No-touch packaging configurations and application methods for hydrophilic intermittent catheters

Abstract

A packaging assembly for a hydrophilic catheter permits activation of a hydrophilic coating on the catheter and introduction of the catheter into a urethra in a sterile condition. A rupturable pouch containing a lubricant is enclosed in a chamber of the packaging assembly also occupied by the catheter. A portion of the packaging assembly in which the pouch is disposed is removable from the remaining portion of the packaging assembly following activation of the hydrophilic coating, such as by tearing along a line beginning at one or more tear notches, ripping along a perforation, cutting, or some combination thereof. The remaining portion of the packaging assembly may then be manipulated to introduce the catheter into a urethra, isolating at least an insertable portion of the catheter from human hands prior to contact with the urethra.

1 . A packaging assembly for sterile application of a hydrophilic catheter comprising: 
 a first sheet;    a second sheet heat sealed to the first sheet to form a chamber defined by the first and second sheets;    a hydrophilic catheter disposed in the chamber, said catheter having a distal end initially located adjacent a first end of the chamber and a proximal end initially located adjacent a second end of the chamber;    a pouch disposed within the chamber and located adjacent the first end of the chamber;    means for separating a first portion of the packaging assembly containing the pouch from a remaining portion of the packaging assembly.    
   
   
       2 . The packaging assembly of  claim 1 , wherein the means for separating the first portion of the packaging assembly containing the water pouch from the remaining portion of the packaging assembly includes at least one of: 
 (a) providing one or more tear notches in the first and second sheets spaced a greater distance from the first end of the chamber than a length of the pouch,    (b) providing a perforation line facilitating controlled ripping therealong, the perforation line extending along substantially an entire width of the packaging assembly and spaced a greater distance from the first end of the chamber than the length of the pouch;    (c) one or more cutting lines indicated on at least one of the first and second sheets through which a cutting device is used, said one or more cutting lines spaced a greater distance from the first end of the chamber than the length of the pouch; or    any combination of (a), (b), and (c).    
   
   
       3 . The packaging assembly of  claim 1 , wherein the distal end of the catheter initially overlies the pouch.  
   
   
       4 . The packaging assembly of  claim 3 , wherein the first sheet and second sheet may be peeled apart at one end thereof to create an opening for withdrawal of the proximal end of the catheter a distance sufficient to remove the distal end of the catheter from its initial location overlying the pouch without removing the distal end of the catheter from the packaging assembly.  
   
   
       5 . The packaging assembly of  claim 4 , wherein the catheter includes a hydrophilic coating extending over a lengthwise portion thereof, and the catheter being of such a length that none of an insertable length of the coated portion of the catheter need be outside the chamber upon said withdrawal of the proximal end of the catheter.  
   
   
       6 . The packaging assembly of  claim 1 , wherein the one or more cutting lines are indicated as printed indicia on an outer surface of at least one of the first and second sheets.  
   
   
       7 . A method for activating a hydrophilic coating of a catheter and for introducing the catheter into a urethra, comprising: 
 providing a packaging assembly having a first sheet and a second sheet, said first and second sheets being sealed to one another and defining a chamber enclosing a catheter having a hydrophilic coating therebetween;    providing a rupturable pouch within the chamber, said pouch containing a lubricant;    rupturing the pouch;    maneuvering the packaging assembly to distribute the lubricant across the hydrophilic coating of the catheter;    removing an end of the packaging assembly containing the pouch; and    manipulating the catheter within the packaging assembly to advance the catheter in a direction toward an opening created by said removal of the end of the packaging assembly containing the pouch while introducing the catheter into a urethra.    
   
   
       8 . The method of  claim 7 , wherein the packaging assembly is provided with at least one tear notch in the first and second sheets spaced a greater distance from a first end of the chamber than a length of the pouch, and said pouch being disposed adjacent the first end, and in removing the end of the packaging assembly containing the pouch, tearing along a line beginning at said at least one tear notch.  
   
   
       9 . The method of  claim 7 , wherein the packaging assembly is provided with a perforation line facilitating controlled ripping therealong, the perforation line extending along substantially an entire width of the packaging assembly and spaced a greater distance from a first end of the chamber than a length of the pouch, and said pouch being disposed adjacent the first end, and in removing the end of the packaging assembly containing the pouch, ripping along said perforation line.  
   
   
       10 . The method of  claim 7 , wherein the packaging assembly is provided with one or more cutting lines indicated on at least one of the first and second sheets, said one or more cutting lines spaced a greater distance from a first end of the chamber than a length of the pouch, and said pouch being disposed adjacent the first end, and in removing an end of the packaging assembly containing the pouch, cutting along said one or more cutting lines, and in removing the end of the packaging assembly containing the pouch, tearing along a line beginning at a terminus of said one or more cutting lines.  
   
   
       11 . The method of  claim 7 , wherein a distal end of the catheter initially overlies the pouch, and further comprising, prior to removing the end of the packaging assembly containing the pouch, partially separating the first and second sheets from one another to create an opening at an end of the packaging assembly adjacent a funnel of the catheter; and 
 withdrawing the funnel of the catheter through the opening a sufficient distance for the distal end of the catheter to no longer overlie the pouch.    
   
   
       12 . The method of  claim 11 , wherein in removing an end of the packaging assembly containing the pouch, cutting along a portion of the packaging assembly between the pouch and the distal end of the catheter.  
   
   
       13 . The method of  claim 7 , wherein in maneuvering the packaging assembly to distribute the lubricant across the hydrophilic coating of the catheter, the packaging assembly is tilted in a back and forth motion by repeatedly positioning a first end of the packaging assembly higher than a second end of the packaging assembly and then positioning the second end of the packaging assembly higher than the first end of the packaging assembly.