Patent Publication Number: US-2023138034-A1

Title: Drain asembly for elimination of urine waste from an ostomy bag

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to provisional patent application U.S. Ser. No. 63/273,238, entitled “BOBTAIL TUBE EXTENSION WITH VALVES FOR ELIMINATION OF URINE WASTE FROM AN OSTOMY BAG” filed Oct. 29, 2021, the disclosure of which is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present disclosure is generally directed to medical devices. In particular, the present disclosure is directed to drain assemblies and ostomy bag arrangements for elimination of urine waste from an ostomy bag. 
     BACKGROUND OF THE INVENTION 
     Ostomy bags or pouches are used to trap urine draining through a stoma on the stomach wall. Current ostomy bags are drained in various ways. Some bags have a long pin like device to pinch the bottom of the bag closed. Other ostomy bags have valves that are either openings which can be plugged or a valve with turns open or closed. 
     All known ostomy bags provide a cumbersome way to be emptied. The ostomy bag must be pulled out from clothing to be emptied while standing or sitting. This requires that the bag be held by the wearer or caregiver as the pin or plug is removed and/or the valve opened to allow the urine to drain. The bags empty the same way for men or women. Draining the bag is done through an opening at the bottom of the bag which means the opening must be held in while aiming for the disposal location. The current process to empty all ostomy bags is using a very short valve or plug at the bottom of the bag. These valves or plugs only extend for about ½ inch. This manner of draining provides an undesirable lack of accuracy resulting in spillage and mess. 
     What is needed are a drain assembly, ostomy bag arrangement and method for draining urine that is convenient, discreet and more accurate than existing ostomy bags. Other features and advantages will be made apparent from the present specification. The teachings disclosed extend to those embodiments that fall within the scope of the claims, regardless of whether they accomplish one or more of the aforementioned needs. 
     SUMMARY OF THE INVENTION 
     The present disclosure is directed to a drain assembly and ostomy bag arrangement that allows for male and female wearers of ostomy bags to discreetly and more accurately empty bags of urine waste. For example, the ostomy bag arrangement according to the present disclosure allows male wearers to use the device while at a urinal by simply pulling the flexible conduit with the discharge valve out and opening the valve. Likewise, the drain assembly according to the present disclosure allows a woman to stand facing the toilet and draining the ostomy bag. The longer drain assembly helps with handling the various clothing items. The drain assembly also allows a man or woman to easily sit and drain the ostomy bag into the toilet. It affords privacy and accuracy for all users. 
     According to an embodiment of the present disclosure, a drain assembly for use with an ostomy bag is provided. The drain assembly includes a connector configured to attach to the ostomy bag. A flexible conduit extends from the connector. A discharge valve is positioned at a distal end of the flexible conduit from the connector. The flexible conduit is of a sufficient length and sufficient flexibility to permit an ostomy bag wearer to position the discharge valve into a discharge position outside of the ostomy bag wearer’s clothing for discharge of urine waste from the ostomy bag. 
     According to an embodiment of the present disclosure, an ostomy bag arrangement for elimination of waste urine from an ostomy bag is provided. The ostomy bag arrangement includes an ostomy bag for receiving waste urine from an ostomy bag wearer. The ostomy bag arrangement also includes a drain assembly detachably engaged to the ostomy bag. The drain assembly includes a connector configured to attach to the ostomy bag. A flexible conduit extends from the connector. A discharge valve is positioned at a distal end of the flexible conduit from the connector. The flexible conduit is of a sufficient length and sufficient flexibility to permit an ostomy bag wearer to position the discharge valve into a discharge position outside of the ostomy bag wearer’s clothing for discharge of urine waste from the ostomy bag. 
     According to an embodiment of the present disclosure, a kit for assembly of a drain assembly for attachment to an ostomy bag is provided. The kit includes a plurality of flexible conduits, each having a configuration that permits attachment to a connector and a discharge valve at distal ends of the flexible conduit. The connector is configured to attach to the ostomy bag. The discharge valve is configured to permit connection to the flexible conduit at a distal end from the connector. The flexible conduit, when assembled to the connector and the discharge valve, includes sufficient length and sufficient flexibility to permit an ostomy bag wearer to position the discharge valve into a discharge position outside of the ostomy bag wearer’s clothing for discharge of urine waste from the ostomy bag. 
