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.

Description:
REFERENCE TO RELATED APPLICATIONS  
       [0001]     This disclosure claims priority to, and is entitled to the benefit of the filing dates of, U.S. Provisional Application No. 60/515,606, filed Oct. 30, 2003, and 60/536,065, filed Jan. 13, 2004, for all subject matter commonly disclosed therein. 
     
    
     FIELD OF THE DISCLOSURE  
       [0002]     This disclosure relates generally to packaging of urinary catheters and, more specifically, to packaging facilitating exposure of a hydrophilic coating of an intermittent catheter to a lubricant while contained within the packaging as well as sterile application of the lubricated catheter.  
       BACKGROUND  
       [0003]     Current competitive hydrophilic intermittent urinary catheters are packaged in such a way that the user is required to touch the catheter for insertion. Any exposure of a catheter to a non-sterile environment prior to insertion increases the potential for bacteria to be deposited on the catheter, leading to an increased potential for the catheter user to develop a urinary tract infection (UTI). It would therefore be desirable for a hydrophilic intermittent catheter to be packaged in such a way that its hydrophilic coating could be activated while the catheter is still in the package, and so that the catheter may be manipulated and advanced through the packaging, allowing application of the catheter without the user having to touch the actual catheter.  
         [0004]     The present invention includes package instructions and cut or tear-zone product packaging features so that the need for the user to touch the hydrophilic intermittent catheter is either minimized or preferably entirely eliminated. In this manner, the cut or tear-zone product packaging features provide the ability to deliver a “no-touch” approach to catheter insertion.  
         [0005]     Some competitive hydrophilic intermittent catheters are packaged in water as ready-to-use catheters. Other competitive hydrophilic intermittent catheters are packaged with a water packet for easy activation of the hydrophilic coating on the surface in preparation for use of the catheter. For example, Rochester Medical Corporation has a configuration of this type in which the water packet is provided adjacent the insertion end of the catheter (i.e., the end remote from the funnel end), but the user is required to handle the catheter for urethral insertion by peeling open the funnel end of the product packaging and then removing the catheter by pulling directly on the funnel through the open end of the packaging. Because the user must insert the opposite (eyelet) end of the catheter into the urethra after removal from the product packaging, it will be appreciated that handling of the catheter by the user cannot be avoided.  
       SUMMARY  
       [0006]     The present invention can maintain the basis of packaging for a hydrophilic intermittent catheter (i.e., a catheter in water), but it provides a packaging configuration in which the user is instructed to remove a part of the packaging while allowing for the remaining packaging to be used as a no-touch applicator sleeve. The user prepares the packaged catheter by, first, rupturing a foil water packet that is included within a cavity that holds the catheter and, then, tipping the packaging back and forth in order to fully hydrate the hydrophilic intermittent catheter.  
         [0007]     In some embodiments, the packaging may include printed instructions for the user to cut (for example using user provided scissors) through a packaging heat seal edge joint perpendicular to the catheter&#39;s orientation along a line printed on the eyelet end of the packaging, which may include, for example, “Do Not Cut Beyond” indicia. After the packaging has been cut to the extent indicated by such indicia, the end of the packaging adjacent the eyelet end of the catheter can be removed by the user tearing it away from the remainder of the packaging.  
         [0008]     In another embodiment, the need for user cutting is eliminated by perforating the packaging to allow the user to tear through the heat seal in the same eyelet end of the packaging perpendicular to the catheter&#39;s orientation.  
         [0009]     In still another embodiment, notching is provided on opposite sides of the packaging. The notching allows the user to tear through the heat seal in the same eyelet end of the packaging perpendicular to the catheter&#39;s orientation. Specifically, the packaging can be provided with notching on either side of a designated separation region to thereby decrease the force needed to separate the end from the remainder of the packaging, while at the same time exposing the eyelet end of the catheter for insertion.  
