Abstract:
A convenient, compact and truly closed system drainage and infusion connector valve is disclosed that can be used in conjunction with a wide variety of medical catheters and tubes. The device is designed to take the place of open style adapters and connectors. It has a simple On-Off handle for fluid control and a separately functioning syringe port seal. The device provides in-line irrigation, medication delivery, or syringe decompression/aspiration without disconnect, remaining closed to atmosphere at all times. This closed system protects the clinician from potentially infectious splashback events and the patient from external contamination during suction and drainage, enteral feeding, irrigation/lavage, and medication delivery.

Description:
RELATED APPLICATION  
       [0001]    The inventor claims the full benefit of the following U.S. Provisional Patent Application: “Closed System Drainage And Infusion Connector Valve”., filed Feb. 12, 2002, application No. 60/355,984. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    Various types of drainage, infusion, and enteral delivery tubes are commonly used in medical practice. Typical of these tubes are nasogastric tubes, Salem sump tubes, Levin tubes, naso decompression tubes, PEG tubes, and balloon replacement gastrostomy tubes.  
           [0003]    The nasogastric type tubes are placed nasally down into the stomach or duodenum for drainage or decompression or for the delivery of enteral nutrition. The PEG and gastrostomy type tubes are placed through the abdomen directly into the stomach or duodenum.  
           [0004]    For drainage, these tubes use a connector which attaches to the tube at one end and connects to a suction tubing line and in turn to a drainage receptacle or suction pump delivering a regulated source of suction. Sometimes these suction apparatus are portable and sometimes they are permanently fixed at bedside.  
           [0005]    Often it is necessary to turn off the suction or delivery set in order to administer liquid or dissolved medication. This often requires disconnection of the system which is awkward or cumbersome. In order to avoid disconnection, a prior art invention was conceived called commercially the “Lopez Valve” which is U.S. Pat. No. 4,895,562 issued January 1990 and similar U.S. Pat. No. 4,790,832 issued December 1988. The “Lopez Valve” uses a 4-way stopcock arrangement clearly depicted in FIGS.  3 , 4 , 5 , 6  of the &#39;562 patent and fully described in that disclosure.  
           [0006]    In one of the 4-way positions, the drainage line could be shut off and a piston irrigation syringe attached to the 4-way valve to deliver liquid medications. This arrangement eliminated the need to disconnect the suction tubing line or delivery set from the indwelling tube. While the “Lopez Valve” of the &#39;562 patent was an advancement, it still has several deficiencies. The 4-way stopcock is somewhat confusing to find the right position. If the stopcock handle is left in the syringe infusion mode, stomach contents which are pressurized can spew out the syringe port. In summary, the “Lopez Valve” is dependent upon the user to a great extent in order to function and is not a truly closed system since the syringe port can easily be left open to atmosphere. Further, the 4-way valve has a small passageway wherein infused dissolved solid and crushed medication can easily become clogged in the “Lopez Valve”. Spattering or spewing of potentially infectious stomach contents out the syringe port of the “Lopez Valve” can also be a problem when the syringe is disconnected and if the valve is not immediately closed prior to disconnection of the syringe. The syringe port on the “Lopez Valve” also sticks out the side of the 4-way handle making it awkward and prone to catching on the patient&#39;s garment or bedclothes. Most recently, tethered caps have been added to the commercial “Lopez Valve” product, but this has increased confusion in using the device and added bulk to the overall size of the device. In addition, U.S. Pat. Nos. 6,240,960 issued June 2001 and 6,481,462 issued November 2002 to Fillmore describe noncommercial single function valve constructions similar to but more complex than these of Lopez.  
         SUMMARY OF THE INVENTION  
         [0007]    The difficulties and problems discussed above have been obviated by the present invention which is a truly closed system connector valve and much simpler and easier to use. The present connector invention comprises four components easily assembled into a unitized closed system drainage and infusion connector valve which can attach to a wide variety of catheters and tubes. It comprises a simple On-Off 2-way turn handle valve with a separate functioning built in syringe port. In essence, the syringe port is not part of the On-Off valve and functions automatically to open upon insertion of the syringe tip and to automatically close upon removal of the syringe tip. In summary, the connector valve remains closed to atmosphere at all times.  
           [0008]    Splattering of stomach contents is eliminated and dissolved medications can be delivered without clogging. A resilient adapter can be added to the proximal end of the connector valve permitting connection to all enteral delivery sets whether pump or gravity as well as bolus syringe feeding.  
