Abstract:
A system is provided for collecting bodily fluids, and particularly urine from the bladder of a patient, comprising a catheter inserted into the bladder, a low pressure, cyclic magnetic valve coupled to the catheter, a collection bag, and, a quick-release coupler interposed between the magnetic valve and the collection bag.

Description:
RELATED APPLICATION 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 11/745,473, filed May 8, 2007 and entitled “COUPLER.” 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to medical devices, and, more particularly, to a system for the collection and disposal of bodily fluids following surgery or in patients with certain medical conditions. 
       BACKGROUND OF THE INVENTION 
       [0003]    Normal bladder function includes cyclic filling of the bladder with urine and periodic voiding when pressure buildup reaches a noticeable level. The bladder detrusor muscle controls voiding of the bladder and must be exercised like any other muscle to maintain healthy tone. When healthy, the bladder periodically empties or washes out, allowing bacteria and other potentially harmful micro-organisms to exit the body thus preventing infection. 
         [0004]    A variety of medical conditions can interfere with the normal function of the bladder and the bladder detrusor muscle. When patients have difficulty urinating, a Foley catheter or other indwelling catheter is usually employed to open the bladder and allow voiding of urine. In typical applications, the catheter is coupled to a collection bag, either directly or through a length of tubing, and urine from the bladder is allowed to drip in an uncontrolled fashion into the bag. When the bag becomes filled with urine, the attendant applies a clamp to the catheter or tubing, detaches the bag for emptying or replacement, and then re-attaches a bag. After a new or empty bag is attached, the clamp may be removed. 
         [0005]    A number of disadvantages and difficulties are created with systems of the type described above. Clamps applied to the catheter or tubing often create less than perfect seals, and urine can leak out when the bag is being changed or emptied. Serious problems can occur if the clamp is left in place for too long of a time period, e.g. if the attendant becomes distracted or called away, by allowing the buildup of urine upstream from the clamp and in the bladder. Further, the bag is often difficult to detach and re-attach to the catheter or tubing to ensure no leakage occurs at that connection. 
         [0006]    Additionally, many problems arise with the catheters used in such systems, particularly considering that the urine is allowed to flow in an essentially constant drip from the bladder, through the catheter and into the collection bag. In many cases, urine can pool and stagnate in the neck of the bladder when using a catheter causing struvite crystal encrustations. The pH of urine may change from a normal level to an ammonia state when pooled, resulting in precipitation and enlargement of struvite crystals on the indwelling catheter. Stagnation of urine may also create infections which can migrate to other areas of the body. Painful bladder spasms are another problem created by indwelling catheters, particularly during long periods of catheterization, which causes the bladder to cease its normal cycle of filling and flushing. 
         [0007]    Little has been done to address the problems with prior urine collection systems, and other systems for collecting bodily fluids. Catheter-type devices have been proposed which employ siphoning, suction and various types of awkward manually externally controlled cycling apparatus and procedures. No systems are capable of permitting the bladder to fill to a normal level, void or washout all at one time, while minimizing the buildup of infectious contaminants or their entry into the system and allowing the convenient detachment of a filled collection bag from the system with a minimum of effort and no leakage. 
       SUMMARY OF THE INVENTION 
       [0008]    This invention is directed to a system for collecting bodily fluids, and particularly urine from the bladder of a patient, comprising a catheter inserted into the bladder, a low pressure magnetic valve coupled to the catheter, a collection bag, and, a quick-release coupler interposed between the magnetic valve and the collection bag. 
         [0009]    Different types of collection bags may be employed in the system of this invention, including bags used when the patient is sleeping and mobile bags which may be attached to the leg or around the waist of a patient. Each bag has an inlet provided with a flap valve or the like to prevent the escape of fluid once it enters the bag, and a drain valve is located opposite the inlet to empty the contents of the bag. 
         [0010]    The magnetic valve is a low pressure cyclic valve which is responsive to upstream fluid pressure in the system. The valve is held in the closed position by operation of magnetic force, the magnitude of which may be varied, and then moved to an open position when the pressure of the fluid contained in the bladder, catheter and tubing upstream from the valve reaches a selected level. As a result, urine within the bladder is voided or “washed out,” all at once, taking with it bacteria and other microbes which may otherwise accumulate in the area of the neck of the bladder. The magnetic valve of the system herein provides enhanced patient safety and comfort, and may help to prevent the bladder detrusor muscle from becoming flaccid or atonic during the period of catheterization. 
