Abstract:
Flexible packaging with an integrated component for controlled dispensing of a flexible elongate tubular product, such as a catheter, retained within the packaging. The dispensing control device is disposed at one end of the packaging and includes a housing and a locking member. The housing member is attached to one end of the packaging and provides a linear exit passageway through the packaging. The locking member is hingedly attached to the housing within the product retention chamber, and has an orifice that extends through the locking member. The locking member is pivotable relative to the housing as between a first dispensing position wherein the central axis of the orifice is aligned with the central axis of the passageway, and a second locked position wherein the central axis of the orifice is misaligned with the central axis of the pathway through the housing.

Description:
BACKGROUND 
       [0001]    Intermittent catheters are typically used by patients suffering from urinary incontinence or by individuals unable to have voluntary urination. 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 catheters have been developed to allow patients to perform self catheterization. To aid in the insertion of the catheter in a body cavity they are often lubricated making the handling of the catheter difficult and messy. Many catheter packages are now designed to aid in the use of the catheter and at least the funnel end of the catheter is retained in the package. This allows the user to use the package to manipulate the catheter and avoid the messy and possible insanitary handling of the actual catheter. Manipulating a slippery catheter through a plastic bag can be quite difficult even for someone with excellent dexterity. To aid in the manipulation of the catheter various devices have been conceived to limit or control the movement of the catheter into and out of its package. 
         [0002]    Many of these movement control devices have multiple parts increasing cost, weight, and waste of the overall catheter and packaging. 
         [0003]    Therefore, a need exists for a low cost, lightweight, and low waste catheter movement control device. 
       SUMMARY OF THE INVENTION 
       [0004]    A first aspect of the invention is an intermittent urinary catheter packaging having a longitudinally extending package and a catheter movement control device. The catheter movement control device is disposed within the package and has a monolithic planar locking member and a one-way valve. The monolithic locking member has longitudinally spaced upper and lower surfaces, laterally spaced ends, and transversely spaced front and back edges. The valve is disposed through the upper and lower surfaces of the locking member and configured and arranged for receipt of the catheter tube and to advance the tube through the locking member in the first longitudinal direction only. 
         [0005]    A second aspect of the invention is flexible packaging with an integrated component for controlled dispensing of a flexible elongate tubular product retained within the packaging. The dispensing control device is disposed at one end of the packaging and includes a housing and a locking member. The housing member is attached to one end of the packaging and provides a linear exit passageway through the packaging. The locking member is hingedly attached to the housing within the product retention chamber, and has an orifice that extends through the locking member. The locking member is pivotable relative to the housing as between a first position wherein the central axis of the orifice is aligned with the central axis of the passageway, and a second position wherein the central axis of the orifice is misaligned with the central axis of the pathway through the housing. 
         [0006]    A third aspect of the invention is a packaged intermittent urinary catheter that includes an intermittent urinary catheter, packaging retaining the intermittent urinary catheter, and a catheter movement control device. The catheter movement control device is disposed at one end of the packaging and includes a housing and a locking member. The housing is attached to one end of the packaging and has (−) longitudinally spaced opposed first and second ends with the first end disposed outside the receiving chamber and the second end disposed inside the receiving chamber, (−) a pathway extending through the housing between the first and second ends defining an exit port through which the catheter retained within the receiving chamber of the packaging may be withdrawn from the packaging, and (−) a pair of laterally spaced tabs extending longitudinally from the second end of the housing, positioned on diametric sides of the pathway. The locking member has (˜) an orifice located between first and second ends of the locking member, configured and arranged to frictionally engage the catheter so as to accommodate passage of the catheter through the orifice when the catheter is axially aligned with the orifice, while inhibiting passage of the catheter through the orifice when the catheter is axially misaligned with the orifice, and (˜) a hinge connecting the first end of the locking member to a distal end of one of the tabs for allowing pivoting of the locking member relative to the housing upon axial movement of the catheter when frictionally engaged within the orifice of the locking member as between a first position wherein the second end of the locking member contacts the distal end of the other tab and the central axis of the orifice through the locking member aligns with the central axis of the pathway through the housing, and a second position wherein the second end of the locking member is spaced from the distal end of the other tab and the central axis of the locking member is misaligned with the central axis of the pathway through the housing. Such pivoting of the locking member permits withdrawal of the catheter from the packaging through the passageway in the housing, while inhibiting return of a withdrawn length of the catheter into the packaging. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1  is a front plan view of the invention with a first embodiment of the movement control device. 
           [0008]      FIG. 2  is a front plan view of the invention in  FIG. 1  shown with the catheter moving in the first longitudinal direction as the user advances the catheter into the exit of the package. 
           [0009]      FIG. 3  is a front plan view of the invention in  FIG. 3  with the movement control device engaging the housing to prevent movement in the second longitudinal direction. 
           [0010]      FIG. 4  is a top plan view of the monolithic planar locking member shown in  FIG. 1 . 
           [0011]      FIG. 5  is an enlarged front plan view of the longitudinally extending posts shown in  FIG. 3 . 
           [0012]      FIG. 6  is a front plan view of a second embodiment of the movement control device. 
           [0013]      FIG. 6 a    is top view of the catheter movement control device along the line A-A of  FIG. 6  wherein the transversely spaced front and back edges are attached to the longitudinal sides of the package. 
           [0014]      FIG. 7  is a front plan view of a third embodiment of the catheter movement control device in the package. 
           [0015]      FIG. 8  is a front plan view of the catheter movement control device in  FIG. 7  with the movement control device engaging the housing to prevent movement in the second longitudinal direction. 
           [0016]      FIG. 9  is a side plan view of a fourth embodiment of the catheter movement control device with a back edge hingedly attached to a longitudinal side of the package. 
           [0017]      FIG. 10  is a perspective view of a fifth embodiment of the catheter movement control device with the locking mechanism pivoted into a second locking position. 
           [0018]      FIG. 11  is a side view of the catheter movement control device depicted in  FIG. 10  with dimensions for a particular embodiment set forth in mm. 
           [0019]      FIG. 12  is an end view of the catheter movement control device depicted in  FIG. 10  with dimensions for a particular embodiment set forth in mm. 
           [0020]      FIG. 13  is a cross-sectional side view of the catheter movement control device depicted in  FIG. 12  taken along line  13 - 13  and with dimensions for a particular embodiment set forth in mm. 
           [0021]      FIG. 14  is a cross-sectional side view of the catheter movement control device depicted in  FIG. 13  with the locking mechanism pivoted into the first dispensing position. 
       