         [0010]     In any of the foregoing packaging configurations, the user can proceed to hold the catheter firmly within the packaging in one hand and to hold the packaging proximal the opening formed near the eyelet end of the catheter in the other hand. The user may then initiate insertion of the exposed eyelet end of the catheter into the urethra while using the hand holding the packaging proximal the opening near the eyelet end to gradually slip the packaging away from the eyelet end toward the funnel end as the catheter is inserted further into the urethra. As a result, and without the need to touch the catheter, it will be understood that the insertion of the catheter is carried out by manipulating the catheter solely through handling of the packaging films as the catheter is inserted further into the urethra.  
         [0011]     Any of the embodiments of the present disclosure may be varied by including a peel-away sheet or wrapper portion. Printed instructions may also be provided to direct the user to peel open the packaging at the funnel end of the catheter to drain the water after the catheter has been fully hydrated, i.e. following the rupturing of the foil water packet and tipping of the sealed packaging back and forth.  
         [0012]     In certain embodiments, the printed instructions may further direct the user to grasp the funnel on the catheter and to pull the funnel end of the catheter a few inches out of the packaging through the end of the packaging that was peeled open to accommodate draining the water. The printed instructions may additionally direct the user to withdraw the funnel end of the catheter until the insertion end or tip of the catheter is spaced from the closed end of the packaging and is also spaced a short distance from the spent foil water packet. Next, the printed instructions may direct the user to tear or cut through the packaging between the spent foil water packet and the insertion end or tip of the catheter, for example along a notched tear line, a perforation, or a printed or scored cutting line, to separate the closed end (including the spent foil water packet) from the remainder of the packaging. Finally, the printed instructions may direct the user to grasp the funnel on the catheter and push the catheter back through the remaining packaging to expose the insertion end or tip through the cut end for no-touch application of the catheter using the packaging as an applicator sleeve.  
         [0013]     From the foregoing, it will be appreciated that the no-touch application methods and hydrophilic catheter packaging configurations disclosed herein permit the user to hold the catheter firmly within the packaging, and that in at least certain embodiments, the catheter may be held firmly within the packaging that remains after peeling open the packaging at the funnel end of the catheter, cutting or tearing the packaging to completely separate the closed end including the spent foil water packet, and pushing the catheter through the packaging to expose the insertion end or tip. The user may initiate insertion of the exposed insertion or eyelet end of the catheter into the urethra while using the hand holding the packaging to gradually slip the packaging away from the eyelet end toward the funnel end as the catheter is inserted further into the urethra. As a result, and without any need for the user to ever touch the catheter after the catheter and packaging have been prepared using the steps described above, and as explained further in the following detailed description of the preferred embodiments, the insertion of the catheter is carried out simply by manipulating the catheter solely through handling of the films that make up or are part of the packaging as the catheter is inserted further into the urethra.  
         [0014]     With the foregoing, the present invention overcomes the increased potential of UTIs that occurs with catheter handling. The “no-touch” approach of the present invention minimizes, and potentially eliminates, the UTI potential because it avoids or eliminates contamination of the catheter by bacteria on the hands of the user during insertion into the urethra. Further, the catheter&#39;s flexible silicone construction paired with the packaging allows the catheter to remain stable to make insertion easier for the user.  
         [0015]     By utilizing the “no-touch” application approach, the packaging facilitates insertion for softer catheters because gripping of the catheter through the films of the packaging serves to “stiffen” or stabilize the catheter as an aid to insertion. 