         [0011]    The coupler of the system of this invention comprises an actuator housing coupled to the inlet of the collection bag, and a plunger housing coupled to tubing extending from the magnetic valve. Both of the housings are formed with a passageway for transmitting fluid exiting the magnetic valve to the collection bag. As the housings are connected together, a plunger located in the passageway of the plunger housing is moved from a closed position to an open position by an actuator mounted in the actuator housing in such a way that a seal is continuously maintained in the plunger housing to prevent the escape of fluids from its passageway. A quick-release locking mechanism maintains the two housings in a locked position when the plunger is in the open position, and may be easily activated to permit separation of the housings from one another when it is desired to empty or replace the collection bag. 
         [0012]    In one presently preferred embodiment, fluid from the magnetic valve enters the inlet end of the passageway formed in the plunger housing. With the plunger in a closed position, a seal is created at the outlet end of the passageway to prevent leakage of fluid from the plunger housing. A second seal is mounted near the outlet end of the passageway which extends outwardly from the exterior surface of the plunger housing. 
         [0013]    The actuator housing is movable relative to the plunger housing. An inner section of the actuator housing slides along the exterior surface of the plunger housing and engages the second seal protruding from the exterior surface of the plunger housing. A seal is created at that interface throughout substantially the entire period of contact between the two housings. The actuator is located downstream within the passageway of the actuator housing such that it does not contact the leading end of the plunger until after a seal is formed between the inner section of the actuator housing and the exterior surface of the plunger housing. Consequently, when the actuator does move the plunger to an open position, unseated from the outlet end of the passageway in the plunger housing, the two housings are sealed together preventing the escape of any fluids from the plunger housing except into the passageway of the actuator housing. 
         [0014]    The locking mechanism is coupled to the exterior surface of the plunger housing and is effective to maintain the two housings connected to one another while the plunger is in the open position. A release button of the locking mechanism allows the two housings to be easily and quickly separated from one another, usually with one hand, so that the collection bag may be emptied or replaced. In the course of separating the two housings from one another, the plunger moves to the closed position prior to disengagement of the inner section of the actuator housing from the seal on the exterior surface of the plunger housing. This ensures that any fluid within the plunger housing is captured and maintained within its passageway before the two housings are separated from one another. As a result, there is no dripping of fluid from the plunger housing either when the two housings are connected to one another or when they are separated. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    The structure, operation and advantages of the presently preferred embodiment of this invention will become further apparent upon consideration of the following description, taken in conjunction with the accompanying drawings, wherein: 
           [0016]      FIG. 1  is a schematic view of the system of this invention with the catheter inserted in the bladder, and with a collection bag intended for use while a patient is sleeping; 
           [0017]      FIG. 2  is a schematic view of an alternative collection bag for affixing to the leg of a patient; 
           [0018]      FIG. 3  is a schematic view of an alternative collection bag for affixing around the waist of a patient; 
           [0019]      FIG. 4  is perspective view of the plunger housing and actuator housing of the coupler of this invention, shown separated from one another; 
           [0020]      FIG. 5  is an elevational view of the coupler depicted in  FIG. 4 , with the housings separated; 
           [0021]      FIG. 6  is a cross sectional view taken generally along line  6 - 6  of  FIG. 5 ; and 
           [0022]      FIG. 7  is a cross sectional view of the coupler similar to  FIG. 6 , except with the two housings assembled. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0023]    Referring initially to  FIGS. 1-3 , the fluid collection system of this invention generally comprises a catheter  1 , a magnetic valve  7 , a coupler  10  and a collection bag  200 . The catheter  1  depicted in  FIG. 1  is a conventional Foley catheter which is shown inserted through the urethra  2  into the bladder  3 . The catheter  1  includes a balloon-tipped end  4 , a balloon fill line  5  and a valve port  6 . It should be understood that other indwelling catheters may be employed in the fluid collection system of this invention, including the balloonless catheter described in U.S. Pat. No. 6,855,126 to Flinchbaugh, the disclosure of which is incorporated by reference in its entirety herein. 
