Patent Document

INDEX TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/753,020 filed on Jan. 16, 2013, the disclosure of which is incorporated herein by reference in its entirety, of U.S. Provisional Patent Application Ser. No. 61/927,078 filed on Jan. 14, 2014, the disclosure of which is also incorporated herein by reference in its entirety, and of U.S. Provisional Patent Application Ser. No. 61/927,916 filed on Jan. 15, 2014, the disclosure of which is also incorporated herein by reference in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The use of a catheter to allow a patient to micturate while undergoing medical treatment or for other reasons is well known. One common catheter of this type is known as a Foley catheter. A Foley catheter is a flexible tube that is passed through the urethra and into the bladder. The tube has two separate channels, or lumens, running down its length. One lumen is open at both ends, and allows urine to drain out into a collection bag. The other lumen has a valve on the outside end and connects to a balloon at the tip; the balloon is inflated with sterile water when it lies inside the bladder, in order to stop it from slipping out. Foley catheters are commonly made from silicone rubber or natural rubber. 
     The name comes from the designer, Dr. F. Foley a surgeon working in Boston Mass. in the 1930s. His original design was adopted by C. R. Bard and Company of Murray Hill, N.J., who manufactured the first prototypes and named them in honor of the surgeon. 
     The relative size of a Foley catheter is described using French Units (F). The most common sizes are 10 French to 28 French. A catheter of 1 French has a diameter of 0.33 mm. 
     Foley catheters come in several sub-types: “Coudé” (French for elbowed) catheters have a 45° bend at the tip to allow easier passage through an enlarged prostrate. “Council tip” catheters have a small hole at the tip which allows them to be passed over a wire. “Three way” or “triple lumen” catheters have a third channel, which is used to infuse sterile saline or another irrigating solution. These are used primarily after surgery on the bladder or prostrate, to wash away blood and blood clots. 
     A major problem with Foley catheters is that they have a tendency to contribute to urinary tract infections (UTI). This occurs because bacteria can travel up the catheters to the bladder where the urine can become infected. To combat this, the industry is moving to antiseptic coated catheters. This has been helpful, but it has not completely solved this major problem. An additional problem is that Foley catheters tend to become coated over time with a bio-film that can obstruct the drainage. This increases the amount of stagnant urine left in the bladder, which further contributes to the problem of urinary tract infections. When a Foley catheter becomes clogged, it must be flushed or replaced. 
     In addition, long term use of such catheters may result in the shrinkage of the bladder, and a loss of muscle tone in the muscles used to control urine flow. In this case when the catheter is removed, incontinence may result. The present invention overcomes these problems and can be employed with any catheter and is not limited to a Foley catheter. These and other problems with catheter usage will be solved by use of the invention described below. 
     BRIEF SUMMARY OF THE INVENTION 
     The invention comprises a urine flow control device which is placed in a urine flow lumen intermediate the bladder and the urine collection bag. The urine flow control device is external to the human body. The urine flow control device comprises an input port which is connected to the urine flow lumen on the top and then into an input housing. The input housing is adapted to hold a magnetic valve assembly which when closed, stops the flow of urine, and when open, allows the urine to flow into a bell or ovoid shaped output housing. The output housing includes an output port which would be connected to the urine flow lumen below the device, which in turn is connected to a urine collection bag. 
     The magnetic valve assembly comprises a housing which holds a stationary magnet and a flap magnet. The lower or flap magnet is for opening and closing the urine flow path. The human body and the bladder produce an internal pressure to urge the urine fluid from the bladder. Additionally in the present urine flow control device there is additional pressure produced from the urine fluid within the length of the urine flow lumen from at least the bladder to a lower or door or flap magnet. When these pressures are less than the magnetic attraction force between the stationary magnet and the flap magnet, the flap magnet remains securely closed, blocking the flow of urine through the urine flow control device. When these pressures overcome the attractive force of the stationary magnet and the flap magnet, the flap magnet pivotally moves to an open position permitting the urine fluid to flow through the magnetic valve and into the bell or ovoid shape output housing. The stationary magnet does not move and the portion of the housing where the stationary magnet resides includes openings to permit the urine fluid to pass when the flap magnet is in the open position. When the pressures reach the critical pressure value to overcome the magnetic attraction of the stationary magnet and the flap magnet, the flap magnet hingedly opens allowing the urine fluid to flow into the bell or ovoid shaped output housing. This critical pressure value is at least the combination of the pressures described above, namely the bladder pressure and the lumen pressure. 
     Additional pressures that combine to make up this critical pressure may also include momentum of the flowing urine fluid through the lumen and the urine flow control device as well as any gravitational forces. The bell or ovoid shaped output housing creates additional pressure by a tornado or vortex effect of the urine fluid flowing through the output housing, which will increase the speed of the urine flow and maintain a steady downward force or pressure keeping the flap magnet open until the bladder has been efficiently voided of urine. When the bladder is voided of urine and there is no more or little urine fluid flowing, the flap valve magnet hingedly closes which prevents reflux of urine into the bladder or the upper housing of the urine control device. 
     Different magnet strengths may be employed to accommodate greater or lesser critical pressures to open the magnetic valve flap magnet. These critical pressures may vary from person to person and could be optimized for an individual with different bladder efficiencies and associated muscle tones. Employing the urine control device of the invention with a catheter has the result of simulating “normal” un-cathaterized urination, which would keep the bladder from shrinking, will help prevent incontinence, and will help prevent urinary tract infections when the catheter is removed. 
     A sample port is provided through a sidewall of the cylindrical element portion of the urine flow control device. The cylindrical element is located intermediate the input port and the input housing. This construction would allow the sterile removal of a sample of urine from the device, for various medical tests to be performed thereon. 
     Another aperture is provided through the sidewall of the output port. This aperture is covered by a filter which is permeable to air, but fluid resistant, which allows air to enter the urine flow control device through the sidewall of the output port. The filter has a further property of preventing urine from leaking out of the output port. 
     The filter covered aperture allows for pressure equalization within the flow control device and creates tiny bubbles of air (approximately 20% oxygen) that travels down the lower lumen to the collection bag. This bubble action and the biocidal effect of oxygen will prevent bio-film from forming on the interior walls of the lumen or the collection bag. 