           [0009]    The closed system connector valve is streamlined, easy to use and understand, and inexpensive to manufacture.  
           [0010]    It is therefore a primary object to provide a closed system drainage and infusion connector valve which is truly a closed system device.  
           [0011]    It is another object to provide a connector valve which separates the function of On-Off and syringe infusion.  
           [0012]    It is another object to provide a connector valve which prevents splashback through the syringe port.  
           [0013]    It is another object to provide a streamlined in-line design connector valve which is easy to use as a closed system adapter for enteral feeding tubes.  
           [0014]    Other objects will become readily apparent upon review of the drawings and detailed description of the invention.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]    [0015]FIG. 1 is a top view of the prior art “Lopez Valve” in its commercial form as depicted in U.S. Pat. No. 4,895,562.  
         [0016]    [0016]FIG. 2 is at top view of the closed system drainage and infusion connector valve of the present invention.  
         [0017]    [0017]FIG. 3 is a top view of the On-Off handle of the closed system drainage and infusion connector valve.  
         [0018]    [0018]FIG. 4 is a cross sectional view of the connector valve shown in its normal mode of operation with the handle positioned in the on or open position and the syringe port seal in its normally closed sealed position.  
         [0019]    [0019]FIG. 5 is a cross sectional view of the connector valve in its valve turned to the off or closed position and insertion of a piston syringe into the syringe port seal.  
         [0020]    [0020]FIG. 6 is a cross sectional view of the connector valve with a resilient adapter added to its proximal end.  
         [0021]    [0021]FIG. 7 is a top view of the connector valve as part of the Directions For Use in its feeding procedure mode.  
         [0022]    [0022]FIG. 8 is a top view of the connector valve as part of the Directions For Use in its drainage and suction procedure mode.  
         [0023]    [0023]FIG. 9 is a top view of the connector valve as part of the Directions For Use in its irrigation/lavage and medication delivery procedure mode.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0024]    [0024]FIG. 1 depicts prior art “Lopez Valve”  10  having an injection molded body  11  with a frontal stepped tubing connector portion  12  and a rearward suction connector  13 . Fitted into body  11  is 4-way stopcock  14  having side syringe port  15  as part of the 4-way stopcock. Cap  16  closes off syringe port  15 . As can be seen, when 4-way stopcock  14  is in an open positioned  15 , stomach contents can exit out syringe port  15  at any time the syringe is not connected to port  15 . Likewise, if separate loose cap  16  is lost and the valve  10  is inadvertently turned to open the syringe port  15 , stomach contents can again exit out port  15 . These above-described drawbacks of the “Lopez Valve” present significant risks to caregivers utilizing this device and are eliminated by the construction of the present invention as hereinafter described.  
         [0025]    [0025]FIG. 2 is a top view of closed system connector valve  17  preferably having an injection molded one-piece clear polycarbonate body  18 . Body  18  has a built-in distal gradually increasing in diameter stepped barbed connector  19  which can be attached to a wide variety of indwelling tubes or catheters. Proximally located on body  18  is suction connector  20  attachable to a drainage receptacle or drainage tubing line. Fitted into body  18  is On-Off handle  21  shown in its normal on or open mode. Syringe port  22  has entrance fitting  23  which locks in a resilient silicone molded cup-shaped seal  24  which has a slit  25  in its upper surface which slit is normally biased to a closed position. The seal  24  is thus incorporated as part of body  18 .  
         [0026]    [0026]FIG. 3 shows On-Off handle  21  being manually turned from its normally fixed first on position to its second fixed off position. Handle  21  is keyed into body  18  such that there are built in stops which perfectly align the handle 90 degrees to either its simple on or off position which is easily comprehended by the user.  
         [0027]    [0027]FIG. 4 is a cross sectional view of connector valve  17  wherein handle  21  is positioned to its first fixed on position. Body  18  has molded in linear central passageway  26  with inlet distal opening  27  and proximal exit  28  which forms a fluid communication path between distal opening  27  and proximal exit  28 . Opening  27  permits fluid and air communication with any tube or catheter and exit  28  permits fluid and air to flow directly and unobstructively through passageway  26  and out to a drainage receptacle.  
         [0028]    Proximal connector  20  similar in design to distal connector  19  will attach to any suction tubing and to any source of suction or to gravity drainage or drainage bag or receptacle.  