         [0024]    The outlet of the catheter  1  is connected by tubing  8  to the inlet of magnetic valve  7 . The magnetic valve  7  is preferably of the type described in U.S. Pat. No. 6,673,051 to Flinchbaugh, the disclosure of which is incorporated by reference in its entirety herein. As noted above, the magnetic valve  7  is held in a closed position by magnetic force. The valve  7  is movable to an open position in response to a selected level of fluid pressure, exerted by urine present in the bladder  3 , catheter  1  and tubing  8  located upstream from the valve  7 . When opened, the valve  7  allows urine to wash out of the bladder  3 , i.e. flow out all at one time, along the flow path defined by the catheter  1 , tubing  8  and the valve  7 . Once the fluid pressure is released upstream from the valve  7 , magnetic force returns the valve  7  to the closed position. The valve  7  may therefore be characterized as cyclic, whose frequency of operation is governed by how often the bladder fills with a quantity of urine sufficient to exert enough fluid pressure on the valve  7  to move it to the open position. As described in the &#39;051 Flinchbaugh patent, the magnitude of magnetic force urging the valve  7  to the closed position may be varied to alter the level of fluid pressure required to open the valve  7 , as desired. 
         [0025]    The outlet of valve  7  is coupled by tubing  9  to the inlet side of the coupler  10 , which is described in detail below. As depicted in  FIG. 1 , the outlet side of the coupler  10  is connected to a collection bag  200 . As alternatives to the collection bag  200 , a leg bag  202  is shown in  FIG. 2  and a “belly” bag  204  is illustrated in  FIG. 3 . Each of these bags  200 ,  202 ,  204  has a hollow interior, an inlet  206  coupled to an inlet tube  208  and an outlet  210  connected to a drain valve  212 . A one-way valve or flap valve (not shown) is provided at the inlet  206  of each bag  200 ,  202  and  204  to prevent urine or other liquid from escaping out of the inlet  206  once it enters the interior thereof. The collection bag  200  shown in  FIG. 1  is larger in size than the other two bags  202 ,  204  and is intended primarily for use during sleeping hours of the patient. It has a mounting clip  214  for attachment to a hook or other support  216  on the patient&#39;s bed, nightstand or the like. The leg bag  202  includes adjustable straps  218  and  220  at the top and bottom, respectively, preferably with hook and loop fastening elements at the ends of the straps  218 ,  220  to permit the bag  202  to be secured to the leg of a patient. The “belly” bag  204  is provided with a single mounting strap  222 , having hook and loop fasteners at the free ends, which is sized to fit around and secure to the waist of a patient. When filled, each of these bags  200 ,  202 ,  204  may be separated from the coupler  10 , as described below, and then emptied by operation of the drain valve  212 . 
         [0026]    Referring now to  FIGS. 4-7 , the coupler  10  of this invention includes an actuator housing  12  and a plunger housing  14  which are releasably connected to one another. For purposes of the present discussion, the terms “inner” and “outer” refer to an orientation in the longitudinal direction as depicted in  FIGS. 6 and 7 , i.e. “inner” refers to the center of such Figs. and “outer” refers to a location toward the edges of the sheet on which such Figs. are drawn. The terms “interior” and “exterior” refer to radially spaced locations in  FIGS. 3 and 4 , it begin understood that “interior” surfaces are located toward the center of the housings  12  and  14 , as shown. Additionally, the terms “inlet” and “outlet” refer to the direction of fluid flow through the coupler  10 , e.g. from the left to the right in the orientation of the coupler  10  depicted in  FIGS. 3 and 4 . 
         [0027]    The actuator housing  12  comprises an inner section  16 , a longitudinally spaced outer section  18  and a tapered section  20  between the inner and outer sections  16 ,  18 . The outer section  18  includes a number of longitudinally spaced, protruding barbs  21  which engage the inlet tube  208  of one of the collection bags  200 ,  202  or  204 . The actuator housing  12  is formed with a passageway  22  having an inlet  24  at the inner section  16 . The passageway  22  defines a generally cylindrical-shaped wall  26  with an interior surface  28  and an exterior surface  30 . An annular recess  31  is formed in the inner section  16  which extends inwardly from the exterior surface  30  of the wall  26  toward the interior surface  28 . The passageway  22  reduces in diameter through a transition area  32  along the tapered section  20  of actuator housing  12  to the outer section  18  where it terminates at an outlet  34 . A disc  36  extends radially inwardly into the passageway  22  from the area where the inner and tapered sections  16 ,  20  meet. A plunger actuator  38  is mounted to the center of the disc  36 , extending in a direction toward the inlet  24  of the passageway  22 , and a number of bores  40  are formed in the disc  36  encircling the actuator  38 . It should be noted, for purposes to become apparent below, that the actuator  38  is longitudinally spaced from the inlet  24  of the passageway  22  and the innermost edge  39  of the inner section  16  of the actuator housing  12 . 