     The urine control device may be manufactured as a kit with a catheter for sterility. Alternatively, the lumen of the catheter may be cut intermediate the bladder and the urine collection bag, and the top portion of the lumen would be inserted into the input port of the urine control device and the bottom portion of the lumen would be inserted into the exit port of the urine control device. 
     It is accordingly an object of the invention to provide a flow control device having an inlet housing, with a magnet housing disposed in the inlet housing, the magnet housing having an aperture formed therein for receiving a stationary magnet therein, the magnet housing having an annular shoulder with an annular aperture formed therein and an annular ring projecting from the annular shoulder and surrounding the annular aperture. The flap magnet is disposed at the annular shoulder and for being attracted to the stationary magnet and held against the annular ring counter to pressure of a fluid in the flow control device. The stationary magnet and the flap magnet are sized for having an attraction force set to a predetermined value, which when exceeded by the pressure of the fluid acting on the flap magnet at the annular opening results in the flap magnet pivoting away from the annular aperture at an angle while remaining at least partially in contact with the magnet housing. 
     In accordance with another feature of the invention, an outlet housing is affixed to the inlet housing, and the outlet housing has an outlet housing opening formed therein, a flap magnet retention device is disposed in the outlet housing opening for preventing the flap magnet from dropping and loosing contact with the magnet housing. 
     In accordance with yet another feature of the invention, the flap magnet retention device defines a distance to the magnet housing which limits the angle the flap magnet pivots to 45 degrees or less. 
     In accordance with still another feature of the invention, the magnet retention device has an inside wall, and a diameter of the flap magnet is greater than a largest distance between the inside wall and an edge of the annular aperture, such that the flap magnet cannot be positioned against the magnet housing without completely covering the annular aperture. 
     In accordance with yet still another feature of the invention, the outlet housing defines an annular bowl-shaped chamber leading to a drain aperture at a base of the bowl-shaped chamber, the bowl-shaped chamber having an annular wall region extending longitudinally from the drain aperture. 
     In accordance with another feature of the invention, the bowl-shaped chamber is free of any structures, within the annular wall region, which would disrupt a vortex flow. 
     In accordance with yet another feature of the invention, the annular wall region extends substantially up to the magnet retention device. 
     In accordance with yet still another feature of the invention, the magnet retention device has an inside wall and strips extending between opposite points on the inside wall, the strips for preventing the flap magnet from being separated from the magnet housing. 
     In accordance with another feature of the invention, a predetermined value is set to release the flap magnet when a pressure of 7.5-10.5 inches of H 2 O is realized against the flap magnet. 
     In accordance with yet another feature of the invention, the magnet housing has an annular rim at the aperture of the magnet housing for retaining the stationary magnet in the aperture of the magnet housing. 
     In accordance with another object of the invention, a magnet housing has a stationary magnet at a first longitudinal end thereof; the magnet housing has an annular aperture formed therein at a second longitudinal end of the magnet housing opposite the first longitudinal end, a flap magnet is disposed at the second longitudinal end and for being attracted to the stationary magnet and held against the magnet housing counter to pressure of a fluid acting on the flap magnet, the stationary magnet and the flap magnet are sized for having an attraction force set to a predetermined value, which when exceeded by the pressure of the fluid acting on the flap magnet at the annular aperture results in the flap magnet pivoting away from the annular aperture at an angle while remaining at least partially in contact with the magnet housing, and an outlet housing disposed at the second longitudinal end of the magnet housing, the outlet housing defining an annular bowl-shaped chamber leading to a drain aperture at a base of the bowl-shaped chamber, the bowl-shaped chamber having an annular wall region extending longitudinally from the drain aperture, the bowl-shaped chamber being free of any structures, within the wall annular region, being disruptive to a vortex flow. 
     In accordance to an added feature of the invention, the outlet housing has an outlet housing opening formed therein, a flap magnet retention device is disposed in the outlet housing opening for preventing the flap magnet from dropping and loosing contact with the magnet housing. 
     In accordance with another added feature of the invention, the magnet retention device has an inside wall, a diameter of sthe flap magnet is greater than a largest distance between the inside wall and an edge of the annular opening, such that the flap magnet cannot be positioned against the magnet housing without completely covering the annular aperture. 
     In accordance with yet an additional feature of the invention, the annular wall region extends substantially up to the magnet retention device. 
     In accordance with yet still an additional feature of the invention, the magnet retention device has an inside wall and strips extending between opposite points on the inside wall, the strips for preventing the flap magnet from being separated from the magnet housing. 
     In accordance with an additional feature of the invention, the predetermined value is set to release the flap magnet when a pressure of 7.5-10.5 inches of H 2 O is realized against the flap magnet. 
     It is yet another object of the invention to have a magnet housing having a stationary magnet at a first longitudinal end of the magnet housing, the magnet housing having an annular aperture formed therein at a second longitudinal end of the magnet housing opposite the first longitudinal end, a flap magnet disposed at the second longitudinal end and for being attracted to the stationary magnet and held against the magnet housing counter to pressure of a fluid acting on the flap magnet, the stationary magnet and the flap magnet sized for having an attraction force set to a predetermined value, which when exceeded by the pressure of the fluid acting on the flap magnet at the annular aperture, results in the flap magnet pivoting away from the annular aperture at an angle while remaining at least partially in contact with the magnet housing. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an exploded view of the urine control device of the invention. 
         FIG. 2A  is a side view of the upper portion of the urine control device including the input port and the upper housing. 
         FIG. 2B  is a sectional view taken along lines  2 B- 2 B of  FIG. 2A . 
         FIG. 3  is a sectional view of the magnet housing of the urine control device with the lower magnet in the closed position. 
         FIG. 4  is a sectional view of the magnet housing of the urine control device with the lower magnet in the open position. 
         FIG. 5A  is an exploded partial section and cutaway view of some of the components of the urine control device. 
         FIG. 5B  is a side view of the outside of the assembled urine control device. 
         FIG. 6  is a view of the urine control device placed in line with the urine flow lumen from a catheter intermediate the bladder and the urine collection bag. 
         FIG. 7A  is a sectional view of the urine control device with the flap magnet in the closed position. 