     
    
     DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING  
       [0016]      FIG. 1  is a top plan view of a package assembly for an intermittent hydrophilic catheter and pouch containing a lubricant;  
         [0017]      FIG. 2  is an elevation view of the package assembly of  FIG. 1 , wherein the pouch containing the lubricant has been ruptured;  
         [0018]      FIG. 3  is an elevation view of the package assembly of  FIG. 1 , showing separation of a first portion of the packaging surrounding the pouch containing the lubricant from a remaining portion of the packaging;  
         [0019]      FIG. 4  is an elevation view of the package assembly of  FIG. 1 , after the first portion of the packaging surrounding the pouch containing the lubricant has been completely removed from the remaining portion of the packaging, exposing a distal end of the catheter;  
         [0020]      FIG. 5  is a cross-sectional view taken along lines  5 - 5  of  FIG. 3 ;  
         [0021]      FIG. 6  is a top plan view of another embodiment of a package assembly for an intermittent hydrophilic catheter and pouch containing a lubricant;  
         [0022]      FIG. 7  is an elevation view of the package assembly of  FIG. 6 , wherein the pouch containing the lubricant has been ruptured;  
         [0023]      FIG. 8  is an elevation view of the package assembly of  FIG. 6  showing separation of a first portion of the packaging surrounding the pouch containing the lubricant from a remaining portion of the packaging;  
         [0024]      FIG. 9  is an elevation view of the package assembly of  FIG. 1 , after the first portion of the packaging surrounding the pouch containing the lubricant has been completely removed from the remaining portion of the packaging, exposing a distal end of the catheter;  
         [0025]      FIG. 10  is a top plan view of a third embodiment of a package assembly for an intermittent hydrophilic catheter and pouch containing a lubricant;  
         [0026]      FIG. 11  is an elevation view of the package assembly of  FIG. 10 , wherein the pouch containing the lubricant has been ruptured;  
         [0027]      FIG. 12  is an elevation view of the package assembly of  FIG. 10 , showing separation of a first portion of the packaging surrounding the pouch containing the lubricant from a remaining portion of the packaging;  
         [0028]      FIG. 13  is an elevation view of the package assembly of  FIG. 10 , after the first portion of the packaging surrounding the pouch containing the lubricant has been completely removed from the remaining portion of the packaging, exposing a distal end of the catheter;  
         [0029]      FIG. 14  is an elevation view of a fourth embodiment of a package assembly for an intermittent hydrophilic catheter and pouch containing a lubricant;  
         [0030]      FIG. 15  is an elevation view of the package assembly of  FIG. 14 , wherein the pouch containing the lubricant has been ruptured;  
         [0031]      FIG. 16  is an elevation view of the package assembly of  FIG. 14 , demonstrating a manner in which any of the package assemblies disclosed herein may be manipulated following rupture of the pouch containing the lubricant in order to activate the coating of the intermittent hydrophilic catheter;  
         [0032]      FIG. 17  is an elevation view of the package assembly of  FIG. 14 , showing the walls of packaging assembly peeled apart at a funnel end of the catheter;  
         [0033]      FIG. 18  is an elevation view of the package assembly of  FIG. 14 , showing the funnel end of the catheter pulled out through the peeled-apart opening of the packaging assembly;  
         [0034]      FIG. 19  is an elevation view of the package assembly of  FIG. 14 , showing the separation of a first portion of the packaging surrounding the pouch containing the lubricant from a remaining portion of the packaging; and  
         [0035]      FIG. 20  is an elevation view of the package assembly of  FIG. 14 , after the first portion of the packaging surrounding the pouch containing the lubricant has been completely removed from the remaining portion of the packaging, and showing the catheter being advanced through the remaining portion of the packaging for use. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0036]     In the embodiments illustrated in the several views of the drawing, the cut, perforated tear lines, and notched tear lines cause the eyelet end of the catheter to be exposed upon severing and removal of the end of the packaging. In alternative embodiments, the packaging is formed such that the cut, perforated tear lines, and notched tear lines are located beyond the eyelet end of the catheter upon severing and removal of the end of the packaging. If so formed, the catheter can be gripped through the packaging and manipulated by the user to cause the eyelet end to be exposed to initiate the insertion of the catheter into the urethra.  