         [0029]    Handle  21  has one large lumen cross-bore  29  and molded in undercut  30  which snap fits handle  21  into body  18 .  
         [0030]    Handle  21  has internal barrel  31  which forms a close tolerance fit with cross passage  32  within body  18 . Undercut  30  forms a downward compression fit at tapered wedge  33  on handle  21  to form a liquid and airtight seal between handle  21  and body  18 .  
         [0031]    Handle  21  will rotate barrel  31  90 degrees within passage  32  to either open or close off passageway  26  from exit  28  as an On-Off shut off means. When handle  21  is positioned to its first fixed on position, there is a free unencumbered flow of fluid or air through passageway  26  from distal opening  27  right on through out exit  28 .  
         [0032]    When handle  21  is positioned or turned to its second fixed off position as shown in FIG. 3, then fluid and air flowing through passageway  26  is blocked from exit  28 .  
         [0033]    Formed as part of body  18  is upright collar  34  into which is fitted silicone molded slit seal  24 . Permanently locking in slit seal  24  is entrance fitting  23  which is molded from polycarbonate. Slit seal  24  and entrance fitting  23  now form syringe port  22 . Fitting  23  is sonic welded or solvent bonded to collar  34 . Fitting  23  slightly compresses downward on top of seal  24  to form a liquid tight seal between fitting  23  and seal  24 , and this downward compression also forces slit  25  in a normally biased liquid tight inward closed position. FIG. 4 thus depicts seal  24  in its normally biased sealed closed to atmosphere seal.  
         [0034]    Fitting  23  has tapered friction fit opening  35  which will accept any piston or irrigation syringe tip. Collar  34  retains slit seal  24  such that slit  25  is normally biased closed to prevent any loss of fluid or air out slit seal  24 . In normal operation, the closed system connector valve  17  is directly attached to any catheter or tube by distal connector  19  and also attached proximally to a tubing line by connector  20 . Once connected, the connector valve  17  forms a closed system device such that fluid or air cannot escape from the valve.  
         [0035]    When suction is applied and the valve is normally positioned to its first fixed open position, fluid or air will flow freely through passageway  26  and into a drainage receptacle. If the patient needs to be disconnected from the suction line and wants to become ambulatory, then the handle is turned to its second fixed off position and the system remains closed. Patient can now ambulate with the connector valve as part of the indwelling tube without fear of spillage. Reconnection to the suction line can take place at any future time. As such, the system remains closed at all times.  
         [0036]    Often liquid or dissolved medications may want to be administered without having to disconnect closed connector valve  17  from the catheter or suction line by using a  60  cc catheter tip piston or irrigation syringe.  
         [0037]    [0037]FIG. 5 depicts piston syringe  37  having syringe tip  36  opening slit seal  24  by direct insertion of syringe tip  36  into slit seal  24 . Fitting  23  having friction fit opening  35  is so dimensioned to provide a friction fit with syringe nozzle  38  such that tip  36  will slightly open slit  25  on silicone slit seal  24 . This is so syringe nozzle  38  will form a rigid solid friction fit with tapered opening  35 . This fit limits the insertion of nozzle  38  such that tip  36  will not overstretch or overpower slit seal  24  to insure repeated use of syringe port  22  without failure.  
         [0038]    In order to accommodate the large taper of 60 cc catheter tip syringe nozzle  38 , silicone seal  24  must be about 0.500 inches in diameter and slit  25  must be at least 0.325 inches in length. However, syringe port  22  can easily be designed to accommodate the smaller nozzles on luer tip syringes by making silicone seal  24  smaller in diameter and having slit  25  shorter in length. Also in a luer tip syringe design, entrance fitting  23  can have a flat flush with the silicone seal  24  top design or a shorter in height opening  35 . The cylindrical hat-shaped configuration of the seal enhances moldability as well as placement into the fitting  23 ; however, alternate shaped seals could be used, e.g., a simple flat disc shape. Also, the directional orientation of the slit  25  with respect to the fitting  23  can be modified from that shown.  
         [0039]    When medication delivery is desired, handle  21  is turned to its off position which closes off cross bore  29  and prevents and blocks fluid or air flow out exit  28  as shown in FIG. 5.  
         [0040]    Medication can now be infused directly in front of handle  21  and directly into passageway  26  in front of handle  21 . The function of syringe port  22  and handle  21  are completely separate and not dependent on each other for function.  