         FIG. 7B  is a close up view of the portion of the urine control device shown in the circled area of  FIG. 7A . 
         FIG. 8A  is a sectional view of the urine control device with the flap magnet in an open position, showing representative urine fluid flow through the entire urine flow control device from the upper urine flow lumen to the lower exit housing and then to the lower urine flow lumen. The flow of urine with a vortex effect is seen in the lower housing. 
         FIG. 8B  is a close up view of the portion of the urine control device shown in the circled area of  FIG. 8A . 
         FIG. 9  is a perspective view of the magnet housing of the urine control device showing the plurality of openings for the urine fluid to flow by the stationary magnet towards the lower flap magnet. 
         FIG. 10A  is a side view of the magnet housing of the urine control device. 
         FIG. 10B  is a top view of the magnet housing of the urine control device. 
         FIG. 10C  is a bottom view of the magnet housing of the urine control device. 
         FIG. 10D  is a view of the magnet housing of the urine control device taken along lines  10 D- 10 D of  FIG. 10A . 
         FIG. 10E  is a view of the magnet housing of the urine control device taken along lines  10 E- 10 E of  FIG. 10A . 
         FIG. 11  is a plan view of magnet retention device. 
         FIG. 11A  is a section view taken at line  11 A- 11 A of  FIG. 11 . 
         FIG. 12  is a section view of the catheter to show the vortex flow of fluid in the bowl-shaped chamber. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now specifically to  FIG. 1 , an exploded view of the urine control device  10  to be employed downstream of a catheter, such as a Foley catheter  11  that has been inserted into the bladder  112  of a patient  111  as shown in  FIG. 6 . The urine control device  10  includes an upper or first lumen  82  which connects to the Foley catheter  11  and forms a passageway to receive urine fluid  120 A from the bladder  112 . The lumen  82  is connected to an input port  12  of the urine control device  10 . 
     In some embodiments, a sterile input port cover  18  is adapted to be fit atop the barbed input port  12  to keep the barbed input port  12  clean. The sterile input port cover  18  is removed and the upper lumen  82  frictionally interfits onto a central aperture  13  on the top of input port  12 . A lower or second lumen  84  is frictionally secured onto a barbed exit port  29  of the urine control device  10  and a locking cap microport cover  30  may secure the lumen  84  thereon. 
     In other embodiments, a kit would be formed with the Foley catheter  11 , and the first lumen  82  may already be secured in the input port  12  and the second lumen  84  may also already be secured to the exit of the barbed exit port  29 . 
     First lumen  82  forms the beginning of a central passageway  86  for urine fluid  120 A to flow through the entire length of the urine control device  10 . The flow of the urine fluid  120 A is shown in  FIG. 8A . The second lumen  84  completes the central passageway  86  from the urine control device  10  to the urine collection bag  110 . 
     Depending from the bottom of the input port  12  is a detent cylindrical element  62  having a cylindrical sidewall  63 . Cylindrical element  62  includes the central passageway  86 . A sampling port  16  is provided through the cylindrical sidewall  63  of the cylindrical element  62  to provide access to the central passageway  86  and to the urine fluid  120 A therein. Sampling port  16  has a self sealing silicone plug  16 A to provide access for a sample of urine when required. 
     Directly below and integral with the cylindrical element  62  is the upper, or inlet or first housing  60  and an attachable lower, outlet or second housing  14 . Therewithin, magnet housing  20  is supported within first housing  60  by a friction fit. Referring to  FIGS. 3 and 4 , magnet housing  20  includes a top aperture  68  to receive stationary magnet  22  securely therein. Stationary magnet  22  is press fit into aperture  68  and therefore is fixed in aperture  68  and does not move. To further secure stationary magnet  22 , an inwardly facing radial lip  150  is provided about the upper circular perimeter of the aperture  68 . As best seen in  FIG. 1  and  FIG. 5A , a flap magnet retention device  26  forms a lower boundary for the movable flap magnet  24  in a region at the bottom of the magnet housing  20 . The lower magnet retention device  26  has a top opening  64 , a cylindrical sidewall  70 , a bottom opening  72 , and a pair of perpendicular narrow strips  74 . The pair of perpendicular narrow strips  74  are located at the bottom opening  72  and are connected to the cylindrical sidewall  70  forming a barrier for flap magnet  24 . This barrier formed by strips  74  prevents the flap magnet  24  from exiting magnet retention device  26 . The strips  74  of retention device  26  also serve to limit the angle of the opening of flap magnet  24 , and prevent flap magnet  24  from moving into the bowl or chamber  17  of the second housing  14  except within retention device  26 . Preferably, an interior height  27 A of retention device  26  is not greater than approximately the diameter of lower magnet  24 . 
     The first housing  60  and the exit second housing  14  are preferably manufactured from K-resin® (a registered U.S. trademark of Chevron Phillips Chemical Company LP Ltd. of Woodlands, Tex.), a polycarbonate, which has a material property of being transparent. Other materials may be employed provided they have the required material properties. 
     The magnet housing  20  is preferably manufactured from silicone. This would include medical grade silicone which has a hardness value of 4 (+/−) 1 SHORE A as measured on a durometer. This gives a range of about 3-5 SHORE A. Other materials may be employed provided they have the required material properties. 
     In this discussion, and best seen in  FIG. 8A , the urine fluid flow  120  is shown passing through the urine flow control device  10 . The urine fluid flow  120  shows the flow path of urine fluid  120 A through the urine flow control device  10 . 
     The magnet housing  20 , includes a rim or annular shoulder  80 . Magnet housing  20  fits within first housing  60  such that should  80  fits into chamber  88  and against inner wall  88 A within diameter D 2 . Shoulder  80  is dimensioned appropriately such that the height of shoulder  80  is slightly greater than wall  88 A such that when second housing  14  is interfit into first housing  60  shoulder  80  will be compressed to create a compression seal against the top edge  77  of magnet retention device  26  and against top edge  15  of second housing  14 . The bottom central portion of shoulder  80  includes a flat annular ring  81 . Above the shoulder  80  are four openings  98  which pass through the outer sidewall  144  of the magnet housing  20  as shown in  FIGS. 9 and 10A . The openings  98  must be sufficiently large to permit struvite crystals or other stones or crystals which be entrained in the urine fluid flow  120  to pass through the openings  98 . By making the openings  98  large enough, blockage by the struvite crystals or other material that may be entrained in the urine fluid flow  120  is prevented. 