         [0037]     A first embodiment of a packaging assembly  10  for an intermittent hydrophilic catheter  12  is shown in  FIGS. 1-5 . The packaging assembly includes a first sheet  14  and a second sheet  16 . The first sheet  14  and second sheet  16  are secured to one another at an edge seal  15 , for example by heat sealing, and the first and second sheets  14 ,  16  together define a catheter-receiving chamber  18 . A pouch  20  containing a lubricant  22 , such as water, is disposed within the catheter-receiving chamber  18 , and is located in a first end  24  of the chamber  18 . In this first embodiment, the catheter  12  has a distal end  26  also disposed in the first end  24  of the chamber  18 . The catheter  12  further includes a funnel  28  disposed on a proximal end  30  thereof. The proximal end  30  of the catheter  12  is located in a second end  32  of the catheter-receiving chamber  18 .  
         [0038]     The packaging assembly  10  is provided with at least one notch  34 , and preferably an opposing notch  36 . These notches  34 ,  36  facilitate tearing a portion  38  of the packaging assembly  10  containing the pouch  20  to separate that portion  38  from a remaining portion  40  of the packaging assembly  10 .  
         [0039]     The sheets  14 ,  16  of the packaging assembly  10  are preferably non-rigid, and may, for example, be made of foil. In order to activate a hydrophilic coating on the surface of the catheter  12 , a user firmly presses on the pouch  20 , which is preferably formed of an easily breakable foil, until it ruptures, thereby releasing lubricant  22  contained therein. Using a motion such as that illustrated in  FIG. 16 , the user then tilts the packaging assembly  10  back and forth, or otherwise maneuvers the packaging assembly  10 , in order to distribute the lubricant  22  over the entirety of the coated portion of the catheter  12 .  
         [0040]     Once the lubricant  22  is distributed over the coated portion of the catheter  12 , the catheter  12  is lubricated and ready for use. The user initiates a tear at one of the notches  34 ,  36 , separates the first portion  38  from the remaining portion  40  of the packaging assembly  10 , as shown in  FIG. 3 , and removes the first portion  38 , exposing the distal end  26  of the catheter  12 , as shown in  FIG. 4 . The user may then manipulate the catheter  12  through the walls  14 ,  16  of the packaging assembly  10  so as to introduce the catheter  12 , distal end  26  first, into the urethra.  
         [0041]     A second embodiment of the packaging assembly  100  is shown in  FIGS. 6-9 . As the second embodiment of the packaging assembly  100  has many elements in common with the first embodiment of the packaging assembly  10 , reference numbers in  FIGS. 6-9  representing common elements in the two embodiments are the same as the reference numbers in  FIGS. 1-5 , increased by a factor of 100, and so as to avoid repetition, a detailed discussion of all elements of the second embodiment of the packaging assembly  100  is omitted.  
         [0042]     The second embodiment of the packaging assembly  100  utilizes a perforation line  135  along which a first portion  138  of the packaging assembly  100  can be separated from the remaining portion  140  once the hydrophilic coating of a catheter  112  has been activated.  
         [0043]     A third embodiment of a packaging assembly  200  is illustrated in  FIGS. 10-13 . As with the second: embodiment, this third embodiment of the packaging assembly  200  has many elements in common with the first embodiment of the packaging assembly  10 . Thus, reference numbers in  FIGS. 10-13  representing common elements in the two embodiments are the same as the reference numbers in  FIGS. 1-5 , increased by a factor of 200, and so as to avoid repetition, a detailed discussion of all elements of the third embodiment of the packaging assembly  200  is omitted. The third embodiment of the packaging assembly  200  utilizes a pair of cutting lines  233 ,  237 . Once a user cuts the packaging assembly  200  along the cutting lines  233 ,  237  using, for example, a pair of scissors  250 , a remaining length  235  between a terminus of each of the cutting lines  233 ,  237  may be torn by the user to permit separation of a first portion  238  of the packaging assembly  200  from the remaining portion  240 , as shown in  FIG. 12 , once the hydrophilic coating of a catheter  212  has been activated. While cutting along the cutting lines  233 ,  237 , the user must exercise caution to avoid cutting any portion of the catheter  212 .  
