Abstract:
A urine collection and drainage device and system adapted to facilitate drainage for patients to that prefer to stay standing during drainage and avoid removal of clothing near the collection bag. A collection vessel is designed to be secured to a user&#39;s waist and leg and allows for quick drainage with low initial compression. Drainage can also be accomplished for handicapped patients that have challenges getting out of bed or a wheelchair.

Description:
CLAIM OF PRIORITY TO INTERNATIONAL APPLICATION 
       [0001]    This application is a continuation in part of U.S. application Ser. No. 14/929,625, filed on Nov. 2, 2015, which is a continuation in part of International Application PCT/US2014/036315, with an international filing date of May 1, 2014, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/818,627, filed May 2, 2013 entitled “A CATHETER COLLECTION AND DRAINAGE DEVICE AND SYSTEM”, wherein said patent applications are incorporated herein by reference in their entireties. 
     
    
     FIELD AND BACKGROUND OF THE INVENTION 
       [0002]    The invention relates generally to a device and system for bodily waste collection and drainage. 
         [0003]    Currently, patients dealing with urinary incontinence and that are catheter users tend to fall into one the following categories: 1) patients that use self-intermittent catheters where no urine collection or drainage bags are necessary; 2) patients with indwelling or Foley catheters who rely on some type of drainage/urine collection bag; and 3) male patients who wear an external or condom catheter (or sheath catheter) that also require a urine drainage bag or collection system. Patients, male or female, that have to rely on some form of collection or drainage bag are faced with a number of challenges such as portability of such a collection bag without creating wardrobe issues and ease of drainage of the collection bag, especially in public restrooms, just to name a few. 
         [0004]    The storage or collection bags currently provided usually attach to the body, customarily to the leg or thigh, by one or two straps, and is connected to either the indwelling catheter or the sheath/condom catheter (or catheter tip) portion by a plastic tube. One challenge is that, as urine collects in the storage bag, its increased weight sometimes causes the connections to disengage or the condom/internal catheter to be pulled loose from the male penis or from the female&#39;s urethra. Another challenge is that there are various sources of potential leakage, i.e., at any of the connection points between the collection bag and an interconnection tube between the bag and the indwelling catheter or seal leaks in the collection bag due to a pressure spike. The result being frequent spillage, leaking, soiling, and embarrassment to the user. Another challenge is that this ungainly arrangement is a barrier to many normal activities, such as running, aerobics, and light physical work. 
         [0005]    Further problems relate to the emptying of the bag of urine, as well with the attachment of the storage bag to the leg or thigh. Either the user has to undress in order to empty the bag, or he has to wear trousers loosely-fitting enough to allow a user to roll up the trouser leg to get at it. Both methods are cumbersome and require the user to take much longer to use a toilet or urinal than is normal. Moreover, if a man has to drain the storage bag in a public urinal, he is faced with an embarrassing situation. Another disadvantage is that there is insufficient support for the storage or collection bag beyond the straps fitted around the leg, which are both tight and uncomfortable yet insecure (i.e., the straps tended to restrict blood circulation yet could not always prevent the storage unit from slipping down the leg). Also, the storage bag prevents the user from wearing ordinary, closely-fitted street clothes, because the collection bag outline could show through and because the trouser leg could not be rolled up high enough to allow the user to access the bag. The drain valve on these storage bags also presents problems, whether the pull-out plug or the screw-off cap. Men with shaky or arthritic hands or with neurologic pathologies (MS, Parkinson&#39;s disease, stroke, etc.) might have difficulty replacing a plug or screwing a cap off and on. Some users also tended to get urine on their hands while draining the device. 
         [0006]    Further, the disabled have particular difficulty in handling such collection bags. The problems of the various types of drainage catheters are so great that some patients are unable to cope with them. Hence, in these instances the only alternative is to wear bulky and embarrassing adult diapers or to refuse to go out in public at all. For all these reasons, the urine-incontinent man or woman is often severely handicapped in both his economic and social life. 
         [0007]    In one prior art device, Cawood discloses in U.S. Pat. No. 4,449,971 an abdominally located urine collection bag that is connected to a catheter protruding up from the patient&#39;s urethra (in this case, the patient&#39;s penis), such that the patient&#39;s urine needs to travel upwards against gravity to be deposited in the abdominally located collection bag. As taught therein, this collection bag system depends on the patient&#39;s bladder detrusor muscle tone and intraperitoneal pressures exerted upon the bladder of the catheterized ambulatory patient so as to cause urine to flow from the bladder to a level as high as 10 centimeters or more above the distal tip of the catheter within the patient. The collection bag is carried by a waistband or belt and is worn over the patient&#39;s abdomen and the bag disclosed in the Cawood patent has a short valve-equipped drain tube that extends downwardly from the bag when the contents are to be drained and that may be folded upwardly and inserted into a pocket provided by the bag when the drain tube is not in use. A challenge with the Cawood system is that not all patients have sufficient bladder strength to force their urine up against gravity to an abdominally located collection bag (especially if a patient has a neurogenic bladder, which provides minimal to no bladder contractions). Further, this collection bag will require more loose fitting clothes to accommodate the device and can create leakage issues if the user has to bend over at the waist just to pick something up. 
         [0008]    Cawood in U.S. Pat. No. 6,471,680 also discloses an abdominally-worn collection bag that includes a long coiled extension tube connected to the drain tube and drain tube connector to allow the patient to drain the urine contents directly into a toilet bowl as shown in the &#39;680 patent. The extension tube has the challenge of having to be uncoiled and then re-coiled and strapped into the front face of this collection bag when trying to empty the urine bag. This requires manual dexterity in managing the tube, partially undressing to manage the long tube and some hygienic challenges in cleaning the tube after each use and ensuring that it is completely empty before recoiling. 