     When flap magnet  24  is in the open position as shown if  FIG. 4  and  FIG. 8A , urine fluid  120  will flow though the four openings  98 , through aperture  105 , over flap magnet  22  and into the second housing  14  which has an ovoid internal shape, in a swirling action. This swirling action of the urine fluid flow  120 A is shown in  FIG. 8A  and  FIG. 12 . In  FIG. 8A  the vortex flow is created and is shown with a portion of the urine fluid  120 A shown in a vortex as the urine fluid  120  flows from above and against flap magnet  24  into and through the interior bowl-shaped chamber  17  of second housing  14  leading to a drain aperture  17 A at the base of chamber  17 . Chamber  17  includes an internal annular wall region  17 B extending from the drain aperture  17 A towards the magnet retention device  26 . Also see  FIG. 7A .  FIG. 8A  shows a symbolic portion of the urine flow  120  in second housing  14  to illustrate the vortex, swirling or tornado effect within chamber  17 . This effect is based on Bernoulli&#39;s principles that for an inviscid fluid (ideal fluid with no viscosity) flow, an increase of speed of the fluid occurs simultaneously with a decrease of pressure. Thus, when the internal body pressure of the bladder  112  and the urine flow  120  reaches a pressure in the range of 7.5-10.5 inches of H 2 O, flap magnet  24  releases in a hinging motion directing the urine fluid flow  120  into a direction which will optimize the direction and flow of urine  120 A such that the increased speed of the urine flow  120  will cause flap magnet  24  to remain in an open position until the magnetic attraction between stationary magnet  22  and flap magnet  24  reaches a level that the flap magnet  24  will close because of the greater attraction of stationary magnet  22 . As a result, the direction of the hinged flap magnet  24 , with Bernoulli&#39;s principal of the fluid flow  120 , will develop a tornado effect within chamber  17  with the urine flow  120  which will increase the speed of the urine flow  120  and maintain a steady downward force keeping the flap magnet  24  open until the bladder  112  has been efficiently voided of urine  120 . 
     It is noted that bowl-shaped chamber  17  as shown preferably has relatively smooth internal walls, an annular wall region extending longitudinally from the drain aperture  17 A, and the bowl-shaped chamber is free of any structures, within the annular wall region that would be disruptive to a vortex flow Further, chamber  17  would not include any internal structure that would disrupt or inhibit a vortex flow. 
     In a working example, the distance between the stationary magnet  22  and flap magnet  24  is 0.630 inches +0.005/−0.000 inches. The Gauss strength of the stationary magnet  22  is 1225.0+/−10.0 Gauss. The Gauss strength of the flap magnet  24  is 635.0+/−15.0 Gauss. The pressure of the liquid to open the flap magnet  24  is 7.75-10.5 inches/H 2 O. The amount of the surface area of the flap magnet subject to pressure is A=(Pi)(r 2 ). The diameter of the opening  105  is 0.201 inches, the radius of the opening  105  is 0.1005 inches. 
     The stationary magnet  22  and the flap magnet  24  are oriented in such a fashion that the magnetic fields attract. It is well known that magnets have poles, one positive or north, designated by (N) and one negative or south, designated by (S). The stationary magnet  22  may have a bottom portion  34  which is north (N) and a top portion  32  which is south (S). In this arrangement, the flap magnet  24  will have a top portion  36  which is south (S) and a bottom portion  38  which is north (N). This arrangement is best seen in  FIGS. 3 and 4 . 
     Alternatively, the stationary magnet  22  may have a bottom portion  34  which is south (S) and a top portion  32  which is north (N). In this case, the flap magnet  24  must have a top portion  36  which is north (N) and a bottom portion  38  which is south (S). This alternative embodiment is not shown in the  FIGS. 3 and 4 . 
     In either of these magnet arrangements, the flap magnet  24  is attracted to the stationary magnet  22 . Both the flap magnet  24  and the stationary magnet  22  are generally cylindrical with a diameter and height. The stationary magnet  22  and the flap magnet  24  may be of different or have generally the same diameter; however, generally the height of the stationary magnet  22  is greater than the flap magnet  24 . 
     The diameter or length L 2  of the flap magnet  24  is chosen to be greater than the distance L 1  formed starting from the inner sidewall  26 A of the magnet retention device  26  to the far side of aperture formed by the bottom of the central urine passageway  105 . This is best seen in  FIG. 8B . In the event that flap magnet  24  gets loose, it will always close having sufficient diameter L 2  to completely arrest the urine fluid flow through the central urine passageway  105 . 
     In a working example, stationary magnet  22  has a diameter of 0.361 inches and a height of 0.253 inches and has a Gauss value of about 1225.00 (+/−) 10.0 with the north side of the stationary magnet  22  in the towards input port  12  The flap magnet  24  has a diameter of 0.375 inches and a height of 0.091 inches and a Gauss value of about 635.00 (+/−) 15.0 with the same orientation of north as the stationary magnet  22 . When the pressure in the first housing  60  reaches about 7.75 to 10.5 inches of H 2 O [pure water at 4 degrees Centigrade], the flap magnet  24  opens in a hinge like action. The opening of the flap magnet  24  is in response to sufficient pressure bearing down on the top  36  of the flap magnet  24  through aperture  105 . 
     When the flap magnet  24  is in an open position, it directs the urine fluid flow  120  in a specific direction into the chamber  17  of second housing  14  which starts the vortex action. This is because the flap magnet  24  hingedly opens and the urine fluid flow  120  is directed against and over flap magnet  24  to one side and downward into the chamber  17  of second housing  14 . Through action of Bernoulli forces, the chamber  17  of second housing  14  has a lower internal pressure than the pressure in chamber  88  of first housing  60  drawing the urine fluid  120 A into the second housing  14 . The internal shape of chamber  17  of second housing  14  combined with the lower pressure in chamber  17  induces the urine fluid flow  120  to move in a vortex or swirling motion as it passes over and against flap magnet  24  and into the chamber  17  and through second housing  14  to the drain aperture  17 A. The combination of the lower pressure, the induced vortex, and the directional flow over the flap magnet  24  when flap magnet  24  is in the open position aids in draining the urine fluid  120 A more completely from device  10  and the bladder  112 . This aids in removing the old, rancid, possibly infected urine fluid  120 A which may remain in the bladder  112  when using a prior art conventional continuous flow catheter. 