         [0028]    The plunger housing  14  generally comprises an inner body  42 , an outer body  44  and a plunger  46 . A locking mechanism  48  is coupled to the plunger housing  14 , as described in detail below. A passageway  50  extends through the plunger housing  14  having an inlet  52  at the outer body  44  and an outlet  54  at the inner body  42 . See  FIG. 4 . The passageway  50  is defined by an interior surface  56  in the plunger housing  14 . The inner body  42  has an exterior surface  58  spaced from the interior surface  56 , and the exterior surface  60  of the outer body  44  is formed with barbs  21  as in the outer section  18  of actuator housing  12 . The outer body  44  of the plunger housing  14  is connected to the tubing  9  extending from the outlet of magnetic valve  7 . 
         [0029]    As best seen in  FIGS. 6 and 7 , the inner body  42  tapers inwardly at the outlet  54  of the passageway  50  forming an elongated seat  62  which receives the leading end  64  of the plunger  46 , when the plunger  46  in the closed position as described below in connection with a discussion of the operation of the coupler  10 . The seat  62  terminates at a shoulder  66  upstream from the outlet  54  of the passageway  50 . A groove extends radially inwardly from the exterior surface  58  of the inner body  42 , adjacent to the outlet end of the inner body  42 , and this groove mounts an O-ring  70  or similar seal. An annular ring  72  extends from the exterior surface  58  of the inner body  42  near its outer end. 
         [0030]    The plunger  46  is formed with a pair of longitudinally spaced ribs  74  and  76 , and a groove adjacent to its leading end  64 . The groove mounts an O-ring  80 , or a similar seal, in position to engage and seal against the seat  62  at the outlet of the inner body  42 . With the plunger  46  in the closed position shown in  FIG. 6 , the rib  76  rests against the shoulder  66  of the inner body  42 . A spring  82  extends along the exterior surface of the plunger  46  between the rib  74  and a shoulder  84  formed in the outlet end of the outer body  44  within the passageway  50 . The longitudinal spacing between the rib  74  and shoulder  84  is chosen so that the spring  82  exerts sufficient force on the plunger  46  to maintain it in the closed position. 
         [0031]    The plunger housing  14  is assembled by placing the spring  82  over the plunger  46  and then inserting the leading end  64  of the plunger  46  into the outlet end of the inner body  42  so that the O-ring  80  on the plunger  46  seals against the seat  62  of the inner body  42 . The inner and outer bodies  42 ,  44  are then connected to one another, such as by adhesive or the like, along a joint  86  formed by mating annular surfaces at the ends of the bodies  42 ,  44 . 
         [0032]    The locking mechanism  48  comprises a lock collar  88  coupled to the inner body  42 , and a release member  90  carried by the lock collar  88 . The lock collar  88  extends around the inner body  42  of the plunger housing  14 , and includes a radially inwardly projecting arm  92  affixed to the exterior surface  58  of the inner body  42  and the exterior surface  60  of the outer body  44  at the joint  86  between the two. An elongated, annular cavity  93  is formed between the lock collar  88  and exterior surface  58  of the inner body  42  which extends from the inner end of the inner body  42  toward the outer body  44 . See  FIG. 6 . The release member  90  consists of an annular ring  94  carried within a slot  96  formed in the lock collar  88 , and a button  98  extending generally perpendicularly to the ring  94 . The button  98  slides within an opening  100  formed in the lock collar  88 . A spring  102 , located within the opening  100  and seated within an annular slot  104  in the lock collar  88 , bears against the button  98  urging it radially outwardly as depicted in  FIGS. 6 and 7 . At least a portion of the annular ring  94  of the release member extends part way into the cavity  93  between the lock collar  88  and the exterior surface  58  of the inner body  42 . 
       System Operation 
       [0033]    It is contemplated that the fluid collection system of this invention may be provided to the attendant at least partially assembled, although assembly can take place after catheterization. When the catheter  1  is positioned within the bladder  3 , the magnetic valve  7  and tubing  8  may be quickly connected to the outlet of the catheter  1  to prevent any dripping. As discussed above, the magnetic valve  7  will not open and permit the passage of urine through it until a selected fluid pressure level is reached within the bladder  3 , catheter  1  and tubing  8 . The outer body  44  of the plunger housing  14  of coupler  10  is coupled to the tubing  9  from the outlet of valve  7 , and the outer section  18  of the actuator housing  12  is coupled to the inlet tube  208  of one of the collection bags  200 ,  202  or  204 . With the actuator housing  12  and plunger housing  14  of the coupler  10  separated from one another, the spring  82  urges the plunger  46  to the closed position in which the O-ring  80  at the leading end  64  of the plunger  46  contacts and seals against the seat  62  formed in the inner body  42  at the outlet  54  of the passageway  50 . This prevents any leakage through the plunger housing  14 . 
