Drug delivery device

Abstract

A novel device and method for intradermal delivery of an active agent is provided. The device comprises a housing which contains a reservoir chamber. A flexible reservoir containing the active agent is placed in the chamber. Upon pressure on an actuator the active agents is delivered via a hollow needle to the skin.

What is claimed is: 
     
         1 . A device for administering to an animal a fluid drug comprising:
 a housing having a housing open upper end and a housing bottom base defining an interior chamber;   the housing bottom base having an aperture therein;   the interior chamber adapted to slideably receive therein a reservoir chamber in an initial reservoir chamber position at a first predetermined distance from the interior surface of the base of the housing, the reservoir chamber being confined to travel along a reservoir chamber travel path relative the housing;   the reservoir chamber defined by a reservoir chamber bottom base and surrounding reservoir chamber wall extending from the reservoir bottom base so as provide a reservoir open top;   the reservoir bottom base including a single hollow needle having a lower end and an upper non-skin contacting end wherein the single hollow needle is mounted in and transverses the reservoir bottom base such that the upper non-skin contacting end is disposed within the interior of the reservoir chamber and just below the reservoir and the lower skin-contacting end can extend beyond the aperture to a second position at a predetermined distance defined by the reservoir chamber travel path of the reservoir chamber bottom base to the housing base relative the housing;   a flexible filled reservoir body containing therein the fluid drug being located in the reservoir chamber near the reservoir open top and separated from the upper end of the single hollow needle in the first predetermined reservoir chamber position; and   an actuator having a plunger operably coupled thereto and terminating in a stopper, the stopper having formed therein a frusto-concical depression;   the frusto-concical depression having a depth corresponding to the length of the upper non-skin contacting end of the single hollow needle disposed within the interior of the reservoir chamber;   the plunger adapted to be in slidable communication within the reservoir chamber via the reservoir open top such that, in use, the stopper can communicate with the flexible filled reservoir body with a portion of the flexible filled reservoir body being received in the frusto-conical depression when in the second predetermined reservoir chamber position, wherein a force being applied to the actuator causes the lower end of the single hollow needle to enter the skin to the second position and further force causes the upper non-skin contacting end of the single hollow needle to pierce the reservoir body and puts the upper non-skin contacting end of the single hollow needle into fluid communication with the contents of the flexible filled reservoir body such that continuous force being applied to the actuator causes the stopper to compress the flexible filled reservoir body and expel the fluid drug through the single hollow needle and wherein the upper non-skin contacting end of the single hollow needle is located within a portion of the flexible filled reservoir body received in the frusto-concical depression once substantially all of the fluid drug is expelled.   
     
     
         2 . The device as defined in  claim 1 , wherein abutment of the housing bottom base with the reservoir chamber bottom base in the second predetermined reservoir chamber position acts to provide a predetermined length of travel of the single hollow needle through the aperture. 
     
     
         3 . The device as defined in  claim 1 , wherein the biasing means is located within the inner chamber between the housing bottom base and the reservoir bottom base so as to bias the reservoir chamber in the initial reservoir chamber position. 
     
     
         4 . The device as defined in  claim 1 , wherein the length of travel of the single hollow needle in the second predetermined reservoir chamber position is from about 0.5 mm to about 10 mm extending through the aperture. 
     
     
         5 . The device as defined in  claim 1 , wherein the length of travel of the single hollow needle in the second predetermined reservoir chamber position is from about 1.5 mm to about 8 mm extending through the aperture. 
     
     
         6 . The device as defined in  claim 1 , wherein the length of travel of the single hollow needle in the second predetermined reservoir chamber position is from about 3 mm to about 8 mm extending through the aperture. 
     
     
         7 . The device as defined in  claim 3 , wherein the biasing means is a spring. 
     
     
         8 . A process for producing a flexible fluid filled reservoir body comprising:
 aligning and contacting a first surface of a first plastics material sheet with a second surface of second plastics material sheet;   applying a first mold half to the exterior side of the first plastics material sheet and a second mold half to the exterior of the second plastics material sheet, at least one of the first mold half and the second mold half having a depression formed therein with an open vertical path extending outwardly of the first mold half and the second mold half;   sandwiching the first plastics material sheet and the second plastics material sheet between the first mold half and the second mold half;   applying a vacuum to the first mold half and the second mold half so as to form a bubble into the depression between the first surface and the second surface and produce a fluid filling path;   sealing the first surface to the second surface about the perimeter of the bubble and the fluid filling path;   filling a fluid into the bubble through the fluid filling path;   sealing the fluid filling path; and   trimming about the sealed perimeter of the bubble and the fluid filling path.   
     
     
         9 . The process as defined in  claim 8 , wherein the first surface and the second surface are provided by folding a single sheet of a plastics material in half. 
     
     
         10 . The process for producing a flexible fluid filled reservoir body as defined in  claim 8 , wherein the first plastics material sheet and the second plastics material sheet are provided as a thermoplastics material and the first plastics material sheet and the second plastics material sheet are heated prior to sandwiching. 
     
     
         11 . The process for producing a flexible fluid filled reservoir body as defined in  claim 8 , wherein at least one of the first mold half and the second mold half are heatable for softening and/or bonding the first surface to the second surface. 
     
     
         12 . The process for producing a flexible fluid filled reservoir body as defined in  claim 8 , wherein the first plastics material sheet and the second plastics material sheet are provided in a colour and said colour corresponds to a particular fluid. 
     
     
         13 . The process for producing a flexible fluid filled reservoir body as defined in  claim 8 , wherein the fluid is provided a liquid drug. 
     
     
         14 . The device for administering to an animal a fluid drug as defined in  claim 1 , wherein the flexible fluid filled reservoir body is produced by:
 aligning and contacting a first surface of a first plastics material sheet with a second surface of second plastics material sheet;   applying a first mold half to the exterior side of the first plastics material sheet and a second mold half to the exterior of the second plastics material sheet, at least one of the first mold half and the second mold half having a depression formed therein with an open vertical path extending outwardly of the first mold half and the second mold half;   sandwiching the first plastics material sheet and the second plastics material sheet between the first mold half and the second mold half;   applying a vacuum to the first mold half and the second mold half so as to form a bubble into the depression between the first surface and the second surface and produce a fluid-filling path, the bubble correspondingly sized to fit within the reservoir chamber;   sealing the first surface to the second surface about the perimeter of the bubble and the fluid filling path;   filling the fluid drug into the bubble through the fluid filling path;   sealing the fluid filling path; and   trimming about the sealed perimeter of the bubble and the fluid-filling path so as to produce the flexible fluid filled reservoir body.