     This magnetic attraction between the stationary magnet  22  and flap magnet  24  holds the lower magnet  24  magnetically to the bottom side of shoulder  80  and to annular ring  81 . When flap magnet  24  is in a closed position, it blocks and prevents the urine fluid flow  120  through the passageway  86  and through aperture  105  towards the second housing  14 . As shown in  FIG. 3  the flap magnet  24  top portion  36  is in a closed position below central valve urine passageway  105  of shoulder  80 . However, the flap magnet  24  will move to an open position when the critical pressures exceed the magnetic attraction between the stationary magnet  22  and the flap magnet  24 . Due to the magnetic field lines between the stationary magnet  22  and the flap magnet  24 , when the flap magnet  24  opens, the flap magnet  24  moves in an angular fashion creating an opening in the passageway  105  which opens passageway  86  allowing urine fluid flow  120  to continue within passageway  86  below the position of flap magnet  24 . When the critical pressure overcomes the magnetic attraction threshold between the stationary magnet  22  and the flap magnet  24 , the flap magnet  24  opens angularly as shown in  FIG. 4 . The maximum open position of flap magnet  24  will be until flap magnet  24  rests against one or more of the perpendicular narrow strips  74  of the lower magnet retention device  26 . 
     The ability of the flap magnet  24  to open in an angular fashion is attributed to the arrangement of the fixed, unmovable stationary magnet  22  with respect to the angularly movable flap magnet  24 . In this arrangement magnetic fields are generated by the stationary magnet  22  which attract, support and hold the flap magnet  24  against the shoulder  80  and lip  81 . Additionally the flap magnet  24  generates magnetic fields which attract the stationary magnet  22 . When the critical pressure is greater than, and thus overcomes, the attractive forces between the upper stationary magnet  22  and the movable flap magnet  24  then the lower stationary magnet  24  is angularly displaced until at a maximum, a portion of flap magnet  24  rests on the lower magnet retention device  26 . Due to micro-discontinuities and uneven magnetic fields generated and interacting between the stationary magnet  22  and the movable flap magnet  24 , the movable flap magnet  24  will move downward in an angular fashion, with one part of the top portion  36  of the movable flap magnet  24  resting against lip  81  of shoulder  80  or magnetically closely attracted to shoulder  80  and lip  81 . The bottom portion  38  of flap magnet  24  is towards or resting against the magnet retention device  26 . 
     The silicone magnetic housing  20  frictionally interfits into the upper housing  60 . Upper housing  60  rotatably attaches the lower housing  14  to the upper housing  60  securing the magnet housing  20  by a barb  42  located on the interior of the upper housing  60  which fits into a groove  44  located in the lower housing  14 . When the barb  42  is rotated in the groove  44  the upper housing  60  is secured to the lower housing  14 . 
     Lower housing  14  has a generally ovoid shaped inner chamber  88 . Depending from the bottom of the lower housing  14  is a barbed exit port  29  to receive lumen  84 . A microport hole  28  passes through the sidewall of the barbed exit port  29 . The microport hole  28  allows atmospheric air to enter the passageway  86 . The microport hole  28  is covered by a microfilter covering  28 A, which attaches by adhesive or is frictionally held to the sidewall of barbed exit port  29  to cover hole  28 .  FIG. 5A  shows three of the four microport holes  28  which provide a passageway for entry of the atmospheric air through the microport holes  28 . Holes  28  covered with microport covering  28 A allow air into passageway  86  but do not allow fluid flow  120  to exit through hole  28 . Hole  28  allows for pressure equalization in the device  10  and create tiny cleansing bubbles of air that travel down the passageway  86  to the collection bag  110 . Cover  30  has for openings  28 B to allow atmospheric communication to hole  28 . This introduction of atmospheric air which contains approximately twenty percent (20%) oxygen is biocidal to many microorganisms. The atmospheric oxygen which enters through the microfilter covering  28 A and into the microport hole  28  flows into passageway  86  and into lumen  84 . Lumen  84  forms the remainder of passageway  86  and the urine fluid flow  120  continues along passageway  86  to the urine collection bag  110 . The biocidal properties of the oxygen entering through the microport hole  28  prevents bio-film from forming on the interior passageway  86 , of the second lumen  84  and the interior of the collection bag  110 . The bio-film formation is arrested due to the fact that the gaseous oxygen kills the microorganisms. This helps prevent reflux and microbiological contamination of the urine flow control device  10  and the associated catheter and urine collection bag  110 . By preventing such reflux, urinary tract infections are reduced. 
     Referring now specifically to  FIG. 2A , a plan view of the upper portion of the urine control device  10  including the barbed input port  12  and the upper housing  60  is shown. A cylindrical element  62  is shown intermediate the barbed input port  12  and the upper housing  60 . A silicone plug  16 A is shown passing through the sidewall of the cylindrical element  62 . The self sealing silicone plug  16 A, permits access to take a sample of the urine fluid  120 A that comes from the patient for any medical tests that may be required. 
     Referring now specifically to  FIG. 2B . a cut-away view taken along lines  2 B- 2 B of  FIG. 2A  with the silicone cylindrical plug  16 A not in place. A central aperture  13  on the top of barbed input port  12  is designed to receive the first lumen  82  of the catheter therein. A central passageway  86  passes through the center of the barbed input port  12  and then into the center of cylindrical element  62  and then into the generally bell shaped upper portion chamber  88  of the input or first housing  60 . Two barbs  42  are located at the bottom  90  of the upper housing  60 , along the interior sidewall  88 B. 