         [0034]    In order to connect the two housings  12 ,  14  to one another, and move the plunger  46  to an open position, the wall  26  of the inner section  16  of the actuator housing  12  is inserted into the cavity  93  formed between the locking mechanism  48  and the exterior surface  58  of the inner body  42  of the plunger housing  14 . After a minimum amount of travel along the cavity  93 , the interior surface  28  of the wall  26  engages and seals against the O-ring  70  on the exterior surface  58  of the inner body  42  of the plunger housing  14 . It is important to note that the plunger  46  is in the closed and sealed position at the time of contact between the wall  26  and O-ring  70 . Continued longitudinal movement of the actuator housing  12  relative to the plunger housing  14  causes the actuator  38  to engage the leading end  64  of the plunger  46 . Such movement overcomes the force exerted by the spring  82  tending to close the plunger  46 , and moves the plunger  46  to an open position, spaced from the seat  62 , as shown in  FIG. 7 . With the plunger  46  in the open position, the passageway  50  in the plunger housing  14  communicates with the passageway  22  in the actuator housing  12  thus forming a flow path through the coupler  10 . 
         [0035]    As best seen in  FIG. 7 , the wall  26  of the inner section  16  of actuator housing  12  continues along the cavity  93  until the annular recess  31  formed in the exterior surface  30  of the inner section  16  of actuator housing  12  aligns with the annular ring  94  of the locking mechanism  48 . At that point, the spring  102  urges the ring  94  into the recess  31  thus locking the actuator housing  12  and plunger housing  14  in position relative to one another. See bottom of  FIG. 7 . In the locked position of the two housings  12  and  14 , the plunger  46  is maintained in the open position. 
         [0036]    With the housings  12  and  14  connected and locked together, a leak-proof flow path is provided from the valve  7  to a collection bag  200 ,  202  or  204 . As discussed above, the valve  7  cyclically permits the bladder to washout, all at once, and discharges the urine through tubing  9  into the coupler  10 . The urine passes through the coupler  10  into a collection bag  200 ,  202  or  206 , with the O-ring  70  on the exterior surface  58  of the inner body  42  of plunger housing  14  preventing any leakage from the coupler  10 . 
         [0037]    When it is desired to disconnect the housings  12  and  14  from one another, to empty or replace a collection bag  200 ,  202  or  204 , the release button  98  is pressed radially inwardly which causes the annular ring  94  to disengage the recess  31  in the wall  26  of the inner section  16  of actuator housing  12 . This allows the inner section  16  of actuator housing  12  to be slid out of the cavity  93 . As the actuator housing  12  is moved in a direction away from the plunger housing  14 , the plunger  46  is urged in the same direction by the spring  82 . As soon as the actuator  38  clears the outlet  54  of the passageway  50  in the plunger housing  14 , the plunger  46  assumes its closed position with the O-ring  80  sealed against the seat  62  in the inner body  42  of plunger housing  14 . At this juncture, the wall  26  of the inner section  16  of the actuator housing  12  remains sealed to the O-ring  70  on the exterior surface of the inner body  42  because of the longitudinal spacing between the actuator  38  and the innermost edge  39  of the inner section  16 . This ensures that any fluid residing within the passageway  50  of the plunger housing  14  cannot escape as the housings  12  and  14  are disconnected from one another. The actuator housing  12  is then completely disengaged from the plunger housing  14  to permit a bag  200 ,  202  or  204  connected to the actuator housing  12  to be emptied or replaced. Fluid which entered the passageway  22  of the actuator housing  12  while the housings  12  and  14  were connected to one another would have already passed into a collection bag,  200 ,  202  or  204 , which, as noted above, include a flap valve at the inlet  206  thereof to prevent fluid from exiting the bag  200 ,  202  or  204  at its inlet  206 . After the collection bag is emptied or replaced, the housings  12  and  14  may be re-connected to one another as described above. 
         [0038]    While the invention has been described with reference to a preferred embodiment, it should be understood by those skilled in the art that various changes may be made and equivalents substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.