US 20050109648 A1
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
(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
4. The packaging assembly of
5. The packaging assembly of
6. The packaging assembly of
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
9. The method of
10. The method of
11. The method of
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
13. The method of
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.
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.
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.
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.
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.
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.
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'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.
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's orientation.
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'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.
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.
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.
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.
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.
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's flexible silicone construction paired with the packaging allows the catheter to remain stable to make insertion easier for the user.
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.
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.
A first embodiment of a packaging assembly 10 for an intermittent hydrophilic catheter 12 is shown in
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.
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
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
A second embodiment of the packaging assembly 100 is shown in
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.
A third embodiment of a packaging assembly 200 is illustrated in
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.
As shown in
As illustrated in
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.
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.