     A sample port  16  passes through the sidewall  63  of the cylindrical element  62  allows sampling of urine fluid  120 A passing through the central passageway  86 . The upper portion chamber  88  of the interior of the upper housing  60  is bell shaped and expands to a maximum diameter D 1 . Below the bell shaped upper housing  60  is an interior cylindrical inner sidewall  88 A with a diameter D 2  which is somewhat larger than diameter D 1 . Immediately below the interior cylindrical portion sidewall  88 A with a diameter of D 2  is second cylindrical shoulder portion inner sidewall  88 B with a diameter D 3 . Diameter D 3  is somewhat larger than diameter D 2 . The internally disposed barbs  42  are located on inner sidewall  88 B, on the portion of the interior upper housing  60  which has diameter D 3 . The reason for the staggered diameters of the interior of the upper housing  60  is so that it may receive the magnet housing  20  therein such that annular shoulder  80  fits within and is frictionally held in place by wall  88 A. Once the magnet housing  20  is in place, the lower housing  14  is interfit into the bottom  90  of the first housing  60 , where the barbs  42  fit into a groove  44 , which when rotated, lockably secures the upper housing  60  to the lower housing  14  and the top of second housing  14  has a compression fit against shoulder  80  of magnet housing  20  to form a leak free fit. 
     Referring now specifically to  FIG. 3 , the magnet housing  20  of urine control device  10  is shown with flap magnet  24  in the closed position. The magnet housing  20  is interfit inside the upper housing  60 . Stationary magnet  22  is interfit into stationary magnet housing aperture  68 . Stationary magnet housing  68  includes an interior cylindrical sidewall  140  with columns  155 . The columns having a top  142 . The stationary magnet  22  fits into the opening formed by the cylindrical sidewall  140  and rests on surface  142 .  FIG. 3  also shows the top portion  32  of the stationary magnet  22  being of a south (S) polarity and the bottom side  34  of the stationary magnet  22  being of a north (N) polarity. Additionally,  FIG. 3  shows several of the urine passageways  98  in the magnet housing  20  above shoulder  80  which lead to a central valve urine passageway  105 . Central valve urine passageway  105  is part of central passageway  86  and provides the opening for the urine flow  120  from above the magnet housing  20  through magnet housing  20  when the flap magnet  24  is in the open position as shown in  FIG. 4 . In  FIG. 4 , magnet  24  is shown displaced by the angle  40 . This angle is preferably 30 degrees to 45 degrees. 
     In  FIG. 4 , the weight and pressure of the urine flow  120  from the bladder causes the flap magnet  24  to angularly displace, the displacement angle shown at  40  allowing the urine to flow to the lower housing  14  where it then flows to the urine collection bag  110 . The urine flow  120  through the urine control device  10  will be best seen in  FIG. 5A  and  FIG. 8A , where the direction of flow is indicated by arrows and line  121  in  FIG. 5A . 
     At the bottom of the second housing  14  is at least one micropore hole  28  which is seen best in  FIG. 7A . The microport hole  28  is covered by a microport filter  28 A which may be attached with an adhesive and permits outside air to enter the urine stream through microport hole  28  while not permitting the urine stream from leaving the urine control device  10 . Such micro filter  28 A is manufactured by TAPESPEC® of New Zealand. A microport cover  30  covers the micropore hole  28  and microport filter adhesive  28 A when desired which is shown in  FIG. 1 . The air introduced into the urine flow  120  is approximately 20% oxygen which is a highly toxic gas for many types of microorganisms. The oxygen is quite lethal and creates a hostile environment which kills many microorganisms in the second lumen  84  and urine retention bag  110 . This prevents or minimizes the possibility of infection of the patient and extends the length of time before the urine retention bag  110  would need to be replaced. 
     Referring specifically to  FIG. 5B  a plan view of the urine control device  10  is shown assembled. The first housing  60  is shown connected to the second housing  14 . Once the sterile input cover  18  is removed, the upper lumen  82  is fit over the barbed input port  12 . The microport cover  30  is affixed over the barbed exit port  29 . 
     Referring specifically now to  FIG. 6 , a view of the urine control device  10  placed in line with the first lumen  82  of a catheter which has been inserted into the bladder  112  of the patient  111  and a second lumen  84  connected to a urine collection bag  110  is shown. This is generally how the urine control device  10  is employed with a Foley catheter  11  inserted into a patient  111 . The catheter  11  drains the urine fluid  120 A from the bladder  112  to the urine flow control device  10 . In many cases, but not all, the urine storage bag  110  may be attached to a leg by a band  110 A. A Luer Lock connector  110 B allows air to fill a balloon  110 C once the Foley catheter  11  is inserted into the bladder  112 . When the balloon  110 C is inflated the catheter  11  will remain in the bladder  112 . 
     Referring now specifically to  FIG. 7A  a sectional view of the urine control device  10  with the flap magnet  24  in the closed position, preventing any urine flow  120  from the bladder and above second magnet  24 . Central passageway  86  provides a channel for urine flow  120 . Flap magnet  24  is held against a flat annular ring  81  by the magnetic attraction between first magnet  22  and flap magnet  24 . The diameter of the flap magnet  24  is chosen to be such that when flap magnet  24  is in a closed position within magnet retention device  26 , the central urine passageway  105  through the flat annular ring  81  will be completely blocked and sealed by flap magnet  24 . Annular ring  81  prevents the top  36  of the flap magnet  24  from becoming vacuum locked against shoulder  80 . 
       FIG. 7B  is an enlarged view of the portion of the urine control device  10  shown in the circled area of  FIG. 7A .  FIG. 7B  shows the spatial arrangements of a portion of the annular shoulder  80 , the annular ring  81 , the flap magnet  24  in a closed position, the bottom  152  of the annular shoulder  80 , the intersection of the top  27  of the magnet retention device  26  with the bottom  152  of the annular shoulder  80 , the intersection of the top  15  of second housing  14 , with both the bottom  152  of the annular shoulder  80  and the step down  160  between the inner sidewall  88 A and interior sidewall  88 B. Annular shoulder  80  extends a small distance below inner wall  88 A. Shoulder  80  is made of medical grade silicon or equivalent and both the magnet retention device  26  and the second housing  14  are made from a polycarbonate of a K resin type or equivalent. The medical grade silicon forms an elastic compression gasket  162  at the point of the compression of shoulder  80  by the top  15  of second housing  14  and the top  27  of retention device  26 . This elastic compression gasket  162  seals the intersection of element  15  and element  152  averting the possibility that any urine fluid  120 A may escape. In  FIG. 7B , the compression gasket is shown in a compressed state. 
