Patent Publication Number: US-2022211973-A1

Title: Methods of urging a catheter from a closed urinary catheter system

Description:
RELATED APPLICATIONS 
     The present application is a continuation of U.S. Ser. No. 16/295,733, filed Mar. 7, 2019, under the same title, now issued as U.S. Pat. No. 11,285,292, which is a continuation-in-part of U.S. Ser. No. 15/902,793, filed Feb. 22, 2018, under the same title, now issued as U.S. Pat. No. 10,226,594, the contents of which are expressly incorporated herein. 
    
    
     NOTICE OF COPYRIGHTS AND TRADE DRESS 
     A portion of the disclosure of this patent document contains material which is subject to copyright protection. This patent document may show and/or describe matter which is or may become trade dress of the owner. The copyright and trade dress owner has no objection to the facsimile reproduction by anyone of the patent disclosure as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright and trade dress rights whatsoever.  
     FIELD 
     The present invention relates to a closed intermittent catheter system and, more particularly, to a closed system with a shaped bag that facilitates gripping and advancement of a catheter therein. 
     BACKGROUND 
     People with neurogenic bladder disorders like spinal cord injury, spina bifida or multiple sclerosis, and non-neurogenic bladder disorders like obstruction due to prostate enlargement, urethral strictures or post-operative urinary retention, need to be continuously catheterized to empty their urinary bladders. But such continuous catheterization can lead to problems like urinary tract infections (UTI), urethral strictures or male infertility. Intermittent catheterization at regular intervals avoids such negative effects of continuous long term catheterization. Research has shown that intermittent self-catheterization helps reduce urinary tract infections, control urinary leakage (incontinence) and prevent urinary tract damage. 
     In our highly mobile culture, the ability to have the freedom to leave home for the day or longer is an important part of life. To accommodate this need, single use intermittent urinary catheters have been developed to allow patients to perform self-catheterization. Many intermittent catheters are designed to be inserted into the bladder while the back end is suspended over a toilet or other waste receptacle. A closed system catheter is a self-contained, sterile, pre-lubricated catheter housed within a collection bag. The collection bag eliminates the need to void the urine into a receptacle or toilet, and since it&#39;s self-contained, it eliminates the need to hook up any other kind of bag or container. The closed system is also critical for a sterile intermittent catheter insertion technique whereby the catheter is inserted without human touch. 
     Despite numerous products on the market, there remains a need for an easier to use sterile closed intermittent urinary catheter system. 
     SUMMARY OF THE INVENTION 
     The present application discloses a sterile closed intermittent urinary catheter system which is an easier to use by virtue of ergonomic shaping to facilitate advancement and retrieval of the catheter from the collection bag. In a preferred embodiment, a closed internal hole in the bag adjacent an indent in one edge creates a narrow channel through which the catheter passes. The narrow channel is located near to and in alignment with an outlet assembly so that the catheter extends from the narrow channel directly to the outlet. A user may easily grasp the catheter from outside the bag at the narrow channel and urge the catheter forward or backward to alternately extend and retract it through the outlet. A flexible pusher sleeve with gripper features may be added around the narrow channel to further facilitate catheter advancement. 
     In one embodiment, a catheter closed urinary catheter system comprises a flexible generally rectangular collection bag defining a collection volume therein. The collection bag is substantially flat when empty and has an outlet in one longitudinal end. The collection bag further has an internal through hole in its middle portion and an indent in one lateral side adjacent the through hole that creates a narrow internal channel close to and generally aligned with the outlet. An intermittent urinary catheter sealed within the collection bag has a forward end located at the outlet and an adjacent portion passing through the narrow channel of the bag so that a user may grip the catheter from outside the bag at the narrow channel and urge the catheter forward or backward to alternately extend and retract it through the outlet. 
     The internal through hole may be an oval shape with a long axis aligned with the narrow internal channel. A flexible sleeve may be fitted around the narrow channel and having frictional features thereon for enhanced gripping of the catheter. 
     Another closed urinary catheter system comprises a flexible generally rectangular collection bag defining a collection volume therein. The collection bag is substantially flat when empty and has an outlet in one longitudinal end. The collection bag further defines a narrow bridge close to and generally aligned with the outlet and having an open passage therethrough. An intermittent urinary catheter sealed within the collection bag has a forward end located at the outlet and an adjacent portion passing through the open passage defined by the narrow bridge. A flexible sleeve fits around the narrow channel and has frictional features thereon for enhanced gripping of the catheter, wherein a user may grip the catheter from outside the bag using the sleeve and urge the catheter forward or backward to alternately extend and retract it through the outlet. 