         [0009]    Therefore, there is a need for a urine or body waste collection and drainage device and system that is simple to use and facilitates ease of drainage for the mobile and active patient without all of the complexities of the aforementioned prior art devices. 
       SUMMARY OF THE INVENTION 
       [0010]    Various embodiments of a bodily waste collection and drainage device and system described herein provide advantages over the prior art such as ease of use, ease of drainage or disposal of contents, accommodates to the user&#39;s body and clothing, and longer use due to robust support system. It would further be advantageous to have a collection and drainage device for both men and women that is easy to use and more sanitary then current options available on the market. 
         [0011]    In one example embodiment, a bodily waste collection and drainage system is comprised of a collection bag, a support band or strap adapted to support the bag on the user, an inlet configured to be coupled to a catheter of a user and an outlet having a drainage tube member passing there through for ease of drainage or emptying of the collection bag. The drainage tube member includes a valve for turning on or off the outflow of bodily waste from the collection bag. In a related embodiment, the collection system is configurable for use in colostomy applications or for other drainage applications for the human body. 
         [0012]    In another example embodiment, a catheter device accessory assembly for urine collection of a patient is provided that includes a urine collection vessel having an upper portion and a lower portion and an inlet port disposed on the urine collection vessel and configured to be coupled to a connector, the connector adapted to be connected to a catheter device. The device accessory also includes an outlet port disposed on the upper portion of the urine collection vessel and disposed separate and above the inlet port, the outlet port having an external side and an internal side. The device accessory also includes a drainage tube assembly comprising an external tube portion and an internal tube portion, the external tube portion coupled to the external side of the outlet port and adapted to extend away from the collection vessel for drainage, the internal tube portion coupled to the internal side of the outlet port and adapted to extend from the outlet port and internally into the lower portion of the collection vessel, a distal end of the internal tube portion in operative contact with a floor or bottom of the collection vessel, wherein the internal tube has at least one hole in a sidewall of the tube spaced from the distal end of the internal tube portion. In addition, the collection vessel is configured to be emptied through said drainage tube assembly upon initial compression by the patient of the lower portion of the collection vessel, thereby commencing a siphoning action. In a related embodiment, the urine collection vessel is adapted to be emptied through the drainage tube and with compression by the patient when in a standing position. In yet another related embodiment, a waistband attachment assembly is included which is adapted to support the collection vessel on a user&#39;s body such that the inlet port is adjacent a proximal end of a catheter located in a patient&#39;s urethra. The device accessory further includes a leg band member configured to secure the collection vessel to a patient&#39;s leg and includes a spacing gap member located between the waistband assembly and the upper portion of the collection vessel, the spacing gap configured to house the non-extended external tube portion. 
         [0013]    In yet another example embodiment, a catheter accessory device for collecting urine from a patient includes a urine collection vessel having an upper and lower portions and configured to be supported by the patient&#39;s waist or leg and an inlet port coupled to the urine collection vessel the inlet port having a connector coupled to a catheter. The accessory device also includes an outlet port disposed in the upper portion of and coupled to the urine collection vessel, the outlet port coupled to a drainage tube member that is adapted to extend above the inlet port and away from the collection vessel, an internal portion of the drainage tube member extending to a bottom of the urine collection vessel and an external portion of the drainage tube member comprising a valve for selectively draining the urine collection vessel. The accessory device also includes a drain valve coupled to the bottom of the urine collection vessel and coupled at another end with the internal portion of the drainage tube member, the internal portion of the drainage tube being disposed in an upright configuration from the drain valve and including at least one hole in a sidewall near the drain valve. The urine collection vessel is also adapted to be emptied through the drainage tube member when the patient is in a standing position by initially compressing the vessel until a siphoning action commences. 
         [0014]    In yet another related embodiment, a front panel of the collection vessel of the catheter device assembly is configured to be compressed against a stiffened rear panel of the collection vessel to improve collection vessel drainage. In this example embodiment, the stiffened rear panel is either a thicker rear collection vessel or a rigid/semi-rigid backing plate or panel disposed next to the rear panel of the collection vessel. 
         [0015]    In yet another example embodiment, a bodily fluid collection system for use by a patient including a collection vessel configured to have an inlet port and an outlet port, the inlet port disposed proximate to a patient&#39;s drainage orifice when the collection system is in use, wherein drainage from the orifice occurs gravitationally. The system also includes a bodily conduit member configured to be coupled to said inlet port and coupled to the patient&#39;s drainage orifice and a drainage conduit member configured to be coupled to the outlet port and adapted to extend from the collection vessel for drainage of the collection vessel, wherein a portion of the drainage conduit member extends internally into the collection vessel below the inlet port and wherein a distal end of said drainage conduit member is in operative contact with a floor or bottom of the collection vessel, the drainage conduit member having at least one hole in a sidewall of the tube spaced from the distal end of said drainage conduit member; wherein said collection vessel is configured to be emptied through said drainage conduit member upon initial compression by the patient of the lower portion of the collection vessel, thereby commencing a siphoning action. 
         [0016]    The invention now will be described more fully hereinafter with reference to the accompanying drawings, which are intended to be read in conjunction with both this summary, the detailed description and any preferred and/or particular embodiments specifically discussed or otherwise disclosed. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of illustration only and so that this disclosure will be thorough, complete and will fully convey the full scope of the invention to those skilled in the art. 
     