     Barb  42  is shown locked in groove  44  preferably forming a one-time connection between the first housing  60  and the second housing  14 . The urine flow control device  10  is designed for a one time use, not to be reused. If the first housing  60  and the second housing  14  are forced open, the barb  42  would fracture and it would not be possible to put the first housing  60  and the second housing  14  together again. 
     Referring now specifically to  FIG. 8A  a sectional view of the urine control device  10  with the flap magnet  24  being forced to an open position by the pressure and the weight of the urine in the bladder  112  and the first lumen  82 , allowing the urine to flow to the second housing  14 , to the second lumen  84 , and then to the urine collection bag  110 . The flap magnet  24  is hingedly displaced in an angular fashion, and is shown as the angle designated by the curved line  40  in  FIG. 4 . 
     Flap magnet  24  opens angularly as indicated by the curved line shown at element  40 . The angle may vary to any angle within the range of above zero degrees to about 60 degrees where it is stopped by the lower magnetic retention device  26 . 
     The momentum of the urine flow  120  along the passageway  86  is caused by the pressure exerted by the bladder  112 , the weight of the urine fluid  120 A itself, and the velocity of the urine fluid  120 A in the urine flow  120 . When the momentum of the urine fluid  120 A in the urine flow  120  falls below a critical level, the flap magnet  24  moves angularly back to the closed position, closing off the urine flow  120  in the passageway  86  and the central urine passageway  105  through the center of the shoulder  80 . 
     The urine flow  120  starts in the bladder  112  and proceeds through the first lumen  82  to the top of the urine control device  10 . The urine flow  120  exits the first lumen  82  into the upper part of the urine control device  10  where it enters a central passageway  86  and proceeds into the inside of the bell shaped first housing  60 . The central passageway  86  is the passageway for the urine flow  120  which passes through the urine control device  10 . Inside the bell shaped input housing  60  is the magnet housing  20 . The flap magnet  24  blocks the urine flow  120  and causes the urine flow  120  to move to the region intermediate the inner sidewalls  125  of the bell shaped input housing  60  and the area where the magnet housing begins. This allows the urine flow  120  to flow about the magnet housing  20 . This opening between the inner sidewalls  125  of the bell shaped input housing  60  and the outer sidewalls  144  of the magnet housing  20  is part of the passageway  86  and provides for the urine flow  120  down the outer sidewalls  144  of the magnet housing  20  until the urine  120  reaches the shoulder  80 . A distance D seen in  FIG. 3  exists between the outer sidewall  144  of the magnet housing  20  and the inner sidewall  125  of housing  60 . 
     Above the shoulder  80  are the outer sidewalls  144  of the magnet housing  20  showing the four openings  98  which connect to the central urine passageway  105  which is best seen in  FIG. 9 . Located on the interior side of the interior cylindrical sidewall  140  are a plurality of vertically oriented shoulders  155 . These act as a bottom support for the stationary magnet  22 . The stationary magnet  22  bottom portion  34  rests upon the top  142  of the aforementioned shoulders  155 . This, in combination with the stationary magnet securing lip  150  keeps the stationary magnet  22  in place and stationary. 
     At the bottom of the outer sidewalls  144  of the magnet housing  20  there are four openings  98 . The urine flow  120  enters the four urine passageway openings  98  located above the shoulder  80  which lead to a central urine passageway  105 , which allows the urine flow  120  to pass from the upper housing  60  through the passageway  105  to the top portion  36  of the flap magnet  24 . At this point, the forces of the magnetic attraction between the stationary magnet  22  and the flap magnet  24  are opposed by the weight of the urine  120 , the force of pressure of the urine from the bladder, and any momentum from the urine flow  120 . When the force of the urine in the urine flow  120  overcomes the magnetic attraction force between the stationary magnet  22  and the flap magnet  24  the urine will cause flap magnet  24  to move angularly downward to an open position. At this point the urine flow  120  is through the central urine passageway  105  back to the central passageway  86  into the ovoid shaped lower exit housing  14 . The urine flow  120  takes on a vortex or tornadic path into and inside the ovoid shaped or bowl-shaped chamber  17  of second housing  14 . This vortex or tornadic path inside the chamber  17  of second housing  14  creates a low pressure area within chamber  17 , lower pressure than in first housing  60  which increases the velocity and momentum of the urine flow  120  along the passageway  86  helping to empty the bladder  112  more completely. The urine flow  120  then enters the hollow center of the barbed exit port  29  where it is connected with the second lumen  84  and finally the urine flow  120  discharges into the urine collection bag  110  after the bladder  112  has been emptied. 
       FIG. 8B  is an enlarged up view of the portion of the urine control device shown in the circled area of  FIG. 8A .  FIG. 8B  shows the spatial arrangements of a portion of the annular shoulder  80 , the annular ring  81 , the flap magnet  24  in an open position, the bottom  152  of the annular shoulder  80 , the bottom  153  of annular ring  81  the intersection of the top  27  of the flap magnet retention device  26  with the bottom  152  of the annular shoulder  80 , the point of contact of outer wall  165  of the flap magnet retention device  26  and the inner wall  165 A of second housing  14 . Flap magnet  24  is shown in an opened position, hingedly open at an angle shown and described by the curved line  40 . 
     When flap magnet  24  is opened, the upper left corner  176  of the flap magnet  24  may touch a point  172  of the bottom  152  of annular shoulder  80 . Additionally, point  178  on the top  36  of the flap magnet  24  may touch the point  174  on the bottom  153  of flat annular ring  81 . Further, the lower  38  right corner  180  of flap magnet  24  may touch at point  182  or nearby by intersecting a point  182  on the pair of perpendicular narrow strips  74  which traverse the bottom opening  72  of the flap magnet retention device  26 . 