     In either system outlined above, the flexible sleeve is desirably silicone and is formed in an open tubular structure with two free edges; which edges may overlap. The frictional features may include grooves which define circumferential raised regions therebetween or a roughened or textured outer surface. 
     A feed lock may be included within the outlet of the bag of either system which allows free forward passage of the catheter out of the bag but hinders retraction of the catheter. Preferably, the outlet comprises a relatively rigid gripping hub through which the catheter passes. Further, an introducer tip may extend from an outer end of the outlet through which the catheter passes, with a sterile cap secured over the introducer tip. Finally, a gel reservoir may be secured within the hub that lubricates the catheter as it passes through the reservoir. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a front view of an exemplary sterile closed intermittent urinary catheter system having a narrow channel formed in a collection bag to facilitate feeding of a catheter therefrom; 
         Figure 1A  is a front view of a catheter system similar to  FIG. 1  with a through hole moved to permit alignment of the catheter with an outlet assembly; 
         FIG. 1B  is a front view of a catheter system similar to  FIG. 1  with two through holes flanking a centered channel through which the catheter passes; 
         FIG. 2  is a front view of an alternative sterile closed intermittent urinary catheter system similar to that shown in  FIG. 1  with an ergonomic sleeve positioned around the narrow channel to further facilitate feeding of a catheter therefrom; 
         FIGS. 3A and 3B  are front views of the system of  FIG. 2  illustrating two stages in the use thereof; 
         FIG. 4A  is a sectional view taken along line  4 - 4  in  FIG. 2  showing one embodiment of the ergonomic sleeve, and  FIG. 4B  is a similar view showing an alternative ergonomic sleeve; and 
         FIG. 5  is an exploded view of exemplary components provided at an outlet of the closed intermittent urinary catheter systems disclosed herein. 
     
    
    
     DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT 
     The present application provides a sterile closed intermittent urinary catheter system which is an easier to use by virtue of ergonomic shaping to facilitate advancement and retrieval of the catheter from the collection bag. The catheter is advanced by hand through manipulation from outside the bag. 
       FIG. 1  is a front view of an exemplary sterile closed intermittent urinary catheter system  20  having a flexible, preferably transparent, collection bag  22  with a generally rectangular profile and defining a collection volume therein. The shape has a length dimension L between longitudinal ends and a width dimension W between lateral sides, as shown in  FIG. 2 . An intermittent catheter  24  is stored in the bag, and may be 14 or 16 inches in length. The collection bag  22  is generally shorter in length than the catheter  24  so that the catheter is curled or coiled therein. In one embodiment, the length dimension L is about 415-425 mm, and the width dimension W is about 125-135 mm, or in other words the bag  22  is roughly 3-4 times longer than it is wide. 
     The collection bag  22  has an outlet at one longitudinal end including an outlet hub  26 . The bag  22  is formed of a suitable flexible polymer such as polyethylene, while the hub  26  is a rigid polymer and has a larger and easy-to-grip external shape as shown. The bag  22  is desirably formed by heat-sealing or otherwise affixing peripheral edges of two faces or panels together, as well as around the hub  26 , in a manner which ensures sterility of the internal collection volume or cavity thus formed. Preferably, the two panels are identical (matching). Securing the two faces together at their edges thus results in a relatively flat, 2D bag when empty, though of course the bag expands to a 3D shape when the collection volume fills with urine. 
     A sterile closure  28  affixes over an outlet opening (not shown) in the hub  26  and may be provided with a grip, handle or ring such as shown at  30  for easy removal. A distal tip  32  of the catheter is seen in phantom located within the hub  26 , just inside the outlet opening, which is its shipped position prior to use. 
     The collection bag  22  also has an internal through hole  40  (internal meaning closed to the outer edges of the bag) defined by inner edges of the bag material secured together in an oval shape such as by heat sealing. The through hole  40  terminates near to the longitudinal outlet end of the bag  22 , preferably within an inch or two, and may be centered (or approximately centered) along midplane MP of the width dimension W of bag. A narrow bridge  42  is formed in the collection bag  22  by the through hole  40  and an adjacent seam formed by the two matching panels sealed together; in this embodiment an indented section  44  in one lateral side of the bag  22 . The faces of the bag  22  are not attached to each other along the bridge  42  so that a narrow open channel or passage in the collection volume is thus formed. The oval internal through hole  40  has a long axis aligned with the narrow internal channel. The indented section  44  may comprise a generally trapezoidal indent as shown, or may be more rectangular or more rounded, as desired. The catheter  24  passes through the narrow channel formed in the bridge  42  which facilitates feeding of the catheter from the bag  22 , as will be described. First, a complete description of the preferred system components is helpful. 