     Other features and advantages of the present invention will be apparent from the following more detailed description of the preferred embodiment, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG.  1    schematically illustrates a drain assembly according to an embodiment of the present disclosure. 
         FIG.  2    schematically illustrates an ostomy bag assembly utilizing a drain assembly according to an embodiment of the present disclosure. 
         FIG.  3    schematically illustrates an ostomy bag wearer having an ostomy bag assembly utilizing a drain assembly according to an embodiment of the present disclosure. 
         FIG.  4    shows the ostomy bag wearer of  FIG.  3    with the drain assembly according to an embodiment of the present disclosure in an alternate position. 
         FIG.  5    shows an ostomy bag wearer of  FIG.  3    directing a portion of the drain assembly according to the present disclosure through the wearer’s clothing. 
         FIG.  6    shows a kit for assembly of a drain assembly for attachment to an ostomy bag according to an embodiment of the present disclosure. 
         FIG.  7    shows a discharge valve for use with a drain assembly according to an embodiment of the present disclosure. 
         FIG.  8    shows an alternate discharge valve for use with a drain assembly according to an embodiment of the present disclosure. 
         FIG.  9    shows an alternate discharge valve for use with a drain assembly according to an embodiment of the present disclosure. 
         FIG.  10    shows an alternate discharge valve for use with a drain assembly according to an embodiment of the present disclosure. 
         FIG.  11    shows an alternate discharge valve for use with a drain assembly according to an embodiment of the present disclosure. 
         FIG.  12    shows an alternate discharge valve for use with a drain assembly according to an embodiment of the present disclosure. 
     
    
    
     Wherever possible, the same reference numbers will be used throughout the drawings to represent the same parts. 
     DETAILED DESCRIPTION OF THE INVENTION 
     Disclosed herein is a new and useful device and system that affords an ostomy bag wearer, such as a person that has had a urostomy, both greater discreet drainage of the urine waste from an ostomy bag and greater control of the flow of the urine waste. For example, the ostomy bag arrangement according to the present disclosure affords the male wearer a sense of normalcy while using a urinal. In addition, the ostomy bag arrangement according to the present disclosure affords peace of mind to both male and female users of ostomy bags that an ostomy bag can be conveniently, accurately, and discreetly emptied either into a urinal, toilet or other suitable waste receptacle. 
     By use of the drain assembly according to the present disclosure, a male can wear an ostomy bag having a drain assembly according to the present disclosure attached thereto and empty the ostomy bag while discreetly standing at a urinal without having to extract the ostomy bag from the wearer’s clothing. Likewise, by use of the drain assembly according to the present disclosure male or female has greater control of the flow and direction of urine emptying a bag while seated on a toilet. An ostomy bag wearer may drain an ostomy bag with a greater control of direction of the emptying flow of urine by directing the end of the drain assembly into a urinal, much like the natural way to void the bladder. Alternatively, the drain assembly may be positioned with the ostomy bag wearer in a seated position with the discharge valve below the toilet seat, which allows males or females to take advantage of the convenient and discreet draining of the ostomy bag. In another embodiment, the ostomy bag may be emptied into any convenient waste receptacle, such as a bottle or other receptacle, for example, when there is no restroom available, with the discharge vale being able to be directed into the waste receptacle. Further objects and advantages of the presently disclosed invention is to allow a way to provide a convenient and discreet way to empty an ostomy bag in public. 
