Packaged ready-to-use product and method

Abstract

A vapor hydrated packaged catheter assembly and method of manufacturing and distributing same includes a gas impermeable package housing a catheter within a catheter-receiving cavity. The catheter assembly has a hydrophilic coating applied to at least a portion of the outer surface of a catheter tube or shaft which may be surrounded by a sleeve to provide a no-touch, sure grip feature. The catheter assembly is disposed within the catheter receiving cavity of the package together with a limited amount of a vapor donating liquid provided as a source of vapor to activate the hydrophilic coating. The amount of vapor donating liquid is less than the amount that would otherwise be sufficient to cause a spill hazard. It may be loose liquid as a desired percentage of the volume of a tube-receiving portion of the catheter receiving cavity of the package, or it may be contained in a liquid sequestering element. The activation of at least some of the hydrophilic coating occurs solely by reason of exposure of the outer surface of the catheter to a vapor produced by the vapor donating liquid. The distribution of the catheter following manufacture is delayed for a time sufficient to permit the vapor to complete hydration of the entire hydrophilic coating on the surface.

1 .- 9 . (canceled) 
     
     
         10 . A ready-to-use packaged catheter assembly, comprising:
 a gas impermeable package having a sealed cavity, the sealed cavity including a first compartment and a second compartment separated by a gas permeable, liquid impermeable wall;   a catheter tube having a hydrophilic surface disposed within the first compartment of the sealed cavity;   a vapor donating liquid disposed within the second compartment of the sealed cavity; and   an amount of vapor donated by said vapor donating liquid sufficient to produce a vapor hydration atmosphere within the sealed cavity to activate the hydrophilic surface of the catheter tube.   
     
     
         11 . The catheter assembly of  claim 10  wherein the hydrophilic surface comprises a hydrophilic coating. 
     
     
         12 . The catheter assembly of  claim 10  wherein the gas permeable, liquid impermeable wall comprises a gas permeable, liquid impermeable material. 
     
     
         13 . The catheter assembly of  claim 12  wherein the second compartment comprises a pouch defined by the gas permeable, liquid impermeable material. 
     
     
         14 . The catheter assembly of  claim 10  wherein the gas permeable, liquid impermeable wall comprises a gas permeable, liquid impermeable film comprising a polymeric material. 
     
     
         15 . The catheter assembly of  claim 14  wherein the gas permeable, liquid impermeable film defines a sleeve that extends over the catheter tube. 
     
     
         16 . The catheter assembly of  claim 14  wherein a fabric or foam liquid sequestering element is disposed in the second compartment. 
     
     
         17 . The catheter assembly of  claim 10  wherein the amount of vapor donated is sufficient to form a fully saturated vapor atmosphere within the package to ensure continuous hydration of the hydrophilic surface of the catheter tube through a product shelf life. 
     
     
         18 . A ready-to-use packaged product assembly, comprising:
 a gas impermeable package having a sealed cavity, the sealed cavity including a first compartment and a second compartment separated by a gas permeable, liquid impermeable barrier;   a product having a hydrophilic surface disposed within the first compartment of the sealed cavity;   a vapor donating liquid disposed within the second compartment of the sealed cavity; and   an amount of vapor donated by said vapor donating liquid sufficient to produce a vapor hydration atmosphere within the sealed cavity to activate the hydrophilic surface of the product.   
     
     
         19 . The catheter assembly of  claim 18  wherein the hydrophilic surface comprises a hydrophilic coating. 
     
     
         20 . The catheter assembly of  claim 18  wherein gas permeable, liquid impermeable wall comprises a gas permeable, liquid impermeable material. 
     
     
         21 . The catheter assembly of  claim 20  wherein the second compartment comprises a pouch defined by the gas permeable, liquid impermeable material. 
     
     
         22 . The catheter assembly of  claim 18  wherein the gas permeable, liquid impermeable wall comprises a gas permeable, liquid impermeable film comprising a polymeric material. 
     
     
         23 . The catheter assembly of  claim 22  wherein the gas permeable, liquid impermeable film defines a sleeve that extends over the product. 
     
     
         24 . The catheter assembly of  claim 22  wherein a fabric or foam liquid sequestering element is disposed in the second compartment. 
     
     
         25 . The catheter assembly of  claim 18  wherein the amount of vapor donated is sufficient to form a fully saturated vapor atmosphere within the package to ensure continuous hydration of the hydrophilic surface of the product through a product shelf life. 
     
     
         26 . A method of producing a packaged ready-to-use catheter, comprising:
 placing a hydrophilic coated catheter tube and a vapor donating liquid into a cavity of a package, wherein the hydrophilic coated catheter tube and the vapor donating liquid are separated by a gas permeable, liquid impermeable wall;   sealing the cavity of the package;   delaying distribution of the package to allow the formation of a vapor hydration atmosphere within the sealed cavity which actives the hydrophilic coated catheter tube.   
     
     
         27 . The method of  claim 26  wherein the package is formed of a material having a gas impermeability sufficient for a product shelf life in the range of between six months and five years. 
     
     
         28 . The method of  claim 26  wherein the distribution of the package is delayed for a determinable period of time of between 1 and 45 days to ensure complete vapor hydration of the hydrophilic coated catheter. 
     
     
         29 . The method of  claim 26  wherein the gas permeable, liquid impermeable wall comprises a gas permeable, liquid impermeable film comprising a polymeric material.