       Figure 1A  is a front view of a catheter system similar to  FIG. 1  with the through hole  40  moved farther away from the indented section  44  to permit longitudinal alignment of the narrow open channel or passage and catheter  24  with the outlet hub  26 . The through hole  40  is still adjacent the midplane MP, and the outlet hub  26  is now centered along the midplane MP. Aligning the catheter  24  with the outlet hub  26  in this manner facilitates movement of the catheter out of the collection bag  22  by reducing any frictional impediment from misalignment or bending of the catheter through the narrow channel. In all other respects, the collection bag  22  is the same as described above so that like elements are given like part numbers. 
       FIG. 1B  is a front view of a catheter system similar to  FIG. 1  with two through holes  40 ,  41  flanking the bridge  42  to form the narrow open channel or passage in the collection volume along the midplane MP. The outlet hub  26  is again centered along the midplane MP. In this embodiment there is no indented section  44  in one lateral side wall, both lateral side walls are straight. Instead, the two through holes  40 ,  41  both form seams between the matching panels, and the two closest or adjacent seams define the narrow bridge  42  and channel. Desirably, the two through holes  40 ,  41  are identical and spaced equidistantly across the longitudinally-extending midplane M of the collection bag. The through holes  40 ,  41  also provide handles of sorts for the user to manipulate the collection bag  22 . In all other respects, the collection bag  22  is the same as described above so that like elements are given like part numbers. 
       FIG. 2  is a front view of an alternative sterile closed intermittent urinary catheter system  20 ′ similar to that shown in  FIG. 1 . The only change from the system  20  in 
       FIG. 1  is the addition of an ergonomic pusher sleeve  46  having grooves  48  positioned around the narrow bridge  42  to further facilitate feeding of the catheter  24  from the bag  22 . 
       FIG. 2  shows the closure  28  removed from the hub  26  to expose an introducer tip  50 . The distal tip  32  of the catheter preferably resides just inside the introducer tip  50  when packaged. Internal components of the outlet end of the bag  22  are shown exploded in  FIG. 5  and include a rigid sleeve  52  through which the catheter  24  passes, a catheter feed lock  54 , and a lubricating gel reservoir  56 . Prior to exiting the bag  22 , the catheter passes through all three of these components. It should be noted that rather than providing the lubricating gel reservoir  56 , the catheter  24  may be pre-lubricated along its length, or may be provided with a dry hydrophilic coating which, when wetted, becomes lubricious. In the latter case, a small sachet of water is provided within the bag  22  which, when ruptured, wets the catheter  24 . 
       FIGS. 3A and 3B  are front views of the system  20 ′ of  FIG. 2  illustrating two stages in the use thereof. After removal of the outlet closure  28  and prior to longitudinal advancement of the catheter  24  from the bag  22 , the user inserts the introducer tip  50  into the urethra (men or women). The user then advances the catheter  24  forward, as indicated by the arrow, by pinching it with the relatively flexible pusher sleeve  46  through the bag  22  and urging it forward while holding the outlet hub  26  steady. The introducer tip  50  is made of a flexible elastomer which has petals that the catheter tip  32  spreads apart upon passage therethrough. The introducer tip  50  helps prevent any bacteria that may be around the urethra opening from contacting the catheter tip  32 , which in turn helps reduce instances of infection. The user continues to slowly push the catheter  24  through the introducer tip  50  and into the urethra until the catheter reaches the bladder and urine begins to flow. The catheter  24  has one or more small eyelets  34  at its distal tip  32  into which the urine flows. The lubricated nature of the catheter  24  eases the insertion. 
     When fully inserted, the system  20 ′ may be in the configuration shown in  FIG. 3B  with the catheter  24  nearly fully extended out of the bag  22 . The double-headed arrow shown on the pusher sleeve  46  indicates the ability to adjust the final longitudinal position of the catheter  24 . An enlarged collar  58  attached to a rear end of the catheter  24  is sized so as to be unable to pass through the rigid sleeve  52  on the inner end of the outlet assembly which serves as a safety measure to prevent full extraction of the catheter  24  from the bag  22 . 