    
     
       DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0017]      FIG. 1  is a view of a prior art urine collection and drainage device. 
           [0018]      FIG. 2A  is a view of an example embodiment of a urine or bodily waste collection system according to the teachings herein. 
           [0019]      FIG. 2B  is a view of an example embodiment of a bodily waste collection and drainage system in use by a male patient according to teachings herein. 
           [0020]      FIG. 2C  is another example embodiment of a bodily waste collection and drainage assembly according to the teachings herein. 
           [0021]      FIGS. 3A-3B  are views of a waistband accessory for a bodily waste collection device as taught herein. 
           [0022]      FIG. 4  illustrates a side view of a waste collection bag as taught herein. 
           [0023]      FIG. 5  illustrates a front view of another waste collection bag as taught herein. 
           [0024]      FIGS. 6A and 6B  illustrate front and side views of another bodily waste collection assembly as taught herein; and 
           [0025]      FIG. 7  illustrates a front view of yet another bodily waste collection assembly as taught herein. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    Following below are more detailed descriptions of various embodiments of the invention described herein. In particular, the various embodiments disclosed herein describe a urine collection and drainage device for patients that prefer to drain their urine collection bag while in a standing position. It should be appreciated that various aspects of the subject matter introduced above and discussed in greater detail below may be implemented in any of numerous ways, as the subject matter is not limited to any particular manner of implementation. Examples of specific implementations and applications are provided primarily for illustrative purposes. 
         [0027]    Referring to  FIG. 1 , there is a shown a prior art urine collection and drainage device  20  on a patient&#39;s leg  10 . Device  20  includes a collection bag  21 , an inlet  22 , a drain outlet  24  and a pair of straps, upper  26  and lower strap  28 . A catheter (not shown) would normally be inserted into the patient&#39;s bladder through the urethra, which is then coupled to inlet  22 . One disadvantage of this device is that collection bag  21  needs to be emptied from the lower drain outlet  24  requiring the patient to disrobe or pull his pants down in order to reach and activate drain outlet  24 . This is more of a challenge if the patient is in a wheelchair or uses a cane or walker. 
         [0028]    Referring now to  FIGS. 2A-2C , there are described various embodiments of a bodily waste collection and drainage system and device that facilitates emptying or drainage from a standing position of a user or patient. Even if the patient is in a wheelchair or confined to a bed, the bodily waste collection system described herein still allows a patient to conveniently empty the collection bag into a bedpan or it can be used to collect urine samples conveniently from the patient. 
         [0029]    Referring particularly to  FIGS. 2A and 2B , there are shown views of an example embodiment of a bodily waste collection and drainage system  200  for use by a male patient  100  (detached and attached) according to teachings herein. In a related embodiment, system  200  is configured for use for with a female patient and the embedded catheter is configured for connection with the collection bag (such as in  FIG. 2C ). In this example embodiment, system  200  includes a collection bag  210 , an inlet  222 , an outlet  224  and a bottom drain  226 . Inlet  222  is coupled to a connector  223  which is coupled to a catheter  230  that is inserted into a patient&#39;s urethra (genital area  112 ) for drainage of urine collected by bag  210 . A urine (or other bodily fluid) exit tube  225 , having a tip valve  225 A, is coupled to outlet  224  for draining or emptying bag  210  through an upper portion of bag  210 . Tube  225  has a customizable length with an interior diameter (ID) of about, but not limited to, 0.25 inches. In this example embodiment, tube  225  is comprised of an internal portion  225 B (outside bag  210 ) and an external portion  225 C (spanning inside bag  210 ), with the internal portion  225 B having a series of holes  225 D (optional) to facilitate drainage and manage internal pressure. In various embodiments, tube  225  is formed from one or more members. Valve  225 A can be a twist on/off valve, a push button valve, ball valve, a unidirectional valve, a duck bill or any other valve device that allows for drainage of the collection bag with a substantially immediate shut-off. In a related embodiment, the valve is pressure activated and opens when pressure exerted by the patient on the bag (when trying to empty the bag) exceeds the valve&#39;s pressure threshold. In this embodiment, the valve&#39;s pressure threshold is configured to be high enough to avoid leakage if incidental or inadvertent pressure is placed on the collection bag. 
         [0030]    In this example embodiment, exit tube  225  spans a longitudinal length of bag  210  towards the bottom of the bag to assist in the emptying or draining of the bag. Once the user pulls or extends exit tube  225  and points it towards the toilet (or the urinal if standing up or the bedpan if the patient is in bed or in a wheelchair) and actuates valve  225 A, pressure is applied to the bag by the user and then urine or bodily waste is dispelled through tube  225 . Waste collection assembly  200  optionally includes a waistband or holster accessory  240  for supporting bag  210  (at loop or holes  212  and  214 ) and optionally at least one leg strap  250  for strapping bag  210  to a patient&#39;s leg. In this example embodiment, bag  210  is formed in a triangular shape to accommodate the user&#39;s leg and body contour. 
         [0031]    Note that a proximal end of catheter  230  (coming out of patient&#39;s urethra) is disposed level to or substantially level to inlet  222  and connector  223  such that a natural drainage level (taking advantage of gravity) is used for the patient&#39;s convenience, hence not requiring excessive bladder muscles to push the urine out. Another advantage to this design is that the patient controls the drainage and the emptying of the collection bag versus being forced to empty the entire contents all at once with other prior art devices. The ability to control emptying of the collection bag is useful when circumstances may not permit the patient to empty the entire contents all at once. Another advantage to collection system  200  is that it has two bodily waste exits (tube  225  and drain  226 ) as compared to prior art systems that just have one exit, just in case one collection bag drainage option fails. 