       FIGS.  1  and  2    show a drain assembly  100  (see  FIG.  1   ) for use with an ostomy bag  201  and an ostomy bag arrangement  200  (see  FIG.  2   ) according to an embodiment of the present disclosure. Drain assembly  100  includes a connector  103  configured to attach to the ostomy bag  201 . Connector  103  detachably engages an ostomy bag  201 . Connector  103  may include features, such at hooks, detents, threading, clips, fasteners, or any other connecting features that allow the connector to detachably engage the ostomy bag  201 . In certain embodiments, the connector  103  may be a connector commercially available form the ostomy bag manufacturer for connection to other ostomy bag accessories, such as connections to night bags. A flexible conduit  105  attaches to and extends from the connector  103 . The flexible conduit  105  may be connected to connector  103  as a unitary component or may be attached by a suitable attachment mechanism, such as a hose barb or tapered connector. There are various configurations of connectors  103 . One type of connector  103  connects by snapping onto a port found at the distal end of the drainage valve located at the bottom of an ostomy bag  201  or pouch. Other connectors  103  connect by pushing in the male end of a tapered cone into the drainage tube once the plug is removed. This type is used with bags which have no valve but use a tube with a plug. The drainage plug is pulled out and the cone is inserted. In one embodiment, connectors  103  have a configuration that may be used to connect a long tube, usually 4-6 feet, to drain opening of the ostomy bag  201  or pouch and at the distal end to connector to an overnight drainage collection system (not shown). 
     A discharge valve  107  is positioned at a distal end of the flexible conduit  105  from the connector  103 . Like connector  103 , the flexible conduit  105  may be attached to the discharge valve  107  by a suitable attachment mechanism, such as a hose barb or tapered connector, or the flexible conduit  105  and the discharge valve  107  may be a unitary component. The flexible conduit  105  is of a sufficient length and sufficient flexibility to permit an ostomy bag wearer  301  to position the discharge valve  107  into a discharge position outside of the ostomy bag wearer’s  301  clothing for discharge of urine waste from the ostomy bag  201 . Suitable lengths for the flexible conduit  105  include lengths or about 3 inches to about 8 inches. Alternately, the length of the drain assembly  100 , including the flexible conduit  105 , according to the present disclosure may be from 4 to 8 inches and may depend upon user preference. The length of the flexible conduit  105  is limited such that the length is sufficiently long to allow positioning of the discharge valve  107  into a location that permits drainage into a waste receptacle but is sufficiently short to avoid kinking or storage issues. In addition, if the total length of the drain assembly  100  is very short it is difficult and/or awkward to pull the drain assembly  100  through clothing to drain. If the drain assembly  100  is too short, the drain assembly  100  may slip into the underpants which may result in a requirement of the wearer to need to dig or reach for the drain assembly  100  inside their clothing. The length of the flexible conduit  105  serves to both allow convenient drainage of ostomy bag  201  and to permit the wearer to comfortably wear the ostomy bag arrangement  200 . If the flexible conduit  105  is too long, the discharge valve  107  and the flexible conduit  105  may drop down the leg or lay against the genitals of the wearer. 
     Flexible conduit  105  may be fabricated from any suitable flexible material for contact with urine or other bodily fluids. For example, flexible conduit  105  may be a thermoplastic or fluoroplastic polymer, such as latex-free, vinyl tubing. Suitable materials for the flexible conduit  105  include, but are not limited to, polyethylene (PE), polyurethane (PU), polyvinylchloride (PVC), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP) polyfluoroalkoxy alkane (PFA), polyvinylidene difluoride (PVDF), Polyether ether ketone (PEEK), silicone, nylon, Nalgene, thermoplastic elastomer (TPE) or any other suitable flexible tubing material. In addition to flexural modulus of the material of construction, the flexibility of the flexible conduit  105  is provided by the wall thickness. The diameter and the wall thickness of the flexible conduit  105  is a diameter suitable for draining of waster urine and flexible manipulation of the drain assembly  100 . For example, in one embodiment, the diameter of the flexible conduit  105  may be from about 5 mm to about 15 mm, or from about 7 mm to about 13 mm, or from about 8 mm to about 10 mm or about 9 mm. Likewise, in one embodiment, the wall thickness may be from about 1.0 mm to about 2.0 mm or about 1.25 mm to about 1.75 mm or from about 1.4 mm to about 1.6 mm or about 1.5 mm. The flexibility of the material includes a flexural modulus that is sufficiently high or sufficiently stiff to maintain an open tube that allows flow of liquid, but also is sufficiently low or sufficiently flexible to permit movement and positioning of discharge valve  107 . Further flexible conduit  105  is sufficiently flexible to avoid kinking and cutting off the flow of liquid. In addition, the flexible conduit  105  is sufficiently resilient to spring back to shape after being bent or compressed and/or sufficiently elastic to return to its shape quickly after being stretched or expanded. In addition, the flexible conduit  105  should have a hardness that is resistant to kinking at tight bends. Hardness of the flexible conduit  105  is measured as its durometer, and different scales, namely Shore A, Shore D, and Rockwell R, are commonly used for plastic and rubber materials. The lower the scale number, the softer and more flexible the material will be. For instance, a typical latex tubing hardness rating is Shore A35. Polyurethane tubing is not as soft and can measure between Shore A70 and A95. Harder materials like nylon and polyethylene are normally measured on the Shore D scale, and others (polypropylene, for example) use the Rockwell R scale. Flexibility may also be a function of hardness or durometer and wall thickness. In addition, the overall length of the flexible conduit  105  may also affect the flexibility. For example, a 6 inch long flexible conduit  105  is more flexible than a 2 ½ inch flexible conduit. Lower durometer numbers are desired for the flexible conduit  105 . 
