deliver drugs to the back of the eye, external to the globe. Examples of such needles and cannulae are disclosed in U.S. Pat. No. 6,413,245 and the references cited therein.  
         [0007]     Various implants have also been developed for delivery of anti-angiogenic (and other) compounds locally to the eye. Examples of such implants are disclosed in U.S. Pat. Nos. 5,824,072, U.S. Pat. No. 5,476,511, and U.S. Pat. No. 5,773,019.  
         [0008]     Kits for the administration of ophthalmic drugs have been reported in the literature. An example of such a kit is disclosed in International Publication No. WO 01/49226.  
         [0009]     However, a need exists in the field of ophthalmology for an improved kit for the administration of an ophthalmic drug, especially to the posterior segment of the eye. The improved kit should be safe for the patient, easy for the physician to use, capable of supporting the administration of a wide spectrum of drugs, and capable of supporting administration of drug in an outpatient setting.  
       SUMMARY OF THE INVENTION  
       [0010]     The present invention is a kit for the administration of a drug, especially to the posterior segment of the eye. In one aspect of the present invention, the kit may include a plastic tray having a specially designed plastic window that functions as a tamper-evident seal. In another aspect of the invention, the kit may minimize potential damage to components of the kit that are specially designed for posterior segment ophthalmic administration. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]     For a more complete understanding of the present invention, and for further objects and advantages thereof, reference is made to the following description taken in conjunction with the accompanying drawings in which:  
         [0012]      FIG. 1  is a perspective, schematic view of a kit for the administration of a drug according to a preferred embodiment of the present invention;  
         [0013]      FIG. 2  is a top, schematic view of an internal support structure of the kit of  FIG. 1 ;  
         [0014]      FIG. 3  is a top, schematic view of a plastic tray for holding the components of the kit of  FIG. 1 ;  
         [0015]      FIG. 4  is a front, schematic view of a vial holding the drug to be administered using the kit of  FIG. 1 ;  
         [0016]      FIG. 5  is a side, partially sectional, schematic view of a preferred embodiment of a cannula of the kit of  FIG. 1 ;  
         [0017]      FIG. 6  is a top, schematic view of primary packaging of the cannula of  FIG. 5 ;  
         [0018]      FIG. 7  is a top, schematic view of a syringe of the kit of  FIG. 1  and its primary packaging; and  
         [0019]      FIG. 8  is a top, schematic view of a needle and needle guard of the kit of  FIG. 1  and its primary packaging. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0020]     The preferred embodiments of the present invention and their advantages are best understood by referring to  FIGS. 1 through 8  of the drawings, like numerals being used for like and corresponding parts of the various drawings.  
         [0021]      FIGS. 1-3  schematically illustrate a kit  100  for the administration of a drug according to a preferred embodiment of the present invention. Kit  100  generally includes a setup structure  102 , a support structure  104  for disposing within setup structure  102 , and a plastic tray  106  for disposing within both support structure  104  and setup structure  102 . Kit  100  is preferred for administration of an ophthalmic drug, and kit  100  is most preferred for administration of a drug to the posterior segment of the eye. However, kit  100  may also be used for the administration of non-ophthalmic drugs.  
         [0022]     Referring to  FIGS. 3-8 , tray  106  includes a top surface  108 . Top surface  108  includes an area  112  for receiving a bottle or vial  114  of drug or pharmaceutical preparation  115  to be administered; an area  116  for receiving the primary packaging  118  of a cannula  50  for administering drug; and an area  122  for receiving the primary packaging  124  of a syringe  126  and the primary packaging  128  of needle  130  and needle guard or shield  132 , all of which are used for administering drug. Areas  112 ,  116 , and  122  are preferably recessed from top surface  108  and are preferably integrally molded into tray  106 .  
         [0023]     Bottle  114  is preferably a conventional glass vial  134  having a rubber stopper  136  retained by a sealing structure  138 . Drug  115  to be held in bottle  114  includes a pharmaceutically active agent. The pharmaceutically active agent may be any pharmaceutically active agent suitable for use in humans or animals, and is preferably any pharmaceutically active agent suitable for ophthalmic use. A preferred ophthalmic pharmaceutically active agent is an angiostatic steroid for the prevention or treatment of age related macular degeneration. Preferred angiostatic steroids include the angiostatic steroids disclosed in U.S. Pat. Nos. 5,679,666 and 5,770,592, which are incorporated herein in their entirety by this reference. Preferred ones of such angiostatic steroids are cortisenes including 4,9(11)-Pregnadien-17α,21-diol-3,20-dione and 4,9(11)-Pregnadien-17α,21-diol-3,20-dione-21-acetate.  
         [0024]     Primary packaging  118 ,  124 , and  128  are preferably conventional soft or hard plastic packaging having a removable, sterile paper cover. A preferred cannula  50  is shown in  FIG. 5  and is more fully disclosed in U.S. Pat. No. 6,413,245, which is incorporated herein in its entirety by this reference. Cannula  50  has a curved distal portion  52  and a straight proximal portion  54  separated by a bend  57 . Cannula  50  also has a hub  56 , a hollow bore  58 , blunt tip  62 , and an orifice  64 . As is more fully described in U.S. Pat. No. 6,413,245, the arc length A of distal portion  52 , the radius of curvature B of distal portion  52 , the angle C between a tangent  72  of distal portion  52  at bend  57  and proximal portion  54 , and the length D of proximal portion  54  are specially designed to facilitate drug delivery to the posterior segment of the eye. Syringe  126  is a conventional syringe such as the syringe available from Becton, Dickinson, and Company of Franklin Lakes, N.J. under part number 309628 W12811. Needle  130  is a conventional, straight needle, and needle guard  132  is a conventional needle guard. A preferred needle and needle guard is available from Becton, Dickinson, and Company under part number 305165.  
