Sterile packaging of medical devices with enhanced tamper evident, transportation, functional and disposal features

Abstract

A syringe assembly (or other medical device) includes a single syringe entirely enclosed and sealed within a shrink-wrap film package, with one of the syringe or package formed so as to facilitate removal of at least a portion of the shrink wrap package. A related method of packaging, using and disposing of a syringe includes enclosing and sealing a single syringe assembly within a shrink wrap package, the syringe assembly including a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel; removing a portion of the shrink wrap package enclosing the needle; using the syringe in a liquid injection or removal mode while leaving a remaining portion of the shrink wrap package on the syringe assembly; and disposing the used syringe assembly with the remaining portion of the shrink wrap package in place on the syringe. Because of the closely applied packaging film reduced volume and weight of secondary packaging and consequent, reduced sterilization, transportation, and disposal costs. Use of distinctive shrink-wrap color, structure or other characteristic prevents simple deceptive duplication. Applicability to other devices which require internal sterility, but do not require external sterility in use.

1 . A syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap film or package. 
   
   
       2 . The syringe package of  claim 1  wherein said syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel. 
   
   
       3 . The syringe package of  claim 1  wherein said shrink-wrap package is formed with at least one pull tab for removing at least a portion of said shrink-wrap package. 
   
   
       4 . The syringe package of  claim 1  wherein said shrink-wrap package or pull tab is formed of materials of distinctive, easily recognized color or structure. 
   
   
       5 . The syringe package of  claim 3  wherein said shrink-wrap package is formed with a pair of pull tabs at opposite ends of said package. 
   
   
       6 . The syringe package of  claim 2  wherein said shrink-wrap package is formed with at least one pull tab for removing at least a portion of said shrink-wrap package, said pull tab connected to a partial tear or weakened strip extending axially along the barrel of the syringe. 
   
   
       7 . The syringe package of  claim 3  wherein said pull tab is connected to a line of weakening extending annularly about the syringe at a distal end thereof, rearward of said needle. 
   
   
       8 . The syringe package of  claim 3  wherein said pull tab is connected to a line of weakening extending annularly about the syringe at a proximal end thereof, forward of said thumb press. 
   
   
       9 . The syringe package of  claim 2  wherein said syringe is also provided with a needle cap formed with a radially outwardly directed flange engaged by said shrink-wrap package. 
   
   
       10 . The syringe package of  claim 2  wherein said barrel is formed with a flange of a proximate end thereof, adjacent said thumb press. 
   
   
       11 . A syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap package, wherein said syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel, and wherein said shrink-wrap package is formed with at least one pull tab connected to an annular line of weakening located at a distal end of said syringe but rearward of said needle. 
   
   
       12 . A syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap package, wherein said syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel, at least one of said syringe and said shrink wrap package provided with means for facilitating removal of at least a portion of said shrink wrap package. 
   
   
       13 . A tamper-evident syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap package, wherein said syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel, at least one of said syringe and said shrink wrap package provided with means for facilitating removal and destruction of at least a portion of said shrink wrap package. 
   
   
       14 . A method of packaging, using and disposing of a syringe comprising:
 enclosing and sealing a single syringe assembly within a shrink wrap package, the syringe assembly including a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel;   removing a portion of the shrink wrap package enclosing the needle;   removing a portion of the shrink wrap package enclosing the end of the plunger   using the syringe in a liquid injection or removal mode while leaving a remaining portion of the shrink wrap package on the syringe assembly; and   disposing the used syringe assembly with the remaining portion of the shrink wrap package in place on the syringe.   
   
   
       15 . The method of  claim 14  including providing one of said syringe and said shrink wrap package with means for facilitating removal of at least a portion of said shrink wrap package. 
   
   
       16 . The method of  claim 15  wherein said means may annularly or axially oriented.