Packaged ready-to-use product

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.

The invention claimed is: 
     
       1. A catheter assembly, comprising:
 a package containing:
 a catheter having a hydrophilic outer surface; and 
 a pouch having an amount of vapor donating liquid therein, the pouch being comprised of a vapor permeable, liquid impermeable material. 
   
     
     
       2. The catheter assembly of  claim 1  wherein the hydrophilic outer surface comprises a hydrophilic coating. 
     
     
       3. The catheter assembly of  claim 1  wherein the package is comprised of a liquid and gas impermeable material. 
     
     
       4. The catheter assembly of  claim 1  wherein vapor donating liquid comprises water. 
     
     
       5. The catheter assembly of  claim 4  wherein water produces sufficient water vapor to form 100% relative humidity atmosphere within the package. 
     
     
       6. The catheter assembly of  claim 4  wherein the amount of water is 20 ml. 
     
     
       7. The catheter assembly of  claim 1  wherein the vapor donating liquid donates a vapor and the vapor activates at least a portion of the hydrophilic outer surface. 
     
     
       8. The catheter assembly of  claim 7  wherein the vapor donating liquid comprises water and the vapor comprises water vapor. 
     
     
       9. The catheter assembly of  claim 1  wherein the pouch contains sufficient vapor donating liquid to form a fully saturated vapor atmosphere within the package to ensure continuous hydration of the hydrophilic outer surface of the catheter through the product shelf life. 
     
     
       10. A packaged ready-to-use product, comprising:
 a package containing:
 a product having a hydrophilic surface; and 
 a pouch having an amount of vapor donating liquid therein, the pouch being comprised of a vapor permeable, liquid impermeable material. 
   
     
     
       11. The packaged product of  claim 10  wherein the hydrophilic surface comprises a hydrophilic coating. 
     
     
       12. The packaged product of  claim 10  wherein the package is comprised of a liquid and gas impermeable material. 
     
     
       13. The packaged product of  claim 10  wherein vapor donating liquid comprises water. 
     
     
       14. The packaged product of  claim 13  wherein water produces sufficient water vapor to form 100% relative humidity atmosphere within the package. 
     
     
       15. The packaged product of  claim 13  wherein the amount of water is 20 ml. 
     
     
       16. The packaged product of  claim 10  wherein the vapor donating liquid donates a vapor and the vapor activates at least a portion of the hydrophilic surface. 
     
     
       17. The packaged product of  claim 16  wherein the vapor donating liquid comprises water and the vapor comprises water vapor. 
     
     
       18. The packaged product of  claim 10  wherein the pouch contains sufficient vapor donating liquid to form a fully saturated vapor atmosphere within the package to ensure continuous hydration of the hydrophilic surface of the product through the product shelf life. 
     
     
       19. The packaged product of  claim 10  wherein the product comprises a medical product. 
     
     
       20. A ready-to-use hydrophilic urinary catheter assembly, comprising:
 a gas impermeable package containing:
 an amount of liquid; 
 a hydrophilic coated urinary catheter including a catheter tube having a proximal insertion end and a distal end; 
 a port having an axial passage for advancement of the catheter therethrough; and 
 a collapsible sleeve being attached to the port.  
   
     
     
       21. The catheter assembly of claim 20 wherein the port comprises an annular guide housing.  
     
     
       22. The catheter assembly of claim 20 wherein the port includes a proximal end and a distal end and the proximal end of the port is wider than the distal end of the port.  
     
     
       23. The catheter assembly of claim 20 further including a connector located at the distal end of the catheter tube.  
     
     
       24. The catheter assembly of claim 23 wherein the collapsible sleeve is attached to the connector.  
     
     
       25. The catheter assembly of claim 23 wherein the connector comprises a funnel.  
     
     
       26. The catheter assembly of claim 20 wherein the collapsible sleeve surrounds the catheter tube to permit gripping of the catheter tube through the sleeve.  
     
     
       27. The catheter assembly of claim 20 wherein the collapsible sleeve is formed of a material selected from polyethylene, plasticized PVC, polypropylene, polyurethane, and polyethylene oxide block copolymer.  
     
     
       28. The catheter assembly of claim 20 wherein the proximal insertion end of the catheter tube is located in the axial passage of the port.  
     
     
       29. A ready-to-use hydrophilic urinary catheter and package, comprising:
 a gas impermeable package having a top edge, a bottom edge and a sealed cavity, wherein the sealed cavity is defined in part by a transverse seal spaced from the top edge of the package;   an amount of liquid located in the sealed cavity;   a hydrophilic coated urinary catheter located in the sealed cavity, the hydrophilic coated catheter including a catheter tube having a proximal insertion end and a distal end wherein a connector is associated with the distal end of the catheter tube; and   a port having an axial passage for sliding advancement of the hydrophilic coated catheter therethrough, a collapsible sleeve having a proximal end portion attached to the port and a distal end attached to the connector wherein the collapsible sleeve surrounds the catheter tube.    
     
     
       30. The catheter and package of claim 29 wherein the port comprises an annular guide housing.  
     
     
       31. The catheter and package of claim 29 wherein the port includes a proximal end and a distal end and the proximal end of the port is wider than the distal end of the port.  
     
     
       32. The catheter and package of claim 29 wherein the transverse seal has a generally arcuate shape.  
     
     
       33. The catheter and package of claim 29 wherein the transverse seal comprises opposed upwardly extending seal portions that join at an apex.  
     
     
       34. The catheter and package of claim 29 wherein the transverse seal is generally chevron shaped.  
     
     
       35. The catheter and package of claim 29 wherein the connector comprises a funnel.  
     
     
       36. A ready-to-use hydrophilic urinary catheter assembly, comprising:
 a sealed gas impermeable package containing:
 an amount of liquid; 
 a hydrophilic coated urinary catheter including a catheter tube having a proximal insertion end and a distal end, a connector being located at the distal end of the catheter tube; 
 a port having an axial passage for advancement of the catheter therethrough and into the urethra; and 
 a sleeve surrounding the catheter tube and being attached to the connector and to the port.  
   
     
     
       37. The catheter assembly of claim 36 wherein the port comprises an annular guide housing.  
     
     
       38. The catheter assembly of claim 36 wherein the port includes a proximal end and a distal end and the proximal end of the port is wider than the distal end of the port.  
     
     
       39. The catheter assembly of claim 36 wherein the connector comprises a funnel.