Medical needle assemblies

Abstract

A shielded, sterile, single-use unit dose needle assembly includes a unit dose needle with a hub and a packaging shield. The unit dose needle has a handle end and a prong end configured to hold a unit dose of a vaccine. The hub is fixedly attached to the handle end of the unit dose needle and includes a tapered mating surface. The packaging shield includes a tubular housing having an open end and a closed end with an internal opening extending therebetween. The open end of the packaging shield can be removably attached to the tapered mating surface of the hub to form an air-tight seal, with the unit dose needle contained within the internal opening.

What is claimed is:  
     
         1 . A shielded, sterile, single-use needle assembly for administering a unit dose of a vaccine comprising: 
 a unit dose needle having a handle end and a prong end configured to hold a unit dose of a vaccine;    a hub fixedly attached to the handle end of the unit dose needle and including a tapered mating surface; and    a packaging shield comprising a tubular housing having an open end and a closed end with an internal opening extending therebetween, the open end of the packaging shield being removably attached to the tapered mating surface of the hub to form an air-tight seal, with the unit dose needle contained within the internal opening.    
     
     
         2 . The needle assembly of  claim 1 , wherein the unit dose needle comprises a bifurcated needle, wherein the prong end includes two pointed prongs which are capable of penetrating or abrading the skin of a patient, and wherein the prongs are separated by a U-shaped channel capable of holding the unit dose of a vaccine.  
     
     
         3 . The needle assembly of  claim 1 , wherein the unit dose of a vaccine is a liquid.  
     
     
         4 . The needle assembly of  claim 1 , wherein the handle end is fixedly attached to the hub by an adhesive joint.  
     
     
         5 . The needle assembly of  claim 4 , wherein the adhesive joint comprises an epoxy adhesive.  
     
     
         6 . The needle assembly of  claim 14 , wherein the hub includes means for attachment to a medical device.  
     
     
         7 . The needle assembly of  claim 6 , wherein the hub includes an internal luer taper.  
     
     
         8 . The needle assembly of  claim 1 , wherein the hub includes a profile for accommodating a user's fingers.  
     
     
         9 . The needle assembly of  claim 1 , wherein the shield comprises one or more moldable plastics.  
     
     
         10 . The needle assembly of  claim 9 , wherein the plastics are one or more selected from the group consisting of polyethylenes, polypropylenes, polyamides, polyesters and fluorinated polyethylenes.  
     
     
         11 . The needle assembly of  claim 1 , further comprising a blister-type package comprised of a top web having a perimeter edge and a bottom web having a perimeter edge and comprising a pocket suitable for receiving the needle assembly therein, wherein the perimeter edge of the top web and the perimeter edge of the bottom web are sealed together along their respective lengths.  
     
     
         12 . The needle assembly of  claim 11 , wherein the bottom web has an embossing area capable of receiving printed images.  
     
     
         13 . The needle assembly of  claim 11 , wherein the top web comprises one or more of paper and a polymer film.  
     
     
         14 . The needle assembly of  claim 11 , wherein the bottom web comprises one or more of paper and a polymer film.  
     
     
         15 . A shielded, sterile, single-use bifurcated needle assembly for administering a vaccine comprising: 
 a hub including a tapered mating surface;    a bifurcated needle fixedly adhered to the hub and including two pointed prongs which are capable of penetrating or abrading the skin of a patient, and which are separated by a U-shaped channel which contains a unit dose of a vaccine; and    a packaging shield surrounding the bifurcated needle and removably attached to the tapered mating surface of the hub to form an air-tight seal between the hub and the packaging shield, thereby maintaining the bifurcated needle in a sterile environment within an interior of the packaging shield.    
     
     
         16 . The bifurcated needle assembly of  claim 15 , wherein the hub includes means for attachment to a medical device.  
     
     
         17 . The bifurcated needle assembly of  claim 15 , wherein the hub includes an internal luer taper.  
     
     
         18 . The bifurcated needle assembly of  claim 15 , wherein the hub includes a profile for accommodating a user's fingers.  
     
     
         19 . A method of packaging a single-use unit dose needle assembly comprising: 
 (a) providing a sheet of top web material, wherein the top web material comprises a plurality of rows, each row comprising a plurality of covers for a blister pack, each cover comprising a perimeter area;    (b) providing a sheet of bottom web material, wherein the bottom web material comprises a plurality of rows, each row comprising a plurality of bottoms for a blister pack, each bottom comprising a perimeter area and a pocket;    (c) providing a plurality of single-use unit dose needle assemblies comprising: 
 (i) a single-use unit dose needle including a prong end configured to hold a unit dose of a vaccine, and a handle end attached to a hub; and  
 (ii) a cylindrical needle shield having a closed end and an open end having a circumferential edge, the open end of the shield being capable of receiving the unit dose needle such that the circumferential edge securely engages a tapered surface of the hub;  
   (d) placing one of the single-use unit dose needle assemblies in (c) in each of the pockets in the bottom web material in (b); and    (e) sealing the perimeter areas in the top web material in (a) to the perimeter areas in the bottom web material in (b) to form a plurality of sealed single-use unit dose needle assembly packages.    
     
     
         20 . The method of  claim 19 , wherein the bottom web (b) has an embossing area capable of receiving printed images.  
     
     
         21 . The method of  claim 19 , wherein the top web material in (a) and the bottom web material in (b) comprises one or more of paper and a polymer film.  
     
     
         22 . The method of  claim 19 , further comprising cutting each row of sealed single-use unit dose needle assembly packages from the plurality of sealed single-use unit dose needle assembly packages.