     Flap magnet  24  may hingedly open in any radial direction, point  172  may be anywhere in a ring of positions located on the bottom  152  of the annular shoulder  80 .  FIG. 8B  shows one possible configuration with the flap magnet  24  opened. As such, the previous paragraph describes what is shown in  FIG. 8B . The flap magnet  24  could be oriented where the upper right corner  184  would be intersecting a point at the bottom  152  of annular shoulder  80 . In this case, the flap magnet  24  would be opening 180 degrees (not shown) from the orientation shown in  FIG. 8B . 
       FIG. 9  is a perspective view of the magnet housing  20  showing the four openings  98  in which the urine flow  120  enters, to further pass through the central urine passageway  105  located centrally and through the shoulder  80 . The urine flows through the plurality of openings  98 , passes down through the central urine passageway  105  and comes in contact with the top  36  of the lower magnet  24 . When the urine fluid  120 A in the urine flow path  120  reaches a critical force value which overcomes the magnetic attraction between the stationary magnet  22  and flap magnet  24 , the flap magnet  24  angularly opens as if on a hinge. Thereafter when the urine fluid  120 A is emptied, flap magnet  24  returns to the closed position closing the central urine passageway  105  once the forces of the urine fluid  120 A in the urine flow path  120  falls below the critical value. Because of the tornado or vortex effect in chamber  17  the urine flow  120  will continue and allow the urine above flow magnet  24  to empty into chamber  17  and be discharged from the urine control device  10 . 
       FIG. 10A  is a side view of magnet housing  20  of the urine control device  10 . The top  151  of annular shoulder  80  connects through the four openings  98  in the magnet housing  20  to the central urine passageway aperture  105 . The top  151  of the annular shoulder  80  acts as a floor which passes into the interior of the magnet housing  20  to the central urine passageway aperture  105 . 
       FIG. 10B  is a top view of the magnet housing of the urine control device  10  with the stationary magnet  22  removed. It can be seen that the top  151  of the annular shoulder  80  passes into the interior of the magnet housing  20  to the central urine passageway aperture  105 . Four vertical columns  155  are shown about 90 degrees apart, the bottom  34  of the stationary magnet  22  would rest on the top  142  of each of these four vertical columns  155 . An upper lip  150  is shown which would hold the top  32  of the stationary magnet  22  keeping the stationary magnet  22  fixed intermediate the upper lip  150  and the top of the four columns  155 . The upper lip  150  also ensures that the urine flow  120  does not enter the portion of the magnet housing  20  where the stationary magnet  22  resides. 
       FIG. 10C  is a bottom view of the magnet housing  20  of the urine control device  10 . The central urine passageway aperture  105  is shown passing through both the annular shoulder  80  and the flat annular ring  81  which depends centrally from the bottom  152  of the annular shoulder  80 . The bottom  153  of the flat annular ring  81  is shown. 
       FIG. 10D  is a view of the magnet housing of the urine control device taken along lines  10 D- 10 D of  FIG. 10A . The top  151  of the annular shoulder  80  passes into the interior of the magnet housing  20  to the central urine passageway aperture  105 . Four vertical columns  155  are shown in section and about 90 degrees apart, the bottom  34  of the stationary magnet  22  would rest on the top of each of these four vertical support columns  155 . 
       FIG. 10E  is a sectional view of the magnet housing  20  of the urine control device  10  taken along lines  10 E- 10 E of  FIG. 10A . 
     The first housing  60  and second housing  14  are connected with twist-lock assemblies to assure the first housing  60  and second housing  14  are connected correctly and without adhesives. The silicone magnet housing  20  acts like a gasket between first housing  20  and lower magnet  24  to prevent leakage when lower magnet  24  is in a closed position. 
     A urine flow cycle begins with the flap magnet  24  in a closed position. When the fluid pressure reaches 7.75 to 10.5 inches of H 2 O, the fluid pressure against flap magnet  24  results in a force which overcomes the attraction between the magnet  24  and magnet  22  and opens flap magnet  24 . The force that opens flap magnet  24  is from the fluid pressure zone P 1  in the chamber  88 , which forces flap magnet  24  into an open position. Once the flap magnet is open, the fluid pressure P 1  zone is above the restricted passageway of annular opening  105 . P 1  is within chamber  88  and is shown at  FIG. 8A . Fluid pressure P 2  in the restricted passageway of annular aperture or opening  105  is greater than fluid pressure P 1  within chamber  88  because of the fluid flowing through the restricted annular opening  105 . According to the Bernoulli effect, the velocity of the fluid at the restricted area  105  is faster than the fluid speed in chamber  88  and the area above the annular opening  105 . Just downstream and below the opening  105 , the fluid pressure at P 3  is lower or less than fluid pressure P 2 . This lower pressure P 3  causes an increase in the velocity of fluid in the chamber  17 . The bowl-shape of chamber  17  causes a vortex fluid effect in chamber  17 . This vortex can only be maintained with lower pressure P 3  and increased speed of the fluid. The low pressure area p 3  pulls the fluid from above the restricted annular opening  105  and evacuates the remaining fluid above the restricted annular opening  105  while keeping the flap magnet  24  open. The increased velocity of the fluid at the restricted annular opening  105  keeps flap magnet  24  open for a longer period of time counter to the magnetic attraction force between the stationary magnet  22  and flap magnet  24 . The force resulting from the flowing fluid at opening  105  overcomes the magnetic attraction and keeps magnet  24  open while the remaining fluid drains from the bladder and housing  60 . Further, as the fluid leaves chamber  17  it pulls outside air into passageway  86  which decreases the fluid pressure which allows the fluid to drain into the collection bag pulling outside air through opening  28  which results in microscopic air bubbles being pulled into the fluid stream in passageway  86  and into collection bag  110 . 
     When the fluid  120  above the flap magnet is drained into chamber  17  and there is little or no fluid left above flap magnet  24 , then flap magnet closes against the magnet housing  20  and the cycle starts over. New fluid enters the bladder  112  and the fluid in the bladder drains to the first housing  60 . When the fluid pressure reaches the critical value of 7.5-10.5 inches of H 2 O against the flap magnet  24 , the flap magnet  24  opens again. 
     While the invention has been described in its preferred form or embodiment with some degree of particularity, it is understood that this description has been given only by way of example and that numerous changes in the details of construction, fabrication, and use, including the combination and arrangement of parts, may be made without departing from the spirit and scope of the invention.

Technology Category: 2