         [0044]     Turning to  FIGS. 14-20 , a fourth embodiment of a packaging assembly  300  is shown. The fourth embodiment also has many elements in common with the first embodiment of the packaging assembly  10 , so reference numbers in  FIGS. 14-20  representing common elements in the two embodiments are the same reference numbers in  FIGS. 1-5 , increased by a factor of 300, and so as to avoid repetition, a detailed discussion of all elements of the fourth embodiment of the packaging assembly  300  is omitted.  
         [0045]     In this fourth embodiment, after activation of the hydrophilic coating, the first and second sheets  314 ,  316  of the packaging assembly  300  are pulled apart to permit drainage of the lubricant  322  from the chamber  318  and withdrawal of the funnel end  328  of the catheter  312 . By withdrawing the funnel  328  of the catheter  312  a short distance through an opening  352  created by pulling apart the first and second sheets  314 ,  316 , the distal end  326  of the catheter  312  is withdrawn from the first end  324  of the packaging assembly  300  containing the pouch  320 . By withdrawing the distal end  326  of the catheter  312  a sufficient distance from the first portion  338  of the packaging assembly  300 , a user may then cut the entire first portion  338  from the remaining portion  340  of the packaging assembly  300  without having to first cut through only a portion of the width of the packaging assembly, then tearing the remainder, as in the third embodiment.  
         [0046]     As shown in  FIG. 20 , after advancing the funnel end  328  back into the packaging assembly  310  to expose the distal or insertion end  326 , the catheter  312  is then ready for use. The remaining portion  340  of the packaging assembly may be used to manipulate the catheter  312  for insertion into the urethra without the user having to physically touch the lubricated body of the catheter  312 . Although the funnel end  328  of the catheter  312  is pulled out of the packaging assembly  300  prior to insertion of the catheter  312 , this limited exposure of the catheter  312  does not compromise the sterility of the insertable portion of the catheter  312 . The funnel end  328  of the catheter  312  is only pulled out of the packaging assembly  300  a sufficient distance so that the distal end  326  is pulled clear of the first portion  338  of the packaging assembly. No portion of the catheter  312  that physically comes into contact with the urethra is withdrawn through the opening  352  prior to insertion of the catheter  312 .  
         [0047]     As illustrated in  FIG. 5 , as a further aspect of the packaging of the present invention, the end of the packaging opposite the eyelet end of the catheter can be formed so it can be opened by the user in an easy fashion. This easy-open feature permits drainage of the lubricant after the catheter has been lubricated, and it also permits drainage of urine directly into the toilet through the funnel end of the catheter opposite the insertion end. For this purpose, the packaging may be formed such that the front and back walls  14 ,  16  extend unattached beyond the edge seal  15  to permit the walls, which may be made of foil, to be gripped by the user to peel open this end.  
         [0048]     Once this has been done, the end of the catheter  12  opposite the eyelet, or insertion, end (which may have a funnel  28 ) can be made to extend outwardly of the peeled-open packaging to accomplish the direct drainage of urine through the catheter into the toilet.  
         [0049]     With the foregoing understanding, it will be appreciated that the catheter tip can be made ready for insertion without the need to touch the catheter either by exposing it upon severing and removing the end of the packaging or by manipulating the catheter through the packaging to cause the tip to be clear of the packaging. Further, the packaging does not interfere with insertion and the user gets the added benefit of controlled no-touch insertion with the use of the packaging sleeve. Because of the ability to provide controlled, no-touch insertion using any of the foregoing forms of opening the packaging and exposing the eyelet end of the catheter, it is possible to overcome the problems associated with current hydrophilic intermittent catheters which are very slippery to touch and handle. It will also be appreciated that the invention is not limited to the embodiments described herein, and that variations may be made that are within the scope of the appended claims.