         [0032]    Yet another advantage of the collection bag systems disclosed herein is that collection bag  210  is configured to be positioned along the side of one leg near the waist to be more conducive to the contour of the patient&#39;s body and urethral drainage into the bag. In a related embodiment, collection bag  210  is configured to be located in the inside of the patient&#39;s leg to help with concealment, such as when a female patient decides to wear a skirt or a male patient prefers to have the collection bags (with associated connectors/connections) on the inside portion of one leg. In yet another embodiment, system  200  is configurable to have two collection bags on both legs for longer use when traveling or when it is not convenient to empty for a number of hours. 
         [0033]    Referring now to  FIG. 2C , there is shown another example embodiment of a bodily waste collection and drainage assembly  200 A according to the teachings herein. System  200 A includes a standard rectangular collection bag  210 A, with an inlet  222 A, an outlet  224 A located at the medial aspect of the bag and a bottom drain  226 A. Inlet  222 A is coupled to a connector  223 A which is coupled to a catheter  230  that is inserted into a patient&#39;s urethra for drainage of urine collected by bag  210 A. An exit tube  225 A, having a tip valve  225 B, is coupled to outlet  224 A for draining or emptying bag  210 A through an upper portion of bag  210 A. Once the user pulls or extends exit tube  225 A and points it towards the toilet (or the urinal if also using it in a standing position) and actuates valve  225 A, mild pressure or compression is applied to bag  210 A and then urine or waste is dispelled through tube  225 A. Once the bag is emptied to the patient&#39;s satisfaction, valve  225 A is closed and tube  225 A is returned to inside the patient&#39;s clothing. In a related embodiment, system  200  or  200 A or  600  are configurable to include a clip or holder to hold tube  225  securely to bag  210  after use. 
         [0034]    In a related embodiment, the collection bag is configured to have an exit tube comprised of an internal portion member that resides inside bag  210  and an external portion member that extends away from the collection bag and is used by the patient for regular bag drainage. Advantages to this embodiment include hygiene within the bag is maintained as the internal portion member of the exit tube stays within the bag while the external portion may be changed by the patient for any reason. In a related embodiment, the internal portion member is permanently coupled to an outlet port connector that in turn is coupled to an interchangeable external portion tube member. 
         [0035]    In a yet another example embodiment, bag  210  is configured to have an inlet port and outlet port on the same side of bag or vessel  210  to facilitate flexibility in locating vessel  210  proximate to a patient&#39;s bodily fluid drainage orifice (such as a patient&#39;s urethra; or abdomen for abdominal drainage or near buttocks for fecal drainage). In this example embodiment, the outlet port is connected to an exit tube member that is extendible through a patient&#39;s clothing (pants, shirt, skirt, etc.) thereby facilitating easy drainage without completely disrobing. 
         [0036]    In a related embodiment, the collection bag is configurable to only include the upper exit tube without the need for the lower drain tube or drain outlet. This is especially useful where the patient needs a urine collection system with a smaller form factor or wishes to dispose of the unit after it is full. System  200  is configurable for other uses such as a colostomy bag that can be emptied if necessary or used in connection with other drain tubes for bodily fluids wherein the fluid drips or drains out with or without gravitational forces. 
         [0037]    Referring now to  FIGS. 3A-3B , there is a view of a waistband member or assembly  240  for a collection device as taught herein. In particular, member  240  includes a band  242  that includes a fastener assembly  244  at both ends. Fastener assembly  244  includes, but is not limited to, a hook and loop (Velcro®) arrangement, a snap button, and a button and button hole. Waistband member  240  includes connection members  246  for supporting bags  210 ,  210 A,  410 ,  510 , and  610 . 
         [0038]    In a related embodiment, the collection bag is supported in the pelvic area (near the urethra) by providing a spandex-type leg cuff, sleeve or band member (which can also be in the form of a band with a hook and loop or simply a hook fastener, depending on the band material chosen, that is wrapped around the appendage) that is pulled up to the thigh and that has an additional external pocket/sleeve that allows the patient to slip the collection bag down into it. The spandex cuff or sleeve or band member (or other elastic-type material) can have a side slit to accommodate the Foley connection (from the catheter in urethra) and a lower slit to accommodate the bottom drain. In an alternative embodiment, the sleeve (or cuff or band) is on the inside of the leg so that it is between the legs instead of on the side of the leg. The side sleeve/pocket can also be large enough to accommodate a plate member (plastic or other rigid/semi-rigid) that serves as a back plate to the bag to allow the user to press the collection bag or vessel against it for additional leverage. Another advantage to this feature is that in instances where patients have difficulty applying pressure to the bag, the sleeve or cuff or band member can act as the source for producing back pressure within the collection bag as it fills with urine. The level of back pressure, which would be advantageous for bag drainage, can be determined by the denier and compliance of the sleeve or cuff. 