     In one embodiment, the flexible conduit  105  may be formed from medical tubing commercially available from Thermo Fisher Scientific (Waltham, Massachusetts), Convatec (Reading, Berkshire, England, UK) or Saint Gobain Performance Plastics (La Defense, Courbevoie, France). A removable cap  109  may be optionally positioned on the discharge valve  107  to prevent undesired flow of urine from the discharge valve  107 . Cap  109  may include a tether or similar retention feature to retain the cap  109  near the discharge valve  107  and prevent loss or dropping of the cap  109 , for example in a urinal or toilet. In another embodiment, the flexible conduit  105  is a flexible corrugated tube to make it easier to bend from the bottom of the ostomy bag  201  to the zipper opening without bending or twisting the bag. 
       FIG.  2    shows an ostomy bag arrangement  200  according to an embodiment of the present disclosure. The ostomy bag arrangement  200  includes an ostomy bag  201  that is configured to receive waste urine from a person having a urostomy or other similar medical procedure that results in redirection of urine from the kidneys to a bag or reservoir outside of the body. “Ostomy bag”, as utilized herein refers to bags or pouches utilized to collect urine. The terms ostomy “bag” and “pouch” are utilized interchangeably herein. For example, an ostomy bag wearer  301  may have had a urostomy. A urostomy is a surgery that creates a stoma in the patient’s abdomen. Specifically, the stoma is attached to a place in the urinary tract to let urine leave the body. The majority of urostomies are placed on the right side and can be above the level of the umbilicus or below. At the stoma, the ostomy bag  201  may be attached or otherwise positioned on the wearer to collect urine for disposal. There are a number of configurations of ostomy bags  201 , which are available from a number of different manufacturers. These ostomy bags  201  include an inlet opening  203  on a side of the ostomy bag  201  to receive urine from the stoma and a drain opening  205  at an end of the ostomy bag  201  that permits draining of the waste urine from the ostomy bag  201 . As shown in  FIG.  2   , the ostomy bag  201  may include valve at the drain opening  205  to control the unintended flow of urine from the bag. While  FIG.  2    shows this valve, the valve may be omitted and a cap  109 , pin, pinched connection or other flow restraining features may be included. As shown in  FIG.  2   , a drain cap  207  in addition to the valve may be utilized to prevent the unintentional flow of urine. 
     The drain assembly  100  may attach to any ostomy bag  201 , regardless of configuration or manufacturer, by configuring connector  103  to match the particular ostomy bag  201  discharge. The connector  103  detachably engages with a mating feature  209  of the ostomy bag  201 . The mating feature  209  may include any suitable features, including barbs, tapers, threading, clips, protrusions, or other connecting features that detachable engage connector  103  and prevent leakage of liquid. These features may vary, for example, based upon manufacturer or ostomy bag configuration. For example, ostomy bags  201  are available from various manufacturers including Hollister (Libertyville, Illinois), Convatec (Reading, England, United Kingdom) and Coloplast (Humlebaek, Denmark). Connectors  103  that mate with the mating feature of  209  of these manufacturers may be of different diameters and configurations. The connectors  103 , however, are integral to or connect to flexible conduit  105  of the drain assembly  100  according to an embodiment of the present disclosure. For example, connector  103  may include a hose barb or other connection suitable for connecting to the flexible conduit  105 . The mating feature  209  and the connector  103  are detachable so that the drain assembly  100  may easily be removed from the ostomy bag  201  for either attachment to an ostomy bag accessory, such as a night receptacle, or so that the bag has a lower profile for the wearer for extended wear periods. 