    
    
     DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT 
     Nomenclature 
       [0000]    
       
           10  Catheter Packaging 
           20  Package 
           21  Longitudinally Extending Side 
           22  Exit 
           23  First Longitudinal End 
           24  Second Longitudinal End 
           25  Receiving Chamber 
           26  Line of Weakness 
           30  Movement Control Device 
           40  Monolithic Planar Locking Member 
           41   a  Upper Surface 
           41   b  Lower Surface 
           42  Lateral End 
           421  First or One Lateral End of Locking Member 
           422  Second or Other Lateral End of Locking Member 
           43   a  Front Edge 
           43   b  Back Edge 
           44  Locking Orifice 
           45  Snap Fit Latch 
           46  Hinge 
           50  Valve 
           51  Valve Orifice 
           51   CA  Central Axis of Valve Orifice 
           60  Housing 
           61  Longitudinal Axis 
           62  Pathway 
           62   CA  Central Axis of Pathway 
           63  First Longitudinally Extending Engagement Member 
           64  Second Longitudinally Extending Engagement Member 
           65  Slots or Catches 
           66  First Longitudinal End 
           67  Second Longitudinal End 
           68  Cap or Seal 
           70  Catheter 
           71  Lumen End 
           72  Funnel End 
           80  Lubricant 
         X 1  First Longitudinal Direction 
         X 2  Second Longitudinal Direction 
         Y Lateral Direction 
         Z Transverse Direction 
       