         [0039]    Referring now to  FIG. 4 , there is shown a side view of an example urine collection bag assembly  400  according to the teachings herein. Bag assembly  400  includes a bag portion  410 , with a belt loop assembly  440 , and a backing plate  416 . Belt loop assembly  440  includes a belt loop member  442  and a rear loop support  443 , both of which support bag  410  near the lower pelvic (or genital) area of a patient. Backing plate  416 , in this example embodiment, is either rigid or semi-rigid to provide a surface against a backside  413  of bag  410  to assist the user (during compression) in emptying or draining the bag, as pressing the bag only against the user&#39;s leg during draining may be inefficient or time consuming. In one example embodiment, a waistband assembly used to support bag  410  near the patient&#39;s lower pelvic area is equipped with backing plate  416 . In a related embodiment, bag  410  includes a thicker layer of polyolefin (or PTFE or ePTFE), polyethelyene, polypropylene material or the like to assist in compression of bag  410  by the patient. In yet another related embodiment, backing plate  416  is substituted with a spun polymer sheet fabric or felt-like surface to promote airflow between the leg skin and collection bag  410 . In various embodiments, bag  410  has a volume of about 400 ml-800 ml and a configuration that is tapered in the direction away from belt loop assembly  440 . 
         [0040]    Referring now to  FIG. 5 , there is shown a front view of another example collection assembly  500  which includes a bag portion  510 , with a portion of a belt holding assembly  540  (and retaining buttons  541 ) and a lower retaining leg strap  542 . Similar to collection assembly  200 , assembly  500  includes an inlet  522  with associated connector  523  to connect to a Foley catheter, an outlet  524  with a catheter  525  located there through. Catheter  525  is comprised of an internal portion  525 B (with optional holes  525 D), an external portion  525 C and an end portion/cap with a valve  525 A. In this example embodiment, inlet  522  is equipped with a unidirectional flow valve (or duck valve) in the rear (or inside of bag) to prevent bodily waste or urine from flowing retrograde back towards the patient&#39;s catheter and thus the patient&#39;s bladder. 
         [0041]    Referring now to  FIGS. 6A and 6B , there are shown front and side views of another example embodiment of a bodily waste collection and drainage system  600  for use by a male patient according to teachings herein. In a related embodiment, system  600  is configurable for use by a female patient and the embedded catheter is configured for connection with the collection bag. In this example embodiment, system  600  includes a collection bag  610 , a belt loop assembly portion  640  with a spacer member  650 , which provides some distance between collection bag  610  and loop assembly  640 , thereby allowing bag  610  to be suspended near the patient&#39;s lower pelvic area (close to a urethral catheter). In this example embodiment, seal lines are formed between various sections to strengthen the assembly while creating some space for hygiene for the patient. For example, a seal line  641  is located between belt loop assembly  640  and spacer member  650 . A seal line  651  is located between spacer member  650  and bag  610 . A side view of assembly  600  ( FIG. 6B ) is lined up with the front view and shows loop  640 , spacer member  650 , a front  611  of bag  610  and a rear  613  of bag  610 . 
         [0042]    In this example embodiment, bag  610  includes an ePTFE (or other such material which acts as a one way vent) vent  615 , an inlet  622 ; an outlet  624  and a bottom drain  626  with a cleanout valve. Inlet  622  is coupled to a connector  623  which is coupled to a catheter  630  (not shown) that is inserted into a patient&#39;s urethra for drainage of urine collected by bag  610 . A urine (or other bodily fluid) exit tube  625 , having a tip valve  625 A, is coupled to outlet  624  for draining or emptying bag  610  through an upper portion of bag  610 . In this embodiment, catheter  625  is comprised of an internal portion  625 B (with optional holes  625 D), an external portion  625 C, an outer diameter tube  625 E, and an end portion/cap with a valve  625 A. Valve  625 A can be a twist on/off valve; a push button valve; ball valve, unidirectional valve, duck bill valve or any other valve device that allows for drainage of the collection bag with a substantially immediate shut-off. In a related embodiment, the valve is pressure activated and opens when pressure exerted by the patient on the bag (when trying to empty the bag) exceeds the valve&#39;s pressure threshold. In this embodiment, the valve&#39;s pressure threshold is configured to be high enough to avoid incidental or inadvertent outflow due to pressure placed on the collection bag. 
         [0043]    In this example embodiment, exit tube  625  spans a longitudinal length  625 B of bag  610  towards the bottom of the bag to assist in the emptying or draining of the bag. Once the user pulls or extends exit tube  625  and points it towards the toilet (or the urinal if also standing up or the bedpan if the patient is in bed or in a wheelchair) and actuates valve  625 A, pressure is applied to the bag by the user and then urine or bodily waste is dispelled through tube  625 . Waste collection assembly  600  optionally includes a waistband or holster accessory that couples to belt loop assembly  640  for supporting bag  610  and at least one leg strap  650  for strapping bag  610  to a patient&#39;s leg. In this example embodiment, bag  610  is formed in a triangular or upside flask shape to accommodate the user&#39;s leg and body contour. 
         [0044]    In use, the patient&#39;s indwelling catheter is disposed level or substantially level to inlet  622  and connector  623  such that natural drainage (e.g., gravity) is used for the patient&#39;s convenience, hence not requiring excessive bladder muscles to push the urine out (or up to a bag as in the prior art). Another advantage to this design is that the patient controls the drainage and the emptying of the collection bag versus being forced to empty the entire contents all at once with other prior art devices. The ability to control emptying of the collection bag is useful when circumstances may not permit the patient the empty the entire contents all at once. Other advantages to this collection system are similar to that described above. Collection bag  610  also includes a set of pleats (baffles)  618  to facilitate drainage. Catheter tube device  625 , in various example embodiments is customizable in length, is formed from various materials including a corrugated or ribbed material and has an internal diameter (ID) large enough (for example 0.25 inches) to facilitate drainage and keep internal pressure to a minimum. 
         [0045]    An example of the components and materials used in the various collection systems describe herein include: 
         [0000]    
       