         [0041]    Slit seal  24  will automatically open and close shut by insertion and removal of syringe tip  36  to maintain a closed system at all times. Further, since syringe fluid  39  flows directly into passageway  26  there is no clogging of handle  21  or cross bore  29  with undissolved medication.  
         [0042]    Reduced clogging in passageway  26  is enhanced by incorporation of a fluid-mixing chamber  43  directly downstream of syringe tip  36 . Syringe tip  36  fluid flows into the relatively large diameter fluid mixing chamber  43  to create a turbulent swirling action in chamber  43  to keep crushed and dissolved granular medication in suspension and flowing freely into passageway  26 .  
         [0043]    Once syringe  37  is removed then handle  21  can return to its normal first fixed open position as depicted in FIG. 4 while the entire closed system connector valve  17  remains closed to atmosphere to all times. Since slit seal  24  functions automatically, there is no fear of splashing or splattering of stomach contents. Also, there is no need for a separate cap for syringe port  22  or a tethered cap for proximal connector  20 .  
         [0044]    [0044]FIG. 6 shows the addition of PVC or silicone resilient adapter  40  to proximal connector  20  and forms a grip fit with barbed edges  42  on connector  20 . Opening  41  on adapter  40  will now accept any enteral delivery set whether pump or gravity as well as any bolus syringe. Frontal connector  19  will attach directly to a wide variety of any size indwelling gastrostomy tubes due to its gradually increasing diameter steps.  
         [0045]    Adapter  40  can be removed and the connector valve  17  returns to its original usage if desired.  
         [0046]    [0046]FIGS. 7, 8, and  9  are top views of connector  17  to be used in conjunction with the following Directions For Use to make the directions easily understood.  
         [0047]    [0047]FIG. 7 shows catheter connector end  44 , feeding or patient tube  45 , feeding set  46 , flexible adapter  47 , and handle  48  wherein connector valve  17  is shown in its feeding procedure mode.  
         [0048]    [0048]FIG. 8 shows flexible adapter  47  removed from proximal end  49  and end  49  connectable to suction tubing  50  wherein connector valve  17  is shown in its drainage and suction procedure mode.  
         [0049]    [0049]FIG. 9 shows handle  48  turned 90° to its closed position and catheter syringe tip  51  ready to be inserted into syringe port seal  52  wherein connector valve  17  is shown in its irrigation/lavage and medication delivery procedure mode.  
         [0050]    Directions for Use  
         [0051]    Feeding Procedure (See FIG. 7)  
         [0052]    Connector Valve  17  Replaces Existing Open Style Feeding Adapters  
         [0053]    1. Attach catheter connector end to feeding tube.  
         [0054]    2. Insert feeding set or bolus syringe tip into flexible adapter.  
         [0055]    3. Turn handle to the ON position to deliver feeding formula.  
         [0056]    4. Turn handle to the OFF position when feeding is complete, and remove feeding set from flexible adapter.  
         [0057]    Drainage and Suction Procedure (See FIG. 8)  
         [0058]    Connector Valve  17  Replaces 5-in-1 Connectors  
         [0059]    1. Attach catheter connector end to patient tube.  
         [0060]    2. Remove flexible adapter and attach suction tubing directly to connector valve.  
         [0061]    3. Turn handle to the ON position to suction or drain.  
         [0062]    4. Turn handle to the OFF position and remove suction tubing.  
         [0063]    Irrigation/Lavage and Medication Delivery Procedure (See FIG. 9)  
         [0064]    1. Turn handle to the OFF position.  
         [0065]    2. Hold the connector valve securely and push catheter tip syringe firmly into syringe port seal until tight.  
         [0066]    3. Dispense fluid or medication into the connector valve.  
         [0067]    4. Remove syringe. The syringe port seal will close automatically.  
         [0068]    To ambulate patient, turn handle to OFF position and disconnect feeding set or suction tubing. Patient can then ambulate as desired. Feeding and drainage can be resumed as needed by repeating above procedures. The connector valve remains as part of catheter according to accepted medical standards.  
         [0069]    As can be seen, the present invention overcomes many of the objections of the prior art and provides a truly closed system connector valve for feeding, drainage and suction, and the infusion of irrigation/lavage and medication delivery.  
         [0070]    Many variations in design, materials, and configurations can take place without departing from the broad scope of the underlying invention.