       FIG.  3    shows an ostomy bag wearer  301  having a stoma  303  onto which an ostomy bag  201  is mounted. Ostomy bag  201  is part of an ostomy bag arrangement  201  according to the present disclosure. As shown in  FIG.  2   , the ostomy bag arrangement  200  includes a drain assembly  100  having a connector  103  that is attached to the ostomy bag  201 . The connector  103  is likewise attached to a flexible conduit  105  that extends to a discharge valve  107 .  FIG.  4    includes the ostomy bag arrangement  200  as shown and described in  FIG.  3   , wherein the flexible conduit  105  and discharge valve  107  are in an alternate position. The use of the flexible conduit  105  in the drain assembly  100  allows such positioning. The positioning of the discharge valve  107  and the flexible conduit  105  is not limited to the positioning shown in  FIGS.  3 - 5   , but may include any positioning or storage within the reach provided by the flexible conduit  105 . For example, the discharge valve  107  may be positioned or tucked into a pocket or waistband of the wearer’s clothing  501 . In another embodiment, the flexible conduit  105  allows for the ostomy bag arrangement  200  to be worn with the distal end including the discharge valve  107  at least partially sticking out or through an opening in undergarments, hidden from view by the clothing  501  of the wearer. The flexible positioning of the discharge valve  107  and the flexible conduit  105  permit discreet and convenient storage and positioning of the discharge valve  107  and flexible conduit  105  in the clothing of the ostomy bag wearer  301   
       FIG.  5    shows an embodiment according to the present disclosure wherein the discharge valve  107  has been directed through an opening in the ostomy bag wearer’s clothing  501  to permit drainage of the ostomy bag  201  into an external waste receptacle, such as a urinal or toilet. The positioning of the discharge valve  107  is not limited to the positioning shown in  FIG.  5    and may include positioning over a waistband of the wearer’s clothing  501 , down underneath a wearer’s skirt or shorts or through other openings in the wearer’s clothing  501 . 
       FIG.  6    shows a kit  601  for assembly of a drain assembly  100  for attachment to an ostomy bag  201  according to an embodiment of the present disclosure. The kit  601  includes a plurality of flexible conduits  105  of different lengths, each having a configuration that permits attachment to a connector  103  and a discharge valve  107  at distal ends of the flexible conduit  105 .  FIG.  6    shows three flexible conduits  105 , but the invention is not so limited. Any number of flexible conduits  105 , such as more or less than three, may be provided in kit  601 . For example, in one embodiment, flexible conduit lengths in a kit be categorized into short, medium, long and extra-long, depending on the comfort of the bag wearer  301 . For example, suitable sizes of flexible conduit  105  may be provided in kit  601  to provide drain assembly 100 total lengths of the following: short - 7.62 cm (3 in.), medium -10.16 cm (4 in.), long - 15.24 cm (6 in) and extra-long - 20.32 cm (8 in). In other embodiments, color coding or other indicia or a set of multiple lengths may be provided. The connector  103  is configured to attach to a mating feature  209  of an ostomy bag  201 , which would be provided separately from kit  601 . In another embodiment, kit  601  may include an ostomy bag  201  with a mating feature  209  to detachably engage the connector  103  of the drain assembly  100 . Each of the connector  103  and the discharge valve  107  include connection features, such as hose barbs or tapered connectors to allow assembly of the flexible conduit  105  to each of the connector  103  and the discharge valve  107 . The discharge valve  107  is configured to permit connection to the flexible conduit  105  at a distal end from the connector  103 . Kit  601  may also include a cap  109 . The cap  109  may be positioned on the discharge valve  107  to prevent undesired flow of urine from the discharge valve  107 . Cap  109  may include a tether or similar feature to retain the cap  109  near the discharge valve  107  and prevent loss or dropping of the cap  109 , for example in a urinal or toilet. The flexible conduit  105 , when assembled to the connector  103  and the discharge valve  107 , includes sufficient length and sufficient flexibility to permit an ostomy bag wearer  301  to position the discharge valve  107  into a discharge position outside of the ostomy bag wearer’s clothing  501  for discharge of urine waste from the ostomy bag  201 . The kit  601  may be contained in or includes a sealable container. In another embodiment, kit  601  may include a bag or carrying receptacle, to carry or store the components of the drain assembly  100  or to carry or store an assembly drain assembly  100 . In this embodiment, the bag or carrying receptacle is preferably sealable to contain any odor or residual liquid. 