         
               
               
               
             
           
               
                   
                   
               
               
                   
                 Mfgr. And PN 
                 Description 
               
               
                   
                   
               
             
             
               
                   
                 Qosina: 80041 p.172 
                 Tube End Drain Valve, Bag 
               
               
                   
                   
                 Cleanout and Drain Line 
               
               
                   
                 Qosina: 94617 p.167 
                 Urinary Connector, 1-way, 
               
               
                   
                   
                 Foley Connection 
               
               
                   
                 Qosina: DEPH Free PVC 
                 Bag Drain Tube ¼″ × ⅜″ 
               
               
                   
                 Class IV 
               
               
                   
                 Qosina: DEPH Free PVC 
                 Bag Clean Out Tube 0.280″ × 
               
               
                   
                 Class IV 
                 0.400′ 
               
               
                   
                   
                 Elastic Waist Band w/Velcro 
               
               
                   
                   
                 tab, 1.5″ × 30″ 
               
               
                   
                   
                 Elastic Leg Strap w/Velcro 
               
               
                   
                   
                 tab, 1.0″ × 30″ 
               
               
                   
                 Bag, Back, 8 mil Polyolefin 
                 Thicker bag backing 
               
               
                   
                 sheet 
               
               
                   
                 Bag Front, 3 mil Polyolefin 
                 Thinner bag face 
               
               
                   
                 sheet, 
               
               
                   
                 Leg Strap tab, 8 mil 
                 Heat bonded to receive 
               
               
                   
                 polyolefin sheet 
                 waistband 
               
               
                   
                   
               
             
          
         
       
     
         [0046]    The various collection bags described herein are made from any one of, or a combination of, materials: PTFE, expanded PTFE, and PTFE composites, which provide airflow and liquid resistance for vented containers. When integrated into a package design, ePTFE allows for the inflow of gases such as air without allowing liquid to penetrate the venting membrane and subsequently permeate out of the collection bag as internal pressure builds. When liquid penetrates other porous material, airflow stops. This phenomenon is referred to as “wetting out”. Ordinary membranes that simply allow initial airflow will clog quickly, prohibiting consistent airflow and will often leak—especially when a container is in an upside down position during use. Packaging vents, such as vent  615 , allow consistent airflow, even after liquid contact. When liquids are sprayed or dispensed, a vacuum is created within a closed system. These packaging vents allow the package to breathe by equalizing pressure. This simple closure vent solution helps to assure that containers maintain their shape and do not leak while liquids are being dispensed. 
         [0047]    Referring now to  FIG. 7 , there is shown a front view of yet another example embodiment of a bodily waste collection and drainage system  700  for use by a male patient according to teachings herein. In a related embodiment, system  700  is configurable for use by a female patient and an embedded catheter is configured for connection with the collection bag. In this example embodiment, system  700  includes a collection bag  710 , a belt loop assembly portion  740  with a fastener  742  with a spacer member  750 , which provides some distance between collection bag  710  and loop assembly  740 , thereby allowing bag  710  to be suspended near the patient&#39;s lower pelvic area (close to a urethral catheter). In this example embodiment, seal lines are formed between various sections to strengthen the assembly while creating some space for hygiene for the patient. For example, a seal line  741  is located between belt loop assembly  740  and spacer member  750 , while another seal line  751  is located between spacer member  750  and bag  710 . 
         [0048]    In this example embodiment, bag  710  includes (optionally an ePTFE vent or other such material which acts as a one way vent) an inlet  722  and a duck bill or unidirectional flow valve  722 A; an outlet  724 , outlet weld  724 A and a connector  724 B; and a bottom drain joint  726 A with a cleanout valve  726 . Inlet  722  (which may also have a weld connected to the side of the bag for stability) is coupled to a connector  723  which is coupled to a catheter  730  (not shown) that is inserted into a patient&#39;s urethra for drainage of urine collected by bag  710 . A urine (or other bodily fluid) exit tube  725 , having a tip valve  725 A, is coupled to outlet  724  for draining or emptying bag  710  through an upper portion of bag  710 . In this embodiment, catheter  725  is comprised of an internal portion  725 B (with optional one or two infeed holes  725 D), an external portion  725 C, an outer diameter tube  725 E, and an end portion/cap with a valve  725 A. Valve  725 A can be a twist on/off valve; a push button valve; ball valve, unidirectional valve, duck bill valve or any other valve device that allows for drainage of the collection bag with a substantially immediate shut-off. In a related embodiment, the valve is pressure activated and opens when pressure exerted by the patient on the bag (when trying to empty the bag) exceeds the valve&#39;s pressure threshold. In this embodiment, the valve&#39;s pressure threshold is configured to be high enough to avoid incidental or inadvertent outflow due to pressure placed on the collection bag. 
         [0049]    An example of the components and materials used in the various collection systems describe herein include: 
         [0000]    
       