     
       DESCRIPTION 
     Construction 
       [0063]    The invention is catheter packaging  10  with a package  20  and a catheter movement control device  30 . The package  20  has a first longitudinal end  23  and a second longitudinal end  24  and defines a longitudinally elongate catheter receiving chamber  25  extending along a portion of the full longitudinal length of the package  20  configured to contain at least part of a catheter  70 . Preferably the entire catheter  70  is carried in the elongate receiving chamber  25  with the lumen end  71  of the catheter  70  located proximate the first longitudinal end  23  of the package  20  and the funnel end  72  proximate the second longitudinal end  24  of the package  20 . 
         [0064]    As shown in  FIG. 1 , a preferred embodiment of the package  20  may be constructed from a base sheet of material and cover sheet of material sealed along the edges to form the catheter receiving chamber  25  therein. The first longitudinal end  23  and the second longitudinal end  24  are sealed after insertion of the catheter  70  and movement control device  30  in the receiving chamber  25 . A second embodiment of the package  20  may also be constructed from a single base material folded upon it to provide a single sealed longitudinal edge. The first longitudinal end  23  and second longitudinal end  24  are then sealed after insertion of the catheter  70  and movement control device  30  in the receiving chamber  25 . In a third embodiment the package  20  may be extruded in a tube shape and then the first longitudinal end  23  and second longitudinal end  24  sealed after insertion of the catheter  70  and movement control device  30  in the receiving chamber  25 . 
         [0065]    The catheter  70  inserted in the package  20  is an intermittent catheter  70 . The catheter  70  may be coated with a hydrophilic coating to provide a low friction surface when treated with a swelling medium. A swelling medium may be provided within the package  20  to provide a ready to use catheter  70 . A lubricant  80  may also be provided in the package  20  to provide a low friction surface. 
         [0066]    The catheter  70  may have any desired longitudinal length and shape effective for achieving the function of eliminating urine from the bladder of a male or female patient. Preferably, the longitudinal length for an adult female catheter  70  is between 2-6 inches, the longitudinal length of the adult male catheter  70  is between 10-16 inches, and the longitudinal length of a pediatric catheter  70  is between 5-11 inches. 
         [0067]    The catheter receiving chamber  25  also contains within it a catheter movement control device  30 . The catheter movement control device  30  has a monolithic planar locking member  40  and a one-way valve  50 . The locking member  40  has longitudinally spaced upper and lower surfaces  41   a  and  41   b,  laterally spaced ends  42 , and transversely spaced front and back edges  43   a  and  43   b.  The locking member  40  may be made from any suitable thin and lightweight material. Preferably the locking member  40  is made of a heavy flexible polyvinyl chloride (PVC) film. 
         [0068]    The locking member  40  has a one-way valve  50  disposed through the upper and lower surfaces  41   a  and  41   b  of the locking member  40  as shown in  FIGS. 1, 4, 6A, and 9  to allow movement of the catheter  70  through the locking member  40  in the first longitudinal direction X 1  but not the second longitudinal direction X 2 . Any type of one way valve  50  may be utilized. Preferably a tricuspid or quadricuspid valve  50  is used. The valve  50  is sized and shaped to allow the catheter 70  to move freely through the locking member  40  in the first longitudinal direction X 1  and not the second longitudinal direction X 2 . 
         [0069]    The catheter movement control device  30  may also have a catheter housing  60 . The housing  60  has a first longitudinal end  66  and a second longitudinal end  67 . Preferably the housing  60  is attached to at least one of the longitudinally extending sides  21  of the package  20 . Most preferably the housing  60  is positioned within the exit  22  to the package  20  as shown in  FIG. 1  with the first longitudinal end  66  of the housing  60  allowing the catheter  70  to exit from the package  20  and the second longitudinal end  67  of the housing  60  within the receiving chamber  25 . The housing  60  has a longitudinal axis  61  and defines a longitudinally extending pathway  62  through the housing  60 . The pathway  62  is sized and configured for receipt of the catheter  70 . The housing  60  is disposed a longitudinal distance from the valve  50  in the first longitudinal direction X 1 . The housing  60  may also be disposed a longitudinal distance for the first longitudinal end  23  of the package  20 . 
         [0070]    In a second embodiment of the housing  60 , the housing  60  has one or two longitudinally extending and laterally spaced engagement members  63  and  64  extending in the second longitudinal direction X 2  from the second longitudinal end  67  of the housing  60 . See  FIGS. 1-3 . The engagement member may be any shape and size to allow engagement with corresponding locking orifices  44  disposed through the upper and lower surfaces  41   a  and  41   b  of the locking member  40  shown in  FIG. 4 . Preferably the engagement members  63  and  64  are post shaped members  63  and  64  as shown in  FIG. 5 . Preferably the housing  60  is made from a lightweight plastic. 
         [0071]    In a third embodiment of the housing  60 , the housing  60  has two laterally spaced slots or catches  65  in the second longitudinal end  67  configured and arranged to snap fit with the locking member  40 . In this embodiment the locking member  40  has a snap fit latch  45  extending in the first longitudinal direction X 1  on the first and second lateral ends  42  as shown in  FIGS. 7 and 8 . The snap fit latches  45  are configured and arranged to deflect and snap into the slot or catch  65  of the housing  60  to prevent movement of the locking member  40  in the second longitudinal direction X 2 . 
         [0072]    The monolithic planar locking member  40  may also be attached to a longitudinally extending side  21  of the package  20 . Either the lateral ends  42  or the front and back edges  43   a  and  43   b  can be attached to the package  20 . As shown in  FIGS. 6 and 6A , the transversely spaced front and back edges  43   a  and  43   b  of the locking member  40  may be welded to the package  20  to prevent the locking member  40  from moving in the longitudinal direction relative to the package  20 . As shown in  FIG. 9 , either the front edge  43   a  or back edge  43   b  may be hingedly attached to the package  20 . 
       Use 
       [0073]    The packaged intermittent urinary catheter  10  is used by patients for self catheterization. Prior to use the patient should take all sanitary procedures advised by their doctors to decrease the risks of infection from utilizing a catheter  10 .
       No Housing       
 