     To utilize the drain ostomy bag arrangement  200  according to the present disclosure, the wearer of the ostomy bag arrangement  200  positions themselves near a waste receptacle. For example, the wearer stands at a urinal or sits on a toilet. The wearer then directs the discharge valve  107  of the ostomy bag arrangement  200  to a position that allows direct flow of the waste urine from the ostomy bag  201  into the waste receptacle. The positioning of the discharge valve  107  is permitted by the flexible conduit  105 . In another embodiment, particularly relevant for a female wearer, the wearer may stand facing a toilet to direct the discharge valve  107  toward the toilet. In this embodiment it may be desirable to have a longer flexible conduit  105 , including, for example an 8 inch or more flexible conduit. In another embodiment, drain assembly  100  may include a bag or carrying receptacle, to carry or store the assembly drain assembly  100 . In this embodiment, the bag or carrying receptacle is preferably sealable to contain any odor or residual liquid. In this embodiment, the wearer would remove the drain assembly  100  from the bag or carrying receptacle, connect the drain assembly  100  to the ostomy bag  201  and, upon completion of the draining, return the drain assembly  100  to the bag or carrying receptacle. 
       FIGS.  7 - 12    shows various configurations of discharge valves  107  suitable for use with the drain assembly  100  according to the present disclosure. Each of the discharge valves  107  includes a valve actuator  701  to actuate the valve between a closed position to an open position. In addition, discharge valves  107  include a valve body  703  connected to the valve actuator  701 . The valve actuator  701  may be side, top mounted or otherwise mounted in a manner to permit actuation of the valve body  703 . For example, the valve body  703  may include an internal cylinder where the valve actuator  701  actuates the cylinder a quarter turn to actuate the valve from an open position to close position. This actuation positions the bore of the valve body  703  to align itself longitudinally allowing fluid flow. The valve actuator  701  may be moved up, down or side to side or rotated for the quarter turn alignment. While the above has been described as a quarter turn actuation, greater or less than a quarter turn actuation may be used. In addition, the discharge valve  107  includes a discharge end  705  that permits discharge of urine from the drain assembly  100 . The discharge end  705  includes a geometry that permits directing of the flow of waste urine into the desired waste receptacle. In addition, discharge end  705  has a geometry that permits the addition of a cap  109  (see  FIGS.  1  and  2   ) to prevent the undesired flow of urine from the discharge valve  107 . The discharge valve  107  further includes a discharge valve connector  707  that connects to flexible conduit  105  (flexible conduit  105  shown in  FIGS.  7 - 9   ). The discharge valve connector  707  includes a hose barb, taper, protrusion or other feature that allows connection to flexible conduit  105 .  FIGS.  7 - 12    show various configurations of discharge valve connectors  707 . In another embodiment, the discharge valves  107  may include a smooth low profile valve actuator  701  that would minimize edges and overall dimensions. This exemplary configuration provides mitigation against catching on the wearer’s clothing  501 . Other configurations of discharge valve  107  may be utilized with the drain assembly  100  according to the present disclosure. 
     While the exemplary embodiments illustrated in the figures and described herein are presently preferred, it should be understood that these embodiments are offered by way of example only. Accordingly, the present application is not limited to a particular embodiment, but extends to various modifications that nevertheless fall within the scope of the appended claims. The order or sequence of any processes or method steps may be varied or re-sequenced according to alternative embodiments. 
     It is important to note that the construction and arrangement of the various exemplary embodiments is illustrative only. Although only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited in the claims. For example, elements shown as integrally formed may be constructed of multiple parts or elements, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present application. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. In the claims, any means-plus-function clause is intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Other substitutions, modifications, changes and omissions may be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present application.