         
               
               
               
             
           
               
                   
                   
               
               
                   
                 Description 
                 Material 
               
               
                   
                   
               
             
             
               
                   
                 State Narrow Fabric Strap- 
                 White Plush Latex Free 
               
               
                   
                 Waist (Skin Contact) 
               
               
                   
                 State Narrow Fabric Strap- 
                 White Plush Latex Free 
               
               
                   
                 Leg (Skin Contact) 
               
               
                   
                 Velcro PSA Hook 
                 Velcro, Nylon with RF Adhesive 
               
               
                   
                 Leg Strap w/ 1.5 × 0.375″ Slit 
                 PVC, (DEHP Free) 
               
               
                   
                 Input Port (Tube) for Mandrel 
                 PVC tube (DEHP Free) 
               
               
                   
                 (Urine Contact) 
               
               
                   
                 Duckbill Valve (Urine 
                 PVC valve, Seal on Edge 
               
               
                   
                 Contact) 
               
               
                   
                 Input Connector 
                 Urinary Connector PC 
               
               
                   
                 Output Port (Tube) for 
                 PVC Tube (DEHP Free) 
               
               
                   
                 Top/Bottom Mandrel w/ ¼″ 
               
               
                   
                 Drain Holes 
               
               
                   
                 Output Port (Tube) for 
                 PVC Tube (DEHP Free) 
               
               
                   
                 Cushion 
               
               
                   
                 Output Port Connector for 
                 HDPE Tube 
               
               
                   
                 Tube 
               
               
                   
                 Drainage Valve 
                 PVC Tube End Drain Valve, 
               
               
                   
                   
                 Twist Control 
               
               
                   
                 Tactile Cushion (Skin 
                 Drain Tube Cushion 
               
               
                   
                 Contact) 
               
               
                   
                 Back Sheet 1 (Skin Contact) 
                 PVC, losy Sontara (DEHP Free) 
               
               
                   
                 Back Sheet 2 
                 PVC (DEHP Free) 
               
               
                   
                 Top Sheet 
                 PVC (DEHP free) 
               
               
                   
                   
               
             
          
         
       