     The pusher sleeve  46  acts as a grip of sorts around the catheter  24  within the bag. The pusher sleeve  46  is desirably made of a soft elastomer so that it may be easily squeezed and deform around the catheter  24 . In the configuration shown, the sleeve  46  desirably has circumferential grooves that create circumferential raised regions therebetween which enhance the friction between the user&#39;s hand and the sleeve. Of course, other means of doing the same thing are contemplated, such as a roughened or textured outer surface, bumps, extremely soft foam, etc. 
     Furthermore, it should be noted that the sleeve  46  is added merely to enhance the grip of the user on the catheter  24 , but that it is the shape of the collection bag  24  in the first place that facilitates catheter advancement. In particular, passage of the catheter  24  through the narrow channel formed in the bridge  42  seen in  FIG. 1  close to the outlet end of the bag is the main improvement. With reference back to  FIG. 1 , the channel formed in the bridge  42  is generally aligned with the central axis of the outlet hub  26  and its components, so that the catheter  24  can easily be advanced from the bag  22  by gripping it at the channel and urging it forward relative to the hub. Although bags without the through hole  40 , bridge  42  and indent  44  are available and the general process of advancing a catheter therefrom is the same (gripping the catheter through the bag), certain difficulties arise. First, the user may grip the catheter too far from the outlet, which may cause the catheter to bend and reduces pushing force. Second, the user may not push the catheter  24  in alignment with the outlet, which also reduces leverage. Finally, the mere task of gripping the catheter between two generally flat bag panels may not be easy, especially for those with dexterity challenges. The narrow bridge  42  located close to and in alignment with the outlet hub  26  greatly reduces these potential hindrances, and may be a big improvement for some users. 
     The pusher sleeve  46  is preferably a loose part that fits around the narrow bridge  42 , though it may also be adhered thereto. Since the sleeve  46  passes through the closed through hole  40 , it cannot prior to assembly on the bag  22  be formed as a closed tube. There are several solutions in this regard.  FIG. 4A  is a sectional view taken along line  4 - 4  in  FIG. 2  showing one embodiment of the ergonomic pusher sleeve  46 . The sleeve  46  may be formed in generally an oval tube with two abutting free edges coming together at  60 . The tube of the sleeve  46  fits closely around the lenticular-shaped portion of the bag  22  that forms the bridge  42 , with the catheter  24  shown therein.  FIG. 4B  is an alternative ergonomic sleeve  46  which also defines an oval-shaped tube with two somewhat overlapping free edges  62 . Of course, variations of these configurations are well within the level of skill in the art. 
     Finally,  FIG. 5  shows a few more details of the components at the outlet of the closed systems  20  disclosed herein. First, a generally cylindrical rigid housing  64  may attach to the inner end of the hub  26  and provide a cavity therein for the feed lock  54 . The feed lock  54  functions to permit one-way forward advancement of the catheter  24 , but inhibits rearward movement thereof. In one embodiment, a cylindrical housing with a throughbore provides support for a thin flap  72  that attaches to the housing via a living hinge. Although not shown, the flap  72  has a throughbore as well and receives the tubular catheter  24  therethrough. When the catheter  24  advances forward, the flap  72  is pushed to an orientation perpendicular to the longitudinal direction, which eases passage of the catheter through its therethrough. Conversely, when the catheter  24  is displaced rearward, the flap  72  assumes the angled orientation shown which tends to resist movement of the catheter by virtue of the now-angled throughbore. A latch may be provided to enable a user to fix the flap  72  against the housing  70  to permit retraction of the catheter  24 . Similar devices are disclosed in co-pending U.S. patent application Ser. No. 15/671,341, the contents of which are hereby expressly incorporated by reference. 
       FIG. 5  also illustrates an internal chamber  74  of the lubricating gel reservoir  56  which resides between two end openings  76  sized slightly larger than the tubular catheter  24 . As seen in  FIG. 1 , the distal tip  32  of the catheter  24  preferably sits within the lubricating medium in the chamber  74  prior to use. Of course, other reservoirs are contemplated, such as the resilient reservoirs disclosed in U.S. Pat. No. 9,833,592, the contents of which are hereby expressly incorporated by reference. 
     Throughout this description, the embodiments and examples shown should be considered as exemplars, rather than limitations on the apparatus and procedures disclosed or claimed. Although many of the examples presented herein involve specific combinations of method acts or system elements, it should be understood that those acts and those elements may be combined in other ways to accomplish the same objectives. Acts, elements and features discussed only in connection with one embodiment are not intended to be excluded from a similar role in other embodiments.