         [0025]     Tray  106  preferably also includes a clear plastic window or cover  140  that is adhered to top surface  108 . Window  140  preferably covers all of top surface  108 , including areas  112 ,  116 , and  122 . Window  140  preferably includes a perforation line  142  (shown in dashed lines) having a pre-cut section  144 . Window  140  is preferably made from polystyrene. Window  140  is preferably heat sealed to top surface  108  in a region  147  generally between perforation line  142  and the outer periphery  149  of top surface  108 .  
         [0026]     Referring to  FIG. 2 , support structure  104  is preferably made of a foldable, corrugated material of sufficient strength to protect tray  106  and its contents during shipping. Structure  104  has a top surface  146  with an opening  148  leading to an internal volume  150  designed to receive tray  106 . The outer periphery  149  of top surface  108  of tray  106  is supported by top surface  146 .  
         [0027]     Referring to  FIG. 1 , setup structure  102  is preferably made of foldable paperboard that is suitable for receiving high quality graphics via conventional printing methods. Structure  102  generally includes a body  152  having a top surface  154  with an opening  156  leading to an internal volume  158 , a cover  160  rotationally coupled to body  152  along an edge  162  of top surface  154 , and opposing ends  164   a  and  164   b . Ends  164   a  and  164   b  may be unfolded in the conventional manner of a carton to provide access to internal volume  158 . In addition, cover  160  may be removably secured to a front surface  161  of body  152  using a pressure sensitive tape or other conventional sealing material (not shown). Tray  106  is sized to fit within internal volume  150  of support structure  104 , and the resulting combination of tray  106  and structure  104  is sized to fit within internal volume  158  of setup structure  102 .  
         [0028]     Setup structures similar to structure  102  of the present invention having a body  152 , top surface  154 , an internal volume  158 , cover  160 , and opposing ends  164   a  and  164   b , but without opening  156 , are conventional. Such conventional structures may have a perforation line in the cardboard material of top surface  154  that can be broken to provide access to internal volume  158 . In addition, such conventional structures may have a clear plastic window disposed in the cardboard material of top surface  154  and within the perforation line to provide visibility to internal volume  158 .  
         [0029]     Kit  100  may be used by a physician and his or her staff in the following preferred manner. Kit  100  is shipped to a user as shown in  FIG. 1 , with the exception that cover  160  is secured to front surface  161  of structure  102  via pressure sensitive tape. When kit  100  is ready for use, the seal created by the pressure sensitive tape is broken and cover  160  is lifted as shown in  FIG. 1 . Clear plastic window  140  of tray  106  allows the user to visualize all the components required for drug delivery. In addition, if upon opening cover  160  perforation line  142  is unbroken, the user knows that the contents of kit  100  have not been tampered with subsequent to manufacture and that the contents of kit  100  are safe to use. The use of a perforated, clear plastic window  140 , versus a conventional Tyvek™ cover, also immediately signifies to a user that tray  106  and the exteriors of bottle  114  and primary packaging  118 ,  124 , and  128  are not sterile.  
         [0030]     Next, the user&#39;s thumb is placed within pre-cut section  144 , and window  140  is opened and preferably removed by pulling toward cover  160 , breaking perforation line  142 . Alternatively, only the sections of perforation line  142  nearest front surface  161  and opposing ends  164   a  and  164   b  may be broken. Window  140  then remains attached to top surface  108  by section  142   a  of perforation line  142 . Bottle  114  and primary packaging  118 ,  124 , and  128  may then be removed from tray  106 . When appropriate, needle  130  and needle guard  132  are removed from primary packaging  128 , syringe  126  is removed from primary packaging  124 , and cannula  50  is removed from primary packaging  118 . Needle  130  and needle guard  132  are fluidly coupled to syringe  126  in the conventional manner. Sealing structure  138  is removed from bottle  114  to expose rubber stopper  136 , and needle guard  132  is removed from syringe  130 . Needle  130  is then inserted through stopper  136 , and the appropriate amount of drug  115  is drawn into syringe  126  in the conventional manner. Needle guard  132  is then replaced on needle  130 , and needle  130  is removed from syringe  126  and replaced with cannula  50  in the conventional manner. The plunger of syringe  126  is actuated to prime cannula  50  with drug  115  and to eliminate all air from cannula  50 . Cannula  50  is then ready to administer drug  115  to the posterior segment of the eye, as is more fully described in U.S. Pat. No. 6,413,245. By including syringe  126  and needle  130 , as well as cannula  50 , within kit  100 , the possibility that a user would inadvertently try to draw drug  115  from bottle  114  into syringe  126  using cannula  50  is greatly minimized. This in turn minimizes or eliminates the possibility that the geometry of cannula  50  described above, which is critical to efficacious drug delivery to the posterior segment of the eye, is inadvertently altered prior to drug administration due to the force necessary to insert distal portion  52  of cannula  50  through stopper  136  of bottle  114 .  
         [0031]     From the above, it may be appreciated that the present invention provides an improved kit for the administration of an ophthalmic drug, especially to the posterior segment of the eye. The improved kit is safe for the patient, easy for the physician to use, capable of supporting the administration of a wide spectrum of drugs, and capable of supporting administration of drug in an outpatient setting.  
         [0032]     It is believed that the operation and construction of the present invention will be apparent from the foregoing description. While the apparatus and methods shown or described above have been characterized as being preferred, various changes and modifications may be made therein without departing from the spirit and scope of the invention as defined in the following claims.