     
         [0050]    In this example embodiment, exit tube  725  spans an almost longitudinal length  725 B of bag  710  towards the bottom of the bag (including an upright section attached to the drain valve with holes  725 D to facilitate siphoning of the fluids) to assist in the emptying or draining of the bag. In this configuration, internal tube  725 B is fixed to the apex or bottom of the vessel on one end and is affixed at the other end the outlet connector, thereby avoiding kinking of the tube or blocking of infeed holes  725 D (holes are about 0.25 inches in diameter). One of the advantages of this configuration is that the urine or bodily fluid pressure builds at the bottom of the vessel as the bag fills and therefore holes  725 D are located at the highest pressure points within the bag. Once the user applies initial compression to empty the bag or vessel, hydraulic pressure will quickly build up within tube  725 B at the bottom so that the fluid flows over the peak curve in the drain tube portion external to the bag and will start emptying the bag automatically and without further compression. In other prior art configurations, the use of Y or T connectors to connect the inlet and outlet to the same internal drain tube or to connect to only one port, by which both the inlet and outlet tubes are connected, although arguably cost effective due to less parts being used in the device, the connectors and shared inlet/exit tubes actually lower the pressure at the bottom of the collection bag making it more difficult for the user to empty the bag contents and to try to initiate the siphoning or emptying action. In other prior art configurations, only using interior tube or the drainage tube and valve at the bottom of the bag (each of which may not be not secure and subject to movement or kinking) makes draining the bag through the upper drainage tube dependent on the interior diameter of the drainage tube opening and the expectation of minimal movement of the unsecured tube end within the bag or collection vessel. 
         [0051]    Once the user pulls or extends exit tube  725  and points it towards the toilet (or the urinal if also standing up or the bedpan if the patient is in bed or in a wheelchair) and actuates valve  725 A, pressure is initially applied to the bag by the user and then urine or bodily waste is expelled through tube  725  once the siphoning action commences (after which the user no longer needs to exert any pressure as the bag empties itself). In this example embodiment, the combination of the upright configuration of the tube near the drain valve along with the infeed holes on the sidewall facilitate the creation of the siphoning action to empty the vessel. Waste collection assembly  700  optionally includes a waistband or holster accessory that couples to belt loop assembly  740  for supporting bag  710  and at least one leg strap  750  for strapping bag  710  to a patient&#39;s leg. In this example embodiment, bag  710  is formed in a triangular or upside flask (or chevron) shape to accommodate the user&#39;s leg and body contour as well as to concentrate the bodily fluid (and pressure) closer to the drain tube and infeed holes  725 D. 
         [0052]    In use, the patient&#39;s indwelling catheter is disposed level or substantially level to inlet  722  and connector  723  such that natural drainage (e.g., gravity) is used for the patient&#39;s convenience, hence not requiring excessive bladder muscles to push the urine out (or up to a waist bag as in the prior art). Another advantage to this design is that the patient controls the drainage and the emptying of the collection bag versus being forced to empty the entire contents all at once with other prior art devices. The ability to control emptying of the collection bag is useful when circumstances may not permit the patient to empty the entire contents all at once. Other advantages to this collection system are similar to that described above. Catheter tube device  725 , in various example embodiments is customizable in length, is formed from various materials and has an internal diameter (ID) large enough (for example 0.25 inches) to facilitate drainage and keep internal pressure to a minimum. Various embodiments described herein are operable with different types of catheters including, but not necessarily limited to, Foley and condom or uri-sheath catheters. 
         [0053]    In another example embodiment, a bodily fluid collection system for a patient is provided that includes a bodily fluid collection vessel having an upper portion and a bottom portion and an inlet port disposed on said fluid collection vessel. The fluid collection system also includes a drain valve coupled to the bottom portion of the fluid collection vessel and is adapted for selectively draining contents of the collection vessel upon actuation of the drain valve. The fluid collection system further includes a waistband attachment assembly adapted to support said fluid collection vessel on a user&#39;s body and on the user&#39;s leg. The waistband attachment assembly is configured to support the collection vessel on the user&#39;s body such that the inlet port is adjacent an end of a catheter located away from a patient&#39;s urethra. The waistband assembly further includes a leg band member configured to secure said collection vessel to a patient&#39;s leg. In related embodiments, waistband attachment assembly includes at least one loop such that a user can pass a waist-belt through the loop to support the collection vessel or includes a waistband with a fastener assembly at least at one end, wherein the fastener assembly includes one of a hook and loop arrangement, a snap button, a button and button hole. 
         [0054]    In a related example embodiment, the inlet port is configured to be connected to a catheter device and the collection system further includes a spacing gap member located between the waistband assembly and the upper portion of the collection vessel, the spacing gap configured to house an optional external tube portion. The collection system further includes a drainage tube assembly coupled to the drain valve and is adapted to extend away from the collection vessel for drainage. In this example embodiment, the drain valve member for selectively draining said fluid collection vessel is selected from the group consisting of a twist on/off valve, a push button valve, a ball valve, a unidirectional valve, and a duck bill valve. 
         [0055]    In yet another related embodiment, the collection vessel is formed in a shape selected from the group consisting of a chevron, an upside down triangle, an ellipse, and a teardrop. The collection vessel is configured to be compressed against a stiff rear or back panel coupled to and protruding down from the waistband attachment assembly, wherein the stiff back panel contacts the user&#39;s leg. In a related embodiment, a front panel of said collection vessel is configured to be compressed against an equally sized stiffened rear panel of said collection vessel to improve collection vessel drainage of contents within said collection vessel. In yet another related embodiment, the collection vessel includes one of a vent on an upper portion of the vessel, an inlet port with a unidirectional flow valve to prevent fluids from flowing out through the inlet port and at least one baffle within the collection vessel adapted for ease of drainage. 
         [0056]    In yet another example embodiment, a catheter device accessory assembly for urine collection of a patient includes a urine collection vessel having an upper portion and a bottom portion and an inlet port disposed on said urine collection vessel and configured to be coupled to a catheter device. The device accessory assembly further includes a drain valve coupled to the bottom portion of the urine collection vessel and is adapted for selectively draining contents of the collection vessel upon actuation of the drain valve. The assembly further includes a leg attachment assembly adapted to support the collection vessel about a user&#39;s leg. In a related embodiment, the leg attachment assembly includes a pocket or pouch to support the collection vessel and the leg attachment assembly is one of an expandable leg cuff, a leg brace and a bandage configured to be wrapped around a user&#39;s leg. 
         [0057]    The following patents and publications are herein incorporated by reference in their entireties: U.S. Pat. Nos. 5,002,541; 5,618,277; 6,007,521; 7,160,276; 7,931,630 and 8,002,766. 
         [0058]    While the various embodiments of the invention have been described above in terms of specific embodiments, it is to be understood that the invention is not limited to these disclosed embodiments. Upon reading the teachings of this disclosure, many modifications and other embodiments of the invention will come to mind of those skilled in the art to which this invention pertains, and which are intended to be and are covered by both this disclosure and the appended claims. It is indeed intended that the scope of the invention should be determined by proper interpretation and construction of the appended claims and their legal equivalents, as understood by those of skill in the art relying upon the disclosure in this specification and the attached drawings.