         [0075]    In the embodiment of the invention shown in  FIG. 6 , the package  20  has no housing  60  at the first longitudinal end  23 . To open the package  20  to access the catheter  70 , the patient grasps the first longitudinal end  23  of the package  20  and removes the end  23 . The end  23  may be removed by cutting with a knife or scissors, but preferably the end  23  is removed manually along a line of weakness  26 . By removing the first longitudinal end  23  at the point of weakness or line of weakness  26 , the package  20  will open such that the receiving chamber  25  is now open. 
         [0076]    The second longitudinal end  24  of the package  20  may also be removed to allow the package  20  to be used as an extended drainage tube or left intact so that the package  20  can be used as collection vessel. The second longitudinal end  24  may be removed by cutting with a knife or scissors, but preferably the end  24  is removed manually along a line or point of weakness  26 . 
         [0077]    Both the front edge  43   a  and back edge  43   b  of the locking member  40  are attached or fused to the longitudinally extending sides  21  of the package  20  preventing any longitudinal movement of the locking member  40 . The user grasps the catheter  70  below the locking member  40  (near the funnel end  72 ) and urges the catheter  70  in the first longitudinal direction X 1  through the locking member  40  until the lumen end  71  of the catheter  70  advances out of the package  20 . The catheter  70  continues to be advanced out of the package  20  and into the urethra of the user. If the catheter  70  encounters resistance advancing in the first longitudinal direction X 1 , the one-way valve  50  in the locking member  40  grabs the catheter  70  and prevents it from moving in the second longitudinal direction X 2 .
       Housing       
 
         [0079]    If the package  20  has a housing  60  located within the exit  22  of the package  20 , a seal or cap  68  covers the opening out of the housing  60 . See  FIGS. 1, 2 and 7 . The seal or cap  68  is removed to open the pathway  62  through the housing  60  and catheter receiving chamber  25 .
       Locking Member Attached to Package       
 
         [0081]    In the embodiment of the invention shown in  FIG. 9 , the movement control device  30  includes a housing  60 . Only one edge of the locking member  40  is attached to a longitudinally extending side  21  of the package  20 . Preferably this attached edge is hingedly attached. This allows the other edge to move in both the first longitudinal direction X 1  and the second longitudinal direction X 2 . The user grasps the catheter  70  below the locking member  40  (near the funnel end  72 ) and urges the catheter  70  in the first longitudinal direction X 1  through the locking member  40  until the lumen end  71  of the catheter  70  advances out of the package  20 . The catheter  70  continues to be advanced through the pathway  62  of the housing  60  and out of the package  20  and into the urethra of the user. If the catheter  70  encounters resistance advancing in the first longitudinal direction X 1 , the one-way valve  50  in the locking member  40  grabs the catheter  70  and prevents it from moving in the second longitudinal direction X 2 . As the catheter  70  is advanced, the unattached edge of the locking member  40  moves with the catheter  70  until it comes into contact with the housing  60 . This contact prevents the unattached edge of the locking member  40  from continuing to advance in the first direction and preventing movement in the first longitudinal direction X 1  of the catheter  70  through the one way valve  50 . The lumen end  71  of the catheter  70  is advanced through the pathway  62  through the housing  60  and out of the package  20 .
       Locking Member Attached To Housing       
 
         [0083]    In the embodiment of the invention shown in  FIGS. 1-3, 7-8 and 10-13  the user grasps the catheter  70  through the package  20  below the locking member  40  and manually urges the catheter  70  in the first longitudinal direction X 1  toward the housing  60 . As the lumen end  71  of the catheter  70  moves toward the housing  60 , the locking member  40  also advances toward the housing  60 . The lumen end  71  of the catheter  70  is urged into the pathway  62  of the housing  60  and the upper surface  41   a  of the locking member  40  is urged into contact with the second longitudinal end  67  of the housing  60 . 
         [0084]    In the embodiment of the invention shown in  FIGS. 1-3 , the housing  60  has first and second longitudinally extending engagement members  63  and  64  extending in the second longitudinal direction X 2  from the housing  60 . The engagement members  63  and  64  snap fit into locking orifices  44  in the locking member  40  preventing the locking member  40  from moving out of contact with the housing  60  member. In the embodiment of the invention shown in  FIGS. 7 and 8 , the housing  60  has slots or catches  65  in the second longitudinal end  67 . The locking member  40  has snap fit latches  45  extending in the first longitudinal direction X 1  on the first and second lateral ends  42  that are configured and arranged to mate with the slots or catches  65  in the housing  60 . In both embodiments the catheter  70  and the locking member  40  are advanced in the first longitudinal direction X 1 . The lumen end  71  of the catheter  70  enters the pathway  62  to advance out of the package  20  and the locking member  40  snap fits into place with the housing  60 . 
         [0085]    Once the locking member  40  has snap fit into place with the housing  60 , the locking member  40  can no longer move in the second longitudinal direction X 2 . The catheter  70  continues to advance out of the package  20  and into the urethra of the user. As the catheter  70  is advanced if it encounters resistance advancing in the first longitudinal direction X 1 , the one-way valve  50  in the locking member  40  grabs the catheter  70  and prevents it from moving in the second longitudinal direction X 2 . 
         [0086]    In the embodiment of the invention shown in  FIGS. 10-13 , engagement members  63  and  64  extend in the second longitudinal direction X 2  from the housing  60 . One end  42   1  of the locking member  40  is pivotally attached via a hinge  46 , such as a live hinge, to the distal end of one of the engagement members  63  for pivoting as between a first dispensing position, depicted in  FIG. 14  and a second locking position depicted in  FIG. 13 . In the first position, achieved by movement of a catheter  70  passing through the valve orifice  51  towards the housing  60 , the other end  422  of the locking member  40  contacts the distal end of the other engagement member  64  whereby the central axis  51   CA  of the valve orifice  51  aligns with the central axis  62   CA  of the pathway  62  through the housing  60 . In this configuration the catheter  70  can translate through the valve orifice  54  and can therefore be dispensed out of the packaging  20 . In the second position, achieved by movement of a catheter  70  passing through the valve orifice  51  away from the housing  60 , the other end  42   2  of the locking member  40  is pivoted away from the distal end of the other engagement member  64  whereby the central axis  51   CA  of the valve orifice  51  is misaligned with the central axis  62   CA  of the pathway  62  through the housing  60 . In this configuration the catheter  70  cannot translate through the valve orifice  51  thereby preventing reinsertion of catheter  70  back into the packaging  20 . 
         [0087]    In all of the embodiments, the locking member  40  prevents the funnel end  72  of the catheter  70  from advancing out of the package  20 . This allows the package  20  to be used as a drainage vessel or an extended drainage tube if the second longitudinal end  24  of the package  20  was removed. It also allows the user to manipulate the catheter  70  without touching the catheter  70 . This helps to prevent contamination of the catheter  70  and reduces